BILL ANALYSIS                                                                                                                                                                                                    



                                                                  SB 484
                                                                  Page  1

          Date of Hearing:   June 28, 2005

                            ASSEMBLY COMMITTEE ON HEALTH
                                  Wilma Chan, Chair
                     SB 484 (Migden) - As Amended:  June 15, 2005

           SENATE VOTE  :   23-15
           
          SUBJECT  :   Cosmetics: chronic health effects.

           SUMMARY  :   Establishes the California Safe Cosmetics Act of  
          2005.  Specifically,  this bill  :   

          1)Makes a number of findings and declarations, including that  
            testing has determined that some cosmetic products contain  
            substances known or suspected to cause cancer and reproductive  
            toxicity, there is a lack of ingredient labeling on certain  
            products, there is a heavy use of cosmetics by women of  
            childbearing age, and there is an availability to alternative  
            substances for use in cosmetics. 

          2)Defines a "chemical identified as causing cancer or  
            reproductive toxicity" as a chemical identified pursuant to  
            Proposition 65 (Prop 65) or identified by an authoritative  
            body, as defined, as a substance:

             a)   Listed as known or reasonably anticipated to be a human  
               carcinogen in a National Toxicology Report on carcinogens;

             b)   Given an overall carcinogenicity evaluation of Group 1,  
               Group 2A, or Group 2B by the International Agency for  
               Research on Cancer (IARC);

             c)   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 (EPA); and, 

             d)   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.

          3)Requires the manufacturer of any cosmetic product subject to  
            regulation by the Food and Drug Administration (FDA) that is  








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            sold in this state, commencing January 1, 2007, to, on a  
            schedule determined by the Division of Environmental and  
            Occupational Disease Control (DEODC) of the Department of  
            Health Services (DHS), provide DEODC with a complete and  
            accurate list of its cosmetic products, as specified, that are  
            sold in the state as of the date of submission and identify by  
            product any ingredient, as defined, that is a chemical  
            identified as causing cancer or reproductive toxicity,  
            including any chemical that is:

             a)   Contained in the product for purposes of fragrance or  
               flavoring; or, 

             b)   Identified by the phrase "and other ingredients" and  
               determined to be a trade secret, as specified.  Requires  
               any ingredient identified pursuant to this bill to be  
               considered to be a trade secret and be treated by the  
               office in a manner consistent with current federal law.   
               Prohibits any ingredients considered to be a trade secret  
               from being subject to the California Public Records Act for  
               the purposes of this bill.

          4)Requires the manufacturer, if an ingredient identified  
            pursuant to this bill is removed from a product and removed  
            from the list of chemicals known to cause cancer or  
            reproductive toxicity under Prop 65 or is no longer a chemical  
            identified as causing cancer or reproductive toxicity by an  
            authoritative body, to submit that information to the DEODC.   
            Requires DEODC, upon receipt of new information and after  
            verifying its accuracy, to revise the manufacturer's  
            information on record.  Prohibits the manufacturer from being  
            under obligation to submit subsequent information on the  
            presence of the ingredient in the product unless subsequent  
            changes require submittal of the information.

          5)Exempts any cosmetics manufacturer with annual aggregate sales  
            of cosmetic products, both within and outside of California,  
            of less than $1 million, based on the manufacturer's most  
            recent tax year filing from the provisions contained in #3)  
            and #4) above. 

          6)Permits DEODC, in order to determine potential health effects  
            of exposure to ingredients in cosmetics sold in the state, to  
            conduct an investigation of one or more cosmetic products that  
            contain chemicals identified as causing cancer or reproductive  








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            toxicity or other ingredients of concern to DEODC.  Permits  
            such an investigation to include, but not be limited to, 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.  

          7)Permits the manufacturer of any product subject to the  
            investigation to submit relevant health effects data and  
            studies to DEODC.  Permits DEODC, in order to further the  
            purposes of an investigation, to require manufacturers to  
            submit relevant health effects data and studies available to  
            the manufacturer and other available information as requested,  
            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.

