1! 9,3 CONGRESSIONAL RESEARCH SERVICE LIBRARY OF CONGRESS umuii niver i O 1 nm 0 M iii: 8 3 609 UN IufI;iri1Iiiiiu‘iIrrntua TOXIC SUBSTANCES CONTROL ACT: TESTING ISSUES ISSUE BRIEF NUMBER IB78050 AUTHORD ncnally, Jo-Ann Science Policy Research Division Carr, Geraldine Science Policy Research Division THE LIBRARY OF CONGRESS CONGRESSIONAL RESEARCH SERVICE HAJOR ISSUES SYSTEM DATE ORIGINATED Qgggggzg DATE UPDATED Qggggggg bFOR"ADDITIONAL'INFORHATION CALL 287-5700 0116 c3s- 1 IB7805O UPDATE-O1/16/80 .5.'§.Q§_.12§§l§. EELQ1.‘ 4 The Toxic Substances Control Act (TSCA, P.L. 94-469) authorizes the EPA to zregulate commercial chemicals which the EPA can prove present an unreasonable risk of injury to health and the environment. Because the EPA bears the "regulatory burden of proof during the rulemaking procedures, it is important that the EPA has adequate data. For this reason, the implementation of those sections of TSCA which authorize the EPA to require industry to conduct tests and submit the results to the EPA could be critical to the effectiveness of the Act. TSCA's testing authorities could also produce information which would be important for regulation under other legislation. The following issues which will probably affect the implementation of these testing sections are examined in this issue brief: availability of testing resources, testing priorities, interagency coordination, generation and interpretation of test data, quality assurance of test data, and effects on industry. nu: nt- 0 9: G) Ito O c: 2 U luv |= It! I. I0 It-' IH In M The EPA can, by rule, require manufacturers and processors of chemicals to conduct and pay for tests on their products if the EPA can demonstrate that such chemicals: (1) may present an unreasonable risk of injury to health or the environment, or there may be substantial human or environmental exposure; 3) there are insufficient data and experience for determining or predicting the health and environmental effects; and (3) testing is necessary to develop such data. On the basis of data from such tests and other information, the EPA may regulate the manufacturing, processing, distribution in commerce, use, and disposal of hazardous chemicals. The EPA is responsible for prescribing the standards that manufacturers and processors must follow in their development of the required test data under section a of TSCA. Test standards may be prescribed with regard to any effect on health or the environment which may prove an unreasonable risk including, but not limited to, the following: carcinogenic, mutagenic, and teratogenic effects; behavioral disorders; cumulative or synergistic effects; persistence; and acute, subacute, and chronic toxicity. The methodologies which may be prescribed in such standards include epidemiological studies, serial or hierarchial tests, ig_y;tgg (“test tube“) tests, and whole animal tests. when prescribing the standards, the EPA is directed to consider the wrelative cost of the various test protocols and methodologies and the reasonably foreseeable availability of the facilities and personnel necessary to perform the testing required under the rule. The EPA is required to review the adequacy of the standards at least once a year and make revisions as necessary. A An 8-member Federal Interagency Testing Committee Twas established under section a(e) of TSCA to provide the EPA with a list of up to 50 chemical substances (or groups of substances) and mixtures‘ which the Acommittee -,lieves are priority candidates for health and environmental safety testing. At least once every 6 months, the Committee is required to make any necessary revisions in the list. The Committee submitted its initial priority; list,wx which included 4 chemicals and 6 groups of chemicals, on Oct. 4, 1977. The Committee submitted its first update, which added 4 chemicals and A groups of CRS- 2 IB7805O UPDATE‘OI/16/80 chemicals to the priority list, on Apr. 10, 1978, and its second update, which added one chemical and two groups of chemicals to the priority list in October 1978. Once the EPA has received the initial list and each update, the EPA has one year to either initiate testing requirements for th chemicals included or to publish their reasons for not initiating such testing requirements. The EPA has responded to the Committee's initial priority list by publishing in the Oct. 26, 1978 Federal Register its reasons for not yet being able to require testing although the EPA considered this recommendations to be valid. Under Section u(f) of TSCA, after Jan. 1, 1979, upon the receipt of any test or other data which indicates to the EPA that there may be a reasonable basis to conclude that a chemical presents or will present a significant risk of serious or extensive harm to humans from cancer, gene mutations, or birth defects, the EPA has 180 days (with a possible 90-day extension) to. initiate appropriate action under the regulatory sections of TSCA to prevent or reduce such risk to a sufficient extent or to publish reasons why such risks are no unreasonable. ~ Premanufacturing and preprocessing notices for chemical substances which are new or are used for a significant new use are required under section 5 of PTSCA to include any test data in the possession or control of the person giving such notice which are related to the effect of any manufacturing, processing, distribution in commerce, use, or disposal of such substance or any article containing such substance on health and the environment. Although section 5 of TSCA does not authorize the EPA to require, the development of new information on health and environmental effects by ~premanufacture testing of new chemical substances, the EPA can take action to prohibit or limit the manufacture, distribution in commerce, use, or disposa of a new chemical substance pending development of additional information on its health or environmental effects under the following circumstances: (1) the information available to. the EPA during the premanufacture notification period is insufficient to permit a reasoned evaluation of the health and environmental effects of a new chemical substance and (2) the EPA finds that the substance may present an unreasonable risk of injury to health or the environment or‘ that it will be produced in substantial quantities and result in isubstantial human exposure or environmental release. Any manufacturer or processor who is required to submit a premanufacturing or processing notice may petition the EPA to prescribe standards for the development of test data