Addition of 1-Bromopropane; Community Right-to-Know Toxic Chemical Release Reporting, 72906-72914 [2015-29799]

Download as PDF 72906 Federal Register / Vol. 80, No. 225 / Monday, November 23, 2015 / Rules and Regulations EPA-APPROVED VIRGINIA REGULATIONS AND STATUTES—Continued State effective date State citation Title/subject 5–85–50 ............................ Definitions .................................................................... 03/13/14 5–85–55 ............................ Actual plantwide applicability limits (PALs) ................. 03/13/14 * * * * * * * * [FR Doc. 2015–29680 Filed 11–20–15; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 372 [EPA–HQ–TRI–2015–0011; FRL–9937–12– OEI] RIN 2025–AA41 Addition of 1-Bromopropane; Community Right-to-Know Toxic Chemical Release Reporting Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: The Environmental Protection Agency (EPA) is adding 1bromopropane 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 SUMMARY: * 11/23/15 [Insert Federal Register citation]. 11/23/15 [Insert Federal Register citation]. Added. * * * the National Toxicology Program in their 13th Report on Carcinogens as ‘‘reasonably anticipated to be a human carcinogen.’’ The EPA has determined that 1-bromopropane meets the EPCRA section 313(d)(2)(B) criteria because it can reasonably be anticipated to cause cancer in humans. DATES: This final rule is effective November 30, 2015, and shall apply for the reporting year beginning January 1, 2016 (reports due July 1, 2017). ADDRESSES: The EPA has established a docket for this action under Docket ID No. EPA–HQ–TRI–2015–0011. All documents in the docket are listed on the https://www.regulations.gov Web site. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available electronically through https:// www.regulations.gov. Explanation [former SIP citation] EPA approval date 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, https://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: Examples of potentially affected entities Industry ........................................... wgreen on DSK2VPTVN1PROD with RULES Category 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, 221118, 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 facilities. Federal Government ....................... 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 VerDate Sep<11>2014 13:22 Nov 20, 2015 Jkt 238001 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. PO 00000 Frm 00008 Fmt 4700 Sfmt 4700 To determine whether your facility would be affected by this action, you should carefully examine the applicability criteria in part 372 subpart E:\FR\FM\23NOR1.SGM 23NOR1 Federal Register / Vol. 80, No. 225 / Monday, November 23, 2015 / Rules and Regulations 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. wgreen on DSK2VPTVN1PROD with RULES 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 the EPA to add or delete chemicals from the list and sets criteria for these actions. EPCRA section 313(d)(2) states that the 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, the 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 the EPA must demonstrate that none of the listing criteria in Section 313(d)(2)(A)-(C) are met. The EPCRA section 313(d)(2)(A)– (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. VerDate Sep<11>2014 13:22 Nov 20, 2015 Jkt 238001 • 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. The 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.’’ The 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. Summary of Proposed Rule A. What chemical did the EPA propose to add to the EPCRA section 313 list of toxic chemicals? As discussed in the proposed rule (80 FR 20189, April 15, 2015), the EPA proposed to add 1-bromopropane to the EPCRA section 313 list of toxic chemicals. 1-Bromopropane had been classified as ‘‘reasonably anticipated to be a human carcinogen’’ by the National Toxicology Program (NTP) in its 13th Report on Carcinogens (RoC) document. In addition, based on a review of the available production and use information, the EPA determined that 1bromopropane is 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 the NTP’s cancer evaluation work, it 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 the EPA), and nongovernmental institutions. The RoC review process also includes external PO 00000 Frm 00009 Fmt 4700 Sfmt 4700 72907 peer review and several opportunities for public comment. B. What was the EPA’s rationale for proposing to list 1-bromopropane? As the EPA stated in the proposed rule (80 FR 20189, April 15, 2015), the NTP RoC document undergoes significant scientific review and public comment and mirrors the review the 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. The 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 the EPA’s review of the data contained in the 13th NTP RoC (Reference (Ref.) 1) for 1-bromopropane, the Agency agreed that 1-bromopropane can reasonably be anticipated to cause cancer. Therefore, the EPA determined that the evidence was sufficient for listing 1bromopropane on the EPCRA section 313 toxic chemical list pursuant to EPCRA section 313(d)(2)(B) based on the available carcinogenicity data for 1bromopropane as presented in the 13th RoC (Ref. 2). IV. What comments did the EPA receive on the proposed rule? The EPA received four comments on the proposed rule to add 1bromopropane to the EPCRA section 313 chemical list. Three of the comments were supportive of the EPA’s proposed addition of 1-bromopropane while one commenter objected to the addition. The commenters that supported the proposed rule included two anonymous comments from the general public (Refs. 3 and 4) and a comment from the Halogenated Solvents Industry Alliance, Inc. (HSIA) (Ref. 5). Members of the HSIA include The Dow Chemical Company, INEOS Chlor Americas, Inc., Occidental Chemical, and Axiall Corporation. The commenter who objected to the addition was the Albemarle Corporation (Ref. 6). The most significant comments are summarized and responded to below. The complete set of comments and the EPA’s responses can be found in the response to comment document in the docket for this rulemaking (Ref. 7). Note that in some of the comments 1bromopropane is referred to as nPB, which is the acronym for the alternative chemical name n-propyl bromide. The HSIA (Ref. 5) stated that the proposed rule presented substantial E:\FR\FM\23NOR1.SGM 23NOR1 wgreen on DSK2VPTVN1PROD with RULES 72908 Federal Register / Vol. 80, No. 225 / Monday, November 23, 2015 / Rules and Regulations evidence to support the conclusion that 1-bromopropane is known to cause or can reasonably be anticipated to cause cancer in humans. The HSIA also noted that other published studies indicate that 1-bromopropane is neurotoxic, may cause reproductive dysfunction, and is acutely or chronically toxic. The HSIA concluded that clearly, the scientific literature supports the addition of 1bromopropane to the list of chemicals subject to reporting under EPCRA section 313. EPA agrees with the commenter’s statement that the EPA provided substantial evidence to support the conclusion that 1-bromopropane is known to cause or can reasonably be anticipated to cause cancer in humans. The EPA also agrees with the commenter’s conclusion that the scientific literature supports the addition of 1-bromopropane to the EPCRA section 313 chemical list. The EPA acknowledges that there may be other toxicological effects that may also be a basis for listing. However, the EPA believes the available cancer data are sufficient for adding 1-bromopropane to the EPCRA section 313 chemical list. The first anonymous commenter (Ref. 3) supported the addition of 1bromopropane to the EPCRA section 313 list and cited additional toxicity information, neurotoxicity and reproductive toxicity, as being of concern. EPA agrees that 1-bromopropane should be added to the EPCRA section 313 chemical list. The EPA also acknowledges that there may be other toxicological effects (such as neurotoxicity) that may also be a basis for listing. However, the available cancer data are sufficient for adding 1bromopropane to the EPCRA section 313 chemical list. The second anonymous commenter (Ref. 4) supported the listing of 1bromopropane as long as the benefits substantially outweigh the costs. The commenter also expressed concern that there may be ‘‘significant costs to local businesses, i.e., laundry services, that have to update or replace their equipment as well as significant costs and time spent in order to comply with the rule.’’ EPA’s cost-benefit analysis was contained in the economic analysis for the proposed rule ‘‘Economic Analysis of the Proposed Rule to add 1Bromopropane to the EPCRA Section 313 List of Toxic Chemicals’’ (Ref. 8), which was reference 8 in the proposed rule (80 FR 20189, April 15, 2015). The economic analysis contains a quantitative estimate of the costs and a qualitative discussion of the benefits of VerDate Sep<11>2014 13:22 Nov 20, 2015 Jkt 238001 the rule. The EPA considers the benefits of reporting under this rule to be primarily reflected by the purposes served by reporting of information under EPCRA section 313. The EPA believes the benefits provided by the information to be reported under this rule outweigh the costs. With regard to laundry services (such as dry cleaners) these facilities are not subject to reporting under EPCRA section 313. Even if such facilities were subject to reporting, listing a chemical under EPCRA section 313 does not require covered facilities to update or replace any equipment. EPCRA section 313 only requires the reporting of release and waste management information, it does not impose any restrictions on the use of chemicals. The majority of comments provided by the Albemarle Corporation (Ref. 6) are the same comments they submitted in response to the ‘‘Receipt of a complete petition’’ to add 1bromopropane to the Hazardous Air Pollutant (HAP) List (80 FR 6676, February 6, 2015). The only comments submitted by the Albemarle Corporation specific to the EPA’s proposed rule to add 1-bromopropane to the EPCRA section 313 chemical list were provided in a letter from Charles R. Nestrud of the law firm Chisenhall, Nestrud & Julian, P.A. dated June 10, 2015 (Nestrud letter). The EPA is providing responses to all of the comments in the Nestrud letter. The vast majority of the comments submitted by the Albemarle Corporation on the HAP listing petition dealt with issues of emissions, exposure, risk values, and risk assessment, which are not relevant to the proposed addition of 1-bromopropane to the EPCRA section 313 chemical list since the addition is based on hazard and not risk. The addition of 1-bromopropane to the EPCRA section 313 chemical list is based on the cancer hazard evaluation carried out by the NTP and reviewed by the EPA to ensure its consistency with the EPA Guidelines for Carcinogen Risk Assessment (Ref. 9). Consistent with the EPA guidelines (Ref. 9), the NTP 13th RoC (Ref. 2) evaluates the scientific literature and publicly available, peerreviewed technical reports of human and laboratory studies to evaluate whether substances are possible human carcinogens. The NTP RoC does not present a quantitative assessment of the risks of cancer associated with a given chemical. Rather, it indicates the potential hazard associated with chemicals but does not establish the exposure conditions that would pose cancer risks to individuals. In the 13th RoC, the NTP classified 1- PO 00000 Frm 00010 Fmt 4700 Sfmt 4700 bromopropane as ‘‘reasonably anticipated to be a human carcinogen.’’ The conclusions of the NTP 13th RoC for 1-bromopropane were consistent with how the EPA would consider the carcinogenicity data available for 1bromopropane. Therefore, for the purposes of listing 1-bromopropane on the EPCRA section 313 chemical list, the EPA concluded that 1bromopropane can reasonably be anticipated to cause cancer in humans. Since the listing of 1-bromopropane under EPCRA section 313 is based on the available cancer data, the EPA is not responding to the comments from Albemarle Corporation on the HAP listing petition that dealt with issues of emissions, exposure, risk values, and risk assessment. While not specific to the materials the EPA cited to support the addition of 1bromopropane to the EPCRA section 313 chemical list, there were some comments on the cancer data for 1bromopropane in the materials that the Albemarle Corporation submitted in response to the HAP listing petition (Ref. 6). Specifically, these comments are contained in sections 2.2 and 2.3 of the document ‘‘Comments on the Petition to Add n-Propyl Bromide to the List of Hazardous Air Pollutants Regulated under § 112 of the Clean Air Act’’ prepared by the Gradient Corporation (Gradient Corp.). Since these comments dealt with the toxic endpoint (cancer) that is the basis for the addition of 1-bromopropane to the EPCRA section 313 chemical list, the EPA has addressed these comments as well. In the Nestrud letter, the commenter stated that: The comments prepared by Albemarle and its consultants demonstrate that the technical information submitted to support the Proposed Rule is out of date, incorrect, and insufficient to support the Proposed Rule. Furthermore, when all toxicological data is considered, and current emission data is considered, the weight of the evidence does not support adding 1-bromopropane to the list of toxic chemicals. EPA disagrees that the information submitted to support the proposed rule to add 1-bromopropane to the EPCRA section 313 chemical list is ‘‘out of date, incorrect, and insufficient to support the Proposed Rule.’’ The EPA provided information from the NTP 13th RoC which was released on October 2, 2014 (Ref. 2). The EPA’s evaluation of the data used to support the findings for 1bromopropane was conducted shortly after the release of the 13th RoC and completed on November 3, 2014 (Ref. 1). The EPA’s economic analysis of the potential costs of the proposed rule E:\FR\FM\23NOR1.SGM 23NOR1 Federal Register / Vol. 80, No. 225 / Monday, November 23, 2015 / Rules and Regulations including the estimate of the number of facilities expected to file reports was completed on February 17, 2015 (Ref. 8). The EPA notes that the commenter did not provide any comments specific to the EPA’s evaluation of the NTP 13th RoC data and findings for 1bromopropane (Ref. 1), which was reference 6 in the proposed rule (80 FR 20189, April 15, 2015), or specific to the NTP 13th RoC materials prepared for 1bromopropane (Refs. 10 and 11), which were references 5 and 7 in the proposed rule (80 FR 20189, April 15, 2015), or on the EPA’s economic analysis for the addition of 1-bromopropane (Ref. 8), which was reference 8 in the proposed rule (80 FR 20189, April 15, 2015). It is, therefore, unclear which technical information that the EPA submitted to support the proposed rule that the commenter believes is out of date, incorrect, or insufficient to support the proposed rule. Comments regarding the available cancer data and relevance of emissions data are discussed in other responses below. The Nestrud letter also provided comments concerning screening criteria that the EPA had used in a previous rulemaking: wgreen on DSK2VPTVN1PROD with RULES In its 1994 rulemaking EPA identified certain criteria it had developed to evaluate chemicals for additions to the list of toxic chemicals. This included a toxicity and production volume screen, and a hazard evaluation based on the initial screen. Addition of Certain Chemicals; Toxic Chemical Release Reporting; Community Right-to-Know; Final Rule (59 FR No. 229; Doc. No. 94–29376, November 30, 1994; OPPTS–400082B. Toxicity Screen. Through the toxicity screen a chemical is assigned a ‘‘high priority,’’ ‘‘medium priority,’’ or ‘‘low priority.’’ The attached comments submitted to EPA as part of the nPB Petition demonstrate that there is insufficient toxicity information to support assigning a ‘‘high priority,’’ or ‘‘medium priority’’ to nPB. The information that the commenter cited regarding the criteria the EPA identified for evaluating chemicals for addition to the EPCRA section 313 chemical list are the criteria the EPA used for its 1994 chemical expansion rulemaking to evaluate large numbers of chemicals for potential addition. These screening criteria are not the criteria used to determine whether or not a chemical can be added to the EPCRA section 313 chemical list, that criteria is established under EPCRA section 313(d)(2). As the EPA noted in the 1994 chemical expansion rule: A toxicity screen is a limited review of readily available toxicity data that is used for a preliminary categorization of a chemical during the process of selecting candidates for possible listing under EPCRA section 313. VerDate Sep<11>2014 13:22 Nov 20, 2015 Jkt 238001 The toxicity screen is used to identify chemicals for further consideration and does not reflect a final determination for listing a chemical under EPCRA section 313. Such a determination can only be made after a hazard assessment is conducted (See Unit 11.3. of this preamble). (59 FR 61433, November 30, 1994) EPA did not screen 1-bromopropane for addition, but rather conducted a hazard evaluation of the available cancer data and based on the classification by the NTP in their 13th RoC as ‘‘reasonably anticipated to be a human carcinogen’’ and our review of that data, concluded 1-bromopropane should be added to the EPCRA section 313 chemical list. As noted in the proposed rule, the EPA reviewed the data used by the NTP to make this determination and agreed with the NTP’s classification (Ref. 1), which was reference 6 in the proposed rule (80 FR 20189, April 15, 2015). As the EPA noted in the 1994 chemical expansion rule, cancer is an extreme toxic effect: In some cases the effects are extreme, such as cancer or death. (59 FR 61433, November 30, 1994) If the EPA had conducted a toxicity screen like that used in the 1994 chemical expansion rule, the available cancer data would have been sufficient to classify 1-bromopropane as a high priority for listing. In fact, the NTP’s 6th RoC was a primary source reviewed for chemicals for potential addition (59 FR 1789, January 12, 1994). As previously noted, the commenter did not provide any comments specifically on the NTP’s classification of 1-bromopropane as ‘‘reasonably anticipated to be a human carcinogen’’ in the 13th RoC, nor did they provide any comments on the EPA’s evaluation of the NTP cancer data and classification (Ref. 1), as provided in reference 6 of the proposed rule (80 FR 20189, April 15, 2015). The Nestrud letter also commented on the issue of a production volume screen: Production Volume Screen. When use of the chemical is less than the reporting thresholds, the chemical is ‘‘not considered further.’’ The attached comments submitted to EPA as part of the nPB Petition demonstrate that there are no facilities in the dry cleaning or spray adhesives industries that use more 1-bromopropane than the reporting threshold of 10,000 pounds (5 tons). Although the nPB Petition identified one facility in the metal cleaning industry that used more 1-bromopropane than the reporting threshold of 10,000 pounds (5 tons), that facility reported its use of nPB pursuant to its Title V Air Permit. Reference 8 in the proposed rule was the economic analysis for the addition of 1-bromopropane to the EPCRA section 313 chemical list (Ref. 8). As PO 00000 Frm 00011 Fmt 4700 Sfmt 4700 72909 indicated in the economic analysis, the EPA estimates that 140 reports (126 Form Rs and 14 Form As) from 23 different industry sectors will be filed for 1-bromopropane. Therefore, the EPA has determined that there is sufficient production and use of 1-bromopropane such that reports will be filed. As previously noted, the commenter provided no specific comments on the EPA’s economic analysis. Certain spray adhesives industries may be required to report under EPCRA section 313, but dry cleaning facilities are not a covered industry sector and thus are not required to file reports under EPCRA section 313. While it has been the EPA’s policy to focus on the addition of chemicals for which reports are expected to be filed, it is not a statutory requirement. As the EPA noted in the 2010 proposed rule for the addition of 16 NTP carcinogens to the EPCRA section 313 chemical list: Section 313(d)(2) of EPCRA provides EPA the discretion to add chemicals to the TRI list when there is sufficient evidence to establish any of the listing criteria. EPA can add a chemical that meets one criterion regardless of its production volume. (75 FR 17336, April 6, 2010) The Nestrud letter also commented on the issue of conducting a hazard evaluation to support the listing of 1bromopropane to the EPCRA section 313 list: Hazard Evaluation. Based on the results of the screen, EPA should conduct a Hazard Evaluation for 1-bromopropane. The attached comments submitted to EPA as part of the nPB Petition demonstrate that the weight of the evidence is not sufficient to add 1bromopropane to the list of toxic chemicals. In particular, the individual lifetime cancer risk at maximally impacted census receptors near the facilities that use 1-bromopropane is less than 1 in 1 million for all the facilities identified by EPA in the nPB Petition, with the exception of a narrow tube manufacturing facility, for which the maximum individual lifetime cancer risk is less than 1 in 100,000. Other than STC, there are no identified populations that would have a lifetime cancer risks from exposure to nPB in excess of 1 in 1 million. Accordingly, there is no information that would support adding 1-bromopropane to the list of toxic chemicals. The commenter states that the EPA should conduct a ‘‘Hazard Evaluation’’ for 1-bromopropane, but that is exactly what the EPA did. The EPA’s hazard evaluation included the NTP’s classification of 1-bromopropane as ‘‘reasonably anticipated to be a human carcinogen’’ (Refs. 2 and 10) and the EPA’s review of the data used by the NTP to support that classification (Ref. 1). As noted in the proposed rule, the NTP conducted an extensive review E:\FR\FM\23NOR1.SGM 23NOR1 72910 Federal Register / Vol. 80, No. 225 / Monday, November 23, 2015 / Rules and Regulations (including public comment and peer review) of the cancer data for 1bromopropane in making the classification for the NTP 13th RoC. The EPA’s review of that information, as discussed in reference 6 of the proposed rule, concluded that: The conclusions of the NTP RoC for 1bromopropane were consistent with how the Agency would consider the carcinogenicity data available for 1-bromopropane. Therefore, it would be appropriate for the Agency, for the purposes of listing 1bromopropane on the Toxics Release Inventory, to conclude that 1-bromopropane can reasonably be anticipated to cause cancer in humans. wgreen on DSK2VPTVN1PROD with RULES (80 FR 20189, April 15, 2015) EPA believes the cancer data for 1bromopropane sufficiently support listing under EPCRA section 313(d)(2)(B). None of the information concerning the cancer data that the commenter submitted in their response to the petition to add 1-bromopropane to the hazardous air pollutant (HAP) list changes the EPA’s conclusion with regard to the potential for 1bromopropane to cause cancer in humans. Responses to the specific comments on certain portions of the hazard evaluation are addressed in other responses. With regard to the commenter’s conclusions concerning the cancer risks from facilities identified in the HAP petition, this information is not relevant to the addition of 1-bromopropane to the EPCRA section 313 chemical list. The EPA did not base the proposed addition of 1-bromopropane to the EPCRA section 313 chemical list on any exposure or risk evaluation. 