105 CMR 590.008 - Compliance and Enforcement

Adopt Chapter 8 "Compliance and Enforcement" of the 2013 Food Code with the following amendments:

(A) After FC 8-103.12 Conformance with Approved Procedures, the following section is added:

"8-103.15 Variances.

In addition to requirements set forth in FC 8-103 Variances:

(A) Any variance granted by the board of health shall be in writing. A copy of any such variance shall, while it is in effect, be available to the public at all reasonable hours in the office of the clerk of the city or town, or in the office of the board of health. Copies of all variances shall be provided to the Director upon request.

(B) Any variance may be subject to such qualification, revocation, suspension, or expiration as the board of health expresses in its grant. A variance may otherwise be revoked, modified, or suspended, in whole or in part, only after the holder thereof has been notified in writing and has been given an opportunity to be heard in conformity with the requirements for an order and hearing in 105 CMR 590.015."

(B) After FC 8-201.14 Contents of a HACCP Plan, the following section is added:

"8-201.20 Plan Approval or Disapproval.

In addition to requirements set forth in FC 8-201 Facility and Operating Plans:

Plan approval shall be granted or denied within 30 calendar days after the submission of said plans. If the board of health does not approve or disapprove said plans within such time, the plans shall be deemed to have been approved. Approval shall be denied only if such plans establish that the proposed food establishment will violate the provisions of 105 CMR 590.000 or other applicable laws, ordinances, or regulations. Disapproval of such plans shall be deemed an order to which the procedure provided in 105 CMR 590.015 shall apply."

(C) In FC 8-303.20 Existing Establishments, Permit Renewal, and Change of Ownership, the entire text is stricken and replaced by the following:

"8-303.20 Existing Establishments, Permit Renewal, and Change of Ownership.

(A) Copies of Permit. The permit shall be made out in duplicate. One copy shall be given to the applicant, and a paper or electronic copy shall be placed on file with the board of health.

(B) Expiration and Renewal of Permit.

(1) A permit shall expire no later than one year from the date issued.

(2) An annual food establishment permit may be renewed by applying at least 30 days prior to the expiration of the permit on a form provided by the FC-regulatory authority.

(C) Conditions for Issuance. The board of health may renew a permit for an existing food establishment or may issue a permit to a new owner of an existing food establishment after a properly completed application is submitted, reviewed, and approved, the fees are paid, and an inspection shows that the establishment is in compliance with 105 CMR 590.000. In the case of a renewal application, the inspection must have been conducted within the time interval established by the board of health pursuant to 8-401.10.

(D) Refusal to Issue a Permit: Grounds and Notice of Refusal. The board of health may refuse to issue a permit, initial or renewal, based on one or more of the following grounds. Each of the following grounds individually or severally shall constitute full and adequate grounds to refuse to issue a permit. The notice of refusal shall provide the grounds upon which the denial is based and shall notify the applicant of the right to a hearing provided in 105 CMR 590.015(B).

(1) Failure to submit a permit application in accordance with the board of health's procedures;

(2) Failure to submit the required permit fee;

(3) Denial of entry of agents of the board of health or the Department or any attempt to impede the work of a duly authorized agent of the board of health or the Department;

(4) Providing false or misleading statements to the board of health or the Department;

(5) The applicant or owner operated the facility without a permit;

(6) The applicant or owner, or if the applicant or owner is a corporation, a corporate officer, of the facility, has been convicted of, plead guilty or no lo contendere to, or has, in a judicial proceeding, admitted facts sufficient to find that the individual is guilty of a crime relating to the processing, storage, distribution or sale of food in connection with the business;

(7) The applicant or owner, or if the applicant or owner is a corporation, a corporate officer, of the facility has engaged in conduct that endangers the public health;

(8) Failure to pay any federal, state, or local taxes as required by law, pursuant to M.G.L. c. 62C, § 49A;

(9) Failure to comply with local regulations/ordinances related to the operation of the facility;

(10) Failure to comply with provisions of 105 CMR 590.000; and

(11) Such other reasons not stated in FC 8-303.20(D)(1) through (10), which pose a risk to public health and safety."

(D) In FC 8-304.10 Responsibilities of the Regulatory Authority, the entire text is stricken and replaced by the following:

"8-304.10 Responsibilities of the FC-regulatory Authority

(A) At the time a permit is first issued, the FC-regulatory authority shall provide to the permit holder instructions on how to obtain 105 CMR 590.000 so that the permit holder is notified of the compliance requirements and the conditions of retention, as specified under 8-304.11, that are applicable to the permit.

(B) Failure to provide the information specified in this section does not prevent the FC-regulatory authority from taking authorized action or seeking remedies if the permit holder fails to comply with 105 CMR 590.000 or an order, warning, or directive of the FC-regulatory authority."

(E) After FC 8-304.11 Responsibilities of the Permit Holder, the following section is added:

"8-304.15 Notification of Changes.

In addition to requirements set forth in FC 8-304.11 Responsibilities of the Permit Holder, the permit holder shall:

(A) Notify the board of health within 48 hours after any change in ownership, and at least 30 days prior to any change of the name, location of the food establishment or addition of a new operation and shall promptly submit to the board of health an application for a new or amended permit, together with written documentation reflecting such change.

