[Federal Register Volume 78, Number 127 (Tuesday, July 2, 2013)]
[Proposed Rules]
[Pages 39670-39691]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-15816]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Docket No. CDC-2013-0012]

42 CFR Part 88

RIN 0920-AA54


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

AGENCY: Centers for Disease Control and Prevention, HHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: On May 2, 2013, the Administrator of the World Trade Center 
(WTC) Health Program received a petition (Petition 002) requesting the 
addition of prostate cancer to the List of WTC-Related Health 
Conditions (List) covered in the WTC Health Program. The Administrator 
has determined to publish a proposed rule adding malignant neoplasm of 
the prostate (prostate cancer) to the List in the WTC Health Program 
regulations.

DATES: Comments must be received by August 1, 2013.

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, Robert A. Taft Laboratories, 
MS-C34, 4676 Columbia Parkway, Cincinnati, OH 45226.
    Instructions: All submissions received must include the agency name 
(Centers for Disease Control and Prevention, HHS) and docket number 
(CDC-2013-0012) or Regulation Identifier Number (0920-AA54) 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.

[[Page 39671]]

    Docket: For access to the docket to read background documents, go 
to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Paul Middendorf, Senior Health 
Scientist, 1600 Clifton Rd. NE., MS: E-20, Atlanta, GA 30329; telephone 
(404) 498-2500 (this is not a toll-free number); email 
pmiddendorf@cdc.gov.

SUPPLEMENTARY INFORMATION: 
    This notice is organized as follows:

I. Executive Summary
    A. Purpose of Regulatory Action
    B. Summary of Major Provisions
    C. Costs and Benefits
II. Public Participation
III. Background
    A. WTC Health Program Statutory Authority
    B. Rulemaking History
    C. Methods Used by the Administrator To Determine Whether To Add 
Cancer or Types of Cancer to the List of WTC-Related Health 
Conditions
    D. Consideration of Prostate Cancer, 2011-2012
    1. First Periodic Review of the Scientific and Medical Evidence 
Related to Cancer, July 2011
    2. Rulemaking in Response to Petition 001
    E. Petition 002
IV. Administrator's Determination on Petition 002 Requesting the 
Addition of Prostate Cancer to the List
V. Early Detection of Prostate Cancer
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 response to a petition to the 
Administrator of the WTC Health Program by the Patrolmen's Benevolent 
Association, a union representing New York City police officers 
(Petition 002). The petition asks that the Administrator add prostate 
cancer to the List of WTC-Related Health Conditions.

B. Summary of Major Provisions

    The rule proposes the addition of prostate cancer to the cancers 
identified in 42 CFR 88.1, Table 1 as covered by the WTC Health Program 
for treatment and monitoring.

C. Costs and Benefits

    The proposed addition of prostate cancer by this rulemaking is 
estimated to cost the WTC Health Program between $3,462,675 and 
$6,995,817 per annum. All of the costs to the WTC Health Program will 
be transfers after the implementation of provisions of the Patient 
Protection and Affordable Care Act (Pub. L. 111-148) on January 1, 
2014.

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.
    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-2013-0012'' 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.

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 \1\ 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 (responders) who responded to the 
September 11, 2001, terrorist attacks in New York City, at the 
Pentagon, and in Shanksville, Pennsylvania, and to eligible persons 
(survivors) 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.
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    \1\ 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.
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    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. Rulemaking History

    On September 7, 2011, the Administrator received a written petition 
to add a health condition to the List in Sec.  88.1 (Petition 001). 
Petition 001 requested that the Administrator ``conduct an immediate 
review of new medical evidence showing increased cancer rates among 
firefighters who served at ground zero and that [the Administrator] 
consider adding coverage for cancer under the Zadroga Act.'' \2\
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    \2\ Letter dated September 7, 2011 from U.S. Senators Charles E. 
Schumer and Kirsten E. Gillibrand, and U.S. Representatives Carolyn 
B. Maloney, Jerrold Nadler, Peter T. King, Charles B. Rangel, Nydia 
M. Vel[aacute]zquez, Michael C. Grimm and Yvette D. Clarke to John 
Howard, M.D.
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    Pursuant to section 3312(a)(6)(B) of the PHS Act, interested 
parties may petition to add a health condition to the List. Within 60 
calendar days after receipt of a petition to add a condition to the 
List, the Administrator must take one of the following four actions 
described in 42 CFR 88.17: (i) Request a recommendation of the WTC 
Health Program Scientific/Technical Advisory Committee (STAC); (ii) 
publish a proposed rule in the Federal Register to add such health 
condition; (iii) publish in the Federal Register the Administrator's 
determination not to publish such a proposed rule and the basis for 
such determination; or (iv) publish in the Federal Register a 
determination that insufficient evidence exists to take action under 
(i) through (iii) above.
    On October 5, 2011, the Administrator formally exercised his option 
to request a recommendation from the STAC regarding Petition 001.\3\ In 
a letter to the STAC the Administrator requested ``that the STAC review 
the available information on cancer outcomes associated with the 
exposures resulting

[[Page 39672]]

from the September 11, 2001, terrorist attacks, and provide advice on 
whether to add cancer, or a certain type of cancer, to the List 
specified in the Zadroga Act.'' \4\
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    \3\ See PHS Act, sec. 3312(a)(6)(B)(i); 42 CFR 88.17(a)(2)(i).
    \4\ Letter dated October 5, 2011 from John Howard, M.D. to 
Elizabeth Ward, Ph.D., STAC Chair available at http://www.cdc.gov/niosh/docket/archive/pdfs/NIOSH-248/0248-100511-letter.pdf. Accessed 
June 1, 2013.
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    In response to the Administrator's request, the STAC submitted its 
recommendation on April 2, 2012. After considering the STAC's 
recommendation, the Administrator issued a notice of proposed 
rulemaking on June 13, 2012 (77 FR 35574). On September 12, 2012, the 
Administrator published a final rule in the Federal Register adding 
over 50 types of cancer to the List of WTC-Related Health Conditions in 
42 CFR 88.1 (77 FR 56138).\5\
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    \5\ On October 12, 2012, HHS published a Federal Register notice 
to correct errors in Table 1 of the final rule (the list of cancers 
covered by the Program) (77 FR 62167).
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C. Methods Used by the Administrator To Determine Whether To Add Cancer 
or Types of Cancer to the List of WTC-Related Health Conditions

    In the final rule published September 12, 2012, the Administrator 
established a four-part hierarchical methodology to apply in evaluating 
whether to propose adding certain types of cancer to the List of WTC-
Related Health Conditions included in 42 CFR 88.1.\6\ Method 1 is the 
preferred method for adding types of cancer to the List. When the 
analysis of epidemiologic studies in Method 1 does not support a causal 
association between 9/11 exposures and a type of cancer, the 
Administrator applies the criteria of Method 2.\7\ If no causal 
association between a currently listed condition and the type of cancer 
is identified using Method 2, the Administrator applies the criteria of 
Method 3. If Method 3 does not indicate that a recognized 9/11 exposure 
is categorized by the National Toxicology Program (NTP) as a known or 
reasonably anticipated human carcinogen \8\ or the International Agency 
for Research on Cancer (IARC) has not determined there is sufficient or 
limited evidence in humans that a 9/11 exposure is causally associated 
with a type of cancer,\9\ then the criteria of Method 4 are applied. 
Under Method 4, the Administrator determines whether the STAC has 
provided a reasonable basis for adding the type of cancer, aside from 
Methods 1, 2, or 3. Only where the Administrator is satisfied that one 
of the four methods provides a reasonable basis to add the cancer will 
he propose that a type of cancer be added to the List. The four methods 
are presented in detail below:
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    \6\ 77 FR 56138, 56142.
    \7\ The results of epidemiologic studies are the primary and 
best evidence for making a determination of a causal association 
between an exposure and a health outcome, such as cancer. An 
analysis of the results of any epidemiologic study has three 
possible outcomes: (1) The analysis supports an association between 
exposures and a health outcome (yes); (2) the analysis supports that 
there is no association between exposures and a health outcome (no); 
or (3) the analysis is inconclusive about whether an association 
exists between exposures and a health outcome (inconclusive).
    \8\ National Toxicology Program (NTP), U.S. Department of Health 
and Human Services. Report on Carcinogens (RoC). http://ntp.niehs.nih.gov/?objectid=72016262-BDB7-CEBA-FA60E922B18C2540. 
Accessed May 15, 2013.
    \9\ World Health Organization International Agency for Research 
on Cancer (IARC). http://monographs.iarc.fr/. Accessed May 15, 2013.

