| FDA Food Safety Modernization Act - 2010 |
On December 19, 2010, the congressional record published a proposed amendment to the Food Drug and Cosmetic Act (21 U.S.C. 301 et seq., titled as the "FDA Food Safety Modernization Act". As of today, December 31, 2010, the bill representing the changes to the FDCA has passed both houses of Congress and is on its way for signature by the President.
The final version of the bill is available on this website. It is a difficult to read and not a pleasant reading experience for most individuals. If you or your company operates a facility subject to registration under Section 415 of the FDCA, then you should look over this new law, because you're going to be impacted by its requirements.
If you wish to learn more about the new law, click on one of the following links: (1) to read a copy of the law lifted directly from the Congressional Record, or (2) Q&As about the new regulation. Please note, when reading the law, the content you'll probably want to start with begins on page S10745 with the heading SA 4890 and continues through page S10770. We think of the bill as being organized into 4 major sections, called "TITLES". These are as follows:
Title I - Improving Capacity To Prevent Food Safety Problems
Title II - Improving Capacity To Detect and Respond To Food Safety Problems
Title III - Improving The Safety Of Imported Food
Title IV - Miscellaneous
The majority of readers working for growers and packhouses, food processing, ingredient supply and distribution facilities will find they get the most from Title I and Title II. Title I, Section 418 is notably important since it will require all facilities within the U.S. food supply chain to perform and document (written records) a risk assessment (HACCP plan) based upon the products they are handling or processing. Records that document how you performed the risk assessment, together with preventive controls must be made available during routine FDA facility audits.
While there are provisions for exemptions from Sec. 418, these exemptions seem to be very narrow and related to very small facilities. It is advisable that you or a company representative get suitable legal advice before a presumption is made regarding any possible exemptions to the requirements of this bill.
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