Document ID: FDA-2013-N-0590-0001
Agency: fda
Document Type: Proposed Rule
Title: Implementation of the Food and Drug Administration Food Safety
Modernization Act Amendments to the Reportable Food Registry Provisions of the Federal Food, Drug, and Cosmetic Act
Posted Date: 2014-03-26T04:00Z

[Federal Register Volume 79, Number 58 (Wednesday, March 26, 2014)]
[Proposed Rules]
[Pages 16698-16704]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-06614]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Chapter I

[Docket No. FDA-2013-N-0590]
RIN 0910-AG97

Implementation of the Food and Drug Administration Food Safety 
Modernization Act Amendments to the Reportable Food Registry Provisions 
of the Federal Food, Drug, and Cosmetic Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Advance notice of proposed rulemaking.

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SUMMARY: The Food and Drug Administration (FDA) is issuing this advance 
notice of proposed rulemaking (ANPRM) to solicit comments, data, and 
information to assist the Agency in implementing the FDA Food Safety 
Modernization Act (FSMA), which added new provisions to the Reportable 
Food Registry (RFR) requirements of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act). Under the new provisions, FDA may require 
a responsible party to also submit to FDA ``consumer-oriented'' 
information regarding certain reportable foods, including information 
necessary to enable a consumer to accurately identify whether the 
consumer is in possession of a reportable food. FDA must prepare and 
publish on FDA's Internet Web site a one-page summary of the consumer-
oriented information that can be easily printed by a grocery store for 
the purposes of consumer notification. A grocery store that sold a 
reportable food that is the subject of an FDA one-page summary, and 
that is part of a chain of establishments with 15 or more physical 
locations, is required to prominently display the FDA one-page summary, 
or the information from the summary, within 24 hours after the one-page 
summary is published on FDA's Web site, through a method identified by 
FDA. FDA is seeking input on topics including consumer-oriented 
information submissions, consumer notifications, posting consumer 
notifications in grocery stores, and grocery stores subject to the new 
requirements.

DATES: Submit either electronic or written comments by June 9, 2014.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2013-
N-0590 or Regulatory Information Number (RIN) number 0910-AG97, by any 
of the following methods:

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 Agency name 
and Docket No. FDA-2013-N-0590 and RIN 0910-AG97 for this advance 
notice of proposed rulemaking. All comments received may be posted 
without change to http://www.regulations.gov, including any personal 
information provided. For additional information on submitting 
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION 
section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number(s), found in brackets in the heading of this document, 
into the ``Search'' box and follow the prompts and/or go to the 
Division of Dockets

[[Page 16699]]

Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ted Elkin, Center for Food Safety and 
Applied Nutrition (HFS-008), Food and Drug Administration, 5100 Paint 
Branch Pkwy., College Park, MD 20740, 240-402-2428; or April Hodges, 
Center for Veterinary Medicine (HFV-230), Food and Drug Administration, 
7519 Standish Pl., Rockville, MD 20855, 240-276-9237.

SUPPLEMENTARY INFORMATION:

