[Federal Register Volume 63, Number 97 (Wednesday, May 20, 1998)]
[Notices]
[Pages 27727-27730]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-13446]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-804; FRL-5788-8]


Westvaco Corporation; Pesticide Tolerance Petition Filing

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 the docket control number PF-804, must 
be received on or before June 19, 1998.
ADDRESSES: By mail submit written comments to: Information and Records 
Integrity Branch, Public Information and Services Divison (7502C), 
Office of Pesticides Programs, Environmental Protection Agency, 401 M 
St., SW., Washington, DC 20460. In person bring comments to: Rm. 119, 
CM #2, 1921 Jefferson Davis Highway, Arlington, VA.
    Comments and data may also be submitted electronically by following 
the instructions under ``SUPPLEMENTARY INFORMATION.'' No confidential 
business information should be submitted through e-mail.
    Information submitted as a comment concerning this document may be 
claimed confidential by marking any part or all of that information as 
``Confidential Business Information'' (CBI). CBI should not be 
submitted through e-mail. Information marked as CBI will not be 
disclosed except in accordance with procedures set forth in 40 CFR part 
2. A copy of the comment 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. All written 
comments will be available for public inspection in Rm. 119 at the 
address given above, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: Bipin C. Gandhi, Registration Support 
Branch, Registration Division (7505W), Office of Pesticide Programs, 
Environmental Protection Agency, 401 M St., SW, Washington, DC 20460. 
Office location, telephone number, and e-mail address: Rm. 4-W53, 
Crystal Station 1, 2800 Jefferson Davis Highway, Arlington, VA 
22202, (703) 308-8380; e-mail: [email protected].
SUPPLEMENTARY INFORMATION: 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.
    The official record for this notice of filing, as well as the 
public version, has been established for this notice of filing under 
docket control number [PF-804] (including comments and data submitted 
electronically as described below). A public version of this record, 
including printed, paper versions of electronic comments, which does 
not include any information claimed as CBI, is available for inspection 
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The official record is located at the address in 
``ADDRESSES'' at the beginning of this document.
    Electronic comments can be sent directly to EPA at:
    [email protected]


    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption. Comment and data 
will

[[Page 27728]]

also be accepted on disks in Wordperfect 5.1/6.1 file format or ASCII 
file format. All comments and data in electronic form must be 
identified by the docket control number (PF-804) and appropriate 
petition number. Electronic comments on this notice may be filed online 
at many Federal Depository Libraries.

List of Subjects

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

    Dated: May 4, 1998.

Peter Caulkins,

Acting 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 petitioners and represent the views of 
the petitioners. 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.

1. Westvaco Corporation

PP 6E4749

    EPA has received a pesticide petition (PP 6E4749) from Westvaco 
Corporation, Chemical Division, 3950 Faber Place Drive, North 
Charleston, SC 29405, proposing pursuant to section 408(d) of the 
Federal Food, Drug and Cosmetic Act, 21 U.S.C. 346a(d), to amend 40 CFR 
part 180 to establish an exemption from the requirement of a tolerance 
for residues of acrylic acid, styrene, alpha-methyl styrene copolymer 
ammonium salt (CAS Reg. No. 89678-90-0) when used as an inert 
ingredient (encapsulating agent, dispensers, resins, fibers and beads) 
in pesticide formulations applied to growing crops or raw agricultural 
commodities after harvest, under 40 CFR 180.1001(c) and applied to 
animals under 40 CFR 180.1001(e). 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. Toxicity Data

