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Environmental Protection Agency (EPA).
Notice.Start Printed Page 35997
This notice announces the amendment of the pesticide petition (PP 6F3344) proposing the establishment of regulations for residues of a certain pesticide chemical in or on various food commodities.
Comments, identified by docket control number OPP-2002-0046, must be received on or before June 21, 2002.
Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I. C. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPP-2002-0046 in the subject line on the first page of your response.Start Further Info
FOR FURTHER INFORMATION CONTACT:
By mail: Treva Alston, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 308-8373; e-mail address: firstname.lastname@example.org.End Further Info End Preamble Start Supplemental 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|
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” “Regulation 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/.
2. In person. The Agency has established an official record for this action under docket control number OPP-2002-0046. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, 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 available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.
C. How and to Whom Do I Submit Comments?
You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPP-2002-0046 in the subject line on the first page of your response.
1. By mail. Submit your comments to: Public Information and Records Integrity Branch (PIRIB), Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
2. In person or by courier. Deliver your comments to: Public Information and Records Integrity Branch (PIRIB), Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.
3. Electronically. You may submit your comments electronically by e-mail to: email@example.com, or you can submit a computer disk as described above. Do not submit any information electronically that you consider to be CBI. Avoid the use of special characters and any form of encryption. Electronic submissions will be accepted in Wordperfect 6.1/8.0 or ASCII file format. All comments in electronic form must be identified by docket control number OPP-2002-0046. Electronic comments may also be filed online at many Federal Depository Libraries.
D. How Should I Handle CBI That I Want to Submit to the Agency?
Do not submit any information electronically that you consider to be CBI. You may claim information that you submit to EPA in response to this document as CBI 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. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public version of the official record. Information not marked confidential will be included in the public version of the official record without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person identified under FOR FURTHER INFORMATION CONTACT.
E. What Should I Consider as I Prepare My Comments for EPA?
You may find the following suggestions helpful for preparing your comments:
1. Explain your views as clearly as possible.
2. Describe any assumptions that you used.
3. Provide copies of any technical information and/or data you used that support your views.
4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide.Start Printed Page 35998
5. Provide specific examples to illustrate your concerns.
6. Make sure to submit your comments by the deadline in this notice.
7. To ensure proper receipt by EPA, be sure to identify the docket control number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation.
II. What Action is the Agency Taking?
EPA has received a pesticide petition as follows proposing the establishment and/or amendment of regulations for residues of a certain pesticide chemical in or on various food commodities under section 408 of the Federal Food, Drug, and Comestic Act (FFDCA), 21 U.S.C. 346a. EPA has determined that this petition contains data or information regarding the elements set forth in section 408(d)(2); however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petition. Additional data may be needed before EPA rules on the petition.Start List of Subjects
List of Subjects
- Environmental protection
- Agricultural commodities
- Feed additives
- Food additives
- Pesticides and pests
- Reporting and recordkeeping requirements
Dated: May 3, 2002.
Acting Director, Registration Division, Office of Pesticide Programs.
Summary of Petition
The petitioner summary of the pesticide petition is printed below as required by section 408(d)(3) of the FFDCA. The summary of the petition was prepared by the petitioner and represents the view of the petitioners. The summary may have been edited by EPA if the terminology used was unclear, the summary contained extraneous material for clarification, or the summary unintentionally made the reader conclude that the findings reflected EPA's position and not the position of the petitioner. The petition summary announces the availability of a description of the analytical methods available to EPA for the detection and measurement of the pesticide chemical residues or an explanation of why no such method is needed.
