[Federal Register Volume 65, Number 197 (Wednesday, October 11, 2000)]
[Notices]
[Pages 60432-60435]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-25751]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-979; FRL-6749-6]


Notice of Filing a Pesticide Petition to Establish a Tolerance 
for a Certain Pesticide Chemical in or on Food

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Notice.

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SUMMARY:  This notice announces the initial filing of a pesticide 
petition proposing the establishment of regulations for residues of a 
certain pesticide chemical in or on various food commodities.

DATES:  Comments, identified by docket control number PF-979, must be 
received on or before November 13, 2000.

ADDRESSES:  Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit I.C. of the SUPPLEMENTARY INFORMATION. To ensure 
proper receipt by EPA, it is imperative that you identify docket 
control number PF-979 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT:  By mail: Kathryn Boyle, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (703) 305-6304; 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/.
    2. In person. The Agency has established an official record for 
this action under docket control number PF-979. The official record 
consists of the documents specifically referenced in this action, any 
public comments received during an applicable comment period, 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

[[Page 60433]]

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 Highway, 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.

C. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or 
electronically. To ensure proper receipt by EPA, it is imperative that 
you identify docket control number PF-979 in the subject line on the 
first page of your response.
    1. By mail. Submit your comments to: Public Information and Records 
Integrity Branch (PIRIB), Information Resources and Services Division 
(7502C), Office of Pesticide Programs (OPP), Environmental Protection 
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    2. In person or by courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Information Resources 
and Services Division (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 
Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
PIRIB telephone number is (703) 305-5805.
    3. Electronically. You may submit your comments electronically by 
e-mail to: [email protected], or you can submit a computer disk as 
described above. Do not submit any information electronically that you 
consider to be CBI. Avoid the use of special characters and any form of 
encryption. Electronic submissions will be accepted in Wordperfect 6.1/
8.0 or ASCII file format. All comments in electronic form must be 
identified by docket control number PF-979. Electronic comments may 
also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI That I Want to Submit to the Agency?

    Do not submit any information electronically that you consider to 
be CBI. You may claim information that you submit to EPA in response to 
this document as CBI 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. In addition to one complete 
version of the comment that includes any information claimed as CBI, a 
copy of the comment that does not contain the information claimed as 
CBI must be submitted for inclusion in the public version of the 
official record. Information not marked confidential will be included 
in the public version of the official record without prior notice. If 
you have any questions about CBI or the procedures for claiming CBI, 
please consult the person identified under FOR FURTHER INFORMATION 
CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your 
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used 
that support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Make sure to submit your comments by the deadline in this 
notice.
    7. To ensure proper receipt by EPA, be sure to identify the docket 
control number assigned to this action in the subject line on the first 
page of your response. You may also provide the name, date, and Federal 
Register citation.

II. What Action is the Agency Taking?

    EPA has received a pesticide petition as follows proposing the 
establishment and/or amendment of regulations for residues of a certain 
pesticide chemical in or on various food commodities under section 408 
of the Federal Food, Drug, and Comestic Act (FFDCA), 21 U.S.C. 346a. 
EPA has determined that this petition contains data or information 
regarding the elements set forth in section 408(d)(2); however, EPA has 
not fully evaluated the sufficiency of the submitted data at this time 
or whether the data support granting of the petition. Additional data 
may be needed before EPA rules on the petition.

List of Subjects

    Environmental protection, Agricultural commodities, Feed additives, 
Food additives, Pesticides and pests, Reporting and recordkeeping 
requirements.


    Dated: September 29, 2000.

James Jones,

Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

    The petitioner summary of the pesticide petition is printed below 
as required by section 408(d)(3) of the FFDCA. The summary of the 
petition was prepared by the petitioner and represents the view of the 
petitioner. EPA is publishing the petition summary verbatim without 
editing it in any way. The petition summary announces the availability 
of a description of the analytical methods available to EPA for the 
detection and measurement of the pesticide chemical residues or an 
explanation of why no such method is needed.

Avecia Biocides

PP 0F6172

    EPA has received a pesticide petition (PP 0F6172) from Avecia 
Biocides, 1405 Foulk Road P.O. Box 15457 Wilmington, DE 19859 
proposing, pursuant to section 408(d) of the FFDCA, 21 U.S.C. 346a(d), 
to amend 40 CFR part 180 to establish an exemption from the requirement 
of a tolerance for 1,2 benzisothiazoline-3-one (BIT) when used as a 
preservative/stabilizer in pesticide formulations applied to animals. 
EPA has determined that the petition contains data or information 
regarding the elements set forth in section 408(d)(2) of the FFDCA; 
however, EPA has not fully evaluated the sufficiency of the submitted 
data at this time or whether the data support granting of the petition. 
Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

    1. Analytical method. Because Avecia Biocides is petitioning for an 
exemption from the requirement of a tolerance, an enforcement 
analytical method for BIT is not needed.
    2. Magnitude of residues. Based on the proposed amount of BIT to be 
used in the final products (0.1% or less of the total formulation) and 
the recommended frequency and rates of application to the animals, the 
residues in treated animals are expected to be essentially undetectable 
and not toxicologically significant.

