[Federal Register Volume 69, Number 125 (Wednesday, June 30, 2004)]
[Rules and Regulations]
[Pages 39341-39350]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-14609]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2004-0164; FRL-7364-2]


Aspergillus flavus NRRL 21882; Exemption from the Requirement of 
a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of the microbial active ingredient 
Aspergillus flavus NRRL 21882 on peanuts when applied/used in 
accordance with label directions. Circle One, One Arthur Street, PO Box 
28, Shellman, GA 39886-0028 submitted a petition to EPA under the 
Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food 
Quality Protection Act of 1996 (FQPA), 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 on peanuts.

DATES: This regulation is effective June 30, 2004. Objections and 
requests for hearings must be received on or before August 30, 2004.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit VIII. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under Docket 
ID number OPP-2004-0164. All documents in the docket are listed in the 
EDOCKET index at http://www.epa.gov/edocket. Although listed in the 
index, some information is not publicly available, i.e., 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 either electronically in 
EDOCKET or in hard copy at the Public Information and Records Integrity 
Branch (PIRIB), Rm. 119, Crystal Mall 2, 1921 Jefferson Davis 
Hwy., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays. The docket 
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Shanaz Bacchus, Biopesticides and 
Pollution Prevention Division (7511C), Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-8097; e-mail address: [email protected].

[[Page 39342]]

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. To determine 
whether you or your business may be affected by this action, you should 
carefully examine the applicability provisions. 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 and Other 
Related Information?

    In addition to using EDOCKET (http://www.epa.gov/edocket/), you may 
access this Federal Register document electronically through the EPA 
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 
is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.

II. Background and Statutory Findings

    In the  Federal Register of March 17, 2004, (69 FR 12659-12664) 
(FRL-7348-8), EPA issued a notice pursuant to section 408(d)(3) of the 
FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide 
tolerance petition (PP 4F6815) by Circle One, One Arthur Street, PO Box 
28, Shellman, GA 39886-0028. This notice included a summary of the 
petition prepared by the petitioner, Charlie Rose.
    The petition requested that 40 CFR part 180 be amended by 
establishing an exemption from the requirement of a tolerance for 
residues of Aspergillus flavus NRRL 21882 on peanuts.
     EPA received seven comments in response to the Notice of Filing. 
Six of those comments were from farmers who support the use of 
Aspergillus flavus NRRL 21882 to reduce aflatoxin contamination of 
peanuts. Among their comments in support of the pesticide, these 
farmers noted the tremendous cost, in excess of $25 million dollars per 
year, to manage aflatoxin contamination of peanuts. The Agency is 
working expeditiously to evaluate the data submitted to support 
registration of the active ingredient Aspergillus flavus NRRL 21882 and 
this Final Rule granting an exemption from the requirement of a 
tolerance is part of that process.
     The seventh comment raised a number of issues and concerns. First, 
the commentor objected to the publication of the applicant's data 
summaries submitted with the petition prior to EPA's evaluation of such 
data and viewed the Notice of Filing as an attempt to obtain approval 
with insufficient information. This commentor appears to misunderstand 
the nature and purpose of a Notice of Filing. Under section 408(d)(3) 
of the FFDCA, EPA is required to publish a notice of the filing of a 
petition seeking the establishment of a tolerance or an exemption from 
the requirement of a tolerance. That notice must contain an applicant-
prepared ``informative summary'' of the data, information, and 
arguments provided by the applicant in support of its petition. (See 
FFDCA sec. 408(d)(2)A)(i)(I)). The Notice of Filing is published in the 
Federal Register prior to the Agency's evaluation of the petition and 
the data submitted in support of that petition. Once EPA has evaluated 
the petition and all supporting data, EPA issues a final rule, such as 
this one, which includes EPA's assessment of the applicant's 
submissions, as they relate to dietary risk, and EPA's determination 
vis-a-vis the requested tolerance or tolerance exemption. The Notice of 
Filing, in and of itself, is not an indication of whether the sought 
tolerance or tolerance exemption will, in fact, be granted by the 
Agency.
     Second, the commentor objected to the applicant's animal test 
reports and the number and duration of the studies underlying those 
reports, and to the applicants' requests to waive data. With respect to 
the animal tests, the commentor also suggested that human cell testing 
or testing on humans should be done instead. EPA regulates pesticides 
according to peer-reviewed and publicly available guidelines that 
describe endpoints for human health risk assessment. Tests are 
conducted with the active ingredient or end-use product in surrogate 
animals, through various routes of administration (i.e., oral, dermal, 
pulmonary, etc.). Any effects seen are reported to the Agency, peer-
reviewed, and evaluated to determine whether the effects of the test 
material demonstrate infectivity, acute toxicity, or pathogenicity. 
While tests in some human cell-lines are available, they may not always 
be applicable, and may not assist the Agency in making as accurate an 
assessment of the hazards and risks posed by the use of the pesticide 
as can be done with surrogate animal tests. Both positive and adverse 
effects are reported by the applicant so that toxicological concerns 
for human health and environmental risk assessment can be identified 
and mitigated according to sound scientific practice and taking into 
account the exposure levels and risks associated with the pesticide. If 
further testing is required to fully evaluate any hazard and risks 
posed by the test material under proposed use patterns, the registrant 
must submit the appropriate additional data to satisfy EPA's published 
guideline requirements. EPA does not deviate from these guidelines 
without good reason, and does so for data waiver requests only when 
sound scientific consensus on the provided data waiver rationale is 
reached. In this case, and as discussed more thoroughly below (see Unit 
III.5. and 6.), EPA granted the requested waivers only after 
determining that the rationales provided in support of those waiver 
requests were acceptable.
    Third, the commentor asserted that dermal sensitivity to this 
product is already known to exist, and that more of it is not needed. 
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 to commercial agricultural fields in 
accordance with the requirements of the applicable Worker Protection 
Standards. Workers are protected from potential dermal and inhalation 
exposure to the pesticide by appropriate Personal Protective Equipment 
(PPE) as required on the label (see Unit III.4.). Pesticide drift is 
not expected from the application 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, and occupational 
exposure is mitigated (see Unit IV.B).
    Finally, the commentor objected to the statement by the applicant 
that this application is not likely to increase the

