February 10, 2017

The Honorable Dominic J. Mancini

RE: Interim Guidance Implementing Section 2 of the Executive Order 13771 of January 30, 2017,
Titled Reducing Regulation and Controlling Regulatory Costs

Dear Acting Administrator Mancini,

We jointly submit this comment letter on the interim guidance in order to reinforce the
importance of deregulatory efforts in reducing regulatory burdens. Often, a full repeal of regulations
that create burdens for business is not what is necessary in order to take critical, effective action to
reduce regulations. Simply revising regulations to make them reasonable can be as effective (or more
effective) as repealing them. We urge you to recognize that in the guidance and give agencies the same
recognition for revising overly burdensome regulations as they are given for repealing overly
burdensome regulations.

In fact, when regulations have been promulgated due to legislative mandates, revision rather
than repeal may be the only option for an agency within the confines of the legal constraints of the
Administrative Procedure Act. When an overly burdensome regulation has been instituted because
legislation required a regulation to be written, repeal often is not possible without a repeal of the
legislation. But revisions are possible and it is often the case that regulations have been written
expansively when the legislation that passed did not require such expansive, burdensome
interpretations.

One primary example of the need for a revised regulation in an area where regulation was
required by legislation are the burdens placed on businesses that sell food requiring calorie and other
nutrition disclosures (commonly referred as FDA Final Menu Labeling Rule). When the Affordable
Care Act was making its way through Congress, a separate bill requiring that restaurants disclose the
calorie counts of the food they sell on menus was attached to it.

Our members agree with the goal of providing calorie counts and we are not advocating for an
exemption from providing calorie counts to our customers. The problem is that the Food and Drug
Administration (FDA) has written a rule to implement this law that does not make sense, will not get
consumers the information they need, and will dramatically and gratuitously burden businesses
throughout the nation. For years, we have advocated for bipartisan legislation to correct these
problems with FDAs rule and provide businesses with the flexibility they need to make calorie
disclosures workable. In the Congress that just ended, that bill, the Common Sense Nutrition Disclosure
Act (CSNDA), passed the House with a bipartisan vote of 266-144. We were proud to see the bill earn
the support of nearly every Republican in the House along with more than 30 Democrats.

Congress has also acted through the last couple of appropriations cycles to delay the rule to give
members more time to pass legislation to make the rule more workable without harming businesses in
the meantime. Unfortunately, CSNDA did not move through the Senate before the end of the year and
FDA to date has refused every opportunity to fix this rule, which is scheduled to go into effect May 5,
2017.

The May 5 date presents businesses with an immediate problem. In order to do all the work
that is necessary to come into compliance by May 5, they need to start spending funds to do that work
now. Indeed, the state of California has already attempted to jumpstart enforcement.

This rule is emblematic of the type of situation in which revising a rule to reduce regulatory
burdens is the ideal outcome in part because a repeal would run afoul of the legislation putting these
requirements in place.

With that in mind, FDA should make changes to the menu labeling rules as soon as possible after
taking office. To get this done right and avoid negative consequences for business, the process laid out
below could be followed to address this burdensome regulation.

FDA should publish a notice in the Federal Register immediately delaying the menu
labeling rules effective date and compliance date for 120 days. FDA has good cause for
doing this without seeking public comment first because, in light of the rapidly
approaching compliance date it would be impracticable, unnecessary, and contrary to
the public interest to seek comments before the delay. Congress and FDA already have
delayed the rule on multiple occasions and the current regulatory record demonstrates
that the rule: is inconsistent with statutory language; contains conflicting and arbitrary
requirements regarding the placement of menus and the treatment of foods sold at less
than the statutes 20-location threshold; would not provide retailers with different
business models with sufficient flexibility to provide meaningful nutrition information to
consumers; lacks flexibility with regard to how calorie counts are presented; and would
impose penalties for non-compliance (including potential criminal penalties) that are out
of proportion to the rules violations at issue.
 At the same time, FDA should solicit comments on whether it should withdraw (or stay)
and rewrite the rule. A withdrawal (or stay) of the rule is necessary to avoid a chaotic
situation in the states. If the rule is left in place or allowed to take effect during the
rewriting process (even if FDA does not enforce it), states such as California are poised
to enforce identical rules. Only a withdrawal (or stay of its effective date) will prevent
the harms of this overly burdensome rule. FDA should request comments within 30
days on whether the rule raises significant policy and legal issues and whether and how
FDA should rewrite the rule. FDA has plenty of support for this proposal given the
numerous concerns (as noted above) that have already been raised in comments on the
rule.

Following the 30-day comment period, FDA should review all comments it has received
relating to the proposal and, if it determines that the rule should be withdrawn (or
stayed) and rewritten (which we are confident it will), it should issue a notice formally
withdrawing the rule (and all related agency guidance documents) or staying it. Along
with that, FDA should publish an advanced notice of proposed rulemaking announcing
its intention to rewrite the rule and soliciting additional comment on that process.

This type of process could be used for a wide variety of regulations that were required to be
written by legislation but were written in a way that was overly burdensome. We urge you to ensure
that the guidance recognizes the value of this type of deregulatory process through revising regulations.

The FDA Menu Labeling Rule was deemed economically significant under E.O.12866 and to
trigger White House directives for review and revision under Regulatory Freeze Pending Review1,
Reducing Regulations and Controlling Costs2, and Executive Order Minimizing Economic Burden of the
Affordable Care Act3. In addition, estimated burdens may be found through a 2011 OMB Report4, a
report from the American Action Forum5 and an FMI supermarket industry6 report (which estimates that
the rule will require $1 billion in compliance costs).

As a result, we believe the FDA Menu Labeling Rule should qualify as a rule to be revised in
Section 2 of Executive Order 13771. Since the Rule has set a May 5, 2017, compliance date, and less
costly methods are readily available, a revised rule would qualify for regulatory savings in 2017.

1
https://www.whitehouse.gov/the-press-office/2017/01/20/memorandum-heads-executive-departments-and-
agencies
2
https://www.whitehouse.gov/the-press-office/2017/01/30/presidential-executive-order-reducing-regulation-
and-controlling
3
https://www.whitehouse.gov/the-press-office/2017/01/2/executive-order-minimizing-economic-burden-patient-
protection-and
4
https://obamawhitehouse.archives.gov/sites/default/files/omb/inforeg/icb/2011_icb.pdf
5
https://www.americanactionforum.org/regulation-review/final-aca-calorie-labeling-rules/
6
http://www.fmi.org/docs/newsletters-comments/omb-menu-labeling---omb-review-pursuant-to-executive-
order-12866-and-13563.pdf?sfvrsn=0
 Our member businesses and their customers need your help to ensure common sense prevails.
We hope the guidance fully reflects the value of this type of action and that FDA quickly takes these
actions to reduce the burdens of its menu labeling rule.

Sincerely,

Food Marketing Institute (FMI)