United States        Office of Pesticides      June 1987
             Environmental Protection    and Toxic Substances
             Agency          Washington DC 20460
&EPA      Toxic Substances
            Control Act (TSCA)

            Report to Congress
            for Fiscal Year 1986

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CONTENTS
1.     INTRODUCTION 	1

2.     HIGHLIGHTS 	3

       PROGRAM IMPLEMENTATION	3
         Enforcement	6
         International  Activities	.	6

3.     NEU CHEMICALS 	8

         Program Status	8
         PMN Review 	9
         Exemptions	12
         Test Data 	12
         Fol1owup SNURs	13
         Category Evaluations 	15
         PMN User Fees  	15
         Bi otechnology	16

4.     EXISTING CHEMICALS  	19

         Program Status 	19

         .RISK IDENTIFICATION 	,,	....-./		.'.... .20
           Section 8(c) Records	.,	24
           Section 8(d) Support  to Multiple Programs	25
           TSCA Chemical  Inventory Update Rule 	26
           CAIR	27
           Chemical Hazard Information Profiles (CHIPs) 	27
           Substitute Hazard Profiles	28
           Section 21 Petitions	...28
           Monitoring Activities	29
           Underground  Storage Tanks	32

         RISK EVALUATION 	33
           Chiori nated  Sol vents  	33
           Risk Assessments	34
           Pesticide Inerts Project 	35
           Chemical Emergency Preparedness Program (CEPP) 	36
           Chemi cal Category Evaluati on	36

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       RISK MANAGEMENT 	37
         Polychlorinated Biphenyls  	37
         TSCA Ground Water Protection Strategy  	39
         Quality Assurance 	39
         Asbestos	39
         ASHAA Asbestos Activities	»	44
         Referrals 	46
           1,3-Butadi ene 	47
           Glycol Ethers	47
           Toluenediamine	47
           MBOCA 	'	.48
           Formaldehyde 	.49
           Chloromethane 	49
         Significant New Use Rules  	•	49
           PBBs and tris	50
           1,2,3,4,7,.7-Hexachloronorbornadiene	50
           11-Aminoundecanoic  Acid	51
           HMPA and Urethane	51
           Pentachloroethane	52
           Methyl-n-Butyl Ketone	52
         Chemical Advisories 	53

5..   CHEMICAL TESTING-	,..		'.			55

      ' Program. Status  .,	...	—	;. .55
       Test Rule-Development	57
       Enforceable Consent Agreements  	64
       Quality of Data 	.'	•	64
       Test Guidel ines 	65

6.   SUPPORT TO OTHER  PROGRAMS,  REGIONS,  AGENCIES, STATES, INDUSTRY ...66

       Program Status	.66

       INFORMATION DISSEMINATION  	67
         Chemical Assessment Desk  	67
         TSCATS	67
         GEMS	68
         V1deos	68

       INDUSTRY COLLABORATION  	69

       TECHNICAL EXPERTISE	70

       STATE PROGRAM	71
         MINET	73

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 7.     COMPLIANCE AND ENFORCEMENT 	74

        PROGRAM ACTIONS 	74
        COMPLIANCE ACTIONS 	75
        CIVIL ENFORCEMENT ACTIONS 	76

 8.     LITIGATION 	'.	81

 9.     INTERNATIONAL ACTIVITIES  	92

10.     RESEARCH AND DEVELOPMENT  ACTIVITIES 	97

        MAJOR RESEARCH ISSUES	97
          Test Method Development	97
          Structure-Activity Relationships  (SAR)  	98
          Special  Human Data Needs 	98
          Ecology: Transport/Fate/Field Validation  	99
          Health:  Markers, Dosimetry,  and Extrapolation  	99
          Exposure Monitoring 	100
          Biotechnology/Microbial and  Biochemical  Pest Control  Agents  ...100
          Engineering Release and Controls  	101
          Ecology: Ecotoxicity and Risk Assessment	102
          Support	103

 TABLES                                                          .

 1.     Summary of New-Chemical  Actions:
        October 1, 1985-September 30,  1986	10

 2.     Summary of Existing Chemical Activities  	24

 3.     PCB Disposal Actions	38

 4.     Summary of Chemical  Testing Actions	58

 5.     Administrative Civil Actions Taken  under  Section 16
        of TSCA, Complaint's Issued, Cases Completed,  and
        Amounts Assessed (by Region)	80

 APPENDICES

 A.     Summary/Guide to Information Required by  Congress	104

 B.     Major FY 1986 TSCA Actions	109

 C.     Chemical Hazard Information Profiles (CHIPs)  ...;	120

 D.     Substitute Hazard Profiles	120
                                      111

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E.     Section 4 Test Studies Received 	121



F.     NTP Studies Received	121



G.     FY 1986 Section 21 Petitions 	122



H.     Summary of Research and Development Activities 	123

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 ABBREVIATIONS
 AAP      Ashestos  Action  Program

 ANPR     Advance Notice of  Proposed  Rulemaking

 ASHAA    Ashestos  School  Hazard Abatement  Act

 BSCC     Biotechnology Science Coordinating  Committee

 CAIR     Comprehensive Assessment  Information Rule

 CHIP     Chemical  Hazard  Information  Profile

 CMA      Chemical  Manufacturers Association

 CPSC     Consumer  Product Safety Commission

 EDF      Environmental Defense Fund

 FPA      U.S. Environmental Protection Agency

 FDA      Food and  Drug Administration

 FIFRA    Federal Insecticide, Fungicide, and Rodenticide
         Act

 FWS      U.S. Fish and Wildlife Service

 GLP      Good Laboratory Practice

 HF.SAP    Health and. Environmental   Studies  Audit Program

 HSWA     Hazardous and Solid Waste Amendments

 IPCS     International Program on Chemical Safety

 IRPTC    International Register of Potentially Toxic
         Chemicals

 ITC      Interagency Testing Committee

 NBM      National Rlood Network

 NCI      National Cancer Institute

 NFR      Notice of Final  Rulemaking

 NHATS    National Human Adipose Tissue Survey

 MIEHS    National  Institute of Environmental  Health Sciences

 NinsH    National  Institute for Occupational  Safety and
         Health

NPR.      Notice of Proposed Rulemaking

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NSF     National Science Foundation

NV'F     National Wildlife Federation

NOC     Noble Oil Company, Inc.

OFCD    Organization for Economic Cooperation
        and Development

OPTS    Office of Pesticides and Toxic Substances

ORD     Office of Research and Development

OSHA    Occupational Safety and Health Administration

OSW     Office of Solid Waste

OTS  .   Office of Toxic Substances

PAIR    Preliminary Assessment Information Rult.

PMN     Premanufacture Notification

RCRA    Resource Conservation and Recovery Act

SFIH    Service Employees International Union

SNIIR-    Significant New I ISP- Rule

TSC'A  '  Toxic Substances Control  Act

IINFP    United Nations Environment Program

WHO     World Health Organization
                                    VI

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1.  INTRODUCTION
         The Toxic Substances Control  Act  (TSCA),  enacted  in  1976,  provides
         the Environmental  Protection  Agency (EPA) with  the  authority  and
         responsibility to  protect  human  health  and the  environment from
         unreasonable risks arising from  the manufacture,  distribution,
         use, or disposal  of chemicals. .  This ninth annual  report  to
         Congress summarizes activities and  accomplishments  during  Fiscal
         Year 1986, and fulfills the Congressional reporting  requirements
         of TSCA sections  9(d),  28(c), and 30 (see Appendix  A).
              Through TSCA, EPA  seeks  to  prevent or reduce the  possibility
         of injury to the  public and the  environment from  harmful  chemicals.
         The authority of  TSCA allows  EPA  to evaluate and  regulate  a chemical
         at any stage in its life cycle  including  manufacture,  processing,
         commercial distribution, use  .and  disposal.  Programs have  been
         implemented to evaluate chemicals prior to commercialization
         through premanufacture  notification for new chemical substances
         and new uses of existing chemical substances (section  5);  to  evaluate
         existing chemicals by requiring  testing (section  4)  and reporting
         of unpublished health and  safety  data (section  8);  and to  control
         unreasonable risks of existing chemicals  through  regulatory
         action (sections  6 and  7). EPA  may also  refer  a  substance to
         another Federal agency  for action (section 9) in  the event that
         TSCA is not the most appropriate  mechanism for  controlling the
         particular situation.  In  any event, appropriate  control  actions
         are instituted after carefully weighing the risks posed by a

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substance against the benefits it provides and the associated
costs of regulation.
     As a result of these programs, data are being collected on
a number of chemical  substances subject to recordkeeping and
reporting rules*  Models have been created to calculate exposures
to various toxic substances, and surveys have been conducted to
determine current levels of exposure.  Test rules, and other
approaches to require industry testing where existing data are
inadequate, have been developed and are providing valuable toxicity
information to support risk evaluation.  Laboratory inspections
and data audits ensure the quality and integrity of data received
from industry as a result of chemical testing.
     To ensure compliance with regulations, TSCA authorizes both
civil and criminal penalties for violations..  Specific strategies'
and.tools have been developed and implemented to enforce TSCA
regulations.
     TSCA's ninth year of operation finds EPA enhancing the
existing chemical management process, coordinating cross-media
toxic evaluations, sharing TSCA acquired information with other
programs and Federal  Agencies, and expanding the use of TSCA
authority to contribute toward the solution of toxic problems
identified in various program media.

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2.  HIGHLIGHTS
PROGRAM  In FY 1986, EPA advanced all  areas  of implementation.   In  addition
IMPLEMEN-
TATION   to meeting the statutory requirements of the Act,  EPA  focused  on

         data management activities.   Major  efforts  were undertaken to

         share collected data and technical  expertise with  other EPA

         programs, Federal  agencies,  regions,  and States.

              FY 1986 was the first year that  TSCA authority  was used to

         address the chemical problems of other EPA  programs  and other

         Federal agencies.   The Comprehensive  Assessment Information Rule

         (CAIR) was developed under the authority of TSCA  section 8(a)  to

         consolidate many information-gathering requirements  into a

         single rule.  As proposed this rule will obtain information

         to support the assessment and regulation of 47 chemicals identified

         by EPA, OSHA, NIOSH, and CPSC; other  chemicals may be  added if

         necessary.  Additionally, the information collection authority

         of section 8(d) was used to  obtain  unpublished health  and  safety

         studies on 33 chemicals that are subject to the 1984 RCRA  amendments,

         and on another 107 chemicals which  were identified by  multiple

         users in EPA and CPSC.  Section 4 was also  used for  the first

         .time to acquire test data on a chemical, 1,1-dichloroethylene,

         that is being investigated under the  Clean  Air Act.

              TSCA data supported the Chemical Emergency Preparedness

         Program (CEPP) that was developed in  FY 1986 to address sudden

         accidental releases of chemicals that are potentially  acutely

         hazardous.  TSCA data bases  were also used  to help develop an

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acute hazard list, of 4fi? toxic substances; these were identified



as chemicals that could potentially cause serious human hpalth



effects from short-term pxposure.



     Tn FY 1Q%, the Agency promulgated the Inventory Updatp ^ule



requirinq manufacturers and importers to report currpnt production



volume and site data on many of the more than K£,nnp chemicals



that are on the TSCA Chemical  Substances Inventory.  Thp rule



reprpsents the first update since 1Q77, and includes new



substances that have been added to the Inventory after r°view



under section 5.  Current production volume and site data are



imperative in estimating new and existinq chemical exposure?..



     The New Chemicals program continues to he one of FPft's



ma.ior tools in prpventinq future health and envi ronmpntal problems.



In FY 1986, the Agency received ?,?!.?. new ckpmir:al substance



notices.'  This is the highest  annual volume received since the



program's incept'ion in 1^79, whrch ^rinos the total number



received to date to £,511.  Mew chemical substance notices



include premanufacture notifications (PMNs), as well as



polymer PMMs, low volume exemption notices, and test market



exemption applications:.  Under section F(e) this ypar, FPfl



issued more orders directed to new chemicals than in any other



year.  The testing requirements that were imposed on PMN submitters



last year are beginning to yield toxicity data that support the



evaluation of new substances,  and enhance rPA's ability to protect



human health and the environment from unreasonable risk.

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     Criteria designating certain new biotechnology substances
as new chemical substances were developed, as well  as scientific
tools to assess the risks of these substances.  Throughout FY
1986, EPA continued to work closely with Federal  agencies and
international organizations on biotechnology issues.  A Statement
of Policy was published in June 1986, describing how five Federal
agencies will use existing laws to ensure protection of human
health and the environment from biotechnology research and
products.
     Asbestos continues to be a priority concern at EPA, with
emphasrs on worker protection requirements for asbestos abatement
activities in schools and buildings.  In April 1986, EPA published
                          *
a final  rule effectively extending the protection of the OSHA
Asbestos Standard to State and local asbestos abatement workers
outside of OSHA-jurisdiction.  In January 1'986, EPA proposed a
rule which would ban the manufacture, import and processing of
certain asbestos products, and phase out the use of asbestos in
other products.  All products that are not immediately banned
would have to be labeled as containing asbestos.  EPA also
produced several guidance documents that incorporate the latest
information on asbestos control and abatement activities.
     The Chemical Testing program introduced a new approach of
using enforceable consent agreements as an alternative to test
rules, when consensus can be reached on testing.  This approach
will expedite testing, while providing, safeguards equivalent to
those of test rules.

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Enforce- In FY 1986, EPA continued to enforce the provisions of TSCA through
ment
         inspections and by issuing civil  and criminal  compliants where
         violations were identified.  This fiscal year, EPA inspections
         focused on PCBs (1,639 inspections), and asbestos in schools
         (2,393 inspections).  In addition, the Agency  conducted. 1,005
         inspections on chemical  substance imports, 393 inspections on
         new chemicals, 452 inspections for compliance  with reporting and
         recordkeeping under TSCA section 8, and 16 inspections of labor-
         atories for compliance with Good Laboratory Practices (GLPs).
              In the enforcement area, 781 civil complaints were issued.
         The majority of these were for- asbestos-in-schools (425) and PCB
         (323) violations.   In FY 1986, the Agency also issued complaints
         for violations of section 8(a) of TSCA (2), for TSCA section 13
         import requirements. (23), and. TSCA section.5 (3).

Inter-   In FY 1986, EPA" continued to actively participate in international
national
Activi-  programs.  Good Laboratory Practice (GLP) experts met and reached'
ties
         agreement on two documents:  the Guide for Compliance Monitoring
         Procedures for Good Laboratory Practice, and Guidance for the
         Conduct of Inspection and Study Audits.  A group of experts met
         twice in FY 1986 regarding the exchange of confidential information.
         The group designed a model form for bilateral  agreements as well as
         guidance for countries negotiating such agreements.  The Chemical
         Information Switchboard continued its operations during FY 1986
         and increased access to unpublished information on chemicals for
         its member States.  Also during FY 1986, four new test guidelines
         in genetic toxicology were adopted by the OECO Council; the Updating

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Panel endorsed revisions to three acute toxicity guidelines,
primarily as a result of concern for animal  welfare.

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3.  NEW CHEMICALS
.Program  The goal of the new chemicals program is to protect human health
Status
         and the environment from the harmful effects of new chemical substances,

         New substances are defined as those which do not appear on the TSCA

         Chemical Substances Inventory.

              Under section 5(a) of TSCA, manufacturers are required to

         provide FPA with a premanufacture notification (PMN) 90 days prior

         to manufacture or import of a new chemical substance.  Following

         EPA's review and evaluation of the PMN, if information available

         to EPA is insufficient to permit a reasoned evaluation of the

         substance, and EPA-determines that the activities may present* .

         an unreasonable risk of injury to human health or the environment

         or that the substance will he produced in substantial quantities and

         will resu.lt in significant nr substantial human exposure or

         substantial release to the environment, .a section 5fe) order-may

         be issued to limit or prohibit manufacture, .import, processing,

         distribution in commerce, use, or disposal of the substance,

         pending development of the test data needed to evaluate the

         potential hazard.

              Regulations under section R also require manufacturers to sub-

         mit a Notice of Commencement of Manufacture after PMN review,

         when actual manufacture begins, at which point the new suhstancp

         is added to the TSCA Chemical Substances Inventory.

              Additionally, EPA may monitor new and existing substances

         that could be of concern should their uses change or production

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         volume increase significantly,  via  significant  new  use  rules



         (SNURs).   Under a SNUR,  any  person  who  intends  to manufacture  or



         import a  substance for a designated "significant  new use"  would



         be required to submit a  notification for EPA  review much  like



         a PMN.



              Although the new chemicals program has  become  increasingly



         effective, the growing volume of PMNs,  has  necessitated new  procedures



         to streamline and standardize the review process.   In FY  1QR5,  for



         example,  EPA implemented two exemption  rules  which  shortened the



         review period for certain polymers  and  low  volume chemicals.



              Total new chemical  substance submissions,  which include



         PMNs, Tow volume exemption notices, polymer PMNs, and test market



         exemption applications,  reached ?,?13 in FY  1986  fa 20"? increase



         over the  1,784 in FY 1985).



PMN Review



         Since the beginning, of the HPW chemicals program  in 1979,  FPA  has



         received  7,356 valid PMNs.  In FY 1986, EPA  received 1,693 PMNs,  thP



         greatest  number received in  a sinale year.   Most  of the new  substances



         reviewed  did not reguire regulatory action.   The  Agency took action



         on the remainder according to several renulatory  options  available



         under TSCA section 5.  EPA issued 49 section  5(e) orders  controlling



         exposure  to 67 substances, pending  development  of additional data.



         In addition, 45 PMNs were withdrawn by  their  submitters in anticipation



         of EPA action under section  5(e) or 5(f).  Table  1  summarizes  new



         chemical  actions.

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             Table 1

 Summary of New Chemical Actions
October 1, 1.985-Septemher 30, 1986
Actions
Total Mew Chemical Substance Submissions Received
(PMNS;._Iest Market, Polymer, and ^
Low Volume r — "
^ s <
Valid PMNs Received
PMMs Requirinq No Further Action
Voluntary Testing in Response to FPA Concerns
Voluntary Control Actions by Submitters
PMNs WitHdrawn in Face- of 5(e)/5(f)
PMNs Subject to section 5(e) Consent Orders*
PMMs Subject to Unilateral section ^fe) Orders*'
PMNs 'Subject to section -5 ff) Rules
Number of Chemicals for which Commencement of
Manufacture Notices Were Received
Submissions of Bona Fide Intent to Manufacture
New Substances Subject to Proposed Siqnificant
New Use Rules
New Substances Subject to Final Significant
New Use Rules
Test Data Received as a Result of Section R(e)
Consent Orders
Valid Test Market Exemption Applications Received
Granted
Withdrawn
Denied
No. of
Actions
in FY'86
2,213.
1,693
1,414
18
0 .
47
66
. 0
o
1,098**
543
13***
1***
25
56
48
7
0
Aqareqated
Total To
Hate fsince
-mid-107Q)
8,511
7,35fi*
^,7fi! '
fi4
33
139
27! a
. 1.2
4
3,678
?,631
B5
15
?5
4?7
377
40
6
            10

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Polymer PMNs Received                                 233           387

Granted                                               198           32*

Withdrawn                                              35            RR


Low Volume Exemption Notices Received                 ?34           31.fi

Granted                                               223           298

Withdrawn       -                                        8            11




a Includes lOfi synfuels.

*A section 5(e) consent order is issued hy FPA with the agreement of the PMN
submitter.  A section 5(e) unilateral order is issued hy FPA without the aoreement
of the PMN submitter.

**This number includes PMNs received in previous fiscal years for which commence-
ment of manufacture notices were received, in FY-1986-.

***This number includes substances which were the subjects of PMNs receivpH in
previous fiscal years but for which proposed-or final rules were not published
until  FY 19PR..
                                       11

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Exemptions  Certain requirements for exemptions from PMN review or from the
            full  90-day PMN review process were written into the statute.
            These include exemptions for research and development (R&D), and
            test  marketing exemptions (TME).  Substances manufactured
            solely for R&D are exempt from PMN review.  However, manufacturers
            of R&D substances must meet requirements set forth in a final rule
            published in April 1986, clarifying R&D provisions.
                 New substances produced for limited test marketing are subject
            to an abbreviated 45-day review..  A test marketing exemption
            application must be submitted for EPA review prior to commencement
            of test marketing activities.  If a manufacturer subsequently
            wishes to commence full-scale commercialization of the new- substance,
            a PMN must be submitted for -a full 90-day PMN review.
                 Other exemptions from full  PMN review have been created by
            regulation-..  These include exemptions, for certain polymers and low
            volume substances.  Polymer PMNs and low-volume exemption notices
            are subject to a 21-day review period.
                 These actions are summarized in Table 1.
   Test
   Data     EPA may ask for pre-production testing if this can be done quickly
            and without unreasonable expense, or if the Agency has reason to
            suspect that potential risk may not be adequately characterized.
            EPA can issue section 5(e) orders with "testing triggers" if the
            potential risk can be controlled until  a substance reaches a
            predetermined production volume; production above the stipulated
            volume requires that test data be submitted.  In FY 1986, EPA
                                      12

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         issued 12 section 5(e) consent, orders with testing triggers.

         Test data, prompted by section 5(e) consent orders, were received

         on 25 PMN chemicals.  These test data have additional  value,  as

         the data are shared with other FPA programs.

Followup
SNURs
         'TSCA authorizes FPA to monitor new and existing substances that

         may be.of concern if their uses chance, or if production volumes

         increase significantly from those estimated in the PMN.  Under

         TSCA section 5, EPA may determine by rtilf that certain uses of

         chemical substances are significant new uses.  These rules are

         referred to as significant new use rules (SNUPsU  In  manna such

         a determination, the Agency considers the potential exposure

         associated with thp us.*3, *"he toxicity associated with  the substance

         and whether the use is ongoing at the time-the rule is proposed.

         Persons subject to a SNUR must notify FPA at least Q0  days hpfnro

         manufacturing, import!no, or processinq the chemical substance

         identified in t>e SNUR for the defined significant new use or uses.

              A SNUR may be issued for any TSr.A chemical substance, includina

         individual substances and chemical categories, and for new or

         existing substances.  A SNUR may be written in conjunction with a

         section 5(e) order.

              A section 5(e) order can limit or prohibit the use of the

         chemical substance that is the subject of a SNUR.  Once commercial

         manufacture of a new substance begins, it is placed on the Inventory.

