HPV Challenge Program Multi-Stakeholder Meeting
Note: EPA no longer updates this information, but it may be useful as a reference or resource
American Petroleum Institute
1220 L Street
May 29, 1999
1. The meeting was opened with a welcome by David Mongillo on behalf
Mr. Mongillo gave a brief update on API's efforts to sponsor chemicals, where API is working in consort with the National Petrochemical & Refiners Association (NPRA), the Asphalt Institute, and others. To date, 47 companies have signed up for 300+ petroleum stream chemicals. These companies reflect 85 percent of the U.S. refinery capacity.
2. Allan Abramson, Director of the Information Management Division of the Office of Pollution Prevention and Toxics (OPPT) of EPA, provided the opening remarks for EPA.
Mr. Abramson commended the industry for their participation to date. So far, 200+ companies and around 60 consortia have signed up to test over 1100 chemicals. The door for sponsoring chemicals under the HPV Challenge Program closes on December 1, 1999.
EPA is beginning a series of Regional meetings to outreach to the individuals and companies that cannot travel to the DC area.
The next Multi-Stakeholder meeting is tentatively set for July. There WILL, however, be meetings in September and November. A Federal Register notice on the meeting series was published on May 5, 1999.
[At this point the formal agenda portion of the meeting commenced.]
3. API progress report from Lorraine Twerdok:
API envisions 13 test plans for all their chemicals. (They are sponsoring 362 chemicals and are reviewing an additional 45.) Two test plans are being worked on now by toxicologists, eco-toxicologists and others. One category is liquid petroleum, which will involve about 160 chemicals. The literature search (for the two) has been done and the existing studies have been entered into the database.
4. EPA progress report by Barbara Leczynski, Chief of the Existing Chemicals Branch, Chemical Control Division of OPPT:
A detailed participation summary was given. To date, 1154 chemicals (1028 full commitments and 126 provisional) have been sponsored by 232 companies (198 full and provisional and 34 interim). There are also 55 consortia with full and provisional commitments.
Two Regional meetings are currently in the works. The first will be held in Region II, New York City on June 17, 1999, with a Region VI meeting to follow either in Dallas or Houston.
The status of the proposed HPV test rule was given. The rule will include chemicals not yet sponsored. It was originally thought that about 800 chemicals would appear in the proposed rule, but that number has been reduced, as some of the chemicals have been sponsored. The proposed rule is "on the verge" of going to the Office of Management and Budget (OMB) and EPA is considering asking for an expedited review.
It is anticipated that the Final Rule in December will be the first of two or three that will eventually be needed. As chemicals are sponsored, the rule's chemical list will change.
An Advanced Notice of Proposed Rulemaking (ANPRM) is also currently in the works. This document will lay out the general strategy for the rulemaking. It will also list the chemicals on the HPV Challenge Chemical List, minus those on the first Proposed Rule and those already sponsored.
Ms. Leczynski suggested that questions follow each individual section on the agenda, rather than waiting until the end of the meeting. [Note: The questions came from both in-audience or conference call and are not attributed. The answers were generally from Mr. Abramson or Ms. Leczynski.]
Q: Is there any indication that there is "overloading" in any years for the proposed tests?
A: No. So far this is not happening.
Q: Will the newly sponsored Organization of Economic Cooperation and Development (OECD) Screening Information Dataset (SIDS) chemicals be identified on the HPV Challenge list?
A: Yes. The next update of the HPV Challenge Chemical List, which will identify those chemicals nominated in February at the OECD SIDS meeting, plus one chemical that was inadvertently left off the current list, is imminent.
Ms. Leczynski provided an update of the ChemRTK/HPV web pages:
New in the pages are a site directory, a Children's Health Testing Program section and a link to the OECD program. There is also a link to the ACC Commitment Tracking System.
Ms. Leczynski noted that the Guidance Documents on the website should be considered as "draft." It was requested that the audience review them and to please provide comments to EPA.
Q: What about companies that no longer produce the HPV chemicals that they are listed with according to the 1990 and 1994 Inventory Update Rules (IUR)?
A: We are in the process of linking the specific chemicals on the HPV Challenge list to the letters from the companies which state that they are no longer producing those chemicals. Establishing this link is difficult and presents a technical challenge, because the files are very large (preventing some users from accessing them).
