Status and Future Directions of the - US Environmental Protection ...

93
Flowchart Graphic 11 – Propose and
finalize Third HPV Test Rule for chemicals
for which findings can be made. Consider
risk-based findings for chemicals as
needed.
If the findings can be made, the Agency would propose
a third HPV orphan chemical test rule. EPA would
consider requesting or requiring robust summaries for
studies conducted under this test rule.
Flowchart Graphic 12 – Seek other data
development mechanism for chemicals
with continuing hazard and fate data
gaps.
The Agency solicits input on other data development
mechanisms that will help fill hazard and fate data
gaps for chemicals that remain as orphan chemicals, if
It is anticipated that the proposed Second HPV EPA’s Test High Rule Production will be published Volume Challenge in October Program
2005. At the same time, EPA would review data submitted under the HaSDR and PAIR
any.
Projected Orphans Data Data Development Development Timeline* Timeline*
Estimated Timeline First HPV Test Rule Second HPV Test Rule Third HPV Test Rule
October 2004 Data Availability/Adequacy
Analysis Initiated
8(a)/8(d) Candidates Provided to
ITC
December 2004 55 th ITC Report Published
June 2005 Final Rule Published 8(a) and 8(d) Final Rules
Published
October 2005 Proposed Test Rule
Published
January 2006 Review of Public Comments
on Proposed Rule Initiated
Review of 8(a) and 8(d)
submissions initiated
September 2006 Final Test Rule Published Proposed Test Rule Published
November 2006 Review of Public Comments on
Proposed Rule Initiated
August 2007 Final Test Rule Published
*Timeline assumes that all proposed and final rules will be subject to 90-day OMB review.
*Timeline {This is a projected assumes schedule that that all the proposed Agency will and work final to meet rules in preparing will be and subject promulgating to 90-day OMB
review. test rules as needed. Unanticipated problems or issues could result in delays.}
{This is a projected schedule that the Agency will work to meet in preparing and
promulgating
test rules as needed. Unanticipated problems or issues could result in delays.}
Beginning Beginning in October in October 2004, EPA 2004, would EPA initiate would initiate efforts Subsequently, to conduct in 2005, data it is anticipated that the First
efforts availability/adequacy to conduct data availability/adequacy searches for orphan searches chemicals HPV Test identified Rule containing for inclusion fewer than in the the 37 orphan
Second HPV Test Rule. Additionally, the list of orphan chemicals designated as
for orphan chemicals identified for inclusion in the chemicals included on the proposed First HPV Test
candidates for the HaSDR rule under 8(d) and the PAIR rule under 8(a) would be
Second provided HPV Test to the Rule. ITC. Additionally, the list of Rule would be promulgated. In December 2004, it is
orphan chemicals designated as candidates for the expected that the ITC would publish its 55th report
Subsequently, in2005, it is anticipated that the First HPV Test Rule containing fewer
HaSDR
than the
rule
37
under
orphan
8(d) and
chemicals
the PAIR
included
rule under
on
8(a)
the proposed
to the EPA
First
Administrator
HPV Test
outlining
Rule would
the Committee’s
be
would promulgated. be provided to In the December ITC. 2004, it is expected intended that the priorities ITC would and actions. publish its 55th
report to the EPA Administrator outlining the Committee’s intended priorities and
actions.
It is anticipated that the proposed Second HPV Test
Rule will be published in October 2005. At the same
time, EPA would review data submitted under the
HaSDR and PAIR rules for inclusion in the HPVIS
or for making the TSCA section 4(a)(1)(B)(i) finding
for a Third HPV Test Rule. In January 2006, EPA
would begin its review of the public comments
submitted on the Second HPV Test Rule.
In September 2006, it is expected that the Second
HPV Test Rule would be promulgated and the
proposed Third HPV Test Rule would be published,
followed by the review of public comments submitted
in response to the Third HPV Test Rule in November
2006 and final promulgation in August 2007.
Status and Future Directions
94