for such substance .even if there is no requirement for such testing. Under section 10 of TSCA, the EPA is directed to coordinate with the Department of Health, Education, and Welfare (DHEW) any research directed toward the following: the development of rapid, reliable, and economical screening techniques for carcinogenic, mutagenic, teratogenic, and ecological 9 effects ,of chemicals; the development of monitoring techniques and instruments which may be used in the detection of toxic chemicals which are reliable, economical, and capable of being implemented under a wide variety of conditions; and the establishment of research programs to develop the ‘fundamental scientific basis of screening and monitoring techniques, the bounds of reliability of such techniques, and the‘ opportunities for the. ,improvement. Under section 27 of TSCA, after consultation with the EPA, the ADHEW may‘ also conduct projects for the‘ development. and evaluation of, inexpensive and efficient methods for the determination and evaluation of the health and environmental effects of chemicals along with. their toxicity, cas- 3 IB'7805O UPDATE-O1/16/80 persistance, and other characteristics which effect health and the environment. DREW may also conduct projects which may be used for the development of test data to meet the requirements of the test standards. vezailabilirz 2.t..Ie§.2.:L;1.9. Re§22.r.-e§ Resources necessary for the testing lof chemicals for health and 'environmental effects include: trained specialists such as toxicologists, »epidemiologists, botanists, and veterinary pathologists; specially bred and raised laboratory animals; expensive laboratory facilities; test microcosms; and a wide variety of wildlife species. Because the state-of-the-art for ecological effects testing is not yet very advanced, so little is actually known about some areas that it may be impossible to even predict what an adequate supply of test species and facilities would be. Resources for health effects testing are already in high demand for testing substances under other laws (such as the Food, Drug, and Cosmetic Act). Because 'TSCA requires that the availability of testing personnel and facilities be considered when the ‘EPA decides to require testing for chemicals, the availability of testing resources could become the limiting factor for the amount of chemical testing required under TSCA. Trained specialists will be needed by both industry and the EPA for the following: to conduct the tests required by TSCA; to help establish the “‘EPA's test standards; to evaluate the test data which is submitted to the EPA; and to conduct the basic research which will lead to the development of better test methods. It is generally estimated that about 1,000 additional toxicologists alone will be needed within the next few years and that about /0 more toxicologists will be required each subsequent year to meet the. testing that could reasonably be required under TSCA. Although the National Institute for Environmental Health Sciences and various chemical companies have begun programs to support the basic training of toxicologists to fill this anticipated need, some doubt that this effort will be sufficient. Although the availability of laboratory animals and facilities is not generally thought to be as critical as the availability of trained specialists (except for some ecological effects testing), these resources will also be strained by the testing requirements ofp TSCA. For the short term, testing resources can possibly be reprogrammed with only slight damage to other disciplines. However, plans should be considered now to provide additional testing resources to meet the projected long-term needs of TSCA in order to prevent future delays and inadequacies. ?.e§.r;29-.1?.r.i.2r;1..ti.<-2§ Because it would be impossible for the EPA to require the testing iof all chemicals to determine if they present an; unreasonable irisk of injury to ‘health and the; environment, the; EPA mustt establish testing priorities- Hazardous chemicals night not be a testing priority if sufficient test data ,already existed for their regulation. They real; problem ist establishing ‘priorities for. testingh the estimated 70,000 untested chemicals now in commerce in order to find, test, and, if necessary, regulate those ~chemicals x.at present the greatest hazard. TSCA directs the Interagency Testing Committee to consider the following factors each time it revises its list of priority, chemicals for testing: quantities which are or will be manufactured; quantities which; are or will C33. 4 T IB‘7805O UPDATE-O1/16/80 enter the environment; the number of individuals who are or will be exposed in their places of employment and the duration of such exposure; the extent to which humans are or will be exposed; the extent to which the substance or mixture is closely related to another which is known to present a: unreasonable risk of injury to health or the environment; the extent to which testing may result in the development of data upon which the effects of the -substance on health or the environment can be reasonably determined or predicted; and the reasonably foreseeable availability of facilities and personnel for performing testing on the substance or mixture. The problems the Interagency Testing Committee encountered in compiling their priorities list will probably be representative of the type of problems which will confront the EPA when it tries to designate additional chemicals as priorities for testing. Problems noted by the Committee in establishing their priorities include: the lack of a readily available and consolidated data base on chemical substances and mixtures; difficulties in obtaining production, use, and exposure data; and difficulties in defining groups of chemical substances and mixtures (which the Committee is allowed to do under TSCA) in such a way that the groups would not be too broad and cumbersome to test and yet would be large enough to include related, suspicious chemical. substances and mixtures. some of the data deficiencies will probably be resolved once information gathered through the inventory (a listing of all chemicals now in commerce along with use, volume, production location, and other information) and other reporting under TSCA is completed. lutsre9sn9z-£92rQi2eti2n In addition to the EPA (which is also responsible for implementing air l pesticide, waste disposal, and water legislation), the following agencies either develop test data to support regulatory actions or use test results to regulate