HomeMy Public PortalAboutOne-Time Compliance Report for Dental DischargersJune 2018
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ONE-TIME COMPLIANCE REPORT FOR DENTAL DISCHARGERS
40 CFR 441.50
Effluent Limitations Guidelines and Standards for the Dental Office Category
This form 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.
See Instructions at the end of this form.
1.0. General Information
1.1. Name of Facility
1.2. Physical Address of Dental Facility
City: State: Zip:
1.3. Name of Wastewater Utility:
Billing Address:
1.4. Mailing Address (if different than physical address)
City: State: Zip:
1.5. Facility Contact
Phone: Email:
1.6. Names of Owner(s):
Names of Operator(s) if different from
Owner(s):
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2.0. Applicability: Please Select One of the Following
☐ 2.1. 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.
☐ 2.2. 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
(See 40 CFR Part 441, limited emergency circumstances is from once a quarter to 96 times a year).
Complete section E only.
(Also, select if applicable) Transfer of Ownership (§ 441.50(a)(4))
☐ 2.3. 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.
1.0. Description of Facility
YES
☐
NO
☐
1.1. The facility discharged amalgam process wastewater prior to July 14th, 2017, under any
ownership. Used to distinguish dental dischargers that are considered Existing Sources
under the rule. Existing sources commence discharge to POTW prior to July, 14 2017. New
Sources means a dental discharger whose first discharge to a POTW occurs after July 14,
2017. New Sources must comply with rule no later than 90 days from the introduction of
wastewater to the Publicly Owned Treatment Works (POTW).
1.2. Total number of chairs:
1.3. Total number of chairs at which amalgam may be present in the
resulting wastewater (i.e., chairs where amalgam may be placed or
removed):
1.4. Description of any amalgam separator(s) or equivalent device(s) currently operated:
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Section B
1.0. Description of Amalgam Separator or Equivalent Device
☐ 1.1. 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:
☐ 1.2. 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
☐ 1.3. 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.
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Section C
1.0. Design, Operation and Maintenance of Amalgam Separator/Equivalent Device
☐ YES 1.1. 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 or the separator or equivalent devices in accordance with § 441.30 or § 441.40.
☐ YES
1.2. Name of third-party
service provider (e.g.
Company Name) that
maintains the amalgam
separator or equivalent
device (if applicable):
☐ NO 1.3. 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
1.0. Best Management Practices (BMP) Certifications
☐ 1.1. 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).
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Section E
1.0. Certification Statement
1.1. 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.”
1.2. 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.
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Instructions:
1.0. General Information
1.1 Self-explanatory.
1.2 Self-explanatory.
1.3 Include the name of the wastewater utility to which your facility discharges wastewater. This may not
be the City in which you facility resides. If your billing information does not provide that information
please contact your City’s public works department.
Billing address of the wastewater utility may indicate the wastewater utility to which your facility
discharges wastewater.
1.4 Mailing address if it is different than physical address of the facility.
1.5 Contact person who is responsible for the dental operation at the facility.
1.6 The owners may proprietors or partners that may not the operators of the facility. Operators are
those that are responsible for the day to day operations of the facility.
2.0. Applicability
2.1., 2.2. Select either one of these categories based on the description provided. For 2.1, complete sections
A, B, C, D, and E. For 1.2, complete section E only.
2.3. Transfer of ownership should check this box.
Section A.
1.0 Description of Facility
1.1 That is trying to ascertain whether the discharge is an existing discharge prior to the effective date of
the rule on July 14, 2017 or a new discharge under the rule. Definition: New Sources means a dental
discharger whose first discharge to a POTW occurs after July 14, 2017.
1.2 The 40 CFR 441 regulations require description of the Total number of dental chairs in the facility.
1.3 The 40 CFR 441 regulations require description of the Total number of dental chairs in the facility at
which dental amalgam may be present in wastewater.
1.4 The 40 CFR 441 regulations require description of any existing amalgam separator(s) or equivalent
devices currently in operation. The final rule includes a provision at 441.3(a)(2) that allows the
performance standard of the final rule can be met with the use of an amalgam-removing technology
other than an amalgam separator (equivalent device). EPA included this provision to allow use of
equivalent devices that achieve comparable removals of pollutants from dental discharges as amalgam
separators but that may not fall under the amalgam separator classification. The equivalent device is
required to meet the same requirements and removal efficiencies, as specified in § 441.30(a)(1-2) or §
441.40.
Section B
1.0 Description of Amalgam Separator or Equivalent Device
1.1. This is asking for the number of chairs that have amalgam separators that meet the rule standards i.e.,
one or more ISO 11143 (or ANSI/ADA 108-2009).
1.2. This is asking for the number of chairs that have amalgam separators prior to the effective date of the
rule that do not meet the standards.
