[Federal Register Volume 65, Number 121 (Thursday, June 22, 2000)]
[Rules and Regulations]
[Pages 38753-38757]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-15723]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300924; FRL-6383-7]
RIN 2070-AB78


Trichoderma Harzianum Rifai Strain T-39; 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 Trichoderma harzianum Rifai strain T-39 
on all food commodities when applied/used as ground and certain foliar 
applications. Makhteshim Agan of North America submitted a petition to 
EPA under the Federal Food, Drug, and Cosmetic Act, as amended by the 
Food Quality Protection Act of 1996 requesting an exemption from the 
requirement of a tolerance. This regulation eliminates the need to 
establish a maximum permissible level for residues of Trichoderma 
harzianum Rifai strain T-39.

DATES:  This regulation is effective June 22, 2000. Objections and 
requests for hearings, identified by docket control number OPP-300924, 
must be received by EPA on or before August 21, 2000.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VIII. of the ``SUPPLEMENTARY 
INFORMATION'' section. To ensure proper receipt by EPA, your objections 
and hearing requests must identify docket control number OPP-300924 in 
the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Shanaz Bacchus, Biopesticides 
and Pollution Prevention Division (7511C), Office of Pesticide 
Programs, Environmental Protection Agency, Ariel Rios Bldg., 1200 
Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 703-
308-8097; and e-mail address: <a href="/cdn-cgi/l/email-protection#0b696a6868637e782578636a656a714b6e7b6a256c647d"><span class="__cf_email__" data-cfemail="62000301010a17114c110a030c0318220712034c050d14">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

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

    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed in the ``FOR FURTHER INFORMATION 
CONTACT'' section.

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations'' and then look up the entry for this document under the 
``Federal Register--Environmental Documents.'' You can also go directly 
to the Federal Register listings at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-300924. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

[[Page 38754]]

II. Background and Statutory Findings

    In the Federal Register of June 26, 1998 (63 FR 34390-34392) (FRL-
5794-9), EPA issued a notice pursuant to section 408 of the Federal 
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the 
Food Quality Protection Act (FQPA) (Public Law 104-170) announcing the 
filing of a pesticide tolerance petition by Makhteshim Agan of North 
America, (hereafter referred to as MANA), 551 Fifth Avenue, Suite 1100, 
New York, NY 10176. This notice included a summary of the petition 
prepared by the petitioner, MANA. There were no comments received in 
response to the notice of filing.
    The petition requested that 40 CFR part 180 be amended by 
establishing an exemption from the requirement of a tolerance for 
residues of Trichoderma harzianum Rifai strain T-39.

III. Risk Assessment

    New Section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the tolerance is ``safe.'' Section 408(c)(2)(A)(ii) defines ``safe'' to 
mean that ``there is a reasonable certainty that no harm will result 
from aggregate exposure to the pesticide chemical residue, including 
all anticipated dietary exposures and all other exposures for which 
there is reliable information.'' This includes exposure through 
drinking water and in residential settings, but does not include 
occupational exposure. Section 408(b)(2)(C) requires EPA to give 
special consideration to exposure of infants and children to the 
pesticide chemical residue in establishing a tolerance and to ``ensure 
that there is a reasonable certainty that no harm will result to 
infants and children from aggregate exposure to the pesticide chemical 
residue...'' Additionally, section 408(b)(2)(D) requires that the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residue 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 us in residential settings.

