Food Law Final Exam

any substance the intended use of which results or may reasonably be expected to result -- directly or indirectly -- in its becoming a component or otherwise affecting the characteristics of any food

"food additive"

regulations.gov

What website would you use to submit comments on a proposed rule?

2002

What year was the Public Health Security and Bioterrorism Preparedness and Response Act passed?

shape yolk

What are two characteristics that are observed in the voluntary process of grading eggs?

The Jungle

What book, published in 1906, was a catalyst for two major food regulations at the turn of the 20th century?

Food Safety Modernization Act

What does FSMA stand for?

Hazard analysis and critical control points

What does HACCP stand for?

Sanitation standard operating procedure

What does SSOP stand for?

Codex Alimentarius

What is the name for the organization that sets food standards, guidelines, and codes of practice for its 187+ member countries?

Biological - e. coli, salmonella Chemical - cleaners, allergens Physical - metal, plastic

3 types of hazards for each step of flow chart in HACCP plan and example of each

Prevention Inspection, Compliance, and Verification Enhanced partnerships Imports

4 main themes of FSMA

Cotton Fresh and processed fruits and vegetables Poultry Eggs Livestock and meat Dairy products Tobacco

AIMS grades:

Code of Federal Regulations

After the final rule is published, the regulation is codified in which document?

Executive branch enforce laws passed by the legislative branch; inspect and can hold, approve, or recall; write regulations

Agencies have a major role in US food regulations. What branch of government are agencies part of? Detail the role of agencies in food regulations.

Labels are required to go through USDA-FSIS approval Examples: Raised Without Antibiotics Organic Grass Fed Free-Range Raised Without the Use of Hormones

Animal Raising Claims

No, suggestions not requirements unless specific countries enforce them.

Are the guidelines set by Codex Alimentarius enforceable? Why or why not?

adulteration misbranding religious concerns

As discussed in class, what are the 3 major reasons for food laws?

Form 483

At the end of an FDA inspection, the inspector may establishment with a notice of potential violations observed during the inspection. What form is this?

What it is How it's used How it's cleaned Who does it Corrective actions Monitoring

Briefly describe what is included in an SSOP.

reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death Presence of Listeria monocytogenes in RTE products Presence of E. coli O157:H7 in raw ground beef Presence of allergens that may cause serious adverse reactions (e.g. peanuts)

Class 1 recall

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 Presence of very small amounts of undeclared allergens typically associated with milder human reactions (e.g. wheat) Small-sized, non-sharp edged foreign material

Class 2 recall

use of, or exposure to, a violative product is not likely to cause adverse health consequences Presence of undeclared ingredients such as excess water in a meat or poultry product Lack of English labeling on an imported food Minor container defect

Class 3 recall

Agricultural Marketing Service

Commonality grading done by

January 1, 2020

Compliance date for changed nutrition label

antemortem postmortem

Continuous mandatory inspection of livestock slaughter includes both _______ inspection for signs of disease in the live animal, as well as _______ inspection for signs of disease in the carcass.

Country of Origin Labeling Overseen by Agricultural Marketing Service (AMS) Effective 2005 (fish) and 2009 (other products) Requires retailers to notify their customers with information regarding the source of certain foods Food products covered by the law include: Muscle cut and ground meats: lamb, goat, and chicken Wild and farm-raised fish and shellfish Fresh and frozen fruits and vegetables Peanuts, pecans, and macadamia nuts Ginseng COOL for beef and pork was repealed in 2016; voluntary labeling is still allowed

Country of Origin Labeling

Importers must perform certain risk-based activities to ensure that imported food meets U.S. safety standards Preventive controls Not adulterated Proper allergen labeling Develop and implement FSVP for each food imported and for the supplier of each food Food that will be further processed (e.g. coffee beans) may be exempt Reevaluate every 3 years or when changes occur Hazard analysis Supplier performance evaluation and verification Corrective actions

Define Foreign Supplier Verification Program

States may operate their own meat and poultry inspection programs Must meet and enforce requirements "at least equal to" federal requirements

Describe the concept of "at least equal to" with respect to state and Federal meat inspection.

safeguard the American food supply from acts of terrorism that would harm the American populous

Describe the main objective of the Public Health Security and Bioterrorism Preparedness and Response Act.

