Doctor Fred L. Pasternack, Appellant,v.Laboratory Corporation of America Holdings,, et al., Respondents.BriefN.Y.June 1, 2016To Be Argued By: CYNTHIA S. ARATO Time Requested: 30 Minutes CTQ-2015-00004 United States Court of Appeals for the Second Circuit Case No. 14-4101-cv Court of Appeals STATE OF NEW YORK DOCTOR FRED L. PASTERNACK, Plaintiff-Appellant, —against— LABORATORY CORPORATION OF AMERICA HOLDINGS, a/ k /a LABCORP, CHOICEPOINT, INC., Defendants-Respondents. BRIEF FOR PLAINTIFF-APPELLANT d CYNTHIA S. ARATO DANIEL J. O’NEILL SHAPIRO ARATO LLP 500 Fifth Avenue, 40th Floor New York, New York 10110 Telephone: (212) 257-4880 Facsimile: (212) 202-6417 Attorneys for Plaintiff-Appellant Doctor Fred L. Pasternack February 12, 2016 TABLE OF CONTENTS PAGE TABLE OF AUTHORITIES .................................................................................... iv INTRODUCTION ..................................................................................................... 1 JURISDICTIONAL STATEMENT .......................................................................... 4 QUESTIONS CERTIFIED FOR REVIEW .............................................................. 5 STATEMENT OF FACTS ........................................................................................ 6 A. The Parties ................................................................................................. 6 B. The FAA’s Drug Testing Regime ............................................................. 7 C. The Consequences Of A False Positive Test Result Or Wrongfully Being Deemed A Refusal To Test ....................................... 11 D. Defendants’ Faulty Administration Of Pasternack’s Drug Test ............. 12 1. LabCorp Failed to Follow the “Shy Bladder” Procedures or to Tell Pasternack about the Consequences of Leaving the Facility ........................................................................................ 12 2. ChoicePoint Erroneously and Unreasonably Reported a Failure to Test ................................................................................... 15 E. The FAA’s Actions And Pasternack’s Successful Administrative Challenge ................................................................................................. 16 F. Procedural History................................................................................... 19 SUMMARY OF ARGUMENT ............................................................................... 20 ARGUMENT ........................................................................................................... 21 ii POINT I. THE FIRST CERTIFIED QUESTION SHOULD BE REFORMULATED ....................................................................................... 21 POINT II. UNDER LANDON, FAA DRUG TEST ADMINISTRATORS OWE A COMMON-LAW DUTY OF CARE TO THEIR TEST SUBJECTS, AND A VIOLATION OF THE APPLICABLE FEDERAL REGULATIONS AND GUIDELINES IS EVIDENCE THAT THE ADMINISTRATOR FAILED TO MEET THE REQUISITE STANDARD OF CARE .......................................................... 27 A. Drug Test Administrators Owe Their Test Subjects A Common-Law Duty Of Care Under New York Law .............................. 27 1. This Court Recognized the General Duty of Care in Landon ........... 27 2. The Common-Law Duty of Care Applies Equally to All Drug Test Administrators, Regardless of the Mandate Under Which They Are Conducting the Tests ........................................................ 31 B. The Drug Testing Regulations And Guidelines Promulgated By The FAA And DOT Inform The Standard Of Care ................................ 37 C. The DOT Regulations And Guidelines May Also Independently Give Rise To A Duty Of Care ................................................................. 41 D. It Is Irrelevant That There Is No Private Right Of Action Under The FAAct ............................................................................................... 43 POINT III. THIS COURT SHOULD REAFFIRM THAT FRAUD DOES NOT DEPEND ON WHETHER THE PLAINTIFF HIMSELF RELIED ON THE DEFENDANT’S MISREPRESENTATION AS LONG AS THE PLAINTIFF WAS HARMED BY THE DEFENDANT’S DELIBERATE DECEIT ............................................................................... 45 A. Third-Party Reliance Is The Law In New York ...................................... 46 B. There Is No Principled Basis To Limit Fraud Claims To Those In Which The Defendant’s Deceit Caused The Plaintiff To Be Injured By His Own Reliance, And Not By The Reliance Of A Third Party ............................................................................................... 49 iii 1. “Fraud” Embraces Circumstances in Which the Plaintiff Was the Foreseeable Victim of a Deceit Practiced on a Third Party. It Is a Wrong That Demands a Remedy ................................................... 49 2. The Tort of Tortious Interference with Business Relations Does Not Displace Recovery in Fraud ..................................................... 52 3. Allowing Fraud Claims Based On “Third-Party Reliance” Does Not Unreasonably Expand Liability ................................................. 54 CONCLUSION ........................................................................................................ 56 ADDENDUM ................................................................................................. ADD-1 iv TABLE OF AUTHORITIES PAGE Cases Aymes v. Gateway Demolition Inc., 30 A.D.3d 196, 197 (1st Dep’t 2006) .................................................................. 48 Babbitt v. O’Doherty, Docket No. SE-18981, 2011 WL 1086073 (N.T.S.B. Jan. 27, 2011) ................. 18 Babbitt v. Rojas, NTSB Order No. EA-5496, 2009 WL 5213712 (N.T.S.B. Dec. 30, 2009) ........ 18 Baker v. Abo, Civ. 01-1248 JRTJSM, 2003 WL 21639151 (D. Minn. July 2, 2003) ................ 29 Balistrieri v. Express Drug Screening, LLC, No. 04-C-0989, 2008 WL 906236 (E.D. Wis. Mar. 31, 2008) ..................... 26, 33 Barenboim v. Starbucks Corp., 21 N.Y.3d 460 (2013) ............................................................................................ 5 Bauer v. Female Acad. of Sacred Heart, 97 N.Y.2d 445 (2002) .......................................................................................... 24 Berry v. Nat’l Med. Servs., 205 P.3d 745 (Kan. Ct. App. 2009) ........................................................ 30, 32, 33 Braverman v. Bendiner & Schlesinger, Inc., 121 A.D.3d 353 (2d Dep’t 2014) .................................................................. 38, 39 Briarpatch Ltd., L.P. v. Frankfurt Garbus Klein & Selz, P.C., 13 A.D.3d 296 (1st Dep’t 2004) .......................................................................... 48 Bridge v. Phoenix Bond & Indem. Co., 553 U.S. 639 (2008) ............................................................................................. 50 Buxton Mfg. Co. v. Valiant Moving & Storage, Inc., 239 A.D.2d 657 (2d Dept. 1997) .................................................................. 47, 54 v Carvel Corp. v. Noonan, 3 N.Y.3d 182 (2004) ............................................................................................ 53 Cement & Concrete Workers Dist. Council Welfare Fund v. Lollo, 148 F.3d 194 (2d Cir. 1998) ................................................................................. 48 Chapman v. LabOne, 460 F. Supp. 2d 989 (S.D. Iowa 2006) ................................................................ 33 Chevron Corp. v. Donziger, 871 F. Supp. 2d 229 (S.D.N.Y. 2012) .......................................................... 48, 54 Cipriano v. State, 171 A.D.2d 169 (3d Dep’t 1991) ......................................................................... 25 City of New York v. Smokes-Spirits.com, Inc., 541 F.3d 425 (2d Cir. 2008) ................................................................................. 48 Coleman v Town of Hempstead, 30 F. Supp. 2d 356 (E.D.N.Y. 1999) ...................................................... 30, 32, 33 Cooper v. Weissblatt, 277 N.Y.S. 709 (2d Dep’t 1935) ............................................................. 47, 48, 54 Cuffy v. City of New York, 69 N.Y.2d 255 (1987) .......................................................................................... 44 Cutler v. Quality Terminal Servs., LLC, No. 08-cv-6630, 2009 WL 4674124 (N.D. Ill. Dec. 4, 2009) ............................. 26 Darby v. Compagnie Nat’l Air France, 96 N.Y.2d 343 (2001) .......................................................................................... 23 Desser v. Schatz, 182 A.D.2d 478 (1st Dept. 1992) ............................................................ 47, 48, 54 Drake v. Delta Air Lines, Inc., 147 F.3d 169 (2d Cir. 1998) ................................................................................. 11 vi Drake v. Lab. Corp. of Am. Holdings, 458 F.3d 48 (2d Cir. 2006) .......................................................... 36, 42, 43, 44, 45 Drake v. Lab. Corp. of Am. Holdings, 02-CV-1924 (FB)(RML), 2007 WL 776818 (E.D.N.Y. Mar. 13, 2007) ....................................................................... 30, 32, 33 Duncan v Afton, Inc., 991 P.2d 739 (Wyo. 1999) ...................................................................... 30, 32, 33 Eaton, Cole & Burnham Co. v. Avery, 83 N.Y. 31 (1880) ................................................................................................ 48 Elliott v. City of New York, 95 N.Y.2d 730 (2001) .......................................................................................... 24 Elliott v. Lab. Specialists, Inc., 588 So. 2d 175 (La. Ct. App. 1991) ..................................................................... 30 Espinal v. Melville Snow Contractors, Inc., 98 N.Y.2d 136 (2002) ................................................................................... 22, 28 Ferguson v. Hanson Aggregates New York, Inc., 103 A.D.3d 1174 (4th Dep’t 2013) ...................................................................... 25 Fuentes v. Bd. of Educ. of City of New York, 12 N.Y.3d 309 (2009) ............................................................................................ 5 Garelick v. Carmel, 141 A.D.2d 501 (2d Dep’t 1988) ......................................................................... 48 Garlick v. Quest Diagnostics, Inc., No. 06-cv-6244 (DMC), 2009 WL 5033949 (D.N.J. Dec. 14, 2009) ................. 29 Giglio v. Saratoga Care, Inc., 117 A.D.3d 1143 (3d Dep’t 2014) ....................................................................... 37 Good Luck Prod. Co. v. Crystal Cove Seafood Corp., 60 F. Supp. 3d 365 (E.D.N.Y. 2014) ............................................................ 48, 54 vii Goodyear Tire & Rubber Co. v. Kirk’s Tire & Auto Servicecenter of Haverstraw, Inc., No. 02 Civ. 0504 (RCC), 2005 WL 550940 (S.D.N.Y. Mar. 9, 2005) ......................................................... 41 Greenberg, Trager & Herbst, LLP v. HSBC Bank USA, 17 N.Y.3d 565 (2011) .......................................................................................... 22 Hamilton v. Beretta U.S.A. Corp., 96 N.Y.2d 222 (2001) .......................................................................................... 35 Heard v. City of New York, 82 N.Y.2d 66 (1993) ............................................................................................ 37 Ishikawa v. Delta Airlines, Inc., 343 F.3d 1129 (9th Cir. 2003) ................................................................ 25, 43, 45 Kievman v. Philip, 84 A.D.3d 1031 (2d Dep’t 2011) ......................................................................... 37 Kindernay v. Hillsboro Area Hosp., 366 Ill. App. 3d 559 (2006) .......................................................................... 25, 26 King v. Garfield County Pub. Hosp. Dist. No. 1, 17 F. Supp. 3d 1060 (E.D. Wash. 2014) .............................................................. 29 Lacondeguy v. Adapa, No. 2:10-CV-1917-JAM-KJM, 2011 WL 9572 (E.D. Cal. Jan. 3, 2011) ........... 26 Landon v. Kroll Laboratory Specialists, Inc., 22 N.Y.3d 1 (2013) ...................................................................................... passim Landon v. Kroll Lab. Specialists, Inc., 91 A.D.3d 79 (2d Dep’t 2011) ............................................................................. 35 Landry v. Gen. Motors Corp., 210 A.D.2d 898 (4th Dep’t 1994) ........................................................................ 25 Lewis v. Aluminum Co. of Am., 588 So. 2d 167 (La. Ct. App. 1991) .............................................................. 30, 34 viii Liberty Life Assur. Co. of Boston v. Bahan, No. 09 Civ. 4715 (JSR), 2010 WL 3431147 (S.D.N.Y. Aug. 23, 2010) ............. 48 Lopes v. Rostad, 45 N.Y.2d 617 (1978) .......................................................................................... 41 Lorberblatt v. Gerst, 10 N.Y.2d 244 (1961) ........................................................................................... 23 Lynn v. Mount Sinai Med. Ctr., Inc., 692 So. 2d 1002 (Fla. Dist. Ct. App. 1997) ......................................................... 30 Madry v. Heritage Holding Corp., 96 A.D.3d 1022 (2d Dep’t 2012) ......................................................................... 24 Martin v. Herzog, 228 N.Y. 164 (1920) ............................................................................................ 23 Mayle v. Felix, 545 U.S. 644 (2005) ............................................................................................. 52 McKinney v. Bellevue Hosp., 183 A.D.2d 563 (1st Dep’t 1992) ........................................................................ 37 McLean v. Triboro Coach Corp., 302 N.Y. 49 (1950) .............................................................................................. 37 McSweeney v. Rogan, 209 A.D.2d 386 (2d Dep’t 1994) ......................................................................... 41 Miller v. Paris Cmty. Hosp., No. 07-CV-2195, 2009 WL 2050996 (C.D. Ill. July 13, 2009) .......................... 26 My First Shades v. Baby Blanket Suncare, 914 F. Supp. 2d 339 (E.D.N.Y. 2012) ................................................................. 48 N.B. Garments (PVT), Ltd. v. Kids Int’l Corp., No. 03 Civ. 8041(HB), 2004 WL 444555 (S.D.N.Y. Mar. 10, 2004) .......... 48, 54 ix Nallan v. Helmsley-Spear, Inc., 50 N.Y.2d 507 (1980) .......................................................................................... 37 Nichter v. Hartley, 192 A.D.2d 842 (3d Dep’t 1993) ......................................................................... 24 O’Brien v. Argo Partners, Inc., 736 F. Supp. 2d 528 (E.D.N.Y. 2010) ................................................................. 48 Palka v. Servicemaster Mgmt. Servs. Corp., 83 N.Y.2d 579 (1994) ................................................................................... 22, 34 Palsgraf v. Long Island R.R. Co., 248 N.Y. 339 (1928) ............................................................................................ 34 Pasley and Another v. Freeman, 100 Eng. Rep. 450 (K.B. 1789); 3 T.R. 51 ......................................................... 51 Pasternack v. Huerta, 513 F. App’x 1 (D.C. Cir. 2013) ................................................................... 17, 18 Pasternack v. Nat’l Transp. Safety Bd., 596 F.3d 836 (D.C. Cir. 2010) ................................................................ 14, 17, 18 Payne v. Tennessee, 501 U.S. 808 (1991) ............................................................................................. 49 People v. Mancuso, 255 N.Y. 463 (1931) ..................................................................................... 49, 50 In re Pharm. Indus. Average Wholesale Price Litig., MDL No. 1456, No. 01-12257-PBS, 2007 WL 1051642 (D. Mass. Apr. 2, 2007) .......................................................................... 48, 54, 55 Phillips v. Quality Terminal Servs., LLC, No. 08-cv-6633, 2009 WL 4674051 (N.D. Ill. Dec. 4, 2009) ............................. 33 Piper v. Hoard, 107 N.Y. 73 (1887) ..................................................................... 46, 47, 48, 54, 55 x Prestige Builder & Mgmt. LLC v. Safeco Ins. Co. of Am., 896 F. Supp. 2d 198 (E.D.N.Y. 2012) .......................................................... 48, 54 Quisenberry v. Compass Vision, Inc., 618 F. Supp. 2d 1223 (S.D. Cal. 2007) ................................................................ 29 Ragsdale v. Mount Sinai Med. Ctr. of Miami, 770 So. 2d 167 (Fla. Dist. Ct. App. 2000) ........................................................... 30 Rice v. Manley, 66 N.Y. 82 (1876) ................................................................. 46, 47, 48, 50, 51, 55 Rodriguez v. Lab. Corp. of Am. Holdings, 13 F. Supp. 3d 121 (D.D.C. 2014) ....................................................................... 29 Rozell v. Rozell, 281 N.Y. 106 (1939) ............................................................................................ 51 Ruffing v. Union Carbide Corp., 308 A.D.2d 526 (2d Dep’t 2003) .................................................................. 47, 54 Sanchez v. State of New York, 99 N.Y.2d 247 (2002) .......................................................................................... 23 Santiago v. Greyhound Lines, Inc., 956 F. Supp. 144 (N.D.N.Y. 1997) ...................................................................... 30 Scotto v. Marra, 23 A.D.3d 543 (2d Dep’t 2005) ........................................................................... 24 Sharpe v St. Luke’s Hosp., 821 A.2d 1215 (Pa. 2003) ....................................................................... 30, 32, 33 Silkwood v. Kerr-McGee Corp., 464 U.S. 238 (1984) ............................................................................................. 45 Siotkas v. LabOne, Inc., 594 F. Supp. 2d 259 (E.D.N.Y. 2009) .................................................... 25, 30, 32 xi Spiker v. Sanjivan PLLC, No. CV-13-00334-PHX-GMS, 2013 WL 5200209 (D. Ariz. Sept. 16, 2013) ............................................................. 25, 32, 36, 40, 45 State Farm Mut. Auto. Ins. Co. v. Fitzgerald, 25 N.Y.3d 799 (2015) .......................................................................................... 49 State v. Donald DD., 24 N.Y.3d 174 (2014) .......................................................................................... 49 Stinson v. Physicians Immediate Care, Ltd., 269 Ill. App. 3d 659 (2d Dist. 1995) .................................................................... 30 Tenuto v. Lederle Labs., Div. of Am. Cyanamid Co., 90 N.Y.2d 606 (1997) .......................................................................................... 22 Thome v. Alexander & Louisa Calder Found., 70 A.D.3d 88 (1st Dep’t 2009) ............................................................................ 53 Trimarco v. Klein, 56 N.Y.2d 98 (1982) ............................................................................................ 24 Uhr v. E. Greenbush Cent. Sch. Dist., 94 N.Y.2d 32 (1999) ............................................................................................ 44 Union Carbide Corp. v. Montell N.V., 9 F. Supp. 2d 405 (S.D.N.Y. 1998) ........................................................ 48, 54, 55 Warshaw v. Concentra Health Servs., 719 F. Supp. 2d 484 (E.D. Pa. 2010) .................................................................. 29 Webster v. Psychemedics Corp., No. 2010-01087-COA-R3-CV, 2011 WL 2520157 (Tenn. Ct. App. June 24, 2011) ............................................................................ 29 Williams v. Nat’l R.R. Passenger Corp., 16 F. Supp. 2d 178 (D. Conn. 1998) .................................................................... 29 Zumpano v. Quinn, 6 N.Y.3d 666 (2006) ............................................................................................ 53 xii Statutes, Regulations and Rules 49 U.S.C. § 40120 .................................................................................................... 42 49 U.S.C. § 44709 .................................................................................................... 11 49 U.S.C. § 45102 ...................................................................................................... 7 10 C.F.R. § 26.4 ....................................................................................................... 10 10 C.F.R. § 26.31 ..................................................................................................... 10 10 C.F.R. § 26.415 ................................................................................................... 10 14 C.F.R. § 67.107 ................................................................................................... 11 14 C.F.R. § 120.103 ................................................................................................... 7 14 C.F.R. § 120.105 ................................................................................................... 7 46 C.F.R. § 16.113 ................................................................................................... 10 49 C.F.R. §§ 40.1 ....................................................................................................... 8 49 C.F.R. § 40.3 ...................................................................................... 8, 10, 26, 36 49 C.F.R. § 40.15 ....................................................................................................... 8 49 C.F.R. § 40.27 ........................................................................................ 12, 43, 45 49 C.F.R. § 40.33 ................................................................................................ 8, 34 49 C.F.R. § 40.43 ....................................................................................................... 9 49 C.F.R. § 40.61 ..................................................................................................... 10 49 C.F.R. § 40.83 ....................................................................................................... 9 49 C.F.R. § 40.87 ....................................................................................................... 9 xiii 49 C.F.R. § 40.121 .............................................................................................. 9, 34 49 C.F.R. § 40.123 .................................................................................. 8, 10, 16, 36 49 C.F.R. § 40.129 ..................................................................................................... 9 49 C.F.R. § 40.131 ..................................................................................................... 9 49 C.F.R. § 40.151 ................................................................................................... 15 49 C.F.R. § 40.191 ................................................................................................... 14 49 C.F.R. § 40.193 ................................................................................................... 13 49 C.F.R. § 40.343 ..................................................................................................... 8 49 C.F.R. § 40.355 ................................................................................ 12, 15, 43, 45 49 C.F.R. § 199.5 ..................................................................................................... 10 49 C.F.R. § 219.701 ................................................................................................. 10 49 C.F.R. § 382.105 ................................................................................................. 10 49 C.F.R. § 655.51 ................................................................................................... 10 C.P.L.R. 213 ............................................................................................................. 53 C.P.L.R. 214 ............................................................................................................. 53 Section 500.27 of the Rules of Practice of the Court of Appeals for the State of New York ......................................................... 4 Other Authorities United States Department of Transportation, Urine Specimen Collection Guidelines, Revised Dec. 2006 ....................... passim xiv Anti-Drug Program for Personnel Engaged in Specified Aviation Activities, 53 Fed. Reg. 47024-01 (Nov. 21, 1988) .............................................................. 39 Omnibus Transportation Employee Testing Act of 1991, Pub. L. No. 102–143, § 2(6), 105 Stat. 953 (1991) ...................................... 39, 42 Procedures for Transportation Workplace Drug Testing Programs, 54 Fed. Reg. 49854-01 (Dec. 1. 1989) .......................................................... 40, 42 Procedures for Transportation Workplace Drug and Alcohol Testing Programs, 64 Fed. Reg. 69076-01 (Dec. 9, 1999) .......................................................... 11, 40 Procedures for Transportation Workplace Drug and Alcohol Testing Programs, 65 Fed. Reg. 79462-01 (Dec. 19, 2000) ................................ 10, 11, 15, 36, 40, 42 RESTATEMENT (SECOND) OF TORTS ................................................................... 24, 52 W. Page Keeton et al., PROSSER AND KEETON ON TORTS (5th ed. 1984) .................................................. 51 INTRODUCTION This case is before the Court to decide two questions certified by the United States Court of Appeals for the Second Circuit. The first question concerns the duty of care owed to individuals who are subject to federally mandated drug tests and who are damaged by the dissemination of a false positive drug test report, or its equivalent. This second question concerns the doctrine of “third party reliance,” and this Court’s precedents allowing claims of fraud where a defendant deliberately induced a third party to rely on its false statement, injuring the plaintiff. Appellant Fred Pasternack is a licensed pilot and Senior Aviation Medical Examiner for the Federal Aviation Administration. In 2007, Pasternack was randomly selected for an FAA-mandated drug test. He appeared, cooperated with the test, and tested negative for any controlled substances. Nonetheless, the companies that collected his urine specimen and administered the test made a series of blunders and missteps along the way, causing the FAA to revoke Pasternack’s pilot certificates and examiner designation on the erroneous basis that he had refused to take his test. Specifically, in administering Pasternack’s drug test, Respondents violated federal drug testing regulations and rules and caused an erroneous report to be sent to the FAA. Later, one of those administrators intentionally deceived the FAA into thinking that Pasternack was at fault. 