1Bromopropane meets the EPCRA section 313(d)(2)(B) listing criteria based on the cancer data alone and there are no statutory requirements to consider exposure or risk under EPCRA section 313(d)(2)(B). While the statutory criteria of EPCRA section 313(d)(2)(B) do not require consideration of exposure or risk, the EPA has a policy concerning when it may be appropriate to consider potential exposures when adding chemicals under EPCRA section 313(d)(2)(B). As the EPA stated in the proposed rule: 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 VerDate Sep<11>2014 13:22 Nov 20, 2015 Jkt 238001 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). (80 FR 20189, April 15, 2015) The EPA disagrees with the conclusion of the commenter that there is no information that would support adding 1-bromopropane to the EPCRA section 313 chemical list. In fact, it is the EPA’s position that there are extensive cancer data that support this addition as discussed and referenced in the proposed rule. In the comments the Albemarle Corporation submitted on the HAP listing petition (Ref. 6), the report by Gradient Corp. included section ‘‘2.2 Human Relevance of the Petitioner’s Inhalation Unit Risk Factor.’’ In that section, issues regarding the cancer data for 1-bromopropane were raised. These issues include the petitioners’ use of alveolar/bronchiolar adenomas and carcinomas in B6C3F1 mice for their risk assessment. The commenter took issue with the petitioners’ suggestion that ‘‘there are no reasons to assume that the mode, or modes, of action by which tumors are induced by nPB are not relevant to man.’’ The commenter stated that the petitioners’ supporting information lacked an analysis of the human relevance of the mouse lung tumors or any other cancer endpoint and cited recommendations in the EPA’s Guidelines for Carcinogen Risk Assessment for collecting relevant information on the mode of action. The commenter stated that alveolar/ bronchiolar adenomas and carcinomas have been reviewed and debated for a number of chemical compounds and were the subject of a 2014 technical workshop sponsored by the EPA. The commenter also provided summaries of relevant information that they claim are available for 1-bromopropane to explore mode of action questions. The commenter concluded that there is evidence that the mode of action for the endpoint selected to predict risks for 1bromopropane may not be relevant for humans. The commenter stated that, considering the state-of-the-science surrounding this health endpoint, the EPA should not rely on the data for alveolar/bronchiolar adenomas and carcinomas in B6C3F1 mice for characterizing cancer risks in humans from exposure to 1-bromopropane. As the EPA previously noted, the proposed addition of 1-bromopropane to the EPCRA section 313 chemical list is based on hazard alone and not on any consideration of exposures or potential risks. For the purposes of listing under EPCRA section 313(d)(2)(B), the EPA is PO 00000 Frm 00012 Fmt 4700 Sfmt 4700 not relying on the data for alveolar/ bronchiolar adenomas and carcinomas in B6C3F1 mice for characterizing cancer risks in humans from exposure to 1-bromopropane. While the EPA convened a technical workshop on the state-of-the-science for chemicallyinduced mouse lung tumors, there was no consensus on the relevance of this tumor to humans (Ref. 12). Rather, one of the workshop outcomes included the future application of the information discussed during the workshop to develop a mode of action framework on a chemical by chemical basis. As stated in the EPA Guidelines for Carcinogen Risk Assessment (Ref. 9): The default option is that positive effects in animal cancer studies indicate that the agent under study can have carcinogenic potential in humans. Thus, if no adequate human or mode of action data are present, positive effects in animal cancer studies are a basis for assessing the carcinogenic hazard to humans. The NTP monograph for 1bromopropane (Ref. 10) discussed the issue of mode of action in the section on mechanistic considerations: 5.3 Mechanistic considerations The biological events associated with chemically induced cancer are not completely understood even for chemicals that have been extensively studied and are known to cause cancer in humans (e.g., benzene and arsenic) (Guyton et al. 2009). It is important to recognize that chemicals can act through multiple toxicity pathways and mechanisms to induce cancer or other health effects, and the relative importance of the various pathways may vary with life stage, genetic background, and dose. Thus, it is unlikely that for any chemical a single mechanism or mode of action will fully explain the multiple biological alterations and toxicity pathways that can cause normal cells to transform and ultimately form a tumor. Although no studies were identified that were specifically designed to investigate possible modes of action for 1bromopropane-induced carcinogenesis, the available data indicate that metabolic activation, genetic damage, and oxidative stress from glutathione depletion are important factors. As discussed in the previous section, these factors were linked to several of the primary non-neoplastic toxic effects of 1-bromopropane, including immunosuppression, neurotoxicity, reproductive toxicity, and hepatotoxicity. Other factors that have been associated with carcinogenesis and may be relevant for 1bromopropane are discussed and include immune-response modulation, altered cell signaling and gene expression, inflammation, and cytotoxicity and compensatory cell proliferation. (Ref. 10, page 40) After considering the mode of action issues, the NTP classified 1- E:\FR\FM\23NOR1.SGM 23NOR1 wgreen on DSK2VPTVN1PROD with RULES Federal Register / Vol. 80, No. 225 / Monday, November 23, 2015 / Rules and Regulations bromopropane as ‘‘reasonably anticipated to be a human carcinogen.’’ The EPA believes that this classification is consistent with how the data would be evaluated under the EPA’s Guidelines for Carcinogen Risk Assessment (Ref. 9). In the comments the Albemarle Corporation submitted on the HAP listing petition, the report by Gradient Corp. included section ‘‘2.3 Human Relevance of NTP Results.’’ In that section, issues regarding the cancer data for 1-bromopropane were raised. The commenter stated that the petitioners cited NTP results for the mouse and rat bioassays as evidence of the potential carcinogenic activity of 1-bromopropane (Ref. 13). The commenter claims that the petitioner did not consider potential uncertainties that the commenter believes are found in the underlying mutagenicity, genotoxicity, and carcinogenicity data for 1bromopropane. The commenter claimed that this was not consistent with the EPA’s cancer guidelines, which recommend evaluating the weight of evidence prior to determining the carcinogenic potential of a chemical substance. The commenter went on to summarize information from studies they believe show potential uncertainties that are apparent in the toxicological information for 1bromopropane. Since the publication of the NTP bioassay cited by the commenter (Ref. 13), the NTP published its 13th RoC (Ref. 2). In this report, the NTP concluded that there is sufficient evidence of carcinogenicity for 1bromopropane based on (1) skin tumors in male rats, (2) tumors of the large intestine in female and male rats, and (3) lung tumors in female mice. The report also cited malignant mesothelioma of the abdominal cavity and pancreatic islet tumors in male rats and skin tumors (squamous-cell papilloma, keratoacanthoma, and basalcell adenoma or carcinoma) in female rats as supporting evidence. The NTP’s monograph for 1-bromopropane addresses all of the data issues that the commenter raised (Ref. 10). According to the EPA’s Guidelines for Carcinogen Risk Assessment (Ref. 9), an agent can be classified as ‘‘Likely to Be Carcinogenic to Humans’’ if it ‘‘has tested positive in animal experiments in more than one species, sex, strain, site, or exposure route, with or without evidence of carcinogenicity in humans.’’ Inconsistencies between how the data were interpreted by the NTP and how that same data might be interpreted under the EPA’s Guidelines for Carcinogen Risk Assessment (Ref. 9) VerDate Sep<11>2014 13:22 Nov 20, 2015 Jkt 238001 were not identified (see reference 6 in the proposed rule). The EPA Guidelines for Carcinogen Risk Assessment reference the NTP criteria for assessing individual studies in the assessment of carcinogenicity, stating ‘‘(c)riteria for the technical adequacy of animal carcinogenicity studies have been published and should be used as guidance to judge the acceptability of individual studies, e.g., NTP, 1984 . . .’’ (pages 2–16). While the EPA acknowledges that uncertainties exist when evaluating any agent, the EPA agrees with NTP’s assessment of the data and conclusions regarding the carcinogenicity of 1bromopropane. Indeed, according to the EPA’s Guidelines for Carcinogen Risk Assessment (Ref. 9) ‘‘The default option is that positive effects in animal cancer studies indicate that the agent under study can have carcinogenic potential in humans. Thus, if no adequate human or mode of action data are present, positive effects in animal cancer studies are a basis for assessing the carcinogenic hazard to humans.’’ The EPA believes that the evaluation of the available data are consistent with the EPA’s guidelines including the EPA’s ‘‘Supplemental guidance for assessing susceptibility from early-life exposure to carcinogens (Final)’’ (Ref. 14). The NTP in its monograph of 1bromopropane (Ref. 10), which supported the 13th RoC listing (Ref. 2), concluded the following: Studies in vivo show that 1-bromopropane can covalently bind to protein in exposed rats and occupationally exposed workers. The available data provide some support that 1-bromopropane is genotoxic as it induced mutations in bacterial and mammalian cells and DNA damage in human cells. There is limited evidence that DNA damage was induced in leukocytes from 1-bromopropaneexposed workers. 1-Bromopropane did not induce chromosomal damage in exposed rodents (micronucleus induction assay) or gene-cell mutations (dominant lethal mutation assay). Several known or postulated metabolites of 1-bromopropane have been identified as mutagens and two, glycidol and propylene oxide (proposed), were shown to cause chromosomal and DNA damage in cultured mammalian cells. Both metabolites caused chromosomal damage in cells from rodents exposed in vivo, and propylene oxide induced DNA damage in cells from exposed workers. Three other 1bromopropane metabolites (a-bromohydrin, 3-bromo-1-propanol, and 1-bromo-2propanol) were mutagenic or caused DNA damage in bacteria. The EPA agrees with the NTP’s conclusions regarding the mutagenicity of 1-bromopropane and its metabolites. With the exception of the summary information provided by the commenter for one unpublished study, all of the PO 00000 Frm 00013 Fmt 4700 Sfmt 4700 72911 studies cited by the commenter in their assessment of the mutagenicity data for 1-bromopropane were cited by the NTP in their monograph for 1-bromopropane (Ref. 10). Also, the commenter focused on the mutagenicity data for 1bromopropane, but the data on the mutagenicity of the metabolites of 1bromopropane are an important part of the assessment as well. The summarized results of the unpublished study provided by the commenter do not change the conclusion regarding the mutagenicity of 1-bromopropane and its metabolites. V. Summary of Final Rule The EPA is finalizing the addition of 1-bromopropane to the EPCRA section 313 list of toxic chemicals. The EPA has determined that 1-bromopropane meets the listing criteria under EPCRA section 313(d)(2)(B) based on the available carcinogenicity data. VI. References The 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 the 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 the 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 the 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. USEPA, OEI, 2014. 