Paecilomyces lilacinus strain 251; Exemption from the Requirement of a Tolerance, 19278-19283 [05-7226]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 70, Number 70 (Wednesday, April 13, 2005)]
[Rules and Regulations]
[Pages 19278-19283]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-7226]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2004-0397; FRL-7708-4]


Paecilomyces lilacinus strain 251; 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 fungus Paecilomyces lilacinus (P. 
lilacinus) strain 251 in or on food commodities when applied or used in 
accordance with label directions. Prophyta Biologischer Pflanzenschutz 
GmbH, Germany 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. Notification that EPA had received the petition was 
published on November 7, 2003 (68 FR 63088-92) (FRL-7331-7). This 
regulation eliminates the need to establish a maximum permissible level 
for residues of P. lilacinus strain 251.

DATES: This regulation is effective April 13, 2005. Objections and 
requests for hearings must be received on or before June 13, 2005.

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-2004-0397. All documents in the docket are listed in the 
EDOCKET index at https://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, 1801 S. Bell St., 
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: Barbara Mandula, Biopesticides and 
Pollution Prevention Division (7511C), Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-7378; e-mail address: mandula.barbara@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop Production/ Agriculture (NAICS 111)

[[Page 19279]]

     Animal production (NAICS 112)
     Food manufacturing (NAICS 311),
     Pesticide manufacturing (NAICS 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 (https://www.epa.gov/edocket/), you may 
access this Federal Register document electronically through the EPA 
Internet under the ``Federal Register'' listings at https://www.epa.gov/
fedrgstr/. A frequently updated electronic version of 40 CFR part 180 
is available at E-CFR Beta Site Two at https://www.gpoaccess.gov/ecfr/.

II. Background and Statutory Findings

    In the Federal Register of November 7, 2003 (68 FR 63088-92) (FRL-
7331-7), 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 3F6737) by (Prophyta Biologischer Pflanzenschutz 
GmbH, Germany: US Agent: WF Stoneman Co., LLC, PO Box 465, McFarland, 
WI 53558-0465. This notice included a summary of the petition prepared 
by the petitioner, Prophyta Biologischer Pflanzenschutz GmbH, Germany. 
The petition requested that 40 CFR part 180 be amended by establishing 
a permanent exemption from the requirement of a tolerance for residues 
of P. lilacinus strain 251 in or on food commodities when applied or 
used in accordance with label directions as a nematicide for the 
control of plant parasitic nematodes. There were no comments received 
in response to the notice of filing.
    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 non-occupational 
exposures that occur as a result of pesticide use.

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.
     P. lilacinus strain 251 is a naturally occurring fungus commonly 
found in soil. Unlike many other P. lilacinus strains, P. lilacinus 
strain 251 does not produce mycotoxins or paecilotoxins. In addition, 
the results of acute toxicology and pathogenicity studies submitted by 
the petitioner in support of its petition for an exemption from the 
requirement of a tolerance for P. lilacinus strain 251 indicate 
negligible to no mammalian toxicity. Moreover, no pathogenicity was 
observed in any of the tests conducted with P. lilacinus strain 251. 
Accordingly, the toxicology and pathogenicity data generated by 
Prophyta Biologischer Pflanzenschutz GmbH, Germany support an exemption 
from the requirements of a tolerance. The data relevant to and in 
support of this tolerance exemption are presented in more detail below.
    1. Acute toxicity--i. acute oral toxicity-rat (OPPTS Guideline 
870.1100; MRID 462832-01). The test material (2,000 mg/kg body weight) 
was given to five male and five female rats by gavage in a 10% w/w 
suspension in water. All animals were necropsied and organ weights were 
recorded after 14 days. No clinical signs of toxicity were seen. The 
oral LD50 for males, females, and combined was greater than 
2,000 mg/kg. Classification: acceptable; Toxicity Category III.
    ii. Acute dermal toxicity-rat (OPPTS Guideline 870.1200; MRID 
462832-02). The test material (2,000 mg/kg body weight) was applied to 
the clipped dorsal trunk of five male and five female rats on an area 
36 cm2 for 24 hours. No abnormal clinical signs were seen 
during 14 days of observation. The acute lethal dose (LD50) 
is greater than 2,000 mg/kg. Classification: acceptable; Toxicity 
Category III.
    iii. Acute pulmonary toxicity/pathogenicity-rat (OPPTS Guideline 
885.3150; MRID 459418-04). Test material was administered by a single 
intratracheal dose of 0.05 milliliters (mL) containing 2.5 x 
108 conidia, to 35 male and 35 female rats. No clinical 
signs were seen during 15 days of observation. P. lilacinus strain 251 
was detected in lungs and lung lymph nodes with clearance after 15 
days, and in tracheal lymph nodes with clearance after 4 days. Based on 
this study, the test organism was not toxic, infective, or pathogenic 
to rats at the applied dose. Classification: acceptable; Toxicity 
Category III.
    iv. Primary eye irritation-rabbit (OPPTS Guideline 870.2400; MRID 
460042-07). Test material (100 mg/eye/animal) was applied in the 
conjunctival sac of one eye, and 0.1 mL distilled water as a control in 
the other eye of three male rabbits. After 72 hours, no corneal 
opacity, iritis, or other signs of irritation were seen. 
Classification: acceptable; Toxicity category IV.
    v. Hypersensitivity study-guinea pig (OPPTS Guideline 870.2600; 
MRID 459418-07). The animals were induced and challenged according to 
the method of Buehler. Twenty animals were test animals, and 25 animals 
served as positive and negative controls. Once per week for 3 weeks, 
approximately 0.5 grams(g) of test material was applied to the shaved 
skin of test guinea pigs for 6 hours. When challenged with 0.25 g

