Assembly Bill A3283C

                             
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   3283
 
                        2025-2026 Regular Sessions
 
                           I N  A S S E M B L Y
 
                             January 27, 2025
                                ___________
 
 Introduced  by M. of A. BORES -- read once and referred to the Committee
   on Health
 
 AN ACT to amend the public health law, in relation to establishing mini-
   mum protocol requirements for gene synthesis providers and manufactur-
   ers of gene synthesis equipment
 
   THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND  ASSEM-
 BLY, DO ENACT AS FOLLOWS:
 
   Section  1.  Short  title. This act shall be known and may be cited as
 the "bioterrorism prevention act".
   § 2. The public health law is amended by adding a new article 32-B  to
 read as follows:
                               ARTICLE 32-B
                            GENE SYNTHESIS LABS
 SECTION 3230. MINIMUM PROTOCOL REQUIREMENTS FOR GENE SYNTHESIS PROVIDERS
                 AND MANUFACTURERS OF GENE SYNTHESIS EQUIPMENT.
   § 3230. MINIMUM PROTOCOL REQUIREMENTS FOR GENE SYNTHESIS PROVIDERS AND
 MANUFACTURERS  OF  GENE  SYNTHESIS  EQUIPMENT.  1.    ANY GENE SYNTHESIS
 PROVIDER OR MANUFACTURER OF GENE SYNTHESIS EQUIPMENT IN THE STATE  SHALL
 OPERATE  IN  ACCORDANCE  WITH  INTERNATIONAL  GENE  SYNTHESIS CONSORTIUM
 PROTOCOLS.
   2. GENE SYNTHESIS PROVIDERS AND MANUFACTURERS OF GENE SYNTHESIS EQUIP-
 MENT SHALL, AT A MINIMUM:
   (A) SCREEN  SYNTHETIC  GENE  ORDERS  TO  IDENTIFY  REGULATED  PATHOGEN
 SEQUENCES AND OTHER POTENTIALLY DANGEROUS SEQUENCES;
   (B)  SCREEN  THE  COMPLETE  DNA SEQUENCE OF EVERY SYNTHETIC GENE ORDER
 AGAINST THE DNA SEQUENCES IN A COMMON REGULATED PATHOGEN DATABASE  (RPD)
 AND  AGAINST  ALL  ENTRIES  FOUND  IN ONE OR MORE OF THE INTERNATIONALLY
 COORDINATED  SEQUENCE  REFERENCE  DATABANKS   (SUCH   AS   NCBI/GENBANK,
 EBI/EMBL, OR DDBJ). THE RPD SHALL INCLUDE DATA FROM ALL ORGANISMS ON THE
 FEDERAL  HHS AND USDA SELECT AGENTS AND TOXINS LIST, THE AUSTRALIA GROUP
 LIST OF HUMAN AND ANIMAL PATHOGENS AND TOXINS  FOR  EXPORT  CONTROL  AND
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
                                                            LBD04229-01-5
              