IV. 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.
    Trichoderma harzianum strain T-39 was considered neither toxic nor 
pathogenic based on the results of the Tier I toxicology studies. Tier 
II and Tier III studies were not required because the results from the 
Tier I studies were sufficient to satisfy guideline requirements. On 
the basis of the studies submitted, it was considered a Toxicity 
Category III pesticide for acute oral effects due to the amount dosed 
only, and Toxicity Category IV for dermal and primary dermal irritation 
health effects. These and additional toxicology studies are summarized 
below.
    1. Acute oral infectivity/pathogenicity. Based on the submitted 
data, Trichoderma harzianum strain T-39 demonstrated a low toxicity 
profile. It was not infectious, pathogenic or toxic to rats when 
administered orally at 1.4 to 2.0  x  10<SUP>8</SUP> colony forming 
units (cfu) per animal. Clearance and infectivity were evaluated in the 
brain, blood, lymph nodes, kidney, liver, spleen, lungs, caecum and 
feces. The microbe was detected only in fecal samples, and in those 
samples a distinct clearance pattern was demonstrated throughout the 
study.
    2. Acute dermal toxicity. A single 1,150-1,570 mg/kg dose of 
Trichoderma harzianum was applied dermally for a 24 hour exposure 
period to rabbits. There were no clinical signs of toxicity and no 
effects on mortality or body weight nor any signs of dermal irritation 
during the study. The available information indicates that dermal 
toxicity is not likely to occur with Trichoderma harzianum strain T-39.
    3. Primary Dermal Irritation Study. A dermal application of 0.5g of 
Trichoderma harzianum strain T-39 at 5  x  10<SUP>9</SUP> cfu/g 
produced no dermal response in rabbits after a 4-hour exposure period. 
The results of this study are classified as Supplementary, but taken in 
conjunction with the acute dermal toxicity study, the microbial 
pesticide is likely to be mildly irritating to skin. The pesticide was 
classified as Toxicity Category IV for primary dermal irritation 
effects.
    4. Skin sensitization in guinea pig. Under the conditions of this 
study, Trichoderma harzianum strain T-39 in physiological saline was 
applied in occluded dermal patches. This study demonstrated potential 
delayed contact hypersensitivity in guinea-pigs. This study was 
designed to meet the requirements of the OECD Guidelines for Testing 
Chemicals, and was submitted in support of fulfilling EPA data 
requirements for hypersensitivity incidents. While the study is not a 
substitute for reporting hypersensitivity incidents, it was considered 
acceptable. However, the registrant must report any hypersensitivity 
incidents to the Agency. The label must indicate that products 
containing this active ingredient are likely to demonstrate a potential 
for dermal sensitization.
    5. Primary eye irritation. Three eye irritation studies were 
submitted. Two acute eye irritation studies were conducted using 
undiluted TGAI on a single male rabbit each time. The studies indicated 
a potential for severe eye irritation, placing the undiluted TGAI in 
acute Toxicity Category I. In one study, a single dose of 0.1g of the 
active ingredient, approximately 5  x  10<SUP>8</SUP> cfu, was used to 
treat one rabbit. The results indicated that the microbial pest control 
agent (MPCA) TGAI, Trichoderma harzianum strain T-39, has the potential 
to cause serious ocular damage. The active ingredient was a severe eye 
irritant. In another study a single dose of 0.1g was administered into 
the everted lower right eyelid of a sentinel male rabbit. The results 
of this study indicated that a 3 minute, 180 ml saline rinse, applied 3 
minutes post dosing, had no ameliorating effect on the irritancy of the 
active ingredient. The adhesion of the TGAI to the conjunctivae 
remained a serious effect of treatment even after rinsing.
    However, another eye irritation study was done in which the test 
material was the End-use Product (EP), Trichodex. Six male rabbits were 
treated with a single dose of 0.1 ml (0.04 g) of Trichodex-EP into the 
everted lower right eyelid. The maximum average irritation score was 
determined to be 15.3 at 24 hours post dosing. There was no corneal 
involvement after 72 hours and ocular irritation was no longer present 
after 7 days, equivalent to a mildly irritating, or an acute Toxicity 
Category III rating for the EP. This study was considered acceptable 
and can be used for labeling of the EP. Workers, who are most likely to 
be exposed to the pesticide during mixing/loading, application and post 
application activities, are required to wear goggles to mitigate 
against potential eye irritation.
    6. Acute intraperitoneal toxicity/pathogenicity. Under conditions 
of this study the LD<INF>50</INF> for the EP, Trichodex,

[[Page 38755]]

