Magdalena Garcia,, et al., Respondents,v.New York City Department of Health and Mental Hygiene, et al., Appellants.BriefN.Y.April 26, 2018To be Argued by: AARON SIRI (Time Requested: 30 Minutes) APL-2017-00023 New York County Clerk’s Index No. 161484/15 Court of Appeals of the State of New York MAGDALENA GARCIA, individually and on behalf of her minor child PS, CLEMENCE RASIGNI, individually and on behalf of her minor child NR, LYNN ROSENGER, individually and on behalf of her minor children MR and RR, MICHELLE CARROLL, individually and on behalf of her minor child EP, and GABRIELLE JAKOB, individually and on behalf of her minor children AG and DG, Plaintiffs-Petitioners/Respondents, – against – THE NEW YORK CITY DEPARTMENT OF HEALTH AND MENTAL HYGIENE, THE NEW YORK CITY BOARD OF HEALTH and DR. MARY TRAVIS BASSET, in her Official Capacity as Commissioner of the New York City Department of Health and Mental Hygiene, Defendants-Respondents/Appellants. BRIEF FOR RESPONDENTS SIRI & GLIMSTAD LLP Pro Bono Attorneys for Respondents 200 Park Avenue, 17th Floor New York, New York 10166 Tel.: (212) 532-1091 Fax: (646) 417-5967 ii TABLE OF CONTENTS PRELIMINARY STATEMENT ............................................................................... 1 QUESTIONS PRESENTED ...................................................................................... 5 BACKGROUND ....................................................................................................... 6 1. The Legislature Has Exercised Control Over Mandatory School Vaccination by Enacting a Comprehensive Statutory Structure .......... 6 2. The Legislature Has Carefully Controlled the Scope of PHL Section 2164 ...........................................................................................11 3. The Legislature Expressly Rejected Requiring Mandatory Flu Vaccinations for Children .........................................................................12 4. Appellants Ignore Legislative Guidance and Adopt the Flu Shot Rule .........13 5. The Safety and Efficacy of the Flu Shot is Irrelevant ....................................15 6. Respondents Were Negatively Impacted by the Flu Shot Rule ......................17 7. Status of the Case ............................................................................................18 ARGUMENT ...........................................................................................................19 I. THE SUPREME COURT CORRECTLY HELD THAT THE RULE IS INVALID BECAUSE IT IS PREEMPTED BY STATE LAW.....................19 A. The Legislature has Preempted the Field of Mandatory Vaccinations for School Entrance ............................................................20 i. The Legislature’s Comprehensive Statutory and Regulatory Structure Establishes its Intent to Occupy the Entire Field of Mandatory School Vaccinations. ....................................................21 ii. The Legislature Declared its Policy to Occupy the Field of Mandatory School Vaccinations. ........................................................24 iii iii. The First Department Failed to Find Field Preemption Because it Improperly Defined the Field too Broadly and Declared the PHL to be a Floor to be Regulated Above ...................................................27 B. The Flu Shot Rule Directly Conflicts with the Policy Established by the Legislature .....................................................................................30 C. Charter Section 558 and Admin. Code Section 17-109 do Not Grant Appellants Authority to Require Mandatory School Vaccinations..........34 D. Appellants’ Arguments Regarding the BOH’s Authority are Not Availing .............................................................................................38 II. THE FIRST DEPARTMENT CORRECTLY HELD THAT THE FLU SHOT RULE IS INVALID BECAUSE APPELLANTS EXCEEDED THE BOUNDS OF THEIR LEGISLATIVE AUTHORITY .........................42 A. First Boreali Factor – The BOH Chose Between Policy Ends ................45 B. Second Boreali Factor – The BOH did Not Merely Fill in Details .........49 C. Third Boreali Factor – The BOH Acted in an Area in Which the Legislature Not Only Tried to Reach Agreement, It Reached Agreement ..................................................................................52 D. Fourth Boreali Factor - No Technical Competence Required for the Flu Shot Rule ......................................................................................55 E. Appellants’ Arguments that the Boreali Framework Should Not Apply, or that the First Department Applied it too Rigidly are Unavailing...........................................................................................56 CONCLUSION ........................................................................................................59 iv TABLE OF AUTHORITIES CASES Ahmed v. City of New York, 129 A.D.3d 435 (1st Dep’t 2015) .........................................................................52 Albany Area Builders Ass’n v. Town of Guilderland, 74 N.Y.2d 372 (1989) .............................................................................. 19, 20, 29 Alweis v. Evans, 69 N.Y.2d 199 (1987) ...........................................................................................41 Anonymous v. City of Rochester, 13 N.Y.3d 35 (2009) .............................................................................................31 Ardizzone v. Elliott, 75 N.Y.2d 150 (1989) .................................................................................... 20, 25 Baldwin Union Free Sch. Dist. v. Cty. of Nassau, 22 N.Y.3d 606 (2014) ...........................................................................................37 Boreali v. Axelrod, 71 N.Y.2d 1 (1987) ....................................................................................... passim Bri-Mar Corp. v. Town of Knox, 74 N.Y.2d 826 (1989) ...........................................................................................28 Broidrick v. Lindsay, 39 N.Y.2d 641 (1976) ...........................................................................................44 Bruesewitz v. Wyeth LLC, 562 U.S. 223 (2011) ..............................................................................................16 Chwick v. Mulvey, 81 A.D.3d 161 (2nd Dep't 2010) ..........................................................................24 Cohen v. Bd. of Appeals of Vill. of Saddle Rock, 100 N.Y.2d 395 (2003) .........................................................................................29 Consol. Edison Co. of N.Y. v. Town of Red Hook, 60 N.Y.2d 99 (1983) .......................................................................... 20, 21, 25, 34 Consol. Edison Co. of New York v. Dep’t of Envtl. Conservation, 71 N.Y.2d 186 (1988) .................................................................................... 40, 41 v Dandomar Co., LLC v. Town of Pleasant Valley Town Bd., 924 N.Y.S.2d 499 (2d Dep't 2011) .......................................................................37 Dutchess County Dept. of Soc. Services v. Day, 96 N.Y.2d 149 (2001) ...........................................................................................36 Greater N.Y. Taxi Assn. v New York City Taxi & Limousine Commn., 25 N.Y.3d 600 (2015) ...........................................................................................43 Lansdown Entm’t Corp. v. N.Y. City Dep’t of Consumer Affairs, 74 N.Y.2d 761 (1989) .................................................................................... 30, 31 Matter of Ahmed v City of New York, 129 A.D.3d 435 (1st Dep’t 2015) .........................................................................46 Matter of Citizens for Orderly Energy Policy, Inc. v. Cuomo, 78 N.Y.2d 398 (1991) ...........................................................................................58 New York State Health Facilities Association, Inc. v. Axelrod, 77 N.Y.2d 340 (1991) ...........................................................................................58 New York Statewide Coal. of Hispanic Chambers of Commerce v. New York City Dep't of Health & Mental Hygiene, 110 A.D.3d 1 (1st Dep’t 2013) ...................................................................... 45, 57 New York Statewide Coal. of Hispanic Chambers of Commerce v. New York City Dep’t of Health & Mental Hygiene, 23 N.Y.3d 681 (2014) ................................................................................... passim NYC C.L.A.S.H., Inc. v. New York State Office of Parks, Recreation & Historic Pres., 27 N.Y.3d 174 (2016) ...........................................................................................32 People ex rel. Spitzer v. Grasso, 11 N.Y.3d 64 (2008) .............................................................................................44 People ex rel. Spitzer v. Grasso, 42 A.D.3d 126 (1st Dep’t 2007) ...........................................................................44 People v. De Jesus, 54 N.Y.2d 465 (1981) .................................................................................... 21, 30 People v. Diack, 24 N.Y.3d 674 (2015) .................................................................................... 20, 21 vi Phillips v. City of New York, 775 F.3d 538 (2d Cir. 2015) .................................................................................23 Robin v. Inc. Village of Hempstead, 30 N.Y.2d 347 (1972) .................................................................................... 25, 37 S. H. Kress & Co. v. Dep't of Health of City of New York, 283 N.Y. 55 (1940) ....................................................................................... passim Subcontractors Trade Ass’n v. Koch, 62 N.Y.2d 422 (1984) ...........................................................................................44 Sunrise Check Cashing and Payroll Services, Inc. v. Town of Hempstead, 933 N.Y.S.2d 388 (2d Dep't 2011) ................................................................ 30, 31 Superintendent Ass’n of Rockland, Inc. v. Town of Clarkstown, 54 N.Y.S.3d 60 (2d Dep't 2017) ...........................................................................33 Wager v. Pelham Union Free Sch. Dist., 966 N.Y.S.2d 126 (2d Dep't 2013) .......................................................................36 Witty v. Delta Air Lines, Inc., 366 F.3d 380 (5th Cir. 2004) ................................................................................28 STATUTES AND REGULATIONS 10 NYCRR 40-2.23..................................................................................................10 42 U.S.C. § 300aa-15 ...............................................................................................16 L. 1901, ch. 46 .........................................................................................................35 L. 2004 ch. 207 ........................................................................................................38 L. 2006, ch. 189 .......................................................................................................12 L. 2006, ch. 266 .......................................................................................................55 L. 2009, ch. 282 .......................................................................................................54 L. 2010, ch. 36 ...................................................................................... 12, 13, 32, 54 L. 2013, ch. 56 .....................................................................................................9, 38 N.Y. Educ. L. § 310 .............................................................................................8, 33 N.Y. Educ. L. § 914 .............................................................................................8, 10 N.Y. Pub. Health L. § 206 ............................................................................ 9, 18, 24 vii N.Y. Pub. Health L. § 225 .......................................................................................28 N.Y. Pub. Health L. § 308 .......................................................................................28 N.Y. Pub. Health L. § 312 ................................................................................ 11, 37 N.Y. Pub. Health L. § 545 .......................................................................................37 N.Y. Pub. Health L. § 613 ............................................................................... passim N.Y. Pub. Health L. § 1106 .............................................................................. 11, 37 N.Y. Pub. Health L. § 1309 .............................................................................. 11, 37 N.Y. Pub. Health L. § 1503 .............................................................................. 11, 37 N.Y. Pub. Health L. § 2110 .............................................................................. 11, 37 N.Y. Pub. Health L. § 2125 .............................................................................. 11, 37 N.Y. Pub. Health L. § 2146 .....................................................................................11 N.Y. Pub. Health L. § 2153 .............................................................................. 11, 37 N.Y. Pub. Health L. § 2164 ............................................................................. passim N.Y. Pub. Health L. § 2165 ............................................................................. passim N.Y. Pub. Health L. § 2168 .....................................................................................25 N.Y. Soc. Serv. L. § 390 ................................................................................... 