02-24232. Clopyralid; Pesticide Tolerance

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule.

SUMMARY:

This regulation establishes tolerances for residues of clopyralid in or on certain raw agricultural commodities. Interregional Research Project Number 4 (IR-4) and Dow Agro Sciences LLC requested these tolerances under the Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality Protection Act of 1996.

DATES:

This regulation is effective September 25, 2002. Objections and requests for hearings, identified by docket control number OPP-2002-0235, must be received on or before November 25, 2002.

ADDRESSES:

Written objections and hearing requests may be submitted by mail, in person, or by courier. Please follow the detailed instructions for each method as provided in Unit VI. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, your objections and hearing requests must identify docket control number OPP-2002-0235 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:

By mail: Joanne I. Miller, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460; telephone number: 703 305-6224; and e-mail address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

Categories	NAICS codes	Examples of potentially affected entities
Industry	111 112 311 32532	Crop production Animal production Food manufacturing Pesticide manufacturing

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 the table could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents?

1. Electronically.You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/​. To access this document, on the Home Page select “Laws and Regulations,” “Regulations and Proposed Rules,” and then look up the entry for this document under the “Federal Register—Environmental Documents.” You can also go directly to the Federal Register 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 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.

2. In person. The Agency has established an official record for this action under docket control number OPP-2002-0235. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is ailable for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is [phone].

II. Background and Statutory Findings

In the Federal Register of August 14, 2002 (67 FR 52990) (FRL-7191-7), EPA issued a notice pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170), announcing the filing of pesticide petitions (PP 1E6227, 1E6241, 1E6283, 1E6291, 1E6320, 1E6329, 1E6333, 1E6334, 1E6335, 1E6399, and 1E6340 ) by the Interregional Research Project Number 4 (IR-4), P.O. Box 231, Rutgers University, New Brunswick, NJ 08903 and PP 4F4379 from Dow Agro Sciences LLC, Indianapolis, IN 46268. This notice included a summary of the petition prepared by Dow Agro Sciences LLC, the registrant. There were no comments received in response to the notice of filing.

The petitions requested that 40 CFR 180.431 be amended by establishing tolerances for residues of the herbicide clopyralid, 3,6-dichloro-2-pyridinecarboxylic acid, in or on the following commodities: Flax seed at 3.0 part per million (ppm); strawberry at 1.0 ppm; hop, dried cones at 5.0 ppm; rapeseed seed, rapeseed forage, canola seed, mustard seed, and crambe seed at 3 ppm, and canola meat at 6.0 ppm; spinach at 5.0 ppm; stone fruit group at 0.5 ppm; garden beet tops at 3.0 ppm and garden beet roots at 4.0 ppm; mustard greens at 5.0 ppm; turnip roots at 1.0 ppm and turnip greens at 4.0 ppm; cranberry at 4 ppm; sweet corn, kernel plus cob with husks removed at 1.0 ppm, sweet corn forage at 7.0 ppm, sweet corn stover at 10.0 ppm, pop corn grain at 1.0 ppm, pop corn stover at 10.0 ppm, liver of cattle, goat, horse, and sheep at 3.0 ppm, meat byproducts, except liver, of cattle, goat, horse and sheep at 36.0 ppm, and milk at 0.2 ppm; and the brassica, head and stem, subgroup at 2.0 ppm. EPA is editorially correcting the tolerance expressions to read canola meal and turnip, tops.

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) 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) 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 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).

III. Aggregate Risk Assessment and Determination of Safety

Consistent with 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, consistent with section 408(b)(2), for a tolerance for residues of clopyralid on strawberry at 1.0 ppm; hop, dried cones, at 5.0 ppm; rapeseed seed, rapeseed forage, mustard seed, and crambe seed at 3 ppm, canola meal and flax meal at 6.0 ppm; spinach at 5.0 ppm; stone fruit group at 0.5 ppm; prunes at 1.5 ppm, garden beet tops at 3.0 ppm and garden beet roots at 4.0 ppm; mustard greens at 5.0 ppm; turnip roots at 1.0 ppm and turnip tops at 4.0 ppm; cranberry at 4.0 ppm; sweet corn, kernel plus cob with husks removed at 1.0 ppm, sweet corn forage at 7.0 ppm, sweet corn stover at 10.0 ppm, pop corn grain at 1.0 ppm, pop corn stover at 10.0 ppm, liver of cattle, goat, horse, and sheep at 3.0 ppm, meat byproducts, except liver, of cattle, goat, horse and sheep at 36.0 ppm, and milk at 0.2 ppm; and the Brassica, head and stem, subgroup at 2.0 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. The nature of the toxic effects caused by clopyralid are discussed in the following Table 1 and Table 2 as well as the no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL) from the toxicity studies reviewed.

