Federal Register Vol. 80, No.203,

In accordance with section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were not in commercial distribution before May 28, 1976 (the date of enactment of the Medical Device Amendments of 1976), generally referred to as postamendments devices, are classified automatically by statute into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval, unless and until the device is classified or reclassified into class I or II, or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.

Section 513(f)(2) of the FD&C Act, as amended by section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144), provides two procedures by which a person may request FDA to classify a device under the criteria set forth in section 513(a)(1). Under the first procedure, the person submits a premarket notification under section 510(k) of the FD&C Act for a device that has not previously been classified and, within 30 days of receiving an order classifying the device into class III under section 513(f)(1) of the FD&C Act, the person requests a classification under section 513(f)(2). Under the second procedure, rather than first submitting a premarket notification under section 510(k) of the FD&C Act and then a request for classification under the first procedure, the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence and requests a classification under section 513(f)(2) of the FD&C Act. If the person submits a request to classify the device under this second procedure, FDA may decline to undertake the classification request if FDA identifies a legally marketed device that could provide a reasonable basis for review of substantial equivalence with the device or if FDA determines that the device submitted is not of “low-moderate risk” or that general controls would be inadequate to control the risks and special controls to mitigate the risks cannot be developed.

In response to a request to classify a device under either procedure provided by section 513(f)(2) of the FD&C Act, FDA will classify the device by written order within 120 days. This classification will be the initial classification of the device.

On November 6, 2013, HeartFlow, Inc. submitted a request for classification of the FFRCT v.1.4 under section 513(f)(2) of the FD&C Act. The manufacturer recommended that the device be classified into class II (Ref. 1).

In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1). FDA classifies devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use. After review of the information submitted in the request, FDA determined that the device can be classified into class II with the establishment of special controls. FDA believes these special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the device.

Therefore, on November 26, 2014, FDA issued an order to the requestor classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 870.1415.

Following the effective date of this final classification order, any firm submitting a premarket notification (510(k)) for a coronary vascular physiologic simulation software device will need to comply with the special controls named in this final order.

The device is assigned the generic name coronary vascular physiologic simulation software device, and it is identified as a prescription device that provides simulated functional assessment of blood flow in the coronary vascular system using data extracted from medical device imaging to solve algorithms and yield simulated metrics of physiologic information (e.g., blood flow, coronary flow reserve, fractional flow reserve, myocardial perfusion). A coronary vascular physiologic simulation software device is intended to generate results for use and review by a qualified clinician.

FDA has identified the following risks to health associated with this type of device, as well as the mitigation measures required to mitigate these risks, in table 1.

FDA believes that the following special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness:

• Adequate software verification and validation based on comprehensive hazard analysis with identification of appropriate mitigations, must be performed including:

○ Full characterization of the technical parameters of the software, including any proprietary algorithm(s) used to model the vascular anatomy;

Adequate description of the expected impact of all applicable image acquisition hardware features and characteristics on performance and any associated minimum specifications;

○ Adequate consideration of privacy and security issues in the system design; and

Adequate mitigation of the impact of failure of any subsystem components (e.g., signal detection and analysis, data storage, system communications and cybersecurity) with respect to incorrect patient reports and operator failures.

• Adequate non-clinical performance testing must be provided to demonstrate the validity of computational modeling methods for flow measurement.

• Clinical data supporting the proposed intended use must be provided, including the following:

○ Output measure(s) must be compared to a clinically acceptable method and must adequately represent the simulated measure(s) the device provides in an accurate and reproducible manner;

○ Clinical utility of the device measurement accuracy must be demonstrated by comparison to that of other available diagnostic tests (e.g., from literature analysis);

○ Statistical performance of the device within clinical risk strata (e.g., age, relevant comorbidities, disease stability) must be reported;

○ The dataset must be adequately representative of the intended use population for the device (e.g., patients, range of vessel sizes, imaging device models). Any selection criteria or limitations of the samples must be fully described and justified;

○ Statistical methods must consider the predefined endpoints;

Estimates of probabilities of incorrect results must be provided for each endpoint;

Where multiple samples from the same patient are used, statistical analysis must not assume statistical independence without adequate justification;

The report must provide appropriate confidence intervals for each performance metric;

○ Sensitivity and specificity must be characterized across the range of available measurements;

○ Agreement of the simulated measure(s) with clinically acceptable measure(s) must be assessed across the full range of measurements;

○ Comparison of the measurement performance must be provided across the range of intended image acquisition hardware; and

○ If the device uses a cutoff threshold or operates across a spectrum of disease, it must be established prior to validation and it must be justified as to how it was determined and clinically validated.

• Adequate validation must be performed and controls implemented to characterize and ensure consistency (i.e., repeatability and reproducibility) of measurement outputs;

○ Acceptable incoming image quality control measures and the resulting image rejection rate for the clinical data must be specified;

○ Data must be provided within the clinical validation study or using equivalent datasets demonstrating the consistency (i.e., repeatability and reproducibility) of the output that is representative of the range of data quality likely to be encountered in the intended use population and relevant use conditions in the intended use environment;

Testing must be performed using multiple operators meeting planned qualification criteria and using the procedure that will be implemented in the production use of the device; and

The factors (e.g., medical imaging data set, operator) must be identified regarding which were held constant and which were varied during the evaluation, and a description must be provided for the computations and statistical analyses used to evaluate the data.

• Human factors evaluation and validation must be provided to demonstrate adequate performance of the user interface to allow for users to accurately measure intended parameters, particularly where parameter settings that have impact on measurements require significant user intervention.

• Device labeling must be provided that adequately describes the following:

○ The device's intended use, including the type of imaging data used, what the device measures and outputs to the user, whether the measure is qualitative or quantitative, the clinical indications for which it is to be used, and the specific population for which the device use is intended;

○ Appropriate warnings specifying the intended patient population, identifying anatomy and image acquisition factors that may impact measurement results, and providing cautionary guidance for interpretation of the provided measurements;

○ Key assumptions made in the calculation and determination of simulated measurements;

○ The measurement performance of the device for all presented parameters, with appropriate confidence intervals, and the supporting evidence for this performance. Per-vessel clinical performance, including where applicable localized performance according to vessel and segment, must be included as well as a characterization of the measurement error across the expected range of measurement for key parameters based on the clinical data;

○ A detailed description of the patients studied in the clinical validation (e.g., age, gender, race or ethnicity, clinical stability, current treatment regimen) as well as procedural details of the clinical study (e.g., scanner representation, calcium scores, use of beta-blockers or nitrates); and

○ Where significant human interface is necessary for accurate analysis, adequately detailed description of the analysis procedure using the device and any data features that could affect accuracy of results.

A coronary vascular physiologic simulation software device is not safe for use except under the supervision of a practitioner licensed by law to direct the use of the device. As such, the device is a prescription device and must satisfy prescription labeling requirements (see 21 CFR 801.109, Prescription devices).

Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) of the FD&C Act if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. For this type of device, FDA has determined that premarket notification is necessary to provide reasonable assurance of the safety and effectiveness of the device. Therefore, this device type is not exempt from premarket notification requirements. Persons who intend to market this type of device must submit to FDA a premarket notification, prior to marketing the device, which contains information about the coronary vascular physiologic simulation software device they intend to market.

The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in part 807, subpart E, regarding premarket notification submissions have been approved under OMB control number 0910-0120, and the collections of information in 21 CFR part 801, regarding labeling have been approved under OMB control number 0910-0485.

