Federal Register / Vol. 80, No. 72 / Wednesday, April 15, 2015 / Proposed Rules 20189 

b. How does a crew monitor and 

respond to changing weather 

conditions, including storms? 

20. Fatigue: OSHA believes that 

fatigue can affect communication tower 

workers in several ways. Climbing a 

communication tower is physically 

demanding, and OSHA is concerned 

that fatigue due to exertion can be 

hazardous for tower workers. 

Accelerated work timelines can also 

result in tower workers working very 

long hours. And OSHA understands that 

communication tower workers may 

travel long distances to reach remote 

worksites, which can result in workers 

being fatigued before they even begin 

work. 

a. What hazards are faced by a worker 

who finds it physically challenging to 

perform expected tasks, such as 

climbing a tower or performing a selfrescue? What impact can this have on 

other crew members? 

b. What are the common causes of 

worker fatigue at communication tower 

worksites? 

c. What are the effects of fatigue on 

tower worker safety, and what types of 

incidents occur as a result of worker 

fatigue? 

21. Other common hazards: 

a. What other hazards are present in 

communication tower work, and what 

types of incidents are resulting from 

those hazards? What can be done to 

protect employees from those hazards? 

b. What are some health and safety 

considerations involved in working 

with communications equipment 

installed on non-dedicated tower 

structures, such as water towers, 

buildings, silos, electrical transmission 

towers, etc.? 

Contracting and Work Oversight 

22. Describe your role in the contract 

chain and the key safety-related 

provisions typically included in your 

contracts. How do contracting parties 

oversee or enforce those provisions? 

What are the consequences if a party 

fails to fulfill those contractual 

requirements? 

23. What characteristics of past safety 

performance does your company use in 

selecting potential contractors and 

subcontractors? What safety-related 

criteria does your company use in this 

selection process? 

24. Are safety-related factors 

considered in determining whether to 

remove a contractor/subcontractor from 

an ongoing project or from future 

selection processes? If so, what specific 

factors are considered? 

25. What are the ways in which the 

multi-leveled contracting environment 

(i.e., where entities such as the carrier, 

tower owner, turfing vendor, 

subcontractor, and contractors hired by 

the subcontractor all have some role in 

the project) impacts employee safety at 

communication tower worksites? 

26. What practices might companies 

in the contracting chain adopt to 

encourage communication and 

coordination among employers at tower 

work sites? What obstacles stand in the 

way of communication and 

coordination between different parties 

in the contracting chain? 

Economic Issues 

27. The Agency seeks information on 

the number and size of firms that are 

engaged in communication tower work 

and on the number of employees 

employed by those firms. 

28. The Agency seeks information 

about wage and turnover rates for 

employees who work on 

communication towers. The Agency is 

also interested in information about the 

experience possessed by workers 

currently doing communication tower 

work. Are they usually experienced in 

this type of work? Are there many new 

or inexperienced employees working on 

communication towers? 

29. What types of equipment are used 

in tower work and how often is this 

equipment repaired and/or replaced? 

30. The Agency seeks information 

from all employers in the contracting 

chain about the extent to which 

employees directly engaged in tower 

work are covered by workers’ 

compensation and/or an employer 

liability insurance policy. 

Tower Design 

31. Can towers be designed and built 

with elevators for lifting personnel or 

materials? Can towers be built with 

booms or davits aloft to aid in hoisting 

materials? 

32. How would elevators or davits 

affect productivity/efficiency, e.g., the 

amount of time spent on the tower? 

How would elevators or davits address 

or cause any safety hazards at the site? 

For example, would elevators or davits 

address hazards related to employee 

fatigue? 

33. What are the industry standards 

for providing fall protection anchor 

points on new towers? 

Regulatory/Non-Regulatory Approaches 

34. What would be the advantages 

and disadvantages of an OSHA standard 

that covers both construction and 

maintenance activities on 

communication towers? 

35. What effects have the North 

Carolina and Michigan regulatory 

approaches had on work practices and 

climber safety in those states? 

36. Should an OSHA standard be 

limited to work performed on 

communication towers, or should it also 

cover towers used for other purposes? 

37. If OSHA does not initiate a 

dedicated rulemaking for work on 

communication towers, what other 

types of regulatory actions might be 

necessary and appropriate? 

38. What non-regulatory approaches 

could OSHA take to address hazards 

faced by employees working on 

communication towers? 

Authority and Signature 

This document was prepared under 

the direction of David Michaels, Ph.D., 

MPH, Assistant Secretary of Labor for 

Occupational Safety and Health, U.S. 

Department of Labor. It is issued 

pursuant to sections 3704 et seq., Public 

Law 107–217, 116 STAT. 1062 (40 

U.S.C. 3704 et seq.); sections 4, 6, and 

8, Public Law 91–596, 84 STAT. 1590 

(29 U.S.C. 653, 655, 657); 29 CFR part 

1911; and Secretary of Labor’s Order No. 

1–2012 (77 FR 3912 (Jan. 25, 2012)). 

Signed at Washington, DC, on March 27, 

2015. 

David Michaels, 

Assistant Secretary of Labor for Occupational 

Safety and Health. 

[FR Doc. 2015–08633 Filed 4–14–15; 8:45 am] 

BILLING CODE 4510–26–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 372 

[EPA–HQ–TRI–2015–0011; FRL–9925–29– 

OEI] 

RIN 2025–AA41 

Addition of 1-Bromopropane; 

Community Right-To-Know Toxic 

Chemical Release Reporting 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is proposing to add 1- 

bromopropane to the list of toxic 

chemicals subject to reporting under 

section 313 of the Emergency Planning 

and Community Right-to-Know Act 

(EPCRA) of 1986 and section 6607 of the 

Pollution Prevention Act (PPA) of 1990. 

1-Bromopropane has been classified by 

the National Toxicology Program in 

their 13th Report on Carcinogens as 

‘‘reasonably anticipated to be a human 

carcinogen.’’ EPA believes that 1- 

bromopropane meets the EPCRA section 

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20190 Federal Register / Vol. 80, No. 72 / Wednesday, April 15, 2015 / Proposed Rules 

313(d)(2)(B) criteria because it can 

reasonably be anticipated to cause 

cancer in humans. Based on a review of 

the available production and use 

information, 1-bromopropane is 

expected to be manufactured, processed, 

or otherwise used in quantities that 

would exceed the EPCRA section 313 

reporting thresholds. 

