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December 15, 2014 By Electronic Submission Food and Drug Administration Division of Dockets Management (HFA-305) 5630 Fisher Lane, rm. 1061 Rockville, MD 20852

Re: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals; Docket No. FDA-2011-N-0143; RIN 0910-AG64; 79 Fed. Reg. 58574 (Sept. 29, 2014)

Dear Sir or Madam: The Grocery Manufacturers Association (GMA) appreciates the opportunity to share its views regarding the provisions on supplier verification in the Food and Drug Administration’s (FDA) supplemental proposed rule “Foreign Supplier Verification Programs for Importers of Food for Humans and Animals” under the FDA Food Safety Modernization Act (FSMA). GMA is the voice of more than 300 leading food, beverage and consumer product companies that sustain and enhance the quality of life for hundreds of millions of people in the United States and around the globe. Founded in 1908, GMA and its member companies are committed to meeting the needs of consumers through product innovation, responsible business practices, and effective public policy solutions developed through a genuine partnership with policymakers and other stakeholders. In keeping with our founding principles, GMA helps its members produce safe products through a strong and ongoing commitment to scientific research, testing, and evaluation. We ensure that our members have the very best and latest scientific knowledge available so they can provide consumers with the products, tools, and information they need to achieve a healthy diet and an active lifestyle. The $2.1 trillion food, beverage, and consumer packaged goods industry employs 14 million U.S. workers, and contributes over $1 trillion in added value to the nation's economy. GMA supported the passage of FSMA and has adopted a comprehensive program to support its implementation. We appreciate FDA providing an opportunity for public comment on its supplemental proposed rule to implement Section 301 of FSMA. We look forward to continuing to work with the Agency for successful implementation of this groundbreaking law.

Docket No. FDA-2011-N-0143; RIN 0910-AG64; Foreign Supplier Verification Programs for Importers of Food for Humans and Animals: GMA Comments

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Executive Summary We appreciate that FDA has issued a supplemental proposed rule for Foreign Supplier Verification Programs (FSVP). We also appreciate the significant revisions made by the agency, many of which were directly responsive to industry comments. The original proposed rule needed substantial changes, and we were pleased to see that the supplemental proposal is more risk-based and flexible. Nevertheless, the proposed rule still requires several additional changes in order to be workable and to better align with the existing practices of food companies with a long record of producing safe food. In the comments that follow, we explain the changes needed to make the regulations more outcome-based and to ensure the requirements accommodate the many different ways to determine and execute appropriate supplier verification activities. In general, our recommended revisions to the supplemental proposed rule would provide importers with greater flexibility to design and execute effective foreign supplier verification programs. This overall approach is better for food safety because it encourages critical thinking. Companies will need to use expert judgment to make fact-based and risk-based decisions and be able to justify those decisions to FDA. In this respect, the changes GMA is recommending, if adopted, would ensure the regulatory scheme encourages companies to adopt a culture of food safety – that is, the company does not simply check boxes, but thinks critically about food safety needs; and hence, implements the most effective supplier verification program possible. Flexible requirements also lead to stronger food safety protection in the most cost-effective manner. Areas of Agreement with Supplemental Proposed Rules GMA strongly supports a number of the changes in the supplemental proposed rules that are designed to provide needed flexibility to make the rules more practical and more effective in preventing food safety issues:

Confidentiality of Audit Reports. GMA agrees with FDA that importers need not provide the full audit report to the agency, and need only provide documentation that demonstrates the audit was conducted and that significant deficiencies were addressed through corrective actions. 1 Confidentiality of audit reports promotes food safety by encouraging suppliers to be open and honest about their facilities and records so that any issues can be identified and corrected and it encourages auditors to be robust in their efforts.

Flexibility to Determine Appropriate Supplier Verification Activity and Frequency.

We strongly support FDA’s proposal to provide flexibility for importers to determine the appropriate supplier verification activities and the frequency with which the activities must be conducted, based on the risk evaluation for the food and supplier (i.e., “Option 2” under the original proposal), for hazards that do not present a risk of serious adverse health consequences or death to humans or animals (SAHCODHA). As explained in our

1 As explained in our comments dated January 27, 2014, a significant deficiency would be one that triggers a Reportable Food Registry report. See p. 37 of 67.


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initial comments, importers need flexibility to determine the appropriate verification activities based on their assessment of both food and supplier risk. Option 2, as applied to non-SAHCODHA hazards, appropriately recognizes that making a determination of the appropriate verification activities to apply is the role of qualified individuals, who have knowledge of their ingredients and product applications and therefore are in the best position to design effective food safety programs.

Flexibility to Take a Different Approach if Appropriate for SAHCODHA Hazards.

GMA agrees with FDA’s proposal that an importer should be able to document its determination that a verification activity other than annual onsite audits is appropriate for a supplier with a SAHCODHA hazard. For example, if annual audits for the last several years have always been pristine, and all other factors remain constant, it would be appropriate to decrease the auditing frequency from annually to a frequency that is more commensurate with the risk. Overall, this approach to supplier verification has a greater likelihood of delivering safe food in a cost-effective manner.

