[Federal Register Volume 60, Number 130 (Friday, July 7, 1995)]
[Notices]
[Pages 35396-35399]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-16556]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-36140C; FRL-4957-9]
Inert Ingredients in Pesticide Products; Reclassification of
Certain List 3 Inert Ingredients to List 4B
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: EPA is issuing a list of inert ingredients formerly considered
to be inert ingredients of unknown toxicity (List 3) for which it now
has sufficient information to conclude that their current use patterns
in pesticide products will not adversely affect public health and the
environment and can therefore be reclassified to List 4B.
EFFECTIVE DATE: July 7, 1995.
ADDRESSES: By mail, submit written comments identified by the document
control number 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 Bldg. #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 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: [email protected]. 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, [OPP-36140C]. 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: Mary Waller, Registration
Support Branch, Registration Division (7505W), Environmental Protection
Agency, 401 M St. SW., Washington, DC 20460. Office location and
telephone number: 2800 Crystal Drive, 6th Floor, Arlington, VA 22202,
(703)-308-8811; e-mail: [email protected].
SUPPLEMENTARY INFORMATION: EPA announced its policy on toxic inert
ingredients in pesticide products in the Federal Register of April 22,
1987 (52 FR 13305). Through its policy, EPA encourages the use of the
least toxic inert ingredients available and requires the development of
data necessary to determine the conditions of safe use of products that
contain toxic inert ingredients. In developing this policy, EPA
categorized inert ingredients into the following four lists according
to toxicity:
List 1--Inerts of toxicological concern.
List 2--Potentially toxic inerts, with high priority for testing.
List 3--Inerts of unknown toxicity.
List 4--Inerts of minimal concern.
In the Federal Register of November 22, 1989 (58 FR 48314), EPA
issued a
[[Page 35397]]
notice announcing some modifications to the previously published Lists
1 and 2. In that notice, EPA also noted that List 4 was being divided
into two parts. The original List 4 became List 4A, representing
minimal risk inert ingredients. List 4B was created to represent inert
ingredients for which EPA has sufficient information to conclude that
their current use patterns in pesticide products will not adversely
affect public health and the environment. EPA subsequently issued List
4A in the Federal Register of September 28, 1994 (59 FR 49400).
As a part of its initial review of the inert ingredients originally
categorized as List 3, EPA has identified 146 inert ingredients that
merit reclassification to List 4B. The basis for this reclassification
is as follows:
1. On behalf of the Office of Pesticide Programs, these substances
were reviewed by the Structure Activity Team of EPA's Office of
Pollution Prevention and Toxics with each judged to be of low concern
for potential human health and/or environmental effects.
2. Each of these substances is either approved for use by the U.S.
Food and Drug Administration as (a) a direct food additive under 40 CFR
part 172 or (b) a polymer considered to not present an unreasonable
risk on the basis of its conformance with the criteria given in the
polymer exemption rule at 40 CFR 723.250. The polymer exemption rule
exempts selected low-risk polymers from part or all of the
premanufacture notification provisions of section 5 of the Toxic
Substances Control Act (TSCA).
3. These inert ingredients were evaluated by the Office of
Pesticide Program's Inert Review Group and determined to be of minimal
risk.
A list of these inert ingredients proposed for reclassification was
provided to EPA's Office of Water and to FDA's Center for Food Safety
and Applied Nutrition for comment; no adverse comments were received.
This reclassification is expected to be the first in a series of
actions related to the disposition of inert ingredients currently on
Lists 2 and 3. EPA is continuing its review of other List 2 and List 3
inert ingredients under the inerts strategy and, following its
assessment, will make further determinations regarding inert ingredient
categorization.
