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Introduction to Food Law
Overview of US Food Law
Government "Players" Involved in US Food Law
Requirements for Food Businesses

Producer/Processor/Preparer Liability
Looking Forward/Future Issues

Historically, food safety was an issue primarily for the processing sector of the industry, but it is now recognized that a food safety problem can originate at any stage in the food system even if it does not manifest itself until the food is consumed. Accordingly, producers of agricultural commodities, such as grain, vegetables, fruits and livestock, need to consider how production practices impact the safety of the final food product. Restated, it is well-recognized that the challenge of assuring a safe food supply extends from "farm to table."

Early government involvement in production agriculture often focused on establishing commodity standards, expanding market opportunities, and promoting utilization to strenghten the agriculture and rural economies, and at various times, addressing financial stress in the production sector.  The role of government in production agriculture expanded during the 20th century with the need to also address water and soil conservation, and environmental considerations.  The scope of government involvement in production agriculture is expanding again as the challenges of assuring a safe and secure "farm-to-table" food supply become more clearly understood.

The purpose of this page is to overview government activities that impact production agriculture; that is, a broad definition of food law. The latter portion of the page emphasizes food safety concerns.

  • The focus in the production (sometimes called pre-harvest) stage of the food industry is on the basic ag commodities of grain, livestock, poultry, fish, dairy, eggs, fruit and vegetables.
  • Recognizing that food safety concerns need to be addressed "farm to table" acknowledges that food products begin as agricultural commodities (e.g., grain, fed cattle, milk and vegetables) that are then processed into a food product (e.g., a frozen cheese and meat pizza).

The overview begins with a brief description of ag commodity standards.

Commodity standards

Historically, a critical issue in production agriculture was whether buyers were receiving the type and quality of commodities they anticipated. To resolve such quality disputes, government established standards and grades.

  • "The Secretary of Agriculture is directed and authorized: ... (c) To develop and improve standards of quality, condition, quantity, grade, and packaging, and recommend and demonstrate such standards in order to encourage uniformity and consistency in commercial practices." 7 U.S.C. 1622.
  • However, the historical purpose for commodity standards did not focus on food safety concerns.
    • "Quality grades provide a common language among buyers and sellers, which in turn assures consistent quality for consumers. Certification services, which facilitate ordering and purchase of products used by large volume buyers, assure these buyers that the products they purchase will meet the terms of the contract -- with respect to quality, processing, size, packaging, and delivery."  Excerpt from AMS (USDA) Grading and Certification
    • " AMS’ quality grade standards, grading, certification, auditing, inspection, and laboratory analysis are voluntary tools that industry can use to help promote and communicate quality and wholesomeness to consumers."  (source)
  • "GIPSA's Federal Grain Inspection Service (FGIS) establishes the Official Standards for Grain, which are used each and every day by sellers and buyers to communicate the type and quality of grain bought and sold. FGIS also establishes standard testing methodologies to accurately and consistently measure grain quality. Finally, the program provides for the impartial application of these grades and standards through a network of Federal, State, and private inspection agencies known as the official system."
  • Official US Standards for Grain 7 CFR Part 810
    • "Grain refers to barley, canola, corn, flaxseed, mixed grain, oats, rye, sorghum, soybeans, sunflower seed, triticale, and wheat. Standards for these food grains, feed grains, and oilseeds are established under the United States Grain Standards Act." 7 CFR 810.101
    • Example:  Grades and grade requirements for corn at 7 CFR 810.404.
  • The Agriculture Marketing Service (AMS) of USDA offers "quality grading (a user-fee service) ... based on the standards developed for each product. Grading services are often operated cooperatively with State departments of agriculture. Quality grades provide a common language among buyers and sellers, which in turn assures consistent quality for consumers. Certification services, which facilitate ordering and purchase of products used by large volume buyers, assure these buyers that the products they purchase will meet the terms of the contract -- with respect to quality, processing, size, packaging, and delivery."  The primary focus is not necessarily on assuring the commodity will not cause a food safety concern. http://www.ams.usda.gov/gac/
  • Official US Standards for Grades of Livestock AMS (USDA);
  • State governments also have a role in defining standards for agricultural commodities. For example:
    • "The [ND agriculture] commissioner may establish commodity grades and inspection services [for any agricultural product of the soil for which grades, standards, or inspection services ... have not been established by the United States department of agriculture] for the purpose of making inspection and otherwise providing for the proper handling and marketing of the agricultural commodities." N.D.C.C. 4-09.1-02.
  • Note that both state and federal governments have established standards and grades; but also note that the state law, for example the North Dakota law, applies only to those commodities that the federal government has not addressed. This distinction helps clarify what at times appears to be a complex body of law.
  • Accommodating the historical purposes for commodity standards while addressing more recent concerns for safe food in domestic and international markets has led to some changes.
    • Also note "Note: Compliance with the provisions of these standards does not excuse failure to comply with the provisions of the Federal Food, Drug, and Cosmetic Act, or other Federal laws."  7 CFR 810.101.  Obviously, USDA in promulgating these standards recognizes a relationship between commodity grades and the ultimate food product.
    • The intent is to protect/inform buyers and sellers by establishing standards; the intent of establishing standards was not originally focused on food safety concerns. However, the standards can impact the issue of food safety; for example, moldy grain that forms a toxin which remains in the baked product and is dangerous for human consumption would fit the definition of adulterated. Even though the primary purpose of the law may not be food safety concerns, there can be a relationship.
  • These standards were not intended to assure safety -- but as they evolve, will their purpose change?

