WASHINGTON. D.C. 20460

                                          POSTAGt AND FEES.PAID

                                     U.S. ENVIRONMENTAL PROTECTION AGF.NC

                                               E PA. 3.1?
                                     U.S. EPA Headquarters Ubrsfy
                                     1200 Pennsylvania A vg oy£ f$W
  ^^Environmental Newsr

                                    Fitzwater  (202) 755-0344
                                    O'Neill    (202) 755-0344


         Interim cancer ^assessment procedures  have been adopted by the

     U.S. Environmental Protection Agency for use in making regulatory -,-

     decisions where cancer risk  is a key factor.

         The procedures implement a decision of October 10,  1975, that
     rigorous assessments of health risk and economic impact will be
     undertaken as  part of the regulatory process.

         The preamble to the procedures,, signed by EPA Administrator
     Russell E. Train, sets forth a summary statement on EPA's approach
     to regulatory  action for suspect carcinogens.  A copy of the pro-
     cedures and preamble is attached.

         In approving these procedures and guidelines, Administrator
     Train reemphasizes the Agency's commitment to reducing the burden
     of suffering from cancer caused by .factors in the environment and
     reaffirms the  Agency's policy of weighing  risks and benefits in its
     regulatory approach to carcinogens wherever possible under its en-
     abling legislation.  The procedures and guidelines will also ensure
     that the public has free access to the Agency's deliberations at
     every step.of  the process.

         The interim cancer assessment procedures are being circulated
     for comment to the other Federal agencies  and organizations with
     responsibilities in this area, including the Departments of Health,
     Education, and Welfare; Interior; Labor; Commerce; and Agriculture
     and the Council on Environmental Quality;  the National Science
     Foundation, EPA's Science Advisory Board and the EPA Pesticide
   . Adyisory Committee.
   Return thisLsheet IT you do NOT wish to receive this material Q. or if change of address is needed D (indicate change, including zip code).
  -EPA FORM I51O.1 (REV. »-72)
                               #  #  #





    In issuing the Interim Procedures and Guidelines for Health Risk and

Econonic Impact Assessments of Suspected Carcinogens, I think it appro-

priate to state once again EPA's approach to regulatory action for suspect


    Cancer is the second ranking cause of death in this country; it has

a particulary severe impact on the affected individuals and their families

in terms of physical and mental suffering and economic costs.  There is

evidence that a substantial amount of human cancer is caused by chemical

and physical agents in the environment.  Bioassay programs,, currently

testing hundreds of substances,  are beginning to show that  some impor-

tant industrial and agricultural chemicals are carcinogenic for animals

and are, therefore,  candidates for regulatory action.

    The EPA,  by law, has responsibility to regulate many agents which  may

either cause or  promote the development of cancer.  At present,  EPA is

charged with the responsibility to prohibit or restrict the use of carcino-

genic pesticides.  EPA also has authority to regulate those carcinogens

which are emitted directly to the outside air by stationary sources (such

as factories) and motor vehicles,  or discharged into  water from point

sources, or found in drinking water. Other agencies such  as the Occupa-

tional Safety and- Health Administration and the  Food  and Drug Admini-

stration also have responsibilities to regulate carcinogens.  It is important

to. emphasize that there are serious regulatory  gaps  which  permit undesirable

exposure of the  public to carcinogens.  I have strongly advocated the passage

of .a toxic substances bill to help close those gaps'.


    Regulatory action against chemical carcinogens is relatively new.

Until the late 1950's, no agents, either chemical or physical, had been

regulated in this country on the basis of their carcinogenic action with

the sole exception of ionizing radiation, which had been known to cause

cancer since the turn of the century.   Standards of permissible exposure

to ionizing radiation were set by the arbitrary use of safety factors

applied to exposure levels that we re. known to have produced damaging

health effects.  It was not assumed that these permissible exposure stan-

dards were safe but rather that they represented upper limits of exposure

with the understanding that actual exposures were to be kept as low as

possible.   In the debate over the health effects of radioactive fallout from

atomic weapons in the 1950's, the evidence for a no-threshold concept

for cancer induction emerged, which supported the idea that there is no

such thing as a completely safe dose;  in other words any exposure, how-

ever small,  will confer some risk of cancer on the exposed population.

