f/EPA United States Environmental Protection Agency Uttice ot Toxic Substances Washington DC 20460 June 1984 Volume 1 Number 1 Chemical Control in the United States: Accomplishments under the Premanufacture Notice Management Program CH CH CH ------- JUNE 1984 CHEMICAL CONTROL IN THE UNITED STATES) ACCOMPLISHMENTS UNDER THE PREMANUFACTURE NOTICE MANAGEMENT PROGRAM OFFICE OF TOXIC SUBSTANCES U.S. ENVIRONMENTAL PROTECTION AGENCY ------- ACKNOWLEDGMENTS Wendy Cleland-Hamnett Rebecca Torchia Alison Kerester Jon Silberman Breck Milroy Carl Mazza James Nelson Richard Green R. James Alwood Rose Allison Lynda Garland Joseph Boyle Stephanie Roan Anna Coutlakis Daniel Dickson Mary Cushmac Robert Jones Paul Matthai June Thompson Melvin Quick Jane Talarico David Bottimore Cover design by Paul Bickart, Ph.D., Office of Toxic Substances ------- TABLE OF CONTENTS Page Introduction i Preface iii Overview of PMN Program Action 1 A. Formal Regulatory Actions Under TSCA, Section 5 1. Section 5(f) Rules 3 2. Unilateral Section 5(e) Orders 7 3. Section 5(e) Consent Orders 13 4. Modifications of Section 5(e) Orders 21 B. Informal Regulatory Actions Under TSCA, Section 5 1. Voluntary Testing 25 2. Voluntary Controls 37 C. Withdrawal of PMNs 1. Prior to Likely Section 5(e) Action 49 2. Prior to Likely Section 5(f) Action 61 LIST OF TABLES 1. Annual Compilation of PMN Program Actions 67 2. Percentage of Commencement of Manufacture Notices Received 68 3. Annual Compilation of PMN Program Activities FY 1980 - FY 1984 69 4. Historical Compilation of Specific Concerns Underlying Formal and Informal Regulatory Actions Domestic U.S. Import Chemicals 74 5. Fiscal Year Graph of Valid PMNs Received 75 6. Comparison of Domestic vs. Imported PMNs Received 75 ------- INTRODUCTION In recent years, many nations have instituted programs to review the hazards presented by chemical substances before they are introduced into commerce. Under these programs the hazards of such chemicals can be controlled before harm to human health or the environment occurs. These national programs have been assisted in their development by the work of the Organization for Economic Co- operation and Development (OECD) which has conducted an active program in promoting common approaches to chemical control within member nations. Among the objectives of the OECD Chemicals Program is the exchange of information and experience gained in the implementation of national programs. This report provides the first annual summary of actions taken under the United States new chemical program which is mandated by the Toxic Substances Control Act (TSCA). EPA believes that the dissemination of such information internationally will assist in developing better understanding of the U.S. new chemical program and may be of use to other nations involved in similar programs. Don R. Clay, Director Office of Toxic Substances -i- ------- PREFACE In authorizing the Toxic Substances Control Act (TSCA), (15 USC 2601 et seq.), Congress recognized that health and environmental considerations are more easily addressed before, rather than after, a chemical is manufactured and introduced into commerce. Section 5 of TSCA mandates the Environmental Protection Agency (EPA) to review the potential effects of new chemicals prior to manufacture or import. For purposes of this premanufacture review, any chemical not included in the TSCA Inventory of Chemical Substances, is considered "new". The Inventory is regularly updated by the Agency to include newly manufactured or imported chemicals. In addition, TSCA authorizes premanufacture review of "significant new uses" of existing chemicals, as may be defined by rule at the discretion of the EPA Administrator. In either instance, manufacturers and importers are required to submit to EPA 90-day advance notification of intent to manufacture, process, or import a new chemical substance, or an existing chemical substance for a designated significant new use. The Administrator may, for good cause, extend the 90-day premanufacture review period for an additional 90 days. In order to meet the statutory mandate of TSCA Section 5, the Agency has developed the Premanufacture Notice (PMN) Review Program. The purpose of the Program is to determine, before a new chemical enters commerce, whether proposed uses of the PMN substance may result in an unreasonable risk of injury to health or the environment. To enable EPA to conduct its review, PMN submitters must include the following information: the name of the chemical, its chemical identity, and molecular structure; proposed categories of use; an estimate of the amount to be manufactured; the by-products resulting from the manufacture, processing, and disposal of the chemical; exposure and release information; and any test data in the manufacturer's possession related to health and environmental effects. In addition, if a rule requiring testing of the chemical has been promulgated under TSCA section 4, the manufacturer must conduct the testing before submitting the notice and must submit data developed from that testing. With respect to chemicals subject to such testing rules, the Administrator must either initiate regulatory action under TSCA sections 5, 6, or 7, or publish in the FEDERAL REGISTER a statement of reasons such regulatory action is not being initiated. The same requirement applies to chemicals previously listed by the Administrator under TSCA section 5(b)(4) as potentially presenting an unreasonable risk, and to any use that has been designated by rule under TSCA section 5(a)(2) as a significant new use. -111- ------- Since the beginning of its program, July 1979, EPA has received and reviewed increasing numbers of PMNs each fiscal year (FY) [NOTE: A fiscal year begins on October 1st of the preceding calendar year.] In FY 1983, for example, 1301 PMNs were received, as compared with 281 in FY 1980. Most PMNs reviewed do not warrant regulatory action. In many cases however, the Agency has taken measures to obtain additional data from submitters or has acted to control exposure to substances which are suspected of presenting an undue hazard. Some of these measures include formal regulatory actions, such as TSCA section 5(e) orders; other informal measures involve negotiations with PMN submitters and include voluntary testing or controls. This report, the first of an ongoing series of annual PMN program activity reports, represents a complete compilation of major actions taken by the Agency in response to PMN submissions. it provides an overview of completed actions, both formal and informal, from the inception of the PMN program through June 30, 1984. In addition, a tabular breakdown is provided of particular toxicity concerns raised by PMN reviews, with reference to the exposed populations of concern. This overview is supplemented by detailed information on individual PMNs. Questions or comments on this report should be directed to Margaret Stasikowski, Director, Chemical Control Division (TS- 794), Environmental Protection Agency, 401 M Street, S.W., Washington, D.C. 20460. For additional copies of this report— Write: TSCA Assistance Office Office of Toxic Substances (TS-799) U.S. Environmental Protection Agency 401 M Street, S.W. Washington, D.C. 20460 Call: Toll Free 800-424-9065 In Washington, D.C. 202-554-1404 -iv- ------- OVERVIEW OF PMN REVIEW PROGRAM ACTION In the event that potential health or environmental concerns are identified during premanufacture review, EPA may find that additional data are necessary to determine whether proposed uses of a chemical will present an unreasonable risk of injury to health or the environment. In such cases, the Agency may prohibit or limit manufacture of the chemical under TSCA §5(e) pending development, by the submitter, of the necessary data. In some circumstances, the Agency may permit production with certain conditions, such as the use of protective equipment and/or engineering controls pending development of such test data, and may negotiate such protective measures with the PMN submitter. When serious health or ecological effects are indicated by existing data, the Agency may simply prohibit the manufacture, processing, or use of the substance or otherwise limit such activities under the provisions of TSCA §5(f). Alternatively, the Agency may pursue informal courses of action through negotiations with PMN submitters to obtain additional test data or appropriate limitations on manufacture, processing, distribution in commerce, use, or disposal. Sections A and B below briefly describe the various formal and informal mechanisms by which EPA may address concerns raised during premanufacture review. Formal actions under TSCA are discussed in order of decreasing regulatory stringency, beginning with section 5(f) orders. Section C discusses a third possible outcome of concerns raised during premanufacture review: withdrawal by the submitter of the PMN from the review process. A. Formal Section 5 Regulatory Actions 1. Section 5(f) Orders or Rules. Under TSCA section 5(f), the Agency may issue a proposed order prohibiting the activities described in the PMN if it finds that there is a reasonable basis to conclude that the PMN substance will present an unreasonable risk of injury to human health or the environment. Alternatively, EPA may, upon the same finding, issue a proposed rule limiting the activities described in the PMN. Such a proposed rule is effective immediately upon its publication in the FEDERAL REGISTER. 