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 1bromopropane. 2. 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. (https:// ntp.niehs.nih.gov/pubhealth/roc/roc13/ index.html). 3. Anonymous public comment. April 15, 2015. EPA–HQ–TRI–2015–0011–0048. E:\FR\FM\23NOR1.SGM 23NOR1 wgreen on DSK2VPTVN1PROD with RULES 72912 Federal Register / Vol. 80, No. 225 / Monday, November 23, 2015 / Rules and Regulations 4. Anonymous public comment. April 16, 2015. EPA–HQ–TRI–2015–0011–0049. 5. Comment submitted by Faye Graul, Executive Director, Halogenated Solvents Industry Alliance Incorporated (HSIA). Re: Docket ID No. EPA–HQ–TRI–2015– 0011. June 15, 2015. EPA–HQ–TRI– 2015–0011–0051. 6. Comment submitted by Niomi Krzystowczyk, Vice President, Health, Safety and Environment, Albemarle Corporation. Re: Proposed Rule: Addition of 1-Bromopropane; Community Right-to-Know Toxic Chemical Release Reporting; Docket ID No. EPA–HQ–TRI–2015–0011 [FRL– 9925–29–OEI, 80 FR 20189 (April 15, 2015). June 10, 2015. EPA–HQ–TRI– 2015–0011–0050. 7. USEPA, OEI, 2015. Response to Comments Received on the April 15, 2015, Federal Register Proposed Rule (80 FR 20189): Addition of 1-Bromopropane; Community Right-to-Know Toxic Chemical Release Reporting. U.S. Environmental Protection Agency Office of Environmental Information, Office of Information Analysis and Access. August 20, 2015. 8. USEPA, OEI, 2015. Economic Analysis of the Proposed Rule to add 1Bromopropane to the EPCRA Section 313 List of Toxic Chemicals. February 17, 2015. 9. USEPA, 2005. Guidelines for Carcinogen Risk Assessment. Risk Assessment Forum, U.S. Environmental Protection Agency, Washington, DC, March 2005. EPA/630/P–03/001F. 10. 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. 11. 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. 12. USEPA, 2014. Summary Report of the State-of-the-Science Workshop on Chemically-induced Mouse Lung Tumors: Applications to Human Health Assessments. National Center for Environmental Assessment, Washington, DC, December 2014. EPA/600/R–14/002. 13. NTP, 2011. Technical Report on the Toxicology and Carcinogenesis Studies of 1-Bromopropane (CAS No. 106–94–5) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). Toxicity Report Series No. 564. NIH Publication No. 11– 5906. Department of Health and Human Services, Public Health Service, Research Triangle Park, NC. 14. USEPA, 2005. Supplemental guidance for assessing susceptibility from early-life exposure to carcinogens (Final). Risk Assessment Forum, Washington, DC, March 2005. EPA/630/R–03/003F. VerDate Sep<11>2014 13:22 Nov 20, 2015 Jkt 238001 VII. What are the statutory and Executive Order reviews associated with this action? Additional information about these statutes and Executive Orders can be found at https://www2.epa.gov/lawsregulations/laws-and-executive-orders. 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, the 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 PO 00000 Frm 00014 Fmt 4700 Sfmt 4700 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 the 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 small entities subject to the requirements of this action are small manufacturing facilities. The Agency has determined that of the 140 entities estimated to be impacted by this action, 136 are small businesses; no small 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 the 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. 1531–1538, 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. The 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 E:\FR\FM\23NOR1.SGM 23NOR1 72913 Federal Register / Vol. 80, No. 225 / Monday, November 23, 2015 / Rules and Regulations 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 K. Congressional Review Act (CRA) 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, the 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. This action is subject to the CRA, and the EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 372 Environmental protection, Community right-to-know, Reporting and recordkeeping requirements, and Toxic chemicals. Dated: November 9, 2015. Gina McCarthy, Administrator. For the reasons set forth in the preamble, the EPA amends 40 CFR part 372 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. * * * * * 1-Bromopropane ...................................................................................................................................................... * * * * * * * * * * * Effective date 106–94–5 * 1/1/16 * * * (b) * * * Chemical name Effective date * * 106–94–5 .................................................. wgreen on DSK2VPTVN1PROD with RULES CAS No. * * * * 1-Bromopropane .......................................................................................................... * 1/1/16 * * * * * * * * * * * [FR Doc. 2015–29799 Filed 11–20–15; 8:45 am] BILLING CODE 6560–50–P VerDate Sep<11>2014 17:35 Nov 20, 2015 Jkt 238001 PO 00000 Frm 00015 Fmt 4700 Sfmt 4700 E:\FR\FM\23NOR1.SGM 23NOR1 * 72914 Federal Register / Vol. 80, No. 225 / Monday, November 23, 2015 / Rules and Regulations DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration 49 CFR Parts 171, 172, 173, 175, 176, 177, 178 and 180 [Docket No. PHMSA–2015–0103 (HM–260)] RIN 2137–AF11 Hazardous Materials: Editorial Corrections and Clarifications (RRR) Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT. ACTION: Final rule. AGENCY: This final rule corrects editorial errors, makes minor regulatory changes and, in response to requests for clarification, improves the clarity of certain provisions in the Hazardous Materials Regulations. The intended effect of this rule is to enhance the accuracy and reduce misunderstandings of the regulations. The amendments contained in this rule are nonsubstantive changes and do not impose new requirements. DATES: This regulation is effective December 23, 2015. FOR FURTHER INFORMATION CONTACT: Aaron Wiener, Standards and Rulemaking Division, (202) 366–8553, Pipeline and Hazardous Materials Safety Administration, U.S. Department of Transportation, 1200 New Jersey Avenue SE., 2nd Floor, Washington, DC 20590–0001. SUPPLEMENTARY INFORMATION: SUMMARY: wgreen on DSK2VPTVN1PROD with RULES I. Background II. Section-by-Section Review III. Regulatory Analyses and Notices A. Statutory/Legal Authority for the Rulemaking B. Executive Orders 12866 and 13563 and DOT Regulatory Policies and Procedures C. Executive Order 13132 D. Executive Order 13175 E. Regulatory Flexibility Act, Executive Order 13272, and DOT Policies and Procedures F. Executive Order 13563 Improving Regulation and Regulatory Review G. Paperwork Reduction Act H. Regulatory Identifier Number (RIN) I. Unfunded Mandates Reform Act J. Environmental Assessment K. Privacy Act I. Background The Pipeline and Hazardous Materials Safety Administration (PHMSA) annually reviews the Hazardous Materials Regulations (HMR; 49 CFR parts 171–180) to identify typographical errors, outdated addresses or other VerDate Sep<11>2014 17:35 Nov 20, 2015 Jkt 238001 contact information, and similar errors. In this final rule, we are correcting typographical errors, incorrect references to the Code of Federal Regulations (CFR) and international standards citations, inconsistent use of terminology, misstatements of certain regulatory requirements, and inadvertent omissions of information, and making revisions to clarify the regulations. Of the corrections and clarifications made in this final rule, a significant number originate from three recent final rules under the following dockets: PHMSA–2009–0063 (HM–250) [79 FR 40590]; PHMSA–2009–0095 (HM–224F)] [79 FR 46012]; and PHMSA–2013–0260 (HM–215M) [80 FR 1075]. Because these amendments do not impose new requirements, notice and public comment are unnecessary. II. Section-by-Section Review The following is a section-by-section summary of the minor editorial corrections and clarifications made in this final rule. Part 171 Section 171.22 This section prescribes the authorization and conditions for use of international standards and regulations. The wording at the end of paragraph (f)(4) applicable to shipping paper retention, states ‘‘§ 172.201(e) of this part’’, which incorrectly assigns it to 49 CFR part 171. As § 172.201(e), is not in part 171, in this final rule, the text is revised to read ‘‘§ 172.201(e) of this subchapter.’’ Section 171.23 Section 171.23 prescribes requirements for specific materials and packagings transported under various international standards. Paragraph (a)(4)(ii) contains a grammatical error stating the word ‘‘drive’’ instead of ‘‘device.’’ In this final rule, we are correcting this grammatical error. Additionally, the text in the middle of paragraph (a)(5), applicable to cylinders not equipped with pressure relief devices, states the cylinders must be ‘‘tested and marked in accordance with part 178 of this subchapter and otherwise conforms to the requirements of part 173 for the gas involved’’, but does not reference that part 173 belongs to subchapter C. In this final rule, we are revising (a)(5) to make this clarification. Section 171.24 Section 171.24 provides additional requirements for the use of the International Civil Aviation PO 00000 Frm 00016 Fmt 4700 Sfmt 4700 Organization’s Technical Instructions (ICAO TI) for the Safe Transport of Dangerous Goods by Air. The text at the end of paragraph (c), applicable to transportation by highway prior to or after transportation by aircraft, states a ‘‘motor vehicle must be placarded in accordance with subpart F of part 172’’, but does not reference that part 172 belongs to Subchapter C. In this final rule, we are revising paragraph (c) to make this clarification. Part 172 Section 172.101 This section prescribes the purpose and instructions for use of the § 172.102 Hazardous Materials Table (HMT). We are making a number of editorial corrections to several entries in the HMT. The editorial corrections are as follows: • In a final rule published under Docket Number PHMSA–2012–0080 (HM–244E) [77 FR 60935], the entry for ‘‘Aminophenols (o-; m-; p-), UN2512’’ was amended to correct a publication error in Column (2). In making the correction, the text in Columns (3) through (10B) was inadvertently removed and left blank. This final rule corrects that error by reinstating the text in Columns (3) through (10B) for UN2512 as it read on prior to the HM– 244E rulemaking October 5, 2012. Amendments to Column (1) Symbols • For the entry ‘‘Environmentally hazardous substances, solid, n.o.s, UN3077,’’ the symbol ‘‘G’’ is added to Column (1) as it was inadvertently removed when the entry was amended in a final rule published under Docket Number PHMSA 2011–0158 (HM–233C) [79 FR 15033]. • For the entry ‘‘Self-heating solid, organic, n.o.s, UN3088,’’ the symbol ‘‘G’’ is added to Column (1) as it was inadvertently removed when the entry was amended in a final rule published under Docket Number PHMSA 2011– 0158 (HM–233C) [79 FR 15033]. Amendments to Column (2) Hazardous Materials Descriptions and Proper Shipping Names • For the entry ‘‘N-Aminoethyl piperazine, UN2815,’’ the space between ‘‘N-Aminoethyl’’ and ‘‘piperazine’’ is removed to read ‘‘NAminoethylpiperazine’’ as the space was inadvertently introduced in the HM–215M final rule. E:\FR\FM\23NOR1.SGM 23NOR1

