146.60(6)(c)2. 2. After information has been granted confidentiality under par. (a) 2., the federal regulator makes a determination that the information is not entitled to confidential treatment under 5 USC 552 or under the coordinated framework.

146.60(6)(c)3. 3. Either of the departments determines that:

146.60(6)(c)3.a. a. The person providing the information to the departments has not submitted that information under par. (a) or a claim under par. (a) 2. to the federal regulator; or

146.60(6)(c)3.b. b. The federal regulator to which the information has been submitted has determined that the information is not entitled to confidential treatment and is subject to public disclosure under 5 USC 552 or under the coordinated framework.

146.60(6)(d)1.1. The departments shall establish procedures to protect information required to be kept confidential under par. (a). Under the procedure, the departments may not submit any information under sub. (4) (d) or (e) 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 subd. 2.

146.60(6)(d)2. 2. The agreement required under subd. 1. 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 with any other person except at the direction of the reviewing department and in compliance with this section, shall acknowledge the penalties in sub. (9), s. 134.90 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 sub. (3) or (4) may waive any of the requirements under this subdivision.

146.60(7)(a)1. 1. Drug.

146.60(7)(a)2. 2. Cosmetic.

146.60(7)(a)3. 3. Medical device.

146.60(7)(a)4. 4. Biological product.

146.60(7)(b) (b) A reviewing department may waive part or all of the requirements under sub. (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.

146.60(7)(c) (c) A reviewing department may exempt a class of regulated releases from part or all of any requirement under sub. (3) if the department determines that the satisfaction of that requirement or part of a requirement is not necessary to protect the public health or the environment.

146.60(8) (8) Enforcement. The attorney general shall enforce subs. (3) and (6). The circuit court for Dane County or for the county where a violation occurred in whole or in part has jurisdiction to enforce this section by injunctive and other relief appropriate for enforcement. In an enforcement action under this section, if it is determined that a person commenced a regulated release and did not comply with sub. (3), the court shall issue an injunction directing the person to prevent or terminate the regulated release.

146.60(9)(a)(a) Any person who fails to submit the information required under sub. (3) and has not commenced a regulated release shall forfeit not more than $100 for each violation. Any person who commences or continues a regulated release without having submitted the information required under sub. (3) shall forfeit not less than $10 nor more than $25,000 for each violation. Each day of continued violation under this paragraph is a separate offense.

146.60(9)(ag) (ag) Any person who intentionally violates sub. (3) after commencing a regulated release shall be fined not less than $100 nor more than $25,000 or imprisoned for not more than one year in the county jail or both.

146.60(9)(b) (b) Any person who intentionally violates any requirement under sub. (6) (a) or (b) shall be fined not less than $50 nor more than $50,000 or imprisoned for not less than one month nor more than 6 months or both.

146.60(10) (10) Relation to other laws. The authority, power and remedies provided in this section are in addition to any authority, power or remedy provided in any other statutes or provided at common law.