         If no SNUR is issued, this substance may he manufactured, processed
                                     13

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or used hy others without any restrictions.  To establish equity nf
treatment, EPA issues SNURs on new substances .which are subject 1
section 5(e) orders, thus requirina other persons who intend to
manufacture the substances to notify EPA before manufacturino,
importing, or processing the substances for any activity other tl
those specifically permitted in the section 5(e) order.
      The Agency also writes followup SNURs for certain new su^s'      ;
which were not subject to section 5(e) orders.  These SNURs address
concerns which had not ori.ginally triggered a section 5(e) order
either because the concerns arose after the completion of the PMN
review, or because-the uses described in the PMN did not' involve
enough exposure to warrant action.  Followup SNURs allow the Aoency
to permit safe uses of potentially hazardous new substances, while
ensuring that it Has the- opportunity to review uses which may lead
to. signi-f-icant changes in human- or environmental exposure. . •
      Additionally, EPA develops SNURs which support the existing
chemical program's risk assessment an-d risk management activities by
monitoring significant new uses of substances that are on the TSCA
Chemical Substance Inventory.  These SNURs enable EPA to take immediate.
followup control action to limit potential exposure resultinq from
significant new uses of existing chemical substances.
     EPA proposed 8 SNURs covering 13 PMN substances in FY IPflfi and
promulgated 1 SNIIR covering 1 PMN substance (see Appendix B).
     In addition to the SNURs on PMN substances, EPA proposed 5 SNURs
on 1? existing substances, and promulgated 4 SNURs on 4 existing
                                 14

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                chemicals under the authority of section 5 (see Appendix  B and

                Chapter 4).
Category
Evaluations          Until  FY 1986, new and existino chemical  SNDRs were  developed

                on a case-by-case basis, tailored to meet specific circumstances.

                In April  1986,  EPA introduced the listing SNUR for acrylate

                substances.  That SNUR, as proposed will  establish in  the Code

                of Federal  Regulations (CFR) a list of the significant new uses  the

                Agency routinely designates for acrylates and  a list of recnrdkeeping

                provisions  the  Agency requires for those significant new  uses  in a

                chart format.  The chart will contain the name of the  substance,

                references  to the appropriate significant new  uses selected from the

                established standard list, and references to the applicable record-

                keeping requirements'.  F'ach time a SNUR is issued for  an  acrylatp

                substance an addition will he made to the chart..  This SNHP eliminates

                the development of new significant new use triggers each  time  an

                acrylate SNUR is proposed..  By means of this mechanism, the Aciency

                hopes to speed  up the process of issuing SNURs for acrylates and to

                make those  SNURs more uniform.


  PMN           EPA is planning to use the authority of section ?6(h)  to  require
  User
  Fees          a fee for premanufacture notifications, exemption applications and

                notices, and significant new use notices submitted under  TSCA

                sections 5(a) and (h).  The Agency prepared a  paper that  discussed

                options for setting a fee and provided preliminary estimates of the

                economic impact of such a fee.  The Federal Register announced the

                availability of the "Options for PMN Fees" paper in July  1986,

                soliciting  comments on the options it presented.  Subsequently,

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              a proposed rule has been developed that will  propose the fee option
              of $100 for section 5 premanufacture notices  submitted by
              small  business concerns, $100 for low volume  exemption notices,
              $100 for test market applications, and $2,500 for all  other
              section 5 notices.   The proposed rule will  be published in
              FY 1987.

Biotech-      In June 1986, a Statement of Policy was published describing.
nology
              how five Federal  agencies will  apply their respective authorities
              to biotechnology  research and products in order to protect human
              health and the environment from potential hazards.  Each of the
              five agencies is  charged with assessing a portion of the risks and
              benefits resulting  from artificial manipulation of the genetic
              structures of plants,, animals or microorganisms.   Existing Federal
              laws will then provide a basic network of jurisdiction over.-both
              research and products-
                   Five agency-level committees have been formed.  The purpose of
              EPA's agency-level  advisory committee is to provide advice on
              scientific issues pertaining to biotechnology.  The EPA Bio-
              technology Science  Advisory Committee is comprised of 11 members,
              nine from the scientific community; the other two representing
              general public policy issues.
                   On July 9, 1986, the first public meeting of the Biotechnology
              Science Coordinating Committee (BSCC) was held in Washington, D.C.
              The Committee received oral comments from the public on the Federal
              biotechnology policy.  The BSCC was established on October 31, 1985,
                                       16

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and consists of senior policy officials from the agencies involved



in the oversight of biotechnology research and products.   It is



authorized to hold public meetings in order to discuss public



concerns about issues involving biotechnology.  The Committee was



formed by the Federal Coordinating Council for Science, Engineering



and Technology, a statutory interagency coordinating mechanism



managed by the Office of Science and Technology Policy, which



operates out of the Executive Office of the President.  Its mission



is to coordinate science activities among Federal  agencies.



     EPA is responsible for regulating microorganisms used as



pesticides, or for general industrial or environmental purposes.



EPA's biotechnology policy gives special consideration to three



categories of microorganisms: 1) microorganisms that contain new



combinations of traits, or'that are new to the environment in



which they are used; 2)  microorganisms that are pathogens, or



contain genetic material from pathogens, except those that are



native to the area where they will be released; and 3)  all other



microorganisms that are subject to the Federal Insecticide, Fungicide



and Rodenticide Act or TSCA, and are deliberately released into the



environment.



     Microorganisms altered to contain genetic material from



dissimilar source organisms through deliberate human intervention



(intergeneric microorganisms) are considered "new" and are therefore



subject to premanufacture notification requirements if they are



manufactured for TSCA purposes.  This policy became effective when



the Statement of Policy was published.
                            17

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     Testing in the environment of "new" (inter-generic) micro-
organisms will not fall under the R&D exemption from the PMN
process that is accorded to other R&D substances.  Thus, persons
developing "new" microorganisms for commercial purposes will be
required to notify EPA prior to environmental releases.  Rulemaking
will be required to fully implement this component of EPA's policy;
until the necessary rule changes are promulgated, EPA expects to
be voluntarily notified of such uses.
     Because of its concern that certain microorganisms will not
be subject to PMN policies but should nonetheless be reviewed, EPA
expects to complement its PMN policy with a requirement to be notified
prior to new environmental uses of genetically engineered micro-
organisms that are pathogens or contain genetic material from
pathogens.  This would be accomplished through a "significant new
use rule" issued under section 5(a)(2) of TSCA.  Again, until any
rule is promulgated, EPA expects" to be-notified, of such releases
on a voluntary basis.
     The Agency intends to require that some information be reported
to EPA prior to all environmental uses of microorganisms that are
subject to TSCA but not subject to the PMN or significant new use
requirements described above.  To accomplish this, EPA intends to
promulgate a rule under the authority of section 8(a) of TSCA.
     EPA also intends to consider an exemption from PMN requirements
for "new" microorganisms used solely in contained systems and
never intentionally released to the environment.
                            18

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     EPA must be notified by manufacturers, processors or distributors
of microorganisms immediately if they become aware of any new
information that suggests that any microorganisms present a substantial
risk of injury to human health or the environment.  This is not a
new requirement; it applies to all substances subject to TSCA.
                            19

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4.  EXISTING CHEMICALS
Program  The goal  of the existing chemicals program is to reduce unreason-
Status
         able risks of injury to health or the environment from chemicals
         already in commerce.  The objectives of this program include
         identifying potential  risks to public health and the environment,
         evaluating those risks, and when appropriate, addressing those
         risks with regulatory actions under TSCA or another relevant
         authority.  TSCA addresses all phases of a chemical's life cycle,
         including manufacture, processing, distribution,..use, and disposal.
              To identify potential risks, EPA uses the authority of TSCA
         section 8 to gather information about exposure and toxicity of
         particular chemicals-  When data, are unavailable or insufficient,
         TSCA section 4 authorizes EPA to require testing by manufacturers
         and processors..
              The Agency makes' a risk assessment of a given--chemical based on
         analysis of exposure data and health and environmental effects data.
         From the available information and the risk assessment, EPA makes
         a decision regarding the need for risk management actions.  Alternative
         risk management actions are identified and evaluated, considering
         effectiveness and cost factors.  The. Agency focuses its efforts
         on the potential risks of greatest concern and implements the
         appropriate risk management actions.  Provisions of section 5 (i.e.,
         significant new use rules), as well as nonregulatory tools (such
         as chemical advisories) can be used to monitor or warn of situations
                                     20

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           which raise some concern, hut do not necessitate immediate

           regulation.  FPA can control  unreasonable risks through regulatory

           action under the authority of section fi, or require immediate

           elimination of any imminent hazards under section 7.   When TSCA

           is not the most appropriate mechanism for given exnsotire or

           risk situation associated with a chemical  of concern,  that chemical

           will be referred to another Federal authority for action under

           section 9.

                Only those chemicals with identified unreasonable ri'sks  are

           addressed in all phases of the program descrihed above.  Chemicals

           that are not found to pose unreasonable risks are drooped from

           further evaluation; resources are reproqrammed into evaluation of

           potentially more hazardous chemicals.

                Ourinq FY 19flfi, 76 chemicals were considered in  the Fxistinq

           Chemicals Program review process,  flf that number, fi  were referred

           for information .qathering rules includino testing, and ^1 are

           undergoing further evaluation.  Table ? summarizes existing

           chemical program activities.

Kl 3N
IDENTI-
FICATION
           The authority of TSCA section P allows FPA to require reporting

           and recordkeeping relating to chemical substances and mixtures.

           Section 8(a) allows FPA to promulgate rules that require manufacturers,

           importers, and processors to maintain records and report certain

           information to the Agency.  The section P(a) Preliminary Assessment

           Information Rule (PAIR) requires manufacturers and importers  of the

           chemicals that it specifies to report general.production, use and
                                      ?\

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exposure information using the rule's Report Form.   These data are
especially important to the Agency's review of chemicals designated
by the Interagency Testing Committee (ITC) for priority testing
consideration.  EPA may also add non-ITC chemicals  to the rule.
In FY 1986, EPA developed the Comprehensive Assessment Information
Rule under section 8(a), designed to consolidate a  comprehensive
list of reporting provisions and questions into a model rule.
This rule is expected to reduce duplicative efforts within EPA and
other Federal  agencies as well as industry reporting burdens.
This information must be provided to EPA upon request.  Under
section 8(c),  manufacturers and certain processors  must maintain
records of alleged "significant adverse reactions".  In FY 1986,
EPA required s-ubmission of such records for the first time.
Amendments to EPA's section 3(c) rule in FY 1986 exempt coincidental
manufacturers of substances and revise the description of processors
Section 8(d) requires certain manufacturers, importers, processors,
and distributors to submit lists of unpublished health and safety
studies to EPA.  In FY 1986 EPA amended the model Health and Safety
Data Reporting rule.  This model rule requires past, current,  or
prospective manufacturers, importers and processors of certain
named substances to submit unpublished health and safety data  to
EPA.  EPA adds substances to the model rule as the Agency
identifies a need for health and safety information.  Under
section 8(e), persons who obtain new information that reasonably
supports the conclusion that a substance or mixture which they
manufacture, import, process or distribute presents substantial

                            22

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risk of injury to human health or the environment must notify
EPA within 15 workinq Days.  These notices are then reviewed and
an initial evaluation (status report) is prepared containing,
if appropriate, follow-up questions to the submitter,  referrals to
other agencies, and recommended EPA followup actions.   The Aqency
also receives a large numher of "For Your Information" (FYI)
submissions, submitted voluntarily to the Aqency on chemical
toxicity and/or exposure.  FYIs are submitted by chemical
manufacturers, processors and distributors, trade associations,
labor organizations, Federal, State or local anencies, foreign
governments, academia, public interest and environmental  cirouns,
as well as by the general public.  Another source of data  on
existing chemicals risks is the National Toxicology Program, from
which test data are routinely received and reviewed.
     In FY 1986, the existing chemicals program- received and
reviewed a substantial amount of.data on existing chemicals
(see Table 2).  During the fiscal" year, section 8(a) and
8(d) rules were amended to require reporting on 160 chemicals.
Section 8(a) and section 8(d) rules resulted in submission by the
chemical industry of 362 studies and reports on existing chemicals,
Under the section 8(e) substantial risk notification proqram, FPA
received 66 initial submissions, 125 supplemental/followup
submissions to previous section 8(e) initial reports,  and 20F
"For Your Information" submissions, totalling 3% for FY 1986.
A total of 97 completed test studies required under section 4
were received from industry  (see Appendix F.).  Twenty-one National
Toxicology Program studies were also received and reviewed (see
Appendix F).

                            23

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                                             Table 2
                             Summary of Existing Chemical  Activities
     Risk Identification                                              # in FY 1986

     Section 8(a) Preliminary Assessment Reports Received                      31
     Section 8(d) Health and Safety Studies Received                          331
     Section 8(e) Substantial Risk Notification Program:
       - Initial  8(e) Submissions        .                                      66
       - Supplemental/Followup 8(e) Submissions                               125
       - "For Your Information" (FYI) Submissions                             205
     Chemical Hazard Information Profiles (see Appendix C)                     10
     Substitute Hazard Profiles (see Appendix D)                               17
     Testing Studies Received under Section 4 (see Appendix E)                 97
     National Toxicology Program Studies Reviewed (see Appendix F)              21
     Section 21 Petitions Received (see Appendix G)                             5

     Risk Evaluation                                                  # in FY 1986

       - Continued assessment                                                  51
       - Referred for risk management                                           3
       - No further action required                                            13.
       - Section 4(f) designations'                                              0
       - Referred for information gathering                                     6

     Risk Management                                                  # in FY 1986

     Proposed and final  rules under section 6                                   3
     Proposed and-final  rules under section 6(e)                                1
     Chemical' Advisories                            .                            2'
    •Proposed and final, significant:, new-use. rules                               9
     Sect.ion 9 Referrals                                                        5


Section       EPA published a TSCA section 8(c-) regulation in August 1983,
8(c)
Records       requiring manufacturers and certain processors of chemical

              substances and mixtures to keep records  of significant adverse

              reactions to health and/or the environment alleged to have been

              caused by a substance or mixture.  In FY 1986, for the first time

              since the 8(c) regulation became final,  EPA required submission

              of such records.  Two sets of records were submitted on poly-

              fluorinated or partially fluorinated compounds used in preparations

              for water and stain repellent treatment  of porous materials.  The
                                          24

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Section 8(d)
Support to
Multiple
Programs
Agency used these submissions to determine if the compounds showed
similar effects to others observed in animal  toxicology studies.
EPA promulgated a final rule under section 8(d) of TSCA to collect
health and safety data for the Office of Solid Waste (OSW).  This
rulemaking marked the first time that OTS specifically developed
a rule under TSCA authority to collect information needed for
another EPA program.  The rule requires past, current, and
prospective manufacturers, importers, and processors of 33 chemical
substances to submit lists and copies of unpublished health and
safety studies on those substances to EPA.  The mandates of the
Hazardous and Solid Waste Amendments of 1984 (HSWA) prescribe
statutory deadlines by which EPA must develop land disposal
restriction regulations for certain substance-s that are subject
to the Resource Conservation and Recovery Act (RCRA).  If these
deadlines are not met, the HSWA impose an automatic ban on the
land disposal of the substances.  OSU is devising treatment standards
with regard to which health and safety data on the 33 substances
are needed.
     In August 1986, EPA proposed another section 8(d) rule adding
107 chemical substances nominated by EPA's Office of Drinking Water,
Office of Water Regulations and Standards, Office of Solid Waste,
Office of Toxic Substances, and the Consumer Product Safety
Commission.  This coordination will lead to resource savings for
both industry and the government by avoiding duplicative information
requests by multiple offices.
                                        25

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TSCA-Chemical     The TSCA Chemical  Substance Inventory is a list of all  chemical
Inventory
Update Rule      substances that are in commerce in the U.S.   The data originally
                 reported for the Inventory included 1977 production volume and site
                 data.   Since these data are nine years old,  their reliability is
                 diminishing.  Therefore, in FY 1986, the Agency promulgated a
                 section 8(a) rule that requires manufacturers and importers of
                 certain chemical substances included on the  Inventory to report
                 current data on production volume, plant site, and site-limited
                 status.  The information collected under this rule will  be used
                 by EPA for chemical screening, priority setting, exposure
                 determination,, as well as support, for risk assessment and develop-
                 ment of TSCA regulations.
                      This rule became effective on August 25, 1986.  During the
                 initial reporting period, August 25 through  December 23, 1986,
                 every  manufacturer or importer who produces  or imports  10,000
                 pounds or more, per year of a substance covered by this  rule must
                 report separately on every substance at each plant site.  After
                 the initial  reporting period, the same type  of reporting will be
                 required every four years, as long as the rule is in effect.  Four
                 categories of substances on the TSCA Inventory are generally
                 excluded from reporting:  polymers, inorganic substances, micro-
                 organisms and naturally occurring substances.  However,  no substance,
                 except one that is naturally occurring, is excluded from reporting
                 if the substance is:  subject to an order issued under section 5(e)
                                          26

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               of TSCA; or subject to a rule proposed or issued under section

               4, 5(a)(2), or 5(b)(4), or to a rule issued under section 6 made

               immediately effective under section 5(f); or is subject of relief

               granted under a civil action under section 5 or 7.  Small businesses,

               as defined by the rule, are exempted from reporting; even they,

               however, must report substances which are subject to an order,

               rule, or action listed above (except section 5(a)(?) SNMJRs).


Comprehensive  EPA has proposed a model information gathering rule under TSCA
Assessment
Information    section 8(a) to obtain data on the manufacture, import, and
Rule (CAIR)
               processing of chemical substances and mixtures.  This model rule-

               making, called the Comprehensive Assessment Information Rule

               (CAIR), establishes uniform reporting and recordkeeping require-

               ments along with a list of questions from which specific

               information requests <*re to he assembled on a chemical-hy-chpmical

               basis.  This rule would obtain information needed by -FPA, OSHA,

              ' NIOSH, and CPSC to support the assessment and regulation of d7

               chemical substances and mixtures.  EPA expects to add other

               chemicals to the rule in the future; thus, any chemical manufacturer,

               importer, or processor is potentially subject to it.  CAIR is

               expected.to he time- and cost-efficient both for industry and

               for the participating Federal agencies.


Chemical •      In FY 1986, EPA prepared in Chemical Hazard Information Profiles f.CHIPs)
Hazard
information    for 51 chemicals (see Appendix C).  A CHIP is a brief summary of the
Profiles
               information that is readily available concerning the health and environ-

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               mental  effects and the potential  exposure scenario of a particular
               chemical  or chemical  class.   CHIP candidates are chosen if the information
               available indicates a potential  for adverse health or environmental
               effects,  or if there is evidence  of significant production or
               exposure.  Information gathering  for a CHIP consists primarily
               of a search of secondary literature sources, including computerized
               data bases, scientific review documents,  and reference works.  In
               preparing a CHIP, EPA also solicits unpublished information from
               industry, other government agencies and various other institutions
               that are  involved in chemical risk assessment.

Substitute     Seventeen Substitute Hazard  Profi>es were prepared in FY 1986 as
Hazard
Profiles       part of the overall risk identification and evaluation process
               (see Appendix D)..  Substitute Hazard Profiles,  similar in content
               and. format, to CHIPs,  are preliminary risk identification documents'..
               If one  chemical is~ being considered for risk, management' action
               under TSCA, these profiles will  help to ensure  that an even more
               hazardous chemical is not substituted for the first one.

   Section 21  Under section 21 of TSCA, any person may  petition the EPA Adminis-
   Petitions
               trator  to initiate a proceeding  for the issuance, amendment, or
               repeal  of a rule or order under  various sections of the Act.  With-
               in 90 days of when the petition  is filed, EPA must either grant or
               deny the  petition.  If it is granted, EPA must  promptly commence
               an appropriate proceeding in accordance with section 4, 5, 6, or 8
               of TSCA.   Denials must be published in the Federal Register along
                                        28

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                with EPA's reasoning.  If EPA denies the petition or fails to act
                within 90 days, the petitioner may begin a civil  action in a U.S.
                District Court.  Five petitions were received in  FY 1986,  one of
                which was withdrawn, three of which were denied,  and one is pending.
                A petition that was submitted by the Environmental  Defense Fund
                and the National  Wildlife Federation in FY 1985,  and partially
                granted in FY 1.985, resulted in a regulatory investigation of
                dioxins and furans.  The actions taken included a proposed section
                4 test rule and a section 8(a), (c), and (d) information gathering
                rule, both published in December of 1985.
                     In FY 1986,  EPA published guidance for preparing citizens'
                petitions.  This  guidance is intended to help petitioners
                effectively present their concerns to EPA with the maximum amount
                of documentation.  Use of this guidance will help the Agency
                properly evaluate petitions within the mandated 90-day review.

Monitoring      Several chemical-specific and broad-based monitoring activities
Activities
                were undertaken in FY 1986 to support regulatory  decisionmaking
                on new and existing chemicals.
                     The National Human Monitoring Program (NHMP) monitors the
                prevalence and levels of exposure to toxic substances in the U.S.
                population.  These data are used to identify trends, assess regulatory
                efficacy and to provide environmental results measures.  In FY
                1986, emphasis was placed on increasing EPA's capability to assess
                existing chemical problems through the use of human body burden
                data.
                                        29

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     The National Human Adipose Tissue Survey (NHATS) is currently
the main program under the NHMP.  The NHATS has been expanded to
monitor additional chemical classes by means of a new analytical
protocol.  To assist in this change, a methods comparability
study is underway to compare old and new protocols.  In addition,
a special study of the unidentified chromatographic peaks from a
previous broad scan analysis has resulted in the identification
of additional compounds for assessment.
     EPA and the Veterans Administration are working on a
collaborative project to study'dioxin and furan levels in human
adipose tissue of Vietnam Veterans and matched control samples of
non-Vietnam Veterans and non-veterans.  The National Human Adipose
Tissue Survey is the source of specimens for this retrospective
study.
     EPA is participating in a cooperative study with the Ecological
and Toxicological Association of the Dyestuffs Manufacturing Industry
and the American Textile Manufacturers Institute.  The purpose of
the study is to improve EPA's assessment of exposure and associated
risk from the use of powdered dyes in the American textile industry.
During the first phase of the survey, a questionnaire was sent to
a representative sample of the industry to collect general
information.  The second phase involves the measurement of actual
exposure levels in a representative group of U.S. textile plants.
A wide variety of information is being collected characterizing
the dye/drug room operations at each site as well as the air
samples in the breathing zone of the workers.  This study is
expected to be completed in late FY 1987.

