[Federal Register Volume 64, Number 81 (Wednesday, April 28, 1999)]
[Rules and Regulations]
[Pages 22802-22806]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-10520]


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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.

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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 filed with 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 filed with the Hearing 
Clerk may be submitted electronically by sending electronic mail (e-
mail) to: [email protected]. 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 filed online 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, 
[email protected].

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.

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 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

[[Page 22803]]

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.

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 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)...''

B. 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).

C. 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).

D. 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).

E. 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).

III. Other Considerations

A. 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.

B. 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).

C. Magnitude of Residues

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

D. 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.

E. Rotational Crop Restrictions

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

IV. 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.

V. 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 filed with 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, [email protected]. 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

[[Page 22804]]

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-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:
    [email protected].


    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) (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.

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

[[Page 22805]]

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:


 
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                            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



[[Page 22806]]

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 99-10520 Filed 4-27-99; 8:45 am]
BILLING CODE 6560-50-F