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                             SUPPORTING STATEMENT
                                       
                EFFLUENT LIMITATIONS GUIDELINES AND STANDARDS 
                            FOR THE DENTAL CATEGORY
                                  FINAL RULE
                                       
                            EPA ICR NUMBER 2514.03
                                       
                                       
                     U.S. Environmental Protection Agency
                                Office of Water
                        Office of Wastewater Management
                                       
                                       
                                       
                                       
                                April 21, 2020


Contents
A.  Justification.	5
1.	Explain the circumstances that make the collection of information necessary.  Identify any legal or administrative requirements that necessitate the collection.	5
2.	Indicate how, by whom, and for what purpose the information is to be used.  Except for a new collection, indicate the actual use the agency has made of the information received from the current collection.	6
3.	Describe whether, and to what extent, the collection of information involves the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g. permitting electronic submission of responses, and the basis for the decision for adopting this means of collection.  Also describe any consideration of using information technology to reduce burden.	6
4.	Describe efforts to identify duplication.  Show specifically why any similar information already available cannot be used or modified for use for the purpose(s) described in item 2 above.	6
5.	If the collection of information impacts small businesses or other small entities, describe the methods used to minimize burden.	7
6.	Describe the consequence to federal program or policy activities if the collection is not conducted or is conducted less frequently, as well as any technical or legal obstacles to reducing burden.	7
7.	Explain any special circumstances that would cause an information collection to be conducted in a manner:	7
8.	If applicable, identify the date and page number of publication in the Federal Register of the Agency's notice, required by 5 CFR 1320.8(d), soliciting comments on the information collection prior to submission to OMB.	8
9.	Explain any decision to provide any payment or gift to respondents, other than remuneration of contractors or grantees.	9
10.	Describe any assurance of confidentiality provided to respondents and the basis for the assurance in statute, regulation, or agency policy.	9
11.	Provide additional justification for any questions of a sensitive nature, such as sexual behavior and attitudes, religious beliefs, and other matters that are commonly considered private.  This justification should include the reasons why the agency considers the questions necessary, the specific uses to be made of the information, the explanation to be given to persons from whom the information is requested, and any steps to be taken to obtain their consent.	10
12.	Provide estimates of the hour burden of the collection of information. The statement should:	10
13.	Provide an estimate of the total annual cost burden to respondents or recordkeepers resulting from the collection of information. (Do not include the cost of any hour burden shown in items 12 and 14).	12
14.	Provide estimates of annualized cost to the federal government.	12
15.	Explain the reason for any program changes or adjustments in burden estimates from the previous approved ICR.	14
16.	For collections of information whose results will be published, outline plans for tabulation, and publication.  Address any complex analytical techniques that will be used.  Provide the time schedule for the entire project, including beginning and ending dates of the collection of information, completion of report, publication dates, and other actions.	14
17.	If seeking approval to not display the expiration date for OMB approval of the information collection, explain the reasons that display would be inappropriate.	14
18.	Explain each exception to the certification statement identified in item 19, "Certification for Paperwork Reduction Act Submissions," in ROCIS.	14
Appendix A  -  One-Time Compliance Reporting Form Template	15



Terms of Clearance:

None. 

A.  Justification.

Explain the circumstances that make the collection of information necessary.  Identify any legal or administrative requirements that necessitate the collection. 
       
          The EPA has promulgated standards under the Clean Water Act (CWA) to reduce discharges of mercury from dental offices into municipal sewage treatment plants known as publicly owned treatment works (POTWs). Mercury is discharged in the form of dental amalgam when dentists remove old amalgam fillings from cavities, and from excess amalgam removed when a dentist places a new filling. 
    
          The rule requires affected dental offices to control mercury discharges to POTWs by reducing their discharge of dental amalgam to a level achievable through the use of the best available technology or best available demonstrated control technology. Specifically, dental offices will have to use amalgam separators and the use of two best management practices (BMPs)  -  a prohibition on the discharge of waste (or "scrap") amalgam to POTWs and a prohibition of the use of vacuum line cleaners that are oxidizing or acidic and that have a pH higher than 8 or lower than 6. 
          
          Dental dischargers are required to certify in a One-Time Compliance Report that they 1) do not remove amalgam except in limited emergency or unplanned, unanticipated circumstances and do not use amalgam; or 2) that they are complying with the standards specified in the rule. They also must maintain on-site all records of compliance, as described in the regulation, and make them available for inspection, upon request. 
          
