Processing Practices: HACCP, CGMP, SSOP & Security; Inspections
The topics on this page include
- importance of a detailed flow chart
- expectations imposed by HACCP, cGMP SSOP
- HACCP expectations for specific food products
- facility security
Processing procedures (HACCP and GMP)
As stated previously, federal law prohibits adulterated food from entering interstate commerce. Food is considered adulterated
- If it bears or contains any poisonous or deleterious substance which may render it injurious to health;...
- if it bears or contains any added poisonous or added deleterious substance ... that is unsafe ...
- if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food; or
- if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health; or
- if it is, in whole or in part, the product of a diseased animal or of an animal which has died otherwise than by slaughter; or
- if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health”
- Source 21 USC §342(a)
In general terms, this statute mandates that food companies follow good manufacturing practices (GMP) to assure the processing, storing and transporting environments are clean and that no unacceptable substances enter the food product. This page addresses HACCP which has emerged as an overarching expection for the food processing sector (some commentators would observe that HACCP is tending to be the overarching expectation of the entire food industry).
Hazard Analysis and Critical Control Point
As stated on another web page, Hazard Analysis and Critical Control Points (HACCP) was conceptualized in the 1960s and has assumed a larger role throughout the U.S. and global food industry since that time. Businesses manufacturing or processing specified food products (e.g., meat, poultry, juice, seafood) have been mandated by U.S. federal law for aprpoximately 15 years to adopt HACCP. During that time, the remaining food businesses were given the option of adopting HACCP plans. As of late 2010, Congress enacted legislation that mandates HACCP for all (domestic and foreign?) firms processing food for the United States.
This page addresses HACCP and related food safety concepts. Some of the discussion repeats previous information on this web site; hopefully the repetition will enhance our undestanding.
The 2010 HACCP legislature specifies considerable detail; the level of detail probably reflects the insight gained from implementing HACCP during the past several decades. However, the 2010 legislation did not repeal the prior HACCP statutes. Accordingly, the statutory detail for HACCP from the past (e.g., meat) is less than the statutory detail for HACCP enacted in 2010. Even though there is nothing to prevent firms subject to HACCP in the past from implementing the 2010 statutory details, these firms must be certain that their HACCP plans do not violate the relevant statutory mandates.
- HACCP for meat and poultry processing at 9 CFR part 417
- HACCP for seafood at 21 CFR part 123
- HACCP for juice at 21 CFR part 120
- HACCP for infant formula -- these rules may not fit the typical definition of HACCP, see 21CFR parts 106 & 107
- HACCP for all other food processing -- see 21 USC 350g; regulations were proposed in January 2013.
The HACCP regulations for meat processing ("official") establishments have been in effect for more than a decade and the list of potential hazards reflects the age of the regulations. That is, the hazards mentioned in the older regulations are natural toxins; microbiological contamination; chemical contamination; pesticides; drug residues; zoonotic diseases; decomposition; parasites; unapproved use of direct or indirect food or color additives; and physical hazards.
The 2010 statute (it may be some time before FDA promulgates relevant regulations) lists the following hazards for HACCP analysis: "biological, chemical, physical, and radiological hazards, natural toxins, pesticides, drug residues, decomposition, parasites, allergens, and unapproved food and color additives; hazards that occur naturally, or may be unintentionally introduced; and ... hazards that may be intentionally introduced, including by acts of terrorism..." Certainly, the scope of hazards has expanded with another decade of experience. Note, however, that neither of these lists claim to be a complete listing of hazards the firm needs to consider. The food firms have the opportunity (responsibility?) to identify all risks relevant to their business, even if it is not explicitly listed in the relevant regulations. Accordingly, the meat industry, for example, can use the new statute to supplement or extend the older regulations.
- Overview of HACCP (by FDA)
- A Focus on Hazard Analysis and Critical Control Point (HACCP) (by USDA)
HACCP is described as "a food safety program developed ... for astronauts...; [it] focuses on preventing hazards that could cause food-borne illnesses by applying science-based controls, from raw material to finished products... Traditionally, industry and regulators have depended on spot-checks of manufacturing conditions and random sampling of final products to ensure safe food. This approach, however, tends to be reactive, rather than preventive, and can be less efficient than the new system...
