The FDA is proposing a new regulation that amends the current requirements for any business that holds, stores, manufactures, or processes food (termed “food facility”) to register each location with the FDA.
The Tester-Hagan amendment to the federal Food Safety Modernization Act sought to reduce the scope of this pre-existing requirement by exempting any food business that sells the majority of its food directly to consumers at locations such as roadside stands and farmers markets. The amendment directed FDA to develop a list of other direct-to-consumer venues that would be considered, and the agency has developed a rather comprehensive list. But the FDA’s proposed rule only exempts farms selling at such direct-to-consumer locations — leaving many small artisan food producers subject to unnecessary regulation.
In addition, for those businesses that must register, the proposed rule requires electronic registration and a contact email address. The proposed rule also requires that every food business also register with Dun & Bradstreet’s system to get a universal number, which is then also filed with the FDA. These new requirements will burden small food businesses whose owners do not have convenient internet access or use email regularly, whether for religious or practical reasons.
The FDA is accepting public comments on the proposed rule – please support local food producers by speaking up now!
Deadline: June 8, 2015
BY MAIL: Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane
Rockville, MD 20852
Be sure to include “Docket No. FDA-2002-N-0323” on the top of your comments if you mail them
I am a ____________ (farmer, food manufacturer, local foods consumer ….).
I support the list of direct-to-consumer venues in section 1.227(b)(11)(iii), as including door-to-door sales, mail, catalog and internet orders, nonprofit events, and fairs.
I urge the FDA to make the following changes to its proposed rule for facility registration:
1) Comply with the Tester-Hagan language of FSMA, and exempt all facilities that sell more than half of their products directly to consumers at roadside stands, farmers’ markets, and similar locations. The exemption should not be limited to facilities that are located on farms.
2) Similarly, the definition of roadside stands should not be limited to farmers, and the definition of farmers’ market should recognize that food vendors besides farmers may also sell at such markets. I agree that the majority of the vendors at a market should be farmers for it to be classified as a “farmers market,” but artisan food providers have an important role in these markets as well.
3) Clarify the process for getting a waiver from registering electronically. The regulation should specifically recognize religious objections and lack of reasonable access to the internet as reasons to grant a waiver, in addition to such other issues as may be raised by applicants.
4) Provide an exemption for those who do not have email addresses as a regular contact.
5) Eliminate the requirement for a D-U-N-S number or make it optional information to be submitted if the location already has a D-U-N-S number. It does not make sense to require a small business to register with Dun & Bradstreet for the sole reason of then also registering with the FDA.
Issues 1 & 2: Definition of retail food establishment
The registration requirement for food facilities was first created under the 2002 Bioterrorism Act, and then amended by Congress under the Food Safety Modernization Act of 2010. The Bioterrorism Act exempted both “farms” and “retail food establishments” from the definition of “facilities” that had to register with FDA, but did not define the term.
In the original regulations, FDA defined “farms” very narrowly to include only those farms that were doing no food processing – even making sun-dried tomatoes or salad mixes would turn a “farm” into a “facility” that had to register.
FDA’s definition of “retail food establishments” was broader, encompassing any establishment whose primary function was to sell directly to consumers, defined as selling more than half of the products directly to individual consumers. However, since the Bioterrorism Act focused on registration of each location, the sales had to occur at the same location as the food processing in order to qualify. In other words, a business that made jams in a commercial kitchen and then sold them at a farmers’ market would not be a “retail food establishment” – and would have to register with FDA – even if more than half of its sales were direct to individual consumers.
The Food Safety Modernization Act (FSMA) in 2010 built on the registration requirement of the earlier Bioterrorism Act. Unless exempted, facilities that have to register under the Bioterrorism Act will now have to meet extensive paperwork requirements and more.
