[Federal Register Volume 64, Number 101 (Wednesday, May 26, 1999)]
[Rules and Regulations]
[Pages 28371-28374]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-13192]
[[Page 28371]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300860; FRL-6081-2]
RIN 2070-AB78
Aspergillus flavus AF36; Pesticide Tolerance Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a temporary exemption from the
requirement of a tolerance for residues of the biological Aspergillus
flavus AF36, a non-aflatoxin producing strain of A. flavus, on cotton
when applied/used as an antifungal agent. The Interregional Research
Project Number 4 (IR-4) submitted an amended Pesticide Petition (PP)
5E4575 to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA),
and also to comply with the Food Quality Protection Act of 1996 (FQPA)
requesting an extension of the temporary exemption from the requirement
of a tolerance. This regulation eliminates the need to establish a
maximum permissible level for residues of Aspergillus flavus AF36. The
temporary exemption from the requirement of a tolerance will expire on
December 30, 2000.
DATES: This regulation is effective May 26, 1999. Objections and
requests for hearings must be received by EPA on or before July 26,
1999.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number [OPP-300860], must be submitted to: Hearing Clerk
(1900), Environmental Protection Agency, Rm. M3708, 401 M St., SW.,
Washington, DC 20460. Fees accompanying objections and hearing requests
shall be labeled ``Tolerance Petition Fees'' and forwarded to: EPA
Headquarters Accounting Operations Branch, OPP (Tolerance Fees), P.O.
Box 360277M, Pittsburgh, PA 15251. A copy of any objections and hearing
requests filed with the Hearing Clerk identified by the docket control
number, [OPP-300860], must also be submitted to: Public Information and
Records Integrity Branch, Information Resources and Services Division
(7502C), Office of Pesticide Programs, Environmental Protection Agency,
401 M St., SW., Washington, DC 20460. In person, bring a copy of
objections and hearing requests to Rm. 119, Crystal Mall 2 (CM #2),
1921 Jefferson Davis Hwy., Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may be submitted electronically by sending electronic mail (e-
mail) to: opp-docket. Copies of electronic objections and hearing
requests must be submitted as an ASCII file avoiding the use of special
characters and any form of encryption. Copies of electronic objections
and hearing requests will also be accepted on disks in WordPerfect 5.1/
6.1 file format or ASCII file format. All copies of electronic
objections and hearing requests must be identified by the docket number
[OPP-300860]. No Confidential Business Information (CBI) should be
submitted through e-mail. Copies of electronic objections and hearing
requests on this rule may be filed online at many Federal Depository
Libraries.
FOR FURTHER INFORMATION CONTACT: By mail: Shanaz Bacchus, c/o Product
Manager (PM) 90, Biopesticides and Pollution Prevention Division
(7511C), Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. Office location, telephone number, and e-mail address: 9th
fl., CM #2, 1921 Jefferson Davis Hwy., Arlington, VA, (703) 308-8097,
e-mail: bacchus.shanaz @epa.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register of February 19,
1999 (64 FR 8358) (FRL-6081-2), EPA issued a notice pursuant to section
408 of the FFDCA, 21 U.S.C. 346a, as amended by the FQPA of 1996 (Pub.
L. 104-170) announcing the filing of a pesticide tolerance petition by
the IR-4, New Jersey Agricultural Experiment Station, Technology Center
of New Jersey, Rutgers University, 681 U.S. Highway #1 South, North
Brunswick, NJ 08902-3390. The notice included a summary of the petition
prepared by the petitioner, IR-4. The petition requested that 40 CFR
part 180 be amended by establishing a temporary exemption from the
requirement of a tolerance for residues of Aspergillus flavus AF36 in/
on cotton in Arizona.
Comments submitted to the Agency regarding the proposed use of the
antifungal agent were by the cotton growers in the region who were all
in favor of the extension of the temporary exemption from the
tolerance. Both the toxigenic and atoxigenic strains are naturally
occurring in Arizona. The growers were of the opinion that this
technology is likely to reduce the high levels of the naturally
occurring, toxin-producing strain of A. flavus by displacement.
