Federal Register Vol. 82, No.235,

I. Discussion

On September 27, 2017 (82 FR 44879), the NRC published a direct final rule amending its spent fuel storage regulations in part 72 of title 10 of the Code of Federal Regulations (10 CFR) by revising the NUHOMS® System listing within the “List of approved spent fuel storage casks” to renew, for an additional 40-year period, the initial certificate and Amendment Nos. 1 through 11 and 13, Revision 1, and Amendment No. 14 of CoC No. 1004. These changes require, among other things, that all future amendments and revisions to this CoC include evaluations of impacts on TLAAs and AMPs to ensure that they remain adequate to timely identify any changes to spent fuel storage cask SSCs within the scope of the renewal.

In the direct final rule, the NRC stated that if no significant adverse comments were received, the direct final rule would become effective on December 11, 2017. The NRC received one comment submission on the companion proposed rule (82 FR 44971). An electronic copy of this submission can be obtained from the Federal Rulemaking Web site, http://www.regulations.gov, by searching for Docket ID NRC-2017-0138. The comment submission also is available in ADAMS under Accession No. ML17303A026. For the reasons discussed in more detail in Section III, “Public Comment Analysis,” of this document, none of the comments contained in the submission are considered significant adverse comments.

The NRC received one comment submission on the proposed rule from FirstEnergy Nuclear Operating Company (FENOC). The submission contained three comments styled as “comment/questions.” As explained in the September 27, 2017, direct final rule, the NRC would withdraw the direct final rule only if it received a “significant adverse comment.” This is a comment where the commenter explains why the rule would be inappropriate, challenges its underlying premise or approach, or shows why it would be ineffective or unacceptable without a change. A comment is adverse and significant if:

(1) The comment opposes the rule and provides a reason sufficient to require a substantive response in a notice-and-comment process. For example, a substantive response is required when:

(a) The comment causes the NRC staff to reevaluate (or reconsider) its position or conduct additional analysis;

(b) The comment raises an issue serious enough to warrant a substantive response to clarify or complete the record; or

(c) The comment raises a relevant issue that was not previously addressed or considered by the NRC staff.

(2) The comment proposes a change or an addition to the rule, and it is apparent that the rule would be ineffective or unacceptable without incorporation of the change or addition; or

(3) The comment causes the NRC staff to make a change (other than editorial) to the rule, CoC, or technical specifications (TSs).

In this instance, the NRC determined that none of the comments submitted on the proposed rule are significant adverse comments. The comments either were already addressed by the NRC staff's safety evaluation report (SER) (ADAMS Accession No. ML17131A121), or did not oppose the rule. The NRC has not made any changes to the direct final rule as a result of the public comments. However, the NRC is taking this opportunity to respond to the comments in an effort to clarify information about the direct final rule. The comments and the NRC's responses follow.

The commenter questioned why the proposed renewal of CoC No. 1004 includes a timeframe of 180 days for each general licensee (GL) to establish and implement its AMP procedures, which is shorter than the timeframe of 300 days that was granted for the renewal of CoC No. 1007. The commenter stated that the 180-day implementation period poses a hardship upon GLs with older spent fuel storage systems.

This comment did not raise an issue that was previously unaddressed by the NRC staff. During its review of the renewal application for CoC No. 1004, the NRC staff considered the appropriate timeframe for implementation of the AMP procedures. As stated in the SER, “[t]he timeframe [of 180 days] in the condition is to ensure operating procedures are developed in a timely manner and is consistent with conditions placed in specific licenses that have been renewed.” Specifically, the 180-day timeframe was successfully used for the renewals of the specific licenses under 10 CFR part 72 for the Prairie Island and Calvert Cliffs Independent Spent Fuel Storage Installations (ISFSIs).

The 180-day timeframe is also consistent with the guidance in NUREG-1927, Rev. 1, “Standard Review Plan for Renewal of Spent Fuel Dry Cask Storage System Licenses and Certificates of Compliance.” The commenter points to a statement in the NUREG that “the development of the infrastructure for AMP implementation generally should be no later than one year,” from the date of renewal; however, this does not preclude a shorter timeframe. The cask vendor, TN Americas LLC (TN), is preparing the AMP procedures for the GLs as an update to TN's Final Safety Analysis Report, and plans to provide these procedures within 90 days after the effective date of the renewal. This will allow at least an additional 90 days for the affected GLs to implement the procedures. Accordingly, the comment has not caused the NRC to reevaluate its position that a timeframe of 180 days is sufficient for AMP implementation.

The comment questions why the AMP implementation timeframe for the renewed NUHOMS® CoC is shorter than that for the renewal of CoC No. 1007 for the EnergySolutionsTM Corporation's VSC-24 Ventilated Storage Cask System (82 FR 31433). During the NRC's review of the CoC No. 1007 renewal application, the cask vendor requested that the NRC consider an implementation timeframe of 300 days instead of 180 days after the effective date of the renewal. In that case, the NRC determined that the additional time for implementation was reasonable because CoC No. 1007 was the first CoC to go through the CoC renewal process for GLs. During its review of the renewal application for CoC No. 1004, the NRC staff was aware that the renewed CoC No. 1007, as the first-of-its-kind GL CoC renewal, included more time for AMP implementation. The staff determined that the special circumstances considered for CoC No. 1007 were not present for CoC No. 1004. Accordingly, this comment does not raise a relevant issue that was not previously addressed or considered by the NRC staff.

This comment does not meet the criteria for consideration as a significant adverse comment. The comment did not cause the NRC staff to reevaluate or reconsider its position or conduct additional analysis. Nor did the comment cause the NRC staff to make any change to the rule, CoC, or TSs. To the extent that the comment can be interpreted as requesting a change to the rule, i.e., a longer timeframe for implementation of the AMP procedures, the comment does not show that the rule would be ineffective or unacceptable without incorporation of the change.

The commenter questioned whether the words “implement these written procedures within 180 days” mean that all required AMP inspections must be performed and the results reported within 180 days.

The answer to the commenter's question is no. Implementing the written procedures does not mean that an affected GL must perform all the SSC inspections required by its AMP and report the results of its inspections within the 180-day implementation period.

This comment does not meet the criteria for consideration as a significant adverse comment. The comment does not oppose the rule, and it did not cause the NRC staff to reevaluate or reconsider its position or conduct additional analysis. Nor did the comment cause the NRC staff to make any change to the rule, CoC, or TSs.

The commenter asked if the language in the revised TSs that “[e]ach general licensee shall have a program to establish, implement, and maintain written procedures . . .” applies to all GLs, including those that have only recently begun loading casks under CoC No. 1004. The commenter further asked if a site that began loading casks in 2014 would be required to have the ISFSI AMP procedure in place after 180 days.

Under the renewed CoC, each GL using NUHOMS® systems will be required to have a program with approved written AMP procedures in place within 180 days after the effective date of the renewal, or 180 days after the 20th anniversary of the loading of the first dry storage system at its site, whichever is later. Thus, if a particular ISFSI has casks that were loaded in 2014, these casks would not be required to have AMP procedures in place until 2034 at the earliest.

This comment does not meet the criteria for consideration as a significant adverse comment. The comment did not oppose the rule, and it did not cause the NRC staff to reevaluate or reconsider its position or conduct additional analysis. Nor did the comment cause the NRC staff to make any change to the rule, CoC, or TSs.

Therefore, because no significant adverse comments were received, this direct final rule will become effective as scheduled on December 11, 2017. The final CoC, TS, and SER can be viewed in ADAMS under Accession No. ML17338A091.

On November 2, 2015, the President signed into law the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (Pub. L. 114-74 section 701 (Nov. 2, 2015)) (2015 Act).1 The 2015 Act amended the Federal Civil Penalties Inflation Adjustment Act of 1990 (28 U.S.C. 2461 note) (1990 Inflation Adjustment Act) to improve the effectiveness of civil monetary penalties and to maintain their deterrent effect. The 2015 Act required agencies to: (1) Adjust the level of civil monetary penalties with an initial “catch-up” adjustment through issuance of an interim final rule (IFR) and (2) make subsequent annual adjustments for inflation. Through the “catch-up” adjustment, agencies were required to adjust the maximum amounts of civil monetary penalties to more accurately reflect inflation rates. The 2015 Act directed the Office of Management and Budget (OMB) to issue guidance to agencies on implementing the initial “catch-up” adjustment. The 2015 Act required that agencies publish their IFRs in the Federal Register no later than July 1, 2016 and that the adjusted amounts were to take effect no later than August 1, 2016.

For the subsequent annual adjustments, the 2015 Act requires agencies to increase the penalty amounts by a cost-of-living adjustment. The 2015 Act directs OMB to provide guidance to agencies each year to assist agencies in making the annual adjustments. The 2015 Act requires agencies to make the annual adjustments no later than January 15 of each year and to publish the adjustments in the Federal Register.

The Department of Homeland Security (DHS) undertook a review of the civil penalties that DHS and its components administer to determine which penalties would need adjustments. On July 1, 2016, DHS published an IFR adjusting the civil monetary penalties with an initial “catch-up” adjustment, as required by the 2015 Act. See 81 FR 42987. DHS calculated the adjusted penalties based upon nondiscretionary provisions in the 2015 Act and upon guidance issued by OMB on February 24, 2016.2 The adjusted penalties were effective for civil penalties assessed after August 1, 2016 (the effective date of the IFR) whose associated violations occurred after November 2, 2015 (the date of enactment of the 2015 Act).3 On January 27, 2017, DHS published a final rule adopting as final the civil monetary penalty adjustment methodology from the IFR and making the 2017 annual inflation adjustment pursuant to the 2015 Act and upon guidance OMB issued to agencies on December 16, 2016.4 See 82 FR 8571.

As discussed in Section II below, three civil monetary penalties assessed by CBP and subject to the 2015 Act were inadvertently omitted from these DHS rulemakings.

CBP assesses or enforces penalties under various titles of the Unites States Code (U.S.C.) and the Code of Federal Regulations (CFR). These penalties include civil monetary penalties for certain violations of title 8 of the CFR pursuant to the Immigration and Nationality Act of 1952,5 as well as certain civil monetary penalties for customs violations for laws codified in title 19 of the U.S.C. and the CFR. CBP assesses many of the title 19 penalties under the Tariff Act of 1930, as amended, and as discussed in the IFR preamble at 81 FR 42987, the 2015 Act specifically exempts Tariff Act penalties from the inflation adjustment requirements in the 2015 Act. For that reason, DHS did not list those penalties in the tables of CBP penalty adjustments in the DHS rulemakings. There are also various other monetary penalties found throughout the U.S.C. and CFR which CBP may seek to issue or enforce but which were not included in the tables because they fall within the purview of another Department or Agency for purposes of the 2015 Act.6

However, three non-Tariff Act penalties that are assessed by CBP were inadvertently omitted from the DHS rulemakings. The first is a penalty set forth at 19 U.S.C. 469, and not reflected in the CBP regulations, for dealing in or using already used empty stamped imported liquor containers. The other two penalties are set forth in title 46 of the U.S.C., 46 U.S.C. 55103 and 46 U.S.C. 55111 and reflected in the CBP regulations in 19 CFR part 4. Pursuant to 46 U.S.C. 55103(b) and 19 CFR 4.80(b)(2), CBP assesses penalties for transporting passengers between coastwise points in the United States by a non-coastwise qualified vessel. Pursuant to 46 U.S.C. 55111(c) and 19 CFR 4.92, CBP assesses penalties for towing a vessel between coastwise points in the United States by a non-coastwise qualified vessel.

This final rule adjusts these penalty amounts using the same civil monetary penalty adjustment methodology that DHS announced in the IFR (81 FR 42987) and finalized in the DHS final rule (82 FR 8571), and detailed below.

The 2015 Act provides a new method for calculating inflation adjustments. The new method differs substantially from the methods that agencies used in the past when conducting inflation adjustments pursuant to the 1990 Inflation Adjustment Act. The new method is intended to more accurately reflect inflation. Previously, when agencies conducted adjustments to civil penalties, they did so under rules that required significant rounding of figures. For example, an agency would round a penalty increase that was greater than $1,000, but less than or equal to $10,000, to the nearest multiple of $1,000. While this allowed penalties to be kept at round numbers, it meant that agencies would often not increase penalties at all if the inflation factor was not large enough. Furthermore, increases to penalties were capped at 10 percent, which meant that longer periods without an inflation adjustment could cause a penalty to rapidly lose value in real terms. Over time, the formula used in the 1990 Inflation Adjustment Act calculations frequently caused penalties to lose value relative to actual inflation. The 2015 Act removed these rounding rules, and instead instructs agencies to round penalties to the nearest $1. While this creates penalty values that are no longer round numbers, it does ensure that agencies will increase penalties each year to a figure commensurate with the actual calculated inflation.

To better reflect the original impact of civil penalties, the 2015 Act “resets” the inflation calculations by excluding prior inflationary adjustments under the Inflation Adjustment Act. To do this, the 2015 Act requires agencies to identify, for each penalty, the year that Congress originally enacted the maximum penalty level/range of minimum and maximum penalty levels or the year that the agency last adjusted the penalty amount other than to pursuant to the Inflation Adjustment Act, and the corresponding penalty amount(s). The 2015 Act then requires agencies to perform an initial “catch-up” adjustment, using the original amounts of civil penalties as a baseline, so that the 2016 penalty levels are equal, in real terms, to the penalty amounts as they were originally established. The 2015 Act also requires agencies to make subsequent annual adjustments to increase the penalty amounts by a cost-of-living adjustment.

This section sets forth the initial “catch-up” adjustment for three civil monetary penalties assessed by CBP that were inadvertently omitted from the DHS rulemakings. The catch-up adjustments for these three penalties are listed in Table 1 below. This table shows how DHS would have initially increased the penalties pursuant to the 2015 Act. The table contains the following information:

• In the first column (penalty name), we provide a description of the penalty.

• In the second column (citation), we provide the statutory cite from the United States Code (U.S.C.) and the regulatory cite from the Code of Federal Regulations (CFR).

• In the third column (current penalty), we list the existing penalty in effect on November 2, 2015.

• In the fourth column (baseline penalty (year)), we provide the amount and year of the penalty as enacted by Congress or as last changed through a mechanism other than pursuant to the Inflation Adjustment Act, whichever is later.

• In the fifth column (2016 multiplier), we list the multiplier used to adjust the penalty pursuant to the initial OMB catch-up guidance. The multiplier is determined by the year of enactment or last adjustment of the penalty. The multiplier is based upon the Consumer Price Index (CPI-U) for the month of October 2015, not seasonally adjusted.

• In the sixth column (preliminary new penalty), we list the amount obtained by multiplying the Baseline Penalty from column 4 with the Multiplier from column 5. This amount will be the catch-up adjustment amount, if, in accordance with the 2015 Act, this level does not increase penalty levels by more than 150 percent of the corresponding levels in effect on November 2, 2015.

• In the seventh column (adjusted 2016 penalty), we provide the number for the penalty as it would have been adjusted for 2016. To derive this number, we compare the preliminary new penalty with the current penalty from column 3. The adjusted new penalty is the lesser of either the preliminary new penalty or an amount equal to 150 percent more than the current penalty.

This final rule also makes the 2017 annual inflation adjustment pursuant to the 2015 Act and the guidance OMB issued to agencies on December 16, 2016.7 Pursuant to 28 U.S.C. 2461 note sec. 6, as amended by the 2015 Act, the penalty amounts adjusted by this final rule will be applicable for penalties assessed after December 8, 2017 where the associated violation occurred after November 2, 2015 (i.e., the date the 2015 Act was signed into law). Consistent with OMB guidance, the 2015 Act does not change previously assessed penalties that the agency is actively collecting or has collected.

In Table 2 below, we show: (1) The civil penalty (or penalties) name, (2) the penalty statutory and/or regulatory citation, (3) the penalty amount as it would have been adjusted in 2016 (see Table 1), (4) the cost-of-living adjustment multiplier for 2017 that OMB provided in its December 16, 2016 guidance, and (5) the new 2017 adjusted penalty.

Additionally, we have made conforming edits to the regulatory text for the new adjusted penalty amounts in 19 CFR 4.80(b)(2) and 19 CFR 4.92. Because the 19 U.S.C. 469 penalty is not included in the CFR, there are no conforming edits to be made to the regulatory text. However, this penalty is listed in Table 2 for informational purposes.