                            30

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     As part of the overall  exposure assessment for methylene



chloride and five other solvent chemicals, EPA is examining



consumer exposure by means of data from a nationwide survey of



household usage of products containing these solvent chemicals.



Consumers were asked about their frequency, extent, and patterns



of use of different household .cleaning, lubricating, painting,



and automotive products.  The data, which are currently being



analyzed, will be used to produce the consumer segment of an



overall exposure assessment for these chemicals.  As part of the



planning of the national survey, a shelf survey was conducted to



determine the incidence and levels of methylene chloride in a



variety of consumer products.



     EPA began collecting preliminary information on the presence



of chlorinated paraffins in water, sediment, biological tissue,



and associated environmental  levels. . Samples were collected in



the Sugar Creek, Dover, Ohio area.  Additional sites will be



be evaluated in FY 1987.  An ancillary effort to see if chlorinated



paraffins can be found in human adipose tissue is also being planned,



using the National Adipose Tissue Survey as a mechanism to collect



the samples.



     In support of the PMN program, a series of national surveys



was initiated to examine the frequency, duration and amount of



consumer use of certain products containing chemicals of interest



to EPA.  Two surveys examined consumer usage of household cleaning



products and painting products, two categories into which many



PMN chemicals fall.  The information from these surveys will be
                            31

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Underground
Storage
Tanks
               used to support the exposure assessment process for new chemicals

               manufactured for these types of products.


               The FPA National Survey found that a significant proportion of

               the nation's estimated 800,000 underground motor fuel  storage

               tanks may be leaking.  The National  Survey, conducted  for

               FPA's Office of Underground Storage Tanks, was" based on a national

               probability sample of 890 establishments with.?,400 tanks on thp

               premises.  A random subsa^ple of ?1& establishments was chosen

               for physical tank testinq, and at these sitps d?3 t.ank s.vstpms

               were tested for tightness.  An estimated 35 percent of fhese tank

               systems failed the FPA' tightness tost, which ppnuired  that the

               tanks and associated piping be filled above normal  operaHnn

               levels.  The information obtained in the survpy will bp n$pd by

               FPA' when developing regulations to control leaking underground

               motor fuel' storage tanks.'

RISK
EVALUATION

               Major risk evaluation activities in FY 198F focused on the

               regulatory investigation of formaldehyde and methylene chloridp.

               The Agency prepared risk assessment documents on six potentially

               hazardous chemicals.  Additionally, a major toxic air  pollution

               strategy was produced by the Agency, indicative of orowing

               attention to the problem of sudden accidental releases.


Chlorinated    In FY 1985, FPA, under section *(f) of TSCA, announced that
Solvents
               methylene chloride may present a risk of human cancer  from certain

               exposures.  Methylene chloride is a high-volume chemical  with a
                                        32

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               variety of uses, including as a solvent, aerosol . propel lant,  and

               degreaser.  In October 19R6, the Agency published an Advance  Notice

               of Proposed Rulemaking (AMPR), announcing plans to conduct a

               comprehensive interaqency regulatory investigation of exposures

               to methylene chloride.  Other Federal agencies participating

               include OSHA, CPSC, and FDA.

                    A major issue in the regulatory investigation is that other

               chlorinated solvents with similar toxicities could he used as

               substitutes for methylpne chloride.  The potential substitutes  may

               not result in significant risk reductions;  therefore, the Aoency

               is assessing the risks and benefits of alt-ernative regulatory

               apnroaches for six solvpnts (carbon tetrachloride, trichloroethylenp,

               perchloroethyl ene, trichloroe^hane, CFC-113, and  methylene chioridp).

               The use of other solvents in four use categories  (decreasing, dry

               cleaning, paint stripping and aerosols) are being evaluated.

               EPA will assess the control measures of several statutes including

               TSCA, the Clean Air Act, the Safe Prinking Water  Act, thp Clean

               Water Act, and the Resource Conservation and Recovery Act to

               determine which will be most appropriate in this  case.  PPA win

               also consider the regulations administered by other agencies,

               including OSHA, CPSC, and FDA, as well as whether non-regulatory

               options could suffice.
Risk           Six risk assessment documents were prepared in FY IQPfi.   The risk
.Assessments
               assessment on the chemical perchloroethyl ene, used as a  solvent  in

               dry cleaning and as a metal degreaser, addressed carcinogpnic

               effects and general population, worker, and consumer exposure.
                                           33

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           Perch!oroethylene is now part of the chlorinated solvents  strategy
           described above.  The risk  assessment on 3-chloro-2-methylpronene,
           an intermediate, addressed  carcinogenic effects  and  exposure  from
           manufacturing and emissions.   This document  was  prepared  for  the
           State of Maryland.  The risk  assessment on l,4-dichloro-?-hutene,
           also an intermediate, addressed workplace exposure and  carcinogenic
           effects.  The document was  prepared for OSHA,  NIOSH,  and  the
           manufacturers of l,4-dichloro-2-hutene.  A risk  assessment on
           acrylamide, an intermediate in polyacrylamide  manufacture, addressed
           carcinogenic and systemic toxicity as well as  mutagenicity.
           Exposures to manufacturing  workers and workers doina sewer line
           grouting are expected.  The risk assessment  on paradichlorohenzene,
           us^d as a deodorizer and moth repellant, addressed carcinogenic
           risk to consumers.  A final risk assessment  addressed formaldehyde,
           used in wood products, and  in-moMle and conventional homes  huilt
           w-ith. urea-formaldehyde.

Pesticide  EPA developed a proposed strategy for reaulating the toxic and
Inerts
Project    potentially toxic inert ingredients that are used in pesticide
           products, in order to minimize public health and environmental
           risks.   Of the 1?00 substances identified as inerts,  most  have
           been tested only for acute  toxicity, hut not for their  potential
           chronic effects such as cancer and hirth defects.
                The 1200 inerts have been divided into  four different
           categories:  toxic inerts (List 1 - known human  and environmental
           effects); potentially toxic inerts (List ?.)• inerts of  unknown
           toxicity (List 3); and inerts of minimal hazard  (List 4).
                                    34

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                The Office of Pesticide Programs (OPP) is reviewing the 55

           substances on List 1 in order to assess the extent of exposures

           and risks each poses and subsequently to determine what, if

           any, regulatory action is warranted.

                The Office of Toxic Substances (OTS) is responsible for

           managing the review of approximately  60 inert substances on List

           2 which have high priority for testing.  This involves gathering

           any relevant data in the published literature, data developed

           under EPA and other governmental testing programs, and data submitted

           to EPA under TSCA section 8.  OTS will  work with OPP to identify

           significant data gaps and to determine which mechanism under

           FIFRA or TSCA is most.appropriate to  obtain the necessary toxicity

           data.  EPA will then use these test data to determine if an inert

           should be placed on List 1 for further action or on List 4 because

           of minimal hazard.

Chemical   In December 1985, EPA announced the development, of a voluntary
Emergency
Prepared-  program to address accidental releases of chemicals that could be
ness
Program    acutely hazardous.  The Chemical Emergency Preparedness Program

           (CEPP) was designed both to increase  community awareness of

           potential hazards and to stimulate the development of State and

           local emergency plans for responding  to chemical accidents.  CEPP

           produced a guidance document which included an introduction to

           the program, sections on developing community emergency contingency

           plans, gathering and analyzing site specific information, contingency

           planning appraisal, and criteria to identify acutely toxic chemicals.

           An interim list of 402 acutely toxic  substances that have the
                                       35

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          potential  to create an emergency situation accompanied the document,
          plus information profiles on these substances.   The guidance
          includes a procedure to determine the minimum quantities of concern
          for these chemicals.

Chemical  EPA is evaluating the potential  application of categorical approaches
Category
Evalua-   for risk assessment of several  groups of chemicals.  This evaluation
tion
          includes a review of the health or environmental concerns, 'exposure,
          and economic aspects of these categories.   The categories under
          review were selected based on the experience of both the new and
          existing chemical programs.  The main criteria for their selection
          for this review were concerns about the toxicities of several
          of their constituent members and high levels of current activity
          in the new or existing chemical  programs.   A decision is expected
          in early FY 1987 on whether any of these categories, should enter a
          more detailed analysis to determine the-need for regulatory activity.
 RISK
 MANAGEMENT
          Risk management activities in FY 1986 resulted in TSCA section
          6 actions or section 9 referrals on polychlorinated biphenyls,
          asbestos, 1,3-butadiene, glycol ethers, formaldehyde, MBOCA,
          toluenediamine and chloromethane.  The Agency also developed
          section 5 significant new use rules (SNURs) to monitor new uses
          of substances on the TSCA Chemical Substances Inventory, including
          PBBs, Tris, methyl £-butyl ketone (MBK), hexachloronorbornadiene
          (Hex-BCH), hexamethyl phosphoramide (HMPA), urethane, 11-amino-
                                      36

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         undecanoic acid (11-AA1, and pentachloroethane.   Descriptions  of

         some siqnificant FY 1986 activities are presented below.
Polychlorinated
Biphenyls
         In FY 1986, EPA made substantial  progress in developino

         a nationwide policy for the cleanup of spilled PCPs.   This

         policy is being developed to establish consistent nationwide

         standards for the cleanup of PC3s in soil  and on  surfaces  such  as

         concrete and asphalt.   The Agency hopes that by publishing  its

         standards for cleanup,  industry will  move quickly tn  conduct

         thorounh cleanups with  minimal  oversiaht by FPA.   The existing

         process involves consultation with the Regional  offices prior

         to cleanup and has led  to protracted cleanups in  some cases.

              In FY 1°86, EPA continued  to implement the TSCA  section *(e)

         prohibitions on polychlorinated biphenyls fPCRs)  by is^m'na a

         final  rule in August 1986 that  ^responded-to ??. petitions for

         exemption from the prohibition  against, manufacture, processinq,

         and distribution in commerce of PCRs; 16 were granted,  ? were

         denied, 1 was granted  in part and denied in part, and ? were

         dismissed.  TSCA provides that  EPA may grant exemptions

         if (1) the Administrator finds  that there would be no unreasonable

         risk to health or the  environment, and (?.} good faith efforts have

         been made to develop a  chemical which does not present  an  unreasonable

         risk,  and which may he  substituted for PCR.

              In April 1986, EPA published "PCR Transformers and the Pisk  of

         Fire:  A Guide for Ruilding Owners," an information leaflet  designed
                                     37

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to improve compliance with the final  PCB Transformer Fires Rule



published in FY 1985.  EPA continues  to promote industry participation



in the development of PCB destruction methods with the objective



of attaining safe handling of these toxic chemicals.  Accomplishments



in FY 1986 include the issuance of 10 research and development



(R&D) permits, 9 demonstration permits, and 5 nationwide disposal



permits (see Table 3).





                           Table 3



          Actions on Nationwide PCS Disposal  Permits



                           FY 1986





                    Applications Received:  18



                       R&D Permits Issued:  10



                Permit Deficiency Letters:  16.



             Demonstration Permits Issued:   9



          Nationwide Final Permits Issued:   5
                            38

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 TSCA     The TSCA Ground-Water Protection Strategy focuses on sources of
 Ground-
 Water    ground-water contamination that are not presently being emphasized
 Pro-
 tection  by other Agency programs.  In FY 1986, the TSCA Strategy
 Strategy
          concentrated on collecting information on the following potential

          sources of ground-water contamination:  septic tank systems;

          agricultural chemicals outside the jurisdiction of FIFRA; fertilizers

          used on lawns, gardens, and shrubbery; and volatile organic.chemicals

          released through leaks, spills, and dumping, especially by small

          industries and commercial establishments.  The Agency will use

          this information to develop strategies for preventing or mitigating

          ground-water contamination from these sources.


Quality   The Office of Toxic Substances Quality Assurance (QA) program is a
Assur-
ance      dynamic and integral part of all intramural and. extramural projects

          requiring environmentally related measurements.  A major strength

          of the QA program is the commitment and awareness that management,

          at all levels within the program office, has with respect to

          quality assurance.  Through this commitment, and in concert with

          a program which is practiced on a day-to-day basis, the OTS Quality

          Assurance Program Plan was approved by the Agency's Quality Assurance

          Management Staff.  The OTS was one of the first program offices to

          receive this approval.


Asbestos  On April 25, 1986, EPA issued a final rule under TSCA to protect

          State and local government employees from the potential hazards of
                                      39

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asbestos abatement work.  This rule effectively extends Occupational
Safety and Health Administration (OSHA) worker-protection require-
ments for asbestos abatement to State and local employees who
perform asbestos abatement work.
     OSHA is normally responsible for the Federal  regulations
protecting workers, but the Occupational Safety and Health Act
does not give it authority to cover State and local government
employees.  However, 23 States and territories have set standards
for State, and local employees that are at least as strict as
OSHA's worker-protection rules.  In addition, EPA decided that
four other States,. Idaho,. Kansas,. Oklahoma- and Wisconsin, have.
regulations that-are comparable to or more stringent than its rule..
The EPA final regulation thus applies to the remaining 23 States only.
     The EPA regulation is similar to.; the. exist-ing OSHA. standard'-in
both the exposure 1imits it establishes and the maximum concentration
it allows at any one time.  It also requires work practices such as
wetting of asbestos, use of personal protective equipment and provision
of special clothing.  Furthermore, it requires environmental monitoring,
the posting of caution signs, cleanup, and proper disposal of'asbestos
waste, as well as medical examinations for certain employees and the
retention of medical examination and environmental monitoring records.
However, the EPA rule does not cover routine repair of less than three
linear or three square feet of friable asbestos material.  Thus, minor
routine repairs of pipe insulation by sealing or taping would be
exempt.
                                40

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     In January 1986, EPA proposed a rule under section 6 of TSCA
to ban the manufacture, import and processing of certain asbestos
products.  The Agency also proposed to phase out asbestos use in
other products, and to require labeling of any product that
contains asbestos and is not banned.  Labeling would ensure that
persons working with the products would know they contain asbestos,
and enable them to reduce the likelihood of exposure.
     Under section 6, EPA proposed to prohibit five asbestos products:
roofing felts, flooring felts, vinyl-asbestos floor tile, asbestos
cement pipe and fittings, and asbestos clothing.  In addition,  all
remaining domestic mining and importation of asbestos  would be
phased out over a 10-year period.  The 10-year phase out that
affects other products would be accomplished via a transferable
permit system, under which EPA would allocate permission to mine
or import, a specific volume of asbestos per year.
     EPA is considering additional approaches to address the
risks associated with asbestos products, including the ban of
categories of asbestos products, such as asbestos construction
products and .asbestos friction products, at staged intervals.
     In encouraging the development of substitutes, EPA is
promoting a significant reduction in risk.  The products that
are currently replacing asbestos appear to present lower risk.
However, EPA will monitor the development of substitutes, and
will use TSCA to require that the substitutes be tested, if that
measure seems necessary to ensure their safety.
     In August 1986, EPA published an advance notice of proposed
                            41

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rulemaking soliciting comments on the future direction of its
program to reduce risks from asbestos in schools.  EPA currently
uses guidance and technical assistance, with limited Federal
regulation, to motivate schools to abate asbestos risks.  EPA is
considering whether to continue with the status quo or to
implement its current approach more aggressively or to selectively
incorporate a greater emphasis on Federal regulation.  After
review of these comments, EPA may propose further regulatory
requirements under section 6(a) of TSCA.  In FY 1987, EPA expects
either to propose additional Federal regulations or publish reasons
why it believes additional regulations are not. necessary..
     The study, "Evaluation of Asbestos Abatement Techniques;
Phase I: Removal", completed in FY 1986, concluded that it is
possible both to remove asbestos-containing material from a school,
and to achieve 'low'airborne levels after that- removal, by means of
post-reTnoval cleanup.,  EPA selected four schools in-one suburban
school district for the study because the district was already
committed to an asbestos removal program.  The study also concluded
that transmission electron microscopy (TEM) provides the clearest
documentation of changes in airborne asbestos levels.  Two other
analytical methods in addition to TEM, scanning electron microscopy
and phase contract microscopy, were studied.
     The study, "Evaluation of Asbestos Abatement Techniques;
Phase II:  Encapsulation With Latex Paint," was published in FY
1986.  The study concluded that high airborne asbestos levels can
occur within the work site during encapsulation and that airborne
                            42

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 asbestos  levels  can  be  significantly reduced after encapsulation
 of  asbestos material, although it is impossible to predict how
 long  this  reduction  will  last.  Because airborne asbestos levels
 can be  high within the  work area during encapsulation, containment
 barriers  should  always  be used to prevent contamination of the
 rest  of the building, and workers involved in the project should'
 wear  respirators  for protection while  in the containment area.
 Air samples for  this field study were  collected at a variety
 of  sites  in a  suburban  school undergoing encapsulation with latex
 paint.  The samples  were  analyzed with Transmission Electron
 Microscopy.
      In the "Asbestos Abatement Efficacy Study—Phase III", air
 level samples  were monitored  in schools with students present to
 determine  the  effectiveness of the asbestos removal that had taken
.place-during the  previous summer.  Sampling was completed in
 November  1985; results  will be published in FY 1987;
      EPA  completed a random sampling scheme for friable surfacing
 materials  in buildings.   The  scheme is contained in the document,
 "Asbestos  in Buildings:   Simplified Sampling Scheme for Friable
 Surfacing  Materials." Pertinent statistical support is detailed
 in  the  document,  "Statistical Support  for Asbestos in Buildings:
 Simplified Sampling  Scheme for Friable Surfacing Materials."
      EPA  also  finalized "Measuring Airborne Asbestos Following an
 Abatement  Action."   This  guidance document discusses methods for
 determining when  an  asbestos  abatement project has been completed
                            43

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            satisfactorily, a process which involves both air monitoring and
            sample analyses.

ASHAA       Effective in FY 1986, Congress included tough new restrictions
Asbestos
Activities  for Federally-funded asbestos work in schools.  Now all  on-site
            supervisors and a majority of the hired asbestos abatement workers
            must either be State-certified or have attended EPA-approved
            asbestos abatement training courses.
                 With these restrictions in place, Congress appropriated $50
            million in FY 1986 under the Asbestos School  Hazard Abatement Act
            (ASHAA) to aid those primary and secondary schools with  a severe
            asbestos hazard who cannot afford to  abate the hazard on their own.
            EPA- awarded $47'million in grants and loans to 173 of the Nation's
            neediest public and private school districts, to help perform 421
            asbestos abatement projects in 295" schools..  All of the-1,777
            schools that applied. for ASHAA funds  in 1986  were- ranked on a
            national scale, based on the extent of the health hazard the friable
            asbestos posed to students and employees.   EPA decided how much
            money each school district was to receive  on  the basis of that
            ranking.  Each school authority then  decides  on the most effective
            remedy:  removal, encapsulation or enclosure  of the asbestos.  Most
            of the EPA-supported schools chose asbestos removal.  The legislation
            has authorized EPA to spend $600 million over seven years to abate
            asbestos in qualifying schools.
                 Fourteen States already have certified programs for
            contractors; within a year an additional  nine States should have
                                        44

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qualified certification programs.  Meanwhile, EPA is funding the
National Association of Minority Contractors to conduct training
in New York City, Detroit, and Los Angeles.  These courses will
be EPA-approved, and will  meet the congressional  requirement.
     In 1986, EPA approved a number of asbestos abatement
training courses for supervisors and workers.  EPA-funded training
facilities are located in  (Georgia Tech) Atlanta, (University of
Kansas) Kansas City, (Tufts) Boston, (the University of Illinois)
Chicago, (the University of Texas) Arlington, TX, (the University
of Utah) Salt Lake City, (Drexel University) Philadelphia, and
(Rutgers University) Piscataway, NJ.  The University of California
at Berkeley is funded by EPA to offer EPA-approved courses.  EPA
expects to begin approving other courses for the ASHAA program
within the next few months.  The National Asbestos Council (NAC)
and the Committees on Occupational: Safety and Health also have
received EPA approval and  are receiving Agency funds to conduct
abatement worker training  courses.  These programs are designed
for nonsupervisory workers in the abatement industry.  NAC can
send field personnel to a  particular project location for on-site
training.
     Under the ASHAA program for contractors in States without
training requirements, a training course that has been approved  by
any State certification and training program is an EPA-approved
course.  For example, the  Association of Wall and Ceiling Industries
(AWCI) training course is  approved by Alabama.  As a result, the
AWCI course is acceptable  not only in Alabama, but also in any
                            45

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         other State that has no certification  and training programs.

