Current through Register Vol. 47, No. 6, September 18, 2024
(1)
Definition. For purposes of this chapter, "a waiver " means
action by the department that suspends, in whole or in part, the requirements
or provisions of a rule as applied to an identified person on the basis of the
particular circumstances of that person.
(2)Scope. This rule outlines
generally applicable standards and a uniform process for the granting of an
individual waiver from a rule adopted by the department in situations where no
other more specifically applicable law provides for a waiver. To the extent
another more specific provision of law governs the issuance of a waiver from a
particular rule, the more specific provision shall supersede this rule with
respect to any waiver from that rule.
(3)Applicability. The
department may only grant a waiver from a rule if the department has
jurisdiction over the rule and the requested waiver is consistent with
applicable statutes, constitutional provisions, or other provisions of law. The
department may not waive requirements created or duties imposed by
statute.
(4)Criteria for
waiver. In response to a petition completed pursuant to subrule
178.1(6), the department may in its sole discretion issue an order waiving in
whole or in part the requirements of a rule if the department finds, based on
clear and convincing evidence, all of the following:
a. The application of the rule would impose
an undue hardship on the person for whom the waiver is requested;
b. The waiver from the requirements of the
rule in the specific case would not prejudice the substantial legal rights of
any person;
c. The provisions of
the rule subject to the petition for a waiver are not specifically mandated by
statute or another provision of law; and
d. Substantially equal protection of public
health, safety, and welfare will be afforded by a means other than that
prescribed in the particular rule for which the waiver is requested.
(5)Filing of
petition. A petition for a waiver must be submitted in writing to the
department as follows:
a. Application for
license, registration, certification, or permit. If the petition relates to an
application for license, registration, certification, or permit, the petition
shall be made in accordance with the filing requirements for the application in
question.
b. Contested cases. If
the petition relates to a pending contested case, the petition shall be filed
in the contested case proceeding, using the caption of the contested
case.
c. Other. If the petition
does not relate to an application or a pending contested case, the petition may
be submitted to the department director.
d. A petition is deemed filed when it is
received at the department's office. A petition should be sent to the
Department of Public Health, Lucas State Office Building, 321 E. 12th Street,
Des Moines, Iowa 50319. The petition must be typewritten or legibly handwritten
in ink and substantially conform to the form specified in
641-178.2 (17A,135).
(6)Content of
petition. A petition for waiver shall include the following
information where applicable and known to the requester:
a. The name, address, and telephone number of
the person for whom a waiver is being requested and a reference to any related
contested case. The petition shall also include the name, address, and
telephone number of the petitioner's legal representative, if applicable, and a
statement indicating the person to whom communications concerning the petition
should be directed.
b. A
description and citation of the specific rule from which a waiver is
requested.
c. The specific waiver
requested, including the precise scope and duration.
d. The relevant facts that the petitioner
believes would justify a waiver under each of the four criteria described in
subrule 178.1(4). This statement shall include a signed statement from the
petitioner attesting to the accuracy of the facts provided in the petition and
a statement of reasons that the petitioner believes will justify a
waiver.
e. A history of any prior
contacts between the department and the petitioner relating to the regulated
activity, license, registration, certification, or permit affected by the
proposed waiver, including a description of each affected license,
registration, certification, or permit held by the requester, any formal
charges filed, any notices of violation, contested case hearings, or
investigations relating to the regulated activity, license, registration,
certification or permit.
f. Any
information known to the requester regarding the department's action in similar
circumstances.
g. The name,
address, and telephone number of any public agency or political subdivision
that also regulates the activity in question or that might be affected by the
granting of a waiver.
h. The name,
address, and telephone number of any person who would be adversely affected by
the granting of the petition.
i.
The name, address, and telephone number of any person with knowledge of the
relevant facts relating to the proposed waiver.
j. Signed releases of information authorizing
persons with knowledge regarding the request to furnish the department with
information relevant to the waiver.
(7)
Additional information.
Prior to issuing an order granting or denying a waiver, the department may
request additional information from the petitioner relative to the petition and
surrounding circumstances. If the petition was not filed in a contested case,
the department may, on its own motion or at the petitioner's request, schedule
a telephonic or in-person meeting between the petitioner and the department
director or the director's designee.
(8)
Notice. The department
shall acknowledge a petition upon receipt. Except where otherwise provided by
law, every petition shall be served by the petitioner upon each of the parties
of record of the proceeding and on all other persons identified in the petition
for waiver as affected by the petition, simultaneously with the filing. The
petitioner shall serve the notice on all persons to whom notice is required by
any provision of law and provide a written statement to the department
attesting that notice has been provided. In addition, the department may give
notice to other persons.