I. Background and Statutory Findings
New section 408(c)(2)(A)(i) of the 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) 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. Section 408(b)(2)(C) requires 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) 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 us in residential settings.
This extension of the temporary exemption from the requirement of a
tolerance is associated with an extension of an Experimental Use Permit
(69224-EUP-1), published in the Federal Register of February 14, 1996,
(61 FR 5771) (FRL-5347-5), which was granted to the Southern Regional
Research Center, United States Department of Agriculture, Agricultural
Research Service (USDA ARS), 1100 Robert E. Lee Blvd., New Orleans, LA
70179-0687 on May 28, 1996 and expires May 20, 1999. Approximately
1,120 acres of cotton in Yuma County, Arizona, were treated at a rate
of 10 pounds (lbs.) of the pesticide per acre over the 3-year period. A
temporary exemption from the requirement of a tolerance was established
in connection with this EUP as published in the Federal Register of
June 14, 1996, (61 FR 30235) (FRL-5377-6). No adverse effects were
reported in the annual reports which the registrant submitted as
required in the EUP.
[[Page 28372]]
USDA ARS has amended the EUP and extended treatment to a total of
20,000 acres of commercial cotton fields in 5 of the 15 counties in
Arizona. The aerial applications are to be made in the following
counties: Yuma (3,000 A), LaPaz (1,000 A), Maricopa (9,000 A), Mohave
(1,000 A) and Pinal (6,000 A). The antifungal agent is applied prebloom
to the soil of treated cotton fields, where the mycelia germinate to
displace the naturally occurring toxigenic strain.
Of the strains of A. flavus which abound naturally in Arizona, this
atoxigenic L strain comprises 15% of the natural microbial population
in the soil, as opposed to the predominant S or toxigenic S strain.
II. Toxicological Profile
Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed
the available scientific data and other relevant information in support
of this action and considered its validity, completeness and
reliability and the relationship of this information to human risk. EPA
has also considered available information concerning the variability of
the sensitivities of major identifiable subgroups of consumers,
including infants and children.
The toxicological profile in support of the extension of the
temporary exemption from a tolerance of the residues of the atoxigenic
(non-toxin producing) A. flavus AF36 demonstrates that the
LD50 of A. flavus AF36 is greater than 5,000 milligrams/
kilograms (mg/kg). No adverse clinical effects were observed after 14
days in rats treated by gavage with the microbial antifungal agent and
no abnormalities or adverse effects were observed in any of the rats
upon autopsy.
Studies were not conducted to evaluate the potential of the active
ingredient as an agent linked to genotoxicity, or reproductive,
developmental, subchronic or chronic effects, because the researchers
have worked with the proposed microbial antifungal agent for several
years in laboratory and field settings with no adverse effects. Also,
the organism is a naturally occurring, ubiquitous microbe.
III. Aggregate Exposures
In examining aggregate exposure, section 408 of the 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).
There is a reasonable certainty that no harm will result from
aggregate exposure to the U.S. population, including infants and
children, to A. flavus AF36 from the limited use pattern of the
experimental use permit. This includes all anticipated dietary
exposures and all other exposures for which there is reliable
information.
A. Dietary Exposure
1. Food. Application of the microbial pesticide prebloom in the
cultural practice precludes the potential for direct residues of A.
flavus per se to remain on the treated cotton. The proposed strain of
A. flavus, AF36, is atoxigenic, i.e. not producing aflatoxin. Only the
seed of the treated commodity, cotton, is likely to be processed as
food for cottonseed oil. Residues of A. flavus AF36 or its metabolites
are likely to be removed from cotton seed oil during this processing.
