9100 Federal Register / Vol. 79, No. 32 / Tuesday, February 18, 2014 / Rules and Regulations 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Incorporation by 

reference, Intergovernmental relations, 

Nitrogen dioxide, Ozone, Particulate 

matter, Reporting and recordkeeping 

requirements, Volatile organic 

compounds. 

Dated: January 28, 2014. 

Ron Curry, 

Regional Administrator, Region 6. 

40 CFR part 52 is amended as follows: 

PART 52—APPROVAL AND 

PROMULGATION OF 

IMPLEMENTATION PLANS 

■ 1. The authority citation for part 52 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

Subpart GG—New Mexico 

■ 2. In § 52.1620, the second table in 

paragraph (c) entitled, ‘‘EPA Approved 

Albuquerque/Bernalillo County, NM 

Regulations,’’ is amended by revising 

the entries for Part 3 (20.11.3 NMAC), 

Transportation Conformity, and Part 4 

(20.11.4 NMAC), General Conformity to 

read as follows: 

§ 52.1620 Identification of plan. 

* * * * * 

(c) * * * 

* * * * * 

EPA APPROVED ALBUQUERQUE/BERNALILLO COUNTY, NM REGULATIONS

State citation Title/subject 

State approval/effective 

date 

EPA approval date Explanation 

New Mexico Administrative Code (NMAC) Title 20—Environment Protection Chapter 11—Albuquerque/Bernalillo County Air Quality Control 

Board 

*******

Part 3 ( 20.11.3 

NMAC).

Transportation Conformity ............ 11/18/2010; 

10/11/2012 

2/18/2014 [Insert FR page number where document begins].

Part 4 (20.11.4 

NMAC).

General Conformity ....................... 5/24/2011 2/18/2014 [Insert FR page number where document begins].

* * * * * * * 

* * * * * 

[FR Doc. 2014–03434 Filed 2–14–14; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Docket No. CDC–2014–0004; NIOSH–268] 

42 CFR Part 88 

RIN 0920–AA50 

World Trade Center Health Program; 

Amendments to List of WTC-Related 

Health Conditions; Cancer; Revision 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Interim final rule. 

SUMMARY: On September 12, 2012, the 

Administrator of the WTC Health 

Program (Administrator) published a 

final rule in the Federal Register adding 

certain types of cancer to the List of 

World Trade Center (WTC)-Related 

Health Conditions (List) in the WTC 

Health Program regulations; an 

additional final rule was published on 

September 19, 2013 adding prostate 

cancer to the List. Through the process 

of implementing the addition of cancers 

to the List and integrating cancer 

coverage into the WTC Health Program, 

the Administrator has identified the 

need to amend the rule to remove the 

ICD codes and specific cancer sub-sites, 

clarify the definition of ‘‘childhood 

cancers,’’ revise the definition of ‘‘rare 

cancers,’’ and notify stakeholders that 

the Administrator is revising WTC 

Health Program policy related to 

coverage of cancers of the brain and the 

pancreas. No types of cancer covered by 

the WTC Health Program will be 

removed by this action; four types of 

cancer—malignant neoplasms of the 

brain, the cervix uteri, the pancreas, and 

the testis—are newly eligible for 

certification as WTC-related health 

conditions as a result of this action. 

DATES: This interim final rule will be 

effective February 18, 2014. The 

Administrator invites written comments 

from interested parties on this interim 

final rule. Comments must be received 

by April 21, 2014. 

ADDRESSES: Written Comments: You 

may submit comments by any of the 

following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: NIOSH Docket Office, Robert 

A. Taft Laboratories, MS–C34, 4676 

Columbia Parkway, Cincinnati, OH 

45226. 

Instructions: All submissions received 

must include the agency name (Centers 

for Disease Control and Prevention, 

HHS) and docket number (CDC–2014– 

0004; NIOSH–268) or Regulation 

Identifier Number (0920–AA50) for this 

rulemaking. All relevant comments, 

including any personal information 

provided, will be posted without change 

to http://www.regulations.gov. For 

detailed instructions on submitting 

public comments, see the ‘‘Public 

Participation’’ heading of the 

SUPPLEMENTARY INFORMATION section of 

this document. 

Docket: For access to the docket to 

read background documents, go to 

http://www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: Paul 

Middendorf, Senior Health Scientist, 

1600 Clifton Rd. NE., MS: E–20, Atlanta, 

GA 30329; telephone (404) 498–2500 

(this is not a toll-free number); email 

pmiddendorf@cdc.gov. 

SUPPLEMENTARY INFORMATION: 

This rule is organized as follows: 

I. Executive Summary 

A. Purpose of Regulatory Action 

B. Summary of Major Provisions 

C. Costs and Benefits 

II. Public Participation 

III. Background 

A. WTC Health Program Statutory 

Authority 

B. Rulemaking History 

C. Need for Rulemaking 

1. Table 1 

2. Childhood Cancers 

3. Rare Cancers 

4. Cancers of the Brain and the Pancreas 

IV. Rare Cancers 

A. STAC Recommendation 


tkelley on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 79, No. 32 / Tuesday, February 18, 2014 / Rules and Regulations 9101 

1Rare cancers were defined in Table 1 as, ‘‘Any 

type of cancer affecting the [sic] populations 

smaller than 200,000 individuals in the Unites [sic] 

States, i.e., occurring at an incidence rate less than 

0.08 percent of the U.S. population. Rare cancers 

will be determined on a case-by-case basis.’’ 

2WHO (World Health Organization) [1978]. 

International Classification of Diseases, Ninth 

Revision. Geneva: World Health Organization. 

3WHO (World Health Organization) [1997]. 

International Classification of Diseases, Tenth 

Revision. Geneva: World Health Organization. 

4Title XXXIII of the PHS Act is codified at 42 

U.S.C. 300mm to 300mm–61. Those portions of the 

Zadroga Act found in Titles II and III of Public Law 

111–347 do not pertain to the WTC Health Program 

and are codified elsewhere. 

B. WTC Health Program Rare Cancers 

Definition and Numeric Threshold 

Determination 

1. Rare Cancers Numeric Threshold 

2. Application of Rare Cancers Numeric 

Threshold 

V. Cancers of the Brain and the Pancreas 

A. STAC Recommendation 

B. WTC Health Program Determination 

VI. Effects of Rulemaking on Federal 

Agencies 

VII. Issuance of an Interim Final Rule With 

Immediate Effective Date 

VIII. Summary of Interim Final Rule 

IX. Regulatory Assessment Requirements 

A. Executive Order 12866 and Executive 

Order 13563 

B. Regulatory Flexibility Act 

C. Paperwork Reduction Act 

D. Small Business Regulatory Enforcement 

Fairness Act 

E. Unfunded Mandates Reform Act of 1995 

F. Executive Order 12988 (Civil Justice) 

G. Executive Order 13132 (Federalism) 

H. Executive Order 13045 (Protection of 

Children From Environmental Health 

Risks and Safety Risks) 

I. Executive Order 13211 (Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use) 

J. Plain Writing Act of 2010 

I. Executive Summary 

A. Purpose of Regulatory Action 

The purpose of this action is to amend 

regulatory language added to 42 CFR 

88.1 in paragraph (4) of the definition of 

‘‘List of WTC-related health conditions’’ 

by the final rule published in the 

Federal Register on September 12, 2012 

(77 FR 56138) and announce a revision 

to the Administrator’s decision to 

exclude certain types of cancer from 

WTC Health Program coverage. The 

Administrator has found that a detailed 

list of sub-codes unnecessarily 

constrains the WTC Health Program’s 

ability to appropriately identify which 

members’ cancers are eligible for 

certification. The Administrator has also 

identified the need to clarify that 

childhood cancers are cancers that are 

first diagnosed in a person under the age 

of 20 years. The current definition does 

not clearly indicate that the 

Administrator has always intended to 

certify cases of cancer in WTC Program 

members who were under the age of 20 

when they were first diagnosed, even 

though they may be over the age of 20 

when they enter the WTC Health 

Program. Finally, the Administrator has 

also identified problems with the 

definition of ‘‘rare cancers’’ established 

in § 88.1.1 In application, the definition 

has proven confusing and imprecise, 

reflecting neither the intent of the 

Administrator nor the concern of the 

WTC Health Program Scientific/

Technical Advisory Committee (STAC) 

that led the STAC to recommend adding 

such a category of cancers. 

In addition, the Administrator has 

found it appropriate to reconsider and 

reverse the WTC Health Program policy 

to deny certification of cases of 

malignant neoplasms of the brain (brain 

cancer) and the pancreas (pancreatic 

cancer) as WTC-Related Health 

Conditions. With this rulemaking, these 

two types of cancer become eligible for 

certification and Program coverage. 

B. Summary of Major Provisions 

The Administrator is striking the 

regulatory language indicating that 

covered cancer types would be specified 

by medical diagnostic codes (ICD–9 2

and ICD–10 3). The rule is further 

amended to remove Table 1 in its 

entirety and to replace it with the 

narrative list of 24 broadly specified 

cancer types by body organ or region 

identified by the September 2012 final 

rule and in a subsequent final 

rulemaking published September 19, 

2013 adding prostate cancer to the List. 

Although the codes and subcodes have 

been removed, all of the specifically 

identified types of cancers that were 

included in Table 1 are still covered by 

the Program. 

The Administrator is amending the 

definition of ‘‘childhood cancers’’ to 

clarify that childhood cancers are any 

type of cancer diagnosed in a person 

less than 20 years of age. 

The Administrator is amending the 

definition of ‘‘rare cancers’’ to revise the 

numeric threshold which determines 

those cancers which are considered rare. 

This amendment will result in two 

additional types of cancer meeting the 

definition of ‘‘rare cancers’’ and being 

eligible for coverage—malignant 

neoplasm of the cervix uteri (invasive 

cervical cancer) and malignant 

neoplasm of the testis (testicular 

cancer). (See discussion in Section 

IV.B., below.) 

The Administrator also announces 

that he has reviewed and reversed the 

policy of considering cancers of the 

brain and the pancreas ineligible for 

WTC Health Program coverage. With 

this rule, the Administrator establishes 

that these two types of cancer will now 

be considered eligible for coverage as 

rare cancers. 

C. Costs and Benefits 

The total costs and benefits resulting 

from this regulatory action are due to 

brain cancer, invasive cervical cancer, 

pancreatic cancer, and testicular cancer 

being eligible for coverage by the 

Program as ‘‘rare cancers.’’ The 

Administrator estimates the costs of 

medical treatment for the four cancers 

now considered eligible under the 

definition of rare cancers, as well as 

screening costs associated with invasive 

cervical cancer, to be between 

$2,287,933 and $4,933,280 annually for 

FY 2014 through FY 2016. 

II. Public Participation 

Interested persons or organizations 

are invited to participate in this 

rulemaking by submitting written views, 

opinions, recommendations, and/or 

data. Comments are invited on any topic 

related to this interim final rule. In 

addition, the Administrator invites 

comments specifically on the following 

question related to this rulemaking: 

1. What incidence per 100,000 

persons per year in the United States 

(‘‘incidence rate’’) should be used by the 

WTC Health Program as the threshold 

for determining whether a type of 

cancer is rare in relation to the 

incidence rates for all types of cancer in 

the U.S. population? Please provide a 

justification for the suggested incidence 

rate. 

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. The 

Administrator will consider the 

comments submitted and may revise the 

final rule as appropriate. 

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 4 establishing the WTC 

Health Program within the Department 

of Health and Human Services (HHS). 

The WTC Health Program provides 

medical monitoring and treatment 


tkelley on DSK3SPTVN1PROD with RULES
9102 Federal Register / Vol. 79, No. 32 / Tuesday, February 18, 2014 / Rules and Regulations 

5PHS Act, sec. 3312(a)(6)(B)(i); 42 CFR 

88.17(a)(2)(i). 6 77 FR 35574, 35576 (June 13, 2012). 

7 Including a categorical definition of childhood 

cancers, which includes any type of cancer 

diagnosed in an individual under the age of 20 

years. 8On October 12, 2012, the Administrator 

published a Federal Register notice to correct errors 

in Table 1 of the final rule (the list of cancers 

covered by the Program) (77 FR 62167). 

9Rare cancers were defined in Table 1 as, ‘‘Any 

type of cancer affecting the [sic] populations 

smaller than 200,000 individuals in the Unites 

States, i.e., occurring at an incidence rate less than 

0.08 percent of the U.S. population. Rare cancers 

will be determined on a case-by-case basis.’’ 

