7698 Federal Register / Vol. 90, No. 13 / Wednesday, January 22, 2025 / Notices 

1Title XXXIII of the PHS Act is codified at 42 

U.S.C. 300mm to 300mm–64. Those portions of the 

James Zadroga 9/11 Health and Compensation Act 

of 2010 found in Titles II and III of Public Law 111– 

347 do not pertain to the WTC Health Program and 

are codified elsewhere. 

2The List of WTC-Related Health Conditions is 

established in 42 U.S.C. 300mm–22(a)(3)–(4) and 

300mm–32(b); additional conditions may be added 

through rulemaking and the complete list is 

provided in WTC Health Program regulations at 42 

CFR 88.15. 

Original threshold 2025 Adjusted threshold 

$100 million .............................................................................................. $252.9 million. 

$110 million .............................................................................................. $278.2 million. 

$200 million .............................................................................................. $505.8 million. 

$500 million .............................................................................................. $1.264 billion. 

$1 billion ................................................................................................... $2.529 billion. 

(2) The Filing Fee Thresholds 

Section 605 of Public Law 101–162 

(15 U.S.C. 18a note) requires the Federal 

Trade Commission to assess and collect 

filing fees from persons acquiring voting 

securities or assets under the Act. The 

original filing fee thresholds are set 

forth in section 605. Division GG of the 

2023 Consolidated Appropriations Act, 

Public Law 117–328, 136 Stat. 4459, 

requires the Federal Trade Commission 

to revise these filing fee thresholds and 

amounts based on the percentage 

change in the GNP for such fiscal year 

compared to the GNP for the year 

ending September 30, 2022 (for the 

filing fee thresholds) and the percentage 

increase, if any, in the Consumer Price 

Index, as determined by the Department 

of Labor or its successor, for the year 

then ended over the level so established 

for the year ending September 30, 2022 

(for the fee amounts). 

Any reference to the fee thresholds 

and related values in the HSR rules (16 

CFR parts 801 through 803) and the HSR 

Form and its Instructions will also be 

adjusted, where indicated by the term 

‘‘(as adjusted)’’, as follows: 

Original 

filing fee Original applicable size of transaction * 2025 Adjusted filing fee 2025 Adjusted applicable size of transaction * 

$30,000 less than $161.5 million. $30,000 less than $179.4 million. 

100,000 not less than $161.5 million but less than $500 million. 105,000 not less than $179.4 million but less than $555.5 

million. 

250,000 not less than $500 million but less than $1 billion. 265,000 not less than $555.5 million but less than $1.111 billion. 

400,000 not less than $1 billion but less than $2 billion. 425,000 not less than $1.111 billion but less than $2.222 billion. 

800,000 not less than $2 billion but less than $5 billion. 850,000 not less than $2.222 billion but less than $5.555 billion. 

2,250,000 $5 billion or more. 2,390,000 $5.555 billion or more. 

* As determined under Section 7A(a)(2) of the Act. 

By direction of the Commission. 

April Tabor, 

Secretary. 

[FR Doc. 2025–01518 Filed 1–21–25; 8:45 am] 

BILLING CODE 6750–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[NIOSH Docket 094] 

World Trade Center Health Program; 

Petitions 031, 036, 039, and 053— 

Amyotrophic Lateral Sclerosis; Finding 

of Insufficient Evidence 

AGENCY: Centers for Disease Control and 

Prevention, Health and Human Services 

(HHS). 

ACTION: Denial of petitions for addition 

of a health condition. 

SUMMARY: The Administrator of the 

World Trade Center (WTC) Health 

Program received four petitions 

(Petitions 031, 036, 039, and 053) to add 

amyotrophic lateral sclerosis (ALS) to 

the List of WTC-Related Health 

Conditions (List). Upon reviewing the 

scientific and medical literature, 

including information provided by 

petitioners, the Administrator 

determined that there is insufficient 

evidence to support taking further 

action at this time regarding ALS. The 

Administrator also finds that 

insufficient evidence exists to request a 

recommendation of the WTC Health 

Program Scientific/Technical Advisory 

Committee (STAC), to publish a 

proposed rule, or to publish a 

determination not to publish a proposed 

rule. 

DATES: The Administrator of the WTC 

Health Program is denying these 

petitions for the addition of a health 

condition as of January 22, 2025. 

ADDRESSES: Visit the WTC Health 

Program website at https://

www.cdc.gov/wtc/received.html to 

review Petitions 031, 036, 039, and 053. 

