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Rules for Specific Foods

Specific foods have experinced unique food safety issues. This page reviews U.S. government response to these unique situations.

Additional Rules for Specific Foods, such as

  • Acidified and low-acid
  • Infant formula
  • High-risk raw agricultural commodities/food
  • Dietary Supplements
  • Trans Fat (discussion being added to web page)
  • Dairy Industry
  • Raw Milk (discussion being added to web page)
  • Pet Food and Animal Feed (discussion being added to web page)
  • Organic (USDA)
  • Genetically-modified/biotechnology (EPA, USDA  & FDA)

 

See Food Guidance Documents:  Acidified & Low-Acid Canned Foods; Bottled Water & Carbonated Soft Drinks; Cheese Safety; Egg Safety; Fruits, Vegetables & Juices; Infant Formula; Medical Foods; Milk Safety; & Seafood

Also see FDA Dietary Supplements

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Issues (often serious issues) have arisen for several food products in the past.  As a consequence, Congress responded with unique laws to address specific food safety problems.  This page reviews several of these specific food laws.  FDA usually was given responsibility of administering these unique provisions.

FDA Requirements for ... Acidified & Low-Acid Canned Foods

The following paragraphs are excerpts from NSW Food Authority, "Shelf stable acid preserved foods -- Factors affecting the shelf stability of acid foods -- Condiments, sauces and salad dressings", NSW/FA/FI035/0811.  They provide some background information as to why low-acid canned foods have specific regulations.

"Thermally processed acid foods have a good record of food safety and shelf stability... Products that have the right combination of low pH, adequate levels of acetic acid, salt and sugars can be filled without a thermal process and still be safe and stable... However, if products are not properly formulated there can be risks to food safety or shelf stability. In particular poorly acidified foods can lead to botulism and cold filled products with inadequate acetic acid can spoil.

"Most foods on supermarket dry-grocery shelves are shelf stable products. Some foods such as dry pasta and rice are intrinsically shelf stable.

"Other foods rely on a range of technologies to ensure shelf stability. These include the elimination of microorganisms capable of growing in the food system by retorting or UHT processing or by adjusting the environment in the food so that it is not suitable for the growth of microorganisms. Control of water availability, pH reduction, the use of organic acids or preservatives and heat shocks are common methods to inhibit microbial growth.

"Acid and acidified foods are well represented on the supermarket shelf. The determinants of food safety and shelf stability are long established. However, the US Food and Drug Administration (FDA, undated) lists a history of botulism attributed to inadequately acidified foods and notes that products processed by 29 firms were found to be inadequately acidified. [Botulism is caused by the anaerobic, spore-forming microorganism Clostridium botulinum. Although outbreaks of botulism are extremely rare, the consequences can be lifethreatening.]"

End of excerpts

The following paragraph is an excerpt from FDA "Instructions for Establishment Registration and Processing Filing for Acidified and Low-Acid Canned Foods".

"Improperly processed low-acid canned foods or acidified foods present life-threatening hazards; therefore registration of those establishments which manufacture, process, or pack low-acid canned foods or acidified foods and filing of the processes they use are necessary to identify processors and to monitor compliance with the regulations, to provide for immediate application of emergency permit control should a potential public health hazard be identified."

[edited] "The purpose of FDA's requirements for registration, manufacturing, and process filing of low-acid canned foods and acidified foods in hermetically sealed containers is to ensure safety from harmful bacteria or their toxins, especially the deadly Clostridium botulinum (C botulinum). [Ensuring the safety] can only be accomplished by adequate processing, controls, and appropriate processing methods, such as cooking the food at the proper temperature for sufficient times, adequately acidifying the food, or controlling water activity." Taken from FDA web site that is no longer available.