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

D. Consideration of Prostate Cancer, 2011-2012

    Since 2011, the Administrator has twice evaluated whether to add 
health conditions to the List. In both instances, the Administrator 
considered adding certain types of cancer to the List, including 
prostate cancer.
1. First Periodic Review of the Scientific and Medical Evidence Related 
to Cancer, July 2011
    The Administrator's first evaluation was published in the July 2011 
First Periodic Review of the Scientific and Medical Evidence Related to 
Cancer (First Periodic Review) for the WTC Health Program. As required 
by Title XXXIII, section 3312(a)(5)(A) of the PHS Act, the 
Administrator reviewed ``all available scientific and medical evidence, 
including findings and recommendations of Clinical Centers of 
Excellence, published in peer-reviewed journals to determine if, based 
on such evidence, cancer or a certain type of cancer should be added to 
the applicable list of WTC-related health conditions.'' The 
Administrator used a ``weight of the evidence'' approach to evaluate 
the available data. At that time, there were no significant 
epidemiologic studies available which evaluated the association of 9/11 
exposures and health outcomes involving types of cancer. As a result, 
the Administrator determined that insufficient evidence existed at that 
time to propose the addition of cancer, or certain types of cancer, to 
the List, but cautioned that,

the current absence of published scientific and medical findings 
demonstrating a causal association between exposures resulting from 
the September 11, 2001, terrorist attacks and the occurrence of 
cancer in responders and survivors does not indicate evidence of the 
absence of a causal association.\10\

    \10\ First Periodic Review of Scientific and Medical Evidence 
Related to Cancer for the World Trade Center Health Program, VI.C, 
p. 40.
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2. Rulemaking in Response to Petition 001
    The Administrator's second evaluation of whether to add cancer or 
certain types of cancer to the List followed receipt of Petition 001 
and the subsequent recommendation on the

[[Page 39673]]

Petition from the STAC. During meetings held November 9-10, 2011, 
February 15-16, 2012, and March 28, 2012, the STAC reviewed the 
available scientific evidence for adding cancer or certain types of 
cancer to the List and made its recommendation to the Administrator 
regarding Petition 001 on April 2, 2012.
    In reviewing Petition 001, the STAC compiled and reviewed the 
available evidence for adding all types of cancer, including prostate 
cancer, to the List. Specifically, with regard to the analysis of 
prostate cancer, this evidence included (1) the results of a study by 
Zeig-Owens et al., published in The Lancet in September 2011; \11\ and 
(2) a determination by NTP that arsenic and cadmium, 9/11 exposures, 
are known to be human carcinogens \12\ and a determination by IARC that 
limited evidence supports a causal association between prostate cancer 
and arsenic or cadmium exposure.\13\
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    \11\ Zeig-Owens R, Webber MP, Hall CB, Schwartz T, Jaber N, 
Weakley J, Rohan TE, Cohen HW, Derman O, Aldrich TK, Kelly K, 
Prezant DJ [2011]. Early Assessment of Cancer Outcomes in New York 
City Firefighters After the 9/11 Attacks: An Observational Cohort 
Study. Lancet. 378(9794):898-905.
    \12\ NTP (National Toxicology Program) [2011]. 12th Report on 
Carcinogens. National Toxicology Program, Public Health Service, 
U.S. Department of Health and Human Services, Research Triangle 
Park, NC. http://ntp.niehs.nih.gov/?objectid=03C9AF75-E1BF-FF40-DBA9EC0928DF8B15. Accessed May 24, 2013.
    \13\ IARC (International Agency for Research on Cancer) [2012]. 
IARC Monographs on the Evaluation of the Carcinogenic Risks to 
Humans: Vol. 100C--Arsenic, Metals, Fibres, and Dusts. IARC, Lyon, 
France. http://monographs.iarc.fr/ENG/Monographs/vol100C/index.php. 
Accessed May 24, 2013.
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    At the March 28, 2012 meeting, STAC members noted that prostate 
cancer would qualify for inclusion in its recommendation of types of 
cancer that should be added to the List based on evidence from NTP and 
IARC.\14\ However, other STAC members expressed concern that the 
increased rate of prostate cancer in both exposed and unexposed 
firefighters in the Zeig-Owens study was a result of surveillance bias 
associated with widespread screening for prostate cancer. The Zeig-
Owens study involved a small population that was subject to substantial 
medical screening. STAC members expressed concern that the observed 
excess risk for prostate cancer seen in the Zeig-Owens study was the 
result of screening for prostate cancer by means of the prostate-
specific antigen (PSA) test.\15\
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    \14\ STAC (WTC Health Program Scientific/Technical Advisory 
Committee) [2012]. Transcript of the STAC meeting, March 28, 
2012:97-105. http://www.cdc.gov/niosh/docket/archive/pdfs/NIOSH-248/0248-032812-transcript3.pdf. Accessed June 1, 2013.
    \15\ The PSA test was approved by the Food and Drug 
Administration in 1986 for the purpose of monitoring disease status 
in prostate cancer, and in 1994 for the detection of prostate cancer 
in men 50 years and older. The routine use of the PSA test for 
screening increased dramatically beginning in 1998, along with the 
prostate cancer incidence, but the incidence has since fallen. See 
Etzioni R, Penson DF, Legler JM, di Tommaso D, Boer R, Gann PH, 
Feuer EJ. (2002) Overdiagnosis due to prostate-specific antigen 
screening: lessons from U.S. prostate cancer incidence. JNCI 
94(13):981-990; Potosky AL, Miller BA, Albertsen PC, Kramer BS. 
(1995) The role of increasing detection in the rising incidence of 
prostate cancer. JAMA 273:548-552; and Altekruse SF, Kosary C, 
Krapcho M et al. (2010) SEER cancer statistics review 1975-2007. 
Bethesda, MD: National Cancer Institute. http://seer.cancer.gov/csr/1975_2007/. Accessed June 2, 2013.
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    During the meeting, the STAC considered a motion to ``recommend 
adding prostate cancer to the list of covered conditions.'' \16\ The 
motion failed in an 8 to 7 vote. In the April 2, 2012 recommendation, 
the STAC noted that ``the WTC-exposed FDNY [Fire Department of New 
York] group did not show an increased risk over the unexposed, with 
estimated SIR [standardized incidence ratio] ratio [of] 0.90 (after 
correction for possible surveillance bias),'' and concluded 
``therefore, despite the statistically significant SIR for prostate 
cancer in WTC-exposed firefighters compared to the general population, 
the overall results do not support an increased risk of prostate cancer 
associated with WTC exposures.'' \17\ The STAC's discussion and 
subsequent vote indicated that the members found that the epidemiologic 
evidence of 9/11-exposed populations outweighed the NTP and IARC 
evidence of carcinogenicity of arsenic and cadmium.
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    \16\ See STAC (WTC Health Program Scientific/Technical Advisory 
Committee) [2012]. Transcript of the STAC meeting, March 28, 
2012:98, lines 23-31. http://www.cdc.gov/niosh/docket/archive/pdfs/NIOSH-248/0248-032812-transcript3.pdf. Accessed June 1, 2013.
    \17\ STAC (WTC Health Program Scientific/Technical Advisory 
Committee) [2012]. Letter from Elizabeth Ward, Chair to John Howard, 
MD, Administrator at 24. This letter is included in the docket for 
this rulemaking.
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    In evaluating whether to add prostate cancer based on Method 1, the 
Administrator considered the STAC's concerns about the findings of the 
one epidemiologic study that was available to review at the time, the 
Zeig-Owens study, which involved a small, heavily medically screened 
population. The Administrator agreed that surveillance bias could have 
explained the excess prostate cancer risk found in the study. In 
addition, as the STAC noted--and the Administrator agreed--the SIR for 
prostate cancer fell to 0.90 after correction for surveillance bias. 
The Administrator determined that, based on the information then 
available, the prostate cancer risk was not significantly increased 
over an appropriate reference population (Method 1). Additionally, no 
evidence existed for a causal association between prostate cancer and a 
condition already on the List (Method 2).
    As described above, the basis for adding a cancer according to the 
criteria in Method 3 is a determination by NTP that 9/11 exposures are 
known or reasonably anticipated to be human carcinogens, and a 
determination by IARC that sufficient or limited evidence in humans 
supports a causal association between a cancer and a 9/11 exposure. The 
STAC considered the determinations by NTP and IARC regarding the 
carcinogenicity of arsenic and cadmium and still voted not to recommend 
adding prostate cancer to the List. The Administrator was aware that 
two additional epidemiologic studies in 9/11-exposed populations were 
then in progress and might provide additional information about the 
association of prostate cancer and 9/11 exposures in the future. Given 
the STAC's decision not to recommend the addition of prostate cancer, 
which relied on the epidemiologic evidence available at that time, the 
Administrator determined that there was not a reasonable basis for 
adding prostate cancer to the List.