Referrals
         In FY 1986, the EPA Administrator signed separate agreements  with
         the heads of two other Federal  agencies  to enhance interagency
         control  of toxic substances.   These agreements  coordinate and
         streamline the way TSCA section 9(a)  actions  are handled  by  EPA,
         the Occupational Safety and Health Administration (OSHA)  and  the
         Consumer Product Safety Commission (CPSC).
              The intent of the two memoranda  of  understanding  is  to  promote
         more efficient EPA administration of  TSCA section 9(a)  actions,  in
         order to better conform with  the responsibilities of OSHA and
         CPSC.  EPA, OSHA and CPSC have different, though related,
         responsibilities and objectives with  regard to.toxic substance
         control.  In order to regulate a toxic substance under TSCA,  EPA
         must make a finding of unreasonable risk -of injury to  health  or
         the environment.  The Occupational Safety and Health Act, enacted
         in 1970, requires OSHA to demonstrate  that there is a  significant
         risk to employees from a substance in  the workplace, in order
         to regulate it.  CPSC administers three  laws  that could be used
         in certain circumstances to address those risks that EPA  would
         otherwise process under TSCA.   These  acts are the Consumer Product
         Safety Act, the Federal Hazardous Substances  Act and the  Poison
         Prevention Packaging Act.
         1,3-Butadiene
         In October 1985, EPA referred  1,3-butadiene to  OSHA for regulatory
                                     46

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consideration.  EPA presented its conclusion that the manufacture
of 1,3-butadiene and its processing into polymers presents an
unreasonable risk of cancer to workers.  EPA has determined that
this risk may be prevented or reduced to a sufficient extent if
action is taken under the Occupational  Safety and Health Act.
Glycol Ethers
In FY 1984, EPA initiated a regulatory investigation under TSCA to
explore the^need for reducing worker exposure to two glycol ethers,
2-ethoxyethanol and 2-methoxyethanol, and their acetates.  Studies
indicated that glycol ethers produced adverse reproductive and
developmental effects in animals at low doses.
     The Agency determined that a workplace standard of the same
type as the current OSHA standard can sufficiently reduce risk for
workplace settings where glycol ethers are used, manufactured,
formulated or processed.  In May 1986, EPA -referred the class- of
glycol ethers to CPSC under the authority of TSCA section 9(a),
Toluenediamine
In July 1986, EPA announced termination of its investigation of work-
place exposure to toluenediamine (TDA).  In accordance with TSCA
section 9(d) EPA transmitted to OSHA its public record pertaining
to this issue.  EPA made this decision because the chemical's
potential risks in the workplace are properly a matter of concern
for OSHA.  Subsequently, EPA issued a Chemical Advisory to inform
manufacturers who use TDA that it is a probable human carcinogen.
The Chemical Advisory also suggests ways to reduce worker exposure.
EPA will continue to investigate the environmental hazards posed
                            47

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by IDA in non-occupational settings.
4,4'-Methylene Bis(2-ch1oroani1ine) (MBOCA)
In June 1986, EPA announced termination of its regulatory investi-
gation of MBOCA, which had begun in May 1983.  EPA transferred its
public file on the chemical to OSHA, in accordance with section
9(d) of TSCA.  OSHA has statutory authority to prevent, or reduce
to a significant extent, the risks associated with the processing
and use of MBOCA in the workplace.  OSHA has been kept informed of
EPA activities during the latter's regulatory investigation of
this chemical.  EPA had previously issued a Chemical  Advisory to
all MBOCA processors-in tha United. States.,  The-Agency also issued
a TSCA section 8 reporting and recordkeeping rule which requires
persons to notify EPA if they currently are manufacturing MBOCA in
this country,, or if they begin-manufacturing the-substance or
alter their method of manufacture-.in the future..  The rule excludes
importers from its reporting requirements.  It enables EPA to
evaluate activities which may result in exposure to MBOCA, and to
take followup regulatory action, if necessary, to reduce risk to
human health or the environment.
Formaldehyde
In May 1984, EPA determined under section 4(f) of TSCA that exposure
to formaldehyde may pose significant risk of widespread harm to the
large number of persons who either live in mobile and conventional
homes made with urea-formaldehyde wood products, or who manufacture
apparel from fabric treated with formaldehyde-based,  durable-press
resins.
                            48

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              In March 1986, EPA published a notice announcing that the Agency

         was ending its investigation of the risk posed by formaldehyde exposure

         in the workplace, including the risk to manufacture apparel  workers,

         and was sending the information it had developed to OSHA.   Uith respect

         to the risks posed by exposures in mobile and conventional homes,  a

         risk assessment document was prepared in FY 1986; regulatory options

         will be considered early in FY 1987.

         Chloromethane

         In May 1986, EPA referred chloromethane to OSHA, under TSCA section

         9(d), for consideration of potential carcinogenic and systemic toxicity

         risks at the current OSHA Permissible Exposure Limit (PEL).


Signifi- Once a final SNUR (TSCA section 5{a)(2)) for a substance is issued,
cant
New Use  a person who intends to manufacture, import or'proeess the
Rules                                      ...
        • substance for a significant new use is required to. notify  EPA at

         least 90 days before beginning such activity.  A substance listed

         in a SNUR is generally subject to the same statutory procedures as

         those required under TSCA's PMN rule for a new chemical  substance.

         The purpose of the SNUR notice requirement is to furnish EPA with  the

         opportunity to evaluate the intended use of the substance  and, if

         necessary, give the Agency enough time to prohibit or limit the

         use before its inception.

         PBBs and Tris

         EPA proposed a SNUR for eight polybrominated biphenyls (PBBs)

         and for tris 2,3-dibromopropyl phosphate, also known as  Tris.
                                       49

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In this proposed rule, EPA indicated that any use or related
activities involving PBRs or Tris may result  in significant
human or environmental exposures.  Even though these substances
are listed on the TSCA Inventory, EPA is not  aware of any use of
them in the United States since at least 1980.  In 1977,  EPA
began to investigate the need to control PRRs and Tris under
TSCA.  In 1980, EPA issued a TSCA section fl(a) rulp reguiring
submission of a Notice of Manufacture or Importation for  PB^s
and Tris.  That rule included a "sunset provision" that terminated
the reporting requirements for those chemicals by May 1,  19RB.
Since then, EPA has reassessed the toxicity of PRRs and Tris, past
and present exposure, and the need for further information about
these chemicals.  The Agency decided a SNUR would provide the
information.
1,2,3,4,7,7-Hexachloronorbornadi pne
In November 1985, EPA issued a final rule reguiring certain
manufacturers, importers, and processors of 1,?,3,4,7,7-hexachlorn-
norbornadiene (Hex-RCH) to submit a section 8(aj report;  and  other
manufacturers, importers, and processors of Hex-BCH to submit a
significant new use notice under section 5(a)(2).  The reports
and notices will allow EPA to monitor the volume of Hex-RCH
manufactured, imported, and processed; the number of individuals
exposed; the manner of environmental release; and the method  of
disposal.  EPA will evaluate the reported information to  determine
if further regulatory action is appropriate.
                            50

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11-Aminoundecanoic Acid
In July 1986, EPA. proposed a SNUR to require manufacturers,
importers, and processors of 11-aminoundecanoic acid (11-AA)  to
submit a significant new use notice for any use except as  an
intermediate in the manufacture of nylon 11 in an enclosed process.
At the same time, EPA also proposed, under TSCA section 8(a),
that manufacturers, importers, and processors of 11-AA who are
not covered by the SNUR notification requirements notify EPA  of
prospective manufacture, import, or processing of this substance.
Both requirements would provide EPA with the -information needed
to determine if further regulatory action is warranted to  control
exposure.
HMPA and Uretnane
EPA issued a final SNUR for two substances, hexamethylphosphoramide
(HMPA) and urethane, because they are expected to be hazardous
to health, and their use may result in significant human and
environmental exposures.  Both substances are known animal
carcinogens and suspected human carcinogens.  Neither substance
has been imported into the United States, nor manufactured
nor processed here, for some time.  The SNUR requires that any
person who intends to manufacture, import or process either
substance for any use must submit a significant new use notice to
EPA.
Pentachloroethane
EPA proposed and promulgated a SNUR to require persons to notify
                           51

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              the Agpncy at least 90 days before beginning the manufacture,

              import, or processing of pentachl.oroethane for any use.  At one

              time, pentachloroethane was used as an intermediate in the production

              of tetrachloroethylene.  The Agency believes that initiation of a

              significant new use of pentachloroethane could result in significant

              human exposure.  The rule will furnish FPA with information needed

              to evaluate an intended use, and allow the Agency to take steps to

              protect against potentially adverse exposures to this substance

              before such exposures can occur.
                      ^
              Methyl n-Rut.yl Ketone (MRK)

              In July 19Sfi, FPA proposed a SNUR for methyl n-butyl ketone- (MRK).,

              EPA believes M5K can cause neurotoxic effects in humans, and any

              use of it may result in significant human exposure.  The substance

              has been* used as' a solvent" for lacquers and in lacquer and varnish

              removers..  MRK also.has been used as a sol vent. for-'Oi Is,..fat's1 and

              waxes'.  In 1979, the1 only known- MBK manufacturer in the- United

              States discontinued production of the substance and sold the last

              of its inventory in 1981.  MRK is not now being imported into the

              United States.

Chemical      EPA uses Chemical Advisories to inform individuals or organizations
Advisories
              about toxic effects of certain chemicals, exposures which are of

              concern, and alternative methods of reducing risks.  They are

              developed after consultation with interested parties, including

              companies, public interest groups, and other agencies.  Chemical

              Advisories are designed to he used where increased awareness of

-------
potential risk is likely to lead to meaningful  precautions, and
are addressed and.distributed to individuals or organizations for
whom the information is most useful.  They are intended to encourage
voluntary risk reduction actions by individuals or organizations
in instances where regulatory control  is not appropriate, or as
interim measures while regulatory action is pursued.
     In FY 1986, two Chemical Advisories were issued, addressing
hazards from burning used motor oil and 2,4-toluenediamine.  The
Chemical Advisory on burning used motor oil addresses the problem
of potential exposure to lead and other combustion products from
improperly vented space heaters.  Small workplaces, such as garages
and service stations, often heat by burning used oil drained from
gasoline-powered engines.  This oil contains lead that has been
deposited in the engine as a by-product of fuel combustion.  When
the used oil is burned in undented heaters', lead in the exhaust
gases enters the workplace air.  Excessive lead levels in inhaled
air can cause toxic effects in humans, including nerve and irreversible
brain damage, kidney failure, anemia,  high blood pressure, various
blood and metabolic disorders and gastrointestinal disturbances.
Lead particles may also be deposited on workplace surfaces.  These
particles can be ingested inadvertently, increasing the total
exposure.  The Advisory was distributed in November 1985 to com-
plement a proposed rule by the Office of Solid Waste, under the
Resource Conservation and Recovery Act (RCRA).   As proposed, that
rule would ban burning used oil in unvented space heaters.
                            53

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     The second Chemical Advisory, completed in September 1986,
advises .manufacturers of products that contain 2,4-toluenediamine
to minimize worker exposure to these products.  2,4-Toluenediamine
causes cancer in laboratory animals and is considered by EPA to be
a probable human carcinogen.  This Advisory also suggests ways to
reduce exposure.  Workers may be exposed to TDA by inhalation or
.ingestion of vapors or particles, and by skin contact.  TDA is
shipped and handled in either molten or solid state.  When molten
TDA is handled, any vapors which escape into workplace air may
condense into fine particles and be deposited on clothing or on
work surfaces,, making them available-for absorption through the
skin.  TDAs in the solid state have low vapor pressure and do not
normal'ly present an inhalation hazard.
                         54

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5.  CHEMICAL TESTING PROGRAM
Program  Data obtained through testing are used by EPA and others  to determine
Status
         whether and how to regulate or control potentially hazardous chemicals.

         Section 4 of TSCA gives EPA the authority to require manufacturers  or

         processors of chemicals to test for certain health or environmental

         effects.

              A test rule specifies the chemical  to be tested, health and

         environmental effects for which testing  is required, test standards,

         schedules for submission of data, and who is responsible  for

         conducting the testing.  To require testing EPA must find that  a

         chemical may present an unreasonable risk, that there are insufficient

         data available with which to reasonably  determine or predict the

         effects of the chemical, and that testing is necessary to generate

         such data.  A test rule may also be based on an EPA finding of

         substantial  production and exposure to humans and the environment.

              In June 1986, EPA issued an Interim Final  Rule  that amended

         the existing regulations for the development-and implementation of

         testing requirements under section 4 of  TSCA.  The amendment

         establishes procedures for using enforceable consent agreements to

         require testing under section 4.  This rule will allow EPA to

         negotiate with manufacturers, processors, and other interested

         parties to establish testing programs that satisfy EPA testing

         needs.  An enforceable consent agreement may be adopted in a case

         where consensus on an industry test program is reached in a timely

         manner by EPA, affected manufacturers, processors, and other

         interested parties.  If timely consensus cannot be reached or
                                     55

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appears unlikely, EPA will invoke the pertinent rulemaking procedure,
as specified in the Act.  The Agency believes the consent agreement
process will lead to the development of necessary test data
significantly earlier than formal rulemaking.
     The Interagency Testing Committee (ITC) continues to designate
chemicals to EPA for priority testing.  The ITC is comprised of
appointed members from eight Federal agencies, as specified in
TSCA.  Representatives from six additional  Federal agencies serve
in a liaison capacity.  EPA must respond to chemical  designations
within twelve months either by initiating rulemaking or by giving
reasons for not so doing.  The ITC may designate up to 50 chemicals
or categories of chemicals for testing; it  must consider revising
its' list, and report to EPA at least every  six months.
     To date, the use of section 4 authority to obtain data
through testing has been primarily in response to ITC-designated
and recommended chemicals; however, two new. uses of this' authority
were introduced in FY 1986.  First, EPA developed a test rule in
response to a citizens' petition filed under section 21 of TSCA.
The proposed test rule would require manufacturers and importers
of fourteen commercial organic chemicals to test these substances
for the presence of chlorinated and brominated dioxins.  EPA will
ultimately issue a decision that indicates  either that no further
action is warranted, or that regulatory action is warranted in the
form of controls to limit the amount of these materials manufactured
and released.  Second, EPA developed a test rule in support of
priority data development activities of another Agency program,
                            56

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                 the Office of Air Quality Planning and Standards.   In 1985,

                 1,1-dichloroethylene was considered for regulation as a potentially

                 toxic air pollutant under the Clean Air Act,  but available

                 information was insufficient at that time to  support a decision to

                 regulate.  The Agency proposes to obtain the  data  needed to  better

                 assess the chemical's oncogenic potential via section 4.


Test Rule        In FY 1986, EPA took a total of 38 ITC-related actions.
Development
                 Of these, 12 were responses to new ITC designations, and 26

                 were post-initial response determinations.  These  produced 13

                 proposed rules, 9 final  rules, 10 proposed test standards,

                 and 6 decisions not to test.  Other testing actions produced an

                 additional 4 proposed rules.  Table. 4 presents a summary of  all

                 testing actions taken in FY 1986.
                                         57

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Date
                          Table 4
            Summary of Chemical  Testing Actions

  Testing in Response to the Interagency Testing Committee (ITC)

 Chemical                      Action                         ITC List
08/26/85   2-Chloro-l,3-butadiene
           (Chloroprene)
10/18/85    4-Chlorobenzotri f1uoride
10/30/85
Octamethylcyclo-
tetrasiloxane
1.1/06/85    Cumene
11/06/85   Mercaptobenzothiazole
Decision Not. to Test;              15
available data are sufficient;
EPA is not requiring environ-
mental effects or chemical
fate testing at this time.

Decision Not to Test; data          9
available to the Agency,
including data received
pursuant to a negotiated
testing agreement, are
adequate for health,
environmental, and chemical
fate effects; no further
testing is required.

Notice of Proposed Rulemaking;     15
proposes that manufacturers and
processors conduct chemical fa.te
and. environmental effects tests;

Notice of Proposed Rulemaking;     15
proposes that manufacturers and
processors perform testing for
pharmacokinetics, subchronic
toxicity, oncogenicity,
mutagenicity, neurotoxicity,
developmental toxicity and
reproductive toxicity; if
triggered, acute and chronic
aquatic toxicity in saltwater
and freshwater fish and
invertebrates, and biodegrada-
tion and volatilization from
water.

Notice of Proposed Rulemaking; to   15
perform chemical fate and environ-
mental effects testing including
persistence and mobility, chronic
aquatic toxicity, pharmaco-
kinetics, developmental toxicity,
reproductive toxicity, neuro-
toxicity and chromosomal
aberrations.
                                        58

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11/06/85  Anthraquinone
11/06/85   Sodium N-Methyl-N-
           Oleyltaurine
11/06/85   Fluoroalkenes
11/13/85   Pentabromoethylbenzene
U/27-/85   Propylene Oxide
11/27/85   Propylene Oxide
12/19/85   1,1,1-Trichloroethane
12/20/85   Mesityl  Oxide
12/20/85   Mesityl  Oxide
                                        59
Notice of Proposed Rulemaking; to   15
perform testing for water
solubility, bioconcentration
and acute toxicity to aquatic
organisms.  Testing for bio-
degradation and chronic toxicity
of aquatic organisms, will be
required if the acute toxicity
or bioconcentration test results
and the annual production and
importatioQ level meet specified
criteria.

Decision Not to Test; existing      15
information on health effects
does not suggest potential  for
an unreasonable risk at expected
exposure levels.

Notice of Proposed Rulemaking;       7
to perform health effects
testing of vinylidene fluoride,
vinyl  fluoride, hexafluoropropene,
and tetrafluoroethane.

Notice of Proposed Rulemaking;      1R
to perform testing for chemical
fate and environmental effects.

Notice of Proposed Rulemaking-       1
Test Standards; proposes TSCA
test guidelines for develop-
mental toxicity be used as test
standard for the required study
and that test data be submitted
within a specified time frame.

Notice of Final Rulemaking;          1
requires developmental toxicity
testing.

Notice of Final Rulemaking;          3
promulgates testing in accordance
with proposed test standards and
reporting requirements.

Notice of Proposed Rulemaking-       4
Test Standards; proposes that
certain TSCA test guidelines be
used as test standards for the
required studies and that test
data be submitted within specified
time frames.

Notice of Final Rulemaking;          4
requires testing for chronic effects,
mutagenicity, and oncogenicity if
triggered from mutagenicity test
results.

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12/30/85   Hydroquinone
12/30/85   Hydroquinone
12/30/85   Quinone
01/06/86   Phenylenediamines
           (o-f m-, p-)
02/27/86   Formamide
03/27/86   Ethyltoluenes
03/27/86   Trimethyl benzene
Notice of Proposed Rulemaking-       5
Test Standards; proposes that
certain TSCA test guidelines and
industry-submitted guidelines be
used as the test standards for the
required studies and that test
data be submitted within specified
time frames.

Notice of Final Rulemaking;          5
requires testing for reproductive,
teratogenic and nervous system
effects and that the chemical's
toxicokinetics be evaluated.

Decision Not to Test; data           5
received in response to the
proposed rule indicate human
and environmental exposure to
quinone are so low as to be
unlikely to present an unreason-
able- risk to-humans or the
environment.

Notice of Proposed Rulemaking;       6
proposes testing of 0-, m-, p-POA
for their chemical fate and
environmental  toxicity and. m-PDA
for mutagenic effects and oncogenic.
effects if triggered by
mutagenicity test results.

Decision Not to Test; data          10
available, includi-ng data received
pursuant to a negotiated testing
agreement, are adequate to character-
ize formamide for health effects;
no further testing is required at this
time.  EPA may propose rulemaking to
monitor any significant change in
exposure to the chemical.
Notice of Proposed Rulemaking-
Test Standards; proposes that
protocols submitted by the
American Petroleum Institute, with
minor additions as proposed by
EPA, be adopted as test standards;
establishes schedules for the
testing.
                                    10
                                    10
Notice of Proposed Rulemaking-
Test Standards; proposes that
protocols submitted by thfe
American Petroleum. Institute, with
minor additions as proposed by
EPA, be adopted as test standards;
establishes schedules for the testing.
                                         60

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04/07/86   Chlorinated Benzenes
           (Environmental)
04/07/86   Chlorinated Benzenes
           (Environmental)
04/10/86   Diethylenetriamine
04/28/86   Cresols
04/28/86   Cresols
05/15/86  'Methylcyclopentane
05/15/86   Tetrabromobisphenol A
05/15/86   Triethylene Glycol
           Monomethyl Ether
05/15/86   Triethylene Glycol
           Monoethyl Ether
Notice of Proposed Rulemaking-      1,3
Test Standards; proposes that
certain TSCA test guidelines be
used as the test standards for
the required studies and specifies
time frames for test submissions.

Notice of Final Rulemaking;         1,3
promulgates EPA's decision to
require environmental effects
and chemical fate testing.

Notice of Proposed Rulemaking-       8
Test Standards; proposes the
adoption of study plans and
schedules fate testing.

Notice of Proposed Rulemaking-       1
Test Standards; proposes that
certain TSCA test guidelines be
used as the test standards for the
required studies and specifies
time frames for test submissions.

Notice of Final Rulemaking;          1
requires mutagenic effects,
developmental t-oxicity, and
reproductive .effects testing/
studies.

Notice of Proposed Rulemaking;      16
to perform testing for neuro-
toxicity, subchronic toxicity,
and inhalation and dermal
pharmacokinetics.

Notice of Proposed Rulemaking;      16
to perform testing for chemical
fate and environmental effects.

Notice of Proposed Rulemaking;      16
to perform subchronic toxicity,
developmental toxicity, neuro-
toxicity, mutagenicity, repro-
ductive toxicity, and onco-
genicity testing.

Notice of Proposed Rulemaking;      16
to perform subchronic toxicity,
developmental toxicity, neuro-
toxicity, mutagenicity, repro-
ductive toxicity, and onco-
genicity testing.
                                         61

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05/15/86
Triethylene Glycol
Monobutyl Ether
07/08/86
Chlorinated Benzenes
(Health)
07/10/86   Biphenyl
U/
           i eurdi.ii i uruueruene
08/04/86
2-(2-Butoxyethoxy)-
ethyl acetate
09/09/86   1,2-Dichloropropane
Notice of Proposed Rulemaking;      16
to perform subchronic toxicity,
developmental toxicity, neuro-
toxicity, mutagenicity, repro-
ductive toxicity, and onco-
genicity testing.

Notice of Final  Rulemaking;          3
requires manufacturers and
processors to conduct
cfhcogenicity testing of 1,2,4-
TCB; reproductive effects testing
of MCB, 1,2- and 1,4-DCBs; repro-
ductive effects  and developmental
toxicity testing of 1,2,4,5-TCB.
This action also terminates rule-
making process for subchronic/
chronic and oncogenicity testing
of 1,2,4,5-TCB.

Notice of Proposed Rulemaking-      10
Test Standards;, proposes that
industry-submitted study plans
and schedules be adopted, with
certain revisions, as the test
standards and reporting
deadlines for the required
testing..

Decision Not to Test; announces      3
EPA is not at this time continuing
rulemaking~to require environ-
mental effects testing.

Notice of Proposed Rulemaking; to   13
perform health effects testing
for subchronic toxicity; neuro-
toxicity/behavioral effects;
developmental neurotoxicity;
pharmacokinetics; mutagenicity;
oncogenicity and dermal absorp-
tion testing.

Notice of Proposed Rulemaking-       3
Test Standards;  proposes that
pharmacokinetic testing be con-
ducted using TSCA test guidelines
for the required studies and that
test data be submitted within
specified time frames.
                                        62

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09/09/86   1,2-Dichloropropane
09/18/86   Bisphenol  A
Notice of Final Rulemaking;
requires manufacturers and
processors to test for neuro-
toxicity, mutagenicity, repro-
ductive effects, developmental
toxicity, as well  as acute and
chronic toxicity to aquatic
invertebrates and acute toxicity
to algae.

