Federal Register / Vol. 75, No. 227 / Friday, November 26, 2010 / Rules and Regulations 72727 

EPA-APPROVED IDAHO REGULATIONS—Continued 

State citation Title/subject State effective date EPA approval date Explanations 

561 .................. General Rules ....................................... 4/11/06, 5/1/94, 3/15/02 ..... 11/26/2010 [Insert page 

number where the document begins] 

* * * * * * * 

575 .................. Air Quality Standards and Area Classification.4/11/06 ............................... 11/26/2010 [Insert page 

number where the document begins] 

* * * * * * * 

581 .................. Prevention of Significant Deterioration 

(PSD) Increments.

4/11/06, 5/3/03, 7/1/97, 5/1/ 

94.

11/26/2010 [Insert page 

number where the document begins] 

* * * * * * * 

679 .................. Averaging Period .................................. 4/11/06, 5/1/94 ................... 11/26/2010 [Insert page 

number where the document begins] 

* * * * * * * 

700 .................. Particulate Matter Process Weight Limitations.5/3/03, 4/5/00 ..................... 11/26/2010 [Insert page 

number where the document begins] 

* * * * * * * 

725 .................. Rules for Sulfur Content of Fuels ......... 5/8/09, 5/1/94 ..................... 11/26/2010 [Insert page 

number where the document begins] 

* * * * * 

[FR Doc. 2010–29628 Filed 11–24–10; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 372 

[EPA–HQ–TRI–2010–0006; FRL–9231–5] 

RIN 2025–AA28 

Addition of National Toxicology 

Program Carcinogens; Community 

Right-to-Know Toxic Chemical Release 

Reporting 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: EPA is adding 16 chemicals 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 of 1990 (PPA). These 16 chemicals 

have been classified by the National 

Toxicology Program in their Report on 

Carcinogens as ‘‘reasonably anticipated 

to be a human carcinogen.’’ EPA has 

determined that these 16 chemicals 

meet the EPCRA section 313(d)(2)(B) 

criteria because they can reasonably be 

anticipated to cause cancer in humans. 

DATES: This final rule is effective 

November 30, 2010, and shall apply for 

the reporting year beginning January 1, 

2011 (reports due July 1, 2012). 

ADDRESSES: EPA has established a 

docket for this action under Docket ID 

No. EPA–HQ–TRI–2010–0006. All 

documents in the docket are listed in 

the http://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 http:// 

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 or (703) 412– 

9810 in Virginia and Alaska or toll free, 

TDD (800) 553–7672, http:// 

www.epa.gov/epaoswer/hotline/. 

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 any of the chemicals 

included in this final rule. Potentially 

affected categories and entities may 

include, but are not limited to: 


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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) (correspond 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.) (correspond 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. 

II. Introduction 

A. What is the statutory authority for 

this final 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 more than 300 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) are met. The EPCRA section 

313(d)(2) criteria are: 

(A) 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. 

(B) The chemical is known to cause or 

can reasonably be anticipated to cause 

in humans— 

(i) cancer or teratogenic effects, or 

(ii) serious or irreversible— 

(I) reproductive dysfunctions, 

(II) neurological disorders, 

(III) heritable genetic mutations, or 

(IV) other chronic health effects. 

(C) The chemical is known to cause or 

can be reasonably anticipated to cause, 

because of 

(i) its toxicity, 

(ii) its toxicity and persistence in the 

environment, or 

(iii) 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 has 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. Summary of Proposed Rule 

A. What chemicals did EPA propose to 

add to the EPCRA section 313 list of 

toxic chemicals? 

As discussed in the proposed rule (75 

FR 17333, April 6, 2010) EPA proposed 

to add 16 chemicals to the EPCRA 

section 313 list of toxic chemicals. 

These 16 chemicals had been classified 

as ‘‘Reasonably Anticipated To Be 

Human Carcinogen’’ by the National 

Toxicology Program (NTP) in their 11th 

Report on Carcinogens (RoC) document. 

In addition, based on a review of the 

available production and use 

information, EPA determined that these 

16 chemicals are expected to be 

manufactured, processed, or otherwise 

used in quantities that would exceed the 

EPCRA section 313 reporting 

thresholds. The 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). As part of their cancer 

evaluation work, the NTP periodically 

publishes the RoC document which 

contains cancer classifications from the 

NTP’s most recent chemical evaluations 

as well as the classifications from 

previous versions of the RoC. There is 

an extensive review process for the RoC 

which includes evaluations by scientists 

from the NTP, other Federal health 

research and regulatory agencies 

(including EPA), and nongovernmental 

institutions. The RoC review process 

also includes external peer review and 

several opportunities for public 

comment. 


