Federal Register / Vol. 87, No. 90 / Tuesday, May 10, 2022 / Proposed Rules 27961 

1For the purposes of this action, the WTC Health 

Program defines the term ‘‘uterine cancer’’ as ICD– 

10 code C54, including the following specific 

malignant neoplasms: Isthmus uteri (C54.0), 

endometrium (C54.1), myometrium (C54.2), fundus 

uteri (C54.3), overlapping sites of corpus uteri 

(C54.8), and corpus uteri, unspecified (C54.9); and 

ICD–10 code C55, including only a single subcategory, malignant neoplasm of uterus, part 

unspecified. 

2 Due to the implementation of the Affordable 

Care Act in 2014, and as required under the 

authorizing statute for the WTC Health Program, all 

current and future Program members are assumed 

to have or have access to medical insurance 

Continued 

Dated: May 5, 2022. 

Eric J. Velez, 

Commander, U.S. Coast Guard, Captain of 

the Port Marine Safety Unit Pittsburgh. 

[FR Doc. 2022–10024 Filed 5–9–22; 8:45 am] 

BILLING CODE 9110–04–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

42 CFR Part 88 

[Docket No. CDC–2022–0052; NIOSH–347] 

RIN 0920–AA82 

World Trade Center (WTC) Health 

Program; Addition of Uterine Cancer to 

the List of WTC-Related Health 

Conditions 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Notice of proposed rulemaking. 

SUMMARY: Title I of the James Zadroga 9/ 

11 Health and Compensation Act of 

2010 amended the Public Health Service 

Act (PHS Act) to establish the World 

Trade Center (WTC) Health Program. 

The WTC Health Program (Program), 

which is administered by the Director of 

the National Institute for Occupational 

Safety and Health (NIOSH), within CDC, 

provides medical monitoring and 

treatment to eligible responders to the 

September 11, 2001, terrorist attacks in 

New York City, at the Pentagon, and in 

Shanksville, Pennsylvania, and to 

eligible survivors of the New York City 

attacks. In accordance with the WTC 

Health Program’s regulations, which 

establish procedures for adding a new 

condition to the list of health conditions 

covered by the Program, this proposed 

rule would add malignant neoplasms of 

corpus uteri and uterus, part 

unspecified (uterine cancer) to the List 

of WTC-Related Health Conditions 

(List). 

DATES: Comments must be received by 

June 24, 2022. 

ADDRESSES: You may submit comments 

identified by Docket No. CDC–2022– 

0052 and NIOSH–347 by either of the 

following methods: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: NIOSH Docket Office, Robert 

A. Taft Laboratories, MS C–34, 1090 

Tusculum Avenue, Cincinnati, Ohio 

45226–1998. 

Instructions: All written submissions 

received in response to this document 

must include the agency name and 

docket number (CDC–2022–0052; 

NIOSH–347) for this action. All relevant 

comments, including any personal 

information provided, will be posted 

without change to https://

www.regulations.gov. Do not submit 

comments by email. CDC does not 

accept comments by email. 

FOR FURTHER INFORMATION CONTACT: 

Rachel Weiss, Program Analyst, 

National Institute for Occupational 

Safety and Health, 1090 Tusculum 

Avenue, MS: C–46, Cincinnati, OH 

45226; telephone (855) 818–1629 (this is 

a toll-free number); email NIOSHregs@

cdc.gov. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Executive Summary 

A. Purpose of Regulatory Action 

B. Summary of Major Provisions 

C. Costs and Benefits 

II. Public Participation 

III. Background 

A. WTC Health Program Statutory 

Authority 

B. Methods Used by the Administrator To 

Determine Whether To Add Cancers to 

the List of WTC-Related Health 

Conditions 

C. History and Scope of Rulemaking 

D. Review of Evidence Supporting the 

Proposed Addition of Uterine Cancer to 

the List of WTC-Related Health 

Conditions 

E. Administrator’s Decision Regarding 

Uterine Cancer 

IV. Summary of Proposed Rule 

V. Required Regulatory Analyses 

A. Executive Orders 12866 and 13563 

B. Regulatory Flexibility Act 

C. Paperwork Reduction Act 

D. Small Business Regulatory Enforcement 

Fairness Act 

E. Unfunded Mandates Reform Act of 1995 

F. Executive Order 12988 (Civil Justice) 

G. Executive Order 13132 (Federalism) 

H. Executive Order 13045 (Protection of 

Children From Environmental Health 

Risks and Safety Risks) 

I. Executive Order 13211 (Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use) 

J. Plain Writing Act of 2010 

I. Executive Summary 

A. Purpose of Regulatory Action 

With this rulemaking, the 

Administrator of the WTC Health 

Program (Administrator) and the 

Secretary of HHS propose the addition 

of uterine cancer 1 to the List. The 

Administrator received requests from 

WTC responders and survivors as well 

as a September 2020 letter from five of 

the WTC Health Program Clinical 

Centers of Excellence (CCEs) asking the 

Administrator to add ‘‘uterine cancer’’ 

to the List. The Administrator 

subsequently directed the WTC Health 

Program’s Science Team to review the 

available scientific evidence for adding 

uterine cancer to the List under existing 

Program policy and procedures. A white 

paper issued by the Program’s Science 

Team in September 2021 (White Paper) 

found that the available scientific 

evidence provided sufficient support to 

add uterine cancer to the List but only 

for Program members who have a 

certified WTC-related estrogen-secreting 

tumor. The Administrator asked the 

WTC Health Program Scientific/ 

Technical Advisory Committee (STAC) 

for a recommendation on whether a 

reasonable basis exists for adding 

uterine cancer to the List. Between 

September and November 2021, the 

STAC reviewed the White Paper and 

other available scientific information, 

considered public comment, and 

deliberated on whether there is a 

reasonable basis to recommend the 

addition of uterine cancer to the List. 

Ultimately, the STAC recommended 

that uterine cancer be added to the List 

and provided the Administrator its 

recommendation and rationale. Upon 

review, the Administrator decided that 

the STAC provided a reasonable basis 

for its recommendation to add uterine 

cancer to the List. Based on the STAC’s 

recommendation and the scientific 

literature, including the White Paper, 

the Administrator has determined that 

the available information provides a 

sufficient evidentiary basis to propose 

the addition of uterine cancer to the 

List. 

B. Summary of Major Provisions 

This rule proposes the addition of 

malignant neoplasms of corpus uteri 

and uterus, part unspecified (uterine 

cancer) to the List of WTC-Related 

Health Conditions in 42 CFR 88.15(d). 

C. Costs and Benefits 

The addition of uterine cancer to the 

List through this rulemaking is 

estimated to cost the WTC Health 

Program from $1,718,691 to $2,199,808 

annually, between 2022 and 2025. All of 

the costs to the WTC Health Program are 

transfers.2 Benefits to current and future 


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27962 Federal Register / Vol. 87, No. 90 / Tuesday, May 10, 2022 / Proposed Rules 

coverage other than through the WTC Health 

Program; therefore, all projected treatment costs to 

be paid by the WTC Health Program are considered 

transfers. 

3See Public Health Service Act, sec. 

3312(a)(6)(F). 

4See Public Health Service Act, sec. 

3312(a)(6)(D)(ii). 

5See supra note 1. 

6Title XXXIII of the PHS Act is codified at 42 

U.S.C. 300mm to 300mm–61. Those portions of the 

Zadroga Act found in Titles II and III of Public Law 

111–347 do not pertain to the WTC Health Program 

and are codified elsewhere. 

7PHS Act, sec. 3312(a)(6)(B); 42 CFR 88.16(a). 

8PHS Act, sec. 3312(a)(6)(A); 42 CFR 88.16(b). 

9 John Howard, Administrator of the WTC Health 

Program, Policy and Procedures for Adding Types 

of Cancer Conditions to the List of WTC-Related 

Health Conditions, revised Nov. 18, 2021, https:// 

www.cdc.gov/wtc/pdfs/policies/WTCHP_PP_Addn_

Cancer_11182021-508.pdf. 

10See Hill AB [1965], The Environment and 

Disease: Association or Causation? Proc R Soc Med 

58:295–300. 

11Precision of the risk estimate describes the 

uncertainty inherent in estimating the strength of 

association (the effect size) between exposure and 

health effect from observational data. It is often 

expressed as a confidence interval illustrating a 

range of values that contains the true effect size. A 

narrow confidence interval indicates a more precise 

measure of the effect size and a wider interval 

indicates greater uncertainty. 

12Chemical, physical, biological, or other hazards 

reported in a published, peer-reviewed exposure 

assessment study of responders, recovery workers, 

or survivors who were present in the New York City 

disaster area, or at the Pentagon site, or the 

WTC Health Program members are 

expected to include improved access to 

care and better treatment outcomes than 

members would have in the absence of 

Program coverage. 

II. Public Participation 

Interested persons or organizations 

are invited to participate in this 

rulemaking by submitting written views, 

opinions, recommendations, and data. 

Comments received, including 

attachments and other supporting 

materials, are part of the public record 

and subject to public disclosure. 

Comments are invited on any topic 

related to this proposed rule. Do not 

include any information in your 

comment or supporting materials that 

you consider confidential or 

inappropriate for public disclosure. 

Comments submitted electronically or 

by mail should be titled ‘‘Docket No. 

CDC–2022–0052; NIOSH–347’’ and 

should identify the author(s) and 

contact information in case clarification 

is needed. Written comments can be 

submitted to the address provided in the 

ADDRESSES section, above. All 

communications received on or before 

the closing date for comments will be 

fully considered by the Administrator. 

Upon publication of this notice of 

proposed rulemaking, the Administrator 

has requested an independent peer 

review from three subject-matter experts 

of the scientific and technical evidence 

that comprises the basis of this action.3

The peer reviews will be posted, 

without attribution, in the rulemaking 

docket 30 days after the publication of 

this proposed rulemaking. 