    Evidence has accumulated that indicates  that the no-threshold concept

can also be applicable to  chemical carcinogens.  On the basis of this concept,

the first significant regulatory legislation relating to chemical carcino-

gens, the Delaney Clause of the Pure  Food and Drug Act, imposed a

complete ban on any food additive that showed evidence of tumorigenic

activity for humans or animals.  This statutory requirement represents

the approach of eliminating all risk.  However, it  has become increasingly

clear that in many areas  risks cannot be  eliminated completely without

unacceptable social and economic consequences.


    Consonant with this view,  the Federal Insecticide,  Fungicide,  Rodenti-

cide Act (FIFRA), which is the enabling legislation for the control of health

hazards  for pesticides,  requires a balancing of risks and benefits as the basis

for final regulatory action.  We, thus, have a comparable conceptual basis

for the regulation of chemicals as for ionizing radiation where.the  philosophy

has been to eliminate or reduce exposure  to the greatest extent possible .

consistent with the acceptability of the costs  involved.

    I believe that it is important to emphasize the two-step nature of

the decision-making process with regard to the regulation of.a potential

carcinogen.  Although different EPA statutory authorities have  different

requirements,  in general two decisions must be made with regard to each

potential carcinogen.  The first decision is whether a particular substance

constitutes a cancer risk.   The second decision is what regulatory action,

if any, should be taken to  reduce that risk.

    With respect to the first decision -- whether a particular substance

constitutes a cancer risk -- in very few cases is it possible  to "prove"

that a substance  will cause cancer in man, because  in most instances the

evidence is limited to animal studies.  In this regard, a substance will

 be considered a presumptive  cancer risk when it causes a statistically

significant excess incidence of benign or malignant tumors in .humans or

animals.  However, the decision that a cancer risk  may exist  does not

mean that the PJPA will automatically take regulatory action.  In the  case

of pesticides, the* decision that a.presumptive cancer risk exists will

trigger the detailed and independent risk and economic assessments  that

form  the basis for the second decision, namely,  what,  if any,  regulatory

action to take to  eliminate or restrict the use of the pesticide.  In other


reguiatory areas, for example those under the Clean Air Act, the Federal

Water Pollution Control Act,  or the Safe Drinking Water Act where a

               '                                  t        '

large number of suspect carcinogens may exist in the atmosphere or

public water supplies, the detailed risk benefit assessment will, because

of limited Agency resources, necessarily have to be carried out on a

priority basis in terms of which agents  appear to be the most important.

    Once the detailed risk and benefit analyses are available, I must

consider the extent of the  risk,  the benefits conferred by the substance,

the availability of substitutes and the costs of control of the substance.

On the basis of careful review,  I  may determine  that the risks are so

small or the benefits so great that no action or only limited action is

warranted.   Conversely, I may decide  that the  risks of some or all

uses exceed the benefits and that  stronger action is essential.

     In considering the risks, it will be  necessary to view the evidence

for carcinogenicity in terms of a  warning signal, the strength of which

is a function of many factors including those  relating to the quality and

scope of the data, the character of the  toxicological response, and the

possible impact on public  health.  It is  understood that qualifideations

relating to the strength of the evidence  for carcinogenicity may be

relevant to this consideration because of the uncertainties in our

knowledge of the qualitative  and quantitative  similarities of human and

animal responses.  In all  events, it is essential in making decisions about

suspect carcinogens that all relevant information be taken into con-



    In my opinion, the current guidelines represent a significant improve-

ment in the  Agency's approach to the processes of decision-making for

carcinogens by providing improved procedures, for making risk and benefit

assessments while providing the maximum opportunity for public review

of the Agency's deliberations.  However,  while these guidelines should

improve Agency procedures, 1 do not view them as representing a change

in the Agency's cancer policy.  Earlier regulatory decisions involving var-

ious pesticides were also based in each case on a comprehensive evaluation

of the scientifc evidence and a careful weighing of risks and benefits.  These

decisions in every instance resulted in selective control measures rather

than a com pie tev prohibition of use.

