E7-9206. Chlorantraniliprole; Time-Limited Pesticide Tolerances

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule.

SUMMARY:

This regulation establishes time-limited tolerances for residues of chlorantraniliprole in or on apple and apple, wet pomace, celery, cucumber, head and leaf lettuce, pear, pepper, spinach, squash, tomato and watermelon commodities. DuPont Crop Protection requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA). The tolerances will expire on May 1, 2010.

DATES:

This regulation is effective May 16, 2007. Objections and requests for hearings must be received on or before July 16, 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-2006-0800. 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 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 telephone number is [phone].

FOR FURTHER INFORMATION CONTACT:

Kable Bo Davis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: 703 306-0415; 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. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions discussed above. 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-2006-0800 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 July 16, 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-2006-0800, 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 telephone number is [phone].

II. Background and Statutory Findings

In the Federal Register of October 13, 2006 (71 FR 198) (FRL-8096-2), EPA issued a notice pursuant to section 408(d)(3) of the FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 6G7089) by E I. DuPont de Nemours and Company, DuPont Crop Protection, 1090 Elkton Road, Newark, Delaware 19711. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the insecticide chlorantraniliprole, 3-bromo-N-[4-chloro-2-methyl-6-[(methylamino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-carboxamide, in or on apple at 0.3 parts per million (ppm), apple, celery at 7.0 ppm, cucumber at 0.09 ppm, lettuce, head at 4.0 ppm, lettuce, leaf at 7.5 ppm, pear at 0.30 ppm, pepper at 0.50 ppm, spinach at 13.0 ppm, squash at 0.25 ppm, tomato at 0.30 ppm and watermelon at 0.20 ppm. This notice referenced a summary of the petition prepared by E.I. DuPont de Nemours and Company, DuPont Crop Protection, the registrant, which has been included in the public docket. Several comments were received from a private citizen on objecting to pesticide body load, IR-4 profiteering, animal testing, and other related matters. The Agency has received these same comments from this commenter on numerous previous occasions. Refer to the Federal Register of June 30, 2005 (70 FR 37686) (FRL-7718-3), January 7, 2005 (70 FR 1354) (FRL-7691-4), and October 29, 2004 69 FR 63096 for the Agency's response to these objections.

These temporary tolerances will permit the marketing of the above raw agricultural commodities when treated in accordance with the provisions of the experimental use permits 352-EUP-170, and 353-EUP-171, which are being issued under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended (7 U.S.C. 136).

The scientific data reported and other relevant material were evaluated, and it was determined that establishment of these temporary tolerances will protect the public health. Therefore, these temporary tolerances have been established on the condition that the pesticide be used in accordance with the experimental use permits. The tolerances will expire on May 1, 2010.

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. . . .”

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.

III. Aggregate Risk Assessment and Determination of Safety

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 and to make a determination on aggregate exposure, consistent with section 408(b)(2) of the FFDCA , for tolerances for residues of chlorantraniliprole on apple at 0.25 ppm, apple, wet pomace at 0.60 ppm, celery at 7.0 ppm, cucumber at 0.10 ppm, lettuce, head at 4.0 ppm, lettuce, leaf at 8.0 ppm, pear at 0.30 ppm, pepper at 0.50 ppm, spinach at 13.0 ppm, squash at 0.40 ppm, tomato at 0.30 ppm and watermelon at 0.20 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows.

A. Toxicological Profile

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. Specific information on the studies received and the nature of the toxic effects caused by chlorantraniliprole as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at www.regulations.gov in Docket ID EPA-HQ-OPP-2006-0800.

B. Toxicological Endpoints

For hazards that have a threshold below which there is no appreciable risk, the dose at which NOAEL from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the LOAEL of concern are identified is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor (UF) is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns.

The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify non-threshold hazards such as cancer. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk, estimates risk in terms of the probability of occurrence of additional cancer cases. More information can be found on the general principles EPA uses in risk characterization at http://www.epa.gov/​pesticides/​health/​human.htm.

A summary of the toxicological endpoints for chlorantraniliprole used for human risk assessment can be found at www.regulations.gov in Docket ID EPA-HQ-OPP-2006-0800.

C. Exposure Assessment

1. Dietary exposure from food and feed uses. Chlorantraniliprole is a new active ingredient and tolerances have not been established. A risk assessment was conducted by EPA to assess dietary exposures from chlorantraniliprole in food (from crops treated under the experimental permits) as follows:

i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a one day or single exposure. Acute dietary (food and drinking water) exposure assessments were conducted for chlorantraniliprole using the Dietary Exposure Evaluation Model (DEEM-FCID), and reflect the proposed uses on apple, celery, cucumber, head and leaf lettuce, pear, pepper, spinach, squash, tomato and watermelon crops. The modeled exposure estimates are based on tolerance level residues (calculated using the maximum residue level calculator) assuming 100% of crops are treated and surface water estimated drinking water concentrations (EDWCs) (because surface water EDWCs were higher than ground water EDWCs).

ii. Chronic exposure. Chronic dietary (food and drinking water) exposure assessments were conducted for chlorantraniliprole using the DEEM-FCID), and reflect the proposed uses on apple, celery, cucumber, head and leaf lettuce, pear, pepper, spinach, squash, tomato and watermelon crops. The modeled exposure estimates are based on tolerance level residues (calculated using the maximum residue level calculator) assuming 100% of crops are treated and surface water estimated drinking water concentrations (EDWCs) (because surface water EDWCs were higher than ground water EDWCs).

iii. Cancer. Long-term exposure is not expected to result from use under these Experimental Use Permits (EUPs). The submitted subchronic studies in mice, dog and rats, and the in vivo and in vitro genotoxicity studies, identified no tumors or preneoplastic foci, nor did they identify mutagenic concern. Therefore, the expected short/intermediate-term exposure resulting from the EUPs does not indicate a concern for carcinogenicity.

