WORLD TRADE
ORGANIZATIONG/SPS/GEN/311
18 March 2002
(02-1384)
Committee on Sanitary and Phytosanitary Measures Original:  English
INFORMATION ON THE PROCESS FOR DEVELOPMENT OF US SPS
MEASURES AND EXPLANATION FOR THE VOLUME
OF RECENT US SPS NOTIFICATIONS
Submission by the United States
In response to the Chairman’s request to Members to provide additional information to the
Committee on their experiences with implementing the notification provisions of Article 7 and
Annex B of the SPS Agreement, the United States is pleased to provide this paper for the
Committee’s information and consideration.
Introduction
1. During the Committee’s October meeting, we noted the significant number of notifications
made by the United States to the Committee over the last several years.  During 2000 and 2001, for
example, the United States provided 323 SPS notifications to WTO.
2. The purpose of this paper is:  (1) to provide the Committee with an explanation of the general
nature of the US notifications and the process by which the United States develops them; and (2) to
explain that the recent increase in volume of US notifications is a direct result of legislative changes
in our food safety/pesticide laws.
The United States Administrative Procedures Act and Federal Rulemaking Requirements
3. In the United States, federal laws are written by the United States Congress, the Legislative
Branch of the US Government.  Rules/regulations are the means by which the President and the
Executive Branch, including various departments and agencies, implement the laws adopted byCongress.  US laws and regulations are subject to review by the Judicial Branch of government, i.e.,
the court system.
4. Standards-setting and regulatory procedures in the United States are required by law to be
transparent and nondiscriminatory.  The Administrative Procedures Act of 1946 (APA) is the primary
statute which establishes the basic framework for rulemaking.  In general, the APA requires a federal
agency desiring to issue a regulation, to publish the proposed rule in the United States government
journal, the Federal Register .  Publication is intended to provide all interested parties, including other
national governments, industries, organizations and individuals, an opportunity to comment on any
aspect of the proposal.
5. The notice generally includes the text and the intended purpose for the proposal and cites the
statutory authority and provisions affected by the proposed rule.  The explanation of the proposed rule
must be sufficient to inform the public of the rule’s purpose.  The notice of the proposed rule also
includes a request for comment and allows all interested persons a reasonable opportunity to submitG/SPS/GEN/311
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written data, views and/or concerns relating to the agency’s proposed rule.  Comments are typically
submitted in writing.  Generally, the public comment period begins as soon as the proposed rule is
published in the Federal Register  with a specific deadline to receive comments.
6. Federal law requires an agency to consider and respond to all significant comments submitted
during the comment period.  Frequently, agencies revise rules in response to comments receivedduring the rulemaking process.
7. In its response, a federal agency adopting a rule will publish a reasoned justification of the
rule, a summary of comments received from parties interested in the rule, the reasons why the agency
agrees or disagrees with the stakeholders comments, a restatement of the rule’s factual basis, and the
statement of authority under which the rule is adopted.
8. Once these procedures have been completed, the agency forwards its final rule for publication
in the Federal Register
.  The provisions of the final rule can be effective immediately, within a few
weeks, e.g., in 30 days or, in the case of major new rules, substantially longer.  In this manner, the
APA provides a structured and systematic means for ensuring a uniform and transparent rulemaking
process.  Final rules are generally subject to judicial review.
9. In general, the rulemaking process outlined above, governs the work of all federal agencies,
including the regulatory agencies whose measures are notified under the SPS Agreement.  TheseSPS-related regulatory agencies include the United States Environmental Protection Agency (EPA),
the United States Department of Agriculture's (USDA) Animal and Plant Health Inspection Service
(APHIS) and Food Safety and Inspection Service (FSIS), and the United States Food and Drug
Administration (FDA).  The US SPS Notification Authority submits notifications of proposals and
final rules developed by these agencies to the WTO immediately after their publication in the Federal
Register , usually within one or two days.
Recent Changes in United States Law Pertaining to Pesticides
10. In the United States, pesticide residue tolerances set by the EPA are then enforced by FDA.
FDA monitors domestically produced and imported foods traveling in interstate commerce, with theexception of meat, poultry and some egg products which are enforced by FSIS.  FDA is responsible
for all bulk and processed foods not under the jurisdiction of FSIS.  APHIS regulates products that
pose a risk to animal or plant health and is responsible for writing and enforcing such regulations.