E. Petition 002

    On May 2, 2013, the Administrator received Petition 002 from the 
Patrolmen's Benevolent Association, a union representing New York City 
police officers. Petition 002 references, and relies upon, a study of 
over 25,000 WTC responders enrolled in the WTC Health Program, authored 
by Solan et al. and published in the scientific journal Environmental 
Health Perspectives.\18\ Petition 002 asserts that the Solan study:
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    \18\ Solan S, Wallenstein S, Shapiro M, Teitelbaum SL, Stevenson 
L, Kochman A, Kaplan J, Dellenbaugh C, Kahn A, Biro FN, Crane M, 
Crowley L, Gabrilove J, Gonsalves L, Harrison D, Herbert R, Luft B, 
Markowitz SB, Moline J, Niu X, Sacks H, Shukla G, Udasin I, Lucchini 
RG, Boffetta P, Landrigan PJ. [2013] Cancer incidence in World Trade 
Center rescue and recovery workers, 2001-2008. Environ Health 
Perspect 121(6):699-704.

[A]ffirms what was reported in prior published studies, that those 
exposed to the Ground Zero toxins are at higher risk of developing 
cancer than the general population. Notably, the Study found a 
statistically significant incidence rate for prostate cancer, 
including a 17% greater than expected rate of prostate cancer among 
responders. According to the Study, these findings were 
``concordant'' with the findings of the New York City Fire 
Department

[[Page 39674]]

[FDNY] and the New York City Department of Health and Mental Hygiene 
World Trade Center Health City Registry.\19\
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    \19\ The Petitioner incorrectly states that the Solan study 
reported a 17 percent increase in prostate cancer. Solan et al. 
report a 21 percent increase in prostate cancer when the timeframe 
for diagnosis is unrestricted, and 23 percent when the timeframe for 
diagnosis is restricted.

    The ``prior published studies'' referenced in Petition 002 were 
authored by Zeig-Owens et al., and by Li et al., published in the 
Journal of the American Medical Association (JAMA) in December 
2012.\20\ The Zeig-Owens, Li, and Solan studies are reviewed and 
analyzed by the Administrator below. In reviewing Petition 002, the 
Administrator is mindful of what the STAC stated in its April 2, 2012 
recommendation to the Administrator:
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    \20\ Li J, Cone JE, Kahn AR, Brackbill RM, Farfel MR, Greene CM, 
Hadler JL, Stayner LT, Stellman SD [2012]. Association Between World 
Trade Center Exposure and Excess Cancer Risk. JAMA 308(23):2479-
2488.

The Committee recognizes that additional epidemiologic studies will 
soon become available, and recommends that as they do become 
available, their findings be reviewed and modifications made to the 
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list as appropriate.

    Accordingly, the Administrator reviewed the two new epidemiologic 
studies in 9/11 exposed populations published subsequent to the 2011 
Zeig-Owens study. The Administrator's review focused on the information 
that the three epidemiologic studies, taken as a whole, provided on the 
question of the risk of prostate cancer in association with 9/11 
exposures and the role of surveillance bias in explaining any observed 
excess risk. The Administrator's findings regarding the three studies 
are described below, under Method 1.

IV. Administrator's Determination on Petition 002 Requesting the 
Addition of Prostate Cancer to the List

    In response to Petition 002, the Administrator has reviewed the 
available evidence pertinent to the four-part hierarchical methodology 
detailed above. The Administrator's review of the relevant evidence is 
below.

Method 1

    Method 1 requires that the Administrator evaluate the available 
information in published, peer-reviewed epidemiologic studies for 
evidence of an adequate strength of the association between 9/11 
exposure and a health effect (including the magnitude of the effect and 
its statistical significance), consistency of the findings across 
multiple studies, biological gradient, or dose (or exposure)-response 
relationships between 9/11 exposures and the cancer type, and 
plausibility and coherence with known facts about the biology of the 
cancer type.
    The Zeig-Owens study. The first published study of cancer outcomes 
associated with the 9/11 attacks was authored by Zeig-Owens et al. and 
published in September 2011. The study involved examination of the 
potential association between exposure and cancer outcomes among 9,853 
male Fire Department of the City of New York (FDNY) firefighters within 
7 years of September 11, 2001.\21\ The study evaluated cancer cases 
identified by self-reporting and through five state cancer registries. 
SIRs were used to determine if the number of observed cancer cases in 
the studied firefighters was greater or less than the number of cases 
expected to occur if the same disease rate in a large reference 
population occurred in the studied group.\22\ The reference cancer 
incidence data was obtained from the U.S. National Cancer Institute 
Surveillance Epidemiology and End Results (SEER) database.
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    \21\ Zeig-Owens et al. 2011.
    \22\ If the observed number of cancer cases equals the expected 
number of cases, the SIR equals 1 (one). If more cases are observed 
in the studied population than expected, the SIR is greater than 1 
(one). If fewer cases are observed in the studied population than 
expected, the SIR is less than 1.
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    In the Zeig-Owens study, the SIRs for various types of cancer, 
including prostate cancer, were reported in two ways: (1) By comparing 
the exposed FDNY firefighters to the general population; and (2) by 
comparing the SIR for 9/11 exposed FDNY firefighters to the SIR for 
non-9/11 exposed FDNY firefighters (the ratio of standardized incidence 
ratios is referred to as the ``SIR ratio''). When compared to the 
general population, the SIR for prostate cancer was increased, and that 
increase was statistically significant (SIR=1.49, 95% confidence 
interval (CI) 1.20-1.85). When compared to non-9/11 exposed FDNY 
firefighters, the SIR ratio was slightly greater than 1 (one),\23\ but 
the increase was not statistically significant (SIR ratio=1.11, 95% CI 
0.77-1.59). Zeig-Owens noted the potential for surveillance bias, that 
is, FDNY firefighters may be medically followed more closely or have 
more diagnostic tests performed than the general population, which 
could lead to finding more disease among this population.
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    \23\ If the SIR in the studied population equals the SIR in the 
reference population, the SIR ratio equals 1 (one). If the SIR in 
the studied population is greater than the SIR in the reference 
population, the SIR ratio is greater than 1 (one). If the SIR ratio 
in the studied population is less than the SIR in the reference 
population, the SIR ratio is less than 1 (one).
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    A standard method to adjust for surveillance bias is not available, 
and the adequacy of any adjustment method is uncertain. In an attempt 
to correct for surveillance bias, Zeig-Owens adjusted the SIRs and SIR 
ratios by delaying the recorded date of diagnosis by 2 years for 25 
cases of prostate and other cancers that potentially could be detected 
early by FDNY surveillance (i.e., medical screening). When the 
estimates were adjusted in this way, the comparison to the general 
population produced a SIR for prostate cancer that was increased, but 
not statistically significant (SIR=1.21, 95% CI 0.96-1.52). When 
compared to non-exposed firefighters, the SIR ratio was not increased 
(SIR ratio=0.90, 95% CI 0.62-1.30). The authors noted that they had 
gone to ``great lengths'' to assess and correct for potential biases 
and provided arguments against the existence of considerable bias. 
However, the authors further noted that delaying the date of diagnosis 
may have over-corrected or under-corrected for surveillance bias, and 
the authors could not rule out the potential for surveillance bias in 
several types of cancer, including prostate cancer.
    The Li study. Li et al. authored the second published epidemiologic 
study of cancer outcomes associated with the 9/11 attacks, published in 
December 2012. It involved examination of cancer health outcomes of 
55,778 members of the WTC Health Registry, including rescue and 
recovery workers as well as people not involved in rescue and recovery 
(e.g., area residents, workers, and passersby).\24\ In comparison to 
the Zeig-Owens study, the Li study involves a much larger and more 
heterogeneous population that is likely subjected to much less medical 
screening and surveillance bias.
---------------------------------------------------------------------------

