```

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

[[Page 35573]]

Vol. 77

Wednesday,

No. 114

June 13, 2012

Part IV

Department of Health and Human Services

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42 CFR Part 88

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

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

[[Page 35574]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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

42 CFR Part 88

RIN 0920-AA49

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

AGENCY: Centers for Disease Control and Prevention, HHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: Title I of the James Zadroga 9/11 Health and Compensation Act 
of 2010 amended the Public Health Service Act (PHS Act) to establish 
the World Trade Center (WTC) Health Program. The WTC Health Program, 
which is administered by the Director of the National Institute for 
Occupational Safety and Health (NIOSH), within the Centers for Disease 
Control and Prevention (CDC), provides medical monitoring and treatment 
to eligible firefighters and related personnel, law enforcement 
officers, and rescue, recovery, and cleanup workers who responded to 
the September 11, 2001, terrorist attacks in New York City, at the 
Pentagon, and in Shanksville, Pennsylvania, and to eligible survivors 
of the New York City attacks. In accordance with our regulations, which 
establish procedures for adding a new condition to the list of health 
conditions covered by the WTC Health Program, this proposed rule would 
add certain types of cancer to the List of WTC-Related Health 
Conditions.

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

ADDRESSES: Written Comments: You may submit comments by any of the 
following methods:
     Federal eRulemaking Portal: 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.
     Facsimile: (513) 533-8285.
    Instructions: All submissions received must include the agency name 
(Centers for Disease Control and Prevention, HHS) and docket number 
(CDC-2012-007; NIOSH-257) or Regulation Identifier Number (0920-AA49) 
for this rulemaking. All relevant comments, including any personal 
information provided, will be posted without change to 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 or http://www.cdc.gov/niosh/docket/archive/docket257.html.

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

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

I. Executive Summary
    A. Purpose of Regulatory Action
    B. Summary of Major Provisions
    C. Costs and Benefits
II. Public Participation
III. Background
    A. WTC Health Program Statutory Authority
    B. Addition of Health Conditions to the List of WTC-Related 
Health Conditions
    C. Need for Rulemaking
    D. Addition of Certain Types of Cancer to the List of WTC-
Related Health Conditions
    1. Scientific/Technical Advisory Committee (STAC) 
Recommendations
    2. Administrator's Review of Available Scientific Information 
and the STAC's Recommendations
    3. Methods Used by the Administrator to Determine Whether to Add 
Cancer or Types of Cancer to the List of WTC-Related Health 
Conditions
    4. Administrator's Determination Concerning Petition 001
    5. Explanations for Adding Certain Types of Cancer to the List 
of WTC-Related Health Conditions
    6. Certification and Treatment of WTC-Related Health Conditions 
Including Types of Cancer
    7. Endnotes
    E. Effects of Rulemaking on Federal Agencies
IV. Summary of Proposed Rule
V. Regulatory Assessment Requirements
    A. Executive Order 12866 and Executive Order 13563
    B. Regulatory Flexibility Act
    C. Paperwork Reduction Act
    D. Small Business Regulatory Enforcement Fairness Act
    E. Unfunded Mandates Reform Act of 1995
    F. Executive Order 12988 (Civil Justice)
    G. Executive Order 13132 (Federalism)
    H. Executive Order 13045 (Protection of Children from 
Environmental Health Risks and Safety Risks)
    I. Executive Order 13211 (Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use)
    J. Plain Writing Act of 2010
VI. Proposed Rule

I. Executive Summary

A. Purpose of Regulatory Action

    Title I of the James Zadroga 9/11 Health and Compensation Act of 
2010 (Pub. L. 111-347), amended the Public Health Service Act (PHS Act) 
establishing the World Trade Center (WTC) Health Program within the 
Department of Health and Human Services (HHS). The PHS Act requires the 
WTC Program Administrator (Administrator) to conduct rulemaking to 
propose the addition of a health condition to the List of WTC-Related 
Health Conditions (List) codified in 42 CFR 88.1 whether the 
Administrator adds a health condition based on the findings from 
periodic reviews of cancer,\1\ based on a request from a petition, or 
based on a determination made at the Administrator's discretion that a 
proposed rule adding a condition should be initiated. Following a 
petition to add cancer or certain types of cancer to the List and a 
recommendation by the WTC Health Program's Scientific/Technical 
Advisory Committee (STAC), the Administrator is following the 
procedures established in 42 CFR 88.17 to add some, but not all types 
of cancer recommended by the petition.
