[Federal Register Volume 78, Number 74 (Wednesday, April 17, 2013)]
[Rules and Regulations]
[Pages 22794-22795]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-09003]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 88


World Trade Center Health Program; Certification of Breast Cancer 
in WTC Responders and Survivors Exposed to PCBs

AGENCY: Centers for Disease Control and Prevention, HHS.

ACTION: Change in certification requirements.

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SUMMARY: On September 12, 2012, HHS published a final rule in the 
Federal Register adding certain types of cancer to the List of World 
Trade Center (WTC)-Related Health Conditions (List) established in the 
WTC Health Program regulation. Breast cancer was included on the List, 
although only individuals experiencing nighttime sleep disruption as a 
result of response and cleanup activities involving shiftwork are 
currently considered to have experienced exposure relevant for 
certification. A recent publication in The Lancet Oncology by the 
International Agency for Research on Cancer (IARC) concludes that there 
is limited evidence that polychlorinated biphenyls (PCBs) cause breast 
cancer in humans. As described below, the WTC Program Administrator 
(Administrator) has found that PCBs were present in WTC dust in the New 
York City disaster area and, accordingly, the Program will now certify 
breast cancer in eligible WTC responders and survivors who were exposed 
to either shiftwork/nighttime sleep disruption or PCBs as a result of 
the 9/11 attacks.

DATES: This change in certification requirements is effective April 17, 
2013.

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 
[email protected].

SUPPLEMENTARY INFORMATION:

A. Background

    On September 7, 2011, the Administrator received a written petition 
to add cancers to the List of WTC-Related Health Conditions in 42 CFR 
88.1 (Petition 001). On October 5, 2011, the Administrator formally 
exercised his option to request a recommendation from the WTC Health 
Program Scientific/Technical Advisory Committee (STAC) regarding the 
petition.\1\ The Administrator requested that the STAC ``review the 
available information on cancer outcomes associated with the exposures 
resulting from the September 11, 2001, terrorist attacks, and provide 
advice on whether to add cancer, or a certain type of cancer, to the 
List specified in the Zadroga Act.'' Following three public meetings 
where the Committee deliberated on the issues, the STAC submitted its 
recommendation on Petition 001 to the Administrator 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, HHS published a final rule in the Federal Register 
adding certain types of cancer to the List of WTC-Related Health 
Conditions in 42 CFR 88.1 [77 FR 56138]. On October 12, 2012, HHS 
published a Federal Register notice to correct errors in Table 1 of the 
final rule (the list of cancers covered by the Program) [77 FR 62167].
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    \1\ See 42 CFR 88.17(a)(2)(i).
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B. Administrator's Determination on the Inclusion of Female Breast 
Cancer

    In the final rule, the Administrator established a four-pronged 
Methodology for evaluating whether to add certain types of cancer to 
the List: Epidemiologic Studies of September 11, 2001 Exposed 
Populations (Method 1); Established Causal Associations (Method 2); 
Review of Evaluations of Carcinogenicity in Humans, requiring both 
Published Exposure Assessment Information, and Evaluation of 
Carcinogenicity in Humans from Scientific Studies (Method 3, including 
criteria 3A and 3B); and Review of Information Provided by the WTC 
Health Program Scientific/Technical Advisory Committee (Method 4). A 
full narrative description and graphic of the Methodology were 
published in the final rule [77 FR 56138, 56142-56143 (September 12, 
2012)].
    At the time of the Administrator's deliberation, breast cancer was 
determined to meet Method 4 (the STAC had provided a reasonable basis 
for its inclusion on the List). In its April 2, 2012 recommendation, 
the STAC had reported that:

    There is evidence of PCB [polychlorinated biphenyl] exposures to 
WTC responders and survivors based on air samples, window film 
samples and one biomonitoring study. Studies have linked total and 
congener-specific PCB levels in serum and adipose tissue with breast 
cancer, although evidence has been conflicting. PCBs and some other 
substances at the WTC site are endocrine disruptors. Breast cancer 
risks are highly related to hormonal factors, including endogenous 
and exogenous estrogens, and could plausibly be affected by 
endocrine disruptors. A recent study found that PCBs enhanced the 
metastatic properties of breast cancer cells by activating rho-
associated kinase. Shiftwork involving circadian rhythm disruption 
has been classified by IARC as probably carcinogenic to humans, 
based in part on epidemiologic studies associating shiftwork with 
increased risks of breast cancer. Both shiftwork and long shifts 
were common for workers involved in rescue, recovery, clean up, 
restoration and other activities at the WTC site.\2\ [references 
omitted]
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    \2\ STAC [World Trade Center Health Program Scientific/Technical 
Advisory Committee) [2012]. Letter from Elizabeth Ward, Chair to 
John Howard, MD, Administrator. This letter is included in NIOSH 
Docket 257, http://www.cdc.gov/niosh/docket/archive/docket257.html.