    \24\ Li et al., 2012.
---------------------------------------------------------------------------

    In the Li study, cancer cases were identified through 11 state 
cancer registries; New York State cancer rates were used as the 
reference. The authors accounted for cancer latency by assuming that 
any exposure-related cancers would be more likely to occur at least 5 
years after the 9/11 exposures. The study population was divided into 
two groups: Early period (WTC Health Registry participants who were 
diagnosed with cancer between enrollment and 2006) and later period 
(WTC Health Registry participants who were diagnosed with cancer 
between 2007 and 2008). Among rescue and recovery workers, a 
statistically significant increase in the incidence of prostate cancer 
was reported for the

[[Page 39675]]

later period (SIR=1.43, 95% CI 1.11-1.82). In the early period, the SIR 
was slightly, but not statistically significantly, increased (SIR=1.12, 
95% CI 0.83-1.40).
    The potential for surveillance bias in the Li study was assessed 
by: (1) Comparing the number of Stage 1 cancers for selected cancer 
sites as a proportion of total cancer diagnoses in the study population 
to the corresponding proportion in the New York State reference 
population during the same period; and (2) comparing the proportion of 
participants who reported a routine physical checkup within the 
preceding 12 months to the number of follow-up participants with and 
without subsequent cancers. Importantly, the Li study noted that the 
proportions were similar in both cases and stated:

    These observations suggest that cancer cases in this study may 
not have received more thorough cancer screening than the NYS [New 
York State] population in general, although they do not eliminate 
the possible role of surveillance altogether. Also, our findings 
might be prone to type 1 error \25\ given the large number of 
comparisons.\26\
---------------------------------------------------------------------------

    \25\ A type 1 error is a ``false positive.'' In this case, the 
authors are noting that they made a large number of comparisons in 
the study and, when making a large number of comparisons, it is 
likely that some statistically significant findings will occur by 
chance.
    \26\ Li et al., at 2486.

    The Solan study. The third epidemiologic study of cancer outcomes 
in 9/11 exposed populations was authored by Solan et al. First 
published online in April 2013 and then in print in June of 2013, this 
study addressed cancer health outcomes associated with the 9/11 attacks 
involving 20,984 WTC responders (including rescue and recovery workers) 
enrolled in the WTC Health Program.\27\ Cancer cases diagnosed between 
2001 and 2008 were identified through the New York, New Jersey, 
Connecticut, and Pennsylvania cancer registries, and SIRs were 
calculated using the general population of the state of residence as 
the reference population. No adjustments were made for potential 
surveillance bias. When all prostate cancers diagnosed after September 
11, 2001 were included, a small statistically significant increase in 
the SIR for prostate cancer among WTC responders was observed (SIR = 
1.21, 95% CI 1.01-1.44). The authors note that, ``[e]vidence for 
occupational risk factors of prostate cancer is very weak, and 
heightened diagnosis due to increased medical surveillance is a 
possible explanation for greater than expected numbers of prostate 
cancer diagnoses.'' \28\ The SIR was also calculated for those WTC 
responders who were diagnosed with prostate cancer 6 months after 
enrollment in the WTC Health Program. This adjustment reduces the 
potential for selection bias \29\ in the results. After this 
adjustment, the SIR for prostate cancer remained increased, but was not 
statistically significant (SIR = 1.23, 95% CI 0.98-1.53).
---------------------------------------------------------------------------

    \27\ Solan et al., 2013.
    \28\ Solan et al., at 702.
    \29\ Selection bias might have occurred when individuals decided 
to enroll in the WTC Health Program after being diagnosed with 
prostate cancer. If this occurred, the number of prostate cancers 
among the exposed population would be increased and result in a 
higher SIR.
---------------------------------------------------------------------------

    When more than one epidemiologic study in 9/11 exposed populations 
has been published, Method 1 directs the Administrator to evaluate 
findings from the studies using the following criteria: (1) Strength of 
any association between a 9/11 exposure and a health effect (including 
the magnitude of the effect and statistical significance); (2) 
consistency of the findings across multiple studies; (3) biological 
gradient or dose-response relationships between 9/11 exposures and the 
cancer type; and (4) the plausibility and coherence with known facts 
about the biology of the cancer type. After review, the Administrator 
finds that the strength of the association between 9/11 exposures and 
prostate cancer across all three studies is weak (criteria 1), but that 
excess risk is consistently reported in each of the three studies 
(criteria 2). A dose (exposure)-response relationship between 9/11 
exposures and prostate cancer is difficult to establish because of the 
substantial limitations of 9/11 exposure information (criteria 3). 
Finally, there is limited evidence of the potential plausibility of the 
development of prostate cancer with two of the documented 9/11 
exposures--arsenic and cadmium (criteria 4). The Li study provides 
evidence that surveillance bias does not fully explain the observed 
excess risk for prostate cancer.
    Because surveillance bias may not explain all of the observed 
excess risk in studies of 9/11-exposed populations and because the 
strength of the association between 9/11 exposures and prostate cancer 
across all three studies is weak, the Administrator has determined that 
the evidence to add prostate cancer based on Method 1 is inconclusive.

Method 2

    Method 2 requires that the Administrator find that multiple 
epidemiologic studies show a causal association between a type of 
cancer and a health condition already on the List of WTC-Related Health 
Conditions. After review of the scientific literature, the 
Administrator finds that there is no evidence that any of the 
conditions on the List of WTC-Related Health Conditions increase the 
risk of prostate cancer and Method 3 should be reviewed.

Method 3

    Method 1 provides insufficient evidence to add prostate cancer to 
the List and Method 2 provides no evidence to add prostate cancer. The 
Administrator next reviewed 9/11 exposures in relation to NTP and IARC 
information pertinent to prostate cancer (Method 3).
    Arsenic and cadmium are 9/11 exposures that have been reported in 
several exposure assessment studies of responders or survivors of the 
September 11, 2001, terrorist attacks in New York City (Method 3A); 
\30\ and NTP identified arsenic and cadmium as known to be human 
carcinogens \31\ and IARC found limited \32\ evidence in humans that 
arsenic and cadmium cause prostate cancer (Method 3B). Based on the 
evidence provided in Methods 3A and 3B, the Administrator has 
determined that prostate cancer should be added to the List.
---------------------------------------------------------------------------

    \30\ Butt CM, Diamond ML, Truong J, Ikonomou MG, Helm PA, Stern 
GA [2004]. Semivolatile organic compounds in window films from lower 
Manhattan after the September 11th World Trade Center attacks. 
Environmental Science & Technology. 38(13):3514-3524.
    Lorber M, Gibb H, Grant L, Pinto J, Pleil J, Cleverly D [2007]. 
Assessment of inhalation exposures and potential health risks to the 
general population that resulted from the collapse of the World 
Trade Center towers. Risk Anal 27(5):1203-21.
    Lioy PJ, Gochfeld M [2002]. Lessons learned on environmental, 
occupational, and residential exposures from the attack on the World 
Trade Center. Am J Ind Med 42(6):560-565.
    \31\ NTP (National Toxicology Program) [2011]. 12th Report on 
Carcinogens. National Toxicology Program, Public Health Service, 
U.S. Department of Health and Human Services, Research Triangle 
Park, NC. http://ntp.niehs.nih.gov/?objectid=03C9AF75-E1BF-FF40-DBA9EC0928DF8B15. Accessed May 24, 2013.
    \32\ IARC (International Agency for Research on Cancer) [2012]. 
IARC Monographs on the Evaluation of the Carcinogenic Risks to 
Humans: Vol. 100C--Arsenic, Metals, Fibres, and Dusts. IARC, Lyon, 
France. http://monographs.iarc.fr/ENG/Monographs/vol100C/index.php. 
Accessed May 24, 2013.
---------------------------------------------------------------------------

Method 4

    Because Method 3 supports the addition of prostate cancer, Method 4 
is not analyzed.

