World Trade Center Health Program; Addition of Certain Types of Cancer to the List of WTC-Related Health Conditions, 35574-35615 [2012-14203]

Download as PDF 35574 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules SUPPLEMENTARY INFORMATION [Docket No. CDC–2012–0007; NIOSH–257] 42 CFR Part 88 RIN 0920–AA49 World Trade Center Health Program; Addition of Certain Types of Cancer to the List of WTC-Related Health Conditions Centers for Disease Control and Prevention, HHS. ACTION: Notice of proposed rulemaking. AGENCY: 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, which is administered by the Director of the National Institute for Occupational Safety and Health (NIOSH), within the Centers for Disease Control and Prevention (CDC), provides medical monitoring and treatment 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, and to eligible survivors of the New York City attacks. In accordance with our regulations, which establish procedures for adding a new condition to the list of health conditions covered by the WTC Health Program, this proposed rule would add certain types of cancer to the List of WTCRelated Health Conditions. DATES: Comments must be received by July 13, 2012. ADDRESSES: Written Comments: You may submit comments by any 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–C34, 4676 Columbia Parkway, Cincinnati, OH 45226. • Facsimile: (513) 533–8285. Instructions: All submissions received must include the agency name (Centers for Disease Control and Prevention, HHS) and docket number (CDC–2012– 007; NIOSH–257) or Regulation Identifier Number (0920–AA49) for this rulemaking. All relevant comments, including any personal information provided, will be posted without change to https://www.regulations.gov. For detailed instructions on submitting public comments, see the ‘‘Public erowe on DSK2VPTVN1PROD with PROPOSALS2 SUMMARY: VerDate Mar<15>2010 15:06 Jun 12, 2012 Jkt 226001 VI. Proposed Rule Participation’’ heading of the DEPARTMENT OF HEALTH AND HUMAN SERVICES section of this document. Docket: For access to the docket to read background documents, go to https://www.regulations.gov or https:// www.cdc.gov/niosh/docket/archive/ docket257.html. FOR FURTHER INFORMATION CONTACT: Frank J. Hearl, PE, Chief of Staff, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention, Patriots Plaza, Suite 9200, 395 E St. SW., Washington, DC 20201. Telephone: (202) 245–0625 (this is not a toll-free number). Email: WTCpublicinput@cdc.gov. SUPPLEMENTARY INFORMATION: This notice of proposed rulemaking is organized as follows: 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. Addition of Health Conditions to the List of WTC-Related Health Conditions C. Need for Rulemaking D. Addition of Certain Types of Cancer to the List of WTC-Related Health Conditions 1. Scientific/Technical Advisory Committee (STAC) Recommendations 2. Administrator’s Review of Available Scientific Information and the STAC’s Recommendations 3. Methods Used by the Administrator to Determine Whether to Add Cancer or Types of Cancer to the List of WTCRelated Health Conditions 4. Administrator’s Determination Concerning Petition 001 5. Explanations for Adding Certain Types of Cancer to the List of WTC-Related Health Conditions 6. Certification and Treatment of WTCRelated Health Conditions Including Types of Cancer 7. Endnotes E. Effects of Rulemaking on Federal Agencies IV. Summary of Proposed Rule V. Regulatory Assessment Requirements A. Executive Order 12866 and Executive Order 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 PO 00000 Frm 00002 Fmt 4701 Sfmt 4702 I. Executive Summary A. Purpose of Regulatory Action Title I of the James Zadroga 9/11 Health and Compensation Act of 2010 (Pub. L. 111–347), amended the Public Health Service Act (PHS Act) establishing the World Trade Center (WTC) Health Program within the Department of Health and Human Services (HHS). The PHS Act requires the WTC Program Administrator (Administrator) to conduct rulemaking to propose the addition of a health condition to the List of WTC-Related Health Conditions (List) codified in 42 CFR 88.1 whether the Administrator adds a health condition based on the findings from periodic reviews of cancer,1 based on a request from a petition, or based on a determination made at the Administrator’s discretion that a proposed rule adding a condition should be initiated. Following a petition to add cancer or certain types of cancer to the List and a recommendation by the WTC Health Program’s Scientific/ Technical Advisory Committee (STAC), the Administrator is following the procedures established in 42 CFR 88.17 to add some, but not all types of cancer recommended by the petition. B. Summary of Major Provisions This rule modifies the List of WTCRelated Health Conditions in 42 CFR 88.1 to add the following conditions (types of cancer identified by ICD–10 code are specified in the discussion below): D Malignant neoplasms of the lip, tongue, salivary gland, floor of mouth, gum and other mouth, tonsil, oropharynx, hypopharynx, and other oral cavity and pharynx D Malignant neoplasm of the nasopharynx D Malignant neoplasms of the nose, nasal cavity, middle ear, and accessory sinuses D Malignant neoplasm of the larynx D Malignant neoplasm of the esophagus D Malignant neoplasm of the stomach D Malignant neoplasm of the colon and rectum D Malignant neoplasm of the liver and intrahepatic bile duct D Malignant neoplasms of the retroperitoneum and peritoneum, omentum, and mesentery D Malignant neoplasms of the trachea; bronchus and lung; heart, mediastinum and pleura; and other ill-defined sites in the respiratory system and intrathoracic organs 1 See E:\FR\FM\13JNP2.SGM PHS Act, Title XXXIII § 3312(a)(5). 13JNP2 35575 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules D Mesothelioma D Malignant neoplasms of the soft tissues (sarcomas) D Malignant neoplasms of the skin (melanoma and non-melanoma), including scrotal cancer D Malignant neoplasm of the breast D Malignant neoplasm of the ovary D Malignant neoplasm of the urinary bladder D Malignant neoplasm of the kidney D Malignant neoplasms of renal pelvis, ureter and other urinary organs D Malignant neoplasms of the eye and orbit D Malignant neoplasm of the thyroid D Malignant neoplasms of the blood and lymphoid tissues (including, but not limited to, lymphoma, leukemia, and myeloma) D Childhood cancers D Rare cancers The Administrator developed a hierarchy of methods (detailed in section III.D of this preamble) for determining which cancers to propose for inclusion on the List of WTC-Related Health Conditions. HHS is seeking comments on the proposed methods in this rule. C. Costs and Benefits Annual costs, benefits, and transfers of this rule are listed in the table below. This analysis estimates the impact on WTC Health Program costs using the number of persons currently enrolled in the program as responders and survivors and assumes that the rate of cancer in the population will be equal to the U.S. population average rate. An alternative analysis considers the impact on costs if the Program enrolls additional persons up to the Program’s statutory limits, and that the expanded population experiences a 21 percent higher rate of cancer than the U.S. population average. The basis for these assumptions is explained in detail in the preamble of this rulemaking. Although we cannot quantify the benefits associated with the WTC Health Program, enrollees with cancer are expected to experience a higher quality of care than they would in the absence of the Program. Mortality and morbidity improvements for cancer patients expected to enroll in the WTC Health Program are anticipated because barriers may exist to access and delivery of quality health care services for cancer patients in the absence of the services provided by the WTC Health Program. HHS anticipates benefits to cancer patients treated through the WTC Health Program, who may otherwise not have access to health care services, to accrue in 2013. Starting in 2014, continued implementation of the Affordable Care Act will result in increased access to health insurance and improved health care services for the general responder and survivor population that currently is uninsured. ESTIMATED ANNUAL WTC HEALTH PROGRAM COSTS, BENEFITS, AND TRANSFERS, 55,000 RESPONDERS AND 5,000 SURVIVORS AT U.S. POPULATION CANCER RATE, AND 80,000 RESPONDERS AND 30,000 SURVIVORS AT U.S. POPULATION CANCER RATE + 21 PERCENT, 2013–2016, 2011$ Societal Costs for 2013, 2011$ Based on the 16.3 percent of general responders and survivors who are expected to be uninsured Annualized Transfers for 2013–2016, 2011$ Discounted at 7 percent Cancer Rate U.S. Average Discounted at 3 percent Cancer Rate U.S. + 21% U.S. Average U.S. + 21% 55,000 Responders ................................................................. 5,000 Survivors ........................................................................ Colorectal and Breast Screening ............................................. $1,648,706 271,427 204,491 .............................. .............................. .............................. $10,172,308 1,572,907 713,321 .............................. .............................. .............................. 60,000 Total ...................................................................... 2,124,624 .............................. 12,458,535 .............................. 80,000 Responders ................................................................. 30,000 Survivors ...................................................................... Colorectal and Breast Screening ............................................. .............................. .............................. .............................. $2,631,100 1,970,560 417,521 .............................. .............................. .............................. $19,912,464 12,124,118 1,271,478 110,000 Total .................................................................... .............................. 5,019,182 .............................. 33,308,060 Qualitative benefits: Although we cannot quantify the benefits associated with the WTC Health Program, enrollees with cancer are expected to experience a higher quality of care than they would in the absence of the Program. Mortality and morbidity improvements for cancer patients expected to enroll in the WTC Health Program are anticipated because barriers may exist to access and delivery of quality health care services for cancer patients in the absence of the services provided by the WTC Health Program. HHS anticipates benefits to cancer patients treated through the WTC Health Program, who may otherwise not have access to health care services, to accrue in 2013. Starting in 2014, continued implementation of the Affordable Care Act will result in increased access to health insurance and improved health care services for the general responder and survivor population that currently is uninsured. erowe on DSK2VPTVN1PROD with PROPOSALS2 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. Do not VerDate Mar<15>2010 15:06 Jun 12, 2012 Jkt 226001 include any information in your comment or supporting materials that you consider confidential or inappropriate for public disclosure. Comments are invited on any topic related to this proposed rule. The Administrator is seeking comments from the public on the following specific topics: PO 00000 Frm 00003 Fmt 4701 Sfmt 4702 1. The four methods proposed to evaluate evidence for the addition of types of cancer to the List of WTCRelated Health Conditions; 2. Information or published studies about the type of welding that occurred in the New York City disaster area, at the Pentagon, or at Shanksville, Pennsylvania with regard to metal E:\FR\FM\13JNP2.SGM 13JNP2 35576 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules cutting not involving exposure to ultraviolet light and welding involving ultraviolet light exposure; and 3. Information or published studies about work hours scheduling or shiftwork occurring in the New York City disaster area, at the Pentagon, or in Shanksville, Pennsylvania. Comments submitted electronically or by mail should be titled ‘‘Docket No. CDC–2012–0007; NIOSH–257,’’ addressed to the ‘‘NIOSH Docket Officer,’’ and should identify the author(s) and contact information (such as return address, email address, or phone number), in case clarification is needed. Electronic and written comments can be submitted to the addresses provided in the ADDRESSES section, above. All communications received on or before the closing date for comments will be fully considered by the Administrator of the WTC Health Program. III. Background A. WTC Health Program Statutory Authority Title I of the James Zadroga 9/11 Health and Compensation Act of 2010 (Pub. L. 111–347), amended the Public Health Service Act (PHS Act) to add Title XXXIII 2 establishing the World Trade Center (WTC) Health Program within the Department of Health and Human Services (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, and to eligible survivors of the New York City attacks. All references to the Administrator of the WTC Health Program (Administrator) in this notice mean the NIOSH Director or his or her designee. Title XXXIII, § 3312(a)(6) of the PHS Act requires the Administrator to conduct rulemaking to propose the addition of a health condition to the List of WTCRelated Health Conditions (List) codified in 42 CFR 88.1. erowe on DSK2VPTVN1PROD with PROPOSALS2 B. Addition of Health Conditions to the List of WTC-Related Health Conditions Under 42 CFR 88.17, the Administrator has established a process 2 Title XXXIII of the Public Health Service 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 World Trade Center Health Program and are codified elsewhere. VerDate Mar<15>2010 15:06 Jun 12, 2012 Jkt 226001 by which health conditions may be considered for addition to the List of WTC-Related Health Conditions in § 88.1. Pursuant to § 3312(a)(6) of Title XXXIII of the PHS Act, the Administrator is required to publish a notice of proposed rulemaking and allow interested parties to comment on the proposed rule. The proposed rule may be initiated by the Administrator whenever he or she determines that a proposed rule should be promulgated to add a health condition (e.g., when a review of WTC Health Program monitoring data reveals the prevalence of a condition not previously identified in Title XXXIII or by the Program), on the basis of the WTC Health Program’s periodic review of all available scientific and medical evidence of cancer or a certain type of cancer pursuant to § 3312(a)(5) of Title XXXIII, or in response to a petition submitted by an interested party. Upon receipt of a petition from an interested party to add a condition to the List of WTC-Related Health Conditions, the Administrator is authorized to request a recommendation of the WTC Health Program STAC; or publish a proposed rule to add such health condition; or publish the Administrator’s determination not to publish a proposed rule and the basis for that determination; or to publish a determination that insufficient evidence exists to take action. C. Need for Rulemaking On September 7, 2011, the Administrator of the WTC Health Program received a written petition to add a health condition to the List of WTC-Related Health Conditions (Petition 001). Petition 001 requested that the Administrator ‘‘consider adding coverage for cancer under the Zadroga Act’’ to the List in § 88.1. [Maloney, et al. 2011] On October 5, 2011, the Administrator formally exercised his option to request a recommendation from the STAC regarding the petition (PHS Act, Title XXXIII, § 3312(a)(6)(B)(i); 42 CFR 88.17(a)(2)(i)). The Administrator requested that the STAC ‘‘review the available information on cancer outcomes associated with the exposures resulting from the September 11, 2001, terrorist attacks, and provide advice on whether to add cancer, or a certain type of cancer, to the List specified in the Zadroga Act.’’ [Howard 2011] The background to this rulemaking and a discussion of the STAC’s recommendation are provided below. PO 00000 Frm 00004 Fmt 4701 Sfmt 4702 D. Addition of Certain Types of Cancer to the List of WTC-Related Health Conditions To determine whether the scientific evidence is sufficient to support the addition of cancer or types of cancer to the List of WTC-Related Health Conditions, the Administrator considered data from five information sources: (1) Peer-reviewed studies published in the scientific literature, including environmental sampling data, epidemiologic studies on the 9/11 exposed populations, and studies providing evidence of a causal relationship between a type of cancer and a condition already on the List of WTC-Related Health Conditions; (2) findings and recommendations solicited from the WTC Clinical Centers of Excellence and Data Centers, the WTC Health Registry at the New York City Department of Health and Mental Hygiene, and the New York State Department of Health; (3) information from the public solicited through a request for information published in the Federal Register on March 8, 2011 and March 29, 2011; (4) the findings of the National Toxicology Program (NTP) in the National Institute of Environmental Health Sciences, HHS, as well as the World Health Organization’s International Agency for Research on Cancer (IARC); and (5) findings from other sources of information relevant to 9/11 exposures, including the expert judgment and personal experiences of STAC members, and comments from the public. NTP, an interagency program that evaluates agents of public health concern using toxicology and molecular biology, publishes the biennial Report on Carcinogens (RoC), which contains a list of human carcinogens, exposure information, and descriptions of Federal exposure limits.3 The RoC classifies agents in one of two ways: known to be a human carcinogen, and reasonably anticipated to be a human carcinogen; this classification is determined by an expert panel convened for each candidate substance and is based on an evaluation of the published, peerreviewed literature and reviews conducted by Federal agencies and IARC. Unlike IARC, NTP does not identify specific types of cancer that have sufficient evidence of carcinogenicity. IARC, which coordinates and conducts research on the causes of human cancer and the mechanisms of carcinogenesis, maintains a series of 3 NTP Report on Carcinogens (RoC). https:// ntp.niehs.nih.gov/?objectid=72016262-BDB7-CEBAFA60E922B18C2540. Accessed May 9, 2012. E:\FR\FM\13JNP2.SGM 13JNP2 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules erowe on DSK2VPTVN1PROD with PROPOSALS2 Monographs on the carcinogenic risks to humans caused by chemicals, complex mixtures, occupational exposures, physical agents, biological agents, and lifestyle factors. In the Monographs, carcinogens are categorized according to whether they provide sufficient evidence of carcinogenicity in humans for a certain type of cancer (Group 1); or limited evidence of carcinogenicity in humans, including agents probably carcinogenic to humans (Group 2A) and agents possibly carcinogenic to humans (Group 2B); whether they are not classifiable as to carcinogenicity in humans (Group 3); or whether there is evidence suggesting lack of carcinogenicity (Group 4).4 IARC convenes working groups of international experts to develop each Monograph based on reviews of epidemiological, animal, and mechanistic data ‘‘that have been published or accepted for publication in the openly available scientific literature,’’ although ‘‘[i]n certain instances, government agency reports that have undergone peer review and are widely available are considered.’’ [IARC 2006] In July 2011, the Administrator released the First Periodic Review of the Scientific and Medical Evidence Related to Cancer for the World Trade Center Health Program (First Periodic Review). [NIOSH 2011] As required by Title XXXIII, § 3312(a)(5)(A) of the PHS Act, the Administrator reviewed ‘‘all available scientific and medical evidence, including findings and recommendations of Clinical Centers of Excellence, published in peer-reviewed journals to determine if, based on such evidence, cancer or a certain type of cancer should be added to the applicable list of WTC-related health conditions.’’ As described in the First Periodic Review, environmental sampling identified 287 chemicals and chemical groups as present in the New York City disaster area (referred to herein as ‘‘9/11 agents’’ 5). [COPC 2003] Published exposure assessments reviewed by the Administrator in the First Periodic Review ‘‘suggest that responders and others in the nearby area were potentially exposed to one or more of the substances designated by IARC and NTP as known or reasonably anticipated human carcinogens, 4 WHO International Agency for Research on Cancer (IARC). https://monographs.iarc.fr/. Accessed May 8, 2012. 5 Several other agents were recommended by the STAC, verified in the published literature, and are also considered 9/11 agents. The agents identified at the Pentagon and in Shanksville, Pennsylvania were reviewed but no additional agents were identified. VerDate Mar<15>2010 15:06 Jun 12, 2012 Jkt 226001 although generally not in excess of applicable occupational exposure limits.’’ [NIOSH 2011] At the time of publication, the First Periodic Review [NIOSH 2011] identified only one peer-reviewed article addressing the association of exposures arising from the September 11, 2001, terrorist attacks and cancer in responders and survivors, and two publications that used models to estimate the risk of cancer among residents in Lower Manhattan. The Administrator used a ‘‘weight of the evidence’’ approach to evaluate data derived from information sources (1)– (3), discussed above, and reported that insufficient evidence existed at that time to propose the addition of cancer or certain types of cancer to the List of WTC-Related Health Conditions. In September 2011, an epidemiologic study was published in The Lancet. The study, by Rachel Zeig-Owens and colleagues, ‘‘identified a modest effect of WTC exposure for all cancers combined by comparing the ratios in the exposed group [of Fire Department of New York City firefighters] to those in the non-exposed group.’’ [Zeig-Owens, et al. 2011] This publication led to the submission of Petition 001. In the petition, which was received shortly after publication of the ZeigOwens study, the petitioners stated they ‘‘read with great concern * * * the study conducted by the New York City Fire Department and published last week in The Lancet that indicated an elevated risk of melanoma, thyroid and prostate cancer, and non-Hodgkin lymphoma among firefighters who served at ground zero.’’ While they ‘‘feel strongly there must be a scientific basis for adding coverage for new conditions under the Zadroga Act,’’ petitioners state that ‘‘given the severity of the illnesses reported in The Lancet, we also want to make sure that this and other peer-reviewed studies linking cancers to the [September 11, 2001] attacks are evaluated as expeditiously as possible.’’ [Maloney, et al. 2011] Title XXXIII, § 3302(a)(1) establishes the STAC, and charges it to ‘‘review scientific and medical evidence and to make recommendations to the Administrator on additional WTC Program eligibility criteria and on additional WTC-related health conditions.’’ Accordingly, when asked by the Administrator to provide a recommendation on Petition 001, the STAC established evidentiary criteria and assessed the weight of the available scientific evidence provided by information sources (1), (4), and (5), described above. The STAC found support for including a number of types PO 00000 Frm 00005 Fmt 4701 Sfmt 4702 35577 of cancer based in part on evidence of increased risk reported in Zeig-Owens.6 The STAC also included a number of types of cancer based on the professional judgment of STAC members with scientific expertise, on the personal experience of some of the STAC members who were themselves WTC responders or survivors, and on comments made by the public. Unlike the explicit language in Title XXXIII, § 3312(a)(5)(A) of the PHS Act, which prescribes the standard to be used in the periodic reviews of cancer, § 3312(a)(6) does not specifically limit the type of sources upon which the Administrator may base his or her determination to propose the addition of cancer or types of cancer to the List of WTC-Related Health Conditions. In this action, the Administrator’s determination is based on the information sources used in the First Periodic Review, the NTP’s RoC, the IARC Monographs, and from all other scientific information provided by the STAC, including the Zeig-Owens study which has been added to the peerreviewed epidemiologic literature and is discussed below. As discussed extensively below, the Administrator has adopted a formal methodology to evaluate the available scientific evidence. The formal methodology follows on criteria used by the STAC in its recommendation and is presented below, in section III.D.3.7 Based upon the new methodology, the Administrator proposes to add the types of cancer identified in section III.D.4., below, to the List of WTC-Related Health Conditions. The Administrator seeks comment on the methods developed, and the application of those methods, to add cancer or a type of cancer to the List of WTC-Related Health Conditions. 6 Limitations of the Zeig-Owens study include: Limited information on specific exposures experienced by firefighters; short time for follow-up of cancer outcomes; speculation about the biological plausibility of chronic inflammation as a possible mediator between WTC-exposure and cancer outcomes; and potential unmeasured confounders. 7 The Administrator’s methodology does not incorporate the standard established in Title XXXIII, § 3312(a)(2) to determine whether an individual can be diagnosed with a WTC-related health condition—that individual standard requires a determination that the terrorist attacks ‘‘were substantially likely to be a significant factor in aggravating, contributing to, or causing the [individual’s] illness or health condition.’’ The WTC Health Program regulations at 42 CFR 88.1 define the ‘‘List of WTC-related health conditions’’ differently than a ‘‘WTC-related health condition’’ [in an individual]. For more information on the topic of certification of an individual, see Section III.D.6. below. E:\FR\FM\13JNP2.SGM 13JNP2 35578 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules 1. STAC Recommendations In response to the Administrator’s October 5, 2011 request, the STAC met on three occasions—November 9–10, 2011, February 15–16, 2012, and March 28, 2012—to deliberate and develop recommendations on Petition 001 for the Administrator’s consideration. The Administrator received the STAC recommendations on April 2, 2012. [STAC 2012] In its April 2, 2012 recommendation to the Administrator, the chair of the STAC wrote that the STAC had: conditions or to list only cancers with the strongest evidence. Some members proposed to include all cancers based on the incomplete and limited epidemiological data available to identify specific cancers, and others argued for the alternative of listing specific cancers based on best available evidence. The committee agreed to proceed by generating a list of cancers potentially related to WTC exposures based on evidence from three sources. [STAC 2012] [R]eviewed available information on cancer outcomes that may be associated with the exposures resulting from the September 11, 2001, terrorist attacks, and believes that exposures resulting from the collapse of the buildings and high-temperature fires are likely to increase the probability of developing some or all cancers. This conclusion is based primarily on the presence of approximately 70 known and potential carcinogens in the smoke, dust, volatile and semi-volatile contaminants identified at the World Trade Center site. Fifteen of these substances are classified by the International Agency for Research on Cancer (IARC) as known to cause cancer in humans, and 37 are classified by the National Toxicology Program (NTP) as reasonably anticipated to cause cancer in humans; others are classified by IARC as probable and possible carcinogens. Many of these carcinogens are genotoxic and it is therefore assumed that any level of exposure carries some risk. [STAC 2012] 1. 9/11 agents (those known and potential carcinogens identified in the New York City disaster area) with limited or sufficient evidence of carcinogenicity in humans based on International Agency for Research on Cancer (IARC) Monographs on the Evaluation of Carcinogenic Risks to Humans 8; 2. Cancers arising from regions of the respiratory and digestive tracts where inflammatory conditions, such as gastroesophageal reflux disease (GERD), have been documented; 3. Cancers for which epidemiologic studies have found some evidence of increased risk in WTC responder and survivor populations; and 4. Findings from other sources of information relevant to 9/11 exposures and the potential occurrence of cancer, including the expert judgment and personal experiences of STAC members, and comments from the public. erowe on DSK2VPTVN1PROD with PROPOSALS2 In its recommendation, the STAC also noted that ‘‘exposure data are extremely limited.’’ The STAC summarized the state of exposure assessment relevant to the terrorist attacks in New York City: No data were collected in the first 4 days after the attacks [in New York City], when the highest levels of air contaminants occurred, and the variety of samples taken on or after September 16, 2001 are insufficient to provide quantitative estimates of exposure on an individual or area level. However, the committee considers that the high prevalence of acute symptoms and chronic conditions observed in large numbers of rescue, recovery, cleanup and restoration workers and survivors, as well as qualitative descriptions of exposure conditions in downtown Manhattan, represent highly credible evidence that significant toxic exposures occurred. Furthermore, the salient biological reaction that underlies many currently recognized WTC health conditions—persistent inflammation—is now believed to be an important mechanism underlying cancer through generating DNAreactive substances, increasing cell turnover, and releasing biologically active substances that promote tumor growth, invasion and metastasis. In its recommendation to the Administrator, the STAC wrote: The committee deliberated on whether to designate all cancers as WTC-related VerDate Mar<15>2010 15:06 Jun 12, 2012 Jkt 226001 The STAC based its Petition 001 recommendation regarding the addition of certain types of cancer on evidence from four sources: Based on these four evidentiary sources, the STAC recommended to the Administrator that the following 14 cancer groups, encompassing many types of cancer, be added to the List of WTC-Related Health Conditions in 42 CFR 88.1: 1. Malignant neoplasms of the respiratory system (including nose, nasal cavity and middle ear, larynx, lung and bronchus, pleura, trachea, mediastinum, and other respiratory organs); 2. Certain cancers of the digestive system, including esophagus, stomach, colon and rectum, liver and intrahepatic bile duct, retroperitoneum, peritoneum, omentum, and mesentery; 3. Cancers of the oral cavity and pharynx, including lip, tongue, salivary gland, floor of mouth, gum and other mouth, nasopharynx, tonsil, oropharynx, hypopharynx and other oral cavity, and pharynx; 4. Soft tissue sarcomas; 5. Melanoma and non-melanoma skin cancers, including scrotal cancer; 6. Mesothelioma of the pleura and peritoneum; 7. Cancer of the ovary; 8. Cancers of the urinary tract, including urinary bladder, kidney and renal pelvis, ureter, and other urinary organs; 9. Cancer of the eye and orbit; 10. Thyroid cancer; 8 See IARC https://monographs.iarc.fr/ENG/ Monographs/PDFs/index.php. PO 00000 Frm 00006 Fmt 4701 Sfmt 4702 11. Lymphoma, leukemia, and myeloma; 12. Breast cancer; 13. Childhood cancers (all cancers diagnosed in persons less than 20 years old); and 14. Rare cancers. In its recommendation to the Administrator, the STAC also made four additional points. First, the STAC recommended that as new epidemiologic studies of 9/11exposed populations become available, the studies’ findings ‘‘be reviewed and modifications made to the list as appropriate.’’ [STAC 2012] Second, the STAC recommended that the WTC Health Program provide funding and guidelines for medical screening and early detection of cancer and appropriate counseling. [STAC 2012] Third, the STAC emphasized that although evidence of carcinogenicity of 9/11 agents from animal studies or mechanistic studies exists, because there is limited concordance between specific cancer sites affected in humans and in animals, only those substances classified based on human data are informative regarding organ sites of carcinogenicity in humans. [STAC 2012] Fourth, the STAC noted: In addition to the evidence considered by the committee to identify potential WTCrelated cancers, arguments in favor of listing cancer as a WTC-related condition include the presence of multiple exposures and mixtures with the potential to act synergistically and to produce unexpected health effects; the major gaps in the data with respect to the range and levels of carcinogens, the potential for heterogeneous exposures and hot spots representing exceptionally high or unique exposures both on the WTC site and in surrounding communities, the potential for bioaccumulation of some of the compounds, limitations of testing for carcinogenicity of many of the 287 agents and chemical groups cited in the first NIOSH Periodic Review, and the large volume of toxic materials present in the WTC towers. [STAC 2012] Finally, the STAC stated that [A]lthough acknowledging some lack of certainty in the evidence for targeting specific organs or organ site groupings as WTC-related, the majority of the committee agreed that recommending the specified cancer sites and site groupings was based on a sound scientific rationale and the best evidence available to date. [STAC 2012] 2. Administrator’s Review of Available Scientific Information and the STAC’s Recommendations The Administrator agrees with the STAC that individual exposure assessment information arising from the terrorist attacks is extremely limited and that its absence impairs definitive E:\FR\FM\13JNP2.SGM 13JNP2 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules scientific analysis of the relationship between exposures arising from the attacks and the occurrence of any specific type of cancer. Also absent at the present time are multiple epidemiologic studies of cancer in exposed responders and survivors which definitively support an association between 9/11 exposures and specific types of cancer that would meet generally well-accepted criteria indicating that the association is a causal one. As noted in the First Periodic Review: Drawing causal inferences about exposures resulting from the September 11, 2001, terrorist attacks and the observation of cancer cases in responders and survivors is especially challenging since cancer is not a rare disease. In the United States, the probability that a person will develop cancer during their lifetime is one in two for men and one in three for women [ACS 2010]. This ‘background’ rate of cancer development would be expected in responders and survivors even if the September 11, 2001, terrorist attacks had never occurred. Determining, then, if the September 11, 2001, exposures are contributing to an additional burden of cancer in responders and survivors is a scientific challenge. [NIOSH 2011] erowe on DSK2VPTVN1PROD with PROPOSALS2 Also noted in the First Periodic Review, an important framework used by epidemiologists to assess the causal nature of an observed association is the ‘‘Bradford Hill criteria.’’ [Hill 1965] The criteria are not intended to be a rigorous checklist, although they are often viewed in that way. None of the nine Bradford Hill criteria are alone sufficient to establish causation; together they can provide a starting point in evaluating whether an observed association is indeed a causal one. Five of those criteria are used by the Administrator in this rulemaking to evaluate evidence of a causal relationship between 9/11 exposures and a type of cancer: Strength of the association reported in the study between exposure agents and the type of cancer; consistency of the findings across multiple studies of exposed populations; biological gradient or doseresponse relationship between exposures and the type of cancer; and plausibility and coherence of the findings with known facts about the biology of the type of cancer.9 9 Four Bradford Hill criteria were not considered because, while useful in considering all sources of information, as the NTP and IARC reviews do, they have limited value when considering only the cancer epidemiologic studies of the 9/11-exposed population. Analogy establishes that if one exposure causes cancer, then a similar exposure should cause a similar cancer. This criterion is most useful with a large body of evidence. Specificity is not useful since many cancers are caused by multiple exposures. Temporal relationship establishes that exposure always precedes the VerDate Mar<15>2010 15:06 Jun 12, 2012 Jkt 226001 Given the limitations of the current peer-reviewed scientific literature on cancer and 9/11 exposures, the Administrator agrees with the approaches the STAC used to recommend cancers for addition to the List of WTC-Related Health Conditions, but seeks additional information or published studies that are informative on the subject of adding certain types of cancer to the List of WTC-Related Health Conditions (Section III.D.5). First, the STAC approach recommended including types of cancer for which IARC has categorized known 9/11 agents as having sufficient (Group 1 carcinogens) or limited (Group 2A probable carcinogens and Group 2B possible carcinogens) evidence for human carcinogenicity. IARC describes the evidence for carcinogenicity in humans as sufficient when a causal relationship has been established between exposure to the agent and human cancer. That is, a positive relationship has been observed between the exposure and a type of cancer in studies in which chance, bias, and confounding could be ruled out with reasonable confidence. IARC describes the evidence as limited when a positive association has been observed between the exposure and the cancer, and the IARC working group considered a causal interpretation to be credible but could not rule out chance, bias, or confounding with reasonable confidence. The Administrator has made the judgment that an IARC determination that the epidemiologic evidence for a 9/11 agent is sufficient or limited for a type of cancer qualifies the type for inclusion in the List of WTCRelated Health Conditions. The Administrator has further determined that evidence of exposure to 9/11 agents at any of the three sites—the New York City disaster area, the Pentagon, or Shanksville, Pennsylvania—qualifies for proposing the inclusion of a cancer type. The Administrator has also determined that cancers at sites in close anatomical proximity to sites proposed for inclusion under Method 3 (described in III.D.3., below) may also be added since it is often difficult to distinguish the cancer’s anatomical origin especially when cancers from closely proximate sites are histopathologically indistinguishable. Second, the STAC drew attention to types of cancers which arise in regions of the respiratory and digestive tracts where inflammatory conditions have been documented, some of which are outcome. Experiment establishes that the condition can be altered (prevented or ameliorated) by an appropriate experimental regimen. PO 00000 Frm 00007 Fmt 4701 Sfmt 4702 35579 health conditions already on the List of WTC-Related Health Conditions, including WTC-related health conditions of the upper and lower airway, and gastroesophageal reflux disease (GERD). The STAC cited several peer-review scientific publications about current scientific thinking on the relationship between inflammation and cancer. The Administrator agrees that a type of cancer may be added to the List if there is well-established scientific support for a causal relationship between that cancer and a WTC-related health condition already on the List. For example, when a WTC-related health condition (e.g., GERD) has been determined to be causally associated by means of multiple epidemiologic studies with the development of a particular type of cancer (e.g., esophageal cancer), the cancer type can be added to the List of WTC-Related Health Conditions. Third, the STAC included types of cancer based on an epidemiologic cohort study that identified a modest effect of WTC exposure for all cancers combined in exposed FDNY firefighters. [Zeig-Owens, et al. 2011] The STAC reviewed the Zeig-Owens study, which reported a 32 percent increase in the incidence of cancer among 9/11exposed firefighters compared with nonexposed firefighters (Standardized Incidence Ratio (SIR) 1.32; 95% Confidence Interval (CI) 1.07–1.62). After correcting for possible surveillance bias, the increase was reduced to 21 percent (SIR 1.21; 95% CI 0.98–1.49). [Zeig-Owens, et al. 2011] The Administrator believes that it is plausible that the overall rate of cancer cases in FDNY firefighters may have increased following those firefighters’ exposures to 9/11 agents, but agrees with the authors of the Zeig-Owens study who noted there could be other explanations for the findings: We remain cautious in our interpretation of these findings because the time interval since 9/11 is short for cancer outcomes, the recorded excess of cancers is not limited to specific sites, and the biological plausibility of chronic inflammation as a possible mediator between WTC-exposure and cancer outcomes remains speculative. [Zeig-Owens, et al. 2011] The Administrator notes that the STAC recommended inclusion of five site-specific cancer types based on findings in the Zeig-Owens study when the incidence of certain types of cancer in exposed firefighters was compared to non-exposed firefighters. These cancers are stomach, colon (excluding rectum), melanoma, non-Hodgkin lymphoma, and thyroid. The Zeig-Owens study is E:\FR\FM\13JNP2.SGM 13JNP2 35580 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules erowe on DSK2VPTVN1PROD with PROPOSALS2 the only published study of a 9/11exposed population currently available for review and presents the risk estimates in multiple ways. The Administrator agrees with the authors of the Zeig-Owens study, who note that ‘‘[s]ite-specific cancer SIR ratios (exposed versus non-exposed) were not significantly increased, although we noted a trend towards an increase in ten of 15 sites.’’ [Zeig-Owens, et al., 2011] The Administrator placed a different emphasis on an interpretation of the statistical significance of the findings than did the STAC, and considered only the cancer risk estimates that were corrected for surveillance bias and that utilized the more similar referent group, unexposed firefighters. The Administrator has made the judgment that only statistically significant findings will be used to support the proposed inclusion of a type of cancer using Method 1, however cancers can be added under Methods 2, 3, 4 (see III.D.3., below). At the same time, the Administrator understands the interpretation of the findings from the Zeig-Owens study about site-specific cancer rates used by the STAC to recommend that stomach, colon (excluding rectum), melanoma, nonHodgkin lymphoma, and thyroid be included on the List of WTC-Related Health Conditions. Fourth, the STAC also considered findings from sources of information relevant to 9/11 exposures (including the expert judgment and personal experiences of STAC members, and comments from the public) and the potential occurrence of cancer. The Administrator considered the approaches used in the First Periodic Review and also the approaches used by the STAC to evaluate the available scientific evidence. In order to determine whether to propose a type of cancer for inclusion on the List, the Administrator sought to develop a method that would assist with characterizing 9/11 exposures and the likelihood of developing cancer or a type of cancer. One approach considered was to rely exclusively on a weight of evidence evaluation of the epidemiologic literature. In this VerDate Mar<15>2010 15:06 Jun 12, 2012 Jkt 226001 approach, accumulated evidence from four types of studies (i.e., cohort, cross sectional, case-control, and case series) would be evaluated to develop insight into historic exposures and the risk of developing cancer or a type of cancer. Utilization of this approach would be consistent with the approach described by the Administrator in the First Periodic Review of cancer, a portion of the methodology adopted by the STAC, and Method 1 described in section III.D.3., below. However, evaluation of the epidemiologic literature is limited by both the lack of exposure data available for the days immediately after the collapse of the WTC Towers and the insufficient time for differences in cancer incidence and mortality to be detected in 9/11-exposed populations. Additional approaches were adopted to compensate for both of these limitations. Method 2 recognizes that certain WTC-related health conditions may progress to cancer. Method 3 is a qualitative approach that uses concordance between two authoritative reviews of peer-reviewed literature (NTP and IARC) as a threshold to characterize the likelihood of 9/11 agents to cause cancer in humans. Method 4 relies on the work of the STAC in providing a reasonable basis for adding a type of cancer in addition to those identified under Methods 1–3. 3. Methods Used by the Administrator To Determine Whether To Add Cancer or Types of Cancer to the List of WTCRelated Health Conditions The Administrator developed the following hierarchy of methods for determining whether to add cancer or types of cancer to the List of WTCRelated Health Conditions in 42 CFR 88.1. In determining whether to propose that a type of a cancer be included on the List, a review of the evidence must demonstrate fulfillment of at least one of the following four methods: D Method 1. Epidemiologic Studies of September 11, 2001 Exposed Populations. A type of cancer may be added to the List if published, peer-reviewed epidemiologic evidence supports a causal association between 9/11 exposures and the cancer type. The following criteria extrapolated from the Bradford Hill criteria will be used to evaluate PO 00000 Frm 00008 Fmt 4701 Sfmt 4702 the evidence of the exposure-cancer relationship: • strength of the association between a 9/ 11 exposure and a health effect (including the magnitude of the effect and statistical significance); • consistency of the findings across multiple studies; • biological gradient, or dose-response relationships between 9/11 exposures and the cancer type; and • plausibility and coherence with known facts about the biology of the cancer type. If only a single published epidemiologic study is available for review, the consistency of findings cannot be evaluated and strength of association will necessarily place greater emphasis on statistical significance than on the magnitude of the effect. D 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 epidemiologic studies for a causal association between that cancer and a condition already on the List of WTC-Related Health Conditions. D Method 3. Review of Evaluations of Carcinogenicity in Humans. A type of cancer may be added to the List only if both of the following criteria for Method 3 are satisfied: 3A. Published Exposure Assessment Information. 9/11 agents were reported in a published, peer-reviewed exposure assessment study of responders or survivors who were present in either the New York City disaster area as defined in 42 CFR 88.1, or at the Pentagon, or in Shanksville, Pennsylvania; and 3B. Evaluation of Carcinogenicity in Humans from Scientific Studies. NTP has determined that the 9/11 agent is known to be a human carcinogen or is reasonably anticipated to be a human carcinogen, and IARC has determined there is sufficient or limited evidence that the 9/11 agent causes a type of cancer. D Method 4. Review of Information Provided by the WTC Health Program Scientific/Technical Advisory Committee. A type of cancer may be added to the List if the STAC has provided a reasonable basis for adding a type of cancer and the basis for inclusion does not meet the criteria for Method 1, Method 2, or Method 3. The Administrator invites comment on this methodology and its implementation. The following schematic illustrates the methodology used in this rulemaking. BILLING CODE P E:\FR\FM\13JNP2.SGM 13JNP2 VerDate Mar<15>2010 18:43 Jun 12, 2012 Jkt 226001 PO 00000 Frm 00009 Fmt 4701 Sfmt 4725 E:\FR\FM\13JNP2.SGM 13JNP2 35581 EP13JN12.999</GPH> erowe on DSK2VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules 35582 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules 4. Administrator’s Determination Concerning Petition 001 erowe on DSK2VPTVN1PROD with PROPOSALS2 Using the evidentiary standards established above for inclusion of a cancer on the List of WTC-Related Health Conditions in 42 CFR 88.1, the Administrator reviewed the scientific VerDate Mar<15>2010 15:06 Jun 12, 2012 Jkt 226001 evidence referenced in the First Periodic Review [NIOSH 2011], Petition 001, and in the STAC’s April 2, 2012 recommendations to the Administrator.10 Accordingly, the Administrator proposes to add the specific types of cancers in Table A, below, to the List of WTC-Related Health Conditions in 42 CFR 88.1. 10 Transcripts and recordings of the STAC meetings are available in NIOSH Docket 248 https:// www.cdc.gov/niosh/docket/archive/docket248.html. Accessed April 20, 2012. PO 00000 Frm 00010 Fmt 4701 Sfmt 4702 BILLING CODE P E:\FR\FM\13JNP2.SGM 13JNP2 VerDate Mar<15>2010 15:06 Jun 12, 2012 Jkt 226001 PO 00000 Frm 00011 Fmt 4701 Sfmt 4725 E:\FR\FM\13JNP2.SGM 13JNP2 35583 EP13JN12.003</GPH> erowe on DSK2VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules VerDate Mar<15>2010 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules 15:06 Jun 12, 2012 Jkt 226001 PO 00000 Frm 00012 Fmt 4701 Sfmt 4725 E:\FR\FM\13JNP2.SGM 13JNP2 EP13JN12.004</GPH> erowe on DSK2VPTVN1PROD with PROPOSALS2 35584 VerDate Mar<15>2010 15:06 Jun 12, 2012 Jkt 226001 PO 00000 Frm 00013 Fmt 4701 Sfmt 4725 E:\FR\FM\13JNP2.SGM 13JNP2 35585 EP13JN12.005</GPH> erowe on DSK2VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules VerDate Mar<15>2010 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules 15:06 Jun 12, 2012 Jkt 226001 PO 00000 Frm 00014 Fmt 4701 Sfmt 4725 E:\FR\FM\13JNP2.SGM 13JNP2 EP13JN12.006</GPH> erowe on DSK2VPTVN1PROD with PROPOSALS2 35586 VerDate Mar<15>2010 15:06 Jun 12, 2012 Jkt 226001 PO 00000 Frm 00015 Fmt 4701 Sfmt 4725 E:\FR\FM\13JNP2.SGM 13JNP2 35587 EP13JN12.007</GPH> erowe on DSK2VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules VerDate Mar<15>2010 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules 15:06 Jun 12, 2012 Jkt 226001 PO 00000 Frm 00016 Fmt 4701 Sfmt 4725 E:\FR\FM\13JNP2.SGM 13JNP2 EP13JN12.008</GPH> erowe on DSK2VPTVN1PROD with PROPOSALS2 35588 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules erowe on DSK2VPTVN1PROD with PROPOSALS2 5. Explanations for Adding Certain Types of Cancer to the List of WTCRelated Health Conditions The Administrator’s rationale and the method relied upon for inclusion of each type of cancer are offered below. The types of cancer proposed by the Administrator are grouped by anatomical region, for ease of discussion, and are identified by their individual ICD–10 code.11 [WHO 1997] The ICD–9 codes associated with each specific type of cancer are identified in the regulatory text. Cancers of the Head and Neck. For the reasons discussed below for each type, the Administrator proposes the inclusion of cancers found in the lip, tongue, salivary gland, floor of mouth, gum and other mouth, tonsil, oropharynx, nasopharynx, hypopharynx, other oral cavity and pharynx, nasal cavity, accessory sinuses, and the larynx. D Malignant neoplasms of the lip [C00], tongue [C01, C02], salivary gland [C07, C08], floor of mouth [C04], gum and other mouth [C03, C05, C06], tonsil [C09], oropharynx [C10], hypopharynx [C12, C13], other oral cavity and pharynx [C14]: (Method 3) IARC has determined that there is limited evidence that asbestos causes cancer of other oral cavity and pharynx. The review of published exposure assessment studies has not identified any 9/11 exposure agent associated with cancers of the lip, tongue, salivary gland, floor of mouth, gum and other mouth, tonsil, oropharynx, and hypopharynx. The Administrator has determined that the types of cancer proposed to be added in the Head and Neck group under Method 3 share an anatomic continuum and can be included with other head and neck group types of cancer. D Malignant neoplasm of the nasopharynx [C11]: (Method 3) The review of published exposure assessment studies identified formaldehyde as present in the New York City disaster area. [COPC 2003] IARC has determined that results of epidemiologic studies of exposure by inhalation to formaldehyde provide sufficient epidemiological evidence that formaldehyde causes nasopharyngeal cancer in humans. [IARC 2012c] D Malignant neoplasms of the nasal cavity [C30] and accessory sinuses [C31]: (Method 3) The review of 11 The International Classification of Diseases (ICD) is used to code and classify injuries and diseases and their signs, symptoms, and external causes for statistical presentation, disease analysis, hospital records indexing, and medical billing reimbursement. VerDate Mar<15>2010 15:06 Jun 12, 2012 Jkt 226001 published exposure assessment studies identified nickel and hexavalent chromium compounds as present in the New York City disaster area. [Lioy, et al. 2002; COPC 2003; Lorber, et al. 2007] IARC has determined that results of epidemiologic studies of exposure by inhalation provide sufficient epidemiological evidence that nickel compounds cause cancer of the nose and nasal sinuses in humans. [IARC 2012a] D Malignant neoplasm of the larynx [C32]: (Method 3) The review of published exposure assessment studies identified asbestos and sulfuric acid as present in the New York City disaster area. [Lioy, et al. 2002; COPC 2003; Lorber, et al. 2007] IARC has determined that results of epidemiologic studies of exposure by inhalation provide sufficient epidemiological evidence that all forms of asbestos (chrysotile, crocidolite, amosite, tremolite, actinolite, and anthophyllite) cause cancer of the larynx in humans. [IARC 2012a] IARC has determined that the results of epidemiologic studies of exposure by inhalation provide sufficient epidemiological evidence that strong inorganic acids including sulfuric acid cause cancer of the larynx. Cancers of the Digestive System. For the reasons discussed below for each site, the Administrator proposes the inclusion of cancers found in the esophagus; stomach; colon and rectum; liver and intrahepatic bile duct; retroperitoneum; and peritoneum. D Malignant neoplasms of the esophagus [C15]: (Method 2) There is well-accepted evidence that symptoms of an already-covered WTC-related health condition—gastroesophageal reflux disease (GERD)—increases the risk of developing esophageal cancer. Persons with recurring symptoms of reflux have an eightfold increase in the risk of esophageal adenocarcinoma. [Lagergren, et al., 1999] D Malignant neoplasm of the stomach [C16]: (Method 3) The review of published exposure studies identified asbestos and inorganic compounds of lead as present in the New York City disaster area. [COPC 2003] IARC has determined that the results of epidemiologic studies of exposure by inhalation and/or ingestion provide limited evidence that all forms of asbestos (chrysotile, crocidolite, amosite, tremolite, actinolite, and anthophyllite) cause cancer of the stomach in humans. [IARC 2012a] IARC has also determined that there is limited evidence that exposure to inorganic lead causes cancer of the stomach. [Cogliano, et al. 2011; IARC 2006] PO 00000 Frm 00017 Fmt 4701 Sfmt 4702 35589 D Malignant neoplasms of the colon (and rectum) [C18, C19, C20, C26.0]: (Method 3) The review of published exposure assessment studies identified asbestos as present in the New York City disaster area. [COPC 2003] IARC has determined that the results of epidemiologic studies of exposure by inhalation provide limited epidemiologic evidence that all forms of asbestos (chrysotile, crocidolite, amosite, tremolite, actinolite, and anthophyllite) cause cancer of the colon and rectum in humans. [Cogliano, et al. 2011] D Malignant neoplasms of the liver and intrahepatic bile duct [C22]: (Method 3) The review of published exposure assessment studies identified vinyl chloride, arsenic and inorganic arsenic compounds, polychlorinated biphenyls, and trichloroethylene as present in the New York City disaster area. [COPC 2003] Arsenic and vinyl chloride are classified as known human carcinogens by IARC and NTP. For arsenic, IARC identifies the evidence for causality of cancer of the liver and intrahepatic duct as limited and classifies the evidence for carcinogenicity of vinyl chloride as sufficient to cause angiosarcomas of the liver and hepatocellular carcinomas. For polychlorinated biphenyls and trichloroethylene exposure, IARC characterizes the evidence as limited for causation of cancer of the liver. [Cogliano, et al. 2011] D Malignant neoplasms of the retroperitoneum and peritoneum [C48]: The review of published exposure assessment studies has not associated any 9/11 agent with cancer of the retroperitoneum, peritoneum, omentum, and mesentery. The Administrator has determined that the types of cancer proposed to be added in the digestive system under Method 3 share an anatomic continuum and can be included together with other added digestive system types of cancer. Cancers of the Respiratory System. For the reasons discussed below for each site, the Administrator proposes the inclusion of cancers found in the trachea; bronchus and lung; heart; and other and ill-defined sites in the respiratory system and intrathoracic organs. D Malignant neoplasms of the trachea [C33]; bronchus and lung [C34]; heart, mediastinum and pleura [C38]; and other ill-defined sites in the respiratory system and intrathoracic organs [C39]: (Method 3) The review of published exposure assessment studies identified arsenic, asbestos, beryllium, cadmium, nickel, and silica as present in the New York City disaster area. [COPC 2003; E:\FR\FM\13JNP2.SGM 13JNP2 erowe on DSK2VPTVN1PROD with PROPOSALS2 35590 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules Lioy, et al. 2002; Wallingford and Snyder 2001] IARC has determined that there is sufficient evidence in humans for the carcinogenicity of mixed exposure to inorganic arsenic compounds, including arsenic trioxide, arsenite, and arsenate. Inorganic arsenic compounds, including arsenic trioxide, arsenite, and arsenate, cause cancer of the lung and intrathoracic organs. [IARC 2012a] IARC has determined that there is sufficient evidence in humans that inhalation exposure to all forms of asbestos (chrysotile, crocidolite, amosite, tremolite, actinolite, and anthophyllite) causes cancer of the lung and intrathoracic organs (including C33, C34, C38, and C39). IARC has determined that results of epidemiologic studies of exposure by inhalation provide sufficient epidemiological evidence that beryllium and beryllium compounds cause cancer of the lung and intrathoracic organs. [IARC 2012a] IARC has determined that results of epidemiologic studies of exposure by inhalation provide sufficient epidemiologic evidence that cadmium and cadmium compounds cause cancer of the lung and intrathoracic organs in humans. [Cogliano, et al. 2011; IARC 2012a] IARC has determined that results of epidemiologic studies of exposure by inhalation provide sufficient epidemiologic evidence that nickel compounds and nickel metal cause cancer of the lung and intrathoracic organs in humans. [Cogliano, et al. 2011; IARC 2012a] IARC has determined that results of epidemiologic studies of exposure by inhalation provide sufficient epidemiologic evidence that crystalline silica in the form of quartz causes cancer of the lung and intrathoracic organs in humans. IARC has also determined that there is sufficient evidence in humans that soot causes cancer of the lung. [IARC 2012c] In addition, IARC has determined that strong inorganic acids, welding fumes, diesel exhaust and 2,3,7,8tetrachlorodibenzo-para-dioxin have limited evidence for causing cancer of the respiratory system. Cancer of the Mesothelium. For the reasons discussed below, the Administrator proposes the inclusion of cancer found in the mesothelium. D Mesothelioma [C45]: (Method 3) The review of published exposure assessment studies identified asbestos as present in the New York City disaster area. [Lioy, et al. 2002; COPC 2003; Lorber, et al. 2007] IARC has determined that results of epidemiologic studies of exposure by inhalation provide sufficient epidemiologic evidence that all forms of asbestos (chrysotile, crocidolite, amosite, VerDate Mar<15>2010 15:06 Jun 12, 2012 Jkt 226001 tremolite, actinolite, and anthophyllite) cause mesothelioma in humans. [IARC 2012a] Cancer of the Soft Tissues. For the reasons discussed below, the Administrator proposes the inclusion of cancer found in the soft tissues. D Malignant neoplasm of peripheral nerves and autonomic nervous system [C47) and malignant neoplasm of other connective and soft tissue [C49]: (Method 3) The review of published exposure assessment studies identified 2,3,7,8-tetrachlorodibenzo-para-dioxin as present in the New York City disaster area. [COPC 2003] IARC has found limited evidence for increased risk of soft tissue sarcoma associated with exposure to 2,3,7,8-tetrachlorodibenzopara-dioxin. Cancer of the Skin (non-melanoma and melanoma), including scrotum. For the reasons discussed below, the Administrator proposes the inclusion of cancer found in the skin. D Other malignant neoplasms of skin (non-melanoma) [C44], malignant melanoma of skin [C43], and malignant neoplasm of scrotum [C63.2]: (Method 3 and 4) The review of published exposure assessment studies identified arsenic and soot as present in the New York City disaster area [COPC 2033). Both NTP and IARC determined that arsenic [IARC 2012c] and occupational exposure to soot [IARC 2012c] are known human carcinogens and that there is sufficient evidence that they cause non-melanoma skin cancer. The STAC recommended including melanoma based on its interpretation of the Zeig-Owens study. The STAC stated: the Zeig-Owens study found a statistically significant increase in melanoma among exposed firefighters compared to the general population; the Standardized Incidence Ratio (SIR) was slightly larger but not significant when compared to non-exposed firefighters. No adjustment for surveillance bias was reported for malignant melanoma, although early detection through medical surveillance is likely. Because the Zeig-Owens finding for melanoma was not statistically significant (when compared to nonexposed firefighters), the Administrator cannot propose to add melanoma to the List of WTC-Related Health Conditions based on Method 1. Melanoma is proposed for inclusion based on Method 4. The Administrator will continue to monitor cohort studies that address sitespecific cancers such as melanoma in 9/ 11-exposed populations. Cancer of the Breast. For the reasons discussed below, the Administrator proposes the inclusion of cancer found in the breast. PO 00000 Frm 00018 Fmt 4701 Sfmt 4702 D Malignant neoplasm of the breast [C50]: (Method 4) The STAC recommended inclusion of breast cancer based on the professional judgment and personal experience of STAC members and on public comments. The STAC stated There is evidence of PCB exposures to WTC responders and survivors based on air samples, window film samples and one biomonitoring study. Studies have linked total and congener-specific PCB levels in serum and adipose tissue with breast cancer, although evidence has been conflicting. PCBs and some other substances at the WTC site are endocrine disruptors. Breast cancer risks are highly related to hormonal factors, including endogenous and exogenous estrogens, and could plausibly be affected by endocrine disruptors. A recent study found that PCBs enhanced the metastatic properties of breast cancer cells by activating rhoassociated kinase. Shiftwork involving circadian rhythm disruption has been classified by IARC as probably carcinogenic to humans, based in part on epidemiologic studies associating shiftwork with increased risks of breast cancer. Both shiftwork and long shifts were common for workers involved in rescue, recovery, clean up, restoration and other activities at the WTC site. [STAC 2012, references omitted] The STAC further noted the lack of opportunity to find evidence for breast cancer among exposed occupations because so few women work in the occupations mainly involved with response work in the New York City disaster area, at the Pentagon, and in Shanksville, Pennsylvania. Shiftwork has been classified by IARC as probably carcinogenic based in part on limited evidence in humans demonstrating an increased risk of breast cancer among shift workers. IARC notes that mechanistic studies suggest that exposure to light at night may increase the risk of breast cancer by suppressing the normal nocturnal production of melatonin, which in turn, may alter gene expression in cancerrelated pathways. [Straif, et al. 2007] NTP has not yet examined the evidence for an association of shiftwork and breast cancer, however, NTP recently requested comment from the public whether shiftwork involving light at night should be nominated for possible review for future editions of the RoC. [NTP 2012] The Administrator is not aware of any published exposure assessment study of shiftwork and 9/11, although the Administrator is aware that extended work hours for many responders occurred at all three 9/11 sites over several months. The Administrator proposes to add breast cancer to the List of WTC-Related Health Conditions based on Method 4, and continues to seek information about E:\FR\FM\13JNP2.SGM 13JNP2 erowe on DSK2VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules any exposures in the New York City disaster area, at the Pentagon, or in Shanksville, Pennsylvania that would further support adding breast cancer to the List of WTC-Related Health Conditions. Cancer of the Female Reproductive Organs. For the reasons discussed below, the Administrator proposes the inclusion of cancer found in the ovary. D Malignant neoplasm of the ovary [C56]: (Method 3) The review of published exposure assessment studies identified asbestos as present in the New York City disaster area. [Lioy, et al. 2002; COPC 2003; Lorber, et al. 2007] IARC has determined that results of epidemiologic studies of exposure by inhalation provide sufficient epidemiological evidence that all forms of asbestos (chrysotile, crocidolite, amosite, tremolite, actinolite, and anthophyllite) cause cancer of the ovary in humans, based on five strongly positive cohort mortality studies of women with heavy occupational exposure to asbestos. [IARC 2012a] Cancers of the Urinary System. For the reasons discussed below, the Administrator proposes the inclusion of cancer found in the urinary bladder, kidney, renal pelvis, ureter and other urinary organs. D Malignant neoplasm of the urinary bladder [C67]: (Method 3) The review of published exposure assessment studies identified arsenic, inorganic arsenic, diesel exhaust and soot as present in the New York City disaster area. Both NTP and IARC determined that arsenic is known to be a human carcinogen [IARC 2012a], and IARC has determined there is limited evidence that diesel engine exhaust and soot cause cancer of the urinary bladder. D Malignant neoplasm of the kidney [C64]: (Method 3) The review of published exposure assessment studies identified arsenic, inorganic arsenic compounds, and cadmium and cadmium compounds as present in the New York City disaster area. [COPC 2003] The evidence for carcinogenicity of inorganic arsenic compounds and cadmium are categorized as limited by IARC and NTP, which meets the requirements for inclusion based on Method 3. D Malignant neoplasm of the renal pelvis, ureter and other urinary organs [C65, C66 and C68]: (Method 3) The Administrator has determined that the types of cancer proposed to be added in the urinary system under Method 3 share an anatomic continuum and can be included together with other added urinary system types of cancer. Cancer of the Eye and Orbit. For the reasons discussed below, the VerDate Mar<15>2010 15:06 Jun 12, 2012 Jkt 226001 Administrator proposes the inclusion of cancer found in the eye and orbit. D Malignant neoplasm of the eye and orbit [C69]: (Method 4) Cancers of the eye and eye orbit are not addressed in the only published epidemiologic study of September 11, 2001 exposed populations to date (Method 1). The STAC noted that eye irritation from dust was ubiquitous in the New York City disaster area and postulated an association between irritation from dust and cancers of the eye and eye orbit. However, irritation has not been associated with cancers of the eye and eye orbit in the published literature (Method 2). The STAC also noted that IARC determined the evidence is sufficient for welding to cause ocular melanoma by occupational exposure to ultraviolet radiation. The review of published exposure assessment studies identified metal cutting as occurring in the New York City disaster area, but the exposure assessment literature is silent about welding involving ultraviolet light exposure. The Administrator proposes to add cancer of the eye and orbit based on Method 4, but seeks information on welding activities in the New York City disaster area, at the Pentagon, or in Shanksville, Pennsylvania, including information on the types of welding, frequency, and locations to better understand the nature of the exposures that occurred that could further support adding cancer of the eye and orbit to the List of WTC-Related Health Conditions. Cancer of the Thyroid. For the reasons discussed below, the Administrator proposes the inclusion of cancer found in the thyroid. D Malignant neoplasm of thyroid gland [C73]: (Method 3) The STAC recommended thyroid cancer for inclusion, noting that it has not been associated with any of the agents known to be present in the New York City disaster area. The primary evidence that the STAC based its recommendation for inclusion on was ‘‘an excess in risk [for thyroid cancer] from the Zeig-Owens study.’’ [STAC 2012] Even though the Administrator views the significance of the Zeig-Owens finding relating to thyroid cancer differently than does the STAC, the Administrator proposes to add thyroid cancer to the List of WTCRelated Health Conditions based on Method 4. The Administrator will continue to monitor cohort studies that address site-specific cancer in 9/11exposed populations. Cancers of the Blood and Lymphoid Tissue. For the reasons discussed below for each type, the Administrator proposes adding malignant neoplasms of the blood and lymphoid tissues, PO 00000 Frm 00019 Fmt 4701 Sfmt 4702 35591 including, but not limited to, lymphoma, leukemia, and myeloma. D Hodgkin’s disease [C81]; follicular [nodular] non-Hodgkin lymphoma [C82]; diffuse non-Hodgkin lymphoma [C83]; peripheral and cutaneous T-cell lymphomas [C84]; other and unspecified types of non-Hodgkin lymphoma [C85]; malignant immunoproliferative diseases [C88]; multiple myeloma and malignant plasma cell neoplasms [C90]; lymphoid leukemia [C91]; myeloid leukemia [C92]; monocytic leukemia [C93]; other leukemias of specified cell type [C94]; leukemia of unspecified cell type [C95]; other and unspecified malignant neoplasms of lymphoid, hematopoietic and related tissue [C96]: (Method 3) The review of published exposure assessment studies identified benzene [Lorber, et al. 2007; Wallingford and Snyder 2001], 1,3-butadiene [Lorber, et al. 2007; Wallingford and Snyder 2001], and formaldehyde [COPC 2003] as present in the New York City disaster area. IARC determined that there is sufficient evidence that exposure to 1,3butadiene causes cancer of the hematolymphatic organs. IARC considers hematolymphatic cancers attributable both to leukemia and malignant lymphoma. The IARC working group recognized that the epidemiological evidence for an association with specific subtypes of hematolymphatic cancers is weaker, but when malignant lymphomas and leukemias are distinguished, the evidence is strongest for leukemia. [IARC, 2012c] IARC also determined that there is sufficient evidence that exposure to benzene causes acute myeloid leukemia and acute nonlymphocytic leukemia. [Cogliano, et al. 2011; IARC 2012c] IARC has determined that results of epidemiological studies of exposure by inhalation provide sufficient epidemiological evidence that formaldehyde causes leukemia in humans. [Cogliano, et al. 2011; IARC 2012c] In addition, IARC has determined that there is limited evidence in humans that styrene, tetrachloroethylene, trichloroethylene, and 2,3,7,8-tetrachlorodibenzo-paradioxin cause leukemia. For the reasons discussed above, the Administrator intends to include all hematolymphatic cancers. Childhood Cancers. (Method 4) The STAC recommended that childhood cancers be included on the List of WTCRelated Health Conditions based on the ‘‘unique vulnerability of children to synthetic chemicals’’ and that ‘‘childhood cancers are rare and excess risks are not likely to be detectable in the small number of children being E:\FR\FM\13JNP2.SGM 13JNP2 erowe on DSK2VPTVN1PROD with PROPOSALS2 35592 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules followed in epidemiologic studies.’’ [STAC 2012] The STAC defines childhood cancers as all cancers diagnosed in persons less than 20 years old. The most common types of childhood cancers are hematopoietic, bone, kidney, sarcomas, eye, and brain cancers. Childhood cancers involving the blood and lymphoid tissues, kidney, sarcomas, and eye cancers have already been added to the List and are described elsewhere in Section III.D.5. The Administrator proposes to add childhood cancers—any type of cancer occurring in a person less than 20 years of age—to the List of WTC-Related Health Conditions based on Method 4. The Administrator will continue to monitor cohort studies that address sitespecific cancer in 9/11-exposed populations of children less than 20 years of age. Rare Cancers. (Method 4) The STAC recommended that rare cancers be included in the List of WTC-Related Health Conditions but noted that there is no uniform definition a rare cancer. The STAC also recommended that ‘‘definitions be based on age-specific incidence rates by gender, decade of age, site and histology. Site/histology combinations to be considered as unique cancers should be determined a priori in consultation with appropriate experts.’’ The Rare Diseases Act of 2002 defines a rare disease as one affecting ‘‘small patient populations, typically populations smaller than 200,000 individuals in the United States.’’ 12 The National Cancer Institute notes that ‘‘there are some anatomic sites in which cancer rarely occurs.’’ [Young, et al. 2007] For a limited population like that of the WTC Health Program, cancers that are considered rare based on occurrence rates in the U.S. population will be rare cancers for the 9/11-exposed populations. The Administrator proposes to add rare cancers—any type of cancer affecting populations smaller than 200,000 individuals in the United States, i.e., occurring at an incidence rate less than 0.08 percent of the U.S. population—to the List of WTC-Related Health Conditions based on Method 4 and will consult with appropriate experts as recommended by the STAC. The Administrator also seeks information about rare cancers from the public. The Administrator will continue to review and evaluate the scientific evidence available to determine whether these types and any other types of cancer should be included in the List. 12 Rare Diseases Act of 2002 (Pub. L. 107–208), codified in Title IV, § 404f(c) of the PHS Act (42 U.S.C. 283h(c)). VerDate Mar<15>2010 15:06 Jun 12, 2012 Jkt 226001 These reviews will be published in the periodic reviews of cancer. Petitions to add types of cancer may also be filed with the Administrator. In the event additional studies are published prior to the issuance of a final rule regarding the subject of this notice of proposed rulemaking, the Administrator will consider those studies as appropriate in the process of developing a final rule. 6. Certification and Treatment of WTCRelated Health Conditions Including Types of Cancer In order for an individual enrolled as a WTC responder or survivor to obtain coverage for treatment of any health condition on the List of WTC-Related Health Conditions, including any of type of cancer added to the List, a twostep process must be satisfied. First, a physician at a Clinical Center of Excellence or in the nationwide provider network must make a determination that the particular type of cancer for which the responder or survivor seeks treatment coverage is both: (1) On the List of WTC-Related Health Conditions; and that (2) exposure to airborne toxins, other hazards, or adverse conditions resulting from the September 11, 2001, terrorist attacks is substantially likely to be a significant factor in aggravating, contributing to, or causing the type of cancer for which the responder or survivor seeks treatment coverage.13 Pursuant to 42 CFR 88.12(a), the physician’s determination must be based on: (1) An assessment of the individual’s exposure to airborne toxins, any other hazard, or any other adverse condition resulting from the September 11, 2001, attacks; and (2) the type of symptoms reported and the temporal sequence of those symptoms. As a second statutory requirement, all physician determinations are reviewed by the Administrator and, if found to satisfactorily meet the exposure assessment and symptom requirements, are certified for treatment coverage. Thus, inclusion of a condition on the List of WTC-Related Health Conditions, in and of itself, does not guarantee that a particular individual’s condition will be certified as eligible for treatment. Responders and survivors denied certification have a right to appeal the denial of certification. Early detection of cancer in 9/11exposed populations—either as part of medical monitoring of enrolled WTC responders and survivors or part of ongoing research—is an important adjunct to the WTC Health Program. Screening for the cancers proposed by 13 See § 3312(a)(1), Title XXXIII of the PHS Act; 42 U.S.C. 300mm–22(a)(1). PO 00000 Frm 00020 Fmt 4701 Sfmt 4702 this rulemaking follow U.S. Preventive Services Task Force (USPSTF) Guidelines. There are two types of cancer proposed to be added to the List of WTC-Related Health Conditions for which the USPSTF has a current recommendation for screening. The USPSTF recommends screening for colorectal cancer (cancer of the colon and rectum) using fecal occult blood testing, sigmoidoscopy, or colonoscopy, in adults, beginning at age 50 years and continuing until age 75 years. [USPSTF 2008] The Task Force also recommends breast cancer screening using biennial mammography for women beginning at age 40.14 7. Endnotes American Cancer Society [2012] Cancer Facts & Figures 2012. American Cancer Society, Atlanta, GA. Available at https://www. cancer.org/Research/CancerFactsFigures/ CancerFactsFigures/cancer-facts-figures2012. Cogliano VJ, Baan R, Straif K, Grosse Y, Lauby-Secretan B, El Ghissassi F, Bouvard B, Benbrahim-Tallaa L, Guha N, Freeman C, Galichet L, Wild CP [2011]. Preventable Exposures Associated with Human Cancers. J Natl Cancer Inst 103:1827–1839. COPC (Contaminants of Potential Concern) Committee [2003]. World Trade Center Indoor Environment Assessment: Selecting Contaminants of Potential Concern and Setting Health-Based Benchmarks. https:// www.epa.gov/wtc/reports/ contaminants_of_concern_benchmark_ study.pdf. Accessed April 18, 2011. Bradford Hill A [1965]. The Environment and Disease: Association or Causation? Proceedings of the Royal Society of Medicine (May) 58:295–300. Howard J [2011]. October 5, 2011 Letter from John Howard, MD, Director, National Institute for Occupational Safety and Health (NIOSH) to the WTC Health Program Scientific/Technical Advisory Committee. This letter is included in the docket for this rulemaking. See http:www.regulations.gov and https:// www.cdc.gov/niosh/docket/archive/ docket257.html. IARC (International Agency for Research on Cancer) [1985]. IARC Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans: Vol. 35— Polynuclear Aromatic Compounds, Part 4, Bitumens, Coal-Tars and Derived Products, Shale-Oils and Soots. IARC, Lyon, France. https://monographs.iarc.fr/ENG/ Monographs/vol35/volume35.pdf. Accessed April 9, 2012. IARC (International Agency for Research on Cancer) [2006]. IARC Monographs on the Evaluation of the Carcinogenic Risk of 14 The Department of Health and Human Services, in implementing the Affordable Care Act under the standard it sets out in revised § 2713(a)(5) of the Public Health Service Act, utilizes the 2002 recommendation on breast cancer screening of the USPSTF. Available at https://www. uspreventiveservicestaskforce.org/uspstf/uspsbrca 2002.htm. Accessed June 7, 2012. E:\FR\FM\13JNP2.SGM 13JNP2 erowe on DSK2VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules Chemicals to Humans: Vol. 88— Formaldehyde, 2–Butoxyethanol and 1tert-Butoxypropan-2-ol. IARC, Lyon, France. https://monographs.iarc.fr/ENG/ Monographs/vol88/index.php. Accessed April 9, 2012. IARC (International Agency for Research on Cancer) [2008]. IARC Monographs on the Evaluation of Carcinogenic Risks to Humans: Vol. 97—1,3–Butadiene, Ethylene Oxide and Vinyl Halides (Vinyl Fluoride, Vinyl Chloride and Vinyl Bromide). IARC, Lyon, France. https://monographs.iarc.fr/ ENG/Monographs/vol97/index.php. Accessed April 9, 2012. IARC (International Agency for Research on Cancer) [2012a]. IARC Monographs on the Evaluation of Carcinogenic Risks to Humans: Vol. 100—A Review of Human Carcinogens. Part C: Arsenic, Metals, Fibres, and Dusts. IARC, Lyon, France. https://monographs.iarc.fr/ENG/ Monographs/vol100C/index.php. Accessed April 9, 2012. IARC (International Agency for Research on Cancer) [2012b]. IARC Monographs on the Evaluation of Carcinogenic Risks to Humans: Vol. 100—A Review of Human Carcinogens. Part D: Radiation. IARC, Lyon, France. https://monographs.iarc.fr/ ENG/Monographs/vol100D/index.php. Accessed April 9, 2012. IARC (International Agency for Research on Cancer) [2012c]. IARC Monographs on the Evaluation of Carcinogenic Risks to Humans: Vol. 100—A Review of Human Carcinogens. Part F: Chemical Agents and Related Occupations. IARC, Lyon, France. https://monographs.iarc.fr/ENG/ Monographs/vol100F/index.php. Accessed April 9, 2012. Lagergren J, Bergstrom R, Lingren A, Nyren O [1999]. Symptomatic Gastroesophageal Reflux as a Risk Factor for Esophageal Adenocarcinoma. New Engl J Med 340(11): 825–831. Lioy PJ, Weisel CP, Millette JR, Eisenreich S, Vallero D, Offenberg J, Buckley B, Turpin B, Zhong M, Cohen MD, Prophete C, Yang I, Stiles R, Chee G, et al. [2002]. Characterization of the Dust/Smoke Aerosol that Settled East of the World Trade Center (WTC) in Lower Manhattan after the Collapse of the WTC 11 September 2001. Environ Health Perspect 110(7):703–714. Lorber M, Gibb H, Grant L, Pinto J, Pleil J, Cleverly D [2007]. Assessment of Inhalation Exposures and Potential Health Risks to the General Population that Resulted from the Collapse of the World Trade Center Towers. Risk Anal 27(5):1203–21. Maloney CB, Nadler J, King PT, Schumer CE, Gillibrand KE, Rangel CB, Velazquez NM, Grimm MG, Clarke YD. [2011]. Letter from Congress to John Howard, MD, Director, National Institute for Occupational Safety and Health (NIOSH). WTC Health Program Petition 001. Petition 001 is included in the docket for this rulemaking. See http:www.regulations.gov and https:// www.cdc.gov/niosh/docket/archive/ docket257.html. National Toxicology Program (NTP), Department of Health and Human VerDate Mar<15>2010 15:06 Jun 12, 2012 Jkt 226001 Services. [2012] Request for Public Comment on Nominations and Call for Additional Nominations to the Report on Carcinogens. 77 Fed. Reg. 2728 (January 12, 2012). NIOSH [2011]. First Periodic Review of Scientific and Medical Evidence Related to Cancer for the World Trade Center Health Program. NIOSH Publication No. 2011– 197. https://www.cdc.gov/niosh/docs/2011– 197/pdfs/2011–197.pdf/. Accessed April 18, 2012. NTP (National Toxicology Program) [2011]. 12th Report on Carcinogens. National Toxicology Program, Public Health Service, U.S. Department of Health and Human Services, Research Triangle Park, NC. https://ntp-server.niehs.nih.gov/ ?objectid=72016262–BDB7–CEBA– FA60E922B18C2540. Accessed May 10, 2012. Parekh P, Semkow T, Husain L, Wozniak G [2002]. Tritium in the World Trade Center September 11th, 2001 Terrorist Attack: Its possible sources and fate. Abstr Pap Am Chem Soc 223:026–NUCL. Pleil JD, Vette AF, Johnson BA, Rappaport SM [2004]. Air Levels of Carcinogenic Polycyclic Aromatic Hydrocarbons After the World Trade Center Disaster. Proc Natl Acad Sci USA. 101:11685–11688. Rare Diseases Act of 2002 (Pub. L. 107–208), codified in Title IV, § 404f(c) of the PHS Act (42 U.S.C. § 283h(c)). Young JL, Ward KC, Ries LAG, Chapter 30 in Ries LAG, Young JL, Keel GE, Eisner MP, Lin YD, Horner M–J (editors). SEER Survival Monograph: Cancer Survival Among Adults: U.S. Seer Program, 1988– 2001, Patient and Tumor Characteristics. National Cancer Institute, SEER Program, NIH Pub. No. 07–6215, Bethesda, MD, 2007. STAC (World Trade Center Health Program Scientific/Technical Advisory Committee) [2012]. Letter from Elizabeth Ward, Chair to John Howard, MD, Administrator. This letter is included in the docket for this rulemaking. See http:www.regulations.gov and https://www.cdc.gov/niosh/docket/ archive/docket257.html. Straif K, Baan R, Grosse Y, Secretan B, El Ghissassi F, Bouvard V, Altieri, Benbrahim-Tallaa L, Cogliano V [2007]. Carcinogenicity of Shift-Work, Painting, and Fire-Fighting. Lancet Oncol. Dec 8:1065–1066. United States Preventive Services Task Force (USPSTF) [2008]. Screening for Colorectal Cancer. Available at https:// www.uspreventiveservicestaskforce.org/ uspstf/uspscolo.htm. Accessed May 28, 2012. Wallingford KM, Snyder EM [2001]. Occupational Exposures During the World Trade Center Disaster Response. Toxicol Ind Health 17:247–253. WHO (World Health Organization) [1978]. International Classification of Diseases, Ninth Revision. Geneva: World Health Organization. WHO (World Health Organization) [1997]. International Classification of Diseases, Tenth Revision. Geneva: World Health Organization. Zeig-Owens R, Webber MP, Hall CB, Schwartz T, Jaber N, Weakley J, Rohan TE, PO 00000 Frm 00021 Fmt 4701 Sfmt 4702 35593 Cohen HW, Derman O, Aldrich TK, Kelly K, Prezant DJ [2011]. Early Assessment of Cancer Outcomes in New York City Firefighters After the 9/11 Attacks: An Observational Cohort Study. Lancet. 378(9794):898–905. E. Effects of Rulemaking on Federal Agencies Title II of the James Zadroga 9/11 Health and Compensation Act of 2010 (Pub. L. 111–347) reactivated the September 11, 2001 Victim Compensation Fund (VCF). Administered by the U.S. Department of Justice (DOJ), the VCF provides compensation to any individual or representative of a deceased individual who was physically injured or killed as a result of the September 11, 2001, terrorist attacks or during the debris removal. Eligibility criteria for compensation by the VCF include a list of presumptively covered health conditions, which are physical injuries determined to be WTC-related health conditions by the WTC Health Program. Pursuant to DOJ regulations, the VCF Special Master is required to update the list of presumptively covered conditions when the List of WTC-Related Health Conditions in 42 CFR 88.1 is updated.15 IV. Summary of Proposed Rule The proposed rule would amend the definition of ‘‘List of WTC-Related Health Conditions’’ in 42 CFR 88.1, to include the types of cancer discussed above in section II.D. Table 1 in the regulatory text describes types of cancers included in 42 CFR 88.1 and identifies each by ICD–10 code. Because the ICD–10 modification will not be used by the U.S. healthcare system until October 1, 2014, the corresponding ICD– 9 codes for the included cancer types are also provided in Table 1. The effect of this amendment would be that, for the types of cancers added, an enrolled WTC responder, certifiedeligible survivor, or screening-eligible survivor may seek certification of a physician’s determination that the September 11, 2001, terrorist attacks were substantially likely to be a significant factor in aggravating, contributing to, or causing the individual’s cancer. If the condition is certified by the Administrator, the individual may seek treatment and monitoring of this condition under the WTC Health Program. 15 28 E:\FR\FM\13JNP2.SGM CFR 104.21. 13JNP2 35594 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules V. Regulatory Assessment Requirements erowe on DSK2VPTVN1PROD with PROPOSALS2 A. Executive Order 12866 and Executive Order 13563 Executive Orders 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, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has been determined to be a ‘‘significant regulatory action,’’ under § 3(f) of E.O. 12866. The addition of specific types of cancer proposed to be added to the List of WTC-Related Health Conditions by this rule is estimated to cost the WTC Health Program between $2,124,624 16 and $5,019,182 17 (see Table 9) for the first year (2013). Because a portion of responders and survivors are also covered by private health insurance, employer-provided insurance (such as FDNY), or Medicare or Medicaid, only a portion of the costs, those costs representing the uninsured, are societal costs. All other costs to the WTC Health Program are transfers. After the implementation of provisions of the Patient Protection and Affordable Care Act (Pub. L. 111–148) on January 1, 2014, all of the costs to the WTC Health Program will be transfers. Transfers from FY 2013 through FY 2016 are expected to be between $12,458,535 and $33,308,060 per annum. Accordingly, this rule has been reviewed by the Office of Management and Budget. The proposed rule would not interfere with State, local, and Tribal governments in the exercise of their governmental functions. Cost Estimates The WTC Health Program has, to date, enrolled approximately 55,000 New York City responders and approximately 5,000 survivors, or approximately 60,000 individuals in total. Of that total population, approximately 59,000 individuals were participants in previous WTC medical programs and were ‘grandfathered’ into the WTC Health Program established by Title XXXIII. These grandfathered members were enrolled without having to 16 Based on a population of 60,000 at the U.S. cancer rate and discounted at 7 percent. 17 Based on a population of 110,000 at 21 percent above the U.S. cancer rate and discounted at 3 percent. VerDate Mar<15>2010 15:06 Jun 12, 2012 Jkt 226001 complete a new member application when the WTC Health Program started on July 1, 2011 and are referred to in the WTC Health Program regulations in 42 CFR Part 88 as ‘‘currently identified responders’’ and ‘‘currently identified survivors.’’ In addition to those currently identified WTC responders and survivors already enrolled, the PHS Act 18 sets a numerical limitation on the number of eligible members who can enroll in the WTC Health Program beginning July 1, 2011 at 25,000 new WTC responders and 25,000 new certified-eligible WTC survivors 19 (i.e., the statute restricts new enrollment). Since July 1, 2011, a total of approximately 1,000 new WTC responders and new WTC survivors have enrolled in the WTC Health Program, resulting in only a minor impact on the statutory enrollment limits for new members. For the purpose of calculating a baseline estimate of cancer prevalence only, HHS assumed that this gradual rate of enrollment would continue, and that the currently enrolled population numbers would remain around 55,000 WTC responders and 5,000 WTC survivors. The estimate is further based on the average U.S. cancer prevalence rate, and 7 percent discount rate. As it is not possible to identify an upper bound estimate, HHS has modeled another possible point on the continuum. For the purpose of calculating the impact of an increased rate of cancer on the WTC Health Program, this analysis assumes that the entire statutory cap for new WTC responders (25,000) and WTC survivors (25,000) will be filled. Accordingly, this estimate is based on a population of 80,000 responders (55,000 currently identified + 25,000 new) and 30,000 survivors (5,000 currently identified + 25,000 new). The upper cost estimate also assumes an overall increase in population cancer rates of 21 percent due to 9/11 exposure,20 and costs were discounted at 3 percent. The choice of a 21 percent increase in the risk of cancer of the rate found in the unexposed population is based on findings presented in the only published epidemiologic study of September 11, 2001 exposed populations to date. [ZeigOwens, et al. 2011] Given the challenges 18 PHS Act, Title XXXIII § 3311(a)(4)(A) and § 3321(a)(3)(A). 19 See 42 CFR 88.8(b) for explanation of a certified-eligible survivor. 20 Zeig-Owens R, Webber MP, Hall CB, Schwartz T, Jaber N, Weakley J, Rohan TE, Cohen HW, Derman O, Aldrich TK, Kelly K, Prezant DJ [2011]. Early Assessment of Cancer Outcomes in New York City Firefighters After the 9/11 Attacks: An Observational Cohort Study. Lancet. 378(9794):898– 905. PO 00000 Frm 00022 Fmt 4701 Sfmt 4702 associated with interpreting the ZeigOwens findings,21 we simply characterize 21 percent as a possible outcome rather than asserting the probability that 21 percent is a ‘‘likely’’ outcome. HHS invites public comment on alternative approaches to estimating the costs and benefits described in this rulemaking, considering for example cancer latency. HHS acknowledges that some cancer cases are not likely to have been caused by exposure to 9/11 agents. The certification of individual cancer diagnoses will be conducted on a caseby-case basis, after consideration of the individual responder’s or survivor’s exposure to 9/11 agents and the temporal sequence of symptoms. However, for the purpose of this analysis, HHS has estimated that all diagnosed cancers proposed to be added to the List will be certified for treatment by the WTC Health Program. Finally, because there are no existing data on cancer rates related to exposure to 9/11 agents at either the Pentagon or in Shanksville, Pennsylvania, HHS has used only data from studies of individuals who were responders or survivors in the New York City disaster area. HHS invites comment on this approach. Costs of Cancer Treatment HHS estimated the treatment costs associated with covering the select types of cancer proposed in this rulemaking using the methods described below. In the following discussion, the category of ‘‘Head and Neck’’ includes all cancer cases from nasal cavity, nasopharynx, accessory sinuses, and larynx. The survival rates for all cancers in the ‘‘Head and Neck’’ category were approximated using survival rates for cancer of the larynx. The category described as ‘‘Lung’’ in this discussion includes cancer of the trachea, bronchus and lung, heart, mediastinum and pleura, and other sites in the respiratory system and intrathoracic organs. Treatment costs for all respiratory system cancers including ‘‘mesothelioma’’ were approximated by treatment costs for lung cancer. Costs of treatment for the ‘‘digestive system’’ were approximated using the costs of gastric cancer; costs for cancer of the ‘‘skin’’ were approximated using costs for melanoma of the skin; ‘‘female reproductive organs’’ were 21 As Zeig-Owens et al point out, the time interval since 9/11 is short for cancer outcomes, the recorded excess of cancers is not limited to specific sites, and the biological plausibility of chronic inflammation as a possible mediator between WTCexposure and cancer means that the outcomes remain speculative. E:\FR\FM\13JNP2.SGM 13JNP2 35595 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules approximated using costs for cancer of the ovary; ‘‘urinary system’’ cancer was approximated by costs of urinary bladder cancer; and ‘‘blood and lymphoid tissue’’ cancers were approximated using leukemia and lymphoma. The costs for cancer identified with the ‘‘endocrine system,’’ the ‘‘soft tissue sarcomas,’’ and ‘‘eye/ orbit’’ were approximated using costs for treatment of ‘‘other’’ tumors. The ‘‘other’’ category includes treatments costs from: salivary gland, nasopharynx, tonsil, small intestine, anus, intrahepatic bile duct, gallbladder, other biliary, retroperitoneum, peritoneum, other digestive organs, nose, nasal cavity, middle ear, larynx, pleura, trachea, mediastinum and other respiratory organs, bones and joints, soft tissue, other nonepithelial skin, vagina, vulva, other female genital organs, penis, other male genital organs, ureter, other urinary organs, eye and orbit, thyroid, other endocrine multiple myeloma, and miscellaneous. The WTC Health Program obtained data for the cost of providing medical treatment for each cancer type. The costs of treatment for each type of cancer are described in Table 1. The costs of treatment are divided into three phases: the costs for the first year following diagnosis, the costs of intervening years or continuing treatment after the first year, and the costs of treatment for the last year of life. The first year costs of cancer treatment are higher due to the initial need for aggressive medical (e.g. radiation, chemotherapy) and surgical care. The costs during last year of life are often dominated by increased hospitalization costs.22 Therefore, we used three different treatment phase costs to estimate the costs of treatment to be able to best estimate costs in conjunction with expected incidence and long-term survival for each type of cancer. TABLE 1—AVERAGE COSTS OF TREATMENT, MALE AND FEMALE [2011 $] Initial (12 month) Category Head and Neck .......................................................................................................... Digestive System ....................................................................................................... Respiratory System ................................................................................................... Mesothelium ............................................................................................................... Skin ............................................................................................................................ Female Reproductive Organs .................................................................................... Urinary System .......................................................................................................... Blood & Lymphoid Tissue .......................................................................................... Endocrine System ...................................................................................................... Soft Tissue Sarcomas ............................................................................................... Melanoma .................................................................................................................. Breast ......................................................................................................................... Eye/Orbit .................................................................................................................... Continuing (annual) $28,265 59,551 45,493 45,493 3,938 66,527 16,926 33,312 30,859 30,859 3,938 15,136 30,859 Last year of life (12 mos.) $3,136 2,544 5,026 5,026 1,040 5,023 3,630 5,782 3,791 3,791 1,040 1,550 3,791 $47,730 68,242 65,592 65,592 25,351 64,728 40,905 69,070 58,623 58,623 25,351 37,684 58,623 Source: 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. Journal: J Natl Cancer Inst 100(9):630–41. These cost figures were based on a study of elderly cancer patients from Surveillance, Epidemiology, and End Results (SEER) program maintained by the National Cancer Institute, using Medicare files.23 The average costs of treatment described above are given in 2011 prices adjusted using the Medical Consumer Price Index for all urban consumers.24 Incident Cases of Cancer HHS 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 for the cancer types proposed to be added to the List of WTC-Related Health Conditions under this rulemaking. 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. Gender and age (at the time of exposure) distributions for responders and survivors were assumed to be the same as current enrollees in the WTC Health Program. According to WTC Health Program data, males comprise 88 percent of the current responder enrollees and 50 percent of survivor enrollees. The age distribution for current enrollees by gender and responder/survivor status is presented in Table 2. TABLE 2—PERCENTILES OF CURRENT AGE (ON APRIL 11, 2012) FOR CURRENT ENROLLEES IN THE WTC HEALTH PROGRAM BY GENDER AND RESPONDER/SURVIVOR STATUS Group Age percentile (years) erowe on DSK2VPTVN1PROD with PROPOSALS2 Min Male responders .............................................................. Female responders .......................................................... 22 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. Journal: J Natl Cancer Inst 100(9):630–41. VerDate Mar<15>2010 15:06 Jun 12, 2012 Jkt 226001 1 28 28 10 32 30 30 39 38 50 44 44 23 Surveillance, Epidemiology, and End Results (SEER) Program (www.seer.cancer.gov) Research Data (1973–2006), National Cancer Institute, DCCPS, Surveillance Research Program, Surveillance Systems Branch, released April 2009, based on the November 2008 submission. PO 00000 Frm 00023 Fmt 4701 Sfmt 4702 70 49 49 90 54 54 99 62 62 Max 74 76 92 92 24 Bureau of Labor Statistics. Consumer Price Index https://research.stlouisfed.org/fred2/series/ CPIMEDSL/downloaddata?cid=32419. Accessed April, 23, 2012. E:\FR\FM\13JNP2.SGM 13JNP2 35596 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules TABLE 2—PERCENTILES OF CURRENT AGE (ON APRIL 11, 2012) FOR CURRENT ENROLLEES IN THE WTC HEALTH PROGRAM BY GENDER AND RESPONDER/SURVIVOR STATUS—Continued Group Age percentile (years) Min Male survivors .................................................................. Female survivors .............................................................. HHS assumed race and ethnic origin distributions for responders and survivors according to distributions in the WTC Health Registry cohort: 25 57 percent non-Hispanic white, 15 percent non-Hispanic black, 21 percent Hispanic, and 8 percent other race/ ethnicity for responders and 50 percent non-Hispanic white, 17 percent nonHispanic black, 15 percent Hispanic, and 18 percent other race/ethnicity for survivors. 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 (since rates are currently available through 2008, the rate from 2008 was applied to 2009 and later).26 A life-table analysis program, LTAS.NET, was used to estimate the expected number of 1 12 12 10 23 21 30 35 38 50 46 49 70 52 54 incident cancers for cancer types proposed to be added.27 HHS calculated cancer incidence rates using data through 2006 from the Surveillance Epidemiology and End Results (SEER) Program, and estimated rates for 2007– 2016.28 The Program applied the resulting gender, race, age, and yearspecific cancer incidence rates to the estimated person-years at risk to estimate the expected number of cancer cases for each cancer type starting from year 2002, the first full year following the September 11, 2001, terrorist attacks, to 2016, the last year for which this Program is authorized. 90 58 60 99 67 68 Max 81 84 99 95 table provides for each year from 2002 through 2016, the number of new cases occurring in that year (incidence), the number of individuals who died from their cancer in that year, and the number of persons surviving up to 15 years beyond their first diagnosis with one table for each type of cancer (prevalence).30 For example, in 2002 there are 23.47 projected new lung cancer cases, which would be listed as incident cases for that year. The survival rate for lung cancer in the first year of diagnosis is 40.6 percent.31 Therefore the number of deceased persons in 2002 would be 18.78 × (1–0.406) = 11.15. For the lung cancer prevalence table, in year 2003, the number of incident cases would be 20.88 cases. In addition to 20.88 newly diagnosed cases in 2003, there would be the one-year survivors from 2002 which would be 18.78—11.15 (or 18.78 × 0.406) = 7.62 cases. This computation process can be repeated for each year through year 2016. A portion of the lung cancer prevalence table is provided in Table 3 as an example. Prevalence tables were created for each type of covered cancer and the results are summarized in Tables 5, and 7. This analysis considers cancers diagnosed in 2002 through 2016. Prevalence of Cancer To determine the potential number of persons in the responder and survivor populations with cancer, HHS used the number of incident cases described above for each year starting with 2002, and estimated the prevalence of cancer using survival rate statistics for each incident cancer group through 2016.29 Using the incident cases and survival rate statistics for each cancer type, HHS has estimated the prevalence (number of persons living with cancer) of cases during the 15 year period (2002–2016) since September 11, 2001. The resulting TABLE 3—EXAMPLE FROM PREVALENCE TABLE FOR LUNG CANCER [Based on 80,000 responders] Years since exposure to 9/11 agents Years covered by WTC Health Program Year 2002 erowe on DSK2VPTVN1PROD with PROPOSALS2 1 2 3 4 5 6 7 8 9 (incidence) ............................................ ............................................................... ............................................................... ............................................................... ............................................................... ............................................................... ............................................................... ............................................................... ............................................................... 2003 18.78 .................... .................... .................... .................... .................... .................... .................... .................... 20.88 7.62 .................... .................... .................... .................... .................... .................... .................... 25 Jordan HT, Brackbill RM, Cone JE, Debchoudhury I, Farfel MR, Greene CM, Hadler JL, Kennedy J, Li J, Liff J, Stayner L, Stellman SD. Mortality Among Survivors of the Sept 11, 2001, Word Trade Center Disaster: Results from the World Trade Center Health Registry Cohort. Lancet 2011;378:879–887. 26 Centers for Disease Control and Prevention, National Center for Health Statistics. Compressed Mortality File 1999–2008. CDC WONDER Online Database, compiled from Compressed Mortality File VerDate Mar<15>2010 15:06 Jun 12, 2012 Jkt 226001 2012 2013 46.53 17.00 9.25 6.42 4.95 4.01 3.28 2.71 2.55 51.22 18.89 10.18 7.08 5.46 4.45 3.67 3.03 2.49 1999–2008 Series 20 No. 2N, 2011. Accessed at https://wonder.cdc.gov/cmf-icd10.html 15 February 2012. 27 Schubauer-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. American Journal of Industrial Medicine 54:915–924. PO 00000 Frm 00024 Fmt 4701 Sfmt 4702 2014 56.10 20.79 11.30 7.79 6.02 4.90 4.07 3.38 2.78 2015 60.69 22.78 12.45 8.66 6.62 5.40 4.49 3.76 3.10 2016 66.03 24.64 13.63 9.53 7.35 5.94 4.94 4.14 3.45 28 National Cancer Institute, Surveillance Epidemiology and End Results (SEER). https:// seer.cancer.gov/. Accessed May 27, 2012. 29 National Cancer Institute, Surveillance Epidemiology and End Results (SEER). https:// seer.cancer.gov/. Accessed May 27, 2012. 30 The 15-year survival limit is imposed based on the analytic time horizon. 31 National Cancer Institute, Surveillance Epidemiology and End Results (SEER). https:// seer.cancer.gov/. Accessed May 27, 2012. E:\FR\FM\13JNP2.SGM 13JNP2 35597 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules TABLE 3—EXAMPLE FROM PREVALENCE TABLE FOR LUNG CANCER—Continued [Based on 80,000 responders] Years since exposure to 9/11 agents Years covered by WTC Health Program Year 2002 10 ............................................................. 11 ............................................................. 12 ............................................................. 13 ............................................................. 14 ............................................................. 15 ............................................................. Live cases from previous years ............... Prevalence ............................................... Last year of life ........................................ 2003 2012 2013 2014 2015 .................... .................... .................... .................... .................... .................... .................... 18.78 11.15 .................... .................... .................... .................... .................... .................... .................... 28.50 15.46 2.15 1.78 .................... .................... .................... .................... 54.11 100.64 39.38 2.38 1.98 1.66 .................... .................... .................... 61.26 112.48 43.54 2.33 2.20 1.84 1.52 .................... .................... 68.94 125.03 47.87 2.60 2.14 2.04 1.69 1.42 .................... 77.16 137.85 52.10 Cost Computation To compute the costs for each type of cancer, HHS assumes that all of the individuals who are diagnosed with a cancer type will be certified by the WTC Health Program for treatment and monitoring services. The treatment costs for the first year of treatment (Table 1, 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 1 were applied to the number of prevalent cases who had survived their cancers beyond their year of diagnosis, for each year of survival (Year 2–15). Using this procedure, a cost table is constructed for each year covered by the WTC Health Program. Table 4 provides 2016 2.90 2.40 1.99 1.88 1.58 1.35 85.74 151.78 56.79 an illustrative example for lung cancer. The row for Year 1 is the cost of incident cases for that year. Rows 2–15 show the cost from continuing care for persons surviving n-years beyond the year of diagnosis. Finally, the cost of last year of life treatment is computed by multiplying the cost for last year of life from Table 1 by the number of persons dying in that year from that type of cancer. TABLE 4—COST PER 80,000 RESPONDERS FOR LUNG CANCER, 2011$ Years covered by the WTC Health Program Year 2014 2015 1 ............................................................................................... 2 ............................................................................................... 3 ............................................................................................... 4 ............................................................................................... 5 ............................................................................................... 6 ............................................................................................... 7 ............................................................................................... 8 ............................................................................................... 9 ............................................................................................... 10 ............................................................................................. 11 ............................................................................................. 12 ............................................................................................. 13 ............................................................................................. 14 ............................................................................................. 15 ............................................................................................. Prevalent care .......................................................................... Last year of life care ................................................................ $914,986 91,825 49,469 34,408 26,537 21,624 17,840 14,727 12,080 11,608 9,642 8,032 .............................. .............................. .............................. 1,212,778 2,762,609 $1,002,168 101,077 54,959 37,865 29,228 23,850 19,797 16,468 13,500 11,311 10,706 8,932 7,393 .............................. .............................. 1,337,254 3,037,261 $1,084,205 110,708 60,497 42,068 32,165 26,268 21,834 18,274 15,096 12,641 10,433 9,917 8,221 6,936 .............................. 1,459,263 3,305,416 $1,179,677 119,770 66,261 46,306 35,735 28,908 24,048 20,155 16,751 14,135 11,659 9,664 9,128 7,714 6,571 1,589,911 3,603,198 Total .................................................................................. erowe on DSK2VPTVN1PROD with PROPOSALS2 2013 3,975,387 4,374,515 4,764,679 5,193,109 The sum of the annual costs for the years 2013 through 2016 represents the estimated treatment costs to the WTC Health Program for coverage of lung cancer for 80,000 responders. The cost projections in Table 4 are based on an assumed responder population size of 80,000. The same process described above was applied to the survivor cohort. Based on the incidence rate expected from the survivor cohort, prevalence tables were constructed for each covered type of cancer. VerDate Mar<15>2010 15:06 Jun 12, 2012 Jkt 226001 The estimated treatment costs for responders and survivors were recomputed under two assumptions: (1) Assuming the rate of cancer in the WTC Health Program is equal to the rate of cancer observed in the general population; and (2) assuming the rate of cancer exceeds the general population rate by 21 percent due to their exposures in the New York City disaster area.32 HHS is not aware of any other 32 Zeig-Owens R, Webber MP, Hall CB, Schwartz T, Jaber N, Weakley J, Rohan TE, Cohen HW, PO 00000 Frm 00025 Fmt 4701 Sfmt 4702 2016 estimates of excess cancer rates in the 9/11-exposed population in the peerreviewed literature. Derman O, Aldrich TK, Kelly K, Prezant DJ [2011]. Early Assessment of Cancer Outcomes in New York City Firefighters After the 9/11 Attacks: An Observational Cohort Study. Lancet. 378(9794):898– 905. Limitations of the Zeig-Owens study include: limited information on specific exposures experienced by firefighters; short time for follow-up of cancer outcomes; speculation about the biological plausibility of chronic inflammation as a possible mediator between WTC-exposure and cancer outcomes; and potential unmeasured confounders. E:\FR\FM\13JNP2.SGM 13JNP2 35598 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules A summary of the estimated prevalence at the U.S. population average for the assumed population of 55,000 responders and 5,000 survivors is provided in Table 5. A summary of the estimated treatment costs to the WTC Health Program is provided in Table 6. A summary of the estimated prevalence using cancer rates 21 percent over the U.S. population average for the increased rate of 80,000 responders and 30,000 survivors is given in Table 7. A summary of the estimated treatment costs to the WTC Health Program is provided in Table 8. TABLE 5—ESTIMATED PREVALENCE BY YEAR AND CANCER TYPE BASED ON 55,000 AND 5,000 RESPONDER AND SURVIVOR POPULATION, RESPECTIVELY AND ASSUMING CANCER RATES AT U.S. POPULATION AVERAGE Prevalence (incident + live cases) Cancer type 2013 2014 2015 2016 Based on 55,000 responder population Head & Neck ........................................................................... Digestive System ..................................................................... Respiratory System ................................................................. Mesothelioma ........................................................................... Skin .......................................................................................... Female Reproductive Organs .................................................. Urinary System ........................................................................ Blood & Lymphoid Tissue ........................................................ Endocrine System .................................................................... Soft Tissue Sarcomas ............................................................. Melanoma ................................................................................ Breast ....................................................................................... Eye/Orbit .................................................................................. 89.41 136.54 77.91 1.02 11.04 5.14 108.78 119.72 53.50 11.02 134.33 102.30 3.89 99.20 150.69 86.61 1.12 12.22 5.64 121.39 130.72 58.75 11.86 149.37 113.46 4.29 109.35 165.19 95.50 1.23 13.43 6.14 134.69 141.97 64.05 12.67 165.05 124.91 4.71 119.83 180.38 105.16 1.35 14.71 6.65 148.90 153.71 69.40 13.47 181.42 136.66 5.14 Total .................................................................................. 854.59 945.32 1,038.88 1,136.78 Based on 5,000 survivor population Head & Neck ........................................................................... Digestive System ..................................................................... Respiratory System ................................................................. Mesothelioma ........................................................................... Skin .......................................................................................... Female Reproductive Organs .................................................. Urinary System ........................................................................ Blood & Lymphoid Tissue ........................................................ Endocrine System .................................................................... Soft Tissue Sarcomas ............................................................. Melanoma ................................................................................ Breast ....................................................................................... Eye/Orbit .................................................................................. 7.78 15.48 10.28 0.10 1.13 2.58 10.47 12.48 4.29 0.96 12.21 9.30 0.35 7.78 15.48 10.28 0.10 1.13 2.58 10.47 12.48 4.29 0.96 13.58 10.31 0.39 7.78 15.48 10.28 0.10 1.13 2.58 10.47 12.48 4.29 0.96 15.00 11.36 0.43 7.78 15.48 10.28 0.10 1.13 2.58 10.47 12.48 4.29 0.96 16.49 12.42 0.47 Total .................................................................................. 87.41 89.83 92.33 94.93 TABLE 6—ESTIMATED TREATMENT COSTS BY YEAR AND CANCER TYPE BASED ON 55,000 AND 5,000 RESPONDER AND SURVIVOR POPULATION, RESPECTIVELY AND ASSUMING CANCER RATES AT U.S. POPULATION AVERAGE [2011 $] Cancer type 2013 2014 2015 2016 2013–2016 erowe on DSK2VPTVN1PROD with PROPOSALS2 Based on 55,000 responder population Head & Neck ......................................... Digestive System ................................... Respiratory System ................................ Mesothelioma ......................................... Skin ........................................................ Female Reproductive Organs ................ Urinary System ...................................... Blood & Lymphoid Tissue ...................... Endocrine System .................................. Soft Tissue Sarcomas ............................ Melanoma .............................................. Breast ..................................................... Eye/Orbit ................................................ $925,673 4,181,699 2,832,704 49,088 18,078 121,957 1,278,299 2,224,916 362,248 148,358 229,538 420,290 36,018 $1,007,744 4,525,672 3,117,317 54,012 20,075 130,292 1,398,867 2,391,015 385,533 158,024 249,805 453,613 39,242 $1,089,966 4,856,402 3,395,504 58,869 21,834 137,643 1,521,993 2,551,304 408,544 167,208 270,744 485,454 42,470 $1,164,226 5,191,940 3,701,062 64,417 23,072 144,194 1,642,997 2,697,317 419,353 175,680 284,528 510,289 45,255 $4,187,609 18,755,713 13,046,587 226,387 83,059 534,086 5,842,157 9,864,552 1,575,678 649,270 1,034,615 1,869,646 162,985 Total ................................................ 12,828,867 13,931,212 15,007,935 16,064,330 57,832,344 VerDate Mar<15>2010 15:06 Jun 12, 2012 Jkt 226001 PO 00000 Frm 00026 Fmt 4701 Sfmt 4702 E:\FR\FM\13JNP2.SGM 13JNP2 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules 35599 TABLE 6—ESTIMATED TREATMENT COSTS BY YEAR AND CANCER TYPE BASED ON 55,000 AND 5,000 RESPONDER AND SURVIVOR POPULATION, RESPECTIVELY AND ASSUMING CANCER RATES AT U.S. POPULATION AVERAGE—Continued [2011 $] Cancer type 2013 2014 2015 2016 2013–2016 Based on 5,000 survivor population Head & Neck ......................................... Digestive System ................................... Respiratory System ................................ Mesothelioma ......................................... Skin ........................................................ Female Reproductive Organs ................ Urinary System ...................................... Blood & Lymphoid Tissue ...................... Endocrine System .................................. Soft Tissue Sarcomas ............................ Melanoma .............................................. Breast ..................................................... Eye/Orbit ................................................ 77,325 471,917 362,274 4,625 1,843 58,454 119,698 229,578 60,893 14,017 30,943 230,196 3,434 82,580 502,369 389,675 4,974 2,034 61,173 128,808 245,051 62,633 14,748 32,541 241,382 3,642 87,736 531,352 416,326 5,291 2,196 63,740 137,954 259,869 63,909 15,415 33,962 251,227 3,832 92,044 559,893 444,551 5,659 2,300 65,729 146,467 272,842 64,476 15,960 35,142 258,804 3,994 339,685 2,065,532 1,612,827 20,549 8,372 249,097 532,927 1,007,340 251,910 60,140 132,588 981,609 14,903 Total ................................................ 1,665,197 1,771,611 1,872,809 1,967,862 7,277,478 Total Head & Neck ......................................... Digestive System ................................... Respiratory System ................................ Mesothelioma ......................................... Skin ........................................................ Female Reproductive Organs ................ Urinary System ...................................... Blood & Lymphoid Tissue ...................... Endocrine System .................................. Soft Tissue Sarcomas ............................ Melanoma .............................................. Breast ..................................................... Eye/Orbit ................................................ 1,002,998 4,653,616 3,194,979 53,713 19,921 180,411 1,397,997 2,454,494 423,141 162,376 260,481 650,486 39,452 1,090,324 5,028,041 3,506,992 58,987 22,109 191,466 1,527,675 2,636,067 448,166 172,772 282,346 694,995 42,885 1,177,702 5,387,754 3,811,830 64,160 24,030 201,383 1,659,948 2,811,173 472,452 182,622 304,706 736,681 46,302 1,256,270 5,751,833 4,145,613 70,076 25,371 209,923 1,789,465 2,970,159 483,829 191,640 319,670 769,093 49,250 4,527,294 20,821,244 14,659,414 246,936 91,431 783,183 6,375,084 10,871,892 1,827,588 709,410 1,167,203 2,851,255 177,888 Total ................................................ 14,494,064 15,702,823 16,880,744 18,032,192 65,109,823 TABLE 7—ESTIMATED PREVALENCE BY YEAR AND CANCER TYPE BASED ON 80,000 AND 30,000 RESPONDER AND SURVIVOR POPULATION, RESPECTIVELY AND ASSUMING INCIDENCE OF CANCER IS 21% HIGHER THAN THE U.S. POPULATION DUE TO 9/11 EXPOSURE Prevalence (incident + live cases) Cancer type 2013 2014 2015 2016 Based on 80,000 responder population erowe on DSK2VPTVN1PROD with PROPOSALS2 Head & Neck ........................................................................... Digestive System ..................................................................... Respiratory System ................................................................. Mesothelioma ........................................................................... Skin .......................................................................................... Female Reproductive Organs .................................................. Urinary System ........................................................................ Blood & Lymphoid Tissue ........................................................ Endocrine System .................................................................... Soft Tissue Sarcomas ............................................................. Melanoma ................................................................................ Breast ....................................................................................... Eye/Orbit .................................................................................. 157.36 240.31 137.12 1.79 19.43 9.05 191.45 210.70 94.16 19.40 236.42 180.05 6.85 174.59 265.21 152.43 1.98 21.50 9.92 213.66 230.07 103.40 20.87 262.90 199.69 7.56 192.45 290.74 168.07 2.16 23.64 10.81 237.05 249.86 112.73 22.29 290.50 219.84 8.29 210.91 317.47 185.08 2.38 25.89 11.71 262.06 270.52 122.15 23.70 319.30 240.52 9.05 Total .................................................................................. 1,504.09 1,663.77 1,828.43 2,000.74 56.51 112.39 74.61 0.70 8.21 56.51 112.39 74.61 0.70 8.21 56.51 112.39 74.61 0.70 8.21 56.51 112.39 74.61 0.70 8.21 Sfmt 4702 E:\FR\FM\13JNP2.SGM Based on 30,000 survivor population Head & Neck ........................................................................... Digestive System ..................................................................... Respiratory System ................................................................. Mesothelioma ........................................................................... Skin .......................................................................................... VerDate Mar<15>2010 15:06 Jun 12, 2012 Jkt 226001 PO 00000 Frm 00027 Fmt 4701 13JNP2 35600 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules TABLE 7—ESTIMATED PREVALENCE BY YEAR AND CANCER TYPE BASED ON 80,000 AND 30,000 RESPONDER AND SURVIVOR POPULATION, RESPECTIVELY AND ASSUMING INCIDENCE OF CANCER IS 21% HIGHER THAN THE U.S. POPULATION DUE TO 9/11 EXPOSURE—Continued Prevalence (incident + live cases) Cancer type 2013 2014 2015 2016 Female Reproductive Organs .................................................. Urinary System ........................................................................ Blood & Lymphoid Tissue ........................................................ Endocrine System .................................................................... Soft Tissue Sarcomas ............................................................. Melanoma ................................................................................ Breast ....................................................................................... Eye/Orbit .................................................................................. 18.73 76.04 90.61 31.11 6.94 88.66 67.52 2.57 18.73 76.04 90.61 31.11 6.94 98.59 74.88 2.83 18.73 76.04 90.61 31.11 6.94 108.94 82.44 3.11 18.73 76.04 90.61 31.11 6.94 119.74 90.20 3.39 Total .................................................................................. 634.60 652.16 670.34 689.18 TABLE 8—ESTIMATED TREATMENT COSTS BY YEAR AND CANCER TYPE BASED ON 80,000 AND 30,000 RESPONDER AND SURVIVOR POPULATION, RESPECTIVELY AND ASSUMING INCIDENCE OF CANCER IS 21% HIGHER THAN THE U.S. POPULATION DUE TO 9/11 EXPOSURE [2011 $] Cancer type 2013 2014 2015 2016 2013–2016 Based on 80,000 responder population Head & Neck ......................................... Digestive System ................................... Respiratory System ................................ Mesothelioma ......................................... Skin ........................................................ Female Reproductive Organs ................ Urinary System ...................................... Blood & Lymphoid Tissue ...................... Endocrine System .................................. Soft Tissue Sarcomas ............................ Melanoma .............................................. Breast ..................................................... Eye/Orbit ................................................ $1,656,113 7,481,440 5,067,965 87,823 32,344 218,192 2,286,993 3,980,577 648,095 265,426 410,664 751,937 64,439 $1,802,945 8,096,839 5,577,164 96,633 35,916 233,104 2,502,701 4,277,744 689,754 282,719 446,924 811,554 70,208 $1,950,049 8,688,544 6,074,865 105,323 39,063 246,256 2,722,984 4,564,514 730,922 299,150 484,385 868,522 75,983 $2,082,906 9,288,852 6,621,536 115,248 41,278 257,976 2,939,472 4,825,745 750,261 314,308 509,047 912,953 80,965 $7,492,013 33,555,675 23,341,531 405,027 148,600 955,528 10,452,150 17,648,581 2,819,031 1,161,603 1,851,021 3,344,966 291,595 Total ................................................ 22,952,009 24,924,205 26,850,560 28,740,547 44,654,652 Based on 30,000 survivor population Head & Neck ......................................... Digestive System ................................... Respiratory System ................................ Mesothelioma ......................................... Skin ........................................................ Female Reproductive Organs ................ Urinary System ...................................... Blood & Lymphoid Tissue ...................... Endocrine System .................................. Soft Tissue Sarcomas ............................ Melanoma .............................................. Breast ..................................................... Eye/Orbit ................................................ 467,817 2,855,098 2,191,761 27,979 11,149 353,646 724,172 1,388,944 368,403 84,805 187,204 1,392,687 20,776 499,610 3,039,331 2,357,535 30,096 12,304 370,100 779,285 1,482,561 378,927 89,226 196,873 1,460,361 22,037 530,802 3,214,682 2,518,774 32,010 13,285 385,629 834,625 1,572,207 386,647 93,258 205,471 1,519,924 23,182 556,869 3,387,354 2,689,533 34,239 13,912 397,662 886,127 1,650,695 390,079 96,557 212,608 1,565,763 24,166 2,055,097 12,496,466 9,757,602 124,324 50,650 1,507,036 3,224,209 6,094,408 1,524,055 363,846 802,156 5,938,735 90,160 Total ................................................ 4,912,377 5,256,038 5,588,087 5,914,152 21,670,654 2,480,851 11,903,227 8,593,639 137,333 52,348 631,884 3,557,609 6,136,721 1,117,568 392,408 689,857 2,639,775 12,676,206 9,311,069 149,487 55,190 655,638 3,825,599 6,476,440 1,140,340 410,864 721,654 9,547,110 46,052,141 33,099,133 529,350 199,251 2,462,564 13,676,358 23,742,988 4,343,086 1,525,449 2,653,177 erowe on DSK2VPTVN1PROD with PROPOSALS2 Total Head & Neck ......................................... Digestive System ................................... Respiratory System ................................ Mesothelioma ......................................... Skin ........................................................ Female Reproductive Organs ................ Urinary System ...................................... Blood & Lymphoid Tissue ...................... Endocrine System .................................. Soft Tissue Sarcomas ............................ Melanoma .............................................. VerDate Mar<15>2010 15:06 Jun 12, 2012 Jkt 226001 2,123,930 10,336,538 7,259,726 115,803 43,493 571,838 3,011,165 5,369,522 1,016,497 350,231 597,868 PO 00000 Frm 00028 2,302,555 11,136,171 7,934,699 126,729 48,220 603,204 3,281,986 5,760,305 1,068,681 371,945 643,798 Fmt 4701 Sfmt 4702 E:\FR\FM\13JNP2.SGM 13JNP2 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules 35601 TABLE 8—ESTIMATED TREATMENT COSTS BY YEAR AND CANCER TYPE BASED ON 80,000 AND 30,000 RESPONDER AND SURVIVOR POPULATION, RESPECTIVELY AND ASSUMING INCIDENCE OF CANCER IS 21% HIGHER THAN THE U.S. POPULATION DUE TO 9/11 EXPOSURE—Continued [2011 $] Cancer type 2013 2014 2015 2016 2013–2016 Breast ..................................................... Eye/Orbit ................................................ 2,144,624 85,215 2,271,916 92,244 2,388,445 99,165 2,478,716 105,132 9,283,702 381,756 Total ................................................ 33,026,449 35,642,452 38,181,054 40,646,111 147,496,066 Because HHS lacks data to account for either recoupment by health insurance or workers’ compensation insurance or reduction by Medicare/Medicaid payments, the estimates offered here are reflective of estimated WTC Health Program costs only. This analysis offers an assumption about the number of individuals who might enroll in the WTC Health Program, and estimates the impact of 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 diagnoses of cancers that are WTC-related health conditions that might result from this action. Those costs were addressed in the interim final rule that established regulations for the WTC Health Program (76 FR 38914, July 1, 2011). Costs and transfers of screening have been added to the summary estimates. The screening proposed by this rulemaking follows U.S. Preventive Services Task Force (USPSTF) guidelines. The USPSTF recommends screening for colorectal cancer (cancer of the colon and rectum) using fecal occult blood testing (FOBT), sigmoidoscopy, or colonoscopy, in adults, beginning at age 50 years and continuing until age 75 years.33 The costs and transfers include the costs of one FOBT for all Program enrollees who are over the age of 50 in 2013, and for those who will reach 50 years of age in 2014 through 2016. In the general population, HHS expects there to be 9 percent positive tests. In a previous study 34 of those with positive tests who were outside the study university system, 44 percent had a colonoscopy, 42 percent had flexible sigmoidoscopy, 11 percent had repeat FOBT, and 3 percent were told by their physician that no further examination was necessary. HHS applied these rates to the population and assigned costs for each test assuming FOBT cost was $7.60, sigmoidoscopy was $238, and a colonoscopy was $674.35 The USPSTF recommends breast cancer screening using biennial mammography for women beginning at age 40. HHS assumed that the population of responders was 12 percent female and the population of survivors was 50 percent female. Based on age distribution information available, HHS estimated the number of women eligible for screening between 2013 and 2016. For those screened in 2013 HHS predicted repeat screening in 2015 and for those screened in 2014 HHS predicted repeat screening in 2016. The cost of a mammogram was estimated at $139.32 based on FECA rates for mammography.36 Some responders and survivors enrolled or expected to enroll in the WTC Health Program already have or have access to medical insurance coverage by private health insurance, employer-provided insurance, Medicare, or Medicaid. Therefore, costs to the WTC Health Program can be divided between societal costs and transfer payments. To describe these societal costs and transfers, the following assumptions were used. For the period of coverage between January 1, 2013 and December 31, 2013, HHS has assumed that 16.3 percent of the survivor population will be uninsured, or based on grandfathered enrollment of responders, 16,925 are covered by the FDNY health plan, while 39,482 are listed as general responders and include construction workers, contractors, and others. For this analysis, HHS assumed that the nonFDNY general responders and all future responder-enrollees are uninsured at the same 16.3 percent rate that HHS applied to the survivor population, based on those without insurance coverage in the general U.S. population.37 Ward et al.38 found that access to health care services, quality of care received, stage of disease at diagnosis, and survival outcomes for cancer patients varied according to socioeconomic status and demographic characteristics. Additionally, after the implementation of provisions of the Patient Protection and Affordable Care Act (Pub. L. 111–148) on January 1, 2014, all of the enrollees and future enrollees can be assumed to have or have access to medical insurance coverage other than through the WTC Health Program. Therefore, all treatment costs to be paid by the WTC Health Program from 2014 through 2016 are considered transfers. Table 9 describes the allocation of WTC Health Program costs between societal costs and transfer payments based on 55,000 responders and 5,000 survivors. Table 10 describes the allocation of WTC Health Program costs between societal costs and transfer payments based on 80,000 responders and 30,000 survivors. 33 United States Preventive Services Task Force (USPSTF) [2008]. Screening for Colorectal Cancer. Available at https:// www.uspreventiveservicestaskforce.org/uspstf/ uspscolo.htm. Accessed May 28, 2012. 34 Mandel JS, et. al, Reducing Mortality From Colorectal Cancer by Screening for Fecal Occult Blood, NEJM 328(19): 1365–1371 (1993). 35 Subramanian S, et. al. When Budgets Are Tight, There Are Better Options Than Colonoscopies For Colorectal Cancer Screening. Health Affairs, September 2010, 29:9, 1734–1740. FECA Rates for FOBT, sigmoidoscopy and colonoscopy at non-facility rates: codes 82270, 45330, and 45378 respectively. 36 FECA rates for Mammography for New York; FECA code 77057. 37 U.S. Census Bureau [2011]. Current Population Survey. https://www.census.gov/cps/data/. Accessed May 26, 2012. 38 Ward E, Halpern M, Schrag N, Cokkinides V, DeSantis C, Bandi P, Siegel R, Stewart A, Jemal A [2008]. Association of Insurance with Cancer Care Utilization and Outcomes. CA Cancer J Clin 58:9– 31. erowe on DSK2VPTVN1PROD with PROPOSALS2 Summary of Costs and Transfers VerDate Mar<15>2010 15:06 Jun 12, 2012 Jkt 226001 PO 00000 Frm 00029 Fmt 4701 Sfmt 4702 E:\FR\FM\13JNP2.SGM 13JNP2 35602 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules TABLE 9—BREAKDOWN OF ESTIMATED ANNUAL WTC HEALTH PROGRAM COSTS AND TRANSFERS, 80,000 & 55,000 RESPONDERS AND 30,000 AND 5,000 SURVIVORS, 2013–2016, 2011$ Societal costs for 2013, 2011$ Based on the 16.3 percent of general responders and survivors who are expected to be uninsured Annualized transfers for 2013–2016, 2011$ Discounted at 7 percent Cancer rate Discounted at 3 percent Cancer rate 55,000 Responders ................................................................. 5,000 Survivors ........................................................................ Colorectal and Breast Screening ............................................. U.S. Average $1,648,706 271,427 204,491 U.S. + 21% .............................. .............................. .............................. U.S. Average $10,172,308 1,572,907 713,321 U.S. + 21% .............................. .............................. .............................. 60,000 Total ............................................................................. 2,124,624 .............................. 12,458,535 .............................. 80,000 Responders ................................................................. 30,000 Survivors ...................................................................... Colorectal and Breast Screening ............................................. .............................. .............................. .............................. $2,631,100 1,970,560 417,521 .............................. .............................. .............................. $19,912,464 12,124,118 1,271,478 110,000 Total ........................................................................... .............................. 5,019,182 .............................. 33,308,060 erowe on DSK2VPTVN1PROD with PROPOSALS2 Examination of Benefits (Health Impact) This section describes qualitatively the potential benefits of the proposed rule in terms of the expected improvements in the health and healthrelated quality of life of potential cancer patients treated through the WTC Health Program, compared to no Program. The assessment of the health benefits for cancer patients uses the number of expected cancer cases that was estimated in the cost analysis section. HHS does not have information on the health of the population that may have been exposed to 9/11 agents and is not currently enrolled in the WTC Health Program. In addition, HHS has only limited information about health insurance and health care services for cancers caused by exposure to 9/11 agents 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, HHS assumes that broad trends on demographics and access to health insurance reported by the U.S. Census Bureau and health care services for cancer similar to those reported by Ward would apply to the population of general responders (those individuals who are not members of the FDNY and who meet the eligibility criteria in 42 CFR Part 88 for WTC responders) and survivors both within and outside the Program. For the purposes of this analysis, HHS assumes that access to health insurance and health care services for FDNY responders within and outside the Program would be equivalent because this population is overwhelmingly VerDate Mar<15>2010 15:06 Jun 12, 2012 Jkt 226001 covered by employer-based health insurance. Although HHS cannot quantify the benefits associated with the WTC Health Program, enrollees with cancer are expected to experience a higher quality of care than they would in the absence of the Program. Mortality and morbidity improvements for cancer patients expected to enroll in the WTC Health Program are anticipated because barriers may exist to access and delivery of quality health care services for cancer patients in the absence of the services provided by the WTC Health Program. HHS anticipates benefits to cancer patients treated through the WTC Health Program, who may otherwise not have access to health care services (16.3 percent of general responders and survivors who are expected to be uninsured), to accrue in 2013. Starting in 2014, continued implementation of the Affordable Care Act will result in increased access to health insurance and health care services will improve for the general responder and survivor population that currently is uninsured. HHS is requesting public comment on issues relating to access to care, quality of care, and the potential benefits associated with the WTC Health Program. Limitations The analysis presented here was limited by the dearth of verifiable data on the cancer status of responders and survivors who have yet to apply for enrollment in the WTC Health Program. Because of the limited data, HHS was not able to estimate benefits in terms of averted healthcare costs. Nor was HHS able to estimate administrative costs, or indirect costs, such as averted PO 00000 Frm 00030 Fmt 4701 Sfmt 4702 absenteeism, short and long-term disability, and productivity losses averted due to premature mortality. Regulatory Alternatives As discussed in section III.D.2., above, the Administrator considered alternative approaches to the methods set forth in this rulemaking. One alternative would involve a presumption that 9/11 exposures could have resulted in the development of any and all types of cancer in the exposed populations. A presumption that any and all types of cancer could occur after exposure to 9/11 agents does not require any scientific evidence of a positive association between exposure and a type of cancer. The Administrator declined to determine inclusion of types of cancer based on a presumption approach. The STAC affirmatively rejected a recommendation to include any and all types of cancer to the List of WTC-Related Health Conditions. The Administrator made the policy decision to include only those types of cancer when a positive relationship has been established between exposure to the 9/11 agent and human cancer. Another alternative would be to rely on epidemiologic studies of the association of 9/11 exposures and the development of cancer or a type of cancer in 9/11-exposed populations exclusively. There are several limitations to using an exclusive 9/11 populations study approach. The Administrator finds that vast uncertainties exist in conducting epidemiologic studies of cancer in 9/11exposed populations. For example, there exists only very limited, individual exposure data in 9/11exposed populations. This lack of E:\FR\FM\13JNP2.SGM 13JNP2 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules personal, quantitative exposure data impedes the definitive epidemiologic evidence that exposure to 9/11 agents causes certain types of cancer in responder and survivor populations. In addition, cancer is generally a long latency set of diseases which in some cases may take many years or even decades to manifest clinically. Requiring evidence of positive associations from studies of 9/11exposed populations exclusively does not serve the best interests of WTC Health Program members. By expanding the scope of scientific information reviewed to include three complementary methods (including studies in 9/11 exposed populations and generally available epidemiologic criteria), the Administrator has developed a hierarchy of methods to guide consideration of whether to include types of cancers on the List of WTC-Related Health Conditions. erowe on DSK2VPTVN1PROD with PROPOSALS2 Effects on Other Agency Programs HHS finds that this rulemaking also has an effect on the VCF 39 administered by DOJ. DOJ administers the VCF under rules promulgated at 28 CFR part 104. The DOJ regulations define, in 28 CFR 104.2 (f), the term ‘‘WTC-related health condition’’ to mean ‘‘those health conditions identified as WTC-related by Title I of Public Law 111–347 and by regulations implementing that Title.’’ The preamble to the VCF final rule (76 FR 54115) states, ‘‘If the WTC Health Program determines that certain forms of cancer should be added to the list of WTC-related conditions, the final rule requires the Special Master to add such conditions to the list of presumptively covered conditions for the Fund.’’ Under the VCF program, compensation awards are generally calculated using three components: Economic loss plus non-economic loss minus collateral source payments. To determine economic loss, the Special Master considers any prior loss of earnings or other benefits related to employment, medical expense loss, replacement services loss, and loss of business or employment opportunity. 39 The September 11th Victim Compensation Fund of 2001 (VCF) was initially established in 2001 pursuant to Title IV of Public Law 107–42, 115 Stat. 230 (Air Transportation Safety and System Stabilization Act) and was open for claims from December 21, 2001, through December 22, 2003. Title II of the Zadroga Act amends and reactivates the September 11th Victim Compensation Fund of 2001. Public Law 111–347. Administered through DOJ by a Special Master, the VCF provides compensation to any individual (or a personal representative of a deceased individual) who suffered physical harm or was killed as a result of the terrorist-related aircraft crashes of September 11, 2001, or the debris removal efforts that took place in the immediate aftermath of those crashes. VerDate Mar<15>2010 15:06 Jun 12, 2012 Jkt 226001 The regulations provide presumed noneconomic awards for deceased individuals. Because every physical injury is unique, the Special Master may determine presumed non-economic losses on a case-by-case basis for physically injured claimants. The Special Master then subtracts any collateral offsets received or eligible to be received. The computation of individual compensation due under the fund is based on factors pertinent to each individual claimant. The statute caps the total amount of funds allocated to the VCF. The VCF regulation at 28 CFR 104.51 provides that, ‘‘the total amount of Federal funds paid for expenditures including compensation with respect to claims filed on or after October 3, 2011, will not exceed $2,775,000,000. Furthermore, the total amount of Federal funds expended during the period from October 3, 2011, through October 3, 2016, may not exceed $875,000,000.’’ To meet these requirements, the Special Master is authorized to reduce the amount of compensation due to each claimant by prorating the total amount of the compensation award determined for each individual claimant. The VCF intends to establish the fraction for proration such that all claimants receive some payment related to their claim within the overall funding limitation of the program. The Special Master may adjust the percentage of the total award that is to be paid to eligible claims based on experiential information as well as estimates related to potential future claims and availability of funds. The amount of compensation that would be awarded to each of the living claimants who develop, or the heirs of those who died from, a covered type of cancer during the years 2002 through 2016, would be determined by individual factors considered under the VCF. Depending on the total number of new claims and compensation eligibility, the overall impact on the VCF of increasing the number of eligible VCF claimants as a result of adding eligible health condition under the WTC Health Program may be to reduce the proration fraction that is applied to all VCF claimants such that the total cost to the government remains unchanged. The additional costs to the VCF due to processing and computing the entitlement for the extra claimants eligible as a result of having a covered type of cancer, plus the costs of paying newly covered claimants their prorated share of the compensation award, would result in amounts that will not be available to pay increased shares for the claimants with non-cancer conditions. PO 00000 Frm 00031 Fmt 4701 Sfmt 4702 35603 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. HHS believes that this rule has ‘‘no significant economic impact upon a substantial number of small entities’’ within the meaning of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). The WTC Health Program has contracted with the following healthcare providers and provider network managers to offer treatment and monitoring to enrolled responders and survivors: Seven Clinical Centers of Excellence (CCE), which serve responders and survivors in the New York City metropolitan area (City of New York Fire Department; Mount Sinai School of Medicine; Research Foundation of State University of New York; New York University, Bellevue Hospital Center; University of Medicine and Dentistry of New Jersey; Long Island Jewish Medical Center; and New York City Health and Hospitals Corporation); Logistics Health Incorporated, which manages the nationwide provider network for populations geographically distant from New York City; three Data Centers, which analyze CCE data and coordinate activities (City of New York Fire Department; Mount Sinai School of Medicine; and New York City Health and Hospitals Corporation); and Emdeon, which manages pharmacy benefits. Of these entities, six of the seven CCEs and two of the three Data Centers are hospitals (NAICS 622110—General Medical and Surgical Hospitals). The Small Business Administration (SBA) identifies as a small business those hospitals with average annual receipts below $34.5 million; none of the six fall below the SBA threshold for small businesses. The City of New York Fire Department’s Bureau of Health Services, which provides medical monitoring and treatment for FDNY members as a CCE, and provides data analysis and other services for the FDNY CCE as a Data Center, is considered a local government agency (NAICS 922160—Fire Protection), and as such cannot be considered a small entity by SBA. Finally, neither Logistics Health Incorporated, which manages the national provider network, nor Emdeon, which manages pharmacy benefits, (NAICS 551112—Management of Companies and Enterprises) falls below E:\FR\FM\13JNP2.SGM 13JNP2 35604 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules governments in the aggregate, or by the private sector. However, the rule may result in an increase in the contribution made by New York City for treatment and monitoring, as required by Title XXXIII, § 3331(d)(2). For 2012, the inflation adjusted threshold is $139 million. SBA’s $7 million threshold for small businesses in that sector. Because no small businesses are impacted by this rulemaking, HHS certifies that this rule will not have a significant economic impact on a substantial number of small entities within the meaning of the RFA. Therefore, a regulatory flexibility analysis as provided for under RFA is not required. 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. 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, 2014). HHS has determined that no changes are needed to the information collection request already approved by OMB. 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. erowe on DSK2VPTVN1PROD with PROPOSALS2 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 by State, local or Tribal VerDate Mar<15>2010 15:06 Jun 12, 2012 Jkt 226001 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 been reviewed carefully to eliminate drafting errors and ambiguities. G. Executive Order 13132 (Federalism) HHS 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, HHS has evaluated the environmental health and safety effects of this proposed rule on children. HHS has determined that the rule would have no environmental health and safety effect on children, although an eligible child who has been diagnosed with a cancer type specified in this rulemaking may seek certification of the condition by the Administrator. I. Executive Order 13211 (Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use) In accordance with Executive Order 13211, HHS 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. PO 00000 Frm 00032 Fmt 4701 Sfmt 4702 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. HHS has attempted to use plain language in promulgating the proposed rule consistent with the Federal Plain Writing Act guidelines and requests comment from the public regarding this requirement. VI. Proposed Rule List of Subjects in 42 CFR Part 88 Aerodigestive disorders, Appeal procedures, Cancer, Health care, Mental health conditions, Musculoskeletal disorders, Respiratory and pulmonary diseases. For the reasons discussed in the preamble, the Department of Health and Human Services proposes to amend 42 CFR part 88 as follows: PART 88—WORLD TRADE CENTER HEALTH PROGRAM 1. The authority citation for Part 88 continues to read as follows: Authority: 42 U.S.C. 300mm–300mm–61, Pub. L. 111–347, 124 Stat. 3623. § 88.1 [Amended] 2. Amend § 88.1 by adding paragraph (4) to the definition of ‘‘List of WTCrelated health conditions’’ to read as follows: § 88.1 Definitions. * * * * * List of WTC-related health conditions * * * * * * * * (4) Cancers: This list includes those individual cancer types specified in Table 1, below, according to the International Classification of Diseases, 10th Edition (ICD–10) and International Classification of Diseases, 9th Edition (ICD–9). BILLING CODE P E:\FR\FM\13JNP2.SGM 13JNP2 VerDate Mar<15>2010 15:06 Jun 12, 2012 Jkt 226001 PO 00000 Frm 00033 Fmt 4701 Sfmt 4725 E:\FR\FM\13JNP2.SGM 13JNP2 35605 EP13JN12.009</GPH> erowe on DSK2VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules VerDate Mar<15>2010 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules 15:06 Jun 12, 2012 Jkt 226001 PO 00000 Frm 00034 Fmt 4701 Sfmt 4725 E:\FR\FM\13JNP2.SGM 13JNP2 EP13JN12.010</GPH> erowe on DSK2VPTVN1PROD with PROPOSALS2 35606 VerDate Mar<15>2010 15:06 Jun 12, 2012 Jkt 226001 PO 00000 Frm 00035 Fmt 4701 Sfmt 4725 E:\FR\FM\13JNP2.SGM 13JNP2 35607 EP13JN12.011</GPH> erowe on DSK2VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules VerDate Mar<15>2010 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules 15:06 Jun 12, 2012 Jkt 226001 PO 00000 Frm 00036 Fmt 4701 Sfmt 4725 E:\FR\FM\13JNP2.SGM 13JNP2 EP13JN12.012</GPH> erowe on DSK2VPTVN1PROD with PROPOSALS2 35608 VerDate Mar<15>2010 15:06 Jun 12, 2012 Jkt 226001 PO 00000 Frm 00037 Fmt 4701 Sfmt 4725 E:\FR\FM\13JNP2.SGM 13JNP2 35609 EP13JN12.013</GPH> erowe on DSK2VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules VerDate Mar<15>2010 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules 15:06 Jun 12, 2012 Jkt 226001 PO 00000 Frm 00038 Fmt 4701 Sfmt 4725 E:\FR\FM\13JNP2.SGM 13JNP2 EP13JN12.014</GPH> erowe on DSK2VPTVN1PROD with PROPOSALS2 35610 VerDate Mar<15>2010 15:06 Jun 12, 2012 Jkt 226001 PO 00000 Frm 00039 Fmt 4701 Sfmt 4725 E:\FR\FM\13JNP2.SGM 13JNP2 35611 EP13JN12.015</GPH> erowe on DSK2VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules VerDate Mar<15>2010 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules 15:06 Jun 12, 2012 Jkt 226001 PO 00000 Frm 00040 Fmt 4701 Sfmt 4725 E:\FR\FM\13JNP2.SGM 13JNP2 EP13JN12.016</GPH> erowe on DSK2VPTVN1PROD with PROPOSALS2 35612 VerDate Mar<15>2010 15:06 Jun 12, 2012 Jkt 226001 PO 00000 Frm 00041 Fmt 4701 Sfmt 4725 E:\FR\FM\13JNP2.SGM 13JNP2 35613 EP13JN12.017</GPH> erowe on DSK2VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules VerDate Mar<15>2010 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules 15:06 Jun 12, 2012 Jkt 226001 PO 00000 Frm 00042 Fmt 4701 Sfmt 4725 E:\FR\FM\13JNP2.SGM 13JNP2 EP13JN12.018</GPH> erowe on DSK2VPTVN1PROD with PROPOSALS2 35614 35615 Dated: May 31, 2012. John 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. 2012–14203 Filed 6–8–12; 4:15 pm] BILLING CODE C VerDate Mar<15>2010 15:06 Jun 12, 2012 Jkt 226001 PO 00000 Frm 00043 Fmt 4701 Sfmt 9990 E:\FR\FM\13JNP2.SGM 13JNP2 EP13JN12.019</GPH> erowe on DSK2VPTVN1PROD with PROPOSALS2 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Proposed Rules

