INFORMATION COLLECTION REQUEST

SUPPORTING STATEMENT

EFFLUENT LIMITATIONS GUIDELINES AND STANDARDS 

FOR THE DENTAL CATEGORY

PROPOSED RULE

U.S. Environmental Protection Agency

Office of Water

Office of Science and Technology

September 22, 2014
i

TABLE OF CONTENTS

Page

PART A OF THE SUPPORTING STATEMENT ......................................................................... 1

1. Identification of the Information Collection........................................................... 1

a. Title of the Information Collection............................................................. 1

b. Short Characterization/Abstract.................................................................. 1

2. Need for and Use of the Collection......................................................................... 1

a. Need/Authority for the Collection .............................................................. 1

b. Practical Utility/Users of the Data .............................................................. 1

3. Non-Duplication, Consultations, and Other Collection Criteria............................. 2

a. Non-Duplication ......................................................................................... 2

b. Public Notice Required Prior to ICR Submission to OMB ........................ 2

c. Consultations............................................................................................... 2

d. Effects of Less Frequent Collection............................................................ 2

e. General Guidelines...................................................................................... 2

f. Confidentiality ............................................................................................ 3

g. Sensitive Questions..................................................................................... 3

4. The Respondents and the Information Requested .................................................. 3

a. Respondent NAICS Codes.......................................................................... 3

b. Information Requested................................................................................ 4

i. Data Items, Including Record Keeping Requirements.......................... 4

ii. Respondent Activities.......................................................................... 4

5. The Information Collected – Agency Activities, Collection Methodology, and 

Information Management........................................................................................ 4

a. Agency Activities........................................................................................ 4

b. Collection Methodology and Management................................................. 4

c. Small Entity Flexibility............................................................................... 5

d. Collection Schedule .................................................................................... 5

6. Estimating the Burden and Cost of the Collection.................................................. 5

a. Estimating Respondent Burden................................................................... 5

b. Estimating Respondent Costs ..................................................................... 5

i. Estimating Labor Costs......................Error! Bookmark not defined.6

ii. Estimating Capital and Operations and Maintenance (O&M) Costs... 8

iii. Annualizing Capital Costs .................................................................. 8

c. Estimating Agency Burden and Costs ........................................................ 8

d. Estimating the Respondent Universe and Total Burden Costs................... 8

e. Bottom Line Burden Hours and Cost Tables.............................................. 9

i. Respondent and Agency Burden Hours and Costs ............................... 9

ii. Variations in the Annual Bottom Line................................................. 9

f. Reasons for Change in Burden ................................................................... 9

g. Burden Statement........................................................................................ 9
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PART A OF THE SUPPORTING STATEMENT

1. Identification of the Information Collection

a. Title of the Information Collection

Effluent Limitations Guidelines and Standards (ELGs) for the Dental Category; Proposed 

Rule (40 CFR Part 441). EPA ICR No. 2514.01. OMB No. 2040-NEW.

b. Short Characterization/Abstract

This Information Collection Request (ICR) seeks approval of the information 

requirements in the Proposed Rule for the Effluent Guidelines and Standards for the Dental 

Category. EPA is proposing standards under the Clean Water Act (CWA) for discharges of 

pollutants into publicly owned treatment works (POTWs) from certain existing and new dental 

practices that involve the discharge of dental amalgam. 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 proposed rule would require all affected dentists 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 (amalgam separators) and the use of Best Management Practices. 

EPA is also proposing to amend selected parts of the General Pretreatment Regulations 

(40 CFR Part 403) to streamline oversight requirements for the dental sector and reduce the 

reporting burden for dental offices. 

2. Need for and Use of the Collection

a. Need/Authority for the Collection

EPA is proposing this regulation under the authorities of sections 101, 301, 304, 306, 

307, 308, and 501 of the Clean Water Act (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. 

b. Practical Utility/Users of the Data

The users of the data would be dental offices and their Control Authorities. By 

establishing categorical pretreatment standards for the dental category in 40 CFR Part 441, dental 

dischargers to POTWs would become subject to certain reporting requirements in 40 CFR Part 

403. These include a requirement to submit a baseline monitoring report, 90-day compliance 

report and on-going monitoring and reporting requirements including results of discharge 

sampling. Under the proposed rule, a dental discharger is given the option of complying with 

reduced monitoring and reporting requirements in 40 CFR § 441.60, which are tailored for dental 

dischargers, in lieu of the otherwise applicable monitoring and reporting requirements in 40 CFR 
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part 403. Dental offices electing to comply with the proposed reporting requirements would 

need to certify annually that they 1) operate and maintain a dental amalgam separator certified to 

the ISO 11143 standard and 2) are complying with the best management practices defined in the 

proposed rule. 