          This ICR is seeking to continue to collect the data elements required in the regulation, as described in § 441.50(a). The EPA has created a form to serve as a sample one-time compliance report that Control Authorities may use for collection of the information required in the regulation. This ICR defines the minimum that needs to be collected, but it does not specify the full breadth of information or the format in which it is collected. Control Authorities may use their own form, provided it meets the requirements of the regulation. To summarize the information requested in the compliance form, the following section headers are highlighted below with their corresponding regulation requirement:

General Information: § 441.50(a)(3)(ii)(A) and § 441.50(a)(3)(ii)(B)
Applicability: § 441.50(a)(3)(i), § 441.50(a)(4), and § 441.10
Section A, Description of Facility: § 441.50(a)(3)(ii)(C)
Section B, Description of Amalgam Separator or Equivalent Device: § 441.50(a)(3)(ii)(C)
Section C, Design, Operation and Maintenance of Amalgam Separator/Equivalent Device: § 441.50(a)(3)(ii)(D) and § 441.50(a)(3)(ii)(F)
Section D, Best Management Practices (BMP) Certifications: § 441.50(a)(3)(ii)(E)
Section E, Certification Statement: § 441.50(a)(2)
Retention Period: § 441.50(a)(5)
          
          The final rule included a provision to significantly reduce and streamline the oversight and requirements that would otherwise apply as a result of this rulemaking. Control Authorities (which may be POTWs, states or the EPA) are responsible for oversight of the pretreatment standards. Oversight will be accomplished largely through the review of reports submitted by the dental offices. 
          
          The EPA promulgated this regulation under the authorities of sections 101, 301, 304, 306, 307, 308, and 501 of the CWA, 33 U.S.C. §§ 1251, 1311, 1314, 1316, 1317, 1318, 1342 and 1361 and pursuant to the Pollution Prevention Act of 1990, 42 U.S.C. § 13101 et seq.  

Indicate how, by whom, and for what purpose the information is to be used.  Except for a new collection, indicate the actual use the agency has made of the information received from the current collection.
      
          This is a collection renewal.
          
          Control Authorities review the reports and records of compliance to assess dental facilities' compliance with the pretreatment standards.
      
Describe whether, and to what extent, the collection of information involves the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g. permitting electronic submission of responses, and the basis for the decision for adopting this means of collection.  Also describe any consideration of using information technology to reduce burden.  
          
          The collection of information does not specify the use of automated, electronic, mechanical, or other technological collection techniques nor does it prevent the use of such techniques. During the development of the rule, the EPA received several comments requesting that an electronic compliance reporting system be developed. These commenters generally advocated for electronic reporting due to the size of the industry and the proposed annual reporting requirement. The EPA ultimately decided not to specify electronic reporting in the final rule after it determined the final rule would only require a One-Time Compliance Report from each affected dental discharger. 
          
Describe efforts to identify duplication. Show specifically why any similar information already available cannot be used or modified for use for the purpose(s) described in item 2 above.

          The rule does not duplicate other information requirements. Dental dischargers to POTWs have not previously been subject to reporting requirements for categorical dischargers, and therefore they were not required to submit the reports/certifications. There are no public sources available from which a Control Authority would be able to obtain this information.

If the collection of information impacts small businesses or other small entities, describe the methods used to minimize burden.
      
      	The final rule included a provision to significantly reduce and streamline the reporting requirements in EPA's General Pretreatment Regulations that would otherwise apply as a result of this rulemaking. Most significantly, it eliminated dental discharger biannual reporting and wastewater sampling. Instead, it requires dental dischargers to submit a One-Time Compliance Report as described in Section A.1. 
      
Describe the consequence to federal program or policy activities if the collection is not conducted or is conducted less frequently, as well as any technical or legal obstacles to reducing burden.
          
          Dental offices were not previously required to report the characteristics of their discharges to Control Authorities. As the rule requires a One-Time Compliance Report only, data submission less frequent than the One-Time Compliance Report would prevent Control Authorities from knowing if dentists meet the requirements of the rule. Further, this ICR presumes that all existing dental offices have submitted the One-Time Compliance Report; therefore, this requirement will only apply to new dental offices which open during the ICR period and offices which transfer ownership during the ICR period.
      