2 Pasternack fought the FAA to restore his licenses through two rounds of administrative proceedings, and after five years and two appeals, he ultimately prevailed in the D.C. Circuit and his licenses were restored. Pasternack filed this lawsuit in negligence and fraud to recover for the harms he suffered as a result of Respondents’ mismanagement of the random drug test that he dutifully took and passed. The district court dismissed Pasternack’s claims on the pleadings. It dismissed his negligence claim, holding that Respondents did not owe Pasternack a duty to act with reasonable care in administering his drug test, despite this Court’s ruling in Landon v. Kroll Laboratory Specialists, Inc., 22 N.Y.3d 1 (2013), which recognized that drug test laboratories owe their test subjects a common-law duty of care. It dismissed his fraud claim on the ground that New York law allows such claims only when a plaintiff relies on a defendant’s deceit, regardless of the injury that a plaintiff can suffer when the misrepresentation is directed to a third party. The Second Circuit has certified two questions to this Court. It first asks “whether drug testing regulations and guidelines promulgated by the FAA and DOT [Department of Transportation] create a duty of care for drug testing laboratories and program administrators under New York negligence law.” Pasternack submits that the proper question for this Court is, instead, whether the common-law duty of care that this Court recognized in Landon applies to FAA- 3 mandated drug tests and, if so, whether the FAA and DOT regulations and guidelines supply the relevant standards. The answer to those questions is yes. This Court recognized in Landon that an erroneous drug test report has a “profound, potentially life-altering, consequences for a test subject,” but that New York does not provide a statutory remedy for those injuries. To remedy this gap, this Court held that drug test administrators owe their test subjects a common-law duty of reasonable care and thus may be held liable in negligence when they fail to perform a drug test “in keeping with relevant professional standards.” Although Landon arose in the context of a probationer’s drug test, its holding applies equally to FAA-mandated drug tests. Erroneous reports of FAA- mandated tests unfairly label test subjects as drug users and cause severe harm, and there is no statutory remedy for the ensuing injuries. Thus, test administrators who conduct FAA-mandated tests owe their test subjects the same common-law duty of care that the Court recognized in Landon. In this setting, the FAA and DOT drug testing rules establish the relevant professional standards that Landon held drug test administrators must follow, and a test administrator’s violation of them is evidence of the administrator’s negligence. Alternatively, even if this Court chooses not to reformulate the first certified question, it should still find that FAA and DOT regulations and guidelines independently give rise to a duty of care that is actionable in negligence, given that 4 these rules were designed, in part, to protect test subjects from erroneous reports and the unfair stigmatization of being deemed a drug user. The Second Circuit next asks “whether a plaintiff may establish the reliance element of a fraud claim under New York law by showing that a third party relied on a defendant’s false statements resulting in injury to the plaintiff.” This Court has already resolved the Second Circuit’s fraud question in the affirmative. In a series of decisions that have guided lower and sister courts for over a century, this Court held that a plaintiff may bring a fraud claim under New York law if he was injured by a defendant’s intentional false statements, whether the plaintiff or a third party relied on those statements. This Court should reaffirm that rule of law both because it is settled precedent and because a defendant’s intentional deceit is equally wrongful and equally fraudulent when it is relied upon by the injured party as when it induces reliance by a third party. There is no reason to reverse this correct and settled New York law—particularly where, as here, the defendant should reasonably have anticipated that the plaintiff would be harmed by its knowing misrepresentations. JURISDICTIONAL STATEMENT This Court has jurisdiction pursuant to Section 500.27 of the Rules of Practice of the Court of Appeals of the State of New York. On December 15, 5 2015, this Court accepted the questions certified in the Second Circuit’s opinion dated November 17, 2015, as amended on November 23, 2015. QUESTIONS CERTIFIED FOR REVIEW “First, whether drug testing regulations and guidelines promulgated by the FAA and DOT create a duty of care for drug testing laboratories and program administrators under New York negligence law.” “Second, whether a plaintiff may establish the reliance element of a fraud claim under New York law by showing that a third party relied on a defendant’s false statements resulting in injury to the plaintiff.” As the Second Circuit acknowledged, this Court “is not limited to the particular questions stated. Rather, the Court of Appeals may modify the certified questions, and may direct the parties to address any other issues that may pertain to the circumstances presented in this appeal.” (A-315).1 This Court, moreover, on occasion has reformulated questions certified by the Second Circuit. See, e.g., Barenboim v. Starbucks Corp., 21 N.Y.3d 460, 470 (2013) (reformulating certified question at the suggestion of amicus curiae); Fuentes v. Bd. of Educ. of City of New York, 12 N.Y.3d 309, 314 (2009) (reformulating certified question on the Court’s own initiative). 1 “A-” refers to Pasternack’s Appendix filed herewith. “ADD-” refers to the Addendum attached to this brief. 6 For the reasons explained below, see infra at 21-26, the first question stated by the Second Circuit should be modified as follows: Whether the common-law duty of care that this Court recognized in Landon—that drug testing laboratories and program administrators owe each test subject a duty “to perform his drug test in keeping with relevant professional standards”—applies to FAA-mandated drug tests, and, if so, whether the FAA and DOT regulations and guidelines supply the relevant standards. STATEMENT OF FACTS A. The Parties Appellant Fred Pasternack is an accomplished physician and civilian pilot who served this country with honor for over three decades as a flight surgeon in both the United States Air Force and the Air National Guard. (A-166 ¶¶ 7-8). From 1978 until the events giving rise to this appeal, Pasternack served as a Senior Aviation Medical Examiner (“AME”) for the FAA, giving him the authority to conduct FAA-mandated medical examinations for pilots and prospective pilots. (A-166 ¶ 9). Pasternack has been a licensed pilot since 1965, and had flown commercial flights for a variety of aviation companies for decades. (A-167 ¶ 10). At the time of his drug test in 2007, Pasternack piloted airplanes for Northeastern Aviation Corporation (“Northeastern”) and an aerial advertising business. (Id.). The FAA regulated both of Pasternack’s activities—flying planes and acting as an 7 AME—and Pasternack held a number of FAA certificates and authorizations to engage in these activities. (A-166 - A-167 ¶¶ 9, 11). Northeastern hired Respondent ChoicePoint, Inc. (“ChoicePoint”) to administer Northeastern’s drug testing program. (A-168 ¶ 14). In addition to administering the program as a whole, ChoicePoint also served as a so-called “Medical Review Officer” (“MRO”) for Northeastern’s tests, pursuant to which it provided a range of medical related functions required by the FAA and DOT. (Id.). ChoicePoint, in turn, subcontracted with Respondent Laboratory Corporation of America (“LabCorp”) to collect and test the specimens. (Id. ¶ 15). B. The FAA’s Drug Testing Regime The Federal Omnibus Transportation Employee Testing Act of 1991 directed the FAA to establish a drug testing program for the aviation industry and to adopt regulations for such program “[i]n the interest of aviation safety.” 49 U.S.C. § 45102(a). The FAA has promulgated regulations requiring air carriers to subject their pilots and other specified categories of employees to random drug testing and to administer a drug testing program that complies with the drug testing regulations issued by the Department of Transportation (“DOT Regulations”). 14 C.F.R. §§ 120.103(b)(1), 120.105. Under the DOT Regulations, employers may use third-party “service agents” to perform many of the above regulated functions in their drug testing programs, 8 including collecting specimens from employees, testing specimens for the presence of drugs and serving as MROs2 who review the laboratory results and then issue a test report. 49 C.F.R. §§ 40.15(a), 40.343. The DOT Regulations are codified at 49 C.F.R. Part 40. They provide a comprehensive set of protocols and procedures that govern all DOT and FAA mandated drug testing programs. See 49 C.F.R. § 40.1(a). The DOT has also issued Urine Specimen Collection Guidelines (the “Guidelines”), which similarly govern the administering of drug tests under the FAA and DOT regimes. See 49 C.F.R. § 40.33(a); Guidelines at 3 (The Guidelines “must be followed whenever a DOT-required urine specimen collection is performed. . . . It is imperative that collectors fully understand and follow these procedures.”).3 The DOT Regulations and Guidelines govern all aspects of the drug testing process. The DOT Regulations mandate how employers interact with test personnel and their employees in connection with drug tests (see 49 C.F.R. §§ 40.11 - 40.29); how laboratories test specimens (see 49 C.F.R. §§ 40.81 - 40.113); how collectors collect and process specimens (see 49 C.F.R. §§ 40.31 - 40.73); how Medical Review Officers verify test results and investigate anomalies, and 2 MROs provide a range of medical related functions, including “medical review[s] of employees’ test results” and determining “whether there is a legitimate medical explanation for a confirmed positive, adulterated, substituted, and invalid drug test results from the laboratory.” 49 C.F.R. §§ 40.3, 40.123(b)-(d). 3 A complete set of the Guidelines in existence at the time of Pasternack’s drug test is included in the Addendum to this brief (ADD-1 - ADD-42). 9 when and how they may issue test reports (see 49 C.F.R. §§ 40.121 - 40.169); and how substance abuse professionals evaluate, refer, and treat employees (see 49 C.F.R. §§ 40.281 - 40.313). Many of these rules are designed to ensure the accuracy of the test reports and to protect test subjects from error throughout the testing process. For example, the rules require laboratories to verify that the identification numbers on specimen bottles match the numbers on the accompanying paperwork identifying the test subject. See 49 C.F.R. § 40.83(c)(1). The DOT Regulations specify the cutoff concentrations for each category of prohibited substance that laboratories must apply in performing their testing. See 49 C.F.R. § 40.87(a). There are also DOT Regulations and Guidelines designed to avoid contamination or other mishaps in the collection process that could improperly impact the test results. See, e.g., 49 C.F.R. § 40.43(d)(2) (“To the greatest extent you can, keep an employee’s collection container within view of both you and the employee between the time the employee has urinated and the specimen is sealed.”); Guidelines at 15 (same). Similarly, the DOT Regulations require the involvement of an MRO to verify any “confirmed positive, adulterated, substituted, or invalid drug tests [it] receive[s] from a laboratory.” 49 C.F.R. §§ 40.129(a), 40.131. The DOT Regulations also require the MRO to “act to investigate and correct problems where possible and notify appropriate parties (e.g., HHS, DOT, employers, service 10 agents) where assistance is needed, (e.g., cancelled or problematic tests, incorrect results, problems with blind specimens).” 49 C.F.R. § 40.123(e). Like the laboratory and collection protocols, the regulations directing the MRO process are designed both to protect test subjects from error and to ensure the accuracy of the test reports: the DOT implemented the MRO procedures as a “matter of fairness” to test subjects and to avoid the “unfair stigmatization of an employee as a drug user.” Procedures for Transportation Workplace Drug and Alcohol Testing Programs, 65 Fed. Reg. 79462-01, 79463, 79465 (Dec. 19, 2000). The DOT Regulations also direct the collectors to educate the test subjects about the process and to ensure that they are knowledgeable about the attendant consequences of their actions. For example, the collector must “[e]xplain the basic collection procedure to the employee” and “advise the employee that failure to comply with [the collector’s] directions constitutes a refusal to test.” 49 C.F.R. § 40.61(e)-(f); Guidelines at 11. See also 49 C.F.R. § 40.3 (defining the collector as, inter alia, the “person who instructs and assists employees at a collection site”). In addition to the aviation industry, the DOT Regulations and Guidelines govern drug testing of commercial motor vehicle drivers as well as individuals in the public transportation, railroad, merchant marine, nuclear energy, and pipeline industries. See 10 C.F.R. §§ 26.4(e)(6)(iv), 26.31(b)(2), 26.415(c); 46 C.F.R. § 16.113(a); 49 C.F.R. §§ 199.5, 219.701, 382.105, 655.51. 11 C. The Consequences Of A False Positive Test Result Or Wrongfully Being Deemed A Refusal To Test Testing positive for drugs has severe consequences for the test subject. See 14 C.F.R. § 67.107(b)(2) (holders of airman medical certificates may not have had a verified positive drug test result within the prior two years); 49 U.S.C. § 44709(b)(1)(A) (the FAA may revoke an airman’s certificate if “safety in air commerce or air transportation and the public interest require that action”). The consequences of being deemed a refusal to test are generally the same, or more severe, than testing positive for prohibited drugs. See 65 Fed. Reg. at 79500-01 (“For the most part, the consequences of a refusal are the same or more severe as for any other violation of DOT agency drug and alcohol regulations.”); Procedures for Transportation Workplace Drug and Alcohol Testing Programs, 64 Fed. Reg. 69076-01, 69081 (Dec. 9, 1999) (“[A] refusal is a violation of DOT agency regulations, with consequences similar to those of a positive test. . . . Under some DOT agency regulations . . . the consequences of a refusal to test can be more stringent than those of a positive test.”); see also 14 C.F.R. § 67.107(b)(2) (holders of airman medical certificates may not have refused to submit to a required drug test within the prior two years). There is no private right of action under the DOT or FAA regulatory regimes under which test subjects may obtain redress for errors in the testing process. Drake v. Delta Air Lines, Inc., 147 F.3d 169, 170-71 (2d Cir. 1998). Recognizing 12 that test subjects have other legal avenues of redress and to ensure those remain available to them, the DOT Regulations prohibit employers and their retained service agents from obtaining waivers of civil liability from their test subjects. 49 C.F.R. §§ 40.27, 40.355(a) (barring employers and service agents from requiring “an employee to sign a consent, release, waiver of liability, or indemnification agreement with respect to any part of the drug or alcohol testing process covered by this part (including, but not limited to, collections, laboratory testing, MRO, and [substance abuse professional] services).”). D. Defendants’ Faulty Administration Of Pasternack’s Drug Test 1. LabCorp Failed to Follow the “Shy Bladder” Procedures or to Tell Pasternack about the Consequences of Leaving the Facility. On June 1, 2007, Northeastern notified Pasternack that he had been randomly selected for a drug test. (A-168 ¶ 16). Pasternack reported to LabCorp’s collection site on June 5 at 1:10 pm with a pre-printed “chain-of-custody” form (“CCF”) provided to him by Northeastern, as the DOT Regulations require. (A- 168 - A-169 ¶¶ 16-17). Once there, Pasternack followed the instructions of LabCorp’s collector, Theresa Montalvo, and attempted to provide a urine specimen for his drug test. (A-169 ¶ 18). In what is commonly referred to as a “shy bladder” scenario, Pasternack was unable to produce a sufficient volume of urine. (Id.). Although Montalvo told Pasternack that he had not produced enough urine (id.), she ignored DOT procedures on how to handle the situation. 13 Specifically, when a test subject fails to produce a sufficient specimen, the collector must explain the so-called “shy bladder process” to the subject. Guidelines at 19-20. That is, Montalvo was required to “[u]rge [Pasternack] to drink up to 40 ounces of fluid, distributed reasonably through a period of up to three hours, or until the individual has provided a sufficient urine specimen, whichever occurs first.” 49 C.F.R. § 40.193(b)(2); Guidelines at 19. And she also needed to “specifically tell [Pasternack] that he [was] not permitted to leave the collection site and if [he did] so, that it will be considered a refusal to test.”4 Guidelines at 20. Ignoring these protocols, Montalvo merely directed Pasternack to return to the waiting area. (A-169 ¶ 20). Pasternack duly returned to the waiting area. (Id. ¶ 21). However, he was scheduled to examine a pilot that afternoon in his AME role and became concerned that he would not produce a sufficient specimen before that appointment. (Id.). As a result, Pasternack told Montalvo that he would need to leave and return later to complete the test. (A-170 ¶ 22). He and Montalvo discussed the details of his departure—whether he should take his CCF with him or leave it at the facility, and when he would return—and Montalvo concluded by telling him only that she 4 As the Second Circuit noted, the Guidelines were amended in 2014 to state that it is a best practice to inform the employee that such behavior could lead an employer to determine that a refusal occurred. (A-305). 14 would need to notify his employer of his departure. (Id.). She did not inform him that the test would immediately terminate, and she did not terminate the test. See Guidelines at 20 (requiring collector to terminate test and notify employer immediately if subject refuses to test by leaving the facility before the completion of the test). See also 49 C.F.R. § 40.191(d). Most importantly, she did not tell him that leaving could be deemed a “refusal to test,” information that the United States Court of Appeals for the District of Columbia Circuit (“D.C. Circuit”) recognized was “crucial.” Pasternack v. Nat’l Transp. Safety Bd., 596 F.3d 836, 839 (D.C. Cir. 2010); see Guidelines at 20. Based on this discussion, Pasternack left the collection site to attend to his AME appointment and with the intent to return to complete his test. (A-170 ¶ 25). He returned approximately three hours later and completed his test without incident and with Montalvo’s cooperation. (A-170 - A-171 ¶¶ 26-27). In fact, Montalvo explained that she would need to contact Northeastern before accepting a second specimen, and she then spoke to Northeastern, whose General Manager approved taking a second urine specimen. (Id. ¶ 26). Montalvo then obtained Pasternack’s specimen. (A-171 ¶ 27). Consistent with Pasternack’s understanding that his test was still open and valid, Montalvo used the same CCF to complete the collection that Pasternack brought with him earlier that day and that she had initiated before Pasternack left the facility. (A-171 ¶ 28). 15 This time, Pasternack produced a sufficient specimen for LabCorp to test, and his specimen tested negative for any prohibited drug. (A-171 ¶¶ 27, 29). LabCorp forwarded the negative test result to ChoicePoint, along with the completed CCF, on which Montalvo had noted Pasternack’s temporary departure and Northeastern’s approval of the second collection. (A-171 ¶¶ 26, 29). 2. ChoicePoint Erroneously and Unreasonably Reported a Failure to Test. As the MRO, ChoicePoint was obligated by regulation to report Pasternack’s negative test result. (A-124 ¶ 35). ChoicePoint, however, reported Pasternack to both the FAA and Northeastern as a “Refusal to Test.” (A-172 ¶¶ 30-31; A-125 ¶¶ 38, 40). That report was demonstrably wrong. An employee can be deemed a “Refusal to Test” for a variety of reasons, but the MRO’s duties vary greatly depending on the reason. In particular, an MRO may not report a refusal except where the employee adulterated or substituted his specimen. 49 C.F.R. § 40.355(i). In all other circumstances: [The MRO] must not make a determination that an employee has refused a drug or alcohol test. This is a non-delegable duty of the actual employer. You may, however, provide advice and information to employers regarding refusal-to-test issues. Id. (emphasis added). See also 49 C.F.R. § 40.151 (an MRO should not make factual determinations that do not depend on its medical knowledge and training); 65 Fed. Reg. at 79481 (DOT Regulations “ensure that the MRO, standing alone, 16 would not be called on to make a decision for which he or she lacked the needed expertise”). ChoicePoint also erred in reporting a refusal without conducting any investigation. (A-172 ¶ 30; A-124 ¶ 36); see 49 C.F.R. § 40.123(e) (MROs “must act to investigate and correct problems where possible” (emphasis added)). Finally, ChoicePoint omitted the relevant information in its report to the FAA and to Northeastern. (A-125 ¶ 38). It failed to disclose that it was reporting a refusal because Pasternack had left the facility (an incident it was not allowed to report on) as opposed to adulterating or substituting a specimen (incidents it could report on). (Id.). It failed to disclose that Montalvo had not terminated Pasternack’s test and had, instead allowed Pasternack to complete his test, as Northeastern had as well. (Id.). And it failed to disclose that Pasternack had actually tested negative. (Id.). E. The FAA’s Actions And Pasternack’s Successful Administrative Challenge Upon receiving ChoicePoint’s erroneous report, the FAA conducted a brief investigation. (A-172 ¶ 32). During that investigation, Montalvo falsely represented that Pasternack had been uncooperative during the collection and prevented her from explaining the shy bladder process and the consequences of his 17 leaving the facility. (A-172 - A-173 ¶¶ 33-35).5 Montalvo also concealed that Pasternack told her that he planned to return to complete his collection. (A-173 ¶ 35). On the basis of ChoicePoint’s false report, LabCorp’s false statements, and its own investigation, the FAA revoked Pasternack’s airman certificates and terminated his AME designation. (A-173 ¶ 36; A-126 ¶ 45). As a result, Pasternack was unable to pilot flights or perform AME duties and lost substantial income from his inactivity. (A-174 ¶ 39). Pasternack challenged the FAA’s actions through two rounds of administrative proceedings. (A-173 - A-174 ¶¶ 37-38). See Pasternack v. Huerta, 513 F. App’x 1 (D.C. Cir. 2013); Pasternack v. NTSB, 596 F.3d 836 (D.C. Cir. 2010). The administrative law judge (“ALJ”) found in favor of the FAA, and the National Transportation Board (“NTSB”) affirmed these findings, primarily on the basis of Montalvo’s false testimony that Pasternack “rushed” out of the facility before she could explain the DOT Regulations and Guidelines. (A-205). The D.C. Circuit reversed and remanded, holding that the ALJ did not properly assess Montalvo’s credibility, and rejecting the claim that Pasternack prevented her from telling him about the consequences of leaving the LabCorp 5 Among other misrepresentations, Montalvo stated that Pasternack was on his cell phone during the initial attempted collection. But Pasternack’s cell phone records establish that he did not use his phone during the collection. (A-172 - A-173 ¶ 33). 18 facility. Pasternack, 596 F.3d at 838-39. As the Court explained: even crediting Montalvo’s version of events, “it is utterly implausible that Montalvo had no opportunity to tell Pasternack that his leaving would be deemed a refusal” given that “it would have taken no more than a few seconds for Montalvo to convey that crucial piece of information,” and that Montalvo admitted that she and Pasternack spoke about his departure. Id. at 839. Although the Court remanded for “further proceedings consistent with [its] opinion,” id., the NTSB and ALJ charted a new course. The ALJ openly “note[d] [his] disagreement” with the D.C. Circuit, made findings of fact on issues not raised in the Court’s opinion, and again held that Pasternack had refused his test. (A-241-48). The NTSB again affirmed, and Pasternack again appealed. On March 22, 2013, just 11 days after oral argument, the D.C. Circuit vacated the administrative rulings a second time and entered judgment for Pasternack. Pasternack, 513 F. App’x at 2. The Court criticized the administrative rulings for ignoring that Montalvo never treated Pasternack as a refusal during the contemporaneous testing process, and noted that even the FAA conceded that “leaving with permission does not constitute a refusal” under the DOT Regulations. Id.6 And it held that “substantial evidence does not support the 6 See Babbitt v. Rojas, NTSB Order No. EA-5496, 2009 WL 5213712, at *5 (N.T.S.B. Dec. 30, 2009) (affirming reversal of the FAA revocation order where the collector had excused the subject from the test). See also Babbitt v. O’Doherty, Docket No. SE-18981, 2011 WL 1086073, 19 NTSB’s determination that [LabCorp] did not impliedly give Dr. Pasternack permission to leave” after his first collection attempt. Id. The FAA has since reinstated Pasternack airman’s certificates and AME designation and expunged his record of any reference to a drug test refusal. F. Procedural History On June 3, 2010, Pasternack sued Choice Point and LabCorp in the United States District Court for the Southern District of New York, asserting claims for negligence and fraud, among other claims. (A-14). Following motion practice, the district court dismissed Pasternack’s claims and proposed claims for negligence and fraud. (A-114, A-163, A-287). It ruled that negligence claims under New York law cannot be “premised solely” on an alleged violation of federal regulations or guidelines. (A-271). And it dismissed the fraud claim against LabCorp because the complaint alleged “that only the FAA—and not Pasternack— relied on LabCorp’s alleged misrepresentations.” (A-283). Pasternack appealed. In a written opinion dated November 17, 2015, and amended on November 23, 2015, the Second Circuit reserved decision and certified two questions of law to this Court. (A-314 - A-315). On December 15, 2015, this Court accepted the certified questions. (A-316). at *6 (N.T.S.B. Jan. 27, 2011) (reversing an FAA revocation order because the test administrator failed to inform the subject that leaving could be deemed a refusal and led him “to believe that he was excused”). 20 SUMMARY OF ARGUMENT Negligence – Under settled New York law, drug test administrators must perform their services with reasonable care. This Court expressly recognized this broad duty in Landon, where it held that a test subject can sue for negligence when a laboratory fails to perform its drug testing duties in accordance with the relevant professional standards. This is because, among other factors, false test reports can have devastating consequences for test subjects, the administrators are in the best position to prevent harm, and the subjects have no statutory remedy. Landon’s logic applies squarely to the FAA-mandated drug tests at issue here. Accordingly, drug testing laboratories and program administrators processing FAA-mandated drug tests owe the same duty of care to their subjects as do administrators who process non-FAA drug tests, and this duty arises from the common law, as recognized by Landon. In this setting, the FAA’s regulations and DOT Regulations and Guidelines supply the relevant standards and, under basic negligence principles, a drug test administrator’s violation of those standards is some evidence of the administrator’s negligence. Alternatively, those federal standards also give rise to their own independent duty of care. Fraud – This Court has already held that a plaintiff may state a claim for fraud when a defendant makes fraudulent misstatements or omissions to a third party whose reliance on them causes plaintiff harm. This Court should reaffirm 21 that rule of law here, under the principle of stare decisis; because the doctrine of third-party reliance is consistent with the principles of fair play that ground all fraud claims; and because, when a plaintiff is injured by a defendant’s deceit, there is no principled basis to artificially cabin fraud claims only to statements made directly to a plaintiff. ARGUMENT POINT I. THE FIRST CERTIFIED QUESTION SHOULD BE REFORMULATED The Second Circuit asked “whether drug testing regulations and guidelines promulgated by the FAA and DOT create a duty of care for drug testing laboratories and program administrators under New York negligence law,” a question it found to be case-dispositive. (A-311, A-314). The question as framed is problematic for two reasons. First, it wrongly assumes that any duty of care in the federal drug testing setting must arise solely out of the federal regulations and guidelines. That is incorrect, because the duty of care usually derives from the common law, and this Court has already recognized that drug testing laboratories owe their test subjects a duty of care grounded in the common law. Landon, 22 N.Y.3d at 6-7. Second, it misconstrues the interplay between common-law duties and federal regulations and guidelines. The federal regulations and guidelines are not the source of the duty of care, but merely supply a standard of care against which the defendants’ conduct may be measured. 