Notice of Final Rulemaking;
requires manufacturers and
processors to conduct a
90-day inhalation study with
particular emphasis on pul-
monary effects.  EPA is ter-
minating the test rule process
for acute and chronic aquatic
toxicity testing.
14.
                                Other Testing Actions
12/19/85   Polyhalogenated
           Dibenzo-p-di.oxins/
           Oibenzofurans
05/15/86   Commercial  Hexane
08/04/86   Diethylene Glycol Butyl
           Ether
Notice of Proposed Rulemaking;
requires manufacturers and
importers of 14 commercial
organic chemicals to test for
the presence of chlorinated and
brominated dioxins and furans.
Testing would also be required
on 20 other organic chemicals
(not now commercially manufactured
in the U.S. or imported) if
manufacture or importation resumes.

Notice of. Proposed Rulemaking;
to perform testing for acute and
subchronic toxicity, oncogenicity,
reproductive toxicity, develop-
mental toxicity, mutagenicity,
neurotoxicity, and inhalation and
dermal pharmacokinetics.

Notice of Proposed Rulemaking; to
perform health effects testing for
subchronic toxicity; neurotoxicity/
behavioral effects; developmental
neurotoxicity; pharmacokinetics;
mutagenicity and oncogenicity.
                                        63

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 08/12/86   1,1-Dichloroethylene
Enforceable
Consent
Agreements
Quality
of Data
                              Notice of Proposed Rulemaking;  to
                              conduct distribution, excretion and
                              metabolism (DRM) studies and a  two-
                              year inhalation oncogenicit.y Mnassa.y,
                              Oncoqenicity testing would be delayed
                              until  after DEM data Have been
                              completed and evaluated.
To initiate the enforceable consent agreements neootiation

process, EPA publishes a solicitation of interested parties

in the Federal  Register which 1) announces its tentative

evaluation of testing needs for a given chemical, ?) announces

a public meeting to discuss such testing,, and 3) requests all

persons desiring to have the status of "interested parties"

in any negotiations on the-chemical to notify EPA of their

interest.  Since publication of the Interim Final Rule, FPA

has published such solicitations on two ITC-designated chemicals, -

two'non-ITC designated chemicals and one'chemical cateoory..


In order to maintain *~he scientific integrity of EPA's' decision-

making regarding the regulation of chemicals, the Agency pursues

a rigorous program to ensure the quality of the data received as a

result of test requirements meeting established criteria.  In FY

1984, the Agency promulgated Rood Laboratory Practice (GI..P) standards

(48 FR 53922-53944, November 29, 1983).  The RLPs specify procedures

for conducting health effects and environmental effects testing

under TSCA, and requirements for facility operations, maintenance

of equipment and recordkeeping.  To ensure compliance with the GLP

standards and with testing requirements under TSCA and FIFRA,  FPA's
                                                           •
Office of Compliance Monitoring is responsible for conducting
                                          fi4

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             laboratory inspections, and for auditing completed test studies.

             Inspection staffs are drawn from EPA headquarters, Regional  Offices,

             and from the Food and Drug Administration (FDA).   The Office of

             Toxic Substances provides scientific and technical support to the

             Office of Compliance Monitoring through its Health and Environmental

             Studies Audit Program (HESAP).  HESAP staff participate in laboratory

             audits and.review test data resulting from ongoing industry  testing

             and test rules.  Inspection and study audit reports from EPA

             Regional and Headquarters Inspectors are reviewed, and regulatory

             actions recommended as appropriate.

                  In FY 1986, 16 laboratory inspections were conducted and 65

             test studies were audited under section 4 testing authority.  See

             Chapter 7 for detailed compliance and enforcement actions.


Test         Section 4 of TSCA also requires the-development and annual review
Guidelines •
             of test standards and guidelines..  Tb ensure consistency and

             scientific quality, all new guidelines are peer-reviewed by

             scientists and experts within the Agency and in the academic

             community, State and Federal agencies, public interest groups, and

             industry.

                  During FY 1986, EPA published one new test guideline,

             "Indirect Photolysis - Screening Level Test", and published  revisions

             to 37 guidelines.
                                         65

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6.  SUPPORT TO OTHER PROGRAMS, REGIONS,  AGENCIES,  STATES,  INDUSTRY

Program    The Office of Toxic Substances (OTS)  made a  major effort  in  FY
Status
           1986 to inform other EPA program offices and regional  offices,
           other Federal agencies,  and States about the chemical  information
           collected under TSCA sections 4, 5 and  8; about potential  uses
           of TSCA in filling information or control gaps  that  cannot be
           obtained through other legislative authorities; and  about  the
           technical expertise (i.e., risk assessment,  structure  activity,
           modeling) that is available for cross-media  activities.   Since
           many other programs address priority  chemical  exposure problems,
           OTS feels that these programs can benefit greatly from its
           unpublished health and safety information, and  from  its
           >xpertise. Several activities have been discussed in the
           previous chapters [i.e., in Chapter 4,  CAIR, section 8(d)
           information gathering, CEPP;  and in Chapter  5,  test  rule  develop-
           ment support]; however,  additional significant  accomplishments
           cannot be categorized under a specific  program.  These are
           discussed in this chapter.
                Two formal mechanisms were established  to  assess  the
           needs of other program offices and to determine how  to best
           meet these needs.  The Committee for  Programs'  Regulatory  Use
           of TSCA examines potential uses of TSCA, uses of OTS technical
           expertise by other programs,  and the  potential  impacts of  both
           on existing OTS programs.  The Testing  Priority Committee
                                    66

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              (TPC) examines the technical  merits of program offices'  requests
              for testinq under TSCA.  The  TPC has established a standing procedure
              for the nomination of chemicals, satisfying multiple proaram needs,
              for testing under TSCA as well  as other testing mechanisms.  In
              addition, the TPC serves as a forum for information exchange with
              respect to ongoing and planned  testing.
INFORMATION
DISSEMINATION
Chemical
Assessment
Desk
TSCATS
OTS has collected a wealth of unpublished data on chemicals as a
result of various section a and 8 rules, and has gained much exper-
ience in evaluating new and existing chemicals (i.e., hazard,
exposure, source, risk assessment, modeling).  OTS makes its
information and expertise available through the activities
below, and is continuina to explore methods to. enhance the
accessibility of TSCA data to outside users.

The Chemical  Assessment Desk pilot project was introduced in ^arch
to provide consultation on chemical toxicity and exposure potential,
based on available OTS information and evaluations plus information
from other EPA programs.  The project's initial client, Region 8,
has referred approximately 20 issues to the Chemical  Desk to
date.  In August 198fi, the pilot project was expanded to include
Region 10.  Regions 1, 4, and 9 will be added by the end of
calendar year 1986.

In December 1985, EPA. implemented the Toxic Substances Control
Act Test Submissions  (TSCATS) data base, which is an online
                                               67

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          index to tne compiled unpublished health and safety studies



          that have been submitted to EPA from chemical  manufacturers and



          processors.  This is non-confidential  information that can be



          made available to the public.  Users include Federal  and State



          agencies, researchers, risk assessors, trade and professional



          associations, and toxicologists.  The data base contains over



          10,000 citations that cover more than 1,?00 unique chemical



          substances.  Used in conjunction with published material,



          the data can help formulate hazard evaluations and risk



          assessments.





GF.MS      The Office of Toxic Substances has several information and



          model ing-systems available to hplp States deal" w-ith their toxic-



          related problems and projects.  Among the most, important is the



          Graphical Exposure Model ing System. (GFMS"), which features



          chemical property .estimation and- envi ronmenfal partitioning



          fate, and exposure models, and draws upon a wide range of demo-



          graphic and environmental  characteristics data.





Videos    In FY 198fi, FPA produced 4 videos to provide the public with



          information, clarification, or guidance on TSCA regulations.



          TSCA Inventory Update:  An Overview for Chemical Manufactures



          and Importers was produced as an instructional videotape to aid



          persons required to report during the partial  updating of the



          TSCA Inventory.  TSCA:  Balancing Risks and Benefits was produced



          to provide general information on TSCA's preventive risk/benefit
                                           fiR

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INDUSTRY
COLLABORATION
               approach, review of new chemicals before they are in commerce,

               information-gathering on chemicals of concern,  and related  issues.

               The videotape is designed to explain the Act to public health

               organizations, State governments, labor oraam'zations, public

               interest groups, a.nd'universities or secondary schools.   Deducing

               the Risks of PCBs explains the history of PCB regulation  under

               TSCA, and the effect of PCBs on health and the environment.  The

               video also focuses on the general requiregents  of the rules,

               including disposal requirements, registration of PCB transformers

               with fire departments, notification of huildinq owners,  and

               the filiag of an annual inventory report.  This tane is  dpsianed

               to explain PCBs to the utility industry, fire departments,

               building owners, and scrap and salvage Hpalers.  npn't Blow  It!

               was produced for brake and fleet garaqe mechanics and vocational

               schools; it provides information on potential health

               hazards from exposure to asbestos in brake dust, as well  as

               step-hy-step methods to effectively control  brake dust.
               A February 19P6 workshop reviewed the methods currently

               available to assess workplace exposures  to chemicals,  given  limited

               data only.  The workshop convened EPA, industry,  and academic

               representatives to address concerns about  inhalation exposure,

               dermal  contact, engineering controls, and  respiratory protection.

               For many participants, the workshop served to clarify thp

               regulatory, temporal, and economic limitations under which  FPA

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            operates its new chemicals  program.   The  workshop  also  enabled
            EPA to draw upon considerable  external  expertise to  help  advance
            the technical  tools  and  procedures the  Agency  uses to assess
            new chemicals  and workplace exposures.
                 Another example of  industry  collaboration was a national
            conference on  risk communication  held in  January 1QP6.  The
            conference was co-sponsored by the Conservation Foundation, the
            National Science Foundation, the  American Industrial Health
            Council, and the University of Southern California.  Government,
            industry, environmental, and consumer leaders  discussed new
            and practical  ways to communicate about health, safety, and
            environmental  risks  from hazardous wastes,  nuclear energy, and
            pesticides.
TECHNICAL
EXPERTISE
            In addition to providing test  rule development and data-gathering
            support, OTS made its expertise available to other EPA  programs.
            One particular example of a unique scientific  expertise OTS
            possesses is the Office's ability to evaluate  the  potential
            hazards of chemicals for which adequate test data  are lacking.
            Through its experience in assessing  new chemical substances over
            the past six years,  OTS  has developed a special expertise and
            recognition in the application of structure-activity relationships
            (SAR) to the evaluation  of  chemical  hazards.   During FY 1P86, OTS
            assisted a number of other  groups by providing high  quality hazard
            assessments of a variety of poorly studied chemicals.   For example,
            OTS assisted the Office  of  Pesticide Programs  in evaluating the health

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         and environmental effects of 37 pending pesticide inert inqredients.

         OTS also assisted the Office of Solid Waste and Emergency Response

         (OSWER) hy providinq SAR-hased analyses of potential  carcinooenicity

         and chronic toxicity of 515 chemicals on the Comprehensive Environmental

         Response, Compensation and Liability Act fCFRCLA) "Reportahle

         Quantity" list.  During FY 1QS6, OTS also assisted several States

         and EPA reqions as well as the U.S. Departments of State and

         Defense by providina SAR-hased analysis of a variety  of chpmicals

         including environmental pollutants, chemical tracking agents,

         research and development chemicals, etc.

              OTS technical expertise supported the Office of  Water Peculations

         and Standards' Effluent Guideline on the Orqanic, Plastic and

         Synthetic Fibers Industry-.  The information that OTS  proviripd or

         developed included 1^50 data, hiocohcentration-, half-lifp in water,

         cancer risk values, and otHpr faf.e and transport values.

              OTS also, provided Region 7 with-a.ll the information needed

         to evaluate its need for an information services unit.

STATE
PROGRAM
         The exchange of information between States and EPA benefits both.

         The States benefit by gaining access to chemical information that

         can help them develop solutions to local toxics problems that may

         not he addressed hy Federal authorities.  EPA benefits hy receiving

         information (e.g., data on release, exposure, pt.c.) from the

         States which can help the Agency anticipate and plan  solutions

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to emerging problems.  A mutual benefit of information exchanae



is the use of similar rlata; this will  hopefully lead fo



standardizing regulations developed at the .State and. Fedprai




levels.



     To facilitate the exchanae of toxics information and



technical  expprtise between State and  Federal  officials, a forum



was provided throuqh a grant with the  National Governors'



Association (NGA), which sponsors conferences  and workshops of



this nature.  FY 1986 conference topics included:  Chemical



Safety and. Emergency Preparedness; Indoor Air  Pollution:  Total



Exposure to Toxics; and a workshop entitled Designing a Risk



Assessment Office.  In addition, the NfiA grant provides- an



information clearinghouse and ripvelnps "how-tri" memoranda, issue




briefs, and conference proceedings.



     Additional  meetings with Strate officia-ls' have~ taken



place with representatives of key States includinn California,



Michigan, North Carolina, Maryland, South Carolina, Virninia,



Kentucky, New Jersey, Minnesota, and Illinois.  These meetinos



have had two main purposes:  to determine common areas of concprn



in the toxics mananement area; and to  promote  the exchange of



risk information, health and safety data, the  availability of



on-line data assistancp, and thp exchange of information regardina



ongoing studies of specific chemicals.  The target audiences



for such briefings include staff of State environmental (natural



resources), public health and agricultural departments.

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MINET
         In another effort to inform States  of TSCA  information  and

         activities, OTS has joined a telecommunication*;  network,  the

         Medical  Information Network (MINET) which has  43 State  health

         departments online.  In FY 198fi,  OTS sponsored 13 Statp

         environmental  departments  to enable them to sinn on  to  the

         system as well.  MINET notifies  States of key  Federal Register

         notices;  of new assessments and  health data; of  the  availability

         of Chemical Hazard Information Profiles (CHTPs)  documents;  of

         regulatory aqenda; and of  conferences, meetings, and seminars.

         Through  MINET,  States may  request information  on specific chemicals

         that are  related to their  own State activities.

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   7.  COMPLIANCE AND ENFORCEMENT
            EPA has developed specific strategies  to  enforce  regulations  under
            TSCA.   These strategies identify and rank possible violations,
            identify the available tools  for compliance  monitoring,  specify
            how these tools are to be used,  and provide  a  formula  to determine
            the applications of inspection  resources. Where  inspections  uncover
            violations of TSCA requirements, EPA levies  civil  penalties,  as
            authorized by section 16 of TSCA.
PROGRAM
ACTIONS
            During FY 1986,  EPA developed and issued compliance monitoring
            strategies for the Asbestos Abatement. Projects  Rule and.the  PCB
            Transformer Fires Rule.   EPA also developed and issued  an  Amendment
            to the Revised Asbestos-In-Schools Enforcement  Response Policy,
            and.Interim Final Amendments to the Enforcement Response Policy
            for TSCA section 13 (imports) and TSCA section  8(a) (reporting
            rules)..
                 EPA continued cooperative enforcement programs to  monitor
            compliance with  the PCB  regulations in the States of Connecticut,
            Florida, Maryland, Michigan, New Hampshire, North Dakota,  Ohio  and
            Texas; and cooperative enforcement agreements  to monitor compliance
            with Asbestos-In-Schools regulations in.the States of Arizona,
            California, Colorado,  Idaho, Iowa, Maryland,  New Hampshire,  Oklahoma,
            Texas, West Virginia and Wisconsin.  In FY 1986, the States  conducted
            732 PCB compliance inspections and 877 Asbestos-In-Schools compliance
            inspections.
                                             74

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COMPLIANCE
ACTIONS
                  The California and Idaho Ashestos-In-Schools  cooperative  enforce-

             ment agreement programs were completed in  FY 198*.   For  the  .States

             of California, Kansas, Puerto Rico and Washington,  PCP cooperative

             enforcement agreement programs were initiated late  in FY 1986.
             In FY 1986, EPA conducted a hroad range of insppctions  for  TSCA

             reguirements.  FY 1986 was the first  year in  which  FPA  conducted

             asbestos worker protection inspections.  Fifty-five of  these

             types of inspections were carried out.   The FPA,  alono  with piqht

             State agencies cooperatina under the  terms of enforcement grant.s-

             in-aid, conducted ?,371 PCP compliance  monitorina inspections.   In

             addition, the Agency, operatinq under a cooperative agreement with

             the American Association of Retired °ersons and  fhp Statps  of

             Arizona, California, Colorado, Idaho, Iowa, Maryland, New Hampshire,

             Oklahoma, Texas, West Virginia and Wisconsin, conducted 3,?7n

             Ashestos-in-Schools inspections.

                  During FY 1986, the Agency also  monitoring  compliance  with

             TSCA section 4, 5,  8, and 13 reguirements.  FPA  inspected 1.6

             laboratories conducting testing under TSCA to determine if  the

             laboratories were in compliance with  Good Laboratory Practice

             (GLP) reguirements.  During these inspections FPA conducted 65

             audits of health and environmental  tests to determine if testing

             had been conducted  according to test  protocols,  and if  reoorts

             accurately reflected study findings.   EPA also conducted over
                                              75

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CIVIL
ENFORCEMENT
ACTIONS
              inspections to determine compliance wifh section R and 8 require-

              ments.  The Agency conducted a total  of 1,005 inspections to

              determine compliance with section 13 chemical import requirements.
              Again in FY 1986, the number of administrative complaints issued

              by the Regions increased over those issued in FY 1Q85.   A total  of

              781' administrative complaints were issued in FY 1Q86 compared to

              733 in FY 1985.   For allege^ failure to comply with the import

              certification requirements (section 13), the Aaency issued ?3

              civil administrative-complaint's..  The Aqency also issued-APS civil

              administrative complaints for alleged violations of the section  fi

              asbestos-in-schools requirements and 3?3 administrative complaints

              as* a result of PCR inspections...  Tn addition, FPA--issued .? civil

              complaints, for a-lleaed violations'of section s(a),  and  R civil

              complaints' for alleged violations of section 5.  Hqures for each

              EPA Regional  Office and Headquarters appear in Table 5.

                   The following are case summaries of sianificant TSP.A.civil

              administrative and judicial cases concluded during  FY 1Q86.

              United States vs. Southeastern Pennsylvania Transit Authority

              (Civil Action 86-1094  E.D. Pa) - Paoli, Pennsylvania.   This TSCA

              section 7 emergency action, filed jointly as part of CERCI.A and

              RCRA action,  is  addressing the imminent hazard to health and the

              environment posed by massive PC8 contamination at the Paoli

              Railyard near Philadelphia.  The Paoli  Railyard serves  as the

              major northeast  junction and repair terminal for commuter trains
                                           76

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owned and operated by Septa, Amtralc and Conrail, the joint
defendants.  The civil action souqht. the cleanup of all  PCR
and PCB-related toxic substances at the Paoli Railyard and
the surrounding area.  Extensive contamination of adjacent
residential areas is being addressed on an emergency basis by
an EPA-constructed surface runoff containment system, and by
related removal actions.
Union Carbide Corporation (Docket No. TSrA-flS-H-n?) - nanhury,
Connecticut.  This administrative penally enforcement action
charged Union Carbide with the failure to provide to the Agency
substantial risk information, namely, a cancer study on  diethyl
sulfate, as required by section 3(e) of TSCA.  Following a ypar
of administrative litigation, the innovative settlement  agreement,-
which i* oresently before the Judicial Officer for approval, requires
a comprehensive environmental audit of the comoany's risk information
and provides for a novel alternative dispute resolution  (Anp)
procedure, the first such use of ADR in an FPA enforcement action.
BASF Systems Corporation fPocket No. TSCA-85-H-nd) - PedfnrH,
Massachusetts.  In this action, BASF voluntarily disclosed that- it
imported and used chemical substances that had not been  listed on
the TSCA Chemical Substances Inventory, which constitutes a violation
of the section 5 premanufacture notification requirements of TSCA.
In the settlement of the subsequent enforcement action,  RASF aoreed
to pay a fine of $80,000 and to initiate a comprehensive environmental
compliance audit of its operations at- Bedford, Massachusetts.  BASF
is required to report any violations discovered in the course of the
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audit to EPA within 15 days- of discovery, and pay a minimum



penalty of $10,000 for each chemical  violation reported for



chemicals that do not represent a threat to health or the



environment.  For other chemicals, E°A is free to seek the



maximum civil penalty.  In addition to these terms, RASF



agreed to conduct an evaluation of the TSCA compliance program



of its parent corporation, PASF, A.R., of West Germany.



United States vs. Commonwealth Edison (Civil Action P4-C-1.507,
N.D. IL) - Chicaao, Illinois.  Thp Consent Pecree in this



enforcement action, signed in FY 1986, resolves FPA charoes



that Commonwealth Edison was not properly decontaminating



spilled PCBs from pole-mounted electrical capacitors-, which



resulted in residual contamination as high as.^.fiOD - 33,-5nn pnm.



The company agreed to conduct soil samplina and analysis for thp



presence of PCBs at an pstimated' Son spill' sifes in Northern



Illinois, and will decontaminate to an FPA approved level an



additional estimated 3^0 spill sites.  As part of this settlement,



Commonwealth Edison is also scheduled to remove all pole-mounted



capacitors by January 19*7.



DuPont Corporation (Pocket No. TSCA-8fi-H-01 ) _ Wilmington, Delaware.



In this action, DuPont was charged with violations of TSCA section



5 premanufacture notification requirements for new substances and



paid a ^100,000 civil penalty.



     Under the terms of settlement, DuPont 's Finishes and



Fabricated Products Department, the Division involved in this action,
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is required to formalize a series of TSCA section 5 compliance
assurance procedures.  These procedures were compiled into a
guidance manual for employees affected by TSCA requirements.
The manual has been distributed at plants and laboratories
throughout the country.  Training programs, with respect to
the compliance procedures, have been held at many of DuPont's-
facilities.
     The settlement required DuPont to produce a broadcast quality
videotape on the requirements of TSCA, to be used as part of the
company's employee education program on TSCA compliance.  In addition,
DuPont is developing an "artificial input" system to monitor TSCA
compliance. .Under this program, test inputs will be designed to
test the company's ability to recognize and prevent the unlawful
manufacturing or importation of new. chemical- substances that are
not on the TSCA Inventory, and the release of new products containing
components that are not on the Inventory.' Results of these tests
will be reported to'EPA.
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Table 5     Administrative Civil  Actions  Taken under section  16  of  TSCA,  Complaints
            Issued, Cases Completed,  and  Amounts  Assessed  (by Region)*
Region
1
2
3
4
5
6
7
3
9
10
HQ
TOTAL
Total No.
Complaints
Issued
FY' 79-86
110
350
193
184
'615
221
261
215
149
171
29
2,498
No.
Complaints
Issued
FY'86
31
110
61
34
162
63
76
85
64
89
6
781 1
Total No.
Cases
Completed
FY1 79-86
59
218
119
137
419
126
133
122'
92
53"
19
,497
No. Cases
Completed
In
FY'86**
18
62
25
23
105
22
13
43
40.
10
2
363 1
Total No.
of Cases
Pending
51
132
74
47
196
95
128
93
57
118
10
,001
Total Civil
Penalties
Collected
($) in FY'86
133,504
632,030
262,670
37,855
802", 490
191. ,.780
122,380
60,000
191,330
288,955
160,000
2,882,994
Total Penalties
(In $) Collectec
FY'79-86
483,735
2,405,815
803,805
429,527
5', 236, .879
1,536,245
511,035
461,515
692,455
438,095
1,954,750
14,953,856
 * All  actions taken involved alleged violations  of TSCA sections  4,5,6,8,  and/or  13.
** Includes cases carried over from FY 1980 -  FY  1985.
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8.  LITIGATION
         ENVIRONMENTAL DEFENSE FUND,  INC.  v.  ENVIRONMENTAL PROTECTION  AGENCY
         (No. 79-1580, D.C. Cir.)