hazardous chemicals: the Occupational Safety and Health Administration (OSHA); the Food and Drug Administration (FDA); the Consumer Product Safety Commission (CPSC); the National Institute for Occupational Safety and Health (NIOSH); the National Center for Toxicological Research (NCTB); the National Institute for Environmental Health Sciences (NIEHS); the National Cancer Institute‘ (NCI); the Department of Defense (DOD); the National Toxicology Program; and the Department of Energy (DOE). The extent to which interagency coordination may result from the implementation of the testing provisions of TSCA may’ ultimately depend upon the relationship between the authorizing legislation of each agency. TSCA's jurisdiction includes all commercial chemical substances and mixtures with the exception of the following: pesticides, tobacco, nuclear material, firearms, ammunition, food, food additives, drugs, and cosmetics. TSCA also stipulates ” that its authorities can only be used if other legislative authorities are not more appropriate. °TSCA' has Astrong .testing and" information-gathering authorities but, since TSCA is not a registration Act (where industry »must prove that its products are safe before a regulatory agency will approve them for marketing), the EPA must bear the burden of proof when it wants to regulate or require testing for a suspect chemical. ’ other agencies may find use for the EPA's unique authority under TSCA to require testing for a broad range of chemicals which have not been submitted P for some type of registration. For example, it is possible that if both t. CPSC and the EPA felt that a certain substance presented an unreasonable risk of injury to health and the environment and that the CPSC wanted to regulate such a substance under one of its acts (which have been interpreted by the CPSC to have little or no testing authority) but did not have quite enough cRs- 5 1373050 ‘UPDATE-01/16/80 test data to prove that the substance was hazardous, the EPA could use its TSCA authority to require industry to provide the CPSC with the necessary, test data. Interagency coordination directed toward the standardization of test ~methods and sharing of test data may be necessary to make the most efficient ruse of TSCA's testing authority. The 4 health and safety regulatory agencies (EPA, FDA, OSHA, and CPSC) are currently working through their recently ‘established Interagency Regulatory Liaison Group to standardize their test methods, share test data, and generally increase cooperation and coordination. Total standardization of test methods may be difficult due to differences between each agency's statutory authorities and responsibilities. For example, in order for the FDA to ban a food additive under the Delaney Clause of the Food, Drug, and Cosmetic Act, the FDA only needs test results which prove that a food additive is carcinogenic, but other agencies not mandated to completely ban carcinogens under their legislation, might wish to have results from tests which yield dose/response information in order to establish the most appropriate level of exposure (which may not be zero due to the benefits of the chemical). In any case, it certainly would make the most effective use of limited testing resources if the smallest possible number of tests could be conducted on any one compound to satisfy the needs of all the regulatory agencies. The most precise way to determine a chemical's toxicity would be to test it directly on man and the environment. » However, not only would such testing frequently run contrary to one of the main purposes of TSCA - predicting the potential hazard of chemicals before extensive exposure -- but it would also be unethical to test in humans and impossible to monitor in the environment.‘ Because of this conflict, laboratory tests must be used to determine a chemical's toxicity. Due to the limit of available testing resources, not all laboratory tests can be run on each chemical. The EPA published a pre-proposal titled “Guidance for Premanufacture Testing: Discussion of Policy Issues, Alternate Approaches, and Test Methods“ in the Mar. 16, 1979 Federal Register [#4 FR 162flO-92]. This pre-proposal aired several approaches that the EPA was considering toward guidance for premarket testing and asked for comments from interested parties. The EPA plans to propose guidance for premanufacture testing after it has resolved a number of complicated policy issues. Any testing system which the EPA decides to use under TSCA must be flexible enoughv tow change with the state-of-the-art. Acute mammalian toxicity tests are fairly well, established, as .are acute environmental toxicity tests for some species. The state-of-the-art for chronic toxicity tests (such as neuro-toxicity and carcinogenicity) is much less advanced, and some other ecological effects tests have fhardly been explored at all. Because tests are currently being developed to fill this need, the state-of-the-art for toxicity testing is far from stable. TSCA directs the EPA and the DHEH, to conduct research‘ directed toward developing and evaluating such toxicity test methods (see the section titled “Outline of ‘ ; CA's Testing Provisions"). Because of a lack of agreement among scientists concerning ythe interpretation of test data, the EPA will rarely be able to rest on solid scientific ground when it determines the toxicity of a chemical. Scientists CRS- 6 y 1373050 UPDATE~01/16/80 are currently disagreeing over the following questions: whether data from animal tests can be extrapolated to man (because of the shorter lifetime and (different metabolism of most test animals), whether the administration of high doses of test substances in animals causes the same reactions as woul low doses in man (because high doses may override repair or detoxification mechanisms), whether ;g_g;tg9 tests can be used to predict carcinogenicity and mutagenicity, and whether a structural relationship between chemicals can be used to predict toxic characteristics. Because the state—of-the-art for interpreting test data is not yet at a point where 100% accurate decisions can be made concerning the toxicity of a substance, the EPA will often have to decide whether to err on the side of caution or on the side of minimal economic injury. This means that the EPA will basically be making a policy decision: (1) each time it determines that a chemical is toxic and (2) each time it decides if the hazard presents unreasonable enough risk to require regulation. ~ The EPA is considering including provisions for quality assurance— in its: test standards under TSCA. Inaccurate or fraudulent test data could mislead the EPA and other regulatory agencies to allow the marketing of chemicals which present “an unreasonable risk to man and the environment.