; or (2) to enforce laws of general applicability, such as zoning laws, environmental laws, labor laws, and general business laws. (c) Clarification This section shall not be construed to shift liability to health care practitioners or other users. 587V. Adulteration An in vitro clinical test shall be deemed to be adulterated: (1) If it consists in whole or in part of any filthy, putrid, or decomposed substance. (2) If it has been developed, prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health. (3) If its container or package is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health. (4) If it bears or contains, for purposes of coloring only, a color additive which is unsafe within the meaning of section 721(a). (5) If its analytical or clinical validity, or with respect to a specimen receptacle, its safety, or its strength, purity, or quality, differs from or falls below that which it purports or is represented to possess. (6) If it is required to be, declared to be, purports to be, or is represented as being, in conformity with any performance standard established or recognized under section 587Q and is not in all respects in conformity with such standard. (7) If it is required to be in conformity with a mitigating measure established under section 587E and is not in all respects in conformity with such mitigating measure. (8) If it fails to have an approved premarket application under section 587B unless such in vitro clinical test can be lawfully offered— (A) for clinical use pursuant to an exemption under section 587A; (B) for emergency use pursuant to an authorization under section 564