39670 Federal Register / Vol. 78, No. 127 / Tuesday, July 2, 2013 / Proposed Rules 

Based upon EPA’s previous action, 

the 2005 emissions inventory was 

complete and accurate, and met the 

requirement of CAA section 172(c)(3). 

7. Summary of Proposed Actions 

EPA is proposing to determine that 

the Detroit-Ann Arbor area is attaining 

and will continue to attain the 1997 

annual and 2006 24-hour PM2.5

standards. EPA is proposing to approve 

Michigan’s PM2.5 maintenance plan for 

the Detroit-Ann Arbor area as a revision 

to the Michigan SIP because the plan 

meets the requirements of section 175A 

of the CAA. EPA is further proposing 

that the Detroit-Ann Arbor area has met 

the requirements for redesignation 

under section 107(d)(3)(E) of the CAA. 

Therefore, EPA is proposing to grant the 

request from Michigan to change the 

legal designation of the Detroit-Ann 

Arbor area from nonattainment to 

attainment for the 1997 annual and 2006 

24-hour PM2.5 NAAQS. Finally, for 

transportation conformity purposes EPA 

is also proposing to approve Michigan’s 

MVEBs for the Detroit-Ann Arbor area. 

VI. What are the effects of EPA’s 

proposed actions? 

If finalized, approval of the 

redesignation request would change the 

official designation of the Michigan 

portion of the Detroit-Ann Arbor area 

for the 1997 annual and 2006 24-hour 

PM2.5 NAAQS, found at 40 CFR part 81, 

from nonattainment to attainment. If 

finalized, EPA’s proposal would 

approve as a revision to the Michigan 

SIP for the Detroit-Ann Arbor area, the 

maintenance plan for the 1997 annual 

and 2006 24-hour PM2.5 standard. 

VII. Statutory and Executive Order 

Reviews 

Under the CAA, redesignation of an 

area to attainment and the 

accompanying approval of a 

maintenance plan under section 

107(d)(3)(E) are actions that affect the 

status of a geographical area and do not 

impose any additional regulatory 

requirements on sources beyond those 

imposed by state law. A redesignation to 

attainment does not in and of itself 

create any new requirements, but rather 

results in the applicability of 

requirements contained in the CAA for 

areas that have been redesignated to 

attainment. Moreover, the Administrator 

is required to approve a SIP submission 

that complies with the provisions of the 

Act and applicable Federal regulations. 

42 U.S.C. 7410(k); 40 CFR 52.02(a). 

Thus, in reviewing SIP submissions, 

EPA’s role is to approve state choices, 

provided that they meet the criteria of 

the CAA. Accordingly, this action 

merely proposes to approve state law as 

meeting Federal requirements and, if 

finalized, will not impose additional 

requirements beyond those imposed by 

state law. For that reason, these actions: 

• Are not a ‘‘significant regulatory 

action’’ subject to review by the Office 

of Management and Budget under 

Executive Order 12866 (58 FR 51735, 

October 4, 1993); 

• do not impose an information 

collection burden under the provisions 

of the Paperwork Reduction Act (44 

U.S.C. 3501 et seq.); 

• are certified as not having a 

significant economic impact on a 

substantial number of small entities 

under the Regulatory Flexibility Act (5 

U.S.C. 601 et seq.); 

• do not contain any unfunded 

mandate or significantly or uniquely 

affect small governments, as described 

in the Unfunded Mandates Reform Act 

of 1995 (Pub. L. 104–4); 

• do not have Federalism 

implications as specified in Executive 

Order 13132 (64 FR 43255, August 10, 

1999); 

• are not economically significant 

regulatory actions based on health or 

safety risks subject to Executive Order 

13045 (62 FR 19885, April 23, 1997); 

• are not significant regulatory 

actions subject to Executive Order 

13211 (66 FR 28355, May 22, 2001); 

• are not subject to requirements of 

Section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (15 U.S.C. 272 note) because 

application of those requirements would 

be inconsistent with the Clean Air Act; 

and 

• do not provide EPA with the 

discretionary authority to address, as 

appropriate, disproportionate human 

health or environmental effects, using 

practicable and legally permissible 

methods, under Executive Order 12898 

(59 FR 7629, February 16, 1994). 

In addition, this rule does not have 

tribal implications as specified by 

Executive Order 13175 (65 FR 67249, 

November 9, 2000), because the SIP is 

not approved to apply in Indian country 

located in the state, and EPA notes that 

it will not impose substantial direct 

costs on tribal governments or preempt 

tribal law. 

List of Subjects 

40 CFR Part 52 

Environmental protection, Air 

pollution control, Incorporation by 

reference, Intergovernmental relations, 

Particulate matter. 

40 CFR Part 81 

Environmental protection, Air 

pollution control, National parks, 

Wilderness areas. 

Dated: June 19, 2013. 

Susan Hedman, 

Regional Administrator, Region 5. 

[FR Doc. 2013–15887 Filed 7–1–13; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Docket No. CDC–2013–0012] 

42 CFR Part 88 

RIN 0920–AA54 

World Trade Center Health Program; 

Addition of Prostate Cancer to the List 

of WTC-Related Health Conditions 

AGENCY: Centers for Disease Control and 

Prevention, HHS. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: On May 2, 2013, the 

Administrator of the World Trade 

Center (WTC) Health Program received 

a petition (Petition 002) requesting the 

addition of prostate cancer to the List of 

WTC-Related Health Conditions (List) 

covered in the WTC Health Program. 

The Administrator has determined to 

publish a proposed rule adding 

malignant neoplasm of the prostate 

(prostate cancer) to the List in the WTC 

Health Program regulations. 

DATES: Comments must be received by 

August 1, 2013. 

ADDRESSES: Written Comments: You 

may submit comments by any of the 

following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: NIOSH Docket Office, Robert 

A. Taft Laboratories, MS–C34, 4676 

Columbia Parkway, Cincinnati, OH 

45226. 

Instructions: All submissions received 

must include the agency name (Centers 

for Disease Control and Prevention, 

HHS) and docket number (CDC–2013– 

0012) or Regulation Identifier Number 

(0920–AA54) for this rulemaking. All 

relevant comments, including any 

personal information provided, will be 

posted without change to http:// 

www.regulations.gov. For detailed 

instructions on submitting public 

comments, see the ‘‘Public 

Participation’’ heading of the 

SUPPLEMENTARY INFORMATION section of 

this document. 


emcdonald on DSK67QTVN1PROD with PROPOSALS
Federal Register / Vol. 78, No. 127 / Tuesday, July 2, 2013 / Proposed Rules 39671 

1Title 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. 

2Letter dated September 7, 2011 from U.S. 

Senators Charles E. Schumer and Kirsten E. 

Gillibrand, and U.S. Representatives Carolyn B. 

Maloney, Jerrold Nadler, Peter T. King, Charles B. 

Rangel, Nydia M. Vela ́zquez, Michael C. Grimm and 

Yvette D. Clarke to John Howard, M.D. 

3See PHS Act, sec. 3312(a)(6)(B)(i); 42 CFR 

88.17(a)(2)(i). 

Docket: For access to the docket to 

read background documents, go to 

http://www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: Paul 

Middendorf, Senior Health Scientist, 

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

GA 30329; telephone (404) 498–2500 

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

pmiddendorf@cdc.gov. 

SUPPLEMENTARY INFORMATION: 

This notice is organized as follows: 

I. Executive Summary 

A. Purpose of Regulatory Action 

B. Summary of Major Provisions 

C. Costs and Benefits 

II. Public Participation 

III. Background 

A. WTC Health Program Statutory 

Authority 

B. Rulemaking History 

C. Methods Used by the Administrator To 

Determine Whether To Add Cancer or 

Types of Cancer to the List of WTCRelated Health Conditions 

D. Consideration of Prostate Cancer, 2011– 

2012 

1. First Periodic Review of the Scientific 

and Medical Evidence Related to Cancer, 

July 2011 

2. Rulemaking in Response to Petition 001 

E. Petition 002 

IV. Administrator’s Determination on 

Petition 002 Requesting the Addition of 

Prostate Cancer to the List 

V. Early Detection of Prostate Cancer 

VI. Effects of Rulemaking on Federal 

Agencies 

VII. Summary of Proposed Rule 

VIII. Regulatory Assessment Requirements 

A. Executive Order 12866 and Executive 

Order 13563 

B. Regulatory Flexibility Act 

C. Paperwork Reduction Act 

D. Small Business Regulatory Enforcement 

Fairness Act 

E. Unfunded Mandates Reform Act of 1995 

F. Executive Order 12988 (Civil Justice) 

G. Executive Order 13132 (Federalism) 

H. Executive Order 13045 (Protection of 

Children From Environmental Health 

Risks and Safety Risks) 

I. Executive Order 13211 (Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use) 

J. Plain Writing Act of 2010 

I. Executive Summary 

A. Purpose of Regulatory Action 

This rulemaking is being conducted 

in response to a petition to the 

Administrator of the WTC Health 

Program by the Patrolmen’s Benevolent 

Association, a union representing New 

York City police officers (Petition 002). 

The petition asks that the Administrator 

add prostate cancer to the List of WTCRelated Health Conditions. 

B. Summary of Major Provisions 

The rule proposes the addition of 

prostate cancer to the cancers identified 

in 42 CFR 88.1, Table 1 as covered by 

the WTC Health Program for treatment 

and monitoring. 

C. Costs and Benefits 

The proposed addition of prostate 

cancer by this rulemaking is estimated 

to cost the WTC Health Program 

between $3,462,675 and $6,995,817 per 

annum. All of the costs to the WTC 

Health Program will be transfers after 

the implementation of provisions of the 

Patient Protection and Affordable Care 

Act (Pub. L. 111–148) on January 1, 

2014. 

II. Public Participation 

Interested persons or organizations 

are invited to participate in this 

rulemaking by submitting written views, 

opinions, recommendations, and/or 

data. Comments are invited on any topic 

related to this proposed rule. 

Comments received, including 

attachments and other supporting 

materials, are part of the public record 

and subject to public disclosure. Do not 

include any information in your 

comment or supporting materials that 

you consider confidential or 

inappropriate for public disclosure. 

Comments submitted electronically or 

by mail should be titled ‘‘Docket No. 

CDC–2013–0012’’ and should identify 

the author(s) and contact information in 

case clarification is needed. Electronic 

and written comments can be submitted 

to the addresses provided in the 

ADDRESSES section, above. All 

communications received on or before 

the closing date for comments will be 

fully considered by the Administrator of 

the WTC Health Program. 

