Federal Register Vol. 80, No.108,

In December 2014, the existing intermediaries under the pilot were informed that the pilot would end with the effective date of the final rule to create a certified loan application packaging process. While this expiration provision for the pilot was known, the actual date came sooner than expected. To allow the existing intermediaries under the pilot sufficient time to process loan application packages in their queue and to prepare for the implementation of the final rule, the effective date for the final rule will be deferred to October 1, 2015.

This amendment to part 95 of the Federal Aviation Regulations (14 CFR part 95) amends, suspends, or revokes IFR altitudes governing the operation of all aircraft in flight over a specified route or any portion of that route, as well as the changeover points (COPs) for Federal airways, jet routes, or direct routes as prescribed in part 95.

The specified IFR altitudes, when used in conjunction with the prescribed changeover points for those routes, ensure navigation aid coverage that is adequate for safe flight operations and free of frequency interference. The reasons and circumstances that create the need for this amendment involve matters of flight safety and operational efficiency in the National Airspace System, are related to published aeronautical charts that are essential to the user, and provide for the safe and efficient use of the navigable airspace. In addition, those various reasons or circumstances require making this amendment effective before the next scheduled charting and publication date of the flight information to assure its timely availability to the user. The effective date of this amendment reflects those considerations. In view of the close and immediate relationship between these regulatory changes and safety in air commerce, I find that notice and public procedure before adopting this amendment are impracticable and contrary to the public interest and that good cause exists for making the amendment effective in less than 30 days.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, pursuant to the authority delegated to me by the Administrator, part 95 of the Federal Aviation Regulations (14 CFR part 95) is amended as follows effective at 0901 UTC, June 25, 2015.

On August 9, 2007, we issued an interim final rule permitting some attorney advisors to conduct certain prehearing procedures and issue decisions that are fully favorable when the documentary record warrants. 72 FR 44763. We instituted this practice to provide more timely service to the increasing number of applicants for Social Security disability benefits and Supplemental Security Income payments based on disability. We considered the public comments we received on the interim final rule and, on March 3, 2008, we issued a final rule without changes. 73 FR 11349. Under this rule, some attorney advisors may develop claims and, in appropriate cases, issue fully favorable decisions before a hearing.

We originally intended the attorney advisor program to be a temporary modification to our procedures. Therefore, we included in sections 404.942(g) and 416.1442(g) of the interim final rule a provision that the program would end on August 10, 2009, unless we decided to either terminate the rule earlier or extend it beyond that date by publication of a final rule in the Federal Register. Since that time, we have periodically extended the sunset date; as we noted above, the current sunset date for the program is August 7, 2015. 78 FR 45460.

When we published the final rules reinstating the attorney advisor program in 2008, we discussed a variety of concerns about the program and we stated our intent to closely monitor it and to make changes to the program if it did not meet our expectations. 73 FR 11349, 11350, 11351, and 11352.

We explained in the final rule in 2008 that the number of requests for hearings has increased significantly in recent years. We anticipate that we will continue to receive a high number of requests for hearings. The attorney advisor program has assisted our efforts to reduce the backlog of pending hearing requests, and we believe that the program should continue at this time.

In order to preserve the maximum degree of flexibility we need to effectively manage our hearings-level workloads, we have decided to extend the attorney advisor rule for another 2 years, until August 4, 2017. As before, we reserve the authority to end the program earlier or to extend it by publishing a final rule in the Federal Register.

We follow the Administrative Procedure Act (APA) rulemaking procedures specified in 5 U.S.C. 553 when developing regulations. Section 702(a)(5) of the Social Security Act, 42 U.S.C. 902(a)(5). The APA provides exceptions to its notice and public comment procedures when an agency finds there is good cause for dispensing with such procedures because they are impracticable, unnecessary, or contrary to the public interest. We have determined that good cause exists for dispensing with the notice and public comment procedures for this rule. 5 U.S.C. 553(b)(B). Good cause exists because this final rule only extends the sunset date of an existing rule. It makes no substantive changes to the rule. The current regulations expressly provide that we may extend or terminate this rule. Therefore, we have determined that opportunity for prior comment is unnecessary, and we are issuing this rule as a final rule.

In addition, because we are not making any substantive changes to the existing rule, we find that there is good cause for dispensing with the 30-day delay in the effective date of a substantive rule provided by 5 U.S.C. 553(d)(3). To ensure that we have uninterrupted authority to use attorney advisors to reduce the number of pending cases at the hearing level, we find that it is in the public interest to make this final rule effective on the date of publication.

We consulted with the Office of Management and Budget (OMB) and determined that this final rule does not meet the criteria for a significant regulatory action under Executive Order 12866, as supplemented by Executive Order 13563.

We certify that this final rule will not have a significant economic impact on a substantial number of small entities because it affects individuals only. Therefore, the Regulatory Flexibility Act, as amended, does not require us to prepare a regulatory flexibility analysis.

This final rule does not create any new or affect any existing collections and, therefore, does not require OMB approval under the Paperwork Reduction Act.

For the reasons stated in the preamble, we amend subpart J of part 404 and subpart N of part 416 of Chapter III of title 20 of the Code of Federal Regulations as set forth below:

The Indian Gaming Regulatory Act (IGRA or the Act), Public Law 100-497, 25 U.S.C. 2701 et seq., was signed into law on October 17, 1988. The Act established the Commission and set out a comprehensive framework for the regulation of gaming on Indian lands. The purposes of the Act include: Providing a statutory basis for the operation of gaming by Indian tribes as a means of promoting tribal economic development, self-sufficiency, and strong tribal governments; ensuring that the Indian tribe is the primary beneficiary of the gaming operation; and declaring that the establishment of independent federal regulatory authority for gaming on Indian lands, the establishment of federal standards for gaming on Indian lands, and the establishment of a National Indian Gaming Commission are necessary to meet congressional concerns regarding gaming and to protect such gaming as a means of generating tribal revenue. 25 U.S.C. 2702.

On August 9, 2012, the Commission published a final rule amending 25 CFR part 573 (Compliance and Enforcement) to include a graduated pre-enforcement process through which a tribe may come into voluntary compliance. 77 FR 47517, Aug. 9, 2012. This document updates references in 25 CFR part 514 that are no longer accurate due to those amendments.

On September 25, 2012, the Commission published a final rule consolidating all appeal proceedings before the Commission into a (then) new subchapter H (Appeal Proceedings Before the Commission), thereby removing former parts 524, 539, and 577. 77 FR 58941, Sept. 25, 2012. This document updates 25 CFR parts 513, 514, 522, 533, 535, 571, 573, and 575 to remove references to those parts no longer in existence.

On January 25, 2013, the Commission published a final rule amending 25 CFR parts 556 and 558 (Background investigations and Gaming Licenses for Key Employees and Primary Management Officials) to streamline certain submissions to the Commission and to ensure that certain tribal notifications comply with the Act. 78 FR 5276, Jan 25. 2013. This document updates 25 CFR part 573 to reflect the amendments to those parts.

In June of 2014, the Commission relocated its headquarters. This document updates the mailing address contained within 25 CFR parts 514 and 516. The Commission also identified minor grammatical errors in certain other regulations and now corrects those errors.

This document revises the definition of “Chairman” in 25 CFR 502.1 to include the word “Chair.” This reflects the gender-neutral term that occurs elsewhere in the Commission's regulations. No substantive change is intended with this correction.

This document revises 25 CFR 513.4(b) and 513.32(a) to remove references to the appeal procedures formerly found at 25 CFR part 577 (which no longer exists). It now references the appeal procedure at 25 CFR parts 580-585. This document also corrects a grammatical error in § 513.32(a): In the third sentence, the first “matters” is corrected to the singular “matter,” while the second “matters” remains plural.

This document revises 25 CFR 514.8 and 514.17(c) to reflect the Commission's new mailing address. This document also amends 25 CFR 514.10 to revise paragraphs (a) and (b) to correct a reference from “25 CFR 573.6(a)(2)” to “25 CFR 573.4(a)(2).”

The document revises 25 CFR 516.4(b) to reflect the Commission's new mailing address.

This document revises 25 CFR 522.5 and 522.7(a), (b) to remove references to 25 CFR part 524 (which no longer exists) and replaces them with references to 25 CFR part 582. This document also revises 25 CFR 522.10(c) and (f) to make minor grammatical changes. In paragraph (c), “Tribe” is changed to “tribe”; in paragraph (f), a comma is placed after “limits.”

This document amends 25 CFR 531.1 to revise paragraphs (b)(4), (b)(6), and (b)(16) by making minor grammatical changes and by clarifying certain requirements. In paragraph (b)(4), a comma is placed after “training”; in paragraph (b)(6), the word “gaming” is added before “operation's”; and in paragraph (b)(16), the phrase “National Indian Gaming Commission” is replaced with the word “Commission.” No substantive change is intended by these corrections.

This document revises 25 CFR 533.2 to remove a reference to 25 CFR part 539 (which no longer exists) and replaces it with a reference to 25 CFR part 583. The document also amends 25 CFR 533.3, revising paragraphs (a)(1) and (a)(2) to make minor grammatical changes. In paragraph (a)(1), the word “and” is added to the end of the sentence; and in paragraph (a)(2), the word “and” is removed and replaced with a period. The document also revises 25 CFR 533.6(b)(3) to make a minor grammatical change, replacing “this” with “the.”

This document revises 25 CFR 535.1(d)(2) to make a minor grammatical change. In paragraph (d)(2), a semicolon at the end of the paragraph is replaced with a period. This document also revises 25 CFR 535.1(d)(3) by removing references to “part 539” (which no longer exists) and replacing it with references to “part 583.” This document also revises 25 CFR 535.3 to remove a reference to “part 577” and to replace it with a reference to “parts 584 or 585.” A minor grammatical change is also made to the second sentence of § 535.3, replacing the word “void” with “voiding.” No substantive change is intended by this correction.

This document revises 25 CFR 556.2(a) to make a minor grammatical change by adding a comma after the word “criminal.” This document also revises 25 CFR 556.5(a)(3) by adding a comma after the word “habits.” Finally, this document revises 25 CFR 556.8 by removing the word “the” before “February” and adding a comma after “2013.”

This document revises 25 CFR 559.1(a) by changing “obtain” to “obtains.” This document also revises 25 CFR 559.4 by adding a comma after the word “standards.” Finally, to mirror the language in the regulation, this document revises 25 CFR 559.5 by changing the section title from “Does a tribe need to” to “Must a tribe.”

This document revises the second sentence of 25 CFR 571.3 by replacing the language “under part 577 of this chapter is addressed in § 577.8” with “is addressed in § 584.9.” This change is required because part 577 no longer exists and was replaced by the language found in 25 CFR part 584. The document revises 25 CFR 571.4 by replacing “NIGC” with “the Commission.” This change is intended to create uniformity in the agency's regulations. Additionally, 25 CFR 571.4 is revised to add “or resolution” after the word “ordinance.” Finally, this document revises 25 CFR 571.11 by removing a reference to a nonexistent “part 577” and replacing it with “part 584.”

This document revises 25 CFR 573.1 by making a minor grammatical change. Specifically, “notice” is now changed to “notices.” Section 573.2(a) is revised by removing the word “respondent” from the regulation because the regulation does not involve official agency action, and therefore no “respondent” exists. No substantive change occurs as a result of this revision. In addition, 25 CFR 573.4 is amended to revise paragraphs (a)(1)(ii), (a)(5), (a)(10), and (c)(3). Paragraph (a)(1)(ii) is revised by replacing “provides” with “is served with.” A minor grammatical change is made to paragraph (a)(5), removing the phrase “having been,” as this change helps make the regulation easier to read. A minor grammatical change is also made to paragraph (a)(10), replacing “Indian Gaming Regulatory Act” with “the Act.” Paragraph (a)(10) is also revised to replace references to “§ 558.2” with “§ 556.5,” and “§ 558.5” with “§ 558.4.” Finally, paragraph (c)(3) is revised to replace a reference to “subchapter H,” with a reference to “parts 584 or 585” for clarity.

This document amends 25 CFR 575.6 to revise paragraphs (a)(1) and (b) to replace references to “part 577” (which no longer exists) with references to “parts 584 or 585.” This document also revises 25 CFR 575.9 to replace references to “part 577” (which no longer exists) with references to “parts 584 or 585.” Section 575.9 is also revised by renumbering it to “575.7” due to a previous numbering error in the regulations.

This document revises 25 CFR 580.6 by making a minor grammatical change, replacing “in” with “from.” This document also revises 25 CFR 580.12 by replacing “NIGC” with “Commission” to create uniformity in the agency's regulations.

Under the Administrative Procedure Act, a notice of proposed rulemaking is not required when an agency, for good cause, finds that notice and public comments are impractical, unnecessary, or contrary to the public interest. Because the revisions here are technical in nature and intended solely to update the Commission's current mailing address, to correct outdated references, and to correct minor grammatical errors, the Commission is publishing a technical amendment.

This rule will not have a significant economic effect on a substantial number of small entities as defined by the Regulatory Flexibility Act, 5 U.S.C. 601, et seq. Indian tribes are not considered to be small entities for purposes of the Regulatory Flexibility Act.

This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule does not have an annual effect on the economy of $100 million or more. This rule will not cause a major increase in costs or prices for consumers, individual industries, federal, state, or local government agencies or geographic regions, and does not have a significant adverse effect on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises.

The Commission, as an independent regulatory agency, is exempt from compliance with the Unfunded Mandates Reform Act, 2 U.S.C. 1502(1); 2 U.S.C. 658(1).

In accordance with Executive Order 12630, the Commission determined this proposed rule does not have significant takings implications. A takings implication assessment is not required.

In accordance with Executive Order 12988, the Commission determined that the rule does not unduly burden the judicial system and meets the requirements of sections 3(a) and 3(b)(2) of the Executive Order.

The Commission has determined that this rule does not constitute a major federal action significantly affecting the quality of the human environment and that a detailed statement is not required pursuant to the National Environmental Policy Act of 1969, 42 U.S.C. 4321, et seq.

The information collection requirements contained in these rules were previously approved by the Office of Management and Budget as required by the Paperwork Reduction Act, 44 U.S.C. 3501, et seq., and assigned the following OMB control numbers with the applicable expiration dates: (i) 3141-0001, expires on October 31, 2016; (ii) 3141-0003, expires on October 31, 2016; (iii) 3141-0004, expires on October 31, 2015; (iv) 3141-0007, expires on November 30, 2015; and (v) 3141-0012, expires on October 31, 2015.

For the reasons set forth in the Preamble, the Commission revises 25 CFR parts 502, 513, 514, 516, 522, 531, 533, 535, 556, 559, 571, 573, 575, and 580 as follows:

Background

The temporary regulations that are the subject of these amendments are under section 6045A of the Internal Revenue Code. The temporary regulations (TD 9713) were published in the Federal Register on Friday, March 13, 2015 (80 FR 13233).

Under § 1.6045A-1, a broker is required to provide certain information relating to a transfer of a debt instrument that is a covered security on a transfer statement. Section 1.6045A-1T(f) requires a broker to provide certain additional information on the transfer statement. Section 1.6045A-1T(f) applies to a transfer that occurs on or after June 30, 2015. After the publication of the temporary regulations, the Treasury Department and the IRS received comments requesting that the applicability date of the regulations be delayed until January 1, 2016. In response to these comments, this document amends the applicability date to make the regulations apply to transfers that occur on or after January 1, 2016.

Accordingly, 26 CFR part 1 is corrected by making the following correcting amendments:

Section 382 of the Code provides that the taxable income of a loss corporation for a year following an ownership change may be offset by pre-change losses only to the extent of the section 382 limitation for such year. An ownership change occurs with respect to a corporation if it is a loss corporation on a testing date and, immediately after the close of the testing date, the percentage of stock of the corporation owned by one or more 5-percent shareholders has increased by more than 50 percentage points over the lowest percentage of stock of such corporation owned by such shareholders at any time during the testing period. A testing date is any date on which occurs any change in the ownership of loss corporation stock that affects the percentage of stock owned by any 5-percent shareholder (owner shift).

Pursuant to section 382(g)(4)(A), shareholders who own less than five percent of a loss corporation are aggregated and treated as a single 5-percent shareholder (a public group). In addition, new public groups may be created as a result of certain transactions under the segregation rules in the section 382 regulations. Any new public group is tracked separately from, and in addition to, the public group or groups that existed previously and is treated as a new 5-percent shareholder that increases its ownership interest in the loss corporation.

One particular segregation rule, which was imposed by § 1.382-2T(j)(3)(i) of the Temporary Income Tax Regulations until it was superseded, required segregation when an individual or entity that owned five percent or more of the loss corporation transferred an interest in the loss corporation to public shareholders. After the sale, stock owned by a public group that existed immediately before the sale was treated separately from the stock owned by the public group that acquired stock from the seller. This separate public group was treated as a new 5-percent shareholder. However, this rule was rendered inoperative by § 1.382-3(j)(13), part of a set of regulations published in TD 9638 [78 FR 62418] on October 22, 2013. Under the new regulation, no new public group is created on the transfer of stock to the public shareholders; instead, the transferred stock is treated as acquired proportionately by the public groups existing at the time of the transfer.