FOR FURTHER INFORMATION CONTACT: 

Rachel Weiss, Program Analyst, 1090 

Tusculum Avenue, MS: C–48, 

Cincinnati, OH 45226; telephone (404) 

498–2500 (this is not a toll-free 

number); email NIOSHregs@cdc.gov. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

A. WTC Health Program Statutory Authority 

B. Procedures for Evaluating a Petition 

C. Petitions 031, 036, 039, and 053 

D. Review of Scientific Evaluation 

E. Administrator’s Final Decision on Whether 

To Propose the Addition of Amyotrophic 

Lateral Sclerosis to the List 

F. Approval to Submit Document to the 

Office of the Federal Register 

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, Pub. L. 116–59, Pub. L. 

117–328, and Pub. L. 118–31), added 

Title XXXIII to the Public Health 

Service (PHS) Act,1 thereby establishing 

the WTC Health Program within HHS. 

The WTC Health Program provides 

medical monitoring and treatment 

benefits for health conditions on the 

List 2 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 


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Federal Register / Vol. 90, No. 13 / Wednesday, January 22, 2025 / Notices 7699 

3See 42 U.S.C. 300mm–5(7); 42 CFR 88.1. 

4See WTC Health Program [2014], Policy and 

Procedures for Handling Submissions and Petitions 

to Add a Health Condition to the List of WTCRelated Health Conditions, May 14, 2014, http://

www.cdc.gov/wtc/pdfs/WTCHPPPPetitionHandling

Procedures14May2014.pdf. 

5See WTC Health Program [2024], Policy and 

Procedures for Adding Non-Cancer Conditions to 

the List of WTC-Related Health Conditions, October 

18, 2024, https://www.cdc.gov/wtc/pdfs/policies/ 

WTCHP_PP_Adding_NonCancer_Health_

Conditions_20241018.pdf. 

6 Id. at 6. 

7Hill AB [1965], The Environment and Disease: 

Association or Causation? Proc R Soc Med 

58(5):295–300. According to the Policy and 

Procedures for Adding Non-Cancer Conditions to 

the List of WTC-Related Health Conditions, the 

‘‘Bradford Hill criteria are a leading weight of 

evidence framework which comprises nine aspects 

of association. These aspects comprise strength of 

association, consistency, specificity, temporality, 

biological gradient, plausibility, coherence, 

experiment, and analogy.’’ See supra note 5 at 9, 

footnote 21. 

8Substantial likelihood of causal association 

means that the association is strongly supported by 

evidence from high-quality, peer-reviewed, 

published epidemiologic studies of the health 

condition in 9/11-exposed populations and there is 

high confidence that the association cannot be 

explained by chance, bias, confounding, or any 

other alternative explanation. See supra note 5 at 

12. 

9High likelihood of causal association means that 

the scientific evidence, taken as a whole, 

demonstrates that the likelihood of a causal 

association is less than substantial, but definitively 

more than limited. Therefore, there is some 

meaningful likelihood that the association can be 

explained by chance, bias, confounding, or another 

alternative explanation. See supra note 5 at 12. 

New York City, at the Pentagon, and in 

Shanksville, Pennsylvania (responders). 

The Program also provides benefits 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 3 (survivors). 

All references to the Administrator of 

the WTC Health Program 

(Administrator) in this document mean 

the Director of the National Institute for 

Occupational Safety and Health 

(NIOSH) or his designee. 

Pursuant to section 3312(a)(6)(B) of 

the PHS Act, interested parties may 

petition the Administrator to add a 

health condition to the List in 42 CFR 

88.15. Within 90 days after receipt of a 

valid petition to add a condition to the 

List, the Administrator must take one of 

the following four actions described in 

section 3312(a)(6)(B) of the PHS Act and 

§ 88.16(a)(2) of the WTC Health Program 

regulations: (1) Request a 

recommendation of the STAC; (2) 

publish a proposed rule in the Federal 

Register to add such health condition; 

(3) publish in the Federal Register the 

Administrator’s determination not to 

publish such a proposed rule and the 

basis for such determination; or (4) 

publish in the Federal Register a 

determination that insufficient evidence 

exists to take action under (1) through 

(3) above. 

More information about the WTC 

Health Program, including the List and 

the petition process, is available at 

www.cdc.gov/wtc/. 

