Food Law- Final Exam

NEW ENFORCEMENT TOOLS

1) Administrative detention 2) Records inspection 3) Mandatory recall 4) Suspension of food facility license 5) Authority to deny entry

The keystone of FSMA, like HACCP, is the development of risk‐based preventive controls for food facilities. Food facilities are required to develop and implement a written plan for preventive controls and a writ ten recall plan. This involves:

1) Evaluating the hazards that could affect food safety; 2) Specifying what preventive steps, or controls, will be put in place to signifi cantly minimize or prevent the hazards; 3) Specifying how the facility will monitor these controls to ensure they are working; 4) Maintaining routine records of the monitoring, and 5) Specifying what actions the facility will take to correct problems that arise.

T/F? State agencies regulating retail food establishments are required to adopt the most recent version of the FDA Food Code.

False! (not required- encouraged to)

T/F: The Federal Meat Inspection Act of 1906 did include poultry inspections.

False! Did not.

T/F? The def. of "food", according to the U.S. Code (USC), does not include food or drink for animals.

False! Does include.

T/F? Prior to the Pure Food and Drug Act of 1906, food laws never existed in the U.S.

False! Existed.

T/F? A food is considered misbranded/adulterated until proven safe by the FDA.

False! until proved safe by food business.

Statutory Law

Federal Food, Drug, and Cosmetic Act (The F, D, & C Act of 1938)

What Happens If You Are Depleted In Your Endocannabinoid System?

The gut-brain connection is no joke; it can link anxiety to stomach problems and vice versa. Have you ever had a "gut-wrenching" experience? Do certain situations make you "feel nauseous"? Have you ever felt "butterflies" in your stomach? We use these expressions for a reason. The gastrointestinal tract is sensitive to emotion. Anger, anxiety, sadness, elation — all of these feelings (and others) can trigger symptoms in the gut.

Direct food additive

food additives are those that are added to a food for a specific purpose in that food. For example, xanthan gum -- used in salad dressings, chocolate milk, bakery fillings, puddings and other foods to add texture -- is a direct additive. Most direct additives are identified on the ingredient label of foods.

Indirect food additive

food additives are those that become part of the food in trace amounts due to its packaging, storage or other handling. For instance, minute amounts of packaging substances may find their way into foods during storage. Food packaging manufacturers must prove to the U.S. Food and Drug Administration (FDA) that all materials coming in contact with food are safe before they are permitted for use in such a manner.

What Is a Color Additive?

food ingredients additives and colors - vanilla chocolate and strawberry milkshakes A color additive is any dye, pigment or substance which when added or applied to a food, drug or cosmetic, or to the human body, is capable (alone or through reactions with other substances) of imparting color. FDA is responsible for regulating all color additives to ensure that foods containing color additives are safe to eat, contain only approved ingredients and are accurately labeled.

HACCP: stands for

hazard analysis critical control points

Sanitation controls include procedures, practices, and processes to ensure that the facility is maintained in a sanitary condition adequate to significantly mini- mize or prevent hazards such as environmental pathogens, biological hazards due to employee handling, and food allergen hazards. Sanitation controls must include, as appropriate to the facility and the food, procedures, practices, and processes for the:

i) Cleanliness of food‐contact surfaces, including food‐contact surfaces of utensils and equipment; ii) Prevention of allergen cross‐contact and cross‐contamination from insanitary objects and from personnel to food, food packaging material, and other food‐contact surfaces and from raw product to processed product.

Process controls include procedures, practices, and processes to ensure the control of parameters during operations such as heat processing, acidifying, irradiating, and refrigerating foods. Process controls must be included, as appropriate to the nature of the applicable control and its role in the facility's food safety system:

i) Parameters associated with the control of the hazard; and ii) The maximum or minimum value, or combination of values, to which any biological, chemical, or physical parameter must be controlled to significantly minimize or prevent a hazard requiring a process control.

T/F? FDA pre-approves food product labels prior to the food entering interstate commerce.

False! (USDA)

T/F? The USDA provides USDA Certified Organic labels only for USDA regulated products.

False! (for all products)

A vulnerability assessment must occur at each step in the facility's process-- Each step is evaluated for:

(1) the severity and scale of the potential impact on public health (e.g., volume of product, number of exposures, potential agents of concern), (2) the degree of physical access to the product and barriers in place, and (3) the ability to successfully contaminate the product Accessibility-> <-Vulnerability

Today three basic strategies can be followed for demonstrating adulteration i.e.

--By demonstrating the presence of foreign substance or a marker in the commodity --By demonstrating that a component is deviated from its normal level and --By demonstrating that a profile is unlikely to occur

National Response Framework (NRF)

A scalable, flexible, and adaptable system that coordinates the key roles and responsibilities of response participants throughout the country. Two food hazard-related incident annexes: --Biological Incident Annex (response to a disease outbreak of known or unknown origin) - coordinated by HHS --Food and Agriculture Incident Annex (response to emergencies involving the agriculture and food systems determining the impact on food, water, wildlife, and humans) - coordinated by USDA and HHS

5 - Take the FDA ALERT Food Defense Awareness Training

ALERT: (Assure, Look, Employees, Reports, Threats) a series of online modules is designed to enhance upper level stakeholder knowledge on food defense With annual training, managers will better respond to food defense threats and will (hopefully) go to work each day anticipating future risks.

DHS and food defense

DHS is responsible for terrorism as well as "a much wider portfolio of natural, technological, and intentional hazards" CBRNE: chemical, biological, radiological/nuclear, and explosive. Several agencies, offices, and directorates have been established to respond to biosecurity crises of which food safety is included. The Science and Technology (S&T) Directorate --houses the Homeland Security Advanced Research Projects Agency (HSARPA), which manages the Chemical/Biological Defense Division The Chem/Bio Defense Division increases preparedness for chemical or biological threats through awareness, surveillance, and countermeasures. The Office of Health Affairs (OHA) coordinates the preparation for and response to medical- related emergencies, leading DHS's biodefense and food, agriculture, and veterinary defense activities (including the BioWatch early detection program).

3 - Follow the rules of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act)

Ensuring that foreign suppliers are providing prior notice of food shipments to FDA Ensuring that records are kept regarding foreign suppliers (and that the suppliers themselves are keeping records) Confirming that supplies are being procured from registered facilities

Steps for a successful CARVER + Shock analysis

Establishing parameters (What are you protecting? What are you protecting against? etc.) Assembling experts (Subject matter experts from food science, epidemiology, microbiology, etc.) Detailing the food supply chain (A flow chart of the system and its components/nodes) Assigning scores (Once broken down into its smaller parts, rank based on CARVER + Shock principles) Applying what has been learned (Make changes in the critical nodes) For each node in the production system, a score is assigned for each C, A, R, V, E, R, and Shock parameter (scaled 1-10). Then, decisions are made by adding up each value of C, A, R, V, E, R, and Shock for each node, thus giving managerial staff starting point to reduce vulnerability.

Defining Food Defense

Food defense involves the protection activities, and/or the security assurance process or procedures that deliver product safety with regard to intentional acts of adulteration FDA expands this definition to "the effort to protect food from intentional acts of adulteration where there is an intent to cause wide scale public harm" (Department of Health and Human Services, 2016a)

Food defense, nationally, starts at DHS

The ways in which the United States prepares for a national food safety threat (and most biohazards in general) is a conglomeration of agencies, directorates, and personnel. DHS leverages resources within federal, state, and local governments and more than 87,000 different governmental jurisdictions carry out the mission at these levels. Much of what the Department of Homeland Security (DHS) does is based on Homeland Security Presidential Directives (HSPDs).

4 - Undergo a company-wide CARVER + Shock analysis

This tool can be used to assess the vulnerabilities within a system or infrastructure to an attack Vulnerability is assessed for a company as a whole, the vulnerability of the building, or the vulnerability of the supply chain By examining a company through the seven attributes of CARVER + Shock, company leadership can better anticipate how "attractive" the company is to terrorists or subversive entities.

Several systems for countering intentional contamination threats have been developed, including:

Threat assessment critical control points (TACCP) Vulnerability assessment critical control points (VACCP), The food protection risk matrix The NSF fraud protection model The USP preventative food fraud management system, and The CARVER + Shock tool.

DHS FD mandates carried out by USDA

USDA created the Office of Homeland Security and Emergency Coordination (OHSEC) in 2011 with six divisions National Surveillance Unit in APHIS: protects and monitor the health of livestock and poultry. FSIS: works to prevent, prepare for, respond to, and recover from non-routine emergencies resulting from intentional and unintentional contamination" in meat, poultry, and egg products --Also assesses food supply vulnerabilities, monitors the food supply for intentional contamination, and works with other government agencies to dictate proper responses Food Defense and Emergency Response division serves as the lead coordinating body in the development of the infrastructure and capacity to prevent, prepare for, and respond to terrorism aimed at the U.S. food supply

What happens when Endocannabinoid System is out of balance?

"All told, inflammation is involved in at least 8 of the top 10 leading causes of death in the United States today," writes Dr. Slavich. "Understanding how inflammation promotes poor health, and how and when we can intervene to reduce inflammation-related disease risk, should thus be a top scientific and public priority."

Using Your ECS Knowledge for a Healthier Tomorrow-- What can be treated through ECS therapies??

"More importantly, modulating the activity of the endocannabinoid system turned out to hold therapeutic promise in a wide range of disparate diseases and pathological conditions, ranging from mood and anxiety disorders, movement disorders such as Parkinson's and Huntington's disease, neuropathic pain, multiple sclerosis and spinal cord injury, to cancer, atherosclerosis, myocardial infarction, stroke, hypertension, glaucoma, obesity/metabolic syndrome, and osteoporosis, to name just a few." (The Endocannabinoid System as an Emerging Target of Pharmacotherapy)

what is a food additive?

"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."

Why weren't the cited guidance documents and warning letters used to convict the case against Trader Joe's?

"the standardization of milk simply means that a company cannot pass off a product as 'milk' if it doesn't meet the regulatory definition of milk. Trader Joe's has not, by calling its product 'soymilk', attempted to pass off those products as the food that the FDA has standardized (milk)". The FDA's position: "the standard of identity of milk is in 21 CFR 131.110. the agency does not have a specific regulation that authorizes the use of the names you referenced (i.e., 'almondmilk', 'soymilk', 'cashewmilk', etc.) FDA's regulations regarding common/usual names for food, including those names FDA has established by regulation, can be found in 21 CFR Part 102."

Changes in the 'food standards of identity' are through:

'Notice and Comment' Process in the Federal Register

FSMA- FOUNDATIONAL RULES /HARPC**

(FSMA IN CENTER) -Produce Safety -Preventative Controls for Human Food -Preventative Controls for Animal Food Foreign Supplier -Verification Program (HAZARD ANALYSIS AND RISK-BASED PREVENTATIVE CONTROLS -- HARPC)

Basic premise= nothing can contact food

(including packaging) unless there is a regulation allowing the item to contact food

health claim must always ?

**Health claim must always relate food or its ingredient to a disease or health-related condition.

2 - Becoming fully compliant with the IA Rule

**Most important - develop and have documented a Food Defense Plan** Contents of a Food Defense Plan (21 CFR § 121.126 (b)): 1. The written vulnerability assessment, including required explanations, to identify significant vulnerabilities and actionable processes. 2. The written mitigation strategies, including required explanations. 3. The written food defense monitoring procedures for the implementation of the mitigation strategies. 4. The written food defense corrective actions. 5. The written food defense verification procedures.

