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Letter to Neal Barnard, PCRM re: Status of High Production Volume (HPV) Challenge Program

October 30, 2001

Dr. Neal D. Barnard
Physicians' Committee for Responsible Medicine
5100 Wisconsin Ave., NW, Suite 400
Washington, D.C. 20016

Dear Dr. Barnard:

I am pleased that we had the opportunity to meet on October 17 to discuss the progress of the High Production Volume (HPV) Challenge Program and to address a number of animal welfare issues. I also appreciate the suggestions that you provided regarding the program. As I stated at the meeting, I am firmly committed to ensuring that the HPV program provides the American public with critical environmental and health information on the chemicals most commonly found in our environment. I am also committed to ensuring that we accomplish this goal in a way that minimizes the use of animals and maximizes the development and use of alternative testing methods.

On the following pages (Enclosure 1), I address each of the four suggestions you raised: (1) integrating cellular tests into the program, (2) improving adherence to principles outlined in the October 14, 1999 letter, (3) adjusting the use of the comment period, and (4) moving forward with the intended funding for alternatives. I am also providing you with a copy of the HPV Status Report (Enclosure 2) that includes the analysis that we briefly highlighted for you last week on the amount of existing data that is being utilized in the program and the amount of proposed new animal testing. This report also contains a recently completed analysis of the first 40 test plans received to see how well companies have followed the principles outlined in the October 14, 1999, letter to HPV Challenge sponsoring companies.

As I stated at the meeting, we are strongly committed to the animal welfare principles that we have incorporated into this program and we continue to work toward the development and validation of scientifically sound tests that reduce, refine, and replace existing tests. However, despite the on-going efforts of all those involved, this is not likely to be accomplished in the near future. For this reason, and because we believe that companies are committed to reducing the need for new testing whenever possible, we feel it is important to maintain the goals of the HPV Challenge program and will proceed with the original test plan schedule for individual chemicals outlined in the October 14, 1999, letter.

Again, thank you for your interest in these issues and I look forward to working productively with you in the future.



Stephen L. Johnson
Assistant Administrator
cc: S. Hazen
      B. Sanders

Enclosure 1

Integrating Cellular Methods into the HPV Program

The Agency is pleased that we now have a cellular method to use in making dosing choices. While the animal welfare community may not believe this particular method development has moved as fast and as far as you would like, we are now at a point that the work needed to validate this method can begin. EPA will encourage HPV Challenge program sponsors to utilize this test in parallel with the currently recommended acute toxicity test. As you know, because this is a voluntary program, the Agency cannot make this procedure mandatory, however, I do believe that many of the sponsors will apply this recommendation.

Adherence to the October 14 Guidance

One specific concern you raise is the issue of the review of individual chemical test plans prior to November 1, 2001. While the October 14 letter requested that new testing on individual chemicals be deferred, the Agency did not request participants to delay the development of test plans for these individual chemicals, nor did the letter indicate that the Agency would not accept or review individual chemical test plans prior to November, 2001. Thus, we do not view these submissions as "violations" or as contrary to the program guidance in any way.

As you know, we take very seriously the principles outlined in the October 14 letter and have worked to ensure that companies are abiding by the guidance. As mentioned earlier, the HPV Status Report includes an analysis of the first 40 test plans to see how well they comport with the principles outlined in the letter. As you will see, the data show that most companies are following the principles. We believe that this analysis, coupled with the enclosed status report on the actual amount of proposed new testing that we briefly highlighted for you at last week's meeting, provide a clear indication that companies also take the principles outlined in the October 14 letter seriously and are, for the most part, complying with the goals of the HPV Challenge Program.

Adjusting the Use of the Comment Period

As part of the program, EPA is committed to reviewing and posting comments to the test plans before or on day 120. We feel strongly that this remain a fundamental component of the program. Since almost all of PCRM/PETA's comments to the test plans have come in within a day or two of the 120th day, it is clear that EPA has not reviewed them prior to completing our comments. EPA had envisioned that comments would come in earlier in the process so that they could be reviewed and, where appropriate, taken into account in the development of our comments. We do appreciate the issue you raised, however, about industry statements regarding a hesitancy to revise plans once EPA has "blessed" the plan. We will strongly urge companies to consider all comments received on their test plans as they revise and finalize their plans for filling the gaps in data on these chemicals.

Funding for Alternatives

As you are aware, $500,000 in ORD funds were placed into an Interagency Agreement with NIEHS to support activities related to the development of non-animal alternatives. As we discussed at the meeting, Bill Sanders will work with ORD and NIEHS so that we can fully respond to your request and provide a final accounting of these expenditures. He will provide you with additional information as soon as possible.

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