04-27954. Availability of a Guidance Manual for the Assessment of Joint Toxic Action of Chemical Mixtures and Nine Interaction Profiles CD-ROM [Final Documents] and Two Interaction Profiles [Drafts for Public Comments]

AGENCY:

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

ACTION:

Notice of availability.

SUMMARY:

This notice announces the availability of the Guidance Manual for the Assessment of Joint Toxic Action of Chemical Mixtures and nine interaction profiles CD-ROM prepared by ATSDR [final documents]. This notice also announces two additional interaction profiles that will be released as drafts for public comments.

DATES:

The Guidance Manual and nine interaction profiles were included on the ATSDR ToxProfiles 2004 ^TM including ToxFAQs ^TM CD-ROM released in October 2004. The two additional interaction profiles [drafts for public comments] will be available on January 1, 2005. The comment period for the two additional profiles will be from January 1, 2005 to March 31, 2005.

ADDRESSES:

Written requests for the CD-ROM should be sent to the attention of Ms. Yulandia Jordan, Office of Communication, Agency for Toxic Substances and Disease Registry, Mailstop E-29, 1600 Clifton Road, NE., Atlanta, Georgia 30333 or by e-mail to [e-mail].

Requests for the guidance manual and/or interaction profiles must be in writing and submitted to the address mentioned above. ATSDR reserves the right to provide only one copy free of charge.

In case of extended distribution delays, requesters will be notified.

The documents will be also available on ATSDR's Web site at http://www.atsdr.cdc.gov.

FOR FURTHER INFORMATION CONTACT:

Please send comments or questions regarding information contained in the profiles to Dr. Hana Pohl, Division of Toxicology, Agency for Toxic Substances and Disease Registry, Mailstop F-32, 1600 Clifton Road, NE., Atlanta, Georgia 30333, telephone [phone].

SUPPLEMENTARY INFORMATION:

Six of the interaction profiles were developed by ATSDR for hazardous substances at the National Priority List (NPL) sites and three interaction profiles were developed by ATSDR for the hazardous substances at the Department of Energy (DOE) and National Aeronautics and Space Administration (NASA) waste sites under Section 104(i)(3) and (5) of the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA). This public law mandates that 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.

All the documents were submitted to both the peer-review and the public review processes. Changes in the documents reflect those addressing reviewers' comments.

The following documents were made available to the public in October 2004.

Document 1

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

Document 2

Interaction profile 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 profile 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.

Document 8

Interaction profile for cesium, cobalt, polychlorinated biphenyls, strontium, and trichloroethylene.

Document 9

Interaction profile for arsenic, hydrazines, jet fuels, strontium, trichloroethylene.

Document 10

Interaction profile for cyanide, fluoride, nitrate, and uranium.

Two additional Interaction Profiles [Drafts for Public Comments]

Interaction profile for atrazine deethylatrazine, diazinon, simazine, and nitrate.

Interaction profile for chlorpyrifos, lead, mercury, and methylmercury.

Dated: December 16, 2004.

Georgi Jones,

Director, Office of Policy, Planning, and Evaluation, National Center for Environmental Health and Agency for Toxic Substances and Disease Registry.