III. Background 

A. WTC Health Program Statutory 

Authority 

Title I of the James Zadroga 9/11 

Health and Compensation Act of 2010 

(Pub. L. 111–347), amended the Public 

Health Service Act (PHS Act) to add 

Title XXXIII 1 establishing the WTC 

Health Program within the Department 

of Health and Human Services (HHS). 

The WTC Health Program provides 

medical monitoring and treatment 

benefits to eligible firefighters and 

related personnel, law enforcement 

officers, and rescue, recovery, and 

cleanup workers (responders) who 

responded to the September 11, 2001, 

terrorist attacks in New York City, at the 

Pentagon, and in Shanksville, 

Pennsylvania, and to eligible persons 

(survivors) who were present in the dust 

or dust cloud on September 11, 2001 or 

who worked, resided, or attended 

school, childcare, or adult daycare in 

the New York City disaster area. 

All references to the Administrator of 

the WTC Health Program 

(Administrator) in this notice mean the 

Director of the National Institute for 

Occupational Safety and Health 

(NIOSH) or his or her designee. Section 

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

Administrator to conduct rulemaking to 

propose the addition of a health 

condition to the List of WTC-Related 

Health Conditions (List) codified in 42 

CFR 88.1. 

B. Rulemaking History 

On September 7, 2011, the 

Administrator received a written 

petition to add a health condition to the 

List in § 88.1 (Petition 001). Petition 001 

requested that the Administrator 

‘‘conduct an immediate review of new 

medical evidence showing increased 

cancer rates among firefighters who 

served at ground zero and that [the 

Administrator] consider adding 

coverage for cancer under the Zadroga 

Act.’’ 2

Pursuant to section 3312(a)(6)(B) of 

the PHS Act, interested parties may 

petition to add a health condition to the 

List. Within 60 calendar days after 

receipt of a petition to add a condition 

to the List, the Administrator must take 

one of the following four actions 

described in 42 CFR 88.17: (i) Request 

a recommendation of the WTC Health 

Program Scientific/Technical Advisory 

Committee (STAC); (ii) publish a 

proposed rule in the Federal Register to 

add such health condition; (iii) publish 

in the Federal Register the 

Administrator’s determination not to 

publish such a proposed rule and the 

basis for such determination; or (iv) 

publish in the Federal Register a 

determination that insufficient evidence 

exists to take action under (i) through 

(iii) above. 

On October 5, 2011, the Administrator 

formally exercised his option to request 

a recommendation from the STAC 

regarding Petition 001.3 In a letter to the 

STAC the Administrator requested ‘‘that 

the STAC review the available 

information on cancer outcomes 

associated with the exposures resulting 


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4Letter dated October 5, 2011 from John Howard, 

M.D. to Elizabeth Ward, Ph.D., STAC Chair 

available at http://www.cdc.gov/niosh/docket/ 

archive/pdfs/NIOSH-248/0248-100511-letter.pdf. 

Accessed June 1, 2013. 

5On October 12, 2012, HHS published a Federal 

Register notice to correct errors in Table 1 of the 

final rule (the list of cancers covered by the 

Program) (77 FR 62167). 

6 77 FR 56138, 56142. 

7The results of epidemiologic studies are the 

primary and best evidence for making a 

determination of a causal association between an 

exposure and a health outcome, such as cancer. An 

analysis of the results of any epidemiologic study 

has three possible outcomes: (1) The analysis 

supports an association between exposures and a 

health outcome (yes); (2) the analysis supports that 

there is no association between exposures and a 

health outcome (no); or (3) the analysis is 

inconclusive about whether an association exists 

between exposures and a health outcome 

(inconclusive). 

8National Toxicology Program (NTP), U.S. 

Department of Health and Human Services. Report 

on Carcinogens (RoC). http://ntp.niehs.nih.gov/

?objectid=72016262-BDB7-CEBA-FA60E922

B18C2540. Accessed May 15, 2013. 

9World Health Organization International Agency 

for Research on Cancer (IARC). http:// 

monographs.iarc.fr/. Accessed May 15, 2013. 

10First Periodic Review of Scientific and Medical 

Evidence Related to Cancer for the World Trade 

Center Health Program, VI.C, p. 40. 

from the September 11, 2001, terrorist 

attacks, and provide advice on whether 

to add cancer, or a certain type of 

cancer, to the List specified in the 

Zadroga Act.’’ 4

In response to the Administrator’s 

request, the STAC submitted its 

recommendation on April 2, 2012. After 

considering the STAC’s 

recommendation, the Administrator 

issued a notice of proposed rulemaking 

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

September 12, 2012, the Administrator 

published a final rule in the Federal 

Register adding over 50 types of cancer 

to the List of WTC-Related Health 

Conditions in 42 CFR 88.1 (77 FR 

56138).5

C. Methods Used by the Administrator 

To Determine Whether To Add Cancer 

or Types of Cancer to the List of WTCRelated Health Conditions 

In the final rule published September 

12, 2012, the Administrator established 

a four-part hierarchical methodology to 

apply in evaluating whether to propose 

adding certain types of cancer to the List 

of WTC-Related Health Conditions 

included in 42 CFR 88.1.6 Method 1 is 

the preferred method for adding types of 

cancer to the List. When the analysis of 

epidemiologic studies in Method 1 does 

not support a causal association 

between 9/11 exposures and a type of 

cancer, the Administrator applies the 

criteria of Method 2.7 If no causal 

association between a currently listed 

condition and the type of cancer is 

identified using Method 2, the 

Administrator applies the criteria of 

Method 3. If Method 3 does not indicate 

that a recognized 9/11 exposure is 

categorized by the National Toxicology 

Program (NTP) as a known or 

reasonably anticipated human 

carcinogen 8 or the International Agency 

for Research on Cancer (IARC) has not 

determined there is sufficient or limited 

evidence in humans that a 9/11 

exposure is causally associated with a 

type of cancer,9 then the criteria of 

Method 4 are applied. Under Method 4, 

the Administrator determines whether 

the STAC has provided a reasonable 

basis for adding the type of cancer, aside 

from Methods 1, 2, or 3. Only where the 

Administrator is satisfied that one of the 

four methods provides a reasonable 

basis to add the cancer will he propose 

that a type of cancer be added to the 

List. The four methods are presented in 

detail below: 

Method 1. Epidemiologic Studies of 

September 11, 2001 Exposed Populations. A 

type of cancer may be added to the List if 

published, peer-reviewed epidemiologic 

evidence supports a causal association 

between 9/11 exposures and a type of cancer. 

The following criteria extrapolated from the 

Bradford Hill criteria will be used to evaluate 

the evidence of the exposure-cancer 

relationship: 

Strength of the association between a 9/11 

exposure and a health effect (including the 

magnitude of the effect and statistical 

significance); 

b Consistency of the findings across 

multiple studies; 

b Biological gradient, or dose (or 

exposure)-response relationships between 

9/11 exposures and the cancer type; and 

b Plausibility and coherence with known 

facts about the biology of the cancer type. 

If only a single published epidemiologic 

study is available for review, the consistency 

of findings cannot be evaluated and strength 

of association will necessarily place greater 

emphasis on statistical significance than on 

the magnitude of the effect. 

Method 2. Established Causal Associations. 

A type of cancer may be added to the List 

if there is well-established scientific support 

published in multiple epidemiologic studies 

for a causal association between that cancer 

and a condition already on the List of WTCRelated Health Conditions. 

Method 3. Review of Evaluations of 

Carcinogenicity in Humans. A type of cancer 

may be added to the List only if both of the 

following criteria for Method 3 are satisfied: 

b 3A. Published Exposure Assessment 

Information. 9/11 exposures were reported in 

a published, peer-reviewed exposure 

assessment study of responders or survivors 

who were present in either the New York 

City disaster area as defined in 42 CFR 88.1, 

or at the Pentagon, or in Shanksville, 

Pennsylvania; and 

b 3B. Evaluation of Carcinogenicity in 

Humans from Scientific Studies. NTP has 

determined that any of the 9/11 exposures 

are known to be a human carcinogen or is 

reasonably anticipated to be a human 

carcinogen, and IARC has determined there 

is sufficient or limited evidence that the 

9/11 exposure causes a type of cancer. 

Method 4. Review of Information Provided 

by the WTC Health Program Scientific/ 

Technical Advisory Committee. A type of 

cancer may be added to the List if the STAC 

has provided a reasonable basis, for adding 

a type of cancer, and the basis for inclusion 

does not meet the criteria for Methods 1, 2, 

or 3. 

D. Consideration of Prostate Cancer, 

2011–2012 

Since 2011, the Administrator has 

twice evaluated whether to add health 

conditions to the List. In both instances, 

the Administrator considered adding 

certain types of cancer to the List, 

including prostate cancer. 

1. First Periodic Review of the Scientific 

and Medical Evidence Related to 

Cancer, July 2011 

The Administrator’s first evaluation 

was published in the July 2011 First 

Periodic Review of the Scientific and 

Medical Evidence Related to Cancer 

(First Periodic Review) for the WTC 

Health Program. As required by Title 

XXXIII, section 3312(a)(5)(A) of the PHS 

Act, the Administrator reviewed ‘‘all 

available scientific and medical 

evidence, including findings and 

recommendations of Clinical Centers of 

Excellence, published in peer-reviewed 

journals to determine if, based on such 

evidence, cancer or a certain type of 

cancer should be added to the 

applicable list of WTC-related health 

conditions.’’ The Administrator used a 

‘‘weight of the evidence’’ approach to 

evaluate the available data. At that time, 

there were no significant epidemiologic 

studies available which evaluated the 

association of 9/11 exposures and health 

outcomes involving types of cancer. As 

a result, the Administrator determined 

that insufficient evidence existed at that 

time to propose the addition of cancer, 

or certain types of cancer, to the List, 

but cautioned that, 

the current absence of published scientific 

and medical findings demonstrating a causal 

association between exposures resulting from 

the September 11, 2001, terrorist attacks and 

the occurrence of cancer in responders and 

survivors does not indicate evidence of the 

absence of a causal association.10

2. Rulemaking in Response to Petition 

001 

The Administrator’s second 

evaluation of whether to add cancer or 

certain types of cancer to the List 

followed receipt of Petition 001 and the 

subsequent recommendation on the 


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11Zeig-Owens R, Webber MP, Hall CB, Schwartz 

T, Jaber N, Weakley J, Rohan TE, Cohen HW, 

Derman O, Aldrich TK, Kelly K, Prezant DJ [2011]. 

