CMA Q&A : THE HPV CHEMICAL TESTING CHALLENGE PROGRAM: FREQUENTLY ASKED QUESTIONS -- AND
ANSWERS!
Q 1. I received a letter from
Fred Krupp at EDF asking for my plans regarding HPV testing under the Challenge Program.
Why does EDF care, and how should I respond?
A 1. EDF recently wrote to CEOs for each of the 100 companies
that they initially challenged to test "3000 by 2000." That letter implicitly
acknowledges that commitments to test under the recent HPV Chemical Challenge Program
Framework will supercede any commitment to EDF's original "3000 by 2000" challenge. However, EDF's request to be kept specially informed of a company's
commitment(s) is not entirely consistent with the Framework (which they participated in
drafting). Therefore, any (or all) of the following responses would be appropriate in
responding to EDF:
(1) Consistent with Responsible Care?, we are committed to
evaluating hazards from our products and making that information publicly available.
(2) We are currently evaluating existing data, and reviewing
our options for testing, including forming consortia and testing by categories.
(3) In order to create a single, accurate and publicly
accessible source for tracking information, the Framework states that a wide range of
chemical-specific commitments will be made to the Commitment Tracking System. Therefore,
we prefer not to make any special or separate response.
(4) However, once our internal review is complete and our
decisions are made, EDF and any other interested member of the public can track our
commitments and progress toward meeting those commitments via the Commitment Tracking
System.
For more information on responding to
EDF, contact Steve
Russell (CMA) at (703) 741-5178.
Q 2. Where can I find more
information on EPA's view of appropriate "chemical categories" and "data
adequacy"?
A 2. EPA will hold a Workshop in Washington, D.C., December
16 and 17. The Workshop will primarily address two topics: chemical categories and data
adequacy (e.g., whether or not a particular study will satisfy a SIDS endpoint). To a
lesser degree, the Workshop also will address issues related to using structure activity
relationship analysis, testing intermediates and Class 2 (mixtures and less defined)
substances, and a limited number of right-to-know and information management issues. EPA
already has placed preliminary, draft documents on many of these topics on its web site.
With prior arrangement, Workshop participants will have an opportunity to publicly comment
on those documents and make suggestions for revisions. CMA is coordinating presentations
within CMA/CHEMSTAR, and among allied industry associations. For more information on
presenters contact Sarah Doelp at (703) 741-5222. After the workshop EPA will use the
information presented to amend and publish the guidance documents. EPA estimates that the
guidance will be available in mid-to-late January. You may register for the Workshop by
email at: chem.rtk@epa.gov, or by calling (301)
738-9786.
Q 3. Where can I find out more
about the OECD/SIDS testing program, including a description of the 13 tests and
physical/chemical information the program requires?
A 3. A tremendous amount of information about the SIDS
program (including the required tests) is available from the OECD web site at
www.oecd.org/ehs/sidsman.htm. Furthermore, EPA is offering a "SIDS 101" program
on December 15, from 7:00 to 8:30pm, the night before the HPV Workshop. You may register
for that program by email at: chem.rtk@epa.gov, or
by calling (301) 738-9786.
Q 4. Since the post-Workshop
guidance will not be available until January, has EPA considered extending the February 1
deadline?
A 4. CMA has asked EPA to extend the date (February 1) by
which a company must "sign up" if it does not want a particular chemical
included in the first test rule. CMA's request, on behalf of its members and 12 other
allied industry associations, suggests a new deadline of 45 days after the Workshop
guidance is issued. While not guaranteed, it appears that an extension until at least
March 1 is possible. EPA says it will decide on the request by December 16.
Q 5. Are there any benefits to "signing up" a chemical before February 1?