Table 1.—Subchronic, Chronic, and Other Toxicity of Clopyralid

Guideline No.	Study Type	Results
870.3100	90-Day oral toxicity in mice	NOAEL = 2,000 mg/kg/day in both sexes. LOAEL = 5,000 mg/kg/day in both sexes based on decreased body weight in both sexes.
870.3200	21/28-Day dermal toxicity in rabbits	NOAEL = 1,000 mg/kg/day for both sexes.
870.3700	Prenatal developmental toxicity in rats	Maternal NOAEL = 75 mg/kg/day LOAEL = 250 mg/kg/day based on mortality, reduced body weight gains and reduced food consumption. Developmental NOAEL = 250 mg/kg/day highest dose tested (HDT).
870.3700	Prenatal developmental toxicity in rabbits	Maternal NOAEL = 110 mg/kg/day. LOAEL = 250 mg /kg/day based on mortality, clinical signs, decreased body weight gains, and lesions of the gastric mucosa. Developmental NOAEL = 110 mg/kg/day. LOAEL = 250 mg/kg/day based on decreased fetal body weight and hydrocephalus.
870.3800	Reproduction and fertility effects in rats	Systemic NOAEL = 500 mg/kg/day for males and females LOAEL = 1,500 mg/kg/day for males and females based on decreased body weights, decreased weight gain, and decreased food consumption in both sexes and slight focal hyperkeratotic changes in gastric squamous mucosa in males. Reproductive/Offspring NOAEL = 500 mg/kg/day LOAEL = 1,500 mg/kg/day for males and females based on reduced pup weights in males and increased relative liver weight in pups of both sexes.
870.4100	Chronic toxicity dogs	NOAEL = 100 mg/kg/day in males and females. LOAEL = 320 mg/kg/day based upon reduction in hematological parameters in both sexes, increased absolute liver weight in males, and vacuolated adrenal cortical cells in females.
870.4200	Carcinogenicity mice	NOAEL = 500 mg/kg/day and ≥2,000 mg/kg/day in females. LOAEL = 2,000 mg/kg/day in males based on decreased body weight, body weight gains, and food efficiency. No evidence of carcinogenicity.
870.4300	Combined Chronic Toxicity/ Carcinogenicity in rats	NOAEL = 15 mg/kg/day. LOAEL = 150 mg/kg/day based on epithelial hyperplasia and thickening of the limiting ridge of the stomach in both sexes. No evidence of carcinogenicity.
870.5300	In vitro and in vivo host mediated assay in bacteria	No evidence of induced mutant colonies over background in Salmonella strains TA 1,530 bacteria and G-46 and Saccharomyces strain D-3
870.5385	Bone marrow chromosome aberrations assay	There was no significant increase in the frequency of chromosome aberrations in bone marrow at any dose tested.
870.5550	In vitro unscheduled DNA synthesis assay	There was no evidence of unscheduled DNA synthesis in initial or supplementary assays.
870.5450	Dominant lethal assay in rats.	No evidence of treatment related resorptions up to 400 mg/kg/day for 5 days.
870.7485	Metabolism in rats	Rapidly absorbed and excreted mainly in the urine. Parent compound only is detected in the excreta.

B. Toxicological Endpoints

The dose at which 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 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 factor 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 Safety Factor.

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.