The following reference has been placed on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday, and is available electronically at http://www.regulations.gov.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 870 is amended as follows:

Coast Guard District Commanders and Captains of the Port (COTP) must be immediately responsive to the safety and security needs within their jurisdiction; therefore, District Commanders and COTPs have been delegated the authority to issue certain local regulations. Safety zones may be established for safety or environmental purposes. A safety zone may be stationary and described by fixed limits or it may be described as a zone around a vessel in motion. Security zones limit access to prevent injury or damage to vessels, ports, or waterfront facilities. Special local regulations are issued to enhance the safety of participants and spectators at regattas and other marine events. Drawbridge operation regulations authorize changes to drawbridge schedules to accommodate bridge repairs, seasonal vessel traffic, and local public events. Regulated Navigation Areas are water areas within a defined boundary for which regulations for vessels navigating within the area have been established by the regional Coast Guard District Commander.

Timely publication of these rules in the Federal Register may be precluded when a rule responds to an emergency, or when an event occurs without sufficient advance notice. The affected public is, however, often informed of these rules through Local Notices to Mariners, press releases, and other means. Moreover, actual notification is provided by Coast Guard patrol vessels enforcing the restrictions imposed by the rule. Because Federal Register publication was not possible before the end of the effective period, mariners were personally notified of the contents of these safety zones, security zones, special local regulations, regulated navigation areas or drawbridge operation regulations by Coast Guard officials on-scene prior to any enforcement action. However, the Coast Guard, by law, must publish in the Federal Register notice of substantive rules adopted. To meet this obligation without imposing undue expense on the public, the Coast Guard periodically publishes a list of these temporary safety zones, security zones, special local regulations, regulated navigation areas and drawbridge operation regulations. Permanent rules are not included in this list because they are published in their entirety in the Federal Register. Temporary rules are also published in their entirety if sufficient time is available to do so before they are placed in effect or terminated.

The following unpublished rules were placed in effect temporarily during the period between January 2015 and March 2015 unless otherwise indicated. To view copies of these rules, visit www.regulations.gov and search by the docket number indicated in the list below.

Coast Guard District Commanders and Captains of the Port (COTPs) must be immediately responsive to the safety and security needs within their jurisdiction; therefore, District Commanders and COTPs have been delegated the authority to issue certain local regulations. Safety zones may be established for safety or environmental purposes. A safety zone may be stationary and described by fixed limits or it may be described as a zone around a vessel in motion. Security zones limit access to prevent injury or damage to vessels, ports, or waterfront facilities. Special local regulations are issued to enhance the safety of participants and spectators at regattas and other marine events. Drawbridge operation regulations authorize changes to drawbridge schedules to accommodate bridge repairs, seasonal vessel traffic, and local public events. Regulated Navigation Areas are water areas within a defined boundary for which regulations for vessels navigating within the area have been established by the regional Coast Guard District Commander.

Timely publication of these rules in the Federal Register may be precluded when a rule responds to an emergency, or when an event occurs without sufficient advance notice. The affected public is, however, often informed of these rules through Local Notices to Mariners, press releases, and other means. Moreover, actual notification is provided by Coast Guard patrol vessels enforcing the restrictions imposed by the rule. Because Federal Register publication was not possible before the end of the effective period, mariners were personally notified of the contents of these safety zones, security zones, special local regulations, regulated navigation areas or drawbridge operation regulations by Coast Guard officials on-scene prior to any enforcement action. However, the Coast Guard, by law, must publish in the Federal Register notice of substantive rules adopted. To meet this obligation without imposing undue expense on the public, the Coast Guard periodically publishes a list of these temporary safety zones, security zones, special local regulations, regulated navigation areas and drawbridge operation regulations. Permanent rules are not included in this list because they are published in their entirety in the Federal Register. Temporary rules are also published in their entirety if sufficient time is available to do so before they are placed in effect or terminated.

The following unpublished rules were placed in effect temporarily during the period between October 2014 and December 2014 unless otherwise indicated. To view copies of these rules, visit www.regulations.gov and search by the docket number indicated in the list below:

The Chicago, Central & Pacific Railroad requested a temporary deviation for the Illinois Central Railroad Drawbridge, across the Upper Mississippi River, mile 579.9, at Dubuque, Iowa to remain in the closed-to-navigation position from 7 a.m. to 12 p.m., on November 5, 2015 to replace the tender house essential to the continued safe operation of the drawbridge.

The Illinois Central Railroad Drawbridge currently operates in accordance with 33 CFR 117.5, which states the general requirement that the drawbridge shall open on signal.

There are no alternate routes for vessels transiting this section of the Upper Mississippi River. The bridge cannot open in case of emergency.

The Illinois Central Railroad Drawbridge provides a vertical clearance of 19.9 feet above normal pool in the closed-to-navigation position. Navigation on the waterway consists primarily of commercial tows and recreational watercraft and will not be significantly impacted. This temporary deviation has been coordinated with waterway users. No objections were received.

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.

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 of an unexpected extension of construction. With construction still in progress the safety zone needs to be extended until November 30, 2015. Due to the nature of the delay and the need to extend the safety zone immediately, it would be impracticable to issue an NPRM and solicit comment before finalizing this rule.

We are issuing this rule, and 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. Delaying the effective date of this rule would be contrary to public interest because immediate action is needed to respond to the potential safety hazards associated with the construction of the east span of the 520 Bridge.

The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The Captain of the Port Puget sound (COTP) has determined that potential hazards associated with bridge construction continuing on October 2, 2015 will be a safety concern for anyone within a 100-yard radius of the 520 Bridge east span construction operations. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone while the bridge is being repaired.

The safety zone established in this rule encompasses all waters within 100 yards of the east span of the 520 Bridge, located on Lake Washington and is effective from October 2, 2015 through November 30, 2015 when a construction barge is present in the safety zone. Vessels wishing to enter the safety zone must request permission to do so from the Captain of the Port by contacting the Joint Harbor Operations Center at 206-217-6001 or VHF Channel 16. If permission for entry is granted, vessels must proceed at a minimum speed for safe navigation.

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

E.O.s 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. E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under E.O. 12866. Accordingly, it has not been reviewed by the Office of Management and Budget.

This rule is not a significant regulatory action as the safety zone established by it is both limited in size and duration and there is an alternative route for vessels with an air draft that permits safe passage under the west span of the bridge.

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, because the zone established in this rule is limited in size and duration and there is an alternative route for vessels with an air draft that permits safe passage under the west span of the bridge.

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 E.O. 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 E.O. 13132.

Also, this rule does not have tribal implications under E.O. 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 temporary safety zone lasting less than 60 days that will prohibit entry within 100 yards of the east span of the 520 bridge during times of construction operations. It is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated under ADDRESSES. We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.

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:

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, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2014-0374 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 December 21, 2015. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2014-0374, 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 September 5, 2014 (79 FR 53009) (FRL-9914-98), 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 3E8217) by Interregional Research Project Number 4, 500 College Road East, Suite 201W, Princeton, NJ 08540, on behalf of BetaTec Hop Products, Inc. (the petitioner). The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of potassium salts of hop beta acids (K-HBAs) in or on honey and honeycomb resulting from the control of Varroa mites. That document referenced a summary of the petition prepared by the petitioner, which is available in the docket, http://www.regulations.gov. There were 63 comments received in response to the batched notice of filing but none were relevant to the establishment of a tolerance for potassium salts of hops beta acids.

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 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, EPA is required to take into account the factors set forth in FFDCA section 408(b)(2)(D).

