[Federal Register Volume 60, Number 196 (Wednesday, October 11, 1995)]
[Notices]
[Pages 53078-53084]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-25070]




[[Page 53077]]

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Part III





Department of Health and Human Services





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Food and Drug Administration



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International Harmonization; Policy on Standards; Notice

  Federal Register / Vol. 60, No. 196 / Wednesday, October 11, 1995 / 
Notices  
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 94D-0300]


International Harmonization; Policy on Standards

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
agency's policy on the development and use of standards with respect to 
international harmonization of regulatory requirements and guidelines. 
Specifically, the policy is intended to address the conditions under 
which FDA plans to participate with standards bodies outside of FDA, 
domestic or international, in the development of standards applicable 
to products regulated by FDA. The policy also covers the conditions 
under which FDA intends to use the resultant standards, or other 
available domestic or international standards, in fulfilling its 
statutory mandates for safeguarding the public health.

FOR FURTHER INFORMATION CONTACT: Linda R. Horton, International Policy 
Staff (HF-23), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-3344.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of November 28, 1994 (59 FR 60870), FDA published a draft 
policy on international harmonization of regulatory requirements and 
guidelines. The purpose of the draft policy was to articulate FDA's 
policy on the development and use of standards with respect to 
international harmonization of regulatory requirements and guidelines. 
The agency gave interested persons an opportunity to comment on the 
draft policy document. A discussion of the comments received and the 
agency's responses is found in section III. of this document.
    Background information as well as the text of the policy follow:

International Harmonization of Regulatory Requirements and Guidelines

I. Background

    The purpose of this document is to articulate FDA's policy on 
development and use of standards with respect to international 
harmonization of regulatory requirements and guidelines. As used 
throughout this document, the term ``standards'' includes what are 
commonly referred to as ``consensus standards,'' ``voluntary 
standards,'' and ``industry standards.'' Also, FDA sometimes accepts 
standards and makes them mandatory regulatory requirements. Although 
the draft policy focuses on international harmonization and 
international standards, its principles are applicable as well to 
domestic standards activities in which FDA participates.

A. Statutory Mandates for FDA-Regulated Products

    FDA is the principal regulatory agency within the Public Health 
Service (PHS). The agency protects the public health by, among other 
things, implementing statutory provisions designed to ensure that 
food is safe and otherwise not adulterated or misbranded; that human 
and veterinary drugs, human biological products, and medical devices 
are safe and effective; that cosmetics are safe; and that electronic 
product radiation is properly controlled. FDA-regulated products 
must be truthfully and accurately labeled and in compliance with all 
applicable laws and regulations. The statutory mandates for 
safeguarding the public health in these product sectors are 
prescribed in several statutes, notably in the Federal Food, Drug, 
and Cosmetic Act; the Public Health Service Act; and the Fair 
Packaging and Labeling Act.

B. International Harmonization of Regulatory Requirements and 
Guidelines

    In recent decades, great changes in the world economy, together 
with expanded working relationships of regulatory agencies around 
the globe, have resulted in increased interest in international 
harmonization of regulatory requirements. Increased international 
commerce, opportunities to enhance public health through cooperative 
endeavors, and scarcity of government resources for regulation have 
resulted in efforts by the regulatory agencies of different nations 
to work together on standards and harmonize their regulatory 
requirements. Such harmonization enhances public health protection 
and improves government efficiencies by reducing both unwarranted 
contradictory regulatory requirements and redundant applications of 
similar requirements by multiple regulatory bodies. Harmonization 
facilitates cooperation in regulatory activities.
    Harmonization of FDA's regulatory requirements and guidelines 
with those of other countries was recently embraced as a pillar of 
the President's and Vice President's National Performance Review. In 
Reinventing Drug and Device Regulation (April 1995), international 
harmonization was identified as a high priority initiative across 
FDA programs. Recognizing the considerable synergy between its 
domestic policy and its international policy priorities, FDA is 
sharpening and focusing its planning for enhanced alignment of FDA 
and international standards.
    In 1992, an FDA Task Force on International Harmonization had 
provided a broad assessment of the goals, scope, and direction of 
FDA's international activities. These activities were found to 
comprise a wide variety of efforts by FDA to retain and strengthen 
its public health safeguards, while striving toward common ground 
with its foreign government counterparts on product standards, 
criteria for the assessment of test data, and enforcement 
procedures. The task force's recommendations for the agency included 
an overall FDA policy on international harmonization, which is to 
encourage the initiation and support of efforts, consistent with the 
agency's goals and principles, that will further the international 
harmonization of standards and policies for the regulation of 
products for which FDA has authority. Soon thereafter, FDA's 
strategic plan began to recognize standards as the premier focus of 
the agency's international activities.

1. Goals

    FDA's goals in participating in international harmonization are:
     To safeguard U.S. public health,
     To assure that consumer protection standards and 
requirements are met,
     To facilitate the availability of safe and effective 
products,
     To develop and utilize product standards and other 
requirements more effectively, and
     To minimize or eliminate inconsistent standards 
internationally.

2. General Principles

    FDA participation in international harmonization efforts should 
be guided by the following general principles:
     The harmonization activity should be consistent with 
U.S. Government policies and procedures and should promote U.S. 
interests with foreign countries.
     The harmonization activity should further FDA's mission 
to protect the public health by, among other things, ensuring that 
food is safe and otherwise not adulterated or misbranded; that human 
and veterinary drugs, human biological products, and medical devices 
are safe and effective as required by law and are not adulterated or 
misbranded; that cosmetics are not adulterated or misbranded; that 
electronic product radiation is properly controlled; and that all of 
these products are labeled truthfully and informatively.
     FDA's input into international standard setting 
activities should be open to public scrutiny and should provide the 
opportunity for the consideration of views of all parties concerned.
     FDA should accept, where legally permissible, the 
equivalent standards, compliance activities, and enforcement 
programs of other countries, provided that FDA is satisfied such 
standards, activities, and programs meet FDA's level of public 
health protection.
     Scientific and regulatory information and knowledge 
should be exchanged with foreign government officials, to the extent 
possible within legal constraints, to expedite the approval of 
products and protect public health.
    Thus, the agency's primary goal in all of its international 
harmonization activities is to preserve and enhance its ability to 
accomplish its public health mission. Global harmonization is also 
approached with the aim of enhancing regulatory effectiveness, by 
providing more consumer protection with scarce government resources, 
and increasing worldwide consumer access to safe, effective, and 
high quality products. 