    As part of the EPA policy statement on inert ingredients published 
in the Federal Register of April 22, 1987 (52 FR 13305) (FRL-3190-1), 
the Agency set forth a list of studies which would generally be used to 
evaluate the risks posed by the presence of an inert ingredient in a 
pesticide formulation. However, where it can be determined without the 
data that the inert ingredient will present minimal or no risk, the 
Agency generally does not require some or all of the listed studies to 
rule on the proposed tolerance or exemption from the requirement of a 
tolerance for an inert ingredient. Westvaco believes that the data and 
information described below is adequate to ascertain the toxicology and 
characterize the risk associated with the use of acrylic acid, styrene, 
alpha-methyl styrene copolymer ammonium salt (CAS Reg. No. 89678-90-0) 
as an inert ingredient in pesticide formulations applied to growing 
crops and raw agricultural commodities after harvest.
    In the case of certain chemical substances that are defined as 
``polymers'' the EPA has established a set of criteria which identify 
categories of polymers that present low risk. These criteria (described 
in 40 CFR 723.250) identify polymers that are relatively unreactive and 
stable 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 EPA believes that 
polymers meeting the criteria noted below will present minimal or no 
risk.
    Acrylic acid, styrene, alpha-methyl styrene copolymer ammonium salt 
(CAS Reg. No. 89678-90-0) 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. Acrylic acid, styrene, alpha-methyl styrene copolymer ammonium 
salt is not a cationic polymer, nor is it reasonably anticipated to 
become a cationic polymer in a natural aquatic environment.
    2. Acrylic acid, styrene, alpha-methyl styrene copolymer ammonium 
salt contains as an integral part of its composition the atomic 
elements carbon and hydrogen.
    3. Acrylic acid, styrene, alpha-methyl styrene copolymer ammonium 
salt does not contain as an integral part of its composition, except as 
impurities, any elements other than those listed in 40 CFR 
723.250(d)(2)(ii).
    4. Acrylic acid, styrene, alpha-methyl styrene ammonium salt 
copolymer is not designed, nor is it reasonably anticipated to 
substantially degrade, decompose, or depolymerize.
    5. Acrylic acid, styrene, alpha-methyl styrene copolymer ammonium 
salt is not manufactured or imported from monomers and/or other 
reactants that are not already included on the Toxic Substance Control 
Act (TSCA) Chemical Substance Inventory or manufactured under an 
applicable TSCA section 5 exemption.
    6. Acrylic acid, styrene, alpha-methyl styrene copolymer ammonium 
salt is not a water absorbing polymer.
    7. Acrylic acid, styrene, alpha-methyl styrene copolymer ammonium 
salt does not contain any group as reactive functional groups.
    8. The minimum number-average molecular weight of the acrylic acid, 
styrene, alpha-methyl styrene copolymer is listed as 1,200 daltons. 
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 
gastrointestinal (GI) tract. Chemicals not absorbed through the skin or 
GI tract generally are incapable of eliciting a toxic response.
    9. The Acrylic acid, styrene, alpha-methyl styrene copolymer has a 
number-average molecular weight of 1,200 and contains less than 10% 
oligomeric material below molecular weight 500 and less than 25% 
oligomeric material below 1,000 molecular weight.
    In addition, acrylic acid, styrene, alpha-methyl styrene copolymer 
is approved by the Food and Drug Administration (FDA) under 21 CFR for 
contact with food as a component in adhesives (21 CFR 175.105), 
coatings (21 CFR 175.300), and paper and paperboard (21 CFR 176.170). 
The ammonium hydroxide utilized to form the ammonium salt is listed in 
21 CFR 184.1139 under the section, ``Direct food substances affirmed as 
generally recognized as safe''.

B. Aggregate Exposure

    Acrylic acid, styrene, alpha-methyl styrene copolymer ammonium salt 
formulations have been in commerce since the mid 1960's. The copolymer 
is ubiquitous in our every day environment and as it is commonly used 
in flexographic printing inks and coatings, such as on newspapers,

[[Page 27729]]

corrugated boxes (e.g. pizza boxes) and disposable drinking cups.
    Although exposure to acrylic acid, styrene, alpha-methyl styrene 
copolymer ammonium salt may occur through dietary (e.g., food wrapping 
containing copolymer) and non-occupational (e.g., printed articles) 
sources, the chemical characteristics of acrylic acid, styrene, alpha-
methyl styrenecopolymer ammonium salt lead to the conclusion that there 
is a reasonable certainty of no harm from aggregate exposure to the 
polymer. Given the existing widespread and historic use of acrylic 
acid, styrene, alpha-methyl styrene copolymer ammonium salt, any 
additional exposure resulting from the approval of the copolymer as an 
inert ingredient in pesticide formulations for use on growing crops or 
to raw agricultural commodities after harvest is not warranted.

