Food Law

Accessibility


| Share

Inspections & Audits

This page outlines the expectations of federal and state inspections of food processors, inspection procedures and the government authority to inspect the firm's records. The page also introduces food industry standards and audits/certification.

 

 

Government Inspections

Inspections by regulatory agencies is one means of encouraging compliance with food processing laws.  This section provides a general overview of inspection laws and introduces rules for several specific food products. The following list summarizes some key points

  • At the federal level, USDA FSIS is mandated to conduct ongoing (continuous) inspections of meat and poultry processing; FDA is mandated to conduct periodic inspections of other food processors.
  • States also inspect food facilities in their jurisdiction; these materials use North Dakota as an example of state oversight of food processing.  The North Dakota Department of Health conducts periodic inspections of food manufacturers that are subject to FDA oversight.  The North Dakota Dept. of Agriculture is authorized by USDA FSIS to provide ongoing inspection for meat and poultry processors.
  • Federal and state agencies collaborate/coordinate to reduce the likelihood of regulatory conflict, and to complement each other's oversight efforts.
  • Food firms subject to FDA periodic inspections need to be prepared for an inspection at any time; such firms should have a person on staff who is familiar with the inspection process so that person can 1) accompany an inspector during an inspection and 2) regularly conduct "mock" inspections to assure the firm is operating as required, as well as assuring the firm is always prepared for a government inspection.

 

References for these materials

The following list identifies statutes, regulations and documents relevant to inspections of food processing firms.

USDA Ongoing Inspections

 

FDA Periodic Inspections

 

USDA Meat, Poultry and Egg Inspection -- Statutes

The following excerpts are from the meat, poultry and egg inspection acts.  Note the breadth or scope of activities and products within the jurisdiction of these provisions.

The statute requires "…an examination and inspection of all amenable species before they shall be allowed to enter into any slaughtering, packing, meat-canning, rendering, or similar establishment, in which they are to be slaughtered and the meat and meat food products … are to be used in commerce… " 21 U.S.C. §603(a)

  • 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.

The statute requires "…a post mortem examination and inspection of the carcasses and parts thereof … to be prepared at any slaughtering, meat-canning, salting, packing, rendering, or similar establishment … as articles of commerce which are capable of use as human food;…" 21 U.S.C. §604

  • 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.

"…the Secretary (USDA FSIS) may remove inspectors from any establishment which fails to so destroy any … condemned carcass or part thereof…" 21 U.S.C. §604

  • It is relatively easy to enforce the statutes by removing inspectors if there is an unresolved problem or concern.  Removing the inspectors forces the firm to stop its meat processing because any product processed without inspection will be declared adulterated and illegal to sell.

Inspection "…provisions shall apply to all carcasses or parts of carcasses … meat or meat products … which may be brought into any slaughtering, meat-canning, salting, packing, rendering, or similar establishment, and such examination and inspection shall be had before the … carcasses or parts … shall be allowed to enter into any department … to be treated and prepared for meat food products; and the [inspection] provisions shall also apply to … products, which, after having been issued from any slaughtering, meat-canning, salting, packing, rendering, or similar establishment, shall be returned to … any similar establishment where such inspection is maintained…" 21 U.S.C. §605

  • Meat will be inspected again as it is moved to another facility for further processing

The statute authorizes "…an examination and inspection of all meat food products prepared for commerce in any slaughtering, meat-canning, salting, packing, rendering, or similar establishment, and for the purposes of any examination and inspection and inspectors shall have access at all times, by day or night, whether the establishment be operated or not, to every part of said establishment…" 21 U.S.C. §606

  • Note the broad authority to inspect a meat processing facility extends to times when the plant is not being operated

Inspectors are authorized to inspect "… all slaughtering, meat canning, salting, packing, rendering, or similar establishments in which amenable species are slaughtered and the meat and meat food products thereof are prepared for commerce as may be necessary to inform himself concerning the sanitary conditions of the same, and to prescribe the rules and regulations of sanitation under which such establishments shall be maintained…" 21 U.S.C. §608