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    \1\ See PHS Act, Title XXXIII Sec.  3312(a)(5).
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B. Summary of Major Provisions

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

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

[[Page 35575]]

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

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

C. Costs and Benefits

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

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

II. Public Participation

    Interested persons or organizations are invited to participate in 
this rulemaking by submitting written views, opinions, recommendations, 
and data. Comments received, including attachments and other supporting 
materials, are part of the public record and subject to public 
disclosure. Do not include any information in your comment or 
supporting materials that you consider confidential or inappropriate 
for public disclosure. Comments are invited on any topic related to 
this proposed rule. The Administrator is seeking comments from the 
public on the following specific topics:
    1. The four methods proposed to evaluate evidence for the addition 
of types of cancer to the List of WTC-Related Health Conditions;
    2. Information or published studies about the type of welding that 
occurred in the New York City disaster area, at the Pentagon, or at 
Shanksville, Pennsylvania with regard to metal

[[Page 35576]]

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

III. Background

A. WTC Health Program Statutory Authority

    Title I of the James Zadroga 9/11 Health and Compensation Act of 
2010 (Pub. L. 111-347), amended the Public Health Service Act (PHS Act) 
to add Title XXXIII \2\ establishing the World Trade Center (WTC) 
Health Program within the Department of Health and Human Services 
(HHS). The WTC Health Program provides medical monitoring and treatment 
benefits to eligible firefighters and related personnel, law 
enforcement officers, and rescue, recovery, and cleanup workers who 
responded to the September 11, 2001, terrorist attacks in New York 
City, at the Pentagon, and in Shanksville, Pennsylvania, and to 
eligible survivors of the New York City attacks.
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    \2\ Title XXXIII of the Public Health Service Act is codified at 
42 U.S.C. 300mm to 300mm-61. Those portions of the Zadroga Act found 
in Titles II and III of Public Law 111-347 do not pertain to the 
World Trade Center Health Program and are codified elsewhere.
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    All references to the Administrator of the WTC Health Program 
(Administrator) in this notice mean the NIOSH Director or his or her 
designee. Title XXXIII, Sec.  3312(a)(6) of the PHS Act requires the 
Administrator to conduct rulemaking to propose the addition of a health 
condition to the List of WTC-Related Health Conditions (List) codified 
in 42 CFR 88.1.

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

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

C. Need for Rulemaking

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

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

    To determine whether the scientific evidence is sufficient to 
support the addition of cancer or types of cancer to the List of WTC-
Related Health Conditions, the Administrator considered data from five 
information sources: (1) Peer-reviewed studies published in the 
scientific literature, including environmental sampling data, 
epidemiologic studies on the 9/11 exposed populations, and studies 
providing evidence of a causal relationship between a type of cancer 
and a condition already on the List of WTC-Related Health Conditions; 
(2) findings and recommendations solicited from the WTC Clinical 
Centers of Excellence and Data Centers, the WTC Health Registry at the 
New York City Department of Health and Mental Hygiene, and the New York 
State Department of Health; (3) information from the public solicited 
through a request for information published in the Federal Register on 
March 8, 2011 and March 29, 2011; (4) the findings of the National 
Toxicology Program (NTP) in the National Institute of Environmental 
Health Sciences, HHS, as well as the World Health Organization's 
International Agency for Research on Cancer (IARC); and (5) findings 
from other sources of information relevant to 9/11 exposures, including 
the expert judgment and personal experiences of STAC members, and 
comments from the public.
    NTP, an interagency program that evaluates agents of public health 
concern using toxicology and molecular biology, publishes the biennial 
Report on Carcinogens (RoC), which contains a list of human 
carcinogens, exposure information, and descriptions of Federal exposure 
limits.\3\ The RoC classifies agents in one of two ways: known to be a 
human carcinogen, and reasonably anticipated to be a human carcinogen; 
this classification is determined by an expert panel convened for each 
candidate substance and is based on an evaluation of the published, 
peer-reviewed literature and reviews conducted by Federal agencies and 
IARC. Unlike IARC, NTP does not identify specific types of cancer that 
have sufficient evidence of carcinogenicity.