     I want to emphasize that I will not permit these new procedural guide-

lines to unduly delay regulatory decision-making.   1 will be closely  reviewing

them to assure that they do not do so.  If they do cause undue delay, they

will be revised.  1 would like to point out that these  guidelines provide a

means of organizing available  information rather than requirements for the

acquisition of new information.

     I believe that the approach presented here is a significant step toward

the objective of achieving real benefits in improved public health while

avoiding the burden of undesirable regulatory action.  I recognize that

the aspect of cancer research dealing specifically with the issues involved

in decision-making is  relatively undeveloped, but hopefully the commitment

. of this Agency and other Federal agencies to the development of new know-

ledge in this area  will improve the  scientific basis for regulatory decisions

and that the Interim Procedures and Guidelines  will thereby benefit from •

 periodic  revision.

    I consider it extremely important that the leading government agencies

work closely with each other and with experts outside  the government in

the field of carcinogenicity in the development of government procedures

and policies concerning cancer.  I am publishing these interim procedures

and the  guidelines in the Federal Register not only to provide public notice

of the approach which EPA will be following in our current activities but

also to stimulate commentary from all sources upon that approach,   I am

also furnishing copies of these Interim Procedures and Guidelines to and

requesting the views of the Secretaries of Health, Education, and Welfare,

Interior, Labor,  Commerce and Agriculture and also the Council on

Environmental Quality,  the  National Academy of Sciences, the National

Science Foundation, EPA's  Pesticide Policy Advisory Committee and

EPA's Science Advisory Board, among others.  I also plan to meet
personally with leading authorities in this area as part of a continuing

process to discuss these cancer policies  and exchange information

and views.               ,        --- '      •

    Interim Administrative Procedures for Regulatory Decisions
                  Involving Suspected Carcinogens
     Procedures described in this paper provide a more uniform Agency

approach to regulatory decisions involving cancer risk.  Procedure A

applies to pesticide decisions involving the cancellation,  suspension and

registration of potentially carcinogenic pesticides.  Procedure B applies

to other selected Agency decisions where the pivotal factor in the-decision

is cancpr risk.

     The purpose of these procedures is to assure that appropriate ana-

lyses of the risks and benefits of suspected carcinogenic chemicals are

performed as part of the regulatory process.  Appendices I and II establish

guidelines for risk assessment and economic impact analyses. These guide-

lines are procedural  guidelines and are not intended to affect the substantive

regulatory standards of any statute.  Therefore, the assessment of the risk

posed by potentially carcinogenic substances will be made pursuant to the

individual standards of the applicable statute and regulations.  Furthermore,

these analyses will bf carried out within the constraints of Agency resources

and will not delay actions by the Agency to address urgent environmental


     The Cancer Assessment Group (CAG) is an advisory body comprised

of senior scientists from within the Agency with a liaison member from

the Department of Health, Education and Welfare.  It  will also utilize,

as appropriate, expert consultants and advisors from various Federal

Agencies and the private sector.   The CAG will conduct analyses  of data

related to risk and make recommendations to the lead program office

and the appropriate Working Group concerning the risk associated with

                                - 2 -

each suspect carcinogen.  These analyses will be directed towards risk

assessment and will be conducted independently of economic impact

analyses.  The, CAG will also review the final risk assessment portion of

the regulatory  package.


     For all decisions involving the cancellation, suspension, rpregis-

tration and registration of potentially carcinogenic pesticides, -Procedure

A will be followed inclusive of the preparation of (I) a risk assessment

pursuant to the interim guidelines contained in Appendix I and (2) an

economic impact analysis  pursuant to the interim guideline contained in

Appendix II.

