Foreign Supplier Verification Programs for Importers of Food for Humans and Animals, 58573-58599 [2014-22448]

Download as PDF Vol. 79 Monday, No. 188 September 29, 2014 Part V Department of Health and Human Services tkelley on DSK3SPTVN1PROD with PROPOSALS5 Food and Drug Administration 21 CFR Part 1 Foreign Supplier Verification Programs for Importers of Food for Humans and Animals; Proposed Rule VerDate Sep<11>2014 17:13 Sep 26, 2014 Jkt 232001 PO 00000 Frm 00001 Fmt 4717 Sfmt 4717 E:\FR\FM\29SEP5.SGM 29SEP5 58574 Federal Register / Vol. 79, No. 188 / Monday, September 29, 2014 / Proposed Rules • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the instructions for submitting comments. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Written Submissions 21 CFR Part 1 [Docket No. FDA–2011–N–0143] RIN 0910–AG64 Foreign Supplier Verification Programs for Importers of Food for Humans and Animals AGENCY: Food and Drug Administration, HHS. Proposed rule; supplemental notice of proposed rulemaking. ACTION: The Food and Drug Administration (FDA) is revising certain provisions of the proposed rule, issued in July 2013, on foreign supplier verification programs (FSVPs) for importers of food for humans and animals. We are primarily revising the proposed requirements concerning compliance status review of food and foreign suppliers, hazard analysis, and supplier verification activities. We are taking this action in response to the extensive public input we have received regarding these provisions and in coordination with revisions we are concurrently making to the proposed rule on current good manufacturing practice (CGMP) and hazard analysis and risk-based preventive controls for human food. We are seeking public comment on the revised proposed FSVP regulations. We are reopening the comment period on the proposed rule only with respect to the specific provisions identified in this Federal Register document. DATES: Submit either electronic or written comments on the supplemental notice of proposed rulemaking by December 15, 2014. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by December 15, 2014 (see the ‘‘Paperwork Reduction Act of 1995’’ section of this document). ADDRESSES: You may submit comments by any of the following methods, except that comments on information collection issues under the Paperwork Reduction Act of 1995 must be submitted to the Office of Regulatory Affairs, Office of Management and Budget (OMB) (see the ‘‘Paperwork Reduction Act of 1995’’ section of this document). tkelley on DSK3SPTVN1PROD with PROPOSALS5 SUMMARY: Electronic Submissions Submit electronic comments in the following way: VerDate Sep<11>2014 17:13 Sep 26, 2014 Jkt 232001 Submit written submissions in the following ways: • Mail/Hand delivery/Courier (for paper submissions): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Instructions: All submissions received must include the Docket No. (FDA– 2011–N–0143) for this rulemaking. All comments received may be posted without change to http:// www.regulations.gov, including any personal information provided. For additional information on submitting comments, see the ‘‘Comments’’ heading of the SUPPLEMENTARY INFORMATION section of this document. Docket: For access to the docket to read background documents or comments received, go to http:// www.regulations.gov and insert the docket number(s), found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Brian Pendleton, Office of Policy, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 301–796–4614; or Domenic Veneziano, Office of Enforcement and Import Operations (ELEM–3108), Office of Regulatory Affairs, Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857, 301–796–6673. SUPPLEMENTARY INFORMATION: Table of Contents Executive Summary Purpose of the Supplemental Notice of Proposed Rulemaking Summary of the Revisions to the Proposed Rule Costs and Benefits I. Background A. Proposed Rule on FSVPs B. Public Comments C. Alignment of FSVP Regulations With Potential Supplier Verification Provisions in the Proposed Preventive Controls Regulations D. Decision To Issue Supplemental Notice of Proposed Rulemaking Regarding Certain Preventive Controls Requirements E. Scope of FSVP Supplemental Notice of Proposed Rulemaking II. Revisions to the Proposed Rule A. Compliance Status Review B. Hazard Analysis C. Supplier Verification PO 00000 Frm 00002 Fmt 4701 Sfmt 4702 D. Definitions of Very Small Importers and Very Small Foreign Suppliers E. Other Related Revisions III. Preliminary Regulatory Impact Analysis IV. Paperwork Reduction Act of 1995 V. Analysis of Environmental Impact VI. Comments VII. References Executive Summary Purpose of the Supplemental Notice of Proposed Rulemaking We are revising certain provisions of the proposed rule, issued in July 2013, on FSVPs for importers of food for humans and animals. The revisions primarily concern the proposed rule’s requirements on compliance status review of food and foreign suppliers, hazard analysis, and supplier verification activities. We are issuing these revisions in response to extensive public input we have received regarding these provisions and in alignment with certain revisions we are concurrently making to the proposed rule on preventive controls for human food. Summary of the Revisions to the Proposed Rule One revision to the proposed rule would, consistent with many comments we received, delete the previously proposed section on compliance status review but incorporate some of the provisions into the requirements concerning hazard analysis and evaluation of certain risk factors in determining appropriate foreign supplier verification and related activities. Another revision would modify some of the previously proposed hazard analysis requirements. In accordance with several comments we received, as well as the revised hazard analysis provisions and new supplier program provisions in the revised preventive controls proposal that we are concurrently issuing, the revised FSVP proposal changes the requirement to analyze hazards that are reasonably likely to occur to a requirement to analyze known or reasonably foreseeable hazards to determine if they are significant. Under the revised proposal, a significant hazard would be defined as a known or reasonably foreseeable hazard in a food 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 and components to manage those controls (such as monitoring, corrections and corrective actions, verification, and records), as appropriate to the food, the facility, and the control. E:\FR\FM\29SEP5.SGM 29SEP5 tkelley on DSK3SPTVN1PROD with PROPOSALS5 Federal Register / Vol. 79, No. 188 / Monday, September 29, 2014 / Proposed Rules Other changes related to the proposed hazard analysis requirements that are consistent with the proposed hazard analysis requirements in the preventive controls proposal include requiring analysis of hazards that may be intentionally introduced for purposes of economic gain, requiring evaluation of environmental pathogens in certain ready-to-eat food, and minor changes to other hazard evaluation factors. Another revision to the previous proposed rule would specify that, along with the hazard analysis, the importer must consider other factors primarily related to supplier risks in determining appropriate supplier verification and related activities before importing a food from a particular foreign supplier and thereafter when the importer becomes aware of new information about these risks. These proposed changes respond to numerous comments stating that industry best practice is to base supplier verification activities on an assessment of information about the risks presented by a food as well as by the supplier of the food, rather than focusing primarily on hazards inherent in food. Under the revised proposal, in addition to the hazard analysis, the importer would be required to consider the following in approving suppliers and determining appropriate verification activities: • The entity that will be applying hazard controls, such as the foreign supplier or the foreign supplier’s raw material or ingredient supplier. • The foreign supplier’s procedures, processes, and practices related to the safety of the food. • Applicable FDA food safety regulations and information regarding the foreign supplier’s compliance with those regulations, including whether the foreign supplier is the subject of an FDA warning letter or import alert. • The foreign supplier’s food safety performance history, including results from testing foods for hazards, audit results relating to the safety of the food, and the supplier’s record of correcting problems. • Any other factors as appropriate and necessary, such as storage and transportation practices. We also are revising certain proposed requirements regarding supplier verification measures themselves and related activities. Instead of maintaining a list of their foreign suppliers, importers would be required to establish and follow procedures to ensure that they import foods only from foreign suppliers that they have approved (except, when necessary and VerDate Sep<11>2014 17:13 Sep 26, 2014 Jkt 232001 appropriate, from unapproved suppliers on a temporary basis). Consistent with the revised proposal’s focus on a broader evaluation of risks, we are proposing that, rather than being designed to ensure that identified hazards are adequately controlled, the purpose of importers’ supplier verification activities should be to provide adequate assurances that the foreign supplier produces the food in a manner consistent with FDA’s regulations on preventive controls or produce safety, if either is applicable to the foreign supplier, and to assure that the food is not adulterated and not misbranded regarding allergen labeling. This approach is consistent with the purpose for foreign supplier verification specified in section 805(a)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 384a). After considering comments on the alternative proposals we presented in the 2013 proposed rule regarding supplier verification activities, we are proposing an approach that gives importers the flexibility to determine appropriate verification measures based on food and supplier risks, while acknowledging the greater risk to public health posed by the most serious hazards in foods. Under the revised proposal, based on the risk evaluation the importer conducts, the importer would be required to determine and document what supplier verification activities are appropriate for a particular food and foreign supplier, as well as the frequency with which those activities should be conducted. Appropriate supplier verification activities could include onsite auditing of the foreign supplier, sampling and testing of food, review of the supplier’s food safety records, or some other procedure determined to be appropriate based on the identified risks. However, the revised proposal also specifies that, when there is a hazard in a food that could result in serious adverse health consequences or death to humans or animals (a ‘‘SAHCODHA’’ hazard), an importer would need to conduct or obtain documentation of an onsite audit of the foreign supplier before initially importing the food and at least annually thereafter, unless the importer specifically determined that some other supplier verification activity and/or less frequent auditing would adequately address the identified risks. This requirement would establish a clear verification standard for these most serious food hazards yet permit importers to employ a different PO 00000 Frm 00003 Fmt 4701 Sfmt 4702 58575 approach if they can confirm that the alternative approach will provide adequate assurance that the identified risks are addressed. We tentatively conclude that this revised proposal regarding supplier verification activities strikes an appropriate balance between granting importers the flexibility to adopt riskbased verification measures while increasing the likelihood that importers will apply the most rigorous verification measures to the most serious risks. The revised proposal also would specify that if a foreign supplier is a farm that is not subject to the produce safety regulations, the importer of food from the supplier would not be subject to the ‘‘standard’’ verification requirements previously noted but would instead be required to obtain written assurance biennially that the supplier is producing the food in compliance with the FD&C Act. This proposed change reflects the different treatment of food from such farms under the produce safety regulations and would be consistent with the potential requirement for a supplier program in the preventive controls regulations. In addition, we are proposing to add provisions stating that when importers or their customers are in compliance with the requirements on supplier programs in the proposed preventive controls regulations, the importers would be deemed in compliance with most of the FSVP requirements (in cases involving customer compliance with the supplier program requirements, the importer would need to obtain written assurance of compliance annually from the customer). This proposed change is consistent with our intent, stated in the FSVP and preventive controls proposed rules, to avoid imposing redundant regulatory requirements on food importers who also are food facilities subject to the preventive controls regulations. Finally, we are increasing, from $500,000 to $1 million, the annual sales ceiling used in the proposed definition of ‘‘very small importer’’ and ‘‘very small foreign supplier’’ to be consistent with our revised approach to the proposed definition of ‘‘very small business’’ under the proposed preventive controls regulations. Costs and Benefits We summarize the annualized costs (over a 10-year time period discounted at both 3 percent and 7 percent) of the revised proposed rule in the following table. E:\FR\FM\29SEP5.SGM 29SEP5 58576 Federal Register / Vol. 79, No. 188 / Monday, September 29, 2014 / Proposed Rules 3 percent Annualized Cost ............................................................................................................................................... Reduction in Cost Relative to Original Option 1 ............................................................................................. Reduction in Cost Relative to Original Option 2 ............................................................................................. The reduction in FSVP requirements for importers who also would be subject to the preventive controls regulations, and other proposed changes in the requirements, results in a cost savings of $76 million per year (compared to Option 1 of the 2013 proposed rule). The overall potential net benefit from the revised proposed rule is estimated at $714 million per year. These figures are based on a 3 percent discount rate, a scenario for inflation, over 10 years. (The figures are the same for a 7 percent discount rate.) Although the FSVP proposed rule would not itself establish safety requirements for food manufacturing and processing, it would benefit the public health by helping to ensure that imported food is produced in a manner consistent with other applicable food safety regulations. The Preliminary Regulatory Impact Analyses for the proposed rules on preventive controls for human food and standards for produce safety consider and analyze the number of illnesses and deaths that the proposed regulations are aimed at reducing. The greater the compliance with those regulations, the greater the expected reduction in illnesses and deaths as well as the costs associated with them. The FSVP regulations would be an important mechanism for improving and ensuring compliance with the previously noted food safety regulations as they apply to imported food. For this reason, we account for the public health benefits of the FSVP proposed rule in the preventive controls, produce safety, and other applicable food safety regulations instead of in this rule. tkelley on DSK3SPTVN1PROD with PROPOSALS5 I. Background A. Proposed Rule on FSVPs On July 29, 2013, FDA published in the Federal Register a proposed rule entitled ‘‘Foreign Supplier Verification Programs for Importers of Food for Humans and Animals’’ (‘‘the 2013 FSVP proposed rule’’ or ‘‘the previous proposed rule’’) (78 FR 45730) to require importers to perform certain activities to help ensure that the food they bring into the United States is produced in a manner consistent with U.S. standards. FDA proposed the FSVP regulations as part of our implementation of the FDA Food Safety Modernization Act (FSMA) (Pub. L. 111–353). Section 301 VerDate Sep<11>2014 17:13 Sep 26, 2014 Jkt 232001 of FSMA adds section 805 to the FD&C Act to require persons who import food into the United States to perform riskbased foreign supplier verification activities for the purpose of verifying the following: (1) The food is produced in compliance with section 418 (concerning hazard analysis and riskbased preventive controls) or 419 (concerning standards for the safe production and harvesting of certain fruits and vegetables that are raw agricultural commodities (RACs)) of the FD&C Act (21 U.S.C. 350g and 350h), as appropriate; (2) the food is not adulterated under section 402 of the FD&C Act (21 U.S.C. 342); and (3) the food is not misbranded under section 403(w) of the FD&C Act (21 U.S.C. 343(w)) (concerning food allergen labeling). Section 805(c) of the FD&C Act directs FDA to issues regulations on the content of importers’ FSVPs. The FSVP proposed rule would require food importers to adopt programs to ensure that the food they import meets the previously noted statutory standards. The previous proposed rule would have required importers to take the following actions as part of their FSVPs: • Use a qualified individual to perform most FSVP activities. • Review the compliance status of foods and foreign suppliers. • Analyze the hazards reasonably likely to occur with foods. • Determine and perform appropriate foreign supplier verification activities for foods. As discussed in more detail in section II.C.5, the proposal set forth two optional approaches to verification requirements that differ primarily with respect to the verification activities that importers must conduct when a SAHCODHA hazard is present in a food. • Review complaints, conduct investigations of adulterated or misbranded food, take corrective actions when appropriate, and modify the FSVP when it is determined to be inadequate. • Reassess the effectiveness of the FSVP. • Ensure that information identifying the importer is submitted upon entry of a food into the United States. • Maintain records of FSVP procedures and activities. In addition to these ‘‘standard’’ FSVP requirements that would apply to most food importers, the previous proposed PO 00000 Frm 00004 Fmt 4701 Sfmt 4702 7 percent $396,780,114 76,191,228 64,627,341 $397,478,400 75,901,638 64,343,306 rule included modified requirements for the following: • Importers of dietary supplements and dietary supplement components. • Very small importers and importers of food from very small foreign suppliers. • Importers of food from foreign suppliers in countries whose food safety systems FDA has officially recognized as comparable or determined to be equivalent to the U.S. food safety system. B. Public Comments We requested comments on the FSVP proposed rule by November 26, 2013. We extended the comment period for the proposed rule and its information collection provisions (which are subject to review by OMB under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501–3520)) (78 FR 69602, November 20, 2013). The comment period for the proposed rule closed on January 27, 2014. After we published the FSVP proposed rule in July 2013, we held two public meetings to solicit stakeholder and public comments on the proposed rule, inform the public about the rulemaking process, and respond to questions about the proposed rule (see 78 FR 57320, September 18, 2013). We also made other presentations, participated in Webinars, and met with stakeholders in the United States and abroad to discuss the FSVP proposed rule along with proposed rules implementing other FSMA provisions. Over 350 comments were submitted to the docket on the FSVP proposed rule. We continue to review these comments as part of our development of the final rule on FSVPs. However, for the reasons discussed in sections I.C through I.E, we are issuing revisions to certain provisions in the previous proposed rule and requesting comment on the revisions. C. Alignment of FSVP Regulations With Potential Supplier Verification Provisions in the Proposed Preventive Controls Regulations In the FSVP proposed rule, we stated that we recognized the importance of coordinating the FSVP regulations with any supplier verification provisions that might be included in the regulations on preventive controls for human and animal food (78 FR 45730 at 45740 to E:\FR\FM\29SEP5.SGM 29SEP5 Federal Register / Vol. 79, No. 188 / Monday, September 29, 2014 / Proposed Rules tkelley on DSK3SPTVN1PROD with PROPOSALS5 45741, 45747 to 45748). We had first expressed that intent in the proposed rule on ‘‘Current Good Manufacturing Practice and Hazard Analysis and RiskBased Preventive Controls for Human Food’’ (the ‘‘Preventive Controls proposed rule’’) (78 FR 3646, January 16, 2013). Although the Preventive Controls proposed rule did not include specific regulations on supplier verification, the Agency requested comment on when and how approval and verification of suppliers of raw materials and ingredients are an appropriate part of preventive controls, and sought comment on different aspects of supplier approval and verification programs (78 FR 3646 at 3665 to 3667). We also stated that we intended to align any supplier verification provisions in the preventive controls regulations with the FSVP regulations to avoid imposing duplicative requirements on entities that are subject to each of those sets of regulations because they are both registered food facilities and food importers. We expressed a similar intent regarding alignment with any supplier verification provisions that might be included in the proposed regulations on preventive controls for animal food (see ‘‘Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals,’’ 78 FR 64736 at 64808, October 29, 2013). In the FSVP proposed rule, we requested comment on how to address foreign supplier verification by importers who could be subject to both the FSVP and preventive controls regulations to avoid imposing duplicative requirements on such firms. In particular, we requested comment on whether the FSVP regulations should state that if an importer was required to establish a supplier approval and verification program under the preventive controls regulations for a food, and was in compliance with those regulations, the importer would be deemed to be in compliance with the FSVP regulations that address those matters (78 FR 45730 at 45748). D. Decision To Issue Supplemental Notice of Proposed Rulemaking Regarding Certain Preventive Controls Requirements In December 2013, we issued a statement (Ref. 1) noting the extensive input we had received from produce farmers and others in the agricultural sector on the Preventive Controls proposed rule and FDA’s 2013 proposed rule on ‘‘Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption’’ (‘‘the VerDate Sep<11>2014 17:13 Sep 26, 2014 Jkt 232001 Produce Safety proposed rule’’) (78 FR 3504, January 16, 2013). We expressed our belief that significant changes would be needed in key provisions of the two proposed rules affecting small and large farmers, such as certain provisions affecting mixed-use facilities (i.e., facilities co-located on a farm). We also announced our intent to propose revised regulatory requirements and request comment on them, allowing the public the opportunity to provide input on our new thinking. We noted that there might be other revisions to these proposed rules that we would issue for public comment, and that we would determine the scope of the revised proposals as we completed our initial review of the submitted comments on the proposed rules. E. Scope of FSVP Supplemental Notice of Proposed Rulemaking In accordance with our December 2013 statement, elsewhere in this issue of the Federal Register we are issuing a supplemental notice of proposed rulemaking regarding the preventive controls for human food proposed rule (‘‘Preventive Controls supplemental document’’) and a supplemental notice of proposed rulemaking regarding the rule on preventive controls for animal food. In addition to revisions to previously proposed requirements, the Preventive Controls supplemental document includes proposed provisions on supplier programs for food facilities that receive raw materials and ingredients. To align the FSVP proposed regulations with the provisions on supplier programs in the revised Preventive Controls proposed rule, and in response to comments that we have received concerning certain related issues in the FSVP proposal, we are revising the FSVP proposed rule. As discussed in detail in section II, the principal changes to the FSVP proposal include the following: • Deleting the previously proposed section requiring importers to conduct a compliance status review of the food and foreign supplier but incorporating some parts of this section into the previously proposed requirement to conduct a hazard analysis of the food and a newly proposed requirement to evaluate other risks associated with the food and foreign supplier. • Replacing the previously proposed requirement to analyze hazards that are ‘‘reasonably likely to occur’’ with a proposed requirement to analyze ‘‘known or reasonably foreseeable’’ hazards to determine if they are significant (i.e., necessitate control measures). PO 00000 Frm 00005 Fmt 4701 Sfmt 4702 58577 • Giving importers the flexibility to conduct the supplier verification activities that they have determined, based on their evaluation of food and foreign supplier risks, can provide adequate assurance that the supplier is producing the food in a manner consistent with U.S. food safety requirements. For foods that are associated with a SAHCODHA hazard, the revised proposal specifically requires initial and subsequent annual onsite auditing of the foreign supplier unless the importer determines, based on its risk evaluation of the food and foreign supplier, that other verification activities are appropriate and adequate. We discuss these revised proposed requirements in section II. We are reopening the comment period on the proposed rule only with respect to these matters. In the FSVP final rule, we will take into account public comments already received and any comments received in response to this document in finalizing the FSVP requirements. The previous proposed rule and the revisions and new provisions in this supplemental notice of proposed rulemaking, taken together, constitute the entirety of the proposed rule on FSVPs. Throughout this document, we discuss revisions to the previously proposed subpart L of 21 CFR part 1 and, in the codified section of this supplemental notice of proposed rulemaking, we list each of the revised and new provisions of proposed subpart L. For the convenience of readers and ease of reference, we prepared a separate document (to be included in the public docket for this rulemaking) that identifies the changes to the previous codified provisions and provides the complete proposed subpart L of 21 CFR part 1, as revised through this document (Ref. 2). II. Revisions to the Proposed Rule As stated in section I.E, in response to comments we have received and as part of our effort to align the FSVP requirements with the supplier program provisions in the revised Preventive Controls proposed rule, we are making several revisions to the FSVP proposed rule. These changes focus primarily on importers’ evaluation of the risks associated with the foods they import and the foreign suppliers of this food, along with the supplier verification activities that importers must conduct. Although we have tried to align the supplier verification provisions in the FSVP and preventive controls regulations as much as possible, there are some differences between the two. These differences are largely due to statutory language and the fact that E:\FR\FM\29SEP5.SGM 29SEP5 58578 Federal Register / Vol. 79, No. 188 / Monday, September 29, 2014 / Proposed Rules while supplier verification is the principal focus of the FSVP regulations, it would only be a component of the preventive controls regulations if it is included in the final preventive controls regulations. These factors result in the two sets of proposed regulations being structured somewhat differently. We request comment, in light of the statutory provisions, on the manner and extent to which the FSVP and preventive controls supplier verification provisions—as well as other aspects of the FSVP and preventive controls regulations—should be aligned in the final rules. tkelley on DSK3SPTVN1PROD with PROPOSALS5 A. Compliance Status Review The previous FSVP proposed rule included two requirements concerning importers’ review of information related to the risk associated with foods and/or foreign suppliers. These are: • A requirement to review the compliance status of each food to be imported and each foreign supplier being considered (previously proposed § 1.504); and • A requirement to analyze the hazards in each food (previously proposed § 1.505). Regarding compliance status review, proposed § 1.504 would have required an importer, before importing a food from a foreign supplier, to assess the compliance status of the food and the foreign supplier, including whether either is the subject of an FDA warning letter, import alert, or requirement for certification issued under section 801(q) of the FD&C Act (21 U.S.C. 381(q)) relating to the safety of the food, to determine whether it would be appropriate to import the food from the foreign supplier. Proposed § 1.504 also would have required an importer to document this review and to continue to monitor and document the compliance status as long as the importer obtains the food from the foreign supplier. 1. Comments We received many comments about the proposed compliance status review provisions. A frequent comment by food importers on the compliance status review requirements is that the proposal places too much emphasis on compliance status review, in particular on warning letters and import alerts, as a basis for determining appropriate supplier verification activities. Several comments maintain that compliance status review should be regarded as just one part of an analysis of the risks associated with a food and the foreign supplier of the food. However, several comments state that supplier verification activities should be based VerDate Sep<11>2014 17:13 Sep 26, 2014 Jkt 232001 not solely on an analysis of the hazards in a food but also on the potential risks associated with a foreign supplier of the food. Some comments state that an importer should consider both positive and negative compliance information about a foreign supplier. One comment states that each importer should determine on its own what information is relevant to review about a supplier’s risk, which might include assessing a supplier’s compliance status. Some comments express concern that certain information about a firm’s compliance status, such as FDA Form 483 inspection reports and consent decrees, could be too difficult to obtain because they might be available only through a request under the Freedom of Information Act. In addition, some comments maintain that the FDA Web site is insufficiently organized and would have to be updated to track food and foreign supplier compliance status. Some comments state that an importer should be free to determine on its own what information about the risk of a foreign supplier is relevant to consider. Many comments express concern that the proposal did not specify how frequently an importer must conduct a compliance status review. Several comments recommend that importers be required to conduct these reviews annually. Some comments object to a continuous monitoring requirement as unnecessary and suggest instead that an importer be required to reassess its supplier’s compliance status as part of the importer’s reassessment of its FSVP when the importer becomes aware of new information about potential hazards associated with the food or supplier. 2. Revisions Regarding Food and Foreign Supplier Risk Evaluation Contrary to how some of the commenters read the proposed requirements, the previous proposal would not have required importers to consider only whether there was a relevant warning letter, import alert, or certification requirement under section 801(q) of the FD&C Act; rather, the importer would have needed to consider information relevant to the compliance status of the food and the foreign supplier, e.g., warning letters and import alerts. The preamble to the 2013 proposed rule discussed other types of information about a food or foreign supplier’s compliance status, such as Form FDA 483s, Establishment Inspection Reports, and recall notices. We agree, however, that importers should consider both food and supplier risks in developing their supplier PO 00000 Frm 00006 Fmt 4701 Sfmt 4702 verification plans. Therefore, we tentatively conclude that it is appropriate to more clearly specify that importers must consider certain information relevant to the risks associated with a food and the foreign supplier. Rather than have a separate section requiring importers to conduct a compliance status review of foods and potential foreign suppliers, we are incorporating these compliance concerns into the proposed risk evaluation requirements. We now are proposing to establish provisions requiring importers to evaluate the risks associated with the food and the potential foreign supplier to determine whether it is appropriate to approve the importation of the food from the foreign supplier. In addition to requiring importers to consider the hazards they determine to be significant under proposed § 1.504 in the revised regulatory text (discussed in section II.B), proposed § 1.505(a)(1) in the revised regulatory text would require importers to consider the following: • The entity that will be applying controls for the identified hazards, such as the foreign supplier or the foreign supplier’s raw material or ingredient supplier. As stated in the preamble to the 2013 proposed rule, we believe that the person who will be controlling a hazard in a food is an important, though not necessarily the only, factor in determining an appropriate supplier verification activity for the food. • The foreign supplier’s procedures, processes, and practices related to the safety of the food. Many comments state that various aspects associated with the manner in which a foreign supplier produces a food can affect the risk associated with the supplier. • Applicable FDA food safety regulations and information regarding the foreign supplier’s compliance with those regulations, including whether the supplier is the subject of an FDA warning letter or import alert. There is widespread acknowledgement among the comments that a foreign supplier’s history of compliance with applicable FDA regulations is an important component (though not the only component) of supplier risk evaluation. Documents such as warning letters and import alerts are available on FDA’s Web site; we tentatively conclude that we would not require importers to consider non-public information regarding compliance with FDA regulations unless such information was available to the importer (e.g., provided to the importer by the foreign supplier). • The foreign supplier’s food safety performance history, including results from testing foods for hazards, audit E:\FR\FM\29SEP5.SGM 29SEP5 tkelley on DSK3SPTVN1PROD with PROPOSALS5 Federal Register / Vol. 79, No. 188 / Monday, September 29, 2014 / Proposed Rules results relating to the safety of the food, and the supplier’s record of correcting problems. Several comments state that an importer typically considers a foreign supplier’s performance in providing products that meet the importer’s specifications, as verified through onsite auditing, testing, or other measures, in determining the form and frequency of verification activities to conduct. • Any other factors as appropriate and necessary, such as storage and transportation practices. We believe that there might be factors not previously specified that in certain circumstances an importer should consider in evaluating food and supplier risks, such as storage and transportation practices or recent changes to the management of a foreign supplier. Proposed § 1.505(a)(2) in the revised proposed regulatory text would require the importer to document each risk evaluation it conducts. We tentatively conclude that this approach to risk evaluation requirements provides a more complete and specific listing (compared to the combined requirements in the previous proposal regarding compliance status review and hazard analysis) of the factors noted by many comments as being the issues that importers typically consider in evaluating food and foreign supplier risks. Under the revised proposal, importers would need to consider each of the previously listed factors in performing their food and foreign supplier risk evaluations. We intend to issue guidance on the specific information that we believe should be considered under each of these factors and how these factors might be weighed in evaluating overall risk. These proposed risk evaluation factors closely align with the factors that receiving facilities must consider in determining appropriate raw material and ingredient supplier verification activities under the supplier program provisions of the revised Preventive Controls proposed rule. We believe that it is not necessary to mandate a specific frequency (e.g., on an annual basis) for a complete reanalysis of the risks associated with a food or foreign supplier. Instead, we believe that an importer should reevaluate food and supplier risks when it obtains new information about these risks, either through the importer’s own investigation or from the foreign supplier, FDA, or some other source. Therefore, proposed § 1.504(b) in the revised regulatory text would require an importer to promptly evaluate the risks associated with a food or foreign supplier when the importer becomes aware of new information about the VerDate Sep<11>2014 17:13 Sep 26, 2014 Jkt 232001 risks. We intend to provide guidance on the circumstances under which importers should reevaluate food and supplier risks. B. Hazard Analysis The other requirement in the previous proposed rule that concerned evaluation of food and supplier risk was the requirement to conduct a hazard analysis. Previously proposed § 1.505(a) would require each importer (with certain exceptions) to determine, for each food imported, the hazards, if any, that are reasonably likely to occur with the food and, for each, the severity of the illness or injury if such a hazard were to occur. The importer would need to document this determination and use it to determine appropriate supplier verification activities. Previously proposed § 1.505(b) states that an importer’s evaluation of the hazards that are reasonably likely to occur with each food that is imported must consider the following potential hazards that may occur naturally or may be unintentionally introduced: Biological hazards, including microbiological hazards such as parasites and environmental pathogens, and other microorganisms of public health significance; chemical hazards, including substances such as pesticide and drug residues, natural toxins, decomposition, unapproved food or color additives, and food allergens; physical hazards; and radiological hazards. Previously proposed § 1.505(c) states that, in evaluating the hazards in § 1.505(b), the importer must consider the effect of several factors on the safety of the finished food for the intended consumer. These factors are as follows: The ingredients of the food; the condition, function, and design of the foreign supplier’s establishment and equipment; transportation practices; harvesting, raising, manufacturing, processing, and packing procedures; packaging and labeling activities; storage and distribution; intended or reasonably foreseeable use; sanitation, including employee hygiene; and any other relevant factors. Previously proposed § 1.505(d) would permit an importer to identify the hazards that are reasonably likely to occur for a particular food by reviewing and evaluating the hazard analysis conducted by the foreign supplier (rather than conducting an entirely separate evaluation of hazards using information that the importer itself has obtained). Finally, under previously proposed § 1.505(e), for a RAC that is a fruit or vegetable, an importer would not be PO 00000 Frm 00007 Fmt 4701 Sfmt 4702 58579 required to conduct a hazard analysis regarding the microbiological hazards that might be reasonably likely to occur with this food. Instead, the importer would need to verify that this kind of food is produced in compliance with FDA’s produce safety standards, once finalized, or equivalent standards. As stated in section II.A.2, our revised proposal would continue to require an importer to analyze the hazards in a food that it imports, with the hazard analysis being one part of the food and foreign supplier risk evaluation that the importer must conduct under § 1.505 in the revised regulatory text. In this section, we discuss certain revisions we are making to the hazard analysis requirements in the proposed rule. 1. Nature of the Hazards That Importers Must Analyze a. Comments Several comments object to the proposed requirement that importers’ hazard analyses focus on hazards that are ‘‘reasonably likely to occur’’ with a food. We proposed to define a hazard reasonably likely to occur as one for which a prudent importer would establish controls or verify that the supplier controls because experience, illness data, scientific reports, or other information provides a basis to conclude that there is a reasonable possibility that the hazard will occur in the type of food being imported in the absence of those controls. One comment states that the ‘‘reasonably likely to occur’’ standard should not be used because it goes beyond and is inconsistent with the ‘‘known or reasonably foreseeable’’ statutory standard in FSMA’s preventive controls provisions (section 418(b)(1) of the FD&C Act). Several comments maintain that the term reasonably likely to occur typically has been used to determine critical control points for hazard analysis and critical control points (HACCP) systems and is inappropriate for use in a program like supplier verification that is a ‘‘prerequisite,’’ foundational food safety program. The comments recommend instead that importers be required to consider ‘‘known or reasonably foreseeable’’ hazards because determining such hazards requires knowledge of the facility in which the food is produced. b. Revisions Regarding Nature of Hazards To Be Evaluated The hazard analysis provisions in both the FSVP and preventive controls previously proposed rules would have required evaluation of hazards that are reasonably likely to occur. As we state E:\FR\FM\29SEP5.SGM 29SEP5 tkelley on DSK3SPTVN1PROD with PROPOSALS5 58580 Federal Register / Vol. 79, No. 188 / Monday, September 29, 2014 / Proposed Rules in the Preventive Controls supplemental document, we acknowledge that it might be confusing to use the phrase ‘‘reasonably likely to occur’’ in both our HACCP regulations and in the preventive controls and FSVP regulations, because the phrase ‘‘reasonably likely to occur’’ has been used as the basis for determining hazards that need to be addressed in a HACCP plan at critical control points. In light of this concern, and consistent with our revision of the hazard analysis provisions in the preventive controls proposed rule, we tentatively conclude that the potential hazards that importers should be required to consider in their risk analyses are hazards that are known or reasonably foreseeable rather than hazards that are reasonably likely to occur. We believe that it is appropriate to align the hazard analysis provisions in the FSVP regulations with those in the proposed preventive controls regulations because hazard analysis is an import component of supplier verification. We now propose to define a ‘‘known or reasonably foreseeable hazard’’ as a potential biological, chemical (including radiological), or physical hazard that is known to, or has the potential to be, associated with a food or the facility in which it is manufactured/processed (§ 1.500 in the revised regulatory text). (We accordingly propose to add a definition of ‘‘facility,’’ which would be defined as a domestic facility or a foreign facility that is required to register under section 415 of the FD&C Act (21 U.S.C. 350d), in accordance with the requirements of 21 CFR part 1, subpart H.) We also are revising the hazard analysis provisions to make clear that they apply to analysis of known or reasonably foreseeable hazards. Section 1.504(a) in the revised regulatory text would require an importer to analyze the known or reasonably foreseeable hazards in a food, based on experience, illness data, scientific reports, and other information, to determine whether they are ‘‘significant’’ hazards. We propose to define a ‘‘significant hazard’’ as a known or reasonably foreseeable hazard 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 and corrective actions, verification, and records), as appropriate to the food, the facility, and the control (§ 1.500 in the revised regulatory text). This means that VerDate Sep<11>2014 17:13 Sep 26, 2014 Jkt 232001 importers must conduct hazard analyses to determine whether any known or reasonably foreseeable hazard in a food poses such a risk to health that it is necessary to establish controls to significantly minimize or prevent the hazard. This definition of significant hazard and the proposed requirement to determine whether known or reasonably foreseeable hazards are significant are consistent with the approach that we are proposing in the supplier program provisions of the preventive controls regulations. 2. Biological Hazards As previously stated, previously proposed § 1.505(b)(1) would require importers to consider whether there are biological hazards in the food they import, including microbiological hazards such as parasites and environmental pathogens, and other microorganisms of public health significance. In the Preventive Controls supplemental document, we are replacing the phrase ‘‘microorganism of public health significance’’ in the proposed preventive controls hazard analysis provisions with the phrase ‘‘pathogen’’ and proposing to define ‘‘pathogen’’ as a microorganism of public health significance. To better align the FSVP requirements with those proposed for preventive controls, we are proposing to describe biological hazards in the same way in § 1.504(b)(1)(i) in the revised regulatory text and adding a definition of ‘‘pathogen’’ to proposed § 1.500. In addition, we are including the same revised definition of ‘‘environmental pathogen’’ as is set forth in the Preventive Controls supplemental document, which proposes to define ‘‘environmental pathogen’’ as a pathogen that is capable of surviving and persisting within the manufacturing, processing, packing, or holding environment such that food may be contaminated and may result in foodborne illness if that food is consumed without treatment to significantly minimize or prevent the environmental pathogen (the definition also specifies that spores of pathogenic sporeformers are not environmental pathogens). 3. Radiological Hazards As previously stated, the proposed rule included radiological hazards among the types of hazards (along with biological, chemical, and physical hazards) that importers must consider in their hazard analyses. a. Comments Some comments maintain that radiological hazards should be included PO 00000 Frm 00008 Fmt 4701 Sfmt 4702 among the chemical hazards rather than in a separate category. One comment states that treating radiological hazards as a separate category would mean that FSMA regulations would differ from Codex and world-wide HACCP standards, which require evaluation only of biological, chemical, and physical hazards, and would create a potential for misunderstanding and lack of acceptance by foreign suppliers. The comment states that making radiological hazards a subset of chemical hazards would help mitigate concerns about a requirement to consider radiological hazards. b. Revisions Regarding Radiological Hazards We tentatively conclude that it is appropriate to consider radiological hazards as a type of chemical hazard. Therefore, we have revised the definition of ‘‘hazard’’ and the reference to radiological hazards in the revised hazard analysis provisions (§§ 1.500 and 1.504(b)(1)(ii), respectively, in the revised regulatory text). However, this does not mean that consideration of radiological hazards would be optional; rather, importers would be required to review such hazards when considering possible chemical hazards in a food. 4. Intentional Hazards In the previous FSVP proposed rule, we stated our tentative conclusion that importers need only consider those hazards that occur naturally or might be unintentionally introduced (78 FR 45730 at 45749). We noted that we planned to address the issue of certain intentionally introduced hazards as part of our rulemaking to implement section 106 of FSMA, which directs FDA to issue regulations to protect against the intentional adulteration of food. But we acknowledged that some kinds of intentional adulterants could be viewed as reasonably likely to occur, such as in foods for which there is a known risk of economically motivated adulteration. Therefore, we requested comment on whether to include in the FSVP requirements potential hazards that may be intentionally introduced for economic reasons. a. Comments Comments were submitted both for and against requiring importers to consider hazards intentionally introduced for economic reasons. One comment states that although importers should consider economically motivated adulterants, most such adulterants should not be regarded as reasonably likely to occur and do not pose a food safety hazard. Some E:\FR\FM\29SEP5.SGM 29SEP5 Federal Register / Vol. 79, No. 188 / Monday, September 29, 2014 / Proposed Rules tkelley on DSK3SPTVN1PROD with PROPOSALS5 comments question the feasibility of determining which economically motivated adulterants should be viewed as reasonably likely to occur. Some comments state that economically motivated adulteration is best addressed through food defense plans. One comment states that importers should not be required to consider intentional hazards, including economicallymotivated hazards, because such hazards require different kinds of preventive measures than those traditionally used in supplier verification programs. b. Revisions Regarding Intentional Hazards We are proposing to add hazards that may be intentionally introduced for purposes of economic gain to the types of known or reasonably foreseeable hazards that an importer would be required to consider in its hazard analysis (see § 1.504(b)(2)(iii) in the revised regulatory text). As discussed in the Preventive Controls supplemental document, several substances, such as melamine and dyes containing lead, have been used in economically motivated adulteration schemes and have potential to harm public health. Because some economically motivated adulterants should be regarded as known or reasonably foreseeable hazards, we believe it is appropriate that importers consider them when conducting hazard analyses. We are no longer proposing that importers analyze hazards that are reasonably likely to occur, so the concerns related to applying that standard to economically motivated adulterants are no longer relevant. In addition, because the proposed regulations define a ‘‘hazard’’ as an agent that is reasonably likely to cause illness or injury in the absence of its control, importers need only consider those economically motivated adulterants that are reasonably likely to harm consumers’ health, not economically motivated adulterants that solely affect quality or value. We disagree with the comment that economically motivated adulteration requires different kinds of preventive measures than those traditionally used in supplier verification programs. Industry currently uses audits, sampling, and testing to verify that hazards are being controlled, including hazards from economic adulteration. Nevertheless, as discussed in section II.C.5, the revised proposed supplier verification requirements provide considerable flexibility to importers in conducting supplier verification, including the ability to determine and implement any appropriate supplier VerDate Sep<11>2014 17:13 Sep 26, 2014 Jkt 232001 verification activity based on the risks associated with the food and foreign supplier. 5. Environmental Pathogens in Certain Ready-To-Eat Food To better align the hazard analysis requirements in the FSVP regulations with those in the proposed preventive controls regulations, we are adding a proposed requirement, in § 1.504(c)(2) in the revised regulatory text, for importers to include in their hazard analysis of a food an evaluation of environmental pathogens whenever a ready-to-eat food is exposed to the environment before packaging and the packaged food does not receive a treatment that would significantly minimize the pathogen. 6. Factors Affecting the Safety of Finished Food Also to better align the FSVP hazard analysis requirements with those in the proposed preventive controls regulations, we are making two minor revisions to the list of proposed items that importers must consider regarding their potential effect on the safety of finished food for the intended consumer. In § 1.504(c)(3)(i) in the revised regulatory text, we are replacing ‘‘ingredients of the food’’ with ‘‘formulation of the food,’’ and in § 1.504(c)(3)(iii) in the revised regulatory text we are adding a requirement to consider ‘‘raw materials and ingredients.’’ C. Supplier Verification We are revising several aspects of the proposed requirements concerning foreign supplier verification procedures and related activities. The revisions include a revised proposal regarding the alternative options presented in the proposed rule concerning appropriate supplier verification activities when foreign suppliers control (or verify control of) hazards in food. 1. List of Foreign Suppliers To help ensure that importers are obtaining food only from appropriate foreign suppliers, previously proposed § 1.506(a) would require each importer to maintain a written list of the foreign suppliers from which they are importing food. The list would also help importers to quickly and accurately identify their foreign suppliers for purposes of conducting FSVP activities such as supplier verification, investigations, and corrective actions, and help ensure consistent performance of these activities by importers’ employees or other qualified individuals. PO 00000 Frm 00009 Fmt 4701 Sfmt 4702 58581 a. Comments Several comments express support for the proposed requirement that importers maintain a list of their foreign suppliers. However, some comments oppose this requirement on the basis that it would present logistical or administrative challenges. Some comments state that it would be burdensome to constantly update the list of foreign suppliers. Some comments suggest that importers instead be required to provide a list of suppliers upon the Agency’s request. One comment states that the identity of suppliers is confidential business information that importers should not be required to disclose to FDA on a routine basis. Some comments state that some importers might not maintain a single list of approved suppliers but use a corporate-wide or centralized system to confirm receipt of food from approved suppliers. These comments instead recommend that importers be required to establish a system that will allow them to confirm that imported food is from a foreign supplier that the importer has approved for use. One comment states that in emergency situations to avoid production disruptions, an importer might need to obtain food from foreign suppliers that they have not audited. The comment maintains that use of food from such suppliers would be acceptable provided that the food is inspected or analyzed before use. b. Revisions Regarding Process for Confirming Receipt of Food From Approved Suppliers. We are uncertain how an importer could verify that a food it receives is from an approved foreign supplier yet be unable to generate a list of such approved suppliers, especially when the importer uses a centralized, corporatewide system. We understand that use of multiple supplier databases could necessitate some compilation procedure, but it does not appear to us that this would be significantly burdensome. Nevertheless, we tentatively conclude that requiring importers to establish a system or procedure to confirm that imported foods are from approved suppliers, rather than maintain a list of foreign suppliers, would enhance the safety of imported food at least as much as merely maintaining a list of suppliers while reducing the apparent administrative burden on importers. Therefore, we have replaced the proposed requirement to maintain a list of foreign suppliers with a proposed requirement, in § 1.506(a) in the revised E:\FR\FM\29SEP5.SGM 29SEP5 58582 Federal Register / Vol. 79, No. 188 / Monday, September 29, 2014 / Proposed Rules tkelley on DSK3SPTVN1PROD with PROPOSALS5 regulatory text, to establish and follow written procedures to ensure that foods are imported from foreign suppliers the importer has approved based on the risk evaluation it conducts under § 1.505 and to document use of these procedures. These procedures might address approval of suppliers, approval or rejection of particular shipments of foods, and documentation of receipt from approved suppliers. It is essential that such procedures be capable of accurately identifying foreign suppliers for purposes of meeting FSVP requirements. However, we believe that, in limited circumstances, it might be appropriate for an importer to use a supplier for which the importer has not completed a full risk evaluation provided that the importer takes other steps to ensure that food from such a supplier is safe. For example, because of a problem with a long-time supplier due to an equipment breakdown, an environmental or weather-related crisis (e.g., severe drought or flooding), or some other unexpected circumstance, it might be necessary for an importer to obtain a food on a temporary basis from a new supplier. Because the importer would be unable to immediately fully evaluate the potential supplier, the importer would need to take other steps to verify that the food obtained from that supplier was safe. Such verification measures might include sampling and testing individual shipments from the supplier. Therefore, revised § 1.506(a) would permit the use of unapproved foreign suppliers on a temporary basis when necessary and appropriate, provided that the importer subjects the food from such suppliers to adequate verification activities before using or distributing the food. The importer’s written procedures regarding the use of approved suppliers also would need to address the circumstances under which unapproved suppliers might be used, and the importer would need to document the verification activities it conducts when using unapproved suppliers. We request comment on circumstances under which it might be necessary and appropriate to receive food from unapproved foreign suppliers and on the types of verification activities that an importer should conduct on food from an unapproved supplier. 