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80 Cards in this Set
- Front
- Back
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Law governing the food industry |
Food Drug and Cosmetic Act |
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Constitutional basis for the FDA to regulate food |
Interstate Commerce Constitution--promote the general welfare of the people |
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Daily government publication to carry out the federal regulatory process |
Federal Register |
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Agency with regulations for weights and measures of food products |
NIST (national institute of standards and technology) |
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4 Steps of the Federal Regulatory Process |
Proposed rule in the Federal Register, allow for comments Change the regulation if needed Republish in the Federal Register Publish in the CFR as the final rule |
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What is the final published repository for federal laws passed by Congress and signed by the President? |
United States Code |
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Selling yogurt in a container with a large headspace |
Misbranding |
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What two laws serve as the regulatory basis for labeling foods? |
FDCA and Fair Packaging and Labeling Act (FPLA) |
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Nutrition Labeling and Education Act |
Amended the FDCA Mandated nutrition labeling Regulated health and nutrient claims States enforce Federal regulations |
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What is food? |
Articles used for food or drink for humans or animals Chewing gum Articles for components of food |
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Required parts of a label |
Ingredient declaration (with allergens declared) Name of product Name and place of business Net quantity of contents Nutrition facts |
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Meat and poultry inspection |
If <3% meat or <2% poultry, FDA If more than 3% and 2%, USDA and an inspector has to be on site |
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Eggs |
USDA inspects them, sets grading standards |
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Information Panel is where compared to the PDP |
Contiguous and to the right |
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Kosher Law elements |
Blood prohibited Certain Animals prohibited (pork) Prohibition of mixing milk and meat Passover law (kosher for passover) |
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When do additives not have to be labeled? |
If present at insignificant levels or have no function in the final product like a processing aid |
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RACC |
Reference Amount Customarily Consumed Serving size |
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Difference between Halal and Kosher |
No intoxicants in Halal |
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Kosher for passover |
Kosher for passover Haste in preparation--18 minutes Absense of leaven |
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Halal Law |
Prohibited animals Prohibition of blood Method of slaughtering/blessing No decomposing flesh No intoxicants (alcohol) |
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Standards of Identity can say |
What ingredients must be present What can be present What can't be present |
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Why standards of identity? |
Protect consumer interests, maintain a level playing field in industry |
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Benefits of food additives |
Better choices Safer and more nutritious (nitrites prevent botulism in meat, nutrients added) Lower priced foods, less waste |
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Food additives can't be used to |
Make an inferior product look better Replace a valuable food constituent that in needed in a standardized product Increase the bulk or weight of other products (economic gain) Deceive the consumer |
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Food additive |
a substance added to food which is not in and of itself a food |
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Exceptions for food additives |
GRAS Prior sanction ingredient Pesticide Color additive Dietary ingredient |
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How to be recognized as GRAS |
Based on experience from before 1958 Scientific testing and procedures--for specific usages, amounts |
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What is GRAS self affirmation? |
Companies perform research to determine if an ingredient meets the FDAs requirements for safety |
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What is a no objection letter |
FDA doesn't object to use of an additive, but doesn't necessarily approve it |
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Certified v. Non-certified colors |
Certified colors must have every batch certified Non-certified don't |
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How can the FDA enforce the CFR and FDCA |
Inspections Fines Prison sentences |
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Fines or imprisonment for what prohibited acts? |
Adulterating or misbranding Refusing entry for authorized inspections Refusal of access to required records Failure to maintain records |
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Injunction |
Court order requiring a company or individual to do or refrain from doing an act Like to stop production |
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Responses to seizures |
None, let the product be destroyed File a claim to contest the seizure Consent to seizure, negotiate to recondition the product if feasible |
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3 Product Recalls |
Stock Recovery Market Withdrawl Recall |
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Stock recovery |
Product still in control by manufacturer, internal action |
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Market withdrawal |
Product is at a lower quality than desired, won't go further than the retail level |
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Recall |
potential hazard, talk to consumers because there may be danger Still voluntary, by the company |
