75528 Federal Register / Vol. 79, No. 243 / Thursday, December 18, 2014 / Proposed Rules 

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. 

submitted regulations revise Indiana’s 

ambient air quality standards for ozone 

and particulate matter to be consistent 

with EPA’s 2008 ozone and 2012 fine 

particulate matter National Ambient Air 

Quality Standards. EPA is therefore 

approving these SIP revisions in 

accordance with the requirements of the 

Clean Air Act. In the Final Rules section 

of this Federal Register, EPA is 

approving the State’s SIP submittal as a 

direct final rule without prior proposal 

because the Agency views this as a 

noncontroversial submittal and 

anticipates no adverse comments. A 

detailed rationale for the approval is set 

forth in the direct final rule. If no 

adverse comments are received in 

response to this action, no further 

activity is contemplated. If EPA receives 

adverse comments, the direct final rule 

will be withdrawn and all public 

comments received will be addressed in 

a subsequent final rule based on this 

proposed rule. EPA will not institute a 

second comment period. Any parties 

interested in commenting on this action 

should do so at this time. 

DATES: Comments must be received on 

or before January 20, 2015. 

ADDRESSES: Submit your comments, 

identified by Docket ID No. EPA–R05– 

OAR–2014–0661, by one of the 

following methods: 

1. www.regulations.gov: Follow the 

on-line instructions for submitting 

comments. 

2. Email: aburano.douglas@epa.gov. 

3. Fax: (312) 408–2279. 

4. Mail: Douglas Aburano, Chief, 

Attainment Planning and Maintenance 

Section, Air Programs Branch (AR–18J), 

U.S. Environmental Protection Agency, 

77 West Jackson Boulevard, Chicago, 

Illinois 60604. 

5. Hand Delivery: Douglas Aburano, 

Chief, Attainment Planning and 

Maintenance Section, Air Programs 

Branch (AR–18J), U.S. Environmental 

Protection Agency, 77 West Jackson 

Boulevard, Chicago, Illinois 60604. 

Such deliveries are only accepted 

during the Regional Office normal hours 

of operation, and special arrangements 

should be made for deliveries of boxed 

information. The Regional Office official 

hours of business are Monday through 

Friday, 8:30 a.m. to 4:30 p.m., excluding 

Federal holidays. 

Please see the direct final rule which 

is located in the Rules section of this 

Federal Register for detailed 

instructions on how to submit 

comments. 

FOR FURTHER INFORMATION CONTACT: Eric 

Svingen, Environmental Engineer, 

Attainment Planning and Maintenance 

Section, Air Programs Branch (AR–18J), 

Environmental Protection Agency, 

Region 5, 77 West Jackson Boulevard, 

Chicago, Illinois 60604, (312) 353–4489, 

svingen.eric@epa.gov. 

SUPPLEMENTARY INFORMATION: In the 

Final Rules section of this Federal 

Register, EPA is approving the State’s 

SIP submittal as a direct final rule 

without prior proposal because the 

Agency views this as a noncontroversial 

submittal and anticipates no adverse 

comments. A detailed rationale for the 

approval is set forth in the direct final 

rule. If no adverse comments are 

received in response to this rule, no 

further activity is contemplated. If EPA 

receives adverse comments, the direct 

final rule will be withdrawn and all 

public comments received will be 

addressed in a subsequent final rule 

based on this proposed rule. EPA will 

not institute a second comment period. 

Any parties interested in commenting 

on this action should do so at this time. 

Please note that if EPA receives adverse 

comment on an amendment, paragraph, 

or section of this rule and if that 

provision may be severed from the 

remainder of the rule, EPA may adopt 

as final those provisions of the rule that 

are not the subject of an adverse 

comment. For additional information, 

see the direct final rule which is located 

in the Rules section of this Federal 

Register. 

Dated: December 5, 2014. 

Susan Hedman, 

Regional Administrator, Region 5. 

[FR Doc. 2014–29587 Filed 12–17–14; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

42 CFR Part 88 

World Trade Center Health Program; 

Petition 006—Primary Biliary Cirrhosis; 

Finding of Insufficient Evidence 

AGENCY: Centers for Disease Control and 

Prevention, HHS. 

ACTION: Denial of petition for addition of 

a health condition. 

SUMMARY: On October 20, 2014, the 

Administrator of the World Trade 

Center (WTC) Health Program received 

a petition to add primary biliary 

cirrhosis (Petition 006) to the List of 

WTC-Related Health Conditions (List). 