I. Background

A. The Reportable Food Registry

    Section 1005 of the Food and Drug Administration Amendments Act of 
2007 (FDAAA) (Pub. L. 110-085) amended the FD&C Act by creating section 
417 entitled ``Reportable Food Registry'' (21 U.S.C. 350(f)). Under 
section 1005 of FDAAA, FDA established the RFR, an electronic portal 
that is used to submit mandatory and voluntary reports to FDA regarding 
``reportable foods.'' A ``reportable food'' is an article of food 
(other than dietary supplements or infant formula) for which there is a 
reasonable probability that the use of, or exposure to, such article of 
food will cause serious adverse health consequences or death to humans 
or animals (see section 201(ff) of the FD&C Act (21 U.S.C. 321(ff)) and 
section 417(a)(2) of the FD&C Act). Subject to certain exceptions, a 
``responsible party'' is required to submit a report to FDA through the 
RFR, as soon as practicable, but in no case later than 24 hours after 
determining that an article of food is a reportable food (see section 
417(d) of the FD&C Act). Under section 417(a)(1) of the FD&C Act, a 
``responsible party'' with respect to an article of food is defined as 
``a person that submits the registration under section 415(a) [of the 
FD&C Act (21 U.S.C. 350d)] for a food facility that is required to 
register under section 415(a), at which such article of food is 
manufactured, processed, packed, or held.'' The FD&C Act specifies that 
the term ``person'' includes individuals, partnerships, corporations, 
and associations (section 201(e) of the FD&C Act). A Federal, State, or 
local public health official may submit a report about a reportable 
food to FDA through the RFR (section 417(d)(3) of the FD&C Act).
    Several terms are used to describe the RFR system as a whole, as 
well as its components. Reportable food reports are submitted through 
the Department of Health and Human Services Safety Reporting Portal at 
http://www.safetyreporting.hhs.gov/, which we refer to in this document 
as ``the Safety Reporting Portal'' or ``SRP.'' The term ``Registry'' 
refers to the database maintained by FDA to catalogue reports that have 
been submitted through the Safety Reporting Portal, and that Agency 
review has determined to be reports for foods that meet the standard 
for ``reportable foods.'' The terms ``Reportable Food Registry'' and 
``RFR'' refer to the system as a whole. This terminology is consistent 
with terms FDA uses in its annual reports on the RFR. (See ``The 
Reportable Food Registry: A New Approach to Targeting Inspection 
Resources and Identifying Patterns of Adulteration: First Annual 
Report: September 8, 2009-September 7, 2010'' (January 2011); ``The 
Reportable Food Registry: Targeting Inspection Resources and 
Identifying Patterns of Adulteration: Second Annual Report: September 
8, 2010-September 7, 2011'' (April 2012); and ``The Reportable Food 
Registry: Targeting Inspection Resources and Identifying Patterns of 
Adulteration: Third Annual Report: September 8, 2011-September 7, 
2012'' (April 2013), available at http://www.fda.gov/ReportableFoodRegistry).
    The RFR reporting requirements cover reportable foods that are not 
under the exclusive jurisdiction of the U.S. Department of Agriculture, 
which include human food (except infant formula and dietary 
supplements) and animal food/feed (including pet food) regulated by 
FDA. (Other mandatory reporting systems exist for infant formula and 
dietary supplements.\1\) Submissions through the Safety Reporting 
Portal provide early warning to FDA about potential serious public 
health risks related to reportable foods and increase the speed with 
which the Agency and its partners at the State and local levels can 
investigate and take appropriate action, including ensuring that 
reportable foods are removed from commerce when necessary.
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    \1\ A manufacturer, packer, or distributor of a dietary 
supplement whose name appears on the label of a dietary supplement 
marketed in the United States must submit to FDA any report received 
of a serious adverse event associated with such dietary supplement 
when used in the United States, accompanied by a copy of the dietary 
supplement's label, under section 761 of the FD&C Act (21 U.S.C. 
379aa-1). Infant formula manufacturers must comply with notification 
requirements for violative infant formula in 21 CFR 107.240.
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    FDA's RFR does not receive reportable food reports from consumers 
through the Safety Reporting Portal. Instead, FDA has established other 
reporting forms for receiving and responding to consumer emergencies, 
complaints, questions, and concerns about FDA-regulated foods. (See, 
e.g., ``Your Guide to Reporting Problems to FDA'' at http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm095859.htm).
    Reportable food reports submitted by responsible parties or public 
health officials, such as Federal, State, or local public health 
officials, are categorized and tracked by FDA. The initial report 
concerning a reportable food that FDA generally receives from either a 
responsible party or a public health official is designated as the 
primary report for that reportable food. All other reports subsequently 
received from a responsible party (i.e., either by an immediate 
previous source (upstream) or an immediate subsequent recipient 
(downstream)) of a reportable food for which a primary report has been 
submitted are designated as subsequent reports. After consultation with 
the responsible party that submitted an initial report, FDA may require 
such responsible party to amend the initial report to include contact 
information for certain parties directly linked in the supply chain 
(section 417(d)(6)(A) of the FD&C Act). This type of report, which 
corrects or adds to an initial report, is an amended report. The 
responsible party may also provide corrections or add new information 
to a report at any time voluntarily. FDA may also require a responsible 
party that has submitted an initial report to notify the immediate 
previous source (upstream) or the immediate subsequent recipient 
(downstream) of the food for which the responsible party has submitted 
an initial report, if FDA deems necessary (see section 417(d)(6)(B) of 
the FD&C Act). If another responsible party, such as the immediate 
previous source or immediate subsequent recipient of the food, receives 
a notification regarding a food for which an initial report has been 
submitted, FDA may require such responsible party to submit a report to 
FDA regarding that reportable food (see section 417(d)(7) of the FD&C 
Act). This type of report, as indicated previously, is a subsequent 
report as it contains additional information regarding the reportable 
food from a responsible party other than the responsible party that 
submitted the initial report. If a responsible party receives a 
notification with respect to a food and the responsible party has 
already submitted an initial report or subsequent report to FDA with 
respect to such food, the responsible party is required to amend such 
report to include contact information for certain parties directly 
linked in the supply chain and provide the unique report number(s) 
issued through the Safety Reporting Portal for

