ENVIRONMENTAL
     PROTECTION
          AGENCY
TOXIC SUBSTANCES, PESTICIDES
   FISCAL YEAR 1980
     ZBB BUDGET
sntal Protection Agency
               Dea/i'-'! n Street,
                6OJQ1
      OMB SUBMISSION FOR OFFICIAL USE ONLY

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            TOXIC SUBSTANCES  MEDIA
                                             100R80005
                   CONTENTS


                                         PAGE

A.   MEDIA RESOURCE  SUMMARY	       1

B.   MEDIA OVERVIEW	       2

C.   MEDIA RANKING	      10

D.   BUDGET REQUEST  BY  DECISION  UNIT      13

E.   DECISION UNIT DESCRIPTIONS  AND
     LEVELS

          RESEARCH AND  DEVELOPMENT...      17

          ABATEMENT  AND CONTROL	      83

          ENFORCEMENT	     149

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                 ENVIRONMENTAL PROTECTION AGENCY

                       FY 1980 OMB REQUEST

                        Toxic Substances
                     Media Resource Summary
                             FY 1979            FY  1980           Change
                                     (dollars  in thousands)
Research & Development
Permanent Positions	     59                163             +104
Budget Authority	15,279.6          50,284.9        +35,005.3

Abatement & Control

Permanent Positions	    425                642             +217
Budget Authority	41,557.0          75,561.1        +34,004.1

Enforcement

Permanent Positions	     70                 78               +8
Budget Authority	  3.233.2	3.805.6	+572.4

Total

Permanent Positions	    554                883             +329
Budget Authority	60,069.8         129,651.6        +69,581.8
                                                                       OOC1

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                     TOXIC SUBSTANCES MEDIA OVERVIEW
  I.    OVERVIEW AND STRATEGY

       The  Toxic  Substances Control Act  (TSCA) establishes a program with
  the  objectives  of insuring that adequate data are developed with respect
  to the  effects  of chemical substances  and mixtures on health and the en-
  vironment and that those chemicals which present an unreasonable risk of
  injury  to health or the environment are regulated to reduce that risk.
  The  Act's coverage is broad, encompassing as many as 70,000 chemicals
  currently in commerce with up to 1,000 additional new chemicals intro-
  duced each year.  About 115,000 manufacturers and processors are subject
  to the  Act.

       The  major  programs EPA must develop and implement to carry out the
  provisions of the Act are those to:  (a) require testing of chemicals
  and  submission  of reports of existing  information by industry and review
  these and other data to determine chemical hazards; (b) review and act
  on new  chemical and significant new use notifications by industry and
  control the manufacturing, processing, distribution, use, and disposal
  of existing chemicals that pose unreasonable risks to health and the
  environment; (c) enforce these statutory and regulatory programs, and
  (d)  conduct research and development to support the implementation of
  the  law.

      There was  a limited organizational and conceptual base upon which
  to build  the toxic substances program  when the law was first enacted.
  Consequently, the first years of implementation have had the develop-
  ment of the foundations for program operation as the major accomplish-
  ment.   We have  established and begun staffing the organization to carry
  out  the program.  At the same time we  have arrived at the initial ap-
  proaches  to many basic program functions and have taken selected actions
  where warranted.

      Some of the major base programs that we have begun to put in place
  include a hierarchical scheme of test  standards and its use for chemical
  test regulations; a three-stage assessment process for reviewing suspect
  chemicals to determine potential risks; the first control regulations on
  chemicals posing unreasonable risks; the premanufacture review program
  with the  initial regulations, forms, and other supporting documents; basic
  data management facilities and operations; approaches for using reporting
  requirements for information gathering and mechanisms for setting prior-
  ities for action; enforcement policies and procedures for inspections,
  hearings, penalties, emergency actions, and imports; reorientation of ex-
  isting  research to toxic substances; and a basic plan for toxic substances
  research.
0002

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     Many of these foundation-building elements will continue into the
next years, with an evolution of these basic program approaches and more
extensive implementation of them, resulting in an appreciable increase
in associated outputs (i.e., chemical control regulations, test stand-
ards, reporting requirements, etc.).  Of course, staffing and organiza-
tion, particularly of required scientific skills, will remain a key
element in this beginning operational phase.

     The Fiscal Year 1979 and 1980 programs will reflect this move into
operation for most program areas, but to varying degrees.  Many elements
of the toxic substances program are interrelated and their implementation
must be carefully balanced and staged.  In order for the overall program
to continue operation in future years, certain long lead time activities
must be started at a high level.  The time required successively to imple-
ment testing requirements, have industry develop the data, evaluate the
potential hazards, and take appropriate control action for particular
chemicals may extend over saveral years.  In addition, the program has
presently been operating on an established information base carried over
from previous years.  This backlog of information will be rapidly used up
and will have to be replenished.  For these reasons, the testing and eval-
uation of chemicals continue to receive greater emphasis in order to es-
tablish an adequate information and assessment base upon which to take
actions now and in the future under TSCA and other toxics-related programs.

     Another key operational program will be the review of industry noti-
fications before the manufacturing of new chemicals in order to assess
their risks and take appropriate action.  Premanufacture review will begin
during Fiscal Year 1979 and will be fully operational in Fiscal Year 1980.
Much of the effort required by this program will be a function of factors
outside of the Agency's control.  The nature of this program as one of the
Agency's major preventive health programs necessitates that adequate empha-
sis be placed on it to insure protection from risks before they are posed—
possibly at the expense of other programs if the level of these activities
exceeds current expectation.

     Control actions will be taken on a selected number of chemicals ex-
pected to be identified in these first years of operation as posing un-
reasonable risks.   Nonregulatory approaches, such as information dissemina-
tion and informal discussion, will also be used when appropriate to effect
protection from potential risks.  Adequate economic analysis, information
planning and reporting,  information systems and services, and monitoring
support will be provided to these high priority programs.  The implementa-
tion and operation of information systems enabling us to enter, sort, and
retrieve available data; track submissions; refer to data sources in other
systems; and conduct analyses will be emphasized to improve the program's
efficiency and effectiveness.  The program will rely extensively in all
areas on other programs and agencies to take action when appropriate, and
to establish coordinated approaches to problems, as the Act requires.
                                                                     0003

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      Enforcement of Toxic Substances Control  Act  regulations  will  empha-
 size inspection and compliance monitoring  programs,  and  appropriate en-
 forcement action related to the control regulations  which are in place
 and emergencies which may occur.  Limited  enforcement  of other provisions,
 such as testing, premanufacturing review and  reporting requirements,  will
 be undertaken.

      EPA, in conjunction with other Federal regulatory agencies, will
 undertake a major new research initiative  to  accelerate  the development and
 validation of short-term toxicological tests, both to  improve the  speed
 and accuracy of toxicological screening in order  to  protect public health
 and to reduce the economic impact on the industrial  sector.  Special emphasis
 will be placed on screening tests for neurotoxicology  and behavioral toxi-
 cology, where there is little work underway.   In  addition, one of  the most
 important tools that the Agency should have at its disposal is the capa-
 bility to detect early signs of public health threats.  An improved under-
 standing of how hazardous chemicals affect humans and  how these effects
 are indicated before the disease state becomes irreversible must underlie
 such a capability.  Needed activities include a compilation of known clin-
 ical indicators of toxicity; identification of new clinical indicators;
 and development and testing of monitoring  schemes to detect such indica-
 tors early.  This effort will be of immediate importance in limiting
 dangerous occupational exposures and will  likely  become  critical in limit-
 ing general environmental exposure.

      Other research and development undertaken as part of EPA's coordinated
 approach to dealing with toxic substances  with other Federal  regulatory
 agencies will focus upon the issue of total exposure to  and the body burden
 of toxic substances considered for regulation. This will be  particularly
 acute as the threat of multiple toxicants  is  dealt with  in regulations.

      Determining human exposure to toxic substances  requires  an improved
 understanding of how toxic chemicals interact in  and move through  the
 environment.  Our research will identify quantitative  measures of  such
 factors as rates of deposition and reactions  in sediments, bioaccumula-
 tion, and degradation products, that are typically the critical information
 missing in most exposure assessments.  We  are also proposing  to develop
 ecosystem models to use in making such estimates  and to  validate these
 models using natural ecosystems.

 II.  RANKING CRITERIA AND PRIORITIES

      The basic criteria used to rank decision unit levels for the  toxic
 substances program are as follows:

        •  The expressed line managers' priorities which  are:

           Abatement and Control—completing control actions
           on unreasonable risks already identified;  completing
           assessments of and initiating control on new chemical
           risks; initiating information gathering through
OOIA

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          testing and reporting, and front-end assessment for a large
          number of chemicals now in order to support future program
          activities; and providing adequate support functions which
          are required for these activities.

          Enforcement—taking appropriate enforcement action on toxics
          emergencies; strongly enforcing existing control regulations;
          enforcing other provisions such as testing, new chemical
          notification and reporting requirements to a more limited
          extent.

          Research and Development—providing scientific assistance to
          TSCA implementation; developing testing methods and protocols;
          developing tools for assessment; supporting control actions.

        •  Health and environmental impacts.  Health-related activities
          are given priority.  Emphasis is given to environmental con-
          cerns as well because the law also requires protection against
          unreasonable risks to the environment.

        »  Programmatic consistency.  Interrelated programs are ranked
          together.

        •  Statutory requirements.  Mandated activities (e.g., processing
          new chemical notifications) are given high priority.

        •  Short-term versus long-term impact.  Short-term impacts are
          emphasized at the lowest funding levels, however, the overall
          ranking balances immediate outputs and long-term activities
          which impact the future program.

        •  Cost-effectiveness.  The greatest amount of program impact
          from the resources provided is stressed.  The provision of
          quantifiable outputs is emphasized.

III. FY 1980 PROGRAM HIGHLIGHTS

     The Fiscal Year 1980 program evolves directly from the base estab-
lished in the Fiscal Year 1979 program, with the emphases described in
the overview and strategy.  Testing and evaluation of chemicals continue
to receive greater emphasis in order to establish an adequate information
and assessment base for future actions.  Premanufacture review of new
chemicals as a major preventive health program will become fully opera-
tional.  Control actions will be taken on chemicals identified as posing
unreasonable risks.  Adequate information, monitoring, and other required
support to these activities will be provided.

     Major enforcement activities include design and implementation of
inspection and compliance monitoring programs to detect TSCA violations;
development and exercise of appropriate enforcement remedies upon
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 detection of violations;  negotiation  and  establishment  of  cooperative
 enforcement agreements with selected  States;  and  assistance  in  the
 development of future  TSCA regulations  that can be effectively  enforced.
 In  Fiscal Year 1980, these activities will continue  to  focus primarily
 on  existing chemical control regulations.  However,  the advancing
 maturity of TSCA implementation will  require  increasing enforcement
 efforts in additional  areas.   In Fiscal Year  1980 and succeeding years,
 the resource commitment to enforcement  of chemical testing, new chemical
 notification,  chemical information  reporting, and export/import require-
 ments will grow.

      The Toxic Substances Control Act of  1976 requires  the Agency to
 develop human and environmental risk  assessment procedures and  testing
 protocols for toxic chemicals.  The proposed  Fiscal  Year 1980 research
 and development program will provide  for  the  development of methods for
 determining subtle effects on the reproductive and immune  systems,
 epidemiological evaluations of exposed populations,  and long-term and
 short-term tests for the  carcinogenic,  teratogenic,  neurotoxic, and
 mutagenic effects of substances.  The program will also include exposure-
 assessment models and  testing protocols based on  transport and  fate
 research to-be used in risk estimation  for a  few  classes of  toxic
 chemicals.   During Fiscal Year 1979 the Agency will  carry  out necessary
 research in the area of transport and fate in order  to  understand the
 development of exposure assessment  technology.

      We are also conducting research  to provide calibrated protocols for
 testing environmental  hazards of toxic  chemicals  in  support of  sections
 10(c)  and 10(e)  of the Toxic Substances Control Act.  Sixteen test
 methods will be calibrated and seven  will be  published.  The calibrated
 methods include freshwater fish and marine fish chronic, ethylene stress,
 mysid chronic, embryo  larval daphnia  chronic, and marine polychaete.
 These test methods will then be incorporated  into test  standards under
 the test regulations provisions of  the Act.

      The research program will provide  improved methods for measuring,
 identifying,  collecting,  and separating selected  toxic  chemicals in the
 air,  and, to a limited extent, in water and sediments.  This area of
 the research program will also provide data on exposure levels  of toxic
 chemicals to be used in risk assessment and validation  of  exposure
 models.

      The research program also includes aerial photography of industrial
 sites and ambient monitoring of manufacturer/user sites.   There will be
 retrospective photointerpretative analysis of demographic  alteration
 coincident with industrial development  at about ten  sites  and monitoring
 of  ambient air at 20 chemical manufacturing sites for stray emissions of
 toxic chemicals.   Samples of soil and water flora/fauna will be analyzed
 for classes of toxic chemicals at several sites to make environmental
 assessments of the impact from the  sites.
0006

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IV.  REQUEST SUMMARY

                                FY 1980 Total     Changes from FY 1979

                                PFT  BA $(000)    PFT   BA $(000)

     Abatement & Control	 642  75,561.1     +217  +34,004.1

     Testing & Evaluation	 297  44,848.9     +126  +27,348.1

     The Fiscal  Year 1980   resource increases will allow the program
to almost double the levels of testing requirements initiated so that
the resulting data will be available in the next years to be used in
the assessment of potential risks.  The number of chemicals subject to
review will also double so that enough subsequent, in-depth assessments
will be completed to sustain the chemical control program at the same
levels in future years.

     Chemical Control	 175  10,463.2     +58  +2,476.2

     Additional resources in Fiscal Year 1980 for this program will
allow for full operation of the premanufacture review program with
adequate review of new chemical notices and action on those requiring
it.  Control actions will be taken on all chemicals identi-
fied as posing unreasonable risks.

     Information Integration... 127  19,029.1     + 33  + 4,152.9

     With these increased resources this program will be able to pro-
vide the information systems and services, information reporting and
monitoring support required for implementing the testing and
evaluation and chemical control programs.  A predictive monitoring
program to support toxic substances needs will be implemented.  Inte-
gration efforts at the intraagency, intergovernmental, and interagency
levels will be expanded in line with the generally expanding
toxic substances program activities.

     Enforcement	  78   3,805.6     +  8  +   572.4

     Toxic Substances Enforce-
       ment	  78   3,805.6     +  8  +   572.4

     The toxic substances enforcement program (headquarters and regions)
will continue, at a small increase over Fiscal Year 1979, to develop
and carry out inspection,  compliance monitoring, and enforcement activi-
ties related to promulgated TSCA regulations.  These activities will
continue to focus primarily on existing chemical control regulations,
including polychlorinated biphenyls and chlorofluorocarbonsj however,
efforts in enforcement of chemical testing, new chemical notification,
chemical information reporting, and export/import requirements will grow.
                                                                      OUU7

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                                  FY 1980 Total     Changes from FY 1979

                                  PFT  BA $(000)    PFT   BA $(000)

       Research & Development	 163  50,284.9     +104  +35,005.3

       Health Effects	  67  25,806.0     +55  +17,634.0

       The resource increase in Fiscal Year 1980 will permit expanded work
  in toxicology and protocol validation and development.  The health
  initiative will fill research gaps in neurotoxicological and behavioral
  research and establish interagency research programs focused upon de-
  termination of exposures, body burdens and adverse effects of toxic
  substances.  The program will also develop sound methods for detection
  of early signs of public health threats using biochemical toxicity
  indicators.

       Ecological Effects	  50  17,025.0     +41  +15,333.0

       The new ecological program thrusts will identify potential short-
  term, aquatic tests that can serve as screens for more expensive mam-
  malian tests; expand chemical structure-biological activity correlation
  to include acute and chronic toxicity effects, and develop manipulative
  subacute dose techniques for sensitive life stages to provide informa-
  tion about chronic effects.

       Determining human exposure to toxic substances requires an im-
  proved understanding of how toxic chemicals interact in and move through
  the environment.  Our research will identify quantitative, measures of
  such factors as rates of deposition and reactions in sediments, bio-
  accumulation, and degradation products which are typically the critical
  information missing in most exposure assessments.  We are also proposing
  to develop ecosystem models to use in making such estimates and to
  validate these models using natural ecosystems.

       Industrial Processes	  12   1,742.0     +  4  +1,302.0

       The industrial increase will provide for an expansion of toxic
  pollutant identification analysis for 3-7 products, including feed-
  stocks and intermediates, and a significant expansion of the chemical
  manufacture predictive model.

       Transport and Fate	  13   2,565.6     +  2  +   428.0

       With the increase in transport and fate, we will initiate re-
  search on characterization of soils and sediments to be used in
  testing of toxic chemicals, as well as on the development of an en-
  vironmental forecasting system, based on a benchmark approach for
  toxic chemicals.  Such a system, when developed, will enable the
  Agency to predict potential environmental problems due to toxic
  chemicals.
outs

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                                FY 1980 Total     Changes  from  FY  1979

                                PFT  BA $(000)     PFT   BA $(000)

     Technical Support	   18   2,445.0     +  2   +    244.5

     The technical support program is increased to allow establishment
of additional monitoring sites and the Mass Spectral Search System to
be augmented at a higher rate.

     Characterization &
       Measurement	    3     701.3      -    +     63.8

     This increase will enable the Agency to expand the  measurement
methods development work in sediment/soils and  water.
                                                                     OQU9

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-------
                     ENVIRONMENTAL PROTECTION AGENCY


FORM 1:  DECISION UNIT OVERVIEW
A) DECISION UNIT TITLE (AND CODE)
Toxic Substances: Health Effects (L105)
HO. OHD
REG.
MEDIA: Toxics
APPRO: R&D
 B) LONG RANGE GOALS AND MAJOR OBJECTIVES

      The objective of the toxic substances research program is the improve-
 ment of the state-of-the-art for rapid reliable, and economic screening tech-
 niques to be used in predicting carcinogenic, mutagenic, teratogenic, and
 other deleterious effects which result from exposure to chemical substances.
 The objective involves  (1) selecting known techniques for screening and de-
 veloping a fundamental scientific basis for validation of these techniques so
 that testing protocols can be developed,  (2) accelerating the development and
 validation of new and promising research  techniques for screening,, and (3)
 developing and conducting epidemiological studies which provide validation of
 research techniques as they relate to human populations, (4) providing re-
 search required by Clean Air Act (PL95-95) to specifically improve reliability
 of estimates of skin cancer related to stratospheric ozone depletion  (SOD) and
 to integrate these effects into a total assessment of SOD.

      Of particular Importance to this toxic substances research program are
 the initiatives in public health areas of scientific investigation relating to
 neurotoxicology, total exposure, and toxicity indicators of toxic substances.
 These initiatives are planned and under implementation to provide a coord-
 inated interagency public health research effort for the Federal regulatory
 agencies, particularly those participating under the Interagency Regulatory
 Liaison Group  (IRLG) program.    -                 '

      The toxic substances research goal is to provide research information
 in support of the priority regulatory objectives of the Office of Toxic Sub-
 stances (OTS) in carrying out the requirements of the Toxic Substances Control
 Act (TSCA) and of the Office of Air, Noise, and Radiation in carrying out the
 requirements of the Clean Air Act (CAA).

 C) FY 78 ACCOMPLISHMENTS

    An in vivo/in vitro teratology study procedure has been developed and
    standardized for use as a short-term screening technique.

    A procedure has been developed and evaluated for using skeletal variants
    as an indicator of biological effects  of environmental contaminants.

    Report on the interaction of acute and chronic Cd exposure with the
    metabolism of lindane, a substrate employed in the short-term model
    substrate assay.

    Validation of the Chinese hamster ovary mammafl?" cell bioassay for muta-
    genesis, chromosomal aberrations and sister-chromatid exchanges using 14
    carcinogen/non-carcinogen pairs.

    Evaluated ten high priority toxic substances for their ability to induce
    gene mutation, chromosomal aberrations, primary DNA damage, and oncogenic
    transformation in procaryotic and/or eucaryotic systems.

    Surveys have been conducted of incidence of skin cancer at various lati-
    tudes; identification of possible errors in optical amplification factor;
    and incorporation of findings as a report to Congress.

    A primary liver culture system has been developed and used to evaluate the
    cytotoxicity of a series of inorganic  and organic chemicals.        QCH 7
 EPA Form 2410-10 (8-73)

-------
                      ENVIRONMENTAL PROTECTION AGENCY

FORM 1:  DECISION UNIT OVERVIEW
  A)  DECISION UNIT TITLE (AND CODE)                    HQ   ORD     MEDIA:
                                                                         Toxics
  Toxic Substances:   Health Effects  (L105)   	REG:	APPRO:
R & D
  o  The Salmonella typhimurium/mammalian activation mutation  assay has  been im-
     plemented and work with complex environmental mixtures  (diesel exhaust
     extracts) has begun.


  D)  FY 79 PROGRAM DESCRIPTION

  o  Development of methodology for  neurobehavioral and neurotoxic screening
     procedures and evaluation of the neurotoxicity of chemicals  and  their
     effects on social  behavior (population studies).

  o  Conducting epidemiological studies  of Human Sterilants  and development  of
     a reproductive index  and time-to-tumor model development  as  a screening
     tool for long-term testing.

  o  Devising direct exposure measurements of  selected situations in  popula-
     ti'ons.

  o  Utilization of mutagenicity test data for estimation of risk.

  o  Evaluation of the  effects of toxic  substances on the immune  system  and
     development of a predictive index of postnatal health (biochemistry/
     teratology).

  o  The National Center for Toxicological Research (NCTR) will perform  long-
     term, low-dose experiments on compounds of interest to  EPA.

  o  Development of screening techniques using bioindicators.

  o  Develop quality controls for UV-B data collection; coordinate Federal
     research in SOD; and  update integrated assessment, including economic
     measures of benefits  of control of  SOD.

  ALTERNATIVES: An all  extramural effort was considered but  was considered a poor
  option because (1) EPA has now established expertise in terms of both  facili-
  ties and highly specialized interdisciplinary personnel, (2) additional cost of
  extramural work (3) lack of .specific expertise in extramural toxicology lab-
  oratories.  The team  of  EPA scientists work  well together  and understand the
  regulatory program requirements.   It is important to keep  the group intact.  It
  is highly unlikely that  non-EPA groups could offer the high degree  of  experi-
  ence,  specialized expertise,  or exposure facilities to conduct  the  multi-
  faceted, integrated toxicology research necessary for regulaory action.  The
  learning curve in the outside sector would delay outputs beyond the anticipated
  regulatory time frame.   Finally as a regulatory agency EPA requires a  core of
  inhouse scientific experts to serve as witnesses, provide  technical assistance,
  provide independent scientific assessment, short-term analysis  and  emergency
  responses to requests from the program office and the regional  programs.

      0018
 SPA Form 2410-10 (8-78)

-------
                   ENVIRONMENTAL PROTECTION AGENCY

FOPM 2{  DECISION UNIT  LEVEL ANALYSIS

!A.  DECISION UNIT TITLE AND  CODE          HQ       MEDJA|  TOX SUB
L105 HEALTH EFFECTS-TOXIC  SUB                     APPRO|  R & D

B,  RESOURCE SUMMARY       FY 78  ACT FY  79 C.  E.   FY 80  INC«    FY  80 CUM
          POSITIONS  PFT           8.0          12.0           9.0           9.0
 LEVEL              OPFT           2.0           fl.O           3.0           3.0
01  OF Ob            FTE                        17,7          1«,8          1<1.8
    BUDGET  AUTH.  (OPO.O)     1,400.0      8,172,0      fcfl?9,0      6*129,0
   C.  DESCRIBE THE INCREMENTAL ACTIVITIES Or THIS LEVEL C_>U.V DESCRIBE THE BENEFITS
      0= FUNDING AND THE CONSEQUENCES OF .MOT FUNDING.
  Activities
       o  Provide technical assistance to OTS with testing standards and
          evaluation of testing data.

       o  Develop sensitive analytical chemical methods applicable to broad
          classes of structures for priority compound groupings.  (R-10-1/15) .

       o  Develop and improve  sampling and analytical techniques for priority
          environmental toxicants in biological materials.   (R10-1/15)

       o  Automation and refinement of neurobehavioral toxicity screening
          procedures .

       o  Methods to evaluate  the effects of neurotoxic chemicals and other
          environmental factors on social behavior.

       o  Provide limited support for the Interagency Committee for Stratospheric
          Ozone Protection (ICSOP) , the required National Academy of Sciences
          study, and incorporation of health analyses into integrated assessments
          (including risk)  to  aid regulatory decision-making .

       o  Studies to determine comparative toxicological reactions in adequate
          and mammalian organisms.

       o  Develop and improve  methodology to assess the effects of toxic
          substances on the immune system.

       o  Develop methods to perform direct exposure measurements for selected
          situations such as persons exposed to hazardous gases, to indoor
          environmental contaminants, or to ambient concentrations  of industrial
          chemicals.

       o  NCTR will perform, at a reduced level of effort,  long-term, low dose
          toxicity studies  on  compounds of interest to EPA.
  i
  I Impacts

  |     At this level of funding the research program would be completely inade-
  quate to support OTS's research needs and regulatory requirements.  The
  .laboratory would be in a  personnel RIF situation and technical experts would
  be lost from the program.  This also is a totally inadequate response to the
  ,CAA  for research, reporting, and support for regulatory decision-making
  •regarding stratospheric ozone protection.  EPA will also be unable to support
  ;NCTR at the level of $4000K  as mandated by Congress.


-------
                            ENTAL  PROTECTION AGENCY

      ?: DECISION  UNIT LEVEL ANALYSIS
A,  DECISION  UK; IT  TITLE  AND CODE          HO       MEDIAi TO*  SUB
L105  HEALTH  EFFECTS-TOXIC  SUB                     APPRO: R  *  D
B. RESOURCE  SUMMARY       FY 76  ACT FY  79 C.  F.   FY  60 JNCR   FY  «0 CUM
         POSITIONS   PFT           9.0          IE,O           2.0         n.o
 LEVEL              OPFT           2.0           a.O           1.0          fl.o
02 OF  08             FTE                        17.7           2.4         17.2
   BUDGET  AUTH.  (000.0)     1,«00.0      8,172.0       1,226.0      7,355.0
   C DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LSVEt ONLY. DESCRIBE THE BENEFITS
     OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.

  Activities
       o  Perform epidemiological research,  including supporting exposure assess-
          ments, to determine susceptible human  populations and the acute and
          chronic health effects found in such  populations with occupational
          and community exposures to identified substances.

       o  Compare effectiveness of national  and international controls of ozone
          depleting activities in protecting health and welfare.  Risk and
          uncertainty will be considered.

       o  Correlate solar UV-B irradiation data at different latitudes and
          altitudes with skin cancer epidemiological data.

       o  Limited support of skin cancer epidemiological studies to correlate
          UV-B exposure to skin cancer incidence.

       o  Conduct epidemiological studies to investigate the male and female
          effects of exposures to suspect sterilant compounds.  A portion of
          this research will develop a community fertility index for use as
          a screening technique for populations,  (see Level 3 of 7)

       o  Increased funding for NCTR.

  Impacts
       The reduced  funding at this level of  the  toxics program, which was
  seriously reduced in FT 78, would further  render ineffective a significant
  segment of the methods development and the evaluatory process of environmental.
  chemical hazard.   Also, OTS would be deprived  of important technical expertise
  and research support, and the CAA requirements will receive a bare m-t^-tm  of
  support.

       NCTR will  be unable to perform the agreed upon research effort on long-
  term, low-dose  toxicological assessment of  chemicals of importance to  the
  Agency.
          OU20
 EPA Form 24lO.i1 (8-78)

-------
                     ENVIRONMENTAL  PROTECTION AGENCY
           DECISION UNIT LEVEL ANALYSIS
    .  DECISION UNIT  TITLE  AND CODE          HO       MŁDIA| TO*  SUB
  L105 HEALTH EFFECTS-TOXIC SUB                     APPRO! R  I  D

  B,  RESOURCE SUMMARY       FY 76  ACT FY  79 C.  E.  FY  60 INC&   FY  80 CUH
           POSITIONS  PFT           P.O          13.0           1.0         ia.O
    LEVEL              OPFT           2.0           4.0                        4.0
  03  OF 06             FTE                        17.7             5         17.7
      BUDGET  AUTH.  (000.0)     1,«00.0      6,172.0        B17.0     6,172,0
*
C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
   OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.

Activities

     o  Develop  a very specific community fertility index for use as a
        screening technique for populations.

     o . New and  improved procedures, including  isozyme studies and postnatal
        toxicologic  assessment, will be evaluated as indicators of the
        effects  of toxic substances on reproductive function teratology.
        (R8-11/13)

     o  Develop  personal dosimeter and measure  actual exposure of humans•to
        DV-B.
                                       «
     o  Correlate skip cancer incidence to exposure data to improve
        reliability  of findings.

     o  Study social distribution of cost of  health damages related to ozone
        depletion, both currently and in the  future.

     o  This level will bring the NCTR effort to the mandated $AM.

Impacts
                                     i  ?
     This work will  reduce uncertainties and  provide a better information
base for regulatory  decision-making.  Without this effort the Agency require-
ments will exceed the state-of-the-art knowledge regarding screening
methodology for  toxicant effects.  The available toxieological techniques
are insensitive  and  often inconclusive;   The  Agency must ensure that improved
techniques are developed and validated which  will be suitable for use in
carrying out the requirement for environmental  health and safety under TSCA.
Failure to support a research program such as this would stifle progress  in 1980
and beyond and disallow the development of appropriate analytical methodology.
Furthermore, projects listed as being of high priority to OTS will not be
initiated.
                                                                          0021
    EPA Fsrm 2410-11 (8-78)

-------
                  ENVIRONMENTAL PROTECTION AGENCY

FORM  2? DECISION  UNIT LEVEL ANALYSIS
•• M • •§•>•* <• • • • V •• • • <• • iB A • • •§ • • • •§ M M • • • M M M M ^^»^ M M M^ M ^ ^M K M • M M ^M ^ ^ ... ^ ^ M ^ •• «
 ^^       - ^ ™-  ^ — ^ ^ ^ ^ ^ ^^ ^ ^ ^ ^ ^ ^ ^ • ^ ^ ^ ^» -^ ^ ^v^ ^ ^ ^Wf ^ ^ ^»F ^ ^ ^ ^ ^ w^ 1W IP W ^ <^ ^ •• i* W
A, DECISION  UNIT  TITLE AND CODE         HO       HEUJAf TOX 5UB
L105  HFALT*  EFFECTS-TOXIC  SUB                     APPRO» P & D
B, RESOURCE  SUMMARY        FY 78  ACT FY  79 C, E.   FY 80  INCR    FY 80  CUM
         POSITIONS  PFT           a.o         12.0           5.0          17, o
 LEVEL               OPFT           2.0          «,0           1.0           5,0
OU OF  ns            FTE                       17,7    •      6,4          2«.l
   BUDGET  AUTH. (000.0)     1,^00.0      6,172,0         817.0      6/989,0
   C  DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
      OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.

  Activities
       o  Evaluate the use of time-to-tumor model as  screening for long-term
          tumor development testing.

       o  Develop screening techniques using bio-indicators such as organ-
          specific biochemicals and a group of isolated test systems (partial
          funding - see also Level 5 of 8.  (R-10-1/15) (R5-23/32).

       o  Improve reliability of estimates of the economic costs of skin cancer
          related to UV-B changes.

       o  Complete in-depth comparison of national and international controls
          of chlorofluorocarbons and other possible sources of stratospheric
          ozone depletion.

       o  Increased funding for NCTR to perform an additional long-term low
          dose study on a compound of interest to EPA.
   Impacts
       At this level of funding OBD would be able to  initiate research to
   improve the state-of-the-art for some screening methodologies for assessing
   human risk to some environmental chemicals. . However, other screening
   techniques, predictive tests and models needed by OTS would not be funded.
   This effort will both improve the reliability of estimates of the benefits
   (reduced costs of skin cancers) of control of ozone depletion and the
   ability to select effective and efficient control strategies.
          002.2
  EPA Form 2410-11 (8-78)

-------
                  ENVIRONMENTAL PROTECTION AGENCY

      2: DECISION UNIT LEVEL ANALYSIS
 . DECISION  UNIT  TITLE AMD  CODE          H3 .      MŁDIA|  TOX SUB
L105  HEALTH  EFFECTS-TOXIC  SUB                     APPRUj  R & D
" " " W <•• • 4P • 4M V •} • • • • • • • IV 0 • m • 4B Bfe M Ml ^ • fll ^ ^ ^ ^ ^ M ^ ^ ^ ^  m ^ ^ ^ ^ ^ ^ ^ ^ ^      ^
B. RESOURCE  SUMMARY       FY 76 ACT FY 79  C. E.   FY f?0  INCR   FY 80  CUM
         POSITIONS  PFT          8.0         12.0         "-J.O         20.0
 LEVEL             OPFT          2.0          q.O           1.0           6.0
05 OF 06            FTE                       17.7           a.5         28.6
   	 AUTH. (000.0)     1,400.0      6,172.0        8)7.0      9,806.0
   C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL 3KLY-. OESCRI3E THE SciSIEPiTS  --
     OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.


   Activities

        o  Develop  additional screening techniques using bioindicators including
           use of an established neoplastic transformation system to  identify
           metabolic substances which provide a better understanding  of the
           carcinogenic processes.  Research will be initiated to develop methods
           for screening urine and tissue from whole ayiwi  bioassay  tests and
           for evaluating urine in human population epidemiological studies.
           (See also Level 4 of 8)

        o  Provide  timely detailed integrated assessments of effects  of
           stratospheric ozone depletion.

        o  Increased funding for NCTR to perform an additional long-term, low
           dose study  on a priority chemical substance of importance  to
           Immediate activities of OTS in the implementation of TSCA.

   Impacts

        The utility of information, including health data, for decision-making
   will be improved and more readily available.  However, at this level of
   funding, OKD would  only be able to perform the screening, risk assessment
   and model development initiated in Level 4 and a modest amount of  ozone
   depletion assessment.  A small increase in NCTR's budget would be  allowed.
                                                                     OU23

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                                AL PROTECTION  AGENCY

FORM  2; DECISION  UNIT  LEVEL  ANALYSIS
A,  DECISION UNIT  TITLE  AND CODE         HO        MEDIAj  TO*  SUB
L105  HEALTH EFFECTS-TOXIC SUB                      APPRD|  RID
B,  RESOURCE SUMMARY       FY  78 ACT  FY 79  C  E    F Yo
         POSITIONS  PFT           6.0          i?.o          ,b.0          3b.C
^LEVEL              DPFT           2.0           4.0                         6  0
Ofe  °F  P6             PTE                        17.7          12.0          UQ.fc
    BUDGET  AUTH.  (000.0)     1^00.0      8,172.0      9,300.0      19,106.0
  C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
     OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.

 Activities

 NEDROTQXICOLOGICAL RESEARCH CENTER

    o  Complete the establishment of a  National NeurotoacLcological Research
       Center at EPA Research Triangle  Park to serve, particularly, the
       Federal Agencies forming the Interagency Regulatory Liaison Group
       (HtLG).  This center will carry  out a comprehensive, cooperative
       program to determine means of detecting the often subtle effects of
       toxic substances on the nervous  system and to evaluate the significance
       of these effects to humans.  Determining these effects can lead to
       highly sensitive screening and long-term research techniques.   The
       program for the Center involves the scientific disciplines of
       behavioral analysis, neurophysiology, neuropathology, neuroanatomy,
       and neurochemistry in the following functions:

       0  Develop and validate  new  short-term tests and currently existing
          methods to enhance stability, sensitivity, and cost effectiveness.

       o  Perform.   toxicity testing using existing methodologies to assess
          neurotoxic effects of priority compounds of initial interest  and
          to establish preliminary guidelines for methods to be used in
          toxicity testing of chemicals.

 TOTAL EXPOSURE,  BODY BURDENS, AND EPIDEMIOLOGY OF TOXIC SUBSTANCES

         Study  of the whole body pharmacokinetics and evaluation  of tissue
         distribution of the metabolites of toxic substances after acute and
         subacute inhalation  exposure.

         Study  of the whole body pharmacokinetics and evaluation  of tissue
         distribution of the metabolites of toxic substances after acute and
         subacute oral and dermal dosing.

         Comparison of the metabolic profile and whole body  burden of toxic
         substances administered by nose-only versus whole body inhalation
         exposure.

         Pathologic study, including histologic and ultrastructural changes
         that may be induced by oral versus inhalation versus dermal exposure
         *°1correlate ^duced morphologic  effects  with functional alterations.
EPA Farm 2410-11 (8-73)

-------
                         ENVIRONMENTAL PROTECTION AGENCY
   FORM 2: DECISION UNIT LEVEL ANALYSIS
     A.  DECISION UNIT TITLE (AND CODE)

       Toxic Substances:  Health Effects  (L105)
                                                   HO   ORD    MEDIA:   Toxics

                                                   REG.         APPRO   R & D
LEVEL
6 8

POSITIONS PFT
OPFT
FTE
BUDGET AUTH. (000.0)










-




—
     B.  RESOURCE SUMMARY
                               FY 78 ACTUAL  FY 79 C. EST.   FY 80 INCR.    FY 80 CUM.
4
 C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
   OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.

   o  Conduct epidemiclogical studies in generally  exposed versus  exposed
      human populations.

TOXICITY INDICATORS

   o  Development of potential enzymatic defense mechanisms  (detoxification)
      in the lung and liver as a basis  for  prediction of  toxicity  following
      various routes of exposure to toxic substances, ex:  glutathione
      peroxidase, glutathiene reductase, gloucose-6-phosphate  dehydrogenase,
      as well as  several  of the mixed function oxidases activities of cyto-
      chrome s,  i.e., aniline hydroxylase and benzpyrene(a)hydroxy-lase.

   o  Assessments of lung damage or altered cell populations following
      inhalation exposure'to toxic substances by measuring lung  enzymes and
      their isoenzymes (ex:  the increase in lung LDH level  is indicative  of
      a shift from Type I to Type II alveolar cells)  and  by measuring lung
      phospholipids and their fatty acid constituents (ex:   change in lung
      fatty acid  levels (arachidonate in particular)  loads to  alterations  in
      the biosynthesis of prostoglandins which leads  to increased  pulmonary
      embolism).

   o  Assess typical clinical chemistries indicative  of organ  damage (heart,
      liver, pancreas) ex:' serum and tissue COT, GPT, LDH, PHI, cholesterol
      triglycerides, lipase, amylase, aldolase,  alkaline  an  acid phosphatases,
      proteins, etc., and establish a typical batteries following  various
      routes of exposure.

   o  Evaluate hematological alterations following  exposure  to various
      toxic substances as measured by hematocrite;  RBC, WBC, and platelet
      counts; RTC hemolysis; platelet aggregation,  and prostaglandin bio-
      synthesis as clinical indicators  of toxicity.

   o  Measurement of creatinine and urea clearance  following exposure to
      toxic substances to assess renal  function.

   o  Histopathologic and ultrastructural effects in  organs  and  tissues of
      experimental animals exposed to toxic substances will  be studied
      to determine the target organs affected by the  test substances and
      correlated  with functional alterations as  manifested by  new  clinical
      batteries for detecting early effects of toxrcity.
                                                                      0025
   EPA Form 2410-11 (8-78)

-------
                         ENViRONMENTAL PROTECTION AGENCY
    FORM 2:  DECISION UNIT LEVEL ANALYSIS
     A. DECISION UNIT TITLE (AND CODE)

     Toxic Substances:  Health Effects (L105)
                                                    HQ

                                                    REG.
ORD
MEDIA:

APPRO:
Toxics

R & D
     B. RESOURCc SUMMARY
                                FY 78 ACTUAL  FY 79 C. EST.   FY 80 INCH.
             FY 80 CUM.
        LEVEL
                   POSITIONS
                            PFT
                           OPFT
                                FTE
                  BUDGET AUTH. (000.0)
     C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
        OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.

        o  Use of cytogenic and chromosomal aberrations in human lymphocytes to
          identify  early exposure to environmental agents.
                          •

        o  Development of inmunological techniques to identify serum proteins
          associated with tozicity.

        o  Examination of polyamines and phospholipids in human fluids as indica-
          tors of genotoxic events.

        o  Development of human fibroblast cell strains from representative
          normal and sensitive populations.

    Impacts
1)2
      Neurotoxicological research is-minisculaly decentralized among Federal
 agencies and totally inadequate to serve the multifaceted neurotoxicological
 research and support needs of Federal regulatory agencies.  The Neurotoxi-
 cologies! Research Center provides an immediate coordination and broadening
 the neurotoxicological research efforts and elimination of any danger of
 overlapping of activities among agencies.  Short-term benefits include
 responsiveness to the regulatory needs of the four IRLG Agencies, improved
 testing of selected toxicants, expert testimony, a coordinated research effort,,
 and centralized data base.  Long-term benefits are an improved array of
 methods for neurotoxicity testing, a better understanding of modes of action
 of neurotoxicants, and the development of cost-effective testing strategies.
 If unfunded neurotoxicology will remain a wide gap in the toxic effects
 information which is available to clarify the current understanding and
 mowledge in which the regulatory decisions surrounding implementation of
 rSCA are being made.

      Total exposure - In the coordinated approach to  dealing with toxic
 substances under several authorizations, the IRLG agencies will increasingly
 je forced to contend with the question of total exposure to and the body
 burden of the substances considered for regulation.   This will be particularly
 acute as the threat of multiple toxicants is dealt with in the regulations.
 The pathways to man must be much better defined and the metabolism and
 excretion of the substances much better understood.   In conjunction with
 studies which integrate monitoring and toxicology, there is also a strong
 leed to conduct epidemiclogical studies to see if suspected effects are
 nanifested in the exposed populations.   This combination seems to offer the
 >est opportunity for identifying and quantifying the  more subtle effects of
poxic chemicals at lower contamination levels in the  work place,  home,  and
  eneral environment.   Not funding  this  phase of  rasearrh  w-fll  1
    EPA Form 2410.11 (8-78)

-------
                      ENVIRONMENTAL PROTECTION AGENCY
FORM 2:  DECISION UNIT LEVEL ANALYSIS
  A.  DECISION UN IT TITLE (AND CODE)

  Toxic Substances:  Health Effects
                    HQ   ORD

                    REG.
MEDIA:   Toxics
APPRO:   R &  D
  B.  RESOURCE SUMMARY
PY 78 ACTUAL  FY 79 C. EST.   FY 80 INCR.
      FY 80 CUM.
LEVEL
-&— OF— -8-
POSITIONS PFT
OPFT
FTE
BUDGET AUTH. (OOO.Ot
















  C.  DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
     OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.


  questions, to be  raised in regulatory implementation of TSCA,  unanswered.
  The Office of Toxic Substances must have a good understanding  of how much
  of  a  substance  found in the ambient environment actually reaches a site
  of  action in man  and elicits a harmful  effect.

       Toxicity indicators - One of the most important tools that the regulatory
  agencies should have at their disposal  is the capability to detect early
  signs of public health threats.  Underlying such a capability  is an improved
  understanding of  how hazardous chemicals affect humans and how these effects
  are indicated before the disease state  becomes  irreversible.   In addition  to
  a compilation of  known clinical indicators of toxicity,  both new clinical
  indicators must be identified and monitored schemes to detect  such indicators
  early must be developed and tested.   This effort may become critical in
  limiting general  environmental exposure but,  additionally, would be of
  immediate importance in limiting dangerous occupational  exposures.   Leaving
  this effort unfunded will extend the years before we can respond to public
 health threats with preventative measures before the crisis period occurs
  to  call the problem to the attention of the Nation.
                                                                      0027
EPA Form 24)0-11 (8-73)

-------
                   ENVIRONMENTAL  PROTECTION AGENCY

FORM  a: DECISION  UNIT LEVEL ANALYSIS
A, DECISION  UNIT  TITLE  AND CODE          HO       MEUIM  TOX SUB
LJ05  HEALTH  EFFECTS-TOXIC  SUB                     APPRQi  R  & D

B. RESOURCE  SUMMARY       FY 78  ACT FY  7
         POSITIONS   PFT           6.0          J2.0          Jfi.C         5a.o
 LEVEL              OPFT           2.0          4.0          3.0           9.0
07 OF  08             FTE                        }7.7          19.2         59.8
   BUDGET AUTH, (000. C)     1,400.0      6,173.0      3,200.0     22,306,0
  C. DESCRIBE THE INCREMENTAL ACTIVITIESOF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
     OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.
 Activities
 NEUROTOXICOLOGICAL RESEARCH CENTER

    o  Conduct research to  determine mechanisms by which agents produce
       neurotozic effects.  Understanding mechanisms  facilitates develop-
       ment of more rapid,  accurate, predictive, and  economical screening
       procedures.

    o  Assess the effects of toxic substances on the  central nervous system
       by measuring serum,  RBC, brain and spinal cord choljae»terases and
       develop methodologies to assess their specific isoenzymes as selective
       indicators of toxicity, as well as neurotoxic  esterases which are
       indicators of neurotoxicity.

 TOTAL EXPOSURE. BODY BURDEN. AND EPIDEMIOLOGY OF TOXIC  SUBSTANCES
       Synthesis of radiolabelled compounds for metabolic  studies and the
       development of specific analytical methodologies  for each tissue sub-
       strate and/or excreta product to aid in the establishment of the phar-
       macokinetics of uptake, metabolism, storage and elimination of each
       toxicant or classes of toxicants.

       Biological accumulators of toxic compounds will be  studied to allow
       cost-effective quantitative measures of human exposure through important
       pathways not now capable of being measured because  of the lack of
       analytical methodology sensitive to low ambient levels.

       Microbiological screening techniques will assess  the biological availa-
       bility of toxic substances in environmental systems, as opposed to the
       total amounts, which are not truly indicative of  human exposure.
                                                               ^
       High priority chemical compounds identified by OTS  will be studied.
       Existing technological capabilities will be reviewed for use in
       human exposure and body burden monitoring system.   Items included
       will be exposure pathways analysis, analytical methodologies, models,
       and sampling techniques.
          0028
 EPA Form 2410-11 (8*73)

-------
                      ENVIRONMENTAL PROTECTION AGENCY

FORM 2: DECISION UNIT LEVEL ANALYSIS
  A.  DECISION UNIT TITLE (AND CODE)

   Toxic  Substances:  Health Effects (L105)
                    HQ    ORD   MEDIA:  Toxics

                    REG.         APPRO:  R & „
  B.  RESOURCE SUMMARY
FY 78 ACTUAL  FY 79 C. EST.   FY 80 INCR.
FY 80 CUM.
LEVEL
_J-OF--»-
POSITIONS PFT
OPFT
FTE
BUDGET AUTH. (000.0)










•





  C.  DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
     OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.
  TOXICTTY INDICATORS

     o  Study  of  the comparative toxicology of laboratory mammals and other
        potential test organisms in order to identify adequate short-term
        tests  for screening  toxicants  of concern to humans.

     o  Assess the effects of  toxicants on  human or non-human pathogens in both
        the aquatic and  terrestrial environments through:

        o   Study  of the  effects of toxicants, the resistance to which is
           coded  on Recombinant DNA, to cause selection for antibiotic
           resistance among  indicator  and pathogenic microorganism containing
           Recombinant DNA which also mediates for antibiotic resistance.

        o   Evaluation of the effects of toxic substances on susceptibility of
           fishes to disease and on the immune response of vaccinated fishes.

        o   Study  of transfer of Recombinant MA among pathogenic and indicator
           microorganisms in Marine sediment.

        o   Evaluation of the potential for  the transfer of Recombinant UNA
           mediated multiresistance to antibiotics in indicator species
           and pathogens carried up thru the food chain to its ultimate
           consumer, man.

  Impacts

      Understanding the mechanisms of action of neurotoxins and subtle variations
  in  the measurable body chemistries affected, permits more precision in research
  method results  and more reliability in their interpretation of use in developing
  regulations  under TSCA for protection of human environmental health.   To
  adequately evaluate total  exposure, critical refinement of analytical methods
  must be  developed concomitant with evaluatory research.  A better understanding
  of  cellular  and subcellular changes which can serve as early Indicators of
  toxic  effects can be obtained by study in submammalian species and making
  comparisons  with  higher animals.  These studies,  unfunded, would decrease
  significantly the ability  of the agency to develop the more rapid,  reliable and
  economical methods required by TSCA.   Such improved methods are essential for
  use under the Act in screening for chemicals which can be safely used without
  creating  hazards  to environmental health.

                                                                        0023
EPA Form 2410.11 (8-78)

-------
                   ENVIRONMENTAL  PROTECTION:  AGENCY

      Ł: DECISION U^IT  LEVEL  ANALYSIS
A,  DECISION UNIT  TITLE  AND CODE         HQ        MŁUIA|  TOX  SUB
L105  HEALTH EFFECTS-TOXIC SUB                      APPRDj  R &  D
^ ~* ^ ™ ^ ^ ^ ^ ™ ^ ^ ^ * • ^ ^ ^ W • ^ ^ VVVWVVWV w • •* • • ff> "• * W ™ ^ •> •• •• • •! " • w • •* ^ W ^ • •> Mi IV W M d • • 4V • •> •• • IV VB •
B,  RESOURCE SUMMARY       FY  78 ACT FY 79 c. E.   FY PO  INCR   FY so CUM
         POSITIONS  PFT           8.0          12.0          13. f         67.0
 LEVEL              OPFT           ?.0           Ut(j                         q.y
08  OF Otf             FTE                        17.7          1C. 8         70.b
    BUDGET AUTH. (000.0)     1,«00.0      6,172.0      3,500,C    ?5, 806.0
   t  DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
      OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.

  Activities
  NEUROTOXICOLOGICAL RESEARCH CENTER

  o  Evaluate health effects utilizing human epidemiological and clinical studies
     and  animal laboratory assessments involving multiple species.

