Renewal Time for FDA Biennial Food Facility Registration

 It is time to renew your food facility registration for the FDA


FDA Constituent Updates
http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm416121.htm
Food Facility Biennial Registration Renewal
Constituent Update

September 26, 2014

Food facilities required to register with FDA must renew their food facility registrations this year during the period beginning on October 1, 2014 and ending on December 31, 2014. FDA encourages food facilities to renew their registrations early on in the three-month renewal period.

Updated Proposal for FSMA Animal Feed Reg Relaxes Requirements for Food Companies Supplying Waste for Feed

The FDA announced some changes in the proposed rule for  Preventive Controls of Animal Food.

One of the biggest changes was reducing the requirements on food companies that provide their waste products for animal feed.  Basically, you would not need a HACCP based system, just controls to prevent chemical and physical contamination.

Human food processors already complying with FDA human food safety requirements, such as brewers, would not need to implement additional preventive controls or Current Good Manufacturing Practice regulations when supplying a by-product (e.g., wet spent grains, fruit or vegetable peels, liquid whey) for animal food, except for proposed CGMPs to prevent physical and chemical contamination when holding and distributing the by-product (e.g., ensuring the by-product isn’t co-mingled with garbage).

They also are making the cGMP requirements more applicable to the type of feed being produced.  However, like the Human Foods updated proposal, they are looking at the possibility of adding language to affect product testing, environmental control, and supplier control.


FDA Website
http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm366510.htm
FSMA Proposed Rule for Preventive Controls for Animal Food
Establish Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
Based on FDA outreach efforts and public comments, the FDA is proposing a number of revisions to its proposed rule on preventive controls for animal food that are more flexible and less burdensome in key areas.

PCA Executives Found Guilty for Shipping Containated Peanut Butter, Now Getting Time in the Big House

The PCA executives responsible for knowingly shipping Salmonella-contaminated peanut butter were found guilty of a number of felony charges including conspiracy.  In this case, the tainted peanut butter was responsible or nine deaths and more than 700 illnesses.

The disregard for human health was pretty blatant in the charges that were brought against them.

In the end, was it worth it for them?

Wall Street Journal
http://online.wsj.com/articles/head-of-company-that-distributed-salmonella-tainted-peanuts-found-guilty-1411149368
Peanut Executive Found Guilty in Salmonella Trial
Conviction Seen as Landmark in Criminal Food-Safety Prosecutions
By
Jesse Newman 
Updated Sept. 19, 2014 6:12 p.m. ET

 A federal jury on Friday convicted the former head of a peanut-processing company of conspiracy and other charges in connection with a deadly salmonella outbreak, one of the first felony convictions of a corporate executive in a U.S. food-safety case.

Outbreak - Penn State Food Safety Propaganda

 Propaganda is a form of communication aimed towards influencing the attitude of a population toward some cause or position.   No doubt, a shameless plug - a term often used on the Internet to refer to a time when someone tries to include (or “plug”) some information that helps advance their own selfish interests.

Penn State Ag News Magazine
http://agsci.psu.edu/magazine/articles/2014/spring/outbreak
Outbreak

Fever, muscle ache, and diarrhea—perhaps even confusion, loss of balance, and convulsions. These were some of the symptoms suffered by the 33 Americans who died of listeriosis in 2011 as a result of eating cantaloupes tainted with the bacteria Listeria monocytogenes.

The outbreak — the deadliest since 1985, affecting more than 100 people in 26 states — eventually was traced to a farm in Littleton, Colorado.

Allergen Labeling Issues result in recalls for candy and soup

Mars is recalling M&M product after it was discovered the pre-labeled outside box did not have the proper allergen label...that is, the product itself had an allergen not claimed on the outer box label.

 

One could sense the issue in this case because of a timing issue.  The product had a primary package (which had the right label), and then was place in a secondary package (the box which was incorrect) and these two could have been brought together at a later time...where there may have been less scrutiny.

And in the same time interval, a soup company is recalling Lobster Bisque because carton printing errors resulted in missing the fact that the product also contained shrimp, perch, and tilapia...in addition to lobster.

 Allergen mislabeling continues to be one of the primary reasons for recalls.  Many companies have made labeling a critical check point to ensure that the label matches the product in the container.  In these cases, it is important that the system follow that product through all label additions...whether it is the original package or the addition of secondary package.


PR Newswire
http://www.prnewswire.com/news-releases/mars-chocolate-north-america-issues-allergy-alert-voluntary-recall-on-undeclared-peanut-butter-in-mms-brand-milk-chocolate-theater-box-275844291.html
Mars Chocolate North America Issues Allergy Alert Voluntary Recall On Undeclared Peanut Butter In M&M's® Brand Milk Chocolate Theater Box


HACKETTSTOWN, N.J., Sept. 19, 2014 /PRNewswire-USNewswire/ -- Today, Mars Chocolate North America announced a voluntary recall of its M&M'S® Brand Theater Box 3.40 oz UPC #40000294764 with the following lot numbers:

Changes to FSMA Rule on Preventive Controls - Product Testing, Environmental Monitoring, and Supplier Control

FDA rolled out its revised FSMA Rule for Preventive Controls for Human Foods and is allowing 75 days for comment. Part of the revisions focus on who has to comply and when (there is a broader exemption for farms is made as the defining of a small company), however probably the most important part of this is the inclusion of language on product testing environmental monitoring, and supplier control. While there is not an absolute requirement for all to have these programs in place, there is now language to say when it is required and what will be required.

