"The International Plant Protection Convention (IPPC) is an international treaty whose purpose is to secure a common and effective action to prevent the spread and introduction of pests of plants and plant products, and to promote appropriate measures for their control."

EU signs up to new international rules  Brussels, 20 July 2004

"The [EU] Agriculture Council has approved a revision of the International Plant Protection Convention (IPPC) to strengthen its role in setting international standards. Council also decided that the European Union should become a party to the IPPC in its own right, alongside the 25 EU Member States. Both decisions recognise the growing importance of the IPPC in the international trading system. The World Trade Organisation (WTO) recognises the right of WTO members to impose restrictions on imports if these are needed to protect their agriculture from plant diseases or pests. This right is set out in the WTO's Agreement on Sanitary and Phytosanitary measures (SPS Agreement), which also calls on the IPPC to provide international standards to help ensure WTO members develop a harmonised approach and do not use such measures as unjustified barriers to trade. The revised Convention formalises the IPPC's Secretariat and establishes a governing body, the "Commission on Phytosanitary Measures", for the setting of International Standards for Phytosanitary Measures. These will be recognised under the SPS Agreement. The standard-setting process in the IPPC emphasises participation, consultation and technical competence. The new rules explicitly foresee the participation of bodies such as the EU."

Back to food:

The Codex standards for food are set by committees comprised of representaives from member nations.

"General Subject Committees are so called because their work has relevance for all Commodity Committees and, since this work applies across the board to all commodity standards, General Subject Committees are sometimes referred to as "horizontal committees". There are nine such committees:"

"Commodity Committees have responsibility for developing standards for specific foods or classes of food. In order to distinguish them from the "horizontal committees" and recognize their exclusive responsibilities, they are often referred to as "vertical" committees. There are 16 such committees:"

Excerpt fromThe Codex system: FAO, WHO and the Codex Alimentarius Commission

Process for setting standards

"The Procedure for the Elaboration of Codex Standards describes the way by which Codex standards are prepared and the various Steps in the process which ensure comprehensive review of draft standards by governments and other interested parties. It was comprehensively revised in 1993 to provide a uniform elaboration procedure for all Codex standards and related texts. The Procedure allows the use of a “fast-track” approach in cases where urgent action is needed."

Excerpt from Codex Alimentarius Commission - Procedural Manual, p.4 of pdf file.

The standards should not be used as barriers to trade

"Under the WTO agreements, countries cannot normally discriminate between their trading partners... Imported and locally-produced goods should be treated equally"

Excerpts from UNDERSTANDING THE WTO: BASICS Principles of the trading system

WTO's objective of trade neutrality is consistent with Codex

"The officials and experts who laid the foundations and determined the direction taken by activities of the Joint FAO/WHO Food Standards Programme and the Codex Alimentarius Commission were first and foremost concerned with protecting the health of consumers and ensuring fair practices in the food trade. They felt that, if all countries harmonized their food laws and adopted internationally agreed standards, such issues would be dealt with naturally. Through harmonization, they envisaged fewer barriers to trade and a freer movement of among countries, which would be to the benefit of farmers and their families and would also help to reduce hunger and poverty."

Taken from Codex and the international food trade

But there are exceptions; one is national health concerns

"Article 20 of the General Agreement on Tariffs and Trade (GATT) allows governments to act on trade in order to protect human, animal or plant life or health, provided they do not discriminate or use this as disguised protectionism. In addition, there are two specific WTO agreements dealing with food safety and animal and plant health and safety, and with product standards." 

"Member countries are encouraged to use international standards, guidelines and recommendations where they exist. However, members may use measures which result in higher standards if there is scientific justification. They can also set higher standards based on appropriate assessment of risks so long as the approach is consistent, not arbitrary."

Taken from UNDERSTANDING THE WTO: THE AGREEMENTS Standards and safety

Regional approach to distinct needs and concerns

Consistent with the idea that some areas have distinct needs, Codex encourages that distinct needs be identified and addressed by nations in the region, rather than individual nations. The hope is that a regional approach should lead to fewer issues than if distinct standards are established by individual nations.  However, a regional approach does not prohibit individual nations from addresses their needs.