  • Note the broad authority to inspect whenever the inspector has concerns about the condition of the facility
  • Note that inspection applies to the animal and meat products, to the facility and to the processing operations

 

The statute requires "…ante mortem inspection of poultry in each official establishment processing poultry or poultry products for commerce…" 21 U.S.C. §455(a)

The statute also requires "…post mortem inspection of the carcass of each bird processed…" 21 U.S.C. §455(b)

  • Note the inspection of poultry before and after slaughter

 

"…whenever [egg] processing operations are being conducted,.. continuous inspection … be made … of the processing of egg products, in each plant processing egg products for commerce,…" 21 U.S.C. §1034(a)

"The Secretary shall refuse to render inspection to any [egg] plant whose premises, facilities, or equipment, or the operation thereof, fail to meet the requirements of this section… " 21 U.S.C. §1035(b)

  • Note the authority to inspect egg processing operations as well as the egg processing facility
  • Note the authority to refuse to inspect if there is a concern about the facility

 

In summary, all livestock and products entering any official establishment and all products prepared therein shall be inspected, handled, stored, prepared, packaged, marked, and labeled as required by USDA FSIS regulations.

  • Official establishment is any slaughtering, cutting, boning, meat canning, curing, smoking, salting, packing, rendering, or similar establishment at which inspection is maintained under USDA FSIS regulations (9 CFR Part 301.2).

 

USDA Meat, Poultry and Egg Inspection -- Regulations

All livestock offered for slaughter shall be examined and inspected on the day of and before slaughter 9 CFR Part 309

A careful post-mortem examination and inspection shall be made of the carcasses and parts thereof of all livestock slaughtered at official establishments. Such inspection and examination shall be made at the time of slaughter 9 CFR Part 310

Processing businesses must apply for USDA inspection; the inspection (as stated above) applies to the facility, the animal, the products, and the processing operations.

 

Application for USDA Inspection -- 9 CFR Part 302 and 9 CFR Part 304

Inspection is required at:

  • establishments in which livestock are slaughtered for transport or sale as articles of commerce, or in which products or carcasses of livestock are prepared for transport or sale in commerce, which are intended for use as human food;
  • establishments at which livestock are slaughtered or products of livestock are prepared, for use as human food solely for distribution within a state; that is, USDA inspection authority extends to intrastate commerce; and
  • establishments designated as producing adulterated products which would clearly endanger the public health.

 

Conditions for receiving inspection:

  • develop written sanitation Standard Operating Procedures as required by 9 CFR Part 416
  • develop written recall procedures as required by 9 CFR Part 418
  • conduct a hazard analysis and develop and validate a HACCP plan as required by 9 CFR Part 417

 

Conditions before producing a new product

  • conduct a hazard analysis and develop a HACCP plan applicable to that product in accordance with 9 CFR Part 417
  • validate its HACCP plan, in accordance with 9 CFR Part 417

 

USDA may refuse to grant inspection if the establishment

  • does not meet the requirements of 9 CFR Parts 304, 305, 307, and 416
  • has not received approval of labeling and containers as required by 9 CFR Parts 316 and 317
  • has not provided a certification that there is reasonable assurance its activity will not violate applicable water quality standards.

 

Preparation of product and other operations may be conducted only by the applicant named in the application.

  • Note, inspection is granted to a particular processing business; other processors cannot proceed by relying on the inspection granted to another processor

 

Re-entry into an Official Establishment

"no product shall be brought into an official establishment unless it has been prepared only in an official establishment and previously inspected and passed by a Program employee, and is identified by an official inspection legend as so inspected and passed." 9 CFR 318.1

This regulation is relevant, for example, when a meat product is moved from one facility to a second facility where the product will then undergo further processing.  The second facility is an official establishment because it is a location where meat or poultry is being processed; therefore, the product needs to meet USDA FSIS regulations before the product may be transported into the second facility for further processing.  Also see