3. Non-Duplication, Consultations, and Other Collection Criteria

a. Non-Duplication

The rule does not duplicate other information requirements. Because dental dischargers 

to POTWs are not currently subject to reporting requirements for categorical dischargers, they 

are not currently required to submit the reports/certifications. There are no public sources 

available from which a control authority would be able to obtain this information.

b. Public Notice Required Prior to ICR Submission to OMB

A summary of the ICR for the rule is included in the Effluent Limitation Guidelines and 

Standards for the Dental Category Federal Register Notice. The values provided in the Federal 

Register Notice differ slightly from the numbers provided in this document. Specifically, EPA 

updated the values for Control Authorities.

c. Consultations

EPA met with stakeholders during the development of the proposed rule. Participants 

included the American Dental Association (ADA), and the National Association of Clean Water 

Agencies (NACWA), and the Environmental Council of the States. Stakeholders provided data 

on the characteristics of the dental industry, pollutant discharge characteristics, technologies and 

best management practices to reduce pollutant discharges, existing programs to reduce pollutants 

in dental discharges including reporting and monitoring requirements, and, and related regulatory 

issues. EPA also consulted with the Department of Defense, environmental groups, and dental 

amalgam separator manufacturers.

d. Effects of Less Frequent Collection

Dental offices are not currently required to report the characteristics of their discharges to 

Control Authorities. Beyond the initial reporting requirements that would be required in 40 CFR 

Part 403, the proposed rule would require dental offices to submit annual certifications of 

compliance. Data submission less frequent than annually would prevent the permitting

authorities from carrying out their duties to enforce the requirements of the proposed rule. 

e. General Guidelines

The information collection requirements of the rule are in accordance with the Paperwork 

Reduction Act guidelines in 5 CFR 1320.5(d)(2).
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f. Confidentiality

Reports submitted to the Control Authority may contain confidential business 

information. However, 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.

g. Sensitive Questions

The rule does not require respondents to divulge information of a sensitive nature, such 

as private or personal information.

4. The Respondents and the Information Requested

a. Respondent NAICS Codes

Dental Offices: The respondents affected by this information collection request are dental 

dischargers. The North American Industry Classification System (NAICS) identification number 

applicable to respondents is: 621210: Offices of Dentists. The U.S. Census Bureau describes this 

U.S. industry as the independent practice of general or specialized dentistry, or dental surgery.

These practitioners operate individual or group practices in their own offices or in the offices of 

others, such as hospitals or HMO medical centers. They can provide either comprehensive 

preventive, cosmetic, or emergency care, or specialize in a single field of dentistry. Dentistry 

may also be performed at larger institutional dental service facilities (e.g., clinics or dental 

schools). EPA is not proposing to include wastewater discharges from dental facilities where the 

practice of dentistry consists exclusively of one or more of the following dental specialties: oral 

pathology, oral and maxillofacial radiology, oral and maxillofacial surgery, orthodontics, 

periodontics, or prosthodontics.

Control authorities: Control authorities have regulatory oversight for pollutant discharges 

to POTWs The “Control Authority” refers to the POTW if the POTW has an approved 

pretreatment program, or the Approval Authority if it has not been approved, which may be the 

State or EPA. By establishing categorical pretreatment standards for the dental category, control 

authorities would be subject to certain additional oversight requirements in 40 CFR Part 403. 

Because of the large number of dental offices, EPA recognizes that the current regulatory 

framework in 40 CFR Part 403 would need to be adjusted for the effective implementation and 

enforcement of these pretreatment requirements on the dental industry. As such, EPA is also 

proposing changes to 40 CFR Part 403 to streamline oversight requirements for control 

authorities. 
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b. Information Requested

i. Data Items, Including Record Keeping Requirements

The proposed rule would require all affected dentists 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 and the use of Best Management Practices. In order to simplify 

compliance with, and enforcement of the numeric reduction requirements and to reduce costs, 

the proposed rule would allow dental offices to demonstrate compliance by certifying annually 

that they have installed and are operating and maintaining compliant amalgam separators and 

performing the specified best management practices. Similarly, the proposed rule would 

simplify the information that dental offices would be required to submit as required in 40 CFR 

Part 403 (including eliminating discharge monitoring) from the one time initial reporting 

requirements (i.e., baseline monitoring report and 90 day compliance report). The proposed rule 

would exempt dental dischargers that do not place or remove amalgam following a one-time 

certification to that effect. 

