Title 11
DEPARTMENT OF TRANSPORTATION
Subtitle 01 OFFICE OF THE
SECRETARY
Notice of Availability of
Evaluation Report
Pursuant to
Executive Order 01.01.2003.20, Implementation of the Regulatory Review and
Evaluation Act, notice is hereby given that the Evaluation Report concerning
COMAR Title11, Subtitle 01, Office of the Secretary, is available for public
inspection and comment for a period of 60 days following the date of this
notice.
This report may be
reviewed by appointment at the Office of the Secretary, 7201 Corporate Center
Drive, Hanover, MD 21076. Information and appointments may be obtained by
contacting Stephanie Ford, Regulations Manager, at 410-865-1154 or by email at sford1@mdot.maryland.gov.
[24-05-16]
Subtitle 03 MARYLAND AVIATION
ADMINISTRATION
Notice
of Availability of Evaluation Reports
Pursuant to State
Government Article §10-135(b)(1), Implementation of the Regulatory Review and
Evaluation Act, notice is hereby given that the Evaluation Reports regarding
COMAR 11.03.01 through 11.03.09 are available for public inspection and comment
for a period of 60 days following the date of this notice.
These reports may
be reviewed at the Office of Administrative Services, Division of
Administration and Performance Management, Maryland Aviation Administration,
7001 Aviation Blvd., Room 123, Glen Burnie, MD 21061, Monday through Friday, 8
a.m. to 4:30 p.m., except weekends and State holidays.
Information may be
obtained by contacting Stacey L. Hicks-Johnson at (410) 859-7351 or by email at
shicks-johnson@bwiairport.com
.
[24-05-15]
Final Action on Regulations
Symbol Key
• Roman type
indicates text already existing at the time of the proposed action.
• Italic
type indicates new text added
at the time of proposed action.
• Single underline, italic indicates new text added at the time of final
action.
• Single
underline, roman indicates existing text added at the time of final action.
• [[Double
brackets]] indicate text deleted at the time of final action.
Title 09
MARYLAND DEPARTMENT OF LABOR
Subtitle 09 MARYLAND BOARD OF
ELECTRICIANS
09.09.01 Fees and Deadlines
Authority: Business Occupations and Professions Article, §§6-205,
6-207,
6-310(c)(2), 6-311(a)(2), (b)(1), (d)(3)(iii), (d)(4)(ii), and (f)(3), and
6-313(c)—(e); Business Regulation Article, §§2.106.2 and 2-106.9,
Annotated Code of Maryland
Notice of Final Action
[23-310-F]
On February 27, 2024, the State Board of Electricians adopted
amendments to Regulation .03 under COMAR 09.09.01 Fees and Deadlines.
This action, which was proposed for adoption in 51:1 Md. R. 32—33 (January 12,
2024), has been adopted as proposed.
Effective Date: March 18, 2024.
CHET BROWN
Chair
State Board of Electricians
Subtitle 15 STATE BOARD OF HEATING,
VENTILATION, AIR-CONDITIONING, AND REFRIGERATION CONTRACTORS
09.15.01 Fees
Authority: Business Regulation Article, §§2-106.2, 2-106.9,
9A-205(a)(1), and 9A-207, Annotated Code of Maryland
Notice of Final Action
[23-274-F]
On February 14, 2024, the State Board of Heating, Ventilation,
Air-Conditioning, and Refrigeration Contractors adopted amendments to
Regulation .03 under COMAR 09.15.01 Fees. This action, which was
proposed for adoption in 50:25 Md. R. 1094—1095 (December 15, 2023), has been
adopted as proposed.
Effective Date: March 18, 2024.
MICHAEL GIANGRANDI
Chair
State Board of Heating, Ventilation, Air-Conditioning,
and Refrigeration Contractors
Title 10
MARYLAND DEPARTMENT OF HEALTH
Subtitle 24 MARYLAND HEALTH CARE
COMMISSION
10.24.10 State Health Plan for
Facilities and Services: Acute Care Hospital Services
Authority: Health-General Article, §§19-109(a)(1) and (3),
19-118, 19-120, and 19-126, et seq., Annotated Code of Maryland
Notice of Final Action
[23-250-F-I]
On February 22, 2024, the Maryland Health Care Commission adopted
the repeal of existing Regulation .01 and new Regulation .01
under COMAR 10.24.10 State Health Plan for Facilities and Services: Acute
Care Hospital Services. This action, which was proposed for adoption in
50:24 Md. R. 1050—1051 (December 1, 2023), has been adopted as proposed.
Effective Date: March 18, 2024.
RANDOLPH S. SERGENT, ESQ.
Chair
Title 13A
STATE BOARD OF EDUCATION
Subtitle 07 SCHOOL PERSONNEL
13A.07.06 Programs for
Professionally Licensed Personnel
Authority: Education Article, §§1-303(2)(ii) and (iii), 2-205,
6-120, 6-121,
6-126, 6-704, and 11-208, Annotated Code of Maryland
Notice of Final Action
[23-075-F-I]
On October 12, 2023, the Professional Standards and Teacher
Education Board adopted the repeal of existing Regulation .01 under existing COMAR 13A.07.06 Programs for
Professionally Certified Personnel and new Regulations .01—.15
under COMAR 13A.07.06 Programs for Professionally Licensed Personnel.
This action, which was proposed for adoption in 50:14 Md. R. 621—633 (July 14,
2023), has been adopted with the nonsubstantive changes shown below.
Effective Date: April 1, 2024.
Attorney General’s Certification
In
accordance with State Government Article, §10-113, Annotated Code of Maryland,
the Attorney General certifies that the following changes do not differ
substantively from the proposed text. The nature of the changes and the basis
for this conclusion are as follows:
On July 14, 2023, the Professional Standards and Teacher Education
Board (PSTEB) published amendments to COMAR 13A.12 for public comment. After
public comment, PSTEB and the Maryland State Department of Education (MSDE)
agreed to make nonsubstantive changes to the proposed regulation. The
amendments proposed by MSDE, PSTEB, and the State Board of Education do not
change the position of any group affected by the regulation, decrease any
benefits, or increase administrative burdens, nor do these changes substantially
affect the rights, duties, and obligations of Maryland’s teachers and the
public.
Regulation .02B(8): The definition for “clinical mentor” was
removed because the term does appear in the regulation. This change could
reasonably have been anticipated by participants in rulemaking, as much of this
definition is duplicative of COMAR 13A.07.06.09B. This amendment would not
change the position of any group affected by the regulation, decrease any
benefits, or increase administrative burdens.
Regulation .12B(9), (11): This regulation sets forth the general
teacher preparation competencies to determine readiness to enter the profession
for teacher candidates across all content areas and grade levels. Among these
competencies, the regulation requires teachers to apply instructional supports
and use assistive technologies to support students with “exceptionalities”.
However, “exceptionalities” is an incorrect term in the context of IEPs, 504
plans, and assistive technology, which are only associated with individuals
with “disabilities”. Thus, the agency seeks to replace the incorrect term
“exceptionalities” with the correct term “disabilities” in .12B(9) and (11).
The agency has advised that this rewording for the sake of clarity would not
change application of the regulation. This change could have been reasonably
anticipated by participants in rulemaking and does not change the position of
any group affected by the regulation, decrease any benefits, or increase
administrative burdens.
Regulation .13B(3)(b): This regulation contains the required
literacy competencies each teacher candidate must demonstrate. For teacher
candidates seeking licensure in Early Childhood, Elementary, Special Education,
and English to Speakers of Other Languages, these candidates are required to
identify and implement an appropriate reading screener. However, the reading
screener is not a diagnostic assessment tool and cannot be used to identify
skill gaps. Instead, it is used to identify students at risk for having skill
gaps. Accordingly, the agency seeks to replace the phrase “determine skill
gaps” with “identify students at risk for reading difficulties”. This is a
rewording for the sake of clarity that could have been reasonably anticipated
by participants in rulemaking. This amendment would not change the position of
any group affected by the regulation, decrease any benefits, or increase
administrative burdens.
Regulation .14C(5): This regulation states the required math
competencies each teacher candidate must demonstrate. Among the pedagogical
skills that must be demonstrated, teacher candidates must integrate
instructional strategies and teaching aids to enhance student learning. These
teaching aids include multiple representations, manipulatives, calculators, and
other technological aids. The agency seeks to amend “teaching aides” to
“teaching aids” and “technological aides” to “technological aids”. This change
in spelling for the sake of clarity could have been reasonably anticipated by
participants in rulemaking and does not change the position of any group
affected by the regulation, decrease any benefits, or increase administrative
burdens.
.02 Definitions.
A. (proposed text unchanged)
B. Terms Defined.
(1)—(7) (proposed text unchanged)
[[(8) “Clinical mentor” means a highly
competent teacher, trained and selected by the partner school, who will work to
instill in the participant the skills, attitudes, values, and knowledge
necessary for the next generation of teachers.]]
[[(9)]] (8) — [[(27)]] (26) (proposed text unchanged)
.12 Teacher Preparation
Competencies: General Competencies.
A. (proposed text unchanged)
B. Required General
Competencies. The teacher candidate shall:
(1)—(8) (proposed text unchanged)
(9) Apply instructional
supports, including a 504 Plan and an individualized education plan, to support
a student with [[exceptionalities]] disabilities by providing developmentally appropriate access to
age-level or grade-level instruction, individually and in collaboration with
colleagues;
(10) (proposed text unchanged)
(11) Use assistive
technologies ranging from low-tech to high-tech devices or equipment,
materials, and resources to educate individuals whose [[exceptionalities]] disabilities interfere with written
or verbal communication;
(12)—(15) (proposed text unchanged)
.13 Teacher Preparation
Competencies: Literacy Competencies.
A. (proposed text unchanged)
B. Literacy Competencies for
Early Childhood, Elementary, Special Education, and English to Speakers of
Other Languages. Teacher candidates completing programs that lead to licensure
in early childhood, elementary, English to speakers of other languages, and
special education areas shall demonstrate an understanding of the following:
(1)—(2) (proposed text unchanged)
(3) Effective Literacy
Assessment. The teacher candidate shall:
(a) (proposed text unchanged)
(b) Identify and implement a
developmentally appropriate reading screener to [[determine skill gaps]] identify students at risk for reading difficulties;
(c) (proposed text unchanged)
(4) (proposed text unchanged)
.14 Teacher Preparation
Competencies: Math Competencies.
A.—B. (proposed text unchanged)
C. Pedagogical Skills. The
teacher candidate shall:
(1)—(4) (proposed text unchanged)
(5) Integrate instructional
strategies and teaching [[aides]] aids that
enhance the learning of mathematics, such as multiple representations,
manipulatives, calculators, and other technological [[aides]] aids; and
(6) (proposed text unchanged)
D.—E. (proposed text unchanged)
CAREY M.
WRIGHT, Ed.D.
Interim State Superintendent of Schools
Notice of Final Action
[23-074-F]
On October 12, 2023, the Professional Standards and Teacher
Education Board adopted the repeal of the following existing regulations under
existing Subtitle 12 Certification:
(1) Regulations .01—.14
under COMAR 13A.12.01 General Provisions;
(2) Regulations .01—.29
under COMAR 13A.12.02 Teachers;
(3) Regulations .01—.12
under COMAR 13A.12.03 Specialists;
(4) Regulations .01—.16
under COMAR 13A.12.04 Administrators and Supervisors;
(5) Regulations .01—.08 under
COMAR 13A.12.05 Suspensions
and Revocations; and
(6) Regulations .01—.08
under COMAR 13A.12.06 Professional Standards and Teacher Education Board.
At the same time, the Professional Standards and Teacher Education
Board also adopted the following new regulations under new Subtitle 12 Educator Licensure:
(1) Regulations .01—.06
under COMAR 13A.12.01 General
Provisions;
(2) Regulations .01—.08
under COMAR 13A.12.02 Teachers;
(3) Regulations .01—.05
under COMAR 13A.12.03 Professional and
Technical Education and Specialized Areas for Fine Arts;
(4) Regulations .01—.15
under COMAR 13A.12.04 Specialists;
(5) Regulations .01—.15
under COMAR 13A.12.05 Administrators and Supervisors;
(6) Regulations .01—.09
under COMAR 13A.12.06 Disciplinary Actions and Denials; and
(7) Regulations .01—.08
under COMAR 13A.12.05 Professional Standards and Teacher Education Board.
This action, which was proposed for adoption in 50:14 Md. R.
633—658 (July 14, 2023), has been adopted with the nonsubstantive changes shown
below.
Effective Date: April 1, 2024.
Attorney General’s Certification
In
accordance with State Government Article, §10-113, Annotated Code of Maryland,
the Attorney General certifies that the following changes do not differ
substantively from the proposed text. The nature of the changes and the basis
for this conclusion are as follows:
On July 14, 2023, the Professional Standards and Teacher Education
Board (PSTEB) published amendments to COMAR 13A.12 for public comment. After
public comment, PSTEB and the Maryland State Department of Education (MSDE)
agreed to make ten nonsubstantive changes to the proposed regulation. The
amendments proposed by MSDE, PSTEB, and the State Board of Education do not
change the position of any group affected by the regulations, decrease any
benefits, or increase administrative burdens, nor do these changes substantially
affect the rights, duties, and obligations of Maryland’s teachers and the
public.
COMAR 13A.12.01.02B(30): The definition for “long term substitute
experience” was removed because the term does not appear in the regulation.
This change could reasonably have been anticipated by participants in
rulemaking, given that the term is not used in the regulation. The change does
not alter the position of any group affected by the regulation, decrease any
benefits, or increase administrative burdens. Failure to remove the term could
cause confusion for readers of the regulation.
COMAR 13A.12.01.02B(38): The definition for “performance review
program” was removed because the term does not appear in the regulation. Like
the previous change, the removal of this definition for a term that does not
appear in the regulation could reasonably have been anticipated by participants
in rulemaking. The change does not alter the position of any group affected by
the regulation, decrease any benefits, or increase administrative burdens.
Failure to remove the term could cause confusion for readers of the regulation
searching for the term.