To provide interested parties adequate 

time to review the proposed rule, 

supporting scientific literature, and peer 

reviews, and to submit written 

comments to the docket, the 

Administrator has determined that good 

cause exists to extend the 30-day 

comment period required by the 

Program’s authorizing statute 4 to 45 

days. 

III. Background 

In this action, the Administrator and 

the Secretary of HHS propose to amend 

42 CFR 88.15 to add malignant 

neoplasms of corpus uteri and uterus, 

part unspecified (uterine cancer) 5 to the 

List. 

A. WTC Health Program Statutory 

Authority 

Title I of the James Zadroga 9/11 

Health and Compensation Act of 2010 

(Pub. L. 111–347, as amended by Pub. 

L. 114–113 and Pub. L. 116–59), added 

Title XXXIII to the PHS Act 6

establishing the WTC Health Program 

within HHS. The WTC Health Program 

provides medical monitoring and 

treatment benefits to eligible firefighters 

and related personnel, law enforcement 

officers, and rescue, recovery, and 

cleanup workers who responded to the 

September 11, 2001, terrorist attacks in 

New York City, at the Pentagon, and in 

Shanksville, Pennsylvania (responders), 

and to eligible persons who were 

present in the dust or dust cloud on 

September 11, 2001 or who worked, 

resided, or attended school, childcare, 

or adult daycare in the New York City 

disaster area (survivors). 

All references to the Administrator in 

this document mean the Director of 

NIOSH, within CDC, or his or her 

designee. Section 3312(a)(6) of the PHS 

Act requires the Administrator to 

conduct rulemaking to propose the 

addition of a health condition to the List 

codified in 42 CFR 88.15. 

B. Methods Used by the Administrator 

To Determine Whether To Add Cancers 

to the List of WTC-Related Health 

Conditions 

In accordance with the Program’s 

authorizing statute as well as 

regulations in 42 CFR part 88, the 

Administrator may decide to propose 

the addition of a health condition to the 

List in response to a petition from an 

interested party 7 or at his or her own 

discretion.8 Under 42 CFR 88.16, the 

Administrator has established a process 

by which health conditions may be 

considered for addition to the List in 

§ 88.15. Pursuant to sec. 3312(a)(6)(D) of 

the PHS Act, whenever the 

Administrator determines that a 

condition should be proposed for 

addition to the List, the Administrator is 

required to publish a notice of proposed 

rulemaking and allow interested parties 

to comment on the proposed rule. 

The Program also developed the 

Policy and Procedures for Adding Types 

of Cancer to the List of WTC-Related 

Health Conditions (Policy and 

Procedures) to describe the evaluation 

of evidence of a causal association 

between 9/11 exposures and a type of 

cancer. Pursuant to these procedures, a 

type of cancer may be proposed for 

addition to the List if the available 

evidence meets at least one of the 

following four methods: 9

Method 1. Epidemiologic Studies of 

September 11, 2001-Exposed 

Populations. 

The peer-reviewed, published 

epidemiologic studies of 9/11-exposed 

populations are assessed by applying 

the following criteria extrapolated from 

the Bradford Hill criteria,10 as 

appropriate: 

a. Strength of the association between 

a 9/11 exposure and a type of cancer 

(including the precision of the risk 

estimate); 11

b. Consistency of the findings across 

multiple studies. If only a single 

published epidemiologic study is 

available for assessment, the 

consistency of findings cannot be 

evaluated, and more emphasis will be 

placed on evaluating the strength of the 

association and the precision of the risk 

estimate; 

c. Biological gradient, or doseresponse relationships between 9/11 

exposures and the type of cancer; and 

d. Plausibility and coherence with 

known facts about the biology of the 

type of cancer. 

Method 2. Established Causal 

Associations. 

A type of cancer may be added to the 

List if there is well-established scientific 

support published in multiple peerreviewed epidemiologic studies for a 

causal association between a condition 

already on the List and that cancer. 

Method 3. Review of Evaluations of 

Carcinogenicity in Humans. 

A type of cancer may be added to the 

List under Method 3 only if both of the 

following criteria are satisfied: 

3A. Published Exposure Assessment 

Information. A 9/11 agent 12 included in 


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Shanksville, Pennsylvania site, as those locations 

are defined in 42 CFR 88.1, as well as those hazards 

not identified in a published, peer-reviewed 

exposure assessment study, but which are 

reasonably assumed to have been present at any of 

the three sites. WTC Health Program, Development 

of the Inventory of 9/11 Agents, published Jul. 17, 

2018, https://wwwn.cdc.gov/ResearchGateway/ 

Content/pdfs/Development_of_the_Inventory_of_9- 

11_Agents_20180717.pdf. 

13The Inventory of 9/11 Agents is composed of 

those agents identified in Tables 1–4 of the 

document, Development of the Inventory of 9/11 

Agents. Id. 

14The STAC may base its recommendation and 

reasonable basis on criteria other than those 

outlined in Methods 1–3. 

15WTC Health Program final rule, Addition of 

Certain Types of Cancer to the List of WTC-Related 

Health Conditions, 77 FR 56138 (Sept. 12, 2012). 

16WTC Health Program interim final rule, 

Amendments to List of WTC-Related Health 

Condition; Cancer; Revision, 79 FR 9100 (Feb. 18, 

2014). 

17A cancer is considered to be on the List if it 

meets the definition of rare cancers in 42 CFR 

88.15(d)(24), which is any type of cancer * that 

occurs in less than 15 cases per 100,000 persons per 

year in the United States. 

* Based on 2005–2009 average annual data ageadjusted to the 2000 U.S. population. See Glenn 

Copeland, Andrew Lake, Rick Firth, et al. (eds), 

Cancer in North America: 2005–2009. Volume One: 

Combined Cancer Incidence for the United States, 

Canada and North America, Springfield, IL: North 

American Association of Central Cancer Registries, 

Inc., June 2012. 

See also the Administrator’s Policy and 

Procedures for Rare Cancers, https://www.cdc.gov/ 

wtc/pdfs/policies/WTCHP_PP_

RareCancers05052014-508.pdf. 

18Although the List does not identify health 

condition medical diagnostic codes, the Program 

uses ICD–10 codes internally to track certified 

conditions. Malignant neoplasms of female genital 

organs comprise ICD–10 codes C51–C58 and 

include malignant neoplasms of the female genital 

organs: Vulva (C51), vagina (C52), cervix uteri 

(C53), corpus uteri (C54), uterus, part unspecified 

(C55), ovary (C56), other and unspecified female 

genital organs (C57), and placenta (C58). Uterine 

sarcomas are included in ICD–10 C55. ICD–10 

codes C54 and C55 are not currently considered 

WTC-related health conditions. World Health 

Organization (WHO) [1997], International 

Classification of Diseases, Tenth Edition. 

19See supra note 17. 

20See supra note 1. 

21The endometrium is the layer of tissue that 

lines the uterus. National Cancer Institute, 

Dictionary of Cancer Terms, https://

www.cancer.gov/publications/dictionaries/cancerterms/def/endometrium. Endometrial cancer 

accounts for nearly 90 percent of uterine cancer 

cases. See also American Society of Clinical 

Oncology [2021], Uterine Cancer: Statistics, https:// 

www.cancer.net/cancer-types/uterine-cancer/ 

statistics. 

22 Interested parties may petition the 

Administrator to add health conditions to the List. 

To be considered a valid petition, a submission 

must meet the criteria established in 42 CFR 

88.16(a)(1) and further described in the Policy and 

Procedures for Handling Submissions and Petitions 

to Add a Health Condition to the List of WTCRelated Health Conditions, https://www.cdc.gov/ 

wtc/pdfs/policies/WTCHPPPPetitionHandling

Procedures14May2014-508.pdf. 

23WTC Health Program Federal Register 

document, Petition 023-Uterine Cancer, Including 

Endometrial Cancer; Finding of Insufficient 

Evidence, 84 FR 49954 (Sept. 24, 2019). 

24 Inventory of 9/11 Agents means those 9/11 

agents identified as being present at a 9/11 site and 

included in Tables 1–4 of the WTC Health Program 

publication, Development of the Inventory of 9/11 

Agents, Jul. 17, 2018, https://wwwn.cdc.gov/ 

ResearchGateway/Content/pdfs/Development_of_

the_Inventory_of_9-11_Agents_20180717.pdf. EDCs 

in the Inventory of 9/11 Agents include persistent 

organic pollutants and other industrial substances 

such as cadmium, dioxins, perfluoroalkyl and poly 

fluoroalkyl substances (PFAS), phthalates, 

polybrominated diphenyl ethers (PBDE), and 

polychlorinated biphenyls (PCB). None of these 9/ 

11 agents have been found by NTP or IARC to be 

known to cause or reasonably anticipated to cause 

uterine cancer. 

25Although this rulemaking refers to uterine 

cancer in females, the WTC Health Program 

recognizes that some individuals who identify as 

male may also be at risk for uterine cancer. 

the Inventory of 9/11 Agents 13 is 

identified; and 

3B. Evaluation of Carcinogenicity in 

Humans from Scientific Studies. NTP 

[the National Toxicology Program] has 

determined that the 9/11 agent is known 

to be a human carcinogen or is 

reasonably anticipated to be a human 

carcinogen, and the IARC [the World 

Health Organization’s International 

Agency for Research on Cancer] has 

determined that there is sufficient or 

limited evidence in humans that the 9/ 

11 agent causes the type of cancer. 

Method 4. Review of Information by 

the WTC Health Program Scientific/ 

Technical Advisory Committee (STAC). 

A type of cancer may be added to the 

List if the STAC recommends the 

addition and provides a reasonable basis 

for the recommendation.14 To assist the 

Administrator in understanding 

whether the STAC’s recommendation 

has a reasonable basis, the STAC must 

describe in detail the basis for its 

recommendation and, if applicable, any 

evidentiary sources it has used to 

support its recommendation. 

