[Federal Register Volume 69, Number 107 (Thursday, June 3, 2004)]
[Rules and Regulations]
[Pages 31297-31301]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-12558]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2004-0041; FRL-7361-3]


Streptomyces lydicus WYEC 108; Exemption from the Requirement of 
a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of the microbial pesticide Streptomyces 
lydicus WYEC 108 on all agricultural commodities when applied/used in 
accordance with label directions. Natural Industries, Inc. 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 Streptomyces lydicus WYEC 108.

DATES: This regulation is effective June 3, 2004. Objections and 
requests for hearings must be received on or before August 2, 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-2004-0041. 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 Mall2, 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: Alan Reynolds, Biopesticides and 
Pollution Prevention Division (7511C), Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 605-0515; e-mail address: [email protected].

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)
     Animal production (NAICS 112)
     Food manufacturer (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 (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 August 1, 2000 (65 FR 46912) (FRL -6595-
4), 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 0F6163) by Natural Industries, Inc., 6223 Theall Road, 
Houston, TX 77066. This notice included a summary of the petition 
prepared by the petitioner Natural Industries, Inc. There were no 
comments received in response to the notice of filing.
    The petition requested that 40 CFR part 180 be amended by 
establishing a temporary exemption from the requirement of a tolerance 
for residues of the microbial pesticide Streptomyces lydicus WYEC 108.
    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,

[[Page 31298]]

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.
    Streptomyces lydicus WYEC 108 is a common, well-characterized, 
naturally-occurring soil bacterium. It has been researched extensively 
in both the laboratory and under field conditions and has been 
described in scientific literature for over 45 years. The results of 
the acute toxicology and pathogenicity studies required of the 
petitioner under FFDCA section 408(d)(2)(A) in support of the petition 
for an exemption from the requirement of a tolerance for Streptomyces 
lydicus WYEC 108 indicate that the bacterium is non-toxic, non-
irritating, and non-pathogenic.
    Tests performed by Natural Industries, Inc. cited in support of 
this Food Tolerance Exemption Petition are summarized below.
    1. Acute oral toxicity - Rat (OPPTS Harmonized Guideline 870.1100) 
MRID 451117-01.
    Test Material: Actinovate Soluble.
    Test Dose: 5,050 mg/per/kg, CFU not measured.
    Result: No mortality, LD50 > 5,050 mg/per/kg; no 
observable abnormalities on necropsy, and minor clinical signs 
(piloerection in all 3 males at 24 hours, diarrhea in 1 female each at 
1 and 2 hours and soft feces in 1 male at 4 hours) with complete 
symptom clearance by day 2. (J. Gagliardi/J. Kough memorandum to A. 
Reynolds, 1/14/04 (hereafter referred to as BPPD Review - 1/14/04)).
    2 Acute pulmonary toxicity/pathogenicity - Rat (OPPTS Harmonize 
Guideline 885.3150) MRID 451117-02.
    Test Material: Streptomyces lydicus WYEC 108 (TGAI).
    Test Dose: 9.1 x 108 CFU per animal, plus an inactivated 
control.
    Result: No mortality, LD50 > 9.1 x 108 CFU 
per animal; inactivated control produced slight piloerection in all 
animals; Streptomyces lydicus WYEC 108 produced piloerection plus crust 
on eyes, walking on tiptoe, and one female with raspy breathing. 
Necropsy showed no abnormalities and WYEC 108 cleared from all tissues 
by 28 days (BPPD Review - 1/14/04).
    3. Acute injection toxicity/pathogenicity - Rat (OPPTS Harmonize 
Guideline 885.3200) MRID 451117-03.
    Test Material: Streptomyces lydicus WYEC 108 (TGAI).
    Test Dose: 9.33 x 108 CFU per animal, plus an 
inactivated control.
    Result: No mortality, LD50 >9.33 x 108 CFU 
per animal; inactivated control and Streptomyces lydicus WYEC 108 
produced no clinical symptomology with no observable abnormalities on 
necropsy, though one control male had an enlarged/hardened abdomen and 
also one control male had an enlarged and mottled spleen and liver(BPPD 
Review - 1/14/04).
    4. Hypersensitivity incidents (OPPTS Harmonize Guideline. 
885.3400). The registrant reported (April 24, 2000) no incidents to 
date. Nonetheless, the registrant is required to report to the Agency 
any future incidents of hypersensitivity associated with Streptomyces 
lydicus WYEC 108 pursuant to FIFRA section 6(a)(2).
    5. Data Waivers: In addition to the data summarized above, the 
following required studies were waived for Streptomyces lydicus.
    i. Acute oral toxicity/pathogenicity (OPPTS 885.3050). An 
acceptable acute oral toxicity study (870.1100) was submitted by the 
registrant (discussed above). This study showed no mortality or 
abnormalities among the orally- dosed rats (Toxicity Category IV). In 
addition, toxicity/pathogenicity studies were conducted on the most 
likely route of human exposure, pulmonary, and the most sensitive route 
of exposure, intravenous injection, to determine whether or not the 
material is toxic, pathogenic, or infective to mammals. Both of those 
studies were acceptable and demonstrated a lack of toxicity and 
pathogenicity from Streptomyces lydicus WYEC 108 to the test animals. 
Therefore, the data waiver request for acute oral toxicity/
pathogenicity testing was granted (J. Gagliardi/J. Kough memorandum to 
A. Reynolds, 5/21/03 (hereafter referred to as BPPD Review - 5/21/03).
    ii. Acute dermal toxicity/pathogenicity (OPPTS 885.3100). The 
registrant has submitted acceptable acute oral toxicity, acute 
pulmonary toxicity/pathogenicity, acute injection toxicity/
pathogenicity, primary eye irritation, and primary dermal irritation 
studies that demonstrate the lack of toxicity, pathogenicity, 
infectivity, and irritation for the active ingredient, Streptomyces 
lydicus WYEC 108 (see discussions above). As such, the data waiver 
request for acute dermal toxicity/pathogenicity testing was granted (J. 
Gagliardi/J. Kough memorandum to A. Reynolds, 2/11/04).
    iii. Acute inhalation toxicity (OPPTS 870.1300). The registrant 
submitted an acceptable acute pulmonary toxicity/pathogenicity study 
(see discussion above) that demonstrated no toxicity, pathogenicity, or 
infectivity associated with the active ingredient, Streptomyces lydicus 
WYEC 108. The inert ingredients in the end-use product are not expected 
to increase the pathogenicity or toxicity of the TGAI. As such, the 
data waiver request for acute inhalation toxicity testing was granted 
(BPPD Review - 5/21/03).
    iv. Hypersensitivity study (OPPTS 870.2600). The registrant has 
reported that there have been no hypersensitivity incidents during 
production and testing of Streptomyces lydicus WYEC 108 (TGAI or end 
use product). In addition, the submitted toxicity and irritation 
studies (as discussed above) have shown minimal toxicity and/or 
irritation potential for Streptomyces lydicus WYEC 108. The registrant 
is required to also report any adverse incidents to the Agency under 
FIFRA section 6(a)(2). Therefore, the data waiver request for the 
hypersensitivity study was granted (BPPD Review - 5/21/03).
    v. Immune response (OPPTS 885.3800). The submitted acute injection 
toxicity/pathogenicity study (as discussed above) demonstrated that 
Streptomyces lydicus WYEC 108 is cleared by the immune system from the 
bodies of the test animals. Therefore, the data waiver request for 
immune response testing was granted (BPPD Review - 5/21/03).
    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).

