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
What information should be included in a recall status report (periodic update reports submitted by recalling firm)
1) # of consignees notified of the recall/date/method of notification
2) # of consignees responding to the recall communication and quantity of products on hand at the time it was received
3) # of consignees that did not respond
4) # of products returned or corrected by each consignee contacted and the quantity of products accounted for
5) # and results of effectiveness checks that were made
6) estimated time frames for completion of the recall
When is a recall terminated?
when the FDA determines that all reasonable efforts have been made to remove or correct the product IAW recall strategy
When is a recall terminated?
when the FDA determines that all reasonable efforts have been made to remove or correct the product IAW recall strategy
Recent large recalls
-grain free dog foods linked to DCM
-Aunt Jeni’s Home made frozen raw pet food (Salmonella)
-Sunshine Mills pet foods (mycotoxicosis)
What is aflatoxin
naturally occurring mold by-product from growth of Aspergillus flavus
2018 Vitamin D toxicosis dog food recall
-at least 8 brands of dry dog food potentially affected
-excess vitamin D can cause vomiting, dec. appetite, increased thirst, increased urination, excessive drooling, weight loss, kidney failure, death
Melamine recall (2007)
-rice protein laced with melamine, a component of fertilizers and plastic utensils was being added to some wheat gluten pet foods coming from China
-16 animal deaths reported (actual death toll could be in the thousands)
-can cause kidney failure
Pig ear dog treats and salmonellosis (2019)
-154 cases of human infection tied to exposure to pig ear pet treats with Salmonella
-pig ear treats traced back to sources in Argentina, Brazil, and Colombia
-outbreak is currently over
Ideal temp for best shelf life of canned or dried foods
40-70F in a cool dry dark place (<15% humidity)
formula for disinfecting water with bleach
1/8 teaspoon of bleach per gallon of water
Freezer temp should be kept below __F
0F
How to prepare for a power outage
-have appliance thermometers in your fridge and freezer
-have ice/ice packs available
-freeze items that can be eaten when they thaw out (leftovers, milk, etc.)
-keep food grouped together in the freezer
-have coolers on hand
What to do if you lose power
-keep fridge/freezer doors closed as much as possible
-purchase dry or block ice
-thoroughly cook meat/eggs to safe minimum internal temps
minimum internal temperature for beef, pork, veal, lamb, ham, fish, shellfish
145F
minimum internal temperature for ground meats, eggs
160F
minimum internal temperature for poultry, leftovers, casseroles
165F
when should meat, poultry, fish be discared?
if above 40F for >2 hours or >90F for 1 hour
how long should water be boiled to make it safe
at least 1 minute
What to do with food after a disaster/power outage
-throw away perishable food that hasn’t been refrigerated or frozen properly due to power outages, came in contact with storm water, or any food with unusual odor/color/texture, or any food near a fire
-any food that has been at temps above 40F for 2 hours or more
-all perishable foods in the refrigerator if the power has been off for 4+ hours
-all perishable foods in the freezer that have thawed
How to salvage commercially prepared food in cans and plastic or metal pouches
-remove labels/dirt
-wash in hot soapy water
-rinse in clean water
-sanitize in bleach water or by boiling cans for 2 minutes
-re-label cans or pouches
-use as soon as possible
Which foods are SAFE to eat if held above 40F for >2 hours?
-Hard cheeses
-processed cheeses
-grated parmesan, romano cheese
-butter, margarine
-opened fruit juices
-opened canned fruits
-fresh whole fruits, coconut, raisins, dried fruits, candied fruits, dates
-PB, jelly, relish, taco sauce, mustard, ketchup, olives, pickles
-soy sauce
-bread, rolls, cakes, muffins, quick breads, tortillas
-waffles, pancakes, bagels
-fruit pies
-mushrooms, herbs, spices
-raw whole veggies
boil all home-canned, low-acid vegetables and meats __ minutes plus one minute per 1,000 feet in altitude before tasting
10 minutes
Which food items can be refrozen if thawed and held above 40F for >2 hours?
-hard cheeses
-juices (unless smell/mold develops)
-home or commercially packaged fruits (unless smell/mold develops)
-breads, rolls, muffins, cakes
-pie crusts, bread dough
-flour, cornmeal, nuts
-waffles, pancakes, bagels
What is bioinformatics?
The application of tools of computation and analysis to the capture and interpretation of biological data
-an interdisciplinary field which harnesses
computer science, math, physics, and biology
-responsible for the human genome project
What does the FDA division of Bioinformatics and Biostatistics do?
develops integrated bioinformatics and biostatistics capability to address increasing needs in biomarker development, drug safety, drug repositioning, personalized medicine, and risk assessment
What is biotechnology?
technology that utilizes biological systems, living organisms or parts of this to develop or create different products
What is nanotechnology
study and application of extremely small things and can be used across all other science fields.
-building materials and devices on scale of atoms and molecules
-nanotechnology helps to revolutionize many technology and industry sectors
-can make surfaces water/residue repellent, antireflective, self-cleaning, resistant to UV or infrared light, antifog, antimicrobial, scratch-resistant, lightweight, etc.
Main drivers of antimicrobial resistance
-misuse and overuse of antimicrobials
-lack of access to clean water
-sanitation and hygiene for humans/animals
-poor infection and dz prevention and control in health-care facilities and farms
-poor access to quality affordable medicines
-lack of awareness and knowledge
-lack of enforcement of legislation
Each year in the US at least ___ million people get antibiotic resistant infection and more than 35,000 people die
Antibiotic resistance mechanisms bacteria use
1) restrict access of the abx (by changing the entryways or limiting number of entryways)
2) get rid of the abx (using pumps in their cell walls)
3) change or destroy the abx with enzymes, proteins that break down the drug
4) bypass the effects of the abx (germs develop new cell processes that avoid using the abx’s target)
5) change the targets for the abx (destroy specific parts of a bacterium so the drug can no longer fit and do its job)
Global health definition
the area of study, research, and practice that places a priority on improving health and achieving equity in health for all people worldwide
-started appearing in late 1970s, came into spotlight in 1990s/2000s
-emphasizes transnational health issues, determinants, and solutions
detection methods to detect foodborne pathogens
culture based methods
immunoassays (ie. ELISA)
PCR based methods
biosensors
DNA microarray
sesame seed may be added to the “Big 8” allergens in the US
N/A
segments of US food supply chain that have significant imports
30% of produce
70% of seafood
most spices other than onion/garlic
why are there a lot of foodborne disease outbreaks linked to leafy green vegetables?
they are minimally processed and eaten without cooking
current event: cyclospora has recently been found in irrigation waters in FL, whereas before it was thought to only be associated with produce imported from outside the US/Canada
