Sulfosate; Pesticide Tolerance

In the Federal Register of April 8, 1999 (64 FR 17171) (FRL-6071-2), 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) (Public Law 104-170) announcing the filing of a pesticide petition (PP) for tolerance by Zeneca Ag Products, PO Box 751, Wilmington, DE 19897. 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 tolerances for residues of the herbicide sulfosate, in or on cattle, goat, hog, sheep, and horse kidney at 3.5 parts per million (ppm); in cattle, goat, hog, sheep, and horse mbyp, except liver and kidney, at 1.0 ppm (due to an error, this tolerance was listed as 2.5 ppm in the notice of filing, at 64 FR 17171); and to increase the tolerance in cattle, goat, hog, sheep, and horse fat to 0.2 ppm; in cattle, goat, hog, sheep, and horse meat to 0.6 ppm; in cattle, goat, hog, sheep, and horse liver to 0.75 ppm; in milk to 1.1 ppm;; in or on soybean seed to 21 ppm (of which no more than 13 ppm is TMS); in soybean hulls to 45 ppm (of which no more than 25 ppm is TMS); and in aspirated grain fractions to 1,300 ppm (of which no more than 720 ppm is TMS). Due to differences in methods for estimating residues in food commodities and EPA policy in expressing tolerances for residues in mbyp, liver, and kidney, EPA determined that modifications were needed to the following proposed tolerances: kidney of cattle, hogs, sheep, goats, and horses should be increased from 3.5 ppm to 6.0 ppm; meat by- products should be expressed in terms of ``mbyp (except kidney)'' at 1.5 ppm (instead of the requested 1.0 ppm); meat of cattle, hogs, sheep, goats, and horses should be increased from 0.6 ppm to 1.0 ppm; fat of cattle, hogs, sheep, goats, and horses should be increased from 0.2 ppm to 0.5 ppm; and milk should be increased from 1.1 ppm to 1.5 ppm. An amended new tolerance was not requested for eggs; the existing tolerance should be increased from 0.02 ppm to 0.05 ppm. In addition, the current tolerances for liver and mbyp (except liver) of cattle, hogs, sheep, goats, and horses should be deleted because they are covered by ``mbyp (except kidney)''. The current tolerance for poultry mbyp, now expressed as ``mbyp (except liver)'' should be expressed in terms of ``mbyp'', and the tolerance for poultry liver should be deleted because it is covered by the tolerance for ``mbyp''. The differences in tolerances determined for these commodities are due to the following. Zeneca used an average of residues measured at the three dosing levels in animal feeding studies to estimate residues for animal commodities. Because residues of the PMG ion (N- (phosphonomethyl)glycine) measured in animal feeding studies were less than the limit of quantitation (LOQ) at lower dosing levels, EPA used residue levels measured at the highest dose rate (1,000 ppm) to calculate residues, resulting in higher values for tolerances for some animal commodities as described above. In addition, requested tolerances for mbyp of cattle, hogs, sheep, goats, and horses were expressed in terms of ''mbyp except kidney and liver``. However, the tolerance levels are higher than those needed to cover residues in liver and, therefore, liver is being deleted from the ``except'' clause. Similarly, existing tolerances for poultry mbyp must be revised to express the tolerance in terms of ``poultry mbyp'' and to delete the tolerance expressions for ``poultry mbyp (except liver)'' and ``poultry liver''.

I. 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).

II. 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 tolerances for residues of sulfosate in or on soybean, seed at 21 ppm (of which no more than 13 ppm is TMS); soybean hulls at 45 ppm (of which no more than 25 ppm is TMS); aspirated grain fractions at 1,300 ppm (of which no more than 720 ppm is TMS); kidney of cattle, hogs, sheep, goats, and horses at 6.0 ppm; mbyp (except kidney) of cattle, hogs, sheep, goats, and horses at 1.5 ppm; meat of cattle, hogs, sheep, goats, and horses at 1.0 ppm; fat of cattle, hogs, sheep, goats, and horses at 0.5 ppm; milk at 1.5 ppm; poultry mbyp at 0.1 ppm; poultry meat at 0.05 ppm; poultry fat at 0.05 ppm; and eggs at 0.05 ppm. EPA's assessment of the dietary exposures and risks associated with establishing the tolerance follows.

A. 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 document published on September 11, 1998 (63 FR 48597)(FRL-6026-6). 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)...''.