Q: When will the 1998 IUR tabulations come out?
A: We are working on the 1998 IUR. The reporting cutoff was in January. Mr. Abramson noted that it will still be "several months" before the data are available.
Q: ETAD (Ecological and Toxicological Association of Dyes and Organic Pigment Manufacturers) needs more information about the HPV importers who are not listed on the website to get an idea of the real volumes.
A: The information linking companies and chemicals on the website is complete as far as the non-Confidential Business Information (CBI) information is concerned. Ms. Leczynski suggested that ETAD send a request by letter to the Agency to see whether something further could be worked out.
Q: Is there a preferred e-mail address for correspondence on these matters to the Agency?
A: There is an e-mail button in the ChemRTK web page section. That is the best way to get in contact with Agency staff working on the HPV Challenge Program.
Ms. Leczynski announced that the animal welfare fact sheet is currently in final review.
Q: There is soon to be a guidance document on the literature search methodology for chemical data. Can comments be made on that document?
A: The guidance document is considered a "draft." Yes, by all means, provide comments.
5. Mr. Abramson gave a debrief on the May OECD workshop meeting on information management.
There are two goals for the joint process -- common responsibility for testing and common ownership of the resulting data.
We are trying to reach agreement on the core content of the "robust summaries" of test data for worldwide use. We have also prepared a guidance document on assessing data adequacy for hazard assessment.
At the present time, EPA is moving along faster than the international community on finalizing the definition of a robust summary, but our version of what the robust summary will contain will be close to the description that is finally accepted. It is important to agree on the data standards so that everyone will use them.
Q: Will it be possible to tell from the robust summaries where the data came from?
A: Yes. Full citations will be provided so that the source can be tracked.
Q: Where are the formal, written responses to the questions that the People for the Ethical Treatment of Animals (PETA) submitted 2 ½ months ago?
A: EPA is still working on the responses. (Can talk offline about this later, if desired.) Information on the testing will be out with the ANPRM.
Q: What about the contracted obligations to perform testing? There needs to be some formal policy issued on animal testing required prior to the ANPRM so that contractors can schedule their work in a timely manner. In particular, when will EPA publicize its revised position policy on terrestrial toxicity testing?
A: We'll take that under advisement. Mr. Abramson agreed that the word should go out as soon as possible. [Subsequent to the meeting, EPA decided to publish this information in a Federal Register Notice, rather than an ANPRM.]
Q: Was there any talk about animal testing at the OECD meeting?
A: The agenda of the meeting was information management, so there were no formal discussions held. However, there were informal discussions.
6. Steve Russell from the American Chemistry Council (ACC) reported on the International Council of Chemical Associations (ICCA) HPV initiative.
Mr. Russell noted that information could be found at www.icca.org/hpv.
[Correct site is www.icca-chem.org. Hit "issues" button for access.]
Mr. Russell noted that the recently released list (late April) was a working list and was subject to change. Currently there are 1184 chemicals on the ICCA list, including SIDS chemicals that will be excluded from the program. 1031 chemicals appear on both the ICCA and HPV Challenge lists.
Q: How might duplication be avoided between the ICCA and HPV testing?
A: It is the responsibility of the individual companies to check with their co-producers. It would help to go through the ACC ChemStar program. These companies would need to inform the Agency of this sponsorship.
At this point Larry Rampy (CMA) clarified a point regarding chemical sponsorship notification to EPA. Notification will not come from the ICCA to EPA regarding chemicals that are being sponsored. It will be the responsibility of the consortia to notify the EPA.
7. Frank Kover, Chief of the Chemical Information and Testing Branch, Chemical Control Division of OPPT reported on the Children's Health Testing Program for EPA.
The Agency has decided to slow down work on the rule and to open a dialogue with stakeholders to determine an overall approach to the voluntary component of the program which will be announced in the Federal Register. The following groups will be invited to participate in this dialogue: children's advocacy, animal rights, industry and small business, academia, etc.
It is desired that this process provide input to the identification of and criteria for the selection of the actual chemicals that will need to be tested. The information that is needed to identify chemicals is related to toxicity and exposure (volume of release into the environment and mechanisms of exposure).
