430 ILCS 95/ Release of Genetically Engineered Organisms Act.

(430 ILCS 95/0.01) (from Ch. 111 1/2, par. 7600)

Sec. 0.01. Short title. This Act may be cited as the Release of Genetically Engineered Organisms Act.

(Source: P.A. 86-1324.)

(430 ILCS 95/1) (from Ch. 111 1/2, par. 7601)

Sec. 1. Definitions. As used in this Act:

(a) "Confidential information" means information entitled to confidential treatment under paragraphs (1) or (2) of subsection (a) of Section 7.

(b) "Coordinated framework" means the coordinated framework for regulation of biotechnology set forth in Title 7, Part 340 of the Code of Federal Regulations, as now or hereafter amended.

(c) "Department" means the Illinois Department of Agriculture or the Illinois Environmental Protection Agency.

(d) "Federal regulator" means a federal agency or a designee of a federal agency which is responsible for regulating a release into the environment under the coordinated framework.

(e) "Regulated release" means a release into the environment for which the coordinated framework requires that the person proposing to commence the release into the environment do one or more of the following:

(1) Notify a federal regulator of the release into the environment.

(2) Secure the approval of or a permit or license from a federal regulator before commencing the release into the environment.

(3) Secure a determination by a federal regulator of the need for notification, approval, licensing or issuance of a permit by the federal regulator if the determination is part of a procedure specified in the coordinated framework.

(f) "Release into the environment" means the intentional introduction or use in this State beyond the de minimis level, of an organism or pathogen anywhere except within an indoor facility which is designed to physically contain the organism or pathogen, including a laboratory, greenhouse, growth chamber or fermenter.

(g) "Reviewing Department" means the Department designated in Section 2 to review a regulated release.

(h) "Toxic Substances Control Act" means the federal Toxic Substances Control Act, 15 USC 2601 et seq., as now or hereafter amended.

(i) "Federal Freedom of Information Act" means the federal Freedom of Information Act, 5 USC 552, as now or hereafter amended.

(Source: P.A. 86-306.)

(430 ILCS 95/2) (from Ch. 111 1/2, par. 7602)

Sec. 2. Department Designation.

(a) The Illinois Environmental Protection Agency shall be the reviewing Department for any regulated release subject to the Toxic Substances Control Act.

(b) The Department of Agriculture shall be the reviewing Department for any regulated release subject to any federal requirement in the coordinated framework, except a requirement under the Toxic Substances Control Act.

(c) If a regulated release is subject to the Toxic Substances Control Act and any other federal requirement in the coordinated framework, both Departments shall be reviewing Departments and shall enter into a memorandum of understanding designating one of them to be the lead reviewing Department.

(Source: P.A. 86-306.)

(430 ILCS 95/3) (from Ch. 111 1/2, par. 7603)

Sec. 3. Notification.

(a) Except as provided under Section 8, no person may commence a regulated release unless the person provides to the reviewing Department for that regulated release all of the following information within 7 days after the person submits or should have submitted the information specified in paragraph (1) of this subsection (a) to a federal regulator, whichever is sooner:

(1) A copy of all information which the person is required to submit to the federal regulator and which is not confidential information.

(2) A summary of any confidential information which the person submits or is required to submit to a federal regulator. The summary shall be sufficient to enable the reviewing Department to prepare the comment authorized under Section 5 and to provide information to the public and shall have minimal extraneous and irrelevant information.

(b) Notwithstanding subsection (a) of Section 7, if either Department receives information under this subsection, it shall provide a copy of such information to the other Department.

(Source: P.A. 91-357, eff. 7-29-99.)

(430 ILCS 95/4) (from Ch. 111 1/2, par. 7604)

Sec. 4. No less than 10 days prior to any regulated release, the person proposing to commence such release shall send written notice giving summary details of such proposed release to the chief executive officer of the county in which the release is proposed and to the mayor or president of any municipality in such county if the release is within its corporate limits. A copy of the written notice shall be sent to the reviewing Department at the same time as such notice is sent to the appropriate local officials.

(Source: P.A. 86-306.)

(430 ILCS 95/5) (from Ch. 111 1/2, par. 7605)

Sec. 5. Comment. The reviewing Department may prepare a formal comment on the regulated release for submission to the federal regulator for that regulated release. The reviewing Department shall submit that comment within the time established by the federal regulator for that regulated release. The comment shall address the criteria for notification or the granting of approval of a permit or a license under the applicable requirement in the coordinated framework and for the protection of the public health and the environment. To assist in the preparation of a comment, the reviewing Department may do any of the following:

(a) Hold an informational meeting on the proposed regulated release.

(b) Provide an opportunity for the public to comment on the proposed regulated release.

(c) Conduct a technical review of the proposed regulated release.

(d) Seek the assistance of the faculty and academic staff of an Illinois public college or university or the Department of Public Health in reviewing the proposed regulated release.

(Source: P.A. 86-306.)

(430 ILCS 95/6) (from Ch. 111 1/2, par. 7606)

Sec. 6. Memorandum Of Understanding. Within 6 months after the effective date of this Act, the Illinois Environmental Protection Agency shall enter into a memorandum of understanding with the Illinois Department of Agriculture setting forth the procedures and responsibilities of the Departments in the administration of this Act. The memorandum shall establish procedures that minimize the duplication of effort by the Departments and the person providing information under Section 3.

