[Federal Register Volume 67, Number 188 (Friday, September 27, 2002)]
[Rules and Regulations]
[Pages 60960-60966]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-24651]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2002-0233; FRL-7198-8]


Pseudozyma flocculosa strain PF-A22 UL; 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 Pseudozyma flocculosa strain PF-A22 
UL in or on all food commodities. Plant Products Co. Ltd., submitted a 
petition to EPA under the Federal Food, Drug, and Cosmetic Act, as 
amended by the Food Quality Protection Act of 1996, requesting an 
exemption from the requirement of a tolerance. This regulation 
eliminates the need to establish a maximum permissible level for 
residues of Pseudozyma flocculosa strain PF-A22 UL.

DATES: This regulation is effective September 27, 2002. Objections and 
requests for hearings, identified by docket ID number OPP-2002-0233, 
must be received on or before November 26, 2002.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, electronically, or in person. Please follow the detailed 
instructions for each method as provided in Unit IX. of the 
SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, your 
objections and hearing requests must identify docket ID number OPP-
2002-0233 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Sharlene R. Matten, c/o 
Product Manager (PM) 90, Biopesticides and Pollution Prevention 
Division (7511C), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460; telephone number: (703) 605-0514; e-
mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural 
producer, food manufacturer, or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:

 
------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         potentially
                                                       affected entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

    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 the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/. A frequently updated electronic 
version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml --00/Title--40/40cfr180--00.html, a beta site 
currently under development. To access the OPPTS Harmonized Guidelines 
referenced in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm.
    2. In person. The Agency has established an official record for 
this action under docket ID number OPP-2002-0233. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall 2, 1921 Jefferson Davis Hwy., 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of August 30, 2000 (65 FR 52749) (FRL-6739-
8), EPA issued a notice pursuant to section 408 of the Federal Food, 
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), as amended by the 
Food Quality Protection Act (FQPA) (Public Law 104-170), announcing the 
filing of a pesticide tolerance petition (PP 0F6136) by Plant Products 
Co. Ltd., f314 Orenda Rd., Brampton, Ontario, Canada L6T 1G1. This 
notice included a summary of the petition prepared by the petitioner 
Plant Products Co. Ltd. There were no comments received in response to 
the notice of filing.
    The petition requested that 40 CFR part 180 be amended by 
establishing an exemption from the requirement of a tolerance for 
residues of Pseudozyma flocculosa strain PF-A22 UL in or on all food 
commodities.

III. Risk Assessment

    New 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 tolerance is ``safe.'' Section 408(c)(2)(A)(ii) defines ``safe'' to 
mean that ``there is a reasonable certainty that no harm will result 
from aggregate exposure to the

[[Page 60961]]

pesticide chemical residue, including all anticipated dietary exposures 
and all other exposures for which there is reliable information.'' This 
includes exposure through drinking water and in residential settings, 
but does not include occupational exposure. Section 408(b)(2)(C) 
requires EPA to give special consideration to exposure of infants and 
children to the pesticide chemical residue in establishing a tolerance 
and to ``ensure that there is a reasonable certainty that no harm will 
result to infants and children from aggregate exposure to the pesticide 
chemical residue. . . .'' Additionally, section 408(b)(2)(D) requires 
that the Agency consider ``available information'' concerning the 
cumulative effects of a particular pesticide's residues and ``other 
substances that have a common mechanism of toxicity.''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. First, EPA determines the 
toxicity of pesticides. Second, EPA examines exposure to the pesticide 
through food, drinking water, and through other exposures that occur as 
a result of pesticide use in residential settings.

