Environmental Protection
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               TOXIC SuliSti'il'Ci'S
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SEPA
implementating the
Toxic Substances
Control Act:
Where We Stand

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    UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                   WASHINGTON. D.C. 20460
                      JUL 20 1378
                                      OFFICE OF TOXIC SUBSTANCES


       Implementing the Toxic Substances Control Act:

                       Where We Stand
Mandate
Scope
          TSCA gives EPA authority to identify and control
          harmful chemicals:  those already in commerce and
          new chemical substances prior to their commercial
          manufacture

          Responsibilities under TSCA include:

            , Requiring industry to provide information
               about the production, distribution, use,
               exposure, and health and environmental
               effects of chemicals

               Requiring industry to test potentially
               harmful chemicals for health and environ-
               mental effects

             Controlling chemicals that pose an unreason-
               able risk to health or the environment
          As many as  70,000 chemical  substances  are  currently
          in commerce

          Perhaps 1,000 new chemical  substances  will be
          introduced  into commerce annually

          Characteristics of U.S. chemical industry:

               Annual sales exceeded  $112 billion  in 1977

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               Chemical and allied products account  for
               approximately  6 percent of  the Gross  National
               Product

               An  estimated 115,000  establishments  involved
               in  manufacturing  and/or processing chemical
               products are affected by  TSCA

               The U.S. Chemical and Petroleum  Refinery
               industries  employ about 1.6 million  persons
                 the 170  largest companies account for  over
               80  percent  of  total industry employment

               The United  States maintains a  traditional
               trade surplus  in  chemicals, amounting to
               around $6 billion in  1975,  1976,  and 1977
Budget for TSCA
          FY 78 budget for toxic substances abatement and
          control is $22.9 million;  $41.6 million requested
          for FY 1979; as contrasted with $7 million in FY
          1977

          FY 78 budget for toxic substances enforcement is
          $2.3 million;  $4.6 million requested for FY 1979;
          as contrasted with $0.2 million in FY 1977

          FY 78 budget for toxic substances research and
          development is $3.6 million;  $10.5 million
          requested for FY 1979; as  contrasted with $1.4
          million in FY 1977
Implementation Strategy
          Key elements EPA considers fundamental to TSCA
          strategy in the early stages of implementation:

               Defining priorities for selection of chemical
               substances for early action

               Using actions under TSCA to further effective
               control of toxic substances under other laws

               Encouraging actions by industry,  beyond the
               actions directly required by regulation, to
               minimize risks from chemicals

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              Administering  the  several provisions of TSCA
              in a  coherent,  integrated way

             Considering  the total  risks  of  toxic sub-
              stances,  including global risks

          Basic  objectives  of initial TSCA  implementation
          activities include:

             Developing the organization  and staff  necessary
              to carry  out EPA's responsibilities under the
              Act.

             Defining  methods for assigning  priorities to
              chemical  substances requiring investigation
              or regulation

             Gathering information on the production,  use,
              exposure,, and  other basic characteristics
              of  important chemicals

             Developing testing standards for health and
              environmental  effects of concern, and issue
              rules requiring testing of  selected substances
              or classes of  substances

              Establishing a program for premanufacture
              notification and review of new chemical
               substances

               Regulating the production,  use, distribution,
               and/or disposal of selected substances or
               classes of substances
Organization and Staff

         EPA is developing several major new systems
          critical to implementation of TSCA:

               Mechanisms for effective review of new
               chemical substances under section 5

             Data systems for efficient retrieval

             Toxic Substances Priorities Committee,
               including senior representatives from
               other components of EPA

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          TSCA Abatement and Control  staff  in  the  Office
          of  Toxic Substances currently  numbers  about
          180 persons

              221 positions authorized  for FY 78
               (includes 31 in  Regions),  plus  6  for
              management

              428 requested for  FY  79  (includes 46  for
              Regions), plus 50  for  management

              99 actual for FY 77

          Enforcement  has  approximately  15  positions at
          Headquarters and another 18 in the Regions

              48 positions authorized  for  FY 78

              85 requested for FY 79

              3 actual in FY 77

          Research and Development is nearly full staffed
          as  FY  78 positions were reprogrammed from other
          ORD programs

              45 positions authorized  for  FY 78

              60 requested for FY 79

              10 actual  for FY 77
Determining Priorities
          A major immediate objective is to develop a
          'systematic method for selecting chemical
          substances for investigation or for
          regulatory action under TSCA