A 5. Yes. The primary benefit of signing up by the February 1
(or extended) deadline is that chemicals committed by that date will not be included in
the first proposed test rule, which EPA currently is drafting. Waiting until after
February 1 means that a chemical could be on the first proposed test rule. (We say "first" proposed rule because EPA is not expected to include all 2,800 chemicals
in the February 1 proposal.) Once listed on the first proposed rule, manufacturers and/or
importers would have to file comments on the proposed testing and findings, and/or sign up
to test the chemical. If a sponsor then commits to do the testing before December 1, 1999,
EPA will not finalize that test rule for that chemical. However, EPA will not necessarily
remove the chemical from the first proposed test rule - they simply will not finalize the
rule as to that chemical. Since it takes more Agency resources to write a new proposed
rule than to finalize an existing proposed rule, EPA could thereafter easily finalize the
rule for that chemical if (for instance) the Agency did not approve of the test plan. If
the chemical were not already on a proposed rule, EPA would have to initiate a rulemaking,
starting with a new proposed rule.
Other benefits include creating early positive momentum,
being identified as an early "leader" by EPA, greater likelihood of lab testing
space being available in the "Start Year" selected, and avoiding unnecessary
customer concern. For more information on this issue call Steve Russell at (703) 741-5178.
Q 6. Is EPA planning additional
revisions to the official HPV Challenge Program chemical list?
A 6. Yes. On December 9, 1998, EPA "removed"
approximately 40 substances (primarily polymers, inorganics, and a mix of other
substances) from the list of chemicals subject to testing in the HPV Challenge Program.
The revised list, and an explanation of the changes, are available on EPA's Chemical Right
to Know web site (www.epa.gov/opptintr/chemrtk/volchall.htm). Although the substances
"removed" actually remain on the list, they now have received a designation of
"3" in the notation column. That designation means that the chemical will not be
included in a test rule because it is a polymer or inorganic. CMA members are urged to
review the revised list to determine whether any chemical(s) of interest may have received
such a notation. Additional questions regarding the listing or designation of a specific
chemical can be submitted to EPA in writing to Charlie Auer or Barbara Leczynski (U.S.
EPA, OPPT/Chemical Control Division, 401 M Street, SW, Washington, DC 20460), or by
calling Barbara Leczynski at (202) 260-3945. Please provide CMA (attn: Jim Keith) with a
copy of any question. For more information on this issue from CMA, call Jim Keith at (703)
741-5239.
Q 7. I make only a very small
amount of a chemical (well below a million pounds), and I am certain that total US
production and import is well below a million pounds. Will EPA take that chemical off the
list?
A 7. According to the Framework, if the aggregate production
and import volume is below a million pounds, and is not expected to later go above a
million pounds, then EPA will remove the chemical from the list. (Chemicals only slightly
or temporarily below that threshold will not be removed.) EPA currently is drafting
guidance on how a manufacturer can/should raise the issue with the Agency. That guidance
will be placed on EPA's Chemical Right to Know web site sometime after the Workshop.
Questions/comments on that guidance should be directed to EPA's Barbara Leczynski at (202)
260-3945, or Charlie Auer at (202) 260-3749.
Q 8. I need help bringing
together the other producers/importers of a chemical I make. Can CMA help?
A 8. Yes. Through the Chemical Test Center
(CTC) at CMA,
association members and non members can both come together to review existing data, form
consortia, review options for forming chemical categories, and conduct any needed testing.
The CTC at CMA provides streamlined processes and brings together industry expertise and
experience so that responding to the HPV Challenge Program is as easy and efficient as
possible. Companies can contact the CTC to ask for help in setting up a panel. Questions
regarding CTC should be directed to Courtney Price, Vice President,
CHEMSTAR, at (703)
741-5600.
Q 9. When will the "Tracking
System" be available to record testing commitments?
A 9. Plans call for the initial phase of the Commitment
Tracking System web site to be available for industry-wide use by early January, 1999. At
that time, companies and consortia will be able to record all information about their
commitment necessary to avoid being listed on the first proposed test rule (i.e., chemical
name, CAS number, sponsor contact information, and designated start year.) The remainder
of the site (i.e., where detailed information regarding test plans can be submitted)
should be available by April. For more information, contact Kerry Mularczyk at CMA at
(703) 741-5225.
Q 10. How do I go about signing
up? My company received a letter from Carol Browner asking whether we would commit to the
program. Is a response to that letter the same as "signing up"?
