Pesticides; tolerances in food, animal feeds, and raw agricultural commodities: Sulfosate,

[Federal Register: April 28, 1999 (Volume 64, Number 81)]

[Rules and Regulations]

[Page 22802-22806]

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

[DOCID:fr28ap99-9]

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300849; FRL-6076-1]

RIN 2070-AB78

Sulfosate; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a tolerances for residues of sulfosate in or on wheat and pome fruit and increases tolerances in milk. In addition, for cattle, goat, hog, sheep, and horse commodities, this regulation establishes tolerances in liver and meat-by products except liver and increases the tolerance in meat. Zeneca Ag Products requested this tolerance under the Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality Protection Act of 1996.

DATES: This regulation is effective April 28, 1999. Objections and requests for hearings must be received by EPA on or before June 28, 1999. ADDRESSES: Written objections and hearing requests, identified by the docket control number, [OPP-300849], 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-300849], 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@epa.gov. Copies of objections and hearing requests must be submitted as an ASCII file avoiding the use of special characters and any form of encryption. Copies of objections and hearing requests will also be accepted on disks in WordPerfect 5.1/6.1 file format or ASCII file format. All copies of objections and hearing requests in electronic form must be identified by the docket control number [OPP-300849]. No Confidential Business Information (CBI) should be submitted through e-mail. Electronic copies of objections and hearing requests on this rule may be filedonline at many Federal Depository Libraries.

FOR FURTHER INFORMATION CONTACT: By mail: Jim Tompkins, 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: Rm. 239, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, 703-305-5697, tompkins.jim@epa.gov.

SUPPLEMENTARY INFORMATION: In the Federal Register of January 20, 1999 (64 FR 3099) (FRL-6053-5), EPA issued a notice pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104- 170 announcing the filing of a pesticide petition (PP 5F4554) for tolerance by Zeneca Ag. Products, 1800 Concord Pike, P. O. Box 15458, Wilmington, DE 19850-5458. This notice included a summary of the petition prepared by Zeneca Ag Products, the registrant. There were no comments received in response to the notice of filing.

The petition requested that 40 CFR 180.489 be amended by establishing a tolerance for residues of the herbicide sulfosate, in or on wheat bran at 2.5 parts per million (ppm) (of which no more than 0.75 ppm is trimethylsulfonium (TMS)), wheat grain at 0.75 ppm (of which no more than 0.25 ppm is TMS), wheat forage at 35 ppm (of which no more than 30 ppm is TMS), wheat hay at 85 ppm (of which no more than 80 ppm is TMS), wheat shorts at 1.5 ppm (of which no more than 0.5 ppm is TMS), wheat straw at 1.0 ppm (of which no more than 0.5 ppm is TMS), the pome fruit group at 0.05 ppm; in cattle, goat, hog, sheep, and horse liver at 0.5 ppm, in cattle, goat, hog, sheep, and horse meat by- products, except liver at 2.5 ppm; to increase the tolerance in cattle, goat, hog, sheep, and horse meat from 0.2 to 0.4 ppm and in milk from 0.2 to 0.5 ppm.

In the Federal Register of September 11, 1998 (63 FR 48597) (FRL- 6026-6), EPA issued a final rule for establishment of tolerances for sulfosate on corn, soybean eggs, milk, cattle, goat, hog, sheep, and horse commodities. Sulfosate residues, at the above levels, resulting from consumption of wheat, pome fruit, meat, milk, poultry, and eggs were included in the dietary and risk assessments conducted to establish these tolerances.

1. Background and Statutory Findings

   Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish 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. For further discussion of the regulatory requirements of section 408 and a complete description of the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

2. Aggregate Risk Assessment and Determination of Safety

   Consistent with section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of sulfosate and to make a determination on aggregate exposure, consistent with section 408(b)(2), for a tolerance for residues of sulfosate on wheat bran at 2.5 parts per million (ppm) (of which no more than 0.75 ppm is trimethylsulfonium (TMS)), wheat grain at 0.75 ppm (of which no more than 0.25 ppm is TMS), wheat forage at 35 ppm (of which no more than 30 ppm is TMS), wheat hay at 85 ppm (of which no more than 80 ppm is TMS), wheat shorts at 1.5 ppm (of which no more than 0.5 ppm is TMS), wheat straw at

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   1.0 ppm (of which no more than 0.5 ppm is TMS), the pome fruit group at 0.05 ppm; in cattle, goat, hog, sheep, and horse liver at 0.5 ppm, in cattle, goat, hog, sheep, and horse meat by-products, except liver at 2.5 ppm; to increase the tolerance in cattle, goat, hog, sheep, and horse meat from 0.2 to 0.4 ppm and in milk from 0.2 to 0.5 ppm. EPA's assessment of the dietary exposures and risks associated with establishing the tolerance follows.