DATES: Comments must be received on 

or before June 15, 2015. 

ADDRESSES: Submit your comments, 

identified by Docket ID No. EPA–HQ– 

TRI–2015–0011, by one of the following 

methods: 

• www.regulations.gov: Follow the 

on-line instructions for submitting 

comments. 

• Email: oei.docket@epa.gov. 

• Mail: Office of Environmental 

Information (OEI) Docket, 

Environmental Protection Agency, Mail 

Code: 28221T, 1200 Pennsylvania Ave. 

NW., Washington, DC 20460. 

• Hand Delivery: EPA Docket Center 

(EPA/DC), EPA West, Room 3334, 1301 

Constitution Ave. NW., Washington, DC 

20460. Such deliveries are only 

accepted during the Docket’s normal 

hours of operation, and special 

arrangements should be made for 

deliveries of boxed information. 

Instructions: Direct your comments to 

Docket ID No. EPA–HQ–TRI–2015– 

0011. EPA’s policy is that all comments 

received will be included in the public 

docket without change and may be 

made available online at 

www.regulations.gov, including any 

personal information provided, unless 

the comment includes information 

claimed to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Do not submit information that you 

consider to be CBI or otherwise 

protected through www.regulations.gov 

or email. The www.regulations.gov Web 

site is an ‘‘anonymous access’’ system, 

which means EPA will not know your 

identity or contact information unless 

you provide it in the body of your 

comment. If you send an email 

comment directly to EPA without going 

through www.regulations.gov, your 

email address will be automatically 

captured and included as part of the 

comment that is placed in the public 

docket and made available on the 

Internet. If you submit an electronic 

comment, EPA recommends that you 

include your name and other contact 

information in the body of your 

comment and with any disk or CD–ROM 

you submit. If EPA cannot read your 

comment due to technical difficulties 

and cannot contact you for clarification, 

EPA may not be able to consider your 

comment. Electronic files should avoid 

the use of special characters, avoid any 

form of encryption, and be free of any 

defects or viruses. 

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 OEI Docket, EPA/DC, EPA West, 

Room 3334, 1301 Constitution Ave. 

NW., Washington, DC. This Docket 

Facility 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 OEI Docket is (202) 566–1752. 

FOR FURTHER INFORMATION CONTACT: 

Daniel R. Bushman, Environmental 

Analysis Division, Office of Information 

Analysis and Access (2842T), 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460; telephone number: 202–566– 

0743; fax number: 202–566–0677; email: 

bushman.daniel@epa.gov, for specific 

information on this notice. For general 

information on EPCRA section 313, 

contact the Emergency Planning and 

Community Right-to-Know Hotline, toll 

free at (800) 424–9346 (select menu 

option 3) or (703) 412–9810 in Virginia 

and Alaska or toll free, TDD (800) 553– 

7672, http://www.epa.gov/superfund/

contacts/infocenter/. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this notice apply to me? 

You may be potentially affected by 

this action if you manufacture, process, 

or otherwise use 1-bromopropane. 

Potentially affected categories and 

entities may include, but are not limited 

to: 

Category Examples of potentially affected entities 

Industry ....................... Facilities included in the following NAICS manufacturing codes (corresponding to SIC codes 20 through 39): 311 *, 

312 *, 313 *, 314 *, 315 *, 316, 321, 322, 323 *, 324, 325 *, 326 *, 327, 331, 332, 333, 334 *, 335 *, 336, 337 *, 339 *, 

111998 *, 211112 *, 212324 *, 212325 *, 212393 *, 212399 *, 488390 *, 511110, 511120, 511130, 511140 *, 511191, 

511199, 512220, 512230 *, 519130 *, 541712 *, or 811490 *. 

* Exceptions and/or limitations exist for these NAICS codes. 

Facilities included in the following NAICS codes (corresponding to SIC codes other than SIC codes 20 through 39): 

212111, 212112, 212113 (correspond to SIC 12, Coal Mining (except 1241)); or 212221, 212222, 212231, 212234, 

212299 (correspond to SIC 10, Metal Mining (except 1011, 1081, and 1094)); or 221111, 221112, 221113, 221119, 

221121, 221122, 221330 (Limited to facilities that combust coal and/or oil for the purpose of generating power for 

distribution in commerce) (corresponds to SIC 4911, 4931, and 4939, Electric Utilities); or 424690, 425110, 425120 

(Limited to facilities previously classified in SIC 5169, Chemicals and Allied Products, Not Elsewhere Classified); or 

424710 (corresponds to SIC 5171, Petroleum Bulk Terminals and Plants); or 562112 (Limited to facilities primarily 

engaged in solvent recovery services on a contract or fee basis (previously classified under SIC 7389, Business 

Services, NEC)); or 562211, 562212, 562213, 562219, 562920 (Limited to facilities regulated under the Resource 

Conservation and Recovery Act, subtitle C, 42 U.S.C. 6921 et seq.) (corresponds to SIC 4953, Refuse Systems). 

Federal Government .. Federal facilities. 

This table is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Some of the 

entities listed in the table have 

exemptions and/or limitations regarding 

coverage, and other types of entities not 

listed in the table could also be affected. 

To determine whether your facility 

would be affected by this action, you 

should carefully examine the 

applicability criteria in part 372 subpart 

B of Title 40 of the Code of Federal 

Regulations. If you have questions 

regarding the applicability of this action 

to a particular entity, consult the person 

listed in the preceding FOR FURTHER

INFORMATION CONTACT section. 

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II. Introduction 

A. What is the statutory authority for 

this proposed rule? 

This rule is issued under EPCRA 

section 313(d) and section 328, 42 

U.S.C. 11023 et seq. EPCRA is also 

referred to as Title III of the Superfund 

Amendments and Reauthorization Act 

of 1986. 

B. What is the background for this 

action? 

Section 313 of EPCRA, 42 U.S.C. 

