I 
108TH CONGRESS 
1ST SESSION 
H. R. 663
To amend title IX of the Public Health Service Act to provide for the 
improvement of patient safety and to reduce the incidence of events 
that adversely affect patient safety, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
FEBRUARY 11, 2003
Mr. BILIRAKIS (for himself, Mr. BROWN of Ohio, Mr. TAUZIN, Mr. DINGELL, 
Mr. BARTON of Texas, Mr. WAXMAN, Mr. UPTON, Mr. MARKEY, Mr. 
GREENWOOD, Mr. TOWNS, Mr. BURR, Mr. PALLONE, Mr. WHITFIELD, 
Mr. GORDON, Mr. NORWOOD, Mr. DEUTSCH, Mr. TERRY, Mr. RUSH, Mr. 
ROGERS of Michigan, Mr. ENGEL, Mr. WYNN, Ms. MCCARTHY of Mis-
souri, Mr. STRICKLAND, Mrs. CAPPS, Mr. JOHN, and Ms. HARMAN) in-
troduced the following bill; which was referred to the Committee on En-
ergy and Commerce 
A BILL 
To amend title IX of the Public Health Service Act to 
provide for the improvement of patient safety and to 
reduce the incidence of events that adversely affect pa-
tient safety, and for other purposes.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Patient Safety and 
Quality Improvement Act’’.
SEC. 2. FINDINGS AND PURPOSES. 
(a) FINDINGS.—The Congress finds as follows: 
(1) In 1999, the Institute of Medicine released 
a report entitled ‘‘To Err Is Human’’ that described 
medical errors as the 8th leading cause of death in 
the United States, with as many as 98,000 people 
dying as a result of medical errors each year. 
(2) To address these deaths and injuries due to 
medical errors, the health care system must identify 
and learn from such errors so that systems of care 
can be improved. 
(3) Myriad public and private patient safety ini-
tiatives have begun. The Quality Interagency Coordi-
nation Task Force has recommended steps to im-
prove patient safety that may be taken by each Fed-
eral agency involved in health care and activities re-
lating to these steps are ongoing. 
(4) The Department of Health and Human 
Services has initiated several patient safety projects. 
The 
Joint 
Commission 
on 
Accreditation 
of 
Healthcare Organizations issued a patient safety 
standard that went into effect on July 1, 2001, and 
the peer review organizations are conducting ongoing 
studies of clinical performance measurement of care 
delivered to beneficiaries under the medicare pro-
gram under title XVIII of the Social Security Act.
(5) Several steps can be taken now to improve 
patient safety. For example, according to the Cen-
ters for Disease Control and Prevention, hand wash-
ing is the single most important means of preventing 
the spread of infection. Repeated studies indicate 
that lack of or improper hand washing still contrib-
utes significantly to disease transmission in health 
care settings. Working with experts from the private 
sector, the Centers for Disease Control and Preven-
tion has drafted ‘‘Guidelines for Hand Hygiene in 
Healthcare Settings’’ setting forth recommendations 
to promote improved hand hygiene practices and re-
duce transmission of pathogenic microorganisms to 
patients and personnel in health care settings. 
(6) According to the Centers for Disease Con-
trol and Prevention, nosocomial infections affect ap-
proximately 2 million patients annually in acute care 
facilities in the United States at an estimated direct 
patient care cost of approximately $3.5 billion each 
year. 
(7) The Congress encourages the continuation 
and acceleration of private sector efforts to take im-
mediate steps to improve patient safety and recog-
nizes the need for action in the public sector to com-
plement these efforts.
(8) The research on patient safety unequivo-
cally calls for a learning environment, where pro-
viders will feel safe to report health care errors, in 
order to improve patient safety. 
(9) Voluntary data gathering systems are more 
supportive than mandatory systems in creating the 
learning environment referred to in paragraph (8) as 
stated in the Institute of Medicine’s report. 
(10) Promising patient safety reporting systems 
have been established throughout the United States, 
and the best ways to structure and use these sys-
tems are currently being determined, largely through 
projects funded by the Agency for Healthcare Re-
search and Quality. 
(11) Many organizations currently collecting 
patient safety information have expressed a need for 
protections that will allow them to review protected 
information so that they may collaborate in the de-
velopment and implementation of patient safety im-
provement strategies. Currently, the State peer re-
view protections provide inadequate conditions to 
allow the sharing of information to promote patient 
safety. 