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C. Other Obligations and Policies

1. International Agreements

    The U.S. Government is a party to international trade 
agreements. In the United States, such trade agreements become 
effective only after implementing legislation is signed into law. 
FDA has participated in recent international trade negotiations to 
ensure that FDA's requirements are preserved and that regulatory 
practices can remain focused on fulfilling the agency's mission to 
protect the public health while being supportive of emerging, 
broader U.S. Government obligations and policies. In addition, FDA 
continues to be involved in work of the World Trade Organization 
(WTO) as well as the North American Free Trade Agreement (NAFTA) 
committees on sanitary and phytosanitary measures, and on technical 
barriers to trade, in order to foster international harmonization of 
regulatory requirements and to facilitate consultation on trade 
issues. Recently FDA has begun to be involved in other regional 
activities, e.g., the Forum on Asia Pacific Economic Cooperation 
(APEC), work on initial steps toward a Free Trade Area of the 
Americas (FTAA), and work towards a Transatlantic Area that 
strengthens our ties with Europe.
    The principal international trade agreement is the General 
Agreement on Tariffs and Trade (GATT), which entered into force on 
January 1, 1948. GATT has since been amended several times following 
negotiation sessions known as rounds.
    The GATT Agreement on Technical Barriers to Trade (TBT), 
popularly known as the Standards Code, was negotiated during the 
Tokyo Round of the GATT in the 1970's and entered into force on 
January 1, 1980. As part of a general effort to reduce unnecessary 
nontariff barriers to trade, the TBT agreement was intended to 
promote use by countries of standards, technical regulations, and 
conformity assessment procedures that are based on work done by 
international standards bodies. The implementing legislation for the 
TBT agreement, provided in the Trade Agreements Act of 1979 as 
amended in 1994 (Pub. L. 103-465; 19 U.S.C 2531-2582), has thus 
provided additional authority for FDA's international standards 
activity. To assure that harmonization does not result in lowering 
safety or quality standards for U.S. consumers, this law contains 
the safeguard that:
    ``* * * No standard-related activity of any private person, 
Federal agency, or State agency shall be deemed to constitute an 
unnecessary obstacle to the foreign commerce of the United States if 
the demonstrable purpose of the standards-related activity is to 
achieve a legitimate domestic objective including, but not limited 
to, the protection of legitimate health or safety, essential 
security, environmental, or consumer interests and if such activity 
does not operate to exclude imported products which fully meet the 
objectives of such activity.''
    The most recent GATT round, the Uruguay Round, was concluded on 
December 15, 1993, and was formally signed at the Marrakech 
Ministerial Meeting on April 15, 1994. The new WTO will administer 
the new GATT and other Uruguay Round agreements, and every country 
that is a member of the WTO will be required to adhere to all of 
these agreements. On December 8, 1994, Pub. L. 103-465 was enacted 
in the United States to approve and implement the Uruguay Round 
agreements. This law included updating changes in the Trade 
Agreements Act that reaffirmed the duty of Federal agencies to 
participate in international standards activities, subject to 
available resources.
    One of the agreements of the Uruguay Round administered by the 
WTO is the new agreement on TBT, which is similar in many respects 
to the 1980 TBT agreement. As with the 1980 TBT agreement, the 
purpose of the new TBT agreement is to ensure that product 
standards, technical regulations, and related procedures do not 
create unnecessary obstacles to trade. The new TBT agreement 
ensures, and clearly states, that each country has the right to 
establish and maintain technical regulations for the protection of 
human, animal, and plant life and health and the environment, and 
for prevention against deceptive practices.
    In the new TBT agreement, the term ``standard'' is defined as:
    ``[A] document approved by a recognized body, that provides, for 
common and repeated use, rules, guidelines or characteristics for 
products or related processes and production methods, with which 
compliance is not mandatory [emphasis added]. It may also include or 
deal exclusively with terminology, symbols, packaging, marking or 
labelling requirements as they apply to a product, process or 
production method.''
    Also, ``technical regulation'' is defined as:
    ``[A] document which lays down product characteristics or their 
related processes and production methods, including applicable 
administrative provisions, with which compliance is mandatory 
[emphasis added]. It may also include or deal exclusively with 
terminology, symbols, packaging, marking, or labelling requirements 
as they apply to a product, process or production method.''
    Thus, in the language of the new TBT agreement, when a 
government acts to accept a voluntary standard to make it mandatory, 
the resulting document is a technical regulation. A measure used to 
ascertain compliance with a standard or technical regulation is a 
conformity assessment procedure.
    The new TBT agreement continues and strengthens the reference to 
international standards found in the 1980 TBT agreement. 
Specifically, the agreement states that, where technical regulations 
are required and relevant international standards exist or their 
completion is imminent, WTO-member countries shall use them, or the 
relevant parts of them, as a basis for their technical regulations, 
except when such international standards or relevant parts would be 
an ineffective or inappropriate means for the fulfillment of the 
legitimate objectives pursued. Further, the agreement states that, 
with a view towards harmonizing technical regulations on as wide a 
basis as possible, WTO-member countries shall play a full part 
within the limits of their resources in the preparation by 
appropriate international standards bodies of international 
standards for products for which they either have adopted or expect 
to adopt technical regulations.
    Another agreement of the Uruguay Round administered by the WTO 
is the Agreement on the Application of Sanitary and Phytosanitary 
Measures (SPS agreement). This agreement pertains to those measures 
intended: (1) To protect animal or plant life or health within a 
territory from risks arising from the entry, establishment, or 
spread of pests, diseases, disease-carrying organisms, or disease-
causing organisms; (2) to protect human or animal life or health 
within a territory from risks arising from additives, contaminants, 
toxins, or disease-causing organisms in foods, beverages, or 
feedstuffs; (3) to protect human life or health within a territory 
from risks arising from diseases carried by animals, plants, or 
products thereof, or from entry, establishment, or spread of pests; 
or (4) to prevent or limit other damage within a territory from the 
entry, establishment, or spread of pests.
    In order to harmonize SPS measures on as wide a basis as 
possible, the SPS agreement encourages Members to base their SPS 
measures on international standards, guidelines, or recommendations. 
Thus, the SPS agreement, like the new TBT agreement, encourages use 
of international standards. The SPS agreement refers specifically to 
standards established by the Codex Alimentarius Commission, as 
discussed below.
    NAFTA also contains TBT and SPS agreements similar to those in 
the new WTO agreements.