The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases (e.g., risk is expressed as 1 x 10^-6 or one in a million). Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non-linear approach, a “point of departure” is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure (MOE_cancer = point of departure/exposures) is calculated. A summary of the toxicological endpoints for clopyralid used for human risk assessment is shown in the following Table 2:

Table 2.—Summary of Toxicological Dose and Endpoints for Clopyralid for Use in Human Risk Assessment

Exposure Scenario	Dose Used in Risk Assessment, UF	FQPA SF* and Level of Concern for Risk Assessment	Study and Toxicological Effects
Acute Dietary (General population, including infants and children)	NOAEL = 75 mg/kg/day UF = 100 Acute RfD = 0.75 mg/kg/day	FQPA SF = 1X aPAD = acute RfD/FQPA SF = 0.75 mg/kg/day	Developmental Toxicity Study - rat Maternal LOAEL = 250 mg ai/ kg/day based on decreased weight gain during gestation days 6-9
Chronic Dietary (All populations)	NOAEL = 15 mg/kg/day UF = 100 Chronic RfD = 0.15 mg/kg/day	FQPA SF = 1X cPAD = chronic RfD/FQPA SF = 0.15 mg/kg/day	2-Year Chronic Toxicity/Carcinogenicity Study - rat LOAEL = 150 mg ai/kg/day based on increased epithelial hyperplasia and thickening of the limiting ridge of the stomach in both sexes
Short-Term Incidental Oral	NOAEL = 75 mg/kg/day	LOC for MOE = 100	Developmental Toxicity Study - rat Maternal LOAEL = 250 mg ai/ kg/day based on decreased weight gain during gestation days 6-9
Intermediate Term Incidental Oral	NOAEL = 15 mg/kg/day	LOC for MOE = 100	2-Year Chronic Toxicity/Carcinogenicity Study - rat LOAEL = 150 mg ai/kg/day based on increased epithelial hyperplasia and thickening of the limiting ridge of the stomach in both sexes
Short-Term (1-7 days) and Intermediate-Term (1 week - several months) Dermal	None	No systemic toxicity was seen at the limit dose (1,000 mg/kg/day) in the 21-day dermal toxicity study in rabbits. This risk assessment is not required.	Not Applicable (N/A)
Short-Term (1-7 days) Inhalation	NOAEL = 75 mg/kg/day (inhalation absorption rate = 100%)	LOC for MOE = 100	Developmental Toxicity Study - rat Maternal LOAEL = 250 mg ai/kg/day based on decreased body weight gain
Cancer (Oral, dermal, inhalation)	Not likely	N/A	Acceptable oral rat and mouse carcinogenicity studies; no evidence of carcinogenic or mutagenic potential.
* The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique to the FQPA.

C. Exposure Assessment

1. Dietary exposure from food and feed uses. Tolerances have been established (40 CFR 180.431) for the residues of clopyralid, in or on a variety of raw agricultural commodities. Established, proposed and increased tolerances for clopyralid are adequate for any expected secondary residues in meat, milk, poultry and/or eggs. Risk assessments were conducted by EPA to assess dietary exposures from clopyralid 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 one day or single exposure. In conducting this acute dietary risk assessment the Dietary Exposure Evaluation Model (DEEM^TM) analysis evaluated the individual food consumption as reported by respondents in the USDA 1989-1992 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 acute exposure assessments. Residue levels are at the recommended tolerances with the exception of sugar beets. The empirical processing factor of 0.1x was used for sugar-beet representing the 10-fold reduction in residues for refined sugar. One hundred percent of all of the crops are treated with clopyralid.

ii. Chronic exposure. In conducting this chronic dietary risk assessment the Dietary Exposure Evaluation Model (DEEM^TM) analysis evaluated the individual food consumption as reported by respondents in the USDA 1989-1992 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. Residue levels are at the recommended tolerances with the exception of sugar beets. The empirical processing factor of 0.1x was used for sugar-beet representing the 10-fold reduction in residues for refined sugar. One hundred percent of all of the crops are treated with clopyralid.

iii. Cancer. Acceptable oral rat and mouse carcinogenicity studies show no evidence of carcinogenic or mutagenic potential. Clopyralid is classified as not likely to be a human carcinogen.

2. Dietary exposure from drinking water. The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for clopyralid 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 clopyralid.

The Agency uses the Generic Estimated Environmental Concentration (GENEEC) or the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) to estimate pesticide concentrations in surface water and SCI-GROW, which predicts pesticide concentrations in groundwater. In general, EPA will use GENEEC (a tier 1 model) before using PRZM/EXAMS (a tier 2 model) for a screening-level assessment for surface water. The GENEEC model is a subset of the PRZM/EXAMS model that uses a specific high-end runoff scenario for pesticides. GENEEC incorporates a farm pond scenario, while PRZM/EXAMS incorporate an index reservoir environment in place of the previous pond scenario. The PRZM/EXAMS model includes a percent crop area factor as an adjustment to account for the maximum percent crop coverage within a watershed or drainage basin.