COMAR 13A.12.01.04C(4): This regulation outlines the different
types of educator licenses. Specialists, as regulated under COMAR 13A.12.04.02,
were added in the regulation listing temporary professional licenses because
they had been inadvertently omitted from this listing. This clarifying change
could have been reasonably anticipated by participants in rulemaking to conform
with COMAR 13A.12.04.02A(1), which makes clear that specialists are eligible
for a temporary professional license. Failure to correct this omission risks
confusing readers as to whether specialists are eligible for a temporary
professional license. The change does not alter the position of any group
affected by the regulation, decrease any benefits, or increase administrative
burdens.
COMAR 13A.12.01.05C(1): This regulation references two distinct
paths to licensure, either of which is required. Either the educator can meet
the general requirements in COMAR 13A.12.01.05A or the exemption in .05B.
However, the regulation incorrectly uses “and” instead of “or” when explaining
these distinct paths to licensure. This clarifying change from “and” to “or”
could have been reasonably anticipated by participants in rulemaking to
accurately describe the paths to licensure. Failure to correct this error will
confuse readers by suggesting that both the general requirements and the
exemption to these requirements are necessary for reinstatement for licensure.
The change does not alter the position of any group affected by the regulation,
decrease any benefits, or increase administrative burdens.
COMAR 13A.12.01.05C(2): This is identical to the change proposed
in COMAR 13A.12.01.05C(1). The agency seeks a clarifying change from “and” to
“or” in describing the separate paths to licensure. Failure to correct this
error will confuse readers regarding necessary requirement for licensure
reinstatement. The change does not alter the position of any group affected by
the regulation, decrease any benefits, or increase administrative burdens.
COMAR 13A.12.01.05C(3): This is identical to the changes proposed
in COMAR 13A.12.01.05C(1) and (2). The agency seeks a clarifying change from
“and” to “or” in describing the separate paths to licensure. Failure to correct
this error will confuse readers regarding necessary requirement for licensure
reinstatement. The change does not alter the position of any group affected by
the regulation, decrease any benefits, or increase administrative burdens.
COMAR 13A.12.02.06B: This regulation explains the specific
requirements for the 90 Professional Development Points (PDPs) necessary for
educators applying for licensure renewal. The language of the specific
requirements was changed from “to include” to “that shall include”. This is a
simple clarifying change that could have been reasonably anticipated by
participants in rulemaking and does not alter the position of any group
affected by the regulation, decrease any benefits, or increase administrative burdens.
COMAR 13A.12.03.05B: This is identical to the change proposed in
COMAR 13A.12.02.06B, changing the language of the specific requirements for the
90 PDPs from “to include” to “that shall include”. This simple clarifying
change could have been reasonably anticipated by participants in rulemaking and
does not alter the position of any group affected by the regulation, decrease
any benefits, or increase administrative burdens.
COMAR 13A.12.04.04B(5)(a): This regulation explains the pathways
to licensure for Library Media Specialists. COMAR 13A.12.04.04B(5) specifically
regulates the requirements for applicants pursuing the pathway equivalent to a
master’s degree. In listing these requirements, Regulation .04B(5)(a)
mistakenly referenced its own subsection for required content coursework
instead of .04B(5)(b)—the very next subsection of the regulation—which lists
the content coursework required for this pathway. This clarifying change is
necessary to accurately reference the correct subsection within this
regulation. Correction of this error could have been reasonably anticipated by
participants in rulemaking. The change does not alter the position of any group
affected by the regulation, decrease any benefits, or increase administrative
burdens.
COMAR 13A.12.04.15B: This is identical to the changes proposed in
COMAR 13A.12.02.06B and .03.05B, changing the language of the specific
requirements for the 90 PDPs from “to include” to “that shall include”. This
clarifying change could have been reasonably anticipated by participants in
rulemaking and does not alter the position of any group affected by the
regulation, decrease any benefits, or increase administrative burdens.
COMAR 13A.12.05.15B: Again, this is identical to the changes
proposed in COMAR 13A.12.02.06B, .03.05B, and .04.15B. The agency seeks to
clarify the language of the specific requirements for the 90 PDPs from “to
include” to “that shall include”. This clarification could have been reasonably
anticipated by participants in rulemaking and does not alter the position of
any group affected by the regulation, decrease any benefits, or increase
administrative burdens.
Subtitle 12 EDUCATOR
LICENSURE
13A.12.01 General Provisions
Authority: Education Article,
§§2-205, 2-303(g), [[and]] 6-127, [[and]]
6-701—6-708, and 8-3A-03[[, and]]; Family Law,
§10-119.3[[,]]; Annotated
Code of Maryland
.02
Definitions.
A. (proposed text
unchanged)
B. Terms Defined.
(1)—(29) (proposed text
unchanged)
[[(30) “Long-term
substitute experience” means full-time, continuous substitute teaching service
in the same classroom for not less than 3 months.]]
[[(31)]] (30) — [[(37)]] (36) (proposed text unchanged)
[[(38) “Performance
Review Program” means the scheduled review of educator performance and
provision of supports to ensure quality of teaching.]]
[[(39)]] (37) — [[(52)]] (50) (proposed text unchanged)
.04 Issuance and Types of Licenses.
A.—B. (proposed text
unchanged)
C. Types of Educator
Licenses.
(1)—(3) (proposed text unchanged)
(4) Temporary Professional
License. The Temporary Professional License is a nonrenewable license valid for
a period not to exceed 2 years and issued only for licenses under COMAR
13A.12.02.02 [[and]],
13A.12.03.02, and 13A.12.04.02.
(5)—(9) (proposed text unchanged)
D.—G. (proposed text unchanged)
.05
Reinstatement of an Expired Professional License.
A.—B. (proposed text
unchanged)
C. Historic Professional Certificate or License.
(1) The Department shall issue an Initial Professional License to an
educator who holds an expired Maryland Professional Eligibility Certificate or
Standard Professional I Certificate and meets the requirements to reinstate a
Maryland license under [[§§A and]] §A or B of
this regulation.
(2) The Department shall issue a Professional License to an educator
who holds an expired Maryland Standard Professional II Certificate and meets
the requirements to reinstate a Maryland license under [[§§A and]] §A or B of this regulation.
(3) The Department shall issue an Advanced Professional License to an
educator who holds an expired Maryland Advanced Professional Certificate and
meets the requirements to reinstate a Maryland license under [[§§A and]] §A or B of this regulation.
(4) (proposed text
unchanged)
13A.12.02 Teachers
Authority: Education Article,
§§2-205, 2-303(g), 6-701—6-708, 8-3A-03, and 8-701—8-708, Annotated Code of
Maryland
.06 Professional Development
Points.
A. (proposed text unchanged)
B. Educators applying to
renew an Initial Professional, Professional, or Advanced Professional License
shall complete a minimum of 90 PDPs [[to]] that shall include:
(1)—(4) (proposed text unchanged)
C.—F. (proposed text unchanged)
13A.12.03 Professional and
Technical Education and Specialized Areas for Fine Arts
Authority: Education Article,
§§2-205, 2-303(g), 6-701—6-708, 8-3A-03, and 8-701—8-708, Annotated Code of
Maryland
.05 Professional Development
Points — Professional and Technical Education/Specialized Areas for Fine Arts.
A. (proposed text unchanged)
B. Educators applying to
renew an Initial Professional, Professional, or Advanced Professional License
shall complete a minimum of 90 PDPs [[to]] that shall include:
(1)—(4) (proposed text unchanged)
C.—E. (proposed text unchanged)
13A.12.04 Specialists
Authority: Education Article,
§§2-205, 2-303(g), 6-701—6-708, 8-3A-03, and 8-701—8-708, Annotated Code of
Maryland
.04 Library Media Specialist.
A. (proposed text unchanged)
B. Pathways to Licensure. To
qualify for a Professional Specialist License, a candidate shall complete one
of the following pathways:
(1)—(4) (proposed text unchanged)
(5) Master’s Equivalent.
(a) The applicant shall have
a bachelor’s degree or higher from an institution of higher education, to
include a program of 36 semester hours of post-baccalaureate credit with 15
semester hours completed at one institution and a minimum of 24 semester hours
of graduate credit in the content coursework listed in [[§B(5)(a)]] §B(5)(b) of this regulation.
(b)—(e) (proposed text unchanged)
C. (proposed text unchanged)
.15 Professional Development
Points.
A. (proposed text unchanged)
B. Educators applying to
renew an Initial Professional, Professional, or Advanced Professional License
shall complete a minimum of 90 PDPs [[to]] that shall include:
(1)—(4) (proposed text unchanged)
C.—E. (proposed text unchanged)
13A.12.05 Administrators and
Supervisors
Authority: Education Article,
§§2-205, 2-303(g), 6-701—6-708, 8-3A-03, and 8-701—8-708, Annotated Code of
Maryland
.15 Professional Development
Points.
A. (proposed text unchanged)
B. Educators applying to
renew an Initial Professional, Professional, or Advanced Professional License
shall complete a minimum of 90 PDPs [[to]] that shall include:
(1)—(4) (proposed text unchanged)
C.—E. (proposed text unchanged)
CAREY M. WRIGHT, Ed.D.
Interim State Superintendent of Schools
Title 26
DEPARTMENT OF ENVIRONMENT
Subtitle 30 MARINE CONTRACTORS
LICENSING BOARD
Notice of Final Action
[23-239-F]
On February 28, 2024, the Secretary of the Environment adopted the
following regulations under a new subtitle, Subtitle 30 Marine Contractors Licensing Board:
(1) New Regulations .01—.08
under a new chapter, COMAR 26.30.01 General Regulations;
(2) New Regulations .01—.09
under a new chapter, COMAR 26.30.02 Licensing Procedures and Fees;
(3) New Regulations .01—.03
under a new chapter, COMAR 26.30.03 Continuing Education; and
(4) New Regulations .01
and .02 under a new chapter, COMAR 26.30.04 Disciplinary
Action.
This action, which was proposed for adoption in 51:1 Md. R. 52—57
(January 12, 2024), has been adopted with the nonsubstantive changes shown
below.
Effective Date: March 18, 2024.
Attorney General’s Certification
In
accordance with State Government Article, §10-113, Annotated Code of Maryland,
the Attorney General certifies that the following changes do not differ
substantively from the proposed text. The nature of the changes and the basis
for this conclusion are as follows:
A change has been made to a subsection heading, from “Incidental
Marine Construction” to “Incidental Marine Contractor Services”. This
subsection heading more accurately aligns with the activities described in this
subsection, which are not limited to construction. The improved subsection
heading does not change the activities covered by the license category at
issue.
26.30.01 General Regulations
Authority: Environment
Article, Title 17, Subtitles 1—5, Annotated Code of Maryland
.05 License Categories.
A. (proposed text unchanged)
B. License Categories.
(1)—(3) (proposed text unchanged)
(4) Category 4: Incidental Marine [[Construction]]
Contractor Services. This license category is suitable for contractors
who perform, or solicit to perform, the following marine contractor services:
directional boring, aquaculture, submerged aquatic vegetation and wetland grass
planting, and any other related marine contractor services, as approved by the
Board.
SERENA
McILWAIN
Secretary of the Environment
Title 30
MARYLAND INSTITUTE FOR EMERGENCY MEDICAL SERVICES SYSTEMS (MIEMSS)
Subtitle 01 GENERAL
30.01.02 Documents
Incorporated by Reference
Authority: Education Article, §§13-509 and 13-516, Annotated Code
of Maryland
Notice of Final Action
[23-255-F-I]
On February 13, 2024, the Maryland State Emergency Medical
Services Board adopted amendments to Regulation .01 under COMAR
30.01.02 Documents Incorporated by Reference. This action, which was
proposed for adoption in 50:24 Md. R. 1064 (December 1, 2023), has been adopted
as proposed.
Effective Date: March 18, 2024.
THEODORE R. DELBRIDGE, M.D., M.P.H.
Executive Director
Proposed Action on Regulations
Title 10
MARYLAND DEPARTMENT OF HEALTH
Subtitle 15 FOOD
10.15.04 Food and Drink
Processing and Transportation
Authority: Health-General Article, §§18-102, 21-101, 21-102,
21-211,
21-234, 21-301, 21-304, 21-308, 21-309.1, 21-309.2, and 21-336, Annotated Code
of Maryland
Notice of Proposed Action
[23-323-P]
The Secretary of Health proposes to amend Regulations .01, .02, and .04, repeal
Regulations .05—.26, and adopt new
Regulations .05—.18 and .20—.23 under COMAR 10.15.04 Food and Drink Processing and Transportation.
Statement of Purpose
The purpose of this action is to revise COMAR 10.15.04 to update
the organization and terminology of the chapter for ease of use for industry,
staff, and the general public.
Revisions were also necessary to align with current practice and
national and federal guidelines, including some set forth in the FSMA. New
record-keeping requirements and risk-based preventive controls have been
implemented industry wide, and language has been added to outline these items.
Updated labeling regulations were required to include sesame, the ninth major
food allergen to be required on food labeling. Updated training and education
requirements for managers and employees were added to align with general
provisions required by current federal regulations.
The definition of “food processing plant” was adjusted to match
the terminology used for licensing categories and to exclude prepackaged
ready-to-eat snack foods that do not require temperature control for safety,
packaged ice, and food transfer stations where food is not stored. This aligns
with federal workloads and eliminates regulation of certain low-risk food
storage businesses. Modified requirements that apply to facilities solely
engaged in the storage of unexposed packaged foods were added to align with new
federal regulations. Inspection frequency has been updated to allow field
inspectors to spend more time at each inspection and align Maryland inspection
frequencies closer to national averages, which were found to be much less
frequent than current Maryland requirements.
Estimate of Economic Impact
The proposed action has no economic impact.
Economic Impact on Small Businesses
The proposed action has minimal or no economic impact on small
businesses.
Impact on Individuals with Disabilities
The proposed action has no impact on individuals with
disabilities.
Opportunity for Public Comment
Comments may be sent to Jourdan Green, Director, Office of
Regulation and Policy Coordination, Maryland Department of Health, 201 West
Preston Street, Room 512, Baltimore, MD 21201, or call 410-767-6499 (TTY
800-735-2258), or email to mdh.regs@maryland.gov. Comments will be accepted
through April 8, 2024. A public hearing has not been scheduled.
.01 Scope.
