Source: https://www.federalregister.gov/documents/2007/07/11/E7-13419/cymoxanil-pesticide-tolerance
Timestamp: 2018-04-23 16:07:34
Document Index: 209937890

Matched Legal Cases: ['art 178', 'art 178', 'art 178', 'art 178', 'art 2', '§\u2009180']

Federal Register :: Cymoxanil; Pesticide Tolerance
Cymoxanil; Pesticide Tolerance
A Rule by the Environmental Protection Agency on 07/11/2007
This regulation is effective July 11, 2007. Objections and requests for hearings must be received on or before September 10, 2007, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
72 FR 37641
37641-37646 (6 pages)
EPA-HQ-OPP-2006-0331
FRL-8130-5
E7-13419
https://www.federalregister.gov/d/E7-13419 https://www.federalregister.gov/d/E7-13419
This regulation establishes tolerances for residues of cymoxanil in or on grape, hop, and caneberry. The Interregional Research Project (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2006-0331. To access the electronic docket, go to http://www.regulations.gov, select “Advanced Search,” then “Docket Search.” Insert the docket ID number where indicated and select the “Submit” button. Follow the instructions on the regulations.gov web site to view the docket index or access available documents. All documents in the docket are listed in the docket index available in regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305-5805.
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 Start Printed Page 37642be 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.
Under section 408(g) of the FFDCA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2006-0331 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 September 10, 2007.
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit this copy, identified by docket ID number EPA-HQ-OPP-2006-0331, by one of the following methods:
Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305-5805.
In the Federal Register of May 10, 2006, (71 FR 27247) (FRL-8067-5), and November 15, 2006, (71 FR 66522) (FRL-8101-8) EPA issued notices pursuant to section 408(d)(3) of the FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of pesticide petitions PP 5E7000 (grape and hop), and PP 6E7100 (caneberry) by the IR-4, 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petitions requested that 40 CFR 180.503(a) be amended by establishing tolerances for residues of the fungicide cymoxanil, in or on grape (east of the Rocky Mountains) at 1.0 parts per million (ppm); hop, dried cones at 5.0 ppm; and caneberry at 4.0 ppm. These notices referenced a summary of the petitions prepared by Dupont, the registrant, which is available to the public in the docket, http://www.regulations.gov. Comments were received from a private citizen on the notice of filing for grape; and hop, dried cones. EPA's response to comment is discussed in Unit IV.C.
Consistent with section 408(b)(2)(D) of the FFDCA, and the factors specified in section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for the petitioned-for tolerance for residues of cymoxanil on grape at 0.10 ppm; hop, dried cone at 7.0 ppm; and caneberry at 4.0 ppm. EPA's assessment of exposures and risks associated with establishing these tolerances follow.
EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the adverse effects caused by cymoxanil as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov. The referenced document is available in the docket established by this action, which is described under ADDRESSES, and is identified as EPA-HQ-OPP-2006-0331 in that docket. Please refer to the Human Health Risk Assessment for Cymoxanil for New section 3 Uses in/on Grapes (East of the Rocky Mountains); Hop, dried cones; and Caneberry Subgroup 13A on pages 16-19.
For hazards that have a threshold below which there is no appreciable risk, the toxicological level of concern (LOC) is derived from the highest dose at which no adverse effects are observed (the NOAEL) in the toxicology study identified as appropriate for use in risk assessment. However, if a NOAEL cannot be determined, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment. Uncertainty/safety factors (UF) are used in conjunction with the LOC to take into account uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other Start Printed Page 37643unknowns. Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the acute population adjusted dose (“aPAD”) and chronic population adjusted dose (“cPAD”). The aPAD and cPAD are calculated by dividing the LOC by all applicable uncertainty/safety factors. Short-term, intermediate, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the margin of exposure (“MOE”) called for by the product of all applicable uncertainty/safety factors is not exceeded.
A summary of the toxicological endpoints for cymoxanil used for human risk assessment can be found at www.regulations.gov in the Human Health Risk Assessment for Cymoxanil for New section 3 Uses in/on Grapes (East of the Rocky Mountains); Hop, dried cone; and Caneberry Subgroup 13A, pages 19-20 in Docket ID EPA-HQ-OPP-2006-0331.
