Environmental Protection Agency (EPA).
Final rule.
This regulation establishes tolerances for combined residues of pendimethalin in or on artichoke, globe; asparagus; brassica head and stem, subgroup 5-A; and grape. Interregional Research Project Number 4 requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
This regulation is effective September 19, 2007. Objections and requests for hearings must be received on or before November 19, 2007, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the
EPA has established a docket for this action under docket identification (ID) number EPA–HQ–OPP–2007–0106. To access the electronic docket, go to
Susan Stanton, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (703) 305–5218; e-mail address:
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
In addition to accessing an electronic copy of this
Under section 408(g) of 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–2007–0106 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 November 19, 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
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In the
Based upon review of the data supporting the petition, EPA has revised the tolerances for artichoke, globe; asparagus; brassica, head and stem vegetables, subgroup 5-A; and grape. The reason for these changes is explained in Unit V.
Section 408(b)(2)(A)(i) of 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 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 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....” These provisions were added to FFDCA by the Food Quality Protection Act (FQPA) of 1996.
Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA 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 tolerance for combined residues of pendimethalin and its metabolite on artichoke, globe at 0.1 ppm; asparagus at 0.15 ppm; brassica head and stem, subgroup 5-A at 0.1; and grape at 0.1 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows.
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 pendimethalin, 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
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 (UFs) 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 UFs. 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 UFs 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
A summary of the toxicological endpoints for pendimethalin used for human risk assessment can be found at
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Based on the Pesticide Root Zone Model /Exposure Analysis Modeling System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-GROW) models, the estimated environmental concentrations (EECs) of pendimethalin for acute exposures are estimated to be 77.7 parts per billion (ppb) for surface water and 0.036 ppb for ground water. The EECs for chronic exposures are estimated to be 6.0 ppb for surface water and 0.036 ppb for ground water.
Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. As explained in Unit III.C.1., an acute dietary risk assessment was not conducted for pendimethalin. For the chronic dietary risk assessment, the water concentration of value 6.0 ppb was used to access the contribution to drinking water.
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Pendimethalin is currently registered for the following residential non-dietary sites: Recreational and residential turf (including home lawns, golf courses, athletic fields, etc.) and ornamentals. EPA assessed residential exposure based on applications to residential turf (i.e., home lawns), since this use is expected to result in the greatest residential exposure.
There is a potential for short-term exposure of homeowners applying products containing pendimethalin on home lawns. There is also a potential for short-term post-application exposure of adults and children entering lawn and recreation areas previously treated with pendimethalin. Exposures from treated recreational sites are expected to be similar to, or lower than, those from treated residential turf sites; therefore, a separate exposure assessment for recreational turf sites was not conducted. EPA assessed exposures from the following residential turf post-application scenarios:
• Adult and toddler post-application dermal exposure from contact with treated lawns.
• Toddlers’ incidental ingestion of pesticide residues on lawns from hand-to-mouth transfer.
• Toddlers’ object-to-mouth transfer from mouthing of pesticide-treated turfgrass.
• Toddlers’ incidental ingestion of soil from pesticide-treated residential areas.
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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 pendimethalin and any other substances and pendimethalin 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 pendimethalin 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
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In the rat developmental study, there were no maternal or developmental effects noted at any dose level tested. However, the study is considered adequate and a new study is not required because in other rat studies, thyroid toxicity was seen at significantly lower doses than the highest dose tested (500 milligrams/kilograms/day (mg/kg/day)) in this study. If thyroid parameters had been measured, maternal toxicity would likely have been demonstrated.
The rabbit toxicity study with pendimethalin did not demonstrate maternal or developmental toxicity at doses up to 60 mg/kg/day (highest dose tested). Since neither maternal nor developmental toxicity was seen at the highest dose tested, potential for increased sensitivity of the offspring could not be determined.
In the 2–generation reproduction study in rats, there was no evidence of increased susceptibility of offspring. Effects in the pups (decreased pup body weight gain and possible decreased pups born alive and pup survival) were seen at doses that also resulted in parental toxicity (decreased body weight).
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i. The toxicity database for pendimethalin contains all of the standard toxicity studies. However, there is uncertainty regarding potential thyroid effects seen in some of these
ii. There is no indication that pendimethalin is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.
iii. There is no evidence that pendimethalin results in increased susceptibility in
iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. Conservative ground and surface water modeling estimates were used. Similarly, conservative Residential SOPs were used to assess post-application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by pendimethalin.
Although the exposure estimate is very conservative and there are no neurotoxic concerns for pendimethalin, there is sufficient uncertainty regarding thyroid effects, particularly thyroid effects in the young, that EPA is retaining the 10X FQPA safety factor. EPA has also determined that the traditional 10X uncertainty factor to account for interspecies variation may be reduced to 3X, since it has been established that rats are more susceptible to thyroid effects than humans. These factors, together with the traditional 10X uncertainty factor to account for intraspecies variation, result in a total uncertainty factor of 300X (10X, 3X, and 10X).
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 UFs. For linear cancer risks, EPA calculates the probability of additional cancer cases given aggregate exposure. 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 UFs is not exceeded.
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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 of 650 for adult males, 580 for adult females, and 390 to 410 for children, 1 to 2 years old (depending on the application rate assessed). The aggregate MOEs for adults are based on the residential turf scenario and include combined food, drinking water and post-application dermal exposures. The aggregate MOEs for children include food, drinking water, post-application dermal and incidental oral exposures from entering turf areas previously treated with pendimethalin.
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Adequate enforcement methodology is available to enforce the tolerance expression. The PAM VII lists four gas chromatography, with electron capture detection (GC/ECD), methods for the determination of pendimethalin residues of concern in plant commodities. Methods I and III determine residues of the parent, whereas Methods II and IV determine residues of the regulated metabolite. An adequate confirmatory GC/MS method is also available and 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:
There are currently no Canadian, Mexican, or Codex maximum residue limits (MRLs) for pendimethalin on the commodities for which tolerances are being established.
Based upon review of the data supporting the petitions, EPA has modified the proposed tolerances as
The tolerances for artichoke, globe; brassica head and stem, subgroup 5-A; and grape were determined based on the sum of the method Limits of Quantitation (LOQ) for parent pendimethalin (0.05 ppm) and its regulated metabolite (0.05 ppm), since no detectable residues were found in the submitted residue field trials.
The tolerance for asparagus was determined using the Agency’s Tolerance Spreadsheet in accordance with the Agency’s
Therefore, tolerances are established for combined residues of pendimethalin,
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
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
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
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).
The Congressional Review Act, 5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
21 U.S.C. 321(q), 346a and 371.
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