Muscodor albus QST 20799 and the Volatiles Produced on Rehydration; Exemption from the Requirement of a Tolerance, 56569-56576 [05-19259]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 70, Number 187 (Wednesday, September 28, 2005)]
[Rules and Regulations]
[Pages 56569-56576]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-19259]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2005-0244; FRL-773-5]


Muscodor albus QST 20799 and the Volatiles Produced on 
Rehydration; 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 Muscodor albus (M. albus) QST 20799 
and the volatiles produced on its rehydration on all food commodities 
when applied or used for all agricultural applications, including seed, 
propagule and post harvest treatments. This action is in response to a 
pesticide petition submitted to EPA under the Federal Food, Drug, and 
Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 
1996 (FQPA), requesting an exemption from the requirement of a 
tolerance. This regulation eliminates the need to establish a maximum 
permissible level for residues of M. albus QST 20799 and the volatiles 
produced on its rehydration.

DATES: This regulation is effective September 28, 2005. Objections and 
requests for hearings must be received on or before November 28, 2005.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit IX. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under Docket 
identification (ID) number OPP-2005-0244. All documents in the docket 
are listed in the EDOCKET index at https://www.epa.gov/edocket. Although 
listed in the index, some information is not publicly available, i.e., 
CBI or other information whose disclosure is restricted by statute. 
Certain other material, such as copyrighted material, is not placed on 
the Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available either electronically 
in EDOCKET or in hard copy at the Public Information and Records 
Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 1801 S. 
Bell St., Arlington, VA. This docket facility is open from 8:30 a.m. to 
4 p.m., Monday through Friday, excluding legal holidays. The docket 
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Shanaz Bacchus, Biopesticides and 
Pollution Prevention Division (7511C), Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: 703-308-8097; e-mail address: bacchus.shanaz@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does This Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111);

[[Page 56570]]

     Animal production (NAICS code 112);
     Food manufacturing (NAICS code 311);
     Pesticide manufacturing (NAICS code 32532).
    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 this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Access Electronic Copies of this Document and Other 
Related Information?

    In addition to using EDOCKET (https://www.epa.gov/edocket/), you may 
access this Federal Register document electronically through the EPA 
Internet under the ``Federal Register'' listings at https://www.epa.gov/
fedrgstr/. A frequently updated electronic version of 40 CFR part 180 
is available at E-CFR Beta Site Two at https://www.gpoaccess.gov/ecfr/. 
To access the OPPTS Harmonized Guidelines referenced in this document, 
go directly to the guidelines at https://www.epa.gpo/opptsfrs/home/
guidelin.htm/.

II. Background and Statutory Findings

    In the Federal Register of April 7, 2004 (69 FR 18370-18375) (FRL-
734-4), EPA issued a notice pursuant to section 408(d)(3) of the FFDCA, 
21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance 
petition (PP 3F6745) by AgraQuest, Inc. (EPA Company No. 69592), 1530 
Drew Avenue, Davis, CA 95616. The petition requested that 40 CFR part 
180 be amended by establishing an exemption from the requirement of a 
tolerance for residues of M. albus QST 20799. This notice included a 
summary of the petition prepared by the petitioner AgraQuest, Inc. 
There were no comments received in response to the notice of filing.
    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 exemption is ``safe.'' Section 408(c)(2)(A)(ii) of the FFDCA 
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. Pursuant to section 408(c)(2)(B), in 
establishing or maintaining in effect an exemption from the requirement 
of a tolerance, EPA must take into account the factors set forth in 
section 408(b)(2)(C), which require 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) of the FFDCA 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.

