[House Report 117-538]
[From the U.S. Government Publishing Office]


117th Congress    }                                     {       Report
                        HOUSE OF REPRESENTATIVES
 2d Session       }                                     {      117-538

======================================================================

 
   RESOLUTION OF INQUIRY DIRECTING THE PRESIDENT TO PROVIDE CERTAIN 
DOCUMENTS IN THE PRESIDENT'S POSSESSION TO THE HOUSE OF REPRESENTATIVES 
    RELATING TO THE RECALL OF INFANT FORMULA MANUFACTURED BY ABBOTT 
 LABORATORIES AND POTENTIAL IMPACTS ON THE INFANT FORMULA SUPPLY CHAIN

                                _______
                                

 September 30, 2022.--Referred to the House Calendar and ordered to be 
                                printed

                                _______
                                

 Mr. Pallone, from the Committee on Energy and Commerce, submitted the 
                               following

                              R E P O R T

                      [To accompany H. Res. 1287]

    The Committee on Energy and Commerce, to whom was referred 
the resolution (H. Res. 1287) of inquiry directing the 
President to provide certain documents in the President's 
possession to the House of Representatives relating to the 
recall of infant formula manufactured by Abbott Laboratories 
and potential impacts on the infant formula supply chain, 
having considered the same, reports favorably thereon without 
amendment and recommends that the resolution be agreed to.

                                CONTENTS

                                                                     Page
  I. Purpose and Summary..............................................  1
 II. Background and Need for the Legislation..........................  2
III. Committee Hearings...............................................  3
 IV. Committee Consideration..........................................  3
  V. Committee Votes..................................................  3
 VI. Oversight Findings...............................................  5
VII. New Budget Authority, Entitlement Authority, and Tax Expenditures  5
VIII.Federal Mandates Statement.......................................  5

 IX. Statement of General Performance Goals and Objectives............  5
  X. Duplication of Federal Programs..................................  5
 XI. Committee Cost Estimate..........................................  5
XII. Earmarks, Limited Tax Benefits, and Limited Tariff Benefits......  5
XIII.Advisory Committee Statement.....................................  6 
XIV. Applicability to Legislative Branch..............................  6
 XV. Section-by-Section Analysis of the Legislation...................  6
XVI. Changes in Existing Law Made by the Bill, as Reported............  6

                         I. PURPOSE AND SUMMARY

    H. Res. 1287 directs the President to provide certain 
documents in the President's possession to the House of 
Representatives relating to the recall of infant formula 
manufactured by Abbott Laboratories and potential impacts on 
the infant formula supply chain.