(12) In 2001, the Institute of Medicine released 
a report entitled ‘‘Crossing the Quality Chasm’’ that
found that the United States health care system 
does not consistently deliver high-quality care to pa-
tients. 
(b) PURPOSES.—The purposes of this Act are—
(1) to encourage a culture of safety and quality 
in the United States health care system by providing 
for a health care errors reporting system that both 
protects information and improves patient safety 
and quality of health care; and 
(2) to ensure accountability by raising stand-
ards and expectations for continuous quality im-
provements in patient safety through the actions of 
the Secretary of Health and Human Services. 
SEC. 3. AMENDMENTS TO PUBLIC HEALTH SERVICE ACT. 
(a) IN GENERAL.—Title IX of the Public Health 
Service Act (42 U.S.C. 299 et seq.) is amended—
(1) in section 912(c), by inserting ‘‘, in accord-
ance with part C,’’ after ‘‘The Director shall’’; 
(2) by redesignating part C as part D; 
(3) by redesignating sections 921 through 928, 
as sections 931 through 938, respectively; 
(4) in section 938(1) (as so redesignated), by 
striking ‘‘921’’ and inserting ‘‘931’’; and 
(5) by inserting after part B the following:
‘‘PART C—PATIENT SAFETY IMPROVEMENT 
‘‘SEC. 921. DEFINITIONS. 
‘‘In this part: 
‘‘(1) IDENTIFIABLE INFORMATION.—The term 
‘identifiable information’ means information that is 
presented in a form and manner that allows the 
identification of any provider, patient, or reporter of 
patient safety work product. With respect to pa-
tients, such information includes any individually 
identifiable health information as that term is de-
fined in the regulations promulgated pursuant to 
section 264(c) of the Health Insurance Portability 
and Accountability Act of 1996 (Public Law 104–
191; 110 Stat. 2033). 
‘‘(2) NONIDENTIFIABLE
INFORMATION.—The 
term ‘nonidentifiable information’ means informa-
tion that is presented in a form and manner that 
prevents the identification of any provider, patient, 
or reporter of patient safety work product. With re-
spect to patients, such information must be de-iden-
tified consistent with the regulations promulgated 
pursuant to section 264(c) of the Health Insurance 
Portability and Accountability Act of 1996 (Public 
Law 104–191; 110 Stat. 2033). 
‘‘(3) PATIENT SAFETY EVALUATION SYSTEM.—
The term ‘patient safety evaluation system’ means a
process that involves the collection, management, or 
analysis of information for submission to or by a pa-
tient safety organization. 
‘‘(4) PATIENT
SAFETY
ORGANIZATION.—The 
term ‘patient safety organization’ means a private or 
public organization or component thereof that is cer-
tified, through a process to be determined by the 
Secretary under section 925, to perform each of the 
following activities: 
‘‘(A) The conduct, as the organization or 
component’s primary activity, of efforts to im-
prove patient safety and the quality of health 
care delivery. 
‘‘(B) The collection and analysis of patient 
safety work product that is submitted by pro-
viders. 
‘‘(C) The development and dissemination 
of evidence-based information to providers with 
respect to improving patient safety, such as rec-
ommendations, protocols, or information re-
garding best practices. 
‘‘(D) The utilization of patient safety work 
product to carry out activities limited to those 
described under this paragraph and for the pur-
poses of encouraging a culture of safety and of
providing direct feedback and assistance to pro-
viders to effectively minimize patient risk. 
‘‘(E) The maintenance of confidentiality 
with respect to identifiable information. 
‘‘(F) The provision of appropriate security 
measures with respect to patient safety work 
product. 
‘‘(G) The submission of nonidentifiable in-
formation to the Agency consistent with stand-
ards established by the Secretary under section 
923(b) for any National Patient Safety Data-
base. 
‘‘(5) PATIENT SAFETY WORK PRODUCT.—
‘‘(A) The term ‘patient safety work prod-
uct’ means any document or communication 
(including any information, report, record, 
memorandum, analysis, deliberative work, state-
ment, or root cause analysis) that—
‘‘(i) except as provided in subpara-
graph (B), is developed by a provider for 
the purpose of reporting to a patient safety 
organization, and is reported to a patient 
safety organization; 
‘‘(ii) is created by a patient safety or-
ganization; or
‘‘(iii) would reveal the deliberations or 
analytic process of a patient safety evalua-
tion system (as defined in paragraph (3)). 