B. Procedures for Evaluating a Petition 

In addition to the regulatory 

provisions, the WTC Health Program 

has developed policies to guide the 

review of submissions and petitions,4 as 

well as the evaluation of evidence 

supporting the potential addition of a 

non-cancer health condition to the List.5

A valid petition must include 

sufficient medical basis for the 

association between the September 11, 

2001, terrorist attacks and the health 

condition to be added. In accordance 

with WTC Health Program Policy and 

Procedures for Handling Submissions 

and Petitions to Add a Health Condition 

to the List of WTC-Related Health 

Conditions, reference to a peerreviewed, published, epidemiologic 

study about the health condition among 

9/11-exposed populations or to clinical 

case reports of health conditions in 

WTC responders or survivors may 

demonstrate the required medical basis. 

In accordance with 42 CFR 88.16(a)(5), 

the Administrator is required to 

consider a new petition for a previouslyevaluated health condition determined 

not to qualify for addition to the List 

only if the new petition presents a new 

medical basis for the association 

between 9/11 exposures and the 

condition to be added. A new medical 

basis is evidence not previously 

reviewed by the Administrator. 

After the Program has determined that 

a petition is valid, and in accordance 

with the Policy and Procedures for 

Adding Non-Cancer Conditions to the 

List of WTC-Related Health Conditions 

(Policy and Procedures), the 

Administrator directs the WTC Health 

Program Science Team (Science Team) 

to conduct a review of the scientific 

literature to determine if the available 

scientific information has the potential 

to provide a basis for a decision on 

whether to add the health condition to 

the List.6 The literature review is a 

keyword search of relevant scientific 

databases intended to identify peerreviewed, published, epidemiologic 

studies about the health condition 

among 9/11-exposed populations. 

Using validity indicators detailed in 

the Policy and Procedures, the Science 

Team evaluates the scientific quality of 

each peer-reviewed, published, 

epidemiologic study of the health 

condition that exhibits the potential to 

provide a basis for deciding whether to 

propose adding the health condition to 

the List identified in the literature 

search. The Science Team then 

evaluates the studies, individually and 

together, to characterize the evidence of 

a causal association between 9/11 

exposures and the health condition. The 

Science Team’s evaluation includes 

consideration of the Bradford Hill 

weight of evidence criteria,7 study 

limitations, and whether the studies are 

representative of the 9/11-exposed 

population of responders and survivors. 

After assessing the degree to which the 

evidence supports a causal association 

between 9/11 exposures and the health 

condition, the Science Team will assign 

the evidence to one of the following five 

categories: 

(1) substantial likelihood of causal 

association, 

(2) high likelihood of causal 

association, 

(3) limited likelihood of causal 

association, 

(4) no likelihood of causal association, 

or 

(5) inadequate evidence to determine 

the likelihood of causal association. 

The Science Team provides the 

outcome of its evaluation to the 

Administrator. A health condition may 

be added to the List if peer-reviewed, 

published, epidemiologic studies 

provide support that there is a 

substantial likelihood of a causal 

association between the health 

condition and 9/11 exposures (Category 

1).8 If the evaluation of evidence 

provided in peer-reviewed, published, 

epidemiologic studies of the health 

condition in 9/11 populations 

demonstrates a high, but not substantial, 

likelihood of a causal association 

between the 9/11 exposures and the 

health condition (Category 2),9 then the 

Administrator may consider additional 

highly relevant scientific evidence 

regarding exposures to 9/11 agents in 

non-9/11 exposure scenarios. If that 

additional assessment establishes that 

there is now sufficient evidence to 

support the conclusion that a causal 

association between the 9/11 exposures 

and the health condition is substantially 

likely among 9/11-exposed populations 

(Category 1), the health condition may 

be proposed for addition to the List. 

More information about the WTC 

Health Program, including the List and 

the petition process, is available at 

www.cdc.gov/wtc/. 


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7700 Federal Register / Vol. 90, No. 13 / Wednesday, January 22, 2025 / Notices 

10See Petition 031, WTC Health Program: 

Petitions Received, http://www.cdc.gov/wtc/ 

received.html. 

11Schulte PA, Burnett CA, Boeniger MF, Johnson 

J [1996], Neurodegenerative Diseases: Occupational 

Occurrence and Potential Risk Factors, 1982 

through 1991, Am J Public Health 86(9):1281–8. 

12 Genuis SJ and Kelln KL [2015], Toxicant 

Exposure and Bioaccumulation: A Common and 

Potentially Reversible Cause of Cognitive 

Dysfunction and Dementia, Behav Neurol 

2015:620143. 

13Beard JD and Kamel F [2015], Military Service, 

Deployments, and Exposures in Relation to 

Amyotrophic Lateral Sclerosis Etiology and 

Survival, Epidemiol Rev 37(1):55–70. 

14See Petition 039, WTC Health Program: 

Petitions Received, http://www.cdc.gov/wtc/ 

received.html. 