          8)Requires DEODC to establish reasonable deadlines for the  
            submittal of information. Specifies that failure by a  
            manufacturer to submit the information in compliance with the  
            requirements of DEODC constitutes a violation of this bill.

          9)Requires DEODC, if it determines pursuant to an investigation  
            that an ingredient in a cosmetic product is potentially toxic  
            at the concentrations present in the product or under the  
            conditions used, to immediately refer the results of its  
            investigation to the Division of Occupational Safety and  
            Health (DOSH) in the Department of Industrial Relations (DIR)  
            and the Office of Environmental Health Hazard Assessment  
            (OEHHA).

          10)Requires DOSH, within 180 days after it receives the results  
            of an investigation, to develop and present one or more  
            proposed occupational health standards to the DIR Occupational  
            Safety and Health Standards Board (OSHSB), unless DOSH  
            affirmatively determines, in a written finding within 90 days,  
            that a standard is not necessary to protect the health of an  
            employee who has regular exposure to the hazard for the period  
            of his or her working life.  Requires the written finding to  
            identify the reasons for the determination and the factual  
            basis for the finding.









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          11)Requires DEODC, as early as feasible within existing  
            resources, to determine whether the products identified as in  
            violation of the Cosmetic Ingredient Review's (CIR) safe use  
            recommendations have been adequately substantiated for safety  
            pursuant to federal law.  Requires DEODC, for any product  
            adequately substantiated for safety, to 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.

          12)Requires DEODC, if it finds that a product 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, to refer its findings to  
            the Attorney General and the FDA for possible enforcement  
            action pursuant to this bill and the federal Food, Drug and  
            Cosmetic Act.

           EXISTING LAW  :

          1)Regulates the packaging, labeling, and advertising of food,  
            drugs, and cosmetics under the Sherman Food, Drug, and  
            Cosmetic Law.  Prohibits a person from manufacturing, selling,  
            delivering, holding, offering for sale, or receiving in  
            commerce any cosmetic that is adulterated, and prohibits a  
            person from adulterating any cosmetic.  Prohibits a person  
            from manufacturing or selling any cosmetic that is misbranded,  
            as prescribed.

          2)Under Prop 65, requires the Governor to revise and publish a  
            list of chemicals that have been scientifically proven to  
            cause cancer or reproductive toxicity each year.  Prohibits  
            any person in the course of doing business in California from  
            knowingly exposing any individual to a chemical known to the  
            state to cause cancer or reproductive toxicity without first  
            giving clear and reasonable warning.

          3)Pursuant to federal law, requires the FDA to request the  
            manufacturer, packer, or distributor of a cosmetic product to  
            submit, among other information, a list of ingredients in each  
            of its products, and to provide ingredient information to a  
            licensed physician who requests assistance in determining  
            whether an ingredient in the product is the cause of a problem  
            for which the patient is being treated.  Requires any change  
            in information to be filed within 60 days after the product  
            enters into commercial distribution.  Makes specific labeling  








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            requirements, including mandating that all ingredients be  
            listed on the label.  Permits manufacturers to submit a  
            request of confidentiality of identity of an ingredient by  
            presenting factual and legal grounds for that request.   
            Requires a product to bear a warning statement, prominently  
            and conspicuously displayed on the label, whenever necessary  
            or appropriate to prevent a health hazard that may be  
            associated with the product.  Requires each ingredient used in  
            a cosmetic product to be adequately substantiated for safety  
            prior to marketing and requires any product whose safety is  
            not substantiated to contain a conspicuous statement so  
            stating.  Permits the FDA to collect samples for examination  
            of products and to take action through the U. S. Department of  
            Justice to remove adulterated and misbranded cosmetics from  
            the market.