C. Cumulative Effects

    At this time there is no information to indicate that any toxic 
effects produced by acrylic acid, styrene, alpha-methyl styrene 
copolymer ammonium salt would be cumulative with those of any other 
chemical. Given the compound's categorization as a ``low risk polymer'' 
(40 CFR 723.250) and its proposed use as an inert ingredient in 
pesticide formulations, there is no reasonable expectation of increased 
risk due to cumulative exposure.

D. International Tolerances

    Westvaco is petitioning that acrylic acid, styrene, alpha-methyl 
styrene copolymer ammonium salt be exempt from the requirement of a 
tolerance based upon its status as a low risk polymer as per 40 CFR 
723.250. Therefore, analytical method to determine residues of acrylic 
acid, styrene, alpha-methyl styrene copolymer in raw agricultural 
commodities treated with pesticide formulations containing acrylic 
acid, styrene, alpha-methyl styrene copolymer have not been proposed.

2. Westvaco Corporation

PP 6E4750

    EPA has received a pesticide petition (PP 6E4750) from Westvaco 
Corporation, Chemical Division, 3950 Faber Place Drive, North 
Charleston, SC 29405, proposing pursuant to section 408(d) of the 
Federal Food, Drug and Cosmetic Act, 21 U.S.C. 346a(d), to amend 40 CFR 
part 180 to establish an exemption from the requirement of a tolerance 
for residues of styrene, 2-ethylhexyl acrylate, butyl acrylate 
copolymer (CAS Reg. No. 30795-23-4) when used as an inert ingredient 
(encapsulating agent, dispensers, resins, fibers and beads) in 
pesticide formulations applied to growing crops or raw agricultural 
commodities after harvest, under 40 CFR 180.1001(c) and applied to 
animals under 40 CFR 180.1001(e). 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. Toxicity Data

    As part of the EPA policy statement on inert ingredients published 
in the Federal Register of April 22, 1987 (52 FR 13305) (FRL-3190-1), 
the Agency set forth a list of studies which would generally be used to 
evaluate the risks posed by the presence of an inert ingredient in a 
pesticide formulation. However, where it can be determined without the 
data that the inert ingredient will present minimal or no risk, the 
Agency generally does not require some or all of the listed studies to 
rule on the proposed tolerance or exemption from the requirement of a 
tolerance for an inert ingredient. Westvaco believes that the data and 
information described below is adequate to ascertain the toxicology and 
characterize the risk associated with the use of styrene, 2-ethylhexyl 
acrylate, butyl acrylate copolymer (CAS Reg. No. 30795-23-4) as an 
inert ingredient in pesticide formulations applied to growing crops and 
raw agricultural commodities after harvest.
    In the case of certain chemical substances that are defined as 
``polymers'', the EPA has established a set of criteria which identify 
categories of polymers that present low risk. These criteria (described 
in 40 CFR 723.250) identify polymers that are relatively unreactive and 
stable 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 EPA believes that 
polymers meeting the criteria noted below will present minimal or no 
risk.
    Styrene, 2-ethylhexyl acrylate, butyl acrylate copolymer (CAS Reg. 
No. 30795-23-4) 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. Styrene, 2-ethylhexyl acrylate, butyl acrylate copolymer is not 
a cationic polymer, nor is it reasonably anticipated to become a 
cationic polymer in a natural aquatic environment.
    2. Styrene, 2-ethylhexyl acrylate, butyl acrylate copolymer 
contains as an integral part of its composition the atomic elements 
carbon, chlorine, and hydrogen.
    3. Styrene, 2-ethylhexyl acrylate, butyl acrylate copolymer does 
not contain as an integral part of its composition, except as 
impurities, any elements other than those listed in 40 CFR 723.250 
(d)(2)(ii).
    4. Styrene, 2-ethylhexyl acrylate, butyl acrylate copolymer is not 
designed, nor is it reasonably anticipated to substantially degrade, 
decompose, or depolymerize.
    5. Styrene, 2-ethylhexyl acrylate, butyl acrylate copolymer is not 
manufactured or imported from monomers and/or other reactants that are 
not already included on the Toxic Substance Control Act (TSCA) Chemical 
Substance Inventory or manufactured under an applicable TSCA section 5 
exemption.
    6. Styrene, 2-ethylhexyl acrylate, butyl acrylate copolymer is not 
a water absorbing polymer.
    7. Styrene, 2-ethylhexyl acrylate, butyl acrylate copolymer does 
not contain any group as reactive functional groups.
    8. The minimum number-average molecular weight of styrene, 2-
ethylhexyl acrylate, butyl acrylate copolymer is listed as 4,228 
daltons. 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 gastrointestinal (GI) tract. Chemicals not absorbed through the 
skin or GI tract generally are incapable of eliciting a toxic response.
    9. Styrene, 2-ethylhexyl acrylate, butyl acrylate copolymer has a 
number-average molecular weight of 4,228 and contains less than 10% 
oligomeric material below molecular weight 500 and less than 25% 
oligomeric material below 1,000 molecular weight.