(B) Submit plans in accordance with FC 8-2 Plan Submission and Approval any time an establishment is being remodeled or a new operation added and shall promptly submit to the board of health an application if a new or amended permit is required."

(F) After FC 8-304.20 Permits not Transferable, the following section is added:

"8-304.25 Permit Form.

In addition to the requirements set forth in FC 8-3 Permit to Operate:

(A) There shall be one permit form issued to each food establishment. The permit shall indicate:

(1) Whether the permit is annual, semi-annual, seasonal or temporary; and

(2) Each of the following operations permitted:

(a) Food Service (i.e., handling of unpackaged or exposed food intended for individual service such as sit-down and take-out operations in restaurants, sandwich operations in retail markets and convenience stores, coffee and pastry shops, institutional kitchens);

(b) Retail Food (i.e., handling of pre-packaged foods or the handling of unpackaged or exposed food not intended for individual service such as retail grocery and convenience stores which sell pre-packaged foods, seafood and meat markets, bakeries and bulk deli operations);

(c) Residential kitchen for retail sale; cottage foods;

(d) Residential kitchen for bed-and-breakfast;

(e) Mobile/Pushcart;

(f) Temporary food establishment;

(g) Caterer; and/or

(h) Other as described on application.

(B) The permit shall state:

(1) The name and address of the food establishment;

(2) The name of the permit holder;

(3) The date of expiration; and

(4) Any restrictions on the type of operations allowed."

(G) After FC 8-304.25 Permit Form, the following sections are added:

8-304.30 Permit for Nonprofit Distribution.

Pursuant to M.G.L. c. 94, § 328, a nonprofit entity that distributes or serves food without charge or at a charge sufficient to cover the cost of handling the food may not be charged a fee for their food establishment permit.

8-304.35 Pot Luck Events.

A valid permit to operate is not required when a potluck event meets all of the requirements of M.G.L. c. 94, § 328A, including that participants at the event must be informed that neither the food nor the facilities have been inspected by the state or by a local public health agency.

(H) In FC 8-401.10 Establishing Inspection Interval, Subparagraph (B)(2) is stricken and replaced by the following:

"(2) The food establishment is assigned a less frequent inspection frequency based on a written risk-based inspection schedule approved by the Department that is being uniformly applied throughout the jurisdiction and at least once every six months the establishment is contacted by telephone or other means by the FC-regulatory authority to ensure that the establishment manager and the nature of food operation are not changed; provided, however, that the FC-regulatory authority may not increase the interval between inspections beyond six months for any school kitchen; or"

(I) In FC 8-402.10 Competency of Inspectors, the following Paragraphs (C) and (D) are added:

"(C) Any person conducting food inspections for the board of health shall be knowledgeable in food borne disease prevention, application of the hazard analysis critical control point principles, and the requirements of 105 CMR 590.000 as they relate to food establishments in their city or town.

(D) Any individual conducting food inspections shall demonstrate the knowledge referenced in this section by:

(1) Passing a certified food protection manager or certified food safety professional test that is part of an accredited program recognized by the Department and completing food safety inspection training as specified in administrative guidelines of the Department; or

(2) Being a registered sanitarian, a registered environmental health specialist, or a certified health officer who has completed food safety inspection training as specified in administrative guidelines of the Department."

(J) In FC 8-402.11 Allowed at Reasonable Times after Due Notice, the entire text is stricken and replaced by the following:

"8-402.11 Allowed at Reasonable Times after Due Notice.

No prior notice of an inspection is required so long as the FC-regulatory authority presents official credentials and provides notice of the purpose of, and an intent to conduct, an inspection, the person in charge shall allow the FC-regulatory authority to determine if the food establishment is in compliance with 105 CMR 590.000 by allowing access to the establishment, allowing inspection, and providing information and records specified in 105 CMR 590.000 and to which the FC-regulatory authority is entitled according to law, during the food establishments hours of operation and other reasonable times."

(K) In FC 8-403.10 Documenting Information and Observations, the entire text is stricken and replaced by the following:

"8-403.10 Documenting Information and Observations.

(A) Whenever an inspection of a food establishment is made, the findings shall be recorded on a printed or electronic inspection report form, which shall summarize the requirements of 105 CMR 590.000 and the 2013 Food Code. A prototype of an inspection form, which meets the requirements of FC 8-403.10 may be obtained from the Department. A board of health may use this form or, subject to approval by the Department, any form consistent with this prototype. Each board of health shall submit the form it adopts to the Department.

(B) If an inspection reveals that a food establishment does not comply with 105 CMR 590.000, the board of health or its agent shall notify the permit holder or person in charge of the violations and shall order the permit holder to correct the violations. The inspection report may, if so stated, constitute an order to correct, or the board of health or its authorized agent may issue a separate order. An order to correct shall include, but need not be limited to the following:

(1) Administrative information about the food establishment and the inspection including, but not limited to:

(a) The food establishment's legal identity, street and mailing addresses, permit holder's name and address, type of establishment and operation as specified under FC 8-302.14(C), inspection date, type of inspection and other information such as type of water supply and sewage disposal, status of the permit, and personnel certificates that may be required;

(b) The name of the inspector;

(c) The date and time of the inspection;

(d) The time frame for correction of the violations as specified under FC 8-404.11, 8-405.11, and 8-406.11;

(e) The signature of a member of the board of health or its agent; and

(f) The signature of the person in charge of the food establishment at the time of the inspection, or other proof of service of the order.