11. As previously stated, during the years 2000 and 2001, the  United States notified 323 SPS
proposals.  The majority of the notifications (64 per cent) concerned EPA pesticide measures.  The
other 36 per cent were divided between the rest of the SPS-related regulatory agencies.  APHIS 17 per
cent, FDA 15 per cent;  and FSIS 4 per cent.  The large number of recent pesticide-relatednotifications is a result of EPA’s implementation of changes in US pesticide laws enacted in 1996 and
the development of new, lower risk pesticides.
12. In October 1996, the United States submitted document G/SPS/GN/4, detailing provisions of
the recently adopted Food Quality Protection Act (FQPA).  This law was unanimously passed by the
United States Congress  in August 1996 .  FQPA, which revised the appropriate level of protection for
pesticide residues, requires a comprehensive, integrated, and transparent approach to risk assessment
and risk management for pesticide residues in foods.  It established an appropriate level of protection
of a single  health-based standard for EPA’s decisions on maximum residue limits (MRLs) "a
reasonable certainty of no harm" which includes consideration of all non-occupational sources of
pesticide exposure.  FQPA also established a level of protection that provides for an additional 10-fold safety factor to protect children from threshold effects unless there are data demonstrating thatG/SPS/GEN/311
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using a different factor will be safe.  This safety factor was intended to make sure US Government
decisions on pesticide chemical residues will be more protective for children.
13. In terms of the number of SPS notifications to the WTO, FQPA not only required that all new
residue limits be assessed under the new standards, it also required that all existing maximum residue
limits be re-evaluated to ensure that they meet current safety standards.  In addition,  FQPA requires
the government to consider aggregate exposures to pesticide chemical residues.  Specifically EPA
must aggregate the potential exposures from all foods, drinking water, household use and any other
non-occupational exposure.  The law also requires the government to consider cumulative effects of
any pesticides and other chemicals that share a common mechanism of toxicity.
14. Nearly 10,000 existing tolerances are now underg oing review by EPA.  These reassessments
have led to a substantial increase in the number and frequency of changes to US pesticide residue
limits.  Since such changes may have a direct and substantial impact on food producers in othercountries who are required to comply  with the MRLs if they wish to  export food to the United States,
our government notifies all relevant changes in its pesticide residue limits to the WTO at as early a
stage as possible.  In addition, EPA has, and will continue, to host technical workshops in foreign
capitals to familiarize other countries with US levels of protection.
The Merits of a Strong Notification System:
15. Interested stakeholders which includes all interested parties - domestic and international -
play a vital role in shaping US regulatory policies.  Through extensive public involvement, the United
States is able to ensure that regulations are based on the latest information and scientific principles.  In
the WTO context, a review of and comment on any member’s proposal, though optional, can beeffective in minimizing potential trade disruptions.  By providing comments on the notifications of the
other members, The United States has successfully encouraged changes to provisions of other
members’ proposals that would have had unintended or negative trade consequences.
16. In January 2001, in an effort to enhance transparency under the SPS Agreement, the United
States began, with guidance from the WTO Secretariat, to notify the Committee of final rules by wayof addenda to the original proposal.  We believe it is very important to notify members of changes in
the final rule and to alert other Members when these rules come into effect.  Since January 2001, the
United States has notified 67 final rules published by SPS related regulatory agencies.
17. This information is provided to Members to assist in understanding both the US process for
development of SPS measures and the nature of many of its recent notifications to the WTO.
Transparency, particularly timely and effective notification of all relevant SPS measures, should be a
high priority for all Members.
18. The US Government is committed to ensuring full implementation of SPS Agreement.  In our
opinion, transparency, as outlined in the Agreement, can only be achieved when countries notify other
Members of all significant changes to sanitary or phytosanitary measures on a timely basis.  Equally
important is that these measures be based on scientific principles and scientific evidence and involve
all interested stakeholders.  We encourage all members to take full advantage of the notificationprocess to enhance our understanding of each other’s regulatory systems.
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