ORDERS:
ORDER
STATEMENT OF THE CASE
This matter is before me pursuant to Petitioner's request for a contested case hearing on
Respondent's decision to rescind for all parameters Certificate No. 26001001, issued pursuant to
Respondent's Laboratory Certification Program. After notice to the parties, a contested case
hearing was held on May 21, 1996. Petitioner did not contest that record keeping, including chain
of custody, deficiencies existed under a previous director of the laboratory. Instead, Petitioner
asked that the South Carolina Department of Health and Environmental Control (Department)
sufficiently explain the nature and regulatory basis of the violations so that the laboratory can
come into compliance. Secondly, Petitioner asked that the laboratory be granted "provisionally
certified" status until it can fully come into compliance with the standards outlined by the
Department. For the reasons set out below, the Petitioner is granted provisional certification
status and the Department is required to provide a more complete and detailed explanation of the
deficiencies Petitioner must correct in order to retain its certification for the applicable
parameters.
POSITIONS OF THE PARTIES
Petitioner does not dispute that record keeping deficiencies exist at the laboratory. Petitioner
stresses that these problems occurred while its operations were under the control of a director
who is no longer associated with the laboratory. Now that the previous director has been
replaced, Petitioner wishes to retain its certification while it remedies the record keeping problems
that remain. Instead of having its certification rescinded for all parameters, Petitioner requests
that its certification status merely be downgraded to "provisionally certified," a certification status
provided in the United States Environmental Protection Agency Manual for the Certification of
Laboratories Analyzing Drinking Water. Petitioner also argues that it has been unable to discern
the specific reasons for the actions taken by the Department. It asserts the Department has not
adequately explained how S.C. Code Regs. 61-81 (1989) has been violated and what Petitioner
must do to come into compliance with the regulation. In short, Petitioner asserts that the
deficiencies upon which the decertification is based need to be presented with greater precision.
The Department argues that Regs. 61-81 does not contemplate "provisionally certified." As a
result, it asserts that "provisionally certified" status is not available to Petitioner.
FINDINGS OF FACT
Based upon the evidence presented, I make the following findings of fact, taking into
consideration the burden on the parties to establish their respective cases by a preponderance of
the evidence and taking into account the credibility of the witnesses:
1. This Division has personal and subject matter jurisdiction.
2. Notice of the date, time, place and nature of the hearing was timely given to all parties.
3. Petitioner, Coastal Carolina University Environmental Monitoring Laboratory is certified for
the analysis of eleven trace metal contaminants monitored under the State Safe Drinking Water
Act.
4. On September 12, 1995, the Department performed an on-site evaluation of the laboratory.
Prior to the site visit, the laboratory had been operating without a director. The current director,
Kim Weaver, was hired shortly before the site visit.
5. Between September 12 and September 19, 1995, T. John Williams of the Department prepared
a report identifying deficiencies uncovered during the evaluation. Based upon the deficiencies
identified in the report, Williams recommended that decertification actions be initiated.
6. By letter dated September 19, 1995, the Department rescinded, for all parameters listed on
certificate #26001001, Petitioner's certification to perform "the affected analyses."
7. Petitioner requested a contested case hearing regarding the rescinding of its certification.
8. On January 22, 1996, an Order was issued by the Administrative Law Judge requiring
Petitioner to submit all necessary documentation to demonstrate compliance and eligibility for
certification. The Order also required the Department to issue a written decision on whether to
certify the laboratory.
9. Around March 1, 1996, Petitioner delivered the following documents to the Department to
achieve compliance with my Order:
(1) Records of the EQL, Coastal Carolina University, Sept. 1995 to Present
(2) Selected records of the EQL, from February 9 to September 1995
(3) Linear Range Determinations, Kim Weaver, September 1995
(4) IDL Studies, Kim Weaver, September 1995
(5) Quality Assurance (QA) Manual
(6) Standard Operation Procedure (SOP) Manual
(7) Forms used by EQC, appendix to the QA and SOP Manuals
(8) Letter documenting printout procedure of Varian 475 AA Spectrometer
(9) Summary of ERA Performance Evaluation Audit
(10) Copy of WP 35 Report
(11) Linear Range Determinations, (Nutrients) Brian Donahue, January 1996
10. On April 3, 1996, counsel for the Department sent a letter to Petitioner's counsel stating that
"...DHEC is unable to certify Coastal Carolina at this time." A list of the remaining deficiencies
was attached to the letter.
11. On April 8, 1996, T. John Williams issued a letter to Kim Weaver, the director of the
laboratory, in response to Petitioner's submission of the above documents. After reviewing the
materials, Williams stated that "[a]pparently, a misunderstanding still exists concerning the
purpose of the data submission and the scope of the 'certification' offered by this Office."
Williams' chief complaint regarding the data submission was that Petitioner continued to
commingle data gathered from "regulatory monitoring" with "non-regulatory testing" also
conducted by the laboratory. Williams informed Weaver that Petitioner had the time prior to the
adjudicatory hearing "to continue with the required follow-up actions" spelled out in the letter.
