Glyphosate; Pesticide Tolerance, 24188-24190 [E7-8000]
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Federal Register / Vol. 72, No. 84 / Wednesday, May 2, 2007 / Rules and Regulations
A final ‘‘Environmental Analysis
Check List’’ and a final ‘‘Categorical
Exclusion Determination’’ are available
in the docket where indicated under
ADDRESSES.
List of Subjects in 33 CFR Part 165
Harbors, Marine safety, Navigation
(water), Reporting and recordkeeping
requirements, Security measures,
Waterways.
■ For the reasons discussed in the
preamble, the Coast Guard amends 33
CFR part 165 as follows:
PART 165—REGULATED NAVIGATION
AREAS AND LIMITED ACCESS AREAS
1. The authority citation for part 165
continues to read as follows:
■
Authority: 33 U.S.C. 1226, 1231; 46 U.S.C.
Chapter 701; 50 U.S.C. 191, 195; 33 CFR
1.05–1, 6.04–1, 6.04–6, and 160.5; Pub. L.
107–295, 116 Stat. 2064; Department of
Homeland Security Delegation No. 0170.1.
■
2. Add § 165.509 to read as follows:
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§ 165.509 Security Zone; Severn River and
College Creek, Annapolis, MD.
(a) Definitions. For purposes of this
section, the Captain of the Port,
Baltimore, Maryland means the
Commander, Coast Guard Sector
Baltimore, Maryland or any Coast Guard
commissioned, warrant, or petty officer
who has been authorized by the Captain
of the Port, Baltimore, Maryland to act
on his or her behalf.
(b) Location. The following area is a
security zone: All waters of the Severn
River, from shoreline to shoreline,
bounded by a line drawn from
Horseshoe Point, at 38[deg]59’47.6’’ N,
076[deg]29’33.2’’ W; eastward across the
Severn river to a point located at
39[deg]00’01.5’’ N, 076[deg]29’08.5’’ W;
and a line drawn from Biemans Point,
at 38[deg]59’14.4’’ N, 076[deg]28’30.1’’
W; westward across the Severn River to
a point 38[deg]59’03.5’’ N,
076[deg]28’50.0’’ W, located on the
Naval Academy waterfront. This
security zone includes the waters of
College Creek eastward of the King
George Street Bridge (NAD 1983).
(c) Regulations. (1) The general
regulations governing security zones
found in § 165.33 apply to the security
zone described in paragraph (b) of this
section.
(2) Entry into or remaining in this
zone is prohibited unless authorized by
the Coast Guard Captain of the Port,
Baltimore, Maryland.
(3) Persons or vessels requiring entry
into or passage through the security
zone must first request authorization
from the Captain of the Port, Baltimore
to seek permission to transit the area.
The Captain of the Port, Baltimore,
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Maryland can be contacted at telephone
number (410) 576–2693. The Coast
Guard vessels enforcing this section can
be contacted on Marine Band Radio
VHF channel 16 (156.8 MHz). Upon
being hailed by a U.S. Coast Guard
vessel by siren, radio, flashing light, or
other means, the operator of a vessel
shall proceed as directed. If permission
is granted, all persons and vessels must
comply with the instructions of the
Captain of the Port, Baltimore, Maryland
and proceed at the minimum speed
necessary to maintain a safe course
while within the zone.
(d) Enforcement. The U.S. Coast
Guard may be assisted in the patrol and
enforcement of the zone by Federal,
State, and local agencies.
(e) Enforcement period. This section
will be enforced annually on the Friday
before the Memorial Day holiday in May
from 7:30 a.m. to 2 p.m. local time.
Dated: April 20, 2007.
Brian D. Kelley,
Captain, U.S. Coast Guard, Captain of the
Port, Baltimore, Maryland.
[FR Doc. E7–8447 Filed 5–1–07; 8:45 am]
BILLING CODE 4910–15–P
ENVIRONMENTAL PROTECTION
AGENCY
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: 703305-5704; e-mail address:
walters.vickie.epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
40 CFR Part 180
A. Does this Action Apply to Me?
[EPA–HQ–OPP–2006–0323; FRL–8122–8]
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:
<bullet≤ Crop production (NAICS
code 111), e.g., agricultural workers;
greenhouse, nursery, and floriculture
workers; farmers.
<bullet≤ Animal production (NAICS
code 112), e.g., cattle ranchers and
farmers, dairy cattle farmers, livestock
farmers.
<bullet≤ Food manufacturing (NAICS
code 311), e.g., agricultural workers;
farmers; greenhouse, nursery, and
floriculture workers; ranchers; pesticide
applicators.
<bullet≤ 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
Glyphosate; Pesticide Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
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 Act
(FFDCA).
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
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Federal Register / Vol. 72, No. 84 / Wednesday, May 2, 2007 / Rules and Regulations
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.
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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:
<bullet≤ Federal eRulemaking Portal:
http://www.regulations.gov. Follow the
on-line instructions for submitting
comments.
<bullet≤ Mail: Office of Pesticide
Programs (OPP) Regulatory Public
Docket (7502P), Environmental
Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
<bullet≤ Delivery: OPP Regulatory
Public Docket (7502P), Environmental
Protection Agency, Rm. S-4400, One
Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. Deliveries
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02:49 Aug 19, 2011
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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) 3055805.
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 (nphosphonemethyl)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
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24189
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 include
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Federal Register / Vol. 72, No. 84 / Wednesday, May 2, 2007 / Rules and Regulations
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:
residuemethods@epa.gov.
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.
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V. Conclusion
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
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02:49 Aug 19, 2011
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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 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).
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
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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: April 17, 2007.
Lois Rossi,
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. Section 180.364, paragraph (a) is
amended by revising the introductory
text to read as follows:
■
§ 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]
BILLING CODE 6560–50–S
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Part 73
[DA 07–1715; MB Docket No. 05–328; RM–
10577; RM–11343; RM–11344]
Radio Broadcasting Service; Broken
Bow and Millerton, OK
Federal Communications
Commission.
ACTION: Final rule.
AGENCY:
SUMMARY: The Audio Division: grants a
counterproposal (RM–11343) filed by
Charles Crawford to allot Channel
265C2 at Millerton, Oklahoma;
dismisses a petition for rule making
(RM–10577) per petitioner Jeraldine
E:\FEDREG\02MYR1.LOC
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]]>Agencies
[Federal Register Volume 72, Number 84 (Wednesday, May 2, 2007)]
[Rules and Regulations]
[Pages 24188-24190]
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
[EPA-HQ-OPP-2006-0323; FRL-8122-8]
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
Act (FFDCA).
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.
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), 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
[[Page 24189]]
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
include
[[Page 24190]]
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:
residuemethods@epa.gov.
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.
V. Conclusion
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
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).
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: April 17, 2007.
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, 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]
BILLING CODE 6560-50-S