           FISCAL EFFECT  :   According to the Senate Appropriations  
          Committee analysis, $100,000 general fund (GF) for the receipt  
          of disclosures by DHS in fiscal year (FY) 2005-06; GF costs of  
          $863,000 in FY 2006-07 and $1.2 million GF in FY 2007-08 for the  
          receipt of disclosures, testing, and environmental  
          investigation.  The testing and investigation costs are  
          discretionary on the part of DHS, and would be subject to the  
          availability of funding in future budgets.  Costs to DIR are  
          unknown and depend upon the number of submittals by DHS  
          following an investigation. 

           COMMENTS  :   

           1)PURPOSE OF THIS BILL  According to the author, chemicals that  
            cause cancer and birth defects should not be in products that  
            are used regularly by women of child-bearing age, especially  
            when there are safe alternatives.  Neither DHS nor the FDA has  
            any statutory authority to analyze cosmetic products for their  
            possible long-term health impacts, such as cancer and birth  
            defects.  The law also shields cosmetic manufacturers from  
            informing the public about toxic chemicals used in their  
            products for fragrance and flavoring.  Recent studies suggest  
            these ingredients can include chemicals that cause cancer and  
            birth defect.  This bill requires cosmetic manufacturers to  
            tell DHS what chemicals in their products cause cancer or  
            reproductive toxicity and gives the state the authority to  
            protect the public from dangerous exposures to those  
            chemicals.









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           2)PROPOSITION 65  .  The Safe Drinking Water and Toxic Enforcement  
            Act of 1986 (commonly known as Prop 65), provides two primary  
            mechanisms for administratively listing chemicals that are  
            known to the state to cause cancer or reproductive toxicity.   
            A chemical may be listed under Prop 65 when a body considered  
            to be authoritative by the state's qualified experts has  
            formally identified the chemical as causing cancer or  
            reproductive toxicity.  The entities identified as  
            "authoritative bodies" for purposes of Prop 65 include the  
            EPA, the International Agency for Research on Cancer, the FDA,  
            the National Institute for Occupational Safety and Health, and  
            the National Toxicology Program (NTP).  As the lead agency for  
            the implementation of Prop 65, OEHHA lists chemicals as known  
            to the state to cause reproductive toxicity.  



           3)COSMETIC LABELING  .  According to the FDA, all cosmetics,  
            whether they are sold on a retail basis to consumers or  
            marketed for salon or workplace use, are subject to the Food,  
            Drug and Cosmetics Act.  This law and subsequent regulations  
            require the cosmetic label to state the name and place of  
            business of the manufacturer, packer or distributor; an  
            accurate statement of the quantity of contents; and any  
            appropriate directions for safe use and/or warning statements.  
             This information must comply with additional regulatory  
            requirements and be prominent and appear in the proper  
            location on the label.  Regulations enacted under the Fair  
            Packaging and Labeling Act require ingredients to be listed on  
            the labels of cosmetics sold on a retail basis to consumers.  
            Ingredients are listed in descending order of predominance.   
            The FDA states that consumers can use the ingredient  
            declaration to identify ingredients they wish to avoid.   
            Cosmetic products and ingredients are not subject to FDA  
            testing or approval, with the exception of color additives.   
            According to the FDA, cosmetic manufacturers are responsible  
            for substantiating the safety of their products and  
            ingredients before marketing.  The FDA is not authorized to  
            require recalls of "hazardous" cosmetics, but does monitor  
            companies that conduct product recall and may request a recall  
            if the manufacturer is not willing to remove dangerous  
            products from the market. 