B. Aggregate Exposure

    Styrene, 2-ethylhexyl acrylate, butyl acrylate copolymer 
formulations have been in commerce since the mid 1960's. The copolymer 
is ubiquitous in our every day environment and as it is commonly used 
in flexographic printing inks and coatings such as on

[[Page 27730]]

newspapers, corrugated boxes (e.g. pizza boxes) and disposable drinking 
cups.
    Although exposure to styrene, 2-ethylhexyl acrylate, butyl acrylate 
copolymer may occur through dietary (e.g., food wrapping containing 
copolymer) and non-occupational (e.g., printed articles) sources, the 
chemical characteristics of styrene, 2-ethylhexyl acrylate, butyl 
acrylate copolymer lead to the conclusion that there is a reasonable 
certainty of no harm from aggregate exposure to the polymer. Given the 
existing widespread and historic use of styrene, 2-ethylhexyl acrylate, 
butyl acrylate copolymer, any additional exposure resulting from the 
approval of the copolymer as an inert ingredient in pesticide 
formulations for use on growing crops or to raw agricultural 
commodities after harvest is not warranted.
    In addition, styrene, 2-ethylhexyl acrylate, butyl acrylate 
copolymer is approved by the Food and Drug Administration (FDA) under 
21 CFR for contact with food as a component in adhesives (21 CFR 
175.105), coatings (21 CFR 175.300), and paper and paperboard (21 CFR 
176.170).

C. Cumulative Effects

    At this time there is no information to indicate that any toxic 
effects produced by styrene, 2-ethylhexyl acrylate, butyl acrylate 
copolymer would be cumulative with those of any other chemical. Given 
the compound's categorization as a ``low risk polymer'' (40 CFR 
723.250) and its proposed use as an inert ingredient in pesticide 
formulations, there is no reasonable expectation of increased risk due 
to cumulative exposure.

D. International Tolerances

    Westvaco is petitioning that styrene, 2-ethylhexyl acrylate, butyl 
acrylate copolymer be exempt from the requirement of a tolerance based 
upon its status as a low risk polymer as per 40 CFR 723.250. Therefore, 
analytical methods to determine residues of styrene, 2-ethylhexyl 
acrylate, butyl acrylate copolymer in raw agricultural commodities 
treated with pesticide formulations containing styrene, 2-ethylhexyl 
acrylate, butyl acrylate copolymer have not been proposed.
[FR Doc. 98-13446 Filed 5-19-98; 8:45 am]
BILLING CODE 6560-50-F