          In all decisions, risk will be determined
          by considering both the toxicity of a
          substance and its estimated exposure

          Chemical substances that may produce chronic
          health effects will take higher priority
          than those that produce acute effects

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               EPA will  emphasize  those  whose  effects  are
               either  irreversible or  slowly reversible
               and debilitating:   e.g.,  oncogenic,  rauta-
               enic, teratogenic,  and  neurotoxic  effects

               With  respect to  cardiovascular,  respiratory,
               inununological, dermatological,  and repro-
               ductive effects,  EPA will determine priorities
               based on the severity and irreversibility of
               the  effects

          EPA will  rely on  validated test methods that are
          generally  accepted by scientists

          EPA will  give high priority to the  environmental
          effects of substances that are widely dispersed
          into the  environment  and either indirectly
          threaten  human health,  affect commercially
          important species, or significantly  disrupt
          ecosystems


Information Gathering  Under Sections 8 and 12

         Initial inventory reporting regulations were
          promulgated  in December 1977 under  TSCA section
          8(a); deadline for reporting was May 1, 1978

         Objective of the inventory is to compile a list
          of chemical  substances as required  by TSCA
          section 8(b) and to establish a profile of the
          chemical  industry (what substances  are manufac-
          tured where and in what quantities)

             The inventory is expected to be published
               early in 1979

               Premanufacture notification program under
               section 5 will begin 30 days after publica-
               tion of the initial  inventory;  covers all
               new chemical substances manufactured or
               imported  (in bulk) into the United States

             Processors may add to the inventory during
               special 210-day reporting period  following
               publication of the initial version early
               next year

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     These  standards  vill be as consistent as
     possible with those already developed by EPA
     under  the Federal Insecticide,  Fungicide,  and
     Rodenticide Act

     To assure quality test data, the standards
     will include rules for Good Laboratory Prac-
     tices  that will  be modeled after those used
     by FDA

     The first standards  oncogenicity and other
     chronic effects   will be proposed this fall;
     others will follow throughout 1979

Through separate rules, the section 4 testing
standards will be applied to specific chemicals
and groups of chemicals

     These rules will be issued periodically once
     the testing standards are in place; the first
     such rule will be proposed late this year or
     early next year

     Chemicals and groups of chemicals subject to
     testing rules will be based on recommendations
     from the section 4(e) Interagency Testing
     Committee, EPA's own chemical selection pro-
     cess, and other sources

Interagency Testing Committee's  (ITC) initial
report to EPA  (October 1977) recommended that
priority consideration be given  to requiring
testing of four individual chemicals  (chloro-
methane, hexachloro-1,3-butadiene, nitrobenzene,
and toluene) and six groups  (alkyl epoxides,
alkyl phthalates, chlorinated  benzenes, mono-
and di-, chlorinated paraffins,  cresols, and
xylenes); by October 1978, EPA raust  initiate
action to require the recommended testing or
explain why  it  is not acting

   EPA will propose testing  rules  directed toward
     the effects to be evaluated; the rules will
     apply to various substances, as  appropriate

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          Second Interagency Testing Committee's report
          issued April 10 -- recommends priority testing
          consideration for another four individual chemicals
          and four groups of chemicals:  acrylamide, aryl
          phosphates,  chlorinated naphthalenes,  dichloro-
          methane, halogenated alkyl epoxiden,  polychlori-
          nated terphenyls, pyridine, and 1,1,1-trichloro-
          ethane; by April 1979,  EPA must initiate action or
          explain its reasons for not doing so
Establishment of Premanufacture Notification

         EPA will publish testing guidelines under section
          5 identifying the information it considers neces-
          sary to evaluate the risks associated with various
          classes of chemical substances

  9       Development 'of a system for reviewing premanu-
          facture notification is under way in anticipation
          of the beginning of notification early in 1979  (30
          days after publication of inventory)

  a       Rules for "significant new uses" will follow
          development of premanufacture notification require-
          ments
Regulation of Chemical Substances

  a       PCB marking :md riisp-'Sai rule a were :.Tomulgated
          February 17, 1973

         PCB regulations implementing the statutory ban on
          manufacture -\m: use in any way other than totally
          enclosed.marnar were proposed June 7, 1978