Agencies

DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 77, Number 114 (Wednesday, June 13, 2012)]
[Proposed Rules]
[Pages 35574-35615]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-14203]

[[Page 35573]]

Vol. 77

Wednesday,

No. 114

June 13, 2012

Part IV

Department of Health and Human Services

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42 CFR Part 88

World Trade Center Health Program; Addition of Certain Types of Cancer
to the List of WTC-Related Health Conditions; Proposed Rule

Federal Register / Vol. 77 , No. 114 / Wednesday, June 13, 2012 /
Proposed Rules

[[Page 35574]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Docket No. CDC-2012-0007; NIOSH-257]

42 CFR Part 88

RIN 0920-AA49

World Trade Center Health Program; Addition of Certain Types of
Cancer to the List of WTC-Related Health Conditions

AGENCY: Centers for Disease Control and Prevention, HHS.

ACTION: Notice of proposed rulemaking.

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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,
which is administered by the Director of the National Institute for
Occupational Safety and Health (NIOSH), within the Centers for Disease
Control and Prevention (CDC), provides medical monitoring and treatment
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, and to eligible survivors
of the New York City attacks. In accordance with our regulations, which
establish procedures for adding a new condition to the list of health
conditions covered by the WTC Health Program, this proposed rule would
add certain types of cancer to the List of WTC-Related Health
Conditions.

DATES: Comments must be received by July 13, 2012.

ADDRESSES: Written Comments: You may submit comments by any 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-C34, 4676 Columbia Parkway, Cincinnati, OH 45226.
Facsimile: (513) 533-8285.
Instructions: All submissions received must include the agency name
(Centers for Disease Control and Prevention, HHS) and docket number
(CDC-2012-007; NIOSH-257) or Regulation Identifier Number (0920-AA49)
for this rulemaking. All relevant comments, including any personal
information provided, will be posted without change to https://www.regulations.gov. For detailed instructions on submitting public
comments, see the ``Public Participation'' heading of the SUPPLEMENTARY
INFORMATION section of this document.
Docket: For access to the docket to read background documents, go
to https://www.regulations.gov or https://www.cdc.gov/niosh/docket/archive/docket257.html.

FOR FURTHER INFORMATION CONTACT: Frank J. Hearl, PE, Chief of Staff,
National Institute for Occupational Safety and Health, Centers for
Disease Control and Prevention, Patriots Plaza, Suite 9200, 395 E St.
SW., Washington, DC 20201. Telephone: (202) 245-0625 (this is not a
toll-free number). Email: WTCpublicinput@cdc.gov.

SUPPLEMENTARY INFORMATION: This notice of proposed rulemaking is
organized as follows:

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. Addition of Health Conditions to the List of WTC-Related
Health Conditions
C. Need for Rulemaking
D. Addition of Certain Types of Cancer to the List of WTC-
Related Health Conditions
1. Scientific/Technical Advisory Committee (STAC)
Recommendations
2. Administrator's Review of Available Scientific Information
and the STAC's Recommendations
3. Methods Used by the Administrator to Determine Whether to Add
Cancer or Types of Cancer to the List of WTC-Related Health
Conditions
4. Administrator's Determination Concerning Petition 001
5. Explanations for Adding Certain Types of Cancer to the List
of WTC-Related Health Conditions
6. Certification and Treatment of WTC-Related Health Conditions
Including Types of Cancer
7. Endnotes
E. Effects of Rulemaking on Federal Agencies
IV. Summary of Proposed Rule
V. Regulatory Assessment Requirements
A. Executive Order 12866 and Executive Order 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
VI. Proposed Rule

I. Executive Summary

A. Purpose of Regulatory Action

Title I of the James Zadroga 9/11 Health and Compensation Act of
2010 (Pub. L. 111-347), amended the Public Health Service Act (PHS Act)
establishing the World Trade Center (WTC) Health Program within the
Department of Health and Human Services (HHS). The PHS Act requires the
WTC Program Administrator (Administrator) to conduct rulemaking to
propose the addition of a health condition to the List of WTC-Related
Health Conditions (List) codified in 42 CFR 88.1 whether the
Administrator adds a health condition based on the findings from
periodic reviews of cancer,\1\ based on a request from a petition, or
based on a determination made at the Administrator's discretion that a
proposed rule adding a condition should be initiated. Following a
petition to add cancer or certain types of cancer to the List and a
recommendation by the WTC Health Program's Scientific/Technical
Advisory Committee (STAC), the Administrator is following the
procedures established in 42 CFR 88.17 to add some, but not all types
of cancer recommended by the petition.
---------------------------------------------------------------------------

\1\ See PHS Act, Title XXXIII Sec. 3312(a)(5).
---------------------------------------------------------------------------

B. Summary of Major Provisions

This rule modifies the List of WTC-Related Health Conditions in 42
CFR 88.1 to add the following conditions (types of cancer identified by
ICD-10 code are specified in the discussion below):

[ssquf] Malignant neoplasms of the lip, tongue, salivary gland, floor
of mouth, gum and other mouth, tonsil, oropharynx, hypopharynx, and
other oral cavity and pharynx
[ssquf] Malignant neoplasm of the nasopharynx
[ssquf] Malignant neoplasms of the nose, nasal cavity, middle ear, and
accessory sinuses
[ssquf] Malignant neoplasm of the larynx
[ssquf] Malignant neoplasm of the esophagus
[ssquf] Malignant neoplasm of the stomach
[ssquf] Malignant neoplasm of the colon and rectum
[ssquf] Malignant neoplasm of the liver and intrahepatic bile duct
[ssquf] Malignant neoplasms of the retroperitoneum and peritoneum,
omentum, and mesentery
[ssquf] Malignant neoplasms of the trachea; bronchus and lung; heart,
mediastinum and pleura; and other ill-defined sites in the respiratory
system and intrathoracic organs

[[Page 35575]]

[ssquf] Mesothelioma
[ssquf] Malignant neoplasms of the soft tissues (sarcomas)
[ssquf] Malignant neoplasms of the skin (melanoma and non-melanoma),
including scrotal cancer
[ssquf] Malignant neoplasm of the breast
[ssquf] Malignant neoplasm of the ovary
[ssquf] Malignant neoplasm of the urinary bladder
[ssquf] Malignant neoplasm of the kidney
[ssquf] Malignant neoplasms of renal pelvis, ureter and other urinary
organs
[ssquf] Malignant neoplasms of the eye and orbit
[ssquf] Malignant neoplasm of the thyroid
[ssquf] Malignant neoplasms of the blood and lymphoid tissues
(including, but not limited to, lymphoma, leukemia, and myeloma)
[ssquf] Childhood cancers
[ssquf] Rare cancers

The Administrator developed a hierarchy of methods (detailed in
section III.D of this preamble) for determining which cancers to
propose for inclusion on the List of WTC-Related Health Conditions. HHS
is seeking comments on the proposed methods in this rule.

C. Costs and Benefits

Annual costs, benefits, and transfers of this rule are listed in
the table below. This analysis estimates the impact on WTC Health
Program costs using the number of persons currently enrolled in the
program as responders and survivors and assumes that the rate of cancer
in the population will be equal to the U.S. population average rate. An
alternative analysis considers the impact on costs if the Program
enrolls additional persons up to the Program's statutory limits, and
that the expanded population experiences a 21 percent higher rate of
cancer than the U.S. population average. The basis for these
assumptions is explained in detail in the preamble of this rulemaking.
Although we cannot quantify the benefits associated with the WTC
Health Program, enrollees with cancer are expected to experience a
higher quality of care than they would in the absence of the Program.
Mortality and morbidity improvements for cancer patients expected to
enroll in the WTC Health Program are anticipated because barriers may
exist to access and delivery of quality health care services for cancer
patients in the absence of the services provided by the WTC Health
Program. HHS anticipates benefits to cancer patients treated through
the WTC Health Program, who may otherwise not have access to health
care services, to accrue in 2013. Starting in 2014, continued
implementation of the Affordable Care Act will result in increased
access to health insurance and improved health care services for the
general responder and survivor population that currently is uninsured.

Estimated Annual WTC Health Program Costs, Benefits, and Transfers, 55,000 Responders and 5,000 Survivors at
U.S. Population Cancer Rate, and 80,000 Responders and 30,000 Survivors at U.S. Population Cancer Rate + 21
Percent, 2013-2016, 2011$
----------------------------------------------------------------------------------------------------------------

----------------------------------------------------------------------------------------------------------------
Societal Costs for 2013, 2011$
Annualized Transfers for 2013-2016,
2011$
---------------------------------------------------------------------------
Based on the 16.3 percent of general Discounted at 7 Discounted at 3
responders and survivors who are percent percent
expected to be uninsured
---------------------------------------------------------------------------
Cancer Rate
Cancer Rate
---------------------------------------------------------------------------
U.S. Average U.S. + 21% U.S. Average U.S. + 21%
---------------------------------------------------------------------------
55,000 Responders................... $1,648,706 ................. $10,172,308 .................
5,000 Survivors..................... 271,427 ................. 1,572,907 .................
Colorectal and Breast Screening..... 204,491 ................. 713,321 .................
---------------------------------------------------------------------------
60,000 Total.................... 2,124,624 ................. 12,458,535 .................
----------------------------------------------------------------------------------------------------------------
80,000 Responders................... ................. $2,631,100 ................. $19,912,464
30,000 Survivors.................... ................. 1,970,560 ................. 12,124,118
Colorectal and Breast Screening..... ................. 417,521 ................. 1,271,478
---------------------------------------------------------------------------
110,000 Total................... ................. 5,019,182 ................. 33,308,060
----------------------------------------------------------------------------------------------------------------
Qualitative benefits:
Although we cannot quantify the benefits associated with the WTC Health Program, enrollees with cancer are
expected to experience a higher quality of care than they would in the absence of the Program. Mortality and
morbidity improvements for cancer patients expected to enroll in the WTC Health Program are anticipated because
barriers may exist to access and delivery of quality health care services for cancer patients in the absence of
the services provided by the WTC Health Program. HHS anticipates benefits to cancer patients treated through
the WTC Health Program, who may otherwise not have access to health care services, to accrue in 2013. Starting
in 2014, continued implementation of the Affordable Care Act will result in increased access to health
insurance and improved health care services for the general responder and survivor population that currently is
uninsured.
----------------------------------------------------------------------------------------------------------------

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. Do not include any information in your comment or
supporting materials that you consider confidential or inappropriate
for public disclosure. Comments are invited on any topic related to
this proposed rule. The Administrator is seeking comments from the
public on the following specific topics:
1. The four methods proposed to evaluate evidence for the addition
of types of cancer to the List of WTC-Related Health Conditions;
2. Information or published studies about the type of welding that
occurred in the New York City disaster area, at the Pentagon, or at
Shanksville, Pennsylvania with regard to metal

[[Page 35576]]

cutting not involving exposure to ultraviolet light and welding
involving ultraviolet light exposure; and
3. Information or published studies about work hours scheduling or
shiftwork occurring in the New York City disaster area, at the
Pentagon, or in Shanksville, Pennsylvania.
Comments submitted electronically or by mail should be titled
``Docket No. CDC-2012-0007; NIOSH-257,'' addressed to the ``NIOSH
Docket Officer,'' and should identify the author(s) and contact
information (such as return address, email address, or phone number),
in case clarification is needed. Electronic and written comments can be
submitted to the addresses provided in the ADDRESSES section, above.
All communications received on or before the closing date for comments
will be fully considered by the Administrator of the WTC Health
Program.

III. Background

A. WTC Health Program Statutory Authority

Title I of the James Zadroga 9/11 Health and Compensation Act of
2010 (Pub. L. 111-347), amended the Public Health Service Act (PHS Act)
to add Title XXXIII \2\ establishing the World Trade Center (WTC)
Health Program within the Department of Health and Human Services
(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, and to
eligible survivors of the New York City attacks.
---------------------------------------------------------------------------

\2\ Title XXXIII of the Public Health Service 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
World Trade Center Health Program and are codified elsewhere.
---------------------------------------------------------------------------

All references to the Administrator of the WTC Health Program
(Administrator) in this notice mean the NIOSH Director or his or her
designee. Title XXXIII, Sec. 3312(a)(6) of the PHS Act requires the
Administrator to conduct rulemaking to propose the addition of a health
condition to the List of WTC-Related Health Conditions (List) codified
in 42 CFR 88.1.

B. Addition of Health Conditions to the List of WTC-Related Health
Conditions

Under 42 CFR 88.17, the Administrator has established a process by
which health conditions may be considered for addition to the List of
WTC-Related Health Conditions in Sec. 88.1. Pursuant to Sec.
3312(a)(6) of Title XXXIII of the PHS Act, the Administrator is
required to publish a notice of proposed rulemaking and allow
interested parties to comment on the proposed rule. The proposed rule
may be initiated by the Administrator whenever he or she determines
that a proposed rule should be promulgated to add a health condition
(e.g., when a review of WTC Health Program monitoring data reveals the
prevalence of a condition not previously identified in Title XXXIII or
by the Program), on the basis of the WTC Health Program's periodic
review of all available scientific and medical evidence of cancer or a
certain type of cancer pursuant to Sec. 3312(a)(5) of Title XXXIII, or
in response to a petition submitted by an interested party. Upon
receipt of a petition from an interested party to add a condition to
the List of WTC-Related Health Conditions, the Administrator is
authorized to request a recommendation of the WTC Health Program STAC;
or publish a proposed rule to add such health condition; or publish the
Administrator's determination not to publish a proposed rule and the
basis for that determination; or to publish a determination that
insufficient evidence exists to take action.

C. Need for Rulemaking

On September 7, 2011, the Administrator of the WTC Health Program
received a written petition to add a health condition to the List of
WTC-Related Health Conditions (Petition 001). Petition 001 requested
that the Administrator ``consider adding coverage for cancer under the
Zadroga Act'' to the List in Sec. 88.1. [Maloney, et al. 2011]
On October 5, 2011, the Administrator formally exercised his option
to request a recommendation from the STAC regarding the petition (PHS
Act, Title XXXIII, Sec. 3312(a)(6)(B)(i); 42 CFR 88.17(a)(2)(i)). The
Administrator requested that the STAC ``review the available
information on cancer outcomes associated with the exposures resulting
from the September 11, 2001, terrorist attacks, and provide advice on
whether to add cancer, or a certain type of cancer, to the List
specified in the Zadroga Act.'' [Howard 2011] The background to this
rulemaking and a discussion of the STAC's recommendation are provided
below.

D. Addition of Certain Types of Cancer to the List of WTC-Related
Health Conditions

To determine whether the scientific evidence is sufficient to
support the addition of cancer or types of cancer to the List of WTC-
Related Health Conditions, the Administrator considered data from five
information sources: (1) Peer-reviewed studies published in the
scientific literature, including environmental sampling data,
epidemiologic studies on the 9/11 exposed populations, and studies
providing evidence of a causal relationship between a type of cancer
and a condition already on the List of WTC-Related Health Conditions;
(2) findings and recommendations solicited from the WTC Clinical
Centers of Excellence and Data Centers, the WTC Health Registry at the
New York City Department of Health and Mental Hygiene, and the New York
State Department of Health; (3) information from the public solicited
through a request for information published in the Federal Register on
March 8, 2011 and March 29, 2011; (4) the findings of the National
Toxicology Program (NTP) in the National Institute of Environmental
Health Sciences, HHS, as well as the World Health Organization's
International Agency for Research on Cancer (IARC); and (5) findings
from other sources of information relevant to 9/11 exposures, including
the expert judgment and personal experiences of STAC members, and
comments from the public.
NTP, an interagency program that evaluates agents of public health
concern using toxicology and molecular biology, publishes the biennial
Report on Carcinogens (RoC), which contains a list of human
carcinogens, exposure information, and descriptions of Federal exposure
limits.\3\ The RoC classifies agents in one of two ways: known to be a
human carcinogen, and reasonably anticipated to be a human carcinogen;
this classification is determined by an expert panel convened for each
candidate substance and is based on an evaluation of the published,
peer-reviewed literature and reviews conducted by Federal agencies and
IARC. Unlike IARC, NTP does not identify specific types of cancer that
have sufficient evidence of carcinogenicity.
---------------------------------------------------------------------------

\3\ NTP Report on Carcinogens (RoC). https://ntp.niehs.nih.gov/?objectid=72016262-BDB7-CEBA-FA60E922B18C2540. Accessed May 9, 2012.
---------------------------------------------------------------------------

IARC, which coordinates and conducts research on the causes of
human cancer and the mechanisms of carcinogenesis, maintains a series
of

[[Page 35577]]

Monographs on the carcinogenic risks to humans caused by chemicals,
complex mixtures, occupational exposures, physical agents, biological
agents, and lifestyle factors. In the Monographs, carcinogens are
categorized according to whether they provide sufficient evidence of
carcinogenicity in humans for a certain type of cancer (Group 1); or
limited evidence of carcinogenicity in humans, including agents
probably carcinogenic to humans (Group 2A) and agents possibly
carcinogenic to humans (Group 2B); whether they are not classifiable as
to carcinogenicity in humans (Group 3); or whether there is evidence
suggesting lack of carcinogenicity (Group 4).\4\ IARC convenes working
groups of international experts to develop each Monograph based on
reviews of epidemiological, animal, and mechanistic data ``that have
been published or accepted for publication in the openly available
scientific literature,'' although ``[i]n certain instances, government
agency reports that have undergone peer review and are widely available
are considered.'' [IARC 2006]
---------------------------------------------------------------------------

\4\ WHO International Agency for Research on Cancer (IARC).
https://monographs.iarc.fr/. Accessed May 8, 2012.
---------------------------------------------------------------------------

In July 2011, the Administrator released the First Periodic Review
of the Scientific and Medical Evidence Related to Cancer for the World
Trade Center Health Program (First Periodic Review). [NIOSH 2011] As
required by Title XXXIII, Sec. 3312(a)(5)(A) of the PHS Act, the
Administrator reviewed ``all available scientific and medical evidence,
including findings and recommendations of Clinical Centers of
Excellence, published in peer-reviewed journals to determine if, based
on such evidence, cancer or a certain type of cancer should be added to
the applicable list of WTC-related health conditions.'' As described in
the First Periodic Review, environmental sampling identified 287
chemicals and chemical groups as present in the New York City disaster
area (referred to herein as ``9/11 agents'' \5\). [COPC 2003] Published
exposure assessments reviewed by the Administrator in the First
Periodic Review ``suggest that responders and others in the nearby area
were potentially exposed to one or more of the substances designated by
IARC and NTP as known or reasonably anticipated human carcinogens,
although generally not in excess of applicable occupational exposure
limits.'' [NIOSH 2011]
---------------------------------------------------------------------------

\5\ Several other agents were recommended by the STAC, verified
in the published literature, and are also considered 9/11 agents.
The agents identified at the Pentagon and in Shanksville,
Pennsylvania were reviewed but no additional agents were identified.
---------------------------------------------------------------------------

At the time of publication, the First Periodic Review [NIOSH 2011]
identified only one peer-reviewed article addressing the association of
exposures arising from the September 11, 2001, terrorist attacks and
cancer in responders and survivors, and two publications that used
models to estimate the risk of cancer among residents in Lower
Manhattan. The Administrator used a ``weight of the evidence'' approach
to evaluate data derived from information sources (1)-(3), discussed
above, and reported that insufficient evidence existed at that time to
propose the addition of cancer or certain types of cancer to the List
of WTC-Related Health Conditions.
In September 2011, an epidemiologic study was published in The
Lancet. The study, by Rachel Zeig-Owens and colleagues, ``identified a
modest effect of WTC exposure for all cancers combined by comparing the
ratios in the exposed group [of Fire Department of New York City
firefighters] to those in the non-exposed group.'' [Zeig-Owens, et al.
2011] This publication led to the submission of Petition 001.
In the petition, which was received shortly after publication of
the Zeig-Owens study, the petitioners stated they ``read with great
concern * * * the study conducted by the New York City Fire Department
and published last week in The Lancet that indicated an elevated risk
of melanoma, thyroid and prostate cancer, and non-Hodgkin lymphoma
among firefighters who served at ground zero.'' While they ``feel
strongly there must be a scientific basis for adding coverage for new
conditions under the Zadroga Act,'' petitioners state that ``given the
severity of the illnesses reported in The Lancet, we also want to make
sure that this and other peer-reviewed studies linking cancers to the
[September 11, 2001] attacks are evaluated as expeditiously as
possible.'' [Maloney, et al. 2011]
Title XXXIII, Sec. 3302(a)(1) establishes the STAC, and charges it
to ``review scientific and medical evidence and to make recommendations
to the Administrator on additional WTC Program eligibility criteria and
on additional WTC-related health conditions.'' Accordingly, when asked
by the Administrator to provide a recommendation on Petition 001, the
STAC established evidentiary criteria and assessed the weight of the
available scientific evidence provided by information sources (1), (4),
and (5), described above. The STAC found support for including a number
of types of cancer based in part on evidence of increased risk reported
in Zeig-Owens.\6\ The STAC also included a number of types of cancer
based on the professional judgment of STAC members with scientific
expertise, on the personal experience of some of the STAC members who
were themselves WTC responders or survivors, and on comments made by
the public.
---------------------------------------------------------------------------

\6\ Limitations of the Zeig-Owens study include: Limited
information on specific exposures experienced by firefighters; short
time for follow-up of cancer outcomes; speculation about the
biological plausibility of chronic inflammation as a possible
mediator between WTC-exposure and cancer outcomes; and potential
unmeasured confounders.
---------------------------------------------------------------------------

Unlike the explicit language in Title XXXIII, Sec. 3312(a)(5)(A)
of the PHS Act, which prescribes the standard to be used in the
periodic reviews of cancer, Sec. 3312(a)(6) does not specifically
limit the type of sources upon which the Administrator may base his or
her determination to propose the addition of cancer or types of cancer
to the List of WTC-Related Health Conditions. In this action, the
Administrator's determination is based on the information sources used
in the First Periodic Review, the NTP's RoC, the IARC Monographs, and
from all other scientific information provided by the STAC, including
the Zeig-Owens study which has been added to the peer-reviewed
epidemiologic literature and is discussed below.
As discussed extensively below, the Administrator has adopted a
formal methodology to evaluate the available scientific evidence. The
formal methodology follows on criteria used by the STAC in its
recommendation and is presented below, in section III.D.3.\7\
---------------------------------------------------------------------------

\7\ The Administrator's methodology does not incorporate the
standard established in Title XXXIII, Sec. 3312(a)(2) to determine
whether an individual can be diagnosed with a WTC-related health
condition--that individual standard requires a determination that
the terrorist attacks ``were substantially likely to be a
significant factor in aggravating, contributing to, or causing the
[individual's] illness or health condition.'' The WTC Health Program
regulations at 42 CFR 88.1 define the ``List of WTC-related health
conditions'' differently than a ``WTC-related health condition'' [in
an individual]. For more information on the topic of certification
of an individual, see Section III.D.6. below.
---------------------------------------------------------------------------

Based upon the new methodology, the Administrator proposes to add
the types of cancer identified in section III.D.4., below, to the List
of WTC-Related Health Conditions. The Administrator seeks comment on
the methods developed, and the application of those methods, to add
cancer or a type of cancer to the List of WTC-Related Health
Conditions.

[[Page 35578]]

1. STAC Recommendations
In response to the Administrator's October 5, 2011 request, the
STAC met on three occasions--November 9-10, 2011, February 15-16, 2012,
and March 28, 2012--to deliberate and develop recommendations on
Petition 001 for the Administrator's consideration. The Administrator
received the STAC recommendations on April 2, 2012. [STAC 2012]
In its April 2, 2012 recommendation to the Administrator, the chair
of the STAC wrote that the STAC had:

[R]eviewed available information on cancer outcomes that may be
associated with the exposures resulting from the September 11, 2001,
terrorist attacks, and believes that exposures resulting from the
collapse of the buildings and high-temperature fires are likely to
increase the probability of developing some or all cancers. This
conclusion is based primarily on the presence of approximately 70
known and potential carcinogens in the smoke, dust, volatile and
semi-volatile contaminants identified at the World Trade Center
site. Fifteen of these substances are classified by the
International Agency for Research on Cancer (IARC) as known to cause
cancer in humans, and 37 are classified by the National Toxicology
Program (NTP) as reasonably anticipated to cause cancer in humans;
others are classified by IARC as probable and possible carcinogens.
Many of these carcinogens are genotoxic and it is therefore assumed
that any level of exposure carries some risk. [STAC 2012]

In its recommendation, the STAC also noted that ``exposure data are
extremely limited.'' The STAC summarized the state of exposure
assessment relevant to the terrorist attacks in New York City:

No data were collected in the first 4 days after the attacks [in
New York City], when the highest levels of air contaminants
occurred, and the variety of samples taken on or after September 16,
2001 are insufficient to provide quantitative estimates of exposure
on an individual or area level. However, the committee considers
that the high prevalence of acute symptoms and chronic conditions
observed in large numbers of rescue, recovery, cleanup and
restoration workers and survivors, as well as qualitative
descriptions of exposure conditions in downtown Manhattan, represent
highly credible evidence that significant toxic exposures occurred.
Furthermore, the salient biological reaction that underlies many
currently recognized WTC health conditions--persistent
inflammation--is now believed to be an important mechanism
underlying cancer through generating DNA-reactive substances,
increasing cell turnover, and releasing biologically active
substances that promote tumor growth, invasion and metastasis.

In its recommendation to the Administrator, the STAC wrote:

The committee deliberated on whether to designate all cancers as
WTC-related conditions or to list only cancers with the strongest
evidence. Some members proposed to include all cancers based on the
incomplete and limited epidemiological data available to identify
specific cancers, and others argued for the alternative of listing
specific cancers based on best available evidence. The committee
agreed to proceed by generating a list of cancers potentially
related to WTC exposures based on evidence from three sources. [STAC
2012]

The STAC based its Petition 001 recommendation regarding the
addition of certain types of cancer on evidence from four sources:

1. 9/11 agents (those known and potential carcinogens identified
in the New York City disaster area) with limited or sufficient
evidence of carcinogenicity in humans based on International Agency
for Research on Cancer (IARC) Monographs on the Evaluation of
Carcinogenic Risks to Humans \8\;
---------------------------------------------------------------------------

\8\ See IARC https://monographs.iarc.fr/ENG/Monographs/PDFs/index.php.
---------------------------------------------------------------------------

2. Cancers arising from regions of the respiratory and digestive
tracts where inflammatory conditions, such as gastroesophageal
reflux disease (GERD), have been documented;
3. Cancers for which epidemiologic studies have found some
evidence of increased risk in WTC responder and survivor
populations; and
4. Findings from other sources of information relevant to 9/11
exposures and the potential occurrence of cancer, including the
expert judgment and personal experiences of STAC members, and
comments from the public.

Based on these four evidentiary sources, the STAC recommended to
the Administrator that the following 14 cancer groups, encompassing
many types of cancer, be added to the List of WTC-Related Health
Conditions in 42 CFR 88.1:

1. Malignant neoplasms of the respiratory system (including
nose, nasal cavity and middle ear, larynx, lung and bronchus,
pleura, trachea, mediastinum, and other respiratory organs);
2. Certain cancers of the digestive system, including esophagus,
stomach, colon and rectum, liver and intrahepatic bile duct,
retroperitoneum, peritoneum, omentum, and mesentery;
3. Cancers of the oral cavity and pharynx, including lip,
tongue, salivary gland, floor of mouth, gum and other mouth,
nasopharynx, tonsil, oropharynx, hypopharynx and other oral cavity,
and pharynx;
4. Soft tissue sarcomas;
5. Melanoma and non-melanoma skin cancers, including scrotal
cancer;
6. Mesothelioma of the pleura and peritoneum;
7. Cancer of the ovary;
8. Cancers of the urinary tract, including urinary bladder,
kidney and renal pelvis, ureter, and other urinary organs;
9. Cancer of the eye and orbit;
10. Thyroid cancer;
11. Lymphoma, leukemia, and myeloma;
12. Breast cancer;
13. Childhood cancers (all cancers diagnosed in persons less
than 20 years old); and
14. Rare cancers.

