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Records and Inspections
This page addresses the topics of recordkeeping and inspections relating to the broad topic of food safety. On-site inspections by regulatory agencies are a long-time practice for assuring that businesses are complying with legal mandates. Similarly, firms can provide information about their practices by maintaining records of their business activities.
A practice (a requirement) in the area of food law is that firms maintain records relating to the manufacture, processing, packing, distribution, receipt, holding, or importation of food products. The purpose is to assist in the determination of whether anything has happened to the food or been done to the food that would render unsafe (i.e., adulterated). Accordingly, firms must maintain the records and government authorities may access the records.
- Maintenance and inspection of records 21 U.S.C. 350c
- “(a) Records inspection. If the Secretary has a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals, each person (excluding farms and restaurants) who manufactures, processes, packs, distributes, receives, holds, or imports such article shall ... permit [FDA] employee ... access to and copy all records relating to such article that are needed to assist … in determining whether the food is adulterated … The requirement … applies to all records relating to the manufacture, processing, packing, distribution, receipt, holding, or importation of such article maintained by … such person in any format (including paper and electronic formats) and at any location.“
- The focus of this statute is not to specify which records need to be maintained, but to indicate that the regulatory agencies can access any records that the firm decides to maintain (certain financial records are not accessible and the agencies must take steps to protect the firm's confidential information).
- However, the statute implies the types of records that firms are likely to maintain.
- Would it be appropriate to describe the purpose of maintaining records as "to help determine the source and scope/magnitude of a food safety problem?" If that is an appropriate statement of purpose, what records would you recommend that a food business maintain? Why those records?
- A subsequent section of these materials addresses the question of the firm's legal obligations or liabilities to its customers who consume an unsafe product. Would the failure to maintain appropriate records increase the firm's liability to consumers if the firm devised a recordkeeping system that was not adequate to support a recall of an unsafe food product? Restated, does product liability law (rather than food safety statutes) establish which records a firm should maintain?
- Examples of statutes and regulations mandating records:
- Business managers should review the regulations for their products to determine what records are required.
- Traceability – “(b) Regulations concerning recordkeeping. The Secretary ... may by regulation establish requirements regarding the establishment and maintenance, for not longer than two years, of records by persons (excluding farms and restaurants) who manufacture, process, pack, transport, distribute, receive, hold, or import food ... needed ... to identify the immediate previous sources and the immediate subsequent recipients of food, including its packaging, in order to address credible threats of serious adverse health consequences or death to humans or animals ...“
- Subsection (b) was added by the Bioterrorism Act of 2002 and took effect in late 2003. This requirement is sometimes referred to as "traceability;" that is, the path the food followed can be traced based on the "source" and "recipient" information maintained by food businesses.
- Note the exception for farms and restaurants.
- This mandatory record process bears similarities to the marketing strategy of identity preservation (IP).
- Can this record/tracing process be used to fulfill both objectives?
- Will the market demand that food be "traceable" back to the producer (even though the statute exempts farms)?
What information/records does the international market expect in terms of tracing the movement of a product through the food industry? What is being mandated in other nations?
- EUROPA General Food Law -- Traceability
- "The Regulation contains general provisions for traceability (applicable from 1 January 2005) which cover all food and feed, all food and feed business operators, without prejudice to existing legislation on specific sectors such as beef, fish, GMOs etc. Importers are similarly affected as they will be required to identify from whom the product was exported in the country of origin. Unless specific provisions for further traceability exist, the requirement for traceability is limited to ensuring that businesses are at least able to identify the immediate supplier of the product in question and the immediate subsequent recipient, with the exemption of retailers to final consumers (one step back-one step forward)."
- Also see Guidance on the Implementaion of Articles 11, 12, 16, 17, 18, 19 and 20 of Regulation (EC) No 178/2002 on General Food Law at http://ec.europa.eu/food/food/foodlaw/guidance/guidance_rev_7_en.pdf; note pages 9 to 15 of the pdf file, pertaining to article 18.
- Fact Sheet on Food Traceability
- Can our previous activities (e.g., tracing organic commodities and foods) help us devise an acceptable process for tracing the movement of other foods?