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

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

K-HBAs are derived from the resin components of the cones of female hop plants Humulus lupulus. The three major components of K-HBAs are Lupulone (30-55% with an isopropyl side chain), Colupulone (20-55% with an isobutyl side chain), and Adlupulone (5-10% with a secbutyl side chain); the components differ only in the R-side chain attached. K-HBA is classified as a biochemical pesticide because it is naturally occurring (found in Humulus lupulus plant), has a non-toxic mode of action against the target pest, and has a history of exposure to humans and the environment demonstrating minimal toxicity. There is a long history of safe use of HBAs via the oral and dietary exposure to humans from its use as a preservative on meats (estimated range 4.4 milligrams/kilograms (mg/kg) of cooked meat—5.5 mg/kg of frankfurter) and its presence in the beer brewing process. Due to its long history of exposure, K-HBAs are considered to be generally recognized as safe (GRAS) by FDA.

All applicable mammalian toxicology data requirements supporting the petition to establish an exemption from the requirement of a tolerance for the use of potassium salts of hops beta acids as an active ingredient for use to control Varroa mites in or on honey and honeycomb have been fulfilled. No significant toxicological effects were observed in the acute toxicity study or other information from the literature that was used to address the toxicity data requirements. For the Tier I subchronic toxicity studies, data and information from scientific literature were used in support of acceptable rationales to address the data requirements, focusing on the long history of exposure to K-HBAs in food preservation and in the production of beer, which is commonly consumed in the United States. K-HBAs are not structurally-related to known mutagens, nor are they in a chemical class known to contain a known mutagen. Further, from the available toxicity information, there were no systemic effects of potassium salts of hops beta acids via the oral, dermal, or inhalation routes of exposure. For a summary of the data upon which EPA relied, and its human health risk assessment based on that data, please refer to the document entitled, “Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for Potassium Salts of Hops Beta acids” (July 15, 2015), available in the docket for this action.

In examining aggregate exposure, FFDCA section 408 directs EPA to consider available information concerning exposures from the pesticide residue in food and all other non-occupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses).

Human dietary exposure through food to residues of K-HBAs already occurs via its use as a preservative in meats and its natural presence in beer brewing production. EPA does not expect much residue of potassium salts of hops beta acids in honey from its use as a pesticide in hives based on residue studies. In three different studies conducted over 3 years, only one honey sample from one honey super was shown to have residues of hops beta acids (0.44 part per million (ppm)), and the residue level was only slightly above the analytical limits of detection (0.41 ppm) and well below the Limit of Quantitation (1.2 ppm).

No significant exposure via drinking water is expected from its use as an active ingredient as a pesticide. K-HBAs are non-volatile and are expected to degrade rapidly, with 100% degradation in 36 hours in the light and 4 days in the dark. Furthermore, as an insecticide, K-HBAs are formulated into a viscous liquid and coated on fiber strips which are placed inside the beehive such that the product is not sprayed or applied in any way that it would be expected to contact any source of drinking water.

Should exposure occur, however, minimal to no risk is expected for the general population, including infants and children, due to the long history of dietary exposure to K-HBAs.

Non-occupational exposure to potasium salts of hops beta acids is not expected because potassium salts of hops beta acids is formulated into a viscous liquid and coated on fiber strips which are placed inside the beehive. There are no residential proposed uses. However, minimal to no risk is expected for the general population, including infants and children, due to the minimal toxicity of this chemical as demonstrated in the data submitted and evaluated by the Agency, as fully explained in the document entitled, “Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for Potassium Salts of Hops Beta acids” (July 15, 2015), available in the docket for this action.

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 potassium salts of hops beta acids to share a common mechanism of toxicity with any other substances, and potassium salts of hops beta acids does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that potassium salts of hops beta acids 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.

FFDCA section 408(b)(2)(C) provides that, in considering the establishment of a tolerance or tolerance exemption for a pesticide chemical residue, EPA shall assess the available information about consumption patterns among infants and children, special susceptibility of infants and children to pesticide chemical residues, and the cumulative effects on infants and children of the residues and other substances with a common mechanism of toxicity. In addition, FFDCA section 408(b)(2)(C) 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 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 (FQPA) Safety Factor. In applying this provision, EPA either retains the default value of 10X, or uses a different additional or no safety factor when reliable data are available to support a different additional or no safety factor.

As part of its qualitative assessment, EPA evaluated the available toxicity and exposure data on potassium salts of hops beta acids and considered its validity, completeness, and reliability, as well as the relationship of this information to human risk. EPA considers the toxicity database to be complete and has identified no residual uncertainty with regard to prenatal and postnatal toxicity or exposure. No hazard was identified based on the available studies; therefore, EPA concludes that there are no threshold effects of concern to infants, children, or adults from potassium salts of hops beta acids. As a result, EPA concludes that no additional margin of exposure (safety) is necessary.

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

Based on its assessment of potassium salts of hops beta acids, 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 potassium salts of hops beta acids. EPA is therefore establishing an exemption from the requirement of a tolerance for residues of potassium salts of hops beta acids for the control of Varroa mites in or on honey and honeycomb, in accordance with label directions and good agricultural practices.

This final rule establishes an exemption from the requirement of a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule 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 final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

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

This final rule 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 final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (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 of 1995 (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, 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-2015-0442 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 December 21, 2015. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2015-0442, 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 August 26, 2015 (80 FR 51759) (FRL-9931-74), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the receipt of a pesticide petition (PP) IN-10826 filed by BYK USA Inc., 524 South Cherry Street, Wallingford, CT 06492-4453. The petition requested that 40 CFR 180.960 be amended by establishing an exemption from the requirement of a tolerance for residues of poly[oxy(methyl-1,2-ethanediyl)], α-[(9Z)-1-oxo-9-octadecen-1-yl]-ω-[[(9Z)-1-oxo-9-octadecen-1yl]oxy]- (CAS Reg. No. 26571-49-3). That document included a summary of the petition prepared by the petitioner and solicited comments on the petitioner's request. 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 use 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 an exemption from the requirement of 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 . . .” and specifies factors EPA is to consider in establishing an exemption.

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

Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. In the case of certain chemical substances that are defined as polymers, the Agency has established a set of criteria to identify categories of polymers expected to present minimal or no risk. The definition of a polymer is given in 40 CFR 723.250(b) and the exclusion criteria for identifying these low-risk polymers are described in 40 CFR 723.250(d). Poly[oxy(methyl-1,2-ethanediyl)], α-[(9Z)-1-oxo-9-octadecen-1-yl]-ω-[[(9Z)-1-oxo-9-octadecen-1yl]oxy]- conforms to the definition of a polymer given in 40 CFR 723.250(b) and meets the following criteria that are used to identify low-risk polymers.

1. The polymer is not a cationic polymer nor is it reasonably anticipated to become a cationic polymer in a natural aquatic environment.

2. The polymer does contain as an integral part of its composition the atomic elements carbon, hydrogen, and oxygen.

3. The polymer does not contain as an integral part of its composition, except as impurities, any element other than those listed in 40 CFR 723.250(d)(2)(ii).

4. The polymer is neither designed nor can it be reasonably anticipated to substantially degrade, decompose, or depolymerize.

5. The polymer is manufactured or imported from monomers and/or reactants that are already included on the TSCA Chemical Substance Inventory or manufactured under an applicable TSCA section 5 exemption.

6. The polymer is not a water absorbing polymer with a number average molecular weight (MW) greater than or equal to 10,000 daltons.

Additionally, the polymer also meets as required the following exemption criteria specified in 40 CFR 723.250(e).

7. The polymer's minimum number average MW of 2,300 is greater than 1,000 and less than 10,000 daltons. The polymer contains less than 10% oligomeric material below MW 500 and less than 25% oligomeric material below MW 1,000, and the polymer does not contain any reactive functional groups.