The Tester-Hagan amendment responded by exempting some producers, and by seeking to address the definition of “retail food establishment.” The amendment to FSMA stated:
(1) Retail food establishment.–The Secretary shall amend the definition of the term “retail food establishment” in section 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–
(A) the sale of such 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;
(B) the sale and distribution of such food through a community supported agriculture program; and
(C) the sale and distribution of such food at any other such direct sales platform as determined by the Secretary.
This language addresses all food businesses, not just those that are located on farms. Yet, in proposing regulations to implement this section, FDA is limiting it to just those operations that are located on farms.
The agency must comply with the Tester-Hagan language of FSMA, and exempt all facilities that sell more than half of their products directly to consumers at roadside stands, farmers’ markets, and similar locations.
Similarly, the FDA also limited the impact of this amendment by limiting roadside stands and farmers’ markets to only farmers. While we agree that the majority of the vendors at a market should be farmers, for it to be classified as a “farmers market,” artisan food providers have an important role in these markets. There are very few farmers’ markets in the country that have only farmers, and limiting the definition in this way significantly undermines the scope of the exemption.
Issue 3: Electronic registration
FSMA also amended the Bioterrorism Act by allowing FDA to require electronic registrations. But Congress made it discretionary, leaving it up to FDA whether or not to mandate it.
The FDA has chosen to require electronic registration. The agency has included a process for getting a waiver, but the proposed rule does not include any listing of the grounds for a waiver. In other words, you can apply for a waiver and then simply hope that FDA grants it.
This is not fair to people who have legitimate religious objections to using the internet, as well as the many people who still do not have reasonable access to the internet, a common issue in rural and low-income areas.
The agency should clarify the process for getting a waiver from registering electronically under section 1.245. The regulation should specifically recognize religious objections and lack of reasonable access to the internet as reasons to grant a waiver, in addition to such other issues as may be raised by applicants.
Issue 4: Email contact address
FSMA added “email address” to the list of information that should be submitted by a food facility in its registration. But just as many people do not have regular internet access for religious or practical reasons, even more people either do not have an email address or do not check email regularly.
The FDA has attempted to address this problem in its proposed rule by providing that the registrant can list the email address of someone other than the owner or manager. While this is a partial solution, it still assumes that the owner of the food business has a trustworthy contact person who has an email address and reliable, regular access.
The problem is exacerbated by FDA’s intentions for communicating through email. The stated reason for using email as a method of contact is the ability to reach people quickly in an emergency. But if a facility owner or manager doesn’t even have their own email address, or if they only access email occasionally, then relying on email for communicating during an emergency is counter-productive!
The proposed rule should be amended to provide an exemption for those who do not have email addresses. The proposed rule should also be amended so that food facilities can indicate their preferred means of contact in an emergency on the registration form. That way, the FDA has the most reliable means for contacting the business when necessary.
Issue 5: DUNS Number
The D-U-N-S number is a global numbering system managed by Dun & Bradstreet to support business’s credit reporting work.
The proposed rule would require a food facility so include a D-U-N-S number when registering with FDA; if the business does not already have such a number, it would have to go register with Dun & Bradstreet first, in order to complete the mandatory registration with FDA. FSMA made no reference at all to this system; FDA proposed this new requirement on its own initiative.
FDA’s rationale for requiring a D-U-N-S number is simply as a cross-check on the accuracy of the information submitted to FDA for the facility registration. But if a business only gets a D-U-N-S number for the purpose of registering with FDA, then there’s no real purpose. It cannot serve as an effective way to prevent unauthorized agents or other inaccurate information from being submitted, if the facility is the entity submitting the same information to both the DUNS system and FDA’s registration system. Rather, it serves only as an additional time-consuming step.
Moreover, some individuals would have religious objections to registering in the D-U-N-S system because it involves a mandatory universal numbering system.
For purposes of serving as a way to confirm the accuracy of the registration information, the DUNS number is only of use if it pre-dates the facility registration. FDA could choose to require that, if the facility has a DUNS number, that it be included in the facility registration. This would achieve FDA’s stated objective without creating unnecessary burdens.