Document ID: EPA-HQ-OPP-2010-0101-0006
Agency: epa
Document Type: Rule
Title: Exemptions from the Requirements of Tolerances: Aspergillus flavus AF36
Posted Date: 2011-03-23T04:00Z

[Federal Register Volume 76, Number 56 (Wednesday, March 23, 2011)]
[Rules and Regulations]
[Pages 16297-16301]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-6545]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0101; FRL-8868-7]

Aspergillus flavus AF36; 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 microbial pesticide, Aspergillus 
flavus AF36, in or on corn food and feed commodities, when applied/used 
as an antifungal agent. The Arizona Cotton Research and Protection 
Council submitted a petition to EPA under the Federal Food, Drug, and 
Cosmetic Act (FFDCA), requesting an amendment to the existing exemption 
from the requirement of a tolerance for Aspergillus flavus AF36. This 
regulation eliminates the need to establish a maximum permissible level 
for residues of Aspergillus flavus AF36 under the FFDCA.

DATES: This regulation is effective March 23, 2011. Objections and 
requests for hearings must be received on or before May 23, 2011, 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-2010-0101. 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 Office of Pesticide Programs (OPP) Regulatory Public 
Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal 
Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays. The Docket 
Facility telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Shanaz Bacchus, Biopesticides and 
Pollution Prevention Division (7511P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 308-8097; e-mail 
address: bacchus.shanaz@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially

[[Page 16298]]

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 get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Printing Office's e-CFR site at http://www.gpoaccess.gov/ecfr.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2010-0101 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
May 23, 2011. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    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. Information not marked confidential pursuant to 40 CFR part 2 
may be disclosed publicly by EPA without prior notice. Submit a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2010-0101, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: OPP Regulatory Public Docket (7502P), Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of March 3, 2010 (75 FR 9596) (FRL-8811-2), 
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 
9E7662) by the Arizona Cotton Research and Protection Council, 3721 
East Wier Ave., Phoenix, AZ 85040-2933. The petition requested that 40 
CFR 180.1206 be amended by establishing an exemption from the 
requirement of a tolerance for residues of Aspergillus flavus AF36 in 
or on corn food and feed commodities. This notice referenced a summary 
of the petition prepared on behalf of the petitioner, Arizona Cotton 
Research and Protection Council, which is available in the docket, 
http://www.regulations.gov. Comments were received on the notice of 
filing. EPA's response to these comments is discussed in Unit VII.C.
    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 EPA 
consider ``available information concerning the cumulative effects of 
[a particular pesticide's] residues and other substances that have a 
common mechanism of toxicity.''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. First, EPA determines the 
toxicity of pesticides. Second, EPA examines exposure to the pesticide 
through food, drinking water, and through other exposures that occur as 
a result of pesticide use in residential settings.

III. Toxicological Profile

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action and considered its validity, completeness, and reliability, 
and the relationship of this information to human risk. EPA has also 
considered available information concerning the variability of the 
sensitivities of major identifiable subgroups of consumers, including 
infants and children.
    The nature and toxicological profile of Aspergillus flavus AF36 was 
previously described in the Federal Register of July 14, 2003 (68 FR 
41541) (FRL-7311-6). Those health effects data were the basis for 
establishing the tolerance exemption for Aspergillus flavus AF36, a 
non-aflatoxin-producing strain of Aspergillus flavus, in or on cotton 
and its food/feed commodities in 40 CFR 180.1206 and also for temporary 
tolerance exemptions for experimental use of Aspergillus flavus AF36 on 
pistachio (72 FR 28871, May 23, 2007) (FRL-8129-4) and on corn (72 FR 
72965, Dec. 26, 2007) (FRL-8342-1). EPA has reviewed the available data 
in support of this action.
    Aspergillus flavus AF36 is neither toxic nor infective via the oral 
and pulmonary routes. It was placed in Toxicity Category IV for acute 
oral effects. The Toxicity Category III designation for acute 
inhalation effects is based on the granular nature of the pesticide and 
the submitted pulmonary studies. This microbial pesticide has been used 
for more than a decade in experimental laboratory and field trials and 
in agricultural practice on cotton in Arizona, California, and Texas 
without any reports of adverse dermal irritation or hypersensitivity 
effects. Data and information from the public literature

[[Page 16299]]

indicate that there will not be any incremental harm from the use of 
Aspergillus flavus AF36 for reduction of aflatoxin. No further 
toxicological data are required to support this exemption from the 
requirement of a tolerance for Aspergillus flavus AF36 in or on the 
food and feed commodities of corn.