Agencies

[Federal Register Volume 80, Number 225 (Monday, November 23, 2015)]
[Rules and Regulations]
[Pages 72906-72914]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-29799]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 372

[EPA-HQ-TRI-2015-0011; FRL-9937-12-OEI]
RIN 2025-AA41


Addition of 1-Bromopropane; Community Right-to-Know Toxic 
Chemical Release Reporting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is adding 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.'' The EPA has determined that 1-bromopropane 
meets the EPCRA section 313(d)(2)(B) criteria because it can reasonably 
be anticipated to cause cancer in humans.

DATES: This final rule is effective November 30, 2015, and shall apply 
for the reporting year beginning January 1, 2016 (reports due July 1, 
2017).

ADDRESSES: The EPA has established a docket for this action under 
Docket ID No. EPA-HQ-TRI-2015-0011. All documents in the docket are 
listed on the https://www.regulations.gov Web site. Although listed in 
the index, some information is not publicly available, e.g., 
Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Certain other material, such as 
copyrighted material, is not placed on the Internet and will be 
publicly available only in hard copy form. Publicly available docket 
materials are available electronically through https://www.regulations.gov.

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, https://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:

------------------------------------------------------------------------
                                      Examples of potentially affected
             Category                             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, 221118, 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

[[Page 72907]]

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 308 individually listed chemicals and 20 
chemical categories.
    EPCRA section 313(d) authorizes the EPA to add or delete chemicals 
from the list and sets criteria for these actions. EPCRA section 
313(d)(2) states that the 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, the 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 the EPA must demonstrate that none of the listing criteria in 
Section 313(d)(2)(A)-(C) are met. The EPCRA section 313(d)(2)(A)-(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:
[cir] Cancer or teratogenic effects, or
[cir] serious or irreversible--

    [ssquf] Reproductive dysfunctions,
    [ssquf] neurological disorders,
    [ssquf] heritable genetic mutations, or
    [ssquf] other chronic health effects.
     The chemical is known to cause or can be reasonably 
anticipated to cause, because of:
    [cir] Its toxicity,
    [cir] its toxicity and persistence in the environment, or
    [cir] 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.
    The 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.''
    The 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. Summary of Proposed Rule

A. What chemical did the EPA propose to add to the EPCRA section 313 
list of toxic chemicals?

    As discussed in the proposed rule (80 FR 20189, April 15, 2015), 
the EPA proposed to add 1-bromopropane to the EPCRA section 313 list of 
toxic chemicals. 1-Bromopropane had been classified as ``reasonably 
anticipated to be a human carcinogen'' by the National Toxicology 
Program (NTP) in its 13th Report on Carcinogens (RoC) document. In 
addition, based on a review of the available production and use 
information, the EPA determined that 1-bromopropane is 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 
the NTP's cancer evaluation work, it 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 the EPA), 
and nongovernmental institutions. The RoC review process also includes 
external peer review and several opportunities for public comment.

B. What was the EPA's rationale for proposing to list 1-bromopropane?

    As the EPA stated in the proposed rule (80 FR 20189, April 15, 
2015), the NTP RoC document undergoes significant scientific review and 
public comment and mirrors the review the 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. The 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 the EPA's 
review of the data contained in the 13th NTP RoC (Reference (Ref.) 1) 
for 1-bromopropane, the Agency agreed that 1-bromopropane can 
reasonably be anticipated to cause cancer. Therefore, the EPA 
determined that the evidence was 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 for 1-
bromopropane as presented in the 13th RoC (Ref. 2).

IV. What comments did the EPA receive on the proposed rule?

    The EPA received four comments on the proposed rule to add 1-
bromopropane to the EPCRA section 313 chemical list. Three of the 
comments were supportive of the EPA's proposed addition of 1-
bromopropane while one commenter objected to the addition. The 
commenters that supported the proposed rule included two anonymous 
comments from the general public (Refs. 3 and 4) and a comment from the 
Halogenated Solvents Industry Alliance, Inc. (HSIA) (Ref. 5). Members 
of the HSIA include The Dow Chemical Company, INEOS Chlor Americas, 
Inc., Occidental Chemical, and Axiall Corporation. The commenter who 
objected to the addition was the Albemarle Corporation (Ref. 6). The 
most significant comments are summarized and responded to below. The 
complete set of comments and the EPA's responses can be found in the 
response to comment document in the docket for this rulemaking (Ref. 
7). Note that in some of the comments 1-bromopropane is referred to as 
nPB, which is the acronym for the alternative chemical name n-propyl 
bromide.
    The HSIA (Ref. 5) stated that the proposed rule presented 
substantial

[[Page 72908]]

