Regulatory Affairs - Statute and Regulations
SUBPART 55-2
APPROVAL OF LABORATORIES PERFORMING
ENVIRONMENTAL ANALYSIS
(Statutory Authority: Public Health Law, section 502)
| SEC. | |
| 55-2.1 | Definitions and criteria for separate laboratories |
| 55-2.2 | Categories of approval |
| 55-2.3 | Application for approval |
| 55-2.4 | Approval criteria |
| 55-2.5 | Limitation and termination of approval |
| 55-2.6 | Laboratory inspections |
| 55-2.7 | Proficiency testing program |
| 55-2.8 | Reciprocity agreements |
| 55-2.9 | Definition, environmental laboratory director |
| 55-2.10 | Qualifications of environmental laboratory directors |
| 55-2.11 | Qualifications of contract laboratory protocol personnel |
5-2.1 Definitions and criteria for separate laboratories.
(a) Definitions. For purposes of this Subpart, unless the context indicates otherwise, the following terms shall have the following meanings:
(1) Environmental laboratory means any facility that examines, or is available for the examination of, samples or specimens including, but not limited to: air, stack emissions, water, wastewater, surface water, ground water, recreational waters, swimming pools, leachate, land runoff, solid waste, hazardous waste, soil, sediments and vegetation, as well as any substance that could contribute to the pollution of or that could be contaminated by material contained in such samples or specimens. Such examinations shall be limited to qualitative or quantitative determinations of the biological, chemical, radiochemical or physical characteristics of such samples or specimens for the purposes of public or personal health protection, or the protection of the environment or natural resources. Environmental laboratories shall not include facilities or entities that perform non-laboratory chemical testing associated with residential water softeners and residential swimming pools. Environmental laboratories shall include mobile laboratories, as defined in paragraph (2) of this subdivision.(b) Criteria for separate laboratories.(2) Mobile laboratory means a separate, self-contained mobile facility for the examination of environmental samples or specimens as described in paragraph (1) of this subdivision. A mobile laboratory must have a fixed address, provided to the department with each application, to which proficiency test samples and other correspondence may be sent, and must be managed by a responsible person authorized to receive service of process.
(3) Director means the individual responsible for the technical and scientific operation of an environmental laboratory, who meets the minimum qualifications in sections 55-2.9 and 55-2.10 of this Subpart.
(4) Approved method means the analytical method, including sample preparation, which is determined by the department to produce data with a known level of precision and accuracy, and is comparable to historically used methods.
(5) Analyte means a chemical and/or physical property, element, compound, group of compounds, organism, or group of organisms, to be determined in samples examined.
(6) Statistical mean is the arithmetic average of a data set after outlier rejection, or if transformation is used, the central point of the data set distribution after outlier rejection.
(7) Method detection limit means the minimum concentration of an analyte which can be measured and reported, as defined or stated in the least sensitive approved method.
(8) Target value means the nominal concentration of an analyte, based on theoretical calculations.
(9) Relative standard deviation means the standard deviation of a data set divided by the statistical mean, expressed as a percentage.
(10) Synthetic blank means an artificial sample with contents of known purity and without added analytes.
(11) Natural blank means a sample derived from the environment, for which the concentration of a given analyte or analytes, after repeated analyses, has been determined to be below the method detection limit.
(12) Spiked sample means a sample to which a known amount of an analyte has been added.
(13) Natural sample means a sample collected from the environment, to which no analytes have been added.
(14) Contract Laboratory Protocol (CLP) means a protocol, issued by the Department of Environmental Conservation, for performance of environmental analyses in accordance with specifications describing the types of samples to be analyzed (such as soil or water); the internal sample-handling procedures (such as chain-of-custody or holding times); instrumentation and method of analysis to be used for each analyte; calibration procedures to be implemented (such as numbers of standards, their concentrations and acceptance criteria); quality control samples to be analyzed and the frequency of such analysis; and the organization and content of reports to be issued on analytical results obtained.
(15) CLP data package is a collection of documentation whose organization and content are specified by CLPs. A CLP data package consists of analytical reports, including, but not limited to, a narrative description of how the analysis was performed, any problems encountered, analytical results for all samples, results for all quality control samples analyzed, copies of instrument printouts, all logbook pages and laboratory bench sheets.
