Document ID: EPA-HQ-OPP-2008-0381-0004
Agency: epa
Document Type: Rule
Title: Aspergillus flavus NRRL 21882; Exemption from the Requirement of a Tolerance
Posted Date: 2008-10-01T04:00Z

[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]                         

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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