 

Financial Protection for Sellers

A second "production ag" issue addressed by government is assuring that market would not be controlled by several large buyers or sellers:

  • "The Agency's Packers and Stockyards Programs (P&S) ensure open and competitive markets for livestock, meat, and poultry. P&S is a regulatory program whose roots are in providing financial protection, and ensuring fair and competitive markets."

Some statutes were intended to assure that sellers were paid.

  • "Financial Protection.  Payment protection for the sellers of livestock is an integral part of the Act and of extreme importance to PS&P [Packers and Stockyards Programs]. To ensure compliance with the financial and payment protection provisions of the Act, P&SP audits and investigates the regulated industry.

"Market agencies that sell livestock on a commission basis are required to establish and maintain, for the benefit of livestock sellers, a Custodial Account For Shippers' Proceeds bank account." Excerpt from expired web site.

see http://www.gipsa.usda.gov/GIPSA/webapp?area=home&subject=lpf&topic=pp

  • A state-level example: Regulation of Wholesale Potato Dealers -- N.D.C.C. CHAPTER 4-11
    • Wholesale potato dealer must be licensed. N.D.C.C. 4-11-02.
    • "Form of security to accompany application for license. . The form of security required by the [ND agriculture] commissioner must be conditioned for the faithful performance of the applicant's duties as a wholesale potato dealer, for compliance with all laws and rules relating to the purchase of potatoes by the dealer, for prompt payment in the case of insolvency, and for the protection and benefit of any potato producer in this state." N.D.C.C. 4-11-04.
    • Inspection of potatoes - Right to demand - Certificate of inspection.

1. Whenever potatoes are ready for sale ... any ... interested party ... is entitled to inspection of the potatoes.

2. Whenever potatoes are shipped to or received by a wholesale potato dealer ... and the dealer ... finds the potatoes to be spoiled, damaged, unmarketable, in unsatisfactory condition, mislabeled, or misrepresented in any way ... the wholesale potato dealer shall cause the potatoes to be examined by an inspector assigned by the commissioner. N.D.C.C. 4-11-16.

 

Promotion of Ag Sectors

The objective of some programs is to strengthen the local economy by promoting the use of the commodity. Several examples:

  • "The Egg Research and Consumer Information Act of 1974 authorized a national egg research and promotion program that is both industry-operated and funded, with oversight by the U.S. Department of Agriculture. The act allows the Secretary of Agriculture to establish a board of egg producers or representatives of producers.