(16) Department means the New York State Department of Health.
(1) Testing facilities which are housed in separate buildings shall be considered separate laboratories unless such facilities obtain a waiver from the department pursuant to paragraph (2) of this subdivision.Back to Top(2) The department shall not waive the requirements of paragraph (1) of this subdivision unless it determines that:
(i) supervision of all such facilities can be exercised effectively by a single director of record, as defined in sections 55-2.9 and 55-2.10 of this Subpart;(ii) the testing facilities do not duplicate each other's analytical reporting and recordkeeping activities; and
(iii) the testing facilities are owned by the same legal entity.
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55-2.3 Application for approval.
An application shall be made to the department by the owner or director of the laboratory on a form prescribed by the department. No approval may be granted to any laboratory failing to supply all of the information requested on the application. The department may require additional information regarding the laboratory, including, but not limited to, its ownership, organization, testing program, premises, qualification of personnel, equipment, form of reporting analyses, and number of analyses performed each calendar year. Upon receipt of such application and any additional information requested, the department shall determine whether the laboratory qualifies for approval, the categories and subcategories for which approval is to be issued, and the annual fee to be paid. Prior to the issuance or renewal of a certificate of approval, the approval fee must be paid, unless otherwise expressly authorized by the department pursuant to Subpart 55-3 of this Part.
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(a) In such form as may be prescribed by the department, the laboratory owner or director shall certify that:
(1) the laboratory will operate in accordance with section 502 of the Public Health Law, the provisions of this Title and/or section 3-0119 of the Environmental Conservation Law;(2) the owner or director will monitor and document the use of approved methods;
(3) records will be maintained for not less than three years to identify precisely the samples collected, accepted and examined, procedures used and personnel involved, and to document test conditions, observations and results of examinations;
(4) records of chemical analyses related to potable water supplies will be maintained for not less than 10 years; and
(5) the laboratory will notify the department if the laboratory is found to be in violation of any federal, state or local law by the federal, state or local agency enforcing that law.
(b) Interim approval.
(1) Interim approval shall be granted to a laboratory in the categories, subcategories or analytes sought in the application for approval, provided the laboratory director submits documentation of his or her qualifications, as defined in section 55-2.10 of this Subpart, and of the capability of the laboratory to adhere to approved methods in accordance with generally accepted scientific principles.(2) The determination regarding interim approval shall be made after review of the proposed director's qualifications, character, competence and standing in the community. Such review shall include, but not be limited to:
(i) prior sustained charges of administrative violations of state or federal laws, rules and regulations related to the provision of environmental laboratory services or reimbursement for such services, against the applicant individually or against any laboratory directed by the applicant;(3) If the laboratory or any of its personnel has at any time not fully complied with Public Health Law section 502 or the requirements of this Part, or is/are found to be in violation of any other federal, state or local law concerned with laboratory operation by the federal, state or local agency enforcing that law, the department may also require that either one or both of the following requirements be met prior to the issuance of an interim certificate of approval:(ii) conviction of any crime, including, but not limited to, any offense relating to the furnishing of, or billing for, environmental laboratory services, which is considered an offense involving theft or fraud;
(iii) consideration of whether any laboratory directed by the applicant has demonstrated a pattern of repetitive failures of required proficiency testing performance in one or more proficiency testing categories, excluding failure for administrative reasons such as late result submission;
(iv) consideration of whether any laboratory directed by the applicant issued any reports on laboratory work, including work both on samples and proficiency testing, actually performed in another laboratory, without disclosing the fact that the examinations or procedures were performed in another laboratory; and
(v) any other factor having a direct bearing on the applicant's ability to provide or supervise the provision of high quality environmental laboratory services, or to ensure compliance with statutory and regulatory requirements.
(i) the satisfactory outcome of an onsite inspection; and/or(c) Final approval shall be granted in the categories and subcategories requested provided the applicant laboratory, in examining the proficiency test samples provided by the department and described in section 55-2.7 of this Subpart, demonstrates accurate performance, for the equivalent of two full years of proficiency tests, in the subcategory or analyte for which the laboratory seeks approval and provided the findings of two onsite inspections indicate compliance with the staffing, methodological and other requirements of this Subpart.(ii) demonstration by the laboratory, in examining proficiency test samples, that it can accurately determine all of the analytes for which the laboratory seeks approval.
