Enforcement Policy Introduction While it is expected that all firms will be voluntarily compliant with state regulations through the division’s compliance assistance approach, enforcement by the agency is required in many instances. At such times, a progressive enforcement approach is utilized by the division. This approach begins with providing education/information and progresses to a penalty or restriction of a firm’s operations. When applied consistently to all firms, it promotes fair and objective treatment. It is also critical to note that persons regulated under state law have a constitutional right to equal protection and due process. Due process required under the Administrative Procedures Act is incorporated into this policy. Key to any enforcement program is the need for timely and appropriate follow-up. Any order or enforcement decision must include follow-up by inspector or supervisor to ensure the enforcement action results in 1) firm compliance; or 2) further enforcement This policy is meant to provide flexibility. It does not dictate what specific action must occur, but provides choices for each level of enforcement. The decisions regarding particular actions will be made by regional and Lansing management given the specifics of each case. In general, the steps leading to an enforcement action are: A. Evaluations (Inspections) B. Documenting violations C. Assessing history with respect to violations and enforcement D. Flagging establishment for enforcement review by supervisor E. Determining status F. Deciding appropriate enforcement action G. Implementing enforcement action The Michigan Food Law, §289.5105(3) states: “This section does not require the department to issue an administrative fine for minor violations of this act whenever the department believes that the public interest will be adequately served under the circumstances by a suitable written notice or warning.” A. Inspection There are two types of evaluations (inspections) used in evaluating a firm for compliance, as follows: Routine inspection is a full evaluation (inspection) that occurs at a specified time interval. It is expected that all areas of firm are evaluated during this evaluation (inspection) and all significant violations documented. In addition to notification of violations, the routine evaluation (inspection) provides the opportunity for education to correct violations and achieve compliance. The interval for routine inspection is dependent on the risk category of the establishment. Change in the risk category is the only factor that may change the routine inspection frequency. Follow-up inspection (re-inspection) is a partial inspection that focuses only on those violations previously documented and scheduled for follow-up. Follow-up inspections are generated by (1) the presence of an uncorrected priority foundation and foundation violation, (2) the result of an enforcement Confidential Page 1 1/25/2015 action, or (3) requested by the licensee. Key to an effective enforcement policy, follow-up inspections verify whether violation corrections were completed or if there is a need for further enforcement action. Follow-up inspections (re-inspections) are not intended to be lengthy visits. The inspector should not inspect the entire firm at this time, but concentrate on violations previously cited. However, if a new serious violation is present, the inspector should document it and complete appropriate follow-up. B. Documenting violations At a minimum, each firm is evaluated with respect to state regulations at routine inspection intervals. Assessment is based on presence of violations at the time of inspection, as well as history of violations and/or enforcement. Inspection reports should convey violations clearly and concisely. Further, firm should be informed of compliance expectations through discussion and/or providing copies of laws and regulations. It is expected that all violations are corrected in a timely manner; otherwise enforcement action may be required. Violations are categorized with regard to severity or type. They are classified as follows: Priority and Priority Foundation (P and PF) violations are those that document conditions the Centers for Disease Control and Prevention (CDC) has found to be highly associated with foodborne illness. Critical violations must be corrected immediately; a follow-up inspection will occur within 0-10 days to document corrections. Core (C) violations are those that document conditions that are in violation of the law, but are not classed as P or Pf violations. At a minimum, C violations are re-assessed at each routine inspection. They shall be re-assessed more frequently if they migrate to a P or Pf violation or if enforcement action dictates. Core violations can evolve into P or Pf violations, core violations that have a potential for impacting food safety must be corrected by the 31st day after the initial citation. When such a core violation is identified a reinspection must be conducted to ensure that these violations have been corrected and do not become food safety issues. Substantial hazard is an overall condition at a food establishment that the director determines requires immediate action to prevent endangering the health of people. C. Assessing history Firm history with regard to violations, is evaluated and classified as follows: Continuous violation is a specific violation that is observed during a routine inspection, is documented, and persists on more than one inspection without correction. Recurring violation is a specific violation that is observed during a routine inspection, is documented, is corrected, and recurs. Confidential Page 2 1/25/2015 D. Notifying supervisor of establishments requiring enforcement review Establishments will be brought to the attention of the supervisor when conditions warrant an enforcement review. The