[Federal Register Volume 64, Number 172 (Tuesday, September 7, 1999)]
[Rules and Regulations]
[Pages 48548-48560]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-23194]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300916; FRL-6380-7]
RIN 2070-AB78


Avermectin B1 and its delta-8,9-isomer; Pesticide 
Tolerance

AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for combined residues 
of the insecticide avermectin B1 (a mixture of avermectins 
containing greater than or equal to 80% avermectin B1a (5-O-
demethyl avermectin A1) and less than or equal to 20% 
avermectin B1b (5-O-demethyl-25-de(1-methylpropyl)-25-(1-
methylethyl) avermectin A1)) and its delta-8,9-isomer in or 
on grapes at 0.02 parts per million (ppm), peppers at 0.02 ppm, and 
cotton gin byproducts at 0.15 ppm; makes permanent tolerances for 
citrus, hops, potatoes, meat and meat by-products, milk, and cotton 
seed which were previously time limited (expiring September 1, 1999); 
and clarifies that permanent tolerances have previously been 
established for almond hulls at 0.10 ppm and wet apple pomace at 0.10 
ppm. Novartis Crop Protection, Inc. requested these tolerance actions 
under the Federal Food, Drug, and Cosmetic Act, as amended by the Food 
Quality Protection Act of 1996.
DATES: This regulation is effective September 7, 1999. Objections and 
requests for hearings, identified by docket control number OPP-300916, 
must be received by EPA on or before November 8, 1999.
ADDRESSES:  Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VI. of the ``SUPPLEMENTARY 
INFORMATION'' section. To ensure proper receipt by EPA, your objections 
and hearing requests must identify docket control number OPP-300916 in 
the subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: By mail: Thomas C. Harris, 
Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460; 
telephone number: (703) 308-9423; and 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 Potentially
              Categories                NAICS       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

[[Page 48549]]

(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 in the ``FOR FURTHER 
INFORMATION CONTACT'' section.

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'' 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/.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-300916. 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

    This regulation addresses three tolerance actions concerning 
avermectin B1 and its delta-8,9-isomer.

A. New Tolerances

    In the Federal Register of August 11, 1997 (62 FR 42980) (FRL-5736-
1), EPA issued a notice pursuant to section 408 of the Federal Food, 
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the Food 
Quality Protection Act of 1996 (FQPA) (Public Law 104-170) announcing 
the filing of a pesticide petition (PP 7F4844) for tolerance by Merck 
Research Laboratories, PO Box 450, Hillsborough Rd, Three Bridges, NJ. 
The petition was later transferred to Novartis Crop Protection, Inc., 
PO Box 18300, Greensboro, NC 27419. There were no comments received in 
response to the notice of filing.
    The initial petition requested that 40 CFR 180.449 be amended by 
establishing a tolerance for combined residues of the insecticide 
avermectin B1 (a mixture of avermectins containing greater 
than or equal to 80% avermectin B1a (5-O-demethyl avermectin 
A1) and less than or equal to 20% avermectin B1b 
(5-O-demethyl-25-de(1-methylpropyl)-25-(1-methylethyl) avermectin 
A1)) and its delta-8,9-isomer, in or on grapes, raisins, and 
other grape-derived food items at 0.02 ppm and chili peppers at 0.01 
ppm. The petition was subsequently revised to express the tolerance as 
simply peppers (combining the proposed chili peppers with the existing 
0.01 ppm bell pepper tolerance) and raising the level to 0.02 ppm to 
harmonize the tolerance with international residue limits. In addition, 
the petition was also revised to express the proposed tolerance as 
simply grapes at 0.02 ppm since residue data showed that separate, 
higher tolerance levels were not needed for raisins and other grape-
derived food items as expressed in the original petition.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish 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(b)(2)(A)(ii) 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. 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....''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 and a complete description of 
the risk assessment process, see the final rule on Bifenthrin Pesticide 
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

B. Conversion of Certain Tolerances from Time-limited to Permanent

    In the Federal Register of July 29, 1999 (64 FR 41112) (FRL-6095-
6), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 
346a as amended by the FQPA (Public Law 104-170) announcing the filing 
of a pesticide petition (PP) by Novartis Crop Protection, Inc., PO Box 
18300, Greensboro, NC 27419 to convert certain time limited tolerances 
due to expire September 1, 1999 to permanent tolerances and to add a 
new tolerance for a feed commodity. There were no comments received in 
response to the notice of filing.
    The petition referenced pesticide petitions PP 8F3592, 7F3500, 
4E4419 and 5F4508. It requested that 40 CFR 180.449 be amended by 
establishing permanent tolerances for combined residues of the 
insecticide avermectin B1 (a mixture of avermectins 
containing greater than or equal to 80% avermectin B1a (5-O-
demethyl avermectin A1) and less than or equal to 20% 
avermectin B1b (5-O-demethyl-25-de(1-methylpropyl)-25-(1-
methylethyl) avermectin A1)) and its delta-8,9-isomer, in or 
on the agricultural commodities cattle, fat at 0.015 ppm; cattle, meat 
byproducts at 0.02 ppm; cattle, meat at 0.02 ppm; citrus, dried pulp at 
0.10 ppm; citrus, oil at 0.10 ppm; citrus, whole fruit at 0.02 ppm; 
cotton seed at 0.005 ppm; cotton gin by-products at 0.15 ppm; hops, 
dried at 0.20 ppm; milk at 0.005 ppm; and potatoes at 0.005 ppm.
    With the exception of cotton gin by-products, these tolerances were 
previously established as time-limited tolerances with an expiration 
date of September 1, 1999 (see Federal Register of March 24, 1997 (62 
FR 13833) (FRL-5597-7) to allow for resolution of the following three 
issues:
    1. The petitioner had to submit field residue trial data for cotton 
gin byproducts and the EPA had to reevaluate dietary risk with respect 
to secondary residues in meat and milk. These data were submitted; the 
review is discussed later in this rule. As a result of this review, the 
July 29, 1999 notice proposed the new tolerance for cotton gin 
byproducts at 0.15 ppm.
    2. The EPA needed to fully review the Monte Carlo analysis for 
acute dietary risk submitted by the petitioner (especially the 
anticipated residues and percent of crop treated data used). This 
review was conducted as part of the tolerance assessment for grapes and 
peppers.

[[Page 48550]]

    3. The EPA needed to fully review the indoor residential risk 
assessment submitted by the petitioner. This review was conducted as 
part of the tolerance assessment for grapes and peppers. Since all 
three issues have been satisfactorily addressed, the petitioner is 
seeking to make the tolerances permanent.

