Aspergillus flavus AF36 on Pistachio; Extension of Temporary Exemption From the Requirement of a Tolerance, 26543-26546 [E9-12788]
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Federal Register / Vol. 74, No. 105 / Wednesday, June 3, 2009 / Rules and Regulations
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: May 22, 2009.
Daniel J. Rosenblatt,
Acting 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.
Section 180.476 is amended by
revising the introductory text for
paragraph (a)(1); by alphabetically
adding the following commodities to the
■
26543
table in paragraph (a)(1); by revising the
introductory text for paragraph (a)(2);
and by removing the entries for
Broccoli; Collards; Coriander, leaves;
Dandelion, leaves; Kale; Mustard,
greens; Parsley, leaves; Swiss chard; and
Turnip, greens from the table in
paragraph (b) to read as follows:
§ 180.476
residues
Triflumizole; tolerances for
(a) General. (1) Tolerances are
established for residues of the fungicide
triflumizole, including its metabolites
and degradates, in or on the
commodities listed in the table below.
Compliance with the tolerance levels
specified below is to be determined by
measuring only the parent compound
triflumizole, 1-(1-((4-chloro-2(trifluoromethyl)phenyl)imino)-2propoxyethyl )-1 H -imidazole, and its
metabolites containing the 4-chloro-2trifluoromethylaniline moiety,
calculated as stoichiometric equivalent
of the parent compound.
Commodity
Parts per million
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Brassica, head and stem, subgroup 5A ..............................................................................................................................
Brassica, leafy greens, subgroup 5B ..................................................................................................................................
Canistel ................................................................................................................................................................................
*
*
*
*
*
Cilantro, leaves ....................................................................................................................................................................
*
*
*
*
*
Hop, dried cones .................................................................................................................................................................
Leafy greens subgroup 4A, except spinach ........................................................................................................................
Mango ..................................................................................................................................................................................
Papaya .................................................................................................................................................................................
*
*
*
*
*
Pineapple .............................................................................................................................................................................
Sapodilla ..............................................................................................................................................................................
Sapote, black .......................................................................................................................................................................
Sapote, mamey ....................................................................................................................................................................
Star apple ............................................................................................................................................................................
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Swiss chard .........................................................................................................................................................................
Turnip, greens ......................................................................................................................................................................
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(2) Tolerances are established for
residues of the fungicide triflumizole,
including its metabolites and
degradates, in or on the commodities of
animal origin listed in the table below.
Compliance with the tolerance levels
specified below is to be determined by
measuring only the parent compound
triflumizole, 1-(1-((4-chloro-2(trifluoromethyl)phenyl)imino)-2propoxyethyl )-1 H -imidazole, the
metabolite 4-chloro-2-hydroxy-6trifluoromethylaniline sulfate, and other
metabolites containing the 4-chloro-2-
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trifluoromethylaniline moiety,
calculated as the parent compound.
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[FR Doc. E9–12949 Filed 6–2–09; 8:45 am]
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40
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2007–0158; FRL–8416–7]
BILLING CODE 6560–50–S
PO 00000
8.0
40
2.5
Aspergillus flavus AF36 on Pistachio;
Extension of Temporary Exemption
From the Requirement of a Tolerance
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation amends the
temporary exemption from the
requirement of a tolerance for residues
of the Aspergillus flavus AF36 (A. flavus
AF36) on pistachio when applied/used
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Federal Register / Vol. 74, No. 105 / Wednesday, June 3, 2009 / Rules and Regulations
as an antifungal agent to displace
aflatoxin-producing fungi. Interregional
Research Project Number 4 (IR-4), on
behalf of the Arizona Cotton Research
and Protection Council, submitted a
petition to EPA under the Federal Food,
Drug, and Cosmetic Act (FFDCA),
requesting the temporary tolerance
exemption be amended. The
amendment extends the expiration date
to December 31, 2011.
DATES: This regulation is effective June
3, 2009. Objections and requests for
hearings must be received on or before
August 3, 2009, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2007–0158. All documents in the
docket are listed in the docket index
available at https://www.regulations.gov.
Although listed in the index, some
information is not publicly available,
e.g., Confidential Business Information
(CBI) or other information whose
disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available in the electronic docket at
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.
ADDRESSES:
SUPPLEMENTARY INFORMATION:
I. General Information
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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).
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• 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
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Access Electronic Copies
of this Document?
In addition to accessing electronically
available documents at 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 e-CFR site at https://
www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of FFDCA, 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
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 August 3, 2009.
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing that does not
contain any CBI for inclusion in the
public docket that is described in
ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit your
copies, identified by docket ID number
PO 00000
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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
Facility’s normal hours of operation
(8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays).
