BILL ANALYSIS
SENATE COMMITTEE ON TOXICS AND PUBLIC SAFETY MANAGEMENT
Jack O'Connell, Chairman
1995-96 Regular Session
Bill No: AB 3475
Author: Committee on Environmental Safety and Toxic
Materials
Version: June 27, 1996
Hearing date: July 1, 1996
Consultant: Ben Firschein
ENVIRONMENTAL LABORATORIES
HISTORY:
Source: Association of California Testing Laboratories
(actLABS).
Support: American Association for Laboratory Accreditation
(A2LA); Erler & Kalinowski, Inc.; Altair Gases; APPL, INC.
(Agriculture & Priority Pollutants Laboratories, Inc.);
McFarland Energy, Inc.; Montgomery Watson Laboratories;
American Industrial Hygiene Association; Del Mar Analytical
Quanterra Environmental Services; Columbia Analytical
Services; LINC Quantum Analytics; Thermo Jarrell Ash; North
Coast Laboratories, Ltd.
Inchcape Testing Services Environmental Laboratories; FGL
environmental Analytical Chemists; American Environmental
Network, Inc.
Opposition: Not known
Assembly floor vote: 50-16
BACKGROUND AND EXISTING LAW:
Existing law requires certification by the Department of
Health Services of any laboratory processing samples for a
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number of purposes, including site characterization and
remediation programs; accepting waste for treatment,
storage, or disposal; conducting analyses of food for
pesticide chemical residues; and performance of needed
tests for drinking water and waste water systems. Existing
law allows the Department to grant reciprocity to
laboratories certified by another state, or an agency of
the federal government (but not by a private accreditation
organization).
PROPOSED LAW:
This bill requires that on or before June 30, 1998, the
Department of Health Services shall propose regulations
governing acceptance and approval of private third-party
laboratory accreditation organizations, and provides that
recognition of third-party laboratory accreditation shall
commence on or before December 31, 1998.
The bill provides that the regulations shall do the
following:
? Establish minimum requirements that assure that
accreditation examinations, and laboratory performance
levels are comparable to those required by the department.
The bill would allow an accrediting organization to
establish and implement standards that exceed the minimum
standards established by the department.
? The bill provides that evidence of the satisfactory
completion of accreditation of a laboratory by a third
party laboratory accreditation organization shall be
forwarded to the department for review and approval prior
to issuance of a certificate by the department.
? The bill would provide that whenever an accredited
laboratory that has been issued a certificate pursuant to
the third party accreditation process is no longer
accredited by a third party accreditation organization, the
certificate shall be automatically revoked by the
department. However, the laboratory would be allowed to
apply to the department for immediate recertification. The
bill provides that immediate recertification may occur if
the department determines that the loss of accreditation
does not result in the laboratoryos failure to meet
requirements related to certified laboratories.
Senate Committee on Toxics and Public Safety Management
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? Establish procedures for notifying the Department of
Health Services when a privately-accredited laboratory
fails to meet appropriate performance criteria.
? Establish provisions for the department to periodically
review performance and procedures of approved third-party
laboratory accreditation and enforcement procedures,
including revocation of approval. The bill provides that
the department shall recover the costs of approving and
sustaining the approval of a third-party laboratory
accreditation organization from the person or entity
seeking that approval.
? The bill provides that a laboratory that is applying for
certification pursuant to third party accreditation shall
pay to the Department of Health Services an initial and
annual fee of two thousand dollars.
FISCAL EFFECT:
The prior version of the bill would have resulted in
potentially significant revenue loss to the certified labs
program administered by the Department of Health Services.
The recent amendments increase the fee from $500 in the
prior version of the bill to $2,000 in the most recent
version, therefore significantly diminishing the potential
revenue loss.
COMMENT:
1. This bill is sponsored by the Association of California
Testing Laboratories (actLABS). Under current law, any
laboratory processing samples for site characterization or
remediation programs or other specified services in the
state must be certified by the Department of Health
Services (or be certified by another state, or an agency of
the federal government, in a manner recognized by
California).
According to the sponsor, although DHS recognizes
laboratories accredited by government agencies in other
states, DHS does not recognize third party private
accreditation of a laboratory, even if it is demonstrably a
more thorough and effective accreditation than the
department can perform. The sponsor states that this bill
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will encourage the use of national and international
standards for laboratory accreditation that meet or exceed
the Departmentos standards, and will allow greater national
reciprocity. Similar legislation has been adopted in
Washington, Texas, New Mexico, and Kansas.