Regional agreement among Canada, US, and Mexico Eliminate barriers to trade Promote fair trade Increase investment opportunities Securing intellectual-property rights Formal rules for resolving disputes between investors and participating countries

Describe the provisions of NAFTA.

The act of corrupting or debasing. The act of mixing something impure or spurious with something pure or genuine, or an inferior article with a superior one of the same kind. The term is generally applied to the act of mixing up with food or drink intended to be sold other matters of an inferior quality, and usually of a more or less deleterious quality. The act, process or omission to act whereby food becomes impure and unfit for consumption. Such is prohibited and regulated by federal and state statutes and agencies.

Describe the term adulteration as it relates to food regulations.

to brand falsely or in a misleading way; specifically : to label in violation of statutory requirements

Describe the term misbranding as it relates to food regulations.

Service for owner of animal animal is not sold for consumption

Describe what it means when a plant operates as "custom exempt."

Food code

Every 4 years, the FDA publishes the _______, which serves as a model for safeguarding public health and ensuring food is unadulterated and honestly presented when offered to the consumer. This document may be adopted by state and local authorities to guide food manufacturing and handling practices.

water in wine or milk

Example of economic adulterant in food

2004

FALCPA

1997

FDA Modernization Act

FDA requires allergen statement USDA does not require but encourages allergen statement

FDA vs USDA allergen statement

Safe and Suitable

FSIS Directive 7120.1 is also known as the

provides ingredient categories, description of ingredient, products it may be used in, usage level, how acceptability was determined, and any labeling requirements

FSIS Directive 7120.1, Safe and Suitable list

Food safety preventative controls

FSPC

1966

Fair Packaging and Labeling Act

2016 final rule not written by FDA yet Non-government entities currently "verifying" non-GMO products

GMO labeling

can be sold at a farmer's market cannot be sold online in MS

Give one example of where cottage foods can and cannot be sold.

All additives are initially evaluated by FDA USDA-FSIS may have stricter standards for certain additives that were previously evaluated by FDA Ingredients suitable for USDA products are listed in the "Safe and Suitable" list "safe and suitable" FSIS Directive 7120.1

How does the FDA's and USDA's "Memorandum of Understanding" work?

every 3 years

How frequent are inspections for High Risk FDA facility

continuously

How often are egg processing facilities inspected by the USDA?

A food that resembles a traditional food but is nutritionally inferior

Imitation products

Food, Drug, and Cosmetic Act

In 1938, another act was passed that corrected some of these major issues and gave the FDA greater authority in establishing food and drug regulations. What is the name of that Act?

Food Safety Modernization Act

In 2011, an Act was passed to completely overhaul the way the FDA operates. What is the name of this act?

1970

In what year was the Egg Inspection Act passed?

Name and address of manufacturer Nutrition facts panel Ingredient list Allergy statement "Intervening material" such as barcodes may not appear between the components of the information panel

Information panel

Descending order by weight Listed by common name Water is an ingredient Chemical preservatives must be listed with their function ("mold inhibitor," "preservative," etc.) Spices and flavorings may be listed by common name or as "natural flavor" or "artificial flavor" in some cases Coloring by common name or certified name ("FD&C Red No. 40") Sub-ingredients may be declared in parentheses or dispersed by order of predominance

Ingredient List

Seizures and Administrative Detentions Recalls Import Refusal Injunction Suspension of operating license

List 2 of the 5 formal enforcement actions that the FDA may take if an establishment violates regulations.

Conduct a Hazard Analysis Identify the Critical Control Points (CCP) Establish critical limits Establish CCP monitoring requirements Establish corrective actions Establish effective record keeping procedures Establish procedures for verification

List the seven principles of HACCP.

CFR 7 - Agriculture CFR 9 - Animal and animal products CFR 21- Food and drug

List the three titles of the CFR (number and title) that deal with food products.

Flow Chart

Must be developed and verified prior to beginning a HACCP plan.

National Advisory Committee on Microbiological Criteria for Foods

NACMCF

1990

Nutrition Labeling and Education Act

FDA

Of the USDA and FDA, who has the authority to issue recalls?

USDA

Of the USDA and FDA, who requires that establishments have written recall plans in place?

slaughter must be conducted as painlessly and humanely as possible and improve working conditions

One of the amendments to the Federal Meat Inspection Act was the "Humane Methods of Slaughter Act" passed in 1958. Briefly describe the provisions of this act.

