80 FR 54746 - World Trade Center Health Program; Addition of New-Onset Chronic Obstructive Pulmonary Disease and Acute Traumatic Injury to the List of WTC-Related Health Conditions
DEPARTMENT OF HEALTH AND HUMAN SERVICES Federal Register Volume 80, Issue 176 (September 11, 2015)
Federal Register Volume 80, Issue 176 (September 11, 2015)
| Page Range | 54746-54760 | |
| FR Document | 2015-22599 |
[Federal Register Volume 80, Number 176 (Friday, September 11, 2015)] [Proposed Rules] [Pages 54746-54760] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-22599] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES 42 CFR Part 88 [Docket No. CDC-2015-0063, NIOSH-287] RIN 0920-AA61 World Trade Center Health Program; Addition of New-Onset Chronic Obstructive Pulmonary Disease and Acute Traumatic Injury to the List of WTC-Related Health Conditions AGENCY: Centers for Disease Control and Prevention, HHS. ACTION: Notice of proposed rulemaking. ----------------------------------------------------------------------- SUMMARY: The World Trade Center (WTC) Health Program, at the direction of the Administrator, conducted a review of published studies regarding potential evidence of chronic obstructive pulmonary disease (COPD) and acute traumatic injury among individuals who were responders to or survivors of the September 11, 2001, terrorist attacks. The Administrator of the WTC Health Program found that [[Page 54747]] these studies provided substantial support for a causal relationship between the health conditions and 9/11 exposures. As a result, the Administrator has determined to publish a proposed rule to add new- onset COPD and to add acute traumatic injury to the List of WTC-Related Health Conditions eligible for treatment coverage in the WTC Health Program. DATES: Comments must be received by October 26, 2015. ADDRESSES: Written Comments: You may submit comments by any of the following methods:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Mail: NIOSH Docket Office, 1090 Tusculum Avenue, MS C-34, Cincinnati, OH 45226-1998. Instructions: All submissions received must include the agency name (Centers for Disease Control and Prevention, HHS) and docket number (CDC-2015-0063) or Regulation Identifier Number (0920-AA61) for this rulemaking. All relevant comments, including any personal information provided, will be posted without change to http://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 http://www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Rachel Weiss, Program Analyst, 1090 Tusculum Ave, MS: C-46, Cincinnati, OH 45226; telephone (855)818-1629 (this is a toll-free number); email [email protected]. SUPPLEMENTARY INFORMATION: Table of Contents I. Executive Summary A. Purpose of Regulatory Action B. Summary of Major Provisions C. Costs and Benefits II. Public Participation III. Background A. WTC Health Program Statutory Authority B. Methods Used by the Administrator to Determine Whether to Add Non-Cancer Health Conditions to the List of WTC-Related Health Conditions IV. COPD A. CCE and Data Center Request to Consider Adding New-Onset COPD B. Literature Review C. Administrator's Determination Concerning New-Onset COPD V. Acute Traumatic Injury A. CCE and Data Center Request to Consider Adding Acute Traumatic Injury B. Literature Review C. Administrator's Determination Concerning Acute Traumatic Injury VI. Effects of Rulemaking on Federal Agencies VII. Summary of Proposed Rule VIII. 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 I. Executive Summary A. Purpose of Regulatory Action This rulemaking is being conducted in order to add new-onset COPD and acute traumatic injury to the List of WTC-Related Health Conditions (List). Following requests by the directors of the WTC Health Program Clinical Centers of Excellence (CCE) and Data Centers to the WTC Health Program to consider adding the two conditions,\1\ the Administrator conducted literature reviews regarding COPD and acute traumatic injury among 9/11 responders and survivors. Based on the findings of those reviews, he determined that the evidence for causal relationships between 9/11 exposures and COPD and acute traumatic injury, respectively, provides bases for the addition of both health conditions. The Administrator proposes adding new-onset COPD and acute traumatic injury to the List. --------------------------------------------------------------------------- \1\ Crane M, Lucchini R, Moline J, Prezant D, Kelly K, Udasin I, Luft B, Harrison D, Reibman J, Markowitz S [2014]. Letter from CCE and Data Center Directors to Dori Reissman and John Halpin, WTC Health Program regarding ``Musculoskeletal Conditions;'' and Crane M, Lucchini R, Moline J, Prezant D, Kelly K, Udasin I, Luft B, Harrison D, and Reibman J [2014]. Letter from CCE and Data Center Directors to Dori Reissman and John Halpin, WTC Health Program regarding ``Rationale for the continued certification of COPD as a World Trade Center related and covered condition.'' These letters are included in the docket for this rulemaking. --------------------------------------------------------------------------- B. Summary of Major Provisions This rule proposes the addition of new-onset COPD and acute traumatic injury to the List of WTC-Related Health Conditions in 42 CFR 88.1. As a result, these conditions will be eligible for treatment and monitoring coverage by the WTC Health Program. C. Costs and Benefits The proposed addition of new-onset COPD and acute traumatic injury by this rulemaking is estimated to cost the WTC Health Program between $5,124,477 and $9,350,966 in 2015 and 2016. All of the costs to the WTC Health Program are transfers. Benefits to current and future WTC Health Program members may include improved access to care and better treatment outcomes than in the absence of Program coverage. II. Public Participation Interested persons or organizations are invited to participate in this rulemaking by submitting written views, opinions, recommendations, and/or data. Comments are invited on any topic related to this proposed rule. The Administrator invites comments specifically on the following questions related to this rulemaking: 1. Is September 11, 2003 an appropriate deadline by which an individual must have received initial medical treatment for an acute traumatic injury? 2. Is there evidence of acute traumatic injuries that occurred as a result of the September 11, 2001, terrorist attacks that would not be covered by the proposed definition? What are the types of long-term consequences or medically associated health conditions that result from the treatment or progression of acute traumatic injuries like those sustained on or after September 11, 2001? 3. Are data available on the chronic care needs of individuals who suffered acute traumatic injuries during the September 11, 2001, terrorist attacks, and its aftermath that the Administrator can use to estimate the number of current and future WTC Health Program members who may seek certification of WTC-related acute traumatic injuries as well as treatment costs? 4. Are data available on the prevalence and cost estimates for new- onset COPD? 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 submitted electronically or by mail should be titled ``Docket No. CDC-2015-0063'' and should identify the author(s) and contact information 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. [[Page 54748]] The Administrator has determined that good cause exists to extend the traditional 30-day comment period to 45 days. The comment period is extended to provide interested parties, including peer-reviewers, adequate time to review the proposed rule and supporting scientific literature and to submit written comments to the docket. 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 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 (responders), and to eligible persons who were present in the dust or dust cloud on September 11, 2001 or who worked, resided, or attended school, childcare, or adult daycare in the New York City disaster area (survivors). --------------------------------------------------------------------------- \2\ Title XXXIII of the PHS Act is codified at 42 U.S.C. 300mm to 300mm-61. Those portions of the Zadroga Act found in Titles II and III of Public Law 111-347 do not pertain to the WTC Health Program and are codified elsewhere. --------------------------------------------------------------------------- All references to the Administrator of the WTC Health Program (Administrator) in this notice mean the Director of the National Institute for Occupational Safety and Health (NIOSH) or his or her designee. Section 3312(a)(6) of the PHS Act requires the Administrator to conduct rulemaking to propose the addition of a health condition to the List of WTC-Related Health Conditions (List) codified in 42 CFR 88.1. B. Methods Used by the Administrator to Determine Whether to Add Non- Cancer Health Conditions to the List of WTC-Related Health Conditions Consideration of an addition to the List of WTC-Related Health Conditions (List) may be initiated at the Administrator's discretion \3\ or following receipt of a petition by an interested party.\4\ 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)(D) 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. --------------------------------------------------------------------------- \3\ PHS Act, sec. 3312(a)(6)(A); 42 CFR 88.17(b). \4\ PHS Act, sec. 3312(a)(6)(B); 42 CFR 88.17(a). --------------------------------------------------------------------------- The Administrator has established a methodology for evaluating whether to add non-cancer health conditions to the List of WTC-Related Health Conditions; this methodology is published online in the Policies and Procedures section of the WTC Health Program Web site.\5\ The Administrator will direct the WTC Health Program Associate Director for Science (ADS) to conduct a review of the scientific literature to determine if the available scientific information has the potential to provide a basis for a decision on whether to add the condition to the List. The literature review will include published, peer-reviewed direct observational and/or epidemiological studies about the health condition among 9/11-exposed populations. The studies will be reviewed for their relevance, quantity, and quality to provide a basis for deciding whether to propose adding the health condition to the List. Where the available evidence has the potential to provide a basis for a decision, the ADS will further assess the scientific and medical evidence to determine whether a causal relationship between 9/11 exposures and the health condition is supported. A health condition may be added to the List if published, peer-reviewed direct observational or epidemiologic studies provide substantial support \6\ for a causal relationship between 9/11 exposures and the health condition in 9/11- exposed populations. If only epidemiologic studies are available and they provide only modest support \7\ for a causal relationship between 9/11 exposures and the health condition, the Administrator may then evaluate additional published, peer-reviewed epidemiologic studies, conducted among non-9/11-exposed populations, evaluating associations between the health condition of interest and 9/11 agents.\8\ If that additional assessment establishes substantial support for a causal relationship between a 9/11 agent or agents and the health condition, the health condition may be added to the List. --------------------------------------------------------------------------- \5\ Howard J, Administrator of the WTC Health Program. Policy and procedures for adding non-cancer conditions to the List of WTC- Related Health Conditions. October 21, 2014. http://www.cdc.gov/wtc/pdfs/WTCHP_PP_Adding_NonCancers_21_Oct_2014.pdf. \6\ The substantial evidence standard is met when the Program assesses all of the available, relevant information and determines with high confidence that the evidence supports its findings regarding a causal association between the 9/11 exposure(s) and the health condition. \7\ The modest evidence standard is met when the Program assesses all of the available, relevant information and determines with moderate confidence that the evidence supports its findings regarding a causal association between the 9/11 exposure(s) and the health condition. \8\ 9/11 agents are chemical, physical, biological, or other agents or hazards reported in a published, peer-reviewed exposure assessment study of responders or survivors who were present in the New York City disaster area, or at the Pentagon site, or the Shanksville, Pennsylvania site as those locations are defined in 42 CFR 88.1. --------------------------------------------------------------------------- IV. COPD A. CCE and Data Center Request to Consider Adding New-Onset COPD On May 13, 2014, the Administrator received a letter from the directors of the WTC Health Program Clinical Centers of Excellence (CCEs) and Data Centers, asking that the Administrator consider all requests for certification of COPD.\9\ The Zadroga Act and WTC Health Program regulations identify ``WTC-exacerbated chronic obstructive pulmonary disease (COPD)'' as a covered health condition.\10\ However, the CCE and Data Center directors requested that the Administrator determine that COPD is a certifiable WTC condition, regardless of the date of onset.\11\ In order to certify all cases of COPD, including cases diagnosed after the September 11, 2001, terrorist attacks, new- onset COPD would need to be added to the List of WTC-Related Health Conditions. The Administrator directed the ADS to initiate a review of research regarding COPD in 9/11-exposed populations in order to determine whether there was support for such an addition. --------------------------------------------------------------------------- \9\ See: Crane M, Lucchini R, Moline J, Prezant D, Kelly K, Udasin I, Luft B, Harrison D, Reibman J [2014]. Rationale for the continued certification of COPD as a World Trade Center related and covered condition. Letter from WTC Health Program Data Center and Clinical Centers of Excellence Directors to Drs. Dori Reissman and John Halpin, WTC Health Program. This letter is included in the docket for this rulemaking. \10\ PHS Act, sec. 3312(a)(3)(A)(v); 42 CFR 88.1. \11\ COPD letter from WTC Health Program CCE and Data Center Directors to Drs. Dori Reissman and John Halpin, WTC Health Program at 8. --------------------------------------------------------------------------- B. Literature Review In accordance with the established methodology for the addition of non-cancers to the List, the Administrator charged the ADS with conducting a review of the relevant, peer-reviewed, published studies of 9/11-exposed populations. Because definitions of COPD vary among authorities, the ADS first had to identify the best definition for the purposes of the WTC Health Program. [[Page 54749]] The ADS looked to the Global Initiative for Chronic Obstructive Lung Disease (GOLD), a collaboration between the National Heart, Lung, and Blood Institute of the National Institutes of Health and the World Health Organization as a point of reference. GOLD defines COPD as persistent airflow limitation that is usually progressive and associated with an enhanced chronic inflammatory response in the airways and the lung to noxious particles or gases.\12\ COPD is an umbrella term that encompasses those pulmonary conditions exhibiting chronic inflammation of the airways, lung tissue, and pulmonary blood vessels and persistent airflow limitation: A combination of large and small airways disease (obstructive chronic bronchitis \13\ and obstructive bronchiolitis, respectively) and parenchymal destruction (emphysema).\14\ According to GOLD, the three principal symptoms of COPD are dyspnea (shortness of breath), chronic cough, and sputum production; the most common early symptom is dyspnea on exertion (DOE). COPD should always be considered when these lower respiratory symptoms and history of exposure to risk factors for the disease are present. Because many of the symptoms of COPD are similar to asthma symptoms, both conditions are classified as obstructive airways diseases (OAD). The airway obstruction in asthma is usually reversible after bronchodilator therapy, whereas the obstruction in COPD is poorly- reversible or irreversible.\15\ While asthma is not included under the term COPD, people with asthma may develop COPD over time.\16\ --------------------------------------------------------------------------- \12\ Global Initiative for Chronic Obstructive Lung Disease (GOLD), Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease, updated 2014. http://www.goldcopd.org/uploads/users/files/GOLD_Report_2014_Jan23.pdf. \13\ Chronic bronchitis is defined by the presence of a productive cough of more than 3 months' duration for more than two successive years. It becomes obstructive chronic bronchitis if spirometric evidence of airflow obstruction develops. See: Chronic Obstructive Pulmonary Disease (COPD) [2014]. In R.S. Porter et al. (Eds.), The Merck manual of diagnosis and therapy. http://www.merckmanuals.com/professional/pulmonary_disorders/chronic_obstructive_pulmonary_disease_and_related_disorders/chronic_obstructive_pulmonary_disease_copd.html. \14\ Emphysema is destruction of lung parenchyma (the portion of the lung involved in gas transfer, including the alveoli, alveolar ducts and respiratory bronchioles) leading to loss of elastic recoil and loss of alveolar septa and radial airway traction, which increases the tendency for airway collapse. Lung hyperinflation, airflow limitation, and air trapping are present. See: Chronic Obstructive Pulmonary Disease (COPD) [2014]. In R.S. Porter et al. (Eds.), The Merck manual of diagnosis and therapy. http://www.merckmanuals.com/professional/pulmonary_disorders/chronic_obstructive_pulmonary_disease_and_related_disorders/chronic_obstructive_pulmonary_disease_copd.html. \15\ American Thoracic Society [1987]. Standards for the diagnosis and care of patients with chronic obstructive pulmonary disease (COPD) and asthma. Official statement of the American Thoracic Society was adopted by the Board of Directors, November 1986. Am Rev Respir Dis. 136(1):225-244. \16\ Global Initiative for Asthma [2015]. Global strategy for asthma management and prevention; updated 2015. http://www.ginasthma.org/local/uploads/files/GINA_Report_2015.pdf. --------------------------------------------------------------------------- Diagnosis of COPD requires the use of a spirometry test, which measures how much and how quickly an individual inhales and exhales air from his or her lungs. The diagnosis of COPD is confirmed by a spirometry test demonstrating poorly-reversible or irreversible airways obstruction (i.e., the proportion of vital capacity that an individual is able to expire in the first second of expiration [FEV1/FVC or FEV1%] is below 70 percent) after use of a bronchodilator. Although spirometry is the standard diagnostic test for COPD, in some circumstances, impulse oscillometry (IOS) can be complementary to spirometry, especially in patients at advanced age and with physical or mental disorders who cannot be diagnosed through spirometry. IOS assesses airway resistance and frequency dependence of resistance (FDR). FDR provides a measure of nonuniformity of airflow distribution, which may reflect regional functional abnormalities in the distal airways not captured by the spirometry test. In accordance with the GOLD definition, described above, the ADS initiated a literature search for ``chronic obstructive pulmonary disease,'' ``chronic bronchitis,'' ``pulmonary emphysema,'' ``pulmonary function decline,'' ``respiratory insufficiency,'' ``airways obstruction,'' and ``airflow limitation.'' \17\ The literature search yielded 108 study citations; the associated study abstracts were reviewed for relevance to 9/11-exposed populations.\18\ Of the 108 citations identified, 36 were determined to be relevant epidemiologic studies of 9/11-exposed populations. Relevant papers were then further reviewed for their quality and potential to provide a basis for deciding whether to propose adding the health condition to the List of WTC-Related Health Conditions. Only papers that reported post-9/11 lower respiratory symptomatology and objective measurements of airways obstruction, such as pre- and post-9/11 spirometry with bronchodilator administration or IOS, were found to exhibit potential support for an addition recommendation. Quality was assessed by the presence or absence of major limitations, such as small size or poor comparability of study groups; use of unreliable or invalid measurement instruments; and if little or no attention was given to key confounders which would call into question the validity of the study results. Based on these criteria, the ADS found six relevant papers which exhibited potential to provide a basis for a decision regarding whether to propose the addition of new-onset COPD to the List. The six papers are summarized below. --------------------------------------------------------------------------- \17\ Databases searched include: PubMed, Embase, CINAHL, Web of Science, Health & Safety Science Abstracts, and Toxline. \18\ Only epidemiologic studies of 9/11-exposed populations were considered to be relevant. Case series and review papers were not found to be relevant. --------------------------------------------------------------------------- Weiden et al. [2010] \19\ sought to determine the pathophysiologic basis for observed reductions in lung function among 1,720 Fire Department of New York (FDNY) rescue workers (firefighters and emergency medical service personnel) who presented for pulmonary evaluation between September 12, 2001 and March 10, 2008. Exposure intensity was categorized based on first arrival time at the WTC site as follows: High exposure if they arrived during the morning of September 11, 2001, intermediate exposure if they arrived after the morning of September 11, 2001, but within the first 2 days, and low exposure if they arrived between days 3 and 14. Pre-9/11 spirometry results were available for 92 percent of participants. Researchers obtained 919 full pulmonary function tests (bronchodilator response, lung volumes, diffusing capacity); 1,219 methacholine challenge tests to screen for asthma; and 982 high-resolution computed tomography (HRCT) scans, allowing them to report correlations between physiologic and radiographic measures. All physiologic tests pointed to airway obstruction with air trapping (demonstrated by the increase in residual volume) which correlated with the decline in FEV1 post-9/11, bronchodilator responsiveness, and hyperreactivity. HRCT findings of bronchial wall thickening (which reflects proximal airway inflammation and/or remodeling) and emphysema were reported in 26 percent and 12 percent of the participants, respectively. [[Page 54750]] Importantly, airway abnormalities on CT scans also correlated with physiologic measures. The authors concluded that airways injury and obstruction were the predominant pathophysiologic characteristics among study participants. --------------------------------------------------------------------------- \19\ Weiden MD, Ferrier N, Nolan A, Rom WN, Comfort A, Gustave J, Zeig-Owens R, Zheng S, Goldring RM, Berger KI, Cosenza K, Lee R, Webber MP, Kelly KJ, Aldrich TK, Prezant D [2010]. Obstructive airways disease with air trapping among firefighters exposed to World Trade Center dust. Chest. 