ILAR Journal Online, Volume 37(2) 1995: Laboratory Animal Care Policies and Regulations

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ILAR Journal V37(2) 1995
Laboratory Animal Care Policies and Regulations

Emerging Issues

The Impact of International Free Trade Agreements on Animal Research
James W. Glosser

James W. Glosser, Ph.D., is a former administrator of the Animal and Plant Health Inspection Service, U.S. Department of Agriculture.

The creation of a global common market will require major changes in public policies and initiatives concerning international trade on the part of all countries. Such a market will also require more scientific information to optimally identify and manage risks. A common market will allow the free movement of goods, persons, services, and capital among countries with diverse socioeconomic situations, cultural backgrounds, and regulatory systems. It represents a marked shift away from the traditional policy of refusing animal and plant trade from regions with any degree of health risk (such as pests and diseases) towards assessing the level of risk that would permit safe trade. The U.S. Congress ratified the North American Free Trade Agreement (NAFTA) in November 1993, and the Uruguay Round of the General Agreement for Tariffs and Trade (GATT) in December 1994. Both agreements aim to reduce and eliminate barriers to trade, investment, and services, and they clearly signal the emergence of a "one world" global market.

These agreements introduce a host of questions for the scientific community: What are their implications for biomedical research? Will new trade policies and initiatives affect research priorities in the future? How will research and development of new techniques and assay methods be impacted: Will additional restraints in the form of new guidelines and regulations be forthcoming?

A new world market will, without question, present challenges as well as new opportunities for the scientific community. Therefore, it is important for the researcher to become familiar with the general provisions of NAFTA and GATT in order to identify concerns, participate in discussions, and assume an appropriate role in developing new policy.

At present, Canada, Mexico, and the United States constitute NAFTA. With 360 million people and a gross national product totaling $6 trillion, this agreement creates the largest free-trade area in the world. In the future, it is quite likely that more countries will be added. For example, Chile is preparing to meet the NAFTA provisions, and preliminary discussions are ongoing with some Central American countries. A bill to include the Caribbean countries in NAFTA was recently introduced in Congress. The GATT comprises 115 signatory countries and has provisions similar to NAFTA.

In addition to eliminating traditional barriers such as quotas and tariffs, both agreements have sanitary and phyto-sanitary (S&P) provisions intended to control the use of nontariff trade barriers such as unjustified technical animal and plant health standards. Key provisions of both agreements include (1) the use of science-based measures (such as risk assessment); (2) recognition of pest-free, disease-free, and low-prevalence areas, thus allowing trade from those areas; (3) participation in the international standard-setting organizations, and wherever possible, basing import requirements on international standards; (4) recognition of equivalent treatments and quarantine practices to facilitate trade (known as "equivalence"); (5) provision by member countries of advance notification of any new or modified regulation or policy that may affect trade (known as "transparency"); and (6) establishment of a dispute settlement process that begins with a consultation of technical representatives from both parties and proceeds, if necessary, to the use of a formal dispute settlement system (NAFTA, Volume 1, Chapter 7, Section B, Articles 709-724; GATT, Uruguay Round of Agreements, Articles XXII, XX(b), XXIII).

The requirement of science-based measures in determining import policy is significant because it means that import decisions must be based on a risk assessment. In other words, scientific data and methodologies must be used. Both agreements require that key factors be considered in determining science-based measures for import policy, which include (1) risk assessment methodologies and techniques developed by the Office of International Epizootics (OIE) for animals and the International Plant Protection Convention (IPPC) for plants; (2) relevant scientific evidence; (3) relevant processes and production methods; (4) relevant inspection, sampling, and testing methods; (5) prevalence of disease or pests; (6) relevant ecological and environmental conditions; (7) relevant treatments, including quarantines; and (8) relevant economic factors such as production or sales losses and the control of costs if a particular disease or pest were introduced (NAFTA, Volume 1, Chapter 7, Section B, Articles 709-724; GATT, Uruguay Round of Agreements, Articles XXII, XX(b), XXIII).

A major challenge in both agreements is to develop an acceptable approach to resolving disputes that involve diverse regulatory systems or trade measures. The solution lies in harmonization with the broadest possible use of international standards and the creation of a workable dispute settlement system.