FDA Food Safety Regulations and Model Codes from Farm to Fork- Retail Food Establishments:

- FDA Food Code* Inspection and licensing of restaurants and grocery stores are typically handled by local and county health departments. However, the FDA serves as a technical consultant to state and local agencies by publishing the FDA Food Code. Most states adopt these model provisions.

FDA Food Safety Regulations and Model Codes from Farm to Fork- Food Manufacturing and Processing:

- Facility Registration (Section 415, FD&C Act) - Low Acid Canned Foods (21 CFR Part 113) - Acidified Foods* (21 CFR Part 114) - Preventive Controls with updated GMPs* (21 CFR Part 117) - Juice HACCP* (21 CFR Part 120) - Seafood HACCP* (21 CFR Part 123)

FDA Food Safety Regulations and Model Codes from Farm to Fork- Farms:

- Produce Safety Rule* (21 CFR Part 112) - Egg Safety Rule (21 CFR Part 115 and 118)

Poultry Products Inspection Act

- Provides for inspection of poultry and poultry products - Regulates processing and distribution of poultry to prevent the sale of misbranded or adulterated products - Ensures foreign products are processed under equivalent U.S. standards

Eggs Products Inspection Act

- Provides for the inspection of certain egg products, qualities and uniform standards for eggs. - Regulates the processing and distribution of eggs and egg products.

Federal Meat Inspection Act

- Requires the USDA to inspect all food animals when slaughtered and processed - Ensures foreign products are processed under equivalent U.S. standards

HACCP (Hazard Analysis and Critical Control Point)*- USDA-FSIS

- USDA-FSIS requires that all established meat and poultry plants implement an approved HACCP system (9 CFR 417) - All plants must have a written sanitation program (9 CFR 416) - A state-federal cooperative inspection program exists that requires state inspections to be "at least equal to" the federal program

Label the food product with required information: A clear cereal box with bowl of cereal illustration below

-At the top- statement of identity -Right below SOI- name and place of manufacturer -Below illustration- net quantity

INTENTIONAL ADULTERATION

--"Mitigation Strategies to Protect Against Intentional Adulteration" • Aimed at preventing intentional adulteration from acts intended to cause wide-scale harm to public health, including acts of terrorism targeting the food supply --Key provisions: • Vulnerability assessment • Mitigation strategies • Mitigation strategy management • Training and recordkeeping

VOLUNTARY NATIONAL RETAIL FOOD REGULATORY PROGRAM STANDARDS

--'Retail program standards': • Define what constitutes a highly effective and responsive program for regulation of foodservice and retail food establishments • Intended to reinforce proper sanitation (good retail practices) and operational and environmental prerequisite programs while encouraging regulatory agencies and industry to focus on the factors that cause and contribute to foodborne illness --Enrollment • Government agencies and organizations responsible for regulation or oversight of the food establishments that sell, serve, or vend food directly to the public are eligible to enroll

Current- what would need to be met*- FDA is announcing a number of important new steps and actions to advance our consideration of a framework for the lawful marketing of appropriate cannabis and cannabis-derived products under our existing authorities. These new steps include:

--A public hearing on May 31, as well as a broader opportunity for written public comment, for stakeholders to share their experiences and challenges with these products, including information and views related to product safety. --The formation of a high-level internal agency working group to explore potential pathways for dietary supplements and/or conventional foods containing CBD to be lawfully marketed; including a consideration of what statutory or regulatory changes might be needed and what the impact of such marketing would be on the public health. --Updates to our webpage with answers to frequently asked questions on this topic to help members of the public understand how the FDA's requirements apply to these products. --The issuance of multiple warning letters to companies marketing CBD products with egregious and unfounded claims that are aimed at vulnerable populations.

RETAIL PROGRAM STANDARDS- 6. Compliance and Enforcement

--Activities result in follow-up actions for out-of-control risk factors and timely correction of code violations --Encompasses all voluntary and regulatory actions • Voluntary = on-site corrections at time of inspection, voluntary destruction of product, risk control plans, and remedial training • Regulatory = warning letters, re-inspection, citations, administrative fines, permit suspension, and hearings

FOOD WASTE

--Approximately 1/3 of the food produced in the world for human consumption each year is lost or wasted. --1.3 billion tons per year; $1 Trillion in value -- Environmental Significance of the 33.79 Million Tons of Food Waste --Food production in the U.S. accounts for 10% of the energy consumed --Food production in the U.S. accounts for 50% of all our land --Food production in the U.S. accounts for 80% of our fresh water use

RECORDS INSPECTION

--Expands the records food producers are required to maintain --FDA can now compel food producers to share records about potentially hazardous foods --Request to inspect records in addition to the records required under the 7 foundational rules or as part of GMPs.

CBD's, Medical Marijuana, and the Food and Drug Administration- Definitions:

--Hemp and Marijuana are legal definitions: Hemp is marijuana that is less then .3% THC Hemp that contains more than .3% THC is considered marijuana --What are CBD's?: "CBD" has a dual definition - means specifically cannabidiol the molecule and is also used to reference the non-THC molecules in hemp/ marijuana A CBD tincture can contain many other molecules that are non-psychoactive like CBN, CBG, CBV and others

DEFINING THE LABEL

--Key is to distinguish btwn labeling & advertising (misleading/misbranding) --Nearly any written material w a food product can be captured under 'label' and 'labeling' definitions • Example: pamphlets, booklets, etc., displayed in conjunction with the product • Exception: a business carrying two related products is not sufficient to function as a connection between the products

SANITARY TRANSPORT OF FOOD-- *Focus on practices that create safety risks rather than quality* Key requirements

--Key requirements: • Vehicles and transportation equipment: Design and maintenance of vehicles and transportation equipment to ensure safety of food • Transportation operations: Measures must be taken during transportation to ensure food safety (E.g., adequate temperature controls, preventing cross-contamination of RTE and raw foods, preventing allergen cross-contact) • Training: Training of carrier personnel in sanitary transportation practices and documentation of training • Records: Maintenance of records of written procedures, agreements, and training

Globalized food supply

--Participating in the world food market requires that one meets the expectations of trading partners --That is, food exporters must comply with the standards imposed by the importing nation where the food will be consumed --*Consequently, a company intending to export its product must comply with both the domestic and foreign laws.*

ADMINISTRATIVE DETENTION

--Provides a means thru which FDA can hold adulterated/misbranded food & prevent it from reaching the marketplace --Prior to FSMA, statute required "credible evidence or info" of serious health hazard. (limited to repeat violations or "glaring" violations) --FSMA requires a "reason to believe food is adulterated/misbranded" (any notion can lead to up to a 30-day hold by the FDA)

PSR- QUALIFIED END USER

--Qualified end-user is either: • The consumer of the food; OR • A restaurant or retail food establishment that is located: -In the same state as the farm -In the same Indian reservation as the farm -Not more than 275 miles away • Farm required to: -Include name and complete business address either on label of the produce that would be otherwise covered (if required under FDCA and its implementing regulations); OR -Display the same information at the point-of-purchase

ACCREDITED THIRD-PARTY CERTIFICATION- requirements/exemptions

--Requirements: • Ensure their audit agents are competent and objective • Verify the effectiveness of corrective actions to address identified deficiencies in audited entities • Assess and correct any problems in their own performance • Maintain and provide FDA will access to records required to be kept under their program --Exemptions: • Mandatory import certification does not apply to: • Alcoholic beverages manufactured by foreign facilities • Certain meat, poultry, and egg products that are subject to USDA oversight at the time of importation

FSMA - THE LAW

--Title I - Improving Capacity to Prevent Food Safety Problems (*DOES NOT APPLY TO: Juice, Seafood, Low-Acid Foods HACCP*) --Title II - Improving Capacity to Detect and Respond to Food --Title III - Improving the Safety of Imported Food --Title IV - Miscellaneous Provisions *Requires guidance documents, promulgation of regulations, and final rules in order to implement the law.*

PSR- QUALIFIED EXEMPTION (QE)

--Two requirements: • Farm must have food sales averaging <$500k per year during previous 3 years • Farm's sales to qualified end-users must exceed sales to others

SANITARY TRANSPORT OF FOOD-- Waivers

--Waivers: • National Conference on Interstate Milk Shipments Grade "A" Milk Safety program • Food establishments holding valid permits issued by relevant regulatory authority (state or tribal agency), when engaged as receivers, shippers, and carriers in operations in which food is relinquished to customers after being transported from the establishment (E.g., restaurants, supermarkets, home delivery operations)

PRODUCE SAFETY RULE

--What is 'covered' produce?: • Raw agricultural commodities (Examples: apples, blackberries, cucumbers) --Produce NOT covered: • 'Rarely consumed raw' (Examples: asparagus, beets, corn)

Raw agricultural commodities include which of the following? (Don't include?):

-A whole apple that has been washed -Bagged oranges with their peel intact -A carton of strawberries (any food in its raw or natural state, including all fruits that are washed, colored, or otherwise treated in their unpeeled natural form prior to marketing.) Doesn't include: Sliced cantaloupe sold by the pound

ADDED SUBSTANCES: TOLERANCES**

-Created to ease FDA's burden under "may render injurious" standard -Only those added substances that're unavoidable thru GMP's or are "necessary in the production of food" may be subject to tolerances. -3 criteria *(meaning to add it, higher standard/lower threshold)*

Which of the following products USDA doesn't have regulatory power over?

-Dried whole eggs -Frozen egg yolks -**Shell eggs** -Liquid egg whites

Which claim is an equivalence claim?

-Healthy, contains 3 g. of fat (nutrient- implied claims) -**Contains as much calcium as an 8 ounce glass of milk** -Reduced fat (nutrient- relative claims)

If imported, please choose which of the following would require a FSVP Plan:

-Juice -Alcoholic beverages -**Cheese** -Fish

Types of production claims:

-Nutrient- "40% Omega-2 fatty acids, 10 mg per capsule" -Health- "Calcium reduces osteoporosis risk" -Structure function- "Helps promote urinary tract health"

Which of FDA regulated products are subject to mandatory HACCP?

-Shell eggs -Bottle water -**Juice**

what is food quality?

-Standards- regulations -Ingredients - type and quality -Quality assurance - color, texture, flavor

Please choose which of the following is not included in the 'three sisters' organizational structure.

-World Organization for Animal Health (OIE) -**Office of the U.S. Trade Representative** -International Plant Protection Convention (IPPC) -Codex Alimentarius Commission (Codex)

Which is an example of a health claim?

-antioxidants maintain cell integrity (structure/function claims) -**diets low in sodium may reduce the risk of high blood pressure** -good source of oat bran (nutrient- implied claims) -helps promote urinary tract health (structure/function claims)

False statements about indirect food additives-

-are intended to become a component of the food (not true) -are not regulated by the F, D, & C Act (are regulated) -are synonymous with non-added substances (not true) Non-added substances= An inherent natural constituent of the food, not the result of environmental, agricultural, industrial, or other contamination (a "naturally occurring substance" is a non-added substance (Anderson Seafood)

USDA food-related products:

-meat: >3% of product is meat -poultry: >2% of product is poultry -processed egg products: dried, liquid, frozen

Dietary supplements- registration

-no registration with FDA required -no FDA approval required before producing/selling -manufacturers must make sure that product label info is truthful & not misleading --FDA primarily regulates thru post-market enforcement --EXCEPTION, a 'new dietary ingredient', requires 75-day pre-market notification • A dietary ingredient not marketed in the U.S. before October 15, 1994 and does not include any dietary ingredient which was marketed in the U.S. before October 15, 1994. • Required for any supplement containing a new dietary ingredient

Specialized regulations- eggs-

-• USDA = governs laying facilities and grading; enforces production facilities of egg products, liquid, frozen, and dehydrated under EPI Act • FDA = laying hens' diet and shelled eggs • What happens when an outbreak is linked to shell eggs? = recall- salmonella (FDA)

What should/must a company do to create a biosecure environment and ensure food defense?