[[Page 39343]]

natural concentration of Aspergillus in water, and thus is not 
considered to be a risk for drinking water. As discussed below, EPA's 
evaluation of the acute oral studies conducted in rodents indicate no 
toxicity or pathogenicity via oral exposure to this pesticide, which 
includes exposure via drinking water (see Unit III.). Furthermore, this 
pesticide is not applied directly to water, but to the soil in drought 
ridden regions where accumulation in water is not likely to occur. In 
addition, Aspergillus flavus NRRL 21882 is expected to displace native 
aflatoxin-producing Aspergillus fungi at the sites of application, thus 
reducing the potential hazards posed by these ubiquitous toxigenic 
fungi. For a more complete discussion of EPA's findings regarding 
Aspergillus flavus NRRL 21882 and drinking water, see Unit IV.A.2. 
below.
    Having thus addressed the comments received in response to the 
Notice of Filing and the summary of the petition contained therein 
seeking an exemption from the requirement of a tolerance for 
Aspergillus flavus NRRL 21882, the remainder of this Final Rule 
summarizes EPA's review and consideration of that tolerance exemption 
request. The Biopesticide and Pollution Prevention Division (BPPD) 
review documents referred to below are discussed in more detail in the 
Biopesticide Registration Action Document (BRAD) which will be made 
available in the docket.
    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) of the 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), 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), 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 the 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 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.
    Aspergillus flavus NRRL 21882 is a non-aflatoxin-producing fungal 
active ingredient that will be used to displace the ubiquitous 
Aspergillus flavus group of microbes, many of which can produce 
aflatoxin, a potent carcinogen. The pesticide is proposed for a single 
ground application once a year at the pre-pegging stage of peanuts to 
displace aflatoxin-producing strains of Aspergillus flavus from that 
food commodity. Summaries of eight field trials reported to the Agency 
support the claim that Aspergillus flavus NRRL 21882 reduces aflatoxin 
contamination in field-grown peanuts. Aflatoxin was measured in shelled 
and unshelled peanuts by High Pressure Liquid Chromatography (HPLC). 
Five of the trials used the active ingredient in combination with 
another Aspergillus flavus strain and did not use the product label 
application rate. The remaining three trials, using Aspergillus flavus 
NRRL 21882 alone at rates as required by the guidelines or Agency, 
reduced the aflatoxin content of treated peanuts by 71% to 98%, 
compared to that of untreated controls (Master Record Identification 
(MRID) Number 46196805, BPPD Data Evaluation Record (DER) dated May 5, 
2004, hereinafter referred to as ``BPPD DER 05/05/04;'' also Unit 
VII.D.). These multiyear efficacy studies of small plot field trials 
demonstrate that aflatoxin is reduced by 71% to 98% in peanuts treated 
with Aspergillus flavus NRRL 21882 (MRID 46196805; BPPD DER 05/05/
2004).
    Aspergillus flavus NRRL 21882 is not vegetatively compatible with 
known aflatoxin-producing strains of Aspergillus flavus, and thus, may 
not exchange genetic material with the latter. Other members of the 
Aspergillus group have been domesticated and are used to provide 
products for human consumption. Examples include Aspergillus niger as a 
source of alpha-galactosidase enzyme found in Beano, and Aspergillus 
oryzae as used for production of soy sauce and miso. Aspergillus flavus 
NRRL 21882 is identified by vegetative compatibility group (VCG) assays 
and characterized as non-aflatoxin-producing by standard thin layer 
chromatography (TLC) and HPLC procedures.
    Product characterization data submitted in January 2004, for 
Aspergillus flavus NRRL 21882 confirmed the absence of aflatoxin 
metabolites (B1, B2, G1, and G2), and cyclopiazonic acid (CPA) MRID 
46196801, BPPD DER dated 05/06/2004a, hereinafter referred to as ``BPPD 
DER 05/06/2004a''). In addition, the technical grade active ingredient 
(TGAI) manufacturer routinely conducts standard microbiological assays 
on Aspergillus flavus NRRL 21882 to monitor for bacterial and fungal 
human pathogens. Starting materials for End-use Product manufacture are 
also routinely analysed using appropriate quality assurance and quality 
control methods. Analytical methods exist for batches of Aspergillus 
flavus NRRL 21882 conidia to assay for potential aflatoxins, 
metabolites, CPA, bacterial contaminants, and bacterial pathogens, and 
are acceptable (BPPD DER, 05/06/2004a). The applicant must maintain 
appropriate quality assurance and quality control measures to ascertain 
product integrity and quality. Any batch of the pesticide with 
aflatoxins, unintentional metabolites, human pathogens or other 
contaminants above regulatory levels must be destroyed, as required for 
quality control.
     EPA analyzes the data submitted by an applicant to determine the 
risks from aggregate exposure to pesticide residues. The following 
discussion of the evaluations of the submitted studies and information 
for Aspergillus flavus NRRL 21882 indicates that exposure to the 
pesticide is not likely to be greater than that which occurs normally 
to other ubiquitous Aspergillus flavus strains. As discussed below, 
reviews of the data submitted by the applicant indicate no toxicity, 
infectivity or pathogenicity in mammalian acute oral and pulmonary 
studies using Aspergillus flavus NRRL 21882 as test material. Thus, for 
the purposes of this tolerance exemption

