Aspergillus flavus NRRL 21882; Exemption from the Requirement of a Tolerance, 56995-56998 [E8-22957]
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56995
Federal Register / Vol. 73, No. 191 / Wednesday, October 1, 2008 / Rules and Regulations
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[FR Doc. E8–22685 Filed 9–30–08; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2008–0381; FRL–8383–9]
Aspergillus flavus NRRL 21882;
Exemption from the Requirement of a
Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
ebenthall on PROD1PC60 with RULES
AGENCY:
SUMMARY: This regulation establishes an
exemption from the requirement of a
tolerance for residues of the fungal
active ingredient Aspergillus flavus
NRRL 21882 on the food and feed
commodities of corn: Corn, field, forage;
corn, field, grain; corn, field, stover;
corn, field, aspirated grain fractions;
corn, sweet, kernel plus cob with husk
removed; corn, sweet, forage; corn,
sweet, stover; corn, pop, grain; and corn,
pop, stover when applied/used as an
anti-fungal agent to displace aflatoxinproducing Aspergillus flavus from
treated commodities. Circle One Global,
Inc. submitted a petition to EPA under
the Federal Food, Drug, and Cosmetic
Act (FFDCA), requesting an exemption
from the requirement of a tolerance.
This regulation eliminates the need to
establish a maximum permissible level
for residues of Aspergillus flavus NRRL
21882.
VerDate Aug<31>2005
15:26 Sep 30, 2008
This regulation is effective
October 1, 2008. Objections and
requests for hearings must be received
on or before December 1, 2008, and
must be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2008–0381. 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),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
DATES:
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(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
E:\FR\FM\01OCR1.SGM
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56996
Federal Register / Vol. 73, No. 191 / Wednesday, October 1, 2008 / Rules and Regulations
ebenthall on PROD1PC60 with RULES
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 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–2008–0381 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 December 1, 2008.
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing that does not
contain any CBI for inclusion in the
public docket that is described in
ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit your
copies, identified by docket ID number
EPA–HQ–OPP–2008–0381, 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 June 18,
2008 (72 FR 34734) (FRL–8366–9), EPA
issued a notice pursuant to section
VerDate Aug<31>2005
15:26 Sep 30, 2008
Jkt 217001
408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide tolerance petition (PP 7F7302)
by Circle One Global, Inc. (Circle One),
P.O. Box 28, Shellman, GA 39886–0028.
The petition requested that 40 CFR
180.1254 be amended by expanding the
existing exemption from the
requirement of a tolerance for residues
of Aspergillus flavus NRRL 21882 on
corn. A summary of the petition
prepared by the petitioner Danny Gay,
Acta Group, 1203 Nineteenth St., NW.,
Suite 300, Washington DC 20036, on
behalf of Circle One Global, Inc., was
included in the docket at
www.regulations.gov (Docket No. EPA–
HQ–OPP–2008–0381). On July 9, 2008,
Acta Group posted a comment to this
docket to clarify that the pending
amendment to the current exemption
from tolerance for Aspergillus flavus
NRRL 21882 is intended to apply to
field corn, sweet corn, and pop corn as
harvested. The tolerance exemption is
being granted for these food
commodities on the basis of the
toxicology studies which support all
food commodities.
A temporary exemption from the
requirement of tolerance for Aspergillus
flavus NRRL 21882 on corn currently
exists at 40 CFR 180.1254(b). That
temporary tolerance is connected with
Experimental Use Permit No. 75624EUP-2 and is set to expire on May 2,
2009. The Agency issued this temporary
rule on May 16, 2007, after determining
that the temporary exemption from the
requirement of tolerance was safe (72 FR
27460, May 16, 2007).
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
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
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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.
Aspergillus flavus NRRL 21882 is a
non-aflatoxin-producing fungal active
ingredient for use in microbial
pesticides. It will be used to displace
the ubiquitous Aspergillus flavus group
of microbes, many of which can
produce aflatoxin, a potent carcinogen.
