00-17755. 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 control number PF-952, must be received on or before August 14, 2000.

ADDRESSES:

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 PF-952 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:

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

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

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

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in the table could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

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

1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/​. To access this document, on the Home Page select “Laws and Regulations” 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 PF-952. 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 [phone].

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 PF-952 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 [phone].

3. Electronically. You may submit your comments electronically by e-mail to: “[e-mail],” 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 PF-952. 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.

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.

List of Subjects

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

Dated: July 5, 2000.

Peter Caulkins,

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 petitioner. EPA is publishing the petition summary verbatim without editing in any way. 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.

Zeneca Ag. Products

9F6032

EPA has received a pesticide petition 9F6032 from Zeneca Ag. Products, 1800 Concord Pike, P.O. Box 15458, Wilmington, DE 19850-5458 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 tolerances for residues of sulfosate (the trimethylsulfonium salt of glyphosate, also known as glyphosate-trimesium) in or on the raw agricultural commodities (RAC) cotton gin byproducts at 120 parts per million (ppm) (of which no more than 35 ppm is trimethylsulfonium (TMS)); cotton undelinted seed at 40 ppm (of which no more than 10 ppm is TMS); leaves of root and tuber vegetables group (except radish) at 0.25 ppm (of which no more than 0.2 ppm is TMS); pistachio at 0.05 ppm; potato flakes at 2 ppm (of which no more than 1.5 ppm is TMS); radish roots at 16 ppm (of which no more than 15 ppm is TMS); radish tops at 10 ppm (of which no more than 8 ppm is TMS); root vegetables subgroup (except radish) at 0.15 ppm (of which no more than 0.1 ppm is TMS); sorghum grain at 35 ppm (of which no more than 15 ppm is TMS); sorghum forage at 0.2 ppm (of which no more than 0.1 ppm is TMS); sorghum stover at 140 ppm (of which no more than 60 ppm is TMS); sweet corn forage at 20 ppm (of which no more than 5 ppm is TMS); sweet corn, kernels + cob with husks removed at 0.15 ppm (of which no more than 0.1 ppm is TMS); sweet corn stover at 165 ppm (of which no more than 65 ppm is TMS); tuberous and corm vegetables subgroup at 1 ppm (of which no more than 0.5 ppm is TMS); and to increase the tolerance in poultry meat by-products to 0.5 ppm and in milk to 2 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 sulfosate has been studied in corn, grapes, and soybeans. EPA has concluded that the nature of the residue is adequately understood and that the only residues of concern are the parent ions N-(phosphonomethyl)-glycine anion (PMG) and TMS.

2. Analytical method. Gas chromatography/mass selective (GC/MS) detector methods have been developed for PMG analysis in crops, animal tissues, milk, and eggs. Gas chromatography detection methods have been developed for TMS in crops, animal tissues, milk, and eggs.

3. Magnitude of residues—i. Magnitude of residues in crops—a. Cotton. Residue data are available for sulfosate in a total of 13 trials conducted in 5 EPA regions and 11 different states. The proposed tolerance of 40 ppm (of which no more than 10 ppm is TMS) for undelinted cotton seed and the proposed tolerance of 120 ppm (of which no more than 35 ppm is TMS) for cotton gin by-products will accommodate any residue resulting from the proposed use pattern.

Cotton seed for processing were obtained and samples were processed into hulls, meal, and refined oil. There was no concentration in the processed fractions. No tolerances are required for cotton hulls, meal, or refined oil at the proposed use rates.

b. Sorghum. Residue data are available for sulfosate in a total of 12 trials conducted in 6 EPA regions and 8 different states. The proposed tolerance of 0.2 ppm (of which no more than 0.1 ppm is TMS) for sorghum forage; the proposed tolerance of 35 ppm (of which no more than 15 ppm is TMS) for sorghum grain; and the proposed tolerance of 140 ppm (of which no more than 60 ppm is TMS) for sorghum stover will accommodate any residue resulting from the proposed use pattern. Aspirated grain fractions (AGF) were also collected. Analysis of the treated samples showed that residue of both TMS and PMG concentrated in AGF, but the combined levels are less than the existing tolerance in 40 CFR 180.489 for aspirated grain fractions. No change in the existing tolerance is required.

