[Federal Register: June 24, 2009 (Volume 74, Number 120)]
[Rules and Regulations]
[Page 29963-29966]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24jn09-17]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2009-0007; FRL-8417-5]
Glyphosate; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation increases the tolerance for residues of
glyphosate in or on cotton, gin byproducts. Cheminova, Inc requested
these tolerances under the Federal Food, Drug, and Cosmetic Act
(FFDCA).
DATES: This regulation is effective June 24, 2009. Objections and
requests for hearings must be received on or before August 24, 2009,
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-2009-0007. All documents in the
docket are listed in the docket index available at http://
www.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 Facility 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.
SUPPLEMENTARY INFORMATION:
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).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
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 electronically available documents 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 e-CFR cite
at http://www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file
an objection to any aspect of this regulation
[[Page 29964]]
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-2009-0007 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 August 24, 2009.
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-2009-0007, 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 Facility'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 Facility telephone number is (703) 305-5805.
II. Petition for Tolerance
In the Federal Register of March 25, 2009 (74 FR 12857) (FRL-8399-
4), 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
8F7451) by Cheminova, One Park Drive, Research Triangle Park, NC 27707.
The petition requested that 40 CFR 180.364 be amended by establishing
tolerances for residues of the herbicide glyphosate, N-
(phosphonomethyl)glycine, resulting from the application of glyphosate,
the isoproplyamine 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 cotton, gin
byproducts at 210 parts per million (ppm). That notice referenced a
summary of the petition prepared by Cheminova. Inc, the registrant,
which is available to the public in the docket, http://
www.regulations.gov. Comments were received on the notice of filing.
EPA's response to these comments is discussed in Unit IV.C.
Cheminova, Inc has requested a Section 3 registration under the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) for
application of glyphosate to glyphosate tolerant cotton including Bayer
GHB614 cotton (GlyTol cotton), a genetically modified cotton being
commercialized by Bayer Crop Science. As a result, the petitioner has
requested that the current tolerance for cotton, gin byproducts be
increased to 210 ppm. This petition was filed in conjunction with
Cheminova's requested change to its FIFRA registration.
Based upon review of the data supporting the petition, EPA has
determined that the proposed tolerance in this petition should remain
in 40CFR180.364 (a)(1) which reads: Tolerances are established for
residues of the herbicide glyphosate, N-(phosphonomethyl)glycine,
resulting from the application of glyphosate, the isoproplyamine salt
of glyphosate, the ethanolamine salt of glyphosate, the dimethylamine
salt of glyphosate, the ammonium salt of glyphosate, and the potassium
salt of glyphosate on the following food commodities. The proposed
numerical value for the proposed tolerance on cotton, gin byproducts
remains 210 ppm.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of 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 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 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....''
Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, 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-for
tolerances for residues of glyphosate on cotton, gin by products at 210
ppm. EPA's assessment of exposures and risks associated with
establishing tolerances 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. Specific information on the studies received and the nature
of the adverse effects caused by glyphosate as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies are discussed in the rule
making document referenced in this unit. A summary of the toxicological
endpoints and current risk assessments for glyphosate can be found in
the same rule making document.
In amending the glyphosate cotton, gin byproducts tolerance, EPA
relies on the risk assessment and safety finding made in the final rule
published in the Federal Register of December 20, 2006 (71 FR 73586)
(FRL-8385-7) which established tolerances for residues of glyphosate in
or on noni at 0.20 ppm and various other commodities. For the reasons
explained in this unit, increasing the cotton, gin byproducts tolerance
to 210 ppm does not change the human exposure and risk to glyphosate as
set forth in that 2006 rulemaking. Accordingly, EPA herein adopts the
safety findings in that rulemaking.
Increasing the current glyphosate tolerance for cotton, gin
byproducts to 210 ppm does not result in changes in the exposure or
risk estimates reported in the previous risk assessments for the
reasons listed in this unit and discussed in the Agency review entitled
Glyphosate Label Amendment to Permit Application of Glyphosate to
Bayer's Glyphosate-Tolerant Cotton GHB614., available at
www.regulations.gov in Docket ID number EPA-HQ-OPP-2009-0007 and
identified as EPA-HQ-OPP-2009-0007-0002.