ii. Respondent Activities

The dental office would complete a baseline monitoring report, a one-time compliance 

report and an annual compliance certification. Dental offices that do not place or remove 

amalgam would only complete a one-time certification. The proposal would require that a 

Control Authority evaluate, at least once per year, whether a dental discharger meets the criteria 

for reduced oversight requirements. EPA anticipates that this evaluation will primarily involve 

the Control Authority’s verification that the required certifications have been submitted by the 

dental office documenting compliance

5. The Information Collected – Agency Activities, Collection Methodology, and 

Information Management

a. Agency Activities

EPA is responsible for overseeing the implementation of the rule. As explained above, 

implementation of reporting requirements would rely extensively on POTWs (if the POTW has 

an approved pretreatment program), or the Approval Authority if it has not been approved, which 

may be the State or EPA. Where the POTW does not have an approved pretreatment program 

and EPA is the Approval Authority, EPA performs the same activities as those outlined for

Control Authorities in Section 4.

b. Collection Methodology and Management

A dental discharger would submit its annual report in a manner specified by the Control 

Authority. The proposal would require that a Control Authority evaluate, initially, and at least 

once per year, whether the dentist meets the criteria for reduced oversight. EPA anticipates that 

this evaluation will primarily involve the Control Authority’s verification that the certification 

has been submitted by the dental office.
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c. Small Entity Flexibility

The vast majority of the dental industry are small businesses as defined by the Small 

Business Administration. As described above, the proposed rule would enable these small 

businesses to minimize compliance reporting requirements. 

d. Collection Schedule

As explained in Section 4.b.i, dental offices would be required to submit two one-time 

reports: the Baseline report would be due 180 days after the effective date of the rule and the 90 

Day Compliance Report would be due within 90 days of the final compliance date of the rule. 

Periodic Monitoring Reports would be due once a year or as directed by the Control Authority. 

Those dental offices that do not place or remove amalgam would submit a one-time certification 

in lieu of any other reporting requirements. 

6. Estimating the Burden and Cost of the Collection

a. Estimating Respondent Burden

Dentists: EPA assumed all affected dental offices would elect to comply with today’s 

proposal through the proposed alternative in 40 CFR Part 441 rather than the otherwise 

applicable requirements for categorical dischargers in currently specified in 40 CFR Part 403. 

EPA estimates 109, 972 dental offices would be subject to today’s proposed rule. As explained 

above, dental offices would complete a one-time baseline monitoring report, a one-time 

compliance report and an annual compliance certification. EPA estimates that the completion of 

each of these reports would take 76 minutes, 51 minutes, and 49 minutes, respectively. 

Therefore, dental offices would require approximately 2 hours of labor associated with one time 

reporting and approximately one hour per year associated with the annual reporting requirements 

in this ICR. Dental offices that do not place or remove amalgam would only complete a onetime certification and EPA estimates this would take the same amount of time as the baseline 

monitoring report (76 minutes). As explained previously, EPA notes this is a reduction in 

burden that dental offices would otherwise experience under the existing reporting requirements 

that would apply in 40 CFR Part 403.

For those dental offices that do not place or remove amalgam, EPA estimated a total 

one-time labor of 16,600 hours. For the remainder, EPA estimates total one-time labor hours 

205,000 and, thereafter, annual total labor hours of 79,100. See Table 1. Also see DCN 

DA000146.

Control Authorities: The costs to Control Authorities for review of the reports required 

by the proposed rule are significantly reduced from the existing regulatory scheme. As explained 

above, the current regulations (40 CFR Part 403) would require certain minimum oversight of 

dental dischargers by Control Authorities The required oversight includes, but is not limited to, 

receipt and analysis of reports and other notices submitted by dischargers, annual inspection and 

effluent sampling, and permit issuance (or its equivalent). The proposal would change such 

requirements for oversight of dental dischargers in 40 CFR Part 403. The proposal would require 
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that a Control Authority evaluate, at least once per year, whether a dental discharger meets the 

criteria for reduced oversight requirements. EPA anticipates that this evaluation will primarily 

involve the Control Authority’s verification that the required certifications have been submitted 

by the dental office documenting compliance. A Control Authority would only be required to 

perform the more detailed oversight requirements in the existing regulatory scheme in the event 

that a dental discharger, following notification and a reasonable amount of time to demonstrate 

compliance, failed to comply with the proposed regulation. 