(d) A certificate of approval shall be issued to a laboratory, setting forth:
(1) the nature of the approval (interim or final);(e) While an inspection is pending and during any extension or grace periods permitted by this Subpart, a laboratory approval shall remain in force beyond the expiration date of the certificate of approval, unless such approval is specifically terminated or suspended in writing.(2) the approved categories, subcategories and analytes;
(3) the name of the laboratory director; and
(4) the date of expiration of the approval, which date shall be no later than one year from the date the certificate of approval is issued unless an earlier date is set forth on the certificate.
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55-2.5 Limitation and termination of approval.
(a) Approval may be suspended, limited or terminated for any of the following reasons:
(1) failure to pass an inspection, as described in section 55-2.6 of this Subpart;(2) failure to participate in the examination of any regularly scheduled proficiency test samples distributed by the department;
(3) submitting to the department proficiency sample test results which in fact were generated by a laboratory other than the laboratory to which the samples were sent by the department;
(4) misrepresenting any material fact pertinent to an approval, pursuant to section 55-2.4(a) of this Subpart;
(5) misrepresenting the types of analyses for which the laboratory is approved;
(6) issuing a report on laboratory work actually performed in another laboratory without clearly and conspicuously identifying the examining laboratory on the report;
(7) aiding in the violation of any of the provisions of this Subpart;
(8) a finding by a municipality that a laboratory has violated a local ordinance relating either to the collection and analysis of samples or specimens or to the reporting of results for the examination of said samples or specimens; and
(9) falsifying any report of or relating to a laboratory analysis.
(b) No final approval may be limited or terminated for grounds other than failure to achieve a passing score or participate in the examination of any proficiency test samples, without a hearing or an opportunity for a hearing. An application for final approval may be denied and an interim approval terminated without a hearing. An approval shall be automatically suspended while any hearing requested is pending, provided that the hearing is scheduled to begin within 90 days of the request for such hearing.
(c) An approval shall be automatically terminated upon a change in ownership, directorship and/or location of the laboratory.
(d) An approval may be extended for a period not to exceed 90 days after any change in laboratory ownership, directorship and/or location, in order to permit the department to evaluate:
(1) the qualifications, character and competence of the new director, provided that notification of such change was made in writing to the department within 20 business days of the change and a temporary director is designated in accordance with section 55-2.9 of this Subpart;(2) the effect of the change in location on the laboratory's ability to produce accurate and precise analytical data, provided that notification of such change was made in writing to the department within 20 business days of the change; and
(3) the character and competence of the new owner(s). Additional extensions, as specified under section 55-2.6(e) of this Subpart, may be granted provided all approval fee payments required by Subpart 55-3 of this Part have been made.
(e) An approval fee must be paid prior to the issuance or renewal of a certificate of approval, unless otherwise expressly authorized by the department.
(f) If a laboratory has lost approval for the determination of one or more analytes because of poor performance in examining proficiency test samples, the department shall require demonstration of accuracy in examining such samples before considering an application for reapproval from that laboratory or from any person who was an owner or director of said laboratory on the date of notification of loss of approval. The department may require an inspection of the laboratory before acting on an application for approval or reapproval, if the laboratory or any of its personnel has not fully complied with the requirements of the Public Health Law section 502, or this Part, or has been found to be in violation of any other federal, state or local law concerned with laboratory operation by the federal, state or local agency enforcing that law.
(g) If a laboratory's approval has been terminated due to a violation of paragraph (3), (4), (5), (6), (7), (8) and/or (9) of subdivision (a) of this section, and the department finds that the violation was intentional, or due to recklessness or gross negligence, no application shall, for a period of time to be recommended by a hearing officer, be accepted from any person who was an owner or director of said laboratory on the date of notification of loss of approval.
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55-2.6 Laboratory inspections.
(a) Laboratories seeking or holding approval under this Part shall, as a condition of approval, permit department inspections during their normal business hours.
(b) The factors to be considered by the department during inspections shall include, but shall not be limited to, competence and qualifications of staff, adequacy of facilities and equipment, appropriate sampling protocols, use of analytical methods and quality control procedures, and recordkeeping and reporting practices as specified in this Subpart.
