,,ii #aahth ,,congress #b;d ,session ,s4 #ddbh ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,may #bc1 #bjbd,mr4 ,young 7for himself and ,mr4 ,padilla7 introduced the following bill2 which was read twice and referred to the ,committee on ,commerce1 ,science1 and ,transportation ,a ,,bill ,to establish an interagency committee to coordinate activities of the ,federal ,government relating to biotechnology oversight1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,biotechnology ,oversight ,coordination ,act of #bjbd4 #b4 ,findings2 purpose 7a7 ,findings ,congress finds that-- 7#a7 biotechnology harnesses the power of biology to create new products and provides opportunities to grow the ,united ,states economy1 provide jobs for a skilled workforce1 improve resilience of supply chains1 and improve the quality of human lives and the environment2 and 7#b7 a science-based1 risk-proportionate1 predictable1 efficient1 and transparent system to support the safe use of products of biotechnology will enable the ,united ,states to continue to be a world leader in biotechnology research and development4 7b7 ,purpose ,the purpose of this ,act is to coordinate and enhance the efforts of the ,federal ,government under the ,coordinated ,framework for the ,regulation of ,biotechnology to protect health and the environment while enabling the development1 commercialization1 and safe use of products derived from plants1 animals1 and microorganisms developed with biotechnology4 #c4 ,biotechnology ,oversight ,coordination ,committee 7a7 ,establishment of ,committee 7#a7 ,in general ,the ,president1 acting through the ,director of the ,office of ,science and ,technology ,policy and the ,director of the ,office of ,management and ,budget1 shall establish an interagency committee to coordinate activities of the ,federal ,government relating to biotechnology-specific regulation and oversight 7referred to in this section as the ,committee74 7#b7 ,charter 7,a7 ,in general ,not later than #ij days after the date of enactment of this ,act1 the ,committee shall-- 7i7 ratify a charter for the operation of the ,committee2 and 7ii7 make publicly available on the ,unified ,website for ,biotechnology ,regulation developed pursuant to ,executive ,order #achgd 7#g ,u4,s4,c4 #caba note2 relating to modernizing the regulatory framework for agricultural biotechnology products7 7referred to in this section as the ,unified ,website7 that ratified charter4 7,b7 ,expansion or modification ,the ,committee may expand upon or modify the initial ratified charter under subparagraph 7,a77i7 as needed4 7b7 ,membership ,the ,committee shall be composed of the heads1 or their designees1 of agencies responsible for biotechnology oversight1 including-- 7#a7 the ,animal and ,plant ,health ,inspection ,service1 the ,agricultural ,marketing ,service1 and the ,food ,safety and ,inspection ,service of the ,department of ,agriculture2 7#b7 the ,food and ,drug ,administration and the ,national ,institutes of ,health of the ,department of ,health and ,human ,services2 7#c7 the ,environmental ,protection ,agency2 7#d7 the ,office of ,management and ,budget2 7#e7 the ,office of ,science and ,technology ,policy2 and 7#f7 other ,federal agencies or entities as determined appropriate by the ,chair of the ,committee4 7c7 ,chair ,the ,director of the ,office of ,science and ,technology ,policy shall serve as the ,chair of the ,committee4 7d7 ,regulatory streamlining ,the ,committee shall expand or build upon efforts to coordinate biotechnology oversight1 including through measurable steps-- 7#a7 to align or clarify regulatory timelines1 approaches1 and data requirements2 7#b7 to facilitate information-sharing between regulatory agencies1 notwithstanding any other provision of law2 7#c7 to identify an initial point of contact for each type of biotechnology product1 including emerging products1 and clear hand-offs from one process or agency to another2 7#d7 to identify and minimize any areas of delay relative to established timeframes1 including by reducing duplicative review and building upon prior reviews to the maximum extent practicable2 and 7#e7 to conduct periodic horizon-scanning for emerging biotechnology processes and products to ensure appropriate oversight4 7e7 ,report to ,congress ,not later than #a year after the date of enactment of this ,act1 and annually thereafter1 the ,committee shall submit to ,congress and make publicly available on the ,unified ,website a description of the following3 7#a7 ,actions taken and next steps under subsection 7d71 with a description of successes1 specific staffing and resource needs1 and recommendations for removing any identified barriers1 including changes to statutes1 regulations1 or guidance4 7#b7 ,a summary of the duration of oversight with respect to biotechnology products1 from the initial contact