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These standards vill be as consistent as
possible with those already developed by EPA
under the Federal Insecticide, Fungicide, and
Rodenticide Act
To assure quality test data, the standards
will include rules for Good Laboratory Prac-
tices that will be modeled after those used
by FDA
The first standards — oncogenicity and other
chronic effects — will be proposed this fall;
others will follow throughout 1979
Through separate rules, the section 4 testing
standards will be applied to specific chemicals
and groups of chemicals
These rules will be issued periodically once
the testing standards are in place; the first
such rule will be proposed late this year or
early next year
Chemicals and groups of chemicals subject to
testing rules will be based on recommendations
from the section 4(e) Interagency Testing
Committee, EPA's own chemical selection pro-
cess, and other sources
Interagency Testing Committee's (ITC) initial
report to EPA (October 1977) recommended that
priority consideration be given to requiring
testing of four individual chemicals (chloro-
methane, hexachloro-1,3-butadiene, nitrobenzene,
and toluene) and six groups (alkyl epoxides,
alkyl phthalates, chlorinated benzenes, mono-
and di-, chlorinated paraffins, cresols, and
xylenes); by October 1978, EPA raust initiate
action to require the recommended testing or
explain why it is not acting
— EPA will propose testing rules directed toward
the effects to be evaluated; the rules will
apply to various substances, as appropriate
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Second Interagency Testing Committee's report
issued April 10 -- recommends priority testing
consideration for another four individual chemicals
and four groups of chemicals: acrylamide, aryl
phosphates, chlorinated naphthalenes, dichloro-
methane, halogenated alkyl epoxiden, polychlori-
nated terphenyls, pyridine, and 1,1,1-trichloro-
ethane; by April 1979, EPA must initiate action or
explain its reasons for not doing so
Establishment of Premanufacture Notification
• EPA will publish testing guidelines under section
5 identifying the information it considers neces-
sary to evaluate the risks associated with various
classes of chemical substances
9 Development 'of a system for reviewing premanu-
facture notification is under way in anticipation
of the beginning of notification early in 1979 (30
days after publication of inventory)
a Rules for "significant new uses" will follow
development of premanufacture notification require-
ments
Regulation of Chemical Substances
a PCB marking :md riisp-'Sai rule a were :.Tomulgated
February 17, 1973
• PCB regulations implementing the statutory ban on
manufacture -\m: use in any way other than totally
enclosed.marnar were proposed June 7, 1978
• Regulations on aerosol .uses of chlorofluorocarbons
were promulgated Marcn 17, 1978, in a joint action
with the Food and Drug Administration and the
Consumer Product Safety Commission
« EPA is investigating ways to further reduce
chlorofluorocarbon emissions by controlling non-
aerosol uses (e.g., air conditioners, refrigerators,
solvents), although eventual regulation will be
under the Clean Air Act not TSCA
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Ongoing reviews of high-volume, high-toxicity
chemicals will produce other candidates for
regulation over the next several months
EPA will run pilot program to provide funds for
public participation in rulemaking in connection
with PCS ban regulations
State Cooperative Agreements
$1.5 million is available in FY 78 and FY 79; it
will be provided to States under cooperative
agreements with EPA
Funds will be used in a few States for priority
programs for chemical risks for which EPA is
unable or not likely to take action
Criteria for these funds are being developed and
will be proposed shortly; award of funds is
expected in the first half of FY 79
Industry Assistance Office
Established in January 1977, as required by
section 26, to provide technical and other non-
financial assistance to industry on TSCA require-
ments, compliance measures, and Agency policy
Actions to date:
Letters
+ Over 500 Congressional inquiries answered,
plus approximately 500 routine letters
(majority from industry) received monthly
+ During the 4-month inventory reporting
period, the letter average increased to
3,000 per month with requests for
reporting forms and instructions
+ Grand total: 19,500 letters over a
19-month period
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Telephone calls
+ A toll-free number installed in January
1978 has been used to handle 6,050 calls'-
+ Approximately 3,750 other telephone
requests for assistance have been received
+ Grand total: 9,800 phone calls over a
19-month period
Seminars/meetings
+ Planned and helped conduct 32 TSCA
inventory training seminars in 28 cities
between February 27 and March 17, 1978;
more than 3,000 industry representatives
reached
+ More than 775 meetings with trade asso-
ciations and industry representatives
held (about 10 per week over a 19-month
period)
Relations With Other Agencies
• Interagency Regulatory Liaison Group (IRLG)
Was formed by EPA, FDA, OSHA, and CPSC in
August 1977 to facilitate their combined
effectiveness in conducting chemical control
activities
Eight working groups have been formed on (1)
regulatory development, (2) testing standards
and guidelines, (3) information exchange, (4)
risk assessment, (5) methodologies for
epidemiological studies, (6) coordination of
enforcement and compliance strategies, (7)
research needs, and (8) interagency communi-
cation and public education
The results of these specific initiatives,
which are currently ongoing, will be used to
develop coordinated and integrated approaches
in these areas
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In addition, the tour agencies have begun to
coordinate their activities in the 10 Federal
Reg'ions
Sections 10(b)(l) and 25(b) Interagency Toxic
Substances Data Committee (ITSDC)
— Charge is to establish an EPA system fur
collection, dissemination to other Federal
agencies, and use of data under TSCA
Basis will be EPA/CEQ survey of Federal
agencies' toxic substances data needs
and systems last year
— About 18 Federal agencies invited to
participate
— Serves as mechanism for coordinating Federal
toxic substances regulatory reporting and
recordkeeping requirements
TSCA Interagency Testing Committee
— EPA is a member and provides support as.
required under section 4(e)
— Purpose is to recommend chemical substances
for priority consideration for testing under
TSCA
Initial recommendations made in October 1977
and April 1978
— Recommendations will be revised at least
every 6 months; list not to exceed 50 entries
at any given time
Conclusions
By end of FY 1979, all aspects of TSCA program
will be in operation — although not each at full
capacity
Priorities are being set to direct implementation
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Initially more emphasis will be placed on obtaining
and analyzing information than on writing
specific control regulations
-- Information is needed for nonregulatory
control and for regulation under other
authorities as well as under TSCA
FY 1979 will concentrate on
Premanufacture notification system
Making priority-setting and information
systems operational
Developing testing standards and regulations
Conducting hazard assessments
Promulgating reporting and recordkeeping
requirements
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