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

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URL: https://www.frixlaw.com/law-library/documents/fr%3A2013-17993

## Record

- **Collection:** Federal Register
- **Document type:** Proposed Rule
- **Published:** July 29, 2013
- **Citation:** 78 FR 45730

## Text

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.

SUMMARY:

The Food and Drug Administration (FDA) is proposing to adopt regulations on foreign supplier verification programs (FSVPs) for importers of food for humans and animals. The proposed regulations would require importers 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 those required under the hazard analysis and risk-based preventive controls and standards for produce safety sections of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), is not adulterated, and is not misbranded with respect to food allergen labeling. We are proposing these regulations in accordance with the FDA Food Safety Modernization Act (FSMA). The proposed regulations would help ensure that imported food is produced in a manner consistent with U.S. standards.

DATES:

Submit either electronic or written comments on the proposed rule by November 26, 2013.

ADDRESSES:

You may submit comments on this proposed rule, identified by Docket No. FDA-2011-N-0143 and/or Regulatory Information Number (RIN) 0910-AG64, 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:

•
FAX:
301-827-6870.

•
Mail/Hand delivery/Courier (for paper, disk, or CD-ROM 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 Agency name, Docket No. FDA-2011-N-0143, and RIN 0910-AG64 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 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 Proposed Rule

Summary of Major Provisions

Modified Provisions for Certain Types of Importers

Costs and Benefits

I. Background

A. Background and Legal Authority

B. Considerations Regarding Verification of Compliance of Imported Food With U.S. Requirements

C. Principal Features of the Proposed Rule

II. Description of the Proposed Rule

A. Definitions (Proposed § 1.500)

B. Applicability and Exemptions (Proposed § 1.501)

C. Scope of FSVP (Proposed § 1.502)

D. Personnel (Proposed § 1.503)

E. Review of Food and Foreign Supplier Compliance Status (Proposed § 1.504)

F. Hazard Analysis (Proposed § 1.505)

G. Foreign Supplier Verification and Related Activities (Proposed § 1.506)

H. Complaints, Investigations, and Corrective Actions (Proposed § 1.507)

I. Reassessment of FSVP (Proposed § 1.508)

J. Identification of Importer at Entry (Proposed § 1.509)

K. Records (Proposed § 1.510)

L. Dietary Supplements and Dietary Supplement Components (Proposed § 1.511)

M. Very Small Importers and Very Small Foreign Suppliers (Proposed § 1.512)

N. Food From Countries With Officially Recognized or Equivalent Food Safety Systems (Proposed § 1.513)

O. Consequences of Failure To Comply (Proposed § 1.514)

III. Preliminary Regulatory Impact Analysis

A. Overview

B. Regulatory Flexibility Act

C. Small Business Regulatory Enforcement Fairness Act of 1996

D. Unfunded Mandates Reform Act of 1995

E. Paperwork Reduction Act of 1995

F. Public Access to the Analyses

IV. Analysis of Environmental Impact

V. Federalism

VI. Proposed Effective and Compliance Dates

VII. Comments

VIII. References

Executive Summary

Purpose of the Proposed Rule

The proposed rule would adopt regulations on FSVPs that importers must create and follow to help ensure the safety of imported food. The proposed regulations vary based on the type of food product (such as processed foods, produce, and dietary supplements) and category of importer.

Congress required importers to perform risk-based foreign supplier verification activities and directed FDA to promulgate regulations on the content of FSVPs in section 301 of FSMA, codified in section 805 of the FD&C Act. The proposed regulations would require importers to implement FSVPs that provide adequate assurances that the importer's foreign suppliers produce food in compliance with processes and procedures, including risk-based preventive controls, that provide the same level of public health protection as those required under section 418 (concerning hazard analysis and preventive controls) or 419 (concerning produce safety) of the FD&C Act, as appropriate, and in compliance with sections 402 (concerning adulteration) and 403(w) (concerning misbranding regarding allergen labeling) of the FD&C Act.

Summary of Major Provisions

We are proposing a flexible, risk-based approach to foreign supplier verification. The regulations focus on foreseeable food safety risks identified through a hazard assessment process, rather than all risks covered by the adulteration provisions in section 402 of the FD&C Act. Because the principle of

hazard assessment is well accepted and understood throughout the international food safety community (e.g., as a key component of hazard analysis and critical control point (HACCP) and preventive controls programs), we believe that it provides the most effective way to implement a risk-based framework in which importers can evaluate potential products and suppliers and conduct appropriate verification efforts.

The proposed FSVP regulations also align with key components of the preventive controls programs that food manufacturers and processors should follow to ensure food safety, as discussed in FDA's recently issued proposed rule on current good manufacturing practice (CGMP) and hazard analysis and risk-based preventive controls for human food. The general FSVP framework, together with the modified provisions discussed in the next section, are intended to be sufficiently general and flexible to apply to a variety of circumstances without being unduly burdensome or restrictive of trade.

Although the FSVP requirements would apply to most imported food under FDA's regulatory jurisdiction, certain categories of imported food would not be covered under the FSVP regulations, as shown in Diagram 1 below. (The diagrams set forth below are intended to illustrate the FSVP requirements and do not include all aspects of the proposed regulations.) These exemptions include certain juice, fish, and fishery products (which are already subject to verification under FDA's HACCP regulations), food for personal consumption, alcoholic beverages, food that is transshipped, food that is imported for re-export, and food for research or evaluation.

BILLING CODE 4160-01-P

EP29JY13.002

The proposed FSVP regulations would require importers to:

(1) Review the compliance status of foods and potential foreign suppliers. Before importing a food from a foreign supplier, importers would be required to review the compliance status of the food and the foreign supplier, including whether either is the subject of an FDA warning letter, import alert, or certification requirement relating to the safety of the food. These documents are or would be available at FDA's Web site.

(2) Determine the hazards reasonably likely to occur with each food. Importers could conduct their own analysis of the potential hazards with a food or review and evaluate the hazard analysis conducted by the food's foreign supplier.

(3) Conduct supplier verification activities. Importers would need to maintain a written list of foreign suppliers and establish written verification procedures. Importers would need to verify that hazards identified as reasonably likely to occur in a food they import are being adequately controlled. If the importer or its customer is controlling a hazard, the proposed rule would require the importer to document such control. For other hazards, the proposed rule

presents two alternative proposals for requirements regarding verification activities. Under Option 1 of this co-proposal, onsite auditing of the foreign supplier would be required for hazards to be controlled by the foreign supplier when there is a reasonable probability that exposure to the hazard will result in serious adverse health consequences or death. Onsite auditing also would be required under Option 1 for microbiological hazards in certain raw agricultural commodities (RACs) that are fruits or vegetables. Audits could be conducted by auditors that are accredited in accordance with the accreditation system that FDA is developing to implement section 307 of FSMA, but the proposal would not require the use of accredited auditors. Also, instead of an onsite audit, an importer could 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.

For other hazards, including less serious hazards and hazards that the foreign supplier verifies have been controlled by its supplier, importers would have the flexibility under Option 1 to choose the verification activity or activities that will provide sufficient assurance that the hazards are adequately controlled. These activities could include onsite auditing of the foreign supplier, periodic or lot-by-lot sampling and testing, periodic review of the supplier's food safety records, and any other procedure that an importer has established as being appropriate to verify adequate control of a hazard.

Option 2 of the co-proposal would allow importers to choose from among these verification activities for all types of hazards not controlled by the importer or its customer. In determining the appropriate verification activities and how frequently they should be conducted, the importer would need to consider the risk presented by the hazard, the probability that exposure to the hazard will result in serious harm, and the food and foreign supplier's compliance with U.S. food safety regulations.

(4) Review complaints, investigate adulteration or misbranding (with respect to allergen labeling), and take corrective actions in the case of supplier noncompliance.

(5) Reassess the effectiveness of its FSVP when the importer becomes aware of new information about potential hazards associated with a food, or otherwise every 3 years.

(6) Ensure that the importer's name and Dun and Bradstreet Data Universal Numbering System (DUNS) number is provided for each line of entry of food.

(7) Maintain records of their FSVP activities.

These “standard” FSVP requirements are summarized in Diagram 2 (under Options 1 and 2) below:

EP29JY13.003

EP29JY13.004

Modified Provisions for Certain Types of Importers

We are proposing several exceptions to the standard FSVP requirements for certain types of foods and importers. First, as shown in Diagram 3 below, for dietary supplements and dietary supplement components, importers who establish and verify compliance with certain specifications (concerning dietary supplement components, labels, packaging, and labeling) under the dietary supplement CGMP regulations would not be required to comply with most of the standard FSVP requirements, including hazard analysis and standard supplier verification activities. The same would apply to importers whose customer is required to establish such specifications and verify that they are met, except that the importer would have to obtain written assurance that its customer is complying with those requirements. On the other hand, importers of finished dietary supplements would be required to comply with most of the standard FSVP requirements, but they would not have to conduct hazard analyses, and their supplier verification activities would focus on verifying that the supplier is in compliance with the dietary supplement

CGMP regulations, rather than verifying that hazards identified as reasonably likely to occur are being adequately controlled.

EP29JY13.005

Second, as shown in Diagram 4 below, the proposed rule would establish modified FSVP requirements for very small food importers and importers of food from very small foreign suppliers (i.e., entities with annual food sales of no more than $500,000). Because of the relatively small volume of food imported by and from these entities, which should reduce consumers' exposure to, and therefore potential risk from, the imported food, we are proposing that in these situations the importer would not be required to conduct hazard analyses and would be able to verify their foreign suppliers by obtaining written assurance that describes the processes and procedures the suppliers use to ensure the safety of the food.

EP29JY13.006

Third, as shown in Diagram 5 below, the proposed rule would exclude from most of the standard FSVP requirements (including hazard analysis and verification that identified hazards are adequately controlled) food from a foreign supplier in 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 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; and

• The importer determines that the foreign supplier of the food is in good compliance standing with the food safety authority of the country in which the foreign supplier is located.

EP29JY13.007

BILLING CODE 4160-01-C
Costs and Benefits

We summarize the annualized costs (over a 10-year time period discounted at both 3 percent and 7 percent) of the two options for the proposed rule in the table immediately below.