1) Follow the guidelines of the Food Safety Modernization Act (FSMA) 2) Become fully compliant with the Mitigation Strategies Rule (a.k.a. the Intentional Adulteration (IA) Rule) 3) Follow the rules of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) 4) Undergo a CARVER + Shock analysis 5) Take the FDA ALERT Food Defense Awareness Training

Based on discussion with Dr. Jarrod Kersey from Simmons Foods, list the 3 things to consider when determining what type of 'claim' you can make on your product label.

1) Regulatory 2) Who is the product intended for 3) Landscape

Preliminary HACCP steps

1. Assemble the HACCP team 2. Describe the food and its distribution 3. Describe the intended use and consumers of the food 4. Develop a flow diagram which describes the process 5. Verify the flow diagram

Compromise- To ease the process, nations began to agree to accept imported food if:

1. it met the standards of the exporting nation 2. the standards and their administration in the exporting nation were determined by the importing nation to be equivalent to the standards of the importing nation. Standards- International standards are likely to impact domestic standards. That is, if a nation wants its firms to participate in the world food trade, the firms will need to comply with the emerging international standards.

Three Main Points on the Endocannabinoid System

1. It is very old. Humans share the ECS with almost all other life on the plant. 2. It appears to the master regulatory system for most life on the planet. 3. It is a RESOURCE DRIVEN system.

the levels of law in order from highest in the hierarchy of law to lowest

1. constitution 2. statutes 3. regulations 4. case law

The FDCA recognizes three categories of food constituents and imposes substantially different regulatory and technical requirements for each category as follows:

1. substances intentionally added to food, both directly and indirectly, 2. substances that are natural components of food, and 3. substances that may contaminate food.

Timeline of cell-cultured meat:

1912- first appearance- French Biologist Alexis Carrel keeps chicken heart muscle alive in a Petri dish 1995- US FDA approves the use of commercial in vitro meat production 1999- Willem van Eelen secures the first patent for in vitro meat 2013- First in vitro hamburger developed by Dutch researcher is taste-tested

Macaroni products are defined in the U.S. CFR in Title 21, Ch. 1, Part 139, Sect. 110. Give the appropriate CFR citation for this product.

21 CFR § 139.110 (2018)

Definition of dietary supplement

21 U.S.C. § 321(ff) 1) Means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: A. A vitamin; B. A mineral; C. An herb or other botanical; D. An amino acid; E. A dietary substance for use by man to supplement the diet by increasing the total dietary intake; or F. A concentrate, metabolite, constituent, extract, or combination of ingredient described in clause A-F

Waste on the Farm

6 Billion lbs. of fresh produce are left in the fields each year

How do USDA food labeling regulations address products for foreign commerce in non-English speaking countries?

9 CFR § 317.7 (2018) Labels to be affixed to packages of products for foreign commerce may be printed in a foreign language and may show the statement of the quantity of contents in accordance with the usage of the country to which exported and other deviations from the form of labeling required under this part may be approved for such product by the Administrator in specific cases: Provided, (a) That the proposed labeling accords to the specifications of the foreign purchaser, (b) That it is not in conflict with the laws of the country to which the product is intended for export, and (c) That the outside container is labeled to show that it is intended for export; but if such product is sold or offered for sale in domestic commerce, all the requirements of this subchapter apply. The inspection legend and the establishment number shall in all cases appear in English but in addition, may appear literally translated in a foreign language.

WHAT IS A PATENT?

A patent is a grant from the federal government that gives the inventor the legal right to exclude others from making, using, and selling the invention for a limited time.

A drug is defined as:

A substance recognized by an official pharmacopoeia or formulary. A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. A substance (other than food) intended to affect the structure or any function of the body.

Where is the Food Safety and Inspection Service (FSIS) housed?

Dept. of Agriculture

The "may render injurious" standard of adulteration applies to what?

Added substances

The difference between a food additive & a color additive is:

Determined by the intended use of the additive

FDA Guidance

Additionally, it's unlawful under the FD&C Act to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived. This is because both CBD and THC are active ingredients in FDA-approved drugs and were the subject of substantial clinical investigations before they were marketed as foods or dietary supplements. Under the FD&C Act, it's illegal to introduce drug ingredients like these into the food supply, or to market them as dietary supplements. This is a requirement that we apply across the board to food products that contain substances that are active ingredients in any drug. The FDA's role in the regulation of drugs, including marijuana and marijuana-derived products, also includes review of applications to market drugs to determine whether proposed drug products are safe and effective for their intended indications. The FDA's drug approval process requires that clinical trials be designed and conducted in a way that provide the agency with the necessary scientific data upon which the FDA can make its approval decisions. Without this review, the FDA cannot determine whether a drug product is safe and effective. It also cannot ensure that a drug product meets appropriate quality standards. For certain drugs that have not been approved by the FDA, such as marijuana, the lack of FDA approval and oversight means that the purity and potency of the drug may vary considerably.

RETAIL PROGRAM STANDARDS- 5. Foodborne Illness and Food Defense Preparedness and Response

An established system to detect, collect, investigate, and respond to complaints and emergencies that involve foodborne illness, injury, and intentional or unintentional food contamination --Requirements: • Investigative procedures • Reporting procedures • Trace-back procedures • Recalls • Media management • Data review and analysis

RETAIL PROGRAM STANDARDS- 7. Industry and Community Relations

Applies to industry and community outreach activities used by a retail food regulatory program to about solicit a broad spectrum of input about activities, communicate sound public health food safety principles, and foster and recognize community initiatives

RETAIL PROGRAM STANDARDS- 9. Program Assessment

Applies to the process used to measure the success of a jurisdiction's program in reducing the occurrence of foodborne illness risk factors to enhance food safety and public health in the community • Requires a Risk Factor Study every 5 years

A PATENT MUST:

BE PATENTABLE SUBJECT MATTER, BE USEFUL, NOVEL, NONOBVIOUS, AND PROVIDE ENABLEMENT PATENTABLE SUBJECT MATTER: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title. USEFUL: To be regarded as useful, an invention or improvement must contain some identifiable benefit from its purpose. NOVEL: To be regarded as "novel," an invention must be new. NONOBVIOUS Would someone with "ordinary skill in the art" feel this invention or improvement was obvious? If the invention is reasonably predictable, it is probably obvious and thus not patentable subject matter. ENABLEMENT: The enablement requirement refers how to make and how to use the invention.

Microbial Contaminant:

Bacterial, Fungai, Parasite: Bacillus cereus, Clostridium botulinum toxins, Clostridium perfringens (welchii), Salmonella, Shigella sonnei, Staphylococcus aureus, Streptococcus pyogenes Aspergillus flavus (aflatoxin), Claviceps purpurea (Ergot), Fusarium sporotrichiodies, Penicillium islandicum Trichinella spiralis, Ascaris lumbricoides, Entamoeba histolytica, Ancylostoma duodenale (hookworm)

Standards of identity do what?

Establish the common/usual name for a food, Define the basic nature of the food, Allow the use of optional ingredients

Farm Bill 2018

Basically legalized hemp nationally Left States to determine their own regulatory Opened the door for big box retail Opened the door for infused beverage market

USDA vs. FDA inspections

Basically- USDA responsible for safety of meat, poultry, & egg products, while FDA responsible for all other foods. FSIS conducts daily inspections of food in its domain, whereas FDA inspections have no regular schedule. FSIS inspects 100% of all imports under its jurisdiction, & tests 5% of these for pathogens/residues, while the FDA doesn't inspect imports without cause. this means that seafood products can enter US with no inspection whatsoever.

CARVER + SHOCK breakdown:

C: Criticality - a measure of public health and economic impacts of an attack A: Accessibility - ability to physically access and egress from target R: Recuperability - ability of a system to recover from an attack V: Vulnerability - ease of accomplishing attack E: Effect - amount of direct loss from an attack as measured by loss in production R: R: Recognizability - ease of identifying target Shock: the combined health, economic, and psychological impacts of an attack

The food additive category known as 'prior-sanctioned' substances:

Can be amended to remove substances but not added to.

Judge decision:

Clears Trader Joe's Soymilk Labels -term 'soymilk' is not misleading, says judge in Trader Joe's lawsuit. -accordingly, the court dismissed the plaintiffs' claims related to soy milk labeling but allowed to continue claims related to chemical preservatives & evaporated can juice

FAO + WHO =

Codex -Codex has established 221 commodity standards (ex. canned applesauce commodity standard on Bb) U.S. Codex Office is housed in the USDA

FDA has regulations specifying Good Manufacturing Practices (GMPs) for the food processors that FDA is responsible for regulating. Current GMPs address nine major topic areas. List the topic areas and provide an example of each.

Current Good Manufacturing Practices consists of 9 sections: 21 CFR § 117 (2018) 1) Personnel §117.10 (disease control, cleanliness - maintaining adequate personal cleanliness) 2) Plant and grounds §117.20 (grounds, plant construction and design - provide adequate ventilation or control equipment..) 3) Sanitary operations §1117.35 (pest control, sanitation of food-contact surface - single- service articles must be stored, handled, and disposed of in a manner that protects against contamination..) 4) Sanitary facilities and controls §117.37 (water supply, plumbing - properly convey sewage and liquid disposable waste from the plant) 5) Equipment and utensils §117.40 (equipment and utensils must be designed, constructed, and used appropriately to avoid the adulteration of food..) 6) Processes and controls §117.80 (manufacturing operations, raw materials and other ingredients - frozen raw materials and other ingredients must be kept frozen) 7) Warehousing and distribution §117.93 (storage and transportation of food must be under conditions that will protect against allergen cross-contact..) 8) Holding and distribution of human food by-products for use as animal food §117.95 (during holding, human food by-products for use as animal food must be accurately identified) 9) Defect action levels §117.110 (the manufacturer, processor, packer, and holder of food must at all times utilize quality control operations..)

What federal agency is the frontlines of food defense nationally?

Department of Homeland Security

Which amendment to F, D, & C Act of 1938 places dietary supplements into a special category under 'foods'?

Dietary Supplement Health and Education Act of 1994 (DSHEA)

1994 regulation:

Dietary Supplement Health and Education Act: • Restricted the FDA's ability to impose strict controls on dietary supplements • DEFINED 'dietary supplements' and *set statutory framework for making claims on products* • New GMPs for dietary supplements (21 CFR Part 111)

What agency sets the standards for pesticide residues under the Pesticide Residues Amendment?

EPA

International considerations

Each nation administers its own food laws/standards

Is economic or indirect adulteration closely related to misbranding?

Economic!

USDA jurisdiction- products- eggs

Egg products processing plants (egg breaking and pasteurizing operations) are under USDA jurisdiction. Products that meet USDA's definition of "egg product" are under USDA jurisdiction. The definition includes dried, frozen, or liquid eggs, with or without added ingredients, but mentions many exceptions. The following products, among others, are exempted as not being egg products: freeze-dried products, imitation egg products, egg substitutes, dietary foods, dried no- bake custard mixes, egg nog mixes, acidic dressings, noodles, milk and egg dip, cake mixes, French toast, sandwiches containing eggs or egg products, and balut and other similar ethnic delicacies. Products that do not fall under the definition, such as egg substitutes and cooked products, are under FDA jurisdiction.

