Uterine Cancer, Including Endometrial Cancer, to Health Condition to the List in 42 CFR Administrator of the World Trade 88.15
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49954 Federal Register / Vol. 84, No. 185 / Tuesday, September 24, 2019 / Rules and Regulations PART 300—NATIONAL OIL AND Authority: 33 U.S.C. 1321(d); 42 U.S.C. ■ 2. Table 1 of appendix B to part 300 HAZARDOUS SUBSTANCES 9601–9657; E.O. 13626, 77 FR 56749, 3 CFR, is amended by revising the entry for POLLUTION CONTINGENCY PLAN 2013 Comp., p. 306; E.O. 12777, 56 FR 54757, ‘‘FL’’, ‘‘Escambia Wood—Pensacola’’, 3 CFR, 1991 Comp., p. 351; E.O. 12580, 52 ‘‘Pensacola’’ to read as follows: FR 2923, 3 CFR, 1987 Comp., p. 193. ■ 1. The authority citation for part 300 Appendix B to Part 300—National continues to read as follows: Priorities List TABLE 1—GENERAL SUPERFUND SECTION State Site name City/county Notes a ******* FL .............................................................. Escambia Wood—Pensacola ................... Pensacola ................................................. P. ******* a = Based on issuance of health advisory by Agency for Toxic Substances and Disease Registry (if scored, HRS score need not be greater than or equal to 28.50). ******* P = Sites with partial deletion(s). * * * * * for the addition of a health condition as enforcement officers, and rescue, [FR Doc. 2019–20347 Filed 9–23–19; 8:45 am] of September 24, 2019. recovery, and cleanup workers who BILLING CODE 6560–50–P ADDRESSES: Visit the WTC Health responded to the September 11, 2001, Program website at https:// terrorist attacks in New York City, at the www.cdc.gov/wtc/received.html to Pentagon, and in Shanksville, review Petition 023. Pennsylvania (responders), and to DEPARTMENT OF HEALTH AND eligible persons who were present in the HUMAN SERVICES FOR FURTHER INFORMATION CONTACT: Rachel Weiss, Program Analyst, 1090 dust or dust cloud on September 11, 42 CFR Part 88 Tusculum Avenue, MS: C–48, 2001, or who worked, resided, or Cincinnati, OH 45226; telephone (855) attended school, childcare, or adult [NIOSH Docket 094] 818–1629 (this is a toll-free number); daycare in the New York City disaster email [email protected]. area (survivors). World Trade Center Health Program; SUPPLEMENTARY INFORMATION: All references to the Administrator of Petition 023—Uterine Cancer, Table of Contents the WTC Health Program Including Endometrial Cancer; Finding (Administrator) in this document mean of Insufficient Evidence A. WTC Health Program Statutory Authority the Director of the National Institute for B. Procedures for Evaluating a Petition for AGENCY: Centers for Disease Control and Cancer Occupational Safety and Health Prevention, HHS. C. Petition 023 (NIOSH) or his designee. ACTION: Denial of petition for addition of D. Assessment of Scientific and Medical Pursuant to section 3312(a)(6)(B) of a health condition. Information the PHS Act, interested parties may E. Administrator’s Final Decision on Whether petition the Administrator to add a SUMMARY: On April 23, 2019, the To Propose the Addition of Uterine Cancer, Including Endometrial Cancer, to health condition to the List in 42 CFR Administrator of the World Trade 88.15. Within 90 days after receipt of a Center (WTC) Health Program received the List F. Approval To Submit Document to the valid petition to add a condition to the a petition (Petition 023) to add Office of the Federal Register List, the Administrator must take one of ‘‘endometrial cancer’’ to the List of the following four actions described in WTC-Related Health Conditions (List). A. WTC Health Program Statutory section 3312(a)(6)(B) of the PHS Act and Upon reviewing the scientific and Authority § 88.16(a)(2) of the Program regulations: medical literature, including Title I of the James Zadroga 9/11 (1) Request a recommendation of the information provided by the petitioner, Health and Compensation Act of 2010 STAC, (2) publish a proposed rule in the the Administrator has determined that (Pub. L. 111–347, as amended by Pub. the available evidence does not have the Federal Register to add such health L. 114–113), added Title XXXIII to the condition, (3) publish in the Federal potential to provide a basis for a Public Health Service (PHS) Act,1 decision on whether to add the major Register the Administrator’s establishing the WTC Health Program determination not to publish such a site uterine cancer, including its within the Department of Health and proposed rule and the basis for such subtype, endometrial cancer, to the List. Human Services (HHS). The WTC determination, or (4) publish in the The Administrator also finds that Health Program provides medical Federal Register a determination that insufficient evidence exists to request a monitoring and treatment benefits for recommendation of the WTC Health health conditions on the List to eligible insufficient evidence exists to take Program Scientific/Technical Advisory firefighters and related personnel, law action under (1) through (3) above. Committee (STAC), to publish a B. Procedures for Evaluating a Petition proposed rule, or to publish a 1 Title XXXIII of the PHS Act is codified at 42 for Cancer determination not to publish a proposed U.S.C. 300mm to 300mm-61. Those portions of the rule. James Zadroga 9/11 Health and Compensation Act In addition to the regulatory of 2010 found in Titles II and III of Public Law 111– DATES: The Administrator of the WTC 347 do not pertain to the WTC Health Program and provisions, the WTC Health Program Health Program is denying this petition are codified elsewhere. has developed policies to guide the VerDate Sep<11>2014 15:47 Sep 23, 2019 Jkt 247001 PO 00000 Frm 00014 Fmt 4700 Sfmt 4700 E:\FR\FM\24SER1.SGM 24SER1 khammond on DSKJM1Z7X2PROD with RULES Federal Register / Vol. 84, No. 185 / Tuesday, September 24, 2019 / Rules and Regulations 49955 review of submissions and petitions,2 as deciding whether to propose adding the A type of cancer may be added to the List well as the analysis of evidence type of cancer to the List. if the STAC has provided a reasonable basis supporting the potential addition of a If the Program determines that the for adding a type of cancer. type of cancer to the List.3 relevant studies have the potential to If the evaluation of evidence required A valid petition must include provide a basis for deciding whether to for any of the four methods sufficient medical basis for the propose adding the type of cancer to the demonstrates that the criteria in that association between the September 11, List, the cancer type may be added to method are satisfied, the Administrator 2001, terrorist attacks and the health the List if one of the four following will propose the addition of the type of condition to be added; in accordance methods is met: cancer to the List. with WTC Health Program policy, Method 1. Epidemiologic Studies of C. Petition 023 reference to a peer-reviewed, published, September 11, 2001-Exposed Populations. epidemiologic study about the health The peer-reviewed, published, On April 23, 2019, the Administrator condition among 9/11-exposed epidemiologic studies of 9/11-exposed received a petition (Petition 023) populations or to clinical case reports of populations are assessed by applying the requesting the addition of ‘‘endometrial following criteria extrapolated from the health conditions in WTC responders or cancer’’ to the List.9 The petition Bradford Hill criteria, as appropriate: 10 survivors may demonstrate the required a. Strength of the association between a 9/ included a 2002 study by Lioy et al. 11 medical basis.4 Studies linking 9/11 11 exposure and a type of cancer (including and a 2017 study by McElroy et al. agents 5 or hazards to the petitioned the precision of the risk estimate 6), which together provided sufficient health condition may also provide b. Consistency of the findings across medical basis for the petition to be sufficient medical basis for a valid multiple studies. If only a single published considered valid because they petition. epidemiologic study is available for demonstrate the presence of 9/11 agents, assessment, the consistency of findings including cadmium, at the WTC site and After the Program has determined that cannot be evaluated and more emphasis will a petition is valid, the Administrator be placed on evaluating the strength of the that cadmium exposure is associated must direct the Program to conduct a association and the precision of the risk with a statistically significant increase systematic literature search (a keyword estimate, in endometrial cancer risk. However, search of relevant scientific databases) c. Biological gradient, or dose-response because neither Lioy et al. [2002] nor to gather information about the relationships between 9/11 exposures and McElroy et al. [2017] is a peer-reviewed, the type of cancer, and published, epidemiologic study of following: (1) Studies about the type of d. Plausibility and coherence with known cancer requested to be added to the List endometrial cancer (or the major site, facts about the biology of the type of cancer. uterine cancer) in a 9/11-exposed among 9/11-exposed populations, (2) Method 2. Established Causal Associations. studies showing a potential causal A type of cancer may be added to the List population, neither study is considered association between the requested if there is well-established scientific support relevant nor are they further reviewed in cancer and a health condition on the published in multiple epidemiologic studies this action. List, and (3) classifications of the World for a causal association between that cancer In the Program’s List of WTC-Related Health Organization’s International and a condition already on the List of WTC- Health Conditions, types of cancer are Related Health Conditions. Agency for Research on Cancer (IARC) identified by the major cancer site/ Method 3. Review of Evaluations of histology groups that are commonly and the National Toxicology Program Carcinogenicity in Humans.