C. History and Scope of Rulemaking 

In September 2012, the Administrator 

published a final rule adding most types 

of cancer to the List,15 codified at 42 

CFR 88.15(d). The 2012 rulemaking 

added malignant neoplasm of the ovary 

(ovarian cancer) to the List pursuant to 

Method 3, described above; rare cancers 

were also added to the List pursuant to 

Method 4. In a follow-up rulemaking 

conducted in February 2014,16 the 

Program clarified the definition of ‘‘rare 

cancers’’ to include any type of cancer 

that occurs in less than 15 cases per 

100,000 persons.17 As a result of this 

rulemaking other—but not all—types of 

malignant neoplasms of female genital 

organs,18 including cervix uteri 

(invasive cervical cancer) and uterine 

sarcomas, were found to meet the 

revised definition of rare cancers.19

Uterine cancer 20 was not added to the 

List because the scientific evidence 

available at the time of the 2012 and 

2014 rulemakings did not provide 

sufficient support for its inclusion; nor 

did it meet the definition of rare cancer. 

Since 2012, the WTC Health Program 

has received eight submissions 

requesting the addition of endometrial 

or uterine cancer to the List. Only one 

of these submissions, Petition 023, 

received in 2019 and requesting the 

addition of ‘‘endometrial cancer,’’ 21 was 

determined to be a valid petition.22 In 

response, the Program conducted a 

literature search and identified and 

evaluated seven published, peerreviewed, epidemiologic studies about 

uterine cancer, including endometrial 

cancer, in the 9/11-exposed population. 

Ultimately, in 2019, the Administrator 

determined that the evidence was 

insufficient to support adding uterine 

cancer, including endometrial cancer, to 

the List.23

On September 11, 2020, the 

Administrator received a submission 

from five of the Program’s CCEs, 

requesting the addition of uterine cancer 

to the List. Although the Program 

determined that the submission was not 

a valid petition, the Administrator 

thought that it raised important 

questions about the potential 

association between endocrine 

disrupting chemicals (EDCs) and 

hormone-related tumors such as 

endometrial cancer. The CCEs noted 

that the WTC Health Program’s 

scientific literature evaluation 

conducted for Petition 023 did not 

include consideration of the 

relationship between EDCs and uterine 

cancer, despite some EDCs being 

included in the Inventory of 9/11 

Agents.24 The CCEs argued that research 

that has emerged since 2012 suggests 

EDCs may have a role in the 

development of estrogen-related 

diseases such as endometrial cancer. 

Moreover, the CCEs noted the low 

numbers of female 25 WTC responders 

in the occupational studies of the health 

effects of 9/11 exposure and expressed 

concern that this may lead to gaps in the 

research. 

The Administrator determined that a 

more thorough evaluation of the 

scientific information regarding uterine 

cancer available since 2012 was needed 

and asked the WTC Health Program 

Science Team (Science Team) to 

conduct a review of the available 

scientific evidence to determine 

whether it might now support adding 

uterine cancer to the List. The Science 

Team conducted a literature review and 

issued a White Paper (discussed below) 

documenting its findings in September 

2021. The White Paper describes the 


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26See PHS Act, sec. 3312(a)(6)(A). 

27Administrator’s Charge to the World Trade 

Center Health Program Scientific/Technical 

Advisory Committee, https://www.cdc.gov/wtc/ 

pdfs/stac/STAC_AdmCharge_Revised20210928- 

P.pdf. 

28World Trade Center Health Program Scientific/ 

Technical Advisory Committee, Executive 

Summary of Meeting, September 28–29, 2021, 

https://www.cdc.gov/wtc/pdfs/stac/WTCHP_

STACmeetingMinutes_20210928-29.pdf. 

29Per STAC bylaws, a quorum consists of a 

majority of the committee’s membership. Based on 

the membership at the time of the meeting, the 

required number of members for a quorum was 

nine. Four members were unable to attend the 

November 18, 2021, meeting, however 12 members 

were in attendance and quorum was maintained 

throughout the meeting. 

30WTC Health Program [2021], Scientific 

Considerations for Potential Addition of Uterine 

Cancer to the List of Covered Conditions by the 

World Trade Center Health Program (Revised): 

Preliminary Assessment for the World Trade Center 

Health Program Scientific/Technical Advisory 

Committee. The Science Team’s White Paper is 

available in the docket for this rulemaking and on 

the WTC Health Program website, at https://

www.cdc.gov/wtc/pdfs/stac/Scientific

ConsiderationsUterineCancer_STAC_20210928.pdf. 

31A seventh study was evaluated in the Petition 

023 review but was not considered in the Science 

Team’s evaluation for reasons described in the 

White Paper, id. at 8. 

32See full discussion of the Science Team’s 

literature review and findings regarding Method 1 

in the White Paper, id. at 8–17. 

33 Id. at 6–7. 

34See full discussion of the Science Team’s 

review of the scientific literature and findings 

regarding Method 2 in the White Paper, supra note 

30, at 17–18. 

35 Id. at 7. 

36 Id. at 7. 

Science Team’s conclusion that 

insufficient evidence exists to support a 

decision to add uterine cancer to the 

List under Methods 1 or 3 of the Policy 

and Procedures described above; 

evidence considered under Method 2 

supports adding uterine cancer to the 

List, but only for those Program 

members who have a certified WTCrelated estrogen-secreting tumor. 

Pursuant to Method 4 of the Policy 

and Procedures, the Administrator 

exercised his discretion to request a 

recommendation from the STAC26

regarding whether the available 

evidence provides a reasonable basis 

exists for adding uterine cancer to the 

List. The Administrator convened the 

STAC on September 28–29, 2021, and 

gave the Committee the following 

charge: 

As you are aware, the WTC Health Program 

currently covers all major types of cancer, 

except for uterine cancer. I welcome the 

Committee’s evaluation and recommendation 

on whether there is a reasonable scientific 

basis to support adding uterine cancer to the 

List of WTC-Related Health Conditions.27

At the September 2021 meeting, the 

Science Team presented the White 

Paper describing the available scientific 

evidence for an association between 

uterine cancer and 9/11 exposures. The 

STAC heard public comment and 

deliberated on the evidence presented 

in the White Paper. The Committee 

ultimately decided to create a 

workgroup to ‘‘write a report describing 

the committee’s conclusion, scientific 

rationale, and supporting evidence for 

adding uterine cancer as a WTC-related 

health condition.’’ 28 At a follow-up 

meeting on November 18, 2021, the 

workgroup presented their draft report 

to the Committee. Following 

deliberation, the 12 STAC members 

present 29 voted unanimously to 

approve the report and recommend that 

the Administrator add uterine cancer to 

the List. Both the White Paper and the 

STAC recommendation are discussed 

below. 

D. Review of Evidence Supporting the 

Proposed Addition of Uterine Cancer to 

the List 

1. WTC Health Program Science Team 

Review 

As discussed above, the 

Administrator asked the Science Team 

to assess the scientific evidence 

currently available to determine 

whether a basis exists under the Policy 

and Procedures for proposing the 

addition of uterine cancer to the List. 

The Science Team reported its findings 

in the White Paper entitled, Scientific 

Considerations for Potential Addition of 

Uterine Cancer to the List of Covered 

Conditions by the World Trade Center 

Health Program (Revised): Preliminary 

Assessment for the World Trade Center 

Health Program Scientific/Technical 

Advisory Committee.30 The White Paper 

describes the scope of the Science 

Team’s query as well as the literature 

search and inclusion criteria, and 

summarizes the studies identified that 

describe the available evidence on 

causal relationships between 9/11 

exposures and uterine cancer. 

Pursuant to Method 1, the Science 

Team conducted a literature search in 

April 2021. As described in the White 

Paper, the Science Team identified and 

summarized nine studies: Six which 

were previously evaluated in the 

Petition 023 Federal Register 

document,31 one that recapitulated the 

results of two of those previously 

evaluated studies, and two additional 

studies published since the Petition 023 

literature search and evaluation were 

conducted. Ultimately, five studies were 

found to be relevant for further 

evaluation, including some of the earlier 

studies which have been recently 

updated by their authors.32 With regard 

to Method 1, the Science Team 

concluded: 

Five relevant peer-reviewed, published, 

epidemiologic studies were identified and 

reviewed. The studies do not provide 

consistent evidence of elevated uterine 

cancer incidence or mortality among WTC 

responders and survivors. The studies also 

do not report a dose-response relationship 

between 9/11 exposures and uterine cancer 

and the study designs may be susceptible to 

selection bias. As a result, collectively, these 

studies do not demonstrate a potential to 

provide a basis for a decision on whether to 

add uterine cancer to the List.33

Pursuant to Method 2, the Science 

Team explored whether a causal 

association exists between uterine 

cancer and a health condition already 

on the List. The Science Team found 

that uterine cancer may be medically 

associated with estrogen-secreting 

tumors, which are considered rare 

cancers in the Program. Studies 

reviewed by the Science Team 

demonstrate support for a causal 

association between granulosa cell 

tumors of the ovary (the most common 

type of estrogen-secreting tumor) and 

uterine cancer.34 With regard to Method 

2, the Science Team concluded: 

A thorough review of the scientific 

literature found that estrogen-secreting 

tumors are associated with endometrial 

cancer, but that these estrogen-secreting 

tumors are rare. Because estrogen-secreting 

tumors fall under the category of ‘‘rare 

cancers’’ in the List, uterine cancer [may be 

considered a medically associated condition 

and thus] . . . added to the List only for 

members who have a certified estrogensecreting tumor.35

Pursuant to Method 3, the Science 

Team considered the evaluations of 

carcinogenicity published by NTP and 

IARC of those EDCs that are 9/11 agents 

identified in the Inventory of 9/11 

Agents. With regard to Method 3, the 

Science Team concluded: 

Four EDCs listed in the Inventory of 9/11 

Agents are considered carcinogenic to 

humans by NTP or IARC: (1) 2,3,7,8- 

tetrachlorodibenzodioxin (TCDD); (2) 

2,3,4,7,8-pentachlorodibenzofuran; (3) 

polychlorinated biphenyls (PCB); and (4) 

cadmium. None of these agents is considered 

to have sufficient or even limited evidence of 

uterine carcinogenicity [based on IARC’s 

Monographs]. Further review of 

epidemiologic studies published after . . . 