40, 41 N.Y.C. Admin. Code § 17-109 ........................................................................ passim N.Y.C. Charter § 558 .................................................................................. 34, 39, 40 N.Y.C. Charter § 1041 .............................................................................................39 N.Y.C. Charter § 1043 .............................................................................................39 LEGISLATIVE BILLS Bill No. A00608 (2011) ...........................................................................................11 Bill No. A00775 (2009) ...........................................................................................12 Bill No. A00775A (2009) ........................................................................................12 Bill No. A00775B (2009) ........................................................................................12 Bill No. A00791C (2015) ........................................................................................11 Bill No. A03706 (2010) ...........................................................................................55 viii Bill No. A03911 (2009) ...........................................................................................54 Bill No. A03911A (2009) ........................................................................................54 Bill No. A04010 (2005) ...........................................................................................11 Bill No. A04421 (2013) ...........................................................................................11 Bill No. A04866 (1999) ...........................................................................................11 Bill No. A05311 (2007) ...........................................................................................11 Bill No. A05475 (2007) ...........................................................................................54 Bill No. A05475A (2008) ........................................................................................54 Bill No. A06008 (2009) ...........................................................................................11 Bill No. A08910 (2007) ...........................................................................................12 Bill No. A08910A (2007) ........................................................................................12 Bill No. A09211 (2013) ...........................................................................................11 Bill No. A09347 (2014) ...........................................................................................11 Bill No. A10313 (2010) ...........................................................................................11 Bill No. A10942 (2008) .............................................................................. 11, 32, 52 Bill No. A10942A (2008) ................................................................................. 11, 53 Bill No. A11526 (2008) ...........................................................................................55 Bill No. S00876 (2009) ............................................................................................54 Bill No. S00876A (2009) .........................................................................................54 Bill No. S02469 (1999) ............................................................................................11 Bill No. S04324A (2015) .........................................................................................11 Bill No. S04601 (2007) ............................................................................................54 Bill No. S04601A (2008) .........................................................................................54 Bill No. S05118 (2007) ............................................................................................12 Bill No. S07156 (2010) ............................................................................................11 Bill No. S07348 (2014) ............................................................................................11 Bill No. S07822 (2008) ............................................................................................11 Bill No. S08623 (2008) ............................................................................................11 ix OTHER AUTHORITIES 24A Carmody-Wait 2d § 145:687 ............................................................................33 1 PRELIMINARY STATEMENT In New York, every child enrolling in school must receive a series of mandatory vaccinations. The State Legislature statutorily established the list of mandatory vaccines in Public Health Law (“PHL”) Sections 2164 and 2165. In 2010, the Legislature considered and rejected the idea of adding the flu shot to this list. Instead, the Legislature directed the Commissioner of the State Department of Health (the “State Health Commissioner”) to create a program to educate people in the State about the danger of the flu and the benefits of the flu shot, but it prohibited mandating the flu shot without Legislative approval. Defendants-Respondents/Appellants (“Appellants”) disagreed with the Legislature’s decision. In 2013, they took it upon themselves to overrule the Legislature by adopting a new regulation requiring that children attending certain pre-schools in New York City (“NYC”) receive the flu shot every year (the “Flu Shot Rule” or “Rule”). However, as both the Supreme Court and the First Department found in this case, Appellants lacked the authority to enact this Rule. First, the Flu Shot Rule is preempted by State law. The Legislature created a comprehensive and detailed statutory scheme governing all aspects of mandatory school vaccinations. This includes directing which vaccines children must receive at certain ages, creating a system to administer and pay for those vaccinations, controlling how individual schools respond to parents or students who lack the 2 required vaccinations, precluding students without the required vaccinations from attending school, and establishing an appellate procedure through the State Department of Education for when parents or students believe they were wrongfully denied access to a school. As part of this comprehensive scheme, the Legislature chose to centralize oversight of its mandatory school vaccination program at the State level. The State Health Commissioner has sole authority to create regulations implementing the mandatory school vaccination program. All municipal health organizations, including Appellants, must create and submit to the State Health Commissioner plans for implementing the school vaccination program and report on how well their efforts have succeeded. Furthermore, the Legislature explicitly reserved for itself the right to amend the list of mandatory vaccinations required for school. By enacting this comprehensive statutory scheme and expressing a policy of centralized oversight, the Legislature implicitly demonstrated an intent to preempt the field of mandatory school vaccinations. Therefore, the Flu Shot Rule cannot stand because Appellants lacked the authority to act in that field. (Infra § I(A).) The Flu Shot Rule also directly conflicted with the Legislature’s established policy concerning the flu shot. The Legislature chose to encourage and educate the public about the flu shot, but not to mandate it. In fact, the Legislature explicitly directed the Appellants to assist the State Health Commissioner’s efforts to educate 3 the public but prohibited them from mandating the flu shot without Legislative approval. When Appellants adopted the Flu Shot Rule, they ignored this policy and thereby created a conflict between State law and Appellants’ Rule. When a local agency’s regulation conflicts with State law, the local regulation must give way. As such, the conflicts between the State law and the Flu Shot Rule require the latter to be declared invalid. (Infra § I(B).) Second, Appellants lacked authority to enact the Flu Shot Rule because, in doing so Appellants engaged in making public policy decisions in violation of the role preserved in the State Constitution for the Legislature. This Court established a four-part framework in Boreali v. Axelrod, 71 N.Y.2d 1 (1987) (“Boreali”) for analyzing when an agency oversteps its boundaries and intrudes into improper legislative activities. All four of the Boreali factors show that in adopting the Flu Shot Rule, Appellants improperly usurped the role of the Legislature. (Infra § II.) The first Boreali factor asks whether Appellants engaged in a balancing of competing concerns based on their own ideas of public policy. Appellants engaged in such an improper balancing by weighing non-health related economic factors when adopting the Flu Shot Rule. The Rule applies to less than 20% of the child care facilities in NYC, thereby placing economic burdens on a small fraction of these facilities, while leaving the remainder untouched. The Flu Shot Rule is also not mandatory, rather schools can make the economic decision to accept an 4 unvaccinated student and pay a fine. Appellants further adopted the Rule because they stated it would reduce the flu’s burden on the economy and increase worker productivity. Additionally, by adopting the Rule, Appellants took it upon themselves to choose between competing ends of requiring the flu shot, which impinges upon various rights (including bodily integrity, privacy, and parental choice), versus encouraging the flu shot, which does not impinge upon those rights. The foregoing exceptions and policy choices are for the Legislature to craft and decide, not Appellants. The second Boreali factor examines whether Appellants drafted the Rule on a clean slate, acting without any policy guidance from the Legislature. Here Appellants lacked such policy guidance. Appellants claim that NYC Administrative Code Section 17-109 provided authority to adopt the Rule, but that 100-year-old Section makes no mention of schools or the authority to mandate vaccinations for school admission. Any authority granted in that section must yield to the Legislature’s more recent and more specific statutes concerning mandatory school vaccinations. The third Boreali factor asks if Appellants acted in an area where the Legislature has tried, but failed, to reach a decision concerning statewide policy. Here, far from acting in an area where the Legislature has failed to reach a consensus, 5 Appellants simply chose to ignore the Legislature’s decision to encourage but not mandate the flu shot. The fourth Boreali factor looks at whether Appellants went outside their expertise in public health in adopting the Rule. The decisions Appellants made here in adopting the Rule went well beyond their specific expertise. For example, Appellants chose to only apply the Rule to certain schools, to provide schools with an economic option to opt-out of the Rule, to weigh other economic factors, and to hear appeals themselves. None of these decisions involved health issues, but rather the weighing of general economic, education and public policy options. For these reasons, Plaintiffs-Petitioners/Respondents (“Respondents”) respectfully request that this Court affirm the determination by the Supreme Court and the First Department that the Rule is invalid. QUESTIONS PRESENTED 1. Should the Flu Shot Rule be declared invalid because the Legislature has preempted the field of mandatory school vaccinations by enacting a policy of centralized control over local vaccination programs and a comprehensive and detailed regulatory scheme covering mandatory school vaccinations? “Yes.” (Infra § I(A).) If “no”: 2. Should the Flu Shot Rule be declared invalid because it conflicts with the PHL by both prohibiting students from attending a school that State law permits 6 them to attend and creating a separate appellate review system that conflicts with the system established by State law, which can lead to contradictory results? “Yes.” (Infra § I(B).) If “no”: 3. Should the Flu Shot Rule be declared ultra vires because, applying the framework established in Boreali, it crosses beyond interstitial rulemaking and intrudes upon the legislative arena? “Yes.” (Infra § II.) BACKGROUND 1. The Legislature Has Exercised Control Over Mandatory School Vaccination by Enacting a Comprehensive Statutory Structure In New York, the PHL creates a structure that governs mandatory vaccinations for all children entering schools. Section 2164 of the PHL establishes the primary structure and requirements for schools to require certain vaccines as a prerequisite to admission. To ensure the broadest possible impact of this vaccination structure, Section 2164 expansively defines “school” to include “any public, private or parochial child caring center, day nursery, day care agency, nursery school, kindergarten, elementary, intermediate or secondary school.” PHL § 2164(1)(a). Likewise, it defines “child” to include “any person between the ages of two months and eighteen years” and parent to include “father or mother, by birth or adoption, his legally appointed guardian, or his custodian.” PHL § 2164(1)(b)-(c). Section 2165 7 of the PHL establishes similar broad definitions for the vaccinations necessary for students attending institutions of higher education in New York. With this broad definition in place, Paragraph 