Principal Food Safety Regulatory Organizations: FDA

Enforces food safety regulations through: - Establishment of production standards - Inspection of food production establishments and warehouses - Collection and analyses of samples for food safety hazards - Review and monitoring of animal drugs and animal feeds used in food-producing animals - Development of model codes, guidelines and interpretations and collaboration with states in implementing regulations - Requisitions and mandates to recall unsafe food - - Education and outreach to industry and consumers on safety handling practices

Verification- Environmental Monitoring

Environmental monitoring, for an environmental pathogen or for an appropri- ate indicator organism, if contamination of a RTE food with an environmental pathogen is a hazard requiring a preventive control, by collecting and testing environmental samples.

What is not an HACCP principle?

Establish a recall plan.

FDA areas of investigation:

Evaluating the safety of products via: • microbiological research • genomic research • toxicological research • chemical research To improve food safety practices in: • agricultural operations • aquaculture operations • food processing facilities • consumer perception

Internatonal governing bodies:

FAO, WHO, Codex Alimentarius, WTO

Random Inspections -> Post-market enforcement of misbranding -> =

FDA

2 gov't agencies, the U.S. Dept. of Agriculture & the FDA, share most of the responsibility of food safety inspection- EGGS=

FDA inspects shelled eggs, while USDA is responsible for egg products, liquid, frozen, & dehydrated eggs. the FDA regulates the feed chickens eat, but the laying eggs facility falls under USDA jurisdiction.

FDA Jurisdiction: eggs-

FDA is responsible for shell eggs and egg containing products that do not meet USDA's definition of "egg product." FDA also has jurisdiction in establishments not covered by USDA; e.g. restaurants, bakeries, cake mix plants, etc. Egg processing plants (egg washing, sorting, packing) are under FDA jurisdiction.

Recall power**- Food Safety Modernization Act

FDA mandatory recall authority for foods if... • there is a reasonable probability that the food is adulterated or misbranded under certain FDA authorities • the food could cause serious illnesses or death FDA must give the responsible party an opportunity to conduct a voluntary recall

Triangle pharmanaturals

FDA orders mandatory recall for kratom products due to risk of salmonella- Triangle Pharmanaturals refused to cooperate with FDA despite repeated attempts to encourage voluntary recall

Regulatory Law

FDA's FSMA Final Rule on Produce Safety (Guidance documents issued by regulatory agencies are NOT the same as the law.)

World Health Organization (WHO) "...the attainment by all peoples of the highest possible level of health."

FOOD SECURITY-- What is the difference between food security and food safety? There is no food security without food safety. Food safety has to do with the quality of the food, not the quantity. If a person cannot eat the food they have, they have no food security. Food security requires that food be safe. The quality or safety of food is or can be made a priority, and although some food may not be safe, avoiding this food will allow for food security. Our food security in a collective sense requires that all food be safe. Having enough good food is food security. Not having enough good food is a matter of not having food security. Essentially, the WTO is a place where member governments go, to try to sort out the trade problems they face with each other. The first step is to talk.

FOOD SAFETY PLAN VS. HACCP PLAN

FSMA Food Safety Plan: Hazard analysis Preventive controls • Allergen controls • Process controls • Sanitation controls • Supplier controls • Other controls Parameters, Values, and Critical limits Monitoring Corrective actions Verification Records Recall Plan HACCP Plan: Hazard analysis Process controls with CCPs to control food hazards Critical limits Monitoring Corrective actions Verification Records

1 - Follow the guidelines of FSMA

FSMA... strengthens FDA inspection and compliance authority, provides more scrutiny for imported food safety, gives FDA authority to mandate recalls, enhances partnerships in the U.S. and abroad, and focuses on preventative (instead of reactive) controls (Unruh, 2014) A subset rule in FSMA is the Mitigation Strategies Rule, or the Intentional Adulteration (IA) Rule: Primary guidelines set by FDA to address matter of food defense Final rule went into effect on May 27, 201

T/F? All food products have mandatory HACCP plans associated with them.

False!

T/F? From the case study, all of Chung's Products were exclusively regulated by the Food and Drug Administration.

False!

T/F? General adulteration provisions do not apply to dietary supplements.

False!

T/F? The FSMA Foundational Rules change the adulteration/misbranding standards of the F,D, & C Act of 1938.

False!

T/F? The international agencies (e.g., FAO) that address food issues only focus on the safety of food.

False! (FAO's mandate, written into the Preamble of the FAO Constitution, consists of 4 functions: information gathering and dissemination, formulation of policy recommendations, provision of technical assistance, and assistance to governments with FAO-related obligations. These functions serve the following goals: --Help eliminate hunger, food insecurity, and malnutrition --Make agriculture more productive and sustainable --Reduce rural poverty --Ensure inclusive and efficient agricultural and food systems --Protect livelihoods from disasters)

T/F? A substance added to food must only be safe for human consumption for approval.

False! --Before a new additive can be used in food, its producer must demonstrate the safety of the additive to FDA --Established a premarket approval process for food additives Regardless of whether the use of a substance is a food additive or is GRAS, there must be evidence that the substance is safe under the conditions of its intended use.

T/F? Dietary supplements were finally identified and classified as a unique group in the 1938 Federal Food, Drug, and Cosmetic Act.

False! (1994)

T/F? The definition of "food," according to the U.S. Code (USC), does not include food or drink for animals.

False! (Does)

T/F? The municipal water supply is regulated by the U.S. Food and Drug Administration.

False! (EPA)

T/F? A business carrying two related products is sufficient to function as a connection between the products under 'labeling'.

False! (Exception: a business carrying two related products is not sufficient to function as a connection between the products)

T/F? The amended permanent injunction against Chung's Products prohibited the firm from producing any of their products until corrective actions were taken.

False! (Same judge amended the injunction & Chung's is running as normal today)

T/F The USDA regulates a majority (>50%) of the food in the U.S.

False! (The FDA)

T/F? The net quantity of a food product is located on the information panel of the food label.

False! (The PDP)

Through a series of three Acts, Congress empowers the USDA-FSIS to inspect all meat, poultry, and processed egg products in interstate commerce for safety and correct packaging/labeling, including:

Federal Meat Inspection Act, Poultry Products Inspection Act, Eggs Products Inspection Act

Where is the Code of Federal Regulations published?

Federal Register

RETAIL PROGRAM STANDARDS- 3. Inspection Program Based on HACCP Principles

Focuses on the status of risk factors, determines and documents compliance, and targets immediate- and long-term correction of out-of-control risk factors through active managerial control Examples: • Food service establishments in at least three categories based on food safety risks • Assigns inspection frequency based on the risk categories to focus program resources

Food versus Drug

Food - taste,aroma, nutrition (& functional effects for food additives) Drug - prevents, treats, cures, mitigates or diagnosis disease

Which amendment resulted in the GRAS list within the CFR?

Food Additives Amendment

The following table summarizes the major differences between a Food Safety Plan vs. a HACCP Plan for human foods:

Food Safety Plan: Hazard Analysis Preventive Controls Parameters, Values and Critical Limits Monitoring Corrective Actions Verification Records Recall Plan HACCP Plan: Hazard Analysis CCPs Critical Limits Monitoring Corrective Actions Verification Records

What are the two U.S. federal agencies with primary responsibility for food safety in the U.S.?

Food Safety and Inspection Service (FSIS), U.S. Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC)

The importance of food defense

Food defense is important from many perspectives such as: Maintaining public health Protecting a company's brand, and Ensuring domestic and international safety/confidence. A successful bioterrorist attack on the food system could cause social panic, undermine confidence in the government, and negatively shock the economy In some ways, the food system remains vulnerable.

Is there more concern about food safety or food quality?

Food safety is a basic human right. ... As the standard of living improves, concerns over food safety and potential contaminants will continue to be an important health issue. Consumers demand quality and safety of products they consume because food as energy and nutrient is necessary to sustain life.

What was emphasized in the Pure Food and Drug Act of 1906? Weaknesses?

Food safety, Interstate trade, Foreign commerce. Major weaknesses: • Not applied within state boundaries • Difficult to enforce • Had to show intent to fraud

What is the (basic/general) difference between a food, a dietary supplement, and a drug?

Food- intended for taste, aroma, nutrition. Dietary supplement- intended to aid in supplementing a part of the diet. Not intended to replace a whole food item. Must be labeled "dietary supplement" Drug- intended to cure, mitigate, treat, or diagnose a disease.

Continuous monitoring

For each mitigation strategy, monitoring, corrective actions, and verification must occur. Monitoring establishes the frequency of procedures: Corrective actions dictate what happens if mitigation fails to occur Verification ensures that both monitoring and corrective actions occur

Under the Food Additives Amendment, two groups of ingredients were exempted from the regulation process.

GROUP I - Prior-sanctioned substances - are substances that FDA or USDA had determined safe for use in food prior to the 1958 amendment. Examples are sodium nitrite and potassium nitrite used to preserve luncheon meats. GROUP II - GRAS (generally recognized as safe) ingredients - are those that are generally recognized by experts as safe, based on their extensive history of use in food before 1958 or based on published scientific evidence. Among the several hundred GRAS substances are salt, sugar, spices, vitamins and monosodium glutamate (MSG). Manufacturers may also request that FDA review the industry's determination of GRAS Status.

Food and Agriculture Organization of the UN (FAO)

HELP ELIMINATE HUNGER, FOOD INSECURITY AND MALNUTRITION MAKE AGRICULTURE, FORESTRY AND FISHERIES MORE PRODUCTIVE AND SUSTAINABLE REDUCE RURAL POVERTY ENABLE INCLUSIVE AND EFFICIENT AGRICULTURAL AND FOOD SYSTEMS INCREASE THE RESILIENCE OF LIVELIHOODS TO THREATS AND CRISES

AUTHORITY TO DENY ENTRY

If a food producer in another country does not permit FDA to inspect its facility, FDA can refuse to allow food from that facility into the United States

How does the U.S. Food and Drug Administration conduct their scientific investigations?

In the laboratory "In the field" at various geographic locations Using computer-based computational analysis Through surveys

o Standards of identity --What is it? o Standards of quality --How good is it? o Standards of fill --Is container properly filled? o Standards of grade --What is the level of quality?

List the 4 types of food standards.

Indirect Adulteration

Listeria in ready-to-eat deli meats. (--Filth and insanitary conditions)

WTO- CODEX FAO-

Making sure food is more available to all; underdeveloped countries still getting some. (the trade is fair & just)

A food is considered misbranded/adulterated until proven safe by:

Manufacturer

Who is responsible for ensuring a dietary supplement is safe?

Manufacturer

Does net quantity have to be on information panel of food label?

No

Food safety issues include which of the following attributes of a food product?

Pathogens (-Microorganisms (Infectious, Toxins) -Allergens -Foreign Materials -Chemicals)

From our discussion with Dr. Jarrod Kersey, what is the first step in the product development and patent process?

Mapping the landscape of the specific niche to determine what has already been done

The FDA as to CBD/Marijuana

Marijuana still a schedule one drug and as such: --Cannot be considered by the FDA as a medicine --Cannot be researched and tested the way most drugs are CBD= Cannabidiol as Epidiolex has been approved --Cannabidiol is the non-psycho-active part of marijuana --Epdiolex costs $30k/yr

Major food allergens:

Milk, egg, fish (e.g., bass, flounder, or cod), Crustacean shellfish (e.g., crab, lobster, or shrimp), tree nuts (e.g., almonds, pecans, or walnuts), wheat, peanuts, and soybeans or any food ingredient derived from this list -Milk was the most prominent undeclared allergen

On what basis did the U.S. FDA have to intervene during the Elixir Sulfanilamide incident?