IV. Toxicological Profile

    Consistent with section 408(b)(2)(D) of 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.
    Pseudozyma flocculosa was isolated in 1986 from the leaves of red 
clover, Trifolium pratense, infected with powdery mildew, Erysiphe 
polygoni, by researchers at Agriculture and Agri-Food Canada, Harrow, 
Ontario. Initially, this organism was erroneously identified as a new 
ascomycetous yeast with an anamorphic state in the broad genus 
Sporothrix and a teleomorphic state in the genus Stephanoascus. In 
1995, its taxon was changed to P. flocculosa following ribosomal DNA 
analysis. The genus Pseudozyma contains other smut-like anamorphs, 
including P. rugulosa (formerly Sporothrix rugulosa). P. flocculosa is 
a phyllosphere epiphyte and hyperparasite of primarily powdery mildew 
but has been isolated in association with other leaf-surface molds. It 
is widely distributed in North America (Canada and USA) and in Europe 
on aerial plant surfaces in field or greenhouse agricultural 
ecosystems.
    P. flocculosa antagonizes a number of different powdery mildew 
fungi (Sphaerotheca pannosa var. rosae, Sphaerotheca fulginea, Erysiphe 
graminis var. tritici and Erysiphe polygoni) on many different plants 
in greenhouse and field environments when the relative humidity is 
greater or equal to 70%. This fungus is a necrotroph mycoparasite that 
kills susceptible target host cells upon contact or in close proximity. 
Rapid death and collapse of host cells without penetration is brought 
about by the secretion of three fungitoxic unsaturated C-17 fatty acids 
(9-heptadecenoic acid, 6-methyl-9-heptadecenoic acid and 4-methyl-7,11-
heptadecadienoic acid) and an acyclic norterpene (2, 6, 10, 14, 18-
pentamethyl-2, 6, 8, 10, 12, 14, 17-nonadecaheptene-1,19-diol). The 
fungitoxins disrupt susceptible plasma membranes and cytoplasmic 
organelles within 30 minutes of exposure. The inhibitory response 
includes a loss of proteins and electrolytes. After 24 hours, the host 
cells rapidly collapse and die as a result of the activity of the 
fungitoxins on the host cell's membranes and lipids. Sensitivity to the 
unsaturated C-17 free fatty acids is related to a high degree of 
unsaturation of phospholipid fatty acids and a low proportion of 
sterols.
    P. flocculosa strain PF-A22 UL was considered of low toxicity and 
no pathogenicity based on the results of the Tier I toxicology studies. 
Tier II and Tier III studies were not required because the results from 
the Tier I studies were sufficient to satisfy guideline requirements. 
On the basis of the studies submitted, it was considered a Toxicity 
Category III pesticide for acute oral effects due to the amount dosed 
only, and Toxicity Category IV for dermal and primary dermal irritation 
health effects. These and additional toxicology studies are summarized 
below and in more detail in the Product Monograph for Pseudozyma 
flocculosa strain PF-A22 UL which is found in the OPP docket number 
OPP-2002-0233.
    1. Acute oral toxicity/pathogenicity study (OPPTS 885.3050) (Master 
Record Identification (MRID) numbers 451152-04 and 453634-01). No signs 
of toxicity or pathogenicity were noted when Sporodex WP, a wettable 
powder formulation containing 2.0% (weight/weight) P. flocculosa strain 
PF-A22 UL was administered to rats via the oral route.
    In an acute oral toxicity study, groups of fasted 6-7 week old 
Fisher 344 rats (12/sex) were administered a single oral dose of 
Sporodex WP in USP sterile water for injection at doses of 5.8 x 
108 colony-forming units (CFU) per animal for males and 5.6 
x 108 CFU per animal for females. An equal number of animals 
were dosed with heat-killed test substance and four animals/sex served 
as untreated controls. The animals were then observed for a period of 
up to 21 days with interim scheduled sacrifices. No effect on body 
weight gain and no apparent signs of treatment-related toxicity, 
infectivity or pathogenicity were observed in any of the treated 
animals during the study period. Clearance of the test organism 
occurred by, or prior to, post-treatment day 7. Based on the results of 
this study, Sporodex L and its active ingredient, P. flocculosa, is not 
considered toxic or pathogenic to male or female Fisher 344 rats.
    2. Acute pulmonary toxicity/pathogenicity study (OPPTS 885.3150) 
(MRID numbers 451152-06 and 453634-01). The potential toxicity and 
pathogenicity of P. flocculosa was tested by observing the effects 
following a single intratracheal instillation of 3.2 x 107 
CFU of the test organism (TS) to each of 12 male and 12 female CD rats. 
An equal number of animals were treated with heat-killed test substance 
(KTS) and four animals/sex served as untreated controls. Animals were 
observed for up to 14 days with interim scheduled sacrifices.
    A total of 15 rats (3/8 male and 2/8 female TS-dosed rats and 6/8 
male and 4/8 female KTS-dosed rats) died on days 2 and 3. Laboured 
respiration, rough hair coat, ocular discharge and nasal discharge were 
observed in both TS- and KTS-dosed rats. Hunched posture and lethargy 
were also observed in one female and one male TS-dosed rat, 
respectively. The presence or absence of clinical symptoms were not 
indicative of spontaneous deaths.
    Due to the large number of spontaneous deaths and a number of 
missed data collections, data for evaluating effects on body weights, 
food consumption and relative organ weight were limited. At the end of 
the 14-day long study, administration of P. flocculosa did not have a 
statistically significant effect on body weight. Analyses of daily food 
consumption and relative organ weights were skewed as they were either 
not determined or did not include animals that died prior to their 
scheduled sacrifice dates.
    At necropsy, liver lesions and lesions and enlargement of the lung 
and spleen were observed in both TS- and KTS-dosed rats. Confluent dark 
areas were also seen in the kidneys of a single male TS-dosed rat. 
These necropsy findings were considered consistent with the