The toxicological profile of this
conditionally registered active
ingredient has been previously
described in the final rule of the Federal
Register of June 30, 2004, (69 FR 39341)
(FRL–7364–2). On the basis of those
studies, the exemption from tolerance of
Aspergillus flavus NRRL 21882, a nonaflatoxin-producing strain of Aspergillus
flavus, on peanuts was established in 40
CFR 180.1254.
The acute oral toxicology studies
provided for peanuts are cited in
support of the tolerance exemption for
field, pop and sweet corn. Those studies
placed Aspergillus flavus NRRL 21882
in Toxicity Category IV for acute oral
effects. This active ingredient was not
toxic, infective or pathogenic to
mammals on the basis of acute oral and
pulmonary studies. That database
supporting the exemption from
tolerance on peanut also supports the
proposed exemption of this active
ingredient on corn. Even though the
active ingredient has demonstrated toxic
and infective effects in the acute
intraperitoneal studies, there was
clearance from all tissues by day 22. The
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Federal Register / Vol. 73, No. 191 / Wednesday, October 1, 2008 / Rules and Regulations
results of these studies were considered
a worse case scenario relevant to issues
of occupational exposure for which the
agency required appropriate Personal
Protective Equipment (PPE) to mitigate
risk to workers. In addition, the
pesticide is not to be applied to
residential areas, but rather to
commercial corn fields. Thus, potential
non-occupational exposure is not
expected. For a summary of the studies
and discussions of dietary and nondietary, non-occupational dermal and
inhalation exposures, as well as
aggregate and cumulative, exposures,
and potential endocrine effects refer to
the aforesaid June 30, 2004 final rule (69
FR 39341). All studies met, and
continue to meet, the safety standards of
the Food Quality Protection Act (FQPA)
of 1996. This pesticide has been used
for more than a decade in experimental
laboratory and field trials without any
reports of adverse dermal irritation or
hypersensitivity effects.
The Agency has determined that the
previously reviewed acute toxicological
studies do support the proposed
exemption from tolerance of Aspergillus
flavus NRRL 21882 on corn. Summaries
of the rationales for this determination
may be found in the aforesaid Federal
Register final rule of June 30, 2004. No
further toxicological data are required
for this exemption from the requirement
of a tolerance for Aspergillus flavus
NRRL 21882 on corn. The applicant
must, however, report any incidents of
hypersensitivity, or any other adverse
effects to comply with the requirements
of FIFRA section 6(a)(2).
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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).
A. Dietary Exposure
In evaluating dietary exposure to
Aspergillus flavus NRRL 21882, EPA
considered exposure under the
petitioned-for tolerances as well as the
existing Aspergillus flavus NRRL 21882
tolerance for peanuts in (40 CFR
180.1254(a)).
1. Food. Pesticides containing
Aspergillus flavus NRRL 21882 are to be
applied aerially to corn once per season
at the first sign of corn tasseling.
Because there is a long period of time
between application and harvesting,
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15:26 Sep 30, 2008
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56997
residues of Aspergillus flavus NRRL
21882 are not expected to be greater
than the normal background levels,
when the food commodity is harvested.
In addition, corn and its byproducts will
be subject to several stages of food
processing and manufacturing. These
stages include washing, threshing,
dehulling, dry and wet milling, and
fractionation by aspiration and the other
food manufacturing and processing
technologies which are associated with
preparing and marketing corn as a food
commodity. Thus, because of the low
application rate and food processing
steps, this naturally occurring active
ingredient is not expected to be present
at greater than background levels on
consumable corn commodities. Even if
it is present, it is not likely to cause
harm because it is not toxic, infective or
pathogenic as demonstrated in the acute
oral toxicity study in rats.
These observations from the acute
toxicology tests are also relevant to
dietary exposure of human adults,
infants and children to peanuts treated
with Aspergillus flavus NRRL 21882.
The Agency, taking both crops into
consideration, concluded that the
aggregate exposure to this active
ingredient with low toxicity potential
will not cause harm if the pesticide is
used as labeled.
2. Drinking water exposure. The
analysis provided for the tolerance
exemption for residues of Aspergillus
flavus NRRL 21882 on peanuts also
supports the drinking water exposure
analysis for corn. As in the case of
peanuts, the pesticide is to be applied
in drought ridden areas and is not
directly applied to crops grown in
water. Thus accumulation in drinking
water is not expected. 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. Thus
incremental exposure via drinking water
is not expected when both corn and
peanuts are treated.
