E4-463. Endosulfan; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

This notice announces the initial filing of a pesticide petition proposing the establishment of regulations for residues of a certain pesticide chemical in or on various food commodities.

DATES:

Comments, identified by docket ID number OPP-2004-0004, must be received on or before April 5, 2004.

ADDRESSES:

Comments may be submitted electronically, by mail, or through hand delivery/courier. Follow the detailed instructions as provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT:

Dana Pilitt, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: [phone]; e-mail address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

• Crop protection (NAICS 111)
• Animal production (NAICS 112)
• Food manufacturing (NAICS 311)
• Pesticide manufacturing (NAICS 32532)

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 this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

1. Docket. EPA has established an official public docket for this action under docket ID number OPP-2004-0004. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although, a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is [phone].

2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the “Federal Register” listings at http://www.epa.gov/​fedrgstr/​.

An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/​edocket/​ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although, not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B.1. Once in the system, select “search,” then key in the appropriate docket ID number.

Certain types of information will not be placed in the EPA Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA Dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. Although, not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B. EPA intends to work towards providing electronic access to all of the publicly available docket materials through EPA's electronic public docket.

For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or on paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket.

Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the docket will be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff.

C. How and to Whom Do I Submit Comments?

You may submit comments electronically, by mail, or through hand delivery/courier. To ensure proper receipt by EPA, identify the appropriate docket ID number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked “late.” EPA is not required to consider these late comments. If you wish to submit CBI or information that is otherwise protected by statute, please follow the instructions in Unit I.D. Do not use EPA Dockets or e-mail to submit CBI or information protected by statute.

1. Electronically. If you submit an electronic comment as prescribed in this unit, EPA recommends that you include your name, mailing address, and an e-mail address or other contact information in the body of your comment. Also, include this contact information on the outside of any disk or CD ROM you submit, and in any cover letter accompanying the disk or CD ROM. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. EPA's policy is that EPA will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment.

i. EPA Dockets. Your use of EPA's electronic public docket to submit comments to EPA electronically is EPA's preferred method for receiving comments. Go directly to EPA Dockets at http://www.epa.gov/​edocket/​, and follow the online instructions for submitting comments. Once in the system, select “search,” and then key in docket ID number OPP-2004-0004. The system is an “anonymous access” system, which means EPA will not know your identity, e-mail address, or other contact information unless you provide it in the body of your comment.

ii. E-mail. Comments may be sent by e-mail to [e-mail], Attention: Docket ID number OPP-2004-0004. In contrast to EPA's electronic public docket, EPA's e-mail system is not an “anonymous access” system. If you send an e-mail comment directly to the docket without going through EPA's electronic public docket, EPA's e-mail system automatically captures your e-mail address. E-mail addresses that are automatically captured by EPA's e-mail system are included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket.

iii. Disk or CD ROM. You may submit comments on a disk or CD ROM that you mail to the mailing address identified in Unit I.C.2. These electronic submissions will be accepted in WordPerfect or ASCII file format. Avoid the use of special characters and any form of encryption.

2. By mail. Send your comments to: Public Information and Records Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001, Attention: Docket ID number OPP-2004-0004.

3. By hand delivery or courier. Deliver your comments to: Public Information and Records Integrity Branch (PIRIB), Office of Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket ID number OPP-2004-0004. Such deliveries are only accepted during the docket's normal hours of operation as identified in Unit I.B.1.

D. How Should I Submit CBI to the Agency?

Do not submit information that you consider to be CBI electronically through EPA's electronic public docket or by e-mail. You may claim information that you submit to EPA as CBI by marking any part or all of that information as CBI (if you submit CBI on disk or CD ROM, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is 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 docket and EPA's electronic public docket. If you submit the copy that does not contain CBI on disk or CD ROM, mark the outside of the disk or CD ROM clearly that it does not contain CBI. Information not marked as CBI will be included in the public docket and EPA's electronic public docket without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person listed 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.

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 ID 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 Cosmetic Act (FFDCA), 21 U.S.C. 346a. EPA has determined that this petition contains data or information regarding the elements set forth in FFDCA 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.

List of Subjects

• Environmental protection
• Agricultural commodities
• Feed additives
• Food additives
• Pesticides and pests
• Reporting and recordkeeping requirements

Dated: February 17, 2004.

Lois Rossi,

Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

The petitioner's summary of the pesticide petition is printed below as required by FFDCA section 408(d)(3). The summary of the petition was prepared by Endosulfan Task Force and represents the view 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.