3 percent
7 percent

Co-Proposal Option 1
$472,971,342
$473,380,038

Co-Proposal Option 2
461,407,455
461,821,706

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 compliance with other applicable food safety regulations. The Preliminary Regulatory Impact Analyses for the proposed rules on hazard analysis and 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 proposed rule on FSVPs is an important mechanism for improving and ensuring compliance with the above-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. Background and Legal Authority

In fiscal year 2011, nearly 10.5 million product lines of food (representing unique food products) were imported into the United States (Ref. 1). Human and animal food constitutes nearly 40 percent of all imported product lines regulated by FDA. About 15 percent of all food consumed in the United States is imported, including approximately 50 percent of fresh fruit and 20 percent of fresh vegetables (Ref. 2).

Each year, about 48 million Americans (1 in 6) get sick, 128,000 are hospitalized, and 3,000 die from foodborne diseases, according to estimates from the Centers for Disease Control and Prevention (CDC). Several foodborne disease outbreaks have been traced to imported food, including

outbreaks resulting from consumption of imported fruits, vegetables, and nuts (Ref. 3).

FSMA (Pub. L. 111-353), signed into law by President Obama on January 4, 2011, enables FDA to better protect public health by helping to ensure the safety and security of the U.S. food supply, including both domestic and imported food. FSMA enables us to focus more on preventing food safety problems rather than primarily reacting to problems after they occur. The law also provides us with new enforcement authorities to help us achieve higher rates of compliance for both domestic and imported food with prevention- and risk-based safety standards and to better respond to and contain problems when they do occur.

Section 301 of FSMA adds section 805 to the FD&C Act (21 U.S.C. 384a) 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 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 issue regulations on the content of FSVPs. Section 805(c)(2)(A) states that these regulations shall require that the FSVP of each importer be adequate to provide assurances that each of the importer's foreign suppliers produces food in compliance with processes and procedures, including risk-based preventive controls, that provide the same level of public health protection as those required under sections 418 or 419 of the FD&C Act, as appropriate, and in compliance with sections 402 and 403(w) of the FD&C Act. Section 805(c)(2)(B) states that these regulations shall include such other requirements as FDA deems necessary and appropriate to verify that food imported into the United States is as safe as food produced and sold within the United States.

Section 805(c)(3) of the FD&C Act directs FDA to, as appropriate, take into account differences among importers and types of imported food, including based on the level of risk posed by the imported food. Section 805(c)(4) states that verification activities under FSVPs may include monitoring records for shipments, lot-by-lot certification of compliance, annual onsite inspections, checking the hazard analysis and risk-based preventive control plans of foreign suppliers, and periodically testing and sampling shipments of imported products. Section 805(g) directs FDA to publish and maintain a list of importers participating under this section on the Agency's Web site.

Section 301(b) of FSMA amends section 301 of the FD&C Act (21 U.S.C. 331) by adding section 301(zz), which designates as a prohibited act the importation or offering for importation of a food if the importer (as defined in section 805 of the FD&C Act) does not have in place an FSVP in compliance with section 805. In addition, section 301(c) of FSMA amends section 801(a) of the FD&C Act (21 U.S.C. 381(a)) by stating that an article of food being imported or offered for import into the United States shall be refused admission if it appears from an examination of a sample of such an article or otherwise that the importer is in violation of section 805.

In addition to the authority specified in section 301 of FSMA (adding section 805 of the FD&C Act) to issue these proposed regulations, section 701(a) of the FD&C Act (21 U.S.C. 371(a)) gives us the authority to promulgate regulations for the efficient enforcement of the FD&C Act. Also, some aspects of the proposed FSVP regulations are being issued under section 421(b) of the FD&C Act (21 U.S.C. 350j(b)).

Section 805(b) of the FD&C Act (in section 301(a) of FSMA) directs FDA to issue guidance to assist importers in developing FSVPs. We intend to issue guidance that will provide importers with recommendations on how to comply with the various aspects of the FSVP requirements. We intend to issue a draft FSVP guidance that addresses the final, rather than proposed, regulations. We plan to issue the draft guidance concurrently with the final rule because we believe that this would facilitate more meaningful review and comment on the draft guidance. We anticipate that we will publish the finalized FSVP guidance before importers would be required to come into compliance with the FSVP regulations. We invite comment on our proposed approach to issuance of the draft and final FSVP guidances.

B. Considerations Regarding Verification of Compliance of Imported Food With U.S. Requirements

The proposed FSVP regulations would require importers of most imported food to take risk-based steps to verify that the food they import is produced in compliance with applicable FDA regulatory requirements. The proposed FSVP regulations are intended to work in tandem with other provisions of FSMA and the FD&C Act to create a more seamless system of food safety, applicable to both domestic and imported food, that provides appropriate layers of protection for U.S. consumers. At its core, FSMA establishes a proactive and risk-based approach that assigns to the food industry the primary responsibility for food safety. The use of preventive controls, which is one of the significant elements of this approach, is not new to FDA or the industry. FDA's regulations on the processing of juice and seafood products under HACCP systems, as well as our regulations on thermally processed low-acid foods packaged in hermetically sealed containers (low-acid canned foods or LACF), are examples of preventive controls regulations that we have issued to help ensure that those sectors of the food industry meet their obligation to produce safe food.

FSMA specifies additional explicit responsibilities for the rest of the food industry by emphasizing the use of prevention-oriented standards. In particular, FSMA requires food facilities that manufacture, process, pack, and hold food to implement hazard analysis and risk-based preventive controls (in section 103 of FSMA, codified in section 418 of the FD&C Act), with certain exceptions. FSMA also requires FDA to establish science-based, minimum standards for those that grow, harvest, pack, and hold produce (i.e., RACs that are fruits or vegetables) on a farm (also with certain exceptions) (in section 105 of FSMA, codified in section 419 of the FD&C Act). The intent of these requirements is to ensure that all segments of the food industry meet their responsibility under the FD&C Act to produce safe food.

1. Regulatory Approaches to Domestic and Imported Food

Although FDA applies the same safety standards to domestic and imported food marketed in the United States, we have long taken different regulatory compliance approaches to products produced domestically and abroad.

The logistics associated with conducting foreign inspections in most countries make the kind of unannounced routine inspections of establishments that FDA conducts domestically almost impossible. The same is true of “for cause” inspections when we have evidence of a compliance problem. FDA also has to overcome very

significant hurdles to conduct foreign civil and criminal investigations and prosecutions when violations occur.

These difficulties associated with foreign inspection and enforcement are compounded by the number of foreign firms. There are more foreign firms registered with FDA than domestic firms (even though fewer kinds of foreign firms are required to register).
1

In addition, FDA is able to physically examine only a small fraction of the food that is offered for import into this country. The number of food import lines has grown significantly over the past decade, reaching nearly 10.5 million lines in fiscal year 2011, and we expect this trend to continue in the coming years (Ref. 1; Ref. 2). Finally, foreign firms can be located in places with limited infrastructure where food safety regulatory mandates may lack requirements for risk-based preventive controls or other measures, such as export programs, that provide food safety assurances.

1
Unlike domestic facilities, a foreign facility is not required to register with FDA if the food undergoes further manufacturing/processing (other than de minimis) outside the United States (21 CFR 1.226).

FSMA seeks to create a strong preventive system that places primary responsibility for food safety on industry, but also continues the practice, accepted by the Codex Alimentarius Commission (Codex) (see section I.B.3 of this document), of using a different compliance approach for imported food. For inspections, section 201 of FSMA requires that FDA increase the frequency of inspections at all facilities, but prescribes different rates for domestic and foreign facilities. More specifically, FDA is to inspect domestic high-risk facilities at least every 3 years, after an initial inspection within the first 5 years of FSMA's enactment. For domestic non-high-risk facilities, we must inspect at least every 5 years, after an initial inspection within the first 7 years of enactment. In contrast, FSMA only requires that we conduct at least 600 foreign inspections in the first year after enactment, and then doubles that inspection requirement each year for the next 5 years. In 2016, FDA would be required to do 19,200 foreign inspections.
2

Because there are currently more than 250,000 foreign food facilities registered to export food to the United States (in contrast to approximately 167,000 domestic food facilities) (Ref. 1), even completing 19,200 foreign inspections in 2016 would translate to a statutory inspection rate of less than once every 10 years.

2
The Agency's ability to fully meet the foreign facility inspection requirements is contingent upon having adequate resources.

The preventive controls and produce safety regulations discussed in section I.B.2 of this document, which are cornerstones of FSMA's strong preventive system and place primary responsibility for food safety on industry, will also apply somewhat differently to domestic and foreign producers. Under FSMA, with limited exceptions, preventive controls must be adopted by firms that are required to register with FDA. For U.S. firms, that means that most domestic facilities that manufacture, process, pack, or hold food must implement preventive controls. In contrast, under section 418 of the FD&C Act, far fewer foreign firms will be subject to preventive controls requirements. The only foreign firms that will be subject to those requirements are those facilities that export to the United States without further manufacturing/processing by another facility, except for the addition of labeling or any similar activity of a de minimis nature (section 418; 21 CFR 1.225 and 1.226).

Because of the different challenges to U.S. government oversight of foreign food establishments exporting to the United States, FSMA includes several provisions that focus on imported food, including the requirement that importers establish FSVPs. FSMA also states (in section 404) that the provisions of the act and any amendments to the FD&C Act may not be construed in a way that is inconsistent with the agreement establishing the World Trade Organization (WTO) or any other treaty or international agreement to which the United States is a party. The FSVP provisions in FSMA ensure that U.S. importers, who are domestic entities, share responsibility for food safety with the foreign suppliers of those foods by requiring that importers perform risk-based supplier verification activities. This requirement, in conjunction with FDA oversight of importers, is vital to ensuring a consistent level of protection for domestic and imported foods.

FSMA's FSVP provisions build on existing approaches to importer regulation. Importers of juice and certain seafood products have for more than a decade been required to comply with FDA regulations designed to help ensure that these imported products are processed in accordance with regulations on HACCP systems for juice and seafood products in parts 120 and 123 of FDA's regulations (Title 21 of the Code of Federal Regulations) (21 CFR parts 120 and 123), respectively. The regulations applicable to seafood importers in § 123.12 became effective on December 18, 1997 (see 60 FR 65096, December 18, 1995), and the regulations applicable to juice importers in § 120.14 became effective on January 22, 2002 (see 66 FR 6138, January 19, 2001). The principal components of both the juice and seafood importer requirements are as follows:

• Establish product specifications designed to ensure that each product is not adulterated.

• Implement affirmative steps to ensure that products being offered for entry into the United States were processed under controls that meet the requirements of the relevant HACCP regulations.

• Have evidence that products offered for U.S. entry have been processed under conditions that comply with the applicable HACCP regulations.