137(3):566-574. --------------------------------------------------------------------------- Aldrich et al. [2010] \20\ evaluated the long-term effects of exposure to WTC dust on FDNY members who responded to the September 11, 2001, terrorist attacks. The authors analyzed the pulmonary function (FEV1) of both active and retired FDNY rescue workers on the basis of spirometry routinely performed at intervals of 12 to 18 months from March 12, 2000 to September 11, 2008. The authors observed a large decline in FEV1 values at 6 months and 12 months after September 11, 2001, especially among the firefighters with the heaviest dust exposure (those arriving at the WTC site on the morning of September 11, 2001). After the initial decline in the first year, the adjusted FEV1 continued to decline in smokers and non-smokers with little or no recovery in lung function during the subsequent 6 years. The authors concluded that the large decline in FEV1 after September 11, 2001, was indicative of airways injury due to 9/11 exposures. --------------------------------------------------------------------------- \20\ Aldrich TK, Gustave J, Hall CB, Cohen HW, Webber MP, Zeig- Owens R, Cosenza K, Christodoulou V, Glass L, Al-Othman F, Weiden MD, Kelly KJ, Prezant D [2010]. Lung function in rescue workers at the World Trade Center after 7 years. N Engl J Med. 362(14):1263- 1272. --------------------------------------------------------------------------- Webber et al. [2011] \21\ examined the prevalence of physician- diagnosed respiratory conditions in FDNY members up to 9 years after rescue/recovery efforts in the New York City disaster area. The authors reviewed self-reported physician diagnoses of asthma, chronic bronchitis, COPD/emphysema, and sinusitis from the most recent physical health survey conducted by the FDNY Bureau of Health Services and physician diagnoses obtained from FDNY electronic medical records. The study population consisted of 10,943 firefighters and EMS workers who first arrived at the site within 2 weeks of the terrorist attacks. All participants were free of COPD and emphysema before September 11, 2001, and less than 1 percent had asthma. The authors found the prevalence rates of both self-reported and physician diagnoses of OAD, i.e., asthma, chronic bronchitis, COPD/emphysema, and sinusitis were elevated, exceeding rates in the general population for individuals of a similar age. The highest proportion of FDNY responders with physician-diagnosed OAD had the lowest lung function (FEV1% predicted), indicating that 9/11 exposure had resulted in disease. The authors were unable to attribute these diagnoses to any other occupational exposures. --------------------------------------------------------------------------- \21\ Webber MP, Glaser MS, Weakley J, Soo J, Ye F, Zeig-Owens R, Weiden MD, Nolan A, Aldrich TK, Kelly K, Prezant D [2011]. Physician-diagnosed respiratory conditions and mental health symptoms 7-9 years following the World Trade Center disaster. Am J Ind Med. 54(9):661-671. --------------------------------------------------------------------------- Weakley et al. [2011] \22\ compared the prevalence of self-reported post-9/11 physician-diagnosed respiratory conditions (sinusitis, asthma, COPD/emphysema, and bronchitis) in 9/11-exposed FDNY firefighters to the prevalence in demographically similar National Health Interview Survey (NHIS) participants by year. The authors analyzed 45,988 questionnaires completed by 10,999 firefighters from October 2001 to September 2010. They reported higher rates of respiratory diagnoses in 9/11-exposed firefighters compared to the U.S. male general population, regardless of smoking status. Prevalence ratios, comparing FDNY to NHIS rates, were highest for COPD/emphysema and bronchitis. Because of the decrease in structural fires, improvement in personal protective equipment, and the decline in smoking rates among firefighters, the authors discounted normal firefighting activities as the cause of the increase in respiratory diagnoses. --------------------------------------------------------------------------- \22\ Weakley J, Webber MP, Gustave J, Kelly K, Cohen HW, Hall CB, Prezant DJ [2011]. Trends in respiratory diagnoses and symptoms of firefighters exposed to the World Trade Center disaster: 2005- 2010. Prev Med. 53(6):364-369. --------------------------------------------------------------------------- Friedman et al. [2011] \23\ also examined the relationship between 9/11 exposures, post-9/11 lower respiratory symptoms, and pulmonary function in a nested case-control study of exposed survivors 7-8 years after September 11, 2001. The cases examined in the study were 274 WTC Health Registry participants who reported post-9/11 onset of a lower respiratory symptom. One-third of the cases further reported post-9/11 physician diagnoses of asthma, chronic bronchitis, chronic obstructive pulmonary disease, or emphysema. Registry participants without lower respiratory symptoms or inhaler use and no current or past lung disease were used as control subjects. Only never-smokers participated in this study. Pulmonary function was assessed by spirometry and IOS. A higher proportion of abnormal spirometry results (obstructive and restrictive patterns) was found among cases than control subjects. IOS measurements of airway resistance and FDR (indicative of distal airways dysfunction) were significantly higher in cases than in control subjects, even when spirometry was normal. Lower respiratory symptoms were found significantly associated with IOS measurements but not with spirometry. Both exposure factors and IOS outcomes were associated with persistent symptoms, but exposure was not associated with IOS outcomes in the absence of symptoms. Certain exposure factors, including dust cloud density, smoke at home or work, and dust at home or work, were the strongest predictors of case status. The authors concluded that the association between post-9/11 onset of lower respiratory symptoms and lung function abnormalities detected by spirometry and IOS several years later were indicative of persistent airway disease with distal airways dysfunction as a contributing mechanism for these symptoms. --------------------------------------------------------------------------- \23\ Friedman SM, Maslow CB, Reibman J, Pillai PS, Goldring RM, Farfel MR, Stellman SD, Berger KI [2011]. Case-control study of lung function in World Trade Center Health Registry area residents and workers. Am J Respir Crit Care Med. 184(5):582-589. --------------------------------------------------------------------------- In a follow-up to the Friedman study reviewed above, Maslow et al. [2012] \24\ assessed associations between repeatedly reported lower respiratory symptoms and detailed measures of both acute and chronic 9/ 11-related exposures. Acute exposures involved contact with the dust cloud created by the towers' collapse. Chronic factors were based on conditions in the home or work site through December 31, 2001, such as the extent of dust coverage; the duration of detectable smoke, fumes, and other odors; and whether the participant engaged in or was exposed to cleaning. The authors concluded that both acute and chronic exposures to the events of 9/11 were independently associated, often in a dose-dependent manner, with lower respiratory symptoms reported 2 to 3 years and again 5 to 6 years after September 11, 2001 by individuals who lived and worked in the WTC area. --------------------------------------------------------------------------- \24\ Maslow CB, Friedman SM, Pillai PS, Reibman J, Berger KI, Goldring R, Stellman SD, Farfel M [2012]. Chronic and acute exposures to the world trade center disaster and lower respiratory symptoms: Area residents and workers. Am J Public Health. 102(6):1186-1194. --------------------------------------------------------------------------- C. Administrator's Determination Concerning New-Onset COPD The ADS assessed each of the six studies described above according to the methodology established by the Administrator. The studies were assessed for relevance, quality, bias, and confounding by applying criteria extrapolated from the Bradford Hill criteria.\25\ --------------------------------------------------------------------------- \25\ Criteria extrapolated from Bradford Hill criteria include: (i) Strength of the association between a 9/11 exposure and a health condition (including the magnitude of the effect and statistical significance); (ii) Consistency of the findings across multiple studies; (iii) Biological gradient, or dose-response relationships between 9/11 exposures and the health condition; and (iv) Plausibility and coherence with known facts about the biology of the health condition. See: Howard J, Administrator of the WTC Health Program. Policy and procedures for adding non-cancer conditions to the List of WTC-Related Health Conditions. October 21, 2014. http://www.cdc.gov/wtc/policies.html#46. --------------------------------------------------------------------------- [[Page 54751]] First, the studies were assessed for strength of the association between 9/11 exposures and a health condition (including the magnitude of the effect and statistical significance). Weiden et al. reported statistically significant longitudinal declines in FEV1, greater than expected by age or weight gain, among firefighters with documented high levels of exposure. Aldrich et al. reported significant substantial declines in FEV1 over the first year after the September 11, 2001, terrorist attacks and little lung function recovery among the FDNY participants 6 years after the disaster. The firefighters with the heaviest dust exposure (those arriving at the WTC site on the morning of the disaster) had significantly larger declines than did those arriving at later times. Importantly, the findings of both studies were independent of smoking history. A major limitation of both studies was the lack of spirometry during the first days after September 11, 2001, preventing the authors from determining whether some workers had an even more severe immediate decline in FEV1 and subsequent incomplete recovery. The possibility of systematic bias occurring due to the change of spirometer equipment between measurements and a loss-to- follow-up effect due to drop out of severely affected participants from the study over time (survivor effect) were additional concerns [Aldrich et al.]; however, these appeared to have been minimized by further statistical analyses and strong cohort retention rate, respectively. In addition to the Weiden and Aldrich studies, strength of association was also demonstrated by Weakley et al., who found that annual estimates from 2007-2009 indicated prevalence ratios of chronic bronchitis and COPD/emphysema that were significantly higher among exposed white male firefighters than unexposed white males (stratified by age and smoking status), with greater disparity in the younger age group (18-44 years). Similarly, Webber et al. reported significant associations of 9/11 exposures and reduced pulmonary function with physician-diagnosed asthma, chronic bronchitis, and COPD/emphysema in a high proportion of FDNY rescue workers, indicating that persistent respiratory injury since exposure to the WTC had resulted in obstructive airways disease. A major limitation of both studies was the use of self-reported diagnoses, including diagnoses made by any physician (FDNY or otherwise) and self-diagnoses, which may have over- inflated the prevalence rates. This limitation is a concern, especially for COPD/emphysema, which can be defined in a variety of ways; the definition used can have a significant impact on the population estimates of the burden of disease. However, many cases of COPD/ emphysema in this cohort were also diagnosed by FDNY physicians [Webber et al.] who were trained to diagnose respiratory diseases using defined diagnostic criteria after integrating the history, physical examination, spirometry, pulmonary function testing and chest imaging findings. Finally, among WTC Health Registry (Registry) participants, exposure factors (dust cloud density, smoke at home or work, and dust at home or work) and IOS outcomes (indicative of distal airways obstruction) were statistically associated with persistent post-9/11 onset of lower respiratory symptoms [Friedman et al.]. Both acute and chronic exposures to the events of September 11, 2001 were independently associated with lower respiratory symptoms among individuals who lived and worked in the area of the WTC site [Maslow et al.]. Limitations of these studies include the use of spirometry and IOS measurements from a single visit and the possibility of selection bias from Registry surveys. However, the demographics were similar among Registry participants and those who were eligible but chose not to participate in the studies. The studies were next assessed for consistency of their findings. Objective findings of new onset, post-9/11 and persistent airflow limitation, as well as physician-diagnosed cases of COPD, including chronic bronchitis and COPD/emphysema, were identified among symptomatic FDNY responders for whom pre-9/11 results were available [Weiden et al.; Aldrich et al.; Webber et al.; Weakley et al.]. Elevated rates of lung function abnormalities, including distal airway dysfunction, new and persistent lower respiratory symptomatology, and a few post-9/11 self-reported physician diagnoses of chronic bronchitis, COPD, and emphysema were also described among non-FDNY residents and area workers up to 9 years after September 11, 2001 [Friedman et al.; Maslow et al.]. The studies were also reviewed to assess the biological gradient or dose-response relationships between 9/11 exposures and the health condition. Newly developed lower respiratory symptoms and persistent pulmonary function abnormalities suggestive of airways injury and obstruction were significantly associated with 9/11 exposure in the FDNY studies, even after accounting for cigarette smoking. [Weiden et al.; Aldrich et al.; Webber et al.; Weakley et al.] Maslow et al. observed strong, significant associations and dose-response relationships between lower respiratory symptoms and every measure of severity of dust cloud exposure among WTC Health Registry participants. Weiden et al. also found a dose-response gradient (upward trend) in FDNY responders presenting for pulmonary evaluation due to reports of functional impairment or abnormalities in screening spirometry or chest radiographs. However, in this group of patients, exposure intensity had a significant impact only when spirometry obtained within 1 year post- 9/11 was compared to spirometry from 1 year pre-9/11. This suggests that while initial exposure intensity is the critical determinant of acute inflammation and early reductions in lung function, the clinical course of non-resolving airway inflammation and airways obstruction appears to be dependent not only on the intensity of the initial insult, but also on the host's inflammatory response, reflecting the complexity of genetic-environmental interactions. Finally, the studies were reviewed for plausibility and coherence with known facts about the biology of the health condition. Exposure to the massive alkaline dust cloud produced by the collapse of the WTC buildings was reportedly associated with upper and lower airway irritation with penetration into the bronchial tree, distal airways, and alveoli leading to respiratory symptoms, pulmonary function changes, and chronic inflammation. These are known contributing risk factors for the development of COPD.\26\ Persistent pulmonary function findings of reduced FEV1, FVC and the ratio of FEV1/FVC, bronchial hyperreactivity, variable response to bronchodilator, and abnormal oscillometry were indicative of airway injury. Airway disease was also identified as bronchial wall thickening and air trapping by HRCT [Weiden et al.]. Air trapping (demonstrated by increased residual volume) was correlated with [[Page 54752]] bronchodilator responsiveness; however, the lack of quantitative radiographic measurement of air trapping was a limitation of this study. Interestingly, the authors noted that bronchodilator response can be seen in COPD patients when air trapping is present. Epidemiologically, identification of occupationally-related COPD is based on observing excess occurrence of COPD among exposed workers.\27\ Among 9/11-exposed populations, this excess occurrence can be expressed not only by the increased prevalence ratios of new-onset post-9/11 self-reported and physician-diagnosed chronic bronchitis and emphysema/ COPD in the FDNY cohort [Webber et al.; Weakley et al.], but also by evidence of persistent and progressive airflow limitation among all other symptomatic exposed groups [Friedman et al.; Maslow et al.]. --------------------------------------------------------------------------- \26\ Rom WN, Reibman J, Rogers L, Weiden MD, Oppenheimer B, Berger K, Goldring R, Harrison D, Prezant D [2010]. Emerging exposures and respiratory health: World Trade Center dust. Proc Am Thorac Soc. 7(2):142-145. \27\ Balmes J, Becklake M, Blanc P, Henneberger P, Kreiss K, Mapp C, Milton D, Schwartz D, Toren K, Viegi G [2003]. American Thoracic Society Statement: Occupational contribution to the burden of airway disease. Am J Respir Crit Care Med. 167:787-797. --------------------------------------------------------------------------- In summary, obstructive airways disease is a category that includes both asthma and the umbrella term COPD, which itself includes obstructive chronic bronchitis, obstructive bronchiolitis, and emphysema. Upon assessment of the literature discussed above, the Administrator has found evidence that exposure to WTC dust is associated with the development of new-onset lower respiratory symptoms, prolonged airway inflammation and persistent airflow limitation, which are the main indicators of chronic airways obstruction. While it is difficult to demonstrate that the airway obstruction found in WTC survivors and responders is due to COPD versus asthma, three studies reported cases of physician-diagnosed COPD/ emphysema, one reported on IOS findings of air trapping and increased small airways resistance, and another study reported on HRCT findings of bronchial wall thickening, air trapping and emphysema, indicating that some proportion of OAD cases found in WTC survivors and responders could be interpreted as COPD. Further, because some cases of asthma are known to progress to COPD, it is likely that some of the diagnosed cases of asthma seen in these and other epidemiologic studies of the 9/ 11-exposed populations have already progressed to COPD. In order to propose the addition of a health condition to the List, the Administrator must determine with high confidence that the evidence supports the findings regarding a causal association between 9/11 exposure(s) and the health condition. In this instance, the Administrator finds there is substantial evidence that the 9/11 exposures produced chronic airway inflammation manifested by persistent lower respiratory symptomatology and decline in pulmonary function which may have progressed to new-onset COPD in a proportion of exposed subjects in the period since exposure, independently from any cigarette smoking among the cohort. This evidence provides substantial support for a causal relationship between 9/11 exposures and new-onset COPD. V. Acute Traumatic Injury A. CCE and Data Center Request To Consider Adding Acute Traumatic Injury On May 13, 2014, the Administrator received a letter from the directors of the WTC Health Program CCEs and Data Centers supporting ``coverage of not only heavy lifting or repetitive strain but significant traumatic injuries like head trauma, burns, fractures, tendon tears and serious complex sprains'' within the WTC Health Program.\28\ The directors suggested that such significant traumatic injuries should be included under the Program's existing coverage of musculoskeletal disorders. The directors offered data collected by the WTC Health Program Data Centers and the WTC Health Registry, demonstrating the numbers of individuals who might need chronic care for traumatic injuries. The Administrator was also aware that some individuals have experienced certain musculoskeletal injuries or other injuries caused by known hazards present at sites of the September 11, 2001, terrorist attacks that may not meet the definition provided in the Act for musculoskeletal disorders. Based on these concerns, the Administrator requested that the ADS conduct a literature review regarding acute traumatic injuries among 9/11-exposed individuals. --------------------------------------------------------------------------- \28\ Musculoskeletal Conditions letter from WTC Health Program CCE and Data Center directors to Dori Reissman and John Halpin, WTC Health Program at 1. This letter is included in the docket for this rulemaking. --------------------------------------------------------------------------- B. Literature Review In accordance with the methodology discussed above, the ADS initiated a search of published, peer-reviewed studies of traumatic injuries suffered by responders, recovery workers, and survivors as a result of the terrorist attacks on September 11, 2001, and the subsequent response and recovery efforts. Search terms used in the literature review included, ``wounds,'' ``lacerations,'' ``brain injury(ies),'' ``injury(ies),'' ``crush(ing),'' ``burn(s),'' ``ocular,'' and ``fracture(s).'' \29\ --------------------------------------------------------------------------- \29\ Databases searched include: PubMed, CINAHL, Web of Science, EMBASE, Health & Safety Science Abstracts, and NIOSHTIC-2. --------------------------------------------------------------------------- The literature search yielded over 300 citations; the associated study abstracts were reviewed for relevance to 9/11-exposed populations.\30\ Of the 300 citations identified, nine were determined to be relevant direct observational studies of 9/11-exposed populations. Relevant papers were then further reviewed for their quality and potential to provide a basis for deciding whether to propose adding the health condition to the List of WTC-Related Health Conditions. Only papers that reported on acute traumatic injuries that occurred in at least one of the three September 11, 2001, terrorist attack sites during the period from September 11, 2001 to July 31, 2002 were found to exhibit potential for a recommendation. Quality was assessed by the absence of major study limitations and the use of standardized data collection methods such as standard forms or checklists. Based on these criteria, one relevant study was not found to be of sufficient quality to be included in the analysis because it did not identify the authors' data collection methods. Of the remaining eight studies, the methods used to collect the information and the definitions of the types of injuries vary. The time frame studied and the populations covered sometimes overlap between the studies, but taken together the studies provide an overview of the types of traumatic injuries that were sustained at the sites of the September 11, 2001, terrorist attacks. Accordingly, the ADS found the eight relevant papers exhibited potential to provide a basis for a decision regarding whether to propose the addition of acute traumatic injury to the List. The studies are summarized below. --------------------------------------------------------------------------- \30\ Only direct observational studies of 9/11-exposed populations were considered to be relevant. --------------------------------------------------------------------------- Berrios-Torres et al. [2003] \31\ reviewed the data collected by five Disaster Medical Assistance Teams (DMATs) deployed by the U.S. Public Health Service to the site of the terrorist attack in New York City and by four hospital emergency departments (EDs) located within a 3-mile radius of the site. The DMATs and EDs were tasked with conducting surveillance of injury and illness among construction workers, [[Page 54753]] FDNY and other fire department members, New York Police Department (NYPD) and other police department members, emergency medical service technicians (EMS), and the Federal Emergency Management Agency's Urban Search and Rescue members, all of whom were considered rescue and recovery workers. Of the 5,222 rescue workers who received medical care from either the DMATs or EDs between September 14, 2001 and October 11, 2001, 89 percent visited DMAT facilities and 12 percent visited EDs. Injuries including, but not limited to, sprain/strain, laceration, abrasion, contusion, fracture, and crush were the leading cause of visits to DMATs and EDs (19 percent) and hospital admissions (40 percent). Other visits and admissions were caused by burns, concussions, and eye-related conditions, including corneal abrasion and eye irritation. --------------------------------------------------------------------------- \31\ Berrios-Torres SI, Greenko JA, Phillips M, Miller JR, Treadwell T, Ikeda RM [2003]. World Trade Center rescue worker injury and illness surveillance, New York, 2001. Am J Prev Med 25:79-87. --------------------------------------------------------------------------- Perritt et al. [2005] \32\ analyzed DMAT data collected between September 14, 2001 and November 20, 2001. Patients who presented to the DMAT stations included rescue and recovery workers, as well as some members of the general public. Of the 9,349 patient visits recorded by the DMATs, more than 25 percent were attributed to traumatic injuries, not including eye injuries. Among the 22 patients with the highest triage severity classification, five involved traumatic injuries such as carbon monoxide poisonings, abrasions, needlesticks, electrical injuries, and first or second degree burns. Of the 149 patients with a moderate level of severity, 58 had traumatic injuries. For the 6,237 patients classified into the lowest severity category, 1,984 had traumatic injuries. Of the 116 patients transferred to a hospital emergency department, 67 were treated for traumatic injuries. --------------------------------------------------------------------------- \32\ Perritt KR, Boal WL, Helix Group [2005]. Injuries and illnesses treated at the World Trade Center, 14 September-20 November 2001. Prehosp Disast Med 20:177-183. --------------------------------------------------------------------------- Banauch et al. [2002] \33\ reported on all injuries and illnesses during the 24 hours after the September 11, 2001, terrorist attacks and all traumatic injuries (including those sustained within the first 24 hours) sustained in the first 3 months after the attacks. Researchers identified cases from the FDNY Bureau of Health Services computerized medical data base. During the first 24 hours after the terrorist attacks, 240 FDNY rescue workers sought emergency medical treatment, including 28 individuals who required hospitalization. Twenty-four of the hospitalized FDNY workers had traumatic injuries including fractures, back trauma, knee meniscus tears, and facial burns. Researchers compared monthly mean incidence rates for crush injuries, lacerations, and fractures for the 9 months preceding the attacks with rates during the month after the attacks and found a 200 percent increase in the incident rate for crush injuries, a 35 percent increase for lacerations, and a 29 percent increase for fractures. Incident rates for such traumatic injuries after the first