Pesticides; tolerances in food, animal feeds, and raw agricultural commodities: Copper ammonium complex,

[Federal Register: December 16, 1998 (Volume 63, Number 241)]

[Rules and Regulations]

[Page 69205-69208]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr16de98-13]

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300765; FRL 6048-5]

RIN 2070-AB78

Copper Ammonium Complex; Exemption from the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

SUMMARY: This rule establishes an exemption from the requirement of a tolerance for residues of copper ammonium complex in or on raw agricultural commodities when used in accordance with good agricultural practices as an active ingredient in pesticide formulations applied to growing crops. Chemical Specialties, Inc., submitted a petition to EPA under the Federal Food, Drug and Cosmetic Act, as amended by the Food Quality Protection Act of 1996 (Pub. L. 104-170), requesting this tolerance exemption.

DATES: This regulation is effective December 16, 1998. Objections and requests for hearings must be received by EPA on or before February 16, 1999. ADDRESSES: Written objections and hearing requests, identified by the

[[Page 69206]]

docket control number [OPP-300765], must be submitted to: Hearing Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St., SW., Washington, DC 20460. Fees accompanying objections and hearing requests shall be labeled ``Tolerance Petition Fees'' and forwarded to: EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees), P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any objections and hearing requests filedwith the Hearing Clerk identified by the docket control number, [OPP-300765], must also be submitted to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. In person, bring a copy of objections and hearing requests to Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA.

A copy of objections and hearing requests filedwith the Hearing Clerk may be submitted electronically by sending electronic mail (e- mail) to: opp-docket@epamail.epa.gov. Copies of electronic objections and hearing requests must be submitted as an ASCII file avoiding the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 5.1/6.1 or ASCII file format. All copies of electronic objections and hearing requests must be identified by the docket number [OPP-300765]. No Confidential Business Information (CBI) should be submitted through e-mail. Copies of electronic objections and hearing requests on this rule may be filedonline at many Federal Depository Libraries.

FOR FURTHER INFORMATION CONTACT: By mail: Cynthia Giles-Parker, Registration Division 7505C, Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. Office location, telephone number, and e-mail address: Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, 703-305-7740; e-mail: giles- parker.cynthia@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: In the Federal Register of June 12, 1998 (63 FR 3211) (FRL-5797-7), EPA issued a notice pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e) announcing the filing of a pesticide petition by Chemical Specialties, Inc., One Woodlawn Green, Suite 250, Charlotte, NC 28217. This notice included a summary of the petition prepared by the petitioner Chemical Specialties, Inc. 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 copper ammonium complex.

1. Risk Assessment and Statutory Findings

   Section 408(b)(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(b)(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.'' 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.

2. 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. The nature of the toxic effects caused by copper ammonium complex are discussed below:

   1. Acute toxicity. The acute oral LD‹INF›50‹/INF› for a 31.4% solution of copper ammonium complex is 2,055 milligrams/kilogram (mg/ kg). Accordingly, the acute oral toxicity of copper ammonium complex is relatively low.

   2. Genotoxicity, reproductive and developmental toxicity, subchronic toxicity and chronic toxicity. Copper is ubiquitous in nature, found naturally in most foods and essential for the well-being of humans: the copper ion is present in the adult human body at levels of 80-150 mg. In addition, humans possess a natural efficient homeostatic mechanism for regulating copper body levels over a wide range of dietary intake. The toxicity of the copper ion is well- characterized in the published literature. There is no evidence of any chronic effects induced by dietary ingestion of copper unless the intake is of such enormous magnitude that there is a disruption of the natural homeostatic mechanism for controlling body levels. Consequently, there is no reason to expect that long-term exposure to the copper ion in the diet is likely to lead to any subchronic, developmental, reproductive or chronic adverse effects. Finally, the toxicity profile of copper ammonium complex should not significantly differ from the numerous other copper compounds which are already exempted from the requirement of a tolerance.

3. Aggregate Exposures

   In examining aggregate exposure, FFDCA section 408 directs EPA to consider available information concerning exposures from the pesticide residue in food and all other non-occupational exposures, including drinking water from groundwater or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses).