(c) Each laboratory shall, following each inspection, be furnished with an inspection report which shall set forth the findings of the inspection and deficiencies, if any, to be corrected.
(d) Laboratories located outside of the State of New York shall be assessed the approval fee specified in Subpart 55-3 of this Part, plus additional expenses incurred in inspecting them. Such inspections shall not be performed before receipt by the department of payment for additional inspection costs.
(e) If deficiencies are found during an inspection, the laboratory may be granted a grace period not to exceed 90 days from the date of notification to correct the deficiencies, provided that, within 20 business days of notification, the laboratory submits to the department a written plan of correction to be implemented within 90 days. If this grace period extends beyond the expiration date of the certificate of approval, that approval shall be automatically extended through that period. If, at the end of the grace period, any of the deficiencies found remain uncorrected, approval may be limited or terminated pursuant to section 55-2.5 of this Subpart. If the deficiencies found do not necessarily or immediately affect either the accuracy or precision of results, and if the laboratory demonstrates in writing that corrections of deficiencies are delayed for reasons beyond its control, the grace period granted pursuant to this subdivision may be further extended for a period not to exceed 90 days. Such extension may not be further renewed.
(f) Laboratory directors shall, 20 business days prior to the beginning of any remodeling that may affect the quality of analytical data, advise the department in writing of the precise nature of the changes to be made.
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55-2.7 Proficiency testing program.
(a) Laboratories shall, examine proficiency test samples as supplied by the department. Laboratories shall conduct the specified examinations and shall submit the results of testing to the department for all analytes for which they are approved and for which samples have been supplied.
(1) A schedule for mailed proficiency test sample distribution shall be announced to laboratories as soon as practicable after the first day of each permit year. The frequency and dates of distribution shall be included in this announcement. Laboratories shall report test results to the department no later than on the dates specified for each form of submittal described in letters of sample transmittal which shall specify the scoring criteria to be used by the department. No extensions may be granted. Laboratories whose results are received after the deadline shall be considered to have failed to participate in the examination of samples.(b) Performance in examining an individual chemical or physical analyte shall be evaluated as follows for a natural blank test sample:(2) The department may also require laboratories to analyze proficiency test samples hand-carried to the laboratory by the department's representatives. Such samples shall be analyzed in the presence of the department's representatives and will be required to be analyzed only if they can be integrated into routine analytical runs being performed at the time.
(1) Good performance is a result reported with or without the term "less than" and having a value less than or equal to the method detection limit.(c) Performance in examining an individual chemical or physical analyte shall be evaluated as follows for a synthetic blank test sample:(2) Marginal performance is a result, reported with or without the term "less than," greater than the method detection limit, but less than or equal to twice the method detection limit, excluding results for tests for which data are scored during a fixed percentage of the target value.
(3) Unsatisfactory performance is a result, reported with or without the term "less than," greater than twice the method detection limit, or a value greater than the method detection limit if data are scored using a fixed percentage of the target value.
(1) Good performance is a result reported with the term "less than" and having a value less than or equal to the method limit.(d) Performance in examining an individual chemical or physical analyte shall be evaluated as follows for a spiked or natural test sample:(2) Marginal performance is a result reported with the term "less than" and having a value greater than the method detection limit but less than or equal to twice the method detection limit.
(3) Unsatisfactory performance is a result reported with or without the term "less than" and having a value greater than or equal to twice the method detection limit.
(1) For data sets examined by the standard statistical procedures described in subdivision (g) of this section and having a relative standard deviation lower than 34 percent:(e) Performance in examining an individual bacteriological analyte for which quantitation is required shall be evaluated as follows:
(i) good performance is a result within the 95-percent confidence limits about the statistical mean;(2) For data sets examined by the standard statistical procedures described in subdivision (g) of this section but having a relative standard deviation of 34 percent or higher, the relative standard deviation of the data set used for determining the 95- and 99-percent confidence intervals shall be set at 34 percent, or a value derived from the scientific literature. Good, marginal and unsatisfactory performance shall be described in subdivision (d)(1) of this section.(ii) marginal performance is a result outside the 95-percent confidence interval, but within the 99-percent confidence interval about the statistical mean; or
(iii) unsatisfactory performance is a result outside the 99-percent confidence interval about the statistical mean.
