E6-13659. Triflumizole; Pesticide Tolerances for Emergency Exemptions

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule.

SUMMARY:

This regulation establishes time-limited tolerances for combined residues of triflumizole in or on turnip, greens. Additionally, this regulation increases the tolerance levels and extends time-limited tolerances for Chinese Napa cabbage, collards, coriander leaves (cilantro), kale, kohlrabi, mustard greens and parsley. Further, this regulation extends time-limited tolerances for broccoli, dandelion and Swiss chard. This action is in response to EPA's granting of emergency exemptions under section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide on parsley, dandelion, Swiss chard, collards, kale, kohlrabi, mustard greens, Chinese Napa cabbage, broccoli, coriander leaves (cilantro), and turnip greens. This regulation establishes, revises, and/or extends a maximum permissible level for residues of triflumizole in these food commodities. These tolerances expire and are revoked on December 31, 2009.

DATES:

This regulation is effective August 23, 2006. Objections and requests for hearings must be received on or before October 23, 2006, 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-2006-0461. All documents in the docket are listed on the regulations.gov website. 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 Office of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket telephone number is [phone].

FOR FURTHER INFORMATION CONTACT:

Libby Pemberton, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: [phone]; e-mail address: [e-mail].

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-2006-0461 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 October 23, 2006.

-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-2006-0461, 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 Building), 2777 S. Crystal Drive, 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 telephone number is [phone].

II. Background and Statutory Findings

-EPA, on its own initiative, in accordance with sections 408(e) and 408 (l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, is establishing tolerances for combined residues of the fungicide triflumizole,1-(1-((4-chloro-2-trifluoromethyl)phenyl)imino)-2-propoxyethyl)-1H-imidazole, and its metabolites containing the 4-chloro-2-trifluoromethylaniline moiety, calculated as the parent compound, in or on turnip, greens at 20 parts per million (ppm) and increasing the tolerance levels in or on cabbage, Chinese, Napa at 20 ppm; collards at 20 ppm; coriander, leaves at 20 ppm; kale at 20 ppm; kohlrabi at 20 ppm; mustard, greens at 20 ppm; and parsley, leaves at 20 ppm. Further, this regulation extends time-limited tolerances for broccoli at 1.0 ppm; dandelion, leaves at 7.0 ppm and Swiss chard at 7.0 ppm. These tolerances expire and are revoked on December 31, 2009. EPA will publish a document in the Federal Register to remove the revoked tolerances from the Code of Federal Regulations (CFR).

-Section 408(l)(6) of the FFDCA requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under section 18 of FIFRA. Such tolerances can be established without providing notice or period for public comment. EPA does not intend for its actions on section 18 related tolerances to set binding precedents for the application of section 408 of the FFDCA and the new safety standard to other tolerances and exemptions. Section 408(e) of the FFDCA allows EPA to establish a tolerance or an exemption from the requirement of a tolerance on its own initiative, i.e., without having received any petition from an outside party.

-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(b)(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. . . .”

-Section 18 of the FIFRA authorizes EPA to exempt any Federal or State agency from any provision of FIFRA, if EPA determines that “emergency conditions exist which require such exemption.” This provision was not amended by the Food Quality Protection Act of 1996 (FQPA). EPA has established regulations governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Triflumizole on Parsley, Dandelion, Swiss Chard, Collards, Kale, Kohlrabi, Mustard Greens, Chinese Napa Cabbage, Broccoli, Coriander Leaves (Cilantro), and Turnip Greens and FFDCA Tolerances

Texas has declared a crisis exemption under FIFRA section 18 for the use of triflumizole on parsley, dandelion, Swiss chard, collards, kale, kohlrabi, mustard greens, Chinese Napa cabbage, broccoli, coriander leaves (cilantro), and turnip greens for control of powdery mildew. Texas states that the effective control of powdery mildew over the 70-90 day growing season requires two additional applications of a systemic pesticide beyond those permitted on the currently registered alternative labels. After having reviewed the submission, EPA concurs that emergency conditions exist for this State.-

