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Prevention, Inspection, and Risk

Given the enormous challenges that inspection poses as a regulatory strategy for ensuring food safety, the past sevearl decades have seen a push towards alternative tools to protect the food supply.  Three themes are commonly observed in policy debates.  First, an emphasis on risk estimation.  Although sometimes connoting particular quantitative methods, the basic idea is straightforward.  The particular risks posed to the food supply should be identified and estiamted. Without knowing—and often quantifying—what the risks of contamination or adulteration are, it is difficult to protect against them.   Second, resources should be allocated to points in the food chain that are particularly vulnerable.  Rather than inspecting every egg both before and after cracking, target locations or moments of particular vulnerability to contamination. Or, rely more extensively on auditing and sampling methods.  Third, decentralize the formulation of hazard prevention and response to regulated parties. Most food etablishments must today parepare a Hazard Analysis Critical Control Point plan. An overview is included below. While a HACCP sounds technical, it is really nothing more than working through what and where the risks to food safety are in a given facility and making a plan on how to prevent and respond.  Over time, federal agencies increasingly oversee the formulation and adoption of these private plans for food safety action rather than imposing particular requirements in rules or regulations.  One way of understanding this trend is as a shift away from command and control regulatory tools.  In the environmental policy domain, this has meant relying on performance controls that leave it up to regulated parties to decide how to best reduce pollution to a given level, rather than technology controls that demand a particular kind of scrubber be used to reduce pollution.   In the food context, rather than relying on finished product inspectino, the HACCP model is a systematic preventative appraoch to food safety that addresses physical, chemical, and biological hazards at each stage of the food production process. HACCP is thus a methodological innovation and it is used by both USDA and FDA.  

Although HACCP has only recently found favor with government regulators, it has been around at least since the 1950s, apparently developed jointly by the Pillsbury Company and the National Aeronautics and Space Administration (NASA), who needed safe food that could be consumed in space. See Food Code 2001, Recommendations of the United States Public Health Service, Food and Drug Administration 424 (2001). Down on earth, Pillsbury introduced the HACCP system after food safety problems with their baby food. See William H. Sperber and Richard F. Stier, Happy 50th Birthday to HACCP: Retrospective and Prospective, Food Sfaety Mag. (2009/2010). In the mid 1980's, the National Academy of Sciences (NAS) wrote that “government agencies responsible for control of microbiological hazards in foods should promulgate appropriate regulations that would require industry to utilize the HACCP systems in their food protection programs.” An Evaluation of the Role of Microbiological Criteria for Foods and Food Ingredients 329, National Research Council, National Academy of Sciences (1985).  FDA adopted the HACCP principles for seafood inspection in 1995, followed by the USDA for meat and poultry inspection in 1997. Roberts, Food Law at 142.       

 

  • 1 HACCP Principles & Application Guidelines

    1

    Introduction

    2

    HACCP is a management system in which food safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product. For successful implementation of a HACCP plan, management must be strongly committed to the HACCP concept. A firm commitment to HACCP by top management provides company employees with a sense of the importance of producing safe food.

    3

    HACCP is designed for use in all segments of the food industry from growing, harvesting, processing, manufacturing, distributing, and merchandising to preparing food for consumption. Prerequisite programs such as current Good Manufacturing Practices (cGMPs) are an essential foundation for the development and implementation of successful HACCP plans. Food safety systems based on the HACCP principles have been successfully applied in food processing plants, retail food stores, and food service operations. The seven principles of HACCP have been universally accepted by government agencies, trade associations and the food industry around the world.

    4

    The following guidelines will facilitate the development and implementation of effective HACCP plans. While the specific application of HACCP to manufacturing facilities is emphasized here, these guidelines should be applied as appropriate to each segment of the food industry under consideration.

    5

    * * * 

    6

    Education and Training

    7

    The success of a HACCP system depends on educating and training management and employees in the importance of their role in producing safe foods. This should also include information the control of foodborne hazards related to all stages of the food chain. It is important to recognize that employees must first understand what HACCP is and then learn the skills necessary to make it function properly. Specific training activities should include working instructions and procedures that outline the tasks of employees monitoring each CCP.

    8

    Management must provide adequate time for thorough education and training. Personnel must be given the materials and equipment necessary to perform these tasks. Effective training is an important prerequisite to successful implementation of a HACCP plan.

    9

    Developing a HACCP Plan

    10

    The format of HACCP plans will vary. In many cases the plans will be product and process specific. However, some plans may use a unit operations approach. Generic HACCP plans can serve as useful guides in the development of process and product HACCP plans; however, it is essential that the unique conditions within each facility be considered during the development of all components of the HACCP plan.

    11

    In the development of a HACCP plan, five preliminary tasks need to be accomplished before the application of the HACCP principles to a specific product and process. The five preliminary tasks are given in Figure 1.

    12

    Figure 1. Preliminary Tasks in the Development of the HACCP Plan

    Preliminary Tasks in the Development of the HACCP Plan

    14

    Assemble the HACCP Team

    15

    The first task in developing a HACCP plan is to assemble a HACCP team consisting of individuals who have specific knowledge and expertise appropriate to the product and process. It is the team's responsibility to develop the HACCP plan. The team should be multi disciplinary and include individuals from areas such as engineering, production, sanitation, quality assurance, and food microbiology. The team should also include local personnel who are involved in the operation as they are more familiar with the variability and limitations of the operation. In addition, this fosters a sense of ownership among those who must implement the plan. The HACCP team may need assistance from outside experts who are knowledgeable in the potential biological, chemical and/or physical hazards associated with the product and the process. However, a plan which is developed totally by outside sources may be erroneous, incomplete, and lacking in support at the local level.

    16

    Due to the technical nature of the information required for hazard analysis, it is recommended that experts who are knowledgeable in the food process should either participate in or verify the completeness of the hazard analysis and the HACCP plan. Such individuals should have the knowledge and experience to correctly: (a) conduct a hazard analysis; (b) identify potential hazards; (c) identify hazards which must be controlled; (d) recommend controls, critical limits, and procedures for monitoring and verification; (e) recommend appropriate corrective actions when a deviation occurs; (f) recommend research related to the HACCP plan if important information is not known; and (g) validate the HACCP plan.

    17

    Describe the food and its distribution

    18

    The HACCP team first describes the food. This consists of a general description of the food, ingredients, and processing methods. The method of distribution should be described along with information on whether the food is to be distributed frozen, refrigerated, or at ambient temperature.

    19

    Describe the intended use and consumers of the food

    20

    Describe the normal expected use of the food. The intended consumers may be the general public or a particular segment of the population (e.g., infants, immunocompromised individuals, the elderly, etc.).

    21

    Develop a flow diagram which describes the process

    22

    The purpose of a flow diagram is to provide a clear, simple outline of the steps involved in the process. The scope of the flow diagram must cover all the steps in the process which are directly under the control of the establishment. In addition, the flow diagram can include steps in the food chain which are before and after the processing that occurs in the establishment. The flow diagram need not be as complex as engineering drawings. A block type flow diagram is sufficiently descriptive (see Appendix B). Also, a simple schematic of the facility is often useful in understanding and evaluating product and process flow.

    23

    Verify the flow diagram

    24

    The HACCP team should perform an on-site review of the operation to verify the accuracy and completeness of the flow diagram. Modifications should be made to the flow diagram as necessary and documented.

    25

    After these five preliminary tasks have been completed, the seven principles of HACCP are applied.

    26

    Conduct a hazard analysis (Principle 1)

    27

    After addressing the preliminary tasks discussed above, the HACCP team conducts a hazard analysis and identifies appropriate control measures. The purpose of the hazard analysis is to develop a list of hazards which are of such significance that they are reasonably likely to cause injury or illness if not effectively controlled. Hazards that are not reasonably likely to occur would not require further consideration within a HACCP plan. It is important to consider in the hazard analysis the ingredients and raw materials, each step in the process, product storage and distribution, and final preparation and use by the consumer. When conducting a hazard analysis, safety concerns must be differentiated from quality concerns. A hazard is defined as a biological, chemical or physical agent that is reasonably likely to cause illness or injury in the absence of its control. Thus, the word hazard as used in this document is limited to safety.

    28

    A thorough hazard analysis is the key to preparing an effective HACCP plan. If the hazard analysis is not done correctly and the hazards warranting control within the HACCP system are not identified, the plan will not be effective regardless of how well it is followed.

    29

    The hazard analysis and identification of associated control measures accomplish three objectives: Those hazards and associated control measures are identified. The analysis may identify needed modifications to a process or product so that product safety is further assured or improved. The analysis provides a basis for determining CCPs in Principle 2.

    30

    The process of conducting a hazard analysis involves two stages. The first, hazard identification, can be regarded as a brain storming session. During this stage, the HACCP team reviews the ingredients used in the product, the activities conducted at each step in the process and the equipment used, the final product and its method of storage and distribution, and the intended use and consumers of the product. Based on this review, the team develops a list of potential biological, chemical or physical hazards which may be introduced, increased, or controlled at each step in the production process. Appendix C lists examples of questions that may be helpful to consider when identifying potential hazards. Hazard identification focuses on developing a list of potential hazards associated with each process step under direct control of the food operation. A knowledge of any adverse health-related events historically associated with the product will be of value in this exercise.

    31

    After the list of potential hazards is assembled, stage two, the hazard evaluation, is conducted. In stage two of the hazard analysis, the HACCP team decides which potential hazards must be addressed in the HACCP plan. During this stage, each potential hazard is evaluated based on the severity of the potential hazard and its likely occurrence. Severity is the seriousness of the consequences of exposure to the hazard. Considerations of severity (e.g., impact of sequelae, and magnitude and duration of illness or injury) can be helpful in understanding the public health impact of the hazard. Consideration of the likely occurrence is usually based upon a combination of experience, epidemiological data, and information in the technical literature. When conducting the hazard evaluation, it is helpful to consider the likelihood of exposure and severity of the potential consequences if the hazard is not properly controlled. In addition, consideration should be given to the effects of short term as well as long term exposure to the potential hazard. Such considerations do not include common dietary choices which lie outside of HACCP. During the evaluation of each potential hazard, the food, its method of preparation, transportation, storage and persons likely to consume the product should be considered to determine how each of these factors may influence the likely occurrence and severity of the hazard being controlled. The team must consider the influence of likely procedures for food preparation and storage and whether the intended consumers are susceptible to a potential hazard. However, there may be differences of opinion, even among experts, as to the likely occurrence and severity of a hazard. The HACCP team may have to rely upon the opinion of experts who assist in the development of the HACCP plan.