In its recommendation to the Administrator, the STAC also made four
additional points.
First, the STAC recommended that as new epidemiologic studies of 9/
11-exposed populations become available, the studies' findings ``be
reviewed and modifications made to the list as appropriate.'' [STAC
2012]
Second, the STAC recommended that the WTC Health Program provide
funding and guidelines for medical screening and early detection of
cancer and appropriate counseling. [STAC 2012]
Third, the STAC emphasized that although evidence of
carcinogenicity of 9/11 agents from animal studies or mechanistic
studies exists,

because there is limited concordance between specific cancer sites
affected in humans and in animals, only those substances classified
based on human data are informative regarding organ sites of
carcinogenicity in humans. [STAC 2012]

Fourth, the STAC noted:

In addition to the evidence considered by the committee to
identify potential WTC-related cancers, arguments in favor of
listing cancer as a WTC-related condition include the presence of
multiple exposures and mixtures with the potential to act
synergistically and to produce unexpected health effects; the major
gaps in the data with respect to the range and levels of
carcinogens, the potential for heterogeneous exposures and hot spots
representing exceptionally high or unique exposures both on the WTC
site and in surrounding communities, the potential for
bioaccumulation of some of the compounds, limitations of testing for
carcinogenicity of many of the 287 agents and chemical groups cited
in the first NIOSH Periodic Review, and the large volume of toxic
materials present in the WTC towers. [STAC 2012]

Finally, the STAC stated that

[A]lthough acknowledging some lack of certainty in the evidence
for targeting specific organs or organ site groupings as WTC-
related, the majority of the committee agreed that recommending the
specified cancer sites and site groupings was based on a sound
scientific rationale and the best evidence available to date. [STAC
2012]
2. Administrator's Review of Available Scientific Information and the
STAC's Recommendations
The Administrator agrees with the STAC that individual exposure
assessment information arising from the terrorist attacks is extremely
limited and that its absence impairs definitive

[[Page 35579]]

scientific analysis of the relationship between exposures arising from
the attacks and the occurrence of any specific type of cancer. Also
absent at the present time are multiple epidemiologic studies of cancer
in exposed responders and survivors which definitively support an
association between 9/11 exposures and specific types of cancer that
would meet generally well-accepted criteria indicating that the
association is a causal one.
As noted in the First Periodic Review:

Drawing causal inferences about exposures resulting from the
September 11, 2001, terrorist attacks and the observation of cancer
cases in responders and survivors is especially challenging since
cancer is not a rare disease. In the United States, the probability
that a person will develop cancer during their lifetime is one in
two for men and one in three for women [ACS 2010]. This `background'
rate of cancer development would be expected in responders and
survivors even if the September 11, 2001, terrorist attacks had
never occurred. Determining, then, if the September 11, 2001,
exposures are contributing to an additional burden of cancer in
responders and survivors is a scientific challenge. [NIOSH 2011]

Also noted in the First Periodic Review, an important framework
used by epidemiologists to assess the causal nature of an observed
association is the ``Bradford Hill criteria.'' [Hill 1965] The criteria
are not intended to be a rigorous checklist, although they are often
viewed in that way. None of the nine Bradford Hill criteria are alone
sufficient to establish causation; together they can provide a starting
point in evaluating whether an observed association is indeed a causal
one. Five of those criteria are used by the Administrator in this
rulemaking to evaluate evidence of a causal relationship between 9/11
exposures and a type of cancer: Strength of the association reported in
the study between exposure agents and the type of cancer; consistency
of the findings across multiple studies of exposed populations;
biological gradient or dose-response relationship between exposures and
the type of cancer; and plausibility and coherence of the findings with
known facts about the biology of the type of cancer.\9\
---------------------------------------------------------------------------

\9\ Four Bradford Hill criteria were not considered because,
while useful in considering all sources of information, as the NTP
and IARC reviews do, they have limited value when considering only
the cancer epidemiologic studies of the 9/11-exposed population.
Analogy establishes that if one exposure causes cancer, then a
similar exposure should cause a similar cancer. This criterion is
most useful with a large body of evidence. Specificity is not useful
since many cancers are caused by multiple exposures. Temporal
relationship establishes that exposure always precedes the outcome.
Experiment establishes that the condition can be altered (prevented
or ameliorated) by an appropriate experimental regimen.
---------------------------------------------------------------------------

Given the limitations of the current peer-reviewed scientific
literature on cancer and 9/11 exposures, the Administrator agrees with
the approaches the STAC used to recommend cancers for addition to the
List of WTC-Related Health Conditions, but seeks additional information
or published studies that are informative on the subject of adding
certain types of cancer to the List of WTC-Related Health Conditions
(Section III.D.5).
First, the STAC approach recommended including types of cancer for
which IARC has categorized known 9/11 agents as having sufficient
(Group 1 carcinogens) or limited (Group 2A probable carcinogens and
Group 2B possible carcinogens) evidence for human carcinogenicity. IARC
describes the evidence for carcinogenicity in humans as sufficient when
a causal relationship has been established between exposure to the
agent and human cancer. That is, a positive relationship has been
observed between the exposure and a type of cancer in studies in which
chance, bias, and confounding could be ruled out with reasonable
confidence. IARC describes the evidence as limited when a positive
association has been observed between the exposure and the cancer, and
the IARC working group considered a causal interpretation to be
credible but could not rule out chance, bias, or confounding with
reasonable confidence. The Administrator has made the judgment that an
IARC determination that the epidemiologic evidence for a 9/11 agent is
sufficient or limited for a type of cancer qualifies the type for
inclusion in the List of WTC-Related Health Conditions. The
Administrator has further determined that evidence of exposure to 9/11
agents at any of the three sites--the New York City disaster area, the
Pentagon, or Shanksville, Pennsylvania--qualifies for proposing the
inclusion of a cancer type. The Administrator has also determined that
cancers at sites in close anatomical proximity to sites proposed for
inclusion under Method 3 (described in III.D.3., below) may also be
added since it is often difficult to distinguish the cancer's
anatomical origin especially when cancers from closely proximate sites
are histopathologically indistinguishable.
Second, the STAC drew attention to types of cancers which arise in
regions of the respiratory and digestive tracts where inflammatory
conditions have been documented, some of which are health conditions
already on the List of WTC-Related Health Conditions, including WTC-
related health conditions of the upper and lower airway, and
gastroesophageal reflux disease (GERD). The STAC cited several peer-
review scientific publications about current scientific thinking on the
relationship between inflammation and cancer.
The Administrator agrees that a type of cancer may be added to the
List if there is well-established scientific support for a causal
relationship between that cancer and a WTC-related health condition
already on the List. For example, when a WTC-related health condition
(e.g., GERD) has been determined to be causally associated by means of
multiple epidemiologic studies with the development of a particular
type of cancer (e.g., esophageal cancer), the cancer type can be added
to the List of WTC-Related Health Conditions.
Third, the STAC included types of cancer based on an epidemiologic
cohort study that identified a modest effect of WTC exposure for all
cancers combined in exposed FDNY firefighters. [Zeig-Owens, et al.
2011] The STAC reviewed the Zeig-Owens study, which reported a 32
percent increase in the incidence of cancer among 9/11-exposed
firefighters compared with non-exposed firefighters (Standardized
Incidence Ratio (SIR) 1.32; 95% Confidence Interval (CI) 1.07-1.62).
After correcting for possible surveillance bias, the increase was
reduced to 21 percent (SIR 1.21; 95% CI 0.98-1.49). [Zeig-Owens, et al.
2011]
The Administrator believes that it is plausible that the overall
rate of cancer cases in FDNY firefighters may have increased following
those firefighters' exposures to 9/11 agents, but agrees with the
authors of the Zeig-Owens study who noted there could be other
explanations for the findings:

We remain cautious in our interpretation of these findings
because the time interval since 9/11 is short for cancer outcomes,
the recorded excess of cancers is not limited to specific sites, and
the biological plausibility of chronic inflammation as a possible
mediator between WTC-exposure and cancer outcomes remains
speculative. [Zeig-Owens, et al. 2011]

The Administrator notes that the STAC recommended inclusion of five
site-specific cancer types based on findings in the Zeig-Owens study
when the incidence of certain types of cancer in exposed firefighters
was compared to non-exposed firefighters. These cancers are stomach,
colon (excluding rectum), melanoma, non-Hodgkin lymphoma, and thyroid.
The Zeig-Owens study is

[[Page 35580]]

the only published study of a 9/11-exposed population currently
available for review and presents the risk estimates in multiple ways.
The Administrator agrees with the authors of the Zeig-Owens study, who
note that ``[s]ite-specific cancer SIR ratios (exposed versus non-
exposed) were not significantly increased, although we noted a trend
towards an increase in ten of 15 sites.'' [Zeig-Owens, et al., 2011]
The Administrator placed a different emphasis on an interpretation of
the statistical significance of the findings than did the STAC, and
considered only the cancer risk estimates that were corrected for
surveillance bias and that utilized the more similar referent group,
unexposed firefighters. The Administrator has made the judgment that
only statistically significant findings will be used to support the
proposed inclusion of a type of cancer using Method 1, however cancers
can be added under Methods 2, 3, 4 (see III.D.3., below). At the same
time, the Administrator understands the interpretation of the findings
from the Zeig-Owens study about site-specific cancer rates used by the
STAC to recommend that stomach, colon (excluding rectum), melanoma,
non-Hodgkin lymphoma, and thyroid be included on the List of WTC-
Related Health Conditions.
Fourth, the STAC also considered findings from sources of
information relevant to 9/11 exposures (including the expert judgment
and personal experiences of STAC members, and comments from the public)
and the potential occurrence of cancer.
The Administrator considered the approaches used in the First
Periodic Review and also the approaches used by the STAC to evaluate
the available scientific evidence. In order to determine whether to
propose a type of cancer for inclusion on the List, the Administrator
sought to develop a method that would assist with characterizing 9/11
exposures and the likelihood of developing cancer or a type of cancer.
One approach considered was to rely exclusively on a weight of evidence
evaluation of the epidemiologic literature. In this approach,
accumulated evidence from four types of studies (i.e., cohort, cross
sectional, case-control, and case series) would be evaluated to develop
insight into historic exposures and the risk of developing cancer or a
type of cancer. Utilization of this approach would be consistent with
the approach described by the Administrator in the First Periodic
Review of cancer, a portion of the methodology adopted by the STAC, and
Method 1 described in section III.D.3., below. However, evaluation of
the epidemiologic literature is limited by both the lack of exposure
data available for the days immediately after the collapse of the WTC
Towers and the insufficient time for differences in cancer incidence
and mortality to be detected in 9/11-exposed populations. Additional
approaches were adopted to compensate for both of these limitations.
Method 2 recognizes that certain WTC-related health conditions may
progress to cancer. Method 3 is a qualitative approach that uses
concordance between two authoritative reviews of peer-reviewed
literature (NTP and IARC) as a threshold to characterize the likelihood
of 9/11 agents to cause cancer in humans. Method 4 relies on the work
of the STAC in providing a reasonable basis for adding a type of cancer
in addition to those identified under Methods 1-3.
3. Methods Used by the Administrator To Determine Whether To Add Cancer
or Types of Cancer to the List of WTC-Related Health Conditions
The Administrator developed the following hierarchy of methods for
determining whether to add cancer or types of cancer to the List of
WTC-Related Health Conditions in 42 CFR 88.1. In determining whether to
propose that a type of a cancer be included on the List, a review of
the evidence must demonstrate fulfillment of at least one of the
following four methods:

[ssquf] Method 1. Epidemiologic Studies of September 11, 2001
Exposed Populations. A type of cancer may be added to the List if
published, peer-reviewed epidemiologic evidence supports a causal
association between 9/11 exposures and the cancer type. The
following criteria extrapolated from the Bradford Hill criteria will
be used to evaluate the evidence of the exposure-cancer
relationship:
strength of the association between a 9/11 exposure and
a health effect (including the magnitude of the effect and
statistical significance);
consistency of the findings across multiple studies;
biological gradient, or dose-response relationships
between 9/11 exposures and the cancer type; and
plausibility and coherence with known facts about the
biology of the cancer type. If only a single published epidemiologic
study is available for review, the consistency of findings cannot be
evaluated and strength of association will necessarily place greater
emphasis on statistical significance than on the magnitude of the
effect.
[ssquf] 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 epidemiologic studies for a
causal association between that cancer and a condition already on
the List of WTC-Related Health Conditions.
[ssquf] Method 3. Review of Evaluations of Carcinogenicity in
Humans. A type of cancer may be added to the List only if both of
the following criteria for Method 3 are satisfied:
3A. Published Exposure Assessment Information. 9/11 agents were
reported in a published, peer-reviewed exposure assessment study of
responders or survivors who were present in either the New York City
disaster area as defined in 42 CFR 88.1, or at the Pentagon, or in
Shanksville, Pennsylvania; and
3B. Evaluation of Carcinogenicity in Humans from Scientific
Studies. NTP has determined that the 9/11 agent is known to be a
human carcinogen or is reasonably anticipated to be a human
carcinogen, and IARC has determined there is sufficient or limited
evidence that the 9/11 agent causes a type of cancer.
[ssquf] Method 4. Review of Information Provided by the WTC
Health Program Scientific/Technical Advisory Committee. A type of
cancer may be added to the List if the STAC has provided a
reasonable basis for adding a type of cancer and the basis for
inclusion does not meet the criteria for Method 1, Method 2, or
Method 3.

The Administrator invites comment on this methodology and its
implementation. The following schematic illustrates the methodology
used in this rulemaking.
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4. Administrator's Determination Concerning Petition 001
Using the evidentiary standards established above for inclusion of
a cancer on the List of WTC-Related Health Conditions in 42 CFR 88.1,
the Administrator reviewed the scientific evidence referenced in the
First Periodic Review [NIOSH 2011], Petition 001, and in the STAC's
April 2, 2012 recommendations to the Administrator.\10\ Accordingly,
the Administrator proposes to add the specific types of cancers in
Table A, below, to the List of WTC-Related Health Conditions in 42 CFR
88.1.
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\10\ Transcripts and recordings of the STAC meetings are
available in NIOSH Docket 248 https://www.cdc.gov/niosh/docket/archive/docket248.html. Accessed April 20, 2012.
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5. Explanations for Adding Certain Types of Cancer to the List of WTC-
Related Health Conditions
The Administrator's rationale and the method relied upon for
inclusion of each type of cancer are offered below. The types of cancer
proposed by the Administrator are grouped by anatomical region, for
ease of discussion, and are identified by their individual ICD-10
code.\11\ [WHO 1997] The ICD-9 codes associated with each specific type
of cancer are identified in the regulatory text.
---------------------------------------------------------------------------

\11\ The International Classification of Diseases (ICD) is used
to code and classify injuries and diseases and their signs,
symptoms, and external causes for statistical presentation, disease
analysis, hospital records indexing, and medical billing
reimbursement.
---------------------------------------------------------------------------

Cancers of the Head and Neck. For the reasons discussed below for
each type, the Administrator proposes the inclusion of cancers found in
the lip, tongue, salivary gland, floor of mouth, gum and other mouth,
tonsil, oropharynx, nasopharynx, hypopharynx, other oral cavity and
pharynx, nasal cavity, accessory sinuses, and the larynx.
[ssquf] Malignant neoplasms of the lip [C00], tongue [C01, C02],
salivary gland [C07, C08], floor of mouth [C04], gum and other mouth
[C03, C05, C06], tonsil [C09], oropharynx [C10], hypopharynx [C12,
C13], other oral cavity and pharynx [C14]: (Method 3) IARC has
determined that there is limited evidence that asbestos causes cancer
of other oral cavity and pharynx. The review of published exposure
assessment studies has not identified any 9/11 exposure agent
associated with cancers of the lip, tongue, salivary gland, floor of
mouth, gum and other mouth, tonsil, oropharynx, and hypopharynx. The
Administrator has determined that the types of cancer proposed to be
added in the Head and Neck group under Method 3 share an anatomic
continuum and can be included with other head and neck group types of
cancer.
[ssquf] Malignant neoplasm of the nasopharynx [C11]: (Method 3) The
review of published exposure assessment studies identified formaldehyde
as present in the New York City disaster area. [COPC 2003] IARC has
determined that results of epidemiologic studies of exposure by
inhalation to formaldehyde provide sufficient epidemiological evidence
that formaldehyde causes nasopharyngeal cancer in humans. [IARC 2012c]
[ssquf] Malignant neoplasms of the nasal cavity [C30] and accessory
sinuses [C31]: (Method 3) The review of published exposure assessment
studies identified nickel and hexavalent chromium compounds as present
in the New York City disaster area. [Lioy, et al. 2002; COPC 2003;
Lorber, et al. 2007] IARC has determined that results of epidemiologic
studies of exposure by inhalation provide sufficient epidemiological
evidence that nickel compounds cause cancer of the nose and nasal
sinuses in humans. [IARC 2012a]
[ssquf] Malignant neoplasm of the larynx [C32]: (Method 3) The
review of published exposure assessment studies identified asbestos and
sulfuric acid as present in the New York City disaster area. [Lioy, et
al. 2002; COPC 2003; Lorber, et al. 2007] IARC has determined that
results of epidemiologic studies of exposure by inhalation provide
sufficient epidemiological evidence that all forms of asbestos
(chrysotile, crocidolite, amosite, tremolite, actinolite, and
anthophyllite) cause cancer of the larynx in humans. [IARC 2012a] IARC
has determined that the results of epidemiologic studies of exposure by
inhalation provide sufficient epidemiological evidence that strong
inorganic acids including sulfuric acid cause cancer of the larynx.
Cancers of the Digestive System. For the reasons discussed below
for each site, the Administrator proposes the inclusion of cancers
found in the esophagus; stomach; colon and rectum; liver and
intrahepatic bile duct; retroperitoneum; and peritoneum.
[ssquf] Malignant neoplasms of the esophagus [C15]: (Method 2)
There is well-accepted evidence that symptoms of an already-covered
WTC-related health condition--gastroesophageal reflux disease (GERD)--
increases the risk of developing esophageal cancer. Persons with
recurring symptoms of reflux have an eightfold increase in the risk of
esophageal adenocarcinoma. [Lagergren, et al., 1999]
[ssquf] Malignant neoplasm of the stomach [C16]: (Method 3) The
review of published exposure studies identified asbestos and inorganic
compounds of lead as present in the New York City disaster area. [COPC
2003] IARC has determined that the results of epidemiologic studies of
exposure by inhalation and/or ingestion provide limited evidence that
all forms of asbestos (chrysotile, crocidolite, amosite, tremolite,
actinolite, and anthophyllite) cause cancer of the stomach in humans.
[IARC 2012a] IARC has also determined that there is limited evidence
that exposure to inorganic lead causes cancer of the stomach.
[Cogliano, et al. 2011; IARC 2006]
[ssquf] Malignant neoplasms of the colon (and rectum) [C18, C19,
C20, C26.0]: (Method 3) The review of published exposure assessment
studies identified asbestos as present in the New York City disaster
area. [COPC 2003] IARC has determined that the results of epidemiologic
studies of exposure by inhalation provide limited epidemiologic
evidence that all forms of asbestos (chrysotile, crocidolite, amosite,
tremolite, actinolite, and anthophyllite) cause cancer of the colon and
rectum in humans. [Cogliano, et al. 2011]
[ssquf] Malignant neoplasms of the liver and intrahepatic bile duct
[C22]: (Method 3) The review of published exposure assessment studies
identified vinyl chloride, arsenic and inorganic arsenic compounds,
polychlorinated biphenyls, and trichloroethylene as present in the New
York City disaster area. [COPC 2003] Arsenic and vinyl chloride are
classified as known human carcinogens by IARC and NTP. For arsenic,
IARC identifies the evidence for causality of cancer of the liver and
intrahepatic duct as limited and classifies the evidence for
carcinogenicity of vinyl chloride as sufficient to cause angiosarcomas
of the liver and hepatocellular carcinomas. For polychlorinated
biphenyls and trichloroethylene exposure, IARC characterizes the
evidence as limited for causation of cancer of the liver. [Cogliano, et
al. 2011]
[ssquf] Malignant neoplasms of the retroperitoneum and peritoneum
[C48]: The review of published exposure assessment studies has not
associated any 9/11 agent with cancer of the retroperitoneum,
peritoneum, omentum, and mesentery. The Administrator has determined
that the types of cancer proposed to be added in the digestive system
under Method 3 share an anatomic continuum and can be included together
with other added digestive system types of cancer.
Cancers of the Respiratory System. For the reasons discussed below
for each site, the Administrator proposes the inclusion of cancers
found in the trachea; bronchus and lung; heart; and other and ill-
defined sites in the respiratory system and intrathoracic organs.
[ssquf] Malignant neoplasms of the trachea [C33]; bronchus and lung
[C34]; heart, mediastinum and pleura [C38]; and other ill-defined sites
in the respiratory system and intrathoracic organs [C39]: (Method 3)
The review of published exposure assessment studies identified arsenic,
asbestos, beryllium, cadmium, nickel, and silica as present in the New
York City disaster area. [COPC 2003;

[[Page 35590]]

Lioy, et al. 2002; Wallingford and Snyder 2001] IARC has determined
that there is sufficient evidence in humans for the carcinogenicity of
mixed exposure to inorganic arsenic compounds, including arsenic
trioxide, arsenite, and arsenate. Inorganic arsenic compounds,
including arsenic trioxide, arsenite, and arsenate, cause cancer of the
lung and intrathoracic organs. [IARC 2012a] IARC has determined that
there is sufficient evidence in humans that inhalation exposure to all
forms of asbestos (chrysotile, crocidolite, amosite, tremolite,
actinolite, and anthophyllite) causes cancer of the lung and
intrathoracic organs (including C33, C34, C38, and C39). IARC has
determined that results of epidemiologic studies of exposure by
inhalation provide sufficient epidemiological evidence that beryllium
and beryllium compounds cause cancer of the lung and intrathoracic
organs. [IARC 2012a] IARC has determined that results of epidemiologic
studies of exposure by inhalation provide sufficient epidemiologic
evidence that cadmium and cadmium compounds cause cancer of the lung
and intrathoracic organs in humans. [Cogliano, et al. 2011; IARC 2012a]
IARC has determined that results of epidemiologic studies of exposure
by inhalation provide sufficient epidemiologic evidence that nickel
compounds and nickel metal cause cancer of the lung and intrathoracic
organs in humans. [Cogliano, et al. 2011; IARC 2012a] IARC has
determined that results of epidemiologic studies of exposure by
inhalation provide sufficient epidemiologic evidence that crystalline
silica in the form of quartz causes cancer of the lung and
intrathoracic organs in humans. IARC has also determined that there is
sufficient evidence in humans that soot causes cancer of the lung.
[IARC 2012c] In addition, IARC has determined that strong inorganic
acids, welding fumes, diesel exhaust and 2,3,7,8-tetrachlorodibenzo-
para-dioxin have limited evidence for causing cancer of the respiratory
system.
Cancer of the Mesothelium. For the reasons discussed below, the
Administrator proposes the inclusion of cancer found in the
mesothelium.
[ssquf] Mesothelioma [C45]: (Method 3) The review of published
exposure assessment studies identified asbestos as present in the New
York City disaster area. [Lioy, et al. 2002; COPC 2003; Lorber, et al.
2007] IARC has determined that results of epidemiologic studies of
exposure by inhalation provide sufficient epidemiologic evidence that
all forms of asbestos (chrysotile, crocidolite, amosite, tremolite,
actinolite, and anthophyllite) cause mesothelioma in humans. [IARC
2012a]
Cancer of the Soft Tissues. For the reasons discussed below, the
Administrator proposes the inclusion of cancer found in the soft
tissues.
[ssquf] Malignant neoplasm of peripheral nerves and autonomic
nervous system [C47) and malignant neoplasm of other connective and
soft tissue [C49]: (Method 3) The review of published exposure
assessment studies identified 2,3,7,8-tetrachlorodibenzo-para-dioxin as
present in the New York City disaster area. [COPC 2003] IARC has found
limited evidence for increased risk of soft tissue sarcoma associated
with exposure to 2,3,7,8-tetrachlorodibenzo-para-dioxin.
Cancer of the Skin (non-melanoma and melanoma), including scrotum.
For the reasons discussed below, the Administrator proposes the
inclusion of cancer found in the skin.
[ssquf] Other malignant neoplasms of skin (non-melanoma) [C44],
malignant melanoma of skin [C43], and malignant neoplasm of scrotum
[C63.2]: (Method 3 and 4) The review of published exposure assessment
studies identified arsenic and soot as present in the New York City
disaster area [COPC 2033). Both NTP and IARC determined that arsenic
[IARC 2012c] and occupational exposure to soot [IARC 2012c] are known
human carcinogens and that there is sufficient evidence that they cause
non-melanoma skin cancer.
The STAC recommended including melanoma based on its interpretation
of the Zeig-Owens study. The STAC stated:

the Zeig-Owens study found a statistically significant increase in
melanoma among exposed firefighters compared to the general
population; the Standardized Incidence Ratio (SIR) was slightly
larger but not significant when compared to non-exposed
firefighters. No adjustment for surveillance bias was reported for
malignant melanoma, although early detection through medical
surveillance is likely.

Because the Zeig-Owens finding for melanoma was not statistically
significant (when compared to non-exposed firefighters), the
Administrator cannot propose to add melanoma to the List of WTC-Related
Health Conditions based on Method 1. Melanoma is proposed for inclusion
based on Method 4. The Administrator will continue to monitor cohort
studies that address site-specific cancers such as melanoma in 9/11-
exposed populations.
Cancer of the Breast. For the reasons discussed below, the
Administrator proposes the inclusion of cancer found in the breast.
[ssquf] Malignant neoplasm of the breast [C50]: (Method 4) The STAC
recommended inclusion of breast cancer based on the professional
judgment and personal experience of STAC members and on public
comments. The STAC stated

There is evidence of PCB exposures to WTC responders and
survivors based on air samples, window film samples and one
biomonitoring study. Studies have linked total and congener-specific
PCB levels in serum and adipose tissue with breast cancer, although
evidence has been conflicting. PCBs and some other substances at the
WTC site are endocrine disruptors. Breast cancer risks are highly
related to hormonal factors, including endogenous and exogenous
estrogens, and could plausibly be affected by endocrine disruptors.
A recent study found that PCBs enhanced the metastatic properties of
breast cancer cells by activating rho-associated kinase. Shiftwork
involving circadian rhythm disruption has been classified by IARC as
probably carcinogenic to humans, based in part on epidemiologic
studies associating shiftwork with increased risks of breast cancer.
Both shiftwork and long shifts were common for workers involved in
rescue, recovery, clean up, restoration and other activities at the
WTC site. [STAC 2012, references omitted]

The STAC further noted the lack of opportunity to find evidence for
breast cancer among exposed occupations because so few women work in
the occupations mainly involved with response work in the New York City
disaster area, at the Pentagon, and in Shanksville, Pennsylvania.
Shiftwork has been classified by IARC as probably carcinogenic
based in part on limited evidence in humans demonstrating an increased
risk of breast cancer among shift workers. IARC notes that mechanistic
studies suggest that exposure to light at night may increase the risk
of breast cancer by suppressing the normal nocturnal production of
melatonin, which in turn, may alter gene expression in cancer-related
pathways. [Straif, et al. 2007] NTP has not yet examined the evidence
for an association of shiftwork and breast cancer, however, NTP
recently requested comment from the public whether shiftwork involving
light at night should be nominated for possible review for future
editions of the RoC. [NTP 2012] The Administrator is not aware of any
published exposure assessment study of shiftwork and 9/11, although the
Administrator is aware that extended work hours for many responders
occurred at all three 9/11 sites over several months. The Administrator
proposes to add breast cancer to the List of WTC-Related Health
Conditions based on Method 4, and continues to seek information about

[[Page 35591]]

any exposures in the New York City disaster area, at the Pentagon, or
in Shanksville, Pennsylvania that would further support adding breast
cancer to the List of WTC-Related Health Conditions.
Cancer of the Female Reproductive Organs. For the reasons discussed
below, the Administrator proposes the inclusion of cancer found in the
ovary.
[ssquf] Malignant neoplasm of the ovary [C56]: (Method 3) The
review of published exposure assessment studies identified asbestos as
present in the New York City disaster area. [Lioy, et al. 2002; COPC
2003; Lorber, et al. 2007] IARC has determined that results of
epidemiologic studies of exposure by inhalation provide sufficient
epidemiological evidence that all forms of asbestos (chrysotile,
crocidolite, amosite, tremolite, actinolite, and anthophyllite) cause
cancer of the ovary in humans, based on five strongly positive cohort
mortality studies of women with heavy occupational exposure to
asbestos. [IARC 2012a]
Cancers of the Urinary System. For the reasons discussed below, the
Administrator proposes the inclusion of cancer found in the urinary
bladder, kidney, renal pelvis, ureter and other urinary organs.
[ssquf] Malignant neoplasm of the urinary bladder [C67]: (Method 3)
The review of published exposure assessment studies identified arsenic,
inorganic arsenic, diesel exhaust and soot as present in the New York
City disaster area. Both NTP and IARC determined that arsenic is known
to be a human carcinogen [IARC 2012a], and IARC has determined there is
limited evidence that diesel engine exhaust and soot cause cancer of
the urinary bladder.
[ssquf] Malignant neoplasm of the kidney [C64]: (Method 3) The
review of published exposure assessment studies identified arsenic,
inorganic arsenic compounds, and cadmium and cadmium compounds as
present in the New York City disaster area. [COPC 2003] The evidence
for carcinogenicity of inorganic arsenic compounds and cadmium are
categorized as limited by IARC and NTP, which meets the requirements
for inclusion based on Method 3.
[ssquf] Malignant neoplasm of the renal pelvis, ureter and other
urinary organs [C65, C66 and C68]: (Method 3) The Administrator has
determined that the types of cancer proposed to be added in the urinary
system under Method 3 share an anatomic continuum and can be included
together with other added urinary system types of cancer.
Cancer of the Eye and Orbit. For the reasons discussed below, the
Administrator proposes the inclusion of cancer found in the eye and
orbit.
[ssquf] Malignant neoplasm of the eye and orbit [C69]: (Method 4)
Cancers of the eye and eye orbit are not addressed in the only
published epidemiologic study of September 11, 2001 exposed populations
to date (Method 1). The STAC noted that eye irritation from dust was
ubiquitous in the New York City disaster area and postulated an
association between irritation from dust and cancers of the eye and eye
orbit. However, irritation has not been associated with cancers of the
eye and eye orbit in the published literature (Method 2). The STAC also
noted that IARC determined the evidence is sufficient for welding to
cause ocular melanoma by occupational exposure to ultraviolet
radiation. The review of published exposure assessment studies
identified metal cutting as occurring in the New York City disaster
area, but the exposure assessment literature is silent about welding
involving ultraviolet light exposure. The Administrator proposes to add
cancer of the eye and orbit based on Method 4, but seeks information on
welding activities in the New York City disaster area, at the Pentagon,
or in Shanksville, Pennsylvania, including information on the types of
welding, frequency, and locations to better understand the nature of
the exposures that occurred that could further support adding cancer of
the eye and orbit to the List of WTC-Related Health Conditions.
Cancer of the Thyroid. For the reasons discussed below, the
Administrator proposes the inclusion of cancer found in the thyroid.
[ssquf] Malignant neoplasm of thyroid gland [C73]: (Method 3) The
STAC recommended thyroid cancer for inclusion, noting that it has not
been associated with any of the agents known to be present in the New
York City disaster area. The primary evidence that the STAC based its
recommendation for inclusion on was ``an excess in risk [for thyroid
cancer] from the Zeig-Owens study.'' [STAC 2012] Even though the
Administrator views the significance of the Zeig-Owens finding relating
to thyroid cancer differently than does the STAC, the Administrator
proposes to add thyroid cancer to the List of WTC-Related Health
Conditions based on Method 4. The Administrator will continue to
monitor cohort studies that address site-specific cancer in 9/11-
exposed populations.
Cancers of the Blood and Lymphoid Tissue. For the reasons discussed
below for each type, the Administrator proposes adding malignant
neoplasms of the blood and lymphoid tissues, including, but not limited
to, lymphoma, leukemia, and myeloma.
[ssquf] Hodgkin's disease [C81]; follicular [nodular] non-Hodgkin
lymphoma [C82]; diffuse non-Hodgkin lymphoma [C83]; peripheral and
cutaneous T-cell lymphomas [C84]; other and unspecified types of non-
Hodgkin lymphoma [C85]; malignant immunoproliferative diseases [C88];
multiple myeloma and malignant plasma cell neoplasms [C90]; lymphoid
leukemia [C91]; myeloid leukemia [C92]; monocytic leukemia [C93]; other
leukemias of specified cell type [C94]; leukemia of unspecified cell
type [C95]; other and unspecified malignant neoplasms of lymphoid,
hematopoietic and related tissue [C96]: (Method 3) The review of
published exposure assessment studies identified benzene [Lorber, et
al. 2007; Wallingford and Snyder 2001], 1,3-butadiene [Lorber, et al.
2007; Wallingford and Snyder 2001], and formaldehyde [COPC 2003] as
present in the New York City disaster area. IARC determined that there
is sufficient evidence that exposure to 1,3-butadiene causes cancer of
the hematolymphatic organs. IARC considers hematolymphatic cancers
attributable both to leukemia and malignant lymphoma. The IARC working
group recognized that the epidemiological evidence for an association
with specific subtypes of hematolymphatic cancers is weaker, but when
malignant lymphomas and leukemias are distinguished, the evidence is
strongest for leukemia. [IARC, 2012c] IARC also determined that there
is sufficient evidence that exposure to benzene causes acute myeloid
leukemia and acute non-lymphocytic leukemia. [Cogliano, et al. 2011;
IARC 2012c] IARC has determined that results of epidemiological studies
of exposure by inhalation provide sufficient epidemiological evidence
that formaldehyde causes leukemia in humans. [Cogliano, et al. 2011;
IARC 2012c] In addition, IARC has determined that there is limited
evidence in humans that styrene, tetrachloroethylene,
trichloroethylene, and 2,3,7,8-tetrachlorodibenzo-para-dioxin cause
leukemia. For the reasons discussed above, the Administrator intends to
include all hematolymphatic cancers.
Childhood Cancers. (Method 4) The STAC recommended that childhood
cancers be included on the List of WTC-Related Health Conditions based
on the ``unique vulnerability of children to synthetic chemicals'' and
that ``childhood cancers are rare and excess risks are not likely to be
detectable in the small number of children being

[[Page 35592]]

followed in epidemiologic studies.'' [STAC 2012] The STAC defines
childhood cancers as all cancers diagnosed in persons less than 20
years old. The most common types of childhood cancers are
hematopoietic, bone, kidney, sarcomas, eye, and brain cancers.
Childhood cancers involving the blood and lymphoid tissues, kidney,
sarcomas, and eye cancers have already been added to the List and are
described elsewhere in Section III.D.5. The Administrator proposes to
add childhood cancers--any type of cancer occurring in a person less
than 20 years of age--to the List of WTC-Related Health Conditions
based on Method 4. The Administrator will continue to monitor cohort
studies that address site-specific cancer in 9/11-exposed populations
of children less than 20 years of age.
Rare Cancers. (Method 4) The STAC recommended that rare cancers be
included in the List of WTC-Related Health Conditions but noted that
there is no uniform definition a rare cancer. The STAC also recommended
that ``definitions be based on age-specific incidence rates by gender,
decade of age, site and histology. Site/histology combinations to be
considered as unique cancers should be determined a priori in
consultation with appropriate experts.'' The Rare Diseases Act of 2002
defines a rare disease as one affecting ``small patient populations,
typically populations smaller than 200,000 individuals in the United
States.'' \12\ The National Cancer Institute notes that ``there are
some anatomic sites in which cancer rarely occurs.'' [Young, et al.
2007] For a limited population like that of the WTC Health Program,
cancers that are considered rare based on occurrence rates in the U.S.
population will be rare cancers for the 9/11-exposed populations. The
Administrator proposes to add rare cancers--any type of cancer
affecting populations smaller than 200,000 individuals in the United
States, i.e., occurring at an incidence rate less than 0.08 percent of
the U.S. population--to the List of WTC-Related Health Conditions based
on Method 4 and will consult with appropriate experts as recommended by
the STAC. The Administrator also seeks information about rare cancers
from the public.
---------------------------------------------------------------------------

