To prohibit approval by the Food and Drug Administration of genetically engineered fish unless the National Oceanic and Atmospheric Administration concurs with such approval.

SA 2108. Ms. MURKOWSKI (for herself, Mr. Begich, Mr. Merkley, Mr.
Sanders, Mr. Leahy, and Ms. Cantwell) submitted an amendment intended
to be proposed by her to the bill S. 3187, to amend the Federal Food,
Drug, and Cosmetic Act to revise and extend the user-fee programs for
prescription drugs and medical devices, to establish user-fee programs
for generic drugs and biosimilars, and for other purposes; which was
ordered to lie on the table; as follows:

At the end of title XI, add the following:

SEC. 11__. ANALYSES OF APPLICATION FOR APPROVAL OF
GENETICALLY-ENGINEERED FISH.

Notwithstanding any other provision of law, approval by the
Secretary of Health and Human Services of an application
submitted under the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 301 et seq.) for approval of any genetically modified
marine or anadromous organism shall not take effect until the
date that the Secretary of Commerce, acting through the Under
Secretary for Oceans and Atmosphere, approves such
application using standards applied by the Under Secretary
under the National Environmental Policy Act of 1969 (42
U.S.C. 4321 et seq.), which shall include a Regulatory Impact
Review required by Executive Order 12866 (58 Fed. Reg. 51735)
and Initial Regulatory Flexibility Analyses required under
chapter 6 of title 5, United States Code (commonly referred
to as the ``Regulatory Flexibility Act'').
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