    32

    Hazards identified in one operation or facility may not be significant in another operation producing the same or a similar product. For example, due to differences in equipment and/or an effective maintenance program, the probability of metal contamination may be significant in one facility but not in another. A summary of the HACCP team deliberations and the rationale developed during the hazard analysis should be kept for future reference. This information will be useful during future reviews and updates of the hazard analysis and the HACCP plan.

    33

    * * * 

    34

    Upon completion of the hazard analysis, the hazards associated with each step in the production of the food should be listed along with any measure(s) that are used to control the hazard(s). The term control measure is used because not all hazards can be prevented, but virtually all can be controlled. More than one control measure may be required for a specific hazard. On the other hand, more than one hazard may be addressed by a specific control measure (e.g. pasteurization of milk).

    35

    For example, if a HACCP team were to conduct a hazard analysis for the production of frozen cooked beef patties (Appendices B and D), enteric pathogens (e.g., Salmonella and verotoxin-producing Escherichia coli) in the raw meat would be identified as hazards. Cooking is a control measure which can be used to eliminate these hazards. * * *

    36

    The hazard analysis summary could be presented in several different ways. One format is a table***. Another could be a narrative summary of the HACCP team's hazard analysis considerations and a summary table listing only the hazards and associated control measures.

    37

    Determine critical control points (CCPs) (Principle 2)

    38

    A critical control point is defined as a step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level. The potential hazards that are reasonably likely to cause illness or injury in the absence of their control must be addressed in determining CCPs.

    39

    Complete and accurate identification of CCPs is fundamental to controlling food safety hazards. The information developed during the hazard analysis is essential for the HACCP team in identifying which steps in the process are CCPs. One strategy to facilitate the identification of each CCP is the use of a CCP decision tree***. Although application of the CCP decision tree can be useful in determining if a particular step is a CCP for a previously identified hazard, it is merely a tool and not a mandatory element of HACCP. A CCP decision tree is not a substitute for expert knowledge.

    40

    Critical control points are located at any step where hazards can be either prevented, eliminated, or reduced to acceptable levels. Examples of CCPs may include: thermal processing, chilling, testing ingredients for chemical residues, product formulation control, and testing product for metal contaminants. CCPs must be carefully developed and documented. In addition, they must be used only for purposes of product safety. For example, a specified heat process, at a given time and temperature designed to destroy a specific microbiological pathogen, could be a CCP. Likewise, refrigeration of a precooked food to prevent hazardous microorganisms from multiplying, or the adjustment of a food to a pH necessary to prevent toxin formation could also be CCPs. Different facilities preparing similar food items can differ in the hazards identified and the steps which are CCPs. This can be due to differences in each facility's layout, equipment, selection of ingredients, processes employed, etc.

    41

    Establish critical limits (Principle 3)

    42

    A critical limit is a maximum and/or minimum value to which a biological, chemical or physical parameter must be controlled at a CCP to prevent, eliminate or reduce to an acceptable level the occurrence of a food safety hazard. A critical limit is used to distinguish between safe and unsafe operating conditions at a CCP. Critical limits should not be confused with operational limits which are established for reasons other than food safety.

    43

    Each CCP will have one or more control measures to assure that the identified hazards are prevented, eliminated or reduced to acceptable levels. Each control measure has one or more associated critical limits. Critical limits may be based upon factors such as: temperature, time, physical dimensions, humidity, moisture level, water activity (aw), pH, titratable acidity, salt concentration, available chlorine, viscosity, preservatives, or sensory information such as aroma and visual appearance. Critical limits must be scientifically based. For each CCP, there is at least one criterion for food safety that is to be met. An example of a criterion is a specific lethality of a cooking process such as a 5D reduction in Salmonella. The critical limits and criteria for food safety may be derived from sources such as regulatory standards and guidelines, literature surveys, experimental results, and experts.

    44

    An example is the cooking of beef patties * * * . The process should be designed to ensure the production of a safe product. The hazard analysis for cooked meat patties identified enteric pathogens (e.g., verotoxigenic E. coli such as E. coli O157:H7, and salmonellae) as significant biological hazards. Furthermore, cooking is the step in the process at which control can be applied to reduce the enteric pathogens to an acceptable level. To ensure that an acceptable level is consistently achieved, accurate information is needed on the probable number of the pathogens in the raw patties, their heat resistance, the factors that influence the heating of the patties, and the area of the patty which heats the slowest. Collectively, this information forms the scientific basis for the critical limits that are established. Some of the factors that may affect the thermal destruction of enteric pathogens are listed in the following table. In this example, the HACCP team concluded that a thermal process equivalent to 155° F for 16 seconds would be necessary to assure the safety of this product. To ensure that this time and temperature are attained, the HACCP team for one facility determined that it would be necessary to establish critical limits for the oven temperature and humidity, belt speed (time in oven), patty thickness and composition (e.g., all beef, beef and other ingredients). Control of these factors enables the facility to produce a wide variety of cooked patties, all of which will be processed to a minimum internal temperature of 155° F for 16 seconds. In another facility, the HACCP team may conclude that the best approach is to use the internal patty temperature of 155° F and hold for 16 seconds as critical limits. In this second facility the internal temperature and hold time of the patties are monitored at a frequency to ensure that the critical limits are constantly met as they exit the oven. The example given below applies to the first facility.* * * 

    45

    Establish monitoring procedures (Principle 4)

    46

    Monitoring is a planned sequence of observations or measurements to assess whether a CCP is under control and to produce an accurate record for future use in verification. Monitoring serves three main purposes. First, monitoring is essential to food safety management in that it facilitates tracking of the operation. If monitoring indicates that there is a trend towards loss of control, then action can be taken to bring the process back into control before a deviation from a critical limit occurs. Second, monitoring is used to determine when there is loss of control and a deviation occurs at a CCP, i.e., exceeding or not meeting a critical limit. When a deviation occurs, an appropriate corrective action must be taken. Third, it provides written documentation for use in verification.

    47

    An unsafe food may result if a process is not properly controlled and a deviation occurs. Because of the potentially serious consequences of a critical limit deviation, monitoring procedures must be effective. Ideally, monitoring should be continuous, which is possible with many types of physical and chemical methods. For example, the temperature and time for the scheduled thermal process of low-acid canned foods is recorded continuously on temperature recording charts. If the temperature falls below the scheduled temperature or the time is insufficient, as recorded on the chart, the product from the retort is retained and the disposition determined as in Principle 5. Likewise, pH measurement may be performed continually in fluids or by testing each batch before processing. There are many ways to monitor critical limits on a continuous or batch basis and record the data on charts. Continuous monitoring is always preferred when feasible. Monitoring equipment must be carefully calibrated for accuracy.

    48

    Assignment of the responsibility for monitoring is an important consideration for each CCP. Specific assignments will depend on the number of CCPs and control measures and the complexity of monitoring. Personnel who monitor CCPs are often associated with production (e.g., line supervisors, selected line workers and maintenance personnel) and, as required, quality control personnel. Those individuals must be trained in the monitoring technique for which they are responsible, fully understand the purpose and importance of monitoring, be unbiased in monitoring and reporting, and accurately report the results of monitoring. In addition, employees should be trained in procedures to follow when there is a trend towards loss of control so that adjustments can be made in a timely manner to assure that the process remains under control. The person responsible for monitoring must also immediately report a process or product that does not meet critical limits.

    49

    All records and documents associated with CCP monitoring should be dated and signed or initialed by the person doing the monitoring.

    50

    When it is not possible to monitor a CCP on a continuous basis, it is necessary to establish a monitoring frequency and procedure that will be reliable enough to indicate that the CCP is under control. Statistically designed data collection or sampling systems lend themselves to this purpose.

    51

    Most monitoring procedures need to be rapid because they relate to on-line, "real-time" processes and there will not be time for lengthy analytical testing. Examples of monitoring activities include: visual observations and measurement of temperature, time, pH, and moisture level.

    52

    Microbiological tests are seldom effective for monitoring due to their time-consuming nature and problems with assuring detection of contaminants. Physical and chemical measurements are often preferred because they are rapid and usually more effective for assuring control of microbiological hazards. For example, the safety of pasteurized milk is based upon measurements of time and temperature of heating rather than testing the heated milk to assure the absence of surviving pathogens.

    53

    With certain foods, processes, ingredients, or imports, there may be no alternative to microbiological testing. However, it is important to recognize that a sampling protocol that is adequate to reliably detect low levels of pathogens is seldom possible because of the large number of samples needed. This sampling limitation could result in a false sense of security by those who use an inadequate sampling protocol. In addition, there are technical limitations in many laboratory procedures for detecting and quantitating pathogens and/or their toxins.

    54

    Establish corrective actions (Principle 5)

    55

    The HACCP system for food safety management is designed to identify health hazards and to establish strategies to prevent, eliminate, or reduce their occurrence. However, ideal circumstances do not always prevail and deviations from established processes may occur. An important purpose of corrective actions is to prevent foods which may be hazardous from reaching consumers. Where there is a deviation from established critical limits, corrective actions are necessary. Therefore, corrective actions should include the following elements: (a) determine and correct the cause of non-compliance; (b) determine the disposition of non-compliant product and (c) record the corrective actions that have been taken. Specific corrective actions should be developed in advance for each CCP and included in the HACCP plan. As a minimum, the HACCP plan should specify what is done when a deviation occurs, who is responsible for implementing the corrective actions, and that a record will be developed and maintained of the actions taken. Individuals who have a thorough understanding of the process, product and HACCP plan should be assigned the responsibility for oversight of corrective actions. As appropriate, experts may be consulted to review the information available and to assist in determining disposition of non-compliant product.

    56

    Establish verification procedures (Principle 6) 

    57

    Verification is defined as those activities, other than monitoring, that determine the validity of the HACCP plan and that the system is operating according to the plan. The NAS (1985) pointed out that the major infusion of science in a HACCP system centers on proper identification of the hazards, critical control points, critical limits, and instituting proper verification procedures. These processes should take place during the development and implementation of the HACCP plans and maintenance of the HACCP system. * * * 

    58

    One aspect of verification is evaluating whether the facility's HACCP system is functioning according to the HACCP plan. An effective HACCP system requires little end-product testing, since sufficient validated safeguards are built in early in the process. Therefore, rather than relying on end-product testing, firms should rely on frequent reviews of their HACCP plan, verification that the HACCP plan is being correctly followed, and review of CCP monitoring and corrective action records.