Special arrangements should be made
for deliveries of boxed information. The
Docket Facility telephone number is
(703) 305–5805.
II. Background and Statutory Findings
In the Federal Register of March 16,
2009 (74 FR 11100) (FRL–8405–1), 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 tolerance petition (PP 8E7461)
by 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 Weir Ave., Phoenix, AZ 85040–
2933. The petition proposes to amend a
temporary exemption from the
requirement of a tolerance in 40 CFR
180.1206(b) for residues of the nonaflatoxin-producing microbial
antifungal agent, A. flavus AF36, in or
on pistachio.
This docket included a summary of
the petition prepared by the petitioner
IR-4 and Arizona Cotton Research and
Protection Council. There were no
comments received in response to the
notice of filing.
Section 408(c)(2)(A)(i) of 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 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) of FFDCA, in
establishing or maintaining in effect an
exemption from the requirement of a
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tolerance, EPA must take into account
the factors set forth in section
408(b)(2)(C) of FFDCA, 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
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 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
microbial pesticide, A. flavus AF36 has
been previously described in the final
rule of the Federal Register issue of July
14, 2003 (68 FR 41535) (FRL–7311–6).
The exemption from tolerance of A.
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
temporary exemption of this active
ingredient on pistachio in 40 CFR
180.1206(b). See the Federal Register
issue of May 23, 2007 (72 FR 28868)
(FRL–8129–4).
The microbial 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 III
designation for acute inhalation effects
is based on the granular nature of the
microbial pesticide and the submitted
pulmonary studies. This microbial
pesticide has been used for more than
a decade in experimental laboratory and
field trials and in agricultural practice
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on cotton in Arizona, California, and
Texas without any reports of adverse
dermal irritation or hypersensitivity
effects.
The petitioner now seeks to amend
the temporary exemption from the
requirement of a tolerance for A. flavus
AF36 on pistachio in accordance with
the Experimental Use Permit (EUP),
EPA File Symbol 71693–EUP–1,
published in the Federal Register issue
of May 23, 2007 (72 FR 28971) (FRL–
8128–8) and to extend it to December
31, 2011.
No further toxicological data are
required for this amended temporary
exemption from the requirement of a
tolerance for A. flavus AF36 on
pistachio.
IV. Aggregate Exposures
In examining aggregate exposure,
section 408 of 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).
For aggregate dietary and other nonoccupational exposure and cumulative
effects, the Agency continues to rely on
its previous assessments published in
the Federal Register, since the
extension will not change these
exposures and risks. See the previously
published July 14, 2003 and May 23,
2007 Federal Register documents cited
in Unit III.
V. Determination of Safety for U.S.
Population, Infants and Children
The Agency also relies on the
previous assessments published in the
July 14, 2003 and May 23, 2007 Federal
Register documents cited in Unit III. to
determine that there is reasonable
certainty that no harm will result from
aggregate exposures to residues of the
antifungal agent A. flavus AF36.
Because there are no threshold effects of
concern to infants, children and adults
when A. flavus AF36 is used as labeled,
the provision requiring an additional
margin of safety does not apply. As a
result, EPA has not used a margin of
exposure (safety) approach to assess the
safety of A. flavus AF36.
VI. Other Considerations
A. Analytical Methods and Endocrine
Disruptors
The Agency continues to rely on its
assessment for endocrine disruptors and
analytical methods in the previously
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26545
published July 14, 2003 Federal
Register document cited in Unit III.
B. Codex Maximum Residue Level
There is no Codex Maximum Residue
Level (MRL) for residues of A. flavus
AF36 on pistachio.
VII. Statutory and Executive Order
Reviews
This final rule establishes a tolerance
or exemption from 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 final rule
has been exempted from review under
Executive Order 12866, this final rule is
not subject to Executive Order 13211,
entitled Actions Concerning Regulations
That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001) or Executive Order 13045,
entitled Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997).
This final rule does not contain any
information collections subject to OMB
approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et
seq., nor does it require any special
considerations under Executive Order
12898, entitled Federal Actions to
Address Environmental Justice in
Minority Populations and Low-Income
Populations (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under section 408(d) of FFDCA, such as
the temporary tolerance exemption 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
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Federal Register / Vol. 74, No. 105 / Wednesday, June 3, 2009 / Rules and Regulations
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).
VIII. 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: May 20, 2009.
W. Michael McDavit,
Acting Director, Biopesticides and Pollution
Prevention Division, Office of Pesticide
Programs.
Therefore, 40 CFR chapter I is
amended as follows:
■
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.1206(b) is revised to
read as follows:
dwashington3 on PROD1PC60 with RULES
■
§ 180.1206 Aspergillus flavus AF36,
exemption from the requirement of a
tolerance.
