02-22235. 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 OPPT-2002-0167, must be received on or before October 4, 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 ID number OPPT-2002-0167 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:

By mail: Adam Heyward, Regulatory Management Branch II, Antimicrobials Division (7510C), 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,” “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 ID number OPPT-2002-0167. 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 ID number OPPT-2002-0167 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 ID number OPPT-2002-0167. 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 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 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

August 22, 2002.

Frank Sanders,

Director, Antimicrobials 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 Enviro Systems Inc. and represents the view of Enviro Systems Inc. EPA is publishing the petition summary verbatim without editing it 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.

Enviro Systems, Inc.

PP 1F6346

EPA has received a pesticide petition (1F6346) from Enviro Systems, Inc., 2055 Gateway Place, Suite 220, San Jose, CA 95110 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 P-chloro-m-xylenol (PCMX). PCMX an aqueous solution, is to be used on food processing equipment, utensils and other food-contact articles, beverage containers including milk bottles or containers and/or equipment. In addition, this solution may be used on food-contact surfaces in public eating places. 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. Analytical method. See EcoTru® Residue study, July 26, 2001.

2. Magnitude of residues. See EcoTru® Residue study, July 26, 2001. .41 mg. per square centimeter.

B. Toxicological Profile

1. Acute toxicity. Studies indicate at concentration of 0.2% of PCMX that EcoTru® is assigned a Toxicity Category IV on dermal, ocular, oral, and inhalation.

2. Genotoxicity. The salmonella mutagenesis study indicated no mutagenesis.

3. Reproductive and developmental toxicity. Studies submitted indicate at much greater concentration levels, no reproductive or developmental toxicity.

4. Subchronic toxicity. EcoTru® has only a 0.2% concentration of the active ingredient PCMX. In a study conducted by the North American Contact Dermatitis Group, incidents of skin sensitization among 1,752 dermatitis patients exposed to 1% chloroxylenol was only 13 reactors, less than 1%. The concentration of PCMX in the registered product EcoTru® is substantially less demonstrating that exposure would be minimal.

5. Chronic toxicity. EcoTru® has only a 0.2% concentration of the active ingredient PCMX. In a study conducted by the North American Contact Dermatitis Group, incidents of skin sensitization among 1,752 dermatitis patients exposed to 1% chloroxylenol was only 13 reactors, less than 1%. The concentration of PCMX in the registered product EcoTru® is substantially less demonstrating that exposure would be minimal.

6. Metabolite toxicology. The material is excreted as glucuronate or sulfate conjugate; these are not toxic. Since the pharmaco-kinetic studies have shown complete excretion of radioactive PCMX at 24 hours, there is little chance of accumulation in the body from either topical or oral administration. PCMX is rapidly metabolized with a half-life in dogs and rats of approximately 1 hour. It is completely excreted in the urine. These studies were in dosages far in excess of the concentration level of PCMX in EcoTru®.

7. Endocrine disruption. Acute toxicology studies showed no endocrine disruption. The compound chloroxylenol does not have estrogen or steroid-like activity.

C. Aggregate Exposure

1. Dietary exposure. PCMX, especially at the low concentration level as in EcoTru®, is not persistent nor mobile or volatile. The product is in liquid form directed at hard surfaces and because of the characteristics of the molecule, there is no evidence of dietary exposure. Past studies demonstrate no evidence of chronic and/or acute risk of aggregate exposure for the general population, infants or children.

i. Food. As indicated above, with the toxicology studies demonstrating no dermal, ocular, oral or inhalation irritation and the residue level is trivial, there should be insignificant aggregate exposure to food.

ii. Drinking water. The chemical has not been detected in ground or surface water nor would it likely pass through primary or secondary drinking water treatment into finished water. Registrant is unaware of any states conducting water-monitoring programs for this chemical.

2. Other exposures. Other non-pesticidal uses of PCMX have been in soaps, cosmetics, toiletries, and such pharmaceutical products as athlete's foot cream, acne cream, and surgical scrub products. These products have much higher concentration levels of PCMX than EcoTru. [See FDA docket 75N-O183, 1986].

D. Cumulative Effects

PCMX increases the permeability of cell membranes. The activity at the cell membrane leads to death of the microbe. The microgram amounts of PCMX in EcoTru® are trivial in comparison to the amounts used in the studies. Most of the studies used from 1-3% concentration of PCMX whereas EcoTru® has a 0.2% concentration of the chemical, thereby even reducing the likelihood of cumulative effects. There is no evidence of harmful effects of such low concentrations of PCMX over time.

E. Safety Determination

1. U.S. population. As set forth above, there is no evidence of harmful effects on the U.S. population. PCMX has been in products for decades in the United States amid as much larger concentrations than with EcoTru® without reports of harm.

2. Infants and children. The studies have indicated that no harmful effects on infants and children would occur with such low concentrations of PCMX, whether ingested or applied topically. See Safety Evaluation of PCMX, by Walter L Guess, Ph.D. in FDA docket No.75-0183 1986.