Cardinals!WBFI Regulatory News:
FDA defines Domestic Facility Risk Categorization
March 12, 2012
FDA uses its website to provide information on the implementation of the Food Safety Modernization Act (FSMA).
  • From their homepage in the link you see on this page,
  • Locate the box on the right that says FDA Initiatives.
  • Click on Food Safety.

You will then go to their FSMA page, and the link to sign up for email updates is found in the box at the top of the page.

 

If you have not signed up to receive notices, you may want to do so now in order to keep in touch with what's being released. The law will take effect on July 4, 2012 whether or not FDA has published all the rules and regulations. As we get closer to that date, we may lose the opportunity to comment on the rules because they will take effect as soon as they are issued.
FDA issues new Q&A on High Risk (HR) facilities 
This is the link to the FDA's explanation of how a High Risk (HR) facility is identified in comparison to a Non-High Risk (NHR) facility. The FDA is utilizing a decision-making process based on the risk factors identified in section 421(a)(1) of the FD&C Act, which are:
  1. The known safety risks of the food manufactured, processed, packed, or held at the facility;
  2. The compliance history of a facility, including with regard to food recalls, outbreaks of foodborne illness, and violations of food safety standards;
  3. The rigor and effectiveness of the facility's hazard analysis and risk-based preventive controls;
  4. Whether the food manufactured, processed, packed or held at the facility meets the criteria for priority under section 801(h)(1) of the FD&C Act, which relates to the prioritization to detect intentional adulteration in food offered for import into the U.S.;
  5. Whether the food or the facility that manufactured, processed, packed, or held such food has received a certification as described in section 801(q) (concerning imported food) or 806 (voluntary qualified importer program) of the FD&C Act, as appropriate;
  6. Any other criteria deemed necessary and appropriate by the Secretary for purposes of allocating inspection resources.

For the FY 2011-13 planning cycle for domestic facilities, the decision-making process is based primarily on the first two factors listed, as well as certain additional criteria identified as part of the sixth factor. 

 

There are not data available at this time to characterize the third factor for all industry types. It will be incorporated as the Preventive Controls regulation and the data collection develop. 

 

The fourth factor applies only to foreign facilities. 

 

While the fifth factor may apply to some domestic facilities, the relevant certification programs have not yet been established.

 

Two additional factors that have been identified pursuant to the sixth item are: establishment type / type of activity conducted at the facility (manufacturer/processor, repacker/packer, etc.) and years since last inspection.   

Domestic risk category determination process for FY12:
  • Step 1: Determine if facility is required to register under Sec 415 Requirements. (FY12 based on data from agency's Official Establishment Inventory. Resources are allocated for facilities not required to register.) 
    If no, Section 421 (a) requirements do not apply.
    If yes, move to step 2.

  • Step 2: Determine if the facility packs, processes or holds a commodity that has been identified with known food safety risks. Known food safety risks are currently considered to be food commodities that are associated with Outbreaks and Class 1 Recalls.
    If yes, move to step 2a.
    If no, move to Step 3 Compliance History.

  • Step 2a: Determine if the facility is a manufacturer of a food commodity category associated with outbreaks AND class I recalls within previous 5 fiscal years. Or alternatively, a manufacturer or a food commodity category associated with outbreaks OR class I recalls and NOT inspected within the previous 5 years.
    If yes, the facility is considered to be a High-Risk facility and will be inspected a minimum of once within a 3-year cycle.
    If no proceed to Step 3 Compliance History.

  • Step 3: Consider the compliance history of a facility. Determine if a facility has received an inspection classification of "Official Action Indicated" (OAI) in the previous 5 fiscal years. Or alternatively, three (3) inspections classified as "Voluntary Action Indicated" (VAI) in the previous 5 fiscal years.
    If yes, the facility is considered to be a High-Risk facility and will be inspected a minimum of once within a 3-year cycle.
    If no, the facility is considered to be a Non-High Risk facility and will be inspected a minimum of once within a 7-year period.

Review a diagram of this process at this link.

WBFI Membership LogoWBFI working for you and your business 
The WBFI State and Federal Government Relation Committees and headquarters work hard to keep on top of all areas that affect our industry. Now we all have an opportunity to have immediate access to FDA FSMA updates through the website notifications we can sign up for at the link at the top of this message.
 
As additional rules are published, we will let you know and then we will review them. If there is an area of concern on which the industry should comment, WBFI will prepare a comment and submit it on behalf of the industry. 
 
You should monitor the FDA website on your own. There may be issues that are important to you. Please advise WBFIif there is an issue on which an industry comment will be helpful. 
  
Sincerely,

Sue Hays, CBC, Executive Director
Wild Bird Feeding Industry


 

WBFI Executive Committee:
President: Craig Brummell, Essex Topcrop
Vice-President: Dave Netten, All Seasons Wild Bird Store
Treasurer: Bob Yoder, Wagner's LLC 
Secretary: Sue Hays, Executive Director