  TOTAL EXPOSURE, BODY BURDENS, AND EPIDEMIOLOGY OF TOXIC SUBSTANCES

  o  Epidemiological staffing of three Health Maintenance Organizations to
     study  toxic substances exposures of persons receiving medical care.

  o  Serological survey of representative populations for protein bound adducts
     and  active metabolites of toxic chemicals.

  o  Clinical studies of persons exposed to  spills or unusual concentration of
     toxic-substances.

     Assist  the Center for Disease Control in the investigation of disease
     outbreaks, assessing the exposure to toxic chemicals.

     Biostatistical experimental modeling with digital and analog computer
     support.

  Lmpacts
       Critical to development of neurotoxicologic methods in the Research Center
  for use with chemicals under TSCA is  the  evaluation of comparative research
  .nformation available from various animal species.  Particularly critical
  ire values from epidemiological and clinical studies in the human.  Similarly,
  tpidemiological and clinical studies  associated with human disease processes
  ire of utmost importance in assessing the significance of total exposure
  lethods for evaluation of human hazards and validation of the results from
   hese methods.  Not funding these objectives would seriously reduce the
   ignificance and effectiveness of the initiatives described in levels 6-8
  rtiich are instituted for protection of public health.
          OU30
  EPA Form 2410-11 (3-78)

-------





















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-------
                     ".ENVIRONMENTAL PROTECTION AGENCY
   FORM 1: DECISION UNIT OVERVIEW
   .A) DECISION UNIT TITLE (AND CODE)
                                                   HQ
                                                         ORD
        Toxics Substances-Industrial Processes (L110) REG.
MED1A:
APPRO:
                                                                      Toxics
    B) LONG RANGE GOALS & MAJOR OBJECTIVES

       This research program is being conducted to support directly the current
   needs  of the  Office of  Toxic Substances (OTS),  specifically relating to
   Section 5  and 6(b) of TSCA Major objectives of  the program include:  quan-
   tification for industrial processes and products;  (2)  evaluation of  process
   alternatives  in-terms of  environmental acceptability based on toxic  .pollutant
   criteria;  (3)__definitJLon  of the occurrence of toxic substances as impurities
   in commercially available chemicals from a knowledge "of "process' chemTs"efy""and
   waste  composition; (4)  provision of technical assistance in terms of par-
   ticipation, in working, groups, reveiw of reports, documents, and development
   of expert  testimony as  required by OTS; (5) provision of perspectives on the
   occurrence and use of high priority TSCA chemicals for industrial processes;
   (6) provision -of information on the availability of substitute-.chemicals..to
   replace chemicals for which TSCA mandates decreased -consumption, including
   information on the economics of substitution; and (7)  provision of in-plant
   manufacturing process quality.control assessments.                     	
   C) FY  78 ACCOMPLISHMENTS
  |w
w
  There were four positions and $120,000 allocated  to  this program.   There
were no extramural resources.  The FY 1978 industrial  processes  toxics^pro-
 ram included the following activities:
   - Provision  of  technical  assistance and participation in Toxic Substances
     Control Act  (TSCA)  strategy and rulemaking work groups.

   - Provision  of  information on production and use by. industry of high _..-.
     priority toxic  chemicals,  including toxic contaminants or impurities
     in selected feedstocks,  intermediates, and products.

   - Assessment of alternative processing routes and in-plant manufacturing
     process quality control  steps  as methods .-to minimize  generation. P_f .t.qxic
    _.contaminants  in manufacturing the high priority TSCA chemical- Nitrobenzene/
     Aniline.                                           "...
                                                                        0035
  EPA Form 2X10.10 (8-78)

-------
                     ENVIRONMENTAL PROTECTION AGENCY
FORM 1:  DECISION UNIT OVERVIEW
 A)  DECISION UNIT TITLE (AND CODE)
HQ
      Toxics Substances-Industrial Processes (LllO)REG.
                                                       ORD
MEDIA:

APPRO:
                    Toxics

  D)FY 79 PROGRAM DESCRIPTION

    The requested FY 1979 resource level for this subactivity is $440,000
 and eight positions, including $200,000 for contract activities.   Specifically
 the program will provide:

 - Technical assistance on specific pollutant indentification/prediction and
   assessment of specified industrial processes to the Office of Toxic
   Substances, Office of Enforcement, Office of General Counsel, and other
   EPA operating program offices,  including regional offices.

 - Documentation, for Agency reference,  of summaries of industrial R&D
   experiences regarding in-process changes for TSCA priority chemicals.

 - Definition of alternative processing routes and modifications to mini-
   mize public exposure to toxic substances that result from the manufacture
   of:

 (1) Two specific high volume organonitrogen chemicals in which the potential
     for nitrosamine occurrence is high, both in the product and in waste
     stream; and

 (2) One specific high volume halogenated hydrocarbon (e.g., vinylidene
     chloride, hexachlorobenzene,  hexachlorobutadiene, hexachloro-
     cyclopentadiene in which the potential for environmental contamination is
     high during manufacture.)
         0038
 EPA Form 2410-10 (3-78)

-------
                  ENVIRONMENTAL  PROTECTION AGENCY

FORM  2J  DECISION UNIT  LEVEL  ANALYSTS
"»"'•»--"--••»-»»-•--•••»«••--••--••«-.•-...».•..»».•.«...».».»»»»„.»»».»»,„
   DECISION  UNIT TITLE AND CODE          HO       MŁ[>IA|  TOX SUB
   0  INDUSTRIAL  PROCESSES-TOXIC  SUB              APPRDj  R & D

8. RESOURCE  SUMMARY       FY  78  ACT FY  79 C. E.   FY Po"lNCR"™"p""""
         POSITIONS  PFT          fl.o          6.0           6.o          fe,  0
 LEVEL              OPFT                       1.0           i.o          1  u
01 OF  07            FTE                       9.a           B,U          &\U
   BUDGET AUTH.  (000.0)        100.0        
-------
FORM  a:
                           ENTAL PROTECTIO

                        LEVEL ANALYSIS
A, DECISION UNIT TITLE  AMU COUE
L11P  INDUSTRIAL  PROCESSES-TOXIC  SUB
                                                    MEDIA!  TOX SUfc*
                                                    APPRPJ  P & D
B, RESOURCE SUMMARY
         POSITIONS  PFT
 LEVEL              OPFT
02 OF  07            FTE
   BUDGET AUTH.  (000.0)
                            FV 76 ACT  f- Y 79 C,  E.
                                  4.0           8.0
                                                1.0
                                                9.«
                                loo.o        
-------
                    ENVIRONMENTAL  PROTECTION


      M  2!  DECISION UNIT LEVEL  ANALYSIS
   T^ DECISION UNIT  TITLE AND CODE         hC       MEDIA:  TOX  SUB
  LI to  INDUSTRIAL PROCESSES-TOXIC  SUB             APPRI^  R  &  o
  B.  RESOURCE SUMMARY      F-Y  ?e  ACT FY 79  c.  E.  FY PO  IHCR   FY eo  CUM
           POSITIONS   PFT          «,o          e,o                       B,O
    LEVEL             OPFT                       i.o                       1,0
  03  OF  o?            FTE                       v.«                       9. a
      BUDGET AUTH.  (000.0)       100. 0        440. 0         44.0        440,0
    C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY.'DESCFllBE THE BENEFITS

       OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.
                              ""•*


       Activities


       .  Continuation  of a modest effort on the chemical products  predictive model

         based on the  "unit process"  approach.


       Impact


         Not funding would delay development of the predictive model.
4
0038
  EPA Form 2jlQ.| |  (g.78)

-------
                  ENVIRONMENTAL PROTECTION  AGENCY

FOR"  2! DECISION  UNIT LEVEL ANALYSIS
*mmmmmmmm~mmmmm»mm»»mmmmmmmmmmmm~mmmmmm*mmmmmm»mmmmmmm»mm»mm»t
A,  DECISION  UNIT  TITLE AND CODE          HO       *EDIA|  TOX  SUB
L110  INDUSTRIAL PROCESSES-TOXIC  SUB              APPRO!  R &  D
B, RESOURCE SUMMARY
POSITIONS PFT
LEVEL OPFT
06 OF 07 FTE
BUDGET AUTH. CCOC.O)
FY 76 ACT FY 79 C. E.
a . o 8 . o
1,0
Q, 4
100.0 4^0.0
FY Ł0 INC*
4,0

4.0
1,302.0
FY 60 CU*
12.0
1.0
13.4
1,742,0
 C  DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. 'DESCRIBE THE BENEFITS
    OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.                     -.
                            »-

    Activities

       Expansion of toxic pollutant   identification analyses  for  3-7 products
       including feedstocks and intermediates.  Development of Product flow
       diagrams  for  specific OTS priority  chemicals.

    . Significant expansion of  the "new" chemical manufacture predictive model
      to indentify (a)  anticipated processes  involved, in manufacture,  commercial
      and consumer use, transportation,  and disposal;  (b)  expected  releases
      associated with individual processes; (c)  quality  and quantity of
      releases;  (d)  recommended control  methods;  and (e) risk analyses relative
      to feedstocks, by-products,  impurities,  and degradation products.


    . Expansion of regional technical support  to include toxic chemical spills
      and emergency response techniques.

    Impacts

       This level represents the fulcrum of the  ORD industrial toxics  program.
       Funding this level will  provide the Agency with a substantive source of
       industrial information concerning chemicals,  their  manufacturing
       processes, distribution  and use patterns,  waste disposal methods, and
       control options, together with a  viable analytical  model to  predict human
       risk as the chemical product  moves  through commerce. (It is  a generally
       accepted fact that exposure potential resulting from a chemical's use in
       downstream industries exceeds that  from its production).

    . A meaningful appraisal of a specific high  volume organic chemical's
      total exposure potential  offers no significance  without a thorough
      engineering understanding and  analysis of  the exposure  potential from a
      chemical production and that of its  derivatives  and  downstream uses.

    . Not funding this  level would eliminate any meaningful and substantive ORD
      technical support to OTS  and would particularly  weaken  the  OTS Office of
      Chemical Control  with respect  to TSCA's  quality  control and pre-marketing
      of new chemicals  provisions.

-------
















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-------
                     ENVIRONMENTAL PROTECTION AGENCY
FORM 1:  DECISION UNIT OVERVIEW
 A) DECISION UNIT TITLE (AND CODE)
Characterization and Measurement Methods
Development  (L115)
                                                   HO ORD

                                                   REG.
MEDIA: TOXICS

APPRO: R&D
  B)  LONG RANGE GOALS & MAJOR OBJECTIVES
Long Range Goals;  To develop improved methods for characterization, and
quantification of toxic chemicals in air, water, soil and sediment.  These
methods will be used in measuring exposure concentration of toxics in the
environment.  Such exposure concentration is needed in defining risks under
TSCA.

Major Objectives;  To develop (1) improved collection devices for toxics in
 air,  (2) improved separation techniques for characterization of toxics in air,
 (3) methods for characterization and separation of toxics in sediments,
 and  (4) methods for characterization of nonvolatile organics in water.  Work
 will  also involve measurement of exposure concentration of selected toxics in
 air samples and to a limited extent in water and sediments.
  C)  FY 78 ACCOMPLISHMENTS             ;

 Reports on  (1) evaluation of gas chromatography mass-spectrometric computer
 techniques for measurement of toxics in air (2) laboratory and field testing
 of a  monitoring instrument for unsaturated halogenated organics and (3)
 feasibility of long-path optical techniques for monitoring of airborne organic
 toxic substances.
AD)  FY 79 PROGRAM DESCRIPTION
Activities;  Technical assistance to Office of Toxic Substances  (OTS) in the
 area of measurement of toxic chemicals in air, water and sediments;
 methods development for measurement of three classes of toxics in air;
 improved collection and separation methods including resin, High Pressure
 Liquid Chromatography  (HPLC), and solvent extraction for limited number
 of toxics in air and measurement of exposure levels of a limited number of
 toxic chemicals in air and water samples using improved methods.

 Planned Accomplishments;  Reports on  (1) methods for identification of
 toxics in selected sources in air,  (2) improved collection and separation
 techniques for toxics in air (3) determination of  exposure concentration
 of toxics in air and water samples.

 Considered Alternatives:  Work will involve a combined extramural and
 .nhouse effort.  All extramural or  inhouse alternatives were considered
 ut were rejected, because assigned positions are  inadequate for all inhouse
 ork and all extramural work would  require critical mass of inhouse staff
 .n planning, supervising projects,  evaluating results and providing technical
 ssistance, making this option cost-ineffective.
EPA Form 24)0-10(8-78)
             00«*3

-------
                  ENVIRONMENTAL  PROTECTION AGENCY

FORM  2: DECISION UNIT  LEVEL  ANALYSIS
•••-•"*•"•"""•*•••••"-•••••••••-•••••«•»••••»-•••».•».......»
A. DECISION  UNIT TITLE AND CODE         HQ       MEDIM  TOX  SUB
Liis  CHRCTRZTN & MSRMNT MTHDS  DVLPMNT-TOX SUB   APPROI  R g  D"
Bf RESOURCE  SUMMARY       FY  78  ACT FY  79 c.  E.   FY  ao
         POSITIONS  PFT           3.0          3.0          ~2.~0       ""  2~0
 LEVEL              OPFT                        1.0           1.0           l.o
01 OF  09            FTE                        
-------
FORM
                  ENVIRONMENTAL  PROTECTION

         DECISION UNIT  LEVEL ANALYSIS
   DECISION UNIT TITLE  AND CODE          H0      MEDIA: TOX  SUB
  is  CHRCTRZTN  & MSRMNT  MTHDS  DVLP*NT»TOX SUB  APPROI R  &  D
B, RtSOJRCE  SUMMARY
         POSITIONS  PFT
 LEVEL              OpFT
02 OF  09            FTE
   BUDRt-T AUTH.  COOO.Q)
FY 7P  ACT FY  79 C. E.  -F-Y *0  INC*
       3.0          3.0           1.0
                    1.0
                    «.«             5
                                 96.0
90.0
637.5
                                                                    FY  80 CU*
                                                                           3.0
                                                                           1.0
                                                                           «.«
                                                                         57a.O
  C.  DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
     OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.


  Activity;

  o  Analysis of monitoring data for exposure measurements of toxics on
     selected air  samples (identified by OTS) using improved techniques.

  Impact;
                                       i
  o  Funding at  this level will provide  methods of measuring  exposure of toxics
     in air.  These exposure data wo.uld  be used in risk analysis under TSCA.

  o  The Agency  is required under Section'-A and Section 5  of TSCA to define
     risks to humans and the environment.  Risk estimates  require a good
     .knowledge of  the exposure concentration of toxics. Deletion of this
     level would deny provision of credible data on exposure, and thus would
     delay the development of a credible risk estimate process.

EPA Form 2410-11 (8.78)

-------
                  ENVIRONMENTAL  PROTECTION  AGENCY

FOPM  21  DECISION UNIT  LEVEL ANALYSIS
A. DtCTSION  UNIT TITLE  AND CODE          HO       MEDIM  TOX SUB
L115  CHRCTRZTN  8, MSRHNT  MTHUS  DVLPMNT-TOX SUB   APPRCj  f?  R D
  ™ ^ ^   ^ * ™ ^ ^ " ^ ^ ^ ™ ™ ™ * ™ ™ ™ ™ ** ™ ^ ™ ™ W * •• W OT • • W ^ • " •> W V " " ^ W ^ • •* " ** •• B> ^ ••> W * 9 "* •* W
B. RESOURCE  SUMMARY       FY ?e ACT PY  79 c, i»  FY f
-------
                    ENVIRONMENTAL PROTECTION  AGENCY

    RM  2:  DECISION UNIT  LEVEL ANALYSIS
   , DECISION  UNIT TITLE  AND CODE          HO      METIA| TOX  SUP
  L115  CHRCTRZ1N  & MSRMNT MTHOS  DVLPMNT-TOX SUB  APPROl R  &  D

  B. RESOURCE  SUMMARY       FY 78  ACT FY  79  C. E.   FY 80 INCR   FY 60  CUM
           POSITIONS  PFT           3.0          3.0                        3.C
   LEVEL             OPFT                        1.0                        liO
  QU OF  f9            FTE                        4.«                        4,4
     BUDGET AUTH,  (000.0)        
-------

















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                     ENVIRONMENTAL PROTECTION AGENCY
FORM 1:  DECISION UNIT OVERVIEW
  A)  DECISION UNIT TITLE (AND CODE)

     Toxics- Technical Support (L125)
HQ  ORD

REG.
MEDIA: Toxics
APPRO:
  BJ  LONG RANGE GOALS & MAJOR OBJECTIVES  The, objective  of  this  program is  to
 provide support  to Agency operating  programs to  enable them  to fulfill Agencv
 mandates.  Technical support  services fall  into the  following '-categories:-
 (1)  Responding to scheduled  and  unscheduled  emergency  requirements  for field,
 analytical and data analysis support to  provide  data of known  quality through
 specialized field and  analytical studies organizing that  data  into  summaries
 and  analytical reports;  (2)  Adapting and modifying  basic  state-of-the-art
 techniques to gather empirical evidence  of levels of specific  pollutants,  or of
 suspected  pollutants;  (3)  Performing and reporting  the results of complex
 chemical or physical analyses;  (4) Testifying as expert witnesses at
 administrative and judicial proceedings -and  consultations.
   Analyses range.from gross contamination to the detection  of sub-microgram
  qualities.  Adaptation of state-of-the-art techniques  is  often required.

  C)  FY 78 ACCOMPLISHMENTS Program was not ia existence in FY'77. Became
 marginally operational in FY'78  (only $464K). Planned and carried  out several
 field studies to determine the ambient concentrations  of  several industrial
 pollutants, i.e., aryl phosphates. Established procedures for  "fence  line
 monitoring: and  performed several monitoring studies.  Performed aerial photo-
  raphic interpretation of industrial sites to determine demographic alteration
 coincident with industrial development.  Aquired  aerial photography  of several
 sites and performed interpretation to determine  management practices.
  D) FY 79 PROGRAM DESCRIPTION Carry out environmental assessments across the
 media of the impact of various classes of toxic compounds - do retrospective
 analysis of the use of photo-interpretation of demographic alteration coincident
 with industrial development at 10 sites - monitor the ambient air of 20
 industrial chemical manufacturing installations for toxic emissions. Up to 50
 samples will be analyzed from these sites.

    Initiate a Mass Spectral Search System (MSSS) expansion to begin to cover some
 25000 materials for which spectra are needed. Expand screening and carry out a
 program of on-site visits by ORD experts as consultants for OTS.

    Since the technical support program is the application of in-house expertise
 growing out of research activities to Agency problems,  a "complete contract
 operation is not possible. However, it is not necessary for this to be a
 completely in-house activity. Contractors can be used to supplement in-house
 expertise and to do tasks which can be done more effectively extramurally.  A
 mix of contractor and in-house laboratory personnel is planned which will use
 contractors as much as possible.

        OU50
 ŁPA Form 2410-50 (8.73)

-------
                  ENVIRONMENTAL  PROTECTION  AGENCY

 iDRH  2!  DECISION UNIT  LEVEL
A, DECISION  UNIT TITLE AND  CODE         HO       MŁPI*I TOX  SUB
L125  TECHNICAL SUPPORT                            APPRDl P  &  D
B, RESOURCE  SUMMARY       FY  76 ACT  FY 79  C.  E.  FY PO INCR   FY  80 CUM
         POSITIONS  PFT         ift.o          ife.o         12.0         12,0
 LEVEL             OPFT                        2,0           2.0          2.0
01 OF  05            FTE                       19.9         ife.9         16.9
   BUDGET AUTH. (000, C)       400.0      2,200.5      3,650,5      1,650,5
   C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
     OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.


   - The  base level includes the analysis of aerial photography of industrial
     sites  and  ambient monitoring of manufacture/user sites.

   - No more  than 10 sites will, receive a retrospective photo-interpretative
     analysis of demographic alteration coincident with industrial development.

   - The  ambient air will be monitored at 20 chemical manufacturing sites for
     stray emissions.   Up  to 50 analyses will be made on  these  samples to
     determine  in so far as possible the toxic material (s) being lost to the
     environment.

   - Samples  of soil, water, flora/fauna and air will be  analyzed for two classe
     of toxic chemical  substances (such as aryl phosphate) at several sites to
     make environmental assessment of the impact of these materials.

   Impact

     Without funding,  the capability to EPA/OTS to assess potential toxic
   problems associated with a specific toxic chemical substance  would be
   -severely limited.  Technical assistance to  OTS would be eliminated.

   - The  core mix of skills would be -.-severely impacted. The Agency would lack
     expertise  to assess the potential biological and environmental impacts
     associated with contamination by a toxic  chemical substance.

   - It will  not be possible to design optimum monitoring plans for a particular
     environmental  situation because the necessary preliminary laboratory studies
     will not be performed.
                                                                       0051
 EPA Form 2410')] 'B.78)

-------
                  ENVIRONMENTAL PROTECTION  AGENCY

FORM  2:  DECISION UNIT  LEVEL ANALYSIS
A, DECISION  UNIT TITLE  AND CODE
L125  TECHNICAL  SUPPORT
                HQ
MEDIA i'  TOX SUB
APPRO|  R & D
B, RESOURCE  SUMMARY
         POSITIONS  PFT
 LEVEL              OPFT
0? OF  05            FTE
   BUDGET AUTH,  (000.0)
FY 78  ACT FY  79  C. E.
      16,0         16,0
                    2.0
                   19. 9
    «00.0      2,200.5
 FY (?0  INCR
         2.0

         1.0
       330.0
FY 80  CUM
      1«.0
       2.0
      17.9
  1,980.5
  C.  DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
     OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.
       - Expand the screening of ambient air pollutants  to 40 sites.
       - Expand the Mass Spectral  Search System (MSSS) data bank to include
         spectral information on 1000 toxic substances,  their derivatives and
         analogs.  This is about 4% of the compounds which we now feel should be
         in the system.
       - Carry out environmental assessments for three more classes of compounds,
       - Travel for OTS to field locations of on-going program activities.(60
         sites)-all travel expenses $3,000.
       - Assist OTS in evaluating  test resultsT contract results and contract
         proposals (12 evaluations)-$6,000 travel expenses.

       Impact

         Level would provide data on ambient concentrations of toxics to Regions
       and OTS.  Not funding would eliminate this information; MSSS data bank
       would not be up-graded to meet TSCA requirements.
           OU52
EP.A Form 2410-11 (8-78)

-------
t:
            ENVIRONMENTAL  PROTECTION AGENCY

2! DECISION UNIT  LEVEL  ANALYSIS
 A,  DECISION UNIT  TITLE AND  CODE         HQ       MEl'lM  TO*  SUB
 1125 TECHNICAL SUPPORT                            APPRUj  R fc  D
 _	_	_ —	•^••^••^••^•••••••••••••^•^•••^••^^^'•^••^•nE»'M»fg»»«n>«
 Wf • W >p •> W W Mi •> • •• V V (• IP • <•• •» W " • » •• » ^ ^ IP ^ ^ ^ 1W W ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ •" ^ ^ ^ •"" ^ ^ ^ ^ ^ "" ^ ^ ^ ••"• ^ ^ ^ •^
 9,  RESOURCE SUMMARY      FY 76 ACT FY 79 C.  1.  FY  PO  INC»*   FY 60
         POSITIONS   PFT         18.0         16,0          2,0         16.0
 LEVEL             OPFT                       2,0                        2.0
 03  OF P5             FTE                      19,9          1,0         18,9
    BUDGET  AUTH, (000,0)       400,0      2,200,5        2?0,0     2»200,5
   C.  DESCRIBE THE INCREMENTAL ACTIVITIES OF TH!S LEVEL O\'LY. DESCRIBE THE BENEFITS
      OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.
   - Expand MSSS by an additional 300 compounds.   This brings the MSSS to about
     6% of the compounds identified.
   - Carry out environmental assessments for two  more classes of compounds.
   - Additive screening for base line data on the presence of specific materials
     at 12 more sites at -least.

   Impact

      Not funding this level will result in the loss  of  the data needed by OTS
      .the ambient concentration of important toxics.  Environmental distribution
    f three classes of toxics will not be obtained.   Our overall capability to
   analyze  for toxics will be reduced by 450 priority compounds and the in-hous«
   capability to monitor for these materials will not be developed.
                                                                   0053
  EPA Form 7410-11 (8-70)

-------
                  ENVIRONMENTAL PROTECTION AGENCY

"ORM  2}  DECISION UNIT LEVEL ANALYSIS
                                                      .
A, DECISION UNIT  TITLE  AND CODE
.125  TECHNICAL  SUPPORT
                HO
    Ai  TOX SUB
APPROt  P & D
3. RESOURCE SUMMARY
         POSITIONS  PFT
 LEVEL              OPFT
14 OF  C5            FTE
   BUDGET AUTH.  (000.0)
FY 78  ACT FY  79  C. E.
      18.0         16.0
                    2.0
                   19.9
    100.0     2,200.5
 FY 60
         2.0

         2.0
FY 80  CUH
      18,0
       2.0
      20.9
  2/445.0
  C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFP.;;
     OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.
    - Expand MSSS by an additional 300 compounds.   This would reach 7% of the
      presently identified compounds.
    - Carry out assessments for  approximately three more classes of compounds.

    Impact

       Each of these projects adds another increment to EPA's-understanding of
    the magnitude of the toxic problems.  This understanding is a significant
    part of the base on which OTS must operate.  Not funding will further
    exacerbate both the problem  of a limited scientific base for the Agency and
    the shortage of in-house skills to cope with new toxic problems.
 EPA F.orm 2410-11 
-------


















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                     ENVIRONMENTAL PROTECTION AGENCY
FORM 1:  DECISION UNIT OVERVIEW
 A)  DECISION UNIT TITLE 'AND CODE)

 Toxics'Ecological Effects (L130)
KQ  ORD

REG.
MEDIA: Toxics

APPRO: R&D
 LONG RANGE GOALS AND MAJOR OBJECTIVES

 The objective of this research is to provide techniques for evaluating-the
 environmental hazards of toxic substances.  This research supports
 Section 10(c) and 10(e) of the Toxic Substances Control Act (P.L. 94-469).
 This research will result in (1) the completion of those significant test
 methods already under development; (2) the modification, based on recent
 research experience, of existing methods; (3) the continued efforts to"" "
 develop procedures for additional critical life forms; (4) the development
 of short, less costly protocols as reliable estimates of potential hazard;
 and (5) the verification of these methods by round-robin testing involving
 the U.S. EPA Ecological Effects laboratories and several non-governmental
 laboratories.                                                         ~~

 A major coordinated effort will be undertaken to develop tools to evaluate
 the ecological component of human exposure to contaminants in the environ-
 ment .

 Part of this Decision Unit is oriented toward atmospheric research with
 objectives toward improving knowledge of ecological effects of stratospheric
 ozone depletion (SOD) and integrate these into total assessments of SOD.

 FY 78 ACCOMPLISHMENTS

 For the freshwater and marine acute fish and invertebrate testing methods,
 contracts have been awarded for calibration (round-robin testing).  Preparation
 for calibration of other test methods scheduled for FY 79 are underway.
 This involves developing an agreed upon protocol and for some tests a
 workshop has been planned.

 Tentatively identified effects of enhanced UV-B on shrimp and anchovy larvae
 and some other marine organisms; identified "greenhouse effects" of
 chlorofluorcarbons and SOD impact on climate, and contributed findings to
 integrated assessment of SOD.

 FY 79-PROGRAM DESCRIPTION

 Refine, calibrate* and publish testing methods for evaluating the hazards
 of toxic substances.  Testing protocols developed will be used to assess
 toxicity and bioconcentration in freshwater, marine,  and terrestrial
 environments.   Assist the Office of Toxic Substances in the writing of
 testing standards in 4 areas, and assist in evaluating data submitted in
 .response to testing standards.   Provide limited research on ecological
 effects of stratospheric ozone depletion, and support for the Interagency
 Committee on Stratospheric Ozone Protection (ICSOP)  and study work required
 under the Clean Air Act Amendments (CAM).  Research will continue on the
 marine food chain.

                                                                       UU57
EPA Form 2410-10 '8-*Ł)

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                     ENVIRONMENTAL PROTECTION AGENCY

FORM 1:  DECISION UNIT OVERVIEW
  A)  DECISION UNIT TITLS (AND CODE)                    HQ   QRD     MEDIA: Toxics

 	Toxics Ecological Effects	RSG-	APPRO: R&p
  *  Calibration will be via round-robin test and 2 EPA laboratories and
    4 contract laboratories for each test, except for tests of longer
    duration, i.e., fish chronic and embryo larval.   Calibration is needed
    to quantify interlaboratory variability of screening tests for toxic
    substances so that OTS can properly interpret data obtained by industry.

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                  ENVIRONMENTAL PROTECTION AGENCY

   M  2} DECISION UNIT LEVEL ANALYSIS
A. DECISION  UNIT  TITLE AND CODE          HO       MŁPIA|  TO*  SUP
L130  ECOLOGICAL EFFECTS                            APPROj  R &  D
• •> |B • ^HlVIB^MPWV^^ ^ ^ ^ M M M ^ ^ ^ ^ M ^ ^ ^ ^ M ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ AB ^ ^ ^ ^ ^-^ ^ ^ ^ ^ ^ ^ ^  ^ ^ ^ _ «b ^ ^ ^>    __
 ™*^^^™'^'™^^'""^"^^^^^^^^^^^^^^^^^^^^^^i»^w«»^^«»^*iw«i^^^^^»www»«f^»»«»»ip^wwai»«p|»w
B. RESOURCE  SUMMARY       FY 78 ACT FY 79 c. E.   FY »o  INCR    FY eo CUM
         POSITIONS   PFT          7.0          9,0           7.0           7.0
 LEVEL             OPFT                        2.0           2.0           2.0
01 OP 06             FTE                       11.9          10.9          10.9
   BUDGET  AUTH. (000.0)       550.0      1,692.0      J,2fc9.0      1*269.0
   C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY.  DESCRIBE THE BENEFITS
     OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.

  Activities

   . Assist the Office of Toxic Substances of testing standards in 6 areas,  and
     assist in evaluating data submitted  in response to various testing
     standards.

   . Calibrate the  ethylene stress test using 3 chemicals and 3 plant species.
     Complete calibration.

   . Complete calibration of the embryo larval test for one freshwater  fish
     and  one  marine fish.  Two toxic  substances will be evaluated.

   . Complete calibration of Daphnia  magna chronic test.

   . Complete calibration of marine polychete acute test.

   . Complete calibration of mysid shrimp chronic test.

   . Complete calibration of marine and freshwater benthic (sediment-inhibiting)
     invertebrates acute test.

   . Provide  limited executive secretariat support in Interagency Committee  for
     Stratospheric Ozone Protection (ICSOP).  Complete the National Academy  of
     Sciences (NAS) study and prepare state-of-the-art assessments to support
     regulatory decisions.

  Impacts
   .  Funding at this level will provide technical assistance to OTS  in
     developing testing standards and  evaluating the resulting data,  and will
     allow completion of calibration of 8 testing procedures needed  by OTS.

   .  Not funding will delay and diminish the effectiveness of OTS  in implementing
     Sections 10(c) and 10(e)  of TSCA.

   .  This is an inadequate response to the CAAA for ecological effects research,
     reporting, and decision support regarding reulation to protect
     stratospheric ozone.


                                                                     0059
EPA F

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                  EN vlPC'^E^TU PPPTFCTION.
FORM  2?  DECISION UMT  LEVEL
A, DECISION UNIT  TITLE  AND CODE         HO       MEUJM TOX  SUB
L130  ECOLOGICAL  EFFECTS                           APPRPj p &  D
^ • * <« * " >*W*»wV^«BWW«*«WWW^«MWMIVWVVVVMWWWWO4pWWVWOW*VkV0MiVMI*MlWV«idaiMW4iW4MW
B, RESOURCE SUMMARY       FY 78 ACT FY 79 C.  E.  FY  PO !NC*   FY  80  CUM
         POSITIONS  PFT          7.0          o.o          i.o          8.0
 LEVEL              OPFT                        2.0                        2.0
02 OF  o«            FTE                       11.9             5         11. «
   BUDGET AUTH.  (000.0)       550.0     t,t>P2.0        354.0     1,523.0
  C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
     OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.

    Activities

     .  Calibrate  freshwater fish (fathead minnow) chronic  test.  Although
       certain  short-cut tests can estimate chronic toxicity to some level
       of confidence, the variability  of the chronic test  itself needs
       calibration.

     .  Develop  quality control program for collection and  use of UV-B
       irradiation data.

     .  Calibration of UV-B monitoring  instruments.

     .  Minimum  study of UV-B effects on aquatic food chain organisms.

    Impacts

     .  Funding  at this level will allow calibration of a screening test
       identified by OTS as a high priority.

     .  Not funding at this level will  delay efforts to develop short-cut tests
       to estimate chronic toxicity for freshwater vertebrate organisms.

     .  This  is  a  bare minimum effort to meet CAAA requirements.

           0060

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                              AL PROTECTION  AGENCY

      2;  DECISION  UNIT LEVEL ANALYSIS
A. DECISION UNIT  TITLE  AND  CODE         HQ       HEDIM  TOX 8UB
L130  ECOLOGICAL EFFECTS                           APPROi  R & D

B, RESOURCE SUMMARY       FY 78 ACT  FY 79 C.  E.  FY  PO  INCR   FY 80 CUM
         POSITIONS  PFT          7.0           9.0          1.0          9.0
 LEVEL              OPFT                        2.0                       2.0
03 OF  08            FTE                       11.9            5         11.9
   BUDGET AUTH.  (000.0)       550.0      1,692.0        169.0      1,692,0
  C.  DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
     OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.

   Activities

     .  Calibrate marine fish (shppeshead  minnow) chronic test.   Although certain
       short-cut tests can estimate chronic  toxicity to some level  of
       confidence,  the variability of the chronic test itself needs
       calibration.

     .  Study social distribution of costs of ecological damage  due  to ozone
       depletion.

   Impact

     .  Funding at this level will allow calibration of a screening  test
       identified by OTS  as a high priority.

     .  Not funding at this level will delay  efforts to develop  short-cut
       tests to estimate  chronic toxicity for marine invertebrates.

     .  Ozone depletion studies will provide  information useful  to support an
       equitable distribution of the costs of control.
                                                              OUG1
EPA Form 2410-11 (8-78)

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                  ENVIRONMENTAL PROTECTION  AGENCY

FORM  2}  DECISION UNIT  LEVEL ANALYSIS

A, DECISION UNIT TITLE  AND CODE          HQ      *EPIM TOX  SUB
L130  ECOLOGICAL  EFFECTS                          APPRP| R  &  0

B, RESOURCE SUMMARY       FY 78 ACT FY 79  C.  E.   FY f»C INCR   FY  BO CUM
         POSITIONS  PPT          7,0          9,0           1.0         10.0
 LEVEL              OPFT                        2.0           1,0          J.O
OU OF  06            FTE                       11.9           2,«         1«.3
   BUDGET AUTH.  (000,0)       550.0      1,692.0        169,0      1,861,0
  C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
     OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.

     Activities

      . Compare  existing freshwater and marine aquatic toxicology  data with
        mammalian toxicity data on an equivalent basis in order  to identify
        potential short-term aquatic test that can serve as screening tools
        for toxicants of concern to humans.  Conduct coordinated research
        with EPA Health labs to refine promising aquatic tests as  predictors
        of human health effects.  Data developed in levels 1, 2  and 3 will be
        used.

      . Develop  stable portable UV-B sources for field calibration of
        instruments.

     Impacts

      . Funding  at this level will allow an estimate to be made  of the
        feasibility of using aquatic organisms as predicators of human health
        effects.

      . Not funding at this level will delay efforts to identify potential
        short-term aquatic tests that can serve as screening toosls for longer,
        costlier mammalian tests.

      . Use of portable calibration instruments will improve the reliability
        of data  obtained from field research.
             OU62
EPA Form 2410-11 (8-78)

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                  ENVIRONMENTAL  PROTECTION; AGENCV

FORM  ?«  DECISION UNIT  LEVEL  ANALYSIS
Af PECISION  UNIT TITLE AND  CODE         MQ       HgUI^l TOX  SUB
L130  ECOLOGICAL EFFECTS                           APPRDi ft &  D
»^^»i»»
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                              TAL  PROTECTION AGENCY

FORM  2; DECISION I'M T  LEVEL  ANALYSIS

A.  DECISION  UNIT TITLE AND CODE         HQ "*""%EUIA|*TOx"su§""*""""""
L130  ECOLOGICAL EFFECTS                           APPRC'f  R &  D
••~-~~m-»*"»»~»»»»»»»»»»»mmmmmmmmmmm-mmm*o»mmmmmm~~»m»m*mmmmmmmmmmm»mmmm
B.  RESOURCE  SUMHARY       FY  76 ACT FY  79 c.  E.   FY  PO  INCR    FY eo  CUM
         POSITIONS  PFT          7.0          9.0           7.0          17.0
 LEVEL              OPFT                       2;0                        v;
06  OF  OB            FTE                      11.9           7.0          2JN
    BUDGET AUTH. (000,0)       550.C      1,692.0       3,000.0      5,025.0
   C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
     OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.
   Activities

    . Develop methodologies  to  predict the transport,  persistence, degradation,
     and transformation  of  various classes of toxic  chemicals  on the  basis of
     intra-and inter-environmental process pertaining to aquatic and  soil
     environments.  Processes  to be studied will include photodegradation,
     microbial degradation, water-plant transport in aquatic and aqueous-
     sediment environments.

    . Develop methodologies  to  predict the persistence, movement, transformation,
     and degradation of  toxic  chemicals in air.  Processes to  be studied will
     include photolysis  in  air, OH radical reactions and reactions with other
     gases.  These studies  will lead to the development of improved protocols
     to be used in testing  of  toxic chemicals.

    . Develop methodologies  to  predict the fate, transport and  transformation of
     toxic chemicals in  ground waters, with emphasis on leaching process.

    . Study the effect of inert ingredients present in toxic substances on the
     environmental rate  processes.

    . Validate environmental process parameters in laboratory ecosystems, smog
     chambers, and in the field for toxics in the environment.

   jmpact

    . Funding at this level  would enable the Agency to develop  methodologies for
     understanding and validating laboratories environmental process  results
     in laboratory model ecosystems and the field.  Such an understanding is
     essential in developing multimedia exposure assessment models.   Exposure
     estimates are needed in defining risks due to toxic chemicals.

    . Not funding at this level will inhibit the Agency's capability to
     carryout credible exposure estimates to be used in human  and environmental
     risk analysis
            008^

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                  ENVIRONMENTAL PROTECTION AGENCY

FORM  2:  DECISION UNIT LEVEL  ANALYSIS
A, DECISION  UNIT TITLE AND  CODE         HQ       MEDIAf TOX  SUB
L130  ECOLOGICAL EFFECTS                           APPRDt R  &  0
B. RESOURCE  SUMMARY       FY  78 ACT  FY 79 c.  E.  FY  *o INCR   FY  eo
         POSITIONS  PFT          7.0           9,0         10.0         27.0
 LEVEL              OPFT                        2.0           1.0          U,o
07 OF  06            FTE                       11.9           B . U         29.7
   BUDGET AUTH, (000,0)       550,0      1,692.0      fc , 000.0    13^025,0
   C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
     OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.

   Ecological Processes, 2M

   Activities;

     . The thrust of this  study is  to develop methods to predict
       bioaccumulation, degradation, and transformation of environmental
       contaminants  (toxic substances) in the food web.  Both laboratories  and
       field studies will  be used.  For example, soil will be treated  and used
       to grow three crop  types (legume, grain, root crop).  After analysis
       these crops will be fed to an insect, mammal, bird, or fish which will
       be analyzed.   Bioconcentration is evaluated on the basis of structure,
       physico-chemical properties, and biological degradation patterns,
       considering metabolism, bound residues and binding.  Carbon 14  labelled
       materials will be used from  chemical classes such as chlorinated
       aromatics, bolynuclear aromatics, organometallies and inorganics.
       Studies  will be expanded to include aquatic environments  so that inter-
       faces between air and water, soil and water, and air and soil can be
       evaluated. Studies undertaken will  draw upon existing information
       and data on the movement of  chemicals through environmental compartments
       In selecting  the species for the studies, emphasis will be on developing
       organisms for detecting the  presence of toxic materials in the  food  web
       that ultimately affect man.


   Impact;

     . Not funding would mean the Agency would have an inadequate data base
       for determining the potential for chemicals to reach man through the
       food web.   This information is needed for making regulatory decisions

     . Funding at this level would mean the Agency would take an  important  step
       in understanding the movement of chemicals through the food web which
       would enable  it to  better evaluate data for chemicals submitted for
       regulatory review and to give the Agency a much broader base of knowledge
       to make regulatory  decisions.
                                                                   0065
 EPA Form 2410-U (8-78)

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 FORM 2: DECISION UNIT LEVEL ANALYSIS
  A.  DECISION UNIT TITLE (AND CODE)

    Toxics-Ecological Effects (L130)
                    HQ  ORD

                    REG.
MEDIA. Toxics

APPRO: R&D
  B.  RESOURCE SUMMARY
FY 78 ACTUAL  FY 79 C. EST.   FY 80 INCR.
      FY 80 CUM
LEVEL
7 8
	 OF 	

POSITIONS PFT
OPFT
FTE



BUDGET AUTH. (OOO.O)L












  C.  DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY.  DESCRIBE THE BENEFITS
     OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.        -

  Exposure Measurement Field Studies,  6M

  Activities

   . Community exposure monitoring program will be mounted in three major urban
     areas to determine actual exposures to  pollutants of concern.   Use
     personal monitors in conjunction with other measurement  techniques to fully
     document the frequency distribution of  exposures  for a representative
     sample of the entire urban population.

  Impact

   . Funding at this level will provide support to developing the first
     statistically defensible characterization of ambient air exposures for an
     entire urban population.   High-risk subpopulations will  be identified.
     Changes in existing monitoring networks to better reflect human exposure
     will be recommended.  Models relating ambient air quality to exposure
     will be developed.  Dose data will become available  for  later or
     concurrent health effects studies to determine dose-response curves.

   . Not funding at this level will mean continued lack of data on exposure
     of populations; possible neglect of high-risk subpopulations;  suboptimal
     siting for stations with regard to human exposure; and lack of dose data
     for epidemiological purposes.
             OOGS
EPA. Form 2410-11 (3-73)

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                   ENVIRONMENTAL PROTECTION  AGENCY

FORM  21 DECISION!  UNIT LEVEL ANALYSTS
"•""<•••"•"••••••"•"•—•""••••••»••••»•»••••«•••••"•••••••••«•••.•••••••
A.  DECISION  UNIT  TITLE  AND CODE          HQ       *EDIA|  TDK SUB
L130  ECOLOGICAL  EFFECTS                            APPROf  R & 0
B, RESOURCE SUMMARY FY 78 ACT FY 79 c. E, FY

.LEVEL
POSITIONS

PFT
OPFT
7.0 9.0
2.0
60 INC" F
23.0

Y 80 CUM
50,0

.
08  OF  08             FTE                       n.9          19.1          48.6
    BUDGET  AUTH.  (000.0)       550.0      1,692.0      «, 000.0     17,025.0
  C.  DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
     OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.

  Activities

   .  Conduct research on individual processes, product  flows, and consumption to
     develop predictive models to identify anticipated  processes involved in
     manufacturing  commercial and consumer use, and disposal of toxic materials
     and to estimate the environment release to be  expected from these
     activities.

   .  Develop integrated exposure assessment models  utilizing the concept of
     environmental  and ecological processes, exposure monitoring research, and
     source term research.  Exposure models will be developed to predict
     concentration  of toxic chemicals in air,  water,  soil-sediments, and ground
     water.  Such models will be integrated to provide  information about human
     exposure through multi-media and the food chains.   Exposure models will be
     validated  and  exposure analysis will be carried  out on several toxics.

   .  Develop, environmental profile models for classes of toxic chemicals
     based on physical-chemical properties, environmental processes parameters,
     ecological process parameters, source term, and  toxicity data.  These
     models will be used to define major potential  environmental hazards
     associated with toxic substances.

   .  Evaluate and Improve methods for measuring individual exposure to ambient
     levels of  toxics in air.  Develop field-ready  personal dosimeters for
     three high-priority toxicants.

  Impact

   .  Funding at this level will provide a comprehensive exposure assessment
     model applicable to a variety of toxic chemicals, for estimating concen-
     tration of toxics in air,  surface water,  ground  water, soil-sediment,
     multimedia, and food chains.  These exposure estimates are needed in
     defining risk  to humans or the environment, caused by toxic chemicals.

   .  Funding at this level will provide the validated techniques necessary to
     determine  human exposure directly.
                                                                    0063
EPA Form 2410-11 (3-78)

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                      ENVIRONMENTAL PROTECTION AGENCY

FORM 2: DECISION UNIT LEVEL ANALYSIS
  A.  DECISION UNIT TITLE (AND CODE)
 Toxics Ecological Effects (L130)
                   HQ    ORD    MEDIA:  Toxics

                   REG.         APPRO:   R&D
  B.  RESOURCE SUMMARY
FY 78 ACTUAL  FY 79 C. EST.   FY 80 »NCR.
FY 80 CUM.
LEVEL
8 8
QP MM«

POSITIONS PFT
OPFT
FTE
BUDGET AUTH. (000.0)
















  C.  DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY.  DESCRIBE THE BENEFITS
     OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.


o  Not funding at this level will delay the development of credible risk
   asassment technology.

o  Not funding at this level will delay attainment of a personal exposure
   monitoring capability, which would be unresponsive to the concerns of
   Congress as expressed in the Authorizing Appropriations Report No. 95-985
   (p. 7).
              0070
EPA Form 2410-11 (8-78)

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-------
                     ENVIRONMENTAL PROTECTION AGENCY
FORM 1:  DECISION UNIT OVERVIEW
                                                               MEDIA: TOXICS  j

                                                               APPRO:  R&D
A) DECISION UNIT TITLE (AND CODE)

     Transport and Fate  (L135)
HQ  ORD

REG.
  B)  LONG RANGE GOALS & MAJOR OBJECTIVES

      Range Goals;   To  develop (1)  models for prediction of exposure concen-
 tration of toxic chemicals to air,  water,  soil/sediment,  food chain,  multi-
 media and humans, and (2)  improved  protocols for transport and fate of toxic
 chemicals.  This information is needed in  evaluating risk due to toxic
 chemicals under TSCA.

 lajor Objectives; Develop  methodologies for transport and fate processes,  to
 >e used in building and validating exposure assessment models for toxics  in
 multimedia environments; develop improved protocols for transport and fate
 to be used for testing of chemicals and predicting potential hazard due to
 toxic chemicals.
  C) FY 78 ACCOMPLISHMENTS             !

 '.. • Reports and papers on characterization and identification of environmental
     processes such as photolysis, oxidation, microbial degradation, adsorption
     volatilization as they relate to toxic chemicals in aquatic environments.

 2.  Report on exposure and ambienttconcentration of several synthetic organics
     in urban atmosphere at selected United States cities.

 3.  Report on the development of evaluative models to be used for toxic
     chemicals.
  D) FY 79 PROGRAM DESCRIPTION
 Activities:   Technical assistance to t)TS;  necessary transport and fate research
 to be used in exposure model development;  protocols for photolysis in air,
 adsorption and volatilization; development and validation of exposure models
 :or one class of toxics in multimedia,  preliminary studies on exposure models
 for toxics in humans and in the food chain. .

 'lannecl Accomplishments;  Reports on chemical  transformation of toxics in air,
 water and sediments;  protocols for photolysis, adsorption and volatilization,
 exposure models for one class of toxic chemicals in multimedia, and prelimi-
 nary models for toxics exposure in humans and food chain.

  lon'sidered Alternatives:  Work will involve a combination of extramural and
 Lnhouse effort.   All extramural or all inhouse alternatives were considered,
 >ut were not cost-effective.
                                                                      0073
 EPA Form 2410-10 (8-78)

-------
                  ENVIRONMENTAL PROIECTION  AGENCY
FORM  2s DECISION UNIT LEVEL  ANALYSIS
A, DECISION  UNIT TITLE AND  CODE
L135  TRANSPORT AND  FATE
                MO
MEDIAi  T.OX  stie
APPRPj  R &  D
B, RESOURCE  SUMMARY
         POSITIONS  PFT
 LEVEL              OPFT
01 OF  07            FTE
   BUDGET AUTH. (000,0)
FY 76  ACT FY  79 C.  t.
       6.0         11.0
                    2.0
                   13.«
     ^00.0      3,137.6
 FY  eo  INCR
         e.o
         2.0
        12.a
     1*603.2
FY 80  CUP
       8,0
       2.0
   C.  DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
      OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.

  Activities:  This base level program is  designed to meet the minimum needs
  in the area of exposure and  risk assessment and testing of toxic chemicals.
  This area is essential to the successful implementation of TSCA.

   o  Technical Assistance to  the  Office  of Toxic Substances (OTS).

   o  Development of multimedia exposure  models for toxic chemicals including
      •mass-balance, transfer coefficients, and model application to food chain.

   o  Development of models for human  exposure to toxic chemicals  and modi-
      fications to obtain improved predictive capability.

   o  Development of methods to investigate transformation of organic toxics
      in air including formation of additional toxic substances.

   o  Protocol development for photolysis of toxic chemicals on soils, sediments
      and plant surfaces and microcosms for testing of toxic chemicals.

   o  Determination of persistence and half-life of toxic chemicals in air.

