HB0476 95TH GENERAL ASSEMBLY

LRB095 07298 RAS 27437 b

95TH GENERAL ASSEMBLY
State of Illinois
2007 and 2008
HB0476

Introduced 2/1/2007, by Rep. Mary E. Flowers

SYNOPSIS AS INTRODUCED:

New Act
5 ILCS 140/7	from Ch. 116, par. 207

Creates the Safe Cosmetics Act. Provides that beginning January 1, 2008, the manufacturer of any cosmetic product subject to regulation by the federal Food and Drug Administration that is sold in this State shall provide the Department of Public Health with a complete and accurate list of its cosmetic products that, as of the date of submission, are sold in the State and that contain any ingredient that is a chemical identified as causing cancer or reproductive toxicity. Provides that the Department may conduct investigations of cosmetic products that contain chemicals identified as causing cancer or reproductive toxicity or other ingredients of concern in order to determine potential health effects of exposure to such ingredients and may refer its findings to the Attorney General and the federal Food and Drug Administration for possible enforcement action pursuant to the Act and the federal Food, Drug, and Cosmetic Act. Amends the Freedom of Information Act to exempt certain information submitted to the Department pursuant to the Safe Cosmetics Act concerning cosmetic ingredients considered to be a trade secret. Effective immediately.

FISCAL NOTE ACT MAY APPLY

A BILL FOR

AN ACT concerning regulation.

Be it enacted by the People of the State of Illinois, represented in the General Assembly:

Section 1. Short title. This Act may be cited as the Safe Cosmetics Act.

Section 5. Findings. The General Assembly finds each of the following:

(1) Independent testing in the United States and the European Union has determined that some cosmetic products contain substances known or suspected to cause cancer and reproductive toxicity that can harm the mother, fetus, and nursing children.

(2) Neither the federal Food and Drug Administration (FDA) nor the Department of Public Health require premarket safety testing, review, or approval of cosmetic products. According to the FDA, the regulatory requirements governing the sale of cosmetics are not as stringent as those that apply to other FDA-regulated products.

(3) Under the federal Food, Drug, and Cosmetic Act, cosmetics and their ingredients are not required to be approved before they are sold to the public and the FDA does not have the authority to require manufacturers to file health and safety data on cosmetic ingredients or to order a recall of a dangerous cosmetic product.

(4) Under the Illinois Food, Drug and Cosmetic Act, the Department of Public Health has no authority to identify, review, or regulate ingredients in cosmetic products that may cause chronic health effects, such as cancer and reproductive toxicity.

(5) Cosmetic products are most heavily used by women of childbearing age, increasing the likelihood of exposing mothers, fetuses, and nursing children to substances that can cause cancer and reproductive toxicity.

(6) Beauty care workers, including cosmetologists and manicurists, are most exposed to the potentially harmful effects of carcinogens and reproductive toxins in cosmetics. The majority of cosmetologists and manicurists working in this State are women and minorities.

(7) Federal law exempts chemicals used as fragrances or flavoring from being identified as ingredients on the labels of cosmetic products. Federal law also does not require any ingredient labeling on cosmetic products sold for commercial use, thereby denying any information on ingredients to beauty care workers.

(8) Alternatives to substances that cause cancer or reproductive toxicity are readily available for use in cosmetic products. A number of manufacturers, including both small domestic producers and large multinational corporations, have eliminated substances that cause cancer or reproductive toxicity from their products.

(9) Given (i) the presence of substances in cosmetic products that cause cancer and reproductive toxicity, (ii) the heavy use of these products by women of childbearing age, (iii) the significant exposure to these products in occupational settings such as nail and beauty salons, (iv) the adverse impacts of these substances on human health,(v) the inadequate information about the presence of these substances in products or the extent of their impacts, and (vi) the availability of alternatives to the use of these substances, it is in the interest of the people of this State to take steps to ensure that cosmetic products sold and used in the State can be used safely.