2. Unilateral Section 5(e) Orders. EPA may issue a proposed section 5(e) Order if the Agency determines that, 1) the information available is insufficient to permit a reasoned evaluation of the health and environmental effects of the PMN substance, and 2) in the absence of such information, the activities described in the PMN may present an unreasonable risk, or 3) that the substance is or will be produced in substantial quantities, and either enters or may enter the environment in substantial quantities or may result in significant or substantial —l — ------- human exposure. The terms of the order can prohibit or limit the manufacture, processing, distribution in commerce, use, or disposal of the substance. 3. Section 5(e) Consent Orders. Section 5(e) Consent Orders are mutuallyagreed upon by the PMN submitter and EPA, and require the same findings as those for a Unilateral Order described above. They specify requirements to limit exposure or environmental release, and sometimes reflect negotiated testing. B. Informal Regulatory Actions Under Section 5 1. Voluntary Testing. EPA frequently identifies a potential unreasonable risk concern that can be addressed through testing the substance. In such cases, the submitter may request a suspension of the notice review period and voluntarily test the PMN substance using a mutually agreed upon protocol. EPA then evaluates the test results to determine whether the data nullify or confirm the Agency's concern. The significance of the risk would determine whether additional regulatory action is necessary. 2. Voluntary Controls. Occasionally, EPA identifies a potentially unreasonable risk with respect to one or more of the activities described in the PMN that can be readily addressed through some form of voluntary control. Such controls may involve limiting the manufacture of the substance to one physical form, modifying the labeling or Material Safety Data Sheet (MSDS) to inform potentially exposed persons of the concern, or other measures. In these cases, the Agency and the PMN submitter may agree to amend the original PMN so that controls are specified that resolve EPA's concerns. EPA would then take no formal regulatory action against the substance under TSCA section 5 for the activities described in the amended PMN. EPA has restricted use of voluntary controls to certain situations where enforceable controls are not warranted. C. Withdrawal of PMNs A PMN submitter may withdraw a PMN from review at any time. Certain PMN submitters have chosen to do this when EPA has identified potential unreasonable risks with respect to the activities described in the PMN. EPA would otherwise address such risk through either an informal or formal regulatory action. Once a PMN is withdrawn, the manufacturer or importer must submit another notice, which is subject to another 90-day review period, before manufacture or import can begin. -2- ------- PART A. FORMAL REGULATORY ACTIONS 1. SECTION 5(£) RULES -3- ------- SECTION 5(f) RULES P83-1005, 83-1062 IMPORT Chemical Name: P83-1005 - Polycarboxylic Acid, Alkanolamine Salt Chemical Name: P83-1062 - Polycarboxylic Acid Concerns were raised for potential carcinogenicity during product use for workers from the addition of nitrites to the PMN substance. EPA issued a section 6(a) rule under TSCA, made immediately effective under section 5(f) on January 23, 1984. The action required notification to consumers and labeling to prevent the addition of nitrites and/or other nitrosating agents to the substance. 84-310 IMPORT Chemical Name: Amine Salt of a Substituted Organic Acid A section 5(f) Rule was signed on June 7, 1984 by the EPA Administrator. The PMN substance raised concern for carcinogenicity associated with exposure in the workplace and during use. The Rule included warnings to processors and users in the forms of letters and labels as well as instructions to avoid the addition of nitrates or other nitrosating agents. -5- ------- PART A. FORMAL REGULATORY ACTIONS 2. Unilateral Section 5(e) Orders -7- ------- UNILATERAL SECTION 5(e) ORDERS P79-21, 22, 23, 24, 25, 26 DOMESTIC Chemical Name: P79-21 - Polymer of Phthalic Anhydride, Ethylene Glycol, Heptanol, and 2-Ethylhexanol P79-22 - Polymer of Phthalic Anhydride, 1,2- Propylene Glycol, 1,4-Butanediol, 1-Octanol, and 1-Decanol P79-23 - Polymer of Phthalic Anhydride, Ethylene Glycol, Heptanol, 1-Octanol, and 1-Decanol P79-24 - Polymer of Phthalic Anhydride, 1,2- Butanediol, and 2-Ethylhexanol P79-25 - Polymer of Phthalic Anhydride, 1,3- Butylene Glycol, 1-Octanol, 1-Decanol P79-26 - Polymer of Phthalic Anhydride, 1,3- Butylene Glycol, and 2-Ethylhexanol Additional information associated with these PMN substances was required by the Agency to properly address potential carcinogenicity concerns if workers are exposed during manufacture and processing. Aquatic toxicity was another concern related to these chemicals. Manufacture of the PMN substance was prohibited on April 25, 1980 pending submission of additional information to address these concerns. These chemicals were subsequently withdrawn with no further testing data submitted. P80-35 DOMESTIC Chemical Name: Substituted Phenol, reactive products with C22-30 Alkenes Concerns were raised for potential dermal sensitization if workers are exposed during manufacture and processing, and if consumers are exposed during use of the final product. EPA issued a Unilateral section 5(e) Order on September 5, 1980 which prohibited manufacture of the PMN substance pending submission of additional information to address the noted concerns. -9- ------- UNILATERAL SECTION 5(e) ORDERS P80-356, 357 IMPORT Chemical Name: P80-356 - Benzole Acid, 2-[[2-Amino-5-Hydroxy-6- [[4'-[[l-Hydroxy-8-[ [4- Methylphenyl)Sulfonyl]Ami no]-3,6-Disulfo-2- Naphthalenyl] Azo]-3,3'-Dimethoxy[1,1'- Biphenyl]-4-yl]Azo]-7-Sulfo-l-Naphthalenyl] Azo-5-Nitro-, Trisodium Salt P80-357 - Benzoic Acid, 2-[[2-Amino-6-[[4'-[2,5- Disulfophenyl Azo]-l-Hydroxy-6-(Phenylamino)-3- Sulfo-2-Naphthalenyl]Azo]-3,3'-Dimethoxy[1, 1'- Biphenyl]-4-yl] Azo]-5-Hydroxy-7-Sulfo-l- Naphthalenyl]-Azo]-5-Nitro-,Tetrasodium Salt A Unilateral section 5(e) Order was issued on October 9, 1981. The action prohibited importation of the substances pending submission of test data to address the Agency's carcinogenicity concerns of workers exposed during processing as well as of the general public exposed by contaminated drinking water. The Company chose to withdraw the chemicals. P82-678, 679 IMPORT Chemical Name: P82-678 - Chlorinated Aromatic Azo Anthraquinone Pigment P82-679 - Chlorinated Aromatic Azo Pigment An in vitro test protocol submitted by the Company was found to be inadequate by the Agency to address carcinogenicity concerns. Therefore a Unilateral section 5(e) Order was issued. The Order recommends in vivo metabolism or other appropriate testing of these chemicals. The Company declined to conduct an in vivo test and withdrew the PMNs. -10- ------- UNILATERAL SECTION 5(e) ORDERS P83-401, 418 IMPORT Chemical Name: P83-401 - Naphthalene Trisulfonic Acid, Chlorotriaziny1amino-MethoxymethyIphenylazo P83-418 - Benzene Disulfonic Acid, Chlorotriazinylamino Dimethyl Phenylazo- Sulfonaphthalene Azo This Unilateral section 5(e) Order was delivered to the submitter; however, a suspension was granted during the comment period so that the submitter could address carcinogenicity concerns associated with exposure to workers and to the general public via contaminated drinking water. P83-663 IMPORT Chemical Name: Alkyl-substituted Aromatic Amine EPA prohibited importation of the PMN substance pending submission of additional information to address carcinogenicity concerns. The Unilateral section 5(e) Order was issued on November 16, 1983 to protect workers exposed during processing and use. The PMN was subsequently withdrawn. -11- ------- PART A. FORMAL REGULATORY ACTIONS 3. SECTION 5(e) CONSENT ORDERS -13- ------- SECTION 5(e) CONSENT ORDERS P82-400, 409 DOMESTIC Chemical Name: P82-400 - Potassium N, N-bis (Hydroxyethyl) Cocoamine Oxide Phosphate P82-409 - Potassium N, N-bis (Hydroxyethyl) Tallow Amine Oxide Phosphate The Company and EPA signed a section 5(e) Consent Order limiting production of the chemicals to non-consumer use. This Order prohibits the Company from processing and distributing the PMN chemicals to consumer product formulators pending further testing at concentrations in formulations which would be representative of consumer products. A Significant New Use Rule (SNUR) is now being prepared which will require any person to submit a new PMN to the Agency for any consumer use of these chemicals. For this particular case, as soon as the SNUR is promulgated, the 5(e) Consent Order will be automatically revoked. P82-684 DOMESTIC Chemical Name: Halogenated Hydrocarbon A section 5(e) Consent Order was negotiated with the Company following concern for potentially significant carcinogenic risks to workers during manufacture and processing of the PMN substance. The Order established controls during portions of manufacture and processing of the chemical. -15- ------- SECTION 5(e) CONSENT ORDERS P83-23, 24, 49, 75, 272 DOMESTIC Chemical Name: P83-23 - Substituted Phenol P83-24 - Substituted Pyridine P83-49 - Substituted Pyridine I P83-75 - Sodium 2-substituted Propanoate P83-272 - Substituted Pyridine This section 5(e) Consent Order of March 9, 1983 requires use of dermal protection for all of the substances, and positive pressure, full facepiece air-supplied respirators for two of the chemicals, pending information sufficient to assess the