Professional Services in Toxicology


James R. Beall

Tips to facilitate Labeling of Hazardous Art Materials (LHAMA) Certifications

Inadequate or missing information can delay the certification process. To facilitate LHAMA certification, it is important to provide the toxicologist with accurate information at the start of the certification process. The information should describe each ingredient in, and the complete formulation of, the art material. LHAMA regulations constrain the toxicologist from divulging proprietary information.

The following information added to your submission to the toxicologist should help facilitate the certification:

1) For each ingredient in the art material, include the standard internationally recognized chemical name of the ingredient and its Chemical Abstract Number (CAS), and Color Index (C.I.) number of colorants.

2) Include the amount by weight or percentage of each ingredient in the total formulation of the art material.

3) Summarize the market history, if any, of the art material and whether it has resulted in health-related customer complaints (if so, the nature of the complaints).

4) Include results of all heavy metal analyses of individual ingredients and the formulation, and

5) Include relevant Material Safety Data Sheets (MSDS) for each of the ingredients. Because MSDS sheets may not include proprietary ingredients in a product, that information alone may be inadequate for a LHAMA certification.

Also it is helpful to accurately and completely identify the art material by including the full, and complete name of: 1) the Producer and/or Repackager of the art material, 2) the distributor of the art material, if known, and 3) the specific product name and identifying number for the art material.

Providing the certifying toxicologist with this information before the review is undertaken should facilitate the LHAMA review and certification, and help assure that the certification report is completed promptly and accurately.

Regulatory Background of LHAMA, and Requirements of the Toxicologist

The American Society for Testing and Materials (ASTM) practice D-4236-88 as incorporated into 16 CFR Part 1500.14 (b)(8)(i)(B)(11) defines a toxicologist as "an individual who through education, training, and experience has expertise in the field of toxicology, as it relates to human exposure, and is either a toxicologist or physician certified by a nationally recognized certification board."

These regulations require that, "The producer or repackager shall submit art material product formulation(s) or reformulation(s) to a toxicologist for review, such review be in accordance with paragraph (b)(8)(1)(D)" of 16 CFR 1500.14.

In evaluating the chronic hazard of the art material, the toxicologist is to take into account:
1) the chemical composition of the art material,
2) the scientific knowledge of each component and the total formulation,
3) the physical and chemical form of the product, bioavailability, concentration, and the amount of each potentially chronic toxic component in the formulation,
4) reasonable foreseeable uses of the art material product as determined by consultation with teachers, and other individuals who are experienced in use of the material(s),
5) potential for known synergism and antagonism of the various components in the formulation,
6) potentially chronic adverse health effects of decomposition or combustion products, if known, from any reasonably foreseeable use of the hazardous art material product, and
7) opinions of various regulatory agencies and scientific bodies concerning the components and the product.

Based upon the conclusions reached as conformance with review determinations the toxicologist(s) shall recommend precautionary labeling that is consistent with that set forth by the standard.

Official CPSC information about LHAMA.

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"Professional Services in Matters of Toxicology and Health Research"

Updated 1 July 97