This chapter:
A. Provides the minimum food safety and sanitation requirements for
food processing plants, including warehouses and transfer stations, and the
transportation of food; and
[B. Establishes, along with COMAR 10.15.03, the standards of
the Maryland Department of Health’s part of a program jointly administered with
the Maryland Department of Agriculture under COMAR 15.04.01 and 15.11.11 to
control Salmonella Enteritidis in shell eggs and egg-producing chickens; and]
[C.] B. (text unchanged)
.02 Definitions.
A. (text unchanged)
B. Terms Defined.
(1) Adulterated Food.
(a) (text unchanged)
(b) “Adulterated food” includes food that [is]:
[(i) Spoiled;
(ii) Contaminated; or
(iii) Misbranded so that the food is unsafe for human consumption.]
(i) Is diseased;
(ii) Is contaminated;
(iii) Is filthy;
(iv) Is putrid;
(v) Has decomposed;
(vi) Contains any poisonous or otherwise deleterious substance
that, in the quantity present, reasonably would be expected to make it
injurious to health;
(vii) Contains any food additive or color additive, the
particular use of which has not been found safe as provided under
Health-General Article, §21-239, Annotated Code of Maryland;
(viii) Was produced, prepared, packed, or held under unsanitary
conditions that reasonably would be expected to have contaminated it with
filth;
(ix) Was produced, prepared, packed, or held under unsanitary
conditions that reasonably would be expected to have caused it to be diseased,
unwholesome, or injurious to health;
(x) Was packaged in a container composed of any poisonous or
otherwise deleterious substance that reasonably would be expected to have
caused the food to be injurious to health; or
(xi) Is misbranded so that the food is unsafe for human
consumption.
(2) “Allergen cross-contact” means the unintentional
incorporation of a food allergen into a food that has not been identified as
containing it.
[(2)] (3) (text unchanged)
[(3)] (4) “Approved source” means a source of
food or food ingredients accepted by the Department because the food or food
ingredients from the source:
(a) Are not adulterated foods or misbranded as defined in
§B(1) and [(19)] (21) of this regulation; and
(b) (text unchanged)
[(4)] (5) (text unchanged)
[(5) “Commercially sterile” means the condition achieved by
the:
(a) Application of heat, pressure, or other energy or matter that
renders the food free of:
(i) Microorganisms capable of reproducing in the food under normal
nonrefrigerated conditions of storage and distribution; and
(ii) Viable microorganisms, including spores, that cause disease;
or
(b) Control of water activity and the application of heat,
pressure, or other energy or matter that renders the food free of
microorganisms capable of reproducing in the food under normal nonrefrigerated
conditions of storage and distribution.]
(6) “Contamination” means[:
(a) Microbiological, chemical, radiological, or physical substances
that are capable of causing a food to be adulterated; or
(b) The result of adding the substances described in §B(5)(a) of
this regulation to a food or food contact surface.] the process or
state that potentially renders a food unsafe for human consumption due to the
adulteration of the food with:
(a) Pathogens;
(b) Chemicals;
(c) Allergens;
(d) Foreign objects; or
(e) Filth.
(7) “Corrective action” means the documented steps taken when a
deviation occurs at a control point to:
(a) Address the cause of the deviation;
(b) Restore control; and
(c) Prevent the affected food from entering commerce.
[(7)] (8) “Critical control point” means a [point
in the processing of food where there is a reasonable likelihood that improper
control may cause, allow, or contribute to a hazard to public health.] step
or procedure in a food process at which control can be applied, and is
essential to:
(a) Prevent a food safety hazard;
(b) Eliminate a food safety hazard; or
(c) Reduce a hazard to an acceptable level.
[(8) “Critical factor” means a property, characteristic,
condition, aspect, or other parameter, which, if varied, may affect a scheduled
process.]
(9) Critical Item.
(a) (text unchanged)
(b) “Critical item” includes the following requirements:
(i) (text unchanged)
(ii) Food is protected from contamination and [adulteration]
allergen cross-contact;
(iii) (text unchanged)
(iv) [Food worker sanitation provides food safety with
effective hand washing and the absence of illness transmissible through food;]
Food is protected by ensuring that all personnel wash hands thoroughly
as often as necessary to prevent food contamination by hand contact;
(v) [Food equipment allows proper processing and sanitation;]
Personnel are restricted from food handling positions or the plant as
indicated if they have an illness or infection that is transmissible through
food as defined in COMAR 10.06.01.06E;
(vi) Food is packaged and labeled for safety with allergens
properly identified on the label;
(vii)—(viii) (text unchanged)
(10) (text unchanged)
[(11) “Dry packaged food” means a nonperishable food that
is:
(a) Not refrigerated; and
(b) Either:
(i) Dry food in a package; or
(ii) Liquid food in a watertight package.]
[(12)] (11) (text unchanged)
[(13)] (12) “Food” means:
(a) [A substance that is used as food or drink for human
beings or as a component of food or drink for human beings; or] Articles
used for food or drink for humans or other animals;
(b) Chewing gum [or any substance that is a component of
chewing gum.]; and
(c) Individual components of such articles.
(13) “Food allergen” means an ingredient that contains protein
derived from one of the following foods or food groups:
(a) Milk;
(b) Egg;
(c) Fish;
(d) Crustacean shellfish;
(e) Tree nuts;
(f) Wheat;
(g) Peanuts;
(h) Soybeans; or
(i) Sesame.
(14) Food Processing Plant.
(a) “Food processing plant” means a place used for or in connection
with wholesale food:
(i) Manufacturing;
[(ii) Preparing;]
[(iii)] (ii) (text unchanged)
[(iv) Packaging;
(v) Canning;
(vi) Freezing;
(vii) Storing;
(viii) Distributing;
(ix) Labeling; or
(x) Holding.]
(iii) Packing;
(iv) Repacking;
(v) Storage; or
(vi) Distribution.
(b) “Food processing plant” includes a:
[(i) Bakery plant;
(ii) Cannery;
(iii) Confectionery plant;]
[(iv)] (i)—[(v)] (ii) (text
unchanged)
[(vi) Food warehouse;]
(iii) Cold food warehouse;
(iv) Ambient food warehouse, except as specified in §B(14)(c) of
this regulation;
[(vii) Food distribution center;
(viii) Frozen food processing plant;
(ix) Ice manufacturing plant;]
[(x)] (v) (text unchanged)
[(xi) Soft drink manufacturing plant;]
[(xii)] (vi) (text unchanged)
[(xiii) Food transfer station;]
[(xiv)] (vii)—[(xvii)] (x)
(text unchanged)
(c) “Food processing plant” does not include a warehouse or
distribution center that:
[(i) Does not process food; and]
[(ii)] (i) Stores only sealed containers of [water,
ice, whole bean, ground or instant coffee, leaf or instant teas, nondairy
dehydrated whiteners, sugar, or sugar-free sweeteners.] pre-packaged,
ready-to-eat snack foods that do not require temperature control for safety;
(ii) Stores only bottled beverages that do not require
temperature control for safety;
(iii) Stores only packaged ice;
(iv) Stores only whole bean, ground or instant coffee, or leaf
or instant teas;
(v) Stores only nondairy dehydrated whiteners, sugar, or
sugar-free sweeteners; or
(vi) Is a food transfer station where food is transferred
between transportation vehicles or there is an area maintained for food that is
stored for less than 24 hours.
[(15) “Food transfer station” means a food processing plant
where:
(a) Food is transferred between transportation vehicles; and
(b) There is an area maintained for food storage.]
[(16)] (15) (text unchanged)
(16) “Hazard” means any biological, chemical (including
radiological), or physical agent that has the potential to cause illness or
injury.
(17) [“HACCP plan” means a] “Hazard Analysis
Critical Control Point (HACCP)” means a management system that
addresses the safety of food that is temperature controlled for safety (TCS) at
critical control points as specified by:
(a) COMAR 10.15.10 Procedures for the Safe Handling and
Processing of Seafood;
(b) COMAR 10.15.12 Procedures for the Safe Handling and
Processing of Juice;
(c) 21 CFR Part 123 Fish and Fishery Products; or
(d) (text unchanged)
(18) “Indirect food additive” means a substance that is
unintentionally incorporated into food due to processing, holding, or
packaging.
[(18)] (19)—[(20)] (21)
(text unchanged)
[(21) “Morgue area” means an area within a food processing
plant in which food that is adulterated is temporarily stored awaiting
disposition.]
(22) (text unchanged)
[(23) Potentially Hazardous Food.
(a) “Potentially hazardous food” means a natural or synthetic food
that requires temperature control because the food is in a form capable of
supporting:
(i) The rapid and progressive growth of infectious or toxigenic
microorganisms;
(ii) The growth and toxin production of Clostridium botulinum; or
(iii) In raw shell eggs, the growth of Salmonella Enteritidis.
(b) “Potentially hazardous food” does not include a food with a:
(i) Water activity (aw) value of 0.85 or less;
(ii) pH level of 4.6 or below when measured at 75°F; or
(iii) Commercially sterile food in a hermetically sealed container.]
(23) “Potable water” means a water supply that meets the
requirements of the Safe Drinking Water Act, as administered by the EPA and
COMAR 26.04.02.01B(33).
(24) “Poultry” means [a] any domesticated
bird [whether dead or alive].
(25) Preventive Controls.
(a) “Preventive controls” means a step or combination of steps
that are taken to minimize, prevent, or eliminate:
(i) Identified food safety hazards; or
(ii) Food safety hazards that are reasonably likely to occur.
(b) “Preventive controls” includes:
(i) Process controls;
(ii) Allergen controls;
(iii) Sanitation controls; and
(iv) Other appropriate controls taken at critical control points
or at other points as necessary to ensure food safety based on the outcome of a
hazard analysis.
(26) “Preventive controls qualified individual (PCQI)” means an
individual who has:
(a) Successfully completed training in the development and
application of risk-based preventive controls; or
(b) The education, experience, and knowledge to develop and
implement a food safety system.
[(25)] (27) (text unchanged)
[(26)] (28) “Process” means[:
(a) An operation involved in commercial food manufacturing and
distribution, including the operations set forth in §B(13)(a) of this
regulation; or
(b) A] a specific set of operations or procedures
used to manufacture a food.
[(27)] (29) “Process authority” means an
individual having expert knowledge of specialized food processes
acquired through [training and experience with a food process.]:
(a) Training; and
(b) Experience.
[(28)] (30) Producer Mobile Farmer’s Market
Unit.
(a) (text unchanged)
(b) “Producer mobile farmer’s market unit” does not include a unit
used to deliver:
(i)—(ii) (text unchanged)
(iii) [Non-potentially hazardous on-farm] On-farm
home processed foods that do not require temperature control for safety.
[(29) “Public festival or event” means a planned gathering
that is open to the public and is regulated by the State or local jurisdiction
where the public festival or event takes place.
(30) “Reduced oxygen package” means a food package in which the
amount of oxygen in the package is below that found in the surrounding
atmosphere due to the:
(a) Mechanical evacuation of oxygen;
(b) Displacement of oxygen with one or more other gases; or
(c) Reduction of the oxygen content by other means.]
(31) “Qualified auditor” means a qualified individual with
necessary technical expertise regarding hazards being controlled to evaluate
food safety regulations and review a supplier’s written plan, for example, the
Hazard Analysis and Critical Control Point (HACCP) plan or other food safety
plan, and its implementation through:
(a) Education;
(b) Training; or
(c) Experience.
(32) “Qualified individual” means a person who is able to handle
food safely as appropriate to the individual’s assigned duties, as determined
by having the:
(a) Education;
(b) Training; or
(c) Experience.
[(31)] (33) “Scheduled process” means a method
or set of procedures [determined] established by a process
authority for processing a food, which [takes into account] includes
the critical factors that may impact the food’s safety or stability to
achieve and maintain a food that will not permit the growth of microorganisms
having public health significance.
[(32)] (34) (text unchanged)
[(33)] (35) “Shell eggs” means raw or
treated eggs produced by [chickens] poultry for human
consumption.
[(34) “Vending machine” means a machine that dispenses or
provides food to a consumer.]
(36) “Snack foods” means chips, pretzels, candy, and other
novelty snacks.
(37) “Temperature control for safety (TCS)” means a food
requires specific time and temperature control to limit pathogenic
microorganism growth or toxin formation for safety.
.04 Compliance with Other Chapters.
The person-in-charge shall manufacture, process, pack/repack,
label, store, [and transport] or distribute food and
design, operate, and maintain a food processing plant and the facilities and
equipment associated with a food processing plant in compliance with this
chapter and with COMAR 10.15.01, 10.15.02, 10.15.07, 10.15.10, and 10.15.12, as
applicable.
.05 Personnel.
The person-in-charge shall ensure that:
A. Individuals do not cause contamination of:
(1) Food;
(2) Food-contact surfaces; and
(3) Food-packaging material;
B. Individuals are excluded from working with food, food-contact
surfaces, and food-packaging materials:
(1) As provided in COMAR 10.06.01.06E; and
(2) When an individual has an:
(a) Illness transmissible through food; or
(b) Exposed and open sore or cut;
C. Individuals working in direct contact with food, food-contact
surfaces, and food-packaging material:
(1) Wear suitable, clean outerwear garments in a manner that
protects the food, food-contact surfaces, and food-packaging material against
contamination;
(2) Wear hair nets, beard covers, or other effective hair
restraints;
(3) Keep fingernails clean and neatly trimmed;
(4) Prevent fingernail polish or artificial fingernails from
coming into contact with food, food-contact surfaces, and food-packaging
material;
(5) Remove all unsecured jewelry and other objects that may fall
into food, equipment, or containers;
(6) Secure any jewelry that cannot be removed with material
which can be maintained in an intact, clean, and sanitary condition;
(7) Wash hands and exposed arm areas thoroughly with soap and
warm water:
(a) At a hand washing facility in compliance with regulation
.12G of this chapter;
(b) Before starting work;
(c) After each absence from the workstation; and
(d) At any other time when hands may have become soiled or
contaminated or as often as required to remove soil and contamination; and
(8) Apply sanitizer as necessary to protect against
contamination with undesirable microorganisms;
D. Individuals wearing gloves while working with food or
food-contact surfaces shall:
(1) Use gloves that are intended for food contact;
(2) Maintain gloves in an intact, clean, and sanitary condition;
(3) Wash hands thoroughly before putting on gloves;
(4) Clean and sanitize reusable gloves using approved methods or
equipment.