    59

    Another important aspect of verification is the initial validation of the HACCP plan to determine that the plan is scientifically and technically sound, that all hazards have been identified and that if the HACCP plan is properly implemented these hazards will be effectively controlled. Information needed to validate the HACCP plan often include (1) expert advice and scientific studies and (2) in-plant observations, measurements, and evaluations. For example, validation of the cooking process for beef patties should include the scientific justification of the heating times and temperatures needed to obtain an appropriate destruction of pathogenic microorganisms (i.e., enteric pathogens) and studies to confirm that the conditions of cooking will deliver the required time and temperature to each beef patty.

    60

    Subsequent validations are performed and documented by a HACCP team or an independent expert as needed. For example, validations are conducted when there is an unexplained system failure; a significant product, process or packaging change occurs; or new hazards are recognized.

    61

    In addition, a periodic comprehensive verification of the HACCP system should be conducted by an unbiased, independent authority. Such authorities can be internal or external to the food operation. This should include a technical evaluation of the hazard analysis and each element of the HACCP plan as well as on-site review of all flow diagrams and appropriate records from operation of the plan. A comprehensive verification is independent of other verification procedures and must be performed to ensure that the HACCP plan is resulting in the control of the hazards. If the results of the comprehensive verification identifies deficiencies, the HACCP team modifies the HACCP plan as necessary.

    62

    Verification activities are carried out by individuals within a company, third party experts, and regulatory agencies. It is important that individuals doing verification have appropriate technical expertise to perform this function. The role of regulatory and industry in HACCP was further described by the NACMCF (1994) (3).

    63

    * * *

    64

    Establish record-keeping and documentation procedures (Principle 7)

    65

    * * *

    66

     

    67
    IMPLEMENTATION AND MAINTENANCE OF THE HACCP PLAN
    68

    The successful implementation of a HACCP plan is facilitated by commitment from top management. The next step is to establish a plan that describes the individuals responsible for developing, implementing and maintaining the HACCP system. Initially, the HACCP coordinator and team are selected and trained as necessary. The team is then responsible for developing the initial plan and coordinating its implementation. Product teams can be appointed to develop HACCP plans for specific products. An important aspect in developing these teams is to assure that they have appropriate training. The workers who will be responsible for monitoring need to be adequately trained. Upon completion of the HACCP plan, operator procedures, forms and procedures for monitoring and corrective action are developed. Often it is a good idea to develop a timeline for the activities involved in the initial implementation of the HACCP plan. Implementation of the HACCP system involves the continual application of the monitoring, record-keeping, corrective action procedures and other activities as described in the HACCP plan.

    69

    Maintaining an effective HACCP system depends largely on regularly scheduled verification activities. The HACCP plan should be updated and revised as needed. An important aspect of maintaining the HACCP system is to assure that all individuals involved are properly trained so they understand their role and can effectively fulfill their responsibilities.

  • 2 American Federation of Government Employees, AFL-CIO v. Glickman, 215 F.3d 7 (D.C. Cir. 2000).

    American Federation of Government Employees entails a challenge FSIS's move to the HACCP model.

    Notes: <p>1. Text. The court holds that relying on establishment personnel rather than government employees to inspect poultry violates the text of the <span class="caps">PPIA</span>. The statutory text says that the Secretary shall cause to be made by inspectors appointed for that purpose a post-mortem examination and inspection of the carcasses and parts thereof of all [livestock] to be prepared at any slaughtering, &#8230; or similar establishment&#8230;.” 21 U.S.C. § 604). For poultry, § 455(b) of the <span class="caps">PPIA</span> states: “[t]he Secretary, whenever processing operations are being conducted, shall cause to be made by inspectors post mortem inspection of the carcass of each bird processed&#8230;.” 21 U.S.C. § 455(b). Is the text of the statute so clear that an &#8220;inspector&#8221; must be a government employee?</p> <p>2. Text and Purpose. Would it matter to the court if it could be definitively shown that the new inspection regime was vastly superior to the old in terms of avoiding adulteration?</p> <p>3. Umpires and Pitchers. The court notes that the government believes an inspector can perform an inspection by watching another person perform an inspection. On this logic, urges the court, an umpire is a pitcher because an umpire watches a pitcher pitch. Does this metaphor seem on point? Surely an inspector could watch her own employees perform tasks like testing or observing chickens and still be performing the role of inspecting. Nevertheless, a unanimous panel held that the task of inspection could not be delegated to private employees without running afoul of the <span class="caps">FMIA</span> and the <span class="caps">PPIA</span>.</p>
    1
    Before: EDWARDS, Chief Judge, RANDOLPH and GARLAND, Circuit Judges.
    2
    Opinion
    Opinion for the Court filed by Circuit Judge RANDOLPH.
     
    RANDOLPH, Circuit Judge:
    The Federal Meat Inspection Act (“FMIA”), 21 U.S.C. § 604, and the Poultry Products Inspection Act (“PPIA”), 21 U.S.C. § 455, require inspectors appointed by the Department of Agriculture (“USDA”) to perform a “post-mortem inspection” of the carcasses and parts of all livestock and birds processed for human consumption. The question in this appeal from the judgment of the district court is whether the statutes permit federal inspectors to step back from the processing lines and perform their inspection duties by overseeing inspections conducted by plant employees.
     
    I
    Inspectors from the USDA's Food Safety and Inspection Service (“FSIS”) generally conduct post-mortem inspections while stationed at fixed points along the slaughter processing line. Using organoleptic methods, that is, relying on sight, touch and smell, the inspectors examine the head, viscera, and exterior of each carcass for signs of adulteration, such as tumors, inflammation, parasites, and other diseases. See 9 C.F.R. pts. 310–11, §§ 381.76–94. If the inspector detects no signs of adulteration, the carcass is passed and marked with the USDA legend. See 9 C.F.R. §§ 310.8, 381.79. Under the FMIA, if the inspector finds any lesion or other condition “that might render the *9 **9 meat or any part unfit for food purposes, or otherwise adulterated,” the carcass (and its parts) must be retained for veterinary disposition. 9 C.F.R. § 310.3. A carcass or part found to “be unsound, unhealthful, unwholesome, or otherwise adulterated” is condemned and marked as such. Id. § 310.5. Similar procedures apply to inspections under the PPIA. See id. §§ 381.81–89.
     
    The method of inspection just described had remained unchanged for decades. Then, in the mid–1990s, FSIS embarked on a comprehensive food safety initiative targeting the agency's resources at what it perceived as a serious health risk—foodborne pathogens, such as salmonella and E. coli, which cannot be detected by organoleptic inspection. At the same time it determined to make changes in the current inspection process to combat these microbial causes of foodborne illness, FSIS addressed what it considered to be another failure of the present regulatory system—that it provides processing plants with little incentive to detect and eliminate unacceptable carcasses before presenting them for inspection. For these reasons, FSIS decided to require “industry to assume responsibility for producing safe products, reducing foodborne pathogens, and ... to shift Agency inspection resources to those areas which present the greatest public health risk.” John W. McCutcheon Decl. at ¶ 10.
     
    In July 1996, FSIS took the first step in implementing its new initiative by promulgating the Pathogen Reduction/Hazard Analysis and Critical Control Points (“HACCP”) final rule. See 61 Fed.Reg. 38,806 (1996). The rule “requires plants to implement science-based process control systems as a means of preventing food safety hazards, sets certain food safety performance standards, and establishes testing programs to ensure those standards are met.” Food Safety and Inspection Service, HACCP–Based Inspection Models 1 (1998). It provides the industry with complete control over production decisions and execution, subject only to the performance standards set by FSIS. FSIS believes that heightening the industry's responsibility for safe meat and poultry products will increase “the incentives and flexibility establishments need to innovate and improve food safety.” HACCP Final Rule, 61 Fed.Reg. 38,808.
     
    Such advances, according to FSIS, cannot be achieved without substantial changes to its approach to inspection. As the agency put it, the roles of establishments and federal inspectors need to be “realigned to accord with the HACCP philosophy.” Id. To design and test new inspection models, FSIS initiated the Inspection Models Development Project (the “Models Project”). Under the regulatory framework proposed in the Models Project, the task of separating normal from abnormal carcasses and parts will be carried out solely by industry personnel. Federal inspectors will be responsible for monitoring the plant's performance in sorting and for verifying its compliance with performance standards and regulatory requirements. Under the new model, a finding that a product is not adulterated will be based on FSIS's determination that the establishment's food safety and sanitation control systems are preventing adulteration.1
     
    Under the new inspection models, FSIS has said that “slaughter process control will be an industry responsibility subject to FSIS oversight and verification.” HACCP–Based Meat and Poultry Inspection Concepts: In–Plant Slaughter Inspection Models Study Plan, 63 Fed.Reg. 40,381, 40,381 (1998). It explained, “[e]stablishment employees will conduct anatomical *10 **10 and pathological examinations of carcasses, and FSIS inspectors will oversee, evaluate, and verify the effectiveness and reliability of the establishments' slaughter process controls.” Id. FSIS plans the transition to industry-based inspection to occur in stages. At the outset, establishment employees will only be responsible for identifying and removing trimmable defects. They will later assume responsibility for generalized condemnable conditions. And at the final stage, employees will perform “all tasks related to slaughter control,” with the inspectors' role limited to oversight and verification. Food Safety and Inspection Service, HACCP–Based Inspection Models Project In–Plant Slaughter 10 (1998).
     
    Draft guidance put out by FSIS gives some indication of what oversight and verification entails. Though the descriptions vary slightly depending on the class of animals, oversight amounts to inspectors observing establishment personnel as they process carcasses and remove unacceptable products from the food supply. By verification, FSIS means that inspectors will randomly sample and examine carcasses that have been passed to determine if the establishment is complying with the relevant performance standards.
     
    The appellants are a group of federal meat and poultry inspectors, their union, and the Community Nutrition Institute. They brought this suit to enjoin the Secretary from “authorizing anything other than the carcass-by-carcass postmortem inspection by a federal government inspector.” Brief for Appellants at 5. Following cross-motions for summary judgment, the district court ruled in the government's favor on the basis that the word “inspection” did not clearly require an organoleptic inspection. See American Fed'n of Gov't Employees, AFL–CIO v. Glickman, No. 98–0893, Memorandum and Order (D.D.C. Sept. 23, 1999).
     
    II
    The statutory language with which we are concerned, the language supposedly allowing FSIS's oversight and verification regime, is as follows. For meat, § 604 of the FMIA provides: “the Secretary shall cause to be made by inspectors appointed for that purpose a post-mortem examination and inspection of the carcasses and parts thereof of all [livestock] to be prepared at any slaughtering, ... or similar establishment....” 21 U.S.C. § 604 (emphasis added). For poultry, § 455(b) of the PPIA states: “[t]he Secretary, whenever processing operations are being conducted, shall cause to be made by inspectors post mortem inspection of the carcass of each bird processed....” 21 U.S.C. § 455(b) (emphasis added).
     