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B. What was EPA’s rationale for 

proposing to list the NTP carcinogens? 

As EPA stated in the proposed rule 

(75 FR 17334, April 6, 2010), the NTP 

RoC document undergoes significant 

scientific review and public comment 

and 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 therein to cause 

cancer in humans. Based on EPA’s 

review of the data contained in the 11th 

NTP RoC (Ref. 1) for the 16 chemicals, 

the Agency agreed that the chemicals 

can reasonably be anticipated to cause 

cancer. Therefore, EPA determined that 

the evidence was sufficient for listing all 

of the chemicals in the proposed rule on 

the EPCRA section 313 toxic chemical 

list pursuant to EPCRA section 

313(d)(2)(B) based on the available 

carcinogenicity data for the chemicals as 

presented in the 11th RoC (Ref. 2). 

IV. Summary of Final Rule 

EPA is finalizing the addition of the 

16 chemicals to the EPCRA section 313 

list of toxic chemicals. This final rule 

contains no changes to the list of 

chemicals EPA included in the 

proposed rule. EPA has determined that 

each of these 16 chemicals meets the 

listing criteria under EPCRA section 

313(d)(2)(B). The chemicals being added 

as individual chemical listings on the 

EPCRA section 313 list in this final rule 

include the following: 1-amino-2,4- 

dibromoanthraquinone; 2,2- 

bis(bromomethyl)-1,3-propanediol; 

furan; glycidol; isoprene; 

methyleugenol; o-nitroanisole; 

nitromethane; phenolphthalein; 

tetrafluoroethylene; tetranitromethane; 

and vinyl fluoride. In addition, the 

following chemicals are being added to 

the EPCRA section 313 chemical 

category for polycyclic aromatic 

compounds (PACs): 1,6-dinitropyrene; 

1,8-dinitropyrene; 6-nitrochrysene; and 

4-nitropyrene. The PACs category is a 

category of persistent, bioaccumulative, 

toxic (PBT) chemicals and as such has 

a lower reporting threshold of 100 

pounds (40 CFR 372.28(a)(2)). 

V. What comments did EPA receive on 

the Proposed Rule and what are EPA’s 

responses to those comments? 

EPA received nine comments on the 

proposed rule to add the 16 NTP 

carcinogens to the EPCRA section 313 

list. Seven of the comments were 

supportive of EPA’s proposed listings 

while two comments contained 

objections to the addition of these 

chemicals. The commenters that 

supported the proposed rule included; 

five individuals, OMB Watch, and PT 

AirWatchers. The two commenters that 

did not support the proposed rule were 

the Chemical Products Corporation and 

the International Institute of Synthetic 

Rubber Producers. The most significant 

comments are summarized and 

responded to below. The complete set of 

comments and EPA’s responses can be 

found in the response to comment 

document in the docket for this 

rulemaking (Ref. 3). 

The Chemical Products Corporation 

provided extensive comments on their 

review of the NTP technical report on 

anthraquinone, a chemical that was not 

included in those EPA proposed to list. 

The comments documented the issues 

and problems they believe exist with 

that technical report and their attempts 

to have the report revised. Their issues 

primarily concerned the identity of the 

materials tested. Based on their review 

and experience with NTP technical 

report for anthraquinone, the 

commenter believes that the NTP 

technical reports that were a primary 

basis for the NTP classification of the 

chemicals in the proposed rule as 

‘‘reasonably anticipated to be a human 

carcinogen’’ should not be relied upon 

by EPA for making decisions regarding 

the addition of chemicals to the EPCRA 

section 313 toxic chemical list. The 

commenter also suggested that EPA rely 

on the International Agency for 

Research on Cancer (IARC) Group 2A 

list (i.e., chemicals classified as 

probably carcinogenic to humans) and 

add only those chemicals which have 

IARC Group 2A classifications. That 

would include two chemicals, glycidol 

and vinyl fluoride out of the 16 at issue 

in this action. 