"The [Codex Regional] Coordinating Committee[s are] responsible for defining problems and needs concerning food standards and food control of all Codex member countries of the region."

See The Codex system: FAO, WHO and the Codex Alimentarius Commission (FAO)

Regionalism: friends or rivals? (WTO)

Regional Coordinating Committees (FSIS)

Information about food safety for selected nations

• Canada - Canadian Food Inspection Agency http://www.inspection.gc.ca/english/toce.shtml

"The CFIA delivers 14 inspection programs related to foods, plants and animals in 18 regions across Canada. Our role is to enforce the food safety and nutritional quality standards established by Health Canada and, for animal health and plant protection, to set standards and carry out enforcement and inspection."

Excerpt from The Canadian Food Inspection Agency: Contributing to the Quality of Canadian Life

• Norway -- Norwegian Food Safety Authority

http://www.mattilsynet.no/portal/page?_pageid=34,33401&_dad=portal92&_schema=PORTAL92

"The Norwegian Food Safety Authority has three administrative levels. The head office is located is Oslo. There are eight regional offices and 64 district offices. The Norwegian Food Safety Authority has 1,300 employees. The 64 district offices carry out practically all of the active inspections. Having offices throughout the country means that the Norwegian Food Safety Authority is close to both consumers and the relevant businesses."

• United Kingdom -- Food Standards Agency http://www.foodstandards.gov.uk/

"The Food Standards Agency is an independent food safety watchdog set up by an Act of Parliament in 2000 to protect the public's health and consumer interests in relation to food."

• Australia and New Zealand -- Food Standards Australia New Zealand http://www.foodstandards.gov.au/

"Food Standards Australia New Zealand ensures safe food by developing effective food standards for Australia and New Zealand. We are an integral part of a strong food regulatory system operating between governments at all levels in Australia and New Zealand.  We develop food standards with advice from other government agencies, input from stakeholders and food regulatory policies endorsed by the Australia and New Zealand Food Regulation Ministerial Council.  Our decisions are open and accountable, based on the rigorous scientific assessment of any risk to public health and safety.  In Australia, we develop food standards for the entire food supply chain, from primary production through to manufactured food and retail outlets."

• European Union -- Food Safety from the Farm to the Fork http://europa.eu.int/comm/food/index_en.htm

   

• Japan -- General Food Policy Bureau http://www.syokuryo.maff.go.jp/

• Morocco -- Contrôle de Qualité; MINISTERE DE L'AGRICULTURE ET DU DEVELOPPEMENT RURAL

http://www.madrpm.gov.ma/accueil/grande%20cadre%20test1.htm

• International Organization for Standardization (ISO); food products

Information about US food safety

Primary US agencies involved with food safety are the Food and Drug Administration (FDA), Food Safety and Inspection Service (FSIS) of the USDA, and Environmental Protection Agency (EPA).

• Center for Food Safety and Applied Nutrition, Food and Drug Administration, Department of Health and Human Services

"CFSAN, in conjunction with the Agency's field staff, is responsible for promoting and protecting the public's health by ensuring that the nation's food supply is safe, sanitary, wholesome, and honestly labeled, and that cosmetic products are safe and properly labeled."

Excerpt fromCenter for Food Safety and Applied Nutrition -- Overview

• Food Safety and Inspection Service, Department of Agriculture

"The Food Safety and Inspection Service (FSIS), a public health regulatory agency of the U.S. Department of Agriculture, protects consumers by ensuring that meat, poultry, and egg products are safe, wholesome, and accurately labeled."

Excerpt from Protecting the Public From Foodborne Illness: The Food Safety and Inspection Service

• Environmental Protection Agency

"Although the Food and Drug Administration regulates most aspects of food production and consumption in the United States, the EPA is responsible for regulating the use of pesticides on food. If improperly used, pesticides can cause serious health problems, including birth defects, nerve damage, cancer, and unique health risks to children. The EPA, in cooperation with the states, carefully regulates pesticides to ensure that their use does not compromise food safety. In particular, the Federal pesticide program is designed to ensure that pesticides can be used without posing harm to the most vulnerable members of society, children and infants."