10Public Law 107–280, sec. 2(a)(1); 42 U.S.C. 

283h(c). 

benefits to eligible firefighters and 

related personnel, law enforcement 

officers, and rescue, recovery, and 

cleanup workers (responders) who 

responded to the September 11, 2001, 

terrorist attacks in New York City, at the 

Pentagon, and in Shanksville, 

Pennsylvania, and to eligible persons 

(survivors) who were present in the dust 

or dust cloud on September 11, 2001 or 

who worked, resided, or attended 

school, childcare, or adult daycare in 

the New York City disaster area. 

All references to the Administrator of 

the WTC Health Program in this rule 

mean the National Institute for 

Occupational Safety and Health 

(NIOSH) Director or his or her designee. 

Section 3312(a)(6) of the PHS Act 

requires the Administrator to conduct 

rulemaking to propose the addition of a 

health condition to the List of WTCRelated Health Conditions (List) 

codified in 42 CFR 88.1. 

B. Rulemaking History 

On September 7, 2011, the 

Administrator received a written 

petition to add a health condition to the 

List of WTC-Related Health Conditions 

(Petition 001). Petition 001 requested 

that the Administrator ‘‘consider adding 

coverage for cancer’’ to the List of WTCRelated Health Conditions specified in 

§ 88.1. On October 5, 2011, the 

Administrator formally exercised his 

option to request a recommendation 

from the STAC regarding the petition.5

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.’’ 6 In 

response, the STAC submitted its 

recommendation on April 2, 2012. After 

considering the STAC’s 

recommendation, the Administrator 

issued a notice of proposed rulemaking 

on June 13, 2012 (77 FR 35574). On 

September 12, 2012, the Administrator 

published a final rule in the Federal 

Register adding certain types of cancer 7

to the List of WTC-Related Health 

Conditions in 42 CFR 88.1 (77 FR 

56138).8 On May 2, 2013, the 

Administrator received a written 

petition to add prostate cancer to the 

List (Petition 002). After considering the 

petition, the Administrator published a 

notice of proposed rulemaking on July 

2, 2013 (78 FR 39670) and a final rule 

on September 19, 2013 (78 FR 57505) 

adding prostate cancer to the List. 

C. Need for Rulemaking 

1. Table 1 

The final rule adding certain types of 

cancer to the List became effective on 

October 12, 2012 (the addition of 

prostate cancer became effective 

October 21, 2013). Since that time, the 

WTC Health Program has worked to 

develop guidelines and procedures to 

incorporate those types of cancers into 

existing Program health condition 

certification practices. However, during 

the first year of implementation, the 

Program discovered that the complex 

process of translating the ICD–9 codes to 

ICD–10 codes has resulted in confusion 

among Program medical staff and 

Clinical Centers of Excellence (CCEs) 

and Nationwide Provider Network 

physicians. The Administrator finds 

that the detailed list of ICD codes in 

Table 1, including sub-codes, is 

inappropriately restrictive and often 

results in coding errors. For instance, 

CCE physicians have at times submitted 

requests for certification using a 

different ICD code for the listed cancer 

type than the Administrator used in 

Table 1. ICD codes are highly nuanced 

and, for some cancers, choosing the 

precise code may be a matter of 

professional judgment on the part of the 

physician making a health condition 

determination. When a physician 

submits an ICD code that differs from 

codes included in Table 1, the 

Administrator must then determine 

whether the specific code chosen by the 

physician references a type of cancer 

that was actually intended to be covered 

by the Program or could be otherwise 

correctly characterized. In some 

instances, the determining physician 

used a different or more-specific 

subcode than was included in the List; 

however, after review, the 

Administrator agreed that the type of 

cancer submitted by the physician fits 

within the intent of the final rule on 

cancer. A detailed list of sub-codes is 

unnecessary, confusing to providers, 

and limits the WTC Health Program’s 

ability to appropriately identify which 

members’ cancers are eligible for 

certification, therefore, the 

Administrator is replacing Table 1 with 

a narrative list of cancer categories. 

2. Childhood Cancers 

The Administrator has also identified 

the need to clarify that childhood 

cancers are cancers that are first 

diagnosed in a person under the age of 

20 years. The current definition does 

not clearly indicate that the 

Administrator has always intended to 

certify cases of cancer in WTC Health 

Program members who were under the 

age of 20 when they were first 

diagnosed, even though they may be 

over the age of 20 when they enter the 

WTC Health Program. The existing 

language could be interpreted to mean 

that only a WTC Health Program 

member under the age of 20 years can 

be certified for treatment of a WTCrelated childhood cancer. The revised 

language clarifies that a childhood 

cancer is defined based on age at 

diagnosis rather than the current age of 

the WTC Health Program member. 

3. Rare Cancers 

In addition to the detailed list of ICD 

codes, the Program has also identified 

problems with the definition of ‘‘rare 

cancers’’ established in § 88.1.9 In 

application, the definition has proven 

confusing and imprecise, reflecting 

neither the intent of the Administrator 

nor the STAC’s concern regarding 

difficulties identifying associations 

between exposure and some cancers in 

epidemiologic studies. 

The Administrator has identified 

several problems with the definition of 

rare cancers for the purpose of 

identifying such conditions for WTC 

Health Program coverage as specified in 

42 CFR 88.1. First, the original 

definition was derived from the Rare 

Diseases Act of 2002, which states that, 

‘‘[r]are diseases and disorders are those 

which affect small patient populations, 

typically populations smaller than 

200,000 individuals in the United 

States.’’10 The Rare Diseases Act 

addresses the rarity of disease as 

considered against all possible types of 

diseases, which is different than the 

Administrator’s intent to define the 

rarity of a type of cancer as considered 

against all types of cancer only. 

Second, the Rare Diseases Act 

establishes the threshold for the number 

of cases qualifying a disease as rare 

using ‘‘prevalence’’ (i.e., the number of 

persons in the United States living with 

a particular disease) instead of 


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Federal Register / Vol. 79, No. 32 / Tuesday, February 18, 2014 / Rules and Regulations 9103 

11 77 FR 56138, 56147 (September 12, 2012). 

12The STAC premised its recommendation on 

evidence from four main sources: carcinogens 

present at the New York City attack site with 

limited or sufficient evidence of carcinogenicity in 

humans based on the International Agency for 

Research on Cancer (IARC) Monographs on the 

Evaluation of Carcinogenic Risks to Humans; 

cancers arising from regions of the respiratory and 

digestive tracts where inflammatory conditions 

have been documented; cancers for which 

epidemiologic studies have found some evidence of 

increased risk in WTC responder and survivor 

populations; and 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. The 

STAC evaluated the only peer-reviewed study 

available at the time of its deliberations, an 

epidemiologic study of Fire Department of New 

York (FDNY) firefighters conducted by Rachel ZeigOwens and colleagues, which was published in The 

Lancet in September 2011. [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. The 

Lancet. 378(9794):898–905.] This was also the only 

study available to the Administrator at the time of 

the Petition 001 rulemaking in June and September, 

2012. 

13STAC (World Trade Center Health Program 

Scientific/Technical Advisory Committee) [2012]. 

Letter from Elizabeth Ward, Chair, to John Howard 

MD, Administrator at 1–2. NIOSH Docket 257. 

http://www.cdc.gov/niosh/docket/archive/

docket257.html. 

14 Id. at 25. 

15STAC (World Trade Center Health Program 

Scientific/Technical Advisory Committee) [2012]. 

Letter from Elizabeth Ward, Chair to John Howard, 

MD, Administrator, at 25. This letter is included in 

NIOSH Docket 257, http://www.cdc.gov/niosh/

docket/archive/docket257.html. 

16STAC (World Trade Center Health Program 

Scientific/Technical Advisory Committee) [2012]. 

Letter from Elizabeth Ward, Chair to John Howard, 

MD, Administrator, at 6. This letter is included in 

NIOSH Docket 257, http://www.cdc.gov/niosh/

docket/archive/docket257.html. 

‘‘incidence’’ (i.e., the number of persons 

in the United States that acquire a 

particular disease over a given time 

period). Because life expectancy varies 

greatly across cancer types, some 

cancers occur infrequently but have a 

high survival rate and therefore a high 

prevalence. Similarly, cancers that 

occur more frequently but have a high 

mortality rate have a low prevalence. As 

a result, the prevalence of a type of 

cancer varies substantially depending 

on the life expectancy associated with 

the cancer type. Therefore, the 

Administrator finds that incidence is a 

more useful and appropriate indicator to 

select a rarity threshold for cancer. 

Third, the ‘‘case-by-case basis’’ text is 

misleading. There is no case-specific 

approach to ‘‘determine’’ which cancers 

would qualify as rare cancers. Rare 

cancers will be determined based on 

their incidence as specified in this rule. 

4. Cancers of the Brain and the Pancreas 

In the preamble to the September 12, 

2012 final rule, the Administrator 

concurred with the STAC’s decision to 

not recommend malignant neoplasms of 

the brain and the pancreas for inclusion 

on the List of WTC-Related Health 

Conditions (77 FR 56138, 56147), 

indicating that no compelling evidence 

was found to support their inclusion: 

The issue of whether to recommend the 

addition of cancers of the * * * brain and 

pancreas to the List of WTC-Related Health 

Conditions was considered and discussed by 

the STAC in the open meeting on March 28, 

2012. In those discussions, the STAC 

considered the available evidence for 

recommending the addition of cancers of the 

* * * brain and pancreas, including the 

epidemiologic evidence and the NTP [NIH’s 

National Toxicology Program] and IARC 

reviews. Following its deliberation on the 

matter, the STAC voted not to include * * * 

brain or pancreatic cancer in its 

recommendation. [See STAC (World Trade 

Center Health Program Scientific/Technical 

Advisory Committee) Letter from Elizabeth 

Ward, Chair, to John Howard, MD, 

Administrator [2012].] The Administrator 

concurs with the decision of the STAC and 

is not adding these cancers to the List of 

WTC-Related Health Conditions at this time. 

The addition of these cancers may be 

reconsidered if additional information on the 

association of 9/11 exposures and those 

cancer outcomes becomes available.11

As a result of that determination, the 

WTC Health Program denied 

certification of cancers of the brain and 

the pancreas, even though they were 

found to meet the numeric threshold in 

the definition of rare cancers. After 

review, the Administrator has 

reconsidered that decision and 

determined, for the reasons discussed 

below, that cancers of the brain and the 

pancreas will be considered eligible for 

certification as rare cancers. With this 

rulemaking, a WTC Health Program 

member whose 9/11 exposure is found 

substantially likely to be a significant 

factor in aggravating, contributing to, or 

causing the individual’s brain and/or 

pancreatic cancer, will be certified for 

WTC Health Program treatment services. 

The WTC Health Program will review 

and reassess cases of brain and 

pancreatic cancer that were denied 

certification prior to this rulemaking. 

IV. Rare Cancers 

A. STAC Recommendation 

As noted above, the Administrator 

asked the STAC to deliberate and 

develop recommendations on a petition 

to add cancers to the List of WTCRelated Health Conditions. The STAC 

met on three occasions between 

November 2011 and March 2012, and 

offered its final recommendation to the 

Administrator on April 2, 2012.12 The 

STAC expressed a sense that 

insufficient exposure data from the 

WTC terrorist attack site limited the 

Committee’s ability to identify specific 

cancers definitively linked to the 

terrorist attacks.13 The STAC further 

noted the difficulty of detecting 

excesses of rare cancers in 

epidemiologic studies, concluding that 

rare cancers should be covered on a 

precautionary basis.14 As the 

Administrator understands the STAC’s 

basis for recommending inclusion of a 

rare cancers category, the STAC 

intended for the WTC Health Program to 

establish a category of types of cancers 

that are sufficiently rare that such 

cancers are difficult to evaluate in 

epidemiologic studies in general, and 

9/11 cohorts in particular. 