[[Page 39344]]

action, EPA has concluded that there is a reasonable certainty that no 
harm to human adults, infants or children will result from aggregate 
exposure to residues of Aspergillus flavus NRRL 21882, including all 
anticipated dietary exposures and all other exposures for which there 
is reliable information.
    1. Acute oral toxicity/pathogenicity (MRID 45884002; OPPTS 
885.3050; Guideline 152-30). In an acute oral toxicity study conducted 
in male and female rats for 14 days, the test material contained 50% 
Aspergillus flavus NRRL 21882, and 50% of another Aspergillus strain. 
The male and female LD50 for this test material was greater 
than 5,000 milligrams per kilogram (mg/per/kg). There were no 
mortalities, or gross abnormalities, upon necropsy. Anogenital 
staining, soft feces, and/or colored material around the nose was 
observed in some animals to Day 2. This study was considered acceptable 
for the material tested, which contained 50% Aspergillus flavus NRRL 
21882 (MRID 45884002; BPPD Data Evaluation Record dated July 16, 2003, 
hereinafter referred to as BPPD DER 07/16/2003). A further test with 
the TGAI was required to fulfil Agency guideline requirements for the 
proposed use of products containing Aspergillus flavus NRRL 21882 as 
the active ingredient.
    In a subsequent study, 23 male and 23 female rats were treated by 
gavage with the TGAI, Aspergillus flavus NRRL 21882, and observed for 
22 days (MRID 46196802; BPPD DER dated May 06, 2004b, hereinafter 
referred to as BPPD DER 05/06/2004b). Body weights were recorded on 
days 1 (prior to dosing), 4, 8, 15, and 22. The test animals were 
observed for clinical signs of toxicity shortly after, and then hourly 
after dosing and twice on subsequent days. Fecal samples from Group 4 
rats were collected on days 4, 8, 15, and 22. The animals were 
sacrificed and necropsied. Recovery of viable Aspergillus flavus NRRL 
21882 from blood, organs, intestinal contents, and feces was determined 
by serial decimal dilution, plating and incubation at 30-35 [deg]C for 
a minimum of 48 hours.
    All animals gained weight during the study. No treatment-related 
clinical signs were observed. No abnormal findings were noted at any 
necropsy interval. Low numbers of viable Aspergillus flavus NRRL 21882 
were recovered from the intestinal contents (stomach, small intestine, 
or cecum) of Group 1 animals on day 4. There was one male in Group 2 
that had low numbers of viable test organism in the small intestine and 
cecum on day 8. Clearance from feces and cecum was established at day 
14. Low numbers of viable Aspergillus flavus NRRL 21882 were found in 
the feces from Group 4 treated rats on day 4. No test organisms were 
detected in any organ or blood from any group. Under these conditions, 
insufficient viable test organisms were recovered from the test samples 
to determine rate of clearance. Aspergillus flavus NRRL 21882 does not 
appear to be toxic, infective, and/or pathogenic in rats, when dosed 
orally at 2.35-3.80 x 108 CFU/animal. The pesticide was 
considered Toxicity Category IV. No further study is required for this 
guideline for the proposed use of the active ingredient (BPPD DER 05 /
06/2004b) .
    2. Acute pulmonary toxicity/pathogenicity (MRID 45884003; OPPTS 
885.3150). In a 22-day acute pulmonary toxicity/pathogenicity study 
(MRID 45884003), young adult rats (17 per sex) were administered a 
suspension of Aspergillus flavus NRRL 21882 in a single dose by 
intratracheal instillation at 5.77 - 7.20 x 107 CFU per 
animal. No mortalities or evidence of pathogenicity due to Aspergillus 
flavus NRRL 21882 was seen. Transient respiratory signs (rales and/or 
irregular respiration) were observed in some treated rats up to 1 hour 
post-dosing. A single mortality on Day 2 probably was not due to 