  • 9 CFR 318.2 Reinspection
  • 9 CFR 318.4 Preparation of Products must be Officially Supervised

 

 

Records and Inspection of Records 9 CFR Part 320

  • The processor must maintain records and these records can be inspected/reviewed by the USDA inspector
  • Records to be maintained:

(1) bills of sale, invoices, bills of lading, and receiving and shipping papers,

(i) The name or description of the livestock or article;

(ii) The net weight of the livestock or article;

(iii) The number of outside containers

(iv) The name and address of the buyer of livestock or article sold by such person, and the name and address of the seller of livestock or articles purchased by such person;

(v) The name and address of the consignee or receiver (if other than the buyer);

(vi) The method of shipment;

(vii) The date of shipment; and

(viii) The name and address of the carrier.

(ix) In the case of a person ... slaughtering any swine for use as human or animal food, the name and address (including the city and state, or the township, county, and state) of each person from whom the person ... purchased ... each swine, and the telephone number ... of the person from whom the swine were purchased ..., and all serial numbers and other approved means of identification ... selected at ante mortem inspection ... for residue testing.

(2) Shipper's certificates and permits

(3) A record of seal numbers required to be kept by consignees of inedible products

(5) Guaranties provided by suppliers of packaging materials

(6) Records of canning

(7) Sample results and calculation results as required by processing procedures to destroy trichinae

(8) Records of nutrition labeling

(9) Records required cooked, uncured meat patties (see 9 CFR §318.23(b) and (c))

(10) Records documenting the development, implementation, and maintenance of procedures for the control of the production process using advanced meat/bone separation machinery and meat recovery systems

(11) Records of labeling, product formulas, processing procedures, and any additional documentation needed to show that the labels are consistent with the Federal meat and poultry regulations and policies on labeling

 

Representatives of USDA must be afforded any necessary facilities for the examination and copying of records and for the examination and sampling of inventory.

 

Some Key Points

  • Meat and poultry processing facilities ("official establishments") must be continuously inspected while the plant is operating.
  • An inspector must look at each live animal before slaughter and each carcass after slaughter, as well as watch the overall operation of the plant.
  • Any meat or poultry product processed without inspection is considered adulterated and cannot be sold.
  • The business pays the cost of inspection.

 

 

States’ Role in Meat Inspection

Federal law requires meat and poultry products to be federally inspected, but federal law also provides an exception that a meat or poultry processing facility may select to have state inspection as long as the state has created a state meat and poultry inspection (MPI) program and the state inspection program is "at least equal to" the federal inspection requirements of the Meat Inspection Act and the Poultry Products Inspection Act (Cooperative Agreement). 

Approximately half of the states (27 states) have a state inspection program at this time (2014); see States Operating MPI Programs.  However, meat that is processed by a state inspection program, even though it is "at least equal to" the federal standards, can only be sold intrastate (cite a regulation??). Accordingly, firms in states that have a state MPI program can select federal inspection or state inspection, state inspection might be less expensive, but the state-inspected meat can only be sold in the state.

"Establishments [in state with state MPI programs] have the option to apply for Federal or State inspection.  States [MPI program] operate under a cooperative agreement with FSIS.  States' program must enforce requirements "at  least equal to" those imposed under the Federal Meat and Poultry Products Inspection Acts and the Humane Methods of Slaughter Act of 1978.  However, product produced under State Inspection is limited to intrastate commerce, unless a state opts into an additional cooperative program, the Cooperative Interstate Shipment Program." copied from USDA FSIS web site.

Firms in states without an MPI program are limited to only pursuing federal inspection, but their product is eligible to be sold in interstate commerce; that is, transported to another state.

USDA FSIS is authorized to cooperate with any state in developing and administering  a state MPI program if 1) the state has enacted a law imposing mandatory ante-mortem and post-mortem inspection, re-inspection, and sanitation requirements at least equal to the Federal requirements, and 2) the state inspection program contains authorities at least equal to USDA required records (i.e., registration of specified classes of operators; dead, dying, disabled, or diseased livestock; and products not intended for human food) (9 CFR Part 321).  The FSIS decides whether a state MPI program meets these criteria.  The FSIS provides up to 50% of the state's operating funds, as well as training and other assistance for MPIs that meet the federal criteria (9 CFR Part 321). 