‘‘(B)(i) Patient safety work product de-
scribed in subparagraph (A)(i)—
‘‘(I) does not include any separate in-
formation described in clause (ii); and 
‘‘(II) shall not be construed to include 
such separate information merely by rea-
son of inclusion of a copy of the document 
or communication involved in a submission 
to, or the fact of submission of such a copy 
to, a patient safety organization. 
‘‘(ii) Separate information described in this 
clause is a document or communication (includ-
ing a patient’s medical record or any other pa-
tient or hospital record) that is developed or 
maintained, or exists, separately from any pa-
tient safety evaluation system. 
‘‘(C) Information available from sources 
other than a patient safety work product under 
this section may be discovered or admitted in a 
civil or administrative proceeding, if discover-
able or admissible under applicable law. 
‘‘(6) PROVIDER.—The term ‘provider’ means—
‘‘(A) an individual or entity licensed or 
otherwise authorized under State law to provide 
health care services, including—
‘‘(i) a hospital, nursing facility, com-
prehensive outpatient rehabilitation facil-
ity, home health agency, and hospice pro-
gram; 
‘‘(ii) a physician, physician assistant, 
nurse practitioner, clinical nurse specialist, 
certified nurse midwife, psychologist, cer-
tified social worker, registered dietitian or 
nutrition professional, physical or occupa-
tional therapist, or other individual health 
care practitioner; 
‘‘(iii) a pharmacist; and 
‘‘(iv) a renal dialysis facility, ambula-
tory surgical center, pharmacy, physician 
or health care practitioner’s office, long-
term care facility, behavioral health resi-
dential treatment facility, clinical labora-
tory, or community health center; or 
‘‘(B) any other person or entity specified 
in regulations by the Secretary after public no-
tice and comment.
‘‘SEC. 922. PRIVILEGE FOR PATIENT SAFETY WORK PROD-
UCT. 
‘‘(a) PRIVILEGE.—Notwithstanding any other provi-
sion of law and subject to subsection (c), patient safety 
work product shall not be—
‘‘(1) subject to a civil or administrative sub-
poena or order; 
‘‘(2) subject to discovery in connection with a 
civil or administrative proceeding; 
‘‘(3) subject to disclosure pursuant to section 
552 of title 5, United States Code (commonly known 
as the Freedom of Information Act), or any other 
similar Federal or State law; 
‘‘(4) required to be admitted as evidence or oth-
erwise disclosed in any State or Federal civil or ad-
ministrative proceeding; or 
‘‘(5) if the patient safety work product is identi-
fiable information and is received by a national ac-
creditation organization in its capacity as a patient 
safety organization—
‘‘(A) used by a national accreditation orga-
nization in an accreditation action against the 
provider that reported the information; 
‘‘(B) shared by such organization with its 
survey team; or
‘‘(C) required as a condition of accredita-
tion by a national accreditation association. 
‘‘(b) REPORTER PROTECTION.—
‘‘(1) IN
GENERAL.—A provider may not use 
against an individual in an adverse employment ac-
tion described in paragraph (2) the fact that the in-
dividual in good faith reported information—
‘‘(A) to the provider with the intention of 
having the information reported to a patient 
safety organization; or 
‘‘(B) directly to a patient safety organiza-
tion. 
‘‘(2) ADVERSE
EMPLOYMENT
ACTION.—For 
purposes of this subsection, an ‘adverse employment 
action’ includes—
‘‘(A) the failure to promote an individual 
or provide any other employment-related benefit 
for which the individual would otherwise be eli-
gible; 
‘‘(B) an adverse evaluation or decision 
made in relation to accreditation, certification, 
credentialing, or licensing of the individual; and 
‘‘(C) a personnel action that is adverse to 
the individual concerned.
‘‘(3) REMEDIES.—Any provider that violates 
this subsection shall be subject to a civil monetary 
penalty of not more than $20,000 for each such vio-
lation involved. Such penalty shall be imposed and 
collected in the same manner as civil money pen-
alties under subsection (a) of section 1128A of the 
Social Security Act are imposed and collected. 