15NB: The petition numbers are out of order 

because the WTC Health Program processed the 

second submission first. 

16Weisskopf MG, Morozova N, O’Reilly EJ, 

McCullough ML, Calle EE, Thun MJ, Ascherio A 

[2009], Prospective Study of Chemical Exposures 

and Amyotrophic Lateral Sclerosis, J Neurol 

Neurosurg Psychiatry 80(5):558–61. 

17See Petition 053, WTC Health Program: 

Petitions Received, http://www.cdc.gov/wtc/ 

received.html. 

18The complete list of search terms is as follows: 

amyotrophic lateral sclerosis, motor neuron disease, 

motor neuron syndrome, lateral sclerosis, Lou 

Gehrig’s disease, neurodegenerative disorder, 

amyotrophy, progressive muscular atrophy, ALS, 

and motor neuropathy. The following databases 

were searched: APA PsycInfo®, CINAHL 

(EBSCOhost), Embase Classic+Embase, Health & 

Safety Science Abstracts (ProQuest), NIOSHTIC–2, 

Ovid MEDLINE®, Scopus, and Toxicology Abstracts 

(ProQuest). 

19All six of the studies examined mortality 

patterns in the 9/11-exposed population using 

composite outcomes that included ALS along with 

other disorders of the nervous system and sensory 

organs. The six studies all used composite 

outcomes grouped together in the ‘‘NIOSH–119 

Death Categories and Corresponding International 

Classification of Disease Codes for 1960 through 

2004,’’ available at https://www.cdc.gov/niosh/ltas/ 

pdf/Rate-Info-Table-1.pdf. Diseases of the nervous 

system and sense organs, categorized by NIOSH as 

‘‘Major 15,’’ includes such health conditions as 

ALS, Parkinson’s disease, hereditary and idiopathic 

neuropathy, and many other nervous system 

disorders. 

C. Petitions 031, 036, 039, and 053 

The Administrator of the WTC Health 

Program received four petitions 

requesting the addition of amyotrophic 

lateral sclerosis to the List of WTCRelated Health Conditions between 

2021 and 2024. Of the scientific 

references provided in each petition, six 

were found to meet the validity 

requirement of being peer-reviewed, 

published, epidemiologic studies about 

the health condition among 9/11- 

exposed populations or to clinical case 

reports of health conditions in WTC 

responders or survivors. Each petition 

and its medical basis is described 

below. 

On July 12, 2021, the Administrator 

received a petition (Petition 031) from a 

WTC responder requesting the addition 

of ‘‘Amyotrophic Lateral Sclerosis 

(ALS)’’ to the List.10 The petition’s 

validity was established by references to 

three peer-reviewed, published, 

epidemiologic studies that demonstrate 

a medical basis for the association 

between 9/11 exposures and ALS. The 

referenced studies and literature 

reviews each individually establishing a 

medical basis are as follows: 

• Neurodegenerative Diseases: 

Occupational Occurrence and Potential 

Risk Factors, 1982 through 1991, by 

Schulte et al. [1996],11 is a peerreviewed, published case-control study 

of occupational exposures and 

neurodegenerative diseases, including 

ALS, using death certificate data in a 

national mortality surveillance database. 

• Toxicant Exposure and 

Bioaccumulation: A Common and 

Potentially Reversible Cause of 

Cognitive Dysfunction and Dementia, by 

Genuis and Kelln [2015],12 is a peerreviewed, published review article of 

the literature on bioaccumulation 

following exposure to toxicants, some of 

which are 9/11 agents, and increased 

risk of cognitive dysfunction and 

dementia resulting from 

neurodegenerative diseases including 

ALS. 

• Military Service, Deployments, and 

Exposures in Relation to Amyotrophic 

Lateral Sclerosis Etiology and Survival, 

by Beard and Kamel [2015],13 is a peerreviewed, published review of the 

evidence associating ALS and motor 

neuron diseases (MNDs) with military 

service, deployments, and exposures, 

from peer-reviewed epidemiologic 

studies published through 2013. These 

three studies suggest a potential 

association between exposure to 9/11 

agents (specifically experiences that 

might cause psychological harm, 

physical hazards, and chemical hazards, 

including heavy metals) and ALS, and 

thus provided a sufficient medical basis 

to consider the submission a valid 

petition. 