2(a) states in relevant part: Every person in parental relation to a child in this state shall have administered to such child an adequate dose or doses of an immunizing agent against poliomyelitis, mumps, measles, diphtheria, rubella, varicella, Haemophilus influenzae type b (Hib), pertussis, tetanus, pneumococcal disease, and hepatitis B[.] PHL § 2164(2)(a). Paragraphs 2(b) and 2(c) establish what additional vaccinations are required for entrance into sixth, seventh and twelfth grades. PHL § 2164(2)(b)- (c). Paragraph 4 provides that parents who cannot afford these mandatory vaccinations can obtain them from their county’s health officer free of charge. PHL § 2164(4). Paragraph 5 requires all health practitioners who administer the above mandatory vaccinations to give the child a “certificate of such immunization.” PHL § 2164(5). Paragraph 6 instructs “the principal, teacher, owner or person in charge of the school” how to respond if a child applies to a school without the necessary vaccination certificates. PHL § 2164(6). First, they are to “inform such person of the necessity to have the child immunized” and that the immunization can be obtained at no charge. Id. Next, if the parent refuses to consent to the vaccination, the school must provide a form to the parent. Id. The form notifies the parent that 8 the mandatory vaccinations are “a prerequisite to processing the application for admission.” Id. In response, the parent must state on the form “a valid reason for withholding consent.” Id. If a parent cannot provide a valid reason, then the parent “shall” consent for the “immunization to be administered by a health officer in the public employ, or by a school physician or nurse.” Id. Paragraphs 8 and 9 establish that the only “valid reasons” to withhold consent to vaccination are either a documented medical condition or “genuine and sincere religious beliefs” that prohibit such vaccination, and provide the standard for evaluating such claims. PHL § 2164(8), (9). If a parent continues to refuse the mandatory vaccinations, without a “valid reason” to do so, Paragraph 7 mandates that “[n]o principal, teacher, owner or person in charge of a school shall permit any child to be admitted to such school, or to attend such school, in excess of fourteen days, without the [vaccination] certificate.” PHL § 2164(7). See also N.Y. Educ. L. § 914. Paragraph 7 also provides that if a school denies a child admission due to a lack of vaccinations, the parent “may appeal by petition to the commissioner of education in accordance with the provisions of” Section 310 of the Education Law. PHL § 2164(7)(b); N.Y. Educ. L. § 310(6-a). Section 310 grants the commissioner of education broad review powers over many different issues pertaining to the State’s school system. 9 The Legislature placed control over this mandatory vaccination program within the ambit of the State Health Commissioner. To that end, it mandated that the Commissioner “shall develop and supervise the execution of a program of immunization, surveillance and testing, to raise to the highest reasonable level the immunity of the children of the state against communicable diseases.” PHL § 613(1)(a); see also PHL § 206(b), (l). This included the power to “set such standards as he shall deem necessary for the proper, safe, and efficient administration of the program” and to adopt regulations “to effectuate the provisions and purposes” of Section 2164. PHL §§ 613(2), 2164(10) . The Legislature recognized that municipal agencies have a role to play in vaccinating communities, but in 2013 it placed the municipalities’ vaccination programs under the State’s supervision. L. 2013, ch. 56, § 24 (Part E). The Legislature amended Section 613(1)(a) to state that municipalities “shall maintain local programs of immunization to raise the immunity of the children and adults of each municipality to the highest reasonable level.”1 Id. Those programs must be “approved by the commissioner.” PHL § 613(1)(a). As such, the Legislature chose to place local vaccination programs under the State Health Commissioner’s 1 Prior to the 2013 amendments, Section 613 had only obligated the State Health Commissioner to “encourage the municipalities in the state to develop and … assist them in the development and execution of local programs of inoculation ….” L. 2013, ch. 56, § 24 (Part E). 10 supervision. 10 NYCRR 40-2.23(a) (stating that local health department immunization programs must comply with PHL §§ 613, 2164, 2165 and 2168). The State’s control over local municipal programs is also clear from the Legislature’s mandate that, as part of its immunization programs, each municipality must annually submit to the State Health Commissioner a plan “for assuring that immunizing agents are administered to pre-school children … and to students generally, as required pursuant to” Section 2164. PHL § 613(2); N.Y. Educ. Law § 914(2). (See also R. 14.) It also required that “[e]very school shall annually provide the commissioner … a summary regarding compliance with the provisions of” Sections 2164 and 2165. PHL §§ 2164(11), 2165(10). The State Health Commissioner and the local municipal programs, however, do not have the authority to mandate vaccinations. The Legislature made clear that only it can change or amend the list of mandatory vaccinations. As part of the same subdivision of Section 613 where it granted the State Health Commissioner authority over the vaccination program and required municipalities to create local vaccination programs, it also stated that “[n]othing in this subdivision shall authorize mandatory immunization of adults or children, except as provided in” Sections 2164 and 2165. PHL § 613(1)(c). Unlike other sections of the PHL, nothing in the Legislature’s comprehensive scheme for mandatory school vaccination exempts NYC from Sections 613, 2164 11 and 2165. See, e.g., PHL §§ 312, 545, 1106, 1309, 1503, 2110, 2125, 2146, 2153 (each expressly exempting NYC from specific sections of the PHL). 2. The Legislature Has Carefully Controlled the Scope of PHL Section 2164 Since enacting Section 2164, the Legislature has been deliberative and careful to control the number and type of vaccines that it makes mandatory for attending school. For example, in 2015, the Legislature added the meningococcal vaccine after seven years of legislative process, including lengthy and contentious floor debates among its 213 elected members; this included committee hearings, compromise, constituent input and accountability, and all the other safeguards for passing legislation. See Bill Nos. A10942A (2008), S07822 (2008), S08623 (2008), S07156 (2010), A10313 (2010), A00608 (2011), A04421 (2013), A09211 (2013), A09347 (2014), S07348 (2014), A00791C (2015), S04324A (2015). Likewise, the Legislature has, often after similar debate, rejected numerous bills to mandate various other vaccines for school entry. See, e.g., Bill Nos. A4010 (2005), A05311 (2007), A06008 (2009) (rejecting requiring vaccination for hepatitis A); Bill Nos. A10942 (2008), A10942A (2008) (rejecting requiring vaccination for the flu and other CDC recommended vaccines); Bill Nos. A10942 (2008), S07822 (2008), S08623 (2008), S07156 (2010), A10313 (2010), A00608 (2011), A04421 (2013), A09211 (2013), A09347 (2014), S07348 (2014) (rejecting requiring vaccination for meningococcal); Bill Nos. S02469 (1999), A04866 (1999) (rejecting 12 requiring vaccination for rotavirus). In fact, other than the meningococcal vaccine, the last time the Legislature reached consensus to add a mandated vaccine to Section 2164 was in 2006 for pneumococcal. L. 2006, ch. 189. 3. The Legislature Expressly Rejected Requiring Mandatory Flu Vaccinations for Children In 2007, a bill was introduced in the Legislature regarding the flu shot whose official “Justification” was that in that same year the CDC “made changes to the [CDC’s] childhood immunization schedule that included recommendations that all children aged six months to fifty-nine months receive a yearly influenza vaccine.” Bill No. A08910 (2007); S5118 (2007). After being referred in and out of committee at least twelve times, being modified at least seven times, and voted upon by the full Assembly or Senate at least five times, including in 2007, 2008, 2009 and 2010, this bill finally passed both chambers in 2010. Bill Nos. A08910 (2007), S05118 (2007), A08910A (2007), S05118A (2007), S05118B (2007) A00775 (2009), S04645 (2009), A00775A (2009), S04645A (2009), A00775B (2010), S04645B (2010). The resulting legislation, entitled “Influenza Disease and Influenza Immunizations,” expressly chose not to mandate the flu shot for children. L. 2010, ch. 36. Instead, the legislation amended PHL § 613(1) to require the Commissioner of Health, along with Appellants, to “raise to the highest reasonable level the immunity of children of the state against … influenza” as well as “administer a program of influenza education to the families of children … who attend licensed 13 and registered day care programs,” including regarding “the benefits of influenza immunizations.” Id. The Legislature placed this policy directive regarding the flu shot in the same subdivision that provides that nothing therein authorized officials to require any immunization, except as provided in Sections 2164 and 2165. PHL § 613(1)(c). 4. Appellants Ignore Legislative Guidance and Adopt the Flu Shot Rule In 2013 then Mayor Bloomberg directed Appellants, i.e., the Commissioner of the NYC Department of Health and Mental Hygiene (the “City Health Commissioner”) and eleven appointees comprising the NYC Board of Health (“BOH”), which are part of the NYC Department of Health, to adopt a rule requiring certain children in certain preschools in NYC obtain a flu shot. Appellants’ justification for the Flu Shot Rule included the same 2007 CDC recommendation that the Legislature expressly considered when passing the flu shot amendment to PHL § 613 in 2010. Compare R. 73 with Bill No. A08910, “Justification.” But even though the Legislature made the policy choice to encourage and educate regarding the flu shot, and prohibited mandating the flu shot, Appellants made the opposite policy choice – to mandate the flu shot. Compare L. 2010, ch. 36 with R. 75, 77. 14 Appellants adopted the Flu Shot Rule on December 11, 2013, by creating Sections 43.17(a)(2) and 47.25(a)(2)2 of the NYC Health Code. (R. 75-78.) By adopting the Rule, Appellants added a new paragraph 2(B), which states in relevant part that “Children aged from 6 months to 59 months shall be immunized each year before December 31 against influenza with a vaccine[.]” (Id.) Rather than require students who lack the flu shot to be expelled, the Rule stated that, “the principal or person in charge of a school may after December 31 refuse to allow any child to attend such school without” the flu shot. (R. 75-78.) (emphasis added). If the child remains in the school, the school will be subject to a fine. (Id.) In doing so, Appellants chose to permit day care centers to opt to pay a fine instead of expelling a child and losing an entire year of tuition. (R. 51, 515-17.) In adopting the Rule, Appellants created an appeals process separate from the appellate process under Section 2164. The parent of a “child denied attendance by a principal or person in charge of a school” due to the Rule “may appeal by petition to the” City Health Commissioner. (R. 75-78.) Appellants’ Rule also only applies to a limited subset of child care providers in NYC; as the First Department explained: [T]he flu shot requirement applies only to the 2,283 larger licensed child care facilities in New York City that the Board regulates, and does not cover the 9,241 providers that fall under 2 The relevant portions of Sections 43.17 and 47.25 that address immunization are nearly identical. (R. 75-78.) 15 State regulations. Thus, less than 20% of child care facilities in the city must abide by the flu vaccine mandate. Further, the vaccine requirement does not apply to more than 20,000 legally exempt child care providers. (R. 513-514.) See also R. 10 (same). 5. The Safety and Efficacy of the Flu Shot is Irrelevant Appellants extensively discuss the issues of flu shot efficacy and safety. (R. 143-146, 152, 179-180; App. Br. at 14-15.) Whether the flu shot is effective, or safe, however, has no bearing on this case. The issue in this case is whether Appellants had the authority to adopt the Rule, not whether it was a good idea. As this Court explained in Boreali when striking down the smoking ban: [W]e stress that this case presents no question concerning the wisdom of the challenged regulations... The degree of scientific support for the regulations … are, likewise, not pertinent except as background information. … The only dispute is whether the challenged restrictions were properly adopted by an administrative agency… 71 N.Y.2d at 8-9 (emphasis added.) The same is true here. Even if the issue was relevant, the Record does not support Appellants’ claim that the efficacy and safety of the flu shot is beyond reproach. As for efficacy, according to the CDC, during the flu season of 2014-2015, the flu shot’s “overall VE [vaccine effectiveness] estimate was 19%”. (R. 469.) Hand washing was more 16 effective at preventing the flu. (R. 490) (“hand-sanitizing gel reduces absenteeism rates by 33-50 percent”).3 As for safety, Federal law provides vaccine makers immunity from liability for vaccine injuries because Congress determined that vaccines are “unavoidably unsafe.” Bruesewitz v. Wyeth LLC, 562 U.S. 223, 254-55 (2011). The Federal Vaccine Injury Compensation Program has paid over $2.1 billion for vaccine injury claims since 2006 (with a per case cap of $250,000 for death and pain/suffering), and the flu shot accounts for over 64% of those claims.4 42 U.S.C. § 300aa-15(a). The following is a partial list of reactions disclosed by manufacturers for pediatric flu shots: anaphylactic shock, arthralgia, asthma, bell’s palsy, brachial neuritis, death, facial palsy, facial paresis, febrile convulsions, guillain-barre syndrome, lymphadenopathy, meningitis, myasthenia, myelitis, neuritis, optic neuritis/neuropathy, paralysis, paresthesia, stevens-johnson syndrome (Manufacturer Inserts for Fluzone, FluMist, Fluvirin and Fluarix.)5 Nevertheless, as 3 Moreover, in 2012, the Cochrane Collaboration, whose partners/funders include the NIH, WHO, and Mayo Clinic, conducted a meta-review of 224 flu shot studies and found that “we could find no convincing evidence that [influenza] vaccines can reduce mortality, hospital admissions, serious complications or community transmission of influenza.” (R. 198.) 