01-30369. Notice of Filing Pesticide Petitions to Establish a Tolerance for a Certain Pesticide Chemicals in or on Food

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

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

DATES:

Comments, identified by docket control number PF-970, must be received on or before January 7, 2002.

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-970 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:

By mail: Adam Heyward, Antimicrobials Division (7510C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone numbers: [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,” “Regulations 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 PF-970. 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-970 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-970. 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 pesticide petitions as follows proposing the establishment and/or amendment of regulations for residues of certain pesticide chemicals 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 these petitions contain 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 supports granting of the petitions. Additional data may be needed before EPA rules on the petitions.

List of Subjects

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

Dated: November 28, 2001.

Frank Sanders,

Director, Antimicrobials Division, Office of Pesticide Programs.

Summaries of Petitions

Petitioner summaries of the pesticide petitions are printed below as required by section 408(d)(3) of the FFDCA. The summaries of the petitions were prepared by the petitioners and represent the views of the petitioners. . The petition summaries 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.

I. Ecolab Inc.

PP 0F6193

EPA has received a pesticide petition (0F6193) from Ecolab Inc., 370 N. Wabasha Street, St. Paul MN 55102 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 to establish an exemption from the requirement of a tolerance for pelargonic acid nonanoic acid in or on the raw agricultural commodity, in processed commodities, and in or on meat and meat byproducts of cattle, sheep, hogs, goats, horses, and poultry, milk, and dairy products, eggs, seafood, and shellfish, and fruits and vegetables when such residues results from the use of pelargonic acid as a component of a food contact surface sanitizing solution for use in food handling establishments. The request is for unlimited clearance. 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. Analytical method. Because Ecolab Inc. is petitioning for an exemption from the requirement of a tolerance, an enforcement method for pelargonic acid is not needed.

2. Magnitude of residues. The residues which transfer from the sanitized dish or utensil to food are not of toxicological significance.

B. Toxicological Profile

1. Acute toxicity. From published literature values the acute oral LD₅₀ in rats was determined to be greater than 3.2 gram/kilogram (g/kg); the acute oral LD₅₀ in mice was 15 g/kg. The dermal LD₅₀ is greater than 5 g/kg. It is considered to be essentially non-toxic via the oral and dermal routes.

2. Genotoxicity. Nothing in the available literature indicates that the pelargonic acid is genotoxic.

3. Reproductive and developmental toxicity. Nothing in the available literature indicates the pelargonic acid is a developmental or reproductive toxin. No evidence of maternal or developmental toxicity was seen in a rat oral developmental toxicity screen with pelargonic acid at a dose of 1,500 milligrams/kilograms/day (mg/kg/day).

4. Subchronic toxicity. Nothing in the available literature indicates chronic exposure of pelargonic acid products any adverse toxicological effects unless it is ingested at an extremely high concentration. A 14-day oral toxicity test with rats revealed no adverse effects from pelargonic acid at any dose level, including the highest dietary concentration of 20,000 ppm, (equivalent to 1,834 mg/kg/day, a level exceeding the limit dose of 1,000 mg/kg/day). In another study, eight rats were exposed to a diet consisting of 4.19% pelargonic acid for 4 weeks equivalent to approximately 2,090 mg/kg/day). There was no effect on survival. At normal dietary intake levels in the human diet, no adverse effects would result.

5. Chronic toxicity. Chronic exposure would not produce any additional effect over what is noted in subchronic exposure, therefore, no additional concerns were warranted. Nothing in the literature indicates that pelargonic acid may be carcinogenic.

6. Endocrine disruption. A review of information from the Agency of Toxic Substances and Disease Registry indicates that potential endocrine effects from exposure to pelargonic acid have not been studied. The best of our knowledge, nothing in the available literature suggests that nonanoic acids as an endocrine disrupter or that it possesses intrinsic hormonal activity.

C. Aggregate Exposure

1. Dietary exposure—i. Acute. There are no acute toxicology concerns for pelargonic acid, an acute dietary risk assessment is not required.

ii. Chronic indirect. Using a worst-case scenario, the exposure resulting from the use of this material in a sanitizer would be 0.005 mg/kg/day for a 70 kg person (adult) and 0.007 mg/kg/day for a 28 kg person (child).

2. Food—Chronic direct. A typical adult ingest significant quantities of pelargonic acid via diet. When pelargonic acid is used as a compound of a food contact surface sanitizer, the residue that would be introduce into food will be insignificant. Based on this, there are no toxicological concerns resulting from exposures to residues of pelargonic acid from the use of sanitizing solutions.

3. Drinking water—i. Acute. Since there are no acute toxicological concerns for pelargonic acid, an acute drinking water risk assessment is not required.

ii. Chronic. There are no toxicological concerns about the exposure of low concentrations of pelargonic acid in the drinking water. Although it is possible that the trace amounts pelargonic acid resulting for its use as a sanitizer may ultimately get into drinking water, no adverse health effects would results.

4. Non-dietary exposure. The potential for significant additional non-occupational exposure to the general population (including children) is unlikely.

D. Cumulative Effects

Potentially small amounts of pelargonic acid exposure will be the result of non-food uses. The amount of pelargonic acid exposure resulting from direct exposure to sanitizing solutions will be minuscule. Since pelargonic acid in the diet poses no toxicological risk, the cumulative toxicity resulting form this additional exposure is negligible.

