Maintenance of Records Finalized in FSMA Regulation

The Establishment and Maintenance Rule become final for those companies in the U.S. who manufacture, process, pack, transport, distribute, receive, hold, or import food for humans or animals, and foreign persons who transport food in the U.S.  Here is a simplified version of the FDA guidance to help you identify what you need to know about records needed for food operations.

Of course, this should already be in place, much having been required as part of the Bioterrorism Act of 2002.

What are the record availability requirements?

When FDA has a reasonable belief that an article of food, and any other article of food that FDA reasonably believes is likely to be adulterated and presents a threat of serious adverse health consequences or death to humans or animals, or when FDA believes that there is a reasonable probability that the use of or exposure to an article of food, will cause serious adverse health consequences or death to humans or animals, any records or other information accessible to FDA must be made readily available for inspection and photocopying or other means of reproduction. These records must be made available as soon as possible, not to exceed 24 hours from the time of receipt of the official request, from an officer or employee duly designated by the Secretary of Health and Human Services who presents appropriate credentials and a written notice. 
The records may be kept in any format, paper or electronic, provided they contain all the required information.
The records requested may be related to the manufacture, processing, packing, transporting, distribution, receipt, holding, or importation of such an article of food that are maintained by, or on behalf of, an entity subject to the recordkeeping regulation, and at any location.

Food Producers Push Back on FSMA's Feed Rule

A number of food producers, impacted by FSMA Animal Feed Regulation, have commented to FDA about the impositions that the regulation will make.

Many of the waste products generated by food processing plants, including grains generated by distillers, will be subject to the feed regulation because these products are fed to animals.  The concern is that the producers will have to absorb additional costs to implement additional food safety controls over their waste streams.  And in reality, there have been really no issues to support the need for this level of control.

 

For many, it may come to the point where it is more cost effective to dump rather then use these items for feed.  From a sustainability standpoint, this is not the way to go.  The regulation needs to written that makes it easy, yet safe, for producers to continue to use their waste streams, when appropriate, as a source of animal feed.

The Safety of Nutritional Supplements

An article in the New England Journal of Medicine warns about the dangers of nutritional supplements.  There is an increasing market of supplements, and unfortunately, the system for ensuring the safety of those supplements is inadequate.

These supplements are marketed to people looking to loose weight, to be more energetic, or to be less depressed, however, there have been instances where these supplements have been deadly or caused severe damage including liver failure.  Many of us buy into the notion that a pill can fix our issues.

We also overuse many of our normal vitamins and supplements often without the scientific evidence to support such claims.  In some cases, overuse can do more harm than good.

In a related case, there are parents who look to improve the health of their children through 'juicing'.  An article in Medical Daily shows there is a trend for children to take 'detox juice blends".  What works in adults may not be as good for children.


New England Journal of Medicine
http://www.nejm.org/doi/full/10.1056/NEJMp1315559
Perspective
Hazards of Hindsight — Monitoring the Safety of Nutritional Supplements
Pieter A. Cohen, M.D.

N Engl J Med 2014; 370:1277-1280April 3, 2014DOI: 10.1056/NEJMp1315559

Epidemiologists at the Centers for Disease Control and Prevention (CDC) recently confirmed what an astute liver-transplant surgeon in Honolulu already suspected: OxyElite Pro, a popular over-the-counter supplement, was responsible for a cluster of cases of severe hepatitis and liver failure.1 Although patients began to develop severe hepatitis in May 2013, the Food and Drug Administration (FDA), whose job it is to remove dangerous supplements from store shelves, did not learn of the cases until mid-September, 4 months later. By February 2014, the CDC had linked 97 cases, resulting in 47 hospitalizations, three liver transplantations, and one death, to OxyElite Pro. This dietary supplement was recalled, but nothing has been done to prevent another supplement from causing organ failure or death. Nor have any changes been made to improve the FDA's ability to detect dangerous supplements.

The 2007 Peanut Butter Salmonella Outbreak - Criminal Investigation Still Ongoing

The Peter Pan Peanut Butter Salmonella Outbreak is a great case study in how Salmonella can contaminate a low moisture, ready-to-eat food.  In this case, CDC reported indicated over 400 cases  linked to peanut butter that had become contaminated due to "inadvertent moisture got into the production process", or a leaky roof.