None of these models include consideration of the impact processing (mixing, dilution, or treatment) of raw water for distribution as drinking water would likely have on the removal of pesticides from the source water. The primary use of these models by the Agency at this stage is to provide a coarse screen for sorting out pesticides for which it is highly unlikely that drinking water concentrations would ever exceed human health levels of concern.

Since the models used are considered to be screening tools in the risk assessment process, the Agency does not use estimated environmental concentrations (EECs) from these models to quantify drinking water exposure and risk as a %RfD or %PAD. Instead drinking water levels of comparison (DWLOCs) are calculated and used as a point of comparison against the model estimates of a pesticide's concentration in water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food, and from residential uses. Since DWLOCs address total aggregate exposure to clopyralid they are further discussed in the aggregate risk sections in Unit III.E of this document.

Based on the FIRST and SCI-GROW models the estimated environmental concentrations (EECs) of clopyralid for acute exposures are estimated to be 46 parts per billion (ppb) for surface water and 9.7 ppb for ground water. The EECs for chronic exposures are estimated to be 18 ppb in surface water and 9.7 ppb 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).

Clopyralid is currently registered for use on the following residential non-dietary sites: Turf and ornamentals (including golf courses). The risk assessment was conducted using the following residential exposure assumptions: the 75 mg/kg/day NOAEL was used in the short-term inhalation, hand-to-mouth, and episodic granular ingestion risk assessments of the residential exposure. The intermediate-term assessment for children's hand-to-mouth exposure was based on the 15 mg/kg/day NOAEL chosen for incidental oral exposure. As no dermal endpoint was selected, a dermal risk assessment was not required for residential exposure. For residential oral and inhalation risk assessments, the target margin of exposure (MOE) was 100 which incorporates the removal of the FQPA Safety Factor. MOEs calculated for residential handler's inhalation exposure and children's oral exposures were well above the target of 100; and therefore, do not exceed the Agency's level of concern.

4. Cumulative exposure to substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) 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.”

EPA does not have, at this time, available data to determine whether clopyralid has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, clopyralid 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 clopyralid 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 final rule for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

D. Safety Factor for Infants and Children

1. In general. FFDCA section 408 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 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. No increased quantitative or qualitative susceptibility was seen following pre- and/or post-natal exposures. In the developmental study with rats, no developmental toxicity was seen at the HDT (250 mg/kg/day) even in the presence of severe maternal toxicity which manifested as deaths, reduced body weight gain and decreased food consumption. In the two generation reproduction study, offspring toxicity, characterized as decreased pup weight and increased liver weights, occurred only at the HDT (1,500 mg/kg/day) which is higher than the Limit Dose (1,000 mg/kg/day). These changes occurred in the presence of severe parental toxicity (decreased body weight, body weight gain, food consumption and slight focal hyper keratosis of the gastric mucosa). In the developmental rabbit study, hydrocephalus was seen in eight fetuses (3/15 litters) only at the highest dose tested (250 mg/kg/day) in the presence of severe maternal toxicity that manifested as death, decreases in mean body weight and lesions of the gastric mucosa; the developmental NOAEL was 110 mg/kg/day. The available data indicate that a developmental neurotoxicity study would have to be tested at dose levels higher than 250 mg/kg/day because no developmental toxicity was observed in rats at 250 mg/kg/day. In addition, the offspring NOAEL in the two generation reproduction study was 500 mg/kg/day with a LOAEL of 1,500 mg/kg/day. Therefore, it is anticipated that in order to elicit any fetal nervous system abnormalities in a developmental neurotoxicity study, the selected dose levels would have to be higher than 500 mg/kg/day. Since the dose level selections for the developmental neurotoxicity study will be greater than 500 mg/kg/day, the resultant NOAEL will be either comparable to, or higher than the doses currently used in the risk assessment. The NOAEL of 75 mg/kg/day selected for the acute RfD is seven times lower than the offspring NOAEL in the reproduction study. The NOAEL of 15 mg/kg/day selected for the chronic RfD and the residential exposure risk assessments is thirty three times lower than the offspring NOAEL in the reproduction study. Therefore, a developmental neurotoxicity study would not likely change the regulatory doses used for overall risk assessments.