  Impact;
    o  Funding at this base level will tenable the Agency to begin developing
      suitable predictive capability to be used in exposure assessment, and risk
      establishment process under TSCA.   The exposure level estimate is absolute
      essential in defining risk due to toxic chemicals.

    o  Funding at this level will provide  the Agency an in-house research and
      technical expertise to be used by OTS in solving complex technical
      problems in a reasonable time frame.

    o  Hot funding this level will seriously curtail the Agency's capability
      to determine environmental and human risks due to toxic substances.

    o  Not funding this level will delay the development of suitable testing
      protocols to be used in regulation  of toxic chemicals.
 EPA Form 2410-11 (8-78)

-------
f
                  ENVIRONMENTAL  PROTECTION AGENCY

    ^  2:  DECISION UNIT  LEVEL  ANALYSTS
 . DECISION  UNIT TITLE  AMD CODE
L135  TRANSPORT  AND FATE
HQ
                                                           f  TOX SU8
                                                     APPRO}  R & D
B. RESOURCE  SUMMARY       FY  78 ACT FY  7
-------
                  ENVIRONMENTAL PROTECTION' AGENCY

FORM  2:  DECISION UNIT LEVEL ANALYSIS

*, DECISION UNIT TITLE  AND CODE         HO       *LPIA|  T0x SUB    ---
L135  TRANSPORT  AND FATE                           APPRD|  R"& D

B. RESOURCE SUMMARY       ^Y 76 ACT  FY 79 C.  E.  FY  80  INCR    FY 80 CUM
         POSITIONS  PFT          6.0          11.0          1.0          11.0
 LEVEL              OPFT                        2.0                       2.0
03 OF  07            FTE                       13.9            5          13.9
   BUDGET AUTH,  (000.0)       "00.0      2,137.6        213.6      2,137.6
   C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY: DESCRIBE THE BENEFITS
     OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.


  Activities:
  o  Exposure analysis of selected toxic chemicals in multimedia environment
     and humans.

  o  Development  of methodologies to  investigate photolysis of toxics in air,.

  .o  Development  of methodologies to  determine microbial degradation mechanisms
     (anaerobic and aerobic) and protocols to be used in testing of toxic
     chemicals.                      '
                                    \

  Impact;
  o  Not funding this level will impede the progress of  regulatory function
     under TSCA, because the Agency would not be able to carryout multimedia
     exposure analysis.  Multimedia exposure data are essential to risk
     estimation.
         OU76
 EPA Form 2410-11 (8-78)

-------
                  ENVIRONMENTAL PROTECTION  AGENCY

      2s  DECISION UNIT  LEVEL ANALYSIS
 ; DECISION UMT TITLE  AND CODE         HQ       MEDIAf  TOX  SUB
1135  TRANSPORT  AND FATE                           APPRDj  R &  D
B, RESOURCE SUMMARY       FY 76  ACT  FY 79  C.  E,  FY  §0 INCR    FY 80  CUH
         POSITIONS  PFT           6.0          11.0          1.0         12.0
 LEVEL              OPFT                        2.0                        2.0
0« OF  07            FTE                       13.9          1.0         lfl.9
   BUDGET AUTH.  (000.0)       aoo.0      2,137.6        214.0      2,351.6
   C.  DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
      OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.
   Activity;   '                                                   •

   o  Characterization and selection of candidate sediment samples to represent
     the entire United States sediment profile for adsorption, leaching, and
     degradation testing.

   Impact;

   o  Funding at this  level will enable the Agency to carry out testing on only
     few sediments, thus minimizing the number of tests and resources for '
     testing.                         >              '      .

   o  Not funding this level will not provide refinement in the development of
     testing of chemicals, and it will be difficult to extrapolate results in
     various geographical locations.
                                       i T
                                                                    0077
 EPA Form 2410-11 (8-78)

-------
                                                  AGENCY
FORM  2;  DECISION
                             LEVEL  ANALYSIS
    A. DECISION  UNIT TITLE:  AND CODE
    L135  TRANSPORT  AND FATE
                                            HO
MEDIA|  TOX SUB
APPRPt  R * D
    8. RESOURCE  SUMMARY
             POSITIONS  PFT
     LEVEL              OPFT
    05 OF  07            FTE
       BUDGET AUTH.  (000.0)
FY 78  ACT FY  79 C. E.   FY
       6,0         11.0
                    2.0
                   13.9
    400.0      2,137,6
                                                              1.0

                                                              1.0
                                                              *.0
                FY 80  CUM
                      13.0
                       2.0
                      15.9
                  2,565.6
      C.  DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
         OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.
      Activities:
      o  Selection of Benchmark toxic chemicals,  development of a profile model
         for forecasting potential environmental  problems based on transport and
         fate profile, use pattern, emission of  discharge, and toxicity.

      >o  Improved methods for partition coefficient determination.
                   «
      Impact;                            :
      o  Funding at this level will result in the development of a system which
         vill provide indicators for environmental problems  (i.e., persistence,
         bioaccumulation)  before they arise, thus minimizing environmental risk.
         This work will also  lead to the development of a rapid screening system
         for toxics, thus  simplifying the process of regulation and saving in
         cost to the Agency.

      o  Not funding this  level will impede the development of adequate predictive
         capability for environmental transport and fate of chemicals.

                                         » T
             OUT8
     EPA Form 2410-11 (8-78)
T

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-------
                     ENVIRONMENTAL PROTECTION AGENCY
FORM 1:  DECISION UNIT OVERVIEW
 A)  DECISION UNIT TITLE (AND CODE)
      Testing and  Evaluation   (L  205)
HQ   OTS

REG.
MEDIA: Toxics

APPRO: A & C
  B)  LONG RANGE GOALS & MAJOR OBJECTIVES     The goals and objectives of Testing
 and  Evaluation all  aim  to  increase  efficiency and  scientific credibility of
 OTS  assessments and regulations.  They  are:  1)  to  develop a cost effective
 testing  scheme for  determining  experimentally the  health and environmental
 effects  of  chemicals; related to  this goal is the  annual review of all
 standards for  revision  as  necessary to  maintain an up-to-date and comprehen-
 sive scheme;   2)  to obtain test data where required for making evaluations of
 risk and assuring the quality of  data;  3)  to establish a mechanism for  identi-
 fying chemicals which deserve high  priority attention for further action such
 as assessment  or control;   4) to  develop a scientifically sound chemical
 assessment  system;  and  5)  to provide assessments of risk and exposure required
 to support  toxic substances control actions.


  C)  FY 78 ACCOMPLISHMENTS     The implementation of an hierarchical  testing
 scheme was  begun with the  development of 6 standards.  As the result of
 extensive evaluations,  testing  rule development was initiated for 21 chemicals
 or groups of chemicals,  18 of which were those  recommended by the Interagency
 Testing  Committee in which OTE  participated.  A 3-stage assessment
 process  was inaugurated  through which suspect chemicals are
 reviewed for hazard and  evaluations are made of potential risk of injury by
 hazardous chemicals to health and the environment: 35 early warning hazard
 assessments and 2 intermediate  were completed;  2 final assessments were
 initiated.  240 notices  from chemical manufacturers concerning substantial
 risk were evaluated.  A  quality assurance  standards document was developed
 through  final  draft (to  be proposed in  October).
  D)  FY 79 PROGRAM DESCRIPTION   The   activities  of  OTE  relate  to  implementing  th
 authority under  TSCA to  select chemicals  required to  be  tested  by  industry for
 their  possible health and  environmental effects.   OTE will develop a  series  of
 test standards which will  specify  the  protocols for each test,  data develop-
 ment,  analysis,  and  format for data submission, and good laboratory practices
 to be  observed.  These test standards  will be  applied to specific  chemicals/
 groups by Section  4  rules.  Chemicals  will be  selected on the basis of  semi-
 annual recommendations from the Interagency  Testing Committee,  a systematic
 selection process, and other  sources.  OTE plans  to have 13  test standards
 under  development  and to propose &/or  promulgate  12 additional.  The  planned
 number of chemicals  selected  for initial  test  rule development  is  60.   Promul-
 gated  rules  will require testing for 40 chemicals.
     OTE is  responsible  also  for hazard and  risk  evaluations which take a
 Variety  of forms.  Existing chemicals  identified  for  assessment will  go throug
 3  stages of  review:  OTE  plans that 92  early  warning assessments, 44 intermedi-
 ate, and 13  final  will be  completed.   Another  13  final assessments will be
 initiated.   At least 300 section 8(e)  notices  of  substantial risk  will  be
 evaluated.   OTE  will also  undertake assessments to support the  Premanufacture
 Review Division: 50  data evaluations,  34  control  screenings, and 24 risk
 assessments.
                                                                         oue.
EPA Form 2410-10 (8-78)

-------
                      ENVIRONMENTAL  PROTECTION  AGENCY
   FORM  H DECISION  UNIT  LEVEL  ANALYSIS
   A, DECISION  UNIT  TITLE  AND CODE         HQ        MEPIM  TOX
   L205  TESTING AND  EVALUATION                        APPRO:  A &  C
   B. RESOURCE  SUMMARY       pv  78 ACT  Fy 79  C. E.   F Yo
            POSITIONS   PFT          74.0         171.0         12R.O         128,0
    LEVEL               OPFT           4.0           9.0           9.0           9  0
   °1 OF  °9             FTE                       129.6         J62.3         162.3
      BUDGET  AUTM.  (000.0)     5,067.0     17,500.6     i^,B89,3      14,869.3
008
 C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
    OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.

 Activities

   Testing

      A major feature of the Toxic Substances Control  Act  (TSCA) is the
 authority to require industry to test selected chemicals  for  their
 possible adverse effects on health and the environment.   Adequate test
 data, which  are currently unavailable for most chemicals, are a pre-
 requisite to the evaluation of a chemical's risk.   Such evaluations are
 needed to define and implement appropriate regulatory actions  under TSCA
 and other statutes aimed at protecting health and  the environment.

      The testing authority of TSCA is implemented  by  the  promulgation of
 rules specifying the chemicals or categories of chemicals to  be tested
 and the "test  standards" which are to be followed  in  performing the testing.
 The test standards,  which TSCA requires to be reviewed and updated annually,
 specify the  effects  to be evaluated and the nature of the tests and test
 protocols to be followed in so doing.   In FY-79 OTE will  promulgate an
 initial structure of test standards (eight health  and four environmental)
 to be referenced in  adopting test rules for specific  chemicals and
 categories.  These initial standards will be based only on existing
 validated test  methods, and will not cover a number of important effects
 such as neurotoxicity and over-all ecosystem impacts.  At this level, OTE
 will be limited to a minimal program of maintaining and only  slightly
 expanding the FY-79  test standards base.  Two environmental test standards
 already proposed in  FY-79 will be promulgated and  four others  proposed
 and the annual  review of the test standards performed, but the usefulness
 of the latter will be dependent on the continuing  development  of improved
 and expanded test standards at higher  levels.   This level provides
 resources to continue FY-79 work on 13 test standards and to  initiate
 development  efforts  on 3 new standards.  This rate of new starts is about
 one-half that of FY-79.

      Promulgation of test rules applying the relevant test standards to
 specific chemicals will be done in response to the semi-annual recommenda-
 tions of the TSCA Interagency Testing  Committee (ITC)  established by
 Section 4(e) of TSCA, as well as for other chemicals  whose needs for testing
 have been identified through the evaluation process described below.  TSCA
 requires that within 12 months of receiving recommendations from the^ITC,
 EPA will either initiate rule making to require the recommended testing or
 publish its  reasons  for not so doing.   Each rule will encompass 10 or more
}chemicals or groups  of chemicals.  At  this level,  test rules
     EPA Form 2410-11 (8-78)

-------
                      ENVIRONMENTAL PROTECTION AGENCY
FORM 2:  DECISION UNIT LEVEL ANALYSIS
LEVEL
-i-OF-1
POSITIONS PFT
OPFT
FTE
BUDGET AUTH. (000.0)
















  A.  DECISION UNIT TITLE (AND CODE)

            Testing and Evaluation (L205)
                   HQ OTS

                   REG.
MEDIA: Toxics

APPRO: A and c
  B.  RESOURCE SUMMARY
FY 78 ACTUAL  FY 79 C. EST.   FY 80 INCR.
      FY80CUM.
  C.  DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
     OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.

 Level 1 of 9 (continued)
 will be promulgated for approximately 20 chemicals recommended by the
 ITC in FY 79 and 30 coming through the FY79 chemical evaluation efforts.
 Test rule development will be initiated for approximately 30 chemicals
 identified in FY-80.

 Evaluation
      Evaluating the hazards associated with production, use, and disposal
 of chemicals to determine if such activities pose unreasonable risks is
 the cornerstone of the TSCA program.  Certain evaluation efforts, such
 as evaluating "notices of substantial risk" submitted by industry as
 required by Section 8(e), evaluating citizen petitions submitted under
 Section 21, and evaluating notices submitted by industry prior to the
 manufacture of a new chemical as required by Section 5 are essentially
 non-discretionary.  Other evaluation activities, such as systematic
 identification and assessment of potentially high-risk existing or new
 chemicals, are critical to the effective application of TSCA regulatory
 authorities.

      Chemicals of concern identified through review of Section 8(e)
 notifications and other sources will be entered into a three-stage
 evaluation process, with a decision being made at the end of each stage
 whether to continue on to the next, more intensive stage of evaluation.
 Alternate decisions at a given stage include dropping current consideration
 because of apparent low hazard potential, subjecting the chemical to
 testing requirements to fill critical data gaps, or referring the chemical
 to another program or agency having authority to deal with any apparent
 hazards.  Chemicals having completed all three evaluation stages will
 have received a full evaluation of their sources, exposure potential,
 and adverse effects, as well as an investigation of their existing
 regulatory controls and identification of possible control options to
 reduce health and/or environmental risks associated with their production,
 use, and disposal.  Such evaluations will provide a basis for initiating
 suitable regulatory actions under TSCA or other relevant authorities.

      This level provides resources only for continuation of select
 assessments initiated in FY-79, followup evaluations based on chemicals
 identified through Section 8(e) risk notifications as needed, and limited
 hazard/risk evaluation activities in support of other program efforts Q(JŁ5
 such as the Section 5 premanufacture notice review program.
EPA Form 2410-11 (8-78)

-------
                     ENVIRONMENTAL PROTECTION AGENCY

FORM 2:  DECISION UNIT LEVEL ANALYSIS
  A.  DECISION UNIT TITLE (AND CODE)

     Testing and Evaluation (L205)
                   HQ

                   REG.
OTS
MEDIA. Toxics
APPRO: A  and C
  B.  RESOURCE SUMMARY
FY 78 ACTUAL  FY 79 C. EST.   FY 80 INCR.
              FY80CUM.
1 LEVEL 9
. 	 OF 	

POSITIONS PFT
OPFT
FTE
BUDGET AUTH. (000.0)
















  C.  DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
     OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.
   Impact

        Funding this  base level  provides  quality  assurance  oE  the  limited
   test  standards  system in place  and  accomplishes non-discretionary  tasks
   in testing  and  evaluation required  by  TSCA.  On approximately 50 chemicals,
   OTE will receive consistent submissions  of  test data  and more valid
   data  from industry to make more sound  regulatory  decisions.

        Not funding this level would prevent implementation of  TSCA Section A
   Testing and eliminate the chemical  evaluation  efforts necessary to
   followup on Section 8(e) notices and Section 21 petitions.
       CJU8S
EPA Form 2410-11 (8-78)

-------
                   ENVIRONMENTAL  PROTECTION  AGENCY

FORM  as DECISION UNIT  LEVEL  ANALYSIS
  *" *"*•*•• V 4V •» V ™ *• »••<••• ™ •* • * W*WWWWWP*WW V • • • VR V) • Ml V flk • • •§ • 9 W Ml M1 • • 4R • •• M* ••§•••• • V • W 9 W W
A, DECISION UNIT TITLE AND CODE         HO       MŁUIAj TOX SU8
L205  TESTING AND EVALUATION                        APPRDj A i C~

B, RESOURCE SUMMARY       FY  7B ACT  FY 79  C. E.   FY 60 INCR    FY 80 CUM
         POSITIONS  PM         7«,0         171.C          ?6.0         154.0
 LEVEL              OPFT          «.0           9.0           2,0          11.0
02 OF 09             FTE                      129.6          15.9         176.2
   BUDGET AUTH.  (000.0)    5,067.0     17,500.6      5,339.3     20,238.5
     C  DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
        OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.

    Activities
      Testing

         At this  level, development of three additional test standards (one
    health and  two  environmental) would be initiated and 10 additional chemicals
    would enter the test rule development process.

      Evaluation

         In addition to responding to non-discretionary situations -regarding
    high-risk chemicals, OTE would conduct its  own systematic identification
    and  evaluation  of potential high-risk chemicals (but only at a level  one-
    half of that  planned for FY-79).   As the result of identifying 200 high-risk
    chemicals,  OTE  would increase the number of completed hazard assessments by
    29.   The quality of screening of  Section 8(e) Substantial Risk notices
    wouldimprove  from cursory to adequate.   OTE would double the scientific
    support to  Section 5:  Premanufacture Review, although the quality of the
    evaluations would remain superficial.

      Impact

         — Funding this level will improve the test standards base with  the
    additional  test standards and, therefore, broaden the range of data on
    which regulatory decisions are made.   Also, this level, in allowing OTE
    to initiate systematic evaluation of existing chemicals, gives EPA some
    share in determining future TSCA  chemical control actions.  Further,  this
    level,  in improving the quality of evaluations of 8(e) Substantial Risk
    notices, increases confidence in  policy and decisions regarding the chemicals
    in question and enhances EPA's scientific credibility.

         — Not funding this level would result in inadequate evaluations of
    Section 8(e)  Substantial Risk notices with the possible consequence of
    severe criticism of EPA for failing to act on a hazard pointed out by
    industry in such a notice.   Not funding at this level would also leave  the
    OTS  evaluation efforts totally driven by external inputs, quite probably
    leading to  failure to identify and evaluate hazardous chemical and the
    associated  risks not already receiving  attention by others.

                                                                     0087
   EPA Form 2410-11 (8-78)

-------
FORM
                   ENVIRONMENTAL.  PROTECTION AGENCY
         DECISION  UNIT LEVEL ANALYSIS
A,  DECISION  UNIT  TITLE  AND CODE
L205  TESTING AND  EVALUATION
                                             MO
          MEDIAi TOX SUB
          APPR(i| A  & C
B,  RESOURCE  SUMMARY
         POSITIONS   PFT
 LEVEL              OPFT
03  OF  09             FTE
    BUDGET  AUTH.  fOOO.O)
                             FY 78  ACT FY  79 C.  E,
                                  74.C        171.0
                                    4.0          9.0
                               5,067.0
17,500.8
    INCR
    17,0
     1.0
     9.9
2,204,4
FY  80 CUM
     171.0
      12.0
     188.1
 22,442.9
     C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
        OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.


         Activities

             At this level, all resources would be assigned  to strengthen
         evaluation activities.   OTE would increase the risk  evaluation
         support to the Section  5:  Premanufacture Review Program to meet
         its needs at this level, providing 14 additional assessments.
         Because the increase in work years required by the Section 5 program
         is 38% over the amount  allocated for FY 79, other OTE activities at
         this level remain below the FY 79 base despite some  increase.  OTE
         would identify an additional 19 high risk chemicals  and complete
         2  Early Warning hazard  assessments.
         Impact

             — Funding this level assures a sound scientific  evaluation of
         the data submitted by manufacturers on new chemicals or new uses of
         existing chemicals prior to  their introduction into commerce.  Such
         evaluations provide the basis for subsequent decisions concerning
         the need for health and environmental effects testing  and control of
         the chemicals in question.

             — Not funding this level would jeopardize the effectiveness of
         Section 5 premanufacture review program and, thereby,  subvert a
         major intention of TSCA to anticipate potential hazards to health
         and the environment by  evaluating chemicals prior to  manufacture.
           QQ88
    EPA Form 2470-]] (8-78)

-------
                   ENVIRONMENTAL PROTECTION AGENCY

FORM  2{ DECISION UNIT  LEVEL  ANALYSIS
         	        ^ ^  ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ M- M ^ ^ ^ ^ M ^ M ^ ^ M M M • M M M A M A ^ ^ • • • M M M IB •§ • M •• IB flp •
HI W • • •§ •• • W ^ •• W • •§ PJ IP iP W V W 1* • IP ipi IP IP » •• W ^ ^ MR ^ » ^ IP ^ IV •» ^ ^ ^ ^ PP ^ ^ ^ ^^^w^»-^^ ^ ^ ^ •"• ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^
A. DECISION UNIT TITLE ANl?  CODE          HO       MEDIAj TOX SU«
L205  TESTING AND EVALUATION                        APPR()J A  & C
OT •* Pt ••••IWW^PWW • • •* V * • • • ^ ^ • •* •* •* • W • <• • V P* •* •• ^ •* W V ** W W * • •* •• W w ™ 9 P* • ^ •• * • • P» P* W ^ w P* ^ ^ ^ • 9 W W ^
B, RESOURCE SUMMARY       FY  78 ACT FY  79 c.  E.  FY eo INCR    FY so  CUM
         POSITIONS  PFT         7a.O        171,0                      171.0
 LEVEL              OPFT          d.O          9.0                        12.1)
04 OF 09             FTE                      129.6                      188.1
   BUDGET  AUTH. (000.0)     5*067.0     17,500.8      3,6A2.0     26,124,9
     C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
        OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.

    Activities
         All the incremental funds at  this  level would be spent for extra-
    mural contracts that would assist  staff to  increase the accomplishments to
    approximate those of FY 79.

    Evaluation

         This level of funding would increase by 181 the number of potential
    high-risk chemicals selected by OTE  for systematic identification and
    evaluation.  (Although this level  of the selection activity would then
    match that of FY 79, it represents only a small fraction of suspect
    chemicals.)  Early warning and intermediate hazard assessments would increase
    22 and 2 respectively to match the numbers  of each completed in FY 79;
    however, the number of final assessments remains below that targeted for
    FY 79 since the FY 79 program will be working on a backlog of evaluations
    from FY 78.  (Expanded selection and early  evaluation activities would be
    required to maintain the FY 79 output levels over time.)

    Testing

         In response to the expanded chemical evaluation activity, approximately
    20 potential high-risk chemicals would  be identified for which test data
    are required to make the final determination of risk;  they would enter
    the test rule development process.  This activity would match that of FY 79.
    In addition, development efforts would  begin for 3 more test standards
    needed to fill out the test standards system.

    Impact
         — Funding this level would maintain  the flow of activities that would
    almost match that of FY 79, and, therefore,  continue the implementation
    of the Toxic Substances Control Act.

         — Not funding this level would  reduce  the chemical evaluation program
    to below its FY 79 level.   This reduction  would cause a substantial loss
    of outputs in the form of identified  and documented chemical control needs
    in FY 81 and beyond as well as in FY  80.

                                                                     OU89
   EPA Form 2410-11 (8-78)

-------
                  ENVIRONMENTAL PROTECTION AGEK'CV

FORM  2: DECISin?<  UNIT LEVEL ANALYSIS
A, DECISION  UNIT  TITLE AND CODE
L205  TESTING AND  EVALUATION
              HP
                              ftj TQX  SUB
                         APPROt A  &  C
B, RESOURCE  SUMMARY
         POSITIONS   PFT
 LEVEL              OPFT
05 OF  09             FTE
   BUDGET  AUTH.  (000.0)
f-Y 78  ACT FY  79 C,  E.
      7^.0        171.0
                            80
5,067,0
                   129.6
               17,500.6
                               17.0
                                1,0
                               15.5
FY 80  CUM
     186.0
      13.0
     203.6
 27,688.1
     C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
       OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.
        Activities

             Expanded  activities of the Section 5 premanufacture  review
        program for  new chemicals at this  level necessitate additional OTE
        support in the form of evaluation  of  submissions on chemicals
        tentatively  identified as candidates  for further action under
        Section 5.  OTE would conduct 51 data evaluations, 44 control
        screenings,  and 27 risk assessments.

        Impact

             — Funding this level assures sound scientific evaluation of the
        data submitted by manufacturers on new chemicals or new uses of
        existing chemicals prior to their  introduction into commerce.  Such
        evaluations  provide the basis for  subsequent decisions concerning
        testing and  control of the chemicals  in question.

             — Not  funding this level would  jeopardize the effectiveness
        of Section 5 premanufacture review program and, thereby,  subvert
        a major intention of TSCA to anticipate potential hazards.
          OUBO
   EPA Form 2410-11 (8-78)

-------
                  ENVIRONMENTAL  PROTECTION AGENCY
 ORM  2?  DECISION UNIT  LEVEL  ANALYSIS
A, DECISION  UNIT TITLE AND  CODE
L20S  TESTING  AND EVALUATION
                HQ
MEDIA!  TOX  SUB
APPRO?  ARC
B, RESOURCE  SUMMARY
         POSITIONS  PFT
 LEVEL              OPFT
06 OF  09            FTE
   BUDGET AUTH. (000.0)
FY 76  ACT FY  79 C. E.
     74.0        171.0
       4.0          9.0
                  129.6
  5/067.C     17,500.6
FY
     PO  IMCR
        17.0
         1.0
        15.7
     1.631.2
FY 60  CUM
     205.0
      1«.0
     219.3
 29,319.3
     C.  DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
        OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.


        Activities

             Expanded activities of the Section 5 premanufacture review
        program for  new chemicals at this  level necessitate additional OTE
        support.   OTE would conduct 51 data evaluations,  24 control  screenings,
        and 50 risk  assessments.
        Impact

             — Funding this level assures sound scientific evaluation of the
        data submitted by manufacturers on new chemicals prior to their
        introduction  into commerce.   Such evaluations  provide the basis for
        subsequent decisions concerning the new chemicals in question.

             — Not funding this level would jeopardize the effectiveness of
        Section 5 premanufacture review program and, thereby, subvert  a
        major intention of TSCA to anticipate potential hazards to health
        and the environment.
                                                                   0031
   EPA Form 2410-11 (8-78)

-------
                   ENVIRONMENTAL  PROTECTION  AGENCY
FORM  2: DECISION  UNIT LEVEL ANALYSIS
A, DECISION  UNIT  TITLE  AND CODE          HG       MfcniAt  TOX SUB
L205  TESTING AND  EVALUATION                       APPRO*  A  & C

B, RESOURCE  SUMMARY       FY 78  ACT FY 79 c.  E.   FY *
-------
                   ENVIRONMENTAL PROTECTION AGENCY
FORM  2: DECISION UNIT  LEVEL  ANALYSIS
A,  DECISION UNIT  TITLE  AND  CODE          HQ       MtDJAf TO*  SUB
L?05  TESTING AND  EVALUATION                        APPRO} A  &  C

B.  RESOURCE SUMMARY       FY  76 ACT  FY  79 C. E.   FY  1*0 INCR   FY  80
         POSITIONS  PFT          74.0         171.0          35.0
 LEVEL              OPFT           4.0           9.0           2.0          19,0
08  OF 09             FTE                       1?9.6          32.1        283,9
    BUDGET  AUTH.  (000.0)      5,067.0      17,500.8       4,122,0     40,7e>7,l
     C.  DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
        OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING,

    Activities
      Testing

         At this level,  development of three additional test standards would
    be initiated for use in  updating the system of test standards.  Work would
    also begin on one additional  test rule covering approximately  10  existing
    chemicals or categories.

      Evaluation

         113 potential high-risk  existing chemicals would enter  the systematic
    identification and evaluation process.  This expansion would allow the
    conduct of 16 hazard assessments.

         Technical support to  the premanufacture review program  will  again be
    expanded at this level to  meet the increased need for such support by the
    Premanufacturing Review  Division's more thorough program at  Level 7.  27
    risk assessments would be  conducted.  Resources for 32 literature searches
    and two monitoring efforts to support these additional assessments and
    testing activities are included in this level.*

      Impact

         — Funding this level provides the resources necessary  to expand the
    evaluation of existing chemicals to a level assuring future  growth in
    regulation of existing chemicals.  It also provides the ability to keep
    the test standards system  current with the state-of-the-art, a necessity
    to provide data as accurate as possible and protect against  litigation
    relating to the Section  4  requirements.  The funding would allow  an
    increase in the number of  thorough risk assessments of new chemicals with
    the likelihood of identifying potential hazards that might slip through
    initial screenings.

         — Not funding  this level prevents future growth in control  activities
    since the evaluations required to initiate such activities would  be limited
    to the FY-79 output  level.  Not funding would relegate the test standards
    system to become outmoded  and, therefore, jeopardize the Section  4 required
    testing program as well  as subject the Agency to litigation  for failure to
    provide the protection intended by TSCA.
         * These Information Integration support activities  are  included
    adjustment to account for the effects of ranking.
   EPA Form 2410-11 (8-78)

-------
                   ENVIRONMENTAL PROTECTION AGENCY

FORM  2t r>ŁclSION UNIT  LEVEL  ANALYSIS
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-------
                  ENVIRONMENTAL PROTECTION AGENCY

FORM 1:  DECISION UNIT OVERVIEW
 A) DECISION UNIT TITLE (AND CODE)                 HO QTS    MEDIA:Toxics

    CHEMICAL CONTROL   (L210)                   REG.       APPRO:A  &  C
  B) LONG RANGE GOALS & MAJOR OBJECTIVES
   The  goal  of  chemical  control is to protect human health  and
  the environment  by  controlling new and existing chemical
  substances  that  present  unreasonable risks of injury to health
  or the environment.   This  goal will be accomplished through
  implementation of  the premanufacturing notification, control
  regulations, and imminent  hazard regulatory provisions of  the
  Toxic  Substances Control Act (TSCA).  The major objectives are:
  determination  of unreasonable risk based upon evaluation of
  chemical  substances  on  health, environmental, social, and
  economic  factors; use of the least burdensome type of control
  (regulatory or nonregulatory) necessary to reduce or prevent
  unreasonable risk;  and  provision of all the economic analysis
  necessary to implement TSCA.
  C) FY 78 ACCOMPLISHMENTS

   A program is being  developed for the implementation of the
  premanufacture review section of TSCA (§5).  The regulation
  interpreting section 5, the  premanufacture notice form, and the
  supporting documents  will  be proposed in the Federal Register by
  the end of FY  78.                             ~~~
   For existing chemicals (§6), two regulations were promulgated.
 The two were the marking and dispoal rule on polychlorinated
 biphenyls and  the ban on chlorofluorocarbons in aerosol
 containers.   A proposed regulation banning uses of polychlori-
 nated biphenyls was  proposed.

                            -- Continued on attached sheet --
  D) FY 79 PROGRAM DESCRIPTION

   Regulations  and guidelines will be established for the con-
 tents of  premanufacture notices  and all of the 200 notices
 expected  to be received will be  reviewed for compliance and
 initially screened for hazard based on the notice data.  Effects
 and exposure data in  each  notice will be screened and selected
 chemicals subjected  to further scrutiny.  Notices which do not
 comply or which have  insufficient data will be reviewed for a
 possible  prohibition  or limitation order pending development of
 additional information and two of these actions will be taken.
 For some  chemicals,  information  to supplement the notice data
 review will be obtained from 20  searches of in-house data
 systems and  from 18  letters  sent to manufacturers requesting
 information on production, effects,  exposure,  and health and
 safety studies.  Complete  assessment packages will be prepared
 for eight chemicals  based  on notice data,  supplementary
 information, and risk assessments from the Office of Testing and
 Evaluation.   If an unreasonable  risk is determined to exist,  an
 injunction or  administrative  order banning or controlling the
 chemical will  be
EPA Form 2410-10 (8-78)

-------
                       ENVIRONMENTAL PROTECTION AGENCY

     FORM 1:  DECISION UNIT OVERVIEW
      A)  DECISION UNIT TITLE (AND CODE)
         CHEMICAL CONTROL      (L210)
                                            HQ

                                            REG
MEU«A:Toxics

APPRO: A & C
010
       B) LONG RANGE GOALS & MAJOR OBJECTIVES
       C) FY 78 ACCOMPLISHMENTS

         Economic analysis  was  provided to support  the  inventory
      lation, the three  regulations on existing chemicals  listed
      above, and to  the  development of the premanufacture  review
      program.
                                                             regu-
                                                                     an
 D)  FY 79 PROGRAM DESCRIPTION
issued  within the notice period.  It  is  expected  that one of
these actions will be taken in FY 1979.   Two  chemicals, which
are  found  to  pose significant risks but  on  which  action cannot
be  taken within the time constraints, will  be  referred after
expiration of the notice period for formal  control action on
expedited  schedule.
  A  few chemicals which do not warrant immediate  controls, but
which might  in  the future (e.g., if exposure were  to increase),
will be the  subject of significant new use  rules  or a rule
requiring  reporting of specific information in  order to indicate
the  need for  eventual control action.  Significant new use rules
may  also be  developed to apply to existing  chemicals if a change
in  their use  occurred which would significantly increase
exposure.  Manufacturers and processors  would then be required
to notify  EPA.   Two significant new use  rules and  reporting
rules on three  chemicals will be developed.
  Arrangements  will be made to provide to other offices or
agencies information  received in premanufacture notices, which
would be useful  to those other programs.   In addition,  six
chemicals  which  are determined to be high risks but more
     EPA Form 2410-10 (8-78)

-------
                  ENVIRONMENTAL PROTECTION AGENCY

FORM1:  DECISION UNIT OVERVIEW
  A) DECISION UNIT TITLE (AND CODE)                  HO.  OTS     MEDIA:Toxics

    CHEMICAL CONTROL  L 210                     REG.       APPRO: A & C
  B) LONG RANGE GOALS & MAJOR OBJECTIVES
  C) FY 78 ACCOMPLISHMENTS
  D) FY 79 PROGRAM DESCRIPTION
 appropriately  controllable under other authorities,  will be
 referred to  other  programs for action.  Six  informal attempts
 will be made to  persuade  manufacturers to  voluntarily restrict
 exposure and reduce  risks as an alternative  to  formal EPA
 action.
   For existing chemicals, final rules regarding  the  TSCA bans on
 the manufacture, processing, distribution, and  use  of PCBs will
 be published,  plans  will  be developed to deal with  the disposal
 of small PCB capacitors,  nonaerosol uses of  chlorofluorocarbons
 will be addressed, generic labeling regulations  will be
 proposed, final  action  will be taken on PBBs, and  the regulatory
 process will be  initiated on eleven chemicals,  two  of which are
 expected to  be referrals  from premanufacturing  review for
 expedited control  action.
   In addition  to regulatory activities,  Control  Action will
 develop regulatory procedures to permit implementation of other
 provisions of TSCA.   Procedures will be developed  to issue
 quality control  orders  (used when a manufacturer or  processor is
 producing a  chemical  or article with an undesirable  contaminant)
 and to  deal  with imminent hazards (section 7).

                                                 	        run
EPA Form 2410.10 (8.78)

-------
                  ENVIRONMENTAL PROTECTION AGENCY

FORM 1:  DECISION UNIT OVERVIEW
 A) DECISION UNIT TITLE 
-------
                 ENVIRONMENTAL PROTECTION AGENCY

FORM 2? DECISION  UNIT  LEVEL ANALYSIS
A. DECISION UNIT  TITLE  AND CODE        HQ       MEDIAj  TOX SUB
L210 CHEMICAL CONTROL                            APPROj  A  & c"

B. RESOURCE SUMMARY       FY 78 ACT FY 79*0. "g.   Fv"Bo"lNCR*""FY*flo
        POSITIONS  PFT         42,0       117.0         es.o        ee.o
                   OPFT          1.0         6.0         6.0         60
01 of (">           FTE                    113. i        m  i       ni;J
   BUDGET AUTH. (000.0)     1,5«8.0     7,987.0      «,539.«     4,539 fl
     C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
       OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.

        The functions  of  the  Chemical  Control  Decision Unit are  to
    assess notices and  information  regarding the manufacture  of  new
    chemicals (i.e., those  not  listed  in the inventory of existing
    chemicals) and the  manufacture  or  processing of chemicals  for
    significant new uses;  to  review  information on the hazards of
    existing chemicals  (those  listed in the inventory); to limit or
    control by injunction,  order,  or formal rulemaking the
    manufacturing, processing,  distribution, use, or disposal  of
    chemicals which pose  or may pose unreasonable risks to health
    or the environment.   Additional  functions  are to conduct
    economic studies to  support these  actions  as well as  testing
    and evaluation, reporting,  and  recordkeeping.

    ACTIVITIES
    Premanufacture Review
        All of the anticipated  400  premanufacture notices will  be
    subject to cursory  review  to  check on compliance with rules and
    guidelines and to verify  that the subject chemical or use  is
    "new" as defined by  EPA.   The required official record will be
    established and maintained  and  exemption requests will be
    reviewed and subsequently  granted or denied.  (These functions
    amount merely to "opening  the mail").  The notices will  be
    subject to preliminary  risk assessments which will be of  a  very
    cursory nature based solely on  health and environmental  effects
    and exposure data derived  from  notice data.  Additional  infor-
    mation will be gathered for review of a limited number of
    selected chemicals  determined to have only the very highest
    risk potential, i.e.,  in-house  data systems will be searched
    and letters will be  sent  requesting information on effects  and
    exposure and health  and safety  studies for 7 percent of  the
    notices at most.  No complete assessments will be done to
    support any control  actions under TSCA; the additional infor-
    mation will be used  to  determine appropriate agencies/programs
    to which 2 percent  of the  chemicals will be referred and  to
    attempt informal control  on 1 percent of the chemicals through
    jawboning.  These approaches  are used at this constrained  level
    of resources in order to  effect the most potential control  in
    the least resource  intensive  manner possible.  However,  there
    can be no assurance  that  either of these actions will result  in
    any reduction of risk.   EPA will take no regulatory control  i')1 f
   EPA Form 2410-11 (8-78)

-------
                    ENVIRONMENTAL PROTECTION AGENCY
  FORM 2:  DECISION UNIT LEVEL ANALYSIS
   A.  DECISION UNIT TITLE (AND CODE)

      CHEMICAL CONTROL L210
                                          HQ OTS

                                          REG.
MEDIA: Toxics

APPRO: A  &  C
   B.  RESOURCE SUMMARY
                          FY 78 ACTUAL  FY 79 C. EST.  FY 80 INCR.
     FY 80 CUM.
LEVEL
— 1— OF— •* —
POSITIONS PFT
OPFT
FTE
BUDGET AUTH. (000.0)
















   C.  DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
      OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.
    action of  any  kind  on  new  chemicals.  As a result, the major
    preventive public health program the  Agency administers will be
    ineffectual  in achieving its  purpose.

    Control Action

        It will  not be  possible  to  continue all of the regulatory
    actions initiated during or  prior to  FY 79.  Of the 7 actions
    initiated  and  4 actions  underway on  existing chemicals at  the
    end of FY  79,  5 will  be  proposed during FY 80; 3 of these  will
    be promulgated along  with  3  others which were proposed in  FY
    79.   It will also be  impossible  to consider starting  any work
    on any regulations  on  existing  chemical hazards referred for
    control in FY  80 by Testing  and  Evaluation.

    Economics

        Economic studies  would be continued on laboratory
    availability from FY  79  and  would be  conducted in support  of
    testing  rules, risk assessment  reports, premanufacture review
    guideline  development, the proposed  regulations for chemical
    control, and recordkeeping or reporting rules produced at  Level
    1 in  FY  80 of  each  of  these  programs  as required by TSCA.

    IMPACT
o:.
       Funding at this level would implement  a  notice  processing
  program,  provide limited additional information  with which to
  assess premanufacture notices and to increase the  data base to
  be used for future control actions, and  inform the public of
  proposals to manufacture new chemicals;  2 percent  of the
  chemicals might be controlled under other authorities thereby
  possibly  providing some protection to health  or  the  environment
  from some of the highest risk chemicals  before the public is
  exposed to them; continuation of some regulatory actions
  already underway would be possible, reducing  slightly the risk
  already imposed by existing chemicals.

      Not funding this level would prevent EPA  from  implementing
  a premanufacture notice program and considering  risk associated
  with manufacture of chemicals for which  notices  are  received,
  and would prevent any action by OTS under section  5, 6, or 7 of
f,|TSCA, including those begun in previous  years.
  EPA Form 2410-11 (8-78)

-------
                 ENVIRONMENTAL PROTECTION  AGENCY

FORM as DECISION UNIT  LEVEL ANALYSIS
»mmmmmmmmmm»m»tmmm»mm»mmmmi»mmmmmmmmm*mmmmm + »m*immi
A. DECISION  UMT TITLE ANU CODE        HQ
L210 CHEMICAL  CONTROL
                                                     M TOX SUB
                                                 APFRP; A & C
B. RESOURCE  SUMMARY
        POSITIONS  PFT
 LEVEL             OPFT
02 of 09           FTE
   BUDGET AUTH.  (000.0)
                          FY 78 ACT FY 79 C.  E,
                               «2.0       117.0
                                1,0          6.0
                                          113,1
                                  0     7,987,0
FY
 INCR
 17,0
  1.0
  9.9
637,9
FY 60 CUM
    105.0
      7.0
    121,0
  5,177.3
     C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
       OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.

     ACTIVITIES

     Premanufacture Review

         At this level,  the  first  formal control of a new  chemical
     will occur.  However,  taking  action on only 0.25 percent of the
     total notices  will  provide  almost negligible preventative
     public health  protection.   Efforts  to acquire information  on
     suspect chemicals will  be  slightly  increased through  data
     systems searches  and  letters  requesting exposure and  effects
     data and health and  safety  studies  to include a maximum  of  9
     percent of the premanufacture notices.  The chemical  with  the
     greatest potential  for  adverse effects and substantial  exposure
     will be selected  and  regulated based  on complete assessments.
     Informal control  actions will be  attempted on a few additional
     new chemicals.  Only  two referrals  will be made to  other
     programs as emphasis  on  direct action will have begun  slightly.

     Control Action
         Rules on new chemicals  begun in previous years will  be
     completed and one additional  proposed, and plans will  be
     considered for regulating  existing chemicals for which a final
     risk assessment is  received from Testing and Evaluation. The
     program continues to  be  limited to completing action  from
     previous years rather  than  responding to new referrals.

     Economic s

         Economic reports  necessary for orders or injunctions in
     response to premanufacture  notices and chemical regulations
     will be done as mandated  to support Level 2 of  these  programs.

     IMPACT

         Funding at this level  would provide somewhat more  complete
     data on which to provide  a  greater degree of review and
     screening of premanufacture notices and thereby slightly
     improve the quality of decisionmaking and subsequent  actions.
     EPA could begin an  extremely  limited regulatory control  program
     in response to premanufacture notices which would provide very

                                                                  0115
   EPA Form 2410-11 (8-78)

-------
                   ENVIRONMENTAL PROTECTION AGENCY

FORM 2:  DECISION UNIT LEVEL ANALYSIS
  A. DECISION UNIT TITLE (AND CODE)

    CHEMICAL CONTROL  (L210)
                 HQ   OTS

                 REG.
MEDIA: Toxics

APPRO: A &C
  B. RESOURCE SUMMARY
FY 78 ACTUAL  FY 79 C. EST.   FY 80 INCR.
      FY80CUM.
•LEVEL
JL_0F^
(continued)
POSITIONS PFT
OPFT
. . FTE
BUDGET AUTH. (000.0)
















  C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
    OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.

   marginal protection from risk  before exposure.   Additional
   information acquired would contribute to the  data base  for  use
   in  future control  actions.  The  Agency could  complete another
   regulation  on an  existing chemical hazard begun in FY 79  which
   would slightly  increase the Agency's credibility on response to
   clearly known hazards at least.

       Not funding at  this level  would  mean absolutely no  direct
   control of  any newly manufactured  chemical  in the United
   States; any control would be dependent on action by programs to
   which chemicals might be referred.  A direct  major thrust of
   the Toxic Substances Control Act--prevent ion  of exposure  to
   hazardous substances before  introduction into the environment--
   would not be  implemented.  No  resources would be available  for
   response to newly  identified chemical hazards during FY 80  and
   only  some of  the  regulations initiated in FY  79 would be
   promulga ted.
      OILS
EPA Form 2410-11 (8-78)

-------
                 ENVIRONMENTAL PROTECTION  AGENCY
FOR* 2: DECISION  UNIT  LEVEL ANALYSIS
A, DECISION  UNIT  TITLE  AND CODE        HO       MtOIM  TOX SUB
L210 CHEMICAL  CONTROL                            APPRdt  A  & C
B, RESOURCE SUMMARY       FY 76 ACT FY 79 C. E.   FY  PO  INCR   FY 80
 • run   PUSITI°NS  n^T         ^-°       I"."         12.0       uT.'o
 LEVEL             OPFT          i.o         bio          i.o         e o
°* OP 09           FTE                    M3  ,          }  fl         I °
   BULGET AUTH.  (000.0)     1,546.0     7,987.0      J,523.0     6,700^
    C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
      OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.

     ACTIVITIES

     Premanufacture  Review

         Additional  data systems searches,  letter  requests for
     effects and exposure information,  and  health  and  safety studies
     will  supplement review of data for up  to  11 percent  of  the
     total  notices  received.  Compared  to the  FY 79  program, this
     level  will  provide only about one-half of  the minimal data base
     required  to make subsequent decisions  for  action  on  this number
     of  notices.   With this information, complete  assessments of new
     chemicals will  be done to determine the need  for  action on
     slightly  less  than 2 percent of the total  notices received.
     One additional  chemical will be subject to an order  or
     injunction  to  control its manufacture, processing,
     distribution,  use, or disposal.  Another  two  chemicals  will be
     subject  to  referral to other programs  or  informal control
     action.   Nevertheless, action on only  0.5  percent of the
     notices  received will not prevent  much potential  risk and
     represents  an  unacceptable level of public health protection
     for this  program in FY 80.

     Control Action

         One  additional regulation begun during FY 79  will be
     proposed.   Formal regulatory action will  be initiated on only
     four  chemical  hazards referred by  Testing  and Evaluation or
     other  programs.  This is the first level  at which any control
     actions  are initiated on existing  chemicals found to pose
     significant risks other than those already identified in FY 78
     and FY 79.   However, only two-thirds of the risks expected to
     be  identified  by Testing and Evaluation alone will have any
     control  action  at this level.

     Economic s

         Economic studies will be done  as required by  TSCA for
     additional  action on premanufacture notices,  reporting  and
     recordkeeping,  and control actions on  existing  chemicals to
     support Level  3 of these programs  (including  Level 4 of Testing
     and Evaluation).                                          (11 ( 7
  EPA Form 2410-11 (8-78)

-------
                   ENVIRONMENTAL PROTECTION AGENCY

FORM 2:  DECISION UNIT LEVEL ANALYSIS
  A. DECISION UNIT TITLE (AND CODE)

    CHEMICAL CONTROL  fT.?_im
                 HO OTS
                 REG.
MEDIA: Toxics
APPRO: A & C
  B. RESOURCE SUMMARY
FY 78 ACTUAL  FY 79 C. EST.   FY80INCR.
      FY 80 CUM.
LEVEL
-L-OF-2-
(continued)
POSITIONS PFT
OPFT
L_ FTE
BUDGET AUTH. (000.0)
















  C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
    OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.


   IMPACT

   Funding this  level would provide more complete but still
   inadequate  data  on which to  review and  screen premanufacture
   notices and would contribute to  the data  base for  use  in  future
   control actions.   The Agency could only partially  respond to
   existing  chemical hazards  recently identified for  control by
   Testing and Evaluation, and  take additional regulatory  control
   actions on  a  new  chemical  to prevent risks.

       Not funding  this level  would result  in less information on
   which to  base  a  review of  premanufacture  notices and  would
   prevent EPA from  taking any  action on any more than 0.25
   percent of  the  new chemicals manufactured in the United States
   during FY 80.   EPA would be  unable to respond to existing
   chemical  hazards  identified  during FY 80.
EPA Form 2410-11 (8-78)

-------
                           TAL  PROTFCTION AGENCY

FORM 
-------
                   ENVIRONMENTAL PROTECTION AGENCY

FORM 2:  DECISION UNIT LEVEL ANALYSIS
  A. DECISION UNIT TITLE (AND CODE)

    CHEMICAL CONTROL (L210)
                                 HO

                                 REG.
MEDIA. Toxics
APPRO: A & C
  B. RESOURCE SUMMARY
                FY 78 ACTUAL  FY 79 C. EST.  FY80INCR.
      FY80CUM.
    LEVEL
  -*-OF-2-
 (continued)
             POSITIONS
            PFT
           OPFT
            FTE
BUDGET AUTH. (000.0)
  C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
    OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.


 Economic s
     Economic  studies will be  done for a rule  on a new chemical
 and  two premanufacture notice  assessments  leading to actions
 under sections  5(e)  and 5(f).

 IMPACTS
     Funding  this  level would  provide the  resources for  the
 initial implementation of additional authorities unused  at
 lower levels  to  control new chemicals and  uses.   The order  to
 develop more  information would  supplement  the  data system
 searches and  letter requests.   The significant new use  and
 follow up reporting rules would allow EPA  to  defer acting on
 new chemicals  or  uses but retain the option  to control  through
 the premanufacture  notice process  at a later  date.  In  addition
 follow up control of a new chemical begun   in  FY  79 could be
 completed .

     Not funding  this level would mean that potential action on
 even less than 1% of premanufacture notices  would be prevented
 as  would completion of a regulation begun  in  the previous year.
 EPA would utilize less than the minimum degree of regulatory
 action necessary  to constitute  a positive  program of chemical
 control.
     0113
L
EPA Form 2410-11 (8-78)

-------
                           TAL  PROTECTION AGENCY
FORM i: DECISION UNIT LEVEL  ANALYSIS
Af DECISION UNIT TITLE  AND CODE         HO      MEU1M TOX SUB
L210 CHEMJCAL CONTROL                           APPRO | A & C
B, RESOURCE SUMMARY       FY  78  ACT  FY 79 C. E.  FY PO INCR   f- Y  80  CUM
        POSITIONS  PFT         ua.o        117.0        11.0        mo.o
 LEVEL            OPFT          i.o          b.o         i.o         10.0
05 OF 09           FTE                    113. 1        10. to        150, a
   BUDGET AUTH.  (000, 0)     1,548.0      7,967.0       599.1     6, 131, a
    C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
      OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.

     ACTIVITIES

     Premanufacture Review

         At  this level  additional  information will be sought on up
     to about  1/5  of new  chemical  notices  but complete assessmentts
     will be done  for  only  4%.   Informal  control action will be
     taken on  another  chemical.  An  additional significant new use
     rule and  one more  follow  up reporting rule will be written.
     Production  of one  additional  new chemical will be halted
     pending development  of  information and another which  poses an
     unreasonable  risk  will  be  controlled.  Two more new chemicals
     will be referred  for  expedited  formal rulemaking after
     expiration  of the  notice  period  but  no regulatory action will
     be possible.

