Document ID: EPA-HQ-OPPT-2018-0611-0003
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2019-08-07T04:00Z

Supporting Statement for Paperwork Reduction Act Generic Information Collection Submissions for 
"TSCA Existing Chemical Risk Evaluation and Management; Generic ICR for Interviews and Focus Groups"

Part B.	STATISTICAL METHODS

 Universe and Respondent Selection
   
   Under this generic ICR, EPA will conduct focus groups and structured interviews with chemical users, processors, distributors, manufacturers (including importers), recyclers, chemical waste handlers, consumers, employees, state regulators, non-governmental organizations, and industry experts to gain critical information about chemicals that are candidates for risk evaluation or risk management under the Toxic Substances Control Act (TSCA). Results will not be used to produce statistical descriptions (careful, repeatable measurements).  The specific sample planned for each individual collection and the method for soliciting participation will be described fully in each collection request.  
   
   The data provided by interviews and focus groups under this generic ICR will be used to better understand conditions of use, exposure, potentially exposed and susceptible subpopulations, and alternatives to a particular chemical. This data may also be used to pretest survey instruments used in risk evaluation or risk management under TSCA.  The accuracy, reliability, and applicability of the results of these interviews and focus groups will be adequate for their purpose.
   
   In general, for conditions of use and exposure EPA's primary objectives are to obtain information about:  
 production volume and process information; 
 conditions of use;
 site release and transfer information (including disposal); 
 workplace exposure and practices in place to prevent or reduce worker exposure; 
 consumer exposure and practices in place to prevent or reduce consumer exposure (if applicable);  
 environmental exposure; 
 potentially exposed or susceptible populations; 
 chemical end uses, including products containing the chemical (if applicable); and 
 other information needed to identify conditions of use or exposures for the subject chemical or chemical category.  
      
   For alternatives, EPA's primary objectives are to obtain information about:  
 chemical and/or process alternatives for risk management of a given condition of use of a chemical;
 efficacy and performance of alternatives;
 experience and use practices with use of any alternative;
 advantages and disadvantages of any alternative; and
 other information needed to calculate costs and benefits of various alternatives.
   

 Procedures for Collecting Information
   
   Data collection methods and procedures will vary and the specifics of these will be provided with each collection request. 
   
 Methods to Maximize Response
   
   Information collected under this generic clearance will yield data about conditions of use, exposure, and alternatives to certain chemicals expected to require risk management. EPA will work with the universe of respondents to maximize response to gain valuable data.
   
 Testing of Procedures
    
   Pretesting may be done with internal staff, a limited number of external colleagues, and/or customers who are familiar with the chemicals, conditions of use, products and articles, as well with those familiar with the stakeholders. 
   
 Contacts for Statistical Aspects and Data Collection
   
   The data collected under this generic clearance will be adequate for its purpose and will not be used to produce statistical descriptions. Instead, the data collected will be used to better understand the conditions of use evaluated, associated exposures, or the alternatives to chemicals that present unreasonable risks in a risk evaluation and are expected to be the subject of risk management action under TSCA.  Data collected under this generic clearance may be used in several ways during the risk evaluation and risk management processes, including establishing generic scenarios, developing models of various conditions of use of chemicals evaluated under TSCA or their alternatives, and providing important context for publicly available information or other information already available to EPA.