EPA notes that the commenter is 

questioning the validity of an NTP 

technical report that is unrelated to any 

of the chemicals that EPA proposed for 

listing. The report in question concerns 

anthraquinone, a chemical that was not 

the subject of the proposed rule, is not 

on the EPCRA section 313 list of toxic 

chemicals, and is not classified as a 

carcinogen in the NTP’s 11th Report on 

Carcinogens. The commenter believes 

that the scientific validity of all of the 

NTP technical reports is questionable 

because of problems they have with one 

of the NTP technical reports. As this 

report is outside the scope of the 

proposed rule, EPA is not addressing 

the specific issues the commenter has 

with the report or the NTP’s responses 

to the commenter. EPA does not believe 

that issues raised about one NTP 

technical report mean that the scientific 

validity of all NTP technical reports 

should be in question. As EPA 

discussed in the proposed rule, the NTP 

review process for the Report on 

Carcinogens is extensive and includes 

both peer review and public comment 

(75 FR 17335, April 6, 2010). In 

addition, as discussed in the proposed 

rule (75 FR 17336, April 6, 2010), EPA 

reviewed the NTP chemical profiles and 

supporting materials for each chemical 

proposed for listing. The commenter has 

provided no data that would suggest 

that the NTP reports for the 16 

chemicals being added to the EPCRA 

section 313 list are flawed or any data 

that would suggest the chemicals do not 

meet the EPCRA section 313(d)(2)(B) 

listing criteria. The Agency finds no 

specific basis to question any of the NTP 

documents used to support the listing of 

the 16 chemicals included in this rule 

based on these comments. 

Regarding the commenter’s suggestion 

that EPA only add those chemicals that 

have been classified as Group 2A 

(probably carcinogenic to humans) by 

IARC, EPA notes that the scientific data 

for a number of chemicals classified as 

Group 2B (possibly carcinogenic to 

humans) under IARC has been found to 

be sufficient to support listing under 

EPCRA section 313 (see for example, 59 

FR 1788, January 12, 1994). These 

determinations were the result of a caseby-case analysis of the available cancer 

data, they were not based solely on the 

IARC cancer classification. Thus, EPA 

would not limit the listing of 

carcinogens to only chemicals with 

IARC Group 2A classifications. Even for 

IARC 2A classified chemicals, EPA 

would review the available cancer data 

before making an EPCRA section 313 

listing determination. 

The International Institute of 

Synthetic Rubber Producers, Inc. (IISRP) 

stated that they found that overall there 

are no factual inaccuracies in EPA’s 

toxicology summaries, but that there 

were interpretations of the data they 

believed should be noted, plus certain 

environmental data which they thought 

should be included in the record. The 

IISRP noted that the proposed rule 

refers to similarities between isoprene 

and butadiene and stated that isoprene 

also differs from 1,3-butadiene in that 

for isoprene, there have been no 

elevations in thymic lymphoma in 

exposed mice at any concentrations 

tested. The commenter stated that the 

absence of this response in mice with 

isoprene is noteworthy since the basis of 

butadiene’s IARC Group1 classification 


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is all hemolytic organs (which the 

commenter stated would include 

lymphomas). The commenter stated that 

the various other tumor types occurring 

with isoprene or butadiene in mice are 

not seen in epidemiology studies of 

butadiene-exposed populations. The 

commenter also stated that there were 

no elevations in tumors found in mice 

at the lowest exposure tested (10 ppm; 

28 mg/m3) and this coupled with the 

fact that isoprene is produced 

endogenously in humans suggests that 

there is a threshold for such a response. 

The commenter stated that this 

information supports the IARC 2B 

categorization of isoprene as a 

‘‘possible’’ human carcinogen rather 

than the ‘‘reasonably anticipated’’ 

categorization by NTP, which triggers 

the TRI listing. 

The IISRP also stated that EPA 

omitted certain environmental data that 

should be included in the record. The 

commenter stated that IARC notes that 

isoprene occurs in the environment as 

emissions from vegetation, particularly 

from deciduous forests. The commenter 

cited sources that state that isoprene is 

the dominant hydrocarbon released by 

vegetation in most ecosystems. The 

commenter also cited sources that state 

that isoprene release by vegetation, 

particularly trees, exceeds 

anthropogenic hydrocarbon release to 

the atmosphere. The commenter stated 

that isoprene has also been found in 

tobacco smoke, gasoline, turbine and 

automobile exhaust and in emissions 

from wood pulping, biomass 

combustion and rubber abrasion. 

EPA disagrees with the IISRP that 

EPA should use the IARC ‘‘possible’’ 

human carcinogen classification for 

isoprene rather than the ‘‘reasonably 

anticipated’’ categorization by NTP. 