2. Internal U.S. Government Policy

    The United States Office of Management and Budget (OMB), in its 
revision to OMB Circular No. A-119 (58 FR 57643, October 26, 1993), 
provides policy on Federal use of standards and agency participation 
in voluntary standards bodies and standards-developing groups:
    ``It is the policy of the Federal Government in its procurement 
and regulatory activities to:
    a. Rely on voluntary standards, both domestic and international, 
whenever feasible and consistent with the law and regulation 
pursuant to law;
    b. Participate in voluntary standards bodies when such 
participation is in the public interest and is compatible with 
agencies' missions, authorities, priorities, and budget resources; 
and
    c. Coordinate agency participation in voluntary standards bodies 
so that: (1) The most effective use is made of agency resources and 
representatives; and (2) the views expressed by such representatives 
are in the public interest and, as a minimum, do not conflict with 
the interests and established views of the agencies.''
    OMB Circular No. A-119 also establishes additional policy 
guidance and responsibilities for U.S. Government agencies. It is 
applicable to all executive agency participation in voluntary 
standards activities, domestic and international, but not to 
activities carried out pursuant to treaties and international 
standardization agreements.

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    The term ``standard,'' as defined in OMB Circular No. A-119, 
means:
    ``* * * a prescribed set of rules, conditions, or requirements 
concerned with the definition of terms; classification of 
components; delineation of procedures; specification of dimensions, 
materials, performance, design, or operations; measurement of 
quality and quantity in describing materials, products, systems, 
services, or practices; or descriptions of fit and measurement of 
size.''
    The circular defines ``voluntary standards'' as:
    ``* * * established generally by private sector bodies, both 
domestic and international, and are available for use by any person 
or organization, private or governmental. The term voluntary 
standard includes what are commonly referred to as ``industry 
standards'' as well as ``consensus standards,'' but does not include 
professional standards of personal conduct, institutional codes of 
ethics, private standards of individual firms, or standards mandated 
by law, such as those contained in the United States Pharmacopeia 
and the National Formulary, as referenced in 21 U.S.C. 351.''
    These definitions in OMB Circular No. A-119 conform to common 
usage and are consistent with the usage of these terms throughout 
this policy document. It should be noted that, under the TBT, 
``standards'' are considered to be nonmandatory (i.e., voluntary) 
unless promulgated into mandatory technical regulations.

II. Standards Programs and Practices Within FDA

A. Purpose of FDA Involvement in Standards

    The central purpose of FDA involvement in the development and 
use of standards is to assist the agency in fulfilling its public 
health, regulatory mission. The agency intends to participate in the 
development of standards, domestic or international, and adopt or 
use standards when such action will enhance its ability to protect 
consumers and the effectiveness or efficiency of its regulatory 
efforts. In doing so, FDA recognizes that standards often serve as 
useful adjuncts to agency regulatory controls and that economies of 
time and human resources are often realized in solving problems when 
consensus-building activities are undertaken and conducted in open, 
public arenas. The working together of FDA staff with other 
professionals outside the agency in standards bodies effectively 
multiplies the technical resources available to FDA. Further, 
standards bodies generally have in place procedures for periodically 
reviewing and updating completed standards, thus extending the 
resource-multiplier effect, as well as keeping the solutions current 
with the state of knowledge. The economy of effort translates into 
monetary savings to the agency, regulated industries, and ultimately 
consumers. Further, using standards, especially international ones, 
is a means to facilitate the harmonization of FDA regulatory 
requirements with those of foreign governments, to better serve 
domestic and global public health.
    Another benefit of participating in the development of standards 
at both domestic and international levels is that in sharing 
technical information with technical groups and professionals 
outside FDA, staff members have opportunities to learn of other 
viewpoints on an issue, to establish scientific leadership, and to 
remain informed of state-of-the-art science and technology.

B. Past and Present Activities

    FDA has been involved in standards activities for many years, 
and on January 25, 1977, the agency promulgated a final regulation, 
now found at 21 CFR 10.95 (Sec. 10.95), covering the participation 
by FDA employees in standards-setting activities outside the agency. 
This regulation encourages FDA participation in standard-setting 
activities that are in the public interest and specifies the 
circumstances under which FDA employees can participate in various 
types of standards bodies.
    Standards activities of multilateral organizations such as the 
World Health Organization (WHO) and the Organization for Economic 
Cooperation and Development (OECD, an international organization 
with 25 member countries with advanced industrial economies) are 
often important to FDA and frequently involve multiple product 
types. For example, OECD is developing Genetic Toxicology Test 
Guidelines that are of interest to all FDA Centers. Similarly, 
guidelines developed under the International Programme on Chemical 
Safety of the WHO relate to chemicals that may be in a wide variety 
of FDA-regulated products, such as food additives, pesticides, 
drugs, animal drugs, biologics, and devices. The United States 
Pharmacopeia is a national standard setting body in which FDA 
officials actively participate.
    The principal standards organizations that are not connected 
with a treaty are the International Organization for Standardization 
(ISO) and the International Electrotechnical Commission (IEC). 
Private organizations and government agencies, including FDA, 
participate in ISO and IEC activities through the American National 
Standards Institute (ANSI). ANSI represents the United States in the 
ISO and IEC and coordinates much of the standards development 
activity in the United States. As discussed below, FDA is active in 
many ISO, IEC, ANSI, and standards development organization 
activities. For example, FDA is represented on the Board of 
Directors of ANSI and on several of its committees and working 
groups.

