Document ID: EPA-HQ-OPA-2007-0042-0025
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2020-11-05T05:00Z

APPENDIX B
	This Appendix contains the script that EPA's contractor followed during consultation calls conducted under the Paperwork Reduction Act for the renewal of EPA ICR No. 1664.12, OMB No. 2050-0141.
                       NCP Subpart J Consultation Script
Hello [Contact Name], my name is [Contractor Name], and I work for GDIT. We are a contractor for the U.S. Environmental Protection Agency (EPA). Every three years, EPA updates its estimates for paperwork-related burden for implementing the National Oil and Hazardous Pollution Contingency Plan (NCP), Subpart J (40 CFR 300.900), "Use of Dispersants and Other Chemicals" regulation. Subpart J requirements include criteria for listing oil spill mitigating agents on the NCP Product Schedule. 
EPA is seeking assistance to determine reasonable burden hours for completing Subpart J listing paperwork and costs for toxicity and effectiveness testing as part of EPA's current three-year ICR update. Note that the questions relate specifically to administrative or paperwork-related activities associated with Subpart J NCP Product Schedule listing compliance, not capital or O&M costs associated with research and development.
We estimate that this interview should take no more than 20 minutes and we greatly appreciate your willingness to provide insight based on your experience.

First, I will ask some general background questions to understand your experience with NCP Subpart J.

 [For LABORATORIES:]

 What is your position at [Lab Name]?

 Based on previous NCP Product Schedule listing applications, it is our understanding that [Lab Name] provides testing services to manufacturers who plan to submit a product to EPA for listing on the NCP Product Schedule. Is that correct?

 Would it be helpful to review the NCP Subpart J Product Schedule listing requirements and testing protocols?
   [If NO, continue to question 1d. If YES, provide the following information:

   To have a product listed on the Schedule, Subpart J requires that the manufacturer conduct specific toxicity and effectiveness tests and submit the corresponding technical product data and other required information to the EPA's NCP Product Schedule Manager. Specifically, 
 EPA requires manufacturers to test dispersants (40 CFR 900.915(a)(8)), surface washing agents (40 CFR 300.915 (b)(7)), surface collecting agents (40 CFR 300.915 (c)(7)), and miscellaneous oil spill control agents (40 CFR 300.915 (f)(8)) for toxicity using the standard toxicity methods described in Appendix C of the NCP regulation. 
               
 EPA requires manufacturers to test dispersants for effectiveness using the Swirling Flask Effectiveness test described in Appendix C of the NCP regulation (40 CFR 300.915 (a)(7)). Only those dispersants that meet or exceed the established threshold will be listed on the Schedule. 
               
 EPA requires respondents to test bioremediation agents for effectiveness, using the testing protocol described in Appendix C of the NCP regulation (40 CFR 300.915 (d)(7)).]
      
 Approximately how many Subpart J testing requests have you worked on over the last five years [or another period (annually) if needed to provide an estimate]? 

 What does your lab charge for the following three NCP Subpart J tests: 1) Toxicity Test; 2) Swirling Flask Dispersant Effectiveness Test; and 3) Bioremediation Effectiveness Test?
            
 How do you price testing services? By time and materials (T&M), fixed price, or another pricing structure?
[When the interview is over, thank the contact for their time and assistance.]
 [For MANUFACTURERS:]

 What is your position at [Manufacturer Name]?

 Based on the November 2019 NCP Product Schedule, it is our understanding that [Manufacturing Company] has submitted required information to EPA for listing a product. Is that correct?

 Would it be helpful to review the NCP Subpart J Product Schedule listing requirements?
   [If NO, continue to question 2d. If YES, provide the following information:
   To have a product listed on the Schedule, Subpart J requires that the manufacturer conduct specific toxicity and effectiveness tests and submit the corresponding technical product data and other required information to the EPA's NCP Product Schedule Manager. Specifically, 
 EPA requires manufactures submit listing materials as required in 40 CFR 900.915 and 40 CFR 900.920, using the format described in Appendix C, item 6.0 Summary Technical Product Test Data Format of the NCP regulation.
               
