Aspergillus flavus AF36 on Pistachio; Temporary Exemption From the Requirement of a Tolerance, 28868-28871 [E7-9729]
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28868
Federal Register / Vol. 72, No. 99 / Wednesday, May 23, 2007 / Rules and Regulations
copy of the rule, 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
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cannot take effect until 60 days after it
is published in the Federal Register.
This action is not a ‘‘major rule’’ as
defined by 5 U.S.C. 804(2).
Under section 307(b)(1) of the CAA,
petitions for judicial review of this
action must be filed in the United States
Court of Appeals for the appropriate
circuit by July 23, 2007. Filing a petition
for reconsideration by the Administrator
of this final rule does not affect the
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time within which a petition for judicial
review may be filed, and shall not
postpone the effectiveness of such rule
or action. This action may not be
challenged later in proceedings to
enforce its requirements. (See CAA
section 307(b)(2).)
Dated: May 14, 2007.
Russell L. Wright, Jr.,
Acting Regional Administrator, Region 4.
I
PART 52—[AMENDED]
1. The authority citation for part 52
continues to read as follows:
I
Authority: 42 U.S.C. 7401 et seq.
List of Subjects in 40 CFR Part 52
Environmental protection, Air
pollution control, Intergovernmental
relations, Nitrogen dioxide, Ozone,
Particulate matter, Reporting and
recordkeeping requirements, Volatile
organic compounds.
40 CFR part 52 is amended as follows:
Subpart L—Georgia
2. Section 52.570(e) is amended by
revising an entry at the end of the table
for ‘‘Douglas County, GA’’ to read as
follows:
I
§ 52.570
*
Identification of plan.
*
*
(e) * * *
*
*
EPA APPROVED GEORGIA NONREGULATORY PROVISIONS
Name of nonregulatory SIP provision
Applicable geographic or
nonattainment area
24. Alternative Fuel Refueling Station/Park and Ride Transportation
Center, Project DO–AR–211 is removed.
Douglas County, GA ...................
[FR Doc. E7–9909 Filed 5–22–07; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2007–0158; FRL–8129–4]
Aspergillus flavus AF36 on Pistachio;
Temporary Exemption From the
Requirement of a Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
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AGENCY:
SUMMARY: This regulation establishes a
temporary exemption from the
requirement of a tolerance for residues
of Aspergillus flavus AF36 on pistachio
when applied/used to reduce aflatoxinproducing Aspergillus flavus.
Interregional Research Project Number 4
(IR-4), Rutgers University, 500 College
Road East, Suite 201W, Princeton, NJ
08540 on behalf of the Arizona Cotton
Research and Protection Council], 3721
East Wier Avenue Phoenix, Arizona
85040-2933 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 the temporary
tolerance exemption. This regulation
eliminates the need to establish a
maximum permissible level for residues
VerDate Aug<31>2005
15:35 May 22, 2007
Jkt 211001
of Aspergillus flavus AF36. The
temporary tolerance exemption expires
on May 14, 2010.
DATES: This regulation is effective May
23, 2007. Objections and requests for
hearings must be received on or before
June 22, 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–2007–0158. 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
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
https://www.regulations.gov, or, if only
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State submittal
date/effective
date
EPA approval date
09/19/06
5/23/07, [Insert citation of publication].
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:
Shanaz Bacchus, Biopesticides and
Pollution Prevention Division (7511P),
Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460-0001; telephone number:
(703) 308-8097; e-mail address:
bacchus.shanaz@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:
• 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 provides a guide
for readers regarding entities likely to be
E:\FR\FM\23MYR1.SGM
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Federal Register / Vol. 72, No. 99 / Wednesday, May 23, 2007 / Rules and Regulations
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. To determine whether
you or your business may be affected by
this action, you should carefully
examine the applicability provisions in
Section 5 of FIFRA and the regulations
promulgated to carry out that provision
of FIFRA (40 CFR part 172). 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 40 CFR part 180
through the Government Printing
Office’s pilot e-CFR site at https://
www.gpoaccess.gov/ecfr.
cprice-sewell on PROD1PC71 with RULES
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of the FFDCA, as
amended by the FQPA, any person may
file an objection to any aspect of this
regulation and may also request a
hearing on those objections. The EPA
procedural regulations which govern the
submission of objections and requests
for hearings appear in 40 CFR part 178.