List 4B.--Inert Ingredients
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CAS Reg. No. Chemical name
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57-55-6..................... Propylene glycol
67-63-0..................... Isopropyl alcohol
71-36-3..................... 1-Butanol
80-56-8..................... alpha-Pinene
91-53-2..................... ethoxyquin
94-13-3..................... Propyl p-hydroxybenzoate
98-86-2..................... Acetophenone
99-76-3..................... Methyl p-hydroxybenzoate
102-76-1.................... Glyceryl triacetate
106-97-8.................... n-Butane
111-27-3.................... 1-Hexanol
111-70-6.................... 1-Heptanol
112-30-1.................... 1-Decanol
120-72-9.................... 1H-Indole
123-95-5.................... Butyl stearate
124-07-2.................... Octanoic acid
124-10-7.................... Methyl tetradecanoate
139-44-6.................... Glyceryltris (12-hydroxystearate)
141-78-6.................... Ethyl acetate
151-21-3.................... Dodecyl sulfate, sodium salt
527-07-1.................... Gluconic acid, sodium salt
527-09-3.................... Cupric gluconate
533-96-0.................... Sodium sesquicarbonate
860-22-0.................... FD & C Blue No. 2
868-18-8.................... Sodium tartrate
1302-42-7................... Sodium aluminate
1310-58-3................... Potassium hydroxide
1310-73-2................... Sodium hydroxide
1338-41-6................... Sorbitan monostearate
1343-98-2................... Silicic acid
7558-79-4................... Disodium phosphate
7722-88-5................... Diphosphoric acid, tetrasodium salt
7722-88-5................... Tetrasodium pyrophosphate
7664-93-9................... Sulfuric acid
7758-16-9................... Sodium acid pyrophosphate
7784-25-0................... Aluminum ammonium sulfate
7785-87-7................... Manganese sulfate
8009-03-8................... Petrolatum
8015-86-9................... Carnauba wax
8050-33-7................... Polyoxyethylene ester of rosin
8061-51-6................... Lignosulfonic acid, sodium salt
8061-52-7................... Lignosulfonic acid, calcium salt
9002-89-5................... Polyvinyl alcohol
9002-92-0................... Polyoxyethylene dodecyl mono ether
9003-06-9................... Acrylamide-acrylic acid resin
9003-07-0................... Polypropylene
9003-11-6................... Polyoxyethylene-polyoxypropylene copolymer
[[Page 35398]]
9003-49-0................... Polymerized butyl acrylate
9003-55-8................... Butadiene-styrene copolymer
9004-62-0................... 2-Hydroxyethyl cellulose
9004-64-2................... Cellulose, 2-hydroxypropyl ether
9004-65-3................... 2-Hydroxypropyl methyl cellulose
9004-67-5................... Methyl cellulose
9004-81-3................... Polyoxyethylene monolaurate
9004-82-4................... Dodecanol, ethoxylated, monoether with
sulfuric acid, sodium salt
9004-95-9................... Polyoxyethylene monohexadecyl ether
9004-96-0................... Polyoxyethylene monooleate
9004-98-2................... Polyoxyethylene mono(cis-9-octadecenyl)
ether
9004-99-3................... Polyoxyethylene monostearate
9005-00-9................... Polyoxyethylene monooctadecyl ether
9005-07-6................... Polyoxyethylene dioleate
9005-08-7................... Polyoxyethylene distearate
9005-37-2................... Propylene glycol alginate
9005-64-5................... Polyoxyethylene sorbitan monolaurate
9005-65-6................... Polyoxyethylene sorbitan monooleate
9005-66-7................... Polyoxyethylene sorbitan monopalmitate
9005-67-8................... Polyoxyethylene sorbitan monostearate
9005-70-3................... Polyoxyethylene sorbitan trioleate
9005-71-4................... Polyoxyethylene sorbitan tristearate
9007-48-1................... Polyglycerol ester of oleic acid
9011-14-7................... Polymethyl methacrylate
9011-29-4................... Polyoxyethylene sorbitol hexastearate
9014-85-1................... Polyethylene glycol ether with ether with
1,4-diisobutyl-1,4-dimethylbutynediol
(2:1)
9014-90-8................... Nonylphenol, ethoxylated, monoether with
sulfuric acid, sodium salt
9014-92-0................... Polyoxyethylene dodecylphenol
9014-93-1................... Polyoxyethylene dinonylphenol
9016-45-9................... Polyoxyethylene nonylphenol
9036-19-5................... Polyoxyethylene (1,1,3,3-tetramethylbutyl)
phenyl ether
9038-29-3................... Oxirane, methyl-, polymer with oxirane,
decyl ether
9038-95-3................... Polyethylene-polypropylene glycol,
monobutyl ether
9081-17-8................... Nonylphenol, ethoxylated, monoether with
sulfuric acid
9084-06-4................... Naphthalenesulfonic acid, polymer with
formaldehyde, sodium salt
10124-56-8.................. Sodium hexametaphosphate
12173-47-6.................. Hectorite
25231-21-4.................. Polyoxypropylene monostearyl ether