[[Page 60962]]

method of dosing and the body's normal immunological response to a 
foreign substance.
    Pseudozyma flocculosa was detected in the lungs and lymph nodes and 
the stomach and small intestine of TS-dosed animals only. Counts in 
these tissues were below the limit of detection by day 7.
    Based on this study, P. flocculosa is toxic, but not infective or 
pathogenic, at the dose administered when introduced by the 
intratracheal route to male and female CD rats. This acute pulmonary 
study, however, was originally classified as unacceptable due to major 
deficiencies in the collected data and a possible dosing error, as 
indicated by the presence of the microbial pest control agent (MPCA) in 
the stomach and small intestines on the day of dosing. However, there 
was relevant pathogenicity information that indicated clearance of the 
MPCA. Thus, this study is considered to be supplemental because it 
provides acceptable information regarding infectivity/pathogenicity; 
however, this study does not differentiate the cause of certain 
mortalities in the TS and KTS treatments. A confirmatory acute 
pulmonary toxicity/pathogenicity study using the technical grade of the 
active ingredient (TGAI) and testing of the sterile filtrate from the 
production culture will therefore be required to provide this 
additional information as a condition of registration.
    3. Acute pulmonary range-finding study (OPPTS 885.3150) (MRID 
numbers 451152-07 and 453634-01). In order to determine whether the 
test substance (in both its viable and non-viable forms), P. 
flocculosa, was the cause of the deaths, a subsequent acute pulmonary 
range-finding toxicity study was conducted. In this range-finding 
study, groups of young adult CD rats (5/sex/dose level) were exposed by 
the intratracheal route to P. flocculosa (4.2 x 107 CFU/mL) 
in ASTM Type 1 water at doses of 4.2 x 107, 3.4 x 
107, 6.8 x 106 and 3.4 x 106 CFU/
animal. Animals were then observed for 14 days. There were no 
mortalities and all animals gained weight during the study. Rough hair 
coat occurred in a dose-dependent manner with all 5 animals/sex 
exhibiting this symptom at the highest dose of 4.2 x 107 
CFU/animal. One female dosed with 4.2 x 107 CFU experienced 
tremors, closed eyes and rough hair coat. Pseudozyma flocculosa was 
classified as being of slight toxicity (EPA Toxicity Category IV) based 
on adverse effects observed in some test animals.
    This acute pulmonary study was considered supplemental. According 
to USEPA OPPTS 885.3150, the minimum dose is 108 units of 
the MPCA per test animal. The maximum dose level used in this study, 
however, was only 4.2 x 107 CFU/animal. Furthermore, 
infectivity was not addressed; however, the acute pulmonary toxicity/
pathogenicity study did address infectivity sufficiently. Consequently, 
this study does not satisfy the guideline requirement for an acute 
pulmonary study (OPPTS 885.3150) in the rat. EPA, in considering the 
two studies together, believes that there are sufficient data with 
which to determine the toxicity and pathogenicity of Pseudozyma 
flocculosa. As any potential inhalation risk that is raised by these 
studies is primarily a worker risk, EPA is requiring that a respirator 
be worn by workers to limit any inhalation exposures. In addition, a 
Restricted-Entry Interval (REI) of 4 hours is required for early entry 
(post-application) workers or other persons entering treated 
greenhouses. Finally, a confirmatory acute pulmonary toxicity/
pathogenicity study using the TGAI and testing of the sterile filtrate 
from the production culture will be required as a condition of 
registration.
    4. Intraperitoneal toxicity/infectivity study (OPPTS 885.3200) 
(MRID numbers 451152-08 and 453634-01). In an acute intraperitoneal 