Notice 2010-2 (2010-2 IRB 251 (December 16, 2009)) (see § 601.601(d)(2)(ii)(b) of this chapter) provides guidance regarding the application of section 382 and other provisions of law to corporations whose instruments are acquired and disposed of by the Treasury pursuant to EESA. Notice 2010-2 relates to instruments acquired by Treasury pursuant to the following EESA programs: (i) The Capital Purchase Program for publicly-traded issuers; (ii) the Capital Purchase Program for private issuers; (iii) the Capital Purchase Program for S corporations; (iv) the Targeted Investment Program; (v) the Asset Guarantee Program; (vi) the Systemically Significant Failing Institutions Program; (vii) the Automotive Industry Financing Program; and (viii) the Capital Assistance Program for publicly-traded issuers. (These programs are collectively referred to as “Programs” in that Notice and in this preamble.)

Under Section III(G) of Notice 2010-2, a “Covered Instrument” is an instrument that is acquired by Treasury in exchange for an instrument that was issued to Treasury under the Programs, or is acquired by Treasury in exchange for another Covered Instrument. For most purposes of that Notice, a Covered Instrument is treated as though it had been issued directly to Treasury under the Programs.

Section III(E) of Notice 2010-2 provides the following rule to govern the sale by Treasury of stock of a corporation to public shareholders:

The Treasury Department and the IRS became concerned that the elimination of the segregation rule described earlier in this preamble may have unintentionally rendered inoperative the rule in Notice 2010-2 that protects a loss corporation from an owner shift when Treasury sells stock that it held pursuant to the Programs to public shareholders.

On July 31, 2014, the Treasury Department and the IRS published final and temporary regulations (TD 9685) in the Federal Register (79 FR 44280). The temporary regulations modified the effective/applicability date rule of TD 9638 to except from the changes to the segregation rules in those regulations the sale by the Treasury Department to public shareholders of any “Program Instrument” (an instrument issued pursuant to a Program or a Covered Instrument). As a result, under the temporary regulations, a sale of stock by Treasury to the public creates a public group, and the rule of Section III(E) of Notice 2010-2 continues to apply as intended. This provision only affects the sale of a Program Instrument by the Treasury Department and does not affect the application of the segregation rule changes in TD 9638 to any other transactions involving stock of the corporations that participated in the Programs.

A notice of proposed rulemaking (REG-105067-14) cross-referencing the temporary regulations and incorporating the text of the temporary regulations was also published in the Federal Register (79 FR 44324) on July 31, 2014. No written comments were received in response to the notice of proposed rulemaking. No requests for a public hearing were received, and accordingly no hearing was held.

This Treasury Decision adopts the text of the temporary and proposed regulations without substantive change. As a result, the effective date modification provided in the temporary regulations is now a part of the permanent section 382 regulations, and the temporary regulations are removed.

It has been determined that this final regulation is not a significant regulatory action as defined in Executive Order 12866, as supplemented by Executive Order 13563. Therefore, a regulatory assessment is not required. It is hereby certified that these regulations will not have a significant economic impact on a substantial number of small entities. This certification is based on the fact that, if the regulations apply to any small entities, the effect will not be to increase their tax liability, but to prevent a potential increase in tax liability that might otherwise occur. Therefore, a Regulatory Flexibility Analysis under the Regulatory Flexibility Act (5 U.S.C. chapter 6) is not required. Pursuant to section 7805(f) of the Code, the notice of proposed rulemaking preceding these regulations was submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on their impact on small business, and no such comments were received.

The principal author of these regulations is Stephen R. Cleary of the Office of Associate Chief Counsel (Corporate). However, other personnel from the Treasury Department and the IRS participated in their development.

Accordingly, 26 CFR part 1 is amended as follows:

This rule is a matter of internal Department management. It has been drafted and reviewed in accordance with section 1(b) of Executive Order 12866. The Assistant Attorney General for the Civil Division has determined that this rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866 and accordingly this rule has not been reviewed by the Office of Management and Budget. In accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)), the Assistant Attorney General for the Civil Division has reviewed this rule, and by approving it certifies that this rule will not have a significant economic impact on a substantial number of small entities. This rule will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with Executive Order 13132, it is determined that this rule does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment.

Accordingly, for the reasons stated in the preamble, title 28, chapter I, part 0, of the Code of Federal Regulations is amended as set forth below:

In this document, the Bureau finalizes its regulation on searches of inmates using x-ray devices and technology (28 CFR part 552, subpart B). We change this regulation to clarify that body imaging search devices are “electronic search devices” for routine or random use in searching inmates, and are distinguished from medical x-ray devices, the use of which require the inmate's consent, or Regional Director approval, for use as search devices. We published a proposed rule on this subject on February 14, 2014 (79 FR 8910). We received a total of twenty comments on the proposed rule. Three comments were generally in favor of the proposed changes. Eleven comments were copies of the same form letter. We respond below to the issues raised by that form letter and the remaining six comments.

Fifteen comments (including the eleven form letters) were concerned that the electronic devices used by the Bureau, particularly those which use x-ray technology, will be harmful to inmates. Another commenter stated that the use of x-ray technology as intended by the Bureau is so unsafe that it “is a clear violation of human rights.”

The x-ray technology used for searches by the Bureau employs a very low level of radiation. Radiation is measured in units called “sieverts.” A person scanned by a Bureau body scanner would receive only 0.25 sieverts and can be scanned up to 1,000 times a year. For context, a scan from this machine is equal to eating two and a half bananas (the potassium in bananas emit radiation). Sleeping next to someone exposes you to .05 sieverts, because we all have minerals in our bones that emit radiation. Also, people living in areas of high elevations are exposed to almost 5 times (1.2 sieverts) as much radiation as one scan from a Bureau body scanner, because there is more cosmic radiation at high elevations. An airplane flight from New York to Los Angeles exposes a human body to 40 sieverts of radiation. Again, the Bureau's x-ray technology scanners employ only .25 sieverts, so low a level of radiation as to be safe.

Further, the Bureau requested an independent study (“Radiation Protection Report”) of its pilot program use of the “Radpro SecurPass” technology. The review, conducted in 2012, was generated and peer reviewed by radiological physicists holding Certified Health Physicist credentials and board certification of the American Board of Radiology in Diagnostic Radiology. The Report concluded that the average effective reference dose was 0.233 sieverts, which is representative of the maximum possible radiation dose for the machine to one person for one scan. The Report concluded that the system may be operated at that dose level up to 1,000 times per year while maintaining the recommended safe radiation dose.

The use of electronic search devices described in the proposed rule is also within established inmate search procedures. There is no impact it will have on the federal inmate population which is not already present. The proposed rule clarified that body x-ray imaging search devices are “electronic search devices” for routine or random use in searching inmates. This change does not affect physical contact with inmates or require disrobement. Other than increased effectiveness at identifying contraband through the use of new minimally invasive hand-held technology, there exists no actual or perceivable difference between already-in-use electronic search devices and the proposed x-ray search device. In fact, the use of the technology will cut down the frequency and need for more invasive searches of the type that inmates seek to avoid.

Further, prisoners, visitors, and staff have diminished Fourth Amendment protections in a correctional setting under the constellation of rules created by Bell, Hudson, and Turner. In Bell v. Wolfish, 441 U.S. 520 (1979) and Hudson v. Palmer, 468 U.S. 517 (1984), inmates brought challenges to searches of their person and cells, respectively. The Bell court noted prisons are uniquely dangerous environments, and held that the interest in keeping out contraband outweighed inmate privacy concerns. Similarly, the Hudson court found prison cell searches are categorically reasonable since a prisoner's expectation of privacy must always yield to the paramount interest in institutional security. Turner v. Safley, 482 U.S. 78 (1987) created a new standard: When a prison regulation impinges on the constitutional rights of an inmate, staff member, or visitor, the regulation is valid if it is reasonably related to legitimate penological interests.

The Turner standard, with the fact-specific principles of Bell have been consistently used guidelines to reference for inmate body searches. The Supreme Court specifically invoked both cases as primary guidance in Florence v. Bd. of Chosen Freeholders of County of Burlington. The Court held it was reasonable in a physical search to command “detainees to lift their genitals or cough in a squatting position.” These procedures, similar to the ones upheld in Bell, are designed to uncover contraband that can go undetected by a patdown, metal detector, and other less invasive searches. 132 S. Ct. 1510, 1520, 182 L. Ed. 2d 566 (2012). Physical manipulation of an unclothed area, however, would not be permissible. Id. The non-contact electronic device search is precisely within the “less-invasive,” non-controversial ambit described in Florence.

It is also important to note that the regulations will retain current language stating that use of any electronic device “does not require the inmate to remove clothing.” 28 CFR 552.11.

One commenter was concerned that Bureau staff are not qualified to use new technology. This is not true. Policy accompanying the change to this regulation and the implementation of any new search device under these regulations will require training on the use of the devices. Operators Manuals for the technological devices will be required for all employees who operate the scanners. This training will be re-implemented annually.

One commenter felt that “the cost of instituting [body scanners would be] incredible.” The scanning technology used by the Bureau is also routinely used in other public safety sectors (e.g. airport security, military, state jail security, etc.) and is not prohibitively expensive. The Bureau evaluated and tested several different types of whole body imaging devices, some acquired through surplus acquisition at no cost from other federal agencies. During the evaluation period, a significant amount of dangerous contraband (i.e., weapons, drugs and contraband cell phones), were detected with these devices and confiscated. Because the technology provides enhanced institution security, promotes staff and inmate safety, and ultimately increases the safety of the public, the return on investment for the cost of these devices is significant. In the Bureau's correctional judgment, the loss of life or serious injury, whether staff, inmate or a member of the public, is immeasurable and as such, the use of scanning technology to prevent such occurrences is reasonable and warranted.

For the aforementioned reasons, we now finalize the proposed rule published on February 14, 2014 (79 FR 8910), without change.

This regulation has been drafted and reviewed in accordance with Executive Order 12866, “Regulatory Planning and Review” section 1(b), Principles of Regulation. The Department of Justice has determined that this rule is a “significant regulatory action” under Executive Order 12866, section 3(f), Regulatory Planning and Review, and accordingly this rule has been reviewed by the Office of Management and Budget (OMB).

This regulation will not have substantial direct effects on the States, on the relationship between the national government and the States, or on distribution of power and responsibilities among the various levels of government. Therefore, in accordance with Executive Order 13132, it is determined that this rule does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment.

The Director of the Bureau of Prisons, in accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)), has reviewed this regulation and by approving it certifies that this regulation will not have a significant economic impact upon a substantial number of small entities for the following reasons: This rule pertains to the correctional management of offenders committed to the custody of the Attorney General or the Director of the Bureau of Prisons, and its economic impact is limited to the Bureau's appropriated funds.

This rule will not result in the expenditure by State, local and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more in any one year, and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

This rule is not a major rule as defined by § 804 of the Small Business Regulatory Enforcement Fairness Act of 1996. This rule will not result in an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets.

Accordingly, under rulemaking authority vested in the Attorney General in 5 U.S.C. 301; 28 U.S.C. 509, 510 and delegated to the Director, Bureau of Prisons in 28 CFR 0.96, we amend 28 CFR part 552 as set forth below.

Pursuant to the authority granted in 33 U.S.C. 1605, the DoN amends 32 CFR part 706.

This amendment provides notice that the DAJAG (Admiralty and Maritime Law), of the DoN, under authority delegated by the Secretary of the Navy, has certified that USS DETROIT (LCS 7) is a vessel of the Navy which, due to its special construction and purpose, cannot fully comply with the following specific provisions of 72 COLREGS without interfering with its special function as a naval ship: Annex I paragraph 2(a)(i), pertaining to the location of the forward masthead light at a height not less than 12 meters above the hull; Annex I, paragraph 3(a), pertaining to the location of the forward masthead light in the forward quarter of the ship, and the horizontal distance between the forward and after masthead lights. The DAJAG (Admiralty and Maritime Law) has also certified that the lights involved are located in closest possible compliance with the applicable 72 COLREGS requirements.

Moreover, it has been determined, in accordance with 32 CFR parts 296 and 701, that publication of this amendment for public comment prior to adoption is impracticable, unnecessary, and contrary to public interest since it is based on technical findings that the placement of lights on this vessel in a manner differently from that prescribed herein will adversely affect the vessel's ability to perform its military functions.

For the reasons set forth in the preamble, the DoN amends part 706 of title 32 of the Code of Federal Regulations as follows:

You may be potentially affected by this action if you manufacture, process, or use the chemical substances contained in this rule. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Manufacturers or processors of one or more subject chemical substances (NAICS codes 325 and 324110), e.g., chemical manufacturing and petroleum refineries.

This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA. Chemical importers are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements promulgated at 19 CFR 12.118 through 12.127 and 19 CFR 127.28. Chemical importers must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA. Importers of chemicals subject to these SNURs must certify their compliance with the SNUR requirements. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, any persons who export or intend to export a chemical substance that is the subject of a proposed or final rule are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see § 721.20), and must comply with the export notification requirements in 40 CFR part 707, subpart D.

1. Submitting CBI. Do not submit this information to EPA through regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

2. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

EPA is promulgating these SNURs using direct final procedures. These SNURs will require persons to notify EPA at least 90 days before commencing the manufacture or processing of a chemical substance for any activity designated by these SNURs as a significant new use. Receipt of such notices allows EPA to assess risks that may be presented by the intended uses and, if appropriate, to regulate the proposed use before it occurs. Additional rationale and background to these rules are more fully set out in the preamble to EPA's first direct final SNUR published in the Federal Register issue of April 24, 1990 (55 FR 17376) (FRL-3658-5). Consult that preamble for further information on the objectives, rationale, and procedures for SNURs and on the basis for significant new use designations, including provisions for developing test data.

Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a “significant new use.” EPA must make this determination by rule after considering all relevant factors, including the four bulleted TSCA section 5(a)(2) factors listed in Unit III. Once EPA determines that a use of a chemical substance is a significant new use, TSCA section 5(a)(1)(B) requires persons to submit a significant new use notice (SNUN) to EPA at least 90 days before they manufacture or process the chemical substance for that use. Persons who must report are described in § 721.5.

General provisions for SNURs appear in 40 CFR part 721, subpart A. These provisions describe persons subject to the rule, recordkeeping requirements, exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the rule. Provisions relating to user fees appear at 40 CFR part 700. According to § 721.1(c), persons subject to these SNURs must comply with the same SNUN requirements and EPA regulatory procedures as submitters of PMNs under TSCA section 5(a)(1)(A). In particular, these requirements include the information submission requirements of TSCA section 5(b) and 5(d)(1), the exemptions authorized by TSCA section 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA may take regulatory action under TSCA section 5(e), 5(f), 6, or 7 to control the activities for which it has received the SNUN. If EPA does not take action, EPA is required under TSCA section 5(g) to explain in the Federal Register its reasons for not taking action.

Section 5(a)(2) of TSCA states that EPA's determination that a use of a chemical substance is a significant new use must be made after consideration of all relevant factors, including:

• The projected volume of manufacturing and processing of a chemical substance.

• The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance.

• The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance.

• The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.

In addition to these factors enumerated in TSCA section 5(a)(2), the statute authorized EPA to consider any other relevant factors.

To determine what would constitute a significant new use for the 22 chemical substances that are the subject of these SNURs, EPA considered relevant information about the toxicity of the chemical substances, likely human exposures and environmental releases associated with possible uses, and the four bulleted TSCA section 5(a)(2) factors listed in this unit.

EPA is establishing significant new use and recordkeeping requirements for 22 chemical substances in 40 CFR part 721, subpart E. In this unit, EPA provides the following information for each chemical substance:

• PMN number.

• Chemical name (generic name, if the specific name is claimed as CBI).

• Chemical Abstracts Service (CAS) Registry number (assigned for non-confidential chemical identities).

• Basis for the TSCA section 5(e) consent order or, the basis for the TSCA non-section 5(e) SNURs (i.e., SNURs without TSCA section 5(e) consent orders).

• Tests recommended by EPA to provide sufficient information to evaluate the chemical substance (see Unit VIII. for more information).

• CFR citation assigned in the regulatory text section of this rule.

The regulatory text section of this rule specifies the activities designated as significant new uses. Certain new uses, including production volume limits (i.e., limits on manufacture volume) and other uses designated in this rule, may be claimed as CBI. Unit IX. discusses a procedure companies may use to ascertain whether a proposed use constitutes a significant new use.

This rule includes 2 PMN substances (P-13-930 and P-14-763) that are subject to “risk-based” consent orders under TSCA section 5(e)(1)(A)(ii)(I) where EPA determined that activities associated with the PMN substances may present unreasonable risk to human health or the environment. Those consent orders require protective measures to limit exposures or otherwise mitigate the potential unreasonable risk. The so-called “TSCA section 5(e) SNURs” on these PMN substances are promulgated pursuant to § 721.160, and are based on and consistent with the provisions in the underlying consent orders. The TSCA section 5(e) SNURs designate as a “significant new use” the absence of the protective measures required in the corresponding consent orders.

This rule also includes SNURs on 20 PMN substances that are not subject to consent orders under TSCA section 5(e). In these cases, for a variety of reasons, EPA did not find that the use scenario described in the PMN triggered the determinations set forth under TSCA section 5(e). However, EPA does believe that certain changes from the use scenario described in the PMN could result in increased exposures, thereby constituting a “significant new use.” These so-called “TSCA non-section 5(e) SNURs” are promulgated pursuant to § 721.170. EPA has determined that every activity designated as a “significant new use” in all TSCA non-section 5(e) SNURs issued under § 721.170 satisfies the two requirements stipulated in § 721.170(c)(2), i.e., these significant new use activities are different from those described in the premanufacture notice for the substance, including any amendments, deletions, and additions of activities to the premanufacture notice, and may be accompanied by changes in exposure or release levels that are significant in relation to the health or environmental concerns identified” for the PMN substance.