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–2007–0158 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
on or before July 23, 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 your
copies, identified by docket ID number
VerDate Aug<31>2005
15:35 May 22, 2007
Jkt 211001
EPA–HQ–OPP–2007–0158, 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
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. Background and Statutory Findings
In the Federal Register of March 21,
2007 (72 FR 13277) (FRL–8117–4), EPA
issued a notice pursuant to section
408(d)(3) of the FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide tolerance petition (PP 6E7118)
by Interregional Research Project
Number 4 (IR-4), Rutgers University,
500 College Road East, Suite 201W,
Princeton, NJ 08540 on behalf of the
Arizona Cotton Research and Protection
Council, 3721 E. Wier Ave., Phoenix,
AZ 85040–2933. The petition requested
that 40 CFR part 180 be amended by
establishing a temporary exemption
from the requirement of a tolerance for
residues of Aspergillus flavus AF36 on
pistachio. This notice included a
summary of the petition prepared by the
petitioner IR-4, on behalf of the Arizona
Cotton Research and Protection Council.
One comment received in response to
the notice of filing suggested that the
area should be notified of the proposed
application of the pesticide. In this
respect, a Federal Register Notice of the
receipt of the application for the
Experimental Use Permit was published
in the Federal Register on March 9,
2007 (72 FR–10751) (FRL–8117–6).
Another announcement, regarding the
filing of the pesticide petition discussed
herein, was published in the Federal
Register on March 21, 2007 (72 FR
13277) (FRL–8117–4).
Section 408(c)(2)(A)(i) of the FFDCA
allows EPA to establish an exemption
from the requirement for a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the exemption is ‘‘safe.’’
Section 408(c)(2)(A)(ii) of the FFDCA
defines ‘‘safe ’’ to mean that ‘‘there is a
reasonable certainty that no harm will
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28869
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. Pursuant to
section 408(c)(2)(B), in establishing or
maintaining in effect an exemption from
the requirement of a tolerance, EPA
must take into account the factors set
forth in section 408(b)(2)(C), which
require 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. * * *’’ Additionally, section
408(b)(2)(D) of the FFDCA requires that
the Agency consider ‘‘available
information concerning the cumulative
effects of a particular pesticide’s
residues’’ and ‘‘other substances that
have a common mechanism of toxicity.’’
EPA performs a number of analyses to
determine the risks from aggregate
exposure to pesticide residues. First,
EPA determines the toxicity of
pesticides. Second, EPA examines
exposure to the pesticide through food,
drinking water, and through other
exposures that occur as a result of
pesticide use in residential settings.
III. Toxicological Profile
Consistent with section 408(b)(2)(D)
of the FFDCA, EPA has reviewed the
available scientific data and other
relevant information in support of this
action and considered its validity,
completeness and reliability and the
relationship of this information to
human risk. EPA has also considered
available information concerning the
variability of the sensitivities of major
identifiable subgroups of consumers,
including infants and children.
The toxicological profile of the
conditionally registered microbial
pesticide, Aspergillus flavus AF36 has
been previously described in the final
rule of the Federal Register of July 14,
2003 (68 FR 41535) (FRL–7311–6). The
exemption from tolerance of Aspergillus
flavus AF36, a non-aflatoxin-producing
strain of Aspergillus flavus, on cotton
was established in 40 CFR §180.1206.
The database supporting that exemption
from tolerance also supports the
proposed temporary exemption of this
active ingredient on pistachio. The
pesticide was neither toxic nor infective
via the oral and pulmonary routes. It
was placed in Toxicity Category IV for
acute oral effects. The Toxicity Category
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Federal Register / Vol. 72, No. 99 / Wednesday, May 23, 2007 / Rules and Regulations
III designation for acute inhalation
effects is based on the granular nature
of the pesticide and the submitted
pulmonary studies. This pesticide has
been used for more than a decade in
experimental laboratory and field trials
and in agricultural practice on cotton in
Arizona, Texas and California without
any reports of adverse dermal irritation
or hypersensitivity effects.
The petitioner now seeks to amend
that exemption from tolerance of
Aspergillus flavus AF36 on cotton, to
include a temporary exemption from
tolerance for residues of the fungal
active ingredient on pistachio. An
Experimental Use Permit, EPA
Registration Number 71693-EUP-1, is
proposed for three years to treat 3,000
acre pistachio trees per year by ground
application. Treatment of a total of
9,000 acres over three years in 2007,
2008, and 2009, will utilize a total of
approximately 0.72 pound of the active
ingredient, Aspergillus flavus AF36. No
further toxicological data are required
for this temporary exemption from the
requirement of a tolerance for
Aspergillus flavus AF36 on pistachio.