Thus, poly[oxy(methyl-1,2-ethanediyl)], α-[(9Z)-1-oxo-9-octadecen-1-yl]-ω-[[(9Z)-1-oxo-9-octadecen-1yl]oxy]- meets the criteria for a polymer to be considered low risk under 40 CFR 723.250. Based on its conformance to the criteria in this unit, no mammalian toxicity is anticipated from dietary, inhalation, or dermal exposure to poly[oxy(methyl-1,2-ethanediyl)], α-[(9Z)-1-oxo-9-octadecen-1-yl]-ω-[[(9Z)-1-oxo-9-octadecen-1yl]oxy]-.

For the purposes of assessing potential exposure under this exemption, EPA considered that poly[oxy(methyl-1,2-ethanediyl)], α-[(9Z)-1-oxo-9-octadecen-1-yl]-ω-[[(9Z)-1-oxo-9-octadecen-1yl]oxy]- could be present in all raw and processed agricultural commodities and drinking water, and that non-occupational non-dietary exposure was possible. The minimum number average MW of poly[oxy(methyl-1,2-ethanediyl)], α-[(9Z)-1-oxo-9-octadecen-1-yl]-ω-[[(9Z)-1-oxo-9-octadecen-1yl]oxy]- is 2,300 daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since poly[oxy(methyl-1,2-ethanediyl)], α-[(9Z)-1-oxo-9-octadecen-1-yl]-ω-[[(9Z)-1-oxo-9-octadecen-1yl]oxy]- conform to the criteria that identify a low-risk polymer, there are no concerns for risks associated with any potential exposure scenarios that are reasonably foreseeable. The Agency has determined that a tolerance is not necessary to protect the public health.

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 poly[oxy(methyl-1,2-ethanediyl)], α-[(9Z)-1-oxo-9-octadecen-1-yl]-ω-[[(9Z)-1-oxo-9-octadecen-1yl]oxy]- to share a common mechanism of toxicity with any other substances, and poly[oxy(methyl-1,2-ethanediyl)], α-[(9Z)-1-oxo-9-octadecen-1-yl]-ω-[[(9Z)-1-oxo-9-octadecen-1yl]oxy]- does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that poly[oxy(methyl-1,2-ethanediyl)], α-[(9Z)-1-oxo-9-octadecen-1-yl]-ω-[[(9Z)-1-oxo-9-octadecen-1yl]oxy]- 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.

Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold 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 data base unless EPA concludes that a different margin of safety will be safe for infants and children. Due to the expected low toxicity of poly[oxy(methyl-1,2-ethanediyl)], α-[(9Z)-1-oxo-9-octadecen-1-yl]-ω-[[(9Z)-1-oxo-9-octadecen-1yl]oxy]-, EPA has not used a safety factor analysis to assess the risk. For the same reasons the additional tenfold safety factor is unnecessary.

Based on the conformance to the criteria used to identify a low-risk polymer, EPA concludes that there is a reasonable certainty of no harm to the U.S. population, including infants and children, from aggregate exposure to residues of poly[oxy(methyl-1,2-ethanediyl)], α-[(9Z)-1-oxo-9-octadecen-1-yl]-ω-[[(9Z)-1-oxo-9-octadecen-1yl]oxy]-.

An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation.

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 poly[oxy(methyl-1,2-ethanediyl)], α-[(9Z)-1-oxo-9-octadecen-1-yl]-ω-[[(9Z)-1-oxo-9-octadecen-1yl]oxy]-.

Accordingly, EPA finds that exempting residues of poly[oxy(methyl-1,2-ethanediyl)], α-[(9Z)-1-oxo-9-octadecen-1-yl]-ω-[[(9Z)-1-oxo-9-octadecen-1yl]oxy]- from the requirement of a tolerance will be safe.

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:

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-2015-0012 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 December 21, 2015. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2015-0012, 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 December 17, 2014 (79 FR 75107) (FRL-9918-90), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of (PP 4E8302) by IR-4, 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the fungicide pyrimethanil, (4,6-dimethyl-N-phenyl-2-pyrimidinamine), in or on cucumber at 1.5 parts per million (ppm); fruit, pome, group 11-10 at 14 ppm; fruit, stone, group 12-12 at 10 ppm; grapefruit subgroup 10-10C at 10 ppm; lemon subgroup 10-10B at 11 ppm; orange subgroup 10-10A at 10 ppm; and tomato subgroup 8-10A at 0.5 ppm. Upon approval of the tolerances in this petition, the petition requested that the tolerances for fruit, citrus, group 10 except lemon, postharvest; fruit, pome, group 11 (preharvest and post-harvest); fruit, stone, group 12; lemon (preharvest and postharvest); and tomato be removed as they are superseded. This petition additionally requested that 40 CFR 180.518 be amended by revising the existing tolerance for onion, bulb, subgroup 3-07A from 2.0 ppm to 0.20 ppm. That document referenced a summary of the petition prepared on behalf of IR-4 by Bayer CropScience, the registrant, which is available in the docket EPA-HQ-OPP-2014-0590 at http://www.regulations.gov. There were no comments received in response to this notice of filing.

In the Federal Register of May 20, 2015 (80 FR 28925) (FRL-9927-39), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of PP 4F8291 by Bayer CropScience, 2 T.W. Alexander Drive, P.O. Box 12014, Research Triangle Park, NC 27709. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the fungicide pyrimethanil, in or on in or on caneberry (subgroup 13-07A) at 15.0 ppm and bushberry (subgroup 13-07B) at 8.0 ppm. That document referenced a summary of the petition prepared by Bayer CropScience, the registrant, which is available in the docket, http://www.regulations.gov. A comment was received on the notice of filing. EPA's response to the comment is discussed in Unit IV.C.

Based upon review of the data supporting the petitions, EPA has revised the petitioned-for tolerance in or on fruit, pome, group 11-10. The Agency has also determined that the separate subgroup tolerances proposed in or on orange subgroup 10-10A, lemon subgroup 10-10B, and grapefruit subgroup 10-10C should be established in or on fruit, citrus, group 10-10. The reasons for these changes are explained in Unit IV.D.

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 pyrimethanil including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with pyrimethanil 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 major target organs of repeated oral exposure to pyrimethanil were the liver, kidney and thyroid. By the oral route of exposure, the rat was the most sensitive species to pyrimethanil toxicity, followed by the dog and then the mouse. Effects observed including clinical signs (for example, vomiting, diarrhea and salivation in the dog), changes in clinical chemical parameters (liver enzymes), changes in organ weights (mostly relative), and macroscopic and microscopic organ changes. These effects were accompanied by decreased body weight. Clinical signs of neurotoxicity including ataxia and dilated pupils, and decreases in motor activity, hind limb grip strength and body temperature were observed in an acute neurotoxicity study in rats (females only) at the highest dose tested (HDT). However, there was no evidence of neurotoxicity with repeated dosing in a subchronic neurotoxicity study in rats.

Special short-term exposure studies conducted for pyrimethanil demonstrated increased liver uridine diphosphate glucuronosyl transferase activity, leading to decreases in thyroid hormones (T3, T4) and compensatory increases in thyroid-stimulating hormone (TSH) in adult rats. Although the effects on the thyroid raise a potential concern for thyroid toxicity in the young, EPA concluded there is no concern for thyroid toxicity in the young based on the following: (1) The effects are not severe in nature and; (2) the wide dose spread (i.e., more than 10-fold difference between the no observed adverse effect levels (NOAELs) and the lowest-observed-adverse-effect-levels (LOAELs) in each of the studies showing effects on thyroid hormone levels (as well as the studies the Agency is using for its points of departure) provides a measure of protection for any potential effects linked to decreased thyroid hormone levels in offspring. Moreover, reproductive toxicity was not observed following pyrimethanil administration, and developmental effects (e.g., decreased fetal weight, retarded ossification, extra ribs) were observed only at doses that caused maternally toxic effects (e.g., death, decreased body weight and body-weight gain); therefore, pyrimethanil is not expected to result in increased quantitative or qualitative susceptibility for infants and children.