Administrator's Determination

    Following review of all relevant evidence, the Administrator has

[[Page 39676]]

determined that the decision to not add prostate cancer in the 2012 
rulemaking is superseded by his new evaluation incorporating the Li and 
Solan study findings. The 2012 evaluation relied on the only 
epidemiologic study available at that time, Zeig-Owens, and the STAC's 
assessment of that study and vote to not include prostate cancer in 
their recommendation. The Li and Solan studies present epidemiologic 
findings from larger, more heterogeneous populations and present 
evidence that surveillance bias may not be occurring in the studied 
populations. Review of the two new studies leads the Administrator to 
believe that surveillance bias may not fully explain the increased 
incidence of prostate cancer and, accordingly, the Administrator can no 
longer attribute increased incidence of prostate cancer to surveillance 
bias with certainty. After comprehensive review of all three 
epidemiology studies of 9/11-exposed populations, the Administrator has 
determined that the epidemiologic evidence evaluated under Method 1 is 
inconclusive and therefore turns to evaluating the evidence of 
carcinogenicity provided by NTP and IARC under Method 3. The 
Administrator now finds that, based on the evidence provided in Methods 
3A and 3B, prostate cancer may be added to the named cancer types in 42 
CFR 88.1, Table 1.

V. Early Detection of Prostate Cancer

    Early detection of cancer in 9/11-exposed populations--either as 
part of medical monitoring of enrolled WTC responders and survivors or 
part of ongoing research--is an important adjunct to the WTC Health 
Program. The WTC Health Program adheres to the recommendations of the 
U.S. Preventive Services Task Force (USPSTF) with regard to coverage 
for preventive measures, including screening tests, counseling, 
immunizations, and preventive medications. The USPSTF recommends 
against PSA-based screening for prostate cancer.\33\ Therefore, PSA-
based screening for prostate cancer will not be covered by the WTC 
Health Program.
---------------------------------------------------------------------------

    \33\ U.S. Preventive Services Task Force. Recommendation: 
Screening for Prostate Cancer (2012). http://www.uspreventiveservicestaskforce.org/prostatecancerscreening.htm. 
Accessed June 2, 2013.
---------------------------------------------------------------------------

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

VII. Summary of Proposed Rule

    For the reasons discussed above, the Administrator proposes to 
amend 42 CFR 88.1, paragraph (4), Table 1, to add malignant neoplasm of 
the prostate (prostate cancer) and to add the corresponding medical 
diagnostic codes.\34\
---------------------------------------------------------------------------

    \34\ ICD-9 code 185 and ICD-10 code C61. See, respectively, WHO 
(World Health Organization) [1978]. International Classification of 
Diseases, Ninth Edition, and WHO [1997] International Classification 
of Diseases, Tenth Edition.
---------------------------------------------------------------------------

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. The 
proposed addition of prostate cancer by this rulemaking is estimated to 
cost the WTC Health Program between $3,462,675 \35\ and $6,995,817 \36\ 
per annum. All of the costs to the WTC Health Program will be transfers 
after the implementation of provisions of the Patient Protection and 
Affordable Care Act (Pub. L. 111-148) on January 1, 2014. This notice 
of proposed rulemaking has 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.
---------------------------------------------------------------------------

    \35\ Based on a population of 60,000 at the U.S. cancer rate and 
discounted at 7 percent.
    \36\ Based on a population of 110,000 at 21 percent above the 
U.S. cancer rate and discounted at 3 percent.
---------------------------------------------------------------------------

Cost Estimates
    The WTC Health Program has, to date, enrolled approximately 58,500 
WTC responders and approximately 6,500 survivors, or approximately 
65,000 individuals in total. Of that total population, approximately 
60,000 individuals were participants in previous WTC medical programs 
and were `grandfathered' into the WTC Health Program established by 
Title XXXIII.\37\ In addition to those grandfathered WTC responders and 
survivors already enrolled, the PHS Act sets a numerical limitation on 
the number of eligible members who can enroll in the WTC Health Program 
beginning July 1, 2011 at 25,000 new WTC responders and 25,000 new WTC 
survivors (i.e., the statute restricts new enrollment).\38\ Since July 
1, 2011, a total of approximately 3,000 new WTC responders and new WTC 
survivors (over 1,700 responders and 1,200 survivors) have enrolled in 
the WTC Health Program, resulting in only a minor impact on the 
statutory enrollment limits for new members. For the purpose of 
calculating a baseline estimate of cancer prevalence only, the 
Administrator assumed that this gradual rate of enrollment would 
continue, and that the currently enrolled population numbers would 
remain around 58,500 WTC responders and 6,500 WTC survivors. The 
estimate is further based on the average U.S. cancer prevalence rate 
and 7 percent discount rate.
---------------------------------------------------------------------------

    \37\ 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.''
    \38\ PHS Act, secs. 3311(a)(4)(A) and 3321(a)(3)(A).
---------------------------------------------------------------------------

    As it is not possible to identify an upper bound estimate, HHS has 
modeled another possible point on the continuum. For the purpose of 
calculating the impact of an increased rate of cancer on the WTC Health 
Program, this analysis assumes that the entire statutory cap for new 
WTC responders (25,000) and WTC survivors (25,000) will be filled. 
Accordingly, this estimate is based on a population of 80,000 
responders (55,000 grandfathered + 25,000 new) and 30,000 survivors 
(5,000 grandfathered + 25,000

[[Page 39677]]

new). The upper cost estimate also assumes an overall increase in 
population cancer rates (for malignant neoplasm of the prostate 
[prostate cancer] of 21 percent due to 9/11 exposure),\39\ and costs 
were discounted at 3 percent. The choice of a 21 percent increase in 
the risk of cancer of the rate found in the un-exposed population is 
based on findings presented in the first published epidemiologic study 
of September 11, 2001 exposed populations.\40\ Given the challenges 
associated with interpreting the Zeig-Owens findings,\41\ we simply 
characterize 21 percent as a possible outcome rather than asserting the 
probability that 21 percent is a ``likely'' outcome.
---------------------------------------------------------------------------

    \39\ Zeig-Owens R, Webber MP, Hall CB, Schwartz T, Jaber N, 
Weakley J, Rohan TE, Cohen HW, Derman O, Aldrich TK, Kelly K, 
Prezant DJ [2011]. Early Assessment of Cancer Outcomes in New York 
City Firefighters After the 9/11 Attacks: An Observational Cohort 
Study. Lancet. 378(9794):898-905.
    \40\ Zeig-Owens R, Webber MP, Hall CB, Schwartz T, Jaber N, 
Weakley J, Rohan TE, Cohen HW, Derman O, Aldrich TK, Kelly K, 
Prezant DJ [2011]. Early Assessment of Cancer Outcomes in New York 
City Firefighters After the 9/11 Attacks: An Observational Cohort 
Study. Lancet. 378(9794):898-905.
    \41\ As Zeig-Owens et al point out, the time interval since 9/11 
is short for cancer outcomes, the recorded excess of cancers is not 
limited to specific sites, and the biological plausibility of 
chronic inflammation as a possible mediator between WTC-exposure and 
cancer means that the outcomes remain speculative.
---------------------------------------------------------------------------