III. Toxicological Profile

    Consistent with section 408(b)(2)(D) of the 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.
    M. albus QST 20799, a fungus, was originally isolated from the bark 
of a cinnamon tree in Honduras. It was imported into the United States 
with appropriate permits issued by the U.S. Department of Agriculture 
(USDA) Animal and Plant Health Inspection Services (APHIS). It grows as 
a white sterile mycelium and does not produce asexual or sexual spores 
or other reproductive structures such as chlamydospores or sclerotia. 
When hydrated, M. albus QST 20799 produces a number of volatiles, 
mainly alcohols, acids, and esters, that are claimed to inhibit and 
kill plant pathogenic organisms that cause diseases such as root rot, 
damping off, and wilt.
    The registrant is seeking to register a microbial pesticide in 
which the Manufacturing Use Product (MP) contains M. albus QST 20799 as 
the active ingredient. End-use Products (EPs) will be formulated from 
the MP by addition of inerts. The EPs, which will be registered 
concurrently with the MP, will be shipped as dried products. The EPs 
are proposed for use as a seed and propagule or soil treatment to 
control root diseases in greenhouse and field crops, as well as for 
control of post-harvest decay in fresh fruits and vegetables and cut 
flowers.
    1. Acute oral toxicity - rats (OPPTS 870.1100). Three female and 
three male rats were dosed with a single dose of M. albus QST 20799 in 
distilled water at 5 grams/kilogram body weight (g/kg bw). The rodents 
were observed for 14 days (Master Record Identification Number (MRID) 
46106401). No mortality was observed, all animals gained weight, and 
there were no clinical signs, or abnormal findings at necropsy. The 
oral LD50 for males, females, and combined was greater than 
5,000 milligram/kilogram (mg/kg) (Biopesticides and Pollution 
Prevention Division (BPPD) Data Evaluation Record (DER) dated April 28, 
2004, hereinafter referred to as ``BPPD DER 04/28/04'').
    M. albus QST 20799 produces volatiles when it is rehydrated. 
Generally, an acute oral test is not required when the test material is 
volatile. Nevertheless, the Agency considered the patterns of use, and 
the nature of the volatiles produced under these conditions. M. albus 
QST 20799 and its volatiles are not expected to be present in or on 
treated food commodities as a result of these proposed uses. The 
pesticide is incorporated into soil prior to planting, is not viable in 
soil once its food source is exhausted, and is not in direct contact 
with treated seed and propagule, or food or feed commodities treated 
post harvest. It is not a systemic pesticide and, thus, will not be 
translocated in seed and propagule, or other treated food and feed 
commodities. The volatiles are well-known fragrances and flavors of 
food and beverages, are short-lived, and are not expected to remain on 
treated food or feed commodities. Thus, acute oral tests, as conducted 
with the test material, M. albus QST 20799, are sufficient to evaluate 
in support of the petition of an exemption from tolerance.
    2. Acute oral toxicity/pathogenicity - rat study (Guideline 152-30; 
OPPTS 885.3050). Twenty-two male and 22 female rats were treated by 
oral gavage for 22 days with a white aqueous suspension of M. albus QST 
20799 (mean dry weight percentage: 1.82%) (MRID 46039404). Clinical 
signs were observed and body weights recorded

[[Page 56571]]