     Control Action

         The only  additional  regulatory action which will be done at
     this level  is completion  of final  rules for two regulations on
     new chemical  referrals  begun  in  FY 79.

     Economics

         Economic  support  will  be  provided for premanufacture review
     actions and control  and  regulations  development at level 5.

     IMPACTS

       Funding this level  will  provide  more complete information to
     assess  new  chemicals  and  allow  regulatory actions begun in FY
     79 to be  completed.   A  few additional control actions will be
     possible  on new chemicals.

       Not funding this level will significantly decrease the amount
     of information available  to review new chemicals and limit
     direct  regulatory  actions  taken  to only a token number.
     Regulations begun  in  FY  79 on new  and existing chemicals could
     not be  completed.
                                                              0111
   EPA Form 2410-11 (8-78)

-------
                ENVIRONMENTAL  PROTECTION!
     2? DECISION  UNIT  LEVEL  ANALYSIS
A, DECISION UNIT  TITLE  AND  CODE         HQ      MEDIA; TOX  SUB
L210 CHEMICAL CONTROL                           APPROj A &  C

B, RESOURCE SUMMARY       FY 78  ACT  FY 79 C. E.  FY Ł0 INCH  *FY  8o"cU*
        POSITIONS  PFT        ag.o        IJT.O        2^,0        lea.o
 LEVEL            OPFT          i.o          b,o         2.0         12.0
06 OF 09           FTE                    113. 1        22.8        173.2
   BUDGET AUTH. (000. C)     1,5«8.0      7,987.0     1#«16.«     10,048.2
    C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
      OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.

     ACTIVITIES

     Premanufacture Review

         At  this level, Premanufacture Review has sufficient
     resources  to choose  and  use  all possible authorities available
     to directly deal with  new  chemicals.   Two actions will be taken
     to control manufacture,  processing,  distribution, use, and
     disposal of new chemicals  posing unreasonable risks, and one
     designation will be  made  to  the list  of  chemicals which pose or
     may pose unreasonable  risks  and for  which additional
     information is required  in premanufacture notices.  In
     addition,  over 20% of  notice reviews  will be supplemented with
     information from data  system searches and letter requests for
     health  and safety  studies.   About 7%  of  premanufacture notices
     will be subject to complete  assessment.   Another chemical will
     be subject to informal  control. Additional section 5(e)
     orders, significant  new  use  rules, and follow up reporting
     rules will be done.

     Control Action

         Two more new chemicals will be  referred for formal
     rulemaking after the notice  period and regulations will be
     initiated  on two-thirds  of these and  the other new chemical
     referrals  from prior levels.   A regulatory action will be
     initiated  and proposed  on  an additional  existing, chemical
     hazard  referred in FY  80.

     Economics

         Economic studies will  be done as  required for additional
     premanufacture notice  actions,  regulations, and recordkeeping
     and reporting rules  in  Level 6  of these  programs.

     IMPACT

         Funding this level  will  allow use of the entire range of
     authorities for control  of new  chemicals.  In addition, action
     would be possible  on some  of the new chemicals which have been
         0112
  EPA Form 2410-11 (8-78)

-------
                    ENVIRONMENTAL PROTECTION AGENCY
FORM 2:  DECISION UNIT LEVEL ANALYSIS
  A. DECISION UNIT TITLE (AND CODE)

    CHEMICAL CONTROL (L210)
                  HQ
                     OTS
                  REG.
MEDIA: Toxics
APPRO: A & C
  B. RESOURCE SUMMARY
FY 78 ACTUAL  FY 79 C. EST.  FY 80 INCR.
      FY 80 CUM.
LEVEL
-i-oF-2.
(continued)
POSITIONS PFT
OPFT
FTE
BUDGET AUTH. (000.0)
















  C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
    OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.


   referred for formal regulations.  At  this level  the levels  of
   premanufacture  control first  begin  to  approach  the level
   necessary to fulfill EPA's  commitment  to protect  health  and the
   environment  from chemical  risks before the chemicals are
   released to  the  environment.

        Not funding  this level  would prevent implementation  of  the
   remaining unused authorities  for new  chemical  control and
   further delay action on  another existing chemical and expedited
   rulemaking on new chemicals.
                                                               0113
EPA Form 2410-11 (8-78)

-------
                           TAL  PROTECTION
FORM 2: DECISION  UNIT  LEVEL  ANALYSIS
A, DECISION UNIT TITLE  AND  CODE         HG      MEDIAj TOX SUB
L?IO CHEMJCAL CONTROL                           APPRC: A & c

B, RESOURCE SUMMARY       FY 78  ACT  FY 79 C. E.  FY 80 INCH   FY  80  CUM
        POSITIONS  PFT        42.0        117.0        n.O        175.0
 LEVEL            OPFT          l.o          fe.O         i.O         13.0
07 OF 09           FTE                    113. 1        10,6        183.6
   BUDGET AUTH. (000.0)     1,5«8.0      7,987.0       415.0     10,
-------


















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                     ENVIRONMENTAL PROTECTION AGENCY

FORM 1:  DECISION UNIT OVERVIEW
  A) DECISION UNIT TITLE (AND CODE)                    HQ  QTS     MEDIA: Toxics
     Information Integration  (L215)                REQ.        APPRO: A.&C
  B)  LONG RANGE GOALS & MAJOR OBJECTIVES
    Integration/Information objectives are to:   (1)  Obtain information
    from industry using rules  promulgated under authority of Section 8 of
    the Toxic Substances Control Act for the use of  OTS and others for
    the purposes of assessing  and regulating chemical hazards;  (2)  Establish
    and use information storage and retrieval systems to serve  the information
    needs of the Toxic Substances program^while maintaining adequate control
    of chemical information and data to  assure the security of  confidential
    business information;  (3)   Provide monitoring data and literature
    searching services to  other OTS offices on an as-needed basis; (4)
    Perform monitoring studies to predict chemical problems and to establish
    and empirical basis for risk assessment; (5)  Provide mechanisms and
    analytic support to assist OTS Management in coordinating and integrating
  C)  FY 78 ACCOMPLISHMENTS
    Prepared Annual Report to  Congress (Section 30).   Established guidelines
    for contracts with States  (Section 28).  Initiated support  to the Toxic
    Substances Priorities  Committee.  Established pilot public  participation
    program in Region II.   Established basic data security procedures and
    facilities, and began  to make confidential data  available under secure
    conditions.  Promulgated submission  of  health and safety studies rule,
    substantial risk notification policy,  and interim guidelines on exports.
    Provided information to and assisted industry in complying  with require-
    ments to report chemicals  for inclusion in the Chemical Inventory and
    other regulations.   Collected and analyzed  chemical data in preparation for
    inventory publication  in early FY 1979.  Conducted literature searches
    and monitoring studies as  needed to  support testing, control and risk
    assessment activities.
  D)  F Y 79 PROGRAM DESCRIPTION
    The Office of Program  Integration and Information (OPII) will promulgate
    five TSCA Section 8 reporting and recordkeeping  regulations, which will
    serve OTS and other users'  needs for information.  Several  regulations
   will be in the form of model rules which will be used repeatedly (36
    iterations) to provide users with information on specific chemicals of
    concern for regulation,  premanufacturing review,  and various risk, exposure
    and economic  assessments.

    Development and operation  of basic facilities and services  to provide
    chemical information to OTS programs and other users will continue.  A
    significant increase in the number of literature searches performed (171
    total)  is expected in  order to support  increased activity on testing rules,
    risk assessments and initiation of the  premanufacturing review program.
    The Chemical  Inventory will be published in early FY 1979.

    Contracts will be made with 3-5 states  to prevent or eliminate unreasonable
    risks associated with  chemical substances or mixtures which EPA is unable
    or unlikely to prevent or  eliminate.   Four  regional programs to encourage
    public  participation in, and input to OTS activities will be funded.
    Cooperative efforts with other agencies will continue through the IRLG,
    CEQ and other inter-agency programs  to  provide for exchange of information,
EPA Form 2410-10 (8-78)                                                            0123

-------
                     ENVIRONMENTAL PROTECTION AGENCY

FORM 1:  DECISION UNIT OVERVIEW
  A) DECISION UNIT TITLE (AND CODE)                    HO.  OTS      MEDIA:  Toxics

      Information Integration  (L215)                REG.         APPRO:  A.&C.
  B)  LONG RANGE GOALS & MAJOR OBJECTIVES

  policies and activities with those of other EPA regulatory programs, EPA
  regions, state and local government, public interest groups, other Federal
  agencies and other countries; (6)  Provide information to assist industry
  in complying with TSCA provisions and provide OTS management with feed-
  back from industry regarding TSCA implementation.
  C)  FY 78 ACCOMPLISHMENTS
  D)  FY 79 PROGRAM DESCRIPTION
  policies, methods of operation, etc. for incorporation into EPA and these
  agencies toxic substances activities.  Procedures for Section 9 referrals
  of chemicals for regulation under other authorities will be developed.
  Staff support to the Toxic Substances Priorities Committee will be
  provided to facilitate the coordination and integration of EPA activities
  on toxic substances and modify the chemical priority-setting system.

  Monitoring efforts (eighteen) will be conducted to support the requirements
  of Testing and Evaluation and Chemical Control during FY 1979.  Monitoring
  data will be provided as required for chemicals for which early warning,
  intermediate or final assessment reports are being prepared and for
  chemicals for which Section 6 control regulations are being developed.
  In addition, OTS will assess long-term monitoring needs and prepare an
  OTS monitoring program plan during FY 1979.

  Contact with industry will be provided by conducting colloquia, training
  seminars, and attending industry meetings.  Industry will be assisted in
  complying with major regulations by maintaining a nation-wide toll-free
  telephone service, and distributing literature, copies of regulations
  requiring industry action, and requisite forms.
EPA Form 2410.10(8-78)

-------
                                AL PRPTFCTION AGENCY

FORM  H:  DECISION UNIT  LEVEL ANALYSIS
  ,  DECISION UNIT TITLE AND  CODE          HQ        MfcUIM  TOX  SUB
1,215 INFORMATION INTEGRATIONCINC  Eis  PREP)       APPROI  A &  c
•IWflVVtfllMVMi * •> • * •• * * • ^ <• W ^ ** ** " * ^ * ^* • • • Ml W * • W • • V <• • V • 49 • W W • • • W ^ W W w ™   • • W M     W
B.  RESOURCE SUMMARY       FY 78 ACT FY 79 C. E.   FY 60  JNCR    FY  80 CUM
         POSITIONS  PFT         72.0         9«.0          69.0          69.0
  LEVEL              OPFT           r
   EPA Form 2410-11 (8-78)

-------
                      ENVIRONMENTAL PROTECTION AGENCY
FORM 2: DECISION UNIT LEVEL ANALYSIS
  A.  DECISION UNIT TITLE (AND CODE)

   Information Integration (L215)
                   HQOTS

                   REG.
MEDIA: Toxics

APPRO:A&C
  B.  RESOURCE SUMMARY
FY 78 ACTUAL  FY 79 C. EST.   FY80INCR.
      FY 80 CUM.
LEVEL
1 8
POSITIONS PFT
OPFT
FTE
BUDGET AUTH. (000.0)
















  C.  DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
     OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.

   special need for data on quick response basis, but no additional system
   improvements would be made.   Services which would be provided at this level
   include preparing and publishing the revised chemical inventory, indexing;
   of health and safety studies, obtaining data on chemicals based on their
   chemical structures (substructure searching) at a constrained level to
   support risk assessment activities, and preparation of Freedom of Infor-
   mation Act (FOIA) responses  and Federal Register notices for OTS.  Access
   to non-EPA computer systems  (multiple access) would be provided at this
   level, and some integration  of TSCA data with data from other sources
   would  be possible.  Minimal  support would be provided at this level
   for network development activities to provide the necessary linkages of
   the OTS computer system to the Chemical Substances Information Network
   (EPA-wide computer systems).  Sixty-eight literature searches of various
   types  would be performed at  this level to support the Level 1 needs of
   Testing and Evaluation.  At  this level, it is likely that significant
   delays in all information services would occur frequently.

   Program Integration

   OPII is responsible for promoting EPA headquarters program, regional,
   state, local, interagency and international integration, coordination
   and liaison.   At this level  most available resources would be used to
   maintain limited contact with EPA regional programs, State programs and
   other  Federal agencies.  In  order to provide this limited support of
   on-going activities, the only internal (to EPA headquarters) functions to
   be maintained would be to utilize the comprehensive chemical priority-
   setting system developed in  FY 1979 to support the Toxic Substances
   Priorities Committee (TSPC)  and to prepare the Annual Report to Congress
   required by TSCA.  No analytical needs would be answered at this level,
   and virtually no intra-agency integration would be conducted or partici-
   pated  in by OTS.   Funding would be provided for contracts with three to
   five states to prevent or eliminate unreasonable risks which EPA is unable
   to address.  The four regional public participation programs begun in
   FY 1978 and FY 1979 would be continued.  These programs establish and
   maintain advisory groups which provide public input to the Agency regarding
   toxic  substances.  The goal  is to have such programs in place in all regions
   by the end of FY 1980.  Cooperative efforts with other Federal agencies
   would  continue at a constrained level through the IRLG and CEQ.  These
   cooperative programs would establish coordinated Federal policies for
   conducting risk assessments, guidelines for chemical testing, methods for,
   chemical information exchange between agencies, common chemical identifi-
   cation codes and consolidated interagency work plans for  twenty-four
   012S
EPA Form 2410-11 (8-78)

-------
                     ENVIRONMENTAL PROTECTION AGENCY
FORM 2:  DECISION UNIT LEVEL ANALYSIS
  A.  DECISION UNIT TITLE (AND CODE)

   Information Integration (L215)
                   HQ OTS
                   REG.
MEDIA:Toxics

APPRO:A&C
  B.  RESOURCE SUMMARY
FY 78 ACTUAL  FY 79 C. EST.   FY80INCR.
      FY80CUM.
I LEVEL8
o r "••

POSITIONS PFT
OPFT
FTE
BUDGET AUTH. (000.0)
















  C.  DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
     OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.

   chemicals for which regulations are being considered.

   Monitoring

   OPII has the  responsibility within OTS for  providing all monitoring
   information required to support TSCA regulatory and information needs.
   This can be accomplished through cooperative studies with other EPA
   programs, other Federal agencies, utilization of regional capabilities
   and contract  support.   At this level, the only activity conducted would
   be monitoring five chemicals to support Level 1 early warning,  intermediate
   and final risk assessments.  At this level, the monitoring plan developed
   in FY 1979 would not be implemented.   This  plan, if implemented, would
   provide OTS with the capability to predict  problems with chemical substances
   before they manifest themselves by substantial damage to human health
   or the environment.   Instead, at this level, OTS would be limited to
   attempting to predict  problems by maintaining familiarity with the current
   literature and reviewing results of monitoring projects conducted by
   other programs.

   Industry Assistance

   OPII is responsible for maintaining close liaison with industry by direct
   contact through colloquia,  seminars,  site visits and attendance at
   industry meetings.  It is also responsible  for providing assistance to
   enable industry to comply with TSCA regulations.  At this level the
   program would be limited to providing assistance by telephone,  mailings
   and in writing; virtually no personal contact would be possible.  Assistance
   would be provided on a limited number of existing and new TSCA regulations
   and would include maintaining the toll-free nationwide telephone line
   at a curtailed level of service, resulting  in unanswered calls.  Backlogs
   of unanswered written  inquiries would be likely.

   Analysis:

   Funding this  level would allow continuation of most of the legally
   mandated activities  OPII is assigned,  (such as maintaining data security,
   preparing the Annual Report, promulgating recordkeeping and reporting
   rules, and maintaining an office to assist  industry) though generally
   at an unacceptable level (e.g. allowing significant delays and backlogs).
   Providing support services such as FOIA responses, monitoring and liter-
   ature searching at a level responsive to Level 1 Testing and Evaluation
   and Chemical  Control requirements would require severe  cutbacks in  Q1 27
EPA Form 2410-11 (8-78)

-------
                     ENVIRONMENTAL PROTECTION AGENCY
FORM 2:  DECISION UNIT LEVEL ANALYSIS
  A.  DECISION UNIT TITLE (AND CODE)
 Information  Integration  (L215)
                   HQ c
                   REG.
MEDIA:  Toxics

APPRO:  A.&C.
  B.  RESOURCE SUMMARY
FY 78 ACTUAL  FY 79 C. EST.   FY 80 INCR.
      FY 80 CUM.
LEVEL
1 8
t POSITIONS PFT
OPFT
FTE
BUDGET AUTH. (000.0)
















  C.  DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY.  DESCRIBE THE BENEFITS
     OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.

 program development activities begun in FY 1978 and 1979 in Integration,
 Monitoring and Information Systems.

 Not funding this level would result  in stopping virtually all TSCA
 implementation, since both Chemical  Control and Testing and Evaluation
 rely on the support activities and the basic facilities and capabilities
 OPII provides.  In addition, information prepared and submitted to EPA
 under TSCA would not be preserved if this level were not funded, and pro-
 tection of confidential business data could not be provided.
      0128
EPA Form 2410-11 (8-78)

-------
                                AL PROTECTION

FORM  a? DECISION  UNIT  LEVEL  ANALYSIS
A.  DECISION UNIT  TITLt  AND  CODE          HQ       MEl»IA| TOX  SUB
L?i5  INFORMATION  INTEGRATIONCINC  EIS PREP)      APPRCI A  &  c

B.  RESOURCE SUMMARY       FY  76 ACT FY  79 C. E.   FY  PO*INCR"*"""eo"cu"
         POSITIONS  PFT          72.0         94.0          U.O         60.0
 LEVEL              OPFT           fl.o         ia.0           1.0         10.0
°2  °F  '>*             FTE                       107.a           7.0        101.3
    BUDGET  AUTH.  (000.0)      5,911.0     t«,676.2       1,693.7    11,190.a

    C.  DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
       OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.
     Activities:

     Chemical Information

     At this level,  OPII  would be able to support user needs  by increasing
     the frequency  of  the use of each model rule from  two or  three  times
     per year to  about six times per year.  This would still  result in an
     unacceptable time-lag for the purposes of premanufacturing review and
     would allow  utilization of only four of the five  or  six  available model
     rules  in this  manner.

     Fifty additional  literature searches supporting Testing  and Evaluation
     Level 2 assessments  and testing rules would be provided.  No additional
     data retrieval  support, literature searching or other  information
     program activities could be provided at this level.   If  funded at Level 2
     premanufacturing  review would experience significant delays, due to
     insufficient data support provided by this level.

     Program Integration

     Additional resources would be placed in inter-agency programs, regional
     liaison and  international coordination but all integration activities
     would continue  to be curtailed in comparison to the  FY 1979 level.
     Level 2 resources would enable OTS to respond to  a very  limited number
     of top-priority in-house inquiries for summary information on  chemicals,
     using the management system for active chemicals  (i.e.,  chemicals for
     which regulations are being developed or research is being conducted).
     This level of  funding would continue to leave OTS with little  input inte-
     gration of EPA  program activities related to toxic substances.

     Monitoring

     At this level,  five  additional chemicals would be monitored to support
     Testing and  Evaluation.  OPII would also be able  to  initiate one or two
     additional monitoring projects on chemicals identified for which infor-
     mation is needed.  These projects would not contribute to implementing
     the OTS monitoring plan but would provide information  on a high-priority,
     quick turnaround  basis as needed to OTS management.

     Industry Assistance

     Industry liaison  activities would be upgraded to  include some additional
     personal contact  with industry through site visits,  colloquia and meetings.
  EPA Form 2410-11 (8-78)

-------
                     ENVIRONMENTAL PROTECTION AGENCY

FORM 2:  DECISION UNIT LEVEL ANALYSIS
  A.  DECISION UNIT TITLE (AND CODE)

    Information Integration  (L215)
                   HO OTS

                   REG.
MEDIA.

APPRO:
       Toxics
                                                                      A.&C.
  B.  RESOURCE SUMMARY
FY 78 ACTUAL  FY 79 C. EST.   FY 80 INCR.
      FY80CUM.
LEVEL
2 8
	 OF 	

POSITIONS PFT
OPFT
FTE
BUDGET AUTH. (000.0)
















  C.  DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY.  DESCRIBE THE BENEFITS
     OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.
   Services provided for industry assistance (e.g.  the nationwide toll-free
   telephone service,  material preparation and  written responses) could be
   slightly upgraded and some  reduction of backlogs would be possible.


   Analysis:

   Funding this  level would provide upgrading  of several major service
   and analytical  capabilities, but would  not  eliminate  most backlogs
   of unfulfilled  actions.   At this level  OTS would be unable to provide
   substantial input to     iiPA program integration and policy development
   regarding chemical substances.  Facilities  such as the dedicated computer
   could  not be  used to  full design capacity.

   Not funding this level would substantially  slow down  risk assessments and
   premanufacturing review activities because  of the inadequate level of
   service OPII  would provide.  OTS/EPA ability to coordinate activities
   with other agencies and governmental entities would be significantly
   impaired.
        0130
EPA Form 2410-11 (8-78)

-------
                                 AL  PROTECTION  AGENCY
 FORM  2: DECISION  UNIT  LEVEL  ANALYSIS
 A. DECISION UNIT  TITLE  AND  CODE          HO       MEDIA}  TOX  SUB
 L215  INFORMATION  INTEGRATIONCINC  EIS PREP)      APPROI  A &  c
 8, RESOURCE  SUMMARY       FY  76 ACT  FY 79  C. t.   FY  60 INCR    FY  80 CUM
          POSITIONS   PFT          7?.0          9«,0          1«.0          94.0
  LEVEL              OPFT           4.0          12.0           1,0          11.0
 03 OF  08             FTE                       107.4           e.«         109.7
    BUDGET  AUTH.  (000,0)     5,911,0     14,876,2       3,062,5      14,272.9
  C.  DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
     OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.

   Activities:

   Chemical Information

   At this  level an additional information rule  would be promulgated serving
   the special  information needs of one or more  OTS programs.  In addition,
   twenty-four  more iterations of model rules  would be provided, allowing
   monthly  use  of  four rules, or less frequent use of more model rules
   which would  reduce delays in obtaining information by this method for
   premanufacturing review and others.

   Development  of  information systems at this  level would provide refinements
   to the exposure index to include methods to prioritize chemical data for
   scientific review.  User facilities including the reference room would
   be improved  and the number of remote terminals would be increased to
   improve  access  to computer services.  Microfische retrieval services
   would be automated at this level.   Substructure searching services would
   be significantly expanded.  These system and  service refinements would
   allow more adequate responses to OTS program  needs.  Approximately
   sixty additional literature searches would  be performed to support
   Testing  and  Evaluation Level 3 and 4 needs.

   Monitoring

   At this  level four additional chemicals would be monitored to support
   Testing  and  Evaluation Level 3 risk assessment activities.  Support
   to Chemical  Control would begin at this level by providing monitoring
   for two  chemicals for which control regulations (Section 6) are to be
   developed.

   Industry Assistance

   At this  level direct contact with industry  to maintain ready access and
   good  lines of communication would be accomplished as needed.  Program
   literature such as schedules and brochures  would be improved, mailing
   lists expanded  and the backlog of written responses eliminated.  Assist-
   ance  for several additional regulations would be provided at this level.

   Analysis:

   Funding  this level would allow OPII to provide an improved level of
   support  in industry assistance and monitoring, but would do little by
EPA Form 2410-11 (8-78)

-------
                     ENVIRONMENTAL PROTECTION AGENCY

FORM 2:  DECISION UNIT LEVEL ANALYSIS
  A.  DECISION UNIT TITLE (AND CODE)

     Information Integration  (L215)
                   HQ   OTS

                   REG.
MEDIA:   Toxics

APPRO:   A.&C.
  B.  RESOURCE SUMMARY
FY 78 ACTUAL  FY 79 C. EST.   FY80INCR.
      FY 80 CUM.
3 LEVEL8
	 OF 	
POSITIONS PFT
OPFT
FTE
BUDGET AUTH. (000.0)
















  C.  DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY.  DESCRIBE THE BENEFITS
     OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.
   way of  developing  OPII's  basic  capabilities  to  provide  services  in
   these areas.   Information systems  and  services  could  be improved,  but
   would not be  adequate  at  this level  to provide  needed services on  a
   timely  basis.   No  improvements  in  Program Integration would be possible.

   Not funding this level would allow a build-up of  unfulfilled support
   requirements,  and  would appreciably slow programs in  risk assessment,
   premanufacturing review and chemical control.
       03.32
EPA Form 2410-11 (8-78)

-------
                   ENVIRONMENTAL PROTECTION AGENCY

FORM  2: DECISION UNIT  LEVEL  ANALYSIS
A,  DECISION UNIT  TITLE  AND  COUfc          HQ       MEDIAt TOX SUB
L215  INFORMATION  INTEGRA T I DM ( JNC  EIS PREP)      APPRPj A  & C

B.  RESOURCE SUMMARY       FY 78 ACT FY  79 C.  E.   FY  80 JNCR   FY 80  CUM
         POSITIONS  PFT          72,0         94.0           9,0        103,0
 LEVEL              OPFT           4.0         12.0                         11.0
04  OF 06             FTE                       107. a           9.0        116,7
    BUDGET  AUTH.  (000.0)      5,911.0     14,876.2       1,273.6     15,546.5
     C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
       OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.
     Activities:

     Chemical Information

     At this level additional information search and retrieval services  would
     be provided to premanufacturing  review to catch up with increasing
     requirements.   No additional  system improvements or iterative use of
     model rules would be provided at this level.

     Program Integration

     At this level, emphasis would be placed on upgrading intergovernmental
     integration to the FY 1979  level.  International State and regional
     coordination activities would increase only to their FY 1979 level.  No
     improvements in analytic capabilities or headquarters program integration
     could be made at  this level.   New public participation programs  would
     begin in three additional regions.

     Monitoring

     At this level, OPII would initiate a small program to contribute to the
     funding of ongoing EPA monitoring projects to generate toxic substance
     data required by  OTS.  At this level, this piggy-backing strategy would
     fund six to eight projects.   It  would begin to implement the OTS basic
     monitoring program plan to  meet  OTS needs for predictive information.

     Analysis:

     Funding this level would allow OPII to conduct coordination and  integration
     activities at a level roughly equal to FY 1979, with the exception  of
     headquarters program integration which still could not be funded.   In
     addition a predictive monitoring program which would enable OTS  to  antici-
     pate chemical problems could  begin at this level.

     Not funding this  level would  demonstrate a low level of committment to
     developing regional public  participation programs.  Not funding  this
     level would also  provide a  curtailed level of inter-governmental integra-
     tion in comparison to FY 1979, resulting in duplication of Federal  efforts
     in assessing the  risks and  regulating specific chemicals.  Not implementing
     the monitoring plan would result in OTS failing to predict chemical problems
     before substantial damage is  done to human health or the environment.
   EPA Form 2410.?] (8-78)

-------
                   ENVIRONMENTAL  PROTECTION  AGENCY

FORM  <>;  DECISION UNIT LEVEL ANALYSIS
***"*w — **"i"i****t*****'»w"*w*w»»w«»»wi*w»»«p»»t«i»«p»ww«»«»m*i*»»»»^»1p«B»B(>fi
A,  DECISION UNIT TITLE  AND CODE          HD       MEl'IM  TOX SUB
L215  INFORMATION INTEGRATION (INC EIS PREP)      APPROj  A  it C
B, RESOURCE SUMMARY
POSITIONS PFT
LEVEL OPFT
05 OP 06 FTE
BUDGET AUTH. (onn.o)
FY 78 ACT FY
72.0
fl.o

5r
-------
                               TAL  PROTECTION  AGENCY

FOPU 2S  DECISION' UNIT LEVEL  ANALYSIS
~ * ™  • ™ W   W • W W • W OT W V M V* • •• V *t V • W • OT * V W M •§ • W W 

216.6 FY 80 CUM 127.0 l«.o i«i.5 19,029.1 C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING. Activities: Chemical Information At this level one additional recordkeeping and reporting rule would be promulgated, and twelve additional iterations of model rules would be done, providing an acceptable level of support for OTS. In addition an effort would be launched to coordinate and integrate Federal toxic substances information activities. This would include revising the Substantial Risk Notification Policy Statement to eliminate the necessity of duplicative submissions to several agencies under several provisions. Consolidation of recordkeeping and reporting rules would also begin at this level. Thirty-four additional literature searches would be conducted in support of Testing and Evaluation Level 7 activities. Program Integration At this level, OTS could begin to provide summary information on active toxics within EPA as requested, and a small amount of analytic support could be provided. Additional staff support for inter-agency coordination would also be provided at this level to further support incorporation of other agencies' inputs into EPA toxic substances assessment and regulatory activities as well as OTS input into similar toxics activities of those agencies. Monitoring At Level 6, four additional chemicals would be monitored to support Level 7 risk assessments, and additional chemical monitoring would be conducted to support regulation development. At this level, OTS could initiate monitoring projects which would support development of a basic monitoring program tailored to OTS needs and would actively participation in other monitoring programs. Industry Assistance Assistance to industry would be provided for additional major regulations in order to keep pace with increasing OTS regulatory actions. Analysis: Funding this level would allow OPII to establish a substantial basic 0135 EPA Form 2410-11 (8-78)


-------
                     ENVIRONMENTAL PROTECTION AGENCY

FORM 2:  DECISION UNIT LEVEL ANALYSIS
  A.  DECISION UNIT TITLE (AND CODE)

   Information  Integration (L215)
                   HQ  OTS
                   REG.
MEDIA:  Toxics

APPRO:  A.&C.
  B. RESOURCE SUMMARY
FY 78 ACTUAL  FY 79 C. EST.   FY80INCR.
      FY 80 CUM.
6 LEVEL8
POSITIONS PFT1
OPFT
FTE
BUDGET AUTH. (000.0)
















  C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
    OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.

   monitoring program and increase all service functions to keep pace with
   Testing and Evaluation and Chemical Control needs.

   Not funding this level would allow support activities to lag behind
   demand and would prevent the development of a basic monitoring program
   which could assist OTS in identifying and predicting future chemical
   problems, and would provide required information regarding sources,
   uses and flows of chemical substances in the environment.
      012S
EPA Form 2410-11 (8-78)

-------


















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-------
                     ENVIRONMENTAL PROTECTION AGENCY

FORM 1:  DECISION UNIT OVERVIEW
 A)  DECISION UNIT TITLE (AND CODE)                    HQ          MEDIA:  Toxics

 Toxics  Management (L220)                          REG. X       APPRO:  A  Ł•  C
  B)  LONG RANGE GOALS & MAJOR OBJECTIVES
 The  long  range goals of the regional  toxics  management  program are  to  imple-
 ment the  provisions of the Toxic Substances  Control Act at  the State and  local
 Level and to integrate the Agency's regional implementation of toxics  activi-
 ties in all media.   The major objectives  to  be accomplished are:
   More efficient and  effective conduct of regional toxics  activities  through
   development and implementation of  an integrated toxic substances control
   program within each region through media  program coordination.
   Incorporation of State and local expertise into the  national toxic  sub-
   stances program through establishment  of  cooperative programs with  State
   and local programs  on toxic substances program activities.
   Insuring the provision of  adequate, timely and responsive assistance to
   industry within the region through management of a toxic substances
   industry assistance program.        ....Continued
  C)  FY 78 ACCOMPLISHMENTS
 In FY78,  the regions have begun formulating  and establishing the regional role
 in the toxic substances program.   They have  also begun  staffing and organizing
 to implement the regional toxic substances program and  some have completed
 these actions.   The majority  of program activity in almost  every region has
 been provision of the  required response to the initial  influx  of requests for
 assistance from industry on the inventory reporting,PCS,  chlorofluorocarbon
 and  other regulations.   Essentially all regions have begun  strong efforts to
 establish integrated toxic substances programs within the region.   In  a few
 instances regions have completed the  first stages of development and are
 Beginning implementation and  operation.   Most regions have  also begun  coopera-
 tive efforts with their States and localities on toxic  substances program
 activities.   The five  regions (II,III,IV,V and VI) with the greatest amount of
 toxic substances related activity within  the region have put some limited
 effort into the remaining toxic substances objectives (public  information,
  D)  FY 79 PROGRAM DESCRIPTION
 In FY79 most of the foundation building (organization,  staffing,etc.)  for
 regional  program implementation begun in  FY78 will be completed. Efforts
 toward all of the regional objectives will increase over FY78  and the  relative
 .evels of effort among the objectives will remain much  the  same with one
 exception:  the demand  for industry assistance is expected to decline somewhat
 is industry becomes more familiar with the program and  the  initial regulations
 lave been in place  for awhile such that this activity will  no  longer take the
 aajority  of regional efforts.   Instead, the  integration function will  receive
 the  most  substantial effort in the regions.   Most regions will be actively
 ieveloping their integration  programs and moving to implement  them, while those
 ew  which have already completed development will be operating and refining
 :heir programs.   Almost all regions will  increase their efforts to cooperate
 ith the  States  and localities primarily  through exchange of information.  A
 greater number of regions will be able to provide their input  to increasing
 trategy  and regulations development  activities.  As the National toxic sub-
 stances program becomes operational,  the  regions will provide  more support
 :hrough increased coordination and conduct of monitoring, particularly in those
 •egions with a high level of  toxic substances activity.   The regions will also
 •xpand their efforts to identify and  assess  regional toxic  substances  problems.
 lost regions will put  a small amount  of effort  into coordinating with  other
 ederal Agencies and conducting public information programs.
 EPA Form 2410-10 (8-78)

-------
                     ENVIRONMENTAL PROTECTION AGENCY

FORM 1:  DECISION UNIT OVERVIEW
A ) DECISION UNIT TITLE (AND CODE)
Toxics Management (L220)
HO.
REG. X
MEDIA: Toxics
APPRO: A & C
  B)  LONG RANGE GOALS & MAJOR OBJECTIVES
 o   Insuring that the public is made aware of and is provided input to toxic
     substances program activities through conduct of public information
     programs.
 o   Incorporation of regional perspectives into the national toxics program
     through participation in toxic substances strategy and regulations
     development.
 o   More efficient and effective Federal implementation and conduct of toxic
     substances activities through cooperation with other Federal agencies at
     the regional level on toxic substances program activities.
 o   Action on local problems and/or inclusion of them into the national progran
     through identification, priority setting, and assessment of regional toxic
     substances problems.
 o   Incorporation of field data into action on toxic substances through coor-
  0  FY78 A0(?COMPLrs0HnMENTS0  monitorin§ within the regions in support of the
                                                  toxic substances program.

 strategy and regulations development, Federal agency cooperation, regional
 problems and monitoring) as well.
  D)  FY 79 PROGRAM DESCRIPTION
EPA Form 2410-10 (8-78)

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                   ENVIRONMENTAL  PROTECTION AGENCY

FORM  2: DECISION UNIT LEVEL  ANALYSIS
A,  DECISION UNIT TITLE AND  CODE          PG        MEPIAJ  TUX  SUB
L2?u  TOXICS MANAGEMENT                              APPRO?  ARC
     *      "* ** ~ ™ *" * *  ** * ^ ••••^^•fcxww ••^•'^'••'^•••••P •• ••••••••^•i^ •• ^ m fp • (i ^ • •• • w IP w • •* v •
B,  RESOURCE SUMMARY        FY 78  ACT FY  79 C.  E.   FY BO  INCR    FY 80 CUM
         POSITIONS  PFT         32.0          «3.o          30.0          30.0
 LEVEL              OPPT           5.0           6.0           7.0           7.0
01  OF 07             FTE                        U9.7          ilfc.5          46.5
    BUDGET  AUTH.  (000. C)       ^7^,0      1,193,0        884,1         884.1
     C DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY.  DESCRIBE THE BENEFITS
       OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.
    Activities
    At this level the regional toxics management program will consist of the
    following activities (overall  priority  among them will remain as in FY 1979):
    Integration programs begun in  previous  years will be maintained only at the
    levels of effort required to ensure  their continued operation in essentially
    all regions.  This function will remain as  the highest priority program for
    regional efforts but the scope of activity  will generally be limited and few
    improvements or refinements to operation will be able to be made.

    Essentially all regions will continue their efforts to ensure that assistance
    to industry is provided.  At this level referral of requests to headquarters/
    contractors will be relied upon to a large  extent.  The demand for regional
    assistance overall is expected to remain at a level somewhat lower than the
    first year of program implementation.   Most, but not all, regions will main-
    tain their efforts to cooperate with States and localities.  The level of
    cooperation will be somewhat lower even in  those regions which do continue
    their efforts.

    Only about half of the regions will  be  able to conduct any problem identifica-
    tion and assessment or monitoring activities in support of the toxic substance
    program.  In the limited number of regions  which maintain these programs, the
    levels of effort will generally remain  at levels similar to the previous year.

    Most regions will continue their public information programs but at more
    limited levels which will primarily  respond to public inquiries and requests.

    Only about half of the regions will  be  able to continue their participation
    in strategy and regulations development and cooperation with other Federal
    agencies.

    Impact
    Funding this level of resources  provides  a base toxic substances program in
    each of the ten regions.   These  programs  will primarily be response oriented.
    Limited benefits to the national toxics program would be provided by some
    increased efficiency and  effectiveness through integration of toxics implemen-
    tation; expansion of the  information  base, capabilities and means of action,
    and expertise through cooperation with States and localities; and broadening
    of the base for action through regional problem identification and monitoring
    support.
    Not funding this level would mean that no implementation of the toxics program
    at the State and local level could  take place, depriving the National program
    of valuable means necessary to effective  carrying out of the intents of TSCA
    to obtain information and take action when necessary to prevent risks.
       -                    	———	ul'i
   EPA Form 2410-11 (8-78)

-------
                     ENVIRONMENTAL PROTECTION AGENCY
FORM 2:  DECISION UNIT LEVEL ANALYSIS
  A. DECISION UNIT TITLE (AND CODE)
  Toxics  Management  (L220)
                   HQ

                   REG. X
MEDIA: Toxics

APPRO:A & C
  B. RESOURCE SUMMARY
FY 78 ACTUAL  FY 79 C. EST.   FY 80 INCR.
      FY80CUM.
LEVEL
1 OF ?

POSITIONS PFT
OPFT
FTE
BUDGET AUTH. (000.0)
















  C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
    OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.

  Headquarters would have to take on  these activities but would be less
  efficient and effective in maintaining  the  necessary continuous contact with
  the  wide-ranging concerns.
EPA Form 2410-11 (8-78)

-------
                   ENVIRONMENTAL  PROTECTION

FORM  as  DECISION UNIT LEVEL  ANALYSIS
A,  DECISION UNIT TITLE  AND CODE
L2?0  TOXICS MANAGEMENT
APPROj
TOX  sue
ARC
B, RESOURCE SUMMARY
POSITIONS PFT
LEVEL OPFT
02 OF n? FTE
BUDGET AUTH. (000.0)
FY 78 ACT FY
32.0
5.0

474.0
79 C. F. FY <
43.0
6.0
49.7
1,103.0
<0 INCP
10.0

5.0
261.7
FY 60 CUM
40,0
7.0
51.5

    C.  DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
       OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.
    Activities
    The primary program which will receive additional emphasis at this level is
    regional integration.  This level will allow the integration effort to be
    conducted at a level which is in proportion to the requirements of the
    larger regional  toxics programs (Regions II,  III, IV, V and VI).

    Greater amounts  of toxic chemical activity in some regions necessitate
    additional problem identification and assessment and monitoring in those
    regions to address their greater number of problems.  This level will provide
    additional resources for these needed activities in those regions.

    The States and localities in the regions with more toxics activity will also
    have more involvement in toxic substances related activities.  Those regions
    will increase their efforts to cooperate with these active State and local
    programs to exchange information and develop approaches to control on the
    greater number of problems they must address.

    Other program activities (industry assistance, public information, strategy
    and regulations  development, and cooperation with other Federal agencies)
    will be slightly increased in proportion to the greater workload.

    Impact
    Funding this level will provide a small increase above the base program for
    the five regions which have the greatest amount of chemical industrial
    activity.  This will allow these regions' efforts to be more in line with
    their relative workloads.  Increases to these regions will have the greatest
    impact on the national toxics program.  The programmatic impacts of level 1
    will increase in quantity and quality.

    Not funding this level will mean that some regions will have toxics programs
    which are quite  inadequate in relation to their workload and number of
    toxics problems.  Positive impacts from the regional program will be limited
    to the quality and quantity of those in level 1.
                                                                       OU5
  EPA Form 2410-11 (8-78)

-------
                   ENVIRONMENTAL  PROTECTION  AGENCY

FOR*  2! DECISION  UNIT  LEVEL  ANALYSIS
A,  DECIblUN UNIT  TITLE  AND CODE
L220  TOXICS MANAGEMENT
                RG
     AJ  TOX  SUB
APPRUs  A 8,  C
R.  RF.SOURCF  SUMMARY
         POSITIONS   PFT
 LEVFL               OPFT
03  OF  r-7             FTE
    BUDf-ET  AUTH.  (000.0)
FY  78 ACT  FY 79  C.  E.
      32.0          aj.O
       5,0           fo.O
                    49,7
     474.0      1,193.0
 FY  HO I NCR
         3.0

         1.5
FY  80 CUM
      43.0
       7,0
      53.0
   1,219.9
     C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
       OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.
     Activities
     Activities in almost all program  areas will be increased in the regions
     making  the most toxics program progress.  At this level, these regions will
     be able to strengthen their  efforts especially in high priority integration
     efforts and cooperation with-States and localities.  Problem identification
     and assessment and monitoring  activities in support of the overall  program
     will also receive greater emphasis.

     Impact
     Funding this level will provide a further increase to the base program for
     the regions and will allow further progress in implementation of the program.
     This will allow the regions' efforts to be more adequate in responding to
     their workload and toxics problems.  The positive impacts of levels 1
     and 2 will be further enhanced.

     Not funding this level will  mean  that the regions' progress in implementation
     will be constrained and their  programs will be less than adequate for their
     workload and problems.  The  quantity and quality of positive impacts will be
     limited to those at level 2.
        OH6
   EPA Form 2410-11 (8-78)

-------












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-------
                     ENVIRONMENTAL PROTECTION AGENCY

FORM!:  DECISION UNIT OVERVIEW
  A)  DECISION UNIT TITLE (AND CODE)                    HQ  OE      MEDIA:Toxic
                                                                      Substances
 TOXIC SUBSTANCES ENFORCEMENT (L305)              	**$•         APPROEnforcement
  B)  LONG RANGE GOALS & MAJOR OBJECTIVES The  fundamental  goal  of  the  Toxic  Sub-
 stances Enforcement Program is to procect  the  public  health  and the environment
 from risks posed by chemical substances through  enforcement  of  the  Toxic  Sub-
 stances Control Act of 1976 (TSCA) and regulations  promulgated  thereunder.
 Specific program objectives in support of  this goal include  development and
 implementation of inspectional and compliance  monitoring  programs to ensure
 compliance with TSCA; development and utilization of  appropriate remedies for
 the  enforcement of TSCA;  support for  Regional  case  preparations and prosecution
 initiated under authority of TSCA; and assistance to  the  Office of  Toxic  Sub-
 stances in the development of regulations  promulgated under  TSCA.
  Cl FY 78 ACCOMPLISHMENTS  Ma3or ^~^8 accomplishments  of  the  Toxic  Substances
 Enforcement Program' include:   delegation of  TSCA inspection and  enforcement
 authority to the Regional level;  development of  rules  of  practice governing
 enforcement and compliance related hearings  initiated  under TSCA; development
 of interim TSCA penalty policy; completion of a  feasibility study regarding
 TSCA enforcement automated data processing needs;  identification of Regional/
 HQ personnel/procedures to be used in coordinating response to toxic  substance
 emergencies; development of enforcement strategy,  compliance  monitoring  policy,
 and inspection procedures for the PCB Marking and  Disposal Regulation and  TSCA
 §8(b) Inventory; development of draft enforcement  strategy for PCB  Ban and
 Chlorofluorocarbon.Regulations; development  of initial chemical  import proce-
 dures .
  D)  FY 79 PROGRAM DESCRIPTION  Major py-79 activities  of  the  Toxic  Substances
 Enforcement Program include:   development of  final TSCA penalty policy;  comple-
 tion of  PCB Ban and Chlorofluorocarbon enforcement strategy,  compliance  monitor
 ing policy, and inspection proceduresJ development of final chemical  import
 procedures; support for Regional case preparations/prosecutions initiated under
 authority of TSCA;  assistance to the Office of  Toxic Substances in the develop-
 ment of  new regulations promulgated under TSCA;  identification of regulatory
 audience affected,  development of enforcement strategies, compliance  monitoring
 policies, inspections procedures, and Regional  implementation guidance for all
 new regulations developed under TSCA; establishment  of  cooperative enforcement
 agreements with selected States.
                                                                       cms
EFA Form 2410-10 (8-76)

-------
                             l.TAL PffOTPCTION AGENCY

      2? DECISION  UNIT  LEVEL  ANALYSIS
A.  DECISION UNIT  TITLE  AND  CODE          HQ       MEUIAj TOX  SUB
L305  TOXIC  SUBSTANCES  ENFORCEMENT                 APPPDj ENFORCEMENT
B,  RESOURCE SUMMARY       FY  78 ACT  FY  79 C. E.   FY  BO INCR    FY 80
         POSITIONS  PFT          23.0          31.0          ?3,0         23.0
 LEVEL              OPFT                         a.O           5.0           5.0
01  OF  no             FTE                        36.7          34. 1         3fl.l
    BUDGET  HJTH.  (000,0)        olb.O       2,196.9       1*353, b      1*353,6
     C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS

   ACTI^
 OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.
IVITIES
      Coordinate response and provide  direct assistance to Regional investigation
      and litigation of toxic substance  emergencies which threaten public health
      (Section 7, 8(e), and multi-media  emergencies).
        — Receive information;  trigger  National Contingency Plan; as appropriate
           alert -Agency management
        — Coordinate technical/legal  support
        — Assess situation; develop appropriate enforcement response
        — Coordinate Headquarters/Regional response

      Provide technical support  to the Regions for enforcement actions arising
      out of multi-media or toxic substance emergencies which threaten public
      health (Section 7, 8(e), and multi-media emergencies).  (NEIC).
        — Provide technical support to  Regions in the assessment of multi-media
           or toxic substance incidents  through computer-based data systems
           regarding chemical toxicity,  geographic distribution of chemical
           production, epidemiological effects, etc.
        — Collect and analyze enforcement samples in support of large-scale
           investigations
        — Provide technical advice and  expert testimony.in support of large-
           scale enforcement prosecutions

      Manage and execute national program to implement and enforce three 86 (Chemi-
      cal Control) regulations:   PCB Marking and Disposal, PCB Ban, and CFC Ban
      regulations.
        — Provide legal/technical interpretation regarding application of each
           rule
        — Establish national/situation  specific enforcement policy
        — Establish national compliance monitoring priorities
        — Participate, as appropriate,  in such implementation activities as site
           approval process (PCB Marking and Disposal); exemption process (PCB
           Ban)
     j-  — Coordinate Chemical Control Enforcement Program within EPA, with other
           federal agencies, and with  state and local governments.

      Manage and execute national program to implement and enforce the require-
      ments of Section 13 (Import) and Section 12 (Export) with regard to
      chemicals regulated under  Sections 5, 6, or 7.
        — Maintain liaison with Customs Bureau and other appropriate EPA offices
           to assure effective implementation of import policy
        — Provide, as appropriate, legal/technical interpretation regarding appli-
           cation of each rule
        ~r-?Stablish and communicate to  field-level Customs officials, national
         C Compliance monitoring and enforcement priorities
   EPA Form 2410-11 (8-78)

-------
                      ENVIRONMENTAL PROTECTION AGENCY
FORM 2: DECISION UNIT LEVEL ANALYSIS
  A.  DECISION UNIT TITLE {AND CODE)

  TOXIC  SUBSTANCES  ENFORCEMENT  (L305)
                    HQ

                    REG.
                        OE
MEDIA:Toxic
     Substances
APPRO:
                                                                      Enforcemeni
  B.  RESOURCE SUMMARY
FY 78 ACTUAL  FY 79 C. EST.   FY 80 INCR.
      FY80CUM.
LEVEL
-L-OF-&-
POSITIONS PFT
OPFT
FTE
BUDGET AUTH. (000.0)
















  C.  DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
     OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.
       —  Assess  international  inspection strategies and  procedures; identify
          international  impacts of domestic  enforcement policy

  o  Manage  and execute  national  program to  implement and enforce seven  Section
    4  (Testing)  regulations.
       —  Establish national compliance monitoring and enforcement priorities
       —  Establish national/situation specific  enforcement policy
       —  Provide legal/technical interpretation of application of each  testing
          rule
       —  Maintain liaison with FDA  for the  coordination  of the administrative
          and quality  assurance aspects of  each  investigation

  o  Provide substantive enforcement input  into  TSCA regulation development
    activities:   11 Section 6  (Chemical Control), 8 Section 4  (Testing), and
    2  Section  8  (Chemical Information) regulations.
       —  Assure  enforceability of regulations
       —  Identify enforcement  issues; raise issues to management
       —  Identify affected audience
       —  Develop national enforcement strategies
       —  Develop national inspection manual procedures

  o  Perform national  analysis  of records and reports submitted pursuant to PCB,
    CFC,  and Section  8  (Chemical Information) requirements, and review  the
    operation  of the  national  enforcement  program.
       —  Cross check  records/reports to detect  violations
       —  Readjust compliance monitoring priorities
       —  Review  Headquarters files  of Regional  compliance monitoring and enforce'
          ment  activities
       —  Adjust  national enforcement priorities to reflect major changes in
          compliance assumptions

  o  Provide support to  Regional  case preparation/prosecution activities for
   ^ 40 Section 6 (Chemical Control), 1 Section  4  (Testing) and 1 Section 8(a)
     (Chemical  Information) case, and for 10 cases arising out of multi-media
    or toxic substance  emergencies.
       —  Advise  the Regions regarding assessment of report, records, or results
          of sample analysis
       —  Confer  with  the Regions regarding the  selection of appropriate remedy,
          application  of enforcement criteria, and litigation strategy
       —  Advise  and assist Regions  in preparing documents and other materials
          for the prosecution of  the case,  arranging for  expert witnesses, pre-
          paring  witnesses for  testimony, conducting public hearing
                                                                         0151
EPA Form 2410-11 (8-78)

-------
                      ENVIRONMENTAL PROTECTION AGENCY
 FORM 2: DECISION UNIT LEVEL ANALYSIS
  A.  DECISION UNIT TITLE (AND CODE)
 TOXIC SUBSTANCES ENFORCEMENT  (L305)
HQ OE

REG.
                                MEDIA:Toxic
  B.  RESOURCE SUMMARY
FY 78 ACTUAL  FY 79 C. EST.   FY80INCR.
                   FY 80 CUM.
LEVEL
— L—OF--6—
POSITIONS PFT
OPFT
FTEj
BUDGET AUTH. (000.0!
