The Administrative Procedure Act (APA) generally requires agencies to publish a notice of proposed rulemaking in the Federal Register (5 U.S.C. 553(b)) and to provide interested persons with the opportunity to submit comments (5 U.S.C. 553(c)). The APA also requires agencies to provide a delayed effective date (of not less than 30 days) for substantive rules. 5 U.S.C. 553(d). The 2015 Act, however, specifically instructed that agencies are to make the required annual adjustments notwithstanding section 553 of title 5, United States Code.

DHS is promulgating this final rule to ensure that the amount of civil penalties that CBP assesses or enforces that was inadvertently omitted from the DHS rulemakings reflects the statutorily mandated ranges as adjusted for inflation. The 2015 Act provides a clear nondiscretionary formula for adjustment of the civil penalties; DHS and CBP have been charged only with performing ministerial computations to determine the amounts of adjustments for inflation to civil monetary penalties. Additionally, although the 2015 Act requires publication of an IFR to take effect not later than August 1, 2016, that date has passed and publishing a separate IFR to account for these inadvertently omitted penalty adjustments would cause unnecessary delay. Further, this final rule merely applies the adjustment methodology that DHS provided for public comment in the 2016 IFR and finalized in the 2017 final rule. DHS finds that it is unnecessary to seek further public comment regarding the application of the finalized methodology to these three penalties. For these reasons, and as specified in the 2015 Act, DHS finds good cause to promulgate these CBP civil monetary penalty adjustments as a final rule and finds that the prior public notice-and-comment procedures and delayed effective date requirements of the APA are unnecessary and do not apply to this rule.

As described in Section I above, the 2015 Act requires agencies to make annual adjustments to civil monetary penalties no later than January 15 of each year and to publish the adjustments in the Federal Register. DHS will make future annual inflation adjustments required pursuant to the 2015 Act by final rule notwithstanding the notice-and-comment and delayed effective date requirements of the APA, as required by the 2015 Act. For future annual adjustments, DHS will update the penalty amounts by applying a cost-of-living adjustment multiplier pursuant to OMB guidance. DHS will publish a final rule that provides a table with the adjusted penalty amounts and that updates the numbers in the regulatory text accordingly. DHS will incorporate the three CBP penalties adjusted in this final rule into such future annual adjustment final rules.

Executive Orders 12866 (“Regulatory Planning and Review”) and 13563 (“Improving Regulation and Regulatory Review”) direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. Executive Order 13771 (“Reducing Regulation and Controlling Regulatory Costs”) directs agencies to reduce regulation and control regulatory costs and provides that “for every one new regulation issued, at least two prior regulations be identified for elimination, and that the cost of planned regulations be prudently managed and controlled through a budgeting process.”

OMB has not designated this rule a significant regulatory action under section 3(f) of Executive Order 12866. Accordingly, OMB has not reviewed it. As this rule is not a significant regulatory action it is not subject to the requirements of Executive Order 13771. See OMB's Memorandum, “Guidance Implementing Executive Order 13771, Titled `Reducing Regulation and Controlling Regulatory Costs'” (April 5, 2017) at Q2.

This final rule makes nondiscretionary adjustments to existing civil monetary penalties in accordance with the 2015 Act and OMB guidance.8 DHS therefore did not consider alternatives and does not have the flexibility to alter the adjustments of the civil monetary penalty amounts as provided in this rule. To the extent this final rule increases civil monetary penalties, it would result in an increase in transfers from persons or entities assessed a civil monetary penalty to the government.

The Regulatory Flexibility Act applies only to rules for which an agency publishes a notice of proposed rulemaking pursuant to 5 U.S.C. 553(b). See 5 U.S.C. 601-612. The Regulatory Flexibility Act does not apply to this final rule because a notice of proposed rulemaking was not required for the reasons stated above.

The Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1531-1538, requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or Tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. This final rule will not result in such an expenditure.

The provisions of the Paperwork Reduction Act of 1995, 44 U.S.C. chapter 35, and its implementing regulations, 5 CFR part 1320, do not apply to this final rule, because this final rule does not trigger any new or revised recordkeeping or reporting.

The signing authority for this document falls under 19 CFR 0.2(a). Accordingly, this document is signed by the Secretary of Homeland Security.

For the reasons stated in the preamble, CBP amends 19 CFR p art 4 as follows:

On November 13, 2001, President George W. Bush issued the Military Order titled “Detention, Treatment, and Trial of Certain Non-Citizens in the War Against Terrorism,” which authorized the use of military commissions to try certain terror suspects for war crimes. Pursuant to section 4 of that order, the Secretary of Defense issued policies and procedures for the conduct of those proceedings, which were codified at 32 CFR chapter I, subchapter B. In 2006, the Supreme Court essentially invalidated that military commissions process. Congress subsequently passed several laws reshaping and reauthorizing the use of military commissions, which required the Secretary of Defense to issue new policies and procedures. These updated directives are publicly available and posted to a department Web site. Accordingly, this subchapter, which contains eleven parts, is outdated, no longer in force, and should be removed from the Code of Federal Regulations.

It has been determined that publication of this CFR subchapter removal for public comment is impracticable, unnecessary, and contrary to public interest because it is based on removing outdated policies and procedures.

As this repeal removes information that is now obsolete from the CFR, there is no cost savings to the public for the repeal of this subchapter.

San Joaquin County Department of Public Works has requested a temporary change to the operation of the San Joaquin County (Bacon Island Road) highway Drawbridge over the Middle River, mile 8.6, between Bacon Island and Lower Jones Tract, CA. The drawbridge navigation span provides a vertical clearance of 8 feet above Mean High Water in the closed-to-navigation position. The draw operates as required by 33 CFR 117.171(a). Navigation on the waterway is commercial and recreational.

The drawspan will be secured in the closed-to-navigation position from 6 a.m. on December 18, 2017 through 6 p.m. on December 22, 2017, to allow the bridge owner to make emergency structural repairs. This temporary deviation has been coordinated with the waterway users. No objections to the proposed temporary deviation were raised.

Vessels able to pass through the bridge in the closed position may do so at anytime. In the event of an emergency the draw can open if at least 12 hours advance notice is given to the bridge operator. Old River can be used as an alternate route for vessels unable to pass through the bridge in the closed position. The Coast Guard will also inform the users of the waterway through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessel operators can arrange their transits to minimize any impact caused by the temporary deviation.

In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.

I. Table of Abbreviations

CFR Code of Federal Regulations

DHS Department of Homeland Security

FR Federal Register

NPRM Notice of proposed rulemaking

§  Section

U.S.C. United States Code

COTP Captain of the Port

The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because insufficient time remains to publish an NPRM and to receive public comments, as Hurricane Irma has already caused significant damage to vessels and property in the Sector Key West COTP Zone leaving underwater debris and sunken vessels around the Florida Keys. The safety zone is necessary to provide for the safety of persons, vessels, and property from the hazards posed by sunken vessels and debris. For those reasons, it would be impracticable and contrary to the public interest to publish an NPRM.

On October 12, 2017, the Coast Guard published a temporary interim final rule, entitled “Safety Zone; Sector Key West COTP Zone Post Storm Recovery, Atlantic Ocean, FL” in the Federal Register (82 FR 473474) establishing a temporary safety zone around salvage or pollution removal vessels in the Florida Keys. The Coast Guard solicited for comments for this interim final rule, the comment period for this rule ended on November 13, 2017, no comments were received. The safety zone expires on December 1, 2017, but additional time is needed to complete the salvage and pollution recovery operations. This rule establishes a safety zone from December 1, 2017 to February 1, 2018 to ensure, to the extent practicable, that there continues to be protections for the safety of persons, vessels, and property due to the large volume of debris, sunken vessels and salvage operations associated with Hurricane Irma, which was unable to be completed during the original time frame. It would be impracticable and contrary to the public interest for the existing safety zone to lapse when the salvage and pollution recovery operations need to continue past the expiration date of the existing safety zone.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making it effective less than 30 days after publication in the Federal Register. Any delay in the effective date of this rule would be contrary to the public interest because immediate action is needed to respond to the potential hazards associated with hurricane debris.

The Coast Guard is soliciting public comments on this temporary interim rule. Although we need to make this interim rule effective immediately, we will consider public comments and may issue a temporary final rule that will supersede this interim rule based on comments received.

We view public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.

We encourage you to submit comments through the Federal eRulemaking Portal at http://www.regulations.gov. If your material cannot be submitted using http://www.regulations.gov, contact the person in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions.

We accept anonymous comments. All comments received will be posted without change to http://www.regulations.gov and will include any personal information you have provided. For more about privacy and the docket, visit http://www.regulations.gov/privacyNotice. Documents mentioned in this rule as being available in the docket, and all public comments, will be in our online docket at http://www.regulations.gov and can be viewed by following that Web site's instructions. Additionally, if you go to the online docket and sign up for email alerts, you will be notified when comments are posted or a final rule is published.

The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231 The COTP Key West has determined that potential hazards associated with salvage operations and hurricane debris will be a safety concern for persons, vessels, and property within the waters of the ports mentioned above. The COTP Key West has determined it is necessary establish a safety zone from December 1, 2017 until February 1, 2018, to protect persons, vessels, and property on the navigable waters within the safety zone while cleanup efforts are underway.

This rule establishes a temporary safety zone for certain waters within the Sector Key West Captain of the Port (COTP) Zone as salvage and pollution recovery cleanup efforts continue. Vessels are prohibited from entering into, anchoring, loitering, or movement within a safety zone around salvage or pollution removal vessels in the Florida Keys. These temporary regulations are necessary for the safety of persons, vessels, and property due to the large volume of debris, sunken vessels and salvage operations associated with Hurricane Irma.

The COTP Key West will continue to evaluate conditions in the waters in the vicinity of the Florida Keys and may stop enforcing this rule earlier if the conditions permit. The Coast Guard will provide notification of the safety zone to the local maritime community by Marine Safety Information Bulletins, Broadcast Notice to Mariners, and on-scene designated representatives.

We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.

This regulatory action determination is based on the following reasons: The safety zone is of a small diameter around salvage and pollution recovery vessels and wreckage, and the Coast Guard will provide notice of the safety zones to the local maritime community by Marine Safety Information Bulletins, Broadcast Notice to Mariners, and designated on-scene representatives.

The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section VI.A above, this rule will not have a significant economic impact on any vessel owner or operator.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect 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. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.

Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section above.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone from which vessels are excluded. This rule is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES.

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:

I. Table of Abbreviations CFR Code of Federal Regulations COTP Captain of the Port Sector Ohio Valley DHS Department of Homeland Security FR Federal Register NPRM Notice of proposed rulemaking §  Section U.S.C. United States Code II. Background Information and Regulatory History

The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because impracticable.

We must establish this safety zone by December 4, 2017 and lack sufficient time to provide responsible comment period and then consider those comments before issuing the rule.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register. Delaying the effective date to provide a full 30 days' notice is contrary to public interest because immediate action is needed to protect persons and vessels from safety hazards associated with the Ironton-Russell Bridge demolition.

The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The Captain of the Port Sector Ohio Valley (COTP) has determined that potential hazards associated with the bridge demolition taking place on or over this section of the navigable waterway will be a safety concern for anyone within the area designated as the safety zone. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone during the bridge demolition.

This rule establishes a temporary safety zone from 10 a.m. on December 4, 2017 through 3 p.m. on December 22, 2017 for all navigable waters of the Ohio River from mile marker (MM) 326.5 to MM 327.5, for the Ironton-Russell Bridge demolition in Ironton, OH. This rule will be enforced on from 10 a.m. to 3 p.m. on December 4, 2017, unless the demolition is postponed because of adverse weather, in which case this rule will be enforced from 10 a.m. to 3 p.m. on December 5, 2017, December 11-15, 2017, and December 18-22, 2017.

All potential work delay dates are necessary due to inclement weather, river conditions or mechanical issues that could occur preventing the scheduled demolition on December 4, 2017. The waterway users have been briefed on the procedures to be taken in the event of inclement weather or mechanical issues, and are aware that the project dates may be changed. This safety zone is intended to protect personnel, vessels, and the marine environment in these navigable waters during the bridge demolition. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative.

We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.

This regulatory action determination is based on the size, location, duration, and time-of-year of the safety zone. Vessel traffic will not be able to safely transit through this safety zone, which will impact a small designated area of the Ohio River from MM 326.5 through MM 327.5 for five hours on December 4, 2017, during a time of year when vessel traffic is normally low. Moreover, the Coast Guard will issue Broadcast Notice to Mariners via VHF-FM marine channel 16 about the zone, and the rule allows vessels to seek permission to enter the zone.

The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect 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. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.

Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section above.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone lasting only five hours that will prohibit entry on one day, with alternate work delay dates, that will prohibit entry within MM 326.5 through MM 327.5 on the Ohio River due to demolition project of the Ironton-Russell Bridge. It is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES.

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:

On April 20, 2016, VA published in the Federal Register (81 FR 23228) a proposed rule to amend its regulation at 38 CFR 3.321(b)(1) in order to clarify its long-standing interpretation that the regulation provides an extra-schedular evaluation for a single service-connected disability, and not for the combined effect of two or more service-connected disabilities. Section 501 of title 38, United States Code, provides VA with the authority to interpret its own regulations under its general rulemaking authority. Menegassi v. Shinseki, 638 F.3d 1379, 1382 (Fed. Cir. 2011). VA had already proposed to clarify section 3.321(b)(1) as part of a regulation rewrite project in 2013; however, a subsequent decision by the Federal Circuit held that section 3.321(b)(1) required VA to consider the combined effects of two or more service-connected disabilities when determining extra-schedular evaluations. Johnson v. McDonald, 762 F.3d 1362, 1365-66 (Fed. Cir. 2014), rev'g 26 Vet. App. 237 (2013). This decision conflicts with VA's longstanding interpretation of section 3.321(b)(1), and VA therefore decided to amend the regulation in a separate rulemaking to clarify its interpretation of the regulation.

Interested persons were invited to submit comments to the proposed rule on or before June 20, 2016, and 11 comments were received. Those comments have been organized according to topic in the discussion below.

A commenter stated that VA's rulemaking to overturn Johnson is a violation of the constitutional doctrines of separation of powers and due process. We disagree. “A court's prior judicial construction of a statute trumps an agency construction . . . if the prior court decision holds that its construction follows from the unambiguous terms of the statute and thus leaves no room for agency discretion.” National Cable & Telecomms. Ass'n v. Brand X Internet Servs., 545 U.S. 967, 982 (2005). The Federal Circuit, however, held in Johnson that the language of prior 38 CFR 3.321(b)(1), not a statute, was “unambiguous” and “consistent with language of [38 U.S.C.] § 1155 authorizing the regulation.” 762 F.3d at 1365-66. Where a court decision is based on interpretation of an agency regulation, the agency may undertake rulemaking to revise the regulation to change or clarify the intended meaning of the regulation. See National Org. Veterans' Advocates, Inc. v. Secretary of Veterans Affairs, 260 F.3d 1365, 1374 (Fed. Cir. 2001). Section 1155 of title 38, United States Code, authorizes VA to “adopt and apply a schedule of ratings of reductions in earning capacity from specific injuries or combination of injuries . . . based, as far as practicable, upon the average impairments of earning capacity . . . in civil occupations.” The statute does not mention an extra-schedular evaluation, but rather leaves it to VA's discretion to determine when it is not practicable to assign a rating based upon loss in average earning capacity, and 38 CFR 3.321(b)(1) explains when VA will do so. We therefore do not believe that amendment of the regulation violates separation of powers or due process.

Four commenters stated that amended section 3.321(b)(1) contradicts 38 U.S.C. 1155. One commenter stated that, by limiting an extra-schedular evaluation to an individual rating, an adjudicator is barred from considering a veteran's average earning impairment resulting from a veteran's “injuries” and instead must look to the impairment of each injury. Another commenter stated that the amended rule would render the term “combination of injuries” in section 1155 superfluous. A third commenter stated that the regulation is inconsistent with the plain language of the statute because it applies to a single disability and as a result, the rule will have no controlling weight. The fourth commenter stated that the regulation should compensate for “average impairments of earning capacity” as provided in section 1155 rather than “actual impairment of earning capacity” as provided in amended section 3.321(b)(1).

The rule does not contradict or misinterpret 38 U.S.C. 1155. As explained above, section 1155 authorizes VA to “adopt and apply a schedule of ratings of reductions in earning capacity from specific injuries or combination of injuries. The ratings shall be based, as far as practicable, upon the average impairments of earning capacity . . . in civil occupations.” VA has specified how its rating schedule will be applied to determine average impairments in earning capacity due to combinations of injuries. Under the table in 38 CFR 4.25, the ratings for each disability which are based upon the average earning impairment are combined and a rating is assigned for the combined effect of the disabilities. Thus, the terms “injuries” and “combination of injuries” in section 1155 are not rendered superfluous as a result of revised section 3.321(b)(1). Further, section 1155 states that “ratings shall be based, as far as practicable, upon the average impairments of earning capacity.” VA's rule provides for discretion in cases where the schedule is inadequate to compensate for average impairment of earning capacity. Therefore, the regulation is not inconsistent with the statute.