C. Clarification: Certain Feed Tolerances Previously Established

    In the Federal Register of April 10, 1996 (61 FR 15900) (FRL-5361-
9), EPA issued a final rule pursuant to section 409(e) of the FFDCA, 21 
U.S.C. 348(b) announcing permanent tolerances under 40 CFR 186.300 for 
combined residues of the insecticide avermectin B1 (a 
mixture of avermectins containing greater than or equal to 80% 
avermectin B1a (5-O-demethyl avermectin A1) and 
less than or equal to 20% avermectin B1b (5-O-demethyl-25-
de(1-methylpropyl)-25-(1-methylethyl) avermectin A1)) and 
its delta-8,9-isomer, in or on the processed feed commodities apples, 
wet pomace at 0.10 ppm and almonds, hulls at 0.10 ppm. This regulation 
also established permanent tolerances under 40 CFR 180.449 on the raw 
agricultural commodities almonds at 0.005 ppm; apples at 0.020 ppm; and 
walnuts at 0.005 ppm.
    Although that final rule listed tolerances for both raw 
agricultural commodities and feed commodities, the 1996 edition of 40 
CFR parts 150-189 (revised as of July 1, 1998), and subsequent 
editions, listed only the tolerances for the raw agricultural 
commodities and did not list the feed commodities established by this 
regulation. With this current regulation the Agency is clarifying that 
tolerances have been legally in effect since April 10, 1996 for the 
processed feed commodities apples, wet pomace at 0.10 ppm and almonds, 
hulls at 0.10 ppm. Due to amendments to the FFDCA by the FQPA, all 
(i.e. raw, processed, and feed commodity) tolerances for avermectin 
B1 and its delta-8,9-isomer are now listed in the same 
section of 40 CFR (180.449).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of 
avermectin B1 and its delta-8,9-isomer and to make a 
determination on aggregate exposure, consistent with section 408(b)(2), 
for a tolerance for combined residues of the insecticide avermectin 
B1 (a mixture of avermectins containing greater than or 
equal to 80% avermectin B1a (5-O-demethyl avermectin 
A1) and less than or equal to 20% avermectin B1b 
(5-O-demethyl-25-de(1-methylpropyl)-25-(1-methylethyl) avermectin 
A1)) and its delta-8,9-isomer on grapes at 0.02 ppm and 
peppers at 0.02 ppm. EPA's assessment of the dietary exposures and 
risks associated with establishing the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies 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. The nature of the toxic effects caused by avermectin 
B1 and its delta-8,9-isomer are discussed in this unit.
    1. Acute toxicity/skin sensitization. The following summarizes the 
acute toxicity of technical grade avermectin B1: the acute 
oral LD50 is 13.6 milligrams/kilogram (mg/kg) (toxicity 
category I); the acute dermal LD50 is 2,000 mg/kg (toxicity 
category III); acute inhalation requirements were waived; primary eye 
irritation results show the chemical to be very irritating exhibiting 
corneal opacity, conjunctivitis, and iritis (toxicity category II); 
primary skin irritation results show slight irritation (toxicity 
category III); dermal sensitization results are negative.
    2. Subchronic toxicity. In a 14-Week Oral Toxicity Study in Rats, 
groups of 15 male and 15 female Charles River CD rats were gavaged with 
0, 0.1, 0.2, or 0.4 mg/kg/day of C-076 (avermectin B1). The 
rats had previously been exposed in utero to avermectin B1 
at doses of 0, 0.01, 0.2, or 0.4 mg/kg/day. No toxic signs or deaths 
were noted in any of the treatment groups. Body weight gain was 
increased in the rats dosed at 0.4 mg/kg/day. There were no treatment-
related ophthalmologic changes, clinical pathology anomalies, gross or 
histopathologic lesions, or changes in organ weights. The No Observable 
Adverse Effect Level (NOAEL) is > 0.4 mg/kg/day, the highest dose 
tested.
    An 18-Week Oral Toxicity Study in Dogs resulted in a NOAEL of 0.25 
mg/kg/day with the Lowest Observed Adverse Effect Level (LOAEL) being 
0.5 mg/kg/day based on body tremors, one death, liver pathology, and 
decreased body weight.
    3. Chronic toxicity/ongogenicity/carcinogenicity. In a Combined 
Chronic Toxicity/Oncogenicity Study in Rats, the oncogenic potential 
was negative up to 2.0 mg/kg/day, the highest dose tested (HDT). The 
high dose was increased to 2.5 mg/kg/day between weeks 10 and 13. The 
high-dose is considered the Maximum Tolerated Dose (MTD). The systemic 
NOAEL is 1.5 mg/kg/day (mid-dose). The LOAEL is 2.0 mg/kg/day based on 
tremors in both sexes. A mid-dose female that had tremors was found to 
have received a dose of about 2.5 mg/kg/day (based on actual food 
consumption and body weight data). No pathological lesions could be 
found to explain the tremors.
    In a Carcinogenicity Study in Mice, oncogenic potential was 
negative up to 8 mg/kg/day, the HDT. The high-dose (8 mg/kg/day) is 
considered the MTD. The systemic NOAEL is 4 mg/kg/day. The LOAEL is 8 
mg/kg/day based on increased incidence of dermatitis in males, an 
increased incidence of extra-medullary splenic hematopoiesis in males, 
increased mortality in males, and tremors and body weight decrease in 
females.
    In a 53-Week Oral Toxicity Study in Dogs, the NOAEL is 0.25 mg/kg/
day, and the LOAEL is 0.50 mg/kg/day based on a high incidence of 
mydriasis (dilatation of the pupil of the eye) in males and females.
    4. Developmental and reproductive toxicity. In a Developmental 
Toxicity Study in Rats, groups of 25 female CRCD rats were mated, then 
dosed by gavage with technical MK-0936 (avermectin B1) at 0 
(vehicle control), 0.4, 0.8, or 1.6 mg/kg/day on gestation days 6 
through 19. The lack of any maternal or developmental toxicity 
demonstrates that the doses selected for this study were too low to 
establish a LOAEL. The maternal and developmental NOAELs are > 1.6 mg/
kg/day (the HDT).
    In a Developmental Toxicity Study in Rabbits, the maternal NOAEL is 
1.0 mg/kg/day, and the maternal LOAEL is 2.0 mg/kg/day based on 
decreased body weights, food consumption, and water consumption. The 
developmental NOAEL is 1.0 mg/kg/day, and the Developmental LOAEL is 
2.0 mg/kg/day based on cleft palate, clubbed foot, and delayed 
ossification of sternebrae, metacarpals, and phalanges.
    In a 2-generation Reproduction Study in Rats, the systemic and 
reproductive NOAELs are  0.40 mg/kg/day. The developmental 
NOAEL is 0.12 mg/kg/day, and the developmental LOAEL is 0.40 mg/kg/day 
based on decreased pup body weight and viability during lactation, and 
increased incidence of retinal rosettes in F2b weanlings.
    In a Special Developmental Toxicity Study in CF-1 Mice, a genotypic 
susceptibility to cleft palate was seen

[[Page 48551]]

following in utero exposure of avermectin B1 delta 8-9 
isomer (an isomeric photodegradation product found in plants). P-
glycoproteins are large proteins (150-180 kDa) found in the cell 
membranes of animals ranging from sponges to humans. Groups of 12 P-
glycoprotein molecules span the lipid bilayer to form pores that 
protect the cell by secreting toxic chemicals (such as the avermectins) 
at the expense of ATP.
    The CF-1 mouse strain is unique in that it contains a spontaneous 
mutation in the P-glycoprotein gene resulting in heterogeneity in the 
expression of the protein, a component of the blood-brain and blood-
placental barrier. Mice with a  or -/- genotype have 
decreased expression of this protein. A decrease in expression of the 
P-glycoprotein in both the gastrointestinal tract and brain increased 
the sensitivity of CF-1 mice to avermectin toxicity by increasing its 
absorption. Because the protein is also a component of the placental-
blood barrier, it was hypothesized that a deficiency of this protein in 
the placenta may increase the sensitivity of the fetus to the 
avermectins. In this exploratory developmental toxicity study, the role 
of fetal P-glycoprotein genotype in the development of cleft palate in 
CF-1 mice was investigated.
    Heterozygous () male and female mice for P-glycoprotein 
expression were mated. The dams were dosed by gavage with 1.5 mg/kg/day 
of the test article on gestation days 6-15, inclusive. The pups had the 
typical 1:2:1 Mendelian expression of P-glycoprotein deficiency (+/+, 
, and -/-, respectively).
    There was a clear correlation between fetal P-glycoprotein genotype 
and cleft palate incidence. Cleft palate was observed in 97% of fetuses 
with the -/- genotype, 41% of fetuses with the  genotype, 
and none of the fetuses with the +/+ genotype. It was postulated that 
placental P-glycoprotein limited the potential of the test article to 
induce cleft palate in the fetuses, presumably by regulating the amount 
of test material allowed to cross the placental barrier into the 
developing fetus.
    The literature contains no mention of P-glycoprotein deficiency in 
humans, and several scientists who are researching P-glycoprotein 
confirmed this. Since there is no known human correlate for P-
glycoprotein deficiency, the CF-1 mouse should not be used for 
assessing the risk of human exposure to avermectins. Although several 
developmental toxicity studies were performed using CF-1 mice, they are 
inappropriate for regulatory purposes.
    5. Mutagenicity. The available studies clearly indicate that 
avermectin B1, delta-8,9-isomer (a plant metabolite), and 
the polar photolysis degradates are not mutagenic in microbial systems. 
While avermectin B1 has the potential to damage DNA, the 
lack of an in vitro mutagenic or clastogenic effect correlates well 
with the lack of an oncogenic effect in rat or mouse long-term feeding 
studies and also with the absence of significant reproductive or 
developmental toxicity attributable to a mutagenic mode of action 
(i.e., decreased total implants or increased resorptions).
    6.  Metabolism. In a metabolism study in rats, two metabolites were 
identified, 2,4-OH-ME-B1a, and 3''desmethyl avermectin 
B1a (3''DM-B1a). No bioaccumulation was seen in 
rat tissues.
    7. Neurotoxicity. There are no neurotoxicity or developmental 
neurotoxicity studies of avermectin B1. However, 
neurotoxicity was observed in other oral toxicity studies. A chronic 
study in dogs resulted in mydriasis at 0.50 mg/kg/day. A chronic/
oncogenicity study in rats resulted in tremors in both sexes at the 
LOAEL of 2.0 mg/kg/day. A chronic/carcinogenicity study in mice 
resulted in tremors in females at the LOAEL of 8 mg/kg/day. In an 18-
week study in dogs signs, seen at 0.50 mg/kg/day included mydriasis, 
whole body tremors, ataxia (lack of coordination), muscular tremors, 
and ptyalism (excessive flow of saliva). In a 10-day developmental 
toxicity study in CF-1 mice, hunched back and marked tremors were 
observed after 6-7 days dosing at 0.3 mg/kg/day in the diet. In a 
reproduction study in rats, spastic movements of the limbs and muscular 
tremors of the entire body were seen in lactating pups, but not in the 
dams, at 0.4 mg/kg/day. In a reproduction study in rats, whole body 
tremors, ataxia, ptyalism, and ocular and/or nasal discharges were seen 
in dams dosed at 2.0 mg/kg/day (no mention of neurotoxicity in the 
pups). In two developmental toxicity studies in CF-1 mice, death was 
preceded by tremors, then coma.