  C.  DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
     OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.
      — Advise and assist Regions in preparing briefs on all prehearing, post-
         hearing motions or proposed orders
      — Develop enforcement policy, appellate strategy and prepare all briefs
         and other documents as necessary to pursue any appeal of an initial
         decision of the Regional Administrator

 o  Participate directly in the case preparation/prosecution of 2 criminal
    cases, and in the appellate review of 3 civil enforcement actions.
      — Participate with FBI, Regions on investigation team for development
         of evidence, and case preparation of criminal cases
      — Participate with DOJ, OGC on litigation team in development of litiga-
       - tion strategy and prosecution of criminal cases, and appeal of civil
         enforcement actions
      — Maintain close liaison with DOJ to expedite subpoenas, warrants, dis-
         covery, case preparation/prosecutions of criminal cases, and appeals
         of civil enforcement actions

 o  Respond to suits filed pursuant to Section 20 (Citizens' Civil Actions)
    designed to compel the Administrator to perform nondiscretionary function.
      — Establish litigation strategy for suits filed against: third parties to
         compel compliance with TSCA
      — Determine appropriate enforcement policy in suits filed against the
         Administrator to compel a nondiscretionary action
      — Take all actions to prepare pleadings, motions, and briefs as necessary
         to pursue actions filed against the Administrator

 o  Manage national inspection/sample analysis contract designed to support
    Regional inspection/sample analysis functions.
  IMPACT
      — Funding  establishes baseline toxic enforcement program.  Regional
         support  to  case  preparation/prosecution and emergency response  is
         provided; National enforcement program is managed.  OTS regulation
         development activities are supported.  Minimal data analysis/program
         evaluation  function is performed.
      — Not  funding terminates Headquarters  toxic enforcement role.   Regional
         case support and national program direction is not provided;  Regions
         are  forced  to operate in a national  enforcement  policy vacuum.   Termin-
         ation of support of regulation development prevents assessment  of new
         regulations for  enforcement implications.
EPA Form 2410-11 (8-78)

-------
                                AL PROTECTION AGENCY

FORM  n DECISION u*'IT  LEVEL  ANALYSIS

A.  DECISION UNIT TITLE AND  COPE          H&       MfcPl M
L305  TOXIC  SUBSTANCES  ENFORCEMENT                 APPRC'I

B.  RESOURCE SUMMARY       FY  78 ACT FY  79 c".  E~" F Y'^O
         POSITIONS  PFT         23.o         31.0           5.0         38.0
 LEVEL              HPFT                        4.0           4.0           9 0
0?  nF  06             FTF                       36,7           8,2         ag.3
            AUTH.  (000.0)        6J6.0      2,198.9        356.1      1,709.7
   C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
      OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.
  ACTIVITIES
   o  Audit, appraise and evaluate the national TSCA enforcement program and
     adjust enforcement strategies and compliance monitoring priorities as
     necessary
       — Conduct field level review of five  selected Regional programs to assess
          understanding of and adherence to Headquarters guidance regarding
          enforcement criteria, penalty policy,  and compliance monitoring and
          enforcement priorities
       — Procure and manage contract to support the evaluation and revision of
          enforcement strategies which are in the most urgent need of amendment

   o  Provide support to Regional case preparation/prosecution activities for 19
     additional Section 6 (Chemical Control)  cases, and 1 additional Section
     . 8(a) (Chemical Information) case.
       — Advise the Regions regarding assessment of reports, records, or results
          of sample analysis
       — Confer with the Regions regarding the  selection of appropriate remedy,
          application of enforcement criteria, and litigation strategy
       — Advise and assist Regions in preparing documents and other materials
          for the prosecution of the case, arranging for expert witnesses, pre-
          paring witnesses for testimony,  conducting public hearing
       — Advise and assist Regions in preparing briefs on all prehearing, post-
          hearing motions or proposed orders
       — Develop enforcement policy, appellate  strategy and prepare all briefs
          and other documents as necessary to pursue any appeal of an initial
          decision of the Regional Administrator

   o  Participate in litigation activities arising out of 1 Section 5(f) (Unrea-
     sonable Risk) order.
       T- Assist OTS and OGC in the development  of litigation strategy
       — Participate on litigation team by preparing and presenting in court
          that part of the case dealing with  (a) the remedies sought by EPA
    .V     including the feasibility of implementing and monitoring compliance
          with such remedies, and (b) the impact upon the firm and the industry
          of implementing the remedy

   o  Provide substantive enforcement input into  TSCA regulation development
     activities:  2 additional Section 6 (Chemical Control) and 1 additional
     Section 4 (Testing) regulation.
       — Assure enforceability of regulations
       — Identify affected audience
       — Develop national enforcement strategies
       — Develop national inspection and case preparation procedures
 EPA Form 2410-11 (8-78)

-------
                      ENVIRONMENTAL PROTECTION AGENCY
FORM 2: DECISION UNIT LEVEL ANALYSIS
  A.  DECISION UNIT TITLE (AND CODE)

 TOXIC SUBSTANCES ENFORCEMENT  (L305)
                    HQ OE       MEDIA:
                                      Substances
                    REG.         APPRO:Enforcement
  B.  RESOURCE SUMMARY
FY 78 ACTUAL  FY 79 C, EST.   FY 80 INCR.
FY80 CUM.
LEVEL
2 6
	 OF 	

POSITIONS PFT
OPFT
FTE
BUDGET AUTH. (000.0)
















  C.  DESCRIBE THE INCREMENTAL ACTIVITIESOF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
     OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.

 o  Provide technical support  to  the Regions for major  enforcement  actions
    arising out  of Section  6  (Chemical Control) regulations.   (NEIC).
      — Collect and analyze enforcement samples in support of  large-scale
         investigations
      — Provide technical  advice and expert testimony  in  support of  large-scale
         enforcement prosecutions
 IMPACT
      — Funding increases NEIC and Headquarters case  support  for Regional
         enforcement actions commensurate with Regional projections.   Support is
         provided for additional OTS regula'tion development  activities and pro-
         jected Section 5(f) litigation budgeted at  this  level.  Program evalua-
         tion function is increased and focuses on audit  of  Regional  programs
         and revision of national chemical control enforcement strategies.
      — Not funding provides no support to projected  increase in Regional
         enforcement actions and OTS regulation development.  Monitoring of
         Regional adherence -to national enforcement  policy is  inadequate;  NEIC
         technical case support is limited to emergency episodes.
EPA Form 2410-11 (8-78)

-------
FORM  c1: DECISION  UNIT  LEVEL  ANALYSIS
A,  DECISION UNIT TITLE  AMD  CODE          HQ       MgDJ/n  TO* SUB
L305  TOxIC  &UBSTANCES  ENFORCEMENT                 APPROi
6,  RESOURCE SUMMARY       FY  78  ACT FY  79 c.  E.  FY  PO  INCR    FY BO  cu*
         POSITIONS  PFT          23.0         31.0           3.0         31.0
 LEVEL              QPFT                          a.O           4.0         13.0
03  OF  Ofc,             FTE                        Jfc.7           7,2         49.5
    BljnGET  AUTH,  CuOO.o)        616.0      2,106.9        4P9.2      2»198,9
   C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
      OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.
  ACTIVITIES
     Provide support to Regional case preparatiqn/prosecution activities for 27
     additional Section 6 (Chemical  Control) cases, 1 Section 8(e) (Substantial
     Risk) case, 1 Section 5 (a)  (Premanufacture Notification) case,  and 1 Section
     13 (Imports) case.
       — Advise the Regions regarding assessment of reports, records,  or results
          of sample analysis
       — Confer with the Regions regarding the selection of appropriate remedy,
          application of enforcement criteria, and litigation strategy
       — Advise and assist Regions  in preparing documents and other materials
          for the prosecution of the case, arranging for expert witnesses, pre-
          paring witnesses for testimony, conducting public hearing
       — Advise and assist Regions  in preparing briefs on all prehearing, post-
          hearing motions or proposed orders
       — Develop enforcement policy, appellate strategy and prepare all briefs
          and other documents as necessary to pursue any appeal of an initial
          decision of the Regional Administrator

     Participate in litigation activities arising out of one additional Section
     5(f) (Unreasonable Risk) order.
       — Assist OTS and OGC in the  development of litigation strategy
       — Participate on litigation  team by preparing and presenting in court
          that part of the case dealing with (a) the remedies sought by EPA,
          including the feasibility  of implementing and monitoring compliance
          with such remedies, and (b) the impact upon the firm and the industry
          of implementing the remedy

     Develop and implement cooperative enforcement agreements with 3 selected
     States.
       — Prepare program-specific regulations establishing criteria and admini-
          strative procedures for allocating funds to States for Cooperative
          Enforcement Agreements
       — Assist Regions in negotiating specific outputs for Cooperative Enforce-
          ment Agreements, consistent with national policy
      * — Monitor the performance of States under Cooperative Enforcement Agree-
          ments

     Audit, appraise and evaluate the Federal/State Cooperative Enforcement
     Program.
       — In conjunction with appropriate Regions, conduct record and field-level
          review of FY-79 Cooperative Programs to assess the extent to which State
          performance is consistent  with and furthers the national program objec-
            tives
 EPA Form 2410-1) (8-78)

-------
                      ENVIRONMENTAL PROTECTION AGENCY
FORM 2: DECISION UNIT LEVEL ANALYSIS
  A.  DECISION UNIT TITLE (AND CODE)

 TOXIC SUBSTANCES ENFORCEMENT (L305)
                    HQ

                    REG.
MEDIA:

APPRO:
  Toxic
Substances
Enforcement
  B.  RESOURCE SUMMARY
FY 78 ACTUAL  FY 79 C. EST.   FY80INCR.
      FY80CUM.
LEVEL
-2.0F-1
POSITIONS PFT
OPFT
FTE
BUDGET AUTH. (000.01
















  C.  DESCRtBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
     OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.
      — Review and amend Regional guidance as necessary to improve Federal/
         State Cooperative Enforcement Program .

 D  Provide substantive enforcement input into TSCA regulation development
    activities:  5 additional Section 6 (Chemical Control)  regulations,  and 1
    additional "Section 8 (Chemical Information)  regulation.
      — Assure enforceability of regulations
      — Identify enforcement issues; raise issues to management
      — Identify affected audience
      — Develop national enforcement strategies
      — Develop national inspection and case  preparation procedures

 5  Provide technical support to the Regions on demand for enforcement actions
    arising out of Section 6 (Chemical Control), Section 5 (Premanufacturing),
    (Unreasonable Risk), and Section 4 (Testing) regulations.  (NEIC).
      — Collect and analyze enforcement samples in support of technically
         complex investigations
      — Provide technical advice and expert testimony in support of technically
         complex enforcement prosecutions
 IMPACT
      — Funding increases NEIC and Headquarters case support for Regional
         Enforcement actions commensurate with Regional projections.   Support is
         provided for additional OTS regulation development activities and
         additional Section 5(f) litigation budgeted at this level.   Cooperative
         State enforcement agreements are added and supplement Regional inspec-
         tion resources.   State performance of FY 79 cooperative agreement
         program is evaluated.
      — Not funding provides no support to projected increase in Regional
       .  enforcement actions and OTS regulation development.  Opportunity to
         expand inspection resources through State agreements is precluded;
         forces entire inspection burden upon Regional resources.  Identifica-
         tion of substandard FY 79 State grant performance is not accomplished;
         may result in continuation of ineffective funding.
       0155*
EPA Form 2410-11 (8-78)

-------
                   EN'Vi^ctN'-'s.NTAL PROTECTION AGENCY

FORM  2: DECISION UNIT  LEVEL  ANALYSIS
 ,  DECISION UNIT  TITLE  AMD  CODE          HQ       MEDIA}  TOX SUB
 305  TOXIC  SUBSTANCES  ENFORCEMENT                 APPRO*  ENFORCEMENT
B,  RESOURCE SUMMARY       FY  76 ACT FY  79 C.  E.  FY BO  INCR    FY 80  CUM
         POSITIONS  PFT          23.0         33.0           3.0          3«.0
 LEVEL              OPFT                          «.o           i.o          i«,o
04  OF  Ot>             FTE                        36.7           4,5          5«.0
    BUDGET  AUTH.  (000.0)       616.0      2,198.9        201.5      ?,400.4
    C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
      OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.
   ACTIVITIES
      Provide  support to Regional case preparatidn/prosecution  activities for 20
      Section  6  (Chemical Control) cases, 2 Section 4 (Testing)  cases, 1 Section
      8(a)  (Chemical Information) case, and 1 Section 8(e)  (Substantial Risk) case
        —  Advise  the Regions regarding assessment of reports,  records, or results
           of  sample analysis
        —  Confer  with the Regions regarding the selection  of appropriate remedy,
           application of enforcement criteria,  and litigation  strategy
        —  Advise  and assist Regions in preparing documents and  other materials
           for the prosecution of the case, arranging for expert witnesses, pre-
           paring  witnesses for testimony, conducting public hearing
        —  Advise  and assist Regions in preparing briefs  on all  prehearing, post-
           hearing motions or proposed orders
        —  Develop enforcement policy, appellate strategy and prepare all briefs
           and other documents as necessary to pursue any appeal of an initial
           decision of the Regional Administrator

      Participate  in litigation activities arising out of 1 Section 5(f) (Unrea-
      sonable  Risk) order, and 1 Section 5(e) (Insufficient Data)  order.
        —  Assist  OTS and OGC in the development of litigation  strategy
        —  Participate on litigation team by preparing and  presenting in court that
           part  of the case dealing with (a) the remedies sought by EPA, including
           the feasibility of implementing the remedy and monitoring compliance
           with  such remedies, and (b) the impact upon the  firm and the industry
           of  implementing the remedy

      Provide  substantive enforcement input into TSCA regulation development
      activities:  3 additional Section 6 (Chemical Control) regulations, 2 addi-
      tional Section 4 (Testing) regulations, and 1 Section 5  (Significant New Use)
      rule.
        —  Assure  enforceability of regulations
        —  Identify enforcement issues; raise issues to management
        —  Identify affected audience
       . —  Develop national inspection and case preparation procedures
   IMPACT
        — Funding increases case support for Regional enforcement  actions commen-
           surate with Regional projections.  Support is provided for additional
           OTS  regulation development activities and additional  Section 5(e),  (f)
           litigation budgeted at this level.
        — Not  funding provides no support to projected increase in Regional enfore
           ment actions and OTS regulation development.
  EPA Form 2410-11 (8-78)

-------
                            Łf> TAL PROTECTION

FORK;  2: DECISION  UNIT  LEVEL
A,  DECISION IWIT  TITLE  AND  CODE          HQ       MŁUIA| TO*  SUB
L3o5  TOXIC  SUBSTANCES  ENFORCEMENT                 APPRO* ENFORCEMENT

B,  RESOURCE SUMMARY       F-Y  78 ACT  FY  79 c. E.   FY  eo INCR   FY so  CUM
         POSITIONS  PFT          23.0          31.0           3.0         37.0
 LEVFL              OPFT                         «.0                        la.u
05  OF  ^&             FTE                        36.7           3.0         57.0
    BUDGET  AUTH.  (G('C.O)        616.0       2,196.9         259.6      2*660.2
   C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
      OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.
  ACTIVITIES
  o  Participate in litigation activities arising out of 1 additional Section 5(f)
     (Unreasonable Risk)  order,  and  1  Section 5(e) (Insufficient Data)  order.
       — Assist OTS and  OGC in the  development of litigation strategy
       — Participate on  litigation  team by preparing and presenting in court
          that part of the case dealing with (a) the remedies sought by EPA,
          including the feasibility  of implementing and monitoring compliance
          with such remedies,  and  (b)  the impact upon the firm and the industry
          of implementing the  remedy

  o  Expand effort to audit, appriase  and evaluate the national TSCA enforcement
     program and adjust enforcement  strategies and compliance monitoring priori-
     ties as necessary.
       — Conduct field level  review of 5 additional Regional programs to assess
          understanding of and adherence to Headquarters guidance regarding
          enforcement criteria,  penalty policy, and compliance monitoring and
          enforcement priorities

  o  Develop and implement Cooperative Enforcement Agreements with 2 additional
     States.
       — Assist Regions  in negotiating specific outputs for Cooperative Enforce-
          ment Agreements, consistent  with national policy
       — Monitor the performance  of States under Cooperative Enforcement Agree-
          ments

  o  Prepare and publish  four  TSCA Enforcement Policy Statements to publicize
     major enforcement policy  determinations.
       — Identify enforcement issues  of general applicability requiring a policy
          statement
       — In consultation with OTS and OGC, develop issue-specific enforcement
          policy, and draft Federal  Register notices

  o J-Participate directly in the case  preparation/prosecution of 1 additional
     criminal case, and in the appellate review of 1 additional civil enforcement
     action.
       — Participate with FBI,  Regions on investigation team for development of
          evidence, case  preparation of criminal cases
       — Participate with DOJ,  OGC  on litigation team in development of litigatioi
          strategy and prosecution of  crminal cases, and appeal of civil enforce-
          ment actions
       — Maintain close  liaison with  DOJ to expedite subpoenas, warrants, dis-
          covery, case preparation/prosecutions of criminal cases, and appeals of
               ' enforcement actions.
 EPA Form 2410-11 (8-78)

-------
                      ENVIRONMENTAL PROTECTION AGENCY
FORM 2: DECISION UNIT LEVEL ANALYSIS
  A.  DECISION UNIT TITLE (AND CODE)
   TOXIC  SUBSTANCES  ENFORCEMENT (L305)
                    HQ  OE

                    REG.
MEDIA -Toxic
     .  To	
     'Substances
APPRO5nforcement
  B.  RESOURCE SUMMARY
FY 78 ACTUAL  FY 79 C. EST.   FY 80 INCR.
      FY 80 CUM.
LEVEL
5 6
	 OF 	
LPOSITIONS PFT
OPFT
FTE
BUDGET AUTH. (000.0)
















     DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
     OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.
    Provide substantive enforcement input  into TSCA regulation development
    activities:  2 additional Section  6  (Chemical  Control) regulation and 1
    additional Section 5  (Significant  New  Use) regulation.
      — Assure  enforceability of regulations
      — Identify  enforcement issues;  raise issues to management
      — Identify  affected audience
      — Develop national enforcement  strategies
      — Develop national inspection and case preparation procedures
 IMPACT
      — Funding provides support for additional OTS regulation development
         activities and additional Section 5(e),  (f) litigation budgeted at  this
         level.  Additional  cooperative enforcement agreements with  States are
         added  to supplement Regional inspection resources.  Audit/evaluation of
         TSCA enforcement program is expanded  to include 5 additional Regions.
         TSCA enforcement policy statements are introduced as a means to educate
         the TSCA regulation audience concerning major  enforcement policy deter-
         minations
      — Not funding provides no support  to additional  OTS regulation develop-
         ment activities.  Regional audit program is limited to selected Regions
         this effectively delays substantive program evaluation activities which
         must be performed to adjust compliance monitoring strategies.  Innova-
         tive tool of TSCA enforcement policy  statements is eliminated  and resu!
         in inefficiencies regarding transmittal of enforcement policy  to TSCA
         regulatory audience.
                                                 :s
EPA Form 2410-1 1 (8-78)

-------



















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-------
                     ENVIRONMENTAL PROTECTION AGENCY
FORM 1:  DECISION UNIT OVERVIEW
 A)  DECISION UNIT TITLE (AND CODE)
 TOXIC  SUBSTANCES ENFORCEMENT  (L305)
HQ          MEDIA:  Toxic
                  Substances
REG. XX     APPROrEnforcemen
  B)  LONG RANGE GOALS & MAJOR OBJECTIVESThe fundamental goal  of  the  toxic sub-
 stances enforcement program is to protect the public health and  the  environment
 from risks posed by chemical  substances through enforcement of the Toxic Sub-
 stances Control Act of  1976 (TSCA)  and regulations  promulgated thereunder.
 TSCA and its regulations will establish boundaries  for the  risks posed by
 selected chemicals and  define acceptable activity which restricts  chemical
 risks to those boundaries.  The major enforcement program objective  then
 becomes the implementation of a compliance monitoring effort that  detects
 activity beyond those boundaries and prosecutes responsible parties  as appro-
 priate.
  C)  FY 78 ACCOMPLISHMENTS
                           FY-78 was the intial "start-up" year  of  the Regional
 toxic substances enforcement program;  few TSCA regulations existed to be
 enforced in that year.   Consequently,  Regional activity during  FY-78  focused
 primarily on supporting the development of integrated toxic substances control
 plans.   These plans are designed to identify the manner in which TSCA authori-
 ties can most effectively be utilized  as a supplement to other  EPA toxic  contro
 statutes to produce a cohesive and comprehensive toxic substances  control effor
 In addition, in the latter portion of  FY-78, several TSCA S8(e)  (Substantial
 Risk) investigations were in progress.   These investigations will  determine
 whether companies or individuals failed to notify EPA regarding potential risks
 posed by certain chemical substances.
  D)  FY 79 PROGRAM DESCRIPTION ^g 57.79 Regional toxic substances  enforcement
 program  includes two major areas of enforcement activity:   emergencies  and
 chemical control.  As emergency incidents occur enforcement personnel are
 responsible for investigating those incidents to determine if  it  is  appropriate
 to initiate legal action under authority of TSCA against the parties alleged
 to be responsible for the incident.  Enforcement activity of a more  routine,
 continuous nature includes a compliance monitoring effort regarding  86  ChemicaJ
 Control  regulations.  FY-79 Chemical Control regulations consist  of  the PCS
 Marking  and Disposal, PCB Ban, and Chlorofluorocarbon Ban Regulation.  Enforce-
 ment will monitor compliance with the requirements of these regulations and
 initiate enforcement actions upon detection of violations.  Other elements  of
 the FY-79 Regional program include compliance monitoring and enforcement of the
 TSCA 813 requirements imposed on chemicals imported into the United  States; in-
 vestigation of noncompliance with TSCA 88(e) regarding notification  to  EPA  of
 chemicals which may present a substantial risk to the public;  and assistance in
 the negotiation of cooperative State enforcement agreements.
                                                                        0163
EPA Form 2410-10 (8-78)

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                   ENVIRONMENTAL PROTECTION  ASFNCY
FORM  2{ DECISION UNIT  LEVEL  ANALYSIS
A,  DECISION UNIT TITLE  AND CODE          R&       MEDIAj TO*  SUB
L305  TC'XIC  SUBSTANCES  ENFORCEMENT                 APMRPi
B.  RFSOURCF SUMMARY       FY  76 ACT  FY  79 C. E,   FY  60 INCR   FY 80  CUM
         POSITIONS  PFT          25.0          30.0          29,0         29,0
 LEVEL              OPFT           i.o            i.o            1,0           i.o
01  OF 07             FTE                        36,0          35.4         35, fl
    BUDGET  AUTH,  (000,0)        «84.0       1,034.3         759,2        759,2
    C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
      OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.
  ACTIVITIES
       At this level all Regions  are  allocated a- minimal Toxic Substances  enforce-
       ment staff.  Resources allow performance of two fundamental program activi-
       ties:  emergency response  and  chemical control enforcement.  The emergency
       response activity involves the legal investigation of toxic substance emer-
       gency incidents for the purpose of determining the propriety of initiating
       an enforcement action under authority of TSCA against parties alleged to be
       responsible for such incidents.  This activity represents the top program
       priority at all levels. However, it is not anticipated that resources at
       this level will be completely  allocated to this activity.  Rather,  emer-
       gency incidents will occur from time to time with unpredictable frequency.
       On these occasions investigation and subsequent litigation activities
       regarding emergency incidents  will be performed.

       Activity of a more predictable and routine nature includes compliance moni-
       toring and enforcement of  TSCA §6 chemical control regulations.  In FY-80
       three such regulations will be in place:  the PCB Marking and Disposal, PCB
       Ban, and Chlorofluorocarbon Ban regulations.  Regional activity will includ
       performance of on-site inspections on facilities subject to the requirement;
       of these regulations; and  subsequent initiation of enforcement actions upon
       detection of regulatory violations.  Within this category of activity
       compliance monitoring and  enforcement of the PCB regulations is the major
       priority and will require  the  bulk of compliance resources.  Chlorofluoro-
       carbon compliance activity will generally only be initiated at the  Regional
       level upon referral of information from Headquarters concerning the necessi
       ty of performing an inspection.  Resources at this level allow for  inspec-
       tions of approximately 59% of  high priority PCB facilities.
   IMPACT
       — Funding establishes baseline Regional toxic substances enforcement
          program.  Resources provide for  emergency response and chemical control
          enforcement activity.   A measurable but limited enforcement presence is
          established nationwide.
       — Not funding eliminates TSCA enforcement function at the Regional level.
          No inspections of facilities subject to TSCA requirements occur.  Emer-
          gency investigations and enforcement actions are not initiated.
         018 »t
  EPA Form 2410-11 (8-78)

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                                   PROTECTION'  AGENCY
FORM  dt DECISION  UNIT  LEVEL  ANALYSIS
A.  DECISION UNIT  TITLE  AND CODE         RG        MEDIAt  TOX  SUB
L305  TOXIC  SUBSTANCES ENFORCEMENT                 APPRO!  ENFORCEMENT
R, RESOURCE SUGARY
POSITIONS PFT
LEVEL OPFT
02 OF 07 FTE
BUDGET AUTH, (000.0)
FY 78 ACT FY
25.0
I."

484.0
79 C. E.
39.0
1.0
38.0
1,034.3
FY 80 INC«
6.0

3.0
246.5
FY BO CUM
35.0
1.0
36,4
1,005.7
    C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
      OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.

   ACTIVITIES
        The primary  output of this level is an increase  in the TSCA §6 compliance
        monitoring and  enforcement effort.  Additional resources allow additional
        facility inspections and enforcement actions  to  be performed.  Resources
        allow for inspection of 69% of high priority  PCB facilities.  Additional
        activities include providing enforcement support for implementation of
        the Regional toxic substances control plans and  initiation of efforts to
        induce voluntary industry compliance with TSCA.  Performance of these
        additional activities will vary from Region to Region as chemical control
        inspection schedules and workload allow; priority activity at this level
        remains attainment of PCB inspection "output target.
   IMPACT
        — Funding broadens TSCA §6 compliance net  by  providing additional inspec-
           tions of major PCB facilities.
        — Not funding  limits TSCA 86 inspections to Level 1 output.
                                                                   0165
  EPA Form 2410-11 (8-78)

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                   ENVIRONMENTAL  PROTECTION  AGENCY
FORM  2: DECISION  UNJT  LEVEL  ANALYSIS
A.  DECISION UNIT  TITLE  AND CODE         RG       MEPIAj  TOX  SUB
L305  TOXIC  SUBSTANCES  ENFORCEMENT                APPRO*  ENFORCEMENT
B. RESOURCE SUMMARY
POSITIONS PFT
LEVEL OPFT
03 OF 07 FTE
BUDGET AUTM. (000,0)
FY 78 ACT FY
25.0
l.o

484,0
79 C. E.
39.0
1.0
38,0
1,034,3
FY BO I NCR
6,0

4.0
139,7
FY 80 CUM
41.0
l.o
43.4
1,145.4
    C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
      OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.
   ACTIVITIES
        Regions  attain resources to perform inspections on 82% of high priority
        PCB facilities.  In addition,  resources  allow for minimal compliance moni-
        toring and enforcement activity regarding TSCA 84 testing requirements,
        88 chemical information reporting requirements, and 813 imported chemical
        requirements.  Regional activity in these areas will be low in relation to
        86 chemical control enforcement activity.  Section 4, 8, 13 inspections
        and follow-up actions will generally be  initiated only in response to case
        referrals from Headquarters.  However, activity in these areas will occur
        on a relatively regular basis.  Attainment of PCB facility inspection out-
        put target remains top priority at th'is  level.
   IMPACT
        — Funding  increases PCB facility inspection coverage.  TSCA compliance
           broadened beyond chemical control requirements to include other major
           requirements of the Act.
        — Not funding jeopordizes attainment of  TSCA 86 major PCB facility inspec-
           tions.   No enforcement beyond chemical control requirements occurs.
            016S
  EPA Form 2410-11 (8-78)

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                PESTICIDES MEDIA



                    CONTENTS


                                          PAGE

A.   MEDIA RESOURCE SUMMARY	     169

B.   MEDIA OVERVIEW	     170

C.   MEDIA RANKING	     179

D.   BUDGET  REQUEST BY DECISION UNIT      182

E.   DECISION  UNIT DESCRIPTIONS AND
     LEVELS

          RESEARCH AND DEVELOPMENT-..     186

          ABATEMENT AND CONTROL	     225

          ENFORCEMENT	     297

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                 ENVIRONMENTAL PROTECTION AGENCY

                       FY 1980 OMB REQUEST

                           Pesticides
                     Media Resource Summary
                             FY 1979           FY 1980           Change
                                     (dollars in thousands)
Research & Development

Permanent Positions	    132
Budget Authority	  9,898.2

Abatement & Control

Permanent Positions	    727
Budget Authority	 42,551.7

Enforcement

Permanent Positions	    146
Budget Authority	 13,051.3
Total

Permanent Positions	  1,005
Budget Authority	 65,501.2
   152
11,293.0
   788
40,131.2
   118
13.058.7
   +20
+1,394.8
   +61
-2,420.5
   -28
    +7.4
 1,058
64,482.9
   +53
-1,018.3

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                          PESTICIDES MEDIA OVERVIEW
     I.  OVERVIEW AND STRATEGY

         The objective of the pesticide program is to protect  the public
     health and the environment from unreasonable  pesticide  risks while per-
     mitting the introduction of necessary pest control  technologies.   This
     objective is pursued through four principal means:   (1) review of
     existing and new pesticide products,  which provides the principal  means
     for safeguarding public health, (2) use management, (3) enforcement,  and
     (4) research and development.

         Review

         New pesticide products are reviewed and registered  upon a finding
     that the product will not pose unreasonable risks to humans or the
     environment, taking into consideration the economic,  social, and envir-
     onmental costs and benefits stemming  from use of the pesticide.  The
     1972 amendments to the Federal Insecticide, Fungicide and Rodenticide
     Act (FIFRA) contain the basic provisions for  the review and registration
     of pesticides.

         The 1972 amendments require the review and reregistration of all
     33,000 Federally and 7,500 State-registered products now  on the market,.
     Most of these existing products were  originally registered before  the
     chronic effects of exposure to toxic  chemicals were thoroughly under-
     stood and prior to enactment of the 1972 amendments.  Their registration
     thus requires a more thorough review  of all test data for both acute  and
     chronic effects, a process that requires a much higher  level of resources
     than was required for the original registration effort.   Evidence  has
     surfaced that some of the original data used  for registration was  based
     upon health effects testing that was  not consistent with  current day
     scientific standards, or that was conducted in a questionable or even
     fraudulent manner.  This, too, calls  for a more in-depth  review of the
     data before registration can be accomplished.

         The FY 1980 budget is based upon  the presumption that the proposed
     amendments to FIFRA will be enacted.   If the  Act is not changed, the
     budget estimates and the planned FY 1980 outputs will require revision.

         In order to use resources efficiently, the Agency has developed a
     new approach to reregistration—developing generic  standards for each
     of the chemicals currently used in pesticide  products.  While there
     are about 1,400 possible chemicals for which  standards  could be developed,
     EPA will concentrate its efforts on the 514 chemicals currently used  as
     active ingredients in registered products.  (The list of  1,400 was first
     reduced to 991 chemicals by grouping  together several constituents of
     active ingredients, such as salts, acids,  and esters, and then to  514
     chemicals by eliminating those chemicals not  currently  used in pesticide
     products or treated as "inert" ingredients).   Several mixture and

0170

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formulation standards will be developed for each chemical standard pro-
duced.  Residue tolerances, previously established under authority of
the Federal Food, Drug and Cosmetic Act, will also be reviewed and
specified for each of the food or animal feed crops to which the chemical
is applied.  Finally, all pesticide products that use the chemical as
an active ingredient and meet the stipulations of the standard will be
reregistered.

    Production of generic standards will begin in Fiscal Year 1979 —
made possible by the increase to Office of Pesticide Programs resources
that was included in the Fiscal Year 1979 budget.  A prototype standard,
for the chemical metolachlor, was completed in Fiscal Year 1978.

    To remove quickly from the market those pesticides that pose an ad-
verse risk, a special program, Rebuttable Presumption Against Registra-
tion (RPAR), has been developed.  Under this program, suspect chemicals
are subjected to focused benefit/risk assessment.  Much of the benefit
data for this assessment is developed by the Department of Agriculture
and the Department of Interior.  There are currently 65 chemicals on the
RPAR list.  Agency decisions have been made on one chemical (17 other
chemicals have been voluntarily withdrawn from the market after dis-
closure of risk through the RPAR process), and reviews will be completed
on another 23 products in Fiscal Year 1979.

    Other programs which are key elements of the program to review pesti-
cide products include the following.

    1.  Registration, which enables new products to enter the market.
Under this program, new pesticide products are registered, and current
registrations are amended for new uses or new formulations.  Registration
activity will increase in Fiscal Years 1979 and 1980 for two principal
reasons:  clarification of the trade secret provisions of FIFRA, through
the soon-to-be-enacted amendments, and implementation of the conditional
registration provision of the new amendments.  This change will permit
products, especially those containing old active ingredients, to be
registered under simplified procedures before a generic standard is
developed.

    2.  Special Registration, which covers all activities relating to
the issuance of experimental use permits under section 5 of FIFRA to
generate data for registration, the issuance of emergency exemptions
under section 18, and the issuance of Section 24(c) special local need
registrations, which are handled largely by the States with Federal
oversight.

    3.  Tolerances, which provides for the establishment of pesticide
residue tolerances on food and animal feed crops under the Federal Food,
Drug and Cosmetic Act.
                                                                     0171

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           4.  Laboratory Audits, which allow laboratories that perform animal
       toxicity and chronic effects testing for applicants and registrants to
       be audited to confirm that their procedures are sound and that their
       test results are valid.

          Use Management

          The second major element of the pesticide program is use management.
       Pesticides are classified, based upon their potential harm through mis-
       use, for either restricted or general use.  Only trained and certified
       applicators may apply pesticides classified for restricted use.  The
       training and certification of applicators, either private or commercial,
       is a task managed largely by the States.  To date, all but two States
       (Colorado and Nebraska) have elected to assume the program, with Federal
       financial assistance.  EPA operates the certification and training pro-
       grams in these two states.

          Enforcement

          The pesticides enforcement program is designed to support the objec-
       tives of regulating pesticide supply and use.  The program emphasizes
       increased State involvement through Federal/State cooperative enforce-
      ment grants.  Through such grants, the States are able to support compre-
       hensive enforcement programs and bring local expertise into the national
       regulatory effort.  In FY 1980 EPA will continue its efforts to in-
      volve most or all of the States and Territories in this program.  Enforce-
      ment activities, either carried out by participating States, or by EPA in
       those States not having grants, will focus on the general areas of in-
       suring industry compliance with registration, classification, and labeling
       requirements.  Criminal investigations will continue on alleged data
       fraud in private testing laboratories.

          Research and Development

          The research program places emphasis on three basic elements necessary
       to evaluate overall human health and environmental hazards from pesticides:
       (1) identification of the population at risk, (2) assessment of individual
      exposure, and (3) determination of adverse effects.  To make hazard
      estimates in any given situation, there is a need for quantitative esti-
      mates for each of these elements.  Registrants have already provided
      much data on adverse effects.  Although there is a continuing need for
      effects research, particularly on new compounds, first priority will be
      placed on exposure assessment, because there is currently little data
      available on this topic.  Exposure assessment research will cover the
      development of protocols to determine occupational exposure to pesticides
      through their use, general population exposure through all media, and
      exposure of nontarget fish and wildlife.  In addition, and as called for
      in FIFRA, the pesticide management program is developing "biologically
      integrated alternatives" to chemical pesticides to control agricultural
      and urban pests (primarily insects and weeds).  As these are integrated
      with other pest control practices (including chemical pesticides), they
0172

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comprise an integrated management research program.   Finally,  in FY 1980
additional emphasis will be given to the quality assurance program.

II. RANKING CRITERIA AND PRIORITIES

    The ranking criteria and priorities that guided  the development of
the pesticide program for Fiscal Year 1980 are the following.

    •  Prepare generic pesticide registration standards,  including the
       reassessment of tolerances, and develop procedures to integrate
       with the RPAR process.   Develop protocols for exposure  assessment
       and effects assessment for human health and the environment,
       and test compounds of interest when required  for regulatory
       purposes.

    •  Implement a conditional registration program  and process new
       registration applications in an efficient,  effective manner,
       giving priority to innovative, environmentally protective com-
       pounds.  Develop protocols for registration of biological and
       other third generation pest control technologies.

    •  Review benefits and risks of compounds identified as posing
       potentially unreasonable adverse effects, reach final risk/
       benefit determinations, and reduce health and environmental im-
       pact, if necessary, by restriction or removal from the  market
       for some or all uses.  This includes research input into risk
       assessment, particularly for health and ecology risks.

    •  Initiate enforcement actions, using both EPA  headquarters and
       regional office resources, in emergency situations involving sub-
       stantial threats to public health or safety.   Provide transfer
       of information from research data base on exposure assessment
       and effects assessment to headquarters and regions in a useable
       form to support these actions.

    •  Audit laboratories to assure data validity.   Provide basic quality
       control tools and update analytical chemical  methods for OPP con-
       tract laboratories.

    •  Establish,  support, and strengthen Federal-State cooperation in
       the enforcement of FIFRA.

    •  Enforce Federal certification of applicators, monitor and up-
       grade State applicator certification programs, and continue
       Federal certification in Colorado and Nebraska and for  Federal
       agencies.  Develop certification, training, and enforcement
       programs with the Indian Nations.

    •  Incorporate IPM strategies into special regulatory actions (e.g.,
       section 18  emergency exemptions, and RPARs) when technically
       appropriate.   Regional offices collect and provide information
                                                                   0173

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            on 0PM techniques to headquarters for use in special registrations
            and RPAR reviews and to State applicator training programs.  Co-
            operate with USDA and other agencies in carrying out research to
            develop a data base on effectiveness of IPM.

     III. FISCAL YEAR 1980 PROGRAM HIGHLIGHTS

        The proposed Fiscal Year 1980 program provides for an increase in the
     production of registration standards in order to complete the reregistra-
     tion, in roughly a decade, of approximately 40,000 pesticides.  Most of
     these products have never been scrutinized for chronic, low-level, long-
     term effects.  The RPAR process will be completed on the majority of the
     65 chemicals originally listed as RPAR candidates.  Programs will be re-
     oriented to merge the RPAR process with standards development by 1981.
     High levels of quality and timeliness on special registrations will be
     maintained and process improvements made to keep close check on all head-
     quarters, regional, and State section 5(f),  18,  and 24(c)  actions.
     Registration and tolerance activities will be increased to deal with an
     increased quantity of registrations granted, for the most part on a
     conditional basis, presuming the new legislative amendments are enacted.
     Headquarters and regional certification and training activities will
     center  on recertification of private and commercial applicators, the
     development of Indian Nation plans, and amendments to State plans.

        With emphasis on the State role in the pesticides enforcement pro-
     gram through the grant mechanism, the Federal role will continue to
     shift from traditional Federal inspection activities to grant management
     and oversight, import surveillance, Federal enforcement, of Federal certi-
     fication of applicators where States do not have an applicator certifi-
     cation  program, investigations and follow-up enforcement related to
     laboratory data audits, and section 18 monitoring.

        The Fiscal Year 1980 research and development program calls for
     modest  increases in health and ecological efforts.  A new effort will
     provide exposure models and testing protocols based upon transport and
     transformation characteristics.  Ecological effects research will aim at
     increasing the number of compounds under study and development and valida-
     tion of test protocols.  The IPM program will remain an extramural effort
     centering on development of methods and approaches to pest control which
     reduce  adverse environmental effects and costs from traditional methods
     of pest control.  Quality assurance has been increased to assist in
     development of reference materials and performance evaluation samples.
    IV. REQUEST SUMMARY
                                  FY 1980 Total     Changes from FY 1979
                                  PFT   BA ($000)   PFT       BA ($000)
    Abatement and Control	 788   40,131.2    +61       -2,420.5

         Registration Standards,.. J.97   12,452.3    +36       +1,132.0

0174

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    This increase will be used to accelerate completion of the non-
prototype generic standards that were initiated in Fiscal Year 1979»and
to cement the standards production and maintenance process as a workable
regulatory means of reregistering pesticides.  Because the production
phase of a standard extends beyond a 12 month period, the first standards
will be completed in 1980 after prior year initiation.  The resources
will also be used to prepare a plan for integration of RPAR into the
registration standards process in anticipation of a process merger by
Fiscal Year 1981.

    RPAR Chemical Reviews	161   12,246.6    -24      -2,870.8
    Headquarters	156   12,108.7    -17      -2,690.8

    This decrease in resources for rebuttable presumptions reflects the
reduction of program activity as work is completed on the initial two
lists of chemicals first accepted as RPAR candidates.  The completion
of work on the bulk of these initial 65 chemical classes will provide
experience for merging the RPAR program with registration standards by
1981.  Similarities between the RPAR and registration standards processes
illustrate the cost-effectiveness of combining future RPAR investigations
with standards production; this decrease in RPAR resources is paired with
an increase in registration standards resources in preparation for a
merger of these processes.

    Regions	5      137.9    - 7        -180.0

    This decrease reflects the diminished priority of Regional partici-
pation in the RPAR process as compared to special registration and
pesticide use management activities.  The Fiscal Year 1980 headquarters
RPAR process will be completing those review phases for which the regions
supply comments on position documents, assessment team reports, benefits
information, and specialized area information.  Hence the Regional RPAR
role will diminish.

    Special Registration	82    2,030.5    +11         +47.1
    Headquarters	66    1,621.2    +2

    The additional positions will provide the process checking measures
required to maintain a responsive program.  Receipt of all section 18
emergency exemptions will be acknowledged, all section 5 experimental
use permits and section 18 final reports will be filed, additional re-
vised labels will be reviewed for agreement with the terms of each
special registration, and a sampling program will be established to
evaluate the scientific validity and legal adequacy of data submissions.

    Regions	16      409.3    +9         +47.1

    These resources will improve regional ability to review section 18
emergency exemption requests, section 5 experimental use permits, section
24(c) special local needs registrations and temporary tolerance petitions,
and better insure that the terms accompanying the applications (e.g.,
acreage and time limitations) are correct before transmittal of the
                                                                      0175

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requests to headquarters.  Some decentralization of special registration
activity will also be possible from OPP to the regions, especially where
particular area knowledge is important to the Agency's decisions.  The
24(c) special local needs registration program is a likely candidate for
such transfer, depending upon the outcome of pilot regional efforts in
Fiscal Year 1979.

    Registration	244   8,249.4     +17       -221.2

    Because of the legislative changes expected to be enacted by the
beginning of Fiscal Year 1979 that will permit conditional registrations
and free strictures in the registration process, an increase is expected
in regulatory decision-making in 1980 on applications for administrative
and technical amendments, new chemical registrations, and routine re-
gistrations.  The submission of such applications, which have been stymied
until the new legislative changes are made, will suddenly increase in
1979 and require additional positions.  A reduction in funds is antici-
pated when 1979 contracts for conditional registration startup are
terminated.

    Tolerances	57   1,319.6     + 6

    This increase in positions is due to the expected increase in demands
for conditional registrations and a concomitant increase in tolerance
petitions.

    Pesticides Use Management..47   3,832.8     +15       -507.6
    Headquarters	16   2,609.3      -        -521.9

    Applicator certification and training and restricted use pesticide
activities will continue at 1979 levels.  Legal and funding assistance
will be provided to regions for State and Federal certification programs,
and development of Indian certification plans will continue.  IPM will
continue to be incorporated into regulatory processes and some instruc-
tional material disseminated in accordance with section 4(c) of FIFRA.

    Regions	31   1,223.5     +15        +14.3

    This increase will permit the regions to provide a higher level of
service—as is required of a national pesticide program.  It will enable
Regional Offices to provide assistance to registrants and small formu-
lators who cannot afford to send representatives directly to headquarters
as can large corporations.  It will also improve State and Federal agency
certification programs and support Federal programs in Nebraska and
Colorado.

                              FY 1980 Total     Changes from 1979
                              PFT   BA ($000)   PFT      BA ($000)

Enforcement	118   13,058.7    -28         +7.4

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    Pesticides Enforcement/	18   10,102.2    -6       +543.0
      Grants

    Fiscal Year 1980 activities include a continued decrease in tradi-
tional Federal inspectional activities offset by an increase in Federal/
State cooperative enforcement grants, and investigations and enforcement
related to laboratory data audits.

    Pesticides Enforcement	100   2,956.5     -22       -535.6
    Regions	 72   1,875.5     -13       -281.9
    Headquarters	 28   1,081.0     -9       -253.7

    Fiscal Year 1980 activities include a continued decrease in tradi-
tional Federal inspection activities, offset by increased State over-
view and grant management responsibilities.  Other Fiscal Year 1980
regional activities include import surveillance, Federal enforcement
of Federal certification of applicators, and enforcement support of
laboratory data audits.

                              FY 1980 Total     Changes from FY 1979
                              PFT   BA ($000)   PFT      BA ($000)

Research and Development	152   11,293.0    +20      +1,394.8

    Health Effects	 79    6,312.0    +7        +573.8

    Protocol research and development activities will be expanded in the
area of human exposure determination.  Capability for toxicological
testing of an increased number of pesticides will also be provided.

    Ecological Effects	57   2,816.0     +5        +256.0

    Using representative generic, RPAR, and other pesticide compounds,
protocol development and validation will be hastened.  Additional numbers
of compounds will be examined.

    Pesticides Management	-    1,200.0

    The 1980 funding level for Pesticides Management is the same level
as for 1979.  The major program change involves increased research on
totally integrated insect and weed  control systems, including in-
creased technology transfer.

    Quality Assurance	9     440.0     +1         +40.0

    A new program will be initiated to develop special quality control
reference materials and performance evaluation samples and tools for
biological testing laboratories.  These new tools will allow quantiative
comparisons to be made of the analytical performance of biological
testing laboratories.

                                                                    0177

-------
        Transport,  Fate  and	7      525.0    + 7        +525.0
          Exposure  including
          characterization and
          measurement methods
          development

        During  1980, these resources will be used to (1) provide scientific
    assistance  to The Office of Pesticide Programs,  (2) develop exposure
    assessment  models for pesticides in food chains, other media, and
    humans,  (3)  perform  transport and fate research on selected pesticides
    in aquatic,  air, marine, and terrestrial environments, (4) develop testing
    protocols for pesticides, and (5) carry out exposure analyses of selected
    pesticides.
0170

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-------
                     ENVIRONMENTAL PROTECTION AGENCY

  RM 1:  DECISION UNIT OVERVIEW
 A) DECISION UNIT TITLE (AND CODE)                     HQ  QED     MEDIA?esticides

  Pesticides:  Health Effects (E1C5) '	REG-	APPRO: R & p
  B)  LONG RANGE GOALS AED MAJOR OBJECTIVES

  This decision unit provides research information and technical assistance in
  support of agency activities under the legal requirements of Federal Insecti-
  cide, Fungicide, and Rodenticide Act (FJFRA).  The program objectives are to:

  1.  Determine health effects of major classes of pesticides now registered
      by EPA.
  2.  Evaluate the safety of new and substitute pest control agents, such as
      viruses.
  3.  Develop and validate new toxicological methods to be used in pesticide
      registration.
  4.  Develop and apply analytical methods for detecting pest control agents
      which may affect humans.
  5.  Support the Rebuttable Presumption Against Registration (RPAR) of pesticides
      process with scientific data base information.
  6.  Develop integrated pest management (IPM) systems to reduce reliance on
      'the use of chemical pesticides.
  7.  Determine the level of exposure to pesticides by persons either occupation-
      ally or environmentally exposed.