Dow AgroSciences LLC
EPA has received an amendment of the pesticide petition (PP 6F3344) from Dow AgroSciences LLC, 9330 Zionsville Road, Indianapolis, IN 46268 proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 by re-establishing the time-limited tolerances for residues of dichlormid in or on the raw agricultural commodity corn (forage, grain, stover) at 0.05 parts per million (ppm). Zeneca Ag Products requested these tolerances under the Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality Protection Act of 1996. A Notice of Filing was submitted and published in the Federal Register of September 16, 1998 (63 FR 49568) (FRL-6025-8). Based on the data submitted by Zeneca, the Agency determined that only time-limited tolerances for these residues could be established. The final rule was published on March 27, 2000 (65 FR 16143) (FRL-6498-7) with the time-limited tolerances expiring on March 27, 2002. To establish permanent tolerances the following studies are required: (1) Chronic Feeding Study in Dogs, (2) 2-Generation Reproductive Study in Rats, (3) General Metabolism Study, and (4) Subchronic Neurotoxicity Study, (5) various product chemistry data-color, physical state, water solubility; (6) animal metabolism studies, (7) crop field trials, and (8) rotational crop study (Confined Study). Zeneca committed to fulfill these data gaps. These time-limited tolerances expired on March 27, 2002.
On November 9, 2000, Zeneca Ag Products sold certain parts of its business to Dow AgroSciences. In connection with the sale, Zeneca Ag products tranferred all rights, title, and interest in dichlormid to Dow AgroSciences.Dow AgroSciences has petitioned the Agency to re-establish time-limited tolerances to allow for continued data generation. EPA has determined that the petition contains data or information regarding the elements set forth in section 408(d)(2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.
A. Residue Chemistry
1. Plant metabolism. The qualitative nature of the residue in plants is adequately understood based on a study depicting the metabolism of dichlormid in corn plants. The metabolism of dichlormid in corn is extensive and occurs via two metabolic pathways. In one pathway dichlormid is de-chlorinated and oxidized to generate N, N-diallyl glycolamide. An alternative pathway is the loss of an allyl group followed by oxidation to form dichloroacetic acid. There is also extensive incorporation into natural constituents. EPA has previously determined that dichlormid is the residue of concern for tolerance setting purposes.
2. Analytical method. An adequate enforcement method for residues of dichlormid in corn has been developed and validated by the Analytical Chemical Laboratory (ACL) of EPA. Analysis is carried out using gas chromatography with nitrogen selective thermionic detection. The limit of determination is 0.01 ppm.
3. Magnitude of residues. Fifteen field trials in field corn with dichlormid were submitted and reviewed. The submitted data support the time-limited tolerance level of 0.05 ppm for all corn commodities.
B. Toxicological Profile
1. Acute toxicity. Dichlormid has low acute toxicity as indicated by a range of studies including: A rat acute oral study with an LD50 of 2,816 milligram/kilogram (mg/kg) for males and 2,146 mg/kg for females, respectively; a rat acute dermal study with an LD50 of >2,040 mg/kg and a rabbit acute dermal study with an LD50 of >5,000 mg/kg; a rat inhalation study with an LD50 of >5.5 mg/L; a primary eye irritation study in the rabbit showing mild ocular irritation; a primary dermal irritation study in the rabbit showing severe skin irritation; and, a skin sensitization study which showed that dichlormid was a mild skin sensitizer in the guinea pig.
2. Genotoxicity. Dichlormid was not mutagenic in a range of in vitro assays including the Salmonella/microsome (Ames) assay, the human lymphocyte cytogenetic assay (both assays with and without metabolic activation) and an unscheduled DNA synthesis (DNA repair) assay in hepatocytes. In the L5178Y mouse lymphoma assay small increases in mutant frequency were observed only at cytotoxic concentrations and were not considered to be significant. In vivo, dichlormid was negative in the mouse micronucleus test and in the rat unscheduled DNA synthesis assay when tested at the maximum tolerated dose.
3. Reproductive and developmental toxicity. In a developmental toxicity study, rats were dosed orally by gavage with 0, 10, 40, or 160 mg/kg/day. The no observed adverse effect level (NOAEL) for maternal toxicity was 10 mg/kg/day based on a reduction in bodyweight gain and food consumption at 40 and 160 mg/kg/day. The developmental NOAEL was determined Start Printed Page 35999to be 40 mg/kg/day based on marginal fetotoxic effects, including extra 14th ribs probably due to maternal stress, slight sternebra misalignment and some centra unossified, at 160 mg/kg/day.
