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Public Health Service Food and Drug Administration 1997 Food Code |
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Annex 1 Enforcement |
1. PURPOSE
2. EXPLANATION
3. PRINCIPLE
4. RECOMMENDATION
5. PARTS
8-6 CONSTITUTIONAL PROTECTION
8-7 NOTICES
8-8 REMEDIES
1. PURPOSE
The purpose of this Annex is to set forth provisions, in codified form, that provide a full array of enforcement mechanisms while recognizing the diverse statutes and regulations that currently govern the operations of the thousands of state and local regulatory agencies.
2. EXPLANATION
State or local statutes, regulations, and ordinances vary in their design, specificity, and degree of comprehensiveness in that they may:
(A) Contain authorities that provide the basis for certain post-inspection compliance strategies but remain silent with respect to other enforcement mechanisms;
(B) Include specific requirements that are different from those provided in this Annex;
and
(C) Be structured so that provisions such as administrative procedures are embodied
in sections of the law that transcend and are separate from those governing food
establishments.
Consequently, in this document a deliberate attempt is made to extract those provisions
that could conceptually be adopted as an extension of Chapter 8 if they were compatible with
existing, governing state and local statutes. The extracted provisions are numbered to
sequentially follow Chapter 8 but are placed in this Annex so that regulatory agencies can
revise them to be consistent with their statutes and their needs as discussed in the
Recommendation, below.
It is anticipated that adoption of this Code will be facilitated by the fact that:
(A) The compliance provisions of Chapter 8 that should be an integral part of state or local food regulations are part of the text of the Code; and
(B) The administrative and judicial enforcement provisions that are critical to the framework of a food regulatory program, but that may be repetitive or discrepant when compared to state or local statutes, are separated in this Annex.
3. PRINCIPLE
Although the situations necessitating escalated enforcement actions comprise a small percentage of those encountered by the regulator, a full spectrum of enforcement tools must be available where immediate hazards exist, or where compliance is not obtained voluntarily. Thus, a jurisdiction must have in place both the necessary statutory framework that includes a broad-based, well-defined enforcement component and regulations that specify the requirements within those legal authorities. It is imperative that there be clearly stated and legally sound rules that include the criteria for compliance and enforcement, the responsibilities of all parties, sanctions for noncompliance, and due process guarantees.
4. RECOMMENDATION
FDA recommends that agencies assess their statutory provisions that pertain to food establishments in light of this Annex and consider proposing changes to their statutes and regulations where they determine that provisions contained within this Annex will strengthen their programs. Such an assessment may involve reviewing problems encountered in attempts to prosecute under existing state or local provisions; considering comments received by the regulatory authority about its enforcement process; consulting with staff and legal counsel to identify gaps or weaknesses in the provisions; comparing provisions with sister agencies for comprehensiveness, equity, and uniformity; and seeking input from outside sources that have experience in taking, or being the subject of, enforcement actions.
Appropriate wording and cross referencing changes to the provisions in this Annex may be necessary, based on whether they are adopted as statutes or regulations. Modifications to the adoption forms (Forms #4 and #5) may also be necessary based on that decision.
Parts
8-6 CONSTITUTIONAL PROTECTION
8-7 NOTICES
8-8 REMEDIES
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The regulatory authority shall justly apply the remedies according to law and this Code, to preserve the rights to equal protection and due process of a person to whom the remedies are applied.
A recipient of a regulatory authority order or decision may file a petition for judicial review in a court of competent jurisdiction after available administrative appeal remedies are exhausted.
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(Note: Adoption of this section provides the basis for serving notice of inspectional findings as specified in § 8-403.30 and would be cited there.)
A notice issued in accordance with this Code shall be considered to be properly served if it is served by one of the following methods:
(A) The notice is personally served by the regulatory
authority, a law enforcement officer, or a person authorized
to serve a civil process to the permit holder, the person in
charge, or person operating a food establishment without a
permit;
(B) The notice is sent by the regulatory authority to the last known address of the permit holder or the person operating a food establishment without a permit, by registered or certified mail or by other public means so that a written acknowledgment of receipt may be acquired; or
(C) The notice is provided by the regulatory authority in accordance with another manner of service authorized in law.