[[Page 16700]]

report(s) (by which FDA is able to link reports about the reportable 
food and identify the supply chain) for such reportable food (see 
section 417(d)(8) of the FD&C Act).
    After reports are submitted to FDA through the Safety Reporting 
Portal, FDA reviews and assesses the information for purposes of 
identifying reportable foods, entering information into the Registry, 
issuing an alert as FDA deems necessary, and exercising other existing 
food safety authorities to protect the public health (see sections 
417(b)(2) and (c) of the FD&C Act).
    Due to the potential for confusion, it is important to explain that 
there are key differences between FDA's RFR and food recall programs. 
Generally, FDA's food recall program has been the primary channel of 
food product safety communication between FDA, consumers, and others in 
the supply chain. The RFR is a separate program, and its general 
purpose has been to provide a ``reliable mechanism to track patterns of 
adulteration in food . . . [to] support efforts by the [FDA] to target 
limited inspection resources to protect the public health'' (Pub. L. 
110-085, section 1005(a)(4)). Where the food recall program would, in 
part, gather and communicate information helpful to consumers who may 
encounter a recalled food, such as safe product disposal instructions, 
the RFR gathers information to identify and track a reportable food in 
the supply chain. The FSMA amendments to section 417 of the FD&C Act 
will give the RFR a greater role in informing the public in the event 
of a potential public health emergency.

B. FSMA Amendments to the Reportable Food Registry

    On January 4, 2011, FSMA (Pub. L. 111-353) was signed into law. 
FSMA generally amended the FD&C Act to provide for a modernized, 
prevention-based food safety system. FSMA amended section 417 of the 
FD&C Act, which governs the RFR, in relevant part by adding paragraphs 
(f), (g), and (h) (Pub. L. 111-353, 124 Stat. 3885, 3951-3953). Section 
417(f), as amended by FSMA, provides that, within 18 months after the 
date of enactment of FSMA, the Secretary of Health and Human Services 
(the Secretary) (and by delegation, FDA) may require a responsible 
party to submit to FDA ``consumer-oriented information'' regarding a 
reportable food with the exception of fruits and vegetables that are 
raw agricultural commodities. The consumer-oriented information must 
include the following: (1) A description of the article of food; (2) 
affected product identification codes, such as the Universal Product 
Code (UPC), stock keeping unit (SKU), or lot or batch numbers 
sufficient for the consumer to identify the article of food; (3) 
contact information for the responsible party; and (4) any other 
information FDA determines is necessary to enable a consumer to 
accurately identify whether such consumer is in possession of the 
reportable food (section 417(f)(4) of the FD&C Act). Section 417(g)(1) 
of the FD&C Act, as amended by FSMA, requires FDA to prepare the 
consumer-oriented information described in section 417(f) as a 
standardized one-page summary, and publish the one-page summary on 
FDA's Web site in a format that can be easily printed by a grocery 
store for purposes of consumer notification.
    A grocery store that is part of a chain of establishments with 15 
or more physical locations (``chain grocery store'') that sold a 
reportable food that is the subject of a one-page summary published on 
FDA's Web site must notify consumers by: (1) Prominently displaying the 
one-page summary or information from such summary, through a method 
described in section 417(h)(2) of the FD&C Act, no later than 24 hours 
after the one-page summary is published on FDA's Web site, and (2) 
maintain the display for 14 days (section 417(h)(1) of the FD&C Act). 
The chain grocery store must also include in the consumer notification 
the date and time that the one-page summary was posted on the FDA's Web 
site (section 417(g)(2) of the FD&C Act).
    Section 417(h)(2) of the FD&C Act, as amended by FSMA, requires 
that, within 1 year after the date of enactment of FSMA, FDA develop 
and publish ``a list of acceptable conspicuous locations and manners'' 
from which a chain grocery store must select at least one method for 
displaying a consumer notification about the reportable food. Section 
417(h)(2) provides that the list of acceptable conspicuous locations 
and manners must include the following:
     ``Posting the notification at or near the register;''
     ``Providing the location of the reportable food;''
     ``Providing targeted recall information given to customers 
upon purchase of food;'' and
     ``Other such prominent and conspicuous locations and 
manners utilized by grocery stores as of the date of the enactment of 
[FSMA (i.e., as of January 4, 2011)] to provide notice of such recalls 
to consumers as considered appropriate by the Secretary.''
    While sections 417(f) and 417(h)(2) of the FD&C Act include 
statutory deadlines within 18 and 12 months of the enactment of FSMA, 
respectively, FDA is issuing this ANPRM, rather than a notice of 
proposed rulemaking, to solicit further input from the public regarding 
issues related to the FSMA amendments to section 417 of the FD&C Act. 
As discussed in the paragraphs that follow, FDA believes that the 
information it obtains through this ANPRM will assist the Agency in 
implementing and efficiently enforcing the FSMA amendments to section 
417 of the FD&C Act.