Section 10. Definitions. In this Act:

"Authoritative body" means any agency or formally organized program or group recognized by the Department as being authoritative for the purpose of identifying chemicals that cause cancer or reproductive toxicity.

"Chemical identified as causing cancer or reproductive toxicity" means a chemical identified by the Department or identified by an authoritative body as any of the following:

(1) A substance listed as known or reasonably anticipated to be a human carcinogen in a national toxicology report on carcinogens.

(2) A substance given an overall carcinogenicity evaluation of Group 1, Group 2A, or Group 2B by the International Agency for Research on Cancer.

(3) A substance identified as a Group A, Group B1, or Group B2 carcinogen, or as a known or likely carcinogen by the United States Environmental Protection Agency.

(4) A substance identified as having some or clear evidence of adverse developmental, male reproductive, or female reproductive toxicity effects in a report by an expert panel of the National Toxicology Program's Center for the Evaluation of Risks to Human Reproduction.

"Department" means the Department of Public Health.

"Ingredient" means any single chemical entity or mixture used as a component in the manufacture of a cosmetic product. "Ingredient" does not include any incidental ingredient that is present in a cosmetic at insignificant levels and that has no technical or functional effect in the cosmetic, including any of the following:

(1) Substances that have no technical or functional effect in the cosmetic but are present by reason of having been incorporated into the cosmetic as an ingredient of another cosmetic ingredient.

(2) Processing aids that are substances that are added to a cosmetic during the processing of the cosmetic but are removed from the cosmetic in accordance with good manufacturing practices before it is packaged in its finished form.

(3) Processing aids that are substances that are added to a cosmetic during processing for their technical or functional effect in the processing, are converted to substances the same as constituents of declared ingredients, and do not significantly increase the concentration of those constituents.

(4) Processing aids that are substances that are added to a cosmetic during the processing of such cosmetic for their technical and functional effect in the processing, but are present in the finished cosmetic at insignificant levels and do not have any technical or functional effect in that cosmetic.

"Manufacturer" means any person whose name appears on the label of a cosmetic product pursuant to the requirements of Section 701.12 of Title 21 of the Code of Federal Regulations.

Section 15. Manufacturer's product list required.

(a) Beginning January 1, 2008, the manufacturer of any cosmetic product subject to regulation by the federal Food and Drug Administration that is sold in this State shall, on a schedule and in electronic or other format, as determined by the Department, provide the Department with a complete and accurate list of its cosmetic products that, as of the date of submission, are sold in this State and that contain any ingredient that is a chemical identified as causing cancer or reproductive toxicity, including any chemical that meets either of the following conditions:

(1) A chemical contained in the product for purposes of fragrance or flavoring.

(2) A chemical identified by the phrase "and other ingredients" and determined to be a trade secret pursuant to the procedure established in Part 20 and Section 720.8 of Part 720 of Title 21 of the Code of Federal Regulations.

(b) Any ingredient identified pursuant to subsection (a) shall be considered to be a trade secret and shall be treated by the Department in a manner consistent with the requirements of Part 20 and Part 720 of Title 21 of the Code of Federal Regulations. Any ingredients considered to be a trade secret shall not be subject to the Freedom of Information Act for the purposes of this Section.

(c) Any information submitted pursuant to subsection (a) shall identify each chemical both by name and Chemical Abstract Service number and shall specify the product or products in which the chemical is contained.

(d) If an ingredient identified pursuant to this Section is subsequently removed from the product in which it was contained or is no longer a chemical identified as causing cancer or reproductive toxicity by an authoritative body, the manufacturer of the product containing the ingredient shall submit the new information to the Department. Upon receipt of new information, the Department, after verifying the accuracy of that information, shall revise the manufacturer's information on record with the Department to reflect the new information. The manufacturer shall not be under obligation to submit subsequent information on the presence of the ingredient in the product unless subsequent changes require submittal of the information.

(e) This Section shall not apply to any manufacturer of cosmetic products with annual aggregate sales of cosmetic products, both within and outside of Illinois, of less than $1,000,000, based on the manufacturer's most recent tax year filing.

