[Federal Register Volume 66, Number 100 (Wednesday, May 23, 2001)]
[Rules and Regulations]
[Pages 28383-28386]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-12900]


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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301124; FRL-6781-7]
RIN 2070-AB78


Aspergillus flavus AF36; Extension of Temporary Exemption From 
the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation extends a temporary exemption from the 
requirement of a tolerance for residues of the biological Aspergillus 
flavus AF36, (A. flavus) a non-aflatoxin producing strain of A. flavus, 
on cotton when applied or used as aerial pre-bloom applications to 
cotton in specified counties of Arizona. The Interregional Research 
Project Number 4 (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, submitted an amended petition 
to EPA under the Federal Food, Drug, and Cosmetic Act, as amended by 
the Food Quality Protection Act of 1996 requesting the temporary 
exemption. This regulation eliminates the need to establish a maximum 
permissible level for residues of Aspergillus flavus AF36. The 
temporary tolerance exemption will expire on December 30, 2003.

DATES: This regulation is effective May 23, 2001. Objections and 
requests for hearings, identified by docket control number OPP-301124, 
must be received by EPA on or before July 23, 2001.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit III. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket control number OPP-301124 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Shanaz Bacchus, c/o Product 
Manager (PM) 90, Biopesticides and Pollution Prevention Division 
(7511C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: 703-308-8097; and e-mail 
address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural 
producer, food manufacturer, or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:

 
------------------------------------------------------------------------
                                                 Examples of Potentially
             Categories                 NAICS       Affected Entities
------------------------------------------------------------------------
Industry                                    111  Crop production
                                            112  Animal production
                                            311  Food manufacturing
                                          32532  Pesticide manufacturing
------------------------------------------------------------------------

    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

[[Page 28384]]

entities not listed in the table could also be affected. The North 
American Industrial Classification System (NAICS) codes have been 
provided to assist you and others in determining whether or not this 
action might apply to certain entities. If you have 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 Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/. A frequently updated electronic 
version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_180/Title_40/40cfr180_00.html, a beta site currently 
under development.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301124. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of May 26, 1999 (64 FR 28371) (FRL-6081-2), 
EPA issued a final rule pursuant to section 408 of the Federal Food, 
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the Food 
Quality Protection Act of 1996 (FQPA) (Public Law 104-170) establishing 
a temporary exemption from the requirement of a tolerance for residues 
of A. flavus AF36 on cotton grown in 5 counties in Arizona (40 CFR 
180.1206). This final rule included a summary of the Agency's 
assessment of the health effects data submitted in support of the 
extension of the temporary tolerance exemption. The temporary exemption 
from tolerance was extended until December 2001 (64 FR 35049, June 30, 
1999) (FRL-6087-3) to allow for passage of the treated commodities 
through the channels of trade.
    Comments submitted to the Agency regarding the use of this 
competitive fungal agent were by the cotton growers in the region who 
were all in favor of the extension of the exemption from the temporary 
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. No 
adverse effects were reported in the yearly annual reports of the 
Experimental Use Permit, and in some instances aflatoxin levels of 
cotton seed were reduced in treated cotton.
    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 use in residential settings.
    The fungal agent is applied prebloom to the soil of treated cotton 
fields. When conditions are appropriate, the AF 36 spores land on the 
cotton plant and germinate to displace the naturally occurring 
toxigenic strain. No adverse effects were reported in the annual 
reports which the registrant submitted as required in the EUP.
    This extension of the exemption from the requirement of a temporary 
tolerance is associated with an extension of an Experimental Use Permit 
(EUP, EPA Reg. No. 69224-EUP-1). This extension of the EUP will allow 
aerial application of A. flavus AF36 in the following counties of 
Arizona: Yuma (3,300 acres), Maricopa (13,150 acres), Mohave (1,700 
acres) and Pinal (1,850 acres). This final rule extends the temporary 
exemption from a tolerance for residues of Aspergillus flavus AF36 on 
cotton until December 30, 2003.
    Of the strains of A. flavus found naturally in Arizona, this 
atoxigenic strain comprises about 15% of the natural microbial 
population in the soil, as opposed to the predominant S or toxigenic S 
strain.
    Summaries of the toxicological profile and other relevant 
manufacturing and health effects data, to comply with the guideline 
requirements of the Food Quality Protection Act of 1996, were reported 
in the Federal Register publication of the final rule of May 26, 1999, 
extending the temporary tolerance exemption. Based on the previously 
submitted data outlined in the final rule, 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 this experimental use permit. This includes all 
anticipated dietary exposures and all other exposures for which there 
is reliable information.
    The Agency continues to require that the pesticide must not be 
applied within a boundary of 400 feet of residential areas, schools, 
daycare and health care facilities and hospitals to minimize exposure 
to human adults, infants and children.
    Data have been submitted to demonstrate that this strain excludes 
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.