(2) Specific factual observations of violative conditions or other deviations from 105 CMR 590.000, that require correction by the permit holder, including, but not limited, to:

(a) Nonconformance with specific provisions of 105 CMR 590.000;

(b) Failure of the person in charge to demonstrate the knowledge of foodborne illness prevention, application of HACCP principles, and the requirements of the 2013 Food Code as specified in FC 2-102.11;

(c) Failure of food employees and the person in charge to demonstrate their knowledge of their responsibility to report a disease or medical condition as specified in FC 2-201.11;

(d) Failure of the appropriate food employees to demonstrate their knowledge of, and ability to perform in accordance with, the procedural, monitoring, verification, and corrective action practices required by the FC-regulatory authority as specified under FC 8-103.12;

(e) Failure of the person in charge to provide records required by the FC-regulatory authority for determining conformance with a HACCP plan as specified under FC 8-201.14;

(f) Nonconformance with critical limits of a HACCP plan; and

(g) A determination by the inspector whether any of the violations create an imminent health hazard.

(3) A statement that the order when signed constitutes an order of the board of health to correct any violations of 105 CMR 590.000 that are indicated on the order within the time periods designated. It shall be within the discretion of the board of health whether the order shall be signed by the board of health or its agent.

(4) A statement that failure to comply with any time limits for correction may result in suspension or revocation of the food establishment permit and cessation of food establishment operations.

(5) A statement informing the permit holder of his right to a hearing before the board of health, his responsibility to request the hearing in writing within ten days of receipt of the notice, and the address of the board of health.

(C) The FC-regulatory authority shall track the results of each school kitchen inspection and investigation, including any violations and steps to remediate the violations, pursuant to M.G.L. c. 111, § 223(g)."

(L) In FC 8-403.50 Public Information, the entire text is stricken and replaced by the following:

"8-403.50 Public Information

All reports and information collected or received by the Department pursuant to M.G.L. c. 111, § 223(g), completed inspection report forms, and other related enforcement documents are public records as defined in M.G.L. c. 4, § 7 clause 26^th and shall be made available for public disclosure, unless exempted by law, to any person who requests it pursuant to M.G.L. c. 66, § 10. All inspection report forms and other related enforcement documents shall be maintained by the board of health for a minimum of five years or longer if otherwise required by law."

(M) After FC 8-405.20 Verification and Documentation of Correction, the following section is added:

"8-405.25 Food Safety Training

The board of health may issue an order to the permit holder to provide additional food safety training to the person in charge, if after an order for correction has been issued, violations relating to 105 CMR 590.000 interventions and foodborne illness risk factors are documented during a reinspection."

(N) After FC 8-501.20 Restriction or Exclusion of Food Employee, or Summary Suspension of Permit, the following section is added:

" 8-501.25 Department Notification/Investigation and Control.

In addition to requirements in FC 8-501.10 and FC 8-501.20, the board of health shall:

(A) Immediately notify the Department of all confirmed and suspected foodborne illness outbreaks within 24 hours on a form provided by the Department and shall keep the Department informed until the investigation has been completed; and

(B) Take any other action required by 105 CMR 300.000: Reportable Diseases and Isolation and Quarantine Requirements except that FC 8-501.10 shall supersede the Minimum Period of Isolation of Patient established for E. coli O157:H7 and Shigella in 105 CMR 300.200: Isolation and Quarantine Requirements."

(O) In FC 8-501.40 Removal of Exclusions and Restrictions, the entire text is stricken and replaced by the following:

"8-501.40 Removal of Exclusions and Restrictions

The FC-regulatory authority shall release a food employee from restriction or exclusion according to law and the following conditions:

(A) A food employee who was infected with typhoid fever if the food employee's stools are negative for typhoid fever based on testing of at least three consecutive stool specimen cultures that are taken:

(1) Not earlier than one month after onset;

(2) At least 48 hours after discontinuance of antibiotics;

(3) At least 48 hours apart.

(B) If one of the cultures taken as specified in 8-501.40(A) is positive, repeat cultures are taken at intervals of one month until at least three consecutive negative stool specimen cultures are obtained.

(C) A food employee who was infected with Shigella spp. or Shiga Toxin-producing Escherichia coli if the employee's stools are negative for Shigella spp. or Shiga Toxin-producing E. coli based on testing of two consecutive stool specimen cultures that are taken:

(1) Not earlier than 48 hours after discontinuance of antibiotics; and

(2) At least 24 hours apart.

(D) A food employee who was infected with hepatitis A virus if:

(1) The food employee is no longer febrile; or

(2) It has been at least one week since the onset of symptoms."

Notes

105 CMR 590.008

Amended by Mass Register Issue 1375, eff. 10/5/2018.