“ Although it would probably occur less frequently, inaccurate. test data could also unfairly condemn safe chemicals as being hazardous.: Because both situations work to reduce safety and _competitive equality, some controls over the quality of test data are desirable. A recent FDA inspection of 100 testing laboratories operated by manufacturers, universities, and independents has been reported to have uncovered extensive shortcomings in record—keeping an animal handling. one recent example of such shortcomings is the serious testing deficiencies which allegedly occurred at Industrial Bio-Test Laboratories (IBT). The EPA and the FDA are both currently investigating the problem and have requested that companies who used IBT data to justify safety requirements for the registration of products under either the Food, Drug, and Cosmetic Act or the Federal Insecticide, Pungicide, and Bodenticide Act reexamine all of their test data. If, upon reexamination, the test data are not sufficient to support a determination of safety for a product, its registration could be cancelled or suspended until additional tests are run. some type of a qualityaassurance program could prevent the type of delays, additional expenses, and confusion which has already sheen caused by the alleged IBT testing deficiencies. Such a program could include good_ laboratory practices similar to those proposed by ithe FDA, laboratory and personnelm licensing, inspections, and personnel training requirements. Whether or not the additional expenses and delays that might be caused by such a quality-assurance program for test data would be ~justified by any increases in accuracy and reliability of test data is still open to question- Effeste on Lnduetrz TSCA provides the E?A with the potential for a great deal of control mover industry from the moment the latter decides to market a product to the time of that product‘s disposal. ‘Industry appears to be generally concerned wifhq the following aspects of TsCA's testing provisions: the amount of testihy that will be required, the cost effects of such testing, the- confidentiality of test—related data, and general uncertainty over the specific requirements of the testing provisions of TSCA. Congress has directed the EPA to consider industry's problems while implementing TSCA by stating in the Act, "It is the cBs- 7 1373050 UPDATE—01/16/80 intent of Congress that the [EPA] shall carry out this Act in a reasonable and prudent manner, and that the [EPA] shall consider the environmental, economic, and social impact of any action the [EPA] takes or proposes to take Jder this Act." The language of TSCA provides the EPA with a great deal of flexibility .concerning the amount of testing which the EPA can require industry to conduct. The EPA needs only to prove that tan unreasonable risk may be ‘presented by a chemical (such as little or no information on effects but ~substantial human or environmental exposure) before it can require testing. Not only can testing be required for individual chemical substances, but testing may also be required for mixtures, groups of chemicals or mixtures, or perhaps even products containing certain chemical substances and mixtures. Because even the most inexpensive toxicology tests cost about $1,000 per compound and a full battery of tests for any one compound could cost about $500,000 and take 2 to 3 years, industry is concerned over the amount of testing which the EPA will require under TSCA. For example, one estimate suggests that it might cost $2 billion to test all known chemicals currently in the environment and that it might cost another $300 million a year to test new chemicals. «Also, the increased expense and delays associated with testing could result in decreased innovation, fewer new products, and higher prices (as have been claimed to have occurred with drugs under the 1962 amendments to the Food, Drug, and Cosmetic Act).- alndustry argues that the confidentiality of certain trade secrets (such as the identity of catalysts) is vital to maintaining the competitive balance within the 0.5. chemical industry. Even with the EPA's security provisions ’ for handling confidential data, individual companies are concerned that their lmpetitors will be able to uncover certain trade secrets from the test data which they are required to submit to the EPA. The EPA is required under TSCA to establish provisions for the sharing of test data on a reimbursible basis between firms seeking to market the same product. Companies are worried that this required sharing of test data might also provide their competitors with an opportunity for obtaining valuable trade secrets. Industry as a whole is concerned over its general inability to anticipate the specific testing requirements of TSCA. If testing requirements under TSCA are unavoidable, most companies would like to know as sooni as. possible which of their new chemicals will require testing (or at least what the specific selection criteria will be)“ and what tests will be required. Instead of general testing guidelines for new chemicals, industry generally appears to want to be" told exactly what tests would satisfy the EPA's requirements in order to alleviate some of their uncertainties. on the other hand, the EPA might be reluctant to be as specific as industry would like on new chemical testing because in so doing the EPA might lose some flexibility to cope with a variety of chemicals. Without the’ ability to tanticipate, industry will generally have more difficulties in .directing ,their .research and development programs toward producing the most promising, new chemicals- t‘However, for existing chemicals, industry has more of an incentive to produce less specific test results to make it more difficult to remove their products qfrom the market. ‘Small businesses and importers contend that they may have special problems t.der TSCA., Small businesses may be put at a competitive disadvantage if they are required to conduct as much testing as larger companies (which might be a disproportionate expense) or if any of their trade secrets are revealed (because a trade secret may be one of the only ways tthat a small business keeps ahead of its larger competitors). Importers are treated the same as CBS- 8 IB78050 UPDATE-01/16/80 manufacturers and