Misbranding- o Only basis for FDA jurisdiction was misbranding --"elixir" was reserved from drugs containing ethanol o Failure to test for safety or to list ingredients was not a violation of 1906 Act --used to treat strep infections, contained poisonous antifreeze

Based on the Trader Joe's Case Study conducted in class: On what basis did the case go to federal court?

Misleading labels about the term 'Soymilk', 'Evaporated Cane Juice', & chemical preservatives in the yogurt.

What food defense rules are companies required to adhere to protect their products?

Mitigation Strategies Rule

Are you an importer as defined under Part 1 subpart L? (see 21 CFR 1.500) That is, are you the U.S. owner or consignee of an article of food that is being offered for import into the United States? Or, if there is no U.S. owner or consignee of an article of food at the time of U.S. entry, are you the U.S. agent or representative of the foreign owner or consignee at the time of entry?

NO: FSVP doesn't apply to you YES: Subject to FSVP

Does your farm grow, harvest, pack or hold produce? Sections 112.1 and 112.3(c) We define "produce" in section 112.3(c).

NO: Your farm is NOT covered by PSR YES: Covered

What is the adaptable framework system that is activated and coordinates response participants if there are national emergencies?

National Response Framework

Incidental Adulterant

Natural adulteration, non-natural adulteration, Metallic contaminants: Toxic varieties of pulses, mushrooms, green and other vegetables, fish and sea foods Pesticide residues, tin from can, droppings of rodents, larvae in foods Arsenic from pesticides, lead from water, mercury from effluent, from chemical industries, tins from cans

Can recipes be patented?

Numerous patents on food products are issued each year. However, if you take a look at most of these patents, you'll find that the recipe was more likely to have been created in a laboratory than on a kitchen counter. A patent isn't the only way to acquire intellectual property protection for food products. Trade secrets are often used by companies to protect their recipes and processes, but they differ considerably from patent protection in a number of ways. With a trade secret, inventors do not disclose the inner workings or formula of the invention, and employees or collaborators usually sign non-disclosure agreements that prevent them from sharing the recipe. Many food companies and restaurants choose to use trade secrets to protect their recipes and methods because it allows them to use the secretive nature as a marketing tool. The recipes for Coca-Cola, Dr. Pepper, Bush's Baked Beans, and KFC fried chicken are all trade secrets, and each company has, at some point, used that secret as a part of their advertising campaigns.

Mitigation Strategies

Outside security •Property perimeter •Building perimeter •Vehicles General Inside Security •Facility/Plant •Utilities •Laboratory •Process Computer Systems Logistics and Storage Security •Suppliers and Vendors •Incoming Shipments •Outgoing Shipments •Live Animals •Returned Products/Goods •Ice/Water/Processing Aids • Storage/Warehouse • Hazardous Materials/Chemicals Management •Personnel Security •Food Defense Plan

Principal Food Safety Regulatory Organizations: FDA

Oversees 80% of our food supply, including: All domestic and imported food sold across state lines, including shell eggs, but NOT meat and poultry - Seafood, except catfish - Game meats (such as venison) - Shell eggs and egg containing products outside of the USDA-FSIS control; egg washing, sorting, and packing - Bottled water - Wine beverages with less than 7% alcohol

Principal Food Safety Regulatory Organizations: USDA-FSIS

Oversees: - Domestic and imported meat and poultry (excluding game meat) - Products such as meat- or poultry-containing stews, pizzas, and frozen foods - Processed egg products, generally liquid, frozen, and dried pasteurized egg products - Catfish

Ex. of case law?

POM Wonderful v. Coca-Cola Co. (2014)

The following is a summary of the major components of FSMA regulations regarding cGMPs:

Part 117.10 Personnel Part 117.20 Plant and grounds Part 117.35 Sanitary operations Part 117.37 Sanitary facilities and controls Part 117.40 Equipment and utilities Part 117.80 Processes and controls Part 117.93 Warehousing and distribution Part 117.95 Holding and distribution of human food by‐products for use as animal food Part 117.110 Defect action levels

WHAT CAN BE PATENTED?

Patents protect useful inventions. They must have some utilitarian value and have a functional purpose. Specifically, an invention must meet the following five requirements before it can be patented: • Patentable subject matter • Useful • Novel • Nonobvious • Enablement

Intentional Adulteration

Physical, Biological adulterant: Sand, marble chips, stones, mud, other filth, talc, chalk powder, water, mineral oil Papaya seeds in black pepper, Argemone seeds in mustard seed etc.

Will Marijuana cause changes in the FDA as we know it?

Potentially YES due to its impact on our master regulatory system The Endocannabinoid System: • Discovered in 90's • The ECS is not taught at ANY major colleges, universities, or schools of medicines • Most PhDs, physicians, and researchers are not aware of the ECS

Barriers

Probable barriers include: --This duplication of regulation adds cost and complexity. --If the national standards are the same, the duplication still arguably adds unnecessary cost and burdens trade

RETAIL PROGRAM STANDARDS- 8. Program Support and Resources

Provides funding, staff, and equipment necessary to accomplish compliance with the Voluntary National Retail Food Regulatory Program Standards

RETAIL PROGRAM STANDARDS- 4. Uniform Inspection Program

QA program to ensure uniformity among regulatory staff in the interpretation and application of laws, regulations, policies, and procedures

GRAS VS. FOOD ADDITIVE

Regardless of whether the use of a substance is a food additive or is GRAS, there must be evidence that the substance is safe under the conditions of its *intended use*.

FDA food-related products:

Regulates ~80% of the food in the U.S. -dietary supplements -bottled water -food additives -infant formulas -other food products: ex. seafood, shell eggs, produce, dairy, wild game

So what happens when you can grow your own medicine in your backyard?

Regulatory changes... Need to regulate natural products as drugs? Safety/cGMP/Consumer protections should be focus Education!

Manufacturers of dietary supplements are:

Required to ensure that the dietary supplement label info is truthful and not misleading.

What is true regarding FDA administrative detention under FSMA?

Requires only a reason to believe food is adulterated/misbranded. (Administrative detention provides a means through which FDA can hold adulterated or misbranded food and prevent it from reaching the marketplace, thus further enhancing FDA's ability to ensure the safety of food for U.S. consumers.)

For substance to be permitted by the FDA to be added to food, the substance must be:

Safe under the conditions of its intended use.

mandatory HACCP?

Seafood and Juice

Economic Adulteration

Selling vegetable oil as olive oil. (--Consumer deception; very closely related to misbranding --Born out of circumstances of the 1906 Act • Involves the selling of a product containing inferior ingredients but marketed as containing superior ingredients • 21 USC 342 (b): (1)valuable constituent omitted; (2) substance substituted --Can be applied if a standard of identity exists for a product and it is shown to be substandard • Attempts to confuse the consumer and profit from fraud --In most cases there is no risk of harm)

SUMMARY

Substances can be added to the food: • As a component of the food • Through contact with packaging material • Through contact with surfaces on processing equipment All substances added to food are considered unsafe, EXCEPT: • Prior-sanctioned • GRAS - generally available scientific evidence and long established use • Food additive - safe for the manner in which it will be used based on scientific research FDA will publish a food additive regulation if the substance & use are found to be safe.

CONSUMER PERSPECTIVE

Survey (n = 673): --2/3 would try cultured meat --1/3 would eat regularly Dutch study: The more participants learnt about cultured meat the more they were willing to support it

Intentional adulteration

Tampering with food to cause harm. (--Involves an array of acts taken with the purpose of causing harm --E.g., tampering with food in a grocery store; or introducing an adulterant in a production facility)

On what basis does the Produce Safety Rule differentiate if the produce is covered in the rule?

That it is 'rarely consumed raw' (Fruits, vegetables, sprouts, and mushrooms covered under the regulation are: -Grown on commercial farms with average annual produce sales of at least $25,000 calculated over the previous three years of production. Sales values in the regulation written in 2011 must be adjusted upward each year to account for inflation (see the calculation tool on the FDA website). -Likely to be eaten raw (e.g., leafy greens, cucumbers, tomatoes, summer squash, and most fruits). Raw produce is considered riskier than cooked fruits and vegetables where any harmful microorganisms are likely to be destroyed. Put another way, produce not covered under the regulation includes those commodities that are: -Grown on farms with average annual produce sales less than $25,000 (increased each year to account for inflation). -Rarely eaten raw (e.g., potatoes, winter squash, pumpkins, and some root crops). FDA has an exhaustive list of produce that is rarely consumed raw, and thus not covered under the regulation.)

Codex Alimentarius (Codex)

The Codex Alimentarius Commission was created in 1963- ◦ develop food standards, guidelines and related texts ◦ Science-based --The Codex Mandate: -Protect the health of consumers through the adoption of science-based food safety standards -Ensure fair practices in the food trade and foster harmonization of food standards worldwide

USDA Jurisdiction: The Egg Products Inspection Act-

The Egg Products Inspection Act defines egg to mean the shell egg of domesticated chicken, turkey, duck, goose or guinea. Voluntary grading of shell eggs is done under USDA supervision. (FDA enforces labels/labeling of shell eggs.)

From the patent assigned and discussed with Dr. Jarrod Kersey, why was the phosphate-compound coated pet food patent initially rejected?

The claim they made fell under the "drug" category

HOW LONG DOES THE PATENT LAST?

The patent term - the time you have the "limited monopoly" — depends upon the type of patent you have. Traditionally, there are three primary types of patents: utility, plant, and design. •Utility Patent Term: 20 years from date of filing •Plant Patent Term: 20 years from date of filing •Design Patent Term: 14 years from date of grant

General requirements applicable to a supply‐chain program:

The supply‐chain program must include: 1) Using approved suppliers; 2) Determining appropriate supplier verification activities (including determin- ing the frequency of conducting the activity); 3) Conducting supplier verification activities; 4) Documenting supplier verification activities; and 5) When applicable, verifying a supply‐chain‐applied control applied by an entity other than the receiving facility's supplier and documenting that veri- fication, or obtaining documentation of an appropriate verification activity from another entity, reviewing and assessing that documentation, and docu- menting the review and assessment. The following are appropriate supplier verification activities for raw materials and other ingredients: 1) Onsite audits; 2) Sampling and testing of the raw material or other ingredient; 3) Review of the supplier's relevant food safety records; and 4) Other appropriate supplier verification activities based on supplier performance & the risk associated with the raw material/other ingredient

Food definition: 21 USC § 321

The term "food" means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.

PATENTABLE SUBJECT MATTER

There are four categories of inventions that Congress has deemed "appropriate" subject matter for patent protection. These include: 1. Processes - defines an action 2. Machines - a machine is defined as a concrete thing consisting of various parts or devices - note that all mechanical devices are machines 3. Articles of manufacture - something created by taking raw or prepared materials and giving them new forms, qualities, or properties 4. Compositions of matter - a composite article consisting of two or more intermixed substances

Substances can be indirectly added to the food:

Through contact with packaging material (3 subcategories: • Health hazards (HACCP) --Physical, chemical, and microbiological hazards • Indicators of insanitation (GMPs) --Visibly objectionable contaminants and evidence of infestation • Natural or unavoidable defects --Defect Action Levels (**Different than tolerances))

What was the primary objective of food standards?

To promote uniformity across food products.

What is the primary purpose of the Federal Food, Drug, and Cosmetic Act of 1938?

To stop the movement & sale of adulterated/misbranded foods in interstate commerce.

How Are Additives Approved for Use in Foods?