22 A summary of general negligence law makes this clear. “To establish a cause of action sounding in negligence, a plaintiff must establish the existence of a duty on defendant’s part to plaintiff, breach of the duty and damages.” Greenberg, Trager & Herbst, LLP v. HSBC Bank USA, 17 N.Y.3d 565, 576 (2011). A duty of care typically derives from the common law. See, e.g., Tenuto v. Lederle Labs., Div. of Am. Cyanamid Co., 90 N.Y.2d 606, 612 (1997) (infant’s doctor owed a duty of care to the infant’s parents under “common-law principles of ordinary negligence and malpractice”). “Common-law experience teaches that duty is not something derived or discerned from an algebraic formula,” Palka v. Servicemaster Mgmt. Servs. Corp., 83 N.Y.2d 579, 585 (1994), and “the ‘policy-laden’ nature of the existence and scope of a duty generally precludes any bright-line rules.” Espinal v. Melville Snow Contractors, Inc., 98 N.Y.2d 136, 139 (2002). Instead, this Court “traditionally and as part of the common-law process fix[es] the duty point by balancing factors, including the reasonable expectations of parties and society generally, the proliferation of claims, the likelihood of unlimited or insurer-like liability, disproportionate risk and reparation allocation, and public policies affecting the expansion or limitation of new channels of liability.” Palka, 83 N.Y.2d at 586; see Tenuto, 90 N.Y.2d at 612 (“Courts resolve legal duty questions by resort to common concepts of morality, logic and consideration of the social 23 consequences of imposing the duty.”). See also Landon, 22 N.Y.3d at 6-7 (explaining the “strong policy-based considerations” for recognizing a drug tester’s duty of care to its test subjects).7 Once the duty is established, the next question is whether the defendant breached its duty of care. This is ordinarily a question for the fact-finder and has two components: (1) what conduct was required to comport with the duty of care under the circumstances (often referred to as the “standard of care”), and (2) whether the defendant’s conduct met that standard. See, e.g., Darby v. Compagnie Nat’l Air France, 96 N.Y.2d 343, 347 (2001) (“juries determine whether and to what extent a particular duty was breached”). When applicable, courts frequently look to statutes, regulations or industry guidelines to frame the standard of care—not to determine whether a duty exists in the first place. See Lorberblatt v. Gerst, 10 N.Y.2d 244, 248 (1961) (statute “does not create a new liability but merely changes or defines the standard of care which must be applied in an action to recover damages caused by lack of care” (emphasis added)). An unexcused violation of a statute constitutes negligence per se, meaning that it is conclusive proof that the defendant engaged in unreasonable conduct. Martin v. Herzog, 228 N.Y. 164, 168 (1920). 7 Whether the defendant owed the plaintiff a duty of care is a legal question for the courts. See Sanchez v. State of New York, 99 N.Y.2d 247, 252 (2002) (“The existence and scope of an alleged tortfeasor’s duty is, in the first instance, a legal question for determination by the courts.”). 24 Violations of administrative rules and regulations, municipal local ordinances and the like do not result in negligence per se, but inform what conduct is required to comport with the duty of care and provide “some evidence of negligence.” Elliott v. City of New York, 95 N.Y.2d 730, 733-34 (2001); see Bauer v. Female Acad. of Sacred Heart, 97 N.Y.2d 445, 454 (2002) (violation of a rule or regulation is “some evidence which the jury may consider on the question of defendant’s negligence, along with other evidence in the case which bears on that subject” (internal quotation marks omitted)). See generally RESTATEMENT (SECOND) OF TORTS § 286 (“the requirements of a legislative enactment or an administrative regulation” may be incorporated into the reasonable person standard).8 Industry guidelines, employee manuals and similar materials likewise inform the standard of care. See Trimarco v. Klein, 56 N.Y.2d 98, 107 (1982) (“professional and governmental bulletins” were probative of what conduct was reasonable under the circumstances); Nichter v. Hartley, 192 A.D.2d 842, 844 (3d Dep’t 1993) (school bus driver’s manual was “evidence (albeit nonconclusive) of the standard of care, akin to an institutional or industry-wide safety rule, that the triers of fact might find appropriate”). 8 Accordingly, evidence that the defendant’s conduct violated a regulation is sufficient to withstand a motion for summary judgment. See, e.g., Madry v. Heritage Holding Corp., 96 A.D.3d 1022, 1023-24 (2d Dep’t 2012); Scotto v. Marra, 23 A.D.3d 543, 544 (2d Dep’t 2005). 25 New York courts have, accordingly, looked to violations of federal regulations, including DOT Regulations, to inform the standard of care and to provide some evidence of negligence. See, e.g., Ferguson v. Hanson Aggregates New York, Inc., 103 A.D.3d 1174, 1175 (4th Dep’t 2013) (federal mine safety regulations relevant to whether mine owner breached common-law duty to employee to provide safe workplace); Landry v. Gen. Motors Corp., 210 A.D.2d 898, 898 (4th Dep’t 1994) (“[T]here is no reason that a violation of OSHA regulations, like other Federal or State regulations, should not be considered as some evidence of negligence under . . . the common law if the violation was a substantial factor in bringing about the occurrence.”); Cipriano v. State, 171 A.D.2d 169, 173 (3d Dep’t 1991) (defendant satisfied duty of care by complying with DOT guidelines); Siotkas v. LabOne, Inc., 594 F. Supp. 2d 259, 278-79 (E.D.N.Y. 2009) (issue of fact regarding whether defendant violated Department of Health and Human Services drug testing guidelines precluded granting summary judgment to plaintiff). See also Kindernay v. Hillsboro Area Hosp., 366 Ill. App. 3d 559, 571-72 (2006) (“The DOT regulations plainly establish the procedures to be followed by the defendant in administering the plaintiff’s drug test. No further evidence of the appropriate standard of care was necessary.”).9 9 See also, e.g., Ishikawa v. Delta Airlines, Inc., 343 F.3d 1129, 1132 (9th Cir. 2003) (holding that jury should consider federal drug testing guidelines in determining whether a laboratory complied with its common-law duty of care to the test subject); Spiker v. Sanjivan PLLC, No. 26 Accordingly, the appropriate question is not whether the federal regulations and guidelines supply a duty of care to the exclusion of the common law, but: “Whether the common-law duty of care that this Court recognized in Landon—that drug testing laboratories and program administrators owe each test subject a duty ‘to perform his drug test in keeping with relevant professional standards’—applies to FAA-mandated drug tests, and, if so, whether the FAA and DOT regulations and guidelines supply the relevant standards.”10 CV-13-00334-PHX-GMS, 2013 WL 5200209, at *14 (D. Ariz. Sept. 16, 2013) (“Although the DOT regulations do not set out the minimum standard of care and a violation of their requirements is not negligence per se, the regulations provide guidance as to the standard of reasonable care.”); Lacondeguy v. Adapa, No. 2:10-CV-1917-JAM-KJM, 2011 WL 9572, at *4 (E.D. Cal. Jan. 3, 2011) (granting plaintiff leave to amend to add allegation that MRO violated the DOT Regulations by falsely reporting a “positive” test result instead of a “refusal to test,” because such a violation can “serve as grounds to maintain the negligence claim against Defendant”); Miller v. Paris Cmty. Hosp., No. 07-CV-2195, 2009 WL 2050996, at *6 (C.D. Ill. July 13, 2009) (“Plaintiff can clearly rely on the DOT regulations to establish the procedures to be followed by PCH in administering his drug test, so that no further evidence of the appropriate standard of care is necessary.” (internal quotation marks and alterations omitted)); Balistrieri v. Express Drug Screening, LLC, No. 04-C-0989, 2008 WL 906236, at *14-16 (E.D. Wis. Mar. 31, 2008) (denying defendant’s motion for summary judgment insofar as plaintiff alleged that a collector of the opposite gender was present in the collection room with her supervisor, in violation of the DOT Regulations and Guidelines); Cutler v. Quality Terminal Servs., LLC, No. 08-cv-6630, 2009 WL 4674124, at *7 (N.D. Ill. Dec. 4, 2009) (under Illinois law, the violation of federal drug testing regulations are prima facie evidence that the defendant acted negligently if the defendant owes a common-law duty to the test subject); Kindernay, 366 Ill. App. 3d at 571- 72 (“The DOT regulations plainly establish the procedures to be followed by the defendant in administering the plaintiff’s drug test. No further evidence of the appropriate standard of care was necessary.”). 10 We assume that the Second Circuit’s identification of “drug testing laboratories and program administrators” is intended to include the activities that Choice Point and LabCorp performed in Pasternack’s drug test. LabCorp is a laboratory and ChoicePoint is a program administrator as those terms of art are used by the FAA. See 49 C.F.R. § 40.3 (“third-party administrator” “provides or coordinates the provision of a variety of drug and alcohol testing services to employers”); 49 C.F.R. §§ 40.81 - 40.113 (describing the role of laboratories). However, Pasternack challenges here LabCorp’s performance as a specimen collector and ChoicePoint’s 27 POINT II. UNDER LANDON, FAA DRUG TEST ADMINISTRATORS OWE A COMMON-LAW DUTY OF CARE TO THEIR TEST SUBJECTS, AND A VIOLATION OF THE APPLICABLE FEDERAL REGULATIONS AND GUIDELINES IS EVIDENCE THAT THE ADMINISTRATOR FAILED TO MEET THE REQUISITE STANDARD OF CARE A. Drug Test Administrators Owe Their Test Subjects A Common-Law Duty Of Care Under New York Law 1. This Court Recognized the General Duty of Care in Landon. In Landon, this Court held that drug test administrators owe their test subjects a duty of care under New York common law. Specifically, the Court held that a laboratory owes a broad “duty to the test subject to perform his drug test in keeping with relevant professional standards.” 22 N.Y.3d at 6-7. While serving a term of probation, the plaintiff, Eric Landon, was directed by his probation officer to submit to a drug test. His probation officer collected an oral sample and transmitted it to the defendant, Kroll Laboratory Specialists, Inc. (“Kroll”), for testing. Kroll determined that Landon tested positive for cannabinoids and reported that result to the probation department, which commenced proceedings to revoke Landon’s probation and have him incarcerated. Landon sued Kroll, contending that Kroll was negligent not only in how it tested his specimen but also in its failure to confirm the test results and in issuing an incomplete report. Specifically, Landon claimed that “the screen test cutoff level performance as the MRO who reported Pasternack as a “refusal” to the FAA. We use the term “drug test administrator” to refer to all roles in the drug testing process, including collector, laboratory, MRO and program administrator. 28 employed by Kroll was substantially lower than that recommended by [the company that manufactured the collection device] or by federal standards and that Kroll failed to disclose those differences in its report.” Id. at 4-5. Landon also claimed that New York State Department of Health Laboratory Standards “requir[e] samples to be subject to confirmatory testing through the use of gas chromatography-mass spectronomy, [but] Landon’s sample was not subject to any type of confirmation test before defendant reported a positive result.” Id. at 5. Finally, Landon claimed that Kroll negligently failed to disclose in its report that its testing of an oral fluid sample alone, rather than with a contemporaneous urine sample as proposed federal guidelines would require, heightened the potential for false positive readings. Id. This Court held that Kroll owed Landon a duty of reasonable care with respect to these alleged acts and omissions. Id. at 6-7. The Court identified five reasons why the laboratory should be held to such a duty: 1. A laboratory “‘launche[s] a force or instrument of harm’” against the test subject when it releases a false test report. Id. at 6 (quoting Espinal v. Melville Snow Contractors, Inc., 98 N.Y.2d 136, 140 (2002)). 2. The harm to a test subject is “not remote or attenuated. Indeed, it was [Landon’s] own biological specimen that was the sole subject of this testing and he was directly harmed by the positive test result . . . .” Id. 3. A false test report “will have profound, potentially life-altering, consequences for a test subject.” Id. 29 4. Those conducting drug tests are in the “best position” to prevent the release of damaging test results. Id. 5. There is “no apparent statutory remedy” for a victim of negligent drug testing. Id. at 7. The Court thus endorsed a broad duty that requires laboratories to exercise reasonable care in the testing process. Id.11 Landon is consistent with the rule in an overwhelming majority of states that drug and alcohol test administrators owe their test subjects a common-law duty of care in conducting drug tests. See, e.g., King v. Garfield County Pub. Hosp. Dist. No. 1, 17 F. Supp. 3d 1060, 1072-73 (E.D. Wash. 2014), rev’d on other grounds, 2015 WL 9459747 (9th Cir. Dec. 24, 2015); Rodriguez v. Lab. Corp. of Am. Holdings, 13 F. Supp. 3d 121, 131 (D.D.C. 2014); Warshaw v. Concentra Health Servs., 719 F. Supp. 2d 484, 505-06 (E.D. Pa. 2010); Garlick v. Quest Diagnostics, Inc., No. 06-cv-6244 (DMC), 2009 WL 5033949, at *3-9 (D.N.J. Dec. 14, 2009) (applying California, Indiana, Kansas, Oklahoma and Pennsylvania law); Quisenberry v. Compass Vision, Inc., 618 F. Supp. 2d 1223, 1228-31 (S.D. Cal. 2007); Baker v. Abo, No. Civ. 01-1248 JRTJSM, 2003 WL 21639151, at *2 n.7 (D. Minn. July 2, 2003); Williams v. Nat’l R.R. Passenger Corp., 16 F. Supp. 2d 178, 181-82 (D. Conn. 1998); Webster v. Psychemedics Corp., No. 2010-01087-COA- 11 Judge Pigott, in an opinion joined by Judge Read, argued that the majority “define[d] duty too broadly” because the duty that the majority recognized extended beyond cases involving “specific, narrow allegations of active negligence by the testing laboratory, such as mishandling, misidentifying or improperly collecting the specimen.” 22 N.Y.3d at 8, 10. 30 R3-CV, 2011 WL 2520157, at *6 (Tenn. Ct. App. June 24, 2011); Berry v. Nat’l Med. Servs., 205 P.3d 745, 749-50 (Kan. Ct. App. 2009); Sharpe v. St. Luke’s Hosp., 821 A.2d 1215, 1219-21 (Pa. 2003); Ragsdale v. Mount Sinai Med. Ctr. of Miami, 770 So. 2d 167, 169 (Fla. Dist. Ct. App. 2000); Duncan v. Afton, Inc., 991 P.2d 739, 744-46 (Wyo. 1999); Lynn v. Mount Sinai Med. Ctr., Inc., 692 So. 2d 1002, 1004 (Fla. Dist. Ct. App. 1997); Stinson v. Physicians Immediate Care, Ltd., 269 Ill. App. 3d 659, 662-65 (2d Dist. 1995); Elliott v. Lab. Specialists, Inc., 588 So. 2d 175, 176 (La. Ct. App. 1991); Lewis v. Aluminum Co. of Am., 588 So. 2d 167, 170 (La. Ct. App. 1991). See also Siotkas v. LabOne, Inc., 594 F. Supp. 2d 259, 274 (E.D.N.Y. 2009) (denying laboratory’s motion to dismiss negligence claim under New York law); Drake v. Lab. Corp. of Am. Holdings, No. 02-CV- 1924 (FB)(RML), 2007 WL 776818, at *2-3 (E.D.N.Y. Mar. 13, 2007) (negligence claim against LabCorp for violating FAA regulations adequately pled under New York law); Coleman v. Town of Hempstead, 30 F. Supp. 2d 356, 364-65 (E.D.N.Y. 1999) (denying LabCorp’s motion to dismiss a negligence action under New York law); Santiago v. Greyhound Lines, Inc., 956 F. Supp. 144, 152-53 (N.D.N.Y. 1997) (holding that a physician had a duty to collect a urine specimen with due care under New York law). The common-law duty of care is thus well established. 31 2. The Common-Law Duty of Care Applies Equally to All Drug Test Administrators, Regardless of the Mandate Under Which They Are Conducting the Tests. Landon, which arose in the probation context, applies equally to drug tests administered pursuant to the FAA and DOT Regulations, and to other drug tests as well. Indeed, a finding that this duty extends to some drug tests, but not others, would provide a remedy for certain drug testing subjects but not others, even when both victims are injured by the same wrongs and suffer similar harms. Drug testing companies like ChoicePoint and LabCorp administer and process a multitude of tests for a multitude of clients. On any given day, they may handle drug tests for private employers who require testing of employees for their own internal reasons; sports organizations; companies who are required to test their employees under FAA or DOT Regulations; or probationers like Landon. The tester’s liability should turn on its conduct, and not why the subject was being tested. Put differently, there is no moral, logical or societal reason to allow a probationer who receives a false positive drug report to recover for his tester’s negligence, but to bar a pilot or an Amtrak engineer from obtaining that same relief simply because the test was mandated by federal, and not state, law. Each of the “strong policy-based considerations that counsel[ed] in favor of finding that Kroll 32 owed a duty to [Landon]” is equally present in drug tests mandated by the FAA or DOT. This Court recognized as much in Landon, when it cited with approval a federal court decision holding that New York would recognize a common-law duty of care in connection with faulty drug tests conducted under the FAA. As this Court explained: The result we reach today is in keeping with that of several other jurisdictions to recognize a duty in similar circumstances (see e.g. Berry v National Med. Servs., 292 Kan 917, 257 P3d 287 [2011]; Sharpe v St. Luke’s Hosp., 573 Pa 90, 821 A2d 1215 [2003]; Duncan v Afton, Inc., 991 P2d 739 [Wyo 1999]), as well as that of certain federal courts concluding that New York would recognize such a duty (see e.g. Drake v Laboratory Corp. of Am. Holdings, 2007 WL 776818, *2, 2007 US Dist LEXIS 17430, *5 [ED NY, Mar. 13, 2007, No. 02-CV- 1924 (FB/RML)], affd 417 Fed Appx 84 [2d Cir 2011]; Coleman v Town of Hempstead, 30 F Supp 2d 356, 365 [ED NY 1999]). Landon, 22 N.Y.3d at 7. Drake also concerned a drug test taken by an FAA-regulated employee, and it held that New York would recognize a common-law duty of care on the part of drug test administrators who administered drug tests governed by the FAA and DOT Regulations. 2007 WL 776818, at *2-3. See also Spiker v. Sanjivan PLLC, No. CV-13-00334-PHX-GMS, 2013 WL 5200209, at *1, 9-10 (D. Ariz. Sept. 16, 2013) (negligence claims involving DOT testing of a truck driver); Siotkas, 594 F. 33 Supp. 2d at 274, 278-79 (negligence claims involving FAA testing of a pilot and a flight attendant); Phillips v. Quality Terminal Servs., LLC, No. 08-cv-6633, 2009 WL 4674051, at *4 (N.D. Ill. Dec. 4, 2009) (Federal Railroad Administration testing of railroad company employee); Balistrieri v. Express Drug Screening, LLC, No. 04-C-0989, 2008 WL 906236, at *13-16 (E.D. Wis. Mar. 31, 2008) (same); Chapman v. LabOne, 460 F. Supp. 2d 989, 1001 (S.D. Iowa 2006) (same). In Landon, this Court characterized Drake as “in keeping” with the Landon “result” of finding a duty of care of test administrators to their test subjects, and it recognized that the cases had properly concluded that New York would recognize “such a duty.” 22 N.Y.3d at 7. The other rulings which Landon cited as “recogniz[ing] a duty in similar circumstances” (Berry, Sharpe, Duncan and Coleman) concerned drug tests mandated by employers or as part of a licensing board’s employee assistance program. This Court thus recognized in Landon that the common-law duty of care applies across all types of drug tests, including those mandated by FAA and DOT rules. Landon’s policy-based factors lead to the same conclusion. First, drug test administrators who cause the issuance of a false drug report for a FAA or DOT-regulated drug test subject “launch” the very same “force or instrument of harm” that the test administrator did in Landon. See Landon, 22 N.Y.3d at 6. 34 Second, as in Landon, the harm to a test subject in an FAA- or DOT-ordered test is not “remote or attenuated.” See id. It will be the plaintiff’s “own biological specimen that [is] the sole subject of [a disputed FAA or DOT] testing” and it will be that plaintiff who will be “directly harmed” by a faulty report. Id. Drug test administrators conducting FAA- and DOT-mandated tests can reasonably foresee the negative consequences of their negligence, as they are required to be familiar with all of the DOT Regulations, including those addressing the consequences of a positive test result or a refusal to test. See, e.g., 49 C.F.R. §§ 40.33(a), 40.121(b)(3). ChoicePoint and LabCorp, for example, either did foresee, or should have foreseen, that their actions might lead the FAA to revoke Pasternack’s airman certificates. See Palka v. Servicemaster Mgmt. Servs. Corp., 83 N.Y.2d 579, 589 (1994) (defendant owed duty of care because conduct was “not directed to a faceless or unlimited universe of persons” but to “a known and identifiable group”); Palsgraf v. Long Island R.R. Co., 248 N.Y. 339, 344 (1928) (“The risk reasonably to be perceived defines the duty to be obeyed, and risk imports relation . . . .”). See also, e.g., Lewis, 588 So. 2d at 170 (laboratory owed duty of care because test subject “was not an unknown third party” and laboratory “was aware that negligent testing on its part could wrongfully identify him as a drug user . . . [and that his] employment opportunities would be compromised”). In other words, 35 the “possibilit[y] of danger” to a test subject like Pasternack is so “apparent as to entitle him to be protected.” Palsgraf, 248 N.Y. at 345. Third, a false report of a failed FAA or DOT drug test “will have profound, potentially life-altering, consequences for a test subject.” Landon, 22 N.Y.3d at 6. Whether it is incarceration as in Landon or the loss of livelihood here, the consequences of a faulty drug test are severe. As the Second Department recognized in Landon, an erroneous test report: may result in the loss of current employment, the forfeiture of retirement benefits and pension earned throughout the course of a lifetime of service, and the elimination of prospective employment opportunities. Moreover, a positive toxicology result may bear heavily on child custody decisions, or contribute to the complete termination of parental rights. Landon v. Kroll Lab. Specialists, Inc., 91 A.D.3d 79, 88 (2d Dep’t 2011) (collecting cases; internal citations omitted), aff’d, 22 N.Y.3d 1 (2013). Fourth, a test administrator is in the “best position” to prevent harm to his test subject regardless of whether he is administering a test for the FAA or county probation. See Hamilton v. Beretta U.S.A. Corp., 96 N.Y.2d 222, 233 (2001) (a “key” factor favoring recognition of a duty is “that the defendant’s relationship with either the tortfeasor or the plaintiff places the defendant in the best position to protect against the risk of harm”). This is especially true of ChoicePoint and LabCorp in this case. LabCorp, as the collector, “has a major role in the success of 36 the DOT’s drug testing program [because] . . . [t]he collector is the one individual in the testing process with whom all employees have direct, face-to-face contact.” Guidelines at 3. Accordingly, collectors are required to “instruct[] and assist[] employees at a collection site.” 49 C.F.R. § 40.3. ChoicePoint, as the MRO, was “an independent and impartial ‘gatekeeper’ and advocate for the accuracy and integrity of the drug testing process.” 49 C.F.R. § 40.123(a). It was to “provide[] a conclusive check by validating all drug test results that [it] receives from the laboratory” to “‘balance between safety interests and the protection of employees from unfair consequences of the process.’” Spiker, 2013 WL 5200209, at *12 (quoting Procedures for Transportation Workplace Drug and Alcohol Testing Programs, 65 Fed. Reg. 79462-01, 79464 (Dec. 19, 2000)). Fifth, as in Landon, there is no statutory remedy to address the breadth of the harm. See 22 N.Y.3d at 7. Under the administrative procedures of the Federal Aviation Act (“FAAct”), Pasternack was able to have his pilot’s license restored, but he could not obtain “any further redress, such as compensation for attendant harm.” Drake v. Lab. Corp. of Am. Holdings, 458 F.3d 48, 64 (2d Cir. 2006). And, as explained below, there is no private right of action under the FAAct. See infra at 44-45. Thus, absent a common-law cause of action, Pasternack cannot recover for his economic injuries, including lost income and the fees and costs he incurred pursuing his administrative remedies. 37 Accordingly, test administrators handling FAA- or DOT-mandated tests are not exempt from the broad common-law duty to perform their functions with reasonable care in keeping with relevant professional standards.12 B. The Drug Testing Regulations And Guidelines Promulgated By The FAA And DOT Inform The Standard Of Care Rather than providing the exclusive duty of care, the FAA and DOT Regulations and Guidelines help determine the applicable standard of care—“the care which the law’s reasonably prudent man should use under the circumstances of a particular case.” McLean v. Triboro Coach Corp., 302 N.Y. 49, 51 (1950). As this Court recognized in Landon, in a drug testing case the applicable standard of care is care that is “in keeping with relevant professional standards.” 22 N.Y.3d at 7. As set forth above, this Court has repeatedly looked to administrative rules and regulations, municipal local ordinances and the like, across a variety of 12 LabCorp also owed Pasternack a duty of care because it gave him a false sense of safety that “foreseeably led plaintiff to change his own conduct.” Heard v. City of New York, 82 N.Y.2d 66, 72-73 (1993); see Nallan v. Helmsley-Spear, Inc., 50 N.Y.2d 507, 522 (1980) (defendant owes duty if plaintiff “was lulled into a false sense of security and, as a consequence, neglected to take the precautions he might otherwise have taken”); Giglio v. Saratoga Care, Inc., 117 A.D.3d 1143, 1145 (3d Dep’t 2014) (security guard indicated to plaintiff that it was safe to walk); Kievman v. Philip, 84 A.D.3d 1031, 1033 (2d Dep’t 2011) (driver waved pedestrians across the road). See also McKinney v. Bellevue Hosp., 183 A.D.2d 563, 566 (1st Dep’t 1992) (failure to tell plaintiff that pre-employment physical had detected a serious medical condition negligently “induced reliance by plaintiff on his general good health and resulted in the failure to seek treatment”). LabCorp indicated to Pasternack that the only consequence of his temporarily leaving the collection site was that LabCorp would have to contact his employer. Had LabCorp informed him that he could also be deemed a refusal to test, Pasternack would not have left. (A- 170 ¶ 24). 38 settings, to inform the applicable standard of care, and courts in drug testing cases consistently look to the FAA and DOT’s Regulations and Guidelines to determine the “relevant professional standards.” See supra at 23-25.13 The only Appellate Division case in New York to apply Landon’s duty of care holding supports using the federal regulations and guidelines as the standard of care. In Braverman v. Bendiner & Schlesinger, Inc., 121 A.D.3d 353 (2d Dep’t 2014), the plaintiffs were under court supervision that required them to submit to random drug and alcohol testing. Id. at 355. A laboratory performed clinical testing on the plaintiffs’ oral fluid samples, which tested positive for drugs. Id. at 356. Those test results were forwarded to a drug treatment court, with negative consequences for the plaintiffs. Id. In their later negligence action against the laboratory, the plaintiffs claimed that the laboratory failed to place a label or disclaimer on its test reports “so as to indicate that the results were to be used for clinical purposes only,” as opposed to forensically. Id. at 356-57. The Second Department held that the plaintiffs’ claim was not actionable, in part, because it was not based on any cognizable standard. It explained that while 13 LabCorp has suggested that Pasternack cannot rely on a violation of the DOT Guidelines, because those guidelines cannot “be used to interpret the legal requirement[s] of the actual [Regulations].” Pasternack is not using the Guidelines to interpret the Regulations. The Guidelines—in addition to the Regulations—are relevant evidence of the standard of care and LabCorp’s negligence. According to the DOT itself, “It is imperative that collectors fully understand and follow [the Guidelines]. The[] guidelines, together with [the DOT Regulations] and the DOT operating administrations’ rules, will provide collectors with the information needed in the performance of their collection duties.” Guidelines at 3 (emphasis added). 