evidence to support the conclusion that 1-bromopropane is known to 
cause or can reasonably be anticipated to cause cancer in humans. The 
HSIA also noted that other published studies indicate that 1-
bromopropane is neurotoxic, may cause reproductive dysfunction, and is 
acutely or chronically toxic. The HSIA concluded that clearly, the 
scientific literature supports the addition of 1-bromopropane to the 
list of chemicals subject to reporting under EPCRA section 313.
    EPA agrees with the commenter's statement that the EPA provided 
substantial evidence to support the conclusion that 1-bromopropane is 
known to cause or can reasonably be anticipated to cause cancer in 
humans. The EPA also agrees with the commenter's conclusion that the 
scientific literature supports the addition of 1-bromopropane to the 
EPCRA section 313 chemical list. The EPA acknowledges that there may be 
other toxicological effects that may also be a basis for listing. 
However, the EPA believes the available cancer data are sufficient for 
adding 1-bromopropane to the EPCRA section 313 chemical list.
    The first anonymous commenter (Ref. 3) supported the addition of 1-
bromopropane to the EPCRA section 313 list and cited additional 
toxicity information, neurotoxicity and reproductive toxicity, as being 
of concern.
    EPA agrees that 1-bromopropane should be added to the EPCRA section 
313 chemical list. The EPA also acknowledges that there may be other 
toxicological effects (such as neurotoxicity) that may also be a basis 
for listing. However, the available cancer data are sufficient for 
adding 1-bromopropane to the EPCRA section 313 chemical list.
    The second anonymous commenter (Ref. 4) supported the listing of 1-
bromopropane as long as the benefits substantially outweigh the costs. 
The commenter also expressed concern that there may be ``significant 
costs to local businesses, i.e., laundry services, that have to update 
or replace their equipment as well as significant costs and time spent 
in order to comply with the rule.''
    EPA's cost-benefit analysis was contained in the economic analysis 
for the proposed rule ``Economic Analysis of the Proposed Rule to add 
1-Bromopropane to the EPCRA Section 313 List of Toxic Chemicals'' (Ref. 
8), which was reference 8 in the proposed rule (80 FR 20189, April 15, 
2015). The economic analysis contains a quantitative estimate of the 
costs and a qualitative discussion of the benefits of the rule. The EPA 
considers the benefits of reporting under this rule to be primarily 
reflected by the purposes served by reporting of information under 
EPCRA section 313. The EPA believes the benefits provided by the 
information to be reported under this rule outweigh the costs.
    With regard to laundry services (such as dry cleaners) these 
facilities are not subject to reporting under EPCRA section 313. Even 
if such facilities were subject to reporting, listing a chemical under 
EPCRA section 313 does not require covered facilities to update or 
replace any equipment. EPCRA section 313 only requires the reporting of 
release and waste management information, it does not impose any 
restrictions on the use of chemicals.
    The majority of comments provided by the Albemarle Corporation 
(Ref. 6) are the same comments they submitted in response to the 
``Receipt of a complete petition'' to add 1-bromopropane to the 
Hazardous Air Pollutant (HAP) List (80 FR 6676, February 6, 2015). The 
only comments submitted by the Albemarle Corporation specific to the 
EPA's proposed rule to add 1-bromopropane to the EPCRA section 313 
chemical list were provided in a letter from Charles R. Nestrud of the 
law firm Chisenhall, Nestrud & Julian, P.A. dated June 10, 2015 
(Nestrud letter). The EPA is providing responses to all of the comments 
in the Nestrud letter.
    The vast majority of the comments submitted by the Albemarle 
Corporation on the HAP listing petition dealt with issues of emissions, 
exposure, risk values, and risk assessment, which are not relevant to 
the proposed addition of 1-bromopropane to the EPCRA section 313 
chemical list since the addition is based on hazard and not risk. The 
addition of 1-bromopropane to the EPCRA section 313 chemical list is 
based on the cancer hazard evaluation carried out by the NTP and 
reviewed by the EPA to ensure its consistency with the EPA Guidelines 
for Carcinogen Risk Assessment (Ref. 9). Consistent with the EPA 
guidelines (Ref. 9), the NTP 13th RoC (Ref. 2) evaluates the scientific 
literature and publicly available, peer-reviewed technical reports of 
human and laboratory studies to evaluate whether substances are 
possible human carcinogens. The NTP RoC does not present a quantitative 
assessment of the risks of cancer associated with a given chemical. 
Rather, it indicates the potential hazard associated with chemicals but 
does not establish the exposure conditions that would pose cancer risks 
to individuals. In the 13th RoC, the NTP classified 1-bromopropane as 
``reasonably anticipated to be a human carcinogen.'' The conclusions of 
the NTP 13th RoC for 1-bromopropane were consistent with how the EPA 
would consider the carcinogenicity data available for 1-bromopropane. 
Therefore, for the purposes of listing 1-bromopropane on the EPCRA 
section 313 chemical list, the EPA concluded that 1-bromopropane can 
reasonably be anticipated to cause cancer in humans. Since the listing 
of 1-bromopropane under EPCRA section 313 is based on the available 
cancer data, the EPA is not responding to the comments from Albemarle 
Corporation on the HAP listing petition that dealt with issues of 
emissions, exposure, risk values, and risk assessment.
    While not specific to the materials the EPA cited to support the 
addition of 1-bromopropane to the EPCRA section 313 chemical list, 
there were some comments on the cancer data for 1-bromopropane in the 
materials that the Albemarle Corporation submitted in response to the 
HAP listing petition (Ref. 6). Specifically, these comments are 
contained in sections 2.2 and 2.3 of the document ``Comments on the 
Petition to Add n-Propyl Bromide to the List of Hazardous Air 
Pollutants Regulated under Sec.  112 of the Clean Air Act'' prepared by 
the Gradient Corporation (Gradient Corp.). Since these comments dealt 
with the toxic endpoint (cancer) that is the basis for the addition of 
1-bromopropane to the EPCRA section 313 chemical list, the EPA has 
addressed these comments as well.
    In the Nestrud letter, the commenter stated that:

    The comments prepared by Albemarle and its consultants 
demonstrate that the technical information submitted to support the 
Proposed Rule is out of date, incorrect, and insufficient to support 
the Proposed Rule. Furthermore, when all toxicological data is 
considered, and current emission data is considered, the weight of 
the evidence does not support adding 1-bromopropane to the list of 
toxic chemicals.

    EPA disagrees that the information submitted to support the 
proposed rule to add 1-bromopropane to the EPCRA section 313 chemical 
list is ``out of date, incorrect, and insufficient to support the 
Proposed Rule.'' The EPA provided information from the NTP 13th RoC 
which was released on October 2, 2014 (Ref. 2). The EPA's evaluation of 
the data used to support the findings for 1-bromopropane was conducted 
shortly after the release of the 13th RoC and completed on November 3, 
2014 (Ref. 1). The EPA's economic analysis of the potential costs of 
the proposed rule

[[Page 72909]]

including the estimate of the number of facilities expected to file 
reports was completed on February 17, 2015 (Ref. 8). The EPA notes that 
the commenter did not provide any comments specific to the EPA's 
evaluation of the NTP 13th RoC data and findings for 1-bromopropane 
(Ref. 1), which was reference 6 in the proposed rule (80 FR 20189, 
April 15, 2015), or specific to the NTP 13th RoC materials prepared for 
1-bromopropane (Refs. 10 and 11), which were references 5 and 7 in the 
proposed rule (80 FR 20189, April 15, 2015), or on the EPA's economic 
analysis for the addition of 1-bromopropane (Ref. 8), which was 
reference 8 in the proposed rule (80 FR 20189, April 15, 2015). It is, 
therefore, unclear which technical information that the EPA submitted 
to support the proposed rule that the commenter believes is out of 
date, incorrect, or insufficient to support the proposed rule. Comments 
regarding the available cancer data and relevance of emissions data are 
discussed in other responses below.
    The Nestrud letter also provided comments concerning screening 
criteria that the EPA had used in a previous rulemaking:

    In its 1994 rulemaking EPA identified certain criteria it had 
developed to evaluate chemicals for additions to the list of toxic 
chemicals. This included a toxicity and production volume screen, 
and a hazard evaluation based on the initial screen. Addition of 
Certain Chemicals; Toxic Chemical Release Reporting; Community 
Right-to-Know; Final Rule (59 FR No. 229; Doc. No. 94-29376, 
November 30, 1994; OPPTS-400082B.
    Toxicity Screen. Through the toxicity screen a chemical is 
assigned a ``high priority,'' ``medium priority,'' or ``low 
priority.'' The attached comments submitted to EPA as part of the 
nPB Petition demonstrate that there is insufficient toxicity 
information to support assigning a ``high priority,'' or ``medium 
priority'' to nPB.

    The information that the commenter cited regarding the criteria the 
EPA identified for evaluating chemicals for addition to the EPCRA 
section 313 chemical list are the criteria the EPA used for its 1994 
chemical expansion rulemaking to evaluate large numbers of chemicals 
for potential addition. These screening criteria are not the criteria 
used to determine whether or not a chemical can be added to the EPCRA 
section 313 chemical list, that criteria is established under EPCRA 
section 313(d)(2). As the EPA noted in the 1994 chemical expansion 
rule:

    A toxicity screen is a limited review of readily available 
toxicity data that is used for a preliminary categorization of a 
chemical during the process of selecting candidates for possible 
listing under EPCRA section 313. The toxicity screen is used to 
identify chemicals for further consideration and does not reflect a 
final determination for listing a chemical under EPCRA section 313. 
Such a determination can only be made after a hazard assessment is 
conducted (See Unit 11.3. of this preamble).

(59 FR 61433, November 30, 1994)

    EPA did not screen 1-bromopropane for addition, but rather 
conducted a hazard evaluation of the available cancer data and based on 
the classification by the NTP in their 13th RoC as ``reasonably 
anticipated to be a human carcinogen'' and our review of that data, 
concluded 1-bromopropane should be added to the EPCRA section 313 
chemical list. As noted in the proposed rule, the EPA reviewed the data 
used by the NTP to make this determination and agreed with the NTP's 
classification (Ref. 1), which was reference 6 in the proposed rule (80 
FR 20189, April 15, 2015). As the EPA noted in the 1994 chemical 
expansion rule, cancer is an extreme toxic effect:

    In some cases the effects are extreme, such as cancer or death.

(59 FR 61433, November 30, 1994)

    If the EPA had conducted a toxicity screen like that used in the 
1994 chemical expansion rule, the available cancer data would have been 
sufficient to classify 1-bromopropane as a high priority for listing. 
In fact, the NTP's 6th RoC was a primary source reviewed for chemicals 
for potential addition (59 FR 1789, January 12, 1994). As previously 
noted, the commenter did not provide any comments specifically on the 
NTP's classification of 1-bromopropane as ``reasonably anticipated to 
be a human carcinogen'' in the 13th RoC, nor did they provide any 
comments on the EPA's evaluation of the NTP cancer data and 
classification (Ref. 1), as provided in reference 6 of the proposed 
rule (80 FR 20189, April 15, 2015).
    The Nestrud letter also commented on the issue of a production 
volume screen:

    Production Volume Screen. When use of the chemical is less than 
the reporting thresholds, the chemical is ``not considered 
further.'' The attached comments submitted to EPA as part of the nPB 
Petition demonstrate that there are no facilities in the dry 
cleaning or spray adhesives industries that use more 1-bromopropane 
than the reporting threshold of 10,000 pounds (5 tons). Although the 
nPB Petition identified one facility in the metal cleaning industry 
that used more 1-bromopropane than the reporting threshold of 10,000 
pounds (5 tons), that facility reported its use of nPB pursuant to 
its Title V Air Permit.