Thyroid adenomas were seen in rats following long-term exposure, and it was concluded that they were mediated via disruption of the thyroid/pituitary axis. There were no concerns for mutagenicity. The EPA has classified pyrimethanil as “not likely to be carcinogenic to humans at doses that do not alter rat thyroid hormone homeostasis.” This decision was based on the following:

1. There were treatment-related increases in thyroid follicular cell tumors in male and female Sprague-Dawley rats at doses which were considered adequate to assess carcinogenicity; however, rats are substantially more sensitive than humans to the development of thyroid follicular cell tumors in response to thyroid hormone imbalance.

2. There were no treatment-related tumors seen in male or female CD-1 mice at doses which were considered adequate to assess carcinogenicity.

3. There is no mutagenicity concern and there is no evidence for thyroid carcinogenesis mediated through a mutagenic mode of action.

4. The non-neoplastic toxicological evidence (i.e., thyroid growth, thyroid hormonal changes) indicated that pyrimethanil was inducing a disruption in the thyroid-pituitary hormonal status. The overall weight-of-evidence was considered sufficient to indicate that pyrimethanil induced thyroid follicular tumors through a non-linear, antithyroid mode of action.

For these reasons, EPA determined that quantification of carcinogenic risk is not required and that the NOAEL established for deriving the chronic reference dose (cRfD) would be protective of cancer effects. Due to the non-linear mode of action of pyrimethanil, exposure at the NOAEL is not expected to alter thyroid hormone homeostasis nor result in thyroid tumor formation.

Specific information on the studies received and the nature of the adverse effects caused by pyrimethanil as well as the NOAEL and the LOAEL from the toxicity studies can be found at http://www.regulations.gov in document, “Pyrimethanil. Human Health Risk Assessment for Proposed Uses on Greenhouse-Grown Cucumbers, Tomato Subgroup 8-10A, Lemon Subgroup 10-10B, Orange Subgroup 10-10A, Grapefruit Subgroup 10-10C, Pome Fruit Group 11-10, Stone Fruit Group 12-12 Caneberry Subgroup 13-07A, and Bushberry Subgroup 13-07B,” in pp. 29-31 in docket ID number EPA-HQ-OPP-2015-0012.

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 the NOAEL and the LOAEL are identified. Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a 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 pyrimethanil used for human risk assessment is discussed in Table 1 in Unit III.B. of the final rule published in the Federal Register of August 1, 2012 (77 FR 45499) (FRL-9354-7).

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to pyrimethanil, EPA considered exposure under the petitioned-for tolerances as well as all existing pyrimethanil tolerances in 40 CFR 180.518. EPA assessed dietary exposures from pyrimethanil 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 pyrimethanil. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 2003-2008 National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in food, EPA assumed default processing factors, empirical processing factors for orange and apple juice, tolerance-level residues, and 100 percent crop treated (PCT) for all commodities.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 2003-2008 NHANES/WWEIA. As to residue levels in food, EPA assumed default processing factors, empirical processing factors for orange and apple juice, tolerance-level residues, and 100 PCT for all commodities.

iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that pyrimethanil is not likely to be carcinogenic to humans at doses that do not alter rat thyroid hormone homeostasis. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk was not performed.

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

2. Dietary exposure from drinking water. In drinking water, residues of concern are pyrimethanil and the degradate 2-amino-4,6-dimethylpyrimidine. The Agency used screening-level water exposure models in the dietary exposure analysis and risk assessment for pyrimethanil and its degradate in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of pyrimethanil and its degradate. 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 Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Surface Water Concentration Calculator (SWCC) models, the estimated drinking water concentrations (EDWCs) of pyrimethanil and its degradate for acute exposures are estimated to be 156 parts per billion (ppb) for surface water and 128 ppb for ground water. For chronic exposures for non-cancer assessments, they are estimated to be 27.9 ppb for surface water and 117 ppb for ground water.

Current EPA policy typically recommends the EDWCs for use in dietary assessments be derived from the water source with the highest EDWCs, which for pyrimethanil is surface water for acute exposure and groundwater for chronic exposure. However, due to generally low leaching (EDWCs and incomplete breakthrough) identified in the 100-year simulation in groundwater, the surface water EDWCs are recommended for both acute and chronic exposure assessments. Therefore, for acute dietary risk assessment, the water concentration value of 156 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 27.9 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). Pyrimethanil 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.” EPA has not found pyrimethanil to share a common mechanism of toxicity with any other substances, and pyrimethanil does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that pyrimethanil does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

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

2. Prenatal and postnatal sensitivity. The prenatal and postnatal toxicology database for pyrimethanil includes rat and rabbit developmental toxicity studies and a 2-generation reproduction toxicity study in rats. As discussed in Unit III.A., there was no evidence of increased quantitative or qualitative susceptibility of fetuses or offspring following exposure to pyrimethanil in these studies.

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 1X. That decision is based on the following findings:

i. The toxicity database for pyrimethanil is complete.

ii. Clinical signs of neurotoxicity (ataxia, decreased motor activity, decreased body temperature, decreased hind limb grip strength in males, and dilated pupils) were observed only in females in the acute neurotoxicity study in rats and only at the HDT (1,000 milligram/kilogram (mg/kg)). Although the limit dose was not tested in the subchronic neurotoxicity study, no clinical signs, behavioral changes, or neuropathology were seen at one-half of the limit dose (up to 430 milligram/kilogram/day (mg/kg/day)). In addition, no neurotoxic signs were seen in the rest of the toxicity database for pyrimethanil and the target organ for toxicity is the thyroid. The selected endpoints for pyrimethanil will be protective of any potential signs of neurotoxicity. Therefore, the concern for neurotoxicity is low, and there is no need for a developmental neurotoxicity study or additional uncertainty factors (UFs) to account for neurotoxicity.

iii. There is no evidence that pyrimethanil 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 dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the surface water modeling used to assess exposure to pyrimethanil in drinking water. These assessments will not underestimate the exposure and risks posed by pyrimethanil.

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 pyrimethanil will occupy 40% of the aPAD for children one to two 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 pyrimethanil from food and water will utilize 80% of the cPAD for children one to two years old, the population group receiving the greatest exposure. There are no residential uses for pyrimethanil.

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

4. Aggregate cancer risk for U.S. population. EPA has determined that the thyroid tumors seen in rat studies arise through a non-linear mode of action and the NOAEL (17 mg/kg/day) established for deriving the cRfD is not expected to alter thyroid hormone homeostasis nor result in thyroid tumor formation. Thus, the chronic risk assessment addresses any cancer risk. Based on the results of chronic risk assessment, EPA concludes that aggregate exposure to pyrimethanil will not cause a cancer risk.

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

Adequate enforcement methodology, high-performance liquid chromatography (HPLC), is available to enforce the tolerance expression.

The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: [email protected].

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.

There are no Codex MRLs established for residues of pyrimethanil in or on cucumber or bushberry subgroup 13-07B or caneberry subgroup 13-07A commodities. A U.S. tolerance in or on pome fruit group 11-10 was petitioned-for at 14 ppm; however, the EPA is establishing a tolerance at 15 ppm in order to harmonize with Codex MRLs established on associated pome fruit commodities at 15 ppm. The U.S. tolerance in or on bulb onion subgroup 3-07A at 0.20 ppm is harmonized with a Codex MRL on bulb onion. Although there is a Codex MRL at 0.7 ppm for tomato, EPA is establishing a tolerance for the tomato subgroup 8-10A at 0.50 ppm in order to harmonize with the Canadian MRL to facilitate trade with Canada. The U.S. tolerances for citrus fruit group 10-10 at 10 ppm and stone fruit group 12-12 at 10 ppm cannot be harmonized with Codex MRLs on the same commodities because the residue data supporting these uses result in tolerance calculations that are higher than the Codex MRLs for citrus (7 ppm) and the range of MRLs for stone fruit commodities (2 ppm to 4 ppm), which precludes harmonization.

