Pesticides; tolerances in food, animal feeds, and raw agricultural commodities: Pyriproxyfen,
[Federal Register: August 22, 2007 (Volume 72, Number 162)]
[Rules and Regulations]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Pyriproxyfen; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes tolerances for residues of pyriproxyfen in or on animal feed, nongrass, group 18, forage; animal feed, nongrass, group 18, hay; animal feed, nongrass, group 18, seed; banana; beet, sugar, dried pulp; cacao bean, dried; caneberry, subgroup 13-A; canola, seed; coffee, instant; coffee, green bean; cranberry; date; grain, cereal, group 15; grain, cereal, forage, fodder and straw, group 16; pawpaw; peanut; pineapple; pineapple, process residue; pomegranate; potato, chips; potato, granules/flakes; potato, wet peel; rice, hulls; safflower, seed; sesame, seed; sugarcane; tea; vegetable, bulb, group 3, except onion, bulb; and vegetable, root and tuber, group 1. Interregional Research Project Number 4 (IR-4), 500 College Road East, Suite 201 W, Princeton, NJ 08540 requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective August 22, 2007. Objections and requests for hearings must be received on or before October 22, 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-2006-0889. 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 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: Shaja R. Brothers, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460- 0001; telephone number: (703) 308-3194; e-mail address: firstname.lastname@example.org.
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 those engaged in the following activities:
Crop production (NAICS code 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers.
Animal production (NAICS code 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS code 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators.
Pesticide manufacturing (NAICS code 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users.
This listing is not intended to be exhaustive, but rather to provide 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.
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 EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr.
Can I File an Objection or Hearing Request?
Under section 408(g) of the FFDCA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. 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-2006-0889 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 as required by 40 CFR part 178 on or before October 22, 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 this copy, identified by docket ID number EPA-HQ-OPP-2006-0889, 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.
Petition for Tolerance
In the Federal Register of November 22, 2006 (71 FR 67571) (FRL- 8102-2), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 6E7003) by IR-4, 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40 CFR 180.510 be amended by establishing tolerances for residues of the insecticide, pyriproxyfen, 2-1-methyl-2-(4-phenoxyphenoxy)ethoxypyridine, in or on vegetable, root and tuber, group 1 at 0.15 part per million (ppm); vegetable, leaves of root and tuber, group 2 at 2.0 ppm; vegetable, bulb, group 3, except onion, dry bulb at 0.70 ppm; vegetable, leafy, except brassica, group 4 at 2.0 ppm; vegetable, legume, group 6 at 0.2 ppm; vegetable, foliage of legume, group 7 at 2.0 ppm; caneberry, subgroup 13A at 1.0 ppm; grain, cereal, group 15 at 1.1 ppm; grain, cereal, forage, fodder and straw, group 16 at 1.1 ppm; animal feed, nongrass, group 18 at 0.7 ppm for forage, 2.0 for seed, and 1.1 for hay; asparagus at 2.0 ppm; banana and plantain at 0.2 ppm; cacao bean at 0.02 ppm; canola, seed at 0.20 ppm; coffee at 0.02 ppm; cranberry at 1.0 ppm; date at 0.3 ppm; grass, forage at 0.5 ppm; grass, hay at 1.0 ppm; kiwifruit at 0.1 ppm; pawpaw at 1.0 ppm; peanut at 0.2 ppm; pineapple at 0.3 ppm; pomegranate at 0.20 ppm; safflower, seed at 0.2 ppm; sesame, seed at 0.02 ppm; sugarcane at 1.1 ppm; tea at 0.02 ppm; watercress at 2.0 ppm; and artichoke, globe at 2.0 ppm. That notice referenced a summary of the petition prepared by Valent USA Corporation, the registrant, which is available to the public in the docket, http://www.regulations.gov. One
comment was received on the notice of filing. EPA's response to comment is discussed in Unit IV.C.