  C)  FY 78 ACCOMPLISHMENTS

  1.   Initiated field studies to determine safe reentry times for aaitraz  (BAAM),
      zolone, and encapsulated methyl parathion to better define pesticide
      safety for pesticide and agricultural workers.
  2.   Completed evaluation of lightweight protective clothing against parathion
      for pesticide applicators.
  3.   Continued method development studies for determination of low levels of
      toxaphene and metabolites in adipose tissue to facilitate evaluation of
      their presence and health consequences in the human.
  4.   The delayed neurotonic effects of EPN, DEF, and merphos were determined.
  5.   The effects of carbaryl and 2,4,5-T on the developmental patterns and
      profiles of the isozymes of lactate dehydrogenase (LDH) and creatinine
      phosphokinase (CPK) in maternal and neonatal tissues were determined.
  6.   Investigated the cocarcinogenic activities of selected pesticides by
      in vivo and in vitro methods.
  7.   Studied effect of route of administration, dose, time bioisomerization and
      pesticide pretreatment on in vivo and in vitro metabolism of lindane.
  8.   Investigated the structural region of the molecule responsible for the
      insecticidal and carcinogenic activities of dieldrin.
  9.   Studied the ability of 5 pesticides to mutate corn as a screen for potential
      mutagenic effects in the human.
  10.  Tested 20 pesticides for gene mutation and D1TA damage in bacteria and
      yeast as validation of information to be applied to registration of pesti-
      cides under FIFRA.
  11.  Initiated an investigation on gas chromatographic capillary systems applied
      to multiresidue analysis for pesticides.
  12.  The comparative placental transfer of carbaryl in the mouse, rat, and
BO* c.^. 7H0.1Q (3-73)

-------
 FORM 1:  DECISION UNIT CVEnViEV.'
  A,  2EC!SICN UNIT 7!T'.s AND CCCŁ;                      HC ORD       V.Ł3!A Pesticides!
                                                                                    I

 Pesticides;  Health Effects (E105^	       ***•	A.=Q=iC-R & D     i
     hamster was determined using radio-labelled compounds to facilitate
     extrapolation to man.
 13. The hazardous effects of ethylene oxide were determined by the inhalation
     route to verify its safety as a fumigant.
 14. Studied the role of free radical pesticide metabolite intermediates,  and
     the effect of pretreatment with 3 classes  of enzyme inducers  on a short-
     term model substrate assay and identified  3 new metabolites of the sub-
     strate in order to better understand what  hazardous effects develop
     within the human after exposure occurs.
 15. The hazardous effects of pesticides of  the formamidine group  and the  role
     of glutathione transferase enzymes in pesticide metabolism were studied.
     These agents inhibit the activities of  the enzymes, prostaglandin
     synthetase and arylglutathione transferase.
 16. The biphenyl hydroxylase enhancement assay was  implemented and evaluated
     against a series of 10 pesticides and a set of  known carcinogens and
     non-carcinogens.
 17. The mouse lymphoma mammalian cell mutation test system was implemented  as
     a. test in the battery of procedures for determination of mutagenicity
     and prediction of carcinogenicity of compounds.

 D)  FY 79 PROGRAM DESCRIPTION

,1.   Populations exposed to priority pesticides during  garden  and  home use  will
I      be selected and evaluated.   Studies will  be conducted  relating  to field
      worker exposures and to population exposure hazards  from use  of pesticides.
 2.   Develop methods to measure  toxaphene and  its metabolites  in the urine.
 3.   Evaluate  collection media and devices  for determining  PCB's, PCN's and
      other pesticides in air.
 4.   Evaluate  the reproductive and other subchronic effects of dinoseb, dibrom
      bidrin, and cacodylic acid.                                               '
5.   Study the toxic effects of  ethylene dibromide  by inhalation.
 6.   Evaluate  the neurobehavioral effects of high priority  pesticides in rats.
7.   The effect of the phenotypic differences  in inbred mice on the metabolism
      of lindane and  benzo(a)pyrene.
8.   Study the role  of dechlorinase and  glutathione transferases in the metabo-
      lism of pesticides.
9.   Identify  the sites of  binding to DNA, and perform unscheduled DKA synthesis
     and mammalian cell mutagenesis bioassays of dieldrin analogs.
10.  The mouse lymphoma L5178Y mammalian cell mutation system will be further
i     developed to  detect both chromosomal aberration and gene mutation endpoints.
11.  The presumptive promotional activities of pesticides will be  investigated
I     using an  oucogenic transformation-two-stage carcinogenesis bioassay.
p.2.  The ornithine decarboxylase assay will be implemented and evaluated as a
i     bioindicator for  tumor promoters using a selected number of pesticides
j     and toxic  chemicals.

FT 79 ALTERNATIVES:  A major alternative for this program was considered to
be a completely extramural approach, eliminating intramural capabilities and
maintaining scientific  staff to monitor the program.  This alternative was
rejected as an undesirable option because of: (1) increased cost,  (2) lack of

i     uiev

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                     ENVIRONMENTAL PROTECTION AGENCY

  RM1: DECISION UNIT OVERVIEW  ,
 Ai  DECISION UNIT TITLE ;AND CCCE)                     HQORD        MEDIA: Pesticides
                                                                                 I
 Pesticides:   Health Effects (E105)	RŁG-	APPRO: R & p     I
                                                                       Jll 'J
EPA regulation-specific expertise in extramural  laboratories,  (3)  inability       j
to fulfill regulatory needs for expert  advice and  testimony  in legal actions.
The intramural personnel are knowledgeable and responsive  to EPA program
requests and this knowledge of regulatory needs  is crucial.  This  team of
scientists work well together and know  and appreciate regulatory demands.

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                  ENVIRONMENTAL PROTECTION  AGENCY
FORM  a: DECISION  UNIT LEVEL ANALYSIS
A,  DECISION  UNIT  TITLE AND  CODE          HQ        MEDIAi  PEST
E105  HEALTH  EFFECTS-PEST                           APPRO:  R  & D
B, RESOURCE SUMMARY
POSITIONS PFT
LEVEL OPFT
01 OF 05 PTE
BUDGET AUTH. (000.0)
FY 76 ACT
71.0
9.0

5,000.0
FY 79



5,
C. E. FY «
7Z.O
9.0
8U.8
738.2 t
^0 INCR
54, 0
7.0
73.0
*, 303.0
FY 80 CUM
5«.0
7.0
73.0
flf 303.0
 C. DESCRIBE THE INCREMENTAL ACTIVITIES Cr THIS LEVEL ONLY. DESCRIBE THE BENEFITS
    OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.


Activities:
   Evaluate the biological effects of commonly-used pesticides  in laboratory
   animal systems  and  in cell cultures.  At this level the response vould be
   sub-optimal for program needs.  Specific studies will include acute oral
   and dermal LDcn and respiratory LE__ values, sub-acute and chronic  toxic-
   ity, teratology, pathology, behavioral effects, neurotoxicity mutagenesis,
   and carcinogenesis.   (R10-15/15)


   Develop and validate analytical chemical methods for pesticides and pesti-
   cide metabolites in human and animal tissues, excreta, air,  and other
   environmental media.  Analytical methods needed in exposure  measurement
   procedures will be  given priority.  (E10-1/15)

   Determination of the level of exposure to pesticides by persons either
   occupationally  or environmentally exposed.  Both direct and  indirect
   methods of human exposure measurement will be developed and  used.   In
   addition to obtaining exposure data on compounds specified by OPP to be
   of priority need, emphasis will be given to development of standard pro-
   tocols for exposure determination for routine use as a registration re-
   quirement.  The possibility will be explored of using representative
   compounds for extrapolating direct applicator exposure data  to other
   similar compounds.

   Assess the hazardous effects of those substitute pesticides  (SCT) which are
   under consideration by OFP to replace compounds which are banned.

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                      ENVIRONMENTAL PROTECTION AGENCY

FORM 2:  DECISION UNIT LEVEL ANALYSIS

  A.  DECISION UNIT TITLE ,A\D CODE)                     HQ 0RD     MEDIA.pesticides

   Pesticides:  Health Effects  (E105)                 REG.         APPRO-R &  C
  5.  RESOURCE SU.VVARY          FY 73 ACTUAL  FY 79 C. EST    FY 30 INCH    FY SO CUV.
              I SQSIT'ONS
     LEVEL    i
    1 _   5  I	FTT
     •OF-
              (BUDGET AU~H .ceo c;t            i
  C.  DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY.  DESCRIBE THE BENEFITS
     OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.


 Impact;   Consequences of not funding are:

    M-tnimal responses to regulatory needs.

    Analytical  chemistry support would  be at a sub-optimal level.

    Loss of technical support including expert testimony and scientific
    review for  OPP  and other program offices.

    Would  constrict our ability to maintain an existing international
    scientific  expertise on pesticides.

    Reduce likelihood that suitable pest  control methods will be available
    as  substitutes  for pesticides which may be cancelled.

    Only a limited  amount of data from measurement and evaluations of the
    hazardous effects of pesticides would be available.

    Health effects  research relative to the use of IFM systems would not
    be  available  for biological agents, viruses, etc.  Health effects
    research on problems related to other organisms, protozoa, bacteria,
    fungi, etc. would not be considered.

    Research information on the human health effects of pesticides, provided
    through this  decision unit, is of considerable importance to future
    enforcement and regulatory activities of OFP.  Testing methods and data
    relating to the hazardous health effects of pesticides are essential to
    the safety  determination of chemicals prior to registration for market-
    ing and use.

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                   ENVIRONMENTAL PROTECTION  AGENCY

•'FORM  2:  DECISION UNIT LEVEL  ANALYSIS
A, DECISION UNIT TITLE /
E105 HEALTH EFFECTS-PEST
'B, RESOURCE SUMMARY
POSITIONS PFT
LEVEL OPFT
02 OF 05 FTE
BUDGET AUTH. (000. 0)
NO CODE

FY 78
7


5,00


AC
1.
9.

0.


T
0
0

0
HQ

FY 79



5,


C. E.
72.0
9.0
8U.6
738.2
MEDIA
APPRO
FY P




1
J
0




PES
R &
INC
10.
2.
7,
861.
T
0
R
0
0
3
0


FY 80 C
64
9
80
5,16«


UK
.0
• o
.8
.0
  C. DESCRIBE THE INCREMENTAL ACTIVITIES CF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
    OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.
 Activities;

 o  Develop predictive mathematical models which can be used to assess human
    dose/response effects from exposure to selected pesticides.  Pharmacokinetic
    studies will be carried out to serve as guide to model development.

 o  Refine animal and  cell culture models for assessing the mode of actions
    of pesticides which  are potentially carcinogenic in humans.

 o  The potential carcinogenicity of pesticides under investigation will be
    evaluated using the  appropriate and accepted battery of ^n vivo and in
    vitro short-term screening and validation tests.  (R10-1/15), (R5-23731)

 Impact;

    Assessment of exposure to pesticides by humans would be carried out at
    a minimal level; thus important data on effects of priority pesticides
    would not be available for FIFRA decisions.

    The quantity and comprehensiveness of hazardous effects data, affecting
    both the  number of compounds studied and the timeliness of research input
    to FIFRA  decisions would be reduced such that an insufficient scientific
    data base would exist.

    Insufficient technical assistance would be provided for validation and
    review to meet the needs of OFP in reregistration and RPAR decisions.

    Rapid-response capability to provide toxicological and chemical
    analyses  would be  insufficient to meet GPP needs.

    Decisions and recommendations for evaluating substitutes for RPAR
    candidates would be  made using a limited data base.
         Olbl

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f
                  ENVIRONMENTAL  PROTECTION AGENCY

      35  DECISION UNIT  LEVEL  ANALYSIS
 . DECISION  UNIT TITLE  AND CODE         HQ       MEDIAj  PEST
Eios  HEALTH  EFFECTS-PEST                          APPROI  R & D

B, RESOURCE  SUMMARY       FY  78 ACT  FY 79 c.  E.   FY  eo  INC"    FY so  CUM
         POSITIONS  PFT          7i,o         72.0           e,o         72.0
 LEVEL              OPFT           Q.O           o.o                         9,0
03 OF  05            FTE                       B4.e           a.o         &U,B
   BUDGET AUTH.  (000.0)     5*000.0      5,738.2         57a.O      5,738.0
   C.  DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL CNLY.  DESCRIBE THE BENEFITS
      Or FUNDING AND THE CONSEQUENCES OF NOT FUNDING.
  Activities:
  o  Health implications of "new generation" biological pest control agents
     will be investigated.  Initial emphasis will be given to study of insect
     viruses.  Goal will be development of adequate  test methods for routine
     use for evaluation of potential human health hazard of these agents.
     (R8-11/13)

  o  Increase the number of tests used and the related validations for study of
     potential carcinogenicity of pesticides and  particularly the relationship
     between cutagenesis and carcinogenesis to strengthen related assessments.
     Use of this relationship in development of short-term screening test
     methods will be fully explored.
  o  Increase the scope of analytical chemical methods development by involving
     more pesticides in a broader variety of human tissues and environmental
     media in relation to human health effects studies.

  Impact;   Loss of funding would result in:
     Crucial research and important exposure data not being available for
     the use of FIFRA decision makers at the necessary time.

     Limited health effects research in the "new generation" area which
     would seriously impede progress toward the objective of providing
     alternative methods of pest control.

     Inadequate development of protocols for mutagenesis/carcinogenesis
     bioassay to support regulatory guidelines.

     Data from important research areas in  health effects program (i.e.,
     immunology, biomagnification) would not be available for consideration
     by regulatory programs.

     Minimal validation of submitted industry EPAP. data.
                                                                       D1S2

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                  ENVIRONMENTAL  PROTECTION AGENCY

FORM  
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-------
                     ENVIRONMENTAL PROTECTION AGENCY
FORM!:  DECISION UNIT OVERVIEW
A) DECISION UNIT TITLE (AND CODE)
Pesticides Ecological Effects (E110)
HQORD
REG.
MEDIA: Pesticide
APPRO: R&1)
  B)  LONG RANGE GOALS  & MAJOR OBJECTIVES

     The long range goal is  to determine cumulative  ecological  impacts  of  acute
  and chronic effects  of pesticides,  singly and  in combination, on  target  and
  non-target  organisms in terrestrial and aquatic ecosystems.

  Major objeetives  to  support this  goal are:

  1.  Development of sensitive bioassay measurements  and  techniques  to measure
     pesticide effects in organisms.

  2.  Development of laboratory,  field,  greenhouse, and microcosm techniques
     to assess pesticide-organism responses and  subsequent  ecological inter-
     actions  within an aquatic or terrestrial  ecosystem.

  3.  Provision of accurate data on  ecological  and biological effects of specific
     Generic  and those pesticides involved in  rebutable  presumption (RPAR) and
     non-RPAR compounds for  agency  regulatory  purposes.

  4.  Determination  of  pesticide transport and  fate within ecosystems and relate
     this information  to hazard assessments for  regulatory  purposes.

  FY  78 ACCOMPLISHMENTS
         •                                                               *
  1.  Developed..Mobile" bioassay techniques for  on-site  evaluation  of pesticide
     industrial  plant  discharges.

  2.  Developed new  rapid screening  techniques  for determining exposure
     assessments of pesticides entering aquatic  and  terrestrial environments.

 -3.  Conducted emergency research on  effects of  Kepone on the James River and
     Chesapeake  Bay organisms  and environment.

  4.  Provided expert technical testimony for the Agency's various judicial
     proceedings concerning  pesticides  such as endrin, chlordane, and kepone.

  FY  79 PROGRAM  DESCRIPTION

      The program consists of:

  1.  Continued development of  acute,  chronic,  bioaccumulation, community,
     behavioral,  and microbial effects  methodologies.
      k

  2.  Continued development of  community effects  and  entire  life-cycle effects
     methods.

  3.  Continued development of  microcosm techniques to measure pesticide  effects.
 EPA Form-2410.10 (8-78)

-------
                    ENVIRONMENTAL PROTECTION AGENCY
DRM 1:  DECISION UNIT OVERVIEW
     ECISION UNIT TITLE (AND CODE)
    icides Ecological Effects (El10)
HQ  ORD
REG.
MEDIA; pesticide
                                                                APPRO:
                                                                          R&D
4. Participation in evaluation of RPAR data and compounds.

5. Continued development of testing protocols.

5. Continuation of a small effort to develop transport and fate methods.

7. Initiation of a small effort on development of hazard assessment models.
 A Form. 2410.10 (6*78)

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                  ENVIRONMENTAL PROTECTION  AGENCY

FORK  2! DECISION UNIT  LEVEL  ANALYSIS
""••"""•"••"• — •••"•••"••"••••••"•"•••••••••••••••••••••••••.»«»»» — mmvmm
A, DECISION UNIT TITLE AND CODE         HQ       *EDJAi PŁST
EllO  ECOLOGICAL EFFECTS-PEST                      APPRDi R &  D

8. RESOURCE SUMMARY       FY  78 ACT  FY 79  C.  E.  FY  PQ INC*  ""py'so
         POSITIONS  PF7         52.0         53.0         J9.0          39.0
 LEVFL              OPFT          7.0           6.0          6.0           6.0
01 OF  06            FTE                      63. «         5^,1          5*1.1
   BUDGET AUTh. (000.0)     2,300.0      2,560.0      1,920.0       1,920.0
  C.  DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
     OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.

  Activities                          •                                '

    . A minimum  program to develop protocol for assessing  hazards to non-target
      fish and wildlife of applications of pesticides on farmlands, forests,
      lawns,  and other sites. Develop in such a way to insure  that protocol
      can be  transformed to data requirements for industry.  Integrate with
      protocol developed for toxics and other chemicals. At  this level, acute
      and limited chronic test developed.

    . Limited testing of Generic and RPAR pesticides and suggested RPAR
      alternates (representing families of pesticides) to  determine "no
      effect" levels on indicator plants and animals only. Pesticides selected
      through cooperation with OFF and RPAR process by identifying and assessing
      available  literature, gaps in data base, and conducting  research *
      to  fill gaps.

    . A tn-Hm  program to develop protocol to determine transport, fate, and
      transformation related to exposure assessments in the  terrestrial,
      freshwater, and marine environments.

    . Provide necessary analytical services to support effects and residue
      studies.

   Impacts

    - Funding at this level will provide for a m-fTi-tmnn program to determine
      environmental impact of pesticides.  Few compounds of interest to RPAR
      will be studied in terms of data assessments and experimental work.
      Involvement in RPAR process minimal. Technical assistance  to Regions
      will be provided only on a crisis basis, both in terms of  conducting
      quick ecological effects tests and in acting as expert witnesses in
      litigations.

      At  this funding level it will be impossible to maintain  state-of-the-art
      capability in the area of pesticide impact assessment  on the environment.

      At  this funding, little effort will be possible to develop hazard
      assessment models synthesizing effects data with transport and fate data.

      Not funding this level would eliminate the Agency expertise in pesticide
     Environmental effects research and assessment. The Agency  would then have
      to  depend  on small programs at contract labs and on  industry for its
      data assessment and production.	

-------
                  ENVIRONMENTAL PROTECTION  AGENCY

FORM 2s DECISION UNIT LEVEL  ANALYSIS
A,  DECISION  UNIT  TITLE AND  CODE         HO       MEPIAj  PEST
Eno ECOLOGICAL EFFECTS-PEST                     APPRO*  RID
w******'"**'*'**w — *******">**B***w*n"****ww»**ww»w(Bi»^»^i»*w^***fl»*fp^»w
-------
                                  PROTECTION  AGENCY

FOR"  2{  DECISION L'N'IT  LEVEL ANALYSIS
 * ** ™* * *  ™ ™ ** " ••••••^•••••••^^••••W •• • W V WwWWVtMVlfllW •* • • •• •••'•^•'^•••l^ gp V • * •> •§ Mi •* * "* •* • • W W W
A, DECISION UNIT TITLE  AMD CODE          HO      HEPTA| PEST
Eiio  ECOLOGICAL  EFFECTS-PEST                     APPRPI R & o
 ™ ^ ^ ^  ^ ^ ^ ^ ^ ^ • H W V W OT M ^ •! ^ ^ • ^ V 41 M » W •§ ^ • flp •• V 4P W W 1^ • IW • V •> • • IP V W • gp ^ d V ^ * V V • V V • M • W • • •
B. RESOURCE SUMMARY       FY 78 ACT FY 79  C. E,  FY »0 JNCR   FY 80 CUM
         POSITIONS  PFT          52.0         52.0          «,0         56.0
 LEVEL              OPFT          7.0          8.0          1.0          9,0
0« OF  Ob            FTE                       63.a          5.4         6S.8
   BUDGET AUTH,  (000.0)     2,300.0      2,560.0        20«.8     2,76^.6
   C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
     OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.

   Activities
   ••••••^••^•^•••••••••w        •     •

    . Increase the number of Generic, RPAR and alternate pesticides  for
     "no-effect" level testing.

    . Study mechanisms of effect  for  hazard assessment purposes.

    . Increase effort to integrate ecological and fate and transport hazard
     assessments

   Impact

    . This will provide resources to  permit laboratory personnel  to  perform
     critical data assessment and provide laboratory information to OPP for
     Generic .and RPAR processes  to meet their legislative mandate.
EPA Form 2410-11 (8-78)

-------
                 ENVIRONMENTAL  PROTECTION  AGENCY

      ^'.  DECISION  UNIT LEVEL  ANALYSIS
A. DECISION UNIT  TITLE AND CODE         HE       MEDI A |  PEST
E110 ECOLOGICAL EFFECTS-PEST                     APPROi  R & 0
        **"•"•* 9f • W W • • W • • w W V V • W • • qp IB • M • W ^ 9 flV 4V iV *•• Vk • • 4V Ml W • •> ^P W • V W Vp ff9f • ^ •) V V • W W V W VP V
B. RESOURCE SUMMARY       FV ?s ACT FY 79 c.  E.  FY  eo  INCK   FY so cu*
         POSITIONS  PFT        52.0        52.0          i.o         57.0
 IEVEL             OPFT         7.0          8.0          1.0         10,0
05 OF  Oo            FTE                     63. a          2.5         71.3
   BUDGET  AUTH. (000.0)    2,300.0     2,560.0         51.2     2,*16.0
  C.  DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
     OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.

   Activities

       . Increase effort to Integrate ecological and  fate and transport
         hazard  assessments.
   Impacts
         ORD laboratory personnel could better relate  effects and transport
         data to provide OPP with additional information in their criteria
         documents.
       U213
EPA Form 2410-11 (8-78)

-------
















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-------
                     ENVIRONMENTAL PROTECTION'AGENCY
FORM 1:  DECISION UNIT OVERVIEW
  A)  DECISION UNIT TITLE (AND CODE)
 PESTICIDES/Pesticide Management (Industrial)
  (E120)
KQ  ORD

REG.
MEDIA: Pesticide

APPRO:
  B)  LONG RANGE GOALS & MAJOR OBJECTIVES
Goal:        The development of biologically integrated alternatives (i.e. inte-
             grated pest management (IPM)) for use with chemical pesticides to
             control agricultural and urban pests, primarily insects and weeds.
             IPM strategies designed to effectively utilize 'alternative bio-
             logical controls are a necessary part of the Agency's pesticide
             regulatory strategy.

Objectives:  (1) Develop integrated pest mangement (IPM) systems (insects and
             weeds) for cotton, soybean, alfalfa, apple, pine and corn-eco-
             systems,  (2) Develop IPM systems for urban pests, including cock-
             roaches, fire ants, aphids in shade trees, turf pests, termites,
             mosquitoes, and similar pests,(3) Conduct technology transfer
  C>  FY78ACCOM^L7siHMiNTl°r n6W IPM systems» Deluding control strategies.

1.   Final reports covering the six year "Huffaker" study will describe IPM
strategies for six crop ecosystems studied:  cotton, alfalfa, citrus, soybean,
stone and pome fruits and pine forests.
2.   Final report describing an IPM system for control of cockroaches in urban
areas.
3.   Revised multi-agency, multi-disciplinary insect-weed IPM research program
proposal for cotton, soybean, alfalfa and apple crop ecosystems (Adkisson pro-
ject).
     Final report on utilization of pest ecosystem models for prediction and
control of pest populations utilizing IPM control programs.
  D)  FY 79 PROGRAM DESCRIPTION
The FY 79 program will continue the development of multi-agency, multi-discipli-
nary IPM research for corn, cotton, soybean, alfalfa and apple crop ecosystems.
 tfork will continue on the development of alternative biological controls for
urban pests.  Technology transfer efforts will be accelerated to assure that the
latest IPM technology is transferred to the agricultural and urban communities.
EPA's research supports production of basic biological knowledge on insects and
weeds to determine weak links in the pest life cycle which can be utilized in
IPM control strategies.

Alternative methods for implementing EPA's IPM program which have been considere
and rejected include:  (1) total EPA inhouse program is not feasible because of
the lack of staff and laboratory facilities unique to IPM research,  (2) utili-
zation of USDA's  inhouse capability is also not feasible because USDA lacks the
research and regulatory mandate under FIFRA and their emphasis is on food and
 Fiber production.  On the other hand, EPA's current totally extramural approach
utilizes top researchers in key Land Grant universities across the Nation.
Applicable results are immediately available to the state agricultural user
community.  The EPA program therefore is cost-effective and places research
results quickly and effectively into farm operations.
      U2L7
EPA Form 2410-10 (8-78)

-------
                   ENVIRONMENTAL  PROTECTION  AGENCY

      2! DECISION  UNIT LEVEL ANALYSIS
 , DECISION  UNIT  TITLE  AND CODE         HO
 '120  INTEGRATED PESTICIDE MGTCINDUSTRIAD
                                J  PEST
                          APPRO I  R  & D
B, RESOURCE  SUMMARY
         POSITIONS   PFT
 LEVEL              OPPT
01 OF  ic-             FTE
   BUDGET  AUTH,  (000.0)
FY  78  ACT  FY 79  C.  E.   FY 80  INCR    FY 80  CUM
     800,0
1,200.0
900.0
900.0
  C.  DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
     OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.
 ACTIVITIES
 This  Base  Level  implements a continuation in program priorities, relying on
 extramural grants to conduct the IPM studies on major crop, urban, and other
 selected ecosystems.                   .. .

    Continue research on soil arthropods in the corn ecosystem.  Emphasis will
    be on non-chemical control of black and bronze cutworm, white grub, and
    wireworm.  The development of field techniques (e.g., baiting and soil
    sampling)  for locating insects, of models of population dynamics, and of
    the costs  of  control measures will be carried out.
    Continue multi-state research on biological control of insects and weeds in
    the cotton, soybean, alfalfa, and apple ecosystems.  Included will be field
    application of present data base, greater emphasis on system economics, and
    new efforts on weed control along with previously developed insect control
    techniques.
    Continue two-state research program on insect and disease control of musk
    thistle.   Also work will be done on life-cycle studies to determine its
    competitive mode of spreading.
    Develop pathogenic control of selected weed species.  Study factors re-
    sponsible  for infection and spread of viral, bacterial, and fungal dis-
    eases of one  or two major weed species.
    Develop urban pest management techniques to control turf pests in lawns
    utilizing  pathogenic and prey/predator control technology.
    Continue development of field dispersion techniques for sex pheromones to
    disrupt mating of the three-banded leaf roller in the apple ecosystem.
    While small-scale tests have proven successful, the application of this
    research to larger areas needs additional development to permit effective
    control.
    Continue grant on application of ecosystem model as a control system.
    Techniques will be developed in a field study in a small, controlled area,
    with a  mono-crop ecosystem.  This will be a fully integrated, biological/
    land use/economic study emphasizing reduced chemical pesticide usage.

 IMPACT
    The management of pest populations is  a dynamic process  that requires
    continued adaptation in technology as  pests  adapt and change.  IPM research
    also requires the commitment of multi-year studies;  thus the bulk of this
    level's activities are continuations of previously initiated studies.
    Not funding this Base Level terminates all IPM studies;  considerable data
    from partially completed studies would be lost.
    Anything less than this level will not be supportive of  requirements of J2L j
    FIFRA and the Office of Pesticide Program (OPP) needs.      	
 EPA Form 2410-11 (8*78)

-------
                  ENVIRONMENTAL PROTECTION
FORM  2; DECISION UNIT  LEVEL  ANALYSIS
A. DECISION  UNIT TITLE AND  CODE"         HQ
Ei?0  INTEGRATED PESTICIDE ^GT(INDUSTRIAL )
                                 PEST
                         APPRUi  R & D
B. RESOURCE  SUMMARY
         POSITIONS  PFT
 LEVEL              OPFT
02 OF  10            FTE
           AUTH.  (000.05
FY 78  ACT FY  79 C. E.   FY HO  INCR    FY 80  CUM
    800,0
1,200.0
180.0
1,080,0
  C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY.  DESCRIBE THE BENEFITS
    . OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.

 ACTIVITIES
  - Expand IAG study  on  cotton crop ecosystem.   Interactions between non-
    chemical insect/weed control technology as  influenced by fertilization
    and irrigation practices will be evaluated.
  - Conduct technology transfer activities to.educate user community.  Sup-
    port two-day workshops  (co-sponsored with EPA Regional Offices where
    possible)  on IPM  practices applicable in those specific geographical
    areas.     .                        ;

 IMPACT
  - This level will  expand support (including economic evaluation) on a
    portion of the Adkisson proposal which is a-follow-on to the NSF/EPA
    supported Huffaker project.
  - Even at this level, data accumulation will occur at a nearly unacceptably
    slow rate for regulatory needs.
  - Funding at less  than this level is regarded as not sufficiently supportive
  '  of the needs of  OPP nor the requirements of FIFRA in the area of develop-
    ing and implementing alternatives to chemical pesticides for control of
    pests.
         02U
 EPA Form 2410.11 (8.78)

-------
                  ENVIPO'JWPK'TAL PROTECTION

FORM  2;  DECISION DMT LEVEL  ANALYSIS
 , DECISION  UNIT TITLE AND  CODE         HQ       MEDIAj PEST
 1?0  INTEGRATED PESTICIDE MGT (INDUSTRIAL)       APPROj R  & 0
B, RESOURCE  SUMMARY       FY  78 ACT  FY 79  C,  E.   FY BO  INCP   FY  60 CUM
         POSITIONS  PFT
 LEVEL               OPFT
03 OF  10            FTE
   BUUGET  AUTH,  (000,0)       800,0       1,200,0         120.0      1,200,0
  C.  DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
     OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.

 ACTIVITIES
  - Expand IAG study  on soybean crop ecosystem.   Develop expanded predator
    control system and increase emphasis on weed/insect/soybean interrela-
    tionships.
  - Conduct additional technology transfer activities  to educate user
    community.   Try to develop educational handbook materials for distri-
    bution to EPA Regional Offices.

 IMPACT                             - .  '
  - This level will  expand support (including economic  evaluation) on a
    portion of the Adkisson proposal which is a follow-on to the NSF/EPA
  -  supported Huffaker project.
  - Even at this level, data accumulation will occur at a rate which may
    prove to be too  slow for regulatory needs.
  - Funding at less  than this level is regarded as not  sufficiently sup-
    portive of the needs of OPP nor the requirements of FIFRA in the area
    of developing and implementing alternatives to chemical pesticides for
    control of pests.
                                                                     021J
EPA Form 2410-11 (8.78)

-------

















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-------
                     ENVIRONMENTAL PROTECTION AGENCY
FORM 1:  DECISION UNIT OVERVIEW
  A)  DECISION UNIT TITLE (A.\D CODE.)   (E-125)

   Pesticides -  Quality Assurance
                        HQ ORD      MEDIA: Pesticide

                        REG.         APPRO:
  8)  LONG RANGE GOALS & MAJOR OQJECTIVES
 The long-range goal  is to develop  the level of analytical measurement  data
  (chemical, physical, biological) quality which is needed  to allow decisions
 to be made which cannot be  challenged based on the quality of  the 
-------
                                TAL PROTECTION

  FOPM  Ł:  DECISION UNIT LEVEL  ANALYSIS
t
 DECISION UNIT TITLE  AND COPE         HR       ME^IAl PŁST
?5 QUALITY  ASSURANCE-PEST                       APPROj R  &  D
  B. RESOU&CE  SUMMARY       FY  76 ACT  FY 79  C. E.   FY 80  INCR •   FY 60  CUM
           POSITIONS  PFT          fl,o           8.0           6.0           6,0
   LEVEL              OPFT
  01 OF  05            FTE                        8.0           7,0           7.0
     BUDGET AUTH. (000.0)       354.0  .       flOO.O        300.0        300,0
   C.  DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THfe BENEFITS
      OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.

   ACTIVITIES

       o  Complete methcfd performance evaluation for  analytical procedure for
          alkyl phosphate in urine.

       o  Develop standard pesticide reference material  for  alkyl phosphate in
          urine and in soil.

       o  Update and revise quality assurance manual.
                                                            •
       o  Maintain electronic repair and calibration  facility.

       o  Continue bulk materials and analytical"standards repository.
       o  Office of Pesticides Programs contract  laboratories  are serviced
          with minimum level of internal quality  control  tools which include
          SPRM's and electronic equipment repair  and calibration services.

       o  Analytical methods performance evaluations are  greatly limited.  This
          requires the use by OPP laboratories of analytical procedures of
          unknown quality.  The Directors of the  OPP contract  laboratories have
          complained that not sufficient numbers  of  analytical procedures for
          pesticides other than the chlorinated hydrocarbon pesticides have been
          evaluated by critical performance testing, even though over half the
          pesticides in current use fall into the latter  category.

       o  Analyst training seminars cannot be held at this level.  This results
          in general deterioration of the intercomparability of data between
          pesticide residue analytical laboratories.

       o  No provision is made for providing quality assurance overview and
          tools for biological testing laboratories.  This results in biological
          'test data of unknown and challengeable  quality.
 EPA Form 2410-11 (0-78)

-------
                   ENVIRONMENTAL PROTECTION  AGENCV
 FORM ti  OECISIOM  UNIT LEVEL ANALYSIS
 A, DECISION UNIT  TITLE AND  CODE         HQ       HEDJAj  PEST
 Ej?5 UUALITY ASSURANCE-PEST                      APPP.OI  R i D
 B. RESOURCE SUMMARY       FY 78 ACT  FY 79 C.  E.  FY  80 INCR    FY 80
          POSITIONS   PFT          8.0           8.0          1,0           7.0
  LEVEL              OPFT
 02 Of  05            FTE                        6.0            5           7.5
    BUDGET  AUTH,  (000.0)       354.0        400.0         60.0        360.0
  C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
    OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.

     o  Complete analytical methods performance evaluation for toxaphene in
        soil.

     o  Develop SPRM for  toxaphene in human tissue.

     o  Develop SPRM for  toxaphene in soil.

     o  Revise ancLupdate  analytical reference standards manual.

     o  Provide quality assurance assistance to upgrade performance of
        pesticides residue laboratories.

   IMPACT                                   •'

     o  Quality assurance support for an additional  critical priority
        pesticide will  be made available.

     o  Quality assurance overview of the OPP contract  laboratories cannot
        be implemented  at this level of funding.  The laboratories will slowly
        drift out of control and data will  not be intercomparable between
        laboratories.

     o  Analyst proficiency  cannot be maintained because of the lack of
        training program.
         J213
EPA Form 2410-11 (0-73)

-------
                                 L  PROTECTION AGENCY
   ORM Ł! DECISION UNIT LEVEL  ANALYSIS
  r.  DECISION  UNIT  TITLE AND  CODE         HO       MEDIA:  PEST
 El?5 UUALITY ASSURANCE-PEST                      APPRO*  R & D

 B.  RESOURCE  SUMMARY       FY 78 ACT  FY 79 C.  E.   FY  BO  INCR    FY 80  CUM
          POSITIONS  PFT          8,0           8,0           1,0           6,0
  LEVEL              OPFT
 03  OF 05            FTE                        8,0             5           8,0
     BUDGET  AUTH,  (000,0)       354.0        «00,0          40,0        400.0
   C.  DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
      OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.

    ACTIVITIES           .

       o  Conduct  2 interlaboratory performance evaluations of .analysts  in OPP
          contract pesticide residue analytical laboratories.

       o  Begin  analytical methods performance evaluation for alkyl phosphate
          in urine.

       o  Start  development of alkyl phosphate in urine SPKM.

    IMPACT
o
o  The interlaboratory analyst performance evaluation provides  a first
   level  of quality assurance overview which allows documentation of
   analyst proficiency and data quality.

o  There—will  be no training program at this level.  There also will be
   no quality  assurance overview of support for assuring proficiency of
   biological  testing labs.
                                                                       021'j
  EPA Fo.m 2-UO-J1 (B-78)

-------
                           EN'TAL  PROTECTION AGENCY

FORM  ai DECISION UMT  LEVEL  ANALYSIS
A,  DECISION  UNIT TITLE  AND CODE
Ei?5  QUALITY ASSURANCE-PEST
                HQ
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 LEVEL             OPFT
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-------














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                     ENVIRONMENTAL PROTECTION AGENCY
FORM 1:  DECISION UNIT OVERVIEW
A) DECISION UNIT TITLE (AND CODE)                    HO.  ORD

   .Transport, Fate, and Exposure  including  Characte^,
   J — — fc J — __ C Vf —. «. j-*i « v r*.~n ft, .n ^  \jf ^. *• V*   T\*»  "t      <_  /«^^^*V  *»W *tj*
         II r* ._!*! P " *-^i i i PTTt PTi i 	rn P T.!]..^.  I)PTTP IQTIfft^T^.i _  f r
                                                                 MEDIA: PESTICIDE

                                                                 APPRO:  R&D
  B)  LONG RANGE GOALS & MAJOR OBJECTIVES

     Long Range Goals;   To develop improved techniques for exposure assessment
     of pesticides to humans and to the environment.  Exposure estimates are
     needed to define risks a pesticide may produce to humans or the environ-
     ment.

     Major Objective;  To develop improved exposure assessment models for
     pesticides for defining pesticide concentration in multimedia environment;
     to develop improved testing protocols for defining potential hazard of
     pesticides to the environment.  The development of exposure techniques
     and testing protocols require detailed studies on transport, transformation
     and fate of pesticides in air, water, terrestrial and marine environments.

  C)  FY 78 ACCOMPLISHMENTS
                               No Program under this DU.
  D) FY 79 PROGRAM DESCRIPTION
                                No Program under this DU.
EPA Form 2410-10 (8>78)

-------
                  ENVIRONMENTAL PROTECTION AGENCY

FORM  2: DECISION  UNIT LEVEL ANALYSIS

A,  DECISION  UNIT  TITLE AND CODE          HQ       MEDIAf  PEST
E130  PESTICIDES ChRCTRZTN  R MSR^NT MTHS DEVL    APPROj  R & D
mmmmmmmmmmmmmmmmmmmm^mmmm»m»mmmmmmmmmmmmmmm,mm9m»»»»»mmm99mmm^mmmmmmmmm
B,  RESOURCE  SUMMARY       FY 78 ACT FY 79 C. E.   FY *0  INCR    FY 80  CUM
         POSITIONS   PFT                                      70           7.0
 LEVEL              OPFT
04  OF  07             f-TE                                      7.0           7.0
    BUDGET AUTH. (000.0)                                  525.0        525.0
   C.  DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
      OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.

   Activities:  At present there is no base  level program for this DU.   This
   level program addresses limited number of problems which are essential in
   defining human and environmental risks due to pesticides and to the  develop-
   ment of testing protocols for pesticides  transport and fate.  This level is
   also designed to provide technical assistance and data on testing of
   pesticides  in support of the RPAR process.

   o  Technical assistance to the Office  of  Pesticides Program (OPP) in
      providing exposure assessment and relevant test data for OPP designated
      pesticides.                   ^  •.

   o  Development of Exposure Assessment  techniques for RPAR pesticides in food
      chain and multimedia and estuarine  environments.  Determination of
      exposure levels of selected pesticides using this method.

   o  Improved test protocols for possible incorporation into OPP Registration
      Guidelines for use in testing of pesticides in aquatic, marine and
      terrestrial environments.

   o  Transport and transformation data on OPP designated pesticides in aquatic,
      terrestrial, and marine environments.
                                    i i
   o  Development of terrestrial microcosm for screening of pesticides  and
      testing  of selected OPP designated  pesticides using this system.

   Impact;

   o  Funding  at this level would establish  a base level program for transport,
      fate, and exposure of pesticides for providing inhouse technical  expertise
      to OPP.

   o  Funding  at this level would provide exposure estimates on RPAR pesticides.
      These estimates are essential in defining risk under FIFRA.

   o  Funding  at this level would provide OPP necessary protocols to be used in
      testing  of pesticides.

   o  Not funding this level would seriously limit the OPP capabilities to
      regulate pesticides under FIFRA.
 EPA Form 2410-11 (8-78)

-------
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-------
                     ENVIRONMENTAL PROTECTION AGENCY
FORM 1:  DECISION UNIT OVERVIEW
  A)  DECISION UNIT TITLE (AND CODE)

   Registration Standards  (E  205)
HQQTS      MEDIApesticide

REG.         APPRO:  #  r, f '
  B)  LONG RANGE GOALS & MAJOR OBJECTIVES

      As required by FIFRA,  the goal of this program is  to  reduce  the
  adverse environmental  and  public health effects of pesticide  usage
  through a program of  reassessing the Federal Government's regulatory
  position on each of the registered pesticide chemicals.   These   revised
  regulatory positions will  be applied to the regulation of pesticides.

      Specifically, the  objective of this decision unit  is  to develop
  generic standards (consisting of active ingredient or  chemical standards,
  formulation standards,  mixture standards and tolerance standards) which
  will deal with each of  the chemicals used as active ingredients  in pesti-
  cide products.
  C)  FY 78 ACCOMPLISHMENTS

      Completion of a prototype standard for the  herbicide  metolachlor.
  Completion of an analysis  of the production process for preparation
  of  standards.  Selection of  the FY 1979 chemicals  for  which standards  are
  to  be initiated in FY  1979 and preparation of work plans  for  the  first 23
  chemicals, and  initiation of all contracts necessary  for the FY  1979
  effort.

  Formulation of an approach allowing similar pesticides to be  reassesed
  under the same standard and  eliminating from consideration those  pesti-
  cides for which no products  are currently registered.  The new approach
  reduces  from 1400 to 514 the number of standards which must be produced.

  D)  FY 79 PROGRAM DESCRIPTION

       During FY 79 the Agency will be converting from a prototype  to a
  production mode.  This  effort will include:

       Preparation of implementing regulations under the revised FIFRA.
       Completion of procedures manuals  for all phases of the production
       process to include flow charts,  process guides, and  detailed work
       plans and schedules.
       Initiation of standards for 46 chemicals.
       Shakedown and debugging of the entire  production  process.
EPA Form 2410-10 (8-78)

-------
                                   PROTECTION AGENCY

FORM 2:  DECISION UNJT  LEVEL  ANALYSIS
A,  DECISION UNIT TITLE  AND  CODE
E305  REGISTRATION STANDARDS
             MEDJAj  REST
             APPROf  A  4 C
B,  RESOURCE SUMMARY
         POSITIONS  PFT
 LEVEL              QPFT
01  OF  05             FTE
    BUDGET  AUTH.  (000.0)
              FY eo
                        FY  78 ACT FY  79 C. E.
                              84.0        161.0
                               1.0          8.0
                                           159.5
                           1*000.0     11,520.3
C.  DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
   OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.
                    134.0
                      8.0
                    158.9
              FY  80 CUM
                   134.0
                     6,0
                   158.9
                8,400.2
         The number of standards  initiated in FY 1979 that  will  be  completed
    in FY 1980 and the number of  standards that will be initiated in FY  1980
    at this level (and cumulatively) is as follows:
    Active ingredient standards
    Sole active formulation standards
    Mixture standards
    Tolerance standards
COMPLETED
Inc.    Cum
 30     30
120    120
 30     30
600    600
INITIATED
Inc.    Cum.
 36     36
144    144
 36     36
720    720
         The median completion  time  for standards will be 14 months.

         The subtasks involved  in  the completion of a generic standard  include
    screening all published literature, company submitted data,  and other un-
    published information;  seeking public comment and participation;  biblio-
    graphy preparation;  data evaluation and assessment of fate,  effects,
    exposure risk and benefits;  preparing a regulatory rationale and  position;
    completing process documentation; preparing and publishing, the standard
    document; and managing  records with the necessary ADP and micrographic
    support.

         During FY 1980 we  will  be maintaining the prototype standards  completed
    during FY 1978 as well  as initiating maintainance on new standards  as they
    are completed.  The subtasks involved in maintaining completed generic
    standards include screening  all  newly published literature,  new company
    data, laboratory data,  monitoring data, and accident data.   The standard
    will be updated, as necessary  from this material. In addition, this effort
    includes updating standards  to include new uses, new tolerances,  new special
    registrations and new data.
    Impact

         At this level of  funding  the rate of completion of registration
    standards would be 30  per  year.  The project would require  14.7  years  to
    complete if merged during  FY 1981 and successive years  with  level  1 of
    the RPAR Decision Unit (E210).
          J223
   EPA Form 2410-11 (8-78)

-------
                     ENVIRONMENTAL PROTECTION AGENCY

FORM 2:  DECISION UNIT LEVEL ANALYSIS
  A.  DECISION UNIT TITLE (AND CODE)

   Registration Standards  (E  205)  cont.
                   HQ

                   REG.
MEDIA

APPRO:
  B. RESOURCE SUMMARY
FY 78 ACTUAL  FY 79 C. EST.   FY 80 INCR.
      FY80CUM.
LEVEL
-J — OF-5 	
POSITIONS PFT
OPFT
1 FTE
BUDGET AUTH. (000.0)
















  C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
    OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.
      This program would provide for better pesticide regulatory decisions
 through improved scientific reviews, better documentation and more public
 participation. The development of generic standards, rather than making
 regulatory decisions on individual products will result in lowered cost
 and increased efficiency in processing applications for product registra-
 tion.

      The Agency is mandated by law (FIFRA) to reconsider its regulatory
 position on all existing registered pesticide chemicals.  The standards
 program, in conjunction with the RPAR program, is designed to force the
 development of safety data consistent with current standards.  Delays in
 reevaluating all of the pesticide chemicals will potentially expose the
 American people to unnecessary unidentified hazards of cancer, birth de-
 fects, nervous disorders, etc.  These risks can be minimized by adequate
 funding of this activity.
                                                                   0227
EPA Form 2410-11 (8-78)

-------
                   ENVIRONMENTAL  PROTECTION AGENCY

FORM  2: DECISION  UNIT LEVEL ANALYSIS

A,  DECISION  UNIT  TITLE  AND CODE          HQ       MEHI*| PEST
E205  REGISTRATION  STANDARDS                       APpROj A I  C
*"»»»"»«•»<•" ***»»9*mmmmmmmmmmmmmmmmmm + mmm9m + mmmmmmm^mmm>••••••»•  •    M
B.  RESOURCE  SUMMARY       FY 78  ACT FY  79 C.  Ł.   FY  PQ INCR    FY  80 CUM
         POSITIONS   PFT          ea.o        ui.o          27to         161.o
 LEVEL              OPFT           j.o          6.0           2.0          10 0
0?  OF  °5             FT&                      159.5          16.<•         175 3
    BUDGET AUTH.  (000.0)     1,000.0     11,320.3       1,696.1     10,l8d|3
    C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
       OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.


         The number of standards initiated  in FY1979 that will be  completed
    in FY1980 and the number of standards  that will  be initiated in  FY1980
    at this level and cumulatively for levels 1, and 2 is as follows:

                                          COMPLETED      INITIATED
                                          Inc.   Cum     Inc.    Cum.
    Active ingredient standards              5    35       6     42
    Sole active formulation standards       20   140      24    168
    Mixture standards                       5    35       6     42
    Tolerance standards                    100   700     120    840
    Impact

         At this level  of funding the rate  of  completion of registration  stan-
    dards during FY80 will be 35 per year.   The project would require  10.1 years
    to complete if merged during FY81 and successive years with level  4 of the
    RPAR Decision Unit  (E210).

         Not funding this level would further  delay the generic standards system
    (as well as slowing the conditional  registration program) and would push the
    completion of reregistration into the future.
   EPA Form 2410-11 (8-78)

-------
                  ENVIRONMENTAL  PROTECTION AGENCY
FORM  21  DECISION UNIT  LEVEL  ANALYSIS
A, DECISION  UNIT TITLE  AND CODE
E205  KE&ISTRATION STANDARDS
                                            HO
                         MEDIAj  PEST
                         APPROi  t  & C
B, RESOURCE  SUMMARY
         POSITIONS  PFT
 LEVEL              OPFT
03 OF  P5            FTE
   BUDGET AUTH,  (000.0)
FY 78  ACT FY  79 C. E.
     84.0        161.0
       1.0          8.0
                  159.5
  1,000.0     11,320,3
                                                      FY 80  INCR
                                                             18.0
                                                              1.0
                                                             16.«
                                                         1.132.0
             FY 80  CUM
                  179,0
                   11.0
                  191.7
              11,320.3
    C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
      OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.
         The number of standards initiated in FY1979  that will be completed
     in FY1980 and the number of standards that will be initiated in FY1980
     at this level and cumulatively for  levels 1, 2, and  3 is as follows:
     Active ingredient  standards
     Sole active formulation standards
     Mixture standards
     Tolerance standards
                                         COMPLETED
                                         Inc.   Cum
                                                 38
                                                153
                                                 38
               3
              13
               3
              66
                                                766
INITIATED
Inc.   Cum.
  4    46
 16   184
  4    46
180   920
     Impac t

         At this level of funding the  rate of completion  of registration
     standards during FY80 would be 38  per year The project would require  11.7
     years to complete if merged during FY81 and successive years with level 3
     of  the RPAR Decision Unit (E210).
   EPA Form 2410-11 (8-78)

-------
                  ENVIRONMENTAL PROTECTION  AGENCY

FORM  g: DECISION UNIT LEVEL  ANALYSIS
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-------
                     ENVIRONMENTAL PROTECTION AGENCY

FORM 1:  DECISION UNIT OVERVIEW
 A)  DECISION UNIT TITLE {AND CODE)                    HOOTS      MEDIA: Pesticide!

         REAR Chemical Review   (E210)              REG.        APPRO: A  & C
  B)  LONG RANGE GOALS & MAJOR OBJECTIVES
  The principal objective of the Rebuttable Presumption Against
  Registration program is to identify pesticides suspected of having
  an adverse effect on the environment, analyze the pesticides' benefits
  and risks, and take regulatory action to remove the pesticide
  from, or return it to, the market.  Also included in this decision
  unit is the laboratory audit program.  The objective of this program
  is to determine the accuracy and reliability of animal study test
  data submitted in support of pesticide registration applications
  C)  FY 78 ACCOMPLISHMENTS and tolerance petitions.

  A final decision document was prepared on the chemical DBCP.  Another
  15 chemicals were in various stages of review, after the decision to
  submit the chemicals to RPAR procedures, including analysis of the
  exposure of humans and the environment to the pesticide; analysis for
  oncoginicity, terotogencitiy and carcinogenicity risk; review of .the
  benefits of the different uses of the pesticide, often based on data
  supplied by the Department of Agriculture; review of the possible
  substitutes for the chemicals; and assessment of the possible regulatory
  options.  Initial analyses, resulting in the issuance of RPAR notices,
  were completed for 11 chemicals.  Thirty seven compounds were reviewed
  and 15 were recommended for a pre-RPAR review  (which could result in
  the decision to issue an RPAR notice.  Three chemicals were voluntarily
  cancelled, a notice of intent to cancel was issued for one chemical and one
  chemical was returned to the registration process.  Agreement was reached
  with the Department of Agriculture which resulted in the formation of
  DQA/EPA assessment teams for 24 chemicals.