B. Toxicological Endpoints

    1. Acute toxicity. An acute dietary Reference Dose (RfD) of 0.0025 
mg/kg was based on data from a 1-year dog study. The NOAEL is 0.25 mg/
kg/day, and the LOAEL is 0.50 mg/kg/day based on mydriasis which was 
observed after 1 week of dosing. An uncertainty factor of 100 was used 
to account for interspecies extrapolation (10x) and intraspecies 
variability (10x).
    2. Short- and intermediate-term toxicity. Short- and intermediate-
term dermal and inhalation NOAELs are derived by route-to-route 
extrapolation of the oral NOAEL of 0.25 mg/kg/day based on mydriasis 
after 1 week of dosing in a 1-year dog study. Dermal absorption is 
considered to be 1% based on a monkey study that found dermal 
absorption to be less than 1% (rounded up to 1% for analysis purposes). 
Oral and inhalation absorption are both assumed to be 100%.
    3. Chronic toxicity. EPA has established the RfD for avermectin 
B1 and its delta-8,9-isomer at 0.0012 mg/kg/day. This 
Reference Dose (RfD) is based on a 2-generation reproduction study in 
rats. The developmental NOAEL is 0.12 mg/kg/day, and the developmental 
LOAEL is 0.40 mg/kg/day based on decreased pup body weight and 
viability during lactation, and increased incidence of retinal rosettes 
in F2b weanlings. An uncertainty factor of 100 was used to account for 
interspecies extrapolation (10x) and intraspecies variability(10x).
    The long-term dermal NOAEL is a route-to-route extrapolation of the 
oral NOAEL of 0.12 mg/kg/day based on decreased pup body weight and 
viability during lactation, and increased incidence of retinal rosettes 
in F2b weanlings in a 2-generation reproduction study in rats. Dermal 
absorption is considered to be 1% based on a monkey study that found 
dermal absorption to be less than 1% (rounded up to 1% for analysis 
purposes).
    The long-term inhalation NOAEL is a route-to-route extrapolation 
from the oral NOAEL of 0.12 mg/kg/day based on decreased pup body 
weight and viability during lactation, and increased incidence of 
retinal rosettes in F2b weanlings in a 2-generation reproduction study 
in rats. Oral and inhalation absorption are both assumed to be 100%.
    4. Carcinogenicity. The Agency has classified avermectin 
B1 as a Cancer Group E chemical based on the absence of 
significant tumor increases in two adequate rodent carcinogenicity 
studies.

C. Exposures and Risks

    1. From food and feed uses. Tolerances have been established (40 
CFR 180.449) for the combined residues of the insecticide avermectin 
B1 (a mixture of avermectins containing greater than or 
equal to 80% avermectin B1a (5-O-demethyl avermectin 
A1) and less than or equal to 20% avermectin B1b 
(5-O-demethyl-25-de(1-methylpropyl)-25-(1-methylethyl) avermectin 
A1)) and its delta-8,9-isomer, in or on a variety of raw 
agricultural commodities. Permanent tolerances include almonds (0.005 
ppm); almonds, hulls (0.10 ppm); apples (0.020 ppm); apples, wet pomace 
(0.10 ppm); celery

[[Page 48552]]

(0.05 ppm); cucurbits (0.005 ppm); head lettuce (0.05 ppm); pears (0.02 
ppm) bell peppers (0.01 ppm) strawberry (0.02 ppm); fresh tomatoes 
(0.01 ppm); walnuts (0.005 ppm). The following time limited tolerances 
are due to expire September 1, 1999: cattle, fat (0.015 ppm); cattle, 
meat (0.02 ppm); cattle, meat by products (0.02 ppm); citrus, dried 
pulp (0.10 ppm); citrus, oil (0.10 ppm); citrus, whole fruit (0.02 ppm) 
cotton seed (0.005 ppm); dried hops (0.2 ppm); milk (0.005 ppm); 
potatoes (0.005 ppm). The following Section 18 time limited tolerances 
will expire January 31, 2,000: basil (0.05 ppm); celeriac (0.05 ppm) 
spinach (0.05 ppm). Finally, a section 18 time limited tolerance for 
avocado (0.02 ppm) will expire September 20, 2,000. All of these 
tolerances (i.e. both permanent and time-limited) were included in the 
dietary risk analysis. Risk assessments were conducted by EPA to assess 
dietary exposures from avermectin B1 and its delta-8,9-
isomer as follows:
    Section 408(b)(2)(E) authorizes EPA to use available data and 
information on the anticipated residue levels of pesticide residues in 
food and the actual levels of pesticide chemicals that have been 
measured in food. If EPA relies on such information, EPA must require 
that data be provided 5 years after the tolerance is established, 
modified, or left in effect, demonstrating that the levels in food are 
not above the levels anticipated. Following the initial data 
submission, EPA is authorized to require similar data on a time frame 
it deems appropriate. As required by section 408(b)(2)(E), EPA will 
issue a data call-in for information relating to anticipated residues 
to be submitted no later than 5 years from the date of issuance of this 
tolerance.
    Section 408(b)(2)(F) states that the Agency may use data on the 
actual percent of crop treated (PCT) for assessing chronic dietary risk 
only if the Agency can make the following three findings: (1) That the 
data used are reliable and provide a valid basis to show what 
percentage of the food derived from such crop is likely to contain such 
pesticide residue; (2) that the exposure estimate does not 
underestimate exposure for any significant subpopulation group; and (3) 
if data are available on pesticide use and food consumption in a 
particular area, the exposure estimate does not understate exposure for 
the population in such area. In addition, the Agency must provide for 
periodic evaluation of any estimates used. To provide for the periodic 
evaluation of the estimate of percent of crop treated as required by 
the section 408(b)(2)(F), EPA may require registrants to submit data on 
PCT.
    The Agency used the following information to conduct a dietary 
exposure analysis. The maximum PCT is used for acute dietary exposure 
estimates and represents the highest levels to which an individual 
could be exposed. It is unlikely to underestimate an individual's acute 
dietary exposure. The weighted average percent crop treated is used for 
chronic dietary exposure and reasonably represents a person's dietary 
exposure over a lifetime. It is unlikely to underestimate exposure to 
an individual because of the fact that pesticide use patterns (both 
regionally and nationally) tend to change continuously over time, so 
that an individual is unlikely to be exposed to more than the average 
percent crop treated over a lifetime. For each crop in the dietary 
(food only) model the following percent crop treated values were used 
for the acute and chronic analyses (respectively): almond 100%, 100%; 
apple 6.1%, 1.9%; avocado 100%, 100%; basil 100%, 100%; cantaloupe 5%, 
1.3%; celeriac 100%, 100%; celery 60%, 49%; citrus, other 43%, 32%; 
cotton 4.8%, 3.2%; cucumber 100%, 31%; grapefruit, juice and peel 
60.9%, 46%; grapefruit, peeled fruit 43%, 46%; grape 14%, 14%; hops 
100%, 84%; lemon, juice and peel 34.4%, 17%; lemon, peeled fruit 43%, 
17%; head lettuce 28%, 22%; lime, juice and peel 63.2%, 32%; lime, 
peeled fruit 43%, 32%; melons 5%, 1.3%; orange, juice and peel 36.3%, 
28%; orange, peeled fruit 43%, 28%; pear 75%, 56%; peppers 15%, 6.3%; 
potato 5%, 0.3%; spinach 18%, 8.9%; squash 100%, 31%; strawberry 47%, 
42%; tangelo 43%, 57%; tangerine, juice 74.3%, 53%; tangerine, fresh 
43%, 53%; tomato 8%, 3.7%; walnut 100%, 100%; watermelon 5%, 1.3%. For 
fresh, peeled citrus a weighted average (43%) was calculated pooling 
all types of citrus; this value was used in the analysis of chronic 
dietary exposure from citrus.
    The Agency believes that the three conditions, discussed in section 
408 (b)(2)(F) in this unit concerning the Agency's responsibilities in 
assessing chronic dietary risk findings, have been met. With respect to 
condition 1, EPA finds that the PCT information is reliable and has a 
valid basis. The Agency has utilized statistical data from a number of 
public and proprietary sources including USDA/National Agricultural 
Statistics Service, Doane, Maritz, Kline, and National Center for Food 
and Agricultural Policy. However, since the risk assessment includes 
forecast estimates of usage of avermectin B1 on the new 
crops being added, the petitioner must seek permission from the Agency 
to expand usage beyond these estimates (specifically, 14% crop treated 
for grapes, 15% crop treated for peppers). Before the petitioner can 
increase production of product for treatment of greater than 115,500 
acres for grapes (14% of 825,000 total U.S. acres grown) or 17,850 
acres for peppers (15% of 119,000 total U.S. acres grown), permission 
from the Agency must be obtained. With respect to conditions 2 and 3, 
the regional consumption information and consumption information for 
significant subpopulations is taken into account through EPA's 
computer-based model for evaluating the exposure of significant 
subpopulations including several regional groups. Use of this 
consumption information in EPA's risk assessment process ensures that 
EPA's exposure estimate does not understate exposure for any 
significant subpopulation group and allows the Agency to be reasonably 
certain that no regional population is exposed to residue levels higher 
than those estimated by the Agency. Other than the data available 
through national food consumption surveys, EPA does not have available 
information on the consumption of food bearing avermectin B1 
and its delta-8,9-isomer in a particular area.
    i. Acute exposure and risk. Acute dietary risk assessments are 
performed for a food-use pesticide if a toxicological study has 
indicated the possibility of an effect of concern occurring as a result 
of a 1-day or single exposure. The registrant has submitted an acute 
dietary exposure assessment using probabilistic ``Monte Carlo'' 
modeling incorporating anticipated residue and percent of crop treated 
refinements to calculate the Anticipated Residue Contribution (ARC). 
EPA has examined the assumptions made in conducting the analysis for 
the following crops: celery, strawberry, citrus, tomato, and pear, 
apple, grape, and pepper. EPA found the analysis adequate with the 
exception of the acute RfD; the analysis was not conducted with the 
current acute population adjusted dose (PAD) of 0.00025 mg/kg/day. 
Residue Data Files (RDF) and percent crop treated were used on all but 
a few low consumption food items. Reduction factors for fractionation 
and processing were utilized for citrus and pome fruit. Monitoring data 
were not used for mixed/blended commodities.
    EPA was able to further refine the acute dietary estimate from food 
by using updated PCT data, resetting the processing factor for dried 
potatoes to 1 which reflects the non-concentration of