Today, food and color additives are more strictly studied, regulated and monitored than at any other time in history. FDA has the primary legal responsibility for determining their safe use. To market a new food or color additive (or before using an additive already approved for one use in another manner not yet approved), a manufacturer or other sponsor must first petition FDA for its approval. These petitions must provide evidence that the substance is safe for the ways in which it will be used. As a result of recent legislation, since 1999, indirect additives have been approved via a premarket notification process requiring the same data as was previously required by petition. When evaluating the safety of a substance and whether it should be approved, FDA considers: 1) the composition and properties of the substance, 2) the amount that would typically be consumed, 3) immediate and long-term health effects, and 4) various safety factors.

T/F? A food manufacturer that would like to export its product must comply with both domestic and foreign laws.

True!

T/F? Claims made about food products are regulated.

True!

T/F? Federal Trade Commission oversees advertising on food packaging.

True!

T/F? Final regulations are published annually in the code of federal regulations.

True!

T/F? Prior to the enactment of the Food Safety Modernization Act, the U.S. Food and Drug Administration could only rely on manufacturers to voluntarily recall certain potentially harmful food products.

True!

T/F? The F, D, & C Act of 1938 can be found in Title 21 of the U.S. Code

True!

T/F? The F, D, & C Act of 1938 repealed and replaced the Pure Food and Drug Act of 1906.

True!

T/F? The FSMA doesn't apply to the inspection of meat, pork, and poultry.

True!

T/F? The Federal Meat Inspection Act of 1906 did not include poultry inspections.

True!

T/F? The Food Safety Modernization Act (FSMA) gives the U.S. FDA mandatory recall authority for the first time.

True!

T/F? The Pure Food and Drug Act of 1906 and the Federal Meat Inspection Act of 1906 were signed on the same day.

True!

T/F? There is not an authoritative list of 'dietary ingredients' that were marketed before October 15, 1994.

True!

T/F? USDA pre-approves food product labels prior to the food entering interstate commerce.

True!

Based on our discussion with Dr. Jarrod Kersey, what are the qualifications of the phrase "proven" for labeling claims?

Two clinical studies showing intended effects

Case Law

U.S. v. 7 Barrels of Dried Eggs

Continuous compulsory inspections -> Pre-approval for all labeling -> =

USDA/FSIS

who does what- generally*:

USDA: • GMO labeling for all products • Organic standards for all products • Grading standards FDA: • Drugs for animals Ex. The FDA oversees shell-eggs, but the marketing branch of the USDA provides the grade (e.g., AA) on the package which is based on quality.

What is the basis for most recalls in the modern day?

Undeclared allergens

When is a standard mandatory?

Under FD&C, standards of identity, fill, quality and grade are mandatory for any product in interstate commerce

Which type of food service establishment located in Arkansas does not need to procure a food establishment permit?

Vending machines

Trader Joe's v. Gibson et. al

Warning letter: we have several additional comments regarding your labeling. your LIFESOY Natural Soymilk Unsweetened (1/2 gallon) & LIFESOY Natural Soymilk Sweetened (1/2 gallon) products use the term "milk" as part of their common/usual name. milk is a standardized food defined as the lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows. therefore, we don't consider "soy milk" to be an appropriate common/usual name because it doesn't contain "milk". we don't consider "soy drink" or "soy beverage", however, as acceptable common/usual names for such products

Objectives of HACCP

Who carries this responsibility? the HACCP team -Make the product as safe as possible -Be able to prove that product was processed safely

Do you only import these foods? (see 21 CFR 1.501) • Fish and Fishery Products (in compliance with part 123), or certain ingredients for use in fish and fishery products in compliance with part 123 • Juice (in compliance with part 120), or certain ingredients for use in juice products in compliance with part 123 • Food for research or evaluation • Certain alcoholic beverages, or certain ingredients for use in alcoholic beverages • Certain meat, poultry, and egg products regulated by USDA • Food imported for personal consumption • Food that is transshipped • Food that is imported for processing and export • U.S. food that is exported and returned without further manufacturing/ processing in a foreign country

YES: FSVP doesn't apply to you NO: Subject to FSVP

Do you import certain food from a country with an officially recognized or equivalent food safety system? (see 21 CFR 1.513)

YES: Subject to modified FSVP requirements for food from those countries-- Includes determining that the supplier is in compliance with U.S. safety regulations or relevant laws in country deemed equivalent. NO: Subject to FSVP

Do you import dietary supplements subject to certain dietary supplement current good manufacturing practice requirements in 21 CFR part 111? ( 0 21 CFR 1.511)

YES: Subject to modified FSVP requirements- for those dietary supplements subject to separate, pre-existing Current Good Manufacturing Practices (CGMPs) requirements for dietary supplements. NO: Subject to FSVP

Is your produce for personal/on-farm consumption? Section 112.2(a)(2)

YES: This produce is NOT covered by PSR NO: Covered

Is your produce intended for commercial processing that adequately reduces pathogens (for example, commercial processing with a "kill step")? Section 112.2(b)

YES: This produce is eligible for exemption from the rule, provided you make certain statements in documents accompanying the produce, obtain certain written assurances, and keep certain documentation, as per Sections 112.2(b)(2) through (b)(6). NO: Covered

Is your produce one of the commodities that FDA has identified as rarely consumed raw? Section 112.2(a)(1) If you grow, harvest, pack or hold more than one produce commodity, you must ask this question separately for each one to determine whether that particular produce commodity is covered by this rule.

YES: This product is NOT covered by PSR NO: Covered

Are you a receiving facility in compliance with requirements in the Preventive Controls for Human Food or Preventive Controls for Animal food rules related to implementation of preventive controls for the hazards in the food or supply-chain programs, or are you not required to implement a preventive control under those rules in certain specified circumstances? (see 21 CFR 1.502(c))

YES: You are deemed in compliance with most aspects of FSVP, except the requirement for importer identification at entry. NO: Subject to FSVP

Do you import food from certain small suppliers (i.e., qualified facilities under PCHF or PCAF, certain farms that are not covered farms under the produce safety regulation, and certain small egg producers)? (See 21 CFR 1.512)

YES: You are subject to modified FSVP requirements for food from those suppliers. NO: Subject to FSVP

Do you import low acid canned food in compliance with 21 CFR part 113? (see 21 CFR 1.502(b))

YES: You do not need an FSVP with respect to microbiological hazards for that food. Instead, you must verify and document that the food was produced in accordance with 21 CFR part 113. With respect to all matters that are not controlled by part 113, you must have an FSVP. NO: Subject to FSVP

Does your farm on average (in the previous three years) have $25k or less in annual produce sales? Section 112.4(a)

YES: Your farm is NOT covered by PSR NO: Covered

Does your farm on average (in the previous three years) as per Section 112.5: have < $500k annual food sales, AND a majority of the food (by value) sold directly to "qualified end-users"? Section 112.3(c) "Qualified End-User" as defined in Section 112.3(c) means: • the consumer of the food OR • a restaurant or retail food establishment that is located— (i) in the same State or the same Indian reservation as the farm that produced the food; OR (ii) not more than 275 miles from such farm. (The term "consumer" does not include a business.)

YES: Your farm is eligible for a qualified exemption from this rule, which means that you must comply with certain modified requirements and keep certain documentation, as per Sections 112.6 and 112.7. NO: Covered

Are you a very small importer? (see 21 CFR 1.500 and 1.512) For human food, an importer averaging less than $1 million per year during the 3-year period preceding the applicable calendar year, in sales of human food combined with the U.S. market value of human food imported, manufactured, processed, packed, or held without sale (e.g., imported for a fee). For animal food, an importer averaging less than $2.5 million per year during the 3-year period preceding the applicable calendar year, in sales of animal food, combined with the U.S. market value of animal food imported, manufactured, processed, packed, or held without sale (e.g., imported for a fee).

YES: you are subject to modified FSVP requirements. An example of modified requirements for certain importers M is that they would not have to conduct hazard analyses and would be able to verify their foreign suppliers by obtaining written assurances of compliance. NO: Subject to FSVP

Which ingredients can be used when making a dietary supplement?

an herb or other botanical, a mineral, & an amino acid.

Any substance that is reasonably expected to become a component of food is a food additive

and is subject to premarket approval by the FDA, unless the substance is "GRASed" by experts qualified by scientific training and experience to evaluate its safety under the conditions of its intended use or meets one of the other exclusions from the food additive definition in section 201(s) of the Federal FDCA (FFDCA).

Congress defines dietary supplements as

as food and thus they are not regulated as a drug

how is this work conducted?

at the "laboratory bench", using computer assisted computational analyses, "in the field" at various geographic locations, through surveys

To perform a hazard analysis for the development of a HACCP plan, food processors must gain a working knowledge of potential hazards. The HACCP plan is designed to control all reasonably likely food-safety hazards. Such hazards are categorized into three classes:

biological, chemical and physical. Hazard: a biological, chemical or physical agent that is reasonably likely to cause illness or injury in the absence of its control.

What would qualify a food to be classified as adulterated? (What wouldn't?):

o Contains any poisonous or deleterious substance which may render it injurious to users, when used as directed o Contains any "filthy, putrid, or decomposed substances" o Prepared, packaged, or held under unsanitary conditions and became contaminated or render injurious o Has a poisonous or deleterious container o Contains an unapproved food or color additive (Contains added substance that exceeds tolerances, Contains an unapproved food additive, Has been prepared/packed/or held under insanitary conditions) What wouldn't: Is found to contain insect parts in quantities below the defect action level

Circumstances of misbranding? (What is, what isn't):

o If label is "false or misleading" o Is an imitation of another food (unless clearly labeled as an imitation- must say "imitation") --"pasteurized prepared cheese product" is not "cheese" o Does not meet FDA regulations regarding standard of identity, quantity or fill It isn't: If the primary display panel depicts an ingredient present in the food when it's only the flavor of the ingredient that's present (bc can be labeled as imitation on other labels)

F,D,&C Provisions:

o Providing that safe tolerances be set for unavoidable poisonous substances o Authorizing standards of identity, quality, and fill-of- container for foods o Authorizing factory inspections o Adding the remedy of court injunctions to the previous penalties of seizures and prosecutions o Prohibited false statements about the food item --Addressed labeling of imitation food --Mandated affirmative labeling (product name, quantity, contents, manufacturer) --Required additional label info for dietary food

The Dietary Supplement Health and Education Act of 1994

places dietary supplements in a special category under the general umbrella of "foods," not drugs, and requires that every supplement be labeled a dietary supplement.

What does the Delaney clause require?

precludes the FDA from approving any additive that may be found to induce cancer in humans or experimental animals (banning of an added substance to food found to induce cancer in humans/animals)

HACCP places the responsibility and authority

responsibility and authority for devising an appropriate, individualized safety plan for each food on the manufacturer, rather than on a "broad-brush" government program. • HACCP is a planning, implementing and verifying procedure the food business must follow

Federal responsibility for the regulation of food safety in the U.S. primarily falls under the FDA and the USDA-FSIS. However, a number of other agencies,

such as the Centers for Disease Control (CDC) and the Environmental Protection Agency (EPA), to name a few, are involved with the safety of our food supply.

For serious FD&C Act violations,

the FDA, in coordination with DOJ, has a wide range of civil and criminal remedies.