No Mandatory Written List of Suppliers. GMA agrees that instead of maintaining a

written list of suppliers, importers should be required to establish and follow procedures to ensure that they use only approved suppliers (or, when necessary and appropriate, unapproved suppliers on a temporary basis). Given the logistical challenges of maintaining a list of suppliers when the list of approved suppliers is constantly changing, many of our members do not maintain a single supplier list but instead have corporate-wide systems in place to confirm ingredients are received only from approved suppliers.

Deemed Compliance. Under the FSVP proposal, a facility is deemed in compliance with the FSVP requirements if it is also in compliance with the supplier verification requirements in the preventive controls rule. GMA agrees with this approach, as it avoids imposing redundant regulatory requirements on importers who are also receiving facilities subject to the preventive controls requirements.

Areas Where Revisions are Needed to Make the Regulations More Flexible

Supplier Verification Should Be Broader Than Simply Verifying Control of Discrete Hazards. Because companies typically look at the supplier’s food safety system as a whole, FDA should recognize that the documentation for supplier verification may not reflect a specific confirmation that the company has “verified that supplier is controlling for X hazard” and the records may not show an itemized listing of each hazard and a corresponding verification activity for each supplier. Rather, documentation may reflect a holistic look at the supplier and their overall food safety system.

The Regulations Should Outline the Factors to be Considered When Approving a Supplier, Rather than the Factors that Must be Considered to Select the Appropriate Verification Tool. GMA supports a requirement to consider both ingredient risk and supplier risk, but many factors related to supplier risk may be


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considered when the company decides to approve a particular supplier, rather than when the company selects the verification tool used to review the potential supplier.

The Hazard Analysis Should Be Revised to Reflect Its Narrower Role in the

Supplier Verification Framework. When conducting supplier verification, the importer or receiving facility is not always procuring a finished food; rather, it is usually procuring ingredients and materials. Therefore, the hazard analysis for supplier verification program has a different scope—i.e., a more narrow scope—than the hazard analysis conducted in developing a food safety plan.

Supplier Verification Programs are Often Established and Implemented at a

Corporate Level. For companies with multiple facilities, supplier verification programs are often established, implemented, and reviewed at the corporate level, rather than at each individual receiving facility. This fact affects FDA’s recordkeeping requirements, and also affects the manner in which FDA can achieve efficient and effective inspections of supplier verification programs. Further, FDA should amend the regulations to state that each importer or receiving facility “must establish or have established for it and implement a risk based supplier program.”

Intra-Company Shipments Should be Exempt from Supplier Verification. We strongly recommend that FDA exempt intra-company shipments (i.e., shipments between two business units owned by the same corporate parent) from supplier verification, as any ingredients or materials will already have been verified by another division of the receiving company. It would be duplicative and would not benefit public health to require a company to verify its own upstream verification procedures.

The Importer or Receiving Facility Should Not Be Required to Obtain a Letter

Documenting that a Customer is Controlling Any Hazards. GMA is concerned that securing a letter each year from customers that control food safety hazards would be a burdensome paperwork exercise and would not improve food safety because a letter is no guarantee that the customer is appropriately controlling the hazard (e.g., through a proper cook procedure).

The Importer or Receiving Facility Should Not be Required to Obtain Letters of Assurance from Farms that are Their Suppliers and Are Exempt from the Produce Safety Rule. The importer or receiving facility should not be required to obtain a letter of assurance every two years from farms exempt from the produce safety rule that they are in compliance with the Federal Food, Drug, and Cosmetic Act (FFDCA). Such a requirement would be burdensome and would not contribute to public health.

Supplier Verification is a Verification Activity; Not a Preventive Control. It is

crucial that FDA recognize that supplier verification is a verification activity and not a preventive control. The activities that are part of a supplier verification program do not directly significantly minimize or prevent hazards and, therefore, are not preventive controls.


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* * * We appreciate the opportunity to submit these comments and look forward to continuing to work with the Agency to ensure FSMA implementation is a success. Keeping food safe for consumers is our top priority. Sincerely,

Leon Bruner, DVM, Ph.D. Executive Vice President Science and Regulatory Affairs & Chief Science Officer


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GMA Feedback and Recommendations on Proposed Rule: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals

21 CFR Part 1.500

TABLE OF CONTENTS Comments on Proposed Regulatory Framework ................................................................................................7

Appendix I ...................................................................................................................................................................... 14


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Comments on Proposed Regulatory Framework Executive Summary We appreciate that FDA has issued a supplemental proposed rule for Foreign Supplier Verification Programs (FSVP). We also appreciate the significant revisions made by the agency, many of which were directly responsive to industry comments. The original proposed rule needed substantial changes, and we were pleased to see that the supplemental proposal is more risk-based and flexible. Nevertheless, the proposed rule still requires several additional changes in order to be workable and to better align with the existing practices of food companies with a long record of producing safe food. In the comments that follow, we explain the changes needed to make the regulations more outcome-based and to ensure the requirements accommodate the many different ways to determine and execute appropriate supplier verification activities. In general, our recommended revisions to the supplemental proposed rule would provide importers with greater flexibility to design and execute effective foreign supplier verification programs. This overall approach is better for food safety because it encourages critical thinking. Companies will need to use expert judgment to make fact-based and risk-based decisions and be able to justify those decisions to FDA. In this respect, the changes GMA is recommending, if adopted, would ensure the regulatory scheme encourages companies to adopt a culture of food safety – that is, the company does not simply check boxes, but thinks critically about food safety needs; and hence, implements the most effective supplier verification program possible. Flexible requirements also lead to stronger food safety protection in the most cost-effective manner.

