FSMA - FDA Extends Deadline for Certain Provisions of Four Major Rules

As you know, the compliance dates are approaching for FSMA.  For Preventive Control for Human Foods, the compliance date for large firms in September 18th, 2016.  (This has not changed.)

But with this much of a major change in regulations, there will be areas where more guidance is needed from FDA for companies to figure out how to comply.  This is the case where these 6 issues resulted in the compliance dates being moved back, essentially 2 years from the proposed compliance date.

• certain related provisions concerning customer assurances when controls are applied downstream in the distribution chain in all four rules. 
• for facilities solely engaged in packing and/or holding activities conducted on raw agricultural commodities (RACs) that are produce and/or nut hulls and shells and for certain facilities that would qualify as secondary activities farms except for the ownership of the facility. 
• for certain facilities that color RACs.  
• for facilities solely engaged in the ginning of cotton. 
• for importation of food contact substances. 
• for certain facilities producing Grade “A” milk and milk products covered by the National Conference on Interstate Milk Shipments (NCIMS) under the Pasteurized Milk Ordinance (PMO) to comply with the CGMP requirements of part 117.

The most impactful for those processing human and animal foods is the customer assurance requirement.  This provision requires the processor to make sure the downstream customer was going to take care of a hazard in the ingredient being sold.   Basically, if Company A is selling to Company B an ingredient containing a hazard, say for example Salmonella, where Company B said they were going to heat process that ingredient.  By Rule, Company A would need assurance that Company B was going to cook it sufficiently.   This, as written, may not be easy information to get.  (Specific sections of the posting below)

The other impactful section being delayed is for facilities holding or packing raw agricultural commodities that are not classified as a farm.  These facilities are more like a farm than a processor, but because of the way the rule was written, it classifies them more as a processor.  To help determine what these facilities need to do, FDA will write a specific guidance for these facilities. (Specific sections of the posting below)

Selected sections from:
The Food and Drug Administration Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules
Final Rule; Extension And Clarification Of Compliance Dates For Certain Provisions.
 https://www.federalregister.gov/articles/2016/08/24/2016-20176/the-food-and-drug-administration-food-safety-modernization-act-extension-and-clarification-of#t-1

Hepatitis A Outbreak Link to Frozen Strawberries from Egypt

The VA Department of Health issued a health warning about a cluster of hepatitis A cases and has identified a potential association with frozen strawberries used in smoothies from Tropical Smoothie Cafe restaurants in Virginia.  The frozen strawberries came from Egypt.

This is not the first time that frozen fruit sourced from the Middle East has been a problem for Hepatitis A.   In 2013, frozen pomegranate seeds were linked to a Hepatitis A outbreak  where over 150 were infected.  Smoothies are an issue because there is no elimination step such as heating.  Any contamination on the fruit gets blended into the drink.

Virginia Department of Health News Release
http://www.vdh.virginia.gov/news/public-relations-contacts/news-releases/2016-statewide-news-releases/health-officials-warn-of-increased-hepatitis-a-risk/
Health Officials Warn of Increased Hepatitis A Risk
August 19, 2016

Frozen Corn Recalled Due to Positive Listeria Results

A Lancaster, PA frozen food distributor is recalling frozen cut corn after the North Carolina Department of Agriculture tested samples of the corn and found them positive or Listeria.  The recall affects Laura Lynn, Key Food, and Better Valu brands.

No illness have been reported to date.

FDA Recall Notice
http://www.fda.gov/Safety/Recalls/ucm517435.htm
Cambridge Farms, LLC Recalls Three Brands Of Frozen Cut Corn Because Of Possible Health Risk
For Immediate Release
August 19, 2016

Curry Spice Recalled for Elevated Levels of Lead

A Miami, FL company is recalling approximately 377,000 lbs. of spice blends containing curry powder after testing found elevated levels of lead.  The testing was completed by the NY Health Department.
Two weeks back, turmeric was recalled because of elevated lead levels, also discovered by the NY Health Department laboratory.  Companies selling spices may want review their supply chain to see where there may be spices that are subject to high lead levels.
 