with a developer to a decision with respect to the biotechnology product1 during a period of not less than #e fiscal years preceding the date of the report1 including-- 7,a7 the type of product2 7,b7 the #a or more types of review2 7,c7 the #a or more agencies that reviewed that product2 and 7,d7 an explanation of timelines where needed4 7f7 ,unified process ,not later than #ahj days after the date of enactment of this ,act1 and annually thereafter1 the ,committee shall submit to ,congress and make publicly available on the ,unified ,website the following3 7#a7 ,a singular1 unified process to identify whether a plant1 animal1 or microorganism produced with biotechnology could reasonably have occurred naturally or been developed by conventional means 7meaning the genetic sequences of the biotechnology product are present in the gene pool of the plant1 animal1 or microorganism or could have arisen through natural mutation mechanisms71 taking into account existing agency assessments where appropriate4 7#b7 ,measurable actions the ,committee and any member of the ,committee will take to implement or consider the unified process described in paragraph 7#a7 in their oversight of biotechnology products1 taking into account that organisms identified via the process described in paragraph 7#a7 would continue to be regulated with product-specific oversight4 7#c7 ,actions taken and progress made with respect to paragraph 7#b74 7g7 ,molecular farming and precision fermentation ,not later than #ahj days after the date of enactment of this ,act1 and annually thereafter1 the ,committee shall submit to ,congress and make publicly available on the ,unified ,website a description of the following3 7#a7 ,characteristics of organisms that may increase risk pathways or otherwise hinder the production of substances intended for extraction4 7#b7 ,characteristics of organisms that may reduce risk pathways associated with the production of substances intended for extraction4 7#c7 ,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 extraction4 7#d7 ,examples of organisms that-- 7,a7 fit some or all of the characteristics described in paragraph 7#b72 and 7,b7 are amenable to some or all of the conditions described in paragraph 7#c74 7#e7 ,measurable actions the ,committee and any member of the ,committee will take to implement or consider the characteristics described in paragraph 7#b7 and the conditions described in paragraph 7#c7 into their oversight of biotechnology products4 7#f7 ,actions taken under paragraph 7#e7 and progress made with respect to those actions4 7h7 ,coordination and consultation 7#a7 ,coordination ,the ,committee shall coordinate1 as appropriate1 with-- 7,a7 other working groups and committees of the ,federal ,government2 and 7,b7 other relevant agencies4 7#b7 ,consultation ,the ,committee shall regularly consult in a coordinated fashion regarding biotechnology oversight1 including with respect to the reports under subsection 7e71 with ,states1 ,indian ,tribes1 territories1 local governments1 biotechnology developers and relevant industries1 academic institutions1 nongovernmental organizations1 and other stakeholders4 7i7 ,executive ,secretaries 7#a7 ,department of ,agriculture ,the ,secretary of ,agriculture shall appoint an ,executive ,secretary to serve the ,committee1 who shall be and remain a permanent employee of the ,department of ,agriculture4 7#b7 ,department of ,health and ,human ,services2 ,environmental ,protection ,agency ,the ,secretary of ,health and ,human ,services and the ,administrator of the ,environmental ,protection ,agency may each appoint an ,executive ,secretary to serve the ,committee1 who shall be and remain a permanent employee of the ,department of ,health and ,human ,services and the ,environmental ,protection ,agency1 respectively4 7j7 ,comptroller ,general review ,the ,comptroller ,general of the ,united ,states shall-- 7#a7 not later than #a year after the date of enactment of this ,act1 begin a review to assess the efficacy of interagency coordination and other activities conducted by the ,committee2 7#b7 not later than #ah months after the date of enactment of this ,act1 provide to ,congress a briefing of the initial findings of the ,comptroller ,general with respect to the activities of the ,committee2 and 7#c7 not later than #b years after the date of enactment of this ,act1 provide to ,congress a report describing the current statutory authorities and oversight processes applicable to biotechnology-specific regulation of products derived from plants1 animals1 and microorganisms developed with biotechnology1 including a description of opportunities to reduce gaps1 duplication1 overlap1 and fragmentation4 7k7 ,exclusions ,this ,act shall not apply to human medical research and products that are regulated solely by the ,food and ,drug ,administration4