(5) Replace gloves:
(a) When the gloves are damaged or soiled;
(b) Between unrelated tasks; and
(c) After an interruption in working with food or food-contact
surfaces;
E. Individuals store personal items in a designated area other
than where food is exposed or stored, or where equipment or utensils are
washed;
F. Individuals do not use tobacco, chew gum, eat food, drink
beverages, or engage in any activity that might contaminate food in an area
that is used for:
(1) Food processing;
(2) Equipment or utensil washing;
(3) Storage of:
(a) Food;
(b) Food-contact surfaces; or
(c) Food packaging;
G. Individuals prevent allergen cross-contact and contamination
with microorganisms, deleterious substances, or foreign matter of food,
food-contact surfaces, and food-packaging materials;
H. Education and training in personal hygiene, food handling,
and plant sanitation is provided to personnel, food handlers, and supervisors
in a language and form they understand as it relates to assigned duties such
that:
(1) Each individual engaged in food handling or in the
supervision of one or more individuals be qualified by:
(a) Education;
(b) Training;
(c) Experience; or
(d) A combination of education, training, and experience;
(2) Responsibility for education and training shall be clearly
assigned to qualified supervisory personnel; and
(3) Records that document each individual’s training are
maintained according to Regulation .06 of this chapter; and
I. When specialized personnel training is required by COMAR
10.15.01, 10.15.02, 10.15.07, 10.15.10, or 10.15.12 or this chapter, or 21 CFR
Part 112, Subpart M, the specialized training is obtained as required.
.06 General Record
Keeping.
The person-in-charge shall ensure that all required records:
A. Be kept as original records, true copies, or electronic
records;
B. Identify the name and location of the food processing plant;
C. Contain the time and date the activity was performed and
documented;
D. Include the signature or initials of the individual
performing and documenting the activity;
E. Contain actual values and observations obtained during
monitoring and verification activities;
F. Be accurate, indelible, and legible;
G. Be created concurrently with performance of the activity
documented;
H. Be as detailed as necessary to provide a history of work
performed;
I. Identify the product and lot code if applicable;
J. Are original or accurate reproductions of the original and
are retained at the plant or facility for at least 2 years after the date they
were prepared; and
K. Are made available to an authorized representative of the
Department for official review and reproduction upon oral or written request.
.07 Food Protection,
Processes, and Controls.
The person-in-charge shall ensure that:
A. All food and food ingredients processed in a food processing
plant:
(1) Are from an approved source;
(2) Are GRAS;
(3) If applicable, conform to a standard of identity, as defined
in 21 CFR Part 130;
(4) Comply with FDA regulations for poisonous or deleterious
substances; and
(5) Are identified and held in a manner that prevents allergen cross-contact
if the food and food ingredients are an allergen or contain an allergen;
B. When ice is used in contact with food, it shall be:
(1) Made from potable water; and
(2) Manufactured and stored in accordance with this chapter;
C. Compressed air or other gasses mechanically introduced into
food do not contaminate the food with unlawful indirect food additives;
D. Raw materials and other ingredients:
(1) Are inspected at receipt to ensure that they are acceptable
for use; and
(2) Are washed or cleaned as necessary to remove soil or other
contamination;
E. Food is processed and stored under conditions and control
procedures that prevent and protect from:
(1) Contamination; and
(2) Allergen cross-contact;
F. The potential for contamination and allergen cross-contact is
reduced by:
(1) Food safety controls;
(2) Operating practices; and
(3) Separation of operations by:
(a) Location;
(b) Time; or
(c) Effective design;
G. Food is processed and stored at temperatures that:
(1) Minimize the potential for the growth of microorganisms; and
(2) Prevent adulteration;
H. The thermal processing of food eliminates or reduces the
number of pathogens in the food so that the food is safe for human consumption;
I. The cooling of foods is conducted using methods that:
(1) Minimize the potential for the growth of microorganisms; and
(2) Prevent adulteration;
J. Foods that require temperature control for safety are
maintained at the temperature:
(1) 38°F or less for foods with a non-proteolytic Clostridium
botulinum potential hazard;
(2) 40°F or less;
(3) 45°F or less for molluscan shellfish or shell eggs;
(4) 135°F or higher; or
(5) As otherwise approved by the Department;
K. Food that relies principally on the control of aw
for preventing the growth of undesirable microorganisms shall be processed to
and maintained at a safe moisture level;
L. Food that relies principally on the control of pH for
preventing the growth of undesirable microorganisms shall be monitored and
maintained at a pH of 4.6 or below;
M. Adequate measures are taken to protect against the inclusion
of metal or other extraneous material in food;
N. Frozen food remains frozen when stored or removed from
refrigeration in order to be segregated, organized, or moved;
O. Frozen foods are thawed in a manner that prevents
contamination;
P. Any food, raw material, or ingredient that is adulterated is
not offered to human beings and is:
(1) Rejected upon receipt;
(2) Treated or processed to eliminate the contamination;
(3) Destroyed in a manner that protects against the
contamination and allergen cross-contact of other food;
(4) Stored only in a designated area that is:
(a) Separated from all other food and food process operations;
and
(b) Conspicuously marked with the intended disposition;
(5) Reconditioned using a method that is safe and effective;
(6) Reexamined following reconditioning and subsequently found
not to be adulterated;
(7) Not mixed with another lot of food that is not adulterated;
and
(8) If detained by the Department:
(a) Reconditioned; or
(b) Destroyed in a manner approved by the Department;
Q. A facility that only stores unexposed packaged foods that
require time and temperature control to significantly minimize or prevent
pathogens:
(1) Establishes and implements temperature controls that
significantly minimize or prevent the growth of, or toxin production by,
pathogens;
(2) Monitors the temperature controls with adequate frequency;
(3) Takes appropriate corrective actions if there is a loss of
temperature control that may impact the safety of the food;
(4) Establishes and maintains affirmative or exception records
that document implementation of temperature controls, calibration, or accuracy
checks of temperature monitoring and recording devices, and corrective actions;
(5) Reviews records of monitoring and corrective actions taken
to correct a problem with the control of temperature within:
(a) 7 working days after the records are created; or
(b) A reasonable time frame; and
(6) Reviews records of calibration or accuracy checks within a
reasonable time frame after the records are created;
R. Written standard operating procedures are:
(1) Available to employees in a format they understand;
(2) Implemented; and
(3) Reflective of current manufacturing procedures;
S. When the Department requires a scheduled process, the
scheduled process is:
(1) Established by a process authority;
(2) Used to manufacture the target food;
(3) Not changed without approval of the process authority;
(4) Documented by:
(a) Production records; and
(b) Process deviation records; and
(5) Verified by:
(a) Production records review;
(b) Equipment calibration; or
(c) Laboratory testing;
T. Records that document compliance with this regulation are
maintained in accordance with Regulation .06 of this chapter;
U. Human food by-products for use or distribution as animal food
without additional manufacturing or processing are:
(1) Accurately identified when stored;
(2) Stored under conditions that protect against contamination;
and
(3) Labeled or accompanied by a label identifying the by-product
by the common or usual name when distributed;
V. Finished product testing for chemicals, microbes, or
extraneous materials is conducted when necessary to identify failures to
protect ready to eat food from contamination or allergen cross-contact; and
W. Environmental testing for chemicals or microbes is conducted
when necessary to identify failures to protect ready to eat food from
contamination or allergen cross-contact.
.08 Hazard Analysis and Risk-Based Preventive Controls.
The person-in-charge:
A. Is exempt from this regulation if:
(1) They meet the definition of a qualified facility in 21 CFR
§117.3; or
(2) They meet the qualifications defined in:
(a) 21 CFR §§117.5—117.8;
(b) 21 CFR §117.201;
(c) 21 CFR §§117.251—117.287; and
(d) 21 CFR §117.315(a)(2);
B. Shall ensure that a food safety plan:
(1) Is prepared, implemented, and managed by one or more
individuals qualified in preventative controls;
(2) Is signed and dated by the owner, operator, or agent in
charge:
(a) Upon initial completion;
(b) When any modification takes place; and
(c) At least once every 3 years;
(3) Includes a written hazard analysis that identifies all known
and reasonably likely to occur biological, chemical, and physical hazards
associated with each type of food manufactured in the plant;
(4) Includes written procedures for:
(a) Preventive controls;
(b) Process controls with parameters and values;
(c) Allergen controls;
(d) Sanitation controls;
(e) Other controls necessary as identified in the hazard
analysis;
(f) Monitoring and record keeping for each preventive control
identified in the hazard analysis that include an adequate frequency to control
the hazard;
(g) Corrective actions that:
(i) Identify and correct the problem;
(ii) Reduce the likelihood the problem will recur;
(iii) Evaluate all affected food for safety; and
(iv) Prevent all affected food from entering commerce;
(h) Verification activities that ensure that the preventive
controls are consistently implemented and are effectively and significantly
minimizing or preventing the hazards;
(i) Validation for process controls;
(j) A supply chain program that complies with 21 CFR
§§117.405—117.475 if the receiving facility has identified a hazard requiring a
supply-chain-applied control; and
(k) A recall plan for a food with a hazard requiring a
preventive control, that includes:
(i) Maintaining accurate records to identify the initial
distribution of the food;
(ii) Direct notification of the consignees of the food being
recalled, including how to return or dispose of the affected food;
(iii) Public notification about any hazard presented by the food
when appropriate to protect public health; and
(iv) Effectiveness checks to account for all products affected;
(5) Is implemented to prevent, eliminate, or reduce to an
acceptable level, all identified hazards;
(6) Includes records that document implementation of:
(a) The food safety plan monitoring;
(b) Corrective actions; and
(c) Supply chain, verification, validation, and applicable
training for the preventive controls qualified individual and the qualified
auditor;
(7) Includes that records of monitoring and corrective actions
are reviewed by a preventive controls qualified individual within 7 working
days after the records are created, or within a reasonable time frame; and
(8) Includes that records of verification activities are
reviewed within a reasonable time by a preventive controls qualified
individual; and
C. Shall ensure that a processing plant complies with the 21 CFR
§§117.136—117.137 and 117.335 if results of the hazard analysis determine the
facility is not required to implement preventive controls for a food item.
.09 Plant and Grounds.
The person-in-charge shall ensure that:
A. The food processing plant and grounds around a food
processing plant are:
(1) Maintained free of attractants, breeding places, or
harborage for pests and insects, including:
(a) Unused equipment;
(b) Debris;
(c) Litter;
(d) Waste; or
(e) High weeds or grass; and
(2) Adequately drained to promote sanitation and prevent
breeding places for pests and insects;
B. The design and construction of the plant facilitates
maintenance and sanitary operations for food processing and:
(1) Is suitable in size;
(2) Affords protection against the weather; and
(3) Minimizes the potential for contamination and allergen
cross-contact by providing:
(a) Adequate space for the placement of:
(i) Equipment;
(ii) Utensils; and
(iii) Materials storage; and
(b) Effective designing the flow of food through the plant;
C. Except as provided for in Regulation .15 of this chapter, a
room or area in which food is processed or stored or in which utensils,
equipment, or food-packaging materials are cleaned, sanitized, or stored:
(1) Is separated from other rooms or areas in the plant to
preclude allergen cross-contact and contamination by:
(a) A distance that precludes allergen cross-contact and
contamination; or
(b) Tight fitting:
(i) Walls;
(ii) Ceilings; and
(iii) Self-closing doors;
(2) Is, if not refrigerated, mechanically ventilated using
exhaust and supply fans to ensure:
(a) Filtered air is supplied to provide a positive air pressure
in the room;
(b) Condensation and grease do not accumulate on room surfaces
and equipment; and
(c) Removal of excessive:
(i) Grease vapors;
(ii) Steam;
(iii) Heat; and
(iv) Odors;
(3) Has a floor, walls, and ceiling that are:
(a) Smooth;
(b) Washable;
(c) Easily cleanable; and
(d) Impervious to water;
(4) Has only the exposed overhead pipes, ducts, conduits,
evaporators, and other structures that are needed for proper processing, which
are installed so that food is protected against leakage;
(5) Has floor-wall junctures that are:
(a) Coved; and
(b) Impervious to water;
(6) Has aisles or working spaces between equipment and walls
that:
(a) Are unobstructed;
(b) Of adequate width to permit employees to perform their
duties; and
(c) Protect against the contamination of food, food-contact
surfaces, or food-packaging materials by clothing or personal contact;
(7) Provides adequate lighting in all areas that:
(a) Uses shatter-resistant light bulbs, fixtures, skylights, or
other light sources if suspended over exposed food, food-contact surfaces, or
food-packaging materials in any step of preparation; or
(b) Otherwise protects against food contamination in case of
glass breakage; and
(8) Has well-maintained, sealed walls, floors, and ceilings to
prevent entry or harborage areas for pests;
D. Except as provided for in Regulation .15 of this chapter, an
area is designated for employees to eat, drink, and securely store personal
items which is separate from areas designated for the cleaning, sanitation, or
storage of:
(1) Utensils;
(2) Equipment; or
(3) Food-packaging materials;
E. The food processing plant is completely separated by solid,
impervious floors, walls, and ceilings with no connecting openings from areas
used as living quarters; and
F. Plans provided for review to the Department of the plant,
facilities, and grounds design and construction that are not provided for in
this regulation:
(1) Provide for adequate food safety, food protection, and
sanitation; and
(2) Are equivalent to regulatory and industry standards.
.10 Equipment and
Utensils.
