Code of Maine Rules
10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES
144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL
Chapter 201 - HEALTH INSPECTION PROGRAM ADMINISTRATION RULE
Section 144-201-6 - INSPECTIONS
Universal Citation: 10 ME Code Rules ยง 144-201-6
Current through 2024-38, September 18, 2024
A. Right of Entry
1. Licensed Establishments: The Department
and any duly designated officer or employee of the Department shall have the
right to enter upon and into the premises of any licensed establishment,
without an administrative inspection warrant, at any reasonable time, in order
to determine the state of compliance with any rules in force, in accordance
with 22
MRS §§2497 and
2667.
2. Unlicensed Establishments: The Department
may enter and inspect any premises of an unlicensed establishment with the
permission of the owner or person in charge. In the event that a person in
charge of the unlicensed establishment denies access to the Department, the
Department may secure access through an administrative search warrant or
pursuant to such process as provided by law.
B. Frequency
1. In accordance with
22 MRS
§§
2497 and
2667, the Department will either
inspect or otherwise determine whether an establishment is in regulatory
compliance, in accordance with the provisions of this rule. Based on the result
of these routine inspections, the Department may increase frequency for
establishments from every two years to more frequent inspections, based on the
following criteria:
a.
Quarterly
inspections: The Department's finding of the following factors will
increase inspection frequency for an establishment, from a minimum of every two
years to quarterly, for a period of one year:
i. Two failed inspections occurred within one
year of each other;
ii. Three
failed inspections under the same owner occurred within the past five
years;
iii. Other uncorrected
health hazards occurred, where the Department required correction of such
health hazards; or
iv. Any other
conditions posing a risk to public health and safety.
b.
Monthly inspections: The
Department will increase the frequency of inspections from quarterly to
monthly, for a period of four months, if, after being placed on a quarterly
inspection frequency, (due to findings in Section
6(B)(1)(a) above):
i. The establishment failed an inspection
during that year of quarterly inspections;
ii. The establishment failed to correct
health hazards as required by the Department; or
iii. The establishment demonstrates other
conditions posing a risk to public health and safety.
2. The Department may, at its
discretion, inspect or determine whether an establishment is in regulatory
compliance at more frequent intervals, as necessary, to follow-up on complaints
or other issues noted on previous inspections. At a minimum frequency, the
Department will inspect Category 1, 2, or 3 eating establishments at least once
every 24 months. Any eating establishment may be assigned more or less frequent
inspections, based on a risk-based assessment that includes the following
factors:
a. Category 1: Classified as
low-risk, includes those establishments with the following criteria:
i. Serve or sell only pre-packaged,
non-potentially hazardous foods;
ii. Prepare only non-potentially hazardous
foods;
iii. Heat only commercially
processed, potentially hazardous foods for hot holding; and/or
iv. Does not cool any potentially hazardous
foods.
b. Category 2:
Classified as medium risk, includes those establishments with the following
criteria:
i. Most products are prepared/cooked
and served immediately;
ii. May
involve hot and cold holding of potentially hazardous foods after preparation
and cooking; and/or
iii. Complex
preparation of potentially hazardous foods requiring cooking, cooling, and
reheating for hot holding is limited to five or fewer potentially hazardous
foods.
c. Category 3:
Classified as high risk, includes those establishments with the following
criteria:
i. Extensive menu and handling of
raw ingredients;
ii. Complex
preparation, including cooking, cooling and reheating for hot holding, involves
more than five potentially hazardous foods; and/or
iii. Variety of processes require hot and
cold holding of potentially hazardous food.
d. Category 4: Classified as highest risk
include those establishments with the following criteria:
i. Serve a highly susceptible population who
include, but are not limited to, immune-compromised, pre-school children and
the elderly; or
ii. Conduct
specialized processes, including but not limited to, smoking and curing;
reduced oxygen packaging for extended shelf life, HACCP; or a
variance.
3.
Criteria for returning to standard, routine inspection frequency.
The Department will review the following factors to determine whether the
establishment may return to a less frequent inspection frequency:
a. Monthly to quarterly inspections: When an
establishment is subject to monthly inspections for a four-month time period
(due to factors in Section
6(B)(1)(b) above) and
the establishment passes those monthly inspections for all four consecutive
months with no repeat critical violations within the period of increased
inspection frequency, then the Department may reduce inspection frequency of
the establishment to two quarterly inspections.
b. Quarterly to biennial inspections: When an
establishment passes quarterly inspections for either one year under Section
6(B)(1)(a) or two
consecutive quarters under Section
6(B)(3)(a) with no
repeat critical violations within the period of increased inspection frequency,
then the Department may reduce inspection frequency to every other
year.
C. Inspection report
1. The
Department's findings are noted on the inspection report and may refer to the
compliance history of an establishment, including any prior violations and
corrective action. The findings shall identify violations by the following
means:
a. Site inspection or complaint
investigation;
b. Review of
laboratory analyses or inspection reports; and/or
c. Complaints or referrals from the public or
other agencies.