2. Proposed Rules on Preventive Controls and Produce Safety

The understanding that the principal responsibility for food safety resides with industry forms the basis of our proposed regulations implementing not only the FSVP provisions but also the preventive controls and produce safety provisions of FSMA. On January 16, 2013, FDA published, in accordance with section 418 of the FD&C Act, a proposed rule on CGMP and hazard analysis and risk-based preventive controls for human food (the “Preventive Controls Proposed Rule”) (78 FR 3646). On the same date that we published the Preventive Controls Proposed Rule, we also published, in accordance with section 419 of the FD&C Act, a proposed rule on standards for the growing, harvesting, packing, and holding of produce for human consumption (the “Produce Safety Proposed Rule”) (78 FR 3503). Although Congress did not specifically direct us to include provisions on supplier verification in the preventive controls regulations (in contrast to its directive to establish FSVP regulations), section 103(a) of FSMA (section 418(o)(3) of the FD&C Act) states that supplier verification activities that relate to the safety of food are included among the appropriate preventive controls procedures, practices, and processes that might be used by food manufacturers and processors. Approval and verification of suppliers of raw materials and ingredients is widely accepted in the domestic and international food safety community, and, as stated in the Preventive Controls Proposed Rule, we believe that such programs are an important part of an effective preventive controls approach.

Therefore, although we did not propose specific regulations on supplier verification in the Preventive Controls Proposed Rule, we requested comment on when and how approval and verification of suppliers of raw materials and ingredients are an appropriate part of preventive controls (78 FR 3646 at 3665 to 3667). We sought comment on several different aspects of supplier approval and verification programs, including whether to require that a facility consider regulatory information about the supplier, whether to specify that the type of verification conducted be linked to the seriousness of the hazard in a food, and whether to specify the frequency with which verification activities should be conducted. In addition, we stated that “FDA intends to align regulations implementing supplier verification under section 418 and regulations implementing FSVP under section 805 to the fullest extent” to avoid imposing duplicative requirements on entities under those regulations (because they are both a registered food facility and a food importer). We also emphasized the importance of ensuring that any supplier verification provisions that are included in the preventive controls and FSVP regulations comport with U.S. international obligations, including those under the WTO's Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) (78 FR 3646 at 3767). Elsewhere in this document, we discuss particular areas where we believe it is important to coordinate the FSVP and preventive controls regulations.

3. Consistency With Relevant International Standards and Agreements

As noted previously, section 404 of FSMA states that the provisions of FSMA are not to be construed in a manner inconsistent with U.S. international obligations. As a WTO Member, the United States must act consistently with all WTO obligations, including those contained in the SPS Agreement (Ref. 4). FSMA was notified to the WTO on February 14, 2011 (G/SPS/N/USA/2156) (Ref. 5), to provide information on the act to WTO Members. The notification included an electronic mailbox link to receive comments from Members. Several comments have been received via the mailbox. The comments note a high degree of interest in FSMA implementation, particularly with respect to how implementation will impact developing countries.

The proposed FSVP regulations recognize the relevance of the work of Codex in establishing international food safety standards, guidelines, and recommendations. Codex was formed in 1963 by the Food and Agriculture Organization and the World Health Organization of the United Nations to develop food standards, guidelines, and related texts such as codes of practice, and is recognized by the WTO as the international standards organization for food safety. In describing the general characteristics of food import control systems, the Guidelines for Food Import Control Systems (CAC/GL 47-2003) (Ref. 6) developed by the Codex Committee on Food Import and Export Inspection and Certification Systems recognize a number of related concepts, including: that countries can set their own appropriate levels of protection (para. 1); that standards should be based on risk and, as far as possible, applied equally to imported and domestic food (paras. 2, 4, 5); that there is a potential need for different approaches to compliance monitoring of domestic and imported food to ensure consistent levels of protection (e.g., para. 15); and that there is utility in conducting audits, along with using other tools, in addition to assessing importer controls to ensure that imported foods are safe, including importers' use of supplier verification systems (e.g., paras. 11, 36).

4. Public Comments on FSVPs

Our development of the proposed FSVP regulations also has been informed by the comments on FSVPs provided at the public meeting on the import safety provisions of FSMA on March 29, 2011, and the public hearing on comparability of food safety systems and import practices of foreign countries on March 30-31, 2011, as well as the comments submitted to the public dockets for these matters (i.e., the docket for this rulemaking, FDA-2011-N-0143, and docket FDA-2011-N-0135).

C. Principal Features of the Proposed Rule

Consistent with section 805 of the FD&C Act, we are proposing a flexible approach to foreign supplier verification that addresses risk-based differences among certain types of food and their importers. We have tentatively concluded that we should focus the regulations on foreseeable food safety risks rather than all risks covered by the various adulteration provisions in section 402 of the FD&C Act. We therefore are proposing that importers develop and implement FSVPs to adequately verify the control of all hazards that are reasonably likely to occur with the food being imported. We believe that this approach, which is well accepted and understood throughout the food industry as a key component of HACCP and preventive controls, also provides the most comprehensive risk-based framework in which importers can evaluate potential products and suppliers and conduct appropriate verification efforts.

We emphasize that by using this approach to determining which hazards importers should focus on, we do not intend to indirectly impose preventive controls requirements on importers or their suppliers when they are not subject to the proposed preventive controls regulations. For example, as discussed in the Produce Safety Proposed Rule, we have already identified the reasonably foreseeable microbiological hazards associated with produce and are proposing requirements designed to ensure that those hazards are adequately controlled. Therefore, the proposed rule would not require importers of RACs that are fruits or vegetables and that are subject to the regulations on produce safety in proposed part 112 (21 CFR part 112) to reanalyze these microbiological hazards. In addition, in part because section 418 of the FD&C Act contains an exemption relating to facilities that manufacture, process, pack, or hold dietary supplements, we are proposing a modified verification approach for such products. We also are proposing modified FSVP requirements for food from very small foreign suppliers (as determined by annual food sales), and many such suppliers would be exempt from preventive controls as “qualified facilities” under section 418. The proposed rule also would establish modified requirements for food imported by very small importers (matching the requirements for food from very small foreign suppliers). Modified requirements also would apply to food from a foreign supplier in, and under the regulatory oversight of, a country whose food safety system FDA has officially recognized as “comparable” to that of the United States (e.g., through a signed systems recognition arrangement or other agreement between FDA and the country establishing official recognition of the foreign food safety system) or determined to be equivalent to that of the United States, provided the importer documents that certain conditions are met.

Another principal feature of the proposed rule is that we are presenting two different alternative proposals regarding the requirements for foreign supplier verification activities. Under Option 1, for the importation of food with hazards that are reasonably likely

to cause serious adverse health consequences or death to humans or animals (SAHCODHA) (e.g., many microbiological hazards), the importer would be required, at a minimum, to conduct or obtain the results of an annual onsite audit to ensure that the foreign supplier is adequately addressing the hazards. In other situations involving less serious hazards (e.g., illegal residues of pesticides or animal drugs), importers would have more flexibility to choose an appropriate supplier verification method. Under Option 2 of the co-proposal, importers would have to select a verification activity from among onsite auditing, sampling and testing, review of the supplier's food safety records, or some other appropriate procedure, taking into account the risk presented by the hazard in the food, the probability that exposure to the hazard will result in serious harm, and the food and supplier's status of compliance with U.S. food safety requirements.

Importers have always had the responsibility to offer for entry into the United States products that are not adulterated (60 FR 65096 at 65153). Section 301(a) of the FD&C Act makes it a prohibited act to introduce an adulterated food into interstate commerce, which means that an importer would commit a prohibited act if it offered for import a food that is adulterated under section 402 of the FD&C Act. While many food importers already conduct activities to verify the safety of the foods they import, establishing and following FSVPs will necessitate changes to the operations of many importers, especially those that have not previously conducted significant verification activities. Although many importers will need to change at least some of their business practices and incur costs to comply with the FSVP requirements, conducting foreign supplier verification activities will help these companies ensure that the products they import meet U.S. requirements and are safe for consumption.

II. Description of the Proposed Rule

We are proposing a new subpart L to part 1 of the FDA regulations (21 CFR part 1), entitled “Foreign Supplier Verification Programs for Food Importers,” to specify the content of FSVPs for importers of food for humans and animals.

A. Definitions (Proposed § 1.500)

Proposed § 1.500 sets forth the meaning of several terms that we propose to use in the FSVP regulations. Some of the definitions are self-explanatory or are being used for consistency with the Preventive Controls Proposed Rule; we discuss the definitions for which additional explanation is appropriate.

1. Audit

As set forth in proposed § 1.506(g) and (h) and discussed in section II.G of this document, the proposed rule would require onsite auditing of foreign suppliers in certain circumstances (under one proposed option) and permit onsite auditing as a mechanism for supplier verification under other circumstances. Proposed § 1.500 would define
audit
as the systematic, independent, and documented examination (through observation, investigation, records review, and, as appropriate, sampling and laboratory analysis) to assess a foreign supplier's food safety processes and procedures.

2. Food

Proposed § 1.500 would define
food
as having the meaning given in section 201(f) of the FD&C Act (21 U.S.C. 321(f)), except that it would not include pesticides as defined in 7 U.S.C. 136(u). As discussed in the preamble to the interim final rule entitled “Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002,” pesticides, including those used in or on food for human or animal use, are comprehensively regulated by the Environmental Protection Agency (69 FR 58974 at 58986, October 10, 2003). For the same reason, we tentatively conclude that pesticides were not intended to be considered “food” for purposes of section 805 of the FD&C Act and the FSVP regulations. We request comment on this exclusion and on whether there should be additional exclusions from the definition of food. Comments seeking additional exclusions should provide specific justifications.

3. Foreign Supplier

Proposed § 1.500 would define
foreign supplier
as the establishment that manufactures/processes the food, raises the animal, or harvests the food that is exported to the United States without further manufacturing/processing by another establishment, except for further manufacturing/processing that consists solely of the addition of labeling or any similar activity of a de minimis nature.

We tentatively conclude that the proposed definition of foreign supplier makes the term generally consistent with the definition of foreign facility under the preventive controls section of the FD&C Act. Section 418(o) defines “facility” as a domestic or foreign facility that is required to register with FDA under section 415 of the FD&C Act (21 U.S.C. 350d). Section 415(b)(3)(A) defines “foreign facility” as a facility that manufactures, processes, packs, or holds food, but only if food from such facility is exported to the United States without further processing or packaging outside the United States. Because (as discussed in section II.B of this document) importers generally must verify that, among other things, their foreign suppliers produce food in compliance with processes and procedures that provide the same level of public health protection as those required under section 418 of the FD&C Act, we believe that it is appropriate to define foreign suppliers in a manner that is generally consistent with the scope of section 418.