B. Toxicological Profile

    1. Acute toxicity. The acute oral toxicity of technical BIT is 
relatively low by oral and dermal exposure. The

[[Page 60434]]

acute oral median lethal dose (MLD) of the technical is 700-800 
milligrams/kilograms (mg/kg) (toxicity category III) in rats and the 
acute dermal LD50 in rats is >2,000 mg/kg (toxicity category 
III). Technical BIT is slightly irritating to rabbit skin following a 
single 4 hour exposure and an abbreviated rabbit eye irritation study 
showed technical BIT to be a severe eye irritant. In skin sensitization 
studies using guinea pigs, technical BIT was shown to be a moderate 
skin sensitizer under the conditions of the test.
    2. Genotoxicty. Generally, BIT is non-mutagenic in the Ames test 
with and without metabolic activation. In cases where the Ames test has 
produced positive responses the responses are either not reproducible 
or lack a dose response effect. In a L5178Y mouse lymphoma cell test, 
BIT produced a negative response both in the presence and absence of S9 
activation, indicating it is non-mutagenic in mammalian cells. Negative 
responses were also seen in vitro in a DNA repair assay. In an in vivo 
mouse bone marrow micronucleus assay, BIT produced a negative response, 
indicating that it was not cytotoxic to bone marrow cells. BIT did not 
induce unscheduled DNA synthesis in rat hepatocytes. The conclusion 
from the results of these various assays is that BIT presents no 
significant genotoxic hazard, either in vitro or in vivo.
    3. Reproductive and developmental toxicity. In a rat teratology 
study, doses up to 100 mg/kg/day of the technical BIT administered from 
days 7-16 of gestation did not cause any teratogenic effects. The 
highest dose level was maternally toxic and was marginally toxic to the 
fetuses. The no observed adverse effect level (NOAEL) for fetal 
toxicity was 40 mg/kg/day and 10 mg/kg/day for maternal toxicity.
    4. Subchronic toxicity. NOAELs for BIT have been determined in 2 
subchronic studies. In a 90 day feeding study conducted with rats in 
which the animals received 0, 200, 900, or 4,000 ppm of BIT technical 
paste in the diet, the only toxic effects observed occurred in the high 
dose animals and consisted of decreased body weights (bwts) (both 
sexes) and reduced food consumption (females). Hyperplasia of the fore 
stomach observed histopathologically in high dose animals was 
considered to be due to irritation by the test material. The 
toxicological NOAEL was 900 parts per million (ppm) (about 74 mg/kg/
day).
    In another subchronic study, male and female beagle dogs (4 animals 
sex/dose) were dosed orally for 90 days with 0, 5, 20, or 50 mg/kg/day 
of the BIT technical paste in corn oil. No toxicologically significant 
effects were seen in any dose group, resulting in a toxicological NOAEL 
of 50 mg/kg/day. The absolute NOAEL in the study was 5 mg/kg/day.
    5. Chronic toxicity. Although no chronic studies have been 
conducted on BIT, the proposed use of BIT as an inert ingredient 
(preservative/stabilizer) in pesticide products applied to animals is 
not expected to create or result in chronic exposure to humans. The 
combined results from various mutagenicity studies indicate that BIT is 
not genotoxic. The effects noted in the subchronic studies in both rats 
and dogs did not indicate concern for potential chronic toxicity. Since 
BIT is not structurally similar to a known carcinogen, all current 
available evidence indicates that BIT would not be carcinogenic.
    6. Animal metabolism. Rats administered radiolabelled BIT by gavage 
showed that most (86%) of the radioactivity was excreted within 24 
hours. A total of 96% (91% in urine, 5% in feces) was excreted in 5 
days. Analysis of abdominal fat after repeated dosing with BIT showed 
no accumulation of BIT or any of its metabolites. In another study 
comparing the metabolism of BIT in the rat and dog, the routes of 
metabolism in the 2 species were shown to be essentially similar. 
Breakdown of BIT by both species was rapid and was carried essentially 
to completion since no unchanged BIT was found in either rat or dog 
urine.
    7. Metabolite toxicology. Metabolism studies in both the rat and 
dog showed that BIT was rapidly and completely metabolized by both 
species. The metabolites identified included o-
(methylsulphinly)benzamide, and o-(methylsulphonyl)benzamide. The 
studies showed there were no significant accumulation of BIT or its 
metabolites in either species. There are, therefore, no significant 
concerns regarding the toxicity of BIT or its metabolites.
    8. Endocrine disruption. BIT does not appear to disrupt (block, 
enhance, or mimic) normal endocrine function. BIT is not structurally 
similar to natural hormones, especially estrogens, androgens, and 
thyroid hormones.