We disagree with the comment that section 3.321(b)(1) must compensate for impairment of “average earning capacity.” Rather, as the commenter acknowledges, an extra-schedular evaluation is intended for “the exceptional case where the schedular evaluation,” which is based on average earning capacity, “is inadequate.” Section 1155 states that the rating schedule is to be “based, as far as practicable, upon the average impairments of earning capacity.” By its terms, the statute leaves to VA's discretion situations where use of a schedule based on average impairments is not practical or feasible. Pursuant to this authority, VA has promulgated section 3.321(b)(1) allowing for an extra-schedular evaluation in cases in which application of the regular schedular standards is impractical because the veteran's disability is so exceptional or unusual due to such related factors as marked interference with employment or frequent periods of hospitalization. In clarifying its longstanding policy in the amended regulation, VA will continue to look to the evidence to determine whether the veteran's service-connected disability causes factors such as marked interference with employment or frequent periods of hospitalization, rather than limiting a veteran to a schedular rating based upon average impairment of earning capacity.

Another commenter stated that the regulation is inconsistent with the congressionally mandated statutory scheme, which is pro-veteran. As explained above, by its terms, 38 U.S.C. 1155 leaves to VA's discretion situations where use of a schedule based on average impairments is not practicable or feasible, i.e., where applying such a schedule would not result in a rating reflective of the true measure of disability. Because 38 CFR 3.321(b)(1) allows for an extra-schedular evaluation in cases where the disability is “so exceptional or unusual due to such related factors as marked interference with employment or frequent periods of hospitalization” as to render impractical the application of the regular schedular standards, we believe that the rule is consistent with title 38, United States Code, and is pro-veteran.

As explained in the notice of proposed rulemaking, 81 FR at 23230, VA has limited extra-schedular consideration to individual disabilities in part due to the substantial difficulty that would accompany efforts to apply such consideration to the combined effects of multiple disabilities in a logical and consistent manner. A determination as to whether existing rating-schedule provisions are inadequate to evaluate a particular claimant's disability requires comparison of the manifestations of the claimant's disability with the types of manifestations listed in the applicable rating schedule provisions. Ratings for combinations of disabilities are determined by application of a standard formula in 38 CFR 4.25, and there are thus no provisions in the rating schedule describing impairments that would be associated with a particular combination of disabilities. Accordingly, VA adjudicators would have no objective standard for determining whether a particular combined rating is adequate or inadequate. Requiring adjudicators to consider the adequacy of combined ratings would lead to inconsistent and highly subjective determinations, and would likely cause delays in the adjudication of claims. These effects would in some respects be detrimental to claimants and to the effective operation of VA's claims-adjudication system.

One commenter disputed VA's statement in the notice of proposed rulemaking that the Department has long interpreted 38 CFR 3.321(b)(1) to provide an extra-schedular evaluation for only one service-connected disability. The commenter cited to the dissenting opinion in the Veterans Court's Johnson decision, 26 Vet. App. at 257-58, regarding the regulatory language over time. 81 FR 23278.

We respectfully disagree with the analysis of VA's interpretation of the regulation over time. As we stated in the notice of proposed rulemaking, VA, since 1936, has interpreted section 3.321(b)(1) to provide for an extra-schedular evaluation for each service-connected disability for which the schedular evaluation is inadequate based upon the regulatory criteria. The original rule which was promulgated in 1930, R & PR 1307(B), required that a recommendation from a field office alleging that the rating schedule provides inadequate or excessive ratings in an individual case include a statement of findings regarding the extent to which a veteran's actual reduction in earning capacity “is due to the service-connected disability.” The regulation includes only the single version of the word “disability.” The 1936 version of the rule, R & PR 1142, required a submitting agency to provide a recommendation “concerning service connection and evaluation of every disability, under . . . the applicable schedules as interpreted by the submitting agency.” This sentence was deleted from the regulation in 1954, but was incorporated in the Department of Veterans Benefits Veterans Administration Manual 8-5 Revised, para. 47.j. (Jan. 6, 1958), to provide instruction for cases referred under VA Regulation 1142. The word “every” means “[a]ll of a whole collection or aggregate number, considered separately, one by one; each, considered as a unitary part of an aggregate number.” Every, Ballentine's Law Dictionary (emphasis added). Thus, for 28 years following promulgation of R & PR 1307(B) and (C), the VA predecessor regulations to 38 CFR 3.321(b)(1) and the Manual provided for an extra-schedular evaluation based upon the effects of a “disability,” not disabilities.

The Federal Circuit has previously recognized that VA's interpretation of section 3.321(b)(1) is found in the VBA Manual. Thun v. Shinseki, 572 F.3d 1366, 1369 (Fed. Cir. 2009). As explained above, the 1958 Manual M8-5 Revised, para. 47.j., instructed that every claims folder forwarded for extra-schedular consideration “will include a definite recommendation from the submitting agency concerning evaluation of every disability under the schedule as interpreted by the submitting agency with the diagnostic code.” In 1992, VBA revised the VBA Manual by adding the word “individual” before the word “disability(ies)” in paragraph 3.09, Submission For Extra-Schedular Consideration. M21-1, Part VI, para. 3.09 (Mar. 17, 1992), which required preparation of a memorandum to be submitted to Central Office “whenever the schedular evaluations are considered to be inadequate for an individual disability(ies).” Thus, we believe that there is ample support for the statement that VA has long-interpreted section 3.321(b)(1) and its predecessors as providing for an extra-schedular evaluation for a single service-connected disability that was not adequately compensated under the rating schedule.

Two commenters pointed out that section 3.321(b)(1) is intended “[t]o accord justice,” and that the proposed rule is unjust and inequitable because it ignores the cumulative effects of multiple conditions on a veteran's earning capacity. See Johnson, 762 F.3d at 1366. Another commenter stated that proposed section 3.321(b)(1) ignores the fact that a veteran may have multiple service-connected disabilities that combine to limit the veteran's ability to work or that combine to generate an actual condition worse than that contemplated by the disability schedule.

The commenters mistakenly assume that VA may only “accord justice” if all service-connected disabilities are considered collectively for deciding entitlement to an extra-schedular evaluation. There is no dispute that 3.321(b)(1) accords justice by authorizing extra-schedular ratings based upon the effect of a service-connected disability upon an individual veteran rather than limiting the veteran to a schedular rating based upon average impairment of earning capacity. Also, the phrase “[t]o accord justice” is given context in section 3.321(b)(1) by the sentence that precedes it: “[r]atings shall be based, as far as practicable, upon the average impairments of earning capacity with the additional proviso that the Secretary shall from time to time readjust this schedule of ratings in accordance with experience.” The rule thus authorizes VA to assign ratings beyond those provided in the schedule even in advance of any necessary revision to the rating schedule. Further, there is a policy reason for limiting an extra-schedular evaluation under section 3.321(b)(1) to a single service-connected disability. As explained above, VA believes that the rule is consistent with the regulatory scheme, under which there is a distinction between application of the schedular criteria relating to specific disabilities and the application of the formula in 38 CFR 4.25 for combining individual disability ratings.

A commenter inquired about whether a veteran would be entitled to an extra-schedular rating for each service-connected disability. A veteran would be entitled to an extra-schedular rating for each service-connected disability that satisfies the criteria in the rule, i.e., (1) the schedular evaluation for the disability is inadequate; and (2) the disability is so exceptional or unusual due to related factors such as marked interference with employment or frequent periods of hospitalization.

One commenter stated that the rule appears to conflict with 38 CFR 3.102, which provides that VA will “administer the law under a broad interpretation.” We do not believe that there is a conflict because, rather than limit a veteran to a schedular rating that is “inadequate,” 38 CFR 3.321(b)(1) provides for an extra-schedular evaluation to account for an “exceptional or unusual disability” involving “marked interference with employment or frequent periods of hospitalization.”

One commenter wrote that the rule is inconsistent with VA's regulatory scheme for evaluating disabilities because it considers a disability in a vacuum, pointing to 38 CFR 4.10 regarding functional impairment and 38 CFR 3.383, which pertains to special consideration if a veteran has suffered loss of certain paired organs or extremities as a result of service-connected disabilities and non-service-connected disabilities.

The regulations cited by the commenter do not support the comment. Section 4.10 states that “[t]he basis of disability evaluations is the ability of the body as a whole . . . to function under the ordinary conditions of daily life including employment.” The cited statement, however, falls within Subpart A of the Part 4 regulations, which provides “regulations prescribing the policies and procedures for conducting VA medical examinations,” which are not considered a part of the rating schedule because “[t]he rating schedule consists only of those regulations that establish disabilities and set forth the terms under which compensation shall be provided.” Martinak v. Nicholson, 21 Vet. App. 447, 451-52 (2007) (citing 38 U.S.C. 1155); Vazquez-Flores v. Shinseki, 580 F.3d 1270, 1280 (Fed. Cir. 2009). “Thus, . . . the effects of a disability on one's daily life . . . are not relevant to a disability rating made by a ratings specialist.” Vazquez-Flores, 580 F.3d at 1280. While section 4.10 and related regulations make clear that fully descriptive medical examinations are needed to facilitate application of VA's rating schedule, they do not alter the operation of the rating schedule, which provides for disability ratings to be assigned for each separate disability under the applicable criteria of the rating schedule.

Section 3.383 of title 38, Code of Federal Regulations, implements 38 U.S.C. 1160, which provides that, in certain cases of paired organs or extremities in which a veteran has a non-service-connected disability attributable to one organ or extremity and a service-connected disability associated with the other organ or extremity, VA must pay compensation as if the combination of disabilities were the result of service-connected disability. Thus, Congress has specified the manner of considering the combined effects of these disabilities. Section 3.321(b)(1), on the other hand, fills a gap in 38 U.S.C. 1155 providing the Secretary with authority to address instances in which the ratings for individual disabilities under the schedule are not practicable or feasible.

One commenter stated that VA's proposed regulation does not take into account veterans who do not qualify for consideration of entitlement to a rating of total disability based upon individual unemployability (TDIU) under 38 CFR 4.16(b). The commenter states that a veteran may be forced to drop out of the workforce and apply for TDIU as a result of extra-schedular evaluations based upon a single disability.

Section 3.321(b)(1) addresses a different issue than section 4.16(a) and (b) were written to address. Section 3.321(b)(1) provides an exception to reliance upon a particular rating contained in the rating schedule where the schedule is determined to be inadequate in a particular case and examines the rating issue from the perspective of the schedule in rating a veteran's disability and provides adjustments to the schedule based on the veteran's disability. Section 4.16, on the other hand, looks at the situation from the perspective of the unemployability of an individual veteran. Under section 4.16(a) and (b), the deciding official looks at the overall impairment of a veteran to determine whether the veteran is employable regardless of the particular disability rating or combination of disability ratings awarded. Thus, section 3.321(b)(1) focuses on the schedule's failure to address the effect of a veteran's particular disability and the latter focuses upon the veteran's overall employability. Amending section 3.321(b)(1) based on this comment would also render section 4.16 superfluous because section 3.321(b)(1) could be the basis for a 100 percent extra-schedular rating which would be equivalent to a TDIU rating.

Another commenter stated that the combined ratings table is inadequate to compensate for the vast array of potential interactions between multiple disabilities. The commenter disputed VA's statement in the notice of proposed rulemaking that there is no mechanism for comparing the combined effects of multiple service-connected disabilities with the schedular criteria and contends, citing Yancy v. McDonald, 27 Vet. App. 484 (2016), that the Department can evaluate the combined effects of multiple disabilities and then compare those effects to the symptoms contemplated for individual disabilities.

The commenter misunderstands VA's statement. In Johnson, the Federal Circuit held that referral for an extra-schedular evaluation “may be based on the collective impact of the veteran's disabilities.” 762 F.3d at 1365. In Yancy, 27 Vet. App. at 495, the Veterans Court stated that the first step when considering entitlement to an extra-schedular evaluation is to decide whether the schedular evaluations reasonably contemplate the veteran's symptomatology, including any symptoms resulting from the combined effects of multiple service-connected disabilities. However, as VA explained in the notice of proposed rulemaking, there are no provisions in the rating schedule describing impairments associated with a particular combination of disabilities. 81 FR 23230. VA does not merely aggregate symptoms of a veteran's service-connected disabilities. Rather, VA evaluates the combined effects of multiple service-connected disabilities by “consider[ing] . . . the efficiency of the individual as affected first by the most disabling condition, then by the less disabling condition, then by other less disabling conditions, if any, in the order of severity.” 38 CFR 4.25. As a result, it is not possible for the Department to determine for purposes of 38 CFR 3.321(b)(1) whether the rating derived from application of section 4.25 is “inadequate” to compensate for the combined effects of these disabilities. 81 FR 23230.

If, in a particular case, evidence indicated that two or more service-connected disabilities combined to produce a symptom the claimant believed was not adequately addressed by the rating criteria for any of the individual disabilities at issue, the claimant could, under this rule, seek extra-schedular ratings for the individual conditions and VA would be required to evaluate the medical evidence in determining whether the rating schedule was adequate to evaluate each disabling condition, but would not be required to separately determine whether the combined rating resulting from 38 CFR 4.25 was adequate to evaluate the combined effects of the multiple disabilities.

A commenter stated that, to the extent that extraschedular evaluation of the combined effect of multiple disabilities may impose an additional burden on the Director of the Compensation Service, the decision should instead be made by regional offices (RO) and the Board of Veterans' Appeals. We agree that the ROs should make these fact-intensive decisions in the first instance, and we have therefore revised the rule by eliminating the phrase “upon field station submission” and the word “referred.”

Three commenters criticized the proposed rule on the basis that it does not provide guidance about how to apply the proposed rule or to the Board about how to review the Director's finding.

The standards for awarding an extra-schedular award are set forth in section 3.321(b) and have been included in the regulation since 1961. See 38 CFR 3.321(B) (1961). Extraschedular consideration is a question of fact “assessing a veteran's unique disability picture and whether that picture results in an average impairment in earning capacity significant enough to warrant an extraschedular rating.” Kuppamala v. McDonald, 27 Vet. App. 447, 454 (2015). Current VBA procedures require the RO to submit a memorandum to the Director that includes the evidence used for the review, including the medical evidence in detail for each service-connected disability. M21-1, Part III, Subpart iv, chapt. 6, § B, para. 4.d. and h. (July 25, 2017). The question for the VA decision maker is whether a veteran's disability is “exceptional or unusual” because the disability “marked[ly] interfere[s] with employment or [causes] frequent periods of hospitalization.” The Board's review of the matter is de novo and requires consideration of all evidence and information pertaining to whether the degree and frequency of an individual's veteran's disability interferes with employment or causes frequent periods of hospitalization. Kuppamala, 27 Vet. App. at 458-59.

One commenter stated that, in Kuppamala, the Secretary admitted that there are no manageable standards for the assignment of an extraschedular rating. In fact, the Secretary argued in Kuppamala “there are no judicially manageable standards governing the Director's decision as to extraschedular ratings,” which would make it impossible for the Board to review the decision. Id. at 452 (emphasis added). The Veterans Court concluded, however, that 38 U.S.C. 1155 and 38 CFR 3.321(b)(1) provide a judicially manageable standard. Id. at 454.

Another commenter stated that VA does not explain how it is possible to “'ensure fair and consistent application of rating standards'” given that 38 CFR 3.321(b)(1) requires an initial finding that the “schedular evaluation is inadequate.” (Quoting 81 FR 23231). The rating standards to which VA referred relate to a determination about whether a veteran is entitled to an extra-schedular evaluation, and as explained in the notice of proposed rulemaking, VA believes that the Department is able to fairly and consistently apply rating standards if consideration under section 3.321(b)(1) is limited to whether a rating for an individual disability is adequate as opposed to deciding whether a combined rating based upon residual work efficiency is adequate to rate multiple service-connected disabilities.

One commenter stated that the definition of the term “disability” in amended section 3.321(b)(1) is unclear and that an extra-schedular evaluation should be available for disability arising from a common disease entity or etiology. The commenter states that, if a veteran has a knee disability that causes both limitation or motion and instability, both effects of the disability should be evaluated together for purposes of entitlement to an extra-schedular rating.