supervisor will be notified of the violation history and enforcement history of the firm and will be expected to make a decision on further enforcement or other method of achieving compliance. The violations will be tracked by the inspector who will notify supervisor of need for enforcement review in the following conditions: Continuous P or Pf violation – the same P or Pf violation is documented and is uncorrected at two (2) consecutive inspections (routine inspection plus follow-up inspection) Recurring P or Pf violation – the same P or Pf violation is documented at three (3) consecutive routine inspections, but is corrected after each documentation Continuous C violation – the same C violation is documented and is uncorrected at three (3) consecutive inspections Recurring C violation – the same C violation is documented at four (4) consecutive routine inspections, but is corrected after each documentation When notified of establishments in need of enforcement review, the supervisor has the option of choosing an enforcement action, a follow-up inspection, or no action, depending on the factors involved. For each enforcement activity, a follow-up inspection shall occur within a maximum of 30 days. Excess fat means the percentage the fat content exceeds the applicable standard. For example: 33% fat in hamburger and 22% fat in ground beef represent 10% excess fat (10% more than the standard). Added moisture for sausage products shall not exceed 4 times the percentage of protein with an additional 3% water to facilitate chopping or mixing, based upon the applicable standard of identity for the sausage. For example a 15% protein sausage shall not contain more than 60% water: 65% water would represent 2% excess moisture. For ground meats, the moisture content shall not exceed the normal percentage of moisture normally found in the meat. Once an establishment begins the enforcement review process, the establishment will continue to be monitored at each visit until violations are corrected. E. Determining status Firm status will be assessed at each visit. The status will fall into one of the following categories: Non-actionable – no uncorrected P or Pf violations exist, C violations may exist but are not at a level requiring enforcement review Pending – firm is awaiting follow-up inspection as the result of violations Actionable – firm is flagged for enforcement; an enforcement action has been initiated Confidential Page 3 1/25/2015 Fail – firm has entered the license revocation process (includes informal hearing stage) F. Enforcement Actions The goal of this policy is to have consistent and progressive enforcement when enforcement is warranted. The actions are defined below in order by increasing severity. Administrative fine – See Attachment 1 for procedure Compliance review – meeting between a licensee or designated representative, and division representatives. The purpose of the meeting is to clarify expectations for food protection and sanitation, and the consequences of failure to maintain department standards. The meeting also offers an opportunity for the firm to demonstrate their plan for addressing food safety issues. The meeting may result in an agreement for compliance. Follow-up inspection is required to verify corrections and compliance. Notification to firm regarding a compliance review should include the following: Notice stating reasons for the meeting: List of deficiencies or statement of involved issues Legal authority Time, date, and place of meeting Notification to firm after compliance review should include the following: Results of the meeting Those in attendance at the meeting Purpose and authority for meeting Items discussed Items resolved New compliance dates or agreement reached Signatures of firm representative and division representatives Manager food safety training (decided at a compliance review) – department director, or designee, may require certain individuals to complete manager food safety training if there is a repeated failure to correct a critical violation. Warning letter – letter issued by supervisor that explains violations and establishes new compliance dates for correction of violations; follow-up inspection required to verify correction of violations. Prosecution (misdemeanor) – division representatives file complaint with county prosecutor for violation of state laws or regulations. Prosecution (felony) – division representative files a complaint with the county prosecutor requesting felony charges based on claim that defendant knowingly violated sections 5101(1)(b) or 5101(1)(l). Informal hearing – a meeting between a licensee or designated representative, and division representatives with an impartial MDARD hearings officer. This is preliminary to issuance of a formal Confidential Page 4 1/25/2015 notice of the department’s intent to revoke or suspend the license. This process must be coordinated through the Lansing office with concurrence by the executive office. License limitation – limitation made by the department director, or designee. Limitation may be imposed based upon either inadequate facilities or improper food handing. Licensee is provided an opportunity for an administrative hearing on the issue of the imposition of the license limitation. Licensee may, at any time, request a re-inspection of the food establishment for removing the limitation and reinstating the full license. License revocation or suspension – process that begins with the informal hearing and offers the opportunity for a formal (contested case) hearing. The hearing is attended by licensee, division representatives, and department hearing officer. This process must be coordinated through the Lansing office with concurrence by the executive office. Cease food operation order – order made by the department director, or designee, for immediate cessation of operation of a food