FDA Releases FSMA Rules on Produce, Foreign Suppliers, and Third Party Auditors

FDA released three new rules as past of the Food Safety Modernization Act. 

• The Produce Safety Final Rule focuses on requirements for farm activities associated with growing and harvesting produce.
• The Foreign Supplier Verification Program (FSVP) rules sets requirements for those importing food into the US to ensure that those suppliers are following the same requirements as US food manufacturers.
• Associated with FSVP, there is the Accredited Third Party Audit Certification Rule which sets up a program for certifying third party auditors who will evaluate foreign suppliers.

FDA Website

http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm472505.htm

FDA Releases Groundbreaking Rules on Produce and Imported Foods to Modernize and Strengthen Food Safety System

Constituent Update

November 13, 2015

 

The U.S. Food and Drug Administration today took major steps to prevent foodborne illness by finalizing rules that establish enforceable safety standards for produce farms, and make importers accountable for verifying that imported food meets U.S. safety standards. The agency also issued a rule establishing a program for the accreditation of third-party certification bodies, also known as auditors, to conduct food safety audits of foreign food facilities.

 

FSIS Updates Allergen Guidance with Focus on Incoming Ingredients

FSIS issued an updated version of their Allergen Control Guidance.  Allergen issues remain on the leading causes for recalls.  According to FSIS:

What is causing undeclared allergen recalls?

• New Ingredient
• New Supplier
• Misprinted Label
• Product in Wrong Package
• Product Reformulation
• Ingredient Reformulation

 A focus of this update involves ingredient related allergen issues. Inspectors are discovering issues as they evaluate incoming ingredients and a company's formulation. 

"FSIS has found that many of these recalls occurred because of a change in product formulation by the establishment or a change in a supplier’s ingredient formulation that was not reflected on the labeling of the finished meat or poultry product. "

A noted change was an explanation of a Letter of Guarantee (LOG) and a Certificate of Analysis (COA). Too many rely on a LOG to protect them against a supplier related allergen issue, but a LOG cannot be counted on to prevent allergen issues.

"An establishment should review and update the LOGs regularly to ensure that the decisions made in the hazard analysis are supported and to ensure that any formulation changes made by its suppliers are detected prior to incorporating the associated ingredient into the production process. Generally, an annual LOG will not be sufficient to support decisions made in the hazard analysis."

One of the nice additions is Appendix 6 - Allergenic Ingredients in Foods.  In this appendix, there is a list of common ingredients that contain specific allergens that may be missed.  This is a nice reference.  (For example, marzipan may contain eggs).

 

FSIS Website

FSIS Compliance Guidelines 

http://www.fsis.usda.gov/wps/wcm/connect/f9cbb0e9-6b4d-4132-ae27-53e0b52e840e/Allergens-Ingredients.pdf?MOD=AJPERES

Allergens and Ingredients of Public Health Concern: Identification, Prevention and Control, and Declaration through Labeling 

November 2015

[from the document - page

Purpose 

 

This document provides guidance to assist establishments in addressing the hazard posed by allergens in their products. In doing so, establishments must comply with the Food Safety and Inspection Service (FSIS) hazard analysis and critical control point (HACCP) and labeling regulations. 

Cans of SpaghettiOs Recalled Due to Potential Choking Hazard

Campbell soup is recalling one code date of SpaghettiOs (14.2 ounce cans of SpaghettiOs Original) due to a potential choking hazard posed by pieces of red plastic found in a small number of cans. This plastic material is from parts of the can lining which may peel off.

 FDA News Release
http://www.fda.gov/Safety/Recalls/ucm472508.htm
SpaghettiOs Original 14.2oz Cans Recalled Due to Potential Choking Hazard
For Immediate Release
November 12, 2015

Unpasteurized Apple Juice Leads to Two Outbreaks

Fresh apple cider in autumn...nothing better.

But unfortunately, contamination on apples can make its way into the cider unless preventive controls are taken.  So far this season, there have been two examples of contamination in fresh cider.