A. Areas of Agreement with Supplemental Proposed Rules GMA strongly supports a number of the changes in the supplemental proposed rules that are designed to provide needed flexibility to make the rules more practical, and more effective in preventing food safety issues:

Confidentiality of Audit Reports. GMA agrees with FDA that importers need not provide the full audit report to the agency, and need only provide documentation that demonstrates the audit was conducted and that significant deficiencies were addressed through corrective actions. 2 Confidentiality of audit reports promotes food safety by encouraging suppliers to be open and honest about their facilities and records so that any issues can be identified and corrected and it encourages auditors to be robust in their efforts.

Flexibility to Determine Appropriate Supplier Verification Activity and Frequency.

We strongly support FDA’s proposal to provide flexibility for importers to determine the appropriate supplier verification activities and the frequency with which the activities must be conducted, based on the risk evaluation for the food and supplier (i.e., “Option

2 As explained in our comments dated January 27, 2014, a significant deficiency would be one that triggers a Reportable Food Registry report. See p. 37 of 67.


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2” under the original proposal), for hazards that do not present a risk of serious adverse health consequences or death to humans or animals (SAHCODHA). As explained in our initial comments, importers need flexibility to determine the appropriate verification activities based on their assessment of both food and supplier risk. Option 2, as applied to non-SACODHA hazards, appropriately recognizes that making a determination of the appropriate verification activities to apply is the role of qualified individuals, who have knowledge of their ingredients and product applications and therefore are in the best position to design effective food safety programs.

Flexibility to Take a Different Approach if Appropriate for SAHCODHA Hazards.

GMA agrees with FDA’s proposal that an importer should be able to document its determination that a verification activity other than annual onsite audits is appropriate for a supplier with a SAHCODHA hazard. For example, if annual audits for the last several years have always been pristine, and all other factors remain constant, it would be more appropriate to decrease the auditing frequency from annually to a frequency that is more commensurate with the risk. Overall, this approach to supplier verification has a greater likelihood of delivering safe food in a cost-effective manner.

No Mandatory Written List of Suppliers. GMA agrees that instead of maintaining a

written list of suppliers, importers should be required to establish and follow procedures to ensure that they use only approved suppliers (or, when necessary and appropriate, unapproved suppliers on a temporary basis). Given the logistical challenges of maintaining a list of suppliers when the list of approved suppliers is constantly changing, many of our members do not maintain a single supplier list but instead have corporate-wide systems in place to confirm ingredients are received only from approved suppliers.

Deemed Compliance. Under the FSVP proposal, a facility is deemed in compliance with the FSVP requirements if it is also in compliance with the supplier verification requirements in the preventive controls rule. GMA agrees with this approach, as it avoids imposing redundant regulatory requirements on importers who are also receiving facilities subject to the preventive controls requirements.

B. Areas Where Revisions are Needed to Make the Regulations More Flexible

GMA appreciates that the supplemental proposals provide importers and receiving facilities with ability to select the appropriate verification activities and the frequency of those activities for each facility. We are concerned, however, that other aspects of the regulations remain overly prescriptive. Greater flexibility within the regulatory requirements is needed to accommodate different approaches to supplier verification that can all result in safer food. In particular, greater flexibility is needed to accommodate current leading practices that result in successful programs. As we commented to the original proposed rule, the Agency’s regulation of supplier verification should not establish a new paradigm, but rather should account for current successful industry-developed practices.


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Further, greater flexibility is needed to account for the diversity and complexity of the food supply chain. There are many different kinds of ingredients and food materials that are procured, and there is a diverse range of end uses for those ingredients and food materials. There are also many different types of suppliers and different relationships between customers and suppliers. In addition, large companies procure thousands of food materials from thousands of suppliers from locations both domestic and foreign. Codified requirements for supplier verification programs need to be flexible enough to address these complex and diverse situations and allow companies to tailor their supplier verification activities to the particular circumstances at hand. At the same time, the regulations should not be overly burdensome with respect to documentation for each scenario. This would not advance the public health, yet would consume considerable resources.

i. Supplier Verification Should be Broader Than Simply Verifying Control of Discrete Hazards

The supplemental proposed rules continue to suggest that the primary purpose of supplier verification is to verify the supplier’s control of a particular hazard (see proposed 117.136(a)(3)(ii) and (a)(4); 1.505(d)(3) and (d)(6)). Rather than focusing on this one element, companies typically look at the supplier’s system as a whole to ensure it is producing a safe product. FDA’s enforcement of supplier verification programs should account for this practice.