‘‘(c) DISCLOSURES.—Nothing in this section pro-
hibits any of the following disclosures: 
‘‘(1) Voluntary disclosure of nonidentifiable in-
formation. 
‘‘(2) Voluntary disclosure of identifiable infor-
mation by a provider or patient safety organization, 
if such disclosure—
‘‘(A) is authorized by the provider for the 
purposes of improving quality and safety; 
‘‘(B) is to an entity or person subject to 
the requirements of section 264(c) of the 
Health Insurance Portability and Accountability 
Act of 1996 (Public Law 104–191; 110 Stat. 
2033), or any regulation promulgated under 
such section; and 
‘‘(C) is not in conflict with such section or 
any regulation promulgated under such section.
work product in violation of this section, if such dis-
closure constitutes a negligent or knowing breach of 
confidentiality. 
‘‘(2) RELATION
TO
HIPAA.—The penalty 
under paragraph (3) for a disclosure in violation of 
paragraph (1) does not apply if the person would be 
subject to a penalty under section 264(c) of the 
Health Insurance Portability and Accountability Act 
of 1996 (Public Law 104–191; 110 Stat. 2033), or 
any regulation promulgated under such section, for 
the same disclosure. 
‘‘(3) AMOUNT.—Any person who violates para-
graph (1) shall be subject to a civil monetary penalty 
of not more than $10,000 for each such violation in-
volved. Such penalty shall be imposed and collected 
in the same manner as civil money penalties under 
subsection (a) of section 1128A of the Social Secu-
rity Act are imposed and collected. 
‘‘(4) SUBSEQUENT
DISCLOSURE.—Paragraph 
(1) applies only to the first person that breaches 
confidentiality with respect to particular patient 
safety work product. 
‘‘(f) RELATION TO HIPAA.—
‘‘(1) IN GENERAL.—For purposes of applying 
the regulations promulgated pursuant to section
264(c) of the Health Insurance Portability and Ac-
countability Act of 1996 (Public Law 104–191; 110 
Stat. 2033)—
‘‘(A) patient safety organizations shall be 
treated as business associates; and 
‘‘(B) activities of such organizations de-
scribed in section 921(4) in relation to a pro-
vider are deemed to be health care operations 
(as defined in such regulations) of the provider. 
‘‘(2) RULE
OF
CONSTRUCTION.—Nothing in 
this section shall be construed to alter or affect the 
implementation of such regulations or such section 
264(c). 
‘‘(g) NO LIMITATION
OF OTHER PRIVILEGES.—
Nothing in this section shall be construed to affect privi-
leges, including peer review and confidentiality protec-
tions, that are otherwise available under Federal or State 
laws. 
‘‘(h) NO LIMITATION ON CONTRACTS.—Nothing in 
this section shall be construed to limit the power of a pro-
vider and a patient safety organization, or a patient safety 
organization and the Agency or any National Patient 
Safety Database, consistent with the provisions of this Act 
and other applicable law, to enter into a contract requiring
greater confidentiality or delegating authority to make an 
authorized disclosure. 
‘‘(i) RELATION
TO STATE REPORTING REQUIRE-
MENTS.—Nothing in this part shall be construed as pre-
empting or otherwise affecting any State law requiring a 
provider to report information, including information de-
scribed in section 921(5)(B), that is not patient safety 
work product. 
‘‘(j) CONTINUATION OF PRIVILEGE.—Patient safety 
work product of an organization that is certified as a pa-
tient safety organization shall continue to be privileged 
and confidential, in accordance with this section, if the or-
ganization’s certification is terminated or revoked or if the 
organization otherwise ceases to qualify as a patient safety 
organization. 
‘‘(k) REPORTS ON STRATEGIES TO IMPROVE PA-
TIENT SAFETY.—
‘‘(1) DRAFT REPORT.—Not later than the date 
that is 18 months after any National Patient Safety 
Database is operational, the Secretary, in consulta-
tion with the Director, shall prepare a draft report 
on effective strategies for reducing medical errors 
and increasing patient safety. The draft report shall 
include any measure determined appropriate by the 
Secretary to encourage the appropriate use of such
strategies, including use in any federally funded pro-
grams. The Secretary shall make the draft report 
available for public comment and submit the draft 
report to the Institute of Medicine for review. 