A small California farm stand, High Hill Ranch, was linked to seven cases of E. coli illness among  residents who consumed the unpasteurized apple juice from High Hill Ranch in mid-October.
In an statement issued by the owners of the farm, it appears that they are missing the point (below).
E. coli is more likely to be picked up from ground apples (wind fallen apples, drops, or whatever you want to call them).

A second case in Illinois may be a case of cryptosporidium, a parasite often originating from a contaminated water source, such as contaminated wash water or irrigation water.  Again, apples off the ground can be an issue.

Many folks like to have that fresh juice, however having it processed can eliminate any potential risk.  This is the reason the Juice HACCP regulation of 2001 was implemented.  There are other means of having it process that do not impact the flavor as much as heat pasteurization.  One is UV treatment and the other is high pressure processing.  These two methods impact flavor less but can help retain that fresh

County of El Dorado
https://www.edcgov.us/pressreleasedetail.aspx?id=30064771392
High Hill Ranch Issues Voluntary Recall of Unpasteurized Apple Juice

Department: Public Health Contact: Creighton Avila  Phone#: (530) 621-5153
Date: October 23, 2015

High Hill Ranch, located in the community of Camino in El Dorado County, has initiated a voluntary recall of its unpasteurized apple juice following notification from local health officials of suspected contamination with bacteria, likely Escherichia coli (E. coli.). El Dorado County health officials are warning consumers to not drink and dispose of any unpasteurized apple juice purchased from High Hill Ranch on or after October 6, 2015.

China's 2015 Food Law - Understanding Import Challenges

There is a nice piece in National Law Review on China's recently enacted 2015 Food Law and some of the challenges they face.  While the law was made to look like US law, there are many differences in components that are not easily regulated - "....it lacked the right enforcement devices.  Part of the food safety regime in Western countries relies on active consumer groups, industry self-enforcement, and media scrutiny.  China does not have these mechanisms."

While the 2015 law tries to encourage better 'local regulatory enforcement, food industry associations, and media oversight' there is little detail on how this can be done.  Add to this the fact the food industry is very fragmented with many smaller processors, it can be difficult to provide oversight.

Still, China is currently the third largest importer of food into the US.  With the soon to be released FDA's Foreign Supplier Verification Rule, additional attention will be required by companies and brokers importing food.

National Law Review
http://www.natlawreview.com/article/food-supply-chain-issues-china-or-china-s-new-food-safety-act-or-running-gauntlet
Food Supply Chain Issues in China (Or, China’s New Food Safety Act) (Or, Running the Gauntlet in China)
posted on: Monday, November 2, 2015

Food trade between the U.S. and China is on the rise. According to the most recent statistics, China is the third largest exporter of food and agricultural products to the U.S., behind only Canada and Mexico. And, the U.S. is China’s biggest source of foreign food and agricultural products. Under the current state of trade, the U.S. sends approximately five times the food products to China that China sends to the U.S. But in any event, with the coming into force of China’s newest Food Safety Law on October 1, 2015, food supply chain relationships between the U.S. and China are taking on additional significance.

 See more at: http://www.natlawreview.com/article/food-supply-chain-issues-china-or-china-s-new-food-safety-act-or-running-gauntlet#sthash.JcXfS3vT.dpuf

CDC - Multistate Foodborne Outbreaks — United States, 2010–2014

In MMWR, the CDC published an analysis of data in the Foodborne Disease Outbreak Surveillance System from 2010 - 2014. The document can be found here.

