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Metarhizium anisopliae Strain ESF1 - Exemption of Tolerance Requirement 5/93

40 CFR Parts 180, 185, 186
[PP 2F4076 & FAP 2H5626/R1185; FRL-4577-1]
RIN 2070-AB78
Food and Feed Additive Regulations and Exemption From the Requirement
of a Pesticide Tolerance for the Microbial Pest Control Agent
Metarhizium Anisopliae Strain ESF1
AGENCY: Environmental Protection Agency (EPA)
ACTION: Final rule.
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SUMMARY: EPA is establishing food and feed additive regulations
as well as an exemption from the requirement of a pesticide
tolerance on all raw agricultural commodities regarding the
use of the microbial pest control agent Metarhizium anisopliae
strain ESF1 in food-handling establishments, feed-handling establishments,
and greenhouses in accordance with certain prescribed conditions.
EcoScience Corp. requested this regulation.

EFFECTIVE DATE: This regulation becomes effective on May 19,
1993.

ADDRESSES: Written objections, identified by the document control
number [PP 2F4076 & FAP 2H5626/R1185], may be submitted to the:
Hearing Clerk (A-110), Environmental Protection Agency, rm.
3708M, 401 M St., SW., Washington, DC 20460.

FOR FURTHER INFORMATION CONTACT: Philip O. Hutton, Product Manager
(PM) 18, Registration Division (H7505C), Office of Pesticide
Programs, Environmental Protection Agency, rm. 213, CM .2, 1921
Jefferson Davis Hwy., Arlington, VA 22202, (703)-305-7690.

SUPPLEMENTARY INFORMATION: In the Federal Register of June 10,
1992 (57 FR 24645, 24656), EPA issued notices announcing that
EcoScience of Worcester, MA, had submitted a pesticide petition
(PP 2F4076) and a food/feed additive petition (FAP 2H5626) to
EPA proposing that 40 CFR part 180 be amended by establishing
a regulation for permanent exemption from the requirement of
a tolerance for Metarhizium anisopliae in or on all raw agricultural
commodities and that 40 CFR parts 185 and 186 be amended by
exempting Metarhizium anisopliae, when used to control cockroaches,
from the requirement of a tolerance in or on processed food
and animal feed.
   On July 23, 1992, EcoScience amended both petitions to limit
the uses covered by the proposed exemption from the requirement
of a tolerance and food and feed additive regulation to traps
and bait stations. In publishing these food and feed additive
regulations and tolerance exemption, EPA chose to use the broader
term "attractant stations" in place of the terms "traps and
bait stations." This was done because risk concerns remain
the same and the term "attractant stations" includes traps
and bait stations as well as other products that attract target
pest(s) to stations containing the active ingredient. EPA chose
to limit the applicability of these regulations to Metarhizium
anisopliae strain ESF1 because different strains of Metarhizium
anisopliae may have differing results in toxicity/pathogenicity
studies.
   There were no comments or requests for referral to an advisory
committee received in response to the notice of filing. The
scientific data submitted in the petitions and other relevant
material have been evaluated.
   The toxicological data considered in support of the exemption
from the requirement of a tolerance and food and feed additive
regulations include an acute oral toxicity/pathogenicity study
in the rat, an acute pulmonary toxicity/pathogenicity study
in the rat, an acute intravenous toxicity/pathogenicity in the
rat, a dermal toxicity study in the rabbit, and a primary eye
irritation study in the rabbit, as well as data indicating that
Metarhizium anisopliae is unable to grow at or above 95 degrees F.
   The results of the toxicity/pathogenicity studies show no
toxic, pathogenic, or adverse effects. These studies demonstrated
that rodents can effectively clear the fungus from their bodies
even after it is injected at high amounts. The results of the
temperature growth study show that Metarhizium anisopliae cannot
grow at mammalian body temperatures and should not be able to
grow in the organs or tissues of humans. No toxicity or irritation
was observed in the dermal study, and only grade-one erythema
and edema were present in most animals at the 1- and 24-hour
evaluation periods in the 7-day primary eye irritation study.
   Certain strains of Metarhizium anisopliae produce a class
of mycotoxins called destruxins (insecticidal cyclodepsipeptides).
There are no known reports of destruxins causing adverse mammalian
health effects; however, other mycotoxins are known to adversely
affect human health. As stated earlier, no toxic, pathogenic,
or toxic adverse effects were observed in any of the submitted
studies. Based on these studies, the Agency believes that the
form of Metarhizium anisopliae strain ESF1 that was tested and
is to be sold in commerce did not contain destruxins, or it
posed no significant adverse effects to human health if destruxins
were present. EPA makes this conclusion from the assumption
that mycotoxins that may adversely affect human health would
show acute adverse effects in toxicity/pathogenicity studies.
Since different environmental conditions may affect destruxin
production, lack of acute effects in mammalian toxicity/pathogenicity
studies alone could not preclude the potential for destruxin
production in the target insects. However, since the LT50s (time
required to kill 50 percent of the population) for strain ESF1
in the German cockroach and the house fly are 10 days and greater
than 6 days, respectively, there is little or no chance that
insects infected with strain ESF1 from the attractant stations
would contain destruxins. Destruxin-producing strains of Metarhizium
anisopliae tend to cause faster insect mortality due to destruxin
toxicity. The mode of action for strains not producing destruxins
appears to be primarily from proliferation of the fungus and
subsequent death of the infected insect.
   In the unlikely event that insects exposed to strain ESF1
in attractant stations contain destruxins, and such insects
before death contaminate foods or feeds processed or stored
in a food- or feed-handling establishment, such foods may be
considered adulterated under provisions of 21 U.S.C. 342(a)(3)
and be subject to regulatory sanctions by the Food and Drug
Administration (FDA). To avoid potential FDA enforcement action,
all food-handling facilities using pesticides, including those
that use Metarhizium anisopliae strain ESF1 for insect control,
should make every effort to protect foods and feeds from contamination
with insects or insect fragments.
   Reference Dose (RfD) and maximum permissible intake (MPI)
considerations are not relevant to this petition because the
data submitted demonstrate that this biological control agent
is not toxic to humans. Because no tolerance level is set for
this microbial pest control agent, the requirement for an analytical
method for enforcement purposes is not applicable to these food
additive regulations and exemption from the requirement of a
tolerance.
   Based on the information cited above, the Agency has determined
that the use of Metarhizium anisopliae under the conditions
of this regulation will be safe and will protect the public
health. The pesticide is considered useful for the purpose for
which the tolerance exemption and food and feed additive regulations
are sought and capable of achieving the intended physical or
technical effect. Therefore, the tolerance and food and feed
additive regulations are established as set forth below.
   Any person adversely affected by this regulation may, within
30 days after the date of publication of this document in the
Federal Register, file written objections and/or a request for
a hearing with the Hearing Clerk at the address given above.
40 CFR 178.20. 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). If a hearing is requested,
the objections must include a statement of the factual issue(s)
on which a hearing is requested, the requestor's contentions
on each such issue, 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 issue(s) in the manner sought
by the requestor would be adequate to justify the action requested.
40 CFR 178.32.
   The Office of Management and Budget has exempted this rule
from the requirements of section 3 of Executive Order 12291.
Pursuant to the requirements of the Regulatory Flexibility Act
(Pub. L. 96-354, 94 Stat. 1164, 5 U.S.C. 601-612), the Administrator
has determined that regulations establishing new tolerances
or food additive regulations or raising tolerance levels or
food additive regulations or establishing exemptions from tolerance
requirements do not have a significant economic impact on a
substantial number of small entities. A certification statement
to this effect was published in the Federal Register of May
4, 1981 (46 FR 24950).