risks posed. Concerns arose for liver and kidney toxicity, and central nervous system depression if workers are exposed during manufacture and processing. P83-129 through 235 DOMESTIC Chemical Name: Syncrude (Full range dewaxed dearsinated Shale Oil) A section 5(e) Consent Order was drafted to address carcinogenicity concerns associated with these synfuels and their potentially hazardous wastes. It requires the Company to use special worker protection equipment during the upgrading process, as well as placing stringent controls on hazardous solid wastes. The Order went into effect on May 25, 1983. P83-237 DOMESTIC Chemical Name: Substituted Pyridine On April 4, 1983, a section 5(e) Consent Order was signed by the Agency. The Order requires the use of safety equipment and processing controls at manufacture and processing sites. These actions were taken because of concerns for potential liver and kidney effects to workers. -16- ------- SECTION 5(e) CONSENT ORDERS P83-255 IMPORT Chemical Name: Dicarboxylic Acid Monoester The Agency was concerned about worker exposure during processing, the use of the PMN substance, and the substance's potential teratogenicity and reproductive effects. The section 5(e) Consent Order, requiring worker protective equipment and labeling, was signed April 8, 1983. P83-370 IMPORT Chemical Name: 8-Acetyl-3-Dodecyl-7,7,9,9-Tetramethyl-l,3,8- Triazaspiro [4,5] Decane-2,4-Dione Based on test data submitted with the PMN, both the Agency and the Company concluded that the PMN substance is a strong skin sensitizer. As a result, a section 5(e) Consent Order was negotiated with the Company. This Order prohibits domestic manufacture of the substance and requires that workers at sites controlled by the submitter use protective equipment during processing activities. It also requires that a precautionary label be affixed to all containers of the substance that are distributed, and imposes certain recordkeeping requirements. P83-394 DOMESTIC Chemical Name: Polyglycidyl Amine Concerns were raised for potential carcinogenicity, reproductive effects, liver and kidney effects, and skin and eye irritation if workers are exposed during manufacture and processing. EPA issued a section 5(e) Consent Order requiring protective equipment during manufacture and processing, and labeling. P83-434 DOMESTIC Chemical Name: Unsaturated Aliphatic Diether Concerns were raised for potential carcinogenicity if workers are exposed during manufacture and processing. EPA issued a section 5(e) Consent Order requiring the use of gloves and ventilated laboratory bench hoods during manufacture and processing. -17- ------- SECTION 5(6) CONSENT ORDERS P83-603 DOMESTIC Chemical Name: Substituted Nitrile This section 5(e) Consent Order places restrictions on manufacture and release of the PMN substance pending development of neurotoxicity and aquatic toxicity data. The Company submitted test data for aquatic toxicity and a 28-day neurotoxicity study. A modification of the Consent Order was issued in May extending the production period through November 1984, pending evaluation of submitted data. A further modification has been recommended to permit releases of aqueous waste under specified conditions. [See also Part A.4.] P83-769 DOMESTIC Chemical Name: Disubstituted Heterocycle Protective dust masks were the requirements of the section 5(e) Consent Order which was promulgated to address carcinogenicity concerns if workers are exposed via inhalation during manufacture. The Order went into effect on November 8, 1983. P83-822 DOMESTIC Chemical Name: Trisubstituted Aniline Concerns were raised for potential carcinogenicity to workers who are exposed during manufacture and processing. EPA issued a section 5(e) Consent Order in February 1984 requiring use of impervious gloves during manufacture and special packaging and labeling for processing. The substance is only allowed to be manufactured and processed for one specific use and cannot be distributed outside the Company. -18- ------- SECTION 5(6) CONSENT ORDERS P83-906, 908, 909, 910 DOMESTIC Chemical Name: P83-906 - Brominated Aryl Alkyl Ether P83-908 - Ethylated Amino Phenol P83-909 - Amino Phenol P83-910 - Anilino Ether Potential teratogenicity and carcinogenicity to workers who are exposed during manufacture were the concerns which convinced the Agency to enact a section 5(e) Consent Order for these PMNs. Long sleeved protective gloves were the requirement of the Order, which took effect in November 1983. P83-1023 DOMESTIC Chemical Name: Alkyl Aryl Phosphine A section 5(e) Consent Order was issued in January 1984 which requires the use of air-supplied respirators and protective clothing at both the manufacturing and customer processing sites, pending development of test information to address neurotoxicity concerns. The Company is required to submit neurotoxicity test data before or at the time a specified production volume is reached. P83-1085 IMPORT Chemical Name: Substituted Phenylacetamide A section 5(e) Consent Order requiring full-face shield and long-sleeved protective gloves became effective on December 8, 1983. These restrictions were required in order to reduce worker exposure to possible carcinogens. -19- ------- SECTION 5(6) CONSENT ORDERS 84-27 DOMESTIC Chemical Name: Polyol Carboxylate Ester On April 9, 1984, a section 5(e) Consent Order was signed by the Agency. The Order, brought about by carcinogenicity concerns, places certain restrictions on the manufacturing, processing, distribution in commerce, use and disposal of the substance, including a requirement that, as a condition of distribution the Company must notify, in writing, each person to whom it distributes the PMN substance, of the requirements of the Order. This written notification must also be accompanied by a Material Safety Data Sheet (MSDS). [See Also Part A.4.] 84-105,106,107 DOMESTIC Chemical Name: P84-105 Halogenated Alkene P84-106 Halogenated Alkane P84-107 Halogenated Alkane A section 5(e) Consent Order was signed by the Agency on June 13, 1984 requiring the use of appropriate protective equipment and adequate ventilation in the workplace. Concerns raised were for dermal and inhalation exposure to unprotected workers. The Order took effect June 19, 1984. 84-176, 180 through 184 DOMESTIC Chemical Name: P84-176 Aliphatic Triol Ester Methacrylate P84-180 Polyether Acrylate Ester P84-181 Aliphatic Acrylate Ester P84-182 Polyether Acrylate P84-183 Aliphatic Ester Methacrylate P84-184 Aliphatic Ester Methacrylate The submitter and EPA agreed to the terms of a section 5(e) Consent Order. The Order was signed in May 1984 and addressed carcinogenicity concerns associated with workers if exposed during manufacture, processing and use. The restrictions became effective in June 1984. -20- ------- PART A. FORMAL REGULATORY ACTIONS 4. MODIFICATIONS OF SECTION 5(e) ORDERS -21- ------- SECTION 5(e) ORDERS WITH MODIFICATIONS 83-603 DOMESTIC Chemical Name: Substituted Nitrile Concern for health and environmental effects brought about a section 5(e) Consent Order on this chemical. The Order was modified on May 25, 1984. The modification prohibits manufacture and processing of the PMN substance after November 30, 1984. A further modification addressing treatment and release will be required on or before that date. [See also Part A.3.] 84-27 DOMESTIC Chemical Name: Polyol Carboxylate Ester On April 18, 1984, the Company petitioned EPA for modification of the Material Safety Data Sheet (MSDS) because the specific physical, chemical, and toxicity test results contained in the MSDS may not be applicable to formulated products containing the PMN substance that the Company distributes to its customers. They requested that the language in a portion of the Consent Order be modified to require only that the Company provide its customers with an MSDS which contains, at a minimum, health hazard data and industrial hygiene information which were modified in response to Agency concerns. EPA concluded the change was appropriate and consistent with the purpose of the Consent Order. [See also Part A.3.] -23- ------- PART B. INFORMAL REGULATORY ACTIONS 1. VOLUNTARY TESTING -25- ------- VOLUNTARY TESTING P79-27 DOMESTIC Chemical Name: Alkenyl-Trialkoxysilane The submitter agreed to perform an Ames Test on the PMN substance. The results were obtained after the 90-day notice review period expired and found to be positive. The Company agreed to develop and adopt language for use on warning labels which would alert workers to possible adverse health problems associated with the use of this substance. P79-34 DOMESTIC Chemical Name: Amido-Amine Skin sensitization testing was performed by the submitter to address concerns of exposure to consumers during use. The results mitigated the concerns and the PMN substance was dropped from the review process. P80-238 DOMESTIC Chemical Name: Glycerine, 1-Alkanoate, 3-Substituted Alkanoate This substance went into detailed review because of concern for extreme eye irritation during use. The submitter performed tests showing the chemical would not cause eye irritation as used in the proposed formulation. Based on the submitted test information, the chemical was dropped from review and put into follow-up review for other possible uses. P8 0-267 DOMESTIC Chemical Name: Substituted Phenol, Reaction Products with Sulfur Chloride This substituted phenol was submitted for use as a lubricant additive in later 1980. OTS review of an analog raised concerns for potential skin sensitization. OTS