establishment based upon a determination that continued operation would create an imminent or substantial hazard to the public health. Licensee may request an administrative hearing. Re-inspection must occur in order to resume operations. Summary suspension of license – department director may summarily suspend a license or registration, based on evidence that an imminent threat to the public health, safety, or welfare exists. Licensee may petition the director to dissolve the order. The director shall schedule a hearing to decide whether to grant or deny the petition to dissolve the order. Additional Tools: These tools may be used in conjunction with enforcement action, but not in place of enforcement action. These tools are not considered enforcement actions in and of themselves. However, they may be useful in achieving compliance when used in combination with an enforcement action. Seizure – order issued to hold food found to be sold, held for sale, or exposed for sale in violation of state laws and regulations, or suspected of being in violation of state laws and regulations. Follow-up is required to record disposition of product. $60 Second re-inspection fee – assessed at the second re-inspection for an uncorrected critical violation. Injunction – department may apply to circuit court to grant a temporary or permanent injunction restraining any person from violating specified provisions of the state laws and regulations. G. Implementing Enforcement Action Progressive enforcement begins with first evaluating the trigger event (e.g., substantial hazard, repeated P or Pf violations, etc.) and then deciding on the appropriate enforcement action. If the initial enforcement action is ineffective in gaining compliance, a more severe enforcement action is warranted. The following table (Table A) provides the usual sequence of enforcement actions for a given trigger event. Confidential Page 5 1/25/2015 Table A Progressive Enforcement Action Chart The following table identifies a trigger event and gives the corresponding steps in progressive enforcement. The steps of enforcement are necessary in cases where compliance is not achieved with an initial enforcement action. Departures from the enforcement progression may occur as deemed appropriate by supervisor and Lansing management. Additional tools such as seizure, insanitary notice, and $60 re-inspection fee may be used with any enforcement action. Trigger Event Substantial Hazard Egregious Violation of Prohibited Acts (MCLA §289.5101(1)) Supervisor notified immediately Comminuted Meat Violations Supervisor notified by Laboratory report Continuous Uncorrected P or Pf Violation Supervisor initially notified after violation remains uncorrected at two (2) consecutive inspections Confidential Steps in Progressive Enforcement 1) Cease food operation order 2) Summary suspension of license 1) Administrative Fine 2) Compliance Review in conjunction with 1st or 2nd Administrative Fine; may include required manager training 3) Prosecution 4) License revocation/limitation 1) Warning Letter ≤ 10% excess fat, ≥ 15% excess moisture, prohibited cereals and or binders and no regulatory action within the past two years. 2) 1st Administrative fine: size of fine; for fat content depends upon percentage of standard, or for excess moisture depends upon percentage above the standard, see table 1 3) 2nd Administrative fine: size of fine; for fat content depends upon percentage of standard, or for excess moisture percentage above the standard, see table 1 4) Compliance Review Meeting can be in conjunction with actions 1 or 2 listed above. 5) Prosecution 6) License revocation/limitation 1) 1st Administrative Fine – Food Code, CFR, Regulation/Rule violation or Prohibited Acts violation 2) Compliance Review – in conjunction with 1st or 2nd Administrative Fine; may include required manager training 3) 2nd Administrative Fine – Food Code violation or Prohibited Acts violation 4) Prosecution 5) License revocation/limitation Page 6 1/25/2015 Recurring P or Pf Violation 1) Compliance Review for Food Code, CFR, Regulation/Rule violation or Prohibited Acts violation and or 1st Administrative Fine. 2) 1st Administrative Fine – Prohibited Acts violation 3) 2nd Administrative Fine – Prohibited Acts violation 4) Prosecution 5) License revocation/limitation Continuous Uncorrected C Violation 1) Warning letter 2) 1st Administrative Fine – Food Code violation or General Violation of CFR, Regulation/Rule violation or Prohibited Acts violation 3) 2nd Administrative Fine – Food Code violation or General Violation of CFR, Regulation/Rule violation or Prohibited Acts violation 4) Prosecution if extensive 5) License revocation/limitation 1) Warning letter 2) 1st Administrative Fine – General Violation of law 3) 2nd Administrative Fine – General Violation of law 4) Prosecution if extensive 5) License revocation/limitation Supervisor initially notified after violation is documented at three (3) consecutive inspections; violation correction is also documented Supervisor initially notified after violation remains uncorrected at three (3) consecutive inspections Recurrent C Violation Supervisor initially notified after violation is documented at four (4) consecutive inspections; violation correction is also documented Attachment 1 - Administrative Fine Assessment Background Among the penalties provided in the Food Law of 2000, is the administrative fine (MCLA 289.5105). As described in the law, it may be levied when a person is found to have violated a provision of the act or rule promulgated under the act. With the first offense, the fine may not be more than $500.00. With the second or subsequent offense, the fine may not be more than $1000.00 and may include the cost of the investigation. The statute further states an annual cap on the aggregate amount of fines imposed that is dependent on