In a developmental toxicity study, rabbits were dosed orally by gavage with 0, 5, 30, or 180 mg/kg/day. The lowest observed adverse effect level (LOAEL) for both maternal and fetotoxicity was 180 mg/kg/day characterized by reduced body weight gain and food consumption and a small increase in post-implantation loss, an increased number of early resorptions, a decreased number of fetuses per litter and evidence of fetotoxicity (partial ossification and misshapen/fused sternebrae). The NOAEL for both maternal and developmental toxicity was 30 mg/kg/day.
In a 2-generation reproduction study in rats fed diets of 0, 15, 75, and 500 ppm of dichlormid, dietary administration of 500 ppm dichlormid (48.5 mg/kg/day) for two successive generations resulted in decreased bodyweights and increased liver weights in parents and pups of both generations. There were no effects on reproductive performance or reproductive organs at dose levels up to and including 500 ppm dichlormid. There were no toxicologically significant effects in parents or offspring at a dose level of 75 ppm dichlormid (>7.4 mg/kg/day).
4. Subchronic toxicity. In a subchronic toxicity study, groups of 12 male and 12 female Wistar-derived alpk:ApfSD rats were fed diets containing 0, 20, 200, or 2,000 ppm dichlormid for 90 days. Significant reductions in bodyweight gain and food consumption were seen in male and female rats receiving 2,000 ppm dichlormid and, to a lesser degree, in females at 200 ppm. The liver was identified as the principal target organ (enlargement, increased APDM activity in females, centrilobular hypertrophy, increased bile duct pigmentation) in the 2,000 ppm group. The NOAEL was 20 ppm (equivalent to approximately 1.8 mg/kg/day - see discussion under Chronic toxicity in Unit 2.B.5 of this document) and the LOAEL was 200 ppm, based on reduced bodyweight gain and food consumption and a marginal increase in APDM activity in females and liver enlargement in males.
In a 90-day dog feeding study, previously submitted and accepted by EPA, animals were dosed (4 dogs/sex/dose) at 0, 1, 5, 25, and 50 mg/kg/day. The NOAEL was 5 mg/kg/day and the LOAEL 25 mg/kg/day based on reduced bodyweight gain, increased liver weight and degenerative changes in voluntary muscle with an associated increase in plasma creatine kinase and alkaline phosphatase activity between 6 and 10 weeks.
In a 14-week rat inhalation study, groups of 18 male and 18 female Sprague-Dawley CD rats were subjected to a whole body exposure of 0, 2.0, 19.9, or 192.5 mg/m3 for 6 hours per day, 5 days per week. The NOAEL was 2.0 mg/m3 based on histopathologic tissue alterations to the nasal olfactory epithelium at 19.9 and 192.5 mg/m3, suggesting that dichlormid was a mild irritant to the nasal cavity. An increase in relative liver, kidney, and lung weights at 19.9 and 192.5 mg/m3 was not supported by gross or histopathological observations.
5. Chronic toxicity. Rats (64/sex/group) were fed diets containing 0, 20, 100, or 500 ppm dichlormid (0, 1.3, 6.5, 32.8 mg/kg/day for males and 0, 1.5, 7.5, 37.1 mg/kg/day for females) for up to 2 years. At 500 ppm in both males and females, there were treatment-related effects on growth and food consumption, minor reductions in plasma triglycerides and in males, increased liver weights, accompanied by hepatocyte vaculolation and pigmentation effects. In females there was a slight overall increase in malignant tumors, primarily uterine adenocarcinomas, at 500 ppm, but this specific increase was within the spontaneous incidence observed in historical data. It was concluded that there was no evidence of oncogenicity associated with dichlormid treatment. The NOAEL for chronic toxicity was 100 ppm (6.5 and 7.5 mg/kg/day for males and females, respectively).