21882, is not intended for residential
applications. Instead, it is to be applied
once per growing season to commercial
agricultural fields. Pesticide drift is not
expected to residential areas from the
agricultural applications of the granular
End-use Product which is applied at a
very low rate (approximately 1 gram or
0.002 pound of active ingredient per
acre). Thus, non-occupational
residential exposure is expected to be
minimal to non-existent.
In summary, the Agency considered
dietary exposure (including drinking
water), as well as non-occupational
exposure to treated peanuts and corn,
and concluded that aggregate exposure
to Aspergillus flavus NRRL 21882 will
not cause harm to the U.S. adult,
population, infants and children.
B. Other Non-Occupational Exposure
Non-occupational dermal and
inhalation exposure is expected to be
minimal to non-existent when the
microbial pesticide containing the
active ingredient Aspergillus flavus
NRRL 21882 is used as labeled on corn
and peanuts. For both crops, the
pesticide is to be applied to agricultural
sites not in the proximity of residential
areas, schools, nursing homes or
daycares. While there is a potential for
dermal sensitivity to the Aspergillus
group of fungi, the specific pesticide at
issue here, Aspergillus flavus NRRL
A. Endocrine Disruptors
See Federal Register, June 30, 2004,
(69 FR 39341).
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V. Cumulative Effects
Section 408(b)(2)(D)(v) of the FFDCA
requires the Agency to consider the
cumulative effect of exposure to
Aspergillus flavus NRRL 21882 and to
other substances that have a common
mechanism of toxicity. These
considerations include the possible
cumulative effects of such residues on
infants and children. Based on tests in
mammalian systems, Aspergillus flavus
NRRL 21882 does not appear to be toxic
to humans via dietary and pulmonary
exposure. Therefore, the requirement to
consider cumulative effects does not
apply.
VI. Determination of Safety for U.S.
Population, Infants and Children
For the same reasons as stated in the
rule issued on June 30, 2004 (69 FR
39341), the Agency has determined that
the additional margin of safety is not
necessary to protect infants and
children, and that not adding any
additional margin of safety will be safe
for infants and children. As a result,
EPA has not used a margin of exposure
(safety) approach to assess the safety of
Aspergillus flavus NRRL 21882.
VII. Other Considerations
B. Analytical Method
See Federal Register, June 30, 2004,
(69 FR 39341).
C. Codex Maximum Residue Level
There is no Codex Maximum Residue
Level (MRL) for residues of Aspergillus
flavus NRRL 21882 on corn.
VIII. Conclusions
In summary, the Agency has
determined that, based on available data
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Federal Register / Vol. 73, No. 191 / Wednesday, October 1, 2008 / Rules and Regulations
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and information, there is a reasonable
certainty that the use of Aspergillus
flavus NRRL 21882 on field, sweet and
pop corn will not cause harm to the U.S.
adult, children and infant populations
via dietary, aggregate and cumulative
exposure. Thus, an exemption from the
requirement of a tolerance on field,
sweet and pop corn is being granted.
IX. 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 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 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
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15:26 Sep 30, 2008
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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).
X. 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.
aspirated grain fractions; corn, sweet,
kernel plus cob with husk removed;
corn, sweet, forage; corn, sweet, stover;
corn, pop, grain; and corn, pop, stover.
[FR Doc. E8–22957 Filed 9–30–08; 8:45 am]
BILLING CODE 6560–50–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–1534–CN]
42 CFR Part 413
RIN 0938–AP11
Medicare Program; Prospective
Payment System and Consolidated
Billing for Skilled Nursing Facilities;
Correction
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Final rule; correction.
AGENCY:
SUMMARY: This document corrects
technical errors that appeared in the
August 8, 2008 Federal Register
entitled, ‘‘Medicare Program;
Prospective Payment System and
Consolidated Billing for Skilled Nursing
Facilities for FY 2009.’’
DATES: Effective Date: This correction is
effective October 1, 2008.