(9)
Hearing procedures. The provisions of Iowa Code sections
17A.10
to
17A.18A
regarding contested case hearings shall apply to any petition for a waiver
filed within a contested case. A person who objects to a denial of a waiver in
proceedings other than a contested case hearing may make an informal appearance
before the department director, or the director's designee, to request
reconsideration.
(10)
Ruling. An order granting or denying a waiver shall be in
writing and shall contain a reference to the particular person and rule or
portion thereof to which the order pertains, a statement of the relevant facts
and reasons upon which the action is based, and a description of the precise
scope and duration of the waiver if one is issued.
a.
Department discretion.
The final decision on whether the circumstances justify the granting of a
waiver shall be made at the sole discretion of the department upon
consideration of all relevant factors. Each petition for a waiver shall be
evaluated by the department based on the unique, individual circumstances set
out in the petition.
b.
Burden of persuasion. The burden of persuasion rests with the
petitioner to demonstrate by clear and convincing evidence that the department
should exercise its discretion to grant a waiver from a department
rule.
c.
Narrowly tailored
exception. A waiver, if granted, shall provide the narrowest exception
possible to the provisions of a rule.
d.
Administrative deadlines.
When the rule from which a waiver is sought establishes administrative
deadlines, the department shall balance the special individual circumstances of
the petitioner with the overall goal of uniform treatment of all similarly
situated persons.
e.
Conditions. The department may place any condition on a waiver
that the department finds desirable to protect the public health, safety, and
welfare.
f.
lime period of
waiver. A waiver shall not be permanent unless the petitioner can show
that a temporary waiver would be impracticable. If a temporary waiver is
granted, there is no automatic right to renewal. At the sole discretion of the
department, a waiver may be renewed if the department finds that grounds for a
waiver continue to exist.
g.
Time for ruling. The department shall grant or deny a petition
for a waiver as soon as practicable but, in any event, shall do so within 120
days of its receipt unless the petitioner agrees to a later date.
However, if a petition is filed in a contested case, the
department shall grant or deny the petition no later than the time at which the
final decision in that contested case is issued.
h.
When deemed denied.
Failure of the department to grant or deny a petition within the required time
period shall be deemed a denial of that petition by the department. However,
the department shall remain responsible for issuing an order denying a
waiver.
i.
Service of
order. Within seven days of its issuance, any order issued under this
rule shall be transmitted to the petitioner or the person to whom the order
pertains and to any other person entitled to such notice by any provision of
law.
(11)
Public
availability. All orders granting or denying a waiver petition shall
be indexed, filed, and available for public inspection as provided in Iowa Code
section
17A.3.
Petitions for a waiver and orders granting or denying a waiver petition are
public records under Iowa Code chapter 22. Some petitions or orders may contain
information the department is authorized or required to keep confidential. The
department may accordingly redact confidential information from petitions or
orders prior to public inspection.
(12)
Summary reports. When
the department grants a waiver, the department shall submit to the designated
Internet site, within 60 days of the waiver decision, the following
information: identification of the rules for which a waiver has been granted or
denied, the number of times a waiver was granted or denied for each rule, a
citation to the statutory provisions implemented by these rules, and a general
summary of the reasons justifying the department's actions on waiver requests.
If practicable, the report shall include information detailing the extent to
which the granting of a waiver has affected the general applicability of the
rule itself.
(13)
Cancellation of a waiver. A waiver issued by the department
pursuant to this rule may be withdrawn, canceled, or modified if, after
appropriate notice and hearing, the department issues an order finding any of
the following:
a. The petitioner or the person
who was the subject of the waiver order withheld or misrepresented material
facts relevant to the propriety or desirability of the waiver; or
b. The alternative means for ensuring that
the public health, safety and welfare will be adequately protected after
issuance of the waiver order have been insufficient; or
c. The subject of the waiver order has failed
to comply with all conditions contained in the order.
(14)
Violations. A violation
of a condition in a waiver order shall be treated as a violation of the
particular rule for which the waiver was granted. As a result, the recipient of
a waiver under this rule who violates a condition of the waiver may be subject
to the same remedies or penalties as a person who violates the rule at issue.
(15)
Defense.
After the department issues an order granting a waiver, the order is a defense
within its terms and the specific facts indicated therein only for the person
to whom the order pertains in any proceeding in which the rule in question is
sought to be invoked.
(16)
Judicial review. Judicial review of the department's decision
to grant or deny a waiver petition may be taken in accordance with Iowa Code
chapter 17A.