The person-in-charge shall ensure that:
A. Except as provided in §§B and M of this regulation, equipment
and utensils meet one or more of the following sanitation design standards:
(1) National Sanitation Foundation (NSF);
(2) The ETL SEMKO division of Intertek Group PLC (Intertek ETL
SEMKO);
(3) Canadian Standards Association (CSA);
(4) Underwriters Laboratories (UL);
(5) Bakery Industry Sanitation Standards Committee;
(6) National Automatic Merchandising Association;
(7) International Association of Food Protection;
(8) American Society of Mechanical Engineers;
(9) U.S. Department of Agriculture; or
(10) Another applicable published standard acceptable to the
Department;
B. When design standards conflict with State laws, codes, or
regulations, the State laws, codes, or regulations are followed;
C. Food processing equipment and utensils are:
(1) Designed and constructed to allow for adequate cleaning and
sanitizing;
(2) Installed in a way to facilitate cleaning, sanitizing, and
maintenance of the equipment and the surrounding areas, including equipment
that does not come in contact with food;
(3) Designed and constructed to prevent contamination and
allergen cross-contact; and
(4) Maintained in:
(a) Proper working condition; and
(b) A manner that protects against contamination and allergen
cross-contact;
D. Each freezer and cold storage unit used to store and
transport food capable of supporting growth of microorganisms:
(1) Maintains temperatures that ensure food safety and protect
against spoilage;
(2) Is fitted with an indicating thermometer,
temperature-measuring device, or temperature-recording device that is:
(a) Calibrated to be accurate to within plus or minus 2°F; and
(b) Placed in a conspicuous location to show the temperature
accurately within the unit;
E. All food-contact surfaces are designed, constructed, and
maintained to be:
(1) Smooth;
(2) Easily cleanable;
(3) Durable;
(4) Non-absorbent;
(5) Constructed of food grade material where applicable;
(6) Corrosion resistant;
(7) Made of nontoxic material that does not impart toxic or
deleterious matter to the food;
(8) Inert to food and do not migrate into or adulterate food;
and
(9) Smoothly bonded at the seams and maintained to minimize
accumulation of:
(a) Food particles;
(b) Dirt; and
(c) Organic matter;
F. Food-packaging material:
(1) Is food grade;
(2) Is safe;
(3) Is able to maintain food safety and integrity;
(4) Is appropriate for the food item and the intended use;
(5) Is not reused if intended for single-service;
(6) Meets the labeling requirements in Regulation .13B(2) of
this chapter;
(7) Does not migrate to or have the potential to be absorbed by
food; and
(8) Complies with the requirements of the U.S. Food and Drug
Administration in 21 CFR Parts 174—178 for indirect food additives;
G. Instruments and controls required for measuring, regulating,
or recording temperatures, pH, acidity, water activity, or other conditions
that control or prevent the growth of undesirable microorganisms in food are
accurate and adequate in number for their designated uses;
H. Thermometers used to monitor required temperatures are
calibrated or checked for accuracy annually using an approved method;
I. Compressed air or other gasses mechanically used to clean
food-contact surfaces or equipment are treated in such a way that food is not
contaminated with unlawful indirect food additives;
J. Non-food-contact equipment is:
(1) Smooth;
(2) Easily cleanable;
(3) Durable; and
(4) Non-absorbent;
K. The food storage area of a transportation vehicle is
maintained in:
(1) Good repair;
(2) Working condition; and
(3) A manner that protects against contamination of food;
L. Containers, equipment, and vehicles used to convey or hold
human food by-products for use as animal food are designed and constructed of
appropriate material to protect against contamination; and
M. Equipment submitted to the approving authority for review
that meets the provisions of §§C—E of this regulation but fails to comply with
§A of this regulation is:
(1) Not harmful to public health; and
(2) Consistent with industry standards and practice.
.11 Sanitary Operation.
The person-in-charge shall ensure that:
A. All food processing, food storage, and food-packaging storage
areas are maintained in a clean and sanitary manner;
B. Equipment is used and maintained to avoid contamination and
allergen cross-contact of food;
C. Food-packaging material is stored to be protected from
contamination;
D. Overall sanitation of the plant is under the supervision of
one or more qualified individuals;
E. The equipment and facilities needed for cleaning and
sanitizing food-contact surfaces are provided and maintained in a sanitary
condition;
F. Cleaning and sanitizing of plant facilities, equipment, and
utensils are conducted in a manner that protects against allergen cross-contact
and against contamination of:
(1) Food;
(2) Food-contact surfaces; and
(3) Food-packaging materials;
G. All food-contact surfaces are cleaned and sanitized as
frequently as necessary to protect against allergen cross-contact and against
contamination of food;
H. Before use, food-contact surfaces used for processing or
holding low-moisture food are:
(1) Clean;
(2) Dry; and
(3) Sanitary;
I. Food-contact surfaces are cleaned and sanitized before use
and after any interruption during which the food-contact surfaces may have
become contaminated;
J. When equipment and utensils are washed, rinsed, and sanitized
using a three-compartment sink:
(1) Each sink compartment is sized to allow sufficient immersion
of the equipment or utensils; and
(2) The washed, rinsed, and sanitized items are dry before
stacking or nesting;
K. Non-food-contact surfaces of equipment used in the operation
of a food plant are cleaned as frequently as necessary to be maintained in a
sanitary condition;
L. Cleaned equipment and utensils are stored to prevent
contamination of the equipment and utensils;
M. Toxic chemicals, cleaning compounds, sanitizing agents, and
pesticide chemicals used in the facility are:
(1) Safe and adequate under the conditions of use;
(2) Used in accordance with the manufacturer’s instructions and
applicable State laws and regulations; and
(3) Identified and stored in a manner that protects against
contaminating:
(a) Food;
(b) Food-contact surfaces; or
(c) Food-packaging materials;
N. All processing and storage areas are maintained free of
pests;
O. Effective measures are taken to:
(1) Monitor for and exclude pests from processing and storage
areas; and
(2) Protect against the contamination of food by pests;
P. The food storage area of a transportation vehicle is:
(1) Maintained in a clean and sanitary condition; and
(2) Inspected as often as necessary to maintain it in a clean
and sanitary condition;
Q. Containers, equipment, and vehicles used to convey or hold
human food by-products for use as animal food before distribution are:
(1) Cleaned as necessary;
(2) Examined prior to use to protect against contamination from
the container or vehicle; and
(3) Maintained to protect against contamination; and
R. If ready-to-eat foods are processed, environmental testing is
conducted when necessary to demonstrate effectiveness of sanitation operations.
.12 Sanitary Facilities
and Controls.
The person-in-charge shall ensure that:
A. The water supply is adequate for the operations intended and
is:
(1) From an approved potable source;
(2) At an adequate temperature;
(3) Under adequate pressure; and
(4) Protected against backflow;
B. All plumbing is of adequate size and is designed, installed,
and maintained to:
(1) Carry adequate quantities of water to required locations
throughout the plant;
(2) Convey sewage and liquid waste from the plant;
(3) Prevent contamination of:
(a) Food;
(b) Water supplies;
(c) Equipment;
(d) Utensils; and
(e) Food-packaging materials;
(4) Ensure sanitary conditions;
(5) Prevent backflow from, or cross-connection between, piping
systems that carry wastewater and potable water; and
(6) Be in compliance with State and local codes;
C. Adequate floor drainage is provided in all areas where:
(1) Floors are subject to water accumulation during cleaning; or
(2) Normal operations release or discharge water or other liquid
waste on the floor;
D. Floors are sloped to floor drains to prevent water
accumulation and ponding;
E. Sewage and wastewater is discharged:
(1) In compliance with applicable laws and regulations;
(2) Into a sewage disposal system that meets all applicable
State and local codes; or
(3) Through other acceptable means approved by the Department;
F. Toilet facilities:
(1) Are readily accessible and adequate in number for employee
use;
(2) Are kept clean and are not a potential source of
contamination of:
(a) Food;
(b) Food-contact surfaces; and
(c) Food-packaging materials; and
(3) Are provided with:
(a) Signage that instructs individuals to wash their hands
before returning to work;
(b) Mechanical air exhaust and intake of an equal amount of
makeup air at the rate of 2 cubic feet per minute of air for each square foot
of floor area or a screened window that allows the adequate exchange of outside
air;
(c) Floors, walls, and a ceiling that are:
(i) Smooth;
(ii) Washable;
(iii) Easily cleanable; and
(iv) Impervious to water;
(d) Floor-wall junctures that are sealed to be impervious to
water;
(e) Adequate lighting; and
(f) Hand washing facilities as specified in §G of this
regulation;
G. Hand washing facilities:
(1) Are provided that are adequate in number and conveniently
located in areas where food is processed or equipment or utensils are washed
and sanitized; and
(2) Are supplied with:
(a) Soap;
(b) Warm water of sufficient volume, under pressure for
effective hand washing;
(c) Paper towels or warm air hand drying device;
(d) A conveniently located trash receptacle; and
(e) Hand sanitizer, if necessary to protect against
contamination; and
H. Solid waste:
(1) Is handled and disposed of using waste containers that are:
(a) Adequate in number and size to maintain sanitary conditions;
(b) Conveniently located where waste is generated;
(c) Easily cleanable;
(d) Leak proof; and
(e) Emptied and cleaned at a frequency that maintains sanitary
conditions; and
(2) Is handled, stored, and disposed of in a manner that:
(a) Minimizes the development of odors;
(b) Minimizes the potential for becoming an attractant or
harborage for pests;
(c) Meets all applicable State and local codes; and
(d) Protects against contamination of:
(i) Food;
(ii) Food-contact surfaces;
(iii) Food-packaging materials;
(iv) Water supplies; and
(v) Plant and grounds.
.13 Labeling.
A. In accordance with Health-General Article, §21-212, Annotated
Code of Maryland, a federal rule that exempts a food from label requirements is
effective automatically in the State.
B. The person-in-charge shall ensure that:
(1) Except as provided in §A of this regulation, food labeling
meets the requirements in 21 CFR Part 101;
(2) Except as provided in §A of this regulation, the following
information is provided on a label of food in packaged form:
(a) Common or usual name of the food;
(b) Statement of ingredients that gives the common or usual
names of the ingredients in descending order of prominence with sub-ingredients
listed;
(c) Name and address of the manufacturer or distributor with:
(i) The full street address including the zip code of the
manufacturer or distributor if the address is not listed on a website, current
city directory, or telephone directory; or
(ii) A minimum of the town and zip code if the manufacturer or
distributor is listed on a website, current city directory, or telephone
directory;
(d) Net quantity in terms of:
(i) Weight in U.S. Customary units and equivalent metric units;
(ii) Fluid measure in U.S. Customary units and equivalent metric
units;
(iii) Numerical count; or
(iv) Combination of numerical count and weight;
(e) If a food coloring has been added, the food coloring in the
statement of ingredients;
(f) If a chemical preservative has been added, a label
declaration stating:
(i) The common or usual name of the ingredient; and
(ii) A separate description of its function such as
“preservative” or “mold inhibitor”;
(g) Major food allergens in accordance with 21 U.S.C. §343(w);
(h) For a food that requires refrigeration for safety, the words
“keep refrigerated” or equivalent;
(i) For a food that requires refrigeration for safety after the
food’s packaging is opened, the words “refrigerate after opening” or
equivalent;
(j) For a food that is frozen for safety or quality, the words
“keep frozen” or equivalent;
(k) A “use by date” if the package contains a food whose safety
is assured only until the date specified on the label;
(l) For a food that is frozen during processing or after
processing and then thawed before being offered for human consumption, the
words “previously frozen, should not refreeze”; and
(m) The exact words “WARNING: This product has not been
pasteurized and, therefore, may contain harmful bacteria that can cause serious
illness in children, the elderly, and persons with weakened immune systems.”
for a juice product that has not been processed in accordance with COMAR
10.15.12;
(3) A food label and the labeling information in §B(1) of this
regulation are:
(a) Durable;
(b) Conspicuous;
(c) Legible;
(d) Able to remain on a container for the shelf life of the
food; and
(e) Placed on the food container by:
(i) Imprinting;
(ii) Embossing;
(iii) Lithography;
(iv) Ink jetting; or
(v) Another method set forth in 21 CFR Parts 100 and 101 or in
conformance with §B(2) of this regulation;
(4) The information required in §B(2) of this regulation is
located on the principal display panel;
(5) If the food is not manufactured by the business whose name
appears on the label, the business name is qualified by a phrase that reveals
the connection the business has with the food, such as “Manufactured for” or
“Distributed by”;
(6) If the address given on the label is not the place where the
food was actually manufactured, packaged, or distributed, it is the address of
the principal place of business of the manufacturer or distributor given on the
label;
(7) A food’s labeling or packaging is not false or misleading in
any way; and
(8) A food that has been frozen or thermally processed is not
labeled “fresh”.
C. The person-in-charge may forego:
(1) Declaring on the label the common or usual name of each
ingredient for incidental additives that:
(a) Have no technical or functional effect in the food; and
(b) Are not required by a federal rule to be declared; and
(2) Complying with the requirements in §B(2)(a)—(f) and (j) of
this regulation for a shipment of food that, in accordance with the practice of
trade, is processed, labeled, or repacked in substantial quantity at an
establishment other than where originally processed or packed if:
(a) The person who introduced the shipment of food into
interstate commerce is the operator of the establishment where the food is to
be processed, labeled, or repacked; or
(b) The shipment or delivery to the establishment is made under
a written agreement as set forth in 21 CFR §101.100(d).
.14 Facility Process and
Plan Review.
A. The person-in-charge shall ensure that plans and
specifications are submitted to the Department:
(1) Before:
(a) A food processing plant is:
(i) Constructed;
(ii) Remodeled; or
(iii) Materially altered;
(b) An existing building or structure is converted or remodeled
for use as a food processing plant;
(c) A food or process is added or significantly modified; or
(d) A new scheduled process or shelf life study is used; and
(2) That include the following information, as applicable:
(a) A scale drawing in horizontal view that identifies the:
(i) Layout and arrangement of work areas;
(ii) Location of food equipment including exhaust ventilation
hoods; and
(iii) Location of plumbing and plumbing fixtures such as water
lines, sewer lines, hand sinks, toilets, utility sinks, utensil washing sinks,
floor drains, floor sinks, and hose stations;
(b) Specifications for the:
(i) Construction materials for the building and interior
finishes;
(ii) Disposal of sewage;
(iii) Provision of potable water;
(iv) Exclusion and control of pests;
(v) Ventilation of the plant and individual areas within the
plant;
(vi) Methods and facilities for waste storage and disposal; and
(vii) Lighting;
(c) A complete list of specifications for the proposed
equipment;
(d) A written description of the foods to be processed, stored,
or distributed;
(e) Written standard operating procedures for:
(i) Processing foods named in §A(2)(d) of this regulation;
(ii) Employee health and personal hygiene; and
(iii) Plant sanitation;
(f) When required by Regulation .02, .07, .10, or .12 of this
chapter, a HACCP plan;
(g) When required by the Department, a scheduled process or
shelf life study, performed by a process authority;
(h) When required by the Department, a laboratory analysis,
performed by a laboratory with a current accreditation to the ISO/IEC 17025;
(i) A hazard analysis and food safety plan as required by
Regulation .08B and C of this chapter; and
(j) Any other information that may be required by the Department
to ascertain compliance of the plans and specifications with all applicable
federal, State and local laws, regulations, and ordinances.