negotiated for and quickly obtained "use level" skin sensitization testing on the PMN substance which revealed that the substance would not present an unreasonable risk. The review period was allowed to expire. -27- ------- VOLUNTARY TESTING P81-58, 59 DOMESTIC Chemical Name: Phenolic Novolak Resin After EPA raised concerns about the chemicals being potential skin sensitizers, the submitter agreed to perform skin sensitization studies. Neither a 5(c) extension nor a 5(e) order were issued, and the submitter provided data within 90 days after the close of the period. The submitter affixed precautionary labeling to containers of the PMN substances during the testing period. Our review of the data indicated no significant concerns regarding sensitization and the labeling was removed. P81-310, 318, 338, 339, 340 DOMESTIC Chemical Name: Modified Phenolic Novolak Resin These chemicals raised concern for skin sensitization. The chemicals were dropped from further review because the submitter agreed to label them as skin sensitizers, indicating the precautions to be taken. The chemicals were placed in follow-up review for other possible uses. Subsequently, the submitter performed tests indicating the chemicals would not cause skin sensitization, and the label requirement was dropped. P81-427 DOMESTIC Chemical Name: Epoxidized Glyceride, Ether with Polyoxyethylene The PMN substance was intended for a use that would involve dermal exposure to the general public. EPA had concern about potential dermal irritation and sensitization effects, and the submitter voluntarily initiated dermal testing. Results of the test were negative, removing the concerns, and the PMN was dropped. P81-500 DOMESTIC Chemical Name: 2-Dodecyl-thiozanthen-9-one A subchronic dermal toxicity test was conducted by the submitter to address EPA's questions concerning discrepancies and observations in the acute tests. EPA had potential concerns for chronic toxicity based on structure activity. The submitter agreed to amend the MSDS to reflect potential concern and to recommend special protection where applicable. -28- ------- VOLUNTARY TESTING P81-532 DOMESTIC Chemical Name: Tetrafunctional Secondary Aromatic Amine The chemical raised concern for skin irritation and histamine release. A possible metabolite caused concern for carcinogenicity, acute autonomic nervous system effects, and liver and kidney toxicity. Exposure was expected to be low and the submitter performed a test that indicated the metabolite will not form; therefore, the case was dropped from further review. P81-558, 660 IMPORT Chemical Name: P81-558 - 4-Hydroxy-3-(5-(2-Hydroxysulfonyloxy) Ethylsulfonyl)-2-Methoxy-Phenylazo)-7-Succinyl Amino-2-Naphthalene Sulfonic Acid Disodium Salt P81-660 - 4-Hydroxy-3-(2-Methoxy-5-Methyl-4-(2- Hydroxysulfonyloxyethylsulfonyl)Phenylazo-l- Naphthalene Sulfonic Acid Disodium Salt Micronucleus testing results were received on the PMN substance and the "drinking water" derivative. The results were reviewed and EPA found that neither substance appeared to induce micronuclei under the conditions of the assays. The Agency decided that this testing adequately addressed concerns for the chemical and thus it was dropped from review. 82-387, 388 DOMESTIC Chemical Name: P82-387 Phosphorodithioic Acid, O,0' Secondary Butyl and Isooctyl Mixed Esters P82-388 Phosphorodithioic Acid, 0,0' Secondary Butyl and Isooctyl Mixed Esters, Zinc Salt The PMNs raised neurotoxicity, reproductive and mutagenicity concerns and the Company submitted reproductive and mutagenic test data. The Agency still had concerns and, following extensive meetings and negotiations, it was recommended that the PMNs be dropped and referred to Existing Chemicals for Section 6 label requirement for motor oils. -29- ------- VOLUNTARY TESTING P82-465 DOMESTIC Chemical Name: Quaternary Ammonium Chloride The submitter provided acute bacterial toxicity testing to address concerns raised for ecotoxicity if bacteria in a publicly owned water treatment plant are exposed via contaminated wastewater. The data indicated that there will be low concern for the use described in the PMN. However, the case was referred for follow-up review because there are several other uses for the chemical that may cause concern, and those data will be useful for follow-up review of other quaternary ammonium compounds. P82-535 DOMESTIC Chemical Name: Modified Phenol Formaldehyde Substituted Alkylamine After the Notice Manager explained Agency concerns that the PMN substance may be toxic to aquatic organisms, the submitter agreed to test the water solubility of the new chemical. The results mitigated the Agency's concerns and the substance dropped from the review process. P82-701 IMPORT Chemical Name: Aromatic Disazo Dye The Agency received short-term mutagenicity data from the submitter to address the concerns for carcinogenicity, and the substance was not found to be mutagenic under the conditions of the test. No further action was recommended on the PMN substance. P83-110 DOMESTIC Chemical Name: Saturated Acid Diester The Company provided Aquatic toxicity testing to address concerns raised for aquatic life which may be exposed to contaminated surface water. After Agency review of the data, it was concluded that the PMN posed no significant risks and dropped the substance from further review. -30- ------- VOLUNTARY TESTING P83-115 DOMESTIC Chemical Name: Naphthalene Disulfonic Acid, Disodium Salt, ((2-((Sodium Sulfoxyethyl)Sulfonyl)Aryl)Azo), and Monochlorotriazinylamino, Substituted, Copper Complex The Agency raised concerns for mutagenic effects to workers who are exposed during processing and use. Test results for an Ames assay were received initially with the PMN submission, but additional data were required in order to properly address the concerns. The PMN was suspended to allow the submitter to perform additional short-term testing. These results indicated no adverse effects. P83-298, 299, 300, 301, DOMESTIC 302, 306, 307, 308, 309, 310 Chemical Name: P83-298, 299 - Toluene Alkylate P83-300, 301 - Dialkyl Benzene P83-302 - Alkyl Benzene P83-306, 307, 308, 309 - Polyalkylbenzene Sulfonate P83-310 - Benzene Alkyl Sulfonate The submitter provided an Ames assay and other test data to address concerns raised for mutagenicity if workers are exposed during manufacture and use. The test results were received and found to be negative. The PMNs were subsequently dropped from review on April 14, 1983. P83-335 IM PO RT Chemical Name: ((Substituted phenyl)azo)naphthalene sulfonic acid, sodium salt The submitter provided an Ames test to address concerns raised for carcinogenicity if workers are exposed during occupational use and if the general public is exposed to contaminated drinking water. The data indicated no adverse effects. EPA has taken no formal regulatory action on this substance. -31- ------- VOLUNTARY TESTING P83-341 IMPORT Chemical Name: 7-[4-[4-chloro-6-[3-2-(hydroxysulfonyloxy) ethylsulfonylanilino]-!,3,5-triazin-2-ylamino] -2-ureidophenylazo]-1,3,6-naphthalene trisulfonic acid, tetrasodium salt Testing to address carcinogenicity concerns were provided by the submitter. The results indicated that no significant hazard to workers or the general public existed during processing and use and the PMN was dropped from review. P83-454 DOMESTIC Chemical Name: Acrylamide Copolymer The submitter agreed to conduct aquatic toxicity testing of this PMN substance. The data indicated a toxicity concern, but the Company submitted further information on exposure which mitigated EPA's concerns. The PMN substance was dropped from further review. P83-479 IMPORT Chemical Name: Monoazo Substituted Aromatic Ames assay test results were received on this chemical following Agency concerns for worker exposure. The review indicated no adverse effects and no further action was taken, P83-486 DOMESTIC Chemical Name: Zirconium Propanoate, Substituted The submitter provided aquatic toxicity testing to address concerns raised for aquatic life forms which may be exposed via contaminated surface water. The data indicated no significant effects. EPA has taken no formal action on this substance. -32- ------- VOLUNTARY TESTING P83-518, 523 DOMESTIC Chemical Name: P83-518 -1,1' [Isopropylidene Bis(6-Hydroxy-M- Phenylene)]Bis(Tetrahydrothiophenium Hydroxide)Bis(Inner Salt) Tetrahydrate P83-523 - 1,1 [Isopropylidene Bis(6-Hydroxy-M- Phenylene]Bis(Tetrahydrothiophenium Hydroxide) Testing was performed by the submitter to determine the chemical impurity level. The concern for the chemical impurity was potential neurotoxicity. The results indicated that the chemical impurity was maintained at safe levels therefore removing Agency concerns. P83-543 DOMESTIC Chemical Name: Polymer of Diethylenetriamine and Higher Polyamine with Dibasic Esters; Reacted with Epichlorohydrin Voluntary aquatic toxicity testing (acute fish and algae and chronic daphnid) was completed in May 1983. Test results were received at EPA on June 7, 1983. The PMN substance was found to be acutely toxic to fish, daphnid and algae; however, based on further analysis it was determined that the PMN substance would not be released in quantities sufficient to create a concern. P83-578 DOMESTIC Chemical Name: Alkoxymethyl polysilazanes The submitter provided eye and skin irritation testing data to address concerns raised for eye and skin irritation if workers are exposed during manufacture, processing, and use. The results indicated no toxicity concern. No further action was taken on this