Document ID: EPA-HQ-OPP-2009-0407-0004
Agency: epa
Document Type: Rule
Title: Exemptions from the Requirement of a Tolerance: Trichoderma Hamatum Isolate 382
Posted Date: 2010-07-23T04:00Z

[Federal Register Volume 75, Number 141 (Friday, July 23, 2010)]
[Rules and Regulations]
[Pages 43072-43076]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-18076]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

EPA-HQ-OPP-2009-0407; FRL-8835-6

Trichoderma Hamatum Isolate 382; 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, Trichoderma 
hamatum isolate 382, in or on all food commodities when applied as a 
fungicide and used in accordance with good agricultural practices. 
Interregional Research Project Number 4 (IR-4) of Rutgers University 
(on behalf of Sellew and Associates, LLC) submitted a petition to EPA 
under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an 
exemption from the requirement of a tolerance. This regulation 
eliminates the need to establish a maximum permissible level for 
residues of Trichoderma hamatum isolate 382 under the FFDCA.

DATES: This regulation is effective July 23, 2010. Objections and 
requests for hearings must be received on or before September 21, 2010, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2009-0407. All documents in the 
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (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 in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the Office of Pesticide Programs (OPP) Regulatory Public 
Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal 
Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays. The Docket 
Facility telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Ann Sibold, Biopesticides and 
Pollution Prevention Division (7511P), Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-6502; e-mail address: sibold.ann@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 (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. 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 Get Electronic Access to Other Related Information?

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Printing Office's e-CFR site at http://www.gpoaccess.gov/ecfr. To access the Harmonized Test Guidelines 
referenced in this document electronically, please go to http://www.epa.gov/ocspp and select ``Test Methods and Guidelines.''

C. How Can I File an Objection or Hearing Request?

    Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2009-0407 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
September 21, 2010. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket. Information not marked confidential pursuant to 40 CFR part 2 
may be disclosed publicly by EPA without prior notice. Submit a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2009-0407 by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: OPP Regulatory Public Docket (7502P), Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Background and Statutory Findings

     In the Federal Register of July 22, 2009 (74 FR 36200) (FRL-8425-
8), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance 
petition (PP 7E7188) by IR-4, Rutgers University, 500 College Road, 
East, Suite 201W, Princeton, NJ 08540 (on behalf of Sellew and 
Associates, LLC, 84 Shadybrook Lane, Carlisle, MA 01741). The petition 
requested that 40 CFR part 180 be amended by establishing an exemption 
from the requirement of a tolerance for residues of Trichoderma hamatum

[[Page 43073]]

isolate 382. This notice referenced a summary of the petition prepared 
by the petitioner, IR-4 (on behalf of Sellew and Associates, LLC), 
which is available in the docket, http://www.regulations.gov. A comment 
was received on the notice of filing. EPA's response to this comment is 
discussed in Unit VII.C.
    Section 408(c)(2)(A)(i) of 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 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) of FFDCA, 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) of FFDCA, 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 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 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.

