Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852
Re: Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Availability; Chapter 11 – Food Allergen Program, Docket No. FDA-2016-D-2343
Dear Sir or Madam:
PepsiCo, Inc. (PepsiCo) appreciates the opportunity to provide comments to the Food and Drug Administration (FDA or agency) regarding Chapter 11 – Food Allergen Programs of the Hazard Analysis and Risk-Based Preventive Controls for Human Food Draft Guidance (Draft Guidance). PepsiCo is a global food and beverage leader with net revenues of more than $91 billion and a product portfolio that includes 23 brands that generate more than $1 billion each in annual retail sales. Our main businesses – Quaker, Gatorade, Frito-Lay and Pepsi- Cola – make hundreds of enjoyable foods and beverages that are loved throughout the world. PepsiCo is dedicated to producing the safest, highest-quality and best-tasting beverages and foods in every part of the world. Developing and maintaining robust food safety programs is how we assure safety for every package, every day in every market. For more information, please visit PepsiCo Product Safety and Quality.
The control of major food allergens is one of the foundational programs in the requirements established by the FDA Food Safety Modernization Act (FSMA) and 21 CFR Part 117. PepsiCo takes its food allergen program extremely seriously and welcomes additional guidance for allergen controls from FDA. Unfortunately, we are all too familiar with the consequences of programs that do not effectively manage allergens. After conducting several recalls and receiving a Warning Letter from FDA for undeclared allergen issues involving select Frito-Lay products, we have scrutinized our systems and have dedicated substantial time and resources to developing robust and systemic allergen control practices. Given our company’s focus on allergens as a food safety issue across the enterprise, we wish to share our comments based on our unique experience and learnings.
First and foremost, we urge FDA not to lose sight of the purpose of risk-based preventive controls. We are concerned that FDA’s Draft Guidance regarding allergen labeling content controls, supplier verification testing, and current Good Manufacturing Practices (GMPs) in particular is overly prescriptive and fails to provide companies with sufficient flexibility to implement allergen controls informed by their procedures, products, facilities, and history. Such a rigid framework is contrary to the spirit of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food Rule, which recognizes the need for flexibility and to implement food safety controls based on food safety risks identified through a hazard analysis. PepsiCo is a member of the Consumer Brands Association (CBA) and The Food Industry Association (FMI) and supports the comments that CBA and FMI submit to this docket. We write separately to reinforce CBA’s and FMI’s comments and to add our perspective on four issues:
The Draft Guidance should offer companies sufficient flexibility to conclude a label content preventive control is not necessary based on a risk-assessment taking into account the company’s procedures and history;
Verification of supplier allergen practices can be based on a systemic supplier approval process and may not include ingredient testing;
The Draft Guidance should be revised to reinforce the flexibility companies have in selecting GMPs and deciding whether to elevate one or more GMPs to a preventive control; and
FDA should recognize food allergen thresholds, such as those established by the Food and Agriculture Organization (FAO) of the United Nations and World Health Organization (WHO)
We address these four topics in the comments that follow.
(1) The Draft Guidance should offer companies sufficient flexibility to conclude a label content preventive control is not necessary based on the company’s operations and history.
We appreciate FDA’s distinction in the Draft Guidance between label “content” and label “management” and their respective roles for controlling for allergens. However, we believe that the Draft Guidance gives label “content” an outsized role in the allergen control process. Our recall history and experience have shown us that label management at the plant-level, i.e., ensuring the correct label is applied to the correct product, is critical to minimizing the potential hazard of undeclared allergens. Following the recalls, we implemented label management preventive controls to minimize the opportunity for human error and create additional layers of protection so that if errors are made, they are identified and remediated before product enters commerce. We therefore support the Draft Guidance’s recognition of automatically generated label monitoring records and selection of the correct label (right label, right product) as an allergen preventive control.