processors under TSCA and may also~ be subject to its testing yprovisions. Because testing legislation is not uniform internationally, foreign companies might be subject to testing regulations only if they import a substance into the United States. H.B. 2606 (Scheuer) Amends the Toxic Substances Control Act to extend the authorization of appropriations contained in such Act through fiscal year 1980. Introduced Har. 5, 1979; referred to the Committee on Interstate and Foreign Commerce. Reported to the House from the Committee on Interstate and Foreign Commerce on may 15, 1979, with an amendment to require the Council on Environmental Quality to conduct a one—year study "to determine the adequacy of compensation and other assistance available to persons to mitigate ... losses caused by toxic substances." [H.Rept. 96-174]. H.B. 2606 was reported to the House again on June 21, 1979 [H.Bept. 96-174, Part II]. S. 11fl7 (Muskie) Amends the Toxic Substances Control Act to extend the authorization of appropriations contained in such Act through fiscal year 1982. Introduced, referred to the Committee on Environment and Public works from where it was reported to the Senate (S.Rept. 96-162), and placed on the calendar, all on may 15, 1979. was called up, considered, and passed the Senate on Hay 22, 1979. . ’ ‘ » §§A§£!§§ U.S. Congress.. House. Committee on Interstate and Foreign Commerce.» Subcommittee on Consumer Protection and Finance. Toxic substances control legislation - 1975. Hearings, 94th Congress, 1st session, on H.B. 7229, H.R. 75u8, and H.R. 7664. June 16, and July 9-11, 1975. Washington, 0.3. Govt. Print. Off., 1975. #82 p. “Serial no. 9H-91“ Reauthorization and general oversight hearings on the Toxic Substances Control Act. Mar. 8, 13, and 20, 1979. [not yet published] 70.5. Congress. House. icommittee on Interstate and Foreign ycommerce. Subcommittee on Oversight and Investigations. Chemical causes of cancer. Hearings, 95th Congress, 2d session. Jan. 23 and 26, Feb. 2 and 3, 1978. [not yet published] ' --+-r Environmental causes of cancer. Hearings, 9uth Congress, 2d session. May 28 and Sept. 20, 1976. Washington, U.S. Govt. Print. Off., 1977. 329 p. “Serial no. 94-141" -—-v- Regulation of cancer-causing flame-retardant chemicals and governmental coordination of testing of toxic chemicals. 1Hearings, 95th Congress, 1st session. May 11,1 cRs- 9 113730506 UPDATE-01/16/80 13, and 16, 1977. Washington, U.S. Govt. Print. Off., 1977. 521 p. "Serial no. 95-33“ Congress. House. Committee on Merchant Marine and Fisheries. Subcommittee on Fisheries and Wildlife Conservation and the Environment. »Polychlorinated biphenyls (PCBs). Hearings, 94th Congress, 2d session. Washington, U.S. Govt. Print. Off., 278 p. Hearings held Jan. 28-30, 1976. Congress. House. Committee on Science and Technology. Subcommittee on the Environment and the Atmosphere. The costs and effects of chronic exposure to low-level pollutants in the environment. Hearings, 9uth Congress, 1st session. Washington, U.S. Govt. Print. Off., 1975. 1&5? p. Hearings held Nov. 1975. 7, 10-1Q, and 17, Interagency regulatory liason group initiatives. Hearings, 95th Congress, 1st session. Apr. 25, 1978. [not yet printed] Congress. Senate. Committee on Commerce. Subcommittee on the Environment. .Toxic Substances Control Act. Hearings, 9uth Congress, 1st session, on S. 776. Mar. 3, 5, 10 and Apr. 15, 1975. Washington, U.S. Govt. Print. off., 1975. 362 p. i Congress. Senate. Committee on Commerce, Science, and Transportation. Subcommittee on Science, Technology, and Space. Oversight hearings on the implementation of the testing provisions of the Toxic Substances Control Act. Hearings, 96th Congress, 1st session.m Washington, U.S. Govt. Print. Off., 1979. 46 p. Hearings held May 4, 1979. "Serial no. 96-25" ---—%Proposed amendments to the Toxic Substances Hearings, 95thaCongress, 1977. [not yet published] Control Act 1st session. (5. 899 and S. 1069). Apr. 29 and hay 5, iToxic substances: contamination in uichigan.m session. Washington, U.S. Govt. Print. Off., 950 p. Hearings held Mar. 28, 29, and 30, 1977. “serial no. 95-28“ polybrominated hiphenyl (PBB) Hearings, 95th Congress, 1st 1977. Congress.« Senate. Committee on Environment and Public Works.m Subcommittee on Environmental Pollution. Oversight hearings on the Toxic Substances Control Act. July 20 and 21, 1978. [not yet published] ---- Beauthorization and general oversight hearings on the Hearings, 96th Congress, 1st 1979. 1147 p. Toxic Substances Control Act. session. Washington, U.S. Govt. Print. off., cas-10 1373050 UPDATE-01/16/80 Hearings held Mar. 19, 1979. "Serial No. 96-1010" 0.3. Congress. Senate. Committee on Government Operations. subcommittee on Executive Reorganization and Government Research. Chemicals and the future of man. Hearings, 92d Congress, 1st session. Washington, 0.3. Govt. Print. Off., 1971. 301 p. Hearings held Apr. 6 and 7, 1971. §£Q§!§-A§2_QQ!§E§§§LQ!éL DOQQEEEEE Train, Russell. Testing chemicals, not people: Bringing the chemical threat under control. In: Remarks of Lionel van Deerlin. Congressional record [daily ed.) v. 122, Mar. 2, 1976: H1080-H1483. 0.3. Congress. House. Committee on Interstate and Foreign Commerce. Legislative history of the Toxic Substances Control Act. December 1976. Washington, 0.3. Govt. Print. Off., 1976. 801 p. At head of title: 90th Congress, 2d session. Committee print. "Serial 0“ ’ 0.3. Congress. House. _Committee on Science and Technology. Subcommittee on the Environment and Atmosphere. Effects of chronic exposure to low-level pollutants in the environment. November 1975. Washington, 0.3. Govt. Print. Off., 1975. #02 p. A At head of title: 90th Congress, 1st session. Committee print. "Serial 0" A 0.3. Congress. House. Conference Committee, 1976. Toxic Substances Control Act (3. 3109); conference report. Washington, 0.3. Govt. Print. Off., 1976. 105 p. (94th Congress, 2d session. House. Report no. 90-1679/Senate. Report no. 94-4302) 0.3. Congress. Office of Technology Assessment. Cancer testing ptechnology and saccharin. Washington, 0.3. Govt. Print. Off., Oct. 1977. 149 p. [OTA-H-55] 0.3. Congress.’ Senate. Committee on Commerce. Toxic Substances Control Act.» 0.3. Govt. Print. Off., 1976. 90 p. (94th Congress, 2d session. Senate. Report no. 94-698) 0.5. Congress. Senate. Committee on Commerce, Science, and Transportation. Toxic Substances Control Act amendments. 0.3. Govt. Print. Off., 1977.. 