A. Overview of Trichoderma Hamatum Isolate 382.

    Trichoderma hamatum isolate 382 is a naturally occurring fungus 
that is found widely in soils, potting media, corn grits, and flour, as 
well as on root surfaces of various plants, decaying bark, fruits, and 
vegetables. Indeed, Trichoderma hamatum populations have been measured 
at levels between 1 x 104 and 1 x 108 colony-
forming units (cfu) per gram dry weight of container media alone. As a 
pesticidal active ingredient, Trichoderma hamatum isolate 382 will be 
mixed with or applied to soilless potting media or compost mainly to 
induce systemic resistance to diseases of roots and aboveground plant 
parts. It may also suppress the activity of certain soilborne plant 
pathogens (including Pythium species, Phytophthora species, Fusarium 
species, Rhizoctonia solani, Sclerotium rolfsii, and Thielaviopsis 
basicola) and protect the foliage of some plant species from powdery 
mildew, Botrytis blight, Phytophthora blights, and dieback diseases 
(e.g., Botryosphaeria dieback) through competition for nutrients and 
space. No relationships are known between the Trichoderma genus and any 
pathogen of humans, animals, or plants. Most notably, Trichoderma 
hamatum isolate 382 is not considered a dermatophyte fungus in that it 
is not classified into any of the three genera (Microsporum, 
Epidermophyton, and Trichophyton) known to cause skin disease in 
animals and humans.
    In conjunction with Experimental Use Permit 69006-EUP-1, which was 
effective from January 1, 1996 until January 1, 1998, a temporary 
exemption from the requirement of a tolerance was established 
previously for Trichoderma hamatum isolate 382 for use on selected 
ornamentals and vegetable bedding plants in or on the raw agricultural 
commodities broccoli, cabbage, cauliflower, cucumber, eggplant, 
lettuce, cantaloupe, pepper, tomato, and watermelon (61 FR 28580, June 
5, 1996, FRL-5371-2). This temporary exemption expired on March 1, 
1998. Although there are no currently existing tolerances or tolerance 
exemptions for Trichoderma hamatum species, there are permanent 
tolerance exemptions established for all food commodities for two 
strains of a closely related Trichoderma species: Trichoderma harzianum 
KRL-AG2 (ATCC 20847) strain T-22 under 40 CFR 180.1102 (64 FR 
16856, April 7, 1999 FRL-6070-3) and Trichoderma harzianum strain T-39 
under 40 CFR 180.1201 (65 FR 38753, June 22, 2000, FRL-6383-7).
    The petitioner submitted Tier I mammalian toxicology data for the 
active ingredient, Trichoderma hamatum isolate 382. EPA has reviewed 
and found these data acceptable to support the establishment of a 
permanent exemption from the requirement of a tolerance for residues of 
Trichoderma hamatum isolate 382. These studies indicate that the active 
ingredient is not toxic, infective, and/or pathogenic to rats when 
administered by the oral, pulmonary, or injection routes of exposure 
and is only slightly irritating to the skin. Furthermore, even with 
extensive experimental uses in the mid- to late-1990s and subsequent 
compilation of data to support potential pesticide products, no 
Trichoderma hamatum isolate 382-related hypersensitivity incidents have 
been reported to EPA. The overall conclusions from these data are 
described in Unit III.B., while more in-depth synopses of the study 
results can be found in the risk assessments and Biopesticides 
Registration Action Document provided as references in Unit III.C.

B. Microbial Pesticide Toxicology Data Requirements

    1. Acute oral toxicity and pathogenicity - rat (Harmonized Test 
Guideline 885.3050; Master Record Identification Number (MRID No.) 
455836-03). An acceptable acute oral and pathogenicity study 
demonstrated that Trichoderma hamatum isolate 382 was not toxic, 
infective, and/or pathogenic to rats when dosed at up to 3.9 x 
108 cfu/animal (U.S. EPA 2009, 2010b, 2010c).
    2. Acute pulmonary toxicity and pathogenicity - rat (Harmonized 
Test Guideline 885.3150; MRID Nos. 460106-02 and 469997-01). An 
acceptable acute pulmonary toxicity and pathogenicity study 
demonstrated that Trichoderma hamatum isolate 382 was not toxic, 
infective, and/or pathogenic to rats when dosed intratracheally at 1.3 
x 107 cfu/animal (U.S. EPA 2009, 2010b, 2010c).
    3. Acute injection toxicity and pathogenicity - rat (Harmonized 
Test Guideline 885.3200; MRID No. 475989-08). An acceptable acute 
injection toxicity and pathogenicity study demonstrated that 
Trichoderma hamatum isolate 382 was not toxic, infective, and/or 
pathogenic in rats when dosed intraperitoneally at 4.0 x 107 
cfu/animal (U.S. EPA 2009, 2010b, 2010c).
    4. Hypersensitivity incidents (Harmonized Test Guideline 885.3400). 
No hypersensitivity incidents involving Trichoderma hamatum isolate 382 
and

[[Page 43074]]

occurring during fermentation, processing, formulation, or research 
have been reported to the Agency. Any future hypersensitivity incidents 
must be reported per 40 CFR 158.2140 (U.S. EPA 2010c).
    5. Acute oral toxicity (Harmonized Test Guideline 870.1100; MRID 
No. 475989-04), acute dermal toxicity (Harmonized Test Guideline 
870.1200; MRID No. 475989-04), and acute inhalation toxicity 
(Harmonized Test Guideline 870.1300; MRID No. 475989-04). The Agency 
waived these acute toxicity data requirements based on Trichoderma 
hamatum isolate 382's ubiquitous presence in the environment (see Unit 
III.A.) and the absence of incidents of hypersensitivity, allergies, or 
other adverse effects, despite varying uses of Trichoderma hamatum 
isolate 382 since 1996 (e.g., research activities performed in 
accordance with the terms of an experimental use permit) (U.S. EPA 
2009, 2010c).
    6. Primary dermal irritation - rabbit (Harmonized Test Guideline 
870.2500; MRID 475989-05). An acceptable primary dermal irritation 
study demonstrated that Trichoderma hamatum isolate 382 was slightly 
irritating to the skin of rabbits. The study resulted in a 
classification of Toxicity Category IV for this strain of Trichoderma 
hamatum (U.S. EPA 2009, 2010a, 2010c).