  • "(n) Low-acid foods means any foods, other than alcoholic beverages, with a finished equilibrium pH greater than 4.6 and a water activity (aw) greater than 0.85. Tomatoes and tomato products having a finished equilibrium pH less than 4.7 are not classed as low-acid foods." see 21 CFR §113.3.
  • "(b) Acidified foods means low-acid foods to which acid(s) or acid food(s) are added; these foods include, but are not limited to, beans, cucumbers, cabbage, artichokes, cauliflower, puddings, peppers, tropical fruits, and fish, singly or in any combination. They have a water activity (aw) greater than 0.85 and have a finished equilibrium pH of 4.6 or below. These foods may be called, or may purport to be, "pickles'' or "pickled" ..." see 21 CFR §114.3.

November 2014 link:  "Guidance for Commercial Processors of Acidified & Low-Acid Canned Foods" at http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/AcidifiedLACF/default.htm

    ... Infant Formula

    • "An infant formula, including an infant formula powder, shall be deemed to be adulterated if such infant formula does not provide nutrients as required ..., such infant formula does not meet the quality factor requirements ..., or the processing of such infant formula is not in compliance with the good manufacturing practices and the quality control procedures..."

      See 21 U.S.C. §350a

    • "All manufacturers of infant formula must begin with safe food ingredients, which are either generally recognized as safe (GRAS) or approved as food additives for use in infant formula. Once an infant formula product is formulated, current laws require that the manufacturer must provide FDA assurance of the nutritional quality of that particular formulation before marketing the infant formula. FDA has provisions that include requirements for certain labeling, nutrient content, manufacturers quality control procedures (to assure the nutrient content of infant formulas), as well as company records and reports."

      See 21 CFR 107 (Infant Formula) and 21 CFR 106 (Infant Formula quality control procedures)

      FDA Guidance & Regulatory Information for infant formula

    • Two unique features of the infant formulalaw:
      • Regulatory oversight includes nutrient content; not just safety concerns.  The focus on nutrient content reflects the international concern at that time that infant formula was not providing the nutrition needed by infants and that infants around the world were being malnourished.  
      • FDA is authorized to mandate a recall of unsafe infant formula (21 CFR 107.200 et. seq.).
      • The following excerpt was drawn from http://afterwords.typepad.com/global_marketing/2010/01/nestle-infant-formula-controversy.html
        • "...Nestle Alimentana, one of the world’s largest food-processing companies had been the subject of an international boycott as a result of the accusations that the company was directly or indirectly responsible for the death of Third World infants. The charges were based on the sale of infant feeding formula, which supposedly caused the mass deaths of babies in the Third World.
        • "The charges primarily focus on whether or not the advertising and marketing of these products discouraged breast feeding among Third World mothers and led to misuse of the products. For example, many mothers in Peru used the water which came from a highly contaminated river to dilute the formula, which in turn resulted in formula-fed babies to come down with recurring attacks of diarrhea and vomiting. In some cases, mothers throughout the Third World fill bottles up with a small amount of formula and a large amount of water, depriving babies of nutrients, resulting in extreme malnutrition and in other cases, these mothers relied solely on the formula to feed their children for excessively long amounts of time.
        • "Although many mothers in Third World countries misused the formula, Nestle argued that the company never supported the idea of replacing breast milk with formula, although it plays a vital role in proper infant nutrition as a supplement. The formula was also better in comparison to other supplemental feedings that were harmful to infants, including herbal teas, rice water, corn water and sweetened, condensed milk as these feedings can also be prepared with contaminated water and served in unsanitary conditions."

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    ... Fresh-Cut Fruits and Vegetables

    Several incidents in the past decade demonstrated the food safety risks associated with fresh fruits and vegetables intended to be consumed raw.  Consumers fell ill and some died from these events.  As described on other pages, that often is when government responses -- that is, after a problem. 