twice per day. The sacrificed rats were subjected to necropsy. No 
mortality was observed, all animals gained weight, and there were no 
clinical signs, or abnormal findings at necropsy. M. albus QST 20799 
was not detected in kidney, brain, liver, heart, lungs, spleen, 
mesenteric lymph nodes, blood samples, or intestinal contents. M. albus 
QST 20799 does not appear to be toxic, infective, and/or pathogenic to 
rats, when dosed at 108 cfu (0.1 g total dry weight)/animal. 
The study results were considered acceptable and the active ingredient 
is considered in Toxicity Category IV for acute oral effects (BPPD DER 
04/28/04).
    3. Acute pulmonary toxicity/pathogenicity - rat (OPPTS 885.3150). 
Twenty-nine female and 29 male rats received, by intratracheal 
instillation, a dose of 3 milliliters (ml) ( 1.9 x 103 to 
2.4 x 103 cfu) of an aqueous suspension of M. albus QST 
20799. They were observed for 22 days post treatment (MRID 46039406). 
However, two rats died early in the experiment likely due to the dosing 
procedure. Another rat was sacrificed at 4 days due to the severity of 
the clinical signs. Surviving rats were sacrificed, then subjected to 
necropsy. Recovery of viable test organism from blood, organs, 
intestinal contents, and feces was determined. No clinical signs 
related to the test organism or macroscopic abnormalities were noted in 
the rats. No test organisms were detected in any tissue sample tested. 
In general, M. albus QST 20799 does not appear to be toxic, infective, 
and/or pathogenic to rats at this dose. This study was considered 
acceptable (BPPD DER 04/28/04).
    4. Acute dermal toxicity - rabbits (Guideline 152-31; OPPTS 870-
2500/885-3100). To investigate dermal toxicity of M. albus QST 20799, 
five male and five female New Zealand white rabbits were treated with 
an aqueous suspension of M. albus QST 20799. The fur representing 
approximately 10% of the total body surface was clipped on the dorso-
lumbar region of each rabbit. The test substance (2 ml/kg equivalent to 
2 g/kg body weight) was applied on the skin site on each rabbit, then 
covered (MRID 46106402). After the dressings were removed in 
24 hours, the rabbits were observed at least twice daily for survival 
and were checked for clinical signs hourly post treatment and twice on 
subsequent days for 14 days. Body weight was recorded on days 1, 8, and 
15. The Draize method was utilized to rate skin irritation after test 
substance removal. The rabbits were euthanized and gross necropsied on 
day 15. No rabbits died and no clinical signs of toxicity were observed 
throughout the study. No dermal irritation was noted on any animal. One 
female lost weight during the first week and four males and one female 
lost weight during the second week. Overall, all animals gained weight. 
No treatment-related abnormal findings were noted. The test organism 
was not toxic to rabbits. The acute lethal dose (LD50) was 
greater than 2 mg/kg. The study is acceptable, and the pesticide is 
considered Toxicity Category IV for dermal effects (BPPD DER 04/28/04).
    5. Primary eye irritation (OPPTS Guideline 870.2400). Three female 
young adult New Zealand White rabbits were treated with M. albus QST 
20799. A solution of 0.1 ml/eye/animal was applied into the 
conjunctival sac of one eye, and the eye held closed for approximately 
1 second. The contralateral eye served as control. The eyes were 
examined and scored 1, 24, 48 and 72 hours after test material 
instillation (MRID 46039407). No corneal opacity, iritis, or positive 
conjunctival irritation was noted on any rabbit during the study. M. 
albus QST 20799 was practically non-irritating to the eyes of the 
rabbits. This study was considered acceptable and the pesticide placed 
in Toxicity Category IV for primary eye irritation (BPPD DER 04/28/04).
    6. Data waiver requests: MP and EP. Requests were made to waive 
data for the following requirements for the TGAI/MP and EP:
     Acute Inhalation (Guideline 152-32; OPPTS 870.1300);
     Acute Intravenous (IV), Intracerebral (IC), 
Intraperitoneal (IP) injection Toxicity/Pathogenicity (Guideline 152-
33; OPPTS 885.3200);
     Cell Culture (Guideline 152.39; OPPTS 885.3500);
     Immune Response (Guideline 152-38; OPPTS 885.3800);
     Hypersensitivity Study (Guideline 152-36);
     Hypersensitivity Incidents (Guideline 152-37; OPPTS 
870.3400).
    i. Acute inhalation toxicity/pathogenicity. The registrant cited 
the acute pulmonary toxicity/pathogenicity study (see Unit III.3, 
above) to justify waiving the acute inhalation study. In that study the 
active ingredient cleared tissues and was not toxic, infective, or 
pathogenic to rats when instilled intratracheally. In addition, the 
registrant's argument that the exposure during formulations of the 
granular EPs from the MP justifies granting this request to waive acute 
inhalation data requirements for the MP.
    However, the Agency did consider that exposure to all the volatiles 
produced during rehydration of the pesticide was not fully addressed. 
For product characterization and to establish that pesticide residues 
do not accumulate on treated commodities, the registrant provided data 
to the Agency about potential volatiles produced during rehydration of 
the active ingredient. These volatiles occur naturally in food 
products, and are used as fragrances, flavoring agents or as solvents. 
In submitted chromatograms, seven peaks (pks) were identified as pks 1, 
2, 3, 4, 6, 10 and 11, as discussed below (BPPD DER 06/ /05).
     (Pk 1) Ethyl propionate in wine, white grapes and, cocoa;
     (Pk 2) Isobutyl alcohol in food and beverages;
     (Pk 3) 2-Methylbutyl acetate in apples;
     (Pk 4) Isoamyl isobutyrate in honey, hop oil and whiskey;
     (Pk 6) 2-Methyl-1-butanol in wine, kiwi, apples and 
alcoholic beverages. It is a volatile component of blue cheese aroma, 
concord grape juice essence, nectarines, apples, papaya fruit, oranges, 
tomatoes and is released in the volatile emissions from poultry manure.
     (Pk 10) Isobutyric acid in cheese, fruits, vinegar and 
alcoholic beverages;
    (Pk 11) Phenethyl alcohol in foods such as olive oil, grapes, tea, 
apple juice, coffee, and alcoholic beverages (BPPD DER 06/ /05).
    At room temperature a 10 gram sample of the EP, Arabesque, 
rehydrated 1:1 with water, produced low concentrations of the volatiles 
ranging from 0.15 parts per billion (ppb) for 2-Methylbutyl acetate and 
Isoamyl isobutyrate to 20.5 ppb for Isobutyric acid. The inhalation 
LC50 was reported from published literature for most of the 
volatiles and found to be within acceptable threshold levels. Volatiles 
dissipating from the rehydrated pesticide are well below those reported 
inhalation LC50 values. All the volatiles are reported as 
naturally occurring in foods as fragrances and flavors, and they 
dissipate shortly after rehydration, without compromising efficacy in 
the time required for storage or other treatments related to proposed 
agricultural practices. However, the inhalation LC50 was not 
reported for Ethyl propionate, 2-Methylbutyl acetate, and Isoamyl 
isobutyrate. The Agency is of the opinion that the exposure to these 
substances may not pose a dietary risk via inhalation, because they are 
short-lived, well-characterized flavors and fragrances, which occur 
naturally in consumed food and feed commodities. This data requirement 
is satisfied for the purposes of the exemption from tolerance.

