Pesticides; tolerances in food, animal feeds, and raw agricultural commodities: Pyriproxyfen,
[Federal Register: March 7, 2003 (Volume 68, Number 45)]
[Rules and Regulations]
[Page 10972-10982]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07mr03-10]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2002-0345; FRL-7289-6]
Pyriproxyfen; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes a tolerance for residues of pyriproxyfen in or on Brassica, head and stem, subgroup 5A, Brassica, leafy greens, subgroup 5B, vegetable, cucurbit group 9, olives and olive oil. Valent U.S.A. Corporation requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA).
DATES: This regulation is effective March 7, 2003. Objections and requests for hearings, identified by docket ID number OPP-2002-0345, must be received on or before May 6, 2003.
ADDRESSES: Written objections and hearing requests may be submitted electronically, by mail, or through hand delivery/courier. Follow the detailed instructions as provided in Unit VI. of the SUPPLEMENTARY INFORMATION.
FOR FURTHER INFORMATION CONTACT: Joseph M. Tavano, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460- 0001; telephone number: (703) 305-6411; e-mail address: tavano.joseph@epa.gov.
SUPPLEMENTARY INFORMATION:
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General Information
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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:
[sbull] Industry (NAICS 111), Crop production.
[sbull] Industry (NAICS 112), Animal production.-
[sbull] Industry (NAICS 311), Food manufacturing
[sbull] Industry (NAICS 32532), Pesticide manufacturing--
This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be
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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.
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How Can I Get Copies of this Document and Other Related Information? -
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Docket. EPA has established an official public docket for this action under docket identification (ID) number OPP-2002-0345 The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 305-5805.-
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Electronic access. You may access this Federal Register document electronically through the EPA Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/. A frequently updated
listings at http://www.epa.gov/fedrgstr/. A frequently updated
electronic version of 40 CFR part 180 is available at http:// www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html , a
www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a
beta site currently under development. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm.-
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B.1. Once in the system, select ``search,'' then key in the appropriate docket ID number. -
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Background and Statutory Findings-
In the Federal Register of May 29, 2002 (67 FR 37426-37432) (FRL- 7178-3), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a, as amended by FQPA (Public Law 104-170), announcing the filing of a pesticide petition PP 2F6385 by Valent U.S.A. Corporation, 1333 North California Blvd., Suite 600, P.O. Box 8025, Walnut Creek, CA 94596-8025. That notice included a summary of the petition prepared by Valent U.S.A. Corporation. the registrant. There were no comments received in response to the notice of filing.-
The petition requested that 40 CFR 180.510 be amended by establishing a tolerance for residues of the insecticide, pyriproxyfen, 2-[1-methyl-2-(4-phenoxyphenoxy)ethoxypyridine, in or on Brassica leafy vegetables (Crop Group 5); vegetable, cucurbit (Crop Group 9); olive and olive, oil at 2.5, 0.1, 1.0, and 3.0 parts per million (ppm) respectively.
Based on the residue data submitted, EPA has determined that the following changes to the requested tolerances listed in this document are necessary. A lower tolerance of 2.0 ppm is required for olive, oil. Brassica vegetables are devided into two subgroups. A tolerance of 0.70 is required for Brassica, head and stem, subgroup 5A. A tolerance of 2.0 ppm is required for Brassica, leafy greens, subgroup 5B.-
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 the final rule on Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL- 5754-7).
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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 a tolerance for residues of pyriproxyfen on Brassica, head and stem, subgroup 5A; Brassica, leafy greens, subgroup 5B; Vegetable, cucurbit (Group 9); olive and olive, oil at 0.70, 2.0, 0.10, 1.0, and 2.0 ppm, respectively. EPA's assessment of exposures and risks associated with establishing the tolerance follows.
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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. The nature of the toxic effects caused by pyriproxyfen are discussed in Table 1 of this unit as well as the no-observed-adverse- effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies reviewed.