c. Sweet corn. Residue data are available for sulfosate in a total of 12 trials conducted in 7 EPA regions and 11 different states. The proposed tolerance of 20 ppm (of which no more than 5 ppm is TMS) for sweet corn forage; the proposed tolerance of 0.15 ppm (of which no more than 0.1 ppm is TMS) for sweet corn kernels plus cobs with husks removed; and the proposed tolerance of 165 ppm (of which no more than 65 ppm is TMS) for sweet corn stover will accommodate any residue resulting from the proposed use pattern.

d. Leaves of root and tuber vegetables group (except radish). Residue data are available for sulfosate in a total of 15 trials in the representative commodties of turnips and sugar beets in 8 EPA regions and 12 different states. Residue data are also available for sulfosate in a total of five trials in radish conducted in four EPA regions and four different states. The proposed tolerance of 0.25 ppm (of which no more than 0.2 ppm is TMS) for the leaves of the root and tuber vegetable group (except radish) and the proposed tolerance of 10 ppm (of which no more than 8 ppm is TMS) for radish tops will accommodate any residue resulting from the proposed use pattern.

e. Root vegetables subgroup 1-A (except radish). Residue data are available for sulfosate in a total of 20 trials in the representative commodities of sugar beets, radish, and carrots in 8 EPA regions and 10 different states. Residue data are also available for sulfosate in a total of six trials in turnips conducted in five EPA regions and six different states. The proposed tolerance of 0.15 ppm (of which no more than 0.1 ppm is TMS) for the root vegetables subgroup (except radish) and the proposed tolerance of 16 ppm (of which no more than 15 ppm is TMS) for radish roots will accommodate any residue resulting from the proposed use pattern.

Sugar beets treated at a 5x exaggerated rate for processing were obtained. No residues above the limit of quantitation (LOQ) were found in any of the sugar beet magnitude of the residue studies nor in the 5x exaggerated rate treated sugar beet samples so a processing study is not required. No tolerances are required for sugar beet refined sugar, dried pulp, or molasess at the proposed use rates.

f. Tuberous and corm vegetables subgroup 1-D. Residue data are available for sulfosate in a total of 12 trials in the representative commodity, potatoes, in 7 EPA regions and 10 different states. The proposed tolerance of 1 ppm (of which no more than 0.5 ppm is TMS) for the tuberous and corm vegetables subgroup will accommodate any residue resulting from the proposed use pattern.

Potatoes for processing were obtained and samples were processed into potato flakes, chips, and wet peel. Analysis of the treated samples showed that residue of TMS concentrated in potato flakes. The proposed tolerance for potato flakes of 2 ppm (of which no more than 1.5 ppm is TMS) is adequate to accommodate any residues arising from this use pattern in potatoes. No tolerances are required for potato chips and potato wet peel.

g. Pistachio. Residue data are available for sulfosate for representative commodities of the nut crop group (pecans, walnuts, and almonds). Residues were below the LOQ of 0.05 ppm in all samples. These data are sufficient to support a tolerance in pistachio. The proposed tolerance for pistachio of 0.05 ppm is the same as the established tolerance in 40 CFR 180.489 for the tree nut group and is adequate to accommodate any residues arising from this use pattern in pistachios.

ii. Magnitude of residue in animals—a. Ruminants. The maximum dietary burden in dairy cows results from a diet comprised of 20% AGF, 60% wheat forage, 15% sweet corn stover, and 5% cotton gin by-products for a total dietary burden of 427 ppm. The maximum dietary burden in beef cows results from a diet comprised of 20% AGF, 25% sweet corn stover, 25% sorghum grain, 25% wheat forage, and 5% cotton gin by-products for a total dietary burden of 438 ppm. Comparison to a ruminant feeding study at a dosing level of 1,000 ppm indicates that the appropriate tolerance levels resulting from these proposed additional uses are covered by existing tolerances in 40 CFR 180.489, except milk. The appropriate tolerance for milk is 2 ppm.

b. Poultry. The maximum dietary burden in poultry results from a diet comprised of 80% sorghum grain and 20% soybean hulls for a total dietary burden of 43 ppm. Comparison to a poultry feeding study at a dosing level of 50 ppm indicates that the appropriate tolerance levels are covered by existing tolerances in 40 CFR 180.489, except poultry meat by-products. The appropriate tolerance for poultry meat by-products is 0.5 ppm.

