Atrazine; Pesticide Tolerances, 37850-37852 [E8-15010]
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37850
Federal Register / Vol. 73, No. 128 / Wednesday, July 2, 2008 / Rules and Regulations
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 174
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: June 10, 2008.
Janet L. Andersen,
Director, Biopesticides and Pollution
Prevention Division, Office of Pesticide
Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 174—[AMENDed]
1. The authority citation for part 174
continues to read as follows:
I
Authority: 7 U.S.C. 136-136y; 21 U.S.C.
346a and 371.
§ 174.503
[Removed]
2. Section 174.503 is removed.
3. Section 174.519 is revised to read
as follows:
I
I
§ 174.519 Bacillus thuringiensis Cry2Ab2
protein in corn and cotton; exemption from
the requirement of a tolerance.
Residues of Bacillus thuringiensis
Cry2Ab2 protein in or on corn or cotton
are exempt from the requirement of a
tolerance when used as a plant–
incorporated protectant in the food and
feed commodities of corn; corn, field;
corn, sweet; corn, pop; and cotton seed,
cotton oil, cotton meal, cotton hay,
cotton hulls, cotton forage, and cotton
gin byproducts.
[FR Doc. E8–14794 Filed 7–1–08; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
I. General Information
[EPA–HQ–OPP–2006–0192; FRL–8364–1]
Atrazine; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
mstockstill on PROD1PC66 with RULES
AGENCY:
SUMMARY: This regulation establishes
tolerances for residues of atrazine in or
on vegetable, leafy, except brassica,
group 4. Syngenta Crop Protection Inc.
requested these tolerances under the
Federal Food, Drug, and Cosmetic Act
(FFDCA).
This regulation is effective July
2, 2008. Objections and requests for
hearings must be received on or before
DATES:
VerDate Aug<31>2005
17:12 Jul 01, 2008
September 2, 2008, 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–2006–0192. To access the
electronic docket, go to https://
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
website 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
https://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:
Hope Johnson, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–5410; e-mail address:
johnson.hope@epa.gov.
SUPPLEMENTARY INFORMATION:
Jkt 214001
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
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for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Access Electronic Copies
of this Document?
In addition to accessing an electronic
copy of this Federal Register document
through the electronic docket at https://
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://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 https://www.gpoaccess.gov/
ecfr.
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of 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–2006–0192 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 September 2, 2008.
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–2006–0192, by one of the
following methods:
• Federal eRulemaking Portal: https://
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
E:\FR\FM\02JYR1.SGM
02JYR1
Federal Register / Vol. 73, No. 128 / Wednesday, July 2, 2008 / Rules and Regulations
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 Facility telephone number is
(703) 305–5805.
mstockstill on PROD1PC66 with RULES
II. Petition for Tolerance
In the Federal Register of August 15,
2006 (71 FR 46911) (FRL–8064–1), 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 6F7022) by
Syngenta Crop Protection Inc., P.O. Box
18300, Greensboro, NC 27409. The
petition requested that 40 CFR 180.220
be amended by establishing tolerances
for residues of the herbicide atrazine, 2chloro-4-ethylamino-6-isopropylaminos-triazine, in or on leafy vegetables
(excluding brassica) at 0.60 parts per
million (ppm). That notice referenced a
summary of the petition prepared by
Syngenta Crop Protection Inc., the
registrant, which is available to the
public in the docket, https://
www.regulations.gov. Comments were
received on the notice of filing. EPA’s
response to these comments is
discussed in Unit IV.C.
Based upon review of the data
supporting the petition, EPA has
concluded that a tolerance level of 0.25
ppm shall be established for the raw
agricultural commodities vegetable,
leafy, except brassica, group 4. The
reason for these changes are explained
in Unit IV.D.
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
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17:12 Jul 01, 2008
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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 atrazine on
vegetable, leafy, except brassica, group 4
at 0.25 ppm. EPA’s assessment of
exposures and risks associated with
establishing the tolerance were
discussed in the Notice published in the
Federal Register of June 21, 2006 (71 FR
35664) (FRL–8065–4) which made
available the cumulative risk assessment
for the chlorinated triazine pesticides,
which include atrazine. The Agency
concluded that the cumulative risks
associated with the chlorinated triazine
pesticides are below the Agency’s level
of concern. In the risk assessment for
the inadvertant residues of atrazine on
leafy vegetables, EPA concluded that the
food related exposures to atrazine from
leafy vegetables are insignificant. Thus,
the atrazine-related risks calculated in
the triazine cumulative risk assessment
will be unchanged by this action. The
triazine cumulative risk assessment can
be accessed at https://
www.regulations.gov under docket
identification (ID) number EPA–HQ–
OPP–2005–0481. Based on the risk
assessment discussed in the above
notice, 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 to atrazine residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
(Syngenta Analytical Methods AG–601,
AG–484, AG–564 (plants), Method III in
Pam Vol. II (milk) and Method I in PAM
Vol. II (meat)) 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; e-mail address:
residuemethods@epa.gov.
B. International Residue Limits
The Codex Alimentarius Commission
has not proposed or established
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37851
maximum residue limits (MRLs) for
residues of atrazine in or on agricultural
commodities.