         In 1979, the Environmental  Defense Fund (EOF) petitioned for  review

         of EPA's regulations under TSCA section 6(e)(2)  and (3)  governing

         the manufacture, processing, distribution, and use of polychlori-

         nated biphenyls (PCBs).   A decision  largely in EDF's  favor was

         issued on October 30, 1980.   This decision and its aftermath  were

         described in reports for previous years.   As a result of the

         Court':; orders in this case, EPA has issued three additional  PCB

         rules.  In August 1982,  EPA  issued a regulation  affecting the use

         of PCBs in electrical equipment;  in  October 1982, the Agency

         issued a rule providing  an exclusion from the'Statutory  ban for

         PCBs produced in closed  manufacturing processes  or.discharged into

         wastes that are disposed of  in an acceptable manner;  finally, in

         July 1984, EPA issued a  regulation affecting other PCBs  inadvertently

         generated in chemical manufacturing  processes.  These rules,  in

         turn, have generated other litigation and other  regulation.

         Litigation developments  for  FY 1986  are described below.

              August 1982 electrical  equipment rule.  Previous TSCA Annual

         Reports described the litigation and subsequent  additional rules

         resulting from the August 1982 rule.  One of the additional rules,

         issued in July 1985, placed  additional  restrictions and  conditions

         on the use of PCB transformers.  The July 1985 rule generated

         another lawsuit — MISSISSIPPI POUER COMPANY v.  EPA (No- 85-4498,
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5th Cir.).  No further action has been taken in this case in FY 1986
pending the outcome of settlement negotiations.
     October 12, 1982, closed manufacturing processes rule.  The
Chemical Manufacturers Association (CMA) filed a petition for review
of this rule in December 1982 — CMA v. EPA (No. 82-2518, D.C. Cir.).
This suit was rendered moot as a result of developments in the suit.
on the July 1984 rule, discussed below.  In August 1986, the Court
approved a joint motion to dismiss.
     July 1984, inadvertent generation rule.  In late September 1984,
petitions, for-review of the July. 1984 rule were filed by the-American
Die Casting Institute and Outboard Marine Corporation in the Seventh
Circuit, and by the American Paper Institute and Fort Howard Paper
Company in the D.C. Circuit.,  The Seventh Circuit petition was
transferred to the D.C., Circutt where the Court consolidated all
cases — AMERICAN PAPER INSTITUTE v. EPA (No.  84-1481, D.C. Cir.)
and CONSOLIDATED CASES.  The Chemical Manufacturers Association was
granted permission to intervene.
     A Settlement Agreement was filed with the Court in August 1986
by most of the parties.  Fort Howard Paper Company opposed the
Agreement.  EPA has agreed to propose and obtain public comment on
amendments to the rule that may allow certain  activities involving
existing stocks of very low level PCB products and materials.  EPA
also agreed to make a final decision on the proposal within specified
time frames.  The other settling parties agreed to dismiss the case
if EPA issues a final rule substantially similar to the proposed

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amendments.  The Court is asked to hold the proceeding in abeyance

until the rulemaking is completed.

     Fort Howard Paper Company requested the Court not to wait for

the outcome of the rulemaking but to order EPA to issue a water

discharge effluent standard under TSCA for companies recycling paper

contaminated with low levels of PCBs.  EPA argues that Fort Howard

will have the opportunity to raise its issues in the rulemaking

proceeding and that the Court should not waste judicial resources by

dealing with the issue before EPA has had the opportunity to consider

Fort Howard's position.  The parties are awaiting the Court's final

decision on approval  of the Settlement Agreement.

N.Q.C... Inc., t/a Noble Oil Company v. Administrator,  (No. 85-3175
3rd Cir.) and (No. 85-1650, U.S. Supreme Court)

The Circuit Court of Appeals j'ssued'an opinion affirming EPA's

assessment against Noble Oil Company of a civil penalty of $40,000"

for three separate violations of Agency regulations on disposal,

marking and storage of PCBs.  Arguments raised by Noble Oil were

discussed in last year's Annual Report.  Thereupon, Noble Oil sought

review in the U.S. Supreme Court, arguing among other things that

(1) the PCB regulations were unenforceable because they were

invalidated by the D.C. Circuit in 1979 (see ab-ove) and (2) the

Administrator's decision was not supported by substantial evidence.

The Supreme Court denied review on June 23, 1986.

Service Employees International Union (SEIU) v. Ruckelshaus,
(No. 84-2790, D.D.C.)

SEIU brought this action in September 1984 to require EPA to issue (1)
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Federal regulations setting standards for determining when an
asbestos hazard requiring correction exists in schools and other
public and commercial  buildings, (2) requirements for abatement
activities where such hazards exist, and (3) standards for performing
abatement activities,  including standards for the protection of
persons performing abatement.
     In early proceedings SEIU asked the Court for a preliminary
injunction, arguing that EPA had a mandatory duty to issue such
rules based on promises made by the Agency in response to citizens'
petitions.  Alternatively, SEIU argued that EPA had failed to complete
rulemaking actions on asbestos hazards, in a reasonable time-
     On November 16, 1984, the Court denied the preliminary injunction
because. EPA was "actively pursuing: new. approaches for asbestos
abatement," and because EPA has-. In place a voluntary/regulatory
asbestos program.   Further, the Court determined that deference to
EPA was appropriate, citing EPA's assurances that it would shortly
issue a final decision on the most feasible asbestos regulatory approach.
     On November 30, 1984, EPA issued a final decision with respect
to certain parts of SEIlTs request, stating that it would not issue
regulations governing decisions affecting asbestos abatement activities
because such decisions are best made at the local level, and the
Agency's current program and planned improvements should adequately
deal with the problem.  EPA, however, continued with rulemaking
efforts related to protection of workers conducting abatement
activities and protection of building occupants during abatement.
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Activities in this area are discussed elsewhere in  this  report.
     SEIU amended its complaint,  asking the Court to reverse  EPA's
decision not to issue some of the regulations  requested,  claiming
that EPA's program is not adequate to deal  with the asbestos  hazard
in schools and other buildings.
     By the end of FY 1985, SEIU  and EPA had filed  written  arguments
supporting their respective positions.   A hearing before  the  Court
on pending motions was held in October 1985.  In September  1986,
the Court issued an order indicating it intended to hold  a  new
proceeding on SEIU's request.  As of the end of FY  1986,  the  Court
had not yet issued an opinion stating its reasons or an  order
governing further proceedings.
Environmental Defense Fund (EOF)  and National  Wildlife Federation
(NWF) v. Thomas, (No. 35-0973, D.D.C.)   '':'
Plaintiffs brought this action after EPA had denied, in  part, their
citizens' petition to issue comprehensive regulations under TSCA
on certain isomers of the chemicals known as dioxins.  These  are
substances chemically similar in  structure to  2,3,7,8-tetrachlorodibenzo-
p-dioxin (TCDD) and which, according to plaintiffs, may  present
risks similar to TCDD.
     In early 1986, plaintiffs filed a motion  requesting  the  Court to
order EPA to initiate rulemaking  because the Agency had  improperly
denied their petition.  EPA opposed plaintiffs' request  arguing that
its denial was in accordance with statutory requirements.  The
parties are awaiting the Court's  decision.
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Polaroid Corporation v. United States Environmental Protection
Agency and William M. Ruckelshaus (No. 84-3134-K, D. Mass.)
In October 1984, Polaroid Corporation (Polaroid) challenged EPA's
disclosure and handling of information, submitted by Polaroid under
TSCA which had been claimed as confidential  (confidential business
information) under both section 14 of TSCA and EPA's confidentiality
regulations  in 40 CFR Part 2.  Polaroid challenged EPA's making
disclosures  of such confidential business information to certain EPA
contractors  and subcontractors, other Federal agencies, and certain
arms of Congress and challenged the adequacy of EPA's security and
handling of  such information.  Further, Polaroid alleged that some
of EPA's actions violated the settlement of  a previous Polaroid suit
involving confidentiality issues in 1978 (Polaroid Corp. v. Costle
.No. 78-1133S, 0. Mass.).  Polaroid .sought declarative and injunctive
relief..
     Polaroid requested and was granted expedited discovery which
focused primarily on EPA's physical handling and security of
confidential business information under the  procedures in EPA's
"TSCA Confidential Business Information Security Manual"" and the
related manual "Contractor Requirements for  the Control and Security
of TSCA Confidential Business Information."  In January 1985, Polaroid
unsuccessfully sought a temporary restraining order which would have
severely constrained EPA's review of certain premanufacture notices
submitted by Polaroid under section 5 of TSCA.
     After further discovery, EPA and Polaroid entered settlement
negotiations.which resulted in the District  Court's entering a
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Consent Order.  The Consent Order addressed two areas.   First,  EPA

was in the process, separate from this litigation,  of making certain

refinements of its security procedures for handling and protecting

TSCA confidential business information, including revisions of  its

security manuals.  With respect to those refinements, EPA agreed

to report to the Court when they were completed.  Second, in the

course of settlement discussions, EPA and Polaroid identified

certain additional refinements which EPA concluded would be

worthwhile.  The Consent Order committed EPA to making those

additional refinements and to reporting to the Court when they

were completed.

     The Court dismissed the case on September 4, 1986, after the

last of the requirements of the Consent Order were met.

Chemical Manufacturers Association v. Environmental. Protection
Agency (No. 84-1569, D.C. Cir.)

On November 19, 1984, the Chemical Manufacturers Association (CMA)

filed a petition for review of the first significant new use rule

EPA promulgated under section 5(a)(2) of TSCA.  The rule was

promulgated on September 5, 1984 (49 FR 35011) and related to two

chemical substances which were the subject of premanufacture notices

under section 5 of TSCA.  The rule also included general procedural

provisions that will be applicable to all significant new use rules.

In the course of informal discussions, CMA indicated that it was

concerned about some of these procedural provisions.  EPA indicated

that it was willing to undertake further rulemaking on these provisions

which was likely to meet these concerns.  Accordingly, CMA agreed to
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defer briefing until EPA proposed revisions to these procedural
provisions.  The revisions were proposed on April  22, 1986.
     CMA and EPA entered into a settlement agreement under which CMA
will voluntarily dismiss its action if EPA promulgates revisions
substantially similar to those proposed.  Further action in  this
case is stayed pending completion of the rulemaking.
Citizens for a Better Environment, et al. v. Lee M. Thomas
(No. 85 C 08000, N. 111.)
In September 1985, two public interest, groups challenged EPA's
decision denying their petition filed in April 1985, pursuant to
section 21 of TSCA.  The petition had requested EPA to identify
business entities in the southeast area of Chicago which were
releasing 1.1. named chemical substances into the environment, and. to
initiate rulemaking under TSCA section 4(a) to require testing on
the chemical substances — including.testing for cumulative  and
antagonistic effects.  EPA denied the petition, in part, on  the
basis that there are no available test standards for studying
cumulative effects of chemical substances.  In addition, the
denial notice indicated that health effects data were adequate for
regulatory assessment.  Finally, the notice stated that EPA  had
already identified 44 businesses in-southeast Chicago which  emit
pollutants into the air, and that EPA was conducting a variety of
environmental investigations in southeast Chicago.
     The discovery process, wherein each side may request documents
and depositions from the other side, has been initiated and  may
continue until the spring of 1987.

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Shell Chemical Co. v. EPA (No. 86-4161, 5th Cir.) and Shell
Chemical Co. v. Thomas (No.  86-2671, D.D.C.).
On January 7, 1986, four manufacturers of mesityl oxide and the
Chemical Manufacturers Association filed in the Court of Appeals a
petition for judicial review of EPA's final rule requiring health
effects testing of mesityl oxide (Shell v. EPA).  The rule was
published in the December 30, 1985 Federal Register (50 FR 51857).
The proceeding was held in abeyance pending EPA's consideration of
the manufacturers' petition  under section 21 of TSCA to withdraw the
test rule.  EPA denied the petition on August 21, 1986 (51 FR
30216).  The manufacturers have informed the Court that they will
reinstitute the lawsuit.
     The four manufacturers  have also filed an action in District
Court, on September 26, 1986, challenging the denial  of their section
21 petition (Shell v. Thomas).  Th-is District Court action may be
stayed pending the outcome of the reinstituted lawsuit in the Court
of Appeals.
Jack Pierce, d/b/a Jack Pierce Waste-Oil. Inc. v. EPA (No. 86-1486,
7th Cir.):
Jack Pierce seeks review of  a $29,000 penalty assessed by EPA for
violation of the Agency's PCB disposal regulations.  Pierce challenges
EPA's determination that he  owned the tanks from which PCBs spilled
and the legal conclusion that he could be held personally liable for
a violation alleged to be caused by his business.  The case is being
held in abeyance pending the outcome of settlement negotiations.
New Orleans Public Service.  Inc. v. EPA (No. 86-4577, 5th Cir.)
New Orleans Public Service,  Inc. seeks review of a penalty assessed
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by EPA for improper disposal of PCB-contaminated transformers.
The administrative record of the penalty proceeding before EPA has
been filed with the court.  Briefs containing legal arguments are
expected to be filed shortly.
U.S. v. Cannelton Industries, Inc. (No. 83-2406, S.D.W.Va) and
CONSOLIDATED CASES.
This group of three cases resulted from a spill  of PCBs from a
transformer in an underground mine operated by Cannelton.  EPA
filed a complaint alleging Cannelton violated the Agency's regulations
regarding disposal of PCBs.  Cannelton filed two suits against EPA.
One suit requested that the court declare Cannelton's rights and
resppnsibilites with respect to storage and disposal of PCBs in its
mine.  In the second sui.t, Cannelton requested- the Court to order
EPA to .initiate a'proceeding .to amend .its PCB disposal rules.  EPA
and Cannelton reached an agreement on cleanup of the. PCBs, which
was approved by the Court in February 1986.  The court has retained
supervisory jurisdiction over the agreement.
     Two suits were filed against EPA regarding the Agency's
consideration of whether to allow a PCB disposal facility in
Henderson, Kentucky.
Michael D. Vanderveer and City of Evansville, Indiana v. EPA and
Unison Transformer Services. Inc. (No. EV86-183C, D.C.Ind.)
Plaintiffs requested a preliminary injunction to prevent a trial
demonstration, approved by EPA, of Unison's PCB disposal process.
The process chemically separates PCBs from transformer fluid.  The
PCBs are then shipped to other facilities where permanent disposal
takes place.
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     In support of the preliminary injunction plaintiffs argued that
the City of Henderson, Kentucky had failed to comply with.its
procedures for issuing zoning permits before the trial  demonstration
was authorized.  The Court denied the preliminary injunction on
September 11, 1986, stating that the citizens did have  an adequate
opportunity to present their views before the zoning authority.
     Plaintiffs also requested a permanent injunction against
operation of the facility, stating in their complaint that EPA needs
to consider criteria applicable under the Resource Conservation and
Recovery Act (RCRA) in addition to criteria under TSCA  when approving
the Unison facility and that the operation of the facility would
present an unreasonable risk of harm to plaintiffs.   Further
proceedings on the permanent injunction are expected during FY
1987.
Citizens for Healthy Progress, Inc. v. EPA (No.  86-0155, D.C.
Kentucky]
Plaintiffs in this suit, filed on September 18,  1986, are requesting
temporary and permanent injunctions to prevent EPA from allowing
operation of the Unison facility.  The Complaint states that the
permit for the facility should only be granted after consideration
of RCRA criteria, not criteria under TSCA, and that they are unable
to evaluate the risks caused by the facility because EPA and Unison
have not disclosed the identity of the chemical  used to separate
PCBs.  Further proceedings are expected in this  case in FY 1987.
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9.  INTERNATIONAL ACTIVITIES
         Since" the passage of TSCA,  EPA has been involved in  a  number of
         international  activities to promote coordinated approaches  to
         evaluating and managing toxic substances.   The Agency  considers
         these programs of critical  importance,  and continued to play a
         very active role during FY  1986.   EPA's i-nternational  activities
         include the exchange of information and expertise, which provides
         significant benefits to several  international  organizations.
              One of its most visible and  successful  international  efforts
         is its participation in the Chemicals  Group and Management  Committee.
         of the Organization for Economic  Cooperation and Development
         (OECD).  The OECD, a 24-member international organization  comprised
         of the world's major industrialized nations, was founded both
         to. promote the development  of, and. to  prevent barriers to,.
         international  trade. .Due to a proliferation of national chemical
         laws during the. 1970s,  the-OECD membership recognized  the  potential
         for chemical trade barriers.  It  therefore established a program
         in 1977 to develop harmonized approaches to the review, evaluation
         and management of toxic substances.
              During FY 1986,. EPA continued to  build on several important
         initiatives and, through continuing preparations for a third
         meeting of the Chemicals Group at High Level (HLM III), to define
         a framework for Chemicals Group and Management Committee activities
         into the next decade.
              Three early efforts in the Chemicals Program involved hazard
         assessment, good laboratory practice and confidentiality of data;
         important followup work was also initiated in 1985.   During 1986,
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significant progress was made in each of these important areas.
Responding to previous recommendations of hazard assessment experts
that the initial work in this complex area should focus on exposure
assessment, a Workshop on Practical  Approaches to the Assessment
of Environmental Exposure convened in Vienna, Austria, in April
1986.  The Workshop produced reports summarizing the technical
methodologies Member countries use for conducting environmental
exposure assessments in three areas  Source Characterization, Fate
and Pathways, and Targets of Exposure.  U.S. experts were generally
pleased with the outcome.  Further work on hazard assessment will
be developed and undertaken under the supervision of the newly
established Hazard Assessment Panel, which the U.S. chairs..
     With regard to Good Laboratory  Practice, GLP experts met twice
during 1986 and. reached agreement on two basic'documents: the Guide
for Compliance Monitoring Procedures for Good Laboratory Practice
and Guidance for the Conduct of Inspection and Study Audits.
Although the group agreed that it had completed its major tasks
and should not continue after May 1987, it also recognized that
GLP experts should continue to meet  periodically to exchange
information and experiences in GLP implementation.
     An expert group on confidentiality met twice during 1986 to
continue efforts to develop a model  form for agreements for the
exchange of confidential information.  After initial difficulties,
this group has succeeded in producing a model form for bilateral
agreements, as well as guidance for countries negotiating such
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agreements that is designed to highlight important  issues  for
consideration during negotiations.
     In the area of existing chemicals,  the pilot phase of the
Chemical Information Switchboard,  which  began with  six  countries
(including the U.S.) during 1985,  continued operations  during  1986
to increase Member state access to unpublished information on
chemicals.  Early in the year, agreement was reached with  other
pilot members to increase the number of  allowable requests from
two to four per month, since the Switchboard seemed able to
accommodate such an information exchange.   An evaluation of the
usefulness of the Switchboard will  be initiated late in 1986 and  a
determination made concerning the  expansion of the. Pilot to all
OECD Member states.
     Increasingly, EPA's attention and efforts have focused on
preparations for the third meeting of the Chemicals Group  at High
Level (called HIM).  These HLMs occur periodically  to review work
in the Chemicals Program and, more importantly, to  give guidance
for the nature and direction of future work.  A special Steering
Group to prepare for HIM III met three times in 1986 to discuss
HIM documents on:  past Chemicals  Program achievements, Chemicals
Safety Testing and the Use of Animals, Cooperation  on Existing
Chemicals Investigation, Chemicals Risk  Management, and the Future
of the Chemicals Program.
     The Ongoing Chemicals Program activities that  are  important
to OTS are the Test Guidelines Updating  Panel and the Complementary
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Information Exchange Procedure.  During the past year, four new
guidelines in genetic toxicology were adopted by the OECD Council.
The Updating Panel endorsed revisions to three acute toxicity
guidelines, primarily as a result of ongoing a.nd increasing
concern for animal welfare.  This concern was apparent
at two meetings during 1986, an experts meeting in April  on acute
toxicity testing, and a Seminar on Chemicals Testing hosted by the
government of Sweden in May.
     The Complementary Information Exchange Procedure was
established in 1978 to provide Member states early notice of
regulatory plans or actions.  The U.S. has historically sent more
information through this system than other Member countries. .However,
as more and more countries have legislation or regulatory action to
report, the system is' being used to- an increasing degree..
     EPA also participates in several programs of the United Nations,
such as the United Nations Environmental Program (UNEP) International
Register of Potentially Toxic Chemicals (IRPTC) and the World Health
Organization (WHO) International Program on Chemical Safety (IPCS).
The basic objective of the IRPTC is to promote more efficient use
of national and international resources in the evaluation of
chemicals.  EPA supports IRPTC by providing scientific and regulatory
information on chemicals, and by responding to chemical inquiries
relayed through IRPTC headquarters in Geneva.  In 1986, the IRPTC
assumed responsibility for compiling regulatory information on
chemicals slated for inclusion on the U.N.'s Consolidated List of
Banned, Withdrawn or Severely Restricted Products.
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     A UNEP group of experts continued work during 1986 on the
development of guidelines for the exchange of information related
to banned .or severely restricted chemicals in international  trade.
An information exchange scheme on such chemicals, which closely
resembles EPA's existing export notification procedures has been
in operation on a provisional basis since 1984.  The experts will
meet to finalize the guidelines in February 1987.
     The IPCS was established in response to the need for a
collaborative international approach to evaluate the effects of
chemicals on- health and' the environment.  Member state experts
work within the .IPCS to develop assessment documents on chemicals,.
set exposure guidelines, coordinate testing when appropriate, and
promote technical cooperation and. training.,  OTS has been the-1 lead-
in preparing'the IPCS assessment document on gly.c"ol ethers and-
also will be preparing such documents for nitrobenzene, 2-nitro-
propane, chloroparaffins and methyl ethyl ketone.  In response to .
the Bhopal tragedy, IPCS launched an effort to promote
international  chemical safety.  The first steps of this effort
include projects on reactive intermediates, and the identification
of national emergency response mechanisms and reported incidents.
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10.  RESEARCH AND DEVELOPMENT ACTIVITIES
         Toxic substances research provides support to meet the current and

         future needs of the Toxic Substances Control Act.  Research

         efforts are geared toward providing scientifically valid yet cost-

         effective evaluations of the risks associated with the manufacture

         and use of new and existing chemicals.