"At Least Equal To” Guidelines for State Meat And Poultry Cooperative Inspection Programs can be found at http://www.fsis.usda.gov/wps/wcm/connect/e257c4af-2a5e-4b50-8e5e-3e8da94af949/At_Least_Equal_to_Guidelines.pdf?MOD=AJPERES

“In their annual self-assessment, State MPI Program Directors are to address each of the following nine program components to demonstrate that the State’s MPI Program constitutes an inspection program that is “at least equal to” the Federal Program… The nine components are …  

  • Component 1. Statutory Authority and Food Safety Regulations
  • Component 2. Inspection
  • Component 3. Product Sampling
  • Component 4. Staffing and Training
  • Component 5. Humane Handling
  • Component 6. Non-Food Safety Consumer Protection
  • Component 7. Compliance
  • Component 8. Civil Rights
  • Component 9. Financial Accountability

 

Exception for State Inspection (CIS Program)

In the 2008 Farm Bill, Congress amended the Meat Inspection Act and Poultry Products Inspection Act authorizing a new inspection program to allow interstate shipment of meat and poultry products from selected state-inspected establishments.  The inspection program, called the Cooperative Interstate Shipment (CIS) program, allows selected small state-inspected establishments, which formerly sold only within the state in which they are located, to reach markets in other states and even foreign countries.

The FSIS is directed to implement and oversee the CIS program by establishing a cooperative inspection program, in coordination with appropriate state agencies, to allow small state-inspected establishments to ship meat and poultry products in interstate commerce (21 U.S.C. 683 and 472).

The selected small firms must be inspected by state inspectors who are trained to meet the federal standards.  Accordingly, the difference between state-inspected product that cannot be sold in an interstate market and state-inspected product that can be sold in an interstate market will be 1) the size of the firm (no larger than 25 employees), 2) the training of the state-inspector (trained to implement the federal standards), and 3) the state inspector's application of the federal standards. 

  • The program is limited to establishments located in States that have established and continue to maintain an “at least equal to” state meat or poultry inspection (MPI) program. 
  • To be eligible, state-inspected establishments must employ 25 or fewer employees; be in compliance with all requirements under the State inspection program and all Federal requirements.
  • Inspection services for these establishments must be provided by state inspection personnel who have "undergone all necessary inspection training and certification to assist USDA FSIS with the administration and enforcement of [the Acts]”.
  • Meat and poultry products inspected and passed by the state inspection personnel will bear a “Federal mark, stamp, tag, or label of inspection” and will be permitted to be shipped in interstate commerce.

The law requires that FSIS designate an FSIS employee to "provide oversight and enforcement" of the program.  If the Federal employee finds that an establishment selected for the program is in violation of the Acts, the FSIS employee is authorized to “deselect the selected establishment or suspend inspection at the establishment”.  The law requires that any selected establishment that FSIS “determines to be in violation of any requirement of the Act, be transitioned to be a Federal establishment”; that is, subject to federal FSIS inspection.  This suggests that state MPI is not an option for a firm that entered the CIS program but then failed to comply with the CIS standards.

  • The difference between a state MPI inspector and a state CIS inspector is that the state MPI inspection only needs to be "at least equal to" federal standards, whereas CIS inspection must fully meet and implement federal standards (cite a reference).
  • The differences between a CIS inspector and a federal inspector also have been described.

References: 

 

USDA Inspection v. USDA 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 [partially] paid for with tax dollars. Grading for quality is voluntary; the service is requested and paid for by meat and poultry producers/processors." Taken from USDA Ask Karen

 

FDA Inspection of “Other” Food Processors

Legal authority for FDA to inspect food processors is based on statutory law enacted by Congress.

Rather than extensive regulations, FDA has incorporated many of its inspection details into agency manuals and guides.

