[Federal Register Volume 60, Number 189 (Friday, September 29, 1995)]
[Proposed Rules]
[Pages 50514-50516]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-24280]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 5E4540/P633; FRL-4977-8]
RIN 2070-AC18
-Alkyl (C21-C71)--
Hydroxypoly(Oxyethylene); Tolerance Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: This document proposes that residues of -alkyl
(C21-C71)--hydroxypoly(oxyethylene) be exempted
from the requirement of a tolerance when used at levels not to exceed
10% as a wetting agent or granule coating in pesticide formulations.
Petrolite Corp. requested this regulation under the Federal Food, Drug
and Cosmetic Act (FFDCA).
DATES: Comments, identified by the document control number [PP 5E4540/
P633], must be received on or before October 30, 1995.
ADDRESSES: By mail, submit written comments to: Public Response and
Program Resources Branch, Field 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, Building #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202.
Information submitted as a comment concerning this document may be
claimed confidential by marking any part of 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 the 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 in 5.1 file format or ASCII file
format. All comments and data in electronic form must be identified by
the docket number [PP 5E4540/P633]. No Confidential Business
Information (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: Amelia M. Acierto,
Registration Support Branch, Registration Division (7505W), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. Office location and telephone number: 2800
Crystal Drive, North Tower, Arlington, VA 22202, (703)-308-8375; e-
mail: acierto.amelia@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: Petrolite Corp., Polymers Division, 6910
East 14th St., Tulsa, OK 74112, submitted pesticide petition (PP)
5E4540 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 -alkyl (C21-C71)-
-hydroxypoly(oxyethylene) when used at levels not to exceed
10% as a wetting agent or granule coating 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
these 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 Agency has decided that no
data, in addition to that described below, for -alkyl
(C21-C71)--hydroxypoly(oxyethylene) will need to be
submitted. The rationale for this decision is described below:
1. The rat acute oral toxicity studies with acute oral LD50
values varying from 410 mg/kg to 25,000 mg/kg.
2. The acute dermal toxicity studies with acute dermal LD50
values from 930 mg/kg to 11,800 mg/kg in rabbits and > 2,000 mg/kg in
rats.
3. Mutagenicity studies including Salmonella typhimurium plate
(Ames) tests with and without activation, structural chromosomal
aberration test and other genotoxic effects tests were negative.
4. The 90-day feeding toxicity study in rats with a NOEL 15 mg/kg/
day.
[[Page 50515]]
5. The 90-day dermal toxicity study with a NOEL of 20 mg/kg/day in
rabbits and greater than 125 mg/kg/day in rats.
6. The developmental toxicity study in rabbits with a systemic
maternal NOEL of 50 mg/kg/day and a developmental NOEL of > 200 mg/kg/
day indicating no evidence of developmental effects.
7. The rat reproductive toxicity study with the systemic and
developmental NOEL of 50 mg/kg/day and reproductive NOEL of > 250 mg/
kg/day indicating no evidence of reproductive effects.
8. The rat chronic and carcinogenicity study with systemic NOEL of
50 mg/kg/day showing no evidence of carcinogenicity effects.
Based upon the above evaluation of the toxicological data which
shows no evidence of carcinogenicity, mutagenicity (Ames Test), acute
and subchronic dermal, developmental or reproductive toxicity of
-alkyl (C21-C71)--hydroxypoly
(oxyethylene) and the expected dietary exposure, the Agency concludes
that this chemical poses no significant risks under the proposed
conditions of use and that no further data are required. In addition,
these chemicals are similar to other ethoxylated alcohols [C12-15-
polyethoxylated alcohols (CAS # 68131-40-8), C12-20-ethoxylated
alcohols (CAS # 68526-94-3) and C12-18-ethoxylated-propoxylated
alcohol (CAS # 69227-21-0)], which have already been exempted from the
requirement of a tolerance under 40 CFR 180.1001(c) or (d) based on
data indicating no adverse toxicological effects. Furthermore, these
chemicals are among those that the Agency has sufficient information to
conclude that their current use patterns in pesticide products will not
adversely affect public health and the environment and which have
subsequently been reclassified from List 3 (inert ingredients of
unknown toxicity) to List 4b (inert ingredients of minimal concern) (60
FR 35396, July 7, 1995). The -alkyl (C21-C71)-
-hydroxypoly(oxyethylene) merely have a longer carbon chain,
and the expected breakdown products are similar to the shorter extant
ethoxylated alcohols. There is no reason to believe that there would be
any toxicological concern for the longer carbon chain-length alcohols
since these would most likely result in decreased absorption and
toxicity. Furthermore, similar surfactants, i.e., ethoxylated fatty
acids and their salts and esters, ethoxylated polyglycols, ethoxylated
amines, and others, are presently exempted from tolerances under 40 CFR
180.1001.
Based upon the information above, the toxicological data and
physico-chemical properties of -alkyl (C21-C71)-
-hydroxypoly(oxyethylene), and review of its use, the Agency
has found that, when used in accordance with good agricultural
practice, this 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.
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 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, [PP 5E4540/P633]. All written comments filed
in response to this petition will be available in the Public Response
and Program Resources Branch, at the address given above from 8 a.m. to
4:30 p.m. Monday through Friday, except legal holidays.
A record has been established for this rulemaking under docket
number [PP 5E4540/P633] (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 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, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: September 19, 1995.
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 180.1001(d) is amended in the table therein by adding
and alphabetically inserting the inert ingredient, to read as follows:
Sec. 180.1001 Exemptions from the requirement of a tolerance.
* * * * *
(d) * * *
[[Page 50516]]
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Inert ingredients Limits Uses
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* * * * * * *
-Alkyl (C21-C71)- Not to exceed 10%. Wetting agent or granule
-hydroxypoly coating
(oxyethylene) in which
the poly(oxyethylene)
content is 2 to 91 moles
and molecular weight
range from 390 to 5,000.
* * * * * * *
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[FR Doc. 95-24280 Filed 9-27-95; 9:10 am]
BILLING CODE 6560-50-F