4 https://www.hrsa.gov/vaccinecompensation/data/vicpmonthlyreporttemplate8_1_17.pdf. Moreover, the CDC’s Vaccine Adverse Events Reporting System, to which “fewer than 1% of vaccine adverse events are reported,” has since 2006 received 152,738 reports involving the flu shot, including 37,424 emergency room visits, permanent disabilities and/or deaths. https://wonder.cdc.gov/vaers.html; https://healthit.ahrq.gov/sites/default/files/docs/publication/ r18hs017045-lazarus-final-report-2011.pdf 5 www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm093830.htm 17 noted above, whether the flu shot is safe and effective has no bearing on this case. 6. Respondents Were Negatively Impacted by the Flu Shot Rule Respondents are parents who come from diverse backgrounds and different parts of NYC. (R. 91-112.) They all provide and intend to continue providing their children with all vaccines required by State law. (Id.) These parents only object to giving their children the annual flu shot. (Id.) Most of the Respondents depend on childcare to work and further their careers while others depend on childcare to attend college. (R. 91-112.) Respondents’ children all attended, or planned to attend, a preschool covered under the Flu Shot Rule. (Id.) Despite their objections to the flu shot, they, like many other parents in NYC, were advised that their children would be expelled from preschool if they did not receive the flu shot on or before December 31, 2015.6 (Id.) Nevertheless, thousands of other parents in NYC were permitted to continue to send their children to preschool without a flu shot simply because they were in preschools that are not required to enforce the Rule. Because Appellants are an unelected board, Respondents could not hold their elected representatives accountable for having the Rule foisted upon them. (Id.) They could not refuse to reelect the individuals that created this requirement. (Id.) 6 Respondents’ children faced being expelled from preschools where they had thrived, received special services, and created bonds with their classmates, as well as developed their social, emotional, and basic building block skills. (R. 91-112.) 18 Respondents therefore each asked “that the Court will prohibit [Appellants] from enforcing their flu dictate and instead let this issue be addressed, as it should be, by my elected representatives to whom I have recourse and can hold accountable.” (Id.) 7. Status of the Case Respondents filed this case as a special proceeding seeking an injunction prohibiting Appellants from implementing and enforcing the Flu Shot Rule. (R. 10.) On December 16, 2015, the Supreme Court “permanently enjoin[ed Appellants] from implementing and enforcing the” Flu Shot Rule. (R. 8.) It held: Nothing within the … [PHL] allows the [State Health Commissioner] or municipalities to mandate vaccines that are not explicitly authorized under § 2164 and § 2165 absent New York State legislative amendments…. [Appellants’] reliance on § 17-109 is misplaced…. Assuming that the 150 year-old statute … [at some point] permitted [Appellants] to mandate new vaccines to effectively prevent the spread of communicable diseases, § 17-109 must yield to the more recent and more specific statutes - §§ 206, 613, 2164, and 2165 of the [PHL], which do not mandate the influenza vaccines …, or give [Appellants] the statutory authority to mandate new vaccines without prior enactments from the New York State legislature. (R. 13.) The Supreme Court found that its preemption ruling obviated the need to perform a Boreali analysis. (R. 14.) The First Department affirmed the Supreme Court’s order, though on different grounds. It rejected the preemption argument and instead found that Appellants 19 “exceeded the scope of [their] regulatory authority by adopting” the Rule. (R. 508- 510.) After discussing the Boreali framework, the First Department concluded that: by adopting the challenged amendments, the Board of Health “cross[ed] the line into legislative territory.” … The Boreali factors, when viewed together, support the conclusion that by adopting the challenged amendments … the Board of Health was making policy and impermissibly crossed into the legislative sphere. (R. 512, 517.) ARGUMENT I. THE SUPREME COURT CORRECTLY HELD THAT THE RULE IS INVALID BECAUSE IT IS PREEMPTED BY STATE LAW In their brief, Appellants assert that they adopted the Flu Shot Rule based on the authority awarded to the BOH over 100 years ago in NYC Administrative Code (“Admin. Code”) Section 17-109. That section, however, says nothing about the flu shot or mandatory vaccinations, nor does it grant the BOH any power to require mandatory school vaccinations. To the contrary, the Legislature has preempted local action regarding mandatory school vaccinations. “Preemption applies both in cases of express conflict between local and State law and in cases where the State has evidenced its intent to occupy the field.” Albany Area Builders Ass’n v. Town of Guilderland, 74 N.Y.2d 372, 377 (1989). Here the Legislature showed its intent to occupy the field of mandatory school vaccinations by passing and amending Sections 613, 2164 and 20 2165. (Infra § I(A).) Further, even if arguendo the Legislature has not evidenced an intent to occupy the entire field, the Flu Shot Rule directly conflicts with State law and therefore is invalid. (Infra § I(B).) A. The Legislature has Preempted the Field of Mandatory Vaccinations for School Entrance “[I]f the State has demonstrated an intent to preempt an entire field” it has thereby chosen to “preclude any further local regulation.” Ardizzone v. Elliott, 75 N.Y.2d 150, 155 (1989). “Where the State has preempted the field, a local law regulating the same subject matter is deemed inconsistent with the State’s transcendent interest, whether or not the terms of the local law actually conflict with a State-wide statute.” Albany Area Builders Ass’n, 74 N.Y.2d at 377. “Although field preemption may be ‘express’ as evidenced by the legislature’s stated directive, it may also ‘be implied from a declaration of State policy by the Legislature or from the fact that the Legislature has enacted a comprehensive and detailed regulatory scheme in a particular area.’” People v. Diack, 24 N.Y.3d 674, 679 (2015) (quoting Consol. Edison Co. of N.Y. v. Town of Red Hook, 60 N.Y.2d 99, 105 (1983)). Here both the comprehensive structure of the statutes (Infra § I(A)(i)) and the policy of centralizing oversight of the program (Infra § I(A)(ii)), establish that the Legislature’s “purpose and design is to preempt the subject of” mandatory school vaccinations. Id. at 680. As a result, Appellants lacked authority to adopt the Flu Shot Rule. 21 i. The Legislature’s Comprehensive Statutory and Regulatory Structure Establishes its Intent to Occupy the Entire Field of Mandatory School Vaccinations. The Legislature’s intent to preempt the field of mandatory school vaccinations is clear from the comprehensive and detailed nature of the regulatory scheme it created. See, e.g., Consol. Edison Co., 60 N.Y.2d at 106 (finding that the field of power plant generation was preempted because “the Legislature has enacted a comprehensive and detailed regulatory scheme”); People v. De Jesus, 54 N.Y.2d 465, 469 (1981) (ruling that the State Alcoholic Beverage Control Law preempted local action because “the regulatory system it installed is both comprehensive and detailed”). Sections 2164 and 21657 establish detailed rules and procedures for the mandatory school vaccination program. The broad scope of this scheme is evident in the very first paragraph of Section 2164, where it defines “school” as broadly as possible, and “child” as anyone between two months and 18 years old. These definitions show that the Legislature intended the mandatory school vaccination program to apply to every young person entering any school in the State. 7 Appellants argue Section 2165 is irrelevant because it concerns higher education. (App. Br. at 54 n.27.) However, Section 2165 is part of a comprehensive set of laws regulating mandatory school vaccinations, and therefore, helps establish the Legislature’s intent to preempt the entire field of mandatory school vaccinations. See Diack, 24 N.Y.3d at 682 (a section of the sex offenders law was relevant to the issue of field preemption, even though the defendant did not fall within the class of offenders subject to that section). 22 Thereafter, paragraph 2 sets forth a detailed list of which vaccinations every parent must ensure their child receives at multiple specific points during their primary and secondary education. PHL § 2164(2). Likewise, Section 2165 establishes the specific vaccinations required for entrance into any higher education setting. PHL § 2165(2). Only the Legislature can amend the list in Section 2164 and 2615 or require new “mandatory immunization of adults or children.” PHL § 613(1)(c). The Legislature then created a system to administer and pay for those vaccines. Sections 2164 and 2165 require a parent to present any unvaccinated child, or an unvaccinated adult student to present themselves, to a health practitioner and ask them “to administer the necessary immunization[s].” PHL §§ 2164(3), 2165(3). After the vaccination, the health practitioner must provide a certificate certifying immunization. PHL §§ 2164(5), 2165(5). To ensure no one remains unvaccinated due to cost, the statutes obligate local health officers to provide the vaccinations without charge, and establish a system for State funds to pay for the vaccinations. PHL §§ 613(3)(b), 2164(4), 2165(4) The Legislature also regulated how schools act, by establishing how they must respond when a student applies who lacks the required vaccination certifications. PHL §§ 2164(6), 2165(6). Schools must first state that the student can receive the necessary vaccinations from their own health practitioner or for free from the county 23 health officer. Id. If the parent or student still refuses to consent to the vaccinations, schools are required to give the parent or student a form, the contents of which are described in the statutes. Id. Upon receipt of the form, if the parent or student refuses vaccination he or she must give a valid reason to not be vaccinated. PHL §§ 2164(6), 2165(6). The statutes provide the only two valid reasons and the standard for judging each reason. PHL §§ 2164(8)-(9), 2165(8)-(9). If a parent or student refuses the vaccination, and lacks a valid reason for refusal, both Sections 2164 and 2165 require the school to deny admission. PHL §§ 2164(7)(a), 2165 (7). If this occurs, the school must inform the local health officer, who must arrange a time for administering the vaccine and if the officer fails to do so, the State Health Commissioner must arrange a time for administrating the vaccine. PHL § 2164(8-a). Section 2164 allows the parent or student to appeal a school’s decision to refuse admission directly to the State Commissioner of Education. PHL § 2164(7)(b); see also Phillips v. City of New York, 775 F.3d 538, 540 (2d Cir. 2015). Thus, the Legislature regulated every aspect of the mandatory school vaccination program, from what vaccines are required to attend school, to how to administer and pay for the vaccines, to how a school is to respond to an unvaccinated student, and how a student can appeal the school’s decisions. This comprehensive structure “leaves no room for local ordinances to operate. Instead, the State statutes 24 give localities[, individuals, and schools] detailed instructions concerning the procedures to be employed” thereby evidencing the intent to preempt the field of mandatory school vaccinations. Chwick v. Mulvey, 81 A.D.3d 161, 172 (2d Dep’t 2010). ii. The Legislature Declared its Policy to Occupy the Field of Mandatory School Vaccinations. In addition to a comprehensive statutory structure, “[a] desire to pre-empt may [also] be implied from a declaration of State policy by the Legislature.” Consol. Edison, 60 N.Y.2d at 105. Sections 613, 2164, and 2165 evidence a policy choice by the Legislature to centralize authority for the mandatory school vaccination program in the State Health Commissioner and the Legislature, thereby preempting the field. The Legislature invested the State Health Commissioner with broad authority to “develop and supervise the execution of” the state-wide childhood vaccination program. PHL §§ 613(1)(a), 206(b), (l). This included the exclusive authority to “adopt and amend rules and regulations to effectuate the provisions and purpose of” Sections 2164 and 2165. PHL §§ 2164(10), 2165(11). Likewise, the Legislature mandated that local childhood vaccination programs must be “approved by the commissioner[,]” obligated municipalities to submit a plan to the State Health Commissioner for administering the vaccines required by Section 2164, and required them to submit annual reports documenting the effectiveness of those programs. 