Dec. 4, 2020

James Lawrence
Department of Health and Human Services 200 Independence Avenue SW Washington, DC 20201

Re: Request for Withdrawal or Extension: Proposed Rule, Securing Updated and Necessary Statutory Evaluations Timely [sic] (Docket No. HHS-OS-2020-0012)

Dear Mr. Lawrence,

The undersigned food industry and consumer organizations respectfully urge the U.S. Department of Health and Human Services (“HHS” or “the Department”) to immediately withdraw the proposed rule entitled “Securing Updated and Necessary Statutory Evaluations Timely” [sic], Docket No. HHS-OS-2020-0012 (“Proposed Rule”) for the reasons outlined below.

Should the proposal not be withdrawn, the undersigned respectfully request that HHS immediately extend the deadline for submission of comments for an additional 180 days from December 4, 2020 to June 2, 2021, or, at the very minimum, for at least 60 days, to provide stakeholders with sufficient time to submit comments. Executive Order 12866 advises that agencies should generally provide, at a minimum, at least sixty days for public comment.

The issues raised by this proposal are inarguably complex. If finalized, the proposal would automatically sunset regulations if not reviewed within two years. Such a sweeping proposal is inappropriate for HHS to consider completing in the rushed manner proposed, given its wide-ranging implications and the coming Presidential transition, as well as the draw it would impose on HHS during the current pandemic. Saving lives should be the focus of the Department’s resources and attention at this critical time.

HHS Chief of Staff Brian Harrison indicated in official statements that this proposal is “the boldest and most significant regulatory reform effort ever undertaken by HHS.” Indeed, it would affect thousands of regulations across HHS, its subagencies, and its programs. These rules cover fundamental food safety rules, food labeling and transparency, as well as Medicare and Medicaid provision, among many other topics. The proposal thus implicates expansive industry and public interests and must be approached with the deliberateness and care that such a significant regulatory reform would require.

Prudent retrospective review of regulations is an important undertaking. However, as currently set forth, the Proposed Rule is poorly conceived and legally suspect, as it fails to include notice-and-comment on the rescission of rules and the rescissions could conflict with statutory obligations. It also fails to address concerns about its implementation, costs, and consequent administrative burden and lacks clear or tangible benefits to public health.

First, creating a system to automatically sunset thousands of regulations across HHS unless they are justified anew would impose crippling and pointless administrative burdens. Upon completion of this rule, the Department would need to review more than 2,400 regulations within two years to prevent regulations from expiring. The costs of such an undertaking would also be high for stakeholders, and especially burdensome for smaller entities, as the rule would create massive and profound new uncertainties about regulatory and compliance obligations going forward.

Moreover, conducting such a review (except in the most cursory manner) would be, practically speaking, impossible, and therefore likely to sunset rules by default that are both sound and necessary. The result is likely to be a chaotic process whereby which rules are rescinded would be as much the result of random bureaucratic processes as it would of deep consideration.

Second, this approach is far too unwieldy and costly. In total, the Department estimates the proposed rule will cost the agency $10 million to $25 million–one to two million dollars per year–and involve almost 100 full-time employees over 10 years. Precious agency resources would be wasted on review of time-tested science-backed regulations for which there is no needed review, rather than proceeding in a targeted manner to identify and amend or withdraw regulations that no longer serve a purpose.

Moreover, there exist many alternative, and more efficient, ways of securing the same end. Regulatory reviews of specific rules can be prompted at any time by departments or agencies as part of annual regulatory planning, via citizen petitions, by a cross-cutting process such as occurred at the beginning of the current administration, or on an as-needed basis.

Rushing to finalize a rule with such obvious legal and administrative issues is ill-advised. HHS has more than enough to do to address the pandemic and other serious concerns. In sum, this needless proposed rule should be withdrawn or, at a minimum, HHS should provide for an extension of the comment period.

Thank you for your consideration.


Action for Healthy Kids (AFHK)
American College of Nurse-Midwives
American Frozen Food Institute
Antibiotic Resistance Action Center, George Washington University
Association of SNAP Nutrition Education Administrators (ASNNA)
Center for Auto Safety
Center for Biological Diversity Center for Food Safety
Center for Science in the Public Interest
ChangeLab Solutions
Chef Ann Foundation
Connecticut General Assembly Commission on Women, Children, Seniors, Equity & Opportunity
Consumer Brands Association
Consumer Federation of America Consumer Reports
Corn Refiners Association
Food & Water Watch
Food Animal Concerns Trust
Government Accountability Project
Government Information Watch
Jacobs Institute of Women’s Health
John Hopkins Center for a Livable Future
Kids and Cars
National Confectioners Association
National Consumer Voice for Quality Long-Term Care
National Consumers League
National Employment Law Project
National Nurses United
National WIC Association
Network of Jewish Human Service Agencies
North American Meat Institute
Nourish Colorado
Open Hand Atlanta
Public Health Advocates
Service Employees International Union
Stop Foodborne Illness
United Fresh Produce Association