,i #aahth ,,congress #ast ,session ,h4 ,r4 #dgjb ,,in ,,the ,,house ,,of ,,representatives ,july #ah1 #bjbc,ms4 ,eshoo introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,a ,,bill ,to require the ,secretary of ,health and ,human ,services to prescribe a regulation reducing the risks in gene synthesis products1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,securing ,gene ,synthesis ,act4 #b4 ,requirements for the dissemination of synthetic genetic material ,section #cea;,a of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb;a7 is amended-- 7#a7 in subsection 7b77#b71 by striking the semicolon at the end and inserting the following3 1 including by-- 7,a7 assessing uncertainties1 risks1 costs1 and benefits associated with the implementation of different types of protocols or other regulations to reduce the risk of potential misuse of de novo gene synthesis products2 7,b7 determining the types of protocols or other regulations that could detect the potential misuse of de novo gene synthesis products while generating benefits that are larger than their costs2 7,c7 requiring gene synthesis providers or manufacturers of gene synthesis equipment to implement screening protocols to detect misuse of de novo gene synthesis products2 7,d7 verifying or provisionally verifying that gene synthesis providers and manufacturers of gene synthesis equipment adhere to the regulation prescribed pursuant to subparagraph 7,c72 and 7,e7 assessing1 collecting1 and waiving fees for enforcing the regulation prescribed pursuant to subparagraph 7,c72 and 7,f7 requiring any entity receiving ,federal funds1 or any ,federal agency1 which purchases de novo gene synthesis products from a gene synthesis provider or gene synthesis equipment from a manufacturer of gene synthesis equipment to purchase such products and equipment only if such providers or manufacturers are verified or provisionally verified pursuant to subparagraph 7,d72 2 7#b7 in subsection 7e77#a71 by striking the period at the end and inserting 1 including through the revocation of ,federal research funding for any entity found to be in violation of subsection 7b77#b77;,e71 or through the withholding of such funding for such an entity until the entity demonstrates compliance with such subsection42 7#c7 in subsection 7k71 by adding at the end the following3 7#d7 ,use of gene synthesis products and gene synthesis equipment by ,federal agencies ,not later than ,january #a1 #bjbf1 the ,secretary shall report to the appropriate committees of ,congress a description of the policies and procedures adopted by all agencies that fund or conduct life sciences research involving gene synthesis products or gene synthesis equipment to comply with this section4 2 7#d7 in subsection 7l7-- 7,a7 by redesignating paragraphs 7#b71 7#c71 7#d71 7#e71 7#f71 7#g71 and 7#h7 as paragraphs 7#e71 7#f71 7#h71 7#i71 7#aj71 7#aa71 and 7#ab71 respectively2 7,b7 by inserting after paragraph 7#a7 the following3 7#b7 ,the term gene synthesis equipment means equipment that can produce gene synthesis product1 regardless of the technical mechanism by which such equipment works4 7#c7 ,the term gene synthesis product-- 7,a7 means custom single-stranded or double-stranded ,,dna1 or single-stranded or double-stranded ,,rna1 which has been chemically or enzymatically synthesized or otherwise manufactured de novo and is of a length exceeding the screening threshold2 and 7,b7 does not include-- 7i7 base chemical subunits1 such as individual nucleotides or nucleosides1 or oligonucleotides shorter than the screening threshold typically used as polymerase chain reaction primers2 7ii7 byproducts generated during sequencing that are not useful for assembly or cloning1 as determined by the ,secretary2 or 7iii7 products generated from cloning or assembling of existing gene or gene fragment material1 in circumstances in which the gene synthesis provider has no access or notice to the sequence design1 as determined by the ,secretary4 7#d7 ,the term gene synthesis provider-- 7,a7 means-- 7i7 an entity that creates gene synthesis product for delivery to a customer in the ,united ,states2 or 7ii7 a distributor of gene synthesis product in the ,united ,states1 including an entity that manufactures gene synthesis product for use by another party1 whether such other party is inside and outside of the entity2 and 7,b7 does not include-- 7i7 an entity making gene synthesis products for the entity's own use1 in circumstances in which the sequence has been previously screened in compliance with this section2 7ii7 an entity that manufactures gene synthesis products in the process of developing or manufacturing another product for a customer1 unless the gene synthesis product is provided to the end user thereof2 or 7iii7 any class of entity that the ,secretary chooses to exempt1 after consideration of the costs and benefits of exempting that class of entity from regulation under this section as a gene synthesis provider4 2 7,c7 by inserting after paragraph 7#f71 as so redesignated1 the following3 7#g7 ,the term manufacturer of gene synthesis equipment means an entity that produces for sale gene synthesis equipment4 2 and 7,d7 by adding at the end the following3 7#ac7 ,the term screening threshold means the minimal length of de novo gene synthesis product which ensures that the results of such screening contain enough information to allow an unambiguous analysis of such product's potential misuse4 2 and 7#e7 in subsection 7m71 by striking for each of the fiscal years #bjbc through #bjbg and inserting for fiscal year #bjbc and each subsequent fiscal year4