     For the following rulemaking,  where the pivotal factor in the

decision is cancer risk,  the procedures outlined in EPA Order 1000. 6

will be followed,  and in addition, a risk assessment  pursuant to

Appendix I  will be prepared and will be reviewed in accordance with

Procedure  B:

     1.   Proposed regulations to augment thp current list of  toxic

         substances published pursuant to Section 307(a) of the FWPCA

         and any  standard)  proposed under this augmented  listV

     2.   Primary drinking water regulations or revisions thereof

         under Section 14i2 of SDWA.

     3.   Additions to or  revisions of the  water quality criteria

         (pursuant to Section 304(a) of FWPCA) currently  pending

         publication,  except that detailed exposure patterns and esti-

         mates of cancer risk heed not be prepared.

     4.  Proposed technology-xba-§e(d regulations 'or revisions

        pursuah'tHo Sections 301, 30,4, 306, ^07

2.   OPP/Working Group Responsibility

        The Office of Pesticide Programs (OPP), in consultation

    with the Working Group, is responsible for developing a Data

    Summary Report, a Position Document (including health risk

    assessment and the  economic impact analysis) and a proposed

    Federal Register Notice at the appropriate points in the regula-

    tory process. Guidelines for health risk assessment and economic

    analysis are included as Appendices I and II.

3.   Review of a Suspect Chemical Prior to Re registration or the
    Issuance of a Rebuttable Presumption Against Registration (RPAR)

       a.   Data relevant to the carcinogenicity of a pesticide is sub-

       mitted to the CAG for review and comment.  Following review

       by the CAG,  a Data Summary Report is prepared by OPP and

       the Working Group.  This report includes a summary of all

       available data rplpvant to carcinogenicity.

       b.   A draft Position Document including the Data Summary

       Report, a summary of the issues surrounding potential

       regulatory actions, and a proposed Federal Register Notice

       are presented to the Pesticide Chemical Review Committee

       (PCRC) which includes a representative from the CAG.

       c.   On the basis of PCRC comments, the OPP and the

       Working Group revise the draft Position Document and the

       Federal Register Notice.  The PCRC reviews the revised


                       - 5 -                    "   •

       d.  The package recommending a reregistration or the issu-

       ance of a RPAR goes to the Deputy Assistant Administrator

       for Pesticide Programs for a final decision.

4. Post-RPAR: Issuance of a Notice of Intent to Cancel, Suspend or

       a.  After a RPAR is issued, and rebuttal information if any is

       submitted, the OPP and the Working Group develop a final

       Position Document.  This document includes a summary of all

       information available in rebuttal of the RPAR,  a recommended

       finding on whether or not the presumption against registration

       has been rebutted (including the risk assessment),  economic

       impact analysis as  necessary,  a"summaryof the-issues

       surrounding potential regulatory actions,  and a draft Federal

       Register Notice.

       b.  The final Position Document is reviewed by PCRC and

       the risk assessment is reviewed by GAG.

       c.   If the decision is to reregister the product,  a notice to

       this  effect is published in the Federal Register.

       d.   If the decision is to cancel or suspend the product, the

       proposed notice of intent to cancel or suspend is forwarded

       to  USDA and the Scientific Advisory Panel for comment,

       pursuant to the 1975 amendments to Section 6(b) of FIFRA.

       However, if it is determined that suspension of the pesticide

       is  necessary to prevent an imminent  hazard to humans, the

       1975 amendments provide for waiver of the requirement for

       consultation with USDA and the Scientific Advisory Panel.

                                - 6 -

        The notice of intent to register, cancel or suspend, including the

    risk assessment and economic impact analyses,  is circulated for

    General Counsel and Assistant Administrator concurrence and forwarded

    to the Administrator for a final decision.