An employee restriction or exclusion order, an order to hold and not distribute food, such as a hold, detention, embargo, or seizure order which is hereinafter referred to as a hold order, or a summary suspension order shall be:
(A) Served as specified in ¶ 8-701.10(A); or
(B) Clearly posted by the regulatory authority at a public entrance to the food establishment and a copy of the notice sent by first class mail to the permit holder or to the owner or custodian of the food, as appropriate.
Service is effective at the time of the notice's receipt or if service is made as specified in ¶ 8-701.20(B), at the time of the notice's posting.
Proof of proper service may be made by affidavit of the person making service or by admission of the receipt signed by the permit holder, the person operating a food establishment without a permit to operate, or an authorized agent.
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The regulatory authority may seek an administrative or judicial remedy to achieve compliance with the provisions of this Code if a person operating a food establishment or employee:
(A) Fails to have a valid permit to operate a food establishment as specified under § 8-301.11;
(B) Violates any term or condition of a permit as specified under § 8-304.11;
(C) Allows serious or repeated code violations to remain uncorrected beyond time frames for correction approved, directed, or ordered by the regulatory authority under ¶¶ 8-405.11(A) and (B), and ¶¶ 8-406.11(A) and (B);
(D) Fails to comply with a regulatory authority order issued as specified in § 8-501.20 concerning an employee suspected of having a disease transmissible through food by infected persons;
(E) Fails to comply with a hold order as specified in §§ 8-701.20 and 8-803.10;
(F) Fails to comply with an order issued as a result of a hearing for an administrative remedy as specified in §§ 8-806.30 or 8-806.40; or
(G) Fails to comply with a summary suspension order issued by the regulatory authority as specified in §§ 8-701.20 and 8-804.10.
(Note: Adoption of this section provides the basis for Subparagraph 8-402.20(A)(3) and § 8-402.40 and would be cited there.)
The regulatory authority may order access for one or more of the following purposes, subject to law for gaining access:
(A) If admission to the premises of a food establishment is denied or other circumstances exist that would justify an inspection order under law, to make an inspection including taking photographs;
(B) To examine and sample the food; and
(C) To examine the records on the premises relating to food purchased, received, or used by the food establishment.
The regulatory authority's inspection order shall:
(A) Stipulate that access be allowed on or to the described premises, food, or records under the order's provisions;
(B) Provide a description that specifies the premises, food, or records subject to the order; and
(C) Specify areas to be accessed and activities to be performed.
(Note: Adoption of this section provides the basis for ¶¶ 3-202.18(B) and would be cited there.)
(A) According to time limits imposed by law, the regulatory authority may place a hold order on a food that:
(1) Originated from an unapproved source;
(2) May be unsafe, adulterated, or not honestly presented;
(3) Is not labeled according to law, or, if raw molluscan shellfish, is not tagged or labeled according to law; or
(4) Is otherwise not in compliance with this Code.
(B) If the regulatory authority has reasonable cause to believe that the hold order will be violated, or finds that the order is violated, the regulatory authority may remove the food that is subject to the order to a place of safekeeping.
The regulatory authority may issue a hold order to a permit holder or to a person who owns or controls the food, as specified in § 8-701.20, without prior warning, notice of a hearing, or a hearing on the hold order.
The hold order notice shall:
(A) State that food subject to the order may not be used, sold, moved from the food establishment, or destroyed without a written release of the order from the regulatory authority;
(B) State the specific reasons for placing the food under the hold order with reference to the applicable provisions of this Code and the hazard or adverse effect created by the observed condition;
(C) Completely identify the food subject to the hold order by the common name, the label information, a container description, the quantity, regulatory authority's tag or identification information, and location;
(D) State that the permit holder has the right to an appeal hearing and may request a hearing by submitting a timely request as specified in §§ 8-805.10 and 8-805.20;
(E) State that the regulatory authority may order the destruction of the food if a timely request for an appeal hearing is not received; and
(F) Provide the name and address of the regulatory authority representative to whom a request for an appeal hearing may be made.