PMN. P83-601 IMPORT Chemical Name: Halogenated Alkene Acid Ester The Company provided acute dermal toxicity testing to address concerns raised for dermal toxicity if workers are exposed during occupational use. The results removed the concerns and the PMN was dropped. -33- ------- VOLUNTARY TESTING P83-680 DOMESTIC Chemical Name: Hydroxyethylaminomethylated Tannin Ecotoxicity testing was performed on this chemical which indicated it was non-toxic to aquatic organisms. It was allowed to be dropped from review. P83-739 DOMESTIC Chemical Name: Diamide of Polybutenyl Succinic Anhydride Eye irritation testing data were provided by the submitter to address concerns raised by the Agency for severe and irreversible damage to the eye if consumers are exposed during use. It was found not to cause any irreversible corneal opacity and the PMN was dropped from review. P83-757, 758, 759 DOMESTIC Chemical Name: Functionalized Acrylic Polymer The submitter agreed to voluntarily conduct aquatic toxicity tests on these PMN substances. The data did not indicate any significant ecotoxicological concern. P83-785 DOMESTIC Chemical Name: Substituted Heteromonocycle Sulfonylphenyl Azo Substituted Naphthalene Sulfonic Acid, Salt The submitter agreed to voluntarily conduct an Ames test using the Prival method. The test results mitigated EPA's concerns for mutagenicity should workers be exposed during manufacture, processing and use. P83-808 DOMESTIC Chemical Name: 2-, 3-, and 4-Pinanol Mixture The submitter provided chemical analysis to identify certain components of the substance to address concerns raised for chronic toxicity if workers are exposed during manufacture and use. The data was evaluated and no significant concerns remained. -34- ------- VOLUNTARY TESTING P83-824 DOMESTIC Chemical Name: Organofunctional Polydimethylsiloxane Eye irritation testing (at low concentrations) was provided by the Company to address concerns for eye irritation to consumers. The data indicated no adverse effects. Previous eye irritation testing (at high concentrations) raised concerns for workers exposed during industrial use. The submitter agreed to amend the Material Safety Data Sheet (MSDS) to reflect this concern. P83-1003 DOMESTIC Chemical Name: Propanoic Acid, 3-[(Dibutoxy Phosphinothioyl) Dithiol] Methyl Ester The PMN review raised concerns of potential delayed neurotoxicity. The submitter conducted two "Neurotoxic Esterase Assays". Each set of results was clearly negative. Based on the results, EPA has no further concern. P83-1026 DOMESTIC Chemical Name: Disubstituted Sulfamoylcarbomonocycle Azo Substituted Naphthalene Sulfonic Acid, Sodium Salt The submitter provided an Ames test using the Prival method to address concerns raised for mutagenicity if workers are exposed during occupational use. The data mitigated the EPA's concerns. P83-1042 DOMESTIC Chemical Name: Acridine, 9-Phenyl Concerns were raised for toxicity to workers exposed during processing. The submitter provided acute toxicity testing which resulted in removing EPA's concerns. -35- ------- VOLUNTARY TESTING P84-73 DOMESTIC Chemical Name: Polyester Polycarboxylate Salt Acute toxicity testing was carried out by the Company to relieve concerns raised for aquatic toxicity. The test results indicated no significant hazard and the PMN was dropped from the review process. 84-259,326 IMPORT Chemical Name: P84-259-Bis(Polyalkylaminetriphenyl)- Bis(Alkylamino) Benzene P84-326-Bis(Polyalkylaminetriphenyl)- Bis(Aminoalkyl)Benzene The Company agreed to voluntary testing to address ecotoxicity concerns. The tests included aquatic toxicity in fish and daphnia and a biological elimination test. The review period for the PMN substance was suspended in order to provide additional time for analysis of data and a final disposition. The exposure estimates indicated that releases to water are below toxicity levels to aquatic species and the PMN substances were dropped. -36- ------- PART B. INFORMAL REGULATORY ACTIONS 2. VOLUNTARY CONTROLS -37- ------- VOLUNTARY CONTROLS P79-12 DOMESTIC Chemical Name: Dodecenyl Succinic Acid, Mono Alkyl Ester The Company agreed to label their container and alter their Material Safety Data Sheet (MSDS) to reflect the eye and skin irritation concerns identified by EPA in the course of its review of the PMN substance. The case was subsequently dropped from further review. P80-182 DOMESTIC Chemical Name: Alkanedioic Acids Mixed Alkanolamines Salt Concerns were raised for carcinogenicity to workers who are exposed during occupational use and to consumers who are exposed during product use. The submitter agreed to address the concern by reformulating the final product. P80-256 DOMESTIC Chemical Name: Methylaziridinyl Carbonylimino Oleyl Trimido Diisophorone Poly(Propylene Glycol) Concerns were raised for carcinogenicity to workers who are exposed during manufacture. In an amendment to the original PMN, at Agency request, the Company stated that the particular feedstock of concern would not be used in the manufacture of the final PMN substance. The Company also agreed to label the containers "Not recommended for spray applications. Inhalation may be hazardous." P81-36 DOMESTIC Generic Chemical Name: Alkyl Acid Phosphorous Esters The PMN substance caused permanent eye damage in test animals. With EPA's assistance, the submitter developed a strongly worded warning label for containers of the new substance. -39- ------- VOLUNTARY CONTOOLS P81-41 IMPORT Chemical Name: 5-Methyl-4H-l ,2 ,4-Triazole-3-Selenol 1,2-Dihydro- 5-Methyl-3H-l,2,4-Triazole-3-Selone This substance for photographic use was the first received under TSCA for use by home hobbyists. EPA's review raised concerns for possible dermal absorption. The substance, packaged in a photographic developing kit, was labeled with a warning to the hobbyist to wear rubber gloves. P81-54 DOMESTIC Chemical Name: Disazo Dye Concerns were raised for dermal toxicity to workers who are exposed during manufacture, processing, and use. The submitter agreed to address the concern by demonstrating that the substance would not be used in such a way that dermal absorption would occur and further agreeing to sell the PMN substance only to customers using proper protective equipment. P81-69, 125 DOMESTIC Chemical Name: P81-69-Salt of Benzophenone Tetracarboxylic Dimethyl ester and Diamines P81-125-Benzophenone Tetracarboxylic Dianhydride Polyimide Carcinogenicity concerns were raised to workers who are exposed during manufacture. The submitter agreed to address the concern by certifying that their enclosed system manufacturing process would be used for all manufacture of the PMN chemicals. Once processed into a final product, exposure to the PMN chemicals was not of concern. -40- ------- VOLUNTARY CONTROLS P81-223 IMPORT Chemical Name: Butanitrile, 3-Hydroxy-2-Methylene The submitter voluntarily agreed to have workers wear protective clothing and glasses because the substance is a skin and eye irritant. The low production volume and these controls mitigated the Agency's concerns and the case was dropped. P81-255 DOMESTIC Chemical Name: Di{2-Propenyl) 3,4,5,6-Tetrabromo-l, 2-Benzene- Dicarboxylate The Agency was concerned that the PMN substance might cause cancer in exposed employees during manufacture, processing and use. The review indicated that exposure would be low due to the use of ventilators and protective gear. The Company also agreed to label the chemical to warn against contact. P81-261 DOMESTIC Chemical Name: Amine Derivative Concerns were raised for irritation, sensitization, and carcinogenicity to workers who are exposed during occupational use and to the general population exposed through contaminated drinking water. The submitter agreed to address the concern by amending the label and Material Safety Data Sheet (MSDS) to advise use of protective clothing, goggles, and respirators for workers and to discourage outdoor use where unprotected persons might be exposed. -41- ------- VOLUNTARY CONTROLS P81-307 DOMESTIC Chemical Name: Alkylphenol Formaldehyde Tackifying Resin Initially this PMN substance was suspected of being a strong sensitizer on the basis of structurally-related chemicals reported to be sensitizers. An isomer of this chemical was under testing for sensitization at the close of the review period. We asked the submitter if he would agree to a voluntary label for potential sensitization should test data for a similar chemical be positive. The Company not only agreed to a voluntary label, but also agreed to amend its draft Material Safety Data Sheet (MSDS) if EPA had reason to believe the chemical was a sensitizer. The test for the structural analog was negative, however, and the Company was informed that labeling was unnecessary. P81-311 DOMESTIC Chemical Name: Maleic Acid, Monoisoocytyamide, Diethane Olamine Salt The PMN substance was to be used to clean machined metal parts. The PMN substance was intended to replace nitrite, but if nitrite were inadvertently added to the cleaning vat with the substance, nitrosamines could form, raising concerns for carcinogenicity. The submitter agreed to add to the Technical Service Data Sheet (TSDS) explicit instructions not to add nitrite to the new substance. P81-317 DOMESTIC Chemical Name: Copolymer of an Unsaturated Amide with Quaternary Ammonium Derivative of an Unsaturated Amide Concerns were raised for ecotoxicity if aquatic life forms are exposed via contaminated surface water. The submitter agreed to address the concern by indicating that the substance is highly