[IARC’s Monographs] did not identify 

additional evidence of carcinogenicity to the 

uterus.36

In addition, since Method 4 allows a 

cancer to be proposed for addition to the 

List if the STAC provides a reasonable 

basis, the Science Team presented 


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37 Id. at 27. 

38WTC Health Program STAC, Executive 

Summary of Meeting, September 28–29, 2021, 

https://www.cdc.gov/wtc/stac_meeting.html, at 2. 

39Letter from Dr. Elizabeth Ward, Chair of the 

STAC, to the Administrator, regarding the STAC’s 

resolution on the addition of uterine cancer to the 

List of WTCHP Covered Conditions, received 

November 29, 2021. The letter from Dr. Ward, 

including the STAC’s recommendation is available 

in the docket for this rulemaking and on the WTC 

Health Program website, at https://www.cdc.gov/

wtc/pdfs/stac/STAC.Recommendation.

Received.29.November.2021.pdf. 

40Letter from Dr. Elizabeth Ward, Chair of the 

STAC, to the Administrator, regarding the STAC’s 

resolution on the addition of cancer to the List of 

WTC-Related Health Conditions, received Apr. 2, 

2012, https://www.cdc.gov/niosh/docket/archive/

pdfs/NIOSH-248/0248-040212-Letter.pdf. 

41Supra note 39, at 6. 

42 Id. at 7. 

43 Id. at 2. 

44 Id. 

45 In footnote 1 of its recommendation, the STAC 

clarifies that ‘‘endometrial’’ and ‘‘uterine’’ cancer 

are used synonymously and that most of the 

literature reviewed by the STAC relates specifically 

to endometrial cancer. The STAC recommendations 

pertain to all types of uterine cancer, including 

endometrial cancer. 

46See supra note 39, at Attachment 1. 

47 Id. at 8. 

48See full discussion of the STAC’s review of the 

scientific literature and findings in Attachment 1, 

sec. 2 of the STAC recommendation, supra note 39. 

49 Id. at 10. 

supplementary evidence that was 

reviewed but found not to be applicable 

to Methods 1, 2, or 3 for the STAC’s 

consideration. First, the Science Team 

described the commonalities between 

the mechanisms of development for 

uterine cancer and other types of cancer, 

including ‘‘estrogen, an abnormal 

mismatch repair (MMR) system, genetic 

abnormalities, and aberrant methylation 

of DNA and microRNA.’’ 37 Next, the 

Science Team presented evidence from 

studies in non-9/11-exposed 

populations that demonstrate 

associations between uterine cancer and 

the 9/11 agents TCDD, PCBs, cadmium, 

and asbestos (known EDCs). 

Additionally, the Science Team noted 

that most studies of EDC exposure are 

conducted among occupational cohorts, 

including few or no women. Finally, the 

Science Team presented evidence that 

some EDCs in the Inventory of 9/11 

Agents, including 2,3,7,8- 

tetrachlorodibenzodioxin and PCBs, are 

considered by NTP and IARC to be 

known or probable human carcinogens 

associated with types of cancer other 

than uterine cancer (e.g., melanoma, 

breast cancer, lymphoma, and 

leukemia), supporting the inference that 

some EDC 9/11 agents may also be 

linked to uterine cancer. 

2. WTC Health Program Scientific/ 

Technical Advisory Committee Review 

After being presented with the White 

Paper at the September 28–29, 2021, 

STAC meeting, the Committee created a 

workgroup to ‘‘write a report describing 

the committee’s conclusion, scientific 

rationale, and supporting evidence for 

adding uterine cancer as a WTC-related 

health condition.’’ 38 Following the 

deliberation of the full committee at the 

November 18, 2021, meeting, the STAC 

voted to recommend that uterine cancer 

be added to the List. The Chair of the 

STAC sent a letter with the Committee’s 

formal recommendation and rationale to 

the Administrator, which he received on 

November 29, 2021.39

The STAC recommendation is 

grounded in evidence and principles 

first developed by the STAC in its 2012 

recommendation to the Administrator 

concerning the addition of cancers to 

the List.40 The 2021 STAC 

recommendation quotes the 2012 STAC 

recommendation, which described those 

principles as including an 

understanding that ‘‘exposures resulting 

from the collapse of the World Trade 

Center were unlike any other exposures 

in intensity and variety in history. . . . 

Compounding the uniqueness of the 

exposures is the absence of any data on 

air contaminant levels or the 

composition of the dust and fumes in 

the first four days after the attack, and 

the presence of multiple and complex 

exposures.’’ 41 Further, the STAC found 

in 2012 that ‘‘both responder 

populations and area residents and 

workers had potential for significant 

exposures to toxic and carcinogenic 

components of WTC dust and 

smoke.’’ 42

The STAC also revisited the 

arguments presented in the 2012 STAC 

recommendation for the addition of all 

cancer types, adding that: 

. . . we believe that the arguments for adding 

all cancers can apply to the question of 

whether to include all types of uterine 

cancer. Other than uterine cancer, all cancer 

types now are covered as WTC-related 

conditions. Mechanisms for carcinogenesis 

resulting from endogenous and exogenous 

exposures are similar for most cancer types. 

It is therefore highly implausible that uterine 

cancer would be the only cancer not related 

to WTC exposures.43

In fact, in reviewing the literature, the 

STAC found that uterine cancer ‘‘shares 

many of the same genetic mechanisms 

with cancers already included in [the] 

List of WTC-Related Health 

Conditions.’’ 44 Because exposure to 

endogenous and exogenous estrogen is 

strongly associated with both 

endometrial 45 and breast cancer, the 

STAC found exposure to EDCs in WTC 

dust to be ‘‘particularly relevant.’’ 

Noting that the 2012 STAC 

recommendation did not review 

evidence supporting an association 

between EDCs and cancer types, the 

November 2021 recommendation 

summarized the STAC’s understanding 

of exposures to EDCs and their possible 

association with uterine cancer.46

The STAC acknowledged that 

‘‘[s]tudying the potential health effects 

of exposure to EDCs is inherently 

challenging and much remains 

unknown despite decade[s] of 

research,’’ and quoted a recent review 

which described EDCs’ multiple 

mechanisms of action, acting 

‘‘simultaneously at the level of the 

receptor, hormone synthesis, and 

hormone degradation.’’ 47

The STAC noted that the Inventory of 

9/11 Agents includes certain 9/11 agents 

which are recognized as EDCs. 

Specifically, the STAC noted that 

elevated levels of polychlorinated 

dibenzo-para-dioxins and 

polychlorinated dibenzofurans (PCDD/ 

F) were found on window surfaces from 

locations in lower Manhattan and 

Brooklyn six weeks after September 11, 

2001. Other EDCs were found in WTC 

dust and smoke samples and in runoff 

samples from Rector Street on 

September 14 and 20, 2001. Two 

biomonitoring studies demonstrated 

significantly elevated levels of EDCs in 

9/11-exposed cohorts: A study of 

perfluorochemicals in plasma from 

WTC responders working near Ground 

Zero between September 11 and 

December 23, 2001 found levels of 

perfluorooctanoic acid (PFOA) and 

perfluorohexanesulfonate (PFHxS) twice 

as high as in the U.S. general 

population; and a study comparing 9/ 

11-exposed adolescents to non-9/11- 

exposed adolescents found that PCDD/ 

F levels were statistically significantly 

higher among the 9/11-exposed 

cohort.48 The STAC found that PBDEs, 

high levels of which were found in WTC 

dust, in particular have been shown to 

‘‘interfere with estrogen- . . . mediated 

processes’’ and that ‘‘some toxicologic 

studies provide indirect evidence’’ for 

an association between PBDE exposures 

and uterine cancer.49

The STAC found that EDC exposurerelated imbalances in sex steroid 

hormones are a ‘‘plausible mechanism’’ 

for the development of uterine cancer 

among WTC responders and survivors. 

Hormone-related cancers thought to be 

caused by EDC exposure include 

thyroid cancer, breast cancer, testicular 

and prostate cancers, and all female 

reproductive organ cancers, all of which 

are included on the List with the 

exception of uterine cancer. 


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50See full discussion of the STAC’s review of the 

scientific literature and findings in Attachment 1, 

sec. 2 of the STAC recommendation, supra note 39. 

51 Id. at 5. 

52 ICD–10 codes C54 and C55. See supra note 1. 

53Banno K, Yanokura M, Iida M, Masuda K, Aoki 

D [2014], Carcinogenic Mechanisms of Endometrial 

Cancer: Involvement of Genetics and Epigenetics, J 

Obstet Gynaecol Res 40(8):1957–1967; Urick ME 

and Bell DW [2019], Clinical Actionability of 

Molecular Targets in Endometrial Cancer, Nat Rev 

Cancer 19, 510–521. 

54Levine DA and the Cancer Genome Atlas 

Research Network [2013], Integrated Genomic 

Characterization of Endometrial Carcinoma, Nature 

497(7447):67–73. 

55Favier A, Rocher G, Larsen AK, Delangle R, 

Uzan C, Sabbah M, Castela M, Duval A, Mehats C, 

Canlorbe G [2021], MicroRNA as Epigenetic 

Modifiers in Endometrial Cancer: A Systematic 

Review, Cancers (Basel) 6;13(5):1137. 