2. Purpose of Supplier Verification Section 1.506(c) of the 2013 proposed rule would have required the importer to conduct foreign supplier verification activities to provide adequate assurances that the hazards the importer had identified as reasonably likely to occur were adequately controlled. VerDate Sep<11>2014 17:13 Sep 26, 2014 Jkt 232001 However, we tentatively concluded that this provision should not apply to microbiological hazards in RACs that are fruits or vegetables and that would be subject to the produce safety regulations in proposed part 112 (21 CFR part 112) because importers of these fruits or vegetables would not be required to conduct a hazard analysis regarding the microbiological hazards in this food. Instead, proposed § 1.506(h) stated that verification for these hazards should address whether foreign suppliers are producing these fruits and vegetables in accordance with the produce safety regulations. a. Comments One comment maintains that directing that supplier verification activities be designed to provide assurances that hazards are adequately controlled is inconsistent with the statute and does not focus on the key issues affecting the safety of imported food. The comment states that supplier verification activities should consider not just the hazards in food but supplier-related risks. Some comments maintain that linking supplier verification activities solely to food hazards incorrectly implies that verification controls the hazard and suggests that the supplier can pose no significant safety risks. b. Revisions Regarding Purpose of Supplier Verification We do not believe, nor does the preamble to the 2013 proposed rule state, that supplier verification activities actually control hazards. Rather, a key purpose of verification is to provide assurance that hazards are being effectively controlled by the foreign supplier or some other entity. However, as stated in section II.A.2, we tentatively conclude that importers should consider both food and supplier risks in determining what supplier verification activities to conduct. In accordance with this approach, we believe that the purpose of supplier verification activities should not be limited to verifying control of hazards. Therefore, we now propose to require (in § 1.506(c) in the revised regulatory text) that supplier verification activities provide adequate assurances that the 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 or 419 of the FD&C Act (the preventive controls and produce safety provisions, respectively), if either is applicable, and is producing the food in compliance with sections 402 and 403(w) of the PO 00000 Frm 00010 Fmt 4701 Sfmt 4702 FD&C Act. This more directly links supplier verification activities to the statutory purpose for FSVPs in section 805(a)(1) of the FD&C Act. With this change to the proposed purpose of supplier verification activities, we tentatively conclude that there is no need for a separate requirement concerning supplier verification activities related to microbiological hazards in RACs that are fruits or vegetables subject to the produce safety regulations. With respect to microbiological hazards in such food, under revised § 1.506(c), the importer of the food would need to conduct activities to verify that: (1) The foreign supplier is using processes and procedures that provide at least the same level of protection as those required under the produce safety regulations, when finalized and (2) the food is not adulterated or misbranded regarding allergen labeling. 3. No Hazards Identified Under § 1.506(d) of the previous proposed rule, if an importer determines that no hazards are reasonably likely to occur with a food, the importer would not be required to conduct supplier verification activities. However, under the supplier program provisions in the revised preventive controls proposal, when there are no significant hazards in a raw material or ingredient, the receiving facility would not be required to have a supplier program for the food, including the requirement to determine appropriate verification activities by considering food and supplier risks. To better align the proposed FSVP regulations with the proposed preventive controls regulations, we propose to specify, in § 1.504(f) in the revised regulatory text, that if an importer evaluates the known and reasonably foreseeable hazards in a food and determines that there are no significant hazards, the importer would not be required to determine what foreign supplier verification and related activities it should conduct and would not be required to conduct any such activities. (As under the proposed rule, revised § 1.504(f) states that this exemption would not apply if the food is a RAC that is a fruit or vegetable and that is subject to the produce safety regulations.) 4. Hazards Controlled by the Importer or Its Customer The preamble to the 2013 proposed rule noted that some hazards associated with an imported food are controlled through actions that the importer or its customer takes after the food is brought into the United States. We tentatively E:\FR\FM\29SEP5.SGM 29SEP5 Federal Register / Vol. 79, No. 188 / Monday, September 29, 2014 / Proposed Rules tkelley on DSK3SPTVN1PROD with PROPOSALS5 concluded that if an importer or its customer has established validated preventive controls to ensure that a hazard is adequately controlled through processing in the United States, there would be no need for the importer to conduct a foreign supplier verification activity with respect to that hazard (78 FR 45730 at 45752). Therefore, when an importer is adequately controlling a hazard that it has identified, proposed § 1.506(e) would have required the importer to document, at least annually, that it had established and was following procedures that adequately controlled the hazard. Similarly, when an importer’s customer was controlling a hazard, proposed § 1.506(f) would have required the importer to document that its customer controlled the hazard by obtaining written assurance, at least annually, from the customer that it had established and was following procedures (identified in the written assurance) that adequately controlled the hazard. However, we also requested comment on whether it would be appropriate to deem importers who are in compliance with any applicable supplier verification provisions that are included in the preventive controls regulations to be in compliance with the FSVP requirements, to avoid duplicative regulation of importers who are also registered with FDA as food facilities. We tentatively concluded that, if a provision to this effect were included in the FSVP regulations, proposed § 1.506(e) would be unnecessary, as importers that control hazards in foods they import would be subject to the supplier verification provisions in the preventive controls regulations (78 FR 45730 at 45752). Similarly, we tentatively concluded that proposed § 1.506(f) would be unnecessary if the FSVP regulations were to include a provision stating that an importer whose customer was in compliance with any adopted preventive controls supplier verification provisions was deemed to be in compliance with the FSVP requirements. We requested comment on this proposed approach to supplier verification when the importer or its customer controls a hazard. a. Comments Several comments agree with proposed § 1.506(e) requiring importers who control hazards in food they import to document their control of these hazards. In addition, several comments express support for avoiding imposing redundant verification requirements on importers that would be required to conduct supplier verification under the preventive controls regulations. One VerDate Sep<11>2014 17:13 Sep 26, 2014 Jkt 232001 comment agrees that proposed § 1.506(e) would be unnecessary if importers who were in compliance with supplier verification provisions in the preventive controls regulations were deemed in compliance with the FSVP requirements. One comment states that supplier verification activities should not turn on the entity that is controlling a hazard in a food. The comment states that verification activities may be needed even when the foreign supplier does not control the hazard, adding that importers should not be required to engage in a paperwork exercise to obtain assurances of their customers’ food safety controls. Similarly, another comment opposes not requiring standard verification activities when a hazard is to be controlled by the importer or its customer, maintaining that nearly all suppliers should be subject to verification activities. The comment states that not requiring any supplier verification would overlook important issues such as the supplier’s compliance with CGMP requirements and the need for programs to avoid introducing any unforeseen hazards. The comment also states that the proposal is problematic because the intended use of the food may not be known at the time of entry or different parts of a product batch might be destined for different customers with different processes. However, elsewhere in its submitted comments, the commenter maintains that FDA must harmonize the supplier verification provisions in the preventive controls regulations with the FSVP regulations so that imported ingredients need only be verified once. b. Revisions Regarding Importers Subject to the Supplier Program Provisions in the Preventive Controls Regulations As stated previously in this document, elsewhere in this issue of the Federal Register we are proposing a potential requirement for a supplier program in the proposed preventive controls regulations. Therefore, consistent with the discussion in the 2013 FSVP proposed rule, we propose to specify, in § 1.502(c) in the revised regulatory text, that if an importer is required to establish and implement a risk-based supplier program under the preventive controls regulations (for either human or animal food), and the importer is in compliance with those requirements, the importer would be deemed in compliance with the FSVP regulations (except for the requirement to identify the importer at entry of the food into the United States). Similarly, PO 00000 Frm 00011 Fmt 4701 Sfmt 4702 58583 under § 1.502(d) in the revised regulatory text, if an importer’s customer is required to establish and implement a risk-based supplier program under the preventive controls regulations (for either human or animal food), and the importer annually obtains written assurance that its customer is in compliance with those requirements, the importer would be deemed in compliance with the FSVP regulations (except for the requirement to identify the importer at entry of the food into the United States and the requirement to maintain records of the written assurances). Because the importer or its customer would be performing supplier verification activities under the preventive controls regulations, we tentatively conclude that this approach addresses concerns about a lack of supplier verification when the importer or its customer controls a hazard, while also avoiding imposing redundant verification requirements. However, even though we are proposing to add these provisions regarding importers who are facilities that are subject to the supplier program requirements in the preventive controls regulations, we tentatively conclude that it would not be appropriate to delete the previously proposed provisions concerning foods with hazards to be controlled by the importer or its customer. The reason for this is that we tentatively conclude that it is appropriate to align the FSVP requirements with the potential supplier program provisions discussed in the preventive controls proposed rule, should they be adopted. The potential supplier program requirements would not apply under the following circumstances: • When the preventive controls at the receiving facility are adequate to significantly minimize or prevent each of the significant hazards in a raw material or ingredient; or • When the receiving facility relies on its customer to control the hazard and annually obtains from its customer written assurance that the customer has established and is following procedures (identified in the written assurance) that will significantly minimize or prevent the hazard. In such circumstances, requiring an importer that also is a facility subject to the preventive controls regulations to conduct foreign supplier verification activities would not impose a redundant regulatory burden because such importer-facilities would not also be subject to the preventive controls supplier program requirements. Nevertheless, we tentatively conclude that it still would impose an E:\FR\FM\29SEP5.SGM 29SEP5 58584 Federal Register / Vol. 79, No. 188 / Monday, September 29, 2014 / Proposed Rules tkelley on DSK3SPTVN1PROD with PROPOSALS5 unnecessary burden because the importer’s (and/or its customer’s) control of all significant hazards in the food would effectively resolve the food safety concerns that supplier verification is intended to address. Therefore, we propose to specify, in § 1.504(g) of the revised regulatory text (in the hazard analysis section of the proposed FSVP regulations), that if the preventive controls that an importer and/or its customer implements under the preventive controls regulations are adequate to significantly minimize or prevent all significant hazards in a food, the importer is not required to determine appropriate foreign supplier verification and related activities under § 1.505 and is not required to conduct such activities under § 1.506. Proposed § 1.504(g) further states that if the importer’s customer controls one or more significant hazards in a food, the importer 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. 5. Hazards Controlled by the Foreign Supplier The previous proposed rule set forth two options for the requirements regarding supplier verification activities for hazards that are controlled, or for which control is verified, by the importer’s foreign supplier (see previously proposed § 1.506(g), Options 1 and 2). Option 1 would have established certain requirements for SAHCODHA hazards to be controlled by the foreign supplier, and different requirements for non-SAHCODHA hazards and SAHCODHA hazards that the foreign supplier verified had been controlled by its raw material or ingredient supplier. (The preamble to the 2013 proposed rule described a SAHCODHA hazard as one for which a recall of a violative product posing such hazard is designated as ‘‘Class I’’ under 21 CFR 7.3(m)(1).) Option 2 would have required the importer to determine the supplier verification activity it would use for all hazards that the foreign supplier controlled or for which it verified control. Under Option 1, for a SAHCODHA hazard that was to be controlled at the foreign supplier’s establishment, the importer would have been required to conduct and document certain initial and subsequent periodic (at least annual) onsite audits of the foreign supplier. Onsite auditing also would be required under Option 1 for microbiological hazards in certain RACs that are fruits or vegetables. When VerDate Sep<11>2014 17:13 Sep 26, 2014 Jkt 232001 onsite auditing alone could not provide adequate assurances that such a hazard was adequately controlled, the importer would have had to conduct one or more additional verification activities to provide such assurances. For nonSAHCODHA hazards to be controlled by the foreign supplier and all hazards for which the supplier verified control by its raw material or ingredient supplier, Option 1 would have required that the importer conduct, upon consideration of the risk presented by the hazard and the food and foreign supplier’s compliance status, one or more of the following verification activities before using or distributing the food and periodically thereafter: • Onsite auditing of the foreign supplier. • Periodic or lot-by-lot sampling and testing of the food. • Review of the foreign supplier’s food safety records. • Any other procedure established as being appropriate based on the risk associated with the hazard. On the other hand, Option 2 would have allowed the importer to determine, for all hazards either controlled by the foreign supplier or for which the foreign supplier verified control by its supplier, which of the previously listed verification activities would be appropriate to verify that the hazard was adequately controlled. In determining the appropriate verification activities and how frequently they should be conducted, Option 2 would have required the importer to consider the risk presented by the hazard, the probability that exposure to the hazard would result in serious adverse health consequences or death to humans or animals, and the food and foreign supplier’s compliance status. a. Comment We received many comments in support of Option 1 and many that favor Option 2. Comments in favor of Option 1 include the following: • Option 1 would provide greater protection to consumers than Option 2. • Option 1 is risk-based in that it would require the most rigorous form of supplier verification—onsite auditing— when the most serious hazards are present in food. • Option 2 would provide too much discretion to importers, who would have an incentive to choose lower-cost and less effective verification methods, which could result in an increase in contaminated imported food. • A single, streamlined requirement would be more easily enforced without confusion, and regulated entities often prefer such clarity. PO 00000 Frm 00012 Fmt 4701 Sfmt 4702 • Option 1 would reduce industry costs by avoiding the need for importers to make verification decisions on a product-by-product basis. Comments in favor of Option 2 include the following: • Option 2 would provide importers with the flexibility needed to tailor the supplier verification to the particular food and supplier risk. • Option 2 is more closely aligned with current industry practice, which often uses onsite audits but also relies on other verification methods depending on food and supplier risk. • Option 2 is more risk-based and would result in a better allocation of resources by not requiring onsite auditing when it would not be justified by risk. • Requiring different supplier verification activities for different types of hazards in a food is inconsistent with current industry practice. • Option 1 could lead importers to simply ‘‘check the box’’ that a foreign supplier has been audited rather than analyze the audit results and consider whether additional verification activities are needed. • The SAHCODHA standard is not well understood and might not be workable as a factor for determining supplier verification activities. One comment recommends what it describes as a hybrid of the two options. The comment suggests that annual onsite auditing should be the default requirement for SAHCODHA hazards and for microbiological hazards for RACs that are fruits or vegetables, but an importer would be permitted to use alternative verification measures if it could justify, based on a comprehensive risk assessment, that risks are reduced and that the alternative measures would adequately verify that the foreign supplier adequately controlled the hazards. b. Revisions Regarding Supplier Verification Activities Although we acknowledge the concerns regarding Option 2 expressed by supporters of Option 1, we tentatively conclude that allowing importers the flexibility to determine the appropriate supplier verification activity (or activities) based on the importer’s evaluation of food and supplier risks would be a more riskbased approach. We believe that this would more closely align the verification requirements with Congress’s directive that importers perform risk-based verification activities. In turn, this should result in safer imported food by allowing importers to optimize their verification E:\FR\FM\29SEP5.SGM 29SEP5 tkelley on DSK3SPTVN1PROD with PROPOSALS5 Federal Register / Vol. 79, No. 188 / Monday, September 29, 2014 / Proposed Rules efforts in accordance with the relative risks to public health posed by different foods and suppliers. Therefore, we are proposing, in § 1.506(d)(1) in the revised regulatory text, that importers be required to conduct and document one or more of four supplier verification activities— onsite auditing, sampling and testing of food, review of the foreign supplier’s food safety records, or some other appropriate risk-based verification activity—before initially importing a food and periodically thereafter. The importer would be required to determine and document which verification activity or activities are appropriate, as well as the frequency with which the activities must be conducted, based on the risk evaluation that the importer conducts for the food and supplier under proposed § 1.505. As in both Option 1 and Option 2 under the previous proposed rule, the revised proposal recognizes that for some foods or foreign suppliers it might be necessary to conduct more than one verification activity to provide the required assurances (see § 1.506(d)(3) in the revised regulatory text). The revised proposal states that an onsite audit of a foreign supplier must be conducted by a qualified auditor (§ 1.506(d)(1)(i)(A) in the revised regulatory text), who is defined as a person who is a qualified individual and has technical expertise obtained by a combination of training and experience appropriate to perform the auditing function (§ 1.500 in the revised regulatory text). (The proposed definition also specifies that a foreign government employee could be a qualified auditor.) The revised proposal also states that sampling and testing of a food may be conducted by either the importer or the foreign supplier (§ 1.506(d)(1)(ii)(A) in the revised regulatory text). We are proposing a slight modification to this general rule regarding verification activities in the case of foods with SAHCODHA hazards, similar to the ‘‘hybrid’’ approach suggested by one comment. As expressed by some Option 1 supporters, we believe that requiring onsite auditing when there is a SAHCODHA hazard in a food is risk-based because it would require what is arguably the most robust supplier verification activity—annual onsite auditing—for the most serious hazards in foods. However, we acknowledge the possibility that: (1) Use of some other verification activity, (2) less frequent onsite auditing, or (3) some combination of those two approaches could provide adequate assurances regarding the safety of the food. We also VerDate Sep<11>2014 17:13 Sep 26, 2014 Jkt 232001 recognize that although some importers might prefer the ease of not having to make a determination of appropriate supplier verification activities when a SAHCODHA hazard is present in a food, others would prefer being able to tailor verification activities (and the frequency with which they are conducted) to a particular food and supplier risk profile. For these reasons, we are proposing to require, in § 1.506(d)(2) in the revised regulatory text, that when a SAHCODHA hazard in a food will be controlled by the foreign supplier, the importer must conduct (or obtain documentation of) initial and subsequent annual onsite auditing of the foreign suppler unless the importer determines that other supplier verification activities and/or less frequent onsite auditing are appropriate to provide adequate assurances regarding the safety of a particular food and foreign supplier based on the risk evaluation conducted under § 1.505. This would provide importers with the certainty of knowing that use of initial and subsequent annual onsite auditing would satisfy the verification requirement when a SAHCODHA hazard is present in a food, while allowing importers to use an alternative verification mechanism(s) if they determine that such mechanism(s) provide adequate safety assurances. We do not believe, as some comments suggest, that making onsite auditing mandatory when there is a SAHCODHA hazard in a food or, in the case of our revised proposal, establishing onsite auditing as the ‘‘default’’ verification activity in such circumstances, would result in importers failing to analyze audit results or consider whether additional verification activities are needed. Both the previous proposed rule (§ 1.506(g)(5) under Option 1) and the revised proposal (§ 1.506(d)(6) in the revised regulatory text) would require importers to promptly review the results of their verification activities and, if necessary, take appropriate corrective action. In addition, under both the previous proposed rule (§ 1.506(g)(1) under Option 1) and the revised proposal (§ 1.506(d)(3) in the revised regulatory text), even when an importer conducts an onsite audit or obtains an onsite audit report to verify control of a SAHCODHA hazard in a food, it might be necessary in some circumstances for the importer to conduct some additional verification. We also do not believe that purported uncertainty about the SAHCODHA standard would make it difficult for importers to comply with this provision. FDA’s Reportable Food Registry Questions and Answers document PO 00000 Frm 00013 Fmt 4701 Sfmt 4702 58585 discusses the types of violative products that should be addressed through a Class I recall, which uses the SAHCODHA standard. In addition, the Agency’s weekly FDA Enforcement Report, which is available at FDA’s Web site (http://www.fda.gov/Safety/Recalls/ EnforcementReports/default.htm), provides more information about foods that have been the subject of a Class I recall and the reasons for the recall. We will consider providing additional guidance to industry to help clarify what food hazards constitute SAHCODHA hazards under the FSVP regulations. We acknowledge that there may be concerns that the revised proposed approach to foreign supplier verification activity requirements could lead some importers to rely on verification activities that might be inadequate to provide sufficient assurances about the safety of the imported food. We believe that there are some circumstances, such as when a SAHCODHA hazard is present in a food, in which onsite auditing on an annual basis likely would be needed to ensure proper verification of suppliers. However, in some cases, including even when a SAHCODHA hazard is present, we believe it is possible that alternative supplier verification activities would provide adequate assurances of food safety. An importer who chose to conduct such an alternative activity would need to maintain documentation that the activity provides adequate assurances of safety; this documentation would be available for FDA review during any inspection of the importer. To address concerns that the revised proposal may allow too much discretion, and to assist importers in meeting the verification requirements, we anticipate that we will provide guidance to industry on the circumstances (incorporating both food and supplier risks) under which onsite auditing of foreign suppliers and/or other supplier verification approaches are appropriate for providing adequate assurances regarding the safety of the food produced by a foreign supplier. 6. Food From Farms That Are Not Covered Farms Under the Proposed Produce Safety Regulations In addition to the just-discussed revisions concerning supplier verification activities, we are proposing to include a revision regarding food from foreign suppliers that are farms but not ‘‘covered farms’’ subject to the produce safety regulations. We are making this change to reflect the different treatment of food from such farms under the proposed produce E:\FR\FM\29SEP5.SGM 29SEP5 tkelley on DSK3SPTVN1PROD with PROPOSALS5 58586 Federal Register / Vol. 79, No. 188 / Monday, September 29, 2014 / Proposed Rules safety regulations and to be consistent with the potential requirement for a supplier program in the proposed preventive controls regulations. Under § 1.506(d)(4) in the revised regulatory text, if a foreign supplier of a food is a farm that is not subject to the requirements in part 112 (the produce safety regulations) in accordance with § 112.4 regarding the food being imported, the importer would not be subject to the FSVP supplier verification activity requirements in revised § 1.506(d)(1) and (d)(2) if the importer: • Documented, at the end of each calendar year, that the food provided by the foreign supplier was not subject to part 112; and • obtained written assurance, at least every 2 years, that the foreign supplier was producing the food in compliance with the FD&C Act. These alternative verification requirements would apply to importers of food from the following: • Farms that do not grow and harvest ‘‘produce,’’ as defined in § 112.3(c) of the proposed produce safety regulations. For example, because food grains are not produce, the alternative verification requirements would apply to importers of food grain. • Farms that grow and harvest produce that is not covered by the proposed produce safety regulations in accordance with proposed § 112.1. Such ‘‘non-covered produce’’ includes produce that is rarely consumed raw, produce that is produced for personal consumption or for consumption on the farm or another farm under the same ownership, and produce that is not a RAC. • Farms that are not ‘‘covered farms’’ because they produce an average annual monetary value of produce of no more than $25,000 (see proposed § 112.4(a)). • Farms that are not covered farms because they satisfy the requirements for a qualified exemption from the proposed produce safety regulations under proposed § 112.5 (including requirements concerning direct sale to qualified end-users) and the exemption has not been withdrawn. Because FDA has determined that these farms either: (1) Should not be subject to the produce safety regulations or (2) should not be required to comply with the ‘‘standard’’ requirements applicable to covered activities conducted for covered produce, we tentatively conclude that it is appropriate to similarly not require importers of food from such farms to conduct the ‘‘standard’’ supplier verification activities. We request comment on the proposed alternative method of supplier verification of VerDate Sep<11>2014 17:13 Sep 26, 2014 Jkt 232001 obtaining written assurance of compliance with the FD&C Act by these farms. 7. Documentation of Foreign Supplier Verification Activities The proposed rule does not specify what documentation of onsite audits of foreign suppliers importers must maintain. At the public meetings on the FSVP proposed rule and in other meetings with stakeholders, we invited comment on what documentation of onsite audits importers should be required to have. We also stated that for onsite audits conducted for FSVP purposes, importers would not be required to obtain a regulatory audit report as required for audits conducted by accredited auditors/certification bodies under FDA’s proposed rule on ‘‘Accreditation of Third-Party Auditors/ Certification Bodies to Conduct Food Safety Audits and to Issue Certifications’’ (78 FR 45782, July 29, 2013). With respect to documentation of sampling and testing of an imported food, the proposed rule (§ 1.506(g)(2)(ii) under Option 1) specified a certificate of analysis (COA) containing the results of testing as an example of appropriate documentation but did not require a particular form or forms of documentation. The preamble to the proposed rule suggested certain information that might be included in a COA (78 FR 45730 at 45757). Similarly, the proposed rule (§ 1.506(g)(2)(iii) under Option 1) included records of a foreign supplier’s audit of its supplier’s hazard control activities as an example of appropriate documentation of review of a foreign supplier’s food safety records but did not require a specific form of documentation. The preamble to the proposed rule states that food safety records are records documenting that the hazard control procedures established by the supplier are being followed and are adequately controlling the hazards (78 FR 45730 at 45756). The proposed rule provided no example of appropriate documentation of other verification procedures determined by the importer to be appropriate. a. Comments Several comments state that importers should not be required to share foreign supplier audit reports with FDA. The comments state that because such reports often include confidential business information and findings of flaws in safety systems, requiring that the reports be made available to the Agency might make suppliers less likely to allow audits or result in less robust audits. Some comments suggest that PO 00000 Frm 00014 Fmt 4701 Sfmt 4702 importers be required to maintain documentation that an audit was conducted (the date of the audit and the name of the auditor) and documentation of the completion of any corrective actions in response to significant deficiencies. Regarding documentation of sampling and testing, one comment encourages us not to specify requirements for the content of COAs because this could change over time and is better left to industry to determine. b. Revisions Regarding Documentation of Supplier Verification Activities We acknowledge the concerns about requiring importers to document onsite audits of foreign suppliers with the full reports of those audits. We do not believe that importers should be required to make full audit reports available to us in an FSVP inspection. We understand that a foreign supplier might be reluctant to submit to onsite auditing if the full report of the audit would be made available to us, and we do not believe that we need to review the full audit report to determine whether an appropriate audit was conducted and any significant problems were corrected. Accordingly, we now are revising the proposed provisions regarding onsite auditing of foreign suppliers to require importers to retain documentation of the following: 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 (§ 1.506(d)(1)(i)(C) in the revised regulatory text). We tentatively conclude that this requirement would enable us to determine whether an appropriate audit of the foreign supplier was conducted and whether the importer used the audit results appropriately, while preserving the benefits of the confidentiality of the audit reports. We also are proposing to specify documentation requirements for other supplier verification activities. The revised proposal (§ 1.506(d)(1)(ii)(B) in the revised regulatory text) states that documentation of an incidence of sampling and testing (which under § 1.506(d)(1)(ii)(A) may be conducted either by the importer or the foreign supplier) must include the following: Identification of the food tested (including lot number, as appropriate), the number of samples tested, the test(s) conducted (including the analytical methods(s) used), the date(s) on which the test(s) were conducted, the results of E:\FR\FM\29SEP5.SGM 29SEP5 Federal Register / Vol. 79, No. 188 / Monday, September 29, 2014 / Proposed Rules the testing, any corrective actions taken in response to detection of hazards, and information identifying the laboratory conducting the testing. The revised proposal (§ 1.506(d)(1)(iii) in the revised regulatory text) states that documentation of each review of foreign supplier safety records must include the date(s) of review, any corrective actions taken in response to significant deficiencies identified during the review, and documentation that the review was conducted by a qualified individual. The revised proposal does not specify how importers must document other appropriate supplier verification activities that they conduct. We request comment on whether the regulations should specify the form of such documentation and, if so, what form such documentation should take. tkelley on DSK3SPTVN1PROD with PROPOSALS5 8. Independence of Qualified Individuals Conducting Verification Activities The previous proposed rule specifies that a qualified individual who conducts any of the supplier verification activities must not have a financial interest in the foreign supplier and payment of the qualified individual must not be related to the results of the activity (proposed § 1.506(g)(6) (under Option 1)). The proposal states that this requirement would not prohibit an importer or one of its employees from conducting the verification activity. In the preamble to the 2013 proposed rule, we requested comment on whether and, if so, how the regulations should specify what constitutes a financial interest (78 FR 45730 at 45759). a. Comments Many comments express support for prohibiting persons who conduct supplier verification activities from having a financial interest in the foreign supplier whose operations they are evaluating, as well as support for the ban on linking remuneration to the results of verification activity (i.e., payment for a favorable assessment). One comment states that we should specify what constitutes a financial interest to ensure that audits are not performed by persons with a financial interest in the foreign supplier, and requests that we provide a standard disclosure form regarding financial interests. b. Request for Further Comment At this time, we are not making any revisions to the proposed requirement that persons conducting supplier verification activities not have a financial interest in the foreign supplier VerDate Sep<11>2014 17:13 Sep 26, 2014 Jkt 232001 and that payment to such a person must not be related to the results of the activity they have performed. However, in the Preventive Controls supplemental document, we are requesting comment on whether the potential supplier program requirements, should they be included in the final rule, include provisions to address the independence of persons who conduct supplier verification activities. We ask in that document whether such conflict of interest requirements should be directed to a subset of persons who conduct verification activities (such as auditors) or whether they should encompass all persons who conduct verification activities. We also ask whether requirements such as those in the FSVP proposed rule would be appropriate or whether we should instead adopt different requirements, such as a requirement that persons be free of conflicts of interest that are relevant to the outcome of the verification activity conducted. In addition, we ask what should constitute a financial interest, including whether owning stock in a company should constitute a financial interest. In light of our statements in the Preventive Controls supplemental document, we renew our request for comment on the provisions in the FSVP proposed rule on the independence of qualified individuals conducting verification activities and invite comment (in the context of the FSVP regulations) on the additional conflict of interest issues raised in the Preventive Controls supplemental document. D. Definitions of Very Small Importer and Very Small Foreign Supplier The 2013 proposed rule specified certain modified FSVP requirements for very small importers and importers of food from very small foreign suppliers. Proposed § 1.500 defined a ‘‘very small importer’’ as an importer, including any subsidiary, affiliate, or subsidiaries or affiliates, collectively, of any entity of which the importer is a subsidiary or affiliate, whose average annual monetary value of sales of food during the previous 3-year period (on a rolling basis) is no more than $500,000, adjusted for inflation. Proposed § 1.500 defined a ‘‘very small foreign supplier’’ as a foreign supplier, including any subsidiary, affiliate, or subsidiaries or affiliates, collectively, of any entity of which the foreign supplier is a subsidiary or affiliate, whose average annual monetary value of sales of food during the previous 3-year period (on a rolling basis) is no more than $500,000, adjusted for inflation. PO 00000 Frm 00015 Fmt 4701 Sfmt 4702 58587 We stated in the preamble to the proposed rule that the limitation of $500,000 in annual food sales was consistent with the sales limitation in the definition of ‘‘qualified facility’’ in the Preventive Controls proposed rule and ‘‘small business’’ in the Produce Safety proposed rule. We requested comment on this proposed approach to the definitions of very small importer and very small foreign supplier (78 FR 45730 at 45744). We also requested comment on whether and, if so, how these definitions should take into account the proposed definition of ‘‘very small business’’ in the Preventive Controls proposed rule, for which we posed three alternative dollar-value ceilings: $250,000, $500,000, and $1 million. 1. Comments Several comments oppose modified requirements for very small importers and importers of food from very small foreign suppliers regardless of the sales dollar-value ceiling. Reasons specified for such opposition include the following: Congress did not exempt very small importers from the FSVP requirements; smaller operations may be more likely than larger ones to lack adequate verification or control systems because they have fewer resources; the effect of the FSVP regulations could be undermined if importers and foreign suppliers tried to manipulate their facilities or operations to avoid the ‘‘standard’’ requirements; and many small foreign suppliers would already be exempt from the preventive controls or produce safety regulations and should not benefit from an exemption from verification for their U.S. importers. Several comments support the proposed $500,000 annual food sales ceiling as a reasonable limit on eligibility for the ‘‘very small’’ modified FSVP requirements. Other comments maintain that a $1 million ceiling would better reflect the types of very small importers and foreign suppliers operating today. One comment proposes that FDA set the annual sales ceiling at $2 million to be consistent with how ‘‘small companies’’ are defined in Japan. Some comments state that other factors, either instead of, or in addition to, the monetary value of food sales, should be considered in defining very small importers and very small foreign suppliers. Some comments maintain that a more appropriate eligibility standard would be volume of food handled or sold, reflecting the fact that sales revenues vary by type of food, origin, quantity, price, and inflation rates. One comment states that a very E:\FR\FM\29SEP5.SGM 29SEP5 58588 Federal Register / Vol. 79, No. 188 / Monday, September 29, 2014 / Proposed Rules small foreign supplier should be defined as one that has fewer than 100 employees, contending that use of a monetary value ceiling would provide an unfair advantage to foreign firms because many foreign suppliers are located in countries with currencies valued lower than the U.S. dollar. Several comments state that the definitions of very small importer and very small foreign supplier should align with the definition of very small business under the preventive controls regulations. The comments state that such alignment is needed to reduce unnecessary confusion, help FDA achieve its stated goal of aligning the FSVP provisions with the supplier verification provisions in the preventive controls regulations, and ensure that the regulations are consistent with U.S. international trade obligations. tkelley on DSK3SPTVN1PROD with PROPOSALS5 2. Revisions Regarding Definitions of Very Small Importer and Very Small Foreign Supplier We are revising the proposed definitions of very small importer and very small foreign supplier by increasing the annual food sales ceiling from $500,000 to $1 million, consistent with the revised proposed definition of very small business set forth in the Preventive Controls supplemental document published elsewhere in this issue of the Federal Register. The preamble to the Preventive Controls supplemental document states that defining a very small business as a business that has less than $1 million in total annual sales of human food adjusted for inflation would simplify a food facility’s determination of whether it is a qualified facility under the preventive controls regulations because the facility would only need to calculate its total sales of human food rather than determine how much food was sold to qualified end users. The preamble to the Preventive Controls supplemental document also notes that FDA estimates that businesses with less than $1 million in total annual food sales produce less than one percent of the dollar value of food that is produced in the United States that would be covered by the preventive controls regulations in the absence of special provisions for very small businesses. The preamble further states that we are not basing the proposed definition of very small business on the number of employees or the volume of food sold because the statutory criteria for qualified facilities (of which very small businesses are a subset) focus on monetary value of sales, rather than volume of sales or number of employees. VerDate Sep<11>2014 17:13 Sep 26, 2014 Jkt 232001 To more appropriately reflect the risk to public health posed by the volume of food imported by very small importers and importers of food from very small foreign suppliers, as well as to align the proposed FSVP regulations with the proposed preventive controls regulations, we tentatively conclude that the monetary value ceiling in the definitions of very small importer and very small foreign supplier should be $1 million, adjusted for inflation. Consistency with the monetary value ceiling in the proposed definition of very small business under the proposed Preventive Controls for Human Food regulations, rather than the monetary value ceiling in the so-called Tester Amendment criteria for the definition of qualified facility (under section 418(l)(1) of the FD&C Act, is appropriate because use of the $1 million ceiling (instead of, for example, a ceiling of $250,000) means that any facility with sales below the ceiling would meet the definition of a qualified facility. We request comment on whether the revised proposed monetary value ceiling of $1 million, adjusted for inflation, for very small importers and very small foreign suppliers is appropriate, as well as on whether it is appropriate that the ceiling be the same as that specified in the definition of very small business under the preventive controls regulations. As previously noted, the produce safety proposed rule includes provisions applicable to ‘‘small businesses,’’ which are defined as having annual produce sales of no more than $500,000; the proposed rule also includes provisions for ‘‘very small businesses,’’ which are defined as having annual produce sales of no more than $250,000. In addition, farms with produce sales of no more than $25,000 would not be covered under the proposed produce safety regulations. We also note that the revised proposed regulations on preventive controls for food for animals define ‘‘very small business’’ as having annual sales of animal food of less than $2,500,000. We request comment on whether and, if so, how the FSVP regulations should take into account these definitions and provisions applicable to smaller entities under the regulations on produce safety and preventive controls for animal food. As with all other matters not specifically addressed in this supplemental notice of proposed rulemaking, we are still considering the comments that we have received concerning other aspects of the proposed modified provisions for very small importers and importers of food from very small foreign suppliers. These issues include, but are not limited to, PO 00000 Frm 00016 Fmt 4701 Sfmt 4702 whether the regulations should include any such modified provisions and, if so, what the modified requirements should be and whether the food sales to be considered for determination of eligibility should be limited to sales in or to the United States, rather than all food sales of an importer or foreign supplier. We will address comments on these issues and finalize any requirements for very small importers and importers of food from very small foreign suppliers in the FSVP final rule. E. Other Related Revisions We are making other revisions to the proposed rule to incorporate the changes that we are making regarding food and foreign supplier risk evaluations and supplier verification activities. 1. FSVP Reassessments We are revising the proposed requirement in § 1.508 of the previous proposal for importers to reassess the effectiveness of their FSVPs to be consistent with our amended proposal requiring importers to evaluate food and foreign supplier risks. Section 1.508(a)(2) in the revised regulatory text would require an importer to promptly reassess the effectiveness of its FSVP for a food when it becomes aware of new information about potential risks associated with the food or foreign supplier of the food, instead of when the importer becomes aware of information about potential food hazards, as under previous § 1.508(a)(2). Similarly, § 1.508(b) in the revised regulatory text would require that, in conducting an FSVP reassessment, an importer update its risk evaluation for a food and foreign supplier rather than, as under previous § 1.508(b), updating only the hazard analysis the importer conducted. If the reassessment led to a change in the identified risks, the importer would need to determine whether it needed to change its verification activities. 2. Records We are revising the proposed recordkeeping requirements to reflect the previously discussed proposed amendments regarding: (1) Importers whose customers are in compliance with the supplier program requirements of the preventive controls regulations, (2) importers whose customers are controlling a significant hazard in a food, and (3) documentation requirements for supplier verification activities. Under previous § 1.510(d)(2), importers would have been required to maintain for at least 2 years (after the records were created or obtained) E:\FR\FM\29SEP5.SGM 29SEP5 Federal Register / Vol. 79, No. 188 / Monday, September 29, 2014 / Proposed Rules tkelley on DSK3SPTVN1PROD with PROPOSALS5 records of certain supplier verification activities, investigations and corrective actions, FSVP reassessments, food subject to certain dietary supplement CGMP regulations, and food imported from a country with an officially recognized or equivalent food safety system (except that records of changes to FSVPs in accordance with the corrective actions or reassessment provisions would have had to be maintained until at least 2 years after their use was discontinued). Under § 1.510(d)(2) in the revised regulatory text, importers would be required to maintain for at least 2 years (after the records were created or obtained) records of, among other things, written assurances from their customers that are in compliance with the supplier program requirements of the preventive controls regulations and documentation of supplier verification activities that importers conduct. Also subject to this requirement would be written assurances from importers’ customers that the customer has established and is following procedures that will significantly minimize or prevent a hazard. With respect to records concerning the importation of dietary supplements, § 1.510(d)(2) in the revised regulatory text makes clear that this 2-year requirement would apply to written assurances of compliance with the dietary supplement CGMPs obtained from importers’ customers and documentation of supplier verification activities conducted by importers of dietary supplements (discussed in section II.E.3). 3. Dietary Supplements We are revising the proposed modified FSVP requirements for importers of dietary supplements in § 1.511 of the proposed rule to reflect previously discussed revisions to the proposed rule. We are revising previously proposed § 1.511(a) and (b) to specify that importers of dietary supplements and dietary supplement components that are subject to certain dietary supplement CGMP regulations in part 111 (21 CFR part 111) (or whose customers are subject to those regulations) would not be required to comply with revised § 1.506(a), concerning the requirement to establish and follow written procedures to ensure the use of approved suppliers (which replaces the previously proposed requirement to maintain a written list of foreign suppliers). This change is appropriate because these importers would not be required to conduct risk evaluations, which provide the basis for supplier approval. However, we request comment on whether some other VerDate Sep<11>2014 17:13 Sep 26, 2014 Jkt 232001 requirement concerning identification of foreign suppliers would be appropriate for these importers, such as a requirement, as originally proposed, to maintain a list of the foreign suppliers of the dietary supplements and dietary supplement components they import. We also are revising several of the provisions in previously proposed § 1.511(c) regarding importers of dietary supplements that will not be further processed. First, we are revising § 1.511(c)(1) to specify that although importers of these ‘‘finished’’ dietary supplements would not be required to analyze the hazards in the dietary supplements they import, they would be required to evaluate the other food safety risks set forth in § 1.505(a) in the revised regulatory text. Second, under § 1.511(c)(2) in the revised regulatory text, importers of these dietary supplements would be required to establish and follow written procedures to ensure that foods are imported only from approved suppliers (except in the limited circumstances when unapproved suppliers may be used), rather than having to maintain a list of their foreign suppliers. Third, § 1.511(c)(4) in the revised regulatory text now specifies that the purpose of supplier verification activities with respect to these dietary supplements is to provide assurances that the supplier is producing the dietary supplement in accordance with processes and procedures that provide the same level of public health protection as those required under part 111. Finally, in § 1.511(c)(5)(i) through (c)(5)(iv) in the revised regulatory text, we are proposing requirements for documentation of foreign supplier verification activities by these importers that match those discussed in section II.C.5. 