Since isoprene is an analog of 1,3- 

butadiene, the NTP provided data on 

1,3-butadiene under the section on 

‘‘Additional Information Relevant to 

Carcinogenicity’’ (Ref. 4). The 

commenter pointed out differences 

between isoprene and butadiene, 

however, the NTP also recognizes that 

there are differences in the data for 

isoprene and 1,3-butadiene as 

evidenced by the NTP’s classification of 

1,3-butadiene as a ‘‘known to be a 

human carcinogen’’ (Ref. 2). For 

isoprene, the NTP found evidence of 

tumor formation at multiple organ sites 

in multiple species of experimental 

animals (Ref. 4). Nothing in the 

commenter’s statements leads EPA to 

believe that isoprene is not correctly 

classified by NTP as ‘‘reasonably 

anticipated to be a human carcinogen’’ 

or that the data underlying that 

classification suggests the isoprene does 

not meet the EPCRA section 313(d)(2)(B) 

listing criteria. 

EPA also disagrees with IISRP’s 

characterization that the NTP 

classification is a trigger for TRI listing. 

According to EPCRA § 313(d)(2), a 

chemical may be added to the TRI list 

if it ‘‘is known to cause or can 

reasonably be anticipated to cause in 

humans cancer.’’ Particular listings by 

scientific bodies, such as the NTP, are 

useful in determining whether that 

standard has been met but are not 

necessarily triggers for listing under 

EPCRA. EPA does not take an IARC 

Group 2B classification to automatically 

mean that a chemical would not meet 

the EPCRA section 313 listing criteria. 

EPA again notes that in previous EPCRA 

section 313 listing decisions, the 

scientific data for a number of chemicals 

classified as Group 2B (possibly 

carcinogenic to humans) under the 

IARC has been found to be sufficient to 

support listing under EPCRA section 

313 (see for example potassium 

bromate, sodium o-phenylphenoxide, 

and other chemicals in 59 FR 1788, 

January 12, 1994). These determinations 

were the result of a case-by-case 

analysis of the available cancer data; 

they were not based solely on the IARC 

cancer classification. Thus, EPA would 

not limit the listing of carcinogens to 

only chemicals with IARC Group 2A 

classifications. Even for IARC 2A 

classified chemicals, EPA would review 

the available cancer data before making 

a listing determination. 

The environmental data that the 

commenter suggests is missing from the 

rulemaking record actually is discussed 

in detail in the supporting documents 

cited in the proposed rule. For example, 

reference number 13 in the proposed 

rule (Ref. 4 in today’s final rule) 

contains the following discussion: 

Exposure 

Isoprene is formed endogenously in 

humans and is generally the major 

hydrocarbon (up to 70% in human breath) 

(Gelmont et al. 1981). Concentrations in 

blood range from 15 to 70 nmol/L (1.0 to 4.8 

μg/L) (Cailleux et al. 1992). Humans produce 

isoprene endogenously at a rate of 0.15 μmol/ 

kg/h, equivalent to approximately 17 mg/day 

for a 150-lb (70-kg) person (Taalman 1996). 

Endogenous production rates reported for 

rats and mice are 1.9 and 0.4 μmol/kg/h, 

respectively (Peter et al. 1987). Ambient air 

concentrations of isoprene are generally less 

than 10 ppb or approximately 0.03 mg 

isoprene/m3. Based on estimated human 

intake of 15 to 20 m3 air per day, ambient air 

would contribute less than 0.45 to 0.6 mg/ 

day to daily isoprene exposure. 

NIOSH collected data on potential 

exposure to isoprene in the National 

Occupational Hazard Survey (NOHS) 

from 1972 to 1974 (NIOSH 1976) and in 

the National Occupational Exposure 

Survey (NOES) from 1981 to 1983 

(NIOSH 1990). The first survey (NIOSH 

1976) indicated that 58,000 employees 

in over 30 different industries were 

potentially exposed to isoprene. The 

more limited later survey of six 

industries showed that approximately 

3,700 workers were potentially exposed 

to isoprene between 1981 and 1983 

(NIOSH 1990). Isoprene is emitted from 

plants and trees and is widely present 

in the environment at low 

concentrations (Taalman 1996). 

Isoprene global emissions, estimated at 

175 to 503 million Mg per year, 

represent approximately 44 to 51% of 

total global natural volatile organic 

compound emissions (Guenther et al. 

1995). The average biogenic emission 

rate factor for isoprene in the United 

States is approximately 3 mg/m2/h. 

Isoprene concentrations in biogenic 

emissions range from 8% to 91% of total 

VOCs, with a 58% average. Since 

isoprene biosynthesis is associated with 

photosynthesis, isoprene emissions are 

negligible at night (Guenther et al. 

1994). The south central and 

southeastern areas of the United States 

have the highest biogenic emissions. 

Summertime isoprene emissions are 

highest in each region and account for 

more than 50% of annual biogenic 

emissions (Lamb et al. 1993). 

