Furilazole; Inert Ingredient Tolerances

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule.

SUMMARY:

This regulation establishes tolerances for residues of furilazole (3-dichloroacetyl-5-(2-furanyl)-2, 2-dimethyloxazolidine; (CAS Reg. No. 121776-33-8) under 40 CFR 180.471 when used as a pesticide inert ingredient safener on the sorghum commodities forage, grain, and stover at 0.01 parts per million (ppm). The Monsanto Company submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA), requesting an exemption from the requirement of a tolerance.

DATES:

This regulation is effective October 10, 2007. Objections and requests for hearings must be received on or before December 10, 2007, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES:

EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2007-0557. To access the electronic docket, go to http://www.regulations.gov , select “Advanced Search,” then “Docket Search.” Insert the docket ID number where indicated and select the “Submit” button. Follow the instructions on the regulations.gov web site to view the docket index or access available documents. All documents in the docket are listed in the docket index available in regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either in the electronic docket at http://www.regulations.gov , or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT:

Karen Angulo, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 306-0404; e-mail address: angulo.karen@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:

• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document?

In addition to accessing an electronic copy of this Federal Register document through the electronic docket at http://www.regulations.gov , you may access this Federal Register document electronically through the EPA Internet under the “Federal Register” listings at http://www.epa.gov/fedrgstr . You may also access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr .

C. Can I File an Objection or Hearing Request?

Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2007-0557 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before December 10, 2007.

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2007-0557, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov . Follow the on-line instructions for submitting comments.
• Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
• Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305-5805.

II. Background and Statutory Findings

In the Federal Register of June 1, 2005 (70 FR 31459) (FRL-7715-7), EPA issued a notice pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the Food Quality Protection Act (FQPA), announcing the filing of a pesticide petition (PP 5E6919) by the Monsanto Company. The petition requested that 40 CFR 180.471 be amended by the addition of tolerances for residues of furilazole (3-dichloroacetyl-5-(2-furanyl)-2, 2-dimethyloxazolidine; (CAS Reg. No. 121776-33-8) on the sorghum commodities bran, flour, forage, grain, and stover at 0.01 parts per million (ppm). That notice included a summary of the petition prepared by the petitioner. No comments were received in response to the notice of filing.

Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(c)(2)(A)(ii) of the FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of the FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .” These provisions were added to the FFDCA by the Food Quality Protection Act (FQPA) of 1996.

III. Risk Characterization and Conclusions

Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxic effects caused by furilazole is discussed in this unit. EPA has sufficient data to assess the hazards of and make a determination on aggregate exposure for the chemical. The following provides a brief summary of the risk assessment and conclusions for the Agency's review of furilazole. The full decision document for this action is available on EPA's Electronic Docket at http://www.regulations.gov/ under docket number EPA-HQ-OPP-2007-0557.

A. Human Health

The Agency reviewed the available information on furilazole submitted by the petitioner and determined that the toxicity database is sufficient. The toxicity studies used here were submitted for the establishment of tolerances of furilazole on corn commodities (Federal Register of April 3, 2002 (67 FR 15727) (FRL-6828-4). Laboratory studies in rodents show that exposure to furilazole may cause effects to the liver. In a 90-day oral toxicity study on rodents, the no observed effects level (NOAEL) was 7 milligrams/kilograms/day (mg/kg/day) and the lowest observed effects level (LOAEL) was 34/38 mg/kg/day (male/female), and in a chronic toxicity study on the rat the NOAEL was 0.26 mg/kg/day and the LOAEL was 5.05 mg/kg/day. Evidence of carcinogenicity was observed in rodents. For developmental toxicity, effects (increased number of re-sorptions; NOAEL was 10 mg/kg/day and the LOAEL was 75 mg/kg/day) were observed at maternally toxic doses. In the final rule, the Agency concluded “no qualitative or quantitative evidence of increased susceptibility in the rat or rabbit fetuses following in-utero exposure in the developmental toxicity studies nor to the offspring following prenatal/postnatal exposure in the 2-generation reproduction study.” The Agency further concluded “taking into account the lack of increased susceptibility and the completeness of the data on toxicity and exposure, EPA determined that the 10X safety factor to protect infants and children should be removed.” There are no residual uncertainties regarding prenatal and/or postnatal toxicity.

B. Exposure Assessment

The potential for exposure to residues of furilazole is adequately characterized based on the results of modeling and the crop residue studies. The results of the Dietary Exposure Evaluation Model (DEEM) model developed when tolerances for furilazole were first established on corn estimated that the amount of the dietary chronic population adjusted dose (cPAD) for the U.S. population was 1.4%, and the highest amount of the cPAD was 3.4% for all infants less than 1 year old. Estimates for potential cancer risks were also very low.