Moreover, the applications are proposed for 5 of the 15 counties of
Arizona only, on 3-7% of the total cotton, thus minimizing any
potential dietary exposure. The Food and Drug Administration (FDA)
regulates the levels of aflatoxin in cotton seed meal and other
commodities associated with the production of cotton. Cottonseed is
monitored for aflatoxin content during the ginning process, and all
cotton seed from these experiments will be closely monitored for
aflatoxin content as part of the experimental program. On the basis of
the preceding discussion, dietary exposure to the treated commodity is
likely to be minimal to human adults, infants and children.
exposure to immunocompromised human adults, infants and children.
Moreover, the application of the microbial pesticide to specific
counties during the EUP represents application to approximately 3-7%
cultivated areas in these counties, thus minimizing exposure.
1. Dermal exposure. Non-occupational dermal exposure and risk to
adults, infants and children are not likely if the pesticide is used as
labeled. The antifungal agent is a naturally occurring microbe to be
applied to the soil of cotton fields prebloom. It is ubiquitous in the
environment. If the microbe exhibits dermal sensitizing properties
which is associated with this genus of fungi, the boundaries and the
large particle size of the spores are likely to maintain distribution
near treated areas thus protecting nearby at-risk populations. Based on
the low toxicity potential as evidenced by the data submitted, the
microbial pesticide active ingredient is likely to pose a minimal to
non-existent hazard if used as labeled.
2. Inhalation exposure. Based on the large spore size of AF36, and
on the method of application to the soil of cultivated cotton fields
prebloom with set boundaries, non-occupational inhalation exposure and
risk to human adults, children and infants are likely to be minimal.
IV. Cumulative Effects
There are no other registered products containing Aspergillus
flavus isolate AF36 or any other isolates (strains) of the microbial
active ingredient. Moreover, data submitted to the Agency demonstrate
that this strain does not produce aflatoxin on the crop or in
artificial media in the lab. Data submissions also show that this
strain has been shown to exclude the aflatoxin-producing strain when it
is applied prior to flowering. Thus, the proposed use is not likely to
result in appreciable increases in the long-term population of A.
flavus on the crop beyond naturally occurring levels. Furthermore,
there is no expectation of cumulative effects with other pesticides.
V. Determination of Safety for U.S. Population, Infants and
Children
FFDCA section 408 provides that EPA shall apply an additional
tenfold margin of exposure (safety) for infants and children in the
case of threshold effects to account for pre- 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. In this instance, EPA believes there are reliable data to
support the conclusion that there are no threshold effects of concern
to infants, children and adults when A. flavus AF36 is used as labeled.
As a result, the provision requiring an additional margin of exposure
does not apply. The label will require applicators and other handlers
to wear gloves, a dust/mist filtering respirator with National
Institute of Occupational Safety and Health (NIOSH) approval prefix N-
95, R-95 or P-95, long sleeved shirt and long pants, and shoes plus
socks so worker exposure should not be a problem. Label language
reflecting potential dermal sensitization is also required.
VI. Other Considerations
A. Endocrine Disruptors
EPA does not have any information regarding endocrine effects of
this microbial pesticide at this time. The Agency is not requiring
information on
[[Page 28373]]
the endocrine effects of this pesticide at this time; and Congress
allowed 3 years after August 3, 1996, for the Agency to implement a
screening and testing program with respect to endocrine effects.
B. Analytical Method(s)
Starter cultures are screened on the basis of vegetative
incompatibility with the toxigenic strain, as well as for aflatoxin by
standard procedures, which allow a zero tolerance for aflatoxin
production. A. flavus AF36 does not demonstrate vegetative
compatibility with the toxigenic S strain and has never been found to
produce aflatoxin. According to the data submissions human pathogens
are also within regulatory levels.
Treated cotton and its byproducts are screened for aflatoxin prior
to introduction into the channels of commerce. FDA does not allow
cottonseed products containing aflatoxin at 20 parts per billion (ppb)
or higher to be used in dairy rations. FDA regulations also do not
allow cottonseed products containing aflatoxin above 300 ppb to be used
for feeding beef cattle.