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    \3\ NTP Report on Carcinogens (RoC). http://ntp.niehs.nih.gov/?objectid=72016262-BDB7-CEBA-FA60E922B18C2540. Accessed May 9, 2012.
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    IARC, which coordinates and conducts research on the causes of 
human cancer and the mechanisms of carcinogenesis, maintains a series 
of

[[Page 35577]]

Monographs on the carcinogenic risks to humans caused by chemicals, 
complex mixtures, occupational exposures, physical agents, biological 
agents, and lifestyle factors. In the Monographs, carcinogens are 
categorized according to whether they provide sufficient evidence of 
carcinogenicity in humans for a certain type of cancer (Group 1); or 
limited evidence of carcinogenicity in humans, including agents 
probably carcinogenic to humans (Group 2A) and agents possibly 
carcinogenic to humans (Group 2B); whether they are not classifiable as 
to carcinogenicity in humans (Group 3); or whether there is evidence 
suggesting lack of carcinogenicity (Group 4).\4\ IARC convenes working 
groups of international experts to develop each Monograph based on 
reviews of epidemiological, animal, and mechanistic data ``that have 
been published or accepted for publication in the openly available 
scientific literature,'' although ``[i]n certain instances, government 
agency reports that have undergone peer review and are widely available 
are considered.'' [IARC 2006]
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    \4\ WHO International Agency for Research on Cancer (IARC). 
http://monographs.iarc.fr/. Accessed May 8, 2012.
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    In July 2011, the Administrator released the First Periodic Review 
of the Scientific and Medical Evidence Related to Cancer for the World 
Trade Center Health Program (First Periodic Review). [NIOSH 2011] As 
required by Title XXXIII, Sec.  3312(a)(5)(A) of the PHS Act, the 
Administrator reviewed ``all available scientific and medical evidence, 
including findings and recommendations of Clinical Centers of 
Excellence, published in peer-reviewed journals to determine if, based 
on such evidence, cancer or a certain type of cancer should be added to 
the applicable list of WTC-related health conditions.'' As described in 
the First Periodic Review, environmental sampling identified 287 
chemicals and chemical groups as present in the New York City disaster 
area (referred to herein as ``9/11 agents'' \5\). [COPC 2003] Published 
exposure assessments reviewed by the Administrator in the First 
Periodic Review ``suggest that responders and others in the nearby area 
were potentially exposed to one or more of the substances designated by 
IARC and NTP as known or reasonably anticipated human carcinogens, 
although generally not in excess of applicable occupational exposure 
limits.'' [NIOSH 2011]
---------------------------------------------------------------------------

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

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

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

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

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

[[Page 35578]]

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

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

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

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

    In its recommendation to the Administrator, the STAC wrote:

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

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

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

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

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

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

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

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

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

    Fourth, the STAC noted:

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

    Finally, the STAC stated that

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

[[Page 35579]]

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

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

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

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

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

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

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

[[Page 35580]]

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

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

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

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

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

[[Page 35590]]

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

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

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

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

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

[[Page 35591]]

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

[[Page 35592]]

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

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

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

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

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

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

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

[[Page 35593]]

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

E. Effects of Rulemaking on Federal Agencies

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

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

IV. Summary of Proposed Rule

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

[[Page 35594]]

V. Regulatory Assessment Requirements

A. Executive Order 12866 and Executive Order 13563

    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). E.O. 
13563 emphasizes the importance of quantifying both costs and benefits, 
of reducing costs, of harmonizing rules, and of promoting flexibility.
    This rule has been determined to be a ``significant regulatory 
action,'' under Sec.  3(f) of E.O. 12866. The addition of specific 
types of cancer proposed to be added to the List of WTC-Related Health 
Conditions by this rule is estimated to cost the WTC Health Program 
between $2,124,624 \16\ and $5,019,182 \17\ (see Table 9) for the first 
year (2013). Because a portion of responders and survivors are also 
covered by private health insurance, employer-provided insurance (such 
as FDNY), or Medicare or Medicaid, only a portion of the costs, those 
costs representing the uninsured, are societal costs. All other costs 
to the WTC Health Program are transfers. After the implementation of 
provisions of the Patient Protection and Affordable Care Act (Pub. L. 