11023, requires certain facilities that 

manufacture, process, or otherwise use 

listed toxic chemicals in amounts above 

reporting threshold levels to report their 

environmental releases and other waste 

management quantities of such 

chemicals annually. These facilities 

must also report pollution prevention 

and recycling data for such chemicals, 

pursuant to section 6607 of the PPA, 42 

U.S.C. 13106. Congress established an 

initial list of toxic chemicals that 

comprised 308 individually listed 

chemicals and 20 chemical categories. 

EPCRA section 313(d) authorizes EPA 

to add or delete chemicals from the list 

and sets criteria for these actions. 

EPCRA section 313(d)(2) states that EPA 

may add a chemical to the list if any of 

the listing criteria in Section 313(d)(2) 

are met. Therefore, to add a chemical, 

EPA must demonstrate that at least one 

criterion is met, but need not determine 

whether any other criterion is met. 

Conversely, to remove a chemical from 

the list, EPCRA section 313(d)(3) 

dictates that EPA must demonstrate that 

none of the listing criteria in Section 

313(d)(2)(A) through (C) are met. The 

EPCRA section 313(d)(2)(A) through (C) 

criteria are: 

• The chemical is known to cause or 

can reasonably be anticipated to cause 

significant adverse acute human health 

effects at concentration levels that are 

reasonably likely to exist beyond facility 

site boundaries as a result of 

continuous, or frequently recurring, 

releases. 

• The chemical is known to cause or 

can reasonably be anticipated to cause 

in humans: 

Æ Cancer or teratogenic effects; or 

Æ Serious or irreversible— 

D Reproductive dysfunctions, 

D Neurological disorders, 

D Heritable genetic mutations; or 

D Other chronic health effects. 

• The chemical is known to cause or 

can be reasonably anticipated to cause, 

because of: 

Æ Its toxicity; 

Æ Its toxicity and persistence in the 

environment; or 

Æ Its toxicity and tendency to 

bioaccumulate in the environment, a 

significant adverse effect on the 

environment of sufficient seriousness, 

in the judgment of the Administrator, to 

warrant reporting under this section. 

EPA often refers to the section 

313(d)(2)(A) criterion as the ‘‘acute 

human health effects criterion;’’ the 

section 313(d)(2)(B) criterion as the 

‘‘chronic human health effects 

criterion;’’ and the section 313(d)(2)(C) 

criterion as the ‘‘environmental effects 

criterion.’’ 

EPA published in the Federal 

Register of November 30, 1994 (59 FR 

61432), a statement clarifying its 

interpretation of the section 313(d)(2) 

and (d)(3) criteria for modifying the 

section 313 list of toxic chemicals. 

III. Background Information 

A. What is the NTP and the report on 

carcinogens? 

The National Toxicology Program 

(NTP) is an interagency program within 

the Department of Health and Human 

Services (DHHS) headquartered at the 

National Institute of Environmental 

Health Sciences (NIEHS) of the National 

Institutes of Health (NIH). The mission 

of the NTP is to evaluate chemicals of 

public health concern by developing 

and applying tools of modern toxicology 

and molecular biology. The NTP 

program maintains an objective, 

science-based approach in dealing with 

critical issues in toxicology and is 

committed to using the best science 

available to prioritize, design, conduct, 

and interpret its studies. The mission of 

the NTP includes the evaluation of 

chemicals for their potential to cause 

cancer in humans. 

As part of their cancer evaluation 

work, the NTP periodically publishes a 

Report on Carcinogens (RoC) document. 

The RoC was mandated by the U.S. 

Congress, as part of the Public Health 

Service Act (Section 301(b)(4), as 

amended). The NTP describes the RoC 

as an informational scientific and public 

health document that identifies and 

discusses agents, substances, mixtures, 

or exposure circumstances that may 

pose a hazard to human health by virtue 

of their carcinogenicity. The NTP RoC 

serves as a meaningful and useful 

compilation of data on (1) the 

carcinogenicity (ability to cause cancer), 

genotoxicity (ability to damage genes), 

and biologic mechanisms (modes of 

action in the body) of the RoC-listed 

substances in humans and/or in 

animals, (2) the potential for human 

exposure to these substances, and (3) 

the regulations and guidelines 

promulgated by Federal agencies to 

limit exposures to RoC-listed 

substances. The NTP RoC is published 

periodically, with the most recently 

published 13th RoC having been 

released on October 2, 2014 (79 FR 

60169, October 6, 2014). The 13th RoC 

contains the NTP cancer classifications 

from the most recent chemical 

evaluations, as well as the 

classifications from previous versions of 

the RoC (Reference (Ref.) 1). 

B. What are the NTP cancer 

classifications and criteria? 

The NTP RoC classifies chemicals as 

either ‘‘known to be a human 

carcinogen’’ or ‘‘reasonably anticipated 

to be a human carcinogen.’’ The criteria 

that the NTP uses to list an agent, 

substance, mixture, or exposure 

circumstance under each classification 

in the RoC (Ref. 2) are as follows: 

Known To Be Human Carcinogen: There is 

sufficient evidence of carcinogenicity from 

studies in humans *, which indicates a causal 

relationship between exposure to the agent, 

substance, or mixture, and human cancer. 

Reasonably Anticipated To Be Human 

Carcinogen: There is limited evidence of 

carcinogenicity from studies in humans *, 

which indicates that causal interpretation is 

credible, but that alternative explanations, 

such as chance, bias, or confounding factors, 

could not adequately be excluded, or there is 

sufficient evidence of carcinogenicity from 

studies in experimental animals, which 

indicates there is an increased incidence of 

malignant and/or a combination of malignant 

and benign tumors (1) in multiple species or 

at multiple tissue sites, or (2) by multiple 

routes of exposure, or (3) to an unusual 

degree with regard to incidence, site, or type 

of tumor, or age at onset, or there is less than 

sufficient evidence of carcinogenicity in 

humans or laboratory animals; however, the 

agent, substance, or mixture belongs to a 

well-defined, structurally related class of 

substances whose members are listed in a 

previous Report on Carcinogens as either 

known to be a human carcinogen or 

reasonably anticipated to be a human 

carcinogen, or there is convincing relevant 

information that the agent acts through 

mechanisms indicating it would likely cause 

cancer in humans. 