    • FDA took steps to address the concern because the ag commodity (the food) was being sold to consumers without further processing.  USDA took steps to address the concern because ag commodity was being handled and packaged on the farm.  Both agencies responded by offering ideas and education as to how producers should handle the produce to reduce the risk of unsafe food.  For example, USDA urged producers to adopt Good Agricultural Practices (GAP) and Good Handling Procedures (GHP).  FDA also developed guidance for producers.
    • Even though there may not have been much public debate, there was some uncertainty as to which agency had jurisdiction over on-farm handling of fresh fruits, vegetables, nuts and other agricultural commodities intended for the raw or fresh market.  FDA was given the lead responsibility when Congress enacted the Food Safety Modernization Act (in early 2011) which explicitly directs the FDA to develop regulations for these agricultural producers and their on-farm packaging and handling.
    • FDA finalized a Produce Safety rule.  The regulation 21 CFR Part 112 .  An FDA guidance document (Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption) also is available.  Key topics in the regulation include
      • Personnel Qualifications and Training
        • Qualifications and training for personnel who handle/contact produce or food contact surfaces
        • Requirements regarding supervisors
      • Health and Hygiene
        • Hygienic practices personnel must use
      • Agricultural Water
        • Requirements for agricultural water sources, water distribution system, and pooling of water
      • Biological Soil Amendments of Animal Origin and Human Waste
        • Handling, conveying, storing and applying biological soil amendments of animal origin and human waste
      • Domesticated and Wild Animals
        • Requirements regarding grazing animals, working animals, and animal intrusion
      • Growing, Harvesting, Packing, and Holding Activities
        • Measures to take if growing, harvesting, packing or holding produce
      • Equipment, Tools, Buildings, and Sanitation
        • General requirements regarding equipment, tools and buildings
        • Subtopics include measuring instruments and controls, transport of produce, nearby domesticated animals, pest control, toilet and handwashing facilities, disposal of sewage and trash, and plumbing
      • Records
        • Records must 1) include name and location of farm, values observed during monitoring, description of produce, location of a growing area, and date and time of the activity; 2) be created at the time an activity is performed or observed; 3) be accurate, legible, and indelible; and 4) be dated, and signed or initialed by the person who performed the activity.
    • Despite FDA's role in this sector of the food industry, USDA AMS offer suggestions and auditing service of production practices for agricultural producers.  See Good Agricultural Practices (GAP) & Good Handling Practices (GHP).

     

    … Dietary Supplements

    • "FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products..."
    • Overview of Dietary Supplements(an FDA web page with frequently asked questions about dietary supplements; appears to be a good place to start your reading on this topic)
      • "A dietary supplement is a product taken by mouth that contains a "dietary ingredient" intended to supplement the diet. The "dietary ingredients" in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders... [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."
    • Congress defines dietary supplements as food and thus they are not regulated as a drug
    • "... the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. Generally, manufacturers do not need to register with FDA nor get FDA approval before producing or selling dietary supplements. Manufacturers must make sure that product label information is truthful and not misleading."
    • Vitamins and minerals 21 U.S.C. §350; this section encompasses dietary supplements.

    [edited] "A dietary supplement is a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total dietary intake (e.g., enzymes or tissues from organs or glands), or a concentrate, metabolite, constituent or extract."

    [edited] "A new dietary ingredient is a dietary ingredient that was not sold in the U.S. in a dietary supplement before October 15, 1994. A manufacturer or distributor must notify FDA if the business intends to market a dietary supplement in the U.S. that contains a new dietary ingredient. The manufacturer (and distributor) must demonstrate to FDA why the ingredient is reasonably expected to be safe for use in a dietary supplement, unless it has been recognized as a food substance and is present in the food supply." "There is no authoritative list of dietary ingredients that were marketed before October 15, 1994. Therefore, manufacturers and distributors are responsible for determining if a dietary ingredient is "new", and if it is not, for documenting that the dietary supplements its sells, containing the dietary ingredient, were marketed before October 15, 1994."