In its April 2, 2012 letter to the 

Administrator, the STAC formally 

recommended that the Administrator 

add rare cancers to the List of WTC 

Related Health Conditions. According to 

the STAC: 

Excesses in rare cancers are difficult to 

detect in epidemiologic studies. Even large 

studies may have very low numbers of 

expected cases of rare cancers, and thus very 

low statistical power to detect any but very 

large effects. In addition, most cancer studies 

analyze data by organ site, and not by site 

and histology. This can result in inability to 

detect rare site and histology combinations, 

such as angiosarcoma of the liver, associated 

with vinyl chloride monomer exposure, and 

small cell carcinoma of the lung, associated 

with bischloromethyl ether. Cancers can also 

be defined as rare based on the patient’s 

gender (male breast cancer), age (prostate 

cancer in men under 40) or race (melanoma 

in African Americans). Since customary 

study methods are unlikely to identify 

increased risks for rare cancers among WTCexposed populations unless they occur in 

sizable clusters. Nonetheless, given the 

sizable number of carcinogens (and related 

cancer sites) present in WTC smoke and dust, 

it is reasonable to consider the possibility 

that an increased risk of specific rare cancers 

may occur or that the incidence of common 

cancers would be increased at younger ages 

in WTC-exposed populations. One approach 

that has been used is to consider rare cancers 

as cancers with age-adjusted incidence rates 

less than 15 per 100,000, which would result 

in defining 25% of all adult cancers in the 

US as rare. Additional definitions—10 cases 

per million per year, or 1 case per million per 

year—have also been examined.15 [citations 

omitted] 

Further, the STAC specifically 

referenced an incidence rate of less than 

15 cases per 100,000 population to 

characterize the cancer rate among 

children as rare.16 Based on the 

reference to an incidence rate of 15 

cases per 100,000 persons per year in 

the United States, the Administrator 


tkelley on DSK3SPTVN1PROD with RULES
9104 Federal Register / Vol. 79, No. 32 / Tuesday, February 18, 2014 / Rules and Regulations 

17 77 FR 56138, 56143. 

18 77 FR 35574, 35592 (June 13, 2012). 

19 International Rare Cancers Initiative. http://

www.irci.info/abouttheinitiative/. 

20European Society for Medical Oncology. 

Improving Rare Cancer Care in Europe; 

Recommendation on Stakeholder Actions and 

Public Policies. http://www.rarecancerseurope.org/

IMG/pdf/ESMO_Rare_Cancers_

RECOMMENDATIONS_FINAL.pdf. 

21RARECARE. http://www.rarecare.eu/

rarecancers/rarecancers.asp. 

22 Greenlee RT, Goodman MT, Lynch CF, Platz 

CE, Havener LA, Howe HL [2010]. The Occurrence 

of Rare Cancers in U.S. Adults, 1995–2004. Public 

Health Reports 125:28–43. 

23NCI Epidemiology and Genomics Research 

Program. Synergizing Epidemiologic Research on 

Rare Cancers, May 10–11, 2007, Bethesda, MD. 

http://epi.grants.cancer.gov/Synergizing/. 

24 Id. 

25An age-adjusted incidence rate is a weighted 

average of the age-specific rates, where weighted in 

proportion to the number of individuals in the 

corresponding age groups of a standard population. 

The potential confounding effect of age is reduced 

when comparing age-adjusted rates computed using 

the same standard population. 

26Copeland G, Lake A, Firth R, Wohler B, Wu XC, 

Stroup A, Russell C, Boyuk K, Schymura M, 

Hofferkamp J, Kohler B (eds) [2012]. Cancer in 

North America: 2005–2009. Volume One: Combined 

Cancer Incidence for the United States, Canada and 

North America. Springfield, IL: North American 

Association of Central Cancer Registries, Inc. 27Copeland G, Lake A, Firth R, Wohler B, Wu XC, 

Stroup A, Russell C, Boyuk K, Schymura M, 

Hofferkamp J, Kohler B (eds) [2012]. Cancer in 

North America: 2005–2009. Volume One: Combined 

Cancer Incidence for the United States, Canada and 

North America. Springfield, IL: North American 

Association of Central Cancer Registries, Inc. 28 Id. 

concludes that the STAC sought to 

identify types of cancer that are rare 

relative to other types of cancer rather 

than identifying cancers that are rare 

diseases compared to the universe of all 

diseases. 

B. WTC Health Program Rare Cancers 

Definition and Numeric Threshold 

Determination 

1. Rare Cancers Numeric Threshold 

In the preamble to the September 

2012 final rule, the Administrator 

developed a four-part methodology for 

evaluating whether to add a type of 

cancer to the List.17 The definition of 

‘‘rare cancers’’ was established under 

Method 4, which requires that the STAC 

provide a reasonable basis for the 

inclusion of a type or category of cancer. 

The Administrator found the STAC’s 

recommendation to develop a 

categorical definition of rare cancers to 

be reasonable, and at that time thought 

it appropriate to establish a numeric 

threshold derived from the Rare 

Diseases Act of 2002.18 However, in 

hindsight, the definition of rare cancers 

created in the September 2012 WTC 

Health Program final rule established a 

numeric threshold that reflected neither 

the Administrator’s nor the STAC’s 

intent. 

In order to revise the definition of 

‘‘rare cancers’’ and develop a threshold 

better suited to WTC Health Program 

purposes, the Administrator 

reconsidered the STAC’s 

recommendation, and evaluated the 

incidence rates used by research 

organizations in the United States and 

Europe, including the North American 

Association of Central Cancer Registries 

(NAACCR), the National Institutes of 

Health (NIH), the International Rare 

Cancers Initiative (IRCI), the European 

Society for Medical Oncology (ESMO), 

and RARECARE. 

There is no single, universally agreedupon, quantitative definition of ‘‘rare 

cancers.’’ A rarity threshold is a matter 

on which informed experts differ; 

established rarity thresholds also 

depend on the purpose for which the 

definition is applied. The different 

thresholds used by the various 

organizations were developed to 

stimulate epidemiologic studies and 

clinical research on rare cancer 

therapeutics; the Administrator was 

unable to identify any incidence rate 

used by any other organizations for 

purposes similar to the WTC Health 

Program. The European organizations 

IRCI, ESMO, and RARECARE use lower 

incidence thresholds for rare cancers 

than do researchers in the United States: 

IRCI uses a threshold of less than or 

equal to 2 cases per 100,000 persons per 

year; 19 ESMO uses a threshold of less 

than or equal to 5 cases per 100,000 

persons per year; 20 and RARECARE 

uses a threshold of less than or equal to 

6 cases per 100,000 persons per year.21

By contrast, the incidence rate 

employed by NAACCR is less than 15 

cases per 100,000 persons per year.22

This rate of less than 15 cases per 

100,000 persons per year is also used by 

NIH’s Office of Rare Diseases (ORD) and 

the National Cancer Institute’s 

Epidemiology and Genomics Research 

Program (EGRP).23 During a May 2007 

ORD/EGRP workshop, ‘‘Synergizing 

Epidemiologic Research on Rare 

Cancers,’’ meeting participants noted: 

[r]are cancers were defined as those cancers 

for which the incidence rate is less than 15 

cases per 100,000 population or fewer than 

40,000 new cases per year in the United 

States. Although these numbers are relatively 

small, all rare cancers combined account for 

27 percent of cancers diagnosed each year 

and 25 percent of cancer-related deaths, and 

the morbidity and mortality that they cause 

are increasing.24

The Administrator has determined 

that the incidence rate used by U.S. 

researchers—less than 15 cases per 

100,000 persons per year in the United 

States—is most representative of his 

intent and that of the STAC. The 

Administrator has further determined 

that, because incidence rates change 

from year-to-year, rare cancers will be 

identified using average annual data 

from the 2005–2009 period which has 

been age-adjusted 25 to the U.S. 

population in 2000.26 In other words, 

the Administrator will identify each rare 

cancer type based on its average 

incidence rate during the years 2005– 

2009; therefore, for each rare cancer 

type, the incidence rate is static and will 

not be adjusted to reflect current 

incidence rates. Accordingly, the 

threshold incidence rate for rare cancers 

will be less than 15 cases per 100,000 

persons per year in the United States. 

2. Application of Rare Cancers Numeric 

Threshold 

All types of cancer that are not listed 

in 42 CFR 88.1 and that meet the 

threshold of less than of 15 cases per 

100,000 persons per year (based on ageadjusted 2005–2009 average annual 

data) 27 will be considered rare cancers 

and eligible for certification by the 

Program; members whose cancers are 

certified by the WTC Health Program 

will receive medical treatment and 

services. 

The revised numeric threshold in the 

definition of rare cancers will result in 

two types of cancer becoming newly 

eligible for consideration as rare 

cancers. Under the former numeric 

threshold in the definition of rare 

cancers (prevalence of fewer than 

200,000 persons), malignant neoplasms 

of the cervix uteri (invasive cervical 

cancer) and the testis (testicular cancer) 

were not eligible for coverage because 

their respective prevalence estimates are 

greater than the threshold of 200,000 

persons in the United States with these 

conditions. Both invasive cervical 

cancer and testicular cancer, however, 

will be considered rare cancers under 

the new definition because their 

incidence rates are less than 15 cases 

per 100,000 persons per year in the 

United States based on age-adjusted 

2005–2009 average annual data.28

Moreover, all types of cancer which are 

considered rare under the former 

prevalence-based definition based on 

the Rare Diseases Act definition are also 

considered rare under the new 

incidence-based definition. 

V. Cancers of the Brain and the 

Pancreas 

A. STAC Recommendation 

During a meeting held on March 28, 

2012, STAC members discussed 


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Federal Register / Vol. 79, No. 32 / Tuesday, February 18, 2014 / Rules and Regulations 9105 

29STAC (World Trade Center Health Program 

Scientific/Technical Advisory Committee) March 

28, 2012 meeting transcript at 102. NIOSH Docket 

248. http://www.cdc.gov/niosh/docket/archive/

docket248.html. 

30 77 FR 56138 (September 12, 2012). 

31 Id. at 56144 (September 12, 2012). 

32Brain and pancreatic cancers each meet both 

the previous prevalence-based numeric threshold 

and the new incidence-based numeric threshold 

established in this interim final rule to be 

considered rare within the WTC Health Program. 

33STAC (World Trade Center Health Program 

Scientific/Technical Advisory Committee) February 

15, 2012 meeting transcript at 160. NIOSH Docket 

248. http://www.cdc.gov/niosh/docket/archive/

docket248.html. 

34STAC (World Trade Center Health Program 

Scientific/Technical Advisory Committee) March 

28, 2012 meeting transcript at 45. NIOSH Docket 

248. http://www.cdc.gov/niosh/docket/archive/

docket248.html. 

35Anntila A, Pukkala E, Sallmen M, Hernberg S, 

Hemminki K [1995]. Cancer incidence among 

Finnish workers exposed to halogenated 

hydrocarbons. JOEM 37:797–806; Blair A, Grauman 

Continued 

evidence of associations between 9/11 

exposures and cancers of the brain and 

the pancreas, and voted to not 

recommend cancers of the brain or the 

pancreas for inclusion as specificallyidentified cancers on the List of WTCRelated Health Conditions. The 

Committee Chair acknowledged that 

coverage of brain cancer as a rare cancer 

would depend on the categorical 

definition of rare cancer adopted by the 

Administrator; however, the matter of 

whether brain and pancreatic cancers 

should be eligible for consideration as 

‘‘rare cancers’’ was not brought to a 

formal vote.29 The Administrator 

understands that the STAC was 

distinguishing between the standard for 

a specific cancer type to be named to the 

List, and the relatively lower standard 

for a cancer type to fall under the 

definition of rare cancers, which is 

predicated on the condition that those 

cancers occur so infrequently that 

epidemiologic study would be difficult 

and usually inconclusive. 

B. WTC Health Program Determination 

When applying the Administrator’s 

four-part methodology established in 

the September 12, 2012 final rule, 

neither cancers of the brain nor the 

pancreas were found to satisfy any of 

the four methods.30 Additionally, 

although the STAC voted specifically 

not to recommend adding malignant 

neoplasms of either the brain or the 

pancreas to the List of WTC-Related 

Health Conditions, the STAC did 

recommend that the Administrator 

establish a definition of rare cancers (as 

discussed above, rare cancers were 

added to the List using Method 4, which 

requires that the STAC provide a 

reasonable basis for inclusion).31

Considering the numeric thresholds in 

both the former and revised definitions 

of rare cancers, malignant neoplasms of 

both the brain and the pancreas meet 

the definition of rare cancers. As 

discussed below, after reconsideration 

of the STAC recommendation and reevaluation of the available scientific 

evidence, the Administrator finds it 

appropriate to revise his prior decision 

to exclude cancers of the brain and the 

pancreas from consideration under the 

rare cancers category and allow these 

two cancers to be recognized as ‘‘rare,’’ 

for the purposes of the WTC Health 

Program, and therefore eligible for 

certification. 