II. June 6, 2011, Public Meeting and Request for Comments

    On May 26, 2011, FDA issued a Federal Register notice announcing a 
public meeting scheduled for June 6, 2011, entitled ``FDA Food Safety 
Modernization Act: Focus on Inspections and Compliance'' (FSMA public 
meeting notice) and requesting comments (76 FR 30727). The purpose of 
the public meeting was to provide interested persons an opportunity to 
discuss implementation of inspections and compliance under FSMA, and to 
give the public an opportunity to provide information and share views 
to inform FDA's FSMA implementation strategies related to, among other 
things, implementation of the new provisions in section 417 of the FD&C 
Act. The FSMA public meeting notice presented the following questions 
related to the FSMA amendments to section 417 of the FD&C Act:
     What information is necessary to enable a consumer to 
accurately identify whether the consumer is in possession of a 
reportable food?
     What methods could best be used by grocery stores to 
inform consumers of information to enable them to identify whether they 
possess a reportable food?
     Are there other approaches to getting key information in 
the hands of consumers in real time that FDA should also consider 
pursuing?
     Who should FDA consider to be a grocery store subject to 
the consumer notification requirement in section 417(h) of the FD&C 
Act?
     What methods are grocery stores currently using to provide 
notice of food recalls to consumers?
    At the public meeting, FDA provided opportunities for individuals 
to make presentations during an open public and Webcast comment 
session. A transcript of FDA's remarks at the opening session, the open 
public and Webcast comment session, and the listening session is 
available on FDA's Web site at (http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm255954.htm). No public comments regarding 
the FSMA amendments to

[[Page 16701]]

section 417 of the FD&C Act were received during the public meeting 
sessions. Stakeholders were given other opportunities to express their 
views during breakout sessions focused on specific topics, including a 
session on section 417 of the FD&C Act. These sessions were not 
recorded.
    In the FSMA public meeting notice, FDA also requested comments, and 
noted that electronic or written comments could be submitted to the 
Division of Dockets Management regardless of whether commenters 
attended the public meeting. FDA opened Docket No. FDA-2011-N-0366 for 
public comments. In response to this request, FDA received three 
comments. The comments were from trade associations and a consumer 
group. These comments are discussed in section III.

III. Issues and Requests for Data and Information

    As noted previously, FDA only received three comments regarding the 
FSMA amendments to section 417 of the FD&C Act. While these comments 
provided useful input, additional input from the public would assist 
the Agency in implementing and efficiently enforcing the FSMA 
amendments to section 417 of the FD&C Act. In addition to the issues 
described in the FSMA public meeting notice, there are several other 
issues related to the new requirements in section 417 for which FDA 
believes further comment, data, and information would be helpful to the 
Agency in implementing and enforcing the new requirements. As discussed 
in the paragraphs that follow, FDA is soliciting input regarding what 
information responsible parties should be required to provide to the 
Agency in consumer-oriented information submissions for reportable 
foods to enable consumers to accurately identify whether they possess 
such foods, as specified in section 417(f)(4) of the FD&C Act (FDA 
``may require a responsible party to submit to [FDA] consumer-oriented 
information regarding a reportable food, which shall include . . . any 
other information [FDA] determines is necessary to enable a consumer to 
accurately identify whether such consumer is in possession of the 
reportable food.''). FDA anticipates that additional input from the 
public, including consumers and stakeholders, regarding what 
information would allow consumers to determine whether they possess 
reportable foods will be critical in FDA's implementation of section 
417(f) of the FD&C Act.
    FDA is also soliciting input regarding manners and locations used 
by grocery stores to provide food recall information to consumers, as 
specified in section 417(h)(2) of the FD&C Act (FDA ``shall develop and 
publish a list of acceptable conspicuous locations and manners, from 
which grocery stores shall select at least one, for providing the 
notification required in [section 417(h)(1) of the FD&C Act] . . . 
[which] shall include . . . other such prominent and conspicuous 
locations and manners utilized by grocery stores as of the date of the 
enactment of [FSMA] to provide notice of such recalls to consumers . . 
.''). There may be several manners and locations in which grocery 
stores provide or have provided food recall information to consumers. 
Further, grocery stores and consumers can provide more information to 
FDA regarding these manners and locations, including the advantages and 
disadvantages of particular approaches.
    In addition, FDA is soliciting information regarding potential 
impacts to and costs incurred by chain grocery stores related to 
posting consumer notifications, as required by section 417(h) of the 
FD&C Act. Because grocery stores likely have experience with providing 
notices to consumers, these stores likely have data and information 
that could assist the Agency in estimating associated costs and burdens 
related to compliance. Such information could also assist the Agency in 
establishing requirements to efficiently enforce the FSMA amendments to 
section 417 of the FD&C Act.
    FDA anticipates that information from stakeholders and the public 
regarding these issues, along with the other issues described in the 
paragraphs that follow, will significantly assist the Agency in 
developing requirements to implement section 417 of FD&C Act and 
efficiently enforce such requirements. For these reasons, FDA is 
issuing this ANPRM to solicit additional comments, data, and other 
information related to the FSMA amendments to section 417 of the FD&C 
Act.

