If at first you don't succeed . . . .

Congress returns to Washington  from the August recess this week and among the bills that may come up for consideration between now and the end of the 1st session of the 112th Congress is H.R. 2359, the "Safe Cosmetics Act of 2011", introduced by Rep. Janice Schakowsky (D-IL-9th) on June 24, 2011 and subsequently referred to the House Committees on Energy and Commerce and Education and the Workforce.

As that noted philosopher, wordsmith, catcher and manager of the New York Yankees and the New York MetsLawrence "Yogi" Berra once expressed, "It's deja vu all over again."

H.R. 2359 is an only slightly changed version of H.R. 5786, the "Safe Cosmetics Act of 2010", introduced by Rep. Schakowsky on July 20, 2010 and referred to the same House Committees (the House Committee on Education and the Workforce was then known as the House Committee on Education and Labor) and discussed here on July 26, 2010.

The language affecting nanoparticles in cosmetics, section 613 in H.R. 2359, is the same as it was in section 618 of the previous bill:

SEC. 613. INGREDIENTS LABELS ON COSMETICS

 

    `(d) Labeling of Nanomaterials in Cosmetics- The Secretary may require that--

 

      `(1) minerals and other particulate ingredients be labeled as `nano-scale' on a cosmetic ingredient label or list if not less than 1 percent of the ingredient particles in the cosmetic are 100 nanometers or smaller in not less than 1 dimension; and

 

      `(2) other ingredients in a cosmetic be designated with scale-specific information on a cosmetic ingredient label or list if such ingredients possess scale-specific hazard properties.

Similarly, the language of section 614 in H.R. 5786 is now part of section 615 in H.R. 2359:

SEC. 615. COSMETIC AND INGREDIENT SAFETY INFORMATION.

      `(2) CONSIDERATION OF NANOMATERIALS- The Secretary shall--

 

        `(A) monitor developments in the scientific understanding from any adverse health effects related to the use of nanotechnology in the formulation of cosmetic (including progress in the standardization of testing methods and specific size definitions for nanomaterials); and

 

        `(B) consider scale specific hazard properties of ingredients when reviewing and evaluating the safety of cosmetics and ingredients under paragraph (1).

       

No hearings on H.R. 5786 were ever held, nor was it reported out of committee. No hearings are currently scheduled for H.R. 2359.

H.R. 5786 "Safe Cosmetics Act of 2010" Introduced

Rep. Janice Schakowsky, with Reps. Ed Markey and Tammy Baldwin among the co-sponsors, introduced H.R. 5786, the "Safe Cosmetics Act of 2010" on 07/20/2010. The act would amend Chapter VI of the Federal Food, Drug & Cosmetic Act by adding new language regarding the marketing, labelling, testing and regulation of cosmetic manufacturers, packagers and distributors.

Two sections of the bill would affect the use of nanotechnology and nanoparticles in cosmetics:

`SEC. 614. COSMETIC AND INGREDIENT TESTING AND SAFETY.

    `(d) Nanomaterials in Cosmetics- The Secretary shall--

 

      `(1) monitor developments in the scientific understanding of any adverse health effects related to the use of nanotechnology in the formulation of cosmetics; and

 

      `(2) consider scale specific hazard properties of ingredients when conducting or reviewing safety substantiation of cosmetic ingredients.

 

SEC. 618. COSMETIC AND INGREDIENT STATEMENTS.

    `(e) Labeling of Nanomaterials in Cosmetics- The Secretary may require that--

 

      `(1) minerals and other particulate ingredients be labeled as `nano-scale' on a cosmetic ingredient label or list if not less than 1 dimension is 100 nanometers or smaller for not less than 1 percent of the ingredient particles in the cosmetic; and

 

      `(2) other ingredients in a cosmetic be designated with scale-specific information on a cosmetic ingredient label or list if such ingredients possess scale-specific hazard properties.