 A. 3283                             2
 
 OTHER NATIONAL LISTS OF REGULATED PATHOGENS. AS A BASELINE, GENE SYNTHE-
 SIS PROVIDERS AND MANUFACTURERS OF GENE SYNTHESIS EQUIPMENT SHALL SCREEN
 AGAINST  ALL PATHOGEN AND TOXIN GENES AS SPECIFIED IN THE FEDERAL SELECT
 AGENTS AND TOXINS LIST, THE FEDERAL COMMERCE CONTROL LIST, AND THE EURO-
 PEAN UNION LIST OF DUAL-USE ITEMS;
   (C) TRANSLATE ALL SIX READING FRAMES OF EACH SYNTHETIC GENE ORDERED OR
 REQUESTED  INTO  AN AMINO ACID SEQUENCE. SUCH SEQUENCE SHALL BE SCREENED
 AGAINST THE PROTEIN SEQUENCES DERIVED FROM THE RPD DATABASE DESCRIBED IN
 THIS SUBDIVISION;
   (D) USE AUTOMATED HOMOLOGY SCREENING AS A FILTER TO IDENTIFY  PATHOGEN
 AND TOXIN DNA SEQUENCES. WHEN AUTOMATED SCREENING IDENTIFIES A POTENTIAL
 PATHOGEN  OR  TOXIN  SEQUENCE,  THE  ORDER  SHALL BE REVIEWED BY A HUMAN
 EXPERT USING COMMON SCREENING CRITERIA AND  SHALL  BE  EITHER  ACCEPTED,
 ACCEPTED WITH A REQUIREMENT FOR ADDITIONAL CUSTOMER REVIEW, OR REJECTED;
   (E)  REQUIRE  IDENTIFICATION  DATA  FROM  ALL  POTENTIAL CUSTOMERS FOR
 SYNTHETIC GENES, INCLUDING AT A MINIMUM A SHIPPING ADDRESS,  INSTITUTION
 NAME,  COUNTRY,  TELEPHONE  NUMBER,  AND  EMAIL  ADDRESS. GENE SYNTHESIS
 PROVIDERS SHALL NOT SHIP TO PO BOXES;
   (F) SCREEN POTENTIAL CUSTOMERS AGAINST THE FEDERAL OFFICE  OF  FOREIGN
 ASSETS CONTROL'S SPECIALLY DESIGNATED NATIONALS AND BLOCKED PERSONS LIST
 (SDN),  THE FEDERAL DEPARTMENT OF STATE'S DEBARRED LIST, AND THE FEDERAL
 BUREAU OF INDUSTRY AND SECURITY'S DENIED PERSONS LIST, ENTITY LIST,  AND
 UNVERIFIED LIST;
   (G)  REQUIRE ADDITIONAL CUSTOMER SCREENING BEFORE ACCEPTING ORDERS FOR
 DNA SEQUENCES FROM REGULATED PATHOGENS OR TOXINS. ALTHOUGH  THE  FEDERAL
 SELECT  AGENT REGULATIONS AND THE EUROPEAN COMMISSION REGULATIONS DO NOT
 RESTRICT ACCESS TO ALL SELECT AGENT GENES, GENE SYNTHESIS PROVIDERS  AND
 MANUFACTURERS  OF GENE SYNTHESIS EQUIPMENT SHALL SUPPLY GENES FROM REGU-
 LATED PATHOGENS ONLY TO RESEARCHERS IN BONA  FIDE  GOVERNMENT  LABORATO-
 RIES,  UNIVERSITIES,  NON-PROFIT  RESEARCH  INSTITUTIONS,  OR INDUSTRIAL
 LABORATORIES DEMONSTRABLY ENGAGED IN  LEGITIMATE  RESEARCH.    CUSTOMERS
 ORDERING  SEQUENCES  UNIQUE  TO  ORGANISMS  LISTED IN THE FEDERAL SELECT
 AGENT OR THE UNITED STATES COMMERCE CONTROL LIST THAT ENDOW  OR  ENHANCE
 PATHOGENICITY SHALL PROVIDE A WRITTEN DESCRIPTION OF THE INTENDED USE OF
 THE  SYNTHETIC  PRODUCT.  GENE  SYNTHESIS PROVIDERS AND MANUFACTURERS OF
 GENE SYNTHESIS EQUIPMENT SHALL VERIFY INDEPENDENTLY: (I) THE IDENTITY OF
 THE POTENTIAL CUSTOMER AND PURCHASING ORGANIZATION; AND  (II)  THAT  THE
 DESCRIBED USE IS CONSISTENT WITH THE ACTIVITIES OF THE PURCHASING ORGAN-
 IZATION;
   (H)  USE  THE  CURRENT  RECOMMENDATIONS  FROM  THE FEDERAL CENTERS FOR
 DISEASE CONTROL AND PREVENTION OR THE UNITED STATES DEPARTMENT OF  AGRI-
 CULTURE  TO  DETERMINE WHICH DNA SEQUENCES ARE SELECT AGENTS AS RECOMBI-
 NANT DNA FRAGMENTS. GENE SYNTHESIS PROVIDERS AND MANUFACTURERS  OF  GENE
 SYNTHESIS  EQUIPMENT  SHALL SUPPLY GENES WITH SUCH SEQUENCES ONLY IF THE
 SUPPLIER AND THE CUSTOMER ARE ABLE TO COMPLY WITH ALL SELECT AGENT REGU-
 LATIONS APPLICABLE TO SUCH GENE;
   (I) IN GENERAL, ONLY SELL DNA OR FRAGMENTS OF REGULATED  PATHOGENS  TO
 BONA  FIDE END-USERS. GENE SYNTHESIS PROVIDERS AND MANUFACTURERS OF GENE
 SYNTHESIS EQUIPMENT SHALL NOT SELL OR SHIP SUCH MATERIAL TO DISTRIBUTORS
 OR OTHER RESELLERS, UNLESS SUCH COMPANIES IDENTIFY THE END-USER  RECEIV-
 ING THE PRODUCTS AND DEMONSTRATE THEIR COMPLIANCE WITH EVERY REQUIREMENT
 OTHERWISE APPLICABLE TO SUCH END-USER;
   (J) RETAIN RECORDS OF EVERY GENE SYNTHESIZED AND DELIVERED FOR A MINI-
 MUM  OF  EIGHT  YEARS  AFTER SHIPPING, INCLUDING AT LEAST THE FOLLOWING:
 (I) THE SYNTHETIC DNA SEQUENCE; (II) THE  VECTOR  (IF  APPLICABLE);  AND
 (III) THE RECIPIENT'S IDENTITY AND SHIPPING ADDRESS;
 A. 3283                             3
 