    Reference 8 in the proposed rule was the economic analysis for the 
addition of 1-bromopropane to the EPCRA section 313 chemical list (Ref. 
8). As indicated in the economic analysis, the EPA estimates that 140 
reports (126 Form Rs and 14 Form As) from 23 different industry sectors 
will be filed for 1-bromopropane. Therefore, the EPA has determined 
that there is sufficient production and use of 1-bromopropane such that 
reports will be filed. As previously noted, the commenter provided no 
specific comments on the EPA's economic analysis. Certain spray 
adhesives industries may be required to report under EPCRA section 313, 
but dry cleaning facilities are not a covered industry sector and thus 
are not required to file reports under EPCRA section 313. While it has 
been the EPA's policy to focus on the addition of chemicals for which 
reports are expected to be filed, it is not a statutory requirement. As 
the EPA noted in the 2010 proposed rule for the addition of 16 NTP 
carcinogens to the EPCRA section 313 chemical list:

    Section 313(d)(2) of EPCRA provides EPA the discretion to add 
chemicals to the TRI list when there is sufficient evidence to 
establish any of the listing criteria. EPA can add a chemical that 
meets one criterion regardless of its production volume.

(75 FR 17336, April 6, 2010)

    The Nestrud letter also commented on the issue of conducting a 
hazard evaluation to support the listing of 1-bromopropane to the EPCRA 
section 313 list:

    Hazard Evaluation. Based on the results of the screen, EPA 
should conduct a Hazard Evaluation for 1-bromopropane. The attached 
comments submitted to EPA as part of the nPB Petition demonstrate 
that the weight of the evidence is not sufficient to add 1-
bromopropane to the list of toxic chemicals. In particular, the 
individual lifetime cancer risk at maximally impacted census 
receptors near the facilities that use 1-bromopropane is less than 1 
in 1 million for all the facilities identified by EPA in the nPB 
Petition, with the exception of a narrow tube manufacturing 
facility, for which the maximum individual lifetime cancer risk is 
less than 1 in 100,000. Other than STC, there are no identified 
populations that would have a lifetime cancer risks from exposure to 
nPB in excess of 1 in 1 million.
    Accordingly, there is no information that would support adding 
1-bromopropane to the list of toxic chemicals.

    The commenter states that the EPA should conduct a ``Hazard 
Evaluation'' for 1-bromopropane, but that is exactly what the EPA did. 
The EPA's hazard evaluation included the NTP's classification of 1-
bromopropane as ``reasonably anticipated to be a human carcinogen'' 
(Refs. 2 and 10) and the EPA's review of the data used by the NTP to 
support that classification (Ref. 1). As noted in the proposed rule, 
the NTP conducted an extensive review

[[Page 72910]]

(including public comment and peer review) of the cancer data for 1-
bromopropane in making the classification for the NTP 13th RoC. The 
EPA's review of that information, as discussed in reference 6 of the 
proposed rule, concluded that:

    The conclusions of the NTP RoC for 1-bromopropane were 
consistent with how the Agency would consider the carcinogenicity 
data available for 1-bromopropane. Therefore, it would be 
appropriate for the Agency, for the purposes of listing 1-
bromopropane on the Toxics Release Inventory, to conclude that 1-
bromopropane can reasonably be anticipated to cause cancer in 
humans.

(80 FR 20189, April 15, 2015)

    EPA believes the cancer data for 1-bromopropane sufficiently 
support listing under EPCRA section 313(d)(2)(B). None of the 
information concerning the cancer data that the commenter submitted in 
their response to the petition to add 1-bromopropane to the hazardous 
air pollutant (HAP) list changes the EPA's conclusion with regard to 
the potential for 1-bromopropane to cause cancer in humans. Responses 
to the specific comments on certain portions of the hazard evaluation 
are addressed in other responses.
    With regard to the commenter's conclusions concerning the cancer 
risks from facilities identified in the HAP petition, this information 
is not relevant to the addition of 1-bromopropane to the EPCRA section 
313 chemical list. The EPA did not base the proposed addition of 1-
bromopropane to the EPCRA section 313 chemical list on any exposure or 
risk evaluation. 1-Bromopropane meets the EPCRA section 313(d)(2)(B) 
listing criteria based on the cancer data alone and there are no 
statutory requirements to consider exposure or risk under EPCRA section 
313(d)(2)(B). While the statutory criteria of EPCRA section 
313(d)(2)(B) do not require consideration of exposure or risk, the EPA 
has a policy concerning when it may be appropriate to consider 
potential exposures when adding chemicals under EPCRA section 
313(d)(2)(B). As the EPA stated in the proposed rule:

    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).

(80 FR 20189, April 15, 2015)

    The EPA disagrees with the conclusion of the commenter that there 
is no information that would support adding 1-bromopropane to the EPCRA 
section 313 chemical list. In fact, it is the EPA's position that there 
are extensive cancer data that support this addition as discussed and 
referenced in the proposed rule.
    In the comments the Albemarle Corporation submitted on the HAP 
listing petition (Ref. 6), the report by Gradient Corp. included 
section ``2.2 Human Relevance of the Petitioner's Inhalation Unit Risk 
Factor.'' In that section, issues regarding the cancer data for 1-
bromopropane were raised. These issues include the petitioners' use of 
alveolar/bronchiolar adenomas and carcinomas in B6C3F1 mice for their 
risk assessment. The commenter took issue with the petitioners' 
suggestion that ``there are no reasons to assume that the mode, or 
modes, of action by which tumors are induced by nPB are not relevant to 
man.'' The commenter stated that the petitioners' supporting 
information lacked an analysis of the human relevance of the mouse lung 
tumors or any other cancer endpoint and cited recommendations in the 
EPA's Guidelines for Carcinogen Risk Assessment for collecting relevant 
information on the mode of action. The commenter stated that alveolar/
bronchiolar adenomas and carcinomas have been reviewed and debated for 
a number of chemical compounds and were the subject of a 2014 technical 
workshop sponsored by the EPA. The commenter also provided summaries of 
relevant information that they claim are available for 1-bromopropane 
to explore mode of action questions. The commenter concluded that there 
is evidence that the mode of action for the endpoint selected to 
predict risks for 1-bromopropane may not be relevant for humans. The 
commenter stated that, considering the state-of-the-science surrounding 
this health endpoint, the EPA should not rely on the data for alveolar/
bronchiolar adenomas and carcinomas in B6C3F1 mice for characterizing 
cancer risks in humans from exposure to 1-bromopropane.
    As the EPA previously noted, the proposed addition of 1-
bromopropane to the EPCRA section 313 chemical list is based on hazard 
alone and not on any consideration of exposures or potential risks. For 
the purposes of listing under EPCRA section 313(d)(2)(B), the EPA is 
not relying on the data for alveolar/bronchiolar adenomas and 
carcinomas in B6C3F1 mice for characterizing cancer risks in humans 
from exposure to 1-bromopropane. While the EPA convened a technical 
workshop on the state-of-the-science for chemically-induced mouse lung 
tumors, there was no consensus on the relevance of this tumor to humans 
(Ref. 12). Rather, one of the workshop outcomes included the future 
application of the information discussed during the workshop to develop 
a mode of action framework on a chemical by chemical basis. As stated 
in the EPA Guidelines for Carcinogen Risk Assessment (Ref. 9):

    The default option is that positive effects in animal cancer 
studies indicate that the agent under study can have carcinogenic 
potential in humans. Thus, if no adequate human or mode of action 
data are present, positive effects in animal cancer studies are a 
basis for assessing the carcinogenic hazard to humans.

    The NTP monograph for 1-bromopropane (Ref. 10) discussed the issue 
of mode of action in the section on mechanistic considerations:

5.3 Mechanistic considerations

    The biological events associated with chemically induced cancer 
are not completely understood even for chemicals that have been 
extensively studied and are known to cause cancer in humans (e.g., 
benzene and arsenic) (Guyton et al. 2009). It is important to 
recognize that chemicals can act through multiple toxicity pathways 
and mechanisms to induce cancer or other health effects, and the 
relative importance of the various pathways may vary with life 
stage, genetic background, and dose. Thus, it is unlikely that for 
any chemical a single mechanism or mode of action will fully explain 
the multiple biological alterations and toxicity pathways that can 
cause normal cells to transform and ultimately form a tumor.
    Although no studies were identified that were specifically 
designed to investigate possible modes of action for 1-bromopropane-
induced carcinogenesis, the available data indicate that metabolic 
activation, genetic damage, and oxidative stress from glutathione 
depletion are important factors. As discussed in the previous 
section, these factors were linked to several of the primary non-
neoplastic toxic effects of 1-bromopropane, including 
immunosuppression, neurotoxicity, reproductive toxicity, and 
hepatotoxicity. Other factors that have been associated with 
carcinogenesis and may be relevant for 1-bromopropane are discussed 
and include immune-response modulation, altered cell signaling and 
gene expression, inflammation, and cytotoxicity and compensatory 
cell proliferation.