111-148) on January 1, 2014, all of the costs to the WTC Health Program 
will be transfers. Transfers from FY 2013 through FY 2016 are expected 
to be between $12,458,535 and $33,308,060 per annum. Accordingly, this 
rule has been reviewed by the Office of Management and Budget. The 
proposed rule would not interfere with State, local, and Tribal 
governments in the exercise of their governmental functions.
---------------------------------------------------------------------------

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

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

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

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

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

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

[[Page 35595]]

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

    \22\ Yabroff KR, Lamont EB, Mariotto A, Warren JL, Topor M, 
Meekins A, Brown ML [2008]. Cost of Care for Elderly Cancer Patients 
in the United States. Journal: J Natl Cancer Inst 100(9):630-41.

                              Table 1--Average Costs of Treatment, Male and Female
                                                    [2011 $]
----------------------------------------------------------------------------------------------------------------
                                                            Initial  (12        Continuing     Last year of life
                        Category                               month)            (annual)           (12 mos.)
----------------------------------------------------------------------------------------------------------------
Head and Neck..........................................            $28,265             $3,136            $47,730
Digestive System.......................................             59,551              2,544             68,242
Respiratory System.....................................             45,493              5,026             65,592
Mesothelium............................................             45,493              5,026             65,592
Skin...................................................              3,938              1,040             25,351
Female Reproductive Organs.............................             66,527              5,023             64,728
Urinary System.........................................             16,926              3,630             40,905
Blood & Lymphoid Tissue................................             33,312              5,782             69,070
Endocrine System.......................................             30,859              3,791             58,623
Soft Tissue Sarcomas...................................             30,859              3,791             58,623
Melanoma...............................................              3,938              1,040             25,351
Breast.................................................             15,136              1,550             37,684
Eye/Orbit..............................................             30,859              3,791             58,623
----------------------------------------------------------------------------------------------------------------
Source: Yabroff KR, Lamont EB, Mariotto A, Warren JL, Topor M, Meekins A, Brown ML [2008]. Cost of Care for
  Elderly Cancer Patients in the United States. Journal: J Natl Cancer Inst 100(9):630-41.

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

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

Incident Cases of Cancer
    HHS estimated the expected number of cases of cancer that would be 
observed in a cohort of responders and survivors followed for cancer 
incidence after September 11, 2001 using U.S. population cancer rates 
for the cancer types proposed to be added to the List of WTC-Related 
Health Conditions under this rulemaking. Demographic characteristics of 
the cohort were assigned since the actual data are not available for 
individuals in the responder and survivor populations who have not yet 
enrolled in the WTC Health Program. Gender and age (at the time of 
exposure) distributions for responders and survivors were assumed to be 
the same as current enrollees in the WTC Health Program. According to 
WTC Health Program data, males comprise 88 percent of the current 
responder enrollees and 50 percent of survivor enrollees. The age 
distribution for current enrollees by gender and responder/survivor 
status is presented in Table 2.

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

[[Page 35596]]

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

    HHS assumed race and ethnic origin distributions for responders and 
survivors according to distributions in the WTC Health Registry cohort: 
\25\ 57 percent non-Hispanic white, 15 percent non-Hispanic black, 21 
percent Hispanic, and 8 percent other race/ethnicity for responders and 
50 percent non-Hispanic white, 17 percent non-Hispanic black, 15 
percent Hispanic, and 18 percent other race/ethnicity for survivors. 
Follow-up for cancer morbidity for each person began on January 1, 2002 
or age 15 years, whichever was later. Age 15 was considered because the 
cancer incidence rate file did not include rates for persons less than 
15 years of age. Follow-up ended on December 31, 2016 or the estimated 
last year of life, whichever was earlier. The estimated last year of 
life was used since not all persons would be expected to remain alive 
at the end of 2016. The estimated last year of life was based on U.S. 
gender, race, age, and year-specific death rates from CDC Wonder (since 
rates are currently available through 2008, the rate from 2008 was 
applied to 2009 and later).\26\ A life-table analysis program, 
LTAS.NET, was used to estimate the expected number of incident cancers 
for cancer types proposed to be added.\27\ HHS calculated cancer 
incidence rates using data through 2006 from the Surveillance 
Epidemiology and End Results (SEER) Program, and estimated rates for 
2007-2016.\28\ The Program applied the resulting gender, race, age, and 
year-specific cancer incidence rates to the estimated person-years at 
risk to estimate the expected number of cancer cases for each cancer 
type starting from year 2002, the first full year following the 
September 11, 2001, terrorist attacks, to 2016, the last year for which 
this Program is authorized.