IV. Aggregate Exposure

    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

    1. Food. Current uses of Aspergillus flavus AF36 include use on 
cotton, pistachios, and corn. EPA does not expect these uses to result 
in any exposure that is greater than background levels of Aspergillus 
flavus. As a microbial pesticide for use on corn, Aspergillus flavus 
AF36 is labeled for application from the V7 growth stage (i.e., 
approximately 21-25 days after plant emergence) until silking (i.e., 
approximately 55-66 days after plant emergence). Once applied to corn 
and after exposure to moisture, Aspergillus flavus AF36 germinates, 
using the carrier upon which it is placed as a nutrient source, and 
effectively displaces aflatoxin-producing strains of Aspergillus flavus 
without increasing levels of cyclopiazonic acid (Ref. 1). Further, 
multiple-year studies, which monitored air and soil populations of 
Aspergillus flavus, including strain AF36, in cotton fields, 
demonstrated replacement of toxigenic (aflatoxin-producing) fungi with 
atoxic fungi without an increase in the overall quantity of Aspergillus 
flavus beyond normal background levels (Refs. 2 and 3). Although 
residues from the use of pesticides containing Aspergillus flavus AF36 
will likely be present on corn at the time of harvest (although likely 
not at higher levels than background), much like other microbial pest 
control agents, commodity-processing procedures (e.g., peeling, 
shucking, washing, and cooking) should further reduce levels of 
Aspergillus flavus AF36 below typical background levels (Ref. 4). 
Finally, even with the potential for negligible exposure to Aspergillus 
flavus AF36 on edible corn commodities, a previously reviewed and 
described acute oral toxicity and pathogenicity study (see Unit III. of 
the Federal Register of July 14, 2003 (68 FR 41541) (FRL-7311-6)) 
showed no toxicity or infectivity in animals exposed to high levels of 
this active ingredient.
    2. Drinking water exposure. Exposure to Aspergillus flavus AF36 via 
drinking water from all uses of Aspergillus flavus AF36 is not likely 
to be greater than current/existing exposures to Aspergillus flavus 
strains, which are already present in the environment. Potential risks 
via exposure to drinking water or runoff may be mitigated by, among 
other things, percolation through soil. Thus, EPA expects exposure via 
drinking water from the proposed use of this non-aflatoxin-producing 
strain of Aspergillus flavus to be low, or at least not greater than 
existing background levels. In any event, any drinking water exposure 
is not likely to pose any incremental risk to adult humans, infants and 
children because of the lack of toxicity or infectivity of this 
substance. In fact, displacement of the toxigenic strains of 
Aspergillus flavus by AF36 may decrease exposure and risk to the 
toxigenic strains of Aspergillus flavus in the environment.

B. Other Non-Occupational Exposure

    Dermal and inhalation non-occupational exposure are expected to be 
minimal to non-existent for the proposed use of Aspergillus flavus AF36 
in or on corn. Aspergillus flavus AF36 is to be applied to agricultural 
sites not in the proximity of residential areas, schools, nursing 
homes, or daycares. Additionally, the Aspergillus flavus AF36 product 
to be applied to corn is in a granular form, thereby minimizing spray 
drift even for application methods (e.g., aerial) that may be more 
likely to result in pesticide movement offsite.

V. Cumulative Effects From Substances With a Common Mechanism of 
Toxicity

    Section 408(b)(2)(D)(v) of FFDCA requires that, when considering 
whether to establish, modify, or revoke a tolerance, EPA consider 
``available information concerning the cumulative effects of [a 
particular pesticide's] residues and other substances that have a 
common mechanism of toxicity.''
    EPA has not found Aspergillus flavus AF36 to share a common 
mechanism of toxicity with any other substances, and Aspergillus flavus 
AF36 does not appear to produce a toxic metabolite produced by other 
substances. For the purposes of this tolerance action, therefore, EPA 
has assumed that Aspergillus flavus AF36 does not have a common 
mechanism of toxicity with other substances. Following from this, 
therefore, EPA concludes that there are no cumulative effects 
associated with Aspergillus flavus AF36 that need to be considered. For 
information regarding EPA's efforts to determine which chemicals have a 
common mechanism of toxicity and to evaluate the cumulative effects of 
such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

VI. Determination of Safety for U.S. Population, Infants and Children

    There is reasonable certainty that no harm will result from 
aggregate exposures to residues of Aspergillus flavus AF36, in its use 
as an antifungal agent, to the U. S. population, including infants and 
children. This includes all anticipated dietary exposures and all other 
exposures for which there is reliable information. As discussed 
previously, there appears to be no potential for harm from this fungus 
in its use as an antifungal agent via dietary exposure since the 
organism is non-toxic and non-pathogenic to animals and humans. EPA has 
arrived at this conclusion based on the very low levels of mammalian 
toxicity for acute oral and pulmonary effects with no toxicity or 
infectivity at the doses tested (See Unit III. above).
    FFDCA section 408(b)(2)(C) provides that EPA shall apply an 
additional ten-fold margin of exposure (safety) for infants and 
children in the case of threshold effects to account for prenatal and 
postnatal toxicity and the completeness of the data base unless EPA 
determines that a different margin of exposure (safety) will be safe 
for infants and children. Margins of exposure (safety) are often 
referred to as uncertainty (safety) factors. In this instance, based on 
all the available information, EPA concludes that the fungus, 
Aspergillus flavus AF36, is non-toxic to mammals, including infants and 
children. Because there are no threshold effects of concern to infants, 
children and adults when Aspergillus flavus AF36 is used as labeled, 
the provision requiring an additional margin of safety does not apply. 
As a result, EPA has not used a margin of exposure (safety) approach to 
assess the safety of Aspergillus flavus AF36.