C. References

    1. U.S. EPA. 2009. Review of Product Chemistry, Manufacturing 
Process, and Acute Toxicity Studies of the End Use Product (EP) 
Floraguard (EPA Reg. No. 74205-G) Containing the Active Ingredient (AI) 
Trichoderma hamatum isolate 382 (0.9%). Memorandum from I. Barsoum, 
Ph.D. and J. Kough, Ph.D. to A. Sibold dated December 14, 2009 
(available as ``Supporting & Related Materials'' within Docket Number 
EPA-HQ-OPP-2010-0489 at http://www.regulations.gov).
    2. U.S. EPA. 2010a. Review of the Registrant's Response to the 
Deficiencies Found by the Agency in Its Review of Product Chemistry, 
Manufacturing Process, and Acute Toxicity Studies of the Product 
Trichoderma hamatum isolate 382 (EPA Reg. No. 74205-G). Memorandum from 
I. Barsoum, Ph.D. and J. Kough, Ph.D. to A. Sibold dated April 27, 2010 
(available as ``Supporting & Related Materials'' within Docket Number 
EPA-HQ-OPP-2010-0489 at http://www.regulations.gov).
    3. U.S. EPA. 2010b. Review of Information to Support a Food 
Tolerance Determination for Trichoderma hamatum isolate 382 
(ATCC 20765), the Active Ingredient in Floraguard Related to 
Tolerance Petition (7E7188). Memorandum from J. Kough, Ph.D. to A. 
Sibold dated May 18, 2010 (available as ``Supporting & Related 
Materials'' within Docket Number EPA-HQ-OPP-2010-0489 at http://www.regulations.gov).
    4. U.S. EPA. 2010c. Trichoderma hamatum isolate 382 Biopesticides 
Registration Action Document dated June 1, 2010 (available as 
``Supporting & Related Materials'' within Docket Number EPA-HQ-OPP-
2010-0489 at http://www.regulations.gov).

IV. Aggregate Exposures

    In examining aggregate exposure, section 408 of 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

    Dietary exposure to the microbial pesticide may occur (more likely 
through food than drinking water), but the lack of acute oral toxicity, 
infectivity, and/or pathogenicity, based on a toxicology test on rats 
presented in Unit III.B., is just one of several factors supporting the 
establishment of a permanent exemption from the requirement of a 
tolerance for residues of Trichoderma hamatum isolate 382.
    1. Food. Dietary exposure to the microbial active ingredient is 
expected to be minimal. Trichoderma hamatum isolate 382 is only 
intended for directed application to or incorporation into soilless 
potting media or compost. These application methods are not conducive 
to residue accumulation in crops. Moreover, Trichoderma species live in 
soils and are unlikely to persist on plants. Any spores that end up on 
plants due to application as a pesticide would decrease over time as a 
result of weathering, desiccation, and ultraviolet radiation, which can 
kill even quiescent forms of the fungus. In the remote likelihood that 
the applied fungus grew on the edible portions of treated crops, the 
results of the toxicology testing demonstrated that no toxicity, 
infectivity, and/or pathogenicity in treated animals occurred, even 
when dosed with high levels of Trichoderma hamatum isolate 382 by the 
oral route of exposure (see additional discussion in Unit III.B.).
    2. Drinking water exposure. Drinking water exposure is expected to 
be negligible because the microbial fungicide will not be applied to 
water. Further, Trichoderma hamatum isolate 382 is a soil microorganism 
and would not proliferate in aquatic environments. Moreover, the Agency 
believes that Trichoderma species within the soil will not likely 
percolate into water due to the large size of the fungal spores and the 
fact that they adhere readily to soil particles. Even in the unlikely 
event that dietary exposure occurs through drinking water, the results 
of the oral toxicology testing, as described in Unit III.B., 
demonstrated that no toxicity, infectivity, and/or pathogenicity in 
treated animals occurred.

B. Other Non-Occupational Exposure

    Trichoderma hamatum isolate 382 is a naturally occurring 
microorganism and is ubiquitous in the environment. As a pesticidal 
active ingredient, Trichoderma hamatum isolate 382 will be applied to 
or incorporated into soilless potting media or compost predominantly in 
greenhouses. Although some applications may take place in residential 
areas, there is no evidence of any concern for inhalation or dermal 
toxicity at exposure levels several orders of magnitude higher than 
would be expected to be encountered by a typical residential end user 
(see Unit III.B.). Additionally, as anticipated given that there are no 
recognized relationships between the Trichoderma genus and any pathogen 
of humans and animals, there have been no reports of adverse effects to 
humans from inhalation or dermal exposure to this widespread fungus.