month following the attack then returned to levels similar to those observed before the attacks. According to the authors, nearly a year after the terrorist attacks, a total of 90 FDNY rescue workers were on medical leave or light duty assignments because of orthopedic injuries reported during the first 3 months of activity at the New York City site. --------------------------------------------------------------------------- \33\ Banauch G, McLaughlin M, Hirschhorn R, Corrigan M, Kelly K, Prezant D [2002]. Injuries and illnesses among New York City Fire Department rescue workers after responding to the World Trade Center attacks. MMWR September 11, 2002, 51(Special Issue):1-5. --------------------------------------------------------------------------- The New York City Department of Health (NYCDOH) [2002] \34\ issued a report summarizing findings of a field investigation to assess injuries and use of healthcare services by survivors of the terrorist attack. The researchers reviewed emergency department (ED) and inpatient medical records at the four hospitals closest to the WTC site and a fifth hospital that served as a burn referral center. Of 790 injured survivors treated within 48 hours of the terrorist attacks, 50 percent received care within the first 7 hours and 18 percent were hospitalized. Among those hospitalized survivors, many sustained burns. Survivors with fractures, burns, closed head injuries, and crush injuries were hospitalized for additional treatment. --------------------------------------------------------------------------- \34\ New York City Department of Health (NYCDOH) [2002]. Rapid assessment of injuries among survivors of the terrorist attacks on the World Trade Center--New York City, September 2001. MMWR January 11, 2002, 51(01):1-5. --------------------------------------------------------------------------- Perritt et al. [2011] \35\ reviewed data collected between July 2002 and April 2004 from the WTC Worker and Volunteer Medical Screening Program (which would later be known as the WTC Medical Monitoring and Treatment Program, the precursor to the WTC Health Program) to monitor the health of qualified New York City responders who worked and/or volunteered south of Canal Street in Manhattan, on the barge loading piers in Manhattan, or at the Staten Island landfill for at least 24 hours during September 11-30, 2001 or for at least 80 hours between September 11 and December 31, 2001. The screening program did not include FDNY members. Records from 7,810 participants were analyzed, with most participants' activities associated with work in either the construction industry or law enforcement. Approximately a third of the participants reported at least one injury or illness requiring medical treatment that was sustained during response activities. A total of 4,768 injuries/illnesses were reported by these participants, with 961 individuals reporting traumatic injuries such as lacerations, punctures, sprain/strains, tears, abrasions, contusions, burns, fractures, dislocations and 709 individuals reporting eye injuries. --------------------------------------------------------------------------- \35\ Perritt KR, Herbert R, Levin SM, Moline J [2011]. Work- related injuries and illnesses reported by World Trade Center response workers and volunteers. Prehosp Disast Med 26(6): 401-407. --------------------------------------------------------------------------- Yurt et al. [2005] \36\ reported on the number of burn patients (the authors did not specify whether the patients were responders or survivors) that had been transported to any of five burn units near the WTC site shortly after the attack. A total of 42 patients were transported from the WTC site and treated at one of the five burn units. --------------------------------------------------------------------------- \36\ Yurt RW, Bessey PQ, Bauer GJ, Dembicki R, Laznick H, Alden N, Rabbits A [2005]. A regional burn center's response to a disaster: September 11, 2001, and the days beyond. J Burn Care Rehab 26: 117-124. --------------------------------------------------------------------------- Rutland-Brown et al. [2007] \37\ reviewed the medical records of hospitalized responders (the authors do not clarify whether FDNY members are included in the study) and survivors of the terrorist attacks in New York City with the goal of identifying diagnosed and undiagnosed traumatic brain injuries (TBIs).\38\ The authors identified 14 cases of diagnosed and 21 cases of undiagnosed TBIs, from records provided by 36 hospitals. The leading cause of TBI was being hit by falling debris (22 cases), with other cases caused by being trampled or falling. One-third of the TBIs (13 cases) occurred among rescue workers. More than 3 years after the event, four out of six persons with an undiagnosed TBI who were contacted reported they currently were experiencing symptoms consistent with a TBI. Wang et al. [2005] \39\ reported on the experience of hospitals in the area around the Pentagon after the terrorist attacks. According to the authors, few [[Page 54754]] severely injured patients were treated at these hospitals and the traumatic injuries treated at these hospitals included orthopedic injuries, head injuries, burns, and lacerations. No reports of traumatic injuries that may have been treated at the site were identified. --------------------------------------------------------------------------- \37\ Rutland-Brown W, Langlois JA, Nicaj L, Thomas RG, Wilt SA, Bazarian JJ [2007]. Traumatic brain injuries after mass-casualty incidents: Lessons from the 11 September 2001 World Trade Center attacks. Prehosp Disast Med 22(3):157-164. \38\ Undiagnosed or undetected TBIs were identified by an adjudication team of TBI experts that reviewed the abstracted medical record information for signs and symptoms of TBIs. \39\ Wang D, Sava J, Sample G, Jordan M [2005]. The Pentagon and 9/11. Crit Care Med 33:S42-S47. --------------------------------------------------------------------------- C. Administrator's Determination Concerning Acute Traumatic Injury The ADS assessed each of the identified studies according to the methodology established by the Administrator. All of the studies discussed above were observational reports of visits by responders and survivors to area hospitals, burn units, and DMATs. Because these were direct observational studies rather than epidemiologic studies, they were assessed for relevance, quality, and quantity to determine whether, taken together, they provide substantial evidence supporting the addition of acute traumatic injury to the List. First, the ADS assessed the relevance of the eight studies described above. Because most of the individuals who were treated at the DMATs and in area hospitals sustained injuries from fires and falling debris in the conduct of rescue operations or fleeing from the site, all of the studies reference the period of time immediately following the September 11, 2001, terrorist attacks, and several refer to data collected for months after. The studies assessed by the ADS demonstrate the occurrence of the same types of acute traumatic injuries identified by the directors of the CCEs and Data Centers in their letter: Severe burns, head trauma, fractures, tendon tears, and complex sprains. Other similar injuries identified in the studies include eye injuries, lacerations, and orthopedic injuries. There were no severe types of injuries referenced in the surveillance literature that have not been documented by the CCEs. Furthermore, the ADS determined that all of the referenced types of injuries could be described as being caused by a brief exposure to energy. Accordingly, the ADS found these eight studies to be relevant. Next, the ADS assessed the quality of the studies and found that many shared common limitations, such as: incomplete data sets (e.g., potential inability to include individuals who sustained only minor injuries, or who were treated outside of Manhattan, by private doctors, or by themselves); missing or inconsistent information on hastily- completed medical forms, including lack of information about patients' work activity or residency; and recall bias. It is understandable that certain demographic data were not captured by healthcare providers in the chaotic days and weeks after the September 11, 2001, terrorist attacks; the missing data are not essential to the Administrator's understanding of the types of acute traumatic injuries sustained. Although injury rates are used to develop the economic analysis found in this document, the consideration of whether to propose the addition of acute traumatic injury to the List is not contingent upon knowing the exact prevalence of types of injuries sustained by responders or survivors. Accordingly, the ADS finds that the studies reviewed above are of sufficient quality and quantity to allow the Administrator to develop an understanding of the type and scope of the traumatic injuries suffered on September 11, 2001, or in its aftermath. Finally, the ADS assessed the quantity of the studies and found it to be sufficient. The eight relevant studies analyzed and reviewed overlapping populations affected by the attacks and response activities. Taken together, the studies provide a broad coverage of the affected populations and consistent information on the types of acute traumatic injuries that occurred. Because data regarding responders to the Pentagon and Shanksville, Pennsylvania sites is limited, the ADS found it appropriate to extrapolate the findings discussed above, which predominantly concern the New York City site, to all responder populations because of the similar hazards at all three sites. In summary, the 9/11 exposures for acute traumatic injuries were the conditions at the sites during the attacks, collapses, evacuations, recovery, and clean-up. Acute traumatic injuries documented in the published scientific literature were sustained by construction workers, police officers, firefighters, emergency medical service technicians, others engaged in response activities, and survivors. Hazards at the WTC site, at the Pentagon, and in Shanksville, Pennsylvania may have included, but are not limited to, falling debris, fires, chemical reactions, explosions, and other dangers. These hazards caused a range of injuries, such as abrasions, burns, concussions, contusions, corneal abrasions, crushes, dislocations, eye irritation, fractures, head trauma, lacerations, orthopedic injuries, punctures, sprains/strains, and tears. Many of these types of injuries were likely minor, and did not require substantial or on-going attention. In their letter to the Administrator, the CCE and Data Center directors identified severe burns, head trauma, fractures, tendon tears, and complex sprains as those types of acute traumatic injuries that should be added to the List of WTC-Related Health Conditions for all WTC Health Program members. Accordingly, the Administrator has determined that the types of injuries most likely to have resulted in the need for medical treatment and monitoring by the WTC Health Program are those types identified by the CCE and Data Center directors and in the injury surveillance literature reviewed above. Upon review of the evidence provided by the relevant published, peer-reviewed direct observational studies discussed above, the Administrator finds substantial support for a causal association between 9/11 exposures and acute traumatic injuries. VI. 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 11th 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.\40\ --------------------------------------------------------------------------- \40\ 28 CFR 104.21(b). --------------------------------------------------------------------------- VII. Summary of Proposed Rule For the reasons discussed above, the Administrator proposes to amend 42 CFR 88.1, List of WTC-Related Health Conditions, paragraph (1)(v), to add ``new-onset'' to the existing ``WTC-exacerbated chronic obstructive pulmonary disease (COPD).'' This will permit the WTC Health Program to certify cases of COPD determined to have been caused or contributed to by 9/11 exposures (considered ``new-onset'' cases), in addition to those cases of COPD which were exacerbated by 9/11 exposures and which are already included on the List. For the reasons discussed above, the Administrator also proposes to add ``acute traumatic injury'' to the List of [[Page 54755]] WTC-Related Health Conditions. The Administrator proposes to define the term ``acute traumatic injury'' as a type of injury characterized by physical damage to a person's body, including, but not limited to, eye injuries, severe burns, head trauma, fractures, tendon tears, complex sprains, and similar injuries. The injury must have been caused by and occurred immediately after exposure to hazards or adverse conditions characterized by a one-time exposure to energy resulting from the terrorist attacks or their aftermath; this requirement is intended to distinguish these types of injuries from musculoskeletal disorders, which are already on the List of WTC-Related Health Conditions. Musculoskeletal disorders are generally caused by repetitive motion; acute traumatic injuries are caused by a specific event or incident. Examples of acute traumatic injuries include but are not limited to a blow from falling debris, a fall from a height or a trip suffered during evacuation, rescue, or recovery activities, and burns or other injuries caused by the ignition of combustible materials, chemical reactions, and explosions. Although these types of injury occur at the time of the blow, fall, explosion, or other exposure, symptoms of the injury may not immediately manifest. The Administrator proposes to limit the availability of certification of acute traumatic injuries to those WTC Health Program members who received initial medical treatment for the injury no later than September 11, 2003. The Administrator has determined that this date offers a reasonable amount of time in which to expect that an injured responder or survivor received treatment for an acute traumatic injury. The proposed end-date of September 11, 2003, is the date originally used to identify traumatic injuries determined to be eligible for treatment by the WTC Medical Monitoring and Treatment Program that pre-dated the WTC Health Program. In addition, the PHS Act uses this date as the treatment cut-off date to identify musculoskeletal disorders eligible for certification in responders. The Administrator seeks comment on whether September 11, 2003, is an appropriate deadline. VIII. Regulatory Assessment Requirements A. Executive Order 12866 and Executive Order 13563 Executive Orders (E.O.) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This notice of proposed rulemaking has been determined not to be a ``significant regulatory action'' under sec. 3(f) of E.O. 12866. This rule proposes the addition of new-onset COPD \41\ and acute traumatic injury to the List of WTC-Related Health Conditions established in 42 CFR 88.1. This rulemaking is estimated to cost the WTC Health Program between $5,124,477 and $9,350,966 for the years 2015 and 2016, the remaining years for which the WTC Health Program is currently funded under the Zadroga Act.\42\ All of the costs to the WTC Health Program will be transfers due to the implementation of provisions of the Patient Protection and Affordable Care Act (ACA) (Pub. L. 111-148) on January 1, 2014. This notice of proposed rulemaking has not been reviewed by the Office of Management and Budget (OMB). The rule would not interfere with State, local, and Tribal governments in the exercise of their governmental functions. --------------------------------------------------------------------------- \41\ WTC-exacerbated COPD is a statutorily covered condition pursuant to PHS Act sec. 3312(a)(3)(A)(v); this NPRM proposes to add new-onset COPD occurring after 9/11 exposures. \42\ Future cost and prevalence estimates described below are discounted at 3% and 7% in accordance with OMB Circular A-94, Guidelines and discount rates for benefit-cost analysis of Federal programs. The estimates are discounted in order to compute net present value. --------------------------------------------------------------------------- Population Estimates As of July 31, 2014, the WTC Health Program had enrolled 61,086 responders and 7,806 survivors (68,892 total). Of that total population, 56,334 responders and 4,754 survivors (61,088 total) were participants in previous WTC medical programs and were `grandfathered' into the WTC Health Program established by Title XXXIII of the PHS Act.\43\ From July 1, 2011 to July 31, 2014, 4,752 new responders and 3,052 new survivors (7,804 total) enrolled in the WTC Health Program. For the purpose of calculating a baseline estimate of new-onset COPD and acute traumatic injury prevalence, the Administrator projected that new enrollment would be approximately 4,000 per year (2,800 new responders and 1,200 new survivors), based on the trend in enrollees through July 31, 2014. --------------------------------------------------------------------------- \43\ 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.'' --------------------------------------------------------------------------- CCE or Nationwide Provider Network physicians will conduct a medical assessment for each patient and make a determination, which the Administrator will then use to certify or not certify the health condition (in this case, new-onset COPD or an acute traumatic injury) for treatment by the WTC Health Program. However, for the purpose of this analysis, the Administrator has assumed that all diagnosed cases of new-onset COPD and acute traumatic injury will be certified for treatment by the WTC Health Program. Finally, because there are no existing data on new-onset COPD rates related to 9/11 exposures at either the Pentagon or Shanksville, Pennsylvania sites, and only limited data on acute traumatic injuries at the Pentagon, the Administrator has used only data from studies of individuals who were responders or survivors in the New York City area. Prevalence of New-Onset COPD To estimate the number of potential cases of WTC-related new-onset COPD to be certified for treatment by the WTC Health Program, we first subtracted the number of current members certified for an obstructive airways disease, including WTC-exacerbated COPD, from the total number of members.\44\ We then reviewed the surveillance literature to determine a prevalence rate for new-onset COPD among the non-OAD certified members. In studies of FDNY members with known pre-9/11 health status and high WTC exposure, Aldrich et al. reported that 2 percent of FDNY firefighters had an FEV1% below 70 percent of predicted \45\ at year 1 after September 11, 2001 (a proportion that doubled 6.5 years later), and Webber et [[Page 54756]] al. reported an approximate 4 percent prevalence of new-onset, self- reported, physician-diagnosed COPD/emphysema nearly ten years after rescue/recovery efforts at the WTC site. Because pre-9/11 health records were not available in studies of WTC survivors, the Administrator has determined that the 4 percent prevalence of new-onset COPD will be applied to survivor estimates as well.\46\ We applied the 4 percent prevalence to the number of remaining members and also to the projected annual enrollment of 4,000 new members to estimate the number of potential WTC-related new-onset COPD cases for 2015 and 2016. (See Table 1, below) --------------------------------------------------------------------------- \44\ Cases of COPD diagnosed prior to September 11, 2001, are presumed to be eligible for coverage as WTC-exacerbated COPD and therefore would not need coverage for new-onset COPD. Members already certified for an obstructive airway disease are also removed from the analysis because any progression to COPD (i.e., airflow limitation not fully reversible with bronchodilator) from their current certified WTC-related OAD condition could be considered a health condition medically-associated with the certified WTC-related OAD condition. See: Howard J [2014]. Health conditions medically associated with World Trade Center-related health conditions. http://www.cdc.gov/wtc/pdfs/WTCHPMedically%20AssociatedHealthConditions7November2014.pdf. \45\ FEV1% predicted is a marker for severity of airway obstruction. In the setting of post-bronchodilator FEV1/FVC <=0.7, FEV1% predicted >=80 indicates mild COPD; 50-80, moderate; 30-50, severe, and <30, very severe. See: American Thoracic Society COPD Guidelines [2004]. http://www.thoracic.org/clinical/copd-guidelines/for-health-professionals/definition-diagnosis-and-staging/definitions.php. \46\ The 4 percent prevalence of new-onset COPD that was observed among firefighters was used to estimate the number of expected cases of new-onset COPD in the entire exposed cohort and may result in an overestimation because of the differences in initial exposure intensity between responders and survivors. Table 1--Estimated Prevalence of 2015 and 2016 New-Onset COPD Cases ---------------------------------------------------------------------------------------------------------------- 2015 2016 Total cases ---------------------------------------------------------------------------------------------------------------- Undiscounted ---------------------------------------------------------------------------------------------------------------- Responders...................................................... 2,013 2,125 4,138 Survivors....................................................... 291 339 630 ----------------------------------------------- Total....................................................... 2,304 2,464 4,768 ---------------------------------------------------------------------------------------------------------------- Discounted at 3% ---------------------------------------------------------------------------------------------------------------- Responders...................................................... 1,954 2,003 3,957 Survivors....................................................... 283 320 603 ----------------------------------------------- Total....................................................... 2,237 2,323 4,560 ---------------------------------------------------------------------------------------------------------------- Discounted at 7% ---------------------------------------------------------------------------------------------------------------- Responders...................................................... 1,881 1,856 3,737 Survivors....................................................... 272 296 568 ----------------------------------------------- Total....................................................... 2,153 2,152 4,305 ---------------------------------------------------------------------------------------------------------------- Prevalence of Acute Traumatic Injury While this rulemaking would make acute traumatic injuries eligible for certification, the Administrator assumes that the conditions most likely to receive treatment within the WTC Health Program will be those medically associated conditions which are the long-term consequences of the certified WTC-related acute traumatic injuries. Health conditions medically associated with WTC-related health conditions are determined on a case-by-case basis in accordance with WTC Health Program policy.\47\ Examples of such health conditions medically associated with an acute traumatic injury may include chronic back pain caused by vertebrae fractures, chronic peripheral neuropathy due to severe burns, and problems with executive brain function due to closed head injuries. --------------------------------------------------------------------------- \47\ Howard J [2014]. Health conditions medically associated with World Trade Center-related health conditions. http://www.cdc.gov/wtc/pdfs/WTCHPMedically%20AssociatedHealthConditions7November2014.pdf. --------------------------------------------------------------------------- Although we were able to estimate from the surveillance literature the number of responders and survivors who received medical treatment for acute traumatic injuries on or in the aftermath of September 11, 2001, we do not know the number of individuals who still experience health problems because of those traumatic injuries and are in need of chronic care. First, we estimated the number of persons in the responder and survivor populations with 9/11-related acute traumatic injuries by reviewing the studies referenced above in the acute traumatic injury literature review; we derived estimates from Berrios- Torres et al. [2003], Banauch et al. [2002], Perritt et al. [2011], and NYCDOH [2002]. Using the estimated prevalence for injury types, we then calculated the prevalence for these injuries among the responder \48\ and survivor \49\ populations. We applied that prevalence to the number of current and expected WTC Health Program members to find the number of individuals who may have suffered a WTC-related acute traumatic injury. Next, in order to estimate the proportion of those in the responder and survivor populations who suffered WTC-related acute traumatic injuries that require chronic care, we assumed that all patients with permanent partial and permanent total impairment caused by acute traumatic injuries will require chronic medical care and will enroll in the WTC Health Program. The National Safety Council estimated that 3.8 percent of non-fatal disabling injuries \50\ are associated with permanent partial or permanent total impairment.