02-13767. Availability of Draft Guidance Manual and Draft Interaction Profiles

AGENCY:

Agency for Toxic Substances and Disease Registry (ATSDR), Department of Health and Human Services (HHS).

ACTION:

Notice of availability.

SUMMARY:

This notice announces the availability of a draft guidance manual and six draft interaction profiles prepared by ATSDR for review and comment.

DATES:

To ensure consideration, comments on these draft documents must be received on or before September 2, 2002. Comments received after the close of the public comment period will be considered at the discretion of ATSDR based upon what is deemed to be in the best interest of the general public.

ADDRESSES:

Requests for copies of the draft interaction profiles should be sent to the attention of Ms. Franchetta Stephens, Division of Toxicology, Agency for Toxic Substances and Disease Registry, Mailstop E-29, 1600 Clifton Road, NE, Atlanta, Georgia 30333.

Requests for the draft interaction profiles must be in writing, and must specifically identify the interaction profile(s) that you wish to receive. The documents will be primarily available in electronic Adobe Acrobat (pdf) files. If you do not have a computer, you can ask for a hard copy. ATSDR reserves the right to provide only one copy of each profile requested, free of charge. In case of extended distribution delays, requestors will be notified.

Interaction profiles and the guidance manual will also be available on ATSDR's Web site at http://www.atsdr.cdc.gov.

Written comments and other data submitted in response to this notice and the draft interaction profiles or draft guidance document should bear the docket control number ATSDR-182. Send one copy of all comments and three copies of all supporting documents to Dr. Hana Pohl, ATSDR, Division of Toxicology, Mailstop E-29, 1600 Clifton Road, Atlanta, Georgia 30333 by the end of the comment period. Because all public comments regarding ATSDR interaction profiles and the guidance manual are available for public inspection after they are published in final, no confidential business information or other confidential information should be submitted in response to this notice.

FOR FURTHER INFORMATION CONTACT:

Ms. Franchetta Stephens, Division of Toxicology, Agency for Toxic Substances and Disease Registry, Mailstop E-29, 1600 Clifton Road, NE, Atlanta, Georgia 30333, telephone [phone] or [phone].

SUPPLEMENTARY INFORMATION:

The Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA) mandates that the Agency for Toxic Substances and Disease Registry (ATSDR) shall assess whether adequate information on health effects is available for the priority hazardous substances. Where such information is not available or under development, ATSDR shall, in cooperation with the National Toxicology Program, initiate a program of research to determine these health effects. The Act further directs that where feasible, ATSDR shall develop methods to determine the health effects of substances in combination with other substances with which they are commonly found. The Food Quality Protection Act (FQPA) of 1996 requires that factors to be considered in establishing, modifying, or revoking tolerances for pesticide chemical residues shall include the available information concerning the cumulative effects of substances that have a common mechanism of toxicity, and combined exposure levels to the substance and other related substances. The FQPA requires that the Administrator of the Environmental Protection Agency consult with the Secretary of the Department of Health and Human Services (which includes ATSDR) in implementing some of the provisions of the act.

To carry out these legislative mandates, ATSDR has developed a chemical mixtures program. As part of the mixtures program, ATSDR developed a guidance manual that outlines the latest methods for mixtures health assessment. In addition, a series of documents called interaction profiles are being developed for certain priority mixtures that are of special concern to ATSDR. The purpose of an interaction profile is to evaluate data on the toxicology of the “whole” priority mixture (if available) and on the joint toxic action of the chemicals in the mixture in order to recommend approaches for the exposure-based assessment of the potential hazard to public health.

Although key studies for each of the mixtures were considered during the profile development process, this Federal Register notice seeks to solicit any additional studies, particularly unpublished data and ongoing studies, which will be evaluated for possible addition to the profiles now or in the future.

The following draft documents will be available to the public on or about, June 1, 2002.

Document 1

Guidance manual for the assessment of joint toxic action of chemical mixtures.

Document 2

Interaction profiles for persistent chemicals found in fish. Chlorinated dibenzo-p-dioxins (CDDs), hexachlorobenzene, dichlorodiphenyl dichloroethane (p,p'-DDE), methyl mercury, and polychlorinated biphenyls (PCBs).

Document 3

Interaction profiles for persistent chemicals found in breast milk. Chlorinated dibenzo-p-dioxins (CDDs), hexachlorobenzene, dichlorodiphenyl dichloroethane (p,p'-DDE), methyl mercury, and polychlorinated biphenyls (PCBs).

Document 4

Interaction profile for 1,1,1-trichloroethane, 1,1-dichloroethane, trichloroethylene, and tetrachloroethylene.

Document 5

Interaction profile for benzene, ethylbenzene, toluene, and xylenes (BTEX).

Document 6

Interaction profile for arsenic, cadmium, chromium, and lead.

Document 7

Interaction profile for copper, lead, manganese, and zinc.

All documents issued as “Drafts for Public Comment” represent ATSDR's best efforts to provide important toxicological information on interactions of priority hazardous substances. We are seeking public comments and additional information which may be used to supplement these documents. ATSDR remains committed to providing a public comment period for these documents as a means to best serve public health and our clients.

Dated: May 24, 2002.

Georgi Jones,

Director, Office of Policy and External Affairs, Agency for Toxic Substances and Disease Registry.