(seafood.com) FDA posts Warning Letters each week, which stay on its website for a few days and then “disappear” into an archive and become difficult to find. Those concerning seafood are reported in our Trade Alerts when they are posted.
Warning letters target violations of “regulatory significance” and include a threat of legal action if you don't comply. While all are serious (some provide damaging evidence to competitors and for criminal prosecutions and class-action lawsuits), others have more immediate consequences. Foreign facilities, for example, face the prospect of refusals under an Import Alert.
Because these letters are a surrogate measure of FDA's enforcement activities, any significant change in their number should raise questions about what's going on - and a significant change has occurred.
What Happened?
Starting in late 2009, the number of seafood letters began to increase significantly, rising 42 percent between 2009 and 2010, and then another 43 percent between 2010 and 2011. Here's the trend:
Increases were particularly significant for domestic seafood processors, which received most of the letters during this period.
Type of Seafood Firm Receiving a Warning Letter 2009 – 2011
No seafood firm engaged solely in warehousing, transportation or retail was warned. But a broad range of processors and importers --- both small and large --- were, including a few to sophisticated processors of breaded, smoked and canned seafood. In recent months, however, more letters appear to be going to smaller firms --- making products like tuna sandwiches and salads. Typically, FDA cited a firm for a seafood HACCP violation and then added on other violations.
The three most frequently cited deficiencies were ---
• Inadequate temperature controls - especially for histamine-forming species, pasteurized crabmeat, chilled vacuum-packed fish and ready-to-eat products;
• Lack of HACCP planning - especially for tuna sandwiches and sushi;
• Importers - lacking product specifications and verification steps.
There also appears to be more testing for Listeria during FDA inspections, which prompted more FDA comment about controlling it.
Most letters only reference the Seafood HACCP Guide and a FDA rule --- so they don't break new legal ground. However, every now and then a letter reveals a new or little known FDA enforcement policy. High-profile examples were two warning letters in 2009-2010, which cited the inclusion of ice glaze or frozen marinade in the net-weight label for shrimp. They were prompted in part by tests conducted by state weights and measures inspectors in 17 states that found glazing on frozen seafood wrongly included as part of the labeled net weight.
Nothing like that occurred in 2011 that but there were a few letters that caught my eye.
• A letter to an importer acknowledging that it could fulfill its HACCP verification requirement by sourcing from firms on the "List of Canadian Establishments Approved for Export" on the FDA website, but then warning that the importer “should maintain copies of that list demonstrating that, at the time of importation, the firm was listed as approved” --- something it had not been doing. (There's no FDA guidance referring to this policy.)
• Another importer gave FDA a copy of his foreign supplier's HACCP plan as its affirmative step, which FDA then reviewed and said was inadequate. (Having a copy of your supplier's HACCP plan is a common “affirmative step” --- but, as this letter illustrates, it exposes your supplier to violations that can be avoided if you chose another alternative.)
• A letter saying the Chesapeake Bay posed a reasonable risk of environmental contamination, requiring a primary processor to have HACCP controls when buying Croaker and Spot.
• A letter to a crab processor acknowledging that while it was “obtaining a certificate accompanying the live crab that indicates the area the crab was obtained from”, it was “not correlating the area information to information that identifies areas closed to harvesting or under consumption advisories.”
• A letter to a processor who was labeling and advertising fish as being low fat and useful in reducing body weight, leading to allegations of more than 20 misbranding violations. (Be careful about nutritional claims and what you say on your website.)
Looking Ahead
Changes in FDA enforcement policies (including an expansion of the authority of FDA Districts to issue letters) and increases in the number FDA inspectors and inspections are part of the reason why more Warning Letters were issued.
FDA reports that its inspections of “high-risk” food facilities rose 13 percent between FY 2009 and FY 2010. The FDA target for last year was 7,800 “high risk” facilities and the number of FDA inspections of foreign food facilities jumped from 171 to 438 between FY 2010 and FY 2011. (Statistics on seafood inspections are not available.)
The target for “high risk” facilities increased again this year to 8,850 and additional Congressional directives about inspections in the Food Safety Modernization Act (FSMA) are likely to further increase the number of letters in the future.
In the past, FDA was hesitant give foreign firms a Form FDA-483 (Inspectional Observations form) at the close-out of an inspection, and to send them Warning Letters. This clearly is changing --- although there has been no significant surge so far in the letters issued to foreign seafood processors.
The FSMA, however, directs the agency to inspect at least 1,200 foreign food facilities by this October --- an increase of more than 100% percent over last year --- which FDA told Congress “may be attainable”. FDA also plans to increase its assessments of the foreign regulatory programs from five to nine this year.
If these additional inspections do occur, there may be a corresponding increase in warning letters --- and import detentions.
Additional Help
While you can search the word “seafood” on the FDA website and find the warning letters alleging a seafood HACCP violation, you'll miss many other letters concerning seafood --- and there's no single word, or easy way to find them other than by reading the letters as they are posted each week on the FDA website.
So --- to help you find what FDA has said about seafood in the past, I'm posting my 2009-2011 tables for FTD subscribers. You also can search for company names or specific products or violations using the “search” feature on our website.
Your email comments to me on this issue are welcome.
Richard E. Gutting, Jr. regutting@rpb-law.com