 In general, if a facility says that they are controlling or verifying control of potential hazards by one of these programs, (programs traditionally termed as prerequisite programs), then that facility must have formalized programs. Below, I have clipped those sections from the proposed regulation for easier reference.

Product Testing and Environmental Monitoring - these are included in the Verification and Corrective Action sections. (117.165 and 117.150 below) Formalized programs will be needed when you are using these programs for verification of control. For example, if you have identified Listeria as a post process contaminate in an RTE food, then a program specific to that pathogen must be developed including written procedures, sampling locations within the facility, testing protocols, and identification of the laboratory conducting the testing.

Supplier Control (117.136) – The receiving company “must establish and implement a risk-based supplier program for those raw materials and ingredients for which the receiving facility has identified a significant hazard when the hazard is controlled before receipt of the raw material or ingredient.” There is a list of requirements as to what must be done including the need for on-site audits.
It would be worth reviewing the sections below.


FDA.gov

http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334115.htm

FSMA Proposed Rule for Preventive Controls for Human Food Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food

 Based on FDA’s outreach efforts and public comments, the FDA is proposing revisions to its proposed rule on preventive controls for human food that are more flexible and less burdensome in key areas.

Commenting

FDA is accepting comments for 75 days after the publication date. The FDA published the original proposed rule on January 16, 2013, and the comment period rule closed on November 22, 2013; no additional comments are being accepted on the originally proposed rule.

Study: Authenticity Trumps Food Safety? Is it a Case of Risk Analysis?

In a study to be published in the journal, Management Science, researchers concluded that people are willing to forgo the results of a poor hygiene inspection of a restaurant if they view that restaurant as authentic. 

The research originated to explain cases where Chinese restaurants, flagged for unhygienic practices such as hanging ducks at room temperature, were still held in high regard by patrons.  In fact, California law was changed to allow 'Chinese-style roast'.

Surprising?  Not really.  We see this with many traditional foods, especially where the science is broadly applied to a category of food, but there is little anecdotal evidence to support the fact that products are safe or not safe.  In this research paper, the authors describe conflicting codes...one based on law and another based upon tradition.  To me, it is a risk decision...certainly a bad inspection report gives one the idea that risk may be there, but people will also bring in their own knowledge of associated risk...has there been any outbreaks associated with 'hanging chickens'?  Haven't Chinese restaurants been hanging chickens for thousands of years?

We see this with canned foods where people will can foods using traditional methods...such as using a boiling water bath to can meat (instead of using a pressure canner).  Their mothers and grandmothers did it this way with no issue, thus there is no risk.  Perhaps those people have not been exposed to the data on the cases of botulism that regularly occur each year and thus do not know the real risk.  (The likelihood of occurrence may be low, but the severity is high).

And conversely, where there is an over emphasis on the risk of something, especially when mass media spins a given item, people are willing to view something as risky where there is no scientific support.  So in this example, these same people will get inundated with information on the supposed dangers related to pesticides in food (which represents a smaller risk, based upon USDA testing compared to risk of botulism when improperly canning meat), and go to greater lengths to avoid commercially grown produce.

With the hanging chickens, there is probably a lower risk with this specific application in that spoilage organisms outcompete pathogens on the bird, and then provided the bird is properly cooked, there is little risk.  However, law is written to take a broad range of applications into account.  It is hard to write laws specific to every application.


Management Science
http://pubsonline.informs.org/doi/pdf/10.1287/mnsc.2014.1903
Conflicting Social Codes and Organizations: Hygiene and Authenticity in Consumer Evaluations of Restaurants

David W. Lehman
University of Virginia, Charlottesville, Virginia 22904, lehman@virginia.edu
Balázs Kovács
University of Lugano, 6900 Lugano, Switzerland, kovacsb@usi.ch
Glenn R. Carroll
Stanford University, Stanford, California 94305, gcarroll@stanford.edu

Abstract

Organization theory highlights the spread of norms of rationality in contemporary life. Yet rationality does not always spread without friction; individuals often act based on other beliefs and norms. We explore this problem in the context of restaurants and diners. We argue that consumers potentially apply either of two social codes when forming value judgments about restaurants: (1) an apparently rational science-based code of hygiene involving compliance with local health regulations or (2) a context-activated code of authenticity involving conformity to cultural norms. We propose that violations of the hygiene code recede in importance when the authenticity code is activated. This claim is supported by empirical analyses of 442,086 online consumer reviews and 52,740 governmental health inspections conducted from 2004 to 2011.

Keywords: organizations; institutions; social codes; authenticity; regulatory noncompliance; consumer value ratings; restaurants; health grades

History: Received March 1, 2013; accepted December 10, 2013, by Gérard P. Cachon, organizations. Published online in Articles in Advance.