IV. Aggregate Exposures
In examining aggregate exposure,
section 408 of the FFDCA directs EPA
to consider available information
concerning exposures from the pesticide
residue in food and all other nonoccupational exposures, including
drinking water from ground water or
surface water and exposure through
pesticide use in gardens, lawns, or
buildings (residential and other indoor
uses).
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A. Dietary Exposure
1. Food. The aforesaid final rule for
the exemption from tolerance for
residues of Aspergillus flavus AF 36 on
cotton considered all studies submitted
by the applicant and found them to be
acceptable. Roasting of pistachio nuts
and other post harvest agricultural
practices, such as treatment with
phosphine, are expected to further
reduce any aflatoxin contamination of
pistachio nuts.
2. Drinking water exposure. Those
data are also acceptable to demonstrate
that the proposed use of Aspergillus
flavus AF36 on pistachio will not harm
the U.S adult, infant and children
population from dietary exposure,
including food, and drinking water.
Percolation through the soil and
municipal treatment of drinking water
are expected to preclude exposure of the
U.S population, infants and children to
residues of the pesticide.
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15:35 May 22, 2007
Jkt 211001
B. Other Non-Occupational Exposure
1. Dermal exposure. Dermal nonoccupational exposure is expected to be
minimal to non-existent for the
proposed use of Aspergillus flavus AF36
on pistachio. The pesticide is to be
applied to agricultural sites not in the
proximity of residential areas, schools,
nursing homes or daycares.
2. Inhalation exposure. For the same
reasons non-occupational inhalation
exposure to AF36 is expected to be
minimal to non-existent.
V. Cumulative Effects
Another non-aflatoxin-producing
strain of Aspergillus flavus, NRRL 21882
is registered, but not for use on
pistachio. Cumulative effects of these
strains are not expected to exceed the
risk cup for the registered Aspergillus
flavus strains, AF36 and NRRL 21882.
Furthermore, these strains are expected
to decrease the presence of aflatoxinproducing colonies of the fungus on
treated commodities and thus decrease
the risks posed by the potent liver
carcinogen, aflatoxin.
VI. Determination of Safety for U.S.
Population, Infants and Children
Based on the previously evaluated
data, it is not necessary to use a safety
factor to determine safety to children 9
(see Federal Register, July 14, 2003, as
cited in Unit III.)
VII. Other Considerations
A. Endocrine Disruptors
See Federal Register, July 14, 2003,
cited in Unit III.
B. Analytical Method(s)
See Federal Register, July 14, 2003,
cited in Unit III.
C. Codex Maximum Residue Level
There is no Codex Maximum Residue
Level (MRL) for residues of Aspergillus
flavus AF36 on pistachio.
VIII. 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
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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)
(Pub. L. 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), Pub. L. 104-113, section 12(d)
(15 U.S.C. 272 note).
IX. 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
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Federal Register / Vol. 72, No. 99 / Wednesday, May 23, 2007 / Rules and Regulations
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: May 14, 2007.
Janet L. Andersen,
Director, Biopesticides and Pollution
Prevention 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 180.1206 is amended by
designating the existing text as
paragraph (a) and by adding paragraph
(b) to read as follows:
I
§ 180.1206 Aspergillus flavus AF36 on
pistachio; exemption from the requirement
of a tolerance.
(a) * * *
(b) Apergillus flavus AF36 is
temporarily exempt from the
requirement of a tolerance on pistachio
when used in accordance with the
Experimental Use Permit 71693-EUP-1.
This temporary exemption from
tolerance will expire on May 14, 2010.
[FR Doc. E7–9729 Filed 5–22–07; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
Barbara Madden, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460-0001; telephone number:
(703) 305-6463; e-mail
address:madden.barbara@epa.gov.
A. Does this Action Apply to Me?
Coumaphos; Pesticide Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
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FOR FURTHER INFORMATION CONTACT:
I. General Information
[EPA–HQ–OPP–2006–0820; FRL–8131–4]
SUMMARY: This regulation establishes
tolerances for residues of coumaphos in
or on honey and honeycomb.
Interregional Research Project #4 (IR-4)
requested these tolerances under the
Federal Food, Drug, and Cosmetic Act
(FFDCA).
17:09 May 22, 2007
EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2006–0820. 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
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
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.
ADDRESSES:
SUPPLEMENTARY INFORMATION:
40 CFR Part 180
VerDate Aug<31>2005
This regulation is effective May
23, 2007. Objections and requests for
hearings must be received on or before
July 23, 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).
DATES:
Jkt 211001
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.