In an 18-month oncogenicity study, mice (55/sex/group) were fed dichlormid at doses of 0, 10, 50, or 500 ppm (0, 1.4, 7.0, 70.7 mg/kg for males and 0, 1.84, 9.2, 92.4 mg/kg for females). At 500 ppm there was a slight increase in mortality for females from week 64 onwards, and bodyweights and food utilization were reduced in males, and, to a lesser extent in females. Also, mice fed 500 ppm dichlormid showed non-neoplastic changes which were minor and consisted of changes in severity or incidence of common spontaneous findings. Based on these effects, the chronic NOAEL was 50 ppm (7.0 and 9.2 mg/kg/day for males and females, respectively). There was a marginal increase in Harderian gland adenomas in males at 500 ppm, but this was considered to reflect the variable spontaneous tumor rate seen in this strain and sex of mouse. It was concluded there was no evidence of oncogenicity associated with dichlormid treatment.
Based on available chronic toxicity data, the Reference Dose (RfD) for dichlormid is 0.07 mg/kg/day. This RfD is based on the 2-year feeding study in rats with an NOAEL of 7 mg/kg/day. An uncertainty factor of 100 was used to account for interspecies extrapolation and intraspecies variability. The 2-year rat study is consistent with, but supersedes, the 90-day rat study. The 2-year rat NOAEL of 7 mg/kg/day lies between 1.8 and 18 mg/kg/day derived from the NOAEL and LOAEL figures of 20 and 200 ppm, respectively, for the most recent 90-day rat study. Thus, the overall NOAEL in the rat for both chronic and subchronic exposure should be regarded as 7 mg/kg/day. Based on the proposed Guidelines for Carcinogenic Risk Assessment (July 1999), dichlormid is not likely to be a human carcinogen and a margin of exposure (MOE) approach should be used for human risk assessment.
6. Animal metabolism. Dichlormid was well absorbed, extensively metabolized and eliminated mainly in the urine within 24 hours. A significant proportion of the dose, up to 11%, was exhaled as CO2. Two routes of biotransformation have been identified. One route involved the formation of an alcohol N, N-diallylglycolamide before subsequent oxidation to N, N-diallyloxamic acid, a major metabolite present in the urine and feces of both sexes. N, N-diallylglycolamide also undergoes further biotransformation to minor dechlorinated metabolites. In the second metabolic pathway dichloroacetic acid present in the urine of both sexes is formed either directly from dichlormid or indirectly by transformation of N-allyl-2,2-dichloro-N-(2,3-dihydroxypropyl)acetamide. Entero-hepatic recirculation plays a major role in the distribution, metabolism and excretion of dichlormid. The elimination as CO2, the even elimination in urine over the first 24 hours, and wide distribution of retained radioactivity indicates some incorporation into endogenous metabolic processes.
7. Metabolite toxicology. No unique plant or soil metabolites have been identified that warrant a separate toxicological assessment.
8. Endocrine disruption. There is no overall trend in the toxicology database that indicates that dichlormid would have endocrine disrupting activity. The mammalian and ecotoxicology databases do not indicate significant adverse effects associated with endocrine disrupter activity.Start Printed Page 36000
C. Aggregate Exposure
1. Food. In conducting a chronic dietary risk assessment, reference is made to the conservative assumptions made by EPA: Dichlormid time-limited tolerances (65 FR 16143, March 27, 2000), 100% crop-treated, and that all commodities contain residues at the tolerance or proposed tolerance. The analysis was determined using the Novigen Dietary Exposure Evaluation Model (DEEM Version 6.2) software and the United States Department of Agriculture (USDA) Nationwide Continuing Surveys of Food Intake by Individuals (CSFII) survey that was conducted from 1994 through 1996.
2. Drinking water. Dichlormid is very rapidly degraded in soil (laboratory measured aerobic half-life of 8 days) and applied at a maximum rate of 0.5 lb/acre, so despite only exhibiting moderate adsorption to soil (Koc 36-49), the leaching potential for dichlormid to reach ground water is expected to be low. The impact of the interactive processes of adsorption and degradation on leaching have been assessed using EPA mathematical models of pesticide movement in soil. Drinking water estimate concentrations (DWEC) were calculated for ground water using Screening Concentration in Ground Water (SCI-GROW) modeling, and surface water estimate concentrations were calculated using Generic Estimated Environmental Concentration (GENEEC) modeling. These models predict a ground water concentration of 0.05 ppb and surface water concentrations of 27.3 ppb for an instantaneous peak and 26.9 ppb for a 56-day average. However, the interim Agency policy in March 2000, allowed the average 56-day GENEEC values to be divided by 3 (9.0 ppb) to obtain a value for chronic risk assessments. Drinking water levels of concern (DWLOC) were then calculated for both chronic and acute exposure. These DWLOC values are all comfortably below the water exposure estimates obtained from the screening level model GENEEC. Dow AgroSciences does not expect exposure to dichlormid residues in drinking water to be a concern.