As described above, the entity serving the role as the Control Authority varies. For 

purposes of this burden estimate, EPA estimates 36 States and 1,600 POTWs may serve as 

Control Authorities for Dental Dischargers. For purposes of this ICR, EPA assumed almost all 

Control Authorities would elect to comply with the proposed reduced oversight requirements for 

dental dischargers. Therefore, EPA assumed 1% of Control Authorities would need to conduct 

inspections/enforcement activities.

EPA estimated one-time recordkeeping burden associated with the one-time reports as 

well as annual recordkeeping and reporting burden. EPA also included burden for 1% of Control 

Authorities to perform inspection/enforcement activities. EPA estimates total one-time total 

labor of 1,064 hours and recurring total annual labor of 15,159 hours. For details on how EPA 

estimated each of the components, see DCN DA000147. Also see Table 2.

b. Estimating Respondent Costs

i. Estimating Labor Costs

Dentists: EPA estimated dental office labor costs for the specific activities related to the 

proposed reporting requirements of the rule. EPA based the labor costs for the proposed 

reporting requirements on average labor costs as reported for dental assistants from the Bureau of 

Labor Statistics in May, 2011 ($16.41/hour). EPA used the estimated hours required to respond 

to the requirements of the proposed rule and multiplied these costs by this labor rate. For those 

dental offices that do not place or remove amalgam, EPA estimated a one-time labor cost of 

$272,000. For the remainder, EPA estimates total one-time labor costs of $3,640,000 and, 

thereafter, annual total labor costs of $1,300,000. See Table 1. 

Control Authorities: EPA estimated Control Authority labor costs for the specific

activities related to oversight requirements. EPA based the labor costs for Control Authorities on 

average labor costs as reported for Control Authorities in Effluent Limitation Guidelines and 

Standards for the Metal Products and Machinery Category. These costs reflect $1999. EPA took 

the $1999 labor rate ($/hour) and using the Employment Cost Index for State and Local 

Government Public Administration converted to $2010 ($55.18/hour). EPA used the estimated 

hours required to respond to the requirements of the proposed rule and multiplied these costs by 

this labor rate. EPA estimated that control authorities will incur total one-time recordkeeping 

costs of $58,700 and total recurring annual administrative costs of $836,400. See Table 2.
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Table 1. Estimated Dental Office Burden and Labor Costs for One-Time Reports 

and Annual Certification 

Activity

Estimated 

Burden

Hours Per 

Office

Estimated 

Cost 

Burden 

Per Officea

Number of 

Dental 

Offices

Conducting 

Activity

Total 

Hours Total Cost

One Time Reports

Certify No Use of Amalgam 1.267 $21.5 13,102 16,600 $272,000

Baseline Monitoring Report 1.267 $21.5 96,870 123, 000 $2,010,000

90 Day Compliance Report 0.85 $13.9 96,870 82,300 $1,350,000

Total for One Time Reporting-Year 1 222,000 $3,640,000

Annual Certification- Year 1 0.82 $13.4 96,870 79,100 $1,300,000

Annual Certification- Year 2 0.82 $13.4 96,870 79,100 $1,300,000

Annual Certification- Year 3 0.82 $13.4 96,870 79,100 $1,300,000

Annual Average 153,000 $2,510,000

a – Labor rate of $16.41 per hour for a dental assistant based from Bureau of Labor Statistics (May, 2011).

Table 2: Estimated Control Authority Burden and Labor Costs for 

One-Time Reports and Annual Certification

Activity

Total 

Estimated 

Burden

Hours

Total 

Estimated 

Cost 

Burden 

Total One-Time Burden for Control 

Authority 1,064 $58,700

Total Annual Burden for Control Authority 15,159 $836,400

Total Costs in Year 1 16,2231$895,200

Total Costs in Year 2 15,159 $836,400

Total Costs in Year 3 15,159 $836,400 

Total Average Annual Cost over 3-year 

period 15,514 $856,0001

1 May not add due to rounding

 

1 This is the sum of the total on-time burden and the burden for the first year of the annual certification.
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ii. Estimating Capital and Operations and Maintenance (O&M) Costs

Because EPA is not requiring respondents (dental offices or Control Authorities) to 

purchase any nonexpendable goods, including equipment or machinery, to perform reporting, the 

Agency does not expect capital costs to result from the reporting requirements. Operation and 

maintenance costs include only printing and postage for each of the one-time reports and the 

annual certification statements that would be submitted by dental offices. Because the 

reports/certifications will be a page or two and because dental offices print routinely, EPA 

assumed this cost per dental office would be negligible. EPA estimated postage costs applying 

the current United States Post Office first class postage rate of $0.49 for each one-time 

report/certification. EPA applied these rates to the respondents in Table 1 for a total one-time 

postage cost of $101,000 and a total annual postage cost for this ICR of $47,500. The total 

average O&M cost is $81,000. 

iii. Annualizing Capital Costs

There are no capital costs associated with any of the reporting, as described above.

c. Estimating Agency Burden and Costs

As explained above, where a POTW does not have an approved pretreatment program, 

EPA (Regions) may serve as the Approval Authority. Where EPA is the Approval Authority, 

EPA will incur costs and burdens similar to those incurred Control Authorities described above.

