* Preventive controls for hazards that are reasonably likely to occur;
* Corrective actions;
* Verification; and
* Associated records.
The application of the preventive controls would be required only in cases where facilities determine that hazards are reasonably likely to occur. The Agency does not expect that all possible preventive measures and verification procedures would be applied to all animal foods at all facilities.
The proposed rule would also establish a series of exemptions (including modified requirements in some cases) from the requirements for hazard analysis and preventive controls. Facilities that manufacture, process, pack, or hold animal food and that are required to register with
Proposed Exemptions From the New Requirements for Hazard Analysis and Risk-Based Preventive Controls Who or what would be exempt from the Notes requirements for hazard analysis and risk-based preventive controls "Qualified Facility" as defined by
FDAis proposing three options for FSMA defining "very small business" and . Business with average annual sales requests comment on which to adopt in of < $500,000and at least half the a final rule. sales to consumers or local retailers Modified requirements would or restaurants (within the same state apply--i.e., a qualified facility or within 275 miles); or would be required to: . Very small business . Notify FDAabout its status; and ○ Option 1: Total annual sales of . Either: < $500,000○ Notify FDA that it is addressing ○ Option 2: Total annual sales of hazards through preventive controls < $1,000,000and monitoring; or ○ Option 3: Total annual sales of ○ Notify FDA that it complies with < $2,500,000applicable local regulations, and notify consumers of the name and complete business address of the facility where the animal food was manufactured or processed. . Low risk, on farm activities Small and very small on-farm performed by a small business (<500 businesses conducting these low risk employees): or activities would be exempt from most . Low-risk, on-farm activities of the rule's requirements. performed by a very small business The Agency would define the low-risk ○ Option 1: very small = activities that qualify for the < $500,000exemption, including the specific ○ Option 2: very small = foods to which they relate (such as < $1,000,000re-packing intact fruits and ○ Option 3: very small = vegetables, or < $2,500,000grinding/milling/cracking/crushing grains). Activities that are subject to the . The exemption applies only with "low-acid canned food" requirements of respect to microbiological hazards. S. 500.23 (21 CFR 500.23) and part 113 . The facility must be in compliance (21 CFR part 113) with part 113. Activities of a facility that are Published in the Federal Registersubject to section 419 of the FD&C Act January 16, 2013(78 FR 3504). (21 U.S.C. 350h) (Standards for Produce Safety) Facilities that are solely engaged in A facility that stores raw the storage of raw agricultural agricultural commodities that are commodities (other than fruits and fruits or vegetables would not be vegetables) intended for further exempt. distribution or processing Facilities solely engaged in the Modified requirements would apply for storage of packaged animal food that the storage of refrigerated packaged is not exposed to the environment animal food.