The rationale provided by the STAC 

for the inclusion of rare cancers as a 

category on the List was that there is 

large uncertainty in associating a rare 

cancer to a specific exposure. Most rare 

cancers have not been adequately 

investigated in epidemiologic studies 

and the relatively small number of cases 

of such cancers may preclude 

epidemiologic study in the future. 

Moreover, future epidemiologic study of 

the small number of expected cancer 

cases in the 9/11-exposed population 

would be of little help in determining 

an association between 9/11 exposures 

and most types of cancer. Although 

malignant neoplasms of the brain and 

the pancreas qualify as rare cancers 

under various numeric thresholds,32 the 

Administrator determined, pursuant to 

the September 2012 final rulemaking, 

that neither type of cancer would be 

considered a rare cancer within the 

WTC Health Program. That 

determination was premised on the 

availability of numerous published 

studies which did not support an 

association between brain and 

pancreatic cancers and environmental 

agents, including certain agents 

identified in 9/11 exposure assessment 

studies. In the September 2012 final 

rule, the Administrator distinguished 

malignant neoplasms of the brain and 

the pancreas from other rare cancers for 

which evidence of causation by 

environmental or occupational exposure 

is lacking and for which there is little 

likelihood that statistically significant 

evidence of association with 9/11 

exposures can be obtained through 

epidemiologic studies. Other rare 

cancers were considered WTC-related 

health conditions because limitations in 

the available information did not allow 

their relationships to the September 11, 

2001, terrorist attacks to be adequately 

studied in the published epidemiologic 

studies and are not likely to be 

adequately studied in the near future. 

At the time of the September 2012 

final rulemaking, in accordance with the 

STAC’s stated basis for recommending 

the inclusion of a rare cancers category 

(see prior discussion, Section IV.A.), the 

Administrator had interpreted the 

presence of many studies addressing 

brain and pancreatic cancer as an 

indication that they could be studied, 

and that associations would be 

identified if present; he originally 

determined that those studies indicate 

that neither cancers of the brain nor the 

pancreas are associated with the 

exposures experienced by WTC 

responders and survivors, and therefore 

they could not be considered WTCrelated. 

In the process of revising the 

definition of rare cancers, the 

Administrator re-visited the STAC’s 

rationale for including the category of 

rare cancers. During its March 2012 

meeting, the STAC considered the 

exposure data collected in the days 

following the September 11, 2001, 

terrorist attacks, and found it extremely 

limited. STAC members acknowledged 

the difficulties in attempting to identify 

associations between 9/11 exposures 

and specific cancer types. This 

sentiment was clearly expressed by the 

STAC Chair, who stated, ‘‘we know 

something but we don’t know 

everything’’ with regard to 9/11 

exposures.33 Following his review of the 

STAC’s findings, the Administrator has 

reconsidered his previous 

determination. He concurs with 

concerns expressed by the STAC, 

including one STAC member’s 

recognition that for many types of 

cancer, such as brain cancer, there are 

difficulties in identifying associations 

with environmental and occupational 

exposures.34 Upon further reflection, 

the Administrator finds it appropriate to 

take a more cautious approach when 

excluding rare cancers from WTC 

Health Program coverage. 

The Administrator now finds that 

while brain cancer or pancreatic cancer 

may be evaluated in a number of 

epidemiologic studies, the limitations of 

those studies are substantial, leading the 

Administrator to conclude that the 

uncertainties surrounding the causes of 

brain and pancreatic cancers are not 

unlike the uncertainties surrounding 

other rare cancers. The Administrator 

reviewed epidemiologic studies of brain 

and pancreatic cancers involving some 

of the carcinogens involved in 9/11 

exposures and identified five significant 

study limitations: (1) The low frequency 

of and difficulty in diagnosing cancers 

of the brain and pancreas; 35 (2) the 


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9106 Federal Register / Vol. 79, No. 32 / Tuesday, February 18, 2014 / Rules and Regulations 

DJ, Lubin JH, Fraumeni JF [1983]. Lung cancer and 

other causes of death among licensed pesticide 

applicators. JNCI 71:31–37; Davis JR, Brownson, 

Garcia, R, Bentz BJ, Turner A [1993]. Family 

pesticide use and childhood brain cancer. Arch 

Environ Contam Toxicol 24:87–92; Garabrant DH, 

Held J, Langholz B, Bernstein L [1988]. Mortality of 

aircraft manufacturing workers in Southern 

California. Am J Ind Med 13:683–693; IARC 

(International Agency for Research on Cancer) 

[2009]. IARC monographs on the evaluation of 

carcinogenic risks to humans. Vol 100 Part C: 

Arsenic, metals, fibres and dusts. Lyon, France; Li 

J, Cone JE, Kahn AR, Brackbill RM, Farfel MR, 

Greene CM, Hadler JL, Stayner LT, Stellman ST 

[2012]. Association between World Trade Center 

exposure and excess cancer risk. JAMA 308:2479– 

2488; Pesatori AC, Sontag JM, Lubin JH, Consonni 

D, Blair A [1994]. Cohort mortality and nested casecontrol study of lung cancer among structural pest 

control workers in Florida (United States). Cancer 

Cause Control 5:310–318; Spirtas R, Steward PA, 

Lee JS, Marano DE, Forbes, CD, Grauman DJ, 

Pettigrew HM, Blair A, Hoover RN, Cohen JL [1991]. 

Retrospective cohort mortality study of workers at 

an aircraft maintenance facility. I Epidemiologic 

results. Br J Ind Med 48:515–530; Stroup NE., Blair 

A, Erikson GE [1986]. Brain cancer and other causes 

of death in anatomists. JNCI 77:1217–1224; ZeigOwens R, Webber MP, Hall CB, Schwartz T, Javer 

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. The Lancet 378:898–905. 

36Blair et al. [1983]; Stroup et al. [1986]; ZeigOwens et al. [2011]. 37 Garabrant et al. [1988]; Hauptman M, Lubin JH, 

Stewart PA,Hayes R, Blair A [2004]. Mortality from 

cancers among workers in formaldehyde industries. 

Am J Epidemiol 159:1117–1130; Solan S, 

Wallenstein S, Shapiro M, Teitelbaum SL, 

Stevenson L, Kochman A, Kaplan J, Dellenbaugh C, 

Kahn A, Biro FN, Crane M, Crowley L, Gabrilove 

J, Gonsalves L, Harrison D, Herbert R, Luft B, 

Markowitz SB, Moline J, Niu X, Sacks H, Shukla G, 

Udasin I, Lucchini RG, Boffetta P, Landrigan PJ. 

[2013] Cancer incidence in World Trade Center 

rescue and recovery workers, 2001–2008. Environ 

Health Perspect 121(6):699–704; Zeig-Owens et al. 

[2011]. 

38Anntila et al. [1995]; Blair et al. [1983]; Coggon 

D, Harris EC, Poole J, Palmer KT [2003]. Extended 

follow-up of a cohort of British chemical workers 

exposed to formaldehyde. JNCI 95:1608–1615; 

Davis JR, Brownson, Garcia, R, Bentz BJ, Turner A 

[1993]. Family pesticide use and childhood brain 

cancer. Arch Environ Contam Toxicol 24:87–92; 

Hauptmann et al. [2004]; Pan SY, Ugnat AM, Mao 

Y [2005]. Canadian Cancer Registries Epidemiology 

Research Group. Occupational risk factors for brain 

cancer in Canada. J Occup Environ Med 47: 704– 

717; Solan et al. [2013]; Spirtas et al. [1991]. 

39 Davis et al. [1993]; Li et al. [2012]; Pan et al. 

[2005]. The identification of this limitation offers 

further evidence of the uncertainties associated 

with identifying causes of brain and pancreatic 

cancer. 

40Charbotel B, Fervers B, Droz JP [2013]. 

Occupational exposures in rare cancers: a critical 

review of the literature. Crit Rev Oncol/Hematol. 

http://dx.doi.org/10.1016/j.critrevonc.2013.12.004. 41 28 CFR 104.21. 

difficulty in identifying appropriate 

referent populations (ideally, referent 

populations would have very similar 

demographic characteristics and 

exposures except for the agent being 

studied); 36 (3) the difficulty of 

conducting studies of brain or 

pancreatic cancers, which typically 

have long latency periods, before 

disease symptoms might manifest in 

exposed individuals; 37 (4) inaccurate or 

inconsistent exposure assessment; 38

and (5) observations of multiple health 

effects which may identify statistically 

significant increases in brain or 

pancreatic cancers by chance.39 The 

limitations identified in this review are 

consistent with the findings from other 

reviews of rare cancers.40

Upon re-evaluation of these studies, 

the Administrator finds that brain or 

pancreatic cancer may be associated 

with an exposure, but the studies’ 

limitations prevent adequate evaluation 

of this association. Accordingly, the 

Administrator has determined that the 

availability of numerous studies 

evaluating the associations between 

brain and pancreatic cancers and 

environmental exposures should not be 

given more weight in his decisionmaking than the inherent limitations of 

these studies. While the Administrator 

previously relied on the lack of an 

identified association between 

environmental exposures and brain or 

pancreatic cancers in these 

epidemiologic studies to conclude that 

they should not be considered WTCrelated, he now determines that those 

studies are not likely to identify 

associations because of study 

limitations and concludes that, because 

the uncertainty associated with brain 

and pancreatic cancers is similar to the 

uncertainty associated with other rare 

cancers, they should be similarly 

eligible for consideration as WTCrelated. 

For the reasons discussed above, the 

Administrator has determined that brain 

and pancreatic cancers are considered 

rare cancers, and that they are eligible 

for WTC Health Program certification. 

VI. Effects of Rulemaking on Federal 

Agencies 

Title II of the James Zadroga 9/11 

Health and Compensation Act of 2010 

(Pub. L. 111–347) reactivated the 

September 11th Victim Compensation 

Fund (VCF). Administered by the U.S. 

Department of Justice (DOJ), the VCF 

provides compensation to any 

individual or representative of a 

deceased individual who was physically 

injured or killed as a result of the 

September 11, 2001, terrorist attacks or 

during the debris removal. Eligibility 

criteria for compensation by the VCF 

include a list of presumptively covered 

health conditions, which are physical 

injuries determined to be WTC-related 

health conditions by the WTC Health 

Program. Pursuant to DOJ regulations, 

the VCF Special Master is required to 

update the list of presumptively covered 

conditions when the List of WTCRelated Health Conditions in 42 CFR 

88.1 is updated.41

VII. Issuance of an Interim Final Rule 

With Immediate Effective Date 

In accordance with the provisions of 

the Administrative Procedure Act at 5 

U.S.C. 553(b)(3)(B), the Administrator 

finds good cause to waive the use of 

prior notice and comment procedures 

for issuing this interim final rule (IFR), 

and that the use of such procedures 

would be contrary to the public interest. 

This IFR amends 42 CFR 88.1 to remove 

Table 1 and replace it with a narrative 

list of covered cancers, clarify the 

definition of childhood cancers, and 

revise the definition of rare cancers; it 

also notifies stakeholders that the 

Administrator now considers malignant 

neoplasms of the brain and the pancreas 

to be eligible for coverage as rare 

cancers. The Administrator has 

determined that it is contrary to the 

public interest to delay these necessary 

amendments. Postponement of the 

implementation of these amendments 

could result in real harm to those 

individuals who are currently suffering 

from a subtype of cancer that was 

inadvertently excluded from the 

detailed list of cancer codes, or from a 

rare cancer that was not identified by 

the former prevalence-based numeric 

threshold (U.S. population size of 

200,000 persons), or from cancer of the 

brain or the pancreas. Thus, the 

Administrator is waiving the prior 

notice and comment procedures in the 

interest of protecting the health of WTC 

Health Program members whose cancer 

may now be eligible for certification. 

The amendments to replace Table 1 

with a narrative list of covered cancers 

and clarify the definition of childhood 

cancers will not result in any 

substantive change to the types of 

cancers added to the List of WTCRelated Health Conditions by the final 

rule published on September 12, 2012 

(77 FR 56138) or by the final rule 

published on September 19, 2013 

adding prostate cancer (78 FR 57505); 

however, changing the numeric 

threshold for rare cancers will result in 

of two types of cancer becoming newly 

eligible for consideration as rare 

cancers. Additionally, cancers of the 

brain and the pancreas may now be 

considered for certification as rare 

cancers. The Administrator expects that 

most stakeholders will be supportive of 

the amendments, because the 

determinations established in this 

rulemaking will result in more WTC 

Health Program members becoming 

eligible for certification of a WTCVerDate Mar<15>2010 16:50 Feb 14, 2014 Jkt 232001 PO 00000 Frm 00024 Fmt 4700 Sfmt 4700 E:\FR\FM\18FER1.SGM 18FER1

tkelley on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 79, No. 32 / Tuesday, February 18, 2014 / Rules and Regulations 9107 

42NPRM 77 FR 35574, 35589–35592 (June 13, 

2012); Final rule 77 FR 56138, 56144 (September 

12, 2012). A notice of proposed rulemaking 

proposing to add prostate cancer to the List of WTCRelated Health Conditions was published on July 2, 

2013 (78 FR 39670), and a final rule was published 

on September 19, 2013 (78 FR 57505). 