  • FDA is authorized under federal law to inspect any food processing firm that is producing food for interstate commerce.
  • These food processing firms (that is, food processing firms other than meat and poultry processing firms) do NOT need continuous government inspection to operate.
  • FDA, for approximately a decade, has stated the scope of its responsibility/authority as extending to "registered facilities"; that is, all food facilities that must register under the 2002 Bio-Terrorism Act. See 21 U.S.C. §350d.

Registered facilities is emerging as the term which means food firms subject to FDA oversight.

 

"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."

These FDA documents are directed to FDA personnel; but these Manuals provide food businesses 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.

 

FDA Inspection Guides -- the list of Guides reveals some of FDA's inspection responsibilities and activities.

    • Miscellaneous Food Products – the following foods are explicitly addressed in the FDA’s Guide to Inspections of Miscellaneous Food Products.
      • Eggs and Egg Products 
      • Candy Without Chocolate, Candy Specialties, and Chewing Gum
      • Chocolate and Cocoa Products
      • Tree Nuts
      • Peanuts and Peanut Products
      • Vegetable Oils
      • Dressings
      • Vinegar, Cider, Apple Juice
      • Frozen Strawberries
      • Orange, Other Juice
      • Prune Juice
      • Tomato Products
      • Pickles
      • Edible Gelatin (Meat, Meat Products & Poultry)
      • Soft Drinks and Water
      • Baby Food Products
      • Dried Yeast (Food Additives for Human Use)

Additional topics addressed in FDA's Miscellaneous Food Inspection Guide include

    • Storage Facilities
    • Dinnerware (Miscellaneous Food Related Items)
    • Mycotoxins in Foods

Additional FDA Inspection Guides include

Again, an understanding of the guides that apply to a food business should help the firm meet their legal expectations.

 

States’ Role in Inspecting Food Processors

States have the authority to regulate food within its jurisdiction and states have assumed that role.  Federal law is supreme over state law so a difference between a federal expectation for a food processor and a state expectation for a food processor will generally be resolved in that the federal expectation needs to be met.

States generally will inspect food processors on a periodic basis; not much different than FDA’s inspection of food processors.  A practice is that states often inspect more frequently than the FDA; the states attempt to apply expectations similar to the FDA’s expectations/requirements.  If the state discovers a situation that the state cannot resolve, the state will inform the FDA and the FDA will likely commence its own inspection and enforcement action, if necessary.

  • Neither state governments nor FDA have enough resources to frequently inspect these plants, so they try to coordinate their inspection activities and share their information (but this is not a perfect system).  At times, FDA relies on state inspectors to perform routine inspections and then FDA focuses its inspectors on identified problems.  Again, this is not a perfect system and despite Congressional efforts to fund more FDA inspections, there is a recognition that FDA inspections for the foreseeable future are likely to remain focused on responding to problems, rather than conducting routine inspections.
  • State inspection programs also extend to the retail/food service sector; FDA is not authorized to inspect the retail/food service sector.
  • FDA and state inspection programs of the food processing sector includes food warehouse/storage facilities, transportation vehicles, import facilities, and any other location where food is processed, handled, stored, transported, etc.
  • States inspect food processor as part of the state’s licensing requirements; see North Dakota as an example.
    • "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.
  • See Federal/State Integration for several web pages discussing federal, state and local government collaboration addressing food safety. 
  • 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:

Bottom line, state inspections often are relied on for overseeing food processors subject to FDA oversight, and the federal authority (FDA?) is relied on when a problem is identified (often by a state inspector) but not adequately resolved with state enforcement acts.

 

FDA Inspection Practices

Food Drug & Cosmetic Act authorizes the FDA to enter food plants for inspection 21 U.S.C. §374. The following list paraphrases 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.

 

Inspection Plan

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).

 

Responding to Inspection Report -- corrective actions being taken and issues of difference between inspector and firm.