Section 20. Investigations.

(a) In order to determine potential health effects of exposure to ingredients in cosmetics sold in the State, the Department may conduct an investigation of one or more cosmetic products that contain chemicals identified as causing cancer or reproductive toxicity or other ingredients of concern to the Department.

(b) An investigation conducted pursuant to this Section may include, without limitation a review of available health effects data and studies, worksite health hazard evaluations, epidemiological studies to determine the health effects of exposures to chemicals in various subpopulations, and exposure assessments to determine total exposures to individuals in various settings.

(c) If an investigation is conducted pursuant to this Section, the manufacturer of any product subject to the investigation may submit relevant health effects data and studies to the Department.

(d) In order to further the purposes of an investigation, the Department may require manufacturers of products subject to the investigation to submit to the Department relevant health effects data and studies available to the manufacturer and other available information as requested by the Department, including, but not limited to, the concentration of the chemical in the product, the amount by volume or weight of the product that comprises the average daily application or use, and sales and use data necessary to determine where the product is used in the occupational setting. The Department shall establish reasonable deadlines for the submittal of information required pursuant to this subsection (d). Failure by a manufacturer to submit the information in compliance with the requirements of the Department shall constitute a violation of this Act.

Section 25. CIR Panel review; enforcement.

(a) The General Assembly finds and declares each of the following:

(1) The Cosmetic Ingredient Review (CIR) Panel is a nongovernmental body established and funded by the cosmetics industry to review the safety of cosmetic ingredients.

(2) According to a 2004 analysis of the 2003 CIR Compendium by the Environmental Working Group, 54 cosmetic products violate the CIR's own safe use recommendations to manufacturers by containing an ingredient that the CIR has found is not safe for the specific use indicated on the product's label.

(3) Federal regulations require every ingredient in a cosmetic product and every finished cosmetic product to be adequately substantiated for safety prior to marketing, and state that any ingredient or product whose safety has not been adequately substantiated prior to marketing is misbranded unless it displays a warning statement declaring, "The safety of this product has not been determined.".

(b) The Department may, as early as feasible within existing resources, determine whether the products identified in subdivision (2) of subsection (a) have been adequately substantiated for safety pursuant to Section 740.10 of Title 21 of the Code of Federal Regulations. For any product adequately substantiated for safety, the Department shall determine if the product contains any ingredient that the CIR has found is not safe for the specific use indicated on the product's label.

(c) If the Department finds that a product on a manufacturer's list, which has been submitted to the Department pursuant to Section 15 of this Act, has been adequately substantiated for safety despite containing an ingredient that the CIR has found is not safe for the specific use indicated on the product's label, the Department shall refer its findings to the Attorney General and the federal Food and Drug Administration for possible enforcement action pursuant to this Act and the federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 301 et seq.).

Section 90. The Freedom of Information Act is amended by changing Section 7 as follows:

(5 ILCS 140/7) (from Ch. 116, par. 207)

Sec. 7. Exemptions.

(1) The following shall be exempt from inspection and copying:

(a) Information specifically prohibited from disclosure by federal or State law or rules and regulations adopted under federal or State law.

(b) Information that, if disclosed, would constitute a clearly unwarranted invasion of personal privacy, unless the disclosure is consented to in writing by the individual subjects of the information. The disclosure of information that bears on the public duties of public employees and officials shall not be considered an invasion of personal privacy. Information exempted under this subsection (b) shall include but is not limited to:

(i) files and personal information maintained with respect to clients, patients, residents, students or other individuals receiving social, medical, educational, vocational, financial, supervisory or custodial care or services directly or indirectly from federal agencies or public bodies;

(ii) personnel files and personal information maintained with respect to employees, appointees or elected officials of any public body or applicants for those positions;

(iii) files and personal information maintained with respect to any applicant, registrant or licensee by any public body cooperating with or engaged in professional or occupational registration, licensure or discipline;