[[Page 19280]]

test material 12 days after the last induction, no signs of 
sensitization appeared. The test material is not a dermal sensitizer. 
Classification: acceptable.
    vi. Reporting hypersensitivity incidents (OPPTS Guideline 
885.3400). The registrant has reported no incidents to date. 
Nonetheless, pursuant to FIFRA section 6(a)(2), the registrant is 
required to report to the Agency any future incidents of 
hypersensitivity associated with P. lilacinus strain 251.
    vii. Primary dermal irritation-rabbit (OPPTS Guideline 870.2500; 
MRID 459418-06). Three female rabbits were each dosed with 0.5 g test 
material applied on gauze to clipped skin for 4 hours. During the next 
72 hours, no clinical signs or irritation were seen. P. lilacinus 
strain 251 was non-irritating at the test dose. Classification: 
acceptable; Toxicity Category IV.
    viii. Acute intraperitoneal toxicity/pathogenicity-rat (OPPTS 
Guideline 885.3200; MRID 460042-01). The testing laboratory reported 
that the test material was administered to five male and five female 
rats by a single intraperitoneal dose of 2,000 mg/kg body weight. The 
laboratory did not confirm the titre of the test substance. No clinical 
signs of toxicity or pathogenicity were observed in any of the treated 
or control rats during the 14-day observation period. All rats survived 
for 14 days. Both control and test animals showed evidence of 
mycoplasmosis infection on necropsy, but no evidence of abnormalities 
attributable to the test substance. No test organisms were detected in 
any of the test animals or in the two control animals examined when the 
following organs were analyzed: liver, kidney, spleen, lungs, brain, 
urinary bladder, lymphatic ganglia, or thymus. The digestive tract of 
one test male and one test female had 270 and 290 cfu/organ 
respectively, which is attributed to environmental contamination rather 
than to infectivity. Because the testing laboratory did not analyze the 
test material for viable conidia before dosing, there is some 
uncertainty about the viability and dose of the test material. However, 
3.89 x 109 cfu/g was found when the registrant analyzed a 
portion of the test production batch in November 2001, when the lab did 
its testing. If the test laboratory sample was appropriately shipped 
and stored, the test sample should have contained a concentration of 
3.89 x 109 cfu/g sample, an adequate concentration for 
testing. Also, while the organ analyses suggest a low level of 
laboratory environmental contamination with the test organism, the 
detection of this contamination indicates that the laboratory was 
capable of detecting the microbe in the various organs if it had been 
present. While the study is flawed because the test laboratory did not 
analyze the viability of the test material before dosing, EPA believes 
that a sufficient concentration of viable microbes was likely used in 
testing. EPA classifies the study as supplemental because it provides 
supporting evidence that P. lilacinus strain 251 is not toxic or 
pathogenic to mammals. Classification: supplementary.
    ix. Immune response (OPPTS Guideline 880.3800). The registrant 
submitted a waiver request for the immune response study. The waiver 
was granted, based on results of various rodent studies that showed no 
evidence of adverse effects to the immune system (MRID 462832-01; 
459418-04). Animal behavior and weight gain remained normal, and there 
was no excess morbidity or mortality in the studies. No organ 
abnormalities attributed to the test material were seen on necropsy. In 
a pulmonary pathogenicity study, the fungal titre in various organs 
decreased during the first 8 days after dosing, and clearance was 
complete by 14 days. This clearance provides evidence that the immune 
system was functioning, although a concomitant explanation is that the 
conidia became non-viable over time because they do not survive more 
than a few days at temperatures above 36 [deg]C. Taken together, these 
data indicate that P. lilacinus strain 251 does not interfere with 
immune system function.
    2. Dose response assessment. No toxicological responses have been 
identified. Therefore, a dose response assessment could not be 
performed.
    3. Subchronic and chronic toxicity. Based on the data generated in 
accordance with the Tier I toxicology data requirements set forth in 40 
CFR 158.740(c), the Tier II and Tier III toxicology data requirements 
also set forth therein were not triggered and, therefore, not required 
in connection with this action. In addition, because the Tier II and 
Tier III toxicology 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