"The American Egg Board is responsible for developing a program to enable egg producers to establish, finance, and carry out a coordinated program of research, producer and consumer education, and promotion to improve, maintain, and develop markets for eggs, egg products, spent fowl, and products of spent fowl." Excerpt from http://www.ams.usda.gov/poultry/pyrp.htm .

  • "The production, development, marketing, and promotion of dry beans in this state is important to the general welfare of the people of North Dakota. It is in the public interest that better methods of production, processing, and marketing of dry beans and that advertising and promoting of dry beans grown in this state be fostered, encouraged, developed, and improved so the dry bean industry within the state, the people directly or indirectly employed by said industry and the people of North Dakota should be benefited thereby, the accomplishment of which requires and demands the establishment of a North Dakota dry bean council for the purposes and with the objectives of contributing to the stabilization and improvement of the agricultural economy of this state." N.D.C.C. 4-10.3-01.

 

Protection Against Diseases and Pests

Government also is involved in addressing the risk of disease or pests that may destroy the production of agricultural commodities.

 

  • Although these rules do not directly address the safety of the final food product, they are an important component of assuring a viable food industry in the future. The issues addressed by these rules deal more with the production of ag commodities than with food safety, but they are still part of "food law."

 

Early Safety Concerns and Ag Commodities

Concerns whether an ag commodity could lead to a food safety issue was a secondary consideration in the development of these laws. But there are exceptions; the dairy industry is such an example.

  • "Any milk ... produced from animals which are diseased or fed unwholesome, impure, or toxic feed, or milk which tastes from colostrum, shall be deemed impure and unwholesome. No milk or milk product which is deemed to be adulterated, impure, or unwholesome may be transported, stored, sold, or offered for sale in this state. N.D.C.C. §4-30-40.

Dairy - license to sell raw milk, farm inspections - state and local regulation/inspection

However, once the commodity reaches the processing stage, the quality of the commodity and its impact on the intended food product is addressed directly.

  • 21 CFR 110.80 (a)(1) and (2)

    (1) Raw materials and other ingredients shall be inspected and segregated or otherwise handled as necessary to ascertain that they are clean and suitable for processing into food. (2) Raw materials and other ingredients shall either not contain levels of microorganisms that may produce food poisoning or other disease in humans.

  • 21 CFR 110.3 (i) and (j)

    (i) Microorganisms means yeasts, molds, bacteria, and viruses and includes, but is not limited to, species having public health significance. The term "undesirable microorganisms'' includes those microorganisms that are of public health significance, that subject food to decomposition, that indicate that food is contaminated with filth, or that otherwise may cause food to be adulterated within the meaning of the act.

 

Additional Examples

Livestock production (e.g., cow-calf, feedlots) --

Grains - distinguish between grain for human consumption and grain for livestock feed

  • See 21 CFR Parts 500-589; these regulations address livestock feed and pet food. Our focus is on feed for livestock intended for human food; thus we need to distinguish between regulations that apply primarily to pet food and those that target livestock feed.  You will note that the regulations address issues such as feed (animal food) additives, GRAS for feed, labeling, etc. 

Poultry --

"The Department cooperates through a Memorandum of Understanding with Official State Agencies in the administration of the Plan."

NDAC "7-11-01-03. Labeling and sales requirements.  1. Farm flock requirements. The farm flock requirements for egg production is a voluntary program."

Seafood --

Fruits and vegetables -- example: e-coli found on fresh vegetables was traced back to wild animals entering the fields prior to harvest (this situation arose in 2006). An issue is that processors are demanding that producers take steps to reduce presence of wildlife but that such production practices are contrary to programs that encourage producers to retain natural areas for wildlife and environmental reasons. Thus producers are finding themselves between competing objectives of removing natural areas to reduce risk of e-coli contamination and retaining natural areas for the benefit of wildlife and environmental protection.

Another example: "shipments of vegetables or other edible food in used crates or containers that may render the contents injurious to health;" see 21 CFR §2.35

USDA AMS GAP

 

Environmental and Residue Concerns

Early concerns about the environment focused on the impact of production practices on soil and water resources, such as chemical application and manure management (e.g., see NRCS and EPA regulating CAFOs).  But at the same time, some consumers were interested in food that was produced without chemicals or fertilizers, which led to the National Organic Program.

