Governor’s Tracking No. AR 047
STATE OF
OFFICE OF ADMINISTRATIVE HEARINGS
FOR THE DEPARTMENT OF HEALTH
Public Health Laboratory Division
|
In the Matter of the
Adopted Rules of the Minnesota Department of Health Governing Accreditation
of Environmental Laboratories; |
ORDER ON REVIEW OF RULES UNDER MINNESOTA STATUTES, SECTION 14.26 |
The Minnesota Department of Health’s
Public Health Laboratory Division (“Department” or “Agency”) is seeking review
and approval of the above-entitled rules, which were adopted by the agency
without a hearing. Review and approval
is governed by Minn. Stat. § 14.26. On July
20, 2006, the Office of Administrative Hearings received the documents that must
be filed by the agency under Minn. Stat. § 14.26 and Minn. R. 1400.2310. Based upon a review of the written
submissions and filings, and for the reasons set out in the Memorandum which
follows,
IT
IS HEREBY ORDERED:
1.
The agency has
the statutory authority to adopt the rules.
2. The rules were adopted in compliance with all procedural requirements of Minnesota Statutes, chapter 14, and Minnesota Rules, chapter 1400, with the exception of one harmless error, as set forth in the Memorandum below.
3. The
following provisions of the adopted rules are DISAPPROVED as not meeting the requirements of Minnesota Rules, Part
1400.2100, items D and E: rule parts 4740.2050, subps. 1(F), 9(A), and 13(B);
4740.2060, subp. 3(B); 4740.2065, subp. 7; 4740.2070, subp. 10(A) and (B);
4740.2075, subps. 2 and 3; 4740.2099, item C; and 4740.2100, subp. 9(E). All other rule parts are approved.
4. Pursuant
to Minnesota Statutes, section 14.26, subdivision 3(b), and Minnesota Rules,
part 1400.2300, subpart 6, the rules will be submitted to the Chief
Administrative Law Judge for review
Dated: August 4, 2006 s/Barbara L. Neilson
_______________________________
BARBARA
L. NEILSON
Administrative
Law Judge
MEMORANDUM
Pursuant to Minnesota Statutes, Section
14.26, the agency has submitted these rules to the Administrative Law Judge for
a review as to legality. The rules
adopted by the Office of Administrative Hearings[1]
identify several types of circumstances under which a rule must be disapproved
by the Administrative Law Judge or the Chief Administrative Law Judge. These circumstances include situations in
which a rule was not adopted in compliance with procedural requirements unless
the judge finds that the error was harmless in nature and should be disregarded;
the rule is not rationally related to the agency’s objectives or the agency has
not demonstrated the need for and reasonableness of the rule; the rule is
substantially different than the rule as originally proposed and the agency did
not comply with required procedures; the rule grants undue discretion to the
agency; the rule is unconstitutional[2]
or illegal; the rule improperly delegates the agency’s powers to another
entity; or the proposal does not fall within the statutory definition of a “rule.”
In the present rulemaking process, the Administrative Law Judge has found eleven defects in the rules, one of which is a harmless procedural error. The Administrative Law Judge has also recommended ten technical corrections, as discussed below. The technical corrections do not reflect defects in the rules, but are merely recommendations for clarification to the rules that the Department may adopt if it chooses to do so. All other rule parts are approved.
Defects
Procedural Defect (Harmless Error)
The Administrative Law Judge finds that one harmless procedural
error has occurred in this rulemaking process.
The Department did not include a section in the Statement of Need and
Reasonableness (“SONAR”) addressing the “probable costs or consequences of not
adopting the proposed rule” as required by Minn. Stat. § 14.131. However, by reading the discussion of the
other regulatory factors included in the SONAR, the reader can infer the
consequences of not adopting the proposed rules. It is the determination of the Administrative
Law Judge that this omission from the SONAR did not deprive any person or
entity of an opportunity to participate meaningfully in the rulemaking
process. It therefore constitutes a
harmless error under Minnesota Statutes, section 14.26, subdivision (3)(d)(1),
and Minnesota Rules part 1400.2100(A).