Provide the Make, Model and Years of installation for those that meet the standards and below
provide the Make Model and Years of installation for those do not.
1.3. Provide the Make, Model and Years of installation for those equivalent devices and its removal
efficiency.
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Section C
1.0. Design, Operation and Maintenance of Amalgam Separator/Equivalent Device
1.1. Self-explanatory. This will correspond with the signature.
1.2. Check, Yes, if the facility has a third-party service provider (under contract), or otherwise the company
from which you purchased the separator, to ensure proper operation and maintenance in accordance
with § 441.30 or § 441.40.
1.3. Check No if no service provider then provide the practices that are used at the facility to ensure
proper maintenance in accordance with § 441.30 or § 441.40.
Section D
1.0 Best Management Practices (BMP) Certifications
Must certify that the facility is implementing the required BMPs by regulation.
Section E
1.0 Certification Statement
The one-time compliance report must be signed and certified by a responsible corporate officer, or a
duly authorized representative in accordance with 40 CFR 403.12(I).
Please provide an email contact.
Mail the signed One-Time Compliance Report to:
Industrial Pretreatment Program
Metropolitan St. Louis Sewer District
Division of Environmental Compliance
10 East Grand Ave.
St. Louis, MO 63147
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PART 441—DENTAL OFFICE POINT SOURCE CATEGORY
441.10
Applicability.
441.20
General definitions.
441.30
Pretreatment standards for existing
sources (PSES).
441.40
Pretreatment standards for new sources
(PSNS).
441.50
Reporting and recordkeeping
requirements.
§ 441.10 Applicability.
(a) Except as provided in paragraphs (c), (d),
and (e) of this section, this part applies to
dental dischargers.
(b) Unless otherwise designated by the
Control Authority, dental dischargers subject
to this part are not Significant Industrial
Users as defined in 40 CFR part 403, and are
not “Categorical Industrial Users” or
“industrial users subject to categorical
pretreatment standards” as those terms and
variations are used in 40 CFR part 403, as a
result of applicability of this rule.
(c) This part does not apply to dental
dischargers that exclusively practice one or
more of the following dental specialties: Oral
pathology, oral and maxillofacial radiology,
oral and maxillofacial surgery, orthodontics,
periodontics, or prosthodontics.
(d) This part does not apply to wastewater
discharges from a mobile unit operated by a
dental discharger.
(e) This part does not apply to dental
dischargers that do not discharge any
amalgam process wastewater to a POTW,
such as dental dischargers that collect all
dental amalgam process wastewater for
transfer to a Centralized Waste Treatment
facility as defined in 40 CFR part 437.
(f) Dental Dischargers that do not place
dental amalgam, and do not remove amalgam
except in limited emergency or unplanned,
unanticipated circumstances, and that certify
such to the Control Authority as required in
§ 441.50 are exempt from any further
requirements of this part.
§ 441.20 General definitions.
For purposes of this part:
(a) Amalgam process wastewater means any
wastewater generated and discharged by a
dental discharger through the practice of
dentistry that may contain dental amalgam.
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(b) Amalgam separator means a collection
device designed to capture and remove dental
amalgam from the amalgam process
wastewater of a dental facility.
(c) Control Authority is defined in 40 CFR
403.3(f).
(d) Dental amalgam means an alloy of
elemental mercury and other metal(s) that is
used in the practice of dentistry.
(e) Dental Discharger means a facility where
the practice of dentistry is performed,
including, but not limited to, institutions,
permanent or temporary offices, clinics, home
offices, and facilities owned and operated by
Federal, state or local governments, that
discharges wastewater to a publicly owned
treatment works (POTW).
(f) Duly Authorized Representative is defined
in 40 CFR 403.12(l)(3).
(g) Existing Sources means a dental
discharger that is not a new source.
(h) Mobile unit means a specialized mobile
self-contained van, trailer, or equipment used
in providing dentistry services at multiple
locations.
(i) New Sources means a dental discharger
whose first discharge to a POTW occurs after
July 14, 2017.
(j) Publicly Owned Treatment Works is
defined in 40 CFR 403.3(q).
§ 441.30 Pretreatment standards for existing
sources (PSES).
No later than July 14, 2020, any existing
source subject to this part must achieve the
following pretreatment standards:
(a) Removal of dental amalgam solids from
all amalgam process wastewater by one of the
following methods:
(1) Installation, operation, and maintenance
of one or more amalgam separators that meet
the following requirements:
(i) Compliant with either the American
National Standards Institute (ANSI)
American National Standard/American
Dental Association (ADA) Specification 108
for Amalgam Separators (2009) with
Technical Addendum (2011) or the
International Organization for
Standardization (ISO) 11143 Standard (2008)
or subsequent versions so long as that version
requires amalgam separators to achieve at
least a 95% removal efficiency. Compliance
must be assessed by an accredited testing
laboratory under ANSI's accreditation
program for product certification or a testing
laboratory that is a signatory to the
International Laboratory Accreditation
Cooperation's Mutual Recognition
Arrangement. The testing laboratory's scope
of accreditation must include ANSI/ADA
108-2009 or ISO 11143.
