BILL ANALYSIS                                                                                                                                                                                                    �






                             SENATE COMMITTEE ON HEALTH
                          Senator Ed Hernandez, O.D., Chair

          BILL NO:       SB 977
          AUTHOR:        Yee
          AMENDED:       June 4, 2012
          HEARING DATE:  June 13, 2012
          CONSULTANT:    Moreno

           SUBJECT  :  Sherman Food, Drug, and Cosmetic Law: nail polish.
           
          SUMMARY  :  Makes a manufacturer of nail polish that violates 
          provisions of the Sherman Food, Drug, and Cosmetic Law (Sherman 
          Law) related to misbranded cosmetics or any regulation adopted 
          pursuant to those provisions, if convicted, subject to a fine of 
          up to $15,000.

          Existing law:
          1.Prohibits misbranding of a cosmetic, as specified. 

          2.Requires the Department of Public Health (DPH), under the 
            Sherman Law, to regulate the manufacture, sale, labeling, and 
            advertising activities related to food, drugs, devices, and 
            cosmetics in conformity with the federal Food, Drug, and 
            Cosmetic Act. 

          3.Makes any person who violates any provision of the Sherman Law 
            or any regulation adopted pursuant to it, if convicted, 
            subject to imprisonment for up to one year in the county jail 
            or a fine of up to $1,000, or both.
          
          This bill:
          1.Makes a manufacturer of nail polish that violates provisions 
            of the Sherman Law related to misbranded cosmetics or any 
            regulation adopted pursuant to those provisions, if convicted, 
            subject to a fine of up to $15,000.

          2.Contains an urgency clause that will make this bill effective 
            upon enactment.

           FISCAL EFFECT  :  This bill is keyed non-fiscal.

           COMMENTS  :  
           1.Author's statement.  Consumers and nail salon workers deserve 
            to be informed of what is in the products they use. While we 
            have made great strides in ensuring safer working conditions 
                                                         Continued---



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            in nail salons, the presence of sometimes dangerous chemicals 
            still persists. There are no excuses for manufacturers to 
            mislabel or misrepresent the substances in their products. The 
            purpose of this bill is to influence the bad behavior of some 
            nail polish manufacturers by instituting a greater monetary 
            disincentive against mislabeling or misrepresenting the 
            ingredients in nail polish cosmetics. This bill attempts to 
            address a health and public safety risk to consumers and, 
            especially, the nail salon workers who are exposed to nail 
            polish on a daily basis. 
            
          2.Background.  According to the Department of Toxic Substance 
            Control (DTSC), nail products are known to contain toxic 
            chemicals, such as dibutyl phthalate (DBP), toluene, and 
            formaldehyde, that are health and safety concerns for about 
            121,000 nail salon workers in California. DBP and toluene are 
            known to the state of California as developmental toxins. 
            Formaldehyde is a known carcinogen. These three chemicals are 
            commonly called the "toxic-trio" and are a part of an ongoing 
            debate over nail product safety and potential health risks for 
            nail salon workers.

          3.DTSC report.  In May of 2011, DTSC conducted a limited-scale 
            sampling of nail products offered for sale in the San 
            Francisco Bay Area. A small number of nail product 
            manufacturers claimed to have removed some or all toxic-trio 
            chemicals from their goods. DTSC's objective in sampling the 
            products was to verify the removal of the toxic-trio in nail 
            polish, to determine baseline levels of certain chemicals, and 
            to examine trends of ingredient substitutions. Twenty-five 
            products, representing six product categories, were randomly 
            collected from six distributors who supply products to nail 
            salons. Of the twenty-five products collected, manufacturers 
            claimed that twelve were free of at least one toxic-trio 
            chemical and seven were free of all three toxic-trio 
            chemicals. Manufacturers of thirteen products made no claims 
            about chemical content (DTSC refers to these as "traditional 
            products"). 