A 10. No. There are two "levels" of responses. The
first level (the "general" commitment) is optional, but suggested. The second
level (the "chemical specific" commitment) is required, if you want to avoid
having a chemical on a test rule. Both are described below.
The "General Commitment". This response is entirely
optional. The "General Commitment" is best thought of as a broad response to
Administrator Browner's October 9, 1998 invitation to participate. The "General
Commitment" letter would indicate a company's general intent to participate in the
Challenge Program. There is no firm "due date" (although a response by the next
month or so should be an "outside" goal), and no prescribed format. Further,
there is no regulatory significance to ignoring the letter. However, companies should be
aware that EPA intends to "post" all responses (or lack thereof) on their
Chemical Right-to-Know web site. CMA recommends responding to EPA. Although EPA has placed
language for a possible response on its web site (www.epa.gov/opptintr/chemrtk), a
"General Commitment" letter to EPA should make the following points:
1. Acknowledge receipt of Administrator Browner's letter.
2. Indicate what actions you are taking (conducting data
adequacy reviews, seeking to form consortia, etc.)
3. Note commitment to Responsible Care?/Product Stewardship.
4. Make a broad statement of intent to participate in the
program ("We agree with the spirit and goals of the program, and are carefully
evaluating our products, and attempting to coordinate our work with our global
competitors.")
5. Indicate that chemical-specific responses will be sent to
the Commitment Tracking System as soon as possible.
The "Chemical Specific Commitment". This response
is required if a company wishes to test a chemical voluntarily and avoid a test rule.
Companies may submit their responses at one time for all chemicals, or submit them as
decisions are made chemical-by-chemical (most are expected this way). Chemical specific
commitments should be made no later than December 1, 1999 (preferably much sooner), and
include: CAS number, chemical name, name and contact information for the sponsor, the year
in which the sponsor elects to initiate testing, whether or not the chemical sponsored
will be tested/evaluated as part of a chemical category, and (if a consortia) each member
company participating in the consortia. The chemical specific
commitment(s) must be
submitted electronically to the Commitment Tracking System, with a copy of the same
submission also submitted to EPA. At this writing EPA has not designated where at the
Agency this commitment should be submitted.
Q. 11 When should the "test
plans" be submitted?
A. 11 Test plans are due no later than the first of the year
in which the sponsor elects to initiate testing. Test plans are to be submitted only to
the Commitment Tracking System. (This portion of the system is still under development and
should be available by April, 1999.) More information will be provided on test plans in a
later Q&A.
Q. 12 Is CMA planning to organize
a "kick-off" for the Commitment Tracking System?
A. 12 Yes. Several options are still being discussed, but the
event is planned for early next year. The exact date will depend on availability of the
Commitment Tracking System, and the extension (if any) EPA allows to the February 1
sign-up date. Prior to the kick-off we must ensure that the system is fully operational
and has undergone stakeholder review, security checks, and quality assurance. CMA also
will provide clear, concise instructions on signing up. For more information on the
kick-off event, contact Tom Gilroy at CMA at (703) 741-5804.
Q. 13 What efforts underway to
ensure global participation in HPV testing?
A. 13 CMA is working closely with the International Council
of Chemical Associations (ICCA) to implement the ICCA's goal of completing SIDS-level
assessments of 1,000 global HPV chemicals by 2004. Details regarding how that work will be
completed, and the list of chemicals to be assessed, are still being developed by the
member associations in coordination with the OECD. However, that information should be
available within the next few days, and will be posted on the CMA extranet site on the
Product Stewardship page. For additional information, contact Fred McEldowney at (703)
741-5926, or Steve Russell at (703) 741-5178.
Q. 14 I have heard that EPA
intends to "rank" company performance. How do they know which HPV chemicals I
currently make?
A. 14 EPA has said that they intend to publicize the percent
of a company's HPV chemicals that the company "commits" to test. To establish
this figure, EPA apparently plans to use as the "denominator" the number of
chemicals the Agency thinks each company makes, based on information from the 1990 and
1994 IUR reports. Obviously, this information will not be completely accurate. Therefore,
CMA members will want to check their internal list of HPV chemicals with EPA's list to
ensure that both lists are consistent. In the past, EPA has been hesitant to release this
information generically because they are concerned about releasing CBI. However, EPA may
be willing to release this information on a company by company basis. At this writing we
are unable to determine who at EPA is the appropriate contact. When we learn the
appropriate name and number, we will update this question accordingly.