39 Landon recognized a duty “to perform [a] drug test in keeping with relevant professional standards,” “there [we]re no professional standards implicated in [Braverman]” and the plaintiffs’ contention that a disclaimer or label was needed was “unsupported by reference to statutory, regulatory, or professional standards.” Id. at 359. Here, by contrast, there are clear regulatory and professional standards, namely, the FAA and DOT Regulations and Guidelines, such that a violation of them is evidence of negligence. It is appropriate, moreover, to look to these regulations and guidelines to provide the appropriate standard of care given that the purpose of negligence law is to ensure that individuals act reasonably to avoid harming others. The FAA adopted the DOT Regulations, at least in part, to protect test subjects like Pasternack from harm. See Omnibus Transportation Employee Testing Act of 1991 (“OTETA”), Pub. L. No. 102–143, § 2(6), 105 Stat. 953 (1991) (directing the FAA to regulate a drug test program with “adequate safeguards . . . [to] ensure[] that no individual’s reputation or career development is unduly threatened or harmed”); see Anti-Drug Program for Personnel Engaged in Specified Aviation Activities, 53 Fed. Reg. 47024-01, 47043 (Nov. 21, 1988) (“The FAA believes that the review and evaluation functions of an MRO provide critical and necessary safeguards for an employee who is subject to drug testing under the comprehensive anti-drug program.”). The DOT designed its procedures with the same purpose. 40 See Procedures for Transportation Workplace Drug Testing Programs, 54 Fed. Reg. 49854-01, 49856 (Dec. 1. 1989) (DOT drug testing procedures designed with a view toward “the very real career impact of even a temporary identification of someone as a drug user and . . . the lost job opportunities of applicants”). See also Spiker, 2013 WL 5200209, at *12 (“[T]he MRO review process is in part for the benefit for the employee.”). For example, according to the DOT, “individuals can be unfairly identified as drug users” “if an MRO . . . disregards DOT rules and guidance for making verification decisions.” Procedures for Transportation Workplace Drug and Alcohol Testing Programs, 64 Fed. Reg. 69076-01, 69086 (Dec. 9, 1999). And the DOT confirmed that “[e]ach of the requirements of [the DOT Regulations] is important to ensure the accuracy, integrity, privacy and fairness of the testing process as well as the safety of the public. If a service agent fails or refuses to meet these requirements, then these important interests are adversely affected.” 65 Fed. Reg. at 79467.14 For each of these reasons, the FAA and DOT drug testing Regulations and Guidelines supply the “professional standards” in the drug testing arena and a defendant’s violation of those standards is evidence of negligence. 14 The FAA’s and DOT’s purposes are self-evident in the particular provisions at issue in Pasternack’s case. These Regulations and Guidelines require collectors to guide test subjects so that they do not unwittingly refuse a test, and prevent MROs from making critical determinations about test subjects that are beyond MROs’ medical expertise. 41 C. The DOT Regulations And Guidelines May Also Independently Give Rise To A Duty Of Care In the alternative, in the event that the Court determines not to reformulate the first certified question, the same duty—that administrators of FAA-mandated drug tests owe their test subjects a broad duty of care—emanates from the FAA and DOT Regulations and Guidelines themselves. Although a drug test administrator’s duty of care is rooted in the common law, as this Court recognized in Landon, some courts have also recognized negligence duties springing directly from statutes, regulations and ordinances. See Lopes v. Rostad, 45 N.Y.2d 617, 623 (1978) (in negligence action, discussing a duty that had its source both in common law and statute); McSweeney v. Rogan, 209 A.D.2d 386, 387 (2d Dep’t 1994) (town ordinance gave rise to duty even when common law did not); Goodyear Tire & Rubber Co. v. Kirk’s Tire & Auto Servicecenter of Haverstraw, Inc., No. 02 Civ. 0504 (RCC), 2005 WL 550940, at *3 (S.D.N.Y. Mar. 9, 2005) (federal and state regulations gave rise to duty for purposes of negligence claim). Under these cases, when a statute was enacted “to protect only a limited class of individuals,” the plaintiff must be “within the protective orbit of the statute” to maintain a negligence action based on the violation of the statutory duty. Lopes, 45 N.Y.2d at 623 (internal quotation marks omitted). 42 As discussed supra at 9-10 and 39-40, the purposes of the FAA and DOT Regulations and Guidelines include, in part, protecting test subjects from the serious harms that flow from improperly performed tests. The DOT Regulations and Guidelines fulfill Congress’ directive to the FAA to regulate a drug test program with “adequate safeguards . . . [to] ensure[] that no individual’s reputation or career development is unduly threatened or harmed.” OTETA, Pub. L. No. 102–143, § 2(6), 105 Stat. 953 (1991). The DOT specifically designed its drug testing procedures with an eye toward “the very real career impact of even a temporary identification of someone as a drug user and . . . the lost job opportunities of applicants.” 54 Fed. Reg. at 49856. It discerned, for instance, that detailed MRO review protocols were needed as a “matter of fairness” to test subjects and to avoid the “unfair stigmatization of an employee as a drug user.” 65 Fed. Reg. at 79463, 79465. In fact, “[e]ach of the requirements of [the DOT Regulations] is important to ensure the accuracy, integrity, privacy and fairness of the testing process as well as the safety of the public.” Id. at 79467. Further, the FAAct has a so-called “savings clause” that unequivocally preserves “any other remedies provided by law” along with the very limited remedies under the FAAct, 49 U.S.C. § 40120(c), and states that “it does not intend for the Act to leave injured parties without remedy.” Drake, 458 F.3d at 64 (emphasis in original). By that clause, Congress “express[ly] invit[ed]” states to 43 “provide remedies for violations of FAA regulations” in order to “fill the gaps in [Congress’] deliberately incomplete remedial scheme.” Id. And to ensure access to these state remedies, the DOT Regulations bar employers and test administrators from requiring employees to waiver their civil claims. 49 C.F.R. §§ 40.27, 40.355(a). Those regulations “clearly anticipate that some tort claims arising from regulated drug testing will be viable.” Drake, 458 F.3d at 61. Allowing negligence claims based on “duties established by the federal [drug testing] regulations” thus furthers the aims of the drug testing regulatory regime. See id. at 63-64. As a result, should this Court answer the certified question as formulated by the Second Circuit, it should find that the FAA and DOT drug testing Regulations and Guidelines give rise to an independent duty of care that FAA drug test administrators owe to their test subjects. D. It Is Irrelevant That There Is No Private Right Of Action Under The FAAct In the federal court proceedings, LabCorp and ChoicePoint argued that Pasternack cannot rely on the DOT Regulations and Guidelines because they do not permit a private right of action. (See A-310). That argument is a non-sequitur because Pasternack is not asserting a private right of action under the DOT Regulations and Guidelines. See Ishikawa v. Delta Airlines, Inc., 343 F.3d 1129, 1132 (9th Cir. 2003) (describing the private-right-of-action argument as a “red 44 herring” when the plaintiff brings a state-law negligence action instead of a claim under the federal drug testing regulations). Rather, his claims are under New York State negligence law. This Court’s decision in Uhr v. E. Greenbush Cent. Sch. Dist., 94 N.Y.2d 32 (1999), is instructive. There, the plaintiff sued the school district and its board of education under New York State’s Education Law and for common-law negligence after sustaining injuries as a result of the district’s failure to conduct mandatory scoliosis testing. Id. at 36-37. The Court dismissed the Education Law claim, finding that there was no private right of action for a violation of that state statute. Id. at 42. The Court then separately analyzed the plaintiff’s negligence claim, specifically whether the school district owed the plaintiff a duty under New York common law. Although the Court held that the defendants did not owe the plaintiff a duty, it was not because of the lack of a private right of action under the Education Law. Rather, it was because of special rules regarding the municipal actors. Id. (citing Cuffy v. City of New York, 69 N.Y.2d 255, 260 (1987) (municipalities not subject to tort liability absent a “‘special relationship’ between the municipality and the claimant”)). The federal courts are in accord. In Drake, for example, the Second Circuit held that drug testing subjects may bring negligence claims under New York law for violations of the FAA and DOT drug testing rules, even though there is no 45 private right of action for a violation of the FAA regulations. Drake, 458 F.3d at 64. In fact, the lack of a private right of action supported allowing the negligence claims to proceed. See id. (“It is difficult to believe that Congress would, without comment, remove all means of judicial recourse for those injured by illegal conduct.” (quoting Silkwood v. Kerr-McGee Corp., 464 U.S. 238, 251 (1984))). Finally, the DOT Regulations that bar employers and test administrators from requiring employees to waive their civil claims, 49 C.F.R. §§ 40.27, 40.355(a), further “suggest[] that negligence claims may be brought.” Drake, 458 F.3d at 61. Cf. Ishikawa, 343 F.3d at 1133 (“[I]t would make no sense for the regulation to prohibit requiring the employee to waive negligence claims if those claims were preempted and could not be made.”); Spiker, 2013 WL 5200209, at *11 (holding that public policy, as reflected in sections 40.27 and 40.355(a), “supports holding a collector accountable [in negligence] to the individuals whose specimens it [collects]” (internal quotation marks omitted)). POINT III. THIS COURT SHOULD REAFFIRM THAT FRAUD DOES NOT DEPEND ON WHETHER THE PLAINTIFF HIMSELF RELIED ON THE DEFENDANT’S MISREPRESENTATION AS LONG AS THE PLAINTIFF WAS HARMED BY THE DEFENDANT’S DELIBERATE DECEIT New York abhors fraud in any form. For well over a century, this Court has held that a plaintiff can establish a fraud claim when a defendant makes a deliberate misrepresentation that causes a plaintiff harm, whether the 46 misrepresentation was relied upon by the plaintiff or a third party. That rule is consistent with the long-standing principle that fraud and falsehoods are wrongful in the eye of law. The Court should reaffirm that rule of law. A. Third-Party Reliance Is The Law In New York This Court first embraced the “third-party reliance” rule in decisions from the late 1800s, such as Rice v. Manley, 66 N.Y. 82 (1876), and Piper v. Hoard, 107 N.Y. 73 (1887). In Rice, the plaintiff agreed to buy “a large quantity of cheese” from the seller, and the defendant—pretending to be the plaintiff—sent a telegraph to the seller falsely saying that the plaintiff no longer wanted to buy the cheese. 66 N.Y. at 83-84. The seller relied on that deceitful communication and sold its cheese to the defendant, and the plaintiff lost the transaction and his expected profits. Id. at 84-85. The Court held that the plaintiff had stated a valid cause of action for fraud even though the false statement was not made to him and he did not rely on it; in fact, the plaintiff could not have reasonably relied on the statement because he would have known that it was false. The Court held: “[I]t matters not whether the false representations be made to the party injured or to a third party, whose conduct is thus influenced to produce the injury, or whether it be direct or indirect in its consequences. Schemes of fraud may be so cunningly devised as to elude the eye of justice, but they must not escape condemnation and reparation when discovered.” Id. at 87 (emphasis added). As the Court stated, 47 “[i]n order to maintain an action for fraud, it is sufficient to show that the defendant knowingly uttered a falsehood with the design to” harm the plaintiff. Id. at 84. Similarly, in Piper, the defendant had purchased land from a landowner who needed to have an heir at death to validate the sale. Id. at 75-76. The defendant induced the plaintiff’s mother to marry the landowner (and to bear the landowner’s child), by falsely promising that the land would transfer to any child born to the couple. Id. at 75-76. After the plaintiff was born, the defendant kept the land for himself. The plaintiff sued, claiming that the defendant had made false statements to plaintiff’s mother, on which the mother had relied, and which resulted in plaintiff being “the very person injured by the fraud.” Id. at 79. This Court held that these allegations stated a claim for fraud even though the plaintiff himself did not rely on the defendant’s misrepresentation. Id. Numerous Appellate Division courts have followed this rule and have recognized that a fraud claim is viable “where a false representation is made to a third party, resulting in injury to the plaintiff.” Ruffing v. Union Carbide Corp., 308 A.D.2d 526, 528 (2d Dep’t 2003); see also Buxton Mfg. Co. v. Valiant Moving & Storage, Inc., 239 A.D.2d 452, 454 (2d Dep’t 1997); Desser v. Schatz, 182 A.D.2d 478, 479-80 (1st Dep’t 1992); Cooper v. Weissblatt, 277 N.Y.S. 709, 714 (2d Dep’t 1935). These courts have had no trouble finding a fraud claim based on 48 third-party reliance because where “[r]eliance” by a third party and “clear detriment [to] plaintiff” is “manifest,” it is “of no moment . . . that the false representation was not made directly to plaintiff.” Desser, 182 A.D.2d at 479-80. “It is sufficient if the initial fraud intended to injure the plaintiff caused him damage through intermediate agencies thereby set in motion.” Cooper, 277 N.Y.S. at 714.15 The same is true for the many federal district courts that have applied the controlling precedents of this Court.16 Rice and Piper represent the law of this Court and should be reaffirmed under the doctrine of stare decisis—‘“the doctrine which holds that common-law decisions should stand as precedents for guidance in cases arising in the future’ and 15 Although some Appellate Division cases have rejected fraud claims that were not premised on the plaintiff’s own reliance, see, e.g., Aymes v. Gateway Demolition Inc., 30 A.D.3d 196, 197 (1st Dep’t 2006); Briarpatch Ltd., L.P. v. Frankfurt Garbus Klein & Selz, P.C., 13 A.D.3d 296, 297 (1st Dep’t 2004); Garelick v. Carmel, 141 A.D.2d 501, 502 (2d Dep’t 1988), most of those decisions “do not relate to the third-party reliance doctrine, and make no mention of the Eaton line of cases.” Prestige Builder & Mgmt. LLC v. Safeco Ins. Co. of Am., 896 F. Supp. 2d 198, 204 (E.D.N.Y. 2012). 16 See Good Luck Prod. Co. v. Crystal Cove Seafood Corp., 60 F. Supp. 3d 365, 376 (E.D.N.Y. 2014); My First Shades v. Baby Blanket Suncare, 914 F. Supp. 2d 339, 352 (E.D.N.Y. 2012); Prestige Builder, 896 F. Supp. 2d at 203; Chevron Corp. v. Donziger, 871 F. Supp. 2d 229, 257 (S.D.N.Y. 2012); Liberty Life Assur. Co. of Boston v. Bahan, No. 09 Civ. 4715 (JSR), 2010 WL 3431147, at *2 (S.D.N.Y. Aug. 23, 2010); O’Brien v. Argo Partners, Inc., 736 F. Supp. 2d 528, 537 (E.D.N.Y. 2010); In re Pharm. Indus. Average Wholesale Price Litig., MDL No. 1456, No. 01-12257-PBS, 2007 WL 1051642, at *13 (D. Mass. Apr. 2, 2007); N.B. Garments (PVT), Ltd. v. Kids Int’l Corp., No. 03 Civ. 8041(HB), 2004 WL 444555, at *3 (S.D.N.Y. Mar. 10, 2004; Union Carbide Corp. v. Montell N.V., 9 F. Supp. 2d 405, 411 (S.D.N.Y. 1998). The Second Circuit previously ruled to the contrary in Cement & Concrete Workers Dist. Council Welfare Fund v. Lollo, 148 F.3d 194, 196 (2d Cir. 1998), and City of New York v. Smokes-Spirits.com, Inc., 541 F.3d 425, 454 (2d Cir. 2008), rev’d and remanded sub nom. Hemi Grp., LLC v. City of New York, N.Y., 559 U.S. 1 (2010), and certain district courts have followed those rulings. However, those Second Circuit cases failed to acknowledge this Court’s precedents and the panel that certified this question to this Court did not wish to rely upon them. (See A-312 - A-314). 49 that a rule of law ‘once decided by a court, will generally be followed in subsequent cases presenting the same legal problem.’” State Farm Mut. Auto. Ins. Co. v. Fitzgerald, 25 N.Y.3d 799, 819 (2015) (internal quotation marks omitted); see id. (even if the current Court disagrees with its holding in a prior decision, the Court “would nonetheless be bound to follow it under the doctrine of stare decisis”). “Stare decisis is ‘the preferred course because it promotes the evenhanded, predictable, and consistent development of legal principles, fosters reliance on judicial decisions, and contributes to the actual and perceived integrity of the judicial process.’” State v. Donald DD., 24 N.Y.3d 174, 187 (2014) (quoting Payne v. Tennessee, 501 U.S. 808, 827 (1991)). B. There Is No Principled Basis To Limit Fraud Claims To Those In Which The Defendant’s Deceit Caused The Plaintiff To Be Injured By His Own Reliance, And Not By The Reliance Of A Third Party The rule of third-party reliance should also be reaffirmed because it is sound. 1. “Fraud” Embraces Circumstances in Which the Plaintiff Was the Foreseeable Victim of a Deceit Practiced on a Third Party. It Is a Wrong That Demands a Remedy. The “essence of fraud” is an intentional deceit to induce reliance for personal gain. People v. Mancuso, 255 N.Y. 463, 484 (1931). Accordingly, “fraud” encompasses a wide range of circumstances bearing the hallmark of such deceit: Certainly the word “fraud” or “fraudulent” has not “a technical or other special meaning.” Conduct may be 50 fraudulent or otherwise accordingly as we apply the standards of law or morality, of civil or criminal law, of the common law or of equity. Thus, fraud is said to be “any cunning, deception or artifice, used to circumvent, cheat or defraud another”; “all surprise, trick, cunning, dissembling, and other unfair way that is used to cheat any one”; “a device by means of which one party has taken an unconscientious advantage of the other”. It has been said that, “It is impossible to separate deceit or artifice from fraud; it is of the very essence of the fraud.” Id. (internal citations omitted). Notably, “[t]he mere forms adopted for the perpetration of frauds are of little importance.” Rice, 66 N.Y. at 87. It matters not whether the defendant practices its deceit upon the plaintiff himself or on some other party, as long as the deceit is intentional, is made for the defendant’s personal gain, and has the plaintiff as its foreseeable victim. Simply stated, “there is no general common-law principle holding that a fraudulent misrepresentation can cause legal injury only to those who rely on it.” Bridge v. Phoenix Bond & Indem. Co., 553 U.S. 639, 656 (2008). Rather, “a fraudulent misrepresentation can proximately cause actionable injury even to those who do not rely on the misrepresentation.” Id. at 656 n.7 (citing Rice); see also id. at 656 n.6 (“Of course, a misrepresentation can cause harm only if a recipient of the misrepresentation relies on it. But that does not mean that the only injuries proximately caused by the misrepresentation are those suffered by the recipient.”). 51 Reaffirming the principle of third-party reliance is consistent with the principles of justice that gave rise to the cause of action for fraud more than 200 years ago. “[T]hat a man may assert that which he knows to be false, and thereby do an everlasting injury to his neighbor, and yet not be answerable for it . . . is as repugnant to law as it is to morality.” Pasley v. Freeman 100 Eng. Rep. 450 (K.B. 1789) 455; 3 T.R. 51, 6.17 Indeed, the law of fraud is “founded in common sense or common honesty”—principles that are as applicable “to any case which may arise two centuries hence as it was two centuries ago.” Pasley, 100 Eng. Rep. at 456, 3 T.R. at 62-63. “Fraud and falsehood are mala in se, and wrongful in the eye of the law.” Rice, 66 N.Y. at 84. A defendant’s intentional deceit is equally wrongful when it is directed to the injured party as when it induces reliance by a third party. Accordingly, there is no legitimate reason to provide a fraud cause of action only for the former pattern, and not the latter. To do so would contravene “[t]he unquestioned principle of jurisprudence from very early times that there can be no wrong without a remedy.” Rozell v. Rozell, 281 N.Y. 106, 112 (1939) (internal citation and quotation marks omitted). Thus, where the core principles underlying fraud claims—intentional deception that causes damage—are present, it should not matter who relied on the 17 “Pasley v. Freeman . . . is the parent of the modern law of deceit . . . .” W. Page Keeton et al., PROSSER AND KEETON ON TORTS § 105 at 728 (5th ed. 1984). Pasley is cited with approval in Rice, 66 N.Y. at 86. 52 defendants’ wrong. What matters is that the defendant lied, someone believed him, and it caused the plaintiff to suffer in foreseeable ways. To rule otherwise just rewards the wrongdoer. 2. The Tort of Tortious Interference with Business Relations Does Not Displace Recovery in Fraud. The district court in this case held that fraud claims should exclude the third- party reliance species of deceit because the separate tort of tortious interference with business relations can provide a remedy. (A-281-82). This argument fails for at least three reasons. First, it is hornbook law that the same conduct can support separate and independent tort causes of action. See Mayle v. Felix, 545 U.S. 644, 669 (2005) (“[T]he same conduct, transaction, or occurrence can support multiple, discrete claims for relief.”). Thus, tortious interference and fraud are not mutually exclusive. See RESTATEMENT (SECOND) OF TORTS § 767 comment c (“[O]ne who is liable to another for intentional interference with economic relations by inducing a third person by fraudulent misrepresentation not to do business with the other may also be liable under other rules of the law of torts.”). Second, the district court’s analysis, if adopted, would deprive plaintiffs of the extended limitations period applicable to fraud. Because a claim for fraud is difficult to uncover, it may be commenced within “the greater of six years from the date the cause of action accrued or two years from the time the plaintiff or the 53 person under whom the plaintiff claims discovered the fraud, or could with reasonable diligence have discovered it.” C.P.L.R. 213(8) (emphasis added). See Zumpano v. Quinn, 6 N.Y.3d 666, 681-82 (2006). A claim of tortious interference with business relations, on the other hand, must be brought within three years, and it begins to run as soon as “the defendant performs the action (or inaction) that constitutes the alleged interference.” Thome v. Alexander & Louisa Calder Found., 70 A.D.3d 88, 108 (1st Dep’t 2009); see C.P.L.R. 214(4) (three-year statute of limitations for any “action to recover damages for an injury to property”). Limiting plaintiffs to a tortious interference claim in this circumstance would thwart the legislative policy underlying the extended limitations period for fraud. Third, not every case that raises issues of third-party reliance involves an actual or prospective business relationship between the third party and the defendant, as necessary to sustain a cause of action under tortious interference with business relations. See Carvel Corp. v. Noonan, 3 N.Y.3d 182, 192 (2004) (“[C]onduct constituting tortious interference with business relations is, by definition, conduct directed . . . at the party with which the plaintiff has or seeks to have a relationship.”). Indeed, many of the cases in which courts have allowed a fraud claim based on third-party reliance involved facts which could not be restated as a claim for tortious interference with business relations. 54 In Cooper, for example, the defendants made false statements to a rabbinical tribunal, which relied on those false statements in issuing a ruling adverse to the plaintiff. 277 N.Y.S. at 711-12. The Second Department held that the plaintiff had a fraud claim against the defendants, even though he did not rely on any misrepresentations they made, because of “the willful and intentional deceit practiced by defendants upon the innocent members of the Din Torah, in inducing their signatures to a fictitious decision.” Id. at 716. Plaintiff could not have brought a tortious interference claim because it was merely a party to proceedings before the tribunal, and did not have actual or prospective business relations with the rabbis. See also, e.g., Good Luck Prod. Co., 60 F. Supp. 3d 365 (plaintiff had no business relationship with party who relied on misstatement); Prestige Builder & Mgmt., 896 F. Supp. 2d 198 (same); Chevron, 871 F. Supp. 2d at 254 (same); Pharm. Indus. Average Wholesale Price Litig., 2007 WL 1051642 (same); N.B. Garments, 2004 WL 444555 (same); Union Carbide, 9 F. Supp. 2d 405 (same); Piper, 107 N.Y. 73 (same); Ruffing, 308 A.D.2d 526 (same); Buxton, 239 A.D.2d at 453 (same); Desser, 182 A.D.2d at 479 (same). 