Both agreements stress that the first step in handling disputes is a technical consultation. If there is no resolution of the problem at that level, the plaintiff country can elevate its complaint by evoking the formal dispute settlement process. Panels will be formed to review complaints and make recommendations. The panels may seek recommendations and advice from an international standard-setting organization (such as OIE and IPPC), as well as from a board of experts to evaluate the issue. Advisory panels will determine whether the disputed measure is based on a scientific risk assessment and whether the data and the process used in the assessment was ( 1 ) collected in a scientific manner, (2) based on international standards if such standards exist, (3) not discriminatory, and (4) transparent. Prior to NAFTA and GATT, countries entered bilateral negotiations to solve disputes, such as the latest Halifax summit meeting when the president of the United States and prime minister of Japan discussed the threat of 100 percent tariff penalties on a half dozen Japanese car imports.

Although some international animal standards are in place, they are far from being complete. Hopefully, future standards will be adopted from high quality past and existing management practices. Standards for animal welfare and biotechnology are currently nonexistent within the framework of NAFTA and GATT, and considerable discussion and negotiation will be required to harmonize approaches. The current S&P codes do not address the use of animal welfare or other socioeconomic measures as barriers to trade, such as the uncertain status of bovine somatotropin and the total ban of anabolic growth promoters in the European market.

Standardized animal welfare regulations may become even more important in international trade, because one of the major aspects to be considered in a risk assessment is the relevant process and production methods used in a product. Presently, products are assessed on the end product and not on the process by which it is produced. If agreement is reached on principles for regulating commodities according to how they are processed, restrictions potentially could be imposed on veal, pork, and poultry because of the breeding and husbandry practices used to raise those animals.

Animal welfare is an increasingly important issue in the field of biotechnology, particularly regarding recombinant DNA products and transgenic animals. Beyond achieving scientific consensus on safety, efficacy, and quality, genetically engineered products and animals will in all probability be subjected to intense public scrutiny, also known as the "fourth hurdle." Public debates about transgenic animals are similar to those involving the hormone ban and the current moratorium on the licensure and use of bovine somatotropin. Without question, this issue will continue to be a daunting challenge to the research community.

Because of the considerable variation among animal welfare laws and regulations of different countries and regions, it is possible that a country could take an animal welfare issue and turn it into a health issue. European countries have already developed and implemented formal policies concerning the protection and care of animals used for scientific and farming purposes. For example, the Treaty of the European Union (EU) includes a declaration that requires the European Parliament and its subunits (the Council, Commission, as well as member states) to comply with the welfare requirements of animals when drafting and implementing legislation. In addition, there are currently three overriding legal documents at the EU level, which deal specifically with animal biotechnology. These are (1) Council Directive 86/609/ EEC, November 24, 1986 dealing with the laws, regulations, and administrative provision of the member states regarding the protection of animals used for experimental and scientific study; (2) Council Directive 90/220/EEC, April 23, 1990 dealing with the deliberate release of genetically modified organisms in the environment; and (3) the European Convention for the Protection of Animals kept for farming purposes, to which the EU is also a contracting party. In contrast, U.S. animal welfare laws regulate the care and use of animals used in biomedical research, but exempt farm animals.

Clearly there is a need to develop international standards for animal welfare to prevent the issue from becoming a nontariff trade barrier as the movement of laboratory animals will only increase between countries with different levels of sophistication and infrastructure regarding the care and welfare of animals. An excellent resource and starting point for developing such international standards for animal welfare is the Guide for the Care and Use of Laboratory Animals (NRC, 1985).

Developing international standards is of prime importance to make trade as free as possible by providing acceptable levels of risk. Scientific advice will be vital in providing negotiators with information on which to forge those standards. The results will be critical for human health, pharmaceuticals, trade of animals, and animal welfare. The trade agreements provide an excellent opportunity for the research community, especially individual scientists, to assist in developing technically sound and operationally feasible standard approaches for conducting risk assessment.

Scientists have other opportunities for input. These include (1) participating as key players in discussions to clarify and define levels of risk, (2) standing ready to serve on expert panels to review disputes and provide findings and recommendations, and (3) focusing on research that provides new technologies and assay methods to reduce animal health risks to levels that permit safe trade.

In summary, researchers should seize the opportunity to assist in developing new policies and initiatives during the implementation phase of the dramatic changes in policy brought about by free trade in a global market. The participation of the research community is needed to optimize international scientific exchange of views on how to facilitate the movement of animals, animal products, cell lines, cell products, pharmaceuticals, and agricultural products.

REFERENCES

National Research Council (NRC). 1985. Guide for the Care and Use of Laboratory Animals. Washington, D.C.: U.S. Department of Health and Human Services. NIH Pub. No. 86-23. (Available from Office for Protection from Research Risks, National Institutes of Health, 6100 Executive Boulevard, MSC 7507, Rockville, MD 20892-7507. Tel: 301-496-7163)