(A) The regulatory authority shall securely place an official tag or label on the food or containers or otherwise conspicuously identify food subject to the hold order.
(B) The tag or other method used to identify a food that is the subject of a hold order shall include a summary of the provisions specified in § 8-803.10 and shall be signed and dated by the regulatory authority.
(A) Except as specified in ¶ (B) of this section, a food placed under a hold order may not be used, sold, served, or moved from the establishment by any person.
(B) The regulatory authority may allow the permit holder the opportunity to store the food in an area of the food establishment if the food is protected from subsequent deterioration and the storage does not restrict operations of the establishment.
The regulatory authority may examine, sample, and test food in order to determine its compliance with this Code.
Only the regulatory authority may remove hold order tags, labels, or other identification from food subject to a hold order.
If a hold order is sustained upon appeal or if a timely request for an appeal hearing is not filed, the regulatory authority may order the permit holder or other person who owns or has custody of the food to bring the food into compliance with this Code or to destroy or denature the food under the regulatory authority's supervision.
The regulatory authority shall issue a notice of release from a hold order and shall remove hold tags, labels, or other identification from the food if the hold order is vacated.
The regulatory authority may summarily suspend a permit to operate a food establishment if it determines through inspection, or examination of employees, food, records, or other means as specified in this Code, that an imminent health hazard exists.
The regulatory authority may summarily suspend a person's permit as specified in § 8-804.10 by providing written notice as specified in § 8-701.20 of the summary suspension to the permit holder or person in charge, without prior warning, notice of a hearing, or a hearing.
A summary suspension notice shall state:
(A) That the food establishment permit is immediately suspended and that all food operations shall immediately cease;
(B) The reasons for summary suspension with reference to the provisions of this Code that are in violation;
(C) The name and address of the regulatory authority representative to whom a written request for reinspection may be made and who may certify that reasons for the suspension are eliminated; and
(D) That the permit holder may request an appeal hearing by submitting a timely request as specified in §§ 8-805.10 and 8-805.20.
After receiving a written request from the permit holder stating that the conditions cited in the summary suspension order no longer exist, the regulatory authority shall conduct a reinspection of the food establishment for which the permit was summarily suspended within 2 business days, which means 2 days during which the regulatory authority's office is open to the public.
(A) A summary suspension shall remain in effect until the conditions cited in the notice of suspension no longer exist and their elimination has been confirmed by the regulatory authority through reinspection and other means as appropriate.
(B) The suspended permit shall be reinstated immediately if the regulatory authority determines that the public health hazard or nuisance no longer exists. A notice of reinstatement shall be provided to the permit holder or person in charge.
(Note: Adoption of this section provides the basis for ¶¶ 8-303.30(C) and 8-501.30(C). ¶¶ 8-805.10(C) and (D) would be cited there.)
(A) A person who receives a notice of hearing for an administrative remedy as specified in Part 8-7, § 8-801.10, or ¶ 8-805.30(A) and elects to respond to the notice shall file a response to notice as specified in § 8-805.20 within 7 calendar days after service.
(B) A permit applicant may request a hearing regarding the disposition of an application for a new or revised permit if the regulatory authority does not issue or deny the permit within the time frame specified in law.
(C) A permit holder may request a hearing to address concerns about the regulatory authority's denial of application for a permit or request for a variance, or compliance actions, except that a hearing request does not stay the regulatory authority's restriction or exclusion of employees specified in §§ 8-501.10 - 8-501.40, a hold order specified in § 8-803.10, or the imposition of a summary suspension specified in § 8-804.10.
(D) A person desiring a hearing in response to a denial of an application for permit or an adverse administrative determination shall submit a hearing request to the regulatory authority within 10 calendar days of the date of the denial, inspection, or compliance action, unless the regulatory authority specifies in certain situations that the request shall be submitted within a shorter period of time.
