# Amendments to Registration of Food Facilities

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URL: https://www.frixlaw.com/law-library/documents/fr%3A2015-08018

## Record

- **Collection:** Federal Register
- **Document type:** Proposed Rule
- **Published:** April 9, 2015
- **Citation:** 80 FR 19160

## Text

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1
[Docket No. FDA-2002-N-0323]
Amendments to Registration of Food Facilities

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of proposed rulemaking.

SUMMARY:

The Food and Drug Administration (FDA or we) is proposing to amend its regulation for registration of food facilities that requires domestic and foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States to register with FDA. This proposed rule would amend and update FDA's registration regulations and is part of our implementation of the FDA Food Safety Modernization Act (FSMA), which added new provisions for the registration of food facilities. Moreover, a number of provisions in FSMA apply only to facilities required to register, including hazard analysis and risk-based preventive controls and mandatory recall authority. The proposed amendments will further enhance FDA's capabilities with respect to responding to food safety issues, and in addition, provide FDA with information that we can use to focus and better utilize our limited inspection resources.

DATES:

Submit either electronic or written comments on the proposed rule by June 8, 2015. Submit comments on the information collection issues under the Paperwork Reduction Act of 1995 by May 11, 2015, (see the “Paperwork Reduction Act of 1995” section of this document).

ADDRESSES:

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

Electronic Submissions

Submit electronic comments in the following way:

• Federal eRulemaking Portal:
http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

Submit written submissions in the following ways:

• Mail/Hand delivery/Courier (for paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

Instructions:
All submissions received must include the Docket No. FDA-2002-N-0323 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:

With regard to the proposed rule:
Monica Storozyszyn, Center for Food Safety and Applied Nutrition (HFS-615), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-1367.
With regard to the information collection:
FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002,
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

Executive Summary

Purpose of the Proposed Rule

This proposed regulation would implement certain provisions in section 415 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 350d), as amended by section 102 of the FDA Food Safety Modernization Act (FSMA), that relate to registration of food facilities. In addition, this proposed regulation would amend and update FDA's registration regulations to further enhance FDA's capabilities with respect to responding to food-related emergencies, and in addition, provide FDA with information that we can use to focus and better utilize our limited inspection resources.

Summary of the Major Provisions of the Proposed Rule

Section 102 of FSMA amends section 415 of the FD&C Act by requiring that certain additional information be included in registrations. More specifically, section 102(a)(1)(A) of FSMA amends section 415 to provide that registrations for domestic food facilities are required to contain the email address for the contact person of the facility, and registrations for foreign food facilities are required to contain the email address of the U.S. agent for the facility. Further, section 102(a)(3) of FSMA amends section 415 to provide that food facilities required to register with FDA must renew their registrations with FDA every 2 years, between October 1 and December 31 of each even-numbered year, by submitting registration renewals to FDA. Also, section 102(b)(1)(A) of FSMA provides that all food facility registrations are required to contain an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act. These FSMA amendments were self-implementing and became effective upon enactment of FSMA. These FSMA amendments are being included in this proposed rule to codify the provisions in the food facility registration regulations in 21 CFR part 1, subpart H.

In addition, section 102(b) of FSMA authorizes FDA to require that all food facility registrations be submitted to FDA in an electronic format; however, such requirement cannot take effect before the date that is 5 years after the date of enactment of FSMA (
i.e.,
January 4, 2016). We are proposing to implement this provision in this proposed rule.

Section 102(c) of FSMA also directs FDA to amend the definition of the term “retail food establishment” in § 1.227(b)(11) of title 21, Code of Federal Regulations to clarify that, in determining the primary function of an establishment or a retail food establishment under such section, the sale of food products directly to consumers by such establishment and the sale of food directly to consumers by such retail food establishment include: (1) The sale of food products or food directly to consumers by such establishment at a roadside stand or farmers' market where such stand or market is located other than where the food was manufactured or processed; (2) the sale and distribution of such food through a community supported agriculture program; and (3) the sale and distribution of such food at any other such direct sales platform as determined by the Secretary. We are proposing to implement these provisions in this proposed rule.

Lastly, we are proposing changes to improve the utility of the food facility registration database. We are proposing, among other things, to: (1) Require

certain additional data elements in food facility registrations; (2) employ additional measures to verify certain information submitted in registrations; and (3) take additional steps to ensure that our registration database is up-to-date by identifying additional circumstances under which FDA will cancel registrations.

Costs and Benefits

Costs of meeting the proposed requirements of this rule will be incurred by both FDA and food facilities that are required to register. Table 1 presents estimated costs associated with the provisions in this proposed rule. Estimated one-time costs to domestic and foreign facilities are about $22 million. Annualized costs are calculated using a discount rate of 7 percent and 3 percent over 20 years. Total annualized costs to food facilities, which include annualized one-time costs and annualized recurring costs, are approximately $5 million and $6 million. Annualized recurring costs to FDA are approximately $1 million, using both discount rates. We expect that the benefits of the proposed rule would include aiding FDA's ability to deter and limit the effects of foodborne outbreaks and other food-related emergencies. Although we are unable to quantify these and other benefits, we discuss the expected benefits qualitatively in the preliminary regulatory impact analysis (PRIA).

Table 1—Annualized Cost and Benefit Summary
[$Millions]

Total one time costs
Total annualized costs 7%
Total annualized costs 3%
Benefits

Domestic Facilities
$9
$1
$1
Not Quantified.

Foreign Facilities
13
4
5

Subtotal Facilities
22
5
6

Costs to FDA

1
1

Total
22
6
7

Table of Contents

I. Background

A. The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and FDA's Current Regulations for Registration of Food Facilities

B. The FDA Food Safety Modernization Act and Food Facility Registration

C. Rulemaking Required by Section 103(c) of FSMA: On-Farm Activities

II. Legal Authority

III. The Proposed Rule

A. Proposed Amendments to Registration of Food Facilities Under FSMA

B. Other Proposed Amendments to Registration of Food Facilities

C. Request for Comment on Establishment of a U.S. Agent Voluntary Identification System

IV. Preliminary Regulatory Impact Analysis

A. Overview

B. Regulatory Flexibility Act

C. Unfunded Mandates Reform Act of 1995

D. Public Access to the Analyses

V. Paperwork Reduction Act of 1995

VI. Analysis of Environmental Impact

VII. Federalism

VIII. Request for Comments

IX. References

I. Background

A. The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and FDA's Current Regulations for Registration of Food Facilities

After the events of September 11, 2001, highlighted the need to enhance the security of the infrastructure of the United States, including the food supply, Congress responded by enacting the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) (Pub. L. 107-188), which was signed into law on June 12, 2002. The Bioterrorism Act included a provision in Title III (Protecting Safety and Security of Food and Drug Supply), Subtitle A—Protection of Food Supply, section 305, which required the Secretary of Health and Human Services (the Secretary) to develop a regulation to require domestic and foreign facilities that manufacture, process, pack, or hold food for consumption in the United States to register with FDA by December 12, 2003. The provision created section 415 and amended sections 301 and 801 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 331 and 381). Section 415 of the FD&C Act, as added by the Bioterrorism Act, generally requires food facilities to register with FDA by submitting certain information to the Agency and updating such information as necessary. Section 301(dd) of the FD&C Act provides that failure to register in accordance with section 415 of the FD&C Act is a prohibited act. Section 801(l) of the FD&C Act, as added by the Bioterrorism Act, generally provides that an article of food imported or offered for import into the United States from a foreign facility for which a registration has not been submitted to FDA under section 415 shall be held at the port of entry for the article.

The Secretary and the Department of Treasury (Treasury) jointly issued a proposed rule for food facility registration (2003 proposed rule) in the
Federal Register
on October 10, 2003 (68 FR 58894). On October 10, 2003, the Secretary and the Department of Homeland Security (DHS) jointly issued an interim final rule for registration of food facilities under the Bioterrorism Act.
1

The interim final rule implemented section 305 of the Bioterrorism Act, and required domestic and foreign facilities to be registered with FDA by December 12, 2003 (68 FR 58894). On October 3, 2005, FDA issued a final rule in the
Federal Register
(70 FR 57505) that confirmed the interim final rule entitled “Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.” FDA's implementing regulation for section 415 of the FD&C Act is codified in part 1 (21 CFR part 1), subpart H. Highlights of FDA's current registration of food facilities regulation are as follows:

1
The authorities of Treasury under section 701(b) of the FD&C Act (21 U.S.C. 371(b)) to jointly prescribe regulations with the Department of Health and Human Services for the efficient enforcement of section 801 of the FD&C Act were transferred to DHS when DHS was created by an act of Congress in 2002.

• The owner, operator, or agent in charge of a domestic or foreign facility engaged in manufacturing/processing, packing, or holding food for consumption by humans or animals in

the United States is required to register the facility with FDA.

• The owner, operator, or agent in charge of a facility that is required to register may authorize an individual to register the facility on its behalf.

• Facilities covered under the interim final rule had to be registered by December 12, 2003.

• A foreign facility is exempt from registering if food from the facility undergoes further manufacturing/processing (including packaging) by another facility outside the United States. The foreign facility is not exempt from registration if the further manufacturing/processing (including packaging) activities of the subsequent facility are limited to affixing a label to a package or other de minimis activity.

• The following domestic and foreign facilities are also excluded from the registration requirement: Farms; retail food establishments; restaurants; nonprofit food establishments in which food is prepared for, or served directly to, the consumer; certain fishing vessels not engaged in processing; and facilities regulated exclusively, throughout the entire facility, by the U.S. Department of Agriculture (USDA) under the Federal Meat Inspection Act (21 U.S.C. 601,
et seq.
), the Poultry Products Inspection Act (21 U.S.C. 451,
et seq.
), or the Egg Products Inspection Act (21 U.S.C. 1031,
et seq.
).

• Registrants must use Form FDA 3537 to register. This form is available either on the Internet or via mail or phone request. Registrants must use Form FDA 3537(a) to cancel their registrations.

• FDA strongly encourages electronic registration, which is quicker and more convenient for both facilities and FDA than registration by mail.

• To register electronically, a registrant may visit
http://www.fda.gov/furls,
which is available for registration 24 hours a day, 7 days a week. This Web site is available from wherever the Internet is accessible, including libraries, copy centers, schools, and Internet cafes, as well as through a foreign facility's U.S. agent or other authorized individual if the facility makes such arrangements.

• Regardless of the method of submission (paper or electronic), each registration must include the names, full addresses, and phone numbers for the facility, its parent company (if applicable), and the owner, operator and agent in charge; for a foreign facility, the name, address, and phone number, and, if no emergency contact is designated, the emergency contact phone number of the foreign facility's U.S. agent; for a domestic facility, an emergency contact phone number; all trade names the facility uses; applicable food product categories as identified in § 170.3 (21 CFR 170.3); and a statement certifying that the information submitted is true and accurate and, if the individual submitting the registration is not the owner, operator, or agent in charge of the facility, a statement in which the individual certifies that he/she is authorized to submit the registration.

• No registration fee is required.

• Updates to registration information or cancellation of registration must be submitted within 60 calendar days of any change to any of the required information previously submitted, except a change of the owner.

