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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 £• 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)
-------
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)
-------
£f> TAL PROTECTION
FORK; 2: DECISION UNIT LEVEL
A, DECISION IWIT TITLE AND CODE HQ M£UIA| 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)
-------
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)
-------
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)
-------
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
-------
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
-------
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
-------
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
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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 CCC£; HC ORD V.£3!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
-------
ENVIRONMENTAL PROTECTION AGENCY
RM1: DECISION UNIT OVERVIEW ,
Ai DECISION UNIT TITLE ;AND CCCE) HQORD MEDIA: Pesticides
I
Pesticides: Health Effects (E105) R£G- 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.
-------
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.
-------
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.
-------
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
-------
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
-------
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)
-------
ENVIRONMENTAL PROTECTION AGENCY
FORK 2! DECISION UNIT LEVEL ANALYSIS
""••"""•"••"• — •••"•••"••"••••••"•"•••••••••••••••••••••••••.»«»»» — mmvmm
A, DECISION UNIT TITLE AND CODE HQ *EDJAi P£ST
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 £: DECISION UNIT LEVEL ANALYSIS
t
DECISION UNIT TITLE AND COPE HR ME^IAl P£ST
?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 £! 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
MF.DIM PEST
APPROf R 4 D
B. RESOURCE SUMMARY
POSITIONS PFT
LEVEL OPFT
04 OF 05 FTE
BUDGET AUTH. (000.0)
FY 76 ACT FY 79 C. E. FY 6Q
8.0
354,0
8.0
8.0
400.Q
1,0
1.0
ao.o
FY 80 CUM
9.0
9.0
C. DESCRIBE THE INCREMENTAL ACTIVITIES OF THIS LEVEL ONLY. DESCHISE TH
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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^,
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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. £. 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* ' *
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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)
-------
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
7P
]
ACT
FY 79
C. E.
12.0
FY
eo
INCR
5.0
FY
80 CUM
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)
-------
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)
-------
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)
-------
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)
-------
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)
-------
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)
-------
-------
-------
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
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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 M£UIM 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 7£ 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 P£ST
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 £,• 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)
-------
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)
-------
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
£o 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| P£ST
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 H£DIA| P£ST
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)
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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)
-------
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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