Study of Exposure to Chemicals in Consumer Products
Condition: Product Use
Study type: Observational

Summary: 
      Background:

      - In a lifetime, a person may encounter tens of thousands of chemicals used as ingredients in
      the products they buy. It s not easy to measure them because the companies that sell the
      products don t have to tell the exact chemical ingredients. Researchers want to compare how
      existing methods (e.g., surveys and models) measure exposure to chemicals in personal care
      and household products.

      Objective:

      - To test and improve the ways that studies gather data about contact with chemicals found in
      consumer products.

      Eligibility:

      - Healthy women volunteers ages 35 74 who use at least 15 consumer products a day.

      Design:

        -  Participants will be screened with medical history, pregnancy test, smoking test, and
           blood sample. They will answer questions about their homes and products they use.

        -  Participation will last about 30 hours over 12 days.

        -  Researchers will:

        -  Place air samplers inside and outside participants homes for 10 days. One sampler will
           need to be plugged into an electrical outlet. It will make a low, continuous sound while
           in operation.

        -  Collect house dust samples and record all consumer products in the house.

        -  Visit the house daily to collect samples.

        -  Participants will:

        -  Give a blood sample at a clinic twice.

        -  Collect all urine voids for 10 days. They will label it and put it in a special cooler.

        -  Wear 4 small devices that measure air pollution, chemicals, location, and activity.

        -  Record what they eat and what consumer products they use. They will write these in a
           diary and <TAB>photograph them on an iPhone provided to them.

        -  On day 2 of the study, they will collect a duplicate sample of what they eat.

        -  Take iPhone videos of their use of certain products.

        -  Answer questions about chemical ingredients in their personal care products.
    

Detailed description: 
      Research to advance the characterization of environmental and chemical exposures through
      improved exposure assessments, at both the individual and population levels, is a research
      priority identified in the Strategic Research Action Plan for the U.S. Environmental
      Protection Agency (EPA) s Chemical Safety for Sustainability (CSS) program (EPA 2012) and the
      National Institutes of Environmental Health Sciences (NIEHS) Strategic Plan for 2012-2017
      (NIEHS 2012). Leading up to the Strategic Plan, specific research priorities related to
      exposure assessment were identified in the 2011 NIEHS workshop Advancing Research on
      Mixtures: New Perspectives and Approaches for Predicting Adverse Human Health Effects",

      including the need to evaluate the utility of existing instruments that classify or quantify
      exposures, develop better tools to improve exposure assessment, and to better understand the
      nature of combined exposures (e.g., mixtures). This project will inform research priorities
      identified in the NIEHS strategic plan and several specific research needs discussed during
      the 2011 NIEHS workshop on mixtures, with a focus on assessing exposures from personal care
      and household products:

        -  Evaluate current exposure assessment technologies, including questionnaires

        -  Develop better models that link source with behavior to predict exposure

        -  Analyze combined exposures

        -  Evaluate usefulness of commercially available product use/marketing databases

        -  Evaluate prediction models

        -  Characterize behavior that impact exposures using new technologies (iPad/internet use)

      Personal care products (PCPs) and other household/consumer products are of particular
      interest because of the efficiency of their delivery and widespread use. Exposure to
      chemicals in PCPs can result through either direct or indirect routes of contact depending on
      the use of the product (Dodson 2012; Koniecki et al. 2011; Rudel et al. 2003; Schettler 2006;
      Weschler and Nazaroff 2014). Health concerns exist about some chemicals found in PCPs and
      household setting. Over the course of a lifetime, the average consumer may encounter tens of
      thousands of chemicals used as ingredients in consumer products, many of which are
      proprietary; thus, getting a complete picture of the human exposome is challenging. Given the
      large number of co-occurring chemicals in these products, new strategies, tools, and

      techniques need to be developed and evaluated for their utility in assessing exposure to the
      multitude (tens of thousands) of chemicals representing the reality of exposure. Innovative
      tools need to be evaluated for their potential contributions to exposure assessment through
      rapid, cost-efficient methods which allow the simultaneous measurement of multiple chemical
      agents and gathering of contextual information to inform exposure reduction. These integrated
      tools and techniques can then be used to refine measurement and predictive modeling methods
      that support high throughput chemical analysis and exposure assessment.

      The proposed research concept represents collaboration between NIEHS (Division of the
      National Toxicology Program, Division of Intramural Research, and the Clinical Research Unit)
      and the EPA Office ofResearch and Development (ORD). The partnership includes co- funding
      with EPA, the sharing of equipment and expertise, and the use of EPA field teams for
      extensive collection of exposure information.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Individuals will be recruited from the RTP area, since they will be required to complete
        home and clinic visits as part of their study participation.@@@@@@
      
Keywords: Exposure Assessment; Questionnaire; Product Use; Biomonitoring; Natural History