12. On April 19, 1996, Williams and Weaver met to discuss the contents of the April 8, 1996
letter. Weaver then issued a April 23, 1996 letter to Williams outlining nine requirements, agreed
upon during the meeting, to be satisfied in order for Petitioner to retain certification.
13. There was no response from DHEC to his letter of April 23, 1996 by May 13, 1996. Weaver
assumed his assessment of the remaining certification requirements was correct. On that date, he
sent Williams the documentation necessary to fulfill the certification requirements as outlined in
his letter of April 23.
14. On May 20, 1996, Williams issued a draft memorandum to his supervisor, R. Wayne Davis,
which provided a summary of his findings regarding Weaver's May 13 data submission.
15. On May 20, 1996, Davis issued a memorandum to Petitioner's counsel to inform him that the
Department was in the process of reviewing Weaver's May 13 data submission.
16. The Department had not, as of the date of the hearing, provided Petitioner with a response to
Weaver's submission of May 13, 1996. No evidence relating to this data submission was
presented at the hearing to determine whether the laboratory was still not complying with the
Department's requirements.
17. The Department has no process whereby it notifies laboratories of specific procedures that
must be followed in order to meet DHEC's expectations.
18. The Department admits it did not provide notice to the new director to the laboratory (Kim
Weaver) of its requirements in acceptable procedures, methodology, techniques, facilities, quality
control, records keeping, and equipment, including the changes in those requirements, as required
by Regs. 61-81 (F). The Department also did not provide copies of statutes or regulations
relating to the Safe Drinking Water Act to Petitioner.
19. The Department failed to provide Petitioner with a detailed enumeration of deficiencies
necessary to be corrected in order for the laboratory to retain its certification. Each time data was
submitted to comply with the Department's requirements, the Department found new problems.
CONCLUSIONS OF LAW
Based on the foregoing Findings of Fact, I conclude the following as a matter of law:
1. The Administrative Law Judge Division is authorized to hear this case pursuant to S.C. Code
Ann. §§44-55-40(I) (1976); 1-23-600(B) (Supp. 1995), and 1-23-310 et seq. (Supp. 1995).
2. S.C. Code Ann. §44-55-10 et seq. (1976 and Supp. 1995) comprises the State Safe Drinking
Water Act (Act). The State Primary Drinking Water Regulations, at S.C. Code Regs. 61-58 et
seq. (1992 and Supp. 1995), were promulgated pursuant to the Act. The Act and the regulations
were designed to regulate facilities who provide drinking water to the public; and to insure the
safety of the drinking water produced by those facilities. Regulation 61-58.5 provides the
maximum contaminant levels allowed in drinking water.
3. S.C. Code Ann. §44-55-40(I) (1976) authorizes the Department to "...conduct studies,
investigations, surveillance of laboratories, including certification programs, and maintenance of
any public water supply, waterworks system and water treatment facility; . . ."
4. S.C. Code Regs. 61-81 (1989) sets forth the State Environmental Laboratory Certification
Program. This regulation was adopted on April 11, 1980 and has never been amended.
Laboratory certifications for the analysis of drinking water are acquired through the application of
this regulation. Specifically, the regulation sets forth criteria for the certification of laboratories
performing analyses of drinking water samples to assure compliance with the Federal Clean Water
Act, 33 U.S.C.A. §§1251 et seq. (West 1986 & Supp. 1996), and the State Safe Drinking Water
Act.
5. Section F of Regs. 61-81 states:
"It is the responsibility of the Department to inform laboratories certified under this
regulation...of requirements in acceptable procedures, methodology, techniques, facilities,
quality control, records keeping, and equipment, including the changes in those
requirements. At no time shall requirements be imposed on a laboratory as a condition of
certification that are not also imposed on the environmental laboratories of the
Department."
6. In 1978, the Federal Environmental Protection Agency adopted specific guidelines for the
certification of laboratories that analyze drinking water. These guidelines, entitled the Manual for
the Certification of Laboratories Analyzing Drinking Water, were revised in 1982 and again in
1990. The EPA manual provides guidelines for the certification of state operated laboratories,
such as the State Laboratory operated by DHEC, and suggested criteria for states to use in
certifying local laboratories. The 1990 revisions were necessary to clarify responsibilities
concerning laboratory certification programs, to reduce the time a laboratory can be "provisionally
certified," and improve feedback to EPA on laboratory performance.
7. The enforcement of regulations promulgated pursuant to the Federal Clean Water Act has
been primarily delegated to the states. In South Carolina, this enforcement responsibility rests
with the Department. Therefore, under the EPA manual, South Carolina is a "primacy" state.
Primacy states must have a certification program for local laboratories if all analyses are not
performed in the principal State Laboratory. Local laboratories and third party contract
laboratories in South Carolina are certified by the Department.