[[Page 48553]]

avermectin B1 in potato processed commodities, correcting 
the residue files above to use one half the level of detection or one 
half the level of quantification, where appropriate, and using the 
average field trial residue level and previously established processing 
factors for blended commodities. In addition, the analysis included 
residues in pear juice for which no data has been previously required. 
Since all other juices show reductions in avermectin B1 
residues from the raw agricultural commodity, EPA will use the 
reduction factor for apples in the analysis. Some of the resulting 
high-end exposure estimates are listed below.
    The resulting calculations are presented below as a percent of the 
acute population adjusted dose (%PAD). The PAD is the reference dose 
(acute or chronic) adjusted for (divided by) the FQPA safety factor. 
EPA is generally concerned with acute exposures that exceed 100% of the 
acute RfD/PAD. The risk estimate should be viewed as highly refined. 
Additional refinement of the almond, basil, cotton seed, hops and 
walnut residue estimates using RDF's and PCT would be unlikely to 
reduce risk estimates significantly. In making a safety determination 
for this tolerance, EPA is taking into account this refined acute 
exposure assessment.

Table 1.-- Acute Dietary (Food Only) Risk for Selected Population Groups
------------------------------------------------------------------------
                                                        ARC (mg/    PAD
                       Subgroup                            kg)      (%)
------------------------------------------------------------------------
U.S. Population.......................................  0.000088       4
All infants (< 1 yr.).................................  0.000111      44
Nursing infants (< 1 yr.).............................  0.000112      45
Non-nursing infants (< 1 yr.).........................  0.000117      47
Children (1-6 yrs.)...................................  0.000176      70
Children (7-12 yrs.)..................................   0.00008      34
                                                        5
Females (13+ yrs. pregnant, non-nursing)..............  0.000054      22
Females (13+ yrs. nursing)............................  0.000093      37
Females (13-19 yrs. non-pregnant, non-nursing)........  0.000061      24
Females (13-50 yrs.)..................................  0.000070      28
Males (13-19 yrs.)....................................  0.000051       2
------------------------------------------------------------------------

    ii. Chronic exposure and risk. In conducting this chronic dietary 
(food only) risk assessment, EPA used anticipated residues and percent 
crop-treated data for many crops. This chronic dietary (food only) 
exposure should be viewed as a highly refined risk estimate; further 
refinement using additional percent crop-treated values would not 
result in a significantly lower dietary exposure estimate. Thus, in 
making a safety determination for this tolerance, EPA is taking into 
account this refined chronic exposure assessment. EPA is generally 
concerned with exposures that exceed 100% of the chronic RfD/PAD. The 
existing avermectin B1 tolerances result in an ARC that is 
equivalent to the following percentages of the RfD or PAD depending on 
the subpopulation:

   Table 2.--Chronic Dietary (Food Only) Risk for Selected Population
                                 Groups
------------------------------------------------------------------------
                                                         ARCFOOD    PAD
                       Subgroup                          (mg/kg)    (%)
------------------------------------------------------------------------
U.S. Population.......................................  0.000008     < 1
U.S. Population - autumn season.......................  0.000008       7
Northeast region......................................  0.000008       7
Western region........................................  0.000009       7
Pacific region........................................  0.000009       7
Non-hispanic other....................................  0.000008       7
All infants (< 1 yr.).................................  0.000016      14
Nursing infants (< 1 yr.).............................  0.000009       7
Non-nursing infants (< 1 yr.).........................  0.000020      17
Children (1-6 yrs.)...................................  0.000016      13
Children (7-12 yrs.)..................................  0.000010       8
Females (13+ yrs. nursing.............................  0.000008       6
Males (20+ years).....................................  0.000007      <1
------------------------------------------------------------------------

    The subgroups listed above are: (1) the U.S. population (48 
states); (2) those for infants, children, females 13+, nursing; (3) the 
other subgroups for which the percentage of the RfD/PAD occupied is 
greater than that occupied by the subgroup U.S. population; and (4) 
other subgroups of regulatory interest.
    2. From drinking water. Avermectin B1 is moderately 
persistent and non-mobile. It is not expected to reach surface or 
ground water in significant quantities. It is stable to hydrolysis at 
pH 5, 7, and 9. It is also moderately persistent in aerobic soil 
(topsoil) with half-lives of 37-131 days. The major pathways of 
avermectin B1 dissipation are binding to soil and sediment, 
degradation in aerobic soil, and photolysis in water. In shallow, well-
mixed surface water with no suspended sediments, avermectin 
B1 degraded rapidly with a photodegradation half-life of 3 
days. However, in most surface waters, suspended sediments and lack of 
mixing would decrease the rate of photodegradation significantly. In 
water, avermectin B1 residues would be tightly bound to 
sediment, reducing aqueous concentrations. There are no Maximum 
Contaminant Levels (MCL) or Health Advisories (HA) established for 
avermectin B1 residues in drinking water.
    To calculate exposure and risk from avermectin B1 in 
drinking water, the EPA analysis first used screening models to 
calculate Estimated Environmental Concentrations (EECs) for groundwater 
(screening concentration in ground water (SCI-GROW2)) and surface water 
(generic expected environmental concentration (GENEEC)). A refined 
model (Pesticide Root Zone Model-EXAMS (PRZM-EXAMS)) was then run on 
surface water (refined models do not exist for ground water but given 
the screening results it is unlikely that the EECs for ground water 
would change significantly). The resulting EECs were then compared to 
the Drinking Water Level of Concern (DWLOC) for various population 
groups to determine acute and chronic risk.
    The screening model SCI-GROW2 was used to calculate EECs for 
avermectin B1 in ground water from use in grapes, peppers, 
and strawberries. Strawberries were analyzed since they represent the 
highest avermectin B1 use rate for any crop. These EECs were 
0.0015, 0.0015, and .002 g/L for grapes, peppers, and 
strawberries, respectively.
    PRZM-EXAMS was used to perform a refined assessment of EECs for 
avermectin B1 in surface drinking water. Use sites modeled 
were grapes grown with grassed middles in New York and strawberries 
grown on black plastic mulch in Florida. Peppers were not modeled 
because the application rate is lower than that for strawberries. Crop 
specific consecutive PRZM-EXAMS simulations were conducted to evaluate 
the cumulative probability distribution for peak, 4-day, 21-day, 60-
day, and 90-day EECs. PRZM-EXAMS EECs for avermectin B1 were 
0.18 and 0.88 g/L for peak values and 0.16 and 0.57 
g/L for 90-day for grape and strawberries, respectively.
    EPA decided to rely on the strawberry model to assess aggregate 
risk since strawberries were considered a higher exposure scenario 
(four applications per season allowed for strawberries vs. three 
applications for peppers or two applications for grapes). However, EPA 
noted that the certainty of the concentrations estimated for 
strawberries is low, due to uncertainty on the amount of runoff from 
plant beds covered in plastic mulch and uncertainty on the amount of 
degradation of avermectin B1 on black plastic compared to 
soil. In order to refine the model in the future, the Agency will 
require the registrant, as a condition of product registration, to 
conduct additional tests on the effects of plastic mulch on surface 
water pesticide concentrations.