4. Very Small Importers and Importers of Food From Very Small Foreign Suppliers We are revising, in § 1.512 in the revised regulatory text, the proposed modified FSVP requirements for very small importers and importers of food from very small foreign suppliers by deleting the proposed requirement to maintain a list of foreign suppliers. Consistent with our approach to requirements for very small businesses under the potential supplier program provisions in the preventive controls proposed rule, we are not proposing to require very small importers and importers of food from very small foreign suppliers to institute procedures to verify receipt of food from approved foreign suppliers. PO 00000 Frm 00017 Fmt 4701 Sfmt 4702 58589 5. Food From Countries With Officially Recognized or Equivalent Food Safety Systems We are revising, in § 1.513 in the revised regulatory text, the proposed modified FSVP requirements for importers of food from foreign suppliers in countries whose food safety system FDA has officially recognized as comparable or determined to be equivalent to that of the United States by renumbering references to sections of the regulations and by deleting the requirement to maintain a list of foreign suppliers. We tentatively conclude that, given the nature of the food that may be imported in accordance with these modified provisions (e.g., that the food is from a foreign supplier in good compliance standing with the food safety authority in a country with a comparable or equivalent food safety system), it is not necessary to apply a requirement to establish a procedure to verify receipt of food from approved suppliers to importers of such food. 6. Qualified Individuals We are revising previously proposed § 1.503, ‘‘Who must develop my FSVP and perform FSVP activities?’’, to revise a reference to proposed § 1.512, regarding the modified requirements for very small importers and importers of food from very small foreign suppliers. Previously proposed § 1.503 states that except with respect to the requirements in §§ 1.506(a), 1.509, 1.510, 1.511(c)(2), and 1.512(b)(3) and (b)(6), a qualified individual must develop their FSVP and perform each of the activities required under the subpart. Previously proposed § 1.512(b)(3) stated the proposed requirement to maintain a written list of foreign suppliers, a requirement that is being deleted by this supplemental document. Previously proposed § 1.512(b)(6) referred to records requirements, which have been renumbered as § 1.512(b)(5) in the revised regulatory text. Therefore, § 1.503 should be modified to refer only to § 1.512(b)(5). III. Preliminary Regulatory Impact Analysis As explained in the 2013 FSVP proposed rule, we performed the necessary analyses to examine the impacts of the proposed rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601–612), the Unfunded Mandates Reform Act of 1995 (Pub. L. 104–4), and the PRA (44 U.S.C. 3501– 3520). We provided a preliminary regulatory impact analysis (PRIA) of the proposed rule (see Ref. 13 of the E:\FR\FM\29SEP5.SGM 29SEP5 58590 Federal Register / Vol. 79, No. 188 / Monday, September 29, 2014 / Proposed Rules tkelley on DSK3SPTVN1PROD with PROPOSALS5 proposed rule) for public input (78 FR 45730 at 45770). We performed additional analyses to examine the impacts of the revised proposed provisions described in this Federal Register document under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act, the Unfunded Mandates Reform Act of 1995, and the PRA. We present our additional analyses, including the total estimated costs and benefits of the FSVP proposed rule as revised, in our supplemental PRIA for this proposed rule (Ref. 3). We seek comment on our additional analyses. IV. Paperwork Reduction Act of 1995 This proposed rule contains information collection requirements that are subject to review by the OMB under the PRA (44 U.S.C. 3501–3520). A description of these provisions is given in the Description section with an estimate of the annual reporting, recordkeeping, and third-party disclosure burden. Included in the estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing each collection of information. FDA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility; (2) the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Title: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals. Description: FDA is revising its proposed regulations on FSVPs for food for humans and animals. The proposed regulations are intended to help ensure that food imported into the United States is produced in compliance with processes and procedures, including reasonably appropriate risk-based preventive controls, that provide the same level of public health protection as the processes and procedures required for production of food in compliance with section 418 or 419 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 350g or 350h), if either VerDate Sep<11>2014 17:13 Sep 26, 2014 Jkt 232001 is applicable, and in compliance with sections 402 and 403(w) of the FD&C Act (21 U.S.C. 342 and 343(w)). The revisions to the proposed rule include the following: (1) Specifying a revised approach to proposed requirements for supplier verification activities (the previous proposal contained two alternative approaches); (2) stating that importers who are in compliance with the potential supplier program provisions of the preventive controls regulations would be deemed in compliance with most of the FSVP requirements; (3) deleting the proposed requirement that importers conduct a food and foreign supplier compliance status review but adding a proposed requirement that importers consider, in addition to the hazards in the food they import, certain factors related to supplier risks; (4) proposing to require importers to follow written procedures for ensuring the use of suppliers that they have approved based on their evaluation of supplier risks, rather than require importers to maintain a list of suppliers; (5) proposing to require importers of food from farms not subject to the produce safety regulations to obtain written assurance of compliance from their suppliers rather than conduct standard verification activities; and (6) revising the definitions of very small importer and very small foreign supplier by increasing the annual food sales limit from $500,000 to $1 million. Description of Respondents: Generally, persons who import food into the United States. We estimate that there are approximately 56,800 persons who meet the definition of importer set forth in the proposed rule. However, the proposed rule would exempt from the FSVP requirements the importation of certain foods, including certain juice and seafood products, food for research or evaluation (exempt but subject to a third-party disclosure requirement), food for personal consumption, certain alcoholic beverages, food that is transshipped, and food that is imported for further processing and future export. The proposed rule also would specify that importers who are in compliance with any supplier program provisions that the preventive controls final regulations may include would be deemed in compliance with most of the FSVP requirements. Certain exceptions to the standard FSVP requirements would apply to importers of food for which the importer or its customer controls the hazards and to importers of food from farms not subject to the produce safety regulations. In addition, the proposed rule would establish modified FSVP requirements for importers of dietary PO 00000 Frm 00018 Fmt 4701 Sfmt 4702 supplements, very small importers, importers of food from very small foreign suppliers, and importers of food from suppliers in countries whose food safety systems FDA has officially recognized as comparable or determined to be equivalent to that of the United States. The information collection estimate for the FSVP proposed rule has decreased due to revisions to the proposed rule requirements. The information collection burden was previously estimated to be 3,303,988 hours; the revised estimate is 2,917,603 hours, a reduction of 386,385 hours. For more information on the original calculation of the information burden estimate, refer to the PRA for the previous proposed rule (Docket No. FDA–2011–N–0143). Information Collection Burden Estimate Supplemental Notice of Proposed Rulemaking Burden FDA estimates the burden for this information collection as follows: A. Reporting Burden 1. Exemption for Food for Research or Evaluation Under proposed § 1.501(c), the FSVP regulations would not apply to food that is imported for research or evaluation purposes, provided that: • The food is not intended for retail sale and is not sold or distributed to the public. • The food is labeled with the statement ‘‘Food for research or evaluation use.’’ • When filing entry for the food with U.S. Customs and Border Protection (CBP), the customs broker or filer for the food provides an electronic declaration that the food will be used for research or evaluation purposes and will not be sold or distributed to the public. As shown in table 1, we estimate that annually there will be 36,360 persons for whom a declaration that a food will be used for research or evaluation purposes will be submitted, and that about 40 declarations will be submitted for each such person annually. We further estimate that submission of this declaration should take approximately 0.083 hours, resulting in a total annual burden of 120,715 hours. There is no change from the previous estimated burden. 2. Importer Identification at Entry Proposed § 1.509(c) would require importers to ensure that, for each line entry of food product offered for importation into the United States, its name and Dun and Bradstreet Data E:\FR\FM\29SEP5.SGM 29SEP5 Federal Register / Vol. 79, No. 188 / Monday, September 29, 2014 / Proposed Rules Universal Numbering System (DUNS) number is provided electronically when filing entry with CBP. As shown in table 1, we estimate that each of the estimated 56,800 importers would need to ensure that this information is provided for an average of 157 line entries each year. We further estimate that each such submission would require 0.02 hours, resulting in a total annual burden of 58591 178,352 hours. There is no change from the previous estimated burden. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents 21 CFR Section Number of responses per respondent Total annual responses Average burden per response Total hours Exemption for food for research 1.501(c) ................ DUNS number for filing with CBP 1.509(c), 1.511(c), 1.512(b)(2). 36,360 56,800 40 157 1,454,400 8,917,600 0.083 (5 minutes) ...... 0.02 (1.2 minutes) ..... 120,715 178,352 Total .................................................................. ........................ ........................ ........................ .................................... 299,067 1 There are no capital costs or operating and maintenance costs associated with this collection of information. B. Recordkeeping Burden tkelley on DSK3SPTVN1PROD with PROPOSALS5 1. Documentation of Production of LowAcid Canned Foods in Accordance With 21 CFR Part 113 Proposed § 1.502(b) would require importers of thermally processed lowacid canned foods (LACF) packaged in hermetically sealed containers to verify and document that, with respect to microbiological hazards that are controlled under part 113 (21 CFR part 113), the food was produced in accordance with those regulations, and for all matters not controlled under part 113, to have an FSVP as specified in § 1.502(a). As shown in table 2, we estimate that there are 2,443 importers of LACF importing an estimated 4 LACF products annually. We further estimate that it would take each LACF importer 1 hour to document that a food was produced in accordance with part 113. This results in a total annual burden of 9,772 hours. There is no change from the previous estimated burden. 2. Hazard Analysis Revised proposed § 1.504(a) would require importers, for each food they import or offer for import, to have a written hazard analysis. We estimate that 13,389 importers would need to spend an average of 10.5 hours each determining and documenting hazard analyses for imported foods, resulting in an estimated burden of 140,584.5 hours (46,862 hours annualized). Revised proposed § 1.504(d) would permit importers to identify the hazards that are reasonably likely to occur with a food by reviewing and evaluating the hazard analysis conducted by the foreign supplier of the food. If the importer selects this approach to hazard analysis it must document the determination it makes based on its review and evaluation of the foreign supplier’s hazard analysis. As shown in table 2, we estimate that 13,389 VerDate Sep<11>2014 17:13 Sep 26, 2014 Jkt 232001 importers would take this approach to hazard analysis for about 7 products each, and that evaluating the supplier’s hazard analysis and documenting each evaluation would require about 1 hour on average. This results in a total burden of 93,723 hours (30,929 hours annualized). 3. Risk Evaluation Revised proposed § 1.505(a)(2) would require importers to document their evaluation of food and supplier risks. As shown in table 2, we estimate that it will take 12 hours for each of an estimated 13,389 importers to conduct and document their risk evaluation and approval of suppliers, resulting in a total burden of 160,668 hours (53,556 hours annualized). In addition, revised proposed § 1.505(b) requires that the importer reevaluate risk factors associated with suppliers when the importer becomes aware of new information. Recognizing that some importers may choose to spend more time less often, we estimate it would take about 15 minutes per day to maintain and follow these procedures by reviewing information regarding hazards and suppliers. This results in a burden of 1,221,746 hours annually. 4. Foreign Supplier Verification and Related Activities Under revised proposed § 1.506(a), importers must establish and follow adequate written procedures to ensure that they import foods only from foreign suppliers that they have approved based on the risk evaluation they conduct under § 1.505 or, when necessary and appropriate, on a temporary basis from unapproved foreign suppliers whose foods importers subject to adequate verification activities before distributing, and document the use of those procedures. As shown in table 2, we estimate that it would take each of 13,389 importers 8 hours to establish PO 00000 Frm 00019 Fmt 4701 Sfmt 4702 procedures resulting in a burden of 107,112 hours (35,749 hours annualized) and 4 hours annually to document the use of such procedures resulting in an annual burden of 53,556 hours for a grand total of 89,305 hours annually. Under revised proposed § 1.506(b), importers must establish and follow adequate written procedures for conducting foreign supplier verification activities. As shown in table 2, we estimate that it would take each of 13,389 importers 2 hours to establish procedures for about 4 hazards/products per importer resulting in a total annual burden of 107,112 hours (35,883 hours annualized). Revised proposed § 1.506(d) would require importers to determine and document which supplier verification activities are appropriate in order to provide adequate assurances that the 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 or 419, as applicable, and is producing the food in compliance with sections 402 and 403(w) of the FD&C Act. Under revised proposed § 1.506(d)(1)(i), an importer may conduct (and document) or obtain documentation of a periodic onsite audit of the foreign supplier. As shown in table 2, we estimate that 2,369 such audits would be conducted or documentation obtained for, with each audit requiring an average of 14 hours each, resulting in a total annual burden of 33,166 hours. Under revised proposed § 1.506(d)(1)(ii), an importer may conduct (and document) or obtain documentation from a foreign supplier of lot-by-lot or periodic sampling and testing of a food for a hazard. As shown in table 2, we estimate that 11,396 importers each year would determine that this approach to verification is E:\FR\FM\29SEP5.SGM 29SEP5 tkelley on DSK3SPTVN1PROD with PROPOSALS5 58592 Federal Register / Vol. 79, No. 188 / Monday, September 29, 2014 / Proposed Rules appropriate an average of 5 times per year. We further estimate that each incidence of sampling and testing and corresponding documentation will require 4 hours. This results in a total annual burden of 227,920 hours. Under revised proposed § 1.506(d)(1)(iii), an importer may conduct (and document) or obtain documentation of a review of its foreign supplier’s food safety records to verify control of a hazard. As shown in table 2, we estimate that 11,396 importers each year would determine that this approach to verification is appropriate an average of 5 times per year. We further estimate that documentation of food safety record review would require 1.6 hours, resulting in a total annual burden of 91,168 hours. Under revised proposed § 1.506(d)(1)(iv), an importer may use a different verification procedure that it has established as being appropriate based on the risk associated with the food and foreign supplier; the importer must document such use. We have not identified any alternative verification procedure nor included such costs in the PRIA; therefore, we do not identify any associated burden here for revised proposed § 1.506(d)(1)(iv). Revised proposed § 1.506(d)(4) requires that if a foreign supplier of a food is a farm that is not subject to the requirements in part 112, the importer need only to: (1) Document, at the end of each calendar year, that the food from the foreign supplier is not subject to the produce safety regulations and (2) obtain written assurance, at least every 2 years, that the foreign supplier is producing the food in compliance with the FD&C Act. We estimate that these requirements would affect 22,333 importers annually and that each importer would need to conduct this documentation for 8 such suppliers each year, with documentation of each determination requiring, on average, 0.75 hours. This would result in a total annual burden of 133,998 hours. Revised proposed § 1.506(d)(5) would allow an importer, instead of conducting an onsite audit, to rely on the results of an inspection of the foreign supplier by FDA or the food safety authority of a country whose food safety system FDA has officially recognized as comparable or has determined to be equivalent to that of the United States, provided that the inspection was conducted within 1 year of the date that the onsite audit would have been required to be conducted. We do not estimate a PRA burden associated with this option because FDA has only officially recognized one country’s food safety system to date and VerDate Sep<11>2014 17:13 Sep 26, 2014 Jkt 232001 the Agency inspects only a small percentage of foreign food facilities each year. 5. Review of Complaints, Investigations, and Corrective Actions Proposed § 1.507(b) would require an importer, if it became aware that an article of food that it imported was adulterated or misbranded, to promptly investigate the cause or causes of such adulteration or misbranding and to document any such investigation. As shown in table 2, we estimate that 10,658 importers would need to conduct 1 such investigation each year, and that conducting and documenting an investigation will require 14 hours. This would result in a total annual burden of 149,212 hours. There is no change from the previous estimated burden. Revised proposed § 1.507(c) would require an importer to take corrective actions if it determines that one of its foreign suppliers of a food does not produce the food in compliance with the requirements of section 418 or 419 of the FD&C Act, if either is applicable, or produces food that is adulterated under section 402 or misbranded under section 403(w) of the FD&C Act. Such corrective actions will depend on the circumstances but could include discontinuing use of the foreign supplier until the cause or causes of noncompliance, adulteration, or misbranding have been adequately addressed. In the PRIA we postulated that most importers probably already take some type of corrective actions if they determine that a food they import is not in compliance with appropriate regulations and that they probably document those corrective actions. Therefore, because we assume that most importers already take these types of corrective actions, we did not estimate the cost of additional corrective actions in the PRIA nor calculate a burden associated with corrective actions in the PRA. Revised proposed § 1.507(d) would require an importer, if it determines by means other than its verification activities conducted under § 1.506 or § 1.511(c) or its FSVP reassessment conducted under § 1.508, that one of its foreign suppliers does not produce food in compliance with the requirements of section 418 or 419 of the FD&C Act, if either is applicable, or produces food that is adulterated under section 402 or misbranded under section 403(w) of the FD&C Act, to promptly investigate to determine whether the importer’s FSVP is adequate and, when appropriate, to modify the FSVP. This provision also would require importers to document any such investigations and FSVP PO 00000 Frm 00020 Fmt 4701 Sfmt 4702 changes. As shown in table 2, we estimate that, on average, 10,658 importers will need to conduct an investigation once a year to determine the adequacy of their FSVP in accordance with proposed § 1.507(d) and that conducting and documenting the investigation will require 5 hours. This would result in a total annual burden of 53,290 hours. There is no change from the previous estimated burden. 6. FSVP Reassessment Revised proposed § 1.508(b) would require an importer to document each reassessment of its FSVP that it conducts under § 1.508 and any resulting changes to the FSVP. Reassessment would be required every 3 years or more frequently if an importer becomes aware of new information about potential risks associated with a food or foreign supplier. We did not estimate a cost for reassessing an importer’s FSVP under this requirement in the PRIA because we have already incorporated the costs of reassessment into the costs for maintaining the various elements of the FSVP in other provisions. Therefore we do not calculate an associated PRA burden here. 7. Food Subject to Certain Dietary Supplement CGMP Regulations Revised proposed § 1.511 sets forth modified FSVP requirements for food that is subject to certain dietary supplement CGMP regulations. Under revised proposed § 1.511(a), importers who are required to establish specifications under § 111.70(b), (d), or (f) (21 CFR 111.70(b), (d), or (f)) with respect to a food, and are in compliance with the requirements of part 111 applicable to determining whether those specifications are met, must comply with the requirements in proposed §§ 1.509 and 1.510, but are not required to comply with the requirements of proposed §§ 1.502 through 1.508. These importers are included in the estimated reporting burden for proposed § 1.509(c). Under revised proposed § 1.511(b), if an importer’s customer is required to establish specifications under § 111.70(b), (d), or (f) with respect to a food, the customer is in compliance with the requirements of part 111 applicable to determining whether those specifications are met, and the importer annually obtains from its customer written assurance that the customer is in compliance with those requirements, then for that food the importer must comply with the requirements in §§ 1.509 and 1.510, but is not required E:\FR\FM\29SEP5.SGM 29SEP5 tkelley on DSK3SPTVN1PROD with PROPOSALS5 Federal Register / Vol. 79, No. 188 / Monday, September 29, 2014 / Proposed Rules to comply with the requirements of §§ 1.502 through 1.508. As shown in table 2, we estimate that 5,574 importers would need to obtain written assurance from an average of 6 customers in accordance with revised § 1.511(b) and that documentation of each assurance would take 2.25 hours, resulting in a total annual burden of 75,249 hours. In addition, these importers are included in the estimated annual reporting burden for proposed § 1.509(c). Under revised proposed § 1.511(c), importers of ‘‘finished’’ dietary supplements (i.e., packaged and labeled dietary supplements that are not subject to further processing) would be subject to different FSVP requirements. Revised proposed § 1.511(c)(2) would require importers of finished dietary supplements to establish and follow written procedures to ensure that food is imported only from foreign suppliers that have been approved for use based on the risk evaluation conducted under § 1.505. This burden to importers of ‘‘finished’’ dietary supplements is captured in the burden calculated for proposed § 1.506(a). Proposed § 1.511(c)(3) would require importers of finished dietary supplements to establish and follow procedures for conducting foreign supplier verification activities. This burden is included in the burden of revised proposed § 1.506(b). Revised proposed § 1.511(c)(5) would require importers of finished dietary supplements to determine and document which appropriate verification activities should be conducted, and the frequency with which they should be conducted. As shown in table 2, we estimate that this provision would affect 1,822 importers annually and that each importer would need to make and document about 2 determinations (regarding both the appropriate verification activity and its frequency) each year, with making and documenting of each determination requiring 2.5 hours. This would result in a total annual burden of 9,110 hours. There is no change from the previous estimated burden. For each ‘‘finished’’ dietary supplement imported, the importer would need to conduct one or more of the verification activities listed in proposed § 1.511(c)(5)(i) through (c)(5)(iv) before using or distributing the dietary supplement and periodically thereafter. The estimates associated with these activities are included in the burdens presented in table 2 for § 1.506(d)(1)(i) through (d)(1)(iv), respectively. Revised proposed § 1.511(c) also would require importers of finished VerDate Sep<11>2014 17:13 Sep 26, 2014 Jkt 232001 dietary supplements to conduct risk evaluations, conduct investigations and corrective actions, reassess the effectiveness of their FSVP, and ensure that information identifying them as the importer is provided at entry. These importers have been included in the estimated recordkeeping and reporting burdens for these activities under proposed §§ 1.505, 1.507(b), 1.508(b), and 1.509(c), respectively. We do not estimate any specific burden associated with corrective actions (§ 1.507(c)) as previously discussed. 8. Food Imported by Very Small Importers and From Very Small Foreign Suppliers Revised proposed § 1.512 sets forth modified proposed FSVP requirements for very small importers (i.e., importers with annual food sales of not more than $1 million) and food from very small foreign suppliers (i.e., foreign suppliers with annual food sales of not more than $1 million). Under proposed § 1.512(b)(1), if a very small importer or an importer of food from a very small foreign supplier chooses to comply with the requirements in § 1.512, the importer would be required to document, at the end of each calendar year, that it meets the definition of very small importer in § 1.500 or that the foreign supplier meets the definition of very small foreign supplier in § 1.500, whichever is applicable. As shown in table 2, we estimate that 56,800 importers would need to document eligibility each year (either that they are a very small importer or that they are obtaining food from a very small foreign supplier) and that such documentation would require 1 hour. While very small importers would only need to document this once per year, importers importing from very small suppliers may need to do it more than once, so we use an average of 1.79 records per importer, resulting in a total annual burden of 101,770 hours. Under revised proposed § 1.512(b)(3), each very small importer or importer of food from a very small foreign supplier would need to obtain written assurance, before importing the food and at least every 2 years thereafter, that its foreign supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection as that required under section 418 or 419 of the FD&C Act, if either is applicable, and is producing the food in compliance with sections 402 and 403(w) of the FD&C Act. As shown in table 2, we estimate that 56,800 importers would need to obtain an average of 2 such written assurances each year and that PO 00000 Frm 00021 Fmt 4701 Sfmt 4702 58593 documentation of each assurance would require 2.25 hours, resulting in a total annual burden of 255,600 hours. Revised proposed § 1.512(b)(4) also would require very small importers and importers of food from very small foreign suppliers to document corrective actions; as previously stated, we do not estimate any specific burden associated with corrective actions. 9. Food Imported From a Country With an Officially Recognized or Equivalent Food Safety System Revised proposed § 1.513 would establish modified FSVP requirements for importers of food from foreign suppliers in countries whose food safety systems FDA has officially recognized as comparable or determined to be equivalent to that of the United States. If such importers met certain conditions or requirements, they would not be required to comply with the requirements in proposed §§ 1.503 through 1.508, but they would be required to comply with §§ 1.509 and 1.510. Proposed § 1.513(b)(1) would require an importer, before importing a food from the foreign supplier and annually thereafter, to document that the foreign supplier is in, and under the regulatory oversight of, a country whose food safety system FDA has officially recognized as comparable or determined to be equivalent and that the food is within the scope of FDA’s official recognition or equivalency determination regarding the food safety authority of the country in which the foreign supplier is located. Proposed § 1.513(b)(2) would require an importer, before importing a food from the foreign supplier, to determine and document whether the foreign supplier of the food is in good compliance standing, as defined in proposed § 1.500, with the food safety authority of the country in which the foreign supplier is located. The importer would be required to continue to monitor whether the foreign supplier is in good compliance standing and promptly review any information obtained. If the information indicated that food safety hazards associated with the food were not being adequately controlled, the importer would be required to take prompt corrective action and to document any such action. FDA has officially recognized New Zealand as having a food safety system that is comparable to that of the United States; we have not yet determined any food safety systems to be equivalent. Because we have only recently entered into a systems recognition arrangement with New Zealand, we have not been E:\FR\FM\29SEP5.SGM 29SEP5 58594 Federal Register / Vol. 79, No. 188 / Monday, September 29, 2014 / Proposed Rules able to assess the effect of the arrangement on the importation of food from that country. Therefore, we have not included estimates for the recordkeeping burdens associated with proposed § 1.513. There is no change from the previous estimated burden. TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of recordkeepers 21 CFR section Controls for LACF 1.502(b) ................. Determine and document hazards 1.504(a) ............................................ Review hazard analysis 1.504(d) ........ Risk evaluation 1.505(a) and (b), 1.511(c)(2) ........................................ Reevaluation of risks 1.505(c) ............. Written procedures for use of approved foreign suppliers 1.506(a), 1.511(c)(2) ........................................ Written procedures for conducting verification activities 1.506(b), 1.511(c)(3) ........................................ Conduct/review audits 1.506(d)(1)(i), 1.511(c)(5)(i) ..................................... Conduct periodic sampling/testing 1.506(d)(1)(ii), 1.511(c)(5)(ii) ............ Review records 1.506(d)(1)(iii), 1.511(c)(5)(iii) ................................... Written assurances from foreign suppliers 1.506(d)(4) .............................. Investigate adulteration or misbranding 1.507(b), 1.511(c)(1) ........................ Investigate and determine FSVP adequacy 1.507(d), 1.511(c)(1) .............. Written assurances for food produced under dietary supplement CGMPs 1.511(b) ............................................ Determine and document verification activities for importers of dietary supplements 1.511(c)(5) .................. Document very small importer/very small foreign supplier status 1.512(b)(1) ........................................ Written assurances associated with very small importer/very small foreign supplier 1.512(b)(3) .................. Total .............................................. tkelley on DSK3SPTVN1PROD with PROPOSALS5 1 There Number of records per recordkeeper Total annual records 2,443 4 9,772 13,389 13,389 1 7 13,389 93,723 13,389 13,389 1 365 13,389 Average burden per recordkeeping (hours) 1 Total hours Total operating and maintenance costs 9,772 ........................ 3.5 0.33 46,862 30,929 ........................ ........................ 13,389 4,886,985 4 0.25 53,556 1,221,746 ........................ ........................ 1 13,389 6.67 89,305 ........................ 13,389 4 53,556 0.67 35,883 ........................ 2,369 1 2,369 14 33,166 $1,480,625 11,396 5 56,980 4 227,920 $75,954,340 11,396 5 56,890 1.6 91,168 ........................ 22,333 8 178,664 0.75 133,998 ........................ 10,658 1 10,658 14 149,212 $6,661,250 10,658 1 10,658 5 53,290 ........................ 5,574 6 33,444 2.25 75,249 ........................ 1,822 2 3,644 2.50 9,110 ........................ 56,800 1.79 101,770 1 101,770 ........................ 56,800 2 113,600 2.25 255,600 ........................ ........................ .......................... 2,618,536 $84,096,215 ........................ .......................... are no capital costs associated with this collection of information. In compliance with the PRA (44 U.S.C. 3407(d)), the Agency has submitted the information collection provisions of this proposed rule to OMB for review. These requirements will not be effective until FDA obtains OMB approval. Interested persons are requested to send comments regarding information collection by December 15, 2014 to the Office of Information and Regulatory Affairs, OMB. To ensure that comments on information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–6974, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the title, ‘‘Foreign Supplier Verification VerDate Sep<11>2014 17:13 Sep 26, 2014 Jkt 232001 Programs for Importers of Food for Humans and Animals.’’ V. Analysis of Environmental Impact We did not prepare an environmental assessment or an environmental impact statement for the 2013 FSVP proposed rule because we determined under 21 CFR 25.30(j) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Because we have reached the same determination with respect to these revisions to the proposed rule included in this supplemental notice of proposed rulemaking, neither an environmental assessment nor an environmental impact statement is required for this document. PO 00000 Frm 00022 Fmt 4701 Sfmt 4702 VI. Comments Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http:// www.regulations.gov. VII. References The following references have been placed on display in the Division of Dockets Management (see ADDRESSES) E:\FR\FM\29SEP5.SGM 29SEP5 Federal Register / Vol. 79, No. 188 / Monday, September 29, 2014 / Proposed Rules and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. These references are also available electronically at http:// regulations.gov. We have verified the Web site addresses in this section, but we are not responsible for any subsequent changes to Web sites after this document publishes in the Federal Register. 1. FDA, Statement from FDA Deputy Commissioner for Foods and Veterinary Medicine, Michael Taylor, on Key Provisions of the Proposed FSMA Rules Affecting Farmers, December 19, 2013 (http://www.fda.gov/Food/Guidance Regulation/FSMA/ ucm379397.htm?source=govdelivery& utm_medium=email&utm_ source=govdelivery). 2. FDA, Proposed 21 Code of Federal Regulations, Part 1, Subpart L—Foreign Supplier Verification Programs for Food Importers (indicating revisions proposed in supplemental notice of proposed rulemaking), 2014. 3. FDA, ‘‘Supplemental Preliminary Regulatory Impact Analysis,’’ Docket Nos. FDA–2011–N–0143, Foreign Supplier Verification Programs for Importers of Food for Humans and Animals, and FDA–2011–N–0146, Accreditation of Third-Party Auditors/ Certification Bodies to Conduct Food Safety Audits and to Issue Certifications, 2014 (http://www.fda.gov/AboutFDA/ ReportsManualsForms/Reports/ EconomicAnalyses/default.htm). List of Subjects in 21 CFR Part 1 Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling, Reporting and recordkeeping requirements. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, it is proposed that 21 CFR part 1, as proposed to be added on July 29, 2013 (78 FR 45730), be amended as follows: PART 1—GENERAL ENFORCEMENT REGULATIONS 1. The authority citation for 21 CFR part 1 is revised to read as follows: ■ Authority: 15 U.S.C. 1453, 1454, 1455; 19 U.S.C. 1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 343, 350c, 350d, 352, 355, 360b, 362, 371, 374, 381, 382, 384a, 393; 42 U.S.C. 216, 241, 243, 262, 264. tkelley on DSK3SPTVN1PROD with PROPOSALS5 Subpart L—[Amended] 2. In § 1.500, remove the definition for ‘‘Hazard reasonably likely to occur,’’ add in alphabetical order definitions for ‘‘Environmental pathogen,’’ ‘‘Facility,’’ ‘‘Known or reasonably foreseeable hazard,’’ ‘‘Pathogen,’’ ‘‘Qualified auditor,’’ and ‘‘Significant hazard,’’ and revise the definitions for ‘‘Hazard,’’ ■ VerDate Sep<11>2014 17:13 Sep 26, 2014 Jkt 232001 ‘‘Very small foreign supplier,’’ and ‘‘Very small importer’’ to read as follows: § 1.500 What definitions apply to this subpart? * * * * * Environmental pathogen means a pathogen that is capable of surviving and persisting within the manufacturing, processing, packing, or holding environment such that food may be contaminated and may result in foodborne illness if that food is consumed without treatment to significantly minimize or prevent the environmental pathogen. Environmental pathogen does not include the spores of pathogenic sporeformers. Facility means a domestic facility or a foreign facility that is required to register under section 415 of the Federal Food, Drug, and Cosmetic Act, in accordance with the requirements of subpart H of this part. * * * * * Hazard means any biological, chemical (including radiological), or physical agent that is reasonably likely to cause illness or injury in the absence of its control. * * * * * Known or reasonably foreseeable hazard means a potential biological, chemical (including radiological), or physical hazard that is known to be, or has the potential to be, associated with a food or the facility in which it is manufactured/processed. * * * * * Pathogen means a microorganism of public health significance. Qualified auditor means a person who is a qualified individual as defined in this section and has technical expertise obtained by a combination of training and experience appropriate to perform the auditing function. A foreign government employee could be a qualified auditor. * * * * * Significant hazard means a known or reasonably foreseeable hazard 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 and corrective actions, verification, and records) as appropriate to the food, the facility, and the control. * * * * * Very small foreign supplier means a foreign supplier, including any subsidiary, affiliate, or subsidiaries or PO 00000 Frm 00023 Fmt 4701 Sfmt 4702 58595 affiliates, collectively, of any entity of which the foreign supplier is a subsidiary or affiliate, whose average annual monetary value of sales of food during the previous 3-year period (on a rolling basis) is no more than $1 million, adjusted for inflation. Very small importer means an importer, including any subsidiary, affiliate, or subsidiaries or affiliates, collectively, of any entity of which the importer is a subsidiary or affiliate, whose average annual monetary value of sales of food during the previous 3-year period (on a rolling basis) is no more than $1 million, adjusted for inflation. * * * * * ■ 3. In § 1.502, add paragraphs (c) and (d) to read as follows: § 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. (d) Importers whose customer is subject to section 418 of the Federal Food, Drug, and Cosmetic Act. If your customer is 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 annually obtain from your customer written assurance that it is 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 and 1.510. ■ 4. Revise § 1.503 to read as follows: § 1.503 Who must develop my FSVP and perform FSVP activities? Except with respect to the requirements in §§ 1.506(a), 1.509, 1.510, 1.511(c)(2), and 1.512(b)(5), a qualified individual must develop your FSVP and perform each of the activities required under this subpart. ■ 5. Revise § 1.504 to read as follows: § 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 food you import to determine whether there are any significant E:\FR\FM\29SEP5.SGM 29SEP5 tkelley on DSK3SPTVN1PROD with PROPOSALS5 58596 Federal Register / Vol. 79, No. 188 / Monday, September 29, 2014 / Proposed Rules hazards. Your hazard analysis must be written. (b) Hazard identification. (1) Your analysis of the known or reasonably foreseeable hazards in each food must include the following types of hazards: (i) Biological hazards, including microbiological hazards such as parasites, environmental pathogens, and other pathogens; (ii) Chemical hazards, including radiological hazards, pesticide and drug residues, natural toxins, decomposition, unapproved food or color additives, and food allergens; and (iii) Physical hazards. (2) Your analysis must include hazards that may be present in a food for any of the following reasons: (i) The hazard occurs naturally; (ii) The hazard may be unintentionally introduced; (iii) The hazard may be intentionally introduced for purposes of economic gain. (c) Hazard evaluation. (1) Your hazard analysis must include an evaluation of the hazards identified in paragraph (b) of this section to assess the probability that the hazard will occur in the absence of controls and the severity of the illness or injury if the hazard were to occur. (2) The hazard evaluation required by paragraph (c)(1) of this section must include an evaluation of environmental pathogens whenever a ready-to-eat food is exposed to the environment before packaging and the packaged food does not receive a treatment that would significantly minimize the pathogen. (3) Your hazard evaluation must consider the effect of the following on the safety of the finished food for the intended consumer: (i) The formulation of the food; (ii) The condition, function, and design of the foreign supplier’s establishment and equipment; (iii) Raw materials and ingredients; (iv) Transportation practices; (v) Harvesting, raising, manufacturing, processing, and packing procedures; (vi) Packaging and labeling activities; (vii) Storage and distribution; (viii) Intended or reasonably foreseeable use; (ix) Sanitation, including employee hygiene; and (x) Any other relevant factors. (d) Review of the foreign supplier’s hazard analysis. If your foreign supplier has analyzed the known or reasonably foreseeable hazards for the food to determine whether there are any significant hazards, you may meet your requirement to determine whether there are any significant hazards in a food by reviewing and assessing the analysis conducted by the foreign supplier. VerDate Sep<11>2014 17:13 Sep 26, 2014 Jkt 232001 (e) Microbiological hazards in raw agricultural commodities that are fruits or vegetables. If you are importing a raw agricultural commodity that is a fruit or vegetable, you are not required to determine whether there are any significant microbiological hazards in such food. (f) No significant hazards. If you evaluate the known and reasonably foreseeable hazards in a food and determine that there are no significant hazards, 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. This paragraph (f) does not apply if the food is a raw agricultural commodity that is a fruit or vegetable and that is subject to part 112 of this chapter. (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. ■ 6. Revise § 1.505 to read as follows: § 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 that you must conduct, you must consider the following: (i) The hazard analysis that you conduct in accordance with § 1.504, including the nature of the hazard. (ii) The entity that will be applying controls for the hazards analyzed under § 1.504, such as the foreign supplier or the foreign supplier’s raw material or ingredient supplier. (iii) The foreign supplier’s procedures, processes, and practices related to the safety of the food. (iv) Applicable FDA food safety regulations and information regarding the foreign supplier’s compliance with those regulations, including whether the foreign supplier is the subject of an FDA warning letter or import alert. PO 00000 Frm 00024 Fmt 4701 Sfmt 4702 (v) The foreign supplier’s food safety performance history, including results from testing foods for hazards, audit results relating to the safety of the food, and the supplier’s record of correcting problems. (vi) Any other factors as appropriate and necessary, such as storage and transportation practices. (2) You must document your evaluation of risks. (b) Reevaluation of risk factors. You must promptly reevaluate the risk factors specified in paragraph (a)(1) of this section associated with a food or foreign supplier when you become aware of new information about these factors. If you determine that it is appropriate to continue to import the food from the foreign supplier, you must document the reevaluation and your determination. ■ 7. Revise § 1.506 to read as follows: § 1.506 What foreign supplier verification and related activities must I conduct? (a) Use of approved foreign suppliers. You must establish and follow written procedures 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. (b) Foreign supplier verification procedures. You must establish and follow adequate written procedures for conducting foreign supplier verification activities with respect to the foods you import. (c) Purpose of supplier verification. Your foreign supplier verification activities must provide adequate assurances that the foreign supplier produces 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 or 419, if either is applicable, and is producing the food in compliance with sections 402 and 403(w) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350g, 350h, 342, and 343(w)). (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 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 E:\FR\FM\29SEP5.SGM 29SEP5 tkelley on DSK3SPTVN1PROD with PROPOSALS5 Federal Register / Vol. 79, No. 188 / Monday, September 29, 2014 / Proposed Rules document which verification 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. (i) Onsite audit of the foreign supplier. (A) An onsite audit of a supplier must be performed by a qualified auditor. (B) If the food is subject to one or more FDA food safety regulations, an onsite audit of the foreign supplier must consider such regulations and include a review of the supplier’s written food safety plan for the food, if any, including its implementation. (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. (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. (B) You must retain documentation of each sampling and testing of a food, including identification of the food tested (including lot number, as appropriate), the number of samples tested, the test(s) conducted (including the analytical methods(s) used), the date(s) on which the test(s) were conducted, the results of the testing, any corrective actions taken in response to detection of hazards, and information identifying the laboratory conducting the testing. (iii) Review of the foreign supplier’s relevant food safety records. You must retain documentation of each record review, including the date(s) of review, any corrective actions taken in response to significant deficiencies identified during the review, and documentation that the review was conducted by a qualified individual. (iv) Other appropriate activity. You may conduct other supplier verification activities that are appropriate based on the risk associated with the food and the foreign supplier. You must document each performance of such verification activity. (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 or 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 VerDate Sep<11>2014 17:13 Sep 26, 2014 Jkt 232001 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. (3) Based on the risk evaluation you conduct, it might be necessary, under paragraph (d)(1) or (2) of this section, to conduct more than one supplier verification activity to address an individual hazard or risk factor or multiple hazards or risk factors. (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. (5) Substitution of inspection by FDA or an officially recognized or equivalent food safety authority. (i) Instead of an onsite audit conducted under paragraph (d)(1) or (2) of this section, an importer may rely on the results of an inspection of the foreign supplier by FDA or the food safety authority of a country whose food safety system FDA has officially recognized as comparable or has determined to be equivalent to that of the United States, provided that the inspection was conducted within 1 year of the date that the onsite audit would have been required to be conducted. You must document the inspection results on which you rely. (ii) For inspections conducted by the food safety authority of a country whose food safety system FDA has officially recognized as comparable or determined to be equivalent, the food that is the subject of the onsite audit must be within the scope of the official recognition or equivalence determination, and the foreign supplier must be in, and under the regulatory oversight of, such country. (6) Review of results of verification activities. You must promptly review the results of the verification activities that you conduct or obtain documentation of under paragraph (d) of this section. If the results show that the risks for the food or foreign supplier identified in the determination you PO 00000 Frm 00025 Fmt 4701 Sfmt 4702 58597 made under § 1.505 are not adequately controlled, you must take appropriate action in accordance with § 1.507(c). (7) Independence of qualified individuals. A qualified individual who conducts any of the verification activities set forth in paragraph (d) of this section must not have a financial interest in the foreign supplier and payment must not be related to the results of the activity. This does not prohibit you or one of your employees from conducting the verification activity. ■ 8. Amend § 1.508 by revising paragraphs (a)(2) and (b) to read as follows: § 1.508 How must I reassess the effectiveness of my FSVP? (a) * * * (2) You must promptly reassess the effectiveness of your FSVP for a food you import when you become aware of new information about potential risks associated with the food or foreign supplier of the food. (b) Reassessment and implementation of changes. In conducting a reassessment of your FSVP as required by paragraph (a) of this section, you must update your risk evaluation for the food and foreign supplier in accordance with § 1.505. If the risks you previously identified change as a result of the reassessment, you must promptly determine whether the verification activities you conduct under § 1.506 or § 1.511(c) need to be changed to comply with that section, and you must promptly implement any such changes. You must document each reassessment you conduct and any resulting changes to your FSVP. ■ 9. Amend § 1.510 by revising paragraph (d)(2) to read as follows: § 1.510 How must I maintain records of my FSVP? * * * * * (d) Record retention. * * * (2) You must maintain records required under §§ 1.502(d) and 1.504(g) (customer assurances), § 1.506(d)(1)(i)(C), (d)(1)(ii)(B), (d)(1)(iii), and (d)(1)(iv) (certain verification activities), § 1.507 (investigations and corrective actions), § 1.508 (FSVP reassessments), § 1.511(b) (assurances from customers subject to certain dietary supplement current good manufacturing practice regulations), § 1.511(c)(5)(i)(C), (c)(5)(ii)(B), (c)(5)(iii), and (c)(5)(iv) (certain verification activities for importers of certain dietary supplements), and § 1.513(b) (food imported from a country with an officially recognized or equivalent food safety system) for a period of at least 2 E:\FR\FM\29SEP5.SGM 29SEP5 58598 Federal Register / Vol. 79, No. 188 / Monday, September 29, 2014 / Proposed Rules years after the records were created or obtained, except that you must maintain records of any changes to your FSVP in accordance with § 1.507(d) or § 1.508(b) until at least 2 years after their use is discontinued. ■ 10. Amend § 1.511 by: ■ a. Revising the first sentence of paragraph (a); ■ b. Revising paragraph (b); ■ c. Revising paragraphs (c)(1), (2), and (4); ■ d. Revising the second sentence of paragraph (c)(5) introductory text; ■ e. Revising paragraphs (c)(5)(i) through (iv), (6), (7), and (8); and ■ f. Removing paragraph (c)(9). The revisions read as follows: tkelley on DSK3SPTVN1PROD with PROPOSALS5 § 1.511 What FSVP must I have if I am importing a food subject to certain dietary supplement current good manufacturing practice regulations? (a) Importers subject to certain dietary supplement current good manufacturing practice regulations. If you are required to establish specifications under § 111.70(b), (d), or (f) of this chapter with respect to a food you import and you are in compliance with the requirements of part 111 of this chapter applicable to determining whether the specifications you established are met for such food, then for that food you must comply with the requirements in §§ 1.509 and 1.510, but you are not required to comply with the requirements in §§ 1.502 through 1.508. * * * (b) Importers whose customer is subject to certain dietary supplement current good manufacturing practice regulations. If your customer is required to establish specifications under § 111.70(b), (d), or (f) of this chapter with respect to a food you import, your customer is in compliance with the requirements of part 111 of this chapter applicable to determining whether the specifications it established are met for such food, and you annually obtain from your customer written assurance that it is in compliance with those requirements, then for that food you must comply with the requirements in §§ 1.509 and 1.510, but you are not required to comply with the requirements in §§ 1.502 through 1.508. (c) Other importers of dietary supplements. (1) General. If the food you import is a dietary supplement and neither paragraph (a) or (b) of this section is applicable, you must comply with paragraph (c) of this section and the requirements in §§ 1.503, 1.505(a)(2) through (a)(6) and (b), and 1.507 through 1.510, but you are not required to comply with the requirements in §§ 1.504 and 1.505(a)(1). This VerDate Sep<11>2014 17:13 Sep 26, 2014 Jkt 232001 requirement does not limit your obligations with respect to part 111 of this chapter or any other laws enforced by FDA. (2) Use of approved foreign suppliers. You must establish and follow written procedures to ensure that you import foods only from foreign suppliers that 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. * * * * * (4) Purpose of supplier verification. Your foreign supplier verification activities must provide adequate assurances that your supplier is producing the dietary supplement in accordance with processes and procedures that provide the same level of public health protection as those required under part 111 of this chapter. (5) Supplier verification activities. * * * You must determine and document which verification activity or activities are appropriate to provide adequate assurances in accordance with paragraph (c)(4) of this section. * * * (i) Periodic onsite auditing. You conduct (and document) or obtain documentation of a periodic onsite audit of your foreign supplier. (A) An onsite audit of a supplier must be performed by a qualified auditor. (B) The onsite audit must consider the requirements of part 111 of this chapter and must include a review of the foreign supplier’s written food safety plan, if any, and the supplier’s implementation of such plan. (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. (ii) Periodic or lot-by-lot sampling and testing of the food. (A) Sampling and testing of the dietary supplement may be conducted by you or the foreign supplier. (B) You must retain documentation of each sampling and testing of a dietary supplement, including identification of the food tested (including lot number, as appropriate), the number of samples tested, the test(s) conducted (including the analytical method(s) used), the date(s) on which the test(s) were conducted, the results of the testing, any PO 00000 Frm 00026 Fmt 4701 Sfmt 4702 corrective actions taken in response to detection of hazards, and information identifying the laboratory conducting the testing. (iii) Periodic review of the foreign supplier’s food safety records. You must retain documentation of each record review, including the date(s) of review, any corrective actions taken in response to significant deficiencies identified during the review, and documentation that the review was conducted by a qualified individual. (iv) Other appropriate activity. You may conduct other supplier verification activities that are appropriate based on the risks associated with the food and the foreign supplier. You must document each performance of such verification activity. (6) Substitution of inspection by FDA or an officially recognized or equivalent food safety authority. Instead of an onsite audit conducted under paragraph (c)(5)(i) of this section, an importer may rely on the results of an inspection of the foreign supplier conducted by FDA or the food safety authority of a country whose food safety system FDA has officially recognized as comparable or determined to be equivalent to that of the United States, provided that the inspection was conducted within 1 year of the date that the onsite audit would have been required to be conducted. You must document the inspection results on which you rely. For inspections conducted by the food safety authority of a country whose food safety system FDA has officially recognized as comparable or determined to be equivalent, the food that is the subject of the onsite audit must be within the scope of the official recognition or equivalence determination, and the foreign supplier must be in, and under the regulatory oversight of, such country. (7) Review of results of verification activities. You must promptly review the results of the verification activities that you conduct or obtain documentation of under paragraph (c)(5) of this section. If the results show that the foreign supplier does not meet the standard in paragraph (c)(4) of this section, you must take appropriate action in accordance with § 1.507(c). (8) Independence of qualified individuals conducting verification activities. A qualified individual who conducts any of the verification activities set forth in paragraph (c)(5) of this section must not have a financial interest in the foreign supplier and payment must not be related to the results of the activity. This does not prohibit you or one of your employees E:\FR\FM\29SEP5.SGM 29SEP5 Federal Register / Vol. 79, No. 188 / Monday, September 29, 2014 / Proposed Rules from conducting the verification activity. ■ 11. Amend § 1.512 by: ■ a. Revising paragraph (b)(2); ■ b. Removing paragraph (b)(3); ■ c. Redesignating paragraphs (b)(4) and (5) as paragraphs (b)(3) and (4), respectively; ■ d. Revising newly redesignated paragraph (b)(4); and ■ e. Removing paragraph (b)(6). The revisions read as follows: § 1.512 What FSVP may I have if I am a very small importer or I am importing food from a very small supplier? * * * * (b) Applicable requirements. * * * (2) Additional requirements. If this section applies and you choose to comply with the requirements in paragraph (b) of this section, you also are required to comply with the requirements in §§ 1.502, 1.503, and 1.509, but you are not required to tkelley on DSK3SPTVN1PROD with PROPOSALS5 * VerDate Sep<11>2014 17:13 Sep 26, 2014 Jkt 232001 comply with the requirements in §§ 1.504 through 1.508 or § 1.510. * * * * * (4) Corrective actions. You must promptly take appropriate corrective actions if you determine that a foreign supplier of food you import does not produce 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 or 419 of the Federal Food, Drug, and Cosmetic Act, if either is applicable, or produces food that is adulterated under section 402 or misbranded under section 403(w) of the Federal Food, Drug, and Cosmetic Act. The appropriate corrective actions will depend on the circumstances but could include discontinuing use of the foreign supplier until the cause or causes of noncompliance, adulteration, or misbranding have been adequately addressed. You must document any corrective actions you take in accordance with this paragraph (b)(4). PO 00000 Frm 00027 Fmt 4701 Sfmt 9990 58599 This paragraph (b)(4) does not limit your obligations with respect to other laws enforced by FDA, such as those relating to product recalls. ■ 12. Amend § 1.513 by revising paragraph (a) to read as follows: § 1.513 What FSVP may I have if I am importing a food from a country with an officially recognized or equivalent food safety system? (a) General. If you meet the conditions and requirements of paragraph (b) of this section for a food you are importing, then you are not required to comply with the requirements in §§ 1.503 through 1.508. You would still be required to comply with the requirements in §§ 1.509 and 1.510. * * * * * Dated: September 16, 2014. Peter Lurie, Associate Commissioner for Policy and Planning. [FR Doc. 2014–22448 Filed 9–19–14; 8:45 am] BILLING CODE 4164–01–P E:\FR\FM\29SEP5.SGM 29SEP5

