[Federal Register Volume 72, Number 84 (Wednesday, May 2, 2007)]
[Rules and Regulations]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-8000]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Glyphosate; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation amends the tolerance expression for glyphosate
to include the dimethylamine (DMA) salt of glyphosate. Dow AgroScienes,
LLC requested this tolerance under the Federal Food, Drug, and Cosmetic
DATES: This regulation is effective May 2, 2007. Objections and
requests for hearings must be received on or before July 2, 2007, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION ).
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2006-0323. To access the
electronic docket, go to http://www.regulations.gov, select ``Advanced
Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov web site to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available in the electronic docket at http://www.regulations.gov,or, if
only available in hard copy, at the OPP Regulatory Public Docket in Rm.
S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington,
VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket telephone number
is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Vickie Walters, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: 703-305-5704; e-mail address: walters.vickie.epa.gov.
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
Crop production (NAICS code 111), e.g., agricultural
workers; greenhouse, nursery, and floriculture workers; farmers.
Animal production (NAICS code 112), e.g., cattle ranchers
and farmers, dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS code 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
Pesticide manufacturing (NAICS code 32532), e.g.,
agricultural workers; commercial applicators; farmers; greenhouse,
nursery, and floriculture workers; residential users.
This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining whether this action might apply to
certain entities. If you have any questions regarding the applicability
of this action to a particular entity, consult the person listed under
FOR FURTHER INFORMATION CONTACT.
B. How Can I Access Electronic Copies of this Document?
In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://www.regulations.gov, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of EPA's tolerance regulations at
40 CFR part 180 through the Government Printing Office's pilot e-CFR
site at http://www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of the FFDCA, any person may file an objection
to any aspect of this regulation and may also request a hearing on
those objections. You must file your objection or request a hearing on
this regulation in accordance with the instructions provided in 40 CFR
part 178. To ensure proper receipt by EPA, you must identify docket ID
number EPA-HQ-OPP-2006-0323 in the subject line on the first page of
your submission. All requests must be in writing, and must be mailed or
delivered to the Hearing Clerk as required by 40 CFR part 178 on or
before July 2, 2007.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2006-0323, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket telephone number is (703) 305-5805.
II. Petition for Tolerance
In the Federal Register of February 7, 2007 (72 FR 5706) (FRL-8111-
8), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
6F7025) by Dow AgroSciences, LLC, 9330 Zionsville Rd, Indianapolis, IN
46268 . The petition requested that 40 CFR 180. 364 (a) be amended by
adding glyphosate dimethylammoniun salt or dimethalamine salt of
glyphosate (n-phosphonemethyl)glycine resulting from the application of
glyphosate and the isopropylamine salt of glyphosate, ethanolamine salt
of glyphosate, and the ammonium potassium salt of glyphosate. That
notice referenced a summary of the petition prepared by Dow
AgroSciences, LLC, the registrant, which has been placed in the public
docket, http://www.regulations.gov. Dow requested this change to
support registration of pesticide products containing the dimethylamine
salt of glyphosate. There were no comments received in response to the
notice of filing.
Based upon review of the data supporting the petition, EPA is
revising the tolerance expression for 40 CFR 180.364 (a) to read:
``Tolerances are established for residues of glyphosate N-
(phosphonomethyl)glycine resulting from the application of glyphosate,
the isoprpylamine salt of glyphosate, the ethanolamine salt of
glyphosate, and the dimethylamine salt of glyphosate, the ammonium salt
of glyphosate, the potassium salt of glyphosate, in or on the following
food commodities:'' This change corrects a spelling error that occurred
in the notice of filing and deletes glyphosate dimethylammonium salt,
as this is another name for the dimethylamine salt of glyphosate.
III. Aggregate Risk Assessment and Determination of Safety
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) of the FFDCA 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) of the FFDCA 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. . .
.'' These provisions were added to the FFDCA by the Food Quality
Protection Act (FQPA) of 1996.