Based upon review of the data supporting the petition, EPA has determined that proposed tolerances for vegetable, leaves of root, and tuber, group 2; vegetable, leafy, except, Brassica, group 4; vegetable, legume, group 6; vegetable, foliage of legume, group 7; artichoke, globe; asparagus; kiwifruit; and watercress will not be established at this time. Further, the Agency is establishing the following additional tolerances in conjunction with the tolerances that were requested: Beet, sugar, dried, pulp; potato, granules/flakes; potato, chips; potato, wet peel; rice, hulls; coffee, instant; and pineapple, process residue. The reason for these changes is explained in Unit IV.
Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide pyriproxyfen 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 pyriproxyfen 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 pyriproxyfen 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 pyriproxyfen residue....'' These provisions were added to the FFDCA by the Food Quality Protection Act (FQPA) of 1996.
Consistent with FFDCA section 408(b)(2)(D), and the factors specified in section 408(b)(2)(D), 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 for the petitioned-for tolerances for residues of pyriproxyfen on animal feed, nongrass, group 18, forage at 0.70 ppm; animal feed, nongrass, group 18, hay at 1.1 ppm; animal feed, nongrass, group 18, seed at 2.0 ppm; banana at 0.20 ppm; beet, sugar, dried pulp at 3.0 ppm; cacao bean, dried at 0.02 ppm; caneberry, subgroup 13-A at 1.0 ppm; canola, seed at 0.20 ppm; coffee, instant at 0.10 ppm; coffee, green bean at 0.02 ppm; cranberry at 1.0 ppm; date at 0.30 ppm; grain, cereal, group 15 at 1.1 ppm; grain, cereal, forage, fodder and straw, group 16 at 1.1 ppm; pawpaw at 1.0 ppm; peanut at 0.20 ppm; pineapple at 0.30 ppm; pineapple, process residue at 1.1 ppm; pomegranate at 0.20 ppm; potato, chips at 0.75 ppm; potato, granules/ flakes at 0.75 ppm; potato, wet peel at 0.75 ppm; rice, hulls at 5.5 ppm; safflower, seed at 0.20 ppm; sesame, seed at 0.02 ppm; sugarcane at 1.1 ppm; tea at 0.02 ppm; vegetable, bulb, group 3, except onion, bulb at 0.70 ppm; and vegetable, root and tuber, group 1 at 0.15 ppm. EPA's assessment of exposures and risks associated with establishing the tolerances follow.
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 adverse effects caused by pyriproxyfen 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 http://www.epa.gov/fedrgstr/EPA-PEST/2003/May/Day-14/p12022.htm in Federal
Register of May 14, 2003 (68 FR 25831) (FRL-7305-9).
For hazards that have a threshold below which there is no appreciable risk, the toxicological level of concern (LOC) is derived from the highest dose at which no adverse effects are observed (the NOAEL) in the toxicology study identified as appropriate for use in risk assessment. However, if a NOAEL cannot be determined, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment. Uncertainty/safety factors (UF) are used in conjunction with the LOC to take into account 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. Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the acute population adjusted dose (``aPAD'') and chronic population adjusted dose (``cPAD''). The aPAD and cPAD are calculated by dividing the LOC by all applicable uncertainty/safety factors. Short-, intermediate, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the margin of exposure (``MOE'') called for by the product of all applicable uncertainty/safety factors is not exceeded.
For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk and estimates risk in terms of the probability of occurrence of additional adverse cases. Generally, cancer risks are considered non-threshold. For more information on the general principles
EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm .
A summary of the toxicological endpoints for pyriproxyfen used for human risk assessment can be found at http://www.regulations.gov in document
title Pyriproxyfen Human Health Risk Assessment Use on Numerous Crops. IR-4 Tolerance Plan (Reduced Data Set Translations) on pages 9-10 in Docket ID EPA-HQ-OPP-2006-0889.
Dietary exposure from food and feed uses. In evaluating dietary exposure to pyriproxyfen, EPA considered exposure under the petitioned- for tolerances as well as all existing pyriproxyfen tolerances in (40 CFR 180.510). EPA assessed dietary exposures from pyriproxyfen in food 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. No such effects were identified in the toxicological studies for pyriproxyfen; therefore, a quantitative acute dietary exposure assessment is unnecessary.
ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA performed a Tier 1 chronic analysis which assumed 100% crop treated (CT), default processing factors, and tolerance level residues for all commodities.
iii. Cancer. A cancer dietary risk assessment was not performed because no evidence of carcinogenicity has been found for pyriproxyfen.
