Allegations of Significant Adverse Reactions

Under TSCA Section 8(c), companies can be required to record, retain and in some cases report "allegations of significant adverse reactions" to any substance/mixture that they produce, import, process, or distribute. EPA's TSCA Section 8(c) rule requires producers, importers, and certain processors of chemical substances and mixtures to keep records concerning significant adverse reaction allegations and report those records to EPA upon notice in the Federal Register or upon notice by letter. The TSCA Section 8(c) rule also provides a mechanism to identify previously unknown chemical hazards in that it may reveal patterns of adverse effects which otherwise may not be otherwise noticed or detected. Further information available under 40 CFR Part 717.

An "Allegation" is defined as "a statement, made without formal proof or regard for evidence, that a chemical substance or mixture that a chemical substance or mixture has caused a significant adverse reaction to health or the environment."

"Significant adverse reactions" are defined as "reactions that may indicate a substantial impairment of normal activities, or long lasting or irreversible damage to health or the environment."

Any person can make a written or verbal allegation. Verbal allegations must be transcribed either by the company or the individual making the allegation (if transcribed by the individual, they must be signed). To be recordable, allegations must implicate a substance that caused the reaction by naming either the specific substance, a mixture or article containing the substance, or a company process in which substances are involved, or identifying a discharge from a site of manufacture, processing, or distribution of the substance.

Examples of significant adverse reactions include:

long-lasting or irreversible damage to human health
partial or complete impairment of bodily functions
impairment of normal activity by all/most persons exposed at one time/each time an individual is exposed
gradual or sudden changes to animal or plant life in a given geographic area
abnormal numbers of deaths/changes in behavior or distribution of organisms
long lasting or irreversible contamination of the physical environment

Allegations that are "exempt" from the requirements of the TSCA Section 8(c) rule include:

those alleging "known human effects"
allegations involving adverse reactions to the environment if the alleged cause can be directly attributable to an incident of environmental contamination that has already been reported to the U.S. Government under any applicable authority
anonymous allegations

TSCA Section 8(c) records must be kept at a company's headquarters or at a site central to their chemical operations. The record must contain the following information:

the original allegation as received
an abstract of the allegation
the results of any self-initiated investigation regarding the allegation
copies of any further required information regarding the allegations (e.g., copies of any reports required to be made to the U.S. Occupational Safety and Health Administration)

TSCA Section 8(c) records must be retrievable by the alleged cause of the reaction (i.e., specific chemical identity, mixture, article company process or operation, or site emission, effluent, or discharge).

An allegation made by an employee must be kept by the company for 30 years by the company while all other allegations (e.g., those made by plant site neighbors or customers) must be kept by the company for 5 years.

Allegations of Significant Adverse Reactions

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