3. Allowing Fraud Claims Based On “Third-Party Reliance” Does Not Unreasonably Expand Liability. This Court would not unreasonably expand a defendant’s potential liability by reaffirming the long standing rule of third-party reliance, so long as the class of plaintiffs is appropriately limited to those that the defendant could foresee would 55 be injured by its deceit. See Pharm. Indus. Average Wholesale Price Litig., 2007 WL 1051642, at *13 (“Third party reliance on fraud is . . . cognizable under New York law where there is a sufficient causal connection between a defendant’s fraud and a plaintiff’s injury.”). Confining the third-party reliance doctrine to circumstances like those in Rice and Piper, in which the plaintiff is a known or foreseeable victim of the defendant’s fraud at the time the defendant made its misrepresentation or omission, will avoid any potential risk “of far-flung liability for inchoate or unintended injuries,” and thus appropriately limits the cause of action. Union Carbide, 9 F. Supp. 2d at 412. This rule has well-served New York for over 100 years; it has not opened the floodgates for litigation, and there is no reason to change it now. 56 CONCLUSION For the foregoing reasons, this Court should modify the first certified question and answer both questions in the affirmative. Dated: New York, New York February 12, 2016 Cynthia S. Arato Daniel J. O’Neill SHAPIRO ARATO LLP 500 Fifth Avenue, 40th Floor New York, New York 10110 (212) 257-4880 Attorneys for Plaintiff-Appellant Fred L. Pasternack /s/ Cynthia S. Arato ADDENDUM TABLE OF CONTENTS PAGE Department of Transportation, Urine Specimen Collection Guidelines, revised December 2006 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ADD-1 Urine Specimen Collection Guidelines United States Department of Transportation Office of Drug and Alcohol Policy and Compliance Revised December 2006 ADD-1 DOT Urine Specimen Collection Guidelines 2 DOT Urine Specimen Collection Guidelines for the U.S. Department of Transportation Workplace Drug Testing Programs (49 CFR Part 40) These guidelines apply only to employers and individuals who come under the regulatory authority of the U.S. Department of Transportation (DOT) and those individuals who conduct urine specimen collections under DOT regulations. The term “employee” is used throughout this document and has the same meaning as “donor” as used on the Federal Drug Testing Custody and Control Form (CCF). These guidelines are a complete revision of the December 1994 (revised in October 1999) DOT Urine Specimen Collection Procedures Guidelines, 49 CFR Part 40, for Transportation Workplace Drug Testing Programs. These guidelines contain all of the new requirements and procedures contained in the DOT rule published in the Federal Register on December 19, 2000, effective August 1, 2001, and in the Technical Amendments, published on August 9, 2001. It contains minimal graphics and formatting to ease transmission and downloading of the document from the Internet. All previous amendments and interpretations are superseded and no longer in effect. All information appearing in these guidelines is in the public domain and may be used or reproduced without permission from DOT or others. Citation of the source is appreciated. Note: All DOT-required collections are conducted using split specimen procedures. There are no exceptions to this requirement. Note: If an alcohol test is also required, the alcohol test should be conducted first, if practicable. This document may be updated or modified based on additional interpretations or other procedural changes. Collectors and service agents should check the DOT web site periodically to ensure that they have the latest version (www.dot.gov/ost/dapc/). Revised December 2006 Previous editions are obsolete Office of Drug and Alcohol Policy and Compliance Revised December 2006 ADD-2 DOT Urine Specimen Collection Guidelines 3 INTRODUCTION The Department of Transportation's (DOT) operating administrations (Federal Aviation Administration, Federal Motor Carrier Safety Administration, Federal Railroad Administration, Federal Transit Administration, Research and Special Programs Administration, and the United States Coast Guard) have issued regulations requiring anti-drug programs in the aviation, highway, railroad, mass transit, pipeline, and maritime industries. The DOT operating administrations' rules require that employers conduct drug testing according to provisions of 49 CFR Part 40, "Procedures for Transportation Workplace Drug Testing Programs," Final Rule, published in the Federal Register on December 19, 2000 (65 FR 79462), effective August 1, 2001, together with subsequent technical amendments. Previously published rules, amendments, interpretations, and guidelines are no longer in effect. The procedures for collection of urine under these rules are very specific and must be followed whenever a DOT-required urine specimen collection is performed. (The only exception is the Federal Railroad Administration's Post-Accident Toxicological Testing Program in which a railroad representative will provide the collector specific instructions and a testing kit.) These procedures, including use of the Federal Drug Testing Custody and Control Form (CCF), apply only to DOT-required testing. While employers may use these collection and testing procedures for testing under employer or state authority, they must not use a Federal CCF nor can they imply that company tests are conducted using DOT authority. The collector has a major role in the success of the DOT’s drug testing program. The collector is the one individual in the testing process with whom all employees have direct, face-to-face contact. Without the collector assuring the integrity of the specimen and collection process, the test itself may lose validity. Without the collector's sensitivity to an employee's privacy, the entire testing program may be subject to criticism. It is imperative that collectors fully understand and follow these procedures. These guidelines, together with 49 CFR Part 40 and the DOT operating administrations' rules, will provide collectors with the information needed in the performance of their collection duties. The information in this document addresses normal collection procedures and some of the more common problems or situations encountered. However, information contained in this publication should not be used to interpret the legal requirements of the actual rule. Office of Drug and Alcohol Policy and Compliance Revised December 2006 ADD-3 DOT Urine Specimen Collection Guidelines 4 TABLE OF CONTENTS Section 1. Collector Section 2. Collection Site Section 3. Collection Supplies Section 4. Federal Drug Testing Custody and Control Form Section 5. Employee Identification Section 6. Collection Procedures Section 7. Shy Bladder Procedures Section 8. Directly Observed Collections Section 9. Monitored Collections Section 10. Problem Collections Section 11. Blind Quality Control Samples Section 12. Correcting Collection Problems Section 13. DOT-regulated and Non-Regulated Employers Appendix A DOT Standards for Urine Collection Kits Appendix B Training Requirements for Collectors Appendix C Questions and Answers Appendix D Operating Administrations’ Rules (Summary) SECTION 1. COLLECTOR Part 40 defines a collector as a trained person who instructs and assists employees at a collection site, who receives and makes an initial inspection of the urine specimen provided by those employees, and who initiates and completes the Federal Drug Testing Custody and Control Form (CCF). Note: DOT does not require or provide collector certification. Collectors need to have documentation reflecting that they have met appropriate training requirements. Any individual, who has received training specified in 49 CFR Part 40 (40.33) for conducting the required collection procedure, may serve as a collector except in the following situations: 1. The immediate supervisor of a particular employee may not act as the collector when that employee is tested, unless no other collector is available and the supervisor is permitted to do so under a DOT operating administration’s drug and alcohol regulation. (The immediate supervisor may act as a monitor or observer (same gender) if there is no alternate method at the collection site to conduct a monitored or observed collection.); 2. An employee who is in a safety-sensitive position and subject to the DOT drug testing rules should not be a collector, an observer, or a monitor for co-workers who are in the same testing pool or who work together with that employee on a daily basis. This is to preclude any potential appearance of collusion or impropriety; 3. An individual working for an HHS-certified drug testing laboratory (e.g., as a Office of Drug and Alcohol Policy and Compliance Revised December 2006 ADD-4 DOT Urine Specimen Collection Guidelines 5 technician or accessioner) may not act as a collector if that individual can link the employee with the specimen drug test result or laboratory report; and, 4. The employee may not be the collector of his or her own urine specimen. Note: To avoid a potential conflict of interest, a collector should not be someone that is related to the employee (e.g., spouse, ex-spouse, relative) or a close personal friend (e.g., fiancée). A collector should have appropriate identification, which includes the collector’s name and the name of the Collection Company or clinic. The collector is required to provide his or her identification if requested by the employee. There is no requirement for the collector to have a picture I.D. or to provide his or her driver's license with an address or telephone number. Also, the collector is not required to provide any certification or other documentation to the employee documenting the collector's training. However, the collector must provide this documentation on request to DOT agency representatives and to employers and service agents (SA) or Consortia/Third Party Administrators (C/TPAs) who are using or negotiating to use that collector’s services. As the collector, you must have the name and telephone number of the appropriate Designated Employee Representative (DER) and of the SA or C/TPA, where applicable, to contact about any problems or issues that may arise during the collection process. SECTION 2. COLLECTION SITE A collection site is a place (permanent or temporary) selected by the employer where employees present themselves for the purpose of providing a urine specimen for a DOT-required drug test. Generally, there are two types of collection facilities: 1. A single-toilet restroom, with a full-length privacy door, or 2. A multi-stall restroom, with partial-length doors. A collection site must have: 1. A restroom or stall with a toilet for the employee to have privacy while providing the urine specimen. Whenever available, a single toilet restroom, with a full-length privacy door, is preferred. All types of restrooms including a mobile facility (e.g., a vehicle with an enclosed toilet) are acceptable. 2. A source of water for washing hands that, if practical, is external to the restroom where urination occurs. If the only source of water available is inside the restroom, the employee may wash his or her hands, and then the collector must secure (e.g., use tamper-evident tape, cut off the water supply) the water source before the collection takes Office of Drug and Alcohol Policy and Compliance Revised December 2006 ADD-5 DOT Urine Specimen Collection Guidelines 6 place. If water is not available at the collection site, the collector may provide moist towelettes outside the restroom. 3. A suitable clean surface for the collector to use as a work area and for completing the required paper work. A second type of facility for urination, which can be used as a collection site, is a multi-stall restroom. Such a site must provide substantial visual privacy (e.g., a toilet stall with a partial- length door) and meet all other requirements listed above (2 and 3). Additionally, if a multi-stall restroom is used, the collector must either: 1. Secure all sources of water and other substances that could be used for adulteration and substitution (e.g., water faucets, soap dispensers) and place bluing agent in all toilets or secure the toilets to prevent access; or 2. Conduct all collections as monitored collections (See Section 9). No one but the employee may be present in the multi-stall restroom during the collection, except the monitor in the event of a monitored collection or the observer in the event of a directly observed collection. Note: The collector’s work area may be located outside the restroom. However, if there is no appropriate space available outside the restroom to serve as a secure, clean work area and the restroom is either a multi-stall facility or a single stall facility with a partial door for privacy, and is large enough to accommodate a work area, the collector may locate the work area inside the restroom as long as all procedures for a monitored collection are met. All collection sites must meet the following security requirements by having: 1. Procedures or restrictions to prevent unauthorized access to the site during the collection; 2. Procedures to prevent the employee or anyone else from gaining unauthorized access to the collection materials/supplies. The collector must also ensure that the employee does not have access to items that could be used to adulterate or dilute the specimen (e.g., soap, disinfectants, cleaning agents, water); 3. Procedures to ensure that all authorized persons are under the supervision of a collector or appropriate site personnel at all times when permitted into the site; and, 4. Procedures to provide for the secure handling and storage of specimens. Note: The testing site is that portion of the facility where the collector performs the paper work, seals the specimens, and where urination occurs. It does not necessarily include the total physical facility (e.g., clinic). Additionally, Office of Drug and Alcohol Policy and Compliance Revised December 2006 ADD-6 DOT Urine Specimen Collection Guidelines 7 unauthorized personnel are any individuals that are not specifically authorized by the regulation, the collector, or employer to be present at the collection site. SECTION 3. COLLECTION SUPPLIES The following items must be available at the collection site in order to conduct proper collections: 1. For each DOT drug test, a collection kit meeting the requirements listed at Appendix A of these guidelines. 2. Federal Drug Testing Custody and Control Forms (CCF). 3. Bluing (coloring) agent to add to the toilet bowl/water tank to prevent an employee from diluting the specimen. 4. Single use disposable gloves are recommended for use by collectors while handling specimens. 5. The collector should have available tamper-evident tape for securing faucets, toilet tank tops, and other appropriate areas, and signs, when necessary, that can be posted to prevent entry into collection areas. SECTION 4. FEDERAL DRUG TESTING CUSTODY AND CONTROL FORM The Federal Drug Testing Custody and Control Form (CCF OMB No. 0930-0158, Exp. Date: 6/30/2003) must be used to document every urine collection required by the DOT drug testing program. The CCF must be a five-part carbonless manifold form. This form may be viewed on the DOT web site (http://www.dot.gov/ost/dapc/) or the Department of Health and Human Services (HHS) web site http://workplace.samhsa.gov/. CCFs are also available from a number of different sources (e.g., laboratories, service agents) although they are usually part of the urine collection kits provided by a laboratory. The CCF consists of the following five copies: Copy 1. Laboratory Copy - accompanies the specimen to the laboratory Copy 2. Medical Review Officer Copy - sent to the MRO Copy 3. Collector Copy - retained by the collector Copy 4. Employer Copy - sent to the employer Copy 5. Employee Copy - given to the employee The CCF is completed as follows: Step 1 (Copy 1). This step is completed by the collector or employer representative prior to the employee providing a urine specimen. The employer and MRO names, addresses, and telephone and fax numbers may be preprinted or handwritten. If the employer has designated a service Office of Drug and Alcohol Policy and Compliance Revised December 2006 ADD-7 DOT Urine Specimen Collection Guidelines 8 agent to receive the results from the MRO, the employer’s address may be omitted and the service agent’s address may be used. However, in all cases, the specific employer’s name, telephone and fax numbers must be included. A clinic or collection site name may not be used in lieu of an employer name. The collector enters the employee’s social security number or employee’s ID number after verifying the employee’s identity. The collector also marks the appropriate box to indicate the reason for the test and the appropriate box for the type of drug tests to be performed (all DOT drug tests are for five drugs). The collector then enters the information required for the collection site (this information may also be preprinted). The collector’s telephone number is critical, since the laboratory or the MRO may need to contact the collector if they have questions related to a collection. Step 2 (Copy 1). This step is completed by the collector after receiving the specimen from the employee and observing the temperature of the specimen. This step requires the collector to mark the appropriate box to indicate if the temperature of the specimen was within the required temperature range. This step also requires the collector to indicate whether it is a split specimen or single specimen collection, to indicate if no specimen was collected and why, or to indicate if it was an observed collection and why. Note: All DOT collections are split specimen collections and should never have the single specimen collection box checked. Step 3 (Copy 1). This step instructs the collector to seal and date the specimen bottles, have the employee initial the bottle seals after placing them on the bottles, and then instruct the employee to complete step 5 on the MRO copy (Copy 2). Step 5 (Copy 2; note this differs from the other steps in that the collector turns to Copy 2 for the employee to fill out and then turns back to Copy 1). This step is completed by the employee (listed as donor on the CCF). The employee reads the certification statement, prints his or her name, provides date of birth, daytime and evening telephone numbers, date of collection, and signs the form. After the employee completes this portion of the CCF, the collector reviews it to ensure that all the required information was provided. Step 4 (Copy 1). This step is initiated by the collector and then completed by the laboratory after the laboratory accessions the specimen. This step requires the collector to sign the form to certify that the specimen was collected, labeled, sealed, and released for shipment to the laboratory in accordance with Federal requirements. The collector is also required to note the time of the collection, the date of collection, and the specific name of the delivery service to whom the specimen is released for shipment to the laboratory. Note: There is no requirement for couriers, express carriers, or postal service personnel to add additional documentation to the chain of custody for the specimens during transit because they do not have direct access to the specimens or the CCF. Chain of custody annotations resume when the shipping container/package is opened and accessioned at the laboratory. Step 5(a) (Copy 1). This step is completed by the laboratory to report the test result of the Office of Drug and Alcohol Policy and Compliance Revised December 2006 ADD-8 DOT Urine Specimen Collection Guidelines 9 primary specimen. Step 5(b) (Copy 1). This step is completed by the laboratory to report the test result of the split specimen if the split specimen is tested. Step 6 (Copy 2). This step is completed by the MRO in reporting the results of the primary specimen to the employer. Step 7 (Copy 2). This step is completed by the MRO in reporting the results of the split specimen to the employer. The bottom area of Copy 1 is reserved for the tamper-evident specimen bottle seals/labels. There must be two seals/labels (i.e., one marked with the letter "A" to designate the primary specimen and the other marked with the letter "B" to designate the split specimen) to accommodate collecting split specimens. Each seal/label must have the same preprinted specimen identification number that appears at the top of the CCF. Each seal/label must also have a place for the collector to annotate the date of the collection and a place for the employee to initial each seal/label after it is placed on the specimen bottle. Note: No one (including collection site personnel or the collector) is permitted to require an employee to sign a consent, release, or waiver of liability, or indemnification agreement with respect to any part of the drug testing process. Collection sites (clinics) may not use “generic” consent forms for DOT-required urine specimen collections, even if their clinic policy requires consent from the general patient population. SECTION 5. EMPLOYEE IDENTIFICATION The employee must provide appropriate identification to the collector upon arrival at the collection site. Acceptable forms of identification include: 1. A photo identification (e.g., drivers license, employee badge issued by the employer, or any other picture identification issued by a Federal, state, or local government agency), or 2. Identification by an employer or employer representative, or 3. Any other identification allowed under an operating administration’s rules. Unacceptable forms of identification include: 1. Identification by a co-worker, 2. Identification by another safety-sensitive employee, 3. Use of a single non-photo identification card (e.g., social security card, credit card, union or other membership cards, pay vouchers, voter registration card), or Office of Drug and Alcohol Policy and Compliance Revised December 2006 ADD-9 DOT Urine Specimen Collection Guidelines 10 4. Faxed or photocopies of identification document. Note: If the employee cannot produce positive identification, the collector must contact a DER to verify the identity of the employee. The collection should not proceed until positive identification is obtained. However, if an owner/operator or other self-employed individual does not have proper identification, the collector should record in the remarks section that positive identification is not available. The owner/operator must be asked to provide two items of identification bearing his/her signature. The collector then proceeds with the collection. When the owner/operator signs the certification statement, the collector compares the signature on the CCF with signatures on the identification presented. If the signatures appear consistent, the collection process continues. If the signature does not match signatures on the identification presented, the collector makes an additional note in remarks section stating "signature identification is unconfirmed." SECTION 6. COLLECTION PROCEDURES The collector must do the following before each collection to deter potential tampering, adulteration, alteration, or substitution of the specimens: 1. Secure any water sources or otherwise make them unavailable to employees (e.g., turn off water inlet, tape handles to prevent opening faucets); 2. Ensure that the water in the toilet and tank (if applicable) has bluing (coloring) agent in it. Tape or otherwise secure shut any movable toilet tank top, or put bluing in the tank; 3. Ensure that no soap, disinfectants, cleaning agents, or other possible adulterants are present; 4. Inspect the site to ensure that no foreign or unauthorized substances are present; 5. Ensure that undetected access (e.g., through a door not in your view) is not possible; 6. Secure areas and items (e.g., ledges, trash receptacles, paper towel holders, under-sink areas) that appear suitable for concealing contaminants; and 7. Recheck items (1) through (6) following each collection to ensure the site’s continued integrity. If the collection site uses a facility normally used for other purposes, such as a public restroom or hospital examining room, the collector must also ensure before the collection that: 1. Access to collection materials and specimens is effectively restricted; and Office of Drug and Alcohol Policy and Compliance Revised December 2006 ADD-10 DOT Urine Specimen Collection Guidelines 11 2. The facility is secured against access during the procedure to ensure privacy to the employee and prevent distraction of the collector. Limited-access signs must be posted. To avoid distraction that could compromise security, the collector is limited to conducting a collection for only one employee at a time. However, during the 3 hour time period that an employee is consuming fluids (shy bladder), the collector may conduct a collection for another employee. In this case, the employee with the shy bladder must be properly monitored (see Section 7). When a specific time for an employee's test has been scheduled, or the collection site is at the employee’s work site, and the employee does not appear at the collection site at the scheduled time, the collector must contact the DER to determine the appropriate interval within which the DER has determined the employee is authorized to arrive. If the employee's arrival is delayed beyond that time, the collector must notify the DER that the employee has not reported for testing. Note: For a pre-employment test, if an employee fails to appear, fails to provide a urine specimen, or fails to remain at the collection site, this is not considered a refusal provided the employee left the testing site or did not provide a specimen before the testing process commenced (i.e., the employee was given the collection kit or cup by the collector). The following steps describe a typical urine collection conducted under the DOT-mandated procedures: 1. The collector prepares the collection site to collect urine specimens. All collection supplies must be available, the area properly secured, water sources secured, and bluing (coloring) agent placed in all toilets as specified in Sections 2 and 3 of these guidelines. 2. The collector begins the collection without delay after the employee arrives at the collection site. Do not wait because the employee is not ready or states he or she is unable to urinate. In most cases, employees who state they cannot provide a specimen will, in fact, provide sufficient quantity to complete the testing process. (If an alcohol breath test is also scheduled, the alcohol test should be conducted first, if practicable.) 3. The collector requests the employee to present an acceptable form of identification. If the employee cannot produce positive identification, the collector must contact the DER to verify the identity of the employee (see Section 5). If the employee asks the collector to provide identification, the collector must show the employee some form of identification. It must include the collector’s name and the employer’s (or collection site) name. It does not have to be a picture identification or include the collector’s home address or telephone number. 4. The collector explains the basic collection procedures to the employee and reviews the instructions on the back of the CCF with the employee. 5. The collector ensures that the required information is provided at the top of the CCF (the laboratory name and address and a pre-printed specimen ID number which matches the ID Office of Drug and Alcohol Policy and Compliance Revised December 2006 ADD-11 DOT Urine Specimen Collection Guidelines 12 number on the specimen bottle seals). If the information is not already preprinted, the collector begins entering the required information in Step 1 of the CCF (employer's name, address, telephone and fax number, and I.D. number (if applicable); MRO name, address, telephone and fax number; employee SSN or employee ID number (refusal by the employee to provide a SSN is not a refusal to test, but requires the collector to annotate this in the remarks); reason for test; drug test to be performed; and collection site information). Note: Part 40 requires a specific MRO's name and address on the CCF rather than the name of the clinic or medical facility. An employer must provide to the collector the name and telephone number of the appropriate DER. This may be part of the CCF information that is pre-printed or may be under separate documentation. If there is no employer or DER telephone number on the CCF, the collector should write in the DER name and telephone number on the CCF (if this information is available) so that either the collector or the MRO may get in touch with a company representative when any problems arise related to that specimen. 6. The collector asks the employee to remove any unnecessary outer clothing (e.g., coat, jacket, hat, etc.) and to leave any briefcase, purse, or other personal belongings he or she is carrying with the outer clothing. The employee may retain his or her wallet. If the employee asks for a receipt for any belongings left with the collector, the collector must provide one. Note: To safeguard employee’s belongings, procedures may be established where the belongings are locked (at the collection site or in the bathroom) or other alternate methods may be developed. For example, if an employee comes to the collection site with his or her medications and desires that the collector secure the medication, the collector may place the medication in a locked cabinet, if available, or alternately, could seal the medication in an envelope, secure the envelope with tamper-evident tape and retain the envelope in a secure place. Note: The collector may encourage the employee to also leave, with his or her other belongings, any other items that the employee will not need or may be prohibited from carrying into the restroom. Note: The employee must not be asked to remove other articles of clothing, such as shirt, pants, dress, or under garments. Additionally, the employee must not be requested or required to remove all clothing in order to wear a hospital or examination gown. An exception may be made, if the employee is also undergoing a physical examination authorized by a DOT operating administration’s rule, in conjunction with the drug test, which normally includes wearing a hospital gown. Work boots or cowboy boots do not have to be removed unless the collector has a reason to suspect that the employee has something in them, which may be used to adulterate or substitute a specimen. When an employee is asked to remove his or her hat or head covering, and refuses to do so based on religious practice, the collector may exempt the employee from removal of the head covering, unless the collector has an observable indicator that the employee is attempting Office of Drug and Alcohol Policy and Compliance Revised December 2006 ADD-12 DOT Urine Specimen Collection Guidelines 13 to hide inside the head covering adulterants or other substances which may be used in an attempt to adulterate or substitute a specimen. 