 

 

Employee Training in Assuring Processing Firm Compliance

Implementing these procedures require that the business' employees are aware of their role in assuring the safety of the food product and that they follow the appropriate GMPs, SSOPs, HACCP and Food Safety Plan procedures. Employee training is invaluable in assuring the necessary steps are being taken to minimize the risk of an unsafe food product.

  • For example, training is address as part of mandatory HACCP for juice; see 21 CFR 120.13.
  • Training also is addressed as a component of GMP; see 21 CFR 110.10(c).
  • Likewise in the food processing sector, "Deficient employee training [means] Training that does not meet the following minimum requirements is considered deficient. Training, at a minimum, must include a written policy covering GMPs, personal hygiene, plant sanitation policies and procedures, food safety and quality control policies, and product tampering awareness and consequences. Training must be presented in a language that can be understood by all employees. Training programs should be updated annually and records should be kept of training sessions. All new employees must be provided with initial training that covers the minimum requirements and refresher courses should be provided quarterly. Operational deficiencies should result in additional training."
  • In the food preparation sector of the food industry, the Food Code requires that the "person in charge" has successfully completed an accredited program. see 2-102.11(B) of the 2013 Food Code.

 

Inspection laws for specific food products

—    Seafood inspection 21 U.S.C. §376

  • "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."
  • See Seafood Inspection Program, NOAA, U.S. Dept. of Commerce
  • HACCP plan is mandatory, see 21 CFR 123 (HACCP regulations for seafood products)

 

 

—    Inspection of Dairy Processing Plants and More

Milk products were some of the first foods to be regulated, often by local government such as cities. The dairy industry -- ranging from dairy farmers to dairy processors -- continues to be regulated, often by state and local government. The perishability of the product and its critical role in human food are two reasons for the high level of oversight. North Dakota law is used as an example of state oversight of its dairy industry.

Note that both of these North Dakota regulations reference the Pasteurized Milk Ordinance (PMO).

    • "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 of FDA's Grade A PMO.

The FDA’s PMO “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.”  A brief review of the topics addressed in the PMO illustrates the breadth of the ordinance.

  • Grade "A" Pasteurized Milk Ordinance (Grade "A" PMO)-2009
  • Standards for Grade “A” Raw Milk for Pasteurization, Ultra-Pasteurization or Aseptic Processing
  • Standards for Grade “A” Pasteurized, Ultra-Pasteurized and Aseptically Processed Milk and Milk Products
  • Animal Disease Control
  • Milk Sampling, Hauling, and Transportation
  • Dairy Farm Construction Standards and Milk Production
  • Standards for Water Sources
  • Examples of 3-out-of-5 Compliance Enforcement Procedures
  • Cleaning and Sanitization
  • Chemical and Bacteriological tests
  • Pasteurization Equipment and Procedures and Other Equipment
  • Pasteurization Equipment and Controls – Tests
  • Standards for the Fabrication of Single-Service Containers and Closures for Milk and Milk Products
  • HACCP Program
  • Applicable Regulations, Standards of Identity for Milk and Milk Products and the Federal Food, Drug, And Cosmetic Act
  • Reports and Records
  • Drug Residue Testing and Farm Surveillance
  • Vitamin Fortification of Fluid Milk Products
  • Performance-Based Dairy Farm Inspection System
  • Operation of Automatic Milk Installations for the Production of Grade "A" Raw Milk for Pasteurization
  • Determination of Time/Temperature Control for Safety of Milk and Milk Products

Note that the topics addressed in the PMO range from the health and care of the livestock, through the construction and operation of the farm, to the transportation and processing of the product in the dairy processing facility.  It is appropriate to describe the PMO as "covering the full range of the industry", not just the processing of the dairy product.

.

Industry Standards & Audits

Market expectations often also are imposed as terms in the purchase agreement/contract, such as "I will purchase these food items from your supply firm only if the food and the production practices meet the following standards ..."  To make it easier to assure the supplier is meeting these standards, the food industry is developing standards for food firms to adopt or follow.  To implement these industry standards, the industry also is developing organizations to discuss and establish standards, as well as develop mechanisms to monitor food firms that want to follow such industry standards. These organizations offer the service of inspecting/auditing/certifying that the food firms are operating according to the standards. 

