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Reclassification of List 3 Inerts to List 4B 6/95


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: 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, [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: 
waller.mary@epamail.epa.gov. 

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
------------------------------------------------------------------------ 
CAS Reg. No.	Chemical name
------------------------------------------------------------------------

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
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
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, methylpolymer 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, ethoxylate

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-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.

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