    Humans may be exposed dermally and orally to the common soil 
microbe P. lilacinus strain 251 when they get soil on their hands or 
clothing, or handle pets that have played in soil. Importantly, 
however, no toxicological endpoints were identified for P. lilacinus 
strain 251 and there is no evidence of adverse effects from oral, 
dermal, or pulmonary exposure to this microbial agent. The low toxicity 
and non-pathogenicity/infectivity of P. lilacinus strain 251 are 
demonstrated by the data summarized in Unit III of this preamble.
    1. Food. While the proposed use pattern may result in dietary 
exposure with possible residues in or on certain agricultural 
commodities, negligible, to no risk, is expected for the general 
population, including infants and children, or animals because P. 
lilacinus strain 251 demonstrated no pathogenicity or oral toxicity at 
the maximum dose tested, as noted above in Unit III.
    2. Drinking water exposure. The potential for transfer of P. 
lilacinus strain 251 to surface or ground water during run-off 
associated with intended use applications is considered minimal, due to 
its percolation through and resulting capture in soil, and its 
attachment to plant root nematodes. Accordingly, the use of this 
microbial pest control agent on terrestrial plants is not anticipated 
to lower the quality of drinking water. Even if low levels of the 
microbe were present in drinking water, no risk to the general public 
would be expected because P. lilacinus strain 251 demonstrated no oral 
pathogenicity or toxicity at the maximum dose tested.

B. Other Non-Occupational Exposures

    Based on the proposed use patterns, in which P. lilacinus strain 
251 is applied directly to soil of agricultural and ornamental crops, 
the potential for non-dietary, non-occupational exposures to P. 
lilacinus strain 251 pesticide residues by the general population, 
including infants and children, is low. Moreover, even in the unlikely 
event of non-dietary, non-occupational exposures to P. lilacinus strain 
251 pesticide residues, no harm is expected because no toxicity or 
pathogenicity was found in mammalian studies that included high levels 
of oral, pulmonary, and dermal exposure.
    1. Dermal exposure. The potential for dermal exposure to P. 
lilacinus strain 251 pesticide residues for the general population, 
including infants and

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children, is low because there are no residential uses for this 
pesticide, which will be applied directly to soils used for growing 
agricultural and ornamental crops. In addition, because P. lilacinus 
strain 251 is a naturally-occurring bacterium in soil, which means 
there is a great likelihood of prior exposure for most, if not all, 
individuals, any actual increase in dermal exposure due to the 
pesticidal use of P. lilacinus strain 251 would be negligible. 
Furthermore, and as demonstrated in Unit III of this preamble, the 
organism shows low to no dermal toxicity, the acute lethal dose 
(LD50) is greater than 2000 mg/kg (Toxicity Category III), 
and P. lilacinus strain 251 is essentially non-irritating (Toxicity 
Category IV). Accordingly, the risks anticipated for this route of 
exposure, should it occur, are minimal to non-existent.
    2. Inhalation exposure. Inhalation exposure to P. lilacinus strain 
251 pesticide residues for the general population, including infants 
and children, is unlikely because there are no residential use sites 
and the pesticide is applied directly to soil as a liquid preparation. 
In addition, because P. lilacinus strain 251 is a naturally-occurring 
bacterium in soil, which means there is a great likelihood of prior 
exposure for most, if not all, individuals, any actual increase in 
inhalation exposure due to the pesticidal use of P. lilacinus strain 
251 would be negligible. Furthermore, and as demonstrated in Unit III 
of this preamble, the acute pulmonary toxicity/pathogenicity testing 
performed on the active ingredient did not demonstrate pathogenicity or 
toxicity of P. lilacinus strain 251. (See Unit III of this preamble.) 
Accordingly, the risks anticipated for this route of exposure, should 
it occur, are considered minimal.

V. Cumulative Effects

    Section 408(b)(2)(D)(v) of FFDCA requires that, when considering 
whether to establish, modify, or revoke a tolerance, 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.'' These considerations include the 
possible cumulative effects of such residues on infants and children. 
The Agency has considered the potential for cumulative effects of P. 
lilacinus strain 251 and other substances in relation to a common 
mechanism of toxicity. P. lilacinus strain 251 is practically non-toxic 
to mammals. Because no mechanism of pathogenicity or toxicity in 
mammals has been identified for this organism (see Unit III of this 
preamble.), no cumulative effects to humans, including infants and 
children, from the interaction of residues of this product with other 
related microbial pesticides are anticipated when this product is used 
as directed on the label and in accordance with good agricultural 
practices.