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           4)COSMETIC INGREDIENT REVIEW  .  According to the CIR website, it  
            was established in 1976 by the Cosmetic, Toiletry & Fragrance  
            Association (CTFA) with support of the FDA and the Consumer  
            Federation of America (CFA).  Although funded by CTFA, CIR and  
            the review process are independent from CTFA and the cosmetics  
            industry.  According to the CIR, it reviews and assesses the  
            safety of ingredients used in cosmetics in an open, unbiased,  
            and expert manner, and publishes the results in the open,  
            peer-reviewed scientific literature.  The seven CIR Expert  
            Panel voting members include physicians and scientists who  
            have been publicly nominated by consumer, scientific and  
            medical groups, government agencies and industry.  Three  
            liaison members serve as non-voting members representing the  
            FDA, CFA, and CTFA.  Working on the "high priority"  
            ingredients, the CIR conducts literature searches, compile  
            data, and prepare draft reports.  If the scientific literature  
            contains insufficient information, CIR requests the industry  
            or other interested parties to undertake specific studies or  
            to provide previously unpublished data.  After completion of a  
            development process that includes multiple opportunities for  
            public comment and open, public discussion of the report, a  
            final report is issued.   These final reports are available  
            from CIR and published in the International Journal of  
            Toxicology.



            A May 1992 article in the FDA's consumer magazine said the CIR  
            was the "most well-known of industry-sponsored self-regulation  
            . . . sponsored by the CTFA."  The CIR is accomplished by a  
            panel of scientific and medical experts who evaluate cosmetic  
            ingredients for safety and publish detailed reviews of  
            available safety data.  The article went on to say that "A  
            finding of safety by the CIR provides a degree of confidence  
            that the ingredient can safely be used in cosmetics,"  and  
            that in the absence of CIR, there would be no systematic  
            examination of the safety of individual cosmetic ingredients.


           5)EUROPEAN UNION BAN  .  According to the sponsors of this bill,  
            National Environmental Trust, Breast Cancer Action, and Breast  
            Cancer Fund, in January 2003, the European Parliament  
            prohibited the use in cosmetics of certain chemicals that  
            cause cancer, reproductive harm, or mutagenicity.  The ban,  








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            which took effect in September of 2004, is absolute for  
            chemicals that fall in categories 1 and 2 of these substances.  
             For category 3, it is conditional, meaning a manufacturer may  
            use the chemicals only if the proposed use is determined to be  
            safe.  The categories denote the level of certainty that the  
            chemical harms human health.  Category 1 substances are those  
            that are known to cause the specified health problems in  
            humans.  Category 2 substances are known to cause the effects  
            in animals and the scientific literature is strong enough that  
            the European Union has determined to treat the chemicals as  
            though they cause the effects in humans.  Category 3  
            substances have also shown health effects in animals, but the  
            scientific literature is less robust than for category 2.   
            These terms correspond to the terms "known," "probable," and  
            "possible" used by the EPA to describe health effects of  
            chemicals. 

           6)RELATED LEGISLATION .  AB 908 (Chu) prohibits a person or  
            entity, on or after January 1, 2007, from manufacturing,  
            selling, or distributing in commerce any cosmetic that  
            contains dibutyl phthalate (DBP) or di-(2-ethylhexyl)  
            phthalate (DEHP) and provides that any cosmetic is misbranded  
            if it is sold by an Internet Web site where the list of  
            ingredients in the cosmetic is not easily and readily  
            available to be viewed by the prospective purchaser before the  
            purchase is completed.  AB 908 failed passage in the Assembly  
            Committee on Health when it was heard on April 19, 2005 by a  
            vote of 5-5.

           7)PREVIOUS LEGISLATION  .  Last year, AB 2025 (Chu) would have  
            required the manufacturer of any cosmetic or personal care  
            product sold in California to submit to 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 would also have required the  
            manufacturer to identify any ingredient that is a chemical  
            identified as causing cancer or reproductive toxicity or to  
            declare in writing to OEHHA that its products do not contain  
            any chemical identified as causing cancer or reproductive  
            toxicity.  Finally, the bill would have prohibited any person  
            from manufacturing, processing, or distributing in a cosmetic  
            or personal care product that contains a chemical identified  
            as causing cancer or reproductive toxicity.  AB 2025 was set  
            to be heard in the Assembly Committee on Health, but the  








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            hearing of this bill was cancelled at the request of the  
            author.  