A response to a hearing notice or a request for hearing as specified in § 8-805.10 shall be in written form and contain the following:
(A) If a response to notice of hearing,
(1) An admission or denial of each allegation of fact;
(2) A statement as to whether the respondent waives the right to a hearing; and may also contain
(3) A statement of defense, mitigation, or explanation concerning any allegation of fact; and
(4) A request to the regulatory authority for a settlement of the proceeding by consent agreement, if the regulatory authority will provide this opportunity.
(B) If a request for hearing,
(1) A statement of the issue of fact specified in ¶ 8-805.30(B) for which the hearing is requested; and
(2) A statement of defense, mitigation, denial, or explanation concerning each allegation of fact.
(C) If either a response to notice of hearing or a request for a hearing,
(1) A statement indicating whether the presence of witnesses for the regulatory authority is required; and
(2) The name and address of the respondent's or requester's legal counsel, if any.
The regulatory authority shall hold hearings according to law and the provisions of this Code:
(A) As determined necessary by law or the regulatory authority to accomplish the purpose and intent of this Code specified in § 8-101.10; and
(B) As requested by a permit applicant or a permit holder if:
(1) Requested as specified in § 8-805.10, and
(2) The request demonstrates that there is a genuine and material issue of fact that justifies that a hearing be held.
Hearings shall be conducted according to law, administrative procedures, and this Code.
(A) The regulatory authority shall afford a hearing:
(1) Except as provided in ¶ (B) of this section, within 5 business days after receiving a written request for an appeal hearing from:
(a) A person who is excluded by the regulatory authority from working in a food establishment as specified in §§ 8-501.10 - 8-501.40,
(b) A permit holder or person whose food is subject to a hold order as specified in Subpart 8-803, or
(c) A permit holder whose permit is summarily suspended as specified in Subpart 8-804; and
(2) Within 30 calendar days but no earlier than 7 calendar days after the service of a hearing notice to consider administrative
remedies for other matters as specified in ¶ 8-805.10(C) or for matters as determined necessary by the regulatory authority.
(B) A permit holder or person who submits a request for a hearing as specified in Subparagraphs (A)(1)(a)-(c) of this section may waive the prompt hearing in the written request to the regulatory authority.
A notice of hearing shall contain the following information:
(A) Time, date, and place of the hearing;
(B) Purpose of the hearing;
(C) Facts that constitute the basis or reason for the hearing including specific details of violations or allegations;
(D) The rights of the respondent, including the right to be represented by counsel and to present witnesses and evidence on the respondent's behalf as specified in § 8-807.10;
(E) At the regulatory authority's discretion, the procedure for the respondent to request an offer from the regulatory authority to settle the matter;
(F) The consequences of failing to appear at the hearing;
(G) The maximum sanctions or penalties as specified in ¶¶ 8-806.40(B)-(D) that may result from the hearing if the hearing concerns a proposed administrative remedy and if the facts are found to be as alleged;
(H) If the hearing concerns a proposed administrative remedy, a statement specifying the form and time frame for response as specified in § 8-805.10;
(I) Notification that the written response shall include the information specified in § 8-805.20; and
(J) The name and address of the person to whom such written response shall be addressed.
A hearing proceeding commences at the time the regulatory authority notifies the respondent of the hearing proceeding.
Hearings shall be conducted in an expeditious and impartial manner.
(A) Hearings or portions of hearings may be closed to the public:
(1) If compelling circumstances, such as the need to discuss in the hearing a person's medical condition or a food establishment's trade secrets, indicate that it would be prudent; and
(2) According to law, such as an open meetings law.
(B) A party to a hearing shall maintain confidentiality of discussions that warrant closing the hearing to the public.
A complete record of a hearing shall be prepared under the direction of the person conducting the hearing and maintained as part of the regulatory authority's records for the food establishment. Except as required by law, a verbatim transcript of the hearing need not be prepared.
The regulatory authority may appoint a person such as an adjudicator, administrative law judge, or examiner, hereinafter referred to as a hearing officer, who presides over a proceeding
initiated by the regulatory authority or by a person contesting an action of the regulatory authority, to perform one or more of the following:
(A) Hear the facts presented by an applicant or a permit holder;
(B) Make a decision or recommendation concerning administrative remedies to achieve compliance with this Code; or
(C) Address other concerns or allegations appropriately raised according to law, in the matter before the hearing officer.