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Table 1.--Toxicity Profile of Pyriproxyfen Technical
MRID No. (year)/ Guideline No./Study Type
Classification /Doses
Results
870.3100
43210504 (1990) Acceptable/ NOAEL = 149.4 mg/kg/day in males (M), 90-Day oral toxicity rodents-- mouse.... guideline
196.5 mg/kg/day in females (F) 0; 200; 1,000; 5,000; or LOAEL = 838.1 mg/kg/day (M), 963.9 mg/kg/ 10,000 ppm.
day (F) based on pathological changes in M: 0, 28.2, 149.4, 838.1, the kidney, increased absolute and or 2,034.5 milligram/
relative (to body) liver weight, kilogram/day (mg/kg/day). decreased red blood cell parameters F: 0, 37.9, 196.5, 963.9, (both sexes), and decreased body weight or 2,345.3 mg/kg/day.
gain (M)
870.3100
41321716 (1989) Acceptable/ NOAEL = 23.49 mg/kg/day (M), 27.68 mg/kg/ 90-Day oral toxicity rodents--rat....... guideline
day (F) 0; 400; 2,000; 5,000; or LOAEL = 117.79 mg/kg/day (M), 141.28 10,000 ppm.
based on increased total cholesterol and M: 0, 23.49, 117.79,
phospholipids (M),decreased red blood 309.05, or 641.81 mg/kg/ cell, hematocrit, and hemoglobin counts, day.
increased relative (to body) liver F: 0, 27.68, 141.28,
weight (M), and negative trend in red 356.30, or 783.96 mg/kg/ blood cell volume (F) day.
870.3150
42178307 (1988) Acceptable/ NOAEL = 100 mg/kg/day (M) and (F) 90-Day oral toxicity non-rodents--dog... guideline
LOAEL = 300 mg/kg/day (M) and (F) based 0, 100, 300, or 1,000 mg/kg/ on increased absolute and relative (to day.
body) liver weight (both sexes), and hepatocyte enlargement (F)
870.3200
43994102 (1993) Acceptable/ NOAEL = 1,000 mg/kg/day (M) and (F) 21-Day dermal toxicity--rat............. guideline
LOAEL = not established 0, 100, 300, or 1,000 mg/kg/ day.
870.3265
42178308 (1988)
NOAEL = 0.482 mg/L (M) and (F) 28-Day inhalation toxicity--rat......... Supplementary
LOAEL = 1.000 mg/L based on salivation 0, 269, 482, or 1,000 mg/ (both sexes), sporadic decreased body meter cubed (m\3\).
weight (M), and increased lactate 0, 0.269, 0.482, or 1.000 dehydrogenase (M) mg/liter (L).
870.3700a
44985002 (1988) Acceptable/ Parental NOAEL = 100 mg/kg/day Prenatal developmental--rats (non-
nonguideline
Parental LOAEL = 300 mg/kg/day based on guideline).
0, 100, 300, 500, or 1,000 clinical signs, decreased body weight mg/kg/day.
gains, increased water consumption (both sexes) and increased food consumption, changes in organ weights, and gross pathological changes (M) Developmental NOAEL = 1,000 mg/kg/day highest dose tested (HDT)
870.3700a
44985001 (1988) Acceptable/ Maternal NOAEL = 100 mg/kg/day Prenatal developmental--rats (non-
nonguideline
Maternal LOAEL = 300 mg/kg/day based on guideline).
0, 30, 100, 300, or 500 mg/ clinical signs, decreased body weight kg/day.
gains, and decreased food consumption Developmental NOAEL = 100 mg/kg/day Developmental LOAEL = 300 mg/kg/day based on decreased body weight and increased incidence of dilation of the renal pelvis.
870.3700b Prenatal developmental--rabbit 41321720, 42178311,
Maternal NOAEL = 100 mg/kg/day 43215401, 43215402,
Maternal LOAEL = 300 mg/kg/day based on 43215403 (1989) Acceptable/ premature delivery/abortions, soft guideline
stools, emaciation, lusterless fur, 0, 100, 300, or 1,000 mg/kg/ decreased activity, and bradypnea. day.