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in 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 and to make a
determination on aggregate exposure for the petitioned- revising the
tolerance expression for 40 CFR 180.364 (a) to read: ``Tolerances are
established for residues of glyphosate N-(phosphonomethyl)glycine
resulting from the application of glyphosate, the isopropylamine salt
of glyphosate, the ethanolamine salt of glyphosate, the dimethylamine
salt of glyphosate, the ammonium salt of glyphosate, and the potassium
salt of glyphosate, in or on the following food commodities.'' The DMA
salt of glyphosate dissociates to glyphosate and the dimethylamine ion.
Because the DMA salt disassociates to glyphosate acid, as does the
currently listed salts, no increased tolerances or risks are expected
from the addition of the dimethylamine salt of glyphosate to the
tolerance expression. Toxicological profile and current risk
assessments for glyphosate are discussed in the final rule published in
the Federal Register of December 20, 2006 (71 FR 76180) (FRL-8105-9)
which established tolerances for residues of glyphosate in or on
sunflower; safflower; noni; pea, dry; and vegetable, legume, group 6
except soybean and pea, dry. Based on the risk assessments discussed in
the notice above, EPA concludes that there is a reasonable certainty
that no harm will result to the general population and to infants and
children from aggregate exposure glyphosate residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methods are available for analysis of residues
of glyphosate in or on plant and livestock commodities. These methods
gas liquid chromatography (GLC) (Method I in Pesticides Analytical
Manual (PAM II; the limit of detection is 0.05 part per million (ppm))
and High Performance Liquid Chromatography (HPLC) with fluorometric
detection. The HPLC procedure has undergone successful Agency
validation, and was recommended for inclusion in PAM II. A gas
chromatography/mass spectrometry (GC/MS) method for glyphosate crops
has also been validated by EPA's Analytical Chemistry Laboratory (ACL).
The HPLC and GC/MS methods may be requested from: Chief, Analytical
Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address:
B. International Residue Limits
Codex and Mexican maximum residue levels (MRLS) are established for
residues of glyphosate per se and Canadian MRLs are established for the
combined residues of glyphosate and animomethylphosphonic acid (AMPA)
on a variety raw agricultural commodities. No international
harmonization issues are associated with the addition of the
dimethylamine salt of glyphosate to the tolerance expression.
Therefore, tolerance expression for 40 CFR 180.364 (a) is revised
to read: ``Tolerances are established for residues of glyphosate N-
(phosphonomethyl)glycine resulting from the application of glyphosate,
the isoprpylamine salt of glyphosate, the ethanolamine salt of
glyphosate, the dimethylamine salt of glyphosate, the ammonium salt of
glyphosate, and the potassium salt of glyphosate, in or on the
following food commodities.''
VI. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of
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). Because this rule has been
exempted from review under Executive Order 12866, this rule is not
subject to Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001) or Executive Order 13045, entitled Protection of Children
from Environmental Health Risks and Safety Risks (62 FR 19885, April
23, 1997). 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., nor does it require any special considerations
under Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance 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.
This final rule directly regulates growers, food processors, food
handlers and food retailers, not States or tribes, nor does this action
alter the relationships or distribution of power and responsibilities
established by Congress in the preemption provisions of section
408(n)(4) of FFDCA. As such, the Agency has determined that this action
will not have a substantial direct effect on States or tribal
governments, on the relationship between the national government and
the States or tribal governments, or on the distribution of power and
responsibilities among the various levels of government or between the
Federal Government and Indian tribes. Thus, the Agency has determined
that Executive Order 13132, entitled Federalism (64 FR 43255, August
10, 1999) and Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000) do not apply to this rule. In addition, This rule does not 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
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report 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 this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
Dated: April 17, 2007.
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.364, paragraph (a) is amended by revising the
introductory text to read as follows:
Sec. 180.364 Glyphosate; tolerances for residues.
(a) General. Tolerances are established for residues of glyphosate
N-(phosphonomethyl)glycine resulting from the application of
glyphosate, the isopropylamine salt of glyphosate, the ethanolamine
salt of glyphosate, the dimethylamine salt of glyphosate, the ammonium
salt of glyphosate, and the potassium salt of glyphosate in or on the
following food commodities:
* * * * *
[FR Doc. E7-8000 Filed 5-1-07; 8:45 am]
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