    The Administrator acknowledges that some prostate cancer cases are 
not likely to have been caused by 9/11 exposures. The certification of 
individual cancer diagnoses will be conducted on a case-by-case basis. 
However, for the purpose of this analysis, the Administrator has 
estimated that all diagnosed cancers added to the List will be 
certified for treatment by the WTC Health Program. Finally, because 
there are no existing data on cancer rates related to 9/11 exposures at 
either the Pentagon or in Shanksville, Pennsylvania, the Administrator 
has used only data from studies of individuals who were responders or 
survivors in the New York City disaster area.
Costs of Cancer Treatment
    The Administrator estimated the treatment costs associated with 
covering prostate cancer in this rulemaking using the methods described 
below. The WTC Health Program obtained data for the cost of providing 
medical treatment for prostate cancer.\42\ The costs of treatment are 
described in Table A. The costs of treatment are divided into three 
phases: The costs for the first year following diagnosis, the costs of 
intervening years or continuing treatment after the first year, and the 
costs of treatment for the last year of life. The first year costs of 
cancer treatment are higher due to the initial need for aggressive 
medical (e.g., radiation, chemotherapy) and surgical care. The costs 
during last year of life are often dominated by increased 
hospitalization costs.\43\ Therefore, we used three different treatment 
phase costs to estimate the costs of treatment to be able to best 
estimate costs in conjunction with expected incidence and long-term 
survival rates for prostate cancer.
---------------------------------------------------------------------------

    \42\ Yabroff KR, Lamont EB, Mariotto A, Warren JL, Topor M, 
Meekins A, Brown ML [2008]. Cost of Care for Elderly Cancer Patients 
in the United States. Journal: J Natl Cancer Inst 100(9):630-41.
    \43\ Yabroff KR, Lamont EB, Mariotto A, Warren JL, Topor M, 
Meekins A, Brown ML [2008]. Cost of Care for Elderly Cancer Patients 
in the United States. Journal: J Natl Cancer Inst 100(9):630-41.

     Table A--Average Costs of Treatment for Prostate Cancer (2011$)
------------------------------------------------------------------------
                                                           Last year  of
           Initial  (12 month)              Continuing       life  (12
                                             (annual)          mos.)
------------------------------------------------------------------------
$13,696.................................          $2,754         $43,481
------------------------------------------------------------------------

    These cost figures were based on a study of elderly cancer patients 
from the Surveillance, Epidemiology, and End Results (SEER) program 
maintained by the National Cancer Institute using Medicare files.\44\ 
The average costs of treatment described above are given in 2011 prices 
adjusted using the Medical Consumer Price Index for all urban 
consumers.\45\
---------------------------------------------------------------------------

    \44\ Surveillance, Epidemiology, and End Results (SEER) Program 
(www.seer.cancer.gov) Research Data (1973-2006), National Cancer 
Institute, DCCPS, Surveillance Research Program, Surveillance 
Systems Branch, released April 2009, based on the November 2008 
submission.
    \45\ Bureau of Labor Statistics. Consumer Price Index. Available 
at https://research.stlouisfed.org/fred2/series/CPIMEDSL/downloaddata?cid=32419. Accessed April 23, 2012.
---------------------------------------------------------------------------

Incident Cases of Cancer
    The Administrator estimated the expected number of cases of cancer 
that would be observed in a cohort of responders and survivors followed 
for cancer incidence after September 11, 2001 using U.S. population 
cancer rates for prostate cancer. Demographic characteristics of the 
cohort were assigned since the actual data are not available for 
individuals in the responder and survivor populations who have not yet 
enrolled in the WTC Health Program. Gender and age (at the time of 
exposure) distributions for responders and survivors were assumed to be 
the same as current members in the WTC Health Program. According to WTC 
Health Program data, males comprise 88 percent of the current responder 
members and 50 percent of survivor members. Because prostate cancer 
occurs only in males, all calculations only take into account male WTC 
Health Program members. The age distribution for current members by 
gender and responder/survivor status is presented in Table B.

 Table B--Percentiles of Current Age (on April 11, 2012) for Current Members in the WTC Health Program by Gender
                                          and Responder/Survivor Status
----------------------------------------------------------------------------------------------------------------
                                                              Age percentile (years)
             Group              --------------------------------------------------------------------------------
                                   Min       1        10       30       50       70       90       99      Max
----------------------------------------------------------------------------------------------------------------
Male responders................       28       32       39       44       49       54       62       74       92
Female responders..............       28       30       38       44       49       54       62       76       92
Male survivors.................       12       23       35       46       52       58       67       81       99
Female survivors...............       12       21       38       49       54       60       68       84       95
----------------------------------------------------------------------------------------------------------------

    The Administrator assumed race and ethnic origin distributions for 
responders and survivors according to distributions in the WTC Health 
Registry cohort: \46\ 57 percent non-Hispanic white, 15 percent non-

[[Page 39678]]

Hispanic black, 21 percent Hispanic, and 8 percent other race/ethnicity 
for responders and 50 percent non-Hispanic white, 17 percent non-
Hispanic black, 15 percent Hispanic, and 18 percent other race/
ethnicity for survivors. Follow-up for cancer morbidity for each person 
began on January 1, 2002 or age 15 years, whichever was later. Age 15 
was considered because the cancer incidence rate file did not include 
rates for persons less than 15 years of age. Follow-up ended on 
December 31, 2016 or the estimated last year of life, whichever was 
earlier. The estimated last year of life was used since not all persons 
would be expected to remain alive at the end of 2016. The estimated 
last year of life was based on U.S. gender, race, age, and year-
specific death rates from CDC Wonder (since rates are currently 
available through 2008, the rate from 2008 was applied to 2009 and 
later).\47\ A life-table analysis program, LTAS.NET, was used to 
estimate the expected number of incident cancers for prostate 
cancer.\48\ The Administrator calculated cancer incidence rates using 
data through 2006 from the Surveillance Epidemiology and End Results 
(SEER) Program and estimated rates for 2007-2016.\49\ The Program 
applied the resulting gender, race, age, and year-specific cancer 
incidence rates to the estimated person-years at risk to estimate the 
expected number of cancer cases for prostate cancer starting from year 
2002, the first full year following the September 11, 2001, terrorist 
attacks, to 2016, the last year for which this Program is currently 
funded.
---------------------------------------------------------------------------

    \46\ Jordan HT, Brackbill RM, Cone JE, Debchoudhury I, Farfel 
MR, Greene CM, Hadler JL, Kennedy J, Li J, Liff J, Stayner L, 
Stellman SD. Mortality Among Survivors of the Sept 11, 2001, Word 
Trade Center Disaster: Results from the World Trade Center Health 
Registry Cohort. Lancet 2011;378:879-887. Note: percentages may not 
sum to 100 percent due to rounding.
    \47\ Centers for Disease Control and Prevention, National Center 
for Health Statistics. Compressed Mortality File 1999-2008. CDC 
WONDER Online Database, compiled from Compressed Mortality File 
1999-2008 Series 20 No. 2N, 2011. http://wonder.cdc.gov/cmf-icd10.html. Accessed February 15, 2012.
    \48\ Schubauer-Berigan MK, Hein MJ, Raudabaugh WM, Ruder AM, 
Silver SR, Spaeth S, Steenland K, Petersen MR, and Waters KM [2011]. 
Update of the NIOSH Life Table Analysis System: A Person-Years 
Analysis program for the Windows Computing Environment. American 
Journal of Industrial Medicine 54:915-924.
    \49\ National Cancer Institute, Surveillance Epidemiology and 
End Results (SEER). http://seer.cancer.gov/. Accessed May 27, 2012.
---------------------------------------------------------------------------

Prevalence of Cancer
    To determine the potential number of persons in the responder and 
survivor populations with cancer, the Administrator used the number of 
incident cases described above for each year starting with 2002 and 
estimated the prevalence of cancer using survival rate statistics for 
each incident cancer group through 2016.\50\ Using the incident cases 
and survival rate statistics, HHS has estimated the prevalence (number 
of persons living with cancer) of cases during the 15 year period 
(2002-2016) since September 11, 2001. The resulting table provides for 
each year from 2002 through 2016, the number of new cases occurring in 
that year (incidence), the number of individuals who died from their 
cancer in that year, and the number of persons surviving up to 15 years 
beyond their first diagnosis (prevalence).\51\ For example, in 2002 
there are 34.22 projected new cases of prostate cancer, which would be 
listed as incident cases for that year. The survival rate for prostate 
cancer in the first year of diagnosis is 99.44 percent.\52\ Therefore 
the number of deceased persons in 2002 would be 34.22 x (1 - 0.9944) = 
0.19. For the prostate cancer prevalence table, in year 2003, the 
number of incident cases would be 38.55 cases. In addition to 38.55 
newly diagnosed cases in 2003, there would be the one-year survivors 
from 2002 which would be 34.22 - 0.19 = 34.03 cases. This computation 
process can be repeated for each year through year 2016. A portion of 
the prostate cancer prevalence tables are provided in Table C. 
Prevalence is summarized in Tables E and G. This analysis considers 
cancers diagnosed in 2002 through 2016.
---------------------------------------------------------------------------

    \50\ National Cancer Institute, Surveillance Epidemiology and 
End Results (SEER). http://seer.cancer.gov/. Accessed May 27, 2012.
    \51\ The 15-year survival limit is imposed based on the analytic 
time horizon.
    \52\ National Cancer Institute, Surveillance Epidemiology and 
End Results (SEER). http://seer.cancer.gov/. Accessed May 27, 2012.