• If a facility has a new owner, the former owner must cancel the facility's registration within 60 calendar days of the change and the new owner must re-register the facility.

• Failure of a domestic or foreign facility to register, update, or cancel its registration in accordance with the regulation is a prohibited act under section 301(dd) of the FD&C Act.

• FDA will cancel a registration if the Agency independently verifies that the facility is no longer in business or has changed owners, and the owner, operator, or agent in charge of the facility fails to cancel the registration, or if FDA determines that the registration is for a facility that does not exist.

• The disposition of food imported or offered for import from an unregistered foreign facility is governed by the procedures set out in subpart I of part 1 (21 CFR part 1) (Prior Notice of Imported Food).

• Assignment of a registration number to a facility means that the facility is registered with FDA. Assignment of a registration number does not in any way convey FDA's approval or endorsement of a facility or its products.

• The list of registered facilities and registration documents submitted are not subject to public disclosure under 5 U.S.C. 552 (the Freedom of Information Act). Information derived from this list or these documents is also not subject to such disclosure to the extent that it discloses the identity or location of a specific registered facility.

B. The FDA Food Safety Modernization Act and Food Facility Registration

The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353), signed into law on January 4, 2011, enables FDA to better protect public health by helping to ensure the safety and security of the food supply. Section 102 of FSMA, entitled Registration of Food Facilities, amends section 415 of the FD&C Act regarding requirements for food facility registration along with other sections of the FD&C Act involving food facility registration. Further, other sections of FSMA include amendments that apply to facilities that are required to register under section 415 of the FD&C Act.

1. Section 102 of FSMA: Registration of Food Facilities

Section 102 of FSMA includes a number of amendments to food facility registration requirements or sections of the FD&C Act involving food facility registration. First, section 102 of FSMA amends section 415 by requiring that certain additional information be included in registrations. More specifically, section 102(a)(1)(A) of FSMA amends section 415 to provide that registrations for domestic food facilities are required to contain the email address for the contact person of the facility, and registrations for foreign food facilities are required to contain the email address of the U.S. agent for the facility. Also, section 102(b)(1)(A) of FSMA provides that all food facility registrations are required to contain an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act. These FSMA amendments were self-implementing and became effective upon enactment of FSMA. These FSMA amendments are being included in this proposed rule to codify the provisions in the registration of food facilities regulations in 21 CFR part 1, subpart H.

Second, section 102 of FSMA amends section 415 with respect to updating food product category information required in food facility registrations. Before FSMA was enacted, section 415(a)(2) of the FD&C Act, as added by section 305 of the Bioterrorism Act, provided in relevant part that, when determined necessary by FDA “through guidance,” a registrant must submit a registration to FDA containing information necessary to notify FDA of the general food category (as identified in § 170.3) of food manufactured, processed, packed, or held at such facility. On July 17, 2003, FDA issued a guidance document stating that FDA had determined that the inclusion of food product categories in food facility registrations was necessary for a quick, accurate, and focused response to an actual or potential bioterrorist incident or other food-related emergency (see 68 FR 42415). Section 102(a)(1)(B) of FSMA amends section 415(a)(2) of the FD&C Act with respect to food product category information by authorizing FDA to determine other food product categories, including those not

specifically identified in § 170.3. Specifically, section 415(a)(2) of the FD&C Act, as amended by section 102(a)(1)(B) of FSMA, provides in relevant part that, when determined necessary by FDA “through guidance,” a registrant is required to submit a registration to FDA containing information necessary to notify FDA of the general food category (as identified in § 170.3 or any other food categories, as determined appropriate by FDA, including by guidance) of any food manufactured, processed, packed, or held at such facility. In October 2012, FDA issued a guidance entitled “Guidance for Industry: Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories.” This guidance represents FDA's conclusion on the necessity of food product categories in food facility registrations and identifies other food product categories that are necessary and appropriate for food facility registration, as provided by section 415(a)(2) of the FD&C Act.

Third, section 102(a)(3) of FSMA amends section 415 to provide that food facilities required to register with FDA must renew their registrations with FDA every 2 years, between October 1 and December 31 of each even-numbered year, by submitting registration renewals to FDA. Further, section 102(a)(3) of FSMA directs FDA to provide for an abbreviated registration renewal process for any registrant that has not had any changes to such information since the registrant submitted the preceding registration or registration renewal for the facility.

Fourth, section 102(b) of FSMA amends section 415(b) of the FD&C Act by adding new provisions authorizing FDA to suspend the registration of a food facility in certain circumstances. Specifically, if FDA determines that food manufactured, processed, packed, received, or held by a registered facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals, FDA may by order suspend the registration of a facility that created, caused, or was otherwise responsible for such reasonable probability; or knew of, or had reason to know of, such reasonable probability and packed, received, or held such food. Under section 415(b)(4) of the FD&C Act, as amended by section 102(b) of FSMA, if the registration of a food facility is suspended, no person can import or export, or offer to import or export, food from the facility into the United States, or otherwise introduce food from the facility into interstate or intrastate commerce in the United States. Under section 301(d) of the FD&C Act, as amended by section 102(b) of FSMA, the introduction or delivery for introduction into interstate commerce of an article of food in violation of section 415 is a prohibited act. Further, section 801(l) of the FD&C Act, as amended by section 102(b) of FSMA, provides, in relevant part, that an article of food being imported or offered for import into the United States that is from a foreign facility for which a registration has been suspended under section 415 must be held at the port of entry for the article of food, and may not be delivered to the importer, owner, or consignee of the article. FDA intends to address the suspension of registration provisions in section 102(b) of FSMA in a separate rulemaking.

Section 102(b) of FSMA also authorizes FDA to require that all food facility registrations be submitted to FDA in an electronic format; however, such requirement cannot take effect before the date that is 5 years after the date of enactment of FSMA (
i.e.,
January 4, 2016).

Lastly, section 102(c) of FSMA directs FDA to amend the definition of the term “retail food establishment” in § 1.227(b)(11) of title 21, Code of Federal Regulations to clarify that, in determining the primary function of an establishment or a retail food establishment under such section, the sale of food products directly to consumers by such establishment and the sale of food directly to consumers by such retail food establishment include: (1) The sale of food products or food directly to consumers by such establishment at a roadside stand or farmers' market where such stand or market is located other than where the food was manufactured or processed; (2) the sale and distribution of such food through a community supported agriculture program; and (3) the sale and distribution of such food at any other such direct sales platform as determined by the Secretary. As discussed more fully in the paragraphs that follow, we are proposing to implement these provisions in this proposed rule.

2. Other FSMA Amendments Involving Food Facilities Required To Register Under Section 415 of the FD&C Act

In addition to amending section 415 of the FD&C Act and the other related sections of the FD&C Act as discussed in the preceding section, FSMA also amended the FD&C Act such that section 415 functions in connection with other food safety provisions. For instance, FSMA added section 418 of the FD&C Act (21 U.S.C. 350g), which establishes certain preventive control requirements for food facilities that are required to register under section 415. In general, section 418(a) requires the owner, operator, or agent in charge of a “facility” to evaluate the hazards that could affect food manufactured, processed, packed, or held by such facility, identify and implement preventive controls, monitor the performance of those controls, and maintain records of the monitoring. The term “facility” is defined in section 418(
o
)(2) as “a domestic facility or a foreign facility that is required to register under section 415.”

In addition, section 201(a) of FSMA created section 421 of the FD&C Act (21 U.S.C. 350j), which also ties to section 415. In particular, section 421 requires the Agency to identify high-risk “facilities” and mandates more frequent inspections for domestic high-risk “facilities” than for domestic non-high-risk facilities. Section 421 also includes an inspection mandate for foreign facilities. For the purposes of section 421, the term “facility” refers to facilities that are required to register under section 415. (See section 421(e)). In addition, section 306 of FSMA added section 807(a)(1) of the FD&C Act (21 U.S.C. 384c(a)(1)), which provides that FDA may enter into arrangements and agreements with foreign governments to facilitate the inspection of foreign facilities registered under section 415.

FSMA also created section 423 of the FD&C Act (21 U.S.C. 350
l
), which provides a “responsible party” an opportunity to voluntarily cease distribution and recall a food under specified circumstances and also provides FDA with authority to mandate a recall under specified circumstances. The term “responsible party” is defined by reference to the definition in section 417 of the FD&C Act (21 U.S.C. 350f), which in turn defines that term as a person that submits the registration under section 415(a) of the FD&C Act for a food facility that is required to register under section 415(a) of the FD&C Act, at which such article of food is manufactured, processed, packed, or held. (See section 417(a)(1) of the FD&C Act.) In addition, FSMA created section 808 of the FD&C Act (21 U.S.C. 384d), which provides for the recognition of accreditation bodies that accredit third-party auditors to conduct food safety audits of foreign food entities, including foreign food facilities registered under section 415.

Further, section 107 of FSMA amended the FD&C Act to provide FDA with the authority to collect fees related to reinspections of facilities required to register under section 415 of the FD&C Act. Specifically, section 107 of FSMA

added section 743(a)(1)(A) of the FD&C Act (21 U.S.C. 379j-31(a)(1)(A)), which provides FDA with the authority to assess and collect fees from domestic facilities (as defined in section 415(b) of the FD&C Act) and U.S. agents for foreign facilities (also as defined in section 415(b) of the FD&C Act) subject to reinspection to cover reinspection-related costs.

FSMA is not the only act in which Congress has linked food facility registration to specific food safety requirements. The Food and Drug Administration Amendments Act of 2007 (FDAAA) also tied food safety requirements to food facility registration. FDAAA amended the FD&C Act by creating section 417, which generally requires a “responsible party” to submit a report to FDA through the Reportable Food Registry after determining that an article of food is a reportable food as defined in section 417(a)(2) and further defined in section 201(ff) of the FD&C Act (21 U.S.C. 321(ff))). As stated previously, section 417 of the FD&C Act defines the term “responsible party” as a person that submits the registration under section 415(a) of the FD&C Act for a food facility that is required to register under section 415(a) of the FD&C Act, at which such article of food is manufactured, processed, packed, or held. (See section 417(a)(1) of the FD&C Act.)

As a result of these links between food facility registration and additional requirements in the FD&C Act, food facility registration now serves additional functions to those originally identified in the food facility registration regulations issued in 2003 and finalized in 2005 (68 FR 58894; 70 FR 57505). More specifically, the interim final rule noted that food facility registration would help FDA act quickly in responding to a threatened or actual bioterrorist attack on the U.S. food supply or to other food-related emergencies (68 FR 58894 at 58895). It also noted that registration would provide FDA with information about food facilities that would help FDA and other authorities determine the source and cause of an outbreak of foodborne illness, while also enabling FDA to notify more quickly the facilities that might be affected by the outbreak (68 FR 58894 at 58895). While food facility registration continues to serve all of those functions, with the passage of FSMA and FDAAA, food facility registration now also serves to determine the applicability of provisions in other sections of the FD&C Act, including sections 417, 418, 421, 423, 743, 807, and 808 of the FD&C Act. Thus, food facility registration now relates to many more food safety requirements than when the system was first implemented in 2003.