toxicity/infectivity study, groups of young adult CD rats (4/sex/
scheduled sacrifice date) were exposed by the intraperitoneal route to 
an undiluted suspension of P. flocculosa (TS) at a dose of 3.5 x 
107 CFU/animal (in 1.0 mL). Animals were then observed for 
up to 14 days. An equal number of young adult CD rats were similarly 
injected with heat-killed test substance (KTS). An undosed naive 
control (NC) group consisting of 4 rats/sex was also included in the 
study. Cage side observation for clinical symptoms was performed daily 
and animal body weights and food consumption were monitored.
    No unscheduled deaths occurred. Designated animals from the TS and 
KTS groups were sacrificed on days 0, 7, and 14 and gross necropsies 
were performed. The NC group of animals was sacrificed and necropsied 
at the end of the 14-day study. Infectivity and clearance were assessed 
by quantitatively recovering the MPCA from the blood, lungs and lymph 
nodes, spleen, kidneys, liver, heart, stomach and small intestine, 
peritoneal fluid, caecum and brain.
    No adverse clinical signs were observed at any point of the study 
in any of the groups of rats. Body weight gain of TS-dosed male rats 
was significantly decreased while this group's food consumption was 
significantly increased compared to NC animals. There was no 
significant difference between KTS-dosed and NC animals in terms of 
body weight, body weight gain or food consumption. Upon necropsy of TS- 
and KTS-dosed animals, white nodules and higher relative spleen weights 
were observed and attributed to a normal immune response to a foreign 
substance. The detection of P. flocculosa in the peritoneal fluid 
lavage of TS-dosed male rats was consistent with the method of 
administration. Clearance of P. flocculosa from all other tissues and 
fluids occurred by day 7. No test substance was detected from any of 
the organs of the KTS-dosed or NC animals.
    At the dose administered, P. flocculosa was slightly toxic but not 
pathogenic to male and female CD rats when introduced by the 
intraperitoneal route.
    5. Acute dermal toxicity/irritation study (OPPTS 885.3100) (MRID 
numbers 451152-09 and 453634-01). In an acute dermal toxicity study, a 
single group of New Zealand White rabbits (5/sex) was dermally exposed 
to 1.2 x 107 CFU P. flocculosa (equivalent to approximately 
0.82-0.90 g/kg bw for males and 0.80-0.91 g/kg bw for females), for 24 
hours to an area equivalent to approximately 10% of the dorsal skin 
surface. Following exposure, the animals were observed for a period of 
14 days.
    No treatment-related signs of toxicity or skin irritation were 
observed in any animal during the 14-day observation period. At the 
dose administered, P. flocculosa was not considered toxic or irritating 
to the skin.
    6. Primary eye irritation study (OPPTS 870.2400) (MRID numbers 
451152-10 and 453634-01). Administration of 0.1 g of Sporodex WP to the 
eyes of rabbits resulted in slight conjunctival redness in 5/6 animals 
at the 1-hour scoring interval and in 2/6 rabbits at the 24-hour 
scoring interval. By the 48-hour scoring interval, all signs of ocular 
irritation had subsided. There were no other adverse clinical symptoms 
or mortalities during the 7-day observation period. The maximum 
irritation score (MIS) was 1.7 at the 1-hour scoring interval and the 
maximum average score (MAS) was 0.22 over the 24-, 48- and 72-hour 
scoring intervals. Based on the MAS, Sporodex WP was classified as 
minimally irritating.
    7. Subchronic, chronic toxicity and oncogenicity. Survival, 
replication, infectivity, significant toxicity or persistence of the 
MPCA was not observed in the test animals treated in Tier I acute oral, 
pulmonary and intravenous toxicity/infectivity tests.

[[Page 60963]]