“Words are not pebbles in alien juxtaposition; they have only a communal existence; and not only does the meaning of each interpenetrate the other, but all in their aggregate take their purport from the setting in which they are used.” Shell Oil Co. v. Iowa Dep't of Revenue, 488 U.S. 19, 25 n.6 (1988) (quoting Nat'l Labor Relations Bd. v. Federbush Co., 121 F.2d 954, 957 (2d Cir. 1941)). Section 3.321(b)(1) states that, “[t]o accord justice to the exceptional case where the schedular evaluation is inadequate to rate a single service-connected disability,” an extra-schedular evaluation may be approved. The requirement that VA consider the adequacy of the schedular evaluation means that the term “single service-connected disability” refers to the individual condition for which the schedular evaluation is inadequate, rather than the effects of a disability, each of which may be rated individually before receiving a combined rating.

Another commenter stated that the rule does not define “actual impairment in earning capacity” and posed a series of questions about how the term will be defined, e.g., whether a veteran must show loss of a certain amount of income as a result of the disability, and if so, how much of loss must the veteran suffer; whether inability to earn a higher level of income will suffice; and how will actual impairment in earning capacity be determined if a veteran is not employed. We have considered these comments and agree that an extra-schedular rating should be commensurate with the average rather than actual impairment of earning capacity due exclusively to the disability and we have revised the rule accordingly.

A commenter criticized the algorithm used to combine disabilities in 38 CFR 4.25. Another commenter remarked on the inadequacy of the rates in 38 U.S.C. 1114, but acknowledged that this comment is beyond the scope of the rulemaking. These comments are beyond the scope of the rulemaking, and we therefore make no change based on these comments.

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, and other advantages; distributive impacts; and equity). Executive Order 13563 (Improving Regulation and Regulatory Review) emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. Executive Order 12866 (Regulatory Planning and Review) defines a “significant regulatory action,” requiring review by the Office of Management and Budget (OMB), unless OMB waives such review, as “any regulatory action that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in this Executive Order.”

The economic, interagency, budgetary, legal, and policy implications of this regulatory action have been examined, and it has been determined not to be a significant regulatory action under Executive Order 12866. VA's impact analysis can be found as a supporting document at http://www.regulations.gov, usually within 48 hours after the rulemaking document is published. Additionally, a copy of this rulemaking and its impact analysis are available on VA's Web site at http://www.va.gov/orpm/, by following the link for “VA Regulations Published From FY 2004 Through Fiscal Year to Date.”

The Secretary hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act (5 U.S.C. 601-612). This final rule will directly affect only individuals and will not directly affect small entities. Therefore, pursuant to 5 U.S.C. 605(b), this rulemaking is exempt from the initial and final regulatory flexibility analysis requirements of sections 603 and 604.

The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year. This final rule would have no such effect on State, local, and tribal governments, or on the private sector.

This final rule contains no provisions constituting a collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).

The Catalog of Federal Domestic Assistance numbers and titles for the programs affected by this document are 64.109, Veterans Compensation for Service-Connected Disability.

The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Gina S. Farrisee, Deputy Chief of Staff, Department of Veterans Affairs, approved this document on November 13, 2017, for publication.

For the reasons stated in the preamble, the Department of Veterans Affairs amends 38 CFR part 3 as set forth below:

In the direct final rule, EPA stated that if adverse comments were submitted by November 17, 2017, the rule would be withdrawn and not take effect. EPA received an adverse comment prior to the close of the comment period and, therefore, is withdrawing the direct final rule. EPA will address the comment in a subsequent final action based upon the proposed action also published on October 18, 2017 (82 FR 48473). EPA will not institute a second comment period on this action.

On July 17, 2014, the District of Columbia (the District) through the District Department of Energy and the Environment (DDOEE) submitted a SIP revision addressing the infrastructure requirements under section 110(a)(2) of the Clean Air Act (CAA) for the 2010 1-hour SO2 NAAQS. In the direct final rule published on October 18, 2017 (82 FR 48439), EPA stated that if EPA received adverse comments by November 17, 2017, the rule would be withdrawn and not take effect. EPA subsequently received adverse comments from anonymous commenters.

Because adverse comments were received, EPA is withdrawing the direct final rule approving the revision to the District of Columbia SIP pertaining to the interstate transport requirements for the SO2 NAAQS promulgated by EPA on October 18, 2017 (82 FR 48439). EPA will respond to the adverse comments in a separate final rulemaking action.

In the direct final rule, EPA stated that if adverse comments were submitted by November 20, 2017, the rule would be withdrawn and not take effect. EPA received an adverse comment prior to the close of the comment period and, therefore, is withdrawing the direct final rule. EPA will address the comment in a subsequent final action based upon the proposed action also published on October 20, 2017 (82 FR 48780). EPA will not institute a second comment period on this action.

In the direct final rule, EPA stated that if adverse comments were submitted by November 17, 2017, the rule would be withdrawn and not take effect. EPA received an adverse comment prior to the close of the comment period and, therefore, is withdrawing the direct final rule. EPA will address the comment in a subsequent final action based upon the proposed action also published on October 18, 2017 (82 FR 48473). EPA will not institute a second comment period on this action.

The SIP is a living document that a state revises as necessary to address its unique air pollution problems. Therefore, from time to time, the EPA must take action on SIP revisions containing new and/or revised regulations, approving and incorporating them into the SIP. On May 22, 1997, the EPA revised the procedures for incorporating by reference federally-approved SIPs, as a result of consultations between the EPA and the Office of the Federal Register (OFR) (62 FR 27968). The description of the revised SIP document, IBR procedures and “Identification of plan” format is discussed in further detail in the May 22, 1997, Federal Register document. On April 10, 2014, the EPA published a Federal Register beginning the new IBR procedure for Alaska (79 FR 19820). Since then, the EPA has approved and incorporated by reference the following provisions of Alaska Administrative Code (18 AAC 50), Alaska Statutes (AS), and Fairbanks North Star Borough (FNSB) Code into the Alaska SIP.

In this action, the EPA is announcing the update to the IBR material as of September 8, 2017. The EPA is correcting minor typographical errors and rearranging and republishing the contents of subsection 52.70(c). The EPA is also rearranging and republishing the contents of subsection 52.70(e) to align the contents with the outline of the Alaska state plan volumes and sections. We note we are correcting entries 18 AAC 50.075 and 18 AAC 50.077 in subsection 52.70(c) to accurately reflect the portions of these rule sections that were withdrawn by the State and not approved into the SIP (September 8, 2017, 82 FR 42457). We are also correcting the table in subsection 52.70(e) to reflect our approval of the appendices to the Regional Haze Plan at entry III.III.K. (February 14, 2013, 78 FR 10546) and our most recent approval of the State Air Statutes at entry III.II.A. (September 19, 2014, 79 FR 56268).

The EPA has determined that this rule falls under the “good cause” exemption in section 553(b)(3)(B) of the Administrative Procedures Act (APA) which, upon finding “good cause,” authorizes agencies to dispense with public participation and section 553(d)(3) which allows an agency to make a rule effective immediately (thereby avoiding the 30-day delayed effective date otherwise provided for in the APA). This rule simply codifies provisions which are already in effect as a matter of law in federal and approved state programs. Under section 553 of the APA, an agency may find good cause where procedures are “impractical, unnecessary, or contrary to the public interest.” Public comment is “unnecessary” and “contrary to the public interest” since the codification only reflects existing law. Immediate notice in the CFR benefits the public by removing outdated citations and incorrect table entries.

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 previously EPA-approved regulations promulgated by Alaska and federally-effective prior to September 8, 2017. The EPA has made, and will continue to make, these materials generally available through www.regulations.gov and/or at the EPA Region 10 Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information).

Under the Clean Air Act (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, the 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 (Public Law 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 this action does not involve technical standards; 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 as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it impose substantial direct costs on tribal governments or preempt tribal law.

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 Alaska regulations 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/or in hard copy at the appropriate EPA office (see the ADDRESSES section of this preamble for more information).

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 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 rule is not a “major rule” as defined by 5 U.S.C. 804(2).

The EPA has also determined that the provisions of section 307(b)(1) of the CAA pertaining to petitions for judicial review are not applicable to this action. Prior EPA rulemaking actions for each individual component of the Alaska SIP compilations had previously afforded interested parties the opportunity to file a petition for judicial review in the United States Court of Appeals for the appropriate circuit within 60 days of such rulemaking action. Thus, the EPA sees no need in this action to reopen the 60-day period for filing such petitions for judicial review for this “Identification of plan” update action for Alaska.

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

In the direct final rule, EPA stated that if adverse comments were submitted by November 17, 2017, the rule would be withdrawn and not take effect. EPA received an adverse comment prior to the close of the comment period and, therefore, is withdrawing the direct final rule. EPA will address the comment in a subsequent final action based upon the proposed action also published on October 18, 2017 (82 FR 48472). EPA will not institute a second comment period on this action.

Due to adverse comments, EPA is withdrawing the direct final rule to approve the states “infrastructure” SIP revision for the 2010 NO2 NAAQS. In the direct final rule published on October 11, 2017 (82 FR 47154), EPA stated that if it received adverse comment by November 13, 2017, the rule would be withdrawn and not take effect. EPA received adverse comments. EPA will address the comments in a subsequent final action based upon the proposed action also published on October 11, 2017 at 82 FR 47170. EPA will not institute a second comment period on this action.

Due to adverse comments, EPA is withdrawing the direct final rule to approve the states “infrastructure” SIP revision for the 2012 PM2.5 NAAQS. In the direct final rule published on October 11, 2017, (82 FR 47147), EPA stated that if it received adverse comment by November 13, 2017, the rule would be withdrawn and not take effect. The direct final rule was an approval of a State Implementation Plan (SIP) revision from the State of Missouri for the 2012 PM2.5 National Ambient Air Quality Standard (NAAQS). The direct final approval action also included the approval of Missouri State Statue section 105.483(5) RSMo 2014, and Missouri State Statue section 105.485 RSMo 2014 into the SIP. These two statutes address aspects of the infrastructure requirements relating to conflicts of interest as found in section 128 of the CAA. EPA received adverse comments. EPA will address the comments in a subsequent final action based upon the proposed action also published on October 11, 2017, at 82 FR 47169. EPA will not institute a second comment period on this action.

On September 12, 2017 (82 FR 42767), EPA published a notice of proposed rulemaking (NPR) for the State of Delaware. In the NPR, EPA proposed approval of Delaware's SIP revision pertaining to the RACT requirements under the 2008 8-hour ozone NAAQS. The formal SIP revision was submitted by Delaware on May 4, 2015.

On May 4, 2015, Delaware submitted a SIP revision to address all the requirements of RACT set forth by the CAA under the 2008 8-hour ozone NAAQS (the 2015 RACT Submission). Specifically, Delaware's 2015 RACT Submission includes: (1) A certification that for certain categories of sources previously adopted nitrogen oxide (NOX) and volatile organic compound (VOC) RACT controls in Delaware's SIP that were approved by EPA under the 1979 1-hour and 1997 8-hour ozone NAAQS are based on the currently available technically and economically feasible controls, and continue to represent RACT for implementation of the 2008 8-hour ozone NAAQS; (2) the adoption of new or more stringent regulations or controls that represent RACT control levels for certain categories of sources; and (3) a negative declaration that certain control technique guidelines (CTGs) or non-CTG major sources of VOC and NOX sources do not exist in Delaware.

EPA has reviewed Delaware's 2015 RACT Submission and finds Delaware's certification of the RACT regulations for major sources of VOC and NOX previously approved by EPA for the 1-hour and 1997 8-hour ozone NAAQS continue to represent RACT-level controls for the source categories for the 2008 8-hour ozone NAAQS. EPA finds that Delaware's major stationary source VOC and NOX regulations represent the lowest emission limits based on currently available and economically feasible control technology for these source categories. EPA also finds that Delaware's SIP implements RACT with respect to all sources of VOCs covered by a CTG issued prior to July 20, 2014 and all major stationary sources of VOC and NOX via Delaware's regulations and case-by-case RACT. EPA accepts Delaware's negative declarations that the following VOC CTG source categories do not exist in Delaware: Manufacture of pneumatic rubber tires; wood furniture manufacturing operations; shipbuilding and ship repair operations (surface coating); and fiberglass boat manufacturing materials. EPA's review indicates that Delaware's 2015 RACT Submission meets the RACT requirements for the 2008 8-hour ozone NAAQS for applicable CTG source categories and major stationary sources of VOC and NOX to address sections 182(b), 182(f) and 184(b)(2) of the CAA.

With respect to the previous case by case RACT determinations submitted by Delaware and approved by EPA for the Delaware SIP, the CAA section 110(l) states “The Administrator shall not approve a revision of a plan if the revision would interfere with any applicable requirement concerning attainment and reasonable further progress (RFP) or any applicable requirement of the CAA.” EPA finds that the removal of the emission limits for (1) the Polyhydrate Alcohol Catalyst Regenerative process SPI Polyols, Incorporated, (2) the sulfuric acid process and inter-stage absorption system at General Chemical Corporation and (3) the metallic nitrite process at General Chemical Corporation from the Delaware SIP will not interfere with attainment of any NAAQS or with RFP or any applicable requirement of the CAA because these sources have permanently shut down and thus emissions have been completely eliminated. EPA finds the NOX RACT determination for CitiSteel USA, Incorporated, Electric Arc Furnace (EAF) continues to represent the lowest emission limitation that is reasonably available considering technological and economic feasibility for this source. With respect to the Fluid-Coking Unit (FCU) and Fluid Catalytic Cracking Unit (FCCU) at the Delaware City Refinery Company, EPA finds that the emission limits, compliance requirements and recordkeeping and reporting requirements established by Delaware represent RACT level of control for these units.

Other specific requirements of Delaware's SIP submission addressing 2008 8-hour ozone RACT and the rationale for EPA's proposed action are explained in the NPR and technical support document (TSD) and will not be restated here.

On May 22, 2015, the EPA Administrator signed a final action, EPA's SSM SIP Call (formally, the “State Implementation Plans: Response to Petition for Rulemaking; Restatement and Update of EPA's SSM Policy Applicable to SIPs; Findings of Substantial Inadequacy; and SIP Calls to Amend Provisions Applying to Excess Emissions During Periods of Startup, Shutdown and Malfunction”). 80 FR 33839. As discussed in the NPR, Delaware relies upon both Regulation 1124 and Regulation 1142 to meet its RACT obligations for the 2008 ozone NAAQS. Therefore, our review of the Delaware 2015 RACT Submission necessarily included our review of Regulation 1124 and 1142, which were subject to EPA's SSM SIP Call because at the time EPA found that the provisions gave the State discretion to create exemptions allowing excess emissions during startup and shutdown. In 2016, Delaware revised Regulations 1124 and 1142 in the State law to remove the provisions identified by EPA in EPA's SSM SIP Call, and Delaware subsequently submitted, on November 21, 2016, a SIP revision to address EPA's SSM SIP Call for Regulation 1124 (subsection 1.4) and Regulation 1142 (subsection 2.3.1.6). EPA has not yet taken final action on that submittal; any action on Delaware's November 21, 2016 SSM SIP revision would be done through a separate rulemaking action.

As stated in the NPR, the EPA is actively reviewing the SSM SIP Call. Therefore, in the NPR, EPA proposed to approve the 2015 RACT Submission under two alternative bases.

EPA proposed to approve Delaware's 2015 RACT Submission on the basis that either (1) a change in EPA's SSM policy and withdrawal of the SSM SIP Call as to Delaware Regulations 1124 and 1142 would occur, or (2) a separate final rulemaking action approving the revised versions of Regulations 1124 and 1142 as revised in Delaware's response to the SSM SIP Call would occur. Under either basis, EPA proposed to find that Delaware's 2015 RACT Submission is fully consistent with CAA requirements for RACT. EPA was clear that either alternative basis for approval of the Delaware RACT assumed a separate Agency action. EPA did not propose to effectuate either action in this rulemaking. Therefore, EPA did not consider those issues open for public comment as part of this rulemaking action. Any comments filed on this rulemaking that relate to the possibility of EPA changing the SSM Guidance generally, a possible withdrawal of EPA's SSM SIP Call as to Delaware Regulations 1124 and 1142, or a possible action by EPA on Delaware's SIP submittal in response to the SSM SIP call are outside the scope of this rulemaking, which is limited to EPA's action on Delaware's 2015 RACT Submission.