toxic to aquatic organisms and that proper usage, as described in the PMN, will result in minimal release of the chemical to the environment. -42- ------- VOLUNTARY CONTROLS P81-445 IMPORT Chemical Name: 4-Trifluoromethoxy Phenylisocyanate Concerns were raised for acute and chronic health effects including carcinogenicity and mutagenicity to workers who are exposed during processing and use. The submitter agreed to address the concern by providing information pertaining to actions that should be taken should the chemical be ingested. The Company also explained the stringent standards for worker safety by using protective equipment and clothing. P81-496 IMPORT Chemical Name: 3-Hydroxy-l-propane Sulfonic Acid The Company agreed to change the Material Safety Data Sheet (MSDS) because the substance was contaminated with a possible carcinogenic impurity. The revised label includes precautionary measures which must be taken when handling the substance and procedures to follow should an accident occur. These controls removed the Agency's concern. P81-531 DOMESTIC Chemical Names: Dialkylated Polyalkene Polyamine A modified warning label instructing users and workers that the substance is harmful if swallowed was added to this PMN. The concerns included skin and eye irritation as well as systemic effects to the kidneys, liver and lungs during exposure. P81-554 DOMESTIC Chemical Name: Metal Alkyl Thiocarbonate Test data were received by EPA for the PMN chemical near the end of the 90-day review period which indicated that the chemical caused severe skin and eye irritation. The Company was asked to revise its Material Safety Data Sheet (MSDS) and label to include notice of these effects and proper precautionary statements. This was accomplished with the resubmission of new labeling before the end of the 90-day period. -43- ------- VOLUNTARY CONTROLS P81-580 DOMESTIC Chemical Name: Poly(Oxy-l,2-Ethanediyl), Alpha-(Carboxymethyl)- Oraega-(4-Nonylphenoxy) During the review of this chemical, serious health effects, including myocardial necrosis, were found for analogues of the chemical in which the average number of a certain repeating unit was between 15-29. The Company agreed not to manufacture its chemical with the number of repeating units in this range. P81-613 DOMESTIC Chemical Name: Alkyl Glucoside Concerns were raised for eye and skin irritation if consumers are exposed during product use. The submitter agreed to address the concern by indicating the irritation potential on the Material Safety Data Sheet (MSDS) and recommending warning label statements. P81-625 DOMESTIC Chemical Name: Blocked Isocyanate The submitter agreed to include a Material Safety Data Sheet (MSDS) recommending ventilation in compliance with Occupational Safety and Health Administration (OSHA) standards as well as protective gear for workers exposed during manufacture and processing. The potential concerns included carcinogenicity and methemoglobinemia if inhaled or ingested. P81-662 DOMESTIC Chemical Name: Substituted Propionamide Test data submitted with the PMN indicated that the chemical would cause blindness. The Company was asked to use a stronger precautionary statement in the Material Safety Data Sheet (MSDS) than "causes severe eye irritation." A newly submitted MSDS carries the precautionary statement, "Corrosive - causes permanent eye injury." -44- ------- VOLUNTARY CONTROLS P81-672 DOMESTIC Chemical Name: Phenyl Acetic Acid Hydrazide The PMN chemical was found to be a potential carcinogen by analogue to other known carcinogens. The Company agreed to place a cancer warning on the Material Safety Data Sheet (MSDS). The Company also submitted more information on the manufacturing process which lowered the concern for worker exposure. P82-12 DOMESTIC Chemical Name: Substituted Polyhydroxy Benzene Derivative The Company agreed to provide a Material Safety Data Sheet (MSDS) and a "process specification booklet" which tells customers, in "cookbook" fashion how to use the chemical. A warning against direct discharge will be placed on the environmental information page of the booklet. P82-44 DOMESTIC Chemical Name: Chloroheteropolycyclic, Hydrochloride Salt The Material Safety Data Sheet (MSDS) was amended by the submitter to reflect EPA's concerns for potential adverse chronic effects for this intermediate. Amendments include an exposure limit and an effects statement. If the exposure limit is adhered to in the workplace, the PMN substance would pose no significant hazard to workers. P82-70 DOMESTIC Chemical Name: 2[(1,3-Dioxolan-2-yl-methoxy)Imino] Benzene Acetonitrile Concerns were raised for acute toxicity to workers who are exposed during occupational use. The submitter voluntarily agreed to include on its product label and Material Safety Sheet (MSDS), a statement prescribing the use of an approved respirator to minimize inhalation exposure. Copies of the label and Material Safety Data Sheet were provided to EPA during the review period. -45- ------- VOLUNTARY CONTROLS P82-72 DOMESTIC Chemical Name: Alkenoic Acid Ester of a Halogenated Alkylaryl Ether Various health concerns were identified for the PMN chemical during review based on analogues. Among them were hepatotoxicity, carcinogenicity, and teratogenicity. The Company was asked to either test its product or revise the label pointing out these effects. The Company submitted unpublished test data on a metabolite of the PMN chemical and revised its label, thus lessening EPA's concerns. P82-129 DOMESTIC Chemical Name: Esterified Copolymer of a Vinyl Compound and an Unsaturated Carboxylic Acid Test data submitted with the PMN indicated that the chemical is a strong skin irritant. The Material Safety Data Sheet (MSDS) only indicated the potential for irritation. After consultation with EPA's toxicologist, the Company agreed to change the MSDS to indicate that irritation will occur on dermal contact. P82-426 DOMESTIC Chemical Name: Substituted Cyclopentadiene The submitter was made aware of the Agency's health concerns (mutagenicity, liver and kidney damage) and offered to label the material sold to its user-customer. The PMN was dropped from review due to low exposure based upon the chemical's low vapor pressure and low dermal absorption. Even so, workers are alerted through the label to avoid all dermal contact with the product and inhalation of its vapors. P83-656 DOMESTIC Chemical Name: Substituted Alkyl Carboxylic Acid, Carbomonocylic Ester Concerns were raised for ecotoxicity if aguatic life forms are exposed via contaminated surface water. The submitter agreed to address the concern by disposing wastes containing the PMN substance in a manner which would not contaminate surface waters. -46- ------- VOLUNTARY CONTROLS P83-683 DOMESTIC Chemical Name: 1-Ethylnyl-l-Cyclopentanol With significant exposure causing sedative effects in workers during manufacture of the PMN substance, the submitter agreed to warn workers of the effects and specify the proper precautions that should appear on the Material Safety Data Sheet (MSDS). With these controls, EPA determined that formal regulatory action against the PMN substance was not necessary. P83-997,998 IMPORT Chemical Name: 83-997 - 6-Diethylamino-2-(Substituted) Spiro(Xanthene-9,3' Phthalide) 83-998 - 6-Dibutylamino-2-(Substituted) Spiro(Xanthene-9,3' Phthalide) Informed of Agency concerns, the PMN submitter agreed to import these substances only in paste form, which would significantly lower worker exposure during use of these substances. Concern was for potential carcinogenicity, especially to workers who use the substances in powder form. P84-150 DOMESTIC Chemical Name: Aminomethylene Phosphonic Acid Following the Agency's request on November 14, 1983, the submitter voluntarily agreed to add a corrosiveness warning to the Material Safety Data Sheet (MSDS). On November 21, 1983, the Agency received the submitter's MSDS with the warning included. -47- ------- Part C. PMNS WITHDRAWN 1. Prior to Likely Section 5(e) Action -49- ------- PMNS WITHDRAWN PRIOR TO LIKELY SECTION 5(e) ACTION P80-2 DOMESTIC Chemical Name: Fatty Acid, Tall Oil, Epoxidized Mixed C7, C9 Alkylester Concerns were raised for potential mutagenicity to workers who are exposed during manufacture and processing and to the general population exposed to contaminated drinking water. This PMN was to have been EPA's first section 5(e) case based solely on significant production volume and substantial exposure and/or release. When the Company learned of Agency intent to require testing through a formal section 5(e) Order, it withdrew the PMN. P80-137, 138, 264 DOMESTIC Chemical Name: P80-137 - Benzamine, 4,4'-Methylene-Bis [N-(l- Methylhexylidene)] P80-138 - Benzamine, 4,4'-Methylene-Bis [N-(l- Methylbutylidene)] P80-264 - Benzenamine, [N-(1-Methylhexylidene)- N1-(l-Methylbutylidene)-4,4'-Methylene-Bis- These PMNs were withdrawn by the submitter on June 21, 1983. They had remained in suspension for over two years while the Company decided whether to conduct testing. The Agency was concerned about hazardous products released during the substance's breakdown. The Company determined that testing would be too costly and withdrew the PMNs. P80-171 DOMESTIC Chemical Name: Polyester of Dicarboxylic Acids Alkylene Diols and Octyl Alcohol 'EPA raised concerns for carcinogenicity and mutagenicity to exposed workers and aquatic toxicity to organisms that are exposed to contaminated surface waters. The submitter withdrew the PMN from the review process immediately prior to