[Federal Register Volume 65, Number 52 (Thursday, March 16, 2000)]
[Notices]
[Pages 14278-14280]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-6567]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-922; FRL-6494-9]


Notice of Filing a Pesticide Petition To Establish a Tolerance 
for Certain Pesticide Chemicals 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-922, must be 
received on or before April 17, 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-922 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT:  By mail: Treva Alston, Minor Use, 
Inerts, and Emergency Response Branch, Registration Division (7505C), 
Office of Pesticide Programs, Environmental Protection Agency, Ariel 
Rios Bldg., 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (703) 308-8373; 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'' 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-922. 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 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-922 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, Ariel Rios Bldg., 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-922. Electronic comments may 
also be filed online at many Federal Depository Libraries.

[[Page 14279]]

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 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 supports 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: March 8, 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.

Rohm and Haas Company

8E4957

    EPA has received a pesticide petition (8E4957) from Rohm and Haas 
Company, 100 Independence Mall West, Philadelphia, PA 19106-2399 
proposing, pursuant to section 408(d) of the Federal Food, Drug, and 
Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 
180.1001(c) and (e) to establish an exemption from the requirement of a 
tolerance for butyl acrylate/vinyl acetate/acrylic acid copolymer when 
used in accordance with good agricultural practices as an inert 
ingredient in pesticide formulations applied to growing crops in or on 
the raw agricultural commodity (RAC) after harvest or 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 supports granting of the petition. Additional 
data may be needed before EPA rules on the petition.

A. Residue Chemistry

    Analytical method. Rohm and Haas is petitioning that butyl 
acrylate/vinyl acetate/acrylic acid copolymer be exempt from the 
requirement of a tolerance based upon the low risk polymer as per 40 
CFR 723.250. Therefore, an analytical method to determine residues of 
butyl acrylate/vinyl acetate/acrylic acid copolymer in RACs has not 
been proposed.

B. Toxicological Profile

    Acute toxicity. In the case of certain chemical substances that are 
defined as ``polymers,'' the Agency has established a set of criteria 
which identifies categories of polymers that present low risk. These 
criteria (described in 40 CFR 723.250) identify polymers that are 
relatively unreactive and stable compounds compared to other chemical 
substances as well as polymers that typically are not readily absorbed. 
These properties generally limit a polymer's ability to cause adverse 
effects. In addition, these criteria exclude polymers about which 
little is known. The Agency believes that polymers meeting the criteria 
noted above will present minimal or no risk. Butyl acrylate/vinyl 
acetate/acrylic acid copolymer conforms to the definition of a polymer 
given in 40 CFR 723.250(b) and meets the following criteria that are 
used to identify low risk polymers.
    1. Butyl acrylate/vinyl acetate/acrylic acid copolymer is not a 
cationic polymer, nor is it capable of becoming a cationic polymer in 
the natural aquatic environment.
    2. Butyl acrylate/vinyl acetate/acrylic acid copolymer contains as 
an integral part of its composition the atomic elements carbon, 
hydrogen, oxygen and less than 0.10% sulfur.
    3. Butyl acrylate/vinyl acetate/acrylic acid copolymer does not 
contain as an integral part of its composition, except as impurities, 
any element other than those listed in 40 CFR 723.250 (d)(2)(iii).
    4. Butyl acrylate/vinyl acetate/acrylic acid copolymer is not 
designed, nor is it reasonably anticipated to substantially degrade, 
decompose or depolymerize.
    5. Butyl acrylate/vinyl acetate/acrylic acid copolymer is not 
manufactured or imported from monomers and/or other reactants that are 
not already included on the TSCA Chemical Substance Inventory or 
manufactured under an applicable TSCA section 5 exemption.
    6. Butyl acrylate/vinyl acetate/acrylic acid copolymer is not a 
water absorbing polymer with a number average molecular weight greater 
than or equal to 10,000 daltons.
    7. The minimum number average molecular weight of butyl acrylate/
vinyl acetate/acrylic acid copolymer is 18,500 daltons. Substances with 
molecular weights greater than 400 generally are not absorbed through 
the intact skin, and substances with molecular weights