56Pan-cancer molecular studies examine the 

similarities and differences among the genomic and 

cellular alterations found across diverse tumor 

types. Weinstein JN, Collisson EA, Mills GB, Mills 

Shaw KR, Ozenberger BA, Ellrott K, Shmulevich I, 

Sander C, Stuart JM [2013]. The Cancer Genome 

The STAC also commented on the 

likely inability of existing and future 

epidemiologic studies in the 9/11- 

exposed responder population—the 

most studied 9/11-exposure cohort—to 

accurately capture uterine cancer 

incidence because of the small number 

of female responders. Moreover, the 

STAC noted that studies of carcinogens 

reviewed by IARC and other 

authoritative bodies typically represent 

industrial cohorts, which often include 

few or no females, making finding an 

association between a 9/11 agent and 

uterine cancer highly unlikely and thus 

potentially foreclosing Method 3 as a 

basis for adding uterine cancer to the 

List. 

Finally, the STAC considered public 

comment as well as the strong support 

of the WTC Health Program CCEs for the 

addition of uterine cancer to the List, 

noting that many Program members and 

advocates feel the exclusion of uterine 

cancer from the List is ‘‘illogical and 

unfair and may cause tangible harm.’’ 

The STAC cited a recent study 50

supporting the argument that WTC 

responders and survivors diagnosed 

with uterine cancer will experience 

better cancer survival if uterine cancer 

is covered by the Program due to 

treatment coverage and high-quality 

care. 

After reviewing the available evidence 

and hearing comment from both the 

public and the WTC Health Program’s 

CCEs, the STAC concluded that: 

In view of the strong rationale for adding 

all types of uterine cancer to the list of WTCrelated cancers and the potential benefits to 

affected WTC responders, WTC survivors, 

and providers caring for these patients, we 

recommend that all types of uterine cancer be 

added to the list of WTC-related cancers and 

urge the Administrator to make all feasible 

efforts to do so as quickly as policies and 

procedures allow.51

E. Administrator’s Decision Regarding 

Uterine Cancer 

After reviewing the available body of 

scientific evidence describing the causal 

relationship between 9/11 exposures 

and uterine cancer, including certain 9/ 

11 agents which are known EDCs, as 

well as evaluating the STAC’s 

comprehensive rationale and 

recommendation, the Administrator 

concludes that the totality of available 

information provides a sufficient 

evidentiary basis to propose adding 

uterine cancer 52 to the List. 

In accordance with the Program’s 

Policy and Procedures, the 

Administrator evaluated the available 

information under the four methods 

developed for determining whether to 

add a type of cancer to the List. First, 

he assessed whether there was sufficient 

evidence in peer-reviewed, published, 

epidemiologic studies of 9/11-exposed 

populations to support adding uterine 

cancer to the List under Method 1. The 

Administrator concurs with the Science 

Team’s evaluation of the literature 

pursuant to Method 1 and finds that the 

available literature does not provide 

sufficient support for the addition of 

uterine cancer to the List under Method 

1. 

Next, he looked at Method 2 which 

permits an addition to the List if 

multiple peer-reviewed epidemiologic 

studies establish a causal association 

between a condition already on the List 

and that cancer. The Administrator 

agrees with the Science Team’s finding 

that there is evidence of a causal 

association between estrogen-secreting 

tumors, which are considered rare 

cancers in the Program, and uterine 

cancer. Thus, the Administrator finds 

that uterine cancer may be proposed for 

addition to the List pursuant to Method 

2, but such an addition would be 

limited to only those Program members 

who have a certified WTC-related 

estrogen-secreting tumor. 

The Administrator also examined 

NTP and IARC evaluations of 

carcinogenicity under Method 3, which 

permits an addition to the List if NTP 

has determined that a specific 9/11 

agent is known to be a human 

carcinogen or is reasonably anticipated 

to be a human carcinogen, and IARC has 

determined that there is sufficient or 

limited evidence in humans that the 9/ 

11 agent causes the type of cancer. The 

Administrator reviewed the NTP and 

IARC evaluations of those EDCs that are 

on the Inventory on 9/11 Agents (i.e., 

TCDD, 2,3,4,7,8- 

pentachlorodibenzofuran, PCB, and 

cadmium) and concurs with the Science 

Team’s finding that there is insufficient 

support for the addition of uterine 

cancer pursuant to Method 3. 

Finally, the Administrator reviewed 

the recommendation of the STAC to 

determine if uterine cancer could be 

added to the List pursuant to Method 4, 

which permits an addition where the 

STAC recommends such an addition 

and provides a reasonable basis for the 

recommendation. The Administrator 

finds that the STAC’s recommendation 

provides a reasonable basis for the 

addition of uterine cancer under 

Method 4 and this recommendation is 

further supported by the supplemental 

information presented by the Science 

Team in the White Paper. 

Specifically, the Administrator agrees 

with the STAC’s finding that 

mechanisms of initiation and 

progression of uterine cancer are similar 

to those for several other cancers on the 

List.53 In particular, the evidence 

showing similar gene mutations and 

abnormal mismatch repair proteins 

among many cancers, including uterine 

cancer, strongly supports shared 

etiology and pathogenesis between 

uterine cancer and other cancer types on 

the List. For example, gene mutations 

found in low-grade, endometrioid 

endometrial cancer (which accounts for 

80 percent of all endometrial cancers) 

include those in PTEN (phosphatase 

and tensin homolog deleted on 

chromosome 10), CTNNB1 (b-catenin), 

and K–RAS. PTEN inactivation is 

similarly found in malignant melanoma, 

brain tumors, and ovarian, thyroid, 

breast, and prostate cancers, while 

CTNNB1 and K–RAS mutations are 

found in a variety of human cancers. 

High-grade endometrial cancers are 

associated with mutations in oncogene 

ERBB2 (HER–2/neu) and tumor 

suppressor gene TP53. ERBB2 gene 

mutations are also found in breast and 

ovarian cancers; likewise, TP53 is 

frequently mutated in a variety of 

human cancers, including high-grade 

serous ovarian and basal-like breast 

cancers.54 Finally, studies have shown 

that several microRNAs (miRNAs), 

including miR–152 which plays a role 

as a tumor suppressor, can be 

epigenetically silenced by hypermethylation of their respective DNA 

locus in endometrial cancer.55 Aberrant 

methylation of miR–152 has also been 

reported for other cancers, including 

acute lymphoblastic leukemia, 

gastrointestinal cancer, and 

cholangiocarcinoma. Recent pan-cancer 

molecular studies 56 have found shared 


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Atlas Pan-Cancer analysis project, Nature Genetics. 

45 (10): 1113–1120. 

57Berger AC et al. [2018], A Comprehensive PanCancer Molecular Study of Gynecologic and Breast 

Cancers, Cancer Cell 33(4):690–705. 

58See supra note 1. 

59As discussed in this section, NIOSH estimated 

lower and upper bound estimates to reflect the 

uncertainty in the Agency’s ability to predict the 

expected number of cancer cases in three years after 

this rulemaking. The low bound reflects the general 

U.S. population cancer rate and uses undiscounted 

costs for 2022 and costs for 2023–2025 discounted 

at the 7% discount rate. The upper bound reflects 

the U.S. population cancer rate + 21%, based on a 

study by Li et al. [2021], infra note 69, and uses 

undiscounted rates for 2022 and costs for 2023– 

2025 discounted at the 3% discount rate. Although, 

if added to the List, uterine cancer would be 

considered a covered condition for the duration of 

the WTC Health Program (currently authorized 

through FY 2090), the dates 2022–2025 were chosen 

in order to provide a snapshot of uterine cancer 

costs in the coming years. 

60Because sec. 3331(c)(3) of the PHS Act requires 

WTC Health Program members to maintain 

minimum essential insurance coverage all treatment 

costs to be paid by the WTC Health Program are 

considered transfers. 

61See supra note 25. 

molecular features among invasive 

breast carcinoma and several 

gynecologic tumors, such as high-grade 

serous ovarian cystadenocarcinoma, 

uterine corpus endometrial carcinoma, 

cervical squamous cell carcinoma and 

endocervical adenocarcinoma, and 

uterine carcinosarcoma.57 The 

Administrator agrees with the STAC’s 

finding that the shared etiology and 

pathogenesis described in the scientific 

literature suggest it would be unlikely 

that uterine cancer would be the only 

cancer type not related to 9/11 

exposures. 

The Administrator also finds that an 

association between exposure to EDCs 

in WTC dust and uterine cancer risk is 

plausible. EDCs can mimic endogenous 

hormones and interfere with 

endogenous hormone homeostasis, 

which may lead to a variety of adverse 

health outcomes, including cancer (e.g., 

estrogen imbalances are a key risk factor 

for uterine cancer). There is extensive 

evidence from human studies of an 

etiologic role of estrogens in cancer. 

However, finding a causal association 

between an EDC 9/11 agent and uterine 

cancer is highly unlikely given the 

potentially long latency between 

exposure and disease. Moreover, the 

low number of women included in 

epidemiologic studies examining EDC 

carcinogenic risks in occupational 

cohorts increases the difficulty in 

finding conclusive evidence of a causal 

association with uterine cancer. Given 

the growing body of scientific evidence 

suggesting that exposure to EDCs may 

be a risk factor for female reproductive 

organ cancers (e.g., breast, ovarian, and 

endometrial cancers), it is reasonable to 

assume that exposure to EDCs in WTC 

dust may contribute to uterine cancer 

risk. 

Finally, the Administrator recognizes 

that the disproportionally low 

representation of women in the most 

studied cohorts of exposed responders 

makes it epidemiologically unlikely that 

a definitive association between 9/11 

exposures and the occurrence of uterine 

cancer will be identified during the 

lifetime of even the most highly exposed 

Program members. 

The Administrator has determined 

that the available scientific evidence 

and rationale provided by the STAC in 

its recommendation, supported by the 

supplemental information presented by 

the Science Team in the White Paper, 

offers a plausible rationale for an 

association between uterine cancer and 

EDCs in the Inventory of 9/11 Agents. 

