FDA Requests Your Comments on Proposed FSMA Water Extension
Updated: Jul 24, 2020
By Mayhah Suri
Last month, the U.S. Food and Drug Administration (FDA) filed a formal notice of proposed rulemaking to extend the compliance dates for the agriculture water requirements of the Produce Safety Rule section of the Food Safety Modernization Act (FSMA). The new proposed dates for agricultural water compliance vary based on farm size:
January 26, 2022 for the largest farms (more than $500,000 in average annual sales for the 3 previous years)
January 26, 2023 for small farms (between $250,000 and $500,000 in average annual produce sales for the previous 3 years)
January 26, 2024 for very small farms (between $25,000 and $250,000 in average annual sales for the previous 3 years)
The proposed rule is open for public comment until November 13, 2017, 60 days after the proposal was announced in September.
FDA’s Proposed Rule
As it currently stands, the Produce Safety Rule has established criteria for microbial water quality based on the presence of generic E. coli, which can indicate the presence of fecal contamination. Compliance to these agriculture water standards requires farmers to test their water sources. There are different testing requirements based on the water source, such as surface water or ground water, including how many times the water must be tested.
The proposed rule extends the compliance dates for these agricultural water requirements by an additional two to four years for produce other than sprouts. FDA says this proposed extension gives them time to figure out if the water standards are feasible for farmers across the country. Sprouts are not included in the extension “because of their unique vulnerability to contamination,” and will still be subject to the applicable agricultural water requirements from the final rule, and the original compliance dates.
The proposed extension also resets the compliance framework so that all of the water requirements would get a four-year delay compared with farms’ primary compliance dates. The produce rule currently includes a delay of two years in the compliance dates for certain agricultural water requirements, but not for others. This extension uniformly changes all the agriculture water requirements to a four-year delay compared with the farm’s primary compliance dates, which vary based on farm size. The FDA also plans to engage with stakeholders (particularly farmers and state regulators) during this additional time, to better understand how water is used to ensure the water requirements are practical and effective.
The FDA states they will not take any enforcement actions on the agriculture water requirements during the rulemaking process until they decide whether or not to extend the dates. Additionally, inspections to assess compliance with the non-water requirements of the Produce Safety Rule for produce other than sprouts will not begin until 2019. Sprouts will still be subject to these requirements, however, and are not exempted from enforcement actions.
The Rulemaking Process and the Federal Register
FDA is telling the public they want to change the compliance dates, which means changing the rule. Buried behind sleep-inducing names like “Extension of Compliance Dates for Subpart E” lies an opportunity to have your voice heard. Under the Administrative Procedures Act, 5 USC §551 et. seq., whenever a federal agency wants to change a rule they must open a public notice and comment period as part of that rulemaking process. Anyone who believes they are affected by the change – good, bad, happy, sad – is eligible to comment. In a way, it’s like the original YouTube comments section. This all happens in the daily federal “journal” called the Federal Register. Journal is in quotes here because though the print version still exists, it’s easiest to access the Federal Register online and it looks nothing like most journals we may have read. The Federal Register, compiled by the National Archives and Records Administration, includes a record of every federal rule, Executive Order, all public notices, and proposed rules. For more information on the Register, check out this great history, including how the Register changed with the dawn of the Information Age.
The goal of the notice and comment period, also called an open comment or public comment period, is to engage the public in rulemaking. Any person or organization may comment on a rule in writing or orally at a hearing. Many agencies, including FDA, accept comments online or via e-mail. Agencies publish detailed instructions with each notice and are required to list the name and phone number of a person to contact for further information.
Once an agency publishes the final rule in the Register, they must address the significant issues raised in comments and discuss any changes made in response. It is possible FDA will not make any changes, but they are required to address the comments in their justification. In other words, the notice and comment period is almost a direct line to the agency about how the proposed rule affects you, your industry, and/or your community.
How to Submit a Public Comment Online
Federal agencies accept comments in a variety of ways, including via hearings, mail, and online. This section will detail how to submit a comment online. There are two websites you can use: www.federalregister.gov or www.regulations.gov. Comments left on both websites are recorded and reviewed by the same officials, but there are some slight differences when using them.
Both provide detailed information on the proposed rule or change and the agency’s reasons for wanting to change it. Regulations.gov is a more modern-looking site, but on Federalregister.gov you’ll be able to read all the public comments which have been submitted. For example, when this blog post was written, only three comments were visible on Regulations.gov while over 1800 were available on Federalregister.gov.
On both sites, you can find the rule by searching for it in the search bar. You will need to know the name of the proposed rule or an identifying number, such as the Federal Register Number. Click within the search results to open the call for comments.
On FederalRegister.gov, there is a green box that says, “Submit a formal comment.” This opens a box actually powered by Regulations.gov and will ask for your comment and organization name (which you can list as “private” if you want). On Regulations.gov, there is a dark blue “Comment now!” button which opens a page asking for your comment and allowing for file uploads, such as a graph or other illustration of your comment.
On both sites, you’ll be asked to select your category from a drop-down list, which varies based on the rule. For this rule, the categories include academia, animal feed group, food industry, individual consumer, private industry, and several others. Your name and contact information are not required on either site. If you choose to provide that information, it may be publicly viewable; yet another way the Register is like the YouTube comments section – though with no emojis or “Like” button as on YouTube.
Both sites also provide a link to the “Commenter’s Checklist,” a short guide with tips on how to write an effective comment. Among other things, the checklist notes that a single well-supported, thoughtful comment may be more influential than thousands of form letters, since a public comment is not the same thing as a vote.
Once you’ve completed your comment, simply hit submit and it will be recorded. And just like that, you’ll have participated in the federal rulemaking process.
For more information about the Food Safety Modernization Act and about the Produce Safety Rule visit www.umaglaw.org.