(3) For data sets evaluated by using a reference laboratory panel, statistical mean and 95- and 99-percent confidence limits shall be derived from the reference laboratory data set, after standard statistical analysis. Good, marginal and unsatisfactory performance shall be as described in subdivision (d)(1) of this section.
(4) For data sets evaluated using an interval about the target value and defined by a fixed percentage of the target value, fixed percentages shall be set based on the department's determination of the reliability, precision and accuracy of the methods:
(i) good performance is a result within the fixed percentage interval about the target value; or(ii) unsatisfactory performance is a result outside the fixed percentage interval about the target value.
(1) For negative coliform and/or standard plate count test samples, including sterile samples, samples which contain bacteria not detectable by the method described in the proficiency test instructions, and samples which contain bacteria not producing positive reactions with the required verification procedures, good performance is a result reported as a value lower than the method detection limit for the method prescribed in the proficiency test instructions. Unsatisfactory performance is any other result.(2) Performance in examining an individual bacteriological analyte for which quantitation is required shall be evaluated as follows for a positive inoculated test sample:
(i) Good performance is a result within the 95-percent confidence interval about the statistical mean for Most Probable Number (MPN), Membrane Filter (MF) coliform or standard plate count data.(f) The statistical mean and the 95-percent and 99-percent confidence intervals used to determine good, marginal and unsatisfactory performance for spiked and natural chemical test samples and positive inoculated MF coliform and standard plate count test samples shall be established from a statistical analysis of the data set after rejection or weighting of outliers, as described in subdivision (g) of this section. The target value shall be the mean of the resulting data set.(ii) Marginal performance is a result outside the 95-percent confidence interval, but within the 99-percent confidence interval about the statistical mean for MPN or MF coliform or standard plate count data.
(iii) Unsatisfactory performance is a result outside the 99-percent confidence interval about the statistical mean for MPN or MF coliform or standard plate count data.
(g) Rejection of outliers in a chemical data set shall be based on the three-standard deviation interval, after eliminating the extreme values in the data set and all values exceeding twice the theoretical value for the test sample. Rejection of outliers in an MF coliform or standard plate count data set shall be based on the three-standard deviation interval, after eliminating the extreme values in the data set. Weighting of outliers, if used in place of rejection of outliers, shall be accomplished using robust analysis. The statistical mean and the 95-percent and 99-percent confidence intervals used to determine good, marginal and unsatisfactory performance for positive inoculated MPN coliform test samples shall be based on the log normal distribution.
(h) Performance in examining potable water bacteriological samples qualitatively shall be evaluated based upon the known presence or absence of total coliform group members of Escherichia coli (E. coli). Satisfactory performance is a result correctly indicating the presence or absence of total coliform bacteria and correct identification of E. coli, if present. Unsatisfactory performance is a result incorrectly identifying the presence or absence of total coliform bacteria or E. coli.
(i) The score for the two consecutive proficiency tests shall be calculated for each analyte and expressed as a percentage, as follows:
(good results x 4) + (marginal results x 2) x 100
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(total results x 4)
Except as provided below, the passing score for two consecutive proficiency tests for an individual analyte shall be 75 percent. A laboratory seeking or wishing to maintain individual analyte approval must attain a passing score of 75 percent or higher for that analyte in order to obtain final approval, and must maintain a passing score of 75 percent or higher to retain approval. A laboratory with interim approval must achieve a score of 75 percent or higher for final approval. A laboratory may have its interim approval status suspended if more than 50 percent of its analyses are rated unsatisfactory in the first proficiency test. An approved laboratory whose score on two consecutive proficiency tests for an analyte or a group of analytes is lower than 75 percent shall lose approval for that analyte or group of analytes.
(j) (1) In order to maintain approval for the potable water, volatile halocarbons, volatile aromatics or microextractables subcategories, a laboratory shall attain for two consecutive proficiency tests, the following minimum passing scores:
(i) for volatile halocarbons: 50 of the 56 analytical results in a proficiency test round evaluated as good;(ii) for volatile aromatics: 45 of the 50 analytical results in a proficiency test round evaluated as good; and
(iii) for microextractables: 3 of the 4 analytical results in a proficiency test round evaluated as good.
