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Federal Register: October 22, 2001 (Volume 66, Number 204)Rules and RegulationsPage 53342-53346From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DOCID:fr22oc01-7

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

OPP-301056; FRL-6745-6RIN 2070-AB78

Pseudomonas Chlororaphis Strain 63-28; Exemption from the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes an exemption from the requirement of a tolerance for residues of the Pseudomonas chlororaphis Strain 63- 28 in or on all food commodities. Agrium US, Inc. submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of Pseudomonas chlororaphis Strain 63-28.

DATES: This regulation is effective October 22, 2001. Objections and requests for hearings, identified by docket control number OPP-301056, must be received by EPA, on or before December 21, 2001.

ADDRESSES: Written objections and hearing requests may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit IX. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, your objections and hearing requests must identify docket control number OPP-301056 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Anne Ball, c/o Product Manager (PM) 90, Biopesticides and Pollution Prevention Division (7511C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 308-8717; and e-mail address: Ball.Anne@epa.gov.

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:

Examples of Categories

NAICS codes

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.

[Page 53343]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/. A frequently updated electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/ nara/cfr/cfrhtml_180/Title_40/40cfr180_00.html, a beta site currently under development.

2. In person. The Agency has established an official record for this action under docket control number OPP-301056. The official record consists of the documents specifically referenced in this action, 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 Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

In the Federal Register of November 20, 1998 (63 FR 64478) (FRL- 6042-4), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 346a(d), as amended by the FQPA (Public Law 104-170) announcing the filing of a pesticide tolerance petition by Agrium US, Inc., 4582 S. Ulster St., Suite 1400, Denver, CO 80237. This notice included a summary of the petition prepared by the petitioner Agrium US, Inc. On October 13, 1999 all of Agrium's data were transferred to Eco Soil Systems, Inc. 10740 Thornmint Rd., San Diego, CA 92127 and Eco Soil Systems, Inc. is still interested in seeking this exemption. There were no comments received in response to the notice of filing.

The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of Pseudomonas chlororaphis Strain 63-28.

III. Risk Assessment

New section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is ``safe.'' Section 408(c)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.'' This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to ``ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue....'' Additionally, section 408(b)(2)(D) requires that the Agency consider ``available information'' concerning the cumulative effects of a particular pesticide's residues and ``other substances that have a common mechanism of toxicity.''

EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, EPA determines the toxicity of pesticides. Second, EPA examines exposure to the pesticide through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings.

IV. Toxicological Profile

Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness, and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

Acute toxicity studies indicate that AtEze, the end-use product containing P. chlororaphis Strain 63-28 is a Toxicity Category IV substance. The acute oral toxicity of P. chlororaphis Strain 63-28 in rats is greater than 5,000 milligrams/kilogram of body weight or Toxicity Category IV. The LD50for dermal toxicity of P. chlororaphis Strain 63-28 is considered to be > 2g/kg body weight or Toxicity Category IV. In an eye irritation study, six New Zealand White rabbits were treated with the product and all except one showed no ocular irritation with observations continuing for seven days after dosing. (Toxicity Category IV). In a toxicity/pathogenicity study, the product containing P. chlororaphis Strain 63-28 was tested following acute intravenous challenge in male and female rats. Intravenous administration of the viable test substance (TS) and killed test substance (KTS) was followed by measuring levels of viable microbes in sampled tissues and observing for signs of toxicity or pathogenicity. A sampling of organs for presence of P. chlororaphis showed that cells were present in lungs, spleen, kidneys, and livers of male and female rats, and in the blood, mesenteric lymph nodes and caecum of male rats on day 0 (i.e. the day of treatment with TS). In subsequent sampling, one female rat was found to harbor some viable P. chlororaphis in the kidney on day three. All other samples from all animals were negative (i.e., below the detection limit). This lack of detection of the test substance in TS treated rats after day 3 indicates a clearance of the organism from the animals to 01-26533Filed10-19-01] BILLING CODE 6560-50-S

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