[Federal Register Volume 61, Number 143 (Wednesday, July 24, 1996)]
[Proposed Rules]
[Pages 38426-38428]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-18391]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 3E4254/P658; FRL-5371-2]
Polybutene; Tolerance Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: This document proposes that an exemption from the requirement
of a tolerance be established for residues of polybutene, when used as
an inert ingredient (sticker and spreading agent) in pesticide
formulations applied to growing crops only. This proposed regulation
was requested by Miller Chemical and Fertilizer Corporation pursuant to
the Federal Food, Drug, and Cosmetic Act (FFDCA). This proposed time-
limited exemption from the requirement of a tolerance will expire 2
years and 9 months after promulgation of the final rule in the Federal
Register.
DATES: Comments, identified by the docket control number [PP 3E4254/
P658], must be received on or before August 23, 1996.
ADDRESSES: By mail, submit written comments to: Public Response and
Program Resources Branch, Field
[[Page 38427]]
Operations Division (7506C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
In person deliver comments to: Rm. 1132, Crystal Mall #2, 1921
Jefferson Davis Highway, Arlington, VA.
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 will be included in the public docket by EPA without prior
notice. The public docket is available for public inspection in Rm.
1132 at the address given above, from 8 a.m. to 4:30 p.m., Monday
through Friday, excluding legal holidays.
Comments and data may also be submitted electronically by sending
electronic mail (e-mail) to: opp-docket@epamail.epa.gov. Electronic
comments must be submitted as an ASCII file avoiding the use of special
characters and any form of encryption. Comments and data will also be
accepted on disks in WordPerfect 5.1 file format or ASCII file format.
All comments and data in electronic form must be identified by the
docket number, [PP 3E4254/P658]. No CBI should be submitted through e-
mail. Electronic comments on this proposed rule may be filed online at
many Federal Depository Libraries. Additional information on electronic
submissions can be found below in this document.
FOR FURTHER INFORMATION CONTACT: By mail: Mary Waller, 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: 2800
Crystal Drive, North Tower, Arlington, VA, (703) 308-8320, e-mail:
waller.mary@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: Miller Chemical and Fertilizer Corporation,
P.O. Box 333, 120 Radio Road, Hanover, PA 17331, has submitted
pesticide petition (PP) 3E4254 to EPA requesting that the
Administrator, pursuant to section 408(e) of the Federal Food, Drug,
and Cosmetic Act, 21 U.S.C. 346a(e), propose to amend 40 CFR
180.1001(d) by establishing an exemption from the requirement of a
tolerance for residues of polybutene, when used as an inert ingredient
(sticker and spreading agent) in pesticide formulations applied to
growing crops only.
Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
The data submitted in the petition and other relevant material have
been evaluated. As part of the EPA policy statement on inert
ingredients published in the Federal Register of April 22, 1987 (52 FR
13305), 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
that 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. The results of the data and
evaluations are described below:
1. Acute toxicity data indicated the following: acute oral toxicity
studies established LD50 values ranging from 5,000 mg/kg to 12,000
mg/kg; an acute dermal toxicity study demonstrated no systemic
toxicity; primary eye irritation studies demonstrated minimal eye
irritation; a primary skin irritation study demonstrated no dermal
irritation; and a dermal sensitization study was negative.
2. A 90-day rat oral toxicity study established the systemic
toxicity no-observed-effect level (NOEL) of > 2,500 mg/kg/day.
3. A gene mutation test in cultured/chinese hamster ovary cell
strain AS52 CHO/XPRT showed no evidence of cytotoxicity or mutagenicity
up to a concentration of 1.0 g/plate.
4. An in vivo mammalian marrow cytogenetic test using mice
indicated no increased incidence of micronucleated polychromatic
erythrocytes.
5. The Structural Activity Team (SAT) of the Office of Pollution
Prevention, and Toxics (OPPT) evaluated this inert ingredient based on
the physico-chemical characteristics submitted by the petitioner and
the validated data. The SAT stated that no absorption was expected
through any exposure route, and the health effects of this inert
ingredient are of low concern. The SAT concluded that exposure to the
inert ingredient was not expected to result in any significant health
effects.
6. An avian acute oral toxicity study established an LD50 >
2,150 mg/kg and an avian subacute dietary toxicity study established an
LC50 > 5,000 ppm.
7. Exposure to aquatic environments is considered unlikely based on
the poor solubility and sticky physical characteristic of the inert
ingredient.
8. The inert ingredient is expected to degrade via photochemical
reactions followed by microbial co-metabolism of the photochemical
products. Leaching is not expected because of the inert ingredient's
relative insolubility in water and tendency to adhere to surfaces as a
film.