1. Foods and Veterinary Medicine

    FDA's Center for Food Safety and Applied Nutrition (CFSAN) and 
Center for Veterinary Medicine (CVM) actively participate in the 
development of international standards by the Codex Alimentarius 
Commission (Codex). Codex is an international organization formed in 
1962 to facilitate world trade in foods and to promote consumer 
protection. It is a subsidiary of two United Nations components, the 
Food and Agriculture Organization (FAO) and the WHO. Codex standards 
cover food commodity standards (similar to FDA standards of 
identity), food additives, food contaminants, and residues of 
veterinary drugs in food. FDA officials chair two Codex committees, 
the Food Hygiene Committee and the Residues of Veterinary Drugs in 
Foods Committee, and participate in many others. Through its 
involvement, FDA has been influential in the establishment of many 
Codex standards. FDA's procedures for reviewing Codex standards for 
purposes of regulation are codified in 21 CFR 130.6 and 564.6.
    A provision of the United States implementing legislation for 
the Uruguay Round Agreements, Pub. L. 103-465, requires the 
President to designate an agency to inform the public, through a 
notice published in the Federal Register each year by June 1, of 
certain Codex Alimentarius standard-setting activities. The 
President, pursuant to Proclamation No. 6780 of March 23, 1995 (60 
FR 15845, March 27, 1995), designated the Department of Agriculture 
to have this responsibility, and the first such notice of Codex 
activities was published in the Federal Register of May 23, 1995 (60 
FR 27250).
    In 1988, the governments of the United States and Canada entered 
into the Canada-United States Free Trade Agreement (now largely 
superseded by NAFTA). Since then, officials from CFSAN and CVM have 
participated in technical working groups responsible for 
implementation of the chapter of the agreement that deals with 
agriculture, food, beverage, and related goods (the CUSFTA Technical 
Working Groups).
    Officials from CFSAN and CVM also participate in the development 
of standards by such domestic and international groups as the Food 
Chemicals Codex (FCC), AOAC International (previously, the 
Association of Official Analytical Chemists), expert committees of 
the WHO, FAO, ISO, and other international consensus standards 
bodies. Standards developed by these organizations are used by 
industry, both in the United States and abroad. These standards 
provide industry with guidance for food grade materials and 
processes, and thus help elevate the quality of food and food 
chemicals in domestic and international trade.
    CFSAN has adopted many FCC and American Society for Testing and 
Materials (ASTM) standards and AOAC methods, incorporating them into 
regulations for both food additives and generally recognized as safe 
food ingredients. CFSAN also refers industry to relevant FCC, Codex, 
or ASTM standards when discussing particular issues related to good 
manufacturing practices. CFSAN accepts many AOAC and equivalent 
methods for use by laboratories in assaying food and in testing for 
contaminants in food.
    CVM accepts many AOAC and equivalent methods for use by 
laboratories in testing for drug residues in animal tissues. CVM has 
adopted the consumption estimates used by the FAO/WHO Joint Expert 
Committee on Food Additives in the development of standards for drug 
residues in animal tissues.
    CVM is also an active participant in a new harmonization effort 
under the auspices of the Office of International Epizooties (OIE). 
This activity is known as the International Cooperation on 
Harmonisation of Technical 

[[Page 53081]]
Requirements for Registration of Veterinary Medicinal Products (VICH).

 2. Biologics and Drugs

    There has been active international standard setting for 
biological products for more than 50 years. Officials from FDA's 
Center for Biologics Evaluation and Research (CBER) serve as experts 
or members of a variety of international committees that perform 
standard-setting functions. Activities have encompassed 
collaborative studies to establish international units of measure 
and to develop internationally accepted standards for control of 
biologics, including WHO standards. Efforts have been directed to 
many kinds of biological products, including vaccines, human blood 
and plasma products, blood testing reagents, and allergenic 
extracts, and have extended to biotechnology-derived growth factors, 
cytokines, and monoclonal antibody products.
    FDA's Center for Drug Evaluation and Research (CDER), CBER, and 
the National Center for Toxicological Research (NCTR) actively 
participate in the International Conference on Harmonisation of 
Technical Requirements for Registration of Pharmaceuticals for Human 
Use (ICH). This ongoing project, begun in 1989, has been undertaken 
by governmental agencies responsible for regulation of drugs and by 
industry trade organizations from the European Union (EU), Japan, 
and the United States. Specifically, ICH is sponsored jointly by the 
Commission of the European Communities (CEC), the Japanese Ministry 
of Health and Welfare (MHW), FDA, the European Federation of 
Pharmaceutical Industries' Associations (EFPIA), the Japan 
Pharmaceutical Manufacturers Association (JPMA), and the 
Pharmaceutical Research and Manufacturers Association (PhRMA) of the 
United States. In addition, the International Federation of 
Pharmaceutical Manufacturers Associations (IFPMA) participates as an 
umbrella organization for the pharmaceutical industry and provides 
the secretariat function for ICH. ICH operates under the direction 
of the ICH Steering Committee, which is comprised of representatives 
of these organizations. Official observer status has been given to 
WHO, the European Free Trade Area (EFTA), and the Health Protection 
Branch of Canada.
    The purposes of ICH are to: (1) Provide a forum for a dialogue 
between regulatory agencies and the pharmaceutical industry on 
differences in the technical requirements for product registration 
(i.e., requirements for product marketing) in the EU, Japan, and the 
United States; (2) identify areas where modifications in technical 
requirements or greater mutual acceptance of research and 
development procedures could lead to more efficient use of human, 
animal, and material resources without compromising safety, quality, 
and efficacy; and (3) make recommendations of practical ways to 
achieve greater harmonization in the interpretation and application 
of technical guidelines and requirements for registration. The work 
products of ICH, created in working groups of experts from the 
regulatory agencies and industry, consist of a series of consensus 
guidance documents. These guidance documents, after successive ICH 
steps of review and acceptance, including an opportunity for public 
review and comment in the respective jurisdictions, are forwarded to 
the regulatory agencies with the expectation that they will be 
formally adopted by the agencies.
    Officials from both CBER and CDER also participate in a 
consensus standard setting activity sponsored by the Council for 
International Organizations of Medical Sciences (CIOMS) that is 
aimed at standardizing medical definitions and adverse experience 
reporting.

