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B. bassiana - Tolerance Exemption 4/99

[Federal Register: April 28, 1999 (Volume 64, Number 81)]
[Rules and Regulations]
[Page 22793-22796]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28ap99-6]

[[Page 22793]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300821; FRL-6068-7]
RIN 2070-AB78

Beauveria bassiana (ATCC #74040); Exemption from the Requirement
of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This rule establishes an exemption from the requirement of a
tolerance for residues of the Beauveria bassiana (ATCC #74040) in or on
all food commodities when applied or used as ground and aerial foliar
sprays for use only on terrestrial crops. TROY Biosciences,
Incorporated, 2620 North 37th Drive, Phoenix, Arizona 85009, submitted
an amended petition PP 5F4483 to EPA under the Federal Food, Drug and
Cosmetic Act as amended by the Food Quality Protection Act of 1996
(Pub. L. 104-170) requesting the exemption from tolerance. This
regulation eliminates the need to establish a maximum permissible level
for residues of Beauveria bassiana (ATCC #74040) in or on all food
commodities.

DATES: This regulation is effective April 28, 1999. Objections and
requests for hearings must be received by EPA on or before June 28,
1999.

ADDRESSES: Written objections and hearing requests, identified by the
docket control number [OPP-300821], must be submitted to: Hearing Clerk
(1900), Environmental Protection Agency, Rm. M3708, 401 M St., SW.,
Washington, DC 20460. Fees accompanying objections and hearing requests
shall be labeled "Tolerance Petition Fees" and forwarded to: EPA
Headquarters Accounting Operations Branch, OPP ("Tolerance Fees" and
forwarded to: EPA Headquarters Accounting Operations Branch, OPP
(Tolerance Fees), P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any
objections and hearing requests filed with the Hearing Clerk identified
by the docket control number, [OPP-300821], must also be submitted to:
Public Information and Records Integrity Branch, Information Resources
and Services Division (7502C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
In person, bring a copy of objections and hearing requests to Rm. 119,
CM #2, 1921 Jefferson Davis Hwy., Arlington, VA.
    A copy of objections and hearing requests filed with the Hearing
Clerk may be submitted electronically by sending electronic mail (e-
mail) to: opp-docket@epamail.epa.gov. Copies of electronic objections
and hearing requests must be submitted as an ASCII file avoiding 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 5.1/6.1 file format or ASCII file format. All
copies of electronic objections and hearing requests must be identified
by the docket number [OPP-300821]. No Confidential Business Information
(CBI) should be submitted through e-mail. Copies of electronic
objections and hearing requests on this rule may be filed online at
many Federal Depository Libraries.

FOR FURTHER INFORMATION CONTACT: By mail: Shanaz Bacchus, c/o Product
Manager (PM) 90, Biopesticides and Pollution Prevention Division
(7511C), Environmental Protection Agency, 401 M St., SW, Washington, DC
20460. Office location, telephone number and e-mail address: Rm.
902W34, CM #2, 1921 Jefferson Davis Highway, Arlington, VA 22202, (703)
308-8097; e-mail: bacchus.shanaz@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: In the Federal Register of June 10, 1998, 63
FR 31771) (FRL-5793-4), EPA issued a notice pursuant to section 408 of
the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e)
announcing the filing of a pesticide tolerance petition by TROY
Biosciences, Incorporated, 2620 North 37th Drive, Phoenix, Arizona
85009. This notice included a summary of the petition prepared by the
petitioner and this summary contained conclusions and arguments to
support its conclusion that the petition complied with the Food Quality
Protection Act (FQPA) of 1996.
    The petition requested that 40 CFR part 180 be amended by
establishing an exemption from the requirement of a tolerance for
residues of the microbial insecticidal agent Beauveria bassiana (ATCC
#74040) in or on all food commodities.
    A comment was received in response to the notice of filing
regarding the potential for Beauveria bassiana (B. bassiana) to
colonize corn and infect lungs of wild rodents and nasal passages of
humans. The comment also referred to the potentially hazardous effects
of beauvericin, a metabolite associated with this microbial pesticide.
While Beauveria bassiana may infect corn, the acute oral toxicity/
pathogenicity studies indicate no undue risk to humans, children and
infants from dietary exposure. The data submitted in support of
guideline requirements for plants suggest that other plants, including
corn, are not likely to be at risk if the pesticide is used as labeled.
Also, the acute oral and pulmonary toxicity/pathogenicity studies of
the technical grade active ingredient indicate that it is neither toxic
nor pathogenic to mammals or humans. The registrant has provided
analytical methods and quality assurance procedures to control
beauvericin, a potential metabolite, within regulatory levels. The data
which were submitted for this petition were evaluated by the Agency and
are sufficient to support the exemption from the requirement of a
tolerance in or on all food commodities. A summary discussion of the
reviews of the data submitted in support of this petition follows.