‘‘(2) FINAL REPORT.—Not later than 1 year 
after the date described in paragraph (1), the Sec-
retary shall submit a final report to the Congress 
that includes, in an appendix, any findings by the 
Institute of Medicine concerning research on the 
strategies discussed in the draft report and any 
modifications made by the Secretary based on such 
findings. 
‘‘SEC. 923. NATIONAL DATABASE. 
‘‘(a) AUTHORITY.—
‘‘(1) IN
GENERAL.—In conducting activities 
under this part, the Secretary shall provide for the 
establishment and maintenance of a database to re-
ceive relevant nonidentifiable patient safety work 
product, and may designate entities to collect rel-
evant nonidentifiable patient safety work product 
that is voluntarily reported by patient safety organi-
zations upon the request of the Secretary. Any data-
base established or designated under this paragraph 
may be referred to as a ‘National Patient Safety 
Database’.
‘‘(2) USE OF INFORMATION.—Information re-
ported to any National Patient Safety Database 
shall be used to analyze national and regional statis-
tics, including trends and patterns of health care er-
rors. The information resulting from such analyses 
may be included in the annual quality reports pre-
pared under section 913(b)(2). 
‘‘(3) ADVISORY
ROLE.—The Secretary shall 
provide scientific support to patient safety organiza-
tions, including the dissemination of methodologies 
and evidence-based information related to root 
causes and quality improvement. 
‘‘(b) STANDARDS.—In establishing or designating a 
database under subsection (a)(1), the Secretary shall, in 
consultation with representatives of patient safety organi-
zations, the provider community, and the health informa-
tion technology industry, determine common formats for 
the voluntary reporting of nonidentifiable patient safety 
work product, including necessary elements, common and 
consistent definitions, and a standardized computer inter-
face for the processing of the work product. To the extent 
practicable, such standards shall be consistent with the 
administrative simplification provisions of part C of title 
XI of the Social Security Act.
‘‘(c) CERTAIN METHODOLOGIES FOR COLLECTION.—
The Secretary shall ensure that the methodologies for the 
collection of nonidentifiable patient safety work product 
for any National Patient Safety Database include the 
methodologies developed or recommended by the Patient 
Safety Task Force of the Department of Health and 
Human Services. 
‘‘(d) FACILITATION OF INFORMATION EXCHANGE.—
To the extent practicable, the Secretary may facilitate the 
direct link of information between providers and patient 
safety organizations and between patient safety organiza-
tions and any National Patient Safety Database. 
‘‘(e) RESTRICTION ON TRANSFER.—Only nonidentifi-
able information may be transferred to any National Pa-
tient Safety Database. 
‘‘SEC. 924. TECHNICAL ASSISTANCE. 
‘‘(a) IN GENERAL.—The Secretary, acting through 
the Director, may—
‘‘(1) provide technical assistance to patient 
safety organizations, and to States with reporting 
systems for health care errors; and 
‘‘(2) provide guidance on the type of data to be 
voluntarily submitted to any National Patient Safety 
Database.
‘‘(b) 
ANNUAL
MEETINGS.—Assistance 
provided 
under subsection (a) may include annual meetings for pa-
tient safety organizations to discuss methodology, commu-
nication, information collection, or privacy concerns. 
‘‘SEC. 925. CERTIFICATION OF PATIENT SAFETY ORGANIZA-
TIONS. 
‘‘(a) IN GENERAL.—Not later than 6 months after 
the date of enactment of the Patient Safety and Quality 
Improvement Act, the Secretary shall establish a process 
for certifying patient safety organizations. 
‘‘(b) PROCESS.—The process established under sub-
section (a) shall include the following: 
‘‘(1) Certification of patient safety organiza-
tions by the Secretary or by such other national or 
State governmental organizations as the Secretary 
determines appropriate. 
‘‘(2) If the Secretary allows other governmental 
organizations to certify patient safety organizations 
under paragraph (1), the Secretary shall establish a 
process for approving such organizations. Any such 
approved organization shall conduct certifications 
and reviews in accordance with this section. 
‘‘(3) A review of each certification under para-
graph (1) (including a review of compliance with 
each criterion in this section and any related imple-
‘‘(3) The mission of the patient safety organiza-
tion does not create a conflict of interest with the 
rest of the organization.’’. 