In our members’ experience, verification programs often focus on the supplier’s overall food safety system, rather than focus only on a supplier’s control of ingredient-specific hazards. The latter approach could overlook significant aspects of a supplier’s program that could have an important impact on food safety. For example, importers and receiving facilities may assess compliance with prerequisite programs like GMPs and sanitation, which are foundational to enable a company to make safe food, as well as a supplier’s food safety culture, knowledge, and their management’s commitment to continuously improving their program. If supplier verification only considers whether the supplier appropriately applies its CCPs, it may overlook basic deficiencies for essential foundational programs. As a result, supplier verification activities are often systems-based, and not solely hazard-based. Revisions to the codified language are not necessary to address this issue, but we request that FDA recognize the documentation for supplier verification may not reflect a specific confirmation that the company has “verified that supplier is controlling for X hazard.” Further, we ask FDA to recognize that the records may not show an itemized listing of each hazard and a corresponding verification activity for each supplier. Rather, documentation may reflect a holistic look at the supplier and their overall food safety system.

ii. The Regulations Should Outline the Factors to be Considered When Approving a Supplier, Rather than the Factors that Must be Considered to Select the Appropriate Verification Tool

The supplemental proposed rule sets forth the specific factors the importer or receiving facility must consider when selecting verification activities, which include both ingredient risk factors as well as supplier risk factors (proposed Sections 1.505, 117.136(b)), and 507.37(b)). GMA supports a requirement to consider both ingredient risk and supplier risk, as this is a key element


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of a successful supplier verification program. We appreciate FDA’s inclusion of supplier risk as a factor to consider. In practice, however, not all of the factors enumerated in the proposed regulation may be reviewed for each supplier or for each ingredient as part of the analysis to determine or select the appropriate verification activity. Several of these factors may be considered later in the process as part of the decision to approve the supplier or revisit the verification activities selected.

In determining the verification activities, companies typically focus on the hazard, how it is controlled, who is controlling it, and other factors, as appropriate to the particular supplier (i.e., the factors specified in Sections 1.505(a)(1)(i), (ii), and (iii) and 117.136(b)(1)(2), and (3)). The factors listed in 1.505(a)(1)(iv) and (v) and 117.136(b)(4) and (5)—compliance status and performance history—may not be considered in determining the verification activity to conduct, but may be considered at other points in the supplier verification process before ultimately deciding whether to approve a particular supplier. For example, companies typically would not review a supplier’s compliance with FDA regulations as an initial screening activity to determine the verification activity; rather, the supplier’s compliance may be considered later as part of the actual verification and qualification of the supplier (e.g., when conducting the audit or when reviewing their food safety plan records). We therefore request more flexibility with respect to the utilization of the specified factors (i.e., as part of determining the verification activities or as part of determining whether to approve the supplier). Therefore, GMA recommends the regulations provide more flexibility as to which factors are to be considered as part of the risk evaluation and when they must be considered. One option is to revise the language in proposed Sections 117.135(b) and 1.505(a)(1) to clarify that both supplier and material risk must be considered as part of the company’s decision to approve a supplier and provide flexibility in the specific factors considered:

Proposed 117.136(b) Determination and documentation of appropriate verification activities whether to approve a supplier. In determining and documenting the appropriate verification activities whether to approve a supplier, the receiving facility must consider both food and supplier related risks, including the following as appropriate: Proposed 1.505 What risk evaluation must I conduct? (a) Evaluation of food and supplier risks. (1) In determining the appropriate supplier

verification and related activities you must conduct whether to approve a supplier, you must consider both the risks associated with the food and the supplier, including the following as appropriate:

iii. The Hazard Analysis Should be Revised to Reflect Its Narrower Role in the

Supplier Verification Framework The hazard analysis requirement for supplier verification under the proposed rules is practically identical to the hazard analysis a company would conduct when creating a food safety plan and determining which preventive controls to apply. Yet, when conducting supplier verification, the importer or receiving facility is not always procuring a finished food; rather, it is usually procuring ingredients and materials. Therefore, the hazard analysis for the supplier verification


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program has a different scope—i.e., a more narrow scope—than the hazard analysis conducted in developing a food safety plan. In the supplier verification context, the hazard analysis focuses on information that is known and relevant to the importer or receiving facility at the time it is conducted consistent with the need to establish appropriate verification activities. For example, the hazard analysis would focus on the inherent risks in the ingredients and materials, but would not necessarily include consideration of factors that affect the finished product. This narrow scope is appropriate because the importer is not identifying where preventive controls are needed, but rather what level of rigor is needed when assessing the supplier. Because the hazard analysis conducted as part of supplier verification is different than that performed in developing a food safety plan, the regulations in Section 1.504(c) should also be different. We recommend that FDA revise proposed Section 1.504(c)(3) by adding the term “as appropriate” to recognize that the hazard analysis is not the same for supplier verification programs as for food safety plans (i.e., “Your hazard evaluation must consider, as appropriate, the effect of the following on the safety of the finished food for the intended consumer:”). GMA further requests that FDA clarify in the preamble to the FSVP final rule that inspectors should not expect to see a hazard analysis for supplier verification of the same kind they will see when reviewing a facility’s food safety plan.

iv. Supplier Verification Programs are Often Established and Implemented at a Corporate Level