B. The person-in-charge may not construct a new food processing
plant, remodel an existing food processing plant, or manufacture a food using a
new or modified process before receiving written approval of the plans and
specifications from the Department.
C. The Department shall:
(1) Review the plans and specifications to ensure compliance
with the applicable regulations;
(2) Inform in writing the individual who submitted the plans and
specifications:
(a) Of additional information that may be required; and
(b) Following the review, whether the plans and specifications
are approved or denied; and
(3) If the plans are denied, provide the individual in writing
who submitted the plans and specifications with information on how to appeal
the decision, as set forth in State Government Article, Title 10, Subtitle 2,
Annotated Code of Maryland.
D. The person-in-charge shall ensure that before a new or
remodeled food processing plant is operated:
(1) The Department schedules and completes an inspection;
(2) The Department issues written approval for the use of the
new or remodeled plant; and
(3) For a new plant, a food processing license is obtained.
E. The Department shall:
(1) Review the plans and specifications to ensure compliance
with the applicable regulations;
(2) Conduct a priority assessment of the facility based on the
information obtained pursuant to §A(2)(d) and (e) of this regulation; and
(3) Classify a food processing plant as a:
(a) High priority facility, if the food processing plant
manufactures food:
(i) Using specialized processes that require a scheduled process
or a HACCP Plan;
(ii) Using ingredients that require temperature control for
safety; or
(iii) That is temperature controlled for safety;
(b) Moderate priority facility, if the food processing plant:
(i) Manufactures food using ingredients that do not require
temperature control for safety;
(ii) Manufactures food that is not temperature controlled for
safety; or
(iii) Is a food warehouse that stores and distributes food that
requires temperature control for safety; or
(c) Low priority facility, if the food processing plant is a
food warehouse that stores food or ingredients that do not require temperature
control for safety.
F. The Department may allow the use of equipment that meets the
requirements of Regulation .10C—E of this chapter but fails to comply with
Regulation .10A of this chapter if a review indicates the equipment and its use
are:
(1) Not harmful to public health; and
(2) Consistent with industry standards and practices.
G. The Department may accept plant, facilities, and grounds
design and construction other than those that are provided for in Regulation
.09 of this chapter based on a review that shows the alternative plant,
facilities, and grounds design:
(1) Provides for adequate food safety, food protection, and
sanitation; and
(2) Is equivalent to regulatory and industry standards.
.15 On-Farm Home
Processing.
A. The Department may issue a food processing plant license to
an individual who owns a farm to process food in a home or domestic kitchen,
located on the individual’s farm, as set forth in this regulation.
B. While operating with a license issued in accordance with §A
of this regulation, the person-in-charge shall:
(1) Comply with this chapter except for:
(a) Regulation .09C(2)(a), D, and E; and
(b) Regulation .12D, F(3), and G(1);
(2) Limit processed food production to:
(a) An amount of food that can safely be produced in the
domestic kitchen as evidenced by:
(i) Sanitation;
(ii) Process; and
(iii) Cross-contamination control; or
(b) $40,000 of sales;
(3) Process commercially only during times when the kitchen is
not being used for domestic purposes;
(4) Clean and sanitize all food-contact surfaces, equipment, and
utensils, immediately before and after processing commercially;
(5) While processing commercially:
(a) Use only building areas, equipment, and utensils that the
Department has reviewed or inspected and approved; and
(b) Remove all animals and individuals not involved in food
processing from the kitchen; and
(6) Store ingredients for commercial manufacturing and finished
manufactured food in a separate area from foods used domestically.
C. Except as provided in §§E and F of this regulation, an
individual licensed in accordance with this regulation may manufacture and
process only:
(1) Baked cakes, muffins, or cookies with a water activity of
.85 or less;
(2) Fruit pies with an equilibrated pH of 4.6 or less;
(3) Canned acid foods with an equilibrated pH of 4.6 or less;
(4) Herbs in vinegar with an equilibrated pH of 4.6 or less;
(5) Honey and herb mixtures;
(6) Dried fruits and vegetables; and
(7) Acidified foods.
D. An individual licensed in accordance with this regulation may
not process:
(1) Low-acid canned foods;
(2) Cured or fermented foods;
(3) Except as provided in §E(6) of this regulation, seafood;
(4) Apple cider or other juices;
(5) Grade A milk product or manufactured grade milk product as
defined in Health-General Article, §21-401, Annotated Code of Maryland; and
(6) A frozen dessert as defined in Health-General Article,
§21-801(b), Annotated Code of Maryland.
E. An individual licensed in accordance with this regulation
may:
(1) Weigh, label, and sell raw meat and poultry that is under
the jurisdiction of the United States Department of Agriculture;
(2) Distribute raw meat or poultry that is under the
jurisdiction of the United States Department of Agriculture;
(3) Weigh, package, label, and sell raw meat and poultry that is
inspected by the Maryland Department of Agriculture in accordance with
Regulation .20 of this chapter;
(4) Distribute raw meat or poultry that is inspected by the
Maryland Department of Agriculture in accordance with Regulation .20 of this
chapter;
(5) Process only animals that were:
(a) Commercially raised, fed, or managed on the farm; and
(b) Slaughtered and processed in accordance with Regulation .17
of this chapter;
(6) While operating a fish farm, clean, weigh, package, label,
and sell, or distribute, raw finfish from the farm that are not associated with
histamine intoxication; and
(7) Use shared equipment and utensils for both domestic and
commercial uses provided that the equipment and utensils are:
(a) Designed and constructed as set forth in Regulation .10 of
this chapter; and
(b) Cleaned and sanitized as set forth in Regulation .11 of this
chapter.
F. An individual licensed in accordance with this regulation may
weigh, label, store, and distribute cheese that:
(1) Is made on a licensed out-of-State dairy farm using only the
raw milk produced by the herd on the dairy farm licensed by the Department; and
(2) Meets the definition and standards of a hard cheese, as set
forth in section 21 CFR §133.150.
G. When a farm ceases to be a farm, a food processing license
issued in accordance with this regulation becomes void.
H. In the absence of a license issued in accordance with COMAR
10.15.03, a license issued in accordance with this regulation shall provide for
the sale on the farm of food processed on the farm by the licensee.
I. Except as provided in Regulation .17 of this chapter, a
person may not process food for human consumption on a farm without the license
required in Regulation .18A of this chapter.
.16 Producer Mobile
Farmer’s Market Unit.
A. The Department may issue a food processing plant license to
operate a producer mobile farmer’s market unit to transport for sale at a
farmer’s market TCS food products:
(1) Produced or stored on the farm by the licensee under an
on-farm home processing plant license;
(2) Produced or stored on the farm by the licensee, as
authorized by the Department in regulation; or
(3) That have been inspected, licensed, or certified for food
safety by the Maryland Department of Agriculture.
B. The person-in-charge shall ensure that the producer mobile
farmer’s market unit:
(1) Complies with Regulations .07G, N, and O and .10D, H, and K
of this chapter; and
(2) Displays the license on the unit during operation.
C. A local health department shall:
(1) Enforce §B of this regulation;
(2) Levy fines as established in local law, ordinance, or
regulation; and
(3) Notify the Department of any violations occurring in the
county.
.17 Animal Slaughtering,
Meat Processing, and Poultry Processing.
A person that slaughters animals and processes meat shall ensure
that:
A. Animal slaughtering, meat processing, poultry processing,
meat sales, and poultry sales are regulated and inspected in conformance with
the applicable:
(1) Federal laws;
(2) Federal regulations;
(3) State laws;
(4) State regulations;
(5) Local laws; and
(6) Local regulations;
B. Cattle, sheep, swine, goats, horses, mules, and other equine
are slaughtered and processed in accordance with:
(1) The Federal Meat Inspection Act, 21 U.S.C. §§601—695; and
(2) Applicable federal, State, and local laws and regulations;
C. Poultry are slaughtered and processed in accordance with:
(1) The Poultry Products Inspection Act, 21 U.S.C. §§451—471;
and
(2) Applicable federal, State, and local regulations;
D. When slaughtered and processed for food for the public,
domesticated animals, including poultry and rabbits that are not required by
federal law or regulation to be inspected by the United States Department of
Agriculture, are:
(1) Inspected by the:
(a) United States Department of Agriculture under a voluntary
inspection program; or
(b) Maryland Department of Agriculture under a voluntary
inspection program; and
(2) Processed into human food while being regulated by:
(a) The United States Department of Agriculture under a
voluntary inspection program; or
(b) A meat inspection program or poultry inspection program
administered by the Maryland Department of Agriculture; and
E. When processing deer meat for charitable donation:
(1) Any processed deer is legally harvested;
(2) Gutting and skinning of the deer and butchering operations
shall be separated by:
(a) Time; or
(b) Distance;
(3) Processing other animal species is separated by:
(a) Time; or
(b) Distance;
(4) Hanging meat carcasses are stored at an internal temperature
of 41°F or less;
(5) Deer is processed for distribution only as fresh or frozen:
(a) Raw whole cuts; or
(b) Raw, ground 100 percent venison;
(6) Organ meat is not donated; and
(7) A label containing cooking instructions is included.
.18 Licensing.
A. In order to operate a food processing plant, a person shall
obtain a food processing license pursuant to the provisions of:
(1) Health-General Article, §§21-211 and 21-305, Annotated Code
of Maryland; and
(2) This chapter.
B. The Department shall specify on the food processing license
what foods or food types the licensee is authorized to process.
C. The Department shall deny an application for a license if the
applicant:
(1) Does not meet the requirements of:
(a) Health-General Article, §21-211, or Title 21, Subtitle 3,
Annotated Code of Maryland; or
(b) A regulation promulgated under Health-General Article,
§21-211, or Title 21, Subtitle 3, Annotated Code of Maryland; or
(2) Fraudulently or deceptively attempts to obtain a license.
D. The Department may suspend or revoke a license if the
licensee:
(1) Violates or fails to meet the requirements of §C of this
regulation; or
(2) Fraudulently or deceptively obtains a license.
E. The Department may deny an application for a food processing
plant license and may suspend or revoke a license pursuant to the provisions
of:
(1) Health-General Article, §§21-211, 21-311, and 21-314—21-317,
Annotated Code of Maryland; and
(2) State Government Article, §10-226, Annotated Code of
Maryland.
F. The person-in-charge shall ensure that:
(1) Food is not processed without the license required by
Health-General Article, §21-305, Annotated Code of Maryland;
(2) The required food processing license is conspicuously posted
in the plant; and
(3) The processing operations in the plant are limited to the
food type or types specified on the license pursuant to §B of this regulation.
G. Except as provided in §H of this regulation, a license may
not be transferred from one person to another person or from one food
processing plant to another.
H. On the death of a licensee, the approving authority may
transfer a food processing plant license if:
(1) An application is filed in accordance with Health-General
Article, §21-306, Annotated Code of Maryland; and
(2) Written evidence establishes that the applicant’s
relationship with the deceased was as a:
(a) Spouse of the deceased licensee;
(b) Blood relative to the first degree of consanguinity; or
(c) Current officer or surviving partner in the business
operating the food processing plant.
.20 Inspections.
A. The person-in-charge shall permit a representative of the
Department to:
(1) Enter a food processing plant at a reasonable time for the
purpose of making inspections to determine compliance with this chapter; and
(2) Examine the records of the facility that pertain to
information regarding food and supplies:
(a) Purchased;
(b) Received;
(c) Manufactured;
(d) Sold; or
(e) Distributed.
B. The person-in-charge shall inform the Department of a food
ingredient or a recipe that the person-in-charge considers a trade secret,
except as provided in §C of this regulation.
C. The person-in-charge shall provide information to the
Department regarding a food ingredient or recipe that the person-in-charge
considers a trade secret if:
(1) An immediate and substantial danger to public health exists
involving the food ingredient or recipe; or
(2) The Department determines that the information about the
food ingredient or recipe is necessary to conduct a foodborne disease
investigation.
D. The person-in-charge shall ensure that:
(1) Compliance with this chapter is continuous;
(2) Violations are corrected within the time for correction
given by the Department;
(3) When a violation of a critical item exists:
(a) The violation is corrected immediately;
(b) Food processing affected by the critical item violation
ceases; or
(c) The food processing plant is closed immediately; and
(4) For a food processing plant that operates seasonally or
intermittently, inspection and regulation by the Department is facilitated by
notifying the Department of:
(a) The dates and times of operation; or
(b) Information necessary to ensure that the Department has the
opportunity to inspect the food processing plant during plant operation.
E. The Department shall maintain the confidentiality of trade
secret information in accordance with General Provisions Article, §4-335, and
Health-General Article, §21-259, Annotated Code of Maryland.
F. When an inspection of a food processing plant is made, the
Department shall:
(1) Complete an inspection report that identifies the:
(a) Conditions found that violate the provisions of this
chapter; and
(b) Critical item violations, noted separately from all other
violations;
(2) Provide a copy of the inspection report to the
person-in-charge of the plant; and
(3) Make the completed inspection report form available for
public disclosure in accordance with General Provisions Article, §§4-101—4-104,
4-201—4-206, 4-301—4-362, and 4-501—4-503, Annotated Code of Maryland.
G. The Department shall ensure that a food processing plant is
inspected:
(1) As determined by the Department or by statute for the
enforcement of this chapter;
(2) At a minimum of the frequency required by COMAR 10.15.07.01
for any shellfish:
(a) Shucker-packer; or
(b) Repacker;
(3) At a minimum of two times per year for any shellfish:
(a) Shipper; or
(b) Reshipper;
(4) At another frequency for shellfish required by COMAR
10.15.07.01; or
(5) When a:
(a) High priority plant, at a minimum of once per 12 months;
(b) Moderate priority plant, at a minimum of once per 24 months;
and
(c) Low priority plant, at a minimum of once every 36 months.