25 p. (95th Congress, 1st.session.i 3enate.v Report no. 95-202) §§QEQLQ§X-QZ-EV§!I§ 07/26/79 —- The EPA published their proposed health effects , test standards for acute and subchronic toxicity, mutagenic effects, teratogenic/reproductive 06/2 1/79 -- 06/15/79 - 06/01/79 - 05/22/79.- O5/18/79 -- 05/15/79 -- 05/14/79 - CBS-11 IB7805O UPDATE-01/16/80 effects, and metabolism studies for TSCA test rules [44 FR 44054-93]. H.R; 2606 was again reported to the House from the Committee on Interstate and Foreign Commerce with House Report 96-17H, Part II. The Interagency Regulatory Liason Group added the USDA's Food safety and Quality Service unit as the group's fifth member [an ER 346u8]. The EPA published the fourth report of the Interagency testing Committee (ITC) along with a request for comments. The ITC added the following 11 substances and one category to its list of priority chemicals for testing: acetonitrile; aniline and chloro-, bromo-, and/or nitro-anilines; antimony; antimony sulfide; antimony trioxide; cyclohexanone; hexachlorocyclopentadiene; isophorone; mesityl oxide; 4.4!-methylenedianline; methyl ethyl ketone; and methyl isbutyl ketone [44 FR 31866-89]. S. 1147 was called up, considered, and passed the Senate. The Interagency Testing Committee transmitted its fourth report recommending priority chemicals for testing to the EPA which added 11 substances and one category of substances to its list. 5. 1147 was introduced by Senator Muskie, referred to the Committee on Environment and Public works, reported to the Senate from the Committee [S.Rept. 96-162] and placed on the calendar in the Senate.W S. 1147 is designed to extend the authorization for appropriations through FY82. H.B. 2606 was reported to the House from the Committee on Interstate and Foreign Commerce with amendment [H.Rept. 96-17%]. The EPA published its response to the Interagency Testing Committee's second report which added 8 recommendations to its list of priority chemicals for testing on Apr. 10, 1978. The EPA stated that it is not initiating test rules for the ITC's recommendations at this time because hit has not yet completed its review and evaluation 05/09/79 --i [nu ma 28095-98]. The EPA published their proposed health effects test standards for oncogenic effects, other chronic effects, and combined oncogenic and non-oncogenic, chronic effects for TSCA test rules as well as their proposed Good Laboratory Practice Standards for health effects.~ [#4 FR 2733M-75] ' 05/08/79 05/04/79 03/20/79 03/19/79 03/16/79 03/13/79 03/03/79 03/05/79, 01/31/79 V on TSCA with witnesses representing: CRs—12 IB78050 UPDATE-01/16/80 The Natural Resources Defense Council filed suit against the EPA claiming that the EPA did not meet its statutory requirements under TSCA for either developing testing rules or adequately explaining their reasons for not doing so for chemicals recommended for priority testing by the Interagency Testing Committee within the one year period required by TSCA. The Subcommittee on Science, Technology, and Space of the senate Committee on Commerce, Science, and Transportation held oversight hearings on the implementation of the testing provisions of the Toxic Substances Control Act. The Subcommittee on Consumer Protection and Finance of the House Committee on Interstate and Foreign Commerce finished its oversight and authorization hearings on TSCA with testimony from Representative John LaFalce and Steven Jellinek, the Assistant Administrator for Toxic Substances at the EPA. The subcommittee on Environmental Pollution of the Senate Environment and Public Works Committee held oversight and reauthorization hearings on TSCAE with Steven Jellinek, the Assistant Administrator for Toxic Substances at the EPA, as a witness. The EPA published a pre-proposal discussion of policy and technical issues concerning premanufacture testing of new chemical substances. [44 FR 16240-92] The Subcommittee on Consumer Protection and Finance of the House Interstate and Foreign Commerce Committee continued oversight and authorization hearings on TSCA with witnesses representing: the Chemical specialists Manufacturers Association, the Virginia State Health Department, the Natural Resources Defense Council, and the National Urban League. The Subcommittee on Consumer Protection and Finance of the House Committee on Interstate and Foreign Commerce held oversight and authorization hearings the Environmental Defense Fund, the Manufacturing Chemists Association, the New Jersey Department of Environmental Protection, and the Synthetic Organic Chemical Manufacturers Association.w H.R. 2606 was introduced by Representative Scheuer and was referred to the Committee on Interstate and Foreign Commerce. H.R. 2606 is designed to amend TSCA to extend the authorization for appropriations through FY80. The EPA published a revocation of their July 18, 01/10/79 - 10/30/78 - 10/26/78 - cas-13 IB78050 UPDATE-01/16/80 1978 rule which required submission of health and safety studies for the H substances and 6 categories Aof substances which were recommended by the Interagency Testing Committee on Oct. 10, 1977, for priority consideration for testing.‘ [an FR 6099-6100] The EPA published their proposed rules and notice forms for the premanufacturing notification provisions of TSCA which will go into effect 30 days after the publication of the inventory list. [44 PB 2242-2348] (signed and dated Oct. 23, 1978, by Steven Jellinek, Assistant Administrator for Toxic Substances) The EPA published the third report of the Interagency Testing Committee and requested comments on the one chemical substance (1, 2-Dichloropropane) and two categories of chemical substances (Chlorinated Benzenes, Tri-, Tetra-, and Penta- and Glycidol and its derivatives) which were added to the Committee's priority list. [43 PB 50630-4] The EPA published a notice in the Federal Register which outlined the EPA's current approach to implementing TSCA and invited public comment on such an approach. [#3 PB 50140-7] (signed and dated Oct. 10 by Acting Administrator Barbara Blum) the EPA published a notice in response to the Oct. H, 1977, Interagency Testing Committee recommendations for the testing of A 4 individual chemicals and 6 categories of 10/02/78 - 09/15/78«—— O1/20-21/78 chemicals, stating that, although the EPA has initiated review and evaluation of the Committee's recommendations, it has decided not to initiate rulemaking at this time. [43 PR 5013a-38] The TSCA Interagency Testing Committee submitted the second revision of its list of chemicals or groups of chemicals which the Committee recommends as priority candidates for health and environmental safety