    The government does not deny that in the ninety or so years since passage of the FMIA in 1907, “inspection” has been taken to mean an organoleptic examination of the carcass, an inspection, that is, using the senses. Now the government has discovered another meaning. A “federal employee has performed an inspection of a carcass,” the government tells us, “when he has watched a plant employee conduct the kind of examination, organoleptic or otherwise, that is necessary to determine whether the carcass is fit for human consumption. And in making these observations, the oversight inspector will observe all of the carcasses that pass along the slaughter line.” Brief for the Appellees at 29.
     
    In other words, the government believes that federal employees fulfill their statutory duty to inspect by watching others perform the task. One might as well say that umpires are pitchers because they carefully watch others throw baseballs. The government thinks it can arrive at its position on the basis that the word “inspection” is undefined in the statutes. But the lack of a statutory definition does not render a term ambiguous. See Bass v. Stolper, Koritzinsky, Brewster & Neider, S.C., 111 F.3d 1322, 1325 (7th Cir.1997). It simply leads us to give the term its ordinary, common meaning. See Perrin v. *11 **11 United States, 444 U.S. 37, 42, 100 S.Ct. 311, 62 L.Ed.2d 199 (1979); Johnson v. SEC,87 F.3d 484, 487 (D.C.Cir.1996). And when we treat the word “inspection” in that manner, it is easy to see why there is nothing to the government's point that “an oversight inspector will necessarily observe all carcasses and parts that pass along the slaughter line.” See John W. McCutcheon Decl. at ¶ 21. Every inspection entails an observation, but not every observation amounts to an inspection. One may observe something without paying close attention to it, and without giving it a critical appraisal, although that is what these statutes demand. The military commander may observe his troops without inspecting them. The foreman of an assembly line may do the same with widgets.
     
    Both statutes clearly contemplate that when inspections are done, it will be federal inspectors—rather than private employees—who will make the critical determination whether a product is adulterated or unadulterated.2 To the extent federal employees are doing any systematic inspecting under the Models Project, they are inspecting people not carcasses. Delegating the task of inspecting carcasses to plant employees violates the clear mandates of the FMIA and PPIA. See Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837, 842–43, 104 S.Ct. 2778, 81 L.Ed.2d 694 (1984). For that reason, we reverse the grant of summary judgment and remand to the district court for further proceedings consistent with this opinion.
    So ordered.
    3
     
    Notes. 
    4
    The Models Project encompasses several phases. The first phase involves collecting baseline data of current performance under federal inspection in order to ensure that the new system achieves similar standards. This is followed by a period of testing the new inspection models at certain volunteer plants. Testing began in three such plants in September 1999, and FSIS has set tentative start-up dates for eighteen others.
    “The term ‘inspector’ means: (1) an employee or official of the United States Government ..., or (2) any employee or official of the government of any State....” 21 U.S.C. § 453(k).
  • 3 Supreme Beef Processors, Inc. v. U.S. Dept. of Agriculture, 275 F.3d 432 (5th Cir. 2001).

    1
    PATRICK E. HIGGINBOTHAM, Circuit Judge:
     
    Certain meat inspection regulations promulgated by the Secretary of Agriculture, which deal with the levels of Salmonellain raw meat product, were challenged as beyond the statutory authority granted to the Secretary by the Federal Meat Inspection Act. The district court struck down the regulations. We hold that the regulations fall outside of the statutory grant of rulemaking authority and affirm.
     
    I
    The Federal Meat Inspection Act authorizes the Secretary of Agriculture to “prescribe the rules and regulations of sanitation” covering
    slaughtering, meat canning, salting, packing, rendering, or similar establishments in which cattle, sheep, swine, goats, horses, mules and other equines are slaughtered and the meat and meat food products thereof are prepared for commerce....1
    Further, the Secretary is commanded to,
    where the sanitary conditions of any such establishment are such that the meat or meat food products are rendered adulterated, ... refuse to allow said meat or meat food products to be labeled, marked, stamped, or tagged as “inspected and passed.”2
    In sum, the FMIA instructs the Secretary to ensure that no adulterated meat products pass USDA inspection, which they must in order to be legally sold to consumers.3
    The FMIA contains several definitions of “adulterated,” including 21 U.S.C. § 601(m)(4), which classifies a meat product as adulterated 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.”4 Thus, the FMIA gives the Secretary the power to create sanitation regulations and commands him to withhold meat approval where the meat is processed under insanitary conditions. The Secretary has delegated the authority under the FMIA to the Food Safety and Inspection Service.
     
    In 1996, FSIS, after informal notice and comment rulemaking, adopted regulations *435 requiring all meat and poultry establishments to adopt preventative controls to assure product safety. These are known as Pathogen Reduction, Hazard Analysis and Critical Control Point Systems or “HACCP.”5 HACCP requires, inter alia, that meat and poultry establishments institute a hazard control plan for reducing and controlling harmful bacteria on raw meat and poultry products. In order to enforce HACCP, FSIS performs tests for the presence of Salmonella in a plant's finished meat products.
     
    The Salmonella performance standards set out a regime under which inspection services will be denied to an establishment if it fails to meet the standard on three consecutive series of tests.6 The regulations declare that the third failure of the performance standard “constitutes failure to maintain sanitary conditions and failure to maintain an adequate HACCP plan ... for that product, and will cause FSIS to suspend inspection services.”7 The performance standard, or “passing mark,” is determined based on FSIS's “calculation of the national prevalence of Salmonella on the indicated raw product.”8
     
    In June, 1998, plaintiff-appellee Supreme Beef Processors, Inc., a meat processor and grinder, implemented an HACCP pathogen control plan, and on November 2, 1998, FSIS began its evaluation of that plan by testing Supreme's finished product for Salmonella. After four weeks of testing, FSIS notified Supreme that it would likely fail the Salmonella tests. Pursuant to the final test results, which found 47 percent of the samples taken from Supreme contaminated withSalmonella,9 FSIS issued a Noncompliance Report, advising Supreme that it had not met the performance standard. Included in the report was FSIS's warning to Supreme to take “immediate action to meet the performance standards.” Supreme responded to FSIS's directive on March 5, 1999, summarizing the measures it had taken to meet the performance standard and requesting that the second round of testing be postponed until mid-April to afford the company sufficient time to evaluate its laboratory data. FSIS agreed to the request and began its second round of tests on April 12, 1999.
     
    On June 2, 1999, FSIS again informed Supreme that it would likely fail the Salmonella tests and, on July 20, issued another Noncompliance Report—this time informing Supreme that 20.8 percent of its samples had tested positive for Salmonella. Supreme appealed the Noncompliance Report, citing differences between the results obtained by FSIS and Supreme's own tests conducted on “companion parallel samples.” Those private tests, Supreme asserted, had produced only a 7.5 percent Salmonella infection level, satisfying the performance standard. FSIS denied the appeal; but based on Supreme's commitment to install 180 degree water source on all boning and trimming lines, granted the company's request to postpone the next round of Salmonella testing for 60 days. FSIS later withdrew the extension, however, after learning that Supreme was merely considering installation of the water source.
    The third set of tests began on August 27, 1999, and after only five weeks, FSIS advised Supreme that it would again fall short of the ground beef performance standard. *436 On October 19, 1999, FSIS issued a Notice of Intended Enforcement Action, which notified Supreme of the agency's intention to suspend inspection activities. The Notice gave Supreme Beef until October 25, 1999 to demonstrate that its HACCP pathogen controls were adequate or to show that it had achieved regulatory compliance. Although Supreme Beef promised to achieve the 7.5 percent performance standard in 180 days, it failed to provide any specific information explaining how it would accomplish that goal, and FSIS decided to suspend inspection of Supreme's plant.
     
    On the day FSIS planned to withdraw its inspectors, Supreme brought this suit against FSIS's parent agency, the USDA, alleging that in creating the Salmonella tests, FSIS had overstepped the authority given to it by the FMIA. Along with its complaint, Supreme moved to temporarily restrain the USDA from withdrawing its inspectors. The district court granted Supreme's motion and, after a subsequent hearing, also granted Supreme's motion for a preliminary injunction.
     
    The National Meat Association filed a motion to intervene as a plaintiff in the district court. The district court denied the motion on the grounds that NMA was adequately represented by Supreme in this litigation. The district court allowed NMA and other industry groups, as well as various consumer advocacy groups, to file briefs.
     
    On cross-motions for summary judgment, the district court granted summary judgment in favor of Supreme, finding that the Salmonella performance standard exceeded the USDA's statutory authority and entering a permanent injunction against enforcement of that standard against Supreme. The USDA now appeals.
     
    II
    We first must address the USDA's suggestion of mootness. In September, 2000, during the pendency of this appeal, Supreme filed for Chapter 11 bankruptcy. The USDA moved to lift the stay on the appeal and filed a suggestion of mootness with this Court. Supreme argued that it intended to resume operations after reorganization and that the injunction against enforcement of the Salmonella performance standard was critical to that reorganization. A motions panel of this Court denied the motion to remand the case with instructions to dismiss as moot on January 2, 2000. On May 9, 2001, the Bankruptcy Court converted Supreme's case into a Chapter 7 liquidation.
     
    The USDA has again raised the question of mootness. While we are not bound by the earlier determination of the motions panel, which in any event was made while Supreme was still in Chapter 11, rather than Chapter 7, proceedings,10 Supreme asserts that it has substantial assets and could emerge solvent from the Chapter 7 liquidation proceeding. “In general a matter is moot for Article III purposes if the issues presented are no longer live or the parties lack a legally cognizable interest in the outcome.”11 The possibility that Supreme may continue to function as a meat processor even after *437 its Chapter 7 proceeding satisfies Article III.12
     
    The USDA argues that this case is moot because even if Supreme reopens “it is conceivable that it will not open at the same establishment where the violations of the Salmonella standard occurred and will not use the same suppliers.” However, the district court's order is not specific to Supreme's place of business nor its suppliers. The Amended Final Judgment provides in part:
    1. 9 C.F.R. 310.25(b) is hereby declared to be outside the statutory authority of the United States Secretary of Agriculture (the “Secretary”) and the United States Department of Agriculture (the “USDA”)....
    This injunction issued because the district court determined that the USDA was without statutory authority to promulgate the Salmonella performance standards—it cannot be logically restricted to a particular facility.
     
    Furthermore, NMA, having submitted a brief as an amicus curiae supporter of Supreme, again moved to intervene as an appellee, arguing that were we to find that the case was moot with respect to Supreme, NMA's interests were no longer adequately represented by Supreme and this inadequacy only arose during the pendency of the appeal.
     
