SEC. 491. NOTICE OF UNITED STATES PARTICIPATION IN INTERNATIONAL STANDARD-
SETTING ACTIVITIES.
- (a) IN GENERAL.-The President shall designate an agency to be
responsible for informing the public of the sanitary and phytosanitary
standard-setting activities of each international standard-setting organization.
- (b) NOTIFICATION.--Not later than June 1 of each year, the agency
designated under subsection (a) with respect to each international standard-setting
organization shall publish notice in the Federal Register of the information
specified in subsection (c) with respect to that organization. The notice
shall cover the period ending on June 1 of the year in which the notice
is published, and beginning on the date of the preceding notice under this
subsection, that the first such notice shall cover the 1-year period ending
on the date of the notice.
- (c) REQUIRED INFORMATION.--The information to be provided in the
notice under subsection (b) is-
- (1) the sanitary or phytosanitary standards under consideration
or planned for consideration by that organization;
- (2) for each sanitary or phytosanitary standard specified in paragraph
(1)-
- (A) a description of the consideration or planned consideration
of the standard;
- (B) whether the United States is participating or plans to
participate in the consideration of the standard;
- (C) the agenda for the United States participation, if any;
and
- (D) the agency responsible for representing the United States
with respect to the standard.
- (d) PUBLIC COMMENT.--The agency specified in subsection (c)(2)(D)
shall provide an opportunity for public comment with respect to the standards
for which the agency is responsible and shall take the comments into account
in participating in the consideration of the standards and in proposing
matters to be considered by the organization.
SEC. 492. EQUIVALENCE DETERMINATIONS.
- (a) IN GENERAL.-An agency may not determine that a sanitary or
phytosanitary measure of a foreign country is equivalent to a sanitary
or phytosanitary measure established under the authority of Federal law
unless the agency determines that the sanitary or phytosanitary measure
of the foreign country provides at least the same level of sanitary or
phytosanitary protection as the comparable sanitary or phytosanitary measure
established under the authority of Federal law.
- (b) FDA DETERMINATION. If the Commissioner proposes to issue a
determination of the equivalency of a sanitary or phytosanitary measure
of a foreign country to a measure that is required to be promulgated as
a rule under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et
seq.) or other statute administered by the Food and Drug Administration,
the Commissioner shall issue a proposed regulation to incorporate such
determination and shall include in the notice of proposed rulemaking the
basis for the determination that the sanitary or phytosanitary measure
of a foreign country provides at least the same level sanitary or phytosanitary
protection as the comparable Federal sanitary or phytosanitary measure.
The Commissioner shall provide opportunity for interested persons to comment
on the proposed regulations without taking into account the comments received.
- (c) NOTICE.--If the Commissioner proposes to issue a determination
of the equivalency of a sanitary or phytosanitary measure of a foreign
country to a sanitary or phytosanitary measure of the Food and Drug Administration
that is not required to be promulgated as a rule under the Federal Food,
Drug, and Cosmetic Act or other statute administered by the Food and Drug
Administration, the Commissioner shall publish a notice in the Federal
Register that identifies the basis for the determination that the measure
provides at least the same level of sanitary or phytosanitary protection
as the comparable Federal sanitary of phytosanitary measure. The Commissioner
shall provide opportunity for interested persons to comment on the notice.
The Commissioner shall not issue a final determination on the issue of
equivalency without taking into account the comments received.
SEC. 493. Definitions.
- (a) IN GENERAL.--As used in this subtitle:
- (1) AGENCY. The term "agency" means a Federal
department or agency (or combination of Federal departments or agencies).
- (2) COMMISSIONER.--The term "Commissioner" means
the Commissioner of Food and Drugs.
- (3) INTERNATIONAL STANDARD-SETTING ORGANIZATION.--The term "international
standard-setting organization" means an organization consisting
of representatives of 2 or more countries, the purpose of which is
to negotiate, develop, promulgate, or amend an international standard.
- (4) SANITARY OR PHYTOSANITARY STANDARD.--The term 'sanitary
or phytosanitary standard' means a standard intended to form a basis
for a sanitary or phytosanitary measure.
- (5) INTERNATIONAL STANDARD.--The term "international
standard" means a standard, guideline, or recommendation--
- (A) regarding food safety, adopted by the Codex Alimentarius
Commission, including a standard, guideline, or recommendation
regarding decomposition elaborated by the Codex Committee
on Fish and Fishery Products, food additives, contaminants,
hygienic practice, and methods of analysis and sampling;
- (B) regarding animal health and zoonoses, developed
under the auspices of the International Office of Epizootics;
- (C) regarding plant health, developed under the auspices
of the Secretariat of the International Plant Protection
Convention in cooperation with the North American Plant
Protection Organizations; or
- (D) established by or developed under any other international
organization agreed to by the NAFTA countries (as defined
in section 2(4) of the North American Free Trade Agreement
Implementation Act) or by the WTO members (as defined
in section 2(10) of the Uruguay Round Agreements Act).
- (b) OTHER DEFINITIONS.--The definitions set forth in section
463 apply for purposes of this subtitle except that in applying paragraph
(7) of section 463 with respect to a sanitary or phytosanitary measure
of a foreign country, any reference in such paragraph to the United States
shall be deemed to be a reference to that foreign country.