The following list identifies several non-government organizations that provide certification services for the food industry.  Note the similarities between USDA NOP accreditation and certification and these industry audits and certifications.  In both, firms are recognized as capable of inspecting food firms to assure the food firms are complying with the program's standards. The difference is that NOP organic standards are set forth by USDA, whereas industry standards are set forth by participating food businesses.

  • Global Food Safety Initiative (GFSI) -- http://www.mygfsi.com/about-us/about-gfsi/what-is-gfsi.html
    • "The Global Food Safety Initiative (GFSI) is an industry-driven initiative providing thought leadership and guidance on food safety management systems necessary for safety along the supply chain."
  • Global (Good Agricultural Practices) G.A.P. -- http://www.globalgap.org/uk_en/who-we-are/about-us/history/
    • "GLOBALG.A.P.’s ... standards helped producers comply with Europe-wide accepted criteria for food safety, sustainable production methods, worker and animal welfare, and responsible use of water, compound feed and plant propagation materials. Harmonized certification also meant savings for producers, as they would no longer need to undergo several audits against different criteria every year"
  • Safe Quality Food Institute (SQFI) and the SQF Code -- http://www.sqfi.com/about-sqf/
    • "SQF is recognized by retailers and foodservice providers around the world who require a rigorous, credible food safety management system.  Using the SQF certification program will help reduce assessment inconsistencies and costs of multiple assessment standards. The SQF Program is recognized by the Global Food Safety Initiative (GFSI) and links primary production certification to food manufacturing, distribution and agent/broker management certification."
    • SQF Code at http://www.sqfi.com/wp-content/uploads/SQF-Code_Ed-7.2-July.pdf
  • International Organization for Standardization (ISO)  and ISO 22000 -- http://www.22000-tools.com/what-is-iso-22000.html
    • "ISO 22000 is a Food Safety Management System that can be applied to any organization in the food chain, farm to fork. Becoming certified to ISO 22000 allows a company to show their customers that they have a food safety management system in place. This provides customer confidence in the product.
    • "ISO 22000 is not a Global Food Safety Initiative (GFSI) benchmarked standard."
  • Food Safety System Certification (FSSC) and FSSC 22000 -- http://www.fssc22000.com/documents/home.xml?lang=en
    • "FSSC 22000 is fully recognized by the Global Food Safety Initiative (GFSI) and is based on existing ISO Standards. It demonstrates your company has a robust Food Safety Management System in place that meets the requirements of your customers and consumers."

.

Summary

USDA-regulated food products and firms (i.e., meat and poultry processing) are subject to continuous inspection.  Any product subject to USDA inspection that is not inspected during processing is considered adulterated and illegal to sell. If a USDA inspector feels the firm is not operating the plant according to regulatory standards, the inspector can stop inspecting which effectively shuts down the operation because any product processed or produced without inspection is considered adulterated.

FDA-regulated food products and firms are subject to periodic inspection.  These inspections can be unannounced.  The firm should be ready for an inspection at all times, this includes having a staff member prepared to accompany the inspector and the firms records up-to-date and ready for review by the inspector.  The inspector is required to leave a written report/document with the food business at the completion of the inspection. 

Reminder:

  • Official establishments is the term used to mean food processors subject to USDA FSIS oversight.
  • Registered facilities is emerging as the term used to mean food processors subject to FDA oversight.

Food businesses must adhere to government regulations and industry standards.  Government regulations and industry standards often are similar, but not necessarily identical.

.

.

Email David.Saxowsky@ndsu.edu

This material is intended for educational purposes only. It is not a substitute for competent legal counsel. Seek appropriate professional advice for answers to your specific questions.

This material is protected by U.S. copyright laws.

Creative Commons License
Feel free to use and share this content, but please do so under the conditions of our Creative Commons license and our Rules for Use. Thanks.