TSCA 8 c Recordkeeping—Allegations of Significant Adverse Reactions

TSCA 8(c) Recordkeeping—Allegations of Significant Adverse Reactions 

TSCA 8(c) requires that any person who manufactures, processes, or distributes in commerce any chemical substance or mixture must maintain records of significant adverse reactions to health and the environment. Such allegations do not have to be disclosed or reported to EPA unless the Agency requests them. Allegations made by employees, i.e., those allegations that relate to occupational exposure, must be maintained for thirty years. Ah other allegations must be maintained for five years. 

The recordkeeping obligation of TSCA 8(c) provides a means to identify previously unknown chemical hazards by revealing patterns of adverse effects that might otherwise go undetected.  

Manufacturers, importers, and some processors and distributors are subject to TSCA 8(c). The statutory language broadly applies TSCA 8(c) to all manufacturers, processors, and distributors of a chemical substance, and importers are also included because the term manufacture is defined in the TSCA statute to include import. EPA s regulations implementing this subsection create several exemptions to the statute s broad scope of coverage. Distributors who do not also manufacture or process the chemical substances are defined as sole distributors and are exempt. Retailers are also exempt provided that they distribute to ultimate customers that are not commercial entities and provided that they do not also manufacture or process the subject chemicals.  

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The essence of TSCA 8(c) is recordkeeping and a firm subject to the requirements of this rule is required to establish and maintain records of significant adverse reactions alleged to have been caused by chemical substances or mixtures manufactured or processed by the firm. All records are to be maintained together at the firm s headquarters or any such other appropriate location central to the firm s chemical operations. ... 

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 recordkeeping 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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