However, our proposed definition of foreign supplier does not include firms that only pack or hold food even if they are required to register with FDA under section 415 of the FD&C Act. We tentatively conclude that Congress intended the importer to verify a single foreign supplier for a particular shipment of a food and, when several entities are required to register as foreign facilities with respect to that food, excluding a subsequent (and registered) packer or holder would be consistent with this intent. As stated previously in this document, the proposed rule would state that the addition of labeling or any similar activity of a de minimis nature does not constitute further processing or packaging. This proposed limitation to the definition of foreign supplier is consistent with FDA's regulations on the registration of foreign food facilities in § 1.226(a). Because section 805 of the FD&C Act is not limited to suppliers that are subject to section 418 of the FD&C Act, the proposed definition of foreign supplier is not limited to registered facilities. In addition to establishments that manufacture/process food, the definition also encompasses establishments that raise animals or harvest food (unless the animal or harvested food is further manufactured or processed by another establishment).

4. Hazard and Hazard Reasonably Likely To Occur

Proposed § 1.500 would define
hazard
as any biological, chemical, physical, or radiological agent that is reasonably likely to cause illness or injury in the absence of its control. Proposed § 1.500 would define
hazard reasonably likely to occur
as a hazard 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. These definitions match those that appear in the Preventive Controls Proposed Rule.

5. Importer

The term “importer” is defined in section 801(a)(2) of the FD&C Act as follows: “(A) the United States owner or consignee of the article of food at the time of entry of such article into the United States; or (B) in the case when there is no United States owner or consignee as described in subparagraph (A), the United States agent or representative of a foreign owner or consignee of the article of food at the time of entry of such article into the United States.”

Under proposed § 1.500, the importer of a food would be the U.S. owner of the food if there is one or the consignee if there is not a U.S. owner at the time of entry. Thus,
importer
would be defined as the person in the United States who has purchased an article of food that is being offered for entry into the United States; if the article of food has not been sold at the time of U.S. entry, the importer would be the person in the United States to whom the article has been consigned at the time of entry; if the article of food has not been sold or consigned at the time of U.S. entry, the importer would be the U.S. agent or representative of the foreign owner or consignee at the time of entry.

Under the proposed definition, the importer of an article of food might be, but would not necessarily be, the importer of record of the article, i.e., the individual or firm responsible for making entry and payment of import duties. We agree with the majority of comments we received on how to define “importer,” which stated that the person who caused a food to be imported is the person who should be responsible for verifying that the food was produced in accordance with applicable U.S. safety requirements. This person has a direct financial interest in the food and is most likely to have knowledge and control over the product's supply chain. This person is more likely to be the food's U.S. owner (or consignee) than the importer of record for the food, which might be an express consignment operator with little to no knowledge of the safety regulations applicable to the products for which they obtain clearance from U.S. Customs and Border Protection (CBP).

In cases in which a food has not been sold or consigned to a person in the United States at the time of entry, the foreign owner or consignee would need to have a U.S. agent or representative who would be responsible for meeting the FSVP requirements. To make this clear, proposed § 1.509(a) states (as discussed in section II.J.1 of this document) that before an article of food is imported or offered for import into the United States, the foreign owner or consignee of the article (if there is no U.S. owner or consignee) must designate a U.S. agent or representative as the importer of the food for the purposes of the definition of “importer” in § 1.500. This would ensure that there is an entity in the United States who is responsible for meeting the various FSVP requirements, which would improve importer accountability and Agency oversight and enforcement.

Some importers obtain food from foreign suppliers who are part of the same corporate structure as the importer and who may, along with the importer, be subject to a single integrated, company-wide approach to food safety in which hazards are controlled and verified by a common supply chain management system. We request comment on whether importers should not be required to conduct foreign supplier verification, or should be subject to different FSVP requirements, when importing food from entities under the same corporate ownership and, if so, the specific justifications and conditions under which foreign supplier verification should not be required or should be modified.

6. Qualified Individual

Proposed § 1.500 would define
qualified individual
as a person who has the necessary education, training, and experience to perform the activities needed to meet the requirements of this subpart; this person may be, but is not required to be, an employee of the importer. Depending on the applicable requirements, a qualified individual would need to be capable of performing, for example, food hazard analysis and verification of foreign supplier processes and procedures to ensure that hazards are adequately controlled. Proposed § 1.500 further states that, regarding the performance of verification activities related to preventive controls implemented by the foreign supplier in accordance with section 418 of the FD&C Act, a qualified individual must have successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or be otherwise qualified through job experience to develop and implement a food safety system. We are proposing to define the term qualified individual in a slightly different way in the FSVP regulations than in the Preventive Controls Proposed Rule because not all of the foreign suppliers from which importers obtain their food products will be subject to the preventive controls regulations. Therefore, when an importer obtains food from a foreign supplier that is not subject to section 418 of the FD&C Act, such as a manufacturer of dietary supplements, a qualified individual performing FSVP activities for the importer would need to have appropriate education, training, and experience to conduct those activities, but would not necessarily have to be trained or have experience in the development and implementation of the particular risk-based preventive controls required under section 418. We request comment on whether the definition of qualified individual should include additional requirements regarding education, training, and experience.

As noted, the qualified individual may be, but is not required to be, an employee of the importer. The entity best suited to handling supplier verification may not fall within the definition of “importer” as proposed in this rule. The flexibility in the definition of qualified individual means that another entity may be able to conduct many of the supplier verification activities on the importer's behalf.

Proposed § 1.500 further states that the term qualified individual includes, but is not limited to, a third-party auditor that has been accredited in accordance with section 808 of the FD&C Act. As discussed more fully in section II.G.7.a.i of this document, section 307 of FSMA (codified in section 808 of the FD&C Act (21 U.S.C. 384d)) directs us to establish a system for the recognition of accreditation bodies that can accredit third-party auditors as being qualified to conduct food safety audits of foreign suppliers, as well as to develop model accreditation standards. Elsewhere in this issue of the
Federal Register
(78 FR XXXXX), we are publishing a proposed rule to establish a third-party accreditation system in accordance with section 808. We anticipate that in the future many importers will rely on onsite audits conducted at the request of foreign suppliers by third-party auditors accredited in accordance with section

808 to verify that the importers' foreign suppliers are producing food in accordance with U.S. requirements. We expect that this will reduce the costs of complying with the FSVP regulations for both importers and foreign suppliers by reducing the number of onsite audits that importers conduct themselves. However, even after FDA has implemented section 808 and importers begin using accredited third-party auditors to provide verification of their foreign suppliers in accordance with the FSVP regulations, we believe that it would be acceptable for an importer to rely on an audit conducted by a third-party auditor who is a qualified individual but is not accredited in accordance with section 808. We invite comment on whether, at some future date and/or under particular circumstances, importers should no longer be permitted to rely on third-party auditors who are not accredited in accordance with section 808 to conduct onsite audits or other FSVP activities.

In addition, proposed § 1.500 states that an employee of a foreign government may be a qualified individual. We believe that this provision is appropriate because foreign food safety authorities might conduct certain activities on which an importer might rely in complying with its FSVP requirements. For example, as part of an importer's supplier verification activities, the importer might rely on the results of an onsite audit of a foreign supplier conducted by an employee of the food safety authority in that country. Although a foreign food safety authority could be an accredited third-party auditor under section 808 of the FD&C Act, an importer's use of foreign government employees as qualified individuals would not be limited to such accredited auditors. We request comment on ways in which importers might rely on the actions of foreign government employees in complying with FSVP requirements.

7. Raw Agricultural Commodity

As previously stated, this proposed rule includes provisions on foreign supplier verification with respect to RACs that are fruits or vegetables. Proposed § 1.500 states that
raw agricultural commodity
means “raw agricultural commodity” as defined in section 201(r) of the FD&C Act (21 U.S.C. 321(r)).

8. Very Small Importer and Very Small Foreign Supplier

As stated in section I.C of this document, we propose to apply modified FSVP requirements (set forth in proposed § 1.512, discussed in section II.M of this document) to very small importers of food and to food from very small foreign suppliers. Proposed § 1.500 would define
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. Likewise,
very small foreign supplier
would be defined 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. The limitation of $500,000 in annual food sales is consistent with the sales limitation in the definitions of “qualified facility” in the Preventive Controls Proposed Rule and “small business” in the Produce Safety Proposed Rule. As discussed more fully in section II.M of this document, we believe that it is appropriate to establish certain modified FSVP requirements for very small importers and food from very small foreign suppliers under proposed § 1.512.

We tentatively conclude that it is appropriate to limit the scope of the definition of “very small importer” to those importers that have no more than $500,000 in annual food sales. Because the sales value of food is related to the volume of food being brought into the United States by the importer or shipped to this country by the supplier, use of this dollar-value ceiling would help limit the total volume of food imported under these modified provisions.

Our proposed approach to the definitions of very small importer and very small foreign supplier and the FSVP requirements for these entities is discussed further in section II.M of this document. We believe that our proposed approach to defining very small importers and foreign suppliers is an appropriate as well as workable way to determine which importers and foreign suppliers would be subject to modified FSVP requirements. We request comment on this approach, including whether the limit of $500,000 in annual food sales is appropriate. We also request comment on whether the definitions should apply only to U.S. sales of food by the importer or the foreign supplier, rather than worldwide sales by these entities.

We note that the Preventive Controls Proposed Rule includes three options for a proposed definition of “very small business,” a term that is relevant to three provisions of that proposed rule (78 FR 3646 at 3701). The proposal specifies three options for the limit on total annual food sales under the definition of very small business: $250,000, $500,000, or $1,000,000. We request comment on whether the definitions of very small importer and very small foreign supplier under the FSVP regulations should take into account the definition of very small business under the preventive controls regulations and, if so, what limit on total annual food sales would be appropriate for use in these definitions.

B. Applicability and Exemptions (Proposed § 1.501)

Proposed § 1.501 answers the question, “To what foods do the regulations in this subpart apply?” Proposed § 1.501(a) states that, except as specified otherwise in § 1.501, the regulations in subpart L apply to all food imported into the United States and to the importers of such food. Proposed § 1.501(b) through (e) set forth exemptions and exceptions from subpart L for several types of foods: food from juice and seafood HACCP facilities that are in compliance with the HACCP regulations; food imported for research or evaluation purposes; food for personal consumption; alcoholic beverages; and food that is transshipped or imported for further processing and export.