C. Rulemaking Required by Section 103(c) of FSMA: On-Farm Activities

Section 103(c)(1)(A) of FSMA, regarding Hazard Analysis and Risk-Based Preventive Controls, requires that the Secretary publish a notice of proposed rulemaking in the
Federal Register
to issue regulations with respect to “activities that constitute on-farm packing or holding of food that is not grown, raised, or consumed on such farm or another farm under the same ownership” and “activities that constitute on-farm manufacturing or processing of food that is not consumed on that farm or on another farm under common ownership” within the context of section 415 of the FD&C Act. Section 103(c)(1)(B) of FSMA provides that such rulemaking will “enhance the implementation of . . . section 415 and clarify the activities that are included as part of the definition of the term ‘facility’ under such section 415.” In the
Federal Register
of January 16, 2013 (78 FR 3646), we published a proposed rule entitled “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food” to implement section 103 of FSMA and we discuss our proposal to revise the registration of food facilities regulations (part 1, subpart H) as specified by section 103(c)(1) of FSMA. In the
Federal Register
of September 29, 2014 (79 FR 58524), we published a supplemental notice of proposed rulemaking to amend the 2013 preventive controls proposed rule. That proposed rule is a separate rulemaking and not the subject of this rulemaking.

II. Legal Authority

We are issuing this proposed rule under the FD&C Act, FSMA, and the Bioterrorism Act. We are proposing to codify the requirements of section 102 of FSMA that were self-implementing and effective upon enactment of FSMA, as discussed previously, in the Registration of Food Facilities Regulation (part 1, subpart H). In addition, we are proposing to implement other requirements of section 102 of FSMA, as discussed previously, including mandatory electronic registration submissions beginning in 2016 and amendments to the retail food establishment definition. Lastly, we are proposing other changes to improve the utility of the food facility registration database.

FDA's legal authority to implement requirements of section 102 of FSMA derives from section 102 of FSMA and sections 415, 301(dd), 801(l), and 701(a) of the FD&C Act. As discussed previously, section 415 of the FD&C Act requires food facilities that manufacture/process, pack, or hold food for consumption in the United States to register with FDA by submitting certain information to the Agency and updating such information as necessary. Section 415(a)(2) of the FD&C Act, as amended by section 102 of FSMA, requires, in relevant part, food facility registrations to include additional information, including the email addresses of contact persons for domestic facilities and U.S. agents for foreign facilities; an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act; and updated food product category information, if determined necessary and appropriate by FDA. Further, section 415(a)(3) of the FD&C Act, as amended by section 102 of FSMA, requires, in relevant part, food facilities required to register to renew their registrations with FDA between October 1 and December 1 of each even-numbered year, and directs FDA to provide for an abbreviated registration renewal process for registrants that have not had any changes to registration information since the registrant submitted the preceding registration or registration renewal for the facility involved. Section 301(dd) of the FD&C Act provides that failure to register in accordance with section 415 of the FD&C is a prohibited act. Section 801(l) of the FD&C Act provides that an article of food being imported or offered for import into the United States that is from a foreign facility for which a registration has not been submitted to FDA under section 415 (or for which a registration has been suspended under such section) must be held at the port of entry for the article of food, and may not be delivered to the importer, owner, or consignee of the article until the foreign facility is so registered. Section 701(a) of the FD&C Act authorizes FDA to issue regulations for the efficient enforcement of the FD&C Act. As discussed previously, section 102(c) of FSMA also directs FDA to amend the definition of the term “retail food establishment” in FDA's Registration of Food Facilities Regulation at § 1.227(b)(11).

As discussed in detail in the paragraphs that follow, FDA is proposing additional required data elements in food facility registrations to provide for more efficient and effective communications during a public health emergency and to provide FDA information that we can use to focus

and better deploy the Agency's limited inspectional resources. FDA's legal authority to implement these and other changes to improve the utility of the food facility registration database also derives from section 102 of FSMA and the sections of the FD&C Act described in the previous paragraph. Section 415(a)(2) of the FD&C Act requires foreign facilities to submit registrations to FDA that include the name of the U.S. agent for the facility. Further, FDA is relying on section 107 of FSMA and sections 421 and 704 (21 U.S.C. 374) of the FD&C Act in issuing these proposed changes. Section 107 of FSMA amended the FD&C Act to provide FDA with the authority to assess and collect certain fees from,
inter alia,
U.S. agents for foreign facilities (as defined in section 415(b) of the FD&C Act) subject to reinspection to cover reinspection-related costs. Section 704 gives FDA the authority to inspect factories, warehouses, and other establishments in which foods are manufactured, processed, packed, or held. Section 421 of the FD&C Act requires the Agency to identify high-risk facilities and mandates more frequent inspections for domestic high-risk facilities than for domestic non-high-risk facilities. FDA is also relying on section 305(d) of the Bioterrorism Act (Pub. L. 107-188), which directs FDA, in relevant part, to ensure adequate authentication protocols are used to enable identification of the registrant and validation of the registration data, as appropriate, for registrations submitted to FDA electronically. Thus, FDA has the authority to issue this proposed rule under section 305 of the Bioterrorism Act, sections 102 and 107 of FSMA, and sections 301(dd), 415,701(a), and 704 of the FD&C Act.

III. The Proposed Rule

This proposed rule would revise FDA's current regulations in part 1, subpart H, regarding registration of food facilities in two fundamental ways. First, it would add new provisions to the current regulations to implement certain provisions of section 102 of FSMA or otherwise codify amendments of section 102 of FSMA that were self-implementing and effective upon enactment of FSMA, as discussed previously. Second, we are proposing changes to improve the utility of the food facility registration database. We are proposing to do this by proposing, among other things, to: (1) Require certain additional data elements in food facility registrations; (2) employ additional measures to verify certain information submitted in registrations; and (3) take additional steps to ensure that our registration database is up to date by identifying additional circumstances under which FDA will cancel registrations. The following description of the proposed rule describes both new provisions and changes to the existing regulations in part 1, subpart H.

A. Proposed Amendments to Registration of Food Facilities Under FSMA

1. Retail Food Establishment Definition

Under section 415 of the FD&C Act and FDA's registration regulation (21 CFR 1.226(c)), a retail food establishment is not required to register with FDA. A “retail food establishment” is defined in current § 1.227(b)(11) to mean an establishment that sells food products directly to consumers as its primary function. Under current § 1.227(b)(11), a retail food establishment may manufacture/process, pack, or hold food if the establishment's primary function is to sell from that establishment food, including food that it manufacturers/processes, packs, or holds, directly to consumers. A retail food establishment's primary function is to sell food directly to consumers if the annual monetary value of sales of food products directly to consumers exceeds the annual monetary value of sales of food products to all other buyers. The definition of retail food establishment also provides that the term “consumers” does not include businesses, and a “retail food establishment” includes grocery stores, convenience stores, and vending machine locations.

Section 102(c) of FSMA directs FDA to amend the definition of “retail food establishment” to clarify that, in determining the primary function of an establishment, the sale of food directly to consumers by such establishment includes: (1) The sale of food directly to consumers by such establishment at a roadside stand or farmers' market where such stand or market is located other than where the food was manufactured or processed; (2) the sale and distribution of such food through a community supported agriculture program; and (3) the sale and distribution of such food at any other such direct sales platform as determined by the Secretary.

The proposed amendment to the retail food establishment definition addresses off-farm sales by an establishment located on a farm. How these off-farm sales relate to an establishment's status as a retail food establishment is significant because if manufacturing/processing activities on a farm are part of a retail food establishment, they do not trigger the requirement to register. Otherwise, unless all food used in such activities is consumed on that farm or another farm under the same ownership, the manufacturing/processing operation is required to register (see § 1.227(b)(3)(ii)). If all sales from an on-farm manufacturing/processing operation must be made on-farm for that operation to qualify as a retail food establishment, then an on-farm establishment that sells processed food at a direct sales platform such as a farmer's market could not qualify as a retail food establishment and would be required to register. To prevent this, proposed § 1.227(b)(11) clarifies that all sales by an on-farm establishment do not have to be on the farm by specifically addressing how off-farm sales directly to consumers are to be counted in determining whether the on-farm establishment is a retail food establishment.

a. Sale of food directly to consumers at a roadside stand or farmers' market.
Under proposed § 1.227(b)(11)(i), in determining the primary function of an establishment located on a farm, the sale of food directly to consumers from such establishment would include the sale of food directly to consumers by such establishment at a roadside stand or farmers' market. The roadside stand or farmer's market would not need to be on the farm where the establishment is located. For example, an establishment located on a farm that sells jams and jellies it manufacturers, along with produce it grows, directly to consumers at a farmers' market would consider those sales in determining its primary function and thus whether it would meet the requirements to be considered a retail food establishment. Note that whether the farmers' market would be a retail food establishment involves a separate primary function calculation involving only sales made at the farmers' market and would not include, for example, sales at the farm. This analysis is not affected by the proposed amendment and is similar to how primary function would be determined at a grocery or convenience store.

FDA is proposing that a farmers' market is a location where one or more local farmers assemble to sell from their farms directly to consumers. FDA is proposing that a roadside stand is a stand situated on the side of or near a road or thoroughfare at which a farmer sells food from his or her farm directly to consumers. These definitions are based on definitions found in 7 CFR 249.2, with modifications to more specifically describe foods sold by on-farm establishments at direct sales

platforms such as roadside stands and farmers' markets. We seek comments on this proposed amendment, and specifically, what, if any, limitations should be included such as distance of the roadside stand or farmers' market from the farm, for example, not more than 275 miles from the farm. In addition, we seek comments on the proposed definitions for farmers' market and roadside stand and if any of the terms within these proposed definitions should be further defined.

b. Sale and distribution of food through a community supported agriculture program.
Under proposed § 1.227(b)(11)(ii), in determining the primary function of an establishment located on a farm, the sale of food directly to consumers from such establishment would also include the sale and distribution of such food through a community supported agriculture program. For example, an establishment located on a farm that sells apples it grows and apple pies it manufacturers directly to consumers through a CSA would consider those sales in determining its primary function and thus whether it would meet the requirements to be considered a retail food establishment.

Section 102(c) of FSMA provides that for the purposes of the retail food establishment definition, “the term `community supported agriculture program' has the same meaning given the term `community supported agriculture (CSA) program' in section 249.2 of title 7, Code of Federal Regulations (or any successor regulation).” Under 7 CFR 249.2, a “community supported agriculture (CSA) program” means “a program under which a farmer or group of farmers grows food for a group of shareholders (or subscribers) who pledge to buy a portion of the farmer's crop(s) for that season. State agencies may purchase shares or subscribe to a community supported agriculture program on behalf of individual SFMNP [Senior Farmers' Market Nutrition Program] participants.” Accordingly, we are proposing that the term “community supported agriculture program” in proposed § 1.227(b)(11) have the same meaning used for the term in 7 CFR 249.2. We note that, under proposed § 1.227(b)(11)(ii), a CSA program would include CSA programs in which a group of farmers consolidate their crops at a central location for distribution to shareholders or subscribers.

c. Sale and distribution of food at any other direct-to-consumer sales platforms.
Under proposed § 1.227(b)(11)(iii), in determining the primary function of an establishment located on a farm, the sale of food directly to consumers from such establishment would include the sale and distribution of such food at other direct-to-consumer sales platforms, including door-to-door sales; mail, catalog and Internet orders, including online farmers markets and online grocery delivery; religious or other organization bazaars, and State and local fairs. The specified direct sales platforms are common platforms for direct-to-consumer sales of foods from farms, and to the extent that such platforms typically provide direct-to-consumer sales of food from local farms, they are similar to farmers' markets and CSAs. We seek comments on the direct sales platforms we have specified and what, if any, other such direct sales platforms we should specify.

d.
Other issues.
As proposed, this amendment to the retail food establishment definition would be limited to on-farm establishments. We believe such a limitation is consistent with section 102(c) of FSMA, which addresses the sale of foods directly to consumers at specific locations (
i.e.,
roadside stands, farmers' markets, and community supported agriculture programs) where the food for sale directly to consumers is sourced directly from farms. We request comment on whether such a limitation is appropriate.