   1. Toxicological Profile

      EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies 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 sulfosate are discussed in Unit II. A. of the Federal Register notice of September 11, 1998 (63 FR 48597). Please note that this unit included a typographical error. In the discussion of the feeding carcinogenicity study in mice, ``79'' should have been ``7.9'' in the following phrase: ``In addition, there was increased incidence of white matter degeneration in the lumbar region of the spinal cord (males only) (2, 3, 4, 4, 79% response, controls to high dose)...''

   2. Toxicological Endpoints

      The toxicological endpoints for sulfosate are discussed in Unit II. B. of the Federal Register notice of September 11, 1998 (63 FR 48597).

   3. Exposures and Risks

      The exposures and risks due to consumption of sulfosate, including residues in wheat and pome fruit, are discussed in Unit II. C. of the Federal Register notice of September 11, 1998 (63 FR 48597).

   4. Aggregate Risks and Determination of Safety for U.S. Population

      The aggregate risks and determination of safety for the U.S. population resulting from use of sulfosate are discussed in Unit II. D. of the Federal Register notice of September 11, 1998 (63 FR 48597).

   5. Aggregate Risks and Determination of Safety for Infants and Children

      The aggregate risks and determination of safety for infants and children resulting from use of sulfosate are discussed in Unit II. E. of the Federal Register notice of September 11, 1998 (63 FR 48597).

3. Other Considerations

   1. Metabolism In Plants and Animals

      The nature of the residues in plants and animals is understood. EPA has determined that the tolerance expression for sulfosate must include both of the parent ions.

   2. Analytical Enforcement Methodology

      Analytical enforcement methodology for sulfosate is discussed in Unit III. B. of the Federal Register notice of September 11, 1998 (63 FR 48597).

   3. Magnitude of Residues

      The crop field trial data are adequate to support these tolerances.

   4. International Residue Limits

      There are no Codex, Canadian or Mexican tolerances or maximum residue limits for residues of sulfosate in the subject crops. Therefore, a compatibility issue is not relevant to the proposed tolerances.

   5. Rotational Crop Restrictions

      EPA has previously reviewed two confined rotational crop studies for sulfosate and concluded that rotational crop restrictions were not required.

4. Conclusion

   Therefore, the tolerances are established for residues of sulfosate on wheat bran at 2.5 parts per million (ppm) (of which no more than 0.75 ppm is trimethylsulfonium (TMS)), wheat grain at 0.75 ppm (of which no more than 0.25 ppm is TMS), wheat forage at 35 ppm (of which no more than 30 ppm is TMS), wheat hay at 85 ppm (of which no more than 80 ppm is TMS), wheat shorts at 1.5 ppm (of which no more than 0.5 ppm is TMS), wheat straw at 1.0 ppm (of which no more than 0.5 ppm is TMS), the pome fruit group at 0.05 ppm; in cattle, goat, hog, sheep, and horse liver at 0.5 ppm, in cattle, goat, hog, sheep, and horse meat by- products, except liver at 2.5 ppm. Further, the tolerances are increased tolerance in cattle, goat, hog, sheep, and horse meat from 0.2 to 0.4 ppm and in milk from 0.2 to 0.5 ppm.

5. Objections and Hearing Requests

   The new FFDCA section 408(g) provides essentially the same process for persons to ``object'' to a tolerance regulation 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 govern 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 June 28, 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 regulation. 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). EPA is authorized to waive any fee requirement ``when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.'' For additional information regarding tolerance objection fee waivers, contact James Tompkins, 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: Rm. 239, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, (703) 305-5697, tompkins.jim@epa.gov. Requests for waiver of tolerance objection fees should be sent to James Hollins, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.

   If a hearing is requested, the objections must include a statement of the factual issues on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the requestor (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 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 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

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   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.

6. Public Record and Electronic Submissions

   EPA has established a record for this regulation under docket control number [OPP-300849] (including any comments and data submitted electronically). 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 Room 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.

   Objections and hearing requests may be sent by e-mail directly to EPA at:

   opp-docket@epa.gov.

   E-mailed objections and hearing requests must be submitted as an ASCII file avoiding the use of special characters and any form of encryption.

