[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                      
------------------------------------------------------------------------
        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

[[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              
------------------------------------------------------------------------



     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