Further, proposed § 1.227(b)(11) provides for considering certain off-farm sales directly to consumers when determining an on-farm establishment's primary function, but does not provide for considering off-farm sales to businesses in the primary function calculation. In doing so, the proposal reflected section 102(c) of FSMA, which addresses only sales to consumers. We request comment on whether, in addition to implementing the specific clarification in section 102(c), we should provide that off-farm sales to businesses also be considered in determining the primary function of an on-farm establishment.

In addition, proposed § 1.227(b)(11) provides for, in determining the primary function of an on-farm establishment, considering the off-farm sales of “food” directly to consumers, which would include both food that has been manufactured/processed and food that has not (raw agricultural commodities). FDA requests comment on whether, in light of the reference to “other than where the food was manufactured or processed” in section 102(c)(1)(A) of FSMA or for other reasons, only the sale of processed foods off the farm should be considered in determining the primary function of an establishment located on a farm.

2. Biennial Registration Renewal and Abbreviated Registration Renewal Process

Section 415(a)(3) of the FD&C Act, as amended by section 102(a) of FSMA, requires that during the period beginning on October 1 and ending on December 31 of each even-numbered year, a registrant that has submitted a registration to FDA under section 415(a)(1) of the FD&C Act must submit to FDA a renewal registration containing the information described in section 415(a)(2) of the FD&C Act. This requirement went into effect upon enactment of FSMA. Food facilities were required to renew their registrations with FDA after the enactment of FSMA during the 2012 registration renewal period.

Proposed § 1.230(b) would require the owner, operator, or agent in charge of a facility to submit a registration renewal to FDA containing the information required under § 1.232 every other year, during the period beginning on October 1 and ending on December 31 of each even-numbered year. Under proposed § 1.230(b), the owner, operator, or agent in charge of a facility may authorize an individual to renew the facility's registration on its behalf. As discussed in section III.B.12.b, we are proposing to replace “the owner, operator, or agent in charge of a facility” with “you” throughout the regulation because “you” is defined in the regulation under current § 1.227(b)(14) to mean the owner, operator, or agent in charge of a facility that manufactures/processes, packs, or holds food for consumption in the United States.

Section 415(a)(3) of the FD&C Act, as amended by section 102(a)(3) of FSMA, directs FDA to provide for an abbreviated registration renewal process for any registrant that has not had any changes to its registration information since the registrant submitted the preceding registration or registration renewal for the facility. Proposed § 1.230(c) would provide for an abbreviated registration renewal process for registrations that do not have any changes to the information required under § 1.232 since the registrant submitted the preceding registration or registration renewal for the facility to FDA. The abbreviated registration renewal process would require a registrant to confirm that no changes have been made to the information required in the registration since the registrant submitted the preceding registration or registration renewal, confirm that FDA will be permitted to

inspect the facility at the times and in the manner permitted by the FD&C Act, and certify that the information submitted is truthful and accurate. FDA is proposing that registrants must use Form FDA 3537 to submit abbreviated registration renewals to FDA. This form will be available electronically at
www.fda.gov
or via mail or phone request until mandatory electronic registration and registration renewals begin in the 2016 registration renewal period, as described in proposed § 1.231(a)(2).

Proposed § 1.230(b) would codify in FDA's registration regulation the biennial registration renewal requirement of section 415(a)(3) of the FD&C Act (as added by section 102(a)(3) of FSMA), which is already in effect. Proposed § 1.230(c) would implement the provision of section 415(a)(3) of the FD&C Act providing for an abbreviated registration renewal process for registrants that have not had any changes to required registration information since such registrations submitted the preceding registration or registration renewal for the facility involved. The abbreviated registration renewal process was not available for the 2012 registration renewal period because section 102(a) of FSMA established new registration data elements, meaning all registrants would have had changes to their registration information since such registrations were previously submitted or updated.

3. Mandatory Electronic Submission of Food Facility Registration and Registration Renewals

Section 415(b)(5)(B) of the FD&C Act, as added by section 102(b) of FSMA, provides that FDA may require that registration under section 415 be submitted to FDA in an electronic format. However, section 415(b)(5)(B) specifies that such requirement may not take effect before the date that is 5 years after the date of enactment of FSMA, which is January 4, 2016. Proposed § 1.231(a)(2) would provide that beginning January 4, 2016, electronic registration will be mandatory, unless a waiver has been granted for the registrant. In addition, proposed § 1.231(a)(2) would require mandatory electronic registration renewals beginning in the 2016 registration renewal period. Proposed § 1.231(b) would also provide that beginning January 4, 2016, registration or registration renewals by mail or fax would no longer be permitted, unless a waiver has been granted for the registrant. Such waivers are further discussed in section III.B.11.

FDA tentatively concludes that mandatory electronic submission of registration and registration renewals would provide a number of advantages over submission of registration and registration renewals on the FDA paper form, including the following:

• The mandatory electronic system would improve the timeliness and accuracy of submissions.

• The electronic transmission of information would be easier and more efficient for both industry and FDA than the use of paper forms. For example, a registrant would receive onscreen feedback if the information submitted was not complete, reducing errors and time and cost of communicating with FDA. Similarly, electronic transmission of the information would reduce significantly the time and cost associated with processing paper forms and communicating with industry concerning errors on those forms.

• Information search and retrieval time would be reduced, allowing quicker access to the information in the database.

• FDA has strongly encouraged electronic registration for the benefit of both FDA and the registrant. FDA tentatively concludes that the majority of facilities, both in the United States and abroad, have access to the Internet, either within their facilities or parent companies or through public libraries, copy centers, schools, or Internet cafes, as well as through a foreign facility's U.S. agent if the facility makes such arrangements. If the U.S. agent does not have Internet access onsite, the agent may register the facility electronically from a local library or other public facility that offers Internet access.

• FDA is able to accept electronic registrations from anywhere in the world where the Internet is available 24 hours a day, 7 days a week.

• Electronic registration also enables a facility to be registered more quickly than if registering by mail. Registration by mail can take several weeks to several months, depending on the efficiency of the mail system, the number of paper registrations that FDA would need to enter manually into the system, whether the Agency would have to return an incomplete or illegible form to a registrant, and because FDA would have to subsequently mail the registration number and receipt of registration to the registrant.

We are seeking comments on the proposed requirements for mandatory electronic registration and registration renewals to begin in the year 2016. We are also requesting comments and data on the number of facilities, if any, that believe they would be unable to register or renew their registrations electronically, and the reasons for such belief, such as, no access to the Internet or for religious beliefs. In addition, as further discussed in section III.B.11, we are seeking comments on our proposal to allow for a waiver from the requirement for mandatory registration and registration renewals beginning in 2016.

4. Email Address for the Contact Person as Required Information

Section 415(a)(2) of the FD&C Act, as amended by section 102(a) of FSMA, requires, among other things, that a registration for a domestic facility contain the email address for the contact person of the facility. This requirement went into effect upon enactment of FSMA. Proposed § 1.232(b)(1) would require the email address for the contact person of a domestic facility be included in the registration. Proposed § 1.232(b)(1) would codify in FDA's registration regulation the requirement of section 415(a)(2) of the FD&C Act that a registration for a domestic facility contain the email address for the contact person of the facility.

FDA has received questions from some registrants related to the requirement that a registration for a domestic facility include the email address for the contact person of the facility. Specifically, some registrants have indicated that they are unable to obtain email addresses or otherwise use computers or similar electronic devices because of their religious beliefs. While section 415(a)(2) of the FD&C Act requires a registration for a domestic food facility to include the email address for the contact person of the facility, such contact person is not required to be the owner, operator, or agent in charge. Accordingly, a registrant can provide the email address of a third-party contact person in a registration (to be used for email communications between FDA and the facility), meaning that the registrant would not be required to obtain an email address or otherwise use a computer or similar electronic device within this context.

As further discussed throughout this document, it is critical that FDA be able to contact facilities in a quick manner in the event of a threatened or actual terrorist attack, an outbreak of foodborne illness, or other food-related emergency. Moreover, section 415(a)(2) of the FD&C Act, as amended by FSMA, specifically requires domestic facilities to submit the email addresses of contact persons in food facility registrations. For these reasons, FDA tentatively concludes that all registrations for

domestic facilities are required to include the email addresses of a contact person of the facility. However, FDA recognizes that because of religious beliefs some registrants may disfavor the use of email communications between FDA and the facility in non-emergency situations, such as for routine communications, where the Agency can communicate with the facility by postal mail. We request comment on whether proposed § 1.232 should be modified to allow for registrants to request that the Agency only use email communications in emergency situations, such as during a terrorist attack, an outbreak of foodborne illness, or other food-related emergency.

5. Email Address for the U.S. Agent as Required Information

Section 415(a)(2) of the FD&C Act, as amended by section 102(a) of FSMA, requires, among other things, that a registration for a foreign facility contain the email address of the U.S. agent for the foreign facility. This requirement went into effect upon enactment of FSMA. Proposed § 1.232(c)(1) would require that a registration for a foreign facility include the email address of the foreign facility's U.S. agent in addition to the U.S. agent's name, full address, and phone number. Proposed § 1.232(c)(1) would therefore codify in FDA's registration regulation the requirement of section 415(a)(2) of the FD&C Act that a registration for a foreign facility contain the email address of the foreign facility's U.S. agent.

6. Assurance Statement That FDA Will Be Permitted To Inspect

Section 415(a)(2) of the FD&C Act, as amended by section 102(b) of FSMA, also requires, among other things, that food facility registrations contain an assurance that the Secretary (and by delegation, FDA) will be permitted to inspect such facility at the times and in the manner permitted by the FD&C Act. This requirement went into effect upon enactment of FSMA. Proposed § 1.232(a)(9) would codify such requirement in FDA's registration regulations. Specifically, proposed § 1.232(a)(9) would require a food facility registration to include a statement in which the owner, operator, or agent in charge provides an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act.

7. Consequences of Failing To Renew Registration

Currently, § 1.241 specifies the consequences of failing to register, update, or cancel a food facility registration. As described in current § 1.241(a), the failure of an owner, operator, or agent in charge of a food facility to register its facility, to update required elements of its facility's registration, or to cancel its registration in accordance with part 1, subpart H is a prohibited action under section 301(dd) of the FD&C Act. Accordingly, as further described in current § 1.241(a), the consequences of failing to register, update, or cancel a food facility registration include civil injunction proceedings under section 302 of the FD&C Act (21 U.S.C. 332), criminal penalties under section 303 of the FD&C Act (21 U.S.C. 333), and debarment of a person who has been convicted of a felony relating to importation of food into the United States under section 306 of the FD&C Act (21 U.S.C. 335a).