On April 7, 2022, the Administrator 

received a petition (Petition 039), 

requesting the addition of 

‘‘Amyotrophic Lateral Sclerosis (ALS), 

Lou Gehrig’s disease,’’ to the List.14 A 

second petition (Petition 036), 

submitted by the same petitioner, was 

received by the Administrator on April 

14, 2022.15 The petitions’ validity was 

established by references to one peerreviewed, published, epidemiologic 

study that demonstrates a positive 

association between 9/11 exposures and 

ALS: 

• Prospective study of chemical 

exposures and amyotrophic lateral 

sclerosis, by Weisskopf et al. [2009],16 is 

a peer-reviewed, published prospective 

cohort study of the relationship between 

exposure to chemicals, including 

formaldehyde (a 9/11 agent), and ALS in 

over 1 million cancer prevention study 

participants. 

This study suggests a potential 

association between exposure to 

formaldehyde, a 9/11 agent, and ALS, 

and thus provided a sufficient medical 

basis to consider the submission a valid 

petition. 

On January 30, 2024, the 

Administrator received a petition 

(Petition 053), requesting the addition of 

‘‘Amyotrophic Lateral Sclerosis (ALS)’’ 

to the List.17 The petition’s validity was 

established by references to two peerreviewed, published, epidemiologic 

studies that demonstrate a medical basis 

for the association between 9/11 

exposures and ALS. The studies 

establishing a medical basis are as 

follows: 

• Occupational Exposures and 

Neurodegenerative Diseases—A 

Systematic Literature Review and MetaAnalyses, by Gunnarsson and Bodin 

[2019], is a peer-reviewed, published 

review article discussing the links 

between occupational exposures and 

neurodegenerative diseases. 

• Blood Metal Levels and 

Amyotrophic Lateral Sclerosis Risk: A 

Prospective Cohort, by Peters et al. 

[2021], is a prospective cohort study 

comparing metal levels in blood 

samples for ALS patients and controls, 

to investigate whether metals such as 

arsenic, cadmium, copper, and lead are 

associated with ALS mortality. 

These studies suggest a potential 

association between cadmium, lead, and 

zinc and ALS, and thus provided a 

sufficient medical basis to consider the 

submission a valid petition. 

D. Review of Scientific Evaluation 

In response to Petitions 031, 036, 039, 

and 053, and pursuant to the Policy and 

Procedures, the WTC Health Program 

conducted a systematic literature search 

to identify peer-reviewed, published, 

epidemiologic studies of ALS or motor 

neuron disease (MND) in 9/11-exposed 

populations.18

The literature search conducted by 

the WTC Health Program found no 

studies that directedly examined ALS or 

MND risk in the 9/11-exposed 

population. However, the search 

identified six peer-reviewed, published, 

epidemiologic studies of mortality from 

nervous systems disorders, including 

ALS 19 in 9/11-exposed populations: 

• A 15-Year Follow-Up Study of 

Mortality in a Pooled Cohort of World 

Trade Center Rescue and Recovery 


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Federal Register / Vol. 90, No. 13 / Wednesday, January 22, 2025 / Notices 7701 

20Li J, Hall CB, Yung J, Kehm RD, Zeig-Owens 

R, Singh A, Cone JE, Brackbill RM, Farfel MR, Qiao 

B, Schymura MJ, Shapiro MZ, Dasaro CR, Todd AC, 

Prezant DJ, Boffetta P [2023]; A 15-Year Follow-Up 

Study of Mortality in a Pooled Cohort of World 

Trade Center Rescue and Recovery Workers, 

Environ Res 219:115116. 

21Singh A, Zeig-Owens R, Cannon M, Webber 

MP, Goldfarb DG, Daniels RD, Prezant DJ, Boffetta 

P, Hall CB [2023], All-Cause and Cause-Specific 

Mortality in a Cohort of WTC-Exposed and NonWTC-Exposed Firefighters, Occup Environ Med 

80(6):297–303. 

22Person-years means the cumulative sum of time 

that all study participants are under observation. 

23Colbeth HL, Zeig-Owens R, Hall CB, Webber 

MP, Schwartz TM, Prezant DJ [2020], Mortality 

among Fire Department of the City of New York 

Rescue and Recovery Workers Exposed to the World 

Trade Center Disaster, 2001–2017, Int J Environ Res 

Public Health 17(17):6266. Colbeth HL, Zeig-Owens 

R, Hall CB, Webber MP, et al. [2023]. Correction: 

Colbeth et al. Mortality among Fire Department of 

the City of New York rescue and recovery workers 

exposed to the World Trade Center disaster, 2001– 

2017, Int J Environ Res Public Health 2020, 17, 

6266, Int J Environ Res Public Health 20(16):6585. 

