World Trade Center Health Program; Certification of Breast Cancer in WTC Responders and Survivors Exposed to PCBs, 22794-22795 [2013-09003]

Download as PDF 22794 Federal Register / Vol. 78, No. 74 / Wednesday, April 17, 2013 / Rules and Regulations XI. Congressional Review Act Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: March 22, 2013. Steven Bradbury, Director, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES IN FOOD 1. The authority citation for part 180 continues to read as follows: ■ Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 180.1320 is added to subpart D to read as follows: ■ § 180.1320 Methyl jasmonate; exemption from the requirement of a tolerance. An exemption from the requirement of a tolerance is established for residues of methyl jasmonate in or on all food commodities when methyl jasmonate is applied pre-harvest. [FR Doc. 2013–08829 Filed 4–16–13; 8:45 am] BILLING CODE 6560–50–P 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 Centers for Disease Control and Prevention, HHS. ACTION: Change in certification requirements. AGENCY: 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 erowe on DSK2VPTVN1PROD with RULES SUMMARY: VerDate Mar<15>2010 15:11 Apr 16, 2013 Jkt 229001 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 pmiddendorf@cdc.gov. 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 1 See PO 00000 42 CFR 88.17(a)(2)(i). Frm 00028 Fmt 4700 Sfmt 4700 correct errors in Table 1 of the final rule (the list of cancers covered by the Program) [77 FR 62167]. 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 congenerspecific 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] 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 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, https://www.cdc.gov/niosh/ docket/archive/docket257.html. E:\FR\FM\17APR1.SGM 17APR1 Federal Register / Vol. 78, No. 74 / Wednesday, April 17, 2013 / Rules and Regulations 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. erowe on DSK2VPTVN1PROD with RULES 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 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 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. 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. VerDate Mar<15>2010 15:11 Apr 16, 2013 Jkt 229001 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). 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 ENVIRONMENTAL PROTECTION AGENCY 48 CFR Part 1552 [EPA–HQ–OARM–2012–0196; FRL–9800–6] EPAAR Clause for Printing Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: 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. https://ntp.niehs.nih.gov/ntp/roc/twelfth/ profiles/PolychlorinatedBiphenyls.pdf. Accessed March 28, 2013. PO 00000 Frm 00029 Fmt 4700 Sfmt 4700 22795 The Environmental Protection Agency (EPA) amends the EPA Acquisition Regulation (EPAAR) to update policy, procedures, and contract clauses. The final rule provides updates to outdated information previously in the EPAAR Printing clause. DATES: This final rule is effective on April 17, 2013. ADDRESSES: Docket: All documents in the docket are listed in the www.regulations.gov index. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available either electronically in www.regulations.gov, or in hard copy at the Office of Environmental Information (OEI) Docket, EPA/DC, EPA West, Room 3334, 1301 Constitution Ave. NW., Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566–1744, and the telephone number for the EPA Docket Center is (202) 566– 1752. This Docket Facility is open from 8:30 a.m. to 4:30 p.m. Monday through Friday, excluding legal holidays. FOR FURTHER INFORMATION CONTACT: Thomas Valentino, Policy, Training, and Oversight Division, Office of Acquisition Management (3802R), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number: 202–564– 4522; email address: valentino.thomas@epa.gov. SUPPLEMENTARY INFORMATION: SUMMARY: I. Background In 2011 the EPA reviewed EPAAR clause 1552.208–70, Printing. Review was performed to reconsider the electronic reproduction threshold under which vendors may provide contract deliverables without violating mandatory printing source requirements. Reconsideration of the reproduction threshold was warranted given the ease with which electronic media may be reproduced. The clause is also being updated to clarify that EPA’s Print Management Team is the processing office responsible for clause printing requirement waivers provided by the Joint Committee on Printing. Finally, the definition of non-paper copies that the contractor may provide has been expanded to include other types of portable electronic media in addition to compact discs. As such, the E:\FR\FM\17APR1.SGM 17APR1

Agencies

DEPARTMENT OF HEALTH AND HUMAN SERVICES

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


=======================================================================
-----------------------------------------------------------------------

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.

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

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 
pmiddendorf@cdc.gov.

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].
---------------------------------------------------------------------------

    \1\ See 42 CFR 88.17(a)(2)(i).
---------------------------------------------------------------------------

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]
---------------------------------------------------------------------------

    \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, https://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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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).
---------------------------------------------------------------------------

    \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. https://ntp.niehs.nih.gov/ntp/roc/twelfth/profiles/PolychlorinatedBiphenyls.pdf. Accessed March 28, 2013.
---------------------------------------------------------------------------

    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

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