[[Page 48554]]

    A Drinking Water Level of Comparison (DWLOC) is a theoretical upper 
limit of a pesticide's concentration in drinking water in light of 
total aggregate exposure to that pesticide in food and through 
residential uses. A DWLOC will vary depending on the toxic endpoint, 
consumption, and body weight. Different populations will have different 
DWLOCs. EPA uses DWLOCs internally in the risk assessment process as a 
surrogate measure of potential exposure associated with pesticide 
exposure through drinking water. In the absence of monitoring data for 
pesticides, the DWLOC is used as a point of comparison against 
conservative model estimates of potential pesticide concentration in 
water. DWLOC values are not regulatory standards for drinking water.
     Acute and chronic exposure and risk. No monitoring data of ground 
water and surface water are available for avermectin B1. The 
SCI-GROW2 modeling data for the grape and chili pepper uses resulted in 
maximum concentrations in ground water of 0.0015 g/L for both 
acute and chronic exposure. Refinements using PRZM-EXAMS indicate a 
peak EEC in surface water at 0.88 g/L and a 90-day EEC at 0.57 
g/L. The modeling data were compared to the results of the 
following equations used to calculate acute and chronic DWLOC for 
avermectin B1 in ground and surface water. Additionally, as 
a result of the retention of the FQPA Safety Factor, EPA considered the 
PAD for females 13+, infants, and children to be 0.00025 and 0.00012 
mg/kg/day for acute and chronic exposure, respectively. For all other 
populations (e.g. U.S. population, Hispanics, adult males), exposures 
will be compared to the acute and chronic PADs, 0.0025 and 0.0012 mg/
kg/day, respectively.
    DWLOC's are calculated as follows: Acute = (acuteRfD/10) - (acute 
food (mg/kg/day))  x  (bodyweight) / consumption (L)  x  
10-3 mg/g. Chronic = (RfD/10) - (chronic food (mg/
kg/day))  x  (bodyweight)/consumption (L)  x  10-3 mg/
g. The 2 liters (L) of drinking water consumed/day by adults 
and the 1 L per day consumed by children are default assumptions used 
by the EPA. The Agency's default body weights for the U.S. population 
and males is 70 kg and for females, 60 kg. EPA's default body weight 
for children is 10 kg. There are no chronic residential exposures to 
avermectin B1.
    The results indicate that the exposure to avermectin B1 
in drinking water derived from ground water using SCI-GROW modeling 
data are below the calculated DWLOC for all population subgroups of 
concern from use of avermectin B1 in grapes, peppers and 
strawberries. Exposure to avermectin B1 in drinking water 
derived from surface water using the refined estimates from PRZM-EXAMS 
and using the results for the crop with the highest use rate 
(strawberries) the modeled exposure data are below the calculated DWLOC 
for all population subgroups of concern except for the acute exposure 
for children 1-6 yrs where the modeled exposure concentration slightly 
exceeds the DWLOC (0.88 vs. 0.74 g/L).
    Despite this slight exceedance, EPA believes that acute exposure to 
avermectin from drinking water will not pose an unacceptable risk to 
human health. Neither surface nor ground water models used by EPA were 
designed specifically for estimating concentrations in drinking water. 
There are significant uncertainties in both the toxicology used to 
derive the DWLOC and the exposure estimate from the PRZM-EXAMS model. 
EPA has compensated for these uncertainties by using reasonable high-
end assumptions. Given this approach, the Agency does not attach great 
significance to such a small difference. However, EPA may do additional 
analyses and, as a condition of product registration, the Agency will 
require the registrant to submit (1) data on the effects of plastic 
mulch on surface water pesticide concentrations and (2) data 
characterizing the effectiveness of various types of drinking water 
treatment on removing avermectin. These data are expected to confirm 
that the actual concentration of avermectin in drinking water is less 
than the level of concern for all sub-populations.
    3. From non-dietary exposure. Avermectin B1 and its 
delta-8,9-isomer is currently registered for use on the following 
residential non-food sites: residential lawns for fire ant control, and 
residential indoor crack & crevice for cockroaches. Registered 
residential uses may result in short-term to intermediate exposures. 
However, based on current use patterns, chronic exposure (6 or more 
months of continuous exposure) to avermectin B1 is not 
expected.
    i. Short and intermediate exposure and risk--residential lawn 
applications. For exposure of residential applicators, three scenarios 
used were: (a) granular bait dispersed by hand, (b) belly grinder-
granular open pour-mixer/loader/applicator (MLAP) and (c) push type 
granular MLAP. Short- and Intermediate-term total MOEs (dermal + 
inhalation) are greater than 1,000 and therefore do not exceed EPA's 
level of concern.
    For postapplication exposure from treated lawns, EPA default 
assumptions such as dermal transfer coefficient (Tc), exposure time 
(ET), hand surface area (SA), ingestion frequency (FQ), residue 
dissipation, and ingestion rates were used. These defaults were used to 
estimate postapplication exposure to children and adults from treated 
lawns. The application rate (AR) used for this assessment is based on 
the label for Affirm Fire Ant Insecticide (0.011% avermectin 
B1). The label recommends a broadcast application rate on 
lawns of 1 lb of product/acre (1.1E-4 lb ai/acre). This is maximum rate 
for all registered lawn uses. A margin of exposure (MOE) of 1,000 or 
greater is required for the most sensitive subgroups. All lawn 
postapplication MOEs exceeded this value and are therefore not of 
concern. The dermal short- and intermediate-term MOEs for adults and 
children are 83,000 and 86,000, respectively. The oral hand-to-mouth 
short- and intermediate-term MOEs for children are 14,000 and 6,500, 
respectively. The oral incidental ingestion short- and intermediate-
term MOEs for children are 610,000 and 290,000, respectively.
    ii. Short and intermediate exposure and risk--residential indoor 
crack and crevice uses. For residential applicators, exposure and risk 
estimates for homeowners applying crack and crevice baits were 
estimated using the EPA DRAFT Standard Operating Procedure (SOP) for 
Residential Exposure Assessments (12/18/97).
    The amount of active ingredient (ai) handled was based on the 
assumption that one 30 gram package of Whitmire Avert Prescription Bait 
Prescription Treatment 310 (0.05% ai) would be applied in a day. The 
unit exposure from the EPA default wettable powder, open mixing and 
loading scenarios was used as a surrogate for estimating dermal and 
inhalation exposure to residential applicators. The short- and 
intermediate-term MOEs for dermal and inhalation exposure are each 12 
million, which does not exceed EPA's level of concern.
    For estimating postapplication exposure and risk from indoor 
treatment, two postapplication exposure studies were conducted with 
crack and crevice products containing avermectin B1: (1) 
Evaluation of Avert Prescription Treatment 310 Residual Study in Air, 
Food and on Surfaces, dated November 8, 1990 and (2) Evaluation of 
Indoor Exposure to a Crack and Crevice Application of Whitmire Avert 
Crack and Crevice Prescription Treatment 310 and Prescription TC 93A 
Bait, dated October 27, 1995. The 1990 study reported measured 
avermectin B1

[[Page 48555]]

concentrations in wipe and air samples up to 7 days following the 
application. The 1995 study reported non-detect values for all air and 
surface residue (cotton cloth dosimeters) samples taken.
    The EPA noted that neither study met 100% of the Pesticide 
Assessment Guideline criteria. Among other shortcomings, the 1990 study 
did not report the amount of avermectin B1 applied. However, 
subsequent documentation provided by the study director stated that the 
application rate in the 1990 study was at least three times greater 
than the normal label rate.
    To be conservative, EPA decided that the values from the 1990 study 
would be used for this risk assessment. EPA default assumptions for 
dermal Tc, ET, SA, FQ, inhalation rates, and ingestion rates were used. 
These defaults were used to estimate children's postapplication 
exposure to the product Avert Prescription Treatment 310 (dry flowable 
cockroach bait). According to Table A-1 of the SOP's for Residential 
Exposure Assessments, the method used for estimating children's 
postapplication exposure is believed to produce a central to high-end 
estimate of exposure.
    Based on the information available on the study, the air and 
surface residue values taken from the 1990 study were divided by a 
factor of 3 to account for the exaggerated application rate used in the 
study. The avermectin B1 residue value reported for 
horizontal residues immediately after the application (4.2E-07 mg/
cm2) was divided by a factor of 3 (1.4E-6 mg/cm 2) and then 
used to estimate children's dermal and hand-to-mouth exposure. A linear 
regression analysis was performed on the reported air concentrations at 
0 (immediately after), 1, 3 and 7 days after the application to 
determine the average concentration for the first 21 hours following 
the application. The analysis indicated an average concentration of 
avermectin B1 at 6.4E-04 mg/m3 (4% dissipation, 
adjusted R2 = 0.986 for log-transformed data). This value was divided 
by a factor of 3 (2.1E-4 mg/m3) and then used to estimate 
children's inhalation exposure.
    The Short- and intermediate-term dermal MOE for children's 
postapplication dermal is 78,000. The short- and intermediate-term oral 
MOE for children's postapplication oral hand-to-mouth is 12,000. The 
short- and intermediate-term inhalation MOE for children's 
postapplication inhalation is 2,400.
    The risk from children's post application exposure to crack and 
crevice products containing avermectin B1 does not exceed 
EPA's level of concern. Avert Prescription Treatment 310 is a dust 
formulation that is intended for the application to crack and crevices 
only. Other formulations for similar crack and crevice products (i.e., 
gels, granulars, pressurized liquids, etc.) will have less migration 
from the treated area and are expected to result in lower risk from 
dermal, oral, and inhalation postapplication exposure.
    4. Cumulative exposure to substances with common mechanism of 
toxicity. Section 408(b)(2)(D)(v) requires that, when considering 
whether to establish, modify, or revoke a tolerance, 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 does not have, at this time, available data to determine 
whether avermectin B1 and its delta-8,9-isomer has a common 
mechanism of toxicity with other substances or how to include this 
pesticide in a cumulative risk assessment. Unlike other pesticides for 
which EPA has followed a cumulative risk approach based on a common 
mechanism of toxicity, avermectin B1 and its delta-8,9-
isomer does not appear to produce a toxic metabolite produced by other 
substances. For the purposes of this tolerance action, therefore, EPA 
has not assumed that avermectin B1 and its delta-8,9-isomer 
has a common mechanism of toxicity with other substances. For 
information regarding EPA's efforts to determine which chemicals have a 
common mechanism of toxicity and to evaluate the cumulative effects of 
such chemicals, see the final rule for Bifenthrin Pesticide Tolerances 
(62 FR 62961, November 26, 1997).