Proposed § 1.241(a) would amend current § 1.241(a) by adding the failure to renew a food facility registration among the list of actions related to food facility registration that could subject a person to the consequences specified in § 1.241(a). As discussed in section II, section 415(a)(3) of the FD&C Act, as amended by section 102(a) of FSMA, requires registrants to renew their facility registrations with FDA every other year. This requirement went into effect upon enactment of FSMA. Further, section 301(dd) of the FD&C Act provides that the failure to register in accordance with section 415 is a prohibited act. On June 2, 2014, FDA issued a guidance entitled “Compliance Policy Guide Sec. 100.250 Food Facility Registration—Human and Animal Food” stating that FDA will consider a registration to be expired if the registration is not renewed, as required by section 415(a)(3) of the FD&C Act, and the failure of a food facility to renew its registration with FDA, as required by section 415(a)(3) of the FD&C Act, means that the facility has failed to register in accordance with section 415 of the FD&C Act and thereby has committed a prohibited act under section 301(dd) of the FD&C Act (Ref. 1).

Accordingly, in addition to proposing to amend § 1.241(a), we are proposing to add proposed § 1.241(b) to specify that FDA will consider a registration for a food facility to be expired if the registration is not renewed, as required by § 1.230(b), and FDA will consider a food facility with an expired registration to have failed to register in accordance with section 415 of the FD&C Act. In addition, as discussed more fully in section III.B.10, under proposed § 1.241(c), FDA would cancel a registration that is expired for failure to renew if the facility has failed to renew its registration in accordance with proposed § 1.230(b).

B. Other Proposed Amendments to Registration of Food Facilities

1. U.S. Agent Information Sharing and Responsibilities

Section 415(a)(1)(B) of the FD&C Act provides in relevant part that the registration of a foreign food facility must include the name of the U.S. agent for the facility. Currently, § 1.227(b)(13) defines a U.S. agent, in relevant part, as a person (as defined in section 201(e) of the FD&C Act) residing or maintaining a place of business in the United States whom a foreign facility designates as its agent for purposes of food facility registration. In addition, § 1.227(b)(13)(i) currently provides that the U.S. agent acts as a communications link between FDA and the foreign facility for both routine and emergency situations and that FDA will contact the U.S. agent when an emergency occurs, unless the registration specifies another emergency contact (see also 68 FR 58894 at 58915). Further, § 1.227(b)(13)(ii) currently provides that FDA will treat representations by the U.S. agent as those of the foreign facility, and will consider information or documents provided to the U.S. agent the equivalent of providing the information or documents to the foreign facility.

Section 107 of FSMA amended the FD&C Act to provide U.S. agents with an additional role. Specifically, section 107 of FSMA added section 743(a)(1)(A) of the FD&C Act, which provides FDA with the authority to assess and collect fees from the U.S. agent for each foreign facility subject to reinspection to cover reinspection-related costs.

In order to further enable U.S. agents to serve their intended role, we are proposing to amend § 1.227(b)(13)(ii). Specifically, we are proposing to add that the U.S. agent of a foreign facility may view the information submitted in the foreign facility's registration. Making registration information available to U.S. agents would allow agents to obtain the most current information contained in FDA's registration database. U.S. agents could use such information to be in contact with foreign facilities, thereby enabling U.S. agents to more efficiently and effectively function as communications links between foreign food facilities and FDA. (See § 1.227(b)(13)(i) (establishing that a U.S. agent “acts as a communications link between FDA and the foreign facility for both emergency and routine communications”).) Further, U.S. agents could use such information to better represent foreign facilities when

communicating with FDA. (See § 1.227(b)(13)(ii) (specifying that FDA will treat representations by the U.S. agent as those of the foreign facility).) The proposal is also consistent with the status of information and documents provided to U.S. agents. Indeed, FDA's current regulations establish that “information or documents provided to the U.S. agent [are] the equivalent of providing the information or documents to the foreign facility.” (§ 1.227(b)(13)(ii).)

In proposing to make information submitted in a foreign facility's registration available to the U.S. agent for that facility, we have considered FDA's regulations governing public information (21 CFR part 20) among other factors. Section 20.21 (21 CFR 20.21) provides that any record of FDA that is disclosed in an authorized manner to any member of the public is available for disclosure to all members of the public (subject to certain exceptions). If U.S. agents had the same status as any member of the public, making registration information available to U.S. agents for review likely would constitute disclosure to the public and obligate FDA to make the same records available to any person who requests them under the Freedom of Information Act (FOIA). FDA tentatively concludes, however, that U.S. agents for foreign facilities do not have the same status as any member of the public within the context of registration for such facilities. Indeed, FDA's current registration regulations establish that U.S. agents function as stand-ins for foreign facilities with respect to communications and information sharing. Specifically, FDA's regulations establish that a U.S. agent “acts as a communications link between FDA and the foreign facility for both emergency and routine communications.” (§ 1.227(b)(13)(i).) Further, FDA's regulations establish that “information or documents provided to the U.S. agent [are] the equivalent of providing the information or documents to the foreign facility.” (§ 1.227(b)(13)(ii).) Put another way, making information or documents available to a U.S. agent has the same status as making information or documents available to a foreign facility. Thus, making registration information available for review to U.S. agents is the equivalent to making that information available for review to the U.S. agent's foreign facility. FDA tentatively concludes, therefore, that the requirement for uniform access in § 20.21 would not be triggered by FDA's proposed amendment to § 1.227(b)(13)(ii). FDA invites comments on this tentative conclusion.

For this same reason, FDA also tentatively concludes that making foreign facilities' registration information available to U.S. agents is consistent with the disclosure provision in section 415(a)(5) of the FD&C Act. That provision of the FD&C Act provides, in relevant part, that FDA's list of registered food facilities and registration documents submitted to FDA under section 415 shall not be subject to disclosure under FOIA. That provision also provides that information derived from such list shall not be subject to disclosure under FOIA to the extent that it discloses the identity or location of a specific registered person. Because § 1.227(b)(13)(ii) establishes that “information or documents provided to the U.S. agent [are] the equivalent of providing the information or documents to the foreign facility,” FDA's proposal to allow U.S. agents to view a foreign facility's registration information would not result in any disclosures. That is, allowing U.S. agents to view foreign facilities' registration information is the equivalent to allowing foreign facilities to view that information. Accordingly, FDA tentatively concludes that its proposal to amend § 1.227(b)(13)(ii) is consistent with the disclosure provision in section 415(a)(5) of the FD&C Act.

2. Verification Procedures for U.S. Agent

Proposed § 1.231(a)(5) and (b)(7) would provide that after a foreign facility completes its registration or updates its U.S. agent information as part of registration renewal, FDA will email the person identified as the U.S. agent for the foreign facility, using the email address for the person identified as the U.S. agent in the facility's registration, to verify that the person has agreed to serve as the facility's U.S. agent. FDA would not confirm the foreign facility's registration or registration renewal until that person confirms that the person agreed to serve as the U.S. agent for the foreign facility. In addition, with respect to initial registrations, FDA will not provide the facility with a registration number until that person confirms that the person agreed to serve as the U.S. agent for the foreign facility. Proposed § 1.231(a)(5) would apply this verification requirement to electronic registrations, and proposed § 1.231(b)(7) would apply this requirement to registrations submitted by mail or fax. Under proposed § 1.234(c)(2) and (d)(5), this verification step would also take place when foreign facilities update U.S. agent information. Those proposed provisions provide that when updating U.S. agent information, FDA will email the person identified as the U.S. agent for the foreign facility, using the email address for the person identified as the U.S. agent in the facility's registration, to verify that the person has agreed to serve as the U.S. agent. Under proposed § 1.234(c)(2) and (d)(5), FDA would not provide an update confirmation until that person confirms that the person agreed to serve as the U.S. agent for the foreign facility. Proposed § 1.234(c)(2) would apply this verification requirement to electronic updates, and proposed § 1.234(d)(5) would apply this requirement to updates submitted by mail or fax.

We are proposing this verification step for three reasons. First, we have learned that in some cases persons identified as U.S. agents in foreign food facility registrations were unaware that they had been so identified, and had not in fact agreed to serve as U.S. agents. Adding a verification step would help ensure that FDA's registration database is accurate and up to date. Second, the verification step would allow FDA to more efficiently enforce section 743 of the FD&C Act. As stated elsewhere in this proposed rule, section 743(a)(1)(A) of the FD&C Act authorizes FDA to assess and collect fees from the U.S. agent for each foreign facility subject to reinspection to cover reinspection-related costs. Verifying that individuals identified as U.S. agents in foreign facilities' registrations have actually agreed to serve as U.S. agents for those facilities would help ensure that FDA is assessing and collecting foreign facility reinspection fees from the appropriate individuals and allow for efficient enforcement of section 743 of the FD&C Act. Third, section 305(d) of the Bioterrorism Act (Pub. L. 107-188) directs FDA, in relevant part, to ensure adequate authentication protocols are used to enable identification of the registrant and validation of the registration data, as appropriate, for registrations submitted to FDA electronically. FDA tentatively concludes that a verification step for U.S. agent information would serve as an authentication protocol and help validate registration data concerning U.S. agents, including in those registrations submitted electronically.

We seek comments on these proposed provisions, including on whether the proposed email verification step will be effective in preventing the unauthorized listing of persons as U.S. agents. Further, we seek comment on the effectiveness of this proposed email verification step in connection with two

other ideas about which we request comment elsewhere in this document: The idea for a U.S. Agent Voluntary Identification System discussed in section III.C., and the idea to require Data Universal Numbering System (D-U-N-S®) numbers for U.S. agents discussed in section III.B.3. We also seek comments on what alternative approaches, if any, FDA should take to prevent unauthorized U.S. agent listings.

3. Proposed Requirement for D-U-N-S® Number and Verification Procedures

Proposed § 1.232(a)(2) would require the D-U-N-S® number of a domestic and foreign facility be included in the facility's registration. This requirement would function in connection with proposed § 1.231(a)(3) and (b)(5), which provide that after a facility completes its registration or updates its D-U-N-S® number as part of registration renewal, FDA will verify the accuracy of the food facility's D-U-N-S® number and will also verify that the facility-specific address associated with the D-U-N-S® number is the same address associated with the facility's registration. Under proposed § 1.231(a)(3) and (b)(5), FDA would not confirm a food facility's registration or registration renewal until FDA verifies the accuracy of its D-U-N-S® number and verifies that the facility-specific address associated with the D-U-N-S® number is the same address associated with the facility's registration. With respect to initial registrations, proposed § 1.231(a)(3) and (b)(5) would also provide that FDA would not provide a facility with a registration number until FDA verifies the accuracy of its D-U-N-S® number and verifies that the facility-specific address associated with the D-U-N-S® number is the same address associated with the facility's registration. Proposed § 1.231(a)(3) would apply this verification requirement to electronic registrations, and proposed § 1.231(b)(5) would apply this requirement to registrations submitted by mail or fax. The requirement to submit D-U-N-S® numbers would also function in connection with proposed § 1.234(c)(2) and (d)(5), which provide that FDA will perform the same verification step after facilities complete their registration updates. Under proposed § 1.234(c)(2) and (d)(5), FDA would not provide an update confirmation until FDA verifies the accuracy of the food facility's D-U-N-S® number and also verifies that the facility-specific address associated with the D-U-N-S® number is the same address associated with the facility's registration. Proposed § 1.234(c)(2) would apply this verification requirement to electronic updates, and proposed § 1.234(d)(5) would apply this requirement to updates submitted by mail or fax.

