[Federal Register: September 28, 2005 (Volume 70, Number 187)]
[Rules and Regulations]
[Page 56569-56576]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28se05-5]
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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 http://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 (http://www.epa.gov/edocket/), you may
access this Federal Register document electronically through the EPA
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/.
A frequently updated electronic version of 40 CFR part 180
is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.
To access the OPPTS Harmonized Guidelines referenced in this document,
go directly to the guidelines at http://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