specified period of time to assess the risks to health or the environment. Failure to do so can result in penalties as high as $25,000 per day of violation. It should be noted that importation is the same as manufacturing under TSCA.

There is an exemption from the PMN requirement for chemicals used for R&D, or in a use regulated by another agency (such as solely for medical use regulated by FDA), but EPA still considers R&D use to be a commercial activity. There are significant personnel notification and record-keeping requirements under this exemption (R&D Exemption: 40 CFR 720.3, 720.36, and 720.78).

The following is a summary of TSCA rules concerning R&D exemption requirements:

  1. Operation under the R&D exemption requires notification in writing to those who may be exposed to the exempt substance. However, R&D conducted solely in R&D laboratories results in minimal requirements. New substances for which no hazard information is available need only carry the appropriate labels.

  2. All containers of R&D-exempt material or of mixtures containing the material should have an experimental material label and a TSCA R&D label. While EPA does not specify the language, the following is an example of a TSCA R&D label:

    This material is not listed on the TSCA Inventory. It should be used for research and development purposes only under the direct supervision of a technically qualified individual.

  3. On any Material Safety Data Sheet (MSDS) in the "composition, information on ingredients" section for an R&D-exempt material, words to the following effect should be indicated:

    This material is for R&D evaluation only. It can only be used for R&D evaluations until PMN review by EPA is completed. If this material is used in plants or non-R&D locations for R&D evaluation, its use must be supervised by a technically qualified individual. Review all sections of this MSDS prior to use.

  4. If an R&D-exempt material leaves a "prudent laboratory practices" area-e.g., if a sample is sent to a customer or the material is used in a pilot plant or manufacturing plant-you must provide written notification to those exposed to the substance.

  • Your notification must inform users of any information in your possession or control on the risk to health from such exposure, or must state that no information is known about the toxicity of the substance.

  • You should request a review of health studies or EPA actions on the R&D material by your laboratory's toxicologist and maintain a record of the response. The adequacy of the notification(s) is the responsibility of the manufacturer or importer, and copies of such notice(s) must be kept for 5 years.

  1. A checklist for R&D samples sent to plants or outside processors would include:

  • shipping the material with

    • appropriate experimental material and TSCA R&D container labels affixed, and

    • an enclosed copy of the MSDS.

  • providing a letter to each recipient that indicates

    • any known hazard information,

    • that the substance is solely for R&D purposes, and

    • that use of the substance requires supervision by a technically qualified individual.

  • maintaining a record of

    • names and addresses of sample recipients,

    • sample identification code,

    • amount of material, and

    • purpose of the sample.

      Copies of the written notifications provided (i.e., the letter, the MSDS, and copies of all labels affixed to sample containers) should be maintained in a file for 5 years (40 CFR 720.78, Record-keeping).

  1. EPA did not set exact quantities for R&D exemption volumes. The EPA standard is "not greater than reasonably necessary for such (R&D) purposes." Let that serve as your standard for R&D-stage activities, with the understanding that you are in the best position to determine what reasonable R&D volumes are, given the technology and product development requirements for making and processing a particular material for your R&D needs. Note that stockpiling of R&D material for later manufacturing is prohibited if the material is not on the TSCA Inventory.

9.G.2 Record-keeping Requirements for Significant Adverse Reaction Allegations--TSCA 8(C)

One subpart of Section 8 of TSCA can affect R&D laboratories. TSCA 8(c) is the requirement to keep records of allegations of significant adverse effects of chemicals. The allegations need not be proved to be subject to this record-keeping requirement. If a worker becomes aware of an allegation of a significant adverse reaction to a chemical (e.g., a skin rash, an allergic reaction, respiratory effects), he or she should contact the supervisor or the health, safety, and environmental

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