25 PHL §§ 613(1)(b), (2) (tying submission of the plan to receipt of State aid); 2164(11) (mandating the annual report), 2168 (establishing a state-wide vaccination reporting system). In this way, the Legislature’s mandatory school vaccination program resembles the policy examined by this Court in Robin v. Inc. Village of Hempstead, 30 N.Y.2d 347 (1972). There, a village ordinance required all abortions to be performed in a hospital. Id. at 349. This Court ruled that the Legislature evidenced a policy to preempt the field because it “declared in the Public Health Law” that the Department of Health had the responsibility to create and administer the State’s policy regarding hospitals and related services. Id. The Legislature made the same policy choice here when it directed the State Health Commissioner to “develop and supervise” the State’s mandatory vaccination program, and required municipalities to have their mandatory school vaccination plans approved by the State Health Commissioner. See also Ardizzone v. Elliott, 75 N.Y.2d 150, 156 (1989) (holding that the Legislature intended to preempt local action regarding wetlands, even though it granted local officials some regulatory authority); Consol. Edison, 60 N.Y.2d at 103 (finding that the Legislature preempted the field of power generation, because it created a state-wide board with the authority to certify all electric generating facilities). 26 The Legislature further evidenced its plan to centralize control in this field by reserving certain power to itself. It explicitly provided that the authority it granted to the Commissioner, and municipalities, regarding vaccination did not include the power to “authorize mandatory immunization of adults or children, except as provided in” Sections 2164 and 2165. PHL § 613(1)(c). (See also R. 14.) The First Department asserted that this restriction only applies to the State Health Commissioner. (R. 509-10; App. Br. at 54.) Limiting the restriction to the State Health Commissioner, however, is at odds with the Legislature’s comprehensive and centralized scheme for the mandatory school vaccination program. Furthermore, such a limitation is contradicted by the language of the restriction, which states that “nothing in this subdivision” grants authority to mandate immunizations, and that subdivision includes the Legislature’s authorization for municipalities to establish local childhood vaccination programs. PHL § 613(1)(a), (1)(c). As such, by its terms the restriction applies to local vaccination programs. Even though this Court need not examine what motivated the Legislature to preempt the field of mandatory school vaccinations, doing so was a logical policy choice. By creating a single list of mandatory vaccinations, the Legislature gave parents and educators certainty as to what vaccinations are required for a child to attend school. Therefore, a child who moves school systems within the State is not 27 subject to differing vaccination requirements. Likewise, as the fraught history of amendments to Section 2164 shows, the topic of what vaccines children should be compelled to take is not without controversy. Supra § 2. As such, it is understandable that the Legislature would choose a single state-wide policy and restrict who can require new mandatory vaccinations. In sum, Sections 613, 2164 and 2165 establish the Legislature’s comprehensive and detailed scheme for regulating mandatory school vaccinations and its policy to preempt the field. They establish what vaccines are required to attend school, comprehensively regulate the administering and certification of those vaccines, establish standards and protocols for parents’ or students’ interaction with school and health officials, centralize oversight of vaccination programs, and place limits on the municipal and school programs for such vaccinations. iii. The First Department Failed to Find Field Preemption Because it Improperly Defined the Field too Broadly and Declared the PHL to be a Floor to be Regulated Above The First Department held that “[t]here is no field preemption here because the State has not assumed full regulatory responsibility over the entire field of disease control and vaccination.” (R. 506.) However, in reaching this decision, the First Department defined the field too broadly. In enacting and amending Sections 613, 2164 and 2165, the Legislature did not preempt all aspects of “disease control and vaccination.” The Legislature preempted a much narrower field: the field of 28 mandatory school vaccinations. See, e.g., Witty v. Delta Air Lines, Inc., 366 F.3d 380, 385 (5th Cir. 2004) (refusing to find all aspects of airline safety preempted, but holding that the FAA preempted the narrower field of airline safety warnings). By defining the field too broadly, the First Department improperly considered aspects of disease control that are irrelevant to the mandatory school vaccination program, such as the Municipal Home Rule Law’s grant of authority over the “health and well- being of” citizens, and local government’s general authority to create regulations “‘deem[ed] necessary and proper for the preservation of life and health.’” (R. 506- 07 (quoting PHL § 308(d)).) Adopting this broad view, both the First Department and Appellants here cited to PHL Sections 228(3) and 308(d) to argue that the vaccines required in Section 2164 represent a “floor for vaccination standards, leaving the Board free to fashion greater protections for the city.” (App. Br. at 4, 50; R. 507.) The First Department and Appellants misstate the law. Sections 228 and 308 only provide that the state “Sanitary Code” is a floor that local boards of health can regulate above. The Sanitary Code is the body of regulations created by the state Public Health and Health Planning Council, it is not synonymous with the PHL. See PHL § 225(4). In fact, nothing cited by Appellants or the First Department establishes that the PHL is merely a floor. Compare Bri-Mar Corp. v. Town of Knox, 74 N.Y.2d 826, 828 (1989) (cited by Appellants) (holding that local authorities could regulate above the 29 floor set by the state sanitary code) with New York Statewide Coal. of Hispanic Chambers of Commerce v. New York City Dep’t of Health & Mental Hygiene, 23 N.Y.3d 681, 694 (2014) (“Statewide Coalition”) (stating that the BOH can only create regulations that are subservient to State and local laws) and S. H. Kress & Co. v. Dep't of Health of City of New York, 283 N.Y. 55, 60 (1940) (holding that the PHL preempted a BOH regulation). To the contrary, here the Legislature explicitly stated that Section 2164 is not merely a floor, but rather a fixed list that local boards of health may not amend. PHL § 613(1)(c). The Legislature recognized that local health officials and schools play a role in the mandatory school vaccination program, as limited by State law and oversight. Supra § 1. However, contrary to the First Department and Appellants’ assertions, the fact that the Legislature acknowledged and limited these roles, serves as evidence for, not against, the Legislature’s intent to preempt the field of mandatory school vaccinations. See Cohen v. Bd. of Appeals of Vill. of Saddle Rock, 100 N.Y.2d 395, 401 (2003) (holding that the Legislature preempted the field of zoning variance review when it set the standard of review to be employed by local zoning boards); Albany Area Builders Ass’n, 74 N.Y.2d at 378 (finding field preemption of road maintenance funding because, while municipalities could expend funds, the Legislature regulated how they applied for and used the funds); De Jesus, 54 N.Y.2d 30 at 469 (noting that the State’s statutory structure, which imposed some “direct controls at the local level,” supported finding field preemption). B. The Flu Shot Rule Directly Conflicts with the Policy Established by the Legislature Even if the Court believes that the Legislature did not intend to preempt the field of mandatory school vaccination, the Flu Shot Rule should still be declared invalid because it conflicts with the Legislature’s policy regarding mandatory school vaccinations. “[A] local law is preempted … when a right or benefit is expressly given by State law which has then been curtailed or taken away by the local law.” Sunrise Check Cashing and Payroll Services, Inc. v. Town of Hempstead, 933 N.Y.S.2d 388, 395 (2d Dep’t 2011), aff’d sub nom. 20 N.Y.3d 481 (2013) (internal quotations omitted); see also Lansdown Entm’t Corp. v. N.Y. City Dep’t of Consumer Affairs, 74 N.Y.2d 761, 764 (1989) (“the direct consequences of a local ordinance should be examined to ensure that it does not render illegal what is specifically allowed by State law” (internal quotations omitted)). The Flu Shot Rule conflicts with State law in two ways. First, Section 2164 identifies the list of vaccinations a child must obtain to attend schools. Thus, the Legislature has determined that a child who has obtained those vaccinations can attend school. Section 2164’s list does not include the flu shot. PHL § 2164(2) . The Rule, however, authorizes preschools to deny entrance to children who do not receive an annual flu shot, and fines schools that accept children without that 31 vaccine. (R. 75-78 (at subdivision (a)(2)(C)).) Therefore, a child who has all the vaccinations required by Section 2164, but has not received the flu shot, would be denied admission. For those students, the Flu Shot Rule denies them the right to attend school granted by State law, and as such, this Rule directly conflicts with Section 2164. See Lansdown Entm’t Corp., 74 N.Y.2d at 764 (holding that a local ordinance requiring bars to close at 4:00 A.M. conflicted with State law permitting bar patrons to consume alcohol until 4:30 A.M.); Sunrise Check Cashing and Payroll Services, Inc., 933 N.Y.S.2d at 395 (finding that a local zoning ordinance limiting where check cashing businesses could open conflicted with a State law granting the State Superintendent of Banks authority to authorize check cashing locations because the effect of the ordnance was to render illegal what the State law permitted); see also Anonymous v. City of Rochester, 13 N.Y.3d 35, 52 (2009) (Graffeo, J., concurring) (where the Family Court Act established specific offences for which an officer could detain a child, a local ordinance allowing detention for an offense not on the Act’s list, conflicted with State law). The Rule’s conflict with State law is further evidenced by the legislative history of Sections 613 and 2164. After the CDC recommended the flu shot for preschoolers in 2007, the Legislature debated whether to mandate this vaccine. The Legislature specifically considered and rejected a bill to amend Section 2164 to add 32 the flu shot to the list of mandatory vaccinations. Bill No. A10942 at 1, 4 (2008).8 Ultimately, instead of mandating the vaccine, in 2010, the Legislature amended Section 613 to insert language directing the Commissioner to “administer a program of influenza education to the families of children ages six months to eighteen years of age who attend licensed and registered day care programs, nursery schools, pre- kindergarten … schools” PHL § 613(1)(b); L. 2010, ch. 36. This amendment mentioned Appellants by name, requiring the BOH to assist the State Health Commissioner in administering this program of influenza educational. Id. (See also R. 15.) By amending Section 613 to require flu shot education, but not amending Section 2164, the Legislature made the affirmative policy choice to encourage the flu shot, but not to mandate it for school admissions. By adopting the Flu Shot Rule, Appellants reversed this policy choice, and therefore, the Rule conflicts with Sections 613 and 2164.9 The Flu Shot Rule conflicts with State law in another way as well. Section 2164 designates the State Commissioner of Education as the person with authority 8 Original bill version available at http://public.leginfo.state.ny.us/navigate.cgi 9 Appellants argue that the Legislature’s decision to not amend Section 2164 to require the flu shot is a “dubious” basis to adduce legislative intent. (App. Br. at 33 n.20.) However, this argument ignores the actions that the Legislature affirmatively took with regard to Section 613. The choice made by the Legislature here is far more probative as to the Legislature’s intent than simple legislative inaction because here the Legislature affirmatively acted. Cf. NYC C.L.A.S.H., Inc. v. New York State Office of Parks, Recreation & Historic Pres., 27 N.Y.3d 174, 184 (2016) (cited by Appellants) (rejecting appellants attempt to ascribe motivation to the Legislature’s decision to not enact a particular bill because the court did not know why the Legislature chose not to act). 33 to hear any appeal of a school’s decision to deny a child admission due to a lack of required vaccinations. PHL § 2164(7)(b); N.Y. Educ. L. § 310(6-a). On the other hand, the Rule designates the City Health Commissioner as the person authorized to hear appeals of children denied admission due to a failure to obtain the influenza vaccination. (R. 75-78 (at subdivision (a)(2)(B)(ii)).) By designating a different appellate venue for the Flu Shot Rule, Appellants create another conflict between that Rule and State law. The Legislature designated the State Commissioner of Education as the venue for appeals of numerous decisions made by schools, not just vaccine related appeals. See N.Y. Educ. L. § 310(1)-(7). The purpose of centralizing all school related appeals is “to make all matters pertaining to the general school system of the state within the authority and control of the Department of Education and to remove the same so far as practicable from controversies in the courts.” 