Chemical name: 2-Butene, 1,1,1,4,4,4-hexafluoro-, (2Z)-.

CAS number: 692-49-9.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a heat transfer fluid. Based on test data on the PMN substance as well as structure activity relationship (SAR) analysis of analogous small fluorinated compounds, EPA identified concerns for cardiac sensitization, developmental toxicity, neurotoxicity, reproductive toxicity and oncogenicity from inhalation exposures to the PMN substance. As described in the PMN, occupational exposures are expected to be minimal due to no domestic manufacture and consumer exposure is not expected due to no use of the substance in a consumer product. Therefore, EPA has not determined that the proposed processing or use of the substance may present an unreasonable risk. EPA has determined, however, that any domestic manufacture, any use other than as described in the PMN, or any use of the substance in a consumer product may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(i) and (b)(3)(ii).

Recommended testing: EPA has determined that inhalation monitoring data, collected according to the EPA draft Inhalation Monitoring Data Collection Guidelines (located in the docket under docket ID number EPA-HQ-OPPT-2015-0220) would help characterize the human health effects of the PMN substance.

CFR citation: 40 CFR 721.10830.

Chemical name: Aluminum phosphate (generic).

CAS number: Claimed confidential.

Basis for action: The PMN states that the substance will be used as a flame retardant for industrial plastics. Based on SAR analysis of test data on analogous respirable, poorly soluble particulates, EPA identified concerns for lung effects, blood toxicity, hypersensitivity, developmental neurotoxicity, and immunotoxicity from inhalation exposures to the PMN substance. Further, based on ecological SAR analysis of test data on analogous aluminum salts, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 87 parts per billion (ppb) of the PMN substance in surface waters. As described in the PMN, occupational exposures are expected to be minimal due to use of respiratory protection, and releases of the substance are not expected to result in surface water concentrations that exceed 87 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the PMN substance without the use of National Institute of Occupational Safety and Health (NIOSH)-certified respirator with an assigned protection factor (APF) of at least 10, where inhalation exposures are expected, or any use of the substance resulting in surface water concentrations exceeding 87 ppb may cause serious human health effects and significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at 40 CFR 721.170(b)(3)(ii) and (b)(4)(ii).

Recommended testing: EPA has determined that the results of a 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465 or Organisation for Economic Co-operation and Development (OECD) Test Guideline 413); a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and an algal toxicity test (Office of Chemical Safety and Pollution Prevention (OCSPP) Test Guideline 850.4500) would help characterize the human health and environmental effects of the PMN substance. EPA also recommends that the guidance document on aquatic toxicity testing of difficult substance and mixtures (OECD Test Guideline 23) be consulted to facilitate solubility of the PMN substance in the test media.

CFR citation: 40 CFR 721.10831.

Chemical name: Alkyl triazine (generic).

CAS number: Claimed confidential.

Basis for action: The PMN states that the substance will be used in the removal of hydrogen sulfide. Based on test data on the PMN substance, as well as ecological SAR analysis of test data on analogous aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 130 ppb of the PMN substance in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations that exceed 130 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 130 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(i) and (b)(4)(ii).

Recommended testing: EPA has determined that the results of a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400) and a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10832.

Chemical name: Substituted bis 2,6-xylenol (generic).

CAS number: Claimed confidential.

Effective date of TSCA section 5(e) consent order: December 10, 2014.

Basis for TSCA section 5(e) consent order: The PMN states that the generic (non-confidential) use of the substance will be as a reactant in polymerization reactions. Based on SAR analysis of test data on structurally similar substances, EPA identified concerns for liver, kidney and developmental toxicity; blood effects, sensitization, and endocrine disruption. Further, based on test data on the PMN substance, EPA predicts toxicity to aquatic organisms at concentrations that exceed 6 ppb of the PMN substance in surface waters. The order was issued under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I), based on a finding that the substance may present an unreasonable risk of injury to the environment and human health, and there may be significant (or substantial) human exposure to the substance. To protect against these exposures and risks, the consent order requires:

1. Use of personal protective equipment involving impervious gloves and protective clothing (where there is a potential for dermal exposure) and a NIOSH-certified respirator with an APF of at least 50 (where there is a potential for inhalation exposure).

2. Establishment and use of a hazard communication program, including human health, environmental hazard precautionary statements on each label and the MSDS.

3. Manufacturing, processing, or use of the PMN substance only as an intermediate.

4. Submission of certain toxicity testing prior to exceeding the confidential production volume limits of the PMN substance specified in the consent order.

5. No predictable or purposeful release of the PMN substance from manufacturing, processing or use into the waters of the United States that result in surface water concentrations exceeding 6 ppb.

The SNUR designates as a “significant new use” the absence of these protective measures.

Recommended testing: EPA has determined that the results of certain toxicity testing, identified in the TSCA 5(e) consent order would help characterize possible effects of the substance. The submitter has agreed not to exceed the first confidential volume limit without performing an aromatase (human recombinant) test (OCSPP Test Guideline 890.1200) and a steroidogenesis (human cell line-H295R) test (OCSPP Test Guideline 890.1550 or OECD Test Guideline 456). Further, the Order prohibits the Company from exceeding the second confidential production volume limit unless the Company submits the Tier 2 testing described in the Testing section of this Order in accordance with the conditions specified in the Testing section.

CFR citation: 40 CFR 721.10833.

Chemical name: Heteropolycyclic diacrylate (generic).

CAS number: Claimed confidential.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a coating resin. Based on test data on the PMN, EPA identified concerns for dermal and ocular irritation, and systemic toxicity from the dermal, ocular, and oral routes. Further, based on ecological SAR analysis of test data on analogous acrylates, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 120 ppb of the PMN substance in surface waters. As described in the PMN, occupational exposures are expected to be minimal due to the use of impervious gloves, goggles, and a NIOSH-certified particulate respirator with an APF of at least 10. Further, releases of the substance are not expected to result in surface water concentrations that exceed 120 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance without the use of impervious gloves and goggles, when there is a potential dermal exposure; any use of the substance without a NIOSH-certified particulate respirator with an APF of at least 10, where there is a potential for inhalation exposures; or any use of the substance resulting in surface water concentrations exceeding 120 ppb may cause serious health effects and significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(i) and (b)(4)(ii).

Recommended testing: EPA has determined that the results of a combined repeated dose toxicity with the reproduction/developmental toxicity screening test (OPPTS Test Guideline 870.3650); a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the human health and environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10834.

Chemical name: 1,6-Hexanediamine, N1-(6-aminohexyl)-, polymer with 2-(chloromethyl)oxirane, N-(dithiocarboxy) derivs., sodium salts.

CAS number: 1459738-70-5.

Basis for action: The PMN states that the substance will be used as a water clarifier intermediate. Based on ecological SAR analysis of test data on analogous dithiocarbamates, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substance in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations that exceed 1 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance that results in surface water concentrations exceeding 1 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a mysid acute toxicity test (OCSPP Test Guideline 850.1035); a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an acute invertebrate toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10835.

Chemical name: Dimethylaminoalkyl alkene amide (generic).

CAS number: Claimed confidential.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as an adjuvant for non-Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)-regulated agricultural use products, an additive for pesticide formulations, and an additive for fertilizer formulations. Based on test data on the PMN substance, as well as ecological SAR analysis of test data on analogous amides and aliphatic amines, EPA predicts chronic toxicity to aquatic organisms may occur at concentrations that exceed 4 ppb of the PMN substance in surface waters for greater than 20 days per year. This 20-day criterion is derived from partial life cycle tests (daphnid chronic and fish early-life stage tests) that typically range from 21 to 28 days in duration. EPA predicts toxicity to aquatic organisms may occur if releases of the PMN substance to surface water exceed releases from the use described in the PMN. For the uses described in the PMN, environmental releases did not exceed the concentration of concern for more than 20 days per year. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that use of the substance other than as described in the PMN may cause significant adverse environmental effects. Based on this information, the PMN substances meet the concern criteria at § 721.170(b)(4)(i) and (b)(4)(ii).

Recommended testing: EPA has determined that the results of a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400) and a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10836.

Chemical name: Substituted naphthalene polymer glycidyl ether (generic).

CAS number: Claimed confidential.

Basis for action: The PMN states that the generic (non-confidential) uses of the substance will be as a matrix resin for composite materials and a binder resin for electronic materials. Based on ecological SAR analysis of test data on analogous polyepoxides, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substance in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations that exceed 1 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 1 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10837.

Chemical name: Alkylpolycarboxylic acid, derivative, tris(fluorinatedalkoxy)alkyl ester salt (generic).

CAS number: Claimed confidential.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be for coatings and printing applications. Based on ecological SAR analysis of test data on analogous anionic surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 6 ppb of the PMN substance in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations that exceed 6 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 6 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a water solubility study (OECD Test Guideline 105); a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); and a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10838.

Chemical name: Tricyclo[3.3.1.13,7]decan-1-amine, N,N-dimethyl-.

CAS number: 3717-40-6.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as an isolated intermediate. Based on ecological SAR analysis of test data on analogous aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 8 ppb of the PMN substance in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations that exceed 8 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined that any use of the substance resulting in surface water concentrations exceeding 8 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10839.

Chemical name: Sulfosuccinic acid ester, alkylamine derivs., sodium salt (generic).

CAS number: Claimed confidential.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as an industrial leather softener. Based on test data on the PMN substance as well as SAR analysis of test data on analogous anionic surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 94 ppb of the PMN substance in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations that exceed 94 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 94 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(i) and (b)(4)(ii).

Recommended testing: EPA has determined that the results of a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400) and a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10840.

Chemical name: Bismuth nitrate oxide (Bi3(NO3)O4).

CAS number: 1417164-49-8.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a proprietary degradation inhibitor additive in polymer-based insulation sheets. Based on test data on analogous respirable, poorly soluble particulates, EPA identified concerns for lung effects from inhalation exposures to the PMN substance. For the use described in the PMN, significant inhalation exposures are not expected. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance other than as listed in the PMN, or without respiratory protection, may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(ii).

Recommended testing: EPA has determined that the results of a 90-day inhalation toxicity study with a 60-day holding period (OPPTS Test Guideline 870.3465) would help characterize the human health effects of the PMN substance.

CFR citation: 40 CFR 721.10841.

Chemical name: Substituted cyclosiloxane (generic).

CAS number: Claimed confidential.

Basis for action: The PMN states that the use of the substance will be as a refractive index modifier component for light-emitting diode (LED) chips. Based on the physical/chemical properties of the PMN substance (as described in the New Chemical Program's PBT category at 64 FR 60194; November 4, 1999) and test data on structurally similar substances, the PMN substance is a potentially persistent, bioaccumulative, and toxic (PBT) chemical. EPA estimates that the PMN substance will persist in the environment more than 2 months and estimates a bioaccumulation factor of greater than or equal to 1,000. As described in the PMN notice, the PMN substance will not be released to water. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance other than as described in the PMN or resulting in releases to water may cause serious health effects and significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(ii), (b)(4)(ii), and (b)(4)(iii).

Recommended testing: EPA has determined that the results of a partition coefficient (n-octanol/water) test, estimation by liquid chromatography (OPPTS Test Guideline 830.7570 or OECD Test Guideline 117); a ready biodegradability test (OPPTS Test Guideline 835.3110 or OECD Test Guideline 301); a fish bioconcentration factor (BCF) test (OPPTS Test Guideline 850.1730 or (OECD Test Guideline 305); and a water solubility test (OECD Test Guideline 111) would help characterize the health and environmental effects of the PMN substance. Depending on the results of these tests, additional testing as identified in the PBT category may be recommended.

CFR citation: 40 CFR 721.10842.

Chemical names: Substituted amide aromatic carboxylic acid, metal salt (generic).

CAS numbers: Claimed confidential.

Basis for action: The PMNs state that the generic (non-confidential) use of the substances will be as morphology modifiers for plastics. Based on ecological SAR analysis of test data on analogous amides, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 67 ppb of the PMN substance (P-14-666) and 39 ppb of the PMN substance (P-14-668) in surface waters for greater than 20 days per year. This 20-day criterion is derived from partial life cycle tests (daphnid chronic and fish early-life stage tests) that typically range from 21 to 28 days in duration. EPA predicts toxicity to aquatic organisms may occur if releases of the substances to surface water, from uses other than as described in the PMNs, exceed releases from the uses described in the PMNs. For the use described in the PMNs, environmental releases did not exceed 67 ppb (P-14-666) and 39 ppb (P-14-668) for more than 20 days per year. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substances may present an unreasonable risk. EPA has determined, however, that any use of the substances other than as listed in the PMNs may cause significant adverse environmental effects. Based on this information, the PMN substances meet the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of a ready biodegradability test (OPPTS Test Guideline 835.3110); a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and an algal toxicity test (OCSPP Test Guideline 850.4500) on each PMN substance would help characterize their environmental effects.

CFR citation: 40 CFR 721.10843.

Chemical name: Graphene nanoplatelets having a predominant thickness of 1-10 layers with lateral dimension predominantly less than 2 microns.

CAS number: Not Available

Effective date of TSCA section 5(e) consent order: December 30, 2014.

Basis for TSCA section 5(e) consent order: The PMN states that the generic (non-confidential) use of the substance will be in printed electronics, solar energy, separations, and functional composites. Based on SAR analysis of test data on respirable, poorly soluble particulates and analogous carbon nanomaterials, EPA identified concerns for pulmonary toxicity, oncogenicity, immunotoxicity, fibrosis, and lung toxicity from lung overload. The order was issued under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I), based on a finding that these substance may present an unreasonable risk of injury to the environment and human health, and there may be significant (or substantial) human exposure to the substance. To protect against these exposures and risks, the consent order requires:

1. Use of personal protective equipment involving impervious gloves and protective clothing (where there is a potential for dermal exposure) and a NIOSH-certified respirator (where there is a potential for inhalation exposure).

2. Establishment and use of a hazard communication program, including human health, environmental hazard precautionary statements on each label and the MSDS.

3. Manufacturing, processing, or use of the PMN substance only as described in the consent order.

4. No use of the PMN substance using an application method that generates a vapor, mist, or aerosol.

5. Submission of certain toxicity testing prior to exceeding the confidential production volume limits of the PMN substances specified in the consent order.

6. No predictable or purposeful release of the PMN substances from manufacturing, processing or use into the waters of the United States.

The SNUR designates as a “significant new use” the absence of these protective measures.

Recommended testing: EPA has determined that the results of certain particle size distribution and material characterization testing would be needed for the PMN substance. The company has agreed to submit the full chemical characterization testing described in the testing section of the consent order within the timeframes identified in the order. Further, depending on the results of the characterization testing, additional toxicity testing may be required at a confidential aggregate manufacture volume, as detailed in the consent order.

CFR citation: 40 CFR 721.10844.

Chemical name: Methanaminium, N-[4-[[4-(dimethylamino)phenyl]phenylmethylene]-2,5-cyclohexadien-1-ylidene]-N-methyl-, ethanedioate, ethanedioate (2:2:1).

CAS number: 2437-29-8.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a component of industrial inks and dyes. Based on test data on analogous malachite green chloride, pararosaniline, gentian violet, crystal violet, oxalic acid, and other analogous substances, EPA identified concerns for mutagenicity, carcinogenicity, eye irritation, as well as kidney, acute, and developmental toxicities for occupational inhalation exposures and general population exposures from drinking water exposures. In addition, based on ecological SAR analysis of test data on analogous cationic dyes, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substance in surface waters. As described in the PMN, occupational exposures during processing and use activities are expected to be minimal. Further, releases of the PMN substance are not expected to result in surface water concentrations that exceed 1 ppb. Therefore, EPA has not determined that the proposed processing or use of the substance may present an unreasonable risk. EPA has determined, however, that any domestic manufacture of the substance, or any release of the substance resulting in surface water concentrations exceeding 1 ppb may cause serious health effects and significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(ii) and (b)(4)(ii).

Recommended testing: EPA has determined that the results of a combined repeated dose toxicity with the reproduction/developmental toxicity screening test (OECD Test Guideline 422); a bacterial reverse mutation test (OECD Test Guideline 471); an in vitro mammalian chromosome aberration test (OECD Test Guideline 473); a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the human health an environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10845.

Chemical name: Sulfurized hydrocarbon (generic).

CAS number: Claimed confidential.

Basis for action: The PMN states that the use of the substance will be as a lubricant additive. Based on ecological SAR analysis of test data on analogous neutral organics, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the low molecular weight components of PMN substance in surface waters. As described in the PMN, where 80 percent of the molecular weight species is greater than 1,000 daltons, releases of the substance are not expected to result in surface water concentrations that exceed 1 ppb of the low molecular weight components. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance where less than 80 percent of the molecular weight species is greater than 1,000 daltons, may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of an inherent biodegradability Zahn-Wellens test (OECD Test Guideline 302); an aerobic and anaerobic transformation in soil test (OECD Test Guideline 307); a fish BCF test: Aqueous and dietary exposure (OECD Test Guideline 305); a bioaccumulation in sediment-dwelling benthic oligochaetes test (OECD Test Guideline 315); a sediment-water chironomid toxicity test using spiked sediment (OECD Test Guideline 218); a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10846.

Chemical name: Oxiranemethanaminium, N,N,N-trimethyl-, bromide.

CAS number: 13895-77-7.