43Copeland G, Lake A, Firth R, Wohler B,Wu XC, 

Stroup A, Russell C, Boyuk K, Schymura M, 

Hofferkamp J, Kohler B (eds) [2012]. Cancer in 

North America: 2005–2009. Volume One: Combined 

Cancer Incidence for the United States, Canada and 

North America. Springfield, IL: North American 

Association of Central Cancer Registries, Inc. 

44Based on a population of 65,000 at the U.S. 

cancer rate and discounted at 7 percent. 

45Based on a population of 110,000 at 21 percent 

above the U.S. cancer rate and discounted at 3 

percent. 

46These 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.’’ 

47PHS Act, sec. 3311(a)(4)(A) and sec. 

3321(a)(3)(A). 

Related Health Condition. Interested 

parties were given an opportunity to 

comment on the covered cancers during 

the June 2012 notice of proposed 

rulemaking’s 30-day public comment 

period. During the public comment 

period for the initial notice of proposed 

rulemaking, no commenters reflected on 

the proposed definition of ‘‘rare 

cancers.’’ 

Under 5 U.S.C. 553(d)(3), the 

Administrator finds good cause to make 

this IFR effective immediately. As stated 

above, in order to ensure that the WTC 

Health Program is able to promptly 

respond to a member WTC responder or 

survivor who is suffering from a type of 

cancer that may now be eligible for 

certification, including individuals who 

may have been denied certification for 

brain or pancreatic cancer, it is 

necessary that the Administrator act 

quickly to promulgate the amendments 

discussed above. While the amendments 

to § 88.1 are effective on the date of 

publication of this IFR, they are interim 

and will be finalized following the 

receipt of any substantive public 

comments. (See Section II.) 

VIII. Summary of Interim Final Rule 

For the reasons discussed above, the 

Administrator of the WTC Health 

Program is amending 42 CFR 88.1, 

paragraph (4) of the definition of ‘‘List 

of WTC-related health conditions,’’ to 

strike the former regulatory language 

indicating that covered cancer types 

would be specified by ICD–10 and ICD– 

9 codes. The rule is further amended to 

remove Table 1 in its entirety and to 

replace it with the narrative list of 24 

broadly specified cancer types by body 

organ or region included in both the 

2012 notice of proposed rulemaking and 

final rule preambles, as well as prostate 

cancer which was added to the List in 

the September 2013 rulemaking.42

Although the codes and subcodes are 

removed, all of the specifically 

identified types of cancers that were 

added to the List of WTC-Related Health 

Conditions by the September 12, 2012 

final rule, and which were identified in 

Table 1 (as well as prostate cancer, 

added by the September 19, 2013 final 

rule), remain covered by the Program. 

This amendment will have the effect of 

retaining all of the currently covered 

cancer types but will allow WTC Health 

Program staff to administratively 

determine the corresponding codes for 

the specific types of cancer covered by 

the Program, regardless of classification 

system (ICD–9, ICD–10, etc.). 

For the reasons discussed above, the 

Administrator clarifying the definition 

of ‘‘childhood cancers’’ to replace the 

words ‘‘occurring in’’ with ‘‘diagnosed 

in.’’ 

Finally, the Administrator is also 

revising the definition of ‘‘rare cancers’’ 

to remove the 200,000 persons 

prevalence and 0.08 percent incidence 

rate in the former definition and instead 

reflect the revised incidence rate, less 

than 15 cases per 100,000 persons per 

year in the United States based on 

2005–2009 average annual data.43 The 

phrase ‘‘Rare cancers will be determined 

on a case-by-case basis’’ is stricken. 

IX. 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 interim final rule has been 

determined not to be a ‘‘significant 

regulatory action’’ under sec. 3(f) of E.O. 

12866. The amendments in this rule 

modify the format of the list of named 

cancers covered by the WTC Health 

Program, clarify the definition of 

‘‘childhood cancers,’’ and modify the 

definition of ‘‘rare cancers.’’ In addition 

to amendments to the rule text, in this 

action the Administrator also recognizes 

malignant neoplasms of the brain and 

the pancreas as rare cancers. The 

revised definition and determinations 

regarding ‘‘rare cancers,’’ have resulted 

in four additional cancer types being 

considered eligible for coverage under 

the Program: Brain cancer (malignant 

neoplasm of the brain), invasive cervical 

cancer (malignant neoplasm of the 

cervix uteri), pancreatic cancer 

(malignant neoplasm of the pancreas), 

and testicular cancer (malignant 

neoplasm of the testis). Treatment and 

monitoring services for these four 

cancer types is estimated to cost the 

WTC Health Program between 

$2,287,933 44 and $4,933,280 45

annually. All of the costs to the WTC 

Health Program will be transfers after 

the implementation of provisions of the 

Patient Protection and Affordable Care 

Act (Pub. L. 111–148) on January 1, 

2014. 

The Administrator did not identify 

any costs associated with the removal of 

Table 1 from 42 CFR 88.1. 

The rule would not interfere with 

State, local, and Tribal governments in 

the exercise of their governmental 

functions. 

Cost Estimates 

The WTC Health Program has, to date, 

enrolled approximately 58,500 New 

York City responders and approximately 

6,500 survivors, or approximately 

65,000 individuals in total. Of that total 

population, approximately 60,000 

individuals were participants in 

previous WTC medical programs and 

were ‘grandfathered’ into the WTC 

Health Program established by Title 

XXXIII.46 In addition to those 

grandfathered WTC responders and 

survivors already enrolled, the PHS 

Act 47 sets a numeric limitation on the 

number of eligible members who can 

enroll in the WTC Health Program 

beginning July 1, 2011 at 25,000 new 

WTC responders and 25,000 new WTC 

survivors (i.e., the statute restricts new 

enrollment). For the purpose of 

calculating a baseline estimate of cancer 

prevalence only, the Administrator 

assumed that the gradual rate of 

enrollment seen in the Program to date 

would continue, and that Program 

membership would remain around 

58,500 WTC responders and 6,500 WTC 

survivors. The estimate is further based 

on the average U.S. cancer prevalence 

rate and 7 percent discount rate. 

As it is not possible to identify an 

upper bound estimate, the 

Administrator 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 


tkelley on DSK3SPTVN1PROD with RULES
9108 Federal Register / Vol. 79, No. 32 / Tuesday, February 18, 2014 / Rules and Regulations 

48Zeig-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. The Lancet. 378 

(9794): 898–905. 

49 Id. 

50As 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 9/11 

exposure and cancer means that the outcomes 

remain speculative. 

51 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. 

52Surveillance, 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. 

53Bureau of Labor Statistics. Consumer Price 

Index https://research.stlouisfed.org/fred2/series/

CPIMEDSL/downloaddata?cid=32419. Accessed 

April 23, 2012. 

that the entire statutory cap for new 

WTC responders (25,000) and WTC 

survivors (25,000) will be filled. 

Accordingly, this estimate is based on a 

population of 80,000 responders (55,000 

grandfathered + 25,000 new) and 30,000 

survivors (5,000 grandfathered + 25,000 

new). The upper cost estimate also 

assumes an overall increase in 

population cancer rates (for malignant 

neoplasm of the brain [brain cancer], 

malignant neoplasm of the cervix uteri 

[invasive cervical cancer], malignant 

neoplasm of the pancreas [pancreatic 

cancer], malignant neoplasm of the 

testis [testicular cancer]) of 21 percent 

due to 9/11 exposure,48 and costs were 

discounted at 3 percent. The choice of 

a 21 percent increase in the risk of 

cancer of the rate found in the 

unexposed population is based on 

findings presented in the first published 

epidemiologic study of September 11, 

2001 exposed populations.49 Given the 

challenges associated with interpreting 

the Zeig-Owens findings,50 this analysis 

uses 21 percent as a possible outcome 

rather than asserting the probability that 

21 percent is a ‘‘likely’’ outcome. 

The Administrator acknowledges that 

some cancer cases are not likely to have 

been caused by 9/11 exposures. The 

certification of individual cancer 

diagnoses will be conducted on a caseby-case basis. However, for the purpose 

of this analysis, the Administrator has 

estimated that all diagnosed cancers 

added to the List or meeting the 

definition of rare cancer will be certified 

for treatment by the WTC Health 

Program. Finally, because there are no 

existing data on cancer rates related to 

9/11 exposures at either the Pentagon or 

in Shanksville, Pennsylvania, the 

Administrator has used only data from 

studies of individuals who were 

responders or survivors in the New York 

City disaster area. 

Costs of Cancer Treatment 

The Administrator estimated the 

treatment costs associated with covering 

malignant neoplasm of the brain, 

malignant neoplasm of the cervix uteri, 

malignant neoplasm of the pancreas, 

and malignant neoplasm of the testis in 

this rulemaking using the methods 

described below. Costs associated with 

cancer screening are discussed 

separately below. 

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 A. The 

costs of treatment are divided into three 

phases: The costs for the first year 

following diagnosis, the costs of 

intervening years or continuing 

treatment after the first year, and the 

costs of treatment for the last year of 

life. The first year costs of cancer 

treatment are higher due to the initial 

need for aggressive medical (e.g., 

radiation, chemotherapy) and surgical 

care. The costs during last year of life 

are often dominated by increased 

hospitalization costs. Therefore, this 

analysis uses 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.51

TABLE A—AVERAGE COSTS OF TREATMENT, MALE AND FEMALE (2011) 

Type of cancer 

Initial 

(first 12 months 

after diagnosis) 

Continuing 

(annual) 

Last year of life 

(last 12 months 

of life) 

Brain ................................................................................................................................. $87,319 $6,372 $101,372 

Pancreas .......................................................................................................................... 74,205 5,270 84,809 

Cervix Uteri ...................................................................................................................... 33,945 1,072 36,503 

Testis + ............................................................................................................................. 13,696 2,754 43,481 

+ Approximated by the costs of other tumor sites. 

These cost figures were based on a 

study of elderly cancer patients from the 

Surveillance, Epidemiology, and End 

Results (SEER) program maintained by 

the National Cancer Institute using 

Medicare files.52 The average costs of 

treatment described above are given in 

2011 prices adjusted using the Medical 

Consumer Price Index for all urban 

consumers.53

Incident Cases of Cancer 

The Administrator estimated the 

expected number of cases of cancer that 

would be observed in a cohort of 

responders and survivors followed for 

cancer incidence after September 11, 

2001 using U.S. population cancer rates 

for the four cancer types considered 

eligible for coverage under the Program 

pursuant to 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. Because invasive 

cervical cancer occurs only in females 

and testicular cancer only occurs in 

males, the calculations take into account 

the applicable gender of the WTC 

Health Program members for the 

respective cancer type. The age 

distribution for current enrollees by 

gender and responder/survivor status is 

presented in Table B. 


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Federal Register / Vol. 79, No. 32 / Tuesday, February 18, 2014 / Rules and Regulations 9109 

54 Jordan HT, Brackbill RM, Cone JE, 

Debchoudhury I, Farfel MR, Greene CM, Hadler JL, 

Kennedy J, Li J, Liff J, Stayner L, Stellman SD 

[2011]. Mortality Among Survivors of the Sept 11, 

2001, Word Trade Center Disaster: Results from the 

World Trade Center Health Registry Cohort. The 

Lancet 378:879–887. Note: Percentages may not 

sum to 100 percent due to rounding. 

55Centers for Disease Control and Prevention, 

National Center for Health Statistics. Compressed 

Mortality File 1999–2008. CDC WONDER Online 

Database, compiled from Compressed Mortality File 

1999–2008 Series 20 No. 2N, 2011. http://

wonder.cdc.gov/cmf-icd10.html. Accessed February 

15, 2012. 

56Schubauer-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. 

57National Cancer Institute, Surveillance 

Epidemiology and End Results (SEER). http://

seer.cancer.gov/. Accessed May 27, 2012. 