1. Dietary exposure from food and feed uses. In evaluating dietary exposure to cymoxanil, EPA considered exposure under the petitioned-for tolerances as well as all existing cymoxanil tolerances in (40 CFR 180.503(a)). EPA assessed dietary exposures from cymoxanil in food as follows:
i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. An acute dietary exposure assessment was performed for females 13-49 years old only, since an acute endpoint of concern was not identified for the general U.S. population. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 1994-1996, and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA assumed that cymoxanil residues were present in all registered and proposed food commodities at tolerance levels, and 100 percent crop treated (PCT) for all commodities. Dietary Exposure Evaluation Model (DEEM) version 7.81 default processing factors were used for all registered and proposed commodities except for grape juice and raisin.
ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994-1996 and 1998 Nationwide CSFII. As to residue levels in food, EPA used tolerance level residues for all commodities except lettuce, hops and grapes. Average residues from field trials were used for lettuce, hops and grapes. DEEM default processing factors were used for all commodities except grapes. Processing factors for grape juice (1.4x) and raisins (1x) were derived from grape processing data. Exposure estimates were further refined using screening-level PCT (% CT) data for several registered commodities. For all other commodities, including the proposed new uses, 100 %CT was assumed.
iii. Cancer. EPA has classified cymoxanil as a “not likely” human carcinogen. Therefore, a cancer dietary exposure analysis was not performed.
The Agency believes that the three conditions have been met. With respect to Condition 1, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions 2 and 3, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available information on the regional consumption of food to which cymoxanil may be applied in a particular area.Start Printed Page 37644
2. Dietary exposure from drinking water. The Agency lacks sufficient monitoring data to complete a comprehensive dietary exposure analysis and risk assessment for cymoxanil in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the environmental fate characteristics of cymoxanil. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/​oppefed1/​models/​water/​index.htm.
The Agency calculated screening level surface and ground water estimates for cymoxanil using FQPA Index Reservoir Screening Tool (FIRST (version 1.0)), and SCI-GROW (Screening Concentration In GROund Water) models, respectively. The proposed application rates for use on grape and hop are higher than the rates evaluated previously. Estimated drinking water concentrations were estimated based on the newly proposed application rate for grape (0.25 lbs per acre, 10 times), which was the highest application rate reported for the new proposed uses.
Based on the FIRST and SCI-GROW models, the estimated environmental concentrations (EECs) of cymoxanil for acute and chronic exposures are 0.019 parts per billion (ppb), and 0.0001 ppb, respectively for surface water. The EECs for groundwater (acute and chronic) are estimated to be 0.000003 ppb.
Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 0.019 ppb was used to access the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 0.0001 ppb was used to access the contribution to drinking 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). Cymoxanil is not registered for use on any sites that would result in residential exposure.
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 cymoxanil and any other substances and cymoxanil 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 cymoxanil has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at http://www.epa.gov/​pesticides/​cumulative.
2. Prenatal and postnatal sensitivity. There is an indication of increased susceptibility (qualitative and quantitative) of rats and rabbits to in utero exposure to cymoxanil. In the rat developmental toxicity study, decreased fetal body weights and skeletal malformations were observed at 25 mg/kg/day LOAEL, which is below the maternal toxicity of 75 mg/kg/day LOAEL. In the rabbit developmental study increased skeletal malformations were observed at 8 mg/kg/day LOAEL, also below the maternal NOAEL of 32 mg/kg/day. In the 2-generation reproduction study there was an indication of increased qualitative susceptibility in the offspring, since there was decreased pup viability at a dose that produced less severe effects in maternal animals.