C. Codex Maximum Residue Level
An exemption from temporary tolerance for residues of Aspergillus
flavus isolate AF36 on cotton is currently in effect in conjunction
with an Experimental Use Permit published in the Federal Register of
June 14, 1996 (61 FR 30235).
VII. Objections and Hearing Requests
The new section 408(g) of the FFDCA provides essentially the same
process for persons to ``object'' to a regulation for an exemption from
the requirement of a tolerance issued by EPA under new section 408(d)
and as was provided in the old section 408 and in section 409. However,
the period for filing objections is 60 days, rather than 30 days. EPA
currently has procedural regulations which governs the submission of
objections and hearing requests. These regulations will require some
modification to reflect the new law. However, until those modifications
can be made, EPA will continue to use those procedural regulations with
appropriate adjustments to reflect the new law.
Any person may, by July 26, 1999, file written objections to any
aspect of this regulation and may also request a hearing on those
objections. Objections and hearing requests must be filed with the
hearing clerk, at the address given under the ``ADDRESSES'' section (40
CFR 178.20). A copy of the objections and/or hearing requests filed
with the hearing clerk should be submitted to the OPP docket for this
rulemaking. The objections submitted must specify the provisions of the
regulation deemed objectionable and the grounds for the objections (40
CFR 178.25). Each objection must be accompanied by the fee prescribed
by 40 CFR 180.33(i). EPA is authorized to waive any fee requirement
``when in the judgement of the Administrator such a waiver or refund is
equitable and not contrary to the purpose of this subsection.'' For
additional information regarding tolerance objection fee waivers,
contact James Tompkins, Registration Division (7505C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. Office location, telephone number, and e-mail
address: Rm. 239, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA,
(703) 305-5697, tompkins.jim@epa.gov. Requests for waiver of tolerance
objection fees should be sent to James Hollins, Information Resources
and Services Division (7502C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
If a hearing is requested, the objections must include a statement
of the factual issues(s) on which a hearing is requested, the
requestor's contentions on such issues, and a summary of any evidence
relied upon by the objector (40 CFR 178.27). A request for a hearing
will be granted if the Administrator determines that the material
submitted shows the following: There is a genuine and substantial issue
of fact; there is a reasonable possibility that available evidence
identified by the requestor would, if established resolve one or more
of such issues in favor of the requestor, taking into account
uncontested claims or facts to the contrary; and resolution of the
factual issues(s) in the manner sought by the requestor would be
adequate to justify the action requested (40 CFR 178.32). Information
submitted in connection with an objection or hearing request may be
claimed confidential by marking any part or all of that information as
CBI. Information so marked will not be disclosed except in accordance
with procedures set forth in 40 CFR part 2. A copy of the information
that does not contain CBI must be submitted for inclusion in the public
record. Information not marked confidential may be disclosed publicly
by EPA without prior notice.
VIII. Public Record and Electronic Submissions
EPA has established a record for this regulation under docket
control number [OPP-300860] (including any comments and data submitted
electronically). A public version of this record, including printed,
paper versions of electronic comments, which does not include any
information claimed as CBI, is available for inspection from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The public
record is located in Rm. 119 of the Public Information and Records
Integrity Branch, Information Resources and Services Division (7502C),
Office of Pesticide Programs, Environmental Protection Agency, CM #2,
1921 Jefferson Davis Hwy., Arlington, VA.
Objections and hearing requests may be sent by e-mail directly to
EPA at:
opp-docket@epa.gov
E-mailed objections and hearing requests must be submitted as an
ASCII file avoiding the use of special characters and any form of
encryption.
The official record for this regulation, as well as the public
version, as described in this unit will be kept in paper form.
Accordingly, EPA will transfer any copies of objections and hearing
requests received electronically into printed, paper form as they are
received and will place the paper copies in the official record which
will also include all comments submitted directly in writing. The
official record is the paper record maintained at the Virginia address
in ``ADDRESSES'' at the beginning of this document.