25322-68-3.................. Polyethylene glycol
25322-69-4.................. Polypropylene glycol
25496-72-4.................. Glyceryl monooleate
25719-52-2.................. Dodecyl 2-methylacrylate polymer
25719-60-2.................. beta-Pinene homopolymer
26027-38-3.................. p-Nonylphenol, ethoxylated
26183-44-8.................. Dodecyl alcohol, ethoxylated, monoether
with sulfuric acid
26183-52-8.................. Polyoxyethylene monodecyl ether
26266-57-9.................. Sorbitan monohexadecanoate
26635-76-7.................. Glycols, polyethylene, mono(oleylamines)-
ethyl ester
26636-39-5.................. Polyoxyethylene monoeicosyl ether
26636-40-8.................. Polyoxyethylene docosyl ether
26915-70-8.................. Tridecanol, ethoxylated, phosphate ester
27306-79-2.................. Polyoxyethylene monotetradecyl ether
31566-31-1.................. Glyceryl monostearate
31800-88-1.................. Octyloxypoly(ethyleneoxy)ethyl phosphate
37280-82-3.................. Polyoxyethylene polyoxypropylene phosphate
37286-64-9.................. Polyoxypropylene monomethyl ether
37340-60-6.................. Nonylphenol, ethoxylated, phosphate ester,
sodium salt
39464-64-7.................. Dinonylphenol, ethoxylated, phosphated
41928-09-0.................. Polyethylene glycol ether with 2,2'-
methylenebis(4-(tert-octyl)phenol) (2:1)
50769-39-6.................. Butylpolyethoxyethanol esters of
phosphoric acid
51609-41-7.................. 4-Nonylphenol, ethoxylated, phosphate
ester
51617-79-9.................. Polyoxyethylene octadecylphenol
51811-79-1.................. Nonylphenol, ethoxylated, phosphate ester
52503-15-8.................. Polyethylene glycol nonylphenyl ether
phosphate potassium salt
54116-08-4.................. Sodium tridecylpoly(oxyethylene) sulfate
55069-68-6.................. Polyethylene glycol hexaether with
sorbitol, diester with dodecanoic and
oleic acids
56388-96-6.................. Poly(oxyethylene)tridecylacetic acid
57171-56-9.................. Polyoxyethylene sorbitol hexaoleate
57451-03-3.................. Nonylphenol, ethoxylated, monoether with
sulfuric acid, triethanolamine salt
59139-23-0.................. Polyethylene glycol nonylphenyl ether
phosphate ethanolamine salt
60828-78-6.................. 2,6,8-Trimethyl-4-nonylpolyethylene glycol
ether
60864-33-7.................. Benzyl ether of 1,1,3,3-tetramethylbutyl
phenoxypolyethoxy ethanol
[[Page 35399]]
60874-89-7.................. Polyethylene glycol ether with
methylenebis(diamylphenol)
61725-89-1.................. Oxirane methyl-, polymer with oxirane,
tridecyl ether
61788-60-1.................. Methyl esters of cottonseed oil
61790-90-7.................. Fatty acids, tall-oil, hexaester with
sorbitol, ethoxylated
61791-12-6.................. Castor oil, ethoxylated
61791-23-9.................. Soybean oil, ethoxylated
61791-26-2.................. Polyethoxylated tallowamine
61827-84-7.................. Oxirane, methyl-, polymer with oxirane,
octyl ether
63089-86-1.................. Polyoxyethylene sorbitol tetraoleate
63393-89-5.................. Coumarone - indene resin
64754-90-1.................. Chlorinated polyethylene
66070-87-9.................. Polyglyceryl phthalate ester of coconut
oil fatty acid
67922-57-0.................. Polyethylene glycol nonylphenyl ether
phosphate magnesium salt
68131-40-8.................. Alcohols, C12-15, polyethoxylated
68187-71-3.................. Calcium salts of tall-oil fatty acids
68333-69-7.................. Rosin, maleated, polymer with
pentaerythritol
68425-44-5.................. Amides, coco, N-(hydroxyethyl),
ethoxylated
68441-17-8.................. Oxidized polyethylene
68458-49-1.................. Polyphosphoric acids, esters with
polyethylene glycol nonylphenyl ether
68526-94-3.................. Alcohols, C12-20, ethoxylated
68646-20-4.................. Sorbitol tall oil fatty acid sesquiester,
ethoxylated
68650-09-9.................. Fatty acids, tall-oil, mixed esters with
glycerol and polyethylene glycol
68891-29-2.................. Alcohols, C8-10, ethoxylated, monoether
with sulfuric acid, ammonium salt
69227-21-0.................. Alcohols, C12-18, ethoxylated propoxylated
70632-06-3.................. Alcohols, C12-15, ethoxylated,
carboxylated, sodium salts
71012-10-7.................. Oleic acid, 2-(2-(2-(2-hydroxyethoxy)eth
oxy)ethoxy)ethyl ester
97043-91-9.................. Alcohols, C9-16, ethoxylated
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A record has been established for this rulemaking under docket
number [OPP-36140C] (including any 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-D[email protected]
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.
List of Subjects
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping.
Dated: June 23, 1995.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 95-16556 Filed 7-6-95; 8:45 am]
BILLING CODE 6560-50-F