I. Risk Assessment and Statutory Findings

    New section 408(b)(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.

[[Page 22794]]

II. Toxicological Profile

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed
most of 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.
    Results of the following studies support the lack of toxicity/
pathogenicity of the Technical Grade Active Ingredient (TGAI),
Beauveria bassiana (ATCC #74040).

A. Product Chemistry

    The data submitted for product identity of the active ingredient,
Beauveria bassiana (ATCC #74040), and end use product, are sufficient
to support the request for the proposed exemption from the requirement
of a tolerance. The active ingredient is a naturally-occurring fungus
which can be found in the United States and in the environment
worldwide.
    The registrant proposed sufficient quality assurance methods to
control unintentional ingredients and contaminants in the proposed
products within regulatory levels. Batches containing human pathogens
are to be destroyed. Beauvericin levels in the technical grade active
ingredient are not likely to exceed 60 ppm. The registrant has
voluntarily withdrawn the registration of an old formulation, which had
potential aflatoxin contamination present in an inert ingredient. The
proposed new formulation has met the Agency's guideline requirements
for microbial pesticides for food use.

B. Toxicology

    1. Acute oral toxicity/pathogenicity in rats, (Technical). No
animal mortality or overt toxic effects were noted in rats dosed orally
with 1.9 x 108 colony forming units (cfu)/animal of B.
bassiana (ATCC #74040). Red foci were noted on the lungs of three of
the treated animals indicating possible pulmonary toxicity. However,
the acute pulmonary toxicity/pathogenicity study confirmed clearance
from the lungs as discussed below. Based on these studies, and the
nature of the inerts in the sole registered microbial end use product
(EP) containing this active ingredient, the EP can be considered a
Toxicity Category IV pesticide.
    2. Acute dermal toxicity in rabbits, (Naturalis-L 225). B. bassiana
(ATCC #74040) was not pathogenic, infective or toxic in rabbits dosed
dermally at 2 gm per animal containing 4.2 x 107 cfu/ml. It
was therefore considered Toxicity Category IV for dermal toxicity.
    3. Acute pulmonary toxicity/pathogenicity in rats, (Technical). No
mortality or toxic or pathogenic effects were found in the test animals
dosed intratracheally with 2.5 x 109 cfu B. bassiana (ATCC
#74040)/animal. Clearance was complete from the lungs within 15 days of
dosing. No significant clinical signs were observed. Brown or tan
lesions were noted in the lungs of all treated animals starting on day
4 and an inflammatory response was evident in microscopic examination
until day 22. The presence of an inflammatory response is expected as a
component of the normal recognition and clearance of microbes by the
immune system. No inflammation was evident on tissues examined at the
end of the study.
    4. Acute intraperitoneal toxicity/pathogenicity testing in rats,
(Technical). B. bassiana (ATCC #74040) was not pathogenic, infective or
toxic in rats when dosed intraperitoneally with 2 x 107 cfu/
animal. No animals had the test microbe recovered from their blood or
had visible lesions on their internal organs at gross necropsy.
    5. Primary eye irritation in rabbits, (Naturalis-L 225). Rabbits
displayed minimal ocular irritation when given a single 0.1 ml ocular
dose containing 2 x 106 cfu. Based on these data, the
pesticide was considered acute Toxicity Category III for eye
irritation.
    6. Primary dermal irritation in rabbits, (Naturalis-L 225). There
was no mortality or significant toxic effects in animals singly dosed
and exposed for four hours with 5 ml B. bassiana (ATCC #74040)
containing 5.5 x 107 cfu. Based on these data, microbial
pesticide was considered Toxicity Category IV for primary dermal
irritation effects.
    7. Dermal sensitization. Data provided to the Agency show that
Naturalis-L is a dermal sensitizer. In several animals, the severity of
irritation required relocation of test site for inductions 8 and 9. In
addition, two animals died during the study - one prior to the
challenge phase and one prior to the 48-hour challenge scoring
interval. No cause for death was determined. This test was conducted
with a test material at 100% concentration rather than at the 50%
concentration recommended by the OPPTS harmonized guidelines. The label
for this product must state that it is a dermal sensitizer and proper
protection equipment should be worn.
    8. Hypersensitivity incidents. No incidents of hypersensitivity
have been reported for this microbial pesticide.