Endosulfan Task Force

PP 3E6757

EPA has received pesticide petition (PP 3E6757) from the Endosulfan Task Force, c/o Dr. Bert Volger, Ceres International LLC, 1087 Heartsease Drive, West Chester, PA 19382 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 establishing a tolerance for the total residues of endosulfan (6,7,8,9,10,10-hexachloro-1,5,5a,6,9,9a-hexahydro-6,9-methano-2,4,3-benzodioxathiepin-3-oxide expressed as the sum of α- and β-endosulfan), and its metabolite, endosulfan-sulfate (6,7,8,9,10,10-hexachloro-1,5,5a,6,9,9a-hexahydro-6,9-methano-2,4,3-benzodioxathiepin-3-dioxide) in or on the raw agricultural commodity, imported green coffee beans, at 0.2 parts per million (ppm). 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 support granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

1. Plant metabolism. The metabolism of endosulfan in plants and animals is adequately understood for the purpose of the proposed tolerance. Acceptable metabolism studies depicting the qualitative nature of the residues in apple, cucumber, and lettuce have demonstrated that the residues of concern are α- and β-endosulfan, and endosulfan sulfate.

2. Analytical method. Adequate analytical methodology using gas liquid chromatography/electron capture (GLC/EC) detection is available for enforcement purposes. The Pesticide Analytical Manual (PAM) Vol.II lists Methods I, II and III for determination of endosulfan and/or its sulfate metabolite. The limit of detection was validated for each endosulfan isomer and its sulfate metabolite at 0.01 ppm for green coffee beans and its processed fractions, roasted beans and instant coffee.

3. Magnitude of residues. A total of 10 field trials were conducted in the major coffee producing countries of Brazil (3), Colombia (3), Guatemala (2), and Mexico (2) to evaluate the quantity of endosulfan residues in or on dried green coffee beans following application of 700 grams endosulfan per hectare, 3 times during growing season with the last application 30 days before harvest. The highest total endosulfan residues were measured in one dried green bean sample at 0.11 ppm. In addition, there were two trials conducted at a single 3X exaggerated rate (2,100 g/ha) for processing purposes. There were no detectable residues < 0.01 ppm of α-endosulfan, β-endosulfan and endosulfan sulfate in ground roasted beans or instant coffee. Therefore, the data support the requested tolerance.

B. Toxicological Profile

1. Acute toxicity. Endosulfan is highly toxic following acute oral exposure and moderately toxic following acute inhalation exposure. In rats, oral median lethal doses (LD₅₀ values) are 82 milligrams/kilogram (mg/kg) (males) and 30 mg/kg (females). Medium lethal concentrations (LC₅₀ values) in rats following acute inhalation exposure range from 0.16 to 0.5 milligram liter (mg/L). Endosulfan is considerably less lethal, however, following acute dermal exposure (LD₅₀ is 2 grams/kilogram (g/kg). Endosulfan is an eye irritant in rabbits (Toxicity Category I) but is not a dermal irritant or sensitizer.

2. Genotoxicty. Endosulfan does not show any mutagenic potential. The submitted mutagenicity studies have satisfied the data requirements for mutagenicity testing, and there is no concern for a mutagenic effect in somatic cells. In the in vitro or in vivo mutagenicity studies, both the mouse lymphoma forward mutation assay and the unscheduled DNA synthesis assay were negative.

3. Reproductive and developmental toxicity. A developmental toxicity study in rats indicated a maternal no observed adverse effect level (NOAEL) of 2.0 mg/kg body weight/day (bwt/day) based on increased mortality, tonoclonic convulsions, increased salivation and decreased body weight gains and food consumption at 6.0 mg/kg bwt/day. The developmental NOAEL was 2.0 mg/kg bwt/day, based on a slight increase in skeletal variations and occurrence of fetuses/litter weighing less than 3 grams at the maternally toxic dose of 6.0 mg/kg bwt/day. An oral developmental toxicity study in rabbits showed a maternal NOAEL of 0.7 mg/kg bwt/day and a maternal lowest observed adverse effect level (LOAEL) of 1.8 mg/kg bwt/day, based on decreased body weight, increased mortality, convulsions, rapid breathing, salivation and hyperactivity during the dosing period. A fetal NOAEL of greater than 1.8 mg/kg bwt/day was also observed in this study. A two-generation reproduction study in rats indicated parental and offspring NOAELs of 1.2 mg/kg bwt/day, based on reductions in body weight in adults and increased pituitary weights in the female pups of the F0 generation and increased uterine weights in the F1b generation at 6.2 mg/kg bwt/day.