VII. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since 
EPA is establishing an exemption from the requirement of a tolerance 
without any numerical limitation.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with

[[Page 16300]]

international standards whenever possible, consistent with U.S. food 
safety standards and agricultural practices. In this context, EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and 
Agriculture Organization/World Health Organization food standards 
program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established a MRL for Aspergillus flavus AF36.

C. Response to Comments

    In total, four comments were received in response to the Federal 
Register notice published by EPA to announce receipt of the Arizona 
Cotton Research and Protection Council's petition. Three comments 
expressed support for the petition, while the other comment was filed 
in opposition.
    The one substantive, negative comment indicated overall support for 
Aspergillus flavus NRRL 21882, another microbial pesticide intended for 
aflatoxin reduction. Primarily, this commenter articulated concern 
about the possible expression of cyclopiazonic acid (CPA) by the 
Aspergillus flavus 36 atoxigenic strain. That is, the commenter 
asserted that, while reduction of aflatoxin is an admirable goal, the 
substitution of one mycotoxin, aflatoxin, for another, CPA (albeit a 
less toxic one), was not acceptable. The commenter claimed that CPA 
could only be observed in field trials and was not directly observed by 
analysis of the active ingredient.
    Field trial data presented by the petitioner to EPA demonstrated 
that there was no increase in CPA levels above background in treated 
corn. In addition, the use of Aspergillus flavus AF36 reduced aflatoxin 
levels in the treated fields compared to untreated plots. Given this 
new information (See Ref. 1), as well as previously reviewed data on 
Aspergillus flavus AF36, EPA has concluded there is a reasonable 
certainty that no harm will result to the U.S. population, including 
infants and children, from aggregate exposure to residues of 
Aspergillus flavus AF36 in or on the food and feed commodities of corn, 
when applied/used as an antifungal agent. Thus, under the standard in 
FFDCA section 408(c)(2), a tolerance exemption is appropriate.

VIII. Conclusions

    EPA concludes that there is a reasonable certainty that no harm 
will result to the U.S. population, including infants and children, 
from aggregate exposure to residues of Aspergillus flavus AF36. 
Therefore, an exemption is established for residues of Aspergillus 
flavus AF36 in or 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, when applied/used as 
an antifungal agent.

IX. References

1. U.S. EPA. 2011. Aspergillus flavus AF36 Use on Corn. Memorandum 
from J.V. Gagliardi, PhD and J.L. Kough, PhD to S. Bacchus dated 
February 24, 2011 (available as ``Supporting & Related Materials'' 
within docket ID number EPA-HQ-OPP-2010-0101 at http://www.regulations.gov.).
2. U.S. EPA. 2003. Environmental Hazard Assessment for the Microbial 
Pesticide, Aspergillus flavus AF36 for Conditional Registration in 
Arizona and EUP Extension in Texas. Memorandum from G.S. Tomimatsu, 
PhD and Z. Vaituzis, PhD to S. Bacchus dated May 16, 2003.
3. U.S. EPA. 2003. BPPD Review of Soil and Air Monitoring Studies 
and Product Performance Testing (Efficacy) Submitted by USDA 
Southern Regional Research Center/IR-4 as a Condition of 
Registration and EUP Extension (Texas) for Aspergillus flavus AF36. 
Memorandum from G.S. Tomimatsu, PhD and J. Kough, PhD to S. Bacchus 
dated May 15, 2003.
4. U.S. EPA. 1996. Microbial Pesticide Test Guidelines--Background 
for Residue Analysis of Microbial Pest Control Agents (OPPTS 
885.2000). Available from: http://www.epa.gov/ocspp/pubs/frs/publications/Test_Guidelines/series885.htm.

X. Statutory and Executive Order Reviews

    This final rule establishes an exemption from the requirement of a 
tolerance under section 408(d) of FFDCA in response to a petition 
submitted to EPA. 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 
exemption in this final rule, do not require the issuance of a proposed 
rule, the requirements of the Regulatory Flexibility Act (RFA) (5 
U.S.C. 601 et seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes. As a result, this 
action does not 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, EPA 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, EPA 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) (Pub. L. 104-4).
    This action does not involve any technical standards that would 
require EPA 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).

XI. 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

[[Page 16301]]

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: March 11, 2011.
Keith A. Matthews,
Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.1206, paragraph (c) is revised to read as follows:

Sec.  180.1206  Aspergillus flavus AF36; exemption from the requirement 
of a tolerance.

* * * * *
    (c) An exemption from the requirement of a tolerance is established 
for residues of Aspergillus flavus AF36 in or 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, 
when applied/used as an antifungal agent.

[FR Doc. 2011-6545 Filed 3-22-11; 8:45 am]
BILLING CODE 6560-50-P