---------------------------------------------------------------------------

    \25\ Jordan HT, Brackbill RM, Cone JE, Debchoudhury I, Farfel 
MR, Greene CM, Hadler JL, Kennedy J, Li J, Liff J, Stayner L, 
Stellman SD. Mortality Among Survivors of the Sept 11, 2001, Word 
Trade Center Disaster: Results from the World Trade Center Health 
Registry Cohort. Lancet 2011;378:879-887.
    \26\ Centers for Disease Control and Prevention, National Center 
for Health Statistics. Compressed Mortality File 1999-2008. CDC 
WONDER Online Database, compiled from Compressed Mortality File 
1999-2008 Series 20 No. 2N, 2011. Accessed at http://wonder.cdc.gov/cmf-icd10.html 15 February 2012.
    \27\ Schubauer-Berigan MK, Hein MJ, Raudabaugh WM, Ruder AM, 
Silver SR, Spaeth S, Steenland K, Petersen MR, and Waters KM [2011]. 
Update of the NIOSH Life Table Analysis System: A Person-Years 
Analysis program for the Windows Computing Environment. American 
Journal of Industrial Medicine 54:915-924.
    \28\ National Cancer Institute, Surveillance Epidemiology and 
End Results (SEER). 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, HHS used the number of incident cases 
described above for each year starting with 2002, and estimated the 
prevalence of cancer using survival rate statistics for each incident 
cancer group through 2016.\29\
---------------------------------------------------------------------------

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

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

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

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

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

[[Page 35597]]

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

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

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

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

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

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

[[Page 35598]]

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

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

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

[[Page 35599]]

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

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

[[Page 35600]]

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

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

[[Page 35601]]

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

Summary of Costs and Transfers
    Because HHS lacks data to account for either recoupment by health 
insurance or workers' compensation insurance or reduction by Medicare/
Medicaid payments, the estimates offered here are reflective of 
estimated WTC Health Program costs only. This analysis offers an 
assumption about the number of individuals who might enroll in the WTC 
Health Program, and estimates the impact of a low rate of cancer (U.S. 
population average rate), and an increased rate (21 percent greater 
than the U.S. population average) on the number of cases and the 
resulting estimated treatment costs to the WTC Health Program. This 
analysis does not include administrative costs associated with 
certifying additional diagnoses of cancers that are WTC-related health 
conditions that might result from this action. Those costs were 
addressed in the interim final rule that established regulations for 
the WTC Health Program (76 FR 38914, July 1, 2011).
    Costs and transfers of screening have been added to the summary 
estimates. The screening proposed by this rulemaking follows U.S. 
Preventive Services Task Force (USPSTF) guidelines.
    The USPSTF recommends screening for colorectal cancer (cancer of 
the colon and rectum) using fecal occult blood testing (FOBT), 
sigmoidoscopy, or colonoscopy, in adults, beginning at age 50 years and 
continuing until age 75 years.\33\ The costs and transfers include the 
costs of one FOBT for all Program enrollees who are over the age of 50 
in 2013, and for those who will reach 50 years of age in 2014 through 
2016. In the general population, HHS expects there to be 9 percent 
positive tests. In a previous study \34\ of those with positive tests 
who were outside the study university system, 44 percent had a 
colonoscopy, 42 percent had flexible sigmoidoscopy, 11 percent had 
repeat FOBT, and 3 percent were told by their physician that no further 
examination was necessary. HHS applied these rates to the population 
and assigned costs for each test assuming FOBT cost was $7.60, 
sigmoidoscopy was $238, and a colonoscopy was $674.\35\
---------------------------------------------------------------------------

    \33\ United States Preventive Services Task Force (USPSTF) 
[2008]. Screening for Colorectal Cancer. Available at http://www.uspreventiveservicestaskforce.org/uspstf/uspscolo.htm. Accessed 
May 28, 2012.
    \34\ Mandel JS, et. al, Reducing Mortality From Colorectal 
Cancer by Screening for Fecal Occult Blood, NEJM 328(19): 1365-1371 
(1993).