FDA Recall Notice
http://www.fda.gov/Safety/Recalls/ucm517333.htm
Oriental Packing Co. Inc. Issues Alert On Lead In Curry Powder
For Immediate Release
August 18, 2016

Hepatitis Outbreak in Hawaii Linked to Raw Scallops

Raw sea scallops served at a sushi restaurant in Hawaii are being blamed for over 200 cases of Hepatitis A.  This is one of the largest Hepatitis A cases in the US in the last 20 years.

While sushi grade seafood must be frozen in order to kill parasites, this freezing process will not eliminate bacteria and viruses. 

The scallops are reported to have been sourced from the Philippines.

Hawaii Dept of Health

http://governor.hawaii.gov/newsroom/latest-news/doh-news-release-hawaii-department-of-health-orders-embargo-of-frozen-imported-scallops-and-closure-of-genki-sushi-restaurants-on-oahu-and-kauai/

DOH NEWS RELEASE: Hawaii Department of Health orders embargo of frozen imported scallops and closure of Genki Sushi restaurants on Oahu and Kauai

Texas Firm Recalls Ground Meat Due to Complaint of Metal in Product

A Texas firm is recalling 60, 350 lbs of ground meat after a complaint was made from someone who found a piece of metal.  Unfortunately, the FSIS news release does not say what conditions, in addition to one complaint, were present to necessitate such a huge recall.  Were there more complaints logged in the companies consumer complain file, was there a non-conformance on metal detectors checks or grinder plate checks, or was there a noticeable metal issue in the facility?

Good reminder to have proper checks in place for metal.


FSIS Recall Notice
http://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2016/recall-071-2016-release
Sam Kane Beef Processors, LLC Recalls Ground Beef Products Due To Possible Foreign Material Contamination
Class II Recall 071-2016
Health Risk: Low Aug 10, 2016

Alfalfa Sprouts Recalled After Linked to Salmonella Outbreak

Alfalfa sprouts from a Denver, CO facility have been liked to 30 cases of Salmonella infection spread over 9 states.  The company has issued a recall.


CDC Outbreak Notice
http://www.cdc.gov/salmonella/reading-08-16/index.html
Multistate Outbreak of Salmonella Reading and Salmonella Abony Infections Linked to Alfalfa Sprouts
August 5, 2015

Cyclosporiasis Outbreak Reported in Texas

Texas is facing another outbreak of cyclosporiasis with 66 cases now reported across the state.  In 2013, a nationwide outbreak of cyclosporiasis resulted in over 600 becoming ill.  In 2015, cyclospora contaminated cilantro resulted in over 450 becoming ill.

The parasitic agent, cyclospora, contaminates produce through the use of contaminated water.  Symptoms last about a week or so and symptoms include watery diarrhea, with frequent, sometimes explosive, stools, and in general, just feeling like heck (tired, bloated, slight fever, etc).  It can be a much bigger issue for those with compromised immune systems.


NBC 5  Dallas Fort Worth, TX
Source: Cyclospora Found in North Texas Counties Likely Food Borne | NBC 5 Dallas-Fort Worth http://www.nbcdfw.com/news/health/Cyclospora-Found-in-North-Texas-Counties-Likely-Food-Borne-389100491.html#ixzz4GT0tQSl1
Cyclospora Found in North Texas Counties Likely Food Borne By Frank Heinz

PA Distributor Recalls Frozen Green Beans Due to Listeria

A Pennsylvania distributor of frozen foods is recalling frozen green beans for Listeria.  The recall was issued after their customer, a manufacturing company, tested and found Listeria in the product. It appears that JBL is just a distributor, so there may be a bigger supply chain involved going back to the company that produced and/or packaged the product.  It appears from the expiration date that this product was packed last year, so could be linked to the CRF recall?

FDA Recall Notice
http://www.fda.gov/Safety/Recalls/ucm515115.htm
JML Ingredients Recalls IQF Cut Green Beans Because Of Possible Health Risk
For Immediate Release
July 22, 2016