[[Page 56572]]

    ii. Acute IV/IP/IC study. In an acute oral toxicity/pathogenicity 
study (see Unit III.1 and 2 above) with the technical grade active 
ingredient (TGAI), no clinical signs of toxicity were observed in rats 
and no viable M. albus QST 20799 was recovered from blood, organs, or 
intestinal contents. Data from the registrant's in-house study show 
that M. albus is not viable at temperatures of 34 [deg]C and above, 
and, therefore, would not be expected to survive at mammalian body 
temperatures. Based on the low toxicity potential indicated by these 
observations, the request to waive the acute IP study was granted.
    iii. Cell culture. This study is required for a virus and is not 
required for a fungal active ingredient such as M. albus QST 20799. The 
request to waive this data requirement is granted.
    iv. Immune response. The lack of pathogenicity seen in the acute 
oral toxicity/pathogenicity study with the TGAI indicates the immune 
system was not adversely affected by M. albus QST 20799. Based on these 
considerations, the justifications to support the request to waive data 
requirements for the immune response studies for the TGAI/MP are 
acceptable.
    v. Hypersensitivity study. No incidents of hypersensitivity have 
occurred during the research, development, or testing of M. albus QST 
20799 or the ArabesqueTM end product. A hypersensitivity 
study is not required at this time, but may be required in the future 
if there are reports of hypersensitivity incidents associated with this 
active ingredient used in pesticides.
    vi. Hypersensitivity incidents (Guideline 152-37; OPPTS 870.3400). 
The registrant requested to waive reports of hypersensitivity 
incidents, because no incidents of hypersensitivity associated with the 
TGAI or proposed components of the EP have been reported to date. 
However, the registrant agreed to report hypersensitivity incidents, 
should they occur in the future. This guideline requirement is 
satisfied at this time. In order to comply with FIFRA requirements 
under Section 6(a)(2), any incident of hypersensitivity associated with 
the use of this pesticide must be reported to the Agency. This data 
requirement is not waived.
    7. Subchronic, chronic toxicity and oncogenicity, and residue data. 
Based on the data generated in accordance with the Tier I data 
requirements set forth in 40 CFR 158.740(c), the Tier II and Tier III 
data requirements were not triggered and, therefore, not required in 
connection with this action. In addition, because the Tier II and Tier 
III data requirements were not required, the residue data requirements 
set forth in 40 CFR 158.740(b) also were not required.