D. Aggregate Risks and Determination of Safety for U.S. Population 
including Infants and Children

    In examining aggregate exposures, FQPA directs EPA to consider 
available information concerning exposures from the residue in food and 
all other non-occupational exposures. The primary non-food sources of 
exposure the Agency looks at include drinking water (whether from 
ground or surface water), and exposure through pesticide use in 
gardens, lawns or buildings (residential and other indoor and/or 
outdoor uses). In evaluating food exposures, EPA takes into account 
varying consumption patterns of major identifiable subgroups of 
consumers, including infants and children.
    1. Acute risk. Acute aggregate exposure takes into account acute 
dietary food and water exposure. The registrant submitted an acute 
dietary exposure analysis using probabilistic ``Monte Carlo'' modeling. 
EPA has examined the assumptions made in conducting the analysis and 
has recalculated the assessment using the submitted acute file, the 
correct acute RfD, updated PCT data, correcting the residue files above 
to use one half the Level of Detection (LOD) or one half the Level of 
Quantitation (LOQ) where appropriate, and using the average field trial 
residue level and previously established processing factors for blended 
commodities. In addition, EPA's analysis included residues in pear 
juice for which no data has been previously required. Since all other 
juices show reductions in avermectin B1 residues from the 
raw agricultural commodity, EPA used the reduction factor for apples in 
the analysis. The dietary (food only) acute %PAD range from 45% for 
nursing infants < 1 year old to 70% for children 1-6 yrs. This risk 
estimate should be viewed as highly refined since it used anticipated 
residue values and percent crop-treated data in conjunction with Monte 
Carlo analysis. The acute dietary exposure does not exceed EPA's level 
of concern.
    Avermectin B1 is a moderately persistent but non-mobile 
compound in soil and water environments. The SCI-GROW modeling data for 
avermectin B1 for drinking water derived from ground water 
sources resulting from use on grapes and peppers indicate levels less 
than OPP's DWLOC for acute exposure. Using the refined PRZM-EXAMS 
modeling data for drinking water derived from surface water sources 
resulting from use on strawberries (the crop with the maximum use rate) 
also indicates levels less than OPP's DWLOC for acute exposure in all 
populations with the exception of children 1-6 years old where the peak 
EEC of 0.88 g/L slightly exceed this subgroup's acute DWLOC 
(0.74 g/L).
    Despite this slight exceedance, EPA believes that acute exposure to 
avermectin from drinking water will not pose an unacceptable risk to 
human health. Neither surface nor ground water models used by EPA were 
designed specifically for estimating concentrations in drinking water. 
There are significant uncertainties in both the toxicology used to 
derive the DWLOC and the exposure estimate from the PRZM-EXAMS model. 
EPA has compensated for these uncertainties by using reasonable high-
end assumptions. Given this approach, the Agency does not attach great 
significance to such a small difference. However, EPA may do additional 
analyses and, as a condition of product registration, the Agency will 
require the registrant to submit (1) data

[[Page 48556]]

on the effects of plastic mulch on surface water pesticide 
concentrations and (2) data characterizing the effectiveness of various 
types of drinking water treatment on removing avermectin. These data 
are expected to confirm that the actual concentration of avermectin in 
drinking water is less than the level of concern for all sub-
populations.
    2. Chronic risk. Chronic aggregate exposure takes into account 
chronic exposure via food, water, and residential uses. Since there is 
no chronic residential exposure to avermectin B1 only food 
and water contributed to chronic risk.
    Using the exposure assumptions described in this notice, EPA has 
concluded that aggregate exposure to avermectin B1 and its 
delta-8,9-isomer from food will utilize < 1% of the PAD for the U.S. 
population and will utilize from 6% to 17% of the PAD for infants and 
children (depending on specific subgroup). The major identifiable 
subgroup with the highest aggregate exposure is non-nursing infants 
with 17% of the chronic PAD. EPA generally has no concern for exposures 
below 100% of the RfD/PAD because the RfD/PAD represents the level at 
or below which daily aggregate dietary exposure over a lifetime will 
not pose appreciable risks to human health.
    Avermectin B1 is a moderately persistent, but non-mobile 
compound in soil and water environments. The modeling data for 
avermectin B1 indicate chronic water residue levels less 
than OPP's DWLOC's. EPA does not expect aggregate chronic exposure to 
avermectin B1 will pose an unacceptable risk to human 
health.
    3.  Short- and intermediate-term risk. Short-term aggregate 
exposure takes into account chronic dietary food and water (considered 
to be a background exposure level) plus short-term residential uses 
which include dermal, inhalation, and oral exposures. For children's 
post-application exposure from crack and crevice uses, the worst case 
exposure scenario, risks do not exceed EPA's level of concern. The 
residential uses that were aggregated with chronic dietary food and 
water are from lawn and crack and crevice uses and include: (1) Adult 
dermal exposure from the highest adult residential applicator scenario 
(3.4E-7 mg/kg/day from belly grinder granular open pour) and crack and 
crevice applicator scenario (2.1E-8 mg/kg/day) with exposure from post-
application activities (3.0E-6 mg/kg/day), and inhalation from turf and 
crack and crevice (3.9E-7 mg/kg/day). (2) Children's oral exposure from 
turf and crack and crevice hand-to-mouth, with turf incidental 
ingestion (3.8E-5 mg/kg/day), dermal exposure from turf and crack and 
crevice (6.1E-6 mg/kg/day), and inhalation exposure from crack and 
crevice (1.1E-4 mg/kg/day).
    Using the exposures above, EPA calculated the short-term DWLOCs. 
The DWLOC of 8.2 g/L for the U.S. population is greater than 
the water EEC's. The DWLOC for infants/children (0.77 g/L) is 
greater than the PRZM-EXAMS chronic value of 0.57 g/L. EPA 
does not expect aggregate short-term exposure to avermectin 
B1 will pose an unacceptable risk to human health.
    The worst case intermediate-term exposures to avermectin 
B1 for adults are the same as those described above for 
short-term exposures. Using the exposures above, EPA calculated the 
adult intermediate-term DWLOC of 8.2 g/L, which is greater 
than the water EEC's. EPA does not expect aggregate intermediate-term 
exposure to avermectin B1 will pose an unacceptable risk to 
adult human health.
    The worst case intermediate-term exposures to avermectin 
B1 for infants and children are the same as those described 
above. Since the short- and intermediate-term NOAELs are the same, the 
DWLOC is also equal to the 0.77 g/L short-term value. Again, 
given the 0.57 g/L PRZM-EXAMS value, EPA is not concerned with 
the residues in drinking water. EPA does not expect aggregate 
intermediate-term exposure to avermectin B1 will pose an 
unacceptable risk to human health.
    4. Aggregate cancer risk for U.S. population. EPA classified 
avermectin B1 as a Cancer Group E chemical based on the 
absence of significant tumor increases in two adequate rodent 
carcinogenicity studies.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the U.S. population, infants, or children from aggregate exposure to 
avermectin B1 and its delta-8,9-isomer residues.