Explain any special circumstances that would cause an information collection to be conducted in a manner:  

           -	requiring respondents to report information to the agency more often than quarterly; 
           
           -	requiring respondents to prepare a written response to a collection of information in fewer than 30 days after receipt of it;
           
           -	requiring respondents to submit more than an original and two copies of any document; 
           
           -	requiring respondents to retain records, other than health, medical, government contract, grant-in-aid, or tax records for more than 3 years;
           
           -	in connection with a statistical survey, that is not designed to produce valid and reliable results that can be generalized to the universe of study;
           
           -	requiring the use of a statistical data classification that has not been reviewed and approved by OMB;
           
            That includes a pledge of confidentiality that is not supported by authority established in statue or regulation, that is not supported by disclosure and data security policies that are consistent with the pledge, or which unnecessarily impedes sharing of data with other agencies for compatible confidential use; or
           
            Requiring respondents to submit proprietary trade secret, or other confidential information unless the agency can demonstrate that it has instituted procedures to protect the information's confidentiality to the extent permitted by law. 
      
        		The final rule contains a provision that may require a dental discharger to maintain the One-Time Compliance Report for longer than three years. The rule requires that as long as the dental discharger is in operation or ownership is transferred, the discharger must maintain the One-Time Compliance Report. Other than this requirement, the rule does not involve any of the above described special circumstances.
      
If applicable, identify the date and page number of publication in the Federal Register of the Agency's notice, required by 5 CFR 1320.8(d), soliciting comments on the information collection prior to submission to OMB.  
      
      	Summarize public comments received in response to that notice and describe actions taken by the agency in response to these comments. Specifically address comments received on cost and hour burden any special circumstances that would cause an information collection to be conducted in a manner:  

           -	describe efforts to consult with persons outside the agency to obtain their views on the availability of data, frequency of collection, the clarity of instructions and recordkeeping, disclosure, or reporting format (if any), and on the data elements to be recorded, disclosed, or reported.
           
           - consultation with representatives of those from whom information is to be obtained or those who must compile records should occur at least once every 3 years -- even if the collection of information activity is the same as in prior periods.  There may be circumstances that may preclude consultation in a specific situation.  These circumstances should be explained.
      
            A summary of the associated ICRs and requests for public comment were included in the Federal Register notice for the proposed rule (79 FR 63282, October 22, 2014) and for the final rule (82 FR 27154, July 14, 2017).
           
            The EPA received numerous comments related to burden in the proposed rule (79 FR 63282, October 22, 2014), particularly from POTWs (many of which are Control Authorities). These commenters largely supported the reduced oversight requirements in the proposal but encouraged the EPA to reduce them further so that dental offices would never be significant industrial users (SIUs), primarily due to concerns over the associated burden given the large number of dental offices potentially subject to the rule. In addition, they raised concerns that they would have to update state and local laws to take advantage of the proposed changes to part 403 that would reduce the oversight requirements. They also raised concerns about additional reporting requirements for the Control Authorities typically associated with categorical industrial users (CIUs), such as identifying CIUs in their annual pretreatment report to the Approval Authority. 
            
            In response, the EPA did not revise the General Pretreatment Standards to create the proposed dental industrial user (DIU) category and associated requirements. Rather, the final dental rule establishes for the purposes of Part 441, that dental dischargers are not SIUs or CIUs as defined in 40 CFR 403 unless designated as such by the Control Authority. This regulatory structure achieves the same goal as the proposed revisions to the General Pretreatment Standards without creating a need for updates to state and local laws. By establishing that dental dischargers are not SIUs or CIUs in the final rule, the EPA eliminates the application of specific oversight and reporting requirements in 40 CFR Part 403 such as permitting and annual inspections of dental dischargers for SIUs and CIUs unless the Control Authority chooses to apply these requirements to dental offices. This means that Control Authorities have discretion under the final rule to determine the appropriate manner of oversight, compliance assistance, and enforcement. Further, the final rule reduced reporting for dental offices (and associated oversight requirements by Control Authorities) in comparison to reporting requirements for other industries subject 	to categorical pretreatment standards, as it requires only a One-Time Compliance Report be submitted to the Control Authority. The One-Time Compliance Report requirements specific to dental dischargers were included in this rule rather than in the General Pretreatment regulations so that they may be implemented directly. 
         
Explain any decision to provide any payment or gift to respondents, other than remuneration of contractors or grantees.  
      
            The rule does not involve any payments or gifts to respondents.
      
Describe any assurance of confidentiality provided to respondents and the basis for the assurance in statute, regulation, or agency policy.