C. Response to Comments
Several comments were received from
a private citizen objecting to pesticide
body load, animal testing, establishing
tolerances, and pesticide residues. The
Agency has received these same
comments from this commenter on
numerous previous occasions. Refer to
the following Federal Register cites: 70
FR 37686, June 30, 2005; 70 FR 1354,
January 7, 2005; 69 FR 63096–63098
October 29, 2004; for the Agency’s
response to these objections.
D. Revisions to Petitioned-For
Tolerances
Based upon review of the data
supporting the petition, EPA has
concluded that a tolerance level of 0.25
ppm on leafy vegetables (excluding
brassica) is more appropriate than 0.60
ppm as it covers the maximum residue
level found in the study submitted,
while retaining the capability of
detecting instances of misuse. The
Agency is revising the raw agricultural
commodities nomenclature for ‘‘leafy
vegetables (excluding brassica)’’ to
‘‘vegetable, leafy, except brassica, group
4.’’
V. Conclusion
Therefore, tolerances are established
for residues of atrazine, 2-chloro-4ethylamino-6-isopropylamino-s-triazine,
in or on vegetable, leafy, except
brassica, group 4 at 0.25 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,
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
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Federal Register / Vol. 73, No. 128 / Wednesday, July 2, 2008 / Rules and Regulations
mstockstill on PROD1PC66 with RULES
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).
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).
VerDate Aug<31>2005
17:12 Jul 01, 2008
Jkt 214001
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 23, 2008.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 180—[AMENDed]
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.220 is amended by
adding text to paragraph (d) to read as
follows:
I
§ 180.220 Atrazine; tolerances for
residues.
*
*
*
*
*
(d) Indirect or inadvertant residues.
Tolerances are established for indirect
or inadvertant residues of atrazine, 2chloro-4-ethylamino-6-isopropylaminos-triazine, in or on the following raw
agricultural commodity when present
therein as a result of application of
atrazine to the growing crops in
paragraph (a) of this section:
applied/used in public eating places,
dairy processing equipment, and/or
food processing equipment and utensils.
Lonza, Inc., submitted a petition to EPA
under the Federal Food, Drug, and
Cosmetic Act (FFDCA), as amended by
the Food Quality Protection Act of 1996
(FQPA), requesting to establish
concentration limits of DDACB in enduse products eligible for the exemption
from the requirement of a tolerance. As
amended, the regulation will exempt
solutions from the requirement of
tolerance residues resulting from
contact with surfaces treated with
solutions where the end-use
concentration of DDACB does not
exceed 240 parts per million (ppm).
DATES: This regulation is effective July
2, 2008. Objections and requests for
hearings must be received on or before
September 2, 2008, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION.
EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2006–1024. To access the
electronic docket, go to https://
www.regulations.gov, select ‘‘Advanced
Search,’’ then ‘‘Docket Search.’’ Insert
the docket ID number where indicated
and select the ‘‘Submit’’ button. Follow
Commodity
Parts per million
the instructions on the regulations.gov
website to view the docket index or
Vegetable, leafy, except
brassica, group 4 ........
0.25 access available documents. All
documents in the docket are listed in
[FR Doc. E8–15010 Filed 7–1–08; 8:45 am]
the docket index available in
regulations.gov. Although listed in the
BILLING CODE 6560–50–S
index, some information is not publicly
available, e.g., Confidential Business
ENVIRONMENTAL PROTECTION
Information (CBI) or other information
AGENCY
whose disclosure is restricted by statute.
Certain other material, such as
40 CFR Part 180
copyrighted material, is not placed on
the Internet and will be publicly
[EPA–HQ–OPP–2006–1024; FRL–8368–1]
available only in hard copy form.
Residues of Quaternany Ammonium
Publicly available docket materials are
Compounds, Didecyl Dimethyl
available either in the electronic docket
Ammonium Carbonate and Didecyl
at https://www.regulations.gov, or, if only
Dimethyl Ammonium Bicarbonate;
available in hard copy, at the Office of
Exemption from the Requirement of a
Pesticide Programs (OPP) Regulatory
Tolerance
Public Docket in Rm. S–4400, One
Potomac Yard (South Bldg.), 2777 S.
AGENCY: Environmental Protection
Crystal Dr., Arlington, VA. The hours of
Agency (EPA).
operation of this Docket Facility are
ACTION: Final rule.
from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal
SUMMARY: This regulation establishes an
holidays. The Docket Facility telephone
exemption from the requirement of a
tolerance for residues of the quaternany number is (703) 305–5805.
ammonium compounds, didecyl
FOR FURTHER INFORMATION CONTACT:
dimethyl ammonium carbonate and
Velma Noble, Antimicrobials Division
didecyl dimethyl ammonium
(7510P), Environmental Protection
bicarbonate (hereinafter cited jointly as
Agency, 1200 Pennsylvania Ave., NW.,
DDACB), on food-contact surfaces when Washington, DC 20460–0001; telephone
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ADDRESSES:
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]]>Agencies
[Federal Register Volume 73, Number 128 (Wednesday, July 2, 2008)]
[Rules and Regulations]
[Pages 37850-37852]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-15010]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-0192; FRL-8364-1]
Atrazine; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
atrazine in or on vegetable, leafy, except brassica, group 4. Syngenta
Crop Protection Inc. requested these tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective July 2, 2008. Objections and
requests for hearings must be received on or before September 2, 2008,
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-2006-0192. To access the
electronic docket, go to https://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 website 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 https://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: Hope Johnson, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-5410; e-mail address: johnson.hope@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 an electronic copy of this Federal
Register document through the electronic docket at https://
www.regulations.gov, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at https://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 https://www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of 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-2006-0192 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 September 2, 2008.