testing to the Administrator of the EPA, Douglas Costle.A The Committee added the following three groups of chemicals to its previous list of 8 chemicals and 10 groups of chemicals: chlorinated benzenes; tri-, tetra-, and penta-1, 2 dichloropropane; and glycidol and its derivatives.. The EPA extended the time limit for all persons who are required to submit lists and/or copies of health and safety studies from Sept. 18, 1978 (as published in the July 18, 1978 PR) to Oct. 16, 1978. [#3 FR H1206-7] —- Senate Environment and Public Works Subcommittee on Environmental Pollution held oversight hearings 07/18/78 04/25/78 OH/24/78 On/10/78 O3/16/78 o3/07/7e O2/03/78, o2/02/73 CBS-14 IB78050, UPDATE‘01/16/80 on the Toxic Substances Control Act. The EPA promulgated final regulations which require the submission of health and safety studies for the H substances and 6 categories of substances which were recommended by the Interagency Testing Committee on 10/on/77 for priority consideration for testing, effective Aug. 17, 1978. [H3 FR 30984-8] The House Committee on Science and Technology, Subcommittee on Environment and the Atmosphere held hearings on initiatives proposed by the Interagency Regulatory Liason Group in the area of environmental research and development. The EPA held a meeting to receive public comment on the draft procedures developed by the TSCA Data Security Force for the security of confidential business information submitted under TSCA. The TSCA Interagency Testing Committee submitted the first revision of its list of chemicals or groups of chemicals which the Committee recommends as priority candidates for health and environmental safety testing to the Administrator of the EPA, Douglas Costle [43 FR 76, 1668a-16688, Apr. 19, 1978]. The Committee added the following 4 chemicals and 4 groups of chemicals to its initial list of Q chemicals and 6 groups of chemicals (submitted 10/H/77): acrylamide; aryl phosphates; chlorinated napthalenes; dichloromethane; halogenated alkyl epoxides; polychlorinated terphenyls; pyrldine; and 1,1,1-trichloroethane. T The EPA published its interpretation of, and enforcement policy concerning the "substantial risk“ sections of TSCA [43 FR 52, 11110-11116] which requires that anyone who manufactures, processes, or distributes in commerce a chemical substance or mixture must inform the EPA .if they obtain any information that indicates that such substances may present a substantial risk of injury to health or the environment. The House Interstate and Foreign Commerce Subcommittee on Consumer Protection and Finance held oversight hearings on S. 1531 (which would amend TSCA to provide compensation for toxics injuries, to establish a chemical emergency response team, and to increase the authorization for appropriations) and on H.R. 9616 (which would establish a compensation system for victims of toxic substance pollution). The Subcommittee on Oversight and Investigations of the House Committee on Interstate and Foreign Commerce ufinished hearings on the chemical causes of cancer with witnesses from the FDA and the GAO. The Subcommittee on Oversight and Investigations of the House Committee on Interstate and Foreign 01/31/78 01/26/78 01/23/78 01/18/78- 01/12/78 01/01/78 11/18/77 1o/27/77 10/12/77 10/11/77 cns-15 1373050 UPDATE-O1/16/80 Commerce continued hearings on the chemical causes of cancer with witnesses from the Environmental Defense Fund and the Thermo Electron Corporation. The EPA published a proposed rule to require manufacturers, processors, or distributors of substances which_were recommended by the Interagency Testing Committee as priorities for health and environmental safety testing in their Oct. 12, 1978 Federal Register notice to submit health and safety studies which they know of on those substances [43 FR 4073-4076]. The Subcommittee on Oversight and Investigations of the House Committee on Interstate and Foreign Commerce continued hearings on the chemical causes of cancer with witnesses from the Cosmetic, Toiletry and Fragrance Association and the Environmental Defense Fund. The Subcommittee on oversight and Investigations of the House Committee on Interstate and Foreign Commerce began hearings on the chemical causes of cancer with witnesses from NCI and NIOSH. The EPA published a proposed rule to change the EPA procedures for dealing with requests for information under the Freedom of Information Act and to modify the basic procedures for handling business information obtained under TSCA and the Resource Conservation and Recovery Act, in the Federal Register [43 FR 2637+26u4]. The Interagency Testing Committee elected Dr. Marvin Stephenson as their second chairperson. Interim procedures for the handling of confidential business information submitted under TSCA went into effect. The EPA held a meeting to receive public comment on issues related to the EPA's development of procedures to insure the security of confidential business information submitted under TSCA. The National Institute of Environmental Health Sciences announced two new programs to help provide the manpower necessary to meet the mandates set forth in TSCA. These will include scientific training and investigator award programs in toxicology. ASteven*Jel1inek was confirmed by the Senate to be the Assistant Administrator for Toxic Substances at the Environmental Protection Agency. ' The EPA, CPSC, FDA, and OSHA published an interagency agreement to increase onégoing efforts to cooperate with each other to make the most efficient use of resources, achieve consistent regulatory policy, and improve the protection of the public health and the environment. CBS-16 IB78050 UPDATB—01/16/80 [a2 EB suass-7] 10/04/77 - The TSCA Interagency Testing Committee handed EPA's o3/o2/77 OSXOH/77 04/29/77 03/31/77 02/07/77 01/01/77 10/11/76 Administrator, Douglas Costle, its list of chemicals or groups of chemicals which the Committee recommended as priority condidates for health and environmental safety testing [42 FR 197, 55025-80, Oct. 12, 1977]. Although the Committee is allowed to recommend up to 50 chemicals or groups of chemicals, only the following 10 were recommended at this time: alkyl epoxides;walkyl phthalates; chlorinated benzenes mono- and di- chlorinated paraffins; chloromethane; cresols; hexachloro-1, 3-butadiene; nitrobenzene; toluene; and xylenes. v The Committee plans to expand and update its list as additional information is received. The EPA reproposed the inventory reporting regulations (first proposed Mar. 9, 1977) to expand the amount of