[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) * * *
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Inert ingredients Limits Uses
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*****
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
*****
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* * * * *
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]
BILLING CODE 6560-50-F
