[Federal Register: October 1, 2008 (Volume 73, Number 191)]
[Rules and Regulations]
[Page 56995-56998]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01oc08-11]
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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 http://
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 http://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
http://www.regulations.gov, you may access this Federal Register
document
[[Page 56996]]
electronically through the EPA Internet under the ``Federal Register''
listings at http://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 http://
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: http://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
[[Page 56997]]
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.
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 180.1254 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