Dietary exposure from drinking water. The Agency lacks sufficient monitoring data to complete a comprehensive dietary exposure analysis and risk assessment for pyriproxyfen 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 environmental fate characteristics of pyriproxyfen. 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 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 pyriproxyfen for acute and chronic exposures for surface water are estimated to be 2.15 parts per billion (ppb), and 0.40 ppb, respectively. The EEC for chronic exposure is estimated to be 0.006 ppb for groundwater. Both models assumed a maximum seasonal application rate of 0.11 lb ai/A, 3 times per year (citrus and stone fruit).
Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic dietary risk assessment, the water concentration of value 0.40 ppb was used to access the contribution to drinking water.
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).
Pyriproxyfen is the active ingredient in many registered residential products for flea and tick control (home environment and pet treatments) as well as products for ant and roach control (indoor and outdoor applications). Formulations include carpet powders, foggers, aerosol sprays, liquids (shampoos, sprays and pipettes for pet treatments), granules, bait (indoor and outdoor), and impregnated materials (pet collars). Only a post-application residential assessment was conducted as the Agency did not select any short-term dermal or inhalation endpoints. Toddlers are anticipated to have the highest exposures from treated home environments and pets due to typical hand- to-mouth behavior. EPA assessed residential exposure using the following assumptions:
Short-term, intermediate-term, and long-term toddler hand- to-mouth exposures (consisting of petting treated animals and touching treated carpets/flooring). Long-term dermal exposures for products with anticipated efficacy more than 6 months (carpet powders and pet collars).
Combined treatment toddler exposure scenarios as a result of treatments to the home environment and the pet in the same period (such as carpet powder and pet shampoo treatments). Episodic ingestion of granules by toddlers is anticipated, but an assessment for this scenario is not included, since an acute dietary endpoint was not selected.
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 pyriproxyfen and any other substances and pyriproxyfen 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 pyriproxyfen 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 .
Safety Factor for Infants and Children
In general. Section 408 of FFDCA provides that EPA shall apply an additional (``10X'') 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 based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA safety factor. In applying this provision, EPA either retains the default value of 10X when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional FQPA safety factor value based on the use of traditional uncertainty/safety factors and/or special FQPA safety factors, as appropriate.
Prenatal and postnatal sensitivity. Based on the available data, there is no quantitative and qualitative evidence of increased susceptibility observed following in utero pyriproxyfen exposure to rats and rabbits or following prenatal/postnatal exposure in the 2- generation reproduction study.
Conclusion. EPA has determined that reliable data show that it would be safe for infants and children to reduce the FQPA safety factor to 1X. That decision is based on the following findings:
i. The toxicity database for pyriproxyfen is complete.
ii. There is no indication that pyriproxyfen is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional uncertainty factors to account for neurotoxicity.
iii. There is no evidence that pyriproxyfen results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study.
iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100% CT and tolerance-level residues. Conservative ground water and surface water modeling estimates were used. Similarly conservative Residential Standard Operating Procedues (SOPs) were used to assess post-application exposure to children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by pyriproxyfen.
Aggregate Risks and Determination of Safety
Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and cPAD are calculated by dividing the LOC by all applicable uncertainty/ safety factors. For linear cancer risks, EPA calculates the probability of additional cancer cases given aggregate exposure. Short-term, intermediate-term, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the MOE called for by the product of all applicable uncertainty/safety factors is not exceeded.
Acute risk. No such effects were identified in the toxicological studies for pyriproxyfen; therefore, a quantitative acute risk assessment is unnecessary.
Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to pyriproxyfen from food and water will utilize 10% of the cPAD for the population group children 1-2 years old. A long-term post-application residential assessment was performed for toddlers only since they are anticipated to have the higher exposures than adults from treated home environments and pets due to their behavior patterns. The total chronic dietary and residential aggregate MOEs range from 570 to 4,700.
Short-term and intermediate-term risk. Short and intermediate- term aggregate exposures take into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Pyriproxyfen is currently registered for use that could result in short-term and intermediate-term residential exposures and the Agency has determined that it is appropriate to aggregate chronic food and water for short-term and intermediate-term exposures for pyriproxyfen.