Aspergillus flavus NRRL 21882 and may have been caused by the mechanism 
of dosing. There was no evidence of treatment-related effects on body 
weight or temperature, or that Aspergillus flavus NRRL 21882 
proliferated or was infective in treated rats. Viable Aspergillus 
flavus NRRL 21882 was recovered in lung tissue in five of six animals 
sacrificed 1 hour post-dosing (102 - 106 CFU per 
g tissue) and in the lungs of the single rat that died on Day 2 
(104 CFU per gram). No viable organisms were found in any 
other tissues or organs examined during the remainder of the study. 
Aspergillus flavus NRRL 21882 was reported in feces of two of five 
males studied (12 and 357 CFU per gram) and 3 of 5 females studied (10, 
77, and 64,400 CFU per gram) only on Day 4 and this was thought to 
occur from active muco-ciliary lung clearance of Aspergillus flavus 
NRRL 21882. The rate of clearance of viable Aspergillus flavus NRRL 
21882 was not calculated because no viable organisms were recovered in 
any sample past the day of dosing, except from lungs of a single 
mortality on day 2. This study was considered acceptable and the 
pulmonary LD50 is greater than 5.77 - 7.20 x 107 
CFU per animal (BPPD DER, 07/16/2003). No further study is required for 
this guideline.
    3.  Acute inhalation (MRID 45884003; OPPTS 885.3150; Guideline 152-
32). Based on the low toxicity potential of the acute pulmonary 
toxicity/pathogenicity test described above (MRID 45884003; OPPTS 
885.3150, BPPD DER, 07/16/2003), an acute inhalation study was not 
required, per 40 CFR 158.740(c)(i). The granular End-use Product (EP) 
consists mainly of hulled barley (approximately 96%), which are larger 
than 10 micron respirable particles. While the Aspergillus flavus NRRL 
21882 conidia may be less than 10 micron in size, they are formulated 
into the EP with food-grade inerts which function to adhere the conidia 
to the hulled barley. The food grade inerts are also not likely to pose 
an inhalation hazard based on their particle size and adherence to the 
carrier. Furthermore, this pesticide is to be applied once per season 
to commercial and agricultural fields, and not in residential settings. 
The low rates of application to the soil and the granular nature of the 
pesticide minimize non-occupational (as well as occupational) 
inhalation exposure, as discussed below. Nevertheless, a dust/mist 
filtering respirator with NIOSH prefix N-95, R-95 or P-95 is required 
to mitigate against occupational exposure because of the microbial 
nature of the pesticide.
    4. Intravenous, intracerebral, intraperitoneal injection (OPPTS 
Harmonized Guideline 885.3200; MRIDs 45884004, 46223901; Guideline 152-
33). In an injection toxicity/pathogenicity study, young adult rats 
(three per sex) were given an intraperitoneal injection with a single 
dose-suspension of Aspergillus flavus NRRL 21882, suspended in a 
solution containing Tween, at approximately 107 CFU per 
animal. All animals treated with the active substance died or were 
sacrificed for humane reasons on Day 5 - 6 when treated animals showed 
severe clinical signs (i.e. piloerection, hunched posture, abnormal 
gait or reduced body tone and underactive behavior) with lack of 
pyrogenic response. Similar post-mortem findings were observed in 
animals treated with either heat-inactivated or live Aspergillus flavus 
NRRL 21882 (i.e., white nodules and adhesions on a number of organs). 
High levels (greater than 10,000 CFU per g) of Aspergillus flavus NRRL 
21882 were found in the spleen or liver of animals that died naturally 
and from the sole animal sacrificed on day 5. The LD50 for 
the test material was considered less than 107 CFU per 
animal (MRID 45884004; BPPD DER 07/16/2003). This study was considered 
supplemental,