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(ii) The amalgam separator(s) must be sized
to accommodate the maximum discharge rate
of amalgam process wastewater.
(iii) A dental discharger subject to this part
that operates an amalgam separator that was
installed at a dental facility prior to June 14,
2017, satisfies the requirements of paragraphs
(a)(1)(i) and (ii) of this section until the
existing separator is replaced as described in
paragraph (a)(1)(v) of this section or until
June 14, 2017, whichever is sooner.
(iv) The amalgam separator(s) must be
inspected in accordance with the
manufacturer's operating manual to ensure
proper operation and maintenance of the
separator(s) and to confirm that all amalgam
process wastewater is flowing through the
amalgam retaining portion of the amalgam
separator(s).
(v) In the event that an amalgam separator is
not functioning properly, the amalgam
separator must be repaired consistent with
manufacturer instructions or replaced with a
unit that meets the requirements of
paragraphs (a)(i) and (ii) of this section as
soon as possible, but no later than 10 business
days after the malfunction is discovered by
the dental discharger, or an agent or
representative of the dental discharger.
(vi) The amalgam retaining units must be
replaced in accordance with the
manufacturer's schedule as specified in the
manufacturer's operating manual or when the
amalgam retaining unit has reached the
maximum level, as specified by the
manufacturer in the operating manual, at
which the amalgam separator can perform to
the specified efficiency, whichever comes
first.
(2) Installation, operation, and maintenance
of one or more amalgam removal device(s)
other than an amalgam separator. The
amalgam removal device must meet the
following requirements:
(i) Removal efficiency of at least 95 percent
of the mass of solids from all amalgam
process wastewater. The removal efficiency
must be calculated in grams recorded to three
decimal places, on a dry weight basis. The
removal efficiency must be demonstrated at
the maximum water flow rate through the
device as established by the device
manufacturer's instructions for use.
(ii) The removal efficiency must be
determined using the average performance of
three samples. The removal efficiency must
be demonstrated using a test sample of dental
amalgam that meets the following particle
size distribution specifications: 60 percent by
mass of particles that pass through a 3150 µm
sieve but which do not pass through a 500 µm
sieve, 10 percent by mass of particles that
pass through a 500 µm sieve but which do not
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pass through a 100 µm sieve, and 30 percent
by mass of particles that pass through a 100
µm sieve. Each of these three specified
particle size distributions must contain a
representative distribution of particle sizes.
(iii) The device(s) must be sized to
accommodate the maximum discharge rate of
amalgam process wastewater.
(iv) The devices(s) must be accompanied by
the manufacturer's manual providing
instructions for use including the frequency
for inspection and collecting container
replacement such that the unit is replaced
once it has reached the maximum filling level
at which the device can perform to the
specified efficiency.
(v) The device(s) must be inspected in
accordance with the manufacturer's operation
manual to ensure proper operation and
maintenance, including confirmation that
amalgam process wastewater is flowing
through the amalgam separating portion of
the device(s).
(vi) In the event that a device is not
functioning properly, it must be repaired
consistent with manufacturer instructions or
replaced with a unit that meets the
requirements of paragraphs (a)(2)(i) through
(iii) of this section as soon as possible, but no
later than 10 business days after the
malfunction is discovered by the dental
discharger, or an agent or representative of
the dental discharger.
(vii) The amalgam retaining unit(s) of the
device(s) must be replaced as specified in the
manufacturer's operating manual, or when the
collecting container has reached the
maximum filling level, as specified by the
manufacturer in the operating manual, at
which the amalgam separator can perform to
the specified efficiency, whichever comes
first.
(viii) The demonstration of the device(s)
under paragraphs (a)(2)(i) through (iii) of this
section must be documented in the One-Time
Compliance Report.
(b) Implementation of the following best
management practices (BMPs):
(1) 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 POTW.
(2) Dental unit water lines, chair-side traps,
and vacuum lines that discharge amalgam
process wastewater to a POTW 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.
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(c) All material is available for inspection at
EPA's Water Docket, EPA West, 1301
Constitution Avenue NW., Room 3334,
Washington, DC 20004, Telephone: 202-566-
2426, and is available from the sources listed
below.
(1) The following standards are available
from the American Dental Association
(ADA), 211 East Chicago Ave., Chicago IL
60611-2678, Telephone 312-440-
2500, http://www.ada.org.