  As part of a special program to assess the extent of risk associated
  with the use of pesticides containing Dioxin 105 samples were collected
  to determine the presence of dioxin in human milk and urine, 271
  samples of various orgins were analyzed to determine the statistical
  validity of dioxin analyses and the lower limit of detection, and
  82 samples were analyzed to determine whether detectable levels of
  dioxin were present in fish, soil and human tissue.

  A total of 70 audits were performed by the Food and Drug Administration
  for EPA.  Of the audits performed to date, 3 have been referred for
  enforcement action (2 to the Department of Justice).  The most notable
  case referred to the Department of Justice involves Industrial Biotest
  Laboratories.  Because of the questions raised by the validity of data
  resulting from IBT tests, EPA has initiated a special program to audit
  IBT test and has required all registrants whose tests were performed
  by IBT to certify to their validity before they are used to support a
  registration application or tolerance petition.  EPA is reviewing
  these study validations by registrants.                            ,o^ -,
                                                                    UZc o
 EPA Form 2410-10 (8.78)

-------
                     ENVIRONMENTAL PROTECTION AGENCY

FORM 1:  DECISION UNIT OVERVIEW
  A)  DECISION UN IT TITLE (AND CODE)                    HOOTS      MEDIA: Pesticides

         RPAR Chemical Review    (E210)             REG.         APPRO: A & C
    D)  FY 79 PROGRAM DESCRIPTION

    In FY 1979 final decision documents will be prepared for 23
   RPAR chemicals.  Administrative hearings will be conducted
   for about one half of the cases on which final decisions
   are reached.  RPAR notices will be issued for 19 chemicals
   suspected of having an adverse effect on humans or the
   environment.  The Dioxin sample analysis will be coipleted
   in FY 1979.  Seventy laboratory audits will be perfonted.
   by the Food and Drug Administration for EPA, 12 audits will
   be performed of 1ST studies and 300 registrant validations
   of IBT studies will be audited.
        J2C <
EPA Form 2410-10 (8-78)


      .  . _   ._  . _  	  . .   \.

-------
                  ENVIRONMENTAL  PROTECTION AGENCY

FORM  as DECISION  UNIT LEVEL ANALYSIS

A. DECISION  UNIT  TITLE  AND CODE          HQ       MEDIA| PEST
E210  HPAR  REVIEWS                                   APPRCj A  &  C

B. RESOURCE  SUGARY       FY 76  ACT FY  79 C.  E.  FY  BQ INCR   FY  80 CUM
         POSITIONS   PFT         153.0        173.0        130,0        130.0
 LEVEL              OPFT           7.0           4,0          4,0          4,0
01 OF  i)b             FTE                      175.3        157.2        157.2
   BUDGET  AUTH, (000.0)    13,552.0     14,799.5     10,090.6     10,090,6
    C.  DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
       OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.

    At this level final decision documents will be prepared  for 15 RPAR
    pesticides chemicals suspected of having an adverse effect on man
    or the  environment.  Decisions on whether to issue an  RPAR will
    be made after data gathering and evaluation on 13 pesticide chemicals.
    Eight administrative hearings  will be conducted which  will permit
    technical and scientific support.

    Under the laboratory audit program  60 laboratories presently
    carrying out chronic feeding and other studies on laboratory animals
    will be audited.  Twelve audits of  individual toxicology studies
    performed by Industrial Biotest Laboratories will be conducted.  This
    level will also permit evaluation of 150 registrant audits of toxicology
    studies performed by IBT.

    Impact

    Funding this level will permit the  continuation of a minimal rebuttable
    presumption  program and the maintenance of a "Federal  interest" in the
    laboratory audit program.

    Not funding  this level would leave  unresolved, RPAR proceedings
    on 15 chemicals referred for review.  No additional chemicals would
    be added to  the RPAR list.   The laboratory audit program including
    the special  audit of IBT testsf would be discontinued.
                                                                    02:5
   EPA Form 2410-11 (8-78)

-------
                   ENVIRONMENTAL PROTECTION AGENCY
FORM  2!  DECISION UNIT  LEVEL  ANALYSIS
A,  DECTSION UNIT  TITLE  AND  CODE
E210  KPAR  REVIEWS
HQ
MEDIAJ
APPRO!
PEST
A &  C
8, RESOURCE SUMMARY

LEVEL
02 OF 0
D U L* ' *
POSITI

6
tT AUTH
ONS PFT
OPFT
FTE
. COOO.O)
FY 78 ACT F
153.0
7.0

13,552.0
Y 79 C. E. FY BO INCR
173.0
4.0
175.3
l«f 799. 5
13.0

6.5
1,693.1
FY 80 CUM
143.0
a.o
163.7
11,783,7
    C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
       OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.


    Funding at this level will permit the completion  (thru the issuance
    of the Administrators Final  Decision) of 3 additional KPAR reviews.

    It will not permit data gathering and evaluation to decide whether
    or not to issue an KPAR on 2 additional  pesticides.  One additional
    administraive hearing will be conducted.  Ten laboratories will
    be audited.   An additional 150 registrant audits of toxicology
    studies performed by IBT will be  evaluated.

    Impact

    Funding this level will permit the  completion of 3 additional KPAR
    decisions and the continuation of the laboratory audit program
    at a reasonable level.  Not  funding this level would leave unresolved,
    proceedings on chemicals which may  have  adverse effects.  The
    laboratory audit program would be operated at a minimal level.
            02:
  EPA Form 2410-11 (8-78)

-------
                  ENVIRONMENTAL PROTECTION  AGENCY
   ^1  2:  DECISION UNIT LEVEL  ANALYSIS
A, DECTSTON  UNIT TITLE AND  CODE
E210  KPAR REVIEWS
                HQ
MEDIA!  PEST
APPRO!  A § C
R, RESOURCE  SUMMARY
         POSITIONS  PFT
 LEVEL              OPFT
03 of  f't>            FTE
   BUDGET AUTH. (OOQ.O)
FY 78  ACT FY  79 C. E.
     153.0        173.0
       7.0          «,0
                  175.3
 13,552.0     14,790.5
 FY  BO
        13.0

         6.5
       325.0
FY 80
     156,0
       «.0
     170.2
 12,108.7
     C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
       OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.
    At this  level final decision documents will be prepared on an additional
    2 chemicals which are suspected of having an adverse effect on man or
    the environment.  This level will also permit data gathering and evaluation
    to decide whether or not to issue an KPAR on 2 pesticide chemicals.  One
    additional administrative hearing will be conducted.  Ten laboratories
    will be  audited and 40 registrant audits will be evaluated.

    Impact
    Funding this level will permit completing 2 additional KPAR decisions
    and conducting an adequate laboratory audit program.
                                                                   02^7
   EPA Form 2410-11 (8-78)

-------


















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-------
                     ENVIRONMENTAL PROTECTION AGENCY

FORM 1:  DECISION UNIT OVERVIEW
  A)  DECISION UNIT TITLE (AND CODE)
        RPAR Chemical Review   (E210)
HQ

REG.
MEDiAPesticides

APPRO:
  B)  LONG RANGE GOALS & MAJOR OBJECTIVES


  The long term goals for regional office participation in the RPAR
  program are to establish public outreach programs to maximize
  public input to the RPAR process, to  increase regional participation
  in  EPA-USDA Benefits Assessment Team  efforts to collect and review
  benefits,  use,  and safety data pertaining to RPAR chemicals, and to
  assist in conducting administrative hearings to reach final decisions
  on  reduction of unreasonable adverse  health and environmental effects.
  In  addition,  regional offices will be expected to investigate and
  coordinate pesticide incident information on human and for environmental
  effects as necessary to support the RPAR program.

  C)  FY 78 ACCOMPLISHMENTS

  In  accordance with the  management responsibility guide on the role of
  regional offices in the RPAR process, the regions responded to public
  inquiries  on the RPAR procedures and  specific RPAR issues, and "
  solicited information from public, trade, farm, and environmental
  associations and state  and federal agencies to ensure that the
  RPAR decisions  are based  on the greatest possible amount of
  available  information.  In addition,  the regions cooperated with
  headquarters and USDA to  obtain Integrated Pest Management infor-
  mation with respect to  RPAR chemicals.
  D)  FY 79 PROGRAM DESCRIPTION

  In FY 79 regional offices will be expected to continue FY 1978
  activities and to review Assessment Team work plans, prepare
  benefit data on minor crops and non-agricultural uses not covered
  in Assessment Team plans; establish working agreements with states
  as appropriate; establish contact points with all affected groups
  to ensure that all sources of data are used in the RPAR
  process; provide usage, benefit, and data to headquarters;
  and review and verify RPAR chemical use profile and position documents
  provided by headquarters.
EPA Form 2410.10 (8-78)

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                   ENVIRONMENTAL PROTECTION

FORM  2:  DECISION UNIT  LEVEL  ANALYSIS
A,  DFCISION UNIT TTTLF AND  CODF          RG       MFUIAf  PEST
F210  RPAR  REVIEWS                                   APPROt  «  & C
B.
! C
RESOURCE SUMMARY
POSITIONS PFT
FY
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C. E.
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FY
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5.0
01  OP  07             FTE                        ia.O           8.5           8.5
    miUGtl  AUTH.  (000,0)        339.0        357.9         137.9         137.9
    C.  DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
       OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.

    Regions  IV, V, VI, IX, and X will respond to all public inquiries,
    solicit  public, trade and farm association,  state and federal agencies,
    user, and environmental group participation in RPAR by telephone,
    mailings, meetings, and news media.  Ihese Regions will also review
    all EPA/USDA Assessment Team work plans, submit PIMS reports relevant
    to  RPAR, review and provide oral and limited written comments on
    position documents, and include Regional IPM information in RPAR
    decision documents, but only through cursory telephone communications
    witn  states.

    Impact

    Funding  this level would enable Regions in which significant RPAR
    activity is projected for 1980 to provide input into the process,
    expanding its scope and validity with geographically pertinent
    information.  The diversified data obtained by these regions
    from  states, registrants and environmental groups would make
    Agency decisions more sound.

    Without  funds for these Regional positions,  the RPAR process would
    suffer from a lack of sufficient input from concerned groups
    outside  the Agency.  As a consequence, RPAR decisions would be
    based only on the information received through headquarters,
    USDA-EPA Benefits Assessment Team,  and Federal Register Notice
    solicitations.  Many local trade, user, and environmental groups
    which would otherwise be contacted by the Regional offices,  would
    effectively be eliminated from that decision-making process which
    critically affects them.
                                                                     U2U
  EPA Form 2410-11 (8-78)

-------
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-------
                     ENVIRONMENTAL PROTECTION AGENCY
FORM 1:  DECISION UNIT OVERVIEW
  A)  DECISION UNIT TITLE (AND CODE)
          SPECIAL REGISTRATIONS (E-215)
HO   OTS

REG.
MEDIAPESTICIDES

APPRO: A&C
  B) LONG RANGE GOALS & MAJOR OBJECTIVES


   Complete review of each  section  5 Experimental Use Permit request within 90
   days  of  receipt.   Take final  action on  emergency exemptions within two weeks
   of receipt.   Provide guidance to States relative to  their section 5(f)
   Experimental  Use  Permit  and section 24(c) registration activities and
   conduct  overview activities on their  final actions.  Provide guidance to
   minor use/specialty crop petitioners  and registrants.  Fully delegate
   section  24(c)  registration responsibilities  to all Regions.
  C) FY 78 ACCOMPLISHMENTS
  Approximately  225  section 5 Experimental Use Permit applications, 140
  section  18  emergency exemption actions, and 1,140 section 24(c) state
  registrations  were reviewed.  Support for the minor use program was provided
  including coordinating review of petitions and serving as liaison with minor
  use  interest groups.
  D)  FY 79 PROGRAM DESCRIPTION
  A highly satisfactory level of service will be provided on all special
  registrations mandated under the amended FIFRA, section 5, 18, and 24(c).
  Experimental Use Permits will be processed within 90 days of receipt;  all
  follow-up EUP reports will be evaluated; delinquent reports will be
  requested and reviewed.  There will be scientific evaluation of data
  submitted in support of section 24(c) actions.  However,  data will be
  requested on only a small portion of actions.   Increased  guidance will be
  provided to the IR-4 petitions for minor crop  uses.  A high degree of
  timeliness and quality will be achieved in processing section 18 emergency
  exemptions.  The feasibility of delegating the section 24(c) function  and
  some aspects of the section 18 function will be examined.
                                                                     02^5
EPA Form 2410-10 (8-78)

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                            ENTAL PROTECTION

      2t DECISION  UNIT  LEVEL  ANALYSIS
A.  DECISION UNIT  TITLE  AND  CODE          HO       *FDIAj PEST
F.215  SPECIAL REGISTRATION                          APPROI A  &  c
B.  RESOURCE SUMMARY       FY  78 ACT  FY 79  C. E.   FY  RQ INCR   FY 80  CUM
         POSITIONS  PFT          56.0          64.0          al.O         41,0
 LEVEL              OPFT           2.0           3.0           J.O           3.0
01  OF  Ob             FTF.                        6B.3          56.8         56,8
    BUDGET  AUTH.  (000.0)        970.0       1,621.2       1,013.3      1,013.3
    C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
      OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.

   ACTIVITIES

   Section 18 Emergency  Exemptions.  Process 120 requests,  each  issuance
   granted within  5 weeks maximum; publish in Federal  Register.  Depending on
   the results of  the  review  in FY 1979 of regional capabilities and the level
   of regional special registration budgeted in FY 1980,  processing of some
   18's will be accomplished  in the regions.  Since the vast majority of
   requests are highly complex and/or controversial,  only a small percentage
   will be likely  to go  to  the Regions; therefore, it  is  not expected that the
   Headquarters manpower requirements would be reduced by the delegation.  This
   delegation of authority  to the Regions would be in  addition to their other
   responsibilities relating  to section 18, such as monitoring of granted
   exemptions.

   EUP Applications and  Petitions for Temporary Tolerances. Process 250 EUP
   applications and 85 temporary tolerance petitions,  each  within a maximum of
   240 days of receipt.  Conduct only miniumum required hazard,  residue, and
   efficacy review except for in-depth evaluation of human  and environmental
   impact data for new chemicals.

   State-Issued 24(c) Registrations and 5(f) EUP's.  Headquarters will oversee
   regional participation in  the section 24(c) program and  a pilot program to
   delegate 5(f) functions  to several regions will be  developed.  An expected
   1,500 section 24(c) registrations and 50 section 5(f)  EUP's will be logged
   in.  The increase in  24(c)'s is based on almost all States being certified
   and becoming increasingly  familiar with the procedures.  As the proposed
   FIFRA amendments provide greater flexibility for the States,  the number of
   registrations may be  even higher.  It is expected that even if the regional
   delegation takes place,  Headquarters would be expected to maintain a file of
   issued 24(c)'s  and 5(f)'s.  There would be no expectation of  reduced
   manpower in headquarters at this level of activity.  NOTE:  There is no
   provision of scientific  support for 24(c)/5(f)  in this increment.
   Administrative/clerical  support is included to cope with recordkeeping only.

   Minor Use Support.  Provide liaison with USDA and others (such as the
   Interregional Project No.  4 at Rutgers University)  regarding  clearance for
   minor uses.
 EPA Form 2410-11 (8-78)

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                      ENVIRONMENTAL PROTECTION AGENCY
FORM 2:  DECISION UNIT LEVEL ANALYSIS
  A.  DECISION UNIT TITLE (AND CODE)

             SPECIAL REGISTRATIONS (E-215)
                    HO  OTS      MEDIA: PESTICIDES

                    REG.         APPRO:  A&C
  B.  RESOURCE SUMMARY
FY 78 ACTUAL  FY 79 C. EST.  FY80INCR.
FY80CUM.
LEVEL
-i-OF-S-
POSITIONS PFT
OPFT
FTE
BUDGET AUTH. (000.0)
















  C.  DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
     OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.
  IMPACT
  This level provides the minimum level of service on all special registration
  actions as mandated in the amended FIFRA, sections 5, 18, and 24(c).  Any
  lesser depth of review would result in grossly inadequate protection of
  public health and the environment; any longer delays would be entirely
  unacceptable.  Not funding this level would result in a failure to respond
  to statutory obligations.

  GAO has indicated to Congress its serious concerns about the sections 5, 18,
  and 24(c) programs.  They are especially concerned about the lengthy
  turnaround times for EUP's and emergency exemptions (sections 5 and 18,
  respectively).   Funding only this level would increase the processing time
  for these actions.  GAO has also indicated that the programs are not
  monitored thoroughly enough and that EUP reviews give insufficient
  information as  to future registration requirements.  State programs need to
  be closely monitored until the Agency can be assured that States will
  conduct their 24(c) programs in the manner EPA intended.  Such monitoring is
  not provided at this level.
EPA Form 2410-11 (8-78)

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                   ENVIRONMENTAL PROTECTION AGENCY

FOPM as  DECISION UNIT LEVEL  ANALYSIS
              ^***r****>**>*>***>*l>****l>>*t**^^^M
A.  DECISION UNIT TITLE AND  CODE          HO       MEDIA*  PFST
E215 SPECIAL REGISTRATION                          APPRO*  «  1 C
B.  RESOURCE SUMMARY       FY  78 ACT FY  79C.  E.  F Yo
         POSITIONS  PFT         56.o         6<*.c           9.0          50.0
 LEVEL              OPFT          2.0           3U           10           2 o
02  OF  06             FTE                       66.3           5.9          62 7
    BUDGET  AUTH.  (000. 0)        970.0      1,621.2        202.6      1,215 9
    C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
      OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.

  ACTIVITIES
  Section 18 Emergency Exemptions.  Process each request within four weeks
  maximum.  Prepare status  reports and detailed records of all requests  and
  EPA actions.

  EUP Applications and Petitions  for Temporary Tolerance.  Achieve faster
  scientific and administrative  processing; process each application within
  210 days of receipt.   Provide  regions with copies of issued permits,
  labeling, and experimental  programs.  (Regional monitoring of EUP' s  is
  dependent upon this information.)

  State-Issued 24(c)  Registrations and 5(f) EUP's.   Code minimum data from
  1,500 24(c)'s and 50  5(f)'s  for computer storage.  Scan 24(c)  and 5(f)  EUP
  notifications for illegal  or improper actions; disapprove or provide for
  other corrective action (regions monitor State records of 24(c)  and 5(f)
  activities.)

  IMPACT
  - Funding this level will  provide  slightly better than minimum response to
  the requirements of the  amended FIFRA.  Emergency exemption actions  will be
  more timely.  EUP's will have minimal  level of review; emphasis will be
  placed on improving timeliness of  Agency response which is greatly desired
     applicants.  Timeliness of Agency review of 24(c)'s will be in. accord
  with statutory limits (if  such are retained in amended FIFRA); emphasis will
  je on detection of general and individual problems with registrations and
  transtnittal of guidance  to States.  Attention will also be given to  reducing
  response time on 24(c)'s when possible.  As indicated in level 1, certain
  actions may be delegated to Regions for processing.

  - Not funding this level will result in a great deal of economic loss and
  registrant dissatifaction  because  of the slow response to actions which
  demand rapid completion.

  NOTES
  Depending on the results  of  the review in FY 1979 of regional capabilities,
  processing of 24(c)  registrations and some 18's will be delegated to
  regions.
  EPA Form 2410-11 (8-78)

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                   ENVIRONMENTAL PROTECTION

      2;  DECISION UNIT LEVEL ANALYSIS
A.  DECISION UNIT TITLE AND  CODE          HS       MEDJAj  PEST
EB15 SPECIAL  REGISTRATION                          ARPROj  A  * C
*****^***w*******************w<*i»w<*w*|pipww»**^»»viw»w»»^»»i^i^a»»>»«»a»v*»>^w*vi»**(p)
B,  ^ESOUPCE SUMMARY       FY 76  ACT FY  79 C.  E.   FY RQ  INCR    FY 80  CUM
          POSITIONS  PFT         56. o          6«.o           5,0          55.0
 LEVEL              OPFT           2.0           3.0                         a.O
03  OF 06             FTL                        68.3           2.5          65.2
    BUDGET  AUTH.  (000.0)       970.0      l,6?1.2         135.1      1,351.0
  C.  DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
     OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.

  ACTIVITIES

  Section 18  Emergency Exemptions.  Process requests  more  rapidly, each within
  three weeks maximum.  Prepare status reports and  detailed records of all
  requests and EPA actions.  When necessary, update guidelines  for
  (1) coordinating HQ/Regional response  to  requests for emergency exemptions,
  and (2) coordinating issuance of exemptions.

  EUP Applications and Petitions for Temporary Tolerances.  Achieve faster
  scientific  and administrative processing; each application processed within
  180 days of receipt.  Evaluate 100 (10%)  of the required follow-up reports.
  Forward copies of significant periodic reports to Regions for monitoring
  activities.

  State-Issued 24(c) Registrations and 5(f) EUP's.  Scan 24(c)/5(f) notifica-
  tions for blatantly  illegal actions; and  advise States of corrective action.
  Disapprove  if  situations are not corrected.
  IMPACT

  - Funding this  level will provide internal studies  and  quality checking
  which is important  to the special registration program.   Emphasis will be
  continued on  decreasing turnaround times for 18's and EUP's with less
  attention to  improving quality of EUP's.  There will be continued emphasis
  on closer review of 24(c) "s with transmittal of more detailed information to
  States and an increase in minor use support.

  - Not funding this  level will leave the program at  an inadequate level of
  response to applicants and without critical internal studies and record
  keeping.
  NOTE

  Depending  on  the results of the review in FY 1979  of  regional capabilities
  and the level of regional resources in FY 1980,  processing  of 24(c)
  registrations and some 18's will be delegated to regions.
EPA Form 24)0-11 (8-78)

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                   ENVIRONMENTAL PROTECTION  AGENCY

FOR"  3: DECISION UNIT  LEVEL  ANALYSIS
A,  DECISION UNIT  TITLE  AND  CODE          HQ
E2i5  SPECIAL REGISTRATION                          APPRUI  A &  c

B.  RESOURCE SUMMARY       FY  78 ACT  FY 79  C. E.   FY  &l  INCR
         POSITIONS  PFT          56,0          64.0           fe.O         61.0
                     OPFT           2.0           3.0                         a!o
    O   °b             FTE                        6B.3           3.0         68.2
    BUDGET  AUTH.  (000.0)        970.0       1,621.2         1JS.1      UUS6.1
     C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
       OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.

     ACTIVITIES

     Section 18 Emergency Exemptions.  Process requests more rapidly,  each  within
     2 weeks maximum.

     EUP Applications and Petitions  for  Temporary Tolerances.   Achieve scientific
     and administrative processing,  each application processed within  120-150
     days of receipt.  Evaluate an additional 15 of required follow-up periodic
     reports.   Forward copies of significant reports to regions for monitoring
     activities.  Review 100 revised labels, about half of required amount.

     State-Issued 24(c) Registrations  and 5(f) EUP's.  Conduct, a more  detailed
     review of  labels and forms submitted for 24(c)'s and 5(f) EUP's.   Conduct
     superficial review of 5(f) experimental programs.  Provide any additional
     needed forms and guidance information  to State lead agencies.

     Minor Use  Support.  Coordinate  with science branches the continuing effort
     to establish tolerances or issue  registrations with less than  the amount  of
     data required for a major crop.  Determine types of data necessary to
     support additional given minor  uses.
     IMPACT
     -  Funding  this level will provide  adequate but less than optimal special
     registration activities with review,  acknowledgement, and follow-up services
     required a responsive program.   Response  time is improved in all activities.
     Emphasis is continued on quality in  the 24(c) review program.  Increased
     effort  is directed to the minor use  program.

     -  Not funding this level will result  in an incomplete special registration
     program that provides improved  response times but does not provide the
     review, acknowledgement, and follow-up services necessary in a program of
     good quality.
     NOTE

     Depending on the results of the review in FY 1979 of regional capabilities,
     processing of 24(c) registrations  and  some 18's will be delegated to
     regions.
                025- J
  EPA Form 2410-11 (8-78)

-------

-------

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                   ENVIRONMENTAL  PROTECTION  AGENCY

                    UNIT l_ev/FL ANALYSIS
A,  DECISION UNIT TITLt AND CODE         HQ       MEDJAj PEST
E215 SPECIAL  REGISTRATION                           APPRQj A  & C
B, RESOURCE SUMMARY
POSITIONS PFT
LEVEL OPFT
OS OF 06 FTE
BUDGET AUTH, (000,0)
FY 78 ACT
56,0
2.0

970,0
FY 79 C. E.
6«.0
3.0
66,3
1,6?1.2
FY BO INCR
5,0
1.0
4.9
135.1
FY 80 CUM
66,0
5.0
73, l
1,621.2
    C.  DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
       OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.

    ACTIVITIES

    Section 18  Emergency Exemptions.  Acknowledge receipt of all requests.
    Review  and  file  all  final  reports submitted by exemptees.

    EUP Applications and Petitions  for Temporary Tolerances.  Achieve faster
    scientific  and administrative processing, each application processedwithin
    90-120  days  of receipt.  Review 200 additional periodic reports, about 50%
    of  estimated total requirement.   Forward copies of significant reports to
    regions for  monitoring activities.  Review an additional 100 revised labels,

    State-Issued 24(c) Registrations  and 5(f) EUP's.  Review 24(c)'s and 5(f)'s
    for less obvious discrepancies  and take  corrective action as necessary.
    Include appropriate  comments and  constructive criticism in response letters
    to  States.   Conduct  scientific  evaluation of 10% of submitted data and test
    programs for validity and  legal adequacy.  Include applicable comments in
    acknowledgement  letters.
    IMPACT

    -  Funding  this  level will  provide the Agency with a special registration
    program which  is well  suited  to  registrant needs, including the rapid and
    timely  issuance of  emergency  exemptions and experimental use permits.  Data
    supporting 24(c) registrations will be spot-checked and evaluated for
    adequacy.   Increased support  will be provided for specific minor uses.

    -  Not funding  this  level would result in emergency exemptions and
    experimental use permits not  being issued as rapidly as desired and the
    Agency  would not be fully  responsive to applicants.  Some exemptions would
    be granted too  late to fully  accomplish the intended purpose; some
    experimental use permits may  be  issued too late for the applicant to begin a
    useful  experimental program.
    NOTE

    Depending  on  the results of the review in FY 1979 of regional capabilities
    and  the  level of regional resources  in FY 1980, processing of 24(c)
    registrations and  some  18's will be  delegated to regions.

                                                                       0251
  EPA Form 2410-11 (8-78)

-------














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                     ENVIRONMENTAL PROTECTION AGENCY

FORM 1: DECISION UNIT OVERVIEW
  A) DECISION UNIT TITLE (AND CODE)                   HQ          MEDIA:PESTICIDE:

         SPECIAL REGISTRATIONS (E215)               REG.  X      APPRO:  A&C
  S) LONG RANGE GOALS & MAJOR OBJECTIVES

    Regions operate section 24(c)  special local needs totally with  only  a  com-
    puter file maintained in headquarters.   This program would involve both an
    audit of State performance on  an annual or semi-annual  basis  as well as the
    review of specific actions for conformance with  legal requirements.

    Regions operate "field" aspects of section 18 emergency exemption program.
    This will include determining  (a)  the need for an exemption,  (b) whether
    the proposed  solution will be  efficacious  and (c)  what  local  environmental
    problems may  occur.   The regions will also follow-up State reports.

    Regions monitor section 5 experimental  use permits issued by  headquarters.
    When the section 5(f) regulations  are promulgated,  the  regions  will  assist
    the States in development of their plans,  review State  plans  and monitor
    the State issuance  of permits.
  C) FY 78 ACCOMPLISHMENTS


    Provided  vital  support  to  section 18 emergency exemption program.  Provided
    guidance  to  States on their section 18 and section 24(c) activities.
    Several regions provided extensive support to headquarters on section 24(c)
    State registrations.  Continued participation in section 5 experimental use
    permit program.
  D) FY 79 PROGRAM DESCRIPTION


    Seven regions will review section 5 experimental use permits, section 18
    emergency exemptions, and section 24(c) State registrations on a clerical
    and  technical level.  The feasibility of delegating to the regions the sec-
    tion 24(c) function, and some aspects of the section 18 function will be
    examined.  Regions will provide guidance to States as needed.
                                                                    0255
CPA Fom 2470-10 (8-78)

-------
                  ENVIRONMENTAL  PROTECTION AGENCV

FORM  d:  DECISION UMIT  LEVEL  ANALYSIS
A, DECISION  UNIT TITLE AND CODE         RG       MEHlAj  PEST
E21S  SPECIAL  REGISTRATION                         APPRO*  ARC

R, RESOURCE  SUMMARY       FY  76  ACT FY  79 C.  E.   FY  *<0  INCR    FY 60  CUH
         POSITIONS  PFT         20.0           7.0           4,0           fl,0
 LEVFL              OPFJ
01 or  Ob            ME                       15.5           5.5           5.5
   BUDGET AUTH.  (000,0)        256.0        362.2         119,0         119.0
   C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
     OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.
   ACTIVITIES

   Several  regions will review section 18 emergency exemptions,  section 5 ex-
   perimental use permits,  and section 24(c)  State registrations  issued within
   their regions on a clerical level.  The regions will also respond to
   queries  from State agencies.
   IMPACT
   - Funding this level will permit the performance of the minimal level of
   activities mandated by Congress in several  regions.

  , - Not funding this level will result in no  regional monitoring of special
   registration programs. No regional responsibility will be  retained for
   these activities; all actions will be referred to headquarters.
       0213

-------
                  ENVIRONMENTAL  PROTECTION  AGENCY

FORM  f.  DECISION UNIT  LEVEL  ANALYSIS

A. DECISION  UNIT TITLE AND  CODE         RG       MfDJAt PEST
E215  SPECIAL  REGISTRATION-                         APPRm A  &  C
B. REJDURCF  SUMMARY       FY  78 ACT  FY 79  C.  F, .  FY  80 JNCR   FY  80 riJM
         POSITIONS  PFT          20.0           7.0          7.0         n.o
 LFVfL              OPFT
o? OP  06            FTE                        13.5          5,5         11.0
   BiHT-tT AUTH.  (ooo.o)        ?58.n         3fe2.2        187.7        306.7
    C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
      OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.
    ACTIVITIES

    All regions review section J8 "emergency exemptions,  section 5 experimental
    use permits, and  section 2A(c) State  registrations on a  clerical level.
    All regions will  respond to inquiries from State agencies.
    IMPACT

    - Funding this  level will permit  the  performance of the minimal level of
    activities mandated by Congress in all regions.

    - Not funding this level will result  in no regional monitoring of special
    monitoring programs in six regions.
  EPA Form 2410.11 (8-78)

-------
                            ENTAL PROTECTION AGF.MCY

FORM  2\ DECISION  UNIT LEVEL ANALYSTS
A.  DECISION  UNIT  TITLE  AND CODE
E21S  SOCIAL REGISTRATION
                RG
       MEDIA:  PEST
       APPRO;  A &  C
B.  RESOURCE  SUMMARY
         POSITIONS   PFT
 LEVEL              OPPT
03  OF  oo             FTE
    BUDGET  AUTH.  (000.0)
FY 78  ACT FY  79 C.  E.
      20.0           7.0
        FY
     358.0
 13.5
362.2
 3.0

 3.0
47.2
FY  80 CUM
      14.0
     353.9
   C.  DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
      OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.
   ACTIVITIES
   Region IX will  receive two additional  positions to permit the complete  re-
   view of section 24(c) special local  needs registrations and development of
   four state plans  for State experimental  use certification under 5(f).

   Region X will receive an additional  position for the technical review of
   section 18 and  24(c) actions.  Conduct evaluations prior to submittal of
   section 18 requests.  Provide overview of one state 5(f) plan.  Restore
   compliance monitoring for 15% of section 24(c) registrations and 5(f) ex-
   perimental use  permits.
   IMPACT
   '- Funding this level will allow Region  IX to carry out full section  24(c)
   responsibilities as delegated.  Region  X will also be able to provide head-
   quarters  with vital input on the section 18 and 24(c) programs.

   - Not funding this level will severely  impact on Region IX's capability to
   conduct complete reviews of section 24(c) registrations.  Not providing the
   extra manpower to Region X will put the full burden of section 18  review
   back on Headquarters.
  EPA Form 2410.11 (8-78)

-------
                              TAL  PROTECTION AGENCY
FORM  d\ DECISION  UNIT LEVEL. ANALYSIS
A.  DECISION  UNIT  TITLE  AND CODE
E215  SPECIAL REGISTRATION
           RG
                               i PFST
                         APPRO! A  &  C
R.  RESOURCE  SUMMARY
         POSITIONS   PFT
 LEVEL              0?FT
oa  OF  ob             FTE
    BUDGtT  AUTH.  fOOO.O)
FY 78  ATI  FY  79 C.  E,  FY bQ
      20.0           7.0           2.0
258.0
                    13.5
                  362.2
 2.0
55.a
                                     FY 80  CUM
                                           16,0

                                           16.0
    C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
      OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.
    ACTIVITIES

    Region IV will receive two positions  to permit the complete review of sec-
    tion 24(c) special local needs  registrations.  All section 5(f)  state plans
    will be developed and operative.   Guidance will be provided to States con-
    cerning adequacy of legal authorities to conduct section 24(c) activities.
    Section 5, IB and 24(c) documents  will be reviewed and some follow-up
    evaluation will be initiated.
    IMPACT

    - Funding  this level will allow Region IV to carry out its  full section
   ,24(c) responsibility as delegated.   States will be provided with  important
    information to facilitate their activities.

    - Not funding this level will  impact on headquarters,  which will  not have
    the regional support for the section 5 and 18 programs.   The states within
    Region  IV  will also be impacted since the Region will  not be able to
    provide needed guidance relative to  state section 24(c)  activities.
  EPA Form 2410-11 (8-78)

-------
















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-------
                     ENVIRONMENTAL PROTECTION AGENCY
FORM 1: DECISION UNIT OVERVIEW
  A)  DECISION UNIT TITLE (AND CODE)
    '  REGISTRATION  (E220)
HQ  OTS     MEDIA-Pesticides

REG.        APPRO:A&C
  B) LONG RANGE GOALS & MAJOR OBJECTIVES
    Process and review applications for registration and amendments to current
    registrations, as mandated by the Federal Insecticide,  Fungicide and
    Rodenticide Act to allow new pesticide products into the market, while
    protecting health and the environment.

    Reregister pesticide products that meet the requirements of generic
    standards.

    Classify for general or restricted use, through the use of regulations,
    certain pesticidal uses which,  if left unclassified, could cause an adverse
    effect to man or to the environment.   Registration activity is a result  of
    Operation Division developing and publishing the classification regulation.

    Maintain the registration records, develop and maintain protocols and  data
    guidelines, maintain registration standards and process changes to
    registration records.

    In carrying out these objectives, registration goals are:   (1) to reduce
    the time required to reach a registration decision;  (2) to reduce the
    overall time spent in processing routine applications;  and (3) to
    reregister and classify presentlv registered products in a timely manner.
   Cl  FY 78 ACCOMPLISHMENTS

    The number of actions processed is shown on Form 4.

    Proposed guidelines on data requirements to support  registration were
    published for product chemistry, environmental fate,  environmental safety,
    and human safety evaluations.

    Site/pest coding,  an important  asset  for the substitute chemical program
    and the RPAR process,  was begun on product labels presently on file.   It is
    anticipated that Site/Pest  coding will be completed  in  the  first quarter of
    FY 79.

    Regulations were prepared for  conditional registrations in  anticipation of
    the passage of the  legislative  amendments.
                                  i
    Scientific  evaluation procedures were  reviewed and,  in  some cases,  changed
    in order to achieve greater productivity.

    An automated  registration tracking system was  developed;  it has  not yet
    been implemented.
                                                                   0283
EPA Fern. 2410-10 (B-78)

-------
                     ENVIRONMENTAL PROTECTION AGENCY
FORM 1:  DECISION UNIT OVERVIEW
  A)  DECISION UNIT TITLE (AND CODE)
     REGISTRATION (E220)
HQ  OTS     MEDIAiPesticides

REG.        APPROA&C
  D)  FY 79 PROGRAM DESCRIPTION
    The number of actions expected to be processed  is  shown  on Form 4.

    Conditional registration of pesticide products  will  begin.  This mechanism
    will cause the  registration process  to experience  a  sharp influx of me-too
    registrations and amendments.   It is expected that near  the end of the
    second quarter  of FY 79 incoming  applications for  me-too products will
    exceed 250 per  month and amendments  500 per month  — more than twice  the
    1978 rate.

    In FY 79, the registration program plans  to cease  classification of
    pesticidal uses by regulation  and replace it with  reregistration.  However,
    it is planned that an additional  5300 products  will  be classified before
    this activity ceases.

    The registration program will  begin  planning to utilize  generic standards
    to reregister products.  The number  of reregistrations will be minimal,
    however, as only the prototype generic standards will be available in FY
    79.

    Activity will continue on registration data guidelines publication, on
    increasing the  efficiency of the  registration review process, and on
    reduction of overall registration decision making  time.
       0284
EPA Fern 24)0.10 (ft.78)

-------
                   ENVIRONMENTAL  PROTECTION AGENCY

FORM  2i DECISION  UNIT LEVEL ANALVSI5

A.  DECISION  UNIT  TITLE  AND CODE         HQ       MŁUIM PEST
E220  REGISTRATION                                  APPRO| A  &  C
B,  RESOURCE  SUMMARY       FY 78  ACT FY  79 C.  E,  FY  80 INCR   FY  80 CUM
         POSITIONS   PFT         208.0        227,0        170,0        170,0
 LEVEL              OPFT           2.0          u.O         11.0         11.0
01  OF  Ob             FTE                      19U.9        214.2        214.2
    BUDGET  AUTH.  (000.0)     7,772.0      8,47n.6      5,761.2     5,761.2
   C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
     OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.
  ACTIVITIES

  Process to completion 2800 administrative amendment applications  (including
  name changes, labeling and other minor changes to the registration files,
  and cancellations of products  on file).  Process to completion  1400 tech-
  nical amendment applications (including addition of new sites,  pests, modes
  of application, application rates, tank mixes, and other labeling changes
  which require data).   Begin the review process for 22 new chemical appli-
  cations and reach a final regulatory decision (acceptance or denial) on 22
  of the total number of new chemical  applications pending before the
  Agency.  Process to completion 1900  routine applications for registration
  (these will be  handled under conditional registration provisions), and
  24,000 supplemental registrations.   Reregister 1350 presently registered
  products based  on completed generic  standards and using "call-in" packages
  (i.e. instructions to affected registrants regarding reregistration).

  When FIFRA was  amended in 1972, some 7400 intrastate products filed an
  intent to Federally register.  These products were to be called-in at some
  future time to  be registered.  Instead of waiting for completed generic
  s.tandards, 5400 of these products will be called-in for conditional regis-
  tration.

  Maintain coordination of data  storage, micrographics, tracking  systems,
  site/pest coding, and Federal  Register publication associated with the
  above listed activities and associated data compensation and trade secret
  provisions of FIFRA.

  Provide administrative and technical assistance for enforcement sampling
  cases and provide expert witnesses in adjudicatory hearings  supporting
  enforcement and regional activities  in coordination with the Office of
  Enforcement.

  Provide administrative and technical personnel to meet with  registrants,
  relay information to  interested parties, and coordinate outgoing  cor-
  respondence on  registration activities.   Regions normally handle  registrant
  inquiries concerning  the registration process, but specific  technical and
  administrative  questions must  be answered from headquarters.
EPA =orm 2410.J1 (8-78)

-------
                     ENVIRONMENTAL PROTECTION AGENCY

FORM 2:  DECISION UNIT LEVEL ANALYSIS
  A.  DECISION UNIT TITLE (AND CODE>

  . REGISTRATION (E220)
                    HO OTS       MEDIA:Pesticides
                    REG.         APPRO:A&C
  B.  RESOURCE SUMMARY
FY 7Ł ACTUAL  FY 79 C. EST.  FY 80 INCR.
FY 80 CUM.
LEVEL
1 OF 6

POSITIONS PFT
OPFT
FTE
BUDGET AUTH. (000.0)
















  C.  DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
     OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.
  The 1972 amendments to FIFRA required the Agency to publish "...guidelines
  specifying the kinds of information which will be required to support
  registration...."  This includes ongoing development and testing of new
  test methodologies by EPA laboratories.   Approved methodologies will be
  added to the guidelines.

  Maintain registration records for actions related to the above workload and
  to already registered products.   For example,  file records will be
  maintained on PCB activities, and new data will be incorporated into the
  RPAR and generic standards data  files.
 ,IMPACT

  Funding this level permits the agency to process three quarters of its anti-
  cipated registration workload.  Most of the resources will be used in non-
  scientific registration areas; -that is, emphasis will be placed on han-
  dling most applications for registration under conditional registration (no
  scientific review) and processing to a decision other amendments to exist-
  ing registrations.  But because  new chemicals and many technical amendments
  necessitate scientific review, continued delays would be experienced in
  obtaining new chemical registrations and acceptance of technical
  amendments.

  At this level of funding, it is  anticipated that pressure groups and indus-
  try would continually complain about the long time required for the Agency
  to reach a decision concerning registration of new chemicals and new uses.
  There would be approximately 130 technical amendments and new chemical
  applications pending in the registration process, to reach a registration
  decision on these pending applications will require some 350 scientific
  reviews.
EPA Form 2410-11 (8-78)

-------
                      ENVIRONMENTAL PROTECTION AGENCY

FORM 2:  DECISION UNIT LEVEL ANALYSIS
  A.  DECISION UNIT TITLE (AND CODE)
    REGISTRATION (E220)
                   HQ OTS     MEDIA:Pesticides

                   REG.        APPRO A&C
  B.  RESOURCE SUMMARY
FY 78 ACTUAL  FY 79 C, EST.   FY 80 INCR.
FY 80 CUM.
LEVEL
-i-OF-1-
POSITIONS PFT
OPFT
FTE
BUDGET AUTH. (000.0)
















  C.  DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
     OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.
  Because of the scientific review constraints on the registration process
  for new chemicals and technical amendments, decisions concerning these
  applications are taking more than 11 months to make.  It has been estimated
  that every growing season a chemical misses, because of delays in obtaining
  registration, costs the affected companies between $1.5 and $2.0 million.
  Funding only at this level would not reduce the time to make a registration
  decision.

  Since registration activities are mandated by law and influenced by the
  growth of the agricultural-chemical industry, funding at a lower level
  would result in greater delays in registration decisions and increased
  pressure on EPA to speed the processing time by lowering its standards.
  This would result in an adverse affect on public health and the
  environment.
                                                                   J2E 7
EPA Form 2410-11 (8-78)

-------
                  ENVIRONMENTAL PROTECTION  AGENCY

FORM  2: DECISION UNIT LEVEL.  ANALYSIS
 ••••••'•"'""""••••'•"•'•'•"••"•"'•"••"•••••^•••••••••••••"••••••••••••••(••••w
A, DECISION  UNIT TITLE AND  CODE         HQ       MEDJAj PEST
E220  REGISTRATION                                  APPRO| A  & C
"•••*"•""'•••»••••"«••••'•'•«••••» •••••»••••••••»••••••••»•»•••»••••»••••»
B. RESOURCE  SUMMARY       FY  78 ACT  FY 79  C.  E.   FY PQ INCR    FY 80 CUM
         POSITIONS  PFT        208,0         237,0         34,0        204.0
 LEVEL              OPFT          2.0          11,0          2.0         13,0
02 OF  00            FTE                      194,9         19,e        23«,0
   BUDGET AUTH,  (000.0)     7,772.0      8,470.6      1,152,2      6,913.4
   C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
     OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.
   ACTIVITIES

   Process  to completion 500 administrative amendments and 300  technical
   amendments.

   Begin the review process of  5 new chemicals and reach a final  registration
   decision (acceptance or denial) on 5 of the total number of  new  chemicals
   pending  in the registration  process.

   Process  to completion 400 routine applications for registration  now handled
   under conditional registration provisions.

   Develop  and mail 50 reregistration call-in packages and reregister 350
   presently registered products using completed generic standards.

   Call-in  1000 "intrastate" products for registration.
  I
   Provide  records management,  data  processing, and other activites  associated
   with the above workload.
   IMPACT
   Funding this level would  allow  the Agency to process 90%  of  the anticipated
   incoming registration workload  assuming that registrations issued will rely
   mainly on conditional registration provisions.  No reduction will be made
   in  the greater than 11 months delay before making a decision on acceptance
   or  denial of new chemical registrations and technical amendment
   applications.

   Not funding this level would require the Agency to cut short the present
   scientific review process for new chemicals and technical amendments,
   either by a change in the review format or by a reduction in the review
   quality.  This would mean that  data would have to be rereviewed prior to
   incorporation into the generic  standards process.  Documentation of
   registration decisions would become more resource intensive  because of the
   reduction in the quality  of scientific reviews.
         0263
 EPA Form 24)0-11 (6-78)

-------
                  ENVIRONMENTAL  PROTECTION AGENCY
FORM  2? DECISION  UNIT LEVEL ANALYSIS
A. DECISION  UNIT  TITLE  AND CODE          HQ       MEDIAf PŁST
E220  REGISTRATION                                   APPRD| A  & C
• • V •*•)•••>••• • • IB • IB M • • M W tt • • M M ^ W M ^ M M ^ ^ ^ ^ ^ ^^^^^^^^ M. •• ^ ^ ^ ^ ^ • ^ _  K. ^ ^     —
'"^^"'"'""•^""••^™r^^^^^^^^^^^^^^^^^^^^^^^«»^»i»^^«*^W»^f>^^^^^W^li«Hp»W^f»«^IP»»»W»»l»»
8. RESOURCE  SUMMARY       FY 78  ACT FY  79 C.  E.  FY 80 INCR    FY 80 CUM
         POSITIONS   PFT        208.0        327.0         23.0        227,0
 LEVEL              OPFT           2.0          11. 0           1.0         1U.O
03 OF  Ob             FTE                      10t|.«?         13.0        2«7.0
   BUDGET AUTH, (000.0)     7,772.0      8,470.6        7*8.2      7,fe81.6
   C.  DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
      OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.
   ACTIVITIES

   Process to completion  400  administrative amendments and 200 technical
   amendments.

   Begin the review process for 5 new chemicals and reach a final  registration
   decision (acceptance or denial) on 5 of the total number of new chemicals
   pending before the  Agency.

   Process to completion  300  routine applications for registration,  now
   handled under  conditional  registration provisions.

   Develop and mail 25 reregistration call-in packages and reregister 350
   presently registered products based on completed generic standards.

   Call-in 1000 "intrastate"  products for registration.
  !
   Provide records  management, data processing and other activities  associated
   with the above activities.
   IMPACT
   Funding  at  this  level would put in place the resources necessary  to  process
   100% of  the anticipated registration workload, assuming that  the  majority
   of registrations issued rely on the conditional registration  provisions of
   the FIFRA,  as  amended.  New chemical and technical amendment  applications
   would be given an in-depth review for later incorporation into  generic
   standards.

   The number  of  new chemical and technical amendment submissions  awaiting
   scientific  reviews would drop to approximately 100,  and the total number of
   pending  scientific reviews would be reduced to around 260.  The overall
   effect of this reduction upon the backlog would be to reduce  the  time
   needed to reach a registration decision from over 11 months to  8 months.

   Not funding this increment would mean the Agency would have a backlog of
   130 applications for new chemicals and technical amendments awaiting
   registration decisions.  As a result, pressures would be generated to
   shortcut  registration reviews, which would in turn cause increased activity
   in Section  24(c) registrations and Section 18 exemptions.  The  net effect
   would thus  be  to tax the scientific support available for  registration,
   since these extra resources would be obtained by removing  them  from  the
   normal registration activities.
 EPA Form 2410>11 (8-78)

-------
FORM
                   ENVIRONMENTAL  PROTECTION AGENCY

         DECISION  UNIT  LEVEL ANALYSIS
A,  DECISION  UNIT  TITLE  AND CODE
E220  REGISTRATION
                                             HQ
                         MEDIA;  PEST
                         APPRDi  A  i C
B,  RESOURCE  SUMMARY
         POSITIONS   PFT
 LEVEL              OPFT
04  OF  06             FTE
    BUDGET  AUTH.  (000.0)
FY 78  ACT  FY
     208,0
       z.o

  7,772.0
                                            79 C,  E.
                                               237.0
                                                n.o
                                               194.9
                                             8,470.6
FY
 INCH
 17.0
   1.0
 15.5
567. B
FY  60 CUM
     244,0
      15.0
     262.5
  8,249.4
   C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
     OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.
   ACTIVITIES

   Reduce  registration backlog of pending new chemicals and technical
   amendments to 60.

   Reduce  response time on applications for registration of new chemicals or
   technical amendments from 8  to 7  months.

   Process registrations and amendments more rapidly,  especially
   reregistrations.

   Reduce  scientific reviews backlog on pending applications by 45 reviews.
   IMPACT
   This  level of funding would  impact mainly on the backlog  of new chemical
   and technical amendment applications awaiting a registration decision.  The
   backlog of these applications would be reduced to around  60 applications
   and the number of scientific reviews backlogged would  b~e  reduced to around
   215.  Decision making time  would be reduced to around 7 months after an
   application is received instead of the 11 months projected at level one.

   Reregistration processing  time would be decreased.   This  will mean a
   shorter time interval for  companies to receive decisions  on reregistration
   or registration of products which fall within the scope of a generic
   standard.

   Not funding this level would mean that science evaluations of new chemicals
   or technical amendments would be done at a rate which  would maintain a
   backlog well into FY 1982  or perhaps longer.   With  a continuous backlog of
   applications requiring scientific review, it  is unlikely  that the Agency
   will  be able to make timely registration decisions.