- Places responsibility for ensuring food safety on the food manufacturer or distributor
- Focuses on identifying and preventing hazards from contaminating food
- Is based on sound science
- Permits more efficient and effective government oversight, primarily because the recordkeeping allows investigators to see how well a firm is complying with food safety laws over a period rather than how well it is doing on any given day
- Helps food companies compete more effectively in the world market
- Reduces barriers to international trade.
- HACCP does NOT guarantee safe food. It is a thought process intended to help food firms think about their own activities; to assess their own situation and the associated risks, to develop practices to pre-emptively manage the risks, and to review and revise the effectiveness of those practices. The role of government in HACCP is to provide the mandate (the "stick") to cause reluctant food firms (if any) to adopt HACCP practices. Numerous events can cause food to be unsafe even in a HACCP environment -- a new risk, not fully understanding a known risk, adopting a practice that unknowingly did not fully address the risk, etc.
- A HACCP analysis (and the resulting HACCP plan and its implementation) needs to consider eveything that enters the food facility, that occurs in the food facility and that may occur after the food leaves the facility (to the extent that actions in the food facility can impact what occurs after the food leaves the facility. For example, what enters the food facility includes the food substances, people, air, water, packaging materials, consumable inputs such as sanitizers, occasionally equipment, etc. Has the firm thought about the food safety risks associated with all of these items that enter the food facility, including the undesired entrants such as dust, insects and rodents?
- A second example is to consider everything that occurs in the facility: handling the food substances, storing, moving the substance from storage to processing, the actual processing (often involving numerous steps), moving the manufactured food to storage, and then shipping the products out of the facility.
- Practicing HACCP principles is an ongoing process. Likewise, reviewing and revising practices in the food business is an ongoing effort. HACCP needs to be a culture within each food firm in which everyone is continuously asking "what could occur that would render the food unsafe and what can be done to reduce that risk".
HACCP has been endorsed by the National Academy of Sciences, the Codex Alimentarius Commission ..., and the National Advisory Committee on Microbiological Criteria for Foods. A number of U.S. food companies already use the system in their manufacturing processes, and it is in use in other countries, including Canada."
- Pre-2011 -- HACCP is required for procesing some foods; e.g., meat (9 CFR 417), poultry (also 9 CFR 417), juice (21 CFR 120), and seafood (21 CFR 123.6).
- Post-2011HACCP is reguired for all food processing.
- HACCP has emerged as an industry-driven concept that the firm should take a proactive role in assuring the food processing procedure will lead to a safe product.
- HACCP is considered an alternative to traditional government inspections; but the government retains a role in the overall process by using its regulatory authority to assure that businesses have adequate HACCP plans and that the plan is being appropriately implemented.
- Are these plans pre-approved or are they reviewed only when the facility and records are inspected? For example, see 9 CFR 417.4 for regulations about validating the initial plan -- "the establishment shall conduct activities designed to determine that the HACCP plan is functioning as intended." The responsibility is primarily on the firm; not on the government regulator.
- HACCP allows (requires) each business to focus on their operation and its unique characteristics rather than having a standardized inspection process that may not offer the flexibility to consider the uniqueness of each business. The focus is not on having a standardized production process but on having a monitoring process that is adequate to assure each business (regardless of its manufacturing process) is producing a safe product by minimizing the risk of a food safety problem.
- Seven principles of HACCP; see HACCP Principles
Principle 1: Conduct a hazard analysis.
Principle 2: Determine the critical control points (CCPs).
Principle 3: Establish critical limits (CL).
Principle 4: Establish monitoring procedures.
Principle 5: Establish corrective actions.
Principle 6: Establish verification procedures.
Principle 7: Establish record-keeping and documentation procedures.
- See 21 CFR 123.6(c) for an example of these 7 principles having been incorporated into regulations; these particular regulations address HACCP requirements for fish and fishery products.
- Also see 21 CFR Part 123 Fish and Fishery Products; especially 21 CFR §123.6 (HACCP) and 21 CFR 123.11 (sanitation control procedures (SSOP))
- See FISH AND FISHERIES PRODUCTS, HAZARDS AND CONTROLS GUIDANCE Third Edition June 2001.
Identify, evaluate and prepare a written analysis of known or reasonably foreseeable hazards that may be associated with the facility, including (A) biological, chemical, physical, and radiological hazards, natural toxins, pesticides, drug residues, decomposition, parasites, allergens, and unapproved food and color additives; (B) hazards that occur naturally, or may be unintentionally introduced; and (C) hazards that may be intentionally introduced, including by acts of terrorism.
