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Overview of Food Law
The purpose these materials is to provide an overview of laws that impact the food industry. However, the topic is much more complex than that simple statement may imply. As the food industry has grown more complex, so have the laws that direct the industry.
- The focus of this discussion is upon US federal law, but the role of state law and international standards also are introduced.
- The discussion focuses on the processing sector of the food industry, but the agricultural production, food retail, food preparation sectors also are briefly addressed.
- Assuring the safety of food is emphasized, but the importance of nutrition also is mentioned.
These materials begin with an ____. Subsequent topics include ____.
Concerns about Food
Everyone needs, and probably wants, assurance that the food we consume 1) has not spoiled nor that it contains micro-organisms or foreign substances that will make us sick, and 2) will meet our nutritional needs of calories, vitamins, minerals, protein, fat, carbohydrates, and other requirements. Restated, our concern is that the food we consume has been produced, processed, packaged, stored, and prepared in such ways as to protect its integrity, that it remains safe for us to consume, and that it will meet our nutritional needs.
Over the past 150 years, people have come to rely much more on others to produce, process, package, store and prepare our foods (in 2002, only 54% of our food expenditures were for at-home consumption; USDA ERS at http://www.ers.usda.gov/AmberWaves/April04/Indicators/). Also, the producers, processors, retailers, and preparers are commingling much larger quantities of food (e.g., hundreds of pounds of beef in a single vat and thus a pound of hamburger may come from many different animals), commingling more ingredients (e.g., preparing a ready-to-eat food may include grain, meat, eggs and dairy products), and adding more substances (seasoning, vitamins, and preservatives). It is no longer a situation where each family produces, perserves and prepares their own food. Thus we know less about what we consume than our ancestors who had to raise, hunt or gather their own food. We are also in a situation where one food-borne illness can inflict many people in dispersed areas. Thus a serious food safety concern can have significant implications for our nation and international society.
A reaction is that this shift in the past 150 years has not been an improvement. That is, we sometimes assume that knowing how we produced, preserved and prepared our food will stop us from eating food that we know or suspect may not be safe, and that we had that knowledge when we provided our own food. But we also know that many people became ill from eating their own food, so that method was not fool-proof either.
This shift to not producing and preparing our own food reflects industrialization and the resulting urbanization. This shift also reflects the associated mechanization of the ag and food industry (which is not unrelated to the industrialization of other industries).
One of the difficulties is the inability for today's consumers to sense the quality of food they are buying. Yes, we can smell and see food and with experience recognize whether it is spoiled; but we cannot necessary see or smell whether the food is nutritious, whether it contains something that will make us sick, or contain something that will cause some individuals to have an allergic reaction. Also, as food is packaged, we may no longer be able to see, smell or feel it before we buy it (such as a can of vegetables). Thus an alternative method had to be devised that replaces knowing how our food was produced and prepared.
Society stepped in through our governments. States moved first; federal government came along a little slower and a little later; but once the federal government stepped in, it pre-empted state regulation (not uncommon legal outcome and something recognized more than 230 years ago when US governmental structure was devised; that is, federal law preempts state law, even though I doubt the drafters of the Constitution envisioned the world we live in today). At this time, and perhaps more in the future, our expectations about food will be influenced by an international standard; this trend is discussed in more detail on another web pages at this site.
Government will not decide which foods we eat; instead, government will require disclosure of information about food items and expect consumers to decide for themselves; government will encourage consumer education so they are capable of making appropriate decisions for themselves; government will stop producers, processors, and preparers when goverment believes (based on our understanding of science) the food is unsafe. Government will not regulate what goes on in the home; government will try to influence what goes on in the home through education because we recognize that improper food preparation in the home can also result in food safety issues.
Thus government takes a 3-prong attack --
- processors are required to accurately inform consumers about the food product and must not sell food with inaccurate information (no misbranding),
- processor must not sell food that will make us sick due to what was used to prepare the food, what was added to the food, or how it has been processed (no adulterated food), and
- educate consumers.
Focus is on food safety law but will stray into other topics where food safety interacts with other areas of the law; for example, pesticide residue and environmental law; grocery store regulation and displaying unit prices; food standards and commodity grading; adulteration, biotechnology and intellectual property. These are only a few examples of where food safety blends with other legal issues. The distinction will not always be clear; in those situations, the best approach may be to step back and remind ourselves that our focus are the laws for assuring a safe food supply.
Food Industry Background
Generally, food reaches the consumer 1) needing some final preparation (such as the groceriers purchased in the local store) or 2) ready for consumption from a dine-in or carry-out resturant, vending machine, school cafeteria, hospital, nursing homes, or other institutions that provide prepared meals/food. However, the number of producers, commodities and products, processors, vendors, and other firms involved with food substantially increases the complexity of the industry. Likewise, the globalization of the industry further complicates the "machine" that feeds the world's human population. It is within this complex of intertwined relationships that the need to assure a safe food supply has to be addressed.