In the proposal, EPA made clear that under either alternative scenario regarding the SSM SIP Call, EPA would deem approval of Delaware's RACT SIP appropriate. Therefore, although EPA has not yet taken separate action related to the SSM SIP Call (to either withdraw the SIP Call as to Regulations 1124 and 1142 or to act on Delaware's SSM SIP submittal), we are approving today Delaware's 2015 RACT Submission because it meets RACT requirements under the CAA for the 2008 8-hour ozone NAAQS for the reasons discussed herein and as proposed in the NPR and in the TSD for this rulemaking.1 We do not believe the SSM SIP Call prevents our final approval of the 2015 RACT Submission as it otherwise meets all CAA RACT requirements. First, as discussed in the NPR, because EPA is reviewing the SSM SIP Call, if EPA later withdraws portions that apply to Delaware's regulations, the regulations Delaware relies upon for RACT in Regulations 1124 and 1142 fully meet CAA requirements including requirements for emission limitations as well as RACT in sections 110, 172, 182 and 184 of the CAA. Alternatively, if EPA concludes its review and implements the SSM SIP Call, Delaware has already submitted a SIP revision in November 2016 that comprises revised versions of Regulations 1124 and 1142 that lack the director discretion provisions that EPA said in the SSM SIP Call were inconsistent with the CAA. EPA is approving the 2015 RACT Submission because, under the first scenario, if EPA withdraws its SSM SIP Call with respect to Delaware, Delaware's regulations in the SIP would be in compliance with CAA requirements, and, under the second scenario, if EPA continues to implement the SSM SIP Call, Delaware has either already submitted a revision complying with CAA requirements or, to the extent EPA determines that the already submitted revision is inadequate, Delaware will be required to submit a new or supplemental revision to address any deficiencies.

EPA received adverse public comments on the NPR. EPA has summarized the comments and provides responses to the adverse comments below. All other comments received were not specific to this action and thus are not addressed here.

Comment: One comment received from the SSM Coalition states that the CAA does not require nor authorize the EPA to declare SIPs to be inadequate due to provisions exempting or providing alternative requirements during periods of startup, shutdown or malfunction. The commenter notes that the EPA's SSM SIP Call rule states that the “SSM SIP Policy” is not binding on EPA and thus constitutes guidance. As guidance, this SSM Policy as of 2015 does not bind the states, the EPA nor other parties, but it does reflect the EPA's interpretation of CAA statutory requirements. The commenter refers to comments it previously filed on EPA's SSM SIP Call rulemaking. The commenter states EPA is free to approve the Delaware RACT provisions without first acting on provisions identified in the SSM SIP Call as the commenter asserts the state has the discretion to include SSM provisions in its SIP. The commenter also stated EPA should revise its SSM SIP policy and withdraw the SSM SIP Call as to Delaware before approving the 2015 RACT Submission.

Response: As EPA stated in the NPR, any comments filed on this rulemaking that relate to the possibility of EPA changing the SSM Guidance generally or a possible withdrawal of EPA's SSM SIP Call as to Delaware Regulations 1124 and 1142 are outside the scope of this rulemaking, which is limited to EPA's action on Delaware's 2015 RACT Submission. Any EPA action to either withdraw the SSM SIP Call as to Delaware Regulations 1124 and 1142 or act on Delaware's SSM SIP submittal will be a separate Agency action.

Comment: Two commenters, the Environmental Integrity Project (EIP) 2 and an anonymous commenter, state that the Delaware provisions identified in EPA's SSM SIP Call contain impermissible exemptions to emission limitations under the CAA and, therefore, must be corrected before EPA can approve the Delaware 2015 RACT Submission. Commenters argue that approving the Delaware regulations as RACT with SSM exemptions in them violates the CAA requirement that SIPs include enforceable limitations which must apply at all times. Specifically, CAA sections 110(a)(2)(A) and 302(k) require SIPs to include enforceable emission limitations, which must apply on a continuous basis. Contrary to these requirements, the provisions in Delaware Regulations 1124 and 1142 give Delaware unbounded discretion to allow exemptions from SIP limits and therefore would not be emissions limitations that apply on a “continuous” basis. These provisions also interfere with the applicable requirements of the CAA because they allow Delaware to alter SIP limits through a process that is contrary to CAA section 110(i). Section 110(i) provides that revisions to SIP provisions take place through specified routes, including formal SIP revision processes. The provisions in Delaware Regulations 1124 and 1142, however, allow the state to alter the SIP limits through a permit process that does not fall into any of the allowed routes for SIP revision under section110(i) and does not require EPA approval. Similarly, the commenter states that the SSM exemptions in Regulations 1124 and 1142 are contrary to the CAA requirements for nonattainment areas in that section 172(c)(6) of the CAA requires nonattainment SIP provisions to include enforceable emission limitations to provide for attainment of the NAAQS, and these limitations required for nonattainment areas by CAA section 172 must also apply on a continuous basis and be enforceable to also meet CAA section 110(a)(2) requirements. The commenter asserted EPA made no claim that the Delaware provisions which include SSM provisions constitute RACT. Lastly, the commenter states that EPA's approval of the 2015 RACT Submission would be otherwise arbitrary and capricious as the SSM provisions in Delaware Regulations 1124 and 1142 would undermine enforcement of emissions limitations by EPA or citizens as the Delaware provisions identified in the SSM SIP Call would create alternative limits which are not enforceable or would interfere with CAA requirements for continuous emission limitations. The commenter asserts that emission limitations or exemptions from limits established outside the SIP revision process would interfere with attainment and maintenance of the NAAQS and thus with air quality in Delaware. The commenter asserts that if EPA approves the 2015 RACT Submission, EPA must acknowledge its departure from the SSM SIP Call and SSM policy and explain its position; otherwise, action approving the Delaware 2015 RACT Submission would be arbitrary and capricious. Finally, the commenter stated EPA cannot approve the Delaware regulations as meeting RACT while these regulations were found impermissible under the SSM SIP Call on either the hope SSM policy is changed or on the assumption Delaware's SSM November 2016 SIP revision is adequate. The commenter supports this statement because portions of Delaware Regulations 1124 and 1142 were found “substantially inadequate” to meet CAA requirements which would include RACT. The commenter says EPA assuming Delaware's November 2016 SIP revision addressing SSM provisions is adequate would preclude public participation and predetermines the outcome of rulemaking on that SIP. The commenter said EPA must first resolve SSM policy before approving the 2015 RACT Submission or address SSM policy before acting and take action on the November 2016 SIP revision addressing the SSM SIP Call.

Response: EPA notes that commenters' statements are repeating arguments made in support of the SSM SIP Call. As stated previously, such comments relating to the SSM SIP Call and its statutory and policy basis in accordance with the CAA are outside the scope of this rulemaking. EPA's action here is limited to EPA's action on Delaware's 2015 RACT Submission. EPA explained above how we are approving the 2015 RACT Submission with the provisions which were identified in the SSM SIP Call as we find the Delaware regulations address RACT and CAA requirements for emission limitations. Thus, we disagree with the commenter that we cannot approve this 2015 RACT Submission without first “settling” SSM policy issues. If EPA, after concluding its reviewing of the SSM SIP Call, acts to withdraw the SSM SIP Call, then no further action is needed for the versions of Regulation 1124 and 1142 in the Delaware SIP as the Delaware regulations fully address RACT for 2008 ozone. If EPA after its review continues implementing the SSM SIP Call, EPA will act in a separate rulemaking on Delaware's SIP revision submittal which, if approved, would remove from the Delaware SIP the provisions related to SSM in Regulations 1124 and 1142.

Contrary to the commenter's assertion that EPA made “no claim” that Delaware's emission limits and control measures containing SSM constitute RACT, EPA explained in detail in both the NPR and in the TSD prepared in support of the rulemaking how Regulations 1124 and 1142 address RACT requirements for the 2008 ozone NAAQS.3 EPA's explanation and analysis outlined how the Delaware regulations and measures reflect the currently available technically and economically feasible controls and the lowest achievable emission limitations for major stationary sources required to have NOX and VOC RACT. EPA also explained in detail in the NPR and TSD how provisions in Regulation 1124 met requirements for CTGs to be in the Delaware SIP as required by CAA sections 182 and 184.

Finally, as specifically stated in the NPR, EPA noted that we cannot prejudge a final approval on Delaware's November 2016 SSM SIP Call submission. EPA explained in the NPR we would take public comment on any proposal to act on that November 2016 SIP and that if EPA would change direction based on comments received on any such proposed rulemaking to approve that SIP submission, we would not be able to approve the SSM SIP Call submission.

EPA is approving the State of Delaware's May 4, 2015 SIP revision submittal (the 2015 RACT Submission) which addresses the 2008 8-hour ozone NAAQS RACT requirements as a revision to the Delaware SIP.

In this rule, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of source specific RACT determinations under the 2008 8-hour ozone NAAQS for certain major sources of NOX and VOC emissions in the State of Delaware as described in the amendments to 40 CFR part 52 set forth below. EPA has made, and will continue to make, these materials generally available through http://www.regulations.gov and/or at the EPA Region III Office (please contact the person identified in the “For Further Information Contact” section of this preamble for more information). Therefore, these materials have been approved by EPA for inclusion in the SIP, have been incorporated by reference by EPA into that plan, are fully federally enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking of EPA's approval, and will be incorporated by reference by the Director of the Federal Register in the next update to the SIP compilation.4

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 Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

• is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866.

• 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 (Public Law 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).

In addition, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.

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 February 6, 2018. 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 approving the Delaware RACT requirements under the 2008 8-hour ozone NAAQS may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

40 CFR part 52 is amended as follows:

In the direct final rule, EPA stated that if adverse comments were submitted by November 17, 2017, the rule would be withdrawn and not take effect. EPA received an adverse comment prior to the close of the comment period and, therefore, is withdrawing the direct final rule. EPA will address the comment in a subsequent final action based upon the proposed action also published on October 18, 2017 (82 FR 48475). EPA will not institute a second comment period on this action.

In the direct final rule, EPA stated that if adverse comments were submitted by November 17, 2017, the rule would be withdrawn and not take effect. EPA received an adverse comment prior to the close of the comment period and, therefore, is withdrawing the direct final rule. EPA will address the comment in a subsequent final action based upon the proposed action also published on October 18, 2017 (82 FR 48474). EPA will not institute a second comment period on this action.

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 EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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-2016-0536 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 February 6, 2018. 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-2016-0536, 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 November 30, 2016 (81 FR 86312) (FRL-9954-06), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 6F8493) by United Phosphorus, Inc., 630 Freedom Business Center, Suite 402, King of Prussia, PA 19406. The petition requested that 40 CFR 180 be amended by establishing a tolerance for residues of the fungicide ziram, zinc dimethyldithiocarbamate, in or on filbert (hazelnut) at 0.1 parts per million (ppm). That document referenced a summary of the petition prepared by United Phosphorus, Inc., the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

Based upon review of the data supporting the petition, EPA has revised the tolerance value to add an additional significant figure and also revised the commodity term from filbert (hazelnut) to hazelnut. The reason for this change is explained in Unit IV.C.

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish 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. . . .”

Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), 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 ziram including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with ziram follows.

EPA has evaluated the available toxicity data and considered its 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.

The primary target organs of ziram are the nervous system, liver, and thyroid. A single oral dose causes neurological impairments (ataxia and slight impaired gait) while repeated short-term exposure results in inhibition of brain cholinesterase and brain neurotoxic esterase in rats. Developmental neurotoxic effects were not observed in offspring of the most recent DNT study. Liver histopathology was identified throughout the database at various doses in the rat subchronic and chronic studies and the mouse carcinogenicity study, and at times is accompanied by increases in hepatic serum enzyme levels. Chronic studies also included thyroid effects, specifically follicular cell hypertrophy and c-cell carcinoma. When ziram was administered orally in rats, it was rapidly absorbed, distributed, and excreted via urine, expired air, and excreted feces within 72 hours. Small amounts were widely distributed in the body with the highest tissue concentrations in the liver, fat, kidney, spleen, lung, thyroid, and adrenals. Metabolites were not identified.

There is no quantitative or qualitative evidence of increased susceptibility following in utero exposure to rats and rabbits and following pre-/postnatal exposure to rats in the developmental, reproduction, and developmental neurotoxicity studies with ziram. There was an apparent quantitative evidence of increased susceptibility identified in an older unacceptable developmental neurotoxicity study in rats. Increased motor activity was observed in the offspring at the lowest dose tested, while the maternal rats exhibited reduced body weights and/or body weight gains, and decreased food consumption during gestation and lactation at the highest dose tested. However, this study was classified as unacceptable since brain morphometric analysis—a key evaluation in DNTs—was not conducted. A second DNT study was submitted and does not demonstrate quantitative susceptibility. This second DNT identifies a clear NOAEL and includes brain morphometric data on post-natal day 21 and 72 rats with no treatment-related effects.

Based on the occurrence of benign tumors (hemangiomas) in male CD (SD) BR male rats, supported by an increasing trend in preputial gland adenomas in male F344 rats. However, since no hemangiosarcomas or preputial gland carcinomas were observed, no treatment-related increase in tumors was identified in the female CD(SD) BR or female F344/N rat, and because ziram was not carcinogenic to CD-1 mice (both genders), and there is no concern regarding mutagenicity, the EPA has determined that quantification of risk using a non-linear approach (i.e., RfD) will adequately account for all chronic toxicity, including carcinogenicity, that could result from exposure to ziram.

Ziram has low acute toxicity via the dermal and oral routes. However, ziram is classified as Toxicity Category I for eye irritation and a Category II for the acute inhalation study. Ziram is also a moderate dermal sensitizer. Specific information on the studies received and the nature of the adverse effects caused by ziram as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document “Ziram. Human Health Risk Assessment for Proposed New Use on Hazelnuts (Filberts) in Tree Nuts Crop Group 14-12”, pages 12-17, in docket ID number EPA-HQ-OPP-2016-0536.

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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.

A summary of the toxicological endpoints for ziram used for human risk assessment is shown in the Table of this unit.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to ziram, EPA considered exposure under the petitioned-for tolerances as well as all existing ziram tolerances in 40 CFR 180.116. EPA assessed dietary exposures from ziram in food as follows:

i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure.

Such effects were identified for ziram. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) Nationwide Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA) conducted from 2003-2008. As to residue levels in food, the acute dietary analysis was obtained from the Dietary Exposure Evaluation Model using the Food Commodity Intake Database (DEEM-FCID; version 3.16). The assessment is based on the maximum percent crop treated estimates for some commodities and assumed 100% crop treated for all others. The analyses also assumed a distribution of residues based on field trial data or the Food and Drug Administration (FDA) monitoring data.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA Nationwide Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA) conducted from 2003-2008. As to residue levels in food, the chronic dietary analysis was obtained from the Dietary Exposure Evaluation Model using the Food Commodity Intake Database (DEEM-FCID; version 3.16). The assessment is based on the average percent crop treated estimates for some commodities and assumed 100% crop treated for all others. The analyses also assumed a distribution of residues based on field trial data or the FDA monitoring data.

iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that a nonlinear RfD approach is appropriate for assessing cancer risk to ziram. Cancer risk was assessed using the same exposure estimates as discussed in Unit III.C.1.ii., chronic exposure.

iv. Anticipated residue and percent crop treated (PCT) information. Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must require pursuant to FFDCA section 408(f)(1) that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. For the present action, EPA will issue such data call-ins as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be required to be submitted no later than 5 years from the date of issuance of these tolerances.

Section 408(b)(2)(F) of FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if:

• Condition a: The data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain the pesticide residue.

• Condition b: The exposure estimate does not underestimate exposure for any significant subpopulation group.

• Condition c: Data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area.

In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by FFDCA section 408(b)(2)(F), EPA may require registrants to submit data on PCT.

The Agency estimated the maximum PCT for existing uses as follows in the acute dietary risk assessment: Almonds: 35%; apples: 20%; apricots: 70%; blueberries: 40%; cherries: 15%; grapes: 10%; nectarines: 65%; peaches: 40%; pears: 35%; pecans: 2.5%; and tomatoes: 6%.

The following average percent crop treated estimates were used in the chronic dietary risk assessments for the following crops that are currently registered for ziram: almonds: 15%; apples: 15%; apricots: 35%; blueberries: 30%; cherries: 5%; grapes: 5%; nectarines: 45%; peaches: 25%; pears: 15%; pecans: 2.5%; and tomatoes: 6%.

For strawberries, the Agency calculated percent detectable residue values from the FDA samples and used that number (4.5%) in the acute and chronic evaluations.

