Monday, August 26, 2013

How Safe is Our Food? FDA Recalls for Undeclared Food Allergens Increasing Trend

"Allergens were the single largest cause of food recalls, composing approximately 60 percent of recalls initiated in the second quarter [2013], up from 34 percent in the first quarter.  Allergens have been the first or second largest cause of [FDA] food recalls in the past six quarters."  Stericycle Expert RECALL- Recall Index- 2nd Quarter 2013.
The Food and Drug Administration ("FDA") is the government agency of the Department of Health and Human Services which regulates food, except for certain farmed and raw products, including but not limited to meat, poultry, eggs, and milk, which is regulated by the Food Safety and Inspection Service ("FSIS"), an agency of the U.S. Department of Agriculture ("USDA").  Both have processes for recalling foods for undeclared allergens. 
There are three basic ways a product can be recalled for containing an undeclared food allergen:
1) Someone has an allergic reaction to the product and reports the suspected undeclared allergen.  This would require follow up by either the company or the FDA or FSIS to test the product.  If you get sick from a suspected undeclared allergen, always save the product in the freezer, so it can be tested.
2)  The company self-tests and realizes there has been a breach of its safety protocol and volunteers to recall the product.
3) The FDA or FSIS send in inspectors who test the products and find an undeclared allergen.
Let's talk "May Contain" or "Manufactured on Shared Equipment" or "Manufactured in a Facility" statements (or "Squishy Statements").  FALCPA does not require these specific statements.  What FALCPA requires is black and white:  If the food contains one of the top 8 allergens, then that allergen must be disclosed as an ingredient on the label.   
This has created a gray area in labeling, because an allergen may not be an intended ingredient, but it may find its way into the product by cross contamination.  If the food does contain an allergen through cross contamination, it is not declared on the label, and someone has an allergic reaction, the label is not FALCPA compliant and the company has liability. 
So why Squishy Statements instead of just testing the food?  The ELISA tests used by manufacturers to test food for allergens can only be calibrated to a certain parts per million ("ppm"), so they cannot really know the level of cross contamination.  This is a problem when the tests for a food allergen are not as sensitive as a food allergic person.  For example, a peanut ELISA may only detect peanuts to 2.5 ppm, but a severely allergic person may react to 0.4 ppm.  Food Safety Magazine Article  So, the ELISA test may come back negative, but the peanut allergic consumer may have an allergic reaction from the product which contains a minute amount of allergen because of shared equipment or facility.  This is how the birth of the Squishy Statements came about. 
Since there is no requirement for a manufacturer to put a Squishy Statement on their product, even if it is made in a facility or on equipment with an allergen, some simply don't.  Then there are some manufacturers who, with or without a Squishy Statement, don't test for the allergens if they are not on the ingredient list.  Note, that in either case, if the product is actually contaminated with the allergen, the manufacture is not in compliance with FALCPA in these circumstances.  It is the job of the FDA and FSIS to protect against these bad practices or even accidental contaminations. 
So, how are the FDA and FSIS different in their processes?  The FDA seemed to really be the first agency to start rapidly recalling products after the Food Allergy Labeling and Consumer Protection Act of 2004 ("FALCPA") was enacted.  However, many of those recalls were voluntary recalls by manufacturers trying work out the kinks in complying with the Act.  In general, the FDA is more reactive and the FSIS is more proactive when it comes to product labeling.  The FSIS is more focused on the labeling up front, before there is a problem.  However, until recently, while the FSIS was focused on labeling generally, it was not focused on food allergens.  That tide seems to be changing.
A recent notice issued by the FSIS directs its food inspectors to spend time specifically examining the way a food manufacturing plant treats food allergens.  This includes determining which of the top 8 (eggs, milk, peanut, tree nuts, fish, shellfish, wheat, soy) are contained in the facility, how such allergens are kept separate from other foods, examining all sauces and additives to meats and other foods, and looking at the labels of the products to make sure they adequately disclose all allergens.  Note, this is a proactive inspection- before FSIS is notified of any problem.  This notice, which was issued in April 2013, is available online.  FSIS NOTICE 
The recent FSIS notice is likely a result of the increase in recalls for undeclared allergens, which exceed FSIS recalls for pathogens by far. Stericycle USDA Report - 2nd Quarter 2013  Similarly, undeclared allergens were 60% of the recalls by the FDA for the same quarter.   Stericycle Expert RECALL- Recall Index- 2nd Quarter 2013. 
So, how do we keep our kids safe in light of the fact that millions of units of products with undeclared allergens are entering our grocery stores?  First, watch the recalls yourself.  You can do this by checking here FDA Recalls every few days or once a week to make sure that nothing in your house or on your grocery list was recalled or sign up here FDA Email for email alerts of recalls from the FDA, as they occur.  Second, do not take the chance on products with Squishy Statements.  Those statements are put there to alert you to a risk.  Do not ignore them.  The companies may be trying to comply with FALCPA, but cannot really know whether their product contains the allergen because the testing is not there yet. 
While Squishy Statements and recalls are how we are protected, no bite is ever risk free. 

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