Basis for action: The PMN states that the substance will be used as an intermediate for polymer production. Based on test data on analogous epoxides, EPA identified concerns for skin and lung sensitization, mutagenicity, oncogenicity, developmental toxicity, male reproductive, liver, and kidney toxicity from dermal and inhalation exposures. Further, based on ecological SAR analysis of test data on analogous quaternary ammonium compounds, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 28 ppb of the PMN substance in surface waters. As described in the PMN, particulate exposures are not expected and releases of the substance are not expected to result in surface water concentrations that exceed 28 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any manufacture, processing, or use of the substance in the form of a powder or any use of the substance resulting in surface water concentrations exceeding 28 ppb may cause serious health effects and significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(ii) and (b)(4)(ii).

Recommended testing: EPA has determined that the results of a 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465); a bacterial reverse mutation test (OPPTS Test Guideline 870.5100); a ready biodegradability test (OECD Test Guideline 301D) closed bottle method; a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the human health and environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10847.

Chemical name: Aryloxyalkyl amine (generic).

CAS number: Claimed confidential.

Basis for action: The PMN states that the substance will be used as an intermediate. Based on test data on the PMN substance and SAR analysis of test data on analogous aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 44 ppb of the PMN substance in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations that exceed 44 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use resulting in surface water concentrations exceeding 44 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(i) and (b)(4)(ii).

Recommended testing: EPA has determined that the results of a ready biodegradability test (OECD Test Guideline 301) and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance.

CFR citation: 40 CFR 721.10848.

Chemical names: (P-15-115) Phenol-biphenyl-formaldehyde polycondensate (generic); (P-15-116) Polymer of phenol, biphenyl and resorcinol (generic).

CAS numbers: Claimed confidential.

Basis for action: The PMNs state that the generic (non-confidential) use of the substances will be in electric molding. Based on test data on the PMN substances as well as SAR analysis of test data on analogous phenols, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 5 ppb of the PMN substances in surface waters. As described in the PMNs, releases of the substances are not expected to result in surface water concentrations that exceed 5 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substances may present an unreasonable risk. EPA has determined, however, that any use resulting in surface water concentrations exceeding 5 ppb may cause significant adverse environmental effects. Based on this information, the PMN substances meet the concern criteria at § 721.170(b)(4)(i) and (b)(4)(ii).

Recommended testing: EPA has determined that the results of a water solubility test (OECD Test Guideline 105); a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); and a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would help characterize the environmental effects of the PMN substances. Testing may be conducted on either P-15-115 or P-15-116 and results should include a GPC analysis of molecular weight distribution.

CFR citations: 40 CFR 721.10849 (P-15-115) and 40 CFR 721.10850 (P-15-116)

During review of the PMNs submitted for the chemical substances that are subject to these SNURs, EPA concluded that for 2 of the 22 chemical substances, regulation was warranted under TSCA section 5(e), pending the development of information sufficient to make reasoned evaluations of the health or environmental effects of the chemical substances. The basis for such findings is outlined in Unit IV. Based on these findings, TSCA section 5(e) consent orders requiring the use of appropriate exposure controls were negotiated with the PMN submitters. The SNUR provisions for these chemical substances are consistent with the provisions of the TSCA section 5(e) consent orders. These SNURs are promulgated pursuant to § 721.160 (see Unit VI.).

In the other 20 cases, where the uses are not regulated under a TSCA section 5(e) consent order, EPA determined that one or more of the criteria of concern established at § 721.170 were met, as discussed in Unit IV.

EPA is issuing these SNURs for specific chemical substances which have undergone premanufacture review because the Agency wants to achieve the following objectives with regard to the significant new uses designated in this rule:

• EPA will receive notice of any person's intent to manufacture or process a listed chemical substance for the described significant new use before that activity begins.

• EPA will have an opportunity to review and evaluate data submitted in a SNUN before the notice submitter begins manufacturing or processing a listed chemical substance for the described significant new use.

• EPA will be able to regulate prospective manufacturers or processors of a listed chemical substance before the described significant new use of that chemical substance occurs, provided that regulation is warranted pursuant to TSCA sections 5(e), 5(f), 6, or 7.

• EPA will ensure that all manufacturers and processors of the same chemical substance that is subject to a TSCA section 5(e) consent order are subject to similar requirements.

Issuance of a SNUR for a chemical substance does not signify that the chemical substance is listed on the TSCA Chemical Substance Inventory (TSCA Inventory). Guidance on how to determine if a chemical substance is on the TSCA Inventory is available on the Internet at http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html.

EPA is issuing these SNURs as a direct final rule, as described in § 721.160(c)(3) and § 721.170(d)(4). In accordance with § 721.160(c)(3)(ii) and § 721.170(d)(4)(i)(B), the effective date of this rule is August 4, 2015 without further notice, unless EPA receives written adverse or critical comments, or notice of intent to submit adverse or critical comments before July 6, 2015.

If EPA receives written adverse or critical comments, or notice of intent to submit adverse or critical comments, on one or more of these SNURs before July 6, 2015, EPA will withdraw the relevant sections of this direct final rule before its effective date. EPA will then issue a proposed SNUR for the chemical substance(s) on which adverse or critical comments were received, providing a 30-day period for public comment.

This rule establishes SNURs for a number of chemical substances. Any person who submits adverse or critical comments, or notice of intent to submit adverse or critical comments, must identify the chemical substance and the new use to which it applies. EPA will not withdraw a SNUR for a chemical substance not identified in the comment.

To establish a significant new use, EPA must determine that the use is not ongoing. The chemical substances subject to this rule have undergone premanufacture review. In cases where EPA has not received a notice of commencement (NOC) and the chemical substance has not been added to the TSCA Inventory, no person may commence such activities without first submitting a PMN. Therefore, for chemical substances for which an NOC has not been submitted EPA concludes that the designated significant new uses are not ongoing.

When chemical substances identified in this rule are added to the TSCA Inventory, EPA recognizes that, before the rule is effective, other persons might engage in a use that has been identified as a significant new use. However, TSCA section 5(e) consent orders have been issued for 2 of the 22 chemical substances, and the PMN submitters are prohibited by the TSCA section 5(e) consent orders from undertaking activities which would be designated as significant new uses. The identities of 16 of the 22 chemical substances subject to this rule have been claimed as confidential and EPA has received no post-PMN bona fide submissions (per §§ 720.25 and 721.11). Based on this, the Agency believes that it is highly unlikely that any of the significant new uses described in the regulatory text of this rule are ongoing.

Therefore, EPA designates June 5, 2015 as the cutoff date for determining whether the new use is ongoing. Persons who begin commercial manufacture or processing of the chemical substances for a significant new use identified as of that date would have to cease any such activity upon the effective date of the final rule. To resume their activities, these persons would have to first comply with all applicable SNUR notification requirements and wait until the notice review period, including any extensions, expires. If such a person met the conditions of advance compliance under § 721.45(h), the person would be considered exempt from the requirements of the SNUR. Consult the Federal Register document of April 24, 1990 for a more detailed discussion of the cutoff date for ongoing uses.

EPA recognizes that TSCA section 5 does not require developing any particular test data before submission of a SNUN. The two exceptions are:

1. Development of test data is required where the chemical substance subject to the SNUR is also subject to a test rule under TSCA section 4 (see TSCA section 5(b)(1)).

2. Development of test data may be necessary where the chemical substance has been listed under TSCA section 5(b)(4) (see TSCA section 5(b)(2)).

In the absence of a TSCA section 4 test rule or a TSCA section 5(b)(4) listing covering the chemical substance, persons are required only to submit test data in their possession or control and to describe any other data known to or reasonably ascertainable by them (see 40 CFR 720.50). However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing. In cases where EPA issued a TSCA section 5(e) consent order that requires or recommends certain testing, Unit IV. lists those tests. Unit IV. also lists recommended testing for non-5(e) SNURs. Descriptions of tests are provided for informational purposes. EPA strongly encourages persons, before performing any testing, to consult with the Agency pertaining to protocol selection. To access the OCSPP test guidelines referenced in this document electronically, please go to http://www.epa.gov/ocspp and select “Test Methods and Guidelines.” The Organisation for Economic Co-operation and Development (OECD) test guidelines are available from the OECD Bookshop at http://www.oecdbookshop.org or SourceOECD at http://www.sourceoecd.org.

In the TSCA section 5(e) consent orders for several of the chemical substances regulated under this rule, EPA has established production volume limits in view of the lack of data on the potential health and environmental risks that may be posed by the significant new uses or increased exposure to the chemical substances. These limits cannot be exceeded unless the PMN submitter first submits the results of toxicity tests that would permit a reasoned evaluation of the potential risks posed by these chemical substances. Under recent TSCA section 5(e) consent orders, each PMN submitter is required to submit each study before reaching the specified production limit. Listings of the tests specified in the TSCA section 5(e) consent orders are included in Unit IV. The SNURs contain the same production volume limits as the TSCA section 5(e) consent orders. Exceeding these production limits is defined as a significant new use. Persons who intend to exceed the production limit must notify the Agency by submitting a SNUN at least 90 days in advance of commencement of non-exempt commercial manufacture, or processing.

The recommended tests specified in Unit IV. may not be the only means of addressing the potential risks of the chemical substance. However, submitting a SNUN without any test data may increase the likelihood that EPA will take action under TSCA section 5(e), particularly if satisfactory test results have not been obtained from a prior PMN or SNUN submitter. EPA recommends that potential SNUN submitters contact EPA early enough so that they will be able to conduct the appropriate tests.

SNUN submitters should be aware that EPA will be better able to evaluate SNUNs which provide detailed information on the following:

• Human exposure and environmental release that may result from the significant new use of the chemical substances.

• Potential benefits of the chemical substances.

• Information on risks posed by the chemical substances compared to risks posed by potential substitutes.

By this rule, EPA is establishing certain significant new uses which have been claimed as CBI subject to Agency confidentiality regulations at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a final determination or other disposition of the confidentiality claim under 40 CFR part 2 procedures, EPA is required to keep this information confidential. EPA promulgated a procedure to deal with the situation where a specific significant new use is CBI, at 40 CFR 721.1725(b)(1).

Under these procedures a manufacturer or processor may request EPA to determine whether a proposed use would be a significant new use under the rule. The manufacturer or processor must show that it has a bona fide intent to manufacture or process the chemical substance and must identify the specific use for which it intends to manufacture or process the chemical substance. If EPA concludes that the person has shown a bona fide intent to manufacture or process the chemical substance, EPA will tell the person whether the use identified in the bona fide submission would be a significant new use under the rule. Since most of the chemical identities of the chemical substances subject to these SNURs are also CBI, manufacturers and processors can combine the bona fide submission under the procedure in § 721.1725(b)(1) with that under § 721.11 into a single step.

If EPA determines that the use identified in the bona fide submission would not be a significant new use, i.e., the use does not meet the criteria specified in the rule for a significant new use, that person can manufacture or process the chemical substance so long as the significant new use trigger is not met. In the case of a production volume trigger, this means that the aggregate annual production volume does not exceed that identified in the bona fide submission to EPA. Because of confidentiality concerns, EPA does not typically disclose the actual production volume that constitutes the use trigger. Thus, if the person later intends to exceed that volume, a new bona fide submission would be necessary to determine whether that higher volume would be a significant new use.

According to § 721.1(c), persons submitting a SNUN must comply with the same notification requirements and EPA regulatory procedures as persons submitting a PMN, including submission of test data on health and environmental effects as described in 40 CFR 720.50. SNUNs must be submitted on EPA Form No. 7710-25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in 40 CFR 720.40 and § 721.25. E-PMN software is available electronically at http://www.epa.gov/opptintr/newchems.

EPA has evaluated the potential costs of establishing SNUN requirements for potential manufacturers and processors of the chemical substances subject to this rule. EPA's complete economic analysis is available in the docket under docket ID number EPA-HQ-OPPT-2015-0220.

This action establishes SNURs for several new chemical substances that were the subject of PMNs, or TSCA section 5(e) consent orders. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993).

According to PRA (44 U.S.C. 3501 et seq.), an agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register, are listed in 40 CFR part 9, and included on the related collection instrument or form, if applicable. EPA is amending the table in 40 CFR part 9 to list the OMB approval number for the information collection requirements contained in this action. This listing of the OMB control numbers and their subsequent codification in the CFR satisfies the display requirements of PRA and OMB's implementing regulations at 5 CFR part 1320. This Information Collection Request (ICR) was previously subject to public notice and comment prior to OMB approval, and given the technical nature of the table, EPA finds that further notice and comment to amend it is unnecessary. As a result, EPA finds that there is “good cause” under section 553(b)(3)(B) of the Administrative Procedure Act (5 U.S.C. 553(b)(3)(B)) to amend this table without further notice and comment.

The information collection requirements related to this action have already been approved by OMB pursuant to PRA under OMB control number 2070-0012 (EPA ICR No. 574). This action does not impose any burden requiring additional OMB approval. If an entity were to submit a SNUN to the Agency, the annual burden is estimated to average between 30 and 170 hours per response. This burden estimate includes the time needed to review instructions, search existing data sources, gather and maintain the data needed, and complete, review, and submit the required SNUN.

Send any comments about the accuracy of the burden estimate, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques, to the Director, Collection Strategies Division, Office of Environmental Information (2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001. Please remember to include the OMB control number in any correspondence, but do not submit any completed forms to this address.

On February 18, 2012, EPA certified pursuant to RFA section 605(b) (5 U.S.C. 601 et seq.), that promulgation of a SNUR does not have a significant economic impact on a substantial number of small entities where the following are true:

1. A significant number of SNUNs would not be submitted by small entities in response to the SNUR.

2. The SNUR submitted by any small entity would not cost significantly more than $8,300.

A copy of that certification is available in the docket for this action.

This action is within the scope of the February 18, 2012 certification. Based on the Economic Analysis discussed in Unit XI. and EPA's experience promulgating SNURs (discussed in the certification), EPA believes that the following are true:

• A significant number of SNUNs would not be submitted by small entities in response to the SNUR.

• Submission of the SNUN would not cost any small entity significantly more than $8,300.

Based on EPA's experience with proposing and finalizing SNURs, State, local, and Tribal governments have not been impacted by these rulemakings, and EPA does not have any reasons to believe that any State, local, or Tribal government will be impacted by this action. As such, EPA has determined that this action does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments subject to the requirements of UMRA sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.).

This action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999).

This action does not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This action does not significantly nor uniquely affect the communities of Indian Tribal governments, nor does it involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), do not apply to this action.

This action is not subject to Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because this is not an economically significant regulatory action as defined by Executive Order 12866, and this action does not address environmental health or safety risks disproportionately affecting children.

This action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001), because this action is not expected to affect energy supply, distribution, or use and because this action is not a significant regulatory action under Executive Order 12866.

In addition, since this action does not involve any technical standards, NTTAA section 12(d) (15 U.S.C. 272 note), does not apply to this action.

This action does not entail special considerations of environmental justice related issues as delineated by Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, 40 CFR parts 9 and 721 are amended as follows:

Throughout this document, the terms “we,” “us,” or “our” refer to EPA. This section provides additional information by addressing the following:

On March 6, 2015, (80 FR 12109), EPA published a notice of proposed rulemaking (NPR) for the State of Kansas. The NPR proposed approval of Kansas' submission that provides the basic elements specified in section 110(a)(2) of the CAA, or portions thereof, necessary to implement, maintain, and enforce the 2010 SO2 NAAQS.

On July 15, 2013, EPA received a SIP submission from the state of Kansas that address the infrastructure elements specified in section 110(a)(2) for the 2010 SO2 NAAQS. The submissions addressed the following infrastructure elements of section 110(a)(2): (A), (B), (C), (D), (E), (F), (G), (H), (J), (K), (L), and (M). Specific requirements of section 110(a)(2) of the CAA and the rationale for EPA's proposed action to approve the SIP submission are explained in the NPR and will not be restated here. No public comments were received on the NPR.

EPA is approving Kansas' submission which provides the basic program elements specified in section 110(a)(2)(A), (B), (C), (D)(i)(II) (prongs 3 and 4), (D)(ii) (E), (F), (G), (H), (J), (K), (L), and (M) of the CAA, or portions thereof, necessary to implement, maintain, and enforce the 2010 SO2 NAAQS, as a revision to the Kansas SIP. This action is being taken under section 110 of the CAA. As discussed in each applicable section of the NPR, EPA is not acting on section 110(a)(2)(D)(i)(I), and section 110(a)(2)(I)—Nonattainment Area Plan or Plan Revisions Under part D.

Under the CAA the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

• does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);

• is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.);

• does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and

• does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

The SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 4, 2015. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2)).

For the reasons stated in the preamble, the EPA is amending 40 CFR part 52 as set forth below:

I. Background

On March 14, 2014 (79 FR 14460), EPA published a notice of proposed rulemaking (NPR) for West Virginia. In the NPR, EPA proposed approval of West Virginia's progress report SIP, a report on progress made in the first implementation period towards RPGs for Class I areas in and outside West Virginia that are affected by emissions from West Virginia's sources. This progress report SIP and accompanying cover letter also included a determination that West Virginia's existing regional haze SIP requires no substantive revision to achieve the established regional haze visibility improvement and emissions reduction goals for 2018. On March 10, 2015 (80 FR 12607), EPA published a supplemental NPR (SNPR) to address the potential effects on EPA's proposed approval from the April 29, 2014 decision of the United States Supreme Court in EPA v. EME Homer City Generation, L.P., 134 S. Ct. 1584 (2014), remanding to the United States Court of Appeals for the District of Columbia Circuit (D.C. Circuit) EPA's Cross-State Air Pollution Rule (CSAPR) for further proceedings and the D.C. Circuit's decision to lift the stay of CSAPR.

