[Federal Register Volume 66, Number 90 (Wednesday, May 9, 2001)]
[Notices]
[Pages 23695-23698]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-11521]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-1021; FRL-6780-8]


Notice of Filing Pesticide Petitions 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 pesticide 
petitions proposing the establishment of regulations for residues of 
certain pesticide chemicals in or on various food commodities.

DATES: Comments, identified by docket control number PF-1021, must be 
received on or before June 8, 2001.

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-1021 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: By mail: Treva C. Alston, Registration 
Support Branch, Registration Division (7505C), Office of Pesticide 
Programs, Environmental Protection Agency, 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'' ``Regulation 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-1021. 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-1021 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-1021. 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

[[Page 23696]]

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 pesticide petitions as follows proposing the 
establishment and/or amendment of regulations for residues of certain 
pesticide chemicals in or on various food commodities under section 408 
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. 
EPA has determined that these petitions contain 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: April 26,2001.
James Jones,
Director, Registration Division, Office of Pesticide Programs.

Summaries of Petitions

    Petitioner summaries of the pesticide petitions are printed below 
as required by section 408(d)(3) of the FFDCA. The summaries of the 
petitions were prepared by the petitioner and represent the views of 
the petitioner. EPA is publishing the petition summaries verbatim 
without editing them 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.

Stockhausen, Inc.

PP 1E6281

    EPA has received a pesticide petition (1E6281) from Stockhausen, 
Inc., 2401 Doyle Street, Greensboro, NC 27406 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 to establish an exemption from 
the requirement of a tolerance for 2-propenoic acid, sodium salt, 
polymer with 2-propenamide (acrylamide-sodium acrylate copolymer) when 
used as an inert ingredient as a carrier in pesticide formulations that 
are applied to growing crops or to raw agricultural commodities before 
or after harvest. 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. Toxicological Profile

    Acute toxicity. 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. The Agency believes that polymers meeting the criteria noted 
above will present minimal or no risk. 2-Propenoic acid, sodium salt, 
polymer with 2-propenamide (acrylamide-sodium acrylate copolymer) 
conforms to the definition of polymer given in 40 CFR 723.250(b) and 
meets the following criteria that are used to identify low risk 
polymers.
    1. 2-Propenoic acid, sodium salt, polymer with 2-propenamide 
(acrylamide-sodium acrylate copolymer) is not a cationic polymer, nor 
is it reasonably anticipated to become a cationic polymer in the 
natural aquatic environment.
    2. 2-Propenoic acid, sodium salt, polymer with 2-propenamide 
(acrylamide-sodium acrylate copolymer) contains as an integral part of 
its composition the atomic elements carbon, hydrogen and oxygen.
    3. 2-Propenoic acid, sodium salt, polymer with 2-propenamide 
(acrylamide-sodium acrylate 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)(ii).
    4. 2-Propenoic acid, sodium salt, polymer with 2-
propenamide(acrylamide-sodium acrylate copolymer) is not reasonably 
anticipated to substantially degrade, decompose or depolymerize.
    5. 2-Propenoic acid, sodium salt, polymer with 2-propenamide 
(acrylamide-sodium acrylate 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. 2-Propenoic acid, sodium salt, polymer with 2-propenamide 
(acrylamide-sodium acrylate copolymer) is not a water absorbing polymer 
with a number average molecular weight greater than or equal to 10,0000 
daltons.
    7. 2-Propenoic acid, sodium salt, polymer with 2-propenamide 
(acrylamide-sodium acrylate copolymer) has an average molecular weight 
of 18,000 daltons. 2-Propenoic acid, sodium salt, polymer with 2-
propenamide (acrylamide-sodium acrylate copolymer) meets the 
requirements for molecular weight distribution of oligomer contents of 
less than 5% with molecular weights less than 1,000 and less than 2% 
with molecular weights less than 500.

B. Aggregate Exposure

    Dietary exposure. For the purposes of assessing potential exposure 
under this exemption, it is considered that 2-propenoic acid, sodium 
salt, polymer with 2-propenamide (acrylamide-sodium acrylate copolymer) 
could be present in all raw and processed

[[Page 23697]]

agricultural commodities and drinking water, and that non-occupational 
non-dietary exposure was possible. The number average molecular weight 
of 2-propenoic acid, sodium salt, polymer with 2-propenamide 
(acrylamide-sodium acrylate copolymer) is 18,000 daltons. Generally, a 
polymer of this size would be poorly absorbed through the intact 
gastrointestinal tract or through intact human skin. Since 2-propenoic 
acid, sodium salt, polymer with 2-propenamide (acrylamide-sodium 
acrylate copolymer) conforms to the criteria that identify a low risk 
polymer, there are no concerns for risks associated with any potential 
exposure scenarios that are reasonably foreseeable. Since there is a 
reasonable certainty that no harm will result from aggregate exposure 
to 2-propenoic acid, sodium salt, polymer with 2-propenamide 
(acrylamide-sodium acrylate copolymer), a tolerance is not necessary.

C. Cumulative Effects

    There are no data to support cumulative risk from 2-propenoic acid, 
sodium salt, polymer with 2-propenamide (acrylamide-sodium acrylate 
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 gastrointestinal tract (GI). Chemicals not absorbed through the 
skin or GI tract generally are incapable of eliciting a toxic response. 
Therefore, there is no reasonable expectation of risk due to cumulative 
exposure.