[[Page 39345]]

with some effects probably due to the presence of Tween in the test 
dose. The claimed lack of infectivity in moribund or deceased rats is 
inconclusive due to an unknown etiology.
    A second study, submitted in January 2004 (MRID 46223901), was 
conducted with 22 male and 22 female rats. Treated groups received 1.13 
- 1.47 x 107 CFU/rat Aspergillus flavus NRRL 21882 without 
Tween 80, by intraperitoneal injection (i.e. directly into the 
abdominal cavity of the animal to demonstrate the worst case scenario 
under which exposure may occur). One of the control groups received a 
sterile culture filtrate and other controls received either autoclaved 
test material, or no treatment. Animals were observed over a 22 day 
period. No test organisms were detected in any samples from the 
controls. Viable Aspergillus flavus NRRL 21882 was below detection (<10 
CFU/mL) in blood at all sample times. At 1 hour after dosing, the test 
organism was detected in the kidneys, spleen, liver, heart, lungs, 
mesenteric lymph nodes and intestinal contents of treated rats, but was 
below detection (<10 CFU/mL) in the brain. By day 4, viable counts were 
still high in the spleen but decreased in other organs, while low 
levels of viable Aspergillus flavus NRRL 21882 were found in the brain 
of 3 out of 6 rats. By day 8, clearance was observed from all tissues 
in the males, and from most tissues except the spleen and mesenteric 
lymph nodes of females, which cleared by day 22. Clearance from 
intestinal contents and feces occurred in males prior to day 8, and in 
females by day 22. After the 22 day period, clearance had occurred from 
all tissues and samples (MRID 46223901).
    One female treated with viable Aspergillus flavus NRRL 21882 was 
sacrificed on day 7 because of severe clinical effects. No unscheduled 
deaths were observed in any other group. Lower overall mean body weight 
gains in one group were not considered due to the viable test organism, 
but may have been attributable to experimental fecal sampling 
procedures only performed on this group (BPPD Review dated May 6, 
2004a). The treated female who was euthanized on day 7 showed head 
tilting and leaning with an abnormal gait and circling. Other clinical 
signs included head tilting/leaning in two animals, repetitive head 
turning in one animal and limited use of rear limbs in one animal. The 
study director concluded that head tilting and circling in one male, 
and head tilting in one female, were probably related to the viable 
test organism (BPPD Review dated May 6, 2004a). Clinical signs did not 
clear from 3 of 6 remaining animals at study termination on day 22. 
Based on this study, which was considered acceptable by the Agency, 
Aspergillus flavus NRRL 21882 was considered infective and pathogenic 
to rats by intraperitoneal administration with an IP LD50 > 
1.13 - 1.51 x 107 CFU/rat.
    While the results of this IP test suggest potential infectivity via 
serious injury as reflected by an intraperitoneal route of exposure, it 
is important to note that clearance was observed from all tissues of 
surviving animals in this IP study, a finding consistent with all the 
other toxicology studies reported above. More importantly, the results 
of this IP test, while relevant to issues of occupational exposure, are 
not relevant to this tolerance exemption determination, which focuses 
on non-occupational exposure. Indeed, the acute oral studies reported 
above, which are directly relevant to an analysis of dietary, non-
occupational exposure, indicate no infectivity or pathogenicity. In 
addition, if the pesticide is used as labeled (approximately 1 gram 
active ingredient per acre), much lower levels of non-occupational 
exposure are expected when peanuts are consumed than can be 
extrapolated from the IP test, in which the test substance was 
administered directly into the abdominal cavity at a rate of 
107 CFU/animal. Moreover, the pesticide is not to be applied 
to residential areas, but rather only to commercial peanut fields, and 
any potential pesticide residues on treated peanuts are further 
mitigated by processing as described in Unit IV. Furthermore, the 
inerts are food grade and cause the active ingredient to adhere to the 
carrier (hulled barley), thus minimizing pesticide drift or transfer of 
residues. Finally, and as mentioned previously, Aspergillus flavus 
species occur naturally in the environment and non-occupational or 
residential exposures are expected to be no greater than that expected 
from background Aspergillus flavus levels. All of these factors and 
considerations minimize non-occupational exposure and allow the Agency 
to conclude that the dietary risks posed by the use of this pesticide 
are likely to be minimal and that there is a reasonable certainty that 
no harm will result from use of this microbial agent.
    It should be clarified, however, that in connection with the 
Agency's consideration of Aspergillus flavus NRRL 21882 for purposes of 
registration, as distinct from this tolerance exemption action, the 
Agency has considered the worst case scenario in which similar types of 
IP occupational exposures may occur. The relevance of this IP test is 
to seriously injured workers or to those who may come in contact with 
the pesticide through a similar route of exposure intraperitoneally. As 
previously stated, the granular pesticide is applied at a very low rate 
to the soil with little or no pesticide drift. Worker exposure is 
minimized by the use of PPE that includes long sleeve shirt, long 
pants, shoes, socks, waterproof gloves, eye protection and an 
appropriate dust/mist filtering respirator with the NIOSH prefix N-95, 
P-95, or R-95. Early-entry workers, engaged in post-application 
activities, must wear this PPE when entering treated fields during the 
4 hour Restricted-Entry Interval (REI).
    5. Hypersensitivity incidents (MRID 46196804; OPPTS Harmonized 
Guideline 870.3400; Guideline 152-37). Personnel at the USDA 
Agricultural Research Service National Peanut Research Laboratory have 
been working with different strains of Aspergillus flavus since 1987 
and have performed numerous studies in laboratory and field settings 
with the active ingredient, Aspergillus flavus NRRL 21882, with no 
reported adverse effects. In addition, there are no data that suggest 
this strain is more or less likely to induce hypersensitivity than 
other naturally occurring strains of Aspergillus flavus (MRID 46196804; 
BPPD DER 05/06/2004c). However, in the future and in order to comply 
with FIFRA section 6(a)(2) requirements (see also 40 CFR 159.152), any 
incident of hypersensitivity associated with the use of this pesticide 
must be reported to the Agency.
    6. Data waivers. i. A request was submitted to waive data for the 
acute oral toxicity/pathogenicity study for the EP, afla-guardT (OPPTS 
885.3050; Guideline 152-30). The waiver request was based on the 
acceptable results of the acute oral toxicity/pathogenicity studies 
conducted with the TGAI (summarized above) and the nature of the 
inerts, which are exempt from the requirement of a tolerance according 
to 40 CFR 180.950(a) and 40 CFR 180.1001 (redesignated as 40 CFR 
180.900, 180.905, 180.910, 180.920, and 180.930, April 28, 2004, 69 FR 
23113). Since the EP contains 0.01% of the TGAI, this rationale was 
acceptable to the Agency and the data requirement for the acute oral 
toxicity/pathogenicity study for the EP was waived (BPPD Memorandum, 
May 28, 2004). In addition, as discussed above, an acute oral study 
conducted with test material containing 50% Aspergillus flavus NRRL 
21882 (MRID 45884002; BPPD DER 07/16/2003) and the same inerts as the 
test material was considered acceptable. No further data

[[Page 39346]]