Conclusions regarding carcinogenicity in 

humans or experimental animals are based 

on scientific judgment, with consideration 

given to all relevant information. Relevant 

information includes, but is not limited to, 

dose response, route of exposure, chemical 

structure, metabolism, pharmacokinetics, 

sensitive sub-populations, genetic effects, or 

other data relating to mechanism of action or 

factors that may be unique to a given 

substance. For example, there may be 

substances for which there is evidence of 

carcinogenicity in laboratory animals, but 

there are compelling data indicating that the 

agent acts through mechanisms which do not 

operate in humans and would therefore not 

reasonably be anticipated to cause cancer in 

humans. 

* This evidence can include traditional 

cancer epidemiology studies, data from 

clinical studies, and/or data derived from the 

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study of tissues or cells from humans 

exposed to the substance in question, which 

can be useful for evaluating whether a 

relevant cancer mechanism is operating in 

humans. 

The NTP classifications for the 

potential for a chemical to cause cancer 

are very similar to the EPCRA section 

313(d)(2)(B) statutory criteria for listing 

a chemical on the list of toxic chemicals 

subject to reporting under EPCRA 

section 313: ‘‘(B) The chemical is known 

to cause or can reasonably be 

anticipated to cause in humans—(i) 

cancer . . .’’ The specific data used by 

the NTP to classify a chemical as 

‘‘Known To Be Human Carcinogen’’ or 

‘‘Reasonably Anticipated To Be Human 

Carcinogen’’ are consistent with data 

used by EPA to evaluate chemicals for 

their potential to cause cancer and 

classify chemicals as either 

‘‘Carcinogenic to Humans’’ or ‘‘Likely to 

Be Carcinogenic to Humans’’ (Ref. 3). 

C. What is the review process for the 

RoC? 

Specific details of the nomination and 

review process for the development of 

the 13th RoC are described in the 

Process for Preparation of the Report on 

Carcinogens section of the 13th RoC 

(Ref. 4). In general, the RoC review 

process includes evaluations by 

scientists from the NTP, other Federal 

health research and regulatory agencies 

(including EPA), and nongovernmental 

institutions. The RoC review process 

includes external peer review and 

several opportunities for public 

comment. For the 13th RoC, during the 

entire nomination, selection, and review 

process there were seven opportunities 

for public comment. For each candidate 

substance, an expert panel was 

convened to peer review the NTP 

monograph document prepared for each 

candidate substance. The RoC 

Monograph on 1-Bromopropane consists 

of the following components: (Part 1) 

the cancer evaluation component that 

reviews the relevant scientific 

information, assesses its quality, applies 

the RoC listing criteria to the scientific 

information, and gives the RoC listing 

status for 1-bromopropane, and (Part 2) 

the RoC monograph’s substance profile 

containing the NTP’s listing status 

decision, a summary of the scientific 

evidence considered key to reaching 

that decision, and data on properties, 

use, production, exposure, and Federal 

regulations and guidelines to reduce 

exposure to 1-bromopropane. The 

expert panel members had the following 

major responsibilities in reviewing the 

draft RoC monograph: 

(1) to comment on the draft cancer 

evaluation components for 1-bromopropane, 

specifically, whether they are technically 

correct and clearly stated, whether the NTP 

has objectively presented and assessed the 

scientific evidence, and whether the 

scientific evidence is adequate for applying 

the RoC listing criteria, and (2) to comment 

on the draft substance profile for 1- 

bromopropane, specifically, whether the 

scientific justification presented in the 

substance profile supports the NTP’s 

preliminary policy decision on the RoC 

listing status of 1-bromopropane. The panel 

was also asked to vote on the following 

questions: (1) Whether the scientific evidence 

supports the NTP’s conclusion on the level 

of evidence for carcinogenicity from 

experimental animal studies on 1- 

bromopropane and (2) whether the scientific 

evidence supports the NTP’s preliminary 

listing decision for 1-bromopropane in the 

RoC. The panel agreed with the NTP 

conclusions that 1-bromopropane should be 

listed in the RoC based on sufficient evidence 

of carcinogenicity from studies in 

experimental animals, which found skin 

tumors in male rats, large intestine tumors in 

female and male rats, and lung tumors in 

female mice.’’ (Ref. 5) 

Based upon the peer-review comments, 

the Office of the Report on Carcinogens 

(ORoC) prepared a revised draft RoC 

Monograph, which was then reviewed 

by the NTP Board of Scientific 

Counselors. The ORoC, in concert with 

the NTP Director, then finalized the RoC 

monographs and submitted the newly 

reviewed substances to the NTP 

Executive Committee for consultation. 

The final draft of the 13th RoC was then 

submitted to the Secretary of Health and 

Human Services (HHS) for review and 

approval. Once approved, the Secretary 

submitted the 13th RoC to the U.S. 

Congress as a final document and 

published the document on the RoC 

Web site (http://ntp.niehs.nih.gov/

pubhealth/roc/roc13/index.html). 

IV. EPA’s Review of the 13th RoC 

A. How did EPA select the NTP RoC 

chemical being proposed for addition? 

The most recent version of the NTP 

RoC that EPA previously reviewed for 

possible additions to the EPCRA section 

313 list was the 12th RoC (March 13, 

2013, 78 FR 15913). Each new version 

of the RoC adds newly classified 

chemicals to the existing list. EPA’s 

present review of the 13th RoC 

identified 1-bromopropane as the only 

newly listed chemical that is not on the 

EPCRA section 313 list. 

EPA reviewed the NTP 13th RoC 

chemical profile and supporting 

materials for 1-bromopropane (Ref. 6). 

Given the extensive scientific reviews 

conducted by the NTP for their RoC 

documents, EPA’s review focused on 

ensuring that there were no 

inconsistencies with how the Agency 

would consider the available data. 

EPA’s review of the 1-bromopropane 

chemical profile and supporting 

material found no inconsistencies 

between how the data were interpreted 

by the NTP and how that same data 

would be interpreted under EPA’s 

Guidelines for Carcinogen Risk 

Assessment (Ref. 3). Therefore, EPA 

agrees with the hazard conclusions of 

the NTP 13th RoC for 1-bromopropane. 

