Code of Massachusetts Regulations
105 CMR - DEPARTMENT OF PUBLIC HEALTH
Title 105 CMR 500.000 - Good Manufacturing Practices For Food
Administration and Enforcement
Section 500.207 - Grounds for Administrative Enforcement Action

Universal Citation: 105 CMR 500.000 MA Code of Regs 500.207

Current through Register 1531, September 27, 2024

(A) Grounds for Refusal to Issue a License, Permit, or Certification.

(1) The regulatory agency may refuse to issue a license, permit, or certification based on any one or more of the following grounds. Each of the following grounds shall constitute full and adequate grounds to refuse to issue a license or permit.
(a) Failure to submit a timely application in accordance with the regulatory agency's procedures;

(b) Failure to submit the required fee;

(c) Failure to comply with any applicable statute, with any applicable provision of 105 CMR 500.000, or with any lawful order of the regulatory agency or the Commissioner;

(d) Denial of entry to agents of the regulatory agency, or any attempt to impede the work of a duly authorized agent or representative of the regulatory agency;

(e) Providing a false or misleading statement to the regulatory agency, or keeping or submitting any misleading or false records or documents pertaining to the subject business, or failing to keep records required to be kept;

(f) The applicant operated the business or any business without a required license or permit or after the expiration of the same;

(g) The applicant or, if the applicant is a corporation, a corporate officer or the owner of the business has been convicted of, pled guilty or nolo contendere to, or has, in a judicial proceeding, admitted facts sufficient to find that he or she is guilty of a crime relating to the procuring, possessing, processing, storage, distribution, or sale of food in connection with the business;

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

(i) A business owned or operated by the applicant is, or was, the subject of a proceeding(s) which is still ongoing or resulted in the suspension, denial, or revocation of a license or permit, or refusal to renew the same;

(j) Failure to comply with all Massachusetts laws relating to taxes, reporting of employees and contractors, and withholding and remitting of child support as required by M.G.L. c. 62C, § 49A;

(k) Failure to pay administrative penalties or fines assessed by the regulatory agency in a timely manner; or

(l) Failure to comply with local regulations, bylaws, or ordinances related to the operation of the business.

(2) Notice of Refusal to Issue a License or Permit.
(a) The notice shall be in writing and shall specify the specific reasons(s) for which the license or permit is being denied, the applicable provisions of law, and the procedures for requesting any hearing to which the applicant may be entitled.

(b) The notice shall be served on the applicant using the same procedures specified in 105 CMR 500.206(B) for service of an Order to Cease and Desist.

(3) Hearing. To obtain a hearing, the applicant shall follow the procedures set forth in 105 CMR 500.208(B).

(B) Summary Suspension without a Prior Hearing.

(1) The regulatory agency may, without a prior hearing, suspend a license, permit, or certification, or one or more particular operations in a facility, if it finds that the licensee or permit holder is operating the facility in a manner which is endangering or may cause imminent danger to the public health.

(2) A summary suspension order shall be in writing and shall be immediately provided to the licensee, permit holder, or person in charge of the facility, and a copy shall be posted at the facility. The order shall state:
(a) The reason(s) for the summary suspension;

(b) The violation(s) leading to the determination that the facility is operating in a manner which is endangering or may cause imminent danger to the public health, and the applicable provisions of law;

(c) That all operations or one or more operations of the facility shall immediately cease and desist; and

(d) That an opportunity for a hearing shall be afforded if timely requested.

(3) The order of summary suspension shall be effective upon posting of the order at the facility by an authorized agent of the regulatory agency. If the person whose name appears on the license or permit is not present at the time of such posting, or if the licensee or permit holder is a corporation or other firm, a copy of the order of summary suspension shall also be served using the same procedures specified in 105 CMR 500.206(B) for service of an Order to Cease and Desist.

(4) The regulatory agency may end the summary suspension at any time if reasons for the suspension no longer exist.

(5) The inspection report and the Notice of Violations/Order to Correct shall constitute prima facie evidence of the conditions listed therein.

(C) Suspension, Revocation, or Refusal to Renew a License, Permit, or Certification, and/or Imposition of Administrative Penalties, after Opportunity for a Hearing.

(1) Suspension.
(a) After providing an opportunity for a hearing, the regulatory agency may suspend a license, permit, or certification, or one or more particular operations or activities of the facility, if the facility or the operation/activity does not comply with any one or more of the requirements of 105 CMR 500.000. Each day during which each noncompliance occurs or continues shall constitute a separate violation.

(b) The suspension shall continue until the regulatory agency determines that the required corrections have been made.