    \35\ Subramanian S, et. al. When Budgets Are Tight, There Are 
Better Options Than Colonoscopies For Colorectal Cancer Screening. 
Health Affairs, September 2010, 29:9, 1734-1740.
     FECA Rates for FOBT, sigmoidoscopy and colonoscopy at non-
facility rates: codes 82270, 45330, and 45378 respectively.
---------------------------------------------------------------------------

    The USPSTF recommends breast cancer screening using biennial 
mammography for women beginning at age 40. HHS assumed that the 
population of responders was 12 percent female and the population of 
survivors was 50 percent female. Based on age distribution information 
available, HHS estimated the number of women eligible for screening 
between 2013 and 2016. For those screened in 2013 HHS predicted repeat 
screening in 2015 and for those screened in 2014 HHS predicted repeat 
screening in 2016. The cost of a mammogram was estimated at $139.32 
based on FECA rates for mammography.\36\
---------------------------------------------------------------------------

    \36\ FECA rates for Mammography for New York; FECA code 77057.
---------------------------------------------------------------------------

    Some responders and survivors enrolled or expected to enroll in the 
WTC Health Program already have or have access to medical insurance 
coverage by private health insurance, employer-provided insurance, 
Medicare, or Medicaid. Therefore, costs to the WTC Health Program can 
be divided between societal costs and transfer payments.
    To describe these societal costs and transfers, the following 
assumptions were used. For the period of coverage between January 1, 
2013 and December 31, 2013, HHS has assumed that 16.3 percent of the 
survivor population will be uninsured, or based on grandfathered 
enrollment of responders, 16,925 are covered by the FDNY health plan, 
while 39,482 are listed as general responders and include construction 
workers, contractors, and others. For this analysis, HHS assumed that 
the non-FDNY general responders and all future responder-enrollees are 
uninsured at the same 16.3 percent rate that HHS applied to the 
survivor population, based on those without insurance coverage in the 
general U.S. population.\37\ Ward et al.\38\ found that access to 
health care services, quality of care received, stage of disease at 
diagnosis, and survival outcomes for cancer patients varied according 
to socioeconomic status and demographic characteristics.
---------------------------------------------------------------------------

    \37\ U.S. Census Bureau [2011]. Current Population Survey. 
http://www.census.gov/cps/data/. Accessed May 26, 2012.
    \38\ Ward E, Halpern M, Schrag N, Cokkinides V, DeSantis C, 
Bandi P, Siegel R, Stewart A, Jemal A [2008]. Association of 
Insurance with Cancer Care Utilization and Outcomes. CA Cancer J 
Clin 58:9-31.
---------------------------------------------------------------------------

    Additionally, after the implementation of provisions of the Patient 
Protection and Affordable Care Act (Pub. L. 111-148) on January 1, 
2014, all of the enrollees and future enrollees can be assumed to have 
or have access to medical insurance coverage other than through the WTC 
Health Program. Therefore, all treatment costs to be paid by the WTC 
Health Program from 2014 through 2016 are considered transfers.
    Table 9 describes the allocation of WTC Health Program costs 
between societal costs and transfer payments based on 55,000 responders 
and 5,000 survivors. Table 10 describes the allocation of WTC Health 
Program costs between societal costs and transfer payments based on 
80,000 responders and 30,000 survivors.

[[Page 35602]]

  Table 9--Breakdown of Estimated Annual WTC Health Program Costs and Transfers, 80,000 & 55,000 Responders and
                                  30,000 and 5,000 survivors, 2013-2016, 2011$
----------------------------------------------------------------------------------------------------------------
 
----------------------------------------------------------------------------------------------------------------
                                         Societal costs for 2013, 2011$
                                       Annualized transfers for 2013-2016,
                                                      2011$
                                     ---------------------------------------------------------------------------
                                      Based on the 16.3 percent of general   Discounted at 7    Discounted at 3
                                        responders and survivors who are         percent            percent
                                            expected to be uninsured
                                     ---------------------------------------------------------------------------
                                                   Cancer rate
                                                   Cancer rate
----------------------------------------------------------------------------------------------------------------
                                         U.S. Average        U.S. + 21%        U.S. Average        U.S. + 21%
55,000 Responders...................         $1,648,706  .................        $10,172,308  .................
5,000 Survivors.....................            271,427  .................          1,572,907  .................
Colorectal and Breast Screening.....            204,491  .................            713,321  .................