-As part of its assessment of this emergency exemption, EPA assessed the potential risks presented by residues of triflumizole in or on parsley, dandelion, Swiss chard, collards, kale, kohlrabi, mustard greens, Chinese Napa cabbage, broccoli, coriander leaves (cilantro), and turnip greens. In doing so, EPA considered the safety standard in section 408(b)(2) of the FFDCA, and EPA decided that the necessary tolerances under section 408(l)(6) of the FFDCA would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemptions in order to address urgent non-routine situations and to ensure that the resulting foods are safe and lawful, EPA is issuing these tolerances without notice and opportunity for public comment as provided in section 408(l)(6) of the FFDCA. Although these tolerances expire and are revoked on June 30, 2009, under section 408(l)(5) of the FFDCA, residues of the pesticide not in excess of the amounts specified in the tolerances remaining in or on parsley, dandelion, Swiss chard, collards, kale, kohlrabi, mustard greens, Chinese Napa cabbage, broccoli, coriander leaves (cilantro), and turnip greens after that date will not be unlawful, provided the pesticide is applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by these tolerances at the time of that application. EPA will take action to revoke these tolerances earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe.

-Because these tolerances are being approved under emergency conditions, EPA has not made any decisions about whether triflumizole meets EPA's registration requirements for use on parsley, dandelion, Swiss chard, collards, kale, kohlrabi, mustard greens, Chinese Napa cabbage, broccoli, coriander leaves (cilantro), and turnip greens or whether permanent tolerances for these uses would be appropriate. Under these circumstances, EPA does not believe that these tolerances serve as a basis for registration of triflumizole by a State for special local needs under FIFRA section 24(c). Nor do these tolerances serve as the basis for any State other than Texas to use this pesticide on these crops under section 18 of FIFRA without following all provisions of EPA's regulations implementing FIFRA section 18 as identified in 40 CFR part 166. For additional information regarding the emergency exemptions for triflumizole, contact the Agency's Registration Division at the address provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

-EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of the FFDCA and a complete description of the risk assessment process, see http://www.epa.gov/​fedrgstr/​EPA-PEST/​1997/​November/​Day-26/​p30948.htm.

-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. EPA has sufficient data to assess the hazards of triflumizole and to make a determination on aggregate exposure, consistent with section 408(b)(2) of the FFDCA, for time-limited tolerances for combined residues of triflumizole in or on parsley, leaves at 20 ppm; dandelion, leaves at 7.0 ppm; Swiss chard at 7.0 ppm; collards at 20 ppm; kale at 20 ppm; kohlrabi at 20 ppm; mustard, greens at 20 ppm; Cabbage, Chinese, Napa at 20 ppm; broccoli at 1.0 ppm; coriander, leaves at 20 ppm; and turnip, greens at 20 ppm. The most recent estimated aggregate risks resulting from the use of triflumizole are discussed in the Federal Register for April 8, 2005 (70 FR 17908) (FRL-7701-6). This final rule established time-limited tolerances for residues of triflumizole in or on parsley, leaves; dandelion, leaves; Swiss chard; collards; kale; kohlrabi; mustard greens; cabbage, Chinese, Napa; broccoli; and coriander, leaves (cilantro) in connection with a crisis exemption declared by the state of Texas, December 21, 2004.

A new risk assessment was conducted for the current action to include the proposed use on turnip greens and due to the submission of new residue chemistry data and subsequent necessary revision to the time-limited tolerances on the aforementioned crops. Refer to the April 8, 2005 Federal Register document for a detailed discussion of the aggregate risk assessments and determination of safety. Below is a brief summary of the aspects of the risk assessment which are affected by the change of tolerances.

-EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies 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. A summary of the toxicological dose and endpoints for triflumizole for use in human risk assessment is discussed in Unit IV.A. of the Federal Register of April 8, 2005 (70 FR 17908).

EPA assessed risk scenarios for triflumizole under acute and chronic aggregate exposure (food + drinking water). Short-, intermediate-, and long-term aggregate risk assessments were not performed because there are no registered or proposed residential uses for triflumizole. A cancer aggregate risk assessment was not performed because triflumizole is not carcinogenic.

-The Dietary Exposure Evaluation Model - Food Commodity Intake Database (DEEM- FCID^TM) analysis evaluated the individual food consumption as reported by respondents in the USDA 1994-1996, 1998 nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity.

