Glyphosate; Pesticide Tolerances, 60707-60709 [2013-24128]
Download as PDF
60707
Federal Register / Vol. 78, No. 191 / Wednesday, October 2, 2013 / Rules and Regulations
ILLINOIS—PM2.5
[Annual NAAQS]
Designation a
Designated area
Date 1
Chicago-Gary-Lake County, IL–IN .....................................................................................................................
Cook County
DuPage County
Grundy County (part)
Goose Lake and Aux Sable Townships
Kane County
Kendall County (part)
Oswego Township
Lake County
McHenry County
Will County
*
*
*
*
*
10–2–13
*
Type
Attainment.
*
a Includes
Indian Country located in each county or area, except as otherwise specified.
1 This date is 90 days after January 5, 2005, unless otherwise noted.
*
*
*
*
NW., Washington, DC 20460–0001. The
Public Reading Room is open from 8:30
a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The
telephone number for the Public
Reading Room is (202) 566–1744, and
the telephone number for the OPP
Docket is (703) 305–5805. Please review
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
*
[FR Doc. 2013–23952 Filed 10–1–13; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2011–0307; FRL–9396–6]
Glyphosate; Pesticide Tolerances
This regulation amends the
established tolerance for residues of the
herbicide glyphosate in or on canola,
seed at 20 parts per million (ppm) by
changing the tolerance expression from
the combined residues of glyphosate
only, to the combined residues of
glyphosate and N-acetyl-glyphosate
(expressed as glyphosate equivalents).
E.I. du Pont de Nemours and Company
requested this change under the Federal
Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective
October 2, 2013. Objections and
requests for hearings must be received
on or before December 2, 2013, 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: The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2011–0307, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West
Bldg., Rm. 3334, 1301 Constitution Ave.
sroberts on DSK5SPTVN1PROD with RULES
SUMMARY:
VerDate Mar<15>2010
15:59 Oct 01, 2013
Jkt 232001
Lois
Rossi, Registration Division (7505P),
Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; telephone number:
(703) 305–7090; email address:
RDFRNotices@epa.gov.
FOR FURTHER INFORMATION CONTACT:
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
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. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
PO 00000
Frm 00055
Fmt 4700
Sfmt 4700
B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
site at https://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl. To access the OCSPP test
guidelines referenced in this document
electronically, please go to https://
www.epa.gov/ocspp and select ‘‘Test
Methods and Guidelines.’’
C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a, 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–2011–0307 in the subject line on
the first page of your submission. All
objections and requests for a hearing
must be in writing, and must be
received by the Hearing Clerk on or
before December 2, 2013. Addresses for
mail and hand delivery of objections
and hearing requests are provided in 40
CFR 178.25(b).
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 (excluding
any Confidential Business Information
(CBI)) for inclusion in the public docket.
Information not marked confidential
pursuant to 40 CFR part 2 may be
disclosed publicly by EPA without prior
notice. Submit the non-CBI copy of your
objection or hearing request, identified
E:\FR\FM\02OCR1.SGM
02OCR1
60708
Federal Register / Vol. 78, No. 191 / Wednesday, October 2, 2013 / Rules and Regulations
by docket ID number EPA–HQ–OPP–
2011–0307, by one of the following
methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
Do not submit electronically any
information you consider to be CBI or
other information whose disclosure is
restricted by statute.
• Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/
DC), (28221T), 1200 Pennsylvania Ave.
NW., Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/contacts.htm.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at https://
www.epa.gov/dockets.
sroberts on DSK5SPTVN1PROD with RULES
II. Summary of Petitioned-For
Tolerance
In the Federal Register of April 20,
2011 (76 FR 22067) (FRL–8869–7), EPA
issued a document pursuant to FFDCA
section 408(d)(3), 21 U.S.C. 346a(d)(3),
announcing the filing of a pesticide
petition (PP 1F7840) by E.I. du Pont de
Nemours and Company, 1007 Market
Street, Wilmington, DE 19898. The
petition requested that 40 CFR 180.364
be amended by changing the tolerance
expression for residues of the herbicide
glyphosate in or on canola, seed at 20
ppm from the combined residues of
glyphosate only to the combined
residues of glyphosate and N-acetylglyphosate (expressed as glyphosate
equivalents) to account for application
of glyphosate to the genetically
modified ‘‘Optimum GLY’’ canola. That
document referenced a summary of the
petition prepared by E.I. du Pont de
Nemours and Company, the registrant,
which is available in the docket, https://
www.regulations.gov. There were no
comments received in response to the
notice of filing.
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
VerDate Mar<15>2010
15:59 Oct 01, 2013
Jkt 232001
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 FFDCA section
408(b)(2)(D), and the factors specified in
FFDCA 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 glyphosate
including exposure resulting from the
tolerances established by this action.
EPA’s assessment of exposures and risks
associated with glyphosate follows.