One comment was received to the Notice of Filing for PP 4F8291, which provided general support for the proposed tolerances. There were no concerns identified in this public comment.

Based upon review of the data supporting the petitions, EPA has revised the petitioned-for tolerance in or on fruit, pome, group 11-10 from 14 ppm to 15 ppm, in order to harmonize with the Codex MRL on associated pome fruit commodities. The Agency has also determined that the separate subgroup tolerances petitioned-for in or on orange subgroup 10-10A at 10 ppm, lemon subgroup 10-10B at 11 ppm, and grapefruit subgroup 10-10C at 10 ppm should be established in or on fruit, citrus, group 10-10 at 10 ppm. A citrus group 10-10 tolerance at 10 ppm is supported by available data and harmonizes the U.S. tolerance with the Canadian MRL.

In this rulemaking, EPA is reducing the tolerance for the onion, bulb, subgroup 3-07A from 2.0 ppm to 0.20 ppm. The petitioner requested this reduction because it was a typographical error when the previous rule for pyrimethanil was published. EPA had assessed the tolerance at 0.20 ppm, but the rule was printed as 2.0 ppm. The reduction is appropriate based on available data and residue levels resulting from registered use patterns. In accordance with the World Trade Organization's Sanitary and Phytosanitary Measures Agreement, EPA is allowing the existing higher tolerance to remain in effect for 6 months following the publication of this rule in order to allow a reasonable interval for producers in the exporting countries to adapt to the requirements of these modified tolerances. On April 21, 2016, the new reduced tolerance for subgroup 3-07A will go into effect. At that time, residues of pyrimethanil on commodities contained in subgroup 3-07A will need to comply with the new tolerance of 0.20 ppm. This reduction in tolerance is not discriminatory; the same food safety standard contained in the FFDCA applies equally to domestically produced and imported foods.

Therefore, tolerances are established for residues of pyrimethanil (4,6-dimethyl-N-phenyl-2-pyrimidinamine) in or on bushberry subgroup 13-07B at 8.0 ppm; caneberry subgroup 13-07A at 15 ppm; cucumber at 1.5 ppm; fruit, citrus, group 10-10 at 10 ppm; fruit, pome, group 11-10 at 15 ppm; fruit, stone group 12-12 at 10 ppm; and tomato subgroup 8-10A at 0.50 ppm. This regulation additionally revises the tolerance in or on onion, bulb, subgroup 3-07A from 2.0 ppm to 0.20 ppm. Finally, this regulation removes tolerances in or on fruit, citrus, group 10, except lemon, postharvest; fruit, pome, group 11 (pre-harvest and post-harvest); fruit, stone, group 12; lemon, preharvest and postharvest; and tomato.

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 tolerances 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:

States which have received final authorization from the EPA under RCRA section 3006(b), 42 U.S.C. 6926(b), must maintain a hazardous waste program that is equivalent to, consistent with, and no less stringent than the Federal program. As the Federal program changes, States must change their programs and ask the EPA to authorize the changes. Changes to State programs may be necessary when Federal or State statutory or regulatory authority is modified or when certain other changes occur. Most commonly, States must change their programs because of changes to the EPA's regulations in 40 Code of Federal Regulations (CFR) parts 124, 260 through 268, 270, 273, and 279.

New Federal requirements and prohibitions imposed by Federal regulations that EPA promulgates pursuant to the Hazardous and Solid Waste Amendments of 1984 (HSWA) take effect in authorized States at the same time that they take effect in unauthorized States. Thus, EPA will implement those requirements and prohibitions in the State of Texas, including the issuance of new permits implementing those requirements, until the State is granted authorization to do so.

On April 3, 2015, the State of Texas submitted a final complete program revision application seeking authorization of changes to its hazardous waste program that correspond to certain Federal rules promulgated between promulgated between June 13, 2011, and January 3, 2014. The adoption for RCRA Clusters XXI through XXIII (Checklists 227, 229 and 230). EPA concludes that the State of Texas's application to revise its authorized program meets all of the statutory and regulatory requirements established by RCRA, as set forth in RCRA section 3006(b), 42 U.S.C. 6926(b), and 40 CFR part 271. Therefore, EPA grants the State of Texas final authorization to operate its hazardous waste program with the changes described in the authorization application, and as outline below in Section G of this document. The State of Texas has responsibility for permitting treatment, storage, and disposal facilities (TSDFs) within its borders (except in Indian Country). In today's action under Section 18 U.S.C. 1151 does not affect Indian Country. Because the State of Texas Hazardous waste Program is not being authorized to operate in Indian Country and for carrying out the aspects of the RCRA program described in its revised program application, subject to the limitations of HSWA, as discussed above). New Federal requirements and prohibitions imposed by Federal regulations that EPA promulgates under the authority of HSWA take effect in authorized States before they are authorized for the requirements. Thus, EPA will implement those requirements and prohibitions in the State of Texas, including issuing permits, until the State is granted authorization to do so.

The effect of this decision is that a facility in the State of Texas subject to RCRA will now have to comply with the authorized State requirements instead of the equivalent Federal requirements in order to comply with RCRA. The State of Texas has enforcement responsibilities under its State hazardous waste program for violations of such program, but the EPA retains its authority under RCRA sections 3007, 3008, 3013, and 7003, which include, among others, authority to:

• Do inspections, and require monitoring, tests, analyses, or reports;

• enforce RCRA requirements and suspend or revoke permits and

• take enforcement actions after notice to and consultation with the State.

This action does not impose additional requirements on the regulated community because the regulations for which the State of Texas is being authorized by today's action are already effective under State law, and are not changed by today's action.

Along with this direct final rule, EPA is publishing a separate document in the “Proposed Rules” section of today's Federal Register that serves as the proposal to authorize these State program changes. EPA did not publish a proposal before today's rule because EPA views this as a routine program changes and does not expect comments. EPA also views the State of Texas program revisions as noncontroversial action and anticipate no adverse comment.

EPA is providing an opportunity for public comment now, as described in Section E of this document.

If the EPA receives comments that oppose this authorization, EPA will withdraw today's direct final rule by publishing a document in the Federal Register before the rule becomes effective. The EPA will base any further decision on the authorization of the State program changes on the proposal mentioned in the previous section, after considering all comments received during the comment period. EPA will then address all public comments in a later final rule. You may not have another opportunity to comment. If you want to comment on this authorization, you must do so at this time.

If EPA receives comments that oppose only the authorization of a particular change to the State hazardous waste program, EPA will withdraw only that part of this rule, but the authorization of the program changes that the comments do not oppose will become effective on the date specified in this document. The Federal Register withdrawal document will specify which part of the authorization will become effective, and which part is being withdrawn.

The State of Texas initially received final authorization on December 26, 1984 (49 FR 48300), to implement its Base Hazardous Waste Management Program. This authorization was clarified in a notice published March 26, 1985 (50 FR 11858). Texas received authorization for revisions to its program, effective October 4, 1985 (51 FR 3952), February 17, 1987 (51 FR 45320), March 15, 1990 (55 FR 7318), July 23, 1990 (55 FR 21383), October 21, 1991 (56 FR 41626), December 4, 1992 (57 FR 45719), June 27, 1994 (59 FR 16987), June 27, 1994 (59 FR 17273), November 26, 1997 (62 FR 47947), December 3, 1997 (62 FR 49163), October 18, 1999 (64 FR 44836), November 15, 1999 (64 FR 49673), September 11, 2000 (65 FR 43246), June 14, 2005 (70 FR 34371), December 29, 2008, (73 FR 64252), and July 13, 2009 (74 FR 22469). The EPA incorporated by reference Texas' then authorized hazardous waste program effective December 3, 1997 (62 FR 49163), November 15, 1999 (64 FR 49673), December 29, 2008 (73 FR 64252), March 7, 2011 (76 FR 12285) effective May 6, 2011 and March 6, 2012 (77 FR 13200) effective May 7, 2012 and September 3, 2014 (79 FR 52220-52224) effective November 3, 2014.