For companies with multiple facilities, supplier verification programs are often established, implemented, maintained, and reviewed at the corporate level, rather than at each individual receiving facility. Similarly, not all contract manufacturing facilities establish their own supplier verification programs; instead, their supplier verification programs may be established and managed by their customer (the brand name company). This affects FDA’s recordkeeping requirements, but also FDA inspections of supplier verification programs. For example, both the knowledgeable individuals who developed and implement the program, as well as the relevant records, may reside at corporate headquarters rather than at the facility. . We ask that FDA recognize in the final rule the often corporate nature of supplier verification programs, and conduct inspections accordingly. In addition, however, a change to the regulations is needed to appropriately recognize that an individual facility may not always create the supplier verification program and that it may instead be established by corporate headquarters. Specifically, FDA should amend the regulations to state that each importer or receiving facility “must establish or have established for it and implement a risk based supplier program.”

v. Intra-Company Shipments Should be Exempt from Supplier Verification GMA continues to recommend that FDA should provide a complete exemption from supplier verification for intra-company shipments. Although we support the flexibility in the proposed rule, which provides that performance history and “other factors” are to be considered in determining the verification activity, this is not the same as a complete exemption based on intra-company status. Our understanding is that, under the rule as currently proposed, an importer or receiving facility could take into account the fact that the supplier operates under the same corporate food safety system as a factor in supporting selection of a less rigorous verification


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activity, but that this flexibility would not rise to the level of a full exemption for the intra-company supplier. As explained in our previous comments on the original preventive controls for human food proposed rule and FSVP proposed rule, we strongly recommend that FDA exempt intra-company shipments (i.e., shipments between two business units owned by the same corporate parent) from supplier verification, as any ingredients or materials will already have been verified by another division of the receiving company. It would be duplicative and not benefit public health to require a company to verify itself. This applies to both international shipments (e.g., importation from a foreign affiliate) as well as domestic shipments (e.g., from a domestic affiliate). FSVP is intended to establish a mechanism for companies to have additional insight to their suppliers to ensure safe food enters the country. Supplier verification considers risks presented by the supplier and the food. Companies already have full insight about the foods they make themselves as well as their own history in supplying the food/ingredients within the company.

vi. Letters of Assurance from Customers Controlling Food Safety Hazards Are Not Necessary for Food Safety

FDA has proposed that where the customer is controlling any hazard, the importer or receiving facility must annually obtain a letter of assurance from the customer that it is controlling the hazard. GMA is concerned that securing such a letter each year is not necessary for food safety, but would be a burdensome paperwork exercise. Significantly, a letter is no guarantee that the customer is appropriately controlling the hazard (e.g., through a proper cook procedure). Furthermore, while suppliers can communicate the hazards associated with a food and the proper mitigation steps to reduce or eliminate this hazard; fundamentally, facilities are not able to police their customers (i.e. receiving facilities downstream in the supply chain). It is the responsibility of each party in the supply chain to understand the products and ingredients it receives, analyze the potential hazards in those materials, and manage them appropriately. This is the fundamental principle of FSMA. A letter from the customer is not necessary for food safety because the customer has an independent legal responsibility to assess and control hazards within its facility. Further, a food manufacturer could potentially have thousands of different end-users (e.g., retailers) of one product, and in some cases may not know the identity of all end-users. As an example, a manufacturer could sell a raw cookie dough product to a food distributor, which might then sell the product to thousands of retail customers, which are responsible for performing a cook step to kill the microbiological hazard. It would be extremely burdensome for the manufacturer to obtain documentation from each retailer. (It is also unlikely the food distributor would issue a letter because they are not the entity performing the cook step). Accordingly, even if obtainable, such a letter is not necessary to food safety and would simply add burden and consume resources.3 Therefore, GMA recommends FDA delete the proposed requirement for documentation that the customer is controlling the hazard(s).

3 A requirement to provide documentation from each customer also becomes a business confidentiality issue as a letter from each customer would reveal a company’s entire customer base.


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vii. The Importer or Receiving Facility Should Not be Required to Obtain Letters of Assurance from Farms that are Their Suppliers and Are Exempt from the Produce Safety Rule

Similarly, the importer or receiving facility should not be required to obtain a letter of assurance every two years from farms exempt from the produce safety rule that they are in compliance with the Federal Food, Drug, and Cosmetic Act (FFDCA) (see proposed Sections 1.506(d)(4), 117.136(c)(4), 507.37(c)(4)). Such a requirement would be burdensome and would not contribute to public health. FDA exempted these farms from the produce safety rule precisely because it considered them to present a very low risk. For example, FDA stated that foods that are rarely consumed raw or that receive commercial processing that adequately reduces the presence of microorganisms of public health significance “pose minimal or no risk.” See 78 Fed. Reg. 3504, 3527 (Jan. 16, 2013). Consistent with this recognition, it is appropriate to exempt such farms from supplier verification activities as well. Further, in many situations it would not be feasible to trace the specific farm that supplied produce due to industry handling practices. Sometimes our members are not able to ascertain the specific farm that harvested a given food. For example, our members often purchase ingredients from brokers, cooperatives, distributors, or traders rather than directly from the ingredient harvester. One example of this challenge is with certain commingled raw agricultural commodities, like spices and coffee. For example, many hundreds of small farmers may grow a certain crop and then deliver it to a co-op where the food is commingled and shipped to the importer. Sometimes the importer is unable to determine the specific identity of each individual farmer to engage in supplier verification (e.g., to audit their program for appropriate application of pesticides) or the number of individual suppliers is resource-prohibitive to verify directly. Accordingly, GMA recommends that FDA delete the proposed requirements in Sections 1.506(d)(4) and 117.136(c)(4) to document assurances from farms exempt from the produce safety rule, as this would be an exercise in paperwork with no benefit to food safety.

