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U.S. Department of Health and Human Services

Animal & Veterinary

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CVM Participation in Codex Alimentarius: Important for Food Safety as Well as for International Trade

by Merton Smith, Ph.D., J.D., Special Assistant for International Activities, Center for Veterinary Medicine
FDA Veterinarian Newsletter November/December 2005 Volume XX, No VI

An important part of the regulatory work of the Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) relates to the establishment of, and monitoring compliance with, appropriate food safety measures. Many of CVM’s food safety controls are based on or are complementary to standards developed by the Codex Alimentarius Commission (CAC) http://www.codexalimentarius.net.disclaimer icon

The CAC is an international body created to establish food standards with the dual goals of protecting the health of consumers and ensuring fair practices in the food trade. Sometimes, food standards include protective health measures that national governments use for import controls. Import regulations are often referred to as “non-tariff barriers” because they can function in a similar manner as tariffs to restrict trade. Non-tariff barriers may be meant to protect public health, but they can also be simply disguised barriers to trade. The standards of the CAC help prevent the use of non-tariff barriers to block trade.

The importance of the CAC as a food standards-setting organization was dramatically elevated with the April 15, 2004, signing in Marrakesh of the Final Act of the Uruguay Round of Multilateral Trade Negotiations. In addition to establishing the World Trade Organization (WTO) http://www.wto.org, the completion of the Uruguay Round included finalizing the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement). This agreement concerns the application of SPS measures—in other words, food safety and animal and plant health regulations and controls.

The SPS Agreement recognizes that governments have the right to take SPS measures, but that those measures should be applied only to the extent necessary to protect human, animal, or plant life or health and should not arbitrarily or unjustifiably discriminate between WTO member countries where identical or similar conditions prevail.

In order to harmonize SPS measures on as wide a basis as possible, WTO member countries are encouraged to base their measures on international standards, guidelines, and recommendations where they exist. One of the international standards organizations specifically named in the SPS Agreement is the CAC. (The other organizations named are the International Office of Epizootics and the International Plant Protection Convention.)

WTO member countries such as the United States can have higher standards than those established by Codex, but there must be scientific justification and the standards must reflect consistent risk decisions based on appropriate risk assessments.

The SPS Agreement spells out some basic procedures and criteria for the assessment of risk and the determination of appropriate levels of SPS protection.

It is also expected that WTO member countries will accept the SPS measures of others as equivalent if the exporting country demonstrates to the importing country that its measures achieve the importing country’s appropriate level of health protection.

In addition, the SPS Agreement includes provisions on control, inspection, and approval procedures.

Scientific evidence as basis for Codex standards

Codex relies on scientific evidence and disciplined risk assessment procedures to make its decisions in establishing food safety standards. With respect to the safety of food additives and contaminants (including residues of animal drugs), the CAC routinely considers the recommendations of the Joint Expert Committee on Food Additives (JECFA). JECFA is jointly sponsored by the World Health Organization (WHO) and the Food and Agriculture Organization (FAO).

JECFA draws its membership from standing expert advisory panels that are composed of independent scientists who serve in their individual capacities as technical experts and not as representatives of their governments or employers. The scientific caliber of WHO and FAO technical experts is outstanding. FDA and CVM toxicologists and chemists are among many of the well-qualified scientists that have served on these panels for decades.

These expert panels are convened according to the regulations governing the formation of expert advisory panels and committees of the FAO and the WHO, such as WHO’s Expert Advisory Panel on Food Safety.

In general terms, the purpose and function of JECFA include:

  • reviewing the latest knowledge and expert information on the safety of substances added to food, including food additives, residues of animal drugs in foods, and chemical contaminants in food, and making it available to FAO and WHO;
  • formulating technical recommendations; and
  • making recommendations designed to initiate, stimulate, and coordinate the research necessary to fulfill their terms of reference.

The JECFA members invited by WHO are primarily responsible for reviewing the toxicological, pharmacological, and related data and for estimating (where the data are scientifically sound) acceptable daily intakes (ADI) of substances added to food, which essentially represent the level an individual can consume over a 70-year life span without facing a significant food safety risk, and for establishing principles for toxicological evaluation and testing. The members invited by FAO are primarily responsible for preparing and reviewing the chemical specifications and analytical methodologies for the identity and purity of food additives, animal drug residues, and contaminant residues that have undergone toxicological evaluation.