are required for this guideline for the proposed use of the EP.
    ii. Data waivers were also requested for the following studies for 
both the TGAI and the EP:
    a. Acute dermal toxicity/pathogenicity (OPPTS Harmonized Guideline 
885.3100; Guideline 152-31).
    b. Primary dermal irritation (OPPTS Harmonized Guideline 870.2500; 
Guideline 152-34).
    c. Primary eye irritation (OPPTS Harmonized Guideline 870.2400; 
Guideline 152-35).
    d. Hypersensitivity Study (OPPTS Harmonized Guideline 870.3400; 
Guideline 152-37).
    e. Immune Response (OPPTS Harmonized Guideline 880.3800; Guideline 
152-38).
    Application of the EP, hulled barley inoculated with Aspergillus 
flavus NRRL 21882, for the guideline tests to study primary dermal 
irritation for the EP is impractical. Furthermore, non-occupational 
dermal or inhalation exposure, or exposures via any of the routes 
covered by the guideline studies listed directly above, are expected to 
be no greater than that which occurs naturally for the following 
reasons. In mixing/loading and application experiments, spores of the 
pesticide are not released from the carrier and did not increase in the 
air space (MRID 46196804; BPPD DER dated May 06, 2004c, hereinafter 
referred to as BPPD DER 06/06/2004c). In addition, data from an 
unpublished study showed that the total level of Aspergillus strains in 
the soil increases after product application, but then declines and 
stabilizes, and that the total amount of Aspergillus strains in the 
crop is unaffected (MRID 46196804; BPPD DER 06/06/2004c. Thus, levels 
of Aspergillus strains are not expected to be greater than those which 
normally and naturally exist as a result of treatment of peanut fields 
with this pesticide.
    Data from the toxicology tests reported above indicate no toxicity 
or pathogenicity when the active ingredient is administered orally or 
via the pulmonary route. And while there is the potential for 
infectivity or pathogenicity after intraperitoneal injection, that 
study also demonstrates clearance of the test organism from all tissue 
samples by the end of the study. Results from these supporting 
toxicology tests indicate that test mammalian immune systems can clear 
the organism (see Unit III.1. and 2.). In addition, no adverse effects 
were reported by workers or researchers who handled the active 
ingredient during the experimental phase. Moreover, the pesticide is 
applied at a low rate of approximately 0.9 gram to 1 gram active 
ingredient per acre once during the growing season, and the use of PPE 
will protect workers from exposure to the pesticide (see Unit III.3.). 
Based on these considerations, the justifications in support of the 
request to waive data for acute dermal toxicity/pathogenicity, primary 
dermal irritation, the hypersensitivity study, and immune response were 
acceptable (BPPD DER 05/06/2004c).
    The rationale for the request to waive data for the primary eye 
irritation study was supplemental but upgradeable. The EP is applied 
once during the season at approximately 1 gram of active ingredient per 
acre, and drift is expected to be minimal because of the adherence of 
the pesticide to the carrier. Provided eye protective equipment to 
mitigate eye exposure is on the label for the proposed use, this data 
waiver request is granted. Additional data or justification must be 
submitted to meet Agency guideline requirements, should the applicant 
wish to amend the registration to remove PPE for eye protection from 
the label.
    7. Subchronic, chronic toxicity and oncogenicity, and residue data. 
Based on the data generated in accordance with the Tier I data 
requirements set forth in 40 CFR 158.740(c), the Tier II and Tier III 
data requirements were not triggered and, therefore, not required in 
connection with this action. In addition, because the Tier II and Tier 
III data requirements were not required, the residue data requirements 
set forth in 40 CFR 158.740(b) also were not required.

IV. 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).

A. Dietary Exposure

    1. Food. As discussed above, Aspergillus flavus NRRL 21882 is 
neither toxic nor infective as determined by studies in rats, when 
dosed orally at 2.35 - 3.80 x 108 CFU/animal (MRID 46196802; 
BPPD DER 05/06/2004). All known uses of peanuts for food use require 
roasting, shelling, or blanching. Residues of the active ingredient, 
Aspergillus flavus NRRL 21882, are not likely to survive these methods. 
In addition, the fungal active ingredient and potential metabolites are 
not likely to separate into peanut oil due to the high heat and 
solvents used in processing. Thus, transfer of viable residues of 
Aspergillus flavus NRRL 21882 via treated peanuts is not expected.
    Aflatoxins, potential metabolites associated with some strains of 
Aspergillus flavus, are not produced by this active ingredient. Indeed, 
as discussed above (Unit III.), field studies demonstrate that 
Aspergillus flavus NRRL 21882 actually reduced the aflatoxin content of 
treated peanuts by 71% to 98%, compared to that of untreated controls 
(MRID 46196805; BPPD DER 05/06/2004). Should any potential 
contamination by aflatoxin occur through use of this pesticide, a 
safety net already exists in that treated commodities for human and 
animal consumption must meet aflatoxin regulatory levels set by the 
USDA and the Food and Drug Administration (FDA). The processing methods 
mentioned above are also measures used in the industry to mitigate 
against the potential for aflatoxin contamination.
     As mentioned above, neither the active ingredient nor its 
potential metabolites are expected to separate out in peanut oil during 
production. The residues of the active ingredient and its potential 
metabolites on peanut hay are not expected to be different in the 
treated fields than in untreated fields. These data support the claim 
that dietary exposure to treated peanuts is not likely to increase the 
levels of aflatoxins in treated commodities, but rather to reduce 
exposure to those potent liver carcinogens. Finally, as previously 
described, an acute oral study demonstrates no toxic or pathogenic 
effects when rats are treated with the fungal active ingredient by oral 
gavage (Unit III.1.).
    2. Drinking water exposure. Exposure to Aspergillus flavus NRRL 
21882 in drinking water is not likely to be greater than current/
existing exposures to Aspergillus flavus strains generally. Potential 
risks via exposure to drinking water or runoff are adequately mitigated 
by, among other things, percolation through soil. The pesticide is to 
be applied to drought ridden areas to decrease the proliferation of the 
aflatoxin-producing strains which they displace. It is not to be 
directly applied to crops grown in water, and is not likely to 
accumulate in drinking water, if used as labeled. Thus, exposure via 
drinking water from the proposed use of this non-aflatoxin-producing 
strain of Aspergillus flavus is not likely to pose any incremental risk 
to adult humans, infants and children. In fact, displacement of the 
toxigenic strains of

[[Page 39347]]

Aspergillus flavus by this non-aflatoxin-producing strain may decrease 
exposure and risk to aflatoxin, a potent liver carcinogen.