III. Aggregate Exposures and Risk

    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 and Risk

    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 exemption from the requirement of a
tolerance for this active ingredient.
    1. Food. The microbial pesticide can be easily removed from foods
by washing, peeling, cooking and processing. Even if ingested, the low
acute oral toxicity potential indicates minimal risk. Consequently,
dietary exposure to the microbial and the risk posed by ingestion of
foods treated with the microbial pesticide, are likely to be minimal
for adults, infants and children by the oral route.
    2. Drinking water exposure. The microorganism Beauveria bassiana is
common in the soil. It is not known as an aquatic microorganism, and
therefore is not expected to proliferate in aquatic habitats. Drinking
water is not being screened for Beauveria bassiana (ATCC #74040) as a
potential indicator of microbial contamination. Both percolation
through soil and municipal treatment of drinking water would reduce the
possibility of exposure to Beauveria bassiana (ATCC #74040) through
drinking water. Therefore, the potential of significant transfer to
drinking water is minimal to nonexistent. However, 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 toxicity
and the ubiquitous nature of the microbe.

B. Other Non-Occupational Exposure

    Dermal and inhalation exposure and risk to adults, infants and
children via treated lawns or recreational areas are likely if the
pesticide is used as labeled. However, the pesticide is a naturally
occurring microbe and is ubiquitous in the environment. Based on the
low toxicity potential as evidenced by the data submitted, the
microbial pesticide active ingredient is likely to pose a minimal to
non-existent dermal or inhalation hazard if used as labeled.

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IV. Cumulative Effects

    There is one other strain of Beauveria bassiana registered at this
time. While the two strains may produce similar metabolites, the
likelihood of adverse dietary effects via a common mechanism of
toxicity is likely to be minimal based on the lack of toxicity/
pathogenicity potential of the active ingredients.

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

    FFDCA section 408 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 pre- and post-natal toxicity
and the completeness of the database unless EPA determines that a
different margin of exposure (safety) will be safe for infants and
children. In this instance, EPA believes there are reliable data to
support the conclusion that there are no threshold effects of concern
to infants, children and adults when Beauveria bassiana (ATCC #74040)
is used as labeled. As a result, the provision requiring an additional
margin of exposure does not apply.
    There is a reasonable certainty that no harm will result from
aggregate exposure to the U.S. population, including infants and
children, to Beauveria bassiana (ATCC #74040) from the proposed uses.
This includes all anticipated dietary exposures and all other exposures
for which there is reliable information.

VI. Other Considerations

A. Endocrine Disruptors

    EPA does not have any information regarding endocrine effects of
this microbial pesticide at this time. The Agency is not requiring
information on the endocrine effects of this pesticide at this time;
and Congress allowed 3 years after August 3, 1996, for the Agency to
implement a screening and testing program with respect to endocrine
effects.

B. Analytical Method(s)

    The registrant has submitted data in support of the Agency
requirements to identify the active ingredient and potential
metabolites and 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 tolerances or exemption from tolerances for the
microbial active ingredient Beauveria bassiana ATCC #74040.

VII. Objections and Hearing Requests

    The new FFDCA 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)and as
was provided in the old section 408 and in section 409. However, the
period for filing objections is 60 days, rather than 30 days. EPA
currently has procedural regulations which governs the submission of
objections and hearing requests. These regulations will require some
modification to reflect the new law. However, until those modifications
can be made, EPA will continue to use those procedural regulations with
appropriate adjustments to reflect the new law.
    Any person may, by June 28, 1999, file written objections to any
aspect of this regulation and may also request a hearing on those
objections. Objections and hearing requests must be filed with the
Hearing Clerk, at the address given under the "ADDRESSES" section (40
CFR 178.20). A copy of the objections and/or hearing requests filed
with the hearing clerk should be submitted to the OPP docket for this
rulemaking. The objections submitted must specify the provisions of the
regulation deemed objectionable and the grounds for the objections (40
CFR 178.25). Each objection must be accompanied by the fee prescribed
by 40 CFR 180.33(i). 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 tolerance objection fee waivers,
contact James Tompkins, Registration Division (7505C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. Office location, telephone number, and e-mail
address: Rm. 239, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA, (703) 305-5697, tompkins.jim@epa.gov. Requests for
waiver of tolerance objection fees should be sent to James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460.
    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). 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). 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.