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28871
• Animal production (NAICS code
112), e.g., cattle ranchers and farmers,
dairy cattle farmers, livestock farmers.
• Food manufacturing (NAICS code
311), e.g., agricultural workers; farmers;
greenhouse, nursery, and floriculture
workers; ranchers; pesticide applicators.
• Pesticide manufacturing (NAICS
code 32532), e.g., agricultural workers;
commercial applicators; farmers;
greenhouse, nursery, and floriculture
workers; residential users.
This listing is not intended to be
exhaustive, but rather to provide a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Access Electronic Copies
of this Document?
In addition to accessing an electronic
copy of this Federal Register document
through the electronic docket at 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 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–2006–0820 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 23, 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
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]]>Agencies
[Federal Register Volume 72, Number 99 (Wednesday, May 23, 2007)]
[Rules and Regulations]
[Pages 28868-28871]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-9729]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2007-0158; FRL-8129-4]
Aspergillus flavus AF36 on Pistachio; Temporary Exemption From
the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a temporary exemption from the
requirement of a tolerance for residues of Aspergillus flavus AF36 on
pistachio when applied/used to reduce aflatoxin-producing Aspergillus
flavus. Interregional Research Project Number 4 (IR-4), Rutgers
University, 500 College Road East, Suite 201W, Princeton, NJ 08540 on
behalf of the Arizona Cotton Research and Protection Council], 3721
East Wier Avenue Phoenix, Arizona 85040-2933 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 the
temporary tolerance exemption. This regulation eliminates the need to
establish a maximum permissible level for residues of Aspergillus
flavus AF36. The temporary tolerance exemption expires on May 14, 2010.
DATES: This regulation is effective May 23, 2007. Objections and
requests for hearings must be received on or before June 22, 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-2007-0158. 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 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 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: Shanaz Bacchus, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 308-8097; e-mail
address: bacchus.shanaz@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:
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 provides
a guide for readers regarding entities likely to be
[[Page 28869]]
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. To determine whether you or your business may be affected by
this action, you should carefully examine the applicability provisions
in Section 5 of FIFRA and the regulations promulgated to carry out that
provision of FIFRA (40 CFR part 172). 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 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 the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. 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-2007-0158 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 on or
before July 23, 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 your copies, identified by docket ID
number EPA-HQ-OPP-2007-0158, 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 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. Background and Statutory Findings
In the Federal Register of March 21, 2007 (72 FR 13277) (FRL-8117-
4), EPA issued a notice pursuant to section 408(d)(3) of the FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 6E7118) by Interregional Research Project Number 4 (IR-4),
Rutgers University, 500 College Road East, Suite 201W, Princeton, NJ
08540 on behalf of the Arizona Cotton Research and Protection Council,
3721 E. Wier Ave., Phoenix, AZ 85040-2933. The petition requested that
40 CFR part 180 be amended by establishing a temporary exemption from
the requirement of a tolerance for residues of Aspergillus flavus AF36
on pistachio. This notice included a summary of the petition prepared
by the petitioner IR-4, on behalf of the Arizona Cotton Research and
Protection Council. One comment received in response to the notice of
filing suggested that the area should be notified of the proposed
application of the pesticide. In this respect, a Federal Register
Notice of the receipt of the application for the Experimental Use
Permit was published in the Federal Register on March 9, 2007 (72 FR-
10751) (FRL-8117-6). Another announcement, regarding the filing of the
pesticide petition discussed herein, was published in the Federal
Register on March 21, 2007 (72 FR 13277) (FRL-8117-4).
Section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(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. Pursuant to section 408(c)(2)(B), in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
section 408(b)(2)(C), which require 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. * * *''
Additionally, section 408(b)(2)(D) of the FFDCA requires that the
Agency consider ``available information concerning the cumulative
effects of a particular pesticide's residues'' and ``other substances
that have a common mechanism of toxicity.''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.
III. Toxicological Profile
Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed
the available scientific data and other relevant information in support
of this action and considered its validity, completeness and
reliability and the relationship of this information to human risk. EPA
has also considered available information concerning the variability of
the sensitivities of major identifiable subgroups of consumers,
including infants and children.