Comment: note the explicit mention of intentional attacks on the food business.
- The owner, operator, or agent in charge of a facility shall identify and implement preventive controls, including at critical control points, to provide assurances that (1) hazards identified in the hazard analysis will be significantly minimized or prevented; (2) any hazards identified in the hazard analysis will be significantly minimized or prevented and addressed; and (3) the food manufactured, processed, packed, or held by such facility will not be adulterated or misbranded.
- The owner, operator, or agent in charge of a facility shall monitor the effectiveness of the implemented preventive controls to assure that the described outcomes will be achieved.
- The owner, operator, or agent in charge of a facility shall establish procedures to ensure that, if the implemented preventive controls are not properly implemented or are found to be ineffective, (1) appropriate action is taken to reduce the likelihood of recurrence of the implementation failure; (2) all affected food is evaluated for safety; and (3) all affected food is prevented from entering into commerce if the owner, operator or agent in charge of such facility cannot ensure that the affected food is not adulterated or misbranded.
- The owner, operator, or agent in charge of a facility shall verify that (1) the preventive controls implemented are adequate to control the hazards identified; (2) the owner, operator, or agent is conducting monitoring as required by this statute; (3) the owner, operator, or agent is making appropriate decisions about corrective actions taken; (4) the implemented preventive controls are effectively and significantly minimizing or preventing the occurrence of identified hazards, including through the use of environmental and product testing programs and other appropriate means; and (5) there is documented, periodic re-analysis of the plan to ensure that the plan is still relevant to the raw materials, conditions and processes in the facility, and new and emerging threats.
- The owner, operator, or agent in charge of a facility shall maintain, for not less than two years, records documenting the monitoring of the implemented preventive controls, instances of nonconformance material to food safety, the results of testing and other appropriate means of verification, instances when corrective actions were implemented, and the efficacy of preventive controls and corrective actions.
- The owner, operator, or agent in charge of a facility shall prepare a written plan that documents and describes the procedures used by the facility to comply with these requirements, including analyzing the hazards and identifying the adopted preventive controls to address those hazards. Such written plan, together with the documentation, shall be made promptly available to a duly authorized representative of the FDA upon oral or written request.
- The owner, operator, or agent in charge of a facility shall conduct a re-analysis whenever a significant change is made in the activities conducted at a facility if the change creates a reasonable potential for a new hazard or a significant increase in a previously identified hazard, or not less frequently than once every three years, whichever is earlier. Such re-analysis shall be completed and additional preventive controls needed to address the hazard identified, if any, shall be implemented before the change in activities at the facility is operative. The owner, operator, or agent will revise the written plan if such a significant change is made or document the basis for the conclusion that no additional or revised preventive controls are needed. The FDA may require a re-analysis in response to new hazards and developments in scientific understanding, including, as appropriate, results from the Department of Homeland Security biological, chemical, radiological, or other terrorism risk assessment.
Good Manufacturing Practice within HACCP
Good manufacturing practices (GMP) underpinned food processing standards prior to the adoption of HACCP. However, HACCP does not render GMP obsolete. HACCP transitions GMP into a slightly different role than it had prior to HACCP.
Prior to HACCP, the standard for practices in the food industry was "good manufacturing practices" -- GMP. HACCP does not replace GMP. In fact HACCP mentions GMP as an expectation. It may be appropriate to consider HACCP as extending or encompassing GMP.
In the past when GMP was the foundation of government inspections, some GMPs were incorporated into regulations, but frequently in general terms. Other GMPs were recognized and followed, but perhaps never incorporated into regulations. Members of the food industry should consider these past GMPs, whether or not they have part of a regulation, as a source of ideas for operating a food business within the culture of HACCP.
The details for GMP are contained in regulations; for example see 21 CFR part 110;
The regulations address personnel, plant and grounds, sanitary operations, sanitary facilities and controls, equipment and utensils, processes and controls, and warehousing and distribution.
- Topics addressed as part of GMP include disease control; cleaniness; training; supervision; grounds; plant construction and design; general maintenance; cleaning and sanitizing substances; storage of toxic materials; pest control; sanitation of food-contact surfaces; storage and handling of cleaned portable equipment and utensils; water supply; plumbing; sewage disposal; toilet facilities; handwashing facilities; rubbish and offal disposal; equipment, utensil, systems, and instruments design, construction, maintenance and use; food operations; raw materials and ingredients; food manufacturing operations; and storage and transportation.