IV. Aggregate Exposures

    In examining aggregate exposure, section 408 of the FFDCA 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

    Use of M. albus QST 20799 and its EPs is not likely to cause any 
harm via consumption of food or feed treated with the microbe, which is 
not applied directly to food as discussed below.
    1. Food. Residues of M. albus QST 20799 and its volatiles are not 
expected on treated food commodities from the proposed use patterns. 
After pesticides containing M. albus QST 20799 are incorporated into 
soil prior to planting, the fungal active ingredient survives poorly in 
the soil once the food supply is depleted. Even though the fungal 
active ingredient itself, does not survive in soil, the volatiles 
produced by the microbe appear to control the target soil pests. Thus, 
neither the fungus nor its volatiles are in direct contact with, or 
expected to remain on, treated food commodities.
    Similarly, treatment using pesticides containing M. albus Strain 
QST 20799 after food is harvested (i.e., post harvest) does not involve 
contact with the treated commodities. Post-harvest treatment involves 
exposure of the food to the pesticide in warehouses or in shipping 
containers. Here, the rehydrated pesticides containing the fungal 
active ingredient are in sachets or containers, and are not in direct 
contact with the food or feed. During the period of treatment, 
volatiles released from the microbe inhibit the growth of organisms, 
which cause disease on food commodities, when they are being stored 
after harvest.
    Furthermore, the active ingredient is not a systemic pesticide. 
Thus, detectable residues of M. albus QST 20799, the microbe, are not 
expected on treated seed and propagules or food or feed commodities. 
The volatiles do occur naturally as flavors and fragrances in food and 
feed commodities. Hence, they are not expected to be present on treated 
seed and propagules, food or feed, solely as a result of treatment with 
this pesticide.
    As previously discussed in Unit III, data submitted to the Agency 
indicate that some of the volatiles produced by the fungus are Ethyl 
propionate, Isobutyl alcohol, 2-Methylbutyl acetate, Isoamyl 
isobutyrate, 2-Methyl-1-butanol, Isobutyric acid, Phenethyl alcohol. 
Many of these compounds are found in fruit aromas, fresh leaves, wine 
and rum aromas, blue cheese aroma, natural essential oils and olive and 
vegetable oil. Data submissions to the Agency indicate that residues of 
the volatiles do not appear to adhere to the treated commodities, nor 
leave any detectable residues on treated apples. Based on the nature of 
the volatiles, and their natural occurrence in some food commodities, 
they are not expected to be detectable residues solely as a result of 
treatment with M. albus QST 20799.
    From the above discussion it is clear that during any of the 
proposed uses, residues of the microbe or its volatiles are not 
expected on treated commodities. Normal washing, peeling, cooking, or 
processing of treated fruits and vegetables would further reduce any 
possible residues of M. albus QST 20799 or its volatiles. Finally, as 
discussed in Unit III, the acute oral tests demonstrate low toxicity 
potential via dietary exposure to this Toxicity Category IV pesticide. 
Hence, even if the pesticide was present in or on food commodities, 
exposure via the dietary route is not expected to cause any harm.
    Therefore, the Agency has decided that dietary exposure from the 
proposed uses of M. albus QST 20799 and its volatiles is not likely to 
adversely affect the U.S. adult population, infants and children.
    2. Drinking water exposure. Exposure to M. albus QST 20799 in 
drinking water is not likely to adversely affect U.S. adult population, 
infants and children, if the pesticide is used as labeled. The active 
ingredient belongs to the group referred to as ``mycelia sterilia'' 
which do not produce spores. This feature of the microbe allows for a 
short life cycle of M. albus QST 20799. Since M. albus Strain QST 20799 
occurs as a sterile mycelium and has no spores or resting structure, it 
is unlikely to be capable of substantial growth in soil after its food 
base in the product has been exhausted. Thus, transfer of M. albus 
Strain QST 20799 from soil to groundwater is unlikely. Even if such a 
transfer were to occur, the fungus would not tolerate the conditions 
drinking water treatment would provide, e.g., chlorination, pH 
adjustments, high temperatures, and/or processing conditions.
    The proposed uses of pesticides containing this active ingredient, 
suggest that neither the parent fungus, nor its volatiles are likely to 
persist or