V. Cumulative Effects from Substances with a Common Mechanism of 
Toxicity

    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.''
    EPA has not found Trichoderma hamatum isolate 382 to share a common 
mechanism of toxicity with any other substances, and Trichoderma 
hamatum isolate 382 does not appear to produce a toxic metabolite as 
its mode against the target pests. For the purposes of this tolerance 
exemption action, therefore, EPA has assumed that Trichoderma hamatum 
isolate 382 does not have a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate

[[Page 43075]]

the cumulative effects of such chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative.

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

    FFDCA section 408(b)(2)(C) provides that EPA shall assess the 
available information about consumption patterns among infants and 
children, special susceptibility of infants and children to pesticide 
chemical residues, and the cumulative effects on infants and children 
of the residues and other substances with a common mechanism of 
toxicity. In addition, FFDCA section 408(b)(2)(C) provides that EPA 
shall apply an additional tenfold margin of safety for infants and 
children in the case of threshold effects to account for prenatal and 
postnatal toxicity and the completeness of the database unless EPA 
determines that a different margin of 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 assessments 
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.
    Based on the acute toxicity and pathogenicity data discussed in 
Unit III.B., as well as the ubiquity of Trichoderma hamatum isolate 382 
in the environment without reported adverse effects to humans, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the United States population, including infants and children, from 
aggregate exposure to the residues of Trichoderma hamatum isolate 382. 
This includes all anticipated dietary exposures and all other exposures 
for which there is reliable information. The Agency has arrived at this 
conclusion because the data and information available on Trichoderma 
hamatum isolate 382 do not demonstrate toxic, pathogenic, and/or 
infective potential to mammals. Thus, there are no threshold effects of 
concern and, as a result, an additional margin of safety is not 
necessary.

VII. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since 
the Agency is establishing an exemption from the requirement of a 
tolerance without any numerical limitation.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. In this 
context, EPA considers the international maximum residue limits (MRLs) 
established by the Codex Alimentarius Commission (Codex), as required 
by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United 
Nations Food and Agriculture Organization/World Health Organization 
food standards program, and it is recognized as an international food 
safety standards-setting organization in trade agreements to which the 
United States is a party. EPA may establish a tolerance that is 
different from a Codex MRL; however, FFDCA section 408(b)(4) requires 
that EPA explain the reasons for departing from the Codex level.
    The Codex has not established a MRL for Trichoderma hamatum isolate 
382.

C. Response to Comments

    One comment, which specifically stated that the petition should be 
rejected without full testing for 20 years, was received in response to 
the notice of filing. The Agency notes that the data requirements do 
not require 20 years of testing, and no current information available 
to EPA suggests the need for 20 years worth of data to characterize the 
pesticide's toxicity, infectivity and/or pathogenicity. For the 
proposed uses of the microbial active ingredient (i.e., applications to 
or incorporation into soilless potting media or compost), the Agency 
has concluded that there is a reasonable certainty that no harm will 
result to the United States population, including infants and children, 
from aggregate exposure to the residues of Trichoderma hamatum isolate 
382. Thus, under the standard in FFDCA section 408(c)(2), an exemption 
from the requirement of a tolerance for residues of Trichoderma hamatum 
isolate 382 is appropriate.

VIII. Conclusions

     The Agency concludes that there is a reasonable certainty that no 
harm will result to the United States population, including infants and 
children, from aggregate exposure to residues of Trichoderma hamatum 
isolate 382. Therefore, an exemption is established for residues of 
Trichoderma hamatum isolate 382 in or on all food commodities when 
applied as a fungicide and used in accordance with good agricultural 
practices.

IX. Statutory and Executive Order Reviews

    This final rule establishes a tolerance exemption under section 
408(d) of 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 final 
rule has been exempted from review under Executive Order 12866, this 
final rule is not subject to Executive Order 13211, entitled Actions 
Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001), or Executive Order 
13045, entitled Protection of Children from Environmental Health Risks 
and Safety Risks (62 FR 19885, April 23, 1997). 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., 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).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the tolerance 
exemption in this final rule, do not require the issuance of a proposed 
rule, the requirements of the Regulatory Flexibility Act (RFA) (5 
U.S.C. 601 et seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes. As a result, 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 FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999), and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 9, 2000), do not apply to this final rule. In addition, 
this final rule does not 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).
    This action does not involve any technical standards that would 
require

[[Page 43076]]

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).

X. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report 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: July 14, 2010.
Steven Bradbury,
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 180.1298 is added to subpart D to read as follows:

Sec.  180.1298  Trichoderma hamatum isolate 382; exemption from the 
requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of Trichoderma hamatum isolate 382 in or on all food 
commodities when applied as a fungicide and used in accordance with 
good agricultural practices.

[FR Doc. 2010-18076 Filed 7-22-10; 8:45 am]
BILLING CODE 6560-50-S