VIII. Public Record and Electronic Submissions

    EPA has established a record for this rulemaking under docket
control number [OPP-300821] (including any comments and data submitted
electronically). A public version of this record, including printed,
paper versions of electronic comments, which does not include any
information claimed as CBI, is available for inspection from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The public
record is located in Room 119 of the Public Information and Records
Integrity Branch, Information Resources and Services Division (7502C),
Office of Pesticide Programs, Environmental Protection Agency, Crystal
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202.
    Objections and hearing requests may be sent by e-mail directly to
EPA at:

    opp-docket@epa.gov.

    E-mailed objections and hearing requests must be submitted as an
ASCII file avoiding the use of special characters and any form of
encryption.
    The official record for this regulation, as well as the public
version, as described in this unit will be kept in paper form.
Accordingly, EPA will transfer any copies of objections and hearing
requests received electronically into printed, paper form as they are
received and will place the paper copies in the official record which
will also include all comments submitted directly in writing. The
official record is the paper record maintained at the Virginia

[[Page 22796]]

address in "ADDRESSES" at the beginning of this document.

IX. Regulatory Assessment Requirements

A. Certain Acts and Executive Orders

    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). 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) (Pub. L. 104-4). Nor does it require any
prior consultation as specified by Executive Order 12875, entitled
Enhancing the Intergovernmental Partnership (58 FR 58093, October 28,
1993), or 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 in accordance with Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997).
    In addition, 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. Nevertheless, 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 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.

B. Executive Order 12875

    Under Executive Order 12875, entitled Enhancing the
Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may
not issue a regulation that is not required by statute and that creates
a mandate upon a State, local or tribal government, unless the Federal
government provides the funds necessary to pay the direct compliance
costs incurred by those governments. If the mandate is unfunded, EPA
must provide to OMB a description of the extent of EPA's prior
consultation with representatives of affected State, local, and tribal
governments, the nature of their concerns, copies of any written
communications from the governments, and a statement supporting the
need to issue the regulation. In addition, Executive Order 12875
requires EPA to develop an effective process permitting elected
officials and other representatives of State, local, and tribal
governments "to provide meaningful and timely input in the development
of regulatory proposals containing significant unfunded mandates."
    Today's rule does not create an unfunded Federal mandate on State,
local, or tribal governments. The rule does not impose any enforceable
duties on these entities. Accordingly, the requirements of section 1(a)
of Executive Order 12875 do not apply to this rule.

C. Executive Order 13084

    Under Executive Order 13084, entitled Consultation and Coordination
with Indian Tribal Governments (63 FR 27655, May 19, 1998), EPA may not
issue a regulation that is not required by statute, that significantly
or uniquely affects the communities of Indian tribal governments, and
that imposes substantial direct compliance costs on those communities,
unless the Federal government provides the funds necessary to pay the
direct compliance costs incurred by the tribal governments. If the
mandate is unfunded, EPA must provide OMB, in a separately identified
section of the preamble to the rule, a description of the extent of
EPA's prior consultation with representatives of affected tribal
governments, a summary of the nature of their concerns, and a statement
supporting the need to issue the regulation. In addition, Executive
Order 13084 requires EPA to develop an effective process permitting
elected officials and other representatives of Indian tribal
governments "to provide meaningful and timely input in the development
of regulatory policies on matters that significantly or uniquely affect
their communities."
    Today's rule does not significantly or uniquely affect the
communities of Indian tribal governments. This action does not involve
or impose any requirements that affect Indian tribes. Accordingly, the
requirements of section 3(b) of Executive Order 13084 do not apply to
this rule.

X. 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 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 the rule in the Federal Register. This 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: April 12, 1999.
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 180.1205 is added to read as follows:

Sec. 180.1205  Beauveria bassiana ATCC #74040; exemption from the
requirements of a tolerance.

    An exemption from the requirement of a tolerance is established for
residues of the insecticide Beauveria bassiana (ATCC #74040) in or on
all food commodities when applied or used as ground and aerial foliar
sprays for use only on terrestrial crops.

[FR Doc. 99-10093 Filed 4-27-99; 8:45 am]
BILLING CODE 6560-50-F