D. Safety Determination

    1. U.S. population. 2-Propenoic acid, sodium salt, polymer with 2-
propenamide (acrylamide-sodium acrylate 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 could be 
additional risk.
    2. Infants and children. 2-Propenoic acid, sodium salt, polymer 
with 2-propenamide (acrylamide-sodium acrylate 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.

E. International Tolerances

    There are no CODEX Maximum Residue Limits established for 2-
propenoic acid, sodium salt, polymer with 2-propenamide (acrylamide-
sodium acrylate copolymer) in/on any crop commodities at this time.

PP 1E6282

    EPA has received a pesticide petition (1E6282) from Stockhausen, 
Inc., 2401 Doyle Street, Greensboro, NC 27406 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 
2-propenoic acid, polymer with 2-propenamide, sodium salt (acrylamide-
sodium acrylate copolymer) when used as an inert ingredient as a 
carrier in pesticide formulations that are applied to growing crops or 
to raw agricultural commodities before or after harvest 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. Toxicological Profile

    Acute toxicity. 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. The Agency believes that polymers meeting the criteria noted 
above will present minimal or no risk. 2-Propenoic acid, polymer with 
2-propenamide, sodium salt (acrylamide-sodium acrylate copolymer) 
conforms to the definition of polymer given in 40 CFR 723.250(b) and 
meets the following criteria that are used to identify low risk 
polymers.
    1. 2-Propenoic acid, polymer with 2-propenamide, sodium salt 
(acrylamide-sodium acrylate copolymer) is not a cationic polymer, nor 
is it reasonably anticipated to become a cationic polymer in the 
natural aquatic environment.
    2. 2-Propenoic acid, polymer with 2-propenamide, sodium salt 
(acrylamide-sodium acrylate copolymer) contains as an integral part of 
its composition the atomic elements carbon, hydrogen and oxygen.
    3. 2-Propenoic acid, polymer with 2-propenamide, sodium salt 
(acrylamide-sodium acrylate 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)(ii).
    4. 2-Propenoic acid, polymer with 2-propenamide, sodium salt 
(acrylamide-sodium acrylate copolymer) is not reasonably anticipated to 
substantially degrade, decompose or depolymerize.
    5. 2-Propenoic acid, polymer with 2-propenamide, sodium salt 
(acrylamide-sodium acrylate 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. 2-Propenoic acid, polymer with 2-propenamide, sodium salt 
(acrylamide- sodium acrylate copolymer) is not a water absorbing 
polymer with a number average molecular weight greater than or equal to 
10,0000 daltons.
    7. 2-Propenoic acid, polymer with 2-propenamide, sodium salt 
(acrylamide-sodium acrylate copolymer) has an average molecular weight 
of 18,000 daltons. 2-Propenoic acid, polymer with 2-propenamide, sodium 
salt (acrylamide-sodium acrylate copolymer) meets the requirements for 
molecular weight distribution of oligomer contents of less than 5% with 
molecular weights less than 1,000 and less than 2% with molecular 
weights less than 500.

B. Aggregate Exposure

    1. Dietary exposure. For the purposes of assessing potential 
exposure under this exemption, it is considered that 2-propenoic acid, 
polymer with 2-propenamide, sodium salt (acrylamide-sodium acrylate 
copolymer) could be present in all raw and processed agricultural 
commodities and drinking water, and that non-occupational non-dietary 
exposure was possible. The number average molecular weight of 2-
propenoic acid, polymer with 2-propenamide, sodium salt (acrylamide-
sodium acrylate copolymer) is 18,000 daltons. Generally, a polymer of 
this size would be poorly absorbed through the intact gastrointestinal 
tract or through intact human skin. Since 2-propenoic acid, polymer 
with 2-propenamide, sodium salt (acrylamide-sodium acrylate copolymer) 
conforms to the criteria that identify a low risk polymer, there are no 
concerns for risks associated with any potential exposure scenarios 
that are reasonably

[[Page 23698]]

foreseeable. Since there is a reasonable certainty that no harm will 
result from aggregate exposure to 2-propenoic acid, polymer with 2-
propenamide, sodium salt (acrylamide-sodium acrylate copolymer), a 
tolerance is not necessary.

C. Cumulative Effects

    There are no data to support cumulative risk from 2-propenoic acid, 
polymer with 2-propenamide, sodium salt (acrylamide-sodium acrylate 
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 gastrointestinal tract (GI). Chemicals not absorbed through the 
skin or GI tract generally are incapable of eliciting a toxic response. 
Therefore, there is no reasonable expectation of risk due to cumulative 
exposure.

D. Safety Determination

    1. U.S. population. 2-Propenoic acid, polymer with 2-propenamide, 
sodium salt (acrylamide-sodium acrylate 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 could be 
additional risk.
    2. Infants and children. 2-Propenoic acid, polymer with 2-
propenamide, sodium salt (acrylamide-sodium acrylate 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.

E. International Tolerances

    There are no CODEX Maximum Residue Limits established for 2-
propenoic acid, polymer with 2-propenamide, sodium salt (acrylamide-
sodium acrylate copolymer) in/on any crop commodities at this time.

[FR Doc. 01-11521 Filed 5-8-01; 8:45 am]
BILLING CODE CODE 6560-50-S