\51\ We applied that estimate to the estimated number of current and expected WTC Health Program members who may have suffered a WTC-related acute traumatic injury to determine the number of individuals with WTC- related acute traumatic injuries who are in need of chronic care. (See Table 2, [[Page 54757]] below.) The Administrator welcomes input on the assumptions and estimates used to determine the number of current and future WTC Health Program members who may seek certification of WTC-related acute traumatic injuries. --------------------------------------------------------------------------- \48\ The responder estimate is subject to two main assumptions. First, Banauch et al. report on FDNY members from September 11 to December 10, 2001, and we assume no additional injuries from December 11, 2001 until the site was closed in July 2002. The time period reported on by Banauch et al. likely encompasses a large majority of the injuries suffered by FDNY members. Second, Perritt et al. does not report directly on closed head injuries; therefore the number of closed head injuries reported by Berrios-Torres et al. for responders is used. \49\ We estimate the survivor prevalence from the NYCDOH study reports on survivors during the period from September 11-13, 2001. Although we understand that this reporting period likely encompasses a majority of the survivors who were injured, because the number of cases is based on those survivors who were treated for injuries only within the first 48 hours after the terrorist attacks, the reported number of cases likely underestimates the total number of survivors who sustained acute traumatic injuries as a result of the September 11, 2001, terrorist attacks. \50\ In 2011, the National Safety Council replaced the term ``disabling injury'' with ``medically consulted injury.'' See National Safety Council [2014]. Injury facts. \51\ A non-fatal disabling injury is one which results in some degree of permanent impairment or renders the injured person unable to effectively perform his regular duties or activities for a full day beyond the day of the injury. National Safety Council [1986]. Injury facts. Table 2--Estimated Prevalence of 2015 and 2016 Acute Traumatic Injury Cases ---------------------------------------------------------------------------------------------------------------- 2015 2016 Total cases ---------------------------------------------------------------------------------------------------------------- Undiscounted ---------------------------------------------------------------------------------------------------------------- Responders...................................................... 76 79 155 Survivors....................................................... 9 10 19 ----------------------------------------------- Total....................................................... 85 89 174 ---------------------------------------------------------------------------------------------------------------- Discounted at 3% ---------------------------------------------------------------------------------------------------------------- Responders...................................................... 74 74 148 Survivors....................................................... 9 9 18 ----------------------------------------------- Total....................................................... 83 83 166 ---------------------------------------------------------------------------------------------------------------- Discounted at 7% ---------------------------------------------------------------------------------------------------------------- Responders...................................................... 71 69 140 Survivors....................................................... 8 9 17 ----------------------------------------------- Total....................................................... 79 78 157 ---------------------------------------------------------------------------------------------------------------- Costs of COPD Treatment The Administrator estimated the medical treatment costs associated with COPD in this rulemaking, using the methods described below, to be between $1,032 and $1,930 per case in 2014. The low estimate, $1,032 per case, was based on WTC Health Program costs associated with the treatment of WTC-exacerbated COPD for the period October 1, 2013 through September 30, 2014. These medical costs included medical services only.\52\ Discounting future medical costs for the following year (2015) at 3 percent would result in $1,002 and at 7 percent in $965 per member. Discounting future medical costs for one more year (2016) at 3 percent would result in $973 and at 7 percent in $901 per member. --------------------------------------------------------------------------- \52\ Costs may be underestimated because pharmaceuticals are not included in the analysis. Although the WTC Health Program does treat patients with WTC-exacerbated COPD, the cost of pharmaceuticals for this health condition is not readily available. --------------------------------------------------------------------------- The high estimate, $1,930 per case, was based on a study by Leigh et al. [2002].\53\ The authors estimated the cost of occupational COPD by aggregating and analyzing national data sets collected by the National Center for Health Statistics, the Health Care Financing Administration, and other government agencies and private firms. They concluded that there were an estimated 2,395,650 occupational cases of COPD in 1996 that resulted in medical costs estimated at $2.425 billion. Medical costs included payments to hospitals, physicians, nursing homes, and vendors of medical supplies, including oxygen, and also included the cost of pharmaceuticals. The medical cost per case was about $1,012 in 1996 dollars or about $1,930 in 2014, after adjusting for inflation using the Medical Consumer Price Index for all urban consumers. Discounting future medical costs for the following year (2015) at 3 percent would result in $1,874 and at 7 percent in $1,804 per COPD case. Discounting future medical costs for one more year (2016) at 3 percent would result in $1,819 and at 7 percent in $1,686 per COPD case.\54\ --------------------------------------------------------------------------- \53\ Leigh JP, Romano PS, Schenker MB, Kreiss K [2002]. Costs of occupational COPD and asthma. Chest. Jan;121(1):264-272. \54\ The U.S. Preventive Services Task Force does not recommended screening for COPD. Screening for Chronic Obstructive Pulmonary Disease Using Spirometry. http://www.uspreventiveservicestaskforce.org/uspstf/uspscopd.htm. Accessed September 10, 2014. --------------------------------------------------------------------------- Table 3 below shows the net present value of the range of the medical treatment cost per COPD case for the period 2015-2016: Table 3--Present value of 2015 and 2016 Medical Treatment Cost per COPD Case in 2014 Dollars ---------------------------------------------------------------------------------------------------------------- Source Year Undiscounted Discounted at 3% Discounted at 7% ---------------------------------------------------------------------------------------------------------------- WTC Health Program.................. 2015 $1,032 $1,002 $965 2016 1,032 973 901 --------------------------------------------------------------------------- Total........................... ................. 2,064 1,975 1,866 Leigh et al. (2002)................. 2015 1,930 1,874 1,804 2016 1,930 1,819 1,686 --------------------------------------------------------------------------- Total........................... ................. 3,860 3,693 3,490 ---------------------------------------------------------------------------------------------------------------- [[Page 54758]] Costs of Acute Traumatic Injury Treatment The Administrator estimated the medical treatment costs associated with acute traumatic injury in this rulemaking using the methods described below. Because it is not possible to identify all possible types of acute traumatic injury for which a WTC responder or survivor might seek certification, we have identified several types of acute traumatic injury that may represent those types of acute traumatic injury that might be certified by the WTC Health Program. Representative examples of acute traumatic injuries include closed head injuries, burns, fractures, strains and sprains, orthopedic injuries (e.g., meniscus tear), ocular injuries, and crush injuries. The WTC Health Program estimates the cost of providing medical treatment for acute traumatic injury to be around $11,216 per case in 2014. This cost figure was based on a study by the National Council on Compensation Insurance (NCCI).\55\ The data source used in this study was NCCI's Medical Data Call (MDC). The MDC captures transaction-level detail on workers' compensation medical bills processed on or after July 1, 2010, including dates of service, charges, payments, procedure codes, and diagnosis codes; pharmaceutical costs are also included. The data used in this study were evaluated as of March 2013 for: --------------------------------------------------------------------------- \55\ Col[oacute]n D [2014]. The impact of claimant age on late- term medical costs. NCCI Research brief, October 2014. https://www.ncci.com/documents/Impact-Claimant-Age-Late-Term-Med-Costs.pdf. Accessed February 4, 2015. --------------------------------------------------------------------------- Long-term medical services provided in 2011 and 2012 (i.e., 20 to 30 years post injury) Injuries occurring between 1983 and 1990 Claimants with dates of birth between 1920 and 1970 States for which NCCI collects MDC \56\ --------------------------------------------------------------------------- \56\ AK, AL, AR, AZ, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OK, OR, RI, SC, SD, TN, UT, VA, VT, WI, and WV --------------------------------------------------------------------------- For individuals born during 1951-1970, the medical cost per case was about $11,216 in 2014 dollars, after adjusting for inflation using the Medical Consumer Price Index for all urban consumers.\57\ Discounting future medical costs for the following year (2015) at 3 percent would result in $10,890 and at 7 percent in $10,482 per acute traumatic injury case. Discounting future medical costs for one more year (2016) at 3 percent would result in $10,572 and at 7 percent in $9,796 per traumatic injury case. --------------------------------------------------------------------------- \57\ Bureau of Labor Statistics. Consumer Price Index. https://research.stlouisfed.org/fred2/series/CPIMEDSL/downloaddata?cid=32419. Accessed November 5, 2014. --------------------------------------------------------------------------- Table 4 below shows the present value of the range of the medical treatment cost per traumatic injury case for the period 2015-2016: Table 4--Present Value of 2015 and 2016 Medical Treatment Cost per Acute Traumatic Injury Case in 2014 Dollars ---------------------------------------------------------------------------------------------------------------- Source Year Undiscounted Discounted at 3% Discounted at 7% ---------------------------------------------------------------------------------------------------------------- NCCI (2014)......................... 2015 $11,216 $10,890 $10,482 2016 11,216 10,572 9,796 --------------------------------------------------------------------------- Total........................... ................. 22,432 21,462 20,278 ---------------------------------------------------------------------------------------------------------------- Summary of Costs This rulemaking is estimated to cost the WTC Health Program between $5,124,477 and $9,350,966 for the years 2015 and 2016.\58\ The analysis above offers an assumption about the number of individuals who might enroll in the WTC Health Program and estimates the number of new-onset COPD and acute traumatic injury cases and the resulting estimated treatment costs to the WTC Health Program. For the purpose of computing the treatment costs for new-onset COPD and acute traumatic injury, the Administrator assumed that all of the individuals who are diagnosed with either condition will be certified by the WTC Health Program for treatment and monitoring services. In the calculations found in Tables 5 and 6, below, estimated treatment costs were applied to the estimated number of cases of new-onset COPD and acute traumatic injuries. We assumed that 9 percent of new-onset COPD costs and 12 percent of acute traumatic injury costs for responders may be covered by workers' compensation each year; \59\ accordingly, we adjusted only the responder estimates to clarify that 91 percent of COPD costs and 88 percent of acute traumatic injury costs will be paid by the WTC Health Program.\60\ This analysis does not include administrative costs associated with certifying additional diagnoses of new-onset COPD or acute traumatic injuries 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). --------------------------------------------------------------------------- \58\ The low cost estimate reflects the low COPD treatment cost estimate using WTC Health Program data, discounted at 7 percent, from Table 5 and the acute traumatic injury treatment cost estimate, discounted at 7 percent, from Table 6. The high cost estimate reflects the high COPD treatment cost estimate using data from Leigh et al. (2002), discounted at 3 percent, from Table 5 and the acute traumatic injury treatment cost estimate, discounted at 3 percent, from Table 6. \59\ See: WTC Health Program. Policy and procedures for recoupment and coordination of benefits: workers' compensation payment. http://www.cdc.gov/wtc/pdfs/WTCHP-PP-Recoupment-WComp-16-Dec-13.pdf. \60\ Workers' compensation rates are derived from WTC Health Program data. --------------------------------------------------------------------------- Since the implementation of provisions of the Affordable Care Act on January 1, 2014, all of the members and future members are 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 through 2016 are considered transfers. Tables 5 and 6 describe the estimated allocation of WTC Health Program transfer payments. [[Page 54759]] Table 5--Present Value of 2015 and 2016 Medical Treatment Cost for New-Onset COPD Cases in 2014 Dollars ---------------------------------------------------------------------------------------------------------------- Source (costs) Year Undiscounted Discounted at 3% Discounted at 7% ---------------------------------------------------------------------------------------------------------------- Responders ---------------------------------------------------------------------------------------------------------------- WTC Health Program................ 2015 $1,032 * 2,013 * .91 $1,002 * 1,954 * .91 $965 * 1,881 * .91 = = $1,890,449. = $1,781,696. $1,651,800 2016 $1,032 * 2,125 * .91 $973 * 2,003 * .91 = $901 * 1,856 * .91 = = $1,995,630. $1,773,516. $1,521,753 ---------------------------------------------------------------------------------------------------------------- Survivors ---------------------------------------------------------------------------------------------------------------- 2015 $1,032 * 291 = $1,002 * 283 = $965 * 272 = $262,480 $300,312. $283,566. 2016 $1,032 * 339 = $973 * 320 = $311,360 $901 * 296 = $266,696 $349,848. -------------------------------------------------------------------- Total $4,536,239........... $4,150,138........... $3,702,729 ---------------------------------------------------------------------------------------------------------------- Responders ---------------------------------------------------------------------------------------------------------------- Leigh et al. (2002)............... 2015 $1,930 * 2,013 * .91 $1,874 * 1,954 * .91 $1,804 * 1,881 * .91 = $3,535,432. = $3,332,234. = $3,087,925 2016 $1,930 * 2,125 * .91 $1,819 * 2,003 * .91 $1,686 * 1,856 * .91 = $3,732,138. = $3,315,546. = $2,847,587 ---------------------------------------------------------------------------------------------------------------- Survivors ---------------------------------------------------------------------------------------------------------------- 2015 $1,930 * 291 = $1,874 * 283 = $1,804 * 272 = $561,630. $530,342. $490,688 2016 $1,930 * 339 = $1,819 * 320 = $1,686 * 296 = $654,270. $582,080. $499,056 -------------------------------------------------------------------- Total $8,483,470........... $7,760,202........... $6,925,256 ---------------------------------------------------------------------------------------------------------------- Table 6--Present Value of 2015 and 2016 Medical Treatment Cost for Acute Traumatic Injury Cases in 2014 Dollars ---------------------------------------------------------------------------------------------------------------- Source (costs) Year Undiscounted Discounted at 3% Discounted at 7% ---------------------------------------------------------------------------------------------------------------- Responders ---------------------------------------------------------------------------------------------------------------- NCCI (2014)....................... 2015 $11,216 * 76 * .88 = $10,890 * 74 * .88 = $10,482 * 71 * .88 = $750,126. $709,157. $654,915 2016 $11,216 * 79 * .88 = $10,572 * 74 * .88 = $9,796 * 69 * .88 = $779,736. $688,449. $594,813 ---------------------------------------------------------------------------------------------------------------- Survivors ---------------------------------------------------------------------------------------------------------------- 2015 $11,216 * 9 = $10,890 * 9 = $98,010 $10,482 * 8 = $83,856 $100,944. 2016 $11,216 * 10 = $10,572 * 9 = $95,148 $9,796 * 9 = $88,164 $112,160. -------------------------------------------------------------------- Total $1,742,966........... $1,590,764........... $1,421,748 ---------------------------------------------------------------------------------------------------------------- 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 new-onset COPD or acute traumatic injury patients treated through the WTC Health Program, compared to no treatment by the Program. The Administrator does not have information on the health of the population that may have experienced 9/11 exposures and is not currently enrolled in the WTC Health Program. However, the Administrator assumes that all unenrolled responders and survivors are now covered by health insurance (due to the ACA) and may be receiving treatment outside the WTC Health Program. Although the Administrator cannot quantify the benefits associated with the WTC Health Program, members with new-onset COPD or acute traumatic injury would have improved access to care and thereby the Program should produce better treatment outcomes than in its absence. Under other insurance plans, patients may have deductibles and copays, which impact access to care and timeliness of care. WTC Health Program members who are certified for these conditions would have first-dollar coverage and, therefore, are likely to seek care sooner when indicated, resulting in improved treatment outcomes. Limitations The analysis presented here was limited by the dearth of verifiable data on the new-onset COPD and acute traumatic injury status of responders and survivors who have yet to apply for enrollment in the WTC Health Program. Because of the limited data, the Administrator was not able to estimate benefits in terms of averted healthcare costs. Nor was the Administrator able to estimate indirect costs such as averted absenteeism, short and long-term disability, and productivity losses averted due to premature mortality. B. Regulatory Flexibility Act The Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq., requires each [[Page 54760]] agency to consider the potential impact of its regulations on small entities including small businesses, small governmental units, and small not-for-profit organizations. The Administrator 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.). 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. This rule does not contain any information collection requirements; thus, HHS has determined that the PRA does not apply to this rule. D. Small Business Regulatory Enforcement Fairness Act As required by Congress under the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801 et seq.), HHS will report the promulgation of this rule to Congress prior to its effective date. E. Unfunded Mandates Reform Act of 1995 Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531 et seq.) directs agencies to assess the effects of Federal regulatory actions on State, local, and Tribal governments, and the private sector ``other than to the extent that such regulations incorporate requirements specifically set forth in law.'' For purposes of the Unfunded Mandates Reform Act, this proposed rule does not include any Federal mandate that may result in increased annual expenditures in excess of $100 million in 1995 dollars by State, local or Tribal governments in the aggregate, or by the private sector. 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). 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) The Administrator has reviewed this proposed rule in accordance with Executive Order 13132 regarding federalism, and has determined that it does not have ``federalism implications.'' The rule does not ``have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.'' H. Executive Order 13045 (Protection of Children from Environmental Health Risks and Safety Risks) In accordance with Executive Order 13045, the Administrator has evaluated the environmental health and safety effects of this proposed rule on children. The Administrator has determined that the rule would have no environmental health and safety effect on children. I. Executive Order 13211 (Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use) In accordance with Executive Order 13211, the Administrator has evaluated the effects of this proposed rule on energy supply, distribution or use, and has determined that the rule will not have a significant adverse effect. J. Plain Writing Act of 2010 Under Public Law 111-274 (October 13, 2010), executive Departments and Agencies are required to use plain language in documents that explain to the public how to comply with a requirement the Federal Government administers or enforces. The Administrator has attempted to use plain language in promulgating the proposed rule consistent with the Federal Plain Writing Act guidelines. Proposed Rule List of Subjects in 42 CFR Part 88 Administrative practice and procedure, Health care, Lung diseases, Mental health programs. For the reasons discussed in the preamble, the Department of Health and Human Services proposes to revise 42 CFR part 88 as follows: PART 88--WORLD TRADE CENTER HEALTH PROGRAM 0 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. 0 2. In Sec. 88.1, under the definition ``List of WTC-related health conditions,'' revise paragraph (1)(v) and add paragraph (5) to read as follows: Sec. 88.1 Definitions. * * * * * List of WTC-related health conditions * * * (1) * * * (v) WTC-exacerbated and new-onset chronic obstructive pulmonary disease (COPD). * * * * * (5) Acute traumatic injuries for those WTC responders and screening- and certified-eligible WTC survivors who received any medical treatment for such an injury on or before September 11, 2003. Acute traumatic injury means physical damage to the body caused by and occurring immediately after a one-time exposure to energy, such as heat, electricity, or impact from a crash or fall, resulting from a specific event or incident. Eligible acute traumatic injuries may include but are not limited to the following: (i) Eye injuries. (ii) Severe burns. (iii) Head trauma. (iv) Fractures. (v) Tendon tears. (vi) Complex sprains. (vii) Other similar acute traumatic injuries. * * * * * Dated: August 31, 2015. 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. 2015-22599 Filed 9-9-15; 11:15 am] BILLING CODE P
![54746 Federal Register / Vol. 80, No. 176 / Friday, September 11, 2015 / Proposed Rules
Board (NRB). However, the NRB’s PM2.5, 2008 Pb, 2008 ozone, 2010 NO2, • Is not subject to requirements of
functions are purely regulatory, and 2010 SO2 NAAQS. Section 12(d) of the National
advisory, and policy-making. Under Technology Transfer and Advancement
VI. Incorporation by Reference
Wis. Stats. 15.05, the administrative Act of 1995 (15 U.S.C. 272 note) because
powers and duties of the WDNR, In this rule, EPA is proposing to application of those requirements would
including issuance of permits and include in a final EPA rule regulatory be inconsistent with the CAA; and
enforcement orders, are vested in the text that includes incorporation by • Does not provide EPA with the
secretary. Under the statutes that govern reference. In accordance with discretionary authority to address, as
its operations, the NRB does not and requirements of 1 CFR 51.5, EPA is appropriate, disproportionate human
cannot approve permits or enforcement proposing to incorporate by reference health or environmental effects, using
orders. Therefore, Wisconsin has no Wis. Stats. 15.05, effective July 2, 2013, practicable and legally permissible
further obligations under section Wis. Stats. 19.45(2), effective May 11, methods, under Executive Order 12898
128(a)(1) of the CAA. 1990, and Wis. Stats. 19.46, effective (59 FR 7629, February 16, 1994).