3. Conclusion. EPA determined that an additional factor to protect infants and children was not appropriate. Several factors influenced this decision not to require a development neurotoxicity (DNT) study:

i. Although hydrocephalus was observed at the high dose in the developmental rabbit study, it was seen in the presence of severe maternal toxicity;

ii. No alterations to the fetal nervous system were seen in the developmental rat study at the same dose (250 mg/kg/day);

iii. There was no quantitative or qualitative evidence of increased susceptibility in the two generation reproduction study;

iv. There is no concern nor are there residual uncertainties for pre and/or post natal toxicity; and

v. Although there are no acute or subchronic neurotoxicity studies, there is no evidence of neurotoxicity or neuropathology in adult animals in any of the studies. EPA decided that the FQPA safety factor should be reduced to 1 rather than the statutory default factor of 10 because the existing toxicology database, which is complete, revealed no quantitative or qualitative evidence of increased susceptibility following in utero exposure to rats and rabbits and/or following prenatal/postnatal exposure to rats; and dietary (food and drinking water) and residential exposure assessments will not underestimate the potential exposures for infants, children, and/or women of childbearing age from the use of clopyralid.

E. Aggregate Risks and Determination of Safety

To estimate total aggregate exposure to a pesticide from food, drinking water, and residential uses, the Agency calculates DWLOCs which are used as a point of comparison against the model estimates of a pesticide's concentration in water (EECs). DWLOC values are not regulatory standards for drinking water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food and residential uses. In calculating a DWLOC, the Agency determines how much of the acceptable exposure (i.e., the PAD) is available for exposure through drinking water [e.g., allowable chronic water exposure (mg/kg/day) = cPAD - (average food + residential exposure)]. This allowable exposure through drinking water is used to calculate a DWLOC.

A DWLOC will vary depending on the toxic endpoint, drinking water consumption, and body weights. Default body weights and consumption values as used by the USEPA Office of Water are used to calculate DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg (child). Default body weights and drinking water consumption values vary on an individual basis. This variation will be taken into account in more refined screening-level and quantitative drinking water exposure assessments. Different populations will have different DWLOCs. Generally, a DWLOC is calculated for each type of risk assessment used: Acute, short-term, intermediate-term, chronic, and cancer.

When EECs for surface water and ground water are less than the calculated DWLOCs, OPP concludes with reasonable certainty that exposures to the pesticide in drinking water (when considered along with other sources of exposure for which OPP has reliable data) would not result in unacceptable levels of aggregate human health risk at this time. Because OPP considers the aggregate risk resulting from multiple exposure pathways associated with a pesticide's uses, levels of comparison in drinking water may vary as those uses change. If new uses are added in the future, OPP will reassess the potential impacts of residues of the pesticide in drinking water as a part of the aggregate risk assessment process.

1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food to clopyralid will occupy 4% of the aPAD for the U.S. population, 2% of the aPAD for females 13 years and older, 4% of the aPAD for all infants (< 1 year) and 7% of the aPAD for children 1-6 years. In addition, there is potential for acute dietary exposure to clopyralid in drinking water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the aPAD, as shown in the following Table 3:

Table 3.—Aggregate Risk Assessment for Acute Exposure to Clopyralid

Population Subgroup	aPAD (mg/kg)	% aPAD (Food)	Surface Water EEC (ppb)	Ground Water EEC (ppb)	Acute DWLOC (ppb)
General U.S. Population	0.75	4	46	9.7	25,000
All Infants (< 1 year)	0.75	4	46	9.7	7,200
Children 1-6 years	0.75	7	46	9.7	7,000
Females 13-50	0.75	2	46	9.7	22,000

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to clopyralid from food will utilize 7% of the cPAD for the U.S. population, 7% of the cPAD for all infants (< 1 year) and 17% of the cPAD for children 1-6 years. Based on the use pattern, chronic residential exposure to residues of clopyralid is not expected. In addition, there is potential for chronic dietary exposure to clopyralid in drinking water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in the following Table 4:

Table 4.—Aggregate Risk Assessment for Chronic (Non- Cancer) Exposure to Clopyralid

Population Subgroup	cPAD mg/kg/day	% cPAD (Food)	Surface Water EEC (ppb)	Ground Water EEC (ppb)	Chronic DWLOC (ppb)
U.S. Population	0.15	7	18	9.7	4,900
All Infants (< 1 year)	0.15	7	18	9.7	1,400
Children 1-6 years	0.15	17	18	9.7	1,200
Females 13-50	0.15	5	18	9.7	4,300

3. Short-term risk. Short-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

Clopyralid is currently registered for use that could result in short-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic food and water and short-term exposures for clopyralid.