Issue 1: Consumer-Oriented Information Submissions and Consumer 
Notifications

    Question 1a: What information should FDA require be included in 
consumer-oriented information submissions and consumer notifications 
for a reportable food to enable a consumer to accurately identify 
whether he or she is in possession of the reportable food?
    Section 417(f) of the FD&C Act provides that the consumer-oriented 
information submitted to FDA by a responsible party must include: (1) A 
description of the article of food; (2) affected product identification 
codes, such as UPC, SKU, or lot or batch numbers sufficient for the 
consumer to identify the article of food; (3) contact information for 
the responsible party; and (4) ``any other information the Secretary 
determines is necessary to enable a consumer to accurately identify 
whether such consumer is in possession of the reportable food.'' 
Section 417(g)(1) requires that FDA prepare the consumer-oriented 
information as a standardized one-page summary and publish such one-
page summary on FDA's Web site in a format that can be easily printed 
by grocery stores for the purposes of consumer notification. In 
response to a similar question presented in the FSMA public meeting 
notice, two commenters asserted that the consumer-oriented information 
should include the reason for the recall of the reportable food, if 
applicable. Another commenter recommended that the consumer-oriented 
information include a picture of the product and product label, state 
when the product was sold, and state what consumers should do with the 
product.
    FDA is interested in additional data and information regarding what 
information should be required in consumer-oriented information 
submissions and consumer notifications for reportable foods to enable a 
consumer to accurately identify whether such consumer is in possession 
of the reportable food. FDA is also interested in data and information 
regarding whether the one-page summary of consumer-oriented information 
posted at FDA's Web site should contain other information, such as 
advice to consumers on disposing of a reportable food product.
    Question 1b: Should FDA require responsible parties to submit 
consumer-oriented information to FDA, as described in section 417(f) of 
the FD&C Act, for reportable foods that are not available, or will not 
be available, for sale to consumers in chain grocery stores or 
otherwise available for sale to consumers at the retail food market?
    As noted previously, a ``responsible party'' generally is required 
to submit a report to FDA through the Safety Reporting Portal, as soon 
as practicable, but in no case later than 24 hours after determining 
that an article of food is a reportable food (see section 417(d) of the 
FD&C Act). In addition, section 417(f) of the FD&C Act provides that 
FDA may require a responsible party to submit to FDA consumer-oriented 
information regarding a reportable food (except for fruits and 
vegetables that are raw agricultural commodities). It is

[[Page 16702]]