7. The collector directs the employee to empty his or her pockets and display the items to ensure that no items are present that could be used to adulterate the specimen. If nothing is there that can be used to adulterate a specimen, the employee places the items back into the pockets and the collection procedure continues. If the employee refuses to empty his or her pockets, this is considered a refusal to cooperate in the testing process. Note: If an item is found that appears to have been brought to the collection site with the intent to adulterate the specimen, a directly observed collection procedure becomes a requirement. If the item appears to be inadvertently brought to the collection site, secure the item and continue with the normal collection procedure. For example, a bottle of eye drops may have been brought inadvertently and would have to be secured by the collector and the collection would proceed. However, a bottle of liquid or urine would suggest intent to tamper with the specimen and a directly observed collection would be required. Whatever the employee brings into the collection site, the collector should return it to the employee at the end of the collection. Items, such as suspected urine, plastic bags with fluid in them, artificial or mechanical objects for providing substituted urine, etc., should be fully described in an attached memorandum for record, copies of which should be sent to the MRO and the employer. 8. The collector instructs the employee to wash and dry his or her hands, under the collector's observation, and informs the employee not to wash his or her hands again until after the employee provides the specimen to the collector. The employee must not be allowed any further access to water or other materials that could be used to put into the specimen. Note: The employee may use soap and, if practicable, it should be a liquid or cream. A solid bar of soap gives the employee the chance to conceal soap shavings under his or her fingernails and subsequently use them to attempt to adulterate the specimen. 9. The collector either gives the employee or allows the employee to select the collection kit or collection container (if it is separate from the kit) from the available supply. Either the collector or the employee, with both present, then unwraps or breaks the seal of the kit or collection container. Note: Even if the collection kit is sealed, the collection container must still be sealed or individually wrapped in a plastic bag or shrink wrapping; or must have a peelable, sealed lid or other easily visible tamper-evident system. Do not unwrap or break the seal on any specimen bottle at this time. Unwrap only the collection container. Note: Ensure the employee takes only the collection container into the room used for urination. The sealed specimen bottles remain with the collector. 10. The collector directs the employee to go into the room used for urination, provide a specimen of at least 45 mL, not to flush the toilet, and return with the specimen as soon as possible after Office of Drug and Alcohol Policy and Compliance Revised December 2006 ADD-13 DOT Urine Specimen Collection Guidelines 14 completing the void. (In many restrooms, a toilet tank into which bluing agent may be placed is not accessible to the collector. When the employee flushes the toilet, he or she can use the clear (un-blued) water to potentially dilute the specimen. Inadvertently flushing the toilet does not automatically require any corrective action by the collector or a recollection. However, to guard against this action, the collector may want to place a card with instructions not to flush by the toilet handle or tape or otherwise secure the handle with tamper-evident tape.) The collector may set a reasonable time limit for the employee to be inside the bathroom and this time frame should be explained to the employee. Note: The collector should also tell the employee that the temperature of the specimen is a critical factor and that the employee should bring the specimen to the collector as soon as possible after urination. The collector should inform the employee that if it is longer than 4 minutes from the time the employee urinates into the container and the collector takes the specimen temperature, the potential exists that the specimen may be out of range and an observed collection may be required. Note: The collector should pay close attention to the employee during the entire collection process to note any conduct that clearly indicates an attempt to substitute or adulterate a specimen. If the collector detects such conduct, and the employee has already provided a specimen, the collection process for this specimen is completed, and then the collector immediately begins a new collection under direct observation using a second CCF and a new kit. The collector then provides an appropriate comment on the "Remarks" line in Step 2 on the first CCF and second CCF indicating that this is the first of two or second of two (i.e., 1 of 2, 2 of 2) collections, the specimen ID numbers of the first and second CCF, the reason for the second collection, and that the second collection was under direct observation (check appropriate box in Step 2 of the CCF). This will ensure that the laboratory and the MRO know that two separate specimens are being submitted for testing; the first one possibly being adulterated or substituted. Additionally, the collector must inform the collection site supervisor and the DER that a collection took place under direct observation and the reason for having done so. 11. After the employee gives the specimen to the collector, the collector must check the temperature of the specimen, check the specimen volume, and inspect the specimen for adulteration or substitution. The collector should check the temperature of the specimen as soon as the employee hands over the specimen, but no later than four minutes after the employee comes out of the restroom. The acceptable temperature range is 32°-38°C/ 90°-100°F. Temperature is determined by reading the temperature strip originally affixed to or placed on the outside of the collection container. If the temperature is within the acceptable range, the "Yes" box is marked in Step 2 on the CCF and the collector proceeds with the collection procedure. (If the temperature is out of range, the collector marks the “No” box in Step 2 and initiates an observed collection.) The collector then checks to make sure that the specimen contains a sufficient amount of urine (a minimum of 45 mL for all DOT collections). If the volume is sufficient, the collector checks the box on the CCF (Step 2) indicating that this was a split specimen collection. (This may be done at the same time that the collector checks the temperature box.) The collector must inspect the specimen for unusual color, presence of foreign objects or material, or other signs of tampering or adulteration. If it is apparent from this Office of Drug and Alcohol Policy and Compliance Revised December 2006 ADD-14 DOT Urine Specimen Collection Guidelines 15 inspection that the employee has adulterated or substituted the specimen (e.g., the specimen is blue, exhibits excessive foaming when shaken, has smell of bleach), a second collection using direct observation procedures must be conducted immediately. If the temperature is outside the acceptable range, the volume is less than 45 mL, or the specimen may have been adulterated, the collector follows procedures in Section 10. Problem Collections. 12. After the employee hands the collection container to the collector, the collector unwraps or opens the specimen bottles. (The employee may be permitted to do this, however, the recommended “best practice” is for the collector to perform this procedure.) Bottles may be shrink-wrapped or secured by other easily discernable tamper-evident methodology and may be wrapped separately or together. Note: Both the collector and employee will maintain visual contact of the specimen to the greatest extent possible until the labels/seals are placed over the specimen bottle caps/lids. If practical, the collector may permit the employee to wash his or her hands right after the employee gives the collection container to the collector (and the collector checked the temperature), provided the employee and the collector can still maintain visual control of the specimen collection container. 13. The collector, not the employee, then pours at least 30 mL of urine from the collection container into a specimen bottle and places the lid/cap on the bottle. This will be the primary specimen or "A" bottle. The collector, not the employee, then pours at least 15 mL into a second bottle and places the lid/cap on the bottle. This will be the "B" bottle used for the split specimen. (The collector may first pour the requisite amount of specimen into each bottle and then secure the lids/caps on each bottle.) Note: The collector should not fill the primary or split specimen bottle up to the cap because a completely full bottle is more likely to leak in transit. Additionally, when a split specimen bottle is full and subsequently frozen, it may cause the bottle material to crack and then leak during transit as the specimen thaws. 14. The collector, not the employee, must then remove the tamper-evident seals from the CCF and place them on each bottle, ensuring that the seal labeled as “A” is placed on the primary bottle with at least 30 mL of urine and that the seal labeled as “B” is placed on the bottle with 15 mL of urine. The seal must be centered over the lid/cap and down the sides of the bottle to ensure that the lid/cap cannot be removed without destroying the seal. The collector, not the employee, writes the date on the seals. The employee is then requested to initial the seals. The employee must be present to observe the sealing of the specimen bottles. If the employee fails or refuses to initial the seals, the collector must note this in the “Remarks” line of the CCF and complete the collection process; this is not considered a refusal to test. Note: The collector must not ask the employee to initial the labels/seals while they are still attached to the CCF; they must be initialed after they are placed on the bottles. The collector should also inform the employee to use care during the initialing process to avoid damaging the labels/seals. Office of Drug and Alcohol Policy and Compliance Revised December 2006 ADD-15 DOT Urine Specimen Collection Guidelines 16 Note: Occasionally, the tamper-evident label/seal provided with the CCF will not properly adhere to the specimen bottle because of environmental conditions (e.g., moisture, temperature, specimen bottle material) or may be damaged or broken during the collection process. When this occurs, the collector should use the following corrective procedures: (a) If the seal is broken while being removed from the chain of custody form or during the application of the first seal on the primary bottle, the collector should transfer the information to a new CCF and use the seals from the second form. (b) If one seal is already in place on a bottle and the second seal is broken while being removed from the CCF or is broken during application on the second bottle or while the employee is initialing either seal, the collector should initiate a new CCF and provide an appropriate comment on the “Remarks” line in Step 5. The seals from the second CCF should be placed perpendicular to the original seals to avoid obscuring information on the original seals and must be initialed by the employee (both sets of employee initials should match). The collector should draw a line through the Specimen ID number and bar code (if present) on the original seals to ensure that the laboratory does not use that number for reporting the results. The collector should not pour the specimen into new bottles. (c) In both cases, the collector should ensure that all copies of the original (first) chain of custody form are destroyed or disposed of properly (e.g., shredded, torn into pieces). (d) If the collector inadvertently reverses the seals (i.e., places the “A” bottle seal on the split bottle and vise-versa) and the collector subsequently notices this, the collector should note this in the “Remarks” line and continue the collection process. Laboratories have procedures that permit them to “re-designate” the bottles. Note: There is no corrective procedure available if the seal is broken after the employee leaves the collection site. Note: Since the specimen bottle is now sealed with tamper-evident tape and does not have to be under the employee's direct observation, the employee is allowed to wash his or her hands if he or she desires to do so. 15. The collector directs the employee to read, sign, and date the certification statement, and provide date of birth, printed name, and day and evening contact telephone numbers in Step 5 of Copy 2 of the CCF. Note: If the employee refuses to sign the form or provide date of birth, printed name, or telephone numbers, the collector must make a notation on the "Remarks" line to that effect and complete the collection. If the employee refuses to fill out any information, the Office of Drug and Alcohol Policy and Compliance Revised December 2006 ADD-16 DOT Urine Specimen Collection Guidelines 17 collector must, as a minimum, print the employee’s name in the appropriate place. This does not constitute a refusal to test. 16. The collector completes the collector’s portion of the chain of custody on the CCF (Copy 1, Step 4) by printing his or her name (the name may be pre-printed), recording the date and time of the collection, signing where indicated, and entering the specific name of the delivery or courier service transferring the specimens to the laboratory. 17. The collector then ensures that all copies of the CCF are legible and complete. The collector removes Copy 5 from the CCF and gives it to the employee. Note: At this time, the collector can suggest that the employee list any prescription and over-the-counter medications he or she may be taking on the employee’s copy (Copy 5) of the CCF, but not on any other copy. This information may help the employee remember what medications he or she may have taken if a positive result is reported by the laboratory to the MRO. 18. The collector places the specimen bottles and Copy 1 of the CCF inside the appropriate pouches of the leak-resistant plastic bag, and seals both pouches. If the employee has not had the opportunity to wash his or her hands, they may do so now. The collector then informs the employee that he or she may leave the collection site. 19. Any urine specimen left over in the collection container after both specimen bottles have been appropriately filled and sealed should be discarded at this time. Excess urine may be used to conduct clinical tests (e.g., protein, glucose) if the collection was conducted in conjunction with a physical examination required by a DOT operating administration’s regulation. No further testing (e.g., adulteration testing, DNA, additional drugs) may be conducted on this excess urine and the employee has no right to demand that the excess urine be turned over to the employee. 20. The collector places the sealed plastic bag in an appropriate shipping container (e.g., box, express courier mailer) designed to minimize the possibility of damage during shipment. More than one sealed plastic bag can be placed into a single shipping container if there are multiple collections. The collector seals the shipping container as appropriate. If a laboratory courier hand-delivers the specimens from the collection site to the laboratory, the collector prepares the shipment as directed by the courier service. In this case, the plastic bag may not need to be placed into a shipping container, but still needs to be transported by the courier in a manner that protects the bottles from damage. Note: If the laboratory courier does not hand-deliver the specimens to the laboratory, but subsequently places the specimens into a commercial delivery system, the specimens must be placed into a shipping container to minimize damage in transit. 21. The collector then sends Copy 2 of the CCF to the MRO and Copy 4 to the DER (or service agent if authorized by the employer). The collector must fax or otherwise transmit these copies to the MRO and DER within 24 hours or during the next business day and keep Copy 3 for at least 30 days, unless otherwise specified by applicable DOT operating administration’s regulations. Office of Drug and Alcohol Policy and Compliance Revised December 2006 ADD-17 DOT Urine Specimen Collection Guidelines 18 Note: The MRO copy (Copy 2) may be faxed to the MRO’s secure fax machine, it may be scanned and the image sent to the MRO’s secure computer, or it may be mailed or sent by courier to the MRO. (It is recommended that the MRO copy be faxed, since it is critical for the MRO to have this document to expeditiously conduct the verification process.) In the case where the MRO copy (Copy 2) is faxed or the scanned image is sent securely to the MRO, the collector or the collection site should maintain the MRO copies together with the collector’s copies for 30 days. Retention is in case the MRO’s copy is lost in the mail or the faxed or scanned copy is not legible and another copy is required by the MRO. The transmission process must be coordinated between the collection site and the MRO to ensure that transmission procedures meet the MRO’s requirements (e.g., MROs must provide secure fax numbers to collection sites, some MROs may want hard copies mailed; others may want only faxed copies). 22. The collector or collection site must ensure that each specimen collected is shipped to a laboratory as quickly as possible, but in any case within 24 hours or during the next business day. 23. If the specimen will not be shipped immediately, the collector is responsible for ensuring its integrity and security. Specimens in plastic bags, which have not been placed into shipping containers or which are awaiting a laboratory courier, must be kept in a secure location. The specimens need not be under lock and key, however, procedures must exist that would ensure specimens cannot be subject to tampering. Note: After specimens are placed into shipping containers that are subsequently sealed, the shipping containers may be placed with other containers or packages that the collection site has waiting to be picked up by a courier. It is expected that collection sites will use reasonable security to ensure that all of their packages are relatively secure and not subject to damage, theft, or other actions that would potentially raise questions related to the integrity of the specimens. Note: Couriers, postal employees, and other personnel involved in the transportation of the sealed shipping container are not required to make, and should not attempt to make, additional chain of custody entries on the custody and control form. The collection process is now complete. SECTION 7. SHY BLADDER PROCEDURES The term "shy bladder" refers to a situation when the employee does not provide a sufficient amount of urine (45 mL) for a DOT-required drug test. If an employee tells the collector, upon arrival at the collection site, that he or she cannot provide a specimen, the collector must still begin the collection procedure regardless of the reason given. The collector should tell the employee that most individuals can provide 45 mL of urine, even when they think they cannot urinate, and direct the employee to make the attempt to provide the specimen. Office of Drug and Alcohol Policy and Compliance Revised December 2006 ADD-18 DOT Urine Specimen Collection Guidelines 19 At the point in the collection procedure where the collector and employee unwrap/open a collection container, the collector does the following: 1. The collector requests the employee to go into the rest room and try to provide a specimen. Note: The employee demonstrates his or her inability to provide a valid specimen when the employee comes out of the rest room with an insufficient quantity of specimen or an empty collection container. 2. If the employee provided an initial insufficient specimen, the collector discards the insufficient specimen. The collector then annotates in the “Remarks” line the time when the employee provided the insufficient specimen. This is the time when the “shy bladder” collection process starts. Note: If there was actually no specimen provided on an attempt, the same collection container may be used for the next attempt (the employee may keep possession of the container during the waiting period). The collector uses the same CCF and continues to document subsequent collections on the same form. Note: If the insufficient specimen is also out of temperature range (assuming there was sufficient specimen to activate the temperature strip) or shows evidence of adulteration or tampering, the collector completes the collection process, sends the insufficient specimen (temperature out of range or adulterated) to the laboratory and immediately initiates another collection under direct observation. 3. The collector explains to the employee the process for a shy bladder collection and urges the employee to drink up to 40 ounces of fluids, distributed reasonably through a period of up to three hours, or until the individual has provided a sufficient urine specimen, whichever occurs first. It is not a refusal to test if the employee declines to drink. Note: Collectors should be sensitive to how frequently they should ask the employee to provide a specimen. For example, asking the employee to provide a specimen every half hour may not produce sufficient specimen, although in total, the amount would have been at least 45 mL. In this case, the collector needs to determine if a longer time is needed for the employee to consume fluids and produce a sufficient volume of specimen. If the employee refuses to drink fluids, this is not considered a refusal to test, although the collector should explain to the employee that not drinking sufficient fluids may result in the employee’s inability to provide a sufficient specimen and would require a medical evaluation. Under no circumstances can a collector “combine” urine collected from separate voids to create one specimen of sufficient volume. 4. If the employee refuses to make the attempt to provide a new urine specimen or leaves the collection site before the collection process is completed, the collector must Office of Drug and Alcohol Policy and Compliance Revised December 2006 ADD-19 DOT Urine Specimen Collection Guidelines 20 discontinue the collection, note the fact on the “Remarks” line of the CCF (Step 2), and immediately notify the DER. This is a refusal to test. 5. If the employee has not provided a sufficient specimen within three hours of the first unsuccessful attempt to provide the specimen, the collector must discontinue the collection, note the fact on the “Remarks” line of the CCF (Step 2), and immediately notify the DER. Note: The collector should maintain a record in the “Remarks” line on the CCF of the time of each attempt, whether there was any specimen provided or the quantity of specimen provided, and the amount of fluids that the employee was given to drink. During the waiting time, the employee must be monitored by the collector (the one conducting the collection or another collector at the site) or by another responsible collection site staff member or a company representative. The collector must specifically tell the employee that he or she is not permitted to leave the collection site and if they do so, that it will be considered a refusal to test. 6. The collector then sends Copy 2 of the CCF to the MRO and Copy 4 to the DER. This is done even if the employee did not provide any specimen in order to notify the MRO and the employer of the problem. The collector must send or fax these copies to the MRO and DER within 24 hours or the next business day. SECTION 8. DIRECTLY OBSERVED COLLECTION A directly observed collection procedure is the same as a routine collection procedure with the additional requirement that an observer physically watches the employee urinate into the collection container. The observer must be the same gender as the employee; there are no exceptions to this requirement. An observed collection is required when: 1. The employer or DER directs the collector (or collection site) to conduct a collection under direct observation. Note: The employer is required to conduct a directly observed collection when the laboratory reports an invalid specimen and the MRO reports that there was not an adequate medical explanation for the result, or because the split specimen test could not be performed (e.g., split lost, inadequate volume). The employer may direct an observed collection if the test is a return-to-duty or follow-up test. An employee may not “volunteer” to have his or her specimen collected under direct observation. 2. The collector observed materials brought to the collection site or the employee’s conduct clearly indicated an attempt to tamper with a specimen. Office of Drug and Alcohol Policy and Compliance Revised December 2006 ADD-20 DOT Urine Specimen Collection Guidelines 21 3. The temperature on the original specimen was out of range or the specimen appeared to have been tampered with. Note: The collector may serve as the observer when the collector is the same gender as the employee. If not, the collector must call upon another individual (who is the same gender as the employee) to act as the observer. The collector must verbally instruct the observer as to the procedures the observer must follow and specifically inform the observer not to take the specimen from the employee, but have the employee bring it to the collector. It is recommended that the collector have a short written outline of the procedures to be used for an observed collection, review these procedures with the observer, and provide a copy of the written procedures to the observer, if the observer requests it. An observed collection is conducted in the following manner: 1. The collector must explain to the employee why a directly observed collection is being conducted. If the directly observed collection is requested by the employer, the collector may state the reason (if known) or may only state that the employer requested a directly observed collection. 2. The collector must complete a new CCF for the directly observed collection and mark the “reason for test” block (Step 1) the same as for the first collection (unless it is a return-to-duty or follow-up test). 3. The collector then checks the “Observed, (Enter Remark)” box and enters the reason in the “Remarks” line (Step 2) and the name of the observer if it is someone other than the collector. 4. In a case where two sets of specimens are being sent to the laboratory because of suspected tampering with the first specimen, the collector enters on the “Remarks” line of the CCF (Step 2) for each specimen a notation to this effect (e.g., collection 1 of 2, or 2 of 2) and the CCF specimen ID number of the other specimen. 5. The collector, if the same gender as the employee, or the same gender observer enters the restroom or facility where urination occurs with the employee. If it is a multi-stall restroom, the collector/observer must enter the stall with the employee. The collector/observer must watch the employee urinate into the collection container. Specifically, the collector/observer must personally and directly watch the urine go from the employee’s body into the collection container (use of mirrors or video cameras is not permitted). 