8. The criteria for the certification of local laboratories are located in Chapter III of the EPA
Manual. In primacy states where not all drinking water analyses are conducted at State-operated
laboratories, the states are required to establish a certification program for local laboratories.
Certification can be based either upon criteria contained in the EPA Manual or upon
State-developed equivalents in accordance with the Manual, as determined by EPA.
9. In its written report of the on-site evaluation of Petitioner, the Department cited Petitioner for
numerous violations of the EPA Manual. A majority of these deficiencies related to record
keeping.
10. The Department has failed to establish a certification program for local laboratories consistent
with the EPA Manual. Section F of Regs. 61-81 mandates the Department to inform laboratories
certified under this regulation of requirements in acceptable procedures, methodology, techniques,
facilities, quality control, records keeping, and equipment, including the changes in those
requirements. The Department's efforts to do so have been inadequate in this case. The
Department does not list any requirements in the regulation nor does it have a procedure to notify
laboratories of the applicable industry standards and amendments. In this case, the new
management of the laboratory had not been provided with any documents purporting to be the
department's certification requirements under Reg. 61-81(F). The regulations do not contain any
criteria about provisional certification as contained the EPA Manual. The Department's
regulations are not equivalent to the EPA Manual.
11. In addition, the Department has failed to establish specific criteria for certification of
laboratories. Instead, the Department relies on the criteria established by the EPA Manual without
citing the manual in the Regulation. Because the Department charges local laboratories to comply
with the requirements of the EPA Manual, it follows that local laboratories are entitled to all
remedies and procedures provided by the manual. This conclusion is bolstered by the second
sentence of Regs. 61-81 (F). It provides that requirements will not be imposed on a laboratory as
a condition of certification that are not also imposed on the State Laboratory. The State
Laboratory must also follow the guidelines of the EPA manual and it is subject to all of the
remedies contained in the Manual. Because the EPA Manual provides the Department with the
opportunity to be granted "provisionally certified" status, the Department must provide the same
opportunity to the laboratories it regulates.
12. As is provided in the Preface to the 1990 edition of the EPA Manual, the EPA is currently
developing new regulations to insure that all primacy states include in their certification programs
"those few basic elements that the EPA regards as critical to assuring data validity (e.g.,
certification downgrading procedures...)."
13. Certification downgrading includes "provisionally certified" status. Thus, this provision
should be incorporated into the Department's criteria.
14. Chapter III of the EPA Manual provides that a laboratory may be granted "provisionally
certified" status if the laboratory has deficiencies but demonstrates its ability to consistently
produce valid data. A laboratory will be downgraded to "provisionally certified" status for a
particular contaminant analysis for any of the following reasons:
a. Failure to analyze a Periodic Performance Evaluation sample within the acceptable
limits established by EPA;
b. Failure of a certified laboratory to notify the CA (Regional Administrator, or his
designee) within 30 days of major changes which might impair analytical capability (e.g., in
personnel, equipment, or laboratory location);
c. Failure to satisfy the CA that the laboratory is maintaining the required standard of
quality, based upon an EPA on-site evaluation; or
d. Failure to notify the State and/or public water system in a timely fashion of
unsatisfactory results on water samples, thereby preventing compliance with Federal and/or
State reporting requirements.
15. Petitioner is entitled to "provisionally certified" status as provided in the EPA Manual.
Once a laboratory has been downgraded to "provisionally certified" status, the laboratory must
correct its problem within three months for a procedural or administrative deficiency and within
six months for an equipment deficiency.
16. The Department must provide Petitioner a specific and detailed list of the deficiencies in the
laboratory program and what steps Petitioner must take to remedy the deficiencies. In addition,
pursuant to Reg. 61-81(f), the Department must provide Petitioner with all copies of all
documents containing the "requirements in acceptable procedures, methodology, techniques,
facilities, quality control, record keeping and equipment" within fifteen (15) days of the date of
this Order. If the laboratory continues to demonstrate an inability to comply with the applicable
criteria at the expiration of the requisite time period, the provisional certification is removed and
the laboratory is further downgraded to "not certified" status. See EPA Manual, p. 9.
ORDER
Based of the above Findings of Fact and Conclusions of Law, it is hereby ORDERED that
Petitioner is granted provisional certification status pursuant to the EPA Manual. The
Department within fifteen (15) days of the date of this Order shall provide Petitioner with the
documents as stated in the Conclusions of Law, #16. The Department, within thirty days of the
date of this Order, must provide Petitioner with a detailed list of criteria and deficiencies that
Petitioner must correct in order to achieve compliance with the EPA Manual and the expectations
of the Department. Petitioner's provisional certification begins the day it is receives the list of
deficiencies and the required remedies issued by the Department. The time period for the
correction of the deficiencies shall be based on the identified deficiencies and the time limits
established in the EPA Manual for Certification of Laboratories Analyzing Drinking Water, 1990
ed.
AND IT IS SO ORDERED.
______________________________
ALISON RENEE LEE
Administrative Law Judge
August____, 1996
Columbia, South Carolina. |