Agencies

[Federal Register Volume 79, Number 188 (Monday, September 29, 2014)]
[Proposed Rules]
[Pages 58573-58599]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-22448]



[[Page 58573]]

Vol. 79

Monday,

No. 188

September 29, 2014

Part V





 Department of Health and Human Services





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 Food and Drug Administration





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21 CFR Part 1





 Foreign Supplier Verification Programs for Importers of Food for 
Humans and Animals; Proposed Rule

Federal Register / Vol. 79 , No. 188 / Monday, September 29, 2014 / 
Proposed Rules

[[Page 58574]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. FDA-2011-N-0143]
RIN 0910-AG64


Foreign Supplier Verification Programs for Importers of Food for 
Humans and Animals

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; supplemental notice of proposed rulemaking.

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SUMMARY: The Food and Drug Administration (FDA) is revising certain 
provisions of the proposed rule, issued in July 2013, on foreign 
supplier verification programs (FSVPs) for importers of food for humans 
and animals. We are primarily revising the proposed requirements 
concerning compliance status review of food and foreign suppliers, 
hazard analysis, and supplier verification activities. We are taking 
this action in response to the extensive public input we have received 
regarding these provisions and in coordination with revisions we are 
concurrently making to the proposed rule on current good manufacturing 
practice (CGMP) and hazard analysis and risk-based preventive controls 
for human food. We are seeking public comment on the revised proposed 
FSVP regulations. We are reopening the comment period on the proposed 
rule only with respect to the specific provisions identified in this 
Federal Register document.

DATES: Submit either electronic or written comments on the supplemental 
notice of proposed rulemaking by December 15, 2014. Submit comments on 
information collection issues under the Paperwork Reduction Act of 1995 
by December 15, 2014 (see the ``Paperwork Reduction Act of 1995'' 
section of this document).

ADDRESSES: You may submit comments by any of the following methods, 
except that comments on information collection issues under the 
Paperwork Reduction Act of 1995 must be submitted to the Office of 
Regulatory Affairs, Office of Management and Budget (OMB) (see the 
``Paperwork Reduction Act of 1995'' section of this document).

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper submissions): 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Docket No. 
(FDA-2011-N-0143) for this rulemaking. All comments received may be 
posted without change to http://www.regulations.gov, including any 
personal information provided. For additional information on submitting 
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION 
section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number(s), found in brackets in the heading of this document, 
into the ``Search'' box and follow the prompts and/or go to the 
Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, 
MD 20852.