          Also last year, AB 2012 (Chu) was amended in the Senate to  
            require, 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.  This bill failed passage in the  
            Assembly Committee on Health by a vote of 4-5.

           8)SUPPORT  .  The National Environmental Trust (NET) states that  
            men use multiple cosmetic and personal care products and women  
            use an estimated 25 such products a day.  NET states that a  
            class of chemicals called phthalates, known to cause cancer  
            and reproductive toxicity are used in cosmetic products and  
            that a national laboratory found phthalates in 52 of 72  
            products tested even though the chemical was not listed on the  
            product label.  NET writes that in 1978 the U.S. Governmental  
            Accounting Office told Congress that certain cosmetics  
            marketed in the United States contain ingredients that may  
            cause cancer, cause birth defects, or have other health  
            consequences.  Numerous supporters claim that those most at  
            risk to exposure to carcinogens and reproductive toxins are  
            nail and beauty salon workers and that these women are  
            generally of child-bearing age.  Breast Cancer Action states  
            that not only do women of child-bearing age frequently use  
            personal care products, they also transfer many of the  
            chemicals they contain across the placental cord to the  
            developing fetus.  Asian Americans for Civil Rights and  
            Equity, the California Nurses Association, Asian Health  
            Services, the Asian Pacific Environmental Network, and  
            California Women Lawyers claim the FDA does not review  
            cosmetic ingredients for their health and safety before they  
            come to market nor have the authority to recall hazardous  
            products and relies instead on the industry's self-policing  
            committee, the CIR, for information on product safety.  Garden  
            of Eve writes they take responsibility for the safety of their  
            products and believe it is necessary in their industry's best  
            interest to provide U.S. consumers the same protection  
            provided to European consumers.  The California League of  
            Conservation Voters state that this bill is a responsible  
            proposal that recognizes fiscal constraints and reduces  
            mandated costs to a minimum.  








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           9)OPPOSE  .  Raffaello Research Laboratories, Inc states that this  
            bill would require all manufacturers of personal care products  
                                                  and cosmetics who sell products in California to report every  
            ingredient, including trace amounts of any chemical, in their  
            products to DHS.  Raffaello argues that Prop 65 allows trace  
            levels of chemicals known to cause cancer or reproductive  
            toxicity and that trace levels of these chemicals are found in  
            water and food.  A number of companies, including GAR  
            Laboratories, Alberto Culver Company, TCR Industries,  
            Universal Packaging Systems, Inc., Kimberly-Clark, Creative  
            Nail Design, American International Industries, and SMAP  
            Manufacturing, Inc. write that every cosmetic manufacturer who  
            sells products in California is already subject to a long list  
            of federal and state laws and rules governing everything from  
            product formulation to air quality.   Estee Lauder writes that  
            this bill references chemical lists prepared by three  
            different institutions without providing exceptions for  
            unintended or unavoidable trace amounts of ingredients, an  
            exception recognized under federal regulations, EU law, and  
            other existing California law.    Numerous individuals write  
            that that this bill is not based on sound scientific evidence  
            or standard safety practice.  The California Chamber of  
            Commerce contends that this bill places an unnecessary burden  
            on the hundreds of cosmetic and personal care product  
            manufacturers in this state and provides no benefit to public  
            health and will only serve to charge the state government and  
            manufacturers with new and significant costs.  The Grocery  
            Manufacturers of America states that this bill requires the  
            reporting of chemicals even though they are present in forms  
            or at levels that pose no health risk.
           
           10)   SUGGESTED AMENDMENTS  .  

             a)   On page 6, line 24, "division" should replace the word  
               "office." 

             b)   In order to conform with other language related to DEODC  
               duties, the author may wish to delete the word "shall" on  
               page 9, line 11 and insert "may."

