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Coniothyrium minitans strain CON/M/91-08 - Exemption of Tolerance Requirement 3/01

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301107; FRL-6772-1]
RIN 2070-AB78

Coniothyrium minitans Strain CON/M/91-08; 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 Coniothyrium minitans strain CON/M/
91-08 on all food commodities when applied/used according to label
instructions. Prophyta Biologischer Pflanzenschutz Gmbh submitted a
petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA),
as amended by the Food Quality Protection Act (FQPA) 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 Coniothyrium minitans strain CON/M/91-08.

DATES:  This regulation is effective March 28, 2001. Objections and
requests for hearings, identified by docket control number OPP-301107,
must be received by EPA, on or before May 29, 2001.

ADDRESSES:  Written objections and hearing requests may be submitted by
mail, electronically, or in person. Please follow the detailed
instructions for each method as provided in Unit IX. of the
SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, your
objections and hearing requests must identify docket control number
OPP-301107 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:  By mail: Susanne Cerrelli, c/o
Product Manager (PM) 90, Biopesticides and Pollution Prevention
Division (7511C), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460; telephone number: (703) 308-8077; and
e-mail address: cerrelli.susanne@epa.gov.

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
           Categories                 NAICS codes         Potentially
                                                      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 under FOR FURTHER INFORMATION
CONTACT.

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, " "Regulations and Proposed Rules," 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/. A frequently

updated electronic version of 40 CFR part 180 is available at http;//
www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a
beta site currently under development.
    2. In person. The Agency has established an official record for
this action under docket control number OPP-301107. 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.

II. Background and Statutory Findings

     In the Federal Register of January 24, 2000 (65 FR 3696) (FRL-
6484-9), EPA issued a notice pursuant to section 408 of the Federal
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e), as amended by
the Food Quality Protection Act (FQPA) (Public Law 104 -170) announcing
the filing of a pesticide tolerance petition by Prophyta Biologischer
Pflanzenschutz GmbH, Inselstrabe 12, D-23999 Malchow/Poel, Germany.
This notice included a summary of the petition prepared by the
petitioner Prophyta Biologischer Pflanzenschutz GmbH.

     The petition requested that 40 CFR part 180 be amended by
establishing an exemption from the requirement of a tolerance for
residues of Coniothyrium minitans strain CON/M/91-08. Three comments
were received after close of the comment period which expressed support
of this registration as an additional product for controlling white
mold in snap beans.

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 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.

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.
     Coniothyrium minitans is ubiquitous in the environment. This
fungus was first described by Campbell (1947), after being isolated
from sclerotia in California. A pesticide product containing
Coniothyrium minitans strain CON/M/91-08 is currently registered in
Germany and Switzerland. No toxicological or pathogenic effects by C.
minitans in mammals have been reported in available public literature.
Furthermore, Prophyta Biologischer Pflanzenschutz Gmbh has submitted
several acute toxicity studies (eye, dermal, oral, and intraperitoneal)
using a dose greater than 107 colony forming units (CFU) of
Coniothyrium minitans strain CON/M/91-08, with no adverse effects being
observed (NOAEL). In addition, certain biological characteristics of
Coniothyrium minitans strain CON/M/91-08, which include, its
temperature requirements for germination and mycelium growth, and its
dependence on Sclerotinia as a host are further indications that this
organism is not pathogenic to mammals. The C. minitans data submitted
demonstrated no conidia germination at 30  deg.C or above, and no
mycelium growth at 33  deg.C or above. Therefore, the use of this
fungus does not appear to have any risk of adverse effects to mammals.
A more detailed discussion of the data submitted in support of this
tolerance exemption and the associated registration action as well as
any data waivers that were granted by the Agency may be found in the
Biopesticides Registration Action Document for Coniothyrium minitans
strain CON/M/91-08, which has been placed in the official record for
this action.

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 ground water or surface water and exposure through
pesticide use in gardens, lawns, or buildings (residential and other
indoor uses).

A. Dietary Exposure

    1. Food. Dietary exposure is expected to be minimal because the
microbial product is incorporated in the soil prior to planting or
after harvest. Thus no increase in fungal exposure is anticipated. In
addition, standard practices of washing, peeling, cooking, or
processing fruits and vegetables will reduce residues of Coniothyrium
minitans strain CON/M/91-08 and further minimize dietary exposure. The
risk posed to adults, infants and children is likely to be minimal
because of the low acute toxicity of the microbial pesticide and no
reported cases in the literature of disease or injury to humans.
    2. Drinking water exposure. A submitted study showed that the
likelihood for C. minitans passage through a soil medium to ground
water is minimal to none. Also, the survival of C. minitans in a
municipal water treatment is unlikely. Furthermore, the results of the
acute toxicity studies using a high dose of the fungus suggest there
will not be any adverse effects to humans and there have been no
reported cases in the literature of disease or injury to humans.