- Will the trend towards container shipments, rather than bulk or commodity shipments, impact this trend? That is, will the regulatory requirement of traceability, the market desire for traceability, and the transportation technology of "containers" converge? Will the ability to seal a container at its point of loading advance the cause of traceability?
- Again, will the market demand that food be "traceable" back to the producer? See EurepGAP.
Not the same as labeling even though it is part of the packaging; coding is intended to help identify the source of the food item.
Food firms are allowed to develop their own coding system. The firms decide the level of detail. For example, do they want to be able to identify the time of day of processing, or just the shift during which the food was processed? More detail allows the firm to "pin point" when a product was processed, but each level of detail perhaps adds cost to the business operation.
Government inspections are another strategy for assuring food businesses are operating in a sanitary manner. This section provides a general overview of inspection laws and an introduction to rules for several specific food products.
- Many of the inspection requirements are based on federal law but are implemented in collaboration with state agencies. For example, North Dakota law specifies minimum inspection requirements:
"Every ... food establishment ... must be inspected at least once every two years by the [state department of health]. Food establishments ... must be inspected based on a system of risk categorization which involves types of foods served, the preparation steps these foods require, volume of food, population served, and previous compliance history. The [state department of health] and its inspectors may enter any such establishment at reasonable hours to determine compliance with this chapter." N.D.C.C. §23-09-11.
The following points illustrate some inspection requirements under federal law.
Note that federal inspection laws are found in statutes and agency manuals; not necessarily in regulations.
FDA Inspection Responsibilities
FDCA authorizes the FDA to enter food plants for inspection 21 U.S.C. §374. The following paragraphs paraphrase the relevant federal statutes.
- The inspection process generally involves the inspector 1) presenting credentials, 2) conducting the inspection, 3) meeting with a representative of the business, and 4) preparing and providing an inspection report.
- FDA officers or employees, upon presenting appropriate credentials and a written notice to the owner, operator, or agent in charge, may enter and inspect, at reasonable times, any factory, warehouse, or establishment in which food is manufactured, processed, packed, or held for interstate commerce, or any vehicle being used to transport or hold such food.
- FDA, upon presenting appropriate credentials and a written notice, has authority to enter [and inspect], at reasonable times [and within reasonable limits and in a reasonable manner], any factory, warehouse, or establishment in which food ... are manufactured, processed, packed, or held, for ... interstate commerce [and] to enter [and inspect] any vehicle being used to transport or hold food ... for interstate commerce; and inspect all pertinent equipment, finished and unfinished materials, containers, and labeling therein.
- A separate notice shall be given for each inspection, but a notice shall not be required for each entry made during the period covered by the inspection. Each inspection shall be commenced and completed with reasonable promptness.
Note the breadth of this authorization.
Preparing for inspections – food businesses should have a plan that identifies who is authorized to review credentials; who will accompany inspector; who will respond to request for documents; whether the company will allow photographs, tape recordings, employee interviews; the rate that will be charged for samples; who will respond to inspection report; and in what situations will legal counsel be contacted.
- The inspections must be conducted at reasonable times, within reasonable limits, and in a reasonable manner. The inspection may encompass the factory, warehouse, establishment, or vehicle and all pertinent equipment, finished and unfinished materials, containers, and labeling.
Limit of inspections -- photographs, recordings, employee interviews are not permitted unless business (implicitly or explicitly) agrees to allow them.
- In the case of any person (excluding farms and restaurants) who manufactures, processes, packs, transports, distributes, holds, or imports foods, the inspection shall extend to all records and other information when the FDA employee has a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals. See 21 U.S.C. §374(a).
- In the case of any person (excluding farms and restaurants) who manufactures, processes, packs, transports, distributes, holds, or imports foods, the inspection shall extend to all records and other information described in [21 USC 350c] when the Secretary has a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals ... No inspection ... shall extend to financial data, sales data other than shipment data, pricing data, personnel data (other than data as to qualification of technical and professional personnel performing functions subject to this chapter), and research data...