Developmental NOAEL = 300 mg/kg/day Developmental LOAEL = 1,000 mg/kg/day based on decreased viable litters available for evaluation
870.3700a
42178312 (1988) Acceptable/ Maternal NOAEL = 100 mg/kg/day Prenatal developmental--rat............. guideline
Maternal LOAEL = 300 mg/kg/day based on 0, 100, 300, or 1,000 mg/kg/ decreased body weight, body weight gain, day.
and food consumption and increased water consumption . Developmental NOAEL = 300 mg/kg/day Developmental LOAEL = 1,000 mg/kg/day based on increased incidence of skeletal variations at gestation day 21 and unspecified visceral variations at postnatal day (PND) 56.
870.3800
42178313 (1991) Acceptable/ Parental/Systemic NOAEL = 87 mg/kg/day Reproduction and fertility effects-- rat guideline
(M), 96 mg/kg/day (F) 0; 200; 1,000; or 5,000 ppm Parental/Systemic LOAEL = 453 mg/kg/day M: 0, 18, 87, or 453 mg/kg/ (M), 498 mg/kg/day (F) based on day.
decreased body weight, body weight gain, F: 0, 20, 96, or 498 mg/kg/ and food consumption (both sexes) and day.
increased liver weight (both sexes) and histopathological lesions of liver and kidneys (M) Reproductive NOAEL = 453 mg/kg/day (M), 498 mg/kg/day (F) Reproductive LOAEL = not established. Offspring NOAEL = 87 mg/kg/day (M), 96 mg/ kg/day (F) Offspring LOAEL = 453 mg/kg/day (M), 498 mg/kg/day (F) based on decreased body weight on lactation days 14 and 21
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870.4100b
42178309 (1991) Acceptable/ NOAEL = 100 mg/kg/day (M) and (F) Chronic toxicity--dogs.................. guideline
LOAEL = 300 mg/kg/day (M), 300 mg/kg/day 0, 30, 100, 300, or 1,000 (F) based on decreased body weight gain mg/kg/day.
and increased relative liver weight (both sexes) and increased cholesterol and triglycerides and decreased red cell counts and hemoglobin in males
870.4300
42178314, 43210501,
NOAEL = 138 mg/kg/day (M), 35.1 mg/kg/day Chronic/Carcinogenicity--rats........... 43210502, 43210503 (1991) (F) Acceptable/guideline
LOAEL = not established in males, 182.7 0, 120, 600, or 3,000 ppm.. mg/kg/day (F) based on decreases in body M: 0, 5.42, 27.31, or 138.0 weight gain mg/kg/day.
No evidence of carcinogenicity F: 0, 7.04, 35.1, or 182.7 mg/kg/day.
870.4200
42178310 (1991) Acceptable/ NOAEL = 84 mg/kg/day (M), 109.5 mg/kg/day Carcinogenicity--mice................... guideline
(F) 0, 120, 600, or 3,000 ppm.. LOAEL = 420 mg/kg/day (M), 547 mg/kg/day M: 0, 16.8, 84.0, or 420 mg/ (F) based on renal lesions (M) and (F) kg/day.
No evidence of carcinogenicity F: 0, 21.9, 109.5, or 547 mg/kg/day.
870.5265
44503506 (1995) Acceptable/ Non-mutagenic when tested up to 5,000 Gene mutation........................... guideline
micrograms (mg)/plate or cytotoxic levels, in presence and absence of activation; in S. typhimurium strains TA98, TA100, TA1535, and TA1537; and in E.coli strain WP2uvra with 2-OH-PY (metabolite of pyriproxyfen).
870.5265
44503507 (1993) Acceptable/ Non-mutagenic when tested up to 5,000 mg/ Gene mutation........................... guideline
plate or cytotoxic levels, in presence and absence of activation; in S. typhimurium strains TA98, TA100, TA1535, and TA1537; and in E.coli strain WP2uvra with 4'--OH-PY, 5'--OH-PYR, DPH-PYR, POPA, and PYPAC (metabolites of pyriproxyfen).