3. Medical Devices and Radiation-Emitting Products

    FDA's Center for Devices and Radiological Health (CDRH) has had 
extensive involvement with standards in its regulation of medical 
devices, as well as electronic products that emit radiation. The 
development of standards to solve problems related to medical 
devices involves many groups outside FDA. The interaction between 
CDRH and the manufacturing and health care communities that 
frequently occurs during the standards development process provides 
knowledge and insight into the use of products, problems, and the 
effectiveness of solutions. Frequently, the public discussion of the 
problem that occurs in the consensus-building process results in the 
manufacturers and the users of the subject medical device 
implementing the solution before a standard is formally completed. 
Thus, CDRH has encouraged participation in the development of 
standards as a useful adjunct to regulatory controls. CDRH's 
approach to use and participation in the development of consensus 
standards was described in a letter dated June 29, 1993, to all 
interested parties from the Director of CDRH. (This policy did not 
apply to mandatory performance standards, i.e., technical 
regulations, for class II medical devices as specified under the 
Medical Device Amendments of 1976 (Pub. L. 94-295). The Safe Medical 
Devices Act of 1990, SMDA (Pub. L. 101-629), puts the promulgation 
of mandatory standards at the discretion of the agency.)
    Over 200 completed consensus standards and selected sections of 
additional draft standards that are not yet complete have been 
incorporated into guidance documents for applications for conducting 
clinical trials with investigational devices and applications for 
permitting devices to be marketed. These guidance documents are 
widely disseminated by CDRH to all interested parties. Other 
standards used by CDRH, or which CDRH has helped to develop, concern 
measurement or test methods, or support good manufacturing practices 
and quality assurance.
    A new ISO Committee, Technical Committee 210 (TC-210) is 
developing harmonized standards in these areas. Also, CDRH is an 
active participant in the Global Harmonization Task Force, in 
cooperation with officials from Canada, the EU, Japan, and other 
countries.
    CDRH has published a notice of a working draft of a final rule 
to revise the current good manufacturing practice regulations for 
medical devices (60 FR 37856, July 24, 1995), in part to ensure that 
they are compatible with specifications for quality systems 
contained in an international quality standard developed by ISO, 
namely ISO 9001 ``Quality Systems Part 1. Specification for Design/
Development, Production, Installation, and Servicing.'' This 
standard (ISO 9001) is becoming widely recognized by medical device 
regulatory authorities worldwide and is finding application in many 
other industry sectors as well. CDRH officials, working with 
counterpart foreign government officials, are pursuing in step-wise 
fashion the harmonization of quality system inspection procedures 
and enforcement.
    The process of harmonizing regulatory requirements is 
facilitated by using an international standard as a basis. Such 
harmonization is not only recognized public policy, but for medical 
devices, it is explicitly encouraged by provisions of SMDA (Pub. L. 
101-629), which states, in part, that FDA ``* * * may enter into 
agreements with foreign countries to facilitate commerce in devices 
between the United States and [foreign] countries consistent with 
the requirements of this Act.'' 21 U.S.C. 383.
    In a recent (April 1995) program review, CDRH reported that in 
1994, 192 Center staff members served as primary and alternate 
liaison representatives on 440 committees and subcommittees in 38 
standards developing organizations (domestic and foreign). CDRH 
actively reviewed 286 draft standards; of these, 134 were with nine 
international standards organizations. The experience CDRH has 
acquired over the years has provided the foundation for the 
standards policy it announced on June 29, 1993. The essential 
features of that policy are reflected in the FDA policy presented in 
section IV. below.

4. Regulatory Affairs

    FDA's Office of Regulatory Affairs (ORA) is increasingly active 
in international standards activities relevant to quality control 
and conforming assessment, including activities relevant to ISO--
9001 and laboratory regulation.

III. Response to Comments

    In response to its request for comments on the draft 
international harmonization policy on standards, FDA received 
comments from ten organizations (standards setting organizations, 
trade and professional associations, a manufacturer, and a consumer 
organization). A discussion of the comments received and the 
agency's responses follow.
    1. In general, the comments supported the agency's proposed 
international harmonization policy on standards. For example, one 
comment stated that the policy demonstrated the agency's commitment 
to the international standards development process as well as 
international harmonization. Another comment pointed out that the 
policy will better enable the agency to establish agreements with 
other global regulatory bodies, and ultimately permit FDA to carry 
out its mandate to protect the public health in a more efficient and 
cost effective manner. Other comments stated that the harmonization 
of regulatory requirements and supportive standards could benefit 
U.S. companies engaged in international trade. In addition, one of 
these 

[[Page 53082]]
comments pointed out that standards reflect technology, and that the 
first priority with regard to standards should always be to develop 
standards that represent the best available technological solutions, 
adding that `harmony' and `consistency' can be achieved through the 
general acceptance of excellent technological solutions. FDA agrees 
with these comments.

A. Potential for Lowered Standards

    2. Two comments stated that harmonization has the potential to 
result in lowered standards, with potential adverse effects on 
public health protection. One of the comments expressed concern that 
FDA was subordinating the public interest in favor of voluntary 
standards bodies and standards developing groups in a manner that is 
inconsistent with the vital tasks assigned to the agency to protect 
health. The second comment argued that the first priority with 
regard to standards should be to develop standards that represent 
the best available technological solutions, and that FDA should not 
support international standards that reflect inferior or compromised 
technological solutions that become obstacles, rather than benefits, 
to U.S. industry. Another comment, while agreeing that international 
standards should be adopted as national standards whenever possible, 
stated that international standards may sometimes not meet the needs 
of our health care community, adding that some may contain safety 
standards only and no performance parameters, and that the 
international standards may also be inconsistent with our country's 
codes and regulations.
    FDA wishes to reassure those who commented that FDA's 
participation in international harmonization activities is intended 
to safeguard the U.S. public health and to assure that consumer 
protection standards and requirements are met. Indeed, a central 
principle that guides the agency's international harmonization 
activities is that the activities should further FDA's mission to 
protect the public health. In addition, international agreements to 
which the U.S. Government is a party have provisions that ensure 
that harmonization activities will not result in lowered standards. 
For example, the WTO Agreement on SPS provides that each country may 
determine its appropriate level of protection; therefore, the 
encouragement to use international standards as the basis for 
technical regulations will not result in ``downward harmonization.'' 
Safeguards have been built into the TBT agreement and U.S. 
implementing legislation that protect the ability of each country to 
establish requirements necessary to fulfill a legitimate objective. 
As stated in section I.C.1. above, the implementing legislation for 
the new TBT agreement, which provides additional authority for FDA's 
international standards activities, provides further assurance that 
such harmonization would not result in lowering safety or quality 
standards for U.S. consumers. Thus, the agency does not agree that 
harmonization will result in inferior standards. Furthermore, FDA's 
participation in standards development, consistent with Sec. 10.95 
and OMB Circular No. A-119, and FDA's use of standards in its 
regulatory programs, will be dependent not only on the substantive 
aspects of the standards for ensuring the safety, effectiveness, and 
quality of products, but also on the development process for the 
standard. The standard itself must also comply with all applicable 
statutes, regulations, and policies.