administered via intraperitoneal injection was 644 mg/Kg in male rats, 
1.087 mg/Kg in female rats and 806 mg/Kg for combined results from male 
and female rats. The lowest dose administered, 1.5  x  10<SUP>7</SUP> 
cfu/animal, showed no indications of significant adverse effects. This 
study was considered acceptable and is a substitute for the intravenous 
study with fungi as active pesticidal ingredients.
    7. Acute pulmonary toxicity/pathogenicity. Small 2 mm pale raised 
areas were found in the lungs of some animals of both genders treated 
with test material containing the active fungi. However, minimal 
clinical signs and no deaths were observed. There were no significant 
macroscopic lesions found in any test animals in the other experimental 
groups. The active ingredient was not found in samples of liver, brain, 
spleen, kidneys, lymph nodes or blood. Microbial clearance through the 
caecum was evident. Although there was no evidence of the reproduction 
of the microbe in the tissues, colony forming units persisted in the 
lungs of animals treated with the active fungus. However, no adverse 
effects were seen even in the absence of lung clearance by day 21. 
Based on this study the TGAI was classified as Toxicity Category III. 
Because the predominant inert ingredient is known to have associated 
irritation and inhalation effects, the microbial, EP was classified as 
an acute Toxicity Category II pesticide or likely to be a moderate 
acute inhalation hazard. Workers who are most likely to be exposed 
during mixing/loading, application and post application activities are 
required to wear the recommended respirators with NIOSH prefixes, N-95, 
P-95 or R-95, to mitigate against exposure.
    8. Mouse Micronucleus Test. This study is not required under the 
guidelines for registration of microbials but was submitted by the 
registrant for consideration of the application. A preliminary toxicity 
test using doses of 2,500 and 5,000 mg/Kg resulted in no deaths and no 
significant chromosome damage. Subsequently, the main study was carried 
out with administration of Trichodex suspended in 0.5% methyl cellulose 
solution by oral gavage. Doses were 200, 1,000, or 5,000 mg/kg. Under 
conditions of this test, there was no evidence of chromosomal damage 
leading to micronucleus formation in polychromatic erythrocytes of 
treated mice 24, 48, or 72 hours after dosing. The study was rated 
supplemental.

V. Aggregate Exposures

    In examining aggregate exposure, FFDCA section 408 directs EPA to 
consider available information concerning exposures from the pesticide 
residue in food and all other non-occupational exposures, including 
drinking water from groundwater 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 is likely to occur. The 
lack of acute oral toxicity/pathogenicity, and the ubiquitous nature of 
the microbial, support the establishment of an exemption from the 
requirement of a tolerance for Trichoderma harzianum strain T-39.
    1. Food. The microbial pesticide can be removed from foods by 
washing, peeling, cooking and processing. Dietary exposure to the 
microbial and the risk posed to adults, infants and children are likely 
to be minimal, because of the low acute oral toxicity/pathogenicity 
potential of the microbial pesticide.
    2. Drinking water exposure. Oral exposure, at very low levels, may 
occur from ingestion of drinking water. Drinking water is not being 
screened for Trichoderma harzianum as a potential indicator of 
microbial contamination. Both percolation through soil and municipal 
treatment of drinking water would reduce the possibility of exposure to 
the fungal active ingredient through drinking water. Therefore, the 
potential of significant transfer of residues to drinking water is 
minimal to non-existent. Even if negligible oral exposure should occur 
through drinking water, the Agency concludes that such exposure would 
present no risk due to the lack of acute oral toxicity/pathogenicity 
and the ubiquitous nature of the microbe.

B. Other Non-Occupational Exposure

    Dermal and inhalation exposure. Dermal and inhalation exposures and 
risks to adults, infants and children via treated lawns or recreational 
areas are not likely if the pesticide is applied as labeled. However, 
should such exposures occur, adverse effects via the dermal and 
inhalation routes are expected to be minimal based on the low toxicity 
potential of this naturally occurring, ubiquitous microbe.

VI. Cumulative Effects

    There are other species and strains of Trichoderma registered. The 
Agency has received information to distinguish strain T-39 from other 
registered strains. It is not clear to the Agency whether the 
registered strains share a common mechanism of toxicity, or any 
mechanism of toxicity with strain T-39. Because the data available 
demonstrate a low toxicity/pathogenicity potential of the active 
ingredient, the likelihood of adverse dietary effects is expected to be 
minimal.

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

    Based on the information in this preamble, EPA concludes that there 
is a reasonable certainty of no harm from aggregate exposure to the 
U.S. population to Trichoderma harzianum Rifai strain T-39 residues. 
This includes all anticipated dietary exposures and all other exposures 
for which there is reliable information. The Agency has imposed 
appropriate risk mitigation measures to protect the at-risk worker 
population from potential eye irritation and acute pulmonary effects. 
These include goggles and appropriate dust-mist filtering respirators 
which comply with the Worker Protection Standards.

VIII. Other Considerations

A. Endocrine Disruptors

    EPA does not have any information regarding endocrine effects of 
this microbial pesticide at this time. There is no evidence to suggest 
that use of Trichoderma harzianum strain T-39 at the proposed 
concentrations will adversely affect the endocrine system.

B. Analytical Method(s)

    As part of the standard Quality Control measures, the Agency is 
requiring microbial assays and analytical methods to identify the 
active ingredient and potential contaminants. Analytical methods are 
available and sufficient to identify metabolites and contaminants 
within regulatory levels. All batches containing potential human 
pathogens are to be destroyed.