58 Id. 

59The 15-year survival limit is imposed based on 

the analytic time horizon established between the 

triggering events of September 11, 2001 and the 

authorization of the WTC Health Program through 

2016. 

60National Cancer Institute, Surveillance 

Epidemiology and End Results (SEER). http://

seer.cancer.gov/. Accessed May 27, 2012. 

TABLE B—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 

Male survivors .................................................................. 12 23 35 46 52 58 67 81 99 

Female survivors .............................................................. 12 21 38 49 54 60 68 84 95 

The Administrator assumed race and 

ethnic origin distributions for 

responders and survivors according to 

distributions in the WTC Health 

Registry cohort: 54 57 percent nonHispanic white, 15 percent nonHispanic 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 individuals 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 

individuals 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).55 A life-table analysis 

program, LTAS.NET, was used to 

estimate the expected number of 

incident cancers for cancer types 

added.56 The Administrator calculated 

cancer incidence rates using data 

through 2006 from the Surveillance 

Epidemiology and End Results (SEER) 

Program, and estimated rates for 2007– 

2016.57 The Program applied the 

resulting gender, race, age, and yearspecific cancer incidence rates to the 

estimated person-years at risk to 

estimate the expected number of cancer 

cases for each cancer type starting from 

year 2002, the first full year following 

the September 11, 2001, terrorist 

attacks, to 2016, the last year for which 

this Program is currently funded. 

Prevalence of Cancer 

To determine the potential number of 

individuals in the responder and 

survivor populations with cancer, the 

Administrator used the number of 

incident cases described above for each 

year starting with 2002 and estimated 

the prevalence of cancer using survival 

rate statistics for each incident cancer 

group through 2016.58

Using the incident cases and survival 

rate statistics for each cancer type, the 

Administrator has estimated the 

prevalence (number of individuals 

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 individuals surviving up to 

15 years beyond their first diagnosis 

(prevalence).59 For example, in 2002 

there are 6.82 projected new cases of 

testicular cancer, which would be listed 

as incident cases for that year. The 

survival rate for testicular cancer in the 

first year of diagnosis is 94.68 percent.60

Therefore the number of deceased 

individuals in 2002 would be 6.82 × 

(1¥0.9468) = 0.36. For the testicular 

cancer prevalence table, in year 2003, 

the number of incident cases would be 

6.61 cases. In addition to 6.61 newly 

diagnosed cases in 2003, there would be 

the one-year survivors from 2002 which 

would be 6.82¥0.36 (or 6.82 × 0.9468) 

= 6.46 cases. This computation process 

can be repeated for each year through 

year 2016. A portion of the brain, 

invasive cervical, pancreatic, and 

testicular cancers prevalence tables are 

provided in Table C1, C2, C3, and C4 

respectively. 

Prevalence tables were created for 

each type of covered cancer and the 

results are summarized in Tables E and 

G. This analysis considers cancers 

diagnosed in 2002 through 2016. 

TABLE C1—PREVALENCE TABLE FOR BRAIN CANCER

[Based on 80,000 responders] 

Year Years since exposure to 9/11 agents Years covered by WTC Health Program 

New/surv. 2002 2003 2012 2013 2014 2015 2016 

1 ............................................................................. 4.38 4.54 6.18 6.43 6.70 6.94 7.20 

2 ............................................................................. .................. 2.73 3.69 3.85 4.01 4.18 4.32 

3 ............................................................................. .................. .................. 2.58 2.68 2.80 2.91 3.04 

4 ............................................................................. .................. .................. 2.24 2.34 2.43 2.53 2.64 


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9110 Federal Register / Vol. 79, No. 32 / Tuesday, February 18, 2014 / Rules and Regulations 

TABLE C1—PREVALENCE TABLE FOR BRAIN CANCER—Continued 

[Based on 80,000 responders] 

Year Years since exposure to 9/11 agents Years covered by WTC Health Program 

New/surv. 2002 2003 2012 2013 2014 2015 2016 

5 ............................................................................. .................. .................. 2.02 2.11 2.20 2.28 2.38 

6 ............................................................................. .................. .................. 1.85 1.93 2.01 2.10 2.18 

7 ............................................................................. .................. .................. 1.72 1.79 1.87 1.95 2.03 

8 ............................................................................. .................. .................. 1.58 1.64 1.71 1.78 1.86 

9 ............................................................................. .................. .................. 1.59 1.56 1.63 1.69 1.76 

10 ........................................................................... .................. .................. 1.48 1.54 1.52 1.58 1.65 

11 ........................................................................... .................. .................. 1.39 1.44 1.50 1.47 1.54 

12 ........................................................................... .................. .................. .................. 1.36 1.41 1.47 1.45 

13 ........................................................................... .................. .................. .................. .................. 1.32 1.37 1.42 

14 ........................................................................... .................. .................. .................. .................. .................. 1.30 1.35 

15 ........................................................................... .................. .................. .................. .................. .................. .................. 1.25 

Live cases from previous years ............................. .................. .................. 20.15 22.25 24.39 26.61 28.85 

Prevalence ............................................................. .................. .................. 26.32 28.68 31.09 33.55 36.05 

Last year of life ...................................................... 1.65 2.46 4.07 4.29 4.49 4.70 4.91 

TABLE C2—PREVALENCE TABLE FOR INVASIVE CERVICAL CANCER

[Based on 80,000 responders] 

Year Years since 9/11 exposures Years covered by WTC Health Program 

New/surviving 2002 2003 2012 2014 2015 2016 

1 ....................................................................................... 1.17 1.21 1.24 1.23 1.22 1.22 

2 ....................................................................................... .................... 1.06 1.12 1.12 1.12 1.11 

3 ....................................................................................... .................... .................... 1.01 1.01 1.00 1.00 

4 ....................................................................................... .................... .................... 0.95 0.95 0.95 0.95 

5 ....................................................................................... .................... .................... 0.91 0.92 0.92 0.92 

6 ....................................................................................... .................... .................... 0.87 0.89 0.89 0.89 

7 ....................................................................................... .................... .................... 0.86 0.88 0.88 0.89 

8 ....................................................................................... .................... .................... 0.83 0.86 0.87 0.87 

9 ....................................................................................... .................... .................... 0.87 0.84 0.85 0.86 

10 ..................................................................................... .................... .................... 0.84 0.82 0.83 0.84 

11 ..................................................................................... .................... .................... 0.81 0.86 0.82 0.83 

12 ..................................................................................... .................... .................... .................... 0.83 0.85 0.81 

13 ..................................................................................... .................... .................... .................... 0.80 0.82 0.85 

14 ..................................................................................... .................... .................... .................... .................... 0.80 0.82 

15 ..................................................................................... .................... .................... .................... .................... .................... 0.79 

Live cases from previous years ....................................... .................... .................... 9.06 10.76 11.60 12.42 

Prevalence ....................................................................... 1.17 2.27 10.30 12.00 12.82 13.63 

Last year of life ................................................................ 0.11 0.23 0.38 0.40 0.41 0.41 

TABLE C3—PREVALENCE TABLE FOR PANCREATIC CANCER

[Based on 80,000 responders] 

Year Years since exposure to 9/11 agents Years covered by WTC Health Program 

New/surv. 2002 2003 2012 2013 2014 2015 2016 

1 ............................................................................. 3.43 3.80 8.93 9.73 10.56 11.34 12.21 

2 ............................................................................. .................. 0.98 2.34 2.56 2.79 3.03 3.26 

3 ............................................................................. .................. .................. 0.99 1.08 1.18 1.29 1.40 

4 ............................................................................. .................. .................. 0.56 0.61 0.67 0.73 0.80 

5 ............................................................................. .................. .................. 0.42 0.46 0.51 0.55 0.61 

6 ............................................................................. .................. .................. 0.31 0.34 0.38 0.41 0.45 

7 ............................................................................. .................. .................. 0.26 0.29 0.31 0.35 0.38 

8 ............................................................................. .................. .................. 0.22 0.24 0.27 0.30 0.32 

9 ............................................................................. .................. .................. 0.20 0.22 0.24 0.27 0.30 

10 ........................................................................... .................. .................. 0.17 0.19 0.20 0.23 0.25 

11 ........................................................................... .................. .................. 0.14 0.15 0.17 0.18 0.20 

12 ........................................................................... .................. .................. .................. 0.13 0.14 0.16 0.17 

13 ........................................................................... .................. .................. .................. .................. 0.12 0.13 0.15 

14 ........................................................................... .................. .................. .................. .................. .................. 0.12 0.13 

15 ........................................................................... .................. .................. .................. .................. .................. .................. 0.11 

Live cases from previous years ............................. .................. .................. 5.60 6.27 6.98 7.74 8.51 

Prevalence ............................................................. 3.43 4.78 14.53 15.87 17.28 18.67 20.17 

Last year of life ...................................................... 2.45 3.24 8.25 9.02 9.80 10.57 11.39 


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Federal Register / Vol. 79, No. 32 / Tuesday, February 18, 2014 / Rules and Regulations 9111 

TABLE C4—PREVALENCE TABLE FOR TESTICULAR CANCER

[Based on 80,000 responders] 

Year Years since 9/11 exposures Years covered by WTC Health Program 

New/surviving 2002 2003 2012 2014 2015 2016 

1 ....................................................................................... 6.82 6.61 4.23 3.72 3.44 3.20 

2 ....................................................................................... .................... 6.46 4.24 3.76 3.52 3.26 

3 ....................................................................................... .................... .................... 4.27 3.80 3.56 3.34 

4 ....................................................................................... .................... .................... 4.41 3.93 3.71 3.48 

5 ....................................................................................... .................... .................... 4.60 4.13 3.89 3.67 

6 ....................................................................................... .................... .................... 4.80 4.33 4.10 3.86 

7 ....................................................................................... .................... .................... 5.02 4.55 4.32 4.09 

8 ....................................................................................... .................... .................... 5.20 4.78 4.54 4.31 

9 ....................................................................................... .................... .................... 5.47 5.00 4.77 4.54 

10 ..................................................................................... .................... .................... 5.65 5.19 5.00 4.77 

11 ..................................................................................... .................... .................... 5.78 5.42 5.14 4.96 

12 ..................................................................................... .................... .................... .................... 5.57 5.38 5.11 

13 ..................................................................................... .................... .................... .................... 5.73 5.55 5.36 

14 ..................................................................................... .................... .................... .................... .................... 5.70 5.53 

15 ..................................................................................... .................... .................... .................... .................... .................... 5.66 

Live cases from previous years ....................................... .................... .................... 49.45 56.18 59.19 61.93 

Prevalence ....................................................................... 6.82 13.07 53.68 59.89 62.63 65.13 

Last year of life ................................................................ 0.36 0.68 0.75 0.70 0.70 0.68 

Cost Computation 

To compute the costs for each type of 

cancer, the Administrator assumes that 

all of the individuals who are diagnosed 

with a cancer type will be certified by 

the WTC Health Program for treatment 

services. The treatment costs for the first 

year of treatment (Table A, 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 

A were applied to the number of 

prevalent cases who had survived their 

cancers beyond their year of diagnosis, 

for each year of survival (Year 2–15). 

Using this procedure, a cost table was 

constructed for each year covered by the 

WTC Health Program and the results are 

presented in Tables D1, D2, D3, and D4. 

The row for Year 1 in each table is the 

cost of incident cases for that year. Rows 

for Years 2–15 show the cost from 

continuing care for individuals 

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 

by the number of individuals dying in 

that year from that type of cancer from 

Tables C1–C4. 