B. Regulatory Issues

    3. One comment stated that any time a voluntary standard is used 
in a regulation, the scope of that standard needs to be 
unambiguously determined. The comment used a hypothetical case of a 
voluntary standard intended to be used in the home environment being 
inappropriately extended to the hospital environment. The comment 
argued that if the regulatory need exceeds the scope of the existing 
voluntary standard, it may indicate the need for yet another 
voluntary standard that addresses the additional scope, or else 
provisions may need to be added to the existing voluntary standard 
so as to accommodate the broader scope in which the standard is to 
be applied.
    The agency agrees that when a voluntary standard is used in a 
regulation, the scope of that standard should be unambiguously 
expressed. As stated above, a basic tenet in the development and 
adoption of a standard is that it contributes to safer, more 
effective, and higher quality products. Inappropriate application of 
a standard (voluntary or as part of a technical regulation) would 
run counter to this notion.
    4. Three comments questioned the need to make voluntary 
standards mandatory regulations. One of the comments stated that if 
the agency uses a voluntary standard as a ``referee'' standard, 
which means that the agency uses the voluntary standard as a frame 
of reference for determining safety and efficacy, there should be no 
need for the agency to go through the procedures required for 
creating a regulation. The second comment stated that if technical 
standards are based on state-of-the-art science and are revised as 
needed to incorporate advances, they should be voluntary standards 
as opposed to regulatory requirements. The third comment asserted 
that existence of a standard does not warrant a regulation and FDA 
should avoid unnecessary regulations.
    The agency agrees that it should avoid unnecessary regulations 
but notes that there are times when it finds it is necessary to 
propose and promulgate regulations for the efficient enforcement of 
the laws it administers. Voluntary standards that will serve 
agencies' purposes and are consistent with applicable laws and 
regulations can be adopted and used by Federal agencies. This 
principle is stated in both FDA's policy and in section 7(a) of OMB 
Circular No. A-119 on Reliance on Voluntary Standards. Thus, when 
appropriate, FDA will adopt voluntary standards by referencing them 
in the regulations it promulgates. In all other instances, these 
standards will remain voluntary.
    As stated above, the purpose of FDA's involvement in the 
development and use of standards is to assist the agency in 
fulfilling its public health and regulatory missions. Thus, the 
agency intends to participate in the development of domestic and 
international standards, and to adopt or use standards, when such 
action will enhance its ability to protect consumers and the 
effectiveness or efficiency of its regulatory efforts.

C. Transparency

    5. Four comments addressed the need for transparency during the 
development of standards, in determining ``official'' use of a 
standard, or when standards are used in a regulation or adopted as 
regulations. The comments asserted that, if voluntary standards are 
incorporated into guidance documents and compliance policy guides 
and serve as the bases for mandatory standards and other regulations 
promulgated by FDA, ample opportunity should be provided for 
interested parties to comment through the established procedures of 
notice and comment rulemaking. One comment further stated that the 
policy should include a statement of assurance that FDA will engage 
potentially affected parties whenever it intends formal inclusion of 
a voluntary standard in an FDA document or process.
    The agency agrees that the development of standards should be 
conducted in an open fashion. Under Sec. 10.95, one of the criteria 
for FDA participation in standards-setting bodies is that the group 
or organization responsible for the standard-setting activity must 
have a procedure by which an interested person will have an 
opportunity to provide information and views on the activity and 
standards involved, and that the information and views will be 
considered. This is why FDA clearly states in its policy (section 
IV. below) that one of the factors for FDA's participation in 
standards development and use is the transparency of the process, 
i.e., the process must be open to public scrutiny and provide the 
opportunity for the consideration of views of all parties concerned.
    With regard to transparency when standards are used in a 
regulation or adopted as regulations, under the Administrative 
Procedure Act (APA), an agency that issues, amends, or revokes a 
regulation, whether on its own initiative or when petitioned by an 
interested person, must act in an open manner with adequate time 
provided for comment from interested parties, which will be 
considered before a final regulation is promulgated. FDA's rule on 
promulgation of regulations, found in 21 CFR 10.40, is explicit with 
respect to the need for transparency of the process and opportunity 
for participation in the process by interested persons. Other 
procedural regulations govern guidelines and similar documents (21 
CFR 10.90), and interested persons may use correspondence or 
meetings (21 CFR 10.65), petitions (21 CFR 10.30), or reviews by 
supervisors (21 CFR 10.75) to raise issues and present views about 
other nonbinding guidance documents, which provide industry with 
useful information about recommended or alternative ways to comply 
with requirements. In fact, FDA has increasingly used public 
meetings to elicit and share information with regard to its guidance 
documents and it currently is reviewing the procedures it uses to 
develop guidance documents to ensure sufficient transparency in the 
process.
    Thus, with regard to the comment that this policy should include 
a statement of 

[[Page 53083]]
assurance that FDA will engage potentially interested parties whenever 
it intends formal inclusion of a voluntary standard in an FDA 
document or process, the agency finds that it is not necessary to do 
so as part of this document because there are established mechanisms 
under the APA and the agency's administrative practices and 
procedure regulations for obtaining and considering views of 
interested persons. Of course, FDA is not foreclosing future 
consideration of additional mechanisms toward this end.