IX. Regulatory Assessment Requirements
A. Certain Acts and Executive Orders
This final rule establishes an exemption from the tolerance
requirement under section 408(d) of the 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). 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., or 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). Nor does it require any
prior consultation as specified by Executive Order 12875, entitled
Enhancing the Intergovernmental Partnership (58 FR 58093, October 28,
1993), or special considerations as required by Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
[[Page 28374]]
Populations and Low-Income Populations (59 FR 7629, February 16,
1994), or require OMB review in accordance with Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997).
In addition, since tolerances and exemptions that are established
on the basis of a petition under FFDCA section 408(d), 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. Nevertheless, the Agency
previously assessed whether establishing tolerances, exemptions from
tolerances, raising tolerance levels or expanding exemptions might
adversely impact small entities and concluded, as a generic matter,
that there is no adverse economic impact. The factual basis for the
Agency's generic certification for tolerance actions published on May
4, 1981 (46 FR 24950), and was provided to the Chief Counsel for
Advocacy of the Small Business Administration.
B. Executive Order 12875
Under Executive Order 12875, entitled Enhancing the
Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may
not issue a regulation that is not required by statute and that creates
a mandate upon a State, local or tribal government, unless the Federal
government provides the funds necessary to pay the direct compliance
costs incurred by those governments. If the mandate is unfunded, EPA
must provide to OMB a description of the extent of EPA's prior
consultation with representatives of affected State, local, and tribal
governments, the nature of their concerns, copies of any written
communications from the governments, and a statement supporting the
need to issue the regulation. In addition, Executive Order 12875
requires EPA to develop an effective process permitting elected
officials and other representatives of State, local, and tribal
governments ``to provide meaningful and timely input in the development
of regulatory proposals containing significant unfunded mandates.''
Today's rule does not create an unfunded Federal mandate on State,
local, or tribal governments. The rule does not impose any enforceable
duties on these entities. Accordingly, the requirements of section 1(a)
of Executive Order 12875 do not apply to this rule.
C. Executive Order 13084
Under Executive Order 13084, entitled Consultation and Coordination
with Indian Tribal Governments (63 FR 27655, May 19, 1998), EPA may not
issue a regulation that is not required by statute, that significantly
or uniquely affects the communities of Indian tribal governments, and
that imposes substantial direct compliance costs on those communities,
unless the Federal government provides the funds necessary to pay the
direct compliance costs incurred by the tribal governments. If the
mandate is unfunded, EPA must provide OMB, in a separately identified
section of the preamble to the rule, a description of the extent of
EPA's prior consultation with representatives of affected tribal
governments, a summary of the nature of their concerns, and a statement
supporting the need to issue the regulation. In addition, Executive
Order 13084 requires EPA to develop an effective process permitting
elected officials and other representatives of Indian tribal
governments ``to provide meaningful and timely input in the development
of regulatory policies on matters that significantly or uniquely affect
their communities.''
Today's rule does not significantly or uniquely affect the
communities of Indian tribal governments. This action does not involve
or impose any requirements that affect Indian tribes. Accordingly, the
requirements of section 3(b) of Executive Order 13084 do not apply to
this rule.
X. Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq. , as added by
the Small Business Regulatory Enforcement Fairness Act of 1996,
generally provides that before a rule may take effect, the Agency
promulgating the rule must submit a rule report, which includes a copy
of the rule, to each House of the Congress and 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 the rule in the Federal Register. This rule is not a
``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: May 14, 1999.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 321(q), 346(a) and 371.
2. Section 180.1206 is added to subpart D to read as follows:
Sec. 180.1206 Aspergillus flavus AF 36; Exemption from the requirement
of a tolerance.
Aspergillus flavus AF 36 is temporarily exempt from the requirement
of a tolerance in/on cotton when used on cotton in Arizona in
accordance with the Experimental Use Permit 69224-EUP-1. The temporary
exemption from the requirement of a tolerance will expire on December
30, 2000.
[FR Doc. 99-13192 Filed 5-25-99; 8:45 am]
BILLING CODE 6560-50-F
