[Federal Register Volume 59, Number 119 (Wednesday, June 22, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-15080]


[[Page Unknown]]

[Federal Register: June 22, 1994]


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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180

[OPP-300348; FRL-4871-3]
RIN 2070-AC18

 

Amended Tolerance Exemptions for Encapsulating Polymers

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: This document proposes that the tolerance exemptions for three 
encapsulating polymers, poly(vinylpyrrolidone-1-eicosene), 
poly(vinylpyrrolidone-1-hexadecene), and vinylpyrrolidone-vinyl acetate 
copolymer be amended to removed language not directly related to the 
inert ingredient exemption and to replace the specific tolerance 
exemption listings in 40 CFR part 180 for these polymers with general 
listings under 40 CFR 180.1001(c). This change was requested by 
International Specialty Products. On its own inititative, the Agency is 
also deleting similar language in the tolerance exemption for cross-
linked polyurea-type encapsulating polymer.

DATES: Written comments, identified by the document control number 
[OPP-300348], must be received on or before July 22, 1994.

ADDRESSES: By mail, submit written comments to: Public Response 
Section, Field Operations Division (7506C), Office of Pesticide 
Programs, Environmental Protection Agency, 401 M St., SW., Washington, 
DC 20460. In person, bring comments to: Rm. 1128, CM #2, 1921 Jefferson 
Davis Hwy., Arlington, VA 22202.
    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). Information so marked 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. 1128 at 
the Virginia address given above, from 8 a.m. to 4 p.m., Monday through 
Friday, excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: By mail: Tina Levine, Registration 
Support Branch, Registration Division (7505C), Environmental Protection 
Agency, 401 M St., SW., Washington, DC 20460. Office location and 
telephone number: 2800 Crystal Drive, North Tower, Arlington, VA 22202, 
(703)-308-8393.

SUPPLEMENTARY INFORMATION: International Specialty Products (ISP), 1361 
Alps Rd., Wayne, NJ 07470, has submitted petitions to amend the 
exemptions from tolerance for poly(vinylpyrrolidone-1-eicosene), 
pesticide petition (PP) 4E4307, poly(vinylpyrrolidone-1-hexadecene), PP 
4E4304, and vinylpyrrolidone-vinyl acetate copolymer, PP 4E4306, to 
remove the specific exemptions in 40 CFR part 180 for these polymeric 
encapsulating agents and list them in 40 CFR 180.1001(c). The changes 
would eliminate the following statement which was included in each 
separate exemption from tolerance: ``Registration of each new pesticide 
formulation incorporating this dispersing agent must be supported by 
residue data for the active ingredient(s).'' The petition notes that it 
is EPA's policy that the data requirements for registration are 
associated with registered pesticide products, not inert ingredients. 
Data may be required on a case-by-case basis for a registered product 
when substantial changes are made in the inert ingredients included in 
the product's formulation, but such data requirements are not triggered 
universally by the addition of a specific inert ingredient to the 
formulation.
    The addition of this language to the tolerance exemption was 
triggered by concern that the nature of the inert encapsulating 
material may affect the residue levels of active ingredients and, 
therefore, the Agency needed a mechanism to ensure that each 
formulation of this type be evaluated for this possibility. However, 
the Agency agrees that including this language in the exemption from 
tolerance expression is an inappropriate way to obtain such assurance. 
In August 1993, the Agency issued to product managers internal guidance 
entitled, ``Data Requirements for Formulations and Translation of 
Residue Data between Formulations.'' The document informed product 
managers that any new food-use pesticide product which is considered a 
microencapsulated or controlled-release formulation should be reviewed 
by residue chemists to determine ``if there has been a change in the 
inert ingredients (especially the encapsulating polymer) that could 
affect residues of the active ingredient.'' This internal guidance 
should address the concerns which led to the inclusion of the 
objectionable language in these tolerance exemptions.
    In addition to the three polymers of these petitions, the Agency 
has noted that there is a specific exemption for cross-linked polyurea-
type encapsulating polymer (40 CFR 180.1039) that contains the same 
language as the three polymers for which petitions were submitted as 
well as additional language on quality control procedures to ensure 
predictable release characteristics and relatively uniform toxicity of 
various production lots. This language also refers to data requirements 
for the encapsulated pesticide product formulation and is not 
appropriate to the tolerance exemption for the inert ingredient. 
Therefore, the Agency has also decided to amend this exemption to 
delete the second sentence of the tolerance exemption.
    Any person who has registered or submitted an application for 
registration of a pesticide under the Federal Insecticide, Fungicide, 
and Rodenticide Act, as amended, which contains any of the ingredients 
listed herein may request within 30 days after publication of this 
document in the Federal Register that this rulemaking proposal be 
referred to an Advisory Committee in accordance with section 408(e) of 
the Federal Food, Drug, and Cosmetic Act.
    Interested persons are invited to submit written comments on the 
proposed regulation. Comments must bear a notation indicating the 
document control number, [OPP-300348]. All written comments filed in 
response to this document will be available for public inspection in 
the Public Response and Program Resources Branch, at the Virginia 
address given above, from 8 a.m. to 4 p.m., Monday through Friday, 
except legal holidays.
    The Office of Management and Budget has exempted this rule from the 
requirements of section 3 of Executive Order 12866.
    Pursuant to the requirements of the Regulatory Flexibility Act 
(Pub. L. 96-354, 94 Stat. 1164, 5 U.S.C. 601-612), the Administrator 
has determined that regulations establishing new tolerances or raising 
tolerance levels or establishing exemptions from tolerance requirements 
do not have a significant economic impact on a substantial number of 
small entities. A certification statement to this effect was published 
in the Federal Register of May 4, 1981 (46 FR 24950).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Food additives, Pesticides and pests, 
Reporting and recordkeeping requirements.