                II. BACKGROUND AND NEED FOR LEGISLATION

    In January 2022, reports of a shortage of infant formula 
began due to coronavirus disease of 2019 (COVID-19) pandemic-
related supply chain challenges.\1\ This shortage was 
exacerbated in February 2022 by a voluntary recall of certain 
brands of powdered infant formula manufactured by Abbott 
Nutrition following reports of potential Cronobacter sakazakii 
contamination at Abbott Nutrition's Sturgis, Michigan 
facility.\2\ As many as 75 percent of American caregivers 
partially depend on formula to provide nutrients to their 
infants up to six-months of age.\3\
---------------------------------------------------------------------------
    \1\Baby Formula is Hard to Find. Brands and Stores Are Divided Over 
Why, Wall Street Journal (Jan. 12, 2022).
    \2\Why is There a Baby-Formula Shortage? What to Know and What's 
Being Done About It, Wall Street Journal (May 12, 2022); Baby Formula 
Recalled by Abbott After Reports of Bacterial Contamination, Wall 
Street Journal (Feb. 18, 2022).
    \3\U.S. Baby Formula Shortage is Worrying Parents. Here's What to 
Know, Washington Post (May 11, 2022).
---------------------------------------------------------------------------
    On May 25, 2022, the Committee on Energy and Commerce 
Subcommittee on Oversight and Investigations held a hearing 
entitled, ``Formula Safety and Supply: Protecting the Health of 
America's Babies.'' Food and Drug Administration (FDA) 
Commissioner Robert Califf's testimony referenced memos sent to 
the White House describing the formula shortage issues. After 
the hearing, Chairman Pallone and Ranking Member Rodgers 
requested copies of these memos which have yet to be provided 
to the Committee.
    This resolution seeks to obtain these memos and other 
documentation relating to the recall of infant formula 
manufactured by Abbott Laboratories and the subsequent impacts 
on the infant formula supply chain in the United States. A 
coordinated federal response to infant formula supply 
vulnerabilities--including formation of an FDA Incident 
Management Group and issuance of FDA enforcement discretion 
guidance--began as shortages reached crisis levels in Spring 
2022.\4\\5\ The Administration has since taken critical steps 
to improve families' access to infant formula, including 
invoking the Defense Production Act, expediting importation, 
launching distribution efforts to communities particularly 
impacted by the shortage, cracking down on price gouging scams, 
and coordinating with manufacturers and retailers to boost 
supply.\6\ However, it is part of this Committee's role to 
conduct oversight and ensure that we have both a robust food 
safety program and a reliable supply of vital food products, 
and the Committee has not been able to fully discharge that 
responsibility through its oversight. For this reason, the 
Committee ordered H. Res. 1287 to the House favorably.
---------------------------------------------------------------------------
    \4\Food and Drug Admin., FDA Takes Important Steps to Improve 
Supply of Infant and Specialty Formula Products (https://www.fda.gov/
news-events/press-announcements/fda-takes-
important-steps-improve-supply-infant-and-specialty-formula-products) 
(May 10, 2022).
    \5\Food and Drug Admin., Guidance for Industry: Infant Formula 
Enforcement Discretion Policy (https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/guidance-industry-infant-
formula-enforcement-discretion-policy) (May 18, 2022).
    \6\The White House, Addressing the Infant Formula Shortage (https:/
/www.whitehouse.gov/
formula/).
---------------------------------------------------------------------------

                        III. COMMITTEE HEARINGS

    The Committee on Energy and Commerce has not held hearings 
on H. Res. 1287.

                      IV. COMMITTEE CONSIDERATION

    H. Res. 1287 was introduced on July 26, 2022, by 
Representative Walberg (R-MI) and was referred to the Committee 
on Energy and Commerce. Subsequently, on July 27, 2022, the 
resolution was referred to the Subcommittee on Health. The 
resolution was discharged from the Subcommittee on Health on 
September 21, 2022.
    On September 21, 2022, the Committee met in open markup 
session and ordered H. Res. 1287, without amendment, favorably 
reported to the House by a record vote of 56 yeas and zero 
nays.

                           V. COMMITTEE VOTES

    Clause 3(b) of rule XIII of the Rules of the House of 
Representatives requires the Committee to list each record vote 
on the motion to report legislation and amendments thereto. The 
Committee advises that there was one record vote taken on H. 
Res. 1287, including a motion by Mr. Pallone ordering H. Res. 
1287 favorably reported to the House, without amendment. The 
motion on final passage of the bill was approved by a record 
vote of 56 yeas to zero nays. The following are the record 
votes taken during Committee consideration, including the names 
of those members voting for and against:

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


                         VI. OVERSIGHT FINDINGS

    Pursuant to clause 3(c)(1) of rule XIII and clause 2(b)(1) 
of rule X of the Rules of the House of Representatives, the 
oversight findings and recommendations of the Committee are 
reflected in the descriptive portion of the report.

