[Federal Register Volume 65, Number 188 (Wednesday, September 27, 2000)]
[Notices]
[Pages 58078-58080]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-24438]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-972; FRL-6742-4]


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-972, must be 
received on or before October 27, 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-972 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: By mail: Bipin Gandhi, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (703) 308-8380; 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            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-972. 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

[[Page 58079]]

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 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-972 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-972. 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 15, 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 Federal Food Drug and Cosmetic 
Act (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 announce 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.

DuPont Company

PP 6E4785

    EPA has received a pesticide petition (PP 6E4785) from the DuPont 
Company, DuPont Fluoroproducts, Chestnut Run Plaza, P.O. Box 80711, 
Wilmington, DE, 19880-0711 proposing, pursuant to section 408(d) of the 
(FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 by establishing a 
tolerance for residues of dimethylether (CAS Reg. No. 115-10-6) when 
used as an inert ingredient in pesticide formulations applied to 
growing crops or to raw agricultural commodities (RAC) after harvest, 
and including area application in and around commercial and residential 
food handling facilities and establishments by certified applicators 
only. 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

    Analytical method. DME is used as a propellant in pesticide 
formulations and exists as a gas at ambient conditions. Upon release 
from the container, it vaporizes completely with essentially no 
residue; consequently, no analytical method for residue measurement is 
needed.

[[Page 58080]]

B. Toxicological Profile

    Since dimethylether (DME) exists as a gas at room temperature and 
any exposure to humans would occur via inhalation, all toxicity testing 
conducted with DME was done via inhalation or in the vapor phase.
    1. Acute toxicity. An acute inhalation toxicity study was conducted 
in rats. The 4-hr LC50 was determined to be 164,000 parts 
per million (ppm), EPA category IV.
    2. Genotoxicty--i. An in vitro Ames/Salmonella mutagenicity assay 
in five commonly used strains was negative for mutagenic potential.
    ii. An in vitro chromosomal aberration test in cultured human 
lymphocytes was negative for chromosomal aberrations.
    3. Reproductive and developmental toxicity--i. Reproductive organs 
in male and female rats were examined histopathologically following 
inhalation of 0, 2,000, 10,000, or 25,000 ppm DME for 6, 12, 16, and 24 
months. The no observed adverse effect level (NOAEL) in this study was 
25,000 ppm as no compound-related effects on the reproductive organs of 
either male or female rats were observed.
    ii. Developmental toxicity testing was conducted in rats exposed 
via inhalation to DME during days 6-15 of gestation. Fetal body weight 
(bwt) was decreased at the 20,000 and 40,000 ppm levels (of borderline 
statistical significance in the 20,000 ppm group) and there was an 
increased incidence of several skeletal variations (partial rib 
development in the lumbar region and partial or complete doubling of 
one or more vertebral centra). The NOAEL for the conceptus was 1,250 
ppm. In comparison to maternal effect levels, DME was not demonstrated 
to represent a unique hazard to the rat conceptus.
    4. Subchronic toxicity. Male and female Wistar rats were exposed to 
0, 200, 2,000, or 20,000 ppm DME via inhalation for 30 weeks. At the 
20,000 ppm level, male rats showed a significant reduction in liver 
weight accompanied by raised serum glutamic pyruvic transaminase (SGPT) 
levels. In the 20,000 ppm females, there was no significant effect on 
liver weight but SGPT levels were raised. The NOAEL in this study was 
2,000 ppm.
    5. Chronic toxicity. A 2-year DME inhalation study was conducted in 
rats for 6 hours/day, 5 days/week at concentrations of 0, 2,000, 
10,000, or 25,000 ppm. The NOAEL was 2,000 ppm based on an increase in 
bwt and a decrease in survival in male rats exposed to 10,000 or 25,000 
ppm DME vapors and on hemolytic effects noted in male rats exposed to 
25,000 ppm DME vapors for 6 months. No neoplastic lesions were observed 
that could be attributable to DME exposure. DME was not carcinogenic.
    6. Animal metabolism. Dimethylether is a volatile, stable compound. 
While no metabolism studies were identified, the primary route of DME 
elimination from the body is likely to be exhalation of parent 
compound.
    7. Endocrine disruption. No adverse endocrine effects have been 
suggested or reported in any toxicity tests conducted with DME.

C. Aggregate Exposure

    1. Dietary exposure. Dimethylether exists as a vapor at atmospheric 
pressure and ambient temperatures. It is handled and contained in 
aerosol products as a liquefied gas under its own vapor pressure which 
is 63 psig at 70 deg.F. Upon release from container pressure, as when 
product is dispensed, dimethylether vaporizes completely with 
essentially no residue. Dimethylether is intended as an inert 
ingredient and propellant for pesticide formulations applied in food 
handling areas and establishments; these products are not intended for 
direct application to foods. Dietary exposure from use of dimethylether 
in these types of products is believed to be minimal, as discussed in 
food and drinking water below.
    i. Food. Based on its physical properties, when dimethylether is 
used as a propellant in pesticide formulations applied in food handling 
areas and establishments, no residue is expected on or in food. Upon 
dispensing the insect control product, the dimethylether will vaporize 
and dissipate quickly, affording no residue or accumulation.
    ii. Drinking water. Similarly, since dimethylether will vaporize 
completely at ambient conditions, no accumulation is expected in 
drinking water. There would be no liquid dimethylether to migrate to 
groundwater aquifers or surface water bodies that may serve as suitable 
drinking water sources.
    2. Non-dietary exposure. The greatest potential for residential 
exposure to dimethylether would be via inhalation routes. However, even 
when these pesticide products are used in small areas, estimated 
dimethylether levels will be lower and of much shorter duration than 
recognized and accepted levels that are considered safe for chronic 
lifetime exposures. Additionally, tests have shown that such aerosol 
propellants dissipate within minutes of use.

D. Cumulative Effects

    There is no reliable information that would indicate or suggest 
that dimethylether has any toxic effect on mammals that would be 
cumulative with those of any other chemical.

E. Safety Determination

    1. U.S. population. Since potential dietary exposures are expected 
to be minimal, if any, and since potential inhalation exposures are 
estimated much lower than recognized and accepted levels considered 
safe for chronic lifetime exposures, dimethylether is not likely to 
pose any significant risk to the general U.S. population.
    2. Infants and children. To the best of our knowledge, there is no 
information that suggests infants and children are more susceptible to 
exposure to or effects of dimethylether. The lack of significant 
toxicity in reproductive/developmental studies on dimethylether 
suggests that growing organisms are not at increased risks. Since 
potential dietary exposures to infants and children are minimal, if 
any, based on anticipated use, it is unlikely that any significant 
risks exist. Direct exposures to infants and children via inhalation 
are not anticipated for the intended use of dimethylether.

F. International Tolerances

    DuPont is not aware of any tolerances for dimethylether outside the 
United States.
[FR Doc. 00-24438 Filed 9-26-00; 8:45 am]
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