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  • PART I ADMINISTRATION OF THE GOVERNMENT
  • TITLE XVI PUBLIC HEALTH
  • CHAPTER 111L BIOTECHNOLOGY
  • Section 10 Enforcement of chapter; procedure for adoption, amendment or repeal of regulations; certificate of registration for research institutions

Section 10. (a) The department shall enforce this chapter and may adopt regulations, in a manner consistent with this chapter, and with the advice of the biomedical research advisory council, relating to the administration and enforcement of this chapter; but the department shall not propose or implement any regulation or rule which would have the purpose or effect of inhibiting, delaying or otherwise obstructing research or clinical applications proposed or undertaken pursuant to subsection (a) or (b) of section 3. The regulations shall be consistent with the findings and declarations of the general court as stated in section 1.

(b) Before the adoption, amendment or repeal of any regulation pursuant to this chapter, the department shall hold a public hearing in accordance with chapter 30A. Notwithstanding said chapter 30A, at least 90 days before a public hearing the department shall: (i) publish notice of its proposed action in at least 1 major newspaper in the Boston, Worcester, and Springfield metropolitan areas, in at least 1 biotechnology newspaper or trade journal, in at least 1 medical journal published in the commonwealth, and in such additional newspapers or trade, industry, or professional publications as the department may select; (ii) notify any institution holding a certificate of registration issued pursuant to this chapter; (iii) notify any person, institution or group which has filed a written request pursuant to this section for notice of any regulatory proceeding; such a request shall be renewed at least annually, and delivering or mailing a copy of the notice to the last known address of the person, institution or group required to be notified shall constitute sufficient notice under this section; (iv) file a copy of the notice with the joint committee on economic development and emerging technologies and the joint committee on state administration and regulatory oversight; and (v) file a copy of the notice with the state secretary. The notice required by this section shall refer to the statutory authority pursuant to which the regulatory action is predicated; and shall specify the date, time and place of the public hearing, the manner in which data, views or arguments may be submitted to the agency by any interested person, institution, or group, and the express terms or the substance of the proposed regulations.

(c) No regulation promulgated by the department pursuant to this chapter shall be exempt from the hearing requirement or be considered an emergency regulation pursuant to chapter 30A.

(d) The joint committee on state administration and regulatory oversight of the general court, in this subsection called the committee, shall have authority to review regulations proposed or adopted pursuant to this chapter. The committee shall consult with the joint committee on economic development and emerging technologies in performing this review. The committee may hold public hearings concerning a proposed or existing regulation and may submit to the department comments concerning the merit and appropriateness of the regulations to be promulgated and an opinion whether the regulations are authorized by, and consistent with, this chapter. The department shall respond in writing within 10 days to the committee’s written questions relevant to the committee’s review of a proposed or existing regulation. The department shall provide to the committee, without charge, copies of all public records in the agency’s custody relating to the regulation or action in question within 10 days of a request by the committee. The committee may issue a report with proposed changes to a proposed or existing regulation and shall transmit this report to the department. If the department does not adopt the proposed changes contained in the committee’s report, the department shall notify the committee in writing of the reasons why it did not adopt the changes either at the time it adopts a proposed regulation or within 21 days of receiving the committee’s report on an existing regulation.

(e) The superior court department of the trial court shall have jurisdiction to consider any claim challenging the validity of a regulation issued pursuant to this section. Any institution holding a certificate of registration to conduct research pursuant to this chapter, and aggrieved by a regulation promulgated by the department, may bring a civil action presenting its claim. In any such civil action, in determining whether a preliminary injunction shall issue, the court shall consider any regulation that would have the effect of prohibiting or discontinuing research authorized pursuant to this chapter to be an irreparable injury to the institution bringing the claim.