FOR FURTHER INFORMATION CONTACT: Bill
Ullman, (410) 786–5667.
SUPPLEMENTARY INFORMATION:
I. Background
Therefore, 40 CFR chapter I is
amended as follows:
In FR Doc. E8–17948 of August 8,
2008 (73 FR 46416), there were two
technical errors that this notice serves to
identify and correct. The corrections in
this correction notice are effective as if
they had been included in the document
published on August 8, 2008.
Accordingly, the corrections are
effective October 1, 2008.
PART 180—[AMENDED]
II. Summary of Errors
Dated: September 19, 2008.
Janet L. Andersen,
Director, Biopesticides and Pollution
Prevention Division, Office of Pesticide
Programs.
■
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.1254 is amended by
revising paragraph (b) to read as follows:
■
§ 180.1254 Aspergillus flavus NRRL 21882;
exemption from requirement of a tolerance.
* * * * *
(b) An exemption from the
requirement of a tolerance is established
for residues of Aspergillus flavus NRRL
21882 on corn, field, forage; corn, field,
grain; corn, field, stover; corn, field,
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On page 46430 of the August 8, 2008
final rule, we are correcting the title of
Table 10. This table illustrates the
skilled nursing facility (SNF)
prospective payment system (PPS)
payment rate computations for a
hypothetical ‘‘XYZ’’ SNF located in
Cedar Rapids, IA. In the table’s title, the
wage index value for Cedar Rapids, IA
is incorrectly identified as 0.8924.
Accordingly, in section III of this
document (‘‘Correction of Errors’’), we
are correcting the wage index value in
the title of Table 10 to reflect the correct
wage index value of 0.8919. We note
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Agencies
[Federal Register Volume 73, Number 191 (Wednesday, October 1, 2008)]
[Rules and Regulations]
[Pages 56995-56998]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-22957]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2008-0381; FRL-8383-9]
Aspergillus flavus NRRL 21882; Exemption from the Requirement of
a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of the fungal active ingredient Aspergillus
flavus NRRL 21882 on the food and feed commodities of corn: Corn,
field, forage; corn, field, grain; corn, field, stover; corn, field,
aspirated grain fractions; corn, sweet, kernel plus cob with husk
removed; corn, sweet, forage; corn, sweet, stover; corn, pop, grain;
and corn, pop, stover when applied/used as an anti-fungal agent to
displace aflatoxin-producing Aspergillus flavus from treated
commodities. Circle One Global, Inc. submitted a petition to EPA under
the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an
exemption from the requirement of a tolerance. This regulation
eliminates the need to establish a maximum permissible level for
residues of Aspergillus flavus NRRL 21882.
DATES: This regulation is effective October 1, 2008. Objections and
requests for hearings must be received on or before December 1, 2008,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2008-0381. 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), 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
[[Page 56996]]
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 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-2008-0381 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 December 1, 2008.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2008-0381, 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 June 18, 2008 (72 FR 34734) (FRL-8366-
9), 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 7F7302) by Circle One Global, Inc. (Circle One), P.O. Box
28, Shellman, GA 39886-0028. The petition requested that 40 CFR
180.1254 be amended by expanding the existing exemption from the
requirement of a tolerance for residues of Aspergillus flavus NRRL
21882 on corn. A summary of the petition prepared by the petitioner
Danny Gay, Acta Group, 1203 Nineteenth St., NW., Suite 300, Washington
DC 20036, on behalf of Circle One Global, Inc., was included in the
docket at www.regulations.gov (Docket No. EPA-HQ-OPP-2008-0381). On
July 9, 2008, Acta Group posted a comment to this docket to clarify
that the pending amendment to the current exemption from tolerance for
Aspergillus flavus NRRL 21882 is intended to apply to field corn, sweet
corn, and pop corn as harvested. The tolerance exemption is being
granted for these food commodities on the basis of the toxicology
studies which support all food commodities.
A temporary exemption from the requirement of tolerance for
Aspergillus flavus NRRL 21882 on corn currently exists at 40 CFR
180.1254(b). That temporary tolerance is connected with Experimental
Use Permit No. 75624-EUP-2 and is set to expire on May 2, 2009. The
Agency issued this temporary rule on May 16, 2007, after determining
that the temporary exemption from the requirement of tolerance was safe
(72 FR 27460, May 16, 2007).