B.  Other Rul^making to Regulate Carcinogens

        All  other Agency decisions involving carcinogenesis as the pivotal

    factor will follow EPA Order 1000. 6 with the following additions:

        1-.   The CAG will review the relevant data during the develop-

            ment of the  rulemaking and make recommendations to

            the lead office and the working group regarding the interpre-

            tation of the data and provide other advice, as appropriate,

            concerning the risk assessment.

        2.   The CAG will review that portion of the rulpmaking package


            containing the risk assessment.  CAG comments will be  pre-

            sented to the Steering Committee.

C.  External Scientific Review

        In addition to the external reviews required by statute and the

    1000.6  process,  other external scientific review will  be obtained in

    appropriate cases as determined by the lead program office.  This

    review  may take place at any time in the development of the regulatory


         While  risk and economic impact analyses may be reviewed exter-

    nally, regulatory recommendations will not normally be submitted for

    external review.  Reviewers  for risk analyses may be from the

    Advisory Board, National Cancer Institute,  or other appropriate




                            Interim Guidelines
                       Carcinogen Risk Assessment
 1.0  Introduction

      This preliminary guideline describes the general framework to be

 followed in developing an analysis of carcinogen risks and some salient
 principles to be. used  in evaluating the quality of data and formulating

 judgements concerning the nature and  magnitude  of the cancer hazard
 from suspect carcinogens.

      This guideline is to be used within the policy framework already

 provided by applicable statutes and does not alter such policies.  The

 guideline provides a general format for analyzing and organizing avail-

 able data.   It does not imply that one kind of data or another is prerequisite

 for regulatory action  to control,  prohibit,  or allow the use of a carcinogen.

 Also,  the guideline does not change  any statutory-prescribed standards as

 to which party has the responsibility of demonstrating the safety, or

 alternatively the risk, of an agent.

      The  analysis of health risks will be carried out independently from

 considerations of the  socio-economic  consequences of regulatory action.
      The  risk assessment document will contain or identify by reference

 the background material essential to substantiate the evaluations contained


                                - 2 -

2. o   General Principles Concerning the Assessment of Carcinogenesis


      The central purpose of the health risk assessmentj./ is to provide

a judgement concerning the weight of evidence that an agent is a potential

human carcinogen and, if so. how great an impact it is likely to have on

public health.

      Judgements about the weight of evidence involve considerations of

the quality and adequacy of the data and the kinds of responses induced

by the suspect carcinogen.   The best evidence that an agent is a human

carcinogen comes from epidemiological studies in conjunction with con-

firmatory animal tests.  Substantial evidence is provided by animal

tests that demonstrate the induction of malignant tumors in one or more

species including benign tumors that are generally recognized as  early

stages of malignancies.  Suggestive evidence includes the induction o\\

only those nonlife shortening benign tumors which are generally accepted

as not progressing to malignancy, and indirect tests of tumorigenic acti-

vity,  such as mutagenicity,. in -vitro cell transformation, and initation-

promotion skin tests in mice.  Ancillary reasons that bear  on judgements

about carcinogenic potential, e.g., evidence from systematic studies

that relate chemical structure to carcinogenicity should  be  included in

the assessment.

      When an agent is judged to be a potential human carcinogen,

estimates  should, be made of its  possible impact on public health at

current and anticipated levels of exposure.  The available techniques
_l/This health risk assessment is part of the risk-benefit analyses.
   In actions taken to regulate pesticides, this assessment is made
   after a determination that a health risk exists.

                                - 3 -

for assessing the magnitude of cancer risk to human populations on

the basis of animal data only are very crude due to uncertainties in

the extrapolation of dose-response data to very low dose levels and

also because of differences in levels of susceptibility of animals and

humans.  Hence, the risk estimates should be regarded only as
rough indications of effect.   Where appropriate, a range of estimates

should be given on the basis of several modes of extrapolation.