possible that there may be a reportable food, for which a responsible 
party is required to submit a report to FDA through the Safety 
Reporting Portal under section 417(d), that has not or will not reach 
the retail food market, including chain grocery stores. For example, 
many reportable food reports concern food ingredients and bulk 
commercial products that are not sold at the retail level. One of the 
purposes of the RFR is to identify makers of foods sold at retail who 
have received an ingredient that is the subject of a reportable food 
report to stop shipment of possibly contaminated foods before they are 
sold at retail. Under section 417(f) of the FD&C Act, a responsible 
party may also be required to submit to FDA consumer-oriented 
information for such a reportable food. Section 417(h)(1) makes clear 
that unless a chain grocery store sold a food that is the subject of a 
one-page summary published by FDA, the grocery store is not required to 
post a consumer notification described in section 417(g) about such 
food. FDA is interested in comments or other information regarding 
whether FDA should require responsible parties to submit the consumer-
oriented information described in section 417(f) for all reportable 
foods, including those that have not been available, or will not be 
available, for sale to consumers in chain grocery stores or otherwise 
available for sale to consumers at the retail food market.
    Question 1c: FDA is interested in additional data and information 
from industry and consumer groups regarding consumer preferences for 
receiving information. For the one-page summaries of consumer-oriented 
information prepared by FDA and published on FDA's Web site, what 
structure and format would be the most useful to grocery stores and 
consumers? To what extent, if any, should the consumer-oriented 
information be provided in languages other than English?
    Question 1d: Should FDA revise and republish a one-page summary of 
consumer-oriented information on FDA's Web site if the published 
information no longer provides the information necessary to enable a 
consumer to accurately identify whether such consumer is in possession 
of the reportable food? For example, a recall expanding to include 
additional lots, and corrections in amended industry reports could 
create this scenario. If a one-page summary is revised and republished 
on FDA's Web site, should this trigger additional posting obligations 
for chain grocery stores?
    Question 1e: What mechanisms can be employed so that chain grocery 
stores are aware that a one-page summary of consumer-oriented 
information for a reportable food has been published on the Agency's 
Web site, or that a previously published one-page summary has been 
revised?

Issue 2: Grocery Stores

    Question 2a: What types of retail establishments should FDA 
consider to be ``grocery stores'' within the meaning of section 417(h) 
of the FD&C Act? Section 417(h)(1) provides in relevant part that if a 
chain grocery store sold a reportable food that is the subject of a 
one-page consumer-oriented information summary published on FDA's Web 
site, the chain grocery store must prominently display the one-page 
summary or information from the one-page summary within 24 hours after 
the one-page summary is published on FDA's Web site and maintain such 
display for 14 days. The FD&C Act does not define the term ``grocery 
store.'' FDA requests comment on what types of retail establishments 
should be subject to the consumer notification requirements of section 
417(h). Please provide an explanation for your response and any 
supporting data.
    Comments that FDA received in response to the FSMA public meeting 
notice supported a broad definition of the term ``grocery store'' to 
encompass all retail establishments in which the sale of groceries is a 
primary business activity, including supermarkets, warehouse stores, 
wholesale club stores, convenience stores, and other stores that are 
part of a chain. One commenter noted that consumers may buy groceries 
online from both grocery store chains and other online retailers, and 
stated that these retailers should also be required to provide the 
consumer notifications described in section 417(h) of the FD&C Act. Two 
commenters recommended that, in developing a definition of the term 
``grocery store'' for purposes of implementing section 417(h), FDA 
consider the definition of ``retail food establishment,'' which 
includes grocery stores, in FDA's regulations for registration of food 
facilities at 21 CFR 1.227(b)(11).

Issue 3: Posting Consumer Notifications

    Question 3a: How can a chain grocery store prominently display or 
provide a consumer notification via a conspicuous location or manner as 
described in section 417(h)(2) of the FD&C Act? Section 417(h)(1) of 
the FD&C Act provides in relevant part that if a chain grocery store 
sold a reportable food that is the subject of a one-page consumer-
oriented information summary published on FDA's Web site, the chain 
grocery store must ``prominently display such summary or the 
information from such summary via at least one of the methods 
identified in [section 417(h)(2)].'' Section 417(h)(2) provides in 
relevant part that FDA shall develop and publish ``a list of acceptable 
conspicuous locations and manners, from which grocery stores shall 
select at least one, for providing [consumer notifications].'' Further, 
section 417(h)(2) provides that such list must include: (1) Posting the 
notification at or near the register; (2) providing the location of the 
reportable food; (3) providing targeted recall information given to 
customers upon purchase of a food; and (4) other such prominent and 
conspicuous locations and manners utilized by grocery stores as of the 
date of enactment of FSMA (i.e., January 4, 2011) to provide notice of 
such recalls to consumers as considered appropriate by FDA.
    Question 3b: How can a chain grocery store prominently display or 
provide a consumer notification ``at or near the register'' as 
described in section 417(h)(2)(A) of the FD&C Act?
    Question 3c: How can a chain grocery store prominently display or 
provide a consumer notification in a way that provides ``the location 
of the reportable food,'' as described in section 417(h)(2)(B) of the 
FD&C Act?
    Question 3d: How can a chain grocery store prominently display or 
provide a consumer notification in a way that provides ``targeted 
recall information given to customers upon purchase of a food,'' as 
described in section 417(h)(2)(C) of the FD&C Act?
    Question 3e: Section 417(h)(2) of the FD&C Act requires FDA to 
develop and publish a ``list of acceptable conspicuous locations and 
manners'' for chain grocery stores to post the consumer notifications 
described in section 417(g), and describes certain locations and 
manners. Section 417(h)(2)(D) provides in relevant part that such a 
list must include ``other such prominent and conspicuous locations and 
manners utilized by grocery stores as of the date of enactment of 
[FSMA] to provide notice of . . . recalls to consumers as considered 
appropriate by [FDA]''. What methods, manners, and/or locations, if 
any, have grocery stores or other retail food establishments used to 
effectively notify consumers about food recalls?
    One comment that FDA received in response to the FSMA public 
meeting notice stated that FDA regulations implementing the consumer 
notification requirements of section 417 of the FD&C