   1. Dietary Exposure

      1. Food. Copper is naturally found in several types of food, such as fruits and vegetables, at levels ranging from 0.3-3.9 ppm. These levels are much higher than the levels of copper, if any, that may occur from the pesticidal application of copper ammonium complex. Copper levels in plants, subsequent to the application of copper ammonium complex or other copper salts, are minimized since high copper levels induce an imbalance with iron which causes plant dwarfing, stunted roots and decreased growth and yields. These effects appear before significant copper buildup takes place. The Agency has waived all residue chemistry studies for copper ammonium complex since copper is an essential trace element critical for the propogration of plants; copper is found in many foods; and it is impossible to distinguish copper residues resulting from naturally

         [[Page 69207]]

         occuring copper or copper ammonium complex.

      2. Drinking water exposure. The average copper concentration in drinking water is 0.13 ppm. This concentration is substantially below the drinking water standard of 1 ppm.

   2. Other Non-Occupational Exposure

      Inhalation exposure. Air concentrations of copper are relatively low. A study based on several thousand samples assembled by EPA's Environmental Monitoring Systems Laboratory showed copper levels ranging from 0.003-7.32 ‹greek-m›g/m‹SUP›3‹/SUP›. Other studies indicate that air levels of copper are much lower.

4. Cumulative Effects

   Copper has no significant toxicity to humans. Accordingly, the Agency believes that there is no reason to expect any cumulative effects from the use of copper ammonium complex on food crops.

5. Determination of Safety for U.S. Population, Infants and Children

   Several copper compounds, such as the copper salts of fatty acids and copper sulfate, are currently approved for use on food crops. Since copper ammonium complex is a substitute for these copper compounds, and under use-conditions, releases equivalent amounts of copper, no increases in dietary exposure will occur from the use of copper ammonium complex on food crops. Moreover, copper is an essential trace element for which the National Academy of Sciences has issued a recommended daily allowance of 0.5-1.0 mg/day for infants, 1.0-2.0 mg/ day for small children and 2.0-3.0 mg/day for adolescents and adults. Furthermore, since copper has no significant toxicity and EPA has therefore not used a margin of safety approach to assess any risk posed by copper, the requirement pertaining to an additional margin of safety for infants and children is not applicable to EPA's safety determination for this tolerance exemption. Because use of copper ammonium complex is unlikely to pose a dietary risk under reasonably foreseeable circumstances, EPA concludes that there is a reasonable certainty of no harm from aggregate exposure to copper ammonium complex residues. Accordingly, EPA finds that exempting copper ammonium complex from the requirement of a tolerance will be safe.

6. Other Considerations

   1. Endocrine Disruptors

      The Agency has no information to suggest that copper will adversely affect the immune or endocrine systems. The Agency is not requiring information on the endocrine effects of copper at this time; Congress has allowed 3 years after August 3, 1996, for the Agency to implement a screening program with respect to endocrine effects.

   2. Analytical Method(s)

      The Agency is establishing an exemption from the requirement of a tolerance without any numeric limitation; therefore, the Agency has concluded that an analytical method is not required for enforcement purposes for copper ammonium complex.

   3. Existing Tolerances

      There are no existing tolerances for copper ammonium complex.

   4. International Tolerances

      No maximum residue level has been established for copper ammonium complex by the Codex Alimentarius Commission.

7. Objections and Hearing Requests

   The new FFDCA section 408(g) provides essentially the same process for persons to ``object'' to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408(d)and as was provided in the old section 408 and in section 409. However, the period for filing objections is 60 days, rather than 30 days. EPA currently has procedural regulations which governs the submission of objections and hearing requests. These regulations will require some modification to reflect the new law. However, until those modifications can be made, EPA will continue to use those procedural regulations with appropriate adjustments to reflect the new law.

   Any person may, by February 16, 1999, file written objections to any aspect of this regulation and may also request a hearing on those objections. Objections and hearing requests must be filedwith the Hearing Clerk, at the address given under the ``ADDRESSES'' section (40 CFR 178.20). A copy of the objections and/or hearing requests filed with the hearing clerk should be submitted to the OPP docket for this rulemaking. The objections submitted must specify the provisions of the regulation deemed objectionable and the grounds for the objections (40 CFR 178.25). Each objection must be accompanied by the fee prescribed by 40 CFR 180.33(i) or a request for a fee waiver, as noted in 40 CFR 180.33(m). If a hearing is requested, the objections must include a statement of the factual issues(s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector (40 CFR 178.27). A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32). Information submitted in connection with an objection or hearing request may be claimed confidential 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. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice.