40 CFR Part 180

FDA description of United States Food Safety System

FDA/USDA Jurisdiction Chart describes "jurisdiction overlap for commerical products regulated by either or both FDA and USDA."

Brief overview of FDA food regulation

Basic US law is that adulterated and misbranded foods are prohibited.  These prohibitions are broadly defined.  Corollary to these prohibitions are mandatory and volunatry steps to assure food is not adulterated or misbranded.

"The six-page Wiley law [the 1906 Food and Drug Act] prohibited the manufacture and interstate shipment of "adulterated" and "misbranded" foods and drugs."

Excerpt from The Story Of The Laws Behind The Labels

Key points about US laws regulating food safety; note that FDA has primary responsibilities for most food products but FSIS has primary responsibility for meat, poultry and egg products.  The following information emphasizes FDA's authorities and responsbilities, but information about FSIS has also been included for some of the topics.

• FDA established food standards

see 21 CFR parts 130 to 169

Agricultural Marketing Service (USDA) is responsible for specifying standards for meat, poultry and eggs standards e.g., 7 CFR parts 53, 54, and 58

• FDA addresses food additives, which includes identifying "Generally Recognized as Safe" (GRAS) food additives.

"A substance that will be added to food is subject to premarket approval by FDA unless its use is generally recognized as safe (GRAS)"

Taken from GRAS Notification Program;21 CFR parts 182 to 186

• FDA addresses indirect food additives (21 CFR parts 174 to 178);FDA regulates food contact substances; that is, "any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have any technical effect in such food."  See Inventory of Effective Premarket Notifications for Food Contact Substances
• FDA specfies substances prohibited from being added to food (21 CFR part 189).

DeLaney clause

• FDA regulates color additives by permitting only certified substances to be used to color food.

COLOR ADDITIVES FACT SHEET "Only approved substances may be used to color foods..."

Certification process is used to implement the approval process 21 CFR parts 70 to 82

• Food establishments must register with the FDA

"Domestic and foreign facilities that manufacture, process, pack, or hold food, as defined in the regulation, for human or animal consumption in the U.S. must register with FDA by December 12, 2003."

Registration of Food Facilities

• FDA is authorized to inspect food establishments

"Section 704 of the Food, Drug & Cosmetic Act [21 U.S.C. 374] provides the basic authority for establishment inspections. This authorizes [FDA personnel] to enter, and to inspect at reasonable times, within reasonable limits, and in a reasonable manner, establishments or vehicles being used to process, hold or transport food, drugs, devices or cosmetics. The statute does not define, in specific terms, the meaning of "reasonable". FDA's establishment inspection procedures maintain this authority extends to what is reasonably necessary to achieve the objective of the inspection."

Excerpt from Investigations Operations Manual Section 701.01

• "Under authority of the Federal Meat, Poultry and Egg Products Inspection Acts, FSIS inspects and monitors all meat, poultry and egg products sold in interstate and foreign commerce to ensure compliance with mandatory U.S. food safety standards and inspection legislation."

  Excerpt from FSIS Inspection Programs

• Meat and poultry plants (that is, those plants under the jurisdication of the FSIS) cannot operate without a federal inspector (or federally-approved state inspector); all other plants (that is, those plants under the jurisdiction of FDA) are not required to have a federal inspector in order to operate, but (as mentioned above) an inspection can be conducted at any time during normal operations.  FSIS inspections include an inspection of live animal and the resulting meat product.

• Food establisments are required to follow good manufacturing practices.

"Current Good Manufacturing Practice (CGMP) regulations for foods ... are printed in Title 21 Code of Federal Regulations, Part 110 (21 CFR 110)."

• These regulations address personnel, plant and grounds, sanitary operations, sanitary facilities and controls, equipment and utensils, processes and controls, and Warehousing and distribution.
• These regulations are not limited to situations that cause contamination, but also encompass conditions that "may cause" contamination even though the condition does not cause contamination.  See 21 CFR 110.5.
• FSIS (which is responsible for meat, poultry and eggs) has an inspector in the food establishment during all hours of operation and inspects the product; for example, in a livestock processing facility, the animal is inspected by a goverment inspector before slaughter and the product is inspected after slaughter.