Early Assessment of Cancer Outcomes in New York 

City Firefighters After the 9/11 Attacks: An 

Observational Cohort Study. Lancet. 378(9794):898– 

905. 

12NTP (National Toxicology Program) [2011]. 

12th Report on Carcinogens. National Toxicology 

Program, Public Health Service, U.S. Department of 

Health and Human Services, Research Triangle 

Park, NC. http://ntp.niehs.nih.gov/ 

?objectid=03C9AF75-E1BF-FF40- 

DBA9EC0928DF8B15. Accessed May 24, 2013. 

13 IARC (International Agency for Research on 

Cancer) [2012]. IARC Monographs on the 

Evaluation of the Carcinogenic Risks to Humans: 

Vol. 100C—Arsenic, Metals, Fibres, and Dusts. 

IARC, Lyon, France. http://monographs.iarc.fr/ 

ENG/Monographs/vol100C/index.php. Accessed 

May 24, 2013. 

14STAC (WTC Health Program Scientific/ 

Technical Advisory Committee) [2012]. Transcript 

of the STAC meeting, March 28, 2012:97–105. 

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

NIOSH-248/0248-032812-transcript3.pdf. Accessed 

June 1, 2013. 

15The PSA test was approved by the Food and 

Drug Administration in 1986 for the purpose of 

monitoring disease status in prostate cancer, and in 

1994 for the detection of prostate cancer in men 50 

years and older. The routine use of the PSA test for 

screening increased dramatically beginning in 1998, 

along with the prostate cancer incidence, but the 

incidence has since fallen. See Etzioni R, Penson 

DF, Legler JM, di Tommaso D, Boer R, Gann PH, 

Feuer EJ. (2002) Overdiagnosis due to prostatespecific antigen screening: lessons from U.S. 

prostate cancer incidence. JNCI 94(13):981–990; 

Potosky AL, Miller BA, Albertsen PC, Kramer BS. 

(1995) The role of increasing detection in the rising 

incidence of prostate cancer. JAMA 273:548–552; 

and Altekruse SF, Kosary C, Krapcho M et al. (2010) 

SEER cancer statistics review 1975–2007. Bethesda, 

MD: National Cancer Institute. http:// 

seer.cancer.gov/csr/1975_2007/. Accessed June 2, 

2013. 

16See STAC (WTC Health Program Scientific/ 

Technical Advisory Committee) [2012]. Transcript 

of the STAC meeting, March 28, 2012:98, lines 23– 

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

NIOSH-248/0248-032812-transcript3.pdf. Accessed 

June 1, 2013. 

17STAC (WTC Health Program Scientific/ 

Technical Advisory Committee) [2012]. Letter from 

Elizabeth Ward, Chair to John Howard, MD, 

Administrator at 24. This letter is included in the 

docket for this rulemaking. 

18Solan 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. 

Petition from the STAC. During 

meetings held November 9–10, 2011, 

February 15–16, 2012, and March 28, 

2012, the STAC reviewed the available 

scientific evidence for adding cancer or 

certain types of cancer to the List and 

made its recommendation to the 

Administrator regarding Petition 001 on 

April 2, 2012. 

In reviewing Petition 001, the STAC 

compiled and reviewed the available 

evidence for adding all types of cancer, 

including prostate cancer, to the List. 

Specifically, with regard to the analysis 

of prostate cancer, this evidence 

included (1) the results of a study by 

Zeig-Owens et al., published in The 

Lancet in September 2011; 11 and (2) a 

determination by NTP that arsenic and 

cadmium, 9/11 exposures, are known to 

be human carcinogens 12 and a 

determination by IARC that limited 

evidence supports a causal association 

between prostate cancer and arsenic or 

cadmium exposure.13

At the March 28, 2012 meeting, STAC 

members noted that prostate cancer 

would qualify for inclusion in its 

recommendation of types of cancer that 

should be added to the List based on 

evidence from NTP and IARC.14

However, other STAC members 

expressed concern that the increased 

rate of prostate cancer in both exposed 

and unexposed firefighters in the ZeigOwens study was a result of 

surveillance bias associated with 

widespread screening for prostate 

cancer. The Zeig-Owens study involved 

a small population that was subject to 

substantial medical screening. STAC 

members expressed concern that the 

observed excess risk for prostate cancer 

seen in the Zeig-Owens study was the 

result of screening for prostate cancer by 

means of the prostate-specific antigen 

(PSA) test.15

During the meeting, the STAC 

considered a motion to ‘‘recommend 

adding prostate cancer to the list of 

covered conditions.’’ 16 The motion 

failed in an 8 to 7 vote. In the April 2, 

2012 recommendation, the STAC noted 

that ‘‘the WTC-exposed FDNY [Fire 

Department of New York] group did not 

show an increased risk over the 

unexposed, with estimated SIR 

[standardized incidence ratio] ratio [of] 

0.90 (after correction for possible 

surveillance bias),’’ and concluded 

‘‘therefore, despite the statistically 

significant SIR for prostate cancer in 

WTC-exposed firefighters compared to 

the general population, the overall 

results do not support an increased risk 

of prostate cancer associated with WTC 

exposures.’’ 17 The STAC’s discussion 

and subsequent vote indicated that the 

members found that the epidemiologic 

evidence of 9/11-exposed populations 

outweighed the NTP and IARC evidence 

of carcinogenicity of arsenic and 

cadmium. 

In evaluating whether to add prostate 

cancer based on Method 1, the 

Administrator considered the STAC’s 

concerns about the findings of the one 

epidemiologic study that was available 

to review at the time, the Zeig-Owens 

study, which involved a small, heavily 

medically screened population. The 

Administrator agreed that surveillance 

bias could have explained the excess 

prostate cancer risk found in the study. 

In addition, as the STAC noted—and the 

Administrator agreed—the SIR for 

prostate cancer fell to 0.90 after 

correction for surveillance bias. The 

Administrator determined that, based 

on the information then available, the 

prostate cancer risk was not 

significantly increased over an 

appropriate reference population 

(Method 1). Additionally, no evidence 

existed for a causal association between 

prostate cancer and a condition already 

on the List (Method 2). 

As described above, the basis for 

adding a cancer according to the criteria 

in Method 3 is a determination by NTP 

that 9/11 exposures are known or 

reasonably anticipated to be human 

carcinogens, and a determination by 

IARC that sufficient or limited evidence 

in humans supports a causal association 

between a cancer and a 9/11 exposure. 

The STAC considered the 

determinations by NTP and IARC 

regarding the carcinogenicity of arsenic 

and cadmium and still voted not to 

recommend adding prostate cancer to 

the List. The Administrator was aware 

that two additional epidemiologic 

studies in 9/11-exposed populations 

were then in progress and might provide 

additional information about the 

association of prostate cancer and 9/11 

exposures in the future. Given the 

STAC’s decision not to recommend the 

addition of prostate cancer, which relied 

on the epidemiologic evidence available 

at that time, the Administrator 

determined that there was not a 

reasonable basis for adding prostate 

cancer to the List. 

E. Petition 002 

On May 2, 2013, the Administrator 

received Petition 002 from the 

Patrolmen’s Benevolent Association, a 

union representing New York City 

police officers. Petition 002 references, 

and relies upon, a study of over 25,000 

WTC responders enrolled in the WTC 

Health Program, authored by Solan et al. 

and published in the scientific journal 

Environmental Health Perspectives.18

Petition 002 asserts that the Solan study: 

[A]ffirms what was reported in prior 

published studies, that those exposed to the 

Ground Zero toxins are at higher risk of 

developing cancer than the general 

population. Notably, the Study found a 

statistically significant incidence rate for 

prostate cancer, including a 17% greater than 

expected rate of prostate cancer among 

responders. According to the Study, these 

findings were ‘‘concordant’’ with the findings 

of the New York City Fire Department 


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19The Petitioner incorrectly states that the Solan 

study reported a 17 percent increase in prostate 

cancer. Solan et al. report a 21 percent increase in 

prostate cancer when the timeframe for diagnosis is 

unrestricted, and 23 percent when the timeframe for 

diagnosis is restricted. 

20Li J, Cone JE, Kahn AR, Brackbill RM, Farfel 

MR, Greene CM, Hadler JL, Stayner LT, Stellman 

SD [2012]. Association Between World Trade 

Center Exposure and Excess Cancer Risk. JAMA 

308(23):2479–2488. 

21Zeig-Owens et al. 2011. 

22 If the observed number of cancer cases equals 

the expected number of cases, the SIR equals 1 

(one). If more cases are observed in the studied 

population than expected, the SIR is greater than 1 

(one). If fewer cases are observed in the studied 

population than expected, the SIR is less than 1. 

23 If the SIR in the studied population equals the 

SIR in the reference population, the SIR ratio equals 

1 (one). If the SIR in the studied population is 

greater than the SIR in the reference population, the 

SIR ratio is greater than 1 (one). If the SIR ratio in 

the studied population is less than the SIR in the 

reference population, the SIR ratio is less than 1 

(one). 24Li et al., 2012. 

[FDNY] and the New York City Department 

of Health and Mental Hygiene World Trade 

Center Health City Registry.19

The ‘‘prior published studies’’ 

referenced in Petition 002 were 

authored by Zeig-Owens et al., and by 

Li et al., published in the Journal of the 

American Medical Association (JAMA) 

in December 2012.20 The Zeig-Owens, 

Li, and Solan studies are reviewed and 

analyzed by the Administrator below. In 

reviewing Petition 002, the 

Administrator is mindful of what the 

STAC stated in its April 2, 2012 

recommendation to the Administrator: 

The Committee recognizes that additional 

epidemiologic studies will soon become 

available, and recommends that as they do 

become available, their findings be reviewed 

and modifications made to the list as 

appropriate. 

Accordingly, the Administrator 

reviewed the two new epidemiologic 

studies in 9/11 exposed populations 

published subsequent to the 2011 ZeigOwens study. The Administrator’s 

review focused on the information that 

the three epidemiologic studies, taken 

as a whole, provided on the question of 

the risk of prostate cancer in association 

with 9/11 exposures and the role of 

surveillance bias in explaining any 

observed excess risk. The 

Administrator’s findings regarding the 

three studies are described below, under 

Method 1. 