24A Carmody-Wait 2d § 145:687. Under the Flu Shot Rule, a parent who believes their child was wrongly denied admission due to a lack of several vaccinations could be required to appeal to both the State Commissioner of Education and the City Health Commissioner. This dual track appeal directly conflicts with the Legislatures’ desire to centralize all school appeals in the State Commissioner of Education. See Hwy. Superintendent Ass’n of Rockland, Inc. v. Town of Clarkstown, 54 N.Y.S.3d 60, 62 (2d Dep’t 2017) 34 (declaring a municipal law requiring State Highway Department mechanics be approved by the town was preempted by State law granting the power to hire mechanics to the State Highway Superintendent); Consol. Edison, 60 N.Y.2d at 108 (local law requiring town approval to perform a site study for a power plant conflicted with State law because it added an additional restriction to the permitting process). Moreover, dual track appeals could lead to conflicting results, a terrible situation for any litigant, let alone a parent trying to get their child into preschool. By conflicting with the Legislature’s stated policy to encourage but not mandate the flu shot, and by creating a separate appellate procedure, the Flu Shot Rule conflicts with State law. Therefore, the Rule should be declared invalid. C. Charter Section 558 and Admin. Code Section 17-109 do not Grant Appellants Authority to Require Mandatory School Vaccinations Appellants assert that NYC Charter Section 558 (“Charter Section 558”) and Admin. Code Section 17-109 represented “a highly specific delegation” to the BOH of the authority to require mandatory vaccinations for students entering school in NYC. However, those sections are merely broad grants of authority to Appellants that do not authorize them to require mandatory school vaccinations. Charter Section 558 provides that the BOH may add provisions to the city health code for “security of life and health in the city,” and Admin. Code Section 17-109 provides it may add necessary provisions to the city health code to “effectively prevent the spread of communicable disease.” Nevertheless, Section 35 558 and Admin. Code 17-109’s general grants of authority concerning “life and health” and preventing “the spread of communicable disease,” respectively, do not provide a basis to ignore State laws of general applicability regarding mandatory school vaccination. See S. H. Kress & Co., 283 N.Y. at 60. To the extent that Section 17-109 provides specific authority regarding vaccines, it is to “collect and preserve pure vaccine lymph or virus, produce diphtheria antitoxin and other vaccines and antitoxins” and “take measures, and supply agents and offer inducements and facilities for general and gratuitous vaccination, disinfection, and for the use of diphtheria antitoxin and other vaccines and antitoxins.” Admin. Code § 17-109. Conspicuously absent from the foregoing is permission to mandate vaccinations for adults or children. Id. The absence of this authority is no mere oversight. Admin. Code 17-109 once granted Appellants authority to “‘organize a corps of vaccinators’ for the ‘systemic vaccination of all unvaccinated persons’ residing in the City.” L. 1901, ch. 46. But, the Legislature long ago repealed that authority. Perhaps recognizing that they lack explicit authority, Appellants spend a great deal of time presenting what they claim is the history of the BOH’s role in vaccinations in NYC. (App. Br. at 4-12.) They argue that this Court should imply an exception for the BOH because, more than 40 years ago, when the Legislature 36 passed Section 2164, it knew that the BOH required additional mandatory school vaccines and did nothing to stop it. (App. Br. at 51.) However, “[t]he authority of a municipality to abrogate state law is never implied or inferred. It is only derived from express grant, never from a general grant of power. A state policy may not be ignored by a municipality unless it is specifically empowered so to do in terms clear and explicit.” S. H. Kress & Co., 283 N.Y. at 60 (rejecting the BOH’s claim that Charter Section 558 gave it the authority to ignore State law). Instead, as the Supreme Court found, “‘[t]he legislature is presumed to be aware of the law in existence at the time of an enactment, as well as of the effect and implications of its own enactments,’ and general statutes ‘must yield to later, more specific statutes.’” (R. 13 (quoting Wager v. Pelham Union Free Sch. Dist., 108 A.D.3d 849 (2d Dep’t 2013).) Even if at some point in the past the BOH did mandate some additional mandatory school vaccinations, it has long since lost that authority as the Legislature has enacted a much more detailed and specific state wide statutory scheme. See Dutchess County Dept. of Soc. Services v. Day, 96 N.Y.2d 149, 152-53 (2001) (“Another well-established rule of statutory construction provides that a prior general statute yields to a later specific or special statute” (internal quotations omitted)); S. H. Kress & Co., 283 N.Y. at 60 (“As all municipal authority comes from the Legislature, the provisions of municipal charters, however broad, are subject to such restrictions as may be imposed by general laws.”); 37 Dandomar Co., LLC v. Town of Pleasant Valley Town Bd., 924 N.Y.S.2d 499, 506 (2d Dep’t 2011) (finding that a statute that allowed tax enforcement officers to bring supplementary proceedings must yield to more specific statutes concerning foreclosure proceedings). Appellant’s argument for an implied exception is further undercut by the Legislature’s consistent practice of explicitly exempting NYC from other portions of the PHL. For example, the Legislature enacted laws regarding rabies, including providing for the vaccination of animals, in PHL Sections 2140 to 2145, but the Legislature provided in Section 2146 that these sections “shall not apply to the city of New York.” The Legislature has likewise explicitly excluded Appellants from numerous other sections of the PHL. See, e.g., PHL §§ 312, 545, 1106, 1309, 1503, 2110, 2125, 2153. No similar section exempts NYC from Sections 613, 2164 and 2165. Absent such an express exemption, this Court should not imply one. See Baldwin Union Free Sch. Dist. v. Cty. of Nassau, 22 N.Y.3d 606, 620 (2014) (citing S.H. Kress & Co.); Robin, 30 N.Y.2d at 350–51 (“Such State policy being expressed, a village or other municipality lacks authority to deal with the matter ‘unless it is specifically empowered so to do in terms clear and explicit.’” (quoting S.H. Kress & Co.)). In addition, even if the Court was inclined to grant an implied exemption, Appellants’ history presents no justification for it. In presenting their history, 38 Appellants do not once cite to anything in the record, instead they rely on a series of old state bills, woven together by counsel’s narrative description of the history of when certain vaccinations were required by the State and by Appellants. (App. Br. at 9-12.) Assuming the veracity of this history, it only discusses the BOH’s actions up to 1971.10 (App. Br. at 51 n.25.) As such, this history stops long before the Legislature added the relevant provisions in Section 613 centralizing authority over the vaccination program and restricting for itself the right to amend the list of mandatory vaccines. E.g., L. 2004 ch. 207 (adding the language restricting municipalities from requiring mandatory vaccinations); L. 2013, ch. 56, § 24 (Part E) (mandating that municipalities submit their immunization plans to the State Health Commissioner for approval). D. Appellants’ Arguments Regarding the BOH’s Authority are not Availing In their opening brief, Appellants attempt to avoid the preemptive effects of Sections 613, 2164, and 2165 by presenting several arguments to sidestep the concept of preemption. Nevertheless, none of these arguments are availing. 10 The only example from the last 40 years that Appellants provide where the BOH’s requirements for vaccinations differed from that of the State was where the BOH required an additional dose of diphtheria as compared to the state-wide requirement. (App. Br. at 11-12.) However, Appellants admit that at the time Section 2164 already require the diphtheria vaccine and this was just a difference of dosing, thus, it did not conflict with Section 613’s prohibition on requiring additional mandatory vaccinations. PHL § 613(1)(c). 39 Appellants initially assert that preemption is the wrong paradigm because the Flu Shot Rule, as embodied in the NYC Health Code, is of “equal dignity” with the PHL. (App. Br. at 42.) This blanket statement is incorrect. The NYC Health Code provisions are regulations put in place by the BOH, whereas the PHL is a State law of general applicability passed by the Legislature and signed by the Governor. Therefore, by definition, the Rule and the PHL are not of equal dignity. S. H. Kress & Co., 283 N.Y. at 60 (holding that a state law preempted a BOH regulation). This Court has already rejected the idea that the NYC Health Code is equivalent to a State law. As this court recently found, “the Charter contains no suggestion that the Board of Health has the authority to create laws … the Charter restricts the Board’s rulemaking to the publication of a health code, an entirely different endeavor.” Statewide Coalition, 23 N.Y.3d at 694. The BOH’s “authority, like that of any other administrative agency, is restricted to promulgating ‘rules necessary to carry out the powers and duties delegated to it by or pursuant to federal, state or local law.’” Id. (quoting NYC Charter § 1043(a)). “A rule has the force of law, but it is not a law; rather, it ‘implements or applies law or policy.’” Id. (quoting NYC Charter § 1041(5)(i)). As such, in the preemption analysis, the Flu Shot Rule is not the equivalent of State law, as Appellants suggest. To bolster their claim of equal dignity, Appellants assert that the BOH derived its authority to pass the Flu Shot Rule from Charter Section 558(b), Admin. Code 40 Section 17-109 and Soc. Serv. Law § 390(13), all of which Appellants claim “carry the force of State law.” (App. Br. at 42.) This argument, nevertheless, misses the fundamental reason why Respondents brought this action. Respondents are challenging the Rule as embodied in the NYC Health Code, asserting that the Rule itself is preempted by State law. Respondents are not arguing that the sections of State law Appellants claim gave them authority to adopt the Rule are preempted – though Appellants disagree that those sections provided the claimed authority. Appellants also argue that Respondents are claiming that the Legislature implicitly repealed its prior grant of authority to the BOH. (App. Br. at 43-47.) The Court, however, does not need to look to the question of repeal. “[A] statute is not deemed impliedly modified by a later enactment unless the two are in such conflict that both cannot be given effect[.]” Consol. Edison Co. of New York v. Dep’t of Envtl. Conservation, 71 N.Y.2d 186, 196 (1988) (cited by Appellants) (internal quotations omitted). The BOH continues to have the authority granted to it by the express terms of Charter Section 558(b) and Admin. Code Section 17-109. For example, the BOH can still “take measures, and supply agents and offer inducements and facilities for general and gratuitous vaccination, disinfection, and for the use of diphtheria antitoxin and other vaccines and antitoxins” as provided for in Section 17-109(b). But, neither section cited by Appellants grants the BOH the authority to require additional mandatory school vaccinations, and therefore, the Court does not 41 need to find express or implied repeal of either section to find the that the Legislature has chosen to preempt the field of mandatory school vaccinations. To the contrary, Section 17-109 works cooperatively with the State’s mandatory school vaccination program by granting the BOH the authority it needs to implement the requirements of Sections 613 and 2164 with regard to providing facilities and programs to vaccinate and educate children. See Consol. Edison Co. of New York, 71 N.Y.2d at 195 (“If by any fair construction, a reasonable field of operation can be found for [both] statutes, that construction should be adopted.” (internal quotations omitted)); Alweis v. Evans, 69 N.Y.2d 199, 205-06 (1987) (refusing to find implied repeal where “a reasonable field of operation [could] be found for each” statute such that they did not conflict). Appellants next claim that Soc. Serv. Law § 390(13) “exempts the City from State legislation” regarding day care programs, and as such, gave Appellants plenary authority to create regulations regarding such programs. (App. Br. p. 43.) This argument, however, vastly overstates the reach of Soc. Serv. Law § 390(13). By its terms, that paragraph only exempts NYC from the provisions of that one section; it makes no reference to any other sections of State law. On the other hand, Section 2164 applies, inter alia, to “any public, private or parochial child caring center, day nursery, day care agency, nursery school[,]” and makes no exception for those facilities in NYC. 42 II. THE FIRST DEPARTMENT CORRECTLY HELD THAT THE FLU SHOT RULE IS INVALID BECAUSE APPELLANTS EXCEEDED THE BOUNDS OF THEIR LEGISLATIVE