B. Toxicological Endpoints

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

C. Exposures and Risks

1. From food and feed uses. Tolerances have been established (40 CFR 180.489) for the residues of sulfosate in or on a variety of raw agricultural commodities. Risk assessments were conducted by EPA to assess dietary exposures from sulfosate as follows: Section 408(b)(2)(E) authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide chemicals that have been measured in food. If EPA relies on such information, EPA must require that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. Following the initial data submission, EPA is authorized to require similar data on a time frame it deems appropriate. As required by section 408(b)(2)(E), EPA will issue a data call-in for information relating to anticipated residues to be submitted no later than 5 years from the date of issuance of this tolerance. Section 408(b)(2)(F) states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if the Agency can make the following findings: That the data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain such pesticide residue; that the exposure estimate does not underestimate exposure for any significant subpopulation group; and if data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area. In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of percent of crop treated (PCT) as required by the section 408(b)(2)(F), EPA may require registrants to submit data on PCT. The Agency used PCT information as follows: For the acute analysis, tolerance level residues and 100% crop treated (CT) were used. For the chronic analysis, tolerance level residues, anticipated residue levels for soybean commodities based on field trial data, treatment of 20 percent of soybeans in the United States with sulfosate, and PCT information obtained from public and proprietary databases for other crops were used. To estimate percent of crop treated, typically a range of estimates are supplied, and the upper end of this range is assumed for the exposure assessment. By using the upper end estimate of percent of crop treated, the Agency is reasonably certain that exposure is not understated for any significant subpopulation group. The registrant submitted a projected market share percentage of 20% for soybeans. EPA scientists determined that this value is a reasonable conservative usage estimate based on comparison to the market share of other herbicides presently applied to herbicide- tolerant crops. Therefore, 20% was used in the chronic analysis for soybeans. For soybeans, the percent of the crop that can be treated with sulfosate will be capped at 14,500,000 acres (20% of the 1998 soybean acreage) by the sulfosate registration. The Agency believes that the three conditions, discussed in section 408 (b)(2)(F) in this unit concerning the Agency's responsibilities in assessing chronic dietary risk findings, have been met. Based on the above information, EPA finds that the PCT information is reliable and has a valid basis. The regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available information on the consumption of food bearing sulfosate in a particular area. i. Acute exposure and risk. Acute food risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. The %PADs (Populated adjusted dose, RfD adjusted for 3x FQPA safety factor, %RfD/3) were below the Agency's level of concern at the 95th percentile for the U.S. population and all subgroups, with the highest exposure of 42% PAD in the subgroup all infants (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 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.

VI. Public Record and Electronic Submissions

EPA has established a record for this regulation under docket control number [OPP-300878] (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.

VII. Regulatory Assessment Requirements

A. 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) (Public Law 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 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.

B. 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.

C. 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.

VIII. 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 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: June 8, 1999.

Peter Caulkins,

Acting 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. 321(q), (346a), and 371.

2. In Sec. 180.489 the table to paragraph (a) is amended as follows: i. By removing the complete entries for cattle, liver; cattle, mbyp except liver; goats, liver; goats, mbyp, except liver; hogs, liver; hogs, mbyp except liver; horses, liver; horses, mbyp except liver; poultry, liver; poultry, mbyp except liver; sheep, liver; and sheep, mbyp except liver. ii. By revising the entries for aspirated grain fractions; cattle, fat; cattle, meat; eggs; goats, fat; goats, meat; hogs, fat; hogs, meat; horses, fat; horses, meat; milk; sheep, fat; sheep, meat; soybean, hulls; and soybean, seed. iii. By adding entries for cattle, kidney; cattle, mbyp (except kidney); goats, kidney; goats, mbyp (except kidney); hogs, kidney; hogs, mbyp (except kidney); horses, kidney; horses, mbyp (except kidney); poultry, mbyp; sheep, kidney; and sheep, mbyp (except kidney). The additions and revisions read as follows:

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

(a) * * *

------------------------------------------------------------------------ Parts per Commodity million ------------------------------------------------------------------------ * * * * * Aspirated grain fractions (of which no more than 720 ppm is 1,300 TMS)...................................................... * * * * * Cattle, fat................................................ 0.5 Cattle, kidney............................................. 6.0 Cattle, mbyp (except kidney)............................... 1.5 Cattle, meat............................................... 1.0 * * * * * Eggs....................................................... 0.05 Goats, fat................................................. 0.5 Goats, kidney.............................................. 6.0 Goats, mbyp (except kidney)................................ 1.5 Goats, meat................................................ 1.0 * * * * * Hogs, fat.................................................. 0.5 Hogs, kidney............................................... 6.0 Hogs, mbyp (except kidney)................................. 1.5 Hogs, meat................................................. 1.0 Horses, fat................................................ 0.5 Horses, kidney............................................. 6.0 Horses, mbyp (except kidney)............................... 1.5 Horses, meat............................................... 1.0 Milk....................................................... 1.5 * * * * * Poultry, mbyp.............................................. 0.1 * * * * * Sheep, fat................................................. 0.5 Sheep, kidney.............................................. 6.0 Sheep, mbyp (except kidney)................................ 1.5 Sheep, meat................................................ 1.0 * * * * * Soybean, hulls (of which no more than 25 ppm is TMS)....... 45 Soybean, seed (of which no more than 13 ppm is TMS)........ 21 * * * * * ------------------------------------------------------------------------

* * * * *

[FR Doc. 99-14994 Filed 6-10-99; 8:45 am] BILLING CODE 6560-50-F