Document ID: EPA-HQ-OPP-2010-0087-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2010-03-10T05:00Z

EPA BIOPESTICIDES AND POLLUTION PREVENTION DIVISION

NOTICE OF FILING TEMPLATE FOR PESTICIDE PETITIONS PUBLISHED IN THE

FEDERAL REGISTER 

EPA Biopesticides and Pollution Prevention Division contact: Shanaz
Bacchus (703) 308-8097 

EPA has received a pesticide petition [insert petition number] from
Certis USA LLC, 9145 Guilford Road, Suite 175, Columbia, MD 21046
proposing pursuant to section 408(d) of the Federal Food, Drug, and
Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 to
establish an exemption from the requirement of a tolerance for residues
of the microbial pesticide Paecilomyces fumosoroseus Apopka strain 97 in
or on all agricultural commodities. 

Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended, Certis USA
LLC has submitted the following summary of information, data, and
arguments in support of their pesticide petition. This summary was
prepared by Certis USA LLC and EPA has not fully evaluated the merits of
the pesticide petition. The summary may have been edited by EPA if the
terminology used was unclear, the summary contained extraneous material,
or the summary unintentionally made the reader conclude that the
findings reflected EPA’s position and not the position of the
petitioner. 

I. Certis USA LLC Petition Summary 

PP 9F7665 

A. Product name and Proposed Use Practices 

The microbial pest control agent is Paecilomyces fumosoroseus.Apopka
strain 97. Paecilomyces fumosoroseus Apopka strain 97 belongs to the
class of Fungi imperfecti.  It was isolated on a large number of insects
throughout the world. The insecticidal activity is related to the
ability of the blastospores to infect a host insect. The spores form
appressoria and penetrate into the insect cuticle. The fungus continues
to grow within the insect which finally leads to the disruption of the
host. In high moisture conditions, conidia and conidiophores are
produced after the death of the insect.

The species Paecilomyces fumosoroseus Apopka strain 97 has wide range of
insect hosts. The proposed use by Certis USA is for application to
growing crops and ornamental plants for control of aphids, mites and
whiteflies.

B. Product Identity/Chemistry 

Identity of the pesticide and corresponding residues. 

The microbial pest control agent Paecilomyces fumosoroseus Apopka strain
97 is a naturally occurring soil fungus which is entomopathogenic to
many orders of insects. It will infect and control several insect pests
including whiteflies, thrips, aphids and spider mites.  Under proper
environmental conditions spores of the fungus attach to and penetrate
the cuticle of the insect.  The fungus grows inside the insect causing
its death.

Paecilomyces fumosoroseus Apopka stain 97 has been reported to be
originally isolated in 1986 from a mealy bug in a greenhouse in Apopka,
FL. The pure culture was identified in 1988 and deposited at the
American Type Culture Collection (ATCC # 20874). Paecilomyces species
occur naturally in populations of infected and dead insects and randomly
in soils around the world. The active ingredient can be cultured readily
on various culture media and exists in several morphological stages,
depending upon the culture medium. On solid medium, conidiophores,
conidia and mycelia are predominant while submerged culture produces
blastospores and mycelia.

Magnitude of residue at the time of harvest and method used to determine
the residue. 

Paecilomyces fumosoroseus Apopka strain 97 is a naturally occurring
fungus which has been isolated in soils worldwide and as such, humans,
animals, and plants are constantly exposed to this fungus.  It is
expected that, when used as proposed, Paecilomyces fumosoroseus Apopka
strain 97 would not result in residues that are of toxicological
concern.   

Paecilomyces fumosoroseus Apopka strain 97 is affected by sunlight,
temperature, humidity, substrate, and chemicals, which reduces the
potential for residues to occur. Normal washing after harvest and before
sale would further reduce or remove any residues.  Additionally, there
is a low probability of germination in the absence of an insect host on
harvested crops, further reducing the chance of residues on treated
crops.

Any potentially occurring residual deposits on crops will not harm
humans because the strain shows no toxicity, infectivity, or
pathogenicity in appropriate tests.  Further the optimal temperature
range for growth, germination and sporulation is between 20 and 30
degrees C while the normal body temperatures of humans, other mammalian
species and avian species is significantly higher than 30 degrees C and
therefore unsuitable for growth and reproduction of Paecilomyces
fumosoroseus Apopka strain 97.

The active substance is produced in liquid fermentation. Secondary
metabolites such as

beauverolides and beauvericine have been detected in still culture, but
not in liquid

fermentation. 

3. A statement of why an analytical method for detecting and measuring
the levels of the pesticide residue are not needed. 

The acute toxicity and genotoxicity studies discussed in Section C of
this document are sufficient to show that there are no foreseeable human
or domestic health hazards likely to arise from the use of the product
as proposed. This fungus occurs naturally and is present on foods
regardless of treatment. Since enforcement of residue levels would not
be needed, an enforcement analytical method is not required. Certis USA
is requesting an exemption from the requirement for a tolerance for any
residues remaining in/on all agricultural commodities. 