    We granted NMA's motion to intervene. “A party is entitled to an intervention of right if (1) the motion to intervene is timely; (2) the potential intervener asserts an interest that is related to the property or transaction that forms the basis of the controversy in the case into which [it] seeks to intervene; (3) the disposition of that case may impair or impede the potential intervener's ability to protect [its] interest; and (4) the existing parties do not adequately represent the potential intervener's interest.”13 The district court denied NMA's motion to intervene because it found that NMA's interests were adequately represented by Supreme. In all other respects, NMA satisfies the requirements of intervention as of right under Rule 24(a),14 and we address only adequacy of representation here.
     
    We recognize that while Supreme retains a legally cognizable interest in the outcome of this case, this is because of the possibility that Supreme will emerge from bankruptcy as an entity wishing to carry out meat processing operations. It is also possible, we understand, that Supreme will not so emerge from bankruptcy and be dissolved, perhaps during the pendency of any petition for panel rehearing, rehearing en banc, or writ of certiorari before the U.S. Supreme Court. NMA need only show that Supreme's representation *438 “may be” inadequate,15 and we find the possibility that the case could be mooted by decisions made in Supreme's Chapter 7 proceeding sufficient to satisfy this requirement of Rule 24(a). Were Supreme to cease to exist as a legal entity, or were the case to otherwise become moot with respect to Supreme, NMA would be put in the position of having to re-litigate identical issues on which Supreme was successful in the district court. The interest in avoiding piecemeal litigation is thus served by allowing NMA's intervention.16
     
    Having concluded that this case is not moot, we now turn to the question of whether the Salmonella performance standard represents a valid exercise of rulemaking authority under the FMIA.
     
    III
    Our analysis in this case is governed by the approach first enunciated by the Supreme Court in Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc.17 The Chevron inquiry proceeds in two steps. First, the court should look to the plain language of the statute and determine whether the agency construction conflicts with the text.18 Then, “[i]f the agency interpretation is not in conflict with the plain language of the statute, deference is due.”19 The district court held the Salmonella performance standard invalid as exceeding the statutory authority of the USDA under the first step of the Chevron inquiry.
     
    A
    Following Chevron, we first repair to the text of the statute that the USDA relies upon for its authority to impose the Salmonella performance standard. The USDA directs us to 21 U.S.C. § 601(m)(4), which provides that a meat product is adulterated
    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.
    This statutory definition is broader than that provided in 21 U.S.C. § 601(m)(1), which provides that a meat product is adulterated
    if it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance, such article shall not be considered adulterated under this clause if the quantity of such substance in or on such article does not ordinarily render it injurious to health.
    Thus if a meat product is “prepared, packed or held under insanitary conditions” such that it may be adulterated for purposes of § 601(m)(1), then it is, by definition, adulterated for purposes of § 601(m)(4). The USDA is then commanded to refuse to stamp the meat products “inspected and passed.”20
     
    The difficulty in this case arises, in part, because Salmonella, present in a substantial proportion of meat and poultry *439 products, is not an adulterant per se,21 meaning its presence does not require the USDA to refuse to stamp such meat “inspected and passed.”22 This is because normal cooking practices for meat and poultry destroy the Salmonellaorganism,23 and therefore the presence of Salmonella in meat products does not render them “injurious to health”24 for purposes of § 601(m)(1). Salmonella-infected beef is thus routinely labeled “inspected and passed” by USDA inspectors and is legal to sell to the consumer.
     
    Supreme maintains that since Salmonella-infected meat is not adulterated under § 601(m)(1), the presence or absence of Salmonella in a plant cannot, by definition, be “insanitary conditions” such that the product “may have been rendered injurious to health,” as required by § 601(m)(4). The USDA, however, argues that Salmonella 's status as a non-adulterant is not relevant to its power to regulate Salmonella levels in end product. This is because the USDA believes that Salmonella levels can be a proxy for the presence or absence of means of pathogen25 controls that are required for sanitary conditions under § 601(m)(4). However, as we discuss, and as the USDA admits, the Salmonella performance standard, whether or not it acts as a proxy, regulates more than just the presence of pathogen controls.
     
    The district court agreed with Supreme and reasoned that “[b]ecause the USDA's performance standards and Salmonellatests do not necessarily evaluate the conditions of a meat processor's establishment, they cannot serve as the basis for finding a plant's meat adulterated under § 601(m)(4).”26 The district court therefore held that the examination of a plant's end product is distinct from “conditions” within the plant for purposes of § 601(m)(4) because Salmonella may have come in with the raw material.
     
    We must decide two issues in order to determine whether the Salmonella performance standard is authorized rulemaking under the FMIA: a) whether the statute allows the USDA to regulate characteristics of raw materials that are “prepared, packed or held” at the plant, such as Salmonella infection; and b) whether § 601(m)(4)'s “insanitary conditions” such that product “may have been rendered injurious to health” includes the presence of Salmonella-infected beef in a plant or the increased likelihood of cross-contamination with Salmonella that results from grinding such infected beef. Since we are persuaded that the Salmonella performance standard improperly regulates the *440 Salmonella levels of incoming meat and that Salmonella cross-contamination cannot be an insanitary condition such that product may be rendered “injurious to health,” we conclude that the Salmonella performance standard falls outside of the ambit of § 601(m)(4).
     
    B
    1
    In order for a product to be adulterated under § 601(m)(4), as the USDA relies on it here,27 it must be “prepared, packed or held under insanitary conditions ... whereby it may have been rendered injurious to health.”28 The use of the word “rendered” in the statute indicates that a deleterious change in the product must occur while it is being “prepared, packed or held” owing to insanitary conditions. Thus, a characteristic of the raw materials that exists before the product is “prepared, packed or held”29 in the grinder's establishment cannot be regulated by the USDA under § 601(m)(4).30 The USDA's interpretation ignores the plain language of the statute, which includes the word “rendered.” Were we to adopt this interpretation, we would be ignoring the Court's repeated admonition that, when interpreting a statute, we are to “give effect, if possible, to every clause and word of a statute.”31
    9The USDA claims, however, that the Salmonella performance standard serves as a proxy for the presence or absence of pathogen controls, such that a high level of Salmonella indicates § 601(m)(4) adulteration.32 Supreme oversimplifies *441 its argument by claiming, essentially, that the USDA can never use testing of final product for a non-adulterant, such as Salmonella, as a proxy for conditions within a plant.
     
    We find a similar, but distinct, defect in the Salmonella performance standard. The USDA admits that the Salmonellaperformance standard provides evidence of: (1) whether or not the grinder has adequate pathogen controls; and (2) whether or not the grinder uses raw materials that are disproportionately infected with Salmonella. Supreme has, at all points in this litigation, argued that it failed the performance standard not because of any condition of its facility, but because it purchased beef “trimmings” that had higher levels of Salmonella than other cuts of meat. The USDA has not disputed this argument, and has merely argued that this explanation does not exonerate Supreme, because the Salmonella levels of incoming meat are fairly regulated under § 601(m)(4).33 Our textual analysis of § 601(m)(4) shows that it cannot be used to regulate characteristics of the raw materials that exist before the meat product is “prepared, packed or held.” Thus, the regulation fails, but not because it measures Salmonella levels and Salmonella is a non-adulterant. The performance standard is invalid because it regulates the procurement of raw materials.
     
    2
    Our determination here is not in tension with the Second Circuit's decision interpreting identical language under the Food, Drug, and Cosmetic Act in United States v. Nova Scotia Food Products Corp.34 In Nova Scotia the defendant challenged an FDA regulation requiring the heating of smoked fish to combat the toxin formation of Clostridium botulinum spores, which cause botulism. The defendant argued that “the prohibition against ‘insanitary conditions' embraces conditions only in the plant itself, but does not include conditions which merely inhibit the growth of organisms already in the food when it enters the plant in its raw state.”35 The court gave “insanitary conditions” a broad reading and upheld the regulation.36 Nevertheless, it conceded that “a plausible argument can, indeed, be made that the references are to insanitary conditions in the plant itself, such as the presence of rodents or insects....”37
     
    While this may appear to conflict with our determination that pre-existing characteristics of raw materials before they are “prepared, packed or held” are not within *442 the regulatory reach of § 601(m)(4), the regulations at issue in Nova Scotia did not attempt to control the levels of Clostridium botulinum spores in incoming fish, as the performance standard does to Salmonella in incoming raw meat. Instead, the regulations in Nova Scotia required the use of certain heating and salination procedures to inhibit growth of the spores.38
     
    Nova Scotia did not consider the argument before us today, which is that the statute does not authorize regulation of the levels of bacterial infection in incoming raw materials. The argument that Nova Scotia entertained was that “Congress did not mean to go so far as to require sterilization sufficient to kill bacteria that may be in the food itself rather than bacteria which accreted in the factory through the use of insanitary equipment.”39 The required sterilization under the regulations at issue in Nova Scotia obviously occurred within the plant and did not regulate the quality of incoming fish.
     
    3
    The USDA and its amicus supporters argue that there is no real distinction between contamination that arrives in raw materials and contamination that arises from other conditions of the plant. This is because Salmonella can be transferred from infected meat to non-infected meat through the grinding process. The Salmonella performance standard, however, does not purport to measure the differential between incoming and outgoing meat products in terms of the Salmonellainfection rate. Rather, it measures final meat product for Salmonella infection. Thus, the performance standard, of itself, cannot serve as a proxy for cross-contamination because there is no determination of the incoming Salmonella baseline.
    Moreover, the USDA has not asserted that there is any correlation between the presence of Salmonella and the presenceof § 601(m)(1) adulterant pathogens. The rationale offered by the USDA for the Salmonella performance standard—that “intervention strategies aimed at reducing fecal contamination and other sources of Salmonella on raw product should be effective against other pathogens”40—does not imply that the presence of Salmonella indicates the presence of these other, presumably § 601(m)(1) adulterant, pathogens.41 Cross-contamination of Salmonella alone cannot form the basis of a determination that a plant's products are *443 § 601(m)(4) adulterated, because Salmonella itself does not render a product “injurious to health” for purposes of both §§ 601(m)(1) and 601(m)(4).
     
    Not once does the USDA assert that Salmonella infection indicates infection with § 601(m)(1) adulterant pathogens.42Instead, the USDA argues that the Salmonella infection rate of meat product correlates with the use of pathogen control mechanisms and the quality of the incoming raw materials. The former is within the reach of § 601(m)(4), the latter is not.
     
    IV
    Because we find that the Salmonella performance standard conflicts with the plain language of 21 U.S.C. § 601(m)(4), we need not reach Supreme's numerous alternative arguments for invalidating the standard, which were not addressed by the district court.
     