Sources of anthropogenic releases of 

isoprene to the atmosphere include 

ethylene production by cracking 

naphtha, wood pulping, oil fires, woodburning stoves and fireplaces, other 

biomass combustion, tobacco smoking 

(3,100 μg/cigarette), gasoline, and 

exhaust of turbines and automobiles 

(HSDB 2000). 

Reported U.S. ambient air 

concentrations of isoprene range from 

0.003 to 0.06 mg/m3 (1 to 21 ppb), with 

isoprene representing less than 10% of 

NMHCs (Arnts and Meeks 1980, 

Altschuller 1983, Lawrimore and Aneja 

1997, Hagerman et al. 1997). During 

stagnation conditions, biogenic 

hydrocarbons may contribute more to 

total atmospheric hydrocarbons 

(Altschuller 1983). 

Foods of plant origin would be 

expected to be a source of daily 

exposure to isoprene since it is emitted 

by agricultural crops and is the basic 

structural unit in countless natural 

products found in foods such as 

terpenes and vitamins A and K (IARC 

1994). Its occurrence has been reported 

in the essential oil of oranges, in the 

fruit of hops, and in the root of carrots 

(Duke 1992). 

The primary source of isoprene in 

indoor air is environmental tobacco 


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smoke. Isoprene was found to be the 

major component of hydrocarbons in 

the air of a smoky cafe ́ (10 smoking 

patrons, 10 not smoking) (16.7%) and 

sidestream smoke (29.2%) (Barrefors 

and Petersson 1993). A monitoring 

survey in November 1992 in homes and 

workplaces in the greater Philadelphia 

area found mean isoprene 

concentrations in personal air samples 

of 4.65 μg/m3 in nonsmoking homes (n 

= 60), 18.15 μg/m3 in smoking homes (n 

= 29), 5.29 μg/m3 in nonsmoking 

workplaces (n = 51), and 22.80 μg/m3 in 

smoking workplaces (n = 28). 

Differences in isoprene concentrations 

in personal air between nonsmoking 

and smoking sites were highly 

significant (Heavner et al. 1996). 

Another survey reported median 

summertime isoprene concentrations of 

2.90 μg/m3 in indoor air (n = 3; no 

information on whether occupants were 

smokers or nonsmokers) compared to 

0.40 μg/m3 in outdoor air (n = 1) in the 

Lower Rio Grande Valley of Texas 

(Muerjee et al. 1997). 

As the text above clearly shows, 

information on environmental data was 

not omitted from the rulemaking record. 

However, as this information was not 

directly related to the hazard 

determination for isoprene being used 

as a basis to list the chemical under 

EPCRA section 313, it was not included 

in the text of the Federal Register notice 

for the proposed rule. 

VI. References 

EPA has established an official public 

docket for this action under Docket ID 

No. EPA–HQ–TRI–2010–0006. 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. 

1. USEPA, OEI. Memorandum from 

Mark Miller, Ph.D., Toxicologist, 

Analytical Support Branch to Nicole 

Paquette, Ph.D., Chief, Analytical 

Support Branch. January 28, 2010. 

Subject: Review of National Toxicology 

Program (NTP) Cancer Classification 

Data for Sixteen Chemicals. 

2. NTP, 2005. National Toxicology 

Program. Introduction: Report on 

Carcinogens, Eleventh Edition. Released 

January 31, 2005. U.S. Department of 

Health and Human Services, Public 

Health Service, National Toxicology 

Program, Research Triangle Park, NC 

27709. 

3. USEPA, OEI. Response to 

Comments Received on the April 6, 

2010, Federal Register Proposed Rule 

(75 FR 17333): Addition of National 

Toxicology Program Carcinogens; 

Community Right-to-Know Toxic 

Chemical Release Reporting. U.S. 

Environmental Protection Agency, 

Office of Environmental Information, 

Office of Information Analysis and 

Access. August 12, 2010. 

4. NTP, 2005. National Toxicology 

Program. 11th Report on Carcinogens— 

Isoprene Substance Profile. Released 

January 31, 2005. U.S. Department of 

Health and Human Services, Public 

Health Service, National Toxicology 

Program, Research Triangle Park, NC 

27709. 

VII. Statutory and Executive Order 

reviews associated with this action? 

A. Executive Order 12866, Regulatory 

Planning and Review 

Under Executive Order (EO) 12866 

(58 FR 51735, October 4, 1993), this 

action is a ‘‘significant regulatory 

action.’’ The Office of Management and 

Budget (OMB) determined that this 

action raises novel legal or policy issues 

arising out of legal mandates, the 

President’s priorities, or the principles 

set forth in the Executive Order. 