Organizing the topics
To keep this complex topic understandable, we will categorize the various topics to be addressed. For example, we will divide the industry into several broad categories, such as production of ag commodities, processing of commodities into products, and preparing the products for consumption. The categories of government will likely follow US federal government, state government, and emerging international standards. Ag commodities will fit into broad categories such as grain, meat, poultry, fish, dairy, eggs, fruit and vegetables. There will also be products, such as infant formulas. Prohibitied acts generally will fit into the broad categories of adulteration and misbranding. Also, let's not forget about anticipating malicious attacks on our food system; that is, bio-terrorism intended to interrupt our food supply.
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Food Safety Concerns, Government Strategies, Prohibited Acts, and Required Actions
What are we worried about?
Production of Ag Commodities and Related Concerns
Production concerns for raw ag commodities (grains, livestock (red meat, poultry) , fruit, vegetables, fish and milk)
- what inputs are being used and will they leave residues in the raw commodities?
- will there be an environmental impact;
- how do we address these safety and quality concerns for domestically produced commodities?
- how do we address these concerns for imported commodities?
- how do we address these concerns for commodities that will be exported?
- is there a distinction between a commodity that will be used for human consumption and a commodity that will be used as livestock feed (this question especially applies to grain)?
What is the quality of the commodity being sold by the producer? Are these standards to protect the buyer of the commodities or the final consumer? What steps are being taken to assure traceability of food back to the producer?
Processing Commodities into Food Products and Related Concerns
What steps must the processor take to assure the product is safe at the completion of processing and packaging? What steps must be taken to preserve information about the source of inputs that are blended during processing? What steps are taken to assure safety of imported processed products?
Preparing Food and Related Concerns
What steps must be taken to assure the product does not become unsafe during transportation and storage? What steps must be taken to assure the product does not become unsafe as the product is marketed to consumers? What steps must be taken to assure the product does not become unsafe as the product is prepared for immediate sale and consumption?
Government's "3-Prong" Approach
Provide overview of history of how these strategies have evolved/been refined since the early 1900s.
Will not tell consumers what to eat. Instead, has adopted a strategy of _________.
Introduce strategies for addressing these concerns -- product standards, sanitation standards, inspections, labeling, etc
- Adulteration
- using safe inputs -- commodity not spoiled or diseased, additive not harmful/poison, commodity not harmful/biotechnology
- what is being added -- color additives, food additives, dietary supplements (vitamins and minerals)
- not being contaminated during processing -- sanitation; HACCP
- anticipating malicious attack on food supply/food system
- Misbranded
- revealing infomation to consumer
- accruately identified/standards for product
- no misleading claims/advertising/labels
- Educate
- so consumers have idea as to what they should consume
- this relates to misbranding/labeling so informed consumer can make decision appropriate for them
Prohibited Acts
Expand on description of prohibited acts of adulteration (additives, sanitation) and misbranding (labeling and adverstising).
Required Actions
labeling
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Process of creating and enforcing food law
- US
Federal government
- Creating
the law
- statutes
- regulations
- identify the various agencies that have been given responsibility for implementing the nation's food safety effort and their interaction
- case law
- Enforcing
the law
- Agencies
- Injunction, seizure, penalties, mandatory recalls, voluntary recalls, stop inspecting
- court case
- Agencies
- Creating
the law
- State governments
- Federal law preempts
- Reflects federal minimum standards
- Enforcement includes cooperating with federal agenices
- Emerging International
Standards
- By treaties, thus voluntary but market provides "incentives"
Where to find laws
Federal and state statutory and regulatory codes; federal register for recently announced regulations; court decisions
Where to find agency explanations
Responsible agencies frequently describe their authorities and their implementation practices; these explanations provide invaluable insights into the agency's perception of its role.
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Expand on description of production, processing and preparation.
Production
- the focus at this point in the industry is on the ag commodity, such as grain, fruit, livestock
- dairy - license to sell raw milk, farm inspections
- meat - beef production (cow-calf, feedlots), use of medication, imported animals
- grains - distinguish between grain for human consumption and grain for livestock feed (animal food)
- organic standards under USDA
- preparing commodity for exports
- accepting commodity imports
Expand on description of ag commodities of grain, meat, poultry, fish, dairy, eggs, fruit and vegetables.
EPA and pesticide residue
Standards and grades (do not directly relate to food safety)
Traceability -- market driven, COOL, etc
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Expand on description of food products
standards
also infant formula.
- Processing
- at this point in the food industry, the emphasis is on food products produced from ag commodities and the process by which the commodity is converted to a product; some products retain many of the characteristics of the underlying commodity (e.g., a beef steak) while others are highly commingled with products of other commodities (e.g., a frozen pizza).
- dairy - product (identity) standards, facility standards, inspections
- meat - slaughter and processing (inspections, packaging), product (identity) standards,
- products from commingling commodities, e.g., frozen dinners
- additives (GRAS)
- processing procedures (GMP)
- infant formula receives special attention
- preparing product for exports
- accepting product imports
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- Preparation
- at this point in the food industry, the focus shifts to the distribution channel, e.g., grocery/retail store v. dine-in resturant v. carry-out resturant v. institution
- read-to-eat
- food establishments and food code
- institutions that prepare meals
- sale for home preparation -- labeling, unit-price?