Dun & Bradstreet assigns and maintains a database of the D-U-N-S® numbers, which serve as unique identifiers (codes) of business entities. A D-U-N-S® number is a unique nine-digit sequence provided by Dun & Bradstreet that can be specific for each site. The site-specific number is a widely recognized business identification tool and serves as a useful resource for FDA in identifying and verifying certain business information submitted by a user. Upon application, each physical location of a business entity may be assigned a distinct site-specific nine-digit D-U-N-S® number. D-U-N-S® Numbers are proprietary to and controlled by Dun & Bradstreet (D&B).

If a food facility has not obtained a D-U-N-S® number, it may obtain one for no cost directly from Dun & Bradstreet (
http://www.dnb.com
). If a registrant does not include a D-U-N-S® number for its facility in a registration, FDA intends to make arrangements for obtaining a D-U-N-S® number for the facility by providing a direct link to Dun and Bradstreet in the registration system. FDA intends to allow a registrant attempting to register a facility without a D-U-N-S® number to temporarily save its registration information in the registration system and return to the registration system to complete its registration once the required D-U-N-S® number is obtained. Having registration information saved in the registration system, however, would not be equivalent to completing a registration. As discussed previously, under proposed § 1.231(a)(3) and (b)(5), FDA would not confirm a food facility's registration or registration renewal until FDA verifies the accuracy of its D-U-N-S® number and verifies that the facility-specific address associated with the D-U-N-S® number is the same address associated with the facility's registration.

FDA's tentative decision to require and verify D-U-N-S® numbers is grounded in the statutory objective of efficiently enforcing the food safety and other requirements of the FD&C Act. By requiring D-U-N-S® numbers of facilities, FDA would be able to verify the facility-specific address information associated with those numbers. Such verification would increase the accuracy of FDA's food facility registration database. As a consequence, FDA investigators would have access to more accurate food facility information, and would therefore be able to more efficiently identify and locate food facilities for inspection. As a result, FDA would be able to more efficiently conduct inspections under section 704 to enforce the food safety and other requirements of the FD&C Act.

FDA's tentative decision to require D-U-N-S® numbers in food facility registration is also consistent with FDA's mandate under section 415(a)(5) of the FD&C Act to compile and maintain an up-to-date list of registered food facilities, as well as the requirement in section 415(a)(2) of the FD&C Act that registrants submit information necessary to notify FDA of the name and address of each facility at which the registrant conducts business. Indeed, the verification that D-U-N-S® numbers provides would help ensure that the food facility list is up to date and contains accurate information concerning the addresses of food facilities. Moreover, an up-to-date list that includes information necessary to notify FDA of the name and address of food facilities would aid FDA in efficiently responding to a terrorist threat or other food-related emergency. Finally, FDA's tentative decision to require D-U-N-S® numbers is consistent with the direction contained in section 305(d) of the Bioterrorism Act (Pub. L. 107-188) to ensure adequate authentication protocols to enable identification of the registrant and validation of the registration data for registrations submitted to FDA electronically. FDA tentatively concludes that verifying information in connection with a D-U-N-S® number for a food facility would provide FDA with a protocol to enable FDA to identify food facilities and verify certain registration information for those facilities. We are seeking comment on these proposed provisions.

In addition to requesting comment on the proposals related to requiring facility-specific D-U-N-S® numbers, we request comment on whether FDA should require use of a different facility identifier and, if so, what that identifier should be. If you recommend that FDA use a different identifier, we request comment on whether FDA should verify that identifier and whether FDA should verify facility-specific address information in connection with that identifier. We also request comment on whether FDA should also require that the registrations of foreign facilities also include a D-U-N-S® number or other identifier for the facility's U.S. agent. To the extent FDA does pursue a D-U-N-S® number requirement, we seek comment on whether, as with the D-U-N-S® number for food facilities, FDA

should verify the accuracy of the U.S. agent D-U-N-S® numbers and whether FDA should verify that the contact information associated with the D-U-N-S® numbers is the same contact information submitted as part of the foreign food facilities' registrations. In addition, we request comment on whether FDA should perform such verification after a facility completes or updates its registration, and whether FDA should verify this information prior to confirming a food facility's registration, prior to confirming a registration renewal, prior to providing an update confirmation, and prior to providing the facility with a registration number when the facility first registers. If you recommend that FDA require that registrations of foreign facilities include an identifier other than a D-U-N-S® number for their U.S. agents, we request comment on whether FDA should verify that identifier and whether FDA should verify contact information in connection with that identifier.

We are requesting comment related to requiring D-U-N-S® numbers and other identifiers for U.S. agents because FDA has encountered instances in which foreign food facilities have included invalid U.S. agent information in their registrations. We are considering whether to require D-U-N-S® numbers or other identifiers for U.S. agents and verify the information associated with such numbers in order to increase the accuracy and reliability of the U.S. agent information. We also believe that more accurate U.S. agent information would allow FDA to more efficiently enforce section 743 of the FD&C Act, which authorizes FDA to assess and collect fees from the U.S. agent for each foreign facility subject to reinspection to cover reinspection-related costs. In addition, and as noted elsewhere in this proposed rule, section 305(d) of the Bioterrorism Act (Pub. L. 107-188) directs FDA, in relevant part, to ensure adequate authentication protocols are used to enable identification of the registrant and validation of the registration data, as appropriate, for registrations submitted to FDA electronically. FDA believes that requiring D-U-N-S® numbers or other identifiers and verifying information associated with such numbers could serve as an authentication protocol and help validate registration data concerning U.S. agents, including in those registrations submitted electronically. We seek comment on whether the D-U-N-S® numbers or other identifiers for U.S. agents and verification of such numbers and related information would, in fact, increase the accuracy and reliability of the U.S. agent information. We also seek comment on any burdens that requiring D-U-N-S® numbers or other identifiers for U.S. agents would entail, both for foreign facilities and any persons registered as U.S. agents.

4. Proposed Requirement for Email Address of Owner, Operator or Agent in Charge Who Authorized a Third Party To Act on Behalf of the Facility and Verification Procedure

The only individuals permitted to register a facility are the owner, operator, or the agent in charge of the facility or an individual authorized to register the facility on behalf of the owner, operator, or agent in charge. (Section 415(a)(1) of the FD&C Act; §§ 1.225 and 1.232 (21 CFR 1.225 and 1.232).) Currently, § 1.232(i) provides that if the individual submitting the registration form is not the owner, operator, or agent in charge of the facility, the registration must include a statement in which the individual certifies that the information submitted is true and accurate, certifies that he/she is authorized to submit the registration, and identifies by name, address, and telephone number, the individual who authorized submission of the registration. We are proposing to recodify this provision at § 1.232(a)(10), and also to add the email address of the individual who authorized submission of the registration to the list of required information identifying the individual who authorized submission of such registrations. Proposed § 1.230(b) would apply this requirement to registration renewals. Thus, for registrations and registration renewals submitted by an individual who is not the owner, operator, or agent in charge, such submissions would be required to include a statement in which the individual certifies that the information submitted is true and accurate, certifies that he/she is authorized to submit the registration, and identifies by name, address, email address, and telephone number, the individual who authorized submission of the registration. In addition, proposed § 1.234(a) would provide that updates not submitted by the owner, operator, or agent in charge of the facility must include the email address of the owner, operator, or agent in charge who authorized submission of the update, and proposed § 1.235(b)(5) would provide this same email address requirement for cancellations not submitted by the owner, operator, or agent in charge of the facility.

These requirements would function in connection with proposed §§ 1.231(a)(4) and (b)(6), 1.234(c)(3) and (d)(6), and 1.235(c)(3) and (d)(6), which provide a verification step for electronic registrations and registration renewals, mail/fax registrations and registration renewals, electronic updates, mail/fax updates, electronic cancellations, and mail/fax cancellations not submitted by the owner, operator or agent in charge of the facility. Specifically, these proposals provide that after completion of such submissions, FDA will email the individual identified as the owner, operator, or agent in charge who authorized the submission to verify that the individual in fact authorized the submission on behalf of the facility. Under proposed § 1.231(a)(4) and (b)(6), FDA would not confirm the registration or provide a registration number until that individual confirms that he or she authorized the registration. With respect to registration renewals, proposed § 1.231(a)(4) and (b)(6) provide that FDA would not provide a confirmation of the registration renewal until the individual confirms that he or she authorized the registration renewal. Under proposed § 1.234(c)(3) and (d)(6), FDA would not confirm a registration update until the individual identified as the owner, operator, or agent in charge who authorized the update confirms that he or she in fact authorized the update on behalf of the facility. And under proposed § 1.235(c)(3) and (d)(6), FDA would not confirm a registration cancellation until the individual identified as the owner, operator, or agent in charge who authorized the update confirms that he or she in fact authorized the cancellation on behalf of the facility. Proposed § 1.231(a)(4) would apply this verification requirement to electronic registrations and registration renewals; proposed § 1.231(b)(6) would apply the verification requirement to registration and registration renewals submitted by mail or fax; proposed § 1.234(c)(3) would apply the verification requirement to electronic updates; proposed § 1.234(d)(6) would apply the verification requirement to updates submitted by mail or fax; proposed § 1.235(c)(3) would apply the verification requirement to electronic cancellations; and proposed § 1.235(d)(6) would apply the verification requirement to cancellations submitted by mail or fax.

We are proposing this email requirement and verification step to address a problem with unauthorized third party registration submissions that FDA has encountered in the course of implementing food facility registration. In some cases, this has resulted in duplicate registrations for foreign food facilities. In other cases, registrations

have been created for facilities that do not in fact manufacture/process, pack, or hold food for consumption in the United States. Unauthorized third party registrations threaten the accuracy of FDA's food facility registration database, resulting in false entries that make it more difficult for the Agency to use its database to respond to food-related emergencies, as well as to identify food facilities for inspection. Such registrations also create potential problems for the facilities that are the subject of the unauthorized registrations. We tentatively conclude that the proposed email address and verification requirements are necessary to ensure the accuracy and truthfulness of food facility registrations. By requiring the email address of the owner, operator, or agent who authorizes third party registration submissions and using that email address to conduct a verification step, we believe that we would incentivize authorized, truthful registration submissions. As such, we tentatively conclude that these proposals would assist FDA in efficiently meeting its statutory obligation under section 415(a)(5) of the FD&C Act to compile and maintain an up-to-date list of food facilities. We further tentatively conclude that these proposals would help in ensuring compliance with section 415(a)(1) of the FD&C Act. Under section 415(a)(1) of the FD&C Act and §§ 1.225 and 1.232, the only individuals permitted to register a facility are the owner, operator, or agent in charge of the facility or an individual authorized to register the facility on behalf of the owner, operator, or agent in charge. Registrations submitted by non-authorized individuals would not be in compliance with those provisions. In addition, we tentatively conclude that the proposed email address and verification step requirements would assist FDA in achieving the key objectives of food facility registration. Those objectives include using the registration database to prevent and respond to food-related emergencies, and meeting them requires an accurate and up-to-date list of registered facilities. Finally, we tentatively conclude that the proposals are consistent with section 305(d) of the Bioterrorism Act (Pub. L. 107-188), which directs FDA, in relevant part, to ensure adequate authentication protocols are used to enable identification of the registrant and validation of the registration data, as appropriate, for registrations submitted to FDA electronically. FDA tentatively concludes that the proposed verification step for registration submissions made by individuals other than the owner, operator, or agent in charge would serve as an authentication protocol and help validate registration data.