(f) The department shall issue a certificate of registration authorizing an institution to conduct human embryonic stem cell research within 30 days after submission of an application from the applicant institution, if the institution: (i) pays a fee of not more than $200 to the department; and (ii) provides documentation to the department demonstrating that the institution has an institutional review board or provides a copy of a contract between the institution and either a private or public institutional review board which shall review the institution’s experimentation, study and procedures involving human embryonic stem cell research. Any institution which submits an application and meets the requirements for a certificate of registration pursuant to this section shall not have the certificate of registration unreasonably withheld. A certificate may be withheld if the department determines that the applicant institution has violated subsection (m).

(g) No research authorized pursuant to subsection (b) of section 3 shall be conducted at any institution that does not have a valid certificate of registration issued pursuant to this section.

(h) All certificates of registration issued in accordance with this section shall be valid for a term of 3 years from the date of issuance. The department shall notify all holders of certificates of registration under this section at least 60 days before the expiration of the certificate of registration. If an institution that is issued a certificate of registration under this chapter makes timely and sufficient application for a renewal, its certificate of registration shall not expire until its application has been finally determined by the department. Before the assessment of a civil administrative penalty pursuant to this section, the department shall notify the holder of the certificate of registration that it has 90 days after the date of expiration within which to submit an application for renewal during which time the department shall waive any applicable penalties pursuant to this subsection.

(i) An institution holding a certificate of registration pursuant to subsection (f) shall submit an annual report to the department providing a summary of the research approved during each calendar year and a statement representing that the research was reviewed in accordance with this chapter, if applicable.

(j) The department shall certify its receipt of annual reports from institutions holding a certificate of registration pursuant to subsection (f).

(k) The department shall keep an official record of the names of all institutions holding a certificate of registration and of all money received and disbursed by it. A duplicate of this record shall be open for public inspection in the office of the state secretary.

(l) The department shall keep an official record of all persons convicted of violating subsection (a), (b) or (c) of section 8. The department shall annually send notice of the names of those violators to all institutions issued a certificate of registration under subsection (f). No such institution shall knowingly employ a person whom the department has identified as having been convicted of a violation of said subsection (a), (b) or (c) of said section 8.

(m) The department shall revoke any certificate of registration, shall not renew such certificate and shall deny any future application for a certificate of registration for any institution that knowingly and willfully permits or assists a violation of subsection (a) of section 8, whether or not the violation is committed by an employee of that institution.

(n) (1) The department may discipline an institution conducting research pursuant to this chapter if it is determined, after an opportunity for an adjudicatory proceeding conducted pursuant to chapter 30A, that the institution has:

(i) violated subsection (b) of section 3;

(ii) violated section 4;

(iii) knowingly and willfully permitted or assisted a violation of subsection (b) or (c) of section 8;

(iv) knowingly violated subsection (f) of this section, if applicable;

(v) failed to submit an annual report to the department pursuant to subsection (i);

(vi) employed a person identified in the annual notice by the department pursuant to subsection (l); or

(vii) knowingly implemented a decision by an institutional review board to authorize research prohibited by this chapter.

(2) The department may, after an opportunity for an adjudicatory proceeding conducted pursuant to chapter 30A, upon determination that an institution conducting research pursuant to this chapter has violated this subsection undertake the following actions:

(i) for the violation of clause (iii) of paragraph (1), revoke or refuse to renew such certificate of registration or assess upon the holder a civil administrative penalty not to exceed $250,000 and may require the holder to submit to additional oversight as a condition or retention, or future consideration of reinstatement of the certificate of registration;

(ii) for a violation of clause (i), (ii), (iv), (vi) or (vii) of paragraph (1), assess upon the holder a civil administrative penalty not to exceed $100,000; or

(iii) for a first violation of clause (v) of paragraph (1) censure a holder; and for each subsequent violation of said clause (v) of said paragraph (1), suspend such certificate of registration until compliance with subsection (i), and impose a civil administrative penalty, as determined by the department not to exceed $1,000.

(3) An institution sanctioned under this subsection may be subject to such other sanctions or punishment as may be provided by law. The department shall promulgate such rules and regulations not inconsistent with chapter 30A and this chapter as necessary for the filing of charges and the conduct of proceedings.