E. Safety Determination

1. U.S. population. Since there are no adverse toxicological effects resulting from normal dietary concentrations of pelagonic acid, there is no need to determine aggregate risks, or to conduct a safety determination. Pelargonic acid is generally recognized as safe and the incremental exposure due to its use as an inert in a food contact surface sanitizer is negligible.

2. Infants and children. As in adults, infants and children ingest pelargonic acid in their diet. Children are at no greater “risk” from exposure to pelargonic acid. Therefore, as with adults, a safety determination is not appropriate.

F. International Tolerances

No codex maximum residue levels have been established for pelargonic acid.

II. Ecolab Inc.

PP 0F6194

EPA has received a pesticide petition (0F6194) from Ecolab Inc., 370 N. Wabasha St., St. Paul MN 55102 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 to establish an exemption from the requirement of a tolerance for decanoic acid in or on the raw agricultural commodity, in processed commodities, and in or on meat and meat byproducts of cattle, sheep, hogs, goats, horses, and poultry, milk, and dairy products, eggs, seafood, and shellfish, and fruits and vegetables when such residues results from the use of decanoic acid as a component of a food contact surface sanitizing solution for use in food handling establishments. The request is for unlimited clearance. 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. Analytical method. Because Ecolab Inc. is petitioning for an exemption from the requirement of a tolerance, an enforcement method for decanoic acid is not needed.

2. Magnitude of residues. The residues which transfer from the sanitized dish or utensil to food are not of toxicological significance.

B. Toxicological Profile

1. Acute toxicity. From published literature values the acute oral LD₅₀ in rats ranged from 3.2 g/kg to greater than 10 g/kg. The dermal LD₅₀ in rats greater than 5 g/kg.

2. Genotoxicity. Nothing in the available literature indicates that the decanoic acid is genotoxic.

3. Reproductive and developmental toxicity. Nothing in the available literature indicates the decanoic acid is a developmental or reproductive toxin. It is generally recognized as safe and is normal constituent in the human diet.

4. Subchronic toxicity. Long term studies with decanoic acid have shown that this material is a relatively non-toxic. In on study, rats were fed decanoic acid in their diet at the level of 10% for 150 days. No adverse effects were observed at the conclusion of the study. In another study rats were administered decanoic acid at dietary levels 8% (corresponding to approximately 4 g/kg/day for 6 weeks. These animals exhibited reduced body weight gain and increased plasma triglyceride levels. Dogs fed approximately 4.4 g/kg/day of decanoic acid for 102 days showed no adverse effects.In another study, rats were fed 2.5 g/kg/day of decanoic acid (as the triglyceride) for 47 weeks. These animals showed no abnormalities in the cellular structure of the liver or intestine. Other animals ingesting 5 g/kg/day for 150 days did not develop abnormal tissues in the gastrointestinal tract. No other tissues were examined.

5. Chronic toxicity. Chronic exposure would not produce any additional effect over what is noted in subchronic exposure, therefore, no additional concerns were warranted. Nothing in the literature indicates that decanoic acid may be carcinogenic.

6. Endocrine disruption. A review of information from the Agency for Toxic Substances and Disease Registry indicates that potential endocrine effects from exposure to decanoic acid have not been studied. The best of our knowledge, nothing in the available literature suggests that decanoic acid acts as an endocrine disrupter or that is possesses intrinsic hormonal activity.

C. Aggregate Exposure

1. Dietary exposure— i. Acute. There are no acute toxicology concerns for decanoic acid, an acute dietary risk assessment is not required.

ii. Chronic indirect. Using a worst-case scenario, the exposure resulting from the use of this material in a sanitizer would be 0.0008 mg/kg/day for a 70 kg person (adult) and 0.0010 mg/kg/day for a 28 kg person (child).

2. Food—Chronic direct. A typical adult ingest significant quantities of decanoic acid via diet. When decanoic acid is used as a compound of a food contact surface sanitizer, the residue that would be introduce into food will be insignificant compared to the normal dietary intake. Based on this, there are no toxicological concerns resulting from exposures to residues of decanoic acid from the use of sanitizing solutions.

3. Drinking water— i. Acute. Since there are no acute toxicological concerns for decanoic acid, an acute drinking water risk assessment is not required.

ii. Chronic. There are no toxicological concerns about the exposure of low concentrations of decanoic acid in the drinking water. Although it is possible that the trace amounts decanoic acid resulting for its use as a sanitizer may ultimately get into drinking water, no adverse health effects would results.

4. Non-dietary exposure. The potential for significant additional non-occupational exposure to the general population (including children) is unlikely.

D. Cumulative Effects

Over 99% of the exposure to decanoic acid is expected to be via the diet. Potentially small amounts of decanoic acid exposure will be the result of non-food uses. The amount of decanoic acid exposure resulting from indirect exposure to sanitizing solutions will be minuscule. Since decanoic acid in the diet pose no toxicological risk, the cumulative toxicity resulting from the additional exposure is negligible.

E. Safety Determination

1. U.S. population. Since there are no adverse toxicological effects resulting from normal dietary concentrations of decanoic acid, there is no need to determine aggregate risks, or to conduct a safety determination. Decanoic acid is generally recognized as safe and the incremental exposure due to its use as an inert in a food contact surface sanitizer is negligible.

2. Infants and children. As in adults, infants and children ingest decanoic acid in their diet. Children are at no greater “risk” from exposure to decanoic acid. Therefore, as with adults, a safety determination is not appropriate.

F. International Tolerances

No codex maximum residue levels have been established for decanoic acid.