B. Toxicological Profile

1. Acute toxicity. Several acute toxicology studies have been conducted placing technical grade sulfosate in toxicity category III and IV.

2. Genotoxicty. The toxicological endpoints for sulfosate are discussed in Unit 3.B. of the Federal Register notice of April 8, 1999 (64 FR 17171) (FRL-6071-2).

3. Reproductive and developmental toxicity. The toxicological endpoints for sulfosate are discussed in Unit B.3. of the Federal Register notice of April 8, 1999 (64 FR 17171).

4. Subchronic toxicity. The toxicological endpoints for sulfosate are discussed in Unit 3.B. of the Federal Register notice of April 8, 1999 (64 FR 17171).

5. Chronic toxicity. The toxicological endpoints for sulfosate are discussed in Unit 3.B. of the Federal Register notice of April 8, 1999 (64 FR 17171).

6. Animal metabolism. The metabolism of sulfosate has been studied in animals. The residues of concern for sulfosate in meat, milk, and eggs are the parent ions PMG and TMS only.

7. Metabolite toxicology. There are no metabolites of toxicological concern. Only the parent ions, PMG and TMS, are of toxicological concern.

8. Endocrine disruption. Current data suggest that sulfosate is not an endocrine disruptor.

C. Aggregate Exposure

1. Dietary exposure—i. Food. For the purposes of assessing the potential dietary exposure, Zeneca has utilized the tolerance level for all existing and pending tolerances; and the proposed maximum permissible levels of 120 ppm for cotton gin by-products; 40 ppm for cotton undelinted seed; 0.25 ppm for leaves of root and tuber vegetables group (except radish); 0.05 ppm for pistachio; 2 ppm for potato flakes; 16 ppm for radish roots; 10 ppm for radish tops; 0.15 ppm for root vegetables subgroup (except radish); 35 ppm for sorghum grain; 0.2 ppm for sorghum forage; 140 ppm for sorghum stover; 20 ppm for sweet corn forage; 0.15 ppm for sweet corn, kernels + cob with husks removed; 165 ppm for sweet corn stover; 1 ppm for tuberous and corm vegetables subgroup; 0.5 ppm in poultry meat by-products; 2 ppm in milk; and 100% crop treated acreage for all commodities. Assuming that 100% of foods, meat, eggs, and milk products will contain sulfosate residues and those residues will be at the level of the tolerance results in an overestimate of human exposure. This is a very conservative approach to exposure assessment.

a. Chronic exposure. For all existing and pending tolerances and the proposed maximum permissible levels proposed in this notice of filing, the potential exposure for the U.S. population is 0.04 milligrams/kilograms body weight per day (mg/kg/bwt/day) (17.6% of RfD). Potential exposure for children's population subgroups range from 0.02 mg/kg bwt/day (7.8% of RfD) for nursing infants (<1 year old) to 0.12 mg/kg bwt/day (47.8%) for children 1-6 years old. The chronic dietary risk due to food does not exceed the level of concern (100%).

b. Acute exposure. The exposure to the most sensitive population subgroup, non-nursing infants, is 23.5% of the acute RfD at the 95^th percentile. The acute dietary risk due to food does not exceed the level of concern (100%).

ii. Drinking water. Results from computer modeling indicate that sulfosate in ground water will not contribute significant residues in drinking water as a result of sulfosate use at the recommended maximum annual application rate (8.00 lbs. active ingredient/acre). The computer model uses conservative numbers, therefore it is unlikely that ground water concentrations would exceed the estimated concentration of 0.014 parts per billion (ppb), and sulfosate should not pose a threat to ground water.

The surface water estimates are based on an exposure modeling procedure called Generic Expected Environmental Concentration (GENEEC). The assumptions of two applications of 4.00 lbs. active ingredient/acre resulted in calculated estimated maximum concentrations of 58 ppb (acute, based on the highest 56-day value) and 10 ppb (chronic, average). GENEEC modeling procedures assumed that sulfosate was applied to a 10-hectare field that drained into a 1-hectare pond, 2-meters deep with no outlet.