Dated: July 13, 1994.

Stephen L. Johnson,
Acting Director, Registration Divison, Office of Pesticide Programs.

    Therefore, it is proposed that 40 CFR part 180 be amended as 
follows:

PART 180--[AMENDED]-

    1. The authority citation for part 180 continues to read as 
follows:

    Authority: 21 U.S.C. 346a and 371.

    2. Section 180.1001(c) is amended by adding and alphabetically 
inserting the inert ingredients, to read as follows:


Sec. 180.1001   Exemptions from the requirement of a tolerance.

*    *    *    *    *
    (c) *  *  *

------------------------------------------------------------------------
               Inert ingredients                   Limits        Uses   
------------------------------------------------------------------------
                                                                        
                                  *****                                 
Poly(vinylpyrrolidone-1-eicosene) (CAS Reg.                             
 No. 28211-18-9)..............................      Minimum             
                                                    average             
                                                  molecular             
                                                     weight             
                                                      3,000   Dispersing
                                                                   agent
Poly(vinylpyrrolidone-1-hexadecene) (CAS Reg.                           
 No. 63231-81-2)..............................      Minimum             
                                                    average             
                                                  molecular             
                                                     weight             
                                                      4,700   Dispersing
                                                                   agent
                                                                        
                                  *****                                 
Vinylpyrrolidone-vinyl acetate copolymer (CAS                           
 Reg. No. 25086-89-9).........................      Minimum             
                                                    average             
                                                  molecular             
                                                     weight             
                                                      6,700     Emulsion
                                                             stabilizer,
                                                                   film-
                                                                 forming
                                                                   agent
                                                                        
                                  *****                                 
------------------------------------------------------------------------

*    *    *    *    *

    3. Section 180.1039 is revised to read as follows:

Sec. 180.1039   Cross-linked polyurea-type encapsulating polymer; 
exemption from the requirement of a tolerance.

    The cross-linked polyurea-type polymer formed by the reduction of a 
mixture of toluene diisocyanate and polymethylene polyphenylisocyanate 
is exempted from the requirement of a tolerance when used as an inert 
encapsulating material for pesticide formulations applied prior to 
planting. The inert will constitute no more than 10 percent by weight 
of any pesticide formulation.

Sec. 180.1104   [Removed]

    4. Section 180.1104 Poly(vinylpyrrolidone/1-eicosene); exemption 
from the requirement of a tolerance is removed.

Sec. 180.1105   [Removed]

    5. Section 180.1105 Poly(vinylpyrrolidone/1-hexadecene); exemption 
from the requirement of a tolerance is removed.

Sec. 180.1106   [Removed]

    6. Section 180.1106 Vinylpyrrolidone-vinyl acetate copolymer; 
exemption from the requirement of a tolerance is removed.

[FR Doc. 94-15080 Filed 6-21-94; 8:45 am]

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