In 1991, Texas Senate Bill 2 created the Texas Natural Resource Conservation Commission (TNRCC) which combined the functions of the former Texas Water Commission and the former Texas Air Control Board. The transfer of functions to the TNRCC from the two agencies became effective on September 1, 1993. House Bill 2912, Article 18 of the 77th Texas Legislature, 2001, changed the name of the TNRCC to the Texas Commission on Environmental Quality (TCEQ) and directed the TNRCC to adopt a timetable for phasing in the change of the agency's name. The TNRCC decided to make the change of the agency's name to the TCEQ effective September 1, 2002. The change of name became effective September 1, 2002, and the legislative history of the name change is documented at (See, Act of June 15, 2001, 77th Leg. R. S., Ch 965, Section 18.01, 2001 Tex. Gen. Laws 1985). The TCEQ may perform any act authorized by law either as the TNRCC or as the TCEQ. Id. Therefore, references to the TCEQ are references to TNRCC and to its successor, the TCEQ.

The TCEQ has primary responsibility for administration of laws and regulations concerning hazardous waste. The official State regulations may be found in Title 30, Texas Administrative Code, Chapters 305, 324 and 335, effective February 21, 2013. Some of the State rules incorporate the Federal regulations by reference. Texas Water Code Section 5.103 and Section 5.105 and Texas Health and Safety Code Section 361.017 and Section 361.024 confer on the Texas Commission on Environmental Quality the powers to perform any acts necessary and convenient to the exercise of its jurisdiction. The TCEQ is authorized to administer the RCRA program. However, the Railroad Commission (RRC) has jurisdiction over the discharge, storage, handling, transportation, reclamation, or disposal of waste materials (both hazardous and non-hazardous) that result from the activities associated with the exploration, development, or production of oil or gas or geothermal resources and other activities regulated by the RRC. A list of activities that generate wastes that are subject to the jurisdiction of the RRC is found at Texas Health and Safety Code Section 401.415. Such wastes are termed “oil and gas wastes.” The TCEQ has responsibility to administer the RCRA program, however, hazardous waste generated at natural gas or natural gas liquids processing plants or reservoir pressure maintenance or repressurizing plants are subject to the jurisdiction of the TCEQ until the RRC is authorized by EPA to administer that waste under RCRA. The TCEQ jurisdiction over Solid waste can be found at Chapter 361, Sections 361.001 through 361.754 of the Texas Health and Safety Code. The TCEQ's jurisdiction encompasses hazardous and nonhazardous, industrial and municipal Solid waste. The definition of Solid waste can be found at Texas Health and Safety Code Section 361.003(34). When the RRC is authorized by EPA to administer the RCRA program for these wastes, jurisdiction over such hazardous waste will transfer from the TCEQ to the RRC. The EPA has designated the TCEQ as the lead agency to coordinate RCRA activities between the two agencies. The EPA is responsible for the regulation of any hazardous waste for which TCEQ has not been previously authorized.

Further clarification of the jurisdiction between the TCEQ and the RRC can be found in a separate document. This document, a Memorandum of Understanding (MOU), became effective on May 31, 1998.

The TCEQ has the rules necessary to implement EPA's RCRA Clusters XXI through XXIII, excluding the Hazardous Waste Technical Corrections and Clarification Rule in Cluster XXII (Checklist 228), because the TCEQ needs to make a technical corrections to their adoption of the rule. The State is seeking authorization for Revision of the Land Disposal Treatment Standards for Carbamate Wastes (Checklist 227), Conditional Exclusion for Solvent Contaminated Wipes (Checklist 229) and Conditional Exclusion for Carbon Dioxide (CO2) Streams in Geologic Sequestration Activities (Checklist 230). The Commissioners adopted revisions to the Federal hazardous waste standards promulgated between June 13, 2011, and January 3, 2014. TCEQ regulations 30 Texas Administrative Code Chapter 335 were revised to include these revisions to the RCRA Clusters XXI through XXIII. The TCEQ adopted the Federal regulations on December 10, 2014. The revisions were published in the Texas Register on January 2, 2015 and became effective on January 8, 2015. The TCEQ authority to incorporate Federal rules by reference can be found at Texas Administrative Code 335 Sections 335.28, 335.29 and 335.31.

On April 3, 2015 the State of Texas submitted a final complete program revision application, seeking authorization of their changes in accordance with 40 CFR 271.21. We now make direct final decision, subject to receipt of written comments that oppose this action that the State of Texas' hazardous waste program revision are equivalent to, consistent with, and no less stringent than the Federal program, and therefore satisfy all of requirements necessary to qualify for final authorization. Therefore, EPA grants the State of Texas final authorization for RCRA Cluster XXII through XXIII (Checklists 227, 229 and 230). The State of Texas program revisions consist of regulations which specifically govern Federal Hazardous Waste revisions promulgated between June 13, 2011, and January 3, 2014 which are listed in the chart below.

The State of Texas hazardous waste program is equivalent to the Federal program in all areas except where the State program is broader in scope. In the State of Texas, some rules are broader in scope because they cover both hazardous waste and Class 1 nonhazardous waste, whereas the Federal regulations cover only hazardous waste. Other differences which are broader in scope or more stringent contained in the past authorization packages include more frequent public notices for traditional hazardous waste permits and for Standard Permit; financial assurance requirements for persons seeking to acquire a hazardous waste permit through transfer, and deferring of variances and exemptions from the Land Disposal Restrictions to EPA.

The State of Texas will issue permits for all the provisions for which it is authorized and will administer the permits it issues. The EPA will continue to administer any RCRA hazardous waste permits or portions of permits which we issued prior to the effective date of this authorization. EPA will not issue any more new permits or new portions of permits for the provisions listed in the chart in this document after the effective date of this authorization. The EPA will continue to implement and issue permits for HSWA requirements for which Texas is not yet authorized.

Codification is the process of placing the State's statutes and regulations that comprise the State's authorized hazardous waste program into the CFR. We do this by referencing the authorized State rules in 40 CFR parts 272. We reserve the amendment of 40 CFR parts 272, subpart SS for this authorization of Texas' program changes until a later date. In this authorization application the EPA is not codifying the rules documented in this Federal Register document.

The Office of Management and Budget (OMB) has exempted this action from the requirements of Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011). Therefore this action is not subject to review by OMB. This action authorizes State requirements for the purpose of RCRA 3006 and imposes no additional requirements beyond those imposed by State law. Accordingly, I certify that this action will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). Because this action authorizes preexisting requirements under State law and does not impose any additional enforceable duty beyond that required by State law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). For the same reason, this action also does not significantly or uniquely affect the communities of Tribal governments, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because it merely authorizes State requirements as part of the State RCRA hazardous waste program without altering the relationship or the distribution of power and responsibilities established by RCRA. This action also is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it is not economically significant and it does not make decisions based on environmental health or safety risks. This rule is not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355 (May 22, 2001)) because it is not a significant regulatory action under Executive Order 12866.