2. The
inspection report will note any violations of applicable rules, and the
inspector will provide a copy of the report to the person in charge at the
establishment at the time of the inspection.
a. Should the establishment fail the
inspection, the inspector will inform the person in charge in writing of the
failed inspection, the remedies to correct the violation(s) and deadlines for
corrective action.
b. The licensee
must maintain a copy of the most recent inspection report at the establishment
and make that report available to the public upon request.
i. The Department's inspector will document
details of any denial of access to perform an inspection.
ii. The Department's inspector will ask the
licensee or person in charge to sign the inspection report, acknowledging the
receipt of the inspection report, findings and requirements.
3. When a licensee or
person in charge refuses to sign an acknowledgement of receipt of an inspection
report, the Department will respond by stating the following items to the
licensee or person in charge:
a. An
acknowledgment of receipt does not constitute an agreement with the inspection
report findings;
b. Refusal to sign
an acknowledgment of receipt will not affect the licensee's obligation to
correct the violations noted in the inspection report within the time frames
specified;
c. Refusal to sign an
acknowledgment of receipt is noted in the inspection report and conveyed to the
Department's historical record for the establishment; and
d. Make a final request for the licensee or
person in charge to sign an acknowledgment receipt of inspection findings.
Should the licensee or person in charge continue to refuse to sign, the
inspector will document the refusal upon the inspection report.
D. Inspection failure
1. A failed inspection occurs
when an establishment:
a. Receives more than 3
critical violations; or
b. Receives
more than 10 non-critical violations.
2. Critical violations may be corrected on
site while the inspector remains on site, but, in any event, must be corrected
within 10 calendar days of the site visit. The licensee must notify the
Department when the critical violation has been addressed.
3. Non-critical violations must be corrected
in a period to be determined by the Department, but no later than 30 calendar
days after the inspection. The Department may approve a compliance schedule
that extends beyond the time limits specified in this section, if a written
schedule of compliance is submitted by the licensee and no serious health
hazard exists or will result from allowing an extended schedule for
compliance.
4. Failure to correct
these violations satisfactorily within the time periods set in paragraphs (2)
and (3) above may result in enforcement proceedings by the Department, which
are outlined in Sections
7,
8 and
9 of this rule.
5. Any failed inspection requires the health
inspector to follow up with a later inspection, to ensure that all violations
were corrected by a specified deadline.
E. Imminent health hazards
1. Ceasing operations and reporting. A
licensee shall immediately discontinue operations and notify the Department if
an imminent health hazard (IHH) may exist because of an emergency, such as a
fire, flood, extended interruption of electrical or water service, sewage
backup, misuse of poisonous or toxic materials, onset of an apparent food-borne
illness outbreak, gross unsanitary occurrence or condition, or other
circumstance that may endanger public health.
2. If operations are discontinued, or the
Department has issued an IHH, or a license is temporarily suspended, the
licensee must obtain approval from the Department before resuming
operations.
3. For establishments
with conditions that pose an imminent health hazard if conditions are not
corrected within the time period set by the Department, then the Department may
suspend a license on an emergency basis pursuant to
5 MRS
§10004, or may initiate an action for
license suspension or revocation pursuant to
4 MRS
§184.
4. Specialized food processes. In accordance
with the Maine Food Code (10-144 CMR Ch. 200), eating
establishments that perform specialized food processes, including, but not
limited to, vacuum packaging, cook chill packaging, sous vide packaging,
acidifying foods for preservation, fermenting of vegetables and curing foods,
must develop and implement a hazard analysis critical control point (HACCP)
plan prior to performing these processes. Some of these specialized processes
may also require a variance. Because it is the licensee's responsibility to
develop a HACCP plan, the licensee must contact the Department for guidance
prior to performing any specialized processing.
a. Applicants for a variance must demonstrate
an appropriate level of training and/or experience to process the product
safely;
b. The Department may
mandate a HACCP training course, depending upon the licensee's knowledge,
compliance history and experience with the specialized food processes they are
performing;
c. The development of a
HACCP plan is the responsibility of the licensee; and
d. The Department will review requests for,
and issue variances, on a case-by-case basis for specialized food
processes.
F. Detained or embargoed product
1.
Whenever an inspector finds or has reason to believe that an establishment
licensed by the Department prepares or sells any food that is adulterated or
misbranded, an order detaining or embargoing that food may be issued pursuant
to 22 MRS
§2503.
2. The Department Inspector or an
establishment employee will affix a Hold Tag to the product giving notice that
the product is suspected of being adulterated or misbranded and must not be
removed, sold or disposed of until permission for removal or disposal has been
given by the inspector.
3. The
Department may petition the district court or superior court for a libel for
condemnation of the product if the licensee is unwilling to dispose of the
product.
a. If the court finds that the food
product is not adulterated or misbranded, then the inspector or establishment
employee will remove the Hold Tag.
b. If the court finds that the food product
is adulterated or misbranded, the article must be destroyed at the expense of
the licensee under the supervision of the inspector. All court costs, fees and
storage will be paid by the licensee.
c. When the adulteration or misbranding can
be corrected by proper labeling or processing, with court approval, the
licensee may conduct such labeling and processing under the supervision of the
inspector.
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