Organic standards under USDA (AMS)

"SUMMARY : This final rule establishes the National Organic Program (NOP or program) under the direction of the Agricultural Marketing Service (AMS), an arm of the United States Department of Agriculture (USDA). This national program will facilitate domestic and international marketing of fresh and processed food that is organically produced and assure consumers that such products meet consistent, uniform standards. This program establishes national standards for the production and handling of organically produced products, including a National List of substances approved for and prohibited from use in organic production and handling. This final rule establishes a national-level accreditation program to be administered by AMS for State officials and private persons who want to be accredited as certifying agents. Under the program, certifying agents will certify production and handling operations in compliance with the requirements of this regulation and initiate compliance actions to enforce program requirements. The final rule includes requirements for labeling products as organic and containing organic ingredients. This final rule also provides for importation of organic agricultural products from foreign programs determined to have equivalent organic program requirements. This program is authorized under the Organic Foods Production Act of 1990, as amended."

More recently, the concern of pesticide residue in food has been addressed as a food safety issue.

  • Pesticide residues (Food Quality Act of 1996)

    "On August 3, 1996, President Clinton signed into law the most significant piece of pesticide and food safety legislation enacted in many years, the Food Quality Protection Act (FQPA) of 1996. The new law requires major changes in pesticide regulation and affords EPA unprecedented opportunities to provide greater health and environmental protection, particularly for infants and children.

    "Many pesticides, even when they are applied legally, in accordance with label directions, may leave residues in or on treated fruits, vegetables, grains and other commodities. Though pesticide residues often decrease over time as food crops are washed, stored, processed, and prepared, some residues may remain in both fresh produce (like apples or tomatoes) and processed foods (like applesauce or tomato catsup).

    "To ensure the safety of the U.S. food supply, EPA sets tolerances, or maximum residue limits, on the amount of pesticide residue that can lawfully remain in or on each treated food commodity. In establishing tolerances, EPA considers the toxicity of each pesticide, how much of the pesticide is applied and how often, and how much of the pesticide (i.e., the residues) remains in or on food. An added extra margin of safety ensures that residues remaining in foods are many times lower than amounts that could actually cause adverse health effects.

    "The pesticide tolerances set by EPA are enforced by the Food and Drug Administration, which monitors domestically produced and imported foods traveling in interstate commerce except meat, poultry, and some egg products."

    Excerpts from http://www.epa.gov/pesticides/factsheets/securty.htm

Pesticide chemicals in food (40 CFR Part 180)

 

More recent developments

 

  • Bioterrorism (Public Health Security and Bioterrorism Preparedness and Response Act of 2002)

    "...[D]irect[s] the Secretary to give high priority to increasing the number of inspections of food offered for import with the greatest priority given to inspections to detect intentional adulteration.

    "Directs the Secretary to give high priority to making improvements to the FDA information management systems for imported foods to improve our ability to allocate resources, detect intentional adulteration, and facilitate the importation of food that is in compliance with the Act."

    Excerpts from http://www.cfsan.fda.gov/~dms/sec-ltr.html#attach-a

Also see AGRICULTURAL BIOTERRORISM at http://www.aphis.usda.gov/ppq/permits/agr_bioterrorism/

Sections 201 through 231 of "the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Enhancing Controls on Dangerous Biological Agents and Toxins) provides for the regulation of certain biological agents and toxins by the Department of Health and Human Services and the Department of Agriculture, and provides for interagency coordination between the two departments regarding overlap agents and toxins. Section 231provides for criminal penalties regarding certain biological agents and toxins. For the Department of Health and Human Services, the Centers for Disease Control and Prevention (CDC) has been designated as the agency with primary responsibility for implementing the provisions of the Act; the Animal and Plant Health Inspection Service (APHIS) is the agency fulfilling that role for the Department of Agriculture (USDA). ... [S]ection 212(a) provides, in part, that the Secretary of Agriculture must establish by regulation a list of each biological agent and each toxin that she determines has the potential to pose a severe threat to animal or plant health, or to animal or plant products. [S]ection 213(b) requires that all persons in possession of any listed biological agent or toxin must, within 60 days of the publication of that interim rule, notify the Secretary of such possession.