    • The Proxmire Amendment (Sec. 411 FDCA, codified at 21 U.S.C. §350) prohibits FDA from specifying "maximum limits on the potency of any synthetic or natural vitamin or mineral within a food"
      • "...the Secretary may not establish ... maximum limits on the potency of any synthetic or natural vitamin or mineral within a food; the Secretary may not classify any natural or synthetic vitamin or mineral (or combination thereof) as a drug solely because it exceeds the level of potency which the Secretary determines is nutritionally rational or useful; the Secretary may not limit... the combination or number of any synthetic or natural vitamin, mineral, or other ingredient of food ...
      • "[This prohibition] shall not apply in the case of a vitamin, mineral, other ingredient of food, or food, which is represented for use by individuals in the treatment or management of specific diseases or disorders, by children, or by pregnant or lactating women." 21 CFR 190
    • Labeling -- A Dietary Supplement Labeling Guide
      • Five statements are required on the package of a dietary supplement: 1) the statement of identity (name of the dietary supplement), 2) the net quantity of contents statement (amount of the dietary supplement), 3) the nutrition labeling, 4) the ingredient list, and 5) the name and place of business of the manufacturer, packer, or distributor.
      • The statement of identity and the net quantity of contents statement must appear on the principal display panel.
      • The information panel must contain the "Supplement Facts" panel, the ingredient list, and the name and place of business of the manufacturer, packer, or distributor if such information does not appear on the principal display panel.
      • The "Supplement Facts" panel is used on dietary supplements in place of the nutrient label that is required for food products.  The major differences between "Supplement Facts" panel and "Nutrition Facts" panel are
        • A supplement facts panel must list dietary ingredients without RDIs or DRVs.
        • A supplement facts panel may list the source of a dietary ingredient.
        • A dietary ingredient does not have to be listed in the ingredient statement for dietary supplements if it is listed in the supplement facts panel.
        • The part of the plant from which a dietary ingredient is derived must be listed in the supplement facts panel.
        • "Zero" amounts of nutrients are not allowed in the supplement facts panel for dietary supplements.

    November 2014 link:  "Dietary Supplements Guidance Documents & Regulatory Information" at http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/DietarySupplements/default.htm

     

    ... Trans Fat

    FDA determined that partially hydrogenated oils (PHOs) are not generally recognized as safe (GRAS) based on research into the effects of PHOs, as well as input from stakeholders.  PHOs are the primary dietary source of artificial trans fat in processed foods. Removing PHOs from processed foods could prevent heart attacks and deaths.

    FDA has set summer of 2018 as the intended compliance date to allow food companies to either reformulate products without PHOs and/or petition the FDA to permit specific uses of PHOs.

    Final Determination Regarding Partially Hydrogenated Oils (Removing Trans Fat)

     

    ... Dairy Industry

    "State and local regulatory agencies are responsible for the enforcement of sanitation requirements on dairy farms, in processing plants, dry milk plants, receiving and transfer stations (establishments where raw milk or cream is received for further transport). The Public Health Service has no legal jurisdiction in the enforcement of milk sanitation standards except on interstate carriers and milk and milk products shipped in interstate commerce. FDA's primary function under the Federal/State Milk Safety Cooperative Program (IMS Grade A products) is to provide technical assistance to the states in the implementation and enforcement of their milk regulations. This assistance is provided through the district and regional milk specialists and the Center for Food Safety and Nutrition's (CFSAN), Milk Safety Branch.

    "To assist states and municipalities in initiating and maintaining effective programs for prevention of milkborne diseases, the Public Health Service developed (in 1924) a model regulation known as the Standard Milk Ordinance for voluntary adoption by state and local milk control agencies. This model milk ordinance, now titled "Grade A Pasteurized Milk Ordinance" (PMO), also provides administrative and technical details as to satisfactory compliance with the ordinance. The ordinance is incorporated by reference in federal specifications, for procurement of milk and milk products served on interstate carriers, and is recognized by public health agencies and the milk industry as a national standard for milk sanitation.