            Reports submitted to the Control Authority may contain confidential business information. However, the EPA does not consider the specific information being requested by the rule to be typical of confidential business or personal information. If a respondent does consider this information to be of a confidential nature, the respondent may request that such information be treated as such. All confidential data will be handled in accordance with 40 CFR 122.7, 40 CFR Part 2, and EPA's Security Manual Part III, Chapter 9, dated August 9, 1976.
           
Provide additional justification for any questions of a sensitive nature, such as sexual behavior and attitudes, religious beliefs, and other matters that are commonly considered private.  This justification should include the reasons why the agency considers the questions necessary, the specific uses to be made of the information, the explanation to be given to persons from whom the information is requested, and any steps to be taken to obtain their consent.
      
            The rule does not require respondents to divulge information of a sensitive nature, such as private or personal information.
      
Provide estimates of the hour burden of the collection of information. The statement should:
      
            Hour Burden for Dentists: The EPA estimates an average of 122,741 dental offices would be subject to this ICR. It is presumed that all existing dental offices which place or remove amalgam have submitted the required One-Time Compliance Report. However, in the event a new dental office opens or a regulated dental discharger transfers ownership, the new owner must submit a One-Time Compliance Report (estimated to take 76 minutes per dental office). The EPA estimated a one percent growth rate for new dental offices and presumed that 10 percent of dental offices which place or remove amalgam may transfer ownership each year. As explained previously, the EPA notes a One-Time Compliance Report is a reduction in burden that dental offices would otherwise experience under the reporting requirements that would apply to industrial users subject to an industry category regulation in 40 CFR Part 403. For One-Time Compliance Reports required for newly opened dental offices, the EPA estimated an average annual labor of 1,565 hours per year. For transfers of ownership, the EPA estimated an average labor of 13,946 hours per year. 

            For recordkeeping, the EPA estimates that an average of 110,496 offices, which represents the subset of the dental offices that place or remove amalgam, would have recordkeeping costs. Offices that use or remove amalgam would need to keep on-site records of maintenance-related recordkeeping, recycling-related recordkeeping, and inspection-related recordkeeping. The EPA estimates that one percent of dental offices will need a repair for their amalgam separator and will need to keep a record of it. For recordkeeping, the EPA estimates 200 minutes of burden per dental office, for an average annual labor of 368,874 hours per year.
            
            The average annual labor for reporting and recordkeeping over a three-year period is 384,384 hours. See Table 1.
      
            Hour Burden for Control Authorities:  The costs to Control Authorities for review of the reports required by the final rule were significantly reduced from the pretreatment regulatory requirements found at 40 CFR Part 403. As explained above, because the final dental rule establishes that dental dischargers are not SIUs or CIUs, the required incremental oversight includes receipt of reports and other transfer of ownership notices submitted by dischargers. 
      
            As described above, the entity serving the role as the Control Authority varies.  For purposes of this burden estimate, the EPA estimates 37 States and 1,600 POTWs may serve as Control Authorities for Dental Dischargers. For purposes of this ICR renewal, the EPA assumed no Control Authorities would elect to perform oversight not required as a result of this final rule.  
            
            The EPA estimated a one-time burden of 45 minutes associated for Control Authorities to review and file each One-Time Compliance Report for ownership transfers and for newly opened dental offices. For One-Time Compliance Reports initiated due to transfer in ownership, the EPA estimated an average annual labor of 7,256 hours per year. For newly opened dental offices, the EPA estimated an average annual labor of 924 hours per year. 
            
            The average annual labor for control authority oversight over a three-year period is 8,262 hours. See Table 2.
            
            Costs to Dentists: The EPA estimated reporting costs for the average 110,496 dental offices for the specific activities related to the reporting requirements of the final rule. The EPA estimated the labor costs for the proposed reporting requirements on average wages as reported for dental assistants from the Bureau of Labor Statistics in May 2018 ($19.12/hour), which was adjusted to include total compensation per guidance from the Bureau of Labor Statistics ($27.31/hour). The EPA used the estimated hours required to respond to the requirements of the final rule and multiplied these costs by this labor rate. The EPA estimated an average annual labor cost of $37,710 per year for the One-Time Compliance Reporting initiated by the opening of new dental offices. For transfers of ownership, the EPA estimated an average annual labor cost of $380,912 per year. The EPA estimates an average annual labor cost of $10,075,516 for recordkeeping.  
            