GMPs SOPs

Prerequisite programs for HACCP

Brand name Statement of Identity Net contents English and metric USDA also requires handling statement and inspection legend with number

Principal Display Panel

Federal Register

Proposed rules are required to be published in the _______________. After publication, they are generally open for a comment period before the final rule is published.

Basis for serving sizes on nutrition facts panel Based on national food consumption surveys in 1970's and 1980's

Reference Amounts Customarily Consumed (RACC)

Must be suitable and adequately cleanable Capable of maintaining necessary temperatures Temperature control Preventing cross-contamination, allergen also

Requirements for FSMA transportation

1994

What year was the HACCP regulation passed that required meat and poultry plants to develop and implement HACCP plans?

3rd party raising claims or programs (i.e. Global Animal partnership, AMS Process verified or certified programs, American Heart Association (AHA) claims) Claims regarding meat and poultry production practices (i.e. claims regarding the raising of animals such as "no antibiotics administered" or "vegetarian fed") Breed claims (Berkshire, Angus, Hereford, etc) Certified claims, Certified Halal Gluten free: both certified and non certified Health claims defined in 21 CFR Subpart E, e.g. dietary saturated fat and cholesterol and risk of coronary heart disease (21 CFR 101.75) Implied Nutrition Claims for example Heart Smart, Baked Not Fried, Made without Butter Instructional or disclaimer statements concerning pathogens, such as "for cooking only"; "not tested for E. coli O157:H7"; or "For high pressure pasteurization at establishment ABC" Natural claims, e.g. "All Natural", "100% Natural" Negative claims or "free" claims (no MSG, no MSG added, no preservatives) Statements that identify a product as "organic" or containing organic ingredients Omega 3 factual statements "Whole Grain", "Made with Whole Grains", "Made with whole wheat" claims Nutritional Front of Pack statements, for example "0 grams trans fat per serving", Nutrition facts Up Front Claims of the use of non-genetically engineered ingredients Claims that are undefined in FSIS regulations or the Food Standards and Labeling Policy Book (Note: natural and negative claims are defined in the policy book but will continue to be required to be submitted for approval).

Special Statements and Claims: Approval Required

21 CFR 130-169

Standards of identity for FDA

All, 100%, pure Allergen or "Contains (name of ingredient)" statements (e.g., contains soy) AMS Grading (Prime, choice, grade A) Child Nutrition Boxes Flavor Profiles (e.g. made with fennel, teriyaki flavored, made with real cheese, only white meat) Foreign Language on domestic products Geographic claims (refer to 9 CFR 317.8(b)(1)) Green Claims/Environmental Claims Halal, Kosher (not certified) Hand pulled style/hand pinched style Handcrafted, handmade, hand slaughtered, hand crafted style Home Style For HRI only, Institutional use only, etc Nutrition Claims (defined) Ready in/Cooks in (number of minutes or seconds) Oven roasted or similar statements

Statements: Generic Approval Permitted

1957

What year was the Poultry Products Inspection Act passed?

Mississippi Department of Agriculture and Commerce

Suppose you want to open and operate a livestock slaughter facility within the state of Mississippi and you intend to sell product only within the state. You choose to apply for state inspection. Which state agency should you contact?

Cancerous

The Delaney Clause of the Food Additives Amendments forbid the approval of any additive shown to be _______.

salmonella

The Egg Safety Rule requires that certain steps are taken to prevent contamination and growth of what organism?

GRAS - generally recognized as safe; any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excepted from the definition of a food additive Prior sanctioned substances - an explicit approval granted with respect to use of a substance in food prior to September 6, 1958; Only for a specific use of a substance in food, i.e., the level, condition, product, etc

The Food Additive Amendment to the FD&C Act allows GRAS substances and Prior Sanctioned Substances to be used in food products without going through an additional approval process. Define the terms "GRAS" and "Prior Sanctioned Substances." How are they different?

FSIS Food Safety Inspection Service Agriculture, Health, and Human Services

The Main administration of the USDA that regulates food safety issues is the _______. The FDA is actually an administration within the Department of _______.

Grounds and facilities Equipment and utensils Sanitary operations Employee hygiene

The Regulatory Performance Standards for Meat and Poultry Establishments listed in 9 CFR 416 describe the general requirements for operating meat and poultry establishments to ensure wholesomeness of products. Give two examples of issues that must be addressed in a facility in order to comply with this regulation.