When veterinary drugs are considered and the data are adequate, the JECFA members are responsible for estimating the maximum residue limits (MRLs) in foods of animal origin allowable under ADI limits when drugs are used in accordance with good practice in the use of veterinary drugs.

For veterinary drugs, the results of JECFA evaluations are forwarded to the Codex Committee on Residues of Veterinary Drugs in Foods (CCRVDF) for review and then to the CAC for acceptance.

According to the Director of CVM, Dr. Stephen F. Sundlof, the CAC is important to FDA and CVM, not only because of trade, but primarily for how it helps to assure the food safety of products consumed in the United States.

“Food products imported into the United States that meet Codex standards are less likely to present a food safety problem,” Dr. Sundlof said. “Many countries that export to the United States rely on Codex standards extensively; some countries even simply adopt Codex standards as their own. If FDA can help to assure that Codex standards are relevant, based on the best science available, and that they represent the outcome of independent, objective judgment, FDA can help improve the safety of food worldwide,” he added.

FDA officials, including Dr. Sundlof and others from CVM, have participated in Codex for many years and value this opportunity to influence the development of international food safety standards. About 10 years ago, when the WTO first went into operation and began relying on the Codex for food safety standards, CVM’s participation in the Codex became even more important, according to Dr. Sundlof.

While FDA often adopts Codex food safety standards, it is not obliged to do so if those standards do not support the level of health protection that has been deemed appropriate by Congress as reflected in relevant legislation or by FDA through its rulemaking process.

Codex Committees

The decisions of the Codex Alimentarius Committee (CAC) are the result of activities that take place in a complex organization dominated by several committees (see table below). The General Subject Committees concern themselves with issues that cut across different product commodity types. These standing committees cover “horizontal” subjects, meaning subjects that apply to several different food commodities. The subjects for these standing committees include food hygiene, food import and export inspection and certification, food labeling, food additives and contaminants, and methods of analysis and sampling. One of the general subject committees, the Codex Committee on Residues of Veterinary Drugs in Food, is chaired by Center for Veterinary Medicine (CVM) Director Dr. Stephen F. Sundlof.

The Codex also has Commodity Committees that cover “vertical” or single commodity product classes, and Regional Committees covering subjects of interest in local geographic areas of the world. These are also standing committees, but CVM usually has little or no participation in them.

The CAC also utilizes temporary, issue-driven task forces. For instance, in 2005 the CAC re-engaged its Task Force on Foods Derived from Biotechnology, which is starting to focus on an important area for CVM—foods from genetically engineered animals.

Another Codex group of great importance to CVM, the Task Force on Animal Feeding, completed its work in 2004 by publishing a Code of Good Practice on Animal Feeding. However, the CAC is considering the possibility of re-establishing this group to deal with some additional issues of relevance to animal feeding.

The CAC is also likely to approve later this year the formation of a new task force that will deal with antimicrobial resistance issues.

CODEX GENERAL SUBJECT COMMITTEES

  • General Principles
  • Food Hygiene
  • Food Import and Export Inspection and Certification Systems
  • Food Labeling
  • Food Additives and Contaminants
  • Residues of Veterinary Drugs in Foods
  • Pesticide Residues
  • Nutrition and Foods for Special Dietary Uses
  • Methods of Analysis and Sampling

CODEX COMMODITY COMMITTEES

  • Meat Hygiene
  • Milk and Milk Products
  • Fish and Fish Products
  • Processed Fruits and Vegetables
  • Fresh Fruits and Vegetables
  • Fats and Oils
  • Cocoa and Chocolate Products
  • Vegetable Proteins
  • Cereals, Pulses, and Legumes
  • Sugars
  • Natural Mineral Waters

CODEX REGIONAL COMMITTEES

  • North America and the Southwest Pacific
  • Europe
  • Asia
  • Latin American and the Caribbean
  • Africa
  • Near East
  • Middle East

CODEX TASK FORCES

  • Foods Derived from Biotechnology
  • Animal Feeding
  • Fruit and Vegetable Juices
  • Antimicrobial Resistance

ORGANIZATIONS RELATED TO CODEX

  • Joint Expert Committee on Food Additives
  • Joint Meeting on Pesticide Residues
  • Joint Expert Meetings on Microbiological Risk Assessment

OBSERVER ORGANIZATIONS INCLUDE

  • World Trade Organization
  • International Organization for Standardization
  • International Commission on Microbiological Specifications for Foods
  • Consumers International