01-27469. 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-must be received on or before December 3, 2001.

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-1046 the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:

By mail: Linda Hollis, Biopesticides and Pollution Prevention Division, Registration Division (7505W), 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 homepage at http://www.epa.gov/​. To access this document, on the homepage 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 PF-1046. 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-1046 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-000. 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: October 17, 2001.

Janet L. Anderson,

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. 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.

BioSafe Systems

PP 8F4996

EPA has received a pesticide petition 8F4996 from Biosafe Systems, 80 Commerce Street, Glastonbury, CT 06033], 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 amendment/expansion of an existing tolerance exemption for the biochemical pesticide hydrogen peroxide in or on all postharvest agricultural food commodities at the rate of < 1% hydrogen peroxide per application.

Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended, Biosafe Systems has submitted the following summary of information, data, and arguments in support of their pesticide petition. This summary was prepared by [Biosafe Systems] and EPA has not fully evaluated the merits of the pesticide petition. The summary may have been edited by EPA if the terminology used was unclear, the summary contained extraneous material, or the summary unintentionally made the reader conclude that the findings reflected EPA's position and not the position of the petitioner.

A. Product name and Proposed Use Practices

Hydrogen peroxide is for use to control plant pathogenic diseases on plants, food commodities, greenhouse surfaces and other agricultural use sites. BioSafe Systems maintains 2 registrations for 27.00% hydrogen peroxide end-use products, ZeroTol (EPA Reg. No. 70299-1) and Oxidate (EPA Reg. No. 70299-2), for these uses.

B. Product Identity/Chemistry

1. Identity of the pesticide and corresponding residues. Hydrogen peroxide reacts on contact with a surface on which it is applied, and rapidly degrades to oxygen and water, neither of which is of toxicological concern.

2. Analytical method. An analytical method for the detection of residues of hydrogen peroxide is not applicable. Hydrogen peroxide is used in low concentrations and rapidly degrades into water and oxygen.

C. Mammalian Toxicological Profile

Hydrogen peroxide at a concentration of 27% has a pH of 1.05, at which concentration the Agency assumes a toxicity category I for skin and eye irritation. BioSafe Systems has submitted toxicology information from open literature for aqueous solutions containing 6% and 50% hydrogen peroxide. The concentrate (27% hydrogen peroxide) will be diluted with water at the rate of 1:50 or 1:100 or 1:300 and thus, the concentration of hydrogen peroxide in the product at the time of application will range from 0.09% to 0.54%.

The information from open literature demonstrated that solutions containing 6% hydrogen peroxide have an acute oral LD₅₀ ≥5,000 mg/kg in rats (toxicity category III), an acute dermal LD₅₀ ≥10,000 mg/kg in rabbits (toxicity category IV), and an inhalation LC₅₀ of 4 milligrams per liter (mg/l) (toxicity category IV). The 6% hydrogen peroxide solutions are mild irritants to rabbit skin and cause sever irreversible corneal injury in half of the exposed rabbits (toxicity category I). Toxicology information from open literature demonstrated that solutions that contained 50% hydrogen peroxide have an acute oral LD₅₀ ≥500 mg/kg in rats (toxicity category II) and an acute dermal LD₅₀ ≥1,000 mg/kg in rabbits (toxicity category II). No deaths resulted after an 8-hour exposure of rats to saturated vapors of 90% hydrogen peroxide, LC₅₀ is 4 mg/l (2,000 ppm). Solutions that contain 50% hydrogen peroxide are also extremely irritating (corrosive) to rabbit eyes (toxicity category I).

EPA has concluded that for food use at an application rate of ≤1% hydrogen peroxide, no apparent acute toxicity and subchronic toxicity end-points exist to suggest a significant toxicity. An RfD (chronic toxicity) for hydrogen peroxide has not been estimated because of its short half-life in the environment and lack of any residues of toxicological concern. For similar reasons, an additional safety factor was not judged necessary to protect the safety of infants and children. Additionally, hydrogen peroxide is listed by the Food and Drug Administration as Generally Recognized as Safe (GRAS).

Additionally, hydrogen peroxide is used to treat food at a maximum level of 0.05% in milk used in cheese-making, 0.04% in whey, 0.15% in starch and corn syrup, and 1.25% in emulsifiers containing fatty acid esters as bleaching agents (21 CFR Part 184.1366). As a GRAS su stance, hydrogen peroxide may be used in washing or to assist in the lye peeling of fruits and vegetables (21 CFR 173.315).

D. Aggregate Exposure

1. Dietary exposure—i. Food. For the proposed uses, the concentrate of hydrogen peroxide will be diluted with water ate the rate of 1:50, 1:100 or 1:300 corresponding to a low concentration of hydrogen peroxide in the product at the time of application (0.09% - 0.54%). The solution, having a low concentration of hydrogen peroxide, reacts on contact with the surface on which it is sprayed, and degrades rapidly to oxygen and water. Therefore residues in or on treated food commodities (growing and postharvest crops) are expected to be negligible. Additional sources of the GRAS substance hydrogen peroxide in concentrations range from 0.04% to 1.25% in various foods as cited above (21 CFR Part 184.1366).

ii. Drinking water. At the proposed application rates, the use of hydrogen peroxide to treat food commodities will result in minimal transfer of residues to potential drinking water sources. This is due to the low application rate and the rapid chemical degradation of hydrogen peroxide into oxygen and water, neither of which is of toxicological concern. The EPA Office of Water has stated that it has seen no new data that contradict the assessment previously given which is that low concentrations of hydrogen peroxide do not typically persist in drinking water at levels that pose a health risk.

2. Non-dietary exposure. There will be minimal amounts of non-dietary exposure to hydrogen peroxide, primarily through infrequent or short use of topical hydrogen peroxide products for treating minor skin injuries, and through use of oral mouthwashes. Exposure is expected to be minimal, and when used hydrogen peroxide rapidly degradates into oxygen and water, neither of which is of toxicological concern.

E. Cumulative Exposure

Because of the low use rates of hydrogen peroxide, its low toxicity and rapid degradation, EPA does not believe that there is any concern regarding the potential for cumulative effects of hydrogen peroxide with other substances due to a common mechanism of action. Because hydrogen peroxide is not known to have a common toxic metabolite with other substances, EPA has not assumed that hydrogen peroxide has a common mechanism of toxicity with other substances.

F. Safety Determination to the General U.S. Population, and Infants and Children

Because hydrogen peroxide is of low toxicity, the proposed uses employ low concentrations of hydrogen peroxide, and hydrogen peroxide degrades rapidly following application, EPA concludes that this exemption from the requirement of a tolerance in or on all food commodities for hydrogen peroxide, when applied at ≤1%, will not pose a dietary risk under reasonably foreseeable circumstances. Further, the EPA Office of Water has stated that it has seen no new data that contradict the assessment previously given which is that low concentrations of hydrogen peroxide do not typically persist in drinking water at levels that pose a health risk. Accordingly EPA concluded that there is a reasonable certainty of no harm to consumers, including infants and children, from aggregate exposure to hydrogen peroxide.

G. Effects on the Immune and Endocrine Systems

There is no evidence to suggest that hydrogen peroxide in the proposed concentrations will adversely affect the endocrine system.

H. Existing Tolerances

An exemption from the requirement of a tolerance (40 CFR Part 180.1197) is established for residues of hydrogen peroxide in or on all food commodities at the rate of ≤ 1% hydrogen peroxide per application on growing crops and postharvest potatoes when applied as an algaecide, fungicide and bactericide.

I. International Tolerances

There is no Codex Alimentarium Commission Maximum Residue Level (MRL) for hydrogen peroxide.