[[Page 56573]]

accumulate in drinking water when the active ingredient is used as 
labeled. Potential risks via exposure to drinking water or runoff are 
adequately mitigated by, among other things, percolation through soil. 
Thus, exposure via drinking water from the proposed use of this active 
ingredient is not likely to adversely affect the U.S. population of 
adult humans, infants and children.

B. Other Non-Occupational Exposure

    Non-occupational dermal and inhalation exposure is unlikely, since 
the use sites are commercial and agricultural. Pesticide drift is 
expected to be minimal, since the EP is incorporated into the soil for 
pre-planting treatment, or is used in enclosed containers for post-
harvest treatment. Soil survivability of M. albus Strain QST 20799 is 
poor, and it has no spores or resting structure. The volatile compounds 
produced by M. albus Strain QST 20799 dissipate rapidly in the 
environment. The acute pulmonary toxicity study demonstrated no 
treatment-related adverse effects when the active ingredient was 
instilled into rats intratracheally. No hypersensitivity incidents have 
been reported for either the TGAI/MP or EPs.
    1. Dermal exposure. The low toxicity potential observed in the 
acute dermal studies discussed above (Unit III), the low exposure 
potential based on low application rates, and the lack of persistence 
of the active ingredient, leads EPA to conclude that this pesticide 
poses minimal risk to human populations via non-occupational dermal 
exposure. The volatiles produced by the active ingredient dissipate 
rapidly, and are thus not likely to adhere to, or penetrate, clothing, 
or adhere to the skin of the non-occupationally exposed population.
    Moreover, potential non-occupational dermal exposure to M. albus 
Strain QST 20799 is unlikely because the use sites are commercial and 
agricultural. The pesticide is granular in nature and the methods of 
application minimize pesticide drift. As previously discussed in Units 
III and IV, a lack of hypersensitivity incidents and the poor 
survivability of the fungus in soil indicate M. albus Strain QST 20799 
poses minimal risk to populations via non-occupational dermal exposure.
    Thus, the Agency does not expect pesticides containing M. albus QST 
20799 to pose a non-occupational dermal exposure hazard.
    2. Inhalation exposure. Non-occupational inhalation exposure to the 
active ingredient itself is not likely to cause an inhalation hazard. 
No treatment-related effects associated with the active ingredient were 
observed in the pulmonary tests reported above. The volatiles are 
produced on rehydration and are expected to dissipate during storage 
and shipment of treated commodities. They are also not likely to 
persist in the environment after application, as discussed above. 
Furthermore, these volatiles are known as fragrances or flavors 
associated with food. Based on the low potential for non-occupational 
inhalation exposure, the Agency does not expect these pesticides 
containing M. albus QST 20799 and its volatiles to pose an inhalation 
hazard.
    In summary, the potential aggregate exposure via treatment of soil, 
seed and propagules, fruits and vegetables, and cut flowers with M. 
albus Strain QST 20799 is not likely to pose a hazard via aggregate 
exposure. This includes hazards derived from (a) dietary exposure from 
the treated food/feed commodities, (b) drinking water potentially 
exposed secondary to treatment of sites with this pesticide; and (c) 
dermal and inhalation non-occupational and occupational exposure of 
populations exposed to M. albus Strain QST 20799.