Label content, on the other hand, has not been a source of concern in our allergen program. We manage label content through a robust corporate-level program that ensures the accuracy of the label through a series of checks and balances demonstrating a minimal risk to label content errors. Under PepsiCo’s multi-disciplinary, allergen and ingredient statement review process, the regulatory team creates, reviews, and maintains ingredient and allergen information for all products to ensure accurate and compliant labeling. Our ingredient review process includes collecting allergen information through a supplier questionnaire (addressing both formulation and cross contact), discussions with the supplier to assess cross contact risk, and then regulatory and food safety review of the PepsiCo-developed ingredient specification, which is then subject to supplier sign- off. Our product development review process involves creating the formula specification based on the ingredient specifications, which is reviewed by the food safety team (including an assessment of allergen cross contact risks at our facilities) and is then used to develop the Label Information Document (LID). The LID is reviewed by the regulatory team, food safety team and product development team for accuracy (including for accurate allergen information) before it is sent to the graphics house. The regulatory team then reviews the
2 label proof against the label specification, before authorizing printing. We believe that this corporate team, which has been involved in each step of the label development process and has expertise in allergen labeling, rather than the employees at the plant, is in the best position to verify the label proof against the product specification to ensure accuracy.
These checks and balances are working and would not be further strengthened by managing this process as a preventive control. Creating the additional documentation and recordkeeping required for a preventive control therefore would not be the best use of resources to prevent the occurrence of undeclared allergens in our products. After scrutinizing our history and our systems, we have reached the conclusion that our resources, time, and focus are best spent on managing labels to confirm the correct product ends up in the correct packaging. Our label content systems have demonstrated that they are effective. The Draft Guidance should reflect this reality and offer flexibility to companies to determine if label content preventive controls are appropriate based on risk assessments evaluating their own practices, procedures, facilities, and experience.
(2) Verification of supplier allergen practices can be based on a systemic supplier approval process rather than relying on verification testing.
PepsiCo appreciates the importance of verifying that allergens are properly managed throughout the supply chain. We are concerned, however, that the Draft Guidance over emphasizes the role of ingredient testing and could be interpreted to suggest that ingredient testing is an expected supplier verification activity.1 The Draft Guidance states that companies should conduct product testing for ingredients that include an allergen advisory statement as part of the supplier approval process, including an evaluation of whether to carry forward the advisory statement, as well as part of ongoing verification activities. For ingredients where a review of the supplier’s allergen programs suggests a “moderate to high chance of cross-contact” (e.g., have a shared line) ingredient testing is recommended to approve the supplier and to verify that the supplier is adequately controlling for cross-contact. Although ingredient testing may be appropriate in some instances, PepsiCo submits that a systems-based approach to supplier verification through supplier questionnaires and onsite audits without ingredient testing can be appropriate because it is a is risk-based and preventive approach.
As a company with over 7000 supplier sites, we have comprehensive processes in place to evaluate supplier practices and make informed food safety determinations. With respect to allergens, we verify that our suppliers have the right systems in place to control for allergen cross-contact prior to supplier approval through the use of an initial supplier questionnaire, evaluation of allergen advisory statements, third-party audits, and confirmation of validated allergen practices. Our supplier verification activities include annual audits, as well as requiring suppliers to inform us when they have a change in practices, among others. We have found that these practices provide adequate assurance that our suppliers are adequately controlling allergen hazards, including allergen cross-contact, and would not be further strengthened through verification testing.
1 We note that under the supply chain program regulations at 21 CFR Subpart G, facilities have the flexibility to determine the appropriate verification activity based on the nature of the hazard and the supplier risk, with onsite audits as the default expectation for hazards where there is a reasonable probability of serious adverse health consequences or death.
3 Indeed, as FDA acknowledges, testing can come with its own limitations. As a threshold matter, performing allergen testing across different food matrices requires unique test methodologies to ensure fit for purpose testing, which is burdensome, time consuming, and may still lead to inconsistent results. Moreover, unintended allergens due to cross contact may not be homogenously distributed throughout the ingredient material. Thus, a systemic approach to verifying allergen control practices can provide greater confidence the supplier is managing cross-contact risks appropriately.