    "FDA is responsible for direct inspectional coverage of all non-grade A products shipped in interstate commerce which include: Milk & Milk Products, Butter, Dried Milk Products, Cheese & Cheese Products, Ice Cream & Related Products (frozen desserts), Filled Milk & Imitation Milk Products."

    Excerpt from Dairy Products Manufacturers (4/95), copied April 23, 2015

     
     
    GRADE “A” PASTEURIZED MILK ORDINANCE (excerpts)
     
    An Ordinance
    • defining "milk" and certain "milk products", "milk producer", "pasteurization",etc.;
    • prohibiting the sale of adulterated and misbranded milk and milk products;
    • requiring permits for the sale of milk and milk products;
    • regulating the inspection of dairy farms and milk plants;
    • the examination, labeling, pasteurization, aseptic processing and packaging and distribution and sale of milk and milk products;
    • providing for the construction of future dairy farms and milk plants...

     

    "The USPHS/FDA does not have legal jurisdiction in the enforcement of milk sanitation standards, except on interstate carriers and milk and milk products shipped in interstate commerce. It serves solely in an advisory and stimulative capacity and its program is designed primarily to assist State and Local Regulatory Agencies. Its aim is to promote the establishment of effective and well-balanced milk sanitation programs in each State; to stimulate the adoption of adequate and uniform State and Local milk control legislation; and to encourage the application of uniform enforcement procedures through appropriate legal and educational measures.
     
    "When this Ordinance is adopted locally, its enforcement becomes a function of the Local or State authorities. Consequently, the Ordinance should be adopted only if adequate provisions can be made for qualified personnel and for suitable laboratory facilities."
     
     

    ... Raw Milk

    FDA does not allow raw milk to be transported across state line; FDA does not prohibit raw milk from being produced, sold and consumed in intrastate commerce.  It is up to the state to regulate raw milk within each of their states.

    States vary as to how they regulate intrastate raw milk.  This site does not attempt to keep up with changing state laws but urges interested persons to seek credible sources of law to learn the status of raw milk in any particular state.

     

    I would suggest that "raw milk" does not mean "unregulated milk."  For example:

    Does the farm need to meet Grade A standards to produce raw milk for the liquid (beverage) market?

    What additional standards (USDA NOP standards) need to be met for the raw milk to also be considered organic milk?  Can organic milk then be processed into organic cheese and other dairy products?

    Do firms that bottle raw milk for the beverage market need to meet GMPs?  Do firms that process raw (organic?) milk into organic cheese and other dairy products need to meet GMPs?  Does FSMA emerging standards for raw ag commodities processed on the farm suggest standards or practices that on-farm processing of raw milk may need to meet in the future?


    The U.S. federal government is cautious about raw milk and has numerous publications addressing the topic.  For example, FDA links on raw milk include "Raw Milk & Pasteurized Milk" at http://www.fda.gov/Food/PopularTopics/ucm293042.htm; and "The Dangers of Raw Milk: Unpasteurized Milk Can Pose a Serious Health Risk" at https://www.fda.gov/Food/resourcesForYou/consumers/ucm079516.htm.  Also see CDC's "Food Safety and Raw Milk" at http://www.cdc.gov/foodsafety/rawmilk/raw-milk-index.html and "Raw Milk Questions and Answers" at https://www.cdc.gov/foodsafety/rawmilk/raw-milk-questions-and-answers.html.

    FDA also permits cheese manufactured from raw milk as long as the cheese is aged at least 60 days; see "Summary Report: Raw Milk Cheese Aged 60 Days" at https://www.fda.gov/downloads/Food/ComplianceEnforcement/Sampling/UCM512217.pdf.

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    ... Pet Food and Animal Feed

    Pet Food at http://www.fda.gov/AnimalVeterinary/Products/AnimalFoodFeeds/PetFood/default.htm

    "FDA's Regulation of Pet Food" at https://www.fda.gov/AnimalVeterinary/ResourcesforYou/ucm047111.htm .