Defects under
The Administrative Law Judge has identified
ten other defects in the rules based upon vagueness or undue discretion. Each of these is discussed below.
Minn. R.
4740.2050, subp. 1, item F (page 13, lines 20-24 of Revisor’s draft dated June
23, 2006)
The agency proposes to add language to its base
certification requirements as follows: “If a laboratory fails to submit a
renewal application within 90 days before the expiration of certification, the
commissioner may notify the
regulatory authorities that receive data that the laboratory did not apply to
renew its certification.” (Emphasis added.)
As written, the rule part is unduly vague and grants
the Commissioner undue discretion in that it contains no criteria as to how the
Commissioner will decide whether or not to notify the regulatory
authorities. The proposed rule merely
gives the Commissioner the option of notifying the regulatory authorities, and
regulated parties have no way of knowing under what circumstances the
Commissioner will or will not notify the regulatory authorities. To correct the defect, the Administrative Law
Judge recommends that the agency either replace “may” with “shall” so that
regulatory authorities are notified in all instances or, in the alternative,
include criteria in the rule that the Commissioner will use to decide whether
or not notification will occur. Changing
the proposed language in accordance with the recommendation of the Administrative
Law Judge is needed and reasonable, and will not make rule part 4740.2050
substantially different than originally proposed.
Minn. R. 4740.2050, subp. 9, item A
(page 19, lines 9-14)
The agency proposes to add language to
the rule part regarding suspensions as follows:
“If a laboratory takes corrective action before the end of the
suspension period, certification for the suspended fields of testing or for the
base certification and fields of testing may
be restored if the corrective actions satisfactorily address the deficiencies
cited in the notice of suspension.” (Emphasis added.)
As written, the rule part is unduly vague and grants
undue discretion to the Commissioner because it does not provide adequate
guidance to the Commissioner regarding the standard to be used in deciding
whether or not to restore the certification once corrective action has been
taken to address deficiencies. The
agency has indicated that it will restore the certification except when prohibited
by a reciprocity agreement. In
accordance with the agency’s intentions, and to correct the defect, the Administrative
Law Judge recommends that the agency amend the rule language as follows or in a
similar manner: “. . . base certification and fields of testing may shall
be restored if the corrective actions satisfactorily address the deficiencies
cited in the notice of suspension, except when contrary to an applicable
reciprocity agreement.” Changing the
proposed language in accordance with the recommendation of the Administrative
Law Judge is needed and reasonable, and will not make rule part 4740.2050
substantially different than originally proposed.
Minn. R.
4740.2050, subp. 13, item B (page 26, lines 15-16)
As written, the rule states that the
Commissioner “may” specify an expiration date for a variance granted under this
rule part. The language of the rule is unduly
discretionary and vague because no standard is specified by which the
Commissioner is to determine whether or not to specify an expiration date and regulated
laboratories will not necessarily know if or when an approved variance will
expire. The agency has indicated that it
will specify expiration dates for granted variances except when the EPA has
given nationwide approval for the use of a particular method. Accordingly, the agency can correct the
defect by amending the language as follows or in a similar manner: “The commissioner may shall
specify an expiration date for the variances the commissioner issues.” Changing the proposed language in accordance
with the recommendation of the Administrative Law Judge is needed and
reasonable, and will not make rule part 4740.2050 substantially different than
originally proposed.
Minn. R.
4740.2060, subp. 3, item B (page 30, line 27)
This portion of the proposed rules relates to methods
required for certification with respect to the clean water program, the safe
drinking water program, the resource conservation recovery program, and the
underground storage tank program. The
proposed rules outline a procedure for a laboratory to seek approval to use
alternative methods and apply for a variance with respect to all of these
programs except the safe drinking water program. With respect to the safe drinking water program,
the rule indicates that the methods are provided under chapter 4720 and 40
C.F.R. parts 141 and 143, and states that “no alternative methods may be
used.” The agency’s Statement of Need
and Reasonableness indicates that this approach was taken “because the applicable
federal regulation prohibits approval of method modifications for drinking
water analysis.”