The toxicological profile of the conditionally registered microbial
pesticide, Aspergillus flavus AF36 has been previously described in the
final rule of the Federal Register of July 14, 2003 (68 FR 41535) (FRL-
7311-6). The exemption from tolerance of Aspergillus flavus AF36, a
non-aflatoxin-producing strain of Aspergillus flavus, on cotton was
established in 40 CFR Sec. 180.1206. The database supporting that
exemption from tolerance also supports the proposed temporary exemption
of this active ingredient on pistachio. The pesticide was neither toxic
nor infective via the oral and pulmonary routes. It was placed in
Toxicity Category IV for acute oral effects. The Toxicity Category
[[Page 28870]]
III designation for acute inhalation effects is based on the granular
nature of the pesticide and the submitted pulmonary studies. This
pesticide has been used for more than a decade in experimental
laboratory and field trials and in agricultural practice on cotton in
Arizona, Texas and California without any reports of adverse dermal
irritation or hypersensitivity effects.
The petitioner now seeks to amend that exemption from tolerance of
Aspergillus flavus AF36 on cotton, to include a temporary exemption
from tolerance for residues of the fungal active ingredient on
pistachio. An Experimental Use Permit, EPA Registration Number 71693-
EUP-1, is proposed for three years to treat 3,000 acre pistachio trees
per year by ground application. Treatment of a total of 9,000 acres
over three years in 2007, 2008, and 2009, will utilize a total of
approximately 0.72 pound of the active ingredient, Aspergillus flavus
AF36. No further toxicological data are required for this temporary
exemption from the requirement of a tolerance for Aspergillus flavus
AF36 on pistachio.
IV. Aggregate Exposures
In examining aggregate exposure, section 408 of the FFDCA directs
EPA to consider available information concerning exposures from the
pesticide residue in food and all other non-occupational exposures,
including drinking water from ground water or surface water and
exposure through pesticide use in gardens, lawns, or buildings
(residential and other indoor uses).
A. Dietary Exposure
1. Food. The aforesaid final rule for the exemption from tolerance
for residues of Aspergillus flavus AF 36 on cotton considered all
studies submitted by the applicant and found them to be acceptable.
Roasting of pistachio nuts and other post harvest agricultural
practices, such as treatment with phosphine, are expected to further
reduce any aflatoxin contamination of pistachio nuts.
2. Drinking water exposure. Those data are also acceptable to
demonstrate that the proposed use of Aspergillus flavus AF36 on
pistachio will not harm the U.S adult, infant and children population
from dietary exposure, including food, and drinking water. Percolation
through the soil and municipal treatment of drinking water are expected
to preclude exposure of the U.S population, infants and children to
residues of the pesticide.
B. Other Non-Occupational Exposure
1. Dermal exposure. Dermal non-occupational exposure is expected to
be minimal to non-existent for the proposed use of Aspergillus flavus
AF36 on pistachio. The pesticide is to be applied to agricultural sites
not in the proximity of residential areas, schools, nursing homes or
daycares.
2. Inhalation exposure. For the same reasons non-occupational
inhalation exposure to AF36 is expected to be minimal to non-existent.
V. Cumulative Effects
Another non-aflatoxin-producing strain of Aspergillus flavus, NRRL
21882 is registered, but not for use on pistachio. Cumulative effects
of these strains are not expected to exceed the risk cup for the
registered Aspergillus flavus strains, AF36 and NRRL 21882.
Furthermore, these strains are expected to decrease the presence of
aflatoxin-producing colonies of the fungus on treated commodities and
thus decrease the risks posed by the potent liver carcinogen,
aflatoxin.
VI. Determination of Safety for U.S. Population, Infants and Children
Based on the previously evaluated data, it is not necessary to use
a safety factor to determine safety to children 9 (see Federal
Register, July 14, 2003, as cited in Unit III.)
VII. Other Considerations
A. Endocrine Disruptors
See Federal Register, July 14, 2003, cited in Unit III.
B. Analytical Method(s)
See Federal Register, July 14, 2003, cited in Unit III.
C. Codex Maximum Residue Level
There is no Codex Maximum Residue Level (MRL) for residues of
Aspergillus flavus AF36 on pistachio.
VIII. 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) (Pub. L.
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), Pub. L. 104-113, section 12(d) (15 U.S.C. 272
note).
IX. 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
[[Page 28871]]
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: May 14, 2007.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention 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 180.1206 is amended by designating the existing text as
paragraph (a) and by adding paragraph (b) to read as follows:
Sec. 180.1206 Aspergillus flavus AF36 on pistachio; exemption from
the requirement of a tolerance.
(a) * * *
(b) Apergillus flavus AF36 is temporarily exempt from the
requirement of a tolerance on pistachio when used in accordance with
the Experimental Use Permit 71693-EUP-1. This temporary exemption from
tolerance will expire on May 14, 2010.
[FR Doc. E7-9729 Filed 5-22-07; 8:45 am]
BILLING CODE 6560-50-S