(i) ANSI/ADA Specification No. 108:2009,
American National Standard/American
Dental Association Specification No. 108
Amalgam Separators. February 2009.
(ii) ANSI/ADA Specification No. 108:2009
Addendum, American National
Standard/American Dental Association
Specification No. 108 Amalgam Separators,
Addendum. November 2011.
(2) The following standards are available
from the American National Standards
Institute (ANSI), 25 West 43rd Street, 4th
Floor, New York, NY 10036, Telephone 212-
642-4900, http://webstore.ansi.org.
(i) International Standard ISO 11143:2008,
Dentistry—Amalgam Separators. Second
edition, July 1, 2008.
(ii) [Reserved]
§ 441.40 Pretreatment standards for new
sources (PSNS).
As of July 14, 2017, any new source subject
to this part must comply with the
requirements of § 441.30(a) and (b) and the
reporting and recordkeeping requirements of
§ 441.50.
§ 441.50 Reporting and recordkeeping
requirements.
(a) Dental Dischargers subject to this part
must comply with the following reporting
requirements in lieu of the otherwise
applicable requirements in 40 CFR 403.12(b),
(d), (e), and (g).
(1) One-Time Compliance Report
deadlines. For existing sources, a One-Time
Compliance Report must be submitted to the
Control Authority no later than October 12,
2020, or 90 days after a transfer of ownership.
For new sources, a One-Time Compliance
Report must be submitted to the Control
Authority no later than 90 days following the
introduction of wastewater into a POTW.
(2) Signature and certification. The One-
Time Compliance Report must be signed and
certified by a responsible corporate officer, a
general partner or proprietor if the dental
discharger is a partnership or sole
proprietorship, or a duly authorized
representative in accordance with the
requirements of 40 CFR 403.12(l).
(3) Contents. (i) The One-Time Compliance
Report for dental dischargers subject to this
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part that do not place or remove dental
amalgam as described at § 441.10(f) must
include the: facility name, physical address,
mailing address, contact information, name of
the operator(s) and owner(s); and a
certification statement that the dental
discharger does not place dental amalgam and
does not remove amalgam except in limited
circumstances.
(ii) The One-Time Compliance Report for
dental dischargers subject to the standards of
this part must include:
(A) The facility name, physical address,
mailing address, and contact information.
(B) Name(s) of the operator(s) and owner(s).
(C) A description of the operation at the
dental facility including: The total number of
chairs, the total number of chairs at which
dental amalgam may be present in the
resulting wastewater, and a description of any
existing amalgam separator(s) or equivalent
device(s) currently operated to include, at a
minimum, the make, model, year of
installation.
(D) Certification that the amalgam
separator(s) or equivalent device is designed
and will be operated and maintained to meet
the requirements specified in § 441.30 or
§ 441.40.
(E) Certification that the dental discharger is
implementing BMPs specified in § 441.30(b)
or § 441.40(b) and will continue to do so.
(F) The name of the third-party service
provider that maintains the amalgam
separator(s) or equivalent device(s) operated
at the dental office, if applicable. Otherwise, a
brief description of the practices employed by
the facility to ensure proper operation and
maintenance in accordance with § 441.30 or
§ 441.40.
(4) Transfer of ownership notification. If a
dental discharger transfers ownership of the
facility, the new owner must submit a new
One-Time Compliance Report to the Control
Authority no later than 90 days after the
transfer.
(5) Retention period. As long as a Dental
Discharger subject to this part is in operation,
or until ownership is transferred, the Dental
Discharger or an agent or representative of
the dental discharger must maintain the One-
Time Compliance Report required at
paragraph (a) of this section and make it
available for inspection in either physical or
electronic form.
(b) Dental Dischargers or an agent or
representative of the dental discharger must
maintain and make available for inspection in
either physical or electronic form, for a
minimum of three years:
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(1) Documentation of the date, person(s)
conducting the inspection, and results of each
inspection of the amalgam separator(s) or
equivalent device(s), and a summary of
follow-up actions, if needed.
(2) Documentation of amalgam retaining
container or equivalent container replacement
(including the date, as applicable).
(3) Documentation of all dates that collected
dental amalgam is picked up or shipped for
proper disposal in accordance with 40 CFR
261.5(g)(3), and the name of the permitted or
licensed treatment, storage or disposal facility
receiving the amalgam retaining containers.
(4) Documentation of any repair or
replacement of an amalgam separator or
equivalent device, including the date,
person(s) making the repair or replacement,
and a description of the repair or replacement
(including make and model).
(5) Dischargers or an agent or representative
of the dental discharger must maintain and
make available for inspection in either
physical or electronic form the manufacturers
operating manual for the current device.