B. What technical data supports the 

NTP RoC classification and EPA’s 

proposed addition of 1-bromopropane 

to the EPCRA section 313 list? 

This section presents the data that 

supported the NTP 13th RoC 

classification of 1-bromopropane and 

why EPA believes the data support the 

addition of this chemical to the EPCRA 

section 313 list. The RoC 1- 

Bromopropane Profile document (Ref. 

7), the RoC Monograph on 1- 

Bromopropane (Ref. 5), and the 

available references cited within the 

portion of the 13th RoC chemical profile 

quoted here, are all included in the 

docket for this rulemaking. While they 

are contained in the docket and are part 

of the rulemaking record, the references 

within the quotation cited below from 

the 13th RoC 1-Bromopropane Profile 

document are not included in the list of 

references in Unit VI. of this Federal 

Register notice. The full citations for the 

references contained in the quotation 

can be found in the NTP 13th RoC 1- 

Bromopropane Profile document (Ref. 

7). 

1. 1-Bromopropane (Chemical 

Abstracts Service Registry Number 106– 

94–5) (Refs. RoC Monograph and Profile 

documents (Refs. 5 and 7)). The NTP 

has classified 1-bromopropane as 

‘‘reasonably anticipated to be a human 

carcinogen.’’ The classification is based 

on sufficient evidence of carcinogenicity 

in experimental animals and supporting 

data on mechanisms of carcinogenesis. 

The RoC substance profile for 1- 

bromopropane (Ref. 7) included the 

following summary information of the 

evidence of carcinogenicity: 

Carcinogenicity 

1-Bromopropane is reasonably anticipated 

to be a human carcinogen based on sufficient 

evidence of carcinogenicity from studies in 

experimental animals. 1-Bromopropane, 

either directly or via reactive metabolites, 

causes molecular alterations that typically 

are associated with carcinogenesis, including 

genotoxicity, oxidative stress, and 

glutathione depletion. These alterations, 

observed mainly in vitro and in toxicity 

studies in rodents, are relevant to possible 

mechanisms of human carcinogenicity and 

support the relevance of the cancer studies in 

experimental animals to human 

carcinogenicity. 

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Cancer Studies in Experimental Animals 

Inhalation exposure to 1-bromopropane 

caused tumors in two rodent species and at 

several different tissue sites, including one 

tissue site in rats at which tumors are rare 

(NTP 2011). 

In male rats, 1-bromopropane caused 

significant dose-related increases in the 

incidences of several types of benign and/or 

malignant skin tumors (keratoacanthoma; 

keratoacanthoma and squamous-cell 

carcinoma combined; and keratoacanthoma, 

squamous-cell carcinoma, basal-cell 

adenoma, and basal-cell carcinoma 

combined). Both female and male rats 

showed an increased incidence of largeintestine tumors (adenoma of the colon and 

rectum), which are rare tumors in rats. In 

females, the incidence was dose-related and 

statistically significantly higher than in 

concurrent controls, and it exceeded the 

historical control range for all routes of 

exposure used in studies, including 

inhalation exposure. In males, the incidence 

of large-intestine adenoma was not 

significantly increased, but exceeded the 

historical control range for inhalationexposure studies, and its occurrence was 

considered to be biologically significant 

because of the rarity of these tumors (which 

occurred in less than 0.2% of the historical 

controls). Although no carcinoma of the large 

intestine was observed in male or female rats 

in this study, adenoma of the large intestine 

has been shown to progress to carcinoma in 

other studies, and forms a morphologic 

continuum with carcinoma (Deschner 1983, 

Chang 1984, Nigro 1985). 

In female mice, 1-bromopropane caused 

significant dose-related increases in the 

incidence of benign and malignant lung 

tumors combined (alveolar/bronchiolar 

adenoma and carcinoma). 

These findings are supported by the 

observation of additional tumors in rats that 

may have been related to 1-bromopropane 

exposure, including malignant mesothelioma 

of the abdominal cavity and pancreatic islet 

tumors in males and skin tumors (squamouscell papilloma, keratoacanthoma, and basalcell adenoma or carcinoma) in females. 

Other Relevant Data 

1-Bromopropane is well absorbed 

following ingestion, inhalation, or dermal 

exposure. Occupational exposure occurs 

primarily by inhalation and dermal contact. 

Unmetabolized 1-bromopropane has been 

detected in the urine of exposed workers at 

levels significantly correlated with exposure 

to 1-bromopropane in air (Kawai et al. 2001, 

Ichihara et al. 2004). 

1-Bromopropane is metabolized via several 

pathways; 16 urinary metabolites have been 

detected in rodents, and several other 

metabolites have been proposed (Jones and 

Walsh 1979, Ishidao et al. 2002, Garner et al. 

2006). The primary metabolic pathways in 

rodents are oxidation reactions catalyzed by 

cytochrome P450 (primarily CYP2E1) and 

glutathione conjugation. The available data 

on human metabolism of 1-bromopropane, 

although limited, suggest that some of its 

metabolic pathways in humans are similar to 

those observed in rodents. Four mercapturic 

conjugates identified in the urine of rodents 

were also identified in the urine of workers 

exposed to 1-bromopropane (Hanley et al. 

2009). The major metabolite, N-acetyl-S-(npropyl)-L-cysteine, has been detected in the 

urine of exposed workers at levels that 

increased with increasing levels of 1- 

bromopropane in ambient air (Hanley and 

Dunn 2006, Valentine et al. 2007, Hanley et 

al. 2009, 2010). This metabolite is produced 

in humans by conjugation of 1-bromopropane 

with glutathione, and that reaction also 

releases free bromide ions, another useful 

biomarker for human exposure to 1- 

bromopropane (Jones and Walsh 1979, 

Hanley et al. 2006). No studies were 

identified that tested for the occurrence in 

humans of the oxidative metabolites that are 

obligate intermediates to the measured 

conjugates. 

Studies on Mechanisms of Carcinogenesis 

The mechanism(s) by which 1- 

bromopropane causes cancer is not known. 