E. Determination of Safety for Infants and Children

    1. In general. In assessing the potential for additional 
sensitivity of infants and children to residues of avermectin 
B1 and its delta-8,9-isomer, EPA considered data from 
developmental toxicity studies in the rat and rabbit and a 2-generation 
reproduction study in the rat. The developmental toxicity studies are 
designed to evaluate adverse effects on the developing organism 
resulting from maternal pesticide exposure gestation. Reproduction 
studies provide information relating to effects from exposure to the 
pesticide on the reproductive capability of mating animals and data on 
systemic toxicity.
    FFDCA section 408 provides that EPA shall apply an additional 
tenfold margin of safety for infants and children in the case of 
threshold effects to account for pre- and postnatal toxicity and the 
completeness of the database unless EPA determines that a different 
margin of safety will be safe for infants and children. Margins of 
safety are incorporated into EPA risk assessments either directly 
through use of a margin of exposure (MOE) analysis or through using 
uncertainty (safety) factors in calculating a dose level that poses no 
appreciable risk to humans. EPA believes that reliable data support 
using the standard uncertainty factor (usually 100 for combined inter- 
and intra-species variability) and not the additional tenfold MOE/
uncertainty factor when EPA has a complete data base under existing 
guidelines and when the severity of the effect in infants or children 
or the potency or unusual toxic properties of a compound do not raise 
concerns regarding the adequacy of the standard MOE/safety factor.
     2. Developmental toxicity studies.  Studies are discussed in Unit 
III.A.4 of this preamble.
     3. Reproductive toxicity study. Studies are discussed in Unit 
III.A.4 of this preamble.
     4. Pre- and postnatal sensitivity. There was evidence of increased 
susceptibility to the offspring following pre- and postnatal exposure 
to avermectin B1 in the 2-generation reproduction study in 
rats.
     5. Conclusion. There is a complete toxicity database for 
avermectin B1 and its delta-8,9-isomer and exposure data is 
complete or is estimated based on data that reasonably accounts for 
potential exposures. The Agency is retaining the 10-fold safety factor 
for increased susceptibility of infants and children for this pesticide 
and is applying it to females 13+, infants, and children population 
subgroups for acute, chronic, and residential exposure.
     The 10x Safety Factor is being retained because:
    (1) There was evidence of increased susceptibility to the offspring 
following pre- and postnatal exposure to avermectin B1 in 
the two-generation reproduction study in rats.
    (2) There is evidence of neurotoxicity manifested as clinical signs 
of neurotoxicity in mice, rats, and dogs in developmental, 
reproduction, chronic and/or carcinogenicity studies in mice, rats and/
or dogs.

[[Page 48557]]

    (3) There is concern for Structure Activity Relationship: 
ivermectin induced cleft palate in fetal rats, and cleft palate and 
clubbed forefoot in fetal rabbits.
    (4) EPA determined that a developmental neurotoxicity study in rats 
is required for avermectin B1. This study could provide 
additional information on potential increased susceptibility, effects 
on the development of the fetal nervous system, as well as the 
functional development of the young.
    (5) There is concern for post-application exposure to infants and 
children in treated areas, including incidental hand-to-mouth ingestion 
of the pesticide.

IV. Other Considerations

A. Metabolism In Plants and Animals

    Plant metabolism data have been previously submitted on cotton 
seed, citrus, and celery. In addition, a report titled ``Comparative 
Degradation of Avermectin B1a in Cotton Leaf, Citrus Fruit, 
Celery, and In Vitro'' was submitted. The proposed use in this petition 
on grapes and chili peppers specifies multiple applications up to a 
maximum application rate on grapes of 32 fl oz/A/season (0.038 lb ai/A/
season) and on peppers of 48 oz/A/season (0.057 lb ai/A/season). 
Previously, the metabolism components have been examined from radio-
labeled avermectin B1 on celery (10 applications at 7 day 
intervals for a total equivalent of 1.0 lb ai/A/season), radio-labeled 
avermectin B1 on cotton (3 applications at 50 to 89 day 
intervals for a total equivalent of 0.60 lb/A/season), and exaggerated 
application rates to citrus (30X, 2.25 lb ai/A). The available 
metabolism data on cotton, celery, and citrus represent a wide enough 
range of crop matrices, growth modes, and use rates. It is unlikely 
that application of avermectin B1 to grapes and chili 
peppers will result in new degradation compounds that have not 
previously been produced and subjected to toxicity testing. EPA 
concludes that the metabolism data are sufficient (a) to support the 
proposed use on grapes and chili peppers and (b) to support the 
recommended tolerance on cotton gin byproducts. The residues of concern 
in/on grapes, chili pepper, and cotton gin byproduct commodities are 
the parent compound (avermectin B1a and B1b) and 
its delta-8,9-isomer.
    Since there are no grape or chili pepper animal feed items of 
regulatory concern, a discussion of animal metabolism is not germane to 
petition PP 7F4844.
    Animal metabolism data were not submitted in conjunction with 
cotton petition (PP 7F3500). However, the metabolism of avermectin in 
goat and rat has been reviewed. From these studies, it was determined 
that the residues of concern in ruminants are avermectin B1a 
and B1b and their delta-8,9-isomers. This conclusion was 
based upon a feeding level of 1.0 mg/goat/day of 3H-
avermectin. An additional metabolite (24-hydroxymethyl avermectin 
B1a) was identified and is potentially of toxicological 
significance, but was not included in the tolerance expression because 
of its presence at low levels. However, EPA notes that if the livestock 
dietary burden is increased and the tolerances for residues in meat and 
milk need to be raised, then the 24-hydroxymethyl metabolite may need 
to be included in the tolerance expression and appropriate enforcement 
methods would need to be developed. Furthermore, an additional animal 
metabolism study using 14C-avermectin would be needed if the 
expected ruminant dietary burden exceeded the dose level in the 
previously submitted goat metabolism study. EPA concludes the available 
ruminant metabolism study is adequate to support the proposed 
tolerances for avermectin on cotton gin byproducts.
    Cotton gin byproducts are not a poultry feed item. Therefore a 
discussion of metabolism and secondary residues in poultry commodities 
is not pertinent to petition PP 7F3500.

B. Analytical Enforcement Methodology

    The registrant has used the analytical procedure designated Method 
91-1 for data gathering purposes in these grape and chili pepper field 
trials for avermectin B1 and its delta-8,9-isomer. 
Acceptable independent method validations (ILV) were submitted for both 
commodities. The samples are extracted with acetonitrile/water/hexane, 
cleaned up with an aminopropyl column, and derivatized with 
trifluoroacetic anhydride. Quantitation of the residues of interest is 
accomplished by high performance liquid chromatography (HPLC) with 
fluorescence detector. The LOQ varies from .001 ppm for grapes to .004 
ppm for chili peppers. Method 91-1 is adequate for data collection 
purposes. Method 91-1 is somewhat similar to the registrant's method 
for hops, Method M-036.2, which has been submitted for inclusion in 
FDA's PAM II. Since they are similar, Method M-036.2 is adequate for 
tolerance enforcement.
    Residues of avermectin B1 and 8,9-Z avermectin 
B1 in cotton gin byproducts were determined using a 
modification of Method M-078. Samples are extracted with a methanol-
water mixture. The avermectins are partitioned into hexane and the 
hexane extract is purified/concentrated on an NH2 SPE column. The 
purified extract is derivatized with trifluoroacetic anhydride. The 
derivatized avermectins are analyzed by reversed phase HPLC with 
fluorescence detection. The avermectin B1a standard is used 
to calculate the concentration of avermectin B1a + 8,9-Z 
avermectin B1a and avermectin B1b + 8,9-Z 
avermectin B1b in/on the sample. The modifications made to 
Method M-078 included using a higher HPLC flow rate, preparing the 
standard solutions at different concentrations, centrifuging the 
samples with emulsions after shaking, and using equipment, apparatus, 
and chemical manufacturers which were different from those specified in 
the method. The limit of detection (LOD) is 0.001 ppm; the LOQ is 0.002 
ppm. The method was validated by fortifying control gin trash samples 
and analyzing them concurrently with the treated and control samples. 
Method M-078 is very similar to the registrant's method for hops, 
Method M-036.2, which has been submitted for inclusion in FDA's PAM II. 
Since they are very similar and method recovery is good, Method M-078 
is adequate for enforcement purposes.
    Merck Method 32A is available for enforcing avermectin tolerances 
in bovine tissues and milk. This method has been published in PAM II 
(Method II).
    Avermectin B1 is not recovered using FDA multi-residue 
protocol A described in PAM I.

C. Magnitude of Residues

    The residue field trial data on grapes submitted with this petition 
are adequate to support the proposed use. The highest residue found on 
grapes at the 28-day pre-harvest interval (PHI) was 6.7 ppb (0.007 
ppm). This supports the tolerance of 0.02 ppm proposed by the 
registrant.
    The residue field trial data on chili peppers submitted with this 
petition are adequate to support the proposed use. The highest residue 
found on chili peppers at the 7- day PHI was < 5 parts per billion 
(ppb) (< 0.005 ppm). This supports the tolerance of 0.01 ppm on peppers 
proposed by the registrant. However, the originally submitted Section F 
lists chili peppers not peppers. In order to harmonize with 
international residue limits discussed below, the Section F was revised 
to express the tolerance as 0.02 ppm on peppers.