IV. Administrator’s Determination on 

Petition 002 Requesting the Addition of 

Prostate Cancer to the List 

In response to Petition 002, the 

Administrator has reviewed the 

available evidence pertinent to the fourpart hierarchical methodology detailed 

above. The Administrator’s review of 

the relevant evidence is below. 

Method 1 

Method 1 requires that the 

Administrator evaluate the available 

information in published, peer-reviewed 

epidemiologic studies for evidence of an 

adequate strength of the association 

between 9/11 exposure and a health 

effect (including the magnitude of the 

effect and its statistical significance), 

consistency of the findings across 

multiple studies, biological gradient, or 

dose (or exposure)-response 

relationships between 9/11 exposures 

and the cancer type, and plausibility 

and coherence with known facts about 

the biology of the cancer type. 

The Zeig-Owens study. The first 

published study of cancer outcomes 

associated with the 9/11 attacks was 

authored by Zeig-Owens et al. and 

published in September 2011. The study 

involved examination of the potential 

association between exposure and 

cancer outcomes among 9,853 male Fire 

Department of the City of New York 

(FDNY) firefighters within 7 years of 

September 11, 2001.21 The study 

evaluated cancer cases identified by 

self-reporting and through five state 

cancer registries. SIRs were used to 

determine if the number of observed 

cancer cases in the studied firefighters 

was greater or less than the number of 

cases expected to occur if the same 

disease rate in a large reference 

population occurred in the studied 

group.22 The reference cancer incidence 

data was obtained from the U.S. 

National Cancer Institute Surveillance 

Epidemiology and End Results (SEER) 

database. 

In the Zeig-Owens study, the SIRs for 

various types of cancer, including 

prostate cancer, were reported in two 

ways: (1) By comparing the exposed 

FDNY firefighters to the general 

population; and (2) by comparing the 

SIR for 9/11 exposed FDNY firefighters 

to the SIR for non-9/11 exposed FDNY 

firefighters (the ratio of standardized 

incidence ratios is referred to as the 

‘‘SIR ratio’’). When compared to the 

general population, the SIR for prostate 

cancer was increased, and that increase 

was statistically significant (SIR=1.49, 

95% confidence interval (CI) 1.20–1.85). 

When compared to non-9/11 exposed 

FDNY firefighters, the SIR ratio was 

slightly greater than 1 (one),23 but the 

increase was not statistically significant 

(SIR ratio=1.11, 95% CI 0.77–1.59). 

Zeig-Owens noted the potential for 

surveillance bias, that is, FDNY 

firefighters may be medically followed 

more closely or have more diagnostic 

tests performed than the general 

population, which could lead to finding 

more disease among this population. 

A standard method to adjust for 

surveillance bias is not available, and 

the adequacy of any adjustment method 

is uncertain. In an attempt to correct for 

surveillance bias, Zeig-Owens adjusted 

the SIRs and SIR ratios by delaying the 

recorded date of diagnosis by 2 years for 

25 cases of prostate and other cancers 

that potentially could be detected early 

by FDNY surveillance (i.e., medical 

screening). When the estimates were 

adjusted in this way, the comparison to 

the general population produced a SIR 

for prostate cancer that was increased, 

but not statistically significant 

(SIR=1.21, 95% CI 0.96–1.52). When 

compared to non-exposed firefighters, 

the SIR ratio was not increased (SIR 

ratio=0.90, 95% CI 0.62–1.30). The 

authors noted that they had gone to 

‘‘great lengths’’ to assess and correct for 

potential biases and provided arguments 

against the existence of considerable 

bias. However, the authors further noted 

that delaying the date of diagnosis may 

have over-corrected or under-corrected 

for surveillance bias, and the authors 

could not rule out the potential for 

surveillance bias in several types of 

cancer, including prostate cancer. 

The Li study. Li et al. authored the 

second published epidemiologic study 

of cancer outcomes associated with the 

9/11 attacks, published in December 

2012. It involved examination of cancer 

health outcomes of 55,778 members of 

the WTC Health Registry, including 

rescue and recovery workers as well as 

people not involved in rescue and 

recovery (e.g., area residents, workers, 

and passersby).24 In comparison to the 

Zeig-Owens study, the Li study involves 

a much larger and more heterogeneous 

population that is likely subjected to 

much less medical screening and 

surveillance bias. 

In the Li study, cancer cases were 

identified through 11 state cancer 

registries; New York State cancer rates 

were used as the reference. The authors 

accounted for cancer latency by 

assuming that any exposure-related 

cancers would be more likely to occur 

at least 5 years after the 9/11 exposures. 

The study population was divided into 

two groups: Early period (WTC Health 

Registry participants who were 

diagnosed with cancer between 

enrollment and 2006) and later period 

(WTC Health Registry participants who 

were diagnosed with cancer between 

2007 and 2008). Among rescue and 

recovery workers, a statistically 

significant increase in the incidence of 

prostate cancer was reported for the 


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25A type 1 error is a ‘‘false positive.’’ In this case, 

the authors are noting that they made a large 

number of comparisons in the study and, when 

making a large number of comparisons, it is likely 

that some statistically significant findings will 

occur by chance. 

26Li et al., at 2486. 

27Solan et al., 2013. 

28Solan et al., at 702. 

29Selection bias might have occurred when 

individuals decided to enroll in the WTC Health 

Program after being diagnosed with prostate cancer. 

If this occurred, the number of prostate cancers 

among the exposed population would be increased 

and result in a higher SIR. 

30Butt CM, Diamond ML, Truong J, Ikonomou 

MG, Helm PA, Stern GA [2004]. Semivolatile 

organic compounds in window films from lower 

Manhattan after the September 11th World Trade 

Center attacks. Environmental Science & 

Technology. 38(13):3514–3524. 

Lorber M, Gibb H, Grant L, Pinto J, Pleil J, 

Cleverly D [2007]. Assessment of inhalation 

exposures and potential health risks to the general 

population that resulted from the collapse of the 

World Trade Center towers. Risk Anal 27(5):1203– 

21. 

Lioy PJ, Gochfeld M [2002]. Lessons learned on 

environmental, occupational, and residential 

exposures from the attack on the World Trade 

Center. Am J Ind Med 42(6):560–565. 

31NTP (National Toxicology Program) [2011]. 

12th Report on Carcinogens. National Toxicology 

Program, Public Health Service, U.S. Department of 

Health and Human Services, Research Triangle 

Park, NC. http://ntp.niehs.nih.gov/ 

?objectid=03C9AF75-E1BF-FF40- 

DBA9EC0928DF8B15. Accessed May 24, 2013. 

32 IARC (International Agency for Research on 

Cancer) [2012]. IARC Monographs on the 

Evaluation of the Carcinogenic Risks to Humans: 

Vol. 100C—Arsenic, Metals, Fibres, and Dusts. 

IARC, Lyon, France. http://monographs.iarc.fr/ 

ENG/Monographs/vol100C/index.php. Accessed 

May 24, 2013. 

later period (SIR=1.43, 95% CI 1.11– 

1.82). In the early period, the SIR was 

slightly, but not statistically 

significantly, increased (SIR=1.12, 95% 

CI 0.83–1.40). 

The potential for surveillance bias in 

the Li study was assessed by: (1) 

Comparing the number of Stage 1 

cancers for selected cancer sites as a 

proportion of total cancer diagnoses in 

the study population to the 

corresponding proportion in the New 

York State reference population during 

the same period; and (2) comparing the 

proportion of participants who reported 

a routine physical checkup within the 

preceding 12 months to the number of 

follow-up participants with and without 

subsequent cancers. Importantly, the Li 

study noted that the proportions were 

similar in both cases and stated: 

These observations suggest that cancer 

cases in this study may not have received 

more thorough cancer screening than the 

NYS [New York State] population in general, 

although they do not eliminate the possible 

role of surveillance altogether. Also, our 

findings might be prone to type 1 error 25

given the large number of comparisons.26

The Solan study. The third 

epidemiologic study of cancer outcomes 

in 9/11 exposed populations was 

authored by Solan et al. First published 

online in April 2013 and then in print 

in June of 2013, this study addressed 

cancer health outcomes associated with 

the 9/11 attacks involving 20,984 WTC 

responders (including rescue and 

recovery workers) enrolled in the WTC 

Health Program.27 Cancer cases 

diagnosed between 2001 and 2008 were 

identified through the New York, New 

Jersey, Connecticut, and Pennsylvania 

cancer registries, and SIRs were 

calculated using the general population 

of the state of residence as the reference 

population. No adjustments were made 

for potential surveillance bias. When all 

prostate cancers diagnosed after 

September 11, 2001 were included, a 

small statistically significant increase in 

the SIR for prostate cancer among WTC 

responders was observed (SIR = 1.21, 

95% CI 1.01–1.44). The authors note 

that, ‘‘[e]vidence for occupational risk 

factors of prostate cancer is very weak, 

and heightened diagnosis due to 

increased medical surveillance is a 

possible explanation for greater than 

expected numbers of prostate cancer 

diagnoses.’’ 28 The SIR was also 

calculated for those WTC responders 

who were diagnosed with prostate 

cancer 6 months after enrollment in the 

WTC Health Program. This adjustment 

reduces the potential for selection 

bias 29 in the results. After this 

adjustment, the SIR for prostate cancer 

remained increased, but was not 

statistically significant (SIR = 1.23, 95% 

CI 0.98–1.53). 

When more than one epidemiologic 

study in 9/11 exposed populations has 

been published, Method 1 directs the 

Administrator to evaluate findings from 

the studies using the following criteria: 

(1) Strength of any association between 

a 9/11 exposure and a health effect 

(including the magnitude of the effect 

and statistical significance); (2) 

consistency of the findings across 

multiple studies; (3) biological gradient 

or dose-response relationships between 

9/11 exposures and the cancer type; and 

(4) the plausibility and coherence with 

known facts about the biology of the 

cancer type. After review, the 

Administrator finds that the strength of 

the association between 9/11 exposures 

and prostate cancer across all three 

studies is weak (criteria 1), but that 

excess risk is consistently reported in 

each of the three studies (criteria 2). A 

dose (exposure)-response relationship 

between 9/11 exposures and prostate 

cancer is difficult to establish because of 

the substantial limitations of 9/11 

exposure information (criteria 3). 

Finally, there is limited evidence of the 

potential plausibility of the 

development of prostate cancer with 

two of the documented 9/11 

exposures—arsenic and cadmium 

(criteria 4). The Li study provides 

evidence that surveillance bias does not 

fully explain the observed excess risk 

for prostate cancer. 