 C. Mammalian Toxicological Profile 

Acute oral toxicity/pathogenicity- rat – In an acute test with rats,
oral application of 1.7x106 colony forming units per animal in form of a
conidia spore suspension did neither cause mortality nor abnormal
clinical effects. No signs of fungal contamination of brain, mesenteric
lymph nodes, blood, kidney, spleen, liver, lung or caecum or infectivity
or pathogenicity were recorded.

Acute intraperitoneal toxicity/pathogenicity – rat – the test
substance was administered to 18 male and 18 female rats.  No signs of
toxicity or pathogenicity were observed under the condition of the test.
 Single intraperitoneal doses of suspensions containing 1.6x107 conidia
spores per animal had no toxic or pathogenic effects in rats and the
spores were cleared from the body within two days. EPA has classified
the product as toxicity category IV.

Acute pulmonary toxicity/pathogenicity- rat – in this test a single
intratracheal dose was administered to test animals.  No deaths occurred
and there were no signs of toxicity observed in any animal under the
conditions of this test.  No signs of infection were seen and no
colonization of the lungs was observed. Total clearance of the fungus
was attained by day eight after treatment. EPA has classified the
product as toxicity category IV.

Acute dermal toxicity/pathogenicity- rat – in this test 2 grams of
test substance was applied to the skin of rabbits.  No deaths occurred
and there was no evidence of systemic toxicity under the conditions of
this test.  EPA has classified the product as toxicity category III.

Primary eye irritation  – the test substance was instilled in the eye
of albino rabbits and examined at 1, 24, 48 and 72 hours and at 4 and 7
days after treatment.  The test substance produced slight irritation
which was reversible by day 4 after treatment.   Based on the test
results EPA has classified the product as toxicity category IV.

Dermal irritation – rabbit  – in a four hour dermal exposure to the
skin of rabbits, the test substance was found to be a slight dermal
irritant and EPA has classified the product as toxicity category IV.

Dermal sensitization – guinea pig  – the test substance was
administered dermally to guinea pigs.  The test substance produced no
irritation or sensitization reaction in treated animals.  EPA has
classified the product as ‘not a dermal sensitizer’.

Mutagenicity Test on Salmonella Typhimurium (Ames Assay) – Sonicated
blastospores and mycelium of Paecilomyces fumosoroseus Apopka strain 97
yielded negative results in a Salmonella microsome reverse mutation
assay in both the presence and absence of microsomal enzymes (S9).

D. Aggregate Exposure 

1. Dietary exposure.   

Food

Paecilomyces fumosoroseus Apopka strain 97 is a naturally occurring
fungus which has been isolated in soils worldwide and as such, humans,
animals, and plants are constantly exposed to this fungus.  It is
expected that, when used as proposed, Paecilomyces fumosoroseus Apopka
strain 97 would not result in residues that are of toxicological
concern.  Paecilomyces fumosoroseus Apopka strain 97 is affected by
sunlight, temperature, humidity, substrate, and chemicals.  As a
pesticide it germinates and grows on insect hosts, but cannot grow on
the treated crops per se.  When exposed to sunlight, Paecilomyces
fumosoroseus Apopka strain 97  lose their viability rapidly with
half-lives that may be as short as 2-3 hours.

After harvest any remaining fungal spores on crops will be exposed to
unfavorable conditions (e.g. dryness), and are not likely to germinate
and grow on the harvested crop. Any potentially occurring residual
deposits on these crops will not harm humans because the strain shows no
toxicity, infectivity, or pathogenicity in appropriate tests.  Further
the optimal temperature range for growth, germination and sporulation is
between 20 and 30 degrees C while the normal body temperatures of
humans, other mammalian species and avian species is significantly
higher than 30 degrees C and therefore unsuitable for growth and
reproduction of Paecilomyces fumosoroseus Apopka strain 97.

While the proposed use pattern may result in dietary exposure with
possible residues in or on certain agricultural commodities, negligible,
to no risk, is expected for the general population, including infants
and children, or animals because Paecilomyces fumosoroseus Apopka strain
97 demonstrated no pathogenicity or toxicity at the maximum doses
tested.

Since Paecilomyces fumosoroseus Apopka strain 97 is a fungus that is
naturally occurring in insects and in soils, humans may be exposed
dermally and orally to this common fungus when they get soil on their
hands or clothing, or handle pets that have played in soil. Importantly,
no toxicological endpoints were identified for Paecilomyces fumosoroseus
Apopka strain 97 and there is no evidence of adverse effects from oral,
dermal, or pulmonary exposure to this MPCA.  It is not expected that the
pesticidal use of Paecilomyces fumosoroseus Apopka strain 97 will
significantly increase the non-dietary and non-occupational exposure to
the fungus. 