[[Page 31299]]

A. Dietary Exposure

    Humans and animals are commonly exposed to Streptomyces lydicus, a 
common and naturally-occurring soil-inhabiting bacterium. No 
toxicological endpoints were identified for Streptomyces lydicus WYEC 
108. The low toxicity and non-pathogenicity of Streptomyces lydicus 
WYEC 108 is demonstrated by the data summarized in Unit III above.
    1. Food. The method of application for Streptomyces lydicus WYEC 
108 is a soil mix/drench to potted plants and turf grass or as a foliar 
application to greenhouse crops. As such, there may be plant residues 
of Streptomyces lydicus WYEC 108 and dietary exposure on agricultural 
commodities. However, negligible to no risk is expected for the general 
population, including infants and children, because Streptomyces 
lydicus WYEC 108 demonstrated no pathogenicity or oral toxicity at the 
maximum doses tested (as noted in Unit III above).
    2. Drinking water exposure. Streptomyces lydicus WYEC 108 is found 
naturally in soil, but does not thrive in aquatic environments. There 
are also no aquatic use sites for the pesticide, so exposure in 
drinking water is not expected. In addition, there is no evidence of 
adverse effects from oral, dermal, or inhalation exposure to this 
microbial agent (see Unit III above). Accordingly, the use of 
Streptomyces lydicus WYEC 108 on terrestrial plants is not expected to 
negatively impact the quality of drinking water.