viii. Supplier Verification is a Verification Activity; Not a Preventive Control Finally, it is crucial that FDA recognizes that supplier verification is a verification activity and not a preventive control. The activities that are part of a supplier verification program do not directly significantly minimize or prevent hazards. For example, conducting an onsite audit of a supplier does not itself control any hazards, but rather provides confidence in (or raises questions about) the supplier’s food safety system. Because supplier verification programs do not directly control hazards, they are not preventive controls. The regulations should be revised to reflect that supplier verification programs are not preventive controls. Specifically, FDA should delete “supplier controls” from the list of “Preventive Controls” in proposed Section 117.135(c)(4) and should revise the title of proposed Section 117.136 (“Supplier program”) to read “Supplier verification programs.”


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Appendix I

GMA Feedback and Recommendations on Proposed Rule: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals

21 CFR Part 1.500

Detailed Comments

GMA has provided a structured approach to the comments below; the format of which is described here. First, the section of the proposed rule to be discussed is quoted. This is followed by a section entitled “GMA Feedback” where general comments and suggestions on the particular proposed rule section are presented. This is subsequently followed by a section entitled “GMA Recommends” where specific recommendations are made for changes to the proposed rule language and other items. The proposed changes in the language are presented as follows; text that is recommended as being deleted is noted with a strikethrough (strikethrough) and text that is recommended as being added is noted by being underlined (underlined). Italics (italics) are used for emphasis. ______________ Proposed Rule § 1.502 What foreign supplier verification program (FSVP) must I have? (a) General. Except as specified in paragraph (b) of this section, for each food you import, you must develop, maintain, and follow an FSVP that provides adequate assurances that your foreign supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 418 (regarding hazard analysis and risk-based preventive controls for certain foods) or 419 (regarding standards for produce safety), if either is applicable, and is producing the food in compliance with sections 402 (regarding adulteration) and 403(w) (regarding misbranding with respect to labeling for the presence of major food allergens) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350g, 350h, 342, and 343(w)). GMA Comments

FDA should amend the regulations to state that each importer or receiving facility “must establish or have established for it and implement a risk based supplier program.” This approach appropriately recognizes that the facility may not always create the program and that it may instead be established by corporate headquarters. This revised language also recognizes that where contract manufacturers are used, the brand-name company may in some cases establish the supplier verification program and prescribe for the contract manufacturer which suppliers are approved and are to be used.


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GMA Recommends FDA modify the language in proposed § 1.502(a) as follows:

§ 1.502 What foreign supplier verification program (FSVP) must I have? (a) General. Except as specified in paragraph (b) of this section, for each food you import, you must develop, or have developed for you, maintain, and follow an FSVP that provides adequate assurances that your foreign supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 418 (regarding hazard analysis and risk-based preventive controls for certain foods) or 419 (regarding standards for produce safety), if either is applicable, and is producing the food in compliance with sections 402 (regarding adulteration) and 403(w) (regarding misbranding with respect to labeling for the presence of major food allergens) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350g, 350h, 342, and 343(w)).

______________ Proposed Rule § 1.502 What foreign supplier verification program (FSVP) must I have? (c) Importers subject to section 418 of the Federal Food, Drug, and Cosmetic Act. If you are required to establish and implement a risk-based supplier program under § 117.136 or § 507.43 of this chapter for a food you import and you are in compliance with that section, then you are deemed to be in compliance with the requirements of this subpart, except for the requirements in § 1.509. GMA Comments

GMA agrees with this approach, which avoids imposing redundant regulatory requirements on importers who are also receiving facilities subject to the preventive controls requirements.

GMA Recommends None

______________ Proposed Rule § 1.504 What hazard analysis must I conduct? (a) Requirement for a hazard analysis. You must identify and evaluate, based on experience, illness data, scientific reports, and other information, known or reasonably foreseeable hazards for each type of food manufactured, processed, packed, or held at your facility to determine whether there are significant hazards. GMA Comments

As discussed in our comments to the preventive controls supplemental proposed rule, it would be confusing to use the agency’s proposed term “significant hazard,” because as the agency notes in the preamble, “[t]he term ‘significant hazard’ has sometimes been


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used in the context of HACCP to refer to the hazards to be addressed in a HACCP plan through CCPs.” 4

GMA recommends the agency avoid using terms that are used in the HACCP context in the proposed hazard analysis requirements.

GMA suggests that because the definition of “significant hazard” is sufficiently clear, the use of a term such as “significant hazard” is not needed. The regulation would be equally strong if it used the definition, instead of the term itself.