This language constitutes a defect in the rule because,
by foreclosing any consideration of variance requests under the safe water
drinking program, it grants the agency discretion beyond what is allowed by
applicable law. The Minnesota
Administrative Procedure Act accords persons and entities the right to petition
an agency for a variance from a rule adopted by the agency as it applies to the
circumstances of the petitioner.[3] Although agencies may grant variances based
on standards specified in other laws,[4]
and the Commissioner here may decide to deny variance requests to use
alternative methods under the safe drinking water program based on the current
federal regulation prohibiting approval of method modifications, the proposed
rule is defective because it has the effect of denying persons regulated by the
rule the right to submit a variance request even if the federal regulation is
subsequently changed or some other compelling reason exists. This defect can be corrected by deleting item
B of subpart 3 and adding new items B – D to that subpart that echo the
language used in Subparts 2, 4, and 5 relating to the other programs. Changing the language of the rule in
accordance with the recommendation of the Administrative Law Judge is needed
and reasonable, and will not make rule part 4740.2060 substantially different
than originally proposed.
Minn. R.
4740.2065, subp. 7 (page 35, lines 2-4)
The agency proposes the following
language regarding laboratory standard operating procedure manuals: “The laboratory standard operating procedures
manual is subject to approval by the commissioner.”
The language of the rule part does not specify the
criteria that the Commissioner will consider when evaluating a standard
operating procedures (SOP) manual, thereby giving the Commissioner undue
discretion in making determinations about SOP manuals. The agency indicated that the other subparts
of this rule part, specifically subparts 3 and 8, will form the basis for the
Commissioner’s evaluation. But the
agency also stated that other factors will play a role in the determination,
such as the experience of the laboratory staff or the number of laboratory
staff members. To correct this defect,
the agency must amend the language to identify the factors that will be used in
evaluating SOP manuals, preferably including references to subparts 3 and 8 and
any other criteria that the Commissioner will use. Changing the proposed language in accordance
with the recommendation of the Administrative Law Judge is needed and
reasonable, and will not make rule part 4740.2065 substantially different than
originally proposed.
Minn. R.
4740.2070, subp. 10, items A and B (page 39, lines 6 and 20)
The language of subpart 10 addresses the availability
of proficiency testing (“PT”) samples.
Item A states that the Commissioner “may” determine that a PT sample is
not available for a particular field of testing if certain circumstances exist,
and item B states that the Commissioner “may” request written documentation
from the laboratory regarding quality control data if no approved provider has
PT samples for a field of testing.
No standards are specified in the rule to govern the
exercise of the Commissioner’s discretion.
The unfettered discretion granted to the Commissioner by this rule
language creates a defect in the rules. The
defect may be corrected by replacing these two occurrences of “may” with “shall.”
Changing the proposed language in
accordance with the recommendation of the Administrative Law Judge is needed
and reasonable, and will not make rule part 4740.2070 substantially different
than originally proposed.
Minn. R.
4740.2075, subp. 2 (page 40, lines 4-5)
The proposed language states that the
Commissioner “may” approve a PT provider if the PT provider meets specified
criteria, which are recited on pages 40-42.
As written, the language of the rule part requires PT
providers to demonstrate that they satisfy a lengthy list of criteria as part
of the approval process but then does not require the Commissioner to approve
the provider, even if all the criteria are met.
The unlimited discretion granted to the Commissioner to deny approval
even where the criteria are met creates a defect in the rules. This defect can be corrected by the agency by
changing the word “may” to “shall.” Changing
the proposed language in accordance with the recommendation of the Administrative
Law Judge is needed and reasonable, and will not make rule part 4740.2075
substantially different than originally proposed.
Minn.
R. 4740.2075, subp. 3 (page 42, lines 19-26)
The proposed language states,
“Proficiency testing providers that fail to establish or maintain a quality
system meeting the requirements of this part are subject to loss of approval by
determination of the commissioner.