870.5265
44503508 (1995) Acceptable/ Non-mutagenic when tested up to 5,000 mg/ Gene mutation........................... guideline
plate or cytotoxic levels, in presence and absence of activation; in S. typhimurium strains TA98, TA100, TA1535, and TA1537; and in E.coli strain WP2uvra with 2,5-OH-PY (metabolite of pyriproxyfen).
870.5265
42178315 (1988) Acceptable/ Non-mutagenic when tested up to 5,000 mg/ Gene mutation........................... guideline
plate or cytotoxic levels, in presence and absence of activation; in S. typhimurium strains TA98, TA100, TA1535, TA1537, and TA1538; and in E.coli strain WP2uvra with 2-OH-PY (pyriproxyfen technical).
870.5300
42178316 (1990) Acceptable/ Non-mutagenic at the HGPRT locus in Gene mutation........................... guideline
Chinese hamster lung V79 cells tested up to cytotoxic concentrations or limit of solubility, in presence and absence of activation.
870.5375
41321722 (1989) Acceptable/ Did not induce structural chromosome Chromosome aberration................... guideline
aberration in Chinese hamster ovary (CHO) cell cultures in the absence or presence of activation.
870.5550
42178317 (1988) Acceptable/ There was no evidence that unscheduled Unscheduled DNA synthesis............... guideline
DNA synthesis, as determined by radioactive tracer procedures (nuclear silver grain counts) was induced in HeLa cells exposed up to cytotoxic levels, both in the presence or absence of S-9.
870.7485Metabolism and pharmacokinetics-- 42178318 (1988) Acceptable/ Rats were orally dosed with \14\C-labeled rat
guideline
pyriproxyfen at 2 or 1,000 mg/kg and at repeated oral doses (14 daily doses) of unlabeled pyriproxyfen at 2 mg/kg followed by administration of a single oral dose of labeled pyriproxyfen at 2 mg/kg. Most radioactivity was excreted in the feces (81-92%) and urine (5-12%) over a 7 day collection period. Expired air containing CO2was not detected. Tissue radioactivity levels were very low (less than 0.3%) except for fat. Examination of urine, feces, liver, kidney, bile, and blood metabolites yielded numerous (> 20) identified metabolites when compared to synthetic standards. The major biotransformation reactions of pyriproxyfen include: 1. Oxidation of the 4'-- position of the terminal phenyl group. 2. Oxidation at the 5'--position of pyridine. 3. Cleavage of the ether linkage and conjugation of the resultant phenols with sulfuric acid.-
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Toxicological Endpoints-
The dose at which no adverse effects are observed (the 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 lowest dose at which adverse effects of concern are identified (the LOAEL) 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. An UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intra species differences. -
For dietary risk assessment (other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose (acute RfD or chronic RfD) where the RfD is equal to the NOAEL divided by the appropriate UF (RfD = NOAEL/UF). Where an additional safety factors (SF) is retained due to concerns unique to the FQPA, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to accommodate this type of FQPA SF.-
For non-dietary risk assessments (other than cancer) the UF is used to determine the LOC. For example, when 100 is the appropriate UF (10X to account for interspecies differences and 10X for intraspecies differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and compared to the LOC.
A summary of the toxicological endpoints for pyriproxyfen used for human risk assessment is shown in Table 2 of this unit:
Table 2.--Summary of Toxicological Dose and Endpoints for pyriproxyfen for Use in Human Risk Assessment
Dose Used in Risk FQPA SF and LOC for Study and Toxicological Exposure Scenario
Assessment, UF
Risk Assessment
Effects
Acute Dietary
None
None
An appropriate endpoint females 13-50 years old and general
attributable to a population.
single oral dose was not available in the data base, including maternal toxicity in the developmental toxicity studies.
Chronic Dietary
NOAEL= 35.1 mg/kg/day FQPA SF = 1X
Subchronic toxicity and all populations...................... UF = 100............... cPAD = cRfD / FQPA SF = chronic toxicity Chronic RfD = 0.35 mg/ 0.35 mg/kg/day.