Under section 128(a)(2) of the CAA, February 17, 2007. EPA has made, and In addition, the SIP is not approved
the head of the executive agency with will continue to make, these documents to apply on any Indian reservation land
the power to approve permits or generally available electronically or in any other area where EPA or an
enforcement orders must adequately through www.regulations.gov and/or in Indian tribe has demonstrated that a
disclose any potential conflicts of hard copy at the appropriate EPA office tribe has jurisdiction. In those areas of
interest. In Wisconsin, this power is (see the ADDRESSES section of this Indian country, the rule does not have
vested in the Secretary of the WDNR. preamble for more information). tribal implications and will not impose
Wis. Stats. 19.45(2) prevents financial substantial direct costs on tribal
VII. Statutory and Executive Order governments or preempt tribal law as
gain of any public official, which Reviews
addresses the issue of deriving any specified by Executive Order 13175 (65
significant portion of income from Under the CAA, the Administrator is FR 67249, November 9, 2000).
persons subject to permits and required to approve a SIP submission List of Subjects in 40 CFR Part 52
enforcement orders. Additionally, Wis. that complies with the provisions of the
CAA and applicable Federal regulations. Environmental protection, Air
Stats. 19.46 prevents a public official
42 U.S.C. 7410(k); 40 CFR 52.02(a). pollution control, Incorporation by
from taking actions where there is a
Thus, in reviewing SIP submissions, reference, Intergovernmental relations,
conflict of interest. As a public official
EPA’s role is to approve state choices, Lead, Nitrogen dioxide, Ozone,
under Wis. Stats. 19, the Secretary of the
provided that they meet the criteria of Particulate matter, Reporting and
WDNR is subject to these ethical
the CAA. Accordingly, this action recordkeeping requirements, Sulfur
obligations. As requested in WDNR’s
merely approves state law as meeting oxides.
submission, EPA is proposing to
incorporate Wis. Stats. 15.05, 19.45(2), Federal requirements and does not Dated: August 28, 2015.
and 19.46 into Wisconsin’s SIP. EPA impose additional requirements beyond Susan Hedman,
proposes that these statutes satisfy all those imposed by state law. For that Regional Administrator, Region 5.
requirements under section 128 of the reason, this action: [FR Doc. 2015–22713 Filed 9–10–15; 8:45 am]
CAA. • Is not a significant regulatory action BILLING CODE 6560–50–P
subject to review by the Office of
B. Section 110(a)(2)(E)(ii) Management and Budget under
Section 110(a)(2)(E)(ii) of the CAA Executive Orders 12866 (58 FR 51735,
DEPARTMENT OF HEALTH AND
also requires each SIP to contain October 4, 1993) and 13563 (76 FR 3821,
HUMAN SERVICES
provisions that comply with the state January 21, 2011);
board requirements of section 128 of the • Does not impose an information 42 CFR Part 88
CAA. collection burden under the provisions
of the Paperwork Reduction Act (44 [Docket No. CDC–2015–0063, NIOSH–287]
In its submittal dated July 2, 2015,
WDNR requested that Wis. Stats. 15.05, U.S.C. 3501 et seq.); RIN 0920–AA61
19.45(2), and 19.46 be applied not only • Is certified as not having a
to obligations under section 128 of the significant economic impact on a World Trade Center Health Program;
CAA, but also to infrastructure SIP substantial number of small entities Addition of New-Onset Chronic
requirements for the 1997 ozone, 1997 under the Regulatory Flexibility Act (5 Obstructive Pulmonary Disease and
PM2.5, 2006 PM2.5, 2008 Pb, 2008 ozone, U.S.C. 601 et seq.); Acute Traumatic Injury to the List of
2010 NO2, and 2010 SO2 NAAQS. EPA • Does not contain any unfunded WTC-Related Health Conditions
therefore proposes that Wisconsin has mandate or significantly or uniquely AGENCY: Centers for Disease Control and
met the infrastructure SIP requirements affect small governments, as described Prevention, HHS.
of this portion of section 110(a)(2)(E)(ii) in the Unfunded Mandates Reform Act
ACTION: Notice of proposed rulemaking.
with respect to the 1997 ozone, 1997 of 1995 (Pub. L. 104–4);
PM2.5, 2006 PM2.5, 2008 Pb, 2008 ozone, • Does not have Federalism SUMMARY: The World Trade Center
2010 NO2, and 2010 SO2 NAAQS. implications as specified in Executive (WTC) Health Program, at the direction
Order 13132 (64 FR 43255, August 10, of the Administrator, conducted a
V. What Action is EPA Taking?
rmajette on DSK7SPTVN1PROD with PROPOSALS
1999); review of published studies regarding
EPA is proposing to incorporate Wis. • Is not an economically significant potential evidence of chronic
Stats. 15.05, 19.45(2), and 19.46 into regulatory action based on health or obstructive pulmonary disease (COPD)
Wisconsin’s SIP. EPA is further safety risks subject to Executive Order and acute traumatic injury among
proposing to approve these submissions 13045 (62 FR 19885, April 23, 1997); individuals who were responders to or
as meeting CAA obligations under • Is not a significant regulatory action survivors of the September 11, 2001,
section 128, as well as 110(a)(2)(E)(ii) subject to Executive Order 13211 (66 FR terrorist attacks. The Administrator of
for the 1997 ozone, 1997 PM2.5, 2006 28355, May 22, 2001); the WTC Health Program found that
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![Federal Register / Vol. 80, No. 176 / Friday, September 11, 2015 / Proposed Rules 54747
these studies provided substantial C. Administrator’s Determination rulemaking is estimated to cost the WTC
support for a causal relationship Concerning Acute Traumatic Injury Health Program between $5,124,477 and
between the health conditions and 9/11 VI. Effects of Rulemaking on Federal $9,350,966 in 2015 and 2016. All of the
Agencies
exposures. As a result, the costs to the WTC Health Program are
VII. Summary of Proposed Rule
Administrator has determined to VIII. Regulatory Assessment Requirements transfers. Benefits to current and future
publish a proposed rule to add new- A. Executive Order 12866 and Executive WTC Health Program members may
onset COPD and to add acute traumatic Order 13563 include improved access to care and
injury to the List of WTC-Related Health B. Regulatory Flexibility Act better treatment outcomes than in the
Conditions eligible for treatment C. Paperwork Reduction Act absence of Program coverage.
coverage in the WTC Health Program. D. Small Business Regulatory Enforcement
Fairness Act II. Public Participation
DATES: Comments must be received by E. Unfunded Mandates Reform Act of 1995
October 26, 2015. Interested persons or organizations
F. Executive Order 12988 (Civil Justice) are invited to participate in this
ADDRESSES: Written Comments: You G. Executive Order 13132 (Federalism)
H. Executive Order 13045 (Protection of
rulemaking by submitting written views,
may submit comments by any of the opinions, recommendations, and/or
following methods: Children from Environmental Health
Risks and Safety Risks) data. Comments are invited on any topic
• Federal eRulemaking Portal: http:// related to this proposed rule. The
I. Executive Order 13211 (Actions
www.regulations.gov. Follow the Concerning Regulations that Administrator invites comments
instructions for submitting comments. Significantly Affect Energy Supply, specifically on the following questions
• Mail: NIOSH Docket Office, 1090 Distribution, or Use) related to this rulemaking:
Tusculum Avenue, MS C–34, J. Plain Writing Act of 2010 1. Is September 11, 2003 an
Cincinnati, OH 45226–1998. appropriate deadline by which an
Instructions: All submissions received I. Executive Summary
individual must have received initial
must include the agency name (Centers A. Purpose of Regulatory Action medical treatment for an acute traumatic
for Disease Control and Prevention, This rulemaking is being conducted injury?
HHS) and docket number (CDC–2015– in order to add new-onset COPD and 2. Is there evidence of acute traumatic
0063) or Regulation Identifier Number acute traumatic injury to the List of injuries that occurred as a result of the
(0920–AA61) for this rulemaking. All WTC-Related Health Conditions (List). September 11, 2001, terrorist attacks
relevant comments, including any Following requests by the directors of that would not be covered by the
personal information provided, will be the WTC Health Program Clinical proposed definition? What are the types
posted without change to http:// Centers of Excellence (CCE) and Data of long-term consequences or medically
www.regulations.gov. For detailed Centers to the WTC Health Program to associated health conditions that result
instructions on submitting public consider adding the two conditions,1 from the treatment or progression of
comments, see the ‘‘Public the Administrator conducted literature acute traumatic injuries like those
Participation’’ heading of the reviews regarding COPD and acute sustained on or after September 11,
SUPPLEMENTARY INFORMATION section of traumatic injury among 9/11 responders 2001?
this document. and survivors. Based on the findings of 3. Are data available on the chronic
Docket: For access to the docket to those reviews, he determined that the care needs of individuals who suffered
read background documents, go to evidence for causal relationships acute traumatic injuries during the
http://www.regulations.gov. between 9/11 exposures and COPD and September 11, 2001, terrorist attacks,
FOR FURTHER INFORMATION CONTACT: acute traumatic injury, respectively, and its aftermath that the Administrator
Rachel Weiss, Program Analyst, 1090 provides bases for the addition of both can use to estimate the number of
Tusculum Ave, MS: C–46, Cincinnati, health conditions. The Administrator current and future WTC Health Program
OH 45226; telephone (855)818–1629 proposes adding new-onset COPD and members who may seek certification of
(this is a toll-free number); email acute traumatic injury to the List. WTC-related acute traumatic injuries as
NIOSHregs@cdc.gov. well as treatment costs?
B. Summary of Major Provisions
SUPPLEMENTARY INFORMATION: 4. Are data available on the
This rule proposes the addition of prevalence and cost estimates for new-
Table of Contents new-onset COPD and acute traumatic onset COPD?
I. Executive Summary injury to the List of WTC-Related Health Comments received, including
A. Purpose of Regulatory Action Conditions in 42 CFR 88.1. As a result, attachments and other supporting
B. Summary of Major Provisions these conditions will be eligible for materials, are part of the public record
C. Costs and Benefits treatment and monitoring coverage by and subject to public disclosure. Do not
II. Public Participation the WTC Health Program. include any information in your
III. Background
A. WTC Health Program Statutory C. Costs and Benefits comment or supporting materials that
Authority you consider confidential or
The proposed addition of new-onset inappropriate for public disclosure.
B. Methods Used by the Administrator to COPD and acute traumatic injury by this
Determine Whether to Add Non-Cancer Comments submitted electronically or
Health Conditions to the List of WTC- 1 Crane M, Lucchini R, Moline J, Prezant D, Kelly
by mail should be titled ‘‘Docket No.
Related Health Conditions K, Udasin I, Luft B, Harrison D, Reibman J,
CDC–2015–0063’’ and should identify
IV. COPD Markowitz S [2014]. Letter from CCE and Data the author(s) and contact information in
rmajette on DSK7SPTVN1PROD with PROPOSALS
A. CCE and Data Center Request to Center Directors to Dori Reissman and John Halpin, case clarification is needed. Electronic
Consider Adding New-Onset COPD WTC Health Program regarding ‘‘Musculoskeletal and written comments can be submitted
B. Literature Review Conditions;’’ and Crane M, Lucchini R, Moline J,
Prezant D, Kelly K, Udasin I, Luft B, Harrison D, to the addresses provided in the
C. Administrator’s Determination
and Reibman J [2014]. Letter from CCE and Data ADDRESSES section, above. All
Concerning New-Onset COPD
Center Directors to Dori Reissman and John Halpin, communications received on or before
V. Acute Traumatic Injury WTC Health Program regarding ‘‘Rationale for the
A. CCE and Data Center Request to continued certification of COPD as a World Trade
the closing date for comments will be
Consider Adding Acute Traumatic Injury Center related and covered condition.’’ These letters fully considered by the Administrator of
B. Literature Review are included in the docket for this rulemaking. the WTC Health Program.
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![54748 Federal Register / Vol. 80, No. 176 / Friday, September 11, 2015 / Proposed Rules
The Administrator has determined WTC-Related Health Conditions in evaluating associations between the
that good cause exists to extend the § 88.1. Pursuant to sec. 3312(a)(6)(D) of health condition of interest and 9/11
traditional 30-day comment period to 45 Title XXXIII of the PHS Act, the agents.8 If that additional assessment
days. The comment period is extended Administrator is required to publish a establishes substantial support for a
to provide interested parties, including notice of proposed rulemaking and causal relationship between a 9/11 agent
peer-reviewers, adequate time to review allow interested parties to comment on or agents and the health condition, the
the proposed rule and supporting the proposed rule. health condition may be added to the
scientific literature and to submit The Administrator has established a List.
written comments to the docket. methodology for evaluating whether to
add non-cancer health conditions to the IV. COPD
III. Background List of WTC-Related Health Conditions; A. CCE and Data Center Request to
A. WTC Health Program Statutory this methodology is published online in Consider Adding New-Onset COPD
Authority the Policies and Procedures section of On May 13, 2014, the Administrator
the WTC Health Program Web site.5 The received a letter from the directors of
Title I of the James Zadroga 9/11 Administrator will direct the WTC
Health and Compensation Act of 2010 the WTC Health Program Clinical
Health Program Associate Director for Centers of Excellence (CCEs) and Data
(Pub. L. 111–347), amended the Public Science (ADS) to conduct a review of
Health Service Act (PHS Act) to add Centers, asking that the Administrator
the scientific literature to determine if consider all requests for certification of
Title XXXIII,2 establishing the WTC the available scientific information has
Health Program within the Department COPD.9 The Zadroga Act and WTC
the potential to provide a basis for a Health Program regulations identify
of Health and Human Services (HHS). decision on whether to add the
The WTC Health Program provides ‘‘WTC-exacerbated chronic obstructive
condition to the List. The literature pulmonary disease (COPD)’’ as a
medical monitoring and treatment review will include published, peer-
benefits to eligible firefighters and covered health condition.10 However,
reviewed direct observational and/or the CCE and Data Center directors
related personnel, law enforcement epidemiological studies about the health
officers, and rescue, recovery, and requested that the Administrator
condition among 9/11-exposed determine that COPD is a certifiable
cleanup workers who responded to the populations. The studies will be
September 11, 2001, terrorist attacks in WTC condition, regardless of the date of
reviewed for their relevance, quantity, onset.11 In order to certify all cases of
New York City, at the Pentagon, and in and quality to provide a basis for
Shanksville, Pennsylvania (responders), COPD, including cases diagnosed after
deciding whether to propose adding the the September 11, 2001, terrorist
and to eligible persons who were health condition to the List. Where the
present in the dust or dust cloud on attacks, new-onset COPD would need to
available evidence has the potential to be added to the List of WTC-Related
September 11, 2001 or who worked, provide a basis for a decision, the ADS
resided, or attended school, childcare, Health Conditions. The Administrator
will further assess the scientific and directed the ADS to initiate a review of
or adult daycare in the New York City medical evidence to determine whether
disaster area (survivors). research regarding COPD in 9/11-
a causal relationship between 9/11 exposed populations in order to
All references to the Administrator of exposures and the health condition is
the WTC Health Program determine whether there was support
supported. A health condition may be
(Administrator) in this notice mean the for such an addition.
added to the List if published, peer-
Director of the National Institute for reviewed direct observational or B. Literature Review
Occupational Safety and Health epidemiologic studies provide In accordance with the established
(NIOSH) or his or her designee. Section substantial support 6 for a causal methodology for the addition of non-
3312(a)(6) of the PHS Act requires the relationship between 9/11 exposures cancers to the List, the Administrator
Administrator to conduct rulemaking to and the health condition in 9/11- charged the ADS with conducting a
propose the addition of a health exposed populations. If only review of the relevant, peer-reviewed,
condition to the List of WTC-Related epidemiologic studies are available and published studies of 9/11-exposed
Health Conditions (List) codified in 42 they provide only modest support 7 for populations.
CFR 88.1. a causal relationship between 9/11 Because definitions of COPD vary
B. Methods Used by the Administrator exposures and the health condition, the among authorities, the ADS first had to
to Determine Whether to Add Non- Administrator may then evaluate identify the best definition for the
Cancer Health Conditions to the List of additional published, peer-reviewed purposes of the WTC Health Program.
WTC-Related Health Conditions epidemiologic studies, conducted
among non-9/11-exposed populations, 8 9/11 agents are chemical, physical, biological, or
Consideration of an addition to the other agents or hazards reported in a published,
List of WTC-Related Health Conditions 5 Howard J, Administrator of the WTC Health peer-reviewed exposure assessment study of
(List) may be initiated at the Program. Policy and procedures for adding non- responders or survivors who were present in the
cancer conditions to the List of WTC-Related Health New York City disaster area, or at the Pentagon site,
Administrator’s discretion 3 or following or the Shanksville, Pennsylvania site as those
Conditions. October 21, 2014. http://www.cdc.gov/
receipt of a petition by an interested wtc/pdfs/WTCHP_PP_Adding_NonCancers_21_ locations are defined in 42 CFR 88.1.
party.4 Under 42 CFR 88.17, the Oct_2014.pdf. 9 See: Crane M, Lucchini R, Moline J, Prezant D,
Administrator has established a process 6 The substantial evidence standard is met when Kelly K, Udasin I, Luft B, Harrison D, Reibman J
by which health conditions may be the Program assesses all of the available, relevant [2014]. Rationale for the continued certification of
rmajette on DSK7SPTVN1PROD with PROPOSALS
information and determines with high confidence COPD as a World Trade Center related and covered
considered for addition to the List of that the evidence supports its findings regarding a condition. Letter from WTC Health Program Data
causal association between the 9/11 exposure(s) and Center and Clinical Centers of Excellence Directors
2 Title XXXIII of the PHS Act is codified at 42 to Drs. Dori Reissman and John Halpin, WTC Health
the health condition.
U.S.C. 300mm to 300mm–61. Those portions of the 7 The modest evidence standard is met when the Program. This letter is included in the docket for
Zadroga Act found in Titles II and III of Public Law Program assesses all of the available, relevant this rulemaking.
111–347 do not pertain to the WTC Health Program information and determines with moderate 10 PHS Act, sec. 3312(a)(3)(A)(v); 42 CFR 88.1.
and are codified elsewhere. confidence that the evidence supports its findings 11 COPD letter from WTC Health Program CCE
3 PHS Act, sec. 3312(a)(6)(A); 42 CFR 88.17(b).
regarding a causal association between the 9/11 and Data Center Directors to Drs. Dori Reissman and
4 PHS Act, sec. 3312(a)(6)(B); 42 CFR 88.17(a). exposure(s) and the health condition. John Halpin, WTC Health Program at 8.