B. Other Non-Occupational Exposure

    Based on the proposed agricultural and horticultural use patterns, 
the potential for non-dietary exposure to Streptomyces lydicus WYEC 108 
residues for general population, including infants and children, is 
unlikely. In addition, adults are required to wear personal protective 
equipment during application to mitigate any exposure. Accordingly, the 
Agency believes that the potential aggregate non-occupational exposure, 
derived from dermal and inhalation exposure through the application of 
Streptomyces lydicus WYEC 108, should fall well below the currently 
tested microbial safety standards.
    The potential for dermal or inhalation exposure to Streptomyces 
lydicus WYEC 108 pesticide residues for the general population, 
including infants and children, is unlikely because the potential use 
sites are agricultural and horticultural. However, since Streptomyces 
lydicus is a common, naturally-occurring soil bacterium, there is a 
great likelihood of prior exposure for most, if not all individuals. 
Accordingly, the increase in exposure due to this proposed microbial 
pesticide would be negligible. Furthermore, as demonstrated in Unit III 
above, the organism is essentially non-irritating (Toxicity Category 
IV) and the acute pulmonary toxicity/pathogenicity testing performed on 
Streptomyces lydicus WYEC 108 demonstrated no pathogenicity or 
toxicity. As such, the risks anticipated for these routes of exposure 
are considered minimal.

V. Cumulative Effects

    Section 408(b)(2)(D)(v) of FFDCA requires the Agency, when 
considering whether to establish, modify, or revoke a tolerance, to 
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 
ofStreptomyces lydicus WYEC 108 and other substances in relation to a 
common mechanism of toxicity. As demonstrated above, Streptomyces 
lydicus WYEC 108 is non-toxic and non-pathogenic to mammals. Because no 
mechanism of pathogenicity or toxicity in mammals has been identified 
for this organism (see Unit III above), no cumulative effects from the 
residues of this product with other related microbial pesticides are 
anticipated.

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

    There is a reasonable certainty that no harm to the U.S. 
population, including infants and children, will result from aggregate 
exposure to residues of Streptomyces lydicus WYEC 108 due to its use as 
a microbial pest control agent. This includes all anticipated dietary 
exposures and all other exposures for which there is reliable 
information. As discussed in Unit III above, Streptomyces lydicus WYEC 
108 is not pathogenic or infective and is non-toxic to mammals. 
Accordingly, exempting Streptomyces lydicus WYEC 108 from the 
requirement of a tolerance should be considered safe and pose no 
significant risks.
    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 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 often are 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. 
Because Streptomyces lydicus WYEC 108 is a common, naturally-occurring 
bacterium, residues of this microbial pesticide in or on agricultural 
commodities are not expected to significantly increase exposure to the 
U.S. population, including infants and children. In addition, actual 
exposures to adults and children through diet are expected to be 
several orders of magnitude less than the doses used in the toxicity 
and pathogenicity tests referenced in Unit III above. Thus, 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.

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 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, Streptomyces lydicus WYEC 108 may be subjected to additional

[[Page 31300]]

screening and/or testing to better characterize effects related to 
endocrine disruption.
    The submitted toxicity/pathogenicity studies indicated that 
following several routes of exposure, the immune systems of the tested 
animals were not compromised and that they were able to clear the 
active ingredient (see Unit III above). Based on the available data, 
there is no current evidence that Streptomyces lydicus WYEC 108 acts as 
a hormone or endocrine disruptor, or that it produces toxins or 
secondary metabolites that would cause mammalian toxicity, 
pathogenicity, or irritation. Thus, there is no impact via endocrine-
related effects on the Agency's safety finding set forth in this Final 
Rule for Streptomyces lydicus WYEC 108.

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, including Streptomyces lydicus WYEC 108's lack of mammalian 
toxicity. Streptomyces lydicus WYEC 108 is a common and naturally-
occurring soil-inhabiting bacterium. 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. 
For these reasons, the Agency has concluded that an analytical method 
is not required for enforcement purposes for Streptomyces lydicus WYEC 
108.

C. Codex Maximum Residue Level

    There is no Codex Alimentarium Commission Maximum Residue Level for 
Streptomyces lydicus WYEC 108.

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-2004-0041 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 2, 
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 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-2004-0041, 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).

[[Page 31301]]

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 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: May 24, 2004.
Jim Jones,
Director, Office of Pesticide Programs.

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Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

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2. Section 180.1253 is added to subpart D to read as follows:


Sec.  180.1253  Streptomyces lydicus WYEC 108; Exemption from the 
Requirement of a Tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of the microbial pesticide Streptomyces lydicus WYEC 108 when 
used in or on all agricultural commodities when applied/used in 
accordance with label directions.
[FR Doc. 04-12558 Filed 6-2-04; 8:45 am]
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