 Consequently, higher tier tests involving subchronic and chronic 
testing, oncogenicity testing, mutagenicity and teratogenicity were not 
required based on the lack of concerns following analysis of Tier I 
test results. However, a genotoxicity computer search for Pseudozyma 
flocculosa was conducted. No reports of mammalian toxicity were found 
in standard biological, chemical and toxicological abstracts. The 
applicant included computer literature search results to a number of 
keywords such as pseudozyma; tilletiopsis, fate, non target, carcin, 
mutagen; toxic, pathogen, antibiotic, polyen; sporothrix, 
sporobolomyces, rhodotorula, phyllosphere yeast; carcinog and 
teratogen. The literature search covered AGRICOLA, Biological 
Abstracts, CAB Abstracts, CHEMTOX, RTEX and AGRIS databases from 1980 
to 1999.
    8. Hypersensitivity (dermal sensitization) study (OPPTS 870.2600). 
The applicant has also submitted an acceptable waiver rationale from 
conducting a dermal sensitization study based on the assumption that 
most microorganisms contain substances that could elicit a 
hypersensitivity response. Pseudozyma flocculosa is considered a 
potential sensitizing agent, therefore, the statement, ``POTENTIAL 
SENSITIZER'' is required on the principal display panels of the 
technical and end-use formulation labels. The use of personal 
protective equipment will also be required to mitigate against 
potential dermal sensitization in occupationally exposed workers/
handlers.
    9. Reports of hypersensitivity incidents (OPPTS 885.3400). Skin 
sensitizing studies are not considered substitutes for timely reports 
of hypersensitivity incidents subsequent to registration approval. No 
adverse effects have been noted among researchers who have worked 
closely with P. flocculosa strain PF-A22 UL for up to 10 years. The 
applicant will be expected to report any subsequent findings of 
hypersensitivity or other health incidents to workers, applicators, or 
bystanders exposed to the MPCA as a condition of registration. Incident 
reports are to include details such as a description of the MPCA and 
formulation, frequency, duration and routes of exposure to the 
material, clinical observations, and any other relevant information.
    10. Effects on the immune systems (OPPTS 880.3800, immune 
response). The active ingredient, P. flocculosa strain PF-A22 UL, is 
not known to be a human pathogen nor an endocrine disrupter. The 
submitted toxicity/pathogenicity studies in the rodent indicate that, 
following several routes of exposure, the immune system is still intact 
and able to process and clear the active ingredient. Therefore, no 
adverse effects to the immune systems are known or expected. Based on 
this rationale, the registrant waiver request for OPPTS 880.3800 
(Immune Response) was found to be acceptable.

V. Aggregate Exposures

A. Dietary Exposure

    In examining aggregate exposure, FFDCA section 408 directs EPA to 
consider available information concerning exposures from the pesticide 
residue in food and all other non-occupational exposures, including 
drinking water from ground water or surface water and exposure through 
pesticide use in gardens, lawns, or buildings (residential and other 
indoor uses).
    1. Food. The proposed food use pattern is likely to result in 
residues in or on food and feed. Residues of the microbial pesticide 
are likely to be removed from treated food by washing, peeling, cooking 
and processing. Even if residues are not removed, however, EPA believes 
that dietary exposure to the microbial agent will result in negligible 
to no risk to consumers. Although Pseudozyma species are ubiquitous in 
nature and have been isolated from a wide variety of plant surfaces 
including leaf litter, clover, maize and cucumber, no adverse effects 
from dietary exposure have been attributed to natural populations of 
Pseudozyma flocculosa. Furthermore, no adverse effects were observed at 
maximum hazard dose levels in the acute oral toxicity/pathogenicity 
study and there are no reports of known mammalian toxins being produced 
by the MPCA. Subchronic and chronic dietary exposure studies were not 
required because the Tier I acute oral study demonstrated a low level 
of toxicity and no pathogenicity potential for the active 
microorganism. Because of the low toxicity profile and low potential 
exposure of the MPCA expected for the proposed uses, there is no 
concern for chronic risks posed by dietary exposure for the general 
population or sensitive subpopulations, such as infants and children. 
In addition, an extensive literature search yielded no reports of 
mammalian toxins being produced by P. flocculosa. The fungitoxic 
unsaturated C-17 fatty acids and acyclic norterpene produced by the 
MPCA have not been reported to be toxic to mammals. Neither this 
organism nor its close relatives are listed among microbial 
contaminants of food. Therefore, EPA expects negligible to no dietary 
risk from exposure to naturally-occurring and isolated P. flocculosa 
strain PF-A22 UL residues.
    2. Drinking water exposure. Although heavy rainfall likely carries 
P. flocculosa into neighboring aquatic environments, growth and 
survival of terrestrial fungi such as P. flocculosa is limited in such 
environments. Thus, it is not expected to proliferate in aquatic 
habitats following incidents of direct or indirect exposure (e.g., 
runoff from treated greenhouses). Moreover, P. flocculosa is not 
considered to pose a risk to humans from exposure to drinking water 
because of minimal to non-existent toxicity. Accordingly, drinking 
water is not specifically screened for P. flocculosa as a potential 
indicator of microbial contamination or as a direct pathogenic 
contaminant. Both percolation through soil and municipal treatment of 
drinking water would reduce the possibility of significant transfer of 
residues to drinking water. Therefore, the potential of exposure and 
risk via drinking water is likely to be minimal to non-existent for 
this MPCA.