States are required to submit a progress report in the form of a SIP revision every five years that evaluates progress towards the RPGs for each mandatory Class I Federal area 1 within the state and in each mandatory Class I Federal area outside the state which may be affected by emissions from within the state. See 40 CFR 51.308(g). In addition, the provisions under 40 CFR 51.308(h) require states to submit, at the same time as the 40 CFR 51.308(g) progress report, a determination of the adequacy of the state's existing regional haze SIP. The first progress report SIP is due five years after submittal of the initial regional haze SIP. On June 18, 2008, WVDEP submitted its regional haze SIP in accordance with the requirements of 40 CFR 51.308.2 The progress report SIP revision was submitted by West Virginia on April 30, 2013 and EPA finds that it satisfies the requirements of 40 CFR 51.308(g) and (h).

On April 30, 2013, West Virginia submitted a SIP revision to describe the progress made towards the RPGs of Class I areas in and outside West Virginia that are affected by emissions from West Virginia's sources. This progress report SIP also includes a determination of the adequacy of West Virginia's existing regional haze SIP to achieve these RPGs.

West Virginia has two Class I areas within its borders: Dolly Sods Wilderness Area (Dolly Sods) and Otter Creek Wilderness Area (Otter Creek). West Virginia notes in its progress report SIP that West Virginia sources were also identified, through an area of influence modeling analysis based on back trajectories, as potentially impacting nine Class I areas in five neighboring states: Brigantine Wilderness in New Jersey; Great Smoky Mountains National Park in North Carolina and Tennessee; James River Face Wilderness in Virginia; Linville Gorge Wilderness in North Carolina; Monmouth Cave National Park in Kentucky; and Shenandoah National Park in Virginia.

The provisions in 40 CFR 51.308(g) require a progress report SIP to address seven elements. EPA finds that West Virginia's progress report SIP addressed each element under 40 CFR 51.308(g). The seven elements and EPA's conclusion are briefly summarized in this rulemaking action.

The provisions in 40 CFR 51.308(g) require progress report SIPs to include a description of the status of measures in the approved regional haze SIP; a summary of emissions reductions achieved; an assessment of visibility conditions for each Class I area in the state; an analysis of changes in emissions from sources and activities within the state; an assessment of any significant changes in anthropogenic emissions within or outside the state that have limited or impeded progress in Class I areas impacted by the state's sources; an assessment of the sufficiency of the approved regional haze SIP; and a review of the state's visibility monitoring strategy. As explained in detail in the NPR and SNPR, EPA finds that West Virginia's progress report SIP addressed each element and has therefore satisfied the requirements under 40 CFR 51.308(g).

In addition, pursuant to 40 CFR 51.308(h), states are required to submit, at the same time as the progress report SIP, a determination of the adequacy of their existing regional haze SIP and to take one of four possible actions based on information in the progress report. One possible action is submission of a negative declaration to EPA that no further substantive revision to the state's existing regional haze SIP is needed. In its progress report SIP, West Virginia submitted a negative declaration that it had determined that its existing regional haze SIP requires no further substantive revision to achieve the RPGs for the Class I areas that are affected by emissions from West Virginia's sources. As explained in detail in the NPR and SNPR, EPA concludes West Virginia has adequately addressed 40 CFR 51.308(h) because the visibility data trends at the Class I areas impacted by West Virginia's sources and the emissions trends of the largest emitters of visibility-impairing pollutants both indicate that the RPGs for 2018 will be met or exceeded. Therefore, EPA concludes West Virginia's progress report SIP meets the requirements of 40 CFR 51.308(h).

EPA received comments on the proposed rulemaking from the National Parks Conservation Association (Commenter). EPA received one additional comment on the SNPR from the Utility Air Regulatory Group (SNPR Commenter) in support of our proposed approval of West Virginia's progress report SIP. A full set of the comments are provided in the docket for today's final rulemaking action. A summary of the significant comments and the EPA's response is provided in this section.

Comment 1: The Commenter stated that EPA should not approve the West Virginia progress report SIP revision because the report does not meet the requirements of 40 CFR 51.308(g)(2). The Commenter stated that the West Virginia progress report describes emission reductions in West Virginia but fails to detail specific reductions achieved through implementation of specific measures in the West Virginia regional haze SIP. The Commenter claimed that the report neither demonstrates that regional haze SIP measures are working nor that emission reductions or visibility improvement has resulted from enforceable requirements in the regional haze SIP and not from “outside forces.” More specifically, the Commenter claimed that reductions in sulfur dioxide (SO2) emissions from electric generating units (EGUs) from shutdowns, fuel switches, addition of controls, shifting to the use of cleaner units, and a decrease in demand were reversible if not enforceable. The Commenter stated that emission reductions cannot be relied upon if not enforceable and requested EPA provide the reductions achieved through West Virginia's regional haze SIP and revise its assessment of the SIP revision.

Response 1: EPA disagrees with the Commenter's assertion that West Virginia has not adequately addressed 40 CFR 51.308(g)(2) and that EPA cannot accordingly approve West Virginia's progress report SIP revision. While the regulations at 40 CFR 51.308(g)(2) require a summary of the emissions reductions achieved in the State through the measures in its regional haze SIP, there is nothing in this provision requiring a detailed, causal analysis pinpointing or linking specific emission reductions to specific regional haze SIP measures.

The Commenter's argument that West Virginia must specifically link specific measures in the regional haze SIP to changes in emissions inventories appears to be based on a misunderstanding of the design of the regional haze program and the purpose of the mid-course progress reports. The Regional Haze Rule,3 which was promulgated not long after the 1997 revisions to the ozone and fine particulate matter (PM2.5) National Ambient Air Quality Standards (NAAQS), was explicitly designed to facilitate the coordination of emissions management strategies for regional haze with those needed to implement the NAAQS. See 64 FR 35713, 35719-35720 (July 1, 1999). More generally, the Regional Haze Rule requires states to include all air quality improvements that will be achieved by other CAA programs and state air pollution control requirements when assessing changes in emissions and visibility to be expected during the period of their regional haze SIP. 64 FR at 35733. This is made clear in the haze regulations which prohibit states from adopting RPGs that represent less visibility improvement than is expected to result from the implementation of other CAA requirements during the planning period. 40 CFR 51.308(d)(1)(vi). Given this requirement, states included in their regional haze SIPs a number of Federal regulations for mobile and stationary sources that had or were expected to come into effect after the baseline period and that were anticipated to result in reductions of visibility impairing pollutants. These regulations included NAAQS implementation measures as well as other CAA requirements, such as mobile source rules or Maximum Achievable Control Technology (MACT) standards issued under section 112 of the CAA. As one example, West Virginia included the 2007 Heavy-Duty Highway Rule (40 CFR part 86, subpart P) in its regional haze SIP. In short, West Virginia, like other states, included in its regional haze SIP anticipated reductions in emissions during the baseline period arising from a number of Federal CAA measures, as required by the Regional Haze Rule.

Thus, states took into account the anticipated emission reductions from a wide range of measures in setting RPGs. To model the visibility conditions in 2018, states used projected emission inventories based on the best information before them. Given the significance of emissions from EGUs to haze, these projections were based, among other things, on expected changes in energy demand affecting capacity utilization of power plants. States also sometimes included an emissions buffer to account for the possible construction of new power plants or other types of facilities. States also took into account, as described above, anticipated reductions in emissions resulting from recent Federal rules addressing non-visibility-related requirements, as well as consent decrees, significant measures adopted by nearby states, and specific measures to address the requirements of the visibility program. Thus, in forecasting future visibility conditions, states by design took into account to the extent possible “outside forces” and a host of overlapping requirements.

The type of analysis underlying the RPGs established in regional haze SIPs involves a fair degree of uncertainty. Changes in economic conditions, fluctuations in the prices of fuels, the remand of a CAA requirement by the courts, or the passage of new regulations are some of the factors that may occur and can impact emissions inventories and monitored visibility conditions. Because each planning period requires states to forecast conditions ten or more years into the future, EPA required a mid-course evaluation of the regional haze SIP. The purpose of this progress report is to “check in” with the state to determine whether its predictions regarding future visibility remain reasonable. The purpose of summarizing the emission reductions throughout the state from the measures in the regional haze SIP is to ensure that no dramatic or unexpected changes in emissions inventories have rendered unreliable the earlier projections of emissions in 2018.

In West Virginia's progress report SIP, EPA believes that West Virginia provided a reasonable summary of the emissions reductions achieved through the measures in the regional haze SIP by focusing on those sources of pollution in West Virginia with the biggest impact on haze. Because SO2 reductions from West Virginia's EGUs are the key element of the State's regional haze strategy, West Virginia discussed in its progress report SIP the significant SO2 emission reductions from EGUs since submittal of its regional haze SIP. West Virginia also assessed the downward trend in SO2 emissions and emission rates in comparison to heat input at these units and concluded that overall the data was indicative of the fact that the reductions were the result of the installation of controls and the use of cleaner burning fuels. See West Virginia State Implementation Plan Revision: Regional Haze 5-Year Periodic Report (Covering 2008-2013), Section 3.1 (April 30, 2013).4 Although West Virginia did not link the specific reductions in the emission inventory to specific measures in the regional haze SIP, the State did provide source-specific information on its coal-fired EGUs. For each of these units, the State identified the current status of SO2 controls and shutdowns as well as the projected controls and shutdowns that were included in the regional haze SIP and the estimated and actual SO2 reductions in 2009. Id. at p. 50-54 (Table 16). Taken together, West Virginia's summary of the SO2 emissions reductions is sufficient for the State to evaluate whether a mid-course correction in its regional haze SIP is needed. As West Virginia's progress report shows, emissions from these facilities are far below what was projected in its regional haze SIP.

In sum, EPA believes West Virginia sufficiently discussed in its progress report SIP revision the emission reductions which resulted from numerous enforceable requirements found in West Virginia's regional haze SIP. West Virginia's progress report discussed numerous Federal and state enforceable measures which are responsible for emissions reductions in West Virginia and which correlate to improved visibility, including the Clean Air Interstate Rule (CAIR), the MACT programs, the 2007 Heavy-Duty Highway Rule, the Tier 2 Vehicle and Gasoline Sulfur Program, the Nonroad Diesel Emissions Program, Federal consent decrees resolving enforcement actions against EGUs and non-EGUs, and best available retrofit technology (BART) determinations for sources located within West Virginia and sources within a 300 kilometer radius of Dolly Sods or Otter Creek. West Virginia also discussed measures from other states which may have led to improvements in visibility in West Virginia including the North Carolina Clean Smokestacks Act, Georgia Multipollutant Control for Electric Utility Steam Generating Units, and the Maryland Health Air Act. Additionally, in the progress report SIP revision, West Virginia compared emissions inventories prior to and after the implementation of the West Virginia regional haze SIP, a comparison which show substantial reductions of visibility impairing pollutants such as SO2. Because West Virginia demonstrated that these Federal and state enforceable measures contributed to the reduction of visibility impairing pollutants, EPA concluded West Virginia adequately addressed 40 CFR 51.308(g)(2) requirements for a summary of emission reductions in its progress report. Therefore, EPA disagrees with the Commenter that EPA should disapprove the West Virginia progress report SIP and disagrees that any further information or analysis is required.

Comment 2: The Commenter claimed that West Virginia's progress report SIP revision did not meet the requirements of 40 CFR 51.308(g)(3) because the visibility data presented by West Virginia appeared within a graph and was not quantified in a clear, tabular manner. Additionally, the Commenter alleged that West Virginia confused the State's meeting the uniform rate of progress for Dolly Sods with meeting its RPGs for Dolly Sods.

Response 2: EPA disagrees with the Commenter that West Virginia's progress report is lacking the required visibility monitoring information. 40 CFR 51.308(g)(3) only requires the following visibility information measured in deciviews for the most impaired and least impaired days for each area, with values expressed in terms of five-year averages of these annual values: (1) Current visibility conditions; (2) the difference between current visibility conditions and baseline visibility conditions; and (3) the change in visibility impairment over the past five years. Nothing in 40 CFR 51.308(g)(3) requires the visibility data to be provided in a tabular format versus the graphical format used in West Virginia's progress report, even though a tabular format may facilitate easier review of the data. As stated in our NPR, EPA believes West Virginia provided the required information regarding visibility conditions and changes to meet the requirements under 40 CFR 51.308(g)(3), specifically providing current conditions based on the latest available Interagency Monitoring of Protected Visual Environments (IMPROVE) monitoring data, the difference between current visibility conditions and baseline visibility conditions, and the change in visibility impairment over the most recent five-year period for which data were available at the time of the progress report SIP development. EPA believes the fact that West Virginia presented this required information in graphical versus tabular format is irrelevant to our conclusion that West Virginia adequately addressed requirements in 40 CFR 51.308(g)(3).

While EPA agrees with the Commenter that West Virginia did inadvertently state in its progress report on one page that it was “meeting its RPG” for Dolly Sods, EPA disagrees with the Commenter that this inadvertent misstatement has any relevance to the approvability of West Virginia's progress report generally or to EPA's conclusion that West Virginia has adequately addressed 40 CFR 51.308(g)(3) specifically, as discussed above and in the NPR. In particular, West Virginia appropriately discussed in its progress report on pages 59-60 that an analysis of emission reductions in West Virginia indicates the State is “on track to achieve” its RPGs in 2018 at Dolly Sods and that visibility at Dolly Sods had significantly improved since 2000. West Virginia's progress report also graphically displayed the State's progress towards its RPGs at Dolly Sods for 2018. Therefore, EPA views West Virginia's statement on one page that it is “meeting its RPG” as inadvertent as West Virginia otherwise correctly indicates in its progress report that the State is making reasonable progress towards achieving its RPGs at Dolly Sods by 2018. While EPA agrees with the Commenter that further emission reductions are needed for West Virginia to meet fully its RPGs in 2018 at Dolly Sods, EPA concludes West Virginia has appropriately addressed requirements of 40 CFR 51.308(g)(3) through its presentation of visibility data. For the reasons discussed herein and discussed more fully in our NPR, EPA believes West Virginia has demonstrated it is making reasonable progress towards its RPGs for 2018 and that its regional haze SIP is adequate, requiring no further revisions to the regional haze SIP at this time for any additional emission reduction requirements for West Virginia to achieve its RPGs in 2018.

Comment 3: The Commenter alleged that West Virginia's progress report SIP revision does not meet the requirements of 40 CFR 51.308(g)(6). The Commenter stated EPA's proposed approval of the West Virginia progress report SIP left unexamined West Virginia's assertion it was on track to meet its RPGs in 2018 and did not quantify how West Virginia's emission reductions would continue. The Commenter claimed projected emission reductions from Federal programs like the Mercury Air Toxics Standards (MATS) for EGUs and the 2010 SO2 NAAQS are neither quantified nor necessarily enforceable at this time. Additionally, the Commenter claimed none of the annual visibility values for Dolly Sods have yet achieved the RPGs and therefore more emission reductions are necessary. The Commenter stated EPA and West Virginia have avoided review of additional controls on non-EGUs. The Commenter claimed West Virginia committed in its regional haze SIP to review the need for additional controls at non-EGUs in its five-year progress report and therefore inappropriately concluded in its progress report that additional controls on non-EGUs were not necessary as the State was making progress towards its RPGs. The Commenter asserted some initial emission reductions in West Virginia resulted from controls, fuel switches, and shutdowns and as such are not necessarily enforceable. The Commenter claimed these reductions must be maintained and additional enforceable reductions from other source categories will be needed for West Virginia to meet its RPGs by 2018.

Response 3: EPA disagrees with the Commenter's allegation that West Virginia's progress report SIP revision does not meet the requirements of 40 CFR 51.308(g)(6). EPA views this requirement as a qualitative assessment, in light of emissions and visibility trends and other readily available information, as to whether Class I areas affected by emissions from a state are on track to meet their 2018 RPGs. See Progress Report General Principles at 16. In the NPR, EPA has described in detail how West Virginia's progress report provides such a qualitative assessment that Class I areas impacted by emissions from sources within West Virginia are on track to achieve their RPGs by 2018. EPA believes that the enforceable measures taken into consideration in West Virginia's regional haze SIP have contributed to the significant emissions reductions in West Virginia as discussed in the progress report, particularly in the visibility impairing pollutant SO2. West Virginia's progress report included visibility monitoring data which clearly demonstrated visibility improvement in the Class I areas impacted by West Virginia sources. Even though the emissions reductions are not specifically linked causally to specific measures in the State's regional haze SIP, EPA believes the enforceable measures in the SIP do and will continue to contribute to reductions in emissions and that these measures have led to the visibility improvement indicated by monitored data contained in West Virginia's progress report SIP revision submittal. While West Virginia in its progress report did identify several factors not in the West Virginia regional haze SIP such as shutdowns and fuel switches that have reduced emissions from sources within the State, West Virginia did not rely on these to demonstrate that the implementation plan for the State is sufficient for purposes of this review. West Virginia included a discussion of these factors in the progress report to make clear that additional factors beyond the measures in the SIP and federal implementation plan (FIP) have contributed to the large emissions reductions seen throughout the state, particularly in SO2 emissions which have been identified as the primary contributor to visibility impairment in West Virginia and in the Visibility Improvement State and Tribal Association of the Southeast (VISTAS) region. West Virginia did not account for these factors in its original regional haze SIP as the shutdowns and fuel switches occurred after the development of the regional haze SIP and in many cases are not enforceable, as noted by the commenter. However, for this progress report SIP revision and to address requirements in 40 CFR 51.308(g)(1)-(7), including 40 CFR 51.308(g)(6) specifically, West Virginia only needed to show that it is on track to achieve its RPGs in 2018. According to the monitored visibility data presented in the State's progress report SIP submittal, West Virginia is on the glidepath to meeting its RPGs by 2018, and the Class I areas impacted by West Virginia sources are also on track to meet their RPGs by 2018. In addition, as discussed in the West Virginia progress report SIP submittal, many of the Federal and state measures in West Virginia's regional haze SIP are just beginning to be implemented and as such further emission reductions, particularly in SO2 emissions, can be expected which will enable West Virginia to continue to make further progress towards its RPGs for 2018.5 Therefore, EPA disagrees with the commenters' assertion that more emissions reduction measures particularly from non-EGUs are needed for West Virginia's regional haze SIP for Dolly Sods and Otter Creek (or other Class I areas impacted by West Virginia emissions) to meet RPGs.