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

    There is a reasonable certainty that no harm will result to the 
U.S. population, including infants and children, from aggregate 
exposure to residues of P. lilacinus strain 251 due to its use as a 
nematicide. This includes all anticipated dietary exposures and all 
other exposures for which there is reliable information. As discussed 
previously, P. lilacinus strain 251 is not pathogenic or infective and 
is practically non-toxic to mammals. (See Unit III of this preamble.) 
Accordingly, exempting P. lilacinus strain 251 from the requirement of 
a tolerance should be considered safe and pose no significant risk.
    FFDCA section 408(b)(2)(C) 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 prenatal and postnatal 
toxicity and the completeness of the database 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) are 
incorporated into EPA risk assessments either by using uncertainty 
(safety) factors in calculating a dose level that poses no appreciable 
risk to humans, or using a margin of exposure analysis.
    Human exposure is expected to be negligible if users follow label 
directions for this pesticide agent. Moreover, considering the 
ubiquitous nature of P. lilacinus strain 251 in the soil, residues of 
this microbial pesticide in or on agricultural commodities are not 
expected to significantly increase the exposure of the U.S. population, 
including infants and children, to P. lilacinus strain 251. 
Furthermore, high doses of P. lilacinus strain 251, as demonstrated in 
Unit III of this preamble, show virtually no mammalian toxicity and no 
pathogenicity when tested by several routes of exposure, including oral 
and dermal. Hence, EPA concludes that the toxicity and exposure data 
are sufficiently complete to adequately address the potential for 
additional sensitivity of infants and children to residues of P. 
lilacinus strain 251 and that there is a reasonable certainty that no 
harm will result to infants and children from aggregate exposure to P. 
lilacinus strain 251 residues. Thus, the Agency has determined that the 
additional margin of safety is not necessary to protect infants and 
children.

VII. Other Considerations

A. Endocrine Disruptors and Immune System

    1. Endocrine disrupters. 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 is no scientific 
basis for including, as part of the screening program, the androgen and 
thyroid hormone 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 wildlife evaluations. As the science develops and 
resources allow, screening of additional hormone systems may be added 
to the Endocrine Disruptor Screening Program (EDSP). When the 
appropriate screening and/or testing protocols being considered under 
the Agency's EDSP have been developed, P. lilacinus strain 251 may be 
subjected to additional screening and/or testing to better characterize 
effects related to endocrine disruption. Based on the weight of the 
evidence of available data, no endocrine system-related effects have 
been identified for P. lilacinus strain 251. As a result, the Agency 
has determined that there is no impact via endocrine-related effects on 
the Agency's safety finding set forth in this Final Rule for P. 
lilacinus strain 251.
    2. Immune system. To date, the Agency has no information to suggest 
that P. lilacinus strain 251 has an adverse effect on the immune 
system, the physiologic system that protects humans and other organisms 
from infections and other diseases. As is expected from a non-
pathogenic microorganism that is practically non-

[[Page 19282]]

toxic to mammals, the submitted toxicity/pathogenicity studies in 
rodents indicate that following various routes of exposure, the immune 
system is still intact. For example, lack of morbidity, mortality, 
weight loss or behavior changes in the test animals provides evidence 
that the immune system continues to function after dosing.

B. Analytical Method(s)

    The Agency proposes to establish an exemption from the requirement 
of a tolerance without any numerical limitation for the reasons stated 
above (see Unit III of this preamble), including a lack of mammalian 
toxicity for P. lilacinus strain 251. For the same reasons, the Agency 
has concluded that an analytical method is not required for enforcement 
purpose for P. lilacinus strain 251.

C. Codex Maximum Residue Level

    There is no Codex Alimentarius Commission Maximum Residue Level 
(MRL) for P. lilacinus strain 251.

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-2004-0397 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 June 13, 
2005.
    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 (1900C), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Rm.104, Crystal Mall 2, 1801 
Bell St. S, Arlington, VA. 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 (703) 603-0061.
    2. 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-2004-0397, 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: opp-docket@epa.gov. 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 requirement of a 
tolerance 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,

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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 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: March 29, 2005.
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 180.1257 is added to subpart D to read as follows:


Sec.  180.1257  Paecilomyces lilacinus strain 251; exemption from the 
requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of the microbial pesticide Paecilomyces lilacinus strain 251 
when used in or on all agricultural commodities when applied/used in 
accordance with label directions.

[FR Doc. 05-7226 Filed 4-12-05; 8:45 am]
BILLING CODE 6560-50-S