.21 Enforcement.
A. The approving authority shall ensure that when a food
processing plant is found in violation of any provision of this chapter, the
licensee is notified:
(1) Of the specific:
(a) Findings; and
(b) Date by which the licensee shall correct the violations or
deficiencies; and
(2) That, if the licensee fails to correct the violation by the
date specified, the approving authority may suspend or revoke the license.
B. When a person is violating any provision of this chapter, the
approving authority may serve the person with a written order pursuant to
Health-General Article, §21-261 or 21-318, Annotated Code of Maryland,
directing the person to abate the violation within a specified time period.
C. The approving authority shall ensure that an opportunity for
a hearing is provided to a person served with an order, pursuant to State
Government Article, Title 10, Subtitle 2, Annotated Code of Maryland.
D. In order to preserve a right to a hearing under any provision
of this regulation, a person shall:
(1) Make a request for a hearing in writing; and
(2) Submit the request to the approving authority that issued
the order or inspection report:
(a) Within 10 days of receipt of the order;
(b) Sooner if specified in the order; or
(c) Within 24 hours if the violation requires immediate
correction or correction within 24 hours.
E. The approving authority shall suspend or revoke the license
of a food processing plant if the licensee fails or neglects to:
(1) Correct a:
(a) Violation within the specified time period; or
(b) Violation of a critical item immediately; or
(2) Comply with an approved written schedule of compliance.
F. The approving authority shall ensure that:
(1) An action to suspend or revoke a license, complies with the
provisions of:
(a) State Government Article, Title 10, Subtitle 2, Annotated
Code of Maryland; and
(b) Health-General Article, §21-315, Annotated Code of Maryland;
and
(2) The person against whom the action is contemplated is given
an opportunity for a hearing in accordance with Health-General Article,
§21-316, Annotated Code of Maryland.
G. When an immediate and substantial danger is found to exist to
public health, safety, or welfare that imperatively requires emergency action,
pursuant to State Government Article, §10- 226(c)(2), Annotated Code of
Maryland, the:
(1) Approving authority shall:
(a) Summarily suspend the license at the food processing plant;
(b) Order the food processing plant to cease operation
immediately; and
(c) Promptly provide the licensee with:
(i) A written notice of suspension of the license;
(ii) The reasons for the suspension; and
(iii) Instructions on requesting an administrative hearing if
desired; and
(2) Person-in-charge shall immediately cease the operation of
the food processing plant.
H. The person-in-charge shall ensure that a food processing
plant that has been required under the provisions of this regulation to cease
operations does not resume operations until a reinspection by the approving
authority shows that the condition or conditions responsible for the
requirement to cease operations no longer exist.
I. The approving authority shall confirm that appropriate steps
are taken to ensure that the licensee ceases operation of the food processing
plant on suspension or revocation of the license, including:
(1) Taking and keeping physical possession of the license until
the license is reinstated; and
(2) Posting a sign on the facility door stating that the license
has been suspended or revoked by the approving authority.
J. A person whose food processing plant license has been
suspended or revoked may apply for reinspection and reinstatement of the
license by submitting to the approving authority a written request that details
the actions taken by the person to correct each violation of a food statute or
regulation that caused the suspension or revocation.
.22 Foodborne Disease
Investigation and Control.
The approving authority shall ensure that:
A. When there is reasonable cause to suspect foodborne disease
transmission or an outbreak from a food processed or distributed by a food
processing plant, an inspection of the plant is conducted to:
(1) Identify:
(a) Potential points of food contamination in the facility;
(b) Whether employee illness may have contributed; and
(c) Whether a contaminated ingredient was used to process a
food; and
(2) Determine if affected food has been distributed into
commerce; and
B. The appropriate follow-up action is taken, which may include
immediate:
(1) Closing of the food processing plant, or a portion of the
plant that is used to process the implicated product; or
(2) Exclusion of a suspect employee from all food handling
positions within the plant until medical and epidemiological evidence shows
that the likelihood of further foodborne disease transmission is low in
accordance with COMAR 10.06.01.
.23 Traceability, Sampling, and Detention.
A. The person-in-charge shall ensure that:
(1) Records are maintained that allow for traceability of food
or food ingredients received by the food processing plant that include the:
(a) Date received; and
(b) Previous source’s:
(i) Name;
(ii) Address; and
(iii) Contact information;
(2) Records are maintained that allow for traceability of food
and food ingredients that identify the initial distribution of the food that
include:
(a) The date the food was released;
(b) A lot code number or other identifier, if available;
(c) The type of food released, including brand name and specific
variety; and
(d) For the transporter of the food and the intended immediate
recipient, the:
(i) Name;
(ii) Address; and
(iii) Contact information;
(3) All records maintained that allow for traceability are made
available to the Department for review and copying upon request; and
(4) The collection of food and environmental samples by the
Department is allowed in accordance with Health-General Article, §§21-249 and
21-251, Annotated Code of Maryland.
B. The Department shall:
(1) Collect food and environmental samples as often as necessary
for enforcement of this chapter;
(2) Sample food in accordance with Health-General Article,
§§21-249 and 21-251, Annotated Code of Maryland; and
(3) Take action on a food where indicated in accordance with
Health-General Article, §§21-211, 21-253, and 21-254, Annotated Code of
Maryland, by:
(a) Issuing a detention order;
(b) Seeking voluntary destruction; or
(c) Filing a petition for an order of forfeiture for
destruction.
LAURA HERRERA SCOTT
Secretary of Health
Subtitle 35 POSTMORTEM EXAMINERS
COMMISSION
10.35.01 Medical Examiner
Cases
Authority: Health-General Article, §§5-306(e)––5-307, Annotated
Code of Maryland
Notice of Proposed Action
[23-342-P]
The Secretary of Health proposes to amend Regulation .20
under COMAR 10.35.01 Medical Examiner Cases.
Statement of Purpose
The purpose of this action is to update current regulations to
meet current practice standards and ensure essential services needed to comply
with statutory and regulatory obligations of the Office of the Chief Medical
Examiner. Specifically, this proposal increases death scene transportation fees
for service to compensate for a rate comparable to industry standard.
Estimate of Economic Impact
I. Summary of Economic Impact. This proposal increases body
transportation reimbursement fees by 6 percent per mile from $3.30 to $3.50 per
mile, includes a $100 scene response fee, and increases the minimum payment
from $100 to $200 per transport to OCME.
A study concluded that mortuary transportation service providers
are paid significantly lower fees for transport from the State than fees paid
by funeral homes. Due to increased case volume, increased risk of injury
associated with death investigations, and low compensation, the OCME has been
unable to retain qualified mortuary transportation service providers. Lack of
retained transport providers results in delayed scene transport time. These
delays have a direct impact on local EMS/police resources as well as the
community at large. This increase would assist with the recruitment and
retention of mortuary transportation service providers.
II. Types of Economic Impact.
|
Impacted Entity
|
Revenue
(R+/R-)
Expenditure
(E+/E-)
|
Magnitude
|
|
A. On issuing agency:
|
|
|
|
Maryland Department of
Health: Body Transportation
|
(E+)
|
$485,950
|
|
B. On other State agencies:
|
NONE
|
|
|
C. On local governments:
|
NONE
|
|
|
|
|
|
|
|
Benefit
(+)
Cost
(-)
|
Magnitude
|
|
D. On regulated industries or
trade groups:
|
|
|
|
Mortuary transportation
service
|
(+)
|
$485,950
|
|
E. On other industries or
trade groups:
|
NONE
|
|
|
F. Direct and indirect
effects on public:
|
NONE
|
|
III. Assumptions. (Identified by Impact Letter and Number
from Section II.)
A. (1) The proposed action would increase the rate for service
paid to mortuary transportation service providers by 6 percent from $3.30 per
mile to $3.50 per accepted transport and include a $100 scene response fee.
Mortuary transportation service providers have not had an increase since 2014
when the mileage per transport increased from $3.00 to $3.30. The proposed
action would increase the minimum rate for service paid to mortuary
transportation service providers from $100 to $200. Mortuary transportation
service providers have not had a flat rate increase since 2008.
(2) The impact for FY 2024 is estimated to be $97,190, and the
impact for FY 2025 is estimated to be $388,760, resulting in a total impact of
$485,950.
D. See A above.
Economic Impact on Small Businesses
The proposed action has a meaningful economic impact on small
businesses. An analysis of this economic impact follows:
The OCME uses approximately 20 mortuary transportation service
providers throughout Maryland. All of the mortuary transportation service
providers are small businesses, and the proposed increase of death scene
transportation compensation would bring the small business compensation to the
industry standard.
Impact on Individuals with Disabilities
The proposed action has no impact on individuals with
disabilities.
Opportunity for Public Comment
Comments may be sent to Jourdan Green, Director, Office of
Regulation and Policy Coordination, Maryland Department of Health, 201 West
Preston Street, Room 512, Baltimore, MD 21201, or call 410-767-6499 (TTY
800-735-2258), or email to mdh.regs@maryland.gov. Comments will be accepted
through April 8, 2024. A public hearing has not been scheduled.
.20 Body Transportation Reimbursement.
A.—E. (text unchanged)
F. Payment.
(1) Providers of body transportation services shall be paid as
provided in the State budget, [$3.30] $3.50 per mile, one
way, plus any tolls, and a scene response fee of $100, with a minimum
total payment of [$100] $200 from the scene of death to a
designated location. The mileage shall be verified by the OCME.
(2)—(5) (text unchanged)
LAURA HERRERA SCOTT
Secretary of Health
Title 14
INDEPENDENT AGENCIES
Subtitle 31 OFFICE FOR CHILDREN
14.31.04 Rate Setting for
Child Care Providers
Authority: [Article 41, §§6-101 and
6-104; Article 83C, §§2-102, 2-104,
2-113, 2-120, and 2-123—2-125;] Education Article, §§2-206 and
8-417; Family Law Article, §§5-506, 5-507, and 5-509; Health-General
Article,
§§2-102, 2-104, 2-105, 7-306.1, 10-516,
10-902, 10-1203, and 15-102.1; Human Services Article, §§2-209 and 9-231;
Annotated Code of Maryland
Notice of Proposed Action
[24-018-P]
The Department of Human Services proposes to amend Regulations .01,
.02, and .04, repeal existing Regulations .03 and .05—.10,
and adopt new Regulations .03 and .05—.09 under COMAR14.31.04
Rate Setting for Child Care Providers. This action was considered at an open
meeting held pursuant to General Provisions Article, §3-302(c), Annotated Code
of Maryland.
Statement of Purpose
The purpose of this action is to facilitate the establishment of
classes of direct care and clinical care, the determination of rates for
residential child care (RCC) programs based on such classes, and an updated
rate setting methodology. The revisions apply to residential child care
services licensed by the Department of Human Services, the Department of
Juvenile Services, the Maryland Department of Health, and any State department.
Estimate of Economic Impact
I. Summary of Economic Impact. There will be an economic
impact on residential child care (RCC) providers due to increased rate
reimbursements and improved class-based rate settings that opens the
possibility for Medicaid reimbursement.
II. Types of Economic Impact.
|
Impacted Entity
|
Revenue
(R+/R-)
Expenditure
(E+/E-)
|
Magnitude
|
|
A. On issuing agency:
|
|
|
|
Department of Human Services
|
(E+)
|
Unknown
|
|
B. On other State agencies:
|
NONE
|
|
|
C. On local governments:
|
NONE
|
|
|
|
|
|
|
|
Benefit
(+)
Cost
(-)
|
Magnitude
|
|
D. On regulated industries or
trade groups:
|
|
|
|
Residential child care
|
(+)
|
Unknown
|
|
E. On other industries or
trade groups:
|
NONE
|
|
|
F. Direct and indirect
effects on public:
|
NONE
|
|
III. Assumptions. (Identified by Impact Letter and Number
from Section II.)
A. We cannot underestimate the impact that such proposed change
will have on existing litigation as progress on these matters has been stalled
for nearly 2 decades. The text of the proposed regulation amendments was
drafted in close coordination with DHS’ Office of Attorney General as well as
the Offices of Attorney General in the Maryland Department of Juvenile Services
(DJS), Maryland Department of Health (MDH), the Maryland State Department of
Education (MSDE), and the Chair of the Interagency Rates Committee (IRC).
D. The proposed regulation changes will reduce the number of
differentiated provider rates—currently at approximately 97—to a group of six
discrete class categories;
Economic Impact on Small Businesses
The proposed action has a meaningful economic impact on small
businesses. An analysis of this economic impact follows:
The updated rate methodology for determining provider rates will
have a meaningful impact on RCC providers that are small businesses, including
impacts due to the effect of newly defined staffing ratios that support child
and worker safety and well-being; compensation for the provider workforce with
living and competitive wages consistent with their training and expertise; and
standardized rates based on the costs to provide high quality, direct clinical,
behavioral, and therapeutic services, supports, and interventions 24 hours per
day.
Impact on Individuals with Disabilities
The proposed action has an impact on individuals with disabilities
as follows:
The proposed action will have an impact on children and youth
diagnosed with disabilities who require
residential services and supports from Residential Child Care (RCC) providers.
Opportunity for Public Comment
Comments may be sent to Vincent Pacheco, Government Affairs
Administrator, Department of Human Services, 311 West Saratoga St., Baltimore,
MD 21201, or call 443-401-7171, or email to vincent.pacheco@maryland.gov.
Comments will be accepted through April 8, 2024. A public hearing has not been
scheduled.
.01 Scope.
This chapter outlines the
requirements for the determination of rates for the following services
purchased by the departments for children:
A. Residential services
licensed by:
(1) The Department of
Human Services[, under COMAR 07.02.13];
(2) The Department of
Juvenile Services[, under COMAR 14.31.05—14.31.07];
(3) The Maryland
Department of Health[, under COMAR 10.21.07]; or
(4) Any State department;
B. Nonresidential services
in programs approved or accredited by the Maryland State Department of
Education, under COMAR 13A.09.10, or the Department of Juvenile Services [under
COMAR 16.04.05]; and
C. Out-of-State services
from providers licensed, accredited, certified, or approved by the providers'
respective states and approved for placement by the departments described in
Regulation [.02] .02B(9) of this chapter.