FOR FURTHER INFORMATION CONTACT: Brian Pendleton, Office of Policy, 
Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, 
MD 20993-0002, 301-796-4614; or Domenic Veneziano, Office of 
Enforcement and Import Operations (ELEM-3108), Office of Regulatory 
Affairs, Food and Drug Administration, 12420 Parklawn Dr., Element 
Bldg., Rockville, MD 20857, 301-796-6673.

SUPPLEMENTARY INFORMATION:

Table of Contents

Executive Summary
    Purpose of the Supplemental Notice of Proposed Rulemaking
    Summary of the Revisions to the Proposed Rule
    Costs and Benefits
I. Background
    A. Proposed Rule on FSVPs
    B. Public Comments
    C. Alignment of FSVP Regulations With Potential Supplier 
Verification Provisions in the Proposed Preventive Controls 
Regulations
    D. Decision To Issue Supplemental Notice of Proposed Rulemaking 
Regarding Certain Preventive Controls Requirements
    E. Scope of FSVP Supplemental Notice of Proposed Rulemaking
II. Revisions to the Proposed Rule
    A. Compliance Status Review
    B. Hazard Analysis
    C. Supplier Verification
    D. Definitions of Very Small Importers and Very Small Foreign 
Suppliers
    E. Other Related Revisions
III. Preliminary Regulatory Impact Analysis
IV. Paperwork Reduction Act of 1995
V. Analysis of Environmental Impact
VI. Comments
VII. References

Executive Summary

Purpose of the Supplemental Notice of Proposed Rulemaking

    We are revising certain provisions of the proposed rule, issued in 
July 2013, on FSVPs for importers of food for humans and animals. The 
revisions primarily concern the proposed rule's requirements on 
compliance status review of food and foreign suppliers, hazard 
analysis, and supplier verification activities. We are issuing these 
revisions in response to extensive public input we have received 
regarding these provisions and in alignment with certain revisions we 
are concurrently making to the proposed rule on preventive controls for 
human food.

Summary of the Revisions to the Proposed Rule

    One revision to the proposed rule would, consistent with many 
comments we received, delete the previously proposed section on 
compliance status review but incorporate some of the provisions into 
the requirements concerning hazard analysis and evaluation of certain 
risk factors in determining appropriate foreign supplier verification 
and related activities.
    Another revision would modify some of the previously proposed 
hazard analysis requirements. In accordance with several comments we 
received, as well as the revised hazard analysis provisions and new 
supplier program provisions in the revised preventive controls proposal 
that we are concurrently issuing, the revised FSVP proposal changes the 
requirement to analyze hazards that are reasonably likely to occur to a 
requirement to analyze known or reasonably foreseeable hazards to 
determine if they are significant. Under the revised proposal, a 
significant hazard would be defined as a known or reasonably 
foreseeable hazard in a food 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 and components to manage those 
controls (such as monitoring, corrections and corrective actions, 
verification, and records), as appropriate to the food, the facility, 
and the control.

[[Page 58575]]

    Other changes related to the proposed hazard analysis requirements 
that are consistent with the proposed hazard analysis requirements in 
the preventive controls proposal include requiring analysis of hazards 
that may be intentionally introduced for purposes of economic gain, 
requiring evaluation of environmental pathogens in certain ready-to-eat 
food, and minor changes to other hazard evaluation factors.
    Another revision to the previous proposed rule would specify that, 
along with the hazard analysis, the importer must consider other 
factors primarily related to supplier risks in determining appropriate 
supplier verification and related activities before importing a food 
from a particular foreign supplier and thereafter when the importer 
becomes aware of new information about these risks. These proposed 
changes respond to numerous comments stating that industry best 
practice is to base supplier verification activities on an assessment 
of information about the risks presented by a food as well as by the 
supplier of the food, rather than focusing primarily on hazards 
inherent in food. Under the revised proposal, in addition to the hazard 
analysis, the importer would be required to consider the following in 
approving suppliers and determining appropriate verification 
activities:
     The entity that will be applying hazard controls, such as 
the foreign supplier or the foreign supplier's raw material or 
ingredient supplier.
     The foreign supplier's procedures, processes, and 
practices related to the safety of the food.
     Applicable FDA food safety regulations and information 
regarding the foreign supplier's compliance with those regulations, 
including whether the foreign supplier is the subject of an FDA warning 
letter or import alert.
     The foreign supplier's food safety performance history, 
including results from testing foods for hazards, audit results 
relating to the safety of the food, and the supplier's record of 
correcting problems.
     Any other factors as appropriate and necessary, such as 
storage and transportation practices.
    We also are revising certain proposed requirements regarding 
supplier verification measures themselves and related activities. 
Instead of maintaining a list of their foreign suppliers, importers 
would be required to establish and follow procedures to ensure that 
they import foods only from foreign suppliers that they have approved 
(except, when necessary and appropriate, from unapproved suppliers on a 
temporary basis). Consistent with the revised proposal's focus on a 
broader evaluation of risks, we are proposing that, rather than being 
designed to ensure that identified hazards are adequately controlled, 
the purpose of importers' supplier verification activities should be to 
provide adequate assurances that the foreign supplier produces the food 
in a manner consistent with FDA's regulations on preventive controls or 
produce safety, if either is applicable to the foreign supplier, and to 
assure that the food is not adulterated and not misbranded regarding 
allergen labeling. This approach is consistent with the purpose for 
foreign supplier verification specified in section 805(a)(1) of the 
Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 384a).
    After considering comments on the alternative proposals we 
presented in the 2013 proposed rule regarding supplier verification 
activities, we are proposing an approach that gives importers the 
flexibility to determine appropriate verification measures based on 
food and supplier risks, while acknowledging the greater risk to public 
health posed by the most serious hazards in foods. Under the revised 
proposal, based on the risk evaluation the importer conducts, the 
importer would be required to determine and document what supplier 
verification activities are appropriate for a particular food and 
foreign supplier, as well as the frequency with which those activities 
should be conducted. Appropriate supplier verification activities could 
include onsite auditing of the foreign supplier, sampling and testing 
of food, review of the supplier's food safety records, or some other 
procedure determined to be appropriate based on the identified risks.
    However, the revised proposal also specifies that, when there is a 
hazard in a food that could result in serious adverse health 
consequences or death to humans or animals (a ``SAHCODHA'' hazard), an 
importer would need to conduct or obtain documentation of an onsite 
audit of the foreign supplier before initially importing the food and 
at least annually thereafter, unless the importer specifically 
determined that some other supplier verification activity and/or less 
frequent auditing would adequately address the identified risks. This 
requirement would establish a clear verification standard for these 
most serious food hazards yet permit importers to employ a different 
approach if they can confirm that the alternative approach will provide 
adequate assurance that the identified risks are addressed.
    We tentatively conclude that this revised proposal regarding 
supplier verification activities strikes an appropriate balance between 
granting importers the flexibility to adopt risk-based verification 
measures while increasing the likelihood that importers will apply the 
most rigorous verification measures to the most serious risks.
    The revised proposal also would specify that if a foreign supplier 
is a farm that is not subject to the produce safety regulations, the 
importer of food from the supplier would not be subject to the 
``standard'' verification requirements previously noted but would 
instead be required to obtain written assurance biennially that the 
supplier is producing the food in compliance with the FD&C Act. This 
proposed change reflects the different treatment of food from such 
farms under the produce safety regulations and would be consistent with 
the potential requirement for a supplier program in the preventive 
controls regulations.
    In addition, we are proposing to add provisions stating that when 
importers or their customers are in compliance with the requirements on 
supplier programs in the proposed preventive controls regulations, the 
importers would be deemed in compliance with most of the FSVP 
requirements (in cases involving customer compliance with the supplier 
program requirements, the importer would need to obtain written 
assurance of compliance annually from the customer). This proposed 
change is consistent with our intent, stated in the FSVP and preventive 
controls proposed rules, to avoid imposing redundant regulatory 
requirements on food importers who also are food facilities subject to 
the preventive controls regulations.
    Finally, we are increasing, from $500,000 to $1 million, the annual 
sales ceiling used in the proposed definition of ``very small 
importer'' and ``very small foreign supplier'' to be consistent with 
our revised approach to the proposed definition of ``very small 
business'' under the proposed preventive controls regulations.

Costs and Benefits

    We summarize the annualized costs (over a 10-year time period 
discounted at both 3 percent and 7 percent) of the revised proposed 
rule in the following table.

[[Page 58576]]



------------------------------------------------------------------------
                                          3 percent         7 percent
------------------------------------------------------------------------
Annualized Cost.....................      $396,780,114      $397,478,400
Reduction in Cost Relative to               76,191,228        75,901,638
 Original Option 1..................
Reduction in Cost Relative to               64,627,341        64,343,306
 Original Option 2..................
------------------------------------------------------------------------

    The reduction in FSVP requirements for importers who also would be 
subject to the preventive controls regulations, and other proposed 
changes in the requirements, results in a cost savings of $76 million 
per year (compared to Option 1 of the 2013 proposed rule). The overall 
potential net benefit from the revised proposed rule is estimated at 
$714 million per year. These figures are based on a 3 percent discount 
rate, a scenario for inflation, over 10 years. (The figures are the 
same for a 7 percent discount rate.)
    Although the FSVP proposed rule would not itself establish safety 
requirements for food manufacturing and processing, it would benefit 
the public health by helping to ensure that imported food is produced 
in a manner consistent with other applicable food safety regulations. 
The Preliminary Regulatory Impact Analyses for the proposed rules on 
preventive controls for human food and standards for produce safety 
consider and analyze the number of illnesses and deaths that the 
proposed regulations are aimed at reducing. The greater the compliance 
with those regulations, the greater the expected reduction in illnesses 
and deaths as well as the costs associated with them. The FSVP 
regulations would be an important mechanism for improving and ensuring 
compliance with the previously noted food safety regulations as they 
apply to imported food. For this reason, we account for the public 
health benefits of the FSVP proposed rule in the preventive controls, 
produce safety, and other applicable food safety regulations instead of 
in this rule.

I. Background

A. Proposed Rule on FSVPs

    On July 29, 2013, FDA published in the Federal Register a proposed 
rule entitled ``Foreign Supplier Verification Programs for Importers of 
Food for Humans and Animals'' (``the 2013 FSVP proposed rule'' or ``the 
previous proposed rule'') (78 FR 45730) to require importers to perform 
certain activities to help ensure that the food they bring into the 
United States is produced in a manner consistent with U.S. standards.
    FDA proposed the FSVP regulations as part of our implementation of 
the FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353). Section 
301 of FSMA adds section 805 to the FD&C Act to require persons who 
import food into the United States to perform risk-based foreign 
supplier verification activities for the purpose of verifying the 
following: (1) The food is produced in compliance with section 418 
(concerning hazard analysis and risk-based preventive controls) or 419 
(concerning standards for the safe production and harvesting of certain 
fruits and vegetables that are raw agricultural commodities (RACs)) of 
the FD&C Act (21 U.S.C. 350g and 350h), as appropriate; (2) the food is 
not adulterated under section 402 of the FD&C Act (21 U.S.C. 342); and 
(3) the food is not misbranded under section 403(w) of the FD&C Act (21 
U.S.C. 343(w)) (concerning food allergen labeling). Section 805(c) of 
the FD&C Act directs FDA to issues regulations on the content of 
importers' FSVPs.
    The FSVP proposed rule would require food importers to adopt 
programs to ensure that the food they import meets the previously noted 
statutory standards. The previous proposed rule would have required 
importers to take the following actions as part of their FSVPs:
     Use a qualified individual to perform most FSVP 
activities.
     Review the compliance status of foods and foreign 
suppliers.
     Analyze the hazards reasonably likely to occur with foods.
     Determine and perform appropriate foreign supplier 
verification activities for foods. As discussed in more detail in 
section II.C.5, the proposal set forth two optional approaches to 
verification requirements that differ primarily with respect to the 
verification activities that importers must conduct when a SAHCODHA 
hazard is present in a food.
     Review complaints, conduct investigations of adulterated 
or misbranded food, take corrective actions when appropriate, and 
modify the FSVP when it is determined to be inadequate.
     Reassess the effectiveness of the FSVP.
     Ensure that information identifying the importer is 
submitted upon entry of a food into the United States.
     Maintain records of FSVP procedures and activities.
    In addition to these ``standard'' FSVP requirements that would 
apply to most food importers, the previous proposed rule included 
modified requirements for the following:
     Importers of dietary supplements and dietary supplement 
components.
     Very small importers and importers of food from very small 
foreign suppliers.
     Importers of food from foreign suppliers in countries 
whose food safety systems FDA has officially recognized as comparable 
or determined to be equivalent to the U.S. food safety system.

B. Public Comments

    We requested comments on the FSVP proposed rule by November 26, 
2013. We extended the comment period for the proposed rule and its 
information collection provisions (which are subject to review by OMB 
under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-
3520)) (78 FR 69602, November 20, 2013). The comment period for the 
proposed rule closed on January 27, 2014.
    After we published the FSVP proposed rule in July 2013, we held two 
public meetings to solicit stakeholder and public comments on the 
proposed rule, inform the public about the rulemaking process, and 
respond to questions about the proposed rule (see 78 FR 57320, 
September 18, 2013). We also made other presentations, participated in 
Webinars, and met with stakeholders in the United States and abroad to 
discuss the FSVP proposed rule along with proposed rules implementing 
other FSMA provisions.
    Over 350 comments were submitted to the docket on the FSVP proposed 
rule. We continue to review these comments as part of our development 
of the final rule on FSVPs. However, for the reasons discussed in 
sections I.C through I.E, we are issuing revisions to certain 
provisions in the previous proposed rule and requesting comment on the 
revisions.

C. Alignment of FSVP Regulations With Potential Supplier Verification 
Provisions in the Proposed Preventive Controls Regulations

    In the FSVP proposed rule, we stated that we recognized the 
importance of coordinating the FSVP regulations with any supplier 
verification provisions that might be included in the regulations on 
preventive controls for human and animal food (78 FR 45730 at 45740 to

[[Page 58577]]

45741, 45747 to 45748). We had first expressed that intent in the 
proposed rule on ``Current Good Manufacturing Practice and Hazard 
Analysis and Risk-Based Preventive Controls for Human Food'' (the 
``Preventive Controls proposed rule'') (78 FR 3646, January 16, 2013). 
Although the Preventive Controls proposed rule did not include specific 
regulations on supplier verification, the Agency requested comment on 
when and how approval and verification of suppliers of raw materials 
and ingredients are an appropriate part of preventive controls, and 
sought comment on different aspects of supplier approval and 
verification programs (78 FR 3646 at 3665 to 3667). We also stated that 
we intended to align any supplier verification provisions in the 
preventive controls regulations with the FSVP regulations to avoid 
imposing duplicative requirements on entities that are subject to each 
of those sets of regulations because they are both registered food 
facilities and food importers. We expressed a similar intent regarding 
alignment with any supplier verification provisions that might be 
included in the proposed regulations on preventive controls for animal 
food (see ``Current Good Manufacturing Practice and Hazard Analysis and 
Risk-Based Preventive Controls for Food for Animals,'' 78 FR 64736 at 
64808, October 29, 2013).
    In the FSVP proposed rule, we requested comment on how to address 
foreign supplier verification by importers who could be subject to both 
the FSVP and preventive controls regulations to avoid imposing 
duplicative requirements on such firms. In particular, we requested 
comment on whether the FSVP regulations should state that if an 
importer was required to establish a supplier approval and verification 
program under the preventive controls regulations for a food, and was 
in compliance with those regulations, the importer would be deemed to 
be in compliance with the FSVP regulations that address those matters 
(78 FR 45730 at 45748).

D. Decision To Issue Supplemental Notice of Proposed Rulemaking 
Regarding Certain Preventive Controls Requirements

    In December 2013, we issued a statement (Ref. 1) noting the 
extensive input we had received from produce farmers and others in the 
agricultural sector on the Preventive Controls proposed rule and FDA's 
2013 proposed rule on ``Standards for the Growing, Harvesting, Packing, 
and Holding of Produce for Human Consumption'' (``the Produce Safety 
proposed rule'') (78 FR 3504, January 16, 2013). We expressed our 
belief that significant changes would be needed in key provisions of 
the two proposed rules affecting small and large farmers, such as 
certain provisions affecting mixed-use facilities (i.e., facilities co-
located on a farm). We also announced our intent to propose revised 
regulatory requirements and request comment on them, allowing the 
public the opportunity to provide input on our new thinking. We noted 
that there might be other revisions to these proposed rules that we 
would issue for public comment, and that we would determine the scope 
of the revised proposals as we completed our initial review of the 
submitted comments on the proposed rules.

E. Scope of FSVP Supplemental Notice of Proposed Rulemaking

    In accordance with our December 2013 statement, elsewhere in this 
issue of the Federal Register we are issuing a supplemental notice of 
proposed rulemaking regarding the preventive controls for human food 
proposed rule (``Preventive Controls supplemental document'') and a 
supplemental notice of proposed rulemaking regarding the rule on 
preventive controls for animal food. In addition to revisions to 
previously proposed requirements, the Preventive Controls supplemental 
document includes proposed provisions on supplier programs for food 
facilities that receive raw materials and ingredients. To align the 
FSVP proposed regulations with the provisions on supplier programs in 
the revised Preventive Controls proposed rule, and in response to 
comments that we have received concerning certain related issues in the 
FSVP proposal, we are revising the FSVP proposed rule. As discussed in 
detail in section II, the principal changes to the FSVP proposal 
include the following:
     Deleting the previously proposed section requiring 
importers to conduct a compliance status review of the food and foreign 
supplier but incorporating some parts of this section into the 
previously proposed requirement to conduct a hazard analysis of the 
food and a newly proposed requirement to evaluate other risks 
associated with the food and foreign supplier.
     Replacing the previously proposed requirement to analyze 
hazards that are ``reasonably likely to occur'' with a proposed 
requirement to analyze ``known or reasonably foreseeable'' hazards to 
determine if they are significant (i.e., necessitate control measures).
     Giving importers the flexibility to conduct the supplier 
verification activities that they have determined, based on their 
evaluation of food and foreign supplier risks, can provide adequate 
assurance that the supplier is producing the food in a manner 
consistent with U.S. food safety requirements. For foods that are 
associated with a SAHCODHA hazard, the revised proposal specifically 
requires initial and subsequent annual onsite auditing of the foreign 
supplier unless the importer determines, based on its risk evaluation 
of the food and foreign supplier, that other verification activities 
are appropriate and adequate.
    We discuss these revised proposed requirements in section II. We 
are reopening the comment period on the proposed rule only with respect 
to these matters. In the FSVP final rule, we will take into account 
public comments already received and any comments received in response 
to this document in finalizing the FSVP requirements.
    The previous proposed rule and the revisions and new provisions in 
this supplemental notice of proposed rulemaking, taken together, 
constitute the entirety of the proposed rule on FSVPs. Throughout this 
document, we discuss revisions to the previously proposed subpart L of 
21 CFR part 1 and, in the codified section of this supplemental notice 
of proposed rulemaking, we list each of the revised and new provisions 
of proposed subpart L. For the convenience of readers and ease of 
reference, we prepared a separate document (to be included in the 
public docket for this rulemaking) that identifies the changes to the 
previous codified provisions and provides the complete proposed subpart 
L of 21 CFR part 1, as revised through this document (Ref. 2).

II. Revisions to the Proposed Rule

    As stated in section I.E, in response to comments we have received 
and as part of our effort to align the FSVP requirements with the 
supplier program provisions in the revised Preventive Controls proposed 
rule, we are making several revisions to the FSVP proposed rule. These 
changes focus primarily on importers' evaluation of the risks 
associated with the foods they import and the foreign suppliers of this 
food, along with the supplier verification activities that importers 
must conduct.
    Although we have tried to align the supplier verification 
provisions in the FSVP and preventive controls regulations as much as 
possible, there are some differences between the two. These differences 
are largely due to statutory language and the fact that

[[Page 58578]]

while supplier verification is the principal focus of the FSVP 
regulations, it would only be a component of the preventive controls 
regulations if it is included in the final preventive controls 
regulations. These factors result in the two sets of proposed 
regulations being structured somewhat differently. We request comment, 
in light of the statutory provisions, on the manner and extent to which 
the FSVP and preventive controls supplier verification provisions--as 
well as other aspects of the FSVP and preventive controls regulations--
should be aligned in the final rules.

A. Compliance Status Review

    The previous FSVP proposed rule included two requirements 
concerning importers' review of information related to the risk 
associated with foods and/or foreign suppliers. These are:
     A requirement to review the compliance status of each food 
to be imported and each foreign supplier being considered (previously 
proposed Sec.  1.504); and
     A requirement to analyze the hazards in each food 
(previously proposed Sec.  1.505).
    Regarding compliance status review, proposed Sec.  1.504 would have 
required an importer, before importing a food from a foreign supplier, 
to assess the compliance status of the food and the foreign supplier, 
including whether either is the subject of an FDA warning letter, 
import alert, or requirement for certification issued under section 
801(q) of the FD&C Act (21 U.S.C. 381(q)) relating to the safety of the 
food, to determine whether it would be appropriate to import the food 
from the foreign supplier. Proposed Sec.  1.504 also would have 
required an importer to document this review and to continue to monitor 
and document the compliance status as long as the importer obtains the 
food from the foreign supplier.
1. Comments
    We received many comments about the proposed compliance status 
review provisions. A frequent comment by food importers on the 
compliance status review requirements is that the proposal places too 
much emphasis on compliance status review, in particular on warning 
letters and import alerts, as a basis for determining appropriate 
supplier verification activities. Several comments maintain that 
compliance status review should be regarded as just one part of an 
analysis of the risks associated with a food and the foreign supplier 
of the food. However, several comments state that supplier verification 
activities should be based not solely on an analysis of the hazards in 
a food but also on the potential risks associated with a foreign 
supplier of the food.
    Some comments state that an importer should consider both positive 
and negative compliance information about a foreign supplier. One 
comment states that each importer should determine on its own what 
information is relevant to review about a supplier's risk, which might 
include assessing a supplier's compliance status.
    Some comments express concern that certain information about a 
firm's compliance status, such as FDA Form 483 inspection reports and 
consent decrees, could be too difficult to obtain because they might be 
available only through a request under the Freedom of Information Act. 
In addition, some comments maintain that the FDA Web site is 
insufficiently organized and would have to be updated to track food and 
foreign supplier compliance status. Some comments state that an 
importer should be free to determine on its own what information about 
the risk of a foreign supplier is relevant to consider.
    Many comments express concern that the proposal did not specify how 
frequently an importer must conduct a compliance status review. Several 
comments recommend that importers be required to conduct these reviews 
annually. Some comments object to a continuous monitoring requirement 
as unnecessary and suggest instead that an importer be required to 
reassess its supplier's compliance status as part of the importer's 
reassessment of its FSVP when the importer becomes aware of new 
information about potential hazards associated with the food or 
supplier.
2. Revisions Regarding Food and Foreign Supplier Risk Evaluation
    Contrary to how some of the commenters read the proposed 
requirements, the previous proposal would not have required importers 
to consider only whether there was a relevant warning letter, import 
alert, or certification requirement under section 801(q) of the FD&C 
Act; rather, the importer would have needed to consider information 
relevant to the compliance status of the food and the foreign supplier, 
e.g., warning letters and import alerts. The preamble to the 2013 
proposed rule discussed other types of information about a food or 
foreign supplier's compliance status, such as Form FDA 483s, 
Establishment Inspection Reports, and recall notices.
    We agree, however, that importers should consider both food and 
supplier risks in developing their supplier verification plans. 
Therefore, we tentatively conclude that it is appropriate to more 
clearly specify that importers must consider certain information 
relevant to the risks associated with a food and the foreign supplier. 
Rather than have a separate section requiring importers to conduct a 
compliance status review of foods and potential foreign suppliers, we 
are incorporating these compliance concerns into the proposed risk 
evaluation requirements.
    We now are proposing to establish provisions requiring importers to 
evaluate the risks associated with the food and the potential foreign 
supplier to determine whether it is appropriate to approve the 
importation of the food from the foreign supplier. In addition to 
requiring importers to consider the hazards they determine to be 
significant under proposed Sec.  1.504 in the revised regulatory text 
(discussed in section II.B), proposed Sec.  1.505(a)(1) in the revised 
regulatory text would require importers to consider the following:
     The entity that will be applying controls for the 
identified hazards, such as the foreign supplier or the foreign 
supplier's raw material or ingredient supplier. As stated in the 
preamble to the 2013 proposed rule, we believe that the person who will 
be controlling a hazard in a food is an important, though not 
necessarily the only, factor in determining an appropriate supplier 
verification activity for the food.
     The foreign supplier's procedures, processes, and 
practices related to the safety of the food. Many comments state that 
various aspects associated with the manner in which a foreign supplier 
produces a food can affect the risk associated with the supplier.
     Applicable FDA food safety regulations and information 
regarding the foreign supplier's compliance with those regulations, 
including whether the supplier is the subject of an FDA warning letter 
or import alert. There is widespread acknowledgement among the comments 
that a foreign supplier's history of compliance with applicable FDA 
regulations is an important component (though not the only component) 
of supplier risk evaluation. Documents such as warning letters and 
import alerts are available on FDA's Web site; we tentatively conclude 
that we would not require importers to consider non-public information 
regarding compliance with FDA regulations unless such information was 
available to the importer (e.g., provided to the importer by the 
foreign supplier).
     The foreign supplier's food safety performance history, 
including results from testing foods for hazards, audit

[[Page 58579]]

results relating to the safety of the food, and the supplier's record 
of correcting problems. Several comments state that an importer 
typically considers a foreign supplier's performance in providing 
products that meet the importer's specifications, as verified through 
onsite auditing, testing, or other measures, in determining the form 
and frequency of verification activities to conduct.
     Any other factors as appropriate and necessary, such as 
storage and transportation practices. We believe that there might be 
factors not previously specified that in certain circumstances an 
importer should consider in evaluating food and supplier risks, such as 
storage and transportation practices or recent changes to the 
management of a foreign supplier.
    Proposed Sec.  1.505(a)(2) in the revised proposed regulatory text 
would require the importer to document each risk evaluation it 
conducts.
    We tentatively conclude that this approach to risk evaluation 
requirements provides a more complete and specific listing (compared to 
the combined requirements in the previous proposal regarding compliance 
status review and hazard analysis) of the factors noted by many 
comments as being the issues that importers typically consider in 
evaluating food and foreign supplier risks. Under the revised proposal, 
importers would need to consider each of the previously listed factors 
in performing their food and foreign supplier risk evaluations. We 
intend to issue guidance on the specific information that we believe 
should be considered under each of these factors and how these factors 
might be weighed in evaluating overall risk.
    These proposed risk evaluation factors closely align with the 
factors that receiving facilities must consider in determining 
appropriate raw material and ingredient supplier verification 
activities under the supplier program provisions of the revised 
Preventive Controls proposed rule.
    We believe that it is not necessary to mandate a specific frequency 
(e.g., on an annual basis) for a complete reanalysis of the risks 
associated with a food or foreign supplier. Instead, we believe that an 
importer should reevaluate food and supplier risks when it obtains new 
information about these risks, either through the importer's own 
investigation or from the foreign supplier, FDA, or some other source. 
Therefore, proposed Sec.  1.504(b) in the revised regulatory text would 
require an importer to promptly evaluate the risks associated with a 
food or foreign supplier when the importer becomes aware of new 
information about the risks. We intend to provide guidance on the 
circumstances under which importers should reevaluate food and supplier 
risks.

B. Hazard Analysis

    The other requirement in the previous proposed rule that concerned 
evaluation of food and supplier risk was the requirement to conduct a 
hazard analysis. Previously proposed Sec.  1.505(a) would require each 
importer (with certain exceptions) to determine, for each food 
imported, the hazards, if any, that are reasonably likely to occur with 
the food and, for each, the severity of the illness or injury if such a 
hazard were to occur. The importer would need to document this 
determination and use it to determine appropriate supplier verification 
activities.
    Previously proposed Sec.  1.505(b) states that an importer's 
evaluation of the hazards that are reasonably likely to occur with each 
food that is imported must consider the following potential hazards 
that may occur naturally or may be unintentionally introduced: 
Biological hazards, including microbiological hazards such as parasites 
and environmental pathogens, and other microorganisms of public health 
significance; chemical hazards, including substances such as pesticide 
and drug residues, natural toxins, decomposition, unapproved food or 
color additives, and food allergens; physical hazards; and radiological 
hazards.
    Previously proposed Sec.  1.505(c) states that, in evaluating the 
hazards in Sec.  1.505(b), the importer must consider the effect of 
several factors on the safety of the finished food for the intended 
consumer. These factors are as follows: The ingredients of the food; 
the condition, function, and design of the foreign supplier's 
establishment and equipment; transportation practices; harvesting, 
raising, manufacturing, processing, and packing procedures; packaging 
and labeling activities; storage and distribution; intended or 
reasonably foreseeable use; sanitation, including employee hygiene; and 
any other relevant factors.
    Previously proposed Sec.  1.505(d) would permit an importer to 
identify the hazards that are reasonably likely to occur for a 
particular food by reviewing and evaluating the hazard analysis 
conducted by the foreign supplier (rather than conducting an entirely 
separate evaluation of hazards using information that the importer 
itself has obtained).
    Finally, under previously proposed Sec.  1.505(e), for a RAC that 
is a fruit or vegetable, an importer would not be required to conduct a 
hazard analysis regarding the microbiological hazards that might be 
reasonably likely to occur with this food. Instead, the importer would 
need to verify that this kind of food is produced in compliance with 
FDA's produce safety standards, once finalized, or equivalent 
standards.
    As stated in section II.A.2, our revised proposal would continue to 
require an importer to analyze the hazards in a food that it imports, 
with the hazard analysis being one part of the food and foreign 
supplier risk evaluation that the importer must conduct under Sec.  
1.505 in the revised regulatory text. In this section, we discuss 
certain revisions we are making to the hazard analysis requirements in 
the proposed rule.
1. Nature of the Hazards That Importers Must Analyze
a. Comments
    Several comments object to the proposed requirement that importers' 
hazard analyses focus on hazards that are ``reasonably likely to 
occur'' with a food. We proposed to define a hazard reasonably likely 
to occur as one for which a prudent importer would establish controls 
or verify that the supplier controls because experience, illness data, 
scientific reports, or other information provides a basis to conclude 
that there is a reasonable possibility that the hazard will occur in 
the type of food being imported in the absence of those controls. One 
comment states that the ``reasonably likely to occur'' standard should 
not be used because it goes beyond and is inconsistent with the ``known 
or reasonably foreseeable'' statutory standard in FSMA's preventive 
controls provisions (section 418(b)(1) of the FD&C Act). Several 
comments maintain that the term reasonably likely to occur typically 
has been used to determine critical control points for hazard analysis 
and critical control points (HACCP) systems and is inappropriate for 
use in a program like supplier verification that is a ``prerequisite,'' 
foundational food safety program. The comments recommend instead that 
importers be required to consider ``known or reasonably foreseeable'' 
hazards because determining such hazards requires knowledge of the 
facility in which the food is produced.
b. Revisions Regarding Nature of Hazards To Be Evaluated
    The hazard analysis provisions in both the FSVP and preventive 
controls previously proposed rules would have required evaluation of 
hazards that are reasonably likely to occur. As we state

[[Page 58580]]

in the Preventive Controls supplemental document, we acknowledge that 
it might be confusing to use the phrase ``reasonably likely to occur'' 
in both our HACCP regulations and in the preventive controls and FSVP 
regulations, because the phrase ``reasonably likely to occur'' has been 
used as the basis for determining hazards that need to be addressed in 
a HACCP plan at critical control points. In light of this concern, and 
consistent with our revision of the hazard analysis provisions in the 
preventive controls proposed rule, we tentatively conclude that the 
potential hazards that importers should be required to consider in 
their risk analyses are hazards that are known or reasonably 
foreseeable rather than hazards that are reasonably likely to occur. We 
believe that it is appropriate to align the hazard analysis provisions 
in the FSVP regulations with those in the proposed preventive controls 
regulations because hazard analysis is an import component of supplier 
verification.
    We now propose to define a ``known or reasonably foreseeable 
hazard'' as a potential biological, chemical (including radiological), 
or physical hazard that is known to, or has the potential to be, 
associated with a food or the facility in which it is manufactured/
processed (Sec.  1.500 in the revised regulatory text). (We accordingly 
propose to add a definition of ``facility,'' which would be defined as 
a domestic facility or a foreign facility that is required to register 
under section 415 of the FD&C Act (21 U.S.C. 350d), in accordance with 
the requirements of 21 CFR part 1, subpart H.) We also are revising the 
hazard analysis provisions to make clear that they apply to analysis of 
known or reasonably foreseeable hazards.
    Section 1.504(a) in the revised regulatory text would require an 
importer to analyze the known or reasonably foreseeable hazards in a 
food, based on experience, illness data, scientific reports, and other 
information, to determine whether they are ``significant'' hazards. We 
propose to define a ``significant hazard'' as a known or reasonably 
foreseeable hazard 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 and corrective actions, 
verification, and records), as appropriate to the food, the facility, 
and the control (Sec.  1.500 in the revised regulatory text). This 
means that importers must conduct hazard analyses to determine whether 
any known or reasonably foreseeable hazard in a food poses such a risk 
to health that it is necessary to establish controls to significantly 
minimize or prevent the hazard. This definition of significant hazard 
and the proposed requirement to determine whether known or reasonably 
foreseeable hazards are significant are consistent with the approach 
that we are proposing in the supplier program provisions of the 
preventive controls regulations.
2. Biological Hazards
    As previously stated, previously proposed Sec.  1.505(b)(1) would 
require importers to consider whether there are biological hazards in 
the food they import, including microbiological hazards such as 
parasites and environmental pathogens, and other microorganisms of 
public health significance. In the Preventive Controls supplemental 
document, we are replacing the phrase ``microorganism of public health 
significance'' in the proposed preventive controls hazard analysis 
provisions with the phrase ``pathogen'' and proposing to define 
``pathogen'' as a microorganism of public health significance. To 
better align the FSVP requirements with those proposed for preventive 
controls, we are proposing to describe biological hazards in the same 
way in Sec.  1.504(b)(1)(i) in the revised regulatory text and adding a 
definition of ``pathogen'' to proposed Sec.  1.500. In addition, we are 
including the same revised definition of ``environmental pathogen'' as 
is set forth in the Preventive Controls supplemental document, which 
proposes to define ``environmental pathogen'' as a pathogen that is 
capable of surviving and persisting within the manufacturing, 
processing, packing, or holding environment such that food may be 
contaminated and may result in foodborne illness if that food is 
consumed without treatment to significantly minimize or prevent the 
environmental pathogen (the definition also specifies that spores of 
pathogenic sporeformers are not environmental pathogens).
3. Radiological Hazards
    As previously stated, the proposed rule included radiological 
hazards among the types of hazards (along with biological, chemical, 
and physical hazards) that importers must consider in their hazard 
analyses.
a. Comments
    Some comments maintain that radiological hazards should be included 
among the chemical hazards rather than in a separate category. One 
comment states that treating radiological hazards as a separate 
category would mean that FSMA regulations would differ from Codex and 
world-wide HACCP standards, which require evaluation only of 
biological, chemical, and physical hazards, and would create a 
potential for misunderstanding and lack of acceptance by foreign 
suppliers. The comment states that making radiological hazards a subset 
of chemical hazards would help mitigate concerns about a requirement to 
consider radiological hazards.
b. Revisions Regarding Radiological Hazards
    We tentatively conclude that it is appropriate to consider 
radiological hazards as a type of chemical hazard. Therefore, we have 
revised the definition of ``hazard'' and the reference to radiological 
hazards in the revised hazard analysis provisions (Sec. Sec.  1.500 and 
1.504(b)(1)(ii), respectively, in the revised regulatory text). 
However, this does not mean that consideration of radiological hazards 
would be optional; rather, importers would be required to review such 
hazards when considering possible chemical hazards in a food.
4. Intentional Hazards
    In the previous FSVP proposed rule, we stated our tentative 
conclusion that importers need only consider those hazards that occur 
naturally or might be unintentionally introduced (78 FR 45730 at 
45749). We noted that we planned to address the issue of certain 
intentionally introduced hazards as part of our rulemaking to implement 
section 106 of FSMA, which directs FDA to issue regulations to protect 
against the intentional adulteration of food. But we acknowledged that 
some kinds of intentional adulterants could be viewed as reasonably 
likely to occur, such as in foods for which there is a known risk of 
economically motivated adulteration. Therefore, we requested comment on 
whether to include in the FSVP requirements potential hazards that may 
be intentionally introduced for economic reasons.
a. Comments
    Comments were submitted both for and against requiring importers to 
consider hazards intentionally introduced for economic reasons. One 
comment states that although importers should consider economically 
motivated adulterants, most such adulterants should not be regarded as 
reasonably likely to occur and do not pose a food safety hazard. Some