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(b) Aspergillus flavus AF36 is
temporarily exempt from the
requirement of a tolerance on pistachio
when used in accordance with the
Experimental Use Permit, EPA File
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Symbol 71693–EUP–1. This temporary
exemption from tolerance expires on
December 31, 2011.
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[FR Doc. E9–12788 Filed 6–2–09; 8:45 am]
BILLING CODE 6560–50–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Part 412
[CMS–1337–IFC]
RIN 0938–AP76
Medicare Program; Revisions to FY
2009 Medicare Severity-Long-Term
Care Diagnosis-Related Group (MS–
LTC–DRG) Weights
AGENCY: Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Interim final rule with comment
period.
SUMMARY: This interim final rule with
comment period implements revised
Medicare severity long-term care
diagnosis-related group (MS–LTC–DRG)
relative weights for payment under the
long-term care hospital (LTCH)
prospective payment system (PPS) for
federal fiscal year (FY) 2009. We are
revising the MS–LTC–DRG relative
weights for FY 2009 due to the
misapplication of our established
methodology in the calculation of the
budget neutrality factor. The revised FY
2009 MS–LTC–DRG relative weights are
effective for the remainder of FY 2009
(that is, from June 3, 2009 through
September 30, 2009).
DATES: Effective date: These regulations
are effective on June 3, 2009.
Comment date: To be assured
consideration, comments must be
received at one of the addresses
provided below, no later than 5 p.m.,
June 29, 2009.
ADDRESSES: In commenting, please refer
to file code CMS–1337–IFC. Because of
staff and resource limitations, we cannot
accept comments by facsimile (FAX)
transmission.
You may submit comments in one of
four ways (please choose only one of the
ways listed):
1. Electronically. You may submit
electronic comments on this regulation
to https://www.regulations.gov. Follow
the instructions under the ‘‘More Search
Options’’ tab.
2. By regular mail. You may mail
written comments to the following
PO 00000
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address ONLY: Centers for Medicare &
Medicaid Services, Department of
Health and Human Services, Attention:
CMS–1337–IFC, P.O. Box 8011,
Baltimore, MD 21244–8011.
Please allow sufficient time for mailed
comments to be received before the
close of the comment period.
3. By express or overnight mail. You
may send written comments to the
following address only: Centers for
Medicare & Medicaid Services,
Department of Health and Human
Services, Attention: CMS–1337–IFC,
Mail Stop C4–26–05, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
4. By hand or courier. If you prefer,
you may deliver (by hand or courier)
your written comments before the close
of the comment period to either of the
following addresses:
a. For delivery in Washington, DC—
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, Room 445–G, Hubert
H. Humphrey Building, 200
Independence Avenue, SW.,
Washington, DC 20201.
(Because access to the interior of the
Hubert H. Humphrey Building is not
readily available to persons without
Federal government identification,
commenters are encouraged to leave
their comments in the CMS drop slots
located in the main lobby of the
building. A stamp-in clock is available
for persons wishing to retain a proof of
filing by stamping in and retaining an
extra copy of the comments being filed.)
b. For delivery in Baltimore, MD—
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
If you intend to deliver your
comments to the Baltimore address,
please call telephone number (410) 786–
9994 in advance to schedule your
arrival with one of our staff members.
Comments mailed to the addresses
indicated as appropriate for hand or
courier delivery may be delayed and
received after the comment period has
ended.
For information on viewing public
comments, see the beginning of the
SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Tzvi
Hefter, (410) 786–4487.
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All
comments received before the close of
the comment period are available for
viewing by the public, including any
personally identifiable or confidential
business information that is included in
a comment. We post all comments
received before the close of the
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]]>Agencies
[Federal Register Volume 74, Number 105 (Wednesday, June 3, 2009)]
[Rules and Regulations]
[Pages 26543-26546]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-12788]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2007-0158; FRL-8416-7]
Aspergillus flavus AF36 on Pistachio; Extension of Temporary
Exemption From the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation amends the temporary exemption from the
requirement of a tolerance for residues of the Aspergillus flavus AF36
(A. flavus AF36) on pistachio when applied/used
[[Page 26544]]
as an antifungal agent to displace aflatoxin-producing fungi.
Interregional Research Project Number 4 (IR-4), on behalf of the
Arizona Cotton Research and Protection Council, submitted a petition to
EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting
the temporary tolerance exemption be amended. The amendment extends the
expiration date to December 31, 2011.
DATES: This regulation is effective June 3, 2009. Objections and
requests for hearings must be received on or before August 3, 2009, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2007-0158. All documents in the
docket are listed in the docket index available at https://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at 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 affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Access Electronic Copies of this Document?