   (K)  RETAIN  RECORDS  OF  EVERY  GENE SEQUENCE SCREENING RESULT FOR AT
 LEAST EIGHT YEARS;
   (L)  RESERVE THE RIGHT TO REFUSE TO FILL ANY ORDER AND TO NOTIFY OTHER
 GENE SYNTHESIS PROVIDERS AND MANUFACTURERS OF GENE  SYNTHESIS  EQUIPMENT
 AND AUTHORITIES UPON IDENTIFYING POTENTIALLY PROBLEMATIC ORDERS;
   (M)  ESTABLISH  AN UP-TO-DATE CONTACT LIST OF NATIONAL LAW ENFORCEMENT
 AGENCIES WITH WHOM TO SHARE INFORMATION AND REPORT ANY POTENTIAL  MISUSE
 OF SYNTHETIC GENES;
   (N) REPORT ANY REQUEST FOR A GENE ASSOCIATED WITH THE PATHOGENICITY OF
 AN  ORGANISM  RECEIVED FROM A SUSPICIOUS POTENTIAL CUSTOMER OR POTENTIAL
 CUSTOMER FAILING TO ESTABLISH THEIR LEGITIMACY TO LAW ENFORCEMENT  OFFI-
 CIALS; AND
   (O)  SYNTHESIZE  GENE  SEQUENCES  UNIQUE  TO  AND DERIVED FROM VARIOLA
 (SMALLPOX) VIRUS DNA ONLY IN ADHERENCE WITH  GUIDELINES  ESTABLISHED  BY
 THE  WORLD  HEALTH  ORGANIZATION'S  ADVISORY COMMITTEE FOR VARIOLA VIRUS
 RESEARCH.
   § 3. This act shall take effect immediately.