6. After the employee has completed urinating into the collection container, the employee and observer leave the enclosed toilet stall/restroom and the employee hands the collection container directly to the collector. The observer must maintain visual contact of the collection container until the employee hands the container to the collector. If the Office of Drug and Alcohol Policy and Compliance Revised December 2006 ADD-21 DOT Urine Specimen Collection Guidelines 22 observer is the collector, the collector may receive the collection container from the employee while they are both in the enclosed toilet stall/restroom. 7. If the employee declines to allow a directly observed collection required or permitted by Part 40 to occur, the collector discards any specimen the employee provided previously and notifies the DER as soon as possible. This is considered a refusal to test. 8. If the collector learns that a directly observed collection should have taken place, but was not, the collector must inform the employer that the employee must be directed to return for an immediate recollection under direct observation. SECTION 9. MONITORED COLLECTIONS A monitored collection is one that is conducted under less than completely private conditions, utilizing a multi-stall restroom. If there is no practicable work place outside of the restroom, the collector may set up an area within the multi-stall restroom to be used as a work area and for finalizing the required paper work. (A collection which is not monitored may also be conducted in a multi-stall restroom, provided that the collector secures all of the stalls (bluing agent, etc.), secures all water sources and other potential sources of adulterants (soap dispensers) in the restroom, and posts signs or otherwise secures the restroom from entry by unauthorized personnel.) A monitored collection is conducted in the following manner: 1. The collector must secure the room being used for the monitored collection so that no one except the employee and the monitor can enter it until after the collection has been completed. 2. The monitor must be the same gender as the employee, unless the monitor is a medical professional (e.g., nurse, doctor, physician’s assistant, technologist or technician licensed or certified to practice in the jurisdiction in which the collection takes place). The monitor can be a different person from the collector and need not be a qualified collector. 3. If someone other than the collector is to monitor the collection procedure (i.e., the collector is not a medical professional), the collector must verbally instruct that person to use the following procedures (if the collector is the monitor, the collector must also follow these procedures): (a) A monitor stands outside the stall and does not watch the employee urinate. If the monitor hears sounds or makes other observations indicating an attempt to tamper with a specimen by the employee, there must be an additional collection conducted under direct observation. (b) A monitor must ensure that the employee takes the collection container directly to the collector as soon as the employee has exited the enclosure. Office of Drug and Alcohol Policy and Compliance Revised December 2006 ADD-22 DOT Urine Specimen Collection Guidelines 23 4. When someone besides the collector has acted as the monitor, the collector must note that person’s name in the “Remarks” line of the CCF (Step 2). 5. If the employee declines to permit a collection authorized under Part 40 to be monitored, it is a refusal to test. SECTION 10. PROBLEM COLLECTIONS CATHETERIZATION. If an employee needs medical attention (e.g., an injured employee in an emergency medical facility who is required to have a post-accident test), treatment takes priority and should not be delayed to collect a specimen. If an employee is catheterized as part of a medical procedure (following an accident), once the employee’s medical condition is stabilized and the employee can give his or her consent to the collection (e.g., understand that a DOT collection is required, can sign the CCF), a urine specimen should be obtained from that employee. Procedures similar to those listed below may be used when an external urine bag is involved. A urine specimen must not be collected, by catheterization or other means, from an unconscious employee to conduct a DOT-required drug test. Catheterization of a conscious employee to obtain a urine specimen for a DOT-required test is also not authorized. However, an employee who normally voids through intermittent or self-catheterization is required to provide a specimen in that manner if he or she is required to produce a specimen for a DOT test. If able to, the employee may provide the specimen directly from the catheter into the collection container in the privacy of a restroom. If an employee, who normally voids through self-catheterization, declines to do so, this would constitute a refusal to test. EXTERNAL URINE BAG. The following procedures should be used in the collection of a urine specimen from an employee who has a medical condition requiring an indwelling catheter or excretion of urine into an external bag. The urine specimen should be a freshly voided specimen. If an employee with an indwelling catheter may urinate directly into a collection container. In the case of an employee with an external bag, the employee should be asked to empty his or her bag in the privacy of a bathroom, show the empty bag to the collector, and then drink sufficient fluids at the collection site to provide 45 mL of urine, which can be subsequently poured by the employee from the bag into a collection container in the privacy of a bathroom. In this case, the temperature of the specimen would not be a critical factor. The collector should be keenly aware of the potential embarrassment that this type of collection can cause the employee and should conduct the collection with appropriate decorum. This procedure would not have to be done in a medical environment/health clinic or by a collector of the same gender, although the collector may try to accommodate the employee (e.g., conduct the collection at a medical facility, have the same gender collector) if the employee requests this and if it would not significantly delay the collection process. If the employer is aware of this situation prior to the actual collection (e.g., because the employee had previously expressed a desire to provide the specimen in a medical setting, requested a same gender collector, told the employer about the medical condition and its impact on urine collection for drug testing), the employer (collection site) may establish or modify procedures as needed to Office of Drug and Alcohol Policy and Compliance Revised December 2006 ADD-23 DOT Urine Specimen Collection Guidelines 24 permit the employee to provide a specimen in a way consistent with the employee’s privacy while still meeting regulatory requirements. In the case of a collection based on a post-accident or reasonable suspicion requirement, the collector may attempt to honor the employee’s request (for the collection to be conducted in a medical setting or for the collector to be the same gender) if the collection can be accomplished within a reasonable time frame. The above scenario assumes that the employee’s medical condition is not one that decreases or completely prohibits renal output, and that the employee can produce normal amounts of urine that is excreted into an external bag. Therefore, an employee with this or similar medical conditions would be subject to the same testing requirements (e.g., pre-employment, random) and to the “shy bladder” protocol (three hours and 40 ounces of fluids) as an employee with no medical condition. If an employee who normally voids in this manner declines to provide a urine specimen under these conditions, it would constitute a refusal to test. TEMPERATURE. The collector should check the temperature of the specimen as soon as the employee hands over the specimen, but no later than four minutes after the employee comes out of the restroom. The acceptable temperature range is 32°-38°C/ 90°-100°F. Temperature is determined by reading the temperature strip originally affixed to or placed on the outside of the collection container after the employee hands the specimen to the collector. (a) If the temperature is within the acceptable range, the "Yes" box is marked in Step 2 on the CCF and the collector proceeds with the collection procedure. (b) If the temperature is outside the acceptable range, the "No" box is marked in Step 2 on the CCF and if the temperature was below or above the acceptable range should be noted in the “Remarks” line. The collector completes the collection process for the “first” specimen and immediately begins a “second” collection under direct observation using a second CCF and a new kit. The collector then provides an appropriate comment on the "Remarks" line in Step 2 on the first CCF and second CCF indicating that this is the first of two or second of two collections, the specimen ID numbers of the first and second CCF, the reason for the second collection, and that the second collection was under direct observation. This will ensure that the laboratory and the MRO know that two separate specimens are being submitted for testing; the first one possibly being adulterated or substituted. Additionally, the collector must inform the collection site supervisor and the DER that a collection took place under direct observation and the reason for doing so. Note: There is no requirement to take the employee’s body temperature if the specimen temperature is out of range. If the collector suspects that the temperature strip was not activated, the collector should pour the urine specimen into another collection container with a temperature strip or into a specimen bottle which has a temperature strip attached, and use this method to determine the specimen temperature. Collectors should not introduce any other object (e.g., litmus paper, testing strips, etc.) into the specimen in the collection container or the bottles. Office of Drug and Alcohol Policy and Compliance Revised December 2006 ADD-24 DOT Urine Specimen Collection Guidelines 25 SPECIMEN VOLUME. The collector checks to make sure that the specimen contains a sufficient amount of urine (a minimum of 45 mL for all DOT collections). If the volume is sufficient, the collector checks the box on the CCF (Step 2) indicating that this was a split specimen collection. (This may be done at the same time that the collector checks the temperature box.) If the volume is less than 45 mL, the action taken will depend on whether the temperature of the specimen is in or outside the acceptable temperature range. (a) If the temperature is in the acceptable range, the specimen is discarded and a second specimen is collected. The collector may use the original CCF for the second specimen, but should annotate in the “Remarks” line the time that the first insufficient specimen was provided by the employee and the fact that this is a second collection (the time annotation is important since this may become a “shy bladder” situation). The collector should use a new specimen collection container, if these are available separately or a new kit. (b) If the temperature is outside the acceptable range, a second specimen must be collected under direct observation and both specimens are sent to the laboratory for testing. The collector must use a separate CCF and kit for each specimen and provide an appropriate comment on each CCF to indicate why two specimens were collected. ADULTERATION OR SUBSTITUTION. The collector must inspect the specimen for unusual color, presence of foreign objects or material, or other signs of tampering or adulteration. If it is apparent from this inspection that the employee has adulterated or substituted the specimen (e.g., the specimen is blue, exhibits excessive foaming when shaken, has smell of bleach), a second collection using direct observation procedures must be conducted immediately. The first specimen and the second specimen collected using direct observation are both sent to the laboratory for testing. The first specimen is always sent to the laboratory even though it may have had an insufficient volume, but showed signs of tampering. If the employee does not provide the required amount of urine for the second collection using direct observation, the collector annotates the time the second specimen was not provided and initiates the shy bladder procedures. If after 3 hours the employee still cannot provide a sufficient amount of specimen, the collector ends the collection process and informs the DER. The collector must send or fax Copy 2 of the CCF to the MRO and Copy 4 to the DER within 24 hours or the next business day. The collector must send the original specimen to the laboratory with an annotation that the specimen was suspected of being adulterated or substituted, that a second collection was attempted, but that a shy bladder prevented collection of a second specimen. Note: In a case where the employee refuses to provide another specimen or refuses to provide a specimen under direct observation, the collector discards any specimen the employee provided previously during the collection and then notifies the DER that the employee refused to comply with a DOT test. Office of Drug and Alcohol Policy and Compliance Revised December 2006 ADD-25 DOT Urine Specimen Collection Guidelines 26 SECTION 11. BLIND QUALITY CONTROL SAMPLES An employer or Consortia/Third Party Administrator (C/TPA) with an aggregate of 2000 or more DOT-covered employees, must send blind quality control samples to laboratories they use. If the employer or C/TPA have an aggregate of fewer than 2000 DOT-covered employees, they are not required to provide blind quality control samples. To each laboratory to which an employer or C/TPA sends at least 100 specimens in a year, they must transmit a number of blind quality control samples equivalent to one percent of the specimens sent to that laboratory, up to a maximum of 50 blind quality control samples in each quarter (i.e., January-March, April-June, July-September, October-December). A C/TPA must apply this percentage to the total number of DOT-covered employees' specimens it sends to the laboratory. Blind quality control sample submissions must be evenly spread throughout the year. Note: In general, the employer determines who will conduct the regulatory requirement for the employer to submit blind quality control samples. It may be the employer itself, the collection site, MRO, or the C/TPA. However, regardless of who purchases the blind quality control samples, they must be submitted through the normal collection procedures used by the employer and must be indistinguishable by the laboratory from normal specimens sent by the collection site for DOT testing. The collector always submits the blind quality control sample using the same CCF as that used for an employee specimen. The collector provides the required information to ensure that the CCF has been properly completed as well as providing fictitious initials on the specimen bottle labels/seals. Since there is no employee, the collector must indicate that the sample is a "blind quality control" on the MRO copy where the employee would normally provide a signature (Step 5 on Copy 2 of the CCF). Note: For a blind quality control sample, Copies 4 and 5 of the CCF (the employer and employee copy) may be discarded by the collector, unless the employer or the service agent requires the employer copy (in this case, the collector must ensure that the employer copy has the same “blind quality control” annotation as the MRO copy). All blind quality control samples must be submitted as DOT split specimen collections. Blind quality control samples may be obtained from companies listed on the HHS Internet web site (http://workplace.samhsa.gov/). SECTION 12. CORRECTING COLLECTION PROBLEMS When an HHS certified laboratory receives specimen bottles and the associated CCF, it checks to see if the specimen ID number on the specimen bottle labels/seals matches the number on the CCF, that the specimen bottle seals are intact, that there is sufficient specimen volume, and that the CCF has been properly completed by the collector. If there is any discrepancy and/or error of omission (i.e., the collector did not sign the chain of custody, the collector did not check the temperature box), the laboratory will contact the collector to determine if the discrepancy and/or missing information can be recovered. That is, the collector can provide a written memorandum attesting to the fact that he or she inadvertently forgot to properly document the CCF. Office of Drug and Alcohol Policy and Compliance Revised December 2006 ADD-26 DOT Urine Specimen Collection Guidelines 27 Note: If a fatal flaw exists in the collection process or a memorandum for record or other written statement cannot be provided by the collector to related to a correctable flaw, the laboratory will report "Rejected for Testing" to the MRO and provide an appropriate comment as to why the specimen was not tested. If the reason for rejecting the test was a collector error, when a test is cancelled by the MRO, the collector who collected the specimen will need to go through an error correction training process within 30 days addressing the specific problem that caused the specimen to be cancelled. Note: Once contacted by the laboratory or the MRO, the collector should immediately provide a statement or memorandum to recover the discrepancy and/or error of omission. Laboratories are required by HHS to retain these specimens for a minimum of 5 business days before they may be discarded; therefore, it is critical that the collector respond immediately to the laboratory’s request for corrective action. The collector has the responsibility of trying to successfully complete a collection procedure for each employee. 1. If, during or shortly after the collection process, the collector becomes aware of any event that prevents the completion of a valid test or collection (e.g., a procedural or paperwork error), the collector must try to correct the problem promptly, if doing so is practicable. The collector may initiate another collection as part of this effort. However, the collector must not recall an employee for another collection once the employee has left the collection site. There is one exception: when the collector learns that a directly observed collection should have been conducted, but was not, the collector must notify the employer to direct the employee to return for an immediate recollection under direct observation. 2. If another collection is necessary, the collector must begin the new collection procedure as soon as possible, using a new CCF and a new collection kit. Note: If the collector becomes aware of a problem that can be corrected, but which has not already been corrected, the collector must take all practicable actions to correct the problem so that the test is not cancelled. 3. If the problem resulted from the omission of required information, the collector must, as the person responsible for providing that information, supply in writing the missing information and a statement that it is true and accurate. For example, suppose the collector forgot to make a notation on the “Remarks” line of the CCF that the employee did not sign the certification. The collector would, when the problem is called to his or her attention, supply a signed statement that the employee failed or refused to sign the certification and that the collector’s statement is true and accurate. The collector must supply this information on the same business day on which he or she is notified of the problem, transmitting it by fax or courier. Office of Drug and Alcohol Policy and Compliance Revised December 2006 ADD-27 DOT Urine Specimen Collection Guidelines 28 Note: If the problem is the use of a non-Federal form, the collector must, as the person responsible for the use of the incorrect form, provide a signed statement that the incorrect form contains all the information needed for a valid DOT drug test, that the incorrect form was used inadvertently or as the only means of conducting a test, in circumstances beyond the collector’s control. The statement must also list the steps the collector has taken to prevent future use of non-Federal forms for DOT tests. For this flaw to have been corrected, the test of the specimen must have occurred at a HHS-certified laboratory where it was tested using the testing protocol in this part. The collector must supply this information to the laboratory on the same business day on which he or she is notified of the problem, transmitting it by fax or courier. 4. If the problem is the use of a non-Federal CCF or an expired Federal form, the collector must provide a signed statement (e.g., a memorandum for record). The documentation must state that the incorrect form contains all the information needed for a valid DOT drug test, and that the incorrect CCF was used inadvertently or as the only means of conducting a test, in circumstances beyond the collector’s control. The memorandum must also list the steps the collector took to prevent future use of non- Federal or expired Federal CCFs for DOT tests. This information must be supplied to the laboratory on the same business day that the collector is notified of the problem, and may be transmitted by fax or courier. 5. The collector must maintain a copy of the written and dated documentation of correction with the appropriate CCF. The collector must also mark the CCF in such a way (e.g., stamp noting correction, written notation) that it would be obvious on the face of the CCF that the corrected (missing) information was supplied. SECTION 13. DOT-REGULATED AND NON-REGULATED EMPLOYERS Employers regulated by the Department of Transportation (as well as Federal agencies) are required to use the OMB approved Federal Drug Testing Custody and Control Form for their workplace drug testing programs. All other employers or private sector companies and non-DOT testing conducted by DOT-regulated employers are prohibited from using the Federal CCF. (The Federal Railroad Administration has specific CCFs, which must be used for post-accident testing in the railroad industry.) In the rare instance where the collector, either by mistake or as the only means to conduct a test under difficult circumstances (e.g., post-accident test with insufficient time to obtain the CCF), uses a non-Federal form for a regulated collection, the use of a non-Federal form does not, in and of itself, present a reason for the laboratory to reject the specimen for testing or for the MRO to cancel the test. However, if the laboratory or the MRO discovers the use of the incorrect form, a signed statement must be obtained from the collector stating the reason why the Federal CCF was not used for the regulated collection. Office of Drug and Alcohol Policy and Compliance Revised December 2006 ADD-28 DOT Urine Specimen Collection Guidelines 29 APPENDIX A - DOT STANDARDS FOR URINE COLLECTION KITS 1. Collection Container a. Single-use container, made of plastic, large enough to easily catch and hold at least 55 mL of urine voided from the body. b. Must have graduated volume markings clearly noting levels of 45 mL and above. c. Must have a temperature strip providing graduated temperature readings 32-38 º C / 90-100 º F, that is affixed or can be affixed at a proper level on the outside of the collection container. Other methodologies (e.g., temperature device built into the wall of the container) are acceptable provided the temperature measurement is accurate and such that there is no potential for contamination of the specimen. d. Must be individually wrapped in a sealed plastic bag or shrink wrapping; or must have a peelable, sealed lid or other easily visible tamper-evident system. e. May be made available separately at collection sites to address shy bladder situations when several voids may be required to complete the testing process. 2. Plastic Specimen Bottles a. Each bottle must be large enough to hold at least 35 mL; or alternatively, they may be two distinct sizes of specimen bottles provided that the bottle designed to hold the primary specimen holds at least 35 mL of urine and the bottle designed to hold the split specimen holds at least 20 mL. b. Must have screw-on or snap-on caps that prevent seepage of the urine from the bottles during shipment. c. Must have markings clearly indicating the appropriate levels (30 mL for the primary specimen and 15 mL for the split) of urine that must be poured into the bottles. d. Must be designed so that the required tamper-evident bottle seals made available on the CCF fit with no damage to the seal when the employee initials it nor with the chance that the seal overlap would conceal printed information. e. Must be wrapped (with caps) together in a sealed plastic bag or shrink wrapping separate from the collection container; or must be wrapped (with cap) individually in sealed plastic bags or shrink wrapping; or must have peelable, sealed lid or other easily visible tamper-evident system. f. Plastic material must be leach resistant. 3. Leak-resistant Plastic Bag Office of Drug and Alcohol Policy and Compliance Revised December 2006 ADD-29 DOT Urine Specimen Collection Guidelines 30 a. Must have two sealable compartments or pouches which are leak-resistant; one large enough to hold two specimen bottles and the other large enough to hold the CCF paperwork. b. The sealing methodology must be such that once the compartments are sealed, any tampering or attempts to open either compartment will be evident. 4. Absorbent material Each kit must contain enough absorbent material to absorb the entire contents of both specimen bottles. Absorbent material must be designed to fit inside the leak-resistant plastic bag pouch into which the specimen bottles are placed. 