D. Comments on Specific Issues

    6. One comment suggested the alternative language, ``The 
standard contributes to safe and effective products that meet 
consumers' requirements for quality,'' instead of ``The standard 
contributes to safer, more effective, and higher quality products'' 
(section III.A.1., proposed policy) and ``The standard, if adhered 
to, would help ensure the safety, effectiveness, or quality of 
products'' (section III.D.1., proposed policy). The alternative 
language was offered to simplify future negotiations and to allow 
the agency to participate more fully in standards development and 
promulgation. The comment also questioned the use of the terms 
`safer' and `more effective' in section III.A.1. of the proposed 
policy (see above) because it is not clear what the measures for 
`safer' and `more effective' are. The comment further stated that 
the term ``higher quality'' is relative, leaving open to question 
who determines higher quality. Finally, the comment added that an 
international standard could conceivably result in requirements for 
the same degree of safety, effectiveness, and quality as those 
required by FDA.
    The agency is revising the policy in a manner similar to that 
suggested by the comment. FDA agrees that an international standard 
could indeed result in requirements for the same degree of safety, 
effectiveness, and quality as required by FDA. In fact, one of FDA's 
guiding principles in its international harmonization activities is 
that FDA should accept, where legally permissible, equivalent 
standards of other countries provided such standards meet FDA's 
goals to facilitate the availability of safe, effective, and 
properly labeled products. The agency further agrees that the 
alternative language would allow the agency more flexibility to 
participate in standards development, without compromising public 
health, and is therefore amending the policy accordingly.
    7. One comment supported FDA's intent to develop standards on 
the basis of sound scientific and technical information. The comment 
added that the use of sound scientific and technical information 
will permit the development of food regulations and standards that 
cannot be misconstrued as unreasonable trade barriers. However, the 
comment cautioned that a decision on participation in standards 
development should be based on the purpose of the standard, not 
whether the standard is based on sound scientific and technical 
information.
    The agency agrees that while all standards should be based on 
sound scientific and technical information, not all scientifically 
sound standards will serve purposes justifying the agency's 
participation in developing them. FDA's regulation on participation 
in outside standard-setting activities states that not only will the 
activity be based upon consideration of sound scientific and 
technological information, but it also will be designed to protect 
the public against unsafe, ineffective, or deceptive products and 
practices (21 CFR 10.95(d)(5)(i)). In addition, OMB Circular No. A-
119 states that it is the policy of the Federal Government to 
participate in voluntary standards bodies when such participation is 
in the public interest and is compatible with agencies' missions, 
authorities, priorities, and budget resources. The OMB Circular adds 
that the providing of agency support to a voluntary standards 
activity should be limited to that which is clearly in furtherance 
of an agency's mission and responsibility. These directives are 
adequately reflected in the policy.
    8. One comment suggested that proposed section III.A.4., ``The 
development of an international standard that achieves the agency's 
public health objectives is generally, but not always, given a 
higher priority than the development of a domestic standard,'' be 
deleted because it is made clear in other parts of the draft policy 
that FDA complies with U.S. obligations under the GATT, other 
international trade agreements, and OMB Circular No. A-119.
    The agency agrees that the draft policy document does make clear 
that FDA complies with U.S. obligations under international 
agreements and the OMB Circular. However, the agency does not agree 
that proposed section III.A.4. should be deleted. FDA's belief that 
the development of an international standard that achieves the 
agency's public health objectives is generally (but not always) 
given a higher priority than the development of a domestic standard, 
is an important factor on which agency participation in standards 
development is based and merits being clearly delineated. This is 
more so because proposed section III (section VI. of this document), 
FDA Policy on Standards, is intended to stand on its own as the 
agency's policy on harmonization of standards and, therefore, needs 
to be as complete as possible.
    FDA emphasizes that there are three routes to development of a 
harmonized international standard, all of which are favored under 
the FDA policy: (1) The U.S. voluntary standards community or an 
agency, such as FDA, develops a U.S. standard and takes it to an 
international forum so it can be made an international standard; (2) 
a standard already developed in an international forum (or by 
another country or a regional standards body) is adopted as a U.S. 
voluntary or regulatory standard; or (3) a new international 
standard is developed, ``from scratch,'' in an international forum. 
Which of these routes is followed in the particular case will vary 
with the facts of that case. While starting a standards activity in 
an international forum offers many efficiencies in avoiding 
duplication of effort, there will continue to be times when it makes 
sense first to develop a domestic standard (voluntary or regulatory) 
and then to take it, as appropriate, to an international forum.
    9. One comment asserted that the intent of proposed factors 
III.A.6. and III.D.6., which state: ``Wherever appropriate for the 
product, the standard stresses product performance rather than 
product design, but where necessary, covers all factors required to 
ensure safety, effectiveness, and quality,'' was not clear. The 
comment added that inspection can be used to prevent poor quality 
products from being consumed but that safety cannot be inspected 
into a product. The comment stated further that safety must be 
designed into products during development, subsequent manufacturing, 
packaging, and transport. Further, the comment stated that product 
performance or product functionality issues with regard to safety 
are the primary focus in the development of food regulations, and 
therefore, the comment recommended alternative language to that in 
the proposed policy: ``Wherever appropriate for the product, the 
standard stresses product safety, performance, and functionality, 
but where necessary, covers all factors required to ensure safety 
and effectiveness, including product and process design, and process 
performance.''
    The agency believes that the suggested language is helpful in 
capturing FDA's intentions in formulating these factors as the basis 
for participation in standards development, and use of standards in 
its regulatory programs. Therefore, the agency is making editorial 
changes in the factors along the lines suggested in the comment.

E. Other Comments

    10. One comment recommended that FDA review and revise current 
U.S. guidelines for toxicity testing of food additives as outlined 
in the Toxicological Principles for the Safety Assessment of Direct 
Food Additives and Color Additives Used in Food (Redbook I), as well 
as the proposed guidelines set forth in the revised draft, Redbook 
II, and harmonize with those recommended by the OECD. The comment 
added that this will allow more universal acceptance of results 
performed throughout the world and will minimize the need to repeat 
expensive testing to meet different testing standards in different 
countries.
    The agency has stated that standards activities of organizations 
such as OECD are often important to FDA, and that the development of 
international standards, and harmonization with international 
standards if they achieve the agency's public health objectives, 
will in most instances be given a high priority.
    The agency announced that the draft Redbook II was available 
(March 29, 1993, 58 FR 16536) and solicited comments on the draft 
revised guidelines. Redbook II is being finalized in light of 
comments received by the agency, including a comment that the 
guidelines should be harmonized with those of the OECD; the final 
revised Redbook II has yet to be issued. The agency notes that, in 
revising the guidelines in the Redbook, it took into account the 
fact that differences among guidelines can result in unnecessary 
duplication of effort and inefficient use of 