(iv) information required of any taxpayer in connection with the assessment or collection of any tax unless disclosure is otherwise required by State statute;

(v) information revealing the identity of persons who file complaints with or provide information to administrative, investigative, law enforcement or penal agencies; provided, however, that identification of witnesses to traffic accidents, traffic accident reports, and rescue reports may be provided by agencies of local government, except in a case for which a criminal investigation is ongoing, without constituting a clearly unwarranted per se invasion of personal privacy under this subsection; and

(vi) the names, addresses, or other personal information of participants and registrants in park district, forest preserve district, and conservation district programs.

(c) Records compiled by any public body for administrative enforcement proceedings and any law enforcement or correctional agency for law enforcement purposes or for internal matters of a public body, but only to the extent that disclosure would:

(i) interfere with pending or actually and reasonably contemplated law enforcement proceedings conducted by any law enforcement or correctional agency;

(ii) interfere with pending administrative enforcement proceedings conducted by any public body;

(iii) deprive a person of a fair trial or an impartial hearing;

(iv) unavoidably disclose the identity of a confidential source or confidential information furnished only by the confidential source;

(v) disclose unique or specialized investigative techniques other than those generally used and known or disclose internal documents of correctional agencies related to detection, observation or investigation of incidents of crime or misconduct;

(vi) constitute an invasion of personal privacy under subsection (b) of this Section;

(vii) endanger the life or physical safety of law enforcement personnel or any other person; or

(viii) obstruct an ongoing criminal investigation.

(d) Criminal history record information maintained by State or local criminal justice agencies, except the following which shall be open for public inspection and copying:

(i) chronologically maintained arrest information, such as traditional arrest logs or blotters;

(ii) the name of a person in the custody of a law enforcement agency and the charges for which that person is being held;

(iii) court records that are public;

(iv) records that are otherwise available under State or local law; or

(v) records in which the requesting party is the individual identified, except as provided under part (vii) of paragraph (c) of subsection (1) of this Section.

"Criminal history record information" means data identifiable to an individual and consisting of descriptions or notations of arrests, detentions, indictments, informations, pre-trial proceedings, trials, or other formal events in the criminal justice system or descriptions or notations of criminal charges (including criminal violations of local municipal ordinances) and the nature of any disposition arising therefrom, including sentencing, court or correctional supervision, rehabilitation and release. The term does not apply to statistical records and reports in which individuals are not identified and from which their identities are not ascertainable, or to information that is for criminal investigative or intelligence purposes.

(e) Records that relate to or affect the security of correctional institutions and detention facilities.

(f) Preliminary drafts, notes, recommendations, memoranda and other records in which opinions are expressed, or policies or actions are formulated, except that a specific record or relevant portion of a record shall not be exempt when the record is publicly cited and identified by the head of the public body. The exemption provided in this paragraph (f) extends to all those records of officers and agencies of the General Assembly that pertain to the preparation of legislative documents.

(g) Trade secrets and commercial or financial information obtained from a person or business where the trade secrets or information are proprietary, privileged or confidential, or where disclosure of the trade secrets or information may cause competitive harm, including:

(i) All information determined to be confidential under Section 4002 of the Technology Advancement and Development Act.

(ii) All trade secrets and commercial or financial information obtained by a public body, including a public pension fund, from a private equity fund or a privately held company within the investment portfolio of a private equity fund as a result of either investing or evaluating a potential investment of public funds in a private equity fund. The exemption contained in this item does not apply to the aggregate financial performance information of a private equity fund, nor to the identity of the fund's managers or general partners. The exemption contained in this item does not apply to the identity of a privately held company within the investment portfolio of a private equity fund, unless the disclosure of the identity of a privately held company may cause competitive harm.

Nothing contained in this paragraph (g) shall be construed to prevent a person or business from consenting to disclosure.