3. Non-dietary exposure. The general population is not expected to be exposed to dichlormid through non-dietary routes since dichlormid is used only on agricultural crops and is not used in or around the home.
D. Cumulative Effects
The potential for cumulative effects of dichlormid and other substances that have a common mechanism of toxicity have been considered. There is no reliable information to suggest that dichlormid has any toxic effects that arise from toxic mechanisms common to other substances. Therefore, a consideration of common mechanism and cumulative effects with other substances is not appropriate for dichlormid.
E. Safety Determination
1. U.S. population—i. Chronic risk. Using the conservative exposure assumptions described earlier, and based on the completeness and reliability of the toxicity data base for dichlormid, the theoretical maximum residue concentration (TMRC) for the general U.S. population is calculated to be 0.00009 mg/kg/day, or 4.1% of the cPAD (0.0022 mg/kg/day). The most highly exposed subgroup are children aged 1-6 years with a TMRC of 0.000211 mg/kg/day, or 9.6% of the cPAD. The RfD represents the level at or below which daily aggregate dietary exposure over a lifetime will not pose appreciable risks to human health. Dow AgroSciences concludes that there is a reasonable certainty that no harm will result from aggregate exposure to dichlormid residues.
ii. Acute risk. The acute toxicity of dichlormid is low and there are no concerns for acute-dietary, occupational, or non-occupational exposures to dichlormid.
2. Infants and children. In assessing the potential for additional sensitivity of infants and children to residues of dichlormid, data from developmental toxicity studies in the rat and rabbit have been considered. The developmental toxicity studies are designed to evaluate adverse effects on the developing organism resulting from maternal pesticide exposure during gestation. There was no evidence to suggest that dichlormid was a developmental toxicant in either the rat or rabbit. It was also observed that there was no risk below maternally toxic doses as the NOAEL for developmental effects in the rat was 40 mg/kg/day, compared to the maternal NOAEL of 10 mg/kg/day and, in the rabbit study, the NOAEL for both maternal and developmental effects was 30 mg/kg/day. EPA previously concluded in the March 27, 2000 Federal Register that the additional 10x safety factor should be retained due to the qualitative evidence of increased susceptibility demonstrated following in utero exposure in the prenatal developmental toxicity in rabbits and an incomplete toxicity data base. It should be noted that in the rabbit developmental toxicity study, the LOAEL for both maternal and developmental toxicity was 180 mg/kg/day. The effects on resorptions at this dose were observed in dams which showed an average weight loss (-3.8 gram) during the treatment period compared with an average weight gain in controls of 272 gram. Also, a multigeneration study has now been completed and, therefore, an additional safety factor should no longer be necessary.
Additional uncertainty factors are not warranted for the safety of infants and children as reliable data support the appropriate use of a 100-fold uncertainty factor (MOE) to account for interspecies extrapolation and intraspecies variability. However, using the conservative exposure assumptions above for the determination in the general population, it is concluded that the percentage of cPAD that will be utilized by aggregate exposure to dichlormid is 9.6% for children aged 1-6 years (the group at highest risk). Therefore, based on the completeness and reliability of the toxicity database and the conservative exposure assessment, it is concluded that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to dichlormid residues.
F. International Tolerances
A Maximum Residue Level has not been established for dichlormid by the Codex Alimentarius Commission.End Supplemental Information
[FR Doc. 02-12849 Filed 5-21-02; 8:45 am]
BILLING CODE 6560-50-S