Reaching Consumers with Product Safety Information - A Challenge for FSMA Regulation

On March 26th, FDA issued advanced notice of their proposed 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(link). In summary, FDA is looking for a way to communicate food safety product notices (recalls) to consumers. The objectives are for companies to provide standardized information to FDA, FDA to develop a one-page recall notice regarding that food safety issue with a reportable food, and then that notice will then be distributed by the retail outlets, or grocery chains, to the consumers.

 

Sounds easy enough, however, there are many challenges in establishing a protocol that will work. Chiefly among them is the fact that consumers are not an easy group to reach with recall this type of information. So how do retailers do this to a point where it is not costly? And from a practical standpoint, will this mandated system have an impact compared to what currently happens today?

 

This has implications for the manufacturers, but more so for the grocery chains.

 

Here is a ‘quick’ summary, much taken directly from the seven page document published in the Federal Register.

 FDA established the RFR, an electronic portal that is used to submit mandatory and voluntary reports to FDA regarding ‘‘reportable foods’ to assist FDA in targeting inspection resources and identifying patterns of adulteration.’ 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.  

 

Reportable food reports are submitted by responsible parties or public health officials, such as Federal, State, or local public health officials, are categorized and tracked by FDA. This includes reports from companies who have purchased food where in their testing, discovered a pathogen. Many reported cases have been from state health agencies.

 

(FDA’s RFR does not receive reportable food reports from consumer 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. For this information, see,‘‘Your Guide to Reporting Problems to FDA’’ at http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm095859.htm).

 

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.

 

Note, the RFR is different than a food recall program, although they are linked. 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’’

 

As part of the RFR requirement within FSMA, FDA may require a responsible party to submit ‘‘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. requires FDA to prepare the consumer oriented information 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 an approved method no later than 24 hours after the one-page summary is published on FDA’s Web site,

(2) maintaining the display for 14 days

 

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. FDA will 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.’’

 

What other information may be needed - 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.

 

 Another issue is that it is 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, a company produces an ingredient used by other manufacturers and that ingredient becomes the subject of a recall.

 

FDA is interested in additional data and information from industry and consumer groups regarding consumer preferences for receiving information. They posed the following questions.

• 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?
• 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?
• 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?
• What types of retail establishments should FDA consider to be ‘‘grocery stores’’? The 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.
• 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? According to FSMA, FDA shall develop and publish ‘‘a list of acceptable conspicuous locations and manners, from which grocery stores shall select at least one, including (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.
• How can a chain grocery store prominently display or provide a consumer notification ‘‘at or near the register’’?
• 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?
• 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?
• What are acceptable conspicuous locations and manners’’ for chain grocery stores to post the consumer notifications?.
• 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?
• 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?
• What, if any, impact will the consumer notification requirements in section 417(h) have on grocery store operations?
• 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)?
• 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?
• 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?