            Costs to Control Authorities:  The EPA estimated Control Authority costs for the specific activities related to oversight requirements. The EPA based the labor costs for Control Authorities on average total compensation as reported for Control Authorities in Effluent Limitation Guidelines and Standards for the Metal Products and Machinery Category because this rule reported collected information on labor rates from Control Authorities. These costs reflect 1999 dollars. The EPA took the 1999 labor rate and used the Employment Cost Index for State and Local Government Public Administration (https://www.bls.gov/ncs/ect/escalator.htm) and converted the labor rate to 2019 dollars ($63.39/hour). The EPA used the estimated hours associated with oversight of the final rule and multiplied these costs by the 2019 labor rate. Where POTWs and states are Control Authorities, the EPA estimated the annual average recordkeeping costs associated with One-Time Compliance Reporting for newly opened dental offices and those initiated by transfers of ownership to be $558,300. 
            
Provide an estimate of the total annual cost burden to respondents or recordkeepers resulting from the collection of information. (Do not include the cost of any hour burden shown in items 12 and 14).
            
            The majority of the burden and cost calculations in this ICR are the result of labor costs only. The ICR does, however, account for O&M costs to dental offices for reporting postage (average annual cost of $6,555) and to Control Authorities for storage of files (average annual cost of $3,116). 
            
            See Tables 1 and 2 for O&M and labor costs for dental offices and Control Authorities respectively. 
            
Provide estimates of annualized cost to the federal government.  
      
            Also, provide a description of the method used to estimate cost, which should include quantification of hours, operation expenses (such as equipment, overhead, printing, and support staff), and any other expense that would not have been incurred without this collection of information.  Agencies also may aggregate cost estimates from items 12, 13, and 14 in a single table.
      
            Where the EPA is the Control Authority, the EPA will incur costs and burdens described for Control Authorities above. In a similar manner, the EPA estimated that it would incur annual average recordkeeping costs associated with One-Time Compliance Reporting for newly opened dental offices and those initiated by transfer of ownership to be $72,296. 

Table 1.  Estimated Dental Office O&M Burden and Labor Costs for New Dental Offices and Transfer of Ownership and Recordkeeping (Questions 12 and 13)
Year / Activity
                       Estimated Burden Hours per Office
                     Estimated Cost Burden per Office [a]
                 Number of Dental Offices Conducting Activity
                                     Hours
                                    Dollars
Year 1 - One-time Compliance Form/Certification Form (New Offices)
                                     1.27
                                      $35
                                     1,223
                                     1,549
                                   
$42,984
Year 1 - Recordkeeping (Annual Cost)
                                     3.34
                                      $91
                                    109,403
                                    365,223
                                  $9,975,792
Year 1 - Transfer of Ownership (Annual Cost)
                                     1.27
                                      $35
                                    10,900
                                    13,807
                                   $383,123
Year 1 - Total Annual 
                                       
                                       
                                    121,526
                                    380,579
                                  $10,401,900
Year 2 - One-time Compliance Form/Certification Form (New Offices)
                                     1.27
                                      $35
                                     1,235
                                     1,565
                                   
$43,414
Year 2 - Recordkeeping (Annual Cost)
                                     3.34
                                      $91
                                    110,493
                                    368,861
                                  $10,075,185
Year 2 - Transfer of Ownership (Annual Cost)
                                     1.27
                                      $35
                                    11,009
                                    13,945
                                   $386,955
Year 2 - Total Annual 
                                       
                                       
                                    122,737
                                    384,371
                                  $10,505,554
Year 3 - One-time Compliance Form/Certification Form (New Offices)
                                     1.27
                                      $35
                                     1,248
                                     1,580
                                   
$43,848
Year 3 - Recordkeeping (Annual Cost)
                                     3.34
                                      $91
                                    111,594
                                    372,537
                                  $10,175,572
Year 3 - Transfer of Ownership (Annual Cost)
                                     1.27
                                      $35
                                    11,119
                                    14,085
                                   $390,824
Year 3 - Total Annual 
                                       
                                       
                                    123,960
                                    388,201
                                  $10,610,245
3-Year Average: All Activities
                                       
                                       
                                    122,741
                                    384,384
                                  $10,505,899
3-Year Average: One-time Compliance Form/Certification Form (New Offices)
                                       
                                       
                                     1,235
                                     1,565
                                    $43,416 
3-Year Average: Recordkeeping (Annual Cost)
                                       