In most cases, EPA uses available data from United States Department of Agriculture/National Agricultural Statistics Service (USDA/NASS), proprietary market surveys, and the National Pesticide Use Database for the chemical/crop combination for the most recent 6-7 years. EPA uses an average PCT for chronic dietary risk analysis. The average PCT figure for each existing use is derived by combining available public and private market survey data for that use, averaging across all observations, and rounding to the nearest 5%, except for those situations in which the average PCT is less than 5%. In those cases, EPA rounds to either 2.5% or 1%, whichever is appropriate. EPA uses a maximum PCT for acute dietary risk analysis. The maximum PCT figure is the highest observed maximum value reported within the recent 6 years of available public and private market survey data for the existing use and rounded up to the nearest multiple of 5%, except when the maximum PCT is less than 5%; then EPA uses 2.5%.

The Agency believes that the three conditions discussed in Unit III.C.1. iv. have been met. With respect to Condition a, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions b and c, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available reliable information on the regional consumption of food to which ziram may be applied in a particular area.

2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for ziram in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of ziram. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.

Based on the Pesticide Water Calculator (PWC 1.52) and Pesticide Root Zone Model Ground Water (PRZM GW), the estimated drinking water concentrations (EDWCs) of ziram for acute exposures are estimated to be 103.7 parts per billion (ppb) for surface water and <0.001 ppb for ground water. For chronic exposures for non-cancer assessments are estimated to be 2.74 ppb for surface water and <0.001 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 103.7 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 2.74 ppb was used to assess the contribution to drinking water.

3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets).

There are no conventional residential uses of ziram. However, there is a registered use of exterior latex paint, an antimicrobial use, for ziram which could result in residential exposures. The registered antimicrobial use in exterior latex paint (in-can-preservative) may be used by a homeowner and applied either by airless sprayer or by brush. Short-term aggregate risk assessments were previously conducted for adults only; the sole registered scenario resulting in residential exposures. Residential handler risks are not of concern for the loading/application of exterior latex paints either by airless spray or brush (i.e., the combined dermal and inhalation MOE is >100). Residential post-application inhalation exposures are expected to be negligible due to the low vapor pressure of ziram (1.4E-7 mmHg at 25 °C) and low dermal contact potential to treated surfaces.

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.”

The Agency reevaluated the existing data suggesting that the dithiocarbamates can be grouped based on a common mechanism of toxicity. The dithiocarbamates included were mancozeb, maneb, metiram, Na-dimethyldithiocarbamate, ziram, thiram, ferbam, and metam sodium. EPA concluded that the available evidence shows that the neuropathology induced by treatment of rats with the dithiocarbamates cannot be linked with the formation of carbon disulfide because: (a) The neuropathology induced by the dithiocarbamates is not consistent with the neuropathology induced by exposure to carbon disulfide, (b) there is a lack of concordance between doses of the dithiocarbamates that induce neuropathology and the amounts of carbon disulfide formed during metabolism and (c) there is evidence that more than one mechanism of toxicity could be operative that accounts for dithiocarbamate induced neuropathology because there is no consistent pattern of neuropathology reported in studies with this subgroup of carbamates. Accordingly, the available evidence does not support grouping the dithiocarbamates based on a common mechanism for neuropathology. For the purposes of this tolerance action, therefore, EPA has assumed that ziram 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

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 no quantitative or qualitative evidence of increase in susceptibility following in utero exposure to rats and rabbits and following pre-/postnatal exposure to rats in the developmental, the reproduction, and the acceptable DNT studies with ziram.

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 for all scenarios except acute dietary, for which the FQPA SF is being reduced to 3X. That decision is based on the following findings:

i. The toxicity database for ziram is adequate for evaluating and characterizing its toxicity, except for where a NOAEL is extrapolated from a LOAEL in the acute neurotoxicity study used as the endpoint for assessing acute dietary exposure. EPA has determined that a 3x FQPA SF to account for the extrapolation is sufficient to protect infants and children because of the impacts observed at the LOAEL were minimal and other studies did not show effects occurring at similar doses.

ii. There is indication that ziram is a neurotoxic chemical and an acceptable developmental neurotoxicity study has been submitted. A single oral dose resulted in ataxia in both sexes and slight impaired gait in males. Repeated short term oral exposure resulted in inhibition of brain cholinesterase in both sexes and brain neurotoxic esterase activity in male rats. Developmental neurotoxic effects were not observed in offspring of the most recent DNT study. Chronic dietary exposure in adult rats resulted in atrophy and reductions in crural muscle weights. Crural muscles function in the motion of the rodent's grasping foot claw.

iii. There is no evidence that ziram results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies, in young rats in the 2-generation reproduction study, or in the most recent DNT study.

iv. There are no residual uncertainties identified in the exposure databases. The dietary and non-dietary exposure estimates were based on several conservative assumptions and will not underestimate the exposure and risk. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to ziram in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by ziram.

EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (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. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to ziram will occupy 26% of the aPAD for children 1-2 years old, the population group receiving the greatest exposure.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to ziram from food and water will utilize 1.4% of the cPAD for Children 1-2, the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of ziram is not expected.

3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

Ziram is currently registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to ziram.

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 170 for adults. Because EPA's level of concern for ziram is a MOE of 100 or below, these MOEs are not of concern.

4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Because no intermediate-term adverse effect was identified, ziram is not expected to pose an intermediate-term risk.

5. Aggregate cancer risk for U.S. population. As discussed in Unit III.A., the Agency has determined that quantification of risk using a non-linear approach (i.e., RfD) will adequately account for all chronic toxicity, including carcinogenicity, that could result from exposure to ziram. Because the Agency's assessment indicates that aggregate exposure will be below the Agency's level of concern for chronic risk, the Agency concludes such exposure will not pose an aggregate cancer risk.

6. 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 ziram residues.

Adequate enforcement methodology (colorimetric method, Method I) is available to enforce the tolerance expression.

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level. The Codex has not established a MRL for ziram.

EPA revised the 0.1 ppm value to 0.10 ppm based on the practice to add the additional significant figure to provide clarity about permissible residues. In addition, the commodity term for the tolerance was revised from filbert (hazelnut) to hazelnut to be consistent with the general food and feed commodity vocabulary EPA uses for tolerances and exemptions.

Therefore, tolerance is established for residues of ziram, zinc dimethyldithiocarbamate, in or on hazelnut at 0.10 ppm.

In addition, EPA is making a number of housekeeping adjustments to this rule. First, consistent with the Agency's policy for drafting the tolerance expression, EPA is revising the tolerance expression to clarify that the tolerance covers residues of the parent as well as metabolites and degradates of the pesticide chemical in accordance with section 408(a)(3) of the FFDCA, and to clarify how residues of the chemical are to be measured to determine compliance with the tolerance levels. Second, because the tolerance for blackberries has expired by its terms, EPA is removing that tolerance from section 180.116. Finally, because no current tolerances have an expiration date, the third column is not necessary, so EPA is removing that column.

This action establishes 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 tolerance 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 EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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-2017-0095 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 February 6, 2018. 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-2017-0095, 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 June 8, 2017 (82 FR 26641) (FRL-9961-14), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 6F8536) by E. I. du Pont de Nemours and Company, 974 Centre Road, Wilmington, Delaware 19805. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the insecticide indoxacarb, [(S)-methyl 7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-(trifluoromethoxy)-phenyl] amino]carbonyl]indeno[1,2e] [1,3,4]oxadiazine-4a(3H)-carboxylate], and [(R)-methyl 7 chloro-2,5-dihydro-2[[(methoxycarbonyl)[4-(trifluoromethoxy)phenyl] amino]carbonyl]indeno[1,2-e][1,3,4] oxadiazine-4a(3H)-carboxylate], in or on corn, field, forage at 10 parts per million (ppm); corn, field, stover at 15 ppm; corn, field, aspirated grain fractions at 45 ppm; corn, field flour at 0.07 ppm; corn, field, meal at 0.03 ppm; corn, field, oil at 0.05 ppm; corn, field, grain at 0.02 ppm. That document referenced a summary of the petition prepared by E. I. du Pont de Nemours and Company, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

Based on available information, EPA is establishing some tolerances that vary from what the petitioner requested. The reasons for these changes are discussed in Unit IV.C.

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish 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 . . .”

Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), 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 indoxacarb including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with indoxacarb follows.

EPA has evaluated the available toxicity data and considered its 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.

The most common effects resulting from exposure to indoxacarb (defined by the lowest-observed-adverse-effect-level (LOAEL)) were non-specific, and included decreases in body weight, food consumption, and food efficiency. Indoxacarb also affected the hematopoietic system by decreasing the red blood cell count, hemoglobin, and hematocrit in rats, dogs, and mice.

There was no evidence of reproductive effects in rats resulting from exposure to indoxacarb. There was no evidence of increased susceptibility in developing fetuses or in offspring following prenatal and/or postnatal exposure to indoxacarb in rats or rabbits. There was no evidence of increased susceptibility in the young in the developmental neurotoxicity study in rats. Neurotoxicity was observed in rats and mice, but at doses much higher than those selected for points of departure (PoDs) (which are based on changes in body weight, food consumption and changes in hematology). There is no evidence indoxacarb is carcinogenic, teratogenic, mutagenic, or immunotoxic.

Specific information on the studies received and the nature of the adverse effects caused by indoxacarb as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the documents, Indoxacarb: Human Health Risk Assessment for Indoxacarb to Support the Proposed New Uses on Corn (Field, Pop, and Grown for Seed) in docket ID number EPA-HQ-OPP-2017-0095 and Indoxacarb: Human Health Draft Risk Assessment for Indoxacarb to Support Registration Review and the Proposed New Use for Controlling Ants at Ornamental Nurseries, Sod Farms, and Livestock Corrals of non-Food Bearing Animals in docket ID number EPA-HQ-OPP-2013-0367.

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.

A summary of the toxicological endpoints for indoxacarb used for human risk assessment is shown in Table 1 of this unit.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to indoxacarb, EPA considered exposure under the petitioned-for tolerances as well as all existing indoxacarb tolerances in 40 CFR 180.564. EPA assessed dietary exposures from indoxacarb in food as follows:

i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. Such effects were identified for indoxacarb. In conducting the acute dietary exposure assessment EPA used food consumption information from the 2003-2008 food consumption data from the U.S. Department of Agriculture's (USDA's) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). In estimating acute dietary exposure, EPA used maximum residue levels based on the results of field trials reflecting maximum use patterns in all commodities and used maximum Percent Crop Treated (PCT) estimates.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment, EPA used food consumption information from the 2003-2008 food consumption data from the U.S. Department of Agriculture's (USDA's) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). In estimating chronic dietary exposure, EPA used average residue levels based on the results of field trials reflecting maximum use patterns in all commodities and used average PCT estimates.

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

iv. Anticipated residue and PCT information. Average or maximum residues and PCT values were used for food commodities.

Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must require pursuant to FFDCA section 408(f)(1) that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. For the present action, EPA will issue such data call-ins as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be required to be submitted no later than 5 years from the date of issuance of these tolerances.

Section 408(b)(2)(F) of FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if:

• Condition a: The data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain the pesticide residue.

• Condition b: The exposure estimate does not underestimate exposure for any significant subpopulation group.

• Condition c: Data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area.

In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by FFDCA section 408(b)(2)(F), EPA may require registrants to submit data on PCT.

The Agency estimated maximum and average PCT values for the acute and chronic dietary assessments, as follows:

• For acute dietary assessment: Apples: 10%; apricots: 15%; blueberries: 5%; broccoli: 70%, cabbage: 35%; cantaloupe: 10%; cauliflower: 60%; celery: 5%; cherries: 2.5%; cotton: 2.5%; cucumbers: 10%; grapes: 5%; lettuce: 15%; nectarines: 15%; peaches: 10%; peanuts: 10%; pears: 2.5%; peppers: 30%; plums/prunes: 5%; potatoes: 2.5%; soybeans: 2.5%; spinach: 5%; squash: 5%; sweet corn: 10%; and tomatoes: 40%.

• For chronic dietary assessment: Apples: 5%; apricots: 5%; blueberries: 5% broccoli: 45%, cabbage: 20%; cantaloupe: 5%; cauliflower: 35%; celery: 5%; cherries: 2.5%; cotton: 2.5%; cucumbers: 2.5%; grapes: 2.5%; lettuce: 5%; nectarines: 15%; peaches: 2.5%; peanuts: 5%; pears: 1%; peppers: 15%; plums/prunes: 5%; potatoes: 2.5%; soybeans: 1%; spinach: 2.5%; squash: 2.5%; sweet corn: 2.5%; and tomatoes: 20%.

In most cases, EPA uses available data from United States Department of Agriculture/National Agricultural Statistics Service (USDA/NASS), proprietary market surveys, and the National Pesticide Use Database for the chemical/crop combination for the most recent 6 to 7 years. EPA uses an average PCT for chronic dietary risk analysis. The average PCT figure for each existing use is derived by combining available public and private market survey data for that use, averaging across all observations, and rounding to the nearest 5%, except for those situations in which the average PCT is less than 2.5%. In those cases, estimates of average PCT between 1% and 2.5% are rounded to 2.5% and estimates of average PCT less than 1% are rounded to 1%. EPA uses a maximum PCT for acute dietary risk analysis. The maximum PCT figure is the highest observed maximum value reported within the recent 6 years of available public and private market survey data for the existing use and rounded up to the nearest multiple of 5%, except for those situations in which the maximum PCT is less than 2.5%. In those cases, EPA uses a maximum PCT value of 2.5%.

The Agency believes the three conditions discussed in Unit III.C.1.iv. have been met. With respect to Condition a, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions b and c, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available reliable information on the regional consumption of food to which indoxacarb may be applied in a particular area.

2. Dietary exposure from drinking water. The Agency used screening-level water exposure models in the dietary exposure analysis and risk assessment for indoxacarb in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of indoxacarb. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.

Based on the Surface Water Concentration Calculator (SWCC) model and the Pesticide Root Zone Model Ground Water (PRZM GW), the estimated drinking water concentrations (EDWCs) of indoxacarb for acute exposures are 39 parts per billion (ppb) for surface water and 131 ppb for ground water; for chronic exposures the EDWCs are 11 ppb for surface water and 123 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For the acute dietary risk assessment, a time series distribution of ground water modeled residues was used to assess the contribution to drinking water. For the chronic dietary risk assessment, a single point water concentration value of 123 ppb was used to assess the contribution to drinking water.

3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets).

Indoxacarb is currently registered for the following uses that could result in residential exposures: Pet spot-on uses, spot, crack and crevice applications indoors, outdoor broadcast (i.e., turf), perimeter and foundations, spot (i.e., direct mount applications for fire ants), and crack and crevice.

Based on these use scenarios, EPA assessed residential exposure using the following assumptions:

• Spot and crack and crevice exposures were not assessed due to formulation types that minimize the potential for handler and post-application exposures (i.e., gels or bait stations). Risks from spot and crack and crevice were not assessed because exposures from these formulation types are expected to be negligible.

• Residential handler exposure: There is a potential for dermal and inhalation exposure. Residential handler inhalation exposure is considered negligible for applying ready-to-use pet spot-ons. Residential handler dermal exposures are expected for ready-to-use pet spot-ons, however dermal exposures were not assessed due to the lack of a dermal endpoint. Residential handler inhalation and dermal exposures are considered negligible for applying ready-to-use arenas (i.e., baits or stations).

• Residential post-application dermal and incidental oral exposure: Post-application assessments were not conducted for ant mound uses, because these are considered perimeter/spot uses; residential exposure is expected to be negligible. Spot and crack and crevice exposures were not assessed for gels or bait stations; exposure is considered negligible. A golfer assessment was not conducted, due to the lack of a dermal endpoint. Post-application inhalation exposure is generally not assessed following application to pets and turf. The combination of low vapor pressure (1.9x10-10 mm Hg at 25 ºC for indoxacarb) of active ingredients typically used in pet and turf pesticide products, and the small amounts of pesticide applied to pets is expected to result in only negligible inhalation exposure. Ingestion of granules is considered an episodic event and not a routine behavior. Because the Agency does not expect this to occur on a regular basis, concern for human health is related to acute poisoning rather than short-term residue exposure. For these reasons, the episodic ingestion scenario is not included in the aggregate assessment. The only route of residential exposure for inclusion in the adult aggregate assessment is inhalation. However, inhalation exposures cannot be aggregated with background dietary exposures because the toxicity endpoints for the inhalation and short-term oral routes are different. Therefore, the only residential exposures that were combined are for children 1 to <2 years old in the short-term aggregate assessment that reflects hand-to-mouth exposures from post-application exposure to spot treatment on carpets, and children 1 to <2 years old in the intermediate- and long-term aggregate assessment that reflects exposures from treated pets.

Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.