Because surveillance bias may not 

explain all of the observed excess risk 

in studies of 9/11-exposed populations 

and because the strength of the 

association between 9/11 exposures and 

prostate cancer across all three studies 

is weak, the Administrator has 

determined that the evidence to add 

prostate cancer based on Method 1 is 

inconclusive. 

Method 2 

Method 2 requires that the 

Administrator find that multiple 

epidemiologic studies show a causal 

association between a type of cancer 

and a health condition already on the 

List of WTC-Related Health Conditions. 

After review of the scientific literature, 

the Administrator finds that there is no 

evidence that any of the conditions on 

the List of WTC-Related Health 

Conditions increase the risk of prostate 

cancer and Method 3 should be 

reviewed. 

Method 3 

Method 1 provides insufficient 

evidence to add prostate cancer to the 

List and Method 2 provides no evidence 

to add prostate cancer. The 

Administrator next reviewed 9/11 

exposures in relation to NTP and IARC 

information pertinent to prostate cancer 

(Method 3). 

Arsenic and cadmium are 9/11 

exposures that have been reported in 

several exposure assessment studies of 

responders or survivors of the 

September 11, 2001, terrorist attacks in 

New York City (Method 3A); 30 and NTP 

identified arsenic and cadmium as 

known to be human carcinogens 31 and 

IARC found limited 32 evidence in 

humans that arsenic and cadmium 

cause prostate cancer (Method 3B). 

Based on the evidence provided in 

Methods 3A and 3B, the Administrator 

has determined that prostate cancer 

should be added to the List. 

Method 4 

Because Method 3 supports the 

addition of prostate cancer, Method 4 is 

not analyzed. 

Administrator’s Determination 

Following review of all relevant 

evidence, the Administrator has 


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33U.S. Preventive Services Task Force. 

Recommendation: Screening for Prostate Cancer 

(2012). http:// 

www.uspreventiveservicestaskforce.org/ 

prostatecancerscreening.htm. Accessed June 2, 

2013. 

34 ICD–9 code 185 and ICD–10 code C61. See, 

respectively, WHO (World Health Organization) 

[1978]. International Classification of Diseases, 

Ninth Edition, and WHO [1997] International 

Classification of Diseases, Tenth Edition. 

35Based on a population of 60,000 at the U.S. 

cancer rate and discounted at 7 percent. 

36Based on a population of 110,000 at 21 percent 

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

percent. 

37These 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.’’ 

38PHS Act, secs. 3311(a)(4)(A) and 3321(a)(3)(A). 

determined that the decision to not add 

prostate cancer in the 2012 rulemaking 

is superseded by his new evaluation 

incorporating the Li and Solan study 

findings. The 2012 evaluation relied on 

the only epidemiologic study available 

at that time, Zeig-Owens, and the 

STAC’s assessment of that study and 

vote to not include prostate cancer in 

their recommendation. The Li and Solan 

studies present epidemiologic findings 

from larger, more heterogeneous 

populations and present evidence that 

surveillance bias may not be occurring 

in the studied populations. Review of 

the two new studies leads the 

Administrator to believe that 

surveillance bias may not fully explain 

the increased incidence of prostate 

cancer and, accordingly, the 

Administrator can no longer attribute 

increased incidence of prostate cancer 

to surveillance bias with certainty. After 

comprehensive review of all three 

epidemiology studies of 9/11-exposed 

populations, the Administrator has 

determined that the epidemiologic 

evidence evaluated under Method 1 is 

inconclusive and therefore turns to 

evaluating the evidence of 

carcinogenicity provided by NTP and 

IARC under Method 3. The 

Administrator now finds that, based on 

the evidence provided in Methods 3A 

and 3B, prostate cancer may be added 

to the named cancer types in 42 CFR 

88.1, Table 1. 

V. Early Detection of Prostate Cancer 

Early detection of cancer in 9/11- 

exposed populations—either as part of 

medical monitoring of enrolled WTC 

responders and survivors or part of 

ongoing research—is an important 

adjunct to the WTC Health Program. 

The WTC Health Program adheres to the 

recommendations of the U.S. Preventive 

Services Task Force (USPSTF) with 

regard to coverage for preventive 

measures, including screening tests, 

counseling, immunizations, and 

preventive medications. The USPSTF 

recommends against PSA-based 

screening for prostate cancer.33

Therefore, PSA-based screening for 

prostate cancer will not be covered by 

the WTC Health Program. 

VI. Effects of Rulemaking on Federal 

Agencies 

Title II of the James Zadroga 9/11 

Health and Compensation Act of 2010 

(Pub. L. 111–347) reactivated the 

September 11, 2001 Victim 

Compensation Fund (VCF). 

Administered by the U.S. Department of 

Justice (DOJ), the VCF provides 

compensation to any individual or 

representative of a deceased individual 

who was physically injured or killed as 

a result of the September 11, 2001, 

terrorist attacks or during the debris 

removal. Eligibility criteria for 

compensation by the VCF include a list 

of presumptively covered health 

conditions, which are physical injuries 

determined to be WTC-related health 

conditions by the WTC Health Program. 

Pursuant to DOJ regulations, the VCF 

Special Master is required to update the 

list of presumptively covered conditions 

when the List of WTC-Related Health 

Conditions in 42 CFR 88.1 is updated. 

VII. Summary of Proposed Rule 

For the reasons discussed above, the 

Administrator proposes to amend 42 

CFR 88.1, paragraph (4), Table 1, to add 

malignant neoplasm of the prostate 

(prostate cancer) and to add the 

corresponding medical diagnostic 

codes.34

VIII. Regulatory Assessment 

Requirements 

A. Executive Order 12866 and Executive 

Order 13563 

Executive Orders (E.O.) 12866 and 

13563 direct agencies to assess all costs 

and benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects, distributive impacts, and 

equity). E.O. 13563 emphasizes the 

importance of quantifying both costs 

and benefits, of reducing costs, of 

harmonizing rules, and of promoting 

flexibility. 

This notice of proposed rulemaking 

has been determined not to be a 

‘‘significant regulatory action’’ under 

sec. 3(f) of E.O. 12866. The proposed 

addition of prostate cancer by this 

rulemaking is estimated to cost the WTC 

Health Program between $3,462,675 35

and $6,995,817 36 per annum. All of the 

costs to the WTC Health Program will be 

transfers after the implementation of 

provisions of the Patient Protection and 

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

on January 1, 2014. This notice of 

proposed rulemaking has been reviewed 

by the Office of Management and 

Budget (OMB). The rule would not 

interfere with State, local, and Tribal 

governments in the exercise of their 

governmental functions. 

Cost Estimates 

The WTC Health Program has, to date, 

enrolled approximately 58,500 WTC 

responders and approximately 6,500 

survivors, or approximately 65,000 

individuals in total. Of that total 

population, approximately 60,000 

individuals were participants in 

previous WTC medical programs and 

were ‘grandfathered’ into the WTC 

Health Program established by Title 

XXXIII.37 In addition to those 

grandfathered WTC responders and 

survivors already enrolled, the PHS Act 

sets a numerical limitation on the 

number of eligible members who can 

enroll in the WTC Health Program 

beginning July 1, 2011 at 25,000 new 

WTC responders and 25,000 new WTC 

survivors (i.e., the statute restricts new 

enrollment).38 Since July 1, 2011, a total 

of approximately 3,000 new WTC 

responders and new WTC survivors 

(over 1,700 responders and 1,200 

survivors) have enrolled in the WTC 

Health Program, resulting in only a 

minor impact on the statutory 

enrollment limits for new members. For 

the purpose of calculating a baseline 

estimate of cancer prevalence only, the 

Administrator assumed that this gradual 

rate of enrollment would continue, and 

that the currently enrolled population 

numbers would remain around 58,500 

WTC responders and 6,500 WTC 

survivors. The estimate is further based 

on the average U.S. cancer prevalence 

rate and 7 percent discount rate. 

As it is not possible to identify an 

upper bound estimate, HHS has 

modeled another possible point on the 

continuum. For the purpose of 

calculating the impact of an increased 

rate of cancer on the WTC Health 

Program, this analysis assumes that the 

entire statutory cap for new WTC 

responders (25,000) and WTC survivors 

(25,000) will be filled. Accordingly, this 

estimate is based on a population of 

80,000 responders (55,000 

grandfathered + 25,000 new) and 30,000 

survivors (5,000 grandfathered + 25,000 


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39Zeig-Owens R, Webber MP, Hall CB, Schwartz 

T, Jaber N, Weakley J, Rohan TE, Cohen HW, 

Derman O, Aldrich TK, Kelly K, Prezant DJ [2011]. 

Early Assessment of Cancer Outcomes in New York 

City Firefighters After the 9/11 Attacks: An 

Observational Cohort Study. Lancet. 378(9794):898– 

905. 

40Zeig-Owens R, Webber MP, Hall CB, Schwartz 

T, Jaber N, Weakley J, Rohan TE, Cohen HW, 

Derman O, Aldrich TK, Kelly K, Prezant DJ [2011]. 

Early Assessment of Cancer Outcomes in New York 

City Firefighters After the 9/11 Attacks: An 

Observational Cohort Study. Lancet. 378(9794):898– 

905. 

41As Zeig-Owens et al point out, the time interval 

since 9/11 is short for cancer outcomes, the 

recorded excess of cancers is not limited to specific 

sites, and the biological plausibility of chronic 

inflammation as a possible mediator between WTCexposure and cancer means that the outcomes 

remain speculative. 

42 Yabroff KR, Lamont EB, Mariotto A, Warren JL, 

Topor M, Meekins A, Brown ML [2008]. Cost of 

Care for Elderly Cancer Patients in the United 

States. Journal: J Natl Cancer Inst 100(9):630–41. 

43 Yabroff KR, Lamont EB, Mariotto A, Warren JL, 

Topor M, Meekins A, Brown ML [2008]. Cost of 

Care for Elderly Cancer Patients in the United 

States. Journal: J Natl Cancer Inst 100(9):630–41. 

44Surveillance, 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. 

45Bureau of Labor Statistics. Consumer Price 

Index. Available at https://research.stlouisfed.org/ 

fred2/series/CPIMEDSL/downloaddata?cid=32419. 

Accessed April 23, 2012. 