(Ref. 10, page 40)

    After considering the mode of action issues, the NTP classified 1-

[[Page 72911]]

bromopropane as ``reasonably anticipated to be a human carcinogen.'' 
The EPA believes that this classification is consistent with how the 
data would be evaluated under the EPA's Guidelines for Carcinogen Risk 
Assessment (Ref. 9).
    In the comments the Albemarle Corporation submitted on the HAP 
listing petition, the report by Gradient Corp. included section ``2.3 
Human Relevance of NTP Results.'' In that section, issues regarding the 
cancer data for 1-bromopropane were raised. The commenter stated that 
the petitioners cited NTP results for the mouse and rat bioassays as 
evidence of the potential carcinogenic activity of 1-bromopropane (Ref. 
13). The commenter claims that the petitioner did not consider 
potential uncertainties that the commenter believes are found in the 
underlying mutagenicity, genotoxicity, and carcinogenicity data for 1-
bromopropane. The commenter claimed that this was not consistent with 
the EPA's cancer guidelines, which recommend evaluating the weight of 
evidence prior to determining the carcinogenic potential of a chemical 
substance. The commenter went on to summarize information from studies 
they believe show potential uncertainties that are apparent in the 
toxicological information for 1-bromopropane.
    Since the publication of the NTP bioassay cited by the commenter 
(Ref. 13), the NTP published its 13th RoC (Ref. 2). In this report, the 
NTP concluded that there is sufficient evidence of carcinogenicity for 
1-bromopropane based on (1) skin tumors in male rats, (2) tumors of the 
large intestine in female and male rats, and (3) lung tumors in female 
mice. The report also cited malignant mesothelioma of the abdominal 
cavity and pancreatic islet tumors in male rats and skin tumors 
(squamous-cell papilloma, keratoacanthoma, and basal-cell adenoma or 
carcinoma) in female rats as supporting evidence. The NTP's monograph 
for 1-bromopropane addresses all of the data issues that the commenter 
raised (Ref. 10).
    According to the EPA's Guidelines for Carcinogen Risk Assessment 
(Ref. 9), an agent can be classified as ``Likely to Be Carcinogenic to 
Humans'' if it ``has tested positive in animal experiments in more than 
one species, sex, strain, site, or exposure route, with or without 
evidence of carcinogenicity in humans.'' Inconsistencies between how 
the data were interpreted by the NTP and how that same data might be 
interpreted under the EPA's Guidelines for Carcinogen Risk Assessment 
(Ref. 9) were not identified (see reference 6 in the proposed rule). 
The EPA Guidelines for Carcinogen Risk Assessment reference the NTP 
criteria for assessing individual studies in the assessment of 
carcinogenicity, stating ``(c)riteria for the technical adequacy of 
animal carcinogenicity studies have been published and should be used 
as guidance to judge the acceptability of individual studies, e.g., 
NTP, 1984 . . .'' (pages 2-16).
    While the EPA acknowledges that uncertainties exist when evaluating 
any agent, the EPA agrees with NTP's assessment of the data and 
conclusions regarding the carcinogenicity of 1-bromopropane. Indeed, 
according to the EPA's Guidelines for Carcinogen Risk Assessment (Ref. 
9) ``The default option is that positive effects in animal cancer 
studies indicate that the agent under study can have carcinogenic 
potential in humans. Thus, if no adequate human or mode of action data 
are present, positive effects in animal cancer studies are a basis for 
assessing the carcinogenic hazard to humans.'' The EPA believes that 
the evaluation of the available data are consistent with the EPA's 
guidelines including the EPA's ``Supplemental guidance for assessing 
susceptibility from early-life exposure to carcinogens (Final)'' (Ref. 
14).
    The NTP in its monograph of 1-bromopropane (Ref. 10), which 
supported the 13th RoC listing (Ref. 2), concluded the following:

    Studies in vivo show that 1-bromopropane can covalently bind to 
protein in exposed rats and occupationally exposed workers. The 
available data provide some support that 1-bromopropane is genotoxic 
as it induced mutations in bacterial and mammalian cells and DNA 
damage in human cells. There is limited evidence that DNA damage was 
induced in leukocytes from 1-bromopropane-exposed workers. 1-
Bromopropane did not induce chromosomal damage in exposed rodents 
(micronucleus induction assay) or gene-cell mutations (dominant 
lethal mutation assay). Several known or postulated metabolites of 
1-bromopropane have been identified as mutagens and two, glycidol 
and propylene oxide (proposed), were shown to cause chromosomal and 
DNA damage in cultured mammalian cells. Both metabolites caused 
chromosomal damage in cells from rodents exposed in vivo, and 
propylene oxide induced DNA damage in cells from exposed workers. 
Three other 1-bromopropane metabolites ([alpha]-bromohydrin, 3-
bromo-1-propanol, and 1-bromo-2-propanol) were mutagenic or caused 
DNA damage in bacteria.

    The EPA agrees with the NTP's conclusions regarding the 
mutagenicity of 1-bromopropane and its metabolites. With the exception 
of the summary information provided by the commenter for one 
unpublished study, all of the studies cited by the commenter in their 
assessment of the mutagenicity data for 1-bromopropane were cited by 
the NTP in their monograph for 1-bromopropane (Ref. 10). Also, the 
commenter focused on the mutagenicity data for 1-bromopropane, but the 
data on the mutagenicity of the metabolites of 1-bromopropane are an 
important part of the assessment as well. The summarized results of the 
unpublished study provided by the commenter do not change the 
conclusion regarding the mutagenicity of 1-bromopropane and its 
metabolites.

V. Summary of Final Rule

    The EPA is finalizing the addition of 1-bromopropane to the EPCRA 
section 313 list of toxic chemicals. The EPA has determined that 1-
bromopropane meets the listing criteria under EPCRA section 
313(d)(2)(B) based on the available carcinogenicity data.

VI. References

    The 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 the 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 the 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 the 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. USEPA, OEI, 2014. 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.
2. 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. (https://ntp.niehs.nih.gov/pubhealth/roc/roc13/).
3. Anonymous public comment. April 15, 2015. EPA-HQ-TRI-2015-0011-
0048.

[[Page 72912]]

4. Anonymous public comment. April 16, 2015. EPA-HQ-TRI-2015-0011-
0049.
5. Comment submitted by Faye Graul, Executive Director, Halogenated 
Solvents Industry Alliance Incorporated (HSIA). Re: Docket ID No. 
EPA-HQ-TRI-2015-0011. June 15, 2015. EPA-HQ-TRI-2015-0011-0051.
6. Comment submitted by Niomi Krzystowczyk, Vice President, Health, 
Safety and Environment, Albemarle Corporation. Re: Proposed Rule: 
Addition of 1-Bromopropane; Community Right-to-Know Toxic Chemical 
Release Reporting; Docket ID No. EPA-HQ-TRI-2015-0011 [FRL-9925-29-
OEI, 80 FR 20189 (April 15, 2015). June 10, 2015. EPA-HQ-TRI-2015-
0011-0050.
7. USEPA, OEI, 2015. Response to Comments Received on the April 15, 
2015, Federal Register Proposed Rule (80 FR 20189): Addition of 1-
Bromopropane; Community Right-to-Know Toxic Chemical Release 
Reporting. U.S. Environmental Protection Agency Office of 
Environmental Information, Office of Information Analysis and 
Access. August 20, 2015.
8. USEPA, OEI, 2015. Economic Analysis of the Proposed Rule to add 
1-Bromopropane to the EPCRA Section 313 List of Toxic Chemicals. 
February 17, 2015.
9. USEPA, 2005. Guidelines for Carcinogen Risk Assessment. Risk 
Assessment Forum, U.S. Environmental Protection Agency, Washington, 
DC, March 2005. EPA/630/P-03/001F.
10. 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.
11. 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.
12. USEPA, 2014. Summary Report of the State-of-the-Science Workshop 
on Chemically-induced Mouse Lung Tumors: Applications to Human 
Health Assessments. National Center for Environmental Assessment, 
Washington, DC, December 2014. EPA/600/R-14/002.
13. NTP, 2011. Technical Report on the Toxicology and Carcinogenesis 
Studies of 1-Bromopropane (CAS No. 106-94-5) in F344/N Rats and 
B6C3F1 Mice (Inhalation Studies). Toxicity Report Series No. 564. 
NIH Publication No. 11-5906. Department of Health and Human 
Services, Public Health Service, Research Triangle Park, NC.
14. USEPA, 2005. Supplemental guidance for assessing susceptibility 
from early-life exposure to carcinogens (Final). Risk Assessment 
Forum, Washington, DC, March 2005. EPA/630/R-03/003F.

VII. What are the statutory and Executive Order reviews associated with 
this action?

    Additional information about these statutes and Executive Orders 
can be found at https://www2.epa.gov/laws-regulations/laws-and-executive-orders.

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, the 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 the 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 
small entities subject to the requirements of this action are small 
manufacturing facilities. The Agency has determined that of the 140 
entities estimated to be impacted by this action, 136 are small 
businesses; no small 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 the 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. 1531-1538, 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. The 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

[[Page 72913]]

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, the 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, low-income populations, and children.

K. Congressional Review Act (CRA)

    This action is subject to the CRA, and the EPA will submit a rule 
report to each House of the Congress and to the Comptroller General of 
the United States. This action is not a ``major rule'' as defined by 5 
U.S.C. 804(2).

List of Subjects in 40 CFR Part 372

    Environmental protection, Community right-to-know, Reporting and 
recordkeeping requirements, and Toxic chemicals.

    Dated: November 9, 2015.
Gina McCarthy,
Administrator.

    For the reasons set forth in the preamble, the EPA amends 40 CFR 
part 372 as follows:

PART 372--TOXIC CHEMICAL RELEASE REPORTING: COMMUNITY RIGHT-TO-KNOW

0
1. The authority citation for part 372 continues to read as follows:

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


0
2. In Sec.  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:


Sec.  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. 2015-29799 Filed 11-20-15; 8:45 am]
BILLING CODE 6560-50-P
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