As a conservative assumption, because sulfosate residues in ground water are expected to be insignificant compared to surface water, it has been assumed that 100% of drinking water consumed was derived from surface water in all drinking water exposure and risk calculations. To calculate the maximum acceptable acute and chronic exposures to sulfosate in drinking water, the dietary food exposure (acute or chronic) was subtracted from the appropriate (acute or chronic) RfD. Drinking water levels of concern (DWLOCs) were then calculated using the maximum acceptable acute or chronic exposure, default body weights (70 kg-adult, 10 kg-child), and drinking water consumption figures (2 liters-adult, 1 liter-child).

The maximum concentration of sulfosate in surface water is 58 ppb. The acute DWLOCs for sulfosate in surface water were all greater than 5,400 ppb. The estimated average concentration of sulfosate in surface water is 10 ppb which is much less than the calculated levels of concern (>1,300 ppb) in drinking water as a contribution to chronic aggregate exposure. Therefore, for current and proposed uses of sulfosate, Zeneca concludes with reasonable certainty that residues of sulfosate in drinking water would not result in unacceptable levels of aggregate human health risk.

2. Non-dietary exposure. Sulfosate is currently not registered for use on any residential non-food sites. Therefore, residential exposure to sulfosate residues will be through dietary exposure only.

D. Cumulative Effects

There is no information to indicate that toxic effects produced by sulfosate are cumulative with those of any other chemical compound.

E. Safety Determination

1. U.S. population—i. Acute risk. Since there are no residential uses for sulfosate, the acute aggregate exposure only includes food and water. Using the conservative assumptions of 100% of all crops treated and assuming all residues are at the tolerance level for all established and proposed tolerances, the aggregate exposure to sulfosate will utilize 12.3% of the acute RfD at the 95^th percentile for the U.S. population. The estimated peak concentrations of sulfosate in surface and ground water are less than DWLOCs for sulfosate in drinking water as a contribution to acute aggregate exposure. Residues of sulfosate in drinking water do not contribute significantly to the aggregate acute human health risk considering the present use and uses proposed in this action.

ii. Chronic risk. Using the conservative exposure assumptions described above, the aggregate exposure to sulfosate from food will utilize 17.6% of the chronic RfD for the U.S. population. The estimated average concentrations of sulfosate in surface and ground water are less than DWLOCs for sulfosate in drinking water as a contribution to chronic aggregate exposure. Residues of sulfosate in drinking water do not contribute significantly to the aggregate chronic human health risk considering the present uses and uses proposed in this action.

2. Infants and children. The data base on sulfosate relative to prenatal and postnatal toxicity is complete. Because the developmental and reproductive effects occurred in the presence of parental (systemic) toxicity, these data do not suggest an increased prenatal or postnatal sensitivity of children and infants to sulfosate exposure. Therefore, Zeneca concludes, upon the basis of reliable data, that a 100-fold uncertainty factor is adequate to protect the safety of infants and children and an additional safety factor is unwarranted.

i. Acute risk. Using the conservative exposure assumptions described above, the aggregate exposure to sulfosate from food will utilize 23.5% of the acute RfD at the 95^th percentile for the most highly exposed group, children (1-6 years). The estimated peak concentrations of sulfosate in surface and ground water are less than DWLOCs for sulfosate in drinking water as a contribution to acute aggregate exposure. Residues of sulfosate in drinking water do not contribute significantly to the aggregate acute human health risk considering the present uses and uses proposed in this action.

ii. Chronic risk. Using the conservative exposure assumptions described above, we conclude that the percent of the RfD that will be utilized by aggregate exposure to residues of sulfosate is 47.8% for children (1-6 years), the most highly exposed group. The estimated average concentrations of sulfosate in surface and ground water are less than DWLOCs for sulfosate in drinking water as a contribution to chronic aggregate exposure. Residues of sulfosate in drinking water do not contribute significantly to the aggregate chronic human health risk considering the present uses and uses proposed in this action.

F. International Tolerances

There are no Codex maximum residue levels established for sulfosate.