[[Page 48558]]

    The grape processing study and existing storage stability database 
are adequate to support the proposed tolerance on juice. The highest 
residues found on commodities of regulatory concern were < 2 ppb (< 
0.002 ppm) in juice. This supports the requested tolerance of 0.02 ppm 
on grape juice. However, since the processing study shows that 
avermectin B1 does not concentrate in juice, a tolerance on 
grape juice is not required.
    Starting with raw grapes bearing residues of 10 ppb, the highest 
avermectin B1 residues found on raisins were 10.2 ppb (0.01 
ppm). The results of the raisin storage stability study indicate that 
the residues in raisins could have been as high as 20 ppb (2x 
concentration factor, based on < 50% recoveries). Using this 
concentration factor and the highest grape field trial value of 0.007 
ppm, residues in raisins would be 0.014 ppm versus the grape tolerance 
of 0.02 ppm. Therefore, even taking into account the poor recoveries 
from the raisin storage stability study, a tolerance for raisins is not 
necessary. Since tolerances are not needed for processed grape food 
items, the Section F was revised to express the tolerance as grapes.
    There are no chili pepper processed food items; therefore a 
discussion of processed food items is not germane to this action.
    Since there are no grape or pepper animal feed items of regulatory 
interest, secondary avermectin B1 residues in meat, milk, 
poultry, and eggs will not be increased by the proposed tolerances for 
these crops.
    To support the tolerance on cotton gin byproducts, the petitioner 
has submitted the results of eight field trials on cotton using the 
maximum labeled rate. The existing storage stability database is 
adequate to support the cotton gin byproduct analyses. The highest 
residue level obtained was 0.101 ppm. The PHI was slightly longer than 
that specified on the label, however. The label specifies a PHI of 20 
days; the PHI used in the field trails was 25 days. EPA has concluded 
that the data support the establishment of a tolerance of 0.15 ppm for 
the residues of avermectin in/on cotton gin byproducts.
    Since cotton gin byproducts are a feed item for some livestock an 
analysis was performed to calculate the dietary burden in these 
animals. Cotton gin byproducts are not a feed item for poultry or 
swine; these commodities were not included in the analysis. Cotton gin 
byproducts can comprise up to 20% of the diets of both beef and dairy 
cattle. The following animal feed items are associated with commodities 
with avermectin registrations: almond hulls, wet apple pomace, dried 
citrus pulp, cotton seed, potato culls, and potato waste. Of these 
commodities, cotton seed meal is the only highly nutritive one. The 
others mainly provide fiber to the diet. Cotton seed meal will be 
distributed to all parts of the country, but the others will not. 
Therefore, it is reasonable to construct a dietary burden with cotton 
seed meal and only one of the other ``esoteric'' feed items. Wet apple 
pomace would contribute the highest residues to the diet, therefore a 
dietary burden was constructed using cotton seed meal and apple pomace. 
The feeding study was done at 3 different feeding levels: 0.010 ppm, 
0.030 ppm, and 0.10 ppm. The dietary burden constructed with cotton 
seed and apple pomace is essentially the same as the highest feeding 
level: 0.10 ppm. The established tolerances are adequate to cover this 
dietary burden. As the tolerances will not change, it is not necessary 
to perform a dietary exposure analysis. EPA concludes that residues 
present in animal commodities will not increase over current levels. 
Therefore, it is not necessary to increase the established tolerances 
for animal commodities. Furthermore, the establishment of a tolerance 
for cotton gin byproducts does not affect risk to human health as 
animal commodity tolerances will not be affected by the establishment 
of this tolerance.

D. International Residue Limits

    There are no Codex, Canadian, or Mexican Maximum Residue Limits 
(MRL) for avermectin B1 on grapes, grape processed 
commodities. Therefore, international harmonization is not an issue for 
the action on grapes.
    There are no Canadian or Mexican MRLs for avermectin B1 
on peppers. There is a Codex MRL for avermectin B1a, 
B1b, (Z)-8,9-avermectin B1a, and (Z)-8,9-
avermectin B1b on sweet peppers at 0.02 ppm. The regulable 
residues for the U.S. and Codex are identical. In order to harmonize 
with this MRL, the Section F was revised to express the tolerance for 
avermectin B1 and its delta-8.9-isomer as 0.02 ppm on 
peppers.
    There are no Codex, Canadian, or Mexican MRLs for avermectin 
B1 on cotton gin by-products. Therefore, international 
harmonization is not an issue for cotton gin by-products. A Codex MRL 
has been established for cotton seed: 0.01 ppm. This MRL differs from 
the proposed permanent tolerance for cotton seed: 0.005 ppm.

E. Rotational Crop Restrictions 

    Review of the results of the confined rotational crop study 
indicated that avermectin B1 residues accumulated in some 
rotational crops at levels up to 10 - 12 ppb. However, the 
radioactivity was due to polar degradates that were of little 
toxicological concern as compared to the parent compound avermectin 
B1 and/or the delta-8,9-isomer. Therefore, the requirements 
for field rotational crop studies have been waived.

V. Conclusion

    Therefore, the tolerance is established for combined residues of 
the insecticide avermectin B1 (a mixture of avermectins 
containing greater than or equal to 80% avermectin B1a (5-O-
demethyl avermectin A1) and less than or equal to 20% 
avermectin B1b (5-O-demethyl-25-de(1-methylpropyl)-25-(1-
methylethyl) avermectin A1)) and its delta-8,9-isomer in 
grapes at 0.02 ppm, peppers at 0.02 ppm, and cotton gin byproducts at 
0.15 ppm. Furthermore, the following tolerances which were previously 
time-limited (expiring September 1, 1999) are now made permanent: 
cattle, fat at 0.015 ppm; cattle, meat byproducts at 0.02 ppm; cattle, 
meat at 0.02 ppm; citrus, dried pulp at 0.10 ppm; citrus, oil at 0.10 
ppm; citrus, whole fruit at 0.02 ppm; cotton seed at 0.005 ppm; hops, 
dried at 0.20 ppm; milk at 0.005 ppm; and potatoes at 0.005 ppm.

VI. 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 178. To ensure proper receipt by EPA, you must 
identify docket control number OPP-300916 in the subject line

[[Page 48559]]

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 8, 1999.
    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 (1900), 
Environmental Protection Agency, 401 M St. SW. Washington, DC 20460. 
You may also deliver your request to the Office of the Hearing Clerk in 
Room M3708, Waterside Mall, 401 M St. SW. Washington, DC 20460. 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) 260-4865.
    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 be 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.'' (cite). 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, 401 M St. SW., 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, 401 M St. SW. 
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 VI.A. of 
this preamble, you should also send a copy of your request to the PIRB 
for its inclusion in the official record that is described in Unit 
I.B.2. of this preamble. Mail your copies, identified by docket number 
OPP-300916, to: Public Information and Records Integrity Branch, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St. SW. 
Washington, DC 20460. In person or by courier, bring a copy to the 
location of the PRIB described in Unit I.B.2. of this preamble. You may 
also send an electronic copy of your request via e-mail to: opp-
[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 5.1/6.1 file format 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).

VII. Regulatory Assessment Requirements

    This final rule establishes tolerances 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). 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 prior consultation with State, local, and tribal 
government officials as specified by Executive Order 12875, entitled 
Enhancing the Intergovernmental Partnership (58 FR 58093, October 28, 
1993) and Executive Order 13084, entitled Consultation and Coordination 
with Indian Tribal Governments (63 FR 27655, May 19,1998), or special 
consideration of environmental justice related issues 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 require OMB review in accordance with Executive 
Order 13045, entitled Protection of Children from Environmental Health 
Risks and Safety Risks (62 FR 19885, April 23, 1997). 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 12612, 
entitled Federalism (52 FR 41685, October 30, 1987). This action 
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 the Federal Food, Drug, and Cosmetic Act, 
21 U.S.C. section 346a(b)(4). 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). In addition, since 
tolerances and exemptions that are established on the basis of a 
petition under FFDCA section 408(d), such as the tolerances 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.

VIII. 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

[[Page 48560]]

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 rule in the Federal Register. This 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: August 31, 1999.

Richard P. Keigwin, Jr.,

Acting Director, Registration Division, 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), (346a), and 371.


    2. Section 180.449 is amended by revising paragraph (a) to read as 
follows:


Sec. 180.449   Avermectin B1 and its delta-8,9-isomer; 
tolerances for residues.

    (a) General. Tolerances are established for the combined residues 
of the insecticide avermectin B1 (a mixture of avermectins 
containing greater than or equal to 80% avermectin B1a (5-O-
demethyl avermectin A1) and less than or equal to 20% 
avermectin B1b (5-O-demethyl-25-de(1-methylpropyl)-25-(1-
methylethyl) avermectin A1)) and its delta-8,9-isomer in or 
on the following commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Almonds....................................................        0.005
Almond, hulls..............................................         0.10
Apples.....................................................        0.020
Apples, pomace (wet).......................................         0.10
Cattle, fat................................................        0.015
Cattle, mbyp...............................................         0.02
Cattle, meat...............................................         0.02
Celery.....................................................         0.05
Citrus, dried pulp.........................................         0.10
Citrus, oil................................................         0.10
Citrus whole fruit.........................................         0.02
Cotton gin by-products.....................................         0.15
Cotton seed................................................        0.005
Cucurbits (cucumbers, mellons, and squashes)...............        0.005
Grapes.....................................................         0.02
Hops, dried................................................         0.20
Lettuce, head..............................................         0.05
Milk.......................................................        0.005
Pears......................................................         0.02
Peppers....................................................         0.02
Potatoes...................................................        0.005
Strawberry.................................................         0.02
Tomatoes, fresh............................................         0.01
Walnuts....................................................        0.005
------------------------------------------------------------------------

* * * * *

[FR Doc. 99-23194 Filed 9-3-99; 8:45 am]
BILLING CODE 6560-50-F