However, exposure to 1-bromopropane has 

been shown to cause molecular alterations 

related to carcinogenicity, including 

genotoxicity (mutations and DNA damage), 

oxidative stress, glutathione depletion, and 

immunomodulation. 

Studies have shown that 1-bromopropane 

can bind to macromolecules; it formed Spropylcysteine–globin adducts in exposed 

animals and humans (Valentine et al. 2007). 

Although 1-bromopropane did not induce 

mutations in bacteria under standard assay 

conditions, it did induce mutations in 

bacteria both with and without exogenous 

mammalian metabolic activation in the only 

reported study whose design was appropriate 

for testing a highly volatile chemical (Barber 

et al. 1981). It also caused mutations in 

cultured mammalian cells with or without 

mammalian metabolic activation (Elf 

Atochem 1996, as reviewed in NTP 2003) 

and DNA damage in cultured human cells 

without metabolic activation (Toraason et al. 

2006). In addition, there is limited evidence 

of DNA damage in leukocytes from 1- 

bromopropane-exposed workers (Toraason et 

al. 2006). In rodents exposed in vivo, 1- 

bromopropane did not increase micronucleus 

formation in bone marrow (Kim et al. 1998, 

as reviewed in NTP 2003) or peripheral blood 

erythrocytes (Elf Atochem 1996, cited in NTP 

2003, NTP 2011) or cause dominant lethal 

mutations. However, the dominant lethal 

mutation assay is generally regarded as 

relatively insensitive for the detection of 

mutagenic agents (Saito-Suzuki et al. 1982, 

Yu et al. 2008). 

There is evidence that metabolic activation 

plays a role in the genotoxicity and toxicity 

of 1-bromopropane. Several reactive 

metabolites (or intermediates) of 1- 

bromopropane have been identified in 

rodents, including glycidol and abromohydrin, and propylene oxide has been 

proposed as a metabolite (Garner et al. 2006). 

These compounds cause genotoxic effects in 

vitro, including DNA adduct formation, 

mutations, and DNA or chromosome damage 

(Stolzenberg and Hine 1979, IARC 1994, 

2000). Glycidol and propylene oxide cause 

cytogenetic effects in vivo and are 

carcinogenic in experimental animals, and 

both substances are listed in the Report on 

Carcinogens as reasonably anticipated to be 

human carcinogens. These reactive and 

genotoxic metabolites may be responsible for 

at least some of the carcinogenic effects of 1- 

bromopropane. As with 1-bromopropane, 

oral exposure to glycidol caused rare tumors 

of the large intestine in rats, as did oral 

exposure to two halogenated alkane 

analogues of 1-bromopropane, 

tribromomethane and bromodichloromethane 

(NTP 1987, 1989, 1990). 

Chronic exposure to 1-bromopropane may 

produce levels of oxidative metabolites that 

exceed the glutathione-conjugating capacity 

or may inhibit enzymes required for 

glutathione synthesis. Because glutathione is 

an important cellular defense mechanism, 

reduced levels can lead to oxidative stress, 

increased toxicity, and carcinogenicity. 

Numerous studies have shown that 1- 

bromopropane induces both oxidative stress 

and glutathione depletion (Lee et al. 2005, 

2007, 2010a, Liu et al. 2009, 2010, Huang et 

al. 2011). Studies with Cyp2e1–/– knockout 

mice, cytochrome P450 inhibitors, or a 

glutathione synthesis inhibitor showed that 

this metabolic activation pathway is involved 

in 1-bromopropane-induced toxicity, 

including neurological and reproductive 

effects, hepatotoxicity, and 

immunosuppression (NTP 2003, 2011, Lee et 

al. 2007, 2010a,b). Neurological effects of 1- 

bromopropane exposure have also been 

reported in humans (Li et al. 2010, Ichihara 

et al. 2012). 

It is unclear whether induction of 

immunotoxicity by 1-bromopropane plays a 

role in tumor development. Recent studies 

have shown that 1-bromopropane causes 

immunosuppression in rodents (Lee et al. 

2007, Anderson et al. 2010). In particular, it 

reduced the numbers of T cells and T-cell 

subpopulations. In addition, there is 

evidence that 1-bromopropane causes an 

inflammatory response. It induced doserelated increases in gene expression and 

production of proinflammatory cytokines in 

mouse macrophages (Han et al. 2008) and an 

inflammatory response in rats (NTP 2011). 

However, chronic respiratory inflammation 

and lung tumors were not associated in 

rodents; respiratory inflammation occurred 

in rats but not mice, whereas lung tumors 

occurred in mice but not rats. 

Cancer Studies in Humans 

No epidemiological studies or case reports 

were identified that evaluated the 

relationship between human cancer and 

exposure specifically to 1-bromopropane. 

EPA has reviewed the NTP 

assessment for 1-bromopropane and 

agrees that 1-bromopropane can 

reasonably be anticipated to cause 

cancer in humans. EPA believes that the 

evidence is sufficient for listing 1- 

bromopropane on EPCRA section 313 

pursuant to EPCRA section 313(d)(2)(B) 

based on the available carcinogenicity 

data for this chemical. 

V. Rationale for Listing 

The NTP RoC document undergoes 

significant scientific review and public 

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20194 Federal Register / Vol. 80, No. 72 / Wednesday, April 15, 2015 / Proposed Rules 

comment. The NTP review mirrors the 

review EPA has historically done to 

assess chemicals for listing under 

EPCRA section 313 on the basis of 

carcinogenicity. The conclusions 

regarding the potential for chemicals in 

the NTP RoC to cause cancer in humans 

are based on established sound 

scientific principles. EPA believes that 

the NTP RoC is an excellent and reliable 

source of information on the potential 

for chemicals covered in the NTP RoC 

to cause cancer in humans (see Unit III). 

Based on EPA’s review of the data 

contained in the NTP 13th RoC, EPA 

has determined that 1-bromopropane 

can reasonably be anticipated to cause 

cancer (Ref. 6). Therefore, EPA believes 

that the evidence is sufficient for listing 

1-bromopropane on the EPCRA section 

313 toxic chemical list pursuant to 

EPCRA section 313(d)(2)(B) based on 

the available carcinogenicity data 

presented in the NTP 13th RoC. 