In the Federal Register of May 1, 2013
(78 FR 25396) (FRL–9384–3), EPA
issued a final rule establishing a
tolerance for residues of glyphosate in
or on several commodities. No new
toxicological data was submitted since
EPA established this regulation. The
current regulation does not alter
exposure levels to glyphosate and thus
does not require a change in tolerance
levels for canola seed. The transfer of
the tolerance for canola seed from 40
CFR 180.364(a)(1) to 180.364(a)(2) does
not change the estimated aggregate risks
resulting from the use of glyphosate, as
discussed in the preamble to the May 1,
2013 final rule. Refer to the Federal
Register document, available at https://
www.regulations.gov, for a detailed
discussion of the aggregate risk
assessment and determination of safety.
Therefore, based on the risk
assessment discussed in the preamble to
the final rule published in the Federal
Register of May 1, 2013 (78 FR 25396),
EPA concludes that there is a reasonable
certainty that no harm will result to the
general population, or to infants and
children from aggregate exposure to
glyphosate residues.
email address: residuemethods@
epa.gov.
IV. Other Considerations
VI. Statutory and Executive Order
Reviews
This final rule establishes a tolerance
under FFDCA section 408(d) 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
A. Analytical Enforcement Methodology
Adequate enforcement methodology
(DuPont liquid chromatography/mass
spectrometry/mass spectrometry
Method 15444) is available to enforce
the tolerance expression. The method
may be requested from: Chief,
Analytical Chemistry Branch,
Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755–5350;
telephone number: (410) 305–2905;
PO 00000
Frm 00056
Fmt 4700
Sfmt 4700
B. International Residue Limits
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
international standards whenever
possible, consistent with U.S. food
safety standards and agricultural
practices. EPA considers the
international maximum residue limits
(MRLs) established by the Codex
Alimentarius Commission (Codex), as
required by FFDCA section 408(b)(4).
The Codex Alimentarius is a joint
United Nations Food and Agriculture
Organization/World Health
Organization food standards program,
and it is recognized as an international
food safety standards-setting
organization in trade agreements to
which the United States is a party. EPA
may establish a tolerance that is
different from a Codex MRL; however,
FFDCA section 408(b)(4) requires that
EPA explain the reasons for departing
from the Codex level.
The Codex has established a MRL for
glyphosate in or on canola at 20 ppm for
residues of glyphosate only. The U.S.
tolerance is established on canola at 20
ppm for the combined residues of
glyphosate and N-acetyl-glyphosate to
account for application of glyphosate to
genetically modified ‘‘Optimum GLY’’
canola, which metabolizes glyphosate
differently than any previous canola
varieties. Therefore, the Codex MRL and
the U.S. tolerance cannot be
harmonized.
V. Conclusion
Therefore, this regulation amends the
established tolerance for residues of the
herbicide glyphosate in or on canola,
seed at 20 ppm by redesignating it from
40 CFR 180.364(a)(1), where compliance
with the tolerance expression is
determined by measuring the combined
residues of glyphosate only, to 40 CFR
180.364(a)(2), where compliance with
the tolerance is determined by
measuring the combined residues of
glyphosate and N-acetyl-glyphosate
(expressed as glyphosate equivalents).
E:\FR\FM\02OCR1.SGM
02OCR1
sroberts on DSK5SPTVN1PROD with RULES
Federal Register / Vol. 78, No. 191 / Wednesday, October 2, 2013 / Rules and Regulations
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 FFDCA section 408(d), 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 FFDCA section 408(n)(4). 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) (2 U.S.C. 1501 et seq.).
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) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), EPA will
VerDate Mar<15>2010
15:59 Oct 01, 2013
Jkt 232001
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of the rule in the Federal
Register. This action 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: September 26, 2013.
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. In § 180.364, remove the entry for
‘‘Canola, seed’’ from the table in
paragraph (a)(1) and add alphabetically
‘‘Canola, seed’’ to the table in paragraph
(a)(2) to read as follows:
■
§ 180.364 Glyphosate; tolerances for
residues.
(a) * * *
(2) * * *
Parts per
million
Commodity
Canola, seed ........................
*
*
*
20
*
*
60709
superseded by tolerances established by
this document. Interregional Research
Project Number 4 (IR–4) requested these
tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective
October 2, 2013. Objections and
requests for hearings must be received
on or before December 2, 2013, 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: The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2012–0912, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West
Bldg., Rm. 3334, 1301 Constitution Ave.
NW., Washington, DC 20460–0001. The
Public Reading Room is open from 8:30
a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The
telephone number for the Public
Reading Room is (202) 566–1744, and
the telephone number for the OPP
Docket is (703) 305–5805. Please review
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Lois
Rossi, Registration Division (7505P),
Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; telephone number:
(703) 305–7090; email address:
RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
*
*
*
*
*
[FR Doc. 2013–24128 Filed 10–1–13; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2012–0912; FRL–9399–6]
Methoxyfenozide; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of
methoxyfenozide in or on multiple
commodities which are identified and
discussed later in this document.