1. Exemption for Food From Juice and Seafood HACCP Facilities

In accordance with section 805(e)(1) and (e)(2) of the FD&C Act, proposed § 1.501(b) would exempt products from certain juice and seafood facilities from subpart L. Section 805(e) states that the foreign supplier verification requirements “shall not apply to a facility if the owner, operator, or agent in charge of such facility is required to comply with, and is in compliance with,” the HACCP regulations for seafood or juice. Section 805(e) further states that the exemption applies to “a facility” that is required to comply with and is in compliance with the juice or seafood HACCP regulations. This raises the question of whether the word “facility” in this context relates to the foreign supplier or the importer.

The language of section 805(e) of the FD&C Act mirrors the language of the juice and seafood HACCP exemption in section 418 of the FD&C Act, which exempts facilities that are required to comply with and are in compliance

with HACCP for juice or seafood from the hazard analysis and risk-based preventive controls required by that section. Given that many foreign suppliers are facilities subject to section 418, and given the role that importers play under section 805 in verifying foreign supplier compliance with applicable U.S. food safety regulations, we tentatively conclude that it was Congress's intent that section 805(e) apply to food being imported from foreign suppliers that are facilities subject to and in compliance with FDA requirements for juice or seafood HACCP. The importer would still be required to verify a foreign supplier's compliance with the juice or seafood HACCP provisions, but would do so under the regulations that are specific to those foods.

There are at least two other potential readings of section 805(e)'s language. One is that section 805(e) would apply to importers that are facilities subject to and in compliance with the juice or seafood HACCP regulations. This interpretation does not account for the fact that not all importers are facilities (e.g., a commodity broker that does not manufacture/process, pack, or hold food), so it would not exempt such an importer even if the juice or seafood products have been produced in compliance with the applicable HACCP requirements. The other reading is that section 805(e) would apply to importers, whether or not they are facilities, that are subject to the importer verification provisions of the juice or seafood HACCP regulations. However, this interpretation is not consistent with the language of section 805(e), which states that it applies to facilities. Thus, we tentatively conclude that the proposed reading that section 805(e) applies to food being imported from foreign suppliers that are facilities subject to and in compliance with FDA requirements for juice or seafood HACCP effectuates the purpose of the FSVP provisions more clearly than either of these other possible interpretations.

Therefore, proposed § 1.501(b) states that the regulations in subpart L do not apply with respect to juice, fish, and fishery products that are imported from a foreign supplier that is required to comply with, and is in compliance with, the regulations on juice in part 120 or the regulations on fish and fishery products in part 123. Proposed § 1.501(b) further states that importers of juice and seafood products that are subject to the regulations in part 120 or part 123, respectively, must comply with the requirements applicable to importers of those products under § 120.14 or § 123.12, respectively. Among other things, those provisions require importers to implement written procedures for ensuring that imported products were processed in accordance with the HACCP regulations, including the use of “affirmative steps” such as obtaining continuing or lot-specific certificates from an appropriate foreign government inspection authority or competent third party, or regularly inspecting foreign processor facilities. Thus, § 1.501(b) makes clear that, in accordance with section 805(e) of the FD&C Act, importers of juice or seafood HACCP products from foreign suppliers that are facilities required to comply with and in compliance with the juice or seafood HACCP regulations are not subject to the verification requirements in the FSVP regulations.

We recognize that section 805 of the FD&C Act and the implementing regulations we are proposing set forth a more comprehensive approach to verification than the existing juice and seafood HACCP regulations. As noted in section I.B of this document, the juice and seafood importer provisions were adopted more than a decade ago. The U.S. Government Accountability Office (GAO), in its April 2011 report entitled “Seafood Safety: FDA Needs to Improve Oversight of Imported Seafood and Better Leverage Limited Resources” (Ref. 7), noted that the seafood importer regulations allow importers to obtain a copy of the foreign processor's HACCP plan and an attestation that the foreign firm processes its seafood products in compliance with the HACCP regulations without also requiring an onsite audit. The GAO report noted some concerns that the purposes of this provision and the HACCP regulations can be defeated if a foreign processor claims to have a HACCP plan that it is not actually following and the importer does not visit the processor to determine whether the processor is implementing the plan it has provided to the importer. In light of FSMA's increased emphasis on the safety of imported food and importers' role in ensuring food safety, as well as the proposed FSVP regulations discussed in this document, we are considering whether it would be appropriate in the future to initiate a rulemaking to revise the regulations applicable to importers of juice and seafood.

2. Food Imported for Research or Evaluation or for Personal Consumption

Section 805(f) of the FD&C Act states that FDA, by notice published in the
Federal Register
, shall establish an exemption from the requirements of section 805 for articles of food imported in small quantities for research and evaluation purposes or for personal consumption, provided that such foods are not intended for retail sale and are not sold or distributed to the public. We tentatively conclude that it is appropriate to include these section 805 exemptions in the proposed regulations implementing that section to allow interested persons to comment on how we propose to implement these exemptions.

Regarding food for research or evaluation, proposed § 1.501(c) states that the regulations in subpart L do not apply to food that is imported for research or evaluation purposes, provided that:

• Such 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 CBP, the importer of record 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.

The latter two provisions are intended to help ensure that the food is, in fact, not intended for retail sale and is not sold or distributed to the public. We tentatively conclude that they would provide an efficient and effective means of determining whether a food is exempt.

Proposed § 1.501(c) further states that food is considered to be imported for research or evaluation purposes only if it is imported in a small quantity that is consistent with a research, analysis, or quality assurance purpose and the entire quantity is used for this purpose.

Under proposed § 1.501(d), the regulations in subpart L would not apply to food that is imported for personal consumption, provided that such food is not intended for retail sale and is not sold or distributed to the public. Proposed § 1.501(d) further states that food is considered to be imported for personal consumption when it is purchased or otherwise acquired by a person in a small quantity for a non-commercial purpose and is not sold or distributed to the public.

We request comment on the proposed exemptions from the FSVP requirements for food imported for research use or for personal consumption, in particular regarding whether and how to define the amount of food that constitutes a “small quantity.”

3. Exemption for Alcoholic Beverages

Section 116(a) of FSMA (21 U.S.C. 2206(a)) provides that, except as

provided by certain listed sections in FSMA, nothing in FSMA, or the amendments made by FSMA, shall be construed to apply to a facility that (1) under the Federal Alcohol Administration Act (27 U.S.C. 201 et seq.) or chapter 51 of subtitle E of the Internal Revenue Code of 1986 (26 U.S.C. 5001 et seq.) is required to obtain a permit or to register with the Secretary of the Treasury as a condition of doing business in the United States; and (2) under section 415 of the FD&C Act is required to register as a facility because such facility is engaged in manufacturing, processing, packing, or holding one or more alcoholic beverages (with respect to the activities of such facility that relate to the manufacturing, processing, packing, or holding of alcoholic beverages).

Section 116(b) of FSMA provides that section 116(a) shall not apply to a facility engaged in the receipt and distribution of any non-alcohol food, except that section 116(a) shall apply to a facility described in section 116(a) that receives and distributes non-alcohol food, provided such food is received and distributed (1) in a prepackaged form that prevents any direct human contact with such food and (2) in amounts that constitute not more than 5 percent of the overall sales of such facility, as determined by the Secretary of the Treasury.

Section 116(c) of FSMA provides that, except as provided in section 116(a) and (b), section 116 shall not be construed to exempt any food, other than alcoholic beverages, as defined in section 214 of the Federal Alcohol Administration Act (27 U.S.C. 214), from the requirements of FSMA (including amendments made by FSMA).

The Preventive Controls Proposed Rule includes provisions implementing the exemptions provided in section 116 of FSMA to establish by regulation the reach of the exemptions. As discussed in the Preventive Controls Proposed Rule, FDA tentatively concludes the following regarding the reach of the exemptions for the purposes of that rule:

• The phrase “obtain a permit or register” should be interpreted broadly, to include not only facilities that must obtain what is technically named a “permit” or must “register” with Treasury, but also those facilities that must adhere to functionally similar requirements as a condition of doing business in the United States, namely, by submitting a notice or application to Treasury and obtaining Treasury approval of that notice or application.

• The exemption would apply not only to domestic facilities that are required to secure a permit, registration, or approval from Treasury under the relevant statutes, but also to foreign facilities of a type that would require such a permit, registration, or approval if they were domestic facilities.

• Activities related to alcoholic beverages (including the manufacturing, processing, packing, or holding of alcoholic beverages) at facilities within the scope of section 116(a) of FSMA would not be subject to section 418 of the FD&C Act. Activities related to foods other than alcoholic beverages (including the receiving, manufacturing, processing, packing, holding, and distributing of such foods) would be subject to section 418 even if those activities occur at facilities that are otherwise within the scope of section 116(a) (unless they qualify for another exemption or are in prepackaged form and constitute 5 percent or less of the facility's overall sales). (For clarity, we use the term “food other than alcoholic beverages” rather than “non-alcohol food” in the Preventive Controls Proposed Rule and in this document.)

• Section 418 of the FD&C Act does not apply to the manufacturing, processing, packing, or holding of food other than alcoholic beverages to the extent that it is physically inseparable from the manufacturing, processing, packing, or holding of alcoholic beverages.

Section 116 of FSMA is premised in part upon status as a facility required to register under section 415 of the FD&C Act (section 116(a)(2) of FSMA). Under the definition in this proposed rule, an “importer” might be a registered facility but would not necessarily be one. If the alcoholic beverages exemption from the FSVP regulations was based on whether the importer of an alcoholic beverage was a registered facility, two firms might import the same product (e.g., a bottled alcoholic beverage) and one would be eligible for the alcoholic beverage exemption from the FSVP regulations because it is required to register (e.g., it packs or holds the alcoholic beverage), while the other would not be eligible for this exemption because it is not required to register (e.g., it is a commodity broker that does not manufacture, process, pack, or hold food for consumption in the United States, or it is a restaurant or retailer). The latter importer would need to conduct supplier verification under section 805 of the FD&C Act while the former would not. Under this interpretation, an importer would be exempt from the section 805 requirements if the importer is a facility required to register under section 415 of the FD&C Act and the importer and the food in question (i.e., the alcoholic beverage or food other than alcoholic beverages) otherwise meet the requirements for exemption under section 116 of FSMA.