    V
    We AFFIRM and REMAND with instructions that the final judgment of the district court be amended to include the National Meat Association.
    2
    Notes
    Id.
    The FMIA requires that adulterated meat products be stamped “inspected and condemned” and destroyed. 21 U.S.C. § 606.
    9 C.F.R. Pt. 417.
    Id. § 310.25(b).
    Id. § 310.25(b)(3)(iii).
    Id. § 310.25(b)(2) tbl. 2 n.a.
    The performance standard for raw ground beef is 7.5 percent. Id.
    AT&T Communications of the Southwest, Inc. v. City of Dallas, 243 F.3d 928, 930 (5th Cir.2001) (stating that although a motions panel had denied a motion to vacate as moot, court could consider arguments on appeal and “overturn [the motions panel] where necessary.” (quoting Mattern v. Eastman Kodak, Co., 104 F.3d 702, 704 (5th Cir.1997))).
    Since we find that Article III is satisfied by Supreme's continuing legally cognizable interest in the outcome, we need not address its argument that this case falls into that category of disputes capable of repetition yet evading review.
    Fed.R.Civ.P. 24(a). There can be no serious dispute that NMA's original motion to intervene was timely and that NMA has an interest in this lawsuit, given that it deals with the application of a performance standard that affects NMA's members. NMA has standing to pursue this appeal. “An association has standing to bring a suit on behalf of its members when: (1) its members would otherwise have standing to sue in their own right; (2) the interests it seeks to protect are germane to the organization's purpose; and (3) neither the claim asserted nor the relief requested requires the participation of individual members.” Central and South West Services, Inc. v. EPA, 220 F.3d 683, 698 (5th Cir.2000).
    See, e.g., Goodman v. Heublein, 682 F.2d 44, 47 (2d Cir.1982) (granting motion to intervene in part to avoid piecemeal litigation).
    Id.
    See American Pub. Health Ass'n v. Butz, 511 F.2d 331, 334 (D.C.Cir.1974) (“[T]he presence of salmonellae on meat does not constitute adulteration within this definition [of ‘adulterated,’ provided in 21 U.S.C. § 601(m)].”). The USDA agrees in this case that Salmonella is not an adulterant per se, meaning it is not a § 601(m)(1) adulterant. Appellant's Brief at 11.
    Butz, 511 F.2d at 334 (“American housewives and cooks normally are not ignorant or stupid and their methods of preparing and cooking of food do not ordinarily result in salmonellosis.”).
    Cf. Continental Seafoods, Inc. v. Schweiker, 674 F.2d 38, 41 (D.C.Cir.1982) (stating that Salmonella is a per se adulterant in shrimp).
    The USDA uses the term “pathogen” to refer to both § 601(m)(1) adulterants, such as pathogenic E.coli, and non-adulterants, such as Salmonella. Thus, under the proxy theory, Salmonella control correlates with adulterant-pathogen control.
    The USDA does not contend that failure of the Salmonella performance standard serves as a proxy for contamination with filth, the other prong dealt with by § 601(m)(4). Even if the USDA made such an assertion, § 601(m)(4) speaks of insanitary conditions such that a product “becomes” contaminated with filth, which has a similar textual meaning as “rendered.”
    21 U.S.C. § 601(m)(4) (emphasis added).
    This case does not require us to define precisely when a product begins the process of being “prepared, packed or held.” We recognize only that this process cannot begin until the raw materials are brought to the plant. Thus, the condition of the raw materials may not be regulated by § 601(m)(4).
    However, measures that would alter such a characteristic, such as heating fish to destroy the bacteria that causes botulism, are within the scope of § 601(m)(4). See Part III.B.2.
    We note that the USDA's assertions on this point are suspect. It is clear that the motivation behind the Salmonella performance standard was the regulation of Salmonella itself, and the FSIS has admitted as much in the Final Rule, though this admission is absent from the USDA's briefs in this case. See Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) Systems; Final Rule, 61 Fed.Reg. 38806, 38850(“Because testing for E. coli cannot serve as a surrogate for the presence of Salmonella, FSIS's specific public health objective of reducing nationwide Salmonella levels on raw meat and poultry products, including raw ground products, requires a standard and testing regime that are directed at that pathogen.” (emphasis added)). The difficulty with this, of course, is that the USDA has no statutory authority to regulate the levels of non-adulterant pathogens.
    While we do not question the agency's expertise, we also note that several equivocal statements about the effectiveness of Salmonella levels as a proxy for pathogen controls appear in the Final Rule. See Id. at 38835 (“And, interventions targeted at reducing Salmonella may be beneficial in reducing contamination by other enteric pathogens.” (emphasis added)); Id. at 38846 (“[I]ntervention strategies aimed at reducing fecal contamination and other sources of Salmonella on raw product should be effective against other pathogens.”).
    The USDA repeatedly asserts that it has the power to regulate the Salmonella levels of incoming raw materials used in grinding establishments. See, e.g., Appellant's Reply Brief at 12 (“To operate in a sanitary manner, a plant must match the level of its pathogen controls to the nature of the meat it purchases. The greater the risk of contamination in the incoming product, the greater the need for strategies to reduce microbial contamination.”); 61 Fed.Reg. at 38846 (“Establishments producing raw ground product from raw meat or poultry supplied by other establishments cannot use technologies for reducing pathogens that are designed for use on the surfaces of whole carcasses at the time of slaughter. Such establishments may require more control over incoming raw product, including contractual specifications to ensure that they begin their process with product that meets the standard .... ”) (emphasis added).
    Id. at 246 (“When agency rulemaking serves the purposes of the statute, courts should refuse to adopt a narrow construction of the enabling legislation which would undercut the agency's authority to promulgate such rules.”).
    Id. at 243 (describing time-temperature-salinity regulations for hot-process smoked fish). This is consistent with the entirety of cases dealing with this statute, none of which concern “conditions” extrinsic to the place where the products are “prepared, packed or held.” See, e.g., United States v. Gel Spice Co., Inc., 773 F.2d 427, 430 (2d Cir.1985) (rodent infestation in plant); United States v. King's Trading, Inc., 724 F.2d 631, 632 (8th Cir.1983) (rodent infestation in warehouse); United States v. 1,638 Cases of Adulterated Alcoholic Beverages and Other Articles of Food, 624 F.2d 900, 901–02 (9th Cir.1980) (flooding in storage area); United States v. Certified Grocers Co-op., 546 F.2d 1308, 1310–11 (7th Cir.1976) (rodent infestation in warehouse). Even the USDA does not argue that § 601(m)(4) reaches “conditions” external to the establishment, but rather that control of pathogen levels in incoming raw materials are necessary to maintain sanitary conditions inside of the establishment. See Appellant's Brief at 38–39.
    Id. at 246.
    One might speculate that such a conclusion would create problems for the USDA, because a statement that Salmonella was a proxy for, for example, pathogenic E. coli could arguably require the determination that the presence of Salmonella rendered a product § 601(m)(1) adulterated. This would prevent Salmonella-infected meat from being sold in the United States to consumers.
    The amicus curiae consumer groups in their brief appear not to recognize the distinction between a correlation between Salmonella and other enteric pathogens in raw materials and a correlation between reductions in Salmonella and reductions in other enteric pathogens when the same control methods are used. See Brief of Amicus Curiae Consumer Groups at 10–11.
  • 4 Food & Water Watch, Inc v. Vilsack, 808 F.3d 905 (D.C. Cir. 2015)

    Notes: <p>1. <span class="caps">FSIS</span>, <span class="caps">PPIA</span>, and <span class="caps">NPIS</span>. As the opinion discusses in some detail, <span class="caps">FSIS</span> administers the <span class="caps">PPIA</span>. Historically, <span class="caps">FSIS</span> inspected poultry using four systems. Offline inspectors ensure compliance with food safety regulations, verify sanitation procedures, and collect samples for testing. Online inspectors inspect the actual poultry. At issue in the case was the New Poultry Inspection System (<span class="caps">NPIS</span>), which shifted from inspector-based sorting and evaluation to establishment-based sorting and evaluation. That is, <span class="caps">NPIS</span> relocates inspection responsibilities to firms rather than government personnel.</p> <p>2. Food Safety Harms. The plaintiffs in Food &amp; Water Watch alleged that the new inspection procedures would increase the risk of food borne illness and therefore sought to stop the program. To satisfy the constitutional requirements for standing in Article <span class="caps">III</span>, plaintiffs must show injury-in-fact. Directly regulated parties typically have no trouble satisfying this requirement because a given federal regulation requires them to take an action or suffer penalties. Poultry facilities would have no difficulty demonstrating standing. For third parties&#8212;individuals not directly regulated by the Rule, showing that they are or are likely to be harmed by the rule is far more difficult. Note that in practice this may mean rules deemed undesirable by regulated parties will be litigated, but rules deemed desirable by regulated parties are less likely to be litigated.</p>
    1

    Food & Water Watch, Inc. v. Vilsack, 808 F.3d 905 (D.C. Cir. 2015)

    2

    Before: HENDERSON, MILLETT and WILKINS, Circuit Judges. (foornotes omitted) 

    3

    WILKINS, Circuit Judge:

    4

    Margaret Sowerwine and Jane Foran, individual consumers of poultry, and Food & Water Watch, Inc. (“FWW”), their organizational advocate, fear that new regulations promulgated by the United States Department of Agriculture (“USDA”) may result in an increase in foodborne illness from contaminated poultry. To prevent the regulations from going into effect, Plaintiffs sought declaratory and injunctive relief. The District Court concluded that Plaintiffs failed to demonstrate an injury in fact and dismissed Plaintiffs’ claims for lack of standing.

    5

     * * *

    6

    I.

    7

    The Poultry Products Inspection Act (“PPIA”), 21 U.S.C. §§ 451472, was born out of a Congressional interest in protecting consumer health and welfare by enabling the Secretary of Agriculture (“Secretary”) to ensure that poultry products were “wholesome, not adulterated, and properly marked, labeled, and packaged.” 21 U.S.C. § 451. The PPIA accomplishes this goal, in part, by requiring the Secretary **371 *910 to ensure that inspectors1 conduct a post-mortem inspection of all poultry processed for human consumption. Id. § 455(b). The PPIA also requires condemnation and destruction for human food purposes of all poultry that is found to be adulterated, unless the poultry can be reprocessed under an inspector’s supervision so that it is found to be not adulterated. Id. § 455(c). The PPIA defines “adulterated” to include various conditions, including containing, among other things, “any poisonous or deleterious substance which may render it injurious to health”; various additives that are unfit for human consumption; consisting in whole or in part of any “filthy, putrid, or decomposed substance or is for any other reason unsound, unhealthful, unwholesome, or otherwise unfit for human food”; or packaging in conditions where it “may have been rendered injurious to health.” Id. § 453(g). Carcasses that pass inspection receive an official legend indicating that it was inspected by the USDA. Id. § 453(h)(12); 9 C.F.R. § 381.96.

