Current through Register Vol. 56, No. 18, September 16, 2024
(a) A laboratory
performing acute toxicity testing shall develop and implement a quality control
program. The laboratory shall not perform acute toxicity testing without having such
a program. The laboratory shall have a written description of its program on file
and be able to produce a copy during an on-site inspection. The written description
shall include all methods manuals used for culturing test organisms, and all testing
protocols used by the laboratory. The quality control program description, or
standard operating procedures (SOP) manual, shall be specific to the operations of
the laboratory and not a generalized document.
(b) The laboratory shall make records of all
analytical control tests and quality control checks on equipment and materials. The
laboratory shall maintain the records for at least five years. The laboratory shall
file and maintain data and other records in an accessible location on the
laboratory's premises for one year after the date of analysis so that reviews can be
conducted during on-site audits.
(c) If
the laboratory discovers an error in the analysis of a regulatory sample, and the
error may affect the validity of the reported analytical result, the environmental
laboratory manager shall report the error to the regulatory program for which the
analysis was conducted, and to the client. The laboratory shall make this
notification within 72 hours after discovery of the error.
(d) Laboratories performing acute toxicity testing
shall comply with the following requirements when performing quality control checks
of laboratory media, equipment, and supplies:
1.
Operate each pH meter in accordance with
7:18-3.3(a)3. Rinse the
probe with laboratory pure water immediately after each use period. Label commercial
buffer solutions with the date of receipt and the date of initial use;
2. Operate top loader or pan balances in
accordance with 7:18-3.3(a)2;
3. Verify all temperature measuring devices using
the procedures listed in
7:18-3.3(a)5;
4. The temperature of air or water-jacketed
incubators, aluminum block incubators, water baths, and incubator rooms shall be
recorded either continuously or daily from in-place thermometers immersed in liquid
and placed on at least one of the shelves in use. Keep the records in a log book,
signed and dated by the analyst;
5.
Record date, time, pressure and temperature of an autoclave either continuously, or
individually during each sterilization cycle. Keep the records in a log book, signed
and dated by the analyst;
6. The time
and temperature of hot air ovens shall be measured with a thermometer either
continuously or individually during each cycle, with the bulb of the thermometer
placed in sand. Record the date, time and temperature of each cycle. Keep the
records in a log book, signed and dated by the analyst;
7. Monitor the temperature of each refrigerator in
accordance with the procedures listed in
7:18-3.3(a)7;
8. Label all reagents and solutions to indicate
identity and, when applicable, titer, strength or concentration, manufacturer's
recommended storage requirements, preparation and expiration date, and other
information pertinent to identification. Do not use materials of substandard
reactivity or deteriorated materials. Discard all outdated material
immediately;
9. At least annually, check
conductivity and salinity meters equipped with conductivity cells having platinum
electrodes. Perform the check over the range of interest using at least five
concentrations of a standard potassium chloride solution. Check conductivity cells
not having platinum electrodes against a conductivity meter equipped with platinum
electrodes. Perform this check annually and record the raw data, cell constant, and
results in a log book, signed and dated by the analyst; and
10. Check dissolved oxygen meters weekly, using
the Winkler method. Record the results in a log book signed and dated by the
analyst.
(e) Only the
laboratory manager, supervisor or quality assurance officer is authorized to make
changes in laboratory procedures. Changes are effective only if:
1. The change is made by the manager, supervisor
or quality assurance officer of the laboratory;
2. The manager, supervisor or quality assurance
officer makes the change in writing, signed and dated by the manager, supervisor or
quality assurance officer, and includes the change in the laboratory's SOP
manual.
(f) A laboratory
shall not perform acute toxicity tests unless it keeps current laboratory SOP and
reference manuals in the immediate bench area of laboratory personnel engaged in
examining samples and performing toxicity testing and other related procedures. The
laboratory may use textbooks to supplement the manuals, but shall not replace the
manuals with the textbooks. The manuals shall include information relating to:
1. The analytical methods to be used, properly
designated and dated to reflect the most recent supervisory reviews; and
2. Any applicable regulations.
(g) A laboratory conducting a
flow-through toxicity test shall check the temperature in the exposure chambers, the
flow rate through the exposure chambers, and the maintenance of effluent
concentrations. The laboratory shall conduct these checks when the test is
initiated, at least once every 24 hours for the duration of the test, and upon
completion of the test. The laboratory shall document these measurements, and any
resulting adjustments to the flow-through dilutor system, in the toxicity test
report.
(h) A laboratory performing an
acute toxicity test shall establish an acute toxicity test precision requirement
that the 95 percent confidence interval be within +/-30 percent of the estimated or
incipient EC[50] or LC[50] value.
(i) A
laboratory performing acute toxicity tests shall keep records and report data in
accordance with the requirements of (i)1 and 2 below. The records to be retained
include raw data records, quality control data records, chain-of-custody forms,
laboratory reports, and the information required under (i)2 below.
1. The laboratory shall retain each record for at
least five years after the date of the analysis. The laboratory shall file and
maintain data and other records in an accessible location on the laboratory's
premises for one year after the date of analysis so that reviews can be conducted
during on-site audits.
2. The laboratory
shall record the following information as part of the daily log of feeding,
behavioral observations, and mortality of organisms during holding and acclimation:
i. The water temperature of holding
tanks;
ii. The air temperature in the
culturing/holding room;
iii. Mortalities
or organisms per holding tank;
iv. The
analysis of laboratory grade waters as specified in
7:18-7.4(b);
v. The food and feeding schedule; and
vi. General observations of behavior and
condition.
(j) The
laboratory shall not accept custody of regulatory samples unless a chain-of-custody
form is submitted with the samples, in accordance with
7:18-9.5(c).
1. Before accepting custody of a regulatory
sample, the laboratory shall determine that the sample is properly labeled and has
been collected, preserved, processed, stored and transported in accordance with the
provisions of this subchapter. If the sample fails to meet those requirements, the
laboratory shall indicate that failure on the chain-of-custody section of the sample
request form or the chain-of-custody form;
2. The laboratory's sample custodian accepting
responsibility for the sample shall sign the chain-of-custody form;
3. The laboratory shall have an internal
chain-of-custody procedure or an alternate sample tracking procedure which
establishes the integrity and completely tracks the custody of a sample during its
lifetime in the laboratory; and
4. If
the analysis was not performed at the environmental laboratory that first received
the sample, the chain-of-custody form shall include the name, address and
identification number of the New Jersey certified environmental laboratory to which
the sample was forwarded.
(k)
If a laboratory violates any of the requirements of this subchapter in the process
of performing an acute toxicity test, the laboratory shall prefix the test result,
that is, LC[50] or EC[50] value, with the letter "J," and describe the violation in
the "remarks" section of the test report.