(h) Proposals and bids for any contract, grant, or agreement, including information which if it were disclosed would frustrate procurement or give an advantage to any person proposing to enter into a contractor agreement with the body, until an award or final selection is made. Information prepared by or for the body in preparation of a bid solicitation shall be exempt until an award or final selection is made.

(i) Valuable formulae, computer geographic systems, designs, drawings and research data obtained or produced by any public body when disclosure could reasonably be expected to produce private gain or public loss. The exemption for "computer geographic systems" provided in this paragraph (i) does not extend to requests made by news media as defined in Section 2 of this Act when the requested information is not otherwise exempt and the only purpose of the request is to access and disseminate information regarding the health, safety, welfare, or legal rights of the general public.

(j) Test questions, scoring keys and other examination data used to administer an academic examination or determined the qualifications of an applicant for a license or employment.

(k) Architects' plans, engineers' technical submissions, and other construction related technical documents for projects not constructed or developed in whole or in part with public funds and the same for projects constructed or developed with public funds, but only to the extent that disclosure would compromise security, including but not limited to water treatment facilities, airport facilities, sport stadiums, convention centers, and all government owned, operated, or occupied buildings.

(l) Library circulation and order records identifying library users with specific materials.

(m) Minutes of meetings of public bodies closed to the public as provided in the Open Meetings Act until the public body makes the minutes available to the public under Section 2.06 of the Open Meetings Act.

(n) Communications between a public body and an attorney or auditor representing the public body that would not be subject to discovery in litigation, and materials prepared or compiled by or for a public body in anticipation of a criminal, civil or administrative proceeding upon the request of an attorney advising the public body, and materials prepared or compiled with respect to internal audits of public bodies.

(o) Information received by a primary or secondary school, college or university under its procedures for the evaluation of faculty members by their academic peers.

(p) Administrative or technical information associated with automated data processing operations, including but not limited to software, operating protocols, computer program abstracts, file layouts, source listings, object modules, load modules, user guides, documentation pertaining to all logical and physical design of computerized systems, employee manuals, and any other information that, if disclosed, would jeopardize the security of the system or its data or the security of materials exempt under this Section.

(q) Documents or materials relating to collective negotiating matters between public bodies and their employees or representatives, except that any final contract or agreement shall be subject to inspection and copying.

(r) Drafts, notes, recommendations and memoranda pertaining to the financing and marketing transactions of the public body. The records of ownership, registration, transfer, and exchange of municipal debt obligations, and of persons to whom payment with respect to these obligations is made.

(s) The records, documents and information relating to real estate purchase negotiations until those negotiations have been completed or otherwise terminated. With regard to a parcel involved in a pending or actually and reasonably contemplated eminent domain proceeding under the Eminent Domain Act, records, documents and information relating to that parcel shall be exempt except as may be allowed under discovery rules adopted by the Illinois Supreme Court. The records, documents and information relating to a real estate sale shall be exempt until a sale is consummated.

(t) Any and all proprietary information and records related to the operation of an intergovernmental risk management association or self-insurance pool or jointly self-administered health and accident cooperative or pool.

(u) Information concerning a university's adjudication of student or employee grievance or disciplinary cases, to the extent that disclosure would reveal the identity of the student or employee and information concerning any public body's adjudication of student or employee grievances or disciplinary cases, except for the final outcome of the cases.

(v) Course materials or research materials used by faculty members.

(w) Information related solely to the internal personnel rules and practices of a public body.

(x) Information contained in or related to examination, operating, or condition reports prepared by, on behalf of, or for the use of a public body responsible for the regulation or supervision of financial institutions or insurance companies, unless disclosure is otherwise required by State law.

(y) Information the disclosure of which is restricted under Section 5-108 of the Public Utilities Act.

(z) Manuals or instruction to staff that relate to establishment or collection of liability for any State tax or that relate to investigations by a public body to determine violation of any criminal law.

(aa) Applications, related documents, and medical records received by the Experimental Organ Transplantation Procedures Board and any and all documents or other records prepared by the Experimental Organ Transplantation Procedures Board or its staff relating to applications it has received.