Using the exposure assumptions described in this unit for short- term exposures, EPA has concluded that food, water, and residential exposures aggregated result in aggregate MOEs range from 1,200 to 14,000 for children 1-2 years old, and females 13-49 years old, respectively.
Using the exposure assumptions described in this unit for intermediate-term exposures, EPA has concluded that food, water, and residential exposures aggregated result in aggregate MOEs range from 430 to 4,700 for children 1-2 years old, and females 13-49 years old, respectively.
Aggregate cancer risk for U.S. population. Pyriproxyfen is classified as a ``Group E'' chemical (negative for carcinogenicity to humans). This classification is based on the lack of evidence of carcinogenicity in mice and rats. EPA does not expect pyriproxyfen to pose a cancer risk.
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, or to infants and children from aggregate exposure to pyriproxyfen residues.
Analytical Enforcement Methodology
Adequate enforcement methodology (gas chromatography/nitrogen- phosphorous detector (GC/NPD)) is available to enforce the tolerance 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: email@example.com.
International Residue Limits
There are currently no established Codex maximum residue limits (MRLs) for pyriproxyfen.
Response to Comments
One comment was received by the Agency from a private citizen. The comment applies to the use of ``available data'' concerning the cumulative effects of the pesticide's residues and ``other substances that have a common mechanism of toxicity.'' In this case, EPA did not assume that this chemical has a common mechanism of toxicity with other substances as the chemical does not generate metabolites produced also by other chemicals. For specific information regarding EPA's approach to the use of common mechanism of toxicity to evaluate the cumulative effects of chemicals, please refer to EPA's website at http://www.epa.gov/pesticides/cumulative/ to see policy statements.
Following review of the residue data submitted with the petition, EPA has made several revisions to the petition's request for the establishment of tolerances. First, due to absence of confirmatory data, the Agency is not establishing in this regulation the tolerances proposed for vegetable, leaves of root, and tuber, group 2; vegetable, leafy, except, Brassica, group 4; vegetable, legume, group 6; vegetable, foliage of legume, group 7; artichoke, globe; asparagus; kiwifruit; and watercress at this time. Second, EPA determined that proposed tolerances for various raw agricultural commodities (beets, potatoes, rice, coffee, pineapples) did not appropriately address residue levels that could occur in foods processed from those raw commodities. Accordingly, relying on the theoretical processing factors or processing factors from the Agency's pyriproxyfen database, EPA is establishing tolerances for the processed commodities of beet, dry pulp; potato granules/flakes, chips, and wet peel; rice, hulls; coffee, instant; and pineapple processed residue.
Therefore, tolerances are established for residues of pyriproxyfen, 2-[1-methyl-2-(4-phenoxyphenoxy)ethoxypyridine, in or on the commodities listed in Unit III. paragraph 2.
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).
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: August 9, 2007. Donald R. Stubbs, Acting Director, Registration Division, Office of Pesticide Programs.
0 Therefore, 40 CFR chapter I is amended as follows:
0 1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0 2. Section 180.510 is amended by alphabetically adding the following commodities to the table in paragraph (a)(1) to read as follows:
Sec. 180.510 Pyriproxyfen; tolerances for residues.
(a) * * *
(1) * * *
Parts per million
* * * * * Animal feed, nongrass, group 18,
Animal feed, nongrass, group 18, hay
Animal feed, nongrass, group 18,
* * * * * Banana
Beet, sugar, dried pulp
* * * * * Cacao bean, dried
Caneberry, subgroup 13-A
* * * * * Coffee, instant
Coffee, green bean
* * * * * Cranberry
* * * * * Date
* * * * * Grain, cereal, group 15
Grain, cereal, forage, fodder and
1.1 straw, group 16
* * * * * Pawpaw
Pineapple, process residue
* * * * * Pomegranate
Potato, wet peel
* * * * * Rice, hulls
* * * * * Safflower, seed
* * * * * Sesame, seed
Vegetable, bulb, group 3, except
0.70 onion, bulb
Vegetable, root and tuber, group 1..
* * * * *
[FR Doc. E7-16310 Filed 8-21-07; 8:45 am]
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