issuance of a section 5(e) order. Material belongs to: Office of Toxic Substances Library U.S. L7r.vironmenti;l Protection Agency 40] M'f.;fcet,S.W.TS-793 Washington, D.C. 20460 -51- (202)382-3944 ------- PMNS WITHDRAWN PRIOR TO LIKELY SECTION 5(e) ACTION P81-561, 661 IMPORT Chemical Name: P81-561 - 4-[4-(2-(Hydroxysulfonyloxy) Ethylsulfonyl)-5-Methyl-2-Methoxyphenylazo) -3-Methyl-l-(3-Sulfophenyl-5-Pryazolone P81-661 - 4-Hydroxy-3-(2-Methoxy-5-Methyl-4-(2- Hydroxysulfonyloxy) Ethylsulfonyl) Phenylazo-6- (3-Sulfophenyl)amino-2-naphthalenesulfonic Acid Trisodisum Salt The submitter withdrew the PMNs rather than perform short- term mutagenicity testing as requested by the Agency to address carcinogenicity and mutagenicity concerns. P82-340 IMPORT Chemical Name: Complex Quaternary Ammonium Chloride The Company previously had agreed to negotiate voluntary testing to address some of the environmental effect concerns raised during review of the PMN. The Company later felt that the market potential of the PMN substance did not justify the testing expenditure, and thus withdrew the chemical. P82-401 DOMESTIC Chemical Name: Polyvinyl Starch This PMN, which entered detailed review in July 1982, was withdrawn in September 1982, when the submitter decided against manufacture of the chemical. The concerns initially raised by the Agency were for acute human effects from inhalation. P82-506 DOMESTIC Chemical Name: Alkoxy Ester of N-Methylacetamide Due to carcinogenicity and exposure concerns, this chemical would have, under a section 5(e) Order, required labeling to warn workers that dermal protection would be needed when handling this substance. During development of the Order, the submitter withdrew the PMN, preferring to use resources in the development of a safer product. -52- ------- PMNs WITHDRAWN PRIOR TO LIKELY SECTION 5(e) ACTION P82-586 DOMESTIC Chemical Name: Ethylester of Tertiary Butyl Carbomonocyclic Acid On November 16, 1982, the decision was made to pursue the development of a proposed section 5(e) Order pending the submission of 90-day sub-chronic and possibly 2-year reproduction studies. The submitter withdrew the PMN in December 1982 in face of this development. P83-11 DOMESTIC Chemical Name: Oxirane (Phenyl Methoxy) Methyl This PMN was withdrawn following detailed evaluation of concerns for carcinogenicity, sensitization, and cross- sensitization from exposure in the workplace. The submitter declined to voluntarily provide additional information that EPA considered necessary to address the noted effects. P83-36, 37 DOMESTIC Chemical Name: Acrylated Alkoxylated Aliphatic Glycol Review of this chemical indicated aquatic toxicity problems not alleviated by voluntary testing results. The Agency had additional concerns for carcinogenicity and the PMN was withdrawn. P83-285 DOMESTIC Chemical Name: Phosphate Ester This PMN was withdrawn by the submitter in February 1983 after neurotoxicity concerns to workers developed. The Company declined to voluntarily provide additional information that EPA considered necessary to address the neurotoxicity concerns. -53- ------- PMNs WITHDRAWN PRIOR TO LIKELY SECTION 5(e) ACTION P83-389 IMPORT Chemical Name: ((Substituted Heterocycle)Azo) Substituted Aniline, Acid Salts Concerns were raised for potential teratogenicity to workers who are exposed to the substance during processing and use. The submitter declined to voluntarily provide additional information that EPA considered necessary to eliminate the concern. This PMN was withdrawn in the face of a section 5(e) Order that was under development within the Agency. P83-433 IMPORT Chemical Name: Monoazo Aromatic Compound The submitter withdrew the PMN rather than perform metabolism testing which would have addressed concern for the formation of potential carcinogenic metabolites of the PMN substance. P83-525 IMPORT Chemical Name: Substituted Benzindolium Salt The submitter performed some acute aquatic toxicity testing; however, Agency concerns still existed for acute and chronic aquatic toxicity. In response, the submitter withdrew the PMN in November 1983, rather than perform the additional testing. P83-532 DOMESTIC Chemical Name: Glyceryl Propoxy Diacrylate After the Agency raised concerns for potential skin carcinogenicity to workers who are exposed during manufacture, processing and use, the submitter withdrew the PMN in face of a section 5(e) Order. The Company is, however, continuing its performance of a 2-year bioassay. -54- ------- PMNS WITHDRAWN PRIOR TO LIKELY SECTION 5(e) ACTION P83-606 DOMESTIC Chemical Name: 9,10-Anthracenedione, 2-Methyl-l-Nitro The submitter withdrew the PMN rather than perform dermal absorption testing to determine whether there would be potential significant exposure to the PMN substance, a tested animal carcinogen. P83-673, 674 IMPORT Chemical Name: P83-673 - l-((4-((Substituted Phenyl)Azo) -1-Naphthalenyl) Amino)-3-Methoxy-2-Propanol P83-674 - l-( (4-( ( Substituted PhenyDAzo) -1-Naphthalenyl) Amino)-3-Butoxy-2-Propanol EPA was concerned over possible carcinogenicity if workers are exposed during processing and if the general population is exposed to contaminated drinking water. The submitter withdrew the PMNs rather than perform a 2-year bioassay. P83-676 DOMESTIC Chemical Name: 1-Naphthalene Sulfonic Acid, 6-Amino-5-hydroxy The submitter withdrew the PMN rather than perform an Ames test to address carcinogenicity concerns raised by the Agency. The section 5(e) Order would have banned the substance's manufacture until test data had been submitted. P-83-820, 821 DOMESTIC Chemical Name: P83-820 - Disubstituted heterocyclic azo disubstituted benzene P83-821 - Trisubstituted phenyl azo disubstituted heterocycle Concerns were raised for potential carcinogenicity to workers who are exposed during manufacture and processing and to the general population which may be exposed to contaminated drinking water. The submitter withdrew the PMN to prevent the possible issuance of a formal section 5(e) Order prohibiting manufacture pending the submission of additional information. -55- ------- PMNS WITHDRAWN PRIOR TO LIKELY SECTION 5(e) ACTION 83-845 IMPORT Chemical Name: Tetrasodium Salt of Mu-(2-(2-Hydroxy-3-Nitro-5- Sulfophenylazo)-2'-(2-Hydroxy-5-Substituted-3- Sulfophenylazo)-3,3'-Disulfo-6,6'-Iminodi-l- Naphtholate-(0,0',0'',0''')(S-)Dicopper (II) Acid After EPA expressed concern for carcinogenicity of a potential metabolite of the PMN substance, the submitter made research and development assessments and decided to withdraw the PMN in the face of a section 5(e) Order. P-83-1048 DOMESTIC Chemical Name: Polyether Polyurethane Potential carcinogenicity concerns were raised by the Agency regarding this PMN substance. The submitter declined to voluntarily provide additional information to address the effects of the chemical on workers exposed during manufacture, processing and use. P-83-1057 DOMESTIC Chemical Name: 1,1 Di (Aklylsubstituted)Hydrazine EPA raised carcinogenicity and teratogenicity concerns relating to exposure to workers during manufacture. The submitter preferred to withdraw the chemical rather than enter into a consent agreement for protective equipment. -56- ------- PMNs WITHDRAWN PRIOR TO LIKELY SECTION 5(e) ACTION P-83-1267, 1268, 1270 IMPORT Chemical Name: 83-1267: 9H-Thioxanthen-9-one, 2,4-Diethyl 83-1268: 9H-Thioxanthen-9-one, 2,4-Dimethyl 83-1270: 9H-Thioxanthen-9-one, 4-chloro- Concerns were raised for potential hepatotoxicity if workers are exposed during processing. The submitter withdrew the PMN to prevent issuance of a section 5(e) Order prohibiting importation pending the submission of additional information. P83-1281, 1283, 1284, 1286, 1287, 1288 IMPORT Chemical Name: P83-1281 - Premetallized Aromatic Substituted Disazo P83-1283 - Substituted Aromatic Disazo P83-1286 - Aromatic Substituted Triazo P83-1284, 1287, 1288 - Reaction Product of Diazotized Aromatic Compounds with Fustic Extract The submitter has voluntarily withdrawn these PMNs in the face of a section 5(e) Order requiring a 2-year bioassay on each PMN substance. When the decision was made to require bioassay and ecotox testing to address carcinogenicity and ecotox concerns, the submitter withdrew the PMN due to the expense of the tests. P-84-66 IMPORT Chemical Name: Substituted Phenol-Formaldehyde Condensate Possible releases of the PMN chemical into surface waters, which exhibited potential aquatic toxicity, were a significant concern of EPA's. The Company needed further information to mitigate these concerns, but instead it decided to withdraw the PMN from review. -57- ------- PMNs WITHDRAWN PRIOR TO LIKELY SECTION 5(e) ACTION P-84-69 IMPORT Chemical Name: Substituted Anthraquinone Ammonium Salt Concerns were raised for potential aquatic toxicity to aquatic organisms exposed to releases from processing. The submitter withdrew the PMN to prevent the possible issuance of a section 5(e) Order prohibiting importation pending the submission of additional information. P-84-86 IMPORT Chemical Name: Heterocyclic Azo Substituted Aromaric Compound The Agency expressed concerns for potential aquatic toxicity if aquatic organisms are exposed to releases from processing, and for carcinogenicity if workers are exposed to releases from processing, and the general population if exposed to contaminated drinking water. The submitter withdrew the PMN rather than perform the testing. 