                                       
                                    110,496
                                    368,874
                                  $10,075,517 
3-Year Average: Transfer of Ownership (Annual Cost)
                                       
                                       
                                    11,010
                                    13,946
                                   $386,967 
a  -  Labor rate of $27.31 per hour for a dental assistant derived from Bureau of Labor Statistics (May 2018).
 May not add due to rounding
      
Table 2:  Estimated Control Authority (States and POTWs) Oversight O&M Burden and Labor Costs (Questions 12 and 13)
                                      Activity
                            Total Estimated Burden
                                     Hours
                         Total Estimated Cost Burden 
Total Costs in Year 1
                                     8,180
                                   $554,496
Total Costs in Year 2
                                     8,262
                                   $560,025
Total Costs in Year 3
                                     8,344
                                   $565,609
Total Average Annual Cost over Three-year period
                                     8,262
                                   $560,043
 May not add due to rounding
      

Table 3. Summary of Total Burden and Costs for Respondents (Dentists) and Control Authorities (States and POTWs) Annually Over Three Years

                                  Respondents
                             Annual Average Burden
                                    (Hours)
                             Annual Average Costs
Dental Offices
                                    122,741
                                    384,384
                                  $10,505,899
Control Authority (POTWs and States)
                                     1637
                                     8,262
                                     $560,043
TOTAL Average Annual Over Three Years
                                       
                                  392,646‬
                                  $11,065,942
 May not add due to rounding

      
Explain the reason for any program changes or adjustments in burden estimates from the previous approved ICR.
      
            The labor hours decreased since the last OMB approved ICR. However, the number of respondents and the labor rates increased. Therefore, the overall burden increased. The EPA presumed a one percent growth rate in dental offices and that only new dental offices and dental offices transferring ownership will be doing the One-Time Compliance Reporting. However, the EPA revised labor rates to 2018 dollars and included total compensation rather than just wages. 
      
         For collections of information whose results will be published, outline plans for tabulation, and publication. Address any complex analytical techniques that will be used.  Provide the time schedule for the entire project, including beginning and ending dates of the collection of information, completion of report, publication dates, and other actions.
      
            The data will be used by Control Authorities for compliance and enforcement purposes. There are no plans for publication of the data.
      
If seeking approval to not display the expiration date for OMB approval of the information collection, explain the reasons that display would be inappropriate.
      
            The EPA is not seeking a waiver of the display requirements for the expiration date.
      
Explain each exception to the certification statement identified in item 19, "Certification for Paperwork Reduction Act Submissions," in ROCIS.

            There are no exceptions to the certification statements.
            

Appendix A  -  One-Time Compliance Reporting Form Template

                                    SAMPLE
               ONE-TIME COMPLIANCE REPORT FOR DENTAL DISCHARGERS
                         to Comply with 40 CFR 441.50
 Effluent Limitations Guidelines and Standards for the Dental Office Category

Instructions:
The following is a sample form that contains the minimum information dental facilities must submit in a one-time compliance report as required by the Effluent Limitations Guidelines and Standards for the Dental Office Category ("Dental Amalgam Rule"). Some dental facilities are not required to submit a one-time compliance report.  See the applicability section (§ 441.10) to determine if your facility is required to submit a one-time compliance report. This sample form has not been approved by OMB under the Paperwork Reduction Act, and is subject to change. 

Note to dental facilities: Do not fill out and submit this form unless directed to do so by your Control Authority. Please contact your Control Authority to determine what form to use. Your Control Authority may be your wastewater utility, your state wastewater agency, or the U.S. EPA Regional Office. For assistance in determining your Control Authority, please see EPA's website: www.epa.gov/eg/dental-effluent-guidelines.

General Information 
Name of Facility

Physical Address of Dental Facility

City:

State:

Zip:

Mailing Address

City:

State:

Zip:

Facility Contact 

Phone:

Email:

Names of Owner(s):

Names of Operator(s) if different from Owner(s):



Applicability: Please Select One of the Following
☐
This facility is a dental discharger subject to this rule (40 CFR Part 441) and it places or removes dental amalgam.
Complete sections A, B, C, D, and E
☐
This facility is a dental discharger subject to this rule and (1) it does not place dental amalgam, and (2) it does not remove amalgam except in limited emergency or unplanned, unanticipated circumstances.
Complete section E only
(Also, select if applicable) Transfer of Ownership (§ 441.50(a)(4))
☐
This facility is a dental discharger subject to this rule (40 CFR Part 441), and it has previously submitted a one-time compliance report. This facility is submitting a new One Time Compliance Report because of a transfer of ownership as required by § 441.50(a)(4).