24 Jordan HT, Stein CR, Li J, Cone JE, Stayner L, 

Hadler JL, Brackbill RM, Farfel MR [2018], Mortality 

among Rescue and Recovery Workers and 

Community Members Exposed to the September 11, 

2001 World Trade Center Terrorist Attacks, 2003– 

2014, Environ Res 163:270–279. 

25Stein CR, Wallenstein S, Shapiro M, Hashim D, 

Moline JM, Udasin I, Crane MA, Luft BJ, Lucchini 

RG, Holden WL [2016], Mortality among World 

Trade Center Rescue and Recovery Workers, 2002– 

2011, Am J Ind Med 59(2):87–95. 

26 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, World Trade Center Disaster: Results from the 

World Trade Center Health Registry Cohort, Lancet 

378(9794):879–887. 

27 9/11 agents are chemical, physical, biological, 

or other hazards reported in a published, peerreviewed 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 Shanksville, Pennsylvania site, as those 

locations are defined in 42 CFR 88.1, as well as 

those hazards not identified in a published, peerreviewed exposure assessment study, but which are 

reasonably assumed to have been present at any of 

the three sites. See WTC Health Program [2018], 

Development of the Inventory of 9/11 Agents, July 

17, 2018, https://wwwn.cdc.gov/ResearchGateway/ 

Content/pdfs/Development_of_the_Inventory_of_9- 

11_Agents_20180717.pdf. 

28None of the studies provided to establish 

medical basis were found to meet the criteria for 

further evaluation, although they are discussed 

briefly in the Scientific Evaluation, infra note 28. 

29World Trade Center Health Program Science 

Team [2024], WTC Health Program Science Team 

Evaluation of Scientific Evidence Regarding the 

Addition of Amyotrophic Lateral Sclerosis to the 

List of WTC-Related Health Conditions, November 

20, 2024. 

30 It is generally thought that strong associations 

are more likely to be causal than weak associations; 

however, a weak association does not rule out a 

causal relationship. 

31Precision of the risk estimate describes the 

random error (‘‘chance’’) inherent in estimating the 

strength of association (the effect size) between 

exposure and the health condition. It is often 

expressed as a confidence interval illustrating a 

range of plausible values of the effect estimate given 

sampling error. A narrow confidence interval 

indicates a more precise measure of the effect and 

a wider interval indicates greater uncertainty. While 

precision is not a Bradford Hill criterion, the 

Science Team takes it into consideration to evaluate 

the extent of random error in study estimates. 

32Consistent findings are demonstrated when 

they have been repeatedly reported by multiple 

studies. When assessing consistency, the Science 

Team also considers differences in study quality 

that could explain inconsistent study findings. If 

only a single study is available for evaluation, the 

Science Team will place more emphasis on 

evaluating the strength of the association and 

precision of the risk estimate. 

33Specificity is the premise that an association is 

more likely to be causal if it is observed between 

one cause and one effect. In practice, epidemiologic 

examinations of health conditions in the 9/11- 

exposed population involve complex exposures to 

multiple 9/11 agents suspected of causing 

multifactorial diseases; therefore, specificity has a 

limited role in Science Team evaluations. 

Specificity has been given no weight in this 

evaluation due to the complexity of the proposed 

association between multiple 9/11 agents and ALS, 

a multifactorial disease. 

34Temporality is the condition that the 9/11 

exposure must precede the health condition of 

interest and is typically assessed when considering 

aspects of exposure in the study design. 

35Studies establish an exposure-response 

relationship by demonstrating that increases in 

exposure (i.e., exposures of greater intensity and/or 

longer duration) are associated with a greater 

incidence of disease. A thorough evaluation of 

exposure-response requires analysis of multiple 

levels of exposure such that the investigator can 

demonstrate that the risk increases with increasing 

levels of exposure. 

36Study findings demonstrate a basis in scientific 

theory that supports the relationship between the 

exposure and the health effect, and do not conflict 

with known facts about the biology of the health 

condition. 

37Coherence implies that the interpretation of a 

causal association agrees with known disease 

etiology. 

38Analogy is used to inform on biological 

plausibility and coherence by contrasting the 

Continued 

Workers, by Li et al. [2023],20 examined 

mortality among 60,631 Fire Department 

of New York (FDNY) responders, 

including firefighters and emergency 

medical service providers (n = 15,887), 

the WTC Health Program general 

responder cohort (GRC) (n = 25,657), 

and the WTC Health Registry (WTCHR) 

(n = 19,087). 