(Source: P.A. 86-306.)

(430 ILCS 95/7) (from Ch. 111 1/2, par. 7607)

Sec. 7. Confidential Treatment Of Records. (a) Except as provided in subsections (b) and (c), the Departments shall keep confidential any information received under this Act or if the person submitting the information notifies the Departments that:

(1) The federal regulator to which the information has been submitted has determined that the information is entitled to confidential treatment and is not subject to public disclosure under the federal Freedom of Information Act or under the coordinated framework, or

(2) The person submitting the information to the Departments has submitted a claim to the federal regulator that the information is entitled to confidential treatment under the federal Freedom of Information Act or under the coordinated framework, and the federal regulator has not made a determination on the claim.

(b) Subsection (a) shall not prevent the Departments from exchanging information under subsection (b) of Section 3 or from using the information for the purposes of subsections (c) or (d) of Section 5, subject to the requirements of subsection (d) of this Section. Any person receiving such information is subject to the penalty specified under subsection (b) of Section 10 for the unauthorized release of such information.

(c) The Departments shall allow public access to any information which has been granted confidentiality under subsection (a) if any of the following occurs:

(1) The person providing the information to the Departments expressly agrees in writing to the public access to the information.

(2) After information has been granted confidentiality under paragraph (2) of subsection (a), the federal regulator makes a determination that the information is not entitled to confidential treatment under the federal Freedom of Information Act or under the coordinated framework.

(d) (1) The Departments shall establish procedures to protect information required to be kept confidential under subsection (a). Under the procedure, the Departments may not submit any information under subsection (c) or (d) of Section 5 to any person who is not an employee of either of the Departments unless that person has signed an agreement which satisfies the requirements of paragraph (2) of this subsection (d).

(2) Any agreement under paragraph (1) of this subsection (d) shall provide that information which is the subject of the agreement is subject to confidential treatment, shall prohibit the release or sharing of the information which any other person except at the direction of the reviewing Department and in compliance with this Act, shall acknowledge the penalties in the Illinois Trade Secrets Act, as now or hereafter amended, and any other applicable State law identified by the Departments for the unauthorized disclosure of the information and shall contain a statement that the person receiving the information, any member of his or her immediate family or any organization with which he or she is associated has no substantial financial interest in the regulated release which is the subject of the information. Any person submitting the information under Sections 3 or 5 may waive any of the requirements under this paragraph.

(Source: P.A. 86-306.)

(430 ILCS 95/8) (from Ch. 111 1/2, par. 7608)

Sec. 8. Exemptions. (a) This Act does not apply to any drug, cosmetic, medical device or biological product which is intended for human use and regulated under the Federal Food, Drug and Cosmetic Act, 21 USC 301, et seq., as now or hereafter amended or under 42 USC 262, as now or hereafter amended.

(b) A reviewing department may waive part or all of the requirements under Section 3 for a specified regulated release if the reviewing Department determines that the satisfaction of that requirement is not necessary to protect the public health or the environment.

(c) A reviewing Department may exempt a class of regulated releases from part or all of a requirement under Section 3 if the Department determines that the satisfaction of that requirement or part thereof is not necessary to protect the public health or the environment.

(Source: P.A. 86-306.)

(430 ILCS 95/9) (from Ch. 111 1/2, par. 7609)

Sec. 9. Enforcement. The Attorney General shall enforce Sections 3 and 7. Actions to enforce this Act by injunctive and any other relief appropriate for enforcement may be filed in the circuit court in Sangamon County or the county where a violation occurred in whole or in part. In an enforcement action under this Act, if it is determined that a person commenced a regulated release and did not comply with Section 3, the court shall enter an injunction directing the person to cease the regulated release.

(Source: P.A. 86-306.)

(430 ILCS 95/10) (from Ch. 111 1/2, par. 7610)

Sec. 10. Penalties. (a) Any person who violates Section 3 prior to commencing the regulated release is guilty of a petty offense. Any person who violates Section 3 after commencing the regulated release is guilty of a business offense and may be fined an amount not to exceed $25,000 for each violation. Each day of continued violation is a separate offense.

(b) Any person who intentionally violates Section 3 after commencing a regulated release is guilty of a Class A misdemeanor and may be fined an amount not to exceed $25,000. A person who commits a second or subsequent violation under this subsection (b) is guilty of a Class A misdemeanor and may be fined an amount not to exceed $50,000. Each day of continued violation is a separate offense.

(c) Any person who intentionally violates any requirement under subsections (a) or (b) of Section 7 is guilty of a Class B misdemeanor and may be fined an amount not to exceed $50,000.

(d) As used in this Section, a person acts intentionally to accomplish a result or engage in conduct when his conscious objective or purpose is to accomplish that result or engage in that conduct.

(e) Subsections (a) and (b) do not apply to any person who provides the information required under Section 3 to the Departments.

(Source: P.A. 86-306.)

(430 ILCS 95/11) (from Ch. 111 1/2, par. 7611)

Sec. 11. Relation To Other Laws. The authority, power and remedies provided in this Act are in addition to any authority, power or remedy provided in any other Act or law.

(Source: P.A. 86-306.)