- Most of these topics appear to primarily relate to paragraph (4), supra.
Also, "[r]egulations known as Good Manufacturing Practices (GMP) limit the amount of food and color additives used in foods. Manufacturers use only the amount of an additive necessary to achieve the desired effect." Excerpt from http://www.cfsan.fda.gov/~dms/qa-adf16.html. Also see the previous section of these materials.
FDA Guidance on GMPs
See "Good Manufacturing Practices (GMPs) for the 21st Century - Food Processing;" consider the Executive Summary as required reading, but also familiarize yourself with the full document.
- Note the suggestions/recommendations of this study.
Need to Address SSOP within HACCP???
Within GMP, and now with HACCP, is the idea of SSOP.
9 CFR 416 -- SOP for meat processing
21 CFR 120.6 -- SSOP for FDA Juice HACCP
Sec. 120.6 Sanitation standard operating procedures.
(a) Sanitation controls. Each processor shall have and implement a sanitation standard operating procedure (SSOP) that addresses sanitation conditions and practices before, during, and after processing. The SSOP shall address:
(1) Safety of the water that comes into contact with food or food contact surfaces or that is used in the manufacture of ice;
(2) Condition and cleanliness of food contact surfaces, including utensils, gloves, and outer garments;
(3) Prevention of cross contamination from insanitary objects to food, food packaging material, and other food contact surfaces, including utensils, gloves, and outer garments, and from raw product to processed product;
(4) Maintenance of hand washing, hand sanitizing, and toilet facilities;
(5) Protection of food, food packaging material, and food contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate, and other chemical, physical, and biological contaminants;
(6) Proper labeling, storage, and use of toxic compounds;
(7) Control of employee health conditions that could result in the microbiological contamination of food, food packaging materials, and food contact surfaces; and
(8) Exclusion of pests from the food plant.
- Although GMP may directly deal primarily with 21 USC §342(a)(4), supra, GMPs can also be implemented to minimize the risk of food being adulterated as the result of any of the other conditions, such as paragraphs 1, 2, 3, 5, or 6 of 21 USC §342(a), supra.
HACCP and Storage/Transportation
HACCP is not limited processing facilities. It also encompasses storage and transportation.
- FDA -- rely on state inspections? FDA's mandate is for occasional inspections; FDA does not have the staff to conduct more inspections; most food businesses are subject to state license requirements and thus occasional state inspections (see previous section). Accordingly, FDA inspections generally are conducted after a problem has been identified.
- USDA -- required to conduct ongoing inspections of meat and poultry processing facilities. The ongoing inspections should be an opportunity for USDA inspectors to continuously monitor whether the firm is following GMP.
The Breadth of FDA HACCP Activities Seafood, Land Foods, & Retail
- Mandatory HACCP for seafood and juice
- Voluntary HACCP for dairy (Grade A) and other land foods
- Also, FDA is urging that HACCP principles be applied to retail and food service sectors of the food industry -- discussed again in next section of these materials
- Recall that HACCP also is being suggested for the production sector.
- "FDA operates a mandatory safety program for all fish and fishery products..."
- "FDA's ... regulations (21 CFR 123) ... require processors of fish and fishery products to develop and implement Hazard Analysis Critical Control Point (HACCP) systems for their operations."
- See FDA's Fish and Fisheries Products Hazards and Controls Guidance; additional guides and background information is available at Seafood: Guidance for Industry and Seafood Regulations & Guidance.
- Also see National Marine Fisheries Service (NOAA Fisheries)
"The FDA operates an oversight compliance program for fishery products under which responsibility for the product's safety, wholesomeness, identity and economic integrity rests with the processor or importer, who must comply with regulations promulgated under the Federal Food, Drug and Cosmetic (FD&C) Act, as amended, and the Fair Packaging and Labeling Act (FPLA). In addition, FDA operates the Low-Acid Canned Food (LACF) program which is based on the Hazard Analysis Critical Control Point (HACCP) concept, and is focused on thermally processed, commercially sterile foods, including seafood such as canned tuna and salmon. Most FDA in-plant inspections consider product safety, plant/food hygiene and economic fraud issues..." excerpt from a previous web page
HACCP for juice 21 CFR Part 120
- HACCP for juices (FDA) -- "The Food and Drug Administration today [January 18, 2001] announced a final rule designed to improve the safety of fruit and vegetable juice and juice products. Under the rule, juice processors must use Hazard Analysis and Critical Control Point (HACCP) principles for juice processing. Implementation of a HACCP system will increase the protection of consumers from illness-causing microbes and other hazards in juices." Excerpt from http://www.cfsan.fda.gov/~lrd/hhsjuic4.html
"All juice (as defined in 21 CFR 120.1(a)) sold as juice or for use as an ingredient in other beverages is subject to the requirements of the juice HACCP regulation, with the exception of juice produced at a retail establishment ..." excerpt from Guidance for Industry: Juice HACCP Hazards and Controls...