     

    Animal Food and Feeds: Product Regulation at http://www.fda.gov/AnimalVeterinary/Products/AnimalFoodFeeds/ucm050223.htm

    "FSMA Final Rule for Preventive Controls for Animal Food" at https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm366510.htm

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    USDA Requirements for … Organic food

    -- see organic commodities; discussed as part of commodity production and labeling.  Organic foods are generally addressed by USDA, rather than FDA.

    Review USDA National Organic Program

    See 7 CFR part 205

    The USDA accredits private businesses, organizations, and state agencies to certify producers and handlers of agricultural products according to the NOP regulations.

    Certification is the process where a producer or handler is approved by an Accredited Certifying Agent as being in compliance with the NOP regulations and is then authorized to sell, label, or represent products as being “certified organic”.

    Organic Labeling and Marketing Information:

    • Agricultural Products labeled as “100 percent organic” must contain (excluding water and salt) only organically produced ingredients and processing aids.  Agricultural Products labeled “organic” must consist of at least 95 percent organically produced ingredients (excluding water and salt).
    • Processed products that contain at least 70 percent organic ingredients can use the phrase “made with organic ingredients” and list up to three of the organic ingredients or food groups on the principal display panel. Processed products that contain less than 70 percent organic ingredients cannot use the term organic anywhere on the principal display panel. However, they may identify the specific ingredients that are organically produced on the ingredients statement on the information panel.
    • The information panel of any product labeled as organic must
      • identify each organically produced ingredient in the ingredient statement, and
      • provide the name and address of the certifying agent of the final product.

    The National Organic Standards Board’s main mission is to make recommendations about whether a substance should be allowed or prohibited in organic production or handling, and to assist in the development of standards for substances to be used in organic production.

    Labeling Organic Products according to The National Organic Program

    • Labeling Packaged Products-- USDA AMS web page
      • "These requirements do not preempt Food and Drug Administration; USDA, Food Safety and Inspection Service; or the Bureau of Alcohol, Tobacco and Firemans labeling regulations or label approval requirements."
      • Note the categories of "100 percent Organic," "Organic" and "Made with Organic Ingredients."
      • Regulations -- 7 CFR part 205, sections 205.308, 205.309, 205.605, & 205.606.
      • Labeling and Marketing Information -- USDA AMS web page

     

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    U.S. Regulation of Biotechnology/GMO

     

    "Responsibility for implementing the coordinated framework fell primarily to three agencies: USDA, the Environmental Protection Agency (EPA), and FDA. Within USDA, the Animal and Plant Health Inspection Service (APHIS) bears the main responsibility for assessing the environmental safety of GM crops. The primary focus of APHIS' review is to determine whether or not a plant produced through biotechnology has the potential to harm natural habitats or agriculture. Developers can petition APHIS to exempt a GM plant from regulation once sufficient and appropriate data have been collected regarding the potential environmental impact of a GM plant.

    APHIS' Role in Biotechnology (USDA)

    "APHIS regulates the introduction (importation, interstate movement, or environmental release) of certain genetically engineered (GE) organisms. All regulated introductions of GE organisms must be authorized by APHIS under either its permitting or notification procedures.

    "When a developer has collected enough evidence that a GE organism poses no more of a plant pest risk than an equivalent non-GE organism, the developer may petition APHIS to grant the GE organism non-regulated status. If the petition is approved by APHIS, the GE organism may then be introduced into the United States without any further APHIS regulatory oversight."  excerpt from Permits, Notifications, and Petitions

    "To safeguard the environment and human health, EPA is responsible for regulating genetic modifications in plants that protect them from insects, bacteria, and viruses. These protectants are subject to the agency's regulations on the sale, distribution, and use of pesticides. EPA must review and grant a permit for field-testing plants with such protectants on more than 10 acres of land. Prior to commercialization of a GM plant with such a protectant, EPA reviews the application for approval of the protectant, solicits public comments, and may seek the counsel of external scientific experts.