 VII. NEW BUDGET AUTHORITY, ENTITLEMENT AUTHORITY, AND TAX EXPENDITURES

    Pursuant to 3(c)(2) of rule XIII of the Rules of the House 
of Representatives, the Committee adopts as its own the 
estimate of new budget authority, entitlement authority, or tax 
expenditures or revenues contained in the cost estimate 
prepared by the Director of the Congressional Budget Office 
pursuant to section 402 of the Congressional Budget Act of 
1974.
    The Committee has requested but not received from the 
Director of the Congressional Budget Office a statement as to 
whether this bill contains any new budget authority, spending 
authority, credit authority, or an increase or decrease in 
revenues or tax expenditures.

                    VIII. FEDERAL MANDATES STATEMENT

    The Committee adopts as its own the estimate of Federal 
mandates prepared by the Director of the Congressional Budget 
Office pursuant to section 423 of the Unfunded Mandates Reform 
Act.

       IX. STATEMENT OF GENERAL PERFORMANCE GOALS AND OBJECTIVES

    Pursuant to clause 3(c)(4) of rule XIII, the general 
performance goal or objective of this legislation is to direct 
the President to provide certain documents in the President's 
possession to the House of Representatives relating to the 
recall of infant formula manufactured by Abbott Laboratories 
and potential impacts on the infant formula supply chain.

                   X. DUPLICATION OF FEDERAL PROGRAMS

    Pursuant to clause 3(c)(5) of rule XIII, no provision of H. 
Res. 1287 is known to be duplicative of another Federal 
program, including any program that was included in a report to 
Congress pursuant to section 21 of Public Law 111-139 or the 
most recent Catalog of Federal Domestic Assistance.

                      XI. COMMITTEE COST ESTIMATE

    Pursuant to clause 3(d)(1) of rule XIII, the Committee 
adopts as its own the cost estimate prepared by the Director of 
the Congressional Budget Office pursuant to section 402 of the 
Congressional Budget Act of 1974.

    XII. EARMARKS, LIMITED TAX BENEFITS, AND LIMITED TARIFF BENEFITS

    Pursuant to clause 9(e), 9(f), and 9(g) of rule XXI, the 
Committee finds that H. Res. 1287 contains no earmarks, limited 
tax benefits, or limited tariff benefits.

                   XIII. ADVISORY COMMITTEE STATEMENT

    No advisory committee within the meaning of section 5(b) of 
the Federal Advisory Committee Act was created by this 
legislation.

                XIV. APPLICABILITY TO LEGISLATIVE BRANCH

    The Committee finds that the legislation does not relate to 
the terms and conditions of employment or access to public 
services or accommodations within the meaning of section 
102(b)(3) of the Congressional Accountability Act.

           XV. SECTION-BY-SECTION ANALYSIS OF THE LEGISLATION

    H. Res. 1287 directs the President to furnish copies of any 
document or record, audio recording, memorandum, call log, 
correspondence, or other communication in the President's 
possession referring or relating to (1) the memoranda and 
report referenced by Dr. Califf, FDA Commissioner, related to 
infant formula recall at the May 25, 2022, hearing of the 
Subcommittee on Oversight and Investigations; (2) all 
communications between the Commissioner and other FDA staff 
related to infant formula recall prior to February 2022; (3) 
the failure of FDA to ensure the whistleblower complaint 
submitted to the agency by an employee of Abbott Laboratories 
was sent to all necessary and appropriate officials and what 
actions FDA has taken to prevent such a failure from happening 
in the future; (4) the number of full-time equivalent positions 
in the FDA Office of Regulatory Affairs that remain vacant for 
food safety compliance and inspection staff; (5) all 
communications between FDA and the Department of Agriculture 
about the recall of infant formula manufactured by Abbott 
Laboratories and the potential impact on the Special 
Supplemental Nutrition Program for Women, Infants, and Children 
(WIC), including the timing of such communications; and (6) the 
number of submissions pending at FDA as of the date of the 
adoption of the resolution for the marketing of infant formula, 
delineated by domestic and foreign manufacturers.

       XVI. CHANGES IN EXISTING LAW MADE BY THE BILL, AS REPORTED

    There are no changes to existing law made by the bill H. 
Res. 1287.

                                  [all]