[[Page 14280]]

greater than 1,000 generally are not absorbed through the intact 
gastrointestinal (GI) tract. Chemicals not absorbed through the skin or 
GI tract generally are incapable of eliciting a toxic response.
    8. Butyl acrylate/vinyl acetate/acrylic acid copolymer has a 
minimum number average molecular weight of 18,500 and contains less 
than 2% oligomeric material below molecular weight 500 and less than 5% 
oligomeric material below 1,000 molecular weight.
    9. Butyl acrylate/vinyl acetate/acrylic acid copolymer does contain 
aliphatic ester groups as reactive functional groups. However, these 
reactive groups are not intended or reasonably anticipated to undergo 
further reactions under usual environmental conditions.
    10. In addition, butyl acrylate/vinyl acetate/acrylic acid 
copolymer is compliant with the Food and Drug Administration (FDA) 
regulations under 21 CFR for contact with food as a component in 
adhesives (21 CFR 175.105), as a component of paper and paperboard in 
contact with dry foods (21 CFR 176.180) and aqueous and fatty foods (21 
CFR 176.170) with limitations as set forth in 21 CFR 176.170(c).

C. Metabolite Toxicology

    Endocrine disruption. There is no evidence that butyl acrylate/
vinyl acetate/acrylic acid copolymer is an endocrine disrupter, where 
as substances with molecular weights greater than 400 generally are not 
absorbed through the intact skin, and substances with molecular weights 
greater than 1,000 generally are not absorbed through the intact GI 
tract. Chemicals not absorbed through the skin or GI tract generally 
are incapable of eliciting a toxic response.

D. Aggregate Exposure

    1. Dietary exposure. Butyl acrylate/vinyl acetate/acrylic acid 
copolymer is not absorbed through the intact GI tract and is considered 
incapable of eliciting a toxic response.
    Drinking water. Based upon the aqueous insolubility of butyl 
acrylate/vinyl acetate/acrylic acid copolymer, there is no reason to 
expect human exposure to residues in drinking water.
    2. Non-dietary exposure. Butyl acrylate/vinyl acetate/acrylic acid 
copolymer is widely used in multilayer paper packaging production, as a 
component in box and packaging sealant, and to a lesser extent in the 
``casing'' found on books for protection. Although there may be 
exposures to the compound through dietary, non-occupational and most 
likely not through drinking water, the chemical characteristics of this 
compound are such that there is reasonable certainty of no harm from 
aggregate exposure.

E. Cumulative Effects

    There are data to support cumulative risk from butyl acrylate/vinyl 
acetate/acrylic acid copolymer, since polymers with molecular weights 
greater than 400 generally are not absorbed through the intact skin, 
and substances with molecular weights greater than 1,000 generally are 
not absorbed through the intact GI tract. Chemicals not absorbed 
through the skin or GI tract generally are incapable of eliciting a 
toxic response. Therefore, there is no reasonable expectations of 
increased risk due to cumulative exposure.

F. Safety Determination

    1. U.S. population. Butyl acrylate/vinyl acetate/acrylic acid 
copolymer causes no safety concerns because it conforms to the 
definition of a low risk polymer given in 40 CFR 723.250(b) and as such 
is considered incapable of eliciting a toxic response. Also, there are 
no additional pathways of exposure (non-occupational, drinking water, 
etc.) where there would be additional risk.
    2. Infants and children. Butyl acrylate/vinyl acetate/acrylic acid 
copolymer causes no additional concern to infants and children because 
it conforms to the definition of a low risk polymer given in 40 CFR 
723.250(b) and as such is considered incapable of eliciting a toxic 
response. Also there are no additional pathways of exposure (non-
occupational, drinking water, etc.) where infants and children would be 
at additional risk.

G. International Tolerances

    We are not aware of any country requiring a tolerance for butyl 
acrylate/vinyl acetate/acrylic acid copolymer. Nor have there been any 
CODEX Maximum Residue Levels established for any food crops at this 
time.
[FR Doc. 00-6567 Filed 3-15-00; 8:45 am]
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