In addition to accessing electronically available documents at
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 e-CFR site at https://www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file
an objection to any aspect of this regulation 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 August 3, 2009.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit 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 Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of March 16, 2009 (74 FR 11100) (FRL-8405-
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 tolerance
petition (PP 8E7461) by 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 Weir Ave., Phoenix, AZ
85040-2933. The petition proposes to amend a temporary exemption from
the requirement of a tolerance in 40 CFR 180.1206(b) for residues of
the non-aflatoxin-producing microbial antifungal agent, A. flavus AF36,
in or on pistachio.
This docket included a summary of the petition prepared by the
petitioner IR-4 and Arizona Cotton Research and Protection Council.
There were no comments received in response to the notice of filing.
Section 408(c)(2)(A)(i) of 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 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) of FFDCA, in
establishing or maintaining in effect an exemption from the requirement
of a
[[Page 26545]]
tolerance, EPA must take into account the factors set forth in section
408(b)(2)(C) of FFDCA, 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 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 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 microbial pesticide, A. flavus
AF36 has been previously described in the final rule of the Federal
Register issue of July 14, 2003 (68 FR 41535) (FRL-7311-6). The
exemption from tolerance of A. 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 temporary exemption of this active ingredient on pistachio
in 40 CFR 180.1206(b). See the Federal Register issue of May 23, 2007
(72 FR 28868) (FRL-8129-4).
The microbial 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 III designation for acute
inhalation effects is based on the granular nature of the microbial
pesticide and the submitted pulmonary studies. This microbial pesticide
has been used for more than a decade in experimental laboratory and
field trials and in agricultural practice on cotton in Arizona,
California, and Texas without any reports of adverse dermal irritation
or hypersensitivity effects.
The petitioner now seeks to amend the temporary exemption from the
requirement of a tolerance for A. flavus AF36 on pistachio in
accordance with the Experimental Use Permit (EUP), EPA File Symbol
71693-EUP-1, published in the Federal Register issue of May 23, 2007
(72 FR 28971) (FRL-8128-8) and to extend it to December 31, 2011.
No further toxicological data are required for this amended
temporary exemption from the requirement of a tolerance for A. flavus
AF36 on pistachio.
IV. Aggregate Exposures
In examining aggregate exposure, section 408 of 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).
For aggregate dietary and other non-occupational exposure and
cumulative effects, the Agency continues to rely on its previous
assessments published in the Federal Register, since the extension will
not change these exposures and risks. See the previously published July
14, 2003 and May 23, 2007 Federal Register documents cited in Unit III.
V. Determination of Safety for U.S. Population, Infants and Children
The Agency also relies on the previous assessments published in the
July 14, 2003 and May 23, 2007 Federal Register documents cited in Unit
III. to determine that there is reasonable certainty that no harm will
result from aggregate exposures to residues of the antifungal agent A.
flavus AF36. Because there are no threshold effects of concern to
infants, children and adults when A. flavus AF36 is used as labeled,
the provision requiring an additional margin of safety does not apply.
As a result, EPA has not used a margin of exposure (safety) approach to
assess the safety of A. flavus AF36.
VI. Other Considerations
A. Analytical Methods and Endocrine Disruptors
The Agency continues to rely on its assessment for endocrine
disruptors and analytical methods in the previously published July 14,
2003 Federal Register document cited in Unit III.
B. Codex Maximum Residue Level
There is no Codex Maximum Residue Level (MRL) for residues of A.
flavus AF36 on pistachio.
VII. Statutory and Executive Order Reviews
This final rule establishes a tolerance or exemption from 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 final rule has been exempted from review under
Executive Order 12866, this final rule is not subject to Executive
Order 13211, entitled Actions Concerning Regulations That Significantly
Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001)
or Executive Order 13045, entitled Protection of Children from
Environmental Health Risks and Safety Risks (62 FR 19885, April 23,
1997). This final rule does not contain any information collections
subject to OMB approval under the Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., nor does it require any special considerations
under Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the temporary
tolerance exemption 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
[[Page 26546]]
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).
VIII. 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: May 20, 2009.
W. Michael McDavit,
Acting 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(b) is revised to read as follows:
Sec. 180.1206 Aspergillus flavus AF36, exemption from the requirement
of a tolerance.
* * * * *
(b) Aspergillus flavus AF36 is temporarily exempt from the
requirement of a tolerance on pistachio when used in accordance with
the Experimental Use Permit, EPA File Symbol 71693-EUP-1. This
temporary exemption from tolerance expires on December 31, 2011.
* * * * *
[FR Doc. E9-12788 Filed 6-2-09; 8:45 am]
BILLING CODE 6560-50-S