V. Cumulative Effects

    Section 408(b)(2)(D)(v) of the FFDCA requires the Agency to 
consider the cumulative effect of exposure to M. albus QST 20799 and to 
other substances that have a common mechanism of toxicity. These 
considerations include the possible cumulative effects of such residues 
on infants and children. Based on tests in mammalian systems, M. albus 
QST 20799 and its volatiles do not appear to be toxic or pathogenic to 
humans. No other registered pesticide contains M. albus QST 20799 as an 
active ingredient. The pesticide is proposed to be used in a manner 
which will not directly contact treated food or feed commodities. It 
will not be translocated in seed and propagule because it is not 
systemic. One of the proposed uses, as a methyl bromide replacement, is 
a soil treatment.
    The volatiles, which are produced by the rehydrated fungus, appear 
to dissipate and are not absorbed by treated food commodities, thus 
leaving no detectable residues. The volatiles are also well-known 
components of fragrance and flavor associated with food, and are only 
produced for short periods when the fungus is rehydrated. Based on the 
low toxicity potential of M. albus QST 20799 and its volatiles (see 
Unit III above), and the low exposure scenario when the proposed 
pesticides are used as labeled, no cumulative or incremental effect is 
expected from its use.

VI. 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 M. albus QST 20799, 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 an 
antifungal agent on treated food commodities via dietary exposure since 
the organism is non-toxic and non-pathogenic to animals and humans. The 
Agency has arrived at this conclusion based on the very low levels of 
mammalian toxicity for acute oral, pulmonary, and dermal effects with 
no toxicity or infectivity at the doses tested (see Unit III. above). 
Moreover, potential non-occupational inhalation or dermal exposure is 
not expected to pose any adverse effects to exposed populations via 
aggregate and cumulative exposure (see Units IV. and V.)
    FFDCA section 408(b)(2)(C) 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 on toxicity 
and exposure, unless EPA determines that a different margin of exposure 
(safety) will be safe for infants and children. Margins of exposure 
(safety), which are often referred to as uncertainty factors, are 
incorporated into EPA risk assessment either directly, or through the 
use of a margin of exposure analysis, or by using uncertainty (safety) 
factors in calculating a dose level that poses no appreciable risk. In 
this instance, based on all the available information (as discussed in 
detail above), the Agency concludes that the fungus, M. albus QST 
20799, is non-toxic to mammals, including infants and children. Because 
there are no threshold effects of concern to infants, children and 
adults when M. albus QST 20799 is used as labeled, the Agency has 
determined that the additional margin of safety is not necessary to 
protect infants and children, and that not adding any additional margin 
of safety will be safe for infants and children. As a result, EPA has 
not used a margin of exposure (safety) approach to assess the safety of 
M. albus QST 20799.

[[Page 56574]]

VII. Other Considerations

A. Endocrine Disruptors

    EPA is required under section 408(p) of the FFDCA, as amended by 
FQPA, to develop a screening program to determine whether certain 
substances (including all pesticide active and other ingredients) ``may 
have an effect in humans that is similar to an effect produced by a 
naturally-occurring estrogen, or other such endocrine effects as the 
Administrator may designate.'' Following the recommendations of its 
Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC), 
EPA determined that there was scientific basis for including, as part 
of the program, the androgen and thyroid systems, in addition to the 
estrogen hormone system. EPA also adopted EDSTAC's recommendation that 
the program include evaluations of potential effects in wildlife. For 
pesticide chemicals, EPA will use FIFRA and, to the extent that effects 
in wildlife may help determine whether a substance may have an effect 
in humans, FFDCA authority, to require the wildlife evaluations. As the 
science develops and resources allow, screening of additional hormone 
systems may be added to the Endocrine Disruptor Screening Program 
(EDSP).
    At this time, the Agency is not requiring information on the 
endocrine effects of this active ingredient, M. albus QST 20799. The 
Agency has considered, among other relevant factors, available 
information concerning whether the microorganism may have an effect in 
humans similar to an effect produced by a naturally occurring estrogen 
or other endocrine effects. There is no known metabolite that acts as 
an ``endocrine disruptor'' produced by this microorganism. The 
submitted toxicity/infectivity or pathogenicity studies in the rodent 
(required for microbial pesticides) indicate that, following oral, 
pulmonary and dermal routes of exposure, the immune system is still 
intact and able to process and clear the active ingredient (see Unit 
III.). In addition, based on the low potential exposure level 
associated with the proposed labeled uses of the pesticide, the Agency 
expects no adverse effects to the endocrine or immune systems. Thus, 
there is no impact via endocrine-related effects on the Agency's safety 
finding set forth in this Final Rule for M. albus QST 20799.