-Acute dietary exposure assessments were conducted for the general U.S. population (including infants and children) and females 13-49 years old using tolerance level residues and 100% crop treated (CT) information for all registered and proposed uses). Drinking water was incorporated directly in the dietary assessment using the acute (peak) concentration for surface water generated by the FIRST model.

Using these exposure assessments, the EPA concluded that triflumizole exposure from food and water consumption will utilize 9.3 % of the aPAD for U.S. Population, 21% of the a PAD for all infants less than 1 year old, 25% of the aPAD for children 1-2 years old, the subpopulation at greatest exposure and 17% of the aPAD for females 13-49 years old. Therefore, EPA does not expect the aggregate exposure to exceed 100% of the aPAD.

-A refined, chronic dietary exposure assessment was performed for the general U.S. population and various population subgroups using anticipated residues (ARs) from average field trial residues for apple, grape, pear, cherry, cucurbit, strawberry, and milk commodities; registered and proposed tolerance for all other commodities; % CT information for apples, grapes and pear commodities; and 100% CT information for all other uses. Drinking water was incorporated directly into the dietary assessment using the chronic (annual average) concentration for surface water generated by the FIRST model.

-Using these exposure assumptions, the EPA concluded that exposure to triflumizole from food and water will utilize 17% of the cPAD for the general U.S. population, 24% of the cPAD for all infants less that 1 year old and 31% of the cPAD for children 1-2 years old, the subpopulation at greatest exposure. Therefore, EPA does not expect the aggregate exposure to exceed 100% of the cPAD.

V. Other Considerations

A. Analytical Enforcement Methodology

-Adequate enforcement methodology (gas chromatography(GC)/nitrogen-phosphorus detector (NPD) method) has been deemed acceptable as a tolerance enforcement method. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: [phone]; e-mail address: [e-mail].

B. International Residue Limits

-There are no Codex, Canadian or Mexican maximum residue limits established for triflumizole residues in/on crop commodities. Therefore, no compatibility issues exist with regard to the proposed U.S. tolerances discussed in this risk assessment.

VI. Conclusion

Therefore, tolerances are established/revised for combined residues of triflumizole, 1- (1-((4-chloro-2-(trifluoromethyl)phenyl)imino)-2-propoxyethyl)-1H-imidazole, and its metabolites containing the 4-chloro-2-trifluoromethylaniline moiety, calculated as the parent compound, in or on parsley, leaves at 20 ppm; dandelion, leaves at 7.0 ppm; Swiss chard at 7.0 ppm; collards at 20 ppm; kale at 20 ppm; kohlrabi at 20 ppm; mustard, greens at 20 ppm; cabbage, Chinese, Napa at 20 ppm; broccoli at 1.0 ppm; coriander, leaves at 20 ppm; and turnip, greens at 20 ppm.--

VII. Statutory and Executive Order Reviews

-This final rule establishes/revises time-limited tolerances under section 408 of the FFDCA. 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 due to its lack of significance, 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). 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., or 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). 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); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). 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). Since tolerances and exemptions that are established on the basis of a FIFRA section 18 exemption under section 408 of the FFDCA, such as the [tolerance/exemption] 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. [If this rule is adopting a proposed rule add the following sentence: The Agency hereby certifies that this rule will not have significant negative economic impact on a substantial number of small entities.] In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers, and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of the FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

VIII. Congressional Review Act

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, 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

Dated: August 11, 2006.

Daniel J. Rosenblatt,

Acting Director, Registration Division, Office of Pesticide Programs.

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. Section 180.476 is amended, in paragraph (b), by revising the table to read as follows:

§ 180.476

Triflumizole; tolerances for residues.

* * * * *

(b) *  *  *   -

Commodity	Parts per million	Expiration/revocation date
Broccoli	1.0	12/31/09
Cabbage, chinese, napa	20	12/31/09
Collards	20	12/31/09
Coriander, leaves	20	12/31/09
Dandelion, leaves	7.0	12/31/09
Kale	20	12/31/09
Kohlrabi	20	12/31/09
Mustard, greens	20	12/31/09
Parsley, leaves	20	12/31/09
Swiss chard	7.0	12/31/09
Turnip, greens	20	12/31/09

* * * * *