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 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.
Aspergillus flavus NRRL 21882 is a non-aflatoxin-producing fungal
active ingredient for use in microbial pesticides. It will be used to
displace the ubiquitous Aspergillus flavus group of microbes, many of
which can produce aflatoxin, a potent carcinogen. The toxicological
profile of this conditionally registered active ingredient has been
previously described in the final rule of the Federal Register of June
30, 2004, (69 FR 39341) (FRL-7364-2). On the basis of those studies,
the exemption from tolerance of Aspergillus flavus NRRL 21882, a non-
aflatoxin-producing strain of Aspergillus flavus, on peanuts was
established in 40 CFR 180.1254.
The acute oral toxicology studies provided for peanuts are cited in
support of the tolerance exemption for field, pop and sweet corn. Those
studies placed Aspergillus flavus NRRL 21882 in Toxicity Category IV
for acute oral effects. This active ingredient was not toxic, infective
or pathogenic to mammals on the basis of acute oral and pulmonary
studies. That database supporting the exemption from tolerance on
peanut also supports the proposed exemption of this active ingredient
on corn. Even though the active ingredient has demonstrated toxic and
infective effects in the acute intraperitoneal studies, there was
clearance from all tissues by day 22. The
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results of these studies were considered a worse case scenario relevant
to issues of occupational exposure for which the agency required
appropriate Personal Protective Equipment (PPE) to mitigate risk to
workers. In addition, the pesticide is not to be applied to residential
areas, but rather to commercial corn fields. Thus, potential non-
occupational exposure is not expected. For a summary of the studies and
discussions of dietary and non-dietary, non-occupational dermal and
inhalation exposures, as well as aggregate and cumulative, exposures,
and potential endocrine effects refer to the aforesaid June 30, 2004
final rule (69 FR 39341). All studies met, and continue to meet, the
safety standards of the Food Quality Protection Act (FQPA) of 1996.
This pesticide has been used for more than a decade in experimental
laboratory and field trials without any reports of adverse dermal
irritation or hypersensitivity effects.
The Agency has determined that the previously reviewed acute
toxicological studies do support the proposed exemption from tolerance
of Aspergillus flavus NRRL 21882 on corn. Summaries of the rationales
for this determination may be found in the aforesaid Federal Register
final rule of June 30, 2004. No further toxicological data are required
for this exemption from the requirement of a tolerance for Aspergillus
flavus NRRL 21882 on corn. The applicant must, however, report any
incidents of hypersensitivity, or any other adverse effects to comply
with the requirements of FIFRA section 6(a)(2).
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).
A. Dietary Exposure
In evaluating dietary exposure to Aspergillus flavus NRRL 21882,
EPA considered exposure under the petitioned-for tolerances as well as
the existing Aspergillus flavus NRRL 21882 tolerance for peanuts in (40
CFR 180.1254(a)).
1. Food. Pesticides containing Aspergillus flavus NRRL 21882 are to
be applied aerially to corn once per season at the first sign of corn
tasseling. Because there is a long period of time between application
and harvesting, residues of Aspergillus flavus NRRL 21882 are not
expected to be greater than the normal background levels, when the food
commodity is harvested. In addition, corn and its byproducts will be
subject to several stages of food processing and manufacturing. These
stages include washing, threshing, dehulling, dry and wet milling, and
fractionation by aspiration and the other food manufacturing and
processing technologies which are associated with preparing and
marketing corn as a food commodity. Thus, because of the low
application rate and food processing steps, this naturally occurring
active ingredient is not expected to be present at greater than
background levels on consumable corn commodities. Even if it is
present, it is not likely to cause harm because it is not toxic,
infective or pathogenic as demonstrated in the acute oral toxicity
study in rats.
These observations from the acute toxicology tests are also
relevant to dietary exposure of human adults, infants and children to
peanuts treated with Aspergillus flavus NRRL 21882. The Agency, taking
both crops into consideration, concluded that the aggregate exposure to
this active ingredient with low toxicity potential will not cause harm
if the pesticide is used as labeled.
