Ohio Administrative Code
Title 3745 - Ohio Environmental Protection Agency
Chapter 3745-89 - Laboratory Approval
Section 3745-89-12 - Alternate acceptance of laboratory certification
Universal Citation: OH Admin Code 3745-89-12
Current through all regulations passed and filed through September 16, 2024
(A) Acceptance of certification. In lieu of complying with the requirements of rule 3745-89-03 of the Administrative Code, laboratories may apply for acceptance of certification to perform analyses to determine compliance with Chapters 3745-81 and 3745-82, and rules 3745-91-06 and 3745-9-09, and as specified by paragraph (B) of rule 3745-83-01 of the Administrative Code by meeting the following requirements:
(1)
The laboratory is
certified by the United States environmental protection agency (USEPA), the
national environmental laboratory accreditation program (NELAP), or by another
environmental laboratory accreditation program acceptable to the director to
perform required analyses for those Fields of Accreditation in which the
laboratory is requesting acceptance of certification pursuant to this rule,
with the exception of those analytes required in Chapter 3745-90 of the
Administrative Code. The Field of Accreditation shall be for drinking
water.
(2)
The laboratory submits an application on a form
acceptable to the director.
(3)
The laboratory
submits a copy of the most recent certificate and Field of Accreditation issued
by an acceptable accrediting body for the USEPA approved drinking water methods
which acceptance is sought.
(4)
The laboratory
submits evaluations of the two most recent Proficiency Test (PT) sample
studies. A provider of PT samples must be accredited by a Proficiency Testing
Provider Accreditor that meets the National Environmental Laboratory
Accreditation Conference requirements.
(5)
The laboratory
submits evaluations of any PT sample studies within the previous five years
that have resulted in an evaluation of "Unacceptable" and the subsequent
make-up PT sample evaluation.
(6)
The Laboratory
submits reports from the most recent on-site survey by the accrediting body
issuing the certification. The on-site inspection shall be completed by a
program acceptable to the Ohio EPA.
(7)
The laboratory
shall submit all correspondence, documents or other communications between the
laboratory and the accrediting body which may affect the laboratory's
accreditation within thirty days. Failure to submit these articles may result
in loss of Ohio EPA acceptance of certification.
(8)
For out of state
laboratories, a certification that one of the conditions listed in paragraph
(D) of rule
3745-89-02
of the Administrative Code exists at the time of application. Any acceptance of
certification for an out of state laboratory shall only remain effective so
long as one of the conditions listed in paragraph (D) of rule
3745-89-02
of the Administrative Code continues to exist.
(B) Renewal of acceptance of certification. For acceptance of certifications issued in accordance with paragraph (A) of this rule, the director may renew an acceptance of certification in accordance with paragraph (D) of this rule upon the laboratory's successful completion of the following:
(1)
The laboratory
shall maintain a valid and unexpired laboratory certification issued by an
accreditation program approved under paragraph (A)(1) of this rule for the
analyses for which renewal is sought.
(2)
The laboratory
shall submit to the director for a completed application for renewal, including
the information required under paragraph (A) of this rule, with the exception
of paragraph (A)(4), no sooner than one hundred twenty days and no later than
thirty days prior to the expiration of the currently valid certification. When
applications are submitted in accordance with this rule and deemed complete,
the laboratory acceptance of certification will be extended until the earlier
of three years from the date of renewal or the expiration of certification
issued by an accreditation program approved under paragraph (A)(1) of this
rule.
(3)
The laboratory submits evaluations of the most recent
Proficiency Test (PT) sample studies. A provider of PT samples must be
accredited by a Proficiency Testing Provider Accreditor that meets the National
Environmental Laboratory Accreditation Conference requirements.
(C) Maintenance of acceptance of certification. To maintain an acceptance of certification a laboratory shall comply with the requirements of paragraphs (A)(11), (A)(12) and (A)(14) of rule 3745-89-05 and rule 3745-89-08 of the Administrative Code.
(D) Director's actions.
(1)
The director may issue or renew an acceptance of certification provided the
laboratory has met the requirements for acceptance as described in this
rule.
(2)
The period and provisions of each acceptance of
certification are summarized on a laboratory acceptance, which is issued to the
laboratory as a record of the acceptance and certification
details.
(3)
The director may deny, suspend or revoke an acceptance
of certification in accordance with Chapters 3745-47 and 3745-49 of the
Administrative Code upon a finding of any of the criteria under paragraph (B)
or (C) of rule
3745-89-06
of the Administrative Code or upon a finding that the laboratory no longer
holds a valid unexpired certification from an accreditation program approved
under paragraph (A)(1) of this rule.
(4)
During the
pendency of an action to suspend or revoke an acceptance of certification, the
results of performances on a proficiency test shall not be considered by the
director in making a determination to suspend or revoke the acceptance of
certification.
(5)
The results of drinking water analyses shall not be
acceptable for determining compliance with Chapters 3745-81 or 3745-82, and
rules
3745-91-06
and
3745-9-09,
or as specified by paragraph (B) of rule
3745-83-01
of the Administrative Code, or for other analyses required by the director, if
the results are obtained in violation of rule
3745-81-27
of the Administrative Code or this chapter during the pendency of an action to
suspend or revoke an acceptance of certification.
(6)
Suspension of an
acceptance of certification shall be for a time period specified by the
director, but no less than thirty days and no more than six months, provided a
correction statement is submitted in writing to the director addressing each
individual violation within the time period specified by the director and is
acceptable to the director.
(7)
The director may
notify or require a laboratory to notify customers, within a specific period of
time, of the suspended or revoked acceptance of certification.
(8)
The laboratory
shall demonstrate in a manner acceptable to the director that violations have
been addressed to cease suspended acceptance of certifications. The
demonstration shall be in writing and may include, but not be limited to,
on-site surveys or other means as determined by the director. If the violations
are not satisfactorily addressed within the specified time period, the
acceptance of certification may remain suspended or be revoked.
(9)
Revocation or
denial of a new or renewed acceptance of certification shall remain in effect
for a time period specified by the director of not less than ninety days and
not more than one year. Laboratories shall not reapply for acceptance of
certification until the period of denial or revocation expires. After such
time, the laboratory may apply for acceptance of certification as specified in
this rule.
(10)
An action taken by the director under this rule does
not preclude the director from pursuing additional civil or criminal
enforcement. Suspension or revocation may include any or all acceptance of
certifications issued by the director under this chapter.
(E) An acceptance of certification issued under this rule remains the property of the state and shall be surrendered to the director upon revocation.
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