[[Page 29965]]
1. Glyphosate is currently registered for application to cotton
genetically modified to express the Agrobacterium EPSPS gene. Available
information indicate that Bayer GHB614 cotton (GlyTol Cotton) has been
genetically modified to produce the 2mEPSPS protein which is not
inhibited by glyphosate. The 2mEPSPS gene was generated by introducing
mutations into the wild maize gene. The 2mEPSPs protein differs from
the wild maize EPSPS protein by two amino acids. Based on the current
metabolism data and because tolerance to glyphosate in GHB614 cotton is
conferred via modification of an endogenous plant EPSPS gene so that
the plant is no longer sensitive (i.e. tolerance is not conveyed via
metabolism of the herbicide), the Agency concludes that previous
conclusions concerning the residues of concern for tolerance expression
and risk assessment are applicable to GHB614 cotton (i.e. the residues
of concern for tolerance expression and risk assessment are glyphosate
per se).
2. The numerical value of all but one feed tolerance will remain
the same.
3. The most recent dietary analysis assumed tolerance level
residues and 100% crop treated.
4. The estimate of glyphosate levels in drinking water is based on
a glyphosate use involving direct application to water at 3.75 pounds
active ingredient per acre. The proposed use pattern is the same as the
currently registered use pattern on glyphosate tolerant cotton. Use of
glyphosate on GlyTol Cotton will not result in higher levels in
drinking water.
5. Previously calculated dietary burden to beef and dairy cattle
were based on alfalfa hay (400 ppm tolerance) being the significant
contributor to the diet. Because cotton, gin byproducts constitute a
minor feed commodity (5% of the beef cattle and not feed to dairy
cattle), the Agency concludes that the increase in cotton, gin
byproducts tolerance to 210 ppm will not significantly affect the
magnitude of the residue in livestock. Therefore, no increase in
currently established livestock tolerances is necessary.
6. Previously calculated dietary burden to poultry were based on
alfalfa meal (400 ppm). The previously calculated dietary burden to hog
was based on alfalfa meal and barley grain (20 ppm). The numerical
values for these commodities remain unchanged. Cotton, gin byproducts
are not feed to poultry and hog. Therefore, the Agency concludes that
the increase in the cotton, gin byproducts tolerance to 210 ppm will
not significantly affect the magnitude of the residue in poultry or
hog, and no increases in tolerance for these commodities are necessary.
Therefore, based on the risk assessments discussed in the notices
referenced above, EPA concludes that no harm will result to the general
population or to infants and children from aggregate exposure to
glyphosate residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (high performance liquid
chromatography (HPLC) with fluorometric detection and gas
chromatography with mass spectrometry (GC/MS)) are available to enforce
the tolerance expression. The 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: residuemethods@epa.gov.
B. International Residue Limits
There are no Codex MRLs for glyphosate on cotton, gin byproducts.
MRLs are not set for cotton, gin byproduct, as it is not considered a
major item in international trade. No Canadian or Mexican MRLs exist
for glyphosate on cotton, gin byproducts.
C. Response to Comments
One comment was received from a private citizen objecting to the
establishment of tolerances. The Agency has received similar comments
from this commenter on numerous previous occasions. Refer to the
Federal Register of March 14, 2007 (72 FR 11784; FRL-8117-2) for the
Agency response to these objections.
V. Conclusion
Therefore, tolerances are established for residues of glyphosate,
N-(phosphonomethyl)glycine, resulting from the application of
glyphosate, the isoproplyamine salt of glyphosate, the ethanolamine
salt of glyphosate, the dimethylamine salt of glyphosate, the ammonium
salt of glyphosate, and the potassium salt of glyphosate on cotton, gin
byproducts at 210 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances 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 final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled 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 9, 2000) do not apply to this final rule. In addition,
this final 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 104-4).
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
note).
[[Page 29966]]
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
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 11, 2009.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.364 is amended by revising the following entry in the
table in paragraph (a)(1) to read as follows:
Sec. 180.364 Glyphosate; tolerances for residues.
(a) General. (1) * * *
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
* * * * *
Cotton, gin byproducts............................... 210
* * * * *
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* * * * *
[FR Doc. E9-14594 Filed 6-23-09; 8:45 am]
BILLING CODE 6560-50-S