EPA considers chemicals that can 

reasonably be anticipated to cause 

cancer to have moderately high to high 

chronic toxicity. EPA does not believe 

that it is appropriate to consider 

exposure for chemicals that are 

moderately high to highly toxic based 

on a hazard assessment when 

determining if a chemical can be added 

for chronic effects pursuant to EPCRA 

section 313(d)(2)(B) (see 59 FR 61440– 

61442). Therefore, in accordance with 

EPA’s standard policy on the use of 

exposure assessments (59 FR 61432), 

EPA does not believe that an exposure 

assessment is necessary or appropriate 

for determining whether 1- 

bromopropane meets the criteria of 

EPCRA section 313(d)(2)(B). 

VI. References 

EPA has established an official public 

docket for this action under Docket ID 

No. EPA–HQ–TRI–2015–0011. The 

public docket includes information 

considered by EPA in developing this 

action, including the documents listed 

below, which are electronically or 

physically located in the docket. In 

addition, interested parties should 

consult documents that are referenced 

in the documents that EPA has placed 

in the docket, regardless of whether 

these referenced documents are 

electronically or physically located in 

the docket. For assistance in locating 

documents that are referenced in 

documents that EPA has placed in the 

docket, but that are not electronically or 

physically located in the docket, please 

consult the person listed in the above 

FOR FURTHER INFORMATION CONTACT

section. For convenience, the docket 

also includes all of the Federal Register 

documents cited in this action. 

1. NTP, 2014. National Toxicology Program. 

Report on Carcinogens, Thirteenth 

Edition. Released October 2, 2014. U.S. 

Department of Health and Human 

Services, Public Health Service, National 

Toxicology Program, Research Triangle 

Park, NC 27709. (http://ntp.niehs.nih.

gov/pubhealth/roc/roc13/index.html) 

2. NTP, 2014. National Toxicology Program. 

Report on Carcinogens, Thirteenth 

Edition, Introduction section. Released 

October 2, 2014. U.S. Department of 

Health and Human Services, Public 

Health Service, National Toxicology 

Program, Research Triangle Park, NC 

27709. 

3. USEPA. Guidelines for Carcinogen Risk 

Assessment. Risk Assessment Forum, 

U.S. Environmental Protection Agency, 

Washington, DC, March 2005. 

4. NTP, 2014. National Toxicology Program. 

Report on Carcinogens, Thirteenth 

Edition, Process for Preparation of the 

Report on Carcinogens section. Released 

October 2, 2014. U.S. Department of 

Health and Human Services, Public 

Health Service, National Toxicology 

Program, Research Triangle Park, NC 

27709. 

5. NTP, 2013. Report on Carcinogens 

Monograph on 1-Bromopropane. Office 

of the Report on Carcinogens, Division of 

the National Toxicology Program, 

National Institute of Environmental 

Health Sciences, U.S. Department of 

Health and Human Services. NIH 

Publication No. 13–5982, September 25, 

2013 

6. USEPA, OEI. Memorandum from Jocelyn 

Hospital, Toxicologist, Analytical 

Support Branch to Sandra Gaona, Acting 

Chief, Analytical Support Branch. 

November 3, 2014. Subject: Review of 

National Toxicology Program (NTP) 

Cancer Classification Data for 1- 

bromopropane. 

7. NTP, 2014. National Toxicology Program. 

Report on Carcinogens, Thirteenth 

Edition, Profile for 1-Bromopropane. 

Released October 2, 2014. U.S. 

Department of Health and Human 

Services, Public Health Service, National 

Toxicology Program, Research Triangle 

Park, NC 27709. 

8. USEPA, OEI. Economic Analysis of the 

Proposed Rule to add 1-Bromopropane to 

the EPCRA Section 313 List of Toxic 

Chemicals. February 17, 2015. 

VII. What are the Statutory and 

Executive Order reviews associated 

with this action? 

A. Executive Order 12866: Regulatory 

Planning and Review and Executive 

Order 13563: Improving Regulation and 

Regulatory Review 

This action is not a significant 

regulatory action and was therefore not 

submitted to the Office of Management 

and Budget (OMB) for review. 

B. Paperwork Reduction Act 

This action does not contain any new 

information collection requirements that 

require additional approval by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act (PRA). OMB has previously 

approved the information collection 

activities contained in the existing 

regulations and has assigned OMB 

control numbers 2025–0009 and 2050– 

0078. Currently, the facilities subject to 

the reporting requirements under 

EPCRA 313 and PPA 6607 may use 

either the EPA Toxic Chemicals Release 

Inventory Form R (EPA Form 1B9350– 

1), or the EPA Toxic Chemicals Release 

Inventory Form A (EPA Form 1B9350- 

2). The Form R must be completed if a 

facility manufactures, processes, or 

otherwise uses any listed chemical 

above threshold quantities and meets 

certain other criteria. For the Form A, 

EPA established an alternative threshold 

for facilities with low annual reportable 

amounts of a listed toxic chemical. A 

facility that meets the appropriate 

reporting thresholds, but estimates that 

the total annual reportable amount of 

the chemical does not exceed 500 

pounds per year, can take advantage of 

an alternative manufacture, process, or 

otherwise use threshold of 1 million 

pounds per year of the chemical, 

provided that certain conditions are 

met, and submit the Form A instead of 

the Form R. In addition, respondents 

may designate the specific chemical 

identity of a substance as a trade secret 

pursuant to EPCRA section 322, 42 

U.S.C. 11042, 40 CFR part 350. 

OMB has approved the reporting and 

recordkeeping requirements related to 

Forms A and R, supplier notification, 

and petitions under OMB Control 

number 2025–0009 (EPA Information 

Collection Request (ICR) No. 1363) and 

those related to trade secret designations 

under OMB Control 2050–0078 (EPA 

ICR No. 1428). As provided in 5 CFR 

1320.5(b) and 1320.6(a), an Agency may 

not conduct or sponsor, and a person is 

not required to respond to, a collection 

of information unless it displays a 

currently valid OMB control number. 