      Expert scientific judgements in the areas of toxicology,  .

pathology, biometry, and epidemiology are required to resolve

uncertainties about the quality,  adequacy, and interpretation of

experimental and epidemiology data to be used for the risk assess-


3. 0   Format of the Risk Analysis

3.1   gxposure Patterns
      This section should summarize the known and possible modes of

exposure attendant to the various-uses of the agent.  It should include

or identify by reference  available data on factors relevant to effective

dosage,  physical and chejnical parameters,  e.g., sojubility,  particle

size for  aerosols, skin penetration,  absorption rates, etc.  Interaction

of agents which may produce a synergistic or antagonistic effect

should also be  indicated,  if available.

3. 2   Metabolic Characteristics

      This section should summarize known metabolic characteristics

including transport, fate and excretion,  and biochemicaj^similarities

to other  known classes of carcinogens at high and low dose levels and

should provide  com pa risionsbe t we e n relevant well as varia-

tions in different strains of certain species.

3.3   Experimental Carcinogenesis Studies        ^x

      Available experimental reports should be-summarized.(  If some

experiments are  to be rejected for the  risk assessment, give reasons for

doing so.   Reprints of key papers and reports should be included as appen-

dices to the analysis.                           ,'~     .    •      '..•

      Judgements should be provided on the quality of the experimental

data and their interpretations for each study on the basis  of (a)'experi-

mental protocols, (b) survival.rates in controls particularly in'relation

to acceptance of  negative results, (c) incidence of spontaneous tumors

in the  control compared to general laboratory experience for the same

species or strain, (d) diagnostic criteria and nomenclature used for

tumor characterization (additional evaluation of histological material

should be obtained when appropriate),  and  (e) observed results of positive

controls (i. e., a test group given a standardized exposure to a known
carcinogen) in light of expected results.

3.4   Epidemiological Studies                     ',                      -

       Summarize epidemic logical studies,  together with critiques  of the

work with respect to its limitations and significance.  Summarize  other

published critiques  whether supportive or at: variance  with the judgement

made  here.

 3. 5   Cancer Risk Estimates          "           '

 3.5.1  Exposure Patterns

        Describe likely "exposure leyels with- respect to long-term tem-

 poral trends, short-term temporal patterns,  and weighted averages for

 both the total exposed populations-and for subgroups whose exposure

                                - 5 -

patterns may be distinctly different from the average.  Characterize, to

the extent possible, the size of the exposed population for each of the

above categories with an indication of whether the exposures are likely

           x •     -                 '               •
to involve children and pregnant women.  Discuss the adequacy of the

methods used to estimate exposures and indicate the range of uncertainty

in the estimates.

3. 5. 2  Dose-Response Relationships

       Both human and animal data should be used as available.  Include

available human data, even if inadequate for a characterization of the

actual magnitude of risk, where such data could be helpful in interpreting

animal responses in relation to human sensitivity.

3. 5. 3  Estimates of Cancer Risk

       The procedure will involve a variety of risk extrapolation models,

e.g., the linear non-threshold model and the log-probit model.  Analyses

will be done separately for all suitable experimental data and  human epi-

demiological data. The results should be presented in terms  of excess

lifetime incidence, or average excess cancer rates; life-shortening

estimates  should also be made when the data permit. The uncertainty

in the data and extrapolation techniques should be clearly indicated.  The

results predicted for humans should be  presented in relationship to the

current cancer experience  in the  assumed target organ(s).

       Some judgements should be included regarding the relevance of

the mode of exposure used  in animal studies to that associated with human


4.0  Summary

      The  summary section of the risk assessment should provide  a

                                - 6 -
statement which encompasses answers to the following questions: (1) How

likely is the agent to be -a human carcinogen?  (2) If the agent is a human

carcinogen, what is the estimated impact on human health?



                          CARCINOGENIC PESTICIDES
      The purpose of this guideline is to define the factors to be considered

 and the procedures to be utilized in assessing the economic impact resulting

 from future regulatory actions (as described'below) affecting carcinogenic

 pesticides.  Economic impact assessment for other regulatory actions to

 control environmental carcinogens will follow established agency procedures.