C. Aggregate Exposure

    1. Dietary exposure--i. Food. Based on the toxicity data, an 
aggregate risk or likelihood of the occurrence of an adverse health 
effect resulting from all routes of exposure to BIT is not expected. 
There are not acute toxicological concerns associated with the proposed 
use of BIT as an inert ingredient in animal pesticide products. An 
acute dietary risk assessment, therefore, is not required.
    Chronic exposure to BIT through food is essentially insignificant. 
This is illustrated by using cattle as an example because proposed dose 
rates as well as frequency of dosing will be higher in this species 
that other potential food source animals such as sheep or swine. The 
absolute maximum accumulated dose of BIT which could be received by an 
animal based on the highest number of applications permitted at the 
highest dose rates would not exceed 280 mg of BIT per year, based on a 
maximum of 20 applications per animal per year. This is assuming 100% 
of each dose of the pesticide is absorbed through the skin whether it 
is applied as a pour-on or a spray. For a 500 kg cow this amounts to 
0.56 mg/kg BIT per year. Metabolism studies show that 96% of BIT is 
excreted within 5 days. If it were assumed that the remaining 4% of BIT 
is not excreted and accumulates in the animal, this would leave 0.022 
mg/kg BIT per animal. Assuming a maximum dietary intake of 16 ounces of 
beef per day, an average 70 kg adult would ingest 0.01 mg of BIT, which 
is 0.0001 mg/kg per day. A 28 kg child consuming an average of 4 ounces 
of beef per day would ingest 0.002 mg of BIT per day, which is 0.00007 
mg/kg/day. These calculations indicate that levels of BIT in the diet 
resulting from its proposed use in animal pesticide products are 
essentially insignificant in both adults and children, even when highly 
exaggerated levels of product absorption and food consumption are used 
in the calculations. It is assumed that infants will not be consuming 
any beef. Potential exposure to BIT through milk consumption, even to 
children during the years of highest consumption of cows' milk, is 
considered to be negligible.
    ii. Drinking water. Contamination of drinking water would not be 
expected to occur under the proposed use conditions of BIT as an inert 
preservative/stabilizer in very low concentrations in pesticide 
products intended for topical applications only. The end use product 
would be applied principally to cattle and other domestic animals as 
either a direct pour-on application or as a spray. Neither method of 
application is expected to contaminate water supplies intended for 
human consumption.
    2. Non-dietary exposure. The proposed use of BIT as a preservative/
stabilizer in end-use animal pesticide formulations is not expected to 
result in any significant non-dietary exposure due to the low 
concentration of BIT employed in the formulation and the

[[Page 60435]]

extremely low probability of significant contact by the general public 
following animal treatment.

D. Cumulative Effects

    The cumulative exposure assessment provides an estimate of the 
extent to which a defined population is exposed to two or more 
chemicals that share a common mechanism of toxicity by all relevant 
routes and from all relevant sources. Essentially all exposure from 
this proposed use of BIT will occur via the diet in the form of meat 
consumed from animals treated topically with products intended to 
control external parasites. As discussed above, the levels consumed 
should not exceed 0.0001 mg/kg/day for adults and 0.00007 mg/kg/day for 
children. No additional exposure of the general public is expected from 
either drinking water or non-dietary sources. Even using extremely 
conservative assumptions, the calculated exposure levels are so low as 
to be insignificant. The risk of cumulative effects and/or toxicity 
from BIT is negligible.

E. Safety Determination

    1. U.S. population. No adverse effects of any kind would be 
expected from the extremely low dietary levels of BIT that may result 
from the proposed use of BIT in animal pesticide formulations.
    2. Infants and children. Nothing in the available literature would 
suggest that infants and children are more sensitive to the effects of 
BIT than adults. Since the calculated dietary exposure of children to 
BIT is even less than adults, this proposed use of BIT should not pose 
a risk to this population subgroup. Exposure of infants to BIT 
resulting from its proposed use is expected to be negligible based on 
the fact that beef is not a normal dietary component for this 
population. In summary the proposed use of BIT as an inert ingredient 
in certain animal pesticides formulations will not put infants and 
children at risk.

F. International Tolerances

    No Codex maximum residue levels have been established for BIT.
[FR Doc. 00-25751 Filed 10-10-00; 8:45 am]
BILLING CODE 6560-50-S