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![Federal Register / Vol. 80, No. 176 / Friday, September 11, 2015 / Proposed Rules 54749
The ADS looked to the Global Initiative or irreversible.15 While asthma is not respiratory symptomatology and
for Chronic Obstructive Lung Disease included under the term COPD, people objective measurements of airways
(GOLD), a collaboration between the with asthma may develop COPD over obstruction, such as pre- and post-9/11
National Heart, Lung, and Blood time.16 spirometry with bronchodilator
Institute of the National Institutes of Diagnosis of COPD requires the use of administration or IOS, were found to
Health and the World Health a spirometry test, which measures how exhibit potential support for an addition
Organization as a point of reference. much and how quickly an individual recommendation. Quality was assessed
GOLD defines COPD as persistent inhales and exhales air from his or her by the presence or absence of major
airflow limitation that is usually lungs. The diagnosis of COPD is limitations, such as small size or poor
progressive and associated with an confirmed by a spirometry test comparability of study groups; use of
demonstrating poorly-reversible or unreliable or invalid measurement
enhanced chronic inflammatory
irreversible airways obstruction (i.e., the instruments; and if little or no attention
response in the airways and the lung to
proportion of vital capacity that an was given to key confounders which
noxious particles or gases.12 COPD is an individual is able to expire in the first would call into question the validity of
umbrella term that encompasses those second of expiration [FEV1/FVC or the study results. Based on these
pulmonary conditions exhibiting FEV1%] is below 70 percent) after use criteria, the ADS found six relevant
chronic inflammation of the airways, of a bronchodilator. Although papers which exhibited potential to
lung tissue, and pulmonary blood spirometry is the standard diagnostic provide a basis for a decision regarding
vessels and persistent airflow limitation: test for COPD, in some circumstances, whether to propose the addition of new-
A combination of large and small impulse oscillometry (IOS) can be onset COPD to the List. The six papers
airways disease (obstructive chronic complementary to spirometry, are summarized below.
bronchitis 13 and obstructive especially in patients at advanced age Weiden et al. [2010] 19 sought to
bronchiolitis, respectively) and and with physical or mental disorders determine the pathophysiologic basis
parenchymal destruction who cannot be diagnosed through for observed reductions in lung function
(emphysema).14 According to GOLD, the spirometry. IOS assesses airway among 1,720 Fire Department of New
three principal symptoms of COPD are resistance and frequency dependence of York (FDNY) rescue workers
dyspnea (shortness of breath), chronic resistance (FDR). FDR provides a (firefighters and emergency medical
cough, and sputum production; the measure of nonuniformity of airflow service personnel) who presented for
most common early symptom is distribution, which may reflect regional pulmonary evaluation between
dyspnea on exertion (DOE). COPD functional abnormalities in the distal September 12, 2001 and March 10,
should always be considered when airways not captured by the spirometry 2008. Exposure intensity was
these lower respiratory symptoms and test. categorized based on first arrival time at
history of exposure to risk factors for the In accordance with the GOLD the WTC site as follows: High exposure
disease are present. Because many of the definition, described above, the ADS if they arrived during the morning of
initiated a literature search for ‘‘chronic September 11, 2001, intermediate
symptoms of COPD are similar to
obstructive pulmonary disease,’’ exposure if they arrived after the
asthma symptoms, both conditions are
‘‘chronic bronchitis,’’ ‘‘pulmonary morning of September 11, 2001, but
classified as obstructive airways
emphysema,’’ ‘‘pulmonary function within the first 2 days, and low
diseases (OAD). The airway obstruction decline,’’ ‘‘respiratory insufficiency,’’ exposure if they arrived between days 3
in asthma is usually reversible after ‘‘airways obstruction,’’ and ‘‘airflow and 14. Pre-9/11 spirometry results were
bronchodilator therapy, whereas the limitation.’’ 17 The literature search available for 92 percent of participants.
obstruction in COPD is poorly-reversible yielded 108 study citations; the Researchers obtained 919 full
associated study abstracts were pulmonary function tests
12 Global Initiative for Chronic Obstructive Lung
reviewed for relevance to 9/11-exposed (bronchodilator response, lung volumes,
Disease (GOLD), Global strategy for the diagnosis,
management, and prevention of chronic obstructive
populations.18 Of the 108 citations diffusing capacity); 1,219 methacholine
pulmonary disease, updated 2014. http:// identified, 36 were determined to be challenge tests to screen for asthma; and
www.goldcopd.org/uploads/users/files/GOLD_ relevant epidemiologic studies of 9/11- 982 high-resolution computed
Report_2014_Jan23.pdf. exposed populations. Relevant papers tomography (HRCT) scans, allowing
13 Chronic bronchitis is defined by the presence
were then further reviewed for their them to report correlations between
of a productive cough of more than 3 months’
duration for more than two successive years. It quality and potential to provide a basis physiologic and radiographic measures.
becomes obstructive chronic bronchitis if for deciding whether to propose adding All physiologic tests pointed to airway
spirometric evidence of airflow obstruction the health condition to the List of WTC- obstruction with air trapping
develops. See: Chronic Obstructive Pulmonary Related Health Conditions. Only papers
Disease (COPD) [2014]. In R.S. Porter et al. (Eds.),
(demonstrated by the increase in
The Merck manual of diagnosis and therapy. http://
that reported post-9/11 lower residual volume) which correlated with
www.merckmanuals.com/professional/pulmonary_ the decline in FEV1 post-9/11,
disorders/chronic_obstructive_pulmonary_disease_ 15 American Thoracic Society [1987]. Standards
bronchodilator responsiveness, and
and_related_disorders/chronic_obstructive_ for the diagnosis and care of patients with chronic
pulmonary_disease_copd.html. obstructive pulmonary disease (COPD) and asthma.
hyperreactivity. HRCT findings of
14 Emphysema is destruction of lung parenchyma Official statement of the American Thoracic Society bronchial wall thickening (which
(the portion of the lung involved in gas transfer, was adopted by the Board of Directors, November reflects proximal airway inflammation
including the alveoli, alveolar ducts and respiratory 1986. Am Rev Respir Dis. 136(1):225–244. and/or remodeling) and emphysema
16 Global Initiative for Asthma [2015]. Global
bronchioles) leading to loss of elastic recoil and loss were reported in 26 percent and 12
rmajette on DSK7SPTVN1PROD with PROPOSALS
of alveolar septa and radial airway traction, which strategy for asthma management and prevention;
increases the tendency for airway collapse. Lung updated 2015. http://www.ginasthma.org/local/ percent of the participants, respectively.
hyperinflation, airflow limitation, and air trapping uploads/files/GINA_Report_2015.pdf.
are present. See: Chronic Obstructive Pulmonary 17 Databases searched include: PubMed, Embase, 19 Weiden MD, Ferrier N, Nolan A, Rom WN,
Disease (COPD) [2014]. In R.S. Porter et al. (Eds.), CINAHL, Web of Science, Health & Safety Science Comfort A, Gustave J, Zeig-Owens R, Zheng S,
The Merck manual of diagnosis and therapy. http:// Abstracts, and Toxline. Goldring RM, Berger KI, Cosenza K, Lee R, Webber
www.merckmanuals.com/professional/pulmonary_ 18 Only epidemiologic studies of 9/11-exposed MP, Kelly KJ, Aldrich TK, Prezant D [2010].
disorders/chronic_obstructive_pulmonary_disease_ populations were considered to be relevant. Case Obstructive airways disease with air trapping
and_related_disorders/chronic_obstructive_ series and review papers were not found to be among firefighters exposed to World Trade Center
pulmonary_disease_copd.html. relevant. dust. Chest. 137(3):566–574.
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![54750 Federal Register / Vol. 80, No. 176 / Friday, September 11, 2015 / Proposed Rules
Importantly, airway abnormalities on population for individuals of a similar control subjects. IOS measurements of
CT scans also correlated with age. The highest proportion of FDNY airway resistance and FDR (indicative of
physiologic measures. The authors responders with physician-diagnosed distal airways dysfunction) were
concluded that airways injury and OAD had the lowest lung function significantly higher in cases than in
obstruction were the predominant (FEV1% predicted), indicating that 9/11 control subjects, even when spirometry
pathophysiologic characteristics among exposure had resulted in disease. The was normal. Lower respiratory
study participants. authors were unable to attribute these symptoms were found significantly
Aldrich et al. [2010] 20 evaluated the diagnoses to any other occupational associated with IOS measurements but
long-term effects of exposure to WTC exposures. not with spirometry. Both exposure
dust on FDNY members who responded Weakley et al. [2011] 22 compared the factors and IOS outcomes were
to the September 11, 2001, terrorist prevalence of self-reported post-9/11 associated with persistent symptoms,
attacks. The authors analyzed the physician-diagnosed respiratory but exposure was not associated with
pulmonary function (FEV1) of both conditions (sinusitis, asthma, COPD/ IOS outcomes in the absence of
active and retired FDNY rescue workers emphysema, and bronchitis) in 9/11- symptoms. Certain exposure factors,
on the basis of spirometry routinely exposed FDNY firefighters to the including dust cloud density, smoke at
performed at intervals of 12 to 18 prevalence in demographically similar home or work, and dust at home or
months from March 12, 2000 to National Health Interview Survey work, were the strongest predictors of
September 11, 2008. The authors (NHIS) participants by year. The authors case status. The authors concluded that
observed a large decline in FEV1 values analyzed 45,988 questionnaires the association between post-9/11 onset
at 6 months and 12 months after completed by 10,999 firefighters from of lower respiratory symptoms and lung
September 11, 2001, especially among October 2001 to September 2010. They function abnormalities detected by
the firefighters with the heaviest dust reported higher rates of respiratory spirometry and IOS several years later
exposure (those arriving at the WTC site diagnoses in 9/11-exposed firefighters were indicative of persistent airway
on the morning of September 11, 2001). compared to the U.S. male general disease with distal airways dysfunction
After the initial decline in the first year, population, regardless of smoking as a contributing mechanism for these
the adjusted FEV1 continued to decline status. Prevalence ratios, comparing symptoms.
in smokers and non-smokers with little FDNY to NHIS rates, were highest for In a follow-up to the Friedman study
or no recovery in lung function during COPD/emphysema and bronchitis. reviewed above, Maslow et al. [2012] 24
the subsequent 6 years. The authors Because of the decrease in structural assessed associations between
concluded that the large decline in fires, improvement in personal repeatedly reported lower respiratory
FEV1 after September 11, 2001, was protective equipment, and the decline symptoms and detailed measures of
indicative of airways injury due to 9/11 in smoking rates among firefighters, the both acute and chronic 9/11-related
exposures. authors discounted normal firefighting exposures. Acute exposures involved
Webber et al. [2011] 21 examined the activities as the cause of the increase in contact with the dust cloud created by
prevalence of physician-diagnosed respiratory diagnoses. the towers’ collapse. Chronic factors
respiratory conditions in FDNY Friedman et al. [2011] 23 also were based on conditions in the home
members up to 9 years after rescue/ examined the relationship between 9/11 or work site through December 31, 2001,
recovery efforts in the New York City exposures, post-9/11 lower respiratory such as the extent of dust coverage; the
disaster area. The authors reviewed self- symptoms, and pulmonary function in a duration of detectable smoke, fumes,
reported physician diagnoses of asthma, nested case-control study of exposed and other odors; and whether the
chronic bronchitis, COPD/emphysema, survivors 7–8 years after September 11, participant engaged in or was exposed
and sinusitis from the most recent 2001. The cases examined in the study to cleaning. The authors concluded that
physical health survey conducted by the were 274 WTC Health Registry both acute and chronic exposures to the
FDNY Bureau of Health Services and participants who reported post-9/11 events of 9/11 were independently
physician diagnoses obtained from onset of a lower respiratory symptom. associated, often in a dose-dependent
FDNY electronic medical records. The One-third of the cases further reported manner, with lower respiratory
study population consisted of 10,943 post-9/11 physician diagnoses of symptoms reported 2 to 3 years and
firefighters and EMS workers who first asthma, chronic bronchitis, chronic again 5 to 6 years after September 11,
arrived at the site within 2 weeks of the obstructive pulmonary disease, or 2001 by individuals who lived and
terrorist attacks. All participants were emphysema. Registry participants worked in the WTC area.
free of COPD and emphysema before without lower respiratory symptoms or
September 11, 2001, and less than 1 inhaler use and no current or past lung C. Administrator’s Determination
percent had asthma. The authors found disease were used as control subjects. Concerning New-Onset COPD
the prevalence rates of both self- Only never-smokers participated in this The ADS assessed each of the six
reported and physician diagnoses of study. Pulmonary function was assessed studies described above according to the
OAD, i.e., asthma, chronic bronchitis, by spirometry and IOS. A higher methodology established by the
COPD/emphysema, and sinusitis were proportion of abnormal spirometry Administrator. The studies were
elevated, exceeding rates in the general results (obstructive and restrictive assessed for relevance, quality, bias, and
patterns) was found among cases than confounding by applying criteria
20 Aldrich TK, Gustave J, Hall CB, Cohen HW,
extrapolated from the Bradford Hill
Webber MP, Zeig-Owens R, Cosenza K, 22 Weakley J, Webber MP, Gustave J, Kelly K,
criteria.25
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Christodoulou V, Glass L, Al-Othman F, Weiden Cohen HW, Hall CB, Prezant DJ [2011]. Trends in
MD, Kelly KJ, Prezant D [2010]. Lung function in respiratory diagnoses and symptoms of firefighters
rescue workers at the World Trade Center after 7 exposed to the World Trade Center disaster: 2005– 24 Maslow CB, Friedman SM, Pillai PS, Reibman
years. N Engl J Med. 362(14):1263–1272. 2010. Prev Med. 53(6):364–369. J, Berger KI, Goldring R, Stellman SD, Farfel M
21 Webber MP, Glaser MS, Weakley J, Soo J, Ye 23 Friedman SM, Maslow CB, Reibman J, Pillai [2012]. Chronic and acute exposures to the world
F, Zeig-Owens R, Weiden MD, Nolan A, Aldrich PS, Goldring RM, Farfel MR, Stellman SD, Berger trade center disaster and lower respiratory
TK, Kelly K, Prezant D [2011]. Physician-diagnosed KI [2011]. Case-control study of lung function in symptoms: Area residents and workers. Am J Public
respiratory conditions and mental health symptoms World Trade Center Health Registry area residents Health. 102(6):1186–1194.
7–9 years following the World Trade Center and workers. Am J Respir Crit Care Med. 25 Criteria extrapolated from Bradford Hill criteria
disaster. Am J Ind Med. 54(9):661–671. 184(5):582–589. include: (i) Strength of the association between a
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![Federal Register / Vol. 80, No. 176 / Friday, September 11, 2015 / Proposed Rules 54751
First, the studies were assessed for persistent respiratory injury since response relationships between 9/11
strength of the association between 9/11 exposure to the WTC had resulted in exposures and the health condition.
exposures and a health condition obstructive airways disease. A major Newly developed lower respiratory
(including the magnitude of the effect limitation of both studies was the use of symptoms and persistent pulmonary
and statistical significance). Weiden et self-reported diagnoses, including function abnormalities suggestive of
al. reported statistically significant diagnoses made by any physician airways injury and obstruction were
longitudinal declines in FEV1, greater (FDNY or otherwise) and self-diagnoses, significantly associated with 9/11
than expected by age or weight gain, which may have over-inflated the exposure in the FDNY studies, even
among firefighters with documented prevalence rates. This limitation is a after accounting for cigarette smoking.
high levels of exposure. Aldrich et al. concern, especially for COPD/ [Weiden et al.; Aldrich et al.; Webber et
reported significant substantial declines emphysema, which can be defined in a al.; Weakley et al.] Maslow et al.
in FEV1 over the first year after the variety of ways; the definition used can observed strong, significant associations
September 11, 2001, terrorist attacks have a significant impact on the and dose-response relationships
and little lung function recovery among population estimates of the burden of between lower respiratory symptoms
the FDNY participants 6 years after the disease. However, many cases of COPD/ and every measure of severity of dust
disaster. The firefighters with the emphysema in this cohort were also cloud exposure among WTC Health
heaviest dust exposure (those arriving at diagnosed by FDNY physicians [Webber Registry participants. Weiden et al. also
the WTC site on the morning of the et al.] who were trained to diagnose found a dose-response gradient (upward
disaster) had significantly larger respiratory diseases using defined trend) in FDNY responders presenting
declines than did those arriving at later diagnostic criteria after integrating the for pulmonary evaluation due to reports
times. Importantly, the findings of both history, physical examination, of functional impairment or
studies were independent of smoking spirometry, pulmonary function testing abnormalities in screening spirometry or
history. A major limitation of both and chest imaging findings. chest radiographs. However, in this
studies was the lack of spirometry Finally, among WTC Health Registry group of patients, exposure intensity
during the first days after September 11, (Registry) participants, exposure factors had a significant impact only when
2001, preventing the authors from (dust cloud density, smoke at home or spirometry obtained within 1 year post-
determining whether some workers had work, and dust at home or work) and 9/11 was compared to spirometry from
an even more severe immediate decline IOS outcomes (indicative of distal 1 year pre-9/11. This suggests that while
in FEV1 and subsequent incomplete airways obstruction) were statistically initial exposure intensity is the critical
recovery. The possibility of systematic associated with persistent post-9/11 determinant of acute inflammation and
bias occurring due to the change of onset of lower respiratory symptoms early reductions in lung function, the
spirometer equipment between [Friedman et al.]. Both acute and clinical course of non-resolving airway
measurements and a loss-to-follow-up chronic exposures to the events of inflammation and airways obstruction
effect due to drop out of severely September 11, 2001 were independently appears to be dependent not only on the
affected participants from the study over associated with lower respiratory intensity of the initial insult, but also on
time (survivor effect) were additional symptoms among individuals who lived the host’s inflammatory response,
concerns [Aldrich et al.]; however, these and worked in the area of the WTC site reflecting the complexity of genetic-
appeared to have been minimized by [Maslow et al.]. Limitations of these environmental interactions.
further statistical analyses and strong studies include the use of spirometry Finally, the studies were reviewed for
cohort retention rate, respectively. and IOS measurements from a single
plausibility and coherence with known
In addition to the Weiden and Aldrich visit and the possibility of selection bias
facts about the biology of the health
studies, strength of association was also from Registry surveys. However, the
condition. Exposure to the massive
demonstrated by Weakley et al., who demographics were similar among
alkaline dust cloud produced by the
found that annual estimates from 2007– Registry participants and those who
collapse of the WTC buildings was
2009 indicated prevalence ratios of were eligible but chose not to
reportedly associated with upper and
chronic bronchitis and COPD/ participate in the studies.
The studies were next assessed for lower airway irritation with penetration
emphysema that were significantly
consistency of their findings. Objective into the bronchial tree, distal airways,
higher among exposed white male
findings of new onset, post-9/11 and and alveoli leading to respiratory
firefighters than unexposed white males
persistent airflow limitation, as well as symptoms, pulmonary function
(stratified by age and smoking status),
physician-diagnosed cases of COPD, changes, and chronic inflammation.
with greater disparity in the younger age
including chronic bronchitis and COPD/ These are known contributing risk
group (18–44 years). Similarly, Webber
emphysema, were identified among factors for the development of COPD.26
et al. reported significant associations of
9/11 exposures and reduced pulmonary symptomatic FDNY responders for Persistent pulmonary function findings
function with physician-diagnosed whom pre-9/11 results were available of reduced FEV1, FVC and the ratio of
asthma, chronic bronchitis, and COPD/ [Weiden et al.; Aldrich et al.; Webber et FEV1/FVC, bronchial hyperreactivity,
emphysema in a high proportion of al.; Weakley et al.]. Elevated rates of variable response to bronchodilator, and
FDNY rescue workers, indicating that lung function abnormalities, including abnormal oscillometry were indicative
distal airway dysfunction, new and of airway injury. Airway disease was
9/11 exposure and a health condition (including the persistent lower respiratory also identified as bronchial wall
magnitude of the effect and statistical significance); symptomatology, and a few post-9/11 thickening and air trapping by HRCT
rmajette on DSK7SPTVN1PROD with PROPOSALS
(ii) Consistency of the findings across multiple self-reported physician diagnoses of [Weiden et al.]. Air trapping
studies; (iii) Biological gradient, or dose-response (demonstrated by increased residual
relationships between 9/11 exposures and the chronic bronchitis, COPD, and
health condition; and (iv) Plausibility and emphysema were also described among volume) was correlated with
coherence with known facts about the biology of the non-FDNY residents and area workers
health condition. See: Howard J, Administrator of up to 9 years after September 11, 2001
26 Rom WN, Reibman J, Rogers L, Weiden MD,
the WTC Health Program. Policy and procedures for Oppenheimer B, Berger K, Goldring R, Harrison D,
adding non-cancer conditions to the List of WTC- [Friedman et al.; Maslow et al.]. Prezant D [2010]. Emerging exposures and
Related Health Conditions. October 21, 2014. http:// The studies were also reviewed to respiratory health: World Trade Center dust. Proc
www.cdc.gov/wtc/policies.html#46. assess the biological gradient or dose- Am Thorac Soc. 7(2):142–145.