EPA estimates total one-time total labor of 200 hours and recurring total annual labor of 2,200 

hours. The total annual average labor hours is 2300 hours. In a similar manner, EPA estimated 

that it would incur total one-time recordkeeping costs of $12,000 and total recurring annual 

administrative costs of $124,000. The total annual average is $128,000. For details on how EPA 

estimated Agency burden and costs, see DCN 000147.

d. Estimating the Respondent Universe and Total Burden Costs

Dentists: The estimated dental office universe for any reporting is for compliance 

determination reporting is approximately 110,000 dental offices. Some offices would be required 

to provide one-time reports only while others would be required to provide one time reports and 

annual certification. EPA estimates the total one-time labor hours associated with this ICR to 

dental offices to be 222,000 and total annual labor hours to be 79,100 hours for a total annual 

average of 153,000 hours. Similarly, EPA estimates the total one-time labor costs to dental 

offices to be $3,640,000 and total annual labor costs to be $1,300,000 for a total annual average 

of $2,510,000. See Table 1. In addition, EPA estimated respondents would incur O&M in the 

form of postage. The total annual average postage is $81,000. 

Control Authorities: For purposes of this ICR, EPA estimated the non-EPA Control 

Authority universe to be 36 States and 1,600 POTWs. EPA estimates total one-time total labor 

of 1,100 hours and recurring total annual labor of 15,200 hours for a total annual average of 

15,500 hours. Similarly, EPA estimates that control authorities will incur total one-time 

recordkeeping costs of $58,700 and total recurring annual administrative costs of $836,000 for a 

total annual average of $856,000. See Table 2.
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e. Bottom Line Burden Hours and Cost Tables

i. Respondent and Agency Burden Hours and Costs

Table 3. Summary of Total Burden and Costs for Respondents (Dentists) 

and Control Authorities

Respondents

Total Annual Average 

Burden

(Hours)

Total Annual Average 

Costs

Dental Offices 110,000 153,000 $2,510,000

Control Authority

(POTWs and States)

1636 15,514 $856,000

TOTAL 168,5001$3,370,0001

1 May not add due to rounding

Table 4. Summary of Total Burden and Costs for Agency (EPA)

Respondents

Total Annual Average 

Burden

(Hours)

Total Annual Average 

Costs

EPA 9 2,300 $128,000

TOTAL 2,300 $128,000

ii. Variations in the Annual Bottom Line

The burden to Control Authorities would increase for dental dischargers that do not 

submit the required reports in a timely manner.

f. Reasons for Change in Burden

Not applicable, because this request does not renew or modify an existing ICR.

g. Burden Statement

The information collection requirements in this rule have been submitted for approval to 

OMB under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. An Information Collection 

Request (ICR) document has been prepared by EPA and has been assigned EPA 2514. The 

information collection requirements are not enforceable until OMB approves them. EPA 

estimates it would take a total annual average of 153,000 hours and $2.5 million for affected 

dental offices to collect and report the information required for certification in the proposed rule. 

This estimate includes effort associated with completing the baseline monitoring report, a onetime compliance report and an annual compliance certification for each year of this three year 
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ICR. This estimate is based on average labor rates from the Bureau of Labor Statistics for the 

dental office personnel involved in collecting and reporting the information required. EPA 

estimates it would take a total annual average of 15,514 hours and $856,000 for control 

authorities to review the information submitted by dentists that certify they meet the 

requirements in the proposed rule. EPA estimates that there would be no start-up or capital costs 

associated with the information described above. Burden is defined at 5 CFR 1320(b).

An agency may not conduct or sponsor, and a person is not required to respond to, a 

collection of information unless it displays a currently valid OMB control number. The OMB 

control numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9. When this ICR is 

approved by OMB, the Agency will publish a technical amendment to 40 CFR part 9 in the 

Federal Register to display the OMB control number for the approved information collection 

requirements contained in this final rule.