    8

    The Food Safety and Inspection Service (“FSIS”) administers the PPIA. See 7 C.F.R. §§ 2.18(a)(1)(ii)(A), 2.53(a)(2)(i). Historically, FSIS has permitted chicken and turkey—the poultry products of concern to Plaintiffs—to be inspected under one of four inspection systems: the Streamlined Inspection System, the New Line Speed Inspection System, the New Turkey Inspection System, and traditional inspection (collectively, “the existing inspection systems”). Modernization of Poultry Slaughter Inspection, 77 Fed.Reg. 4408, 4410 (proposed Jan. 27, 2012). Under the existing inspection systems, FSIS inspectors perform either an online or offline role. See id. Offline inspectors ensure compliance with food safety regulations, verify sanitation procedures, and collect samples for pathogen testing. See id. One or more online FSIS inspectors inspect each poultry carcass with its viscera2 immediately following the separation of the viscera from the carcass. See id. Under the existing inspection systems, the inspectors conduct an “organoleptic” inspection, using sight, touch, and smell to evaluate the carcasses. See Brief for Appellees, Food & Water Watch, Inc. v. Vilsack, No. 15–5037 (D.C. Cir.), Doc. No. 1553589, at 3; see also 77 Fed.Reg. at 4410 (noting that inspectors “examine each eviscerated carcass for visual defects”). Poultry establishment personnel do not conduct any sorting or evaluation of carcasses; the poultry establishments provide a “helper” who takes action only upon an FSIS inspector’s direction. 77 Fed.Reg. at 4410.

    9

    The inspection method at issue in this case, the New Poultry Inspection System (“NPIS”), alters the responsibilities of the FSIS inspectors and the establishment personnel. The NPIS rules institutionalize the shift from inspector-based sorting and evaluation to establishment-based sorting and evaluation. Under the NPIS, poultry establishment personnel sort the poultry carcasses and take corrective action prior to an FSIS inspection. See id. at 4421.

    10

    *911 **372 The NPIS grew out of FSIS’s concern that agency resources were not being used in the most effective way to ensure food safety. See id. at 4410. In an effort to develop new methods to more effectively inspect poultry, in 1996 FSIS promulgated the “Pathogen Reduction/Hazard Analysis and Critical Control Points” (“HACCP”) rule. Id. at 4413; Pathogen Reduction; Hazard Analysis and Critical Control Points, 61 Fed.Reg. 38806 (July 25, 1996). HACCP required poultry establishments to develop controls to ensure product safety and empowered the establishments to make their own determinations about how to meet the FSIS regulatory requirements. 77 Fed.Reg. at 4413. FSIS subsequently announced an HACCP-based inspection models project (“HIMP”) that would allow FSIS to test and develop new inspection models. HACCP–Based Meat and Poultry Inspection Concepts, 62 Fed.Reg. 31553 (June 10, 1997). The pilot HIMP method made poultry establishment personnel “responsible for identifying and removing normal from abnormal carcasses and parts.” 77 Fed.Reg. at 4413.

    11

    The HIMP pilot was challenged as a violation of the PPIA because FSIS inspectors did not inspect poultry carcasses themselves, leaving all inspection to establishment personnel with FSIS oversight. Am. Fed’n of Gov’t Empls., AFL–CIO v. Glickman (AFGE I ), 215 F.3d 7, 9–10 (D.C.Cir.2000). This Court held that such delegation violated the PPIA. Id. at 11. In response to AFGE I, “FSIS modified HIMP to position one inspector at a fixed location near the end of the slaughter line in each poultry slaughter establishment” who was responsible for evaluating each carcass after establishment personnel had sorted and processed it. 77 Fed.Reg. at 4413. The modified HIMP program was also challenged, and this Court held that the program did not violate the PPIA. Am. Fed’n of Gov’t Empls., AFL–CIO v. Veneman, 284 F.3d 125, 130–31 (D.C.Cir.2002). However, we cautioned that “[i]f the USDA undertakes a rulemaking to adopt as a permanent change something along the lines of the modified program, experience with the program’s operation and its effectiveness will doubtless play a significant role” and warned that our opinion “may not necessarily foreshadow the outcome of judicial review of such future regulations.” Id. at 130–31.

    12

    Twenty young chicken and five turkey establishments participated in HIMP, and FSIS collected and analyzed the data from these establishments. 77 Fed.Reg. at 4414. Using this data, FSIS concluded that the HIMP procedures “improved performance related to food safety and non-food-safety standards ... especially in reducing pathogen levels” and proposed the NPIS to replace the existing inspection systems, excluding the traditional inspection system. Id. at 4421. Under the proposed NPIS rule, “establishments [would] be required to sort carcasses, to dispose of carcasses that must be condemned, and to conduct any necessary trimming or reprocessing activities before carcasses are presented to the online FSIS carcass inspector.” Id. The carcasses would pass along a production line for the online inspector at a speed of 175 birds per minute for young chickens, and 55 birds per minute for turkeys. Id. at 4423. While establishment personnel sort carcasses, FSIS inspectors would reallocate their time by increasing offline inspection activities. Id. at 4420, 4422. FSIS projected that 99.9% of young chickens and poultry would be produced under the NPIS. Id. at 4436. After a notice and comment period, FSIS adopted a final NPIS rule with a number of modifications, which included making adoption of the NPIS optional, and lowering the birds per minute speed of young chickens to 140 birds per minute. **373 *912 Modernization of Poultry Slaughter Inspection, 79 Fed.Reg. 49566, 49570 (Aug. 21, 2014)

    13

    On September 11, 2014, Plaintiffs filed their complaint in this case, claiming that the NPIS constitutes “an unprecedented elimination of inspection resources for a secret set of young chicken and turkey slaughterhouses.” Compl. ¶ 1, J.A. 9. In this spirit, Plaintiffs alleged eight claims against Defendants: (1) violation of 21 U.S.C. § 455(c) by allowing condemnation of young chicken and turkey carcasses by NPIS establishment personnel; (2) violation of 21 U.S.C. § 455(c) by allowing reprocessing of young chickens and turkeys by NPIS establishment personnel without inspector supervision; (3) violation of 21 U.S.C. § 455(b) because each young chicken and turkey carcass will not receive a post-mortem inspection in NPIS establishments; (4) violation of the PPIA’s branding requirements; (5) violation of 21 U.S.C. § 455(b) and 9 C.F.R. § 381.1 because each chicken and turkey viscera will not be federally inspected; (6) violation of 21 U.S.C. § 463(c) for failure to provide an opportunity for oral presentation of views; (7) violation of the Administrative Procedure Act (“APA”) by failing to provide adequate opportunity for notice and comment; and (8) violation of the APA because the final NPIS rules are arbitrary and capricious. Plaintiffs sought declaratory and injunctive relief. On the same day they filed the complaint, Plaintiffs moved for a preliminary injunction on Claims 1, 2, 6, and 7. The District Court heard the motion on October 17, 2014.

    14

    On February 9, 2015, the District Court dismissed the case for lack of subject matter jurisdiction because Plaintiffs lacked standing, and denied the motion for preliminary injunction and all other pending motions as moot. Food & Water Watch, Inc. v. Vilsack, 79 F.Supp.3d 174, 206 (D.D.C.2015). With respect to the Individual Plaintiffs, the District Court found that they did not suffer an injury in fact in order to establish standing. Id. at 190–95. The District Court also found that FWW lacked standing as an organization, and that Plaintiffs did not suffer a procedural injury sufficient to establish standing. Id. at 199–206. Plaintiffs appeal the dismissal on these grounds.

    15

    * * *

    16

     III.

    17

    Plaintiffs first contend that the Individual Plaintiffs, Sowerwine and Foran, have alleged an injury in fact. Plaintiffs also submit that FWW would have associational standing on behalf of its members. See, e.g., Sierra Club v. EPA, 754 F.3d 995, 999 (D.C.Cir.2014) (explaining that associational standing requires an organization to show, among other things, that “at least one of [the organization’s] members would have standing to sue”). Because the analyses for both the Individual Plaintiffs and FWW’s members are identical, see id., we address them jointly here.

    18

    For the Individual Plaintiffs or FWW’s individual members to establish standing, they must show (i) they have “suffered a concrete and particularized injury in fact, (ii) that was caused by or is fairly traceable to the actions of the defendant, and (iii) is capable of resolution and likely to be redressed by judicial decision.” Osborn v. Visa, 797 F.3d 1057, 1063 (D.C.Cir.2015) (internal quotation marks omitted). Here, because Plaintiffs are not directly subjected to the regulation they challenge, “standing is ‘substantially more difficult to establish.’ ” Public Citizen, Inc. v. Nat’l Highway Traffic Safety Admin. (Public Citizen I ), 489 F.3d 1279, 1289 (D.C.Cir.2007) (citing Defs. of Wildlife, 504 U.S. at 562, 112 S.Ct. 2130). In order to have suffered an injury in fact, Plaintiffs must have suffered an injury that is “(1) concrete, (2) particularized, and (3) actual or imminent.” Id. at 1292. A concrete injury is “direct, real, and palpable—not abstract.” Id. A particularized injury is “personal, individual, distinct, and differentiated—not generalized or undifferentiated.” Id. An actual or imminent injury is “certainly impending and immediate—not remote, speculative, conjectural, or hypothetical.” Id. at 1293.

    19

    Here, Plaintiffs claim their injury in fact is an increased risk of foodborne illness from unwholesome, adulterated poultry resulting from the Defendants’ regulation.4 Increased-risk-of-harm cases implicate the requirement that an injury be actual or imminent because “[w]ere all purely speculative increased risks deemed injurious, the entire requirement of actual or imminent injury would be rendered moot, because all hypothesized, nonimminent injuries could be dressed up as increased risk of future injury.” Id. at 1294 (quoting NRDC v. EPA (NRDC II ), 464 F.3d 1, 6 (D.C.Cir.2006)) (internal quotation marks omitted). Furthermore, “[t]he Supreme Court has repeatedly held that disputes about future events where the possibility of harm to any given individual is remote and speculative are properly left to the policymaking Branches, not the Article III courts.” Id. at 1295. As a result, this Court has limited its jurisdiction over cases alleging the possibility of increased-risk-of-harm to those where the plaintiff can show “both (i) a substantially increased risk of harm and (ii) a substantial probability of harm with that increase taken into account.” Id. at 1295 (emphasis in original); accord Susan B. Anthony List, 134 S.Ct. at 2341 (“An allegation of future injury may suffice if the threatened injury is ‘certainly impending,’ or there is a “ ‘substantial risk’ ” that the harm will occur.’ ” (quoting Clapper v. Amnesty Int’l USA, ––– U.S. ––––, 133 S.Ct. 1138, 1147 n. 5, 1150, 185 L.Ed.2d 264 (2013))). “The word ‘substantial’ of course poses questions of degree, questions far from fully **376 *915 resolved.” Va. State Corp. Comm’n v. FERC, 468 F.3d 845, 848 (D.C.Cir.2006).