An alternative approach to the alcoholic beverages exemption from the FSVP regulations would focus on the foreign supplier. If an alcoholic beverage is being imported, under our proposal the foreign supplier would, by definition, be a facility that is required to register. Our proposed definition of “foreign supplier” means that the supplier would be engaged in manufacturing/processing the alcoholic beverage and that this beverage would not undergo further manufacturing/processing before being exported to the United States, except for labeling or any similar activity of a de minimis nature (see 21 CFR 1.226 regarding foreign facility registration). Under this interpretation, whether an imported food is exempt from section 805 of the FD&C Act would not depend on who the importer happens to be, but the nature of the product being imported—whether the foreign supplier and the food in question (i.e., the alcoholic beverage or food other than alcoholic beverages) meet the requirements for exemption under section 116 of FSMA. This interpretation is consistent with our approach to the alcoholic beverages exemption in the Preventive Controls Proposed Rule. In considering the two proposals together, if a foreign supplier is exempt from section 418 of the FD&C Act by operation of section 116 of FSMA for a particular food, then the importer would not be required to conduct verification of the supplier for the food under section 805. For these reasons, we tentatively conclude that the second approach better effectuates the intent of section 805 and it is appropriate to exempt certain alcoholic beverages, under the conditions stated in proposed § 1.501(e), from the scope of the FSVP regulations.

Therefore, under proposed § 1.501(e)(1)(i) and (e)(1)(ii), the FSVP regulations would not apply with respect to alcoholic beverages that are imported from a foreign supplier that is a facility that meets the following two conditions:

• Under the Federal Alcohol Administration Act (27 U.S.C. 201 et seq.) or chapter 51 of subtitle E of the Internal Revenue Code of 1986 (26 U.S.C. 5001 et seq.), the facility is a foreign facility of a type that, if it were a domestic facility, would require obtaining a permit from, registering with, or obtaining approval of a notice or application from the Secretary of the Treasury as a condition of doing business in the United States; and

• Under section 415 of the FD&C Act, the facility is required to register as a facility because it is engaged in manufacturing/processing one or more alcoholic beverages.

Proposed § 1.501(e)(2)(i) and (e)(2)(ii) would specify that the FSVP regulations would not apply with respect to food other than alcoholic beverages that is imported from a foreign supplier described in § 1.501(e)(1), provided such food:

• Is in prepackaged form that prevents any direct human contact with such food; and

• Constitutes not more than 5 percent of the overall sales of the facility, as determined by the Secretary of the Treasury.

We request comment on our proposed exemption of alcoholic beverages and food other than alcoholic beverages under the conditions specified in proposed § 1.501(e).

4. Inapplicability to Food for Transshipment and Export

Some food is imported into the United States but is not distributed into the U.S. market. For example, some food is transshipped from a foreign country through the United States to a different country. In addition, food may be imported into the United States, subjected to manufacturing or processing, and exported to another country without being consumed or distributed in U.S. commerce. Section 805 of the FD&C Act applies to “each importer” and “the food imported by the importer or agent of an importer.” This could mean that the FSVP requirements apply to all food that is brought across the U.S. border except where there is a specific exemption, such as the exemption for food imported for personal consumption. However, taking into consideration the context of section 805 of the FD&C Act, under which the importer must take affirmative steps to verify the compliance of the food with U.S. safety requirements, we tentatively conclude that section 805 is not intended to apply to food that is neither consumed nor distributed in the United States. Therefore, under proposed § 1.501(f), the regulations in subpart L would not apply to food that is:

• Transshipped through the United States to another country; or

• Imported for future export and that is neither consumed nor distributed in the United States.

C. Scope of FSVP (Proposed § 1.502)

Proposed § 1.502 answers the question, “What foreign supplier verification program (FSVP) must I have?” This section addresses the scope of FSVPs.

As noted above, section 805(c)(2) of the FD&C Act sets forth the scope of an importer's FSVP, i.e., the program must be adequate to provide assurances that each of the importer's foreign suppliers produces food in compliance with processes and procedures that provide the same level of public health protection as those required under section 418 or 419, as appropriate, and with sections 402 and 403(w). We tentatively conclude that the scope of an appropriate FSVP should be as set forth below.

1. General Standard and Verification Approach

Proposed § 1.502(a) states that, except as specified in proposed § 1.502(b), for each food imported, the importer must develop, maintain, and follow an FSVP that provides adequate assurances 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 those 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). Under this provision, importers would be required to develop procedures for the operation of their FSVPs, such as procedures for the following:

• Review of the compliance status of foods and foreign suppliers

• Analysis of hazards reasonably likely to occur with foods

• Determination and performance of appropriate foreign supplier verification activities for foods

• Review of complaints, investigation of adulteration or misbranding, and taking of corrective actions

• Reassessment of the FSVP

• Ensuring that required information is submitted at entry

• Maintenance of records

We tentatively conclude that by developing, maintaining, and following an FSVP that meets the requirements set forth in this proposed rule, an importer would be able to provide assurances that its foreign suppliers were producing food in a manner consistent with the preventive controls or produce safety regulations (if either were applicable) as well as provide assurances that the food is not adulterated or misbranded regarding allergen labeling.

2. Low-Acid Canned Food

In accordance with section 805(e) of the FD&C Act, proposed § 1.502(b) sets forth a standard for FSVPs regarding the importation of thermally processed low-acid canned foods packaged in hermetically sealed containers (low-acid canned foods) that differs slightly from the standard in proposed § 1.502(a). Section 805(e) states that section 805 does not apply to LACF facilities that are required to comply, and are in compliance, with the FDA standards and regulations on LACF, but only with respect to the microbiological hazards regulated under part 113 (21 CFR part 113). With respect to all other types of hazards for LACF, section 805 would apply. Therefore, under proposed § 1.502(b), with respect to those microbiological hazards that are controlled by part 113, an importer of a low-acid canned food must verify and document that the food was produced in accordance with part 113. An importer of a low-acid canned food would not know if it was importing the food from a foreign supplier whose facility was in compliance with part 113 (and thus eligible for the exemption from section 805 with respect to microbiological hazards) unless it conducted some appropriate form of verification, such as auditing. We tentatively conclude that following the FSVP provisions would be an appropriate verification approach if the importer chose to follow this for all LACF hazards, including microbiological hazards. Proposed § 1.502(b) further states that, with respect to all matters that are not controlled by part 113, an importer of a low-acid canned food must have an FSVP as specified in proposed § 1.502(a).

3. Food Imported by Facilities Subject to the Preventive Controls Requirements

Many domestic food manufacturers, both large and small companies, import food ingredients for use in the food products they manufacture or process. These facilities are (with certain exceptions) subject to section 418, and they will be subject to the preventive controls regulations once those regulations become effective.

As stated in section I.B of this document, the Preventive Controls Proposed Rule seeks comment on when supplier approval and verification programs would be appropriate food safety requirements under the preventive controls regulations, as well as comment on what specific supplier approval and verification requirements are appropriate. As stated in that proposed rule and in section I.B of this document, we recognize the importance of coordinating the final preventive controls and FSVP regulations to avoid duplicative requirements, as well as the importance of ensuring that the food safety measures we adopt are consistent

with U.S. international trade obligations, including those contained in the SPS Agreement.

We request comment on how to address foreign supplier verification by importers who could be subject to both the FSVP and preventive controls regulations to prevent the imposition of any duplicative supplier verification requirements. For example, should the FSVP regulations state that an importer that is also required to establish a supplier approval and verification program under the preventive controls regulations for a food, and is in compliance with those regulations, is deemed to be in compliance with the FSVP regulations that address the same matters?

We intend to publish in the near future a proposed rule on preventive controls for animal food that will be similar to the Preventive Controls Proposed Rule applicable to human food. We expect to issue the final rule on FSVPs concurrently with the final rules on preventive controls for human food and animal food, and we expect to adopt the same approach for animal food as we do for human food regarding importers that are in compliance with any supplier verification provisions in those respective preventive controls regulations. We request comment on this proposed approach.

4. Food for Which Importers' Customers Are Subject to the Preventive Controls Requirements

In some cases, an importer's customer is a domestic food facility that would be subject to any supplier verification requirements that we might ultimately adopt as part of the preventive controls regulations. As with the above-described circumstances involving importers who themselves would be subject to any supplier verification requirements under the preventive controls regulations, we believe that requiring importers to conduct verification activities that their customers would have to conduct would not provide additional assurance of the safety of the imported food. Therefore, we request comment on how to coordinate the FSVP and preventive controls regulations to avoid imposing duplicative requirements on importers whose customers could be subject to any supplier verification requirements that are ultimately included in the preventive controls regulations. For example, would it be appropriate for the FSVP regulations to state that an importer whose customer is required to establish a supplier approval and verification program under the preventive controls regulations for a food is deemed to be in compliance with the FSVP regulations? We also request comment on what assurance, if any, importers should be required to obtain from their customer that the customer is in compliance with any preventive controls supplier verification requirements and the frequency with which they should obtain any such assurance.

D. Personnel (Proposed § 1.503)

Proposed § 1.503 answers the question, “Who must develop my FSVP and perform FSVP activities?” Proposed § 1.503 states that, except with respect to the requirements in proposed §§ 1.506(a) (concerning listing of foreign suppliers), 1.509 (concerning steps that an importer must take to ensure that it is identified as the importer of a food when the food is offered for entry into the United States), 1.510 (concerning record keeping), 1.511(c)(2) (concerning listing of foreign suppliers of finished dietary supplements), and 1.512(b)(3) and (b)(6) (concerning listing of foreign suppliers and record keeping by very small importers and importers of food from very small foreign suppliers), a qualified individual must develop an importer's FSVP and perform each of the activities required under subpart L. These activities include: reviewing a food and supplier's compliance status; conducting hazard analysis and foreign supplier verification; reviewing complaints, conducting investigations, and taking corrective actions; and reassessing the FSVP and making any appropriate changes.

Education and training are important to the effective development and implementation of an FSVP, including activities such as: identifying hazards that are reasonably likely to occur in foods; evaluating controls that are intended to address those hazards; assessing the appropriateness of the use of different verification activities for different types of hazards; and determining whether investigatory and corrective actions are appropriate. In addition, the products produced by the food industry are diverse, and the hazards that are reasonably likely to occur with a particular food and in a particular facility depend on a range of factors.