[[Page 58581]]

comments question the feasibility of determining which economically 
motivated adulterants should be viewed as reasonably likely to occur. 
Some comments state that economically motivated adulteration is best 
addressed through food defense plans. One comment states that importers 
should not be required to consider intentional hazards, including 
economically-motivated hazards, because such hazards require different 
kinds of preventive measures than those traditionally used in supplier 
verification programs.
b. Revisions Regarding Intentional Hazards
    We are proposing to add hazards that may be intentionally 
introduced for purposes of economic gain to the types of known or 
reasonably foreseeable hazards that an importer would be required to 
consider in its hazard analysis (see Sec.  1.504(b)(2)(iii) in the 
revised regulatory text). As discussed in the Preventive Controls 
supplemental document, several substances, such as melamine and dyes 
containing lead, have been used in economically motivated adulteration 
schemes and have potential to harm public health. Because some 
economically motivated adulterants should be regarded as known or 
reasonably foreseeable hazards, we believe it is appropriate that 
importers consider them when conducting hazard analyses. We are no 
longer proposing that importers analyze hazards that are reasonably 
likely to occur, so the concerns related to applying that standard to 
economically motivated adulterants are no longer relevant. In addition, 
because the proposed regulations define a ``hazard'' as an agent that 
is reasonably likely to cause illness or injury in the absence of its 
control, importers need only consider those economically motivated 
adulterants that are reasonably likely to harm consumers' health, not 
economically motivated adulterants that solely affect quality or value.
    We disagree with the comment that economically motivated 
adulteration requires different kinds of preventive measures than those 
traditionally used in supplier verification programs. Industry 
currently uses audits, sampling, and testing to verify that hazards are 
being controlled, including hazards from economic adulteration. 
Nevertheless, as discussed in section II.C.5, the revised proposed 
supplier verification requirements provide considerable flexibility to 
importers in conducting supplier verification, including the ability to 
determine and implement any appropriate supplier verification activity 
based on the risks associated with the food and foreign supplier.
5. Environmental Pathogens in Certain Ready-To-Eat Food
    To better align the hazard analysis requirements in the FSVP 
regulations with those in the proposed preventive controls regulations, 
we are adding a proposed requirement, in Sec.  1.504(c)(2) in the 
revised regulatory text, for importers to include in their hazard 
analysis of a food an evaluation of environmental pathogens whenever a 
ready-to-eat food is exposed to the environment before packaging and 
the packaged food does not receive a treatment that would significantly 
minimize the pathogen.
6. Factors Affecting the Safety of Finished Food
    Also to better align the FSVP hazard analysis requirements with 
those in the proposed preventive controls regulations, we are making 
two minor revisions to the list of proposed items that importers must 
consider regarding their potential effect on the safety of finished 
food for the intended consumer. In Sec.  1.504(c)(3)(i) in the revised 
regulatory text, we are replacing ``ingredients of the food'' with 
``formulation of the food,'' and in Sec.  1.504(c)(3)(iii) in the 
revised regulatory text we are adding a requirement to consider ``raw 
materials and ingredients.''

C. Supplier Verification

    We are revising several aspects of the proposed requirements 
concerning foreign supplier verification procedures and related 
activities. The revisions include a revised proposal regarding the 
alternative options presented in the proposed rule concerning 
appropriate supplier verification activities when foreign suppliers 
control (or verify control of) hazards in food.
1. List of Foreign Suppliers
    To help ensure that importers are obtaining food only from 
appropriate foreign suppliers, previously proposed Sec.  1.506(a) would 
require each importer to maintain a written list of the foreign 
suppliers from which they are importing food. The list would also help 
importers to quickly and accurately identify their foreign suppliers 
for purposes of conducting FSVP activities such as supplier 
verification, investigations, and corrective actions, and help ensure 
consistent performance of these activities by importers' employees or 
other qualified individuals.
a. Comments
    Several comments express support for the proposed requirement that 
importers maintain a list of their foreign suppliers. However, some 
comments oppose this requirement on the basis that it would present 
logistical or administrative challenges. Some comments state that it 
would be burdensome to constantly update the list of foreign suppliers. 
Some comments suggest that importers instead be required to provide a 
list of suppliers upon the Agency's request. One comment states that 
the identity of suppliers is confidential business information that 
importers should not be required to disclose to FDA on a routine basis.
    Some comments state that some importers might not maintain a single 
list of approved suppliers but use a corporate-wide or centralized 
system to confirm receipt of food from approved suppliers. These 
comments instead recommend that importers be required to establish a 
system that will allow them to confirm that imported food is from a 
foreign supplier that the importer has approved for use.
    One comment states that in emergency situations to avoid production 
disruptions, an importer might need to obtain food from foreign 
suppliers that they have not audited. The comment maintains that use of 
food from such suppliers would be acceptable provided that the food is 
inspected or analyzed before use.
b. Revisions Regarding Process for Confirming Receipt of Food From 
Approved Suppliers.
    We are uncertain how an importer could verify that a food it 
receives is from an approved foreign supplier yet be unable to generate 
a list of such approved suppliers, especially when the importer uses a 
centralized, corporate-wide system. We understand that use of multiple 
supplier databases could necessitate some compilation procedure, but it 
does not appear to us that this would be significantly burdensome. 
Nevertheless, we tentatively conclude that requiring importers to 
establish a system or procedure to confirm that imported foods are from 
approved suppliers, rather than maintain a list of foreign suppliers, 
would enhance the safety of imported food at least as much as merely 
maintaining a list of suppliers while reducing the apparent 
administrative burden on importers. Therefore, we have replaced the 
proposed requirement to maintain a list of foreign suppliers with a 
proposed requirement, in Sec.  1.506(a) in the revised

[[Page 58582]]

regulatory text, to establish and follow written procedures to ensure 
that foods are imported from foreign suppliers the importer has 
approved based on the risk evaluation it conducts under Sec.  1.505 and 
to document use of these procedures. These procedures might address 
approval of suppliers, approval or rejection of particular shipments of 
foods, and documentation of receipt from approved suppliers. It is 
essential that such procedures be capable of accurately identifying 
foreign suppliers for purposes of meeting FSVP requirements.
    However, we believe that, in limited circumstances, it might be 
appropriate for an importer to use a supplier for which the importer 
has not completed a full risk evaluation provided that the importer 
takes other steps to ensure that food from such a supplier is safe. For 
example, because of a problem with a long-time supplier due to an 
equipment breakdown, an environmental or weather-related crisis (e.g., 
severe drought or flooding), or some other unexpected circumstance, it 
might be necessary for an importer to obtain a food on a temporary 
basis from a new supplier. Because the importer would be unable to 
immediately fully evaluate the potential supplier, the importer would 
need to take other steps to verify that the food obtained from that 
supplier was safe. Such verification measures might include sampling 
and testing individual shipments from the supplier. Therefore, revised 
Sec.  1.506(a) would permit the use of unapproved foreign suppliers on 
a temporary basis when necessary and appropriate, provided that the 
importer subjects the food from such suppliers to adequate verification 
activities before using or distributing the food. The importer's 
written procedures regarding the use of approved suppliers also would 
need to address the circumstances under which unapproved suppliers 
might be used, and the importer would need to document the verification 
activities it conducts when using unapproved suppliers. We request 
comment on circumstances under which it might be necessary and 
appropriate to receive food from unapproved foreign suppliers and on 
the types of verification activities that an importer should conduct on 
food from an unapproved supplier.
2. Purpose of Supplier Verification
    Section 1.506(c) of the 2013 proposed rule would have required the 
importer to conduct foreign supplier verification activities to provide 
adequate assurances that the hazards the importer had identified as 
reasonably likely to occur were adequately controlled. However, we 
tentatively concluded that this provision should not apply to 
microbiological hazards in RACs that are fruits or vegetables and that 
would be subject to the produce safety regulations in proposed part 112 
(21 CFR part 112) because importers of these fruits or vegetables would 
not be required to conduct a hazard analysis regarding the 
microbiological hazards in this food. Instead, proposed Sec.  1.506(h) 
stated that verification for these hazards should address whether 
foreign suppliers are producing these fruits and vegetables in 
accordance with the produce safety regulations.
a. Comments
    One comment maintains that directing that supplier verification 
activities be designed to provide assurances that hazards are 
adequately controlled is inconsistent with the statute and does not 
focus on the key issues affecting the safety of imported food. The 
comment states that supplier verification activities should consider 
not just the hazards in food but supplier-related risks. Some comments 
maintain that linking supplier verification activities solely to food 
hazards incorrectly implies that verification controls the hazard and 
suggests that the supplier can pose no significant safety risks.
b. Revisions Regarding Purpose of Supplier Verification
    We do not believe, nor does the preamble to the 2013 proposed rule 
state, that supplier verification activities actually control hazards. 
Rather, a key purpose of verification is to provide assurance that 
hazards are being effectively controlled by the foreign supplier or 
some other entity. However, as stated in section II.A.2, we tentatively 
conclude that importers should consider both food and supplier risks in 
determining what supplier verification activities to conduct. In 
accordance with this approach, we believe that the purpose of supplier 
verification activities should not be limited to verifying control of 
hazards. Therefore, we now propose to require (in Sec.  1.506(c) in the 
revised regulatory text) that supplier verification activities provide 
adequate assurances that the 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 
or 419 of the FD&C Act (the preventive controls and produce safety 
provisions, respectively), if either is applicable, and is producing 
the food in compliance with sections 402 and 403(w) of the FD&C Act. 
This more directly links supplier verification activities to the 
statutory purpose for FSVPs in section 805(a)(1) of the FD&C Act.
    With this change to the proposed purpose of supplier verification 
activities, we tentatively conclude that there is no need for a 
separate requirement concerning supplier verification activities 
related to microbiological hazards in RACs that are fruits or 
vegetables subject to the produce safety regulations. With respect to 
microbiological hazards in such food, under revised Sec.  1.506(c), the 
importer of the food would need to conduct activities to verify that: 
(1) The foreign supplier is using processes and procedures that provide 
at least the same level of protection as those required under the 
produce safety regulations, when finalized and (2) the food is not 
adulterated or misbranded regarding allergen labeling.
3. No Hazards Identified
    Under Sec.  1.506(d) of the previous proposed rule, if an importer 
determines that no hazards are reasonably likely to occur with a food, 
the importer would not be required to conduct supplier verification 
activities. However, under the supplier program provisions in the 
revised preventive controls proposal, when there are no significant 
hazards in a raw material or ingredient, the receiving facility would 
not be required to have a supplier program for the food, including the 
requirement to determine appropriate verification activities by 
considering food and supplier risks. To better align the proposed FSVP 
regulations with the proposed preventive controls regulations, we 
propose to specify, in Sec.  1.504(f) in the revised regulatory text, 
that if an importer evaluates the known and reasonably foreseeable 
hazards in a food and determines that there are no significant hazards, 
the importer would not be required to determine what foreign supplier 
verification and related activities it should conduct and would not be 
required to conduct any such activities. (As under the proposed rule, 
revised Sec.  1.504(f) states that this exemption would not apply if 
the food is a RAC that is a fruit or vegetable and that is subject to 
the produce safety regulations.)
4. Hazards Controlled by the Importer or Its Customer
    The preamble to the 2013 proposed rule noted that some hazards 
associated with an imported food are controlled through actions that 
the importer or its customer takes after the food is brought into the 
United States. We tentatively

[[Page 58583]]

concluded that if an importer or its customer has established validated 
preventive controls to ensure that a hazard is adequately controlled 
through processing in the United States, there would be no need for the 
importer to conduct a foreign supplier verification activity with 
respect to that hazard (78 FR 45730 at 45752). Therefore, when an 
importer is adequately controlling a hazard that it has identified, 
proposed Sec.  1.506(e) would have required the importer to document, 
at least annually, that it had established and was following procedures 
that adequately controlled the hazard. Similarly, when an importer's 
customer was controlling a hazard, proposed Sec.  1.506(f) would have 
required the importer to document that its customer controlled the 
hazard by obtaining written assurance, at least annually, from the 
customer that it had established and was following procedures 
(identified in the written assurance) that adequately controlled the 
hazard.
    However, we also requested comment on whether it would be 
appropriate to deem importers who are in compliance with any applicable 
supplier verification provisions that are included in the preventive 
controls regulations to be in compliance with the FSVP requirements, to 
avoid duplicative regulation of importers who are also registered with 
FDA as food facilities. We tentatively concluded that, if a provision 
to this effect were included in the FSVP regulations, proposed Sec.  
1.506(e) would be unnecessary, as importers that control hazards in 
foods they import would be subject to the supplier verification 
provisions in the preventive controls regulations (78 FR 45730 at 
45752). Similarly, we tentatively concluded that proposed Sec.  
1.506(f) would be unnecessary if the FSVP regulations were to include a 
provision stating that an importer whose customer was in compliance 
with any adopted preventive controls supplier verification provisions 
was deemed to be in compliance with the FSVP requirements. We requested 
comment on this proposed approach to supplier verification when the 
importer or its customer controls a hazard.
a. Comments
    Several comments agree with proposed Sec.  1.506(e) requiring 
importers who control hazards in food they import to document their 
control of these hazards. In addition, several comments express support 
for avoiding imposing redundant verification requirements on importers 
that would be required to conduct supplier verification under the 
preventive controls regulations. One comment agrees that proposed Sec.  
1.506(e) would be unnecessary if importers who were in compliance with 
supplier verification provisions in the preventive controls regulations 
were deemed in compliance with the FSVP requirements.
    One comment states that supplier verification activities should not 
turn on the entity that is controlling a hazard in a food. The comment 
states that verification activities may be needed even when the foreign 
supplier does not control the hazard, adding that importers should not 
be required to engage in a paperwork exercise to obtain assurances of 
their customers' food safety controls. Similarly, another comment 
opposes not requiring standard verification activities when a hazard is 
to be controlled by the importer or its customer, maintaining that 
nearly all suppliers should be subject to verification activities. The 
comment states that not requiring any supplier verification would 
overlook important issues such as the supplier's compliance with CGMP 
requirements and the need for programs to avoid introducing any 
unforeseen hazards. The comment also states that the proposal is 
problematic because the intended use of the food may not be known at 
the time of entry or different parts of a product batch might be 
destined for different customers with different processes. However, 
elsewhere in its submitted comments, the commenter maintains that FDA 
must harmonize the supplier verification provisions in the preventive 
controls regulations with the FSVP regulations so that imported 
ingredients need only be verified once.
b. Revisions Regarding Importers Subject to the Supplier Program 
Provisions in the Preventive Controls Regulations
    As stated previously in this document, elsewhere in this issue of 
the Federal Register we are proposing a potential requirement for a 
supplier program in the proposed preventive controls regulations. 
Therefore, consistent with the discussion in the 2013 FSVP proposed 
rule, we propose to specify, in Sec.  1.502(c) in the revised 
regulatory text, that if an importer is required to establish and 
implement a risk-based supplier program under the preventive controls 
regulations (for either human or animal food), and the importer is in 
compliance with those requirements, the importer would be deemed in 
compliance with the FSVP regulations (except for the requirement to 
identify the importer at entry of the food into the United States). 
Similarly, under Sec.  1.502(d) in the revised regulatory text, if an 
importer's customer is required to establish and implement a risk-based 
supplier program under the preventive controls regulations (for either 
human or animal food), and the importer annually obtains written 
assurance that its customer is in compliance with those requirements, 
the importer would be deemed in compliance with the FSVP regulations 
(except for the requirement to identify the importer at entry of the 
food into the United States and the requirement to maintain records of 
the written assurances). Because the importer or its customer would be 
performing supplier verification activities under the preventive 
controls regulations, we tentatively conclude that this approach 
addresses concerns about a lack of supplier verification when the 
importer or its customer controls a hazard, while also avoiding 
imposing redundant verification requirements.
    However, even though we are proposing to add these provisions 
regarding importers who are facilities that are subject to the supplier 
program requirements in the preventive controls regulations, we 
tentatively conclude that it would not be appropriate to delete the 
previously proposed provisions concerning foods with hazards to be 
controlled by the importer or its customer. The reason for this is that 
we tentatively conclude that it is appropriate to align the FSVP 
requirements with the potential supplier program provisions discussed 
in the preventive controls proposed rule, should they be adopted. The 
potential supplier program requirements would not apply under the 
following circumstances:
     When the preventive controls at the receiving facility are 
adequate to significantly minimize or prevent each of the significant 
hazards in a raw material or ingredient; or
     When the receiving facility relies on its customer to 
control the hazard and annually obtains from its customer written 
assurance that the customer has established and is following procedures 
(identified in the written assurance) that will significantly minimize 
or prevent the hazard.
    In such circumstances, requiring an importer that also is a 
facility subject to the preventive controls regulations to conduct 
foreign supplier verification activities would not impose a redundant 
regulatory burden because such importer-facilities would not also be 
subject to the preventive controls supplier program requirements. 
Nevertheless, we tentatively conclude that it still would impose an

[[Page 58584]]

unnecessary burden because the importer's (and/or its customer's) 
control of all significant hazards in the food would effectively 
resolve the food safety concerns that supplier verification is intended 
to address. Therefore, we propose to specify, in Sec.  1.504(g) of the 
revised regulatory text (in the hazard analysis section of the proposed 
FSVP regulations), that if the preventive controls that an importer 
and/or its customer implements under the preventive controls 
regulations are adequate to significantly minimize or prevent all 
significant hazards in a food, the importer is not required to 
determine appropriate foreign supplier verification and related 
activities under Sec.  1.505 and is not required to conduct such 
activities under Sec.  1.506. Proposed Sec.  1.504(g) further states 
that if the importer's customer controls one or more significant 
hazards in a food, the importer 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.
5. Hazards Controlled by the Foreign Supplier
    The previous proposed rule set forth two options for the 
requirements regarding supplier verification activities for hazards 
that are controlled, or for which control is verified, by the 
importer's foreign supplier (see previously proposed Sec.  1.506(g), 
Options 1 and 2). Option 1 would have established certain requirements 
for SAHCODHA hazards to be controlled by the foreign supplier, and 
different requirements for non-SAHCODHA hazards and SAHCODHA hazards 
that the foreign supplier verified had been controlled by its raw 
material or ingredient supplier. (The preamble to the 2013 proposed 
rule described a SAHCODHA hazard as one for which a recall of a 
violative product posing such hazard is designated as ``Class I'' under 
21 CFR 7.3(m)(1).) Option 2 would have required the importer to 
determine the supplier verification activity it would use for all 
hazards that the foreign supplier controlled or for which it verified 
control.
    Under Option 1, for a SAHCODHA hazard that was to be controlled at 
the foreign supplier's establishment, the importer would have been 
required to conduct and document certain initial and subsequent 
periodic (at least annual) onsite audits of the foreign supplier. 
Onsite auditing also would be required under Option 1 for 
microbiological hazards in certain RACs that are fruits or vegetables. 
When onsite auditing alone could not provide adequate assurances that 
such a hazard was adequately controlled, the importer would have had to 
conduct one or more additional verification activities to provide such 
assurances. For non-SAHCODHA hazards to be controlled by the foreign 
supplier and all hazards for which the supplier verified control by its 
raw material or ingredient supplier, Option 1 would have required that 
the importer conduct, upon consideration of the risk presented by the 
hazard and the food and foreign supplier's compliance status, one or 
more of the following verification activities before using or 
distributing the food and periodically thereafter:
     Onsite auditing of the foreign supplier.
     Periodic or lot-by-lot sampling and testing of the food.
     Review of the foreign supplier's food safety records.
     Any other procedure established as being appropriate based 
on the risk associated with the hazard.
    On the other hand, Option 2 would have allowed the importer to 
determine, for all hazards either controlled by the foreign supplier or 
for which the foreign supplier verified control by its supplier, which 
of the previously listed verification activities would be appropriate 
to verify that the hazard was adequately controlled. In determining the 
appropriate verification activities and how frequently they should be 
conducted, Option 2 would have required the importer to consider the 
risk presented by the hazard, the probability that exposure to the 
hazard would result in serious adverse health consequences or death to 
humans or animals, and the food and foreign supplier's compliance 
status.
a. Comment
    We received many comments in support of Option 1 and many that 
favor Option 2. Comments in favor of Option 1 include the following:
     Option 1 would provide greater protection to consumers 
than Option 2.
     Option 1 is risk-based in that it would require the most 
rigorous form of supplier verification--onsite auditing--when the most 
serious hazards are present in food.
     Option 2 would provide too much discretion to importers, 
who would have an incentive to choose lower-cost and less effective 
verification methods, which could result in an increase in contaminated 
imported food.
     A single, streamlined requirement would be more easily 
enforced without confusion, and regulated entities often prefer such 
clarity.
     Option 1 would reduce industry costs by avoiding the need 
for importers to make verification decisions on a product-by-product 
basis.
    Comments in favor of Option 2 include the following:
     Option 2 would provide importers with the flexibility 
needed to tailor the supplier verification to the particular food and 
supplier risk.
     Option 2 is more closely aligned with current industry 
practice, which often uses onsite audits but also relies on other 
verification methods depending on food and supplier risk.
     Option 2 is more risk-based and would result in a better 
allocation of resources by not requiring onsite auditing when it would 
not be justified by risk.
     Requiring different supplier verification activities for 
different types of hazards in a food is inconsistent with current 
industry practice.
     Option 1 could lead importers to simply ``check the box'' 
that a foreign supplier has been audited rather than analyze the audit 
results and consider whether additional verification activities are 
needed.
     The SAHCODHA standard is not well understood and might not 
be workable as a factor for determining supplier verification 
activities.
    One comment recommends what it describes as a hybrid of the two 
options. The comment suggests that annual onsite auditing should be the 
default requirement for SAHCODHA hazards and for microbiological 
hazards for RACs that are fruits or vegetables, but an importer would 
be permitted to use alternative verification measures if it could 
justify, based on a comprehensive risk assessment, that risks are 
reduced and that the alternative measures would adequately verify that 
the foreign supplier adequately controlled the hazards.
b. Revisions Regarding Supplier Verification Activities
    Although we acknowledge the concerns regarding Option 2 expressed 
by supporters of Option 1, we tentatively conclude that allowing 
importers the flexibility to determine the appropriate supplier 
verification activity (or activities) based on the importer's 
evaluation of food and supplier risks would be a more risk-based 
approach. We believe that this would more closely align the 
verification requirements with Congress's directive that importers 
perform risk-based verification activities. In turn, this should result 
in safer imported food by allowing importers to optimize their 
verification

[[Page 58585]]

efforts in accordance with the relative risks to public health posed by 
different foods and suppliers.
    Therefore, we are proposing, in Sec.  1.506(d)(1) in the revised 
regulatory text, that importers be required to conduct and document one 
or more of four supplier verification activities--onsite auditing, 
sampling and testing of food, review of the foreign supplier's food 
safety records, or some other appropriate risk-based verification 
activity--before initially importing a food and periodically 
thereafter. The importer would be required to determine and document 
which verification activity or activities are appropriate, as well as 
the frequency with which the activities must be conducted, based on the 
risk evaluation that the importer conducts for the food and supplier 
under proposed Sec.  1.505. As in both Option 1 and Option 2 under the 
previous proposed rule, the revised proposal recognizes that for some 
foods or foreign suppliers it might be necessary to conduct more than 
one verification activity to provide the required assurances (see Sec.  
1.506(d)(3) in the revised regulatory text).
    The revised proposal states that an onsite audit of a foreign 
supplier must be conducted by a qualified auditor (Sec.  
1.506(d)(1)(i)(A) in the revised regulatory text), who is defined as a 
person who is a qualified individual and has technical expertise 
obtained by a combination of training and experience appropriate to 
perform the auditing function (Sec.  1.500 in the revised regulatory 
text). (The proposed definition also specifies that a foreign 
government employee could be a qualified auditor.) The revised proposal 
also states that sampling and testing of a food may be conducted by 
either the importer or the foreign supplier (Sec.  1.506(d)(1)(ii)(A) 
in the revised regulatory text).
    We are proposing a slight modification to this general rule 
regarding verification activities in the case of foods with SAHCODHA 
hazards, similar to the ``hybrid'' approach suggested by one comment. 
As expressed by some Option 1 supporters, we believe that requiring 
onsite auditing when there is a SAHCODHA hazard in a food is risk-based 
because it would require what is arguably the most robust supplier 
verification activity--annual onsite auditing--for the most serious 
hazards in foods. However, we acknowledge the possibility that: (1) Use 
of some other verification activity, (2) less frequent onsite auditing, 
or (3) some combination of those two approaches could provide adequate 
assurances regarding the safety of the food. We also recognize that 
although some importers might prefer the ease of not having to make a 
determination of appropriate supplier verification activities when a 
SAHCODHA hazard is present in a food, others would prefer being able to 
tailor verification activities (and the frequency with which they are 
conducted) to a particular food and supplier risk profile.
    For these reasons, we are proposing to require, in Sec.  
1.506(d)(2) in the revised regulatory text, that when a SAHCODHA hazard 
in a food will be controlled by the foreign supplier, the importer must 
conduct (or obtain documentation of) initial and subsequent annual 
onsite auditing of the foreign suppler unless the importer determines 
that other supplier verification activities and/or less frequent onsite 
auditing are appropriate to provide adequate assurances regarding the 
safety of a particular food and foreign supplier based on the risk 
evaluation conducted under Sec.  1.505. This would provide importers 
with the certainty of knowing that use of initial and subsequent annual 
onsite auditing would satisfy the verification requirement when a 
SAHCODHA hazard is present in a food, while allowing importers to use 
an alternative verification mechanism(s) if they determine that such 
mechanism(s) provide adequate safety assurances.
    We do not believe, as some comments suggest, that making onsite 
auditing mandatory when there is a SAHCODHA hazard in a food or, in the 
case of our revised proposal, establishing onsite auditing as the 
``default'' verification activity in such circumstances, would result 
in importers failing to analyze audit results or consider whether 
additional verification activities are needed. Both the previous 
proposed rule (Sec.  1.506(g)(5) under Option 1) and the revised 
proposal (Sec.  1.506(d)(6) in the revised regulatory text) would 
require importers to promptly review the results of their verification 
activities and, if necessary, take appropriate corrective action. In 
addition, under both the previous proposed rule (Sec.  1.506(g)(1) 
under Option 1) and the revised proposal (Sec.  1.506(d)(3) in the 
revised regulatory text), even when an importer conducts an onsite 
audit or obtains an onsite audit report to verify control of a SAHCODHA 
hazard in a food, it might be necessary in some circumstances for the 
importer to conduct some additional verification.
    We also do not believe that purported uncertainty about the 
SAHCODHA standard would make it difficult for importers to comply with 
this provision. FDA's Reportable Food Registry Questions and Answers 
document discusses the types of violative products that should be 
addressed through a Class I recall, which uses the SAHCODHA standard. 
In addition, the Agency's weekly FDA Enforcement Report, which is 
available at FDA's Web site (http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm), provides more information about foods 
that have been the subject of a Class I recall and the reasons for the 
recall. We will consider providing additional guidance to industry to 
help clarify what food hazards constitute SAHCODHA hazards under the 
FSVP regulations.
    We acknowledge that there may be concerns that the revised proposed 
approach to foreign supplier verification activity requirements could 
lead some importers to rely on verification activities that might be 
inadequate to provide sufficient assurances about the safety of the 
imported food. We believe that there are some circumstances, such as 
when a SAHCODHA hazard is present in a food, in which onsite auditing 
on an annual basis likely would be needed to ensure proper verification 
of suppliers. However, in some cases, including even when a SAHCODHA 
hazard is present, we believe it is possible that alternative supplier 
verification activities would provide adequate assurances of food 
safety. An importer who chose to conduct such an alternative activity 
would need to maintain documentation that the activity provides 
adequate assurances of safety; this documentation would be available 
for FDA review during any inspection of the importer. To address 
concerns that the revised proposal may allow too much discretion, and 
to assist importers in meeting the verification requirements, we 
anticipate that we will provide guidance to industry on the 
circumstances (incorporating both food and supplier risks) under which 
onsite auditing of foreign suppliers and/or other supplier verification 
approaches are appropriate for providing adequate assurances regarding 
the safety of the food produced by a foreign supplier.
6. Food From Farms That Are Not Covered Farms Under the Proposed 
Produce Safety Regulations
    In addition to the just-discussed revisions concerning supplier 
verification activities, we are proposing to include a revision 
regarding food from foreign suppliers that are farms but not ``covered 
farms'' subject to the produce safety regulations. We are making this 
change to reflect the different treatment of food from such farms under 
the proposed produce

[[Page 58586]]

safety regulations and to be consistent with the potential requirement 
for a supplier program in the proposed preventive controls regulations.
    Under Sec.  1.506(d)(4) in the revised regulatory text, if a 
foreign supplier of a food is a farm that is not subject to the 
requirements in part 112 (the produce safety regulations) in accordance 
with Sec.  112.4 regarding the food being imported, the importer would 
not be subject to the FSVP supplier verification activity requirements 
in revised Sec.  1.506(d)(1) and (d)(2) if the importer:
     Documented, at the end of each calendar year, that the 
food provided by the foreign supplier was not subject to part 112; and
     obtained written assurance, at least every 2 years, that 
the foreign supplier was producing the food in compliance with the FD&C 
Act.
    These alternative verification requirements would apply to 
importers of food from the following:
     Farms that do not grow and harvest ``produce,'' as defined 
in Sec.  112.3(c) of the proposed produce safety regulations. For 
example, because food grains are not produce, the alternative 
verification requirements would apply to importers of food grain.
     Farms that grow and harvest produce that is not covered by 
the proposed produce safety regulations in accordance with proposed 
Sec.  112.1. Such ``non-covered produce'' includes produce that is 
rarely consumed raw, produce that is produced for personal consumption 
or for consumption on the farm or another farm under the same 
ownership, and produce that is not a RAC.
     Farms that are not ``covered farms'' because they produce 
an average annual monetary value of produce of no more than $25,000 
(see proposed Sec.  112.4(a)).
     Farms that are not covered farms because they satisfy the 
requirements for a qualified exemption from the proposed produce safety 
regulations under proposed Sec.  112.5 (including requirements 
concerning direct sale to qualified end-users) and the exemption has 
not been withdrawn.
    Because FDA has determined that these farms either: (1) Should not 
be subject to the produce safety regulations or (2) should not be 
required to comply with the ``standard'' requirements applicable to 
covered activities conducted for covered produce, we tentatively 
conclude that it is appropriate to similarly not require importers of 
food from such farms to conduct the ``standard'' supplier verification 
activities. We request comment on the proposed alternative method of 
supplier verification of obtaining written assurance of compliance with 
the FD&C Act by these farms.
7. Documentation of Foreign Supplier Verification Activities
    The proposed rule does not specify what documentation of onsite 
audits of foreign suppliers importers must maintain. At the public 
meetings on the FSVP proposed rule and in other meetings with 
stakeholders, we invited comment on what documentation of onsite audits 
importers should be required to have. We also stated that for onsite 
audits conducted for FSVP purposes, importers would not be required to 
obtain a regulatory audit report as required for audits conducted by 
accredited auditors/certification bodies under FDA's proposed rule on 
``Accreditation of Third-Party Auditors/Certification Bodies to Conduct 
Food Safety Audits and to Issue Certifications'' (78 FR 45782, July 29, 
2013).
    With respect to documentation of sampling and testing of an 
imported food, the proposed rule (Sec.  1.506(g)(2)(ii) under Option 1) 
specified a certificate of analysis (COA) containing the results of 
testing as an example of appropriate documentation but did not require 
a particular form or forms of documentation. The preamble to the 
proposed rule suggested certain information that might be included in a 
COA (78 FR 45730 at 45757). Similarly, the proposed rule (Sec.  
1.506(g)(2)(iii) under Option 1) included records of a foreign 
supplier's audit of its supplier's hazard control activities as an 
example of appropriate documentation of review of a foreign supplier's 
food safety records but did not require a specific form of 
documentation. The preamble to the proposed rule states that food 
safety records are records documenting that the hazard control 
procedures established by the supplier are being followed and are 
adequately controlling the hazards (78 FR 45730 at 45756). The proposed 
rule provided no example of appropriate documentation of other 
verification procedures determined by the importer to be appropriate.
a. Comments
    Several comments state that importers should not be required to 
share foreign supplier audit reports with FDA. The comments state that 
because such reports often include confidential business information 
and findings of flaws in safety systems, requiring that the reports be 
made available to the Agency might make suppliers less likely to allow 
audits or result in less robust audits. Some comments suggest that 
importers be required to maintain documentation that an audit was 
conducted (the date of the audit and the name of the auditor) and 
documentation of the completion of any corrective actions in response 
to significant deficiencies.
    Regarding documentation of sampling and testing, one comment 
encourages us not to specify requirements for the content of COAs 
because this could change over time and is better left to industry to 
determine.
b. Revisions Regarding Documentation of Supplier Verification 
Activities
    We acknowledge the concerns about requiring importers to document 
onsite audits of foreign suppliers with the full reports of those 
audits. We do not believe that importers should be required to make 
full audit reports available to us in an FSVP inspection. We understand 
that a foreign supplier might be reluctant to submit to onsite auditing 
if the full report of the audit would be made available to us, and we 
do not believe that we need to review the full audit report to 
determine whether an appropriate audit was conducted and any 
significant problems were corrected. Accordingly, we now are revising 
the proposed provisions regarding onsite auditing of foreign suppliers 
to require importers to retain documentation of the following: 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 (Sec.  1.506(d)(1)(i)(C) in 
the revised regulatory text). We tentatively conclude that this 
requirement would enable us to determine whether an appropriate audit 
of the foreign supplier was conducted and whether the importer used the 
audit results appropriately, while preserving the benefits of the 
confidentiality of the audit reports.
    We also are proposing to specify documentation requirements for 
other supplier verification activities. The revised proposal (Sec.  
1.506(d)(1)(ii)(B) in the revised regulatory text) states that 
documentation of an incidence of sampling and testing (which under 
Sec.  1.506(d)(1)(ii)(A) may be conducted either by the importer or the 
foreign supplier) must include the following: Identification of the 
food tested (including lot number, as appropriate), the number of 
samples tested, the test(s) conducted (including the analytical 
methods(s) used), the date(s) on which the test(s) were conducted, the 
results of

[[Page 58587]]

the testing, any corrective actions taken in response to detection of 
hazards, and information identifying the laboratory conducting the 
testing.
    The revised proposal (Sec.  1.506(d)(1)(iii) in the revised 
regulatory text) states that documentation of each review of foreign 
supplier safety records must include the date(s) of review, any 
corrective actions taken in response to significant deficiencies 
identified during the review, and documentation that the review was 
conducted by a qualified individual.
    The revised proposal does not specify how importers must document 
other appropriate supplier verification activities that they conduct. 
We request comment on whether the regulations should specify the form 
of such documentation and, if so, what form such documentation should 
take.
8. Independence of Qualified Individuals Conducting Verification 
Activities
    The previous proposed rule specifies that a qualified individual 
who conducts any of the supplier verification activities must not have 
a financial interest in the foreign supplier and payment of the 
qualified individual must not be related to the results of the activity 
(proposed Sec.  1.506(g)(6) (under Option 1)). The proposal states that 
this requirement would not prohibit an importer or one of its employees 
from conducting the verification activity. In the preamble to the 2013 
proposed rule, we requested comment on whether and, if so, how the 
regulations should specify what constitutes a financial interest (78 FR 
45730 at 45759).
a. Comments
    Many comments express support for prohibiting persons who conduct 
supplier verification activities from having a financial interest in 
the foreign supplier whose operations they are evaluating, as well as 
support for the ban on linking remuneration to the results of 
verification activity (i.e., payment for a favorable assessment). One 
comment states that we should specify what constitutes a financial 
interest to ensure that audits are not performed by persons with a 
financial interest in the foreign supplier, and requests that we 
provide a standard disclosure form regarding financial interests.
b. Request for Further Comment
    At this time, we are not making any revisions to the proposed 
requirement that persons conducting supplier verification activities 
not have a financial interest in the foreign supplier and that payment 
to such a person must not be related to the results of the activity 
they have performed. However, in the Preventive Controls supplemental 
document, we are requesting comment on whether the potential supplier 
program requirements, should they be included in the final rule, 
include provisions to address the independence of persons who conduct 
supplier verification activities. We ask in that document whether such 
conflict of interest requirements should be directed to a subset of 
persons who conduct verification activities (such as auditors) or 
whether they should encompass all persons who conduct verification 
activities. We also ask whether requirements such as those in the FSVP 
proposed rule would be appropriate or whether we should instead adopt 
different requirements, such as a requirement that persons be free of 
conflicts of interest that are relevant to the outcome of the 
verification activity conducted. In addition, we ask what should 
constitute a financial interest, including whether owning stock in a 
company should constitute a financial interest.
    In light of our statements in the Preventive Controls supplemental 
document, we renew our request for comment on the provisions in the 
FSVP proposed rule on the independence of qualified individuals 
conducting verification activities and invite comment (in the context 
of the FSVP regulations) on the additional conflict of interest issues 
raised in the Preventive Controls supplemental document.