Administrator is authorized to utilize employees and facilities of any State in carrying out Federal functions under the Federal Meat Inspection Act

The Talmadge-Aiken Act, passed in 1962, allowed for what?

Seize product Stop Production Revoke Operating License

The USDA can take 3 levels of enforcement actions if an establishment violates their regulations. What are they?

No authority to inspect warehouses or prevent interstate commerce of harmful foods

There were several issues with the Pure Food and Drug Act that made it ineffective. List one of the major problems.

Harvey Wiley

What is the name of the head of the US Bureau of Chemistry in the late 1800s and early 1900s whose "poison squad" was highly influential in passing new food regulations?

True

True or false. The FDA has a right toconduct warrantless inspections of a food facility.

allergen testing pathogen testing detailed HACCP or FSMA plans

Two things that can be done in food facility to prevent recalls

Lot/batch # where sold production data specific name of food recalled

Two things that should be included in recall planq

1931

US vs Ten Cases, more or less, of Bred Spred

9 CFR 319, 9 CFR 381, and the Food Standards and Labeling Policy Book and on the FSIS website

USDA standards of identity

low hazard foods produced in private homes jellies, bread, fruits, veggies

What types of foods may be sold as cottage foods? Give two examples of cottage foods.

APHIS-USDA

What US government agency would you deal with to determine the rules to import apples from New Zealand?

Government Publishing Office

What US government office is responsible for production and distribution of all the official information products of the Federal government?

Meat Inspection Act

What act, passed in 1906, requires continuous mandatory inspection for meat and poultry slaughter?

Pure Food and Drug Act

What act, passed on June 30, 1906, was intended to prevent the manufacture, sale, or transportation of adulterated or misbranded or poisonous or deleterious foods, drugs, medicines, and liquors?

Judicial Legislative Executive

What are the 3 branches of the US Federal government?

Intentional Unintentional Economic

What are the 3 mains types of adulteration?

maximum levels of natural or unavoidable defects in foods for human use that present no health hazard

What are the FDA's defect action levels?

Quality manager HACCP certified person Floor worker Management

Who should be on a HACCP team?

Inspections of foreign suppliers may be done by accredited third parties FDA issued a final rule for the procedures that certification bodies must follow to be recognized by FDA Purpose is to ensure competence and independence of accreditation bodies and third-party certification bodies

Why are third-party inspections and certifications important under FSMA?

Time Money Extensive Product more likely to injure consumers the longer it's out on the shelves

Why is it important to have a recall plan in any food facility, whether required or not?

2011

Year FSMA passed?

Public private

_______ law deals primarily with the relationship between citizens and the government, whereas _______ law deals with relationships among citizens, companies, or organizations.

E. coli in beef salmonella in eggs

example of unintentional adulterant in food product

When the nature of the food is obvious, a fanciful name commonly used and understood by the public may be used ex. vanilla wafers

fanciful name

<20 ppm gluten allowed in products that carry this label Applies to FDA-regulated products Foods that are either manufactured or naturally gluten-free

gluten free

Food contact surface

indirect food additive

its labeling or advertising is false or misleading is offered for sale under the name of another food is an imitation of another food but the label does not bear the word "imitation" its container is made or filled to be misleading its label does not provide i) the name and place of the manufacturer, and ii) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count

misbranding

A product containing no artificial ingredient, chemical preservative, or added color and is only minimally processed, meaning that the product was processed in a manner that does not fundamentally alter the product

natural labeling

Organic is a labeling term for food or other agricultural products that have been produced using cultural, biological, and mechanical practices that support the cycling of on-farm resources, promote ecological balance, and conserve biodiversity in accordance with the USDA organic regulations.

organic

100% - only organic ingredients Organic - 95% organic ingredients, other 5% can be nonorganic agricultural products that are not commercially available as organic and/or nonagricultural products that are on the National List Made with Organic - contains at least 70% organically produced ingredients, other 30% have detailed constraints regarding the ingredients that comprise the nonorganic portion. Specific Ingredient Listings- organic ingredients may be listed in the ingredient statement of products containing less than 70 percent organic contents

types of organic foods

validation is the "why it's done" (federal guidelines, scientific data, etc) verification is the "is it done correctly"

validation vs verification