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 indoxacarb to share a common mechanism of toxicity with any other substances, and indoxacarb does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA assumed that indoxacarb 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 10 times;, 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 was no evidence of reproductive effects in rats. There was no evidence of increased susceptibility in developing fetuses or in the offspring following prenatal and/or postnatal exposure to indoxacarb in rats or rabbits. There was no evidence of increased susceptibility in the young in the developmental neurotoxicity study in rats.

3. Conclusion. EPA determined 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 indoxacarb is complete.

ii. The acute neurotoxicity, subchronic toxicity, and developmental neurotoxicity studies for indoxacarb are available and all endpoints used in the risk assessment are protective of neurotoxic effects.

iii. There is no evidence that indoxacarb results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study.

iv. There are no residual uncertainties identified in the exposure databases. The Agency estimated maximum and average PCT values for the acute and chronic dietary assessments, respectively, as shown in unit III.C.i., and unit III.C.ii.

Food residues were taken from the results of supervised field trial studies reflecting maximum use patterns. Drinking water residues were included in the dietary assessments as follows: A point estimate of 123 ppb was used for the chronic assessment and the time series distribution of ground water modeled residues was used in the acute assessment as a residue distribution file (RDF) in the Monte Carlo analysis. For food commodities, RDFs were constructed for the probabilistic acute dietary assessment as appropriate, and average residues were computed for blended commodities and for the chronic dietary assessment.

EPA used similarly conservative assumptions to assess post-application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by indoxacarb.

EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (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. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to indoxacarb will occupy 56% of the aPAD for children ages 1-2, the population group receiving the greatest exposure.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to indoxacarb from food and water will utilize 35% of the cPAD for all infants less than 1-year old, the population group receiving the greatest exposure. EPA has concluded the combined long-term food, water, and residential exposures result in aggregate MOEs of 260 (food, water, and residential) for children aged 1-2. Because EPA's level of concern for indoxacarb is a MOE of 100 or below, this MOEs is not of concern. For adults, residential inhalation exposures cannot be aggregated because they are based on different effects than for oral exposures. Therefore, long-term aggregate risk for adults is equivalent to the chronic dietary risk noted in this unit.

3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Indoxacarb is currently registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure to children aged 1-2 years through food and water with short-term residential exposures to indoxacarb. For adults, residential inhalation exposures cannot be aggregated because they are based on different effects than for oral exposures. Therefore, short-term aggregate risk for adults is equivalent to the chronic risk noted in unit III.E.2.

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 120 (food, water, and residential) for children aged 1-2. Because EPA's level of concern for indoxacarb is a MOE of 100 or below, this MOEs is not of concern.

4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Indoxacarb is currently registered for uses that could result in intermediate-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure to children aged 1-2 years through food and water with intermediate-term residential exposures to indoxacarb. For adults, residential inhalation exposures cannot be aggregated because they are based on different effects than for oral exposures. Therefore, intermediate-term aggregate risk for adults is equivalent to the chronic risk noted above in unit III.E.2.

Using the exposure assumptions described in this unit for intermediate-term exposures, EPA has concluded that the combined intermediate-term food, water, and residential exposures for children aged 1-2 years result in aggregate MOEs of 260. Because EPA's level of concern for indoxacarb is a MOE of 100 or below, this MOE is not of concern.

5. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, indoxacarb is not expected to pose a cancer risk to humans.

6. 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 indoxacarb residues.

For the enforcement of tolerances established on crops, two High Performance Liquid Chromatograph/Ultraviolet Detection (HPLC/UV) methods, DuPont protocols AMR 2712-93 and DuPont-11978, are available for use. The limits of quantitation (LOQs) for these methods range from 0.01 to 0.05 ppm for a variety of plant commodities. A third procedure, Gas Chromatograph/Mass-Selective Detection (GC/MSD), DuPont method AMR 3493-95 Supplement No. 4, is also available for the confirmation of residues in plants.

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

The Codex has not established MRLs in field corn for indoxacarb.

Based on available data and using the Organisation for Economic Co-operation and Development (OECD) maximum residue limit (MRL) calculation procedures, EPA determined that the appropriate tolerance level for corn, field, forage is 6.0 ppm. Based on the corn processing studies, the Agency determined that there is a low level of residue concentration from processing; therefore, separate tolerances are not needed for the processed corn commodities of flour, meal, or oil because these commodities are covered by the tolerance for corn, field, grain. The “grain, aspirated fractions” tolerance does not need to be modified for field corn because 40 CFR 180.564(a) currently lists a tolerance level of 45 ppm for “grain, aspirated fractions,” and this tolerance covers potential indoxacarb residues in aspirated grain fractions derived from corn.

Therefore, tolerances are established for residues of indoxacarb, [(S)-methyl 7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-(trifluoromethoxy)-phenyl] amino]carbonyl] indeno[1,2e][1,3,4]oxadiazine-4a(3H)-carboxylate], and [(R)-methyl 7 chloro-2,5-dihydro-2[[(methoxycarbonyl)[4-(trifluoromethoxy)phenyl] amino]carbonyl] indeno [1,2-e][1,3,4] oxadiazine-4a(3H)-carboxylate], in or on corn, field, forage at 6.0 ppm; corn, field, stover at 15 ppm; and corn, field, grain at 0.02 ppm.

This action establishes tolerances 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 tolerance 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 EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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-2016-0537 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 February 6, 2018. 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-2016-0537, 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 November 30, 2016 (81 FR 86312) (FRL-9954-06), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 6F8458) by Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, NC 27419. The petition requested that 40 CFR 180.665 be amended by establishing tolerances for residues of the fungicide sedaxane, in or on grain, cereal, forage, fodder and straw, group 16 at 0.06 parts per million (ppm); grain, cereal, group 15 at 0.01 ppm; peanut at 0.01 ppm; and peanut, hay at 0.08 ppm. The petition also requested that tolerances for residues of sedaxane on the following commodities be removed upon the establishment of the petitioned-for tolerances: barley, grain at 0.01 ppm; barley, hay at 0.04 ppm; barley, straw at 0.01 ppm; corn, field, forage at 0.01 ppm; corn, field, grain at 0.01 ppm; corn, field, stover at 0.01 ppm; corn, pop, grain at 0.01 ppm; corn, pop, stover at 0.01 ppm; corn, sweet, forage at 0.01 ppm; corn, sweet, kernel plus cob with husks removed at 0.01 ppm; corn, sweet, stover at 0.01 ppm; oat, forage at 0.015 ppm; oat, grain at 0.01 ppm; oat, hay at 0.06 ppm; oat, straw at 0.01 ppm; rye, forage at 0.015 ppm; rye, grain at 0.01 ppm; rye, straw at 0.01 ppm; sorghum, grain, forage at 0.01 ppm; sorghum, grain, grain at 0.01 ppm; sorghum, grain, stover at 0.01 ppm; wheat, forage at 0.015 ppm; wheat, grain at 0.01 ppm; wheat, hay at 0.06 ppm; and wheat, straw at 0.01 ppm. That document referenced a summary of the petition prepared by Syngenta Crop Protection, LLC, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

Based upon review of the data supporting the petition, EPA is establishing tolerances and removing tolerances as requested in the petition, with one exception. The tolerance for crop group 16 is being established at 0.10 ppm to harmonize with Codex Alimentarius Commission maximum residue level (MRL).

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish 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. . . .”

Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), 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 sedaxane including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with sedaxane follows.

EPA has evaluated the available toxicity data and considered its 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.

The main target tissue for sedaxane was found to be the liver. Sedaxane also caused thyroid hypertrophy/hyperplasia in male rats. In the acute neurotoxicity (ACN) and sub-chronic neurotoxicity (SCN) studies, sedaxane caused decreased activity, muscle tone, rearing and grip strength; however, because no specific neurotoxic effects or adverse histopathology were observed, EPA has concluded that there is low concern for neurotoxicity.

In the rat, no adverse effects in fetuses were seen in developmental toxicity studies at maternally toxic doses. In the rabbit, fetal toxicity was observed at the same doses as the dams. Offspring effects in the rat reproduction study occurred at the same doses causing parental effects.

The available data show evidence of high dose liver tumors (in male rats and mice), thyroid tumors (in male rats), and uterine tumors (in female rats) resulting from exposure to sedaxane. Based on a weight of evidence of the available data, a constitutive androstane receptor/pregnane-X receptor (CAR/PXR)-mediated mitogenic mode-of action (MOA) was established for liver tumors in male mice and rats and a liver-mediated altered thyroid hormone homeostasis MOA was established for thyroid tumors in male rats. At this time, a MOA for the uterine tumors has not been identified.

To assess the carcinogenic potential for sedaxane, EPA has concluded that a non-linear approach (i.e., RfD) is appropriate for the following reasons: (1) There is a clear understanding of the threshold (non-linear) doses associated with the key events in the established MOAs leading to liver and thyroid tumors in rodents (the key events occur only at doses that well exceed the chronic reference dose (0.11 mg/kg/day)); (2) sedaxane is not mutagenic or genotoxic; (3) the dose at which uterine tumors was observed is at 261 mg/kg/day, which greatly exceeds the chronic reference dose (0.11 mg/kg/day) being used to assess chronic exposure to sedaxane. Sedaxane has been reclassified as “Suggestive Evidence of Carcinogenic Potential”.

Sedaxane has low acute toxicity by the oral, dermal, and inhalation routes. It is not a dermal sensitizer, causes no skin irritation, and only slight eye irritation.

Specific information on the studies received and the nature of the adverse effects caused by sedaxane as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document titled “Sedaxane Human Health Risk Assessment to Support New Seed Treatment Uses on Cereal Grains Crop Group 15; Forage, Fodder and Straw of Cereal Grains Crop Group 16; Peanut; and Cancer Reclassification”, pages 11-19 in docket ID number EPA-HQ-OPP-2016-0537.

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/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.

A summary of the toxicological endpoints for sedaxane used for human risk assessment is shown in the Table of this unit.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to sedaxane, EPA considered exposure under the petitioned for tolerances as well as all existing sedaxane tolerances in 40 CFR 180.665. EPA assessed dietary exposures from sedaxane in food as follows:

i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure.

Such effects were identified for sedaxane. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) under the Continuing Surveys of Food Intake by Individuals (CSFII) and the CDC under the National Health and Nutrition Examination Survey What We Eat in America (NHANES/WEIA) 2003-2008. EPA assumed tolerance-level residues for all commodities and 100% crop treated. Default processing factors were used with the exception of peanut butter.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA NHANES/WEIA 2003-2008. EPA assumed tolerance-level residues for all commodities and 100% crop treated (CT). Default processing factors were used with the exception of peanut butter.

iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that a nonlinear RfD approach is appropriate for assessing cancer risk to sedaxane. Cancer risk was assessed using the same exposure estimates as discussed in Unit III.C.1.ii.

iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use anticipated residue and/or PCT information in the dietary assessment for sedaxane. Tolerance-level residues and/or 100% CT were assumed for all food commodities.

2. Dietary exposure from drinking water. The Agency used screening-level water exposure models in the dietary exposure analysis and risk assessment for sedaxane in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of sedaxane. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.

Based on the FQPA Index Reservoir Screening Tool (FIRST) and Pesticide Root Zone Model Ground Water (PRZM GW), the estimated drinking water concentrations (EDWCs) of sedaxane for acute exposures are estimated to be 4.1 parts per billion (ppb) for surface water and 15.1 ppb for ground water and for chronic exposures for non-cancer assessments are estimated to be 1.2 ppb for surface water and 13.0 ppb for ground water. The surface water estimates include contributions from all drinking water residues of concern identified for risk assessment purposes; nevertheless, the ground water EDWCs were higher than the surface water EDWCs and were selected for use in the dietary exposure assessments.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 15.1 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 13.0 ppb was used to assess the contribution to drinking water.

3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Sedaxane is not registered 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.”

Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to sedaxane and any other substances, and sedaxane does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that sedaxane 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 https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

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. There is no evidence for increased susceptibility following prenatal or post-natal exposures to sedaxane based on effects seen in developmental toxicity studies in rabbits or rats. In range-finding and definitive developmental toxicity studies in rats, neither quantitative nor qualitative evidence of increased susceptibility of fetuses to in utero exposure to sedaxane was observed. In these studies, there were no single-dose effects. There was no evidence of increased susceptibility in a two-generation reproduction study in rats following prenatal or post-natal exposure to sedaxane. There was no evidence of neuropathology or abnormalities in the development of the fetal nervous system from the available toxicity studies conducted with sedaxane. Clear NOAELs/LOAELs were established for the developmental effects seen in rats and rabbits as well as for the offspring effects seen in the two-generation reproduction study. The dose-response relationship for the effects of concern is well characterized.

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 sedaxane is complete.

ii. Given the available information, there is low concern that sedaxane is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional uncertainty factors (UFs) to account for neurotoxicity.

iii. In the rat, no adverse effects in fetuses were seen in developmental toxicity at maternally toxic doses. In the rabbit, fetal toxicity was observed at the same doses as the dam (increased unossified sternebrae and 13th rudimentary ribs and a decrease in fetal weights of −9% and increased abortions). In the dam, at the same doses, the effects were decreased body weight, reduced food consumption, and decreased defecation. In reproduction studies, offspring effects occurred at the same doses causing parental effects; thus, there was no quantitative increase in sensitivity in rat pups. The LOAELs and NOAELs for the developmental and reproduction studies were clearly defined. The NOAEL used for the acute dietary risk assessment (30 mg/kg/day), based on effects observed in the ACN study, is protective of the developmental and offspring effects seen in rabbits and rats with the NOAELs of 100-200 mg/kg/day. Based on these considerations, there are no residual uncertainties for pre-and/or post-natal susceptibility.

iv. There were no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100% CT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to sedaxane in drinking water. These assessments will not underestimate the exposure and risks posed by sedaxane.

EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (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. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to sedaxane will occupy <1% of the aPAD for all infants (<1-year-old), the population group receiving the greatest exposure.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to sedaxane from food and water will utilize <1% of the cPAD for all population subgroups. There are no residential uses for sedaxane.

3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Because there are no proposed or registered residential uses of sedaxane, a short-term risk assessment was not performed. The chronic risk assessment is protective for any short-term exposures from food and drinking water.

4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Because there are no proposed or registered residential uses of sedaxane, an intermediate-term risk assessment was not performed. The chronic risk assessment is protective for any intermediate-term exposures from food and drinking water.

5. Aggregate cancer risk for U.S. population. As discussed in Unit III.A., EPA has concluded that using the nonlinear approach based on the chronic RfD will be protective of potential carcinogenicity.

6. 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 sedaxane residues.

An adequate analytical method is available to enforce the proposed tolerances for sedaxane in plant commodities. A modification of the Quick, Easy, Cheap, Effective, Rugged, and Safe (QuEChERS) method was developed for the determination of residues of sedaxane (as its isomers SYN508210 and SYN508211) in/on various crops. The sedaxane isomers (SYN508210 and SYN508211) are quantitatively determined by LC/MS/MS. The validated limit of quantitation (LOQ) reported in the method is 0.005 ppm for both sedaxane isomers.

The analytical standard for sedaxane, with an expiration date of February 28, 2018, is currently available in the EPA National Pesticide Standards Repository.

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international MRL established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

Codex has established MRLs for sedaxane in or on grain, cereal, forage, fodder and straw, group 16 at 0.10 ppm and grain, cereal, group 15 at 0.01 ppm. Codex has not established a MRL for sedaxane in or on peanut. Tolerances are harmonized with the Codex MRLs for groups 16 and 15.

Therefore, tolerances are established for residues of sedaxane in or on grain, cereal, forage, fodder and straw, group 16 at 0.10 ppm; grain, cereal, group 15 at 0.01 ppm; peanut at 0.01 ppm; and peanut, hay at 0.08 ppm. In addition, EPA is removing the following existing tolerances for residues of sedaxane as they are superseded by the tolerances established in this rulemaking: Barley, grain at 0.01 ppm; barley, hay at 0.04 ppm; barley, straw at 0.01 ppm; corn, field, forage at 0.01 ppm; corn, field, grain at 0.01 ppm; corn, field, stover at 0.01 ppm; corn, pop, grain at 0.01 ppm; corn, pop, stover at 0.01 ppm; corn, sweet, forage at 0.01 ppm; corn, sweet, kernel plus cob with husks removed at 0.01 ppm; corn, sweet, stover at 0.01 ppm; oat, forage at 0.015 ppm; oat, grain at 0.01 ppm; oat, hay at 0.06 ppm; oat, straw at 0.01 ppm; rye, forage at 0.015 ppm; rye, grain at 0.01 ppm; rye, straw at 0.01 ppm; sorghum, grain, forage at 0.01 ppm; sorghum, grain, grain at 0.01 ppm; sorghum, grain, stover at 0.01 ppm; wheat, forage at 0.015 ppm; wheat, grain at 0.01 ppm; wheat, hay at 0.06 ppm; and wheat, straw at 0.01 ppm.