Moreover, the cohorts relevant to 

understanding uterine cancer in the 9/ 

11-exposed population are too small to 

allow a definitive decision about 

whether uterine cancer is causally 

associated with 9/11 exposure. For these 

reasons, the Administrator finds that a 

reasonable basis has been provided by 

the STAC under Method 4 and, 

accordingly, proposes to add uterine 

cancer to the List of WTC-Related 

Health Conditions. 

IV. Summary of Proposed Rule 

For the reasons discussed above, the 

Administrator proposes to amend 42 

CFR 88.15 by adding a new paragraph 

(d)(15) to include malignant neoplasms 

of corpus uteri and uterus, part 

unspecified 58 on the List of WTCRelated Health Conditions. The existing 

paragraph (d)(15)—malignant neoplasm 

of the ovary—and the remainder of the 

cancer types identified in existing 

paragraphs (d)(16) through (24)—rare 

cancers—are renumbered paragraphs 

(d)(16) through (25), accordingly. 

Adding uterine cancer to the List would 

allow the WTC Health Program to offer 

treatment services to members whose 

uterine cancers are certified as WTCrelated. 

V. Required Regulatory Analyses 

A. Executive Order 12866 (Regulatory 

Planning and Review) and Executive 

Order 13563 (Improving Regulation and 

Regulatory Review) 

Executive Orders (E.O.) 12866 and 

13563 direct agencies to assess all costs 

and benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects, distributive impacts, and 

equity). E.O. 13563 emphasizes the 

importance of quantifying both costs 

and benefits, reducing costs, 

harmonizing rules, and promoting 

flexibility. 

This proposed rule has been 

determined not to be a significant 

regulatory action under sec. 3(f) of E.O. 

12866, and therefore has not been 

reviewed by the Office of Management 

and Budget (OMB). The addition of 

uterine cancer proposed by this 

rulemaking is estimated to cost the WTC 

Health Program between $1,718,691 and 

$2,199,808 per annum for 2022–2025.59

All costs to the WTC Health Program 

will be transfers due to the 

implementation of provisions of the 

Patient Protection and Affordable Care 

Act (Pub. L. 111–148) in 2014 and as 

required under the authorizing statute 

for the WTC Health Program.60 The rule 

would not interfere with state, local, or 

tribal governments in the exercise of 

their governmental functions. 

Population Estimates 

The WTC Health Program has, as of 

September 30, 2021, enrolled 

approximately 82,000 WTC responders 

and approximately 32,000 survivors, or 

approximately 114,000 individuals in 

total. Of that total population, 

approximately 60,000 individuals were 

participants in previous WTC medical 

programs and were enrolled as ‘‘Legacy’’ 

members in the WTC Health Program 

established by Title XXXIII of the PHS 

Act. For the purpose of calculating a 

baseline estimate of cancer prevalence 

only, the Administrator assumed that a 

steady rate of enrollment would 

continue, based on the trend in 

enrollees through September 2021. 

According to WTC Health Program 

data, 12 percent of the current 

responder members (approximately 

10,000 individuals) and 50 percent of 

survivor members (approximately 

16,000 individuals) are female.61 The 

Administrator acknowledges that some 

uterine cancer cases in this population 

may not have been caused by 9/11 

exposures. The certification of 

individual cancer diagnoses will be 

conducted on a case-by-case basis, as 

required by the Zadroga Act. For the 

purpose of this economic analysis, 

however, the Administrator assumes 

that all diagnosed uterine cancers will 

be certified for treatment by the WTC 

Health Program. Finally, because there 

are no existing data on cancer rates 

related to 9/11 exposures at either the 

Pentagon or in Shanksville, 

Pennsylvania, the Administrator has 


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62 Yabroff KR, Lamont EB, Mariotto A, Warren JL, 

Topor M, Meekins A, Brown ML [2008], Cost of 

Care for Elderly Cancer Patients in the United 

States, J Natl Cancer Inst 100(9):630–41. 

63Surveillance, Epidemiology, and End Results 

(SEER) Program (www.seer.cancer.gov) SEER*Stat 

Database: Incidence—SEER 9 Regs Research Data, 

Nov 2020 Sub (1975–2018), National Cancer 

Institute, DCCPS, Surveillance Research Program, 

Surveillance Systems Branch, released Apr. 2021, 

based on the Nov. 2020 submission. Although 

patients who are Medicare members are age 65 and 

older, cancer treatment costs are not expected to 

vary with age. 

64Bureau of Labor Statistics, Consumer Price 

Index, https://fred.stlouisfed.org. Accessed on Apr. 

28, 2021. 

65See supra note 25. 

66 Jordan HT, Brackbill RM, Cone JE, 

Debchoudhury I, Farfel MR, Greene CM, Hadler JL, 

Kennedy J, Li J, Liff J, Stayner L, Stellman SD 

[2011], Mortality Among Survivors of the Sept 11, 

2001, Word Trade Center Disaster: Results from the 

World Trade Center Health Registry Cohort, Lancet 

378:879–887. Note: percentages may not sum to 100 

percent due to rounding. 

67Centers for Disease Control and Prevention, 

National Center for Health Statistics, Compressed 

Mortality File 1999–2016 on CDC WONDER Online 

Database, released June 2017. Data are from the 

Compressed Mortality File 1999–2016 Series 20 No. 

2U, 2016, as compiled from data provided by the 

57 vital statistics jurisdictions through the Vital 

Statistics Cooperative Program. http://

wonder.cdc.gov/cmf-icd10.html. Accessed May 29, 

2021. 

68Schubauer-Berigan MK, Hein MJ, Raudabaugh 

WM, Ruder AM, Silver SR, Spaeth S, Steenland K, 

Petersen MR, and Waters KM [2011], Update of the 

NIOSH Life Table Analysis System: A Person-Years 

Analysis program for the Windows Computing 

Environment, Am J Ind Med 54:915–924. 

69See supra note 62. 

70 Id. 

71Li J, Yung J, Qiao B, Takemoto E, Goldfarb DG, 

Zeig-Owens R, Cone JE, Brackbill RM, Farfel MR, 

Kahn AR, Schymura MJ, Shapiro MZ, Dasaro CR, 

Todd AC, Kristjansson D, Prezant DJ, Boffetta P, 

Hall CB [2021], Cancer Incidence in World Trade 

Center Rescue and Recovery Workers: 14 Years of 

Follow-Up, J Natl Cancer Inst https://doi.org/ 

10.1093/jnci/djab165. 

72The 23-year survival limit is imposed based on 

the analytic time horizon. 

used only data from studies of 

individuals who were responders or 

survivors in the New York City disaster 

area. 

Cost of Uterine Cancer Treatment 

The Administrator estimated the 

treatment costs associated with covering 

uterine cancer in this rulemaking. The 

costs of treatment are divided into three 

treatment phases: The first year of 

treatment following diagnosis; the 

intervening years or continuing 

treatment after the first year; and 

treatment during the last year of life. 

The first-year costs of cancer treatment 

are higher due to the initial need for 

aggressive medical care (e.g., radiation 

or chemotherapy) and surgical care. The 

costs during the last year of life are often 

dominated by increased hospitalization 

costs.62 Therefore, three different 

treatment phase costs were used to 

provide a best estimate of treatment 

costs in conjunction with expected 

incidence and long-term survival rates 

for uterine cancer. Average treatment 

costs for uterine cancer are in Table A, 

below. 

TABLE A—AVERAGE COSTS OF TREATMENT FOR UTERINE CANCER, 2021$ 

Stage of treatment: 

Initial (first 12 months after diagnosis) ................................. $39,638 

Continuing (annual) ................... 2,066 

Last year of life (last 12 months 

of life) ..................................... 118,058 

These cost figures were based on a 

study of cancer patients from the 

Surveillance, Epidemiology, and End 

Results (SEER) program maintained by 

the National Cancer Institute and using 

Medicare files.63 The average costs of 

treatment described above are given in 

2021 prices adjusted using the Medical 

Consumer Price Index for all urban 

consumers.64

Incident Cases of Cancer 

The Administrator estimated the 

expected number of cases of cancer that 

would be observed in a cohort of 

responders and survivors followed for 

cancer incidence after September 11, 

2001, using U.S. population cancer 

rates. Demographic characteristics of the 

cohort were assigned since the actual 

data are not available for individuals in 

the responder and survivor populations 

who have not yet enrolled in the WTC 

Health Program. Sex and age (at the time 

of exposure) distributions for 

responders and survivors were assumed 

to be the same as current members in 

the WTC Health Program. Because 

uterine cancer occurs only in females,65

all calculations only consider female 

WTC Health Program members. 

The Administrator assumed race and 

ethnic origin distributions for 

responders and survivors, respectively, 

according to distributions in the WTC 

Health Registry cohort: 66 57 percent 

non-Hispanic white, 15 percent nonHispanic black, 21 percent Hispanic, 

and 8 percent other race/ethnicity for 

responders; 50 percent non-Hispanic 

white, 17 percent non-Hispanic black, 

15 percent Hispanic, and 18 percent 

other race/ethnicity for survivors. 

Registry follow-up for cancer morbidity 

for each person began on January 1, 

2002, or age 15 years, whichever was 

later. Age 15 was considered because 

the cancer incidence rate file did not 

include rates for persons less than 15 

years of age. Follow-up ended on 

December 31, 2016, or the estimated last 

year of life, whichever was earlier. The 

estimated last year of life was used since 

not all persons would be expected to 

remain alive at the end of 2016. The 

estimated last year of life was based on 

U.S. gender, race, age, and year-specific 

death rates from CDC WONDER.67 A 

life-table analysis program, LTAS.NET, 

was used to estimate the expected 

number of incident cancers for uterine 

cancer.68 The Administrator calculated 

cancer incidence rates using data 

through 2018 from the SEER Program 

and estimated rates for 2002–2025.69

The Program applied the resulting 

gender, race, age, and year-specific 

cancer incidence rates to the estimated 

person-years at risk to estimate the 

expected number of cancer cases for 

uterine cancer starting from year 2002, 

the first full year following the 

September 11, 2001, terrorist attacks, to 

2025. 