- home preparation -- education and subsidies to encourage better eating decisions, e.g., WIC/food stamps
A Description Of The U.S. Food Safety System
Center for Food Safety and Applied Nutrition; Food an Drug Administration, Department of Health and Human Services
Food Safety and Inspection Service, Department of Agriculture
Pesticide Residue on Food, Environmental Protection Agency
Where food is produced and processed and where it is consumed
-
domestic production and domestice consumption
-
imports -- foreign production and domestic consumption
-
exports -- domestic production and foreign consumption
Categories of problems
-
accidental problems
-
intentional problems
-
undisclosed accidental problems
Government takes role in assuring safe food
-
a little history of food safety
-
government process -- 3 branches of government; federal and state; admninistrative process
-
3 sources of law -- statutes, regulations, court decisions
Agencies with responsibility for assuring safe food at this time
-
FDA -- non-specified red meats and non-specified birds; food labelling; food additives; dietary supplements; food-borne illness; HACCP under FDA; food ingredients and packaging;
-
USDA -- Meat, poultry, egg inspection acts; dairy, honey, grains, fruits/vegetables; HACCP under USDA
-
EPA
-
others federal agencies?
-
State role in food safety
Examples of how these issues arise and how they are resolved.
-
address topic from perspective of a firm with a problem; not the perspective of an agency; this should help suggest a process to solve problems and demonstrates the interplay among the agencies in the real world
History of additives and cleanliness
-
Food and Drug Act (1906) -- Regulate some food processing and food additives to protect consumers
-
Food, Drug, and Cosmetic Act (1950s)
-
Monitor chemical residue on food to protect consumers
-
Included the Delaney clause; no detectable level of residue of carcinogens would be tolerated
- Pesticide residue, especially if cancer-causing; Delaney clause and its recent refinement
Hazard Analysis and Critical Control Point -- the following is an excerpt from this link.
"Under HACCP, a plant analyzes its processes to determine at what points hazards might exist that could affect the safety of its products. These points are called critical control points (CCPs). Examples of critical control points are chilling; the cooking process; processing procedures, such as filling and sealing cans; and certain slaughter procedures, such as removal of internal organs. The location and number of hazards will differ greatly depending on type of facility, foods prepared, processing procedures used, and many other factors. Once the CCPs are identified, the plant must establish critical limits. Critical limits are usually expressed as numbers representing such parameters as time/temperature, humidity, water activity, pH, salt concentration, and chlorine level. Critical limits may be in the regulations, such as the requirement that poultry be chilled to 40 degrees F., or they may be established by the plant based solely on the scientific and technical literature or recommendations of experts. Next, the plant establishes monitoring requirements for each CCP and corrective actions to be taken when monitoring indicates there is a deviation from an established critical limit. Examples of corrective actions are adjusting the process, holding and destroying all product if it cannot be brought into compliance, and developing an alternative process. The plant must alsoestablish record keeping procedures that document the operation of the HACCP system and verify that controls are working as intended.
"Under the new rule, all plants must develop and implement a HACCP plan for each of their processes. HACCP plans must conform to the seven HACCP principles established by the National Advisory Committee for Microbiological Criteria for Foods. (See the HACCP Key Facts.) HACCP plans are required to cover those CCPs that affect product safety, as opposed to those related to economic adulteration, labeling, or quality concerns. Other quality assurance and inspection measures will continue to address these areas. Plants are required to validate their own HACCP plans--that is, ensure that the plans do what they were designed to do. FSIS will not approve HACCP plans in advance but will review them for conformance with the final regulations."
Food safety under FDA, USDA, etc
Food safety "Principal federal regulatory organizations responsible for providing consumer protection are the Department of Health and Human Services' (DHHS) Food and Drug Administration (FDA), the U.S. Department of Agriculture's (USDA) Food Safety and Inspection Service (FSIS) and Animal and Plant Health Inspection Service (APHIS), and the Environmental Protection Agency (EPA)." source
Food Quality Protection Act (1996)
-
Delaney Clause revisited because modern technology are detecting levels of carcinogens in ever-decreasing amounts; some would argue even to the point that naturally occurring carcinogens would fall within the scope of the law.
-
Pesticide residues are not intentional additives, but are indirect additives and contaminants.
-
EPA will have to set thresholds for toxicants in food.
-
There will a be a weighing of benefits and risks
- Food labeling
- Biotechnology?
-
Regulation of biotechnology
Who owns the genetic materials we produce?
- Plant variety protection act
-
- Addresses sexual reproduced plants; information about asexual plant reproduction is addressed as a patent.
Previous statutes were amended in 1994
- plant patenting
- biotechnology
- contractual relations
How about country of origin labelling?
How about identification of livestock?
Email David.Saxowsky@ndsu.edu
This material is intended for educational purposes
only. It is not a substitute for competent legal counsel. Seek appropriate
professional advice for answers to your specific questions.
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