5. Shipping Container a. Must be designed to adequately protect the specimen bottles from shipment damage in the transport of specimens from the collection site to the laboratory (e.g., standard courier box, small cardboard box, plastic container). b. May be made available separately at collection sites rather than being part of an actual kit sent to collection sites. c. A shipping container is not necessary if a laboratory courier hand-delivers the specimen bottles in the plastic leak-proof bags from the collection site to the laboratory. APPENDIX B - TRAINING REQUIREMENTS FOR COLLECTORS To be permitted to act as a collector in the DOT drug testing program, you must meet the following requirements: (a) Basic information. You must be knowledgeable about 49 CFR Part 40, the current “DOT Urine Specimen Collection Procedures Guidelines,” and DOT agency regulations applicable to the employers for whom you perform collections, and you must keep current on any changes to these materials. The DOT Urine Specimen Collection Procedures Guidelines document is available from ODAPC (Department of Transportation, 400 7th Street, S.W., Room 10403, Washington DC, 20590, 202-366-3784, or on the ODAPC web site (http://www.dot.gov/ost/dapc). (b) Qualification training. You must receive qualification training which provides instruction on the following subjects: (1) All steps necessary to complete a collection correctly and the proper completion and transmission of the CCF; (2) “Problem” collections (e.g., situations like “shy bladder” and attempts to tamper with a specimen); (3) Fatal flaws, correctable flaws, and how to correct problems in collections; and (4) The collector’s responsibility for maintaining the integrity of the collection process, ensuring the privacy of employees being tested, ensuring the security of the specimen, and avoiding conduct or statements that could be viewed as offensive or inappropriate; Office of Drug and Alcohol Policy and Compliance Revised December 2006 ADD-30 DOT Urine Specimen Collection Guidelines 31 (c) Initial Proficiency Demonstration. Following your completion of qualification training under paragraph (b) above, you must demonstrate proficiency in collections by completing five consecutive error-free mock collections. (1) The five mock collections must include two uneventful collection scenarios, one insufficient quantity of urine scenario, one temperature out of range scenario, and one scenario in which the employee refuses to sign the CCF and initial the specimen bottle tamper-evident seal. (2) Another person must monitor and evaluate your performance, in person or by a means that provides real-time observation and interaction between the instructor and trainee, and attest in writing that the mock collections are “error-free.” This person must be a qualified collector who has demonstrated necessary knowledge, skills, and abilities by -- (i) Regularly conducting DOT drug test collections for a period of at least a year; (ii) Conducting collector training under this part for a year; or (iii) Successfully completing a "train the trainer" course. (d) Schedule for qualification training and initial proficiency demonstration. The following is the schedule for qualification training and the initial proficiency demonstration you must meet: (1) If you became a collector before August 1, 2001, and you have already met the requirements of paragraphs (b) and (c) of this section, you do not have to meet them again. (2) If you became a collector before August 1, 2001, and have yet to meet the requirements of paragraphs (b) and (c) of this section, you must do so no later than January 31, 2003. (3) If you become a collector on or after August 1, 2001, you must meet the requirements of paragraphs (b) and (c) of this section before you begin to perform collector functions. (e) Refresher training. No less frequently than every five years from the date on which you satisfactorily complete the requirements of paragraphs (b) and (c) above, you must complete refresher training that meets all the requirements of paragraphs (b) and (c). (f) Error Correction Training. If you make a mistake in the collection process that causes a test to be cancelled (i.e., a fatal or uncorrected flaw), you must undergo error correction training. This training must occur within 30 days of the date you are notified of the error that led to the need for retraining. (i) Error correction training must be provided and your proficiency documented in writing by a person who meets the requirements of paragraph (c)(2) above. (ii) Error correction training is required to cover only the subject matter area(s) in which the error that caused the test to be cancelled occurred. (iii) As part of the error correction training, you must demonstrate your proficiency in the collection procedures of this part by completing three consecutive error-free mock collections. The mock collections must include one uneventful scenario and two scenarios related to the area(s) in which your error(s) occurred. The person providing the training must monitor and evaluate your performance and attest in writing that the mock collections were “error-free.” (g) Documentation. You must maintain documentation showing that you currently meet all requirements of this section. You must provide this documentation on request to DOT agency representatives and to employers and C/TPAs who are using or negotiating to use your services. Office of Drug and Alcohol Policy and Compliance Revised December 2006 ADD-31 DOT Urine Specimen Collection Guidelines 32 APPENDIX C – QUESTIONS AND ANSWERS Periodically, DOT will publish questions and answers specific to the collector and the collection process. These will be posted on the DOT Internet web site (www.dot.gov/ost/dapc/). All collectors are encouraged to check the site to ensure that they have the most current information to help them conduct DOT-required specimen collections appropriately. Collectors who do not have access to the Internet may obtain copies of the questions and answers from a fax-on- demand system by calling 1-(800)-225-3784. Collectors who do not have access to the Internet may obtain copies of the Questions and Answers from a fax-on-demand system by calling 1- (800)-225-3784. APPENDIX D – OPERATING ADMINISTRATIONS’ RULES (SUMMARY) 49 CFR Part 40 (40.33(a)) states that collectors must be knowledgeable about the DOT agency regulations applicable to the employers for whom the collectors conduct urine specimen collections. The following is a list of regulations which govern an employer’s implementation of the DOT drug and alcohol testing rules: The FMCSA regulation is 49 CFR Part 382. The FRA regulation is 49 CFR Part 219. The FAA regulation is 14 CFR Part 121. The FTA regulation is 49 CFR Part 655. The PHMSA regulation is 49 CFR Part 199. The USCG regulation is 46 CFR Parts 4, 5, and 16. Drug and alcohol testing (including SAP) procedures are 49 CFR Part 40. The following pages contain a short summary of some of the operating administrations’ requirements. Copies of the complete rule texts are available on the DOT Internet web site (www.dot.gov/ost/dapc/). Office of Drug and Alcohol Policy and Compliance Revised December 2006 ADD-32 DOT Urine Specimen Collection Guidelines 33 Federal Motor Carrier Safety Administration (FMCSA) Covered employee: A person who operates (i.e., drives) a Commercial Motor Vehicle(CMV) with a gross vehicle weight rating (gvwr) of 26,001 or more pounds; or is designed to transport 16 or more occupants (to include the driver); or is of any size and is used in the transport of hazardous materials that require the vehicle to be placarded. Types of tests for drugs: Pre-employment, random, reasonable suspicion, post-accident, return- to-duty, and follow-up. Types of tests for alcohol: Pre-employment (optional), random, reasonable suspicion, post- accident, return-to-duty, and follow-up. Definition of accident requiring testing: Any accident involving a fatality requires testing. Testing is also required in accidents in which one or more motor vehicles are towed from the scene or in which someone is treated medically away from the scene; and a citation is issued to the CMV driver. Reasonable-suspicion determination: One trained supervisor or company official can make the decision based upon specific, contemporaneous, articulable observations concerning the appearance, behavior, speech, or body odors of the employee. Pre-duty alcohol use prohibitions: Four (4) hours prior to performance of duty. Actions for BACs 0.02 – 0.039: The employee cannot be returned to duty until the next day or the start of the employee’s next regularly scheduled duty period, but not less than 24 hours following the test. Employee training: Employer must provide educational materials explaining drug and alcohol regulatory requirements and employer’s policies and procedures for meeting regulation requirements. Distribution to each employee of these educational materials and the employer’s policy regarding the use of drugs and alcohol is mandatory. Supervisor training: One-hour of training is required on the specific, contemporaneous physical, behavioral, and performance indicators of probable drug use. One-hour of training is also required on the specific, contemporaneous physical, behavioral, and performance indicators of probable alcohol use. Reportable employee drug and alcohol violations: No requirements to report violations to FMCSA. Other: Drivers are prohibited from using alcohol for eight hours following an accident (as described above) or until they have undergone a post-accident alcohol test, whichever occurs first. Office of Drug and Alcohol Policy and Compliance Revised December 2006 ADD-33 DOT Urine Specimen Collection Guidelines 34 Federal Railroad Administration (FRA) Covered employee: A person who performs hours of service functions at a rate sufficient to be placed into the railroad’s random testing program. Categories of personnel who normally perform these functions are locomotive engineers, trainmen, conductors, switchmen, locomotive hostlers/helpers, utility employees, signalmen, operators, and train dispatchers. Types of tests for drugs: Pre-employment, random, reasonable suspicion, reasonable cause, post-accident, return-to-duty, and follow-up. Types of tests for alcohol: Pre-employment (optional), random, reasonable suspicion, reasonable cause, post-accident, return-to-duty, and follow-up. Definition of accident requiring testing: FRA’s post-accident testing rule requires urine and blood specimen collection from surviving employees and also tissue from deceased employees (these collection procedures go well beyond the normal Part 40 procedures). For surviving employees, these specimens are collected at an independent medical facility. FRA regulation, 49 CFR Part 219 Subpart C, stipulates the level of events requiring testing and who has to be tested. The collected specimens are analyzed only at FRA’s contract laboratory. Post-accident testing provides FRA with accident investigation and usage data. Reasonable-suspicion determination: One trained supervisor can make the decision for alcohol testing based upon specific, contemporaneous, articulable observations concerning the appearance, behavior, speech, or body odors of the employee. A decision to conduct a drug test requires two supervisors (only the on-site supervisor must be trained). Reasonable-cause determination: Employers are authorized to use federal authority to test covered employees after specific operating rule violations or accidents/incidents which meet the criteria in 49 CFR Part 219 Subpart D. Pre-duty alcohol use prohibitions: Four (4) hours prior to performance of duty or after receiving notice to report for covered service, whichever is the shorter period. Actions for BACs 0.02 – 0.039: The employee cannot be returned to duty until the start of the employee’s next regularly scheduled duty period, but not less than 8 hours following the test. Railroads are prohibited from taking further disciplinary action under their own authority. Employee training: Employer must provide education materials that explain the requirements of the FRA rules as well as railroad policies and procedures with respect to meeting these requirements. Supervisor training: A total of three hours of training is required: one-hour on the specific, contemporaneous physical, behavioral, and performance indicators of probable drug use; one- hour of similar training on probable indicators of alcohol use; and one-hour of training on how to determine if an accident qualifies for post-accident testing. Office of Drug and Alcohol Policy and Compliance Revised December 2006 ADD-34 DOT Urine Specimen Collection Guidelines 35 FRA (continued) Reportable employee drug and alcohol violations: No requirements to report violations to FRA. Engineers, who are the only certificate holders in the rail industry, will have their certificates reviewed for suspension or revocation by the employer when a FRA violation occurs. Note that a FRA alcohol violation occurs at 0.04 percent or greater. When a locomotive engineer is in a voluntary referral program, the counseling professional must report the engineer’s refusal to cooperate in the recommended course of counseling or treatment. Other: Anyone with direct or immediate supervisory authority over an employee may not collect that person’s urine, saliva, or breath. Refusal to test results in a mandatory minimum nine-month removal from covered service. During this nine-month period, there is no prohibition against the employee working a non- covered service position if agreeable to the employer. Locomotive engineers (or other employees certified as a locomotive engineer at the time of the alcohol or drug violation) required both alcohol and drug return-to-duty tests; and both alcohol and drug follow-up tests. Locomotive engineers who have a DUI are required by Part 240 to be evaluated to determine whether they have an active substance abuse disorder. A DUI is not considered to be a violation of FRA regulations if it occurred during the employee’s off-duty time; therefore, any testing would be conducted under employer authority. Employers must provide a voluntary referral program which allows an employee to self-refer for treatment, and a co-worker report program which allows one employee to refer another for treatment before the employer identifies a problem. Both of these employee assistance programs guarantee that employees will retain their jobs if they cooperate and complete the required rehabilitation program. For an engineer who is in a voluntary referral program, the counseling professional must report the engineer’s refusal to cooperate in the recommended course of counseling or treatment to the employer. Office of Drug and Alcohol Policy and Compliance Revised December 2006 ADD-35 DOT Urine Specimen Collection Guidelines 36 Federal Aviation Administration (FAA) Covered employee: A person who performs flight crewmember duties, flight attendant duties, flight instruction duties, aircraft dispatch duties, aircraft maintenance or preventive maintenance duties; ground security coordinator duties; aviation screening duties; and air traffic control duties. Note: Anyone who performs the above duties directly or by contract for part 121 or 135 certificate holders, sightseeing operations as defined in 135.1(c), and air traffic control facilities not operated by the Government are considered covered employees. Types of tests for drugs: Pre-employment, random, reasonable cause, post-accident, return to duty, and follow-up. Types of tests for alcohol: Pre-employment (optional), random, reasonable suspicion, post- accident, return to duty, and follow-up. Definition of accident requiring testing: Accident means an occurrence associated with the operation of an aircraft which takes place between the time any person boards the aircraft with the intention of flight and all such persons have disembarked, and in which any person suffers death or serious injury, or in which the aircraft receives substantial damage. Testing must occur if employee's performance either contributed to the accident or cannot be completely discounted as a contributing factor of the accident. The decision not to test an employee must be based on a determination, using the best information available at the time of the determination, that the employee's performance could not have contributed to the accident. Reasonable cause determination (drugs): Two of the employee's supervisors, one of whom is trained, shall substantiate and concur in the decision to test the employee. If the employer is not an air carrier operating under 14 CFR part 121 and has 50 or fewer employees, a single trained supervisor can make the determination. A trained supervisor makes the determination based upon specific contemporaneous physical, behavioral or performance indicators of probable drug use. Reasonable suspicion determination (alcohol): One trained supervisor makes the determination based upon specific, contemporaneous, articulable observations concerning the employee's appearance, behavior, speech, or body orders. Pre-duty alcohol use prohibitions: Eight (8) hours prior to performance of flight crewmember duties, flight attendant duties, and air traffic controller duties. Four (4) hours prior to performance of other duties. Actions for BACs 0.02 - 0.039: If the employer chooses to return the employee to covered services within 8 hours, the BAC retest must be below 0.02. Employee training (drugs): An employer must train all employees who perform safety- sensitive duties on the effects and consequences of prohibited drug use on personal health, safety, and work environment, and on the manifestations and behavioral cues that Office of Drug and Alcohol Policy and Compliance Revised December 2006 ADD-36 DOT Urine Specimen Collection Guidelines 37 FAA (continued) may indicate drug use and abuse. Employers must also implement an education program for safety-sensitive employees by displaying and distributing informational materials, a community service hot-line telephone number for employee assistance and the employer's policy regarding drug use in the work place which must include information regarding the consequences under the rule of using drugs while performing safety-sensitive functions, receiving a verified positive drug test result, or refusing to submit to a drug test required under the rule. Employee training (alcohol): Employers must provide covered employees with educational materials that explain the alcohol misuse requirements and the employer's policies and procedures with respect to meeting those requirements. The information must be distributed to each covered employees and must include such information as the effects of alcohol misuse on an individual's health work, personal life, signs and symptoms of an alcohol problem; and the consequences for covered employees found to have violated the regulatory prohibitions. Supervisor training (drugs): One-hour of training is required on the specific, contemporaneous physical, behavioral, and performance indicators of probable drug use. In addition, supervisors must receive employee training as defined above. Reasonable recurrent training is also required. Supervisor training (alcohol): One-hour of training is required on the physical, behavioral, speech, and performance indicators of probable alcohol misuse. Reportable employee drug and alcohol violations: Each employer must notify the FAA about any covered employee who holds a certificate issued under 14 CFR Parts 61 (pilots and flight and ground instructors), 63 (flight engineers and navigators), or 65 (air traffic control tower operators, aircraft dispatchers, airframe or power plant mechanics, and repairmen) who has refused to take a drug or alcohol test. The MRO may report a positive or refusal (i.e. adulterated, substituted results or no medical explanation for providing an insufficient specimen) on behalf of the employer. Each employer must notify the FAA about any safety-sensitive employee who is required to hold an airman medical certificate issued under 14 CFR Part 67 who has a positive drug test result, an alcohol test result of 0.04 or greater, or who has refused to submit to testing. The MRO may report a positive or refusal (i.e. adulterated, substituted results or no medical explanation for providing an insufficient specimen) on behalf of the employer. Each employer must not permit an employee who is required to hold a medical certificate under part 67 to perform a safety-sensitive function to resume that duty until the employee has received a new medical certificate issued by the FAA Federal Air Surgeon and the employer has ensured that the employee meets the return to duty requirements of Part 40. (Medical certificates are not operating certificates but employees cannot continue to perform airman duties without a medical certificate.) Office of Drug and Alcohol Policy and Compliance Revised December 2006 ADD-37 DOT Urine Specimen Collection Guidelines 38 FAA (continued) According to FAA’s regulation 14 CFR part 121 Appendix I, Section VII.C.1 & 2, when a MRO verifies a drug test result or a SAP performs the initial evaluation, they must ask the employee whether he or she holds or would be required to hold an airman medical certificate issued under 14 CFR part 67 of this chapter to perform a safety-sensitive function for the employer. [This requirement only applies to MROs and SAPs who provide services for FAA regulated employers.] If the employee answers in the affirmative, the employee must obtain an airman medical certificate issued by the Federal Air Surgeon dated after the drug and/or alcohol violation date. The SAP must wait until the employee obtains their airman medical certificate before reporting to an employer that the employee demonstrated successful compliance with the SAP's treatment and/or education recommendations. Office of Drug and Alcohol Policy and Compliance Revised December 2006 ADD-38 DOT Urine Specimen Collection Guidelines 39 Federal Transit Administration (FTA) Covered employee: A person who performs a revenue vehicle operation; revenue vehicle and equipment maintenance; revenue vehicle control or dispatch (optional); Commercial Drivers License non-revenue vehicle operation; or armed security duties. Types of tests for drugs: Pre-employment, random, reasonable suspicion, post-accident, return- to-duty, and follow-up. Types of tests for alcohol: Pre-employment (optional), random, reasonable suspicion, post- accident, return-to-duty, and follow-up. Definition of accident requiring testing: Any accident involving a fatality requires testing. Testing following a non-fatal accident is discretionary: If the employer can show the employee’s performance could not have contributed to the accident, no test is needed. Non-fatal accidents that may require testing must have disabling damage to any vehicle or immediate medical attention away from the scene to meet the testing threshold. Reasonable-suspicion determination: One trained supervisor or company official can make the decision based upon specific, contemporaneous, articulable observations concerning the appearance, behavior, speech, or body odors of the employee. Pre-duty alcohol use prohibitions: Four (4) hours prior to performance of duty. Actions for BACs 0.02 – 0.039: If the employer chooses to return the employee to covered service within 8 hours, the BAC re-test must be below 0.02. Employee training: Employer must provide education with display and distribution of informational materials and a community service hot-line telephone number, if available. One-hour of training on the effects and consequence of prohibited drug use on personal health, safety, and the work environment, and on the signs and symptoms that may indicate prohibited drug use. Distribution to each employee of the employer’s policy regarding the use of drugs and alcohol with signed receipt is mandatory. Supervisor training: One-hour of training is required on the specific, contemporaneous physical, behavioral, and performance indicators of probable drug use. One-hour of training is also required on the specific, contemporaneous physical, behavioral, and performance indicators of probable alcohol use. Reportable employee drug and alcohol violations: No requirements to report violations to FTA. Other: Anyone with direct or immediate supervisory authority over an employee may not collect that person’s urine, saliva, or breath. Office of Drug and Alcohol Policy and Compliance Revised December 2006 ADD-39 DOT Urine Specimen Collection Guidelines 40 Pipeline and Hazardous Materials Safety Administration (PHMSA) Covered employee: A person who performs on a pipeline or liquefied natural gas (LNG) facility an operation, maintenance, or emergency-response function. Types of tests for drugs: Pre-employment, random, reasonable cause, post-accident, return-to- duty, and follow-up. Types of tests for alcohol: Post-accident, reasonable suspicion, return-to-duty, and follow-up. Definition of accident requiring testing: An accident is one involving gas pipeline facilities or LNG facilities or involving hazardous liquid or carbon dioxide pipeline facilities. Reasonable-suspicion determination: One trained supervisor can make the decision based upon signs and symptoms. Reasonable-cause determination: One trained supervisor can make the decision based upon reasonable and articulable belief that the employee is using prohibited drugs on the basis of specific, contemporaneous physical, behavioral, or performance indicators of probable drug use. Pre-duty alcohol use prohibitions: Four (4) hours prior to performance of duty. Actions for BACs 0.02 – 0.039: If the employer chooses to return the employee to covered service within 8 hours, the BAC retest must be below 0.02. Employee training (Drugs): Employer must provide EAP education with display and distribution of informational materials; display and distribution of a community service hot-line telephone number; and display and distribution of the employer’s policy regarding the use of prohibited drugs. Employee Training (Alcohol): Employer must develop materials that explain policies and procedures (as well as names of those who can answer questions about the program) and distribute them to each covered employee. Supervisor training: One-hour of training is required on the specific, contemporaneous physical, behavioral, and performance indicators of probable drug use. One-hour of training is also required on the specific, contemporaneous physical, behavioral, and performance indicators of probable alcohol use. Reportable employee drug and alcohol violations: No requirements to report violations to PHMSA. Office of Drug and Alcohol Policy and Compliance Revised December 2006 ADD-40 DOT Urine Specimen Collection Guidelines 41 United States Coast Guard (USCG) Covered employee: A person who is on board a vessel acting under the authority of a license, certificate of registry, or merchant mariner's document. Also, a person engaged or employed on board a U.S. owned vessel and such vessel is required to engage, employ or be operated by a person holding a license, certificate of registry, or merchant mariner's document. Types of tests for drugs: Pre-employment, periodic, random, reasonable cause, and post- serious marine incident (SMI), return-to-duty, and follow-up. Types of tests for alcohol: 49 CFR Part 40 alcohol-testing requirements do not apply to the Maritime Industry. 46 CFR Part 4.06 requires post-SMI chemical testing for alcohol use. 33 CFR Part 95.035 allows for a marine employer or a law enforcement officer to direct an individual to undergo a chemical test for intoxicants when reasonable cause exists or a marine casualty has occurred. Definition of incident requiring testing: An SMI is defined in 46 CFR 4.03-2. In general, an SMI is: A discharge of 10,000 gallons or more of oil into the navigable waters of the United States, whether or not resulting from a marine casualty; a discharge of a reportable quantity of a hazardous substance into the navigable waters or into the environment of the United States, whether or not resulting from a marine casualty; or a marine casualty or accident required to be reported to the Coast Guard, involving a vessel in commercial service, and resulting in any of the following: One or more deaths; an injury to any person (including passengers) which requires professional medical treatment beyond first aid, and, in the case of a person employed on board a commercial vessel, which renders the person unable to perform routine vessel duties; damage to property in excess of $100,000; actual or constructive total loss of any inspected vessel; or actual or constructive total loss of any uninspected, self-propelled vessel of 100 gross tons or more. Reasonable-cause determination (drugs): The marine employer must have a reasonable and articulable belief that the individual has used a dangerous drug. This belief should be based on the direct observation of specific, contemporaneous physical, behavioral, or performance indicators of probable use and where practicable based on the observation of two persons in supervisory positions. Reasonable-cause determination (alcohol): The employee was directly involved in the occurrence of a marine casualty or the individual operated a vessel and the effect of the intoxicant(s) consumed by the individual on the person's manner, disposition, speech, muscular movement, general appearance or behavior is apparent by observation. Pre-duty alcohol use prohibitions: Four (4) hours prior to performance of scheduled duty. Office of Drug and Alcohol Policy and Compliance Revised December 2006 ADD-41 DOT Urine Specimen Collection Guidelines 42 USCG (continued) Employee training: Employer must provide education with display and distribution of informational materials and a community service hot-line telephone number. Distribution to each employee of the employer’s policy regarding the use of drugs and alcohol is mandatory. Training must include the effects of drugs and alcohol on personal heath, safety, and work environment; and manifestations and behavioral cues that may indicate drug and alcohol use and abuse. Supervisor training: One-hour of training is required on the effects of drugs and alcohol on personal heath, safety, and work environment; and manifestations and behavioral cues that may indicate drug and alcohol use and abuse. Reportable employee drug and alcohol violations: Results of all post-SMI tests and positive drug test results for all mariners who hold a license, certificate of registry or merchant mariner's document must be reported to the nearest Coast Guard Officer in Charge, Marine Inspection. Office of Drug and Alcohol Policy and Compliance Revised December 2006 ADD-42