4. Subchronic toxicity. In a 13-week feeding study in rats, endosulfan demonstrated a NOAEL of 0.5 mg/kg bwt/day, based on kidney abnormalities and increased spleen weights in male rats at 1.5 mg/kg bwt/day. In a 13-week feeding study in mice the resulting NOAEL was 2.1 mg/kg bwt/day, based on increased mortality in males and females seen at 7.3 mg/kg bwt/day. A 6-month toxicity feeding study in dogs established a NOAEL of 5 mg/kg bwt/day. The LOAEL was 15 mg/kg bwt/day based on clinical signs of neurotoxicity and gastrointestinal disturbances.

Two subchronic dermal studies were conducted with endosulfan. In the first study endosulfan was applied dermally 5 days a week over 30 days. The resulting NOAELs were established at 12 mg/kg/day in females and 96 mg/kg/day in males. The LOAELs were determined to be 48 mg/kg/day in females and 192 mg/kg/day in males based on increased mortality in males and females and increased serum cholinesterase inhibitor (ChE) activity inhibition in males. In the second study endosulfan was administered dermally 5 days a week over 30 days. The LOAELs were determined to be 81 mg/kg/day in males and 27 mg/kg/day in females based on increased mortality. The NOAELs were established at 27 mg/kg/day in males and 9 mg/kg/day in females. The dose and endpoint selected for risk assessment was dermal NOAEL = 12 mg/kg/day based on mortality in female rats at 27 mg/kg/day LOAEL. The endpoints from both 21-day dermal toxicity studies discussed above were considered in arriving at the NOAEL and LOAEL. In a subchronic inhalation study conducted with endosulfan, rats were exposed 6 hours per day, 5 days per week for a total of 21 exposures over 29 days. The NOAEL was 0.001 mg/L (0.2 mg/kg bwt/day), based on decreased body weight gain and leukocyte counts in the males and increased creatinine values in the females at 0.002 mg/L (0.4 mg/kg bwt/day).

5. Neurotoxicity. In an acute neurotoxicity study with endosulfan the resulting NOAEL was 12.5 mg/kg for males and 1.5 mg/kg for females. The LOAEL was 25 mg/kg for males based on increased incidences of stilted gait, squatting posture, and irregular respiration, as well as decreased spontaneous activity. The LOAEL was 3 mg/kg for females, based on an increased incidence of stilted gait, squatting posture, straddled hindlimbs, irregular respirations, panting and bristled coat and decreased spontaneous activity.

6. Chronic toxicity. A 12-month chronic feeding study in dogs established a NOAEL of 0.65 and 0.57 mg/kg bwt/day in males and females, respectively. The LOAEL for this study was established at 1.75 mg/kg bwt/day, based on decreased body weight gain in males and increased incidences of neurological findings in males and females. A 24-month chronic feeding/carcinogenicity study in rats demonstrated a NOAEL of 0.6 mg/kg bwt/day and an average LOAEL of 3.4 mg/kg bwt/day, based on decreased body weight gains and increased incidences of marked progressive glomerulonephrosis in males and females, enlarged kidneys in females and blood vessel aneurysms in males. A 24-month carcinogenicity study in mice was conducted. The NOAEL was 0.9 mg/kg/bwt/day, based on increased incidences of mortality in females at 2.65 mg/kg. Under the conditions of these studies, there was no evidence of carcinogenic potential.

7. Animal metabolism. Following absorption from the oral or dermal exposure routes endosulfan is partially metabolized, primarily to endosulfan sulfate. Minor metabolites include endosulfan diol, endosulfan ether, endosulfan α-hydroxy ether, and endosulfan lactone. None of the minor metabolites of endosulfan are believed to be of toxicological concern. Endosulfan and its metabolites partition and accumulate predominately in the kidney and liver. Following dietary exposure to endosulfan, a large amount of endosulfan sulfate is recovered in the liver, small intestine and visceral fat, and only a trace amount is recovered in muscle tissue. Endosulfan and its metabolites are excreted in both the urine and feces, the latter being the predominant route of excretion. Most of an absorbed dose of endosulfan is excreted within a few days to a few weeks, depending upon dose and route of exposure.

8. Metabolite toxicology. The major metabolite of concern for endosulfan is endosulfan sulfate. This metabolite is assumed to have equal toxicity to the parent.

9. Endocrine disruption. There is no evidence of endocrine effects in any of the studies conducted with endosulfan, thus, there is no indication at this time that endosulfan causes endocrine effects.