Proposed § 1.503 is consistent with regulations and guidelines requiring the use of trained individuals to conduct food safety operations. The HACCP guidelines issued by the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) recommend that experts who are knowledgeable in the food process either participate in or verify the completeness of the HACCP plan (Ref. 8). Our HACCP regulations for juice and seafood require that a trained individual be responsible for developing the hazard analysis (juice only), developing the HACCP plan, verifying and modifying the HACCP plan, and performing the record review (§§ 120.13 and 123.10, respectively). These regulations also state that job experience will qualify an individual to perform these functions if the experience has provided knowledge at least equivalent to that provided through a standardized HACCP curriculum recognized as adequate by FDA. The U.S. Department of Agriculture's (USDA's) HACCP regulations for meat and poultry state that only an individual who has completed a training course may conduct certain activities, such as development and modification of the HACCP plan (9 CFR 417.7).

In accordance with the proposed definition of “qualified individual,” proposed § 1.503 would mean that an importer would need to employ or obtain or otherwise rely on the services of a person with the necessary education, training, and experience to perform all FSVP activities except those specifically exempted from § 1.503. When these activities involve the review of food safety plans established in accordance with section 418 of the FD&C Act, the qualified individual would need to have training in the principles of hazard analysis and risk-based preventive controls as set forth in section 418.

E. Review of Food and Foreign Supplier Compliance Status (Proposed § 1.504)

Proposed § 1.504 answers the question, “What review of a food and foreign supplier's compliance status must I conduct?” We tentatively conclude that a prudent and responsible importer should review readily-available information regarding whether the Agency has identified any compliance problems with the food or the foreign supplier. Therefore, proposed § 1.504 would require 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. (As discussed in section II.G.7 of this document, under proposed § 1.506(g), an importer also would be required to consider the food

and supplier's compliance status as assessed under § 1.504 in determining appropriate verification activities.)

FDA warning letters and import alerts are available on the Agency's Web site. Section 801(q) gives FDA the authority to require, as a condition for granting admission into the United States to an article of food, that a certification (or other assurance) that the article complies with applicable requirements of the FD&C Act be provided by either (1) an Agency or a representative of the government of the country from which the article of food originated (as designated by FDA) or (2) a person or entity accredited under section 808 of the FD&C Act to provide such certification or assurance. Other information relevant to the compliance status of a food or foreign supplier, which an importer might obtain from FDA or the foreign supplier, could include FDA Form 483s, Establishment Inspection Reports, recall notices, and documents relating to injunctions or seizures. Proposed § 1.504 also would require 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.

We request comment on what compliance information about a food or foreign supplier an importer should be required to obtain and consider as part of its food/supplier compliance status review. We also request comment on whether this information should include information about a foreign supplier's compliance standing with the food safety authority of the country in which it is located.

F. Hazard Analysis (Proposed § 1.505)

Proposed § 1.505 answers the question, “What hazard analysis must I conduct?” As discussed in section I.C of this document, we believe that identification of the hazards that commonly occur with a food is a widely accepted principle of food safety. Incorporating this principle into the proposed FSVP regulations, we tentatively conclude that it is appropriate for importers to identify the hazards that are reasonably likely to occur with the foods they import so that they can conduct verification activities to provide assurance that these hazards are being controlled. We also believe that identification of hazards that are likely to occur will be an effective, risk-based way of focusing importers' verification efforts on ensuring that the appropriate food safety risks have been addressed.

1. Hazard Analysis

Proposed § 1.505(a) would require each importer, except as permitted under proposed § 1.505(d) (discussed in section II.F.4 of this document) and (e) (discussed in section II.F.5 of this document), 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. Proposed § 1.505(a) further states that the importer must document this determination and use it to determine appropriate verification activities in accordance with proposed § 1.506.

In accordance with Congress's directive to use a risk-based approach to foreign supplier verification, the proposed rule would require that the importer identify only the hazards that are reasonably likely to occur with the foods they import. Careful assessment of known or reasonably foreseeable hazards will ensure that an importer has determined whether they are reasonably likely to occur and, if they are, whether the foreign supplier of the food has the capability to produce the food in a manner that will adequately control such hazards. In turn, the importer's verification activities will focus on ensuring that its foreign supplier has adequately controlled such hazards during the food's production (or, in some cases, that an entity such as the importer, the importer's customer, or the supplier of a raw material to the foreign supplier is controlling the hazard). Because hazard analysis is widely accepted in the industry as a fundamental principle of food safety, we tentatively conclude that it is appropriate to require that importers use this basic approach for FSVPs, unless there are applicable FDA food safety regulations intended to comprehensively address all hazards, or a specific subset of the hazards, relevant to a food (e.g., RACs that are fruits or vegetables). We also are proposing this approach to focus importers' verification efforts on those hazards that are reasonably likely to occur and thus can be addressed through routine verification. We request comment on this proposed approach.

We also tentatively conclude that it is appropriate to require importers to consider the severity of the illness or injury if a hazard determined to be reasonably likely to occur were to in fact occur. As discussed in the Preventive Controls Proposed Rule, the HACCP regulations issued by FDA and the USDA, the NACMCF HACCP guidelines (Ref. 8), and the HACCP annex to the Codex General Principles of Food Hygiene (Codex HACCP Annex) (Ref. 9) all recognize the importance of considering the severity of the effects of a hazard when conducting a hazard analysis for a food.

2. Potential Hazards

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.

These hazards are the kinds of contaminants and materials that can lead to adulteration under section 402 of the FD&C Act. The Preventive Controls Proposed Rule includes a discussion of each of these types of hazards and the circumstances under which each can pose a risk to public health (78 FR 3646 at 3734 to 3735). We tentatively conclude that it is also appropriate for food importers to examine these potential hazards as part of their FSVPs (with exceptions discussed elsewhere in this document).

We also tentatively conclude that it is appropriate to require importers to consider only those hazards that occur naturally or may be unintentionally introduced. Intentional hazards raise different issues and concerns. We plan to address the issue of certain intentionally introduced hazards as part of our rulemaking to implement section 106 of FSMA (codified in section 420 of the FD&C Act (21 U.S.C. 350i)), which directs FDA to issue regulations to protect against the intentional adulteration of food, including the establishment of science-based mitigation strategies to prepare and protect the food supply chain at specific vulnerable points. However, we also recognize that some kinds of intentional adulterants could be viewed as reasonably likely to occur, e.g., in foods for which there is a widely recognized risk of economically motivated adulteration in certain circumstances. An example of this kind of hazard is the addition of melamine to certain food products apparently to enhance perceived quality and/or protein content. We request comment on

whether to include potential hazards that may be intentionally introduced for economic reasons. We also request comment on when an economically motivated adulterant can be considered reasonably likely to occur.

3. Hazard Evaluation

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, listed in proposed § 1.505(c)(1) through (c)(9), 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.

We tentatively conclude that these are factors that a prudent person who imports food would consider when evaluating hazards to determine those that are reasonably likely to occur with a food. Further information regarding such factors is provided in the Preventive Controls Proposed Rule (78 FR 3646 at 3736 to 3738). We expect that importers (or the qualified individuals assisting them) will obtain information on these factors from FDA guidance, scientific and technical experts, published scientific literature, trade publications, and foreign suppliers of these foods.

Proposed § 1.505(c)(1) would require that the hazard evaluation consider the ingredients of the imported food. Examples of problems that might occur with a product's ingredients include the presence of an undeclared allergen and inadequate roasting of nuts used in a food product.

Proposed § 1.505(c)(2) would require that the hazard evaluation consider the condition, function, and design of the establishment and equipment of the foreign supplier. The condition, function, or design of an establishment or its equipment could potentially result in the introduction of hazards into foods. For example, older equipment (e.g., older slicing, rolling, and conveying equipment) may be more difficult to clean (e.g., with close-fitting components or hollow parts) and, therefore, provide more opportunities for pathogens to become established in a niche environment than modern equipment designed to address the problem of pathogen harborage in such environments. Equipment designed so that there is metal-to-metal contact may generate metal fragments. An establishment that manufactures soft, fresh cheese (such as queso fresco, which is a ready-to-eat product) may have cold, moist conditions that are conducive to the development of a niche where the pathogen
Listeria monocytogenes
can become established and contaminate food-contact surfaces and, eventually, foods. An establishment design that has closely spaced equipment would provide more opportunities for cross-contact of allergens (such as powdered milk or soy) from one line to another (e.g., through dust) than a facility that has more spacing between equipment.

Proposed § 1.505(c)(3) would require that the hazard evaluation consider transportation practices. A food may become unsafe as a result of poor transportation practices. For example, for certain types of food, a supplier may need to take into account the method of transporting the food in developing its preventive controls, such as for food that is temperature sensitive or susceptible to cross-contamination.

Proposed § 1.505(c)(4) would require that the hazard evaluation consider harvesting, raising, manufacturing, processing, and packing procedures. Examples of hazards that could arise during harvesting include contamination with aflatoxin or a pesticide, and the introduction of a physical hazard such as glass during mechanical harvesting. Hazards may arise from manufacturing processes such as cooling or holding of certain foods due to the potential for germination of pathogenic spore-forming bacteria such as
Clostridium perfringens
and
Bacillus cereus
(which may be present in food ingredients) as a cooked product is cooled and reaches a temperature that will allow germination of the spores and outgrowth. Hazards also may arise from manufacturing processes such as acidification due to the potential for germination of spores of
C. botulinum,
with subsequent production of botulinum toxin, if the acidification is not done correctly and the packaging environment otherwise supports
C. botulinum
growth and toxin formation. Toxins can be produced by the bacteria
Staphylococcus aureus
or
B. cereus
in a product that has been heated and held at room temperature during the manufacturing process if the product formulation supports growth of the bacteria and
S. aureus
or
B. cereus
is present in the ingredients of the product. Physical hazards may occur from metal fragments generated during the manufacture of food on equipment in which metal (e.g., wires, saw blades, knives) is used to cut products during manufacturing.

Proposed § 1.505(c)(5) would require that the hazard evaluation consider packaging activities and labeling activities. For example, whether a product is packaged in glass bottles or in plastic bottles could affect what hazards are reasonably likely to occur with the product.

Proposed § 1.505(c)(6) would require that the hazard evaluation consider storage and distribution of a food. For example, biological hazards are more likely to be reasonably likely to occur during storage and distribution in foods that require refrigerated storage to maintain safety than in shelf-stable foods, which are designed for control of biological hazards.

Proposed § 1.505(c)(7) would require that the hazard evaluation consider the intended or reasonably foreseeable use of a food. For example, if the product may either be cooked by the consumer or used in a manner that does not involve cooking, e.g., a soup mix used as a component of a dip, hazards such as
Salmonella
would need to be considered to determine if they are reasonably likely to occur.