   Funding at a lower level would also have a negative  effect on the
   reregistration and the intrastate registration process.
          U27U
 EPA Form 2410-11 (8-78)

-------
















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                     ENVIRONMENTAL PROTECTION AGENCY

FORM 1:  DECISION UNIT OVERVIEW
  A)  DECISION UNIT TITLE (AND CODE)                    HO OTS      MEDIA'Pesticides

     Tolerances(E  230)                              REG.         APPRO:  A  &  C
  B)  LONG RANGE GOALS & MAJOR OBJECTIVES
           The objective  of  this program is to protect public health by setting
     limits on the  level  of  pesticide residues on food and feed crops.
     Pursuant  to the  provisions of the Federal, Food, Drug, and Cosmetic Act
     (FFDCA),  a major objective is to process all incoming tolerance petitions
     within 90 days and to significantly reduce or eliminate the backlog of
     actions while  assuring  a high level of responsiveness to tolerance
     petition  inquiries.  The FY 79 and FY 80 funding levels assure adequate
     responsiveness and prevent an increase in the backlog.
  C)  FY 78 ACCOMPLISHMENTS
          One  hundred thirty five new petitions (including 15 new chemicals),
     125  amendments and 60 inert ingredient requests were reviewed to
     establish residue levels that will protect human health.  Approximately
     450  telephone  requests  and 300 written requests for tolerance infor-
     mation were processed with written response time averaging less than two
     weeks.  The 15 petitions for new chemicals included tolerance requests
     for  two chemicals on cotton to control the cotton bollworm, for which
     there is  presently no means of control.  These chemicals are permethrin,
     a  new synthetic  pyrethrin, and Bolstar 6, a new phosphorodithioate.
     These 15  petitions also included a request for tolerances for Goal 6E, a
     new  herbicide  to control weeds in corn and soybeans.
  D)  FY 79 PROGRAM DESCRIPTION

         Review all incoming tolerance actions to establish residue levels
    that will protect human health.  Provide written replies to tolerance
    petitions within two weeks.  Type F (raw agricultural commodity) and
    H  (food additive) tolerance petitions will be processed within 105 days,
    which is more than the legal requirement of 90 days,  but necessary
    because of resource constraints.

         Process 120 new petitions (including 15 new chemicals),  100 amend-
    ments and 60 inert ingredient requests.   This processing shall include
    administrative handling, coordination of data review, review  of data,
    risk-benefit analysis and preparation of Federal Register Notices.

         Answer 300 written and 450 telephone inquiries including both
    specific Congressional inquiries and responses to general correspondence
    regarding tolerances, new chemicals, inert clearance  requirements,
    procedures and other requested information.   Replies  to inquiries'on
    tolerances will average two weeks turnaround time.

       J27*
EPA Form 2410-10 (8-78)

-------
                   ENVIRONMENTAL  PROTECTION  AGENCY

FORM  Ł,• DECISION UNIT  LEVEL  ANALYSIS

A.  DECISION UNIT TITLE  AND CODE         HG       HEDIAf  PEST
E330  TOLERANCES                                     APPRU|  A  * C
  • ^ ^ WWWW»WW«l»  •'••WWWM»MMW*ft4HIVW*WWWWMlVilWWWMMWJWVWWW*Wl*t»WM»WW**»*k<*gpWI»5             FTE                        66.6          54.1         5«.l
    BUDGET  AUTH.  (000,05     1,037.0      1,319.6        989.7        969.7
   C.  DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
      OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.

      Activities

      Process  90 new petitions (new petitions include 15 new chemicals),  90
      amendments, and 40 inert ingredient requests.  Processing includes
      administrative handling, coordination of data review, review of data,
      risk-benefit analyses and preparation of the Federal Register notices.

      Handling actions in order of receipt would yield an average  turnaround of
      160 days which is almost twice the  legal requirement of 90 days under
      Section  408 of the Federal Food,  Drug, and Cosmetic Act for  type  F  (raw
      agricultural commodity) and type  H  (food additives) petitions.

      Answer specific Congressional inquiries and respond to general corres-
      pondence regarding tolerances, new  chemicals, inert clearance requirements.
      procedures, and other requested information.  Total numbers  of inquiries
      expected to be 300 written and 450  by telephone.  Average turnaround
      time will be one month for written  replies.
      Impact

      Funding this level would add 80 new actions to the 100 action backlog
      carried over from the previous year.  Some regulation of pesticide
      residues for public health protection would be provided.

      Not  funding this level would be funding grossly below legal  requirements.
      The  Agency would constantly be bombarded with complaints from petitioners
      and  be subjected to Congressional pressures.  Operating at this  level
      would actually waste resources in dealing with an unusual demand to
      explain delays to Congressional and industry representatives.
                                                                     J21 5
  EPA Form 2410-11 (8-78)

-------
                  ENVIRONMENTAL  PROTECTION AGENCY

FORM  2» DECISION  UNIT LEVEL ANALYSIS
»-»-~~-~ — *»*-*»~m~m»»m~mmmmmmi,m»m*mmmmmmmmmmmm0mmmmmmmmmmmmmmmmmmm
A.  DECISION  UNIT  TITLE  AND CODE          HO       MECIAj  REST
E?30  TOLERANCES                                     APPROj  A & C
 ^ V " V ^ V W V W • • |p ^ V • •? V 9 •• V W •• • V V V V • V W V W • M Ik •• • 49 • •• •• W ^ W BP • •> ^ W ^ • ^ ^ ^ ^  M ^ ^ ^^ ^   ^
B,  RESOURCE  SUMMARY      FY 78 ACT FY 79 c, E.   FY BO  INCR    FY so cu*
         POSITIONS   PFT          68.0         51,0           8.0          5J.O
 LEVEL             OPFT                        5.0                         50
02  OF 05             FTE                       66.6           a.o          58.i
    BUDGET AUTH. (000.0)     1»037.0      1,519,6         197.9      1,1*7.6

   C.  DESCRIBE  THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
      OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.

     ACTIVITIES

     Process 25 new petitions,  25 amendments and 10 inert ingredient requests.
     Processing includes administrative  handling, coordination of data review,
     review of data, risk-benefit analyses and preparation of the Federal
     Register  notice.  Reduce  the average  turnaround time for F  and H
     petitions to 120 days.  Reduce  average turnaround  time to 3 weeks for
     written replies to tolerance inquires.

     IMPACT

     Funding this level will permit  the  Agency to process 90% of  all incoming
     tolerance petitions adding 30 new  actions to the  backlog carried over
     from the  previous fiscal  year.  Also, a quicker response will be provided
     to tolerance inquiries, with a  reduction  from 4 to 3 weeks  in average
     response  time on written  replies.

     Not funding this level would result in performance grossly below legal
     requirements; and because  of the backlog  there would be many
     Congressional inquires and petitioner compliants.   An average of four
     weeks would be required for written replies to tolerance inquires.
         027
 EPA Form 2410-11 (8-78)

-------
                  ENVIRONMENTAL  PROTECTION AGENCY
FORM  2s DECISION  UNJT LEVEL ANALYSIS
A,  DECISION  UNIT
E230  TOLERANCES
TITLE  AND COPE
HO
     Aj  PEST
APPRO!  A & C
B,  RESOURCE  SUMMARY
         POSITIONS   PFT
 LEVEL              OPFT
03  OF  05             FTE
    BUDGET  AUTH.  (OCO.O)
         FY  78 ACT  FY 79 C.  E.
               68.0          51,0
                              5.0
                             66.6
            1,037,0      1,319.6
          FY
                  6.0
                  1.0
                  7.5
                132.0
                FY  80  CUM
                      57,0
                       6.0
                      65.6
                  1,319.6
  C.  DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
     OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.

    ACTIVITIES

    Process  20 new  petitions, 10 amendments and 10 inert ingredient requests.
    Processing includes administrative  handling, coordination  of data review,
    review of data, risk-benefit analyses  and preparation of the Federal
    Register notice.  Reduce the average turnaround time for F and H
    petitions to 100 days.  Reduce  average turnaround time to  2 weeks for
    written  replies to tolerance inquiries.

    IMPACT
    Funding  this level will permit  the Agency to process  all  incoming
    tolerance  petitions (100% of this year's incoming workload), with no
    change  in  the number of backlog  items carried over from the previous
    fiscal year.  (100 action backlog remains).   Also a quicker response will
    be provided to tolerance inquires, with a reduction from  3 to 2 weeks in
    the average response time on written replies.

    Not funding this level would result in a further increase in turnaround
    time above the 90 day legal  requirement for F and H petitions.  This
    increased  time plus an increase  in the backlog would  result in congres-
    sional inquiries and petitioner  complaints.
                                                                  027 7
EPA Form 2410-11 (8-78)

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                  ENVIRONMENTAL PROTECTION AGENCY
FORM 1:  DECISION UNIT OVERVIEW
 A) DECISION UNIT TITLE (AND CODE)

    PESTICIDE USE MANAGEMENT    (E240 )
                                       HQ OTS      WEDIA:pESTICIDES
                                       REG.        APPRO: A & C
  B)
                                                           to
LONG RANGE GOALS & MAJOR OBJECTIVES
    Provide the Administrator  with  regulatory options
    cancellation through certification  programs  for
    pesticide applicators which  allow them  to apply
    restricted use pesticides.
    Conduct classification  programs, in which certain
    pesticide uses are restricted for use only by
    certified applicators.
    Classify sufficient pesticide uses  to provide  a base
    of restricted use pesticides for certified applicators
    taking into consideration  IPM alternatives.
    Ensure States are programmatically,  legally  and
    able to meet the changing  technological
    recertification.
    Grant full approval of  all State certification  plans
    transfer existing Federal  programs  in Colorado  and
    Nebraska to the States.
    Maintain a high level of communications with other  Agency
    programs,  outside special  interest  groups  and  the States
    to ensure  maximum cross-fertilization in
    processes  and to maintain  regulatory
                                                         fiscally
                                                 requirements for

                                                              and
                                                  regulatory
                                             consistency.
  C)
                                  use 23 active ingredients
 U26J
FY 78 ACCOMPLISHMENTS
    Fully approved an additional 30 State certification
    plans;  approved 1 Federal agency plan; implemented 2
    Federal certification programs; initiated development
    Indian  certification plans in eight Regions.
    Let  contract  to evaluate effectiveness of certification
    program.
    Classified  for restricted
    affecting  3,300 uses.
    Trained to  date 8&Z  (282,494) of commercial and 79%
    (1,341,000) of private applicators for initial
    certification.
    Developed,  published and distributed applicator
    training manuals  on  Agricultural Plant,  Regulatory,
    Right-of-Way,  Antimicrobial  and Wood Preservation
    categories.
    Developed and  distributed "Pesticide Fire and Spill"
    training program  for firefighters  and "Farm Worker
    Protection" program  for  health  personnel.
    Maintained  liaison with  States  for their  input to
    regulatory  decision  process.
    Began development of  a formal evaluation  model for the
    applicator  certification and  training program.
    Completed a survey of  State  needs  for certification and
    training fund-trio.	___	
                                                               of
EPA Form 2410-10 (8*78)

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                  ENVIRONMENTAL PROTECTION AGENCY
FORM 1: DECISION UNIT OVERVIEW
  A) DECISION UNIT TITLE (AND CODE)

    PESTICIDE USE MANAGEMENT   (E240)
HQ OTS      MEDIA:pESTICIDES

REG.        APPRO: A 6, C
  D) FY 79 PROGRAM DESCRIPTION

        Provide  legal  and grant assistance  to  regions for the
        conduct  of  State and Federal certification programs.
        Monitor  and  review certification programs  and provide
        technical assistance to upgrade those  programs.
        Continue development of Indian certification  programs.
        Maintain liaison with States for their  input  to
        regulatory  decisions.
        Classify for restricted use the remaining  38  active
        ingredients  from initial set of 61  begun in  1978  and an
        additional  10  granular formulations affecting 1,200 uses.
        Integrate IPM  into regulatory processes and  disseminate
        information, in  accordance with Section 4(c).
        Expand evaluation  of the certification  and training program
        for^private  applicators to enough States (5  or 6)  to draw
        national inferences.
                                                         0261
EPA Form 2410*10 (8-78)

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                 ENVIRONMENTAL PROTECTION AGENCY

     21 DECISION UNIT  LEVEL ANALYSIS
A. DECISION UNfT  TITLE  AND  CODE
E2«0 PESTICIDES USE  MANAGEMENT
              HQ
            M PEST
        APPROf *  & C
B. RESOURCE SUMMARY
        POSITIONS  PFT
 LEVEL            OPFT
01 OF 07           PTE
   BUDGET AUTH.  (000.0)
FY 78 ACT FY 79
     •^ *  f,
     21,0
      2.0
       ,0
  C. E.
   16.0
    t.O
   19.9
5*131.2
FY
BO INCR-
   12,0
    l.o
   15.a
1/957.0
FY 80 CUM
     12.0
      1.0
     15. U
  1,957.0
   C.  DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
      OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.
   Activities

        Certification and Training  - Provide basic  legislative
   review and regulation development  assistance to States and
   Indian Tribes (through regions, where  possible) as well as
   other  Federal Agencies for  certification programs.  Perform
   minimal review of submitted plans  for  conformity to
   standards before Administrator's approval.   Monitor
   operations under approved State plans  and  provide minimum
   Federal assistance in States  without plans.   Grants would be
   allocated as follows: States  without plans  - $187. 5K, Indian
   plans  - $187. 5K, States with  approved  plans  - $1169. 6K.
        IPM - No activity.
        Intergovernmental Public  Liaison - Provide  overview of
   grant  to American Association of Pest  Control Officials
   (AAPCO).  The purpose of the  grant is  to provide
   recommendations  to EPA on FIFRA regulations  and
   implementation issues; issue  OPP/OTS weekly  report within
   EPA  and to the States and public.  Respond  to inquiries from
   States, regions, Federal agencies  and  associations.
        Other Regulatory Activities -  Coordinate and finalize
   promulgation of Section 5(f)  regulations for State issuance
   of Experimental Use Permits.
        Restricted Use Classification  - No activity.
        Training Material - Maintain  repository  for and exchange
   certification and training  materials with  State and Federal
   Agencies.

   Impact

   Funding this level would provide minimum Federal support to
   States, Indian Tribes and regions  for  certification and
   training programs.  It would  also  provide maintenance of
   national program consistency  and ensures limited public
   participation in OPP decision processes.

   Not  funding this level would  result in States discontinuing
   their  cert if ication/ training  programs  with  consequent
   reversion to Federal operation.

    NOTE:   FY 78 Base Budget Authority is $2,577K. A lower figure is shown
           because $1020K was transferred to regions for State certification.
     021
  EPA Form 2410-11 (8-78)

-------
                 ENVIRONMENTAL PROTECTION AGENCY

FORM ?: DECISION  UNIT  LEVEL  ANALYSIS

A, DECISION UNIT  TITLE AND CODE        HQ      MEDIAf  PEST
     PESTICIDES  USE  MANAGEMENT                 APPRO|  A  &  C
B, RESOURCE SUMMARY       FY  78 ACT FY 79 C. E.  FY  *o  INCR    FY 80 CUM
        POSITIONS  PFT         21,0         u.o          2,0         i«,o
 LEVEL             OPFT          2.0         1.0                      1,0
02 OF 07           FTE                      19,9          1,0         16, «
   BUDGET AUTH,  tOOO.O)     4,43U.t)     3,131.2       391.4      2,308.4
    C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
      OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.
    Ac t ivi t ies

        Certification and Training  -
            States with  plans  -  Evaluate overall program through
    monitoring of enforcement  actions  and P1MS accident reports
    involving certified  applicators.   Ensure that proposed State
    laws, regulations and plan amendments are adequate to carry
    out the program.  Review  J State  recer t if ication programs.
            States without  Plans -  Evaluate effectiveness of
    regional office implementation  of  programs in Colorado and
    Nebraska.  Develop and  implement  programmatic and political
    strategy to overcome obstacles  to  State assumption of
    pr ogr ams .
            Federal Agency  Plans -  Assist Federal agencies in
    developing certification  programs.   Coordinate review of
    certification plans  with  EPA officials, the public and
    special interest groups.   Develop  and implement program to
    monitor Federal agency  plans.   Additonal grants would be
    allocated as follows:   States  without  plans - $37. 5K,
    Indian Plans - $37. 5K,  States  with approved plans -
    $141.8K.
        IPM - Coordinate IPM  information dissemination function
    and oversight to State  plan  modification per Section 4(c).
        Intergovernmental/Public Liaison - No change.
        Other Regulatory Activities -  Coordinate pesticide
    disposal activities  with  Office of  Solid Waste; develop
    criteria for label statements,  training program information,
    and disposal policy  and strategy  for EPA; develop and
    implement 24(c) regulations  per 1978 FIFRA Amendments.
        Rescricted Use Classification  - Classify 1200 restricted
    uses for 15 active ingredients.
        Training Materials  -  Develop  and disseminate annotated
    bibliography on available  training  materials.  Coordinate
    training materials development  with States, industry, and
    USDA.
    NOTE:   FY 78 Base Budget Authority is $2,577K.  A lower figure is shown
           because $1020K was transferred to regions for State certification.
  EPA Form 2410-11 (8-78)

-------
                 ENVIRONMENTAL PROTECTION AGENCY

FORK 21 DECISION  UNIT  LEVEL ANALYSIS
A. DECISION  UNIT  TITLE  AND CODE        HQ       MEDIAi  PEST
E2«0 PESTICIDES  USE  MANAGEMENT                  APPROi  A R. C
******'***— i*****l»*WW»»«»M«ll»««»»«i«l»»^«*»    • • M        ^
B. RESOURCE  SUMMARY       FY 76 ACT FY 79 C. E,   FY  80  INCR   FY 80 CUM
        POSITIONS  PFT         21,0         ie.0          2.0        i6,o
 LEVEL             OPFT          2.0          i.o                      j.o
03 OF 07           FTE                      19.9          1,0        17.4
   BUDGET AUTH.  (000.0)     4,454.0     3,131.2        260.9     2,609.3

   C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
     OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.

   Activities

       Certification and  Training - in States with  plans
   evaluate  overall  program through monitoring  of enforcement
   actions  and PIMS  accident reports involving  certified
   applicators.  Ensure  that proposed State laws, regulations
   and plan  amendments  are adequate to carry out  the program.
   Review 3  State  recer tif icat ion programs.
            In  States without Plans evaluate effectiveness of
   regional  office implementation of programs in  Colorado and
   Nebraska.   Develop and implement programmatic  and political
   strategy  to overcome  obstacles to State assumption  of
   programs .
            Federal Agency Plans - assist Federal  agencies in
   developing  certification programs.  Coordinate review  of
   certification plans  with EPA officials, the  public  and
   special  interest  groups.   Develop and implement  program to
   monitor  Federal agency plans.   Additonal grants  would  be
   allocated  as  follows:   States  without   plans - $37. 5K,
   Indian Plans  -  $37. 5K,  States with approved  plans  -
   $141. 8K.
            IPM - coordinate IPM information dissemination
   function  and  oversight to State plan modification per
   Section  4(c).
            Intergovernmental/Public Liaison - No  change.
            Other Regulatory Activities - Coordinate pesticide
   disposal  activities  with Office of Solid Waste;  develop
   criteria  for  label statements, training program  information,
   and  disposal  policy  and strategy for EPA; develop and
   implement  24(c) regulations per 1978 FIFRA Amendments.
            Restricted Use Classification - Classify 1200
   restricted  uses  for  15 active ingredients.
            Training  Materials - Develop and disseminate
   annotated  bibliography on available training  materials.
   Coordinate  training  materials  development with States,
   industry,  and USDA.
    NOTE:  FY 78 Base Budget Authority is $2,577K.  A lower figure is shown
          because $1020K was transferred to regions for State certification.
 EPA Form 2410-11 (8-78)

-------
                   ENVIRONMENTAL PROTECTION AGENCY
FORM 2: DECISION UNIT LEVEL ANALYSIS
  A. DECISION UNIT TITLE (AND CODE)

    PESTICIDE USE MANAGEMENT  (E240).
                 HQ OTS      MEDIA:PESTICIDES
                 REG.        APPRO: A & C
  B. RESOURCE SUMMARY
FY 78 ACTUAL FY 79 C. EST.  FY 80 INCR.
FY80CUM.
LEVEL
3 7
continued
POSITIONS PFT
OPFT
, FTE
BUDGET AUTH. (000.0)
















  C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
    OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.

    Impact

    Funding this  level would permit some evaluation  of  the
    effectiveness  of  certification  programs.  This level
    provides for  IPM  information  dissemination to meet  Section
    4(c) requirements.

    Not funding  this  level would  eliminate in-house  evaluation
    of certification  and training  operations.  It could also
    force cancellation of some  pesticide uses which  could
    otherwise  be  preserved as restricted uses thus limiting
    their availability to certified applicators  only.   Thus the
    Administrator  would be deprived of  a regulatory  option.
EPA Form 2410-11 (8-78)

-------


















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-------
                  ENVIRONMENTAL PROTECTION AGENCY
FORM 1:  DECISION UNIT OVERVIEW
 A} DECISION UNIT TITLE (AND CODE)

    PESTICIDE USE MANAGEMENT  (E240)
HO    EDIA:PESTICIDES

REG.X  'PRO: A & C
  B) LONG RANGE GOALS & MAJOR OBJECTIVES
          Implement Federal Agency  certification  ciicators,
          monitor and upgrade State applicator  ceration
          programs, and conduct  Federal  certificatrograms
          in Colorado and Nebraska  and with  Federancies.
          Develop certification  and training  progr^r  Indian
          Nations.
          Assist States in upgrading applicator ce;ation and
          training programs and  develop  recertific
          programs to meet original plans  and prog»ectations
          Monitor implementation performance.
          Act as the Agency's official representatid  liaison
          for the public on all  issues connected  w;sticides
          within the geographic  area covered  by thfon.
          Audit current State operations and  assurer use of
          grant funds.
          Verify pesticide incidents to  ensure  useita
          in headquarters special pesticides  reviev
          regulatory decisions and  establish  PIMS Cative
          agreements with States.   Participate  withes in
          workshops to better inform health  emergeifeponse
          personnel.
          Integrate IPM into regulatory  actions (e.»ction 18
          emergency exemptions,  registrations  and rafale
          presumptions) when technically appr opriatrovide
          State applicator training programs  with iition on
          IPM techniques.  Develop  a data  base  on e.veness
          and environmental advantages of  IPM.
          Establish, support and strengthen  Federal.
          cooperation in the implementation  of  FIFR
  C)  FY 78 ACCOMPLISHMENTS
          Gained full approval of 30 additional  certion
          plans.
          Implemented Federal certification  program&lorado
          and Nebraska.
          Initiated Indian certification program thi
          participation in 8 regional meetings.
          Investigated incidents involving pesticide
          Processed and monitored disbursement of  ce.ation
          monies.
          Distributed and participated in presentati
          "Health  Personnel" and "Firefighter" trainograms
          Expanded public participation activities.
 EPA F*i« 2410-10 (t-78)

-------
                  ENVIRONMENTAL PROTECTION AGENCY


FORM 1:  DECISION UNIT OVERVIEW
 A) DECISION UNIT TITLE (AND CODE)

    PESTICIDE USE MANAGEMENT   (E240)
HQ

REG.X
MEDIA: PESTICIDE

APPRO: A & C
  D) FY 79 PROGRAM DESCRIPTION


         Continue applicator certification programs
         and continue  Federal certification in  Colorado  and
         Nebraska.
         Disseminate IPM materials to farm community.
         Assist States  in upgrading certification  programs.
         Participate in  IPM  and health and safety  workshops and
         training sessions.
         Maintain responsiveness to inquiries and  requests  for
         assistance from registrants.
         Investigate pesticide  accidents and establish PIMS
         agreements.
         Participate in  IRLG activities.
         Increase public participation activities.
EPA Form 2410-10 (g.78)

-------
                ENVIRONMENTAL  PROTECTION  AGENCY

FORM 2: DECISION UNIT LEVEL  ANALYSIS
A, DECISION UNIT TITLF  AND  CODE
E240 PESTICIDES USE MA
RG
                                                HfDIAj PEST
                                                APPR(.t A & C
R. RESOURCE SUMMARY      FY  78  ACT  FY  79  C.  F.
        POSITIONS  PFT        JP.O         ib.o
 LEVEL            OPFT          /4.o          5.0
0) OF »5           FTE                     54.6
   BUDGET AUTH. (000.0)    1,566,0      1,209.2
                                                    Ło INCR
                                                       26.0
                                                        1.0
                                                       27. a
                                                    1,021.9
                      FY  80  CUM
                           26.0
                             1.0
                           27.4
                        1,021.9
    C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
      OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.

     Activities

         Certification  and  Training - Provide limited oversight
     and regional  assistance  in implementation of approved State
     Plans; monitor  certification grants and  State plans  for
     compliance  and  provide assistance in amending plans  as
     requested.   Ensure conduct of  Federal certification  program
     in two States without  plans (Nebraska and Colorado),
     including upgrading  and  evaluation of examinations.
     Provide  guidance  to  Indian nations for certification plan
     development.  Ensure that all  applicators who require
     certification are  certified to use restricted use
     pesticides.
         IPM  - Initiate information gathering activities  on IPM
     in some  regions.   Develop four IPM profiles.
         PIMS  -  Provide for the establishment of 12 PIMS
     agreements.   Conduct 6 PIMS workshops and respond only
     to serious  pesticide incidents.
         Liaison/Public Participation - Provide a broad spectrum
     of response  to  public  and pesticide interest groups  ranging
     from  full outreach on  matters  of some import to reactive
     response  on  less  important issues.  Participate in some 10
     IRLG  training sessions and in  10 IRLG joint inspections.
         Other Regulatory Activities  - Provide a range of
     response  to  registrant inquiries, including referral to
     headquarters, active problem solving, and technical
     assistance.   Audit 9 State certification programs for
     compliance  to approved plan.
         Health  and  Safety  -  Five health and  5 fire safety
     programs  will be  coordinated and monitored for effect upon
     States'  response  to  future episodes and  input into PIMS and
     Agency response programs.

     Impact;   Funding  this  level would ensure that States have a
     cadre  of  competent applicators to apply  restricted use
     pesticides.   It would  also insure the availability of
     restricted  use  pesticides to applicators in States without
     plans.

         IPM  profiles  would provide an information base upon
     which  regulatory  decisions can be made.
     U2SO
  EPA Form 2410-11 (8-78)

-------
                   ENVIRONMENTAL PROTECTION AGENCY
FORM 2:  DECISION UNIT LEVEL ANALYSIS
  A. DECISION UNIT TITLE (AND CODE)

    PESTICIDE USE MANAGEMENT     (E240)
                 HQ

                 REGX
MEDIAPESTICIDES

APPRO: A & C
  B. RESOURCE SUMMARY
FY 78 ACTUAL  FY 79 C. EST.   FY80INCR.
     FY 80 CUM.
LEVEL
1 OF 5
continued
POSITIONS PFT
OPFT
FTE
BUDGET AUTH. (000.0)
















  C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
    OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.
       PIMS  agreements would  provide an  effective post
   registration check on  the  effect of pesticides upon
   applicators  in field use  situations.

       Not  funding this level  would result  in the cessation  of
   all certification activities.   The Administrator would  loose
   an important regulatory option (restricted use to certified
   applicators) and the Agency would be  in  a  reactive posture
   only for  pesticides incidents.   All registrant inquiries
   for registration would have to be referred to Headquarters.
                                                           U2S1
EPA Form 2410-11 (8-78)

-------
                 ENVIRONMENTAL PROTECTION AGENCY

FORM ?: DECISION UNIT  LEVEL ANALYSIS
•'•"•"•"•••••••'•••"••'"••••••••••••••••^••••••(•••••••••••••••••••••••••(••KBW
A, DECISION  UNIT TITLE AND CODF        RG      MEL>IA|  PŁST
E240 PESTICIDES  USE  MANAGEMENT                 APPRO*  A & C
*1"»*w'*""*"B"<*IB>*"i»w^<****'''**»»»<"»<»w»«»»»<»»w»w»»»»w«»»»w»»»WBi«»»»»w»«Ki»www»«p«»wap
B, RFSUURCE  SlJMMAWY       FY 7fe ACT FY 79 C. F.   FY  60  INCR   FY 80 CUM
        POSITIONS  PFT        39.0         16.0          1.0        27.0
 LEVEL             OPFT         4.0         5.0          1.0         2.0
02 OP Ob           FTE                     341.6            6        28.0
   BUDGET AUTh.  (000.0)     I,bb6.u     1,209.2         54.3     1,076.2
    C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
      OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.


      Activities

          Certification and Training  -  Upgrade 1  region's  ability
      to work with Indian nations  for program  development.
          IPM - Develop 4 additional  IPM  profiles.
          PIMS - Establish  additional 4 PIMS agreements and  hold  1
      PIMS Workshop.
          Liaison/Public Participation  -  No additional  activity.y
          Other Regulatory  Activities  -  Provide  for an additional
      10%  increase in  response  to  inquiries.
          Health and Safety -  No additional activities.

      Impact;  Funding this level would provide assistance  to
      Indian  nations in a region which  has  a significant  Indian
      population.  A slightly  broader scope of IPM information
      development would be  provided  and  the network of  PIMS
      cooperators would be  extended.

          Not funding  this  level would  limit the  Agency's  ability
      to reach Indian  nations  in a  region where they are
      significant in number;  and result  in the Agency adopting  a
      non-reponsive posture to  requests  by Indians for  assistance.
      IPM  information  gathering would be  limited  to a few
      geographical areas while  the  Agency's decisions are  national
      in scope.  Also, the  Agency's  ability to collect  pesticide
      incident information  and  respond  to significant incidents
      would be limited.
  EPA Form 2410-11 (8-78)

-------
                ENVIRONMENTAL  PROTECTION AGENCY

FORM ^•t DECISION  UNIT  LEVEL  ANALYSIS
•••••»«••••••••••*mmmmmommm»mmmmmmmmmmmmmmmmmmmi
A. DECISION UNIT  TITLE AND  CODE
E240 PESTICIDES USE
                                                    Af PEST
                                                APPRO! A & C
B, RESOURCE SUMMARY
        POSITIONS  PFT
 LEVEL            OPFT
03 OF ob           FTE
   BUDGET AUTH.  (000.0)
                          FY  78  ACT FY 79 C. f,
                               39.0        16.0
                                4.0         5.0
                                           34.6
                            J,?>66.0     1,209.2
FY so
       4,0

       3.4
     147.3
FY 80 CUM
     31.0
      2.0
     31.4
  1,223.5
    C.  DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
       OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.

    Activities

         Certification and Training - Increase  regional
    capability to provide assistance for  Indian  nations.
         IPM - Provide for the development  of  10  additional
    State IPM profiles, and the initiation  of  10  IPM training
    sessions.  Expand regional capability  to  provide IPM
    information  to farmers.
         PIMS - Develop 7 additional PIMS  agreements and 3
    additional workshops.
         Liaison/Public Participation -  No  additional regional
    public participation activities.  Expand  participation in 3
    IRLG training activities and  in 5 additional  IRLG joint
    inspections.  Expand response capability  to  inquiries by
    30%. .
        Other Regulatory Activities - Provide  an  increase  in
    response capability for registration  assistance requests.
        Health and Safety - No additional  activity.

    1mpact;  Funding this level would provide  assistance  for
    additional Indian nations, expand the  scope  of  IPM  and PIMS
    activities and ensure higher  level  of  responsiveness  to
    d nqui r ies.

         Not funding this level would negatively  impact  regional
    ability to respond to Indian  nations  for  assistance.
    Registrant requests would also be put  off  to  headquarters
    and PIMS activity would be curtailed.
   EPA Form 2410-11 (8-78)

-------

















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                      ENVIRONMENTAL PROTECTION AGENCY
 FORM 1:  DECISION UNIT OVERVIEW
  A) DECISION UNIT TITLE (AND CODE)
     PESTICIDES ENFORCEMENT (E305)
HQ OE       MEDIA: Pesticide

REG.         APPRO: Enforce.
  B)  LONG RANGE GOALS & MAJOR OBJECTIVES

  The long range goal of this decision unit is to protect public health and
  safety by assuring the safe and proper manufacture, labeling, distribution,
  and use of pesticides through the exercise of the enforcement provisions of
  the Federal Insecticide, Fungicide, and Rodenticide Act, as  amended.  Major
  objectives of this decision unit include (1) responding to emergency situa-
  tions involving substantial threats to public health and safety; (2) ensuring
  user compliance with label directions for use; (3) ensuring industry compli-
  ance with production and distribution requirements of the Act; (4) ensuring
  compliance with the terms of experimental use permits; and (5) initiating and
  executing all necessary and appropriate enforcement actions in the case of
  non-compliance with the provisions of the Act.

  C)  FY 78 ACCOMPLISHMENTS

  During FY 1978 the following were accomplished: maintained oversight and co-
  ordination of Regional enforcement programs; participated in six major data
  fraud investigations; assisted in development of Federal certification regu-
  lations; developed enforcement strategies for heptachlor-chlordane and re-
  stricted use chemicals; developed program for criminal investigation of data
  fraud; developed worker safety program for pesticide inspectors and laboratory
  personnel; assisted in development of legislative amendments; reviewed 84
  misuse cases and issued 30 advisory opinions and 15 label recommendations;
  conducted criminal investigation training for Regional personnel; monitored
  mirex and mercury production under terms of settlement agreements; provided
  enforcement support to RPAR process; oversaw testing program"for electromag-
  netic rodenticide/insecticide devices; and published Notices of Judgment,
  detailing the disposition of civil and criminal cases initiated under the
  FIFRA.

  D)  FY 79 PROGRAM DESCRIPTION

  During FY 1979 this decision unit will continue most of the activities of
  previous years in the areas of development of enforcement policies,
  strategies, and guidance, and development of regulations, as necessary, to
  implement legislative amendments.  Oversight and coordination of Regional
  programs will continue.  The Pesticides Misuse Review Committee will continue
  to review misuse cases and provide enforcement recommendations.  The criminal
  investigation of data fraud program will be expanded and training in this
  program area for Regional personnel will be continued and increased.
EPA Perm 2410-10 (8-78)

-------
                   ENVIRONMENTAL  PROTECTION  AGENCY

      2: DECISION  UNIT  LEVEL  ANALYSIS
A. DECISION UNIT  TITLE  AND CODE         HQ        HŁDIA|  PŁST
E305  PESTICIDES ENFORCEMENT                        APPRO|  ENFORCEMENT

B. RESOURCE SUMMARY       FY  76 ACT  FY 79  C. E.   FY 6Q  INCR    FY  80 CUM
         POSITIONS  PFT          56.0          37.0          28. 0          28,0
 LEVEL              OPFT           5.0           3.0           3.0           3.0
01 OF  05             FTE                        51. 8          36.8          36.8
   BUDGET  AUTH.  (000,0)     6,200.0      1,334.7      1,OM,0       1,081,0
   C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
      OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.

   At this level,  the following activities would be performed by this decision
   unit:

   *  Provide guidance and  oversight in taking enforcement  actions in emergency
      situations involving  substantial threats to public health and safety,
      including recalls and product suspensions.
   *  Provide guidance and  oversight in performing enforcement activities which
      contribute substantially to the protection of public  health, in particular
      enforcement  of  pesticide use and application.
   *. Improve enforcement methods by giving priority to cases of national or
      regional significance with visibility and educational deterrent effect;
      increasing use  of criminal actions in selected significant situations;
      improving overall litigation and investigative abilities, including
      criminal case preparation; seeking more effective methods of compliance
      monitoring,  including special intensive audits; and extending cooperative
      enforcement  efforts with other Federal agencies.
   *  Develop and  issue policies, operating procedures, guidance, and regulations
      especially those pertaining to oversight of enforcement of Federal certifi-
      cation of applicator  programs and criminal investigations of data fraud.
   *  Provide capability for criminal investigation of data fraud as a followup
      to the OPP/FDA  laboratory audit program.
   *  Develop strategies and plans and establish program priorities.
   *  Assess and review Regional programs.
   *  Provide legal support in case development, enforcement strategy, litigation
      and settlement.

   Funding this level would provide a minimal oversight, guidance, and program
   support capability at Headquarters/NEIC.

   Not  funding this level would eliminate the Headquarters  role in the pesticides
   enforcement program, leaving the program without centralized direction or co-
   ordination.
 EPA Form 2410-11 (8-73)

-------
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                     ENVIRONMENTAL PROTECTION AGENCY
FORM 1:  DECISION UNIT OVERVIEW
  A) DECISION UNIT TITLE (AND CODE)
     PESTICIDES ENFORCEMENT (E305)
HQ

REG.
X
MEDIA:pesticiae
     - Enforce.
 B)  LONG RANGE GOALS & MAJOR OBJECTIVES

 This decision unit combines the functions and responsibilities  of  the Pesti-
 cides Enforcement and Pesticides Enforcement Grants  decision units at the
 Regional level.   Goals of this decision unit are to  (1)  protect public health
 and safety in the manufacture, labeling,  distribution,  and  use  of  pesticides
 by exercising the enforcement provisions  of the  Federal Insecticide,  Fungicide,
 and Rodenticide  Act (FIFRA),  as amended,  and (2) strengthen Federal-State  co-
 operation in enforcing the FIFRA.   Major  objectives  include (1) responding to
 emergency situations involving substantial threats to public health and safety
 (2) establishing Federal-State cooperative enforcement  grants;  (3) ensuring
 user compliance  with label directions;  (4) ensuring  industry compliance with
 production and distribution requirements; (5)  ensuring  compliance  with terms
 of experimental  use permits;  and (6)  initiating  and  executing all  necessary
 and appropriate  enforcement actions in  cases of  non-compliance  with the Act.

 C)  FY 78 ACCOMPLISHMENTS

 During FY 1978 the following  were  accomplished by this  decision unit:   estab-
 lished grants-in-aid with 34  States and Territories  with total  funding of «
 $5.048 million;  maintained oversight  and  monitoring  of  grant activities  and
 provided training,  legal  and  technical support,  and  case preparation  assis-
 tance;  in those  States  participating  in the grant program,  State personnel
 conducted part or all of  the  pesticides enforcement  functions,  including use
 and re-entry,  establishment*  and marketplace inspections, and took enforcement
 actions;  in non-participating States  and  to a  degree in  States  with grants,
 EPA conducted  such  compliance monitoring  and enforcement functions; import
 surveillance activities conducted  for the most part  by EPA;  enforced  Federal
 certification  of applicators  program  in two States not having approved  certifi-
 cation programs  in  place;  participated in data fraud investigations.

 D)   FY  79  PROGRAM DESCRIPTION

 During  FY  1979 this  decision  unit will concentrate upon  the  development  of
 Federal-State  cooperation  in  the enforcement of  the  FIFRA by establishing
 additional grants-in-aid.   Grants will be established with as many  of  the 56
 States  and Territories as  possible, with  at  least 43 expected;$8.96 million
 will be available for funding grants.  Oversight and monitoring the grants will
 be performed and training,  legal and  technical assistance and case preparation
 support will be  provided.   Enforcement of Federal certification of  applicators
 will be carried  out  in  two States.   Import surveillance  will be conducted and
 criminal  investigation  of  data traud  will be carried out.  Routine  compliance
 monitoring and inspectional activities will be severly restricted  in  favor of
 State-conducted  compliance monitoring.


                                                                     J3C1
EPA Form 2410-10 (8-78)

-------
                   ENVIRONMENTAL PROTECTION AGENCY
FORM  21  DECISION UNIT  LEVEL
A,  DFCIblUN UNIT  TITLE  AND  CODE          RR       MEDIAPE $
EJ05  PESTICIDES  ENFORCEMENT                       APPROj ENFORCEMENT
         * ** " * ** ** ** *****'****** *• W •> •• W •• (• •• V **>>^WMMWIB*WWM1WW|V • M M W •• • • M ** M M  ^ M • M
B.  RESOURCE SUMMARY       FY 76 ACT FY  79 C. E.  FY  BO INCR    FY*6o"cUM
         POSITIONS  PFT         13B.O         85.0         72.0          72.0
 LEVEL              OPFT           7.0          5.0           a.O           <| . P
°i  PF  °*             FTE                       ne.fe         e«.2          e«.2
         T  AUTH.  (000,0)      a, 700.0      2,157. «      1,P75.5      1,875 5
   C.  DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
      OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.

   At this level, the following  activities will be performed by this decision
   unit:

   *  Respond to emergencies  involving  substantial threats to public health and
      safety, including recalls.
   *  Review applications for enforcement grants-in-aid under Section 23(a)(1) of
      the FIFRA and determine acceptance or denial through the Regional Pesti-
      cides Enforcement Grant Review Panels.
   *  Conduct oversight and monitoring  of grant activities and provide training,
      legal and technical assistance, and case preparation support  to States.
   *  Enforce Federal certification  of  applicators programs in two  States.
   *  Participate in criminal investigations  of data fraud by private testing
      laboratories.
   *  In States without grants and if necessary in States with grants, and  to the
      degree resource constraints allow, perform limited compliance monitoring
      and inspectional activities contributing to ensuring user compliance  with
      label directions, industry compliance with registration requirements, and
      compliance with the terms  of experimental use permits.
   *  Conduct import surveillance, establishment registration, and  monitoring of
      Section 18 exemptions.
   *  Initiate and execute all necessary and  appropriate enforcement actions in
      cases of non-compliance with the  Act, whether the result of State or  EPA
      compliance monitoring activities.
   *  Generally improve enforcement  methods by cooperating more effectively with
      States to achieve overall  more effective Federal-State enforcement; give
      priority to cases of national  or  regional significance with visibility and
      educational deterrent effect;  increase  use of criminal actions in selected
      significant situations; improve overall litigation and investigative
      abilities, including criminal  case preparation; and seek more effective
      methods of compliance monitoring, including special intensive audits.

   Funding this level would provide  an  absolutely minimal capability in each
   Regional office to manage  a pesticides enforcement program; assumes most en-
   for'cement activity will be conducted by  States under terms of grants with
   Regional staffs operating  primarily  in an  oversight and management role.

   Not  funding this level would  eliminate the Regional role in the  pesticides en-
   forcement  program and, as a  practical effect, severely limit the effectivenes
   of the cooperative grant program  for lack  of proper oversight and management.
 EPA Form 2410-11 (8-78)

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                     ENVIRONMENTAL PROTECTION AGENCY

FORM 1:  DECISION UNIT OVERVIEW
  A)  DECISION UNIT TITLE (AND CODE)                    HO. OE       MEDIA: Pesticide

     PESTICIDES ENFORCEMENT  GRANTS  (E310)            REG.         APPRO: Enforce.
  B)  LONG RANGE GOALS  &  MAJOR OBJECTIVES

  The long-range goal  of this decision unit  is  to establish, foster, and
  strengthen effective cooperation between the  Federal government and  the
  States  in  the enforcement  of the Federal Insecticide, Fungicide, and Rodenti-
  cide Act (FIFRA),  as amended.   Specific major objectives of this decision
  unit include:  (1)  establishing  Federal/State, cooperative enforcement grants-
  in-aid;  (2)  encouraging States, through the grant program, to adopt  and
  execute pesticides enforcement  policies, priorities, and activities  comparable
  to  those observed  by EPA;  (3) designing and conducting training programs for
  State pesticides enforcement personnel; and  (4) ensuring timely transfer of
  funds to grantees.

  C)  FY 78 ACCOMPLISHMENTS

  During  FY  1978 this  decision unit realized the following accomplishments:
  developed  grants-in-aid with 34 States and Territories with total funding of
  $5.048  million; under  provisions of the grants, producer establishment, use
  and re-entry,  and  marketplace inspections were performed by participating
  States.  In  addition,  guidance  to the Regions for the development of grants
  was provided,  proposed  grant regulations were published in the Federal
  Register,  and planning  was  begun for the establishment of an integrated
  laboratory facility  to  be  operated by the State of New Jersey.

  D)  FY 79 PROGRAM DESCRIPTION

  During  FY  1979 this  decision unit will further develop Federal/State coopera-
  tion in  the  enforcement of  the FIFRA by establishing additional grants-in-aid
  with States  and Territories.  At least 43 grants are envisioned although all
  56  entities  will be  approached; $8.96 million in grant funding will  be avail-
  able.   Training programs in  pesticides enforcement functions will be provided
  for State  personnel.  Final  grant regulations will be promulgated.
     J3L3
EPA Form 2410-10 (8-78)

-------
                   ENVIRONMENTAL PROTECTION AGENCY

FOPM  ?! DECISION UNIT  LEVEL  ANALYSIS

A.  DECISION UNIT TITLE  AND CODE          HO       MgDIAj PEST
E310  PESTICIDES  ENFORCEMENT  GRANTS                APPROt ENFORCEMENT

B,  RESOURCE SUMMARY       FY  78 ACT  FY  79 C. E.   FY  60 INCR   FY  80 CUM
         POSITIONS  PFT                        24.o          ie,o         is.o
 LEVEL              OPFT                         i.o           i.o          i.o
01  OF  no             FTE                        21.«          22.«         22.4
    BI.UGE.T  AUTH,  (000,0)                    9,559.2       9,200.0     9,200.0
   C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
     OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.
   At this level, the following activities would be performed by this decision
   uni t:                                ••

   * Improve enforcement methods by cooperating more effectively with States to
    achieve overall more effective Federal/State enforcement; give  priority to
    cases of national or regional significance with visibility and  educational
    deterrent effect; increase use of  criminal actions in selected  significant
    situations; improve overall litigation and investigative abilities,  including
    criminal case preparation; and seek more effective methods of compliance
    monitoring, including special intensive audits.
   *•Review applications for enforcement grants-in-aid under Section 23(a)(1) of
    the FIFRA and provide Headquarters recommendations on acceptance or  denial to
    the Regional Pesticide Enforcement Grant Review Panels.
   * Develop and issue policies, operating procedures, guidance, and regulations
    pertaining to the grant program,
   * Assure the timely transfer of funds to grantees.
   * Develop strategies and plans, establish program priorities, and provide
    assurance of consistent Regional and State enforcement actions.
   * Develop training programs  for State inspectors and supervisors, as well as
    laboratory personnel.
   * Provide legal and technical assistance regarding FIFRA and enforcement actions


   Funding this level would provide a minimal oversight, guidance, and program
   support capability in Headquarters/NEIC.  Included in this level  is a  total of
   $8.75 million for grant funding.*

   Not funding this level would eliminate the Headquarters/NEIC role in the pesti-
   cides enforcement grant program, leaving the program without centralized
   direction or coordination.   Federal/State cooperative grants-in-aid could not be
   established,  eliminating State participation in the enforcement of the FIFRA.
  * THe Agency budget request  for the consolidated grant program includes $500,000
    from the Pesticides  Enforcement Grants allocation; this total is  not included
    in the above  resource  summary.
                                                                     J3L
 EPA Form 2410-11 (8-73)

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                  ENVIRONMENTAL  PROTECTION AGENCY

FORM  2s  DECISION UNIT  LEVEL  ANALYSIS

A, DECISION  UNIT TITLE AND CODE         HO       MEPI*| PEST
E310  PESTICIDES ENFORCEMENT  GRANTS               APPRO* ENFORCEMENT

8. RESOURCE  SUMMARY       FY  76 ACT  FY 79 C.  E.  FY  80 JNCR    Fy  80 CUM
         POSITIONS  PFT                       pa.o                       16.0
 LEVEL              OPFT                        1.0                        1.0
02 OF  oa            FTE                       21,a                       22.«
   BUDGET AUTH. (000.0)                   9,5*59.2        450.0      9,650,0
   C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
     OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.


   At this level,  the following activities would be performed by this decision
   unit:

   * Grant funding would be increased by  $450,000, bring the available funds to  a
     total of $9.2 million, a total slightly greater than that available in
     FY 1979.  Additional grants and/or grants funded at higher levels would be
     possible.
   * No additional positions are included at this level; workyears and associated
     activities would remain the same as  in Level 1.
   Funding this level would increase the  available funding  to a total of $9.2
   million.  Additional  grant funds would support additional grants and/or
   higher funding levels for grants

   Not  funding this level would result in a grant program slightly reduced in
   available funding compared with FY 1979, although the same number of grants
   could be supported.
       J31B
 EPA Form 2410-11 (8-73)

-------
                  ENVIRONMENTAL  PROTECTION AGENCY

FORM  2: DECISION  UNIT LEVEL ANALYSIS
A,  DECISION  UNIT  TITLE  AND CODE          HQ       MEUJAj PEST
EMO  PESTICIDES ENFORCEMENT GRANTS               APPROj ENFORCEMENT
 * "     ^^•'W^^wW " V W • W W W V • • W flt • V OT • W ^ • M • •IQVIP^MMWW VP W • W • • W ^ M 01 fp 01 •• • •> ^ • • 4V W • 9 •*•••>
B.  RESOURCE  SUMMARY      FY 78 ACT FY  79 C. E.  FY 80 INCR    FY 80 CUM
         POSITIONS   PFT                       2^.0                       18.0
 LEVEL             OPFT                         1.0                        1.0
03  OF  oa             FTE                       21.4                       22,4
           AUTH. (000.0)                   9,559.2        452. 2     10,102.2
   C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCRIBE THE BENEFITS
     OF FUNDING AND THE CONSEQUENCES OF NOT FUNDING.

   At this level, the following activities would  be  performed by this decision
   unit :

   * Grant funding would  be  increased by $452,200, to a total of $9.65 million.
    Additional -.funding would  be used to support  additional grants,  grants funded
    at higher levels,  one additional integrated  laboratory facility, and/or
    enforcement grants with one or more Indian nations.
   * No additional positions are included in this level; workyears and associated
    activities would remain the same as at Level 1.
   Funding this level would make available additional funding, significantly above
   that of the FY 1979 level.  Additional grant  funds would support additional
   grants, higher funding  levels for grants,  one additional integrated  laboratory
   facility, and/or grants with Indian nations.

   Not funding this level would leave the funding level slightly greater  than that
   of FY 1979.  No additional funding would be available for more grants, higher-
   funded grants, an additional integrated laboratory facility, or grants with
   Indian nations.
                                                                     J3U
 EPA Form 2410-11 (8-7S)

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