         Regulations on aerosol .uses of chlorofluorocarbons
          were promulgated Marcn 17, 1978, in a joint action
          with the Food and Drug Administration and the
          Consumer Product Safety Commission

         EPA is investigating ways to further reduce
          chlorofluorocarbon emissions by controlling non-
          aerosol uses (e.g., air conditioners, refrigerators,
          solvents), although eventual regulation will be
          under the Clean Air Act not TSCA

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          Ongoing reviews of high-volume, high-toxicity
          chemicals will produce other candidates for
          regulation over the next several months

          EPA will run pilot program to provide funds for
          public participation in rulemaking in connection
          with PCS ban regulations
State Cooperative Agreements
          $1.5 million is available in FY 78 and FY 79; it
          will be provided to States under cooperative
          agreements with EPA

          Funds will be used in a few States for priority
          programs for chemical risks for which EPA is
          unable or not likely to take action

          Criteria for these funds are being developed and
          will be proposed shortly; award of funds is
          expected in the first half of FY 79
Industry Assistance Office
          Established  in January  1977, as required by
          section  26,  to provide  technical and other non-
          financial  assistance  to industry on TSCA require-
          ments, compliance measures,  and Agency  policy

          Actions  to date:

                Letters

                +     Over 500  Congressional inquiries answered,
                     plus approximately 500 routine letters
                     (majority from industry) received monthly

                +     During the  4-month inventory  reporting
                     period, the letter average increased  to
                     3,000 per month with requests for
                     reporting forms and  instructions

                +     Grand total:   19,500 letters  over a
                     19-month  period

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              Telephone calls

              +    A  toll-free  number  installed  in January
                   1978 has  been  used  to  handle  6,050  calls'-

              +    Approximately  3,750 other  telephone
                   requests  for assistance have  been received

              +    Grand  total:   9,800 phone  calls over a
                   19-month  period

              Seminars/meetings

              +    Planned and  helped  conduct 32 TSCA
                   inventory training  seminars in 28 cities
                   between February 27 and March 17, 1978;
                   more  than 3,000  industry representatives
                   reached

              +    More  than 775  meetings with trade asso-
                   ciations  and industry representatives
                   held  (about  10 per  week over a 19-month
                   period)
Relations With Other Agencies

         Interagency Regulatory Liaison Group (IRLG)

               Was formed by EPA, FDA, OSHA, and CPSC in
               August 1977 to facilitate their combined
               effectiveness in conducting chemical control
               activities

               Eight working groups have been formed on  (1)
               regulatory development,  (2) testing standards
               and guidelines, (3)  information exchange,  (4)
               risk assessment,  (5) methodologies for
               epidemiological studies,  (6) coordination of
               enforcement and compliance strategies, (7)
               research needs, and (8)  interagency communi-
               cation and public education

               The results of these specific initiatives,
               which are currently ongoing, will be used to
               develop coordinated and  integrated approaches
               in these areas

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               In addition,  the tour agencies have begun to
               coordinate their activities in the 10 Federal
               Reg'ions

          Sections 10(b)(l)  and 25(b)  Interagency Toxic
          Substances Data Committee (ITSDC)

             Charge is to establish an EPA system fur
               collection, dissemination to other Federal
               agencies, and use of data under TSCA

               Basis will be EPA/CEQ survey of Federal
               agencies' toxic substances data needs
               and systems last year

             About 18 Federal agencies invited to
               participate

             Serves as mechanism for coordinating Federal
               toxic substances regulatory reporting and
               recordkeeping requirements

          TSCA Interagency Testing Committee

             EPA is a member and provides support as.
               required under  section 4(e)

             Purpose  is to recommend chemical  substances
               for priority consideration for testing  under
               TSCA

               Initial  recommendations made  in October  1977
               and April  1978

             Recommendations will be revised at least
               every  6  months; list not  to exceed 50 entries
               at any given time
Conclusions
          By end of FY 1979, all aspects of TSCA program
          will be in operation  although not each at  full
          capacity

               Priorities are being set to direct  implementation

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Initially more emphasis will be placed on obtaining
and analyzing information than on writing
specific control regulations

--   Information is needed for nonregulatory
     control and for regulation under other
     authorities as well as under TSCA

FY 1979 will concentrate on

     Premanufacture notification system

     Making priority-setting and information
     systems operational

     Developing testing standards and regulations

     Conducting hazard assessments

     Promulgating reporting and recordkeeping
     requirements

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