[[Page 16703]]

Act or related guidance should provide retailers with the flexibility 
to choose among different approaches to notifying consumers about food 
recall information. The commenter stated that the regulations should 
``afford the opportunity for new ideas and modes of notification and 
not be so prescriptive as to limit innovation.'' Section 417(h)(2)(D) 
of the FD&C Act specifies that the other manners and locations that 
must be included on the list developed and published by FDA (as 
considered appropriate by FDA) are those used by grocery stores as of 
the date of enactment of FSMA to provide notice of food recalls that 
are ``conspicuous'' and ``prominent.'' In light of this requirement, 
FDA is particularly interested in data and information on the most 
innovative and effective approaches used by grocery stores or other 
retail food establishments to notify consumers about food recalls in 
manners and locations that are conspicuous and prominent.
    One commenter recommended that, where purchases of food have 
occurred over the Internet, electronically contacting consumers is 
effective because the retailer knows exactly what the consumer 
purchased and has reliable contact information for the consumer. The 
commenters noted that these consumers may never see a posting in a 
physical store. Two commenters recommended the use of loyalty cards as 
a tool to notify customers. One of these commenters cited a report by a 
retailer that noted that the retailer was able to electronically notify 
90 percent of purchasers (17 of 19) of a recalled food item.
    One commenter stated that retailers currently notify consumers of 
food recalls by: (1) Posting information at or near the register; (2) 
posting information at the area where the food is displayed; (3) 
loyalty card or membership notifications by email, phone, or mail; (4) 
providing printout information to consumers at checkout; (5) Web site 
posting; (6) posting information at kiosks in the store; and (7) 
posting information on a bulletin board or similar information area. 
The comment suggested that FDA allow retailers to choose one or more 
manners of notification, or use different manners for different 
recalls. The commenter identified factors that may be relevant to the 
manner used, including the size of recall; whether the product was 
distributed nationally or more narrowly; the type of product; the 
target customers; the shelf life of the product, and the product's use 
as an ingredient in other foods.
    Question 3f: What factors could influence a chain grocery store's 
decision about whether to display a one-page summary of consumer-
oriented information regarding a reportable food as published on FDA's 
Web site, or instead to display the information from the FDA summary?
    Section 417(h)(1) of the FD&C Act requires in relevant part that 
chain grocery stores prominently display, in the prescribed timeframe, 
either the consumer-oriented information one-page summary published on 
FDA's Web site ``or the information from such summary.''
    Question 3g: Could compliance with the consumer notification 
requirements of section 417(h) of the FD&C Act by chain grocery stores 
affect the voluntary or mandatory display of other information 
regarding a food recall by retail establishments?
    One commenter stated that food retailers receive product recall 
notifications primarily from their suppliers or manufacturers, usually 
before the information is provided by FDA or through the RFR. The 
commenter stated that in addition to removing the product from sale, 
food retailers take action to notify consumers. The commenter argued 
that if FDA links notifying consumers about recalls to the RFR one-page 
summaries prepared by FDA and published on FDA's Web site, it could 
result in a delay compared to current practices for notifying consumers 
about recalls, or could result in duplicative notices. The commenter 
recommended that food retailers who notify consumers about food recalls 
before FDA information is available not be required to provide any 
subsequent notifications, unless information about the recall has 
changed.
    FDA is interested in receiving further comment on the issues raised 
in these comments. We note that nothing in the new requirements in 
section 417 of the FD&C Act precludes a chain grocery store from 
posting its own notice regarding a food recall before FDA publishes on 
its Web site a one-page summary of consumer-oriented information 
regarding a reportable food. However, regardless of the actions a 
responsible party or grocery store may take prior to FDA's publication 
of a one-page summary, the consumer notification requirements of 
section 417(h) would still apply. Accordingly, if a chain grocery store 
sold a reportable food that is the subject of a one-page summary, the 
grocery store would still be required to prominently display the one-
page summary or the information from the summary within 24 hours after 
the summary is published on FDA's Web site and must maintain the 
display for 14 days.
    Question 3h: What, if any, impact will the consumer notification 
requirements in section 417(h) have on grocery store operations? For 
example, how might the requirements affect resources if resources are 
spent monitoring FDA's Web site for new consumer notifications to be 
posted, or resources are spent posting such notifications or the 
information from such notifications?
    Question 3i: What are the estimated costs to chain grocery stores, 
per store and per reportable food, associated with displaying consumer 
notifications as required by section 417(h)?
    Question 3j: How much time (hours per reportable food) is currently 
used by grocery store and other retail food establishment employees 
(including managers) to notify consumers about reportable foods? What 
is the estimated change, if any, in the time spent on notifying 
consumers about reportable foods as a result of the consumer 
notification requirements in section 417(h) of the FD&C Act?
    Question 3k: Should chain grocery stores be permitted to use 
multiple manners and locations, as identified by FDA, to post consumer 
notifications consecutively for a total of 14 days?
    Section 417(h)(1) of the FD&C Act provides in relevant part that a 
chain grocery store that sold a reportable food that is the subject of 
a one-page summary published on FDA's Web site must prominently display 
such summary or the information from such summary, and maintain such 
display for 14 days. One commenter suggested that the 14-day time 
period should begin when the retailer first notifies consumers about a 
recall. Further, the commenter stated that for other methods of 
informing consumers about food recalls a 14-day duration might not be 
practicable (e.g., repeated phone calls to the same consumer for 14 
days). The commenter also stated that the 14-day time period should 
include all notification manners used by the grocery store. The 
commenter noted, as an example, that a grocery could post a sign for 2 
days notifying consumers about a recall for a food product whose shelf 
life is long past, and then the grocery store could post the 
information for the next 12 days on the retailer's Web site. Because of 
the statutory terms in section 417(h) of the FD&C Act regarding a chain 
grocery store ``prominently display[ing]'' an FDA one-page summary or 
information from such summary and ``maintain[ing] the display for 14 
days,'' it seems unlikely that the telephone calls described in the 
comment would satisfy section 417(h).