- See 21 CFR 120
- Also see Juice HACCP and Guidance Documents (e.g., 2001, 2003, 2004, 2005, 2007)
- For a summary of discussions that led to these regulations, see NACMCF Recommendations on Fresh Juice.
FSIS HACCP for Meat & Poultry
- Hazard Analysis and Critical Control Point (HACCP) Systems for meat 9 CFR part 417
- See 9 CFR 417.2 (HACCP plan for animals and animal products)
- HACCP for meat (FSIS) -- "Every official [meat] establishment shall conduct, or have conducted for it, a hazard analysis to determine the food safety hazards reasonably likely to occur in the production process and identify the preventive measures the establishment can apply to control those hazards. 9 CFR 417.2
- Official establishment: "Any slaughtering, cutting, boning, meat canning, curing, smoking, salting, packing, rendering, or similar establishment at which inspection is maintained under the regulations in this subchapter." 9 CFR 301.2
- List of plants under federal inspection (FSIS)
Expansion of HACCP
The expanding acceptance of HACCP suggests that it may someday extend across the entire food industry (production, processing, and preparation) and around the world (for example, see Codex and ISO).
Is HACCP voluntary or mandatory? Pre-2011, HACCP was mandatory only for processing seafood, juice, meat and poultry. Post-2010, HACCP is mandatory for processing all foods.
Regulatory agencies involved with HACCP include FDA, USDA, and various state agencies. International organizations also are promoting HACCP, see Codex and ISO.
HACCP is intended to assure product safety, but it can also lead to improved product quality.
HACCP can generally be implemented with a 12-step process
Step #1 Assemble a HACCP Team
- A commitment from management.
- Multidisciplinary membership.
- Know the manufacturing process and the products
- Know how to take corrective action.
- Understand the HACCP principles.
Step #2 Processing and Distribution of Foods
- A separate HACCP is needed for each product.
- What method will be used for distributing the product?
- Refrigerated or frozen or shelf-stable?
- Safety hazard or quality issue?
Step #3 Intended Use and Consumers
- What impact will the product have on the general public?
- Are you targeting a specific segment of the market? Particular consumers? Are you targeting a wholesale or retail market.
- Lower fat products
Step #4 Develop a Flow Diagram
- Must cover all steps of the manufacturing process.
- Not an engineering drawing.
- Verify the accuracy and completeness of the flow diagram.
- Take the diagram to the production floor to assure/verify its accuracy.
Step #5 Conduct a Hazard Analysis
- Are you concerned about microbiological, chemical or physical hazards?
- Identify steps in the manufacturing process where a hazard can happen.
- Consider risk (probability) of the hazard and severity if the hazard occurs.
- Remember -- hazard is limited to safety; it does not focus on quality issues (even though they may be related).
- Identify preventative measures that can be applied.
Step #6 Critical Control Points (CCP)
- CCP -- any place in the manufacturing and distribution process where control can be applied to prevent a hazard.
- GMP’s can and should control many hazards.
- What is a CCP for one product many not be for another.
Step #7 Critical Limits (CL)
- Limit that must be met to insure safety of the product.
- Exceeding the CL means a health hazard exists.
- CLs can be derived from regulatory standards (e.g., dairy), guidelines, studies, experts, etc.
- Examples of CLs: temperatures (for some products it may be what is too high and for other products it may be what is too low), time, pH, residues, bacteria counts and kinds.
Step #8 Monitoring/Inspection
- Planned sequence of observations or measurements.
- Must control CCP’s
- Must be effective.
- Monitoring intervals must be reliable.
- Must be rapid, no lengthy analysis.
- Adequate plan to see that the monitoring is carried out.
Step #9 Corrective Actions
- Specify procedures to be taken when deviations occur.
- Corrective actions must be documented.
- Eliminate actual or potential hazards.