8. Public Record and Electronic Submissions

   EPA has established a record for this rulemaking under docket control number [OPP-300765]. A public version of this record, including printed, paper versions of electronic comments, which does not include any information claimed as CBI, is available for inspection from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The public record is located in Rm. 119 of the Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202.

   The official record for this rulemaking, as well as the public version, as described above, is kept in paper form. Accordingly, in the event there are objections and hearing request, EPA will transfer any copies of objections and hearing requests received electronically into printed, paper form as they are received and will place the paper copies in the official rulemaking record. The official rulemaking record is the paper record maintained at the Virginia address in ADDRESSES at the beginning of this document.

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9. Regulatory Assessment Requirements

   1. Certain Acts and Executive Orders

      This final rule establishes an exemption from the tolerance requirement under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub.L. 104-4). Nor does it require special considerations as required by Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629), February 16, 1994), or require OMB review in accordance with Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). In additions, since tolerance exemptions that are established on the basis of a petition under section 408(d) of the FFDCA, such as the exemption in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. Nevertheless, the Agency previously assessed whether establishing tolerances, exemptions from tolerances, raising tolerance levels or expanding exemptions might adversely impact small entities and concluded, as a generic matter, that there is no adverse economic impact. The factual basis for the Agency's generic certification for tolerance actions published on May 4, 1981 (46 FR 24950), and was provided to the Chief Counsel for Advocacy of the Small Business Administration.

   2. Executive Order 12875

      Under Executive Order 12875, entitled Enhancing the Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may not issue a regulation that is not required by statute and that creates a mandate upon a State, local, or tribal government, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by those governments. If the mandate is unfunded, EPA must provide to OMB a description of the extent of EPA's prior consultation with representatives of affected State, local, and tribal governments, the nature of their concerns, copies of any written communications from the governments, and a statement supporting the need to issue the regulation. In addition, Executive Order 12875 requires EPA to develop an effective process permitting elected officials and other representatives of State, local, and tribal governments ``to provide meaningful and timely input in the development of regulatory proposals containing significant unfunded mandates.''

      Today's rule does not create an unfunded Federal mandate on State, local, or tribal governments. The rule does not impose any enforceable duties on these entities. Accordingly, the requirements of section 1(a) of Executive Order 12875 do not apply to this rule.

   3. Executive Order 13084

      Under Executive Order 13084, entitled Consultation and Coordination with Indian Tribal Governments (63 FR 27655, May 19,1998), EPA may not issue a regulation that is not required by statute, that significantly or uniquely affects the communities of Indian tribal governments, and that imposes substantial direct compliance costs on those communities, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by the tribal governments. If the mandate is unfunded, EPA must provide to OMB, in a separately identified section of the preamble to the rule, a description of the extent of EPA's prior consultation with representatives of affected tribal governments, a summary of the nature of their concerns, and a statement supporting the need to issue the regulation. In addition, Executive Order 13084 requires EPA to develop an effective process permitting elected officials and other representatives of Indian tribal governments ``to provide meaningful and timely input in the development of regulatory policies on matters that significantly or uniquely affect their communities.''

      Today's rule does not significantly or uniquely affect the communities of Indian tribal governments. This action does not involve or impose any requirements that affect Indian tribes. Accordingly, the requirements of section 3(b) of Executive Order 13084 do not apply to this rule.

10. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This is not a ``major rule'' as defined by 5 U.S.C. 804(2).

    List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, Agricultural commodities, pesticides and pests, Reporting and recordkeeping requirements.

    Dated: December 1, 1998.

    James Jones, Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

    PART 180-- [AMENDED]

    1. The authority citation for part 180 continues to read as follows:

       Sec. 180.1001 [Amended]

       Authority: 21 U.S.C. 346a and 371.

    2. In Sec. 180.1001, by adding ``copper ammonium complex'' immediately after ``copper acetate,'' in paragraph (b)(1).

       [FR Doc. 98-33117Filed12-15-98; 8:45 am]

       BILLING CODE 6560-50-F