taken from http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2002_register&docid=fr13de02-15

 

Traceablity and Product Liability (domestic commodities)

"establish requirements regarding the establishment and maintenance, for not longer than two years, of records by persons (excluding farms and restaurants) who manufacture, process, pack, transport, distribute, receive, hold, or import food. The records that must be kept by these regulations are those that are needed by the Secretary for inspection to allow the Secretary to identify the immediate previous sources and immediate subsequent recipients of food, including its packaging, in order to address credible threats of serious adverse health consequences or death to humans or animals."

 

Commodity imports

"The Secretary of Agriculture may by regulation prohibit or restrict the importation or entry of any cattle, sheep, or other ruminants, or swine, that are diseased or infected with any disease, or that have been exposed to an infection, into or through the United States to prevent the dissemination into the United States of a disease." 21 U.S.C. 104(a).

Country of Origin Labeling (COOL) and traceability of foreign commodities

"Farm Security and Rural Investment Act of 2002, more commonly known as the 2002 Farm Bill . requires country of origin labeling for beef, lamb, pork, fish, perishable agricultural commodities and peanuts. As described in the legislation, program implementation is the responsibility of USDA's Agricultural Marketing Service."

  • Is this a food safety issue, a concern about disease risk to our production sector, or a concern about foreign competition?

 

Commodities export

http://www.ams.usda.gov/lsg/lsint.htm

International Office of Epizootics (OIE)

  • Health and sanitary requirements for import and export of animals
  • World wide reporting system for livestock diseases

Animal and Plant Health Inspection Service (APHIS) at USDA

 

International Plant Protection Convention (IPPC)

  • Develop plant quarantine requirements
  • Prevention of the international spread of plant pests and diseases

Animal and Plant Health Inspection Service (APHIS) at USDA

 

Producer education is an alternative to regulating production practices to minimize the risk of a food safety problem. One example of such an educational program is the Good Agricultural Practices (GAPs) Project.  Another example is the Beef Quality Assurance Program.

Also consider

Product safety educational programs by producer commodity organizations, e.g., swine, beef, poultry, and dairy.

Despite the recognition that food safety needs to be addressed farm to table, most of the pre-harvest efforts still focus on the traditional objectives of assuring the buyer receives the quality commodity they agreed to purchase and to promote the use of the commodity as a way to enhance the economic well-being of the producers and their community. But this appears to be changing.

Emerging Status of Audit-based GAP

Good Agricultural Practices by FAO of the United Nations

See USDA AMS GAP and EUREPGAP and GlobalGAP

European Union Market Development Reports EUREPGAP Update 2003
Date: 10/1/2003; GAIN Report Number: E23187

Example of a U.S. GAP -- Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables --

"... the FDA and USDA are issuing "Guidance for Industry -- Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables." This guidance document ("the guide") addresses microbial food safety hazards and good agricultural and management practices common to the growing, harvesting, washing, sorting, packing, and transporting of most fruits and vegetables sold to consumers in an unprocessed or minimally processed (raw) form. This voluntary, science-based guidance can be used by both domestic and foreign fresh fruit and vegetable producers to help ensure the safety of their produce. The voluntary guidance is consistent with U.S. trade rights and obligations and will not impose unnecessary or unequal restrictions or barriers on either domestic or foreign producers.

"The produce guide is guidance and it is not a regulation. As guidance and if applied as appropriate and feasible to individual fruit and vegetable production operations, the guide will help to minimize microbial food safety hazards for fresh produce. Because it is guidance, and not a regulation, the guide does not have the force and effect of law and thus is not subject to enforcement ..."

 

Will agricultural producers refine their production practices and recordkeeping as a result of government mandates or will the impetus come from the marketplace?

 

Last updated March 18, 2010

   
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