3. Conclusion. EPA has determined that reliable data show that it would be safe for the infants and children FQPA safety factor to be reduced to 1X for acute dietary exposures. The EPA believes that this will be protective of infants and children based on the following findings:
i. The toxicity database for cymoxanil is complete for dietary risk assessment.
ii. Although there is qualitative evidence of increased susceptibility in the prenatal developmental studies in rats and rabbits, the risk assessment team did not identify any residual uncertainties after establishing toxicity endpoints and traditional uncertainty factors to be used in the risk assessment of cymoxanil. The degree of concern for pre-and/or postnatal toxicity is low.
iii. There are no residual uncertainties identified in the exposure databases. The acute dietary food exposure assessment was performed based on 100 PCT, tolerance-level residues, and DEEM default processing factors for all registered and proposed commodities. Conservative ground and surface water modeling estimates were also used and incorporated directly in the DEEM analysis. The Agency has determined with reasonably certainty that the identified assessment will not underestimate the exposure and risks posed by cymoxanil. However, the 10X FQPA safety factor was retained for chronic dietary exposure because a LOAEL was used to extrapolate a NOAEL for the chronic toxicity study in the dog.
Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the acute population adjusted dose (“aPAD”) and chronic population adjusted dose (“cPAD”). The aPAD and cPAD are calculated by dividing the LOC by all applicable uncertainty/safety factors. For linear cancer risks, EPA calculates the probability of additional cancer cases given aggregate exposure. Short-term, intermediate, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the margin of exposure (“MOE”) called for by the product of all applicable uncertainty/safety factors is not exceeded.
1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to cymoxanil will occupy 72% of the aPAD for the population group (females 13-49 years old).
2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded Start Printed Page 37645that exposure to cymoxanil from food and water will utilize 51% of the cPAD for children 1-2 years old, the subpopulation group with greatest exposure. There are no residential uses for cymoxanil that result in chronic residential exposure to cymoxanil.
3. Short and intermediate-term risks. Short and Intermediate-term aggregate exposures takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Cymoxanil is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's level of concern.
4. Aggregate cancer risk for U.S. population. EPA has classified cymoxanil as a “not likely” human carcinogen. Therefore, cymoxanil is not expected to pose a cancer risk.
5. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to cymoxanil residues.
Adequate enforcement methodologies (high performance liquid chromatography with ultra violet detection (HPLC/UV) and (HPLC/MS) using (mass spectroscopy) on grape, caneberry, and hop, respectively) are available to enforce the tolerance expression. The methods 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: residuemethods@epa.gov.
There are no for CODEX maximum residue levels established for cymoxanil on grape; hop, dried cone; and caneberry.
1. The availability of numerous products previously registered for the same purpose in which the new cymoxanil tolerances are intended, and
2. Cymoxanil is toxic to aquatic plants, bees, and birds, and therefore has potential harmful effects on the environment. These comments are considered irrelevant because the safety standard for approving tolerances under section 408 of the FFDCA focuses on potential harms to human health and does not permit consideration of effects on the environment or the availability of other registered products.
The proposed hop, dried cone tolerance was revised from 5.0 to 7.0 ppm based on submitted field trial residues. For grape, the proposed tolerance of 1.0 was lowered to 0.10 ppm. The residue field trials indicate 0.10 ppm as the appropriate regional tolerance for grape. Therefore, tolerances are established for residues of cymoxanil, 2-cyano-N-[(ethylamino)carbonyl]-2-(methoxyimino) acetamide in or on grape (east of the Rocky Mountains) at 0.10 ppm; hop, dried cone at 7.0 ppm; and caneberry at 4.0 ppm.
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, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of 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.
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 the FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000) do not apply to this rule. In addition, This rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).
End Amendment Part Start Part Start Printed Page 37646
2. Section 180.503 is amended by revising the table in paragraph (a); and by adding text to paragraph (c) to read as follows:
Caneberry 4.0
Lettuce, head 4.0
Lychee1 1.0
Vegetable, fruiting, group 8 0.2
1 There is no U.S. registration for lychee.
(c) Tolerances with a regional registration. Tolerances with a regional registration as defined in § 180.1(n) are established for the residues of the fungicide cymoxanil, 2-cyano -N- [(ethylamino)carbonyl]-2-(methoxyimino) acetamide) in or on the raw agricultural commodities:
Grape 0.10
[FR Doc. E7-13419 Filed 7-10-07; 8:45 am]