\12\ Rare Diseases Act of 2002 (Pub. L. 107-208), codified in
Title IV, Sec. 404f(c) of the PHS Act (42 U.S.C. 283h(c)).
---------------------------------------------------------------------------

The Administrator will continue to review and evaluate the
scientific evidence available to determine whether these types and any
other types of cancer should be included in the List. These reviews
will be published in the periodic reviews of cancer. Petitions to add
types of cancer may also be filed with the Administrator. In the event
additional studies are published prior to the issuance of a final rule
regarding the subject of this notice of proposed rulemaking, the
Administrator will consider those studies as appropriate in the process
of developing a final rule.
6. Certification and Treatment of WTC-Related Health Conditions
Including Types of Cancer
In order for an individual enrolled as a WTC responder or survivor
to obtain coverage for treatment of any health condition on the List of
WTC-Related Health Conditions, including any of type of cancer added to
the List, a two-step process must be satisfied. First, a physician at a
Clinical Center of Excellence or in the nationwide provider network
must make a determination that the particular type of cancer for which
the responder or survivor seeks treatment coverage is both: (1) On the
List of WTC-Related Health Conditions; and that (2) exposure to
airborne toxins, other hazards, or adverse conditions resulting from
the September 11, 2001, terrorist attacks is substantially likely to be
a significant factor in aggravating, contributing to, or causing the
type of cancer for which the responder or survivor seeks treatment
coverage.\13\ Pursuant to 42 CFR 88.12(a), the physician's
determination must be based on: (1) An assessment of the individual's
exposure to airborne toxins, any other hazard, or any other adverse
condition resulting from the September 11, 2001, attacks; and (2) the
type of symptoms reported and the temporal sequence of those symptoms.
As a second statutory requirement, all physician determinations are
reviewed by the Administrator and, if found to satisfactorily meet the
exposure assessment and symptom requirements, are certified for
treatment coverage. Thus, inclusion of a condition on the List of WTC-
Related Health Conditions, in and of itself, does not guarantee that a
particular individual's condition will be certified as eligible for
treatment. Responders and survivors denied certification have a right
to appeal the denial of certification.
---------------------------------------------------------------------------

\13\ See Sec. 3312(a)(1), Title XXXIII of the PHS Act; 42
U.S.C. 300mm-22(a)(1).
---------------------------------------------------------------------------

Early detection of cancer in 9/11-exposed populations--either as
part of medical monitoring of enrolled WTC responders and survivors or
part of ongoing research--is an important adjunct to the WTC Health
Program. Screening for the cancers proposed by this rulemaking follow
U.S. Preventive Services Task Force (USPSTF) Guidelines. There are two
types of cancer proposed to be added to the List of WTC-Related Health
Conditions for which the USPSTF has a current recommendation for
screening. The USPSTF recommends screening for colorectal cancer
(cancer of the colon and rectum) using fecal occult blood testing,
sigmoidoscopy, or colonoscopy, in adults, beginning at age 50 years and
continuing until age 75 years. [USPSTF 2008] The Task Force also
recommends breast cancer screening using biennial mammography for women
beginning at age 40.\14\
---------------------------------------------------------------------------

\14\ The Department of Health and Human Services, in
implementing the Affordable Care Act under the standard it sets out
in revised Sec. 2713(a)(5) of the Public Health Service Act,
utilizes the 2002 recommendation on breast cancer screening of the
USPSTF. Available at https://www.uspreventiveservicestaskforce.org/uspstf/uspsbrca2002.htm. Accessed June 7, 2012.
---------------------------------------------------------------------------

7. Endnotes
American Cancer Society [2012] Cancer Facts & Figures 2012. American
Cancer Society, Atlanta, GA. Available at https://www.cancer.org/Research/CancerFactsFigures/CancerFactsFigures/cancer-facts-figures-2012.
Cogliano VJ, Baan R, Straif K, Grosse Y, Lauby-Secretan B, El
Ghissassi F, Bouvard B, Benbrahim-Tallaa L, Guha N, Freeman C,
Galichet L, Wild CP [2011]. Preventable Exposures Associated with
Human Cancers. J Natl Cancer Inst 103:1827-1839.
COPC (Contaminants of Potential Concern) Committee [2003]. World
Trade Center Indoor Environment Assessment: Selecting Contaminants
of Potential Concern and Setting Health-Based Benchmarks. https://www.epa.gov/wtc/reports/contaminants_of_concern_benchmark_study.pdf. Accessed April 18, 2011.
Bradford Hill A [1965]. The Environment and Disease: Association or
Causation? Proceedings of the Royal Society of Medicine (May)
58:295-300.
Howard J [2011]. October 5, 2011 Letter from John Howard, MD,
Director, National Institute for Occupational Safety and Health
(NIOSH) to the WTC Health Program Scientific/Technical Advisory
Committee. This letter is included in the docket for this
rulemaking. See http:www.regulations.gov and https://www.cdc.gov/niosh/docket/archive/docket257.html.
IARC (International Agency for Research on Cancer) [1985]. IARC
Monographs on the Evaluation of the Carcinogenic Risk of Chemicals
to Humans: Vol. 35--Polynuclear Aromatic Compounds, Part 4,
Bitumens, Coal-Tars and Derived Products, Shale-Oils and Soots.
IARC, Lyon, France. https://monographs.iarc.fr/ENG/Monographs/vol35/volume35.pdf. Accessed April 9, 2012.
IARC (International Agency for Research on Cancer) [2006]. IARC
Monographs on the Evaluation of the Carcinogenic Risk of

[[Page 35593]]

Chemicals to Humans: Vol. 88--Formaldehyde, 2-Butoxyethanol and 1-
tert-Butoxypropan-2-ol. IARC, Lyon, France. https://monographs.iarc.fr/ENG/Monographs/vol88/index.php. Accessed April 9,
2012.
IARC (International Agency for Research on Cancer) [2008]. IARC
Monographs on the Evaluation of Carcinogenic Risks to Humans: Vol.
97--1,3-Butadiene, Ethylene Oxide and Vinyl Halides (Vinyl Fluoride,
Vinyl Chloride and Vinyl Bromide). IARC, Lyon, France. https://monographs.iarc.fr/ENG/Monographs/vol97/index.php. Accessed April 9,
2012.
IARC (International Agency for Research on Cancer) [2012a]. IARC
Monographs on the Evaluation of Carcinogenic Risks to Humans: Vol.
100--A Review of Human Carcinogens. Part C: Arsenic, Metals, Fibres,
and Dusts. IARC, Lyon, France. https://monographs.iarc.fr/ENG/Monographs/vol100C/index.php. Accessed April 9, 2012.
IARC (International Agency for Research on Cancer) [2012b]. IARC
Monographs on the Evaluation of Carcinogenic Risks to Humans: Vol.
100--A Review of Human Carcinogens. Part D: Radiation. IARC, Lyon,
France. https://monographs.iarc.fr/ENG/Monographs/vol100D/index.php.
Accessed April 9, 2012.
IARC (International Agency for Research on Cancer) [2012c]. IARC
Monographs on the Evaluation of Carcinogenic Risks to Humans: Vol.
100--A Review of Human Carcinogens. Part F: Chemical Agents and
Related Occupations. IARC, Lyon, France. https://monographs.iarc.fr/ENG/Monographs/vol100F/index.php. Accessed April 9, 2012.
Lagergren J, Bergstrom R, Lingren A, Nyren O [1999]. Symptomatic
Gastroesophageal Reflux as a Risk Factor for Esophageal
Adenocarcinoma. New Engl J Med 340(11): 825-831.
Lioy PJ, Weisel CP, Millette JR, Eisenreich S, Vallero D, Offenberg
J, Buckley B, Turpin B, Zhong M, Cohen MD, Prophete C, Yang I,
Stiles R, Chee G, et al. [2002]. Characterization of the Dust/Smoke
Aerosol that Settled East of the World Trade Center (WTC) in Lower
Manhattan after the Collapse of the WTC 11 September 2001. Environ
Health Perspect 110(7):703-714.
Lorber M, Gibb H, Grant L, Pinto J, Pleil J, Cleverly D [2007].
Assessment of Inhalation Exposures and Potential Health Risks to the
General Population that Resulted from the Collapse of the World
Trade Center Towers. Risk Anal 27(5):1203-21.
Maloney CB, Nadler J, King PT, Schumer CE, Gillibrand KE, Rangel CB,
Velazquez NM, Grimm MG, Clarke YD. [2011]. Letter from Congress to
John Howard, MD, Director, National Institute for Occupational
Safety and Health (NIOSH). WTC Health Program Petition 001. Petition
001 is included in the docket for this rulemaking. See
http:www.regulations.gov and https://www.cdc.gov/niosh/docket/archive/docket257.html.
National Toxicology Program (NTP), Department of Health and Human
Services. [2012] Request for Public Comment on Nominations and Call
for Additional Nominations to the Report on Carcinogens. 77 Fed.
Reg. 2728 (January 12, 2012).
NIOSH [2011]. First Periodic Review of Scientific and Medical
Evidence Related to Cancer for the World Trade Center Health
Program. NIOSH Publication No. 2011-197. https://www.cdc.gov/niosh/docs/2011-197/pdfs/2011-197.pdf/. Accessed April 18, 2012.
NTP (National Toxicology Program) [2011]. 12th Report on
Carcinogens. National Toxicology Program, Public Health Service,
U.S. Department of Health and Human Services, Research Triangle
Park, NC. https://ntp-server.niehs.nih.gov/?objectid=72016262-BDB7-CEBA-FA60E922B18C2540. Accessed May 10, 2012.
Parekh P, Semkow T, Husain L, Wozniak G [2002]. Tritium in the World
Trade Center September 11th, 2001 Terrorist Attack: Its possible
sources and fate. Abstr Pap Am Chem Soc 223:026-NUCL.
Pleil JD, Vette AF, Johnson BA, Rappaport SM [2004]. Air Levels of
Carcinogenic Polycyclic Aromatic Hydrocarbons After the World Trade
Center Disaster. Proc Natl Acad Sci USA. 101:11685-11688.
Rare Diseases Act of 2002 (Pub. L. 107-208), codified in Title IV,
Sec. 404f(c) of the PHS Act (42 U.S.C. Sec. 283h(c)).
Young JL, Ward KC, Ries LAG, Chapter 30 in Ries LAG, Young JL, Keel
GE, Eisner MP, Lin YD, Horner M-J (editors). SEER Survival
Monograph: Cancer Survival Among Adults: U.S. Seer Program, 1988-
2001, Patient and Tumor Characteristics. National Cancer Institute,
SEER Program, NIH Pub. No. 07-6215, Bethesda, MD, 2007.
STAC (World Trade Center Health Program Scientific/Technical
Advisory Committee) [2012]. Letter from Elizabeth Ward, Chair to
John Howard, MD, Administrator. This letter is included in the
docket for this rulemaking. See http:www.regulations.gov and https://www.cdc.gov/niosh/docket/archive/docket257.html.
Straif K, Baan R, Grosse Y, Secretan B, El Ghissassi F, Bouvard V,
Altieri, Benbrahim-Tallaa L, Cogliano V [2007]. Carcinogenicity of
Shift-Work, Painting, and Fire-Fighting. Lancet Oncol. Dec 8:1065-
1066.
United States Preventive Services Task Force (USPSTF) [2008].
Screening for Colorectal Cancer. Available at https://www.uspreventiveservicestaskforce.org/uspstf/uspscolo.htm. Accessed
May 28, 2012.
Wallingford KM, Snyder EM [2001]. Occupational Exposures During the
World Trade Center Disaster Response. Toxicol Ind Health 17:247-253.
WHO (World Health Organization) [1978]. International Classification
of Diseases, Ninth Revision. Geneva: World Health Organization.
WHO (World Health Organization) [1997]. International Classification
of Diseases, Tenth Revision. Geneva: World Health Organization.
Zeig-Owens R, Webber MP, Hall CB, Schwartz T, Jaber N, Weakley J,
Rohan TE, Cohen HW, Derman O, Aldrich TK, Kelly K, Prezant DJ
[2011]. Early Assessment of Cancer Outcomes in New York City
Firefighters After the 9/11 Attacks: An Observational Cohort Study.
Lancet. 378(9794):898-905.

E. Effects of Rulemaking on Federal Agencies

Title II of the James Zadroga 9/11 Health and Compensation Act of
2010 (Pub. L. 111-347) reactivated the September 11, 2001 Victim
Compensation Fund (VCF). Administered by the U.S. Department of Justice
(DOJ), the VCF provides compensation to any individual or
representative of a deceased individual who was physically injured or
killed as a result of the September 11, 2001, terrorist attacks or
during the debris removal. Eligibility criteria for compensation by the
VCF include a list of presumptively covered health conditions, which
are physical injuries determined to be WTC-related health conditions by
the WTC Health Program. Pursuant to DOJ regulations, the VCF Special
Master is required to update the list of presumptively covered
conditions when the List of WTC-Related Health Conditions in 42 CFR
88.1 is updated.\15\
---------------------------------------------------------------------------

\15\ 28 CFR 104.21.
---------------------------------------------------------------------------

IV. Summary of Proposed Rule

The proposed rule would amend the definition of ``List of WTC-
Related Health Conditions'' in 42 CFR 88.1, to include the types of
cancer discussed above in section II.D. Table 1 in the regulatory text
describes types of cancers included in 42 CFR 88.1 and identifies each
by ICD-10 code. Because the ICD-10 modification will not be used by the
U.S. healthcare system until October 1, 2014, the corresponding ICD-9
codes for the included cancer types are also provided in Table 1.
The effect of this amendment would be that, for the types of
cancers added, an enrolled WTC responder, certified-eligible survivor,
or screening-eligible survivor may seek certification of a physician's
determination that the September 11, 2001, terrorist attacks were
substantially likely to be a significant factor in aggravating,
contributing to, or causing the individual's cancer. If the condition
is certified by the Administrator, the individual may seek treatment
and monitoring of this condition under the WTC Health Program.

[[Page 35594]]

V. Regulatory Assessment Requirements

A. Executive Order 12866 and Executive Order 13563

Executive Orders 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,
of reducing costs, of harmonizing rules, and of promoting flexibility.
This rule has been determined to be a ``significant regulatory
action,'' under Sec. 3(f) of E.O. 12866. The addition of specific
types of cancer proposed to be added to the List of WTC-Related Health
Conditions by this rule is estimated to cost the WTC Health Program
between $2,124,624 \16\ and $5,019,182 \17\ (see Table 9) for the first
year (2013). Because a portion of responders and survivors are also
covered by private health insurance, employer-provided insurance (such
as FDNY), or Medicare or Medicaid, only a portion of the costs, those
costs representing the uninsured, are societal costs. All other costs
to the WTC Health Program are transfers. After the implementation of
provisions of the Patient Protection and Affordable Care Act (Pub. L.
111-148) on January 1, 2014, all of the costs to the WTC Health Program
will be transfers. Transfers from FY 2013 through FY 2016 are expected
to be between $12,458,535 and $33,308,060 per annum. Accordingly, this
rule has been reviewed by the Office of Management and Budget. The
proposed rule would not interfere with State, local, and Tribal
governments in the exercise of their governmental functions.
---------------------------------------------------------------------------

\16\ Based on a population of 60,000 at the U.S. cancer rate and
discounted at 7 percent.
\17\ Based on a population of 110,000 at 21 percent above the
U.S. cancer rate and discounted at 3 percent.
---------------------------------------------------------------------------

Cost Estimates
The WTC Health Program has, to date, enrolled approximately 55,000
New York City responders and approximately 5,000 survivors, or
approximately 60,000 individuals in total. Of that total population,
approximately 59,000 individuals were participants in previous WTC
medical programs and were `grandfathered' into the WTC Health Program
established by Title XXXIII. These grandfathered members were enrolled
without having to complete a new member application when the WTC Health
Program started on July 1, 2011 and are referred to in the WTC Health
Program regulations in 42 CFR Part 88 as ``currently identified
responders'' and ``currently identified survivors.'' In addition to
those currently identified WTC responders and survivors already
enrolled, the PHS Act \18\ sets a numerical limitation on the number of
eligible members who can enroll in the WTC Health Program beginning
July 1, 2011 at 25,000 new WTC responders and 25,000 new certified-
eligible WTC survivors \19\ (i.e., the statute restricts new
enrollment). Since July 1, 2011, a total of approximately 1,000 new WTC
responders and new WTC survivors have enrolled in the WTC Health
Program, resulting in only a minor impact on the statutory enrollment
limits for new members. For the purpose of calculating a baseline
estimate of cancer prevalence only, HHS assumed that this gradual rate
of enrollment would continue, and that the currently enrolled
population numbers would remain around 55,000 WTC responders and 5,000
WTC survivors. The estimate is further based on the average U.S. cancer
prevalence rate, and 7 percent discount rate.
---------------------------------------------------------------------------

\18\ PHS Act, Title XXXIII Sec. 3311(a)(4)(A) and Sec.
3321(a)(3)(A).
\19\ See 42 CFR 88.8(b) for explanation of a certified-eligible
survivor.
---------------------------------------------------------------------------

As it is not possible to identify an upper bound estimate, HHS has
modeled another possible point on the continuum. For the purpose of
calculating the impact of an increased rate of cancer on the WTC Health
Program, this analysis assumes that the entire statutory cap for new
WTC responders (25,000) and WTC survivors (25,000) will be filled.
Accordingly, this estimate is based on a population of 80,000
responders (55,000 currently identified + 25,000 new) and 30,000
survivors (5,000 currently identified + 25,000 new). The upper cost
estimate also assumes an overall increase in population cancer rates of
21 percent due to 9/11 exposure,\20\ and costs were discounted at 3
percent. The choice of a 21 percent increase in the risk of cancer of
the rate found in the un-exposed population is based on findings
presented in the only published epidemiologic study of September 11,
2001 exposed populations to date. [Zeig-Owens, et al. 2011] Given the
challenges associated with interpreting the Zeig-Owens findings,\21\ we
simply characterize 21 percent as a possible outcome rather than
asserting the probability that 21 percent is a ``likely'' outcome. HHS
invites public comment on alternative approaches to estimating the
costs and benefits described in this rulemaking, considering for
example cancer latency.
---------------------------------------------------------------------------

\20\ Zeig-Owens R, Webber MP, Hall CB, Schwartz T, Jaber N,
Weakley J, Rohan TE, Cohen HW, Derman O, Aldrich TK, Kelly K,
Prezant DJ [2011]. Early Assessment of Cancer Outcomes in New York
City Firefighters After the 9/11 Attacks: An Observational Cohort
Study. Lancet. 378(9794):898-905.
\21\ As Zeig-Owens et al point out, the time interval since 9/11
is short for cancer outcomes, the recorded excess of cancers is not
limited to specific sites, and the biological plausibility of
chronic inflammation as a possible mediator between WTC-exposure and
cancer means that the outcomes remain speculative.
---------------------------------------------------------------------------

HHS acknowledges that some cancer cases are not likely to have been
caused by exposure to 9/11 agents. The certification of individual
cancer diagnoses will be conducted on a case-by-case basis, after
consideration of the individual responder's or survivor's exposure to
9/11 agents and the temporal sequence of symptoms. However, for the
purpose of this analysis, HHS has estimated that all diagnosed cancers
proposed to be added to the List will be certified for treatment by the
WTC Health Program. Finally, because there are no existing data on
cancer rates related to exposure to 9/11 agents at either the Pentagon
or in Shanksville, Pennsylvania, HHS has used only data from studies of
individuals who were responders or survivors in the New York City
disaster area. HHS invites comment on this approach.
Costs of Cancer Treatment
HHS estimated the treatment costs associated with covering the
select types of cancer proposed in this rulemaking using the methods
described below. In the following discussion, the category of ``Head
and Neck'' includes all cancer cases from nasal cavity, nasopharynx,
accessory sinuses, and larynx. The survival rates for all cancers in
the ``Head and Neck'' category were approximated using survival rates
for cancer of the larynx. The category described as ``Lung'' in this
discussion includes cancer of the trachea, bronchus and lung, heart,
mediastinum and pleura, and other sites in the respiratory system and
intrathoracic organs. Treatment costs for all respiratory system
cancers including ``mesothelioma'' were approximated by treatment costs
for lung cancer. Costs of treatment for the ``digestive system'' were
approximated using the costs of gastric cancer; costs for cancer of the
``skin'' were approximated using costs for melanoma of the skin;
``female reproductive organs'' were

[[Page 35595]]

approximated using costs for cancer of the ovary; ``urinary system''
cancer was approximated by costs of urinary bladder cancer; and ``blood
and lymphoid tissue'' cancers were approximated using leukemia and
lymphoma. The costs for cancer identified with the ``endocrine
system,'' the ``soft tissue sarcomas,'' and ``eye/orbit'' were
approximated using costs for treatment of ``other'' tumors. The
``other'' category includes treatments costs from: salivary gland,
nasopharynx, tonsil, small intestine, anus, intrahepatic bile duct,
gallbladder, other biliary, retroperitoneum, peritoneum, other
digestive organs, nose, nasal cavity, middle ear, larynx, pleura,
trachea, mediastinum and other respiratory organs, bones and joints,
soft tissue, other nonepithelial skin, vagina, vulva, other female
genital organs, penis, other male genital organs, ureter, other urinary
organs, eye and orbit, thyroid, other endocrine multiple myeloma, and
miscellaneous.
The WTC Health Program obtained data for the cost of providing
medical treatment for each cancer type. The costs of treatment for each
type of cancer are described in Table 1. The costs of treatment are
divided into three phases: the costs for the first year following
diagnosis, the costs of intervening years or continuing treatment after
the first year, and the costs of treatment for the last year of life.
The first year costs of cancer treatment are higher due to the initial
need for aggressive medical (e.g. radiation, chemotherapy) and surgical
care. The costs during last year of life are often dominated by
increased hospitalization costs.\22\ Therefore, we used three different
treatment phase costs to estimate the costs of treatment to be able to
best estimate costs in conjunction with expected incidence and long-
term survival for each type of cancer.
---------------------------------------------------------------------------

\22\ 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. Journal: J Natl Cancer Inst 100(9):630-41.

Table 1--Average Costs of Treatment, Male and Female
[2011 $]
----------------------------------------------------------------------------------------------------------------
Initial (12 Continuing Last year of life
Category month) (annual) (12 mos.)
----------------------------------------------------------------------------------------------------------------
Head and Neck.......................................... $28,265 $3,136 $47,730
Digestive System....................................... 59,551 2,544 68,242
Respiratory System..................................... 45,493 5,026 65,592
Mesothelium............................................ 45,493 5,026 65,592
Skin................................................... 3,938 1,040 25,351
Female Reproductive Organs............................. 66,527 5,023 64,728
Urinary System......................................... 16,926 3,630 40,905
Blood & Lymphoid Tissue................................ 33,312 5,782 69,070
Endocrine System....................................... 30,859 3,791 58,623
Soft Tissue Sarcomas................................... 30,859 3,791 58,623
Melanoma............................................... 3,938 1,040 25,351
Breast................................................. 15,136 1,550 37,684
Eye/Orbit.............................................. 30,859 3,791 58,623
----------------------------------------------------------------------------------------------------------------
Source: 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. Journal: J Natl Cancer Inst 100(9):630-41.

These cost figures were based on a study of elderly cancer patients
from Surveillance, Epidemiology, and End Results (SEER) program
maintained by the National Cancer Institute, using Medicare files.\23\
The average costs of treatment described above are given in 2011 prices
adjusted using the Medical Consumer Price Index for all urban
consumers.\24\
---------------------------------------------------------------------------

\23\ Surveillance, Epidemiology, and End Results (SEER) Program
(www.seer.cancer.gov) Research Data (1973-2006), National Cancer
Institute, DCCPS, Surveillance Research Program, Surveillance
Systems Branch, released April 2009, based on the November 2008
submission.
\24\ Bureau of Labor Statistics. Consumer Price Index https://research.stlouisfed.org/fred2/series/CPIMEDSL/downloaddata?cid=32419. Accessed April, 23, 2012.
---------------------------------------------------------------------------

Incident Cases of Cancer
HHS 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
for the cancer types proposed to be added to the List of WTC-Related
Health Conditions under this rulemaking. 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. Gender and age (at the time of
exposure) distributions for responders and survivors were assumed to be
the same as current enrollees in the WTC Health Program. According to
WTC Health Program data, males comprise 88 percent of the current
responder enrollees and 50 percent of survivor enrollees. The age
distribution for current enrollees by gender and responder/survivor
status is presented in Table 2.

Table 2--Percentiles of Current Age (on April 11, 2012) for Current Enrollees in the WTC Health Program by
Gender and Responder/Survivor Status
----------------------------------------------------------------------------------------------------------------
Group
Age percentile (years) --------------------------------------------------------------------------------
Min 1 10 30 50 70 90 99 Max
----------------------------------------------------------------------------------------------------------------
Male responders................ 28 32 39 44 49 54 62 74 92
Female responders.............. 28 30 38 44 49 54 62 76 92

[[Page 35596]]

Male survivors................. 12 23 35 46 52 58 67 81 99
Female survivors............... 12 21 38 49 54 60 68 84 95
----------------------------------------------------------------------------------------------------------------

HHS assumed race and ethnic origin distributions for responders and
survivors according to distributions in the WTC Health Registry cohort:
\25\ 57 percent non-Hispanic white, 15 percent non-Hispanic black, 21
percent Hispanic, and 8 percent other race/ethnicity for responders and
50 percent non-Hispanic white, 17 percent non-Hispanic black, 15
percent Hispanic, and 18 percent other race/ethnicity for survivors.
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 (since
rates are currently available through 2008, the rate from 2008 was
applied to 2009 and later).\26\ A life-table analysis program,
LTAS.NET, was used to estimate the expected number of incident cancers
for cancer types proposed to be added.\27\ HHS calculated cancer
incidence rates using data through 2006 from the Surveillance
Epidemiology and End Results (SEER) Program, and estimated rates for
2007-2016.\28\ 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 each cancer
type starting from year 2002, the first full year following the
September 11, 2001, terrorist attacks, to 2016, the last year for which
this Program is authorized.
---------------------------------------------------------------------------

\25\ Jordan HT, Brackbill RM, Cone JE, Debchoudhury I, Farfel
MR, Greene CM, Hadler JL, Kennedy J, Li J, Liff J, Stayner L,
Stellman SD. Mortality Among Survivors of the Sept 11, 2001, Word
Trade Center Disaster: Results from the World Trade Center Health
Registry Cohort. Lancet 2011;378:879-887.
\26\ Centers for Disease Control and Prevention, National Center
for Health Statistics. Compressed Mortality File 1999-2008. CDC
WONDER Online Database, compiled from Compressed Mortality File
1999-2008 Series 20 No. 2N, 2011. Accessed at https://wonder.cdc.gov/cmf-icd10.html 15 February 2012.
\27\ Schubauer-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. American
Journal of Industrial Medicine 54:915-924.
\28\ National Cancer Institute, Surveillance Epidemiology and
End Results (SEER). https://seer.cancer.gov/. Accessed May 27, 2012.
---------------------------------------------------------------------------

Prevalence of Cancer
To determine the potential number of persons in the responder and
survivor populations with cancer, HHS used the number of incident cases
described above for each year starting with 2002, and estimated the
prevalence of cancer using survival rate statistics for each incident
cancer group through 2016.\29\
---------------------------------------------------------------------------

\29\ National Cancer Institute, Surveillance Epidemiology and
End Results (SEER). https://seer.cancer.gov/. Accessed May 27, 2012.
---------------------------------------------------------------------------

Using the incident cases and survival rate statistics for each
cancer type, HHS has estimated the prevalence (number of persons living
with cancer) of cases during the 15 year period (2002-2016) since
September 11, 2001. The resulting table provides for each year from
2002 through 2016, the number of new cases occurring in that year
(incidence), the number of individuals who died from their cancer in
that year, and the number of persons surviving up to 15 years beyond
their first diagnosis with one table for each type of cancer
(prevalence).\30\ For example, in 2002 there are 23.47 projected new
lung cancer cases, which would be listed as incident cases for that
year. The survival rate for lung cancer in the first year of diagnosis
is 40.6 percent.\31\ Therefore the number of deceased persons in 2002
would be 18.78 x (1-0.406) = 11.15. For the lung cancer prevalence
table, in year 2003, the number of incident cases would be 20.88 cases.
In addition to 20.88 newly diagnosed cases in 2003, there would be the
one-year survivors from 2002 which would be 18.78--11.15 (or 18.78 x
0.406) = 7.62 cases. This computation process can be repeated for each
year through year 2016. A portion of the lung cancer prevalence table
is provided in Table 3 as an example.
---------------------------------------------------------------------------

\30\ The 15-year survival limit is imposed based on the analytic
time horizon.
\31\ National Cancer Institute, Surveillance Epidemiology and
End Results (SEER). https://seer.cancer.gov/. Accessed May 27, 2012.
---------------------------------------------------------------------------

Prevalence tables were created for each type of covered cancer and
the results are summarized in Tables 5, and 7. This analysis considers
cancers diagnosed in 2002 through 2016.

Table 3--Example From Prevalence Table for Lung Cancer
[Based on 80,000 responders]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Years since exposure to 9/11 agents Years covered by WTC Health Program
Year ------------------------------------------------------------------------------------------
2002 2003 2012 2013 2014 2015 2016
--------------------------------------------------------------------------------------------------------------------------------------------------------
1 (incidence)................................................ 18.78 20.88 46.53 51.22 56.10 60.69 66.03
2............................................................ ........... 7.62 17.00 18.89 20.79 22.78 24.64
3............................................................ ........... ........... 9.25 10.18 11.30 12.45 13.63
4............................................................ ........... ........... 6.42 7.08 7.79 8.66 9.53
5............................................................ ........... ........... 4.95 5.46 6.02 6.62 7.35
6............................................................ ........... ........... 4.01 4.45 4.90 5.40 5.94
7............................................................ ........... ........... 3.28 3.67 4.07 4.49 4.94
8............................................................ ........... ........... 2.71 3.03 3.38 3.76 4.14
9............................................................ ........... ........... 2.55 2.49 2.78 3.10 3.45

[[Page 35597]]

10........................................................... ........... ........... 2.15 2.38 2.33 2.60 2.90
11........................................................... ........... ........... 1.78 1.98 2.20 2.14 2.40
12........................................................... ........... ........... ........... 1.66 1.84 2.04 1.99
13........................................................... ........... ........... ........... ........... 1.52 1.69 1.88
14........................................................... ........... ........... ........... ........... ........... 1.42 1.58
15........................................................... ........... ........... ........... ........... ........... ........... 1.35
Live cases from previous years............................... ........... ........... 54.11 61.26 68.94 77.16 85.74
Prevalence................................................... 18.78 28.50 100.64 112.48 125.03 137.85 151.78
Last year of life............................................ 11.15 15.46 39.38 43.54 47.87 52.10 56.79
--------------------------------------------------------------------------------------------------------------------------------------------------------

Cost Computation
To compute the costs for each type of cancer, HHS assumes that all
of the individuals who are diagnosed with a cancer type will be
certified by the WTC Health Program for treatment and monitoring
services. The treatment costs for the first year of treatment (Table 1,
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 1 were applied to the number of prevalent cases who had
survived their cancers beyond their year of diagnosis, for each year of
survival (Year 2-15).
Using this procedure, a cost table is constructed for each year
covered by the WTC Health Program. Table 4 provides an illustrative
example for lung cancer. The row for Year 1 is the cost of incident
cases for that year. Rows 2-15 show the cost from continuing care for
persons surviving n-years beyond the year of diagnosis. Finally, the
cost of last year of life treatment is computed by multiplying the cost
for last year of life from Table 1 by the number of persons dying in
that year from that type of cancer.

Table 4--Cost per 80,000 Responders for Lung Cancer, 2011$
----------------------------------------------------------------------------------------------------------------
Years covered by the WTC Health Program
Year ---------------------------------------------------------------------------
2013 2014 2015 2016
----------------------------------------------------------------------------------------------------------------
1................................... $914,986 $1,002,168 $1,084,205 $1,179,677
2................................... 91,825 101,077 110,708 119,770
3................................... 49,469 54,959 60,497 66,261
4................................... 34,408 37,865 42,068 46,306
5................................... 26,537 29,228 32,165 35,735
6................................... 21,624 23,850 26,268 28,908
7................................... 17,840 19,797 21,834 24,048
8................................... 14,727 16,468 18,274 20,155
9................................... 12,080 13,500 15,096 16,751
10.................................. 11,608 11,311 12,641 14,135
11.................................. 9,642 10,706 10,433 11,659
12.................................. 8,032 8,932 9,917 9,664
13.................................. ................. 7,393 8,221 9,128
14.................................. ................. ................. 6,936 7,714
15.................................. ................. ................. ................. 6,571
Prevalent care...................... 1,212,778 1,337,254 1,459,263 1,589,911
Last year of life care.............. 2,762,609 3,037,261 3,305,416 3,603,198
---------------------------------------------------------------------------
Total........................... 3,975,387 4,374,515 4,764,679 5,193,109
----------------------------------------------------------------------------------------------------------------

The sum of the annual costs for the years 2013 through 2016
represents the estimated treatment costs to the WTC Health Program for
coverage of lung cancer for 80,000 responders. The cost projections in
Table 4 are based on an assumed responder population size of 80,000.
The same process described above was applied to the survivor
cohort. Based on the incidence rate expected from the survivor cohort,
prevalence tables were constructed for each covered type of cancer.
The estimated treatment costs for responders and survivors were re-
computed under two assumptions: (1) Assuming the rate of cancer in the
WTC Health Program is equal to the rate of cancer observed in the
general population; and (2) assuming the rate of cancer exceeds the
general population rate by 21 percent due to their exposures in the New
York City disaster area.\32\ HHS is not aware of any other estimates of
excess cancer rates in the 9/11-exposed population in the peer-reviewed
literature.
---------------------------------------------------------------------------

\32\ Zeig-Owens R, Webber MP, Hall CB, Schwartz T, Jaber N,
Weakley J, Rohan TE, Cohen HW, Derman O, Aldrich TK, Kelly K,
Prezant DJ [2011]. Early Assessment of Cancer Outcomes in New York
City Firefighters After the 9/11 Attacks: An Observational Cohort
Study. Lancet. 378(9794):898-905. Limitations of the Zeig-Owens
study include: limited information on specific exposures experienced
by firefighters; short time for follow-up of cancer outcomes;
speculation about the biological plausibility of chronic
inflammation as a possible mediator between WTC-exposure and cancer
outcomes; and potential unmeasured confounders.