[[Page 53084]]
scarce testing resources. The agency also wants to make clear that the 
Redbook is designed to provide guidance. Strict adherence to Redbook 
guidelines is not a requirement for toxicological studies conducted 
to establish the safety of an additive.
    11. One comment indicated concern that a long standing 
participation by the United States Public Health Service in the 3-A 
Sanitary Standards (for dairy and related food industries) is not 
mentioned in the text of the draft policy. The comment also stated 
that it is necessary that, as international agreements anticipate 
trade and importation of equipment, compliance with 3-A Sanitary 
Standards should be applied by reference to assure receipt of 
acceptable equipment.
    The domestic and international standards-setting organizations 
or bodies listed under section II.B. of this document are those in 
which FDA has been or is most actively involved in developing 
standards. The listing is not meant to be exhaustive nor is it meant 
to list all standards setting bodies in which FDA has an interest.
    12. One comment urged FDA to reference voluntary standards 
rather than adopting and publishing standards, to maintain 
appropriate support for standards development. The comment argued 
that referencing rather than publishing the text of voluntary 
standards as regulations or guidance protects the standards 
organizations' copyrights which provide the financial support for 
national and international programs.
    FDA uses standards in the manner described in OMB Circular No. 
A-119, which states that while voluntary standards adopted by 
Federal agencies should be referenced along with their dates of 
issuance and sources of availability in appropriate publications, 
regulatory orders, and in related in-house documents, such adoption 
should take into account any applicable requirements of copyright 
law and other similar restrictions.
    13. One comment advised that the value of standards is that they 
are the consensus product of all technology experts, not just the 
consensus of experts from government. Therefore, care should be 
exercised that government participation in voluntary standards 
organizations and its use of voluntary standards does not lead to an 
appearance that voluntary standards organizations are unduly 
directed or influenced by government.
    The agency is sensitive to the need for balanced participation 
in voluntary standards bodies and works within OMB's guidelines 
regarding policy to be followed by executive agencies in working 
with voluntary standards bodies. OMB Circular No. A-119 states that 
agency representatives serving as members of standard-developing 
groups should participate actively and on a basis of equality with 
private sector representatives but that, in doing so, agency 
representatives should not seek to dominate such groups. In 
addition, the number of individual agency participants in a given 
voluntary standards activity should be kept to the minimum required 
for effective presentation of the various program, technical, or 
other concerns of Federal agencies. Finally, while the circular 
encourages agency representatives to participate in the policy-
making process of voluntary standards bodies, particularly in 
matters such as establishing priorities, developing procedures for 
preparing, reviewing and approving standards, and creating 
standards-developing groups, it also states that in order to 
maintain the private, nongovernmental nature of such bodies, agency 
representatives should refrain from decisionmaking involvement in 
the internal day-to-day management of such bodies.

F. Conclusion

    Therefore, after considering the comments received, FDA is 
issuing this statement of policy.

IV. FDA Policy on Standards\1\

    \1\This policy document does not create or confer any rights, 
privileges, or benefits, for or on any person, nor does it operate 
to bind FDA in any way.
---------------------------------------------------------------------------

    It is the intent of this policy to enable FDA to: (1) Continue 
to participate in international standards activities that assist it 
in implementing statutory provisions for safeguarding the public 
health, (2) increase its efforts to harmonize its regulatory 
requirements with those of foreign governments, including setting 
new standards that better serve public health, and (3) respond to 
laws and policies such as the Trade Agreements Act and OMB Circular 
No. A-119 that encourage agencies to use international standards 
that provide the desired degree of protection. Accordingly, it is 
the policy of FDA, concerning the development and use of standards, 
that:
    A. FDA participation in standards development will be based on 
the extent to which the development activity and expected standard 
conform to certain factors, with consideration also being given to 
the resources available in FDA to devote to the effort and expected 
efficiencies to be gained as a result of the effort; the factors are 
as follows:
    1. The standard stresses product safety and effectiveness and 
therefore contributes to safe, effective, and high quality products; 
when necessary, the standard also covers all factors required to 
ensure safety and effectiveness, including product and process 
design, and process performance;
    2. The standard is based on sound scientific and technical 
information and permits revision on the basis of new information;
    3. The development process for the standard is transparent 
(i.e., open to public scrutiny), complies with applicable statutes, 
regulations, and policies, specifically including Sec. 10.95 and OMB 
Circular A-119, and is consistent with the codes of ethics that must 
be followed by FDA employees;
    4. The development of an international standard that achieves 
the agency's public health objectives is generally, but not always, 
given a higher priority than the development of a domestic standard; 
and
    5. The development of a horizontal standard which applies to 
multiple types of products is generally, but not always, given 
higher priority than the development of a vertical standard which 
applies to a limited range of types of products.
    B. FDA is not bound to use standards developed with FDA 
participation. For example, the agency will not use a standard when, 
in the judgment of FDA, doing so will compromise the public health.
    C. The uses of final (and selected draft or proposed) standards, 
or selected relevant parts, will include, where appropriate: (1) 
Incorporating such standards into guidance documents for nonclinical 
testing, applications for conducting clinical trials with 
investigational products, and applications for permitting products 
to be marketed; (2) conducting reviews of such applications; (3) 
incorporating such standards into compliance policy guides; (4) 
conducting reviews of test protocols used by firms as part of good 
manufacturing practices; (5) conducting reviews of study protocols 
submitted by firms as required for postmarket surveillance studies 
or programs; (6) serving as the basis for mandatory standards or 
other regulations promulgated by FDA; and (7) serving as the basis 
for reference (e.g., evaluation criteria) in a memorandum of 
understanding with other government agencies.
    D. The use of a standard in the regulatory programs of FDA is 
dependent upon the following factors:
    1. The standard stresses product safety and effectiveness and 
therefore, if adhered to, would help ensure the safety, 
effectiveness, or quality of products; when necessary, the standard 
also covers all factors required to ensure safety and effectiveness, 
including product and process design, and process performance;
    2. The standard is based on sound scientific and technical 
information and is current;
    3. The development process for the standard was transparent 
(i.e., open to public scrutiny), was consistent with the codes of 
ethics that must be followed by FDA employees, and the standard is 
not in conflict with any statute, regulation, or policy under which 
FDA operates;
    4. Where a relevant international standard exists or completion 
is imminent, it will generally be used in preference to a domestic 
standard, except when the international standard would be, in FDA's 
judgment, insufficiently protective, ineffective, or otherwise 
inappropriate; and
    5. Where a relevant horizontal standard which applies to 
multiple types of products exists or its completion is imminent, it 
will generally be used in preference to a vertical standard, which 
applies to a limited range of types of products, except when such 
horizontal standard would be insufficiently protective, ineffective 
or otherwise inappropriate.
    E. FDA employees will comply with agency regulations 
(Sec. 10.95) covering participation in standard setting activities 
outside the agency.

    Dated: October 4, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-25070 Filed 10-10-95; 8:45 am]
BILLING CODE 4160-01-F