If the Agency feels a term must be used, we propose the term “food safety hazard.” The proposed definition is similar to “food safety hazard” as defined by ISO 220005.

GMA Recommends

FDA modify the language in proposed § 1.504 as follows: (a) Requirement for a hazard analysis. (1) You must identify and evaluate, based on

experience, illness data, scientific reports, and other information, known or reasonably foreseeable hazards for each type of food manufactured, processed, packed, or held at your facility to determine whether there are significant hazards. hazards for which a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would, based on the outcome of a hazard analysis, establish controls to significantly minimize or prevent the hazard in a food and components to manage those controls (such as monitoring, corrections or corrective actions, verification, and records) as appropriate to the food, the facility, and the nature of the control.

Alternatively, FDA could replace the word “significant” with “food safety.” (a) Requirement for a hazard analysis. (1) You must identify and evaluate, based on

experience, illness data, scientific reports, and other information, known or reasonably foreseeable hazards for each type of food manufactured, processed, packed, or held at your facility to determine whether there are significant food safety hazards.

______________ Proposed Rule § 1.504 What hazard analysis must I conduct? (c) Hazard evaluation. (3) Your hazard evaluation must consider the effect of the following on the safety of the finished food for the intended consumer:

4 79 Fed. Reg. at 58542. 5 In section 3.3, ISO 22000:2005(E) defines a food safety hazard as a “biological, chemical or physical agent in food, or condition of food, with the potential to cause an adverse health effect.”


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GMA Comments GMA recommends that FDA add the term “as appropriate” to recognize that the hazard

analysis is not the same for supplier verification programs as for food safety plans. GMA Recommends

FDA modify the language in proposed § 1.504(c)(3) as follows: (c) Hazard evaluation. (3) Your hazard evaluation must consider, as appropriate, the effect of the following on the safety of the finished food for the intended consumer:

GMA further requests that FDA clarify in the preamble that inspectors should not expect to see a hazard analysis for supplier verification of the same kind they will see when reviewing a facility’s food safety plan.

________________ Proposed Rule § 1.504(g) Significant hazards controlled by you and/or your customer. If the preventive controls that you and/or your customer implement in accordance with subpart C of part 117 of this chapter are adequate to significantly minimize or prevent all significant hazards in a food you import, you are not required to determine what foreign supplier verification and related activities you must conduct under § 1.505 and you are not required to conduct such activities under § 1.506. If your customer controls one or more such hazards, you must annually obtain from the customer written assurance that it has established and is following procedures (identified in the written assurance) that will significantly minimize or prevent the hazard. GMA Comments

GMA recommends that FDA delete the requirement for documentation that the customer is controlling the hazard(s) since a letter is no guarantee that the customer is appropriately controlling the hazard (e.g., through the proper cook procedure). Even if a letter was obtainable, such a letter would not augment food safety, but would simply add undue costs. While suppliers can communicate the hazards associated with a food and the proper mitigation steps to reduce or eliminate this hazard; fundamentally suppliers cannot police or control their customers. It is the responsibility of the customer to understand the food it is receiving, analyze it for potential hazards, and implement the proper steps to reduce or eliminate the hazard.

GMA Recommends

FDA should delete the requirement for letters from customers as follows: § 1.504(g) Significant hazards controlled by you and/or your customer. If the preventive controls that you and/or your customer implement in accordance with subpart C of part 117 of this chapter are adequate to significantly minimize or prevent all significant hazards in a food you import, you are not required to determine what foreign supplier verification and related activities you must conduct under § 1.505 and you are not required to conduct such activities under § 1.506. If your customer controls one or more


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such hazards, you must annually obtain from the customer written assurance that it has established and is following procedures (identified in the written assurance) that will significantly minimize or prevent the hazard.

______________ Proposed Rule § 1.505 What risk evaluation must I conduct? (a) Evaluation of food and supplier risks. (1) In determining the appropriate supplier verification and related activities you must conduct, you must consider the following: GMA Comments

The regulations should provide more flexibility as to which factors are to be considered as part of the risk evaluation and when they must be considered. Through this flexibility and risk-based approach there will be a greater likelihood of delivering safe food in a cost-effective manner.

GMA Recommends FDA modify the language in proposed § 1.505(a)(1) as follows:

Evaluation of food and supplier risks. (1) In determining the appropriate supplier verification and related activities you must conduct whether to approve a supplier, you must consider both the risks associated with the food and the supplier, including the following as appropriate:

________________ Proposed Rule § 1.506(a) Use of approved suppliers. You must establish and follow a written procedure to ensure that you import foods only from foreign suppliers you have approved based on the risk evaluation you conduct under § 1.505 (or, when necessary and appropriate, on a temporary basis, from unapproved foreign suppliers whose foods you subject to adequate verification activities before using or distributing). You must document your use of these procedures. GMA Comments

GMA agrees that instead of maintaining a written list of suppliers, importers should be required to establish and follow procedures to ensure that they use only approved suppliers (or, when necessary and appropriate, unapproved suppliers on a temporary basis).