                                                      Table C--Prevalence Table for Prostate Cancer
                                                              [Based on 80,000 responders]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                           Year                  Years since 9/11 exposure             Years covered by WTC Health Program
                                                     ------------------------------------------------------------------------------------------------------
                                                         New/Surv.         2002            2003            2013            2014            2015       2016
---------------------------------------------------------------------------------------------------------------------------------------------------- ------
1...................................................           34.22           38.55          112.54          123.98          134.46          146.33
2...................................................  ..............           34.03          100.76          111.92          123.29          133.72
3...................................................  ..............  ..............           88.67           99.55          110.57          121.81
4...................................................  ..............  ..............           79.02           87.58           98.33          109.22
5...................................................  ..............  ..............           71.15           78.61           87.13           97.82
6...................................................  ..............  ..............           63.27           70.41           77.80           86.23
7...................................................  ..............  ..............           55.71           62.74           69.83           77.15
8...................................................  ..............  ..............           48.22           55.06           62.01           69.01
9...................................................  ..............  ..............           42.10           47.91           54.71           61.61
10..................................................  ..............  ..............           39.77           41.51           47.24           53.95
11..................................................  ..............  ..............           35.02           39.38           41.11           46.77
12..................................................  ..............  ..............           30.91           34.83           39.17           40.88
13..................................................  ..............  ..............  ..............           30.43           34.29           38.56
14..................................................  ..............  ..............  ..............  ..............           30.26           34.10
15..................................................  ..............  ..............  ..............  ..............  ..............           30.06
Live cases from previous years......................            0.00           34.03          654.61          759.95          875.74         1000.89
Prevalence..........................................           34.22           72.58          767.15          883.93         1010.20         1147.22
Last year of life...................................            0.19            0.62            7.20            8.19            9.31           10.65
--------------------------------------------------------------------------------------------------------------------------------------------------------

Cost Computation
    To compute the costs for prostate cancer, the Administrator assumes 
that all of the individuals who are diagnosed with prostate cancer will 
be certified by the WTC Health Program for treatment and monitoring 
services. The treatment costs for the first year of treatment (Table A, 
year adjusted) were applied to

[[Page 39679]]

the predicted newly incident (Year 1) cases for each year. Likewise, 
the costs of treatment for the last year of life were applied in each 
year to the number of people predicted to die from their cancer in that 
year. The costs of continuing treatment from Table A were applied to 
the number of prevalent cases who had survived their cancers beyond 
their year of diagnosis, for each year of survival (Year 2-15).
    Using this procedure, a cost table was constructed for each year 
covered by the WTC Health Program and the results are presented in 
Table D. The row for Year 1 in each table is the cost of incident cases 
for that year. Rows for years 2-15 show the cost from continuing care 
for persons surviving n-years beyond the year of diagnosis. Finally, 
the cost of last year of life treatment is computed by multiplying the 
cost for last year of life from Table A by the number of persons dying 
in that year from prostate cancer from Table C.

                          Table D--Cost per 80,000 Responders for Prostate Cancer, 2011$
----------------------------------------------------------------------------------------------------------------
                                                                      Years covered by the WTC Health Program
                              Year                               -----------------------------------------------
                                                                       2014            2015            2016
----------------------------------------------------------------------------------------------------------------
1...............................................................      $1,688,586      $1,831,435      $1,993,026
2...............................................................         308,251         339,563         368,289
3...............................................................         274,159         304,530         335,464
4...............................................................         241,216         270,809         300,809
5...............................................................         216,509         239,972         269,413
6...............................................................         193,930         214,266         237,486
7...............................................................         172,786         192,305         212,470
8...............................................................         151,653         170,779         190,071
9...............................................................         131,942         150,680         169,685
10..............................................................         114,331         130,098         148,574
11..............................................................         108,466         113,209         128,822
12..............................................................          95,925         107,868         112,586
13..............................................................          83,816          94,438         106,196
14..............................................................  ..............          83,345          93,906
15..............................................................  ..............  ..............          82,779
Prevalent care..................................................       3,781,570       4,243,298       4,666,796
Last year of life care..........................................         356,227         404,804         463,183
                                                                 -----------------------------------------------
    Total.......................................................       4,137,798       4,648,102       5,129,979
----------------------------------------------------------------------------------------------------------------

    The sum of the annual costs in the table for the years 2014 through 
2016 represents the estimated treatment costs to the WTC Health Program 
for coverage of prostate cancer for 80,000 responders. The same process 
described above was applied to the survivor cohort. Based on the 
incidence rate expected from the survivor cohort, prevalence tables 
were constructed. The estimated treatment costs for responders and 
survivors were re-computed under the following two assumptions: (1) The 
rate of cancer in the WTC Health Program is equal to the rate of cancer 
observed in the general population; and (2) the rate of cancer exceeds 
the general population rate by 21 percent due to their WTC 
exposures.\53\
---------------------------------------------------------------------------

    \53\ Zeig-Owens R, Webber MP, Hall CB, Schwartz T, Jaber N, 
Weakley J, Rohan TE, Cohen HW, Derman O, Aldrich TK, Kelly K, 
Prezant DJ [2011]. Early Assessment of Cancer Outcomes in New York 
City Firefighters After the 9/11 Attacks: An Observational Cohort 
Study. Lancet. 378(9794):898-905. Limitations of the Zeig-Owens 
study include: limited information on specific exposures experienced 
by firefighters; short time for follow-up of cancer outcomes; 
speculation about the biological plausibility of chronic 
inflammation as a possible mediator between WTC-exposure and cancer 
outcomes; and potential unmeasured confounders.
---------------------------------------------------------------------------

    A summary of the estimated prevalence at the U.S. population 
average for the assumed population of 58,500 responders and 6,500 
survivors is provided in Table E. A summary of the estimated treatment 
costs to the WTC Health Program is provided in Table F. A summary of 
the estimated prevalence using cancer rates 21 percent over the U.S. 
population average for the increased rate of 80,000 responders and 
30,000 survivors is given in Table G. A summary of the estimated 
treatment costs to the WTC Health Program is provided in Table H.