    Although the STAC specified that PCBs might be causally associated 
with breast cancer, the Committee provided stronger evidence (IARC 
classification as a carcinogen) that shiftwork

[[Page 22795]]

involving circadian rhythm disruption, as a 9/11 exposure, could be 
associated with breast cancer.\3\ For that reason, the Administrator 
determined that breast cancer would be included on the List, but that 
the relevant exposures would be limited to nighttime sleep disruption 
related to response and cleanup activities (including shiftwork). 
Accordingly, the WTC Health Program has only considered exposure to 
nighttime sleep disruption related to response and cleanup activities 
when certifying breast cancers for treatment in WTC responders and 
survivors.
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    \3\ Shiftwork involving circadian rhythm disruption has been 
classified by IARC as probably carcinogenic based in part on limited 
evidence in humans demonstrating an increased risk of breast cancer 
among shiftworkers who work at night. IARC notes that mechanistic 
studies suggest that exposure to light at night may increase the 
risk of breast cancer by suppressing the normal nocturnal production 
of melatonin, which in turn, may alter gene expression in cancer-
related pathways [Straif, et al. 2007]. NTP has not yet examined the 
evidence for an association of shiftwork and breast cancer, however, 
NTP recently requested comment from the public on whether shiftwork 
involving light at night should be nominated for possible review for 
future editions of the RoC. [NTP 2012] The Administrator was not 
aware of any published exposure assessment study of shiftwork and 9/
11, although the Administrator was aware that extended work hours 
for many responders occurred at all three 9/11 sites over several 
months. Thus the evidence supporting an association between 
shiftwork and breast cancer did not meet all of the requirements of 
Method 3; however, the Administrator felt the STAC's recommendation 
and support for an association between shiftwork and female breast 
cancer was sufficient to add breast cancer to the List of WTC-
Related Health Conditions based on Method 4.
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C. New Information on Breast Cancer and PCBs

    On March 15, 2013, the IARC Monograph Working Group announced a 
change in its classification of polychlorinated biphenyls (PCBs). 
According to the Working Group's article, published in The Lancet 
Oncology,\4\ a review of more than 70 epidemiological studies led IARC 
to determine that the studies provided limited evidence of increased 
risks for breast cancer for individuals with exposures to PCBs.\5\
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    \4\ Lauby-Secretan B, Loomis D, Grosse Y, El Ghissassi F, 
Bouvard V, Benbrahim-Tallaa L, Guha N, Baan R, Mattock H, Straif K 
(on behalf of IARC Monograph Working Group) [2013]. Carcinogenicity 
of Polychlorinated Biphenyls and Polybrominated Biphenyls. The 
Lancet Oncology 14(4):287-288.
    \5\ According to the Lancet article, the Working Group's 
assessments will be published as volume 107 of the IARC Monographs.
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    In reviewing this new information, the Administrator finds that all 
of the criteria in Method 3 supporting the addition of breast cancer to 
the List based on PCB exposures are now satisfied: PCBs 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); \6\ NTP identified PCBs as reasonably anticipated to be a 
human carcinogen \7\ and IARC has recently found limited evidence that 
PCBs cause breast cancer (Method 3B).
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    \6\ Butt CM, Diamond ML, Truong J, Ikonomou MG, Helm PA, Stern 
GA [2004]. Semivolatile organic compounds in window films from lower 
Manhattan after the September 11th World Trade Center attacks. 
Environmental Science & Technology. 38(13):3514-3524.
     Lorber M, Gibb H, Grant L, Pinto J, Pleil J, Cleverly D [2007]. 
Assessment of inhalation exposures and potential health risks to the 
general population that resulted from the collapse of the World 
Trade Center towers. Risk Anal 27(5):1203-21.
     Lioy PJ, Gochfeld M [2002]. Lessons learned on environmental, 
occupational, and residential exposures from the attack on the World 
Trade Center. Am J Ind Med 42(6):560-565.
    \7\ NTP (National Toxicology Program) [2011]. 12th Report on 
Carcinogens. National Toxicology Program, Public Health Service, 
U.S. Department of Health and Human Services, Research Triangle 
Park, NC. http://ntp.niehs.nih.gov/ntp/roc/twelfth/profiles/PolychlorinatedBiphenyls.pdf. Accessed March 28, 2013.
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    Consequently, the Administrator finds that PCB exposures associated 
with the 9/11 attacks (including response and remediation activities) 
qualify as another exposure basis--in addition to nighttime sleep 
disruption related to response and cleanup activities (including 
shiftwork)--for certifying a member's breast cancer for treatment.

D. Effect on Breast Cancer Coverage

    As a result of this finding by the Administrator, eligible 
responders and survivors who experienced the requisite exposure to 
either nighttime sleep disruption related to response and cleanup 
activities (including shiftwork) or PCBs (in dust and smoke) resulting 
from the 9/11 attacks may be certified for treatment of breast cancer.

    Dated: April 11, 2013.
John Howard,
Director, National Institute for Occupational Safety and Health, 
Centers for Disease Control and Prevention.
[FR Doc. 2013-09003 Filed 4-16-13; 8:45 am]
BILLING CODE 4163-19-P