    20

    Although Plaintiffs may establish standing by demonstrating an increased risk of harm, “[i]n applying the ‘substantial’ standard, we are mindful ... that the constitutional requirement of imminence ... necessarily compels a very strict understanding of what increases in risk and overall risk levels can count as ‘substantial.’ ” Public Citizen I, 489 F.3d at 1296. Accordingly, “the proper way to analyze an increased-risk-of-harm claim is to consider the ultimate alleged harm—such as death, physical injury, or property damage ...—as the concrete and particularized injury and then to determine whether the increased risk of such harm makes injury to an individual citizen sufficiently ‘imminent’ for standing purposes.” Id. at 1298.

    21

     

    22

    The Individual Plaintiffs’ and FWW members’ alleged harm is the foodborne illness that would result from consuming adulterated, unwholesome chicken produced under the NPIS. In order to have standing, therefore, Plaintiffs at least need to plausibly allege that the NPIS substantially increases the risk of foodborne illness when compared to the existing inspection methods. Accordingly, in order to satisfy this Court’s two-part analysis, the Plaintiffs must demonstrate, under the relevant standard, (1) that the NPIS substantially increases the risk of contracting foodborne illness compared to the existing inspection methods, and (2) a substantial probability that the Individual Plaintiffs and FWW members will contract a foodborne illness given that increase of risk. A failure to satisfy either of these prongs would deprive this Court of jurisdiction to hear Plaintiffs’ case. See Public Citizen I, 489 F.3d at 1295.

    23

    A.

    24

    Plaintiffs argue that their complaint and submissions in support of their motion for preliminary injunction sufficiently establish that the NPIS substantially increases the risk of harm that will arise from consuming unwholesome, adulterated poultry. Defendants submit that Plaintiffs have failed to demonstrate a substantially increased risk of harm.

    25

    We find that Plaintiffs’ complaint, as well as their various submissions in support of their motion for preliminary injunction, fails to plausibly allege that the NPIS taken as a whole substantially increases the risk of foodborne illness as a result of unwholesome, adulterated poultry. First, a careful examination of Plaintiffs’ allegations demonstrates that they have not plausibly alleged that the NPIS substantially increases the risk of foodborne illness compared to the existing inspection systems. To be sure, Plaintiffs’ submissions contained detailed allegations about how HIMP, and by extension, the NPIS, differs from the existing poultry inspection systems. See Compl. ¶¶ 31–77, J.A. 16–25. The complaint is replete with what Plaintiffs argue are the NPIS’s inadequacies. See Compl. ¶¶ 78–126, J.A. 25–29. The complaint also outlines what Plaintiffs perceive are the flaws with the HIMP studies and analyses. See Compl. ¶¶ 148–61, J.A. 33–35. However, these differences and perceived flaws do not demonstrate a substantial increase in the risk of foodborne illness under the NPIS compared to the existing inspection systems. 

    26

    To the extent that the presence of adulterated, unwholesome poultry could give rise to an inference of resulting foodborne illness, these allegations still fall short because they fail to allege that the NPIS as a whole will produce significantly more adulterated, unwholesome chicken compared to the existing inspection systems. Plaintiffs’ allegations focus on certain discrete aspects of the NPIS: the reduced number of **377 *916 online federal inspectors, the speed at which the online federal inspectors must evaluate carcasses, and the substitution of establishment personnel for federal inspectors. See Compl. ¶¶ 78–121, J.A. 25–29. However, Plaintiffs’ complaint contains only a single allegation that references another key aspect the NPIS: the reallocation of resources for offline inspection. Compl. ¶ 183, J.A. 39. Under the NPIS, additional offline verification inspectors will check to see to that inspection protocols are being followed and conduct pathogen testing. See 77 Fed.Reg. at 4422. Plaintiffs’ complaint makes no allegation regarding the impact of increased offline verification inspectors on the presence of adulterated, unwholesome poultry. Although Plaintiffs fault Defendants for failing to account for a reduction in online inspectors in Defendants’ risk assessment, Plaintiffs’ failure to account for the increase in offline inspections and their attendant impact on poultry production prevents us from inferring that the NPIS as a whole substantially increases the risk of foodborne illness.

    27

    Other allegations in the complaint reveal the same problem. For example, the complaint outlines HIMP personnel’s alleged failure to catch disease-related conditions on poultry. See Compl. ¶ 177, J.A. 38 (“An FWW analysis of the data for 14 HIMP plants found that out of 229 [Noncompliance Reports] filed from March to August 2011, 208 (90 percent) were for visible fecal contamination that was missed by company employees.”). Although these allegations, at best, give rise to the inference that establishment personnel will not be as effective in identifying adulterated poultry, they do not allege how NPIS inspection as a whole will impact the amount of adulterated poultry. Notably, these allegations do not allege that these results are worse than what plants do under existing inspection systems. Thus, they fail to plausibly allege that the regulations substantially increase the risk of foodborne illness.

    28

    Plaintiffs’ submissions in support of their motion for preliminary injunction suffer from the same defect. The sworn affidavits from existing USDA inspectors go into great detail about the differences between the NPIS and existing poultry inspection systems. One inspector explained that under the existing inspection systems, they “would have 3 inspectors on each line, with 90 birds per minute split among them, so that each inspector was looking at 30 birds per minute” but under HIMP, one inspector looks “at up to 200 birds, or more, per minute.” J.A. 298. Another inspector claimed, “I know I cannot detect all of the carcasses with Food Safety defects, and it is reasonable to assume that some are going out to the public.” J.A. 306. A third inspector said, “I know the kinds of unwholesome, mutilated, and diseased chickens that are processed and shipped out for sale and I feel it is important to share this information with consumers and taxpayers” because the HIMP system “is tantamount to having the wolves watch the proverbial henhouse, but these chickens are real and they could very likely hurt or kill someone.” J.A. 317. Another inspector who worked previously for a chicken production company and serves currently as a USDA inspector outlined the various pressures that poultry production personnel are under to increase the number of birds that are shipped out to consumers. J.A. 32124. Although these statements may be alarming, even taken as true, they do not allege that there **378 *917 is a substantially increased risk of foodborne illness because they do not allege that the risk of unwholesome, adulterated poultry is higher under the NPIS as a whole than the existing inspection systems.

    29

    Plaintiffs could perhaps overcome this deficiency by providing the Court with an alternative basis from which to infer that NPIS inspection results in a substantially increased risk of unwholesome, adulterated poultry. Here, if Plaintiffs could plausibly allege through their use of statistics that NPIS poultry creates a substantial increase in the risk of foodborne illness, they would allege a sufficient injury for standing. We have, in the past, refused to require a quantitative analysis in order to establish standing in increased-risk-of-harm cases, see NRDC II, 464 F.3d at 7, and we likewise refuse to hold that statistics are required for such cases. However, we remain mindful that “[d]etermining whether a complaint states a plausible claim [of injury] is context-specific, requiring the reviewing court to draw on its experience and common sense.” Ashcroft v. Iqbal, 556 U.S. 662, 663–64, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009). Accordingly, where a plaintiff’s allegations incorporate statistics and the plaintiff contends that the statistics demonstrate a substantial increase in the risk of harm, the plaintiff must allege something from which the Court can infer that risk. Using our experience and common sense, we cannot make this inference from Plaintiffs’ statistics. 

    30

    A review of Plaintiffs’ statistics demonstrates their failure to plausibly allege a substantial increase in the risk of harm. Plaintiffs point to isolated statistics where Defendants found Salmonella rates to be “higher” in chicken processed in HIMP establishments than in non-HIMP establishments, but the complaint does not specify how much higher the rates were. See Compl. ¶¶ 162–164, J.A. 35–36. Plaintiffs also submitted selections from an FSIS report that found under some scenarios, “a 0.2% increase in the proportion of samples testing Campylobacter positive,” but the same page of this report concluded that under most projected scenarios, the samples testing positive for Salmonella or Campylobacter would decrease. J.A. 430. Plaintiffs also alleged that 0.1% of Campylobacter illnesses would be attributable to the NPIS “under some scenarios.” Compl. ¶ 180, J.A. 39. Plaintiffs likewise relied on Defendants’ risk assessment assumption that annual Salmonella and Campylobacter illness “attribut[able] to poultry are about 174,686 and 169,005, respectively.” J.A. 430. Plaintiffs plucked these statistics from Defendants’ studies but provide no allegations from which we can infer that the statistics reflect a substantial increase in the risk of harm. Indeed, Defendants’ risk assessment concluded under most scenarios that annual illnesses from Salmonella and Campylobacter would remain unchanged or would decrease under the NPIS. J.A. 430–31. Even Plaintiffs’ complaint acknowledges that the risk of Campylobacter increase is “ambiguous.” Compl. ¶ 180, J.A. 39. An ambiguous increase in risk is hardly a substantial increase in risk.

    31

    Plaintiffs’ statistics suffer from additional problems. First, these studies predate the final rule’s amendments. Although not necessarily a problem by itself, the rule’s amendments specifically lowered the line speeds (one of Plaintiffs’ chief criticisms) and made the transition to NPIS inspection voluntary. Plaintiffs make no allegations about the impact of these changes on their statistical claims. Furthermore, Plaintiffs fail to account for how increased allocations in offline inspections would impact the risk. In this context, Plaintiffs’ statistics do not plausibly allege that NPIS inspection as a whole substantially increases the risk that poultry will be contaminated **379 *918 with Salmonella or Campylobacter compared to the existing inspection systems. Because Plaintiffs have failed to plausibly allege that the NPIS substantially increases the risk of producing unwholesome, adulterated poultry compared to the existing inspection systems, they do not have standing. 

    32

    ***

    33

    VI.

    34

    For the foregoing reasons, we hold that Plaintiffs have failed to show any cognizable injury sufficient to establish standing. Accordingly, we affirm the District Court.

    35

    So ordered. 

    36

    (Concurring Opinions of Judge Henderson and Judge Millit omitted)

    37

     

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