U. S. Department of Health and Human Services
Public Health Service
Food and Drug Administration
2001 Food Code
(Updated April 2004*)
Supplement to the 2001 Food Code


Annex
1

   Compliance and Enforcement

1. PURPOSE
2. EXPLANATION
3. PRINCIPLE
4. RECOMMENDATION
5. PARTS

    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:

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:

    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 #2-A and #2-B in Annex 7) may also be necessary based on that decision.


Parts
8-6   CONSTITUTIONAL PROTECTION
8-7   NOTICES
8-8   REMEDIES


8-6     CONSTITUTIONAL PROTECTION

Subparts
8-601     Procedural Safeguards
8-602     Judicial Review

Procedural Safeguards

   8-601.10   Preservation of Rights.

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.

Judicial Review

   8-602.10   Rights of Recipients of Orders or Decisions.

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.


8-7     NOTICES

Subpart
8-701   Service of Notice

Service of Notice

   8-701.10   Proper Methods.

(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:

   8-701.20   Restriction or Exclusion Order, Hold Order or Summary Suspension.

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:

   8-701.30   When Notice is Effective.

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.

   8-701.40   Proof of Proper Service.

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.


    8-8   REMEDIES

Subparts
  8-801   Criteria for Seeking Remedies
 
  Administrative
  8-802   Administrative Inspection Orders
  8-803   Holding, Examination, and Destruction of Food
  8-804   Summary Permit Suspension
  8-805   Hearings Administration
  8-806   Hearing Officer, Purpose, Qualifications, Appointment, and Powers
  8-807   Rights of Parties and Evidence
  8-808   Settlement
 
  Judicial
  8-809   Judicial Inspection Orders
  8-810   Means of Instituting Judicial Enforcement Proceedings
  8-812   Injunctive Proceedings
  8-813   Civil Proceedings

Criteria for Seeking Remedies

   8-801.10   Conditions Warranting Remedy.

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:

Administrative Inspection Orders

   8-802.10   Gaining Access to Premises and Records.

(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:

   8-802.20   Contents of Inspection Order.

The regulatory authority's inspection order shall:

Holding, Examination, and Destruction of Food

   8-803.10   Hold Order, Justifying Conditions and Removal of Food.

(Note: Adoption of this section provides the basis for ¶ 3-202.18(B) and would be cited there.)

   8-803.20   Hold Order, Warning or Hearing Not Required.

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.

   8-803.30   Hold Order, Contents.

The hold order notice shall:

   8-803.40   Hold Order, Official Tagging of Food.

   8-803.51   Hold Order, Food May Not Be Used or Moved.

   8-803.60   Examining, Sampling, and Testing Food.

The regulatory authority may examine, sample, and test food in order to determine its compliance with this Code.

   8-803.70   Hold Order, Removing the Official Tag.

Only the regulatory authority may remove hold order tags, labels, or other identification from food subject to a hold order.

   8-803.80   Destroying or Denaturing Food.

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.

   8-803.90   Releasing Food from Hold Order.

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.

Summary Permit Suspension

   8-804.10   Conditions Warranting Action.

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.

   8-804.20   Summary Suspension, Warning or Hearing Not Required.

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.

   8-804.30   Contents of the Notice.

A summary suspension notice shall state:

   8-804.40   Time Frame for Reinspection.

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.

   8-804.50   Term of Suspension, Reinstatement of Permit.

Hearings Administration

   8-805.10   Response to Notice of Hearing or Request for Hearing, Basis and Time Frame.

(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.)

   8-805.20   Response to a Notice of Hearing or Request for Hearing, Required Form and Contents.

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:

   8-805.30   Provided Upon Request.

The regulatory authority shall hold hearings according to law and the provisions of this Code:

   8-805.40   Provided in Accordance with Law.

Hearings shall be conducted according to law, administrative procedures, and this Code.

   8-805.50   Timeliness, Appeal Proceeding Within 5 Business Days, Other Proceeding Within 30 Calendar Days.

   8-805.60   Notice, Contents.

A notice of hearing shall contain the following information:

   8-805.70   Proceeding Commences Upon Notification.

A hearing proceeding commences at the time the regulatory authority notifies the respondent of the hearing proceeding.

   8-805.80   Procedure, Expeditious and Impartial.

Hearings shall be conducted in an expeditious and impartial manner.

   8-805.90   Confidential.

   8-805.100   Record of Proceeding.

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.

Hearing Officer, Purpose Qualifications, Appointment, and Powers

   8-806.10   Appointment by Regulatory Authority and Purpose.

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:

   8-806.20   Qualifications.

A hearing officer shall be knowledgeable of the provisions of this chapter and the law as they relate to hearings, and be:

   8-806.30   Powers, Administration of Hearings.

   8-806.40   Powers, Administrative Remedies.

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:

Rights of Parties and Evidence

   8-807.10   Rights of Parties.

Parties to a hearing may be represented by counsel, examine and cross examine witnesses, and present evidence in support of their position.

   8-807.20   Evidence to be Presented by the Regulatory Authority.

The regulatory authority shall present at the hearing its evidence, orders, directives, and reports related to the proposed or appealed administrative remedy.

   8-807.30   Evidence to be Excluded.

Evidence shall be excluded:

   8-807.40   Testimony under Oath.

Testimony of parties and witnesses shall be made under oath or affirmation administered by a duly authorized official.

   8-807.50   Written Evidence.

Written evidence may be received if it will expedite the hearing without substantial prejudice to a party's interests.

   8-807.60   Documentary Evidence.

Documentary evidence may be received in the form of a copy or excerpt.

Settlement

   8-808.10   Authorization.

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.

   8-808.20   Respondent Acceptance of Consent Agreement Is Waiver of Right to Appeal.

Respondents accepting a consent agreement waive their right to a hearing on the matter.

Judicial Inspection Orders

   8-809.10   Gaining Access to Premises and Records.

(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:

   8-809.20   Contents of Court Petition.

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:

   8-809.30   Sworn Statement of Denied Access.

The regulatory authority shall demonstrate to the court by affidavit, sworn testimony, or both that:

   8-809.40   Contents of an Order.

Upon petition of the regulatory authority, the court may issue an inspection order that:

   8-809.50   Optional Contents of an Order.

Upon petition of the regulatory authority, the court may further issue an inspection order that:

Means of Instituting Judicial Enforcement Proceedings

   8-810.10   Institution of Proceedings.

Criminal Proceedings

   8-811.10   Authorities, Methods, Fines, and Sentences.

Injunctive Proceeding

   8-812.10   Petitions for Injunction.

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.

Civil Proceedings

   8-813.10   Petitions, Penalties, and Continuing Violations.


* April 2004 Update: Editorial edits were made to the 2001 Food Code to incorporate the Errata Sheet, corrections since original posting date, and for content accuracy. Links were also added where references exist to other parts/sections of the Food Code, the Code of Federal Regulations, the United States Code, and the Supplement to the 2001 Food Code.

horizontal rule
horizontal rule