Although this case is seven years old, it is not over yet for the parent company, ConAgra.  According to a story in the Atlantic Business Chronicle, the plant underwent an investigation in 2011by the Justice Department for criminal wrongdoing.  The company and the US Attorney's office are still in negotiations regarding the investigation, where it is possible that this "will likely involve a misdemeanor criminal disposition under the Food, Drug & Cosmetics Act."

The Chronicle reports that the company has spent $25 million in connection to the investigation.  This is in addition to the 10's of millions spent on upgrading the plant and the 50 to 60 million for the recall itself.  And of course there is the loss in sales over that time period.


Atlantic Business Chronicle
http://www.bizjournals.com/atlanta/news/2014/04/01/2007-peanut-butter-recall-hanging-over-conagra.html
2007 peanut butter recall hanging over ConAgra

David Allison
Editor- Atlanta Business Chronicle
Apr 1, 2014

Seven years after a recall of peanut butter made at a Georgia plant, federal investigations are still hanging over the head of ConAgra Foods Inc.

British Study Shows Organic Unlikely to Reduce Risk for Cancer

The British Journal of Cancer published an scientific study that indicates women who eat organic foods do not reduce the risk to develop cancer when compared to women who eat a more conventional diet.


British Journal of Cancer
http://www.nature.com/bjc/journal/vaop/ncurrent/abs/bjc2014148a.html
Organic food consumption and the incidence of cancer in a large prospective study of women in the United Kingdom

K E Bradbury1, A Balkwill1, E A Spencer2, A W Roddam3, G K Reeves1, J Green1, T J Key1, V Beral1 and K Pirie1 The Million Women Study Collaborators4

1Cancer Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford OX3 7LF, UK
2Department of Primary Care and Health Sciences, University of Oxford, Oxford OX2 6GG, UK
3Worldwide Epidemiology, GSK, Uxbridge UB11 1BT, UK
Correspondence: Dr KE Bradbury, E-mail: kathryn.bradbury@ceu.ox.ac.uk
4Members of the Million Women Study Collaborators are listed before References.
Received 3 December 2013; Revised 24 February 2014; Accepted 26 February 2014
Advance online publication 27 March 2014Top of page
Abstract

Background:

Organically produced foods are less likely than conventionally produced foods to contain pesticide residues.

Methods:

We examined the hypothesis that eating organic food may reduce the risk of soft tissue sarcoma, breast cancer, non-Hodgkin lymphoma and other common cancers in a large prospective study of 623 080 middle-aged UK women. Women reported their consumption of organic food and were followed for cancer incidence over the next 9.3 years. Cox regression models were used to estimate adjusted relative risks for cancer incidence by the reported frequency of consumption of organic foods.

Results:

At baseline, 30%, 63% and 7% of women reported never, sometimes, or usually/always eating organic food, respectively. Consumption of organic food was not associated with a reduction in the incidence of all cancer (n=53 769 cases in total) (RR for usually/always vs never=1.03, 95% confidence interval (CI): 0.99–1.07), soft tissue sarcoma (RR=1.37, 95% CI: 0.82–2.27), or breast cancer (RR=1.09, 95% CI: 1.02–1.15), but was associated for non-Hodgkin lymphoma (RR=0.79, 95% CI: 0.65–0.96).

Conclusions:

In this large prospective study there was little or no decrease in the incidence of cancer associated with consumption of organic food, except possibly for non-Hodgkin lymphoma.

Keywords:

organic food; cancer; cohort; women

Changing an Establishment's Name Does Not Rid a Facility of Listeria

A Brooklyn fish processing plant was ordered to shut down due to Listeria....Listeria that never seemed to go away, even after the established changed ownership.  However, according to this report, the new and old ownership failed to take sufficient corrective actions.

We have seen in numerous cases, that once Listeria gains a foothold in a facility, the best you can do is control it...and that takes a lot of work.  According to a prominent lawyer website report, FDA had found Listeria in the facility 48 times over a 6 year period...presumably the same strain.