C. Codex Maximum Residue Level

    There are no Codex Maximum Residue Levels or exemption from 
tolerances for the microbial active ingredient Trichoderma harzianum 
strain T-39. There is an exemption from tolerance on all food 
commodities except mushrooms for another strain of Trichoderma 
harzianum, Rifai strain KRL-AG2, in the United States.

IX. 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

[[Page 38756]]

submission of objections and requests for hearings appear in 40 CFR 
part 178. Although the procedures in those regulations require some 
modification to reflect the amendments made to the FFDCA by the FQPA of 
1996, EPA will continue to use those procedures, with appropriate 
adjustments, until the necessary modifications can be made. The new 
section 408(g) provides essentially the same process for persons to 
``object'' to a regulation for an exemption from the requirement of a 
tolerance issued by EPA under new section 408(d), as was provided in 
the old FFDCA sections 408 and 409. However, the period for filing 
objections is now 60 days, rather than 30 days.

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

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket control number OPP-300924 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 
21, 2000.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900), 
Environmental Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania 
Ave., NW., Washington, DC 20460. You may also deliver your request to 
the Office of the Hearing Clerk in Room C-400, Waterside Mall, 401 M 
St., SW., Washington, DC 20460. The Office of the Hearing Clerk is open 
from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. 
The telephone number for the Office of the Hearing Clerk is (202) 260-
4865.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission be 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 <a href="/cdn-cgi/l/email-protection#02766d6f72696b6c712c686b6f426772632c656d74"><span class="__cf_email__" data-cfemail="bcc8d3d1ccd7d5d2cf92d6d5d1fcd9ccdd92dbd3ca">[email protected]</span></a>, 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., 
Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, Ariel Rios Bldg., 
1200 Pennsylvania Ave., NW., Washington, DC 20460.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VIII.A. of 
this preamble, you should also send a copy of your request to the PIRB 
for its inclusion in the official record that is described in Unit 
I.B.2. of this preamble. Mail your copies, identified by docket number 
OPP-300924, to: Public Information and Records Integrity Branch, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, Ariel Rios Bldg., 
1200 Pennsylvania Ave., NW., Washington, DC 20460. In person or by 
courier, bring a copy to the location of the PRIB described in Unit 
I.B.2. of this preamble. You may also send an electronic copy of your 
request via e-mail to: <a href="/cdn-cgi/l/email-protection#4a253a3a672e2529212f3e0a2f3a2b642d253c"><span class="__cf_email__" data-cfemail="553a252578313a363e3021153025347b323a23">[email protected]</span></a>. 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 file format 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).

X. Regulatory Assessment Requirements

    This final rule will establish an exemption from the tolerance 
requirement under FFDCA section 408(e). The Office of Management and 
Budget (OMB) has exempted these types of actions from review under 
Executive Order 12866, entitled Regulatory Planning and Review (58 FR 
51735, October 4, 1993). This action 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 prior consultation as specified by Executive Order 
13084, entitled Consultation and Coordination with Indian Tribal 
Governments (63 FR 27655, May 19,1998); special considerations as 
required by Executive Order 12898, entitled Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994); or require 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). Pursuant to the Regulatory Flexibility Act (RFA) 
(5 U.S.C. 601 et seq.), the Agency previously assessed whether 
establishing tolerances, exemptions from tolerances, raising tolerance 
levels or expanding exemptions might adversely impact small entities 
and concluded, as a generic matter, that

[[Page 38757]]

there is no adverse economic impact. The factual basis for the Agency's 
generic certification for tolerance actions published on May 4, 1981 
(46 FR 24950), and was provided to the Chief Counsel for Advocacy of 
the Small Business Administration. 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 rule 
directly regulates growers, food processors, food handlers and food 
retailers, not States. This action does not alter the relationships or 
distribution of power and responsibilities established by Congress in 
the preemption provisions of FFDCA section 408(n)(4).

XI. Submission to Congress and the General Accounting Office

    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 25, 2000.
Susan B. Hazen,
Acting Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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


    2. Section 180.1201 is revised to read as follows:


Sec. 180.1201  Trichoderma harzianum strain T-39; exemption from the 
requirement of a tolerance.

    Trichoderma harzianum strain T-39 is exempt from the requirement of 
a tolerance on all food commodities.

[FR Doc. 00-15723 Filed 6-21-00; 8:45 am]
BILLING CODE 6560-50-F


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