B. Other Non-Occupational Exposure

    The current label does not allow applications to turf, residential 
or recreational areas. Because the use sites are in greenhouses, 
exposure to the U.S. population including infants and children in 
school, residential and daycare facilities is likely to be minimal to 
non-existent. Consequently, the health risk posed by P. flocculosa 
strain PF A-22 UL from non-occupational dermal and inhalation exposures 
to the general public, including infants and children, is expected to 
be negligible to non-existent. Any concerns for potential inhalation 
risk is for occupational exposures, and as mentioned previously, will 
be mitigated by the requirement of a respirator and restriction of the 
reentry interval.

VI. Cumulative Effects

    The Agency has considered available information on the cumulative 
effects of such residues and other substances that have a common 
mechanism of toxicity. These considerations included the cumulative 
effects on infants and children of such residues and other substances 
with a common mechanism of toxicity. EPA is not aware of any other 
bacteria or other substances, besides naturally-occurring strains of 
Pseudozyma, that share a common mechanism of toxicity with this active 
ingredient. Given the low toxicity and pathogenicity profile of P. 
flocculosa, even if there were any other substances with which P. 
flocculosa shared a

[[Page 60964]]

common mechanism of toxicity, no adverse cumulative effects are 
expected.

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

    Based on the toxicology data submitted and other relevant 
information in the Agency's files, there is reasonable certainty no 
harm will result from aggregate exposure of residues of Pseudozyma 
flocculosa strain PF-A22 UL to the U.S. population, including infants 
and children, under reasonably foreseeable circumstances when the 
microbial pesticide product is used as labeled. This includes all 
anticipated dietary exposures and all other exposures for which there 
is reliable information. The Agency has arrived at this conclusion 
based on data submitted demonstrating low toxicity at the maximum doses 
tested and a lack of information showing adverse effects from exposure 
to naturally occurring P. flocculosa as well as a consideration of the 
product as currently registered and labeled. As a result, EPA 
establishes an exemption from tolerance requirements pursuant to FFDCA 
408(c) and (d) for residues of Pseudozyma flocculosa strain PF-A22 UL 
in or on all food commodities.
    FFDCA section 408 provides that EPA shall apply an additional 
tenfold margin of exposure (safety) for infants and children in the 
case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data base unless EPA determines 
that a different margin of exposure (safety) will be safe for infants 
and children. Margins of exposure (safety) are often referred to as 
uncertainty (safety) factors. In this instance, based on all the 
available information, the Agency concludes that P. flocculosa strain 
PF-A22 UL is practically non-toxic to mammals, including infants and 
children. Thus, there are no threshold effects of concern and, as a 
result the provision requiring an additional margin of safety does not 
apply. Further, the provisions of consumption patterns, special 
susceptibility, and cumulative effects do not apply. As a result, EPA 
has not used a margin of exposure (safety) approach to assess the 
safety of P. flocculosa strain PF-A22 UL.

VIII. Other Considerations

A. Endocrine Disruptors

    EPA does not have any information regarding endocrine effects of 
this microbial pesticide at this time. There is no evidence to suggest 
that use of P. flocculosa strain PF-A22 UL at the proposed 
concentrations will adversely affect the endocrine system. The active 
ingredient, P. flocculosa strain PF-A22 UL, is not known to be a human 
pathogen nor an endocrine disrupter. The submitted toxicity/
pathogenicity studies in the rodent indicate that, following several 
routes of exposure, the immune system is still intact and able to 
process and clear the active ingredient. Therefore, no adverse effects 
to the endocrine systems are known or expected.