2. Drinking water exposure. The analysis provided for the tolerance
exemption for residues of Aspergillus flavus NRRL 21882 on peanuts also
supports the drinking water exposure analysis for corn. As in the case
of peanuts, the pesticide is to be applied in drought ridden areas and
is not directly applied to crops grown in water. Thus accumulation in
drinking water is not expected. 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. Thus incremental exposure via drinking water is not expected
when both corn and peanuts are treated.
B. Other Non-Occupational Exposure
Non-occupational dermal and inhalation exposure is expected to be
minimal to non-existent when the microbial pesticide containing the
active ingredient Aspergillus flavus NRRL 21882 is used as labeled on
corn and peanuts. For both crops, the pesticide is to be applied to
agricultural sites not in the proximity of residential areas, schools,
nursing homes or daycares. While there is a potential for dermal
sensitivity to the Aspergillus group of fungi, the specific pesticide
at issue here, Aspergillus flavus NRRL 21882, is not intended for
residential applications. Instead, it is to be applied once per growing
season to commercial agricultural fields. Pesticide drift is not
expected to residential areas from the agricultural applications of the
granular End-use Product which is applied at a very low rate
(approximately 1 gram or 0.002 pound of active ingredient per acre).
Thus, non-occupational residential exposure is expected to be minimal
to non-existent.
In summary, the Agency considered dietary exposure (including
drinking water), as well as non-occupational exposure to treated
peanuts and corn, and concluded that aggregate exposure to Aspergillus
flavus NRRL 21882 will not cause harm to the U.S. adult, population,
infants and children.
V. Cumulative Effects
Section 408(b)(2)(D)(v) of the FFDCA requires the Agency to
consider the cumulative effect of exposure to Aspergillus flavus NRRL
21882 and to other substances that have a common mechanism of toxicity.
These considerations include the possible cumulative effects of such
residues on infants and children. Based on tests in mammalian systems,
Aspergillus flavus NRRL 21882 does not appear to be toxic to humans via
dietary and pulmonary exposure. Therefore, the requirement to consider
cumulative effects does not apply.
VI. Determination of Safety for U.S. Population, Infants and Children
For the same reasons as stated in the rule issued on June 30, 2004
(69 FR 39341), the Agency has determined that the additional margin of
safety is not necessary to protect infants and children, and that not
adding any additional margin of safety will be safe for infants and
children. As a result, EPA has not used a margin of exposure (safety)
approach to assess the safety of Aspergillus flavus NRRL 21882.
VII. Other Considerations
A. Endocrine Disruptors
See Federal Register, June 30, 2004, (69 FR 39341).
B. Analytical Method
See Federal Register, June 30, 2004, (69 FR 39341).
C. Codex Maximum Residue Level
There is no Codex Maximum Residue Level (MRL) for residues of
Aspergillus flavus NRRL 21882 on corn.
VIII. Conclusions
In summary, the Agency has determined that, based on available data
[[Page 56998]]
and information, there is a reasonable certainty that the use of
Aspergillus flavus NRRL 21882 on field, sweet and pop corn will not
cause harm to the U.S. adult, children and infant populations via
dietary, aggregate and cumulative exposure. Thus, an exemption from the
requirement of a tolerance on field, sweet and pop corn is being
granted.
IX. 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 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 tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).
X. 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: September 19, 2008.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of
Pesticide Programs.
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Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
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1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
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2. Section 180.1254 is amended by revising paragraph (b) to read as
follows:
Sec. 180.1254 Aspergillus flavus NRRL 21882; exemption from
requirement of a tolerance.
* * * * *
(b) An exemption from the requirement of a tolerance is established
for residues of Aspergillus flavus NRRL 21882 on corn, field, forage;
corn, field, grain; corn, field, stover; corn, field, aspirated grain
fractions; corn, sweet, kernel plus cob with husk removed; corn, sweet,
forage; corn, sweet, stover; corn, pop, grain; and corn, pop, stover.
[FR Doc. E8-22957 Filed 9-30-08; 8:45 am]
BILLING CODE 6560-50-S