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3 classes of recall |
Class 1--heath/serious hazard Class 2--temporary health problems Class 3--not likely to cause problems |
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For imports FDA must have |
Notice of incoming goods -Description, manufacturer, shipper, grower, country of origin etc |
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Detention |
FDA able to detain any food of concern |
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Allergen |
Protein in food that can elicit an immune response |
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All 8 allergens |
Milk Shellfish Fish Eggs Wheat Soy Peanut Treenuts |
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4 points of allergen safe processing |
Avoid introduction of allergens Segregation Well documented cleaning Proper labels |
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SOPs |
Standard Operating Procedures |
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Labeling allergens |
In parenthesis right after the ingredient--Lecithin (soy) At the end--Contains milk, soy etc. |
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GM material |
food or ingredient derived from a GMO |
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Who approves GMOs |
USDA |
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Adulteration |
Prepared, packed or held under insanitary conditions where it might have been contaminated or injurious to health |
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cGMPs |
current good manufacturing practices |
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The regulatory requirement for Good Manufacturing Practices stems from wording in the section of the FDCA that pertains to ….? |
Sec. 402. Adulteration or Adulterated Food |
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What types of products have specific GMP regulations? |
Acidified foods Thermally processed low-acid canned foods |
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Guide for retail and food service, published every 4 years |
Food Code |
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Warehouses, facilities must register with the FDA... |
every other year |
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DAL |
Defect Action Levels When natural or unavoidable defects are in the food. Established by FDA Can't be reduced by blending |
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During inspections FDA does not have a right to |
Formulas Ingredient specifications Quality control or Quality Assurance data Complaints by consumers |
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Observations report |
After an inspection, the inspector goes through the conclusions made usually in a meeting, and report Company should respond during the meeting |
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What type or class of cleaning chemical would you use to attack type of soil? |
Fats--alkaline Minerals--acid Proteins--alkaline |
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In CIP systems, the 4 tanks used |
Alkaline cleaner Rinse Water Acid cleaner Recovery tank |
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4 sanitation parameters |
Time, concentration, mechanical work/agitation, temperature |
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HACCP principles |
Hazard analysis CCP identification Establish critical limits Monitoring procedures Corrective Actions Record-keeping and documentation Verification procedures |
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Hazards |
Chemical Physical Microbiological Radiological |
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CCP |
Critical Control Point Where a hazard can be controlled, prevented, eliminated or reduced to acceptable levels |
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Who sets quality standards |
government, industry, company, consumer |
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Costs of Quality Assurance |
Prevention costs Appraisal costs Corrective costs |
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Prevention costs |
With QA, cost of maintaining production performance at a high level where defects don't exceed tolerance |
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Appraisal costs |
With QA, cost of sampling, testing and auditing to evaluate performance |
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Correction costs |
With QA costs of correcting unsatisfactory performance, out of control conditions |
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Ways to standardize subjective measures |
Training Multiple assessments Compare to a retention sample Use photo standards |
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Specification document examples |
CoA Ingredient specifications Final product specifications |
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What info is needed to define a specification |
attribute target value range measurement method |
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List information to be included on a “Specification Deviation Form.” |
Product involved Deviation and cause Start and end times of deviation Decision to release and basis for releasing Signatures from management |
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***4 points defining a sample |
Location--optimum sampling point (early in the process) Method--how to sample Size--optimal sample size (economical but should accurately describe population) Frequency--frequency of sampling |
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Composite sample |
individual units mixed together to form one sample When homogeneity isn't an issue |
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Multi-unit sample |
individual units are analyzed separately |
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Sources of product variation |
equipment (gets old) materials (varying amounts of protein) environment operator (adjustments) |
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3 primary pest categories |
insects, rodents, birds |
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Simple metamorphosis |
cockroach egg, nymph, adult |
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Complete metamorphasis |
beetle, moth, ant, fly egg, larva, pupa, adult |
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3 lines of defense against pests |
exclusion sanitation elimination |