Providers may lose approval
to supply PT samples for particular fields of testing based upon review of
proficiency testing sample data or may
lose approval as a PT provider for all fields of testing if the PT provider
fails to meet the requirements of this part.”
(Emphasis added.)
Again, the language is vague and
grants undue discretion to the Commissioner to determine whether or not to
remove a provider from the list of approved PT providers. To correct the defect and also clarify the apparent
intent of the rule, the Administrative Law Judge recommends that the current
language be replaced by the following or similar language: “In order to obtain and maintain the
Commissioner’s approval as a PT provider for all fields of testing or obtain
and maintain the Commissioner’s approval to supply PT samples for particular
fields of testing, providers must establish and maintain a quality system
meeting the requirements of this part,” Changing
the proposed language in accordance with the recommendation of the Administrative
Law Judge is needed and reasonable, and will not make rule part 4740.2075
substantially different than originally proposed.
As written, item C states, “Failure to
demonstrate the capability of an analyst may
result in suspension of certification for that field of testing.” (Emphasis added.) This language is vague and vests unlimited
discretion in the Commissioner. Because
an earlier rule part (4740.2050, subp. 9, item B(5)) already notifies regulated
parties that the grounds for suspension of certification include “failure of
the laboratory to maintain records that demonstrate the capability of laboratory
staff as required by 4740.2099,” the agency may, if it wishes, remedy this
defect by deleting this sentence from item C of part 4740.2099. However, if the agency wishes to emphasize
this point in part 4740.2099 as well, the defect can be corrected by replacing the
language at issue with the following (or similar) language: “Failure to maintain records that demonstrate
the capability of laboratory staff as required in this part is grounds for
suspension of certification under part 4740.2050, subpart 9.” The proposed language parallels the language
of 4740.2050, subp. 9, item B(5), and ensures consistency in the rules. Changing the proposed language in accordance
with the recommendation of the Administrative Law Judge is needed and
reasonable, and will not make rule part 4740.2099 substantially different than
originally proposed.
Minn.
R. 4740.2100, subp. 9, item E (page 77, lines 22-24)
The rule as written states in item E
that “[a] laboratory must document acceptance criteria for mass spectral
tuning. The criteria are subject to the
approval of the commissioner.” No
further information is given in the rule about this topic.
Because the language of the rule part does not specify
the criteria that the Commissioner will consider when determining whether to
approve a laboratory’s acceptance criteria, the rule is vague, fails to provide
regulated parties with fair notice of what will be expected, and gives the
Commissioner undue discretion in making such determinations. To correct this defect, the agency must amend
the language to refer to criteria or standards that will be used in evaluating
acceptance criteria. Changing the
proposed language in this manner is needed and reasonable, and will not make
rule part 4740.2100 substantially different than originally proposed.
Recommended Technical Corrections
The following discussion does not
relate to defects in the rules, but merely outlines recommendations for
clarification to the rules that the Department may adopt if it chooses to do
so. In each instance, adoption of the
suggested approach would be needed and reasonable and would not make the rule
part substantially different than the rule as originally proposed.
Minn. R.
4740.2010, subp. 1 (page 2, lines 4-12)
The current rule language states that the terms used
in parts 4740.2050 to 4740.2120 have the meanings given to them in the rule and
in chapters 1 through 6 of the National Environmental Laboratory Accreditation
Conference (NELAC) Standards, which are incorporated by reference. The proposed rules merely provide an Internet
address for the NELAC standards. Under
Minn. Stat. § 14.07, subd. 4, the Revisor’s certification that the form of the
rule is approved reflects the Revisor’s finding that the publication
incorporated by reference is conveniently available to the public. If possible, however, the agency should
consider adding to the rule information about other ways to locate the NELAC
Standards to ensure availability to those who may lack easy Internet
access.
Minn. R.