[[Page 16704]]

FDA is interested in further comment and information regarding manners 
and locations for posting consumer notifications for the 14-day time 
period specified in section 417(h).

Issue 4: Other Issues

    Question 4a: As noted previously, the term ``reportable food'' does 
not include dietary supplements or infant formula (see sections 201(ff) 
and 417(a)(2) of the FD&C Act). Further, as discussed previously, 
section 417(f) of the FD&C Act, as amended by FSMA, provides that FDA 
may require a responsible party to submit to FDA ``consumer-oriented 
information'' regarding a reportable food with the exception of fruits 
and vegetables that are raw agricultural commodities. Based on these 
exceptions and exclusions, responsible parties may not submit to FDA 
consumer-oriented information, under section 417(f) of the FD&C Act, 
for dietary supplements, infant formula, and fruits and vegetables that 
are raw agricultural commodities. There may be potential public health 
impacts if consumer notifications for reportable foods do not include 
information on dietary supplements, infant formula, and fruits and 
vegetables that are raw agricultural commodities, particularly if the 
public believes that such consumer notifications are meant to encompass 
all food products regulated by FDA. FDA seeks comments or other 
information on whether consumer notifications posted by chain grocery 
stores, as specified by section 417(h) of the FD&C Act, should include 
information advising consumers that such notifications do not cover 
certain foods, such as a statement asserting that the consumer 
notifications do not include reportable food or recall information for 
dietary supplements, infant formula, and fruits and vegetables that are 
raw agricultural commodities, and consumers should consult FDA's Web 
site for any relevant information for these products.
    Question 4b: There may be a situation where FDA is aware of a class 
1 recall for a reportable food for which a responsible party would be 
required to submit to FDA consumer-oriented information for such 
reportable food under section 417(f) of the FD&C Act, but the 
responsible party failed to submit such information to FDA. In such 
situations, should FDA prepare and publish a one-page summary of 
consumer-oriented information, if known, for such reportable food, and 
require chain grocery stores that sold the reportable food to post such 
summary or the information from such summary, as specified in section 
417(h) of the FD&C Act?

IV. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.
    Please note that this is not related to the request in the Federal 
Register of May 25, 2010 (75 FR 29350) (Docket No. FDA-2009-D-0260), 
for comments regarding the finalization of the current RFR, 2d Edition, 
draft guidance.

    Dated: March 20, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-06614 Filed 3-25-14; 8:45 am]
BILLING CODE 4160-01-P