C. Aggregate Exposure

1. Dietary exposure. Permanent tolerances have been established for the total residues of the insecticide endosulfan (6,7,8,9,10,10-hexachloro-1,5,5a,6,9,9a-hexahydro-6,9-methano-2,4,3-benzodioxathiepin-3-oxide, expressed as the sum of α- and β-endosulfan), and its metabolite, endosulfan-sulfate (6,7,8,9,10,10-hexachloro-1,5,5a,6,9,9a-hexahydro-6,9-methano-2,4,3-benzodioxathiepin-3-dioxide) in or on a variety of raw agricultural and livestock commodities (40 CFR 180.182). The chronic assessment is based on a chronic population adjusted dose (cPAD) of 0.0006 mg/kg bwt/day. The acute assessment is based on an acute PAD of 0.0015 mg/kg bwt/day for all population subgroups.

i. Food. Chronic and acute dietary exposure estimates resulting from the proposed import tolerance and all currently registered uses of endosulfan, except the pending deletions of succulent beans, succulent peas, grapes, spinach, and pecans are well within acceptable limits for all sectors of the population. Potential dietary exposures from food were estimated using the Dietary Exposure Evaluation Model (DEEM^TM) software system (Exponent, Inc.) and the 1989-1992 USDA consumption data. For the chronic analysis, mean residue values were calculated from the appropriate field trials or monitoring studies conducted for endosulfan, which were reviewed in EPA's most recent dietary risk assessment (Endosulfan reregistration eligibility decisions (RED), November 2002). For the acute analysis, the entire distribution of field trial residue or monitoring values were used for non-blended and partially blended commodities, and the mean value used for blended commodities. Processing factors were obtained from good laboratory practice (GLP) processing studies for the appropriate commodities. Percent crop treated values were obtained from the RED dietary assessment. The dietary risks (acute, chronic) concerning the tolerance reassessment indicate the following: for the chronic analysis the most highly exposed sub-population was children 1-2 years old utilizing 19.5% of the cPAD or 0.000117 mg/kg bwt/day. The U.S. population utilized 6.4% of the cPAD or 0.000038 mg/kg bwt/day. For the acute analysis the most highly exposed sub-population was again children 1-2 years old at 84.9% of the aPAD or 0.001274 mg/kg bwt/day, and the U.S. population at 52.6% of the aPAD or 0.000790 mg/kg bwt/day. Actual exposures are likely to be much less because of the conservative assumptions incorporated in this analysis. The calculated residue contribution from imported coffee is negligible.

ii. Drinking water. Since the proposed tolerance is for imported coffee beans, there is no potential exposure from drinking water.

2. Non-dietary exposure. Endosulfan is currently not registered for use on any sites that would result in residential exposure.

D. Cumulative Effects

To our knowledge there are currently no available data or other reliable information indicating that any toxic effects produced by endosulfan would be cumulative with those of other pesticides; thus only the potential risks of endosulfan have been considered in this assessment of its aggregate exposure. Once the final framework for cumulative risk assessments is available, the Agency might identify other substances that share a common mechanism of toxicity with endosulfan.

E. Safety Determination

1. U.S. population. Using the assumptions and data described above and based on the completeness and reliability of the toxicity data, it can be concluded that the residue contribution of the proposed import tolerance is negligible. The chronic dietary exposure will utilize at most 6.4% of the cPAD, and 52.6% of the aPAD for the U.S. population. The actual exposure, both acute and chronic, is likely to be much less as more realistic data and models are developed. EPA generally has no concern for exposures below 100% of the PAD because the PAD represents the level at or below which daily aggregate exposure over a lifetime will not pose appreciable risk to human health. The Endosulfan Task Force concludes, there is reasonable certainty that no harm will occur to the U.S. population from acute or chronic aggregate exposure (food and drinking water) to residues of endosulfan in view of the proposed tolerance for imported coffee beans.

2. Infants and children. The EPA HIARC has chosen to retain the 10X Food Quality Protection Act (FQPA) Safety factor for endosulfan. Using the assumptions and data described in the exposure section above, the percent of the cPAD that will be used for exposure to residues of endosulfan in food for children 1-2 yrs (the most highly exposed sub-population) is 19.4%. Infants utilize 8.9% of the cPAD. For the acute assessment children 1-2 yrs utilize 84.9% of the aPAD and infants utilize 71.7% of the aPAD. The proposed import tolerance will have minimal impact on the dietary risk. Therefore, there is a reasonable certainty that no harm will occur to infants and children from aggregate exposure (food and drinking water) to residues of endosulfan from imported coffee beans.

F. International Tolerances

A codex maximum residue level MRL of 0.1 ppm has been established for residues of endosulfan in or on coffee beans.