A hearing officer shall be knowledgeable of the provisions of this chapter and the law as they relate to hearings, and be:
(A) A regulatory authority representative other than the person who inspects the food establishment or who has any other role in making the decision that is being contested; or
(B) An individual who is not employed by the regulatory authority.
(A) A hearing officer shall have the following powers in a hearing in which the hearing officer presides:
(1) Setting and conducting the course of a hearing requested in accordance with or authorized by this Code,
(2) Issuing subpoenas in the name of the regulatory authority at the request of a party to a hearing, administering oaths and affirmations, examining witnesses, receiving evidence,
(3) Approving a consent agreement on the issues involved in the hearing entered into by the regulatory authority and the respondent after the respondent receives a hearing notice,
(4) Sustaining, modifying, rescinding, or vacating an order or directive of the regulatory authority in an appeal hearing proceeding, and if the order or directive is sustained, ordering appropriate measures to execute the regulatory authority's order or directive; and
(B) Unless a party appeals to the head of the regulatory authority within 15 days of the hearing or a lesser number of days specified by the hearing officer:
(1) Rendering a binding decision and final order in a proceeding after conducting a hearing, if the respondent has not waived the right to a hearing, and
(2) Then notifying the respondent of the decision and the order which contains the findings and conclusions of law.
The hearing officer shall have the following powers in a hearing proceeding concerning an administrative remedy specified in §§ 8-801.10 and 8-805.30:
(A) Issuing orders to abate or correct violations of this Code and establishing a schedule for the abatement or correction of violations;
(B) Making a finding of fact regarding the occurrence of each violation and assessing, levying, and ordering a reasonable civil penalty, according to law and not to exceed the amount specified in ¶ 8-813.10(B) for each violation of this Code that is alleged and found to be committed, and calculated based on each day a violation occurs as specified in ¶ 8-813.10(C);
(C) Suspending, revoking, modifying, or imposing reasonable restrictions or conditions on a permit to operate a food establishment, or ordering the closure of a food establishment that is operated without a valid permit as required under § 8-301.11 of this Code;
(D) Making a finding of fact regarding the occurrence of each violation of the regulatory authority's or hearing officer's lawful order issued in accordance with this Code and assessing, levying, and ordering a reasonable civil penalty, in accordance with law and not to exceed the amount specified in ¶ 8-813.10(B) for each violation of this Code that is alleged and found to be committed, and calculated based on each day a violation occurs as specified in ¶ 8-813.10(C);
(E) Deferring or suspending the imposition of a decision or execution of an order, and imposing a probationary period, upon the condition that the respondent comply with the hearing officer's reasonable terms and conditions;
(F) Dismissing the appeal if the matter is settled between the regulatory authority and the respondent after a hearing notice is served;
(G) Ordering reinspection of a food establishment to determine compliance with a hearing officer's order;
(H) Suspending or ordering the payment of a fee established by the regulatory authority for a reinspection that is required to determine compliance and for the reinstatement of a permit after suspension;
(I) Retaining and exercising jurisdiction for a specific period of time not to exceed 90 calendar days after the hearing officer's decision and final order is issued, over a respondent who receives a hearing notice; and
(J) Modifying or setting aside an order by rehearing upon the hearing officer's own motion, the motion of the regulatory authority, or the motion of the respondent.
Parties to a hearing may be represented by counsel, examine and cross examine witnesses, and present evidence in support of their position.
The regulatory authority shall present at the hearing its evidence, orders, directives, and reports related to the proposed or appealed administrative remedy.
Evidence shall be excluded:
(A) If it is irrelevant, immaterial, unduly repetitious, or excludable on constitutional or statutory grounds or on the basis of evidentiary privilege recognized by the state's courts; or
(B) Otherwise according to law.
Testimony of parties and witnesses shall be made under oath or affirmation administered by a duly authorized official.
Written evidence may be received if it will expedite the hearing without substantial prejudice to a party's interests.
Documentary evidence may be received in the form of a copy or excerpt.