(b) AUTHORIZATION OF APPROPRIATIONS.—Section 
937 of the Public Health Service Act (as redesignated by 
subsection (a)) is amended by adding at the end the fol-
lowing: 
‘‘(e) PATIENT SAFETY
AND QUALITY IMPROVE-
MENT.—For the purpose of carrying out part C, there are 
authorized to be appropriated such sums as may be nec-
essary for each of the fiscal years 2004 through 2013.’’. 
SEC. 4. PROMOTING THE DIFFUSION AND INTEROPER-
ABILITY OF INFORMATION TECHNOLOGY SYS-
TEMS INVOLVED WITH HEALTH CARE DELIV-
ERY. 
(a) VOLUNTARY STANDARDS.—
(1) IN GENERAL.—Not later than 18 months 
after the date of the enactment of this Act, the Sec-
retary of Health and Human Services (in this sec-
tion referred to as the ‘‘Secretary’’) shall—
(A) develop or adopt voluntary national 
standards that promote the interoperability of 
information technology systems involved with 
health care delivery, including but not limited to 
computerized physician order entry;
(B) in developing or adopting such stand-
ards, take into account—
(i) the ability of such systems to cap-
ture and aggregate clinically specific data 
to enable evidence-based medicine and 
other applications that promote the elec-
tronic exchange of patient medical record 
information; and 
(ii) the cost that meeting such stand-
ards would have on providing health care 
in the United States and the increased effi-
ciencies in providing such care achieved 
under the standards; 
(C) in developing or adopting such stand-
ards and to the extent practicable, test the effi-
cacy, usability, and scalability of proposed inter-
operability standards within a variety of clinical 
settings, including an urban academic medical 
center, a rural hospital, a community health 
center, and a community hospital; and 
(D) submit a report to the Congress con-
taining recommendations on such standards. 
(2) CONSULTATION.—In developing or adopting 
standards under paragraph (1)(A), the Secretary 
shall consider the recommendations of the National
Committee on Vital Health Statistics for the stand-
ardization of message formatting, coding, and vocab-
ulary for interoperability of information technology 
systems involved with health care delivery. The Sec-
retary shall consult with representatives of the 
health information technology industry and the pro-
vider community who are involved with the develop-
ment of interoperability standards. 
(b) UPDATES.—The Secretary shall provide for the 
ongoing review and periodic updating of the standards de-
veloped under subsection (a). 
SEC. 5. REQUIRED USE OF PRODUCT IDENTIFICATION 
TECHNOLOGY. 
The Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 301 et seq.) is amended—
(1) in section 502, by adding at the end the fol-
lowing: 
‘‘(w) If it is a drug or biological product, unless it 
includes a unique product identifier for the drug or bio-
logical product as required by regulations under section 
510(q).’’; and 
(2) in section 510, by adding at the end the fol-
lowing: 
‘‘(q)(1) The Secretary shall issue, and may periodi-
cally revise, regulations requiring the manufacturer of any
drug or biological product that is subject to regulation by 
the Food and Drug Administration, or the packager or 
labeler of a drug or biological product that is subject to 
regulation by the Food and Drug Administration, to in-
clude a unique product identifier on the packaging of the 
drug or biological product. 
‘‘(2) For purposes of this subsection, the term 
‘unique product identifier’ means an identification that—
‘‘(A) is affixed by the manufacturer, labeler, or 
packager to each drug or biological product de-
scribed in paragraph (1) at each packaging level; 
‘‘(B) uniquely identifies the item and meets the 
standards required by this section; and 
‘‘(C) can be read by a scanning device or other 
technology acceptable to the Secretary. 
‘‘(3) A unique product identifier required by regula-
tions issued or revised under paragraph (1) shall be based 
on—
‘‘(A) the National Drug Code maintained by 
the Food and Drug Administration; 
‘‘(B) commercially accepted standards estab-
lished by organizations that are accredited by the 
American National Standards Institute, such as the 
Health Industry Business Communication Council or 
the Uniform Code Council; or
‘‘(C) other identification formats that the Sec-
retary deems appropriate. 
‘‘(4) The Secretary may, at the Secretary’s discre-
tion, waive the requirements of this section, or add addi-
tional provisions that are necessary to safeguard the pub-
lic health.’’.
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