The HPV program has
two deadlines:The first was
recently extended to March 15, 1999, from February 1,
1999. Volunteering for a chemical or a category of chemicals by this
deadline will keep that chemical/category out of any proposed TSCA test
rule.The second deadline
is December 1, 1999. This is the final deadline for
volunteering for a chemical/category. Any chemical for which there is no
volunteer by this deadline will be included in a final TSCA test rule.
Categories will only be accepted in the voluntary program, not in the
final TSCA test rule.
Voluntary
Program Commitment Letter
Every company and
consortium/trade association must submit a letter to EPA stating the
chemicals/categories for which it is volunteering. EPA has provided
suggested language for a commitment letter on its website.EPA suggests the
following elements to include in a letter:
What you are
volunteering for;
The year in which
testing (if needed) will begin;
-- For a single substance, the start year could range from 1999 to
2003;
-- For categories, the start year must be either 1999, 2000, or 2001;
A recognition
that sponsorship entails;
-- assembling and reviewing available test data;
-- developing and providing test plans for each of the sponsored
chemicals/categories; and
-- where needed, conducting additional testing in the time frame
established by the Challenge Program.
A recognition
that the information and data provided under the HPV Challenge Program
will be made publicly available.
The following is
EPA's suggested language for a consortium/trade group. Each member company
of the consortium would also have to submit an individual letter
indicating which chemicals/categories it intends to handle through the
consortium. EPA gives several possible examples on its website for company
commitment letters. The following is an example:
The XYZ Testing
Group (XYZ) will serve as an industry consortium to coordinate testing
activities for twelve chemicals under the HPV Challenge Program, as
[listed below] [included on the enclosed list], along with dates by
which any needed testing will begin. Nine companies are current members
of XYZ as listed below, and each company will provide a commitment
letter to the HPV Challenge Program. XYZ and its member companies
understand that sponsorship entails: assembling and reviewing available
test data, developing and providing test plans for each of the sponsored
chemicals, and, where needed, conducting additional testing in the time
frame established by the Challenge Program. The information and data we
provide under the HPV Challenge Program will be made publicly available.
Ms. _____________ is XYZ's technical contact; she can be reached at
[phone number and other contact information].
HPV
and the SIDS Program
SIDS (Screening
Information Data Sets) is a cooperative program begun by the Organization
for Economic Cooperation and Development (OECD) in 1990 to "share the
burden" for testing/assessing chemicals and is the basis for the HPV
Program. OECD member countries agreed to a base set of screening tests
(SIDS) for HPV chemicals. The overall international effort (of which HPV
is a part) is intended for OECD member countries and their chemical
industries to work together in gathering data, completing the SIDS battery
of tests, and assessing the chemicals. Once a chemical has completed the
SIDS process, the information gathered is made available worldwide through
the United Nations Environment Program (UNEP). An overview of the SIDS
battery of endpoints is available on the EPA website under Workshop
Presentations.
Categories
EPA has stated that
the use of categories for fulfilling HPV data requirements can only be
done through the voluntary initiative. Once a chemical is in the final
Toxic Substances Control Act (TSCA) test rule, it cannot be grouped into a
category. While most of the Workshop was devoted to the discussion of
categories, little definitive guidance was given. Generally speaking, EPA
has said that categories must be defensible in terms of similar
properties, structural relation, metabolic relation, etc. The onus is on
the volunteering organization to justify the category. Obviously, the more
data that a volunteering organization has on a category, the greater the
likelihood of its being accepted. EPA stated at the Workshop that each
category will be reviewed on a case-by-case basis and that they currently
do not have specific guidance for how a category will be evaluated.
EPA
ChemRTK and HPV Website
EPA's ChemRTK
website contains information about the ChemRTK and HPV Challenge. Included
on the website is the updated list of HPVs, presentation materials from
the HPV Workshop, sample commitment letters, etc. The website address is: http://www.epa.gov/chemrtk/index.htm