information which certain chemical manufacturers and importers must submit for the compilation of the inventory list to include: the identity of each chemical substance manufactured or imported; the site of such manufacture; the amount of each such chemical substance manufactured or imported at each site; an indication of whether each such chemical substance is manufactured and used only within one site; and an indication of whether the respondent is a manufacturer, processor, and/or importer of each such chemical substance. This reproposal will cause the EPA to miss its statutory deadline of Nov. 11, 1977, for the publication of the inventory list and thus delay the premarket notification provisions of TSCA. Due in part to the similarity of their collective legislative mandates (including TSCA), the heads of the EPA, FDA, CPSC, and OSHA announced plans for joint agency initiatives to control toxic substances. The Science, Technology and Space Subcommittee of the senate Committee on Commerce, Science, and Transportation held hearings on S. 1069. witnesses included Representative. Rupee and representatives from the Sierra Club, Environmental Defense Fund, Environmental Action, and Natural Resources Defense Council. The science, Technology, and Space Subcommittee of the Senate Committee on Commerce, Science, and Transportation held hearings on S. 1069. witnesses were present from the EPA, HEW, and USDA. iwarren Muir was elected as the first chairperson of the Interagency Testing Committee. Thelnteragency Testing Committee met for the first time. TSCA became effective. 5. 3149 was signed into law (P.L. 9a-469) by President Ford.. cns-17 IB7805O UPDATE-O1/16/80 ,2-£ELQ!A£_§§§§§§!§§-§QQ§§§. Approaches for the development of testing guidelines under the Toxic Substances Control Act (preliminary report, 2d revised draft). Washington, D.C., The Conservation Foundation, Feb. 21, 1978. 44 p- Cancer and chemicals. Chemical and engineering news, Jan. 16 and 30, 1978: 34 - 40 and 30 - 35. Druley, Ray u., and Girard L. Ordway. The Toxic Substances Control Act. Washington, The Bureau of National Affairs, Inc., 1977. 409 p. EPA, TSCA team may be endangering a species: small chemical firms. Pesticide and toxic chemical news, Aug. 31, 1977: 20 - 22. Industry's TSCA fears are plant closings and disclosure of secrets. Pesticide and toxic chemical news, Aug. 31, 1977: 11 - 13. hagida, Arthur J. Toxic substances debate focuses on notification and testing. National journal. Feb. 14, 1976: 206-207. Wniller, Marshall Lee (editor). Toxic substances control. Washington, Government Institutes, Inc., Jan. 1978. 256 p. [Proceedings of the second annual Toxic Substances Control Conference, held Dec. 8-9, 1977, in Washington, D.C.] Hurray, Chris.v Chemical firms wary over toxic substances law. Chemical and engineering news, Jan. 3, 1977: 15-20. Toxic substances law: A quiet first year. Chemical and engineering news, Apr. 3, 1978: 16-17. National Academy of Sciences, National Academy of Engineering,’ Environmental Studies Board, and National Research Council, Committee on Toxicology. Principles for evaluating chemicals win the environment. A report of the Committee for working conference on principles of protocols for evaluating chemicals in the environment, HAS-NRC, Washington. 1975. 454 p. National Academy of Sciences, National Research Council. Decision 9 making for regulating chemicals in the environment. A report mprepared by the Committee on Principles of decision making for regulating chemicals in the environment. HAS-NRC, washington,. July 1975. 423 p. An Outline of TSCA [Toxic Substances Control Act]. Pesticide and toxic chemical news. Washington, 1976. sweeping EPA powers in new law. Dec. 1, 1976: 3-9. Key ponderable is scope of coverage. Dec. 8, 1976: 3-5. Government "coordination," the Achilles heel,of new law. Dec. 15, 1976: 3-9. Public involved in enforcement of new law. Dec. 22, 1976: 3-7. New law sets deadlines for EPA action. Dec. 29, 1976: 3-4. CBS-18 IB78050 UPDATE-0 1/ 16/80 Pelham, Ann. Government tackles tricky question of how to regulate carcinogens. Congressional quarterly, Apr. 22, 1978: 957-963. Reddig, William. Industry's preemptive strike against cancer. ‘Fortune, Feb. 13, 1978: 116-119. Setting priorities for chemicals under the Toxic Substances Control Act. Report of a workshop sponsored by the Conservation Foundation, Washington, and funded by EPA Grant no. T900629010. August 1977. 37 p. ‘ [ "Helm ont Report“) Should the Delaney clause be changed? Chemical and engineering news, June 27, 1977: 24-46. TSCA said to require ‘semi-qualitative shift‘ in 0.5. education system. Pesticide and toxic chemical news, Mar. 15, 1978: 19-20.: 0.3. Council on Environmental Quality. Environmental quality. Eighth annual report of the Council on Environmental Quality.m Washington, 0.5. Govt. Print. Off., December 1977. [Highlights toxic substances regulation and effects.) 0.5. Department of Health, Education, and Welfare. National Institute of Environmental Health Sciences. Human health and the environment - some research needs: Report of the second Task Force for Research Planning in Environmental Health Science. Washington, U.S. Govt. Print. Off., 1977. 498 p. [DHEW Publication No. (NIH)77-1277] --—- National Institute of Occupational Safety and Health. Registry of toxic effects of chemical substances. Washington, 0.8. Govt. Print. Off., 1976. 1245p. -~-- suspected carcinogens: a subfile of the NIOSH toxic substances list. Washington, 0.5. Govt. Print. Off., Dec. 1976. 251 p. ’0.S. Environmental Protection Agency. Administration of the Toxic Substances Control Act: first annual report (1977). Washington, January 1978. 17 p. 80.5. Environmental Protection Agency. Office of Toxic Substances. V An ordering of the NIOSH suspected carcinogens list based ’ "only on data contained in the list. Washington, March 1976. —-+- Summary tabulation of selected EPA activities concerning toxic chemicals. Washington, April 1976. 0.5. Library of Congress. Congressional Research Service. Science Policy Research Division. Environmental toxic chemical contamination incidents by state [by] Jo-Ann H. Hcflally. CR5 report. Washington, Dec. 30, 1977. .53 p. ---- Federal regulation of toxic substances [by] Jo-Ann H. Hcflally. CBS report.r Washington, Nov. 16, 1977. 11 p. ——--- Implementation of the Toxic Substances Control Act: CBS-19 IB78050 UPDATE-01/16/80 Overview [by] Jo—Ann M. Hcnally. (continously updated) Issue Brief 75051 will there be enough toxicologists? Chemical week. Nov. 17, 1976: 38-39.