The regulatory authority may settle a case after a notice of hearing is served by providing a respondent with an opportunity to request a settlement before a hearing commences on the matter and by entering into a consent agreement with the respondent.
Respondents accepting a consent agreement waive their right to a hearing on the matter.
(Note: Adoption of this section provides the basis for Subparagraph 8-402.20(A)(3) and § 8-402.40 and would be cited there.)
The regulatory authority may seek access for one or more of the following purposes, according to law for gaining access:
(A) If admission to the premises of a food establishment is denied or other circumstances exist that would justify an inspection order under law, to make an inspection including taking photographs;
(B) To examine and sample the food; and
(C) To examine the records on the premises relating to food purchased, received, or used by the food establishment.
In the absence of a specific set of requirements established by law, in its petition to the court to compel access the regulatory authority shall:
(A) Describe in detail the premises, food, or records on or to which access was denied;
(B) Detail the legal authority to regulate and to have access for a specific purpose on or to the premises, food, or records where access was denied; and
(C) Provide information that the food establishment possesses a valid permit from the regulatory authority and that it applies to the premises where access was denied; or
(D) Provide information that a person is known to be or suspected of operating a food establishment without possessing a valid permit as specified in law and under this Code.
The regulatory authority shall demonstrate to the court by affidavit, sworn testimony, or both that:
(A) Access on or to the premises, food, or records was denied after the regulatory authority acted as specified in §§ 8-402.20 and 8-402.30; or
(B) There is reason to believe that a food establishment is being operated on the premises and that access was denied or is sought under a regulatory authority's reasonable administrative plan to enforce the provisions of this Code.
Upon petition of the regulatory authority, the court may issue an inspection order that:
(A) Includes the information specified in ¶¶ 8-802.20(A)-(C); and
(B) Orders or authorizes any other identified agencies and persons including law enforcement agencies to execute, or assist with the execution of, the order.
Upon petition of the regulatory authority, the court may further issue an inspection order that:
(A) Provides a maximum time limit for the order's execution;
(B) Authorizes law enforcement officers who assist in the order's execution to use necessary force against persons or property to execute the order; and
(C) Requires that the agencies or persons ordered or authorized to execute the order shall report to the court the date and time of the order's execution and the findings reached by the inspection, examination, or sampling conducted under the order.
(A) Proceedings to enforce this Code may be instituted by the regulatory authority according to law by issuing a citation or summons, by filing a misdemeanor complaint affidavit and request for a warrant of arrest with the court of competent jurisdiction, or by referring the complaint to a grand jury for indictment, as appropriate.
(B) The regulatory authority may designate a representative to issue summons or citations or sign warrants on behalf of the agency.
(A) The regulatory authority may seek to enforce the provisions of this Code and its orders by instituting criminal proceedings as provided in law against the permit holder or other persons who violate its provisions.
(B) A person who violates a provision of this Code shall be guilty of a misdemeanor, punishable by:
(1) A fine of not more than (designate amount) dollars, or by imprisonment not exceeding 1 year, or both the fine and imprisonment; or
(2) If the person has been convicted once of violating this Code or if there is an intent to defraud or mislead, a fine not exceeding (designate amount) or imprisonment not exceeding (designate time) year(s) or both.
(C) Each day on which a violation occurs is a separate violation under this section.
The regulatory authority may, according to law, petition a court of competent jurisdiction for temporary or permanent injunctive relief to achieve compliance with the provisions of this Code or its orders.
(A) The regulatory authority may petition a court of competent jurisdiction to enforce the provisions of this Code or its administrative orders and according to law collect penalties and fees for violations.
(B) In addition to any criminal fines and sentences imposed as specified in § 8-811.10, or to being enjoined as specified in § 8-812.10, a person who violates a provision of this Code, any rule or regulation adopted in accordance with law related to food establishments within the scope of this Code, or to any term, condition, or limitation of a permit issued as specified in §§ 8-303.10 and 8-303.20 is subject to a civil penalty not exceeding (designate amount).
(C) Each day on which a violation occurs is a separate violation under this section.