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded that food and residential exposures aggregated result in aggregate MOEs of 7,000 (U.S. population, food and residential), 9,600 (females 13-50, food and residential) and 2,200 (children 1-6 years old, food and residential). These aggregate MOEs do not exceed the Agency's level of concern for aggregate exposure to food and residential uses. In addition, short-term DWLOCs were calculated and compared to the EECs for chronic exposure of clopyralid in ground and surface water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect short-term aggregate exposure to exceed the Agency's level of concern, as shown in the following Table 5:

Table 5.—Aggregate Risk Assessment for Short-Term Exposure to Clopyralid

Population Subgroup	Aggregate MOE (Food + Residential)	Aggregate Level of Concern (LOC)	Surface Water EEC (ppb)	Ground Water EEC (ppb)	Short-Term DWLOC (ppb)
U.S. Population	7,000	100	18	9.7	26,000
Children 1-6 years	2,200	100	18	9.7	7,200
Females 13-50 years	9,600	100	18	9.7	22,000

4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

Clopyralid is currently registered for use(s) that could result in intermediate-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic food and water and intermediate-term exposures for clopyralid.

Using the exposure assumptions described in this unit for intermediate-term exposures, EPA has concluded that food and residential exposures aggregated result in an aggregate MOE of 530 (children 1-6 years, food and residential). This aggregate MOE does not exceed the Agency's level of concern for aggregate exposure to food and residential uses. In addition, an intermediate-term DWLOC was calculated and compared to the EECs for chronic exposure of clopyralid in ground and surface water. After calculating the DWLOC and comparing it to the EECs for surface and ground water, EPA does not expect intermediate-term aggregate exposure to exceed the Agency's level of concern, as shown in the following Table 6:

Table 6.—Aggregate Risk Assessment for Intermediate-Term Exposure to Clopyralid

Population Subgroup	Aggregate MOE (Food + Residential)	Aggregate Level of Concern (LOC)	Surface Water EEC (ppb)	Ground Water + EEC (ppb)	Intermediate-Term DWLOC (ppb)
Children 1-6 years	530	100	18	9.7	1,200

5. Aggregate cancer risk for U.S. population. The Agency concluded that clopyralid was negative for carcinogenicity potential in rats and mice and classified clopyralid as “not likely” to be a human carcinogen according to EPA Draft Guidelines for Carcinogen Risk Assessment.

6. 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 clopyralid residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

An adequate residue analytical method is available for enforcement of the proposed tolerances. This method, ACR 75.6, determines clopyralid as the methyl ester by gas chromatography using electron capture detection. This method has been successfully validated by EPA and has been published in FDA's Pesticide Analytical Manual, Vol-II (PAM II).

An adequate residue analytical method is also available for the enforcement of the proposed tolerance on animal commodities. This method, ACR 86.1, determines clopyralid as the methyl ester by gas chromatography using electron capture detection. This method has been successfully validated by EPA and has been published in FDA's Pesticide Analytical Manual, Vol-II (PAM II).

B. International Residue Limits

There are no Codex or Mexican maximum residue limits (MRLs). Canada has set maximum residue limits of 2.0 ppm for barley, oats, and wheat, 7.0 ppm for the milled fractions of barley, oats, and wheat (excluding flour), 1.0 ppm for strawberries and 0.2 ppm for flax.

