Food Protection Pt. 6 Flashcards
4 key components of an enterprise food safety risk management program
1) enterprise compliance management
2) supplier and service product risk management
3) food safety process controls
4) analytics to identify the operational risks
Case of Oregon cult
1984: Oregon cult headed by Bhagwan Shree Rajneesh contaminated salad bar with Salmonella in hopes of affecting outcome of local election. 751 cases, 45 hospitalization
-only recorded case of a bioweapon being used against citizens prior to 2001
2003 Michigan supermarket case
employee contaminated 200 lbs ground beef with nicotine. 92 ill cases
1996 doughnut case
Former lab employee contaminated doughnuts with Shigella, resulting in 12 cases
4 main factors associated with higher risk foods (for intentional contamination)
1) foods prepared or held in large batches
2) short shelf life/rapid consumption
3) uniform mixing of a food (ensures all batches may contain a lethal dose)
4) ease of access to product at some point in its production or distribution
additional factors associated with higher risk foods (for intentional contamination)
-consumption by children or elderly
-large serving size
-foods with strong flavor/texture/etc. that conceal the presence of a contaminant
-absence of tamper evident packaging
-foods typically consumed by one group (ie. American brand)
-foods produced in countries with a concern for terrorism
-foods that lack quality control checks or aerosolization steps which could expose food processing employees prior to targeted group
Who regulates animal feed?
FDA
What is AAFCO
Association of American Feed Control Officials
-voluntary membership association of local, state and federal agencies
-has no regulatory authority
-works to safeguard the health of animals and people, ensure consumer protection, and provide a level playing field of orderly commerce for the animal feed industry
Federal Food, Drug and Cosmetic Act
a federal law that establishes the legal framework within which FDA operates
-has 10 chapters
-covers prohibited acts and penalties, food, drugs/devices, cosmetics, general authority, imports/exports, and tobacco products
FDA Food Safety Modernization Act (FSMA)
-shifts focus from responding to foodborne illness to preventing it
-recognizes that ensuring the safety of the food supply is a shared responsibility among different points in the global supply chain
-has 7 major “rules”
7 major rules of the FDA Food Safety Modernization Act
1) standards for the growing, harvesting, packing, and holding of produce for human consumption
2) mitigation strategies to protect food against intentional adulteration
3) current GMP and hazard analysis and risk-based preventive controls for food for humans and animals
4) sanitary transportation of human and animal food
5) accredited third-party certification bodies to conduct food safety audits and issue certifications
6) Foreign Supplier Verification Program for importers of food for humans and animals
7) Voluntary Qualified Importer Program
FDA regulated products subject to recall
human drugs
animal drugs
medical devices
radiation-emitting products
vaccines
blood/blood products
transplantable human tissue
animal feed
cosmetics
80% of foods eaten in the US
Class I recall
situation where there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death
Class II recall
situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class III recall
a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences
Market withdrawal
occurs when a product has a minor violation that would not be subject to FDA legal action.
The firm removes the product from the market or corrects the violation.
-ie product removed due to tampering without evidence of manufacturing or distribution problems
When is medical device safety alert issued?
in situations where a medical device may present an unreasonable risk of substantial harm. These situations can also be considered recalls
When is medical device safety alert issued?
in situations where a medical device may present an unreasonable risk of substantial harm. These situations can also be considered recalls
All recalls are posted weekly in the
FDA enforcement report
What factors should be considered by the recalling firm during a recall?
-results of health hazard evaluation
-ease in identifying the product
-degree to which the product’s deficiency is obvious to the consumer or user
-degree to which the product remains unused in the market-place
-continued availability of essential products
A recall strategy should address the following elements regarding the conduct of the recall (3)
-depth of the recall (how far into the distribution chain the recall will extend)
-public warning (determine if necessary)
-level of effectiveness checks to verify that all consignees have received notification about the recall and have taken appropriate action
What information does FDA request from a firm to determine if a product is violative and should be subject to a recall?
-identity of product involved
-reason for the removal or correction and the date and circumstances for the product deficiency
-total amount produced
-distribution info
-firm’s recall communication
-proposed strategy for conducting the recall
-contact info for firm official
What should recall communication convey?
-that the product in question is subject to a recall
-clearly identify the product, size, lot number, code, or serial numbers and any other pertinent descriptive info to enable ID of the product
-that further distribution or use of any remaining product should cease immediately
-where appropriate, that the direct account should in turn notify its customers who received the product about the recall
-instructions regarding what to do with the product