(2) In addition to maintaining passing scores as described above, a laboratory shall attain at least two good performance result evaluations for a given analyte within the above subcategories for two proficiency tests.(k) To maintain approval for the potable water-total coliforms analyte, for which proficiency testing requires qualitative analysis, a laboratory shall maintain an average score of 90 percent for two consecutive proficiency tests.(3) To gain approval for the subcategories in paragraph (1) above, a laboratory shall first attain a passing score as described in this Subpart.
(l) To gain or maintain approval in the Contract Laboratory Protocol tier, a laboratory shall be evaluated on both proficiency test performance and conformity of the data package submission to the contract requirements.
(m) If a laboratory's approval, or portion thereof, is subject to termination due to a failing score in the proficiency test, the department shall require the laboratory director to submit, within a period not to exceed 30 days from the date of notification of failure, a written statement of the reasons the laboratory's approval should not be terminated, the reasons for the unsatisfactory performance, and the corrective actions taken. The department may determine not to terminate the laboratory's approval or portion thereof if, based on the laboratory director's statement, a reasonable assumption may be made that the conditions causing the unsatisfactory performance no longer exists.
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55-2.8 Reciprocity agreements.
The department may enter into agreements with any other state for the purpose of recognizing, on the basis of reciprocity, laboratory inspections performed or laboratory approvals granted by such other state, provided that the program of the other state is satisfactory to the department. Reciprocal approval may be granted to laboratories located in states with which the department has concluded agreements of reciprocity, provided that candidate laboratories in such other states pay all applicable approval fees and additional costs incurred in the performance of inspections conducted pursuant to this Subpart.
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55-2.9 Definition, environmental laboratory director.
Environmental laboratory director means a full-time member of the staff of an environmental laboratory who exercises actual day-to-day supervision of laboratory procedures and reporting of results. The director's duties shall include, but not be limited to, monitoring standards of performance in quality control and quality assurance; monitoring the validity of the analyses performed and data generated in the laboratory to assure reliable data; ensuring that sufficient numbers of qualified personnel are employed to supervise and perform the work of the laboratory; and providing educational direction to laboratory staff. An individual meeting the requirements of section 55-2.10 of this Subpart may not be the director or assistant director of record of more than one approved environmental laboratory without authorization from the department. Circumstances to be considered in the decision to grant such authorization may include, but not be limited to, the extent to which operating hours of the laboratories to be directed overlap, adequacy of supervision in each laboratory, and the availability of environmental laboratory services in the area served. A director who is absent for a period of time exceeding 10 consecutive business days shall designate another full-time staff member meeting the qualifications of laboratory director to act temporarily as director. If the temporary directorship term exceeds 21 consecutive business days, the department shall be notified of the change in writing. Such temporary directorship shall not exceed 40 consecutive business days in a permit year.
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55-2.10 Qualifications of environmental laboratory directors.
(a) A director of an approved environmental laboratory engaged in chemical analysis shall be one of the following:
(1) a person with an earned doctoral degree in the chemical, environmental or biological sciences, with a minimum of 24 college semester credit hours in chemistry and at least six months of experience, obtained under the supervision of a director meeting the requirements of this Subpart, in the environmental analysis of representative inorganic and organic analytes for which the laboratory is seeking approval;(b) The director of a laboratory holding or seeking approval for the Contract Laboratory Protocol tier, in addition to meeting the requirements of subdivision (a) above, shall have a minimum of three years of experience, at least one year of which shall be in a supervisory capacity.(2) a person with a master's degree in the chemical, environmental or biological sciences, with a minimum of 24 college semester credit hours in chemistry. In addition, such a person shall have at least one year of experience, obtained under the supervision of a director meeting the requirements of this Subpart, in the environmental analysis of representative inorganic and organic analytes for which the laboratory is seeking approval; or
(3) a person with a bachelor's degree in the chemical, environmental or biological sciences, with a minimum of 24 college semester credit hours in chemistry. In addition, such a person shall have at least two years of experience, obtained under the supervision of a direct meeting the requirements of this Subpart, in the environmental analysis of representative inorganic and organic analytes for which the laboratory is seeking approval.