• All-Cause and Cause-Specific 

Mortality in a Cohort of WTC-Exposed 

and Non-WTC-Exposed Firefighters, by 

Singh et al. [2023],21 examined 

mortality patterns in male FDNY 

firefighters (n =10,786) followed 

through 2016 (163,583 person-years).22

• Mortality among Fire Department of 

the City of New York Rescue and 

Recovery Workers Exposed to the World 

Trade Center Disaster, 2001–2017, by 

Colbeth et al. [2020; 2023],23 examined 

mortality patterns in 15,431 FDNY 

responders followed through 2017 

(248,665 person-years). 

• Mortality among Rescue and 

Recovery Workers and Community 

Members Exposed to the September 11, 

2001 World Trade Center Terrorist 

Attacks, 2003–2014, by Jordan et al. 

[2018],24 examined WTCHR enrollees 

categorized as rescue/recovery workers 

(n = 29,280; 308,340 person-years) and 

lower Manhattan area community 

members (n = 39,643; 416,448 personyears). 

• Mortality among World Trade 

Center Rescue and Recovery Workers, 

2002–2011, by Stein et al. [2016],25

examined mortality in GRC responders 

(n = 30,947; 164,563 person-years). 

• Mortality among Survivors of the 

Sept 11, 2001, World Trade Center 

Disaster: Results from the World Trade 

Center Health Registry Cohort, by Jordan 

et al. [2011],26 conducted the first study 

of mortality among members of the 

WTCHR (2003–2009). Registry 

participants comprised responders (n = 

13,337; 74,967 person-years), and 

community members (n = 28,593; 

161,519 person-years); however, the 

study sample was restricted to 

participants residing in New York City 

at the time of Registry enrollment (n = 

41,930). 

Pursuant to the WTC Health 

Program’s Policy and Procedures, the 

Program conducted an evaluation of the 

six studies identified in the literature 

search to determine the likelihood of a 

causal association between 9/11 

exposures, including exposures to 9/11 

agents,27 and the petitioned health 

condition.28 The systematic literature 

search, the WTC Health Program 

Science Team’s evaluation and 

synthesis of the available literature, and 

the Science Team’s conclusions 

regarding the association between 9/11 

exposure and ALS are described in full 

in the WTC Health Program Science 

Team Evaluation of Scientific Evidence 

Regarding the Addition of Amyotrophic 

Lateral Sclerosis to the List of WTCRelated Health Conditions (Scientific 

Evaluation) found in the docket for this 

notice.29

The six studies identified as highquality and summarized in the 

Scientific Evaluation were evaluated 

individually and together to determine 

whether they provide a basis to support 

the addition of ALS to the List based on 

a causal relationship between 9/11 

exposures to WTC dust, injury, or 

experiences and ALS. As described in 

the Policy and Procedures, the WTC 

Health Program uses the following 

Bradford Hill criteria to evaluate studies 

of 9/11-exposed populations: strength of 

association 30 and precision of the risk 

estimate,31 consistency of association,32

specificity,33 temporality,34 biological 

gradient,35 and plausibility,36

coherence,37 and analogy.38 In addition 


lotter on DSK11XQN23PROD with NOTICES1
7702 Federal Register / Vol. 90, No. 13 / Wednesday, January 22, 2025 / Notices 

evidence on the suspected causal association with 

that from an established association between 

similar (analogous) causes or effects. 

39See Policy and Procedures supra note 5 at Sec. 

V.E.—Evidence is Inadequate to Determine a Causal 

Association. 

40See Policy and Procedures supra note 5 at Sec. 

VIII.B, proposed additions to the List are made 

pursuant to PHS Act, sec. 3312(a)(6)(B)(ii) and 42 

CFR 88.16(a)(2)(ii). The Administrator has also 

determined that insufficient evidence is available to 

publish a determination not to publish a proposed 

rule in the Federal Register (pursuant to PHS Act, 

sec. 3312(a)(6)(B)(iii) and 42 CFR 88.16(a)(2)(iii)); 

nor is requesting a recommendation from the STAC 

(pursuant to PHS Act, sec. 3312(a)(6)(B)(i) and 42 

CFR 88.16(a)(2)(i)) warranted. 

to the Bradford Hill criteria, the Science 

Team also considered the limitations of 

the evaluated evidence and whether the 

evidence represents the 9/11-exposed 

population. 