Comment 4: The Commenter stated that EPA cannot approve West Virginia's progress report as it relies on CAIR. The Commenter stated CAIR was “struck down” by the D.C. Circuit as fundamentally flawed. The Commenter also generally challenged the legality of using CAIR to meet any regional haze requirements. The Commenter “reiterated” its prior comments that CAIR is ill-suited to address regional haze and that EPA cannot use a “cap-and-trade” program with yearly averaging to address sources with hourly effects on Class I areas. The Commenter stated the lack of source-specific BART is an impediment to the implementation of the regional haze program. In addition, the Commenter stated that EPA had previously issued a limited disapproval of West Virginia's regional haze SIP due to reliance on CAIR. The Commenter stated EPA had also previously said in a rulemaking on Florida's regional haze SIP that the five year progress report would be the appropriate time to address any necessary changes to reasonable progress goal demonstrations and long term strategies. The Commenter mentioned both West Virginia's regional haze SIP and progress report SIP rely heavily on CAIR for modeling assumptions, controls, emission estimates, and as an alternative to source-specific BART requirements for EGUs. The Commenter mentioned EPA only addressed CAIR in the proposed approval of the progress report when discussing the limited disapproval of West Virginia's regional haze SIP and stated EPA's approval of the West Virginia progress report was inconsistent with prior EPA positions, unsupported by the facts and arbitrary and capricious as a matter of law.

Response 4: EPA disagrees with the Commenter that EPA cannot approve West Virginia's five year progress report because the progress report relies on emission reductions from CAIR or because portions of West Virginia's regional haze SIP relied on CAIR.6 On March 23, 2012 (77 FR 16937), EPA finalized a limited approval and limited disapproval of West Virginia's June 18, 2008 regional haze SIP to address the first implementation period for regional haze.7 There was a limited disapproval of this SIP because of West Virginia's reliance on CAIR to meet certain regional haze requirements.8 In our SNPR, EPA described the litigation history and status of CAIR in great detail, including the fact that CAIR was replaced with CSAPR (76 FR 48208 (August 8, 2011)) after West Virginia had developed and submitted its regional haze SIP. CSAPR requires substantial reductions of SO2 and NOX emissions from EGUs in 28 states in the Eastern United States that significantly contribute to downwind nonattainment of the 1997 PM2.5 and ozone NAAQS and 2006 PM2.5 NAAQS. On January 1, 2015, EPA sunset CAIR and began implementing CSAPR after the D.C. Circuit lifted the stay on CSAPR following the Supreme Court's decision upholding CSAPR.

As explained in detail in the SNPR and here in summary fashion, EPA does not believe that the status of CAIR or CSAPR affects the approvability of West Virginia's progress report SIP for several reasons. First, CAIR was in effect for the period of time addressed by West Virginia's progress report (2008-2013). Therefore, West Virginia appropriately evaluated and relied on CAIR reductions from EGUs of significant emissions of NOX and SO2 to demonstrate the State's progress towards meeting its RPGs.9 EPA's intention in requiring the progress reports pursuant to 40 CFR 51.308(g) was for the states to demonstrate progress achieved during the current implementation period addressed by the regional haze SIP. Thus, West Virginia appropriately relied upon CAIR reductions for demonstrating progress towards its RPGs from 2008-2013. And as explained in the SNPR, given that CAIR was in place until recently, it is appropriate to rely on CAIR emission reductions during this period for purposes of assessing the adequacy of West Virginia's progress report pursuant to 40 CFR 51.308(g) and (h).

Second, the State's regional haze program now includes reliance on CSAPR for SO2 and NOX reductions, at least throughout the remainder of this first implementation period until 2018. EPA's June 7, 2012 FIP replaced West Virginia's reliance on CAIR with reliance on CSAPR to meet certain regional haze requirements. Because the Regional Haze Rule discusses requirements for “implementation plans” which are defined in the visibility program to include approved SIPs or FIPs, EPA considered measures in its June 7, 2012 regional haze FIP as well as in the State's regional haze SIP in assessing the State's progress report for 40 CFR 51.308(g) and (h). EPA explained in the SNPR that the requirements of the regional haze program are fully addressed in West Virginia through its SIP and the FIP issued by EPA. As also discussed in the SNPR, EPA expects the SO2 and NOX emissions reductions at EGUs in West Virginia to continue through the remainder of the first implementation period in 2018 due to implementation of CSAPR.

Finally, the Regional Haze Rule provides for continual evaluation and assessment of a state's reasonable progress towards achieving the national goal of natural visibility conditions. West Virginia has the opportunity to reassess its RPGs and the adequacy of its regional haze SIP, including reliance upon CSAPR for emission reductions from EGUs, when it prepares and submits its second regional haze SIP to cover the implementation period from 2018 through 2028 or when the State prepares its next periodic progress report. However, as evaluated for this progress report, emissions of SO2 from EGUs are presently far below original projections for 2018, visibility data provided by West Virginia show the Federal Class I areas impacted by West Virginia sources are all on track to achieve their RPGs, and EPA expects SO2 emission reductions in West Virginia to continue through CSAPR and MATS and through expected EGU deactivations scheduled for 2015. These continued emission reductions will assist West Virginia in making reasonable progress towards natural visibility conditions in 2064. As further measures will be needed to make continued progress towards the national goal, West Virginia has the opportunity to include such measures in subsequent SIPs for future implementation periods. See Commonwealth of Virginia, et al., v. EPA, 108 F.3d 1397, 1410 (D.C. Cir. 1997) (citing Natural Resources Defense Council, Inc. v. Browner, 57 F.3d 1122, 1123 (D.C. Cir. 1995)) (discussing that states have primary responsibility for determining an emission reductions program for its areas subject to EPA approval).

Thus, neither the status of CAIR (which has now sunset) nor CSAPR (which is being implemented) impacts our decision to approve West Virginia's progress report SIP. This SIP includes an adequate discussion of the implementation of regional haze SIP measures—including CAIR—and of the significant emission reductions achieved.

In addition, EPA disagrees with Commenter that EPA's approval of West Virginia's progress report which relies on CAIR reductions is inconsistent with EPA's prior actions. In fact, EPA has approved redesignations of areas to attainment of the 1997 PM2.5 NAAQS in which states relied on CAIR as an “enforceable measure.” See 77 FR 76415 (December 28, 2012); 78 FR 59841 (September 30, 2013); and 78 FR 56168 (September 12, 2013).

Because EPA expects SO2 and NOX emissions from EGUs to continue through CSAPR and other measures and because future West Virginia regional haze SIP submissions due pursuant to 40 CFR 51.308(f) and (g) will continue to evaluate West Virginia's progress towards natural conditions, EPA believes it is appropriate to approve fully West Virginia's progress report as meeting requirements of 40 CFR 51.308(g)(1)-(7) and (h) at this time. Thus, EPA disagrees with the Commenter that EPA's approval of the West Virginia progress report is inconsistent with EPA's prior position, unsupported by the facts, or arbitrary and capricious as a matter of law.

Further, EPA disagrees with the Commenter's “reiterated” statements concerning the validity of using an emissions trading program, such as CAIR or CSAPR, to meet regional haze requirements such as BART. As EPA's 2012 review of the West Virginia regional haze SIP explains, the State relied on CAIR to achieve significant reductions in emissions to meet both the BART requirements and to address impacts from West Virginia sources in Class I areas. 77 FR 16932. West Virginia's reliance upon CAIR as an alternative to source-specific BART at the time of the submittal of West Virginia's regional haze SIP in 2008 to EPA was supported by precedent from the D.C. Circuit as well as EPA's regulations at 40 CFR 51.308(e). CAIR was specifically upheld as an alternative to BART in accordance with the requirements of section 169A of the CAA by the D.C. Circuit in Utility Air Regulatory Group v. EPA. 471 F.3d 1333 (D.C. Cir. 2006). The D.C. Circuit concluded that the EPA's two-pronged test for determining whether an alternative program achieves greater reasonable progress was a reasonable one and also agreed with EPA that nothing in the CAA required the EPA to “impose a separate technology mandate for sources whose emissions affect Class I areas, rather than piggy-backing on solutions devised under other statutory categories, where such solutions meet the statutory requirements.” Id. at 1340. See also Center for Energy and Economic Development v. EPA, 398 F.3d 653, 660 (D.C. Cir. 2005) (finding reasonable EPA's interpretation of section 169A(b)(2) of the CAA as requiring BART only as necessary to make reasonable progress). Thus, EPA disagrees with the Commenter that EPA cannot use cap-and-trade programs to address effects of sources in Class I areas and disagrees that the use of alternatives to source-specific BART is an impediment to states achieving reasonable progress as required by section 169A of the CAA.

EPA also notes in general that the comments regarding CAIR as adequate for regional haze requirements are beyond the scope of this rulemaking action. In this rulemaking action, EPA is finalizing approval of West Virginia's progress report SIP and did not propose to find that participation in CSAPR or CAIR is an alternative to BART in this rulemaking action. Moreover, EPA did not reopen discussions on the CAIR or CSAPR provisions as they relate to BART in assessing the progress report.10

Finally, EPA also generally disagrees with the Commenter that EPA did not discuss CAIR in EPA's NPR. EPA discussed CAIR, as well as emission reductions from CAIR, when assessing West Virginia's five year progress report as meeting requirements in 40 CFR 51.308(g)(1) and (2). CAIR, as an EGU control strategy, was one measure from West Virginia's regional haze SIP discussed in EPA's analysis of implementation of SIP measures for 40 CFR 51.308(g)(1), and emission reductions of SO2 and NOX from EGUs generally resulting from implementation of CAIR are discussed in EPA's analysis of West Virginia's progress report for 40 CFR 51.308(g)(2). See 79 FR at 11462-11463. In addition, in EPA's SNPR, EPA discussed the litigation history and status of CAIR and CSAPR and the effects of those programs on West Virginia's regional haze SIP in detail and provided an opportunity for comment on these issues. 80 FR at 12609-12611.

In summary, EPA does not view West Virginia's reliance through December 2014 upon CAIR for BART or for any other part of the regional haze SIP as a reason to disapprove the West Virginia progress report.

Comment 5: The Commenter expressed support for the maintenance of the IMPROVE visibility monitoring network. The Commenter stated it would like funding to continue for this monitoring network and would like EPA to advocate for funding of this network. The Commenter also stated its support for continuing funding for VISTAS' work for additional “understanding of source contributions to PM2.5 mass and visibility impairment or continued operation of VISTAS Web site.”

Response 5: EPA thanks the Commenter for expressing its support for the IMPROVE monitoring network and for the work by VISTAS. In its progress report SIP, West Virginia summarized the existing visibility monitoring network at Dolly Sods and Otter Creek and discussed the State's intended continued reliance on the IMPROVE monitoring network for its visibility planning. West Virginia concluded that the existing network is adequate and that no modifications to visibility monitoring strategy were necessary. In EPA's NPR, EPA concluded that West Virginia adequately addressed the sufficiency of its monitoring strategy as required by 40 CFR 51.308(g)(7), and EPA accordingly proposed approval of the West Virginia progress report. Additional funding concerns for VISTAS as raised by the Commenter are beyond the scope of this rulemaking.

Comment 6: The SNPR Commenter stated that EPA's reasons to approve the progress report are sound and stated it supported approval of the progress report SIP. The SNPR Commenter stated that CAIR was in the West Virginia SIP and in effect and enforceable throughout the period relevant to West Virginia's assessment of progress. The SNPR Commenter also agreed with EPA that EPA may consider a FIP as well as a SIP in evaluating a regional haze program under 40 CFR 51.308(g)(6) and (h). Finally, the SNPR Commenter stated EPA had a sound basis to approve the West Virginia progress report SIP based on the status of CAIR and CSAPR and stated reliance on CSAPR for further progress toward applicable RPGs in West Virginia and other affected states was appropriate as CSAPR has taken effect. The SNPR Commenter noted, however, that EPA had no valid basis for its limited disapproval of West Virginia's regional haze SIP based on West Virginia's reliance upon CAIR as a BART alternative.

Response 6: EPA appreciates the supportive comments from the SNPR Commenter and its agreement with EPA's analysis in the NPR and SNPR. The SNPR Commenter's statement regarding EPA's prior limited approval of West Virginia's regional haze SIP is beyond the scope of this rulemaking and therefore no further response is provided.

EPA is approving West Virginia's regional haze five-year progress report SIP revision, submitted on April 30, 2013, as meeting the applicable regional haze requirements as set forth in 40 CFR 51.308(g) and 51.308(h).

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);

• does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);

• is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.);

• does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and

• does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 4, 2015. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action.

This action to approve West Virginia's regional haze five-year progress report SIP revision may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

40 CFR part 52 is amended as follows:

Throughout this document, “we,” “us,” and “our” refer to the EPA.

Table 1 lists the rules addressed by this proposal with the dates that they were adopted by the local air agencies and submitted by the California Air Resources Board.

On September 11, 2014, the EPA determined that the submittal for EKAPCD Rule 432 met the completeness criteria in 40 CFR part 51, appendix V, which must be met before formal EPA review. On December 18, 2014, the EPA determined that the submittal for MDAQMD Rule 464 met the completeness criteria in 40 CFR part 51, appendix V.

There are no previous versions of Rule 432 in the SIP. We approved an earlier version of Rule 464 into the SIP on September 27, 1995 (60 FR 49772).

VOCs help produce ground-level ozone and smog, which harm human health and the environment. Section 110(a) of the CAA requires States to submit regulations that control VOC emissions.

The purpose of Rule 432 is to reduce VOC emissions from polyester resin operations. Rule 432 requires that for open molding processes, operators must use materials that comply with limits specified in Table 1 of the rule. It also sets requirements for non-monomer VOC content and for the use of resins containing a vapor suppressant. Rule 432 requires use of a closed-mold system or installation and operation of a VOC emission control system that meets specific requirements, including an overall capture and control efficiency of at least 90 percent by weight. In addition, the rule sets requirements for touch up, repair, and small jobs, spray application, organic solvents used in cleaning operations, and solvent storage and disposal. Rule 432 provides exemptions for small uses and certain solvent cleaning operations. It includes recordkeeping requirements, test methods, and compliance schedules.

The purpose of Rule 464 is to reduce VOC emissions from oil-water separators. Revised Rule 464 updates the rule's applicability to include additional oil-water separators, specifies cover seal tolerances, updates the required overall control efficiency from 90% to 95%, addresses the processing of oil or tar skimmed from separators, reduces the threshold for fugitive leak violations, clarifies exemptions, extends the recordkeeping requirement to 5 years, and adds test methods.

EPA's technical support documents (TSDs) have more information about these rules.

SIP rules must be enforceable (see CAA section 110(a)(2)), must not interfere with applicable requirements concerning attainment and reasonable further progress or other CAA requirements (see CAA section 110(l)), and must not modify certain SIP control requirements in nonattainment areas without ensuring equivalent or greater emissions reductions (see CAA section 193).

Guidance and policy documents that we use to evaluate enforceability, revision/relaxation and rule stringency requirements for the applicable criteria pollutants include the following:

Generally, SIP rules must require Reasonably Available Control Technology (RACT) for each category of sources covered by a Control Techniques Guidelines (CTG) document as well as each VOC major source in ozone nonattainment areas classified as moderate or above (see sections 182(b)(2) and 182(f)).

The EPA has designated the EKAPCD as a Moderate nonattainment area for the 1997 8-hour ozone standard and as a Marginal nonattainment area for the 2008 8-hour ozone standard. See 40 CFR 81.305. Rule 432 must implement RACT for the 1997 8-hour ozone standard because RACT requirements apply in areas designated as Moderate or above (i.e., or Serious, Severe, or Extreme).

The EPA has designated a portion of the MDAQMD as a Severe nonattainment area for both the 1997 and 2008 8-hour ozone standards. Rule 464 must implement RACT because RACT requirements apply in areas designated as Moderate or above.

We believe these rules are consistent with the relevant policy and guidance regarding enforceability, RACT, and SIP relaxations. The TSDs have more information on our evaluation.

The TSDs describe additional rule revisions that we recommend for the next time the local agencies modify the rules but are not currently the basis for rule disapproval.

As authorized in section 110(k)(3) of the Act, the EPA is fully approving the submitted rules because we believe they fulfill all relevant requirements. We do not think anyone will object to this approval, so we are finalizing it without proposing it in advance. However, in the Proposed Rules section of this Federal Register, we are simultaneously proposing approval of the same submitted rules. If we receive adverse comments by July 6, 2015, we will publish a timely withdrawal in the Federal Register to notify the public that the direct final approval will not take effect and we will address the comments in a subsequent final action based on the proposal. If we do not receive timely adverse comments, the direct final approval will be effective without further notice on August 4, 2015. This will incorporate these rules into the federally enforceable SIP.

Please note that if the EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, the EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment.