(c) A director of an approved environmental laboratory engaged in, but limited to, inorganic chemical analysis, other than Contract Laboratory Protocol or metals analysis, shall be a person with an earned associate's degree in the chemical or environmental sciences, or two years of equivalent and successful college education, with a minimum of 16 college semester credit hours in chemistry. In addition, such a person shall have at least two years of experience, under the supervision of a director meeting the requirements of this Subpart, in environmental analysis.
(d) A director of an approved environmental laboratory engaged in microbiological testing shall be one of the following:
(1) a person with an earned doctoral degree or master's degree in an appropriate field of the sciences or applied sciences, with a minimum of four college semester credit hours in general microbiology and six months of experience under the supervision of a director who meets the requirements of this Subpart, in environmental analysis; or(e) A director of an approved environmental laboratory engaged in radiological analysis shall be one of the following:(2) a person with a bachelor's degree or an associate's degree in an appropriate field of the sciences or applied sciences, with a minimum of four college semester credit hours in general microbiology. Two years of equivalent and successful college education, including the microbiology requirement, may be substituted for the associate's degree. In addition, each person shall have one year of experience, obtained under the supervision of a person who meets the requirements of this Subpart, in environmental analysis.
(1) a person with an earned doctoral degree in radiation or nuclear chemistry and at least six months of experience in the radiological analysis of environmental samples;(f) A person who, on the date a laboratory first becomes subject to the requirements of section 502 of the Public Health Law or on the date the first certificate of approval is issued for any category as specified in section 55-2.2 of this Subpart, is director of a laboratory performing the work requiring that category of approval, and who can demonstrate the ability to comply with the department's proficiency testing and quality control requirements may qualify as director of that laboratory, even though he or she does not fulfill the college degree and credit hour requirements set forth in subdivisions (a) through (e) of this section. Application from such persons for department waiver of these requirements shall be received no later than 12 months after the effective date of the category of approval.(2) a person with a master's degree in radiation or nuclear chemistry and one or more years of experience in the radiological analysis of environmental samples; or
(3) a person with a bachelor's degree in chemistry or physics and two or more years of experience, one of these in a supervisory capacity, in the radiological analysis of environmental samples.
(g) For laboratories engaged in environmental analysis in areas such as microbiology, organic chemistry, inorganic chemistry and radiological analysis, one or more persons hereafter known as assistant directors may complement the director, provided that each has an academic degree, and the required appropriate credit hours and years of experience as prescribed in subdivisions (a) through (e) of this section. The director and assistant directors shall each supervise only the areas of environmental analysis for which he or she meets the qualifications required by subdivisions (a) through (e) of this section.
(h) Notwithstanding any other provision of this section, a full-time employee of a drinking water or sewage treatment facility who holds a valid treatment plant operator's certificate appropriate to the nature and size of such facility shall be deemed to meet the educational and experience requirements serving as the director of the approved laboratory devoted exclusively to the examination of environmental samples taken within such facility. Such approval for a water treatment facility shall be limited to the determination of total dissolved solids, pH, temperature, alkalinity, acidity, total coliform organisms and standard plate count. Such approval for a sewage treatment facility shall be limited to the determination of biochemical oxygen demand, total solids, suspended solids, pH, temperature, alkalinity, acidity, and fecal coliform organisms. However, such approval for a sewage treatment facility may be extended to include determination of ammonia, total Kjeldahl nitrogen, nitrate, or total phosphorus, provided the full-time employee has successfully completed a specialized course of study, generally recognized by leading authorities in the field in the analysis of these substances.
(i) Notwithstanding any other provision of this section, a full-time employee of an industrial waste treatment facility with a minimum of one year of experience under supervision in environmental analysis shall be deemed to meet the requirements for serving as the director of an approved laboratory devoted exclusively to the examination of environmental samples taken within such facility for the determination of biochemical oxygen demand, total solids, suspended solids, pH, temperature, alkalinity, acidity, and fecal coliform organisms.
(j) The director of an environmental laboratory engaged in microscopic examination of asbestos and/or airborne fibers shall meet the following requirements:
(1) For procedures requiring the use of a transmission electron microscope, a bachelor's degree, successful completion of specialized courses in the use of the instrument, and one year of experience, under supervision, in the use of the instrument. Such experience shall include the identification of minerals.Back to Top(2) For procedures requiring the use of a polarized light microscope, an associate's degree or two years of college study, successful completion of formal coursework in polarized light microscopy, and one year of experience, under supervision, in the use of the instrument. Such experience shall include the identification of minerals.