.02 Definitions.
A. (text unchanged)
B. Terms Defined.
(1) (text unchanged)
(2) "Allowable variance" means less than or equal to plus
one standard deviation from the mean as determined by the factors and
methodology outlined in the Manual defined in [§B(7)] §B(11) of
this regulation.
(3) “Child placement agency” means a private agency licensed by
the Department of Human Services to receive and place children in foster homes,
treatment foster homes, and independent living arrangements.
[(3)] (4) "Children's Cabinet" means
those agencies [directed by Executive Order:
(a) To examine Maryland's system of services to children and their
families; and
(b) To facilitate ongoing improvements to this service delivery
system] listed under Executive Order 01.01.2024.05C.
(5) “Class Guidelines” means the Class Determination Guidelines
for Residential Child Care Programs, which are maintained and updated, as necessary, by the Committee.
[(4)] (6) “Committee” means the Maryland
Interagency Rates Committee, consisting of[:
(a) An] an individual or individuals representing:
[(i)] (a)—[(v)] (e) (text
unchanged)
[(vi)] (f) The Governor’s Office for
Children[;].
[(b) One representative of a local department of social
services; and
(c) One representative of a local education agency.]
[(5)] (7) "Cost Guidelines" means
the Cost Guidelines for [Residential Child Care Facilities (October,
1999 revision), which is incorporated by reference] Child Placement
Agencies, Education Programs, and Non-Residential Programs, which are
maintained and updated, as necessary, by the Committee.
(8) “Days” means calendar days, unless otherwise specified.
[(6)] (9) (text unchanged)
[(7) "Office" means the Governor's Office for
Children.]
(10) “Educational program” means a program approved under COMAR
13A.09.10 as a nonpublic general education school to operate in conjunction
with residential or nonresidential child care program licensed or approved by
the Department of Health, Department of Human Services, or Department of
Juvenile Services.
[(8)] (11) "Manual" means the [Budget
Preparation and Rate Setting Methodology for Child Care Facilities Manual
(April 1997), which is incorporated by reference] Rate Setting
Methodology Manual for Providers, which is maintained and updated, as
necessary, by the Committee.
[(9)] (12) (text unchanged)
(13) “Nonresidential program” means a community nonresidential
youth program that serves youth served by the Department of Juvenile Services
and is not otherwise licensed or certified by the State.
[(10)] (14) (text unchanged)
[(11)] (15) "Provider" means an
entity licensed, approved, accredited, or certified to provide services to
children and adolescents within:
(a) Maryland under:
(i) COMAR [07.02.13] 07.05.01;
(ii)—(iv) (text unchanged)
(b)—(c) (text unchanged)
(16) “Provider Instructions” means the Interagency Rates
Committee Provider Instructions, which are maintained and updated, as
necessary, by the Committee.
[(12)] (17) "Rate" means [the
cost per unit of service] the daily reimbursement for services
provided to children in residential child care programs and other specified
programs.
[(13)] (18) "Rate Section" means the
Rate Section at the Maryland State Department of Education[, Rate
Setting Structures Section].
(19) Residential Child Care Program.
(a) “Residential child care program” means an entity that
provides for children 24-hours per day within a structured set of services and
activities that are designed to achieve specific
objectives relative to the needs of the children served and that include the
provision of food, clothing, shelter, education, social services, health,
mental health, recreation, or any combination of these services and activities.
(b) “Residential child care program”
includes a program:
(i) Licensed by the Department of Health, the Department of
Human Services, or the Department of Juvenile Services; and
(ii) Subject to the requirements of the Governor’s Office of
Children governing operations of residential child care programs.
[(14)] (20) (text unchanged)
.03 Rate Setting Methodology.
A. The Committee shall develop and maintain a rate setting
methodology for reimbursing specified providers.
B. Cost-Based Methodology.
(1) Child placement agencies, educational programs, and
nonresidental programs shall receive a rate based on a cost-based methodology.
(2) The cost-based methodology determines a rate based on an
individual provider’s budget, including, but not limited to:
(a) Management and general services;
(b) Direct services;
(c) Education services;
(d) Medical services; and
(e) Clinical services.
(3) The rate determination shall be calculated using:
(a) An individual program budget application;
(b) A mean annual rate for a specified program category; and
(c) A direct care cost comparison metric.
(4) The cost-based methodology is contained in the Manual and
the Cost Guidelines, which are published on the Maryland State Department of
Education website.
C. Class-Based Methodology.
(1) Residential child care programs shall receive a rate based
on a class-based methodology.
(2) The class-based methodology determines a rate based on the
level of services provided by the residential child care program.
(3) The Committee shall determine the level of services the
residential child care program must provide to meet the requirements of each
class as defined by the Committee.
(4) Each class is assigned a flat rate by the Committee.
(5) The class-based methodology is contained in the Manual and
the Class Guidelines, which are published on the Maryland State Department of
Education website.
.04 [Application for] Rates Determination Application.
A. Renewal [Rates] Rate Application and
Submission.
(1) The Rate Section shall [provide budget instructions
] distribute the Provider Instructions and applications for
determinations of renewal rates to in-State and out-of-State providers whose programs
previously received an approved rate from the [State] Committee
by December 31 of each year.
(2) [Providers] Except as provided in §A(3) of
this regulation, providers shall submit an application to the Rate
Section for a renewal rate determination[, in accordance with this
chapter,] by February 15 of each year[.] in accordance
with this chapter.
(3) For fiscal year 2025, residential
child care programs shall submit an application to the Rate Section by July 31,
2024, for a class-based rate, consistent with the Provider Instructions and
Regulation .03C of this chapter.
B. New [Rates] Rate Application
and Submission.
(1) On written request by a provider, the Rate Section shall
[provide budget instructions] distribute the Provider
Instructions and applications for a rate determination for in-State
and out-of-State providers whose programs have not previously received an
approved rate from the [State] Committee.
(2) Providers shall submit to the Rate Section an application for a
rate for new [residential or nonpublic educational] programs
before anticipated licensure, [accreditation,] certification, or
approval.
C. Out-of-State Providers.
(1) [A] An out-of-State provider that [provides
services in a licensed out-of-State facility which has a rate established by
the authorized rate-setting body of the State in which services are provided
shall submit documentation to the Committee of the rates established by the
authorized rate-setting body of their respective state, if applicable, instead
of an application] does not have a rate established in the
state in which services are provided may submit an application in accordance
with this regulation.
[(2) An out-of-State provider that does not have a rate
established in the State in which services are provided may submit an
application in accordance with Regulation .04A or B of this chapter.]
(2) A provider that provides services in a licensed out-of-State
facility which has a rate established by the authorized rate-setting body of
the state in which the facility is located shall submit documentation to the
Committee of the rates established by the authorized rate-setting body of their
respective state, if applicable, instead of an application.
D. Conformance with Manual, Cost and Class Guidelines, and Provider
Instructions. Provider applications shall conform to the requirements set
forth in the Manual, Cost and Class Guidelines, as appropriate, and the
Provider Instructions.
.05 Rate Determination, Approval, and Notification.
A. Use of Guidelines.
(1) Rates for child placement agencies, educational programs,
and nonresidential programs shall be determined, excluding unallowable costs,
consistent with the Cost Guidelines.
(2) Rates for residential child care programs shall be
determined consistent with the Class Guidelines.
B. Review of Application. After review of a rate application,
the Committee shall take one of the following actions:
(1) Approve the rate requested in the application;
(2) Return the application to the provider, requesting that
additional information or changes to the application be resubmitted within 10
business days; or
(3) Deny the rate requested in the application and issue a
revised rate.
C. Notification of Approved Renewal Rates.
(1) Except as otherwise provided in §C(2) of this regulation,
the Committee shall notify providers of their approved rates for applications
timely submitted that meet the requirements of the Provider Instructions by
June 15 of each year.
(2) For fiscal year 2025, the Committee shall notify residential
child care programs that submit a timely and complete application to the Rate
Section, consistent with Regulation .04A(3) of this chapter, by September 15,
2024.
D. Notification of Approved New Rates. The Committee shall
review applications, submitted in conformance with the Provider Instructions,
and make a rate determination for new programs within 60 days of receipt. Rate
determinations are not final until issuance of a license or accreditation.
E. Effective Dates for Rates.
(1) Except as otherwise provided in §E(2) of this regulation,
renewal rates shall be in effect at the start of the State fiscal year and
remain in effect until the end of that State fiscal year.
(2) For fiscal year 2025, rates approved by the Committee for
residential child care programs consistent with §C(2) of this regulation shall
be in effect October 1, 2024, and remain in effect until June 30, 2025.
(3) Rates for new child placement agencies, educational
programs, and nonresidental programs issued after March 31 of each State fiscal
year shall remain in effect until June 30 of the following State fiscal year.
F. Determination of Preferred Providers.
(1) The Committee shall categorize child placement agencies
according to service type and, when appropriate, capacity.
(2) The Committee shall use the methodology in the Manual to
determine approved rates within each category and determine preferred
providers.
G. The Committee shall publish, annually, a list of all
providers and approved rates and shall issue quarterly supplements with changes
and additions. Child placement agencies shall be designated as preferred or
nonpreferred in the listings, in accordance with the Committee's determination.
H. Conformance with Federal Laws. Rates shall be determined in
conformance with relevant federal requirements, including Title IV-E of the
Social Security Act.
I. Cost Containment. The Committee may impose cost containment
measures to bring the rate structure into conformity with the budget
appropriations approved by the General Assembly, and nothing in the Manual,
Cost and Class Guidelines, or Provider Instructions shall preclude the
implementation of cost containment.
.06 Reconsideration of a Committee Determination.
A. A provider may request reconsideration of a Committee
determination made under Regulation .05 of this chapter.
B. The Rate Section shall act on behalf of the Committee to
receive and process requests for reconsideration.
C. A provider seeking reconsideration of a determination shall
file a written request with the Rate Section. The request is to be filed within
30 days of the provider's receipt of notice of the Committee's determination.
D. The Rate Section shall review each request for
reconsideration to determine if it provides sufficient information to complete
analysis of the request.
E. Each request for reconsideration shall include detailed
information regarding:
(1) The relief requested; and
(2) The basis for the relief.
F. If a request for reconsideration does not include sufficient
information for review, the Rate Section shall provide written notice to the
provider listing all information required to complete the review.
G. If the provider fails to provide the additional required
information within 45 days of receipt of the Rate Section notice, the Rate
Section shall void the provider's request for reconsideration.
H. Review by the Committee. Within 30 days of receipt of a
complete request for reconsideration from the provider, the Committee shall
provide written notification to the provider of its decision to:
(1) Grant the request.
(2) Grant the request with modification; or
(3) Deny the request.
I. A reconsideration of a determination by the Committee under
this chapter is not a contested case within the meaning of State Government
Article, Title 10, Subtitle 2, Annotated Code of Maryland.
.07 Appeals.
A. Filing of an Appeal.
(1) A provider may appeal to the Children's Cabinet the
Committee's decision regarding a request for reconsideration made under
Regulation .06 of this chapter.
(2) The provider shall file a written appeal with the Rate
Section within 30 days of the provider's receipt of the Committee's decision
regarding the request for reconsideration.
(3) The appeal shall set forth the specific objections to the Committee's
decision regarding the request for reconsideration.
B. Rate Section Requirements. Upon receipt of an appeal, the
Rate Section shall:
(1) Forward the appeal to the Children's Cabinet or its
designee; and
(2) Provide to the Children's Cabinet a copy of the record upon
which the Committee's decision regarding the provider's request for
reconsideration was based, including:
(a) The provider's written request for a reconsideration; and
(b) Any supporting documentation.
C. Review by the Children's Cabinet. Within 30 days of receipt
of an appeal from the provider, the Children's Cabinet or its designee shall:
(1) Review the written appeal and the record provided by the
Rate Section;
(2) Request additional information, if needed, from the provider
or the Rate Section; and
(3) Issue a final, binding opinion upholding, modifying, or
reversing the rate set by the Committee.
D. An appeal to the Children's Cabinet is not a contested case
within the meaning of State Government Article, Title 10, Subtitle 2, Annotated
Code of Maryland.
.08 Modification of a Committee Determination.
A. Request for Modification. A provider may request a
modification of a current Committee determination during the State fiscal year
under the following conditions:
(1) To address health and safety issues which arise after the
annual rate process;
(2) To address an emergency situation, such as fire or natural
disaster;
(3) To address corrective action issues requested by the
licensing agency or by a placing agency in conjunction with the licensing
agency; or
(4) To address a program modification requested by a licensing
or placing agency.
B. The Rate Section shall act on behalf of the Committee to
receive and process requests for modifications.
C. A provider seeking modification of a determination shall file
a written request with the Rate Section.
D. The Rate Section shall review each request for modification
to determine if it provides sufficient information to complete analysis of the
request.
E. Each request for modification shall include detailed
information regarding:
(1) The relief requested; and
(2) The basis for the relief.
F. If a request for modification does not include sufficient
information for review, the Rate Section shall provide written notice to the
provider listing all information required to complete the review.
G. If the provider fails to provide the additional required
information within 45 days of receipt of the Rate Section notice, the Rate
Section shall void the provider's request for modification.
H. Review by the Committee. Within 30 days of receipt of a
complete request for modification from the provider, the Committee shall
provide written notification to the provider of its decision to:
(1) Grant the request;
(2) Grant the request with modification; or
(3) Deny the request.
I. A modification of a determination by the Committee under this
chapter, or an appeal to the Children's Cabinet, is not a contested case within
the meaning of State Government Article, Title 10, Subtitle 2, Annotated Code
of Maryland.
.09 Interagency Rates Committee Advisory Committee.
A. An Advisory Committee to the Interagency Rates Committee,
composed of parents, advocates, and providers, shall be appointed by the
Children's Cabinet. The Advisory Committee may recommend and review policies
and procedures regarding rate setting and provide information regarding the
impact of rates on children, facilities, providers, and the business community.
B. The Advisory Committee shall meet periodically.
RAFAEL LÓPEZ
Secretary of Human Services
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