AUTHORITY The Supreme Court held that the above preemption analysis establishes that the “Legislature retains the statutory authority to mandate vaccinations not already expressed within the” PHL, and as such this “is not a situation where it is difficult- to-demarcate the line between administrative rulemaking and legislative policymaking, thereby requiring a ‘Boreali’ analysis.” (R. 14 (internal quotations omitted).) Nevertheless, as the First Department found, an analysis of the framework expressed by this Court in Boreali establishes that Appellants engaged in making broad-based public policy decisions in violation of the role preserved for the Legislature in the State Constitution. The Boreali framework includes four coalescing factors that courts use to determine whether an agency, such as the BOH, crossed beyond its role of interstitial rulemaking and intruded upon the legislative arena. (R. 514-515.) In Statewide Coalition, another case against the BOH, this Court articulated the Boreali factors as follows: 1. “whether the agency engaged in the balancing of competing concerns of public health and economic cost, thus acting on its own idea of sound public policy” 43 2. “whether the agency created its own comprehensive set of rules without benefit of legislative guidance” 3. “whether the challenged rule governs an area in which the Legislature has repeatedly tried to reach agreement in the face of substantial public debate and vigorous lobbying by interested factions” 4. “whether the development of the rule required expertise in the field of health” 23 N.Y.3d at 692-93. In its decision in this action, the First Department correctly articulated the spirit and purpose of these coalescing factors: The four Boreali factors are not “discrete, necessary conditions that define improper policymaking by an agency” (…Statewide Coalition, 23 N.Y.3d at 696). Nor should they be “rigidly applied” whenever an agency is alleged to have engaged in improper lawmaking (id.). Instead, they are “overlapping, closely related factors that, taken together, support the conclusion that an agency has crossed” “the line into legislative territory” (id. at 696-697). The Boreali factors “are not mandatory, need not be weighed evenly, and are essentially guidelines for conducting an analysis of an agency’s exercise of power” (Greater N.Y. Taxi Assn. …, 25 N.Y.3d 600, 612 (2015)). Thus, an agency cannot turn back a challenge to a proposed regulation simply by showing that a Boreali factor is absent (…Statewide Coalition, 23 N.Y.3d at 697). (R. 511-512.) “[T]he touchstone under Boreali is whether the Legislature has ‘articulated a policy’ for an administrative agency to implement” and “[w]hen the legislature ‘has 44 spoken’ in favor of a policy, an agency” should not “usurp the legislative prerogative by … regulation.” (App. Br. at 24) (citations omitted.) Thus, for Appellants to engage in valid interstitial rulemaking, “the legislature must specifically delegate that power … and must provide adequate guidelines and standards for the implementation of that policy.” Subcontractors Trade Ass’n v. Koch, 62 N.Y.2d 422, 427-30 (1984) (emphasis in original); see also Broidrick v. Lindsay, 39 N.Y.2d 641, 645-46 (1976) (“executive action … may not go beyond stated legislative policy”); People ex rel. Spitzer v. Grasso, 42 A.D.3d 126, 141 (1st Dep’t 2007) aff’d 11 N.Y.3d 64 (2008) (same). Here, the Legislature “has spoken” and “articulated a policy” in Section 613 to promote rather than mandate the flu shot. The Legislature directed the State Health Commissioner to create a program to educate parents and students about the influenza virus and the flu shot, and explicitly instructed Appellants to assist with this program. PHL § 613(1)(b). But, the Legislature chose not to mandate the vaccine, as is clear from (a) its decision to not amend Section 2164; and (b) its placement of the education directive in the same subdivision as the provision where it precluded any “mandatory immunization of adults or children” other than as provided in Section 2164. PHL § 613(1)(c). Nevertheless, Appellants decided to ignore the Legislature’s chosen policy, and to instead mandate the flu shot. In creating this mandate, Appellants fashioned 45 their own unique regulatory regime for enforcing the new mandate. This included an unprecedented “opt-out provision and the uneven application to the various city child care providers.” (R. 517.) As the First Department determined, by ignoring the Legislature’s policy, and creating a new enforcement regime from whole cloth, Appellants trespassed beyond interstitial rulemaking. A. First Boreali Factor – The BOH Chose Between Policy Ends With regard to the first Boreali factor, it is the prerogative of legislative bodies, rather than administrative agencies, to address issues that “involve[] difficult social problems, which must be resolved by making choices among competing ends.” Statewide Coalition, 23 N.Y.3d at 692 (internal quotations omitted). As the public health administrative agency in NYC, the BOH is intended to take actions “solely with a view toward public health considerations[.]” New York Statewide Coal. of Hispanic Chambers of Commerce v. New York City Dep't of Health & Mental Hygiene, 110 A.D.3d 1, 10 (1st Dep’t 2013), aff'd, 23 N.Y.3d 681 (2014). The BOH intrudes on the legislative prerogative when it creates “a regulatory scheme on its own conclusions about the appropriate balance of trade-offs between health and cost to particular industries in the private sector” based “solely on [its] own ideas of sound public policy.” Boreali, 71 N.Y.2d at 12 (internal quotations omitted). Indeed, in Boreali this Court held that while the Department of Health was “generally acting to further the laudable goal of protecting nonsmokers from the 46 harmful effects of ‘passive smoking’ ... [s]triking the proper balance among health concerns, cost and privacy interests … is a uniquely legislative function.” Id. at 11- 12. The First Department found here that Appellants “improperly made value judgments by creating a regulatory scheme with exceptions not grounded in promoting public health.” (R. 512.) It stated two reasons for this conclusion. First, the BOH “made improper policy choices” because it applied the Flu Shot Rule to “less than 20% of child care facilities in the city” and none of the “more than 20,000 legally exempt child care providers.” (R. 513-514.) “The decision to place economic burdens on only a fraction of licensed child care facilities, albeit the larger ones, while not placing the same burdens on other facilities shows that the Board of Health was ‘making policy, and therefore was operating outside of its proper sphere of authority.’” (R. 514 (quoting Matter of Ahmed v City of New York, 129 A.D.3d 435, 440 (1st Dep’t 2015) (internal quotations omitted)).) The First Department rejected the BOH’s assertion that it only targeted these few child care providers “because it already possesses regulatory expertise with respect to those facilities[,]” concluding instead that Appellants’ “rationale is based on administrative convenience, not health-related concerns.” (R. 514.)11 11 For example, Creative Steps and Kaleidoscope Kids are two child care providers located next door to each other, yet only the former is subject to the Flu Shot Rule. (R. 86-88.) Hence, Creative 47 Second, the Flu Shot Rule did not prohibit unvaccinated children from attending pre-schools, it simply created a monetary fine for schools that admitted such children. (R. 513.) Contrary to Appellants’ assertion, the First Department was not “second-guessing” the BOH’s chosen enforcement mechanism. (App. Br. at 21.) Instead, the First Department focused on the fact that the Rule “provide[d] only that the facility ‘may’ refuse entry to the unvaccinated child … [which] stands in stark contrast to section 2164(7)(a) of the State’s Public Health Law, which, logically, forbids children from remaining in school without proof of the immunizations required under that statute.” (R. 513) (emphasis in original). As a result, the Flu Shot Rule “allow[s] a child care provider or school to make an economic choice to pay a fine rather than expel a student and lose a year’s worth of tuition.” (Id.) This economic rational: flies in the face of respondents’ claim that the challenged amendments are meant to promote the public health by reducing transmission of the flu virus. Not surprisingly, respondents are unable to point to any health-related reason supporting the opt-out provision. (Id.) See also Statewide Coalition, 23 N.Y.3d at 698-99 (stating that when the BOH chose to restrict, rather than prohibit sugary drinks, it made a public policy determination). Steps must decide whether to expel a child whose parent refuses the flu shot (and potentially lose that customer to Kaleidoscope Kids) or pay a fine. 48 Appellants counter the First Department’s holding by now claiming that the fine would be leveled daily for a school with an unvaccinated child, making the fine so crippling as to preclude any school from opting out of the Flu Shot Rule. (App. Br. pp. 16-17.) However, Appellants assert this argument for the first time before this Court. Respondents, asserted in their Verified Petition that “to lessen the economic burden on requiring expulsion, [Appellants] made the policy choice to permit centers to choose to instead pay a fine.” (R. 51.) As the First Department noted, Appellants never contested this point. (R. 516-17.) Indeed, if Appellants intended to impose such draconian fines that no school could accept an unvaccinated child, why did it draft the Rule to say that “a school may … refuse to allow any child to attend[,]” instead of a more affirmative statement, such as “shall refuse.” There are other examples of how Appellants improperly weighed public policy and non-health considerations, beyond the two noted by the First Department. Appellants attested below that in choosing to adopt the Rule, they sought to reduce the flu’s burden on the economy and increase worker productivity. (R. 141.) Appellants went so far as to quantify the lost wages for each parent as an express consideration for passing their Rule. (Id.) Furthermore, whenever a governmental body mandates that a person receive a vaccine, that body is intrinsically choosing between competing ends of health on the one hand and the civil and individual rights to bodily integrity, privacy, and 49 parental choice on the other hand. See Statewide Coalition, 23 N.Y.3d at 698 (determining that when the BOH made public policy determinations that took into consideration the “degree of autonomy a government permits its citizens to exercise and the ways in which it might seek to modify their behavior indirectly” it acted beyond its legislative bounds). This is precisely the type of policy weighing reserved for the Legislature, which the Legislature recognized when it prohibited the State Health Commissioner and local municipalities from requiring new mandatory immunizations. Id.; PHL § 613(1)(c).12 When viewed together, all of these competing considerations show that “the value judgments [made in adopting the Flu Shot Rule] entailed difficult and complex choices between broad policy goals[.]” Statewide Coalition, 23 N.Y.3d at 698. By making these value judgments without clear authorization from the Legislature, Appellants overstepped their authority. B. Second Boreali Factor – The BOH did not Merely Fill in Details The second Boreali factor asks whether the agency “merely fill[ed] in the details of broad legislation describing the over-all policies to be implemented” or did it write “on a clean slate” creating its own set of rules beyond what the Legislature dictated. Boreali, 71 N.Y.2d at 12. In Boreali the Legislature had 12 In passing the Rule, Appellants also made a policy choice to burden children with receiving the flu shot for the benefit of the elderly who are potentially vulnerable to the flu. (R. 50-51, 72, 81.) 50 enacted restrictions on smoking in certain designated areas (e.g., libraries and theaters). Id. at 7. This Court found that the state Public Health Counsel’s decision to add more public spaces, and to grant certain exceptions, went beyond filling in the details, but rather created a new set of rules “without benefit of legislative guidance.” Id. at 13. “Viewed in that light, the agency’s actions were a far cry from the ‘interstitial’ rule making that typifies administrative regulatory activity.” Id. Here, the First Department chose to analyze this factor by focusing exclusively on Admin. Code Section 17-109, which Appellants now claim provided “specific statutory authority” to pass the Rule. (App. Br. at 31.) Using this narrow focus, the First Department found that the second Boreali factor favored Appellants. (R. 514-515.) In reaching this conclusion, the First Department incorrectly found that the language in Admin. Code Section 17-109 gave Appellants authority to adopt any regulations it saw necessary regarding “vaccination of city residents.” (Id.) However, Section 17-109 makes no mention of schools or the authority to mandate vaccinations for school admission. Likewise, that section did not provide Appellants with specific authority to allow schools to choose to admit an unvaccinated child and pay a fine, or to limit the rule to just larger daycare centers while excluding smaller ones, or to make decisions to benefit the economy or increase worker productivity, or to create its own separate appellate procedures. As in Boreali, in making each of 51 these choices Appellants “wrote on a clean slate, creating [their] own comprehensive set of rules without benefit of legislative guidance.” 