22794 Federal Register / Vol. 78, No. 74 / Wednesday, April 17, 2013 / Rules and Regulations 

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

2STAC [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. 

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 

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]. 

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 


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Federal Register / Vol. 78, No. 74 / Wednesday, April 17, 2013 / Rules and Regulations 22795 

3Shiftwork 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. 

4Lauby-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. 

5According to the Lancet article, the Working 

Group’s assessments will be published as volume 

107 of the IARC Monographs. 

6Butt 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. 

7NTP (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. 

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. 

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 

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 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: 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: 

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 


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