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-2006-0192, by one of the following methods:
Federal eRulemaking Portal: https://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
[[Page 37851]]
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 Facility telephone number is (703) 305-5805.
II. Petition for Tolerance
In the Federal Register of August 15, 2006 (71 FR 46911) (FRL-8064-
1), 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
6F7022) by Syngenta Crop Protection Inc., P.O. Box 18300, Greensboro,
NC 27409. The petition requested that 40 CFR 180.220 be amended by
establishing tolerances for residues of the herbicide atrazine, 2-
chloro-4-ethylamino-6-isopropylamino-s-triazine, in or on leafy
vegetables (excluding brassica) at 0.60 parts per million (ppm). That
notice referenced a summary of the petition prepared by Syngenta Crop
Protection Inc., the registrant, which is available to the public in
the docket, https://www.regulations.gov. Comments were received on the
notice of filing. EPA's response to these comments is discussed in Unit
IV.C.
Based upon review of the data supporting the petition, EPA has
concluded that a tolerance level of 0.25 ppm shall be established for
the raw agricultural commodities vegetable, leafy, except brassica,
group 4. The reason for these changes are explained in Unit IV.D.
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 atrazine on vegetable, leafy, except
brassica, group 4 at 0.25 ppm. EPA's assessment of exposures and risks
associated with establishing the tolerance were discussed in the Notice
published in the Federal Register of June 21, 2006 (71 FR 35664) (FRL-
8065-4) which made available the cumulative risk assessment for the
chlorinated triazine pesticides, which include atrazine. The Agency
concluded that the cumulative risks associated with the chlorinated
triazine pesticides are below the Agency's level of concern. In the
risk assessment for the inadvertant residues of atrazine on leafy
vegetables, EPA concluded that the food related exposures to atrazine
from leafy vegetables are insignificant. Thus, the atrazine-related
risks calculated in the triazine cumulative risk assessment will be
unchanged by this action. The triazine cumulative risk assessment can
be accessed at https://www.regulations.gov under docket identification
(ID) number EPA-HQ-OPP-2005-0481. Based on the risk assessment
discussed in the above notice, 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 to atrazine residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (Syngenta Analytical Methods AG-
601, AG-484, AG-564 (plants), Method III in Pam Vol. II (milk) and
Method I in PAM Vol. II (meat)) 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; e-mail address:
residuemethods@epa.gov.
B. International Residue Limits
The Codex Alimentarius Commission has not proposed or established
maximum residue limits (MRLs) for residues of atrazine in or on
agricultural commodities.
C. Response to Comments
Several comments were received from a private citizen objecting to
pesticide body load, animal testing, establishing tolerances, and
pesticide residues. The Agency has received these same comments from
this commenter on numerous previous occasions. Refer to the following
Federal Register cites: 70 FR 37686, June 30, 2005; 70 FR 1354, January
7, 2005; 69 FR 63096-63098 October 29, 2004; for the Agency's response
to these objections.
D. Revisions to Petitioned-For Tolerances
Based upon review of the data supporting the petition, EPA has
concluded that a tolerance level of 0.25 ppm on leafy vegetables
(excluding brassica) is more appropriate than 0.60 ppm as it covers the
maximum residue level found in the study submitted, while retaining the
capability of detecting instances of misuse. The Agency is revising the
raw agricultural commodities nomenclature for ``leafy vegetables
(excluding brassica)'' to ``vegetable, leafy, except brassica, group
4.''
V. Conclusion
Therefore, tolerances are established for residues of atrazine, 2-
chloro-4-ethylamino-6-isopropylamino-s-triazine, in or on vegetable,
leafy, except brassica, group 4 at 0.25 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, 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
[[Page 37852]]
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).
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 23, 2008.
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 180.220 is amended by adding text to paragraph (d) to read
as follows:
Sec. 180.220 Atrazine; tolerances for residues.
* * * * *
(d) Indirect or inadvertant residues. Tolerances are established
for indirect or inadvertant residues of atrazine, 2-chloro-4-
ethylamino-6-isopropylamino-s-triazine, in or on the following raw
agricultural commodity when present therein as a result of application
of atrazine to the growing crops in paragraph (a) of this section:
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Vegetable, leafy, except brassica, group 4........... 0.25
------------------------------------------------------------------------
[FR Doc. E8-15010 Filed 7-1-08; 8:45 am]
BILLING CODE 6560-50-S