 [Note: Manufacturers of bioremediation agents are not required to conduct toxicity tests] EPA requires manufacturers to test dispersants (40 CFR 900.915(a)(8)), surface washing agents (40 CFR 300.915 (b)(7)), surface collecting agents (40 CFR 300.915 (c)(7)), and miscellaneous oil spill control agents (40 CFR 300.915 (f)(8)) for toxicity using the standard toxicity methods described in Appendix C of the NCP regulation. 
               
 [Note: For manufacturers of dispersants] EPA requires manufacturers to test dispersants for effectiveness using the Swirling Flask Effectiveness test described in Appendix C of the NCP regulation (40 CFR 300.915 (a)(7)). Only those dispersants that meet or exceed the established threshold will be listed on the Schedule. 
               
 [Note: For manufacturers of bioremediation agents] EPA requires respondents to test bioremediation agents for effectiveness, using the testing protocol described in Appendix C of the NCP regulation (40 CFR 300.915 (d)(7)).]

 Approximately how many Subpart J listing submissions have you worked on over the last five years [or another period (annually) if needed to provide an estimate]? This would include product listings that you have submitted to EPA.

 In advance of this call, we provided you with burden estimates required to compile NCP Subpart J listing information. It would be helpful for you to refer to the email as I go over the next set of questions. Subpart J listing submissions must include the data items in Table 1. EPA previously estimated burden hours for responding to the requirements. How do these burden hours compare to your personal experience? We understand that this assessment is based on your personal experience and that manufacturer-specific factors may result in different values, but please do your best to think about an average value for a typical application you have prepared and submitted. [Go through each activity and compile their responses. If they cannot provide burden hours by activity, ask for their overall total time estimate.]

                Table 1: Data Items Required Under NCP Subpart J
 
                              RESPONSE DATA ITEMS
                                  BURDEN HOURS
                           OIL SPILL MITIGATING AGENT

                                       BA
                                       D
                                       MA
                                      SCA
                                      SWA
 Name, brand, or trademark, if any, under which the product is sold
                                    0 to 0.5
                                       X
                                       X
                                       X
                                       X
                                       X
 Name, address, and telephone number of the manufacturer, importer or vendor

                                       X
                                       X
                                       X
                                       X
                                       X
 Name, address and telephone number of primary distributors or sales outlets

                                       X
                                       X
                                       X
                                       X
                                       X
 Special handling information and worker precautions for storage and field application, including maximum and minimum storage temperatures
                                    0.5 to 1
                                       X
                                       X
                                       X
                                       X
                                       X
 Shelf life information
                                    0 to 0.5
                                       X
                                       X
                                       X
                                       X
                                       X
 Recommended application procedures, concentrations, and conditions for use
                                    0.5 to 1
                                       X
                                       X
                                       X
                                       X
                                       X
 Results of the effectiveness test set forth in Appendix C of the NCP
                                   2.0 to 5.0
                                       X
                                       X
                                        
                                        
                                        
 Result of the toxicity test set forth in Appendix C of the NCP
                                   2.0 to 5.0
                                        
                                       X
                                       X
                                       X
                                       X
 Physical properties covered by the American Society for Testing and Materials (ASTM) reference standards
                                    0.5 to 1
                                        
                                       X
                                       X
                                       X
                                       X
 Test results for distinguishing surface collecting agents from other chemical agents
                                    0.5 to 1
                                        
                                        
                                        
                                       X
                                        
 List of product components 
                                   2.0 to 5.0
                                        
                                       X
                                       X
                                       X
                                       X
 The concentrations or upper limits of any heavy metals, cyanide, and chlorinated hydrocarbons
                                    0.5 to 1
                                        
                                       X
                                       X
                                       X
                                       X
 Information on microbiological cultures, enzyme additives, and nutrient additives 
                                   2.0 to 5.0
                                       X
                                        
                                       X
                                        
                                        
 Identity of laboratory performing tests, the qualifications of the laboratory staff, and laboratory experience with similar tests
                                   2.0 to 5.0
                                       X
                                       X
                                       X
                                       X
                                       X
  KEY:  BA = Bioremediation Agent, D = Dispersant, MA = Miscellaneous Agent, SCA= Surface Collecting Agent, and SWA = Surface Washing Agent
[When the interview is over, thank the contact for their time and assistance.]