TABLE D1—COST PER 80,000 RESPONDERS FOR BRAIN CANCER, 2011$ 

Year 

Years covered by the WTC Health Program 

2014 2015 2016 

1 ....................................................................................................................................... $364,737 $377,541 $391,595 

2 ....................................................................................................................................... 25,526 26,617 27,552 

3 ....................................................................................................................................... 17,833 18,569 19,363 

4 ....................................................................................................................................... 15,463 16,128 16,793 

5 ....................................................................................................................................... 14,003 14,535 15,160 

6 ....................................................................................................................................... 12,812 13,365 13,872 

7 ....................................................................................................................................... 11,906 12,404 12,939 

8 ....................................................................................................................................... 10,899 11,358 11,832 

9 ....................................................................................................................................... 10,369 10,786 11,240 

10 ..................................................................................................................................... 9,661 10,080 10,485 

11 ..................................................................................................................................... 9,543 9,384 9,791 

12 ..................................................................................................................................... 9,015 9,367 9,211 

13 ..................................................................................................................................... 8,391 8,710 9,050 

14 ..................................................................................................................................... ............................ 8,261 8,574 

15 ..................................................................................................................................... ............................ ............................ 7,967 

Prevalent care .................................................................................................................. 520,157 547,103 567,459 

Last year of life care ........................................................................................................ 454,701 476,561 497,829 

Total .......................................................................................................................... 974,859 1,023,664 1,065,288 

TABLE D2—COST PER 80,000 RESPONDERS FOR INVASIVE CERVICAL CANCER, 2011$ 

Year 

Years covered by the WTC Health Program 

2014 2015 2016 

1 ....................................................................................................................................... $37,922 $37,599 $37,379 


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9112 Federal Register / Vol. 79, No. 32 / Tuesday, February 18, 2014 / Rules and Regulations 

TABLE D2—COST PER 80,000 RESPONDERS FOR INVASIVE CERVICAL CANCER, 2011$—Continued 

Year 

Years covered by the WTC Health Program 

2014 2015 2016 

2 ....................................................................................................................................... 1,200 1,198 1,188 

3 ....................................................................................................................................... 1,078 1,075 1,073 

4 ....................................................................................................................................... 1,021 1,022 1,019 

5 ....................................................................................................................................... 984 983 984 

6 ....................................................................................................................................... 951 957 956 

7 ....................................................................................................................................... 938 944 951 

8 ....................................................................................................................................... 919 928 933 

9 ....................................................................................................................................... 902 911 920 

10 ..................................................................................................................................... 880 894 903 

11 ..................................................................................................................................... 917 875 889 

12 ..................................................................................................................................... 893 916 873 

13 ..................................................................................................................................... 858 883 906 

14 ..................................................................................................................................... ............................ 853 878 

15 ..................................................................................................................................... ............................ ............................ 843 

Prevalent care .................................................................................................................. 49,464 50,039 49,854 

Last year of life care ........................................................................................................ 14,485 14,806 15,008 

Total .......................................................................................................................... 63,949 64,845 64,862 

TABLE D3—COST PER 80,000 RESPONDERS FOR PANCREATIC CANCER, 2011$ 

Year 

Years covered by the WTC Health Program 

2014 2015 2016 

1 ....................................................................................................................................... $224,967 $241,545 $260,083 

2 ....................................................................................................................................... 14,713 15,977 17,155 

3 ....................................................................................................................................... 6,232 6,791 7,374 

4 ....................................................................................................................................... 3,516 3,858 4,204 

5 ....................................................................................................................................... 2,671 2,908 3,190 

6 ....................................................................................................................................... 1,989 2,174 2,367 

7 ....................................................................................................................................... 1,660 1,818 1,988 

8 ....................................................................................................................................... 1,411 1,556 1,705 

9 ....................................................................................................................................... 1,273 1,411 1,556 

10 ..................................................................................................................................... 1,072 1,188 1,317 

11 ..................................................................................................................................... 871 957 1,061 

12 ..................................................................................................................................... 757 836 919 

13 ..................................................................................................................................... 627 694 767 

14 ..................................................................................................................................... ............................ 627 694 

15 ..................................................................................................................................... ............................ ............................ 570 

Prevalent care .................................................................................................................. 261,759 282,340 304,378 

Last year of life care ........................................................................................................ 831,446 896,398 965,711 

Total .......................................................................................................................... 1,093,205 1,178,738 1,270,089 

TABLE D4—COST PER 80,000 RESPONDERS FOR TESTICULAR CANCER, 2011$ 

Year 

Years covered by the WTC Health Program 

2014 2015 2016 

1 ....................................................................................................................................... $48,191 $44,628 $41,507 

2 ....................................................................................................................................... 10,348 9,691 8,974 

3 ....................................................................................................................................... 10,456 9,816 9,193 

4 ....................................................................................................................................... 10,817 10,208 9,584 

5 ....................................................................................................................................... 11,373 10,705 10,102 

6 ....................................................................................................................................... 11,930 11,294 10,630 

7 ....................................................................................................................................... 12,541 11,888 11,254 

8 ....................................................................................................................................... 13,152 12,512 11,859 

9 ....................................................................................................................................... 13,779 13,136 12,497 

10 ..................................................................................................................................... 14,303 13,779 13,136 

11 ..................................................................................................................................... 14,918 14,167 13,649 

12 ..................................................................................................................................... 15,327 14,829 14,082 

13 ..................................................................................................................................... 15,768 15,272 14,775 

14 ..................................................................................................................................... ............................ 15,711 15,217 

15 ..................................................................................................................................... ............................ ............................ 15,597 


tkelley on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 79, No. 32 / Tuesday, February 18, 2014 / Rules and Regulations 9113 

61Zeig-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. The 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 9/11-exposure and 

cancer outcomes; and potential unmeasured 

confounders. 

TABLE D4—COST PER 80,000 RESPONDERS FOR TESTICULAR CANCER, 2011$—Continued 

Year 

Years covered by the WTC Health Program 

2014 2015 2016 

Prevalent care .................................................................................................................. 202,903 207,634 196,458 

Last year of life care ........................................................................................................ 30,644 30,588 29,604 

Total .......................................................................................................................... 233,548 238,222 226,062 

The sum of the annual costs in each 

table for the years 2014 through 2016 

represents the estimated treatment costs 

to the WTC Health Program for coverage 

of brain, invasive cervical, pancreatic, 

and testicular cancers, respectively, for 

80,000 responders. The cost projections 

in Tables D1, D2, D3, and D4 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 recomputed under the following two 

assumptions: (1) The rate of cancer in 

the WTC Health Program is equal to the 

rate of cancer observed in the general 

population; and (2) the rate of cancer 

exceeds the general population rate by 

21 percent due to their 9/11 

exposures.61

A summary of the estimated 

prevalence at the U.S. population 

average for the assumed population of 

58,500 responders and 6,500 survivors 

is provided in Table E. A summary of 

the estimated treatment costs to the 

WTC Health Program is provided in 

Table F. 

A summary of the estimated 

prevalence using cancer rates 21 percent 

over the U.S. population average for the 

increased rate of 80,000 responders and 

30,000 survivors is given in Table G. A 

summary of the estimated treatment 

costs to the WTC Health Program is 

provided in Table H. 

TABLE E—ESTIMATED PREVALENCE BY YEAR AND CANCER TYPE BASED ON 58,500 AND 6,500 RESPONDER AND

SURVIVOR POPULATION, RESPECTIVELY AND ASSUMING CANCER RATES AT U.S. POPULATION AVERAGE

Cancer type 

Prevalence (incident + live cases) 

2014 2015 2016 

Based on 58,500 responder population 

Brain ................................................................................................................................. 22.74 24.53 26.36 

Cervix Uteri ...................................................................................................................... 8.77 9.38 9.97 

Pancreas .......................................................................................................................... 12.83 13.95 15.16 

Testis ............................................................................................................................... 43.80 45.80 47.62 

Total .......................................................................................................................... 88.14 93.66 99.11 

Based on 6,500 survivor population 

Brain ................................................................................................................................. 2.53 2.73 2.93 

Cervix Uteri ...................................................................................................................... 0.97 1.04 1.11 

Pancreas .......................................................................................................................... 1.43 1.55 1.68 

Testis ............................................................................................................................... 4.87 5.09 5.29 

Total .......................................................................................................................... 9.79 10.41 11.01 

TABLE F—ESTIMATED TREATMENT COSTS BY YEAR AND CANCER TYPE BASED ON 58,500 AND 6,500 RESPONDER AND

SURVIVOR POPULATION, RESPECTIVELY AND ASSUMING CANCER RATES AT U.S. POPULATION AVERAGE (2011 $) 

Cancer type 2014 2015 2016 2014–2016 

Based on 58,500 responder population 

Brain ................................................................................................. $712,865 $748,555 $778,992 $2,240,412 

Cervix Uteri ...................................................................................... 46,763 47,418 47,430 153,115 

Pancreas .......................................................................................... 799,406 861,952 928,753 2,590,111 

Testis ............................................................................................... 170,782 174,200 165,308 552,115 

Total .......................................................................................... 1,729,816 1,832,125 1,920,482 5,482,423 


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9114 Federal Register / Vol. 79, No. 32 / Tuesday, February 18, 2014 / Rules and Regulations 

TABLE F—ESTIMATED TREATMENT COSTS BY YEAR AND CANCER TYPE BASED ON 58,500 AND 6,500 RESPONDER AND

SURVIVOR POPULATION, RESPECTIVELY AND ASSUMING CANCER RATES AT U.S. POPULATION AVERAGE (2011 $)— 

Continued 

Cancer type 2014 2015 2016 2014–2016 

Based on 6,500 survivor population 

Brain ................................................................................................. 76,302 79,634 82,372 238,308 

Cervix Uteri ...................................................................................... 32,741 33,935 33,944 108,512 

Pancreas .......................................................................................... 116,940 124,458 132,382 373,780 

Testis ............................................................................................... 13,130 13,333 12,728 42,417 

Total .......................................................................................... 239,113 251,360 261,426 751,898 

Total 

Brain ................................................................................................. 789,167 828,189 861,364 2,478,720 

Pancreas .......................................................................................... 916,346 986,410 1,061,135 2,963,891 

Cervix Uteri ...................................................................................... 79,504 81,353 81,374 261,627 

Testis ............................................................................................... 183,911 187,533 178,036 594,532 

Total .......................................................................................... 1,968,928 2,083,485 2,181,909 6,298,770 

TABLE G—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

Cancer type 

Prevalence (incident + live cases) 

2014 2015 2016 

Based on 80,000 responder population 

Brain ................................................................................................................................. 37.62 40.60 43.62 

Cervix Uteri ...................................................................................................................... 14.52 15.52 16.50 

Pancreas .......................................................................................................................... 21.23 23.09 25.08 

Testis ............................................................................................................................... 72.47 75.78 78.80 

Total .......................................................................................................................... 145.84 154.98 163.99 

Based on 30,000 survivor population 

Brain ................................................................................................................................. 14.11 15.22 16.36 

Cervix Uteri ...................................................................................................................... 5.44 5.82 6.19 

Pancreas .......................................................................................................................... 7.96 8.66 9.40 

Testis ............................................................................................................................... 27.18 28.42 29.55 

Total .......................................................................................................................... 54.69 58.12 61.50 

TABLE H—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 2014 2015 2016 2014–2016 

Based on 80,000 responder population 

Brain ................................................................................................. 1,199,076 1,259,107 1,310,304 3,768,487 

Cervix Uteri ...................................................................................... 78,658 79,760 79,780 238,198 

Pancreas .......................................................................................... 1,344,642 1,449,848 1,562,209 4,356,699 

Testis ............................................................................................... 287,263 293,014 278,056 858,333 

Total .......................................................................................... 2,909,639 3,081,728 3,230,350 9,221,717 

Based on 30,000 survivor population 

Brain ................................................................................................. 355,098 370,605 383,345 1,109,048 

Cervix Uteri ...................................................................................... 152,371 157,927 157,972 468,270 

Pancreas .......................................................................................... 544,220 579,209 616,087 1,739,515 


tkelley on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 79, No. 32 / Tuesday, February 18, 2014 / Rules and Regulations 9115 

62U.S. Preventive Services Task Force [2012]. 

Recommendation: Screening for Cervical Cancer. 

http://www.uspreventiveservicestaskforce.org/

uspstf/uspscerv.htm. Accessed June 26, 2013. 

TABLE H—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 $)—Continued 

Cancer type 2014 2015 2016 2014–2016 

Testis ............................................................................................... 61,103 62,050 59,234 182,387 

Total .......................................................................................... 1,112,792 1,169,790 1,216,638 3,499,221 

Total 

Brain ................................................................................................. 1,554,174 1,629,712 1,693,649 4,877,535 

Cervix Uteri ...................................................................................... 231,029 237,686 237,752 706,468 

Pancreas .......................................................................................... 1,888,862 2,029,057 2,178,296 6,096,215 

Testis ............................................................................................... 348,366 355,063 337,290 1,040,719 

Total .......................................................................................... 4,022,431 4,251,519 4,446,987 12,720,937 

Cost of Cancer Screening 

Costs of screening have been added to 

the summary estimates table below. The 

screening indicated by this rulemaking 

follows U.S. Preventive Services Task 

Force (USPSTF) guidelines. The 

USPSTF recommends cervical cancer 

screening but does not recommend 

screening for brain, pancreatic, or 

testicular cancer. For cervical cancer, 

USPSTF recommends that females age 

21–65 receive one Pap test every 3 

years; females age 30–65, are 

recommended to receive one HPV 

screening every 5 years.62 Costs for 

screening were distributed according to 

these recommended screening rates. The 

cost for cytology (Pap test) was 

estimated at between $26 and $78 per 

person and the cost for HPV screening 

at between $35 and $77 per person 

based on current FECA rates. 