---------------------------------------------------------------------------

[[Page 35598]]

A summary of the estimated prevalence at the U.S. population
average for the assumed population of 55,000 responders and 5,000
survivors is provided in Table 5. A summary of the estimated treatment
costs to the WTC Health Program is provided in Table 6.
A summary of the estimated prevalence using cancer rates 21 percent
over the U.S. population average for the increased rate of 80,000
responders and 30,000 survivors is given in Table 7. A summary of the
estimated treatment costs to the WTC Health Program is provided in
Table 8.

Table 5--Estimated Prevalence by Year and Cancer Type Based on 55,000 and 5,000 Responder and Survivor
Population, Respectively and Assuming Cancer Rates at U.S. Population Average
----------------------------------------------------------------------------------------------------------------
Prevalence (incident + live cases)
Cancer type ---------------------------------------------------------------------------
2013 2014 2015 2016
----------------------------------------------------------------------------------------------------------------
Based on 55,000 responder population
----------------------------------------------------------------------------------------------------------------
Head & Neck......................... 89.41 99.20 109.35 119.83
Digestive System.................... 136.54 150.69 165.19 180.38
Respiratory System.................. 77.91 86.61 95.50 105.16
Mesothelioma........................ 1.02 1.12 1.23 1.35
Skin................................ 11.04 12.22 13.43 14.71
Female Reproductive Organs.......... 5.14 5.64 6.14 6.65
Urinary System...................... 108.78 121.39 134.69 148.90
Blood & Lymphoid Tissue............. 119.72 130.72 141.97 153.71
Endocrine System.................... 53.50 58.75 64.05 69.40
Soft Tissue Sarcomas................ 11.02 11.86 12.67 13.47
Melanoma............................ 134.33 149.37 165.05 181.42
Breast.............................. 102.30 113.46 124.91 136.66
Eye/Orbit........................... 3.89 4.29 4.71 5.14
---------------------------------------------------------------------------
Total........................... 854.59 945.32 1,038.88 1,136.78
----------------------------------------------------------------------------------------------------------------
Based on 5,000 survivor population
----------------------------------------------------------------------------------------------------------------
Head & Neck......................... 7.78 7.78 7.78 7.78
Digestive System.................... 15.48 15.48 15.48 15.48
Respiratory System.................. 10.28 10.28 10.28 10.28
Mesothelioma........................ 0.10 0.10 0.10 0.10
Skin................................ 1.13 1.13 1.13 1.13
Female Reproductive Organs.......... 2.58 2.58 2.58 2.58
Urinary System...................... 10.47 10.47 10.47 10.47
Blood & Lymphoid Tissue............. 12.48 12.48 12.48 12.48
Endocrine System.................... 4.29 4.29 4.29 4.29
Soft Tissue Sarcomas................ 0.96 0.96 0.96 0.96
Melanoma............................ 12.21 13.58 15.00 16.49
Breast.............................. 9.30 10.31 11.36 12.42
Eye/Orbit........................... 0.35 0.39 0.43 0.47
---------------------------------------------------------------------------
Total........................... 87.41 89.83 92.33 94.93
----------------------------------------------------------------------------------------------------------------

Table 6--Estimated Treatment Costs by Year and Cancer Type Based on 55,000 and 5,000 Responder and Survivor Population, Respectively and Assuming Cancer
Rates at U.S. Population Average
[2011 $]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cancer type 2013 2014 2015 2016 2013-2016
--------------------------------------------------------------------------------------------------------------------------------------------------------
Based on 55,000 responder population
--------------------------------------------------------------------------------------------------------------------------------------------------------
Head & Neck.............................................. $925,673 $1,007,744 $1,089,966 $1,164,226 $4,187,609
Digestive System......................................... 4,181,699 4,525,672 4,856,402 5,191,940 18,755,713
Respiratory System....................................... 2,832,704 3,117,317 3,395,504 3,701,062 13,046,587
Mesothelioma............................................. 49,088 54,012 58,869 64,417 226,387
Skin..................................................... 18,078 20,075 21,834 23,072 83,059
Female Reproductive Organs............................... 121,957 130,292 137,643 144,194 534,086
Urinary System........................................... 1,278,299 1,398,867 1,521,993 1,642,997 5,842,157
Blood & Lymphoid Tissue.................................. 2,224,916 2,391,015 2,551,304 2,697,317 9,864,552
Endocrine System......................................... 362,248 385,533 408,544 419,353 1,575,678
Soft Tissue Sarcomas..................................... 148,358 158,024 167,208 175,680 649,270
Melanoma................................................. 229,538 249,805 270,744 284,528 1,034,615
Breast................................................... 420,290 453,613 485,454 510,289 1,869,646
Eye/Orbit................................................ 36,018 39,242 42,470 45,255 162,985
----------------------------------------------------------------------------------------------
Total................................................ 12,828,867 13,931,212 15,007,935 16,064,330 57,832,344
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 35599]]

Based on 5,000 survivor population
--------------------------------------------------------------------------------------------------------------------------------------------------------
Head & Neck.............................................. 77,325 82,580 87,736 92,044 339,685
Digestive System......................................... 471,917 502,369 531,352 559,893 2,065,532
Respiratory System....................................... 362,274 389,675 416,326 444,551 1,612,827
Mesothelioma............................................. 4,625 4,974 5,291 5,659 20,549
Skin..................................................... 1,843 2,034 2,196 2,300 8,372
Female Reproductive Organs............................... 58,454 61,173 63,740 65,729 249,097
Urinary System........................................... 119,698 128,808 137,954 146,467 532,927
Blood & Lymphoid Tissue.................................. 229,578 245,051 259,869 272,842 1,007,340
Endocrine System......................................... 60,893 62,633 63,909 64,476 251,910
Soft Tissue Sarcomas..................................... 14,017 14,748 15,415 15,960 60,140
Melanoma................................................. 30,943 32,541 33,962 35,142 132,588
Breast................................................... 230,196 241,382 251,227 258,804 981,609
Eye/Orbit................................................ 3,434 3,642 3,832 3,994 14,903
----------------------------------------------------------------------------------------------
Total................................................ 1,665,197 1,771,611 1,872,809 1,967,862 7,277,478
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total
--------------------------------------------------------------------------------------------------------------------------------------------------------
Head & Neck.............................................. 1,002,998 1,090,324 1,177,702 1,256,270 4,527,294
Digestive System......................................... 4,653,616 5,028,041 5,387,754 5,751,833 20,821,244
Respiratory System....................................... 3,194,979 3,506,992 3,811,830 4,145,613 14,659,414
Mesothelioma............................................. 53,713 58,987 64,160 70,076 246,936
Skin..................................................... 19,921 22,109 24,030 25,371 91,431
Female Reproductive Organs............................... 180,411 191,466 201,383 209,923 783,183
Urinary System........................................... 1,397,997 1,527,675 1,659,948 1,789,465 6,375,084
Blood & Lymphoid Tissue.................................. 2,454,494 2,636,067 2,811,173 2,970,159 10,871,892
Endocrine System......................................... 423,141 448,166 472,452 483,829 1,827,588
Soft Tissue Sarcomas..................................... 162,376 172,772 182,622 191,640 709,410
Melanoma................................................. 260,481 282,346 304,706 319,670 1,167,203
Breast................................................... 650,486 694,995 736,681 769,093 2,851,255
Eye/Orbit................................................ 39,452 42,885 46,302 49,250 177,888
----------------------------------------------------------------------------------------------
Total................................................ 14,494,064 15,702,823 16,880,744 18,032,192 65,109,823
--------------------------------------------------------------------------------------------------------------------------------------------------------

Table 7--Estimated Prevalence by Year and Cancer Type Based on 80,000 and 30,000 Responder and Survivor
Population, Respectively and Assuming Incidence of Cancer is 21% Higher Than the U.S. Population Due to 9/11
Exposure
----------------------------------------------------------------------------------------------------------------
Prevalence (incident + live cases)
Cancer type ---------------------------------------------------------------------------
2013 2014 2015 2016
----------------------------------------------------------------------------------------------------------------
Based on 80,000 responder population
----------------------------------------------------------------------------------------------------------------
Head & Neck......................... 157.36 174.59 192.45 210.91
Digestive System.................... 240.31 265.21 290.74 317.47
Respiratory System.................. 137.12 152.43 168.07 185.08
Mesothelioma........................ 1.79 1.98 2.16 2.38
Skin................................ 19.43 21.50 23.64 25.89
Female Reproductive Organs.......... 9.05 9.92 10.81 11.71
Urinary System...................... 191.45 213.66 237.05 262.06
Blood & Lymphoid Tissue............. 210.70 230.07 249.86 270.52
Endocrine System.................... 94.16 103.40 112.73 122.15
Soft Tissue Sarcomas................ 19.40 20.87 22.29 23.70
Melanoma............................ 236.42 262.90 290.50 319.30
Breast.............................. 180.05 199.69 219.84 240.52
Eye/Orbit........................... 6.85 7.56 8.29 9.05
---------------------------------------------------------------------------
Total........................... 1,504.09 1,663.77 1,828.43 2,000.74
----------------------------------------------------------------------------------------------------------------
Based on 30,000 survivor population
----------------------------------------------------------------------------------------------------------------
Head & Neck......................... 56.51 56.51 56.51 56.51
Digestive System.................... 112.39 112.39 112.39 112.39
Respiratory System.................. 74.61 74.61 74.61 74.61
Mesothelioma........................ 0.70 0.70 0.70 0.70
Skin................................ 8.21 8.21 8.21 8.21

[[Page 35600]]

Female Reproductive Organs.......... 18.73 18.73 18.73 18.73
Urinary System...................... 76.04 76.04 76.04 76.04
Blood & Lymphoid Tissue............. 90.61 90.61 90.61 90.61
Endocrine System.................... 31.11 31.11 31.11 31.11
Soft Tissue Sarcomas................ 6.94 6.94 6.94 6.94
Melanoma............................ 88.66 98.59 108.94 119.74
Breast.............................. 67.52 74.88 82.44 90.20
Eye/Orbit........................... 2.57 2.83 3.11 3.39
---------------------------------------------------------------------------
Total........................... 634.60 652.16 670.34 689.18
----------------------------------------------------------------------------------------------------------------

Table 8--Estimated Treatment Costs by Year and Cancer Type Based on 80,000 and 30,000 Responder and Survivor Population, Respectively and Assuming
Incidence of Cancer Is 21% Higher Than the U.S. Population Due to 9/11 Exposure
[2011 $]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cancer type 2013 2014 2015 2016 2013-2016
--------------------------------------------------------------------------------------------------------------------------------------------------------
Based on 80,000 responder population
--------------------------------------------------------------------------------------------------------------------------------------------------------
Head & Neck.............................................. $1,656,113 $1,802,945 $1,950,049 $2,082,906 $7,492,013
Digestive System......................................... 7,481,440 8,096,839 8,688,544 9,288,852 33,555,675
Respiratory System....................................... 5,067,965 5,577,164 6,074,865 6,621,536 23,341,531
Mesothelioma............................................. 87,823 96,633 105,323 115,248 405,027
Skin..................................................... 32,344 35,916 39,063 41,278 148,600
Female Reproductive Organs............................... 218,192 233,104 246,256 257,976 955,528
Urinary System........................................... 2,286,993 2,502,701 2,722,984 2,939,472 10,452,150
Blood & Lymphoid Tissue.................................. 3,980,577 4,277,744 4,564,514 4,825,745 17,648,581
Endocrine System......................................... 648,095 689,754 730,922 750,261 2,819,031
Soft Tissue Sarcomas..................................... 265,426 282,719 299,150 314,308 1,161,603
Melanoma................................................. 410,664 446,924 484,385 509,047 1,851,021
Breast................................................... 751,937 811,554 868,522 912,953 3,344,966
Eye/Orbit................................................ 64,439 70,208 75,983 80,965 291,595
----------------------------------------------------------------------------------------------
Total................................................ 22,952,009 24,924,205 26,850,560 28,740,547 44,654,652
--------------------------------------------------------------------------------------------------------------------------------------------------------
Based on 30,000 survivor population
--------------------------------------------------------------------------------------------------------------------------------------------------------
Head & Neck.............................................. 467,817 499,610 530,802 556,869 2,055,097
Digestive System......................................... 2,855,098 3,039,331 3,214,682 3,387,354 12,496,466
Respiratory System....................................... 2,191,761 2,357,535 2,518,774 2,689,533 9,757,602
Mesothelioma............................................. 27,979 30,096 32,010 34,239 124,324
Skin..................................................... 11,149 12,304 13,285 13,912 50,650
Female Reproductive Organs............................... 353,646 370,100 385,629 397,662 1,507,036
Urinary System........................................... 724,172 779,285 834,625 886,127 3,224,209
Blood & Lymphoid Tissue.................................. 1,388,944 1,482,561 1,572,207 1,650,695 6,094,408
Endocrine System......................................... 368,403 378,927 386,647 390,079 1,524,055
Soft Tissue Sarcomas..................................... 84,805 89,226 93,258 96,557 363,846
Melanoma................................................. 187,204 196,873 205,471 212,608 802,156
Breast................................................... 1,392,687 1,460,361 1,519,924 1,565,763 5,938,735
Eye/Orbit................................................ 20,776 22,037 23,182 24,166 90,160
----------------------------------------------------------------------------------------------
Total................................................ 4,912,377 5,256,038 5,588,087 5,914,152 21,670,654
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total
--------------------------------------------------------------------------------------------------------------------------------------------------------
Head & Neck.............................................. 2,123,930 2,302,555 2,480,851 2,639,775 9,547,110
Digestive System......................................... 10,336,538 11,136,171 11,903,227 12,676,206 46,052,141
Respiratory System....................................... 7,259,726 7,934,699 8,593,639 9,311,069 33,099,133
Mesothelioma............................................. 115,803 126,729 137,333 149,487 529,350
Skin..................................................... 43,493 48,220 52,348 55,190 199,251
Female Reproductive Organs............................... 571,838 603,204 631,884 655,638 2,462,564
Urinary System........................................... 3,011,165 3,281,986 3,557,609 3,825,599 13,676,358
Blood & Lymphoid Tissue.................................. 5,369,522 5,760,305 6,136,721 6,476,440 23,742,988
Endocrine System......................................... 1,016,497 1,068,681 1,117,568 1,140,340 4,343,086
Soft Tissue Sarcomas..................................... 350,231 371,945 392,408 410,864 1,525,449
Melanoma................................................. 597,868 643,798 689,857 721,654 2,653,177

[[Page 35601]]

Breast................................................... 2,144,624 2,271,916 2,388,445 2,478,716 9,283,702
Eye/Orbit................................................ 85,215 92,244 99,165 105,132 381,756
----------------------------------------------------------------------------------------------
Total................................................ 33,026,449 35,642,452 38,181,054 40,646,111 147,496,066
--------------------------------------------------------------------------------------------------------------------------------------------------------

Summary of Costs and Transfers
Because HHS lacks data to account for either recoupment by health
insurance or workers' compensation insurance or reduction by Medicare/
Medicaid payments, the estimates offered here are reflective of
estimated WTC Health Program costs only. This analysis offers an
assumption about the number of individuals who might enroll in the WTC
Health Program, and estimates the impact of 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 diagnoses of cancers that are WTC-related health
conditions that might result from this action. Those costs were
addressed in the interim final rule that established regulations for
the WTC Health Program (76 FR 38914, July 1, 2011).
Costs and transfers of screening have been added to the summary
estimates. The screening proposed by this rulemaking follows U.S.
Preventive Services Task Force (USPSTF) guidelines.
The USPSTF recommends screening for colorectal cancer (cancer of
the colon and rectum) using fecal occult blood testing (FOBT),
sigmoidoscopy, or colonoscopy, in adults, beginning at age 50 years and
continuing until age 75 years.\33\ The costs and transfers include the
costs of one FOBT for all Program enrollees who are over the age of 50
in 2013, and for those who will reach 50 years of age in 2014 through
2016. In the general population, HHS expects there to be 9 percent
positive tests. In a previous study \34\ of those with positive tests
who were outside the study university system, 44 percent had a
colonoscopy, 42 percent had flexible sigmoidoscopy, 11 percent had
repeat FOBT, and 3 percent were told by their physician that no further
examination was necessary. HHS applied these rates to the population
and assigned costs for each test assuming FOBT cost was $7.60,
sigmoidoscopy was $238, and a colonoscopy was $674.\35\
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\33\ United States Preventive Services Task Force (USPSTF)
[2008]. Screening for Colorectal Cancer. Available at https://www.uspreventiveservicestaskforce.org/uspstf/uspscolo.htm. Accessed
May 28, 2012.
\34\ Mandel JS, et. al, Reducing Mortality From Colorectal
Cancer by Screening for Fecal Occult Blood, NEJM 328(19): 1365-1371
(1993).
\35\ Subramanian S, et. al. When Budgets Are Tight, There Are
Better Options Than Colonoscopies For Colorectal Cancer Screening.
Health Affairs, September 2010, 29:9, 1734-1740.
FECA Rates for FOBT, sigmoidoscopy and colonoscopy at non-
facility rates: codes 82270, 45330, and 45378 respectively.
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The USPSTF recommends breast cancer screening using biennial
mammography for women beginning at age 40. HHS assumed that the
population of responders was 12 percent female and the population of
survivors was 50 percent female. Based on age distribution information
available, HHS estimated the number of women eligible for screening
between 2013 and 2016. For those screened in 2013 HHS predicted repeat
screening in 2015 and for those screened in 2014 HHS predicted repeat
screening in 2016. The cost of a mammogram was estimated at $139.32
based on FECA rates for mammography.\36\
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\36\ FECA rates for Mammography for New York; FECA code 77057.
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Some responders and survivors enrolled or expected to enroll in the
WTC Health Program already have or have access to medical insurance
coverage by private health insurance, employer-provided insurance,
Medicare, or Medicaid. Therefore, costs to the WTC Health Program can
be divided between societal costs and transfer payments.
To describe these societal costs and transfers, the following
assumptions were used. For the period of coverage between January 1,
2013 and December 31, 2013, HHS has assumed that 16.3 percent of the
survivor population will be uninsured, or based on grandfathered
enrollment of responders, 16,925 are covered by the FDNY health plan,
while 39,482 are listed as general responders and include construction
workers, contractors, and others. For this analysis, HHS assumed that
the non-FDNY general responders and all future responder-enrollees are
uninsured at the same 16.3 percent rate that HHS applied to the
survivor population, based on those without insurance coverage in the
general U.S. population.\37\ Ward et al.\38\ found that access to
health care services, quality of care received, stage of disease at
diagnosis, and survival outcomes for cancer patients varied according
to socioeconomic status and demographic characteristics.
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\37\ U.S. Census Bureau [2011]. Current Population Survey.
https://www.census.gov/cps/data/. Accessed May 26, 2012.
\38\ Ward E, Halpern M, Schrag N, Cokkinides V, DeSantis C,
Bandi P, Siegel R, Stewart A, Jemal A [2008]. Association of
Insurance with Cancer Care Utilization and Outcomes. CA Cancer J
Clin 58:9-31.
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Additionally, after the implementation of provisions of the Patient
Protection and Affordable Care Act (Pub. L. 111-148) on January 1,
2014, all of the enrollees and future enrollees can be assumed to have
or have access to medical insurance coverage other than through the WTC
Health Program. Therefore, all treatment costs to be paid by the WTC
Health Program from 2014 through 2016 are considered transfers.
Table 9 describes the allocation of WTC Health Program costs
between societal costs and transfer payments based on 55,000 responders
and 5,000 survivors. Table 10 describes the allocation of WTC Health
Program costs between societal costs and transfer payments based on
80,000 responders and 30,000 survivors.

[[Page 35602]]

Table 9--Breakdown of Estimated Annual WTC Health Program Costs and Transfers, 80,000 & 55,000 Responders and
30,000 and 5,000 survivors, 2013-2016, 2011$
----------------------------------------------------------------------------------------------------------------

----------------------------------------------------------------------------------------------------------------
Societal costs for 2013, 2011$
Annualized transfers for 2013-2016,
2011$
---------------------------------------------------------------------------
Based on the 16.3 percent of general Discounted at 7 Discounted at 3
responders and survivors who are percent percent
expected to be uninsured
---------------------------------------------------------------------------
Cancer rate
Cancer rate
----------------------------------------------------------------------------------------------------------------
U.S. Average U.S. + 21% U.S. Average U.S. + 21%
55,000 Responders................... $1,648,706 ................. $10,172,308 .................
5,000 Survivors..................... 271,427 ................. 1,572,907 .................
Colorectal and Breast Screening..... 204,491 ................. 713,321 .................
----------------------------------------------------------------------------------------------------------------
60,000 Total........................ 2,124,624 ................. 12,458,535 .................
----------------------------------------------------------------------------------------------------------------
80,000 Responders................... ................. $2,631,100 ................. $19,912,464
30,000 Survivors.................... ................. 1,970,560 ................. 12,124,118
Colorectal and Breast Screening..... ................. 417,521 ................. 1,271,478
----------------------------------------------------------------------------------------------------------------
110,000 Total....................... ................. 5,019,182 ................. 33,308,060
----------------------------------------------------------------------------------------------------------------

Examination of Benefits (Health Impact)
This section describes qualitatively the potential benefits of the
proposed rule in terms of the expected improvements in the health and
health-related quality of life of potential cancer patients treated
through the WTC Health Program, compared to no Program. The assessment
of the health benefits for cancer patients uses the number of expected
cancer cases that was estimated in the cost analysis section.
HHS does not have information on the health of the population that
may have been exposed to 9/11 agents and is not currently enrolled in
the WTC Health Program. In addition, HHS has only limited information
about health insurance and health care services for cancers caused by
exposure to 9/11 agents 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, HHS assumes that broad
trends on demographics and access to health insurance reported by the
U.S. Census Bureau and health care services for cancer similar to those
reported by Ward would apply to the population of general responders
(those individuals who are not members of the FDNY and who meet the
eligibility criteria in 42 CFR Part 88 for WTC responders) and
survivors both within and outside the Program. For the purposes of this
analysis, HHS assumes that access to health insurance and health care
services for FDNY responders within and outside the Program would be
equivalent because this population is overwhelmingly covered by
employer-based health insurance.
Although HHS cannot quantify the benefits associated with the WTC
Health Program, enrollees with cancer are expected to experience a
higher quality of care than they would in the absence of the Program.
Mortality and morbidity improvements for cancer patients expected to
enroll in the WTC Health Program are anticipated because barriers may
exist to access and delivery of quality health care services for cancer
patients in the absence of the services provided by the WTC Health
Program. HHS anticipates benefits to cancer patients treated through
the WTC Health Program, who may otherwise not have access to health
care services (16.3 percent of general responders and survivors who are
expected to be uninsured), to accrue in 2013. Starting in 2014,
continued implementation of the Affordable Care Act will result in
increased access to health insurance and health care services will
improve for the general responder and survivor population that
currently is uninsured. HHS is requesting public comment on issues
relating to access to care, quality of care, and the potential benefits
associated with the WTC Health Program.
Limitations
The analysis presented here was limited by the dearth of verifiable
data on the cancer status of responders and survivors who have yet to
apply for enrollment in the WTC Health Program. Because of the limited
data, HHS was not able to estimate benefits in terms of averted
healthcare costs. Nor was HHS 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.
Regulatory Alternatives
As discussed in section III.D.2., above, the Administrator
considered alternative approaches to the methods set forth in this
rulemaking.
One alternative would involve a presumption that 9/11 exposures
could have resulted in the development of any and all types of cancer
in the exposed populations. A presumption that any and all types of
cancer could occur after exposure to 9/11 agents does not require any
scientific evidence of a positive association between exposure and a
type of cancer. The Administrator declined to determine inclusion of
types of cancer based on a presumption approach. The STAC affirmatively
rejected a recommendation to include any and all types of cancer to the
List of WTC-Related Health Conditions. The Administrator made the
policy decision to include only those types of cancer when a positive
relationship has been established between exposure to the 9/11 agent
and human cancer.
Another alternative would be to rely on epidemiologic studies of
the association of 9/11 exposures and the development of cancer or a
type of cancer in 9/11-exposed populations exclusively. There are
several limitations to using an exclusive 9/11 populations study
approach. The Administrator finds that vast uncertainties exist in
conducting epidemiologic studies of cancer in 9/11-exposed populations.
For example, there exists only very limited, individual exposure data
in 9/11-exposed populations. This lack of

[[Page 35603]]

personal, quantitative exposure data impedes the definitive
epidemiologic evidence that exposure to 9/11 agents causes certain
types of cancer in responder and survivor populations. In addition,
cancer is generally a long latency set of diseases which in some cases
may take many years or even decades to manifest clinically. Requiring
evidence of positive associations from studies of 9/11-exposed
populations exclusively does not serve the best interests of WTC Health
Program members.
By expanding the scope of scientific information reviewed to
include three complementary methods (including studies in 9/11 exposed
populations and generally available epidemiologic criteria), the
Administrator has developed a hierarchy of methods to guide
consideration of whether to include types of cancers on the List of
WTC-Related Health Conditions.
Effects on Other Agency Programs
HHS finds that this rulemaking also has an effect on the VCF \39\
administered by DOJ. DOJ administers the VCF under rules promulgated at
28 CFR part 104. The DOJ regulations define, in 28 CFR 104.2 (f), the
term ``WTC-related health condition'' to mean ``those health conditions
identified as WTC-related by Title I of Public Law 111-347 and by
regulations implementing that Title.'' The preamble to the VCF final
rule (76 FR 54115) states, ``If the WTC Health Program determines that
certain forms of cancer should be added to the list of WTC-related
conditions, the final rule requires the Special Master to add such
conditions to the list of presumptively covered conditions for the
Fund.''
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\39\ The September 11th Victim Compensation Fund of 2001 (VCF)
was initially established in 2001 pursuant to Title IV of Public Law
107-42, 115 Stat. 230 (Air Transportation Safety and System
Stabilization Act) and was open for claims from December 21, 2001,
through December 22, 2003. Title II of the Zadroga Act amends and
reactivates the September 11th Victim Compensation Fund of 2001.
Public Law 111-347. Administered through DOJ by a Special Master,
the VCF provides compensation to any individual (or a personal
representative of a deceased individual) who suffered physical harm
or was killed as a result of the terrorist-related aircraft crashes
of September 11, 2001, or the debris removal efforts that took place
in the immediate aftermath of those crashes.
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Under the VCF program, compensation awards are generally calculated
using three components: Economic loss plus non-economic loss minus
collateral source payments. To determine economic loss, the Special
Master considers any prior loss of earnings or other benefits related
to employment, medical expense loss, replacement services loss, and
loss of business or employment opportunity. The regulations provide
presumed non-economic awards for deceased individuals. Because every
physical injury is unique, the Special Master may determine presumed
non-economic losses on a case-by-case basis for physically injured
claimants. The Special Master then subtracts any collateral offsets
received or eligible to be received. The computation of individual
compensation due under the fund is based on factors pertinent to each
individual claimant.
The statute caps the total amount of funds allocated to the VCF.
The VCF regulation at 28 CFR 104.51 provides that, ``the total amount
of Federal funds paid for expenditures including compensation with
respect to claims filed on or after October 3, 2011, will not exceed
$2,775,000,000. Furthermore, the total amount of Federal funds expended
during the period from October 3, 2011, through October 3, 2016, may
not exceed $875,000,000.''
To meet these requirements, the Special Master is authorized to
reduce the amount of compensation due to each claimant by prorating the
total amount of the compensation award determined for each individual
claimant. The VCF intends to establish the fraction for proration such
that all claimants receive some payment related to their claim within
the overall funding limitation of the program. The Special Master may
adjust the percentage of the total award that is to be paid to eligible
claims based on experiential information as well as estimates related
to potential future claims and availability of funds.
The amount of compensation that would be awarded to each of the
living claimants who develop, or the heirs of those who died from, a
covered type of cancer during the years 2002 through 2016, would be
determined by individual factors considered under the VCF. Depending on
the total number of new claims and compensation eligibility, the
overall impact on the VCF of increasing the number of eligible VCF
claimants as a result of adding eligible health condition under the WTC
Health Program may be to reduce the proration fraction that is applied
to all VCF claimants such that the total cost to the government remains
unchanged. The additional costs to the VCF due to processing and
computing the entitlement for the extra claimants eligible as a result
of having a covered type of cancer, plus the costs of paying newly
covered claimants their prorated share of the compensation award, would
result in amounts that will not be available to pay increased shares
for the claimants with non-cancer conditions.

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-for-profit organizations. HHS
believes that this rule has ``no significant economic impact upon a
substantial number of small entities'' within the meaning of the
Regulatory Flexibility Act (5 U.S.C. 601 et seq.).
The WTC Health Program has contracted with the following healthcare
providers and provider network managers to offer treatment and
monitoring to enrolled responders and survivors: Seven Clinical Centers
of Excellence (CCE), which serve responders and survivors in the New
York City metropolitan area (City of New York Fire Department; Mount
Sinai School of Medicine; Research Foundation of State University of
New York; New York University, Bellevue Hospital Center; University of
Medicine and Dentistry of New Jersey; Long Island Jewish Medical
Center; and New York City Health and Hospitals Corporation); Logistics
Health Incorporated, which manages the nationwide provider network for
populations geographically distant from New York City; three Data
Centers, which analyze CCE data and coordinate activities (City of New
York Fire Department; Mount Sinai School of Medicine; and New York City
Health and Hospitals Corporation); and Emdeon, which manages pharmacy
benefits.
Of these entities, six of the seven CCEs and two of the three Data
Centers are hospitals (NAICS 622110--General Medical and Surgical
Hospitals). The Small Business Administration (SBA) identifies as a
small business those hospitals with average annual receipts below $34.5
million; none of the six fall below the SBA threshold for small
businesses. The City of New York Fire Department's Bureau of Health
Services, which provides medical monitoring and treatment for FDNY
members as a CCE, and provides data analysis and other services for the
FDNY CCE as a Data Center, is considered a local government agency
(NAICS 922160--Fire Protection), and as such cannot be considered a
small entity by SBA. Finally, neither Logistics Health Incorporated,
which manages the national provider network, nor Emdeon, which manages
pharmacy benefits, (NAICS 551112--Management of Companies and
Enterprises) falls below

[[Page 35604]]

SBA's $7 million threshold for small businesses in that sector.
Because no small businesses are impacted by this rulemaking, HHS
certifies that this rule will not have a significant economic impact on
a substantial number of small entities within the meaning of the RFA.
Therefore, a regulatory flexibility analysis as provided for under RFA
is not required.

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. 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, 2014).
HHS has determined that no changes are needed to the information
collection request already approved by OMB.

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 by State, local or Tribal governments in the
aggregate, or by the private sector. However, the rule may result in an
increase in the contribution made by New York City for treatment and
monitoring, as required by Title XXXIII, Sec. 3331(d)(2). For 2012,
the inflation adjusted threshold is $139 million.

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 been reviewed carefully
to eliminate drafting errors and ambiguities.

G. Executive Order 13132 (Federalism)

HHS 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, HHS has evaluated the
environmental health and safety effects of this proposed rule on
children. HHS has determined that the rule would have no environmental
health and safety effect on children, although an eligible child who
has been diagnosed with a cancer type specified in this rulemaking may
seek certification of the condition by the Administrator.

I. Executive Order 13211 (Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use)

In accordance with Executive Order 13211, HHS 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. HHS has attempted to use plain
language in promulgating the proposed rule consistent with the Federal
Plain Writing Act guidelines and requests comment from the public
regarding this requirement.

VI. Proposed Rule

List of Subjects in 42 CFR Part 88

Aerodigestive disorders, Appeal procedures, Cancer, Health care,
Mental health conditions, Musculoskeletal disorders, Respiratory and
pulmonary diseases.

For the reasons discussed in the preamble, the Department of Health
and Human Services proposes to amend 42 CFR part 88 as follows:

PART 88--WORLD TRADE CENTER HEALTH PROGRAM

1. The authority citation for Part 88 continues to read as follows:

Authority: 42 U.S.C. 300mm-300mm-61, Pub. L. 111-347, 124 Stat.
3623.

Sec. 88.1 [Amended]

2. Amend Sec. 88.1 by adding paragraph (4) to the definition of
``List of WTC-related health conditions'' to read as follows:

Sec. 88.1 Definitions.

* * * * *
List of WTC-related health conditions * * *
* * * * *
(4) Cancers: This list includes those individual cancer types
specified in Table 1, below, according to the International
Classification of Diseases, 10th Edition (ICD-10) and International
Classification of Diseases, 9th Edition (ICD-9).
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Dated: May 31, 2012.
John 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. 2012-14203 Filed 6-8-12; 4:15 pm]
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