B. Analytical Method(s)

    The acute oral studies discussed above demonstrate that neither the 
active ingredient nor the volatiles produced by the rehydrated fungus 
pose a dietary risk. In addition, the active ingredient is not likely 
to come into contact with the treated food commodities. The volatiles 
from the rehydrated fungal active ingredient dissipate quickly. They do 
not appear to leave any detectable residues on treated food 
commodities, when used as labeled. Furthermore, the low application 
rate and non-persistence on food during soil applications suggests very 
low exposure potential via the dietary route. Since residues are not 
expected on treated commodities, the Agency has concluded that an 
analytical method to detect residues of this pesticide on treated food 
commodities for enforcement purposes is not needed.
    Nevertheless, the Agency has concluded that for analysis of the 
pesticide itself, microbiological and biochemical methods exist and are 
acceptable for enforcement purposes for product identity of M. albus 
QST 20799, and the volatiles produced by the rehydrated fungus. Other 
appropriate methods are required for quality control to assure that 
product characterization, the control of human pathogens and other 
unintentional metabolites or ingredients are within regulatory limits, 
and to ascertain storage stability and viability of the pesticidal 
active ingredient.

C. Codex Maximum Residue Level

    There is no Codex maximum residue level for residues of M. albus 
QST 20799.

VIII. Conclusions

    The results of the studies discussed above are sufficient to comply 
with the requirements of the FQPA. They support an exemption from the 
requirement of a tolerance for residues of M. albus QST 20799, on 
treated food or feed commodities. In addition, the Agency is of the 
opinion that, if the microbial active ingredient is used as labeled, 
aggregate and cumulative exposures are not likely to pose any undue 
hazard. The volatiles produced when the fungus is rehydrated also do 
not pose an incremental dietary and non-dietary risk to the adult human 
U.S. population, children and infants. Therefore, an exemption from 
tolerance is granted in response to pesticide petition 3F6745.

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, EPA will continue to use those procedures, with 
appropriate adjustments, until the necessary modifications can be made. 
The new section 408(g) of the FFDCA 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) 
of the FFDCA, as was provided in the old sections 408 and 409 of the 
FFDCA. 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 ID number OPP-2005-0244 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 November 
28, 2005.
    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 (1900L), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Suite 350, 1099 14th St., 
NW., Washington, DC 20005. 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) 564-6255.

[[Page 56575]]

    2. 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 ADDRESSES. Mail your 
copies, identified by docket ID number OPP-2005-0244, to: Public 
Information and Records Integrity Branch, Information Technology and 
Resource Management Division (7502C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. In person or by courier, bring a copy to the 
location of the PIRIB described in ADDRESSES. 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. Statutory and Executive Order Reviews

    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). Because this rule has been exempted from review under Executive 
Order 12866 due to its lack of significance, this rule is not subject 
to Executive Order 13211, Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 
May 22, 2001). 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 section 408(d) of the FFDCA, such as the tolerance 
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. The Agency hereby certifies that this 
rule will not have significant negative economic impact on a 
substantial number of small entities. 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 section 408(n)(4) of the 
FFDCA. 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. Congressional Review Act

    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: September 20, 2005.
James Jones,
Director, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

[[Page 56576]]

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

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

0
2. Section 180.1260 is added to subpart D to read as follows:


Sec.  180.1260  Muscodor albus QST 20799 and the volatiles produced on 
rehydration; exemption from the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established on 
all food/feed commodities, for residues of Muscodor albus QST 20799, 
and the volatiles produced on its rehydration, when the pesticide is 
used for all agricultural applications, including seed, propagule and 
post harvest treatments.

[FR Doc. 05-19259 Filed 9-27-05; 8:45 am]
BILLING CODE 6560-50-S