                             
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                  3283--A
 
                        2025-2026 Regular Sessions
 
                           I N  A S S E M B L Y
 
                             January 27, 2025
                                ___________
 
 Introduced  by M. of A. BORES -- read once and referred to the Committee
   on Health -- committee discharged, bill amended, ordered reprinted  as
   amended and recommitted to said committee
 
 AN  ACT  to amend the public health law, in relation to the operation of
   gene synthesis providers and manufacturers of gene synthesis equipment

   THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND  ASSEM-
 BLY, DO ENACT AS FOLLOWS:
 
   Section  1.  Short  title. This act shall be known and may be cited as
 the "bioterrorism prevention act".
   § 2. The public health law is amended by adding a new article 32-B  to
 read as follows:
                               ARTICLE 32-B
                            GENE SYNTHESIS LABS
 SECTION 3230. OPERATION OF GENE SYNTHESIS PROVIDERS AND MANUFACTURERS OF
                 GENE SYNTHESIS EQUIPMENT.
   §  3230.  OPERATION  OF  GENE SYNTHESIS PROVIDERS AND MANUFACTURERS OF
 GENE SYNTHESIS EQUIPMENT.  ANY GENE SYNTHESIS PROVIDER  OR  MANUFACTURER
 OF  GENE  SYNTHESIS  EQUIPMENT  IN THE STATE SHALL OPERATE IN ACCORDANCE
 WITH INTERNATIONAL GENE SYNTHESIS CONSORTIUM PROTOCOLS AS ENUMERATED  IN
 THE MOST RECENT VERSION OF THE HARMONIZED SCREENING PROTOCOL.
   § 3. This act shall take effect immediately.
 
 
 
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
                                                            LBD04229-02-5



              

                             
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                  3283--B
 
                        2025-2026 Regular Sessions
 
                           I N  A S S E M B L Y
 
                             January 27, 2025
                                ___________
 
 Introduced  by M. of A. BORES -- read once and referred to the Committee
   on Health -- committee discharged, bill amended, ordered reprinted  as
   amended  and  recommitted  to  said  committee  --  recommitted to the
   Committee on Health in accordance with Assembly  Rule  3,  sec.  2  --
   committee  discharged,  bill amended, ordered reprinted as amended and
   recommitted to said committee
 
 AN ACT to amend the public health law, in relation to the  operation  of
   gene synthesis providers and manufacturers of gene synthesis equipment
 
   THE  PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
 BLY, DO ENACT AS FOLLOWS:
 
   Section 1. Short title. This act shall be known and may  be  cited  as
 the "bioterrorism prevention act".
   §  2. The public health law is amended by adding a new article 32-B to
 read as follows:
                               ARTICLE 32-B
                            GENE SYNTHESIS LABS
 SECTION 3230. OPERATION OF GENE SYNTHESIS PROVIDERS AND MANUFACTURERS OF
                 GENE SYNTHESIS EQUIPMENT.
   § 3230. OPERATION OF GENE SYNTHESIS  PROVIDERS  AND  MANUFACTURERS  OF
 GENE  SYNTHESIS EQUIPMENT.   ANY GENE SYNTHESIS PROVIDER OR MANUFACTURER
 OF LABORATORY EQUIPMENT INTENDED FOR USE BY A  GENE  SYNTHESIS  PROVIDER
 SHALL  OPERATE  IN  ACCORDANCE  WITH RULES AND REGULATIONS ISSUED BY THE
 DEPARTMENT. THE DEPARTMENT SHALL  UTILIZE  GENERALLY  ACCEPTED  INDUSTRY
 STANDARDS  AND TAKE INTO CONSIDERATION RECOMMENDATIONS AND PROTOCOLS SET
 BY THE INTERNATIONAL GENE  SYNTHESIS  CONSORTIUM  AND/OR  OTHER  SIMILAR
 NATIONALLY OR INTERNATIONALLY RECOGNIZED RELEVANT ORGANIZATIONS TO DRAFT
 SUCH  RULES  AND  REGULATIONS.  FOR  THE  PURPOSE OF THIS SECTION, "GENE
 SYNTHESIS PROVIDER" SHALL MEAN ANY ENTITY THAT SYNTHESIZES AND  DISTRIB-
 UTES SYNTHETIC NUCLEIC ACIDS TO A CUSTOMER OR TO A DISTRIBUTOR.
   § 3. This act shall take effect immediately.
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
                                                            LBD04229-04-6