GMA Recommends

None ________________ Proposed Rule § 1.506(d) Foreign supplier verification activities. (1) Except as provided in paragraphs (d)(2) and (4) of this section, you must conduct and document one or more of the supplier verification


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activities listed in paragraphs (d)(1)(i) through (iv) of this section for each foreign supplier before using or distributing the food and periodically thereafter. You must determine and document which activity or activities are appropriate, as well as the frequency with which the activities must be conducted, based on the risk evaluation you conduct for the food and the foreign supplier under § 1.505. GMA Comments

GMA strongly supports FDA’s proposal to provide flexibility for importers to determine the appropriate verification activities and the frequency with which the activities must be conducted, based on the risk evaluation for the food and supplier. Through this regulatory approach there will be an increased likelihood of delivering safe food in a cost-effective manner.

GMA Recommends

None ________________ Proposed Rule § 1.506(d)(1)(ii) Sampling and testing of the food.(A) Sampling and testing of a food may be conducted by either the importer or the foreign supplier. GMA Comments

We agree that testing can be conducted by either the importer or the foreign supplier. Verification testing is often more efficient and effective when conducted by the supplier,

rather than the importer or receiver, because, among other factors, lot control can be maintained.

GMA Recommends

FDA should consider collaboration with other industry stakeholders to possibly develop guidance on “test and hold” procedures and when such procedures could be implemented.

________________ Proposed Rule § 1.506(d) Foreign supplier verification activities. (2) When a hazard in a food will be controlled by the foreign supplier and is one for which there is a reasonable probability that exposure to the hazard will result in serious adverse health consequences or death to humans and animals, you must conduct or obtain documentation of an onsite audit of the foreign supplier before initially importing the food and at least annually thereafter, unless you document your determination that, instead of such initial and annual onsite auditing, other supplier verification activities as set forth in paragraph (d)(1) of this section and/or less frequent onsite auditing are appropriate to provide adequate assurances in accordance with paragraph (c) of this section for the food and foreign supplier based on the determination you made under § 1.505.


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GMA Comments GMA agrees with FDA’s proposal that an importer can document its basis for concluding

that an audit of a supplier of a food with a SAHCODHA hazard can be conducted less frequently than annually.

GMA Recommends None

________________ Proposed Rule § 1.506(d) Foreign supplier verification activities. (1)(i)(C) You must retain documentation of each onsite audit, including the audit procedures, the dates the audit was conducted, the conclusions of the audit, any corrective actions taken in response to significant deficiencies identified during the audit, and documentation that the audit was conducted by a qualified auditor. GMA Comments

GMA agrees with FDA that the full audit report should remain confidential. GMA Recommends

None ________________ Proposed Rule § 1.506(d) Foreign supplier verification activities. (4) If a foreign supplier of a food is a farm that is not subject to the requirements in part 112 of this chapter in accordance with § 112.4 regarding the food being imported, the importer need not comply with paragraphs (d)(1) and (2) of this section if the importer: (i) Documents, at the end of each calendar year, that the food provided by the foreign supplier is not subject to part 112 of this chapter; and (ii) Obtains written assurance, at least every 2 years, that the foreign supplier is producing the food in compliance with the Federal Food, Drug, and Cosmetic Act. GMA Comments

FDA should delete the proposed requirement to document assurances from farms exempt from the produce safety rule, as this would be an exercise in paperwork with no benefit to food safety.

GMA Recommends FDA modify the language in proposed § 1.506(d)(4) as follows:

§ 1.506(d) Foreign supplier verification activities. (4) If a foreign supplier of a food is a farm that is not subject to the requirements in part 112 of this chapter in accordance with § 112.4 regarding the food being imported, the importer need not comply with paragraphs (d)(1) and (2) of this section if the importer:


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(i) Ddocuments, at the end of each calendar year, that the food provided by the foreign supplier is not subject to part 112 of this chapter.; and (ii) Obtains written assurance, at least every 2 years, that the foreign supplier is producing the food in compliance with the Federal Food, Drug, and Cosmetic Act.

________________ Proposed Rule

N/A GMA Comments

We strongly recommend that FDA exempt intra-company shipments (i.e., shipments between two business units owned by the same corporate parent) from supplier verification, as any ingredients or materials will already have been verified by another division of the receiving company. It would be duplicative and would not benefit public health to require a company to verify itself.

GMA Recommends

FDA adopt the following language to exempt intra-company shipments: § 1.500 What definitions apply to this subpart? Affiliated party means, with respect to an entity, any other entity that (i) directly or indirectly controls or is controlled by, or is under common control with that entity, and (ii) is subject to a comparable food safety control framework, including but not limited to, adhering to the same corporate food safety policies, risk assessment processes, and corrective action procedures as the controlling entity. For purposes of this definition, “control” means (i) the direct or indirect ownership of more than fifty percent (50%) of the total voting security of every class or other evidences of ownership interest of the entity, or (ii) the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of an entity. For purposes of this definition “entity” means any individual, general partnership, limited partnership, limited liability company, corporation, or joint venture. § 1.501 To what foods do the regulations in this subpart apply? … (g) Imports from affiliated parties of the importer. The regulations in this subpart do not apply to food imported from a foreign supplier that is an affiliated party of the importer.