We seek comment on these proposed provisions, including on whether the proposed email verification step will be effective in preventing the unauthorized submission of registrations, registration renewals, updates, and cancellations. We also seek comment on whether we should require any alternative or additional checks to ensure that the individual registering a facility is authorized to do so by the owner, operator, and agent in charge. For instance, should FDA require that owners, operators, or agents in charge create some type of authorization documentation to provide documentation for the fact that the owner, operator or agent in charge has authorized the individual to make a registration submission? If so, should such documentation be required to be submitted to FDA or maintained at the facility? Should such documentation include a letter signed by the owner, operator, or agent in charge authorizing the individual to make a registration submission? Are there other types of documentation that would provide another check that is necessary to ensure that the owner, operator, or agent in charge in fact provided authorization?

5. Proposal To Require Certain Information in Food Facility Registration That Is Currently Optional

a. Preferred mailing address information.
Proposed § 1.232(a)(3) would require that domestic and foreign food facilities provide a preferred mailing address if such mailing address is different from the mailing address of the facility. We are proposing to require this information because we need to be able to efficiently contact food facilities with information regarding potential food-related emergencies and, when applicable, information regarding a suspension of a food facility's registration. If food facilities provide preferred mailing addresses that are different from the mailing address of a food facility, FDA would be able to more efficiently contact food facilities and share such information. Proposed § 1.232(a)(3) would therefore assist FDA in efficiently enforcing section 415 of the FD&C Act. We are seeking comments on this proposed provision.

b. Email address for the owner, operator or agent in charge of the facility.
Currently § 1.232(c) requires a food facility registration to include the name, address, and phone number of the owner, operator, or agent in charge of domestic and foreign facilities, but does not require that individual's email address. Proposed § 1.232(a)(6) would add email address to the contact information required for the owner, operator, or agent in charge of the facility (for both domestic and foreign facilities). Although the FSMA amendments provide that registrations for domestic food facilities are now required to contain the email address for the contact person of the facility, often the contact person for the facility is not the same as the owner, operator, or agent in charge of the facility. We are proposing to require email addresses for the owner, operator, or agent in charge of food facilities in order to facilitate quick communications with those individuals. Such communications may be necessary in the event of food-related emergencies and, where applicable, suspensions of a food facility's registration. Accordingly, we tentatively conclude that such information is necessary for FDA's efficient enforcement of section 415 of the FD&C Act.

We are proposing this requirement in addition to the requirements in §§ 1.232(a)(10), 1.230(b), 1.234(a), and 1.235(b)(5) discussed earlier in this document with respect to registrations, registration renewals, updates, and cancellations submitted by individuals other than the owner, operator, or agent in charge of the facility. For such submissions, we are proposing in §§ 1.232(a)(10), 1.230(b), 1.234(a), and 1.235(b)(5) to require the email address of the owner, operator, or agent in charge who authorized such submissions. We realize that in some cases the owner, operator, or agent in charge email address in proposed § 1.232(a)(6) may be the same email address as the email address for the owner, operator, or agent in charge who authorized third party registration submissions in proposed §§ 1.232(a)(10), 1.230(b), 1.234(a), and 1.235(b)(5). In some cases, however, the email addresses might differ.

We are seeking comments on this proposed provision. Further, we are seeking comments on whether a waiver for this proposed requirement should be available in limited circumstances such as when and if the religious beliefs of an owner, operator or agent in charge prevent that individual from obtaining an email address. We are also seeking comments on how a food facility should request such a waiver, including whether such waivers should be requested in writing.

c. Type of activity conducted at the facility.
Proposed § 1.232(a)(8) would

require the type of activity conducted at the facility for each food product category identified. In addition, proposed § 1.232(a)(8) would require facilities to choose among the following activity types: (1) Ambient human food storage warehouse/holding facility; (2) Refrigerated human food warehouse/holding facility; (3) Frozen human food warehouse/holding facility; (4) Interstate conveyance caterer/catering point; (5) Contract Sterilizer; (6) Labeler/Relabeler; (7) Manufacturer/Processor; (8) Farm Mixed-Type Facility; (9) Packer/Repacker; (10) Salvage Operator (Reconditioner); (11) Animal food warehouse/holding facility; and (12) Other Activity. Facilities would be permitted to select more than one activity type for each food product category identified. The “Other Activity” option would only be available if the facility engages in an activity that is not covered by the other options. Facilities that select “Other Activity” would be required to enter text onto the food facility registration form describing the activity.

FDA believes that information regarding activity type is necessary to assist the Agency in using its limited resources efficiently, including with regard to inspectional oversight. Among other purposes, food facility registration was designed to provide FDA with a complete list of foreign and domestic facilities that manufacture/process, pack, or hold food for consumption into the United States. In the approximately 10 years since food facility registration was originally implemented, the list of facilities has helped FDA accomplish one of its most important regulatory activities: Scheduling and planning inspections of establishments in which foods are manufactured/processed, packed, or held under section 704 of the FD&C Act. Specifically, FDA has used the food facility registration list to identify food facilities for inspection.

Although the creation of food facility registration has led to improvements in FDA's ability to identify food facilities for inspection, the limited nature of the information provided through food facility registration has meant that the information has not functioned as the most efficient tool for planning inspections. For instance, registrants have not been required to provide the Agency with such basic information as whether a facility manufactures/processes or holds foods, or both. The difference between manufacturing/processing and holding is important. FDA might prepare for inspections of manufacturing/processing and holding facilities quite differently, and might assign different personnel for the different types of inspections. With information about activity type, however, the Agency would be better able to prepare investigators for inspections and assign appropriate investigators. This would provide for more efficient use of the Agency's limited inspectional resources, as sending appropriate, well-prepared investigators helps ensure that inspections are thorough and meaningful. Requiring information regarding activity type would therefore allow for the more efficient use of FDA's inspectional authority under section 704.

The activity type requirement would serve additional purposes as well. Information about a facility's activity type would provide FDA with important information regarding a facility's role in the U.S. food supply system. This would allow FDA to better assess the facility's potential impact in cases of bioterrorist incidents or other food-related emergencies. Better information about a facility's impact would assist FDA in using its limited resources efficiently during such incidents, for instance helping the Agency identify manufacturers/processors that may receive contaminated ingredients or frozen storage facilities impacted by power outages. The improved information would also allow FDA to communicate more quickly and efficiently on various non-emergency issues, such as new regulatory requirements or policies.

In addition, the activity type information would aid FDA in implementing FSMA's mandate to determine inspectional frequency based on safety risks. Specifically, section 201(a) of FSMA created section 421 of the FD&C Act, which requires the Agency to identify high-risk facilities and mandates more frequent inspections for domestic high-risk facilities than for domestic non-high-risk facilities. For the purposes of section 421, the term “facility” refers to facilities that are required to register under section 415. (See section 421(e).) Section 421(a)(1) sets forth the factors for FDA to use in identifying high-risk facilities, which include “[a]ny . . . criteria deemed necessary and appropriate by the Secretary for purposes of allocating inspection resources.” (Section 421(a)(1)(F).) Among the criteria the Agency has deemed necessary and appropriate for this purpose are type of activity conducted at the facility (manufacturer/processor, packer/repacker, etc.). Because section 421's risk-based inspection mandate applies to facilities registered under section 415, and because the Agency has identified information about the type of activity conducted at a facility as an important factor to consider when identifying high-risk facilities under section 421, FDA tentatively concludes that the proposed activity type requirement for registration would allow the Agency to more efficiently enforce section 421.

For all of these reasons, FDA tentatively concludes that section 415 of the FD&C Act, along with sections 421, 701(a), and 704, authorize FDA to require the submission of the activity type information specified in this proposed rulemaking.

Although proposed § 1.232(a)(8) lists the specific activity types that food facilities must select, the proposed provision does not define those activity types. FDA is requesting comments on whether it should define the specified activity types in FDA's food facility registration regulations. To the extent that FDA does define the activity types, FDA anticipates that the Agency would model the activity type definitions from the definitions for establishment types contained in the Agency's Field Management Directive (Ref. 2), while also modifying the Field Management Directive definitions to reflect the nature of activities conducted by registered food facilities and the information required on other parts of the food facility registration form. FDA tentatively concludes that modeling the activity type definitions from the Field Management Directive definitions would allow for the efficient use of FDA inspectional resources. FDA investigators are already familiar with the Field Management Directive, and consistency between the food facility registration and Field Management Directive definitions would minimize confusion about the nature of activities performed at food facilities. FDA's tentative definitions for food facility activity types for food facilities that are required to register under section 415 of the FD&C Act are as follows:

• Ambient human food storage warehouse/holding facility: A facility that holds or stores food for human consumption at ambient air temperatures (approximately 21 °C/70 °F). Examples include storage tanks and grain elevators.

• Refrigerated human food warehouse/holding facility: A facility that holds or stores food products for human consumption at refrigerated temperatures (approximately 4 °C/40 °F-0 °C/32 °F).

• Frozen human food warehouse/holding facility: A facility that holds or stores food for human consumption at frozen temperatures (approximately0 °C/32 °F or below).

• Interstate conveyance caterer/catering point: A facility that prepares complete or partial meals or drinks from raw or partially processed materials for service to passengers or crew aboard an interstate conveyance or for consumption by these groups at a location other than where prepared.

• Contract Sterilizer: A facility that performs sterilization or irradiation of foods or components of foods.

• Labeler/Relabeler: A facility that affixes the original labeling to a food product or changes in any way the labeling on a food product without affecting the product or its container.

• Manufacturer/Processor: A non-farm facility that makes food from one or more ingredients, or synthesizes, prepares, treats, modifies, or manipulates food, including food crops or ingredients. For purposes of this activity type option, examples of manufacturing/processing activities are cutting, peeling, trimming, washing, waxing, eviscerating, rendering, cooking, baking, freezing, cooling, pasteurizing, homogenizing, mixing, formulating, bottling, milling, grinding, extracting juice, distilling, or packaging.

• Farm Mixed-Type Facility: An establishment that grows and harvests crops or raises animals and may conduct other activities within the farm definition in § 1.227, but also conducts activities that require the establishment to be registered.

• Packer/Repacker: A facility that packs a food product or products into different containers without making any change in the form of the product.