      The principal concern in the economic analysis will be the assessment of
  .;             V
 economic impacts on pesticides users  and on the 'consumers of the products of

 the users.  The impacts on pesticide manufacturers  are not germane to this

frtype of regulatory decision,  in which the risk of the use of a pesticide is compared

 to the benefit of those us^s.

      As us**d in this guideline the economic impact of the regulation is equated

 to the anticipated loss in benefit from use of the pesticide.  For agricultural

 pesticides the analysis will focus on the impacts oh" farniers,  farm productivity,
                   '\ '"
 and consumer costs associated with farm productivity.  Similarly, analyses

 of other pesticides will focus on the impacts on other user groups and related

 effects  on the economy.

 Regulatory Procedures                                        .

      The purpose of this section of the guidelines is to define how the  economic

 impact analysis fits into the regulatory framework for pesticide-relatpd actions.

      -If~a pesticide" meets or exceeds  criteria defined in 40 CFR §162.11,  a

 Rebuttable Presumption Against Registration (RPAR) will be issued.  The Agency

 will analyze any rebuttal information that is submitted; it may also take into

 account other available information to  determine whether the RPAR has been

 rebutted.  At the  conclusion of this risk assessment, the Administrator


will be presented with sufficient evidence to determine if the use of a

pesticide poses the risk of a significant adverse effect.  If such is the

case, then the Administrator must determine what type of regulatory

response is warranted.

      In making that decision, 40 CFR §162.11 provides that the Administrator

will be  provided with a preliminary assessment of the benefits of the use of

the pesticide.  Furthermore, §162.11 essentially provides: (1) that if the risks

appear  to outweigh the benefits, the Administrator will issue a notice of intent

to cancel,  which may  lead to a  full adjudicatory hearing on the question of whether

the pesticide  causes or will cause unreasonable adverse effects on the environ-

ment, or (2) if the benefits appear to outweigh  the risks, the Administrator will

either issue a notice of int*»nt_to hold a hearing (adjudicatory or non-adjudicatory)

or a notice of intent to register.  Such a notice of intent to register provides

an opportunity for a hearing upon reque'st (accompanied by submission of a state-

ment of factual reasons) of an interested party that a hearing is warranted.

The  decision  to  cancel reached at this time will not result in the removal

of a product from the market if the decision is contested.  Instead,  any

such regulatory action will be preceded by a hearing to  weigh fully the

risks and benefits of the uses of a product.

      The benefit evidence provided to the Administrator at this stage is

by definition  a preliminary staff analysis.   A  specific effort jyill be made

by the Agency to contact parties that have an interest in the use of the

pesticide and, to attempt to solicit their comments on the benefits of the

pesticide under review.  In particular,  EPA intends that the U.S." Depart-

ment of Agriculture will be heavily relied upon from the earliest stages

of review to provide its special expertise and data resources on uses.

      Because of the many variables surrounding the multiple uses of different

pesticides, the benefit or economic impact analysis must of necessity be done

on a case-by-case basis.  All relevant economic considerations raised in

criticisms of the preliminary benefit analysis will be addressed prior to final


Content of the Economic Impact Analyses

      Based upon all the available information, a preliminary analysis will

be developed.  Such analysis will be organized in the following manner:

      ?) Identification of the major  uses of the pesticide, including estimated

         quantities used by crop or  other application.

         Preliminary identification  of the minor uses of the pesticide,  including

         estimated quantities used by category such as lawn and garden uses

         and household uses.

        ) Identification of registered alternative products for the uses set

         forth in (1) and (2) above, including an estimate of their availability.

      (^Determination of thp change in costs to the user of providing equivalent

         pesticide treatment with any available substitute products.

         Assessment of regulation impact upon user productivity (e.g., yield

         per acre and/or total output) from  using available substitute

         pesticides or from using no other pesticide.

           the impacts upon either user costs or productivity are significant, a

         qualitative assessment of the regulation's impact on production

         of major agricultural commodities and retail food prices of such