----------------------------------------------------------------------------------------------------------------
60,000 Total........................          2,124,624  .................         12,458,535  .................
----------------------------------------------------------------------------------------------------------------
80,000 Responders...................  .................         $2,631,100  .................        $19,912,464
30,000 Survivors....................  .................          1,970,560  .................         12,124,118
Colorectal and Breast Screening.....  .................            417,521  .................          1,271,478
----------------------------------------------------------------------------------------------------------------
110,000 Total.......................  .................          5,019,182  .................         33,308,060
----------------------------------------------------------------------------------------------------------------

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

[[Page 35603]]

personal, quantitative exposure data impedes the definitive 
epidemiologic evidence that exposure to 9/11 agents causes certain 
types of cancer in responder and survivor populations. In addition, 
cancer is generally a long latency set of diseases which in some cases 
may take many years or even decades to manifest clinically. Requiring 
evidence of positive associations from studies of 9/11-exposed 
populations exclusively does not serve the best interests of WTC Health 
Program members.
    By expanding the scope of scientific information reviewed to 
include three complementary methods (including studies in 9/11 exposed 
populations and generally available epidemiologic criteria), the 
Administrator has developed a hierarchy of methods to guide 
consideration of whether to include types of cancers on the List of 
WTC-Related Health Conditions.
Effects on Other Agency Programs
    HHS finds that this rulemaking also has an effect on the VCF \39\ 
administered by DOJ. DOJ administers the VCF under rules promulgated at 
28 CFR part 104. The DOJ regulations define, in 28 CFR 104.2 (f), the 
term ``WTC-related health condition'' to mean ``those health conditions 
identified as WTC-related by Title I of Public Law 111-347 and by 
regulations implementing that Title.'' The preamble to the VCF final 
rule (76 FR 54115) states, ``If the WTC Health Program determines that 
certain forms of cancer should be added to the list of WTC-related 
conditions, the final rule requires the Special Master to add such 
conditions to the list of presumptively covered conditions for the 
Fund.''
---------------------------------------------------------------------------

    \39\ The September 11th Victim Compensation Fund of 2001 (VCF) 
was initially established in 2001 pursuant to Title IV of Public Law 
107-42, 115 Stat. 230 (Air Transportation Safety and System 
Stabilization Act) and was open for claims from December 21, 2001, 
through December 22, 2003. Title II of the Zadroga Act amends and 
reactivates the September 11th Victim Compensation Fund of 2001. 
Public Law 111-347. Administered through DOJ by a Special Master, 
the VCF provides compensation to any individual (or a personal 
representative of a deceased individual) who suffered physical harm 
or was killed as a result of the terrorist-related aircraft crashes 
of September 11, 2001, or the debris removal efforts that took place 
in the immediate aftermath of those crashes.
---------------------------------------------------------------------------

    Under the VCF program, compensation awards are generally calculated 
using three components: Economic loss plus non-economic loss minus 
collateral source payments. To determine economic loss, the Special 
Master considers any prior loss of earnings or other benefits related 
to employment, medical expense loss, replacement services loss, and 
loss of business or employment opportunity. The regulations provide 
presumed non-economic awards for deceased individuals. Because every 
physical injury is unique, the Special Master may determine presumed 
non-economic losses on a case-by-case basis for physically injured 
claimants. The Special Master then subtracts any collateral offsets 
received or eligible to be received. The computation of individual 
compensation due under the fund is based on factors pertinent to each 
individual claimant.
    The statute caps the total amount of funds allocated to the VCF. 
The VCF regulation at 28 CFR 104.51 provides that, ``the total amount 
of Federal funds paid for expenditures including compensation with 
respect to claims filed on or after October 3, 2011, will not exceed 
$2,775,000,000. Furthermore, the total amount of Federal funds expended 
during the period from October 3, 2011, through October 3, 2016, may 
not exceed $875,000,000.''
    To meet these requirements, the Special Master is authorized to 
reduce the amount of compensation due to each claimant by prorating the 
total amount of the compensation award determined for each individual 
claimant. The VCF intends to establish the fraction for proration such 
that all claimants receive some payment related to their claim within 
the overall funding limitation of the program. The Special Master may 
adjust the percentage of the total award that is to be paid to eligible 
claims based on experiential information as well as estimates related 
to potential future claims and availability of funds.