The Administrator has not found 

sufficient scientific evidence to conduct 

an analysis of whether to add primary 

biliary cirrhosis to the List. Accordingly, 

the Administrator finds that insufficient 

evidence exists to request a 

recommendation of the WTC Health 

Program Scientific/Technical Advisory 

Committee (STAC), to publish a 

proposed rule, or to publish a 

determination not to publish a proposed 

rule. 

DATES: The Administrator of the WTC 

Health Program is denying this petition 

for the addition of a health condition as 

of December 18, 2014. 

FOR FURTHER INFORMATION CONTACT: 

Rachel Weiss, Program Analyst, 1090 

Tusculum Ave., MS: C–46, Cincinnati, 

OH 45226; telephone (855)818–1629 

(this is a toll-free number); email 

NIOSHregs@cdc.gov. 

SUPPLEMENTARY INFORMATION: 

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 who responded to the 

September 11, 2001, terrorist attacks in 

New York City, at the Pentagon, and in 

Shanksville, Pennsylvania (responders), 

and to eligible persons who were 

present in the dust or dust cloud on 

September 11, 2001 or who worked, 

resided, or attended school, childcare, 

or adult daycare in the New York City 

disaster area (survivors). 

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. 

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

the PHS Act, interested parties may 

petition the Administrator to add a 

health condition to the List in 42 CFR 

88.1. 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 section 3312(a)(6)(B) and 

42 CFR 88.17: (i) Request a 

recommendation of the 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 

mstockstill on DSK4VPTVN1PROD with PROPOSALS

Federal Register / Vol. 79, No. 243 / Thursday, December 18, 2014 / Proposed Rules 75529 

2See Petition 006. WTC Health Program: Petitions 

Received. http://www.cdc.gov/wtc/received.html. 

3Smyk D, Mytilinaiou MG, Rigopoulou EI, 

Bogdanos DP [2010]. PBC triggers in water 

reservoirs, coal mining areas and waste disposal 

sites: from Newcastle to New York. Disease Markers 

29:337–344; Pleil JD, Vette AF, Johnson BA, 

Rappaport SM [2004]. Air levels of carcinogenic 

polycyclic aromatic hydrocarbons after the World 

Trade Center disaster. PNAS 101(32):11685–11688; 

Dronamraju D, Odin J, Bach N [2010]. Primary 

biliary cirrhosis: environmental risk factors. Disease 

Markers 29:323–328; Selmi C, De Santis M, 

Cavaciocchi F, Gershwin ME [2010]. Infectious 

agents and xenobiotics in the etiology of primary 

biliary cirrhosis. Disease Markers 29:287–299; 

September 11th Worker Protection Task Force. 

Interim Report. March 4, 2008; Walsh N [2014]. 

Asbestos revisited: a new autoimmune disease? 

MedPage Today at http://www.medpagetoday.com/ 

Rheumatology/GeneralRheumatology/46972; 

Speck-Hernandez CA and Montoya-Ortiz G [2012]. 

Silicon, a possible link between environmental 

exposure and autoimmune diseases: the case of 

rheumatoid arthritis. Arthritis at http://dx.doi.org/

10.1155/2012/604187. 

4This methodology, ‘‘Policy and Procedures for 

Adding Non-Cancer Conditions to the List of WTCRelated Health Conditions,’’ revised October 21, 

2014, is available on the WTC Health Program Web 

site, at http://www.cdc.gov/wtc/policies.html. 

5The substantial evidence standard is met when 

the Program assesses all of the available, relevant 

information and determines with high confidence 

that the evidence supports its findings regarding a 

causal association between the 9/11 exposure(s) and 

the health condition. 

6The modest evidence standard is met when the 

Program assesses all of the available, relevant 

information and determines with moderate 

confidence that the evidence supports its findings 

regarding a causal association between the 9/11 

exposure(s) and the health condition. 

7 9/11 agents are chemical, physical, biological, or 

other agents or hazards reported in a published, 

peer-reviewed exposure assessment study of 

responders or survivors who were present in either 

the New York City disaster area, the Pentagon site, 

or in Shanksville, Pennsylvania site as defined in 

42 CFR part 88. 

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. 