D. Definitions of Very Small Importer and Very Small Foreign Supplier

    The 2013 proposed rule specified certain modified FSVP requirements 
for very small importers and importers of food from very small foreign 
suppliers. Proposed Sec.  1.500 defined a ``very small importer'' as an 
importer, including any subsidiary, affiliate, or subsidiaries or 
affiliates, collectively, of any entity of which the importer is a 
subsidiary or affiliate, whose average annual monetary value of sales 
of food during the previous 3-year period (on a rolling basis) is no 
more than $500,000, adjusted for inflation. Proposed Sec.  1.500 
defined a ``very small foreign supplier'' as a foreign supplier, 
including any subsidiary, affiliate, or subsidiaries or affiliates, 
collectively, of any entity of which the foreign supplier is a 
subsidiary or affiliate, whose average annual monetary value of sales 
of food during the previous 3-year period (on a rolling basis) is no 
more than $500,000, adjusted for inflation.
    We stated in the preamble to the proposed rule that the limitation 
of $500,000 in annual food sales was consistent with the sales 
limitation in the definition of ``qualified facility'' in the 
Preventive Controls proposed rule and ``small business'' in the Produce 
Safety proposed rule. We requested comment on this proposed approach to 
the definitions of very small importer and very small foreign supplier 
(78 FR 45730 at 45744). We also requested comment on whether and, if 
so, how these definitions should take into account the proposed 
definition of ``very small business'' in the Preventive Controls 
proposed rule, for which we posed three alternative dollar-value 
ceilings: $250,000, $500,000, and $1 million.
1. Comments
    Several comments oppose modified requirements for very small 
importers and importers of food from very small foreign suppliers 
regardless of the sales dollar-value ceiling. Reasons specified for 
such opposition include the following: Congress did not exempt very 
small importers from the FSVP requirements; smaller operations may be 
more likely than larger ones to lack adequate verification or control 
systems because they have fewer resources; the effect of the FSVP 
regulations could be undermined if importers and foreign suppliers 
tried to manipulate their facilities or operations to avoid the 
``standard'' requirements; and many small foreign suppliers would 
already be exempt from the preventive controls or produce safety 
regulations and should not benefit from an exemption from verification 
for their U.S. importers.
    Several comments support the proposed $500,000 annual food sales 
ceiling as a reasonable limit on eligibility for the ``very small'' 
modified FSVP requirements. Other comments maintain that a $1 million 
ceiling would better reflect the types of very small importers and 
foreign suppliers operating today. One comment proposes that FDA set 
the annual sales ceiling at $2 million to be consistent with how 
``small companies'' are defined in Japan.
    Some comments state that other factors, either instead of, or in 
addition to, the monetary value of food sales, should be considered in 
defining very small importers and very small foreign suppliers. Some 
comments maintain that a more appropriate eligibility standard would be 
volume of food handled or sold, reflecting the fact that sales revenues 
vary by type of food, origin, quantity, price, and inflation rates. One 
comment states that a very

[[Page 58588]]

small foreign supplier should be defined as one that has fewer than 100 
employees, contending that use of a monetary value ceiling would 
provide an unfair advantage to foreign firms because many foreign 
suppliers are located in countries with currencies valued lower than 
the U.S. dollar.
    Several comments state that the definitions of very small importer 
and very small foreign supplier should align with the definition of 
very small business under the preventive controls regulations. The 
comments state that such alignment is needed to reduce unnecessary 
confusion, help FDA achieve its stated goal of aligning the FSVP 
provisions with the supplier verification provisions in the preventive 
controls regulations, and ensure that the regulations are consistent 
with U.S. international trade obligations.
2. Revisions Regarding Definitions of Very Small Importer and Very 
Small Foreign Supplier
    We are revising the proposed definitions of very small importer and 
very small foreign supplier by increasing the annual food sales ceiling 
from $500,000 to $1 million, consistent with the revised proposed 
definition of very small business set forth in the Preventive Controls 
supplemental document published elsewhere in this issue of the Federal 
Register. The preamble to the Preventive Controls supplemental document 
states that defining a very small business as a business that has less 
than $1 million in total annual sales of human food adjusted for 
inflation would simplify a food facility's determination of whether it 
is a qualified facility under the preventive controls regulations 
because the facility would only need to calculate its total sales of 
human food rather than determine how much food was sold to qualified 
end users. The preamble to the Preventive Controls supplemental 
document also notes that FDA estimates that businesses with less than 
$1 million in total annual food sales produce less than one percent of 
the dollar value of food that is produced in the United States that 
would be covered by the preventive controls regulations in the absence 
of special provisions for very small businesses. The preamble further 
states that we are not basing the proposed definition of very small 
business on the number of employees or the volume of food sold because 
the statutory criteria for qualified facilities (of which very small 
businesses are a subset) focus on monetary value of sales, rather than 
volume of sales or number of employees.
    To more appropriately reflect the risk to public health posed by 
the volume of food imported by very small importers and importers of 
food from very small foreign suppliers, as well as to align the 
proposed FSVP regulations with the proposed preventive controls 
regulations, we tentatively conclude that the monetary value ceiling in 
the definitions of very small importer and very small foreign supplier 
should be $1 million, adjusted for inflation. Consistency with the 
monetary value ceiling in the proposed definition of very small 
business under the proposed Preventive Controls for Human Food 
regulations, rather than the monetary value ceiling in the so-called 
Tester Amendment criteria for the definition of qualified facility 
(under section 418(l)(1) of the FD&C Act, is appropriate because use of 
the $1 million ceiling (instead of, for example, a ceiling of $250,000) 
means that any facility with sales below the ceiling would meet the 
definition of a qualified facility. We request comment on whether the 
revised proposed monetary value ceiling of $1 million, adjusted for 
inflation, for very small importers and very small foreign suppliers is 
appropriate, as well as on whether it is appropriate that the ceiling 
be the same as that specified in the definition of very small business 
under the preventive controls regulations.
    As previously noted, the produce safety proposed rule includes 
provisions applicable to ``small businesses,'' which are defined as 
having annual produce sales of no more than $500,000; the proposed rule 
also includes provisions for ``very small businesses,'' which are 
defined as having annual produce sales of no more than $250,000. In 
addition, farms with produce sales of no more than $25,000 would not be 
covered under the proposed produce safety regulations. We also note 
that the revised proposed regulations on preventive controls for food 
for animals define ``very small business'' as having annual sales of 
animal food of less than $2,500,000. We request comment on whether and, 
if so, how the FSVP regulations should take into account these 
definitions and provisions applicable to smaller entities under the 
regulations on produce safety and preventive controls for animal food.
    As with all other matters not specifically addressed in this 
supplemental notice of proposed rulemaking, we are still considering 
the comments that we have received concerning other aspects of the 
proposed modified provisions for very small importers and importers of 
food from very small foreign suppliers. These issues include, but are 
not limited to, whether the regulations should include any such 
modified provisions and, if so, what the modified requirements should 
be and whether the food sales to be considered for determination of 
eligibility should be limited to sales in or to the United States, 
rather than all food sales of an importer or foreign supplier. We will 
address comments on these issues and finalize any requirements for very 
small importers and importers of food from very small foreign suppliers 
in the FSVP final rule.

E. Other Related Revisions

    We are making other revisions to the proposed rule to incorporate 
the changes that we are making regarding food and foreign supplier risk 
evaluations and supplier verification activities.
1. FSVP Reassessments
    We are revising the proposed requirement in Sec.  1.508 of the 
previous proposal for importers to reassess the effectiveness of their 
FSVPs to be consistent with our amended proposal requiring importers to 
evaluate food and foreign supplier risks. Section 1.508(a)(2) in the 
revised regulatory text would require an importer to promptly reassess 
the effectiveness of its FSVP for a food when it becomes aware of new 
information about potential risks associated with the food or foreign 
supplier of the food, instead of when the importer becomes aware of 
information about potential food hazards, as under previous Sec.  
1.508(a)(2).
    Similarly, Sec.  1.508(b) in the revised regulatory text would 
require that, in conducting an FSVP reassessment, an importer update 
its risk evaluation for a food and foreign supplier rather than, as 
under previous Sec.  1.508(b), updating only the hazard analysis the 
importer conducted. If the reassessment led to a change in the 
identified risks, the importer would need to determine whether it 
needed to change its verification activities.
2. Records
    We are revising the proposed recordkeeping requirements to reflect 
the previously discussed proposed amendments regarding: (1) Importers 
whose customers are in compliance with the supplier program 
requirements of the preventive controls regulations, (2) importers 
whose customers are controlling a significant hazard in a food, and (3) 
documentation requirements for supplier verification activities. Under 
previous Sec.  1.510(d)(2), importers would have been required to 
maintain for at least 2 years (after the records were created or 
obtained)

[[Page 58589]]

records of certain supplier verification activities, investigations and 
corrective actions, FSVP reassessments, food subject to certain dietary 
supplement CGMP regulations, and food imported from a country with an 
officially recognized or equivalent food safety system (except that 
records of changes to FSVPs in accordance with the corrective actions 
or reassessment provisions would have had to be maintained until at 
least 2 years after their use was discontinued).
    Under Sec.  1.510(d)(2) in the revised regulatory text, importers 
would be required to maintain for at least 2 years (after the records 
were created or obtained) records of, among other things, written 
assurances from their customers that are in compliance with the 
supplier program requirements of the preventive controls regulations 
and documentation of supplier verification activities that importers 
conduct. Also subject to this requirement would be written assurances 
from importers' customers that the customer has established and is 
following procedures that will significantly minimize or prevent a 
hazard. With respect to records concerning the importation of dietary 
supplements, Sec.  1.510(d)(2) in the revised regulatory text makes 
clear that this 2-year requirement would apply to written assurances of 
compliance with the dietary supplement CGMPs obtained from importers' 
customers and documentation of supplier verification activities 
conducted by importers of dietary supplements (discussed in section 
II.E.3).
3. Dietary Supplements
    We are revising the proposed modified FSVP requirements for 
importers of dietary supplements in Sec.  1.511 of the proposed rule to 
reflect previously discussed revisions to the proposed rule. We are 
revising previously proposed Sec.  1.511(a) and (b) to specify that 
importers of dietary supplements and dietary supplement components that 
are subject to certain dietary supplement CGMP regulations in part 111 
(21 CFR part 111) (or whose customers are subject to those regulations) 
would not be required to comply with revised Sec.  1.506(a), concerning 
the requirement to establish and follow written procedures to ensure 
the use of approved suppliers (which replaces the previously proposed 
requirement to maintain a written list of foreign suppliers). This 
change is appropriate because these importers would not be required to 
conduct risk evaluations, which provide the basis for supplier 
approval. However, we request comment on whether some other requirement 
concerning identification of foreign suppliers would be appropriate for 
these importers, such as a requirement, as originally proposed, to 
maintain a list of the foreign suppliers of the dietary supplements and 
dietary supplement components they import.
    We also are revising several of the provisions in previously 
proposed Sec.  1.511(c) regarding importers of dietary supplements that 
will not be further processed. First, we are revising Sec.  1.511(c)(1) 
to specify that although importers of these ``finished'' dietary 
supplements would not be required to analyze the hazards in the dietary 
supplements they import, they would be required to evaluate the other 
food safety risks set forth in Sec.  1.505(a) in the revised regulatory 
text. Second, under Sec.  1.511(c)(2) in the revised regulatory text, 
importers of these dietary supplements would be required to establish 
and follow written procedures to ensure that foods are imported only 
from approved suppliers (except in the limited circumstances when 
unapproved suppliers may be used), rather than having to maintain a 
list of their foreign suppliers. Third, Sec.  1.511(c)(4) in the 
revised regulatory text now specifies that the purpose of supplier 
verification activities with respect to these dietary supplements is to 
provide assurances that the supplier is producing the dietary 
supplement in accordance with processes and procedures that provide the 
same level of public health protection as those required under part 
111. Finally, in Sec.  1.511(c)(5)(i) through (c)(5)(iv) in the revised 
regulatory text, we are proposing requirements for documentation of 
foreign supplier verification activities by these importers that match 
those discussed in section II.C.5.
4. Very Small Importers and Importers of Food From Very Small Foreign 
Suppliers
    We are revising, in Sec.  1.512 in the revised regulatory text, the 
proposed modified FSVP requirements for very small importers and 
importers of food from very small foreign suppliers by deleting the 
proposed requirement to maintain a list of foreign suppliers. 
Consistent with our approach to requirements for very small businesses 
under the potential supplier program provisions in the preventive 
controls proposed rule, we are not proposing to require very small 
importers and importers of food from very small foreign suppliers to 
institute procedures to verify receipt of food from approved foreign 
suppliers.
5. Food From Countries With Officially Recognized or Equivalent Food 
Safety Systems
    We are revising, in Sec.  1.513 in the revised regulatory text, the 
proposed modified FSVP requirements for importers of food from foreign 
suppliers in countries whose food safety system FDA has officially 
recognized as comparable or determined to be equivalent to that of the 
United States by renumbering references to sections of the regulations 
and by deleting the requirement to maintain a list of foreign 
suppliers. We tentatively conclude that, given the nature of the food 
that may be imported in accordance with these modified provisions 
(e.g., that the food is from a foreign supplier in good compliance 
standing with the food safety authority in a country with a comparable 
or equivalent food safety system), it is not necessary to apply a 
requirement to establish a procedure to verify receipt of food from 
approved suppliers to importers of such food.
6. Qualified Individuals
    We are revising previously proposed Sec.  1.503, ``Who must develop 
my FSVP and perform FSVP activities?'', to revise a reference to 
proposed Sec.  1.512, regarding the modified requirements for very 
small importers and importers of food from very small foreign 
suppliers. Previously proposed Sec.  1.503 states that except with 
respect to the requirements in Sec. Sec.  1.506(a), 1.509, 1.510, 
1.511(c)(2), and 1.512(b)(3) and (b)(6), a qualified individual must 
develop their FSVP and perform each of the activities required under 
the subpart. Previously proposed Sec.  1.512(b)(3) stated the proposed 
requirement to maintain a written list of foreign suppliers, a 
requirement that is being deleted by this supplemental document. 
Previously proposed Sec.  1.512(b)(6) referred to records requirements, 
which have been renumbered as Sec.  1.512(b)(5) in the revised 
regulatory text. Therefore, Sec.  1.503 should be modified to refer 
only to Sec.  1.512(b)(5).

III. Preliminary Regulatory Impact Analysis

    As explained in the 2013 FSVP proposed rule, we performed the 
necessary analyses to examine the impacts of the proposed rule under 
Executive Order 12866, Executive Order 13563, the Regulatory 
Flexibility Act (5 U.S.C. 601-612), the Unfunded Mandates Reform Act of 
1995 (Pub. L. 104-4), and the PRA (44 U.S.C. 3501-3520). We provided a 
preliminary regulatory impact analysis (PRIA) of the proposed rule (see 
Ref. 13 of the

[[Page 58590]]

proposed rule) for public input (78 FR 45730 at 45770).
    We performed additional analyses to examine the impacts of the 
revised proposed provisions described in this Federal Register document 
under Executive Order 12866, Executive Order 13563, the Regulatory 
Flexibility Act, the Unfunded Mandates Reform Act of 1995, and the PRA. 
We present our additional analyses, including the total estimated costs 
and benefits of the FSVP proposed rule as revised, in our supplemental 
PRIA for this proposed rule (Ref. 3). We seek comment on our additional 
analyses.

IV. Paperwork Reduction Act of 1995

    This proposed rule contains information collection requirements 
that are subject to review by the OMB under the PRA (44 U.S.C. 3501-
3520). A description of these provisions is given in the Description 
section with an estimate of the annual reporting, recordkeeping, and 
third-party disclosure burden. Included in the estimate is the time for 
reviewing instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing each 
collection of information.
    FDA invites comments on: (1) Whether the proposed collection of 
information is necessary for the proper performance of FDA's functions, 
including whether the information will have practical utility; (2) the 
accuracy of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.
    Title: Foreign Supplier Verification Programs for Importers of Food 
for Humans and Animals.
    Description: FDA is revising its proposed regulations on FSVPs for 
food for humans and animals. The proposed regulations are intended to 
help ensure that food imported into the United States is produced in 
compliance with processes and procedures, including reasonably 
appropriate risk-based preventive controls, that provide the same level 
of public health protection as the processes and procedures required 
for production of food in compliance with section 418 or 419 of the 
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 350g or 
350h), if either is applicable, and in compliance with sections 402 and 
403(w) of the FD&C Act (21 U.S.C. 342 and 343(w)). The revisions to the 
proposed rule include the following: (1) Specifying a revised approach 
to proposed requirements for supplier verification activities (the 
previous proposal contained two alternative approaches); (2) stating 
that importers who are in compliance with the potential supplier 
program provisions of the preventive controls regulations would be 
deemed in compliance with most of the FSVP requirements; (3) deleting 
the proposed requirement that importers conduct a food and foreign 
supplier compliance status review but adding a proposed requirement 
that importers consider, in addition to the hazards in the food they 
import, certain factors related to supplier risks; (4) proposing to 
require importers to follow written procedures for ensuring the use of 
suppliers that they have approved based on their evaluation of supplier 
risks, rather than require importers to maintain a list of suppliers; 
(5) proposing to require importers of food from farms not subject to 
the produce safety regulations to obtain written assurance of 
compliance from their suppliers rather than conduct standard 
verification activities; and (6) revising the definitions of very small 
importer and very small foreign supplier by increasing the annual food 
sales limit from $500,000 to $1 million.
    Description of Respondents: Generally, persons who import food into 
the United States. We estimate that there are approximately 56,800 
persons who meet the definition of importer set forth in the proposed 
rule. However, the proposed rule would exempt from the FSVP 
requirements the importation of certain foods, including certain juice 
and seafood products, food for research or evaluation (exempt but 
subject to a third-party disclosure requirement), food for personal 
consumption, certain alcoholic beverages, food that is transshipped, 
and food that is imported for further processing and future export. The 
proposed rule also would specify that importers who are in compliance 
with any supplier program provisions that the preventive controls final 
regulations may include would be deemed in compliance with most of the 
FSVP requirements.
    Certain exceptions to the standard FSVP requirements would apply to 
importers of food for which the importer or its customer controls the 
hazards and to importers of food from farms not subject to the produce 
safety regulations. In addition, the proposed rule would establish 
modified FSVP requirements for importers of dietary supplements, very 
small importers, importers of food from very small foreign suppliers, 
and importers of food from suppliers in countries whose food safety 
systems FDA has officially recognized as comparable or determined to be 
equivalent to that of the United States.
    The information collection estimate for the FSVP proposed rule has 
decreased due to revisions to the proposed rule requirements. The 
information collection burden was previously estimated to be 3,303,988 
hours; the revised estimate is 2,917,603 hours, a reduction of 386,385 
hours. For more information on the original calculation of the 
information burden estimate, refer to the PRA for the previous proposed 
rule (Docket No. FDA-2011-N-0143).

Information Collection Burden Estimate

Supplemental Notice of Proposed Rulemaking Burden

    FDA estimates the burden for this information collection as 
follows:

A. Reporting Burden

1. Exemption for Food for Research or Evaluation
    Under proposed Sec.  1.501(c), the FSVP regulations would not apply 
to food that is imported for research or evaluation purposes, provided 
that:
     The food is not intended for retail sale and is not sold 
or distributed to the public.
     The food is labeled with the statement ``Food for research 
or evaluation use.''
     When filing entry for the food with U.S. Customs and 
Border Protection (CBP), the customs broker or filer for the food 
provides an electronic declaration that the food will be used for 
research or evaluation purposes and will not be sold or distributed to 
the public.
    As shown in table 1, we estimate that annually there will be 36,360 
persons for whom a declaration that a food will be used for research or 
evaluation purposes will be submitted, and that about 40 declarations 
will be submitted for each such person annually. We further estimate 
that submission of this declaration should take approximately 0.083 
hours, resulting in a total annual burden of 120,715 hours. There is no 
change from the previous estimated burden.
2. Importer Identification at Entry
    Proposed Sec.  1.509(c) would require importers to ensure that, for 
each line entry of food product offered for importation into the United 
States, its name and Dun and Bradstreet Data

[[Page 58591]]

Universal Numbering System (DUNS) number is provided electronically 
when filing entry with CBP. As shown in table 1, we estimate that each 
of the estimated 56,800 importers would need to ensure that this 
information is provided for an average of 157 line entries each year. 
We further estimate that each such submission would require 0.02 hours, 
resulting in a total annual burden of 178,352 hours. There is no change 
from the previous estimated burden.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
               21 CFR Section                    Number of     responses per   Total annual           Average burden per response           Total hours
                                                respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Exemption for food for research 1.501(c)....          36,360              40       1,454,400  0.083 (5 minutes).........................         120,715
DUNS number for filing with CBP 1.509(c),             56,800             157       8,917,600  0.02 (1.2 minutes)........................         178,352
 1.511(c), 1.512(b)(2).
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................         299,067
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

B. Recordkeeping Burden

1. Documentation of Production of Low-Acid Canned Foods in Accordance 
With 21 CFR Part 113

    Proposed Sec.  1.502(b) would require importers of thermally 
processed low-acid canned foods (LACF) packaged in hermetically sealed 
containers to verify and document that, with respect to microbiological 
hazards that are controlled under part 113 (21 CFR part 113), the food 
was produced in accordance with those regulations, and for all matters 
not controlled under part 113, to have an FSVP as specified in Sec.  
1.502(a). As shown in table 2, we estimate that there are 2,443 
importers of LACF importing an estimated 4 LACF products annually. We 
further estimate that it would take each LACF importer 1 hour to 
document that a food was produced in accordance with part 113. This 
results in a total annual burden of 9,772 hours. There is no change 
from the previous estimated burden.
2. Hazard Analysis
    Revised proposed Sec.  1.504(a) would require importers, for each 
food they import or offer for import, to have a written hazard 
analysis. We estimate that 13,389 importers would need to spend an 
average of 10.5 hours each determining and documenting hazard analyses 
for imported foods, resulting in an estimated burden of 140,584.5 hours 
(46,862 hours annualized).
    Revised proposed Sec.  1.504(d) would permit importers to identify 
the hazards that are reasonably likely to occur with a food by 
reviewing and evaluating the hazard analysis conducted by the foreign 
supplier of the food. If the importer selects this approach to hazard 
analysis it must document the determination it makes based on its 
review and evaluation of the foreign supplier's hazard analysis. As 
shown in table 2, we estimate that 13,389 importers would take this 
approach to hazard analysis for about 7 products each, and that 
evaluating the supplier's hazard analysis and documenting each 
evaluation would require about 1 hour on average. This results in a 
total burden of 93,723 hours (30,929 hours annualized).
3. Risk Evaluation
    Revised proposed Sec.  1.505(a)(2) would require importers to 
document their evaluation of food and supplier risks. As shown in table 
2, we estimate that it will take 12 hours for each of an estimated 
13,389 importers to conduct and document their risk evaluation and 
approval of suppliers, resulting in a total burden of 160,668 hours 
(53,556 hours annualized). In addition, revised proposed Sec.  1.505(b) 
requires that the importer reevaluate risk factors associated with 
suppliers when the importer becomes aware of new information. 
Recognizing that some importers may choose to spend more time less 
often, we estimate it would take about 15 minutes per day to maintain 
and follow these procedures by reviewing information regarding hazards 
and suppliers. This results in a burden of 1,221,746 hours annually.
4. Foreign Supplier Verification and Related Activities
    Under revised proposed Sec.  1.506(a), importers must establish and 
follow adequate written procedures to ensure that they import foods 
only from foreign suppliers that they have approved based on the risk 
evaluation they conduct under Sec.  1.505 or, when necessary and 
appropriate, on a temporary basis from unapproved foreign suppliers 
whose foods importers subject to adequate verification activities 
before distributing, and document the use of those procedures. As shown 
in table 2, we estimate that it would take each of 13,389 importers 8 
hours to establish procedures resulting in a burden of 107,112 hours 
(35,749 hours annualized) and 4 hours annually to document the use of 
such procedures resulting in an annual burden of 53,556 hours for a 
grand total of 89,305 hours annually.
    Under revised proposed Sec.  1.506(b), importers must establish and 
follow adequate written procedures for conducting foreign supplier 
verification activities. As shown in table 2, we estimate that it would 
take each of 13,389 importers 2 hours to establish procedures for about 
4 hazards/products per importer resulting in a total annual burden of 
107,112 hours (35,883 hours annualized).
    Revised proposed Sec.  1.506(d) would require importers to 
determine and document which supplier verification activities are 
appropriate in order to provide adequate assurances that the 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 or 419, as applicable, 
and is producing the food in compliance with sections 402 and 403(w) of 
the FD&C Act. Under revised proposed Sec.  1.506(d)(1)(i), an importer 
may conduct (and document) or obtain documentation of a periodic onsite 
audit of the foreign supplier. As shown in table 2, we estimate that 
2,369 such audits would be conducted or documentation obtained for, 
with each audit requiring an average of 14 hours each, resulting in a 
total annual burden of 33,166 hours.
    Under revised proposed Sec.  1.506(d)(1)(ii), an importer may 
conduct (and document) or obtain documentation from a foreign supplier 
of lot-by-lot or periodic sampling and testing of a food for a hazard. 
As shown in table 2, we estimate that 11,396 importers each year would 
determine that this approach to verification is

[[Page 58592]]

appropriate an average of 5 times per year. We further estimate that 
each incidence of sampling and testing and corresponding documentation 
will require 4 hours. This results in a total annual burden of 227,920 
hours.
    Under revised proposed Sec.  1.506(d)(1)(iii), an importer may 
conduct (and document) or obtain documentation of a review of its 
foreign supplier's food safety records to verify control of a hazard. 
As shown in table 2, we estimate that 11,396 importers each year would 
determine that this approach to verification is appropriate an average 
of 5 times per year. We further estimate that documentation of food 
safety record review would require 1.6 hours, resulting in a total 
annual burden of 91,168 hours.
    Under revised proposed Sec.  1.506(d)(1)(iv), an importer may use a 
different verification procedure that it has established as being 
appropriate based on the risk associated with the food and foreign 
supplier; the importer must document such use. We have not identified 
any alternative verification procedure nor included such costs in the 
PRIA; therefore, we do not identify any associated burden here for 
revised proposed Sec.  1.506(d)(1)(iv).
    Revised proposed Sec.  1.506(d)(4) requires that if a foreign 
supplier of a food is a farm that is not subject to the requirements in 
part 112, the importer need only to: (1) Document, at the end of each 
calendar year, that the food from the foreign supplier is not subject 
to the produce safety regulations and (2) obtain written assurance, at 
least every 2 years, that the foreign supplier is producing the food in 
compliance with the FD&C Act. We estimate that these requirements would 
affect 22,333 importers annually and that each importer would need to 
conduct this documentation for 8 such suppliers each year, with 
documentation of each determination requiring, on average, 0.75 hours. 
This would result in a total annual burden of 133,998 hours.
    Revised proposed Sec.  1.506(d)(5) would allow an importer, instead 
of conducting an onsite audit, to rely on the results of an inspection 
of the foreign supplier by FDA or the food safety authority of a 
country whose food safety system FDA has officially recognized as 
comparable or has determined to be equivalent to that of the United 
States, provided that the inspection was conducted within 1 year of the 
date that the onsite audit would have been required to be conducted. We 
do not estimate a PRA burden associated with this option because FDA 
has only officially recognized one country's food safety system to date 
and the Agency inspects only a small percentage of foreign food 
facilities each year.
5. Review of Complaints, Investigations, and Corrective Actions
    Proposed Sec.  1.507(b) would require an importer, if it became 
aware that an article of food that it imported was adulterated or 
misbranded, to promptly investigate the cause or causes of such 
adulteration or misbranding and to document any such investigation. As 
shown in table 2, we estimate that 10,658 importers would need to 
conduct 1 such investigation each year, and that conducting and 
documenting an investigation will require 14 hours. This would result 
in a total annual burden of 149,212 hours. There is no change from the 
previous estimated burden.
    Revised proposed Sec.  1.507(c) would require an importer to take 
corrective actions if it determines that one of its foreign suppliers 
of a food does not produce the food in compliance with the requirements 
of section 418 or 419 of the FD&C Act, if either is applicable, or 
produces food that is adulterated under section 402 or misbranded under 
section 403(w) of the FD&C Act. Such corrective actions will depend on 
the circumstances but could include discontinuing use of the foreign 
supplier until the cause or causes of noncompliance, adulteration, or 
misbranding have been adequately addressed. In the PRIA we postulated 
that most importers probably already take some type of corrective 
actions if they determine that a food they import is not in compliance 
with appropriate regulations and that they probably document those 
corrective actions. Therefore, because we assume that most importers 
already take these types of corrective actions, we did not estimate the 
cost of additional corrective actions in the PRIA nor calculate a 
burden associated with corrective actions in the PRA.
    Revised proposed Sec.  1.507(d) would require an importer, if it 
determines by means other than its verification activities conducted 
under Sec.  1.506 or Sec.  1.511(c) or its FSVP reassessment conducted 
under Sec.  1.508, that one of its foreign suppliers does not produce 
food in compliance with the requirements of section 418 or 419 of the 
FD&C Act, if either is applicable, or produces food that is adulterated 
under section 402 or misbranded under section 403(w) of the FD&C Act, 
to promptly investigate to determine whether the importer's FSVP is 
adequate and, when appropriate, to modify the FSVP. This provision also 
would require importers to document any such investigations and FSVP 
changes. As shown in table 2, we estimate that, on average, 10,658 
importers will need to conduct an investigation once a year to 
determine the adequacy of their FSVP in accordance with proposed Sec.  
1.507(d) and that conducting and documenting the investigation will 
require 5 hours. This would result in a total annual burden of 53,290 
hours. There is no change from the previous estimated burden.
6. FSVP Reassessment
    Revised proposed Sec.  1.508(b) would require an importer to 
document each reassessment of its FSVP that it conducts under Sec.  
1.508 and any resulting changes to the FSVP. Reassessment would be 
required every 3 years or more frequently if an importer becomes aware 
of new information about potential risks associated with a food or 
foreign supplier. We did not estimate a cost for reassessing an 
importer's FSVP under this requirement in the PRIA because we have 
already incorporated the costs of reassessment into the costs for 
maintaining the various elements of the FSVP in other provisions. 
Therefore we do not calculate an associated PRA burden here.
7. Food Subject to Certain Dietary Supplement CGMP Regulations
    Revised proposed Sec.  1.511 sets forth modified FSVP requirements 
for food that is subject to certain dietary supplement CGMP 
regulations. Under revised proposed Sec.  1.511(a), importers who are 
required to establish specifications under Sec.  111.70(b), (d), or (f) 
(21 CFR 111.70(b), (d), or (f)) with respect to a food, and are in 
compliance with the requirements of part 111 applicable to determining 
whether those specifications are met, must comply with the requirements 
in proposed Sec. Sec.  1.509 and 1.510, but are not required to comply 
with the requirements of proposed Sec. Sec.  1.502 through 1.508. These 
importers are included in the estimated reporting burden for proposed 
Sec.  1.509(c).
    Under revised proposed Sec.  1.511(b), if an importer's customer is 
required to establish specifications under Sec.  111.70(b), (d), or (f) 
with respect to a food, the customer is in compliance with the 
requirements of part 111 applicable to determining whether those 
specifications are met, and the importer annually obtains from its 
customer written assurance that the customer is in compliance with 
those requirements, then for that food the importer must comply with 
the requirements in Sec. Sec.  1.509 and 1.510, but is not required