4740.2010, subp. 55 (page 10, lines 21-25)
The proposed rule defines “standard” in part to mean
“the certified reference materials produced by the U.S. National Institute of
Standards and Technology or other equivalent organization,” but does not give
information concerning where these materials can be found. The agency should consider adding further
information to the rule to ensure that those regulated by these rules can
readily access these materials.
Minn. R.
4740.2050, subp. 6, item C (page 16, lines 17-20)
The Administrative Law Judge proposes the following
change to this language regarding laboratory inspections: “When the commissioner determines after
inspection that a certified laboratory does not comply with applicable
provisions of parts 4740.2010 to 4740.2120, the commissioner shall notify the
laboratory of the deficiencies in writing.” This recommended change provides
clarification to the laboratories that any deficiencies found during an
inspection by the Department will be provided to the laboratory in writing and
not merely orally.
Minn. R.
4740.2050, subp. 6, item E (page 17, lines 10-12)
The Administrative Law Judge proposes the following
change to this language regarding laboratory inspections: “With the its new application,
the laboratory must submit written documentation of the steps taken to correct
the deficiencies with its new application.” This recommended change merely corrects a redundancy
in the proposed rules.
Minn. R.
4740.2050, subp. 10, item A (page 21, lines 5-7)
The Administrative Law Judge proposes
the following change to the language regarding revocation of laboratory
certification: “A laboratory’s certification may be revoked in total or in
part through written notification by the commissioner. When the commissioner determines that there
are grounds for partial or total revocation of a laboratory certification, the
commissioner shall notify the laboratory in writing. The laboratory shall retain certification . .
. .” The proposed language parallels the
suspension language in subpart 9, thereby providing greater clarity and
consistency across the rules, and eliminates ambiguity about the Commissioner’s
discretion in revoking certification.
Minn. R.
4740.2050, subp. 14, item A (page 26, lines 18-22)
The Administrative Law Judge proposes
the following change to the language regarding voluntary withdrawal of
certification by laboratories: “A
laboratory may choose to withdraw its application for certification or its
current certification in total or in part before the expiration date by
notifying the commissioner in writing and specifying the effective date of
withdrawal. If a laboratory
chooses to withdraw its application for certification or its current
certification in total or in part, the laboratory shall notify the commissioner
in writing and specify the effective date of withdrawal.” The proposed language would clarify the rule
by eliminating some ambiguity about the process of voluntary withdrawal and
whether or not a laboratory seeking to withdraw its certification is required
to accomplish withdrawal in writing with an effective date.
Minn. R.
4740.2060, subp. 2, item A and subp. 3, item A (page 30, lines 9 and 26)
It is recommended that the agency consider adding website
addresses for these Code of Federal Regulations citations. Such amendments would create consistency
across each of the subparts in 4740.2060 and provide greater ease of access to
the federal regulations for the readers of the rule.
Minn. R.
4740.2087, subp. 2, item D (4) (page 49, lines 13-14)
The Administrative Law Judge recommends that the
Department consider revising these two rule parts (as well as any other
references to signatures that are contained in this set of rules) to make it
clear whether the Department will in all circumstances accept electronic
signatures on documents filed by the laboratories. This will clarify the agency’s intent and
result in additional consistency in the rules.
Minn. R.
4740.2091, subp. 3, item F (page 55, line 4)
The Administrative Law Judge proposes the following minor
change to this language regarding frequency of calibration equipment: “. . . all thermometers must be calibrated on
an annual basis against an a NIST thermometer.” This recommended change merely corrects a
grammatical error.
Minn. R.
4740.2120, subp. 10, item B (page 94, line 6)
The agency
may wish to change this language to state that “background radiation
measurement values are must be subtracted from the total measured
activity in the determination of the sample activity.” This recommended change would parallel the
language used in the other items contained in this subpart of the proposed
rule.
B.L.N.
[1]
Minnesota Rules part 1400.2100.
[2] To be constitutional, a rule must be sufficiently
specific to provide fair warning of the type of conduct to which the rule
applies. Cullen v.
[3]
See
[4] Minn. Stat. § 14.055, subd. 5.