46 Jordan HT, Brackbill RM, Cone JE, 

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

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

Mortality Among Survivors of the Sept 11, 2001, 

Word Trade Center Disaster: Results from the World 

Trade Center Health Registry Cohort. Lancet 

2011;378:879–887. Note: percentages may not sum 

to 100 percent due to rounding. 

new). The upper cost estimate also 

assumes an overall increase in 

population cancer rates (for malignant 

neoplasm of the prostate [prostate 

cancer] of 21 percent due to 9/11 

exposure),39 and costs were discounted 

at 3 percent. The choice of a 21 percent 

increase in the risk of cancer of the rate 

found in the un-exposed population is 

based on findings presented in the first 

published epidemiologic study of 

September 11, 2001 exposed 

populations.40 Given the challenges 

associated with interpreting the ZeigOwens findings,41 we simply 

characterize 21 percent as a possible 

outcome rather than asserting the 

probability that 21 percent is a ‘‘likely’’ 

outcome. 

The Administrator acknowledges that 

some prostate cancer cases are not likely 

to have been caused by 9/11 exposures. 

The certification of individual cancer 

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

of this analysis, the Administrator has 

estimated that all diagnosed cancers 

added to the List will be certified for 

treatment by the WTC Health Program. 

Finally, because there are no existing 

data on cancer rates related to 9/11 

exposures at either the Pentagon or in 

Shanksville, Pennsylvania, the 

Administrator has used only data from 

studies of individuals who were 

responders or survivors in the New York 

City disaster area. 

Costs of Cancer Treatment 

The Administrator estimated the 

treatment costs associated with covering 

prostate cancer in this rulemaking using 

the methods described below. The WTC 

Health Program obtained data for the 

cost of providing medical treatment for 

prostate cancer.42 The costs of treatment 

are described in Table A. The costs of 

treatment are divided into three phases: 

The costs for the first year following 

diagnosis, the costs of intervening years 

or continuing treatment after the first 

year, and the costs of treatment for the 

last year of life. The first year costs of 

cancer treatment are higher due to the 

initial need for aggressive medical (e.g., 

radiation, chemotherapy) and surgical 

care. The costs during last year of life 

are often dominated by increased 

hospitalization costs.43 Therefore, we 

used three different treatment phase 

costs to estimate the costs of treatment 

to be able to best estimate costs in 

conjunction with expected incidence 

and long-term survival rates for prostate 

cancer. 

TABLE A—AVERAGE COSTS OF TREATMENT FOR PROSTATE CANCER

(2011$) 

Initial 

(12 month) 

Continuing 

(annual) 

Last year 

of life 

(12 mos.) 

$13,696 ..... $2,754 $43,481 

These cost figures were based on a 

study of elderly cancer patients from the 

Surveillance, Epidemiology, and End 

Results (SEER) program maintained by 

the National Cancer Institute using 

Medicare files.44 The average costs of 

treatment described above are given in 

2011 prices adjusted using the Medical 

Consumer Price Index for all urban 

consumers.45

Incident Cases of Cancer 

The Administrator estimated the 

expected number of cases of cancer that 

would be observed in a cohort of 

responders and survivors followed for 

cancer incidence after September 11, 

2001 using U.S. population cancer rates 

for prostate cancer. Demographic 

characteristics of the cohort were 

assigned since the actual data are not 

available for individuals in the 

responder and survivor populations 

who have not yet enrolled in the WTC 

Health Program. Gender and age (at the 

time of exposure) distributions for 

responders and survivors were assumed 

to be the same as current members in 

the WTC Health Program. According to 

WTC Health Program data, males 

comprise 88 percent of the current 

responder members and 50 percent of 

survivor members. Because prostate 

cancer occurs only in males, all 

calculations only take into account male 

WTC Health Program members. The age 

distribution for current members by 

gender and responder/survivor status is 

presented in Table B. 

TABLE B—PERCENTILES OF CURRENT AGE (ON APRIL 11, 2012) FOR CURRENT MEMBERS IN THE WTC HEALTH

PROGRAM BY GENDER AND RESPONDER/SURVIVOR STATUS

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: 46 57 percent nonHispanic white, 15 percent nonVerDate Mar<15>2010 16:10 Jul 01, 2013 Jkt 229001 PO 00000 Frm 00046 Fmt 4702 Sfmt 4702 E:\FR\FM\02JYP1.SGM 02JYP1

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39678 Federal Register / Vol. 78, No. 127 / Tuesday, July 2, 2013 / Proposed Rules 

47Centers 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. 48Schubauer-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. 

49National Cancer Institute, Surveillance 

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

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

50National Cancer Institute, Surveillance 

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

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

51The 15-year survival limit is imposed based on 

the analytic time horizon. 

52National Cancer Institute, Surveillance 

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

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

Hispanic black, 21 percent Hispanic, 

and 8 percent other race/ethnicity for 

responders and 50 percent non-Hispanic 

white, 17 percent non-Hispanic black, 

15 percent Hispanic, and 18 percent 

other race/ethnicity for survivors. 

Follow-up for cancer morbidity for each 

person began on January 1, 2002 or age 

15 years, whichever was later. Age 15 

was considered because the cancer 

incidence rate file did not include rates 

for persons less than 15 years of age. 

Follow-up ended on December 31, 2016 

or the estimated last year of life, 

whichever was earlier. The estimated 

last year of life was used since not all 

persons would be expected to remain 

alive at the end of 2016. The estimated 

last year of life was based on U.S. 

gender, race, age, and year-specific 

death rates from CDC Wonder (since 

rates are currently available through 

2008, the rate from 2008 was applied to 

2009 and later).47 A life-table analysis 

program, LTAS.NET, was used to 

estimate the expected number of 

incident cancers for prostate cancer.48

The Administrator calculated cancer 

incidence rates using data through 2006 

from the Surveillance Epidemiology and 

End Results (SEER) Program and 

estimated rates for 2007–2016.49 The 

Program applied the resulting gender, 

race, age, and year-specific cancer 

incidence rates to the estimated personyears at risk to estimate the expected 

number of cancer cases for prostate 

cancer starting from year 2002, the first 

full year following the September 11, 

2001, terrorist attacks, to 2016, the last 

year for which this Program is currently 

funded. 

Prevalence of Cancer 

To determine the potential number of 

persons in the responder and survivor 

populations with cancer, the 

Administrator used the number of 

incident cases described above for each 

year starting with 2002 and estimated 

the prevalence of cancer using survival 

rate statistics for each incident cancer 

group through 2016.50 Using the 

incident cases and survival rate 

statistics, HHS has estimated the 

prevalence (number of persons living 

with cancer) of cases during the 15 year 

period (2002–2016) since September 11, 

2001. The resulting table provides for 

each year from 2002 through 2016, the 

number of new cases occurring in that 

year (incidence), the number of 

individuals who died from their cancer 

in that year, and the number of persons 

surviving up to 15 years beyond their 

first diagnosis (prevalence).51 For 

example, in 2002 there are 34.22 

projected new cases of prostate cancer, 

which would be listed as incident cases 

for that year. The survival rate for 

prostate cancer in the first year of 

diagnosis is 99.44 percent.52 Therefore 

the number of deceased persons in 2002 

would be 34.22 × (1 ¥ 0.9944) = 0.19. 

For the prostate cancer prevalence table, 

in year 2003, the number of incident 

cases would be 38.55 cases. In addition 

to 38.55 newly diagnosed cases in 2003, 

there would be the one-year survivors 

from 2002 which would be 34.22 ¥ 0.19 

= 34.03 cases. This computation process 

can be repeated for each year through 

year 2016. A portion of the prostate 

cancer prevalence tables are provided in 

Table C. Prevalence is summarized in 

Tables E and G. This analysis considers 

cancers diagnosed in 2002 through 

2016. 

TABLE C—PREVALENCE TABLE FOR PROSTATE CANCER

[Based on 80,000 responders] 

Year Years since 9/11 exposure Years covered by WTC Health 

Program 

New/Surv. 2002 2003 2013 2014 2015 

1 ............................................................... 34.22 38.55 112.54 123.98 134.46 146.33 

2 ............................................................... ........................ 34.03 100.76 111.92 123.29 133.72 

3 ............................................................... ........................ ........................ 88.67 99.55 110.57 121.81 

4 ............................................................... ........................ ........................ 79.02 87.58 98.33 109.22 

5 ............................................................... ........................ ........................ 71.15 78.61 87.13 97.82 

6 ............................................................... ........................ ........................ 63.27 70.41 77.80 86.23 

7 ............................................................... ........................ ........................ 55.71 62.74 69.83 77.15 

8 ............................................................... ........................ ........................ 48.22 55.06 62.01 69.01 

9 ............................................................... ........................ ........................ 42.10 47.91 54.71 61.61 

10 ............................................................. ........................ ........................ 39.77 41.51 47.24 53.95 

11 ............................................................. ........................ ........................ 35.02 39.38 41.11 46.77 

12 ............................................................. ........................ ........................ 30.91 34.83 39.17 40.88 

13 ............................................................. ........................ ........................ ........................ 30.43 34.29 38.56 

14 ............................................................. ........................ ........................ ........................ ........................ 30.26 34.10 

15 ............................................................. ........................ ........................ ........................ ........................ ........................ 30.06 

Live cases from previous years ............... 0.00 34.03 654.61 759.95 875.74 1000.89 

Prevalence ............................................... 34.22 72.58 767.15 883.93 1010.20 1147.22 

Last year of life ........................................ 0.19 0.62 7.20 8.19 9.31 10.65 

Cost Computation 

To compute the costs for prostate 

cancer, the Administrator assumes that 

all of the individuals who are diagnosed 

with prostate cancer will be certified by 

the WTC Health Program for treatment 

and monitoring services. The treatment 

costs for the first year of treatment 

(Table A, year adjusted) were applied to 


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53Zeig-Owens R, Webber MP, Hall CB, Schwartz 

T, Jaber N, Weakley J, Rohan TE, Cohen HW, 

Derman O, Aldrich TK, Kelly K, Prezant DJ [2011]. 

Early Assessment of Cancer Outcomes in New York 

City Firefighters After the 9/11 Attacks: An 

Observational Cohort Study. Lancet. 378(9794):898– 

905. Limitations of the Zeig-Owens study include: 

limited information on specific exposures 

experienced by firefighters; short time for follow-up 

of cancer outcomes; speculation about the 

biological plausibility of chronic inflammation as a 

possible mediator between WTC-exposure and 

cancer outcomes; and potential unmeasured 

confounders. 

the predicted newly incident (Year 1) 

cases for each year. Likewise, the costs 

of treatment for the last year of life were 

applied in each year to the number of 

people predicted to die from their 

cancer in that year. The costs of 

continuing treatment from Table A were 

applied to the number of prevalent cases 

who had survived their cancers beyond 

their year of diagnosis, for each year of 

survival (Year 2–15). 