(bb) Insurance or self insurance (including any intergovernmental risk management association or self insurance pool) claims, loss or risk management information, records, data, advice or communications.

(cc) Information and records held by the Department of Public Health and its authorized representatives relating to known or suspected cases of sexually transmissible disease or any information the disclosure of which is restricted under the Illinois Sexually Transmissible Disease Control Act.

(dd) Information the disclosure of which is exempted under Section 30 of the Radon Industry Licensing Act.

(ee) Firm performance evaluations under Section 55 of the Architectural, Engineering, and Land Surveying Qualifications Based Selection Act.

(ff) Security portions of system safety program plans, investigation reports, surveys, schedules, lists, data, or information compiled, collected, or prepared by or for the Regional Transportation Authority under Section 2.11 of the Regional Transportation Authority Act or the St. Clair County Transit District under the Bi-State Transit Safety Act.

(gg) Information the disclosure of which is restricted and exempted under Section 50 of the Illinois Prepaid Tuition Act.

(hh) Information the disclosure of which is exempted under the State Officials and Employees Ethics Act.

(ii) Beginning July 1, 1999, information that would disclose or might lead to the disclosure of secret or confidential information, codes, algorithms, programs, or private keys intended to be used to create electronic or digital signatures under the Electronic Commerce Security Act.

(jj) Information contained in a local emergency energy plan submitted to a municipality in accordance with a local emergency energy plan ordinance that is adopted under Section 11-21.5-5 of the Illinois Municipal Code.

(kk) Information and data concerning the distribution of surcharge moneys collected and remitted by wireless carriers under the Wireless Emergency Telephone Safety Act.

(ll) Vulnerability assessments, security measures, and response policies or plans that are designed to identify, prevent, or respond to potential attacks upon a community's population or systems, facilities, or installations, the destruction or contamination of which would constitute a clear and present danger to the health or safety of the community, but only to the extent that disclosure could reasonably be expected to jeopardize the effectiveness of the measures or the safety of the personnel who implement them or the public. Information exempt under this item may include such things as details pertaining to the mobilization or deployment of personnel or equipment, to the operation of communication systems or protocols, or to tactical operations.

(mm) Maps and other records regarding the location or security of a utility's generation, transmission, distribution, storage, gathering, treatment, or switching facilities.

(nn) Law enforcement officer identification information or driver identification information compiled by a law enforcement agency or the Department of Transportation under Section 11-212 of the Illinois Vehicle Code.

(oo) Records and information provided to a residential health care facility resident sexual assault and death review team or the Executive Council under the Abuse Prevention Review Team Act.

(pp) Information provided to the predatory lending database created pursuant to Article 3 of the Residential Real Property Disclosure Act, except to the extent authorized under that Article.

(qq) Defense budgets and petitions for certification of compensation and expenses for court appointed trial counsel as provided under Sections 10 and 15 of the Capital Crimes Litigation Act. This subsection (qq) shall apply until the conclusion of the trial of the case, even if the prosecution chooses not to pursue the death penalty prior to trial or sentencing.

(rr) Information submitted to the Department of Public Health pursuant to Section 15 of the Safe Cosmetics Act concerning cosmetic ingredients considered to be a trade secret.

(2) This Section does not authorize withholding of information or limit the availability of records to the public, except as stated in this Section or otherwise provided in this Act.

(Source: P.A. 93-43, eff. 7-1-03; 93-209, eff. 7-18-03; 93-237, eff. 7-22-03; 93-325, eff. 7-23-03, 93-422, eff. 8-5-03; 93-577, eff. 8-21-03; 93-617, eff. 12-9-03; 94-280, eff. 1-1-06; 94-508, eff. 1-1-06; 94-664, eff. 1-1-06; 94-931, eff. 6-26-06; 94-953, eff. 6-27-06; 94-1055, eff. 1-1-07; revised 8-3-06.)

Section 99. Effective date. This Act takes effect upon becoming law.