The OMB control numbers relevant to 

EPA’s regulations are listed in 40 CFR 

part 9, 48 CFR chapter 15, and 

displayed on the information collection 

instruments (e.g., forms, instructions). 

C. Regulatory Flexibility Act (RFA), as 

Amended by the Small Business 

Regulatory Enforcement Fairness Act of 

1996 (SBREFA), 5 U.S.C. 601 et seq. 

I certify that this action will not have 

a significant economic impact on a 

substantial number of small entities 

under the RFA. The Agency has 

determined that of the 140 entities 

estimated to be impacted by this action, 

136 are small businesses; no small 

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Federal Register / Vol. 80, No. 72 / Wednesday, April 15, 2015 / Proposed Rules 20195 

governments or small organizations are 

expected to be affected by this action. 

All 136 small businesses affected by this 

action are estimated to incur annualized 

cost impacts of less than 1%. Facilities 

eligible to use Form A (those meeting 

the appropriate activity threshold which 

have 500 pounds per year or less of 

reportable amounts of the chemical) will 

have a lower burden. Thus, this action 

is not expected to have a significant 

adverse economic impact on a 

substantial number of small entities. A 

more detailed analysis of the impacts on 

small entities is located in EPA’s 

economic analysis support document 

(Ref. 8). 

D. Unfunded Mandates Reform Act 

This action does not contain an 

unfunded mandate of $100 million or 

more as described in UMRA, 2 U.S.C. 

1531 through 1538, and does not 

significantly or uniquely affect small 

governments. This action is not subject 

to the requirements of UMRA because it 

contains no regulatory requirements that 

might significantly or uniquely affect 

small governments. Small governments 

are not subject to the EPCRA section 313 

reporting requirements. EPA’s economic 

analysis indicates that the total cost of 

this action is estimated to be $531,002 

in the first year of reporting (Ref. 8). 

E. Executive Order 13132 (Federalism) 

This action does not have federalism 

implications. It will 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. 

F. Executive Order 13175: Consultation 

and Coordination With Indian Tribal 

Governments 

This action does not have tribal 

implications, as specified in Executive 

Order 13175. This action relates to toxic 

chemical reporting under EPCRA 

section 313, which primarily affects 

private sector facilities. Thus, Executive 

Order 13175 does not apply to this 

action. 

G. Executive Order 13045: Protection of 

Children From Environmental Health 

Risks and Safety Risks 

The EPA interprets Executive Order 

13045 as applying only to those 

regulatory actions that concern 

environmental health or safety risks that 

the EPA has reason to believe may 

disproportionately affect children, per 

the definition of ‘‘covered regulatory 

action’’ in section 2–202 of the 

Executive Order. This action is not 

subject to Executive Order 13045 

because it does not concern an 

environmental health risk or safety risk. 

H. Executive Order 13211: Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use 

This action is not subject to Executive 

Order 13211, because it is not a 

significant regulatory action under 

Executive Order 12866. 

I. National Technology Transfer and 

Advancement Act 

This rulemaking does not involve 

technical standards. 

J. Executive Order 12898: Federal 

Actions To Address Environmental 

Justice in Minority Populations and 

Low-Income Populations 

The EPA believes the human health or 

environmental risk addressed by this 

action will not have potential 

disproportionately high and adverse 

human health or environmental effects 

on minority, low-income or indigenous 

populations. The results of this 

evaluation are contained below. 

This action does not address any 

human health or environmental risks 

and does not affect the level of 

protection provided to human health or 

the environment. This action adds an 

additional chemical to the EPCRA 

section 313 reporting requirements. By 

adding a chemical to the list of toxic 

chemicals subject to reporting under 

section 313 of EPCRA, EPA would be 

providing communities across the 

United States (including minority 

populations and low income 

populations) with access to data which 

they may use to seek lower exposures 

and consequently reductions in 

chemical risks for themselves and their 

children. This information can also be 

used by government agencies and others 

to identify potential problems, set 

priorities, and take appropriate steps to 

reduce any potential risks to human 

health and the environment. Therefore, 

the informational benefits of the action 

will have a positive impact on the 

human health and environmental 

impacts of minority populations, lowincome populations, and children. 

List of Subjects in 40 CFR Part 372 

Environmental protection, 

Community right-to-know, Reporting 

and recordkeeping requirements, and 

Toxic chemicals. 

Dated: April 8, 2015. 

Gina McCarthy, 

Administrator. 

Therefore, 40 CFR part 372 is 

proposed to be amended as follows: 

PART 372—TOXIC CHEMICAL 

RELEASE REPORTING: COMMUNITY 

RIGHT-TO-KNOW 

■ 1. The authority citation for part 372 

continues to read as follows: 

Authority: 42 U.S.C. 11023 and 11048. 

■ 2. In § 372.65, paragraph (a) is 

amended by adding in the table the 

entry for ‘‘1-Bromopropane’’ in 

alphabetical order and in paragraph (b) 

by adding in the table the entry for 

‘‘106–94–5’’ in numerical order to read 

as follows: 

§ 372.65 Chemicals and chemical 

categories to which this part applies. 

* * * * * 

(a) * * * 

Chemical name CAS No. Effective 

date 

* * * * * 

1-Bromopropane ..... 106–94–5 1/1/16 

* * * * * 

(b) * * * 

CAS No. Chemical name Effective 

date 

* * * * * 

106–94–5 .. 1-Bromopropane 1/1/16 

* * * * * 

* * * * * 

[FR Doc. 2015–08664 Filed 4–14–15; 8:45 am] 

BILLING CODE 6560–50–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 73 

[MB Docket No. 15–88, RM–11747; DA 15– 

444] 

Television Broadcasting Services; 

Bend, Oregon 

AGENCY: Federal Communications 

Commission. 

ACTION: Proposed rule. 

SUMMARY: The Commission has before it 

a petition for rulemaking filed by TDS 

Broadcasting LLC (‘‘TDS’’), the licensee 

of KOHD, channel 51, Bend, Oregon, 

requesting the substitution of channel 

mstockstill on DSK4VPTVN1PROD with PROPOSALS