B. Petition 006 

On October 20, 2014, the 

Administrator received a petition to add 

primary biliary cirrhosis to the List 

(Petition 006).2 The petition was 

submitted by a Salvation Army 

responder who worked at Ground Zero 

in the aftermath of the September 11, 

2001, terrorist attacks. The petitioner 

stated that she had been diagnosed with 

primary biliary cirrhosis and shared 

letters from her personal physicians 

confirming the diagnosis. The petition 

offered as evidence a number of articles 

identifying potential associations 

between primary biliary cirrhosis and 

other autoimmune diseases to various 

environmental exposures, including 

polycyclic aromatic hydrocarbons, 

xenobiotics, asbestos, and silicon.3

C. Administrator’s Determination on 

Petition 006 

The Administrator has established a 

methodology for evaluating whether to 

add non-cancer health conditions to the 

List of WTC-Related Health Conditions.4

First, the Administrator determines 

whether published, peer-reviewed 

studies about the health condition 

among 9/11-exposed populations are 

available to assess evidence for a causal 

relationship and provide a basis for a 

decision on whether to add the 

condition to the List. If the studies 

provide sufficient evidence for analysis, 

the Administrator proceeds with an 

assessment of the information. A health 

condition may be added to the List if 

published, peer-reviewed direct 

observational or epidemiologic studies 

provide substantial support 5 for a 

causal relationship between 9/11 

exposures and the health condition in 

9/11-exposed populations. If only 

epidemiologic studies are available and 

they provide only modest support 6 for 

a causal relationship between 9/11 

exposures and the health condition, the 

Administrator may then evaluate 

studies of associations between the 

health condition and 9/11 agents.7 If 

that additional assessment establishes 

substantial support for a causal 

relationship between a 9/11 agent or 

agents and the health condition, the 

health condition may be added to the 

List. 

In accordance with section 

3312(a)(6)(B) of the PHS Act and 42 CFR 

88.17, described above, the 

Administrator has reviewed the 

evidence presented in Petition 006. 

None of the articles presented with the 

petition provide sufficient evidence of a 

causal relationship between primary 

biliary cirrhosis and 9/11 exposures to 

establish a basis for a decision on 

whether to add primary biliary cirrhosis 

to the List. Although some of the articles 

identify potential associations between 

specific 9/11 agents and primary biliary 

cirrhosis or autoimmune disease in 

general, none of the articles are peerreviewed direct observational or 

epidemiologic studies of 9/11 

populations, as required by the 

methodology described above. 

In addition to reviewing the evidence 

provided in Petition 006, the 

Administrator also conducted a search 

of the existing scientific/medical 

literature for evidence that could 

establish a causal relationship between 

9/11 exposures and primary biliary 

cirrhosis. He did not find any peerreviewed, published direct 

observational or epidemiologic studies 

of 9/11-exposed populations which 

would support such a relationship. 

Because neither the evidence 

submitted by the Petitioner nor a search 

of published scientific/medical 

literature provided information 

regarding the occurrence of primary 

biliary cirrhosis among 9/11-exposed 

populations, the Administrator has 

determined that requesting a 

recommendation from the STAC 

(pursuant to PHS Act, section 

3312(a)(6)(B)(i) and 42 CFR 

88.17(a)(2)(i)) is unwarranted. In prior 

actions, the Administrator requested a 

recommendation from the STAC when 

he determined that it would assist his 

evaluation; such as when, for example, 

the Administrator is in need of an 

interpretation of conflicting or 

inconclusive published scientific 

evidence. 

Similarly, the Administrator has 

determined that insufficient evidence 

exists to take further action, including 

either proposing the addition of primary 

biliary cirrhosis to the List (pursuant to 

PHS Act, section 3312(a)(6)(B)(ii) and 42 

CFR 88.17(a)(2)(ii)) or publishing a 

determination not to publish a proposed 

rule in the Federal Register (pursuant to 

PHS Act, section 3312(a)(6)(B)(iii) and 

42 CFR 88.17(a)(2)(iii)). In order to 

publish such a proposed addition or a 

determination not to propose a rule, the 

Administrator would first need to find 

that enough scientific evidence is 

available to analyze whether 9/11 

exposures are associated with the health 

condition. Since the Administrator is 

unable to identify sufficient evidence to 

conduct an analysis of whether to add 

the health condition, the Administrator 

(pursuant to PHS Act, section 

3312(a)(6)(B)(iv) and 42 CFR 

88.17(a)(2)(iv)) is publishing a 

determination that he cannot take any of 

the other statutory and regulatory 

actions. 

For the reasons discussed above, the 

request made in Petition 006 to add 

primary biliary cirrhosis to the List of 

WTC-Related Health Conditions is 

denied. 

Dated: December 10, 2014. 

John Howard, 

Administrator, World Trade Center Health 

Program and Director, National Institute for 

Occupational Safety and Health, Centers for 

Disease Control and Prevention, Department 

of Health and Human Services. 

[FR Doc. 2014–29647 Filed 12–17–14; 8:45 am] 

BILLING CODE 4163–18–P 

mstockstill on DSK4VPTVN1PROD with PROPOSALS