Document ID: EPA-HQ-OPA-2007-0042-0027
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2020-11-05T05:00Z

ATTACHMENT A
                              Consultation Notes
 Bio-Aquatic Testing, Inc. Response [LABORATORY]
 The interviewee is the Owner, Vice President of Bio-Aquatic Testing, Inc.
 The interviewee confirmed this his company provides laboratory-testing services to manufacturers who plan to submit a product to EPA for listing on the NCP Product Schedule.
 The interviewee is familiar with existing protocols; and has reviewed the pending protocols several times. 
 The interviewee confirmed his company received approximately 12-15 Subpart testing requests over the last 5 years.
 The interviewee provided costs for the following tests:
 Toxicity Test - $4,000
 Swirling Flask Dispersant Effectiveness Test - $4,500
 Bioremediation Effectiveness Test - $18,000
 The interviewee uses a Time & Materials pricing structure and outside services for GCMS.
         
 Green Earth Naturally, LLC Response [MANUFACTURER]
 The interviewee is an Environmental Specialist and Business Development Manager for Green Earth Naturally, LLC.
 The interviewee confirmed his company has submitted required information to EPA for listing a product on the NCP Product Schedule.
 The interviewee is familiar with NCP Subpart J Product Schedule listing requirements, no review necessary.
 The interviewee submitted one product for listing as a bioremediation agent.
 The interviewee stated that from time of market analysis to time of listing, the total duration of effort was from October 2016 through April 2, 2018 (date of listing letter).
 Interviewee stated the Bioremediation Agent effectiveness testing services cost $18,000.
 Interviewee claimed burden hours in Table 1 as not representative of his personal experience. Specifically, he provided the following discrepancies:
            
               Exhibit 1: Data Items Required Under NCP Subpart J
 
                              RESPONSE DATA ITEMS
                                  BURDEN HOURS
                 Bioremediation Agent  -  Manufacturer Response
 Name, brand, or trademark, if any, under which the product is sold
                                    0 to 0.5
 Concurred with high end of EPA estimate.
 Name, address, and telephone number of the manufacturer, importer or vendor
                                        
                                        
 Name, address and telephone number of primary distributors or sales outlets
                                        
                                        
 Special handling information and worker precautions for storage and field application, including maximum and minimum storage temperatures
                                    0.5 to 1
 Product Safety Data Sheet (SDS) not compatible with data item. Cited 3 days and 2 people to compile the data
 Shelf life information
                                    0 to 0.5
 Concurred with high end of EPA estimate.
 Recommended application procedures, concentrations, and conditions for use
                                    0.5 to 1
 Cited 3 to 6 days and 2 people to compile the data.
 Results of the effectiveness test set forth in Appendix C of the NCP
                                   2.0 to 5.0
 Cited significant delays in receipt of lab results due to requests for revised lab reports to correct errors. Mr. Carroll did counter that if the reports coming in from the lab were correct, the burden estimated (2.0 to 5.0 hours) for completing the response item may be appropriate.
 Result of the toxicity test set forth in Appendix C of the NCP
                                   2.0 to 5.0
                                  Not required
 Physical properties covered by the American Society for Testing and Materials (ASTM) reference standards
                                    0.5 to 1
                                  Not required
 Test results for distinguishing surface collecting agents from other chemical agents
                                    0.5 to 1
                                  Not required
 List of product components 
                                   2.0 to 5.0
 Cited 2 days to compile the data.
 The concentrations or upper limits of any heavy metals, cyanide, and chlorinated hydrocarbons
                                    0.5 to 1
                                  Not required
 Information on microbiological cultures, enzyme additives, and nutrient additives 
                                   2.0 to 5.0
 Cited difficulties procuring a lab to test for pathogens, took 1 week to 10 days to find a lab and respond to EPA's request for data.
 Identity of laboratory performing tests, the qualifications of the laboratory staff, and laboratory experience with similar tests
                                   2.0 to 5.0
 Concurred with EPA estimate.
                  
 JACOR, LLC Response [MANUFACTURER]
 The interviewee is the CEO of and product inventor for JACOR, LLC.
 The interviewee confirmed her company has submitted required information to EPA for listing a product on the NCP Product Schedule.
 The interviewee is familiar with NCP Subpart J Product Schedule listing requirements, no review necessary.
 The interviewee submitted one product for listing as a bioremediation agent.
 The interviewee responded to the request for an interview; however, she did not have time for a formal discussion. The respondent stated EPA's burden estimates in Table 1 were far less than her personal experience. Over an 18-month period, she provided three data resubmissions to comply with Subpart J requirements. Interviewee noted the testing costs for bioremediation agents were "prohibitive for a small company  -  nearly $20,000." Although she found the process frustrating and lengthy, she did "understand that the details, the laboratory reports, the process has a specific purpose for compliance with current regulations, yet we felt somewhat discriminated against as a small business who had never undertaken such an exercise with these government programs."  

 AGS Solutions, Inc. Response [MANUFACTURER]
 The interviewee is the President of AGS Solutions, Inc.
 The interviewee confirmed her company has submitted required information to EPA for listing a product on the NCP Product Schedule.
 The interviewee is familiar with NCP Subpart J Product Schedule listing requirements, no review necessary.
 The interviewee submitted three products for listing under the dispersant (one) and surface washing agent (two) categories.

 The interviewee cited burden hours in Tables 1 as not reflective of the time spent collecting and inputting the information. The interviewee assessed the total burden as 5 months from reading the rule to receiving the listing; and does consider the entire process as part of the burden estimate. Specifically, she cited the following discrepancies:
 Understanding Subpart J  -  Spent 1 week reading Subpart J in attempts to understand the data requirements (recommended EPA develop a flow chart, with timelines, to assist with following the regulation). 
 Request for Assistance  -  Spent 1 week trying to locate a point of contact to answer questions.
 Finding a Lab  -  Spent 1-2 weeks locating a lab. Interviewee used a known lab to her business  -  Smith-Chem. EPA reviewed the labs qualifications and accepted test results [required equipment to perform swirling flask test available, full understanding of Subpart J testing requirements, and experience with testing during rule development process]. 
 Testing  -  Lab had sample for 2 weeks. Interviewee considers wait time dealing with labs as part of the burden.
 Effectiveness test set forth in Appendix C of the NCP  -  Passed effectiveness threshold on first test run.           
 Toxicity test set forth in Appendix C of the NCP  -  No issues.
 Completing Data Requirements  -  Spent 2 weeks filling out the technical data summary.
 Preparing Application  -  Spent 1 week writing the cover letter.