(3) For procedures requiring the use of a phase contrast microscope, as in the determination of airborne fibers, an associate's degree or two years of college study, documentation of successful completion of formal coursework in phase contrast microscopy, and one year of experience, under supervision, in the use of the instrument.
(k) A director of an approved environmental laboratory engaged in the examination of radon in air shall have at least a bachelor's degree in the physical sciences and one year of experience in radiation measurements, including at least six months of experience in the measurement of radon and/or radon progeny.
55-2.11 Qualifications of Contract Laboratory Protocol personnel.
(a) In order to gain or maintain approval for Contract Laboratory Protocol analyses, a laboratory shall employ full-time employees qualified to perform the following functions, as set forth in the protocol:
(1) Laboratory supervisor in the specialties of gas chromatography/mass spectrometry (GC/MS), gas chromatography (GC), and/or inorganics shall be a person with at least a bachelor's degree in chemistry or the physical sciences, and three years of relevant laboratory experience, including one year in a supervisory capacity.(b) Each laboratory seeking or wishing to maintain approval for Contract Laboratory Protocol analysis shall have sufficient technical staff to provide continuous coverage, as appropriate, for the functions described in subdivision (a) above. The person or persons designated as back-up technical staff shall have at least a bachelor's degree in chemistry or the physical sciences, in addition to the following minimum experience:(2) GC/MS operator shall be a person with at least a bachelor's degree in chemistry or the physical sciences, and one year of experience in operating and maintaining a GC/MS data system. Three years of experience in operating and maintaining a GC/MS data system may be substituted for the educational requirement.
(3) Mass spectral interpretation specialist shall be a person with at least a bachelor's degree in chemistry or the physical sciences, who has successfully completed specialized training course(s) in mass spectral interpretation and has at least two years of experience in mass spectral interpretation.
(4) Pesticide residue analysis expert shall be a person with at least a bachelor's degree in chemistry or the physical sciences, and two years of experience in operating and maintaining a gas chromatograph and interpreting gas chromatograms.
(5) Organic sample preparation supervisor shall be a person with at least a bachelor's degree in chemistry or the physical sciences, and at least three years of organic laboratory experience, including at least one year in a supervisory capacity.
(6) Extraction/concentration expert shall be a person with at least a high school diploma, including one course in chemistry, and one year of experience in an analytical chemistry laboratory.
(7) Inductively coupled plasma (ICP) spectroscopist shall be a person with at least a bachelor's degree in chemistry or the physical sciences, who has successfully completed specialized training courses in ICP spectroscopy, and has two years of applied experience in ICP analysis of environmental samples.
(8) ICP operator shall be a person with at least a bachelor's degree in chemistry or the physical sciences, and one year of experience in the operation and maintenance of ICP instrumentation; or, in lieu of the educational requirement, four years of experience in the operation and maintenance of ICP instrumentation.
(9) Atomic absorption (AA) operator shall be a person with at least a bachelor's degree in chemistry or the physical sciences, and a minimum of one year of experience in operating and maintaining AA instrumentation for flame, graphite furnace and cold vapor techniques; or, in lieu of the educational requirement, three years of experience in operating and maintaining AA instrumentation as described above.
(10) Inorganic sample preparation specialist shall be a person with at least a high school diploma, successful completion of a college level course in general chemistry or its equivalent, and six months of experience in an analytical laboratory.
(11) Classical techniques analyst shall be a person with at least a bachelor's degree in chemistry or the physical sciences, and six months of experience in classical chemistry laboratory procedures; or, in lieu of the education requirement, two and one-half years of experience performing classical chemistry analyses.
(1) for organic chemistry protocols: one year of experience in each of the following areas: GC/MS operation and maintenance, for volatile and semi-volatile analyses; mass spectral interpretation; extraction; and pesticide analyses; orBack to Top(2) for inorganic chemistry protocols: one year of experience in each of the following areas: ICP operation and maintenance; AA operation and maintenance; classical chemistry analytical procedures; and sample preparation for inorganic analyses.