What were the important results:

• During this 5-year period, 120 multistate foodborne disease outbreaks (with identified pathogen and food or common setting) were reported to CDC.
• These multistate outbreaks accounted for 3% (120 of 4,163) of all reported foodborne outbreaks, but were responsible for 11% (7,929 of 71,747) of illnesses, 34% (1,460 of 4,247) of hospitalizations, and 56% (66 of 118) of deaths associated with foodborne outbreaks. [Listeria accounted for the largest percentage of deaths - 86%]
• Salmonella (63 outbreaks), Shiga toxin-producing E. coli (34), and Listeria monocytogenes (12) were the leading pathogens.
• Fruits (17), vegetable row crops (15), beef (13), sprouts (10), and seeded vegetables (nine) were the most commonly implicated foods.
• Imported foods were linked to 18 multistate outbreaks.

It is interesting to read the headlines that follow this release.
Big and deadly: Major foodborne outbreaks spike sharply (Washington Post) goes on to say that major foodborne outbreaks in the United States have more than tripled in the last 20 years.
Well, our improvement in being able to see outbreaks has improved in the last twenty years.  With Pulsenet, CDC can work with states to find outbreaks.  This system came online 20 years ago and has continued to improve, especially with the development of whole genome sequencing.  So of course we see more outbreaks than we saw 20 years ago, but that does not mean they didn't exist.  And if you had to guess, you would say that there were more 20 years ago then there are today.

Nebraska Establishment Recalls 167,000 lbs of Ground Beef After E. coli Positive Test Result

A Nebraska meat establishment is recalling approximately 167,000 lbs of ground meat after USDA found a positive sample in their 'in-commerce' testing.  There have been no reported illnesses.

USDA News Release
http://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2015/recall-135-2015-release
All American Meats, Inc. Recalls Ground Beef Products Due to Possible E. Coli O157:H7 Contamination
Class I Recall 135-2015
Health Risk: High Nov 1, 2015

Congressional and Public Affairs   Kristen Felicione  (202) 720-9113 

WASHINGTON, Nov. 01, 2015 – All American Meats, Inc., an Omaha, Neb. establishment, is recalling approximately 167,427 pounds of ground beef products that may be adulterated with E. coli O157:H7, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

Chipotle Shuts West Coast Locations After Linked to E. coli Outbreak

UPATE - 12-21-15 - CDC reports that a total of 53 people have become infected in 9 different states.  From the CDC report - "The number of ill people reported from each state is as follows: California (3), Illinois (1), Maryland (1), Minnesota (2), New York (1), Ohio (3), Oregon (13), Pennsylvania (2), and Washington (27)."

Update - 11/4/15 - Reports have the total number of cases at 35 (as of Tuesday, 11/3) for those infected by E. coli O26.   


11/2/15
Chipolte restaurants closed 43 west coast restaurants because of a potential link to E. coli outbreak.  As of the Oct 31st, there were 22 reported illnesses.  The ingredient source of E. coli has not yet been identified.

This is the third major outbreak associated with the chain. In September, a California location was involved in a Norovirus outbreak where 80 individuals become ill.  In the same month, 22 locations were linked to 64 cases of Salmonella infection.  In this case, tomatoes were pinned as the source.

This has had a impact on the business as the stock price has dropped to a 4 month low.


Reuters Business News
http://www.reuters.com/article/2015/11/02/us-chipotle-ecoli-idUSKCN0SQ2CE20151102
Chipotle shuts Seattle, Portland stores after E. coli outbreak
Sun Nov 1, 2015 10:59pm EST
Related: Health, Mexico
NEW YORK/LOS ANGELES | By Ransdell Pierson and Lisa Baertlein
Chipotle Mexican Grill Inc said on Sunday it had closed all its restaurants in two West Coast markets due to a reported outbreak of E. coli bacteria that is being investigated by the company and health authorities.

Juice Processor Ordered to Cease Operations for Lack of Compliance

An Idaho juice processor was ordered to cease production after not complying  with FDA regulations.  The juice processor was not heat pasteurizing, and according to juice regulations, there must be validated reduction steps in place.  Normally, juice processors use heat pasteurization to accomplish this.  It is unclear what, if anything, this processor was doing.

FDA News Release
http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm470328.htm
FDA orders juice manufacturer to cease operations
For Immediate Release
October 30, 2015
Release