Even used equipment can harbor Listeria for years.  To rid used equipment of Listeria,  intense detail cleaning is needed.  For a plant, detailed cleaning to the point of pathogen free can be a bit more difficult (drains, cracks in floors, etc).

Listeria is not the only pathogen that can be a problematic environmental pathogen.   In 2008, Mars Pet Food closed a facility after a restart failed after two recalls due to Salmonella.  It will be interesting to see if after the Sunland Food plant purchase, whether that facility will have ongoing issues.


Daily News

http://www.nydailynews.com/new-york/judge-shuts-brooklyn-fish-processing-plant-article-1.1740508
Judge shuts down Brooklyn fish processing plant
A federal judge has ordered the shutdown of Brooklyn fish processing plant New York City Fish, which has been plagued for years by life-threatening Listeria bacteria.
BY John Marzulli 

NEW YORK DAILY NEWS

Monday, March 31, 2014, 1:10 PM

A federal judge has ordered the shutdown of a Brooklyn fish processing plant that has been plagued for years by life-threatening Listeria bacteria.

Judge Roslynn Mauskopf stuck a harpoon in New York City fish, granting the government's request for a permanent injunction against the plant located on Chester St. in Brownsville, which distributes smoked salmon, mackerel and herring.

Country of Origin Labeling Requirement for Meat Moves Forward

 The US Court of Appeals is allowing the country of origin labeling requirement (COOL) to move forward despite the challenge by meat producers.

The law will require processors and retailers to list where the animals used in the product were born, raised and slaughtered.

While this will provide information to consumers, there is no doubt it will add costs to the system.  Just are important is that many countries such as Canada and Mexico will look at this as a trade barrier and may inflict retaliatory tactics to US trade.

Are the costs worth it?  Do consumers really care?


Reuters
http://in.reuters.com/article/2014/03/28/usa-courts-regulations-food-idINL1N0MP1C920140328
U.S. meat groups thwarted in bid to block country-of-origin labels

(Reuters) - A U.S. appeals court on Friday rejected a challenge by meat producers to a federal regulation that specifies labeling requirements for certain meat products, a move applauded by rancher and consumer groups.

Fresh Express Recalls Packages of Salad Due to Listeria

 Fresh Express is recalling 10oz  and 6 oz packages of Italian Salad due to the potential to be contaminated with Listeria.  The product in question is already past its stated expiration date. 

There was no information on how the issue was discovered. 

FDA Recall Notice
http://www.fda.gov/Safety/Recalls/ucm391048.htm
Fresh Express Issues Recall of Limited Quantity of Already Expired Italian Salad Due to Possible Health Risk, No Illnesses Cited

FOR IMMEDIATE RELEASE - March 28, 2014 - Salinas, California – Fresh Express Incorporated has issued a recall of a limited number of cases of 10 oz. and 6oz. Italian Salad with the already expired Use-by Date of March 26 and a Product Code of H071A11A due to a possible health risk from Listeria monocytogenes. No illnesses have been reported in association with the recall and no other Fresh Express products are being recalled.

Reaching Consumers with Product Safety Information - A Challenge for FSMA Regulation

On March 26th, FDA issued advanced notice of their proposed Implementation of the Food and Drug Administration Food Safety Modernization Act Amendments to the Reportable Food Registry Provisions of the Federal Food, Drug, and Cosmetic Act(link). In summary, FDA is looking for a way to communicate food safety product notices (recalls) to consumers. The objectives are for companies to provide standardized information to FDA, FDA to develop a one-page recall notice regarding that food safety issue with a reportable food, and then that notice will then be distributed by the retail outlets, or grocery chains, to the consumers.

 

Sounds easy enough, however, there are many challenges in establishing a protocol that will work. Chiefly among them is the fact that consumers are not an easy group to reach with recall this type of information. So how do retailers do this to a point where it is not costly? And from a practical standpoint, will this mandated system have an impact compared to what currently happens today?

 

This has implications for the manufacturers, but more so for the grocery chains.

 

Here is a ‘quick’ summary, much taken directly from the seven page document published in the Federal Register.