FDA Draft Guidance - Hazard Analysis Risk Based Preventive Controls for Human Foods

On 9/23/16, FDA issued the Draft Guidance for Hazard Analysis and Risk Based Preventive Controls for Human Foods.   The guidance was put together to help people who are developing their FDA mandated Food Safety Plan. It can be found here.

Upon review, this document will serve as a resource for those writing their plans.  For those who took the FSPCA training, you will find that this document pretty much mirrors the FSPCA Participant Manual.  In fact, many of the tables are the same ones found in the FSPCA Participant Manual. 

This is a draft guidance, so FDA will be taking comments and making modifications.  Hard to imagine there will be any major revisions.


FDA Website
http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm517412.htm
Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food

Cashew Product Recalled Due to Possible Allergen Contamination with Peanuts

 An Ohio Company is recalling 10 ounce stand-up pouches (SUPs) of cashews after it was determined that there could be peanuts present.

While peanuts and cashews are both allergens, they are not the same allergens.  Thus this is an allergen issue and requires corrective action.  There can be some cross-reactivity - people who are allergic to one can  be allergic to the other.  

Cross contact of peanuts and tree nuts can be an issue in facilities that handle both types of nuts.

FDA Recall Notice
http://www.fda.gov/Safety/Recalls/ucm519248.htm
Kanan Enterprises Conducts Voluntary Recall of Cashews with Sea Salt
For Immediate Release
September 3, 2016

Ravioli and Brownies Recalled After Complaints of Plastic Pieces

Two different recalls were initiated after consumer complaints were registered about plastic pieces found in the product.  One was for ravioli containing white plastic and the other was for small pieces of plastic in Entenmann’s muffins and brownies.

The recalls are unrelated.  No injuries have been reported.

FDA Recall Notice
http://www.fda.gov/Safety/Recalls/ucm519172.htm
Wegmans Announces Voluntary Recall for One Date Code of Wegmans Italian Classics Striped Ricotta & Spinach Ravioli, Which May Contain Pieces of White Plastic
For Immediate Release
September 2, 2016

Chocolate Products Recalled After a Positive Salmonella Result Found

A Pennsylvania firm is recalling chocolate products after one internal test result was positive for Salmonella.  There have been no illnesses reported.


FDA Recall Notice
http://www.fda.gov/Safety/Recalls/ucm519188.htm
Asher's Chocolates/Lewistown, Inc. Issues Voluntary Recall of Candy Products Because of Possible Health Risk
For Immediate Release
September 2, 2016

Improving Knowledge of Antibiotic Resistance - What You Should Know

This month's Food Protection Trends has an article by a group of experts on the topic of antibiotic resistance and the impact on human and animal health.  The goal was to provide knowledge to professionals in an way to counter the many misstatements being made in the news media by uninformed 'professionals.'

First, there are four main themes that should highlight communications:

Packages of Cut Fresh Vegetables Recalled Due to Listeria Positive Sample

A Texas firm is recalling various fresh diced and sliced vegetables after the Georgia Department of Agriculture sampled product and found it was positive for Listeria monocytogenes.  The date range for production lots recalled is about two weeks with use by dates from 8/7 to 8/19/16. At this point, no illnesses have been reported.

The reason for the broad range of items is that there must be concern for cross contamination in the facility.  Being that there are sliced and diced vegetables, the equipment used for processing, the cutting equipment, the flume lines for transferring, and the packaging equipment can be areas for cross contamination or even be a harborage site for the organism if it was not properly cleaned.


FDA Recall Notice

http://www.fda.gov/Safety/Recalls/ucm518335.htm
Country Fresh Recalls Product Because Of Possible Health Risk
For Immediate Release
August 26, 2016

FSMA Compliance Date Schedule - September 18th for General Compliance

FDA's FSMA compliance dates are nearing.  Take a few minutes to review to see if you are where you need to be.

Source - GMA website
http://www.gmaonline.org/file-manager/GMA%20Summary%20Reference%20Sheet%20for%20FSMA%20Compliance%20Dates.pdf

*Farms have an additional 2 years to comply with certain water-related requirements. Separate compliance date applicable to sprouts.

**PC Human: Supply Chain Program general compliance is (1) 3-17-17 (9-18-17 for small business) OR (2) six months after a supplier is required to comply with the applicable rule. PC Animal: Supply Chain Program general compliance is (1) 9-18-17 (9-17-18 for small business) OR (2) six months after a supplier is required to comply with the applicable rule.

†All importers must comply with FSVP requirements by 5-30-17 OR 6 months after their foreign suppliers’ reach their FSMA compliance deadlines, whichever is later. “Very small importers” and “importers of food from very small foreign suppliers” are subject to modified requirements.

‡ 3PAC’s provisions are effective immediately following the final rule, but can only be implemented after publication of Model Accreditation Standards, which are yet to be released by the FDA.

EpiPen Price Hike Impacts People with Food Allergies

EpiPens, those self-given injection needles to prevent allergic reactions, have gone up in price to over $600 for a set of pens..  Even with insurance, the price can be as much as $200 to $300 per set.   And considering these pens have a limited shelf-life of a year, this is a reoccurring cost.

EpiPens deliver epinephrine, a drug that slows the symptons of the immune response such as swelling.  In those people that are highly allergic to an allergenc such as peanuts or crustacean shellfish,  swelling of body tissue including the throat can be life threatening.  So these folks need to carry EpiPens.

NY Times
http://well.blogs.nytimes.com/2016/08/22/epipen-price-rise-sparks-concern-for-allergy-sufferers/?_r=0
EpiPen Price Rise Sparks Concern for Allergy Sufferers
By Tara Parker-Pope and Rachel Rabkin Peachman August 22, 2016 6:05 pm August 22, 2016 6:05

A steep increase in the price of the EpiPen, a lifesaving injection device for people with severe allergies, has sparked outrage among consumers and lawmakers who worry that parents won’t be able to afford the pens for children heading back to school.

Frozen Chicken Entrees Recalled Due to Foreign Material

Another recall due to consumer complaints on foreign objects in product.   In this case, a GA company is recalling chicken entrees with glass or hard plastic.

FSIS Recall Notice
http://www.fsis.usda.gov/wps/wcm/connect/FSIS-Content/internet/main/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2016/recall-074-2016-release
Sentry Foods Recalls Frozen Chicken Entrées due To Possible Foreign Matter Contamination
Class II Recall 074-2016