Executive summary: preventive controls rule

01/10/2013 03:21:00 PM
Tom Karst

• Option 3: Average annual sales of <$1,000,000


FDA is proposing three options for defining “very small business” and requests comment on which to adopt in a final rule.

Modified requirements would apply - i.e., a qualified facility would be required to:

• Notify FDA about its status; and

• Either:

o Notify FDA that it is addressing hazards through preventive controls and monitoring;


o Notify FDA that it complies with applicable local regulations, and notify consumers of the name and complete business address of the facility where the food was manufactured or processed.

• Low risk, on farm activities performed by small business (< 500 employees)


• Low-risk, on-farm activities performed by a very small business

o Option 1: very small = <$250,000

o Option 2: very small =<$500,000

o Option 3: very small = <$1,000,000

Small and very small on-farm businesses conducting these low risk activities would be exempt from most of the rule’s requirements. We would define the low-risk activities that qualify for the exemption, including the specific foods to which they relate (such as re-packing intact fruits and vegetables, or grinding/milling/cracking/crushing grains)

Activities that are subject to the seafood HACCP requirements of part 123 (21 CFR part 123)

The facility must be in compliance with part 123.

Activities that are subject to the juice HACCP requirements of part 120 (21 CFR part 120)

The facility must be in compliance with part 120. Activities that are subject to the “low-acid canned food” requirements of part 113 (21 CFR part 113)

• The exemption applies only with respect to microbiological hazards.

• The facility must be in compliance with part 113.

The manufacturing, processing, packing, or holding of a dietary supplement that is subject to the CGMP requirements of part 111 (21 CFR part 111)

• The facility must be in compliance with part 111.

• The facility must be in compliance with requirements for serious adverse event reporting for dietary supplements Activities of a facility that are subject to section 419 of the FD&C Act (Standards for Produce Safety)

 Elsewhere in this issue of the Federal Register, FDA is proposing standards for produce safety.

 Who or What Would Be Exempt From the Requirements for Hazard Analysis and Risk- Based Preventive Controls


Alcoholic beverages at a facility that is required to obtain a permit from, register with, or obtain approval of a notice or application from the Secretary of the Treasury as a condition of doing business in the United States The exemption also would apply to food other than alcoholic beverages at such a facility, provided that the food is in prepackaged form and constitutes not more than 5 percent of the overall sales of the facility.

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