Prevalence of Cancer 

To determine the potential number of 

persons in the responder and survivor 

populations with cancer, the 

Administrator used the number of 

incident uterine cancer cases described 

above for each year starting with 2002 

and estimated the prevalence of uterine 

cancer using survival rate statistics for 

each incident cancer group through 

2025.70 Using the incident cases and 

survival rate statistics, the 

Administrator estimated the prevalence 

(number of persons living with cancer) 

of cases during the 23-year period 

(2002–2025) since September 11, 2001. 

For the purposes of illustrating an upper 

bound incidence rate and prevalence 

estimate, the Administrator assumed 

that the rate of cancer in the WTC 

Health Program exceeds the general U.S. 

population rate by 21 percent due to 9/ 

11 exposures. The peer-reviewed 

literature supports the use of a 21 

percent excess risk of cancer in the 9/ 

11-exposed population over the U.S. 

population cancer rate; a 2021 study by 

Li et al.71 reported an adjusted hazard 

ratio of 1.21 (95 percent CI: 1.12, 1.31) 

for all cancer sites and used a withincohort comparison less affected by 

healthy worker selection bias. The 

resulting Table B summarizes those 

results for each year from 2022 through 

2025, the number of new cases 

occurring in that year (incidence), the 

number of persons surviving up to 23 

years beyond their first diagnosis 

(prevalence), and the number of 

individuals who might be expected to 

die from their cancer in that year.72


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Federal Register / Vol. 87, No. 90 / Tuesday, May 10, 2022 / Proposed Rules 27969 

73See OMB Circular A–94, Guidelines and 

Discount Rates for Benefit-Cost Analysis of Federal 

Programs. https://www.whitehouse.gov/sites/ 

whitehouse.gov/files/omb/circulars/A94/a094.pdf. 

74Sec. 3331(c)(3) of the PHS Act requires WTC 

Health Program members to maintain minimum 

essential insurance coverage. 

TABLE B—ESTIMATED INCIDENCE AND PREVALENCE OF UTERINE CANCER

[2022–2025] 

2022 2023 2024 2025 

Responders (based on ∼10,000 female members) 

New cases ....................................................................................................... 6.69 6.92 7.14 7.27 

Live cases from previous years ....................................................................... 29.46 30.78 32.09 33.33 

Deaths .............................................................................................................. 5.09 5.37 5.61 5.90 

Total cases ............................................................................................... 36.15 37.70 39.23 40.60 

Survivors (based on ∼16,000 female members) 

New cases ....................................................................................................... 10.91 10.91 10.91 10.91 

Live cases from previous years ....................................................................... 53.70 54.72 55.49 56.17 

Deaths .............................................................................................................. 9.60 9.90 10.17 10.31 

Total cases ............................................................................................... 64.61 65.63 66.40 67.08 

Total (based on ∼26,000 female WTC responder and survivor members) 

New cases ....................................................................................................... 17.6 17.83 18.05 18.18 

Live cases from previous years ....................................................................... 83.16 85.50 87.58 89.50 

Deaths .............................................................................................................. 14.69 15.27 15.78 16.21 

Total cases ............................................................................................... 100.76 103.33 105.63 107.68 

Cost Computation 

To compute the costs for uterine 

cancer, the Administrator assumes that 

the individuals diagnosed with uterine 

cancer will be certified by the WTC 

Health Program for treatment and 

monitoring services. The treatment costs 

for the first year of treatment (Table A, 

year adjusted) were applied to the 

predicted newly incident (Year 1) cases 

for each year. Likewise, the costs of 

treatment for the last year of life were 

applied in each year to the number of 

people predicted to die from their 

cancer in that year. The costs of 

continuing treatment from Table A were 

applied to the number of prevalent cases 

who had survived their cancers beyond 

their year of diagnosis, for each year of 

survival (Year 2–23). 

The estimated treatment costs for 

responders and survivors were recomputed under the following two 

assumptions: (1) The rate of cancer in 

the WTC Health Program is equal to the 

rate of cancer observed in the general 

U.S. population; and (2) the rate of 

cancer in the WTC Health Program 

exceeds the general U.S. population rate 

by 21 percent, as discussed above. Costs 

for future years are discounted at both 

7 percent and 3 percent to reflect net 

present value.73

The sum of the annual costs in the 

table for the years 2022 through 2025 

represents the estimated treatment costs 

to the WTC Health Program for coverage 

of uterine cancer for the 12 percent of 

approximately 82,000 WTC responders 

who are female and the 50 percent of 

approximately 32,000 WTC survivors 

who are female. 

Summary of Costs 

Because HHS lacks data to account for 

recoupment from workers’ 

compensation insurance or primary 

payment by either private health 

insurance or Medicare/Medicaid 

payments, the estimates offered here are 

reflective of estimated WTC Health 

Program costs only and assume the 

Program is the primary payer. This 

analysis offers an assumption about the 

number of individuals who might enroll 

in the WTC Health Program and 

estimates the impact of both a low rate 

of cancer (U.S. population average rate) 

and an increased rate (21 percent greater 

than the U.S. population average) on the 

number of cases and the resulting 

estimated treatment costs to the WTC 

Health Program. This analysis does not 

include administrative costs associated 

with certifying additional WTC-related 

uterine cancers that might result from 

this action. 

Since the implementation of 

provisions of the Affordable Care Act on 

January 1, 2014, all members and future 

members are assumed to have or have 

access to medical insurance coverage 

other than through the WTC Health 

Program.74 Therefore, all treatment costs 

to be paid by the WTC Health Program 

from 2022 through 2025 are considered 

transfers. 

TABLE C—MEDICAL TREATMENT COST FOR UTERINE CANCER CASES DURING 2022–2025, 2021$ 

2022 costs, undiscounted, 2021$ 2023–2025 2023–2025 

costs,* 7% costs, 3% 

discount rate discount rate 

Cancer rate Cancer rate 

U.S. average U.S. average + 21% U.S. average U.S. average + 21% 

Responders .............................................................................. $749,741 $907,187 $2,145,844 $2,801,474


lotter on DSK11XQN23PROD with PROPOSALS1
27970 Federal Register / Vol. 87, No. 90 / Tuesday, May 10, 2022 / Proposed Rules 

75 Goldfarb DG, Zeig-Owens R, Kristjansson D, Li 

J, Brackbill RM, Farfel MR, Cone JE, Kahn AR, Qiao 

B, Schymura MJ, Webber MP, Dasaro CR, Lucchini 

RG, Todd AC, Prezant DJ, Hall CB, Boffetta P [2021], 

Cancer Survival among World Trade Center Rescue 

and Recovery Workers: A Collaborative Cohort 

Study, Am J Ind Med 64(10):815–826. 

76Wharam JF, Galbraith AA, Kleinman KP, 

Soumerai SB, Ross-Degnan D, Landon BE [2008], 

Cancer Screening before and after Switching to a 

High-Deductible Health Plan, Ann Intern Med 

148(9):647–655. 

TABLE C—MEDICAL TREATMENT COST FOR UTERINE CANCER CASES DURING 2022–2025, 2021$—Continued 

Survivors .................................................................................. 1,067,098 1,291,189 2,912,084 3,799,381 

Total .................................................................................. 1,816,839 2,198,376 5,057,928 6,600,855 

* Since this table summarizes the lowest and highest cost estimates for treatment of uterine cancer, values representing 2023–2025 costs at 

the 7% discount rate and at the increased cancer rate and 2023–2025 costs at the 3% discount rate and at the U.S. population average rate 

were not included. 

The Administrator found the cost 

estimate range by adding the low 2023– 

2025 estimate in Table C (7 percent 

discount rate, U.S. cancer rate average) 

and the low estimate for 2022 (U.S. 

cancer rate average) and dividing the 

sum by four to find the annual low-cost 

estimate (i.e., $1,718,691). The same 

calculation was done for the annual 

high-cost estimates, adding the higher 

numbers in Table C (3 percent discount 

rate, U.S. cancer rate average +21 

percent) to the high estimate for 2022 

(U.S. cancer rate average +21 percent) 

and dividing the sum by four (i.e., 

$2,199,808). 

Examination of Benefits (Health Impact) 

This section qualitatively describes 

the potential benefits of this rulemaking 

to add uterine cancer to the List of 

WTC-Related Health Conditions in 

terms of the expected improvements in 

the health and health-related quality of 

life of potential uterine cancer patients 

treated through the WTC Health 

Program, compared to not conducting 

the rulemaking. 

The Administrator does not have 

information on the health of the 

population that may have experienced 

9/11 exposures and is not currently 

enrolled in the WTC Health Program. In 

addition, the Administrator has only 

limited information about health 

insurance and healthcare services for 

uterine cancers potentially caused by 9/ 

11 exposures and suffered by any 

population of responders and survivors, 

including responders and survivors 

currently enrolled in the WTC Health 

Program and responders and survivors 

not enrolled in the Program. For the 

purposes of this analysis, the 

Administrator assumes that all 

unenrolled responders and survivors are 

now covered by health insurance due to 

access provided by the Affordable Care 

Act and may be receiving treatment 

outside the WTC Health Program. 