List of Subjects in 40 CFR Parts 180, 185, and 186

   Administrative practice and procedure, Agricultural commodities,
Food additives, Feed additives, Pesticides and pests, Reporting
and recordkeeping requirements.

Dated: May 7, 1993.

Douglas D. Campt,
Director, Office of Pesticide Programs.
   Therefore, 40 CFR parts 180, 185, and 186 are amended as
follows:

PART 180-[AMENDED]

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

   Authority: 21 U.S.C. 346a and 371.

   b. By adding new . 180.1116, to read as follows:

. 180.1116  Metarhizium anisopliae strain ESF1; exemption from
the requirement of a tolerance.

   An exemption from the requirement of a tolerance is established
for the microbial pest control agent Metarhizium anisopliae
strain ESF1 on all raw agricultural commodities in accordance
with the following prescribed conditions:
   (a) Application shall be limited solely to placement of attractant
stations containing Metarhizium anisopliae strain ESF1.
   (b) To ensure safe use of the microbial pest control agent,
its label and labeling shall conform to that registered by the
U.S. Environmental Protection Agency.

PART 185-[AMENDED]

   2. In part 185:
   a. The authority citation for part 185 continues to read
as follows:

   Authority: 21 U.S.C. 348.

   b. By adding new . 185.4035, to read as follows:

. 185.4035   Metarhizium anisopliae strain ESF1.

   A food additive regulation is established allowing the use
of the microbial pest-control agent Metarhizium anisopliae strain
ESF1 as follows:
   (a) Metarhizium anisopliae strain ESF1 may be present as
a residue in food items as a result of application of Metarhizium
anisopliae strain ESF1 in food-handling establishments, including
food service, manufacturing, and processing establishments such
as restaurants, cafeterias, supermarkets, bakeries, breweries,
dairies, meat-slaughtering and packing plants, and canneries
where food and food products are held, processed, and served.
   (b) Application shall be limited solely to placement of attractant
stations containing Metarhizium anisopliae strain ESF1 in food-
handling establishments.
   (c) To ensure safe use of the microbial pest control agent,
its label and labeling shall conform to that registered by the
U.S. Environmental Protection Agency, and it shall be used in
accordance with such label and labeling.

PART 186-[AMENDED]

   3. In part 186:
   a. The authority citation for part 186 continues to read
as follows:

   Authority: 21 U.S.C. 348.

   b. By adding new . 186.4035, to read as follows:

. 186.4035   Metarhizium anisopliae strain ESF1.

   A feed additive regulation is established allowing the use
of the microbial pest-control agent Metarhizium anisopliae strain
ESF1 as follows:
   (a) Metarhizium anisopliae strain ESF1 may be present as
a residue in or on processed animal feeds as a result of application
of Metarhizium anisopliae strain ESF1 in feed-handling establishments,
including areas where livestock and poultry feed is consumed,
feed-manufacturing establishments and feed-processing establishments
such as stores, supermarkets, dairies, poultry houses, livestock
barns, meat-slaughtering and packing plants, and canneries,
where feed and feed products are held, processed, sold and/or
consumed by livestock or poultry.
   (b) Application shall be limited solely to placement of attractant
stations containing Metarhizium anisopliae strain ESF1 in animal
feed- handling establishments.
   (c) To ensure safe use of the microbial pest control agent,
its label and labeling shall conform to that registered by the
U.S. Environmental Protection Agency, and it shall be used in
accordance with such label and labeling.

[FR Doc. 93-11870 Filed 5-18-93; 8:45 am]