- Business records that may be inspected include any records/information needed to assist the FDA in determining whether the suspected food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals. This includes record of immediate previous sources and immediate subsequent recipients of food, including its packaging. However, the FDA must take appropriate measures to prevent the unauthorized disclosure of any trade secret or confidential information that is obtained by FDA as part of the inspection, including recipes for food, financial data, pricing data, personnel data, research data, or sales data (other than shipment data regarding sales). See 21 U.S.C. §350c.
- Upon completing the inspection and prior to leaving the premises, the inspector must provide the owner, operator, or agent in charge a written report setting forth any conditions or practices observed by the inspector which, in the inspector's judgment, indicates that any food in the establishment consists, in whole or in part, of any filthy, putrid, or decomposed substance, or has been prepared, packed, or held under unsanitary conditions whereby it may become contaminated or rendered injurious to health. A copy of such report shall be sent promptly to the Secretary.
- If the inspector obtained any sample during the inspection, upon completing the inspection and prior to leaving the premises, the inspector shall give the owner, operator, or agent in charge a receipt describing the samples obtained.
- Whenever in the course of any inspection ... [a sample is taken] and an analysis is made ..., a copy of the results of such analysis shall be furnished promptly to the owner, operator, or agent in charge. See 21 U.S.C. §374 (b), (c) and (d).
Other relevant web sites:
- FDA: Food Compliance Programs
"Compliance programs are documents prepared by FDA's Centers that provide guidance to the Agency's field offices in carrying out investigations, inspections, sample collections, sample analyses, and regulatory activities in defined program areas, such as domestic seafood and pesticides in domestic foods for example. "
- FDA’s Guide to Inspections
- "Guide to Inspections of: ... Foods ... " Note: These documents are reference material for investigators and other FDA personnel. The documents do not bind FDA and do not confer any rights, privileges, benefits or immunities for or on any person(s). An alternative approach may be used if such an approach satisfies the applicable statutes, regulations or both.
These FDA documents are directed to FDA personnel, they provide food businesses with insight as to how FDA views its responsibilities and how FDA intends to fulfill those responsibilities. With this understanding, food businesses should be able to better prepare their practices to comply with FDA's expectations.
State role in inspecting food establishments
- States do most of the inspecting as part of their licensing requirements; see the North Dakota example presented in previous sections of this page.
- also see, Dairy, Food & Meat Inspection Division in the Minnesota Department of Agriculture
- See Partnerships & Contracts for several web pages discussing federal, state and local government collaboration addressing food safety. This collaboration is formalized with "partnership agreements" and "state inspection contracts."
- "The following Grade "A" PMO, with Appendices, is recommended for legal adoption by States, Counties, and Municipalities, in order to encourage a greater uniformity and a higher level of excellence of milk sanitation practice in the United States. An important purpose of this recommended standard is to facilitate the shipment and acceptance of milk and milk products of high sanitary quality in interstate and intrastate commerce." Excerpt from Introduction.
Responding to Inspection Report -- corrective actions being taken and issues of difference between inspector and firm.
Inspection laws for specific food products
A major exception to the general inspection laws administered by FDA is the meat and poultry inspection laws administered by USDA.
Meat Inspection Act, 1906
21 U.S.C. §§601-695; 9 CFR Parts 301 et seq.
Congress requires that USDA continuously inspect the operations of meat an poultry processing facilities. This is different than the occasional or "spot" inspection of other food businesses; see previous description of FDA inspection practices.
- Meat products must be inspected by USDA in the manufacturing plant/facility. The meat processing plant cannot be operated if the USDA inspector is not present. Likewise, the meat processing business cannot sell its product in interstate commerce unless it has been approved by a USDA inspector.
To prevent the use of adulterated meat and meat food products, USDA appoints inspectors to examine and inspect all cattle, sheep, swine, goats, horses, mules, and other equines before they enter a slaughtering, packing, meat-canning, rendering, or similar establishment . All cattle, sheep, swine, goats, horses, mules, and other equines found to show symptoms of disease shall be set apart and slaughtered separately from all other animals, and the carcasses of these animals shall be subject to a careful examination and inspection ... paraphrased from 21 U.S.C. §603(a). Also see Ante-Mortem Inspection 9 CFR Part 309.