B. Other Non-Occupational Exposure

    Non-occupational exposure is not likely to be greater than that 
which normally exists to the naturally occurring Aspergillus flavus 
species as discussed below.
    1. Dermal exposure. Potential non-occupational dermal exposure to 
Aspergillus flavus NRRL 21882 is unlikely because the use sites are 
commercial and agricultural, not residential, and because of the 
granular nature of the pesticide, which minimizes pesticide drift. As 
discussed earlier (see Unit III.), lack of hypersensitivity incidents, 
low application rates, and the return of levels of Aspergillus flavus 
to background levels shortly after germination, leads EPA to conclude 
that this pesticide poses minimal risk to human populations via non-
occupational dermal exposure, which exposure is expected to be no 
greater than the existing exposure to Aspergillus flavus at current 
levels.
    2. Inhalation exposure. Non-occupational inhalation exposure is not 
likely to pose a hazard. This determination is based on the pulmonary 
study which demonstrated that the pesticidal active ingredient is 
neither toxic nor infective to mammals when instilled into rats 
intratracheally (see Unit III.2., above). As discussed above, pesticide 
drift is expected to be minimal based on the granular nature of the 
pesticide, and on a formulation in which the active ingredient is 
expected to adhere to the carrier, primarily hulled barley. In 
addition, the low application rate (approximately or less than 0.002 
pound or 1 gram active ingredient per acre) to the commercial and 
agricultural crop, peanut, and the method of soil application suggest 
minimal exposure potential. The low pulmonary and oral toxicity/
pathogenicity potential, indicate that non-occupational inhalation 
exposure and risk are likely to be no greater than that which normally 
exists.
    Furthermore, Aspergillus species occur naturally in the environment 
and the application of this pesticide is expected to displace the 
aflatoxin-producing strains of the fungi, thus decreasing risks posed 
by the public health hazard, aflatoxins.

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 or pathogenic 
to humans. Another non-aflatoxin-producing strain, Aspergillus flavus 
AF36, is conditionally registered for use on cotton, but not on 
peanuts. There are no other registered pesticide products containing 
Aspergillus flavus NRRL 21882, and other Aspergillus flavus strains 
abound naturally in the environment. Moreover, the displacement of the 
aflatoxin-producing strain of Aspergillus flavus by Aspergillus flavus 
NRRL 21882 may reduce aflatoxin contamination of peanuts. Based on the 
low toxicity potential of Aspergillus flavus NRRL 21882, the fact that 
it is non-aflatoxigenic, and the safety net already in place to monitor 
food/feed commodities for aflatoxins (see Unit IV.A.1.), no cumulative 
or incremental effect is expected from the use of Aspergillus flavus 
NRRL 21882 on peanuts.

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

    There is reasonable certainty that no harm will result to the U.S. 
population, including infants and children, from aggregate exposures to 
residues of Aspergillus flavus NRRL 21882, as a result of its use as an 
antifungal agent on peanuts. 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 on peanuts 
via dietary exposure since the organism is non-toxic and non-pathogenic 
to animals and humans. The Agency 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). Moreover, non-occupational inhalation or dermal 
exposure is expected to be no greater than that which currently exists 
(see Units IV. and V.).
    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 on toxicity 
and exposure, unless EPA determines that a different margin of exposure 
(safety) will be safe for infants and children. Margins of exposure 
(safety), which are often referred to as uncertainty factors, are 
incorporated into EPA risk assessment either directly, or through the 
use of a margin of exposure analysis, or by using uncertainty (safety) 
factors in calculating a dose level that poses no appreciable risk. In 
this instance, based on all the available information (as discussed in 
detail above), the Agency concludes that the fungus, Aspergillus flavus 
NRRL 21882, 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 NRRL 21882 is used as labeled, 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

    EPA is required under section 408(p) of the FFDCA, as amended by 
FQPA, to develop a screening program to determine whether certain 
substances (including all pesticide active and other ingredients) ``may 
have an effect in humans that is similar to an effect produced by a 
naturally-occurring estrogen, or other such endocrine effects as the 
Administrator may designate.'' Following the recommendations of its 
Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC), 
EPA determined that there was scientific basis for including, as part 
of the program, the androgen-and thyroid systems, in addition to the 
estrogen hormone system. EPA also adopted EDSTAC's recommendation that 
the program include evaluations of potential effects in wildlife. For 
pesticide chemicals, EPA will use FIFRA and, to the extent that effects 
in wildlife may help determine whether a substance may have an effect 
in humans, FFDCA authority, to require the wildlife evaluations. As the 
science develops and resources allow, screening of additional hormone 
systems may be added to the Endocrine Disruptor Screening Program 
(EDSP).
    At this time, the Agency is not requiring information on the 
endocrine effects of this active ingredient, Aspergillus flavus NRRL 
21882. The Agency has considered, among other relevant factors, 
available information concerning whether the microorganism

[[Page 39348]]

may have an effect in humans similar to an effect produced by a 
naturally occurring estrogen or other endocrine effects. There is no 
known metabolite that acts as an ``endocrine disrupter'' produced by 
this microorganism. The submitted toxicity/infectivity or pathogenicity 
studies in the rodent (required for microbial pesticides) indicate 
that, following oral and pulmonary routes of exposure, the immune 
system is still intact and able to process and clear the active 
ingredient (see Unit III.). In addition, based on the low potential 
exposure level associated with the proposed single, seasonal, soil 
application of the pesticide at the pre-pegging stage of peanuts, the 
Agency expects no adverse effects to the endocrine or immune systems. 
Thus, there is no impact via endocrine-related effects on the Agency's 
safety finding set forth in this Final Rule for Aspergillus flavus NRRL 
21882.