V. Conclusion

Therefore, tolerances are established for residues of clopyralid on strawberry at 1.0 ppm; hop, dried cones, at 5.0 ppm; rapeseed seed, rapeseed forage, mustard seed, and crambe seed at 3.0 ppm, canola meal and flax meal at 6.0 ppm; spinach at 5.0 ppm; stone fruit group at 0.5 ppm; prunes at 1.5 ppm, garden beet tops at 3.0 ppm and garden beet roots at 4.0 ppm; mustard greens at 5.0 ppm; turnip roots at 1.0 ppm and turnip tops at 4.0 ppm; cranberry at 4.0 ppm; sweet corn, kernel plus cob with husks removed at 1.0 ppm, sweet corn forage at 7.0 ppm, sweet corn stover at 10.0 ppm, pop corn grain at 1.0 ppm, pop corn stover at 10.0 ppm, liver of cattle, goat, horse, and sheep at 3.0 ppm, meat byproducts, except liver, of cattle, goat, horse and sheep at 36.0 ppm, and milk at 0.2 ppm; and the brassica, head and stem, subgroup at 2.0 ppm.

VI. 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 of 1996, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) 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), as was provided in the old FFDCA sections 408 and 409. However, the period for filing objections is now 60 days, rather than 30 days.

A. 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 control number OPP-2002-0235 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 November 25, 2002.

1. 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. 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 [phone].

2. 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 phone at [phone], by e-mail at [e-mail], or by mailing a request for information to Mr. Tompkins at Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

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.

3. 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.2. Mail your copies, identified by docket control number OPP-2002-0235, 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. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.2. You may also send an electronic copy of your request via e-mail to: [e-mail]. 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.

B. 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 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).

VII. Regulatory Assessment Requirements

This final rule establishes a tolerance under FFDCA section 408(d) 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 FFDCA section 408(d), 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 FFDCA section 408(n)(4). For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

VIII. Submission to Congress and the Comptroller General

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: September 16, 2002.

Peter Caulkins,

Acting Director, Registration Division, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is amended as follows:

PART 180—[AMENDED]

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

Authority: 21 U.S.C. 321(q), 346(a) and 374.

2. Section 180.431 is amended as follows:

i. By alphabetically adding commodities to the table in paragraph (a);

ii. By removing tolerances for cattle, kidney; goat, kidney; horse, kidney and sheep, kidney in the table in paragraph (a);

iii. By increasing tolerances for cattle, meat byproducts, except liver; goat, meat byproducts, except liver; horse, meat byproducts, except liver and sheep, meat byproducts, except liver; and milk in the table in paragraph (a); and

iv. By removing the text from paragraph (b); and reserving paragraph (b) with the heading.

The additions and revisions read as follows:

§ 180.431

Clopyralid; tolerances for residues.

(a) General. Tolerances are established for residues of the herbicide clopyralid (3,6-dichloro-2-pyridinecarboxylic acid) in or on the following commodities:

Commodity	Parts per million
*  *  *  *  *
Beet, garden, tops	3.0
Beet, garden, roots	4.0
Brassica, head and stem, subgroup	2.0
Canola, meal	6.0
Canola, seed	3.0
*  *  *  *  *
Cattle, liver	3.0
*  *  *  *  *
Cattle, meat byproducts, except liver	36.0
*  *  *  *  *
Corn, pop, grain	1.0
Corn, pop, stover	10.0
Corn, sweet, forage	7.0
Corn, sweet, kernel plus cob with husks removed	1.0
Corn, sweet, stover	10.0
Crambe, seed	3.0
Cranberry	4.0
*  *  *  *  *
Flax, meal	6.0
Flax, seed	3.0
Fruit, stone, group	0.5
*  *  *  *  *
Goat, liver	3.0
*  *  *  *  *
Goat, meat byproducts, except liver	36.0
*  *  *  *  *
Hop, dried cones	5.0
*  *  *  *  *
Horse, liver	3.0
*  *  *  *  *
Horse, meat byproducts, except liver	36.0
Milk	0.2
*  *  *  *  *
Mustard, greens	5.0
Mustard, seed	3.0
*  *  *  *  *
Plum, prune, dried	1.5
*  *  *  *  *
Rapeseed, seed	3.0
Rapeseed, forage	3.0
*  *  *  *  *
Sheep, liver	3.0
*  *  *  *  *
Sheep, meat byproducts, except liver	36.0
*  *  *  *  *
Spinach	5.0
Strawberry	1.0
*  *  *  *  *
Turnip, roots	1.0
Turnip, tops	4.0
*  *  *  *  *

(b) Section 18 emergency exemptions. [Reserved]

* * * * *