FDA States 'Evaporated Cane Juice' Label is Misleading

the U.S. FDA issued final guidance to the food industry & declared it considers use of the term "evaporated cane juice" as an ingredient on food labels to be "false & misleading" under federal law. the term 'evaporated cane juice' is false/misleading because it suggests that the sweetener is 'juice' or is made from 'juice' & doesn't reveal that its basic nature & characterizing properties are those of a sugar, the FDA declares

The FD&C Act is chiefly enforced by:

the U.S. Food and Drug Administration (FDA), an agency whose general mission is to promote and protect the public health by ensuring the safety, efficacy, and truthful labeling of the products it regulates. FDA enforces the Act through administrative mechanisms, such as pre-market reviews of certain products, examinations and investigations, and dissemination of information to the public.

HACCP regulatory agencies

the federal regulatory agencies & the guidelines they use to protect our food supply. Hazard Analysis and Critical Control Points (HACCP) is a systematic approach to protect the food supply. the FDA & USDA require mandatory HACCP programs for juice & seafood as well as meat as an effective approach to food safety & protecting public health

The FD&C Act is the main federal law regulating the safety of:

the safety of most foods, food additives, color additives, dietary supplements, prescription and non-prescription drugs, medical devices, cosmetics, and tobacco products. While the Act regulates a host of disparate products, it generally prohibits two basic acts: "adulteration" and "misbranding." Specifically, FD&C Act Section 301 makes it illegal to distribute directly or indirectly a covered product in interstate commerce that is adulterated or misbranded.

The Food, Drug, and Cosmetic Act (FD&C Act) of 1938 tightened:

tightened controls over food and drugs, and enhanced the government's ability to enforce the law. This law, as amended, is still in force today. It's been amended over 100 times! The latest amendment, known as the Food Safety Modernization Act is the most significant amendment of U.S. food law in history.

Date labeling-* (key things to remember for test)

usually linked to quality not safety of product. What if did remove date labeling? probably an immense amount of LESS waste/disposal of perfectly qualified/ok to eat foods. FDA doesn't have mandated date labeling (Use By/Freeze By); USDA does- meat products- are in charge of their own labeling. (separate entities) -Dairy products most often discarded, prior to being quality-wise bad.

ETHICAL ASPECTS

• "moral duty" or "moral obligation" to pursue cultured meat • Vegetarianism may be a superior moral response • "... due to its expense could result in a non-meat eating elite who operate guilt free at the expense of the less well-off" • "looking to biotechnology to solve ethical crises is fraught with danger and should be avoided" • "cultured meat is a dangerous example of the decontextualization and molecularization of sustainability"

FOOD SAFETY: A. C. A. § 20-57-104

• (a)Employees of food service establishments shall keep their hands and exposed portions of their arms clean in a manner approved by the Department of Health. • (b) (1) Except when washing fruits and vegetables, employees of food service establishments shall avoid contact of exposed ready-to-eat food with their hands by use of suitable utensils such as deli tissue, spatulas, tongs, or single-use gloves, or they shall wash their hands and exposed portions of their arms utilizing a hand-washing program approved by the department. • (b) (2) Employees shall minimize bare-hand and bare-arm contact with exposed food that is not in a ready-to-eat form.

FSVP

• "Foreign Supplier Verification Programs for Importers of Food for Humans and Animals" • Provides reciprocal requirements to imported food as those applied to domestically processed food (PCHF and PCFA) • Imported food should be as safe as domestic food • Requirements of an *importer*

PSR - STANDARDS FOR PRODUCE SAFETY

• "Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption" • Establishes, for the first time, science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption • Based on a foundation of Good Agricultural Practices (GAPs)

PCFA

• "cGMP, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals" • Effectively a twin to the PCHF Final Rule • Structure is identical to the PCHF Final Rule • First time GMPs will apply to animal feeds • *Notable differences with PCHF: • Omission of allergens as hazards • Inclusion of nutrient imbalances*

PCHF

• "cGMP, Hazard Analysis, and Risk-Based Preventive Controls for Human Food" • Prior to FSMA... • cGMPs were the only requirements to ensure food was manufactured, processed, packaged, and stored in sanitary conditions to avoid adulteration • HACCP was voluntary for most food companies • Now... • Modernized GMPs • Adopted a proactive, "HACCP-like" system where potential hazards are identified and controlled • Requires a written Food Safety Plan for all covered facilities

CELL-CULTURED MEAT: WHERE ARE WE NOW?

• 2013 to the present, numerous companies founded for the development of cellular animal agriculture products • Regulatory implications have been speculated and might be primarily based on the techniques used in production • Labeling • Food fraud • Regulatory oversight

Dietary supplement- means a product that:

• 21U.S.C.§321(ff) 2) Means a product that -- A. i) is intended for ingestion in tablet, capsule, powder, softgel, gelcap, or liquid form; or ii) is not intended for ingestion in such a form, is not represented as conventional food and is not represented for use as a sole item of a meal or of the diet B. Is not represented for use as a conventional food or as a sole item of a meal or the diet; and C. Is labeled as a dietary supplement

What are the 3 criteria for the FDA use for establishing a tolerance for an added substance?

• 3 criteria 21 USC § 346(b): • Cannot be avoided/controlled by GMPs • Established tolerance is sufficient to protect public health (cumulative exposure) • No technological or other changes are foreseeable in the near future that affect the appropriateness of the tolerance established

Waste at Restaurants

• 4-10% of inventory gets wasted before serving • 17% of meals are left uneaten by diners • 55% of edible leftovers are left behind

WHAT IS THE DEFINITION OF MEAT?

• 7 CFR §54.1 • The edible part of the muscle of an animal, which is skeletal, or which is found in the tongue, in the diaphragm, in the heart, or in the esophagus, and which is intended for human food, with or without the accompanying and overlying fat and the portions of bone, skin, sinew, nerve, and blood vessels which normally accompany the muscle tissue and which are not separated from it in the process of dressing.This term does not include the muscle found in the lips, snout, or ears.

Understanding Food Product Dating

• A Sell by date indicates that a product should not be sold after that date if the buyer is to have it at its best quality. • A Use by or Best by date is the maker's estimate of how long a product will keep at its best quality. They are quality dates only, not safety dates. If stored properly, a food product should be safe, wholesome and of good quality after its Use by or Best by date. • Purchase the product before "sell-by" or expiration dates. • Follow handling recommendations on product. • Keep meat and poultry in its package until just before using. • If freezing meat and poultry in its original package longer than 2 months, overwrap these packages with airtight heavy-duty foil, plastic wrap, or freezer paper; or place the package inside a plastic bag. Because freezing 0° F (-18° C) keeps food safe indefinitely, the following recommended storage times are for quality only.

Recall power**- How does the FDA know there needs to be a recall?

• A company discovers a problem and contacts FDA • FDA inspects a manufacturing facility and determines the potential for a recall • FDA receives reports of health problems through various reporting systems • The Centers for Disease Control and Prevention (CDC) contacts FDA

Foodborne illness is a significant burden:

• About 48 million (1 in 6 Americans) get sick each year • 128, 000 are hospitalized • 3, 000 die

Advertisement panel/Product claims

• Advertisement panel --Remainder of package may include instructions/directions, UPC label, warnings, quality guarantee statements, etc. --still cannot be misleading even if outside of PDP/info panel • Product claims --claims about food products are regulated --must abide by FDA regulation --if food business claim is not regulated, the claim can be made as long as not misleading

ACCREDITED THIRD-PARTY CERTIFICATION

• Amended the FD&C Act to add Section 808 • Establishes a framework, procedures, and requirements for a program to certify third-party auditors • 21 CFR Part 1, Subpart M • Two FSMA specific uses for certifications under this program: 1. May be used by importers to help establish eligibility for participation in the Voluntary Qualified Importer Program, which offers expedited review entry of food 2. In specific circumstances, FDA can require that a food offered for import be accompanied by a certification from an accredited third-party certification body

FSVP - WHO IS AN IMPORTER?

• An importer is the U.S. owner or consignee of a food offered for import into the U.S. Importer: person who purchased the food being imported. No U.S. Owner?: then the importer is the consignee. No Owner or Consignee?: then the importer is the U.S. Agent When in doubt: who has the financial interest and control over the supply chain?

FDA FOOD CODE

• Based on input from the Conference for Food Protection • FDA recommends adoption by each state, it CANNOT require it • 4-year interval between complete Food Code editions. --During the interim, FDA may publish supplements to the Food Code that update, modify, or clarify certain provisions • The 2017 Food Code is the most recent full edition published by the FDA

SANITARY TRANSPORT OF FOOD

• Builds on the Sanitary Food Transportation Act of 2005 • *Goal is to prevent practices during transportation that create food safety risks* (E.g., failure to properly refrigerate food, inadequate cleaning of vehicles between loads, failure to properly protect food) • Establishes requirements for shippers, loaders, carriers by motor or rail vehicle, and receivers involved in transporting human and animal food to use sanitary practices • **Does NOT apply to transportation by ship or air • Does NOT apply to exporters who ship food through the U.S.**

RECAP

• Businesses are prohibited from selling food *if the food is adulterated/misbranded, or the firm has otherwise committed a "prohibited" act.* --U.S. federal law applies only to food that is in *"interstate commerce"* --Food that has been modified/altered is considered adulterated unless there's regulation allowing the modification/alteration/addition • A food business can petition the FDA to issue a regulation that would allow for a specific modification that the business wants to use in its food processing, but the petition needs to be supported with evidence that the requested process does not render the food unsafe.

FSMA

• Signed into law Jan. 4, 2011 Amended the FD&C Act in 3 principal ways: • New enforcement powers and lower threshold for administrative actions for FDA • Requires the FDA to promulgate seven foundational rules • Integrates the supply chain by requiring supplier verification --*In no way impacts the inspection of meat, pork, or poultry by the USDA-FSIS*

RE TAIL AND FOOD SERVICE

• State License and Inspection • FDA Food Code

ADULTERATED FOOD: 21 USC §342

• Consists in whole or in part of any filthy, putrid, or decomposed substance, or if it otherwise unfit for food • Has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health • Is, in whole or in part, the product of a disease animal or of an animal that has died other than by slaughter • Has been intentionally subjected to radiation (*unless conforms with regs) • Any valuable constituent has been in whole or in part omitted, substituted, damage concealed, or substance added to increased bulk or weight (*economic adulteration) • Has additives, microbes, and conditions that could lead to contamination (FOOD IS CONSIDERED TO BE ADULTERATED OR MISBRANDED UNLESS THE FOOD BUSINESS CAN ESTABLISH THAT THE FOOD MEETS THE APPLICABLE LEGAL REQUIREMENTS**)

Food Waste by Consumers

• Consumer food waste has increased 50% per capita since 1974 • Average: 20lbs of food wasted/month; about $28-43 per month lost • Over-serving estimated to be 33%; "Goes bad" at 67%

FSVP AND DIETARY SUPPLEMENTS

• Does not apply to an importer of dietary ingredients and other components • Preexisting cGMPs for dietary supplements apply • Does apply to an importer of "finished" dietary supplements

Basis- FOUNDATIONAL RULES

• Does not change the adulteration or misbranding standards in Section 342 of FD&CAct • Establishes new, prevention-oriented standards that are science and risk-based, across the supply chain • **Goal = proactively stop or mitigate adulteration and wide-scale foodborne illness outbreaks** • Increase the regulatory burden on food companies to take appropriate measure to prevent food contamination and document their compliance

STATE LICENSE AND INSPECTION

• Each state has their own laws and regulations • Retail food establishments/restaurants do not have to be registered with the federal government (21 CFR §1.226) Definitions: • Restaurant - a facility that prepares and sells food directly to consumers for immediate consumption • Retail food establishment - an establishment that sells food products directly to consumers as its primary function

FSVP PLAN- risk

• Evaluation of the risk posed by the imported food and the supplier's performance must be reevaluated: • At least every 3 years; or • When new information comes to light about a potential hazard or the foreign supplier's performance

TECHNIQUES

• Expanding stem cells then differentiating them into muscle cells • Chemical/biological cues and mechanical stimulation --Two approaches: • Scaffold-based: use of embryonic myoblasts or adult skeletal muscle satellite cells; suitable for processed meats but not highly structure meats • Self-organizing: proliferating existing muscle tissue (explants); contain all of the cells that make up muscle in their corresponding proportions

FOOD CODE

• FDA has little authority to regulate the retail sector of the food industry • State and local governments bear responsibility • FDA offers suggestions to state and local governments to consider in order to develop their regulatory oversight • These suggestions are contained in the FDA Food Code --FDA also offers scientifically-based guidance, training, program evaluation, and technical assistance

FSVP - REQUIREMENTS

• FSVP Plan is an analysis and written procedures to ensure the only food imported is safe based on an evaluation of risk and the supplier's performance • Determine known or reasonably foreseeable hazards with each food • Evaluate the risk posed by a food, based on the hazard analysis, and the foreign supplIer's performance • Determine appropriate supplied verification activities • Conduct supplier verification activities • Conduct corrective actions • FSVP Plan must be developed for *each imported food*

AR EXEMPTIONS cont.