Using this procedure, a cost table was 

constructed for each year covered by the 

WTC Health Program and the results are 

presented in Table D. The row for Year 

1 in each table is the cost of incident 

cases for that year. Rows for years 2–15 

show the cost from continuing care for 

persons surviving n-years beyond the 

year of diagnosis. Finally, the cost of 

last year of life treatment is computed 

by multiplying the cost for last year of 

life from Table A by the number of 

persons dying in that year from prostate 

cancer from Table C. 

TABLE D—COST PER 80,000 RESPONDERS FOR PROSTATE CANCER, 2011$ 

Year 

Years covered by the WTC Health Program 

2014 2015 2016 

1 ................................................................................................................................................... $1,688,586 $1,831,435 $1,993,026 

2 ................................................................................................................................................... 308,251 339,563 368,289 

3 ................................................................................................................................................... 274,159 304,530 335,464 

4 ................................................................................................................................................... 241,216 270,809 300,809 

5 ................................................................................................................................................... 216,509 239,972 269,413 

6 ................................................................................................................................................... 193,930 214,266 237,486 

7 ................................................................................................................................................... 172,786 192,305 212,470 

8 ................................................................................................................................................... 151,653 170,779 190,071 

9 ................................................................................................................................................... 131,942 150,680 169,685 

10 ................................................................................................................................................. 114,331 130,098 148,574 

11 ................................................................................................................................................. 108,466 113,209 128,822 

12 ................................................................................................................................................. 95,925 107,868 112,586 

13 ................................................................................................................................................. 83,816 94,438 106,196 

14 ................................................................................................................................................. ........................ 83,345 93,906 

15 ................................................................................................................................................. ........................ ........................ 82,779 

Prevalent care .............................................................................................................................. 3,781,570 4,243,298 4,666,796 

Last year of life care .................................................................................................................... 356,227 404,804 463,183 

Total ...................................................................................................................................... 4,137,798 4,648,102 5,129,979 

The sum of the annual costs in the 

table for the years 2014 through 2016 

represents the estimated treatment costs 

to the WTC Health Program for coverage 

of prostate cancer for 80,000 responders. 

The same process described above was 

applied to the survivor cohort. Based on 

the incidence rate expected from the 

survivor cohort, prevalence tables were 

constructed. The estimated treatment 

costs for responders and survivors were 

re-computed under the following two 

assumptions: (1) The rate of cancer in 

the WTC Health Program is equal to the 

rate of cancer observed in the general 

population; and (2) the rate of cancer 

exceeds the general population rate by 

21 percent due to their WTC 

exposures.53

A summary of the estimated 

prevalence at the U.S. population 

average for the assumed population of 

58,500 responders and 6,500 survivors 

is provided in Table E. A summary of 

the estimated treatment costs to the 

WTC Health Program is provided in 

Table F. A summary of the estimated 

prevalence using cancer rates 21 percent 

over the U.S. population average for the 

increased rate of 80,000 responders and 

30,000 survivors is given in Table G. A 

summary of the estimated treatment 

costs to the WTC Health Program is 

provided in Table H. 

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

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

Population 

Prevalence (incident + live cases) 

2014 2015 2016 

Based on 58,500 responders ...................................................................................................... 646.37 738.71 838.90 

Based on 6,500 survivors ............................................................................................................ 65.95 73.93 82.41 


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

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

Population 2014 2015 2016 2014–2016 

Based on 58,500 responders .......................................................................... 3,025,765 3,398,924 3,751,298 10,175,987 

Based on 6,500 survivors ................................................................................ 296,297 326,642 352,170 975,109 

TABLE G—ESTIMATED PREVALENCE OF PROSTATE CANCER BY YEAR BASED ON 80,000 AND 30,000 RESPONDER AND

SURVIVOR POPULATION, RESPECTIVELY AND ASSUMING INCIDENCE OF CANCER IS 21% HIGHER THAN THE U.S. POPULATION DUE TO 9/11 EXPOSURE

Population 

Prevalence (incident + live cases) 

2014 2015 2016 

Based on 80,000 responders ...................................................................................................... 1069.55 1222.34 1388.13 

Based on 30,000 survivors .......................................................................................................... 368.31 412.86 460.19 

TABLE H—ESTIMATED TREATMENT COSTS OF PROSTATE CANCER BY YEAR BASED ON 80,000 AND 30,000 RESPONDER

AND SURVIVOR POPULATION, RESPECTIVELY AND ASSUMING INCIDENCE OF CANCER IS 21% HIGHER THAN THE U.S. 

POPULATION DUE TO 9/11 EXPOSURE (2011 $) 

Population 2014 2015 2016 2014–2016 

Based on 80,000 responders .......................................................................... $5,089,491 $5,717,165 $6,309,875 $17,116,531 

Based on 30,000 survivors .............................................................................. 1,378,925 1,520,138 1,638,947 4,538,010 

Summary of Costs 

Because HHS lacks data to account for 

recoupment by workers’ compensation 

insurance or reduction by either health 

insurance or Medicare/Medicaid 

payments, the estimates offered here are 

reflective of estimated WTC Health 

Program costs only. This analysis offers 

an assumption about the number of 

individuals who might enroll in the 

WTC Health Program and estimates the 

impact of both a low rate of cancer (U.S. 

population average rate) and an 

increased rate (21 percent greater than 

the U.S. population average) on the 

number of cases and the resulting 

estimated treatment costs to the WTC 

Health Program. This analysis does not 

include administrative costs associated 

with certifying additional diagnoses of 

cancers that are WTC-related health 

conditions that might result from this 

action. Those costs were addressed in 

the interim final rule that established 

regulations for the WTC Health Program 

(76 FR 38914, July 1, 2011). 

After the implementation of 

provisions of the Affordable Care Act on 

January 1, 2014, all of the members and 

future members can be assumed to have 

or have access to medical insurance 

coverage other than through the WTC 

Health Program. Therefore, all treatment 

and screening costs to be paid by the 

WTC Health Program from 2014 through 

2016 are considered transfers. Table I 

describes the allocation of WTC Health 

Program transfer payments based on 

58,500 responders and 6,500 survivors 

and, alternatively, 80,000 responders 

and 30,000 survivors. 

TABLE I—BREAKDOWN OF ESTIMATED ANNUAL WTC HEALTH PROGRAM TRANSFERS FOR PROSTATE CANCER BASED ON

80,000 AND 58,500 RESPONDERS AND 30,000 AND 6,500 SURVIVORS, 2014–2016, 2011$ 

Annualized transfers for 2014– 

2016, 2011 $ 

Discounted at 7 

percent 

Discounted at 3 

percent 

Cancer Rate 

U.S. average U.S. average + 

21% 

58,500 Responders ......................................................................................................................................... $3,159,619 ............................

6,500 Survivors ................................................................................................................................................ 303,056 ............................

65,000 Total .............................................................................................................................................. $3,462,675 ............................

80,000 Responders ......................................................................................................................................... ............................ $5,529,266 

30,000 Survivors .............................................................................................................................................. ............................ 1,466,551 

110,000 Total ............................................................................................................................................ ............................ 6,995,817 

Examination of Benefits (Health Impact) 

This section describes qualitatively 

the potential benefits of the proposed 

rule in terms of the expected 

improvements in the health and healthrelated quality of life of potential 

prostate cancer patients treated through 

the WTC Health Program, compared to 

no Program. The assessment of the 


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54Ward 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. 55Wharam JF, Galbraith AA, Kleinman KP, 

Soumerai SB, Ross-Degnan D, Landon BE. Cancer 

Screening before and after Switching to a HighDeductible Health Plan. Annals of Internal 

Medicine. 2008 May;148(9):647–655. 

health benefits for prostate cancer 

patients uses the number of expected 

cancer cases that was estimated in the 

cost analysis section. 

The Administrator does not have 

information on the health of the 

population that may have experienced 

9/11 exposures and is not currently 

enrolled in the WTC Health Program. In 

addition, the Administrator has only 

limited information about health 

insurance and health care services for 

prostate cancers potentially caused by 

9/11 exposures and suffered by any 

population of responders and survivors, 

including responders and survivors 

currently enrolled in the WTC Health 

Program and responders and survivors 

not enrolled in the Program. For the 

purposes of this analysis, the 

Administrator assumes that broad 

trends on demographics and access to 

health insurance reported by the U.S. 

Census Bureau and health care services 

for cancer similar to those reported by 

Ward et al. 54 would apply to the 

population of general responders (those 

individuals who are not members of the 

FDNY and who meet the eligibility 

criteria in 42 CFR Part 88 for WTC 

responders) and survivors both within 

and outside the Program. For the 

purposes of this analysis, the 

Administrator assumes that access to 

health insurance and health care 

services for FDNY responders within 

and outside the Program would be 

equivalent because this population is 

overwhelmingly covered by employerbased health insurance. 

Although the Administrator cannot 

quantify the benefits associated with the 

WTC Health Program, members with 

prostate cancer would have improved 

access to care and thereby the Program 

should produce better treatment 

outcomes than in its absence. Under 

other insurance plans, patients would 

have deductibles and copays, which 

impact access to care and particularly 

its timeliness.55 WTC Health Program 

members would have first-dollar 

coverage and hence are likely to seek 

care sooner when indicated, resulting in 

improved treatment outcomes. 

Limitations 

The analysis presented here was 

limited by the dearth of verifiable data 

on the prostate cancer status of 

responders and survivors who have yet 

to apply for enrollment in the WTC 

Health Program. Because of the limited 

data, the Administrator was not able to 

estimate benefits in terms of averted 

healthcare costs. Nor was the 

Administrator able to estimate 

administrative costs, or indirect costs, 

such as averted absenteeism, short and 

long-term disability, and productivity 

losses averted due to premature 

mortality. 

B. Regulatory Flexibility Act 

The Regulatory Flexibility Act (RFA), 

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

agency to consider the potential impact 

of its regulations on small entities 

including small businesses, small 

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

believes that this rule has ‘‘no 

significant economic impact upon a 

substantial number of small entities’’ 

within the meaning of the Regulatory 

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

C. Paperwork Reduction Act 

The Paperwork Reduction Act (PRA), 

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

agency to invite public comment on, 

and to obtain OMB approval of, any 

regulation that requires 10 or more 

people to report information to the 

agency or to keep certain records. Data 

collection and recordkeeping 

requirements for the WTC Health 

Program are approved by OMB under 

‘‘World Trade Center Health Program 

Enrollment, Appeals & Reimbursement’’ 

(OMB Control No. 0920–0891, exp. 