USDA inspectors will conduct a post mortem examination and inspection of the carcasses and parts thereof of all cattle, sheep, swine, goats, horses, mules, and other equines to be prepared at any slaughtering, meat-canning, salting, packing, rendering, or similar establishment in any State ... which are capable of use as human food. The carcasses and parts thereof of all such animals found to be not adulterated shall be marked ... as ''Inspected and passed.' The inspectors shall label as ''Inspected and condemned'' all carcasses and parts of animals found to be adulterated; and all carcasses condemned shall be destroyed for food purposes by the establishment in the presence of an inspector. The USDA may remove its inspectors from any such establishment which fails to ... destroy any such condemned carcass ... paraphrased from 21 U.S.C. §604. Also see Post-Mortem Inspection 9 CFR Part 310.
Meat inspection regulations 9 CFR 302.1
- Examine carcasses brought into slaughtering or packing establishments
- Examine meat food products returned to packing establishments
- Inspectors of meat food products; marks of inspection; destruction of condemned products; products for export
- Sanitation regulations under Meat Inspection Act 9 CFR Part 416
- FSIS Inspection Programs
- "Under authority of the Federal Meat, Poultry and Egg Products Inspection Acts, FSIS inspects and monitors all meat, poultry and egg products sold in interstate and foreign commerce to ensure compliance with mandatory U.S. food safety standards and inspection legislation."
- Link to specific Information for federally-inspected processing establishments, including egg processing establishments and foreign establishments.
- Meat inspection is a federal/state collaborative effort.
- "Establishments have the option to apply for Federal or State inspection. Under the agreement, a State's program must enforce requirements "at least equal to" those imposed under the Federal Meat and Poultry Products Inspection Acts. However, product produced under State inspection is limited to intrastate commerce. FSIS provides up to 50% of the State's operating funds, as well as training and other assistance." Taken from State Inspection Programs
- 9 CFR Part 321 - regulations addressing FSIS cooperation with states. "... cooperation is authorized if the jurisdiction has enacted a law imposing mandatory ante-mortem and post-mortem inspection, reinspection, and sanitation requirements at least equal to the Federal requirements ..."
- Requirements for State-Federal Inspection Programs
- List of states currently operating a meat/poultry inspection (MPI) program
Poultry Protection Inspection Act (PPIA)
Inspection v. Grading
"The inspection and grading of meat and poultry are two separate programs within the U.S. Department of Agriculture (USDA). Inspection for wholesomeness is mandatory and is paid for out of tax dollars. Grading for quality is voluntary, and the service is requested and paid for by meat and poultry producers/processors." Taken from Frequently Asked Questions About Food Safety from the USDA Meat and Poultry Hotline
Egg Protection Inspection Act (EPIA)
- "The Secretary, upon application of any packer of any sea food for shipment or sale within the jurisdiction of this chapter, may, at his discretion, designate inspectors to examine and inspect such food and the production, packing, and labeling thereof. If on such examination and inspection compliance is found with the provisions of this chapter and regulations promulgated thereunder, the applicant shall be authorized or required to mark the food as provided by regulation to show such compliance. Services under this section shall be rendered only upon payment by the applicant of fees fixed by regulation in such amounts as may be necessary to provide, equip, and maintain an adequate and efficient inspection service."
- 21 CFR 123 (HACCP regulations for seafood products)
- Requires HACCP plan
- See Seafood Inspection Program, US Dept of Commerce
Inspection of Dairy plants
- Grade A
- Other than Grade A
Review of Agency Action
Is there a limit to what an inspector can do? Can a business appeal an inspector’s determination? Is there an administrative review process? Is there a judicial review process?
- For example, see 21 CFR Part 10; 10.25, 10.33, part 16, and 10.45
- Talk to agency; request hearing; then commence lawsuit (appeal to the judicial system). Cite a court case?
April 16, 2010