   The official record for this regulation, as well as the public version, as described in this unit will be kept in paper form. Accordingly, 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 record which will also include all comments submitted directly in writing. The official record is the paper record maintained at the Virginia address in ``ADDRESSES'' at the beginning of this document.

7. Regulatory Assessment Requirements

   1. Certain Acts and Executive Orders

      This final rule establishes a tolerance under section 408(d) of the FFDCA 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 any prior consultation as specficed by Executive Order 12875, entitled Enhancing the Intergovernmental Partnership (58 FR 58093, October 28, 1993), or 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 addition, since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the

      [tolerance/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 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.

8. 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 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

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   the Comptroller General of the United States prior to publication of the rule in the Federal Register. This rule 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: April 14, 1999.

   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:

      Authority: 21 U.S.C. 321q, 346a, and 371.

   2. Section 180.489 is revised to read as follows:

      Sec. 180.489 Sulfosate (Sulfonium, trimethyl-salt with N- (phosphonomethyl)glycine (1:1)); tolerances for residues.

      (a) General. Tolerances are established for residues of the herbicide sulfosate (sulfonium, trimethyl-salt with N- (phosphonomethyl)glycine (1:1)) in or on the following raw and processed agricultural commodities:

      Commodity

      Parts per million

      Almond, hulls (of which no more than 0.30 ppm is

      1.00 trimethylsulfonium (TMS))....................................... Aspirated grain fractions (of which no more than 60 ppm is TMS)..

      210.00 Bananas (imported only) \1\......................................

      0.05 Cattle, fat......................................................

      0.10 Cattle, liver....................................................

      0.5 Cattle, mbyp except liver........................................

      2.5 Cattle, meat.....................................................

      0.4 Citrus fruit group...............................................

      0.05 Corn, field, forage..............................................

      0.10 Corn, field and pop, grain (of which no more than 0.10 ppm is

      0.20 TMS)............................................................ Corn, field and pop, stover (of which no more than 0.20 ppm is

      0.30 TMS)............................................................ Eggs.............................................................

      0.02 Goats, fat.......................................................

      0.10 Goats, liver.....................................................

      0.5 Goats, mbyp, except liver........................................

      2.5 Goats, meat......................................................

      0.4 Grape............................................................

      0.10 Hogs, fat........................................................

      0.10 Hogs, liver......................................................

      0.5 Hogs, mbyp except liver..........................................

      2.5 Hogs, meat.......................................................

      0.4 Horses, fat......................................................

      0.10 Horses, liver....................................................

      0.5 Horses, mbyp except liver........................................

      2.5 Horses, meat.....................................................

      0.4 Milk.............................................................

      0.5 Pome fruit group.................................................

      0.05 Poultry, fat.....................................................

      0.05 Poultry, liver...................................................

      0.05 Poultry, mbyp (except liver).....................................

      0.10 Poultry, meat....................................................

      0.05 Prune (of which no more than 0.05 ppm is TMS)....................

      0.20 Raisin (of which no more than 0.05 ppm is TMS)...................

      0.20 Sheep, fat.......................................................

      0.10 Sheep, liver.....................................................

      0.5 Sheep, mbyp except liver.........................................

      2.5 Sheep, meat......................................................

      0.5 Soybean, forage (of which no more than 1 ppm is TMS).............

      2.0 Soybean, hay (of which no more than 2 ppm is TMS)................

      5.0 Soybean, hulls (of which no more than 2 ppm is TMS)..............

      7.0 Soybean, seed (of which no more than 1 ppm is TMS)...............

      3.0 Stone fruit group................................................

      0.05 Tree nut group...................................................

      0.05 Wheat bran (of which no more than 0.75 ppm is TMS................

      2.5 Wheat grain (of which no more than 0.25 ppm is TMS)..............

      0.75 Wheat forage (of which no more than 30 ppm is TMS................

      35 Wheat hay (of which no more than 80 ppm is TMS...................

      85 Wheat shorts (of which no more than 0.5 ppm is TMS)..............

      1.5 Wheat straw (of which no more than 0.5 ppm is TMS)...............

      1.0

      \1\ There are no U.S. registrations as of the date of publication of the tolerance in the Federal Register

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      (b) Section 18 emergency exemptions. [Reserved]

      (c) Tolerances with regional registrations. [Reserved]

      (d) Indirect or inadvertent residues. [Reserved]

      [FR Doc. 99-10520Filed4-27-99; 8:45 am]

      BILLING CODE 6560-50-F