Additionally, this regulation removes
several established time-limited and
permanent tolerances, as they will be
SUMMARY:
PO 00000
Frm 00057
Fmt 4700
Sfmt 4700
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. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of EPA’s tolerance
E:\FR\FM\02OCR1.SGM
02OCR1
Agencies
[Federal Register Volume 78, Number 191 (Wednesday, October 2, 2013)]
[Rules and Regulations]
[Pages 60707-60709]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-24128]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2011-0307; FRL-9396-6]
Glyphosate; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation amends the established tolerance for residues
of the herbicide glyphosate in or on canola, seed at 20 parts per
million (ppm) by changing the tolerance expression from the combined
residues of glyphosate only, to the combined residues of glyphosate and
N-acetyl-glyphosate (expressed as glyphosate equivalents). E.I. du Pont
de Nemours and Company requested this change under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective October 2, 2013. Objections and
requests for hearings must be received on or before December 2, 2013,
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: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2011-0307, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number: (703) 305-7090; email address: RDFRNotices@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.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP
test guidelines referenced in this document electronically, please go
to https://www.epa.gov/ocspp and select ``Test Methods and Guidelines.''
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, 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-2011-0307 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
December 2, 2013. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
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 (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified
[[Page 60708]]
by docket ID number EPA-HQ-OPP-2011-0307, by one of the following
methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/contacts.htm.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
II. Summary of Petitioned-For Tolerance
In the Federal Register of April 20, 2011 (76 FR 22067) (FRL-8869-
7), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
1F7840) by E.I. du Pont de Nemours and Company, 1007 Market Street,
Wilmington, DE 19898. The petition requested that 40 CFR 180.364 be
amended by changing the tolerance expression for residues of the
herbicide glyphosate in or on canola, seed at 20 ppm from the combined
residues of glyphosate only to the combined residues of glyphosate and
N-acetyl-glyphosate (expressed as glyphosate equivalents) to account
for application of glyphosate to the genetically modified ``Optimum
GLY'' canola. That document referenced a summary of the petition
prepared by E.I. du Pont de Nemours and Company, the registrant, which
is available in the docket, https://www.regulations.gov. There were no
comments received in response to the notice of filing.
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 FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA 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 glyphosate including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with glyphosate follows.
In the Federal Register of May 1, 2013 (78 FR 25396) (FRL-9384-3),
EPA issued a final rule establishing a tolerance for residues of
glyphosate in or on several commodities. No new toxicological data was
submitted since EPA established this regulation. The current regulation
does not alter exposure levels to glyphosate and thus does not require
a change in tolerance levels for canola seed. The transfer of the
tolerance for canola seed from 40 CFR 180.364(a)(1) to 180.364(a)(2)
does not change the estimated aggregate risks resulting from the use of
glyphosate, as discussed in the preamble to the May 1, 2013 final rule.
Refer to the Federal Register document, available at https://www.regulations.gov, for a detailed discussion of the aggregate risk
assessment and determination of safety.
Therefore, based on the risk assessment discussed in the preamble
to the final rule published in the Federal Register of May 1, 2013 (78
FR 25396), EPA concludes that there is a reasonable certainty 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 (DuPont liquid chromatography/mass
spectrometry/mass spectrometry Method 15444) is available to enforce
the tolerance expression. The method may be requested from: Chief,
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes
Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email
address: residuemethods@epa.gov.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has established a MRL for glyphosate in or on canola at
20 ppm for residues of glyphosate only. The U.S. tolerance is
established on canola at 20 ppm for the combined residues of glyphosate
and N-acetyl-glyphosate to account for application of glyphosate to
genetically modified ``Optimum GLY'' canola, which metabolizes
glyphosate differently than any previous canola varieties. Therefore,
the Codex MRL and the U.S. tolerance cannot be harmonized.
V. Conclusion
Therefore, this regulation amends the established tolerance for
residues of the herbicide glyphosate in or on canola, seed at 20 ppm by
redesignating it from 40 CFR 180.364(a)(1), where compliance with the
tolerance expression is determined by measuring the combined residues
of glyphosate only, to 40 CFR 180.364(a)(2), where compliance with the
tolerance is determined by measuring the combined residues of
glyphosate and N-acetyl-glyphosate (expressed as glyphosate
equivalents).
VI. Statutory and Executive Order Reviews
This final rule establishes a tolerance under FFDCA section 408(d)
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
[[Page 60709]]
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 FFDCA section 408(d), 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 FFDCA section 408(n)(4). 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) (2 U.S.C. 1501 et seq.).
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) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action 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: September 26, 2013.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
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. In Sec. 180.364, remove the entry for ``Canola, seed'' from the
table in paragraph (a)(1) and add alphabetically ``Canola, seed'' to
the table in paragraph (a)(2) to read as follows:
Sec. 180.364 Glyphosate; tolerances for residues.
(a) * * *
(2) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Canola, seed............................................ 20
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2013-24128 Filed 10-1-13; 8:45 am]
BILLING CODE 6560-50-P