   

Based on the proposed use patterns, in which Paecilomyces fumosoroseus
Apopka strain 97 is applied directly to soil of agricultural and
ornamental crops, the potential for non-dietary, non-occupational
exposures to Paecilomyces fumosoroseus Apopka strain 97 pesticide
residues by the general population, including infants and children, is
low. Moreover, even in the unlikely event of non-dietary,
non-occupational exposures to Paecilomyces fumosoroseus Apopka strain 97
pesticide residues, no harm is expected because no toxicity or
pathogenicity was found in mammalian studies that included high levels
of oral, pulmonary, and dermal exposure.

. Drinking water. 

Paecilomyces fumosoroseus Apopka strain 97 is not known as an aquatic
microorganism, and therefore is not expected to proliferate in aquatic
habitats. There are no aquatic use sites permitted for this pesticide,
so exposure to drinking water is not expected. Both percolation through
soil and municipal treatment of drinking water would reduce the
possibility of exposure to Paecilomyces fumosoroseus Apopka strain 97
through drinking water. Accordingly, the use of this MCPA on terrestrial
plants is not anticipated to lower the quality of drinking water. Even
if low levels of the microbe were present in drinking water, no risk to
the general public would be expected because Paecilomyces fumosoroseus
Apopka strain 97 demonstrated no pathogenicity or toxicity at the
maximum dose tested. The potential of significant transfer to drinking
water is minimal to nonexistent. 

2. Non-dietary exposure.

Since Paecilomyces fumosoroseus Apopka strain 97 is naturally a
occurring fungus, there may be non-dietary exposure from these naturally
occurring background levels.   However, it is not expected that the
pesticidal use of Paecilomyces fumosoroseus Apopka strain 97 will
significantly increase the non-dietary and non-occupational exposure to
the fungus.

E. Cumulative Exposure 

There is reasonable certainty that no harm will result to the U.S.
population, including infants and children, from aggregate exposures to
residues of Paecilomyces fumosoroseus Apopka strain 97  as a result of
its proposed uses. This includes all anticipated dietary exposures and
all other exposures for which there is reliable information. There
appears to be no potential for harm, from this fungus in its use as a
microbial pesticide in agricultural commodities. Furthermore, the
organism is naturally occurring in soils, and is non-toxic and
non-pathogenic to animals and humans. This conclusion is based on the
results of the mammalian toxicity tests referenced in Section C.
Moreover, potential non-occupational inhalation or dermal exposure is
not expected to pose any adverse effects to exposed populations via
aggregate and cumulative exposure. 

Therefore no cumulative effects from the residues of this product with
other related microbial pesticides are anticipated. 

F. Determination of Safety for U.S. population, Infants and Children 

There is reasonable certainty that no harm will result to the U.S.
population, including infants and children, from aggregate exposures to
residues of Paecilomyces fumosoroseus Apopka strain 97 as a result of
its proposed uses.  This includes all anticipated dietary exposures and
all other exposures for which there is reliable information.  As
discussed previously, there appears to be no potential for harm, from
this fungus in its use as a microbial pesticide in production of growing
crops or in production of ornamental plants.  Furthermore, the organism
is naturally occurring in the environment, and non-toxic and
non-pathogenic to animals and humans.  This conclusion is based on the
results of the mammalian toxicity tests discussed in Section C. 
Moreover, potential non-occupational inhalation or dermal exposure is
not expected to pose any adverse effects to exposed populations via
aggregate and cumulative exposure.

G. Effects on the Immune and Endocrine Systems 

There is no information to indicate that Paecilomyces fumosoroseus
Apopka strain 97 would have an effect in humans similar to an effect
produced by a naturally-occurring estrogen or other endocrine effects. 
There is no known metabolite produced by this yeast that acts as an
endocrine disruptor.  The submitted toxicity/pathogenicity studies in
rodents indicate that following dosing that no viable conidia or
blastospores were found in organs or tissues of test animals.  It is
concluded that there will be no incremental adverse effects to the
endocrine system.

H. Existing Tolerances 

There are no existing tolerances or tolerance exemptions for
Paecilomyces fumosoroseus Apopka strain 97.

 EPA has established an exemption from the requirement of a tolerance
for residues of the fungus Paecilomyces lilacinus in or on all
agricultural commodities at 40 CFR Part 180.1257. 

I. International Tolerances 

The European Food Safety Authority Scientific Report (2007), 115, 1-161,
determined that under Regulation (EC) No 396/2005 of the European
Parliament and of the Council on Maximum

Residue Levels for pesticides (28 October 2007) that no MRLs and no
residue definitions have

to be established for the use of Paecilomyces fumosoroseus Apopka strain
97 on agricultural crops.

EPA-HQ-OPP-2010-0087 		Paecilomyces fumosoroseus Apopka strain 97

Company notice of filing of pesticide petition requesting tolerance
exemption