World Trade Center Health Program; Petitions 031, 036, 039, and 053-Amyotrophic Lateral Sclerosis; Finding of Insufficient Evidence

<NOTICE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Centers for Disease Control and Prevention</SUBAGY> <DEPDOC>[NIOSH Docket 094]</DEPDOC> <SUBJECT>World Trade Center Health Program; Petitions 031, 036, 039, and 053—Amyotrophic Lateral Sclerosis; Finding of Insufficient Evidence</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Centers for Disease Control and Prevention, Health and Human Services (HHS). <HD SOURCE="HED">ACTION:</HD> Denial of petitions for addition of a health condition. <SUM> <HD SOURCE="HED">SUMMARY:</HD> 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. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> The Administrator of the WTC Health Program is denying these petitions for the addition of a health condition as of January 22, 2025. </DATES> <HD SOURCE="HED">ADDRESSES:</HD> Visit the WTC Health Program website at <E T="03">https://www.cdc.gov/wtc/received.html</E> to review Petitions 031, 036, 039, and 053. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> 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 <E T="03">NIOSHregs@cdc.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">Table of Contents</HD> <EXTRACT> <FP SOURCE="FP-2">A. WTC Health Program Statutory Authority</FP> <FP SOURCE="FP-2">B. Procedures for Evaluating a Petition</FP> <FP SOURCE="FP-2">C. Petitions 031, 036, 039, and 053</FP> <FP SOURCE="FP-2">D. Review of Scientific Evaluation</FP> <FP SOURCE="FP-2">E. Administrator's Final Decision on Whether To Propose the Addition of Amyotrophic Lateral Sclerosis to the List</FP> <FP SOURCE="FP-2">F. Approval to Submit Document to the Office of the Federal Register</FP> </EXTRACT> <HD SOURCE="HD1">A. WTC Health Program Statutory Authority</HD> 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, <SU>1</SU> <FTREF/> thereby establishing the WTC Health Program within HHS. The WTC Health Program provides medical monitoring and treatment benefits for health conditions on the List  <SU>2</SU> <FTREF/> 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). 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  <SU>3</SU> <FTREF/> (survivors). <FTNT> <SU>1</SU>  Title 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. </FTNT> <FTNT> <SU>2</SU>  The 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. </FTNT> <FTNT> <SU>3</SU>   <E T="03">See</E> 42 U.S.C. 300mm-5(7); 42 CFR 88.1. </FTNT> 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 <E T="04">Federal Register</E> to add such health condition; (3) publish in the <E T="04">Federal Register</E> the Administrator's determination not to publish such a proposed rule and the basis for such determination; or (4) publish in the <E T="04">Federal Register</E> 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 <E T="03">www.cdc.gov/wtc/.</E> <HD SOURCE="HD1">B. Procedures for Evaluating a Petition</HD> In addition to the regulatory provisions, the WTC Health Program has developed policies to guide the review of submissions and petitions, <SU>4</SU> <FTREF/> as well as the evaluation of evidence supporting the potential addition of a non-cancer health condition to the List. <SU>5</SU> <FTREF/> <FTNT> <SU>4</SU>   <E T="03">See</E> WTC Health Program [2014], <E T="03">Policy and Procedures for Handling Submissions and Petitions to Add a Health Condition to the List of WTC-Related Health Conditions,</E> May 14, 2014, <E T="03">http://www.cdc.gov/wtc/pdfs/WTCHPPPPetitionHandlingProcedures14May2014.pdf.</E> </FTNT> <FTNT> <SU>5</SU>   <E T="03">See</E> WTC Health Program [2024], <E T="03">Policy and Procedures for Adding Non-Cancer Conditions to the List of WTC-Related Health Conditions,</E> October 18, 2024, <E T="03">https://www.cdc.gov/wtc/pdfs/policies/WTCHP_PP_Adding_NonCancer_Health_Conditions_20241018.pdf.</E> </FTNT> 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 <E T="03">Policy and Procedures for Handling Submissions and Petitions to Add a Health Condition to the List of WTC-Related Health Conditions,</E> reference to a peer-reviewed, 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 previously-evaluated 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 <E T="03">Policy and Procedures for Adding Non-Cancer Conditions to the List of WTC-Related Health Conditions</E> ( <E T="03">Policy and Procedures</E> ), 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. <SU>6</SU> <FTREF/> The literature review is a keyword search of relevant scientific databases intended to identify peer-reviewed, published, epidemiologic studies about the health condition among 9/11-exposed populations. <FTNT> <SU>6</SU>   <E T="03">Id.</E> at 6. </FTNT> Using validity indicators detailed in the <E T="03">Policy and Procedures,</E> 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, <SU>7</SU> <FTREF/> 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: <FTNT> <SU>7</SU>  Hill AB [1965], <E T="03">The Environment and Disease: Association or Causation?</E> Proc R Soc Med 58(5):295-300. According to the <E T="03">Policy and Procedures for Adding Non-Cancer Conditions to the List of WTC-Related Health</E> 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.” <E T="03">See supra</E> note 5 at 9, footnote 21. </FTNT> (1) substantial likelihood of causal association, (2) high likelihood of causal association, ( ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 38k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━