Proposed SEC 507.3 defines "qualified facility" to mean (when including the sales by any subsidiary; affiliate; or subsidiaries or affiliates, collectively, of any entity of which the facility is a subsidiary or affiliate) a facility that is a very small business as defined in this part, or a facility as to which both of the following apply:
* During the 3-year period preceding the applicable calendar year, the average annual monetary value of the animal food manufactured, processed, packed, or held at such facility that is sold directly to qualified end-users (as defined in this part) during such period exceeded the average annual monetary value of the animal food sold by such facility to all other purchasers; and
* The average annual monetary value of the animal food sold during the 3-year period preceding the applicable calendar year was less than
This definition is based on the criteria in section 418(l)(1) of the FD&C Act. The Agency is specifying "animal food" in this definition as it intends to only include the sale of food for animals and not the sale of human food in determining whether a facility meets the requirements in those cases where a facility sells both. The Agency requests comment on whether food for animals and humans should be aggregated in determining whether a facility that sells both meets the statutory criteria of a qualified facility.
Proposed SEC 507.3 defines "qualified individual" to mean a person who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by
Proposed SEC 507.3 defines "quality control operation" to mean a planned and systematic procedure for taking all actions necessary to prevent food from being adulterated.
Proposed SEC 507.3 defines "reasonably foreseeable hazard" "to mean a potential biological, chemical, physical, or radiological hazard that may be associated with the facility or the food. This term is used in FSMA and the concept is grounded in the hazard evaluation process in HACCP systems.
Proposed SEC 507.3 defines "rework" to mean clean, unadulterated food that has been removed from processing for reasons other than insanitary conditions or that has been successfully reconditioned by reprocessing and that is suitable for use as animal food.
Proposed SEC 507.3 defines "safe moisture level" as a level of moisture low enough to prevent the growth of undesirable microorganisms in the finished product under the intended conditions of manufacturing, processing, packing, and holding. The safe moisture level for food is related to its water activity (aw). An aw will be considered safe for a food if adequate data are available that demonstrate that the food at or below the given aw will not support the growth of undesirable microorganisms.
Proposed SEC 507.3 defines "sanitize" to mean to adequately treat cleaned food-contact surfaces by a process that is effective in destroying vegetative cells of microorganisms of animal and human health significance, and in substantially reducing numbers of other undesirable microorganisms, but without adversely affecting the product or its safety for animals or humans. For example, an appropriate sanitizing process for a facility that manufactures, processes, packs or holds animal food can be one that does not cause illness to the person implementing it and does not make the food unsafe for the intended animal species, person handling the food or humans consuming human food derived from animals that consume the animal food. It is well established that sanitizers can be inactivated by organic material and, thus, are not effective unless used on clean surfaces (Ref. 35). The Agency recognizes that in certain situations effective cleaning and sanitizing of food-contact surfaces for animal food helps protect the health of animals by controlling the transmission of animal diseases. Effective cleaning and sanitizing of food-contact surfaces for animal food can also protect human health by preventing transmission of human diseases that occur through handling of the contaminated food.
Most Popular Stories
- Obamacare Doing Just Fine, Ky. Governor Says
- Twitter Names Woman to Board
- Rand Paul Signs up for Obamacare
- Aspen Contracting Adding 300 Jobs
- Hispanic Employment Improves in November
- U.S. Chamber to Run Ads in Idaho, W.Va.
- Trapped Florida Whales Head for Deeper Waters
- U.S. Unemployment Rate Dips to 7 Percent
- Consumer Spending Rises, Incomes Fall
- American Eagle Issues Weak Q4 Outlook