[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] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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