The test battery will be discussed after the Science Advisory Panel (SAP) has reviewed and completed their report. Subsequent to the dialogue process, EPA expects to offer (via a Federal Register notice) an opportunity for submission of voluntary testing proposals.
Q: When will the children's program chemicals come out?
A: The dialogue with the stakeholders must be the starting point. EPA does have a preliminary list, but will hold off on making it public until the dialogue is under way.
Q: How would a company know whether or not it's a stakeholder unless there is a list?
A: Good point. There may have to be an early release of the list to the community for comment. We will have to work as quickly as possible on this, so that the proper stakeholders can become involved at the beginning. (There was some general response, however, of the dangers of lists being developed earlier than necessary and then becoming set in concrete.)
8. Alan Goldberg from Johns Hopkins reported on the Center for Alternatives to Animal Testing (CAAT) workshop, held on April 26-27, 1999.
TestSmart was developed as the CAAT approach to SIDS testing by a consortium comprised of Johns Hopkins, the Environmental Defense Fund (EDF), the University of Pittsburgh, and Carnegie Mellon University.
The following recommendations were made at the workshop: (1) that the conventional, acute LD50 test be replaced by the more humane "up and down" lethality test; (2) that certain mammalian SIDS endpoints (repeat dose, reproductive toxicity, and developmental toxicity) be evaluated using a single, combined protocol as opposed to using three separate tests; and (3) that two in vitro genetic toxicity tests would satisfy the genetic toxicity SIDS requirements (not one in vivo and one in vitro). Following these recommendations could result in as much as an 80% reduction in the number of animals used to assess these endpoints.
Other issues discussed were the possible use of in vitro studies both to define categories and to serve as dose range-finding vehicles to identify proper doses for eventual use in in vivo tests.
They have not yet considered the problem of animal pain, suffering and distress. A possible answer in this area is to humanely kill the animal prior to its suffering pain and distress. It may be possible to move the end point forward in time, or to do more telemetry testing or to monitor urine to produce the desired testing information.
The results of the CAAT workshop will appear "imminently" on the web page at: altweb.jhsph.edu.
Q: Is there any effort to find and bring forward existing data, rather doing new testing? What is industry's motivation when a law journal suggests that industry may be exposing themselves to liability under the Toxic Substances Control Act (TSCA), if they haven't already submitted the data?
A: Larry Rampy (ACC) responded that it is in industry's own best interests to do this to the maximum extent possible. It is much less expensive, and therefore it makes good business sense, to bring forward existing data rather than to pay for testing that has already been accomplished.
Q: Will the acceptance of in vitro genetic toxicity testing apply equally in the eventual test rule as it does now in the volunteer Challenge Program?
A: Yes. There will be a consistent policy.
9. API (Lorraine Twerdok) reported on the additional chemicals that will be sponsored.
Companies are now petitioning their consortia to sign up for additional chemicals.
Q: Should they wait and send newly sponsored chemicals into the Agency when all the new chemicals have been determined?
A: No. Send chemicals in to the Agency as they are sponsored.
Prior to adjourning, the attendees were asked to vote by a show of hands as to whether they would want an interim July meeting prior to September. An overwhelming majority voted to support a July meeting.
ACC announced that they had volunteered to host the September meeting. It would take place on Tuesday, September 21, 1999 from 1:00 to 3:30 PM .
(Meeting adjourned at roughly 3:20 P.M.)
Action Items:EPA agreed to post the following information on EPA's ChemRTK Website:
The schedule for completing the 1998 IUR processing and making the data available on the web.
The schedule for putting the QSAR (Quantitative Structure Activity Relationships) document on the web. (Presently scheduled for mid-July.)
Details on July stakeholder meeting including the date, location, host, and agenda.. (The meeting is scheduled for July 27 at 1:00 P.M. at the Washington offices of the EDF at 1875 Connecticut Ave., NW. The complete announcement will be placed on the ChemRTK web page and sent directly to those on the existing stakeholder list.)
The list of attendees for this workshop. (Attached to this summary.)
EPA's literature search guidance document. (On the website.)
Any changes in the SIDS Protocol testing requirements.