A third-party laboratory accreditation organization is
typically a private entity or organization such as a trade
organization. Some of these organizations are national or
international.
2. The Department of Health Services opposed the prior
version of this bill, raising two concerns:
? The department raised the concern that the shift in
certification fee revenues from the Department of Health
Services to third party accreditation organizations could
result in a substantial loss of revenue to the Department
of Health Services, and this revenue loss could hinder the
Departmentos effort to ensure that certified labs and
third-party accreditation organizations were performing
properly. To address this concern, the bill has been
amended to increase the fee that must be paid by a
laboratory to the department from $500 in the prior version
of the bill to $2,000 in the current version of the bill.
This compares to initial and annual fees in existing law of
$879, and additional fees in existing law of $396 for
certification in each field for which certification is
sought (23 fields total are possible fields of
certification).
? The prior version of the bill contained an oauto-triggero
provision that stated that in the event regulations
specified by the bill were not in effect on or before
December 31, 1998, the Department of Health Services would
be required to recognize accreditation of an environmental
testing laboratory by any third-party accreditation
organization, unless the department determined based on
substantial evidence that the recognition was not
comparable to department accreditation and not in the
interests of the state. That provision has been stricken
from the bill.
3. The National Environmental Laboratory Accreditation
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Page 5
Conference (NELAC)<1> has expressed concern that this bill
could undermine its efforts to come up with a uniform
national standard for environmental laboratories. Draft
standards have been under consideration by NELAC for the
past year. Adoption of the majority of the final standards
is expected this July at the next annual meeting of NELAC
to be held in Washington D.C., although implementation of
the standards may take a few years.
The draft NELAC standards allow states that have concerns
unique to them to add standards that are supplemental to
the NELAC standards, but provide that supplemental
standards are limited to the fields of testing, parameters,
and methods not included in the NELAC standards.
DTSC has raised the concern that this bill would put
California at odds with these NELAC standards, thereby
hampering national uniformity. However, another school of
thought would be that the benefits of allowing independent
certification that exceeds state or federal standards
outweighs the disadvantages of lack of national uniformity.
4. It would be helpful if the author could clarify the
following statement contained in a written copy of remarks
to the Assembly Committee on Appropriations:
If the department envisions writing a
regulatory program that would have the
department certify the accreditation service
and also participate in the management and
auditing of the third-party laboratories, then
the department has mis-construed the bill.
Does this mean that the Department would not have the
ability to inspect and audit laboratories accredited by
third-party accreditation organizations under the bill, but
would simply react to inspections and audits carried out
by third-party accreditation organizations? If so, is this
appropriate?
5. It appears that the interim certificate language also
applies to the third-party certification process. Is this
------------------------------
<1> NELAC was created in 1995, and currently has as its
members forty-eight states, three territories, eight
federal agencies, and a wide variety of private sector
organizations.
Senate Committee on Toxics and Public Safety Management
Page 6
the authoros intent? This needs to be clarified.
6. The prior version of the bill could have potentially
put the state out of compliance with the federal Safe
Drinking Water Act because it did not give the department
discretion as to whether to approve certification of a
laboratory approved by a third party certification entity.
An EPA memorandum related to the Safe Drinking Water Act
states that ostates employing a third party to assist in
certification must retain ultimate authority to decide
whether the individual laboratories will be certified; this
decision cannot be delegated to the third party.o The most
recent version of the bill attempts to solve that problem,
by providing that such certification is subject to oreview
and approvalo by the department. To ensure full
consistency with the federal Safe Drinking Water Act, is it
suggested that in addition, the following language be
added: othe department shall retain ultimate authority to
decide whether the laboratory shall be certified.o
7. The most recent version of the bill provides for
automatic revocation of a certificate by the department
whenever an accredited laboratory that has been issued a
certificate no longer is accredited by a third party
accreditation organization. Although the bill allows the
laboratory to apply for immediate recertification, the
provision poses potential due process problems. It is
recommended that the provision reference some
administrative procedure that affords sufficient due
process to the laboratory.
8. Technical amendment: for the sake of clarity, committee
staff recommends that paragraph (6) on page 4 be redrafted
as follows:
oA third party accreditation organization shall not be
prohibited from establishing and implementing, on its own
initiative, or at the request of a laboratory, standards
that exceed the minimum standards established by the
department.o
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