Proposed § 1.505(c)(8) would require that the hazard evaluation consider sanitation, including employee hygiene. Sanitation practices can impact the likelihood of a hazard being introduced into a food. For example, inadequate worker health and hygiene can present the potential for transfer of pathogens such as
Salmonella,
hepatitis A, and norovirus.

Proposed § 1.505(c)(9) would require that the hazard evaluation consider any other relevant factors that might potentially affect the safety of the food for the intended consumer. For example, an unexpected natural disaster could flood some or all of a facility, creating insanitary conditions and potentially contaminating the facility with harmful micro-organisms or chemical residues. Following a natural disaster, environmental contaminants that could enter a facility could be hazards that are reasonably likely to occur.

Although proper evaluation of potential hazards under proposed § 1.505(c) requires the consideration of factors that may occur at various points throughout a food's production and distribution chain, an importer's responsibility to conduct verification activities in accordance with proposed

§ 1.506 applies only to the ability of its foreign supplier (as defined in proposed § 1.500) to control (or verify control of) these hazards (unless they are controlled by the importer or the importer's customer). This means that an importer's verification activities would need to provide assurances regarding the actions of its foreign supplier, but the importer would not be required to conduct verification with respect to any other entities either before or after the foreign supplier in the food's production and distribution chain.

4. Review by Qualified Individual of Foreign Supplier's Hazard Analysis

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). We tentatively conclude that this approach to hazard analysis would reduce the burden on an importer while still ensuring that the importer has an adequate understanding of the hazards that are reasonably likely to occur with a particular food.

5. Microbiological Hazards in RACs That Are Fruits or Vegetables

As stated in section I.C of this document, the proposed produce safety regulations would not require produce farms to determine the microbiological hazards that are associated with each fruit or vegetable they grow. Instead, FDA has identified the reasonably foreseeable microbiological hazards associated with fruits and vegetables and has proposed requirements for measures intended to prevent the introduction of these hazards into this food and to provide reasonable assurances that the produce is not adulterated due to these hazards. For this reason, we tentatively conclude that it would not be appropriate to require importers of RACs that are fruits or vegetables to determine whether there are any microbiological hazards that are reasonably likely to occur with this food. Therefore, proposed § 1.505(e) states that for a RAC that is a fruit or vegetable, an importer is not required to conduct a hazard analysis regarding the microbiological hazards that might be reasonably likely to occur with this food. Instead, the importer will need to verify that this kind of food is produced in compliance with FDA's produce safety standards or equivalent standards.

However, importers of RACs that are fruits or vegetables would still be required to conduct a hazard analysis regarding all non-microbiological hazards that might be associated with the food (i.e., chemical, physical, and radiological hazards). In the case of these kinds of hazards, we anticipate that hazard analysis will not be complicated; it should consist of being aware of how the crop is produced and whether there have been non-microbiological problems associated with the crop or the producer in the past. For example, if an importer is purchasing cucumbers from a country, region, or grower with a history of pesticide residue violations for that food, we would expect the importer to address this potential adulteration. Conversely, if the cucumbers come from a country or region with no history of pesticide residue violations, we would not expect an importer to identify unsafe pesticide residues as a hazard that is reasonably likely to occur, unless new information came to light or questions about the use of pesticides or control of pesticide residues indicated an issue. We anticipate that, in addition to requesting information from foreign suppliers, importers would use public information, such as that available on FDA's Web site from FDA guidance, import alerts, warning letters, and untitled letters, to decide if a hazard was reasonably likely to occur. As we have explained, this assessment is intended to allow importers to focus on those hazards that are likely and thus can be addressed through routine verification.

G. Foreign Supplier Verification and Related Activities (Proposed § 1.506)

Proposed § 1.506 answers the question, “What foreign supplier verification and related activities must I conduct?” Requiring importers to conduct foreign supplier verification activities is the core component of the import safety responsibilities assigned to importers under section 301 of FSMA. Verification of foreign suppliers also is consistent with the principles of verification of suppliers of raw materials and ingredients discussed in the Preventive Controls Proposed Rule (78 FR 3646 at 3765 to 3767), as well as consistent with the intent of the requirements applicable to importers of juice and seafood products under parts 120 and 123.

1. List of Foreign Suppliers

To help ensure that importers are obtaining food only from appropriate foreign suppliers, 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. The list also would assist us in monitoring importers' compliance with the FSVP requirements. We request comment on how the foreign suppliers should be identified in this list to ensure that the information is accurate and not ambiguous to the importer or FDA (e.g., identified by the foreign supplier's name and address, by their name and DUNS number, or by some other means). We would have access to this information upon request under proposed § 1.510(b). Nonetheless, we also request comment on whether the identity of the foreign supplier of the food should also be provided when the food is offered for import, along with the importer information that must be provided under proposed § 1.509(c), and, if so, how the foreign supplier should be identified to ensure that the information is accurate and not ambiguous. Under the prior notice requirements, for each line entry of imported food, we receive the identity of the foreign manufacturer/processor and, if known, the grower (see 21 CFR 1.281). Therefore, any such comments should address how the identity of the foreign supplier could be used in conjunction with the prior notice and other relevant information we currently receive about foreign suppliers.

2. Foreign Supplier Verification Procedures

Proposed § 1.506(b) would require that importers establish and follow adequate written procedures for conducting foreign supplier verification activities with respect to the foods they import. These procedures will state how the importer will comply with § 1.506, including documenting when the importer itself controls hazards under § 1.506(e), documenting customer control of hazards under § 1.506(f), and conducting appropriate foreign supplier verification activities in accordance with § 1.506(g) and (h). We tentatively conclude that establishing and following written procedures on how these activities will be conducted will help ensure that importers properly and consistently verify that the hazards associated with the foods they import are adequately controlled, and will allow us to more effectively monitor

compliance with section 805 of the FD&C Act.

3. Purpose of Supplier Verification

As stated in section II.F.1 of this document, the proposed rule would require importers (with some exceptions) to conduct hazard analyses as part of their FSVPs. To provide assurances of adequate control of hazards reasonably likely to occur, proposed § 1.506(c) would require the importer to conduct activities to verify that such hazards are adequately controlled. The approach of identifying hazards that are reasonably likely to occur and verifying that they are being adequately controlled is sufficiently general and flexible to apply to a variety of circumstances. We tentatively conclude, however, that it would not be appropriate to apply the supplier verification requirement in proposed § 1.506(c)—i.e., that verification activities provide adequate assurances that the hazards identified by the importer have been adequately controlled—to microbiological hazards in RACs that are fruits or vegetables and that would be subject to the produce safety regulations in proposed part 112. This is because, under proposed § 1.505(e), importers of these fruits or vegetables would not be required to conduct a hazard analysis regarding the microbiological hazards for this food. Instead, as discussed below in section II.G.8 of this document, verification for these hazards should address whether foreign suppliers are producing these fruits and vegetables in accordance with the produce safety regulations. Consequently, proposed § 1.506(c) states that supplier verification activities must provide assurances that hazards identified as reasonably likely to occur are adequately controlled “[e]xcept with respect to verification activities specified in [proposed § 1.506(h)] regarding raw agricultural commodities that are fruits or vegetables that are subject to [part 112].” This exception regarding the purpose of supplier assurances would apply only to microbiological hazards for RACs that are fruits or vegetables and that are subject to the proposed produce safety regulations; such RACs that are not subject to those regulations (e.g., fruits and vegetables that are rarely consumed raw or that receive commercial processing that adequately reduces the presence of microorganisms of public health significance) are regarded as having no microbiological hazards with respect to which supplier verification would be warranted.

4. No Hazards Identified

With some foods, an importer might conduct a hazard analysis and conclude that there are no hazards that are reasonably likely to occur. Examples of foods with respect to which it is possible that, depending on the circumstances, no hazards would be reasonably likely to occur are salt and food-grade chemicals such as citric acid. In the forthcoming draft guidance on FSVPs, we intend to provide other examples of foods for which it is possible that no hazard would be reasonably likely to occur. We tentatively conclude that when an importer has determined that no hazards are reasonably likely to occur with a particular food, there would be no public health reason to require the importer to conduct most of the activities under § 1.506. Therefore, proposed § 1.506(d) states that if an importer conducts a hazard analysis in accordance with § 1.505 and determines that there are no hazards that are reasonably likely to occur with a food, the only requirement in § 1.506 with which the importer must comply with respect to that food is to maintain a list of its suppliers of this food in accordance with § 1.506(a). However, if an importer determined that there were no hazards in a food, the importer would need to reassess this determination at least every 3 years in accordance with proposed § 1.508.

Proposed § 1.506(d) also states that this provision regarding an absence of hazards would not apply if the food is a RAC that is a fruit or vegetable and that would be subject to the produce safety regulations. This exception is appropriate because for such food the importer is not conducting a hazard analysis to identify the microbiological hazards that are reasonably likely to occur in the food. The importer would still need to conduct verification activities with respect to microbiological hazards in accordance with proposed § 1.506(h), discussed in section II.G.8 of this document.

5. Hazards Controlled by the Importer

Certain hazards associated with an imported food might be controlled through actions that the importer takes after the food is brought into the United States. Proposed § 1.506(e) states that for a hazard that the importer has identified as reasonably likely to occur with a food that the importer itself will control, the importer must document, at least annually, that it has established and is following procedures that adequately control the hazard. If the importer of a food has established validated preventive controls to ensure that a hazard is adequately controlled, there would be no need for the importer to conduct a foreign supplier verification activity with respect to that hazard. For example, a domestic food facility might import raw peanuts for use as an ingredient in its products. If this importer identifies
Salmonella
as a hazard reasonably likely to occur in the peanuts, the importer would not need to conduct a verification activity with respect to the
Salmonella
hazard in the peanuts if the importer itself treats the peanuts using a process validated to adequately reduce
Salmonella.
Because, in the context of hazards controlled by an importer, process controls such as these generally are designed for the control of microbiological hazards, proposed § 1.506(e) likely would not apply to chemical hazards (such as pesticides, mycotoxins, and drug residues) or radiological hazards (such as iodine-131), although this would not necessarily always be the case.

We request comment on this proposal to require importers that control the hazards in food they import to document their control of these hazards, including on the frequency with which importers should be required to document this control.

As discussed in section II.C of this document, we are requesting 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 food facilities that are required to register. We tentatively conclude that, if a provision to this effect were included in the FSVP regulations in accordance with the inclusion of any supplier verification provisions in the preventive controls regulations, proposed § 1.506(e) would be unnecessary, as importers that control hazards in foods they import would be subject t

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2013-17993. Public record. Not legal advice.