            Toluene was found more frequently and in higher concentrations 
            in products that were claimed to be free of one or more of the 
            toxic-trio chemicals than in traditional products. Ten of the 
            twelve products with "toluene-free" claims actually contained 
            toluene. Claims by manufacturers that products were free of 
            all three chemicals could not be substantiated in five out of 
            seven instances.  DTSC also detected chemicals whose purpose, 




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          3


          

            property, human toxicity, and environmental fate are unknown. 
            Based on the findings, DTSC recommended that manufacturers 
            disclose nail product formulations. Additionally, DTSC urged 
            increased collaboration and coordination among interested 
            stakeholders, along with expanded outreach, education, and 
            training of nail salon owners and workers.

          4.Double referral. This bill is double referred. Should it pass 
            out of this committee, it will be referred to the Senate 
            Committee on Public Safety.

          5.Prior legislation.  AB 237 (Galgiani) of 2011 and AB 595 
            (Dymally) of 2007 would have required cosmetic product 
            manufacturers that do not comply with the U.S. Food and Drug 
            Administration (FDA) Voluntary Cosmetic Reporting Program 
            (VCRP) to provide to DPH the same kind of information 
            disclosed through the VCRP. AB 237 was held on the Assembly 
            Appropriations Committee suspense file, and AB 595 was held on 
            the Senate Appropriations Committee suspense file.

            SB 1712 (Migden) of 2008 would have required a manufacturer of 
            lipstick sold in this state to provide evidence to DPH that 
            the lipstick contains no more than an unavoidable trace of 
            lead. SB 1712 died in the Assembly Health Committee.

            SB 484 (Migden), Chapter 729, Statutes of 2005, establishes 
            the California Safe Cosmetics Act of 2005, which requires 
            cosmetic manufacturers to disclose to DPH a list of their 
            products' chemical ingredients that cause cancer or 
            reproductive harm.

            AB 908 (Chu) of 2005 would have prohibited a person or entity 
            from manufacturing, selling, or distributing in commerce any 
            cosmetic that contains any of two specified phthalates, and 
            would have defined a cosmetic as misbranded if sold by an 
            internet website where the list of ingredients in the cosmetic 
            is not easily viewable before the purchase. AB 908 failed 
            passage in the Assembly Health Committee.
            AB 2025 (Chu) of 2004 would have required the manufacturer of 
            any cosmetic or personal care product sold in California to 
            submit to the California Office of Environmental Health Hazard 
            Assessment (OEHHA) a list of ingredients contained in the 
            product, including the name of each ingredient for purposes of 
            fragrance or flavoring and the name of each ingredient 
            identified by the phrase "and other ingredients." AB 2025 




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            would have banned a cosmetic or personal care product that 
            contains a chemical known to cause cancer or reproductive 
            toxicity unless OEHHA issued a safe use determination on that 
            product. AB 2025 was not heard in the Assembly Health 
            Committee at the request of the author.

            AB 2012 (Chu) of 2004 would have required, by January 1, 2006, 
            the manufacturer of any cosmetic or personal care product 
            subject to regulation by the FDA and manufactured, processed, 
            or distributed in commerce in the state to notify OEHHA of any 
            ingredient in its product that is a chemical identified as 
            causing cancer or reproductive toxicity, as specified.  AB 
            2012 failed passage in the Assembly Health Committee.
          
          6.Policy comment.  This bill raises the penalty for misbranding 
            of one type of product to $15,000 while the penalty for 
            misbranding other products will remain $1,000. The bill's 
            urgency clause states that the bill is needed in order to 
            protect the health and safety of consumers and salon workers 
            from the harmful effects of some of the ingredients of nail 
            polish. There may be other cosmetic products that contain 
            harmful chemicals and pose risks to the health of consumers 
            and workers. It is unclear what sets the use of nail polish 
            apart from the use of other cosmetic products. If a $1,000 
            fine is an insufficient deterrent to prevent the misbranding 
            of nail polish, perhaps the author should consider raising the 
            penalty for misbranding cosmetic products across the board. 

           SUPPORT AND OPPOSITION  :
          Support:  Personal Care Products Council

          Oppose:   None received.

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