• Farmers' market, farm market, or festival/celebration (≤7 days) offering for sale: • RACs • Maple syrup, sorghum, or honey produced by a maple syrup or sorghum producer/beekeeper • Commercially packaged food that is not potentially hazardous • An establishment that offers only prepackaged foods that are not potentially hazardous as defined by the State Board of Health • Ice vending machines or kiosks where ice is dispensed in the open air and that are totally self-contained

RETAIL PROGRAM STANDARDS- 2. Trained Regulatory Staff

• Food Safety Inspection Officers (FSIO) shall have the knowledge, skills, and ability to adequately perform required duties • 5-step training and standardization • 90% of FSIO need to complete

The definition of "transportation operations" excludes:

• Food completely enclosed by a container (except that require refrigeration) • All transportation activities performed by a farm • Transport of human food byproducts for use as animal food without further processing, i.e., those sold directly to farmers to be fed to livestock • Imported food for future export • Food contact substances • Live food animals except molluscan shellfish

Food waste in the U.S. is a significant contributor of greenhouse gases

• Food waste makes up1 4.5% of all Municipal Solid Waste • Food waste contributes "8% of total global greenhouse gas emissions. If food waste were a country, it would come in third after the US and China in terms of impact on global warming." Wash. Post, The climate impact of the food in the back of your fridge (July 31, 2018)

FSVP - EXEMPTIONS

• Full exemptions include food that is • Transshipped - only using a U.S. port to pass through • Food for personal consumption • Alcoholic beverages and certain ingredients for use in

RETAIL PROGRAM STANDARDS SHOULD...

• Identify program areas where an agency can have the greatest impact on retail food safety • Promote wider application of effective risk-factor intervention strategies • Assist in identifying program areas most in need of additional attention • Provide information needed to justify maintenance or increase in program budgets • Lead to innovations in program implementation and administration • Improve industry and consumer confidence in food protection programs by enhancing uniformity within and between regulatory agencies

RETAIL PROGRAM STANDARDS- 1. Regulatory Foundation

• Includes any statue, regulation, rule, ordinance, or other prevailing set of regulatory requirements that governs the operation of a retail food establishment --Requirements: • Food Code Interventions and Risk Factor Control Measures • Good Retail Practices • Compliance and Enforcement

FSVP - NOT COVERED

• Juice, fish, and fishery products subject to and in compliance with FDA's HACCP regulations for those products and certain ingredients for use in juice and fishery products • Food for research or evaluation • Low-acid canned foods (LACF), such as canned vegetables, but only with respect to microbiological hazards covered by other regulations, as well as certain ingredients used in LACF products *FSVP DOES NOT apply to an importer of dietary ingredients and other components (Preexisting cGMPs for dietary supplements apply)* *FSVP DOES apply to finished dietary supplements*

SAFETY CONCERNS?

• Labeling --State laws versus federal --Allergen labeling • Food fraud --Can we confirm the cell cultured meat is from the animal it says?

CELLULAR ANIMAL AGRICULTURE PRODUCTS

• Milk from bioengineered yeast and plant- based fats (Perfect Day Foods) • Cheese from aforementioned bioengineered milk (Real Vegan Cheese) • Yeast reprogrammed to produce egg white proteins (Clara Foods) • Cultured bluefin tuna (Finless Foods)

Packaging and Adulteration- indirect food additives:

• Most recently referred to as 'Food Contact Substances' • Defined as materials that come into contact with food as part of the packaging, holding, or processing • Not intended to be added directly to, become a component, or have a technical effect in or on the food

PCHF - FOOD SAFETY PLAN

• Must contain 6 components: 1. A hazard analysis "known or reasonably foreseeable" 2. Preventive controls 3. A risk-based supply chain program, if appropriate 4. A recall plan, if there are any hazards associated with the food 5. Procedures for monitoring the implementation of the preventive controls 6. Procedures for verifying that the preventive controls are consistently implemented and are effectively minimizing or preventing the identified hazards

Types of claims

• Nutrient content -highlights a key nutrient • Structure-function - links the role of nutrient to normal physiological function in the body • Health - indicates link to prevention of disease • Superiority - shows superiority in some form or fashion to competitor • Comparative - claims that neutralize impact of competitive claim • Performance - informs the consumer the product will do something for the pet • Implied - the implied claim is key "take away" by the consumer

NON- ADDED SUBSTANCES

• Ordinarily injurious standard • Does the naturally occurring substance render the food injurious when consumed by ordinary consumers in ordinary quantities? *(ordinarily injurious, naturally occurring in product, at certain level) higher threshold*

Waste at Retail Markets

• Over 40 Billion lbs. of food are wasted in U.S. retail stores annually • Supermarkets are estimated to lose $15 billion per year in unsold fruits and vegetables

State Codes - e.g., "Arkansas Code Annotated"

• Permit required - A.C.A. § 20-57-204 • No food service establishment shall be allowed to operate unless it has procured a food establishment permit --AR definition: • Food service establishment - means any place where food is prepared, processed, stored, or intended for use or consumption by the public regardless of whether there is a charge for the food.

FDA FOOD CODE- Notable changes:

• Person in Charge must be a Certified Food Protection Manager • Use of bandages, finger cots, or finger stalls require covering with single-use glove • Must have written procedures for clean-up of vomiting and diarrheal events • Separate raw animal food from fruits and vegetables before they are washed or redesignated • Cooking times and temperatures harmonized with USDA FSIS • Cleaning and sanitizing agents used for equipment and utensils should be provided and available for use during all hours of operation

***7 FOUNDATIONAL RULES****: OVERVIEW

• Preventive Controls for Food for Animals(PCFA) • Preventive Controls for Human Food(PCHF) • Standards for Produce Safety(PSR) • Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (FSVP) • Accredited Third-Party Certification • Sanitary Transportation of Human and Animal Food • Mitigation Strategies to Protect Food Against Intentional Adulteration

MANDATORY RECALL

• Prior to FSMA, FDA would need a court order to compel a recall if a food firm was reluctant to conduct a recall • Section 206 • Provided FDA authority to order a recall under certain circumstances *after first giving the firm the opportunity to initiate a voluntary recall*

SUSPENSION OF A FOOD FACILI T Y LICENSE

• Prior to FSMA, there was no ability to suspend a facility's registration under any circumstances • A registration effectively allows a facility to sell while also allowing the FDA to monitor what facilities to inspect • Section102 • Granted FDA new authority to suspend a facility's registration when there is a *"reasonable probability"* of causing serious health problems or death • Practical effect is to stop the facility's operations

USDA recall power:***

• Recalls are initiated by the manufacturer or distributor of the meat or poultry, sometimes at the request of FSIS • All recalls are voluntary • However, if a company refuses to recall its products, then FSIS has the legal authority to detain and seize those products in commerce

PSR- EXEMPT PRODUCE

• Receives commercial processing that adequately reduces the presence of microorganisms of public health significance (Example: processing of tomato paste or shelf stable tomatoes) --MUST...: • Disclose in documents accompanying the produce, that the food is "not processed to adequately reduce the presence of microorganisms of public health significance"; AND • Obtained assurance that the customer is performing commercial processing.

requirements- PCHF - FOOD SAFETY PLAN

• Requires reanalysis a minimum of every 3 years • 4 conditions may require reanalysis sooner: 1. Significant change in activities conducted at the facility creates a reasonably potential for a new hazard or creates a significant increase in a previously identified hazard 2. Become aware of new information about potential hazards associated with the food 3. Whenever appropriate after an unanticipated food safety problem 4. Determine that a preventive control, combination of preventive controls, or the food safety plan as a whole is ineffective

REGULATORY PATHWAYS

• Schneider (2013) considered regulations in the U.S. • 'Substantial equivalence' regulatory model is inappropriate --Pathway depends on technique used: 1. Explant systems - FDA New Animal Drugs Application 2. Scaffold-based - FDA food additive provisions • Key concern is safety

AR EXEMPTIONS

• Supply vehicles or locations of vending machines • Group homes and day care centers serving ten or fewer persons • Potluck suppers, community picnics, or other group gatherings where is served but not sold • Roadside stand with RACs (raw agricultural commodities) • A cottage food operation, on the condition the operation offers its products directly to the consumer

REGULATORY COMPONENTS OF A LABEL

• Two chief packaging areas are defined: • Principal display panel (PDP), or 'face of the package' • Facing out from shelf or on the top of the packaging • 21 CFR Part 101 - "that portion of the package label that is most likely to be seen by the consumer at the time of purchase" • Must contain: Name of food (statement of identity) and the Net quantity • Information panel - Immediately to the right of the PDP • Refers to the label statements that are generally required to be placed together, without any 'intervening material' 1. Nutrition labeling 2. Statement of ingredients (including allergens) 3. Name and address of manufacturer, packer, or distributor • The central statutory prohibition for all labeling is against misleading labels

FSVP - MODIFIED

• Very small importers and importers of food from certain small suppliers. • Certain foods from a foreign supplier in a country whose food safety system has been recognized as comparable or determined to be the equivalent of the U.S. system

WHAT IS THE DEFINITION OF CULTURED MEAT?

• Widely contested, ambiguous, and political • What has been proposed? • Hocquette (2016) argues cultured meat is most accurately described as "artificial muscle proteins" because 'meat' implies maturation inside an animal and the process of slaughter • An ingredient that a meat producer to work into a final meat product • Not fit for consideration as food at all --Alternative names: • In vitro meat • Clean meat • Derogatory terms: lab meat, synthetic meat, Frankenstein meat

The final rule implements the requirements of FSMA for covered facilities to establish and implement a food safety system that includes sound sanitation programs, a hazard analysis, and risk‐based preventive controls. Specifically, the rule establishes requirements for:

● A written food safety plan; ● Hazard analysis; ● Preventive controls; ● Monitoring; ● Corrective actions and corrections; ● Verification; ● Supply‐chain program; ● Recall plan; and ● Associated records.

Environmental Monitoring Procedures

● Identify test microorganism ● Identify locations (may be guided by zoning*) and number of sites to be tested ● Identify timing and frequency for collecting and testing samples ● Identify test, including the analytical method ● Identify the laboratory conducting testing ● Include corrective action procedures

The CFR is published in the Federal Register:

◦ Published by the executive departments and agencies of the Federal Government ◦ Federal Register is the official daily publication for rules, proposed rules, and notices of Federal agencies and organizations