• Salvage Operator (Reconditioner): A facility that deals in the resale and reconditioning of damaged foods.

• Animal food warehouse/holding facility (
e.g.,
storage facilities, including storage tanks, grain elevators): A facility that holds or stores food for animal consumption at any temperature.

FDA requests comment on whether the above definitions provide sufficient information for food facilities to select from the activity type options. To the extent that the definitions do not provide sufficient information, FDA requests comment on how the activity type definitions should be amended. In addition to seeking comment on whether and how to define the above activity types, FDA seeks comment on whether the activity types listed in proposed § 1.232(a)(8) encompass the full range of activities conducted by registered food facilities and whether they are otherwise appropriate. FDA selected the list of activity types in proposed § 1.232(a)(8) because that list largely reflects the optional activity types on current Form FDA 3537. At the same time, we are proposing several modifications to the current optional list of activity types. The modifications are designed to help FDA communicate more quickly with food facilities in the case of food-related emergencies, as well as to more accurately reflect the types of activities conducted at human and animal food facilities. Such modifications include dividing the optional activity type of “warehouse/holding facility” for facilities that hold food for human consumption into three subcategories. Those three subcategories would be “ambient human food temperature warehouse/holding facility,” “refrigerated human food warehouse/holding facility,” and “frozen human food warehouse/holding facility.” These additional subcategories would enable FDA to more quickly alert facilities potentially affected by an emergency food incident if FDA receives information indicating the type of facility affected. For example, if FDA receives information indicating that refrigerated or frozen warehouses/holding facilities could be affected by power outages, FDA would be able to communicate with such facilities about the incident. For animal food warehouse/holding facilities, however, FDA is not proposing to modify the activity types (that are currently optional) on current Form FDA 3537. FDA has tentatively concluded that the nature of animal food warehouse/holding facilities differs from human food warehouse/holding facilities, and that the current list of activity types—which has only one option for warehouse/holding—sufficiently enables FDA to respond quickly in the case of emergencies related to animal food. Indeed, animal food warehouse/holding facilities typically hold or store animal food at ambient temperature, negating the need for FDA to have information about the temperature storage conditions at animal food facilities.

In addition, FDA is proposing to add a “farm mixed-type facility” activity type option. FDA is proposing to add this activity type option in order to help the Agency efficiently inspect farm mixed-type facilities. The expertise required to inspect such facilities may differ from the expertise required to inspect non-farm manufacturing/processing facilities. Information about whether a facility is a farm mixed-type facility would therefore allow FDA to identify appropriate investigators to conduct such inspections.

Another change FDA is proposing to make from the optional activity types on current Form FDA 3537 is to eliminate the “commissary” activity type option. FDA is proposing this change because the Agency has tentatively concluded that the other activity type options listed in proposed § 1.232(a)(8)(i) through (a)(8)(xi) sufficiently address the types of activities conducted by facilities that identify as commissaries and that are required to register under section 415 of the FD&C Act.

Finally, FDA seeks comment on whether low-acid and acidified food processing should be treated as activity types, or whether there should be food product category options related to low-acid canned foods and acidified foods, or both. Currently, low-acid food and acidified food processing are optional activity types on current Form FDA 3537. In addition, FDA identified low-acid canned food products and acidified foods as food product categories in the October 2012 guidance the Agency issued concerning food product categories. (See “Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories.”) As a result of the October 2012 guidance, low-acid foods and acidified foods have been listed on Form FDA 3537 as food product categories, while also being included as optional activity types. FDA recognizes that it may be confusing and redundant for there to be both food product categories and activity type categories related to low-acid canned foods and acidified foods. FDA also recognizes that the food product categories for low-acid canned foods and acidified foods may be broad in certain circumstances and may encompass a number of foods for which there may also be other applicable food categories. For example, a low-acid food might also be a baby food, which is another food product category option. And an acidified food might also be a fruit or fruit product, which is also another food product category option. A facility that manufactures/processes, packs, or holds low-acid food that is a baby food or an acidified food that is fruit or fruit product might therefore be confused about which food product categories to select. Accordingly, FDA seeks comment on whether low-acid and acidified foods should be included in only one portion of Form FDA 3537. We further seek comment on whether to include these products in the activity type section or the food product category section of Form FDA 3537. We also seek comment on all aspects of our proposal related to requiring food facilities to identify the type of activity conducted at the facility for each food product category identified.

d. Email address of the emergency contact of a domestic facility.
Proposed

§ 1.232(b)(2) would add an email address to the emergency contact information registrants are required to provide for a domestic facility. Thus, in addition to the emergency contact phone number required under current § 1.232(e), registrants would also be required to provide an emergency contact email address. This proposed change would not affect the role of the emergency contact information. The emergency contact information would continue to be used in the event that we need to correspond with the facility during a terrorist threat or other food-related emergency. The purpose of requiring an email address is that such information would provide an efficient method of reaching the emergency contact in addition to the already required emergency contact phone number. We realize that in some cases the emergency contact email address may be the same email address as the email address for the facility contact person required in proposed § 1.232(b)(1) for domestic facilities. Consequently, proposed § 1.232(b)(2) would require an emergency contact email address to be provided only if that email address is different from the facility contact person email address required in proposed § 1.232(b)(1). Accordingly, the email address for the facility contact person required in proposed § 1.232(b)(1) would serve as the default emergency contact email address unless a facility provides a different emergency contact email address. We are seeking comments on this proposed provision.

6. Proposal To Identify and Update Food Product Categories

Proposed § 1.232(a)(7) would retain the requirement in current § 1.232(g) that food facilities provide information regarding food product categories, but would change that requirement to be consistent with the changes FDA has made to food product categories in response to the FSMA amendments.

Section 415(a)(2) of the FD&C Act, as added by section 305 of the Bioterrorism Act, provided in relevant part that, when determined necessary by FDA “through guidance,” a registrant must submit a registration to FDA containing information necessary to notify FDA of the general food category (as identified in § 170.3) of food manufactured, processed, packed, or held at such facility. On July 17, 2003, FDA issued a guidance document stating that FDA had determined that the inclusion of food product categories in food facility registrations was necessary for a quick, accurate, and focused response to an actual or potential bioterrorist incident or other food-related emergency (see 68 FR 42415). On October 10, 2003, FDA issued an interim final rule that also required facilities to submit registrations to FDA containing information regarding applicable food product categories as identified in § 170.3. Specifically, current § 1.232(g) provides that food facility registrations include applicable food product categories as defined in § 170.3, unless facilities check either “most/all human food product categories,” according to § 1.233(j), or “none of the above mandatory categories” because a facility manufactures/processes, packs, or holds a food that is not identified in § 170.3. On October 3, 2005, FDA issued a final rule for food facility registration, which generally confirmed the interim final rule (70 FR 57505).

As discussed previously, section 102 of FSMA amends section 415(a)(2) of the FD&C Act, to now provide, in relevant part, that, when determined necessary by FDA “through guidance,” a registrant is required to submit a registration to FDA containing information necessary to notify FDA of the general food category (as identified in § 170.3 or any other food categories, as determined appropriate by FDA, including by guidance) of any food manufactured, processed, packed, or held at such facility. In October 2012, FDA issued a guidance document entitled “Guidance for Industry: Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories” (Ref. 3). This guidance document represents FDA's conclusion on the necessity of food product categories in food facility registrations and identifies additional food product categories, as provided by section 415(a)(2) of the FD&C Act. In the guidance document, FDA explained that because of Congress's explicit statutory authorization to effectuate a binding requirement based on findings in a guidance, the document is not subject to the usual restrictions in FDA's good guidance practice (GGP) regulations, such as the requirements that guidances not establish legally enforceable responsibilities and that they prominently display a statement of the document's nonbinding effect (21 CFR 10.115(d) and (i)).

Proposed § 1.232(a)(7) would be consistent with FDA's October 2012 guidance and the FSMA amendments. Specifically, the proposed provision would require that a food facility registration include applicable food product categories of any food manufactured/processed, packed, or held at the facility, as identified on Form FDA 3537. FDA intends to address any further amendments of the food product categories contained on FDA Form 3537, if necessary and appropriate, through updates to the guidance document “Guidance for Industry: Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories.” We are seeking comments on this proposed provision.

7. Proposal To Remove List of Optional Items Included in the Registration

Proposed § 1.233 would provide that FDA encourages, but does not require, registrants to submit items that are indicated as optional on the Form FDA 3537. This proposed amendment would remove the list of optional items currently codified in § 1.233. We are proposing this change for two reasons. First, we are proposing elsewhere in this document to convert several of the optional items in current § 1.233 into required items in proposed § 1.232. Second, we believe FDA recommendations for optional items to include in food facility registrations are better addressed in guidance documents that follow our GGP regulations in 21 CFR 10.115. We are seeking comments on this proposed amendment.

8. Proposal To Require Immediate Updates to Incorrect Registration Information

Proposed § 1.231(a)(6) would require a food facility to immediately update any previously submitted registration information that was incorrect at the time of submission of an electronic registration or registration renewal. This proposal is consistent with the current requirement in § 1.231(b)(6) for registrations submitted by mail or fax, as well as with the current requirement in § 1.231(c)(10) for registrations submitted by CD-ROM. Under current § 1.231(b)(6) and (c)(10), any information that was incorrect at the time of submission of a registration submitted by mail or fax or CD-ROM must be immediately updated. Under the proposed rule, § 1.231(b)(6) would be recodified as § 1.231(b)(9). (Current § 1.231(c)(10) would not be recodified, as FDA is proposing to no longer allow registration submissions to be submitted by CD-ROM.) That requirement would also apply to registration renewals submitted by mail or fax, as we are proposing for all of the requirements in § 1.231(b) to apply to both registrations and registration renewals submitted by mail or fax.

We are proposing to require the immediate update of incorrect information submitted in electronic

registrations and registration renewals so that the requirement to immediately update incorrect information applies equally to registration submissions that are made electronically and by mail or fax. When FDA first implemented food facility registration in 2003, the Agency was concerned that a requirement for immediate updates of electronically submitted incorrect information would burden the food facility registration data system. Now, however, we have no such concerns. Due to advances in technology, we are confident in the ability of our data systems to maintain functionality while frequent updates are made in the system. Additionally, the majority of registrants now submit their registrations electronically, and FDA is proposing to require electronic registration beginning in 2016. With so many electronic registrations, the accuracy of the registration database depends on food facilities providing correct information. We tentatively conclude that the requirement for immediate updates of incorrect information submitted in electronic registrations and registration renewals would help ensure that FDA's registration database is accurate and up to date. Such an outcome would be consistent with FDA's mandate under section 415(a)(5) of the FD&C Act to compile and maintain an up-to-date list of food facilities. It would also be consistent with the requirement in section 415(a)(2) of the FD&C Act that registrants notify FDA “in a timely manner” of changes to the registration information they submit under that provision. Importantly, a more accurate and up-to-date registration database would help FDA more efficiently and effectively prevent and respond to food-related emergencies. To the extent that any incorrect information is relevant to FDA in planning for inspections, the proposed requirement would also aid the Agency in more efficiently and effectively locating and identifying food facilities for inspection. We reques

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2015-08018. Public record. Not legal advice.