2. Dietary exposure from drinking water. Clorantraniliprole is an unregistered chemical, thus, the Agency lacks sufficient monitoring data to complete a comprehensive dietary exposure analysis and risk assessment for chlorantraniliprole in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the physical characteristics of chlorantraniliprole. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/​oppefed1/​models/​water/​index.htm.

Based on the EPA's pesticide root zone model/exposure analysis modeling system (PRZM/EXAMS) and screening concentration in groundwater (SCI-GROW) models, the estimated environmental concentrations (EECs) of chlorantraniliprole for acute exposures are estimated to be 14 ppb for surface water and 0.38 ppb for ground water. The EECs for chronic exposures are estimated to be 2.3 ppb for surface water and 0.38 for ground water.

3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets).

Chlorantraniliprole is not registered for use on any sites that would result in residential exposure.

4. Cumulative effects from substances with a common mechanism of toxicity. 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 chlorantraniliprole and any other substances and chlorantraniliprole 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 chlorantraniliprole 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 the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at http://www.epa.gov/​pesticides/​cumulative/​.

D. Safety Factor for Infants and Children

1. In general. 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 data base 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 (MOE) analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans.

2. Prenatal and postnatal sensitivity. There were no effects on fetal growth or development up to the limit dose of 1,000 milligrams killogram day (mg/kg/day) in rats or rabbits. There were no treatment related effects on the numbers of litters, fetuses (live or dead), resorptions, sex ratio, or post-implantation loss. There were no effects on fetal body weights, skeletal ossification, and external, visceral, or skeletal malformations or variations.

3. Conclusion. Due to the following, the FQPA Safety Factor does not need to be retained at this time:

The toxicology database is complete for the characterization of potential prenatal and postnatal risks to infants and children. No susceptibility was identified in the toxicological data base, and there are no residual uncertainties re: prenatal and/or postnatal exposure (i.e., the developmental and reproduction studies report no adverse effects related to treatment ≥ 1,000 mg/kg/day limit dose). Therefore, a degree of concern analysis for prenatal and/or postnatal susceptibility is not necessary.

Highly conservative dietary (food and water) exposure estimates are at least 60,000 times lower than the highest dose tested in the mammalian toxicity studies (at which no adverse observed effects were seen).

E. Aggregate Risks and Determination of Safety

1. Acute/chronic risk. Aggregating routes and/or pathways of exposure is not relevant, since no hazard was identified via any route of exposure in the EUP toxicology data base.

2. Short/Intermediate-term risk. Chlorantraniliprole is not registered for use on any sites that would result in short and intermediate residential exposure and therefore no risk assessment was conducted for this scenario.

3. Aggregate cancer risk for U.S. population. Long-term exposure is not expected to result from use under these EUPs. The submitted subchronic studies in mice, dog and rats, and the in vivo and in vitro genotoxicity studies, identified no tumors or preneoplastic foci, nor did they identify mutagenic concern.

4. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to chlorantraniliprole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

LC/MS/MS methods are available for measuring chlorantraniliprole in plants and livestock. The registrant submitted an LC/MS/MS method for the determination of chlorantraniliprole in plants, and an LC/MS/MS method for the determination of chlorantraniliprole and its metabolites in livestock.

Adequate method and concurrent recovery data were provided for the plant LC/MS/MS method, and the fortification levels used in the method and concurrent validation are adequate to bracket the residue levels determined in the proposed crops. An analytical method for enforcing tolerances in livestock commodities is not germane to this EUP as tolerances in meat, milk, poultry and eggs are not required.

B. International Residue Limits

There are currently no established Codex, Canadian, or Mexican MRLs for chlorantraniliprole.

C. Conditions

None.

V. Conclusion

Therefore, time-limited tolerances are established for residues of chlorantraniliprole, 3-bromo-N-[4-chloro-2-methyl-6-[(methylamino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-carboxamide, in or on apple at 0.25 ppm, apple, wet pomace at 0.60 ppm, celery at 7.0 ppm, cucumber at 0.10 ppm, lettuce, head at 4.0 ppm, lettuce, leaf at 8.0 ppm, pear at 0.30 ppm, pepper at 0.50 ppm, spinach at 13.0 ppm, squash at 0.40 ppm, tomato at 0.30 ppm and watermelon at 0.20 ppm. These tolerances will expire on May 1, 2010.

VI. Statutory and Executive Order Reviews

This final rule establishes a tolerance 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).

VII. 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

Dated: May 2, 2007.

Debra Edwards,

Director, 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 180.628 is added to read as follows:

§180.628

Chlorantraniliprole; tolerances for residues.

(a) Tolerances are established for residues of the pesticide chlorantraniliprole (3-bromo-N-[4-chloro-2-methyl-6-[(methylamino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-carboxamide) in or on the following raw agricultural commodities:

Commodity	Parts per million	Expiration/revocation date
Apple	0.25	05/01/2010
Apple, wet pomace	0.60	05/01/2010
Celery	7.0	05/01/2010
Cucumber	0.10	05/01/2010
Lettuce, head	4.0	05/01/2010
Lettuce, leaf	8.0	05/01/2010
Pear	0.30	05/01/2010
Pepper	0.50	05/01/2010
Spinach	13.0	05/01/2010
Squash	0.40	05/01/2010
Tomato	0.30	05/01/2010
Watermelon	0.20	05/01/2010

(b) Section 18 emergency exemptions. [Reserved]

(c) Tolerances with regional registrations. [Reserved]

(d) Indirect or inadvertent residues. [Reserved]