Accordingly, EPA submitted this action 

to OMB for review under EO 12866 and 

any changes made in response to OMB 

recommendations have been 

documented in the docket for this 

action. 

B. Paperwork Reduction Act 

This final rule does not contain any 

new information collection 

requirements that require additional 

approval by the OMB under the 

Paperwork Reduction Act (PRA), 44 

U.S.C. 3501 et. seq. 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 

Form R, supplier notification, and 

petitions under OMB Control number 

2025–0009 (EPA Information Collection 

Request (ICR) No. 1363.15); those 

related to Form A under OMB control 

number 2025–0010 (EPA ICR No. 

1704.09); and those related to trade 

secret designations under OMB Control 

2070–0078 (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). 

For Form R, EPA estimates the 

industry reporting and recordkeeping 

burden for collecting this information to 

average, in the first year, approximately 

$4,615 per Form R (for a total first year 

cost of $858,299 based on 16,069 total 

burden hours). In subsequent years, the 

burden for collecting this information is 

estimated to average $1,553 per Form R 

(for a total cost of $288,902 based on 

5,517 total burden hours). These 

estimates include the time needed to 

become familiar with the requirement 

(first year only); review instructions; 

search existing data sources; gather and 

maintain the data needed; complete and 

review the collection information; and 

transmit or otherwise disclose the 

information. The actual burden on any 

facility may be different from this 

estimate depending on the complexity 

of the facility’s operations and the 

profile of the releases at the facility. 

Upon promulgation of a final rule, the 

Agency may determine that the existing 

burden estimates in the ICRs need to be 

amended in order to account for an 

increase in burden associated with the 


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72732 Federal Register / Vol. 75, No. 227 / Friday, November 26, 2010 / Rules and Regulations 

final action. If so, the Agency will 

submit an information collection 

worksheet (ICW) to OMB requesting that 

the total burden in each ICR be 

amended, as appropriate. 

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. 

The RFA generally requires an agency 

to prepare a regulatory flexibility 

analysis of any rule subject to notice 

and comment rulemaking requirements 

under the Administrative Procedure Act 

or any other statute unless the agency 

certifies that the rule will not have a 

significant economic impact on a 

substantial number of small entities. 

Small entities include small businesses, 

small organizations, and small 

governmental jurisdictions. For 

purposes of assessing the impacts of 

today’s rule on small entities, small 

entity is defined as: (1) A business that 

is classified as a ‘‘small business’’ by the 

Small Business Administration at 13 

CFR 121.201; (2) a small governmental 

jurisdiction that is a government of a 

city, county, town, school district or 

special district with a population of less 

than 50,000; and (3) a small 

organization that is any not-for-profit 

enterprise which is independently 

owned and operated and is not 

dominant in its field. 

Of the 109 entities estimated to be 

impacted by this rule, 41 are small 

businesses. Of the affected small 

businesses, all 41 have cost impacts of 

less than 1% in both the first and 

subsequent years of the rulemaking. No 

small businesses are projected to have a 

cost impact of 1% or greater. In the first 

year, of the 41 estimated cost impacts, 

there is a maximum impact of 0.616% 

and a minimum impact of less than 

0.001%. 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. No small governments or 

small organizations are expected to be 

affected by this action. Thus this rule 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. 

After considering the economic 

impacts of today’s rule on small entities, 

I certify that this action will not have a 

significant economic impact on a 

substantial number of small entities. 

D. Unfunded Mandates Reform Act 

This rule does not contain a Federal 

mandate that may result in expenditures 

of $100 million or more for State, local, 

and tribal governments, in the aggregate, 

or the private sector in any one year. 

EPA’s economic analysis indicates that 

the total cost of this rule is estimated to 

be $859,072 in the first year of 

reporting. Thus, this rule is not subject 

to the requirements of sections 202 or 

205 of UMRA 

This rule is also not subject to the 

requirements of section 203 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. 

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, as specified in 

Executive Order 13132. This action 

relates to toxic chemical reporting under 

EPCRA section 313, which primarily 

affects private sector facilities. Thus, 

Executive Order 13132 does not apply 

to this action. 

F. Executive Order 13175: Consultation 

and Coordination With Indian Tribal 

Governments 

This action does not have tribal 

implications, as specified in Executive 

Order 13175 (65 FR 67249, November 9, 

2000). 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 

This action is not subject to EO 13045 

(62 FR 19885, April 23, 1997) because 

it is not economically significant as 

defined in EO 12866, and because the 

Agency does not believe the 

environmental health or safety risks 

addressed by this action present a 

disproportionate risk to children. This 

action relates to toxic chemical 

reporting under EPCRA section 313, 

which primarily affects private sector 

facilities. 