[[Page 58593]]

to comply with the requirements of Sec. Sec.  1.502 through 1.508. As 
shown in table 2, we estimate that 5,574 importers would need to obtain 
written assurance from an average of 6 customers in accordance with 
revised Sec.  1.511(b) and that documentation of each assurance would 
take 2.25 hours, resulting in a total annual burden of 75,249 hours. In 
addition, these importers are included in the estimated annual 
reporting burden for proposed Sec.  1.509(c).
    Under revised proposed Sec.  1.511(c), importers of ``finished'' 
dietary supplements (i.e., packaged and labeled dietary supplements 
that are not subject to further processing) would be subject to 
different FSVP requirements. Revised proposed Sec.  1.511(c)(2) would 
require importers of finished dietary supplements to establish and 
follow written procedures to ensure that food is imported only from 
foreign suppliers that have been approved for use based on the risk 
evaluation conducted under Sec.  1.505. This burden to importers of 
``finished'' dietary supplements is captured in the burden calculated 
for proposed Sec.  1.506(a). Proposed Sec.  1.511(c)(3) would require 
importers of finished dietary supplements to establish and follow 
procedures for conducting foreign supplier verification activities. 
This burden is included in the burden of revised proposed Sec.  
1.506(b).
    Revised proposed Sec.  1.511(c)(5) would require importers of 
finished dietary supplements to determine and document which 
appropriate verification activities should be conducted, and the 
frequency with which they should be conducted. As shown in table 2, we 
estimate that this provision would affect 1,822 importers annually and 
that each importer would need to make and document about 2 
determinations (regarding both the appropriate verification activity 
and its frequency) each year, with making and documenting of each 
determination requiring 2.5 hours. This would result in a total annual 
burden of 9,110 hours. There is no change from the previous estimated 
burden.
    For each ``finished'' dietary supplement imported, the importer 
would need to conduct one or more of the verification activities listed 
in proposed Sec.  1.511(c)(5)(i) through (c)(5)(iv) before using or 
distributing the dietary supplement and periodically thereafter. The 
estimates associated with these activities are included in the burdens 
presented in table 2 for Sec.  1.506(d)(1)(i) through (d)(1)(iv), 
respectively.
    Revised proposed Sec.  1.511(c) also would require importers of 
finished dietary supplements to conduct risk evaluations, conduct 
investigations and corrective actions, reassess the effectiveness of 
their FSVP, and ensure that information identifying them as the 
importer is provided at entry. These importers have been included in 
the estimated recordkeeping and reporting burdens for these activities 
under proposed Sec. Sec.  1.505, 1.507(b), 1.508(b), and 1.509(c), 
respectively. We do not estimate any specific burden associated with 
corrective actions (Sec.  1.507(c)) as previously discussed.
8. Food Imported by Very Small Importers and From Very Small Foreign 
Suppliers
    Revised proposed Sec.  1.512 sets forth modified proposed FSVP 
requirements for very small importers (i.e., importers with annual food 
sales of not more than $1 million) and food from very small foreign 
suppliers (i.e., foreign suppliers with annual food sales of not more 
than $1 million).
    Under proposed Sec.  1.512(b)(1), if a very small importer or an 
importer of food from a very small foreign supplier chooses to comply 
with the requirements in Sec.  1.512, the importer would be required to 
document, at the end of each calendar year, that it meets the 
definition of very small importer in Sec.  1.500 or that the foreign 
supplier meets the definition of very small foreign supplier in Sec.  
1.500, whichever is applicable. As shown in table 2, we estimate that 
56,800 importers would need to document eligibility each year (either 
that they are a very small importer or that they are obtaining food 
from a very small foreign supplier) and that such documentation would 
require 1 hour. While very small importers would only need to document 
this once per year, importers importing from very small suppliers may 
need to do it more than once, so we use an average of 1.79 records per 
importer, resulting in a total annual burden of 101,770 hours.
    Under revised proposed Sec.  1.512(b)(3), each very small importer 
or importer of food from a very small foreign supplier would need to 
obtain written assurance, before importing the food and at least every 
2 years thereafter, that its foreign supplier is producing the food in 
compliance with processes and procedures that provide at least the same 
level of public health protection as that required under section 418 or 
419 of the FD&C Act, if either is applicable, and is producing the food 
in compliance with sections 402 and 403(w) of the FD&C Act. As shown in 
table 2, we estimate that 56,800 importers would need to obtain an 
average of 2 such written assurances each year and that documentation 
of each assurance would require 2.25 hours, resulting in a total annual 
burden of 255,600 hours.
    Revised proposed Sec.  1.512(b)(4) also would require very small 
importers and importers of food from very small foreign suppliers to 
document corrective actions; as previously stated, we do not estimate 
any specific burden associated with corrective actions.
9. Food Imported From a Country With an Officially Recognized or 
Equivalent Food Safety System
    Revised proposed Sec.  1.513 would establish modified FSVP 
requirements for importers of food from foreign suppliers in countries 
whose food safety systems FDA has officially recognized as comparable 
or determined to be equivalent to that of the United States. If such 
importers met certain conditions or requirements, they would not be 
required to comply with the requirements in proposed Sec. Sec.  1.503 
through 1.508, but they would be required to comply with Sec. Sec.  
1.509 and 1.510.
    Proposed Sec.  1.513(b)(1) would require an importer, before 
importing a food from the foreign supplier and annually thereafter, to 
document that the foreign supplier is in, and under the regulatory 
oversight of, a country whose food safety system FDA has officially 
recognized as comparable or determined to be equivalent and that the 
food is within the scope of FDA's official recognition or equivalency 
determination regarding the food safety authority of the country in 
which the foreign supplier is located.
    Proposed Sec.  1.513(b)(2) would require an importer, before 
importing a food from the foreign supplier, to determine and document 
whether the foreign supplier of the food is in good compliance 
standing, as defined in proposed Sec.  1.500, with the food safety 
authority of the country in which the foreign supplier is located. The 
importer would be required to continue to monitor whether the foreign 
supplier is in good compliance standing and promptly review any 
information obtained. If the information indicated that food safety 
hazards associated with the food were not being adequately controlled, 
the importer would be required to take prompt corrective action and to 
document any such action.
    FDA has officially recognized New Zealand as having a food safety 
system that is comparable to that of the United States; we have not yet 
determined any food safety systems to be equivalent. Because we have 
only recently entered into a systems recognition arrangement with New 
Zealand, we have not been

[[Page 58594]]

able to assess the effect of the arrangement on the importation of food 
from that country. Therefore, we have not included estimates for the 
recordkeeping burdens associated with proposed Sec.  1.513. There is no 
change from the previous estimated burden.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                          Average burden                       Total
                                                             Number of       Number of     Total annual         per                        operating and
                     21 CFR section                        recordkeepers    records per       records      recordkeeping    Total hours     maintenance
                                                                           recordkeeper                       (hours)                          costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Controls for LACF 1.502(b)..............................           2,443            4              9,772            1              9,772  ..............
Determine and document hazards 1.504(a).................          13,389            1             13,389            3.5           46,862  ..............
Review hazard analysis 1.504(d).........................          13,389            7             93,723            0.33          30,929  ..............
Risk evaluation 1.505(a) and (b), 1.511(c)(2)...........          13,389            1             13,389            4             53,556  ..............
Reevaluation of risks 1.505(c)..........................          13,389          365          4,886,985            0.25       1,221,746  ..............
Written procedures for use of approved foreign suppliers          13,389            1             13,389            6.67          89,305  ..............
 1.506(a), 1.511(c)(2)..................................
Written procedures for conducting verification                    13,389            4             53,556            0.67          35,883  ..............
 activities 1.506(b), 1.511(c)(3).......................
Conduct/review audits 1.506(d)(1)(i), 1.511(c)(5)(i)....           2,369            1              2,369           14             33,166      $1,480,625
Conduct periodic sampling/testing 1.506(d)(1)(ii),                11,396            5             56,980            4            227,920     $75,954,340
 1.511(c)(5)(ii)........................................
Review records 1.506(d)(1)(iii), 1.511(c)(5)(iii).......          11,396            5             56,890            1.6           91,168  ..............
Written assurances from foreign suppliers 1.506(d)(4)...          22,333            8            178,664            0.75         133,998  ..............
Investigate adulteration or misbranding 1.507(b),                 10,658            1             10,658           14            149,212      $6,661,250
 1.511(c)(1)............................................
Investigate and determine FSVP adequacy 1.507(d),                 10,658            1             10,658            5             53,290  ..............
 1.511(c)(1)............................................
Written assurances for food produced under dietary                 5,574            6             33,444            2.25          75,249  ..............
 supplement CGMPs 1.511(b)..............................
Determine and document verification activities for                 1,822            2              3,644            2.50           9,110  ..............
 importers of dietary supplements 1.511(c)(5)...........
Document very small importer/very small foreign supplier          56,800            1.79         101,770            1            101,770  ..............
 status 1.512(b)(1).....................................
Written assurances associated with very small importer/           56,800            2            113,600            2.25         255,600  ..............
 very small foreign supplier 1.512(b)(3)................
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................  ..............  ..............  ..............  ..............       2,618,536     $84,096,215
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs associated with this collection of information.

    In compliance with the PRA (44 U.S.C. 3407(d)), the Agency has 
submitted the information collection provisions of this proposed rule 
to OMB for review. These requirements will not be effective until FDA 
obtains OMB approval. Interested persons are requested to send comments 
regarding information collection by December 15, 2014 to the Office of 
Information and Regulatory Affairs, OMB. To ensure that comments on 
information collection are received, OMB recommends that written 
comments be faxed to the Office of Information and Regulatory Affairs, 
OMB, Attn: FDA Desk Officer, FAX: 202-395-6974, or emailed to 
oirasubmission@omb.eop.gov. All comments should be identified 
with the title, ``Foreign Supplier Verification Programs for Importers 
of Food for Humans and Animals.''

V. Analysis of Environmental Impact

    We did not prepare an environmental assessment or an environmental 
impact statement for the 2013 FSVP proposed rule because we determined 
under 21 CFR 25.30(j) that this action is of a type that does not 
individually or cumulatively have a significant effect on the human 
environment. Because we have reached the same determination with 
respect to these revisions to the proposed rule included in this 
supplemental notice of proposed rulemaking, neither an environmental 
assessment nor an environmental impact statement is required for this 
document.

VI. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

VII. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES)

[[Page 58595]]

and may be seen by interested persons between 9 a.m. and 4 p.m., Monday 
through Friday. These references are also available electronically at 
http://regulations.gov. We have verified the Web site addresses in this 
section, but we are not responsible for any subsequent changes to Web 
sites after this document publishes in the Federal Register.

1. FDA, Statement from FDA Deputy Commissioner for Foods and 
Veterinary Medicine, Michael Taylor, on Key Provisions of the 
Proposed FSMA Rules Affecting Farmers, December 19, 2013 (http://
www.fda.gov/Food/GuidanceRegulation/FSMA/
ucm379397.htm?source=govdelivery&utmmedium=email&utm
source=govdelivery).
2. FDA, Proposed 21 Code of Federal Regulations, Part 1, Subpart L--
Foreign Supplier Verification Programs for Food Importers 
(indicating revisions proposed in supplemental notice of proposed 
rulemaking), 2014.
3. FDA, ``Supplemental Preliminary Regulatory Impact Analysis,'' 
Docket Nos. FDA-2011-N-0143, Foreign Supplier Verification Programs 
for Importers of Food for Humans and Animals, and FDA-2011-N-0146, 
Accreditation of Third-Party Auditors/Certification Bodies to 
Conduct Food Safety Audits and to Issue Certifications, 2014 (http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm).

List of Subjects in 21 CFR Part 1

    Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling, 
Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, it is 
proposed that 21 CFR part 1, as proposed to be added on July 29, 2013 
(78 FR 45730), be amended as follows:

PART 1--GENERAL ENFORCEMENT REGULATIONS

0
1. The authority citation for 21 CFR part 1 is revised to read as 
follows:

    Authority:  15 U.S.C. 1453, 1454, 1455; 19 U.S.C. 1490, 1491; 21 
U.S.C. 321, 331, 332, 333, 334, 335a, 343, 350c, 350d, 352, 355, 
360b, 362, 371, 374, 381, 382, 384a, 393; 42 U.S.C. 216, 241, 243, 
262, 264.

Subpart L--[Amended]

0
2. In Sec.  1.500, remove the definition for ``Hazard reasonably likely 
to occur,'' add in alphabetical order definitions for ``Environmental 
pathogen,'' ``Facility,'' ``Known or reasonably foreseeable hazard,'' 
``Pathogen,'' ``Qualified auditor,'' and ``Significant hazard,'' and 
revise the definitions for ``Hazard,'' ``Very small foreign supplier,'' 
and ``Very small importer'' to read as follows:


Sec.  1.500  What definitions apply to this subpart?

* * * * *
    Environmental pathogen means a pathogen that is capable of 
surviving and persisting within the manufacturing, processing, packing, 
or holding environment such that food may be contaminated and may 
result in foodborne illness if that food is consumed without treatment 
to significantly minimize or prevent the environmental pathogen. 
Environmental pathogen does not include the spores of pathogenic 
sporeformers.
    Facility means a domestic facility or a foreign facility that is 
required to register under section 415 of the Federal Food, Drug, and 
Cosmetic Act, in accordance with the requirements of subpart H of this 
part.
* * * * *
    Hazard means any biological, chemical (including radiological), or 
physical agent that is reasonably likely to cause illness or injury in 
the absence of its control.
* * * * *
    Known or reasonably foreseeable hazard means a potential 
biological, chemical (including radiological), or physical hazard that 
is known to be, or has the potential to be, associated with a food or 
the facility in which it is manufactured/processed.
* * * * *
    Pathogen means a microorganism of public health significance.
    Qualified auditor means a person who is a qualified individual as 
defined in this section and has technical expertise obtained by a 
combination of training and experience appropriate to perform the 
auditing function. A foreign government employee could be a qualified 
auditor.
* * * * *
    Significant hazard means a known or reasonably foreseeable hazard 
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 and corrective actions, verification, 
and records) as appropriate to the food, the facility, and the control.
* * * * *
    Very small foreign supplier means a foreign supplier, including any 
subsidiary, affiliate, or subsidiaries or affiliates, collectively, of 
any entity of which the foreign supplier is a subsidiary or affiliate, 
whose average annual monetary value of sales of food during the 
previous 3-year period (on a rolling basis) is no more than $1 million, 
adjusted for inflation.
    Very small importer means an importer, including any subsidiary, 
affiliate, or subsidiaries or affiliates, collectively, of any entity 
of which the importer is a subsidiary or affiliate, whose average 
annual monetary value of sales of food during the previous 3-year 
period (on a rolling basis) is no more than $1 million, adjusted for 
inflation.
* * * * *
0
3. In Sec.  1.502, add paragraphs (c) and (d) to read as follows:


Sec.  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 Sec.  117.136 or Sec.  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 Sec.  1.509.
    (d) Importers whose customer is subject to section 418 of the 
Federal Food, Drug, and Cosmetic Act. If your customer is required to 
establish and implement a risk-based supplier program under Sec.  
117.136 or Sec.  507.43 of this chapter for a food you import, and you 
annually obtain from your customer written assurance that it is in 
compliance with that section, then you are deemed to be in compliance 
with the requirements of this subpart, except for the requirements in 
Sec. Sec.  1.509 and 1.510.
0
4. Revise Sec.  1.503 to read as follows:


Sec.  1.503  Who must develop my FSVP and perform FSVP activities?

    Except with respect to the requirements in Sec. Sec.  1.506(a), 
1.509, 1.510, 1.511(c)(2), and 1.512(b)(5), a qualified individual must 
develop your FSVP and perform each of the activities required under 
this subpart.
0
5. Revise Sec.  1.504 to read as follows:


Sec.  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 
food you import to determine whether there are any significant

[[Page 58596]]

hazards. Your hazard analysis must be written.
    (b) Hazard identification. (1) Your analysis of the known or 
reasonably foreseeable hazards in each food must include the following 
types of hazards:
    (i) Biological hazards, including microbiological hazards such as 
parasites, environmental pathogens, and other pathogens;
    (ii) Chemical hazards, including radiological hazards, pesticide 
and drug residues, natural toxins, decomposition, unapproved food or 
color additives, and food allergens; and
    (iii) Physical hazards.
    (2) Your analysis must include hazards that may be present in a 
food for any of the following reasons:
    (i) The hazard occurs naturally;
    (ii) The hazard may be unintentionally introduced;
    (iii) The hazard may be intentionally introduced for purposes of 
economic gain.
    (c) Hazard evaluation. (1) Your hazard analysis must include an 
evaluation of the hazards identified in paragraph (b) of this section 
to assess the probability that the hazard will occur in the absence of 
controls and the severity of the illness or injury if the hazard were 
to occur.
    (2) The hazard evaluation required by paragraph (c)(1) of this 
section must include an evaluation of environmental pathogens whenever 
a ready-to-eat food is exposed to the environment before packaging and 
the packaged food does not receive a treatment that would significantly 
minimize the pathogen.
    (3) Your hazard evaluation must consider the effect of the 
following on the safety of the finished food for the intended consumer:
    (i) The formulation of the food;
    (ii) The condition, function, and design of the foreign supplier's 
establishment and equipment;
    (iii) Raw materials and ingredients;
    (iv) Transportation practices;
    (v) Harvesting, raising, manufacturing, processing, and packing 
procedures;
    (vi) Packaging and labeling activities;
    (vii) Storage and distribution;
    (viii) Intended or reasonably foreseeable use;
    (ix) Sanitation, including employee hygiene; and
    (x) Any other relevant factors.
    (d) Review of the foreign supplier's hazard analysis. If your 
foreign supplier has analyzed the known or reasonably foreseeable 
hazards for the food to determine whether there are any significant 
hazards, you may meet your requirement to determine whether there are 
any significant hazards in a food by reviewing and assessing the 
analysis conducted by the foreign supplier.
    (e) Microbiological hazards in raw agricultural commodities that 
are fruits or vegetables. If you are importing a raw agricultural 
commodity that is a fruit or vegetable, you are not required to 
determine whether there are any significant microbiological hazards in 
such food.
    (f) No significant hazards. If you evaluate the known and 
reasonably foreseeable hazards in a food and determine that there are 
no significant hazards, you are not required to determine what foreign 
supplier verification and related activities you must conduct under 
Sec.  1.505 and you are not required to conduct such activities under 
Sec.  1.506. This paragraph (f) does not apply if the food is a raw 
agricultural commodity that is a fruit or vegetable and that is subject 
to part 112 of this chapter.
    (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 Sec.  1.505 
and you are not required to conduct such activities under Sec.  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.
0
6. Revise Sec.  1.505 to read as follows:


Sec.  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 that you must 
conduct, you must consider the following:
    (i) The hazard analysis that you conduct in accordance with Sec.  
1.504, including the nature of the hazard.
    (ii) The entity that will be applying controls for the hazards 
analyzed under Sec.  1.504, such as the foreign supplier or the foreign 
supplier's raw material or ingredient supplier.
    (iii) The foreign supplier's procedures, processes, and practices 
related to the safety of the food.
    (iv) Applicable FDA food safety regulations and information 
regarding the foreign supplier's compliance with those regulations, 
including whether the foreign supplier is the subject of an FDA warning 
letter or import alert.
    (v) The foreign supplier's food safety performance history, 
including results from testing foods for hazards, audit results 
relating to the safety of the food, and the supplier's record of 
correcting problems.
    (vi) Any other factors as appropriate and necessary, such as 
storage and transportation practices.
    (2) You must document your evaluation of risks.
    (b) Reevaluation of risk factors. You must promptly reevaluate the 
risk factors specified in paragraph (a)(1) of this section associated 
with a food or foreign supplier when you become aware of new 
information about these factors. If you determine that it is 
appropriate to continue to import the food from the foreign supplier, 
you must document the reevaluation and your determination.
0
7. Revise Sec.  1.506 to read as follows:


Sec.  1.506  What foreign supplier verification and related activities 
must I conduct?

    (a) Use of approved foreign suppliers. You must establish and 
follow written procedures to ensure that you import foods only from 
foreign suppliers you have approved based on the risk evaluation you 
conduct under Sec.  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.
    (b) Foreign supplier verification procedures. You must establish 
and follow adequate written procedures for conducting foreign supplier 
verification activities with respect to the foods you import.
    (c) Purpose of supplier verification. Your foreign supplier 
verification activities must provide adequate assurances that the 
foreign supplier produces 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 or 419, if either is 
applicable, and is producing the food in compliance with sections 402 
and 403(w) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350g, 
350h, 342, and 343(w)).
    (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 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

[[Page 58597]]

document which verification 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 Sec.  1.505.
    (i) Onsite audit of the foreign supplier. (A) An onsite audit of a 
supplier must be performed by a qualified auditor.
    (B) If the food is subject to one or more FDA food safety 
regulations, an onsite audit of the foreign supplier must consider such 
regulations and include a review of the supplier's written food safety 
plan for the food, if any, including its implementation.
    (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.
    (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.
    (B) You must retain documentation of each sampling and testing of a 
food, including identification of the food tested (including lot 
number, as appropriate), the number of samples tested, the test(s) 
conducted (including the analytical methods(s) used), the date(s) on 
which the test(s) were conducted, the results of the testing, any 
corrective actions taken in response to detection of hazards, and 
information identifying the laboratory conducting the testing.
    (iii) Review of the foreign supplier's relevant food safety 
records. You must retain documentation of each record review, including 
the date(s) of review, any corrective actions taken in response to 
significant deficiencies identified during the review, and 
documentation that the review was conducted by a qualified individual.
    (iv) Other appropriate activity. You may conduct other supplier 
verification activities that are appropriate based on the risk 
associated with the food and the foreign supplier. You must document 
each performance of such verification activity.
    (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 or 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 Sec.  1.505.
    (3) Based on the risk evaluation you conduct, it might be 
necessary, under paragraph (d)(1) or (2) of this section, to conduct 
more than one supplier verification activity to address an individual 
hazard or risk factor or multiple hazards or risk factors.
    (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 
Sec.  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.
    (5) Substitution of inspection by FDA or an officially recognized 
or equivalent food safety authority. (i) Instead of an onsite audit 
conducted under paragraph (d)(1) or (2) of this section, an importer 
may rely on the results of an inspection of the foreign supplier by FDA 
or the food safety authority of a country whose food safety system FDA 
has officially recognized as comparable or has determined to be 
equivalent to that of the United States, provided that the inspection 
was conducted within 1 year of the date that the onsite audit would 
have been required to be conducted. You must document the inspection 
results on which you rely.
    (ii) For inspections conducted by the food safety authority of a 
country whose food safety system FDA has officially recognized as 
comparable or determined to be equivalent, the food that is the subject 
of the onsite audit must be within the scope of the official 
recognition or equivalence determination, and the foreign supplier must 
be in, and under the regulatory oversight of, such country.
    (6) Review of results of verification activities. You must promptly 
review the results of the verification activities that you conduct or 
obtain documentation of under paragraph (d) of this section. If the 
results show that the risks for the food or foreign supplier identified 
in the determination you made under Sec.  1.505 are not adequately 
controlled, you must take appropriate action in accordance with Sec.  
1.507(c).
    (7) Independence of qualified individuals. A qualified individual 
who conducts any of the verification activities set forth in paragraph 
(d) of this section must not have a financial interest in the foreign 
supplier and payment must not be related to the results of the 
activity. This does not prohibit you or one of your employees from 
conducting the verification activity.
0
8. Amend Sec.  1.508 by revising paragraphs (a)(2) and (b) to read as 
follows:


Sec.  1.508  How must I reassess the effectiveness of my FSVP?

    (a) * * *
    (2) You must promptly reassess the effectiveness of your FSVP for a 
food you import when you become aware of new information about 
potential risks associated with the food or foreign supplier of the 
food.
    (b) Reassessment and implementation of changes. In conducting a 
reassessment of your FSVP as required by paragraph (a) of this section, 
you must update your risk evaluation for the food and foreign supplier 
in accordance with Sec.  1.505. If the risks you previously identified 
change as a result of the reassessment, you must promptly determine 
whether the verification activities you conduct under Sec.  1.506 or 
Sec.  1.511(c) need to be changed to comply with that section, and you 
must promptly implement any such changes. You must document each 
reassessment you conduct and any resulting changes to your FSVP.
0
9. Amend Sec.  1.510 by revising paragraph (d)(2) to read as follows:


Sec.  1.510  How must I maintain records of my FSVP?

* * * * *
    (d) Record retention. * * *
    (2) You must maintain records required under Sec. Sec.  1.502(d) 
and 1.504(g) (customer assurances), Sec.  1.506(d)(1)(i)(C), 
(d)(1)(ii)(B), (d)(1)(iii), and (d)(1)(iv) (certain verification 
activities), Sec.  1.507 (investigations and corrective actions), Sec.  
1.508 (FSVP reassessments), Sec.  1.511(b) (assurances from customers 
subject to certain dietary supplement current good manufacturing 
practice regulations), Sec.  1.511(c)(5)(i)(C), (c)(5)(ii)(B), 
(c)(5)(iii), and (c)(5)(iv) (certain verification activities for 
importers of certain dietary supplements), and Sec.  1.513(b) (food 
imported from a country with an officially recognized or equivalent 
food safety system) for a period of at least 2

[[Page 58598]]

years after the records were created or obtained, except that you must 
maintain records of any changes to your FSVP in accordance with Sec.  
1.507(d) or Sec.  1.508(b) until at least 2 years after their use is 
discontinued.
0
10. Amend Sec.  1.511 by:
0
a. Revising the first sentence of paragraph (a);
0
b. Revising paragraph (b);
0
c. Revising paragraphs (c)(1), (2), and (4);
0
d. Revising the second sentence of paragraph (c)(5) introductory text;
0
e. Revising paragraphs (c)(5)(i) through (iv), (6), (7), and (8); and
0
f. Removing paragraph (c)(9).
    The revisions read as follows:


Sec.  1.511  What FSVP must I have if I am importing a food subject to 
certain dietary supplement current good manufacturing practice 
regulations?

    (a) Importers subject to certain dietary supplement current good 
manufacturing practice regulations. If you are required to establish 
specifications under Sec.  111.70(b), (d), or (f) of this chapter with 
respect to a food you import and you are in compliance with the 
requirements of part 111 of this chapter applicable to determining 
whether the specifications you established are met for such food, then 
for that food you must comply with the requirements in Sec. Sec.  1.509 
and 1.510, but you are not required to comply with the requirements in 
Sec. Sec.  1.502 through 1.508. * * *
    (b) Importers whose customer is subject to certain dietary 
supplement current good manufacturing practice regulations. If your 
customer is required to establish specifications under Sec.  111.70(b), 
(d), or (f) of this chapter with respect to a food you import, your 
customer is in compliance with the requirements of part 111 of this 
chapter applicable to determining whether the specifications it 
established are met for such food, and you annually obtain from your 
customer written assurance that it is in compliance with those 
requirements, then for that food you must comply with the requirements 
in Sec. Sec.  1.509 and 1.510, but you are not required to comply with 
the requirements in Sec. Sec.  1.502 through 1.508.
    (c) Other importers of dietary supplements. (1) General. If the 
food you import is a dietary supplement and neither paragraph (a) or 
(b) of this section is applicable, you must comply with paragraph (c) 
of this section and the requirements in Sec. Sec.  1.503, 1.505(a)(2) 
through (a)(6) and (b), and 1.507 through 1.510, but you are not 
required to comply with the requirements in Sec. Sec.  1.504 and 
1.505(a)(1). This requirement does not limit your obligations with 
respect to part 111 of this chapter or any other laws enforced by FDA.
    (2) Use of approved foreign suppliers. You must establish and 
follow written procedures to ensure that you import foods only from 
foreign suppliers that you have approved based on the risk evaluation 
you conduct under Sec.  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.
* * * * *
    (4) Purpose of supplier verification. Your foreign supplier 
verification activities must provide adequate assurances that your 
supplier is producing the dietary supplement in accordance with 
processes and procedures that provide the same level of public health 
protection as those required under part 111 of this chapter.
    (5) Supplier verification activities. * * * You must determine and 
document which verification activity or activities are appropriate to 
provide adequate assurances in accordance with paragraph (c)(4) of this 
section. * * *
    (i) Periodic onsite auditing. You conduct (and document) or obtain 
documentation of a periodic onsite audit of your foreign supplier.
    (A) An onsite audit of a supplier must be performed by a qualified 
auditor.
    (B) The onsite audit must consider the requirements of part 111 of 
this chapter and must include a review of the foreign supplier's 
written food safety plan, if any, and the supplier's implementation of 
such plan.
    (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.
    (ii) Periodic or lot-by-lot sampling and testing of the food. (A) 
Sampling and testing of the dietary supplement may be conducted by you 
or the foreign supplier.
    (B) You must retain documentation of each sampling and testing of a 
dietary supplement, including identification of the food tested 
(including lot number, as appropriate), the number of samples tested, 
the test(s) conducted (including the analytical method(s) used), the 
date(s) on which the test(s) were conducted, the results of the 
testing, any corrective actions taken in response to detection of 
hazards, and information identifying the laboratory conducting the 
testing.
    (iii) Periodic review of the foreign supplier's food safety 
records. You must retain documentation of each record review, including 
the date(s) of review, any corrective actions taken in response to 
significant deficiencies identified during the review, and 
documentation that the review was conducted by a qualified individual.
    (iv) Other appropriate activity. You may conduct other supplier 
verification activities that are appropriate based on the risks 
associated with the food and the foreign supplier. You must document 
each performance of such verification activity.
    (6) Substitution of inspection by FDA or an officially recognized 
or equivalent food safety authority. Instead of an onsite audit 
conducted under paragraph (c)(5)(i) of this section, an importer may 
rely on the results of an inspection of the foreign supplier conducted 
by FDA or the food safety authority of a country whose food safety 
system FDA has officially recognized as comparable or determined to be 
equivalent to that of the United States, provided that the inspection 
was conducted within 1 year of the date that the onsite audit would 
have been required to be conducted. You must document the inspection 
results on which you rely. For inspections conducted by the food safety 
authority of a country whose food safety system FDA has officially 
recognized as comparable or determined to be equivalent, the food that 
is the subject of the onsite audit must be within the scope of the 
official recognition or equivalence determination, and the foreign 
supplier must be in, and under the regulatory oversight of, such 
country.
    (7) Review of results of verification activities. You must promptly 
review the results of the verification activities that you conduct or 
obtain documentation of under paragraph (c)(5) of this section. If the 
results show that the foreign supplier does not meet the standard in 
paragraph (c)(4) of this section, you must take appropriate action in 
accordance with Sec.  1.507(c).
    (8) Independence of qualified individuals conducting verification 
activities. A qualified individual who conducts any of the verification 
activities set forth in paragraph (c)(5) of this section must not have 
a financial interest in the foreign supplier and payment must not be 
related to the results of the activity. This does not prohibit you or 
one of your employees

[[Page 58599]]

from conducting the verification activity.
0
11. Amend Sec.  1.512 by:
0
a. Revising paragraph (b)(2);
0
b. Removing paragraph (b)(3);
0
c. Redesignating paragraphs (b)(4) and (5) as paragraphs (b)(3) and 
(4), respectively;
0
d. Revising newly redesignated paragraph (b)(4); and
0
e. Removing paragraph (b)(6).
    The revisions read as follows:


Sec.  1.512  What FSVP may I have if I am a very small importer or I am 
importing food from a very small supplier?

* * * * *
    (b) Applicable requirements. * * *
    (2) Additional requirements. If this section applies and you choose 
to comply with the requirements in paragraph (b) of this section, you 
also are required to comply with the requirements in Sec. Sec.  1.502, 
1.503, and 1.509, but you are not required to comply with the 
requirements in Sec. Sec.  1.504 through 1.508 or Sec.  1.510.
* * * * *
    (4) Corrective actions. You must promptly take appropriate 
corrective actions if you determine that a foreign supplier of food you 
import does not produce 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 or 419 of the Federal 
Food, Drug, and Cosmetic Act, if either is applicable, or produces food 
that is adulterated under section 402 or misbranded under section 
403(w) of the Federal Food, Drug, and Cosmetic Act. The appropriate 
corrective actions will depend on the circumstances but could include 
discontinuing use of the foreign supplier until the cause or causes of 
noncompliance, adulteration, or misbranding have been adequately 
addressed. You must document any corrective actions you take in 
accordance with this paragraph (b)(4). This paragraph (b)(4) does not 
limit your obligations with respect to other laws enforced by FDA, such 
as those relating to product recalls.
0
12. Amend Sec.  1.513 by revising paragraph (a) to read as follows:


Sec.  1.513  What FSVP may I have if I am importing a food from a 
country with an officially recognized or equivalent food safety system?

    (a) General. If you meet the conditions and requirements of 
paragraph (b) of this section for a food you are importing, then you 
are not required to comply with the requirements in Sec. Sec.  1.503 
through 1.508. You would still be required to comply with the 
requirements in Sec. Sec.  1.509 and 1.510.
* * * * *

    Dated: September 16, 2014.
Peter Lurie,
Associate Commissioner for Policy and Planning.
[FR Doc. 2014-22448 Filed 9-19-14; 8:45 am]
BILLING CODE 4164-01-P