    Biotechnology (EPA)

    Also see Microbial Products of Biotechnology: Final Regulations Under the Toxic Substances Control Act Summary

    "FDA has primary authority for the safety of most of the food supply. The Federal Food, Drug, and Cosmetic Act establishes the standard for food safety as food being in an unadulterated condition. FDA established its basic policy regarding the review of GM foods in its 1992 Policy on Foods Derived from New Plant Varieties. According to this policy, FDA relies on companies developing GM foods to voluntarily notify the agency before marketing the foods. Notification leads to a two-part consultation process between the agency and the company that initially involves discussions of relevant safety issues and subsequently the company's submission of a safety assessment report containing test data on the food in question. At the end of the consultation, FDA evaluates the data and may send a letter to the company stating that the agency has no further questions, indicating in effect that it sees no reason to prevent the company from marketing the GM food. In 1997, FDA supplemented its 1992 Policy with the current Guidance on Consultation Procedures, clarifying procedures for the initial and final consultations.

    Plant Biotechnology for Food and Feed (FDA)

    "It is the responsibility of the producer of a new food to evaluate the safety of the food and assure that the safety requirement of section 402(a)(1) of the act is met."

    "In regulating foods and their byproducts derived from new plant varieties, FDA intends to use its food additive authority to the extent necessary to protect public health. Specifically, consistent with the statutory definition of "food additive" and the overall design of FDA's current food safety regulatory program, FDA will use section 409 of the act to require food additive petitions in cases where safety questions exist sufficient to warrant formal premarket review by FDA to ensure public health protection."

    "... the agency does not believe that the method of development of a new plant variety (including the use of new techniques including recombinant DNA techniques) is normally material information within the meaning of 21 U.S.C. 321(n) and would not usually be required to be disclosed in labeling for the food."

    Guidance to Industry for Foods Derived from New Plant Varieties

    "In January 2001, FDA issued a proposed rule in the Federal Register that provides further information on these procedures and, more importantly, would require pre-market notification by companies. Among the reasons that FDA cited for this change are concerns expressed by consumers and public interest groups about the limited transparency and voluntary nature of the current process. FDA also pointed to the growing power of biotechnology to create potentially more complex safety issues that could require more stringent regulatory evaluations. FDA, tentatively, expects to finalize this rule as early as fiscal year 2003."

    Excerpt from GENETICALLY MODIFIED FOODS Experts View Regimen of Safety Tests as Adequate, but FDA's Evaluation Process Could Be Enhanced

     

     

    International response to GMOs in food

    November 2014 link:  FDA's "Biotechnology -- Genetically Engineered Plants for Food & Feed" at http://www.fda.gov/Food/FoodScienceResearch/Biotechnology/default.htm; also see USDA APHIS' "Biotechnology (BRS)" at  http://www.aphis.usda.gov/wps/portal/aphis/ourfocus/biotechnology; EPA's "Regulating Biopesticides" at http://www.epa.gov/pesticides/biopesticides/; and EPA's "Microbial Products of Biotechnology Summary of Regulations under the Toxic Substances Control Act" at http://www.epa.gov/oppt/biotech/pubs/fs-001.htm.

    EPA states:"Unified Biotechnology Website has been decommissioned"; see http://usbiotechreg.epa.gov/

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    Summary of Key Points

    • U.S. food law has a long history of evolving as new issues and concerns lead to political reaction.  This has certainly been the trend for U.S. federal food law.  This page introduced several U.S. federal food laws that address specific foods. Each of these laws has a history of events that caught national or international attention in the past 50 years.  Persons involved in the food industry need to recognize the application of the general or encompassing food laws may be altered by additional or divergent legal requirements for specific foods.

     

     

      Email David.Saxowsky@ndsu.edu

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