Q. 15 Who can I contact at CMA
for more information on HPV chemical testing issues, including the Challenge Program?
A. 15 The following staff members of CMA's Product
Stewardship Team are available to answer your questions:
Q. 16 I read that EPA has
extended the February 1, 1999 deadline. Is that true?
A. 16 Yes. EPA Assistant Administrator Lynn Goldman announced
during the HPV Workshop on December 16 that the deadline to sign up and avoid being listed
on the first proposed test rule is extended from February 1 to March 15. CMA asked for an
extension because guidance from the Workshop (particularly on issues involving data
adequacy and forming chemical categories) was not likely to be available until late
January, and therefore too late to be useful to companies.
Q. 17 Does EPA intend to provide
information on who makes each HPV chemical?
A. 17 A formal decision has not been announced, but it
appears likely that EPA will make "non-confidential" versions of both the 1990
and 1994 IUR reports publicly available in mid or late January, 1999. If published, the
two lists would include one column for chemical name/CAS number, and another column
listing the company (or companies) that reported production or importation of that
chemical during the reporting period. (It is not clear whether EPA would include a
chemical at all if less than all companies made a confidentiality claim.) CMA has asked
EPA to clarify for the public - if EPA does publish the lists - that neither list will
accurately reflect which companies currently make or import a particular chemical.
Q. 18 How will EPA treat
information claimed as CBI under the 1990 and 1994 IURs?
A. 18 Two different OPPT Division Directors, and OPPT
Director Bill Sanders have separately offered CMA assurances in the past week that any
such list would be carefully "scrubbed" to ensure that no information claimed as
CBI in either IUR submission would be revealed, either directly or indirectly.
Q. 19 What kind of rulemaking
will EPA undertake - an Advance Notice of Proposed Rulemaking (ANPR), or a Proposed Rule
(PR)?
A. 19 According to Charlie
Auer, Director of the Chemical
Control Division, EPA currently plans to simultaneously publish BOTH an ANPR and a PR. The
PR will contain between 600 and 800 chemicals for which EPA will make the requisite TSCA
Sec. 4 (a) or (b) findings. The ANPR will list all other chemicals from the HPV list for
which EPA intends to seek data under a subsequent test rule (i.e., the chemicals on EPA's
HPV list which do not need additional data such as SIDS chemicals, polymers, and
inorganics, designated "1", "2" and "3", respectively).
Q. 20 If I volunteer to test a
chemical after March 15 but before December 1, 1999, will EPA actually remove that
chemical from the final test rule?
A. 20 Yes. According to Charlie
Auer, for chemicals "volunteered" during that time EPA will make a finding in the final rule that
generation of data will not be required. The administrative significance of this process
is subtle but important: should EPA later determine that a test plan (which does not need
to be posted until the first of the year a sponsor select to begin testing) is not
sufficient, then EPA would need to list the chemical under a new proposed rule, and offer
an opportunity for comment.
Q. 21
As the March
15 deadline is almost here, is there a street address I can use for an over night delivery
or courier service to deliver my response letter to Carol Browner instead of the P.O. box? May I also send the response letter to EPA via fax?
A. 21 A response letter may be sent by over
night delivery or courier service to the Agency at the following address:
U.S. Environmental Protection Agency
401 M Street, S.W.
Room 403ET;
Mail Code: 7405
Washington, D.C. 20460
The contact name is Charles Auer and the
phone number is 202-260-3749.
Those who wish to fax their letter may do so by using the
following fax number: 202-260-8168. Please note that the original letter
with authorized signature must follow the fax as soon as possible and must be sent to the
post office address:
Carol Browner, Administrator
US EPA
P.O. Box 1473
Merrifield, VA 22116
Attn: Chemical Right-to-Know Program