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bronchodilator responsiveness; association between 9/11 exposure(s) literature review included, ‘‘wounds,’’
however, the lack of quantitative and the health condition. In this ‘‘lacerations,’’ ‘‘brain injury(ies),’’
radiographic measurement of air instance, the Administrator finds there ‘‘injury(ies),’’ ‘‘crush(ing),’’ ‘‘burn(s),’’
trapping was a limitation of this study. is substantial evidence that the 9/11 ‘‘ocular,’’ and ‘‘fracture(s).’’ 29
Interestingly, the authors noted that exposures produced chronic airway The literature search yielded over 300
bronchodilator response can be seen in inflammation manifested by persistent citations; the associated study abstracts
COPD patients when air trapping is lower respiratory symptomatology and were reviewed for relevance to 9/11-
present. Epidemiologically, decline in pulmonary function which exposed populations.30 Of the 300
identification of occupationally-related may have progressed to new-onset citations identified, nine were
COPD is based on observing excess COPD in a proportion of exposed determined to be relevant direct
occurrence of COPD among exposed subjects in the period since exposure, observational studies of 9/11-exposed
workers.27 Among 9/11-exposed independently from any cigarette populations. Relevant papers were then
populations, this excess occurrence can smoking among the cohort. This further reviewed for their quality and
be expressed not only by the increased evidence provides substantial support potential to provide a basis for deciding
prevalence ratios of new-onset post-9/11 for a causal relationship between 9/11 whether to propose adding the health
self-reported and physician-diagnosed exposures and new-onset COPD. condition to the List of WTC-Related
chronic bronchitis and emphysema/ Health Conditions. Only papers that
COPD in the FDNY cohort [Webber et V. Acute Traumatic Injury reported on acute traumatic injuries that
al.; Weakley et al.], but also by evidence A. CCE and Data Center Request To occurred in at least one of the three
of persistent and progressive airflow Consider Adding Acute Traumatic September 11, 2001, terrorist attack sites
limitation among all other symptomatic Injury during the period from September 11,
exposed groups [Friedman et al.; 2001 to July 31, 2002 were found to
On May 13, 2014, the Administrator
Maslow et al.]. exhibit potential for a recommendation.
received a letter from the directors of
In summary, obstructive airways Quality was assessed by the absence of
disease is a category that includes both the WTC Health Program CCEs and Data major study limitations and the use of
asthma and the umbrella term COPD, Centers supporting ‘‘coverage of not standardized data collection methods
which itself includes obstructive only heavy lifting or repetitive strain but such as standard forms or checklists.
chronic bronchitis, obstructive significant traumatic injuries like head Based on these criteria, one relevant
bronchiolitis, and emphysema. Upon trauma, burns, fractures, tendon tears study was not found to be of sufficient
assessment of the literature discussed and serious complex sprains’’ within quality to be included in the analysis
above, the Administrator has found the WTC Health Program.28 The because it did not identify the authors’
evidence that exposure to WTC dust is directors suggested that such significant data collection methods. Of the
associated with the development of traumatic injuries should be included remaining eight studies, the methods
new-onset lower respiratory symptoms, under the Program’s existing coverage of used to collect the information and the
prolonged airway inflammation and musculoskeletal disorders. The directors definitions of the types of injuries vary.
persistent airflow limitation, which are offered data collected by the WTC The time frame studied and the
the main indicators of chronic airways Health Program Data Centers and the populations covered sometimes overlap
obstruction. While it is difficult to WTC Health Registry, demonstrating the between the studies, but taken together
demonstrate that the airway obstruction numbers of individuals who might need the studies provide an overview of the
found in WTC survivors and responders chronic care for traumatic injuries. The types of traumatic injuries that were
is due to COPD versus asthma, three Administrator was also aware that some sustained at the sites of the September
studies reported cases of physician- individuals have experienced certain 11, 2001, terrorist attacks. Accordingly,
diagnosed COPD/emphysema, one musculoskeletal injuries or other the ADS found the eight relevant papers
reported on IOS findings of air trapping injuries caused by known hazards exhibited potential to provide a basis for
and increased small airways resistance, present at sites of the September 11, a decision regarding whether to propose
and another study reported on HRCT 2001, terrorist attacks that may not meet the addition of acute traumatic injury to
findings of bronchial wall thickening, the definition provided in the Act for the List. The studies are summarized
air trapping and emphysema, indicating musculoskeletal disorders. Based on below.
that some proportion of OAD cases these concerns, the Administrator Berrios-Torres et al. [2003] 31
found in WTC survivors and responders requested that the ADS conduct a reviewed the data collected by five
could be interpreted as COPD. Further, literature review regarding acute Disaster Medical Assistance Teams
because some cases of asthma are traumatic injuries among 9/11-exposed (DMATs) deployed by the U.S. Public
known to progress to COPD, it is likely individuals. Health Service to the site of the terrorist
that some of the diagnosed cases of B. Literature Review attack in New York City and by four
asthma seen in these and other hospital emergency departments (EDs)
epidemiologic studies of the 9/11- In accordance with the methodology located within a 3-mile radius of the
exposed populations have already discussed above, the ADS initiated a site. The DMATs and EDs were tasked
progressed to COPD. search of published, peer-reviewed with conducting surveillance of injury
In order to propose the addition of a studies of traumatic injuries suffered by and illness among construction workers,
health condition to the List, the responders, recovery workers, and
Administrator must determine with survivors as a result of the terrorist 29 Databases searched include: PubMed, CINAHL,
rmajette on DSK7SPTVN1PROD with PROPOSALS
high confidence that the evidence attacks on September 11, 2001, and the Web of Science, EMBASE, Health & Safety Science
subsequent response and recovery Abstracts, and NIOSHTIC–2.
supports the findings regarding a causal 30 Only direct observational studies of 9/11-
efforts. Search terms used in the exposed populations were considered to be
27 Balmes J, Becklake M, Blanc P, Henneberger P, relevant.
Kreiss K, Mapp C, Milton D, Schwartz D, Toren K, 28 Musculoskeletal Conditions letter from WTC 31 Berrios-Torres SI, Greenko JA, Phillips M,
Viegi G [2003]. American Thoracic Society Health Program CCE and Data Center directors to Miller JR, Treadwell T, Ikeda RM [2003]. World
Statement: Occupational contribution to the burden Dori Reissman and John Halpin, WTC Health Trade Center rescue worker injury and illness
of airway disease. Am J Respir Crit Care Med. Program at 1. This letter is included in the docket surveillance, New York, 2001. Am J Prev Med
167:787–797. for this rulemaking. 25:79–87.
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FDNY and other fire department sought emergency medical treatment, hours between September 11 and
members, New York Police Department including 28 individuals who required December 31, 2001. The screening
(NYPD) and other police department hospitalization. Twenty-four of the program did not include FDNY
members, emergency medical service hospitalized FDNY workers had members. Records from 7,810
technicians (EMS), and the Federal traumatic injuries including fractures, participants were analyzed, with most
Emergency Management Agency’s back trauma, knee meniscus tears, and participants’ activities associated with
Urban Search and Rescue members, all facial burns. Researchers compared work in either the construction industry
of whom were considered rescue and monthly mean incidence rates for crush or law enforcement. Approximately a
recovery workers. Of the 5,222 rescue injuries, lacerations, and fractures for third of the participants reported at least
workers who received medical care from the 9 months preceding the attacks with one injury or illness requiring medical
either the DMATs or EDs between rates during the month after the attacks treatment that was sustained during
September 14, 2001 and October 11, and found a 200 percent increase in the response activities. A total of 4,768
2001, 89 percent visited DMAT facilities incident rate for crush injuries, a 35 injuries/illnesses were reported by these
and 12 percent visited EDs. Injuries percent increase for lacerations, and a participants, with 961 individuals
including, but not limited to, sprain/ 29 percent increase for fractures. reporting traumatic injuries such as
strain, laceration, abrasion, contusion, Incident rates for such traumatic lacerations, punctures, sprain/strains,
fracture, and crush were the leading injuries after the first month following tears, abrasions, contusions, burns,
cause of visits to DMATs and EDs (19 the attack then returned to levels similar fractures, dislocations and 709
percent) and hospital admissions (40 to those observed before the attacks. individuals reporting eye injuries.
percent). Other visits and admissions According to the authors, nearly a year Yurt et al. [2005] 36 reported on the
were caused by burns, concussions, and after the terrorist attacks, a total of 90 number of burn patients (the authors
eye-related conditions, including FDNY rescue workers were on medical did not specify whether the patients
corneal abrasion and eye irritation. leave or light duty assignments because were responders or survivors) that had
Perritt et al. [2005] 32 analyzed DMAT of orthopedic injuries reported during been transported to any of five burn
data collected between September 14, the first 3 months of activity at the New units near the WTC site shortly after the
2001 and November 20, 2001. Patients York City site. attack. A total of 42 patients were
who presented to the DMAT stations The New York City Department of transported from the WTC site and
included rescue and recovery workers, Health (NYCDOH) [2002] 34 issued a treated at one of the five burn units.
as well as some members of the general report summarizing findings of a field Rutland-Brown et al. [2007] 37
public. Of the 9,349 patient visits investigation to assess injuries and use reviewed the medical records of
recorded by the DMATs, more than 25 of healthcare services by survivors of hospitalized responders (the authors do
percent were attributed to traumatic the terrorist attack. The researchers not clarify whether FDNY members are
injuries, not including eye injuries. reviewed emergency department (ED) included in the study) and survivors of
Among the 22 patients with the highest and inpatient medical records at the the terrorist attacks in New York City
triage severity classification, five four hospitals closest to the WTC site with the goal of identifying diagnosed
involved traumatic injuries such as and a fifth hospital that served as a burn and undiagnosed traumatic brain
carbon monoxide poisonings, abrasions, referral center. Of 790 injured survivors injuries (TBIs).38 The authors identified
needlesticks, electrical injuries, and first treated within 48 hours of the terrorist 14 cases of diagnosed and 21 cases of
or second degree burns. Of the 149 attacks, 50 percent received care within undiagnosed TBIs, from records
patients with a moderate level of the first 7 hours and 18 percent were provided by 36 hospitals. The leading
severity, 58 had traumatic injuries. For hospitalized. Among those hospitalized cause of TBI was being hit by falling
the 6,237 patients classified into the survivors, many sustained burns. debris (22 cases), with other cases
lowest severity category, 1,984 had Survivors with fractures, burns, closed caused by being trampled or falling.
traumatic injuries. Of the 116 patients head injuries, and crush injuries were One-third of the TBIs (13 cases)
transferred to a hospital emergency hospitalized for additional treatment. occurred among rescue workers. More
department, 67 were treated for Perritt et al. [2011] 35 reviewed data than 3 years after the event, four out of
traumatic injuries. collected between July 2002 and April six persons with an undiagnosed TBI
Banauch et al. [2002] 33 reported on 2004 from the WTC Worker and who were contacted reported they
all injuries and illnesses during the 24 Volunteer Medical Screening Program currently were experiencing symptoms
hours after the September 11, 2001, (which would later be known as the consistent with a TBI.
terrorist attacks and all traumatic WTC Medical Monitoring and Wang et al. [2005] 39 reported on the
injuries (including those sustained Treatment Program, the precursor to the experience of hospitals in the area
within the first 24 hours) sustained in WTC Health Program) to monitor the around the Pentagon after the terrorist
the first 3 months after the attacks. health of qualified New York City attacks. According to the authors, few
Researchers identified cases from the responders who worked and/or
FDNY Bureau of Health Services volunteered south of Canal Street in 36 Yurt RW, Bessey PQ, Bauer GJ, Dembicki R,
computerized medical data base. During Manhattan, on the barge loading piers in Laznick H, Alden N, Rabbits A [2005]. A regional
Manhattan, or at the Staten Island burn center’s response to a disaster: September 11,
the first 24 hours after the terrorist 2001, and the days beyond. J Burn Care Rehab 26:
attacks, 240 FDNY rescue workers landfill for at least 24 hours during 117–124.
September 11–30, 2001 or for at least 80 37 Rutland-Brown W, Langlois JA, Nicaj L,
rmajette on DSK7SPTVN1PROD with PROPOSALS
32 Perritt KR, Boal WL, Helix Group [2005]. Thomas RG, Wilt SA, Bazarian JJ [2007]. Traumatic
Injuries and illnesses treated at the World Trade 34 New York City Department of Health brain injuries after mass-casualty incidents: Lessons
Center, 14 September–20 November 2001. Prehosp (NYCDOH) [2002]. Rapid assessment of injuries from the 11 September 2001 World Trade Center
Disast Med 20:177–183. among survivors of the terrorist attacks on the attacks. Prehosp Disast Med 22(3):157–164.
33 Banauch G, McLaughlin M, Hirschhorn R, World Trade Center—New York City, September 38 Undiagnosed or undetected TBIs were
Corrigan M, Kelly K, Prezant D [2002]. Injuries and 2001. MMWR January 11, 2002, 51(01):1–5. identified by an adjudication team of TBI experts
illnesses among New York City Fire Department 35 Perritt KR, Herbert R, Levin SM, Moline J that reviewed the abstracted medical record
rescue workers after responding to the World Trade [2011]. Work-related injuries and illnesses reported information for signs and symptoms of TBIs.
Center attacks. MMWR September 11, 2002, by World Trade Center response workers and 39 Wang D, Sava J, Sample G, Jordan M [2005].
51(Special Issue):1–5. volunteers. Prehosp Disast Med 26(6): 401–407. The Pentagon and 9/11. Crit Care Med 33:S42–S47.
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WTC-Related Health Conditions. The necessary, to select regulatory enrollment would be approximately
Administrator proposes to define the approaches that maximize net benefits 4,000 per year (2,800 new responders
term ‘‘acute traumatic injury’’ as a type (including potential economic, and 1,200 new survivors), based on the
of injury characterized by physical environmental, public health and safety trend in enrollees through July 31, 2014.
damage to a person’s body, including, effects, distributive impacts, and CCE or Nationwide Provider Network
but not limited to, eye injuries, severe equity). E.O. 13563 emphasizes the physicians will conduct a medical
burns, head trauma, fractures, tendon importance of quantifying both costs assessment for each patient and make a
tears, complex sprains, and similar and benefits, of reducing costs, of determination, which the Administrator
injuries. The injury must have been harmonizing rules, and of promoting will then use to certify or not certify the
caused by and occurred immediately flexibility. health condition (in this case, new-onset
after exposure to hazards or adverse This notice of proposed rulemaking COPD or an acute traumatic injury) for
conditions characterized by a one-time has been determined not to be a treatment by the WTC Health Program.
exposure to energy resulting from the ‘‘significant regulatory action’’ under However, for the purpose of this
terrorist attacks or their aftermath; this sec. 3(f) of E.O. 12866. This rule analysis, the Administrator has assumed
requirement is intended to distinguish proposes the addition of new-onset that all diagnosed cases of new-onset
these types of injuries from COPD 41 and acute traumatic injury to COPD and acute traumatic injury will be
musculoskeletal disorders, which are the List of WTC-Related Health certified for treatment by the WTC
already on the List of WTC-Related Conditions established in 42 CFR 88.1. Health Program. Finally, because there
Health Conditions. Musculoskeletal This rulemaking is estimated to cost the are no existing data on new-onset COPD
disorders are generally caused by WTC Health Program between rates related to 9/11 exposures at either
repetitive motion; acute traumatic $5,124,477 and $9,350,966 for the years the Pentagon or Shanksville,
injuries are caused by a specific event 2015 and 2016, the remaining years for Pennsylvania sites, and only limited
or incident. Examples of acute traumatic which the WTC Health Program is data on acute traumatic injuries at the
injuries include but are not limited to a currently funded under the Zadroga Pentagon, the Administrator has used
blow from falling debris, a fall from a Act.42 All of the costs to the WTC only data from studies of individuals
height or a trip suffered during Health Program will be transfers due to who were responders or survivors in the
evacuation, rescue, or recovery the implementation of provisions of the New York City area.
activities, and burns or other injuries Patient Protection and Affordable Care
Prevalence of New-Onset COPD
caused by the ignition of combustible Act (ACA) (Pub. L. 111–148) on January
1, 2014. This notice of proposed To estimate the number of potential
materials, chemical reactions, and
rulemaking has not been reviewed by cases of WTC-related new-onset COPD
explosions. Although these types of
the Office of Management and Budget to be certified for treatment by the WTC
injury occur at the time of the blow, fall, Health Program, we first subtracted the
explosion, or other exposure, symptoms (OMB). The rule would not interfere
with State, local, and Tribal number of current members certified for
of the injury may not immediately an obstructive airways disease,
manifest. governments in the exercise of their
governmental functions. including WTC-exacerbated COPD, from
The Administrator proposes to limit
the total number of members.44 We then
the availability of certification of acute Population Estimates reviewed the surveillance literature to
traumatic injuries to those WTC Health
As of July 31, 2014, the WTC Health determine a prevalence rate for new-
Program members who received initial
Program had enrolled 61,086 responders onset COPD among the non-OAD
medical treatment for the injury no later and 7,806 survivors (68,892 total). Of certified members. In studies of FDNY
than September 11, 2003. The that total population, 56,334 responders members with known pre-9/11 health
Administrator has determined that this and 4,754 survivors (61,088 total) were status and high WTC exposure, Aldrich
date offers a reasonable amount of time participants in previous WTC medical et al. reported that 2 percent of FDNY
in which to expect that an injured programs and were ‘grandfathered’ into firefighters had an FEV1% below 70
responder or survivor received the WTC Health Program established by percent of predicted 45 at year 1 after
treatment for an acute traumatic injury. Title XXXIII of the PHS Act.43 From July September 11, 2001 (a proportion that
The proposed end-date of September 11, 1, 2011 to July 31, 2014, 4,752 new doubled 6.5 years later), and Webber et
2003, is the date originally used to responders and 3,052 new survivors
identify traumatic injuries determined (7,804 total) enrolled in the WTC Health 44 Cases of COPD diagnosed prior to September
to be eligible for treatment by the WTC Program. For the purpose of calculating 11, 2001, are presumed to be eligible for coverage
Medical Monitoring and Treatment a baseline estimate of new-onset COPD
as WTC-exacerbated COPD and therefore would not
Program that pre-dated the WTC Health need coverage for new-onset COPD. Members
and acute traumatic injury prevalence, already certified for an obstructive airway disease
Program. In addition, the PHS Act uses the Administrator projected that new are also removed from the analysis because any
this date as the treatment cut-off date to progression to COPD (i.e., airflow limitation not
identify musculoskeletal disorders 41 WTC-exacerbated COPD is a statutorily covered
fully reversible with bronchodilator) from their
current certified WTC-related OAD condition could
eligible for certification in responders. condition pursuant to PHS Act sec. 3312(a)(3)(A)(v); be considered a health condition medically-
The Administrator seeks comment on this NPRM proposes to add new-onset COPD associated with the certified WTC-related OAD
whether September 11, 2003, is an occurring after 9/11 exposures. condition. See: Howard J [2014]. Health conditions
42 Future cost and prevalence estimates described
appropriate deadline. medically associated with World Trade Center-
below are discounted at 3% and 7% in accordance related health conditions. http://www.cdc.gov/wtc/
VIII. Regulatory Assessment with OMB Circular A–94, Guidelines and discount pdfs/WTCHPMedically%20AssociatedHealth
rmajette on DSK7SPTVN1PROD with PROPOSALS
rates for benefit-cost analysis of Federal programs. Conditions7November2014.pdf.
Requirements The estimates are discounted in order to compute 45 FEV1% predicted is a marker for severity of
net present value. airway obstruction. In the setting of post-
A. Executive Order 12866 and Executive 43 These grandfathered members were enrolled
bronchodilator FEV1/FVC ≤0.7, FEV1% predicted
Order 13563 without having to complete a new member ≥80 indicates mild COPD; 50–80, moderate; 30–50,
Executive Orders (E.O.) 12866 and application when the WTC Health Program started severe, and <30, very severe. See: American
on July 1, 2011 and are referred to in the WTC Thoracic Society COPD Guidelines [2004]. http://
13563 direct agencies to assess all costs Health Program regulations in 42 CFR part 88 as www.thoracic.org/clinical/copd-guidelines/for-
and benefits of available regulatory ‘‘currently identified responders’’ and ‘‘currently health-professionals/definition-diagnosis-and-
alternatives and, if regulation is identified survivors.’’ staging/definitions.php.