the size of the operation. For those firms with annual gross receipts of $500,000.00 or less, the department shall not assess fines in excess of $4,000.00 per location per year. For those firms with annual gross receipts over $500,000.00, the department shall not assess fines in excess of $8,000.00 per location per year. Assessing an Administrative Fine The regional supervisor and inspector will work together to determine potential candidates for administrative fines. The supervisor then documents the relevant paperwork in the inspection system, The final decision regarding an administrative fine will be based on the following: Violation clearly stated on all inspection and reinspection reports so as to give licensee adequate notice of violation Violation clearly stated as violation of Food Law of 2000, Food Code, CFR’s, Rules or Regulations and correctly designated as P, Pf or C Correction schedule for violations clearly stated on inspection reports Confidential Page 7 1/25/2015 Correction schedule of at least 30 days for Food Code, CFR’s, Rules or Regulations C violations and general violations of the Food Law of 2000 [“general violations” refer to those violations of the Food Law of 2000, other than the Prohibited Acts, §289.5101(1)] In the documentation for an administrative fine, please include the following: 1) Demographics of the firm, name, address, license number 2) Narrative outlining firm’s history, including previous enforcement actions. 3) Citation of violation, description of violation, including references e.g.: Michigan Food Law (MFL), 289.5101(1), (d) or Food Code (FFC), 3-302.11 and dates of violation. 4) Documentation of previous violation history, e.g.: Copies of warning letters, copies of compliance review meeting letters, copies of previous inspections, copies of previous administrative fine letters and similar items that will support your request. 5) Your recommendation for an enforcement action to be taken. Determining Fine Amount The fine amount is calculated per violation and is stratified on the section of the act violated. Table 1 lists the fine amounts for Prohibited Acts [MCL 289.5101(1)] and general violations of the MFL, and the P, Pf or C violations of the Food Code, CFR’s, Rules and Regulations. Fines for Prohibited Acts may be assessed on the first occurrence if it is of immediate public health concern. Fines for Food Code P or Pf violations may be assessed if the violation remains uncorrected beyond the time frame for correction. Food Code C violations and general violations of the act shall allow for at least 30 calendar days for correction before assessing an administrative fine. This table also includes the costs for investigation that may be included for second or subsequent fines. The costs for investigation are based on inspector time (including travel time), travel miles, clerical support time, supervisor review time, and Lansing review time. Notification and Appeal of an Administrative Fine When an administrative fine is assessed, notification is sent certified mail from the Lansing office. The notification states the observed violation, the appropriate law citation, and the process for appeal. Table 1 Fine Structure – Prohibited Acts §289.5101(1) and other violation of the Michigan Food Law and its associated standards Level Level I Violation For example but not limited to: (k) Permit filthy or insanitary (a, b)Adulterated or misbranded food Confidential 1st Occurrence Amount of Fine $500 - Pathogens - Chemicals - Allergens - Major misbranding (e.g., sulfites not declared; Page 8 $500 $500 $500 $500 2nd Occurrence Amount of Fine $1000 + $80/hr cost $1000 + $80/hr cost 1/25/2015 (a, b) Adulterated food Level II smoked fish warning labels incomplete) -Prohibited substance in comminuted meat (e.g. by-products, extenders, etc.) Severe out of temperature $400 (f) Refuse to permit entry, inspection or taking sample (n) Interfere with inspector $500 (l) Falsely identify country or state of origin, Knowingly (h) Remove seized food, that was tagged, marked and isolated (j) Forge any mark, stamp, tag, label (l) Falsely identify country or state of origin, Inadvertently (a, b) Adulterated or misbranded food $500 (a, b) Adulterated or misbranded food (o) False statement on any report, plan… (m) Fail to maintain records $300 $500 $300 $300 - Infested (rodent defiled canned goods) - Excess fat in comminuted meat 30% or greater (as a percentage of the standard) -Excess moisture in comminuted meat 15% or greater (percentage above the standard) $300 - Outdated $200 $300 $300 (p) Remove tag or seal Level I $400 (a, b) Adulterated or misbranded food Confidential $300 - Minor misbranding (e.g., $200 incomplete ingredient declaration on standardized foods; failure to list the percentage juice) - Excess fat in Page 9 $800 + $80/hr cost $1000 + $80/hr cost $600 + $80/hr cost $1000 + $80/hr cost $1000 + $80/hr cost $600 + $80/hr cost $600 + $80/hr cost $600 + $80/hr cost $600 + $80/hr cost $400 + $80/hr cost $400 + $80/hr cost $400 + $80/hr cost $400 + $80/hr cost 1/25/2015 comminuted meat below 30% (percentage of standard) - Excess moisture in comminuted meat below 15% (percentage above the standard) Critical Noncritical (i) Remove or destroy labeling on food (e) Disseminate false advertising $200 (g) Give false guaranty $200 P or Pf violation of Food Code or Food Law (non prohibited act) Core violation of Food Code or Food Law NOTE: Confidential $200 Violation remains uncorrected beyond the time frame for correction Violation remains uncorrected beyond time frame for correction (time frame for correction must be at least 30 days) $400 + $80/hr cost $400 + $80/hr cost $400 + $80/hr cost $200 $400 + $80/hr cost $100 $200 + $80/hr cost 3rd occurrence fine would rarely be used; alternative enforcement would be utilized. 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