Section A
Description of Facility
Total number of chairs:

Total number of chairs at which amalgam may be present in the resulting wastewater (i.e., chairs where amalgam may be placed or removed):

Description of any amalgam separator(s) or equivalent device(s) currently operated: 

                                    YES ☐
                                    NO ☐
The facility discharged amalgam process wastewater prior to July 14th, 2017 under any ownership.


Section B
Description of Amalgam Separator or Equivalent Device 
 ☐
The dental facility has installed one or more ISO 11143 (or ANSI/ADA 108-2009) compliant amalgam separators (or equivalent devices) that captures all amalgam containing waste at the following number of chairs at which amalgam placement or removal may occur:
Chairs:
 ☐
The dental facility installed prior to June 14, 2017 one or more existing amalgam separators that do not meet the requirements of § 441.30(a)(1)(i) and (ii) at the following number of chairs at which amalgam placement or removal may occur:
Chairs:

I understand that such separators must be replaced with one or more amalgam separators (or equivalent devices) that meet the requirements of § 441.30(a)(1) or § 441.30(a)(2), after their useful life has ended, and no later than June 14, 2027, whichever is sooner.
                                     Make
                                     Model
                             Year of installation
 
 
 
 
 
 
 
 
 
 
 
 
 ☐
My facility operates an equivalent device.
                                     Make
                                     Model
                             Year of installation
Average removal efficiency of equivalent device, as determined per § 441.30(a)(2)i- iii.
 
 
 

 
 
 

 
 
 

 
 
 



Section C
Design, Operation and Maintenance of Amalgam Separator/Equivalent Device 
☐
YES
I certify that the amalgam separator (or equivalent device) is designed and will be operated and maintained to meet the requirements in § 441.30 or § 441.40. 
A third-party service provider is under contract with this facility to ensure proper operation and maintenance in accordance with § 441.30 or § 441.40.

                                      ☐
YES
Name of third-party service provider (e.g. Company Name) that maintains the amalgam separator or equivalent device (if applicable):
                                       




                                      ☐
NO
If none, provide a description of the practices employed by the facility to ensure proper operation and maintenance in accordance with § 441.30 or § 441.40.



 Describe practices:







Section D 
Best Management Practices (BMP) Certifications
☐
The above named dental discharger is implementing the following BMPs as specified in § 441.30(b) or § 441.40 and will continue to do so.
     Waste amalgam including, but not limited to, dental amalgam from chair-side traps, screens, vacuum pump filters, dental tools, cuspidors, or collection devices, must not be discharged to a publicly owned treatment works (e.g., municipal sewage system).
     Dental unit water lines, chair-side traps, and vacuum lines that discharge amalgam process wastewater to a publicly owned treatment works (e.g., municipal sewage system) must not be cleaned with oxidizing or acidic cleaners, including but not limited to bleach, chlorine, iodine and peroxide that have a pH lower than 6 or greater than 8 (i.e. cleaners that may increase the dissolution of mercury).


Section E
Certification Statement
Per § 441.50(a)(2), the One-Time Compliance Report must be signed and certified by a responsible corporate officer, a general partner or proprietor if the dental facility is a partnership or sole proprietorship, or a duly authorized representative in accordance with the requirements of § 403.12(l). 
"I am a responsible corporate officer, a general partner or proprietor (if the facility is a partnership or sole proprietorship), or a duly authorized representative in accordance with the requirements of  § 403.12(l) of the above named dental facility, and certify under penalty of law that this document and all attachments were prepared under my direction or supervision in accordance with a system designed to assure that qualified personnel properly gather and evaluate the information submitted. Based on my inquiry of the person or persons who manage the system, or those persons directly responsible for gathering the information, the information submitted is, to the best of my knowledge and belief, true, accurate, and complete. I am aware that there are significant penalties for submitting false information, including the possibility of fine and imprisonment for knowing violations."
Authorized Representative Name (print name):  

Phone:

Email:







Authorized Representative Signature
Date



Retention Period; per § 441.50(a)(5)
As long as a Dental facility subject to this part is in operation, or until ownership is transferred, the Dental facility or an agent or representative of the dental facility must maintain this One Time Compliance Report and make it available for inspection in either physical or electronic form.