B. Other Non-Occupational Exposure

     Coniothyrium minitans is a naturally-occurring fungus. Dermal and
inhalation exposure to C. minitans pesticide product is expected to be
limited to those who apply or handle the pesticide in an agricultural
environment. Therefore, no other non-occupational exposure is expected.

VI. Cumulative Effects

     No mechanism of toxicity in mammals has been identified for
Coniothyrium minitans strain CON/M/91-08. Therefore no cumulative
effect with other related organisms is anticipated. Because the data
demonstrate low toxicity/pathogenicity potential of the active
ingredient, the likelihood of adverse dietary or cumulative effects is
expected to be minimal.

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

     Soil microorganisms, such as C. minitans, are naturally occurring
and ubiquitous in the environment, with a highly probable, prior human
exposure. Furthermore, the toxicity testing conducted by Prophyta
Biologischer Pflanzenschutz Gmbh indicates an inability of the microbe
to grow at or above 33  deg.C and a lack of potential toxic,
pathogenic, allergic effects to humans. In addition, no potential for
toxic or pathogenic effects of C. minitans to mammals including humans
was reported in published literature. Further, there is no evidence
which suggests that aggregate exposure of either adults or infants and
children to C. minitans leads to any harm. Accordingly, EPA concludes
that there is a reasonable certainty that no harm will result from
aggregate exposure to the U.S. population or any significant
subpopulation, including infants and children, to residues of
Coniothyrium minitans strain CON/M/91-08. This includes all anticipated
dietary exposures and all other exposures for which there is reliable
information.
     FFDCA section 408 provides that EPA shall apply an additional ten-
fold margin of exposure (safety) for infants and children in the case
of threshold effects to account for prenatal and postnatal toxicity and
the completeness of the data base, unless EPA determines that a
different margin of exposure (safety) will be safe for infants and
children. Margins of exposure (safety) are often referred to as
uncertainty (safety) factors. In this instance, the Agency believes
there is reliable data to support the conclusion that this microbial
agent is practically non-toxic to mammals, including infants and
children, and, thus, there are no threshold effects; therefore, EPA has
not used a margin of exposure (safety) approach to assess the safety of
Coniothyrium minitans strain CON/M/91-08. As a result, the provision
requiring an additional margin of exposure (safety) does not apply.

VIII. Other Considerations

A. Endocrine Disruptors

     Within the available scientific literature, there are no reports
to suggest or indicate that C. minitans has the potential to cause an
adverse effects on the endocrine and/or immune systems of animals.

B. Analytical Method

     The Agency proposes to establish an exemption from the requirement
of a tolerance without any numerical limitation; therefore the Agency
has concluded that an analytical method is not required for enforcement
purposes for Coniothyrium minitans strain CON/M/91-08.

C. Codex Maximum Residue Level

     There are no CODEX values for Coniothyrium minitans strain CON/M/
91-08.

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 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-301107 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 May 29,
2001.
    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 Rm. C400, 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 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 tompkins.jim@epa.gov,
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.
     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.
    3. Copies for the docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit IX.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.2. Mail your
copies, identified by docket number OPP-301107, 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.
In person or by courier, bring a copy to the location of the PIRIB
described in Unit I.B.2. You may also send an electronic copy of your
request via e-mail to: opp-docket@epa.gov. Please use an ASCII file
format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

     A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).

X. Regulatory Assessment Requirements

     This final rule establishes an exemption from the tolerance
requirement under FFDCA section 408(d) 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). 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 FFDCA
section 408(d), 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 FFDCA section 408(n)(4). 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.

XI. Submission to Congress and the Comptroller General

     The Congressional Review Act, 5 U.S.C. 801 et seq., as added by
the Small Business Regulatory Enforcement Fairness Act of 1996,
generally provides that before a rule may take effect, the agency
promulgating the rule must submit a rule report, which includes a copy
of the rule, to each House of the Congress and to the Comptroller
General of the United States. EPA will submit a report containing this
rule and other required information to the U.S. Senate, the U.S. House
of Representatives, and the Comptroller General of the United States
prior to publication of this final rule in the Federal Register. This
final rule is not a "major rule " as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

     Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: March 15, 2001.
Anne E. Lindsay,
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 180.1213 is added to subpart D to read as follows:

Sec. 180.1213  Coniothyrium minitans strain CON/M/91-08; exemption from
the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for
residues of the microbial pesticide Coniothyrium minitans strain CON/M/
91-08 when used in or on all food commodities.

[FR Doc. 01-7645 Filed 3-27 -01; 8:45 am]
BILLING CODE 6560-50-S