           REGISTERED SUPPORT / OPPOSITION  :

           Support 
           








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          National Environmental Trust (sponsor)
          Breast Cancer Fund (co-sponsor)
          Breast Cancer Action (co-sponsor)
          AMURIE toxic free products
          Asian Americans for Civil Rights and Equality (AACRE)
          Asian Communities for Reproductive Justice (ACRJ)
          Asian Health Services
          Asian Immigrant Women Advocates
          Asian Pacific Environmental Network (APEN)
          Association of Asian Pacific Community Health Organizations  
          (AAPCHO)
          California Black Women's Health Project
          California Church IMPACT/California Council of Churches
          California Commission on the Status of Women
          California Interfaith Partnership for Children's Health and the  
          Environment
          California League of Conservation Voters
          California Nurses Association
          California Women Lawyers
          Center for Environmental Health
          Center for Ethics and Toxics (CETOS)
          Chinese for Affirmative Action/Center for Asian American  
          Advocacy (CAA)
          Commonweal Biomonitoring Center
          Dropwise Essentials
          East Bay Asian Consortium
          Ecology Action of Santa Cruz
          Environment California
          Environmental Justice Coalition for Water
          Filipino American Coalition for Environmental Solutions (FACES)
          Filipinos for Affirmative Action (FAA)
          Friends Committee on Legislation
          Friends of the Earth
          Garden of Eve
          J.P. Durga, LLC
          Learning Disabilities Association of California
          Marie Veronique Skin Therapy
          Mariun Cancer Project
          National Brain Tumor Foundation
          National Resources Defense Council
          Orange County Interfaith Coalition for the Environment
          Physicians for Social Responsibility San Francisco-Bay Area  
          Chapter
          Presbyterians for Restoring Creation
          Sierra Club California








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          Silicon Valley Toxics Coalition
          The Women's Foundation of California
          United Food and Commercial Workers
          VietUnity
          153 individuals
           
            Opposition 
           
          2-2-0 Laboratories
          Alberto Culver
          American Chemistry Council
          American Health and Beauty Aids Institute
          American International Industries
          Anna Nails
          BioOrganic Concepts
          California Botana International, Inc.
          California Chamber of Commerce
          California Grocers Association
          California Retailers Association
          Chicago Aerosol
          Clinical Industry Council
          Color Techniques 
          Cosmetic, Toiletry, and Fragrance Association
          Cosmoceutical Research Center
          Creative Nail Design
          Derma e
          DERMdoctor
          Dermix
          Dial Corporation
          Doctors' Dermatologic Corporation
          Elizabeth Arden
          Environ Skin Care
          Estee Lauder Companies, Inc.
          Flavor and Extract Manufacturers Association
          Floratech
          Formulation Research Laboratories, LLC
          Fragrance Materials Association
          GAR Labs
          Gillette Company
          Grocery Manufacturers of America
          Herbalife
          Innovative Body Science
          International Cosmetics
          Johnson & Johnson
          Kao Brands Company








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          Kimberly Clark Corporation
          Laboratoire Dr. Renaud
          Laclede, Inc.
          Levlad, Inc.
          Maleface Skin Care
          MDPar International Corporation
          Murad
          Nailtiques
          Neostrata Company
          Nitrilife
          NuSkin
          Nyakio Bath and Body
          OPI Products, Inc.
          Pacific World
          Procter & Gamble
          Raffaello Research Laboratories
          Randall International, LLC
          Sacramento Asian Pacific Chamber of Commerce
          Sacramento Hispanic Chamber of Commerce
          Schroeder & Tremayne, Inc.
          Schwarzkopf Professional
          SEPPIC
          Shaklee Corporation
          SMAP Manufacturing
          Spatz Laboratories
          TCR Industries
          Unilever
          Universal Packaging Systems
          USANA
          Victoria Consulting
          Wella Corporation
          156 individuals


           Analysis Prepared by  :    Melanie Moreno / HEALTH / (916)  
          319-2097