The Science Team discussed its 

evaluation in full in the Scientific 

Evaluation, and summarized its findings 

in table 5, which is reproduced here: 

Aspect of associative causal inference (‘‘Bradford Hill Criteria’’) [Hill 

1965] 

Evaluation findings 

Strength of association (and estimate precision).Among six high-quality studies identified for evaluation, none examined ALS risk separately in 9/11-exposed populations [Colbeth et al. 2020, 2023; Jordan et al. 2011; Jordan et al. 2018; Li et al. 2023; 

Singh et al. 2023; Stein et al. 2016]. Among the six studies, only one reported a statistically significant 

positive association of indicating modest excess of mortality from nervous system disorders, including 

ALS, among WTC Health Registry community members [Jordan et al. 2018]. The authors attributed the 

observed excess to Alzheimer’s disease, not ALS. The finding strongly depended on the choice of control group, indicating a potential for strong selection bias. The use of composite outcomes, external reference groups, and lack of exposure information are important study limitations common to all studies 

evaluated. 

Consistency ..................................... All but the study by Jordan et al. [2018] reported less than expected deaths from nervous disorders when 

using an external reference population. Results supporting a causal association between 9/11 exposure 

and composite outcomes of neurologic diseases including ALS were not reproduced in different 9/11-exposed populations (e.g., firefighters, general responders, and community members). The lack of reproducible results is a strong limitation of causal inference. 

Temporality ..................................... 9/11 exposure was presumed to precede ALS onset because all studies were longitudinal and began observation on or after 9/11. However, no studies specifically examined temporal variations in risk. 

Biological gradient ........................... One study examined the exposure-response between categories of 9/11 exposure and mortality from a 

composite of other nervous system disorders (including ALS) in community members [Jordan et al. 

2018]. That study found no evidence of increasing risk with 9/11 exposure. 

Plausibility, Coherence, and Analogy.There are no established environmental factors that are causal for ALS; therefore, no 9/11 agent has been 

identified as a contributing cause. However, the literature supports a general conclusion that a causal 

association between a 9/11 agent (e.g., metals, silica, formaldehyde) and ALS is plausible, although 

unproven. 

The assumption that the risk observed in a composite outcome is analogous to ALS risk is unsubstantiated, which is an important study limitation. 

Representativeness ........................ There was representation of all groups of 9/11-exposed populations. 

Upon review of the evidence available 

in peer-reviewed, published, 

epidemiological studies regarding ALS 

among 9/11-exposed populations, the 

Science Team has assessed the degree to 

which the evidence supports a causal 

association between 9/11 exposures and 

ALS and has determined that the 

available evidence is inadequate to 

determine the likelihood of a causal 

association 39 between 9/11 exposures 

and ALS (Category 5). The Science 

Team’s evaluation and categorization of 

the evidence has been provided to the 

Administrator. 

E. Administrator’s Final Decision on 

Whether To Propose the Addition of 

Amyotrophic Lateral Sclerosis to the 

List 

Based on the Scientific Evaluation 

and the Science Team’s finding that 

there is inadequate evidence to 

determine whether a causal association 

exists between 9/11 exposures and ALS, 

the Administrator has determined that 

there is insufficient evidence of causal 

association between 9/11 exposures and 

ALS to propose adding the condition to 

the List.40 Pursuant to PHS Act, sec. 

3312(a)(6)(B)(iv) and 42 CFR 

88.16(a)(2)(iv), and in accordance with 

Sec. IX.B. of the Policy and Procedures, 

the Administrator is publishing this 

notice of his determination of 

insufficient evidence. 

For the reasons discussed above, the 

request of Petitions 031, 036, 039, and 

053 to add ALS to the List of WTCRelated Health Conditions is denied. 

F. Approval To Submit Document to the 

Office of the Federal Register 

The Secretary, HHS, or his designee, 

the Director, Centers for Disease Control 

and Prevention (CDC) and 

Administrator, Agency for Toxic 

Substances and Disease Registry 

(ATSDR), authorized the undersigned, 

the Administrator of the WTC Health 

Program, to sign and submit the 

document to the Office of the Federal 

Register for publication as an official 

document of the WTC Health Program. 

Mandy Cohen M.D., M.P.H., Director, 

CDC, and Administrator, ATSDR, 

approved this document for publication 

on January 6, 2025. 

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. 

[FR Doc. 2025–00692 Filed 1–17–25; 11:15 am] 

BILLING CODE 4163–18–P 

INTERNATIONAL TRADE 

COMMISSION 

[Investigation Nos. 701–TA–754 and 731– 

TA–1732 (Preliminary)] 

Temporary Steel Fencing From China; 

Institution of Antidumping and 

Countervailing Duty Investigations and 

Scheduling of Preliminary Phase 

Investigations 

AGENCY: United States International 

Trade Commission. 

ACTION: Notice. 


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