84-93 DOMESTIC Chemical Name: Substituted-lH-Isoindol-1-One On June 12, 1984, the submitter withdrew the PMN in the face of a section 5(e) Order, after a series of suspension periods intended for further research and development on the PMN substance. P-84-161 DOMESTIC Chemical Name: Reaction Product of Urea, Diethylene triamine, Cardura E and Allyl Glycidyl Ether Rather than enter into a consent agreement, the Company withdrew the chemical after the EPA had shown concerns for potential carcinogenicity to workers who are exposed to the PMN substance. -58- ------- PMNs WITHDRAWN PRIOR TO LIKELY SECTION 5(e) ACTION P-84-253 DOMESTIC Chemical Name: Blocked isocyanate modified epoxy resin The submitter withdrew this PMN in the face of a possible section 5(e) Order which would have prohibited manufacture of the substance pending further testing. The concern was for worker exposure to a potential carcinogen during manufacture, processing and use. Additional data was necessary to make an accurate finding. 84-262 DOMESTIC Chemical Name: Safflower Oil; 1,2 ,3-Propanetriol; 2,5- Furandione; 4,5,6,7,88-Hexachloro-3A,4,7,7A- Tetrahydro-4,7-Methanoisobenzofuran The levels of a potentially carcinogenic impurity in the PMN substance was the source of concern which called for a 2-year bioassay. The PMN was withdrawn in the face of a section 5(e) Order, with no further test results submitted. 84-304 DOMESTIC Chemical Name: Benzyl Dialkyl Methyl Quaternary Ammonium Chloride The submitter decided to withdraw the PMN from the review process in face of a section 5(e) Order which would have required controls pending the submission of information on aquatic toxicity. The submitter felt that the expense of the tests was prohibitive. 84-305 DOMESTIC Chemical Name: 2-Propenoic Acid, 2-Methyl-, 2- (((((1,Methylpropylidene)Amino)Oxy)Carbonyl) Amino)Ethyl Ester Following concerns for carcinogenicity, a 5(e) Consent Order was proposed by the Agency. The section 5(e) Consent Order, followed by a Significant New Use Rule ( SNUR) , would require air supplied respirators as well as gloves. The Company withdrew the PMN in the face of the Order. -59- ------- PMNS WITHDRAWN PRIOR TO LIKELY SECTION 5(e) ACTION 84-531 IMPORT Chemical Name: Cyanoethylated Isophoronediamine The Agency expressed concerns for teratogenicity and neurotoxicity. An Ames assay was performed and the results were found to be negative. The teratogenic concerns still exist. The submitter withdrew the PMN in the face of a section 5(e) Unilateral Order which would have required oral teratology testing. -60- ------- Part C. PNNs WITHDRAWN 2. Prior to Likely Section 5(£) Action -61- ------- PMNS WITHDRAWN PRIOR TO LIKELY SECTION 5(f) ACTION P82-251 DOMESTIC Chemical Name: 3,4-Dichlorophenol The Agency was developing its first proposed section 5(f) Rule for this PMN (concerns identified were oncogenicity, eye corrosivity, chloracne, fetotoxicity, reproductive effects and ecotoxicity). A section 5(c) notice extending the review period was signed on June 25, 1982. The submitter withdrew the PMN from the review process on the same day, stating that it did not wish to be the subject of EPA's first TSCA section 5(f) Order. P83-350 DOMESTIC Chemical Name: 2-Propoxyethyl Acetate Ihis PMN was withdrawn because of a potential section 5(f) Rule pending related Section 6 action on glycol ethers. The concerns were raised for teratogenicity to workers who are exposed during handling, and consumers during product use. P83-654 DOMESTIC Chemical Name: Lauryl Sulfate Salt with 2-Amino-2-Methyl-l- Propanol The submitter voluntarily performed eye irritation testing on concentrations of the PMN substance used in consumer products. At such levels, the substance was found still to cause irreversible corneal opacity. Ihe submitter was given the option of testing the compound at even lower concentrations. If it were found to cause "no effects," EPA would then consider proposing a section 5(f) Rule that would prohibit use at higher concentrations. Ihe submitter decided to withdraw the PMN at this time and perform further testing on the chemical. -63- ------- Tables of PMN Activities -65- ------- Table 1. Annual Compilation of PMN Program Actions Through June 30, 1984 Valid PMN's Received 5 (e) Orders Issued Consent 5{e) Orders Issued 5 ( f ) Rules Issued Informal Action - Voluntary Testing Informal Action Voluntary Controls PMNs Withdrawn In Face of Likely 5(e) order PMNs Withdrawn In Face Of Likely 5 (f) Order Total FY'79 8 0 0 0 0 0 0 0 0 FY'80 281 2 (7 PMNs) 0 0 1 1 1 0 5 FY'81 580 0 0 0 10 13 1 0 24 FY'82 839 1 (2 PMNs) 1 (2 PMNs) 0 5 16 1 1 25 FY'83 1301 2 (4 PMNs) 8 (117 PMNs) 0 42 2 18 2 76 FY'84* 870 1 (1 PMN) 9 (19 PMNs) 2 (3 PMNs) 14 4 27 0 57 Total 3,880 6 (14 PMNs) 18 (138 PMNs) 2 (3 PMNs) 72 36 48 3 185 I o\ -J I * As of June 30, 1984 ------- Table 2: Percentage of Commencement of Manufacture Notices Received Valid FY 79 FY 80 FY 81 FY 82 FY 83 FY 84 PMNs Received 8 281 580 839 1301 870 % of Notice of Commencements Received Number 6 165 359 471 503 125 % 66.7% 58.7% 61.9% 56.1% 38.6% 14.4% -68- ------- Table 3. Annual Compilation of PMN Activities by Specific Concern FY 1980 Action Type Toxlclty Concern Carcl nogen 1 c 1 ty/Mutagen Ic 1 ty Teratogen 1 c 1 ty /Fetotox 1 c 1 ty Reproductive Effects Acute Effects Other Chronic Toxlclty Ecotoxlclty Exposed Populations Workers Consumers Environment Voluntary Testing Domestic 1 0 0 0 0 1 0 0 Import 0 0 0 0 0 0 0 0 Vo 1 untary Controls Domestic 0 0 2 0 0 1 0 0 Import 0 3 0 0 0 0 0 0 55 (e) Order Domestic 6 0 1 0 6 7 1 6 Import 0 0 0 0 0 0 0 0 Withdrawn In the face of a 55 (e) Order Domestic 9 0 1 1 0 5 2 0 Import 0 0 0 0 0 0 0 0 -69- ------- Table 4. Annual Compilation of PMN Activities by Specific Concern FY 1981 Action Type Toxlclty Concern Care 1 nogen 1 c 1 ty/Mu tagen 1 c 1 ty Teratogen 1 c 1 ty/Fetotox I c 1 ty Reproductive Effects Neurotoxlclty Acute Effects Ecotoxlclty Exposed Populations Workers Consumers Env 1 ronment General Population Voluntary Test 1 ng Domestic 0 0 10 0 8 2 0 0 Import 0 0 0 0 0 0 0 0 \foluntary Controls Domestic 6 1 7 1 8 1 1 1 Import 0 0 2 1 2 1 0 0 55 (e) Order Domestic 0 0 0 0 0 0 0 0 Import 2 0 0 0 2 0 0 2 Withdrawn In the face of a $5(e) Order Domestic 0 0 0 0 0 0 0 0 Import 0 0 0 0 0 0 0 0 -70- ------- Table 5. Annual Compilation of PMN Activities by Specific Concern FY 1982 Action Type Toxic tty Concern Carcinogenic I ty/Mutagenlclty Ter atogen 1 c 1 ty /Fetotox 1 c 1 ty Reproductive Effects LIverAldney Neurotoxlclty Acute Effects Other Chronic Toxic Ity Ecotoxlclty Exposure Concerns Worker Consumer Environment General Population Vo 1 untary Test 1 ng Domestic 1 0 2 1 4 0 1 2 0 1 1 Import 0 0 0 0 0 0 0 0 6 0 0 Voluntary Contro 1 s Domestic 6 0 5 0 9 3 1 11 3 1 0 Import 3 0 0 0 2 0 0 2 0 0 0 $5(e) Order Domestic 0 0 0 0 4 0 0 0 2 0 0 Import 0 0 0 0 0 0 0 0 0 0 0 Withdrawn In the face of a J5(e) Order Domestic 2 2 0 0 2 1 0 2 1 1 1 Import 2 0 0 0 0 0 0 2 2 1 2 -7 1 - ------- Table 6. Annual Compilation of PMN Activities by Specific Concern FY 1983 Action Type Toxlclty Concern Care 1 nogen 1 c 1 ty/Mutagen 1 c 1 ty Teratogen 1 c 1 ty /Fetotox 1 c 1 ty Reproductive Effects Liver/Kidney Neurotoxlclty Acute Effects Ecotox 1 c 1 ty Exposure Populations Worker Consumer Environmental General Population Voluntary Testing Domestic 14 0 1 2 3 8 18 1 8 2 Import 5 0 0 0 1 0 5 0 0 1 Voluntary Controls Domestic 0 0 0 0 2 0 1 0 1 0 Import 0 0 0 0 0 0 0 0 0 0 55 (e) Order Domest 1 c 8 1 12 1 2 2 8 0 2 0 Import 2 1 0 0 0 0 3 0 0 2 Withdrawn In the face of a §5(e) Order Domestic 7 2 2 1 1 2 12 2 2 2 Import 5 3 0 0 0 1 7 0 1 0 -72- ------- Table 7. Annual Compilation of PMN Activities by Specific Concern FY 1984 Action Type Toxic Ity Concern Care 1 nogen 1 c 1 ty/Mutagen Ic 1 ty Ter atogen 1 c 1 ty /Fetotox 1 c 1 ty Reproductive Effects Liver /Kidney Neurotoxlclty Acute Effects Other Chronic Toxic Ity Ecotoxlclty Exposure Populations Worker Consumer Environment General Population Voluntary Testing Domestic 2 2 0 3 1 0 0 3 2 0 0 Import 3 0 0 0 0 0 2 3 0 2 1 Voluntary Controls Domestic 0 0 0 0 1 0 0 1 0 0 0 Import 2 0 0 0 0 0 0 2 0 0 0 $5(e) Order Domestic 16 7 3 0 1 3 0 20 0 0 0 Import 2 0 0 0 0 0 0 2 0 0 0 Withdrawn In the face of a 55(e) Order Domestic 2 1 0 0 0 0 0 3 0 0 0 Import 11 1 0 1 0 0 5 7 1 5 1 -73- ------- Table 8. Historical Compilation of Specific Concerns Underlying Formal and Informal Regulatory Action Domestic U.S. Import Chemicals Toxic Ity Concern Care i nogen 1 c 1 ty/Mutagen Ic i ty Ter atogen 1 c 1 ty /Fetotox 1 c 1 ty Reproductive Effects Liver/Kidney Neurotoxlclty Acute Effects Other Chronic Toxic Ity Ecotoxlclty Exposure Populations Worker Consumer Environment General Population FY« 80 Domestic 16 3 0 0 4 1 6 14 3 6 0 Import 0 0 0 0 0 0 0 0 0 0 0 FY« 81 Domestic 6 0 0 1 17 0 1 16 3 1 1 Import 2 0 0 0 2 0 1 4 1 0 2 FY' 82 Domestic 9 2 7 1 19 4 2 15 6 3 2 Import 5 0 0 0 2 0 0 4 2 1 2 FY'83 Domestic 29 3 15 4 8 0 12 39 3 13 4 Import 12 4 0 0 1 0 1 15 0 1 3 FY»84 Domestic 20 10 3 3 3 3 0 27 2 0 0 Import 18 1 0 1 0 0 7 14 1 7 2 Totals Domestic 80 18 25 9 51 5 21 111 17 23 7 Import 37 5 0 1 5 3 9 37 4 9 9 Through 6/30/84 ------- Rate of Growth for Valid PMNs Received by EPA since Program Inception 1400 1200 - 1000 800 600 400 200 1979 1980 1981 1982 (FY PMNs Received) 1983 1984* * (Fiscal Year Projection) Domestic/Import PMNs 1400 1200 1000 800 600 400 200 Valid PMNs D 1979 1980 1981 1982 1983 *1984 8 8 0 281 273 8 580 502 78 839 701 138 1301 1071 230 1220 976 244 - Valid PMNs - Domestic - Import FY79 FY80 FY81 FY82 (PMNs by Fiscal Year) TirU.8. GOVERNMENT PRINTING OFFICE: 198«t i»5i» 513 19380 FY83 FY84* * (Fiscal Year Projection) ------- |