Summary of Costs 

Because the Administrator lacks data 

to account for either recoupment by 

health insurance or workers’ 

compensation insurance or reduction by 

either health insurance or Medicare/

Medicaid payments, the estimates 

offered here are reflective of estimated 

WTC Health Program costs only. This 

analysis offers an assumption about the 

number of individuals who might enroll 

in the WTC Health Program, and 

estimates the impact of both a low rate 

of cancer (U.S. population average rate) 

and an increased rate (21 percent greater 

than the U.S. population average) on the 

number of cases and the resulting 

estimated treatment costs to the WTC 

Health Program. This analysis does not 

include administrative costs associated 

with certifying additional diagnoses of 

cancers that are WTC-related health 

conditions that might result from this 

action. Those costs were addressed in 

the interim final rule that established 

regulations for the WTC Health Program 

(76 FR 38914, July 1, 2011). 

After the implementation of 

provisions of the Patient Protection and 

Affordable Care Act (Pub. L. 111–148) 

on January 1, 2014, all of the members 

and future members can be assumed to 

have or have access to medical 

insurance coverage other than through 

the WTC Health Program. Therefore, all 

treatment and screening costs to be paid 

by the WTC Health Program from 2014 

through 2016 are considered transfers. 

Table I describes the allocation of 

WTC Health Program transfer payments 

based on 58,500 responders and 6,500 

survivors and, alternatively, 80,000 

responders and 30,000 survivors. 

TABLE I—BREAKDOWN OF ESTIMATED ANNUAL WTC HEALTH PROGRAM COSTS AND TRANSFERS, 58,500 AND 80,000 

RESPONDERS AND 6,500 AND 30,000 SURVIVORS, 2014–2016, 2011$ 

Annualized transfers for 2014– 

2016, 2011$ 

Discounted at 7 

percent 

Discounted at 3 

percent 

Cancer rate 

U.S. average U.S. + 21% 

58,500 Responders ......................................................................................................................................... $1,706,502 ............................

6,500 Survivors ................................................................................................................................................ 234,123 ............................

Cervical cancer screening ............................................................................................................................... 347,368 ............................

65,000 Total ...................................................................................................................................... 2,287,993 ............................

80,000 Responders ......................................................................................................................................... ............................ $2,982,174 

30,000 Survivors .............................................................................................................................................. ............................ 1,131,770 

Cervical cancer screening ............................................................................................................................... ............................ 819,336 

110,000 Total .................................................................................................................................... ............................ 4,933,280 


tkelley on DSK3SPTVN1PROD with RULES
9116 Federal Register / Vol. 79, No. 32 / Tuesday, February 18, 2014 / Rules and Regulations 

63Ward 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. 

Examination of Benefits (Health Impact) 

This section describes qualitatively 

the potential benefits of the interim final 

rule in terms of the expected 

improvements in the health and healthrelated quality of life of potential cancer 

patients treated through the WTC Health 

Program, compared to no Program. The 

assessment of the health benefits for 

cancer patients uses the number of 

expected cancer cases that was 

estimated in the cost analysis section. 

The Administrator does not have 

information on the health of the 

population that may have experienced 

9/11 exposures and is not currently 

enrolled in the WTC Health Program. In 

addition, the Administrator has only 

limited information about health 

insurance and health care services for 

cancers caused by 9/11 exposures and 

suffered by any population of 

responders and survivors, including 

responders and survivors currently 

enrolled in the WTC Health Program 

and responders and survivors not 

enrolled in the Program. For the 

purposes of this analysis, the 

Administrator assumes that broad 

trends on demographics and access to 

health insurance reported by the U.S. 

Census Bureau and health care services 

for cancer similar to those reported by 

Ward et al.63 would apply to the 

population of general responders (those 

individuals who are not members of the 

FDNY and who meet the eligibility 

criteria in 42 CFR Part 88 for WTC 

responders) and survivors both within 

and outside the Program. For the 

purposes of this analysis, the 

Administrator assumes that access to 

health insurance and health care 

services for FDNY responders within 

and outside the Program would be 

equivalent because this population is 

likely covered by employer-based health 

insurance. 

Although the Administrator cannot 

quantify the benefits associated with the 

WTC Health Program, enrollees with 

cancer would have improved access to 

care and thereby the Program should 

produce better treatment outcomes than 

in its absence. Under other insurance 

plans, patients would have deductibles 

and copays, which impact access to care 

and particularly its timeliness. WTC 

Health Program members would have 

first-dollar coverage and hence are 

likely to seek care sooner when 

indicated, resulting in improved 

treatment outcomes. 

Limitations 

The analysis presented here was 

limited by the dearth of verifiable data 

on the cancer status of responders and 

survivors who have yet to apply for 

enrollment in the WTC Health Program. 

Because of the limited data, the 

Administrator was not able to estimate 

benefits in terms of averted healthcare 

costs. Nor was the Administrator able to 

estimate administrative costs, or 

indirect costs, such as averted 

absenteeism, short and long-term 

disability, and productivity losses 

averted due to premature mortality. 

B. Regulatory Flexibility Act 

The Regulatory Flexibility Act (RFA), 

5 U.S.C. 601 et seq., requires each 

agency to consider the potential impact 

of its regulations on small entities 

including small businesses, small 

governmental units, and small not-forprofit organizations. The Administrator 

certifies that this rule has ‘‘no 

significant economic impact upon a 

substantial number of small entities’’ 

within the meaning of the Regulatory 

Flexibility Act (5 U.S.C. 601 et seq.). 

C. Paperwork Reduction Act 

The Paperwork Reduction Act (PRA), 

44 U.S.C. 3501 et seq., requires an 

agency to invite public comment on, 

and to obtain OMB approval of, any 

regulation that requires 10 or more 

people to report information to the 

agency or to keep certain records. Data 

collection and recordkeeping 

requirements for the WTC Health 

Program are approved by OMB under 

‘‘World Trade Center Health Program 

Enrollment, Appeals & Reimbursement’’ 

(OMB Control No. 0920–0891, exp. 

December 31, 2014). The Administrator 

has determined that no changes are 

needed to the information collection 

request already approved by OMB. 

D. Small Business Regulatory 

Enforcement Fairness Act 

As required by Congress under the 

Small Business Regulatory Enforcement 

Fairness Act of 1996 (5 U.S.C. 801 et 

seq.), HHS will report the promulgation 

of this rule to Congress prior to its 

effective date. 

E. Unfunded Mandates Reform Act of 

1995 

Title II of the Unfunded Mandates 

Reform Act of 1995 (2 U.S.C. 1531 et 

seq.) directs agencies to assess the 

effects of Federal regulatory actions on 

State, local, and Tribal governments, 

and the private sector ‘‘other than to the 

extent that such regulations incorporate 

requirements specifically set forth in 

law.’’ For purposes of the Unfunded 

Mandates Reform Act, this interim final 

rule does not include any Federal 

mandate that may result in increased 

annual expenditures in excess of $100 

million in 1995 dollars by State, local or 

Tribal governments in the aggregate, or 

by the private sector. However, the rule 

may result in an increase in the 

contribution made by New York City for 

treatment and monitoring, as required 

by the PHS Act § 3331(d)(2). For 2013, 

the inflation adjusted threshold is $150 

million. 

F. Executive Order 12988 (Civil Justice) 

This interim final rule has been 

drafted and reviewed in accordance 

with Executive Order 12988, ‘‘Civil 

Justice Reform,’’ and will not unduly 

burden the Federal court system. This 

rule has been reviewed carefully to 

eliminate drafting errors and 

ambiguities. 

G. Executive Order 13132 (Federalism) 

The Administrator has reviewed this 

interim final rule in accordance with 

Executive Order 13132 regarding 

federalism, and has determined that it 

does not have ‘‘federalism 

implications.’’ The rule does not ‘‘have 

substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government.’’ 

H. Executive Order 13045 (Protection of 

Children From Environmental Health 

Risks and Safety Risks) 

In accordance with Executive Order 

13045, the Administrator has evaluated 

the environmental health and safety 

effects of this interim final rule on 

children. The Administrator has 

determined that the rule would have no 

environmental health and safety effect 

on children, although an eligible child 

who has been diagnosed with any 

cancer type 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, the Administrator has evaluated 

the effects of this interim final 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 


tkelley on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 79, No. 32 / Tuesday, February 18, 2014 / Rules and Regulations 9117 

1Based on 2005–2009 average annual data ageadjusted to the 2000 U.S. population. See, Copeland 

G, Lake A, Firth R, Wohler B,Wu XC, Stroup A, 

Russell C, Boyuk K, Schymura M, Hofferkamp J, 

Kohler B (eds) [2012]. Cancer in North America: 

2005–2009. Volume One: Combined Cancer 

Incidence for the United States, Canada and North 

America. Springfield, IL: North American 

Association of Central Cancer Registries, Inc. 

the public how to comply with a 

requirement the Federal Government 

administers or enforces. The 

Administrator has attempted to use 

plain language in promulgating the 

interim final rule consistent with the 

Federal Plain Writing Act guidelines 

and requests public comment on this 

effort. 

List of Subjects 

42 CFR Part 88 

Aerodigestive disorders, Appeal 

procedures, Cancer, Health care, Mental 

health conditions, Musculoskeletal 

disorders, Respiratory and pulmonary 

diseases. 

Final Rule 

For the reasons discussed in the 

preamble, the Department of Health and 

Human Services amends 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. 

■ 2. In § 88.1, revise paragraph (4) of the 

definition of ‘‘List of WTC-related 

health conditions’’ to read as follows: 

§ 88.1 Definitions. 

* * * * * 

List of WTC-Related Health 

Conditions * * * 

(4) Cancers: 

(i) Malignant neoplasms of the lip, 

tongue, salivary gland, floor of mouth, 

gum and other mouth, tonsil, 

oropharynx, hypopharynx, and other 

oral cavity and pharynx. 

(ii) Malignant neoplasm of the 

nasopharynx. 

(iii) Malignant neoplasms of the nose, 

nasal cavity, middle ear, and accessory 

sinuses. 

(iv) Malignant neoplasm of the larynx. 

(v) Malignant neoplasm of the 

esophagus. 

(vi) Malignant neoplasm of the 

stomach. 

(vii) Malignant neoplasm of the colon 

and rectum. 

(viii) Malignant neoplasm of the liver 

and intrahepatic bile duct. 

(ix) Malignant neoplasms of the 

retroperitoneum and peritoneum, 

omentum, and mesentery. 

(x) Malignant neoplasms of the 

trachea; bronchus and lung; heart, 

mediastinum and pleura; and other illdefined sites in the respiratory system 

and intrathoracic organs. 

(xi) Mesothelioma. 

(xii) Malignant neoplasms of the 

peripheral nerves and autonomic 

nervous system, and other connective 

and soft tissue. 

(xiii) Malignant neoplasms of the skin 

(melanoma and non-melanoma), 

including scrotal cancer. 

(xiv) Malignant neoplasm of the 

female breast. 

(xv) Malignant neoplasm of the ovary. 

(xvi) Malignant neoplasm of the 

prostate. 

(xvii) Malignant neoplasm of the 

urinary bladder. 

(xviii) Malignant neoplasm of the 

kidney. 

(xix) Malignant neoplasms of the 

renal pelvis, ureter and other urinary 

organs. 

(xx) Malignant neoplasms of the eye 

and orbit. 

(xxi) Malignant neoplasm of the 

thyroid. 

(xxii) Malignant neoplasms of the 

blood and lymphoid tissues (including, 

but not limited to, lymphoma, leukemia, 

and myeloma). 

(xxiii) Childhood cancers: Any type of 

cancer diagnosed in a person less than 

20 years of age. 

(xxiv) Rare cancers: any type of 

cancer 1 that occurs in less than 15 cases 

per 100,000 persons per year in the 

United States. 

* * * * * 

Dated: January 8, 2014. 

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. 2014–03370 Filed 2–14–14; 8:45 am] 

BILLING CODE 4163–18–P 


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