Allegation of significant adverse effect

For example, raste from pharmaceutical manufacturing plants is regulated under TSCA, and allegations of significant adverse effects caused by a pharmaceutical plant waste would have to be recorded under 8(c) of TSCA. See Chapter 7, Reporting and Recordkeeping. 

They also require maintaining records of allegations of significant adverse effects. The major recordkeeping and reporting requirements in TSCA 8 are ... 

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... 

Significant Adverse Reaction 40 CFR 717 Record of new allegation that chemical substance or mixture caused significant adverse effect for health or the environment TSCA 8(c)... 

Regulatory. Aspartame is permitted across the world in all major markets. It has an ADI of 40 mg/kg bw, which is significantly higher than other sweeteners. It is ironic that, historically, this sweetener has been the subject of allegations about adverse health effects. Evidence put forward has been largely anecdotal and picked up and promoted via the internet or the lay press. Scientifically controlled peer-reviewed studies have consistently failed to link aspartame consumption, even of abuse levels, to adverse health effects. The most recent review, of over 500 studies and reports about aspartame conducted by the Scientific Committee on Food (SCF), concluded that... 

---