In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of the EKAPCD and MDAQMD rules described in the amendments to 40 CFR part 52 set forth below. The EPA has made, and will continue to make, these documents generally available electronically through www.regulations.gov and in hard copy at the appropriate EPA office (see the ADDRESSES section of this preamble for more information).

Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

• does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);

• is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.);

• does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and

• does not provide the EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. The EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 4, 2015. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the Proposed Rules section of this Federal Register, rather than file an immediate petition for judicial review of this direct final rule, so that the EPA can withdraw this direct final rule and address the comment in the proposed rulemaking. This action may not be challenged later in proceedings to enforce its requirements (see section 307(b)(2)).

Part 52, chapter I, title 40 of the Code of Federal Regulations is amended as follows:

I. General Information A. Does this action apply to me?

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

You may access a frequently updated electronic version of 40 CFR part 180 through the Government Publishing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP test guidelines referenced in this document electronically, please go to http://www.epa.gov/ocspp and select “Test Methods and Guidelines.”

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2014-0265 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before August 4, 2015. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2014-0265, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.

• Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html.

Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

In the Federal Register of October 24, 2014 (Vol. 79 FR 63594) (FRL-9916-03), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-10682) by Exponent, Inc., 1150 Connecticut Ave. NW., Suite 1100, Washington, DC 20035 on behalf Huntsman Corp., 8600 Gosling Road, The Woodlands, TX 77381. The petition requested that 40 CFR 180.910, 180.930, and 180.940 be amended by establishing an exemption from the requirement of a tolerance for residues of n-butyl benzoate (CAS Reg. No. 136-60-7) when used as an inert ingredient (solvent) in pesticide formulations applied to growing crops, raw agricultural commodities after harvest, and animals and when used as an inert ingredient in antimicrobial formulations in food-contact surface sanitizer products. That document referenced a summary of the petition prepared by Exponent, Inc., on behalf Huntsman Corp., the petitioner, which is available in the docket, http://www.regulations.gov. No tolerance-related comments were received on the notice of filing.

Based on a review of the data submitted in support of this petition, EPA has modified the exemption requested by limiting the amount of n-butyl benzoate allowed in food contact sanitizing solutions to a maximum 15,000 ppm (1.5%). This limitation is based on the Agency's risk assessment which can be found at http://www.regulations.gov in document “n-Butyl Benzoate; Human Health Risk Assessment and Ecological Effects Assessment to Support Proposed Exemption from the Requirement of a Tolerance When Used as an Inert Ingredient in Pesticide Formulations,” in docket ID number EPA-HQ-OPP-2014-0265.

Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): Solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term “inert” is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients.

Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”

EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be clearly demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.

Consistent with FFDCA section 408(c)(2)(A), and the factors specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for n-butyl benzoate including exposure resulting from the exemption established by this action. EPA's assessment of exposures and risks associated with n-butyl benzoate follows.

EPA has evaluated the available toxicity data and considered their validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the adverse effects caused by n-butyl benzoate as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are discussed in this unit.

In acute oral, dermal, and inhalation toxicity studies in rats, n-butyl benzoate was found to be slightly toxic to nontoxic. In primary eye and dermal irritation studies in rabbits, n-butyl benzoate was found to be minimally irritating. In a dermal sensitization study in guinea pigs, n-butyl benzoate was not a dermal sensitizer.

In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test, n-butyl benzoate was administered daily to rats by gavage at doses of 0 (vehicle control), 250, 500 and 1,000 mg/kg bw/day. The NOAEL for parental toxicity was 1,000 mg/kg/day; the highest dose tested. The LOAEL for parental toxicity was not observed in this study. The NOAEL for embryo-fetal toxicity was 500 mg/kg bw/day based on increased pup mortality on post-natal day zero observed at the LOAEL of 1,000 mg/kg/day.

No positive mutagenic response was observed for n-butyl benzoate in a reverse bacterial mutation assay.

No chronic toxicity data for n-butyl benzoate are available.

There are no cancer studies available for n-butyl benzoate. n-Butyl benzoate is metabolized by esterase mediated hydrolysis resulting in the formation of two major polar metabolites, n-butyl alcohol and benzoic acid. Each metabolite enters other degradation pathways to be rapidly metabolized and/or excreted. Based on predicted rapid metabolism and excretion, the lack of specific target organ toxicity in the OCSPP Harmonized Test Guideline 870.3650 study, the results of genotoxicity testing being negative, and a Quantitative Structure Activity Relationship (QSAR) expert model, DEREK Nexus, that indicates no structural alerts for carcinogenicity, n-butyl benzote is not expected to be carcinogenic.

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.

1. Acute dietary (all populations). There were no adverse effects observed attributable to a single dose for the general population (including infants and children) or females 13-49 years of age.

2. Chronic dietary (all populations). The chronic population adjusted dose (cPAD) of 5 mg/kg/day is established based on the NOAEL of 500 mg/kg/day from a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test in rats. The adverse effects seen in this study were increased pup mortality observed at the LOAEL of 1,000 mg/kg/day. The Food Quality Protection Act (FQPA) safety factor/database uncertainty factor of 1X and 10X intra- and interspecies uncertainty factors are utilized for dietary risk assessment.

3. Dermal, short- and intermediate-term. The level of concern (LOC) for short- and intermediate-term dermal exposure is a margin of exposure (MOE) of 100 and the assessment is based on the NOAEL (500 mg/kg/day) from the combined repeated dose toxicity study with the reproduction/developmental toxicity screening test in rats.

4. Inhalation, short- and intermediate term. The LOC for short- and intermediate-term inhalation exposure is a MOE of 100 and the assessment is based on the NOAEL (500 mg/kg/day) from the combined repeated dose toxicity study with the reproduction/developmental toxicity screening test in rats.

5. Quantification of cancer risk is not appropriate since there are no concerns for cancer based on data that n-butyl benzoate is metabolized by esterase mediated hydrolysis resulting in the formation of two major polar metabolites, n-butyl alcohol and benzoic acid, neither substance being a concern for cancer. In addition, there is a lack of specific target organ toxicity in the OCSPP Harmonized Test Guideline 870.3650 study, the results of genotoxicity testing for n-butyl benzoate are negative, and QSAR expert model, DEREK Nexus, indicates that there are no structural alerts for carcinogenicity. As such, n-butyl benzote is not expected to be carcinogenic.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to n-butyl benzoate, EPA considered exposure under the proposed exemption from the requirement of a tolerance. EPA assessed dietary exposures from n-butyl benzoate in food as follows:

The Agency assessed the dietary exposures to n-butyl benzoate as an inert ingredient for use in pesticide formulations applied to growing crops, raw agricultural commodities, and livestock as well as an inert ingredient for use in food-contact surface sanitizing solutions. In the case of dietary exposures to n-butyl benzoate as an inert ingredient used in pesticide formulations applied to growing crops, raw agricultural commodities, and livestock, a chronic dietary exposure assessment was conducted using the Dietary Exposure Evaluation Model/Food Commodity Intake Database (DEEM-FCID)TM, Version 3.16. EPA used food consumption information from the U.S. Department of Agriculture's National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). This dietary survey was conducted from 2003 to 2008. As to residue levels in food, no residue data were submitted for n-butyl benzoate. In the absence of specific residue data, EPA has developed an approach that uses surrogate information to derive upper bound exposure estimates for the subject inert ingredient. Upper bound exposure estimates are based on the highest tolerance for a given commodity from a list of high-use insecticides, herbicides, and fungicides. A complete description of the general approach taken to assess inert ingredient risks in the absence of residue data is contained in the memorandum entitled “Alkyl Amines Polyalkoxylates (Cluster 4): Acute and Chronic Aggregate (Food and Drinking Water) Dietary Exposure and Risk Assessments for the Inerts.” (D361707, S. Piper, 2/25/09) and can be found at http://www.regulations.gov in docket ID number EPA-HQ-OPP-2008-0738.

In the case of the proposed use of n-butyl benzoate as an inert ingredient in food-contact sanitizing pesticide products, EPA has utilized a conservative, health-protective method of estimating dietary intake that is based upon conservative assumptions related to the amount of residues that can be transferred to foods as a result of the proposed use. This same methodology has been utilized by FDA in estimating dietary exposures to antimicrobial pesticides used in food-handling settings. A complete description of the approach used to assess dietary exposures resulting from food contact sanitizing solution uses of n-butyl benzoate can be found at http://www.regulations.gov in document “n-Butyl Benzoate; Human Health Risk Assessment and Ecological Effects Assessment to Support Proposed Exemption from the Requirement of a Tolerance When Used as an Inert Ingredient in Pesticide Formulations,” pp. 13-15 in docket ID number EPA-HQ-OPP-2014-0265.

The exposures from food and food contact sanitizing are then added together for the final dietary exposure assessment.

2. Dietary exposure from drinking water. For the purpose of the screening level dietary risk assessment to support this request for an exemption from the requirement of a tolerance for n-butyl benzoate, a conservative drinking water concentration value of 100 ppb based on screening level modeling was used to assess the contribution to drinking water for the chronic dietary risk assessments for parent compound. These values were directly entered into the dietary exposure model.

3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., textiles (clothing and diapers), carpets, swimming pools, and hard surface disinfection on walls, floors, tables).

There are no current or proposed residential uses for n-butyl benzoate, however it is possible that n-butyl benzoate may be used as an inert ingredient in pesticide products that may have uses resulting in potential residential exposures. A complete description of the approach used to assess possible residential exposures from n-butyl benzoate can be found at http://www.regulations.gov in document “n-Butyl Benzoate; Human Health Risk Assessment and Ecological Effects Assessment to Support Proposed Exemption from the Requirement of a Tolerance When Used as an Inert Ingredient in Pesticide Formulations,” pp. 16 in docket ID number EPA-HQ-OPP-2014-0265.

4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

EPA has not found n-butyl benzoate to share a common mechanism of toxicity with any other substances, and n-butyl benzoate does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that n-butyl benzoate does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA Safety Factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

2. Prenatal and postnatal sensitivity. There is an evidence of increased susceptibility of infants and children in the OECD 422 study in rats. In this study, the NOAEL for parental toxicity was 1,000 mg/kg/day; the highest dose tested while the NOAEL for embryo-fetal toxicity was 500 mg/kg/day based on increased pup mortality on post-natal day zero seen at the LOAEL of 1,000 mg/kg/day. However, the concern for this susceptibility is low because there is clear NOAEL established in the study protecting the offspring, and regulatory doses were selected to be protective of these effects. No other residual uncertainties were identified with respect to susceptibility. The endpoints and doses selected for the dietary risk assessment of n-butyl benzoate are protective of adverse effects in both offspring and adults.

3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings:

i. The toxicity database for n-butyl benzoate contains acute toxicity, subchronic toxicity, reproductive toxicity, developmental toxicity, and genotoxicity data. No immunotoxicity or neurotoxicity study is available; however, there was no evidence of any triggers for immunotoxicity or neurotoxicity in the database. Therefore, there is no need for immunotoxicity or neurotoxicity study at this time and no need for additional uncertainty factor for the lack of those studies.

ii. Although there is evidence that n-butyl benzoate results in increased susceptibility in the combined repeated dose toxicity study with the reproduction/developmental toxicity screening test in rats, that study identified a clear NOAEL for offspring effects, which the Agency is using as the endpoint for its assessment. Therefore, the concern for these effects is low and there is no need for an additional uncertainty factor.

iii. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100% CT and tolerance-level residues, as well as conservative assumptions for food-contact surface sanitizers. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to n-butyl benzoate in drinking water. These assessments will not underestimate the exposure and risks posed by n-butyl benzoate.

1. Acute risk. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected. Therefore, n-butyl benzoate is not expected to pose an acute risk.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to n-butyl benzoate from food and water will utilize 21.0% of the cPAD for the U.S. population and 94.1% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure.

3. Short- and intermediate-term risk. Short- and intermediate-term aggregate exposure takes into account short- and intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). While n-butyl benzoate is not currently used as an inert ingredient in pesticide products that are registered for uses that could result in short- or intermediate-term residential exposure, it is possible that n-butyl benzoate could be used in such products and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with potential short- and intermediate-term residential exposures to n-butyl benzoate.

Using the exposure assumptions described in this unit for short-and intermediate-term exposures, EPA has concluded the combined food, water, and residential exposures result in aggregate short- and intermediate-term MOEs of 320 for adults and 100 for children (1-2 years old). EPA's level of concern for n-butyl benzoate is a MOE of 100 or below; however these MOEs are not of concern based on the highly conservative assumptions made regarding residential and dietary exposures to n-butyl benzoate as described in Unit IV. Section C.

4. Aggregate cancer risk for U.S. population. Based on data that n-butyl benzoate is metabolized by esterase mediated hydrolysis resulting in the formation of two major polar metabolites, n-butyl alcohol and benzoic acid. Each metabolite enters other degradation pathways to be rapidly metabolized and/or excreted, n-butyl benzoate is not expected to pose a cancer risk to humans.

5. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to n-butyl benzoate residues.

An analytical method for enforcement purposes is not required for n-butyl benzoate in pesticide formulations that include uses on crops for pre- and post-harvest, and on animals, since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation.

An analytical method is also not required for enforcement purposes for n-butyl benzoate on food-contact surfaces in antimicrobial applications since the Agency is not establishing a numerical tolerance for residues of n-butyl benzoate in or on any food commodities. EPA is establishing a limitation on the amount of n-butyl benzoate that may be used in food-contact surface antimicrobial applications. That limitation will be enforced through the pesticide registration process under the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”), 7 U.S.C. 136 et seq. EPA will not register any food-contact surface antimicrobial applications for sale or distribution that contains greater than 15,000 ppm (1.5%) of n-butyl benzoate by weight.

Therefore, exemptions from the requirement of a tolerance are established under 40 CFR 180.910, 180.930, and 180.940(a) for n-butyl benzoate (CAS Reg. No. 136-60-7) when used as an inert ingredient (solvent) in pesticide formulations applied to growing crops, raw agricultural commodities after harvest, and animals, and when used as an inert ingredient in antimicrobial formulations in food-contact surface sanitizer products at a maximum level in the end-use concentration of 15,000 parts per million (ppm).

This action establishes exemptions from the requirement of a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the exemptions in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply.

This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian Tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, 40 CFR chapter I is amended as follows:

I. General Information A. Does this action apply to me?

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

You may access a frequently updated electronic version of 40 CFR part 180 through the Government Publishing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP test guidelines referenced in this document electronically, please go to http://www.epa.gov/ocspp and select “Test Methods and Guidelines.”

Under the Federal Food, Drug, and Cosmetic Act (FFDCA) section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2012-0207 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before August 4, 2015. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2012-0207, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.

• Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html.

Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

In the Federal Register of May 2, 2012, (77 FR 25954) (FRL-9346-1), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 1E7933) by Exponent Inc., 1150 Connecticut Ave. NW., Suite 1100, Washington, DC 20036, on behalf of Ecolab, Inc., 370 N. Wabasha Street, St. Paul, MN 55102. The petition requested that 40 CFR part 180.940(a) be amended by establishing an exemption from the requirement of a tolerance for residues of aluminum sulfate for use as an inert ingredient in antimicrobial pesticide formulations applied to food-contact surfaces in public eating places, dairy-processing equipment, and food-processing equipment and utensils at a maximum end use concentration not to exceed 50 parts per million (ppm). That document referenced a summary of the petition prepared by the petitioner Exponent, Inc., which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.” Section 408(c)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in FFDCA section 408(b)(2)(C), which requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”

EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, EPA determines the toxicity of pesticides. Second, EPA examines exposure to the pesticide through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings.

Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxic effects caused by aluminum sulfate is discussed in this unit.

The acute oral toxicity of aluminum sulfate is low. The acute oral lethal dose (LD)50 in male rats is >5,000 milligram/kilogram (mg/kg). No acute dermal or inhalation toxicity studies are available on aluminum sulfate. It is not a dermal irritant and is minimally irritating to the eyes. No skin sensitization studies are available.

The points of departure (PODs) used for the chronic and short-term risk assessments for aluminum sulfate were based on an Organization for Economic Cooperation and Development (OECD) Guideline 416, 2-generation rat oral reproduction study with aluminum sulfate (equivalent to OCSPP Harmonized Test Guideline 870.3800) in which the lowest-observed-adverse-effect level (LOAEL) was 188 milligram/kilogram/day (mg/kg/day) (equivalent to 37 mg aluminum (Al)/kg/day) based on decreased body weight from pups and parents and delay in vaginal opening. The no-observed-adverse-effect level (NOAEL) was 41 mg/kg/day aluminum sulfate (equivalent to 8.06 mg Al/kg/day.

Apart from the 2-generation rat oral reproduction study described above, limited data are available on aluminum sulfate. However, since ingested aluminum sulfate will readily dissociate in the stomach to aluminum (as will many other aluminum compounds), toxicology data on aluminum compounds as well as aluminum sulfate are considered in determining the acceptability and completeness of the toxicological data relevant to aluminum sulfate.