71 N.Y.2d at 13. Moreover, in Boreali and Statewide Commission, the agencies acted in areas where the Legislature had provided no specific instructions for those agencies to act. Statewide Coalition, 23 N.Y.3d at 699-700; Boreali, 71 N.Y.2d at 12. In contrast, here, the Legislature created a detailed statutory structure in Sections 613, 2164 and 2165. To the extent that Admin Code Section 17-109 provides some authority concerning vaccines, it “must yield to th[ose] more recent and more specific statutes.” (R. 13.) In fact, in those statutes the Legislature clearly set forth what role it envisioned for the BOH when it instructed the BOH to assist the State Health Commissioner in his program to educate children and parents regarding the flu shot. PHL § 613(1)(b). Thus, despite Section 17-109’s references to vaccination, it does not expressly include authority to create the Rule or to make any of the policy decisions made by Appellants. By making those decisions, Appellants “did not merely fill in the details” of existing legislation, but rather acted on their own sense of public policy needs.13 Boreali, 71 N.Y.2d at 13. When viewed in light of the Legislature’s comprehensive statutory structure, it is clear these actions were outside their 13 The Rule’s unprecedented nature is reflected in Appellants’ published FAQs for the Rule, including this frequently asked question: “Does the New York City Department of Health have the authority to require this immunization?” (R. 80-82.) 52 administrative scope. See Ahmed v. City of New York, 129 A.D.3d 435, 440 (1st Dep’t 2015) (holding that even though the TLC had certain delineate powers to ensure that drivers are capable of driving safely, that did not authorize it to establish insurance services for drivers). C. Third Boreali Factor – The BOH Acted in an Area in Which the Legislature Not Only Tried to Reach Agreement, It Reached Agreement The third Boreali factor is whether the executive acted in an area in which the Legislature has tried, but failed, to reach agreement. In reviewing whether an agency overstepped its administrative bounds, courts “consider the significance of legislative inaction as evidence that the Legislature has so far been unable to reach agreement on the goals and methods that should govern in resolving a society-wide health problem.” Boreali, 71 N.Y.2d at 13. This inaction is important because when the Legislature fails to act, that does “not automatically entitle an administrative agency to take it upon itself to fill the vacuum and impose a solution of its own.” Id. In 2008, the Legislature took up debate on a bill “at [the] request of the Department of Health” to amend Section 2164 to make all pediatric vaccines recommended by the CDC, which includes the flu shot, mandatory for all children attending school in the State. Bill No. A10942 at 1, 4 (2008).14 The bill was referred to the Assembly’s Health committee, which swiftly amended it to delete the 14 Original bill version available at http://public.leginfo.state.ny.us/navigate.cgi 53 Department of Health’s request that all vaccines recommended by the CDC be made mandatory. Bill No. A10942-A (2008). In contrast, the two states that Appellants note require the flu shot, Connecticut and New Jersey, have legislation that expressly authorizes their health agencies to mandate that children receive all vaccines recommended by the CDC. Conn. Gen. Stat. §§ 19a-79, 19a-7f (“to attend any child day care center … each child shall be … immuniz[ed] against diphtheria, pertussis … and any other vaccine required by the …. Commissioner of Public Health …. based on recommended schedules for active immunization … published by the [CDC],” which includes the flu shot); N.J.A.C. 26:2-137.1b. (“The Department of Health shall specify by regulation … [t]he childhood immunizations recommended by the [CDC].”); (App. Br. at 13.) This is the concept the Legislature rejected in 2008. Bill No. A10942 (2008). The First Department found that the Department of Health’s proposed 2008 “legislation is insufficient to show ‘repeated failures by the Legislature to [reach] an agreement’” in the area where the BOH acted, and as a result, the third Boreali factor did not favor either side. (R. 515-516 (quoting Boreali, 71 N.Y.2d at 13).) However, the view taken by the First Department was too narrow. The 2008 bill that the Legislature rejected was not the only time that it considered what policy it should adopt regarding the flu shot. To the contrary, since the CDC recommended the flu 54 shot in 2007, the Legislature has repeatedly considered how to best deal with the flu shot question. In each of those instances, it chose not to mandate the flu shot, but rather to promote the flu shot and leave the ultimate decision whether to receive the shot up to individual citizens. In 2007 the Legislature first took up a bill to amend Section 613 regarding flu shot immunization. (Supra § 3.) After being extensively debated, amended, conferenced, voted-upon, and reintroduced for years, the Legislature finally passed this bill in 2010. (Id.) The resulting legislature, entitled “Influenza Disease and Influenza Immunizations,” required the State Health Commissioner to “administer a program of influenza education to the families of children … who attend licensed and registered day care programs,” including regarding “the benefits of influenza immunizations.” L. 2010, ch. 36. However, it did not amend Section 2164 to mandate the flu shot. Id. This was not the only time the Legislature specifically considered a policy regarding whether to mandate or promote the flu shot. In fact, in 2009 the Legislature, again after years of legislative process, chose to promote but not mandate the flu shot for individuals entering neo-natal units. L. 2009, ch. 282; A05475 (2007); S04601 (2007); A05475A (2008); S04601A (2008); S00876 (2009); A03911 (2009); S00876A (2009); A03911A (2009). Likewise, in 2006, the Legislature chose to promote but not mandate the flu shot for individuals over 65 55 years old admitted to a hospital. L. 2006, ch. 266. The Legislature even chose to twice reject bills authorizing the health department to merely study the feasibility of a school-based flu shot pilot program. Bill Nos. A11526 (2008), A03706 (2010). Thus, the Legislature consistently chose to encourage everyone to receive the flu shot, but not to mandate the shot. Based on this history, it is clear that the Legislature has repeatedly examined the question of how to deal with the flu shot, and has repeatedly come to the same conclusion – to promote the flu shot rather than require it. Thus, Appellants here did not merely act in an area in which the Legislature has tried, but failed, to reach agreement. Worse. Appellants acted in an area where the Legislature has reached agreement but the Appellants have chosen to take the opposite approach. D. Fourth Boreali Factor - No Technical Competence Required for the Flu Shot Rule The First Department stated: “[t]he fourth Boreali factor – whether the agency used special expertise in its field – weighs in favor of [Respondents].” (R. 516.) In Boreali this Court acknowledged that “indoor smoking is unquestionably a health issue[,]” but it focused on the method of implementation when it examined the fourth factor, holding that the Public Health Counsel acted outside its area of competence when it chose “the locales in which smoking would be prohibited and provid[ed] exemptions for various special interest groups.” 71 N.Y.2d at 13-14. Similarly, here, the First Department correctly held: 56 The notice of adoption of the challenged amendments … [inter alia] points out that … the CDC … recommends that everyone … receive an annual flu vaccination. Nevertheless, this Boreali factor supports [Respondents], because no special expertise was relied upon to develop the unique scheme that was adopted here. The notice of adoption does not contain any health-related basis supporting either the opt-out provision or the decision to apply the vaccination requirement to only a fraction of the city’s child care facilities. Likewise, the affidavit of the First Deputy Commissioner of the Department of Health, submitted before the motion court, is silent on these issues. (R. 516.) E. Appellants’ Arguments that the Boreali Framework Should Not Apply, or that the First Department Applied it too Rigidly are Unavailing Appellants argue that the First Department viewed the Boreali factors as a rigid checklist whereby a plaintiff can overturn an agency decision by edging “the agency out—two to one, with one push[.]” (App. Br. at 33.) However, this description distorts the First Department’s analysis, which was clear that “the factors are not necessary conditions, should not be rigidly applied … and need not be weighed evenly.” (R. 511-12 (internal quotations omitted).) In reality, Appellants disagree with how the First Department weighed the factors. The First Department looked at each Boreali factor in turn, and noted that in its estimation “two of the Boreali factors weigh in favor of petitioners, one leans in favor of respondents, and one does not support either party[,]” but it did not base its decision on this two to one score as Appellants suggest. (R. 517.) Instead, the First 57 Department concluded that the “Boreali factors, when viewed together” show that the Rule “was not primarily grounded in science or health, but involved improper policy decisions, and thus did not constitute appropriate rulemaking.” (R. 518.) This is precisely the type of conclusion this Court reached in Boreali and Statewide Coalition where it examined each factor in turn, but ultimately viewed all the factors together when making its rulings. Instead, it is Appellants who are attempting to turn the factors into a rigid test. Appellants assert, without support, that the second Boreali factor is “the most pivotal of Boreali’s coalescing circumstances.” (App. Br. at 33.) Appellants use this dubious assertion to claim that because Admin. Code Section 17-109 references vaccines as part of the BOH’s grant of authority, that fact alone is sufficient to end the entire Boreali analysis. (Id.) But that is not the law. “Boreali’s central theme [is] that an administrative agency exceeds its authority when it makes difficult choices between public policy ends, rather than finds means to an end chosen by the Legislature.” Statewide Coalition, 23 N.Y.3d at 700. Here by adopting the Rule, in contradiction to established legislative policy, and by creating a new regulatory scheme to enforce that Rule, Appellants made the difficult policy choice on its own, and in doing so acted outside their administrative fiat. Cf. Statewide Coalition, 110 A.D.3d at 9 (an agency acts within its authority when it enacts regulations “consistent with the policies contemplated by the legislature”) 58 Appellants additionally argue that “the Legislature has declared ‘its policy in general terms,’” and they were merely filling in the details. (App. Br. at 24 (quoting Matter of Citizens for Orderly Energy Policy, Inc. v. Cuomo, 78 N.Y.2d 398, 410 (1991).) Appellants rely on N.Y.S. Health Facilities Association, Inc. v. Axelrod, and Citizens for an Orderly Energy Policy, to support this conclusion. Nevertheless, the statutes in those cases were far more specific in granting the agencies the authority they sought to use than Section 17-109 is here. In N.Y.S. Health Facilities Association, the challenged regulations sought to eliminate discrimination against Medicaid patients accessing nursing homes, based on a law that required for profit health care providers to not discriminate against Medicaid patients. 77 N.Y.2d 340, 347-48 (1991). In Citizens for an Orderly Energy Policy, a public authority closed a nuclear power plant pursuant to an enacting law that “expressly declared its legislative policy” to do exactly that. 78 N.Y.2d at 411. In contrast, here, Admin. Code Section 17-109 provides no specific authority regarding the flu shot or mandatory school vaccinations, while PHL Section 613 expressly declares the legislative policy to encourage, but not mandate, the flu shot. Thus, Appellants were not filling in the details of the Legislature’s generally declared policy, but rather acting in contradiction thereof. CONCLUSION Respondents respectfully request that the Court deny Appellants’ appeal and affirm the determination of the Supreme Court and the First Department that the Rule is invalid. Dated: September 8, 2017 S1RI & GLIMSTAD LLP Aaron Siri Mason Barney 200 Park Avenue, 17th Floor New York, New York 10166 Tel: (212) 532-1091 Pro Bono Counsel for Plaintiffs-Petitioners/Respondents 59 NEW YORK STATE COURT OF APPEALS CERTIFICATE OF COMPLIANCE I hereby certify pursuant to 22 NYCRR PART 500.l(j) that the foregoing brief was prepared on a computer using Microsoft Word 2010. Type. A proportionally spaced typeface was used, as follows: Name of typeface: Times New Roman Point size: 14 Line spacing: Double Word Count. The total number of words in this brief, inclusive of point headings and footnotes and exclusive of pages containing the table of contents, table of citations, proof of service, certificate of compliance, corporate disclosure statement, questions presented, statement of related cases, or any authorized addendum containing statutes, rules, regulations, etc., is 13,994 words. Dated: September 8, 2017 By: Aaron Siri, Esq. SIRI & GLIMSTAD LLP Pro Bono Attorneys for Respondents 200 Park Avenue, 17th Floor New York, New York 10166 Tel.:(212) 532-1091 Fax: (646)417-5967