Although the Administrator cannot 

quantify the benefits associated with the 

WTC Health Program, members with 

uterine cancer are expected to 

experience better treatment outcomes as 

Program members than non-members. A 

recent study found that ‘‘WTC-exposed 

responder cancer patients enrolled in 

the MMTP [WTC Medical Monitoring 

and Treatment Program, a predecessor 

to the WTC Health Program] had higher 

survival rates compared with those not 

enrolled in the MMTP.’’ 75 Moreover, 

under other insurance plans, patients 

would have deductibles and copays, 

which impact access to care and, 

particularly, its timeliness.76 WTC 

Health Program members have firstdollar coverage and hence are likely to 

seek care sooner, when indicated, 

resulting in improved treatment 

outcomes. 

Finally, during public meetings, 

Program members have expressed that 

the lack of social and clinical support, 

and lack of recognition that their 

diagnosed uterine cancer is a WTCrelated health condition, have had a 

significant negative impact on their 

morale and quality of life. 

Limitations 

The analysis presented here was 

limited by the dearth of verifiable data 

on the uterine cancer status of 

responders and survivors who have yet 

to apply for enrollment in the WTC 

Health Program. Because of the limited 

data, the Administrator was not able to 

estimate benefits in terms of averted 

healthcare costs; nor was the 

Administrator able to estimate 

administrative costs, or indirect costs, 

such as averted absenteeism, short- and 

long-term disability, and productivity 

losses averted due to premature 

mortality. 

B. Regulatory Flexibility Act 

The Regulatory Flexibility Act (RFA), 

5 U.S.C. 601 et seq., requires each 

agency to consider the potential impact 

of its regulations on small entities, 

including small businesses, small 

governmental units, and small not-forprofit organizations. The Administrator 

certifies that this proposed rule has ‘‘no 

significant economic impact upon a 

substantial number of small entities’’ 

within the meaning of the RFA. 

C. Paperwork Reduction Act 

The Paperwork Reduction Act (PRA), 

44 U.S.C. 3501 et seq., requires an 

agency to invite public comment on, 

and to obtain OMB approval of, any 

regulation that requires 10 or more 

people to report information to the 

agency or to keep certain records. The 

Administrator has determined that this 

rulemaking does not contain any new 

information collection requirements or 

recordkeeping requirements; thus, the 

PRA does not apply to this rulemaking. 

Data collection and recordkeeping 

requirements for the WTC Health 

Program are approved by OMB under 

‘‘World Trade Center Health Program 

Enrollment, Appeals & Reimbursement’’ 

(OMB Control No. 0920–0891, exp. 

December 31, 2021, currently under 

OMB review). 

D. Small Business Regulatory 

Enforcement Fairness Act 

As required by Congress under the 

Small Business Regulatory Enforcement 

Fairness Act of 1996, 5 U.S.C. 801 et 

seq., HHS will report the promulgation 

of this rule to Congress prior to its 

effective date. 

E. Unfunded Mandates Reform Act of 

1995 

Title II of the Unfunded Mandates 

Reform Act of 1995, 2 U.S.C. 1531 et 

seq., directs agencies to assess the 

effects of Federal regulatory actions on 

state, local, and tribal governments, and 

the private sector ‘‘other than to the 

extent that such regulations incorporate 

requirements specifically set forth in 

law.’’ For purposes of the Unfunded 

Mandates Reform Act, this proposed 

rule does not include any Federal 

mandate that may result in increased 

annual expenditures in excess of $100 

million in 1995 dollars by state, local, 

or tribal governments in the aggregate, 

or by the private sector. 

F. Executive Order 12988 (Civil Justice) 

This proposed rule has been drafted 

and reviewed in accordance with 

Executive Order 12988, ‘‘Civil Justice 

Reform,’’ and will not unduly burden 

the Federal court system. This rule has 


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Federal Register / Vol. 87, No. 90 / Tuesday, May 10, 2022 / Proposed Rules 27971 

1Advance notice of proposed rulemaking— 

Carrier Automated Tariffs, 86 FR 18240 (April 8, 

2021). 

been reviewed carefully to eliminate 

drafting errors and ambiguities. 

G. Executive Order 13132 (Federalism) 

The Administrator has reviewed this 

proposed rule in accordance with 

Executive Order 13132 regarding 

federalism and has determined that it 

does not have ‘‘Federalism 

implications.’’ The rule does not ‘‘have 

substantial direct effects on the states, 

on the relationship between the national 

government and the states, or on the 

distribution of power and 

responsibilities among the various 

levels of government.’’ 

H. Executive Order 13045 (Protection of 

Children From Environmental Health 

Risks and Safety Risks) 

In accordance with Executive Order 

13045, the Administrator has evaluated 

the environmental health and safety 

effects of this proposed rule on children. 

The Administrator has determined that 

the rule would have no environmental 

health and safety effect on children. 

I. Executive Order 13211 (Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use) 

In accordance with Executive Order 

13211, the Administrator has evaluated 

the effects of this proposed rule on 

energy supply, distribution, or use, and 

has determined that the rule will not 

have a significant adverse effect. 

J. Plain Writing Act of 2010 

Under Public Law 111–274 (October 

13, 2010), Executive Departments and 

Agencies are required to use plain 

language in documents that explain to 

the public how to comply with a 

requirement the Federal Government 

administers or enforces. The 

Administrator has attempted to use 

plain language in promulgating the 

proposed rule consistent with the 

Federal Plain Writing Act guidelines 

and requests public comment on this 

effort. 

List of Subjects in 42 CFR Part 88 

Aerodigestive disorders, Appeal 

procedures, Cancer, Healthcare, Mental 

health conditions, Musculoskeletal 

disorders, Respiratory and pulmonary 

diseases. 

For the reasons discussed in the 

preamble, the Administrator and HHS 

Secretary propose to amend 42 CFR part 

88 as follows: 

PART 88—WORLD TRADE CENTER 

HEALTH PROGRAM 

■ 1. The authority citation for part 88 is 

revised to read as follows: 

Authority: 42 U.S.C. 300mm to 300mm–61. 

■ 2. Amend § 88.15 as follows: 

■ a. Redesignate paragraphs (d)(15) 

through (24) as paragraphs (d)(16) 

through (25). 

■ b. Add new paragraph (d)(15). 

■ c. In newly redesignated paragraph 

(d)(24), remove ‘‘Childhood cancers:’’ 

and add ‘‘Childhood cancers:’’ in its 

place. 

■ d. In newly redesignated paragraph 

(d)(25), remove ‘‘Rare cancers:’’ and add 

‘‘Rare cancers:’’ in its place. 

The addition reads as follows: 

§ 88.15 List of WTC-Related Health 

Conditions. 

* * * * * 

(d) * * * 

(15) Malignant neoplasms of corpus 

uteri and uterus, part unspecified. 

* * * * * 

John J. Howard, 

Administrator, World Trade Center Health 

Program and Director, National Institute for 

Occupational Safety and Health, Centers for 

Disease Control and Prevention, Department 

of Health and Human Services. 

Xavier Becerra, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2022–09708 Filed 5–9–22; 8:45 am] 

BILLING CODE 4163–18–P 

FEDERAL MARITIME COMMISSION 

46 CFR Part 520 

[Docket No. 21–03] 

RIN 3072–AC86 

Carrier Automated Tariffs 

AGENCY: Federal Maritime Commission. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: The Federal Maritime 

Commission (Commission) is seeking 

public comment on proposed 

modifications to its rules governing 

Carrier Automated Tariffs through this 

notice of proposed rulemaking (NPRM). 

The proposed rule would remove the 

option for ocean common carriers to 

charge a fee to access their tariff; allow 

non-vessel operating common carriers 

(NVOCCs) to cross reference certain 

aspects of other carriers’ terms in their 

tariffs; clarify the ability for NVOCCs to 

reflect increases in certain charges 

passed-through by other entities without 

notice; update the definition of coloading to apply only to less than 

container loads; require that 

documentation be annotated with the 

names of all NVOCCs involved in a 

shipping transaction; and make other 

miscellaneous updates and 

clarifications to the regulation. 

DATES: Submit comments on or before 

June 9, 2022. 

ADDRESSES: You may submit comments 

by email to secretary@fmc.gov. For 

comments, include in the subject line: 

‘‘Docket No. 21–03, Comments on 

Carrier Automated Tariffs Rulemaking.’’ 

Comments should be attached to the 

email as a Microsoft Word or textsearchable PDF document. 

Instructions: For detailed instructions 

on submitting comments, including 

requesting confidential treatment of 

comments, and additional information 

on the rulemaking process, see the 

Public Participation heading of the 

Supplementary Information section of 

this document. Note that all comments 

received will be posted without change 

to the Commission’s website unless the 

commenter has requested confidential 

treatment. 

Docket: For access to the docket to 

read background documents or 

comments received, go to the 

Commission’s Electronic Reading Room 

at: https://www2.fmc.gov/readingroom/ 

proceeding/21-03/. 

FOR FURTHER INFORMATION CONTACT: 

William Cody, Secretary; Phone: (202) 

523–5725; Email: secretary@fmc.gov. 

SUPPLEMENTARY INFORMATION: 

I. Discussion 

On April 8, 2021, the Commission 

issued an Advance Notice of Proposed 

Rulemaking (ANPRM) seeking 

information on how common carriers 

interpret and apply certain Commission 

regulations in 46 CFR part 520.1 In 

response to the ANPRM, the 

Commission received three sets of 

comments from interested parties: The 

National Customs Brokers and 

Forwarders Association of America, Inc 

(NCBFAA); New York New Jersey 

Foreign Freight Forwarders & Brokers 

Association, Inc. (NYNJFFF&BA); and 

the Association of Food Industries, Inc. 

(AFI). NCBFAA and NYNJFFF&BA are 

trade associations whose members 

include non-vessel operating common 

carriers (NVOCCs), and AFI is a trade 

association for the U.S. food import 

industry. These comments are 

addressed later in this proposed rule. 

A. Tariff Access Fees 

Before the passage of the Ocean 

Shipping Reform Act of 1998 (OSRA), 

which became effective May 1, 1999, 

vessel operating common carrier 

(VOCC) and conference tariffs were filed 


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