EPA would like to remind each of you
that December 1 is the deadline for making commitments to the
voluntary HPV Challenge Program. EPA will soon issue a proposed
multi-chemical test rule which will capture many of the chemicals not
voluntarily sponsored as part of the HPV Challenge program. EPA also
will soon issue an Advance Notice of Proposed Rulemaking which will
outline the Agency's plans for proposing additional test rules for all
other chemicals not sponsored in the voluntary program. Following are
a handful of Q's and A's on the upcoming deadline. Please contact
Barbara Leczynski at 202-260-3946 if you need additional information
or assistance.
Bill Sanders, Director
Office of Pollution Prevention
And Toxic Substances
Question 1:
Since the November 9, 1999 Stakeholder meeting, there has been some
confusion on the deadline for signing up for the voluntary phase of
the HPV Challenge Program. Is December 1, 1999 still the deadline for "signing up" for the voluntary phase?
Answer 1:
Yes.
Question 2:
In response to a question at the November 9, 1999 Stakeholder meeting,
EPA indicated that if a "viable commitment" is received
after the multi-chemical test rule is proposed but before the rule is
final, the Agency would have little reason for finalizing that
chemical in the multi-chemical test rule. If this is true, couldn't I
sign up for the voluntary program after the multi-chemical test rule
is proposed and thereby keep that chemical from being included in the
final rule?
Answer 2:
No, a commitment received after December 1 will be considered a
commitment to do the work in the regulatory phase of the program. It
will not be considered a commitment to the voluntary phase of the
program except for the two limited exceptions outlined in Questions 4
and 5 below. A "viable commitment" to do the work under the
regulatory phase would differ in many ways from a commitment to doing
the work under the voluntary phase of the program. Work under the
regulatory phase would include agreeing to meet all of the commitments
for the voluntary program; plus:
provide evidence that work is
underway and proceeding in a timely manner,
provide data required to complete
the SIDS battery, in the time frame set by EPA in the proposed
rule; and
submit to EPA full copies of all
final study reports, in addition to robust summaries, for each
endpoint for each chemical.
In the regulatory phase, EPA will defer
making a decision on including these chemicals in a final rule until
such time as summaries and reports from all new studies and existing
data are submitted and judged to be timely and adequate. If such a
commitment is made and kept, and the information deemed adequate, EPA
would not include that chemical in a final multi-chemical HPV test
rule.
EPA will also soon issue an Advanced
Notice of Proposed Rulemaking (ANPR) which will outline the Agency's
plans for proposing additional test rules to capture all HPV chemicals
not voluntarily sponsored.
Question 3:
Will a company still have an opportunity to sponsor chemicals under
the ICCA's HPV initiative or to agree to sponsor a chemical under
OECD's HPV program?
Answer 3:
Yes. Such sponsorships would need to meet the obligations under the
respective efforts including the need to specify the start year and to
commit to completing all work (including preparation of the SIDS
Initial Assessment Report (SIAR)) expeditiously but no later than the
end of 2004.
Question 4:
If EPA receives my commitment to the voluntary program shortly after
the December 1 deadline, will EPA accept my commitment to be part of
the voluntary program and remove the committed chemical(s) from the
proposed multi-chemical test rule?
Answer 4:
EPA recognizes that holiday mail and the number of commitments
expected may result in a delay in receiving and processing
commitments. For this reason, EPA will accept commitments for a short
time beyond the December 1 deadline and will make every effort to
remove that chemical from the proposed multi-chemical test rule or the
ANPR.
Question 5:
My company requested in a letter to the Agency that a chemical on the
HPV Challenge Program chemical list be delisted because it is either
no longer HPV or it is a chemical not warranting SIDS level testing
but we have not yet received a response from the Agency.
Answer 5:
Your company or consortium should soon hear from EPA on these
requests. When a specific request is denied, EPA will offer a
two-month grace period, following the date of EPA's response letter,
to allow the company or consortium making the request an opportunity
to sponsor the chemicals.