B. Analytical Method(s)

    As part of the standard Quality Control measures, the Agency is 
requiring microbial assays and analytical methods to identify the 
active ingredient and potential contaminants. Analytical methods are 
available and sufficient to identify metabolites and contaminants 
within regulatory levels. All batches containing potential human 
pathogens are to be destroyed. The MPCA is identified using a 
combination of morphological traits, molecular techniques and 
biological activity.
    The identification of Pseudozyma to the species level is done using 
a standard mycological approach. Pseudozyma species can be 
differentiated from morphologically similar species such as 
Hyalodendron, Tilletiopsis, Sporobolomyces and Sporothrix. The 
branching conidiophores of Pseudozyma can be confused with those 
produced by Hyalodendron; however, the whole cell hydrolysates of this 
filamentous basidiomycete contain xylose which is not found in 
Pseudozyma. Tilletiopsis and Sporobolomyces, other saprophytic wild 
yeasts on aerial plant surfaces, are different from Pseudozyma in that 
they produce spores that are forcibly discharged upon sporulation 
(ballistospores). Furthermore, Tilletiopsis species produce a fungus-
degrading [beta]-1,3 glucanase that is not produced by Pseudozyma 
species. The genus Sporothrix represents a group of anamorphic 
ascomycetous yeasts such as Sporothrix schenckii (type), an animal 
pathogen. Physiologically, Pseudozyma species differ greatly from 
Sporothrix species. Unlike the ascomycetous Sporothrix anamorphs, P. 
flocculosa shows positive reactions in Diazonium Blue B and urease 
tests typical of all basidiomycetous yeasts. Also, the major ubiquinone 
is Q-10 rather than Q-8 or Q-9 typical of the ascomycetes, 
Saccharomycopsis and Stephanoascus.
    Strain PF-A22 UL can be differentiated from other strains of P. 
flocculosa using a DNA-based technique called multiplex polymerase 
chain reaction (multiplex PCR). The multiplex PCR system is essentially 
a cocktail of different primers which allows the rapid assessment of 
numerous DNA fragments in a single PCR amplification. The protocol is 
based on the amplification of two nuclear regions, (ITS and NS), and 
one mitochondrial region (ML). Those regions were found to be 
discriminant in the identification of P. flocculosa PF-A22 UL.
    The integrity and consistency of the MPCA is ensured by two 
methods. The first method is a DNA-based PCR technique called random 
amplified microsatellites PCR (RAMS). Microsatellites are hypervariable 
non-coding regions of DNA within the genome that evolve more rapidly 
than coding DNA. The other method is a bioassay that measures 
biological activity. The biological activity of the MPCA is measured by 
the inhibition zone created when a susceptible organism is grown next 
to it. Given that the pest controlled, Sphaerotheca species, is an 
obligate biotroph, it cannot be used directly in this bioassay. 
Instead, a Phomopsis species is used because its sensitivity to P. 
flocculosa's fungitoxic secretions is similar.

C. Codex Maximum Residue Level

    There are no Codex Maximum Residue Levels or exemption from 
tolerances for the microbial active ingredient Pseudozyma flocculosa 
strain PF-A22 UL.

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 of 1996, EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) provides essentially 
the same process for persons to ``object'' to a regulation for an 
exemption from the requirement of a tolerance issued by EPA under new 
section 408(d), as was provided in the old FFDCA sections 408 and 409. 
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

[[Page 60965]]

178. To ensure proper receipt by EPA, you must identify docket ID 
number OPP-2002-0233 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 26, 2002.
    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 (1900C), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your request to the Office 
of the Hearing Clerk in Rm. 104, Crystal Mall 2, 1921 
Jefferson Davis Hwy., Arlington, VA. 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 
(703) 603-0061.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460.
    3. 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 Unit I.B.2. Mail your 
copies, identified by docket ID number OPP-2002-0233, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 
In person or by courier, bring a copy to the location of the PIRIB 
described in Unit I.B.2. You may also send an electronic copy of your 
request via e-mail to: [email protected]. 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. Regulatory Assessment Requirements

    This final rule establishes an exemption from the tolerance 
requirement under FFDCA section 408(d) 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 FFDCA section 408(d), such as the exemption in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. 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

[[Page 60966]]

retailers, not States. This action does not alter the relationships or 
distribution of power and responsibilities established by Congress in 
the preemption provisions of FFDCA section 408(n)(4). 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. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and 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 19, 2002.
James Jones,
Acting Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

    Authority: 21 U.S.C. 321(q), 346(a) and 374.

    2. Section 180.1221 is added to subpart D to read as follows:


Sec.  180.1221  Pseudozyma flocculosa strain PF-A22 UL; exemption from 
the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of Pseudozyma flocculosa strain PF-A22 UL in or on all food 
commodities.

[FR Doc. 02-24651 Filed 9-26-02; 8:45 am]
BILLING CODE 6560-50-S