- Be prepared to put products on hold if a problem is identified.
- Make changes to prevent future occurrence.
Step #10 Records
- Must include every part of the HACCP program, from team membership through all actions -- steps #1 - 12
Step #11 Verification
- Consists of methods, procedures or tests used in monitoring compliance.
- CCP’s are under control
- Necessary changes have been made.
- All records are complete.
- Sample analysis to verify.
- Training and knowledge.
Step #12 Evaluation and Revision
- At least an annual review.
- Anytime manufacturing process is changed or products are changed.
- Anytime new raw materials or sources are used.
- Anytime formulation is changed.
- Anytime new equipment is installed; in some cases, even adjusting the performance of the equipment may necessitate are review of the HACCP..
- Anytime there is a change in personnel or shifts.
- Anytime there is a changes in storage or distribution.
Assessing vulnerabilities to an intentional attack within a food system or infrastructure
Since September 2001, there has been increased focus on the risk of an intentional attack on the U.S. food system. The industry recognized that the military assesses the risk of an intentional attack on a continuous basis. The process used by the military is known as CARVER. Throughout the 2000s, the U.S. food industry studied the application of CARVER. The 2010 food safety legislation incorporates intentional attack into the most recent definition of HACCP. This section reviews CARVER and begins to suggest how it might be incorporated into HACCP.
How does a food business begin to address the risk of an intentional attack on its product? One emerging idea is to implement the military's concept of CARVER.
"CARVER is an acronym for the following six attributes ... used to evaluate the attractiveness of a target for attack:
- Criticality - measure of public health and economic impacts of an attack
- Accessibility – ability to physically access and egress from target
- Recuperability – ability of system to recover from an attack
- Vulnerability – ease of accomplishing attack
- Effect – amount of direct loss from an attack as measured by loss in production
- Recognizability – ease of identifying target
In addition, the modified CARVER tool evaluates a seventh attribute, the combined health, economic, and psychological impacts of an attack, or the SHOCK attributes of a target."
FDA web page on CARVER + Shock
" [CARVER + Shock] allows the user to think like an attacker to identify the most attractive targets for an [intentional] attack. By conducting a CARVER + Shock assessment of a food production facility or process, the user can determine the most vulnerable points in their infrastructure, and focus resources on protecting the most susceptible points in their system."
A statement about CARVER from several years ago:
"As many of you know, FDA has developed both an operational risk management strategy and what we refer to as the CARVER process to assess the vulnerability of all segments of the food system. With CARVER, we break a particular food system into its smallest pieces (nodes) in the farm to table continuum. We then analyze each node and identify the “critical nodes” that are most likely targets for terrorist attack. Identification of the “critical nodes” then leads to development of countermeasures to reduce the risk at these nodes.
"The food Industry has demonstrated tremendous leadership in working with FDA to assess individual commodity production and delivery vulnerabilities. To date we have conducted CARVER analyses with the International Bottled Water Association (IBWA), the Food Processors Assoc. (NFPA), the Juice Products Association (JPA), and the Dairy Foods Association (IDFA). These industry groups have truly been leaders and examples of this partnership to improve the security of the nation’s food supply."
Another statement about CARVER from several years ago:
“Another area where we have made food security improvements is in assessing vulnerabilities from the farm to the table. FSIS has completed a vulnerability assessment for domestic products to determine the most vulnerable products, likely agents, and potential sites for deliberate contamination. A similar assessment is being conducted for imported products.
"Through this initial vulnerability assessment, we identified four commodities as being high-risk. Then, a working group created under the IFWG … conducted a detailed vulnerability assessment on these four products using a Department of Defense targeting method called CARVER + Shock. It is an offensive technique in that it identifies physical locations an enemy might find advantageous to introduce contaminants by evaluating the target through the enemy’s eyes.
“These assessments are powerful risk management tools that can be used to develop strategies and policies that reduce or eliminate the potential risk at vulnerable points along the farm-to-table continuum. Once you identify where a target may be, we can develop shields, or counter measures, to address the vulnerabilities identified.“
USDA Food Defense Plan -- guide sheet for food businesses
FDA Food Defense -- web-based information describing several approaches to addressing the concern of intentional attacks on the food industry
The FDA shall a) conduct a vulnerability assessment of the food system; b) consider the best available understanding of uncertainties, risks, costs, and benefits associated with guarding against intentional adulteration of food; c) determine the types of science-based mitigation strategies or measures that are necessary to protect against the intentional adulteration of food; and d) determine the time, manner, and form in which these determinations are made publicly available.