              The research program in support of TSCA develops, evaluates,

         and validates health and environmental test methodologies and

         procedures to improve the predictability of human risk estimates

         and to develop exposure monitoring systems, environmental fate and

         effects methods, and develops guidelines to perform environmental

         risk assessments.  Additional research develops and evaluates

         release and control methods for new and existing chemicals, structure-

         activity relationships as predictors of chemical fate and/biological

         effects, and procedures for ensuring the human and environmental

         safety of the products of biotechnology.

MAJOR
RESEARCH
ISSUES

Test Method Development

              Under TSCA, manufacturers must test chemicals for potential

         hazards to human health and the environment.  Consequently,

         research is conducted to provide guidance for performing such

         tests,.  Regulatory decisions on a chemical depend on qualitative

         and quantitative scientific data from industry regarding the

         potential adverse environmental and human health effects of
                                     97

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         exposure to the chemical.  Sensitive, reliable, cost- and time-



         effective tests are needed;  therefore, the Agency is developing



         and approving carefully screened methods.  Such methods will  he



         incorporated into testing guidelines for use by industry and



         others who must evaluate the safety of chemicals.





Structure Activity .Relationships (SAR)



              To enhance the efficiency of the regulatory process for  toxic



         chemicals, EPA groups various  chemicals which share common or



         similar chemical  characteristics instead of dealing separately



         with each individual  chemical.  If it can he demonstrated



         that chemical  relationships, such as similar molecular structures



         and simiTar modes of toxic activity, form a-firm scientific basis



         for estimating probable environmental risks, then better guide-



         lines and techniques can be  applied and regulatory actions can he



         completed more quickly using less resources.  The SAR approach



         is vital for reviewing and screening new chemical substances



         under section  5 of TSCA.  The  findings and techniques established



         in this research  are used to select appropriate toxicity tests, to



         document test  results, to develop fate and effects data bases



         where necessary and to provide the modeling means to predict



         toxicity.





Special  Human Data Needs



              To improve the Agency's ability to estimate human risk,  these



         activities examine population  groups exposed to environmental



         contaminants which are suspect toxicants to determine if biological
                                     98

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         indicators  of Hose and/or effects  are  related  to  environmental

         levels of exposure.  Data are also being  developed  on  adverse

         effects as  measured hy traditional  eoidemiological  studies.


Ecology:  Transport/Fate/Field Validation

              To adequately evaluate the likely perturbations  a toxic

         chemical may cause in the environment, it is  necesary  to

         understand probable exposure concentrations and durations,

         movements through ecosystems, degradation rates,  reservoirs,

         effects and residues.  The Agency  must have available techniques

         which may be applied to attain this information,  must  be caoable
                                   /
         of interpreting findings and must  have a  predictive capacity  ^o

         anticipate problems.  Activities in this  area  are desinnpd  to  mpet

         t.hpse needs, to improve the criteria and  standards  with which

         industry, the user?;, nr the Agency must comply.  Thp  int.pnt is to

         provide new or improved state-of-the-art  technigues to fill  data

         gaps in order to take regulatory actions  that  are both scientifically

         credible, and legally defensible.


Health:  Markers, Dosimetry, and Extrapolation

              Health effects research, is focused on development of methodol-

         ogies for the extrapolation of data from  high  to low  doses  and

         between mammalian species, to enhance human health  risk assessment

         predictability.  Additional studies in the toxic substances research

         program involve defining the relationship between biologic  markers

         of exposure and non-cancer health  endpoints such as neurotoxicity

         and immunotoxicity as well as genotoxic endpoints.   Posimetry
                                     99

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         studies are examining dermal  and inhalation routes of exposure.


         Extrapolation research has a  larae pffort dpvoted to gpnpt.ically


         mediated health effects.


Exposure Monitoring


              The major TSCA-related monitoring research efforts are


         currently directed toward improving the monitoring systems


         designed to estimate total human exposure.  Research is also


        .continuing on approaches  for multi-media/multi-pathway monitoring


         systems which generate-data that will  provide an estimate of total


         human exposure.  Epa is also conducting studips to incorporatp


         environmental dose into personal exposure monitors to provide a


         better understanding of the contribution-of diffprent pxposure
                                                       •

         routes to pollutant intake.  The relationship of network monitoring


         to personal exposure monitoring will  be eyalua-ted in-a Human


         Exposure'Assessment- Location Proipct.,



Biotechnology/Microhial and Biochpmical  Ppst Control Agents


              Users of hiotechnological  products must follow recommendpd


         Agency guidelines in a Besting regime designed to help prevent.


         adverse environmental impacts.   EPA's Office of Research and


         Development  (ORn) helps establish these technigues, determines if


         environmental effects are exhibited by previously untested non-


         target organisms, and conducts field-oriented validation studies


         as necessary to ensure that testing criteria and guidelines are


         appropriate and functional.  Engineering research is also underway
                                                                   •

         to develop and/or improve methods to contain or destroy genetically


         engineered organisms.


                                    inn

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              Under TSCA, efforts focus on developing scientific rationales
         and procedures for evaluating the environmental  survivability,
         reproduction, distribution,  effects and risk associated with
         the escape of genetically manipulated organisms.   The results will
         be used to prepare protocols for use in evaluating TSCA products
         involving environmental  application of microbes.   This research
         wi.ll  also support regulatory rulemaking by specifying which products
         are to be considered under TSCA.
              In the health research  area, studies are being conducted to
         determine the genetic stability and function of  a baculovirus
         expression vector in vertebrate cells.  Methods  are also being
         developed to evaluate the potential health consequences of
         deliberate or inadvertent release of genetically  altered organisms.
Engineering Release and Controls
              Under section 5, manufacturers are required  to submit information
         to EPA on both the release and control of new chemical substances,
         and on significant new uses  of designated existing substances.
         EPA uses existing data to predict the risk.s from  the release of
         new substances, and under the existing chemicals  control program,
         evaluates technological  alternatives to reduce the release of and
         exposure to chemicals that are already in use.
              Models are being developed which predict release of and
         exposure to classes of new substances, in order to assess chemical -
         unit operations and processes, and the physical  and chemical
                                    101

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      properties of chemical  substances.   Models  to predict  potential
      exposure and release levels,  as  well  as  the best  control  measures
      to control release of and exposure  to new substances are  also
      being developed.   Treatability testing of potentially  toxic
      chemical.s is also being conducted.
           Alternatives devised to  mitigate the release of and  exposure
      to specific existing and pew  toxic  substances are being defined,
      through the evaluation and adaptation of control  measures related
      to the release of chemicals in the  workplace and  into  the environ-
      ment.  EPA is also evaluating technologies, management, practices,
      and personal protective equipment.to limit  exposure to those toxic
      substances and their release  into the environment.

Ecology:  .Ecotoxicity and Risk Assessment.
           In the. past, the emphasis of ORD's scientific assessment
      program has been  on the assessment  of risk  to human populations.
      However, there is also a need to assess the risk  to non-human
      populations and to the environment.  The development of ecological
      risk assessment methodologies for terrestrial and aquatic ecosystems
      (primarily endangered species and commercial fisheries) is necessary
      to quantify the probability that adverse effects  may occur as a
      result of exposure to a toxic substance, and to estimate the
      significance of such effects  in the environment.   .Since environmental
      data developed by industry may vary greatly from  chemical to
      chemical, procedures need to  be developed which provide guidance
      and consistency for the various environmental exposure activities.
      This work will provide risk assessment protocols, guidelines, and  a
                                 102

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         computerized decision support system for the assessment  of effects
         to terrestrial  and aquatic ecosystems.   This decision  support  system
         will  provide analysts in OTS with information on specific  ecological
         risks and their long-term consequences  to provide the  technical
         foundation for regulations based on probable ecological  damage.

Support
              For certain assessments, the technical  expertise  of the ORD
         staff is required to conduct literature searches, interpret data
         or render technical and scientific judgments due to of the lack
         of data.  In cases where program office evaluations are  complicated
         and/or controversial, independent peer  review of assessments is
         required to ensure consistency.   There  is a  continuing need for
         ORD participation in and review of major.exposure and  hazard
         assessments conducted by OPTS, for supplying Agency policy-makers
         with  technical  assistance from qualified scientists, and for
         improving the scientific basis of Agency decisions in  regulatory
         matters.  Finally, in both the pesticides and toxics areas, support
         will  continue for quality assurance, and the maintenance and
         dissemination of standard reference materials.
              See Appendix H for a summary of FY 1986 accomplishments.
                                    103

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Appendix A



Summary/Guide to Information Required hy Congress

Sections 30, ?R(c) and 9(d) of TSCA require that, certain information he
reported each year to the President and Connress.  To assist readers in
locating this information, a summary of each pertinent TSCA action and
reference to a more detailed explanation found within this report are qiven
here:

Section 3D,  This section contains the basic requirement for the Annual
Report as follows:

(1) Testing.  Tn FY 19fl*, EPA published 17 notices of proposed rulemaking,

    10 proposed t»st standards, 9 notices of final rulemaMnq, and 6 decisions

    not to test (see-Tahlp-4).,.

(?) New Chemical Substance Submissions.  EPA received ?,?13 new chemical

    substance notices f"l,fi93 Premanufacture Noticps, Fifi Test Market Exemption

    Applications, 233 Po'lymer Fxemption Nnticesv and ?31 Low >'.o1ume Exemption

    Notices]' during EY 1Q86, which brought the "trot a T received since .thp.

    proaram's heginninq in mid-1979, to-3,511.  None-of these substances

    were subject to rulemaking under section 4.   In EY 19Pfi, 3? cases

    underwent voluntary testing or control activities, while P7 chemicals

    were subject to the development of either a  section fife) or 5(fl order

    (see Table 1).

(3) Rules Issued under Section 6.  During FY 19«fi, four rules were

    published under section 6.  One action responded to ?? PCR exemption

    petitions (NFR); the other three actions were related to asbestos

    activities (1 ANPR, 1 NPR, 1 NFR) (see Chapter 4, Existinn Chemicals

    for detailed description of PCB and Asbestos accomplishments).
                                 104

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(4). Judicial Actions under T.SCA and Administrative Actions under Section 16.



    Judicial actions involved PCRs, asbestos, dioxins, significant npw use



rules, FPA's testing program under section 4 of TSCA, and section ?1



citizen petitions.



     Ry far, the greatest amount of litigation was on PCRs.  There has hpen



extensive litigation on PCR rulemaking resultina from the 1QPO decision



invalidating FPA's original PCR' rules.  All thp lit.ination involving rule-



making suhseguent to the 19PO decision, however, is likely tn he settled.



Four PCR cases involved situations .where FPA was enforcing its PCP disposal



regulations.  Three PCR enforcement related cases were appeals from penalties



assessed hy FPA; one was resolved in FPA's favor, two have heen recently



filed and are awaiting the setting of a schedule for submitting hripfs.



One PCR enforcement-related case (actually a'consolidation of three cases



involving the same company) was settled when the defendant and FPA anreed



to procedures for cleanup of PCRs.  -Two lawsuits have been filed recently



against FPA's approval  of a PCR disposal  facility in Henderson, Kentucky.



     Three suits are pending attempting to compel FPA to regulate, one with



respect to dioxins, one with respect to asbestos, and one to require tpsting



of certain chemical substances present in the southpast area of Chicaqo.



     A petition for rev'iew was filed with respect to the first sianificant



new use rule under section 5(a)(?); briefing has been stayed pendinq further



rulemaking.



     A petition for review has been filed challenging one of FPA's rules to



require testing under section *(a) Of TSCA.



(5) Ma.jor Problems in Administering the Act.  No major problems were



    encountered in FY 19flfi in administering TSCA.
                                 105

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(6) Recommended Legislation.  Mo leqislative changes are souqht at this



    time.



Section 2fl(c).  This section reouires a report on grants to States durino



the year.  There were no grants administered under TSCA in FY 1QPK.



Grants associated with asbestos were administered under the authority of



the Asbestos School Hazard Abatement Act (ASHAA) (see Chapter A on Fxistinq



Chemicals).



Section 9fd)..  This section requires that FPA's efforts to coordinate its



TSCA activities with related activities of othpr Federal anenries he



reported annually.



     During FY 19Pfi, EPA continued, in several formal and informal agree-



ments with- other Federal government proqrams, to address specific chemical



activities with respect to. the devplopment and implementation of regulations



under TSCA.  One of these continued efforts1 is participation in the Federal



Asbestos Task Force, of which OSHA, CPSC and FPA are charter mpmbers.



Other members include the Food and Drug Administration (FDA), the National



Institute of Occupational Safety and Health (NIOSH), the National Institute



of Environmental Health Sciences (NIEHS), and the National Cancer Institute



(NCI).  In FY 1986, the Plan for the Interaqency Pequlatory Investigation



of Chlorinated Solvents in four ma.ior exposure cateqories was submitted to



the EPA Assistant Administrators and senior manaoement of OSHA, CPSC, and



FDA.  Representatives of the four agencies met in July 19flfi and essentially



approved the Plan.  The Plan calls for submission of options to control



risks associated with metal cleaning and dry cleaninq in December 19P6, and



paint, strippers and aerosols in August 1937.



     Five chemicals were referred to OSHA for regulatory consideration in
                                 lOfi

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FY 1986.  These were:  1,3-butadiene; formaldehyde (apparel  manufacturing);
glycol ethers; methylene bis (2-chlorobenzenamine) (MBOCA);  and toluenediamines.
     Under an interagency agreement with NIOSH, EPA and NIOSH completed selection
of a respiratory strategy for use in PMN review, and developed a final  table of
assigned respiratory factors.  Laboratory work on respiratory protection is
nearly complete; NIOSH will  begin field studies in FY 1987.
     In FY 198(5, the article, "Relation of Survival to other Endpoints  in
Chronic Toxicity Tests with Fish" was published in Environmental Toxicology
and Chemistry.  This was the result of work accomplished between EPA and
the U.S. Fish- and Wildlife Service (FWS).  Also under the interagency
agreement with FWS, a wildlife toxicity handbook was reprinted.
     The Agency continued to participate in FY 1986 on the Working Group
on Biotechnology, established by the Cabinet Council on National Resources
and the Environment.  The group discusses major Federal interagency issues
on biotechnology and develops a coordinated position on them.  Members
include:  Biotechnology Science Coordinating Committee, the Department  of
Agriculture, EPA, FDA, NSF and OSHA.  A joint policy statement was published
in June 1986.  Under an interagency agreement, the Department of Health
and Human Services/National  Institute of Dental Research continued to
provide data and information management support for hazard and risk analysis
of genetically modified organisms.
     Through an interagency agreement, the Agency is working with NIOSH to
better characterize occupational exposure and environmental  release for
acrylates/methacrylates used in radiation-cured applications.  NIOSH is
presently conducting walk-through industrial hygiene surveys to collect
                                 107

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data from approximately a dozen facilities that process and use acrylates
in radiation-cured coatings, inks, and adhesives.   The surveys, along with
NIOSH site reports,.are expected to be completed by March 1987.
     Chemical Advisories are coordinated with other Federal agencies as
appropriate.  For example,'advanced drafts of the Advisories on 2,4-Toluene-
diamines and burning used oil  were reviewed by program management and
technical experts at OSHA, because of the obvious workplace setting of the
hazards covered in these documents.
                                 108

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Appendix B
Major FY 1986 TSCA Actions


                 Description
Section
of Law
Date
4                Procedures Governing Testing Consent Agreements      06/30/86
                 and Test Rules under the Toxic Substances Control
                 Act

4(a)             For listing of testing decisions see Table 4.

4(b)             Test Guidelines Published                            01/06/86
                  -Indirect Photolysis Screening Test

4(f)             Methylene Chloride;  Initiation of Regulatory         10/17/85
                 Investigation (Advance Notice of Proposed
                 Rulemaking)

5(a)(2)          N,N,N'N'-Tetrakis(oxiranylmethy1)-l,3-cyclo-         01/13/86
                 hexane dimethanamine (Proposed Significant New
                 Use Rule)

                 Methyl ammonium- n-methyldithiocarbamate (Proposed    "03/24/86
                 Significant New Use  Rule)

                 Substituted benzenes, halogenated (Proposed          03/18/86
                 Significant New Use  Rule) (2 chemicals)

                 Certain acrylate chemicals (Proposed Significant     04/04/86
                 New Use Rule) (4 chemicals)

                 Benzoic acid, 3,3'-methylenebis [6-amino-, di-2-     05/06/86
                 propenyl ester (Final Significant New Use Rule)

                 Certain alkylsulfonic acids  ammonium salts           06/11/86
                 (Proposed Significant New Use Rule) (2 chemicals)

                 Poly(2-hydroxypropyl)melamine, polymers  with         06/25/86
                 5-isocyanato-l-(isocyanatomethyl)-1,3,3-trimethyl
                 cyclohexane, 2-hydroxyethyl  acrylate-blocked
                 (Proposed Significant New Use Rule)

                 Benzenamine, 3-chloro-2,6-dinitro-N,N-dipropyl-      07/24/86
                 4-(trifluoromethyl)  (Proposed Significant New
                 Use Rule)
                                      109

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5(e)
1-Propanol,  3-mercapto-(Proposed Significant       .  09/12/86
New Use Rule)

Hexachloronorbornadiene (Final  Significant New       11/19/85
Use Rule on  an Existing Chemical)

Hexamethylphosphoramide and Urethane (Final           03/19/86
Significant  New Use Rule on an  Existing
Chemical) (2 chemicals)

Pentach.loroethane (Proposed Significant New Use      03/24/86
Rule on an Existing Chemical)

Methyl ^-butyl ketone (Proposed Significant New      07/07/86
Use Rule on  an Existing Chemical)

PBBs and Tris (Proposed Significant New Use          07/07/86
Rule on an Existing Chemical) (9 chemicals)

11-Aminoundecanoic acid (Proposed Significant        07/22/86
New Use Rule on an Existing Chemical)

Pentachloroethane (Final Significant New Use         09/09/86
Rule on an Existing Chemical)

Significant  New Use Rules; Proposed Amendments       04/22/86-
to General  Provisions and Individual Rules
(Proposed Rule)

Consent Order with Testing Trigger; Substituted      11/20/85
phosphate ester (P85-730) - requires protective
equipment to control worker exposure, and
ecotoxicity  testing.  The Consent Order includes
a testing trigger for a 90-day subchronic study.

Consent Order; Alcohols, Cl-4,  ethers with           12/20/85
polyethylene-polypropylene glycol mono(2-
aminopropyl)ether, polymer with maleic anhydride
and trimethylolpropane triacrylate .(P85-1176) -
requires gloves, goggles and protective equipment
to control  worker exposure pending development
of information.

Consent Order; Substituted aromatic amide (P84-      12/23/85
1136) - requires use of worker protective equipment,
including impervious gloves, safety goggles and
protective clothing.  Training including warning
statements are also required, and MSDS.
                                      110

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Consent Order with Testing Trigger; Substituted      12/24/85
aromatic (P84-954) - requires protective
equipment to control worker exposure, eco-
taxicity testing, and release monitoring.  Consent
Order includes a testing trigger at which
tne Company must submit acute and chronic  eco-
toxicity data.

Consent Order; Isopropylidene-bis-(l,l-dimethyl-  .   12/24/85
propyl) derivative (P85-648) - requires
protective equipment and labeling to control
worker exposure pending development of infor-
mation.

Consent Order; Polymer of: methacrylate -acid;        01/03/86
succinic anhydride; phenol, 4,4'-(l-methylethyli-
dene)bis-polymer with (chloromethyl); 2-methyl-
irnidazole (P85-1014) - requires protective
equipment to control worker exposure pending
development of information.

Consent Order; Silicone ester polyacrylate           01/09/86
(P85-296) - requires protective equipment  to
control worker exposure pending development of
information.

Consent Order; Ami no aery late monomer (P85-298) -    01/09/86
requires protective equipment to control worker
exposure pending development of information.

Consent Order; Substituted pyridine  (P85-36)  -       01/17/86
requires protective equipment and engineering
measures to control worker exposure pending
development of information.

Consent Order; Haloalkyl substituted cyclic ether    01/17/86
(P85-367/368) - requires protective equipment to
control worker exposure pending development of
information.

Consent Order; Haloalkyl substituted cyclic ether    01/17/86
(P85-369) - requires protective equipment  and
respirators to control worker exposure pending
development of information.

Consent Order; Substituted pyridine  (P85-706) -      01/17/86
requires protective equipment to control worker
exposure pending development of information.

Consent Order; Functionally modified urethane
(P85-1063) - requires protective equipment to        01/17/86
control worker exposure pending development
of information.
                     Ill

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Consent Order; Polyester polyurethane                01/17/86
(P85-1068) - requires protective equipment to
control worker exposure pending development
of information.

Consent Order with Testing Trigger; Disubstituted    01/24/86
alkyltriazine (P85-932/933) - requires protective
equipment and respirators to control worker
exposure.  The Consent Order includes a testing
trigger for a 28-day oral subchronic study.

Consent Order; Cycloaliphatic epoxide                01/30/86
(P84-1137) - requires protective equipment to
control worker exposure pending development of
information.

Consent Order; 1,1-Oimethylpropyl  peroxyester        01/31/86
(P85-680) - requires protective equipment to
control worker exposure pending development
of information.

Consent Order with Testing Trigger; Polypropylene    02/10/86
glycol alkyl ether (P85-390/891/892) - requires
protective clothing to control  worker exposure.
The Consent Order includes a testing trig-ger for
a .90-day subchronic study..