December 31, 2014). The Administrator 

has determined that no changes are 

needed to the information collection 

request already approved by OMB. 

D. Small Business Regulatory 

Enforcement Fairness Act 

As required by Congress under the 

Small Business Regulatory Enforcement 

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

seq.), HHS will report the promulgation 

of this rule to Congress prior to its 

effective date. 

E. Unfunded Mandates Reform Act of 

1995 

Title II of the Unfunded Mandates 

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

seq.) directs agencies to assess the 

effects of Federal regulatory actions on 

State, local, and Tribal governments, 

and the private sector ‘‘other than to the 

extent that such regulations incorporate 

requirements specifically set forth in 

law.’’ For purposes of the Unfunded 

Mandates Reform Act, this proposed 

rule does not include any Federal 

mandate that may result in increased 

annual expenditures in excess of $100 

million in 1995 dollars by State, local or 

Tribal governments in the aggregate, or 

by the private sector. However, the rule 

may result in an increase in the 

contribution made by New York City for 

treatment and monitoring, as required 

by Title XXXIII, § 3331(d)(2). For 2013, 

the inflation adjusted threshold is $150 

million. 

F. Executive Order 12988 (Civil Justice) 

This proposed rule has been drafted 

and reviewed in accordance with 

Executive Order 12988, ‘‘Civil Justice 

Reform,’’ and will not unduly burden 

the Federal court system. This rule has 

been reviewed carefully to eliminate 

drafting errors and ambiguities. 

G. Executive Order 13132 (Federalism) 

The Administrator has reviewed this 

proposed rule in accordance with 

Executive Order 13132 regarding 

federalism, and has determined that it 

does not have ‘‘federalism 

implications.’’ The rule does not ‘‘have 

substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government.’’ 

H. Executive Order 13045 (Protection of 

Children From Environmental Health 

Risks and Safety Risks) 

In accordance with Executive Order 

13045, the Administrator has evaluated 

the environmental health and safety 

effects of this proposed rule on children. 

The Administrator has determined that 

the rule would have no environmental 

health and safety effect on children. 

I. Executive Order 13211 (Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use) 

In accordance with Executive Order 

13211, the Administrator has evaluated 

the effects of this proposed rule on 

energy supply, distribution or use, and 

has determined that the rule will not 

have a significant adverse effect. 

J. Plain Writing Act of 2010 

Under Public Law 111–274 (October 

13, 2010), executive Departments and 

Agencies are required to use plain 

language in documents that explain to 

the public how to comply with a 

requirement the Federal Government 

administers or enforces. The 

Administrator has attempted to use 

plain language in promulgating the 

proposed rule consistent with the 

Federal Plain Writing Act guidelines. 


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Proposed Rule 

List of Subjects in 42 CFR Part 88: 

Aerodigestive disorders, Appeal 

procedures, Cancer, Health care, Mental 

health conditions, Musculoskeletal 

disorders, Respiratory and pulmonary 

diseases. 

For the reasons discussed in the 

preamble, the Department of Health and 

Human Services proposes to amend 42 

CFR Part 88 as follows: 

PART 88—WORLD TRADE CENTER 

HEALTH PROGRAM 

■ 1. The authority citation for Part 88 

continues to read as follows: 

Authority: 42 U.S.C. 300mm–300mm–61, 

Pub. L. 111–347, 124 Stat. 3623. 

■ 2. In § 88.1, the under the definition 

‘‘List of WTC-related health 

conditions’’, following paragraph (4), 

revise Table 1 to read as follows: 

§ 88.1 Definitions. 

* * * * * 

List of WTC-related health conditions 

* * * 

(4) * * * 

BILLING CODE 4150–28–P 


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Federal Register / Vol. 78, No. 127 / Tuesday, July 2, 2013 / Proposed Rules 39691 

Dated: June 26, 2013. 

John Howard, 

Administrator, World Trade Center, Health 

Program and Director, National Institute for 

Occupational Safety and Health, Centers for 

Disease Control and Prevention, Department 

of Health and Human Services. 

[FR Doc. 2013–15816 Filed 7–1–13; 8:45 am] 

BILLING CODE 4150–28–C 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 79 

[MB Docket No. 11–154; FCC 13–84] 

Closed Captioning of Internet ProtocolDelivered Video Programming: 

Implementation of the Twenty-First 

Century Communications and Video 

Accessibility Act of 2010 

AGENCY: Federal Communications 

Commission. 

ACTION: Proposed rule. 

SUMMARY: In this document, the 

Commission seeks comment on the 

potential imposition of closed 

captioning synchronization 

requirements for covered apparatus, and 

on how DVD and Blu-ray players can 

fulfill the closed captioning 

requirements of the statute. These issues 

were raised by petitions for 

reconsideration of the Report and Order, 

which adopted rules governing the 

closed captioning requirements for the 

owners, providers, and distributors of 

IP-delivered video programming and 

rules governing the closed captioning 

capabilities of certain apparatus on 

which consumers view video 

programming. 

DATES: Comments are due on or before 

September 3, 2013; reply comments are 

due on or before September 30, 2013. 

ADDRESSES: You may submit comments, 

identified by MB Docket No. 11–154, by 

any of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Federal Communications 

Commission’s Web site: http:// 

fjallfoss.fcc.gov/ecfs2/. Follow the 

instructions for submitting comments. 

• Mail: Filings can be sent by hand or 

messenger delivery, by commercial 

overnight courier, or by first-class or 

overnight U.S. Postal Service mail. All 

filings must be addressed to the 

Commission’s Secretary, Office of the 

Secretary, Federal Communications 

Commission. 

• People with Disabilities: Contact the 

FCC to request reasonable 

accommodations (accessible format 

documents, sign language interpreters, 

CART, etc.) by email: FCC504@fcc.gov 

or phone: (202) 418–0530 or TTY: (202) 

418–0432. 

FOR FURTHER INFORMATION CONTACT: 

Diana Sokolow, Diana.Sokolow@fcc.gov, 

or Maria Mullarkey, 

Maria.Mullarkey@fcc.gov, of the Policy 

Division, Media Bureau, (202) 418– 

2120. 

SUPPLEMENTARY INFORMATION: This is a 

summary of the Commission’s Further 

Notice of Proposed Rulemaking, FCC 

13–84, adopted on June 13, 2013 and 

released on June 14, 2013. The full text 

of this document is available for public 

inspection and copying during regular 

business hours in the FCC Reference 

Center, Federal Communications 

Commission, 445 12th Street SW., Room 

CY–A257, Washington, DC 20554. This 

document will also be available via 

ECFS at http://fjallfoss.fcc.gov/ecfs/. 

Documents will be available 

electronically in ASCII, Microsoft Word, 

and/or Adobe Acrobat. The complete 

text may be purchased from the 

Commission’s copy contractor, 445 12th 

Street SW., Room CY–B402, 

Washington, DC 20554. Alternative 

formats are available for people with 

disabilities (Braille, large print, 

electronic files, audio format), by 

sending an email to fcc504@fcc.gov or 

calling the Commission’s Consumer and 

Governmental Affairs Bureau at (202) 

418–0530 (voice), (202) 418–0432 

(TTY). 

Paperwork Reduction Act of 1995 

Analysis 

This document does not contain 

proposed information collection(s) 

subject to the Paperwork Reduction Act 

of 1995 (PRA), Public Law 104–13. In 

addition, therefore, it does not contain 

any new or modified ‘‘information 

collection burden for small business 

concerns with fewer than 25 

employees,’’ pursuant to the Small 

Business Paperwork Relief Act of 2002, 

Public Law 107–198, see 44 U.S.C. 

3506(c)(4). 

Summary of the Further Notice of 

Proposed Rulemaking 

I. Introduction 

1. In the FNPRM, we seek further 

comment on the potential imposition of 

closed captioning synchronization 

requirements for covered apparatus, and 

on how DVD and Blu-ray players can 

fulfill the closed captioning 

requirements of the statute. These issues 

were raised by petitions for 

reconsideration of the Report and Order, 

which implemented portions of sections 

202 and 203 of the Twenty-First Century 

Communications and Video 

Accessibility Act of 2010 (‘‘CVAA’’) by 

adopting rules governing the closed 

captioning requirements for the owners, 

providers, and distributors of video 

programming delivered via Internet 

protocol (‘‘IP’’) and rules governing the 

closed captioning capabilities of certain 

apparatus on which consumers view 

video programming. Specifically, in 

response to the Petition for 

Reconsideration of Consumer Groups, 

we issue an FNPRM to obtain further 

information necessary to determine 

whether the Commission should impose 

synchronization requirements on device 

manufacturers. Such synchronization 

requirements could provide that all 

apparatus that render closed captions 

must do so consistent with the timing 

data included with the video 

programming the apparatus receives. 

Separately, in response to issues raised 

by the Petition for Reconsideration of 

the Consumer Electronics Association, 

the FNPRM seeks comment on how 

DVD and Blu-ray players can fulfill the 

closed captioning requirements of the 

statute. 

2. Our goal in this proceeding remains 

to implement Congress’s intent to better 

enable individuals who are deaf or hard 

of hearing to view video programming. 

In considering the requests made in the 

three petitions for reconsideration 

received, we have evaluated the effect 

on consumers who are deaf or hard of 

hearing as well as the cost of 

compliance to affected entities. 

II. Further Notice of Proposed 

Rulemaking 

3. Apparatus synchronization 

requirements. We invite comment on 

whether the Commission should require 

apparatus manufacturers to ensure that 

their apparatus synchronize the 

appearance of closed captions with the 

display of the corresponding video. In 

the Report and Order, the Commission 

concluded that it would be 

inappropriate to impose 

synchronization requirements on 

apparatus. Rather, the Commission 

stated ‘‘that ensuring that timing data is 

properly encoded and maintained 

through the captioning interchange and 

delivery system is an obligation of 

[s]ection 202 [video programming 

distributors and providers], and not of 

device manufacturers.’’ Consumer 

Groups argue that the Commission 

should impose timing obligations on 

device manufacturers pursuant to 

section 203 of the CVAA because 

apparatus may cause captions to become 

out of synch with the corresponding 

video. We need more information in the 


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