This action establishes tolerances 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 tolerance 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:

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 Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

Under FFDCA section 408(g), 21 U.S.C. 346a(g), 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-2016-0687 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 February 6, 2018. 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-2016-0687, 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 February 7, 2017 (82 FR 9555) (FRL-9956-86), 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 6F8490) by BASF Corporation, 26 Davis Dr., P.O. Box 13528, Research Triangle Park, NC 27709. The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of the fungicide Bacillus subtilis strain BU1814 in or on all food commodities. That document referenced a summary of the petition prepared by the petitioner BASF Corporation, which is available in the docket via 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 require EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance or tolerance exemption 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 . . . .” Additionally, FFDCA section 408(b)(2)(D) requires that EPA consider “available information concerning the cumulative effects of [a particular pesticide's] . . . residues and other substances that have a common mechanism of toxicity.”

EPA evaluated the available toxicity and exposure data on Bacillus subtilis strain BU1814 and considered its validity, completeness, and reliability, as well as the relationship of this information to human risk. A full explanation of the data upon which EPA relied and its risk assessment based on those data can be found within the document entitled “Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for Bacillus subtilis strain BU1814.” This document, as well as other relevant information, is available in the docket for this action as described under ADDRESSES. The available data indicate that Bacillus subtilis strain BU1814 showed no toxicity, no pathogenicity, and no infectivity via the acute oral, pulmonary, and intravenous routes of exposure. Based upon its evaluation, EPA concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of Bacillus subtilis strain BU1814. Therefore, an exemption from the requirement of a tolerance is established for residues of Bacillus subtilis strain BU1814 in or on all food commodities when used in accordance with label directions and good agricultural practices.

An analytical method is not required because EPA is establishing an exemption from the requirement of a tolerance without any numerical limitation.

This action establishes a tolerance exemption under FFDCA section 408(d) in response to a petition submitted to EPA. 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 tolerance exemption in this action, 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. As a result, this action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, EPA 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, EPA 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 EPA's 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. Does this action apply to me?

A list of potentially affected entities is provided in the Federal Register of October 25, 2017 (82 FR 49287). If you have questions regarding the applicability of this action to a particular entity, consult the technical person listed under FOR FURTHER INFORMATION CONTACT.

In the October 25, 2017 Federal Register, EPA published both a direct final rule (see 82 FR 49287) and proposed rule (see 82 FR 49302) (FRL-9962-80) pursuant to section 601 of TSCA that would have updated several of the voluntary consensus standards incorporated by reference at § 770.99 as published on December 12, 2016 (see 81 FR 89674) (FRL-9949-90). These voluntary consensus standards have been updated, withdrawn, or superseded since publication of the original final rule in 2016. Additionally, the direct final rule would have amended testing requirements for demonstration of equivalence and correlation between approved quality control test methods and either the ASTM E1333-14 test chamber, or, upon showing equivalence in accordance with § 770.20(d), the ASTM D6007-14 test chamber under § 770.20(d)(2)(i).

Since the direct final rule and proposed rule's publication, EPA has received a comment on the proposed amendments to the voluntary consensus standard updating action that the Agency considers to be adverse. As a result of receiving an adverse comment, EPA is withdrawing the direct final rule published in the Federal Register on October 25, 2017. All comments are available for review in the public docket. EPA will address the public comments received on this action in a subsequent final rule.

To access the docket, please go to http://www.regulations.gov and follow the online instructions using the docket ID number EPA-HQ-OPPT-2017-0245. Additional information about the Docket Facility is also provided under ADDRESSES in the October 25, 2017 (82 FR 49287) Federal Register document. If you have questions, consult the technical person listed under FOR FURTHER INFORMATION CONTACT.

EPA finds that there is “good cause” under the Administrative Procedure Act (5 U.S.C. 553(b)(3)(B)) to withdraw the direct final rule discussed in this document without prior notice and comment. For this document, notice and comment is impracticable and unnecessary because EPA is under a time limit to publish this withdrawal. It was determined that this document is not subject to the 30-day delay of effective date generally required by 5 U.S.C. 553(d) as there is good cause for the withdrawal to be effective immediately. This withdrawal must become effective prior to the effective date of the direct final rule being withdrawn, as EPA explained in the direct final rule itself.

This document withdraws regulatory requirements that have not gone into effect. As such, the Agency has determined that this withdrawal will not have any adverse impacts, economic or otherwise. The statutory and Executive Order review requirements applicable to the direct final rule being withdrawn were discussed in the October 25, 2017 (82 FR 49287) Federal Register document. Those review requirements do not apply to this action because it is a withdrawal and does not contain any new or amended requirements.

Pursuant to the CRA (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). Section 808 of the CRA allows the issuing agency to make a rule effective sooner than otherwise provided by CRA if the agency makes a good cause finding that notice and public procedure is impracticable, unnecessary, or contrary to the public interest. As required by 5 U.S.C. 808(2), this determination is supported by a brief statement in Unit IV.

Executive Summary

The CSB published an interim final FOIA rule in the Federal Register on September 29, 2017, 82 FR 45502. As an interim final rule, the rule became effective immediately upon publication in the Federal Register. Nonetheless, the CSB welcomed public comments from interested persons regarding the interim final rule. The due date for comments ended on October 30, 2017. The CSB did not receive any comments on the interim final rule. The CSB has determined that no further revisions are required to the interim final rule. Therefore, the CSB now issues this final rule to confirm that the interim final rule published previously shall be the final CSB FOIA rule. The interim final rule published September 29, 2017, 82 FR 45502, will be codified at 40 CFR part 1601 at the next regular update to the Code of Federal Regulations.

The CSB's previous implementation of this rule as an interim final rule, with provision for post-promulgation public comment, was based on section 553(b) of the Administrative Procedure Act. 5 U.S.C. 553(b). Under section 553(b), an agency may issue a rule without notice of proposed rulemaking and the pre-promulgation opportunity for public comment, with regard to “interpretative rules, general statements of policy, or rules of agency organization, procedure, or practice.” The CSB determined that many of the revisions were to interpretive rules issued by the CSB. Moreover, the CSB determined that the remaining revisions were rules of agency procedure or practice, as they did not change the substantive standards the agency applies in implementing the FOIA. The CSB also concluded that a pre-publication public comment period was unnecessary. The revisions in 40 CFR part 1601 merely implemented statutory changes, aligned the CSB's regulations with controlling judicial decisions, and clarified agency procedures.

This rule is not subject to the Unfunded Mandates Reform Act because it does not contain a Federal mandate that may result in the expenditure by state, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000.00 or more in any one year. Nor will it have a significant or unique effect on small governments.

This rule is not subject to the Regulatory Flexibility Act. The CSB has reviewed this regulation and by approving it certifies that this regulation will not have a significant economic impact on a substantial number of small entities. The rule implements the procedures for processing FOIA requests within the CSB. Under the FOIA, agencies may recover only the direct costs of searching for, reviewing, and duplicating the records processed for the requesters. Thus, fees accessed by CSB will be nominal. Further, the “small entities” that make FOIA requests, as compared with individual and other requesters, are relatively few in number.

This rule does not impose reporting or recordkeeping requirements under the Paperwork Reduction Act of 1995. The Paperwork Reduction Act imposes certain requirements on Federal agencies in connection with the conducting or sponsoring of any collection of information. This rule does not contain any new collection of information requirement within the meaning of the Act.

This rule is not a major rule as defined by section 251 of the Small Business Regulatory Enforcement Fairness Act of 1996 (as amended), 5 U.S.C. 804. This rule will not result in an annual effect on the economy of $100,000,000.00 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 enterprises to compete with foreign-based enterprises in domestic and export markets.

This rule will not have a significant effect on the human environment. Accordingly, this rule is categorically excluded from environmental analysis under 43 CFR 46.210(i).

Section 206 of the E-Government Act requires agencies, to the extent practicable, to ensure that all information about that agency required to be published in the Federal Register is also published on a publicly accessible Web site. All information about the CSB required to be published in the Federal Register may be accessed at http://www.csb.gov/. The E-Government Act also requires, to the extent practicable, that agencies ensure that a publicly accessible Federal Government Web site contains electronic dockets for rulemakings under the Administrative Procedure Act of 1946 (5 U.S.C. 551 et seq.). Under this Act, an electronic docket consists of all submissions under section 553(c) of title 5, United States Code; and all other materials that by agency rule or practice are included in the rulemaking docket under section 553(c) of title 5, United States Code, whether or not submitted electronically. The Web site http://www.csb.gov/ will contain an electronic dockets for this rulemaking.

Under this Act, the term “plain writing” means writing that is clear, concise, well-organized, and follows other best practices appropriate to the subject or field and intended audience. To ensure that this rulemaking was written in plain and clear language so that it can be used and understood by the public, the CSB modeled the language of this rule on the Federal Plain Language Guidelines.

Accordingly, the interim rule amending 40 CFR part 1601, which was published at 82 FR 45502 on September 29, 2017, is adopted as final without change.

This is a summary of the Commission's Report and Order (R&O), FCC 17-137, adopted and released on October 24, 2017. The full text of this document is available for public inspection and copying during regular business hours in the FCC Reference Center, Federal Communications Commission, 445 12th Street SW., Room CY-A257, Washington, DC 20554. This document will also be available via ECFS at http://fjallfoss.fcc.gov/ecfs/. Documents will be available electronically in ASCII, Microsoft Word, and/or Adobe Acrobat. Copies of the materials can be obtained from the FCC's Reference Information Center at (202) 418-0270. Alternative formats are available for people with disabilities (Braille, large print, electronic files, audio format), by sending an email to [email protected] or calling the Commission's Consumer and Governmental Affairs Bureau at (202) 418-0530 (voice), (202) 418-0432 (TTY).

1. The Commission in this R&O adopts the proposal in the Notice of Proposed Rulemaking (NPRM), 82 FR 25590 (June 2, 2017), to eliminate the Commission rule requiring AM, FM, and television broadcast stations to maintain a local main studio.1 We also adopt the proposal to eliminate the associated staffing and program origination capability requirements that apply to main studios. To ensure that community members retain the ability to communicate with and obtain information regarding their local stations, we retain the existing requirement that broadcasters maintain a local or toll-free telephone number. We also require stations to maintain any portion of their public file that is not part of the online public file at a publicly accessible location within the station's community of license. Finally, we make conforming edits to other Commission rules that are necessitated by the elimination of the main studio rule.

2. We agree with the vast majority of commenters 2 in this proceeding that the main studio rule should be eliminated. We are persuaded that eliminating the rule will result in significant cost savings for broadcasters and other public interest benefits. For example, the record shows that in some small towns and rural areas the cost of complying with the current main studio rule dissuades broadcasters from launching a station, even if the broadcaster has already obtained a construction permit for the station. Eliminating the rule thus may lead to increased broadcast service in those areas. In addition, as commenters suggest, eliminating the main studio rule will provide broadcasters with the same flexibility as Internet radio stations and cable and satellite providers, none of which are subject to a main studio requirement. While we recognize the importance of local broadcast television and radio stations as a source of news and information, we agree with NAB that the record does not provide any “evidence that the physical location of a station's main studio is the reason local broadcasters are able to deliver content that meets the needs and interest[s] of their communities, or that the location and staffing of the studio has any relationship to the ability of a station to serve its local audience.”

3. We affirm the tentative conclusion in the NPRM that technological innovations have rendered local studios unnecessary as a means for viewers and listeners to communicate with or access their local stations and to carry out the other traditional functions that they have served. The record shows that it is exceedingly rare for a member of the public to visit a station's main studio, with community members overwhelmingly choosing instead to communicate with stations through more efficient means such as email, station Web sites, social media, mail, or telephone.3 This has been the case even more so since the Commission created the online public inspection file. Once broadcasters fully transition to the online public file in early 2018, requiring stations to maintain a fully staffed main studio for purposes of providing access to the file will no longer be practical or justifiable. It is also relevant that community members already participate in station shows from outside the main studio, for example by appearing via telephone or Skype. As some commenters state, in-person visits from community members are now “unnecessary, if not obsolete,” as a result of the “near ubiquity of remote communication.” 4

Regulations implemented under the authority of the Atlantic Tunas Convention Act (ATCA; 16 U.S.C. 971 et seq.) and the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act; 16 U.S.C. 1801 et seq.) governing the harvest of BFT by persons and vessels subject to U.S. jurisdiction are found at 50 CFR part 635. Section 635.27 subdivides the U.S. BFT quota recommended by the International Commission for the Conservation of Atlantic Tunas (ICCAT) among the various domestic fishing categories, per the allocations established in the 2006 Consolidated Highly Migratory Species Fishery Management Plan (2006 Consolidated HMS FMP) (71 FR 58058, October 2, 2006) and amendments.

NMFS is required, under § 635.28(a)(1), to file a closure notice with the Office of the Federal Register for publication when a BFT quota (or subquota) is reached or is projected to be reached. On and after the effective date and time of such notification, for the remainder of the fishing year or for a specified period as indicated in the notification, retaining, possessing, or landing BFT under that quota category is prohibited until the opening of the subsequent quota period or until such date as specified in the notice.

The base quota for the General category is 466.7 mt. See § 635.27(a). To date this year, NMFS has adjusted the General category base quota for 2017 three times, including a transfer of 40 mt from the Reserve category effective March 2 (82 FR 12747, March 7, 2017), a transfer of 156.4 mt from the Reserve category effective September 28 (82 FR 46000, October 3, 2017), and a transfer of 25.6 mt from the Harpoon category effective December 1 (82 FR 55520, November 22, 2017). The third transfer resulted in an adjusted General category December subquota of 12.7 mt and an adjusted 2017 General category quota of 688.7 mt.

Based on the best available landings information for the General category BFT fishery, NMFS has determined that the available December subquota of 12.7 mt has been reached, as has the overall adjusted General category quota of 688.7 mt. Therefore, retaining, possessing, or landing large medium or giant BFT by persons aboard vessels permitted in the Atlantic tunas General and HMS Charter/Headboat categories must cease at 11:30 p.m. local time on December 6, 2017. The General category will reopen automatically on January 1, 2018, for the January through March 2018 subperiod. This action applies to Atlantic tunas General category (commercial) permitted vessels and Highly Migratory Species (HMS) Charter/Headboat category permitted vessels and is taken consistent with the regulations at § 635.28(a)(1). The intent of this closure is to prevent overharvest of the available 2017 General category quota.

Fishermen may catch and release (or tag and release) BFT of all sizes, subject to the requirements of the catch-and-release and tag-and-release programs at § 635.26. All BFT that are released must be handled in a manner that will maximize their survival, and without removing the fish from the water, consistent with requirements at § 635.21(a)(1). For additional information on safe handling, see the “Careful Catch and Release” brochure available at www.nmfs.noaa.gov/sfa/hms/.

NMFS will continue to monitor the BFT fisheries closely. Dealers are required to submit landing reports within 24 hours of a dealer receiving BFT. Late reporting by dealers compromises NMFS' ability to timely implement actions such as quota and retention limit adjustment, as well as closures, and may result in enforcement actions. General and Charter/Headboat category vessel owners are required to report the catch of all BFT retained or discarded dead, within 24 hours of the landing(s) or end of each trip, by accessing hmspermits.noaa.gov or by using the HMS Catch Reporting App.

The Assistant Administrator for NMFS (AA) finds that it is impracticable and contrary to the public interest to provide prior notice of, and an opportunity for public comment on, this action for the following reasons:

The regulations implementing the 2006 Consolidated HMS FMP and amendments provide for inseason retention limit adjustments and fishery closures to respond to the unpredictable nature of BFT availability on the fishing grounds, the migratory nature of this species, and the regional variations in the BFT fishery. These fisheries are currently underway and delaying this action would be contrary to the public interest as it could result in excessive BFT landings that may result in future potential quota reductions for the General category. NMFS must close the General category fishery for 2017 to prevent overharvest of the available quota. Therefore, the AA finds good cause under 5 U.S.C. 553(b)(B) to waive prior notice and the opportunity for public comment. For all of the above reasons, there is good cause under 5 U.S.C. 553(d) to waive the 30-day delay in effectiveness.

This action is being taken under § 635.28(a)(1) (BFT Fishery Closures), and is exempt from review under Executive Order 12866.