• Alternative to specifying CGMP is to require food establishments to develop Hazardous Analysis and Critical Control Points (HACCP) plans.
  • FDA:  HACCP: A State-of-the-Art Approach to Food Safety

  Also see (21 CFR part 120)

  FDA:  Seafood HACCP and Juice HACCP

• FSIS:  HACCP for meat and poultry plants (9 CFR part 417)

FSIS:  THE HACCP BASED INSPECTION MODELS PROJECT

FSIS: Guidebook for the Preparation of HACCP Plans and Generic HACCP Models

• FDA addresses food packaging and labeling

"A container that does not allow the consumer to fully view its contents shall be considered to be filled as to be misleading if it contains nonfunctional slack-fill." 21 CFR 100.100

"A substance used in a food-contact article (e.g., food-packaging or food-processing equipment) that migrates, or that may be expected to migrate, into food will be exempted from regulation as a food additive because it becomes a component of food at levels that are below the threshold of regulation if: ..." 21 CFR 170.39

"Food labeling is required for most prepared foods, such as breads, cereals, canned and frozen foods, snacks, desserts, drinks, etc. Nutrition labeling for raw produce (fruits and vegetables) and fish is voluntary...[D]ietary supplements ... ha[ve] separate labeling requirements"

Taken from Food Labeling and Nutrition -- Overvew

Also see A Food Labeling Guide and Information for Industry

Also see 21CFR Part 101

• FDA monitors certain foods more closely than others

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

"Low-acid canned foods (LACF) and acidified foods (AF) in hermetically sealed containers are [regulated] 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 Requirements for ... Low-Acid Canned Foods and Acidified Foods

21 CFR Parts 113 and 114

... Manufacture and Distribution of Infant Formula

"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."

21 CFR Parts 106 and 107

Overview of Dietary Supplements

"... 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."

21 CFR Part 190

The Food and Drug Administration's Seafood Regulatory Program also role of National Marine Fisheries Service (NOAA Fisheries)

"The FDA operates an oversight compliance program for fishery products under which responsibility for the product's safety, wholesomeness, identity and economic integrity rests with the processor or importer, who must comply with regulations promulgated under the Federal Food, Drug and Cosmetic (FD&C) Act, as amended, and the Fair Packaging and Labeling Act (FPLA). In addition, FDA operates the Low-Acid Canned Food (LACF) program which is based on the Hazard Analysis Critical Control Point (HACCP) concept, and is focused on thermally processed, commercially sterile foods, including seafood such as canned tuna and salmon. Most FDA in-plant inspections consider product safety, plant/food hygiene and economic fraud issues..."

21 CFR Part 123 (includes HACCP requirement for FISH AND FISHERY PRODUCTS)

Other Special Categories

The National Organic Program administered by the Agricultural Marketing Service (AMS) of the 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."  Taken from http://www.ams.usda.gov/nop/NOP/standards/Intro.html

• 7 U.S.C. 6501 et. seq.
• 7 CFR part 205
• Program Standards

• FDA monitors food imports and exports; this includes inspecting plants in other nations that export to the US.

FDA -- Importing Food ... into the United States

"All imported products are required to meet the same standards as domestic goods. Imported foods must be pure, wholesome, safe to eat, and produced under sanitary conditions;"

INTERNATIONAL INSPECTION PROGRAM

FDA -- Exporting Food ... from the United States

FDA-Issued/Supported Export Certificates for Foods -- Background Information

FSIS -- Import Information for meat, poultry and egg products

Importing Meat, Poultry & Egg Products to the United States

Evaluating the Equivalence of Foreign Meat and Poultry Food Regulatory Systems

FSIS -- Export Information for meat, poultry and egg products

Certifying Meat & Poultry Products for Export

CERTIFICATION OF DAIRY PRODUCTS INTENDED FOR EXPORT TO THE EUROPEAN UNION

"As of December 12, 2003, FDA must be notified in advance of any shipments of food for humans and other animals that are imported into the U.S., unless the food is excluded from Prior Notice."  See Notice of imports

• Records of shipments and traceability

Maintain records of all food transported in interstate commerce.