(feeding)--rat kg/day.
(co-critical) LOAEL = 141.28 mg/kg/ day based on decreased body weight and clinical pathology results.
Short-Term Incidental, Oral (1-30 Oral Maternal NOAEL = LOC for MOE = 100
Rat developmental days)
100 mg/kg/day
toxicity study Residential..........................
Maternal LOAEL = 300 mg/ kg/day based on decreased body weight, body weight gain, and food consumption, and increased water consumption
Intermediate-Term Incidental, Oral (1- Oral NOAEL = 35.1 mg/kg/ LOC for MOE = 100
Subchronic toxicity and 6 months)
day
chronic toxicity Residential..........................
(feeding)--rat (co-critical) LOAEL = 141.28 mg/kg/ day based on decreased body weight and clinical pathology results.
Short-, and Intermediate-Term Dermal None
None
Based on the systemic (1-30 days and 1-6 months)
toxicity NOAEL of (Occupational/Residential)...........
1,000 mg/kg/day (limit dose) in the 21 day dermal toxicity study in rats, quantification of dermal risks is not required. In addition, no developmental concerns (toxicity) were seen in either rats or rabbits.
Long-Term Dermal (6 months-lifetime) Oral NOAEL= 35.1 mg/kg/ LOC for MOE = 100
Subchronic and chronic (Occupational/Residential)........... day (dermal absorption
toxicity (feeding)-- rate = 30%)
rat (co-critical) LOAEL = 141.28 mg/kg/ day based decreased body weight and clinical pathology results
Short-, and Intermediate-Term
None
None
Based on the absence of Inhalation (1-30 days and 1-6
significant toxicity months)
at the LOAEL of 1.0 mg/ (Occupational/Residential)...........
L (limit dose), the quantification of inhalation risks is not required. In addition, no developmental concerns (toxicity) were seen in either rats or rabbits.
Long-Term Inhalation (6 months-
Oral study NOAEL= 35.1 LOC for MOE = 100
Subchronic and chronic lifetime)
mg/kg/day
toxicity (feeding)-- (Occupational/Residential)........... (inhalation absorption
rat rate = 100%).
(co-critical) LOAEL = 141.28 mg/kg/ day based on decreased body weight and clinical pathology results
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Cancer (oral, dermal, inhalation) Cancer classification Risk Assessment not No evidence of (``Group E'')
required
carcinogenicity
\1\ UF = uncertainty factor, FQPA SF = Food Quality Protection Act safety factor, NOAEL = no-observed-adverse- effect-level, LOAEL = lowest-observed-adverse-effect-level, PAD = population adjusted dose (a = acute, c = chronic) RfD = reference dose, LOC = level of concern, MOE = margin of exposure \*\ The reference to the FQPA SF refers to any additional SF retained due to concerns unique to the FQPA.
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Exposure Assessment
-1. Dietary exposure from food and feed uses. Tolerances have been established (40 CFR 180.510) for the residues of pyriproxyfen, in or on a variety of raw agricultural commodities. Risk assessments were conducted by EPA to assess dietary exposures from pyriproxyfen in food as follows:
-i. Acute exposure. Acute dietary 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 1-day or single exposure. An aRfD for females 13-50 years old and the general population, including infants and children, was not selected because an acute oral endpoint attributed to a single-dose exposure could not be identified in any of the toxicology data base, including maternal toxicity in the developmental toxicity studies. Thus, the risk from acute exposure is considered negligible.
-ii. Chronic exposure. In conducting this chronic dietary risk assessment the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID\TM\), version 1.3 analysis evaluated the individual food consumption as reported by respondents in the United States Department of Agricluture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments:
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A tier 1 (assumptions: Tolerance level residues and 100 percent crop treated (PCT) was conducted.
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The established tolerances of 40 CFR 180.510 and the new tolerances established in this document were included in the analysis.
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Anticipated residues and PCT were not used in this analysis.
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The processing factors applied were the DEEM default values.