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![54756 Federal Register / Vol. 80, No. 176 / Friday, September 11, 2015 / Proposed Rules
al. reported an approximate 4 percent studies of WTC survivors, the members and also to the projected
prevalence of new-onset, self-reported, Administrator has determined that the 4 annual enrollment of 4,000 new
physician-diagnosed COPD/emphysema percent prevalence of new-onset COPD members to estimate the number of
nearly ten years after rescue/recovery will be applied to survivor estimates as potential WTC-related new-onset COPD
efforts at the WTC site. Because pre-9/ well.46 We applied the 4 percent cases for 2015 and 2016. (See Table 1,
11 health records were not available in prevalence to the number of remaining below)
TABLE 1—ESTIMATED PREVALENCE OF 2015 AND 2016 NEW-ONSET COPD CASES
2015 2016 Total cases
Undiscounted
Responders .................................................................................................................................. 2,013 2,125 4,138
Survivors ...................................................................................................................................... 291 339 630
Total ...................................................................................................................................... 2,304 2,464 4,768
Discounted at 3%
Responders .................................................................................................................................. 1,954 2,003 3,957
Survivors ...................................................................................................................................... 283 320 603
Total ...................................................................................................................................... 2,237 2,323 4,560
Discounted at 7%
Responders .................................................................................................................................. 1,881 1,856 3,737
Survivors ...................................................................................................................................... 272 296 568
Total ...................................................................................................................................... 2,153 2,152 4,305
Prevalence of Acute Traumatic Injury number of responders and survivors the number of individuals who may
While this rulemaking would make who received medical treatment for have suffered a WTC-related acute
acute traumatic injuries eligible for acute traumatic injuries on or in the traumatic injury. Next, in order to
certification, the Administrator assumes aftermath of September 11, 2001, we do estimate the proportion of those in the
that the conditions most likely to not know the number of individuals responder and survivor populations
receive treatment within the WTC who still experience health problems who suffered WTC-related acute
Health Program will be those medically because of those traumatic injuries and traumatic injuries that require chronic
associated conditions which are the are in need of chronic care. First, we care, we assumed that all patients with
long-term consequences of the certified estimated the number of persons in the permanent partial and permanent total
WTC-related acute traumatic injuries. responder and survivor populations impairment caused by acute traumatic
Health conditions medically associated with 9/11-related acute traumatic injuries will require chronic medical
with WTC-related health conditions are injuries by reviewing the studies care and will enroll in the WTC Health
determined on a case-by-case basis in referenced above in the acute traumatic Program. The National Safety Council
accordance with WTC Health Program injury literature review; we derived estimated that 3.8 percent of non-fatal
policy.47 Examples of such health estimates from Berrios-Torres et al. disabling injuries 50 are associated with
conditions medically associated with an [2003], Banauch et al. [2002], Perritt et permanent partial or permanent total
acute traumatic injury may include al. [2011], and NYCDOH [2002]. Using impairment.51 We applied that estimate
chronic back pain caused by vertebrae the estimated prevalence for injury to the estimated number of current and
fractures, chronic peripheral neuropathy types, we then calculated the prevalence expected WTC Health Program members
due to severe burns, and problems with for these injuries among the who may have suffered a WTC-related
executive brain function due to closed responder 48 and survivor 49 acute traumatic injury to determine the
head injuries. populations. We applied that prevalence number of individuals with WTC-
Although we were able to estimate to the number of current and expected related acute traumatic injuries who are
from the surveillance literature the WTC Health Program members to find in need of chronic care. (See Table 2,
46 The 4 percent prevalence of new-onset COPD and we assume no additional injuries from within the first 48 hours after the terrorist attacks,
that was observed among firefighters was used to December 11, 2001 until the site was closed in July the reported number of cases likely underestimates
estimate the number of expected cases of new-onset 2002. The time period reported on by Banauch et the total number of survivors who sustained acute
COPD in the entire exposed cohort and may result al. likely encompasses a large majority of the traumatic injuries as a result of the September 11,
in an overestimation because of the differences in injuries suffered by FDNY members. Second, Perritt 2001, terrorist attacks.
initial exposure intensity between responders and et al. does not report directly on closed head 50 In 2011, the National Safety Council replaced
rmajette on DSK7SPTVN1PROD with PROPOSALS
survivors. injuries; therefore the number of closed head
the term ‘‘disabling injury’’ with ‘‘medically
47 Howard J [2014]. Health conditions medically
injuries reported by Berrios-Torres et al. for
responders is used. consulted injury.’’ See National Safety Council
associated with World Trade Center-related health 49 We estimate the survivor prevalence from the [2014]. Injury facts.
conditions. http://www.cdc.gov/wtc/pdfs/WTCHP NYCDOH study reports on survivors during the
51 A non-fatal disabling injury is one which
Medically%20AssociatedHealthConditions7 period from September 11–13, 2001. Although we results in some degree of permanent impairment or
November2014.pdf. understand that this reporting period likely renders the injured person unable to effectively
48 The responder estimate is subject to two main perform his regular duties or activities for a full day
encompasses a majority of the survivors who were
assumptions. First, Banauch et al. report on FDNY injured, because the number of cases is based on beyond the day of the injury. National Safety
members from September 11 to December 10, 2001, those survivors who were treated for injuries only Council [1986]. Injury facts.
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![Federal Register / Vol. 80, No. 176 / Friday, September 11, 2015 / Proposed Rules 54757
below.) The Administrator welcomes used to determine the number of current members who may seek certification of
input on the assumptions and estimates and future WTC Health Program WTC-related acute traumatic injuries.
TABLE 2—ESTIMATED PREVALENCE OF 2015 AND 2016 ACUTE TRAUMATIC INJURY CASES
2015 2016 Total cases
Undiscounted
Responders .................................................................................................................................. 76 79 155
Survivors ...................................................................................................................................... 9 10 19
Total ...................................................................................................................................... 85 89 174
Discounted at 3%
Responders .................................................................................................................................. 74 74 148
Survivors ...................................................................................................................................... 9 9 18
Total ...................................................................................................................................... 83 83 166
Discounted at 7%
Responders .................................................................................................................................. 71 69 140
Survivors ...................................................................................................................................... 8 9 17
Total ...................................................................................................................................... 79 78 157
Costs of COPD Treatment percent would result in $973 and at 7 supplies, including oxygen, and also
The Administrator estimated the percent in $901 per member. included the cost of pharmaceuticals.
medical treatment costs associated with The high estimate, $1,930 per case, The medical cost per case was about
COPD in this rulemaking, using the was based on a study by Leigh et al. $1,012 in 1996 dollars or about $1,930
methods described below, to be between [2002].53 The authors estimated the cost in 2014, after adjusting for inflation
$1,032 and $1,930 per case in 2014. of occupational COPD by aggregating using the Medical Consumer Price Index
The low estimate, $1,032 per case, and analyzing national data sets for all urban consumers. Discounting
was based on WTC Health Program collected by the National Center for future medical costs for the following
costs associated with the treatment of Health Statistics, the Health Care year (2015) at 3 percent would result in
WTC-exacerbated COPD for the period Financing Administration, and other $1,874 and at 7 percent in $1,804 per
October 1, 2013 through September 30, government agencies and private firms. COPD case. Discounting future medical
2014. These medical costs included They concluded that there were an costs for one more year (2016) at 3
medical services only.52 Discounting estimated 2,395,650 occupational cases percent would result in $1,819 and at 7
future medical costs for the following of COPD in 1996 that resulted in percent in $1,686 per COPD case.54
year (2015) at 3 percent would result in medical costs estimated at $2.425 Table 3 below shows the net present
$1,002 and at 7 percent in $965 per billion. Medical costs included value of the range of the medical
member. Discounting future medical payments to hospitals, physicians, treatment cost per COPD case for the
costs for one more year (2016) at 3 nursing homes, and vendors of medical period 2015–2016:
TABLE 3—PRESENT VALUE OF 2015 AND 2016 MEDICAL TREATMENT COST PER COPD CASE IN 2014 DOLLARS
Discounted Discounted
Source Year Undiscounted at 3% at 7%
WTC Health Program .............................................................. 2015 $1,032 $1,002 $965
2016 1,032 973 901
Total .................................................................................. .............................. 2,064 1,975 1,866
Leigh et al. (2002) ................................................................... 2015 1,930 1,874 1,804
2016 1,930 1,819 1,686
Total .................................................................................. .............................. 3,860 3,693 3,490
rmajette on DSK7SPTVN1PROD with PROPOSALS
52 Costs may be underestimated because 53 Leigh JP, Romano PS, Schenker MB, Kreiss K for Chronic Obstructive Pulmonary Disease Using
pharmaceuticals are not included in the analysis. [2002]. Costs of occupational COPD and asthma. Spirometry. http://
Although the WTC Health Program does treat Chest. Jan;121(1):264–272. www.uspreventiveservicestaskforce.org/uspstf/
patients with WTC-exacerbated COPD, the cost of 54 The U.S. Preventive Services Task Force does uspscopd.htm. Accessed September 10, 2014.
pharmaceuticals for this health condition is not
readily available. not recommended screening for COPD. Screening
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![54758 Federal Register / Vol. 80, No. 176 / Friday, September 11, 2015 / Proposed Rules
Costs of Acute Traumatic Injury of providing medical treatment for acute • Claimants with dates of birth
Treatment traumatic injury to be around $11,216 between 1920 and 1970
per case in 2014. • States for which NCCI collects
The Administrator estimated the This cost figure was based on a study MDC 56
medical treatment costs associated with by the National Council on For individuals born during 1951–
acute traumatic injury in this Compensation Insurance (NCCI).55 The 1970, the medical cost per case was
rulemaking using the methods described data source used in this study was about $11,216 in 2014 dollars, after
below. Because it is not possible to NCCI’s Medical Data Call (MDC). The adjusting for inflation using the Medical
identify all possible types of acute MDC captures transaction-level detail Consumer Price Index for all urban
traumatic injury for which a WTC on workers’ compensation medical bills consumers.57 Discounting future
responder or survivor might seek processed on or after July 1, 2010, medical costs for the following year
certification, we have identified several including dates of service, charges, (2015) at 3 percent would result in
types of acute traumatic injury that may payments, procedure codes, and $10,890 and at 7 percent in $10,482 per
represent those types of acute traumatic diagnosis codes; pharmaceutical costs acute traumatic injury case. Discounting
injury that might be certified by the are also included. The data used in this future medical costs for one more year
WTC Health Program. Representative study were evaluated as of March 2013 (2016) at 3 percent would result in
examples of acute traumatic injuries for: $10,572 and at 7 percent in $9,796 per
include closed head injuries, burns, • Long-term medical services traumatic injury case.
fractures, strains and sprains, provided in 2011 and 2012 (i.e., 20 to Table 4 below shows the present
orthopedic injuries (e.g., meniscus tear), 30 years post injury) value of the range of the medical
ocular injuries, and crush injuries. The • Injuries occurring between 1983 treatment cost per traumatic injury case
WTC Health Program estimates the cost and 1990 for the period 2015–2016:
TABLE 4—PRESENT VALUE OF 2015 AND 2016 MEDICAL TREATMENT COST PER ACUTE TRAUMATIC INJURY CASE IN 2014
DOLLARS
Discounted Discounted
Source Year Undiscounted at 3% at 7%
NCCI (2014) ............................................................................. 2015 $11,216 $10,890 $10,482
2016 11,216 10,572 9,796
Total .................................................................................. .............................. 22,432 21,462 20,278
Summary of Costs monitoring services. In the calculations are WTC-related health conditions that
found in Tables 5 and 6, below, might result from this action. Those
This rulemaking is estimated to cost estimated treatment costs were applied costs were addressed in the interim final
the WTC Health Program between to the estimated number of cases of rule that established regulations for the
$5,124,477 and $9,350,966 for the years new-onset COPD and acute traumatic WTC Health Program (76 FR 38914, July
2015 and 2016.58 The analysis above injuries. We assumed that 9 percent of 1, 2011).
offers an assumption about the number new-onset COPD costs and 12 percent of
of individuals who might enroll in the acute traumatic injury costs for Since the implementation of
WTC Health Program and estimates the responders may be covered by workers’ provisions of the Affordable Care Act on
number of new-onset COPD and acute compensation each year; 59 accordingly, January 1, 2014, all of the members and
traumatic injury cases and the resulting we adjusted only the responder future members are assumed to have or
estimated treatment costs to the WTC estimates to clarify that 91 percent of have access to medical insurance
Health Program. For the purpose of COPD costs and 88 percent of acute coverage other than through the WTC
computing the treatment costs for new- traumatic injury costs will be paid by Health Program. Therefore, all treatment
onset COPD and acute traumatic injury, the WTC Health Program.60 This costs to be paid by the WTC Health
the Administrator assumed that all of analysis does not include administrative Program through 2016 are considered
the individuals who are diagnosed with costs associated with certifying transfers. Tables 5 and 6 describe the
either condition will be certified by the additional diagnoses of new-onset estimated allocation of WTC Health
WTC Health Program for treatment and COPD or acute traumatic injuries that Program transfer payments.
55 Colón D [2014]. The impact of claimant age on 57 Bureau of Labor Statistics. Consumer Price discounted at 3 percent, from Table 5 and the acute
rmajette on DSK7SPTVN1PROD with PROPOSALS
late-term medical costs. NCCI Research brief, Index. https://research.stlouisfed.org/fred2/series/ traumatic injury treatment cost estimate, discounted
October 2014. https://www.ncci.com/documents/ CPIMEDSL/downloaddata?cid=32419. Accessed at 3 percent, from Table 6.
Impact-Claimant-Age-Late-Term-Med-Costs.pdf. November 5, 2014. 59 See: WTC Health Program. Policy and
58 The low cost estimate reflects the low COPD
Accessed February 4, 2015. procedures for recoupment and coordination of
treatment cost estimate using WTC Health Program
56 AK, AL, AR, AZ, CO, CT, DC, FL, GA, HI, IA, benefits: workers’ compensation payment. http://
data, discounted at 7 percent, from Table 5 and the
ID, IL, IN, KS, KY, LA, MA, MD, ME, MN, MO, MS, acute traumatic injury treatment cost estimate, www.cdc.gov/wtc/pdfs/WTCHP-PP-Recoupment-
MT, NC, NE, NH, NJ, NM, NV, NY, OK, OR, RI, SC, discounted at 7 percent, from Table 6. The high cost WComp-16-Dec-13.pdf.
60 Workers’ compensation rates are derived from
SD, TN, UT, VA, VT, WI, and WV estimate reflects the high COPD treatment cost
estimate using data from Leigh et al. (2002), WTC Health Program data.
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![54760 Federal Register / Vol. 80, No. 176 / Friday, September 11, 2015 / Proposed Rules
agency to consider the potential impact federalism, and has determined that it § 88.1 Definitions.
of its regulations on small entities does not have ‘‘federalism * * * * *
including small businesses, small implications.’’ The rule does not ‘‘have List of WTC-related health conditions
governmental units, and small not-for- substantial direct effects on the States, * * *
profit organizations. The Administrator on the relationship between the national (1) * * *
believes that this rule has ‘‘no government and the States, or on the (v) WTC-exacerbated and new-onset
significant economic impact upon a distribution of power and chronic obstructive pulmonary disease
substantial number of small entities’’ responsibilities among the various (COPD).
within the meaning of the Regulatory levels of government.’’
* * * * *
Flexibility Act (5 U.S.C. 601 et seq.).
H. Executive Order 13045 (Protection of (5) Acute traumatic injuries for those
C. Paperwork Reduction Act Children from Environmental Health WTC responders and screening- and
The Paperwork Reduction Act (PRA), Risks and Safety Risks) certified-eligible WTC survivors who
44 U.S.C. 3501 et seq., requires an received any medical treatment for such
In accordance with Executive Order an injury on or before September 11,
agency to invite public comment on, 13045, the Administrator has evaluated
and to obtain OMB approval of, any 2003. Acute traumatic injury means
the environmental health and safety physical damage to the body caused by
regulation that requires 10 or more effects of this proposed rule on children.
people to report information to the and occurring immediately after a one-
The Administrator has determined that time exposure to energy, such as heat,
agency or to keep certain records. This the rule would have no environmental
rule does not contain any information electricity, or impact from a crash or
health and safety effect on children. fall, resulting from a specific event or
collection requirements; thus, HHS has
determined that the PRA does not apply I. Executive Order 13211 (Actions incident. Eligible acute traumatic
to this rule. Concerning Regulations that injuries may include but are not limited
Significantly Affect Energy Supply, to the following:
D. Small Business Regulatory Distribution, or Use) (i) Eye injuries.
Enforcement Fairness Act (ii) Severe burns.
As required by Congress under the In accordance with Executive Order (iii) Head trauma.
Small Business Regulatory Enforcement 13211, the Administrator has evaluated (iv) Fractures.
Fairness Act of 1996 (5 U.S.C. 801 et the effects of this proposed rule on (v) Tendon tears.
seq.), HHS will report the promulgation energy supply, distribution or use, and (vi) Complex sprains.
of this rule to Congress prior to its has determined that the rule will not (vii) Other similar acute traumatic
effective date. have a significant adverse effect. injuries.
J. Plain Writing Act of 2010 * * * * *
E. Unfunded Mandates Reform Act of
1995 Under Public Law 111–274 (October Dated: August 31, 2015.
13, 2010), executive Departments and John Howard,
Title II of the Unfunded Mandates
Reform Act of 1995 (2 U.S.C. 1531 et Agencies are required to use plain Administrator, World Trade Center Health
language in documents that explain to Program and Director, National Institute for
seq.) directs agencies to assess the
the public how to comply with a Occupational Safety and Health, Centers for
effects of Federal regulatory actions on Disease Control and Prevention, Department
State, local, and Tribal governments, requirement the Federal Government of Health and Human Services.
and the private sector ‘‘other than to the administers or enforces. The
[FR Doc. 2015–22599 Filed 9–9–15; 11:15 am]
extent that such regulations incorporate Administrator has attempted to use
BILLING CODE P
requirements specifically set forth in plain language in promulgating the
law.’’ For purposes of the Unfunded proposed rule consistent with the
Mandates Reform Act, this proposed Federal Plain Writing Act guidelines.
rule does not include any Federal DEPARTMENT OF THE INTERIOR
Proposed Rule
mandate that may result in increased Bureau of Land Management
annual expenditures in excess of $100 List of Subjects in 42 CFR Part 88
million in 1995 dollars by State, local or Administrative practice and 43 CFR Parts 3160 and 3170
Tribal governments in the aggregate, or procedure, Health care, Lung diseases,
by the private sector. However, the rule [15X.LLWO300000.L13100000.NB0000]
Mental health programs.
may result in an increase in the RIN 1004–AE15
contribution made by New York City for For the reasons discussed in the
treatment and monitoring, as required preamble, the Department of Health and Onshore Oil and Gas Operations;
by Title XXXIII, sec. 3331(d)(2). Human Services proposes to revise 42 Federal and Indian Oil and Gas Leases;
CFR part 88 as follows: Site Security
F. Executive Order 12988 (Civil Justice)
This proposed rule has been drafted PART 88—WORLD TRADE CENTER AGENCY: Bureau of Land Management,
and reviewed in accordance with HEALTH PROGRAM Interior.
Executive Order 12988, ‘‘Civil Justice ACTION: Proposed rule; extension of
Reform,’’ and will not unduly burden ■ 1. The authority citation for part 88 public comment period.
rmajette on DSK7SPTVN1PROD with PROPOSALS
the Federal court system. This rule has continues to read as follows:
been reviewed carefully to eliminate SUMMARY: On July 13, 2015, the Bureau
Authority: 42 U.S.C. 300mm–300mm–61,
drafting errors and ambiguities. Pub. L. 111–347, 124 Stat. 3623. of Land Management (BLM) published
in the Federal Register a proposed rule
G. Executive Order 13132 (Federalism) ■ 2. In § 88.1, under the definition ‘‘List to establish minimum standards for site
The Administrator has reviewed this of WTC-related health conditions,’’ security at oil and gas facilities located
proposed rule in accordance with revise paragraph (1)(v) and add on Federal and Indian (except Osage
Executive Order 13132 regarding paragraph (5) to read as follows: Tribe) lands. This proposed rule would
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Document Created: 2015-12-15 10:00:12
Document Modified: 2015-12-15 10:00:12
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Proposed Rules | |
| Action | Notice of proposed rulemaking. | |
| Dates | Comments must be received by October 26, 2015. | |
| Contact | Rachel Weiss, Program Analyst, 1090 Tusculum Ave, MS: C-46, Cincinnati, OH 45226; telephone (855)818-1629 (this is a toll-free number); email [email protected] | |
| FR Citation | 80 FR 54746 | |
| RIN Number | 0920-AA61 | |
| CFR Associated | Administrative Practice and Procedure; Health Care; Lung Diseases and Mental Health Programs |
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