Food Safety - What To Expect

Notification, Documentation and Record-keeping Requirements for Inspected Establishments

CI: Our readers are generally small and medium business involved in food and beverage manufacturing and getting those products to market.    They are generally busy doing what they do best - producing product for their customers.    Can you tell us briefly, what they should be prepared to expect in terms of new laws and regulations?    

Neil: The proposed rule would implement a provision of the 2008 Farm Bill and is a priority for the Food Safety Working Group (FSWG). President Obama called on government to do more to ensure our food is safe, and FSIS is working aggressively every day to improve the food safety system in the United States. The steps being taken will help prevent foodborne illness as well as speed our response when illnesses occur – two goals of FSWG.

There are three issues that may apply to your customers.

First, under the Federal Meat Inspection Act and the Poultry Products Inspection Act, FSIS is responsible for ensuring that the nation’s food supply of meat and poultry is safe, not adulterated, wholesome, and properly marked, labeled, and packaged.  The Federal meat and poultry products inspection regulations have provisions that address the receipt of adulterated or misbranded products by an official establishment or consignee under specific circumstances. In "Notification, Documentation, and Record-keeping Requirements for Inspected Establishments,” posted on March 25, 2010, FSIS is proposing that official establishments promptly notify the appropriate FSIS District Office that an adulterated or misbranded product received by or originating from the establishment has entered commerce, if the establishment believes or has reason to believe that this has happened. FSIS is also proposing that the establishment inform the FSIS District Office of the type, amount, origin, and destination of the adulterated or misbranded product.  

Second, the proposed rule would make it mandatory for Federally inspected establishments to develop up-to-date recall plans.

Third, any reassessments of an official establishment’s Hazard Analysis and Critical Control Point (HACCP) plan would have to be documented. An explanation would be required for why any changes were made or not made to the HACCP plan.  

For further information, see the Federal Register Posting at:

http://www.fsis.usda.gov/Frame/FrameRedirect.asp?main=http://www.fsis.usda.gov/OPPDE/rdad/FRPubs/2008-0025.htm.


Note:  The proposed rule only impacts the meat and poultry industry. The beverage industry would not be implicated in the proposed rule, because it is under FDA’s jurisdiction.

CI: What is the best educated guess, at this point on when the new regulations might take effect?

FSIS: We do not have a specific date when the new regulations might take effect, since the Agency is at the stage of soliciting comments at this time.  FSIS will receive comments on the rule proposals through May 24, 2010.

CI: Some of the discussion of small businesses is the proposed cost increases to their business.   Can you make any comment on what might be discussed right now in terms of additional financial cost to a small business (or any possible cost savings?)

FSIS: While there will be costs to develop recall plans and maintain records, FSIS expects that they will be minimal.    Many establishments have recall plans in place which are outlined in FSIS’ Directive 8080.1 at http://www.fsis.usda.gov/OPPDE/rdad/FSISDirectives/8080.1Rev5.pdf.

By having a recall plan in place, Federally inspected establishments ultimately recognize a cost savings due to the impact a recall can have on small and very small plants. FSIS regulation helps prevent misbranded or adulterated products entering into commerce for the human food supply. This rule however is intended to get on top of a situation if something should enter commerce and limit the public health risk.

CI: What advice can you offer businesses so that they are well prepared to transition to new requirements?   

FSIS:  Establishments should submit comments on the proposed rule before May 24, 2010 to the Office of Policy and Program Development and look for the publication of a final rule in the Federal Register. We encourage people to sign up to receive our email subscription alerts for  press releases, Federal Register publications and more on the FSIS site at: http://www.fsis.usda.gov/News_&_Events/Email_Subscription/index.asp.

Current information on the recall process may serve as another resource for establishments to learn the requirements outlined by the Federal Register. This information is on the FSIS site at: http://www.fsis.usda.gov/regulations_&_policies/Directives/index.asp

Establishments may also receive information from AskFSIS for more specific questions on the FSIS site at:

http://askfsis.custhelp.com/cgi-bin/askfsis.cfg/php/enduser/std_alp.php?p_sid=AUKzwfYj”

CI: What resources are available to small business to keep up with pending policies or legislation as it relates to food safety?

FSIS: FSIS’s Small Plant Help Desk serves as a "one-stop shop” for operators of small plants. Inquiries can be made to the Small Plant Help Desk at 1-877-FSISHelp (877-374-7435) or by e-mailing InfoSource@fsis.usda.gov. The help desk is open from 8:00 a.m. to 4:00 p.m. ET, Monday through Friday.  FSIS Small Plant Help Desk staff assist callers seeking help with agency requirements relating to the regulation of meat, poultry and processed egg products, provide information and guidance materials, and direct them to other FSIS services, such as AskFSIS, the agency's existing Internet service offering official responses to inquiries on agency policy, which can be accessed at www.fsis.usda.gov.

The Small Plant Help Desk also supports USDA's "Know Your Farmer, Know Your Food" initiative by helping small processors reduce the time and expense of dealing with agency requirements. More information on the "Know Your Farmer, Know Your Food" initiative can be found at www.usda.gov/knowyourfarmer. For more information on FSIS’ Small Plant Help Desk, go to http://www.usda.gov/wps/portal/usdahome?contentidonly=true&contentid=2009/12/0601.xml

FSIS Directive 8080.1 explains the recall process requirements and in an appendix provides guidance on recall plans at http://www.fsis.usda.gov/OPPDE/rdad/FSISDirectives/8080.1Rev5.pdf.


FSIS has conducted webinars and podcast series on new regulations and the recall process. These are available on the FSIS site at:

http://www.fsis.usda.gov/News_&_Events/Food_Safety_Inspection_Podcasts/index.asp

FSIS will conduct outreach to small and very small plants once a final rule is issued. Further information will be available at that time and can be accessed at www.fsis.usda.gov or by contacting the Small Plant Help Desk.



About the Food Safety Inspection Service:

FSIS is the public health agency in the U.S. Department of Agriculture responsible for ensuring that the nation's commercial supply of meat, poultry, and egg products is safe, wholesome, and correctly labeled and packaged. In fulfilling its mission, the Agency is enhancing and strengthening the nation’s food safety system.”