For chronic dietary risk, EPA's level of concern is >100% cPAD. Dietary exposure estimates for representative population subgroups are presented in Table 3 of this unit. The results of the chronic analysis indicate that the estimated chronic dietary risk associated with the existing and EPA-recommended uses of pyriproxyfen is below EPA's level of concern.
Table 3.--Summary of Results from Chronic DEEM\TM\ Analysis of Pyriproxyfen
Exposure Subgroup
(mg/kg/day) % cPAD
U.S. Population (total)
0.003836
1.1
All Infants (6F04737, DP Barcode D228556, J. Garbus, 5/6/97) for pyriproxyfen. Pyriproxyfen was recovered from fortified apple and cotton samples through protocols A, C, D, E, and F. The results have been forwarded to FDA.-
Adequate enforcement methodology (example--gas chromotography) is available to enforce the tolerance expression. The method may be requested from: Francis Griffith, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address: griffith.francis@epa.gov.
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International Residue Limits
There are no Codex, Canadian, or Mexican maximum residue limits (MRLs) for residues of pyriproxyfen in/on any of the crops involved in the proposed new uses. Therefore, international harmonization is not an issue at this time.
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Conclusion-
Therefore, the tolerances are established for residues of pyriproxyfen, [2-[1-methyl-2-(4-phenoxyphenoxy)ethoxy]pyridine], in or on Brassica, head and stem, subgroup 5A; Brassica, leafy greens, subgroup 5B; vegetable, cucurbit, group 9; olive and olive, oil at 0.70, 2.0, 0.10, 1.0, and 2.0 ppm.respectively.
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Objections and Hearing Requests -
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. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) of the FFDCA provides essentially the same process for persons to ``object'' to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408(d) of FFDCA, as was provided in the old sections 408 and 409 of the FFDCA. However, the period for filing objections is now 60 days, rather than 30 days.
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What Do I Need to Do to File an Objection or Request a Hearing?-
You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP-2002-0345 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 May 6, 2003.-
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Filing the request. Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections (40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues(s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector (40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice.-
Mail your written request to: Office of the Hearing Clerk (1900C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. You may also deliver your request to the Office of the Hearing Clerk in Rm.104, Crystal Mall 2, 1921 Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (703) 603-0061.-
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Tolerance fee payment. If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or request a waiver of that fee pursuant to 40 CFR 180.33(m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it ``Tolerance Petition Fees.'' -
EPA is authorized to waive any fee requirement ``when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.'' For additional information regarding the waiver of these fees, you may contact James Tompkins by telephone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov, or by mailing a request for information to: Mr.
Tompkins, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. -
If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. -
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Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VI.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.1. Mail your copies, identified by docket ID number OPP-2002-0345, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460- 0001. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.1. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov. Please use an ASCII
file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.
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When Will the Agency Grant a Request for a Hearing?-
A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account
[[Page 10982]]
uncontested claims or facts to the contrary; and resolution of the factual issues(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32).--
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Statutory and Executive Order Reviews--
This final rule establishes a tolerance under section 408(d) of the 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 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 petition under section 408(d) of the 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. 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.
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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: February 24, 2003. Debra Edwards, Acting Director, Registration Division, Office of Pesticide Programs.-
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]-
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The authority citation for part 180 continues to read as follows:-
Authority: 21 U.S.C. 321(q), 346(a) and 371.
-2. Section 180.510 is amended by alphabetically adding commodities to the table in paragraph (a)(1) to read as follows:
Sec. 180.510 Pyriproxyfen; tolerances for residues.
(a) * * *
(1) * * *
Parts per Commodity
million
* * * * * Brassica, head and stem, subgroup 5A.......................
0.70 Brassica, leafy greens, subgroup 5B........................
2.0 * * * * * Olive......................................................
1.0 Olive, oil.................................................
2.0 * * * * * Vegetable, cucurbit, group 9...............................
0.10 * * * * *
* * * * *
[FR Doc. 03-5478 Filed 3-6-03; 8:45 am]
BILLING CODE 6560-50-S
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