Recent developments due to terrorism concerns, but also begins to address traceability

"[edited] Domestic persons that manufacture, process, pack, transport, distribute, receive, hold or import food intended for human or animal consumption in the U. S. (excluding farms and restaurants) and foreign facilities that manufacture, process, pack or hold food intended for human or animal consumption in the U. S. must maintain for not longer than two years records needed by 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." See Establishment and Maintenance of Records

• FDA is required to participate in the multi-agency task of assuring a secure food supply (e.g., protect against bioterrorism threat); strategies to achieve this objective inlcude food establishment registration, import notice, and traceability.  Each of these topics has already been mentioned.

• FDA's enforcement of food safety laws
  • Recalls -- "A food recall is a voluntary action by a manufacturer or distributor to protect the public from products that may cause health problems or possible death."
  • FDA GUIDANCE FOR INDUSTRY Product Recalls, Including Removals and Corrections
  • FDA Recall Policies

• FSIS Recalls; FSIS Recall Process
• Enforcement other than recall
  • FSIS can remove inspectors from processing plant that is in violation of any food safety law; this effective stops the legal operation of the plant.

• Consumer education
  • A basic premise of US food law is that consumers are responsible for deciding which food product to consume.  To facilitate this approach, government agencies will work with firms to eliminate adulterated food and assure that the food is properly labelled.  The assumption is that the consumer can then use the label information in deciding whether to purchase the item.  However, consumers need to be able to interpret and apply the information in their decision making process.  Consumers also need to know how to prepare their food to minimize the risk of a safety problem.  Accordingly, consumer education is an important aspect of the US overall food safety strategy.
  • FDA -- Consumer Advice on Food Safety, Nutrition, and Cosmetics
  • Food and Nutrition Service and Center for Nutrition Policy and Promotion (USDA)

• FDA collaborates with other US federal agencies

  Food Safety: A Team Approach

  • FoodNet -- Centers of Disease Control and Prevention

  "FoodNet is a collaborative project ... consist[ing] of active surveillance for foodborne diseases and related epidemiologic studies designed to help public health officials better understand the epidemiology of foodborne diseases in the United States."

  see also Foodborne Diseases Active Surveillance Network (FoodNet)

  • advertising and claims - Federal Trade Commission
  • imports and exports -- US Customs Service
  • pesticide tolerances -- Environmental Protection Agency

• FDAcollaborates with US state agencies (e.g., memorandums of understanding, recalls, Food Code)

  Federal/State Food Programs

• FDA collaborates with agencies of other nations (international issues, again)
  • FDA  International Harmonization
  • FDA Equivalence Evaluations (links to FDA's Affirmative Agenda for International Activities)
  • FSIS  "The U.S. Codex Office, located in FSIS, USDA, is the U.S. Contact Point for the Codex Alimentarius Commission and its activities."

Biotechnology and genetically modified products

The regulation of biotechnology blurs the distinction between the production stage and processing stage of the food industry.  Some would say the GMOs pose a food safety issue (assuming there is a potential problem with GMO products); others would say that GMOs are not a food safety issue because they do not pose a health or safety concern.  We will not resolve that issue at this time; but like those involved in the debate, we will consider what these groups are describing as a current strategy for addressing biotechnology.  This strategy includes labeling GMO food and taking steps to assure traceablity.  However, these steps have been used, are being used, and will likely continue to be used to address other food safety issues.  For this reason, taking these steps to to address concerns about GMO food is not novel.

• US 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.

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.

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.

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

Introduction to Biotechnology Regulatory Services of the Animal & Plant Health Inspection Service

United States Regulatory Agencies Unified Biotechnology Website

• International response to GMOs in food

FAO/WHO FOOD SAFETY ASSESSMENTS OF FOODS DERIVED FROM BIOTECHNOLOGY

FAO Statement on Biotechnology

EUROPA Biotechnology - Introduction

EUROPA GM Food & Feed - Labelling