B. Analytical Method(s)

     Aspergillus flavus NRRL 21882 occurs naturally in the soil and may 
be associated with peanuts regardless of pesticide treatment. Thus, 
there is a great likelihood of prior exposure for most, if not all, 
individuals and the increase in exposure due to this proposed microbial 
pesticide would be negligible. In addition, it likely is not possible 
to differentiate between the naturally occurring residues of 
Aspergillus flavus NRRL 21882 and those residues attributable to 
Aspergillus flavus NRRL 21882, the pesticide. Moreover, the acute oral 
studies discussed above demonstrate that the active ingredient does not 
pose a dietary risk. For these reasons, the Agency has concluded that 
an analytical method to detect residues of this pesticide on peanuts 
for enforcement purposes is not needed. Treated peanut food/feed 
commodities, however, must meet the requirements for aflatoxins and 
metabolites as regulated by the FDA and the USDA.
    Nevertheless, the Agency has concluded that for analysis of the 
pesticide itself, the methods discussed above (see Unit III.) are 
acceptable for enforcement purposes for product identity of Aspergillus 
flavus NRRL 21882 (VCG analysis) and its metabolites (TLC and HPLC). 
VCG analysis and nutrient utilization tests are used to screen starter 
cultures to identify the non-aflatoxin-producing Aspergillus flavus 
NRRL 21882 strain. Starter cultures of Aspergillus flavus NRRL 21882 
are also selected on the basis of the lack of aflatoxin as monitored by 
standard thin layer chromatography (TLC) and HPLC procedures. Other 
appropriate methods are required for quality control to assure product 
characterization, the control of human pathogens and other 
unintentional metabolites or ingredients within regulatory limits, and 
to ascertain storage stability and viability of the pesticidal active 
ingredient.

C. Codex Maximum Residue Level

    There is no Codex maximum residue level for residues of Aspergillus 
flavus NRRL 21882.

D. Efficacy Data (MRID 46196805)

    PR Notice 2002-1 lists aflatoxin as a public health hazard, for 
which product performance or efficacy data are required according to 40 
CFR 158.202(i). To demonstrate that this pesticide may reduce 
aflatoxin-producing strains and does not increase Aspergillus flavus 
populations above background levels, the applicant provided product 
performance or efficacy data from multiple years of studies monitoring 
peanuts and its byproducts. Aflatoxin, one of the most potent human 
carcinogens, is the metabolite of concern produced by the target pest, 
aflatoxin-producing strains of Aspergillus flavus. As such, the Agency 
considers aflatoxin a public health hazard. In the drought-ridden soils 
of peanut-producing areas, especially in the dry regions, the 
aflatoxin-producing strains are prominent. Few alternatives, if any, 
exist to displace aflatoxin-producing Aspergillus flavus strains from 
peanuts and other crops. Costly irrigation, or treating peanuts by 
roasting, or blanching or processing peanuts into peanut oil are among 
the methods used to decrease the effects of aflatoxin-producing strains 
of Aspergillus flavus on peanuts. Aspergillus flavus NRRL 21882 is 
proposed to displace toxigenic Aspergillus flavus strains that are 
present and colonize the peanut during pegging or below ground 
(possibly by vector transmission) if conditions favorable to infection 
are present during the growing season - namely drought conditions 
without sufficient irrigation or presence of nematode or insect vectors 
that penetrate the peanut shell. The applicant has provided product 
performance data to demonstrate the efficacy of the pesticide during 
three small scale field trials in which the proposed EP was used. 
Aflatoxin in treated peanuts is decreased by 71% to 98% in comparison 
to untreated controls demonstrating displacement of the aflatoxin-
producing strains from the treated peanuts. (BPPD DER, 05/05/2004).

VIII. 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, EPA will continue to use those procedures, with 
appropriate adjustments, until the necessary modifications can be made. 
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) 
of the FFDCA, as was provided in the old sections 408 and 409 of the 
FFDCA. 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 ID number OPP-2004-0164 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 August 
30, 2004.
    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 (1900L), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver

[[Page 39349]]

your request to the Office of the Hearing Clerk in Suite 350, 1099 14th 
St., NW., Washington, DC 20005. 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) 564-
6255.
    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-
0001.
    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 20460-0001.
    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 ADDRESSES. Mail 
your copies, identified by docket ID number OPP-2004-0164, 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-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in ADDRESSES. 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).

IX. Statutory and Executive Order Reviews

    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). Because this rule has been exempted from review under Executive 
Order 12866 due to its lack of significance, this rule is not subject 
to Executive Order 13211, Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 
May 22, 2001). 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) (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 
petition under section 408(d) of the FFDCA, such as the 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. 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 section 408(n)(4) of the FFDCA. 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

[[Page 39350]]

responsibilities between the Federal Government and Indian tribes, as 
specified in Executive Order 13175. Thus, Executive Order 13175 does 
not apply to this rule.

X. Congressional Review Act

    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: June 21, 2004.
James Jones,
Director, 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 added to subpart D to read as follows:


Sec.  180.1254  Aspergillus flavus NRRL 21882 on peanut; exemption from 
requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of Aspergillus flavus NRRL 21882 on peanut and its food/feed 
commodities.
[FR Doc. 04-14609 Filed 6-29-04; 8:45 am]
BILLING CODE 6560-50-S