Aluminum compounds have been evaluated by the Agency for Toxic Substances and Disease Registry (ASTDR, 2008) and as part of the toxicological profile of aluminum, ASTDR notes that “There is a rather extensive database on the oral toxicity of aluminum in animals. These studies clearly identify the nervous system as the most sensitive target of aluminum toxicity and most of the animal studies have focused on neurotoxicity and neurodevelopmental toxicity. Other adverse effects that have been observed in animals orally exposed to aluminum include impaired erythropoiesis in rats exposed to 230 mg Al/kg/day and higher; erythrocyte damage (as evidenced by decreases in hemoglobin, hematocrit, and erythrocyte osmotic fragility, and altered erythrocyte morphology) in rats exposed to 230 mg Al/kg/day and higher; increased susceptibility to infection in mouse dams exposed to 155 mg Al/kg/day; delays in pup maturation following exposure of rats to 53 mg Al/kg/day; and decreases in pup body weight gain in rats and mice exposed to 103 mg Al/kg/day and higher. Oral studies in rats and mice have not found significant histopathological changes in the brain under typical exposure conditions; however, altered myelination was found in the spinal cord of mouse pups exposed to 330 mg Al/kg/day on gestation day 1 through postnatal day 35. Overt signs of neurotoxicity are rarely reported at the doses tested in the available animal studies (≤330mg Al/kg/day for bioavailable aluminum compounds); rather, exposure to these doses is associated with subtle neurological effects detected with neurobehavioral performance tests. Significant alterations in motor function, sensory function, and cognitive function have been detected following exposure to adult or weanling rats and mice or following gestation and/or lactation exposure of rats and mice to aluminum lactate, aluminum nitrate, and aluminum chloride. The most consistently affected performance tests were forelimb and/or hindlimb grip strength, spontaneous motor activity, thermal sensitivity, and startle responsiveness. Significant impairments in cognitive function have been observed in some studies, although this has not been found in other studies even at higher doses. Adverse neurological effects have been observed in rats and mice at doses of 100-200 mg Al/kg/day and neurodevelopmental effects have been observed in rats and mice at doses of 103-330 mg Al/kg/day.”

There are no available carcinogenicity studies with aluminum sulfate; however, in a cancer study with aluminum potassium sulfate, there were no exposure-related increased incidences of tumors, other proliferative lesions, or non-neoplastic lesions in B6C3F1 mice that ingested ≤979 mg Al/kg/day as aluminum potassium sulfate in the diet for 20 months. Based on this information, aluminum sulfate is not expected to be a carcinogen.

Specific information on the studies received and the nature of the adverse effects caused by aluminum sulfate as well as the NOAEL and the LOAEL from the toxicity studies are discussed in “Aluminum Sulfate: Human Health Risk Assessment and Ecological Effects Assessment for Proposed Exemption from the Requirement for a Tolerance When Used as an Inert Ingredient in Antimicrobial Pesticide Formulations Applied to Food-Contact Surfaces” in docket ID number EPA-HQ-OPP-2012-0267.

Once a pesticide's toxicological profile is determined, EPA identifies toxicological POD and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which the NOAEL and the LOAEL are identified. Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a RfD—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.

A summary of the toxicological endpoints for aluminum sulfate used for human risk assessment is discussed below:

Acute Dietary Endpoint. No appropriate endpoint was identified from any of the aluminum sulfate studies in the database, including developmental toxicity studies in the rat. Consequently, EPA determined that there was no basis for selecting a dose and endpoint for an acute POD for the general population or females 13-49 years old.

Chronic Dietary Endpoint. A 2-generation reproduction study of aluminum sulfate in rats was considered critical in establishing the POD for chronic dietary risk assessment. The study supports a NOAEL of 41 mg/kg/day and a LOAEL of 188 mg/kg/day for decreased body weight in parents and pups and a delay in vaginal opening and should be used as the POD for all durations and exposure scenarios. An uncertainty factor (UF) of 100X (10X for interspecies extrapolation and 10X for intraspecies variation) is applied to obtain a chronic reference dose (cRfD) of 0.41 mg/kg/day. The Food Quality Protection Act (FQPA) factor is reduced to 1X. The chronic population adjusted dose (cPAD) is 0.41 mg/kg/day. This cPAD is protective of potential neurotoxicological effects of aluminum compounds.

1. Dietary exposure from food and feed uses. Exposures to aluminum sulfate can occur following ingestion of foods with residues from food-contact surface sanitizing solutions for public eating places, treated dairy- and food-processing equipment and utensils as well as pre-harvest crop uses. In evaluating dietary exposure to aluminum sulfate, EPA considered exposure under the requested exemption from the requirement of a tolerance as well as exposures from existing uses of aluminum sulfate under the extant exemption from the requirement of a tolerance under 40 CFR 180.920. EPA assessed dietary exposures from aluminum sulfate in food as follows:

i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide chemical, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. No such effects were identified in the toxicological studies for aluminum sulfate; therefore, a quantitative acute dietary exposure assessment is unnecessary.

ii. Chronic exposure. The chronic dietary exposure assessment for this inert ingredient utilizes the Dietary Exposure Evaluation Model Food Commodity Intake Database (DEEM-FCID), Version 3.16, EPA, which includes food consumption information from the U.S. Department of Agriculture's National Health and Nutrition Examination Survey, “What We Eat In America”, (NHANES/WWEIA). This dietary survey was conducted from 2003 to 2008. In the absence of actual residue data, the inert ingredient evaluation is based on a highly conservative model that assumes that the residue level of the inert ingredient would be no higher than the highest established tolerance for an active ingredient on a given commodity. Implicit in this assumption is that there would be similar rates of degradation between the active and inert ingredient (if any) and that the concentration of inert ingredient in the scenarios leading to these highest of tolerances would be no higher than the concentration of the active ingredient. The model assumes 100 percent crop treated (PCT) for all crops and that every food eaten by a person each day has tolerance-level residues. A complete description of the general approach taken to assess inert ingredient risks in the absence of residue data is contained in the memorandum entitled “Alkyl Amines Polyalkoxylates (Cluster 4): Acute and Chronic Aggregate (Food and Drinking Water) Dietary Exposure and Risk Assessments for the Inerts” (D361707, S. Piper, 2/25/09) and can be found at http://www.regulations.gov in docket ID number EPA-HQ-OPP-2008-0738.

Additionally, a dietary exposure assessment of aluminum sulfate resulting from the requested use in antimicrobial food-contact surface sanitizing solutions was conservatively assumed that 100% of the diet results from food treated with food-contact surface sanitizers and that 100% of the sanitizing solution is transferred into food. A highly conservative model based on FDA assumptions regarding transfer of food contact sanitizing solution residues to food is utilized.

The dietary exposure values derived from both the conservative model used to estimate residues from application to growing crops are combined with the exposures estimated from the antimicrobial food-contact sanitizer uses.

iii Cancer. Based on the data summarized in Unit III.A., EPA has concluded that aluminum sulfate is not expected to pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary.

2. Dietary exposure from drinking water. For the purpose of the screening level dietary risk assessment to support this request for an exemption from the requirement of a tolerance for aluminum sulfate, a conservative drinking water concentration value of 100 parts per billion (ppb) based on screening level modeling was used to assess the contribution to drinking water for the chronic dietary risk assessment of aluminum sulfate. This value was directly entered into the dietary exposure model.

3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., textiles (clothing and diapers), carpets, swimming pools, and hard surface disinfection on walls, floors, tables).

There are no registered pesticide products containing aluminum sulfate as an inert ingredient for any specific use patterns that would result in residential exposure.

4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

EPA has not found aluminum sulfate to share a common mechanism of toxicity with any other substances, and aluminum sulfate does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that aluminum sulfate does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act Safety Factor (FQPA SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

2. Prenatal and postnatal sensitivity. In a 2-generation reproduction toxicity study, there was no evidence of increased susceptibility of infants and children to aluminum sulfate. In this study, the offspring and parental toxicity NOAEL was 41 mg/kg/day based on decreased weight gain in offspring, decreased body weight in parental animals, and a delay in vaginal opening seen at the LOAEL of 188 mg/kg/day.

3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings:

i. The toxicity database for aluminum sulfate includes a 2-generation reproduction study, as well as chronic/carcinogenicity studies, mutagenicity studies, neurotoxicity studies and developmental neurotoxicity studies on other related aluminum compounds. The Agency concludes that for this ingredient, the results of these studies provide a reliable basis for assessing the range of potential effects to infants and children, such that the Agency has determined that no additional data are necessary at this time to evaluate effects to infants and children.

ii. There are available data on neurotoxicity and developmental neurotoxicity on aluminum compounds. The point of departure selected for risk assessment is based on a 2-generation rat reproductive toxicity study with aluminum sulfate, in which adverse effects were identified at dose levels below the dose levels at which neurotoxic effects or developmental neurotoxicological effects were observed and is therefore protective of those effects; no additional UFs are required to account for neurotoxicity.

iii. There is no evidence of increased susceptibility due to pre-or post-natal exposure to aluminum in infants and children.

iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and residues equivalent to the highest established tolerance-level residues for every food commodity. EPA made conservative (protective) assumptions utilizing a 100 ppb default value in the ground and surface water modeling used to assess exposure to aluminum sulfate in drinking water. In addition, highly conservative assumptions were utilized in assessing exposures to aluminum sulfate resulting from the proposed use in food-contact surface antimicrobial pesticide formulations. These assessments will not underestimate the exposure and risks posed by aluminum sulfate.

EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and cPAD. For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.

1. Acute risk. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified, therefore, an acute dietary exposure assessment was not conducted.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to aluminum sulfate from food and water will utilize 6.7% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure.

3. Short-term and intermediate-term risk. Short-term and intermediate-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). A short-term/intermediate-term adverse effect was identified; however, aluminum sulfate is not used as inert ingredient in any pesticide product registered for any use patterns that would result in short-term or intermediate-term residential exposure. Because there is no short-term or intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess short-term risk), no further assessment of short-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating short-term risk for aluminum sulfate.

4. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in a rodent carcinogenicity study with aluminum potassium sulfate, aluminum sulfate is not expected to pose a cancer risk to humans.

5. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to aluminum sulfate residues.

An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation. EPA is establishing a limitation on the amount of aluminum sulfate that may be used in food-contact surface antimicrobial applications. That limitation will be enforced through the pesticide registration process under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq. EPA will not register any food-contact surface antimicrobial applications for sale or distribution that contains greater than 50 ppm of aluminum sulfate by weight.

Therefore, an exemption is established for residues of aluminum sulfate for use as an inert ingredient in antimicrobial pesticide formulations applied to food-contact surfaces in public eating places, dairy-processing equipment, and food-processing equipment and utensils at a maximum end use concentration not to exceed 50 ppm.

This action establishes an exemption from the requirement of a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the exemption in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply.

This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, 40 CFR chapter I is amended as follows:

The Committee's regulation at 41 CFR 51-6.4, Military Resale Commodities, requires military commissary stores and other military resale outlets to stock certain products in the Committee's program, which are identified by special military resale number series. 41 CFR 51-6.4 references number series 0- (0-99), 200-, 300-, 400-, 500-, 600-, 700-, 800-, 900-, 1000-, 1100-, 1200- (1200-9999), and 10000- (10000-10999), with the 300-800-, 900-, 1000-, 1100-, and 10000- (10000-10999) series being stocked exclusively and all series being stocked in as broad a range as practicable. Additional number series are required because the numbers cannot be re-used after being assigned to a product. The expansion of the number series will not expand the scope of the military resale products, rather it will allow for the effective administration and maintenance of the military resale program at its current level. This final rule adds series 11000 (11000-11999); 12000 (12000-12999); 13000 (13000-13999); 14000 (14000-14999); 15000 (15000-15999); and 16000 (16000-16999) to 41 CFR 51-6.4(b), (c)(2), (c)(4), and (d) to be stocked in as broad a range as practicable.

Executive Order 12866: This agency has made the determination that this rule is not significant for the purposes of EO 12866.

Administrative Procedure Act: The Committee finds under 5 U.S.C. 553(b)(3)(B) that good cause exists to waive prior notice and opportunity for public comment. This final rule simply adds numbers to a series of number that already exist. These series are internal to this agency and have no impact on nonprofit agencies not working in the military resale area. National Industries for the Blind, a central nonprofit agency in the Committee's program, requested these specific number series on behalf of the nonprofit agencies that participate in the military resale arena. The Defense Commissary Agency also asked the Committee to take this action. Since both the Federal and nonprofit agencies requested these number series, it is highly unlikely that there would be any adverse comments on this rule. Because this amendment is not a substantive change to the regulation, it is unnecessary to provide notice and opportunity for public comment. Further, pursuant to 5 U.S.C. 553(b)(3)(A), this rule of agency organization, procedure and practice is not subject to the requirement to provide prior notice and opportunity for public comment. The Committee also finds that the 30-day delay in effectiveness, required under 5 U.S.C. 553(d), is inapplicable because this rule is not a substantive rule. This final rule merely expands the series of item numbers for use in the military resale program.

Regulatory Flexibility Act: Because notice and opportunity for comment are not required pursuant to 5 U.S.C. 553 or any other law, the analytical requirements of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) are inapplicable. Therefore, a regulatory flexibility analysis is not required and has not been prepared.

For the reasons set out in the preamble, the committee amends 41 CFR part 51 as follows:

As the Department received no comments on its interim final rule published on October 2, 2014, we are making no changes to the rule and its effective date is October 2, 2014. For regulatory analyses and notices associated with this action, please see the interim final rule published at 79 FR 59448.

The Atlantic shark fisheries are managed under the 2006 Consolidated HMS Fishery Management Plan (FMP), its amendments, and its implementing regulations (50 CFR part 635) issued under authority of the Magnuson-Stevens Fishery Conservation and Management Act (16 U.S.C. 1801 et seq.).

Under § 635.5(b)(1), dealers must electronically submit reports on sharks that are first received from a vessel on a weekly basis through a NMFS-approved electronic reporting system. Reports must be received by no later than midnight, local time, of the first Tuesday following the end of the reporting week unless the dealer is otherwise notified by NMFS. Under § 635.28(b)(2), the quotas of certain species and/or management groups are linked. The quotas for blacknose sharks and the non-blacknose SCS management group in the Atlantic region are linked (§ 635.28(b)(3)(iii)). Under § 635.28(b)(2), when NMFS calculates that the landings for any species and/or management group of a linked group has reached or is projected to reach 80 percent of the available quota, NMFS will file for publication with the Office of the Federal Register a notice of closure for all of the species and/or management groups in a linked group that will be effective no fewer than 5 days from date of filing. From the effective date and time of the closure until and if NMFS announces, via a notice in the Federal Register, that additional quota is available and the season is reopened, the fisheries for all linked species and/or management groups are closed, even across fishing years.

On December 2, 2014 (79 FR 71331), NMFS announced that the 2015 commercial Atlantic blacknose shark quota is 17.5 metric tons (mt) dressed weight (dw) (38,638 lb dw) and the non-blacknose SCS quota is 176.1 mt dw (388,222 lb dw).

Dealer reports recently received through May 29, 2015, indicated that 16.3 mt dw or 93 percent of the available Atlantic blacknose shark quota had been landed and 86.1 mt dw or 49 percent of the available Atlantic non-blacknose SCS quota had been landed. Based on these dealer reports, landings of Atlantic blacknose sharks have already exceeded 80 percent of the quota. Accordingly, NMFS is closing both the commercial blacknose shark fishery and non-blacknose SCS management group in the Atlantic region as of 11:30 p.m. local time June 7, 2015. The only shark species or management groups that remain open in the Atlantic region are research large coastal sharks, sandbar sharks within the shark research fishery, blue shark, and pelagic sharks other than porbeagle or blue shark management groups. On July 1, 2015, in the Atlantic region, the aggregated large coastal shark and hammerhead shark management groups will open.

At § 635.27(b)(1), the boundary between the Gulf of Mexico region and the Atlantic region is defined as a line beginning on the East Coast of Florida at the mainland at 25°20.4′ N. lat, proceeding due east. Any water and land to the south and west of that boundary is considered, for the purposes of monitoring and setting quotas, to be within the Gulf of Mexico region.

During the closure, retention of blacknose sharks and non-blacknose SCS in the Atlantic region is prohibited for persons fishing aboard vessels issued a commercial shark limited access permit (LAP) under § 635.4. However, persons aboard a commercially permitted vessel that is also properly permitted to operate as a charter vessel or headboat for highly migratory species (HMS) and is engaged in a for-hire trip could fish under the recreational retention limits for sharks and “no sale” provisions (§ 635.22(a) and (c)).

During this closure, a shark dealer issued a permit pursuant to § 635.4 may not purchase or receive blacknose sharks or non-blacknose SCS in the Atlantic region from a vessel issued a shark LAP, except that a permitted shark dealer or processor may possess blacknose sharks and/or non-blacknose SCS in the Atlantic region that were harvested, off-loaded, and sold, traded, or bartered prior to the effective date of the closure and were held in storage consistent with § 635.28(b)(5). Similarly, a shark dealer issued a permit pursuant to § 635.4, in accordance with relevant state regulations, may purchase or receive blacknose sharks and/or non-blacknose SCS in the Atlantic region if the sharks were harvested, off-loaded, and sold, traded, or bartered from a vessel that fishes only in state waters and that has not been issued a shark LAP, HMS Angling permit, or HMS Charter/Headboat permit pursuant to § 635.4.

Pursuant to 5 U.S.C. 553(b)(B), the Assistant Administrator for Fisheries, NOAA (AA), finds that providing prior notice and public comment for this action is impracticable and contrary to the public interest because the fisheries are currently underway and any delay in this action would result in overharvest of the Atlantic blacknose SCS quota and be inconsistent with management requirements and objectives. Similarly, affording prior notice and opportunity for public comment on this action is contrary to the public interest because if the quota is exceeded, the stock may be negatively affected and fishermen ultimately could experience reductions in the available quota and a lack of fishing opportunities in future seasons. For these reasons, the AA also finds good cause to waive the 30-day delay in effective date pursuant to 5 U.S.C. 553(d)(3). This action is required under § 635.28(b)(2) and is exempt from review under Executive Order 12866.