Consent Order; Kel acrylate complex (P85-1XJ34) -     02./13/86
requires gloves to control worker exposure-
pending development of information.

Consent Order with Testing Trigger; Disubstituted    03/05/86
sulfide (P85-234) - requires a  production volume
trigger, at which the Company must submit
28-day subchronic and sister chromatid exchange
studies.

Consent Order; Ester-modified epoxy resin            03/06/86
(P85-1380) - requires protective clothing to
control worker exposure pending development of
information.

Consent Order; Halogenated alkene (P85-1167) -       03/07/86
requires protective equipment and respirators
to control worker exposure pending develop-
ment of information.
                         112

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Consent Order with Testing Trigger; Polymer of       03/17/86
an aerylate ester and mixed methacrylate esters
(P85-1283) - requires protective equipment to
control worker exposure.  The Consent Order
includes a testing trigger for a 90-day oral
subchronic study.

Consent Order; Omega-functional esterified hydroxy   03/17/86
methacrylate (P85-1302) - requires protective equip-
ment to control worker exposure pending development
of information.

Consent Order; Functional polyurethane from poly-    03/17/86
alkylene oxide, aliphatic diisocyanate and
substituted alkanol (P85-1318) - requires protective
equipment to control worker exposure pending
development of information.

Consent Order; Substituted amino anthraquinones      03/20/86
(P85-18) - requires protective equipment to control
worker "exposure pending development of information.

Consent Order; Capralactone modified by              03/25/86
hydroxyethyl methacrylate (P86-164) -
requires protective clothing to control worker
exposure pending development of information.

Consent Order; Aliphatic diurethane acrylate         04/01/86
ester  (P85-1013) - requires protective equipment,
clothing, and respirators to control worker
exposure pending development of information.

Consent Order; Unsaturated acid and heterocyclic     04/01/86
modified epoxy resin (P85-1425) - requires
protective equipment, clothing, and respirators
to control worker exposure pending development
of information.

Consent Order with Testing Trigger; Benzoic acid,    04/03/86
2-((3A,4,5,6,7,7A-hexahydro-5(or 6) methoxy-
4,7-methanoindan)-methyidene)amino, methyl ester
(P85-1210) - requires a production volume trigger
at which time the Company must submit acute
ecotoxicity studies.

Consent Order with Testing Trigger, Benzoic acid,    04/03/86
2-(3-phenyl,butylidene)amino, methyl ester (P85-
1211)  - requires a production vo.lume trigger at
which  time the Company must submit acute toxicity
studies.
                  113

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Consent Order with Testing Trigger; Benzoic acid,    04/03/86
2-(3-(4-methyl,cyc1ohex-3-enyl)butylidene)amino,
methyl ester (P85-1212) - requires a production
volume trigger at which time the Company must
submit acute toxicity studies.

Consent Order;  Substituted alky! alkanol (P85-       04/05/86
822) - requires protective equipment to control
worker exposure pending development of information.

Consent Order;  Substituted pyridine (P84-1219.) -     04/09/86
requires protective clothing respirators and
gloves to control worker exposure pending
development of information.

Consent Order;  3-Chloro-2,6-dinitro-N,N-dipropyl-    04/09/86
4-(trifluoromethyl)-benzenamine (P86-83) - requires
protective equipment and clothing to control worker
exposure pending development of information.

Consent Order;- Acid modified acrylated epoxide       04/11/86-
(P85-1169) - requires gloves, goggles, protective
clothing, and respirators to control worker
exposure pending development of information.

Consent Order;  Acid modified acrylated ha-logenated   04/11/86
epoxide (P85-1170) - requires gloves, goggles,
protective clothing, and respirators, to control
worker exposure pending development of information.

Consent Order with Testing Trigger; Sodium salt      04/28/.86
of an alkylated, sulfonated aromatic (P84-591) -
requires a production volume trigger, at which
time the Company must submit chronic ecotoxicity
testing.

Consent Order;  Tert-amyl peroxy alkylene ester       05/23/86
(P85-1180) - requires protective clothing and gloves
to control worker exposure pending development of
information.

Consent Order;  Polymeric aliphatic polyol            06/05/86
acrylate ester (P85-159/160/161/162) - requires
gloves, goggles, protective clothing, and res-
pirators to control  worker exposure pending
development of information.

Consent Order;  Substituted acrylated alkoxylated     06/09/86
aliphatic polyol (P86-346) - requires protective
equipment to control worker exposure pending
development of information.
                      114

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Consent Order; Substituted alkyl aniline (P85-       06/13/86
1420) - requires protective equipment, clothing,
and respirators to control worker exposure pending
development of information.

Consent Order; Substituted pyridine (P85-236) -      06/15/86
requires protective equipment, clothing, and
respirators to control worker exposure pending
development of information.

Consent Order with Testing Trigger; 1-Propanol,      06/16/86
3-mercapto- (P85-433) - requires protective
equipment, clothing, and respirators to control
worker exposure.  The Consent Order includes a
testing trigger for a developmental toxicity
study.

Consent Order with Testing Trigger; Ethenyl silane   07/11/86
ester (P85-1369) - requires 90-day subchronic test
after reaching specified aggregate production
volume.

Consent Order; Modified acrylic ester (P86-387) -    07/11/86
requires worker protective clothing and use of a
NIOSH-approved respirator, plus warning statements
and MSDS.

Consent Order; N-Nitrosophenylhydroxylamine,         07/24/86
ethanolamine salt (P86-542) - requires worker
protective clothing, warning statements and MSDS.

Consent Order with Testing Trigger; Benzothiazole-   08/12/86
sulfonic acid, substituted-((substituted-pyrimidinyl)
azo)carbamonocycle-, alkali metal salt (P85-994) -
requires use of worker protective equipment during
manufacturing and processing.
Consent Order with Testing Trigger; Alkyl(hetero-
cyclicylJphenylazo-heteromonocyclicpolyone (85-
1370) - requires standard development toxicity test
in two mammalian species after reaching aggregate
combined production volume of the PMN substance.

Consent Order with Testing Trigger; Alkyl unsub-
stituted spiro heterocyclic (P86-136) - requires use
of worker protective equipment during manufacturing
and processing.
     08/12/86
     08/12/86
Consent Order with Testing Trigger; Triglycidyl
ether of substituted tri(hydroxyphenylJmethane
(P85-854/855) - requires 90-day subchronic test
one species after reaching specified production
volume.
     08/15/86
in
                      115

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Consent Order with Testing Trigger; Triglycidyl ether    08/15/86
of a substituted tri(hydroxyphenyl) methane (P85-973) -
requires 90-day subchronic test in one species after
reaching specified production volume.

Consent Order with Testing Trigger; Modified tris-       08/15/86
phenol epoxy novolac (P86-382) - requires use of
worker protective equipment, including impervious
gloves, safety goggles and protective clothing.
Training and warning statements are also required,
and MSDS.

Consent Order with Testing Trigger; 1,3,5-Triazine-      08/19/86
2,4,6(lh,3h,5h)-trione, l,3,5-tris(2,3-dibromo-
propyl) (P84-900) - requires worker protective
equipment, use of approved respirator, warning,
labelling.  Production volume trigger requires 2-
generation reproduction study.

Consent Order with Testing Trigger; Methyltris           08/25/86
(1-methylethyl )benzene (P86"-124) - requi res" two-
tiered testing after reaching specified aggregate pro-
duction volume.  Tier 1 test requirements are acute and
chronic aquatic studies.  Tier 2 requires 90-day oral
subchronic and a fish bioconcentration test.  Requires
worker protect!v-e equipment, including protective
clothing-and respirators; and. restrict.ron of releases
to approved sites.      •  '  .

Consent Order; Poly(oxy~l,2-ethaned1yl),alpha(l-oxo-     09/08/86
2-propenyl)omega-(dodecyloxy)- (P86-554) - requires
protective equipment, notification, labelling and MSDS.

Consent Order; Poly(oxy-l,2-ethanediyl),A-(2-methyl-l-   09/08/86
oxo-2-propenyl)-w-(dodecyloxy)- (P86-588) - requires pro-
tective equipment, notification, labelling and MSDS.

Consent Order; Methacrylic ester (P86-650) - requires    09/25/86
worker protective equipment, MSDS and labelling.

Unilateral Action; vinyl chloride - vinyl acetate        04/22/86
hydroxyl modified copolymer (P85-1388) - bans chemical
to control worker exposure.  Unable to address health
concerns without additional data.
                             116

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5(h)(3)
6(e)

8(a)
8(b)
Revisions of Premanufacture Notification             04/22/86
Regulations (Final Rule)

Asbestos; Proposed Mining and Import Restrictions    01/29/86
and Proposed Manufacturing, Importation and
Processing Prohibitions (Proposed Rule)

Asbestos Abatement Projects (Final  Rule)             04/25/86

Asbestos-Containing Materials in Schools; Inspec-    08/12/86
tion, Notification, Management Plans, and Technical
Assistance (Advance Notice of Proposed Rulemaking)

Response to Exemption Petitions (PCBs) (Final  Rule)   08/08/86

Partial Updating of TSCA Inventory Data Base;         06/12/86
Production and Site Reports (Final  Rule)

Anthraquinone Reporting and Recordkeeping Require-   11/06/85
ments (Proposed Rule)

P-Tert-Butylbenzoic Acid, P-Tert-Butyltoluene,       11/07/85
P-Tertr-Butylbenzaldehyde; Reporting and Record-
keeping Requirements (Proposed Rule)

Hexachloronorbornadiene; Submission of Notice  of     11/19/85
Manufacture, Import, or Processing (and Deter-
mination of Significant New Use)

Additiorrof 17th ITC Report Chemicals to the         11/19/85
Section 8(a) Preliminary Assessment Information
Rule (Final Rule)

Polyhalogenated Dibenzo-p-dioxins/Dibenzofurans;     12/19/85
Reporting Requirements (Proposed Rule)

4,4'-Methylenebis(2-Chloroaniline); Reporting  and    04/18/86
Recordkeeping Requirements (Final  Rule)

P-Tert-Butylbenzoic Acid, P-Tert-Butyltoluene,       05/12/86
P-Tert-Butylbenzaldehyde; Reporting and
Recordkeeping Requirements (Final  Rule)

Addition of 18th ITC Report Chemical to the          05/19/86
Section 8(a) Preliminary Assessment Information
Rule (Final Rule)

11-Aminoundecanoic Acid; Recordkeeping Requirements   07/22/86
(Proposed Rule)

Chemical Assessment Information Rule (Proposed       10/07/86
Rule)

Chemical Substances Inventory; Removal of 104         10/11/85
Incorrectly Reported Chemical Substances from  the
TSCA Inventory
                                      117

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8(c)
8(d)
9(a)
9(d)
Records and Reports of Allegations of Significant    11/13/85
Adverse Reactions to Health or the Environment
(Final  Rule)

Health and Safety Data Reporting; Urea-Formaldehyde  11/07/85
Resins (Final Rule)

P-Tert-Butylbenzoic Acid, P-Tert-Butyltoluene,       11/07/85
P-Tert-Butylbenzaldehyde; Health and Safety Data
Reporting Rule (Proposed Rule)

Addition of 17th ITC Report Chemicals to the         11/19/85
Section 8(d| Health and Safety Data Reporting Rule
(Final  Rule)

Polyhalogenated Dibenzo-p-dioxins/Dibenzofurans;     12/19/85
Reporting Requirements (Proposed Rule)

Submissions of Lists and Copies of Health and        12/27/85
Safety Studies on Vinyl Acetate (Final Rule)

Health and Safety Data Reporting; Hexachlorocyclo-   01/09/86
pentadiene (Final Rule)

Submission of Lists and Copies of Health 'and Safety  01/22/86
Studies on Certain Substances Subject to the 1984
RCRA Amendments  (Final Rule)

P-Tert-8utylbenzoic Acid, P-Tert-Butyltoluene,       05/12/86
P-Tert-Butylbenzaldehyde; Health and Safety Data
Reporting Rule (Final Rule)

Addition of 18th ITC Report chemical to the Section  05/19/86
8(d) Health and Safety Data Reporting Rule (Final
Rule)

Health and Safety Data Reporting; Submission of      08/01/86
Lists and Copies of Health and Safety Studies on
Certain Substances  (Proposed Rule)

Health and Safety Data Reporting Submission of       09/15/86
Lists and Copies (Final Rule)

1,3-Butadiene; Decision to Report to the             10/10/85
Occupational Safety and Health Administration

2-Methoxyethanol, 2-Ethoxyethanol and Their          05/20/86
Acetates; Referral for Additional Action

Formaldehyde; Termination of Regulatory Investi-     03/19/86
gation Concerned with Occupational Exposure

4,4'-Methylene Bis(2-Chloroaniline); Termination of  06/23/86
Regulatory Investigation
                                      118

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                 To!uenediamines; Termination of Regulatory           07/22/86
                 Investigation Concerned with Occupational  Exposure

21               Guidance for Petitioning the EPA under Section 21    11/13/85
                 of TSCA

26(b)            Toxic and Hazardous Substances; Premanufacture       07/11/86
                 Notice Fees

                 CHEMICAL ADVISORIES

                 Burning Used Oil                                        11/86
                 Toluenediamines                                         09/86
                                          119

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Appendix C
               Chemical  Hazard Information Profiles (CHIPs)

                Acrylic  Acid 2
                Brominated Diphenyl  Ethers (12 chemicals)
                C.I. Basic Red 9 Monohydrochloride
                Chlorendic Acid/Anhydride (2 chemicals)
                Chlorinated Styrenes (9 chemicals)
                Chlorobromoethane
                Diisopropyl Sulfate
                Hexaf1uoroi sobutylene
                Nitropropane 2
                Organosilanes (22 chemicals)
Appendix D
                        Substitute. Hazard Profiles.

                       Triethanolamine
                       N ,N' -Methyl enebi sacry 1-ami de
                       Ammonium Persulfate
                       Carbon (fibers)
                       Wollastonite
                       Ethanol
                       Methanol
                       Isopropanol
                       Acetone
                       1-Butanol
                       Kerosene
                       Mineral Spirits
                       Stoddard Solvent
                       Cure-Rite 18
                       Tetrachlorophthalic Anhydride
                       Dibromoneopentyl Glycol
                       Tetrabromophthalic Anhydride
                                  120

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Appendix E
                    Section 4 Test Studies* Received
Aryl phosphates (2 studies)
Propylene oxide
Tri s(2-ethylhexyl)trimel1itate
   (7 studies)
Hydroquinone (7 studies)
1,3-Dfoxolane
Antimony trioxide (3 studies)
2-Chlorotoluene (3 studies)
Di(2-ethylhexyl)terephthalate
D1(2-ethylhexyljphthalate (2 studies)
Chlorotoluene  (mixture)
Cyclohexanone  (7 studies)
Di-(n-heptyl, nonyl, n-octyl undecyl)
  phthalate (2 studies)
Di-isodecyl phthalate (4 studies)
D'i-undecyl phthalate (4 studies)
Vinylidene fluoride
Trichloroethane
2-Mercaptobenzot:hi azol e
2-Mercaptobenzot:hiazole disu] fide

*97 studies on 24 chemicals
   Di-methyl phthalate (2 studies)
   Di-n-butyl  phthalate (3 studies)
   Di-(n-hexyl, n-octyl, n-decyl)
     phthalate (3 studies)
   Di-isononyl phthalate (4 studies)
   o-Phenylenediamines (4 studies)
   m-Phenylenediamines (5 studies)
   p-Phenylenediamines (5 studies)
   Butyl  benzyl phthalate (6 studies)
   2-Ethylhexanol
   Mono-2-ethylhexyl phthalate
   Bis(2-ethylhexyl jtrlmellitate
     (7 studies)
   Hexafluoropropylene oxide
   Acrylamide
   Di-(2-ethylhexyl)adipate
   Di-(n-heptyl ,  n-nonyl, n-undecyl)
     phthalate (2 studies)
   .Acrylamide monomer (2 studies)
Appendix F
                               NTP Studies
           National Toxicology Program (NTP) Studies Reviewed

            l-Chloro-2-methylpropene (Dimethylvinyl Chloride)
            Ampicillin trihydrate
            Chloropheniramine maleate
            Oxytetracycline hydrochloride
            Methyl methacrylate
            1,1,2-Tri chloroethylene
            Decabromodiphenyl oxide
            Chlorendic acid
            Pentachloronitrobenzene
            Boric acid
            1,4-Dichlorobenzene
            Tetra kis(hydroxymethyl)
            Tetra kis(hydroxymethyl)
            PhenyTephrene hydrochloride
            Mixed xylenes
            Rotenone
            Dimethyl methylphosphonate
            Methyl carbamate
            Bromodichloromethane
            Ethylene oxide
phosphonium chloride
phosphonium sulfate
                                       121

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Appendix G
Date
Filed
                 FY 1986 Section 21 Citizens' Petitions
Who
Filed
Action Requested
   EPA's
Disposition
  Date of
Disposition
3/7/86
Chemical
Waste
Management
That EPA amend its
PCB disposal regula-
tions to clarify
that materials at
the Model City
facility may be
legally landfilled
  withdrawn
   06/13/86
11/20/85
Citizens for
Healthy
Progress
12/09/85  Valley Watch
04/29/86
08/18/86
Chemical
Manufacturers
Association
Standard
Chlorine
Chemical
Co., Inc.
That EPA halt the
construction of a
PCB disposal
facil-ity planned for
Henderson, KY

That EPA issue
either a "proposed
order" under section
5(e), or.an injunction
prohibiting, the
construction of
the Henderson
facility

That EPA reconsider
and withdraw Phase 1
test rule for
mesityl  oxide

That EPA reconsider
the.test require-
ment for 1,2,4,5-
tetrachlorobenzene
  denial
                                     denial
  denial
   02/24/86
  (51FR6423)
                    02/24/86
                   (51FR6423)
                                                                 08/25/86
                                                                (51FR30216)
  pending
  as of 9/30/86
                                       122

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Appendix H
                Summary of Research and Development Activities

                           FY 1986 Accomplishments


A.  TEST METHOD DEVELOPMENT

    ENVIRONMENTAL PROCESSES

    o  Report on techniques for effects and update of sediment-associated
       toxic chemicals by Benthic Marine Species.  06/86

    o  Report on the Fathead minnow as a surrogate for other aquatic species.
       07/86

    o  Report on use of relative, position-specific efficiency measurement of
       benzo(a)pyrene metabolism as field indicators of carcinogenicity stress
       aquatic environment.  09/86

    HEALTH

    o  Complete development of two immunotoxicity assays in an-imals.  09/86

    o  Journal article on growth enhancement of human bronchial epithelial
       cells by nickel sulfate.  09/86

    o  Journal article on the use of a renal concentration test in the
       neonate as a predictor of long-term alterations. in urogenital
       morphology.  09/86


B.  HEALTH:  MAiRKERS. DOSIMETRY, EXTRAPOLATION

    o  Predictive models for dose effects of asbestiform minerals.  09/86

    o  Journal article on the review and analysis of the literature of
       select chemicals and the establishment of the gene-tox data base.
       07/86

    o  Journal article on metabolism of benzo(a)pyrene in monolayer cultures
       of human bronchial epithelial cells from a series of donors.  03/86

    o  Journal article on interspecies comparison of adult to developmental
       toxicity ratios.  08/86


C.  SPECIAL HUMAN DATA NEEDS

    o  Proceedings of conference on medical screening and monitoring for
       effects of chemical exposure in the workplace.  09/86
                                      123

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D.  ECOLOGY:  TRANSPORT, FATE AND FIELD VALIDATION

    ENVIRONMENTAL PROCESSES

    o  Journal article on environmental factors governing the kinetics of
       abiotic reduction transformation.  12/85

    o  Journal article on light-induced oxidation of pollutants involving
       natural inorganic species.  12/85

    o  Progress report on evaluation of Leffler & Taub microcosms for
       screening chemicals.  01/86

    o  Report on the influence of scale in marine microcosms perturbed by
       toxic chemicals derived from laboratory microcosms.  03/86

    o  Journal article on exposure study of organics in Delaware River using
       TOXIWASP.  04/86

    o  Journal article on SAR at the ecosystem levels single:  species
       relative toxicity vs. ecosystem level toxicity using microcosms.  08/86

    o  Report on suitability of biodegradation information from fate screen
       tests for predicting fate of toxic organic compounds in microcosms and'
       field studies..  09/86

E.  ENGINEERING-

    o  Preliminary assessment of predictive techniques for extraction,.
       flaking, and agglomeration unit operations.  01/86

    o  Evaluations of procedures and methodology of asbestos abatement.
       03/86

F.  EXPOSURE MONITORING

    o  Interim report on pollutant sources and human exposure to toxic
       pollutants using TEAM Data - FY 86.  12/85

G.  STRUCTURE-ACTIVITY RELATIONSHIPS

    HEALTH

    o  Report on how to use molecular electrostatic potential to make risk
       assessments on chemically induced toxicity for one class of chemicals.
       09/86

    o  Report on SAR studies on azoreductase II.  09/86
                                      124

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    ENVIRONMENTAL PROCESSES

    o  Report on a comprehensive structure-toxicity method to estimate toxicity
       of chemicals to aquatic organisms.  03/86

    o  Report on SAR methods to predict major metabolites of industrial
       chemicals.  08/86

    o  Report on SAR identification of.potential tumorogenic industrial
       chemicals.  09/86

    o  Journal article describing relationships between microbial degradation
       rate constants and chemical properties.  09/86

H.  BIOTECHNOLOGY

    ENVIRONMENTAL PROCESSES

    o  Report on data base for detecting, identifying, and enumerating novel
       organisms in terrestrial environments.  01/86

    o  Report on development of data base assessing genetic stability of
       novel organisms.  02/86

    ECOLOGY:  ECOTOXICITY AND-  RISK ASSESSMENT

    ENVIRONMENTAL.PROCESSES

    o  Journal article on model developed to describe exchange of non-polar
       hydrophobic toxicants across fish gills.  08/86

    o  Computer program of gill exchange model for predicting bioaccumulation
       of hydrophobic xenobiotic chemicals.  09/86

J.  SUPPORT

    MONITORING

    o  Guidelines for field testing soil, date, and transport models - Final
       report.  04/86

    o  Report on Asbestos Audit Program.  09/86

    ENVIRONMENTAL PROCESSES

    0  Final report on chronic toxicity of phthalate esters to Daphnia
       and Fathead minnows.  03/86
                                      125

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