- The FDA shall promulgate regulations a) specifying how a person shall assess whether the person is required to implement mitigation strategies to protect against intentional adulteration of food; and b) specify appropriate science-based mitigation strategies to protect the food supply chain at specific vulnerable points. These regulations shall apply only to food for which there is a high risk of intentional contamination.
This section does not apply to farms, except for those that produce milk.
- As of March 2013, these regulations have NOT yet been promulgated.
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.
The focus in this section is on inspection of the food processing sector. The following list summarizes some key points.
Meat and Poultry Processing Inspections
- Inspection of meat and poultry processing is based on U.S. federal meat inspection and poultry inspection laws.
- 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.
- Federal law allows states to establish meat or poultry inspection programs; standards for state inspection programs must be at least equal to federal inspection standards. USDA decides whether a state inspection program meets this criterion.
- Meat and poultry processing firms in states with a state inspection program have the option of choosing either federal inspection or state inspection; state inspection might be less expensive, but federal inspection is needed for the product to be eligible for interstate commerce.
- Meat and poultry processing firms in states without a state inspection program have no option but to use federal inspection, however, their product will be eligible for interstate commerce.
- See Slaughter Inspection 101at http://www.fsis.usda.gov/factsheets/Slaughter_Inspection_101/index.asp.
"Other Food Processing" Inspections
This discussion focuses on food processing firms other than those processing meat and poultry.
Most states (probably all states) regulate food processing firms; for example, many states require these firms be licensed by the state. The states also allow state regulators to regularly inspect food processing firms.
FDA also is authorized under federal law to inspect any food processing firm that is producing food for interstate commerce.
Note that these food processing firms (that is, food processing firms other than meat and poultry processing firms) do NOT need continuous government inspection to operate.
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 recognizition that FDA inspections for the foreseeable future are likely to remain focused on responding to problems, rather than conducting routine inspections.
We need to recognize that state inspection programs also extend to the retail/food service sector; FDA is not authorized to inspect the retail/food service sector.
We also must recognize that 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.
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.
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.
- Guide to Inspections of Manufacturers of Miscellaneous Food Products- Vol.1
- Guide to Inspections of Manufacturers of Miscellaneous Food Products- Vol. 2
- FDA's Investigations Operations Manual; for example, note Chapter 5 -- Establishment Inspections, and subchapter 5.4 Food at http://www.fda.gov/ICECI/Inspections/IOM/ucm122532.htm
- " The IOM is the primary guidance document on FDA inspection policy and procedures for field investigators and inspectors."
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.
FDA Inspection Responsibilities
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.
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.
State role in inspecting food establishments
- States do most of the inspecting as part of their licensing requirements; see North Dakota as an example.
- 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.
- 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.
Inspection laws for specific food products
As introduced previously, 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
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
- For example: Minnesota's Meat, Poultry & Egg Inspection
- "Meat and poultry business operators who wish to sell their products to other businesses are required to be under continuous inspection. This means that their process is inspected every day during operations to ensure they are producing safe food. For example, in a slaughter operation, every animal must be inspected to determine that the meat comes from an animal free from signs of disease. Continuous inspection is required for any business that wishes to sell their products to other retail outlets, such as grocery stores, restaurants or other food service institutions. Businesses that need to have this type of inspection usually have two options for inspection)." Taken from Meat and Poultry Inspection Requirements
- Minnesota Statutes §31A.03 Inspection of live animals
- Minnesota Statutes §31A.04 Inspection of carcasses
Poultry Protection Inspection Act (PPIA)
- USDA authority is similar to meat ; 21 U.S.C. §§451-471; 9 CFR Part 381
- PPIA Inspection of processing facilities ; 21 U.S.C. §§451-471; 9 CFR Part 381
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)
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."
- 21 CFR 123 (HACCP regulations for seafood products)
- Requires HACCP plan
- See Seafood Inspection Program, NOAA, U.S. Dept of Commerce
Inspection of Dairy plants
- Grade A
- Inspection Criteria for Grade A Plants (N.D.A.C.)
- Other than Grade A
The food industry must take an active (leadership?) role in assuring its products are as safe as possible. HACCP can be considered a culture that will lead to action: "what could cause the food to be rendered unsafe and what needs to be done to reduce the risk of that happening."