(2) Revocation. After providing an opportunity for a hearing, the regulatory agency may revoke a license, permit, or certification, or terminate one or more particular operations of the facility, if any one or more of the following grounds exists. Each of the following grounds shall constitute full and adequate grounds for such revocation.
(a) A serious violation or repeated violations of any of the requirements of 105 CMR 500.000 or of any relevant statute. Each day during which each violation occurs or continues shall constitute a separate violation;

(b) Interference with the regulatory agency or any of its authorized agents in the performance of its duties including, but not limited to, refusal to provide access to inspect any part of the premises;

(c) The licensee or permit holder, or if the licensee or permit holder is a corporation, a corporate officer or the owner of the facility has been convicted of, pled guilty or nolo contendere to, or has, in a judicial proceeding, admitted facts sufficient to find that he or she is guilty of a crime relating to the procuring, possessing, processing, storage, distribution, or sale of food in connection with the business;

(d) Keeping or submitting any misleading or false records or documents required by 105 CMR 500.000 or related law, or failing to keep records required to be kept;

(e) Failure to pay administrative penalties or fines assessed by the regulatory agency in a timely manner;

(f) Failure to immediately report to the regulatory agency:
1. When an imminent danger to the public health is present in the facility;

2. An outbreak of illness within the facility that may affect the safety of the food product; or

3. An outbreak of illness that may have been caused by a food product from the facility; or

(g) Failure to provide regulatory agency access to any and all records required to be kept by the licensee or permit holder.

(3) Refusal to Renew. The regulatory agency may refuse to renew a license, permit, or certification if the facility does not comply with any one or more of the following grounds. Each of the following grounds shall constitute full and adequate grounds for such refusal to renew.
(a) Any of the grounds specified in 105 CMR 500.207(A);

(b) Any of the grounds specified in 105 CMR 500.207(B); or,

(c) Any of the grounds specified in 105 CMR 500.207(C)(1) or (2).

(D) Administrative Penalties. The Department may assess administrative penalties, pursuant to M.G.L. c. 94, §305C, in lieu of, or in addition to, suspending, revoking, refusing to issue, or refusing to renew a license, or other enforcement procedures.

(1) Administrative penalties may be imposed against any person for one or more of the following grounds:
(a) Failure to correct a violation or deficiency that constitutes a critical violation in a timely manner. Penalties shall accrue from the date set for correction in the Notice of Violations/Order to Correct, until the violation or deficiency is corrected;

(b) The occurrence of a second critical violation for the same deficiency within any 12-month period. Penalties shall accrue from the date set for correction in the Notice of Violations/Order to Correct for the second critical violation or deficiency, until the violation or deficiency is corrected;

(c) Denial of entry to agents of the Department or any attempt to impede the work of a duly authorized agent or representative of the Department, including impeding the taking of photographs. Penalties shall accrue from the date of the denial of entry or other impediment, for each day until agents of the Department are granted unimpeded access;

(d) Failure to comply with an Order to Cease and Desist from the Department. Penalties shall accrue from the date of the issuance of the Order to Cease and Desist, until there is full compliance with the order;

(e) False certification of correction pursuant to 105 CMR 500.205(A);

(f) The operation of a facility without a license, for which penalties shall accrue for every day of operation without a license; or

(g) Failure to comply with any other requirement of 105 CMR 500.000.

(2) Determining the Monetary Amount of an Administrative Penalty.
(a) Maximum Penalty. The maximum administrative penalty for a single violation of any rule or regulation shall not exceed the amount specified in M.G.L. c. 94, § 305C.

(b) Level of Administrative Penalty.
1. The penalty shall be $500.00 for each day that a person fails to comply with an order to correct a critical violation.

2. The penalty shall be $100.00 for each day that a person fails to comply with an order to correct a non-critical violation.

3. The penalty for a false certification of correction shall be $200.00 for each violation falsely certified.

4. The penalty for the denial of entry to or impeding the work of a duly authorized agent or representative of the Department shall be $500.00 for each time entry is denied or work is impeded.

5. The penalty shall be $500.00 for each day that a person fails to comply with an Order to Cease and Desist from the Department.

6. The penalty shall be $500.00 for each day that a person operates a facility without a license.

(c) Repeated Noncompliance. Each day during which each noncompliance occurs or continues shall constitute a separate violation/offense and shall be subject to a separate penalty, not to exceed $500.00 per day, per violation. If noncompliance continues for any part of a day, that day shall be included in the calculation.

(d) Calculating the Duration of Continued and/or Repeated Noncompliance. Noncompliance shall be calculated commencing from the dates described in 105 CMR 500.207(D)(1). Penalties shall be assessed for each day of noncompliance, commencing on the date described in 105 CMR 500.207(D)(1) and continuing until the day when the person comes into compliance, or as established by the final agency decision. However, nothing in 105 CMR 500.207(D)(2)(d) prevents the person from accruing further penalties regarding the same violations commencing on the day following the date established by the final agency decision, which would form the basis of a future enforcement action.

(E) Surrender of License and Voluntary Closures.

(1) The licensee or permit holder must surrender the license or permit to the regulatory agency if there is a transfer of ownership, or if there is a cessation of operations at the facility for other than routine vacation or maintenance closures.

(2) The licensee or permit holder may voluntarily surrender the license or permit to the regulatory agency for any lawful reason.

Disclaimer: These regulations may not be the most recent version. Massachusetts may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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