Other sections of the bill would require:

Domestic manufacturers, packagers and distributors and foreign manufacturers, packagers and distributors who export to the United States to register annually with the Secretary of Health and Human Services (HHS); registration would include information about locations of facilities and trade names, numbers of employees at each location, gross receipts of sales and names and addresses of materials suppliers

Labels on each package of cosmetics would need to name each ingredient in descending order of dominance in the cosmetic. Internet vendors would need to post this information on their websites.

Within one year of the bill's enactment into law

manufacturers and distributors of cosmetics and ingredients shall submit to the Secretary (in an electronic format that the Secretary shall determine) all reasonably available information in the possession or control of the manufacturer or distributor that has not previously been submitted to the Secretary regarding the physical, chemical, and toxicological properties of single or multiple chemicals listed on the cosmetic labels under section 613, including--

 

          `(i) functions and uses;

 

          `(ii) exposure and fate information;

 

          `(iii) tests of finished cosmetics; and

 

          `(iv) any other information used to substantiate the safety of such cosmetics or ingredients.

         

The Secretary would, not later than 1 year following enactment, create a publicly accessible database of non-confidential information submitted by manufacturers and distributors.

Within two years of enactment, the Secretary would publish and periodically update lists of prohibited, restricted and safe ingredients

Manufacturers, packagers and distributors would be required to submit reports "containing information received concerning any serious adverse event associated with the use of the cosmetic". These reports would be available to the public via the HHS website.

Other provisions would require to the Secretary of Labor to

promulgate an occupational safety and health standard under section 6 of the Occupational Safety and Health Act of 1970 (29 U.S.C. 655) that requires the following:

 

      (1) MANUFACTURERS AND IMPORTERS-

 

        (A) IN GENERAL- Each manufacturer or importer selling any cosmetic for professional use shall--

 

          (i) obtain or develop an expanded material safety data sheet described in subsection (b) for each such cosmetic or personal care product that--

 

            (I) the manufacturer or importer produces or imports; and

 

            (II) includes a hazardous chemical, or product ingredient associated with any chemical hazard, that has been indicated by authoritative bodies or scientific studies to be linked to health hazards including mutation, reproductive or developmental toxicity, neurotoxicity, endocrine disruption, asthma, or other immunological toxicity; and

 

          (ii) make the expanded material safety data sheet available to distributors and employers, including salon owners, in English and, upon request, in other languages, including Spanish and Vietnamese.

 

        (B) PROFESSIONAL USE DEFINED- In this paragraph, the term `professional use' has the meaning given such term in section 611 of the Federal Food, Drug, and Cosmetic Act.

 

      (2) DISTRIBUTORS- Each distributor of a cosmetic or personal care product for professional use shall distribute and provide expanded material safety data sheets described in subsection (b) in the same manner as a distributor of a chemical hazard is required to distribute and provide material safety data sheets under section 1910.1200(g) of title 29, Code of Federal Regulations, or any successor regulations.

 

      (3) EMPLOYERS- Each employer, including any operator of a salon, shall--

 

        (A) have an expanded material safety data sheet in the workplace for each cosmetic or personal care product for professional use that is used in the course of the employer's business;

 

        (B) make such expanded material safety data sheet available to all employees of the employer who are exposed or use the product to the same extent and in the same manner as material safety data sheets are required to be made available under section 1910.1200(g) of title 29, Code of Federal Regulations, or any successor regulations; and

 

        (C) upon request, provide employees with translations of such expanded material safety data sheet in other languages, including Spanish and Vietnamese.

 

    (b) Contents of Expanded Material Safety Data Sheet- An expanded material safety data sheet for a cosmetic or personal care product for professional use described in this section shall--

 

      (1) contain the information required in a material safety data sheet under section 1910.1200(g) of title 29, Code of Federal Regulations, or any successor regulations, for each hazardous chemical, or product ingredient associated with any chemical hazard, described in subsection (a)(1)(A)(i)(II); and

 

      (2) include the following statement: `This expanded material safety data sheet is also available in multiple languages by contacting the manufacturer, using the contact information provided on this sheet.'.

     

H.R. 5786 has been referred to the House Committee on Energy and Commerce and the House Committee on Education and Labor.