    Table E--Estimated Prevalence of Prostate Cancer by Year Based on 58,500 and 6,500 Responder and Survivor
                  Population, Respectively and Assuming Cancer Rates at U.S. Population Average
----------------------------------------------------------------------------------------------------------------
                                                                        Prevalence (incident + live cases)
                           Population                            -----------------------------------------------
                                                                       2014            2015            2016
----------------------------------------------------------------------------------------------------------------
Based on 58,500 responders......................................          646.37          738.71          838.90
Based on 6,500 survivors........................................           65.95           73.93           82.41
----------------------------------------------------------------------------------------------------------------


[[Page 39680]]


 Table F--Estimated Treatment Costs of Prostate Cancer by Year Based on 58,500 and 6,500 Responder and Survivor
             Population, Respectively and Assuming Cancer Rates at U.S. Population Average (2011 $)
----------------------------------------------------------------------------------------------------------------
                   Population                          2014            2015            2016          2014-2016
----------------------------------------------------------------------------------------------------------------
Based on 58,500 responders......................       3,025,765       3,398,924       3,751,298      10,175,987
Based on 6,500 survivors........................         296,297         326,642         352,170         975,109
----------------------------------------------------------------------------------------------------------------


   Table G--Estimated Prevalence of Prostate Cancer by Year Based on 80,000 and 30,000 Responder and Survivor
  Population, Respectively and Assuming Incidence of Cancer is 21% Higher Than the U.S. Population Due to 9/11
                                                    Exposure
----------------------------------------------------------------------------------------------------------------
                                                                        Prevalence (incident + live cases)
                           Population                            -----------------------------------------------
                                                                       2014            2015            2016
----------------------------------------------------------------------------------------------------------------
Based on 80,000 responders......................................         1069.55         1222.34         1388.13
Based on 30,000 survivors.......................................          368.31          412.86          460.19
----------------------------------------------------------------------------------------------------------------


 Table H--Estimated Treatment Costs of Prostate Cancer by Year Based on 80,000 and 30,000 Responder and Survivor
  Population, Respectively and Assuming Incidence of Cancer is 21% Higher Than the U.S. Population Due to 9/11
                                                Exposure (2011 $)
----------------------------------------------------------------------------------------------------------------
                   Population                          2014            2015            2016          2014-2016
----------------------------------------------------------------------------------------------------------------
Based on 80,000 responders......................      $5,089,491      $5,717,165      $6,309,875     $17,116,531
Based on 30,000 survivors.......................       1,378,925       1,520,138       1,638,947       4,538,010
----------------------------------------------------------------------------------------------------------------

Summary of Costs
    Because HHS lacks data to account for recoupment by workers' 
compensation insurance or reduction by either health insurance or 
Medicare/Medicaid payments, the estimates offered here are reflective 
of estimated WTC Health Program costs only. This analysis offers an 
assumption about the number of individuals who might enroll in the WTC 
Health Program and estimates the impact of both a low rate of cancer 
(U.S. population average rate) and an increased rate (21 percent 
greater than the U.S. population average) on the number of cases and 
the resulting estimated treatment costs to the WTC Health Program. This 
analysis does not include administrative costs associated with 
certifying additional diagnoses of cancers that are WTC-related health 
conditions that might result from this action. Those costs were 
addressed in the interim final rule that established regulations for 
the WTC Health Program (76 FR 38914, July 1, 2011).
    After the implementation of provisions of the Affordable Care Act 
on January 1, 2014, all of the members and future members can be 
assumed to have or have access to medical insurance coverage other than 
through the WTC Health Program. Therefore, all treatment and screening 
costs to be paid by the WTC Health Program from 2014 through 2016 are 
considered transfers. Table I describes the allocation of WTC Health 
Program transfer payments based on 58,500 responders and 6,500 
survivors and, alternatively, 80,000 responders and 30,000 survivors.

 Table I--Breakdown of Estimated Annual WTC Health Program Transfers for
  Prostate Cancer Based on 80,000 and 58,500 Responders and 30,000 and
                    6,500 Survivors, 2014-2016, 2011$
------------------------------------------------------------------------
                                        Annualized transfers for 2014-
                                                 2016, 2011 $
                                     -----------------------------------
                                       Discounted at 7   Discounted at 3
                                           percent           percent
------------------------------------------------------------------------
                                                  Cancer Rate
------------------------------------------------------------------------
                                        U.S. average     U.S. average +
                                                               21%
------------------------------------------------------------------------
58,500 Responders...................        $3,159,619  ................
6,500 Survivors.....................           303,056  ................
    65,000 Total....................        $3,462,675  ................
80,000 Responders...................  ................        $5,529,266
30,000 Survivors....................  ................         1,466,551
    110,000 Total...................  ................         6,995,817
------------------------------------------------------------------------

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 prostate cancer patients 
treated through the WTC Health Program, compared to no Program. The 
assessment of the

[[Page 39681]]

health benefits for prostate cancer patients uses the number of 
expected cancer cases that was estimated in the cost analysis section.
    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. In addition, the 
Administrator has only limited information about health insurance and 
health care services for prostate cancers potentially caused by 9/11 
exposures and suffered by any population of responders and survivors, 
including responders and survivors currently enrolled in the WTC Health 
Program and responders and survivors not enrolled in the Program. For 
the purposes of this analysis, the Administrator assumes that broad 
trends on demographics and access to health insurance reported by the 
U.S. Census Bureau and health care services for cancer similar to those 
reported by Ward et al. \54\ would apply to the population of general 
responders (those individuals who are not members of the FDNY and who 
meet the eligibility criteria in 42 CFR Part 88 for WTC responders) and 
survivors both within and outside the Program. For the purposes of this 
analysis, the Administrator assumes that access to health insurance and 
health care services for FDNY responders within and outside the Program 
would be equivalent because this population is overwhelmingly covered 
by employer-based health insurance.
---------------------------------------------------------------------------

    \54\ Ward E, Halpern M, Schrag N, Cokkinides V, DeSantis C, 
Bandi P, Siegel R, Stewart A, Jemal A [2008]. Association of 
Insurance with Cancer Care Utilization and Outcomes. CA Cancer J 
Clin 58:9-31.
---------------------------------------------------------------------------

    Although the Administrator cannot quantify the benefits associated 
with the WTC Health Program, members with prostate cancer would have 
improved access to care and thereby the Program should produce better 
treatment outcomes than in its absence. Under other insurance plans, 
patients would have deductibles and copays, which impact access to care 
and particularly its timeliness.\55\ WTC Health Program members would 
have first-dollar coverage and hence are likely to seek care sooner 
when indicated, resulting in improved treatment outcomes.
---------------------------------------------------------------------------

    \55\ Wharam JF, Galbraith AA, Kleinman KP, Soumerai SB, Ross-
Degnan D, Landon BE. Cancer Screening before and after Switching to 
a High-Deductible Health Plan. Annals of Internal Medicine. 2008 
May;148(9):647-655.
---------------------------------------------------------------------------

Limitations
    The analysis presented here was limited by the dearth of verifiable 
data on the prostate cancer 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 administrative costs, or 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 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. Data collection and 
recordkeeping requirements for the WTC Health Program are approved by 
OMB under ``World Trade Center Health Program Enrollment, Appeals & 
Reimbursement'' (OMB Control No. 0920-0891, exp. December 31, 2014). 
The Administrator has determined that no changes are needed to the 
information collection request already approved by OMB.

D. Small Business Regulatory Enforcement Fairness Act

    As required by Congress under the Small Business Regulatory 
Enforcement Fairness Act of 1996 (5 U.S.C. 801 et seq.), HHS will 
report the promulgation of this rule to Congress prior to its effective 
date.

E. Unfunded Mandates Reform Act of 1995

    Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531 
et seq.) directs agencies to assess the effects of Federal regulatory 
actions on State, local, and Tribal governments, and the private sector 
``other than to the extent that such regulations incorporate 
requirements specifically set forth in law.'' For purposes of the 
Unfunded Mandates Reform Act, this proposed rule does not include any 
Federal mandate that may result in increased annual expenditures in 
excess of $100 million 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). For 2013, the inflation adjusted threshold is $150 million.

F. Executive Order 12988 (Civil Justice)

    This proposed rule has been drafted and reviewed in accordance with 
Executive Order 12988, ``Civil Justice Reform,'' and will not unduly 
burden the Federal court system. This rule has been reviewed carefully 
to eliminate drafting errors and ambiguities.

G. Executive Order 13132 (Federalism)

    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.

[[Page 39682]]

Proposed Rule

List of Subjects in 42 CFR Part 88:

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

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

PART 88--WORLD TRADE CENTER HEALTH PROGRAM

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, the under the definition ``List of WTC-related health 
conditions'', following paragraph (4), revise Table 1 to read as 
follows:


Sec.  88.1  Definitions.

* * * * *
    List of WTC-related health conditions * * *
    (4) * * *
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    Dated: June 26, 2013.
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. 2013-15816 Filed 7-1-13; 8:45 am]
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