H. Executive Order 13211: Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use 

This action is not a ‘‘significant energy 

action’’ as defined in Executive Order 

13211 (66 FR 28355 (May 22, 2001)), 

because it is not likely to have a 

significant adverse effect on the supply, 

distribution, or use of energy. Further, 

we have concluded that this action is 

not likely to have any adverse energy 

effects because it does not impact the 

production of energy. 

I. National Technology Transfer and 

Advancement Act 

Section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (‘‘NTTAA’’), Public Law 

104–113, 12(d) (15 U.S.C. 272 note) 

directs EPA to use voluntary consensus 

standards in its regulatory activities 

unless to do so would be inconsistent 

with applicable law or otherwise 

impractical. Voluntary consensus 

standards are technical standards (e.g., 

materials specifications, test methods, 

sampling procedures, and business 

practices) that are developed or adopted 

by voluntary consensus standards 

bodies. NTTAA directs EPA to provide 

Congress, through OMB, explanations 

when the Agency decides not to use 

available and applicable voluntary 

consensus standards. 

This rulemaking does not involve 

technical standards. Therefore, EPA did 

not consider the use of any voluntary 

consensus standards. 

J. Executive Order 12898: Federal 

Actions To Address Environmental 

Justice in Minority Populations and 

Low-Income Populations 

Executive Order (EO) 12898 (59 FR 

7629 (Feb. 16, 1994)) establishes Federal 

executive policy on environmental 

justice. Its main provision directs 

Federal agencies, to the greatest extent 

practicable and permitted by law, to 

make environmental justice part of their 

mission by identifying and addressing, 

as appropriate, disproportionately high 

and adverse human health or 

environmental effects of their programs, 

policies, and activities on minority 

populations and low-income 

populations in the United States. 

EPA has determined that this final 

rule will not have disproportionately 

high and adverse human health or 

environmental effects on minority or 

low-income populations because it does 

not affect the level of protection 

provided to human health or the 

environment. This rule adds additional 

chemicals to the EPCRA section 313 


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Federal Register / Vol. 75, No. 227 / Friday, November 26, 2010 / Rules and Regulations 72733 

reporting requirements. By adding 

chemicals 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 rule 

will have a positive impact on the 

human health and environmental 

impacts of minority populations, lowincome populations, and children. 

K. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. 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. A Major rule 

cannot take effect until 60 days after it 

is published in the Federal Register. 

This action is not a ‘‘major rule’’ as 

defined by 5 U.S.C. 804(2). This rule 

will be effective November 30, 2010. 

List of Subjects in 40 CFR Part 372 

Environmental protection, 

Community right-to-know, Reporting 

and recordkeeping requirements, and 

Toxic chemicals. 

Dated: November 18, 2010. 

Lisa P. Jackson, 

Administrator. 

■ Therefore, 40 CFR part 372 is 

amended as follows: 

PART 372—[AMENDED] 

■ 1. The authority citation for part 372 

continues to read as follows: 

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

■ 2. In § 372.28 the table in paragraph 

(a)(2) is amended under the heading 

‘‘Polycyclic aromatic compounds 

(PACs): (This category includes only 

those chemicals listed below)’’ by 

adding four new entries in alphabetical 

order to read as follows: 

§ 372.28 Lower thresholds for chemicals 

of special concern. 

(a) * * * 

(2) * * * 

Category name Reporting 

threshold 

*****

Polycyclic aromatic compounds 

(PACs): (This category includes only those chemicals 

listed below). ......................... 100 

*****

42397–64–8 1,6- 

Dinitropyrene.

42397–65–9 1,8- 

Dinitropyrene.

*****

07496–02–8 6- 

Nitrochrysene.

*****

57835–92–4 4- 

Nitropyrene.

*****

■ 3. Section 372.65 is amended as 

follows: 

■ a. In the table to paragraph (a) by 

adding new entries in alphabetical 

order. 

■ b. In the table to paragraph (b) by 

adding new entries in numerical order. 

■ c. In the table to paragraph (c) under 

the heading ‘‘Polycyclic aromatic 

compounds (PACs): (This category 

includes only those chemicals listed 

below)’’ by adding four entries in 

alphabetical order. 

§ 372.65 Chemicals and chemical 

categories to which the part applies. 