The Agency does not expect exposure to polybutene to pose a risk to
the public health based on the toxicological profile which indicates a
lack of mutagenicity, the extremely low acute and subchronic toxicity,
and the SAT evaluation which indicated that no absorption was expected
via any exposure route and therefore, exposure to this inert ingredient
would not result in any significant health effects. The Agency has
concluded that ecological effects are minimal based on the extremely
low avian toxicity, and the unique physico-chemical characteristics
which also attributed to the low environmental concern.
Based upon the above information and review of its use, the Agency
has found that, when used in accordance with good agicultural
practices, this inert ingredient is useful and a tolerance is not
necessary to protect the public health. Therefore, EPA proposes that
the exemption from the requirement of a tolerance be established as set
forth below.
The Agency has decided to add a separate section to part 180
instead of amending Sec. 180.1001(d) as proposed by the petitioner.
This change is being made because this is a time-limited exemption from
the requirement of a tolerance and it would not fit well in the table
format of paragraph (d). In addition, this exemption from the
requirement of a tolerance is being proposed as a time-limited
exemption because the Agency does not have data for two required
studies: A 90-day feeding study in dogs and a developmental toxicity
study in rodents. These studies are being required because they are
part of the base set data
[[Page 38428]]
requirements. The Agency will require that the above studies be
submitted within 2 years of the date of promulgation of the final rule
in the Federal Register. When the Agency receives these studies, it
will reassess this exemption from the requirement of a tolerance.
However, based upon the data considered in support of the petition and
the restriction on exposure offered by a time limitation, the Agency
does not believe that this proposed exemption from the requirement of a
tolerance poses a risk to human health or the environment.
Upon adoption, this exemption from the requirement of a tolerance
will expire 2 years and 9 months after promulgation of the final rule
in the Federal Register. Residues will not be considered actionable if
a pesticide containing this inert ingredient is legally applied during
the term of a conditional registration under the Federal Insecticide,
Fungicide and Rodenticide Act (FIFRA), as amended, and in accordance
with the acceptable labeling under a conditional registration. This
exemption from the requirement of a tolerance will be revoked if any
data indicate such revocation is necessary to protect the public
health.
Any person who has registered or submitted an application for
registration of a pesticide, under the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA) 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 proposal be referred
to an Advisory Committee in accordance with section 408(e) of FFDCA.
Interested persons are invited to submit written comments on the
proposed regulation. Comments must bear a notation indicating the
docket control number, [PP 3E4254/P658]. All written comments filed in
response to this petition will be available in the Public Response and
Program Resources Branch.
A record has been established for this rulemaking under docket
number [PP 3E4254/P658] (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 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The public record is located in Room 1132 of the Public
Response and Program Resources Branch, Field Operations Division
(7506C), Office of Pesticide Programs, Environmental Protection Agency,
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
Electronic comments can be sent directly to EPA at:
opp-docket@epamail.epa.gov
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
The official record for this rulemaking, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer all comments received electronically into printed,
paper form as they are received and will place the paper copies in the
official rulemaking record which will also include all comments
submitted directly in writing. The official rulemaking record is the
paper record maintained at the address in ADDRESSES at the beginning of
this document.
The Office of Management and Budget has exempted this proposed rule
from the requirements of section 3 of Executive Order 12866.
This action does not impose any enforceable duty, or contain any
``unfunded mandates'' as described in Title II of the Unfunded Mandates
Reform Act of 1995 (Pub. L. 104-4), or require prior consultation as
specified by Executive Order 12875 (58 FR 58093, October 28, 1993),
entitled Enhancing the Intergovernmental Partnership, or special
consideration as required by Executive Order 12898 (59 FR 7629,
February 16, 1994).
Pursuant to the requirements of the Regulatory Flexibility Act (5
U.S.C. 601-612), the Administrator has determined that regulations
establishing new inert ingredient 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 explaining the factual basis for
this determination 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, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: July 5, 1996.
Peter Caulkins,
Acting Director, Registration Division, 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 180.1168 is added to subpart D to read as follows:
Sec. 180.1168 Polybutene; exemption from the requirement of a
tolerance.
A time-limited exemption from the requirement of a tolerance is
established for residues of polybutene (CAS Reg. No. 9003-29-6),
molecular weight (in amu) 320 or greater, not to exceed 35 percent of
the pesticide formulation when used as an inert ingredient (sticker and
spreading agent) in pesticide formulations applied to growing crops
only. This time-limited exemption from the requirement of a tolerance
will expire on April 26, 1999.
[FR Doc. 96-18391 Filed 7-23-96; 8:45 am]
BILLING CODE 6560-50-F