[[Page 28385]]

 Furthermore, there is no expectation of cumulative effects with other 
pesticides, because this is the only registered experimental microbe in 
this genus.
    As in the earlier EUP, the Agency requires that applicators and 
other handlers must wear gloves, a dust/mist filtering respirator with 
NIOSH approval prefix N-95, R-95 or P-95, long sleeved shirt and long 
pants, and shoes plus socks to mitigate potential worker 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. Treated cotton and its by products 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 A. flavus 
isolate AF36 on cotton (40 CFR 180.1206) is currently in effect in 
conjunction with an Experimental Use Permit (61 FR 30235, June 14, 
1996, and extended to expire in December 2001) (FRL-5377-6).

III. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, 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. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA of 1996, EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) 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), as was provided in the old FFDCA sections 408 and 409. 
However, the period for filing objections is now 60 days, rather than 
30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket control number OPP-301124 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 july 23, 
2001.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). 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). 
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.
    Mail your written request to: Office of the Hearing Clerk (1900), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your request to the Office 
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., 
Washington, DC 20460. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    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 the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VIII.A., 
you should also send a copy of your request to the PIRIB for its 
inclusion in the official record that is described in Unit I.B.2. Mail 
your copies, identified by docket control number OPP-301124, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 
In person or by courier, bring a copy to the location of the PIRIB 
described in Unit I.B.2. You may also send an electronic copy of your 
request via e-mail to: [email protected]. Please use an ASCII file 
format and avoid 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 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    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).

IV. Regulatory Assessment Requirements

    This final rule extends a temporary exemption from the tolerance 
requirement under FFDCA section 408(d) 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

[[Page 28386]]

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) (Public Law 104-4). 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); 
or OMB review or any Agency action under Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997). 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). Since 
tolerances and exemptions that are established on the basis of a FIFRA 
section 18 petition under FFDCA section 408, 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. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled Federalism 
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by State and local officials in the development of regulatory policies 
that have federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4).
    For these same reasons, the Agency has determined that this rule 
does not have any ``tribal implications'' as described in Executive 
Order 13175, entitled Consultation and Coordination with Indian Tribal 
Governments (65 FR 67249, November 6, 2000). Executive Order 13175, 
requires EPA to develop an accountable process to ensure ``meaningful 
and timely input by tribal officials in the development of regulatory 
policies that have tribal implications.'' ``Policies that have tribal 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on one or more Indian tribes, on 
the relationship between the Federal government and the Indian tribes, 
or on the distribution of power and responsibilities between the 
Federal government and Indian tribes.'' This rule will not have 
substantial direct effects on tribal governments, on the relationship 
between the Federal government and Indian tribes, or on the 
distribution of power and responsibilities between the Federal 
government and Indian tribes, as specified in Executive Order 13175. 
Thus, Executive Order 13175 does not apply to this rule.''

V. 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 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: May 9, 2001.
Janet L. Anderson,
Director, Biopesticide 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 revised to read as follows:


Sec. 180.1206  Aspergillus flavus AF36.

    Aspergillus flavus AF36 is temporarily exempt from the requirement 
of a tolerance in or on cotton when used on cotton in Arizona in 
accordance with the Experimental Use Permit 69224-EUP-1. The temporary 
exemption from a tolerance will expire on December 30, 2003.
[FR Doc. 01-12900 Filed 5-22-01; 8:45 am]
BILLING CODE 6560-50-S