    The amount of compensation that would be awarded to each of the 
living claimants who develop, or the heirs of those who died from, a 
covered type of cancer during the years 2002 through 2016, would be 
determined by individual factors considered under the VCF. Depending on 
the total number of new claims and compensation eligibility, the 
overall impact on the VCF of increasing the number of eligible VCF 
claimants as a result of adding eligible health condition under the WTC 
Health Program may be to reduce the proration fraction that is applied 
to all VCF claimants such that the total cost to the government remains 
unchanged. The additional costs to the VCF due to processing and 
computing the entitlement for the extra claimants eligible as a result 
of having a covered type of cancer, plus the costs of paying newly 
covered claimants their prorated share of the compensation award, would 
result in amounts that will not be available to pay increased shares 
for the claimants with non-cancer conditions.

B. Regulatory Flexibility Act

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

[[Page 35604]]

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

C. Paperwork Reduction Act

    The Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., requires 
an agency to invite public comment on, and to obtain OMB approval of, 
any regulation that requires 10 or more people to report information to 
the agency or to keep certain records. Data collection and 
recordkeeping requirements for the WTC Health Program are approved by 
OMB under ``World Trade Center Health Program Enrollment, Appeals & 
Reimbursement'' (OMB Control No. 0920-0891, exp. December 31, 2014). 
HHS has determined that no changes are needed to the information 
collection request already approved by OMB.

D. Small Business Regulatory Enforcement Fairness Act

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

E. Unfunded Mandates Reform Act of 1995

    Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531 
et seq.) directs agencies to assess the effects of Federal regulatory 
actions on State, local, and Tribal governments, and the private sector 
``other than to the extent that such regulations incorporate 
requirements specifically set forth in law.'' For purposes of the 
Unfunded Mandates Reform Act, this proposed rule does not include any 
Federal mandate that may result in increased annual expenditures in 
excess of $100 million by State, local or Tribal governments in the 
aggregate, or by the private sector. However, the rule may result in an 
increase in the contribution made by New York City for treatment and 
monitoring, as required by Title XXXIII, Sec.  3331(d)(2). For 2012, 
the inflation adjusted threshold is $139 million.

F. Executive Order 12988 (Civil Justice)

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

G. Executive Order 13132 (Federalism)

    HHS has reviewed this proposed rule in accordance with Executive 
Order 13132 regarding federalism, and has determined that it does not 
have ``federalism implications.'' The rule does not ``have substantial 
direct effects on the States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government.''

H. Executive Order 13045 (Protection of Children From Environmental 
Health Risks and Safety Risks)

    In accordance with Executive Order 13045, HHS has evaluated the 
environmental health and safety effects of this proposed rule on 
children. HHS has determined that the rule would have no environmental 
health and safety effect on children, although an eligible child who 
has been diagnosed with a cancer type specified in this rulemaking may 
seek certification of the condition by the Administrator.

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

    In accordance with Executive Order 13211, HHS has evaluated the 
effects of this proposed rule on energy supply, distribution or use, 
and has determined that the rule will not have a significant adverse 
effect.

J. Plain Writing Act of 2010

    Under Public Law 111-274 (October 13, 2010), executive Departments 
and Agencies are required to use plain language in documents that 
explain to the public how to comply with a requirement the Federal 
Government administers or enforces. HHS has attempted to use plain 
language in promulgating the proposed rule consistent with the Federal 
Plain Writing Act guidelines and requests comment from the public 
regarding this requirement.

VI. Proposed Rule

List of Subjects in 42 CFR Part 88

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

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

PART 88--WORLD TRADE CENTER HEALTH PROGRAM

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

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

Sec.  88.1  [Amended]

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

Sec.  88.1  Definitions.

* * * * *
    List of WTC-related health conditions * * *
* * * * *
    (4) Cancers: This list includes those individual cancer types 
specified in Table 1, below, according to the International 
Classification of Diseases, 10th Edition (ICD-10) and International 
Classification of Diseases, 9th Edition (ICD-9).
BILLING CODE P

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    Dated: May 31, 2012.
John Howard,
Administrator, World Trade Center Health Program and Director, National 
Institute for Occupational Safety and Health, Centers for Disease 
Control and Prevention, Department of Health and Human Services.
[FR Doc. 2012-14203 Filed 6-8-12; 4:15 pm]
BILLING CODE C
```