STATES•
ONMENTAL PROTECTION AGENCY
WASHINGTON. D.C. 20460
OFFICIAL BUSINESS
PENALTY FOR PRIVATE USE S300
AN EQUAL OPPORTUNITY EMPLOYER
POSTAGt AND FEES.PAID
U.S. ENVIRONMENTAL PROTECTION AGF.NC
E PA. 3.1?
U.S. EPA Headquarters Ubrsfy
Mailcodef320i;.
1200 Pennsylvania A vg oy£ f$W
^^Environmental Newsr
Fitzwater (202) 755-0344
O'Neill (202) 755-0344
FOR IMMEDIATE RELEASE WEDNESDAY, MAY 19, 1976
EPA ADOPTS INTERIM CANCER ASSESSMENT PROCEDURES
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)
# # #
R-109
-------
-------
INTERIM PROCEDURES & GUIDELINES FOR-HEALTH RISK AND
ECONOMIC IMPACT'ASSESSMENTS-OF SUSPECTED-CARCINOGENS
-------
-------
PREAMBLE
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
carcinogens.
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'.
-------
-2-
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.
-------
-3-
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
-------
-4-
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-
sideration.
-------
-5-
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.
-------
-6-
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
i
personally with leading authorities in this area as part of a continuing
process to discuss these cancer policies and exchange information
and views. , --- ' •
o
Administrator
-------
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
problems.
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.
Applicability
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
i
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.
-------
•A-
4. Proposed technology-xba-§e(d regulations 'or revisions
pursuah'tHo Sections 301, 30,4, 306, ^07
-------
-4-
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
package.
-------
- 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
Reregister
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
v
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
package.
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
Institutions.
-------
APPENDIX I
-------
-------
Interim Guidelines
for
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
a
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.
i
The risk assessment document will contain or identify by reference
the background material essential to substantiate the evaluations contained
therein.
-------
- 2 -
2. o General Principles Concerning the Assessment of Carcinogenesis
Data
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
4
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-
ment.
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 species.as 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
exposure.
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?
-------
APPENDIX II
-------
-------
INTERIM GUIDELINE FOR ECONOMIC IMPACT ANALYSIS OF
PROPOSED REGULATORY ACTIONS TO CONTROL
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
-------
-2-
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
-------
-3-
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
action.
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
commodities.
-------
------- |