We also are concerned that if the Draft Guidance is interpreted to create an expectation for verification testing of ingredients that are produced on a shared line, this could lead companies to divert resources away from what may be other, more pressing food allergen issues. Based on our own experience, supplier controls were not a contributing factor in our allergen recalls and recent data show that problems related to supply chain controls accounted for only 6.5% of allergen food recalls from 2013 to 2019.2 Moreover, although packaging and labeling errors and production errors such as the use of undeclared rework or the wrong ingredient can lead to high levels of allergen residues in foods, the unintended presence of an allergen in an ingredient is likely to lead to comparatively low levels of allergen residues. Therefore, we encourage FDA to revise the Draft Guidance to include additional examples where there is a risk of cross-contact at the supplier’s facility, but the receiving company’s supply chain program takes a systemic approach to supplier approval and does not include ingredient testing. This will reinforce the flexibility companies have when designing supply chain programs and help ensure they are risk-based and preventive.
(3) The Draft Guidance should be revised to reinforce the flexibility companies have in selecting GMPs and deciding whether to elevate one or more GMPs to a preventive control.
GMPs are the backbone of a sound food safety program. We agree with FDA that GMP measures should be in place before conducting a hazard analysis and identifying risk-based preventive controls to address specific hazards. We also appreciate FDA stating that there may be instances where it is appropriate to adapt one or more of the GMP measures to function as a preventive control by adding management components. However, we urge FDA to include additional statements in the Draft Guidance to reinforce that although companies do have the flexibility to elevate a GMP to a preventive control if the hazard analysis concludes that is appropriate and necessary, there is not an expectation that all GMPs should become preventive controls to control for allergens. For example, ingredient identification (e.g., color coding) and storage may be GMPs at one facility and a preventive control at another. Indeed, elevating all GMPs to preventive controls would dilute the efficacy of existing preventive controls by diverting the existing resources, time, and focus they deserve.3
2 Gidhari Sharma et al., Recalls Associated with Food Allergens and Gluten in FDA-Regulated Foods from Fiscal Years 2013 to 2019, 86 J. of Food Protection 4 (April 2023). Available at https://www.sciencedirect.com/science/article/pii/S0362028X23067418?via%3Dihub. 3 We note that because labeling issues continue to be a driver of food allergen related recalls, labeling programs often are an area of focus for PepsiCo. In contrast, in our experience, unintended allergen presence due to the failure of GMPs to prevent allergen cross-contact is a lower public health risk and less frequently the cause of recalls, and therefore those programs do not necessarily need to be managed as a preventive control. Each manufacturing facility should put in place the type of controls that are appropriate to the facility and the food.
4 In addition, we recommend FDA revise Appendix 11-1 CGMP Measures to Prevent Allergen Cross Contact to emphasize that the examples are illustrative and that facilities are not expected to implement all measures identified. Although many measures are appropriate, some are not conducive or appropriate for all facilities and operations. For example, practices designed to prevent cross-contact from allergen dust must be based on risk. Measures such as enclosed equipment or segregated break rooms may not be necessary or feasible. Facilities have the flexibility to implement GMPs appropriate to their operations to address allergen cross- contact risk.
(4) FDA should recognize food allergen thresholds, such as those established by FAO/WHO.
PepsiCo appreciates FDA’s recognition in the Draft Guidance that published data on population threshold dose responses to various food allergens are available and that these data “raise the possibility that some low-level exposures to food allergens and the presence of certain allergen- derived ingredients may not cause allergic reactions in most consumers who have that allergy.” We support the statements in the Draft Guidance that manufacturers can use such data in their risk assessments to determine appropriate food allergen controls and use of advisory allergen statements.
PepsiCo urges FDA to recognize food allergen thresholds already established more formally. In particular, we suggest that FDA provide a direct reference within the Draft Guidance to the threshold values established in Remington et al., 2020 and the FAO/WHO, 2021 and 2022 reports for clarity and consistency. Global, science- based allergen thresholds benefit consumers and food manufacturers alike by driving towards uniformity, allowing manufacturers to make consistent decisions regarding advisory labeling and consumers to make informed consumption decisions.
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Thank you for the opportunity to comment on this important topic. Please do not hesitate to contact us if we can provide any further information.