Residue studies (crop field trials and processed) show that residues of furilazole on sorghum commodities were non-quantifiable (less than the Limit of Quantitation (LOQ) of 0.010 ppm) in all samples of sorghum forage, grain, and stover.

Considering the results of the residue studies for furilazole on sorghum commodities and exposure modeling, the Agency concludes that dietary (food and drinking water) exposures of concern are not anticipated from the inert ingredient use of furilazole on the sorghum commodities forage, grain, and stover. Residential exposure is not expected because applications are limited to the agricultural crop sorghum. EPA is not aware of non-pesticide uses of furilazole, therefore, no further aggregate assessment is necessary.

C. Safety Factor for Infants and Children

Section 408 of the FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a margin of exposure analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans. The toxicity database is sufficient for furilazole and potential exposure is adequately characterized based on results of the residue studies for furilazole on sorghum commodities and exposure modeling. In terms of hazard, there are low concerns and no residual uncertainties regarding prenatal and/or postnatal toxicity. Taking into account the lack of increased susceptibility and the completeness of the data on toxicity and exposure, EPA determined that the 10X safety factor to protect infants and children should be removed.

D. Cumulative Exposure

Section 408(b)(2)(D)(v) of the FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to furilazole and any other substances, and the chemical does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that furilazole has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative .

E. Other Considerations

1. Analytical methods. Adequate enforcement methodology (capillary gas chromotography using electron capture detection) is available to enforce the tolerance exemption expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address: residuemethods@epa.gov.

2. International tolerances. The Agency is not aware of any country requiring a tolerance for furilazole nor have any CODEX Maximum Residue Levels (MRLs) been established for any food crops at this time.

F. Determination of Safety and Conclusions

The petitioner requested tolerances for sorghum flour and bran, nevertheless, these tolerances are not being established. The Agency has determined that tolerances for these processed commodities are not necessary because the residue data showed that residues of furilazole were non-quantifiable (less than 0.010 ppm) in all samples of grain (RAC) and processed fractions.

Laboratory studies in show that exposure to furilazole may cause effects to the liver and evidence of carcinogenicity was observed. Developmental effects were observed at maternally toxic doses and there was no qualitative or quantitative evidence of increased susceptibility in the rat or rabbit fetuses. Therefore, the 10X safety factor to protect infants and children is removed.

The results of the DEEM model that was developed when tolerances for furilazole were first established estimated the amount of the dietary cPAD for the U.S. population was 1.4%, and the highest amount of the cPAD was 3.4% for all infants less than 1 year old. Estimates for potential cancer risks were also very low. Residue studies (crop field trials and processed) on sorghum commodities show that residues of furilazole were non-quantifiable (less than the LOQ of 0.010 ppm). Considering the results of the residue studies and the conservative exposure modeling, the Agency concludes that dietary (food and drinking water) exposures of concern are not anticipated from the inert ingredient use of furilazole on sorghum commodities. Residential exposure is not expected because applications are limited to the agricultural crop sorghum. The Agency is not aware of any non-pesticide uses of furilazole, therefore, no further exposure assessment is necessary.

Based on the information in this preamble, EPA concludes that there is a reasonable certainty of no harm to the general population, including infants and children, from aggregate exposure to residues of furilazole. Accordingly, EPA finds that establishing tolerances for furilazole will be safe. EPA is establishing tolerances under 40 CFR 180.471 for residues of furilazole in or on the sorghum commodities forage, grain, and stover at 0.01 ppm when it is used as an inert ingredient safener.

In addition, the annual application rate limitation found in 40 CFR 180.471 is being removed because it is unnecessary. The establishment of tolerance levels provides adequate regulation under FFDCA.

IV. Statutory and Executive Order Reviews

This final rule establishes tolerances under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply.

This final rule directly regulates growers, food processors, food handlers and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000) do not apply to this rule. In addition, This rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).

V. Congressional Review Act

The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

• Environmental protection
• Administrative practice and procedure
• Agricultural commodities
• Pesticides and pests
• Reporting and recordkeeping requirements

Therefore, 40 CFR chapter I is amended as follows:

PART 180—AMENDED

1. The authority citation for part 180 continues to read as follows:

Authority: 21 U.S.C. 321(q), 346a and 371.

2. In §180.471, paragraph (a) is amended by revising the introductory text and by alphabetically adding commodities to the table to read as follows:

(a) General. Tolerances are established for residues of furilazole; 3-dichloroacetyl-5-(2-furanyl)-2, 2-dimethyloxazolidine (CAS Reg. No. 121776-33-8) when used as an inert ingredient (safener) in pesticide formulations in or on the following raw agricultural commodities: