regulation and oversight (referred to in this section 
as the ‘‘Committee’’). 
(2) CHARTER.— 
(A) IN GENERAL.—Not later than 90 days 
after the date of enactment of this Act, the 
Committee shall— 
(i) ratify a charter for the operation 
of the Committee; and 
(ii) make publicly available on the 
Unified Website for Biotechnology Regula-
tion developed pursuant to Executive 
Order 13874 (7 U.S.C. 3121 note; relating 
to modernizing the regulatory framework 
for agricultural biotechnology products) 
(referred to in this section as the ‘‘Unified 
Website’’) that ratified charter. 
(B) EXPANSION OR MODIFICATION.—The 
Committee may expand upon or modify the ini-
tial ratified charter under subparagraph (A)(i) 
as needed. 
(b) MEMBERSHIP.—The Committee shall be com-
posed of the heads, or their designees, of agencies respon-
sible for biotechnology oversight, including— 
(1) the Animal and Plant Health Inspection 
Service, the Agricultural Marketing Service, and the 
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Food Safety and Inspection Service of the Depart-
ment of Agriculture; 
(2) the Food and Drug Administration and the 
National Institutes of Health of the Department of 
Health and Human Services; 
(3) the Environmental Protection Agency; 
(4) the Office of Management and Budget; 
(5) the Office of Science and Technology Policy; 
and 
(6) other Federal agencies or entities as deter-
mined appropriate by the Chair of the Committee. 
(c) CHAIR.—The Director of the Office of Science 
and Technology Policy shall serve as the Chair of the 
Committee. 
(d) REGULATORY STREAMLINING.—The Committee 
shall expand or build upon efforts to coordinate bio-
technology oversight, including through measurable 
steps— 
(1) to align or clarify regulatory timelines, ap-
proaches, and data requirements; 
(2) to facilitate information-sharing between 
regulatory agencies, notwithstanding any other pro-
vision of law; 
(3) to identify an initial point of contact for 
each type of biotechnology product, including emerg-
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ing products, and clear hand-offs from one process 
or agency to another; 
(4) to identify and minimize any areas of delay 
relative to established timeframes, including by re-
ducing duplicative review and building upon prior re-
views to the maximum extent practicable; and 
(5) to conduct periodic horizon-scanning for 
emerging biotechnology processes and products to 
ensure appropriate oversight. 
(e) REPORT TO CONGRESS.—Not later than 1 year 
after the date of enactment of this Act, and annually 
thereafter, the Committee shall submit to Congress and 
make publicly available on the Unified Website a descrip-
tion of the following: 
(1) Actions taken and next steps under sub-
section (d), with a description of successes, specific 
staffing and resource needs, and recommendations 
for removing any identified barriers, including 
changes to statutes, regulations, or guidance. 
(2) A summary of the duration of oversight 
with respect to biotechnology products, from the ini-
tial contact with a developer to a decision with re-
spect to the biotechnology product, during a period 
of not less than 5 fiscal years preceding the date of 
the report, including— 
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(A) the type of product; 
(B) the 1 or more types of review; 
(C) the 1 or more agencies that reviewed 
that product; and 
(D) an explanation of timelines where 
needed. 
(f) UNIFIED PROCESS.—Not later than 180 days 
after the date of enactment of this Act, and annually 
thereafter, the Committee shall submit to Congress and 
make publicly available on the Unified Website the fol-
lowing: 
(1) A singular, unified process to identify 
whether a plant, animal, or microorganism produced 
with biotechnology could reasonably have occurred 
naturally or been developed by conventional means 
(meaning the genetic sequences of the biotechnology 
product are present in the gene pool of the plant, 
animal, or microorganism or could have arisen 
through natural mutation mechanisms), taking into 
account existing agency assessments where appro-
priate. 
(2) Measurable actions the Committee and any 
member of the Committee will take to implement or 
consider the unified process described in paragraph 
(1) in their oversight of biotechnology products, tak-
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ing into account that organisms identified via the 
process described in paragraph (1) would continue to 
be regulated with product-specific oversight. 
(3) Actions taken and progress made with re-
spect to paragraph (2). 
(g) MOLECULAR FARMING
AND PRECISION FER-
MENTATION.—Not later than 180 days after the date of 
enactment of this Act, and annually thereafter, the Com-
mittee shall submit to Congress and make publicly avail-
able on the Unified Website a description of the following: 
(1) Characteristics of organisms that may in-
crease risk pathways or otherwise hinder the produc-
tion of substances intended for extraction. 
(2) Characteristics of organisms that may re-
duce risk pathways associated with the production of 
substances intended for extraction. 
(3) Conditions that are useful for containing or 
segregating organisms produced with biotechnology 
that may reduce risk pathways associated with the 
production of substances intended for extraction. 
(4) Examples of organisms that— 
(A) fit some or all of the characteristics 
described in paragraph (2); and 
(B) are amenable to some or all of the con-
ditions described in paragraph (3). 
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(5) Measurable actions the Committee and any 
member of the Committee will take to implement or 
consider the characteristics described in paragraph 
(2) and the conditions described in paragraph (3) 
into their oversight of biotechnology products. 
(6) Actions taken under paragraph (5) and 
progress made with respect to those actions. 
(h) COORDINATION AND CONSULTATION.— 
(1) COORDINATION.—The Committee shall co-
ordinate, as appropriate, with— 
(A) other working groups and committees 
of the Federal Government; and 
(B) other relevant agencies. 
(2) CONSULTATION.—The Committee shall reg-
ularly consult in a coordinated fashion regarding 
biotechnology oversight, including with respect to the 
reports under subsection (e), with States, Indian 
Tribes, territories, local governments, biotechnology 
developers and relevant industries, academic institu-
tions, nongovernmental organizations, and other 
stakeholders. 
(i) EXECUTIVE SECRETARIES.— 
(1) DEPARTMENT OF AGRICULTURE.—The Sec-
retary of Agriculture shall appoint an Executive Sec-
retary to serve the Committee, who shall be and re-
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main a permanent employee of the Department of 
Agriculture. 
(2) DEPARTMENT
OF
HEALTH
AND
HUMAN 
SERVICES; 
ENVIRONMENTAL
PROTECTION
AGEN-
CY.—The Secretary of Health and Human Services 
and the Administrator of the Environmental Protec-
tion Agency may each appoint an Executive Sec-
retary to serve the Committee, who shall be and re-
main a permanent employee of the Department of 
Health and Human Services and the Environmental 
Protection Agency, respectively. 
(j) COMPTROLLER GENERAL REVIEW.—The Comp-
troller General of the United States shall— 
(1) not later than 1 year after the date of en-
actment of this Act, begin a review to assess the ef-
ficacy of interagency coordination and other activi-
ties conducted by the Committee; 
(2) not later than 18 months after the date of 
enactment of this Act, provide to Congress a briefing 
of the initial findings of the Comptroller General 
with respect to the activities of the Committee; and 
(3) not later than 2 years after the date of en-
actment of this Act, provide to Congress a report de-
scribing the current statutory authorities and over-
sight processes applicable to biotechnology-specific 
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regulation of products derived from plants, animals, 
and microorganisms developed with biotechnology, 
including a description of opportunities to reduce 
gaps, duplication, overlap, and fragmentation. 
(k) EXCLUSIONS.—This Act shall not apply to human 
medical research and products that are regulated solely 
by the Food and Drug Administration. 
Æ 
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