10-144-201 Me. Code R. § 6

Current through 2024-51, December 18, 2024

Section 144-201-6 - INSPECTIONS

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.

10-144 C.M.R. ch. 201, § 6