* * * * * 

(a) * * * 

Chemical name CAS No. Effective 

date 

*****

1-Amino-2,4- 

dibromoanthraquinone ............................. 00081–49–2 1/11 

*****

2,2-bis(Bromomethyl)- 

1,3-propanediol ........ 003296–90–0 1/11 

Furan ........................... 00110–00–9 1/11 

*****

Glycidol ........................ 00556–52–5 1/11 

*****

Isoprene ....................... 00078–79–5 1/11 

*****

Methyleugenol ............. 00093–15–2 1/11 

*****

o-Nitroanisole ............... 00091–23–6 1/11 

*****

Nitromethane ............... 00075–52–5 1/11 

* ***

Phenolphthalein ........... 00077–09–8 1/11 

*****

Tetrafluoroethylene ...... 00116–14–3 1/11 

*****

Tetranitromethane ....... 00509–14–8 1/11 

*****

Vinyl Fluoride ............... 00075–02–5 1/11 

*****

(b) * * * 


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72734 Federal Register / Vol. 75, No. 227 / Friday, November 26, 2010 / Rules and Regulations 

CAS No. Chemical name Effective 

date 

*******

00075–02–5 ................................................................................. Vinyl Fluoride ............................................................................. 1/11 

* * * * * * * 

00075–52–5 ................................................................................. Nitromethane .............................................................................. 1/11 

*******

00077–09–8 ................................................................................. Phenolphthalein ......................................................................... 1/11 

*******

00078–79–5 ................................................................................. Isoprene ..................................................................................... 1/11 

*******

00081–49–2 ................................................................................. 1-Amino-2,4-dibromoanthraquinone .......................................... 1/11 

*******

00091–23–6 ................................................................................. o-Nitroanisole ............................................................................. 1/11 

*******

00093–15–2 ................................................................................. Methyleugenol ............................................................................ 1/11 

*******

00110–00–9 ................................................................................. Furan .......................................................................................... 1/11 

*******

00116–14–3 ................................................................................. Tetrafluoroethylene .................................................................... 1/11 

*******

00509–14–8 ................................................................................. Tetranitromethane ...................................................................... 1/11 

*******

00556–52–5 ................................................................................. Glycidol ...................................................................................... 1/11 

*******

03296–90–0 ................................................................................. 2,2-bis(Bromomethyl)-1,3-propanediol ....................................... 1/11 

*******

(c) * * * 

Category name Effective 

date 

*****

Polycyclic aromatic compounds (PACs): (This category includes only those 

chemicals listed below) 

*****

42397–64–8 1,6- 

Dinitropyrene .................. 1/11 

42397–65–9 1,8- 

Dinitropyrene .................. 1/11 

*****

07496–02–8 6- 

Nitrochrysene ................. 1/11 

*****

57835–92–4 4– 

Nitropyrene .................... 1/11 

*****

[FR Doc. 2010–29627 Filed 11–24–10; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 648 

[Docket No. 0907301205–0289–02] 

RIN 0648–XA053 

Fisheries of the Northeastern United 

States; Atlantic Herring Fishery; 

Temporary Removal of 2,000-lb (907.2- 

kg) Herring Trip Limit in Atlantic 

Herring Management Area 1A 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Temporary rule. 

SUMMARY: NMFS announces a temporary 

removal of the 2,000-lb (907.2 kg) trip 

limit for the Atlantic herring fishery in 

Management Area 1A (Area 1A) because 

catch data indicate that 95 percent of 

the total allowable catch (TAC) 

threshold in Area 1A has not been fully 

attained. Vessels issued a Federal 

permit to harvest Atlantic herring may 

resume fishing for and landing herring 

in amounts greater than 2,000 lb (907.2 

kg), consistent with their respective 

Atlantic herring permit categories, 

effective 0001 hrs, November 29, 2010, 

through 0001 hrs, December 3, 2010. At 

0001 hrs, December 3, 2010, vessels will 

again be prohibited from fishing for, 

catching, possessing, transferring, or 

landing more than 2,000 lb (907.2 kg) of 

Atlantic herring per trip or calendar 

day. 

DATES: Effective 0001 hours, November 

29, 2010, through 0001 hours, December 

3, 2010. 

FOR FURTHER INFORMATION CONTACT: 

Lindsey Feldman, Fishery Management 

Specialist, 978–675–2179. 

SUPPLEMENTARY INFORMATION: 

Regulations governing the Atlantic 

herring fishery are found at 50 CFR part 

648. The regulations require annual 

specification of optimum yield, 

domestic and foreign fishing, domestic 

and joint venture processing, and 

management area TACs. Final herring 

specifications for 2010–2012 published 

on August 12, 2010 (75 FR 48874). The 

2010 total TAC is 91,200 mt, allocated 

to the herring management areas as 

follows: 26,546 mt to Area 1A; 4,362 mt 


srobinson on DSKHWCL6B1PROD with RULES