Under RCRA 3006(b), the EPA grants a State's application for authorization as long as the State meets the criteria required by RCRA. It would thus be inconsistent with applicable law for the EPA, when it reviews a State authorization application; to require the use of any particular voluntary consensus standard in place of another standard that otherwise satisfies the requirements of RCRA. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. As required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996), in issuing this rule, the EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct. The EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining the takings implications of the rule in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings” issued under the Executive Order. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). Executive Order 12898 (59 FR 7629, Feb. 16, 1994) establishes federal executive policy on environmental justice. Its main provision directs federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States. Because this rule authorizes pre-existing State rules which are at least equivalent to, and no less stringent than existing federal requirements, and imposes no additional requirements beyond those imposed by State law, and there are no anticipated significant adverse human health or environmental effects, the rule is not subject to Executive Order 12898.

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 document 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 in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2). This action nevertheless will be effective December 21, 2015.

This final rule is being issued to delay the effective and compliance dates of the Unified Registration System (URS) final rule, issued on August 23, 2013.1 Because FMCSA changes the effective date (the actual date when the regulatory text that appears in the Code of Federal Regulations (CFR) will be changed) and makes technical corrections and conforming amendments to the 2013 regulatory text, the Agency has determined that it is in the best interest of the regulated entities, our State partners and the general public to present the full text of the sections affected. The URS final rule was issued to improve the registration process for motor carriers, property brokers, freight forwarders, IEPs, HMSP applicants and cargo tank facilities required to register with FMCSA, and streamline the existing Federal registration processes to ensure the Agency can more efficiently track these entities. The URS final rule increases public accessibility to data about interstate motor carriers, property brokers, freight forwarders, IEPs, HMSP applicants, and cargo tank facilities. Full implementation of the URS final rule will replace the registration functions of the following systems: (1) The U.S. Department of Transportation (USDOT) identification number system; (2) the 49 U.S.C. chapter 139 commercial registration system; (3) the 49 U.S.C. 13906 financial responsibility information system; and (4) the service of process agent designation system (49 U.S.C. 503 and 13304).

FMCSA estimated a 2-year period for development of the information technology (IT) system to implement the August 23, 2013, URS final rule, and as a result set the initial compliance date for the majority of that rule at 26 months after publication (October 23, 2015).2 During the 2 years since publication of the final rule, the Agency has experienced challenges completing the IT system necessary to fully implement the 2013 final rule. FMCSA also received a protest during the acquisition process for a supporting contractor, which added to delays in development of the IT system for integrating and retiring the FMCSA legacy registration systems. The Agency and its supporting contractors worked diligently in the past 24 months to meet the original URS final rule's effective date, but ultimately determined that full implementation of the URS cannot be accomplished by that time.

As a result, FMCSA is delaying the effective and compliance dates of the URS final rule, as reflected in the table at the end of this executive summary. The new dates reflect the revised schedule for completing the IT system required. In doing so, the Agency determined that a discrete portion of the IT system will be available earlier than others, and so we are adding three temporary sections, one each in parts 365, 368, and 390, to allow for implementation of that portion of the new URS. These temporary sections will apply to new U.S.- or Canada-domiciled applicants and Mexico-domiciled applicants seeking registration to operate in the commercial zones along the U.S.-Mexico border. A new applicant is defined as anyone who does not have, and has never been assigned a USDOT, Motor Carrier (MC), Mexico owned or controlled (MX), or Freight Forwarder (FF) number. These new applicants will be required to use the new online application when requesting registration and a USDOT number beginning on December 12, 2015. The new online application and associated database will not be available for use by those who already have USDOT, MC, MX, or FF numbers until September 30, 2016, so we are establishing the new overall effective date of this final rule to coincide with that availability. Once that occurs, there will no longer be a need for the separate provisions dealing with new applicants, thus the temporary sections will be in effect only from December 12, 2015 through September 29, 2016. After that time, the URS system, including the online application, will be available for submission of all requests for new registration, to track applications, to update information, and to file biennial updates.

While we are delaying the effective date for most of the URS final rule requirements until September 30, 2016, we are providing an additional three months for full compliance with some provisions. Private hazardous material carriers and exempt for-hire carriers registered with the Agency as of September 30, 2016, will be given three months from that date to file their evidence of compliance with the financial responsibility requirements. While these carriers have had to obtain adequate insurance coverage for some time now, the 2013 final rule provided the first rule requiring them to file proof of that coverage with FMCSA. As a result, FMCSA believes allowing for a three month compliance period will help alleviate potential concerns entities may have over using a new system, as well as ensure seamless operation of the URS.

Additionally, all entities registered with the Agency as of September 30, 2016, will have this same three month period to file their designation of a process service agent (Form BOC-3) using the URS online application. This delay is to ensure that regulated entities have sufficient time to become familiar with the system.

The new URS will be capable of handling both financial responsibility and designation of process agent filings on September 30, 2016, and FMCSA encourages those entities required to make these filings as early in the compliance period as they can. In order to include this staggered compliance period, we have revised § 366.2 (designation of process service agent) and sections 387.19 and 387.43 (financial responsibility) slightly from what was published on August 23, 2013, as explained in greater detail in the section-by-section discussion below.

We are making corrections to errors found in the original final rule since its publication. In parts 385, 387, 390 and 392 we are correcting inadvertent errors to the authority citations. In § 387.403, we are making conforming amendments based on other final rules that affected the registration requirements since the publication of the August 23, 2013 URS final rule. In § 390.207, we are correcting a cross reference. In § 368.8, we are removing a statement that “decisions by the Director will be final Agency orders on certain appeals”—the Agency has changed its internal delegations, and this sentence is no longer accurate. Finally, we are updating the web address for obtaining access to URS to provide a more precise location, as opposed to the main FMCSA home page. These changes are not substantive and are explained in more detail in the section-by-section discussion below. Finally, we have incorporated corrections that were made in an October 23, 2013 correction document.3

To view comments submitted to previous rulemaking notices on this subject, as well as documents identified in this preamble as available in the docket, go to http://www.regulations.gov and click on the “Read Comments” box in the upper right hand side of the screen. Then, in the “Keyword” box, insert “FMCSA-1997-2349” and click “Search.” Next, click “Open Docket Folder” in the “Actions” column. Finally, in the “Title” column, click on the document you would like to review. If you do not have access to the Internet, you may view the docket online by visiting the Docket Management Facility in Room W12-140 on the ground floor of the DOT West Building, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m., ET, Monday through Friday, except Federal holidays.

All comments received were posted without change to http://www.regulations.gov. In accordance with 5 U.S.C. 553(c), DOT previously solicited comments from the public to better inform its rulemaking process. DOT posted these comments, without edit, including any personal information the commenter provides, to www.regulations.gov, as described in the system of records notice (DOT/ALL-14 FDMS), which can be reviewed at www.dot.gov/privacy.

FMCSA relies upon the same legal authority cited in the August 23, 2013, Unified Registration System (URS) final rule. The Agency extends the effective and compliance dates, and makes technical corrections and conforming amendments to the 2013 final rule. Because there are no substantive changes to content of the 2013 final rule, we will not expand upon the previous legal authority discussion presented in that rule.

The Administrative Procedure Act (APA) (5 U.S.C. 551-706) specifically provides exceptions to its notice and public comment rulemaking requirements where the Agency finds there is good cause (and incorporates the finding and a brief statement of reasons therefore in the rules issued) to dispense with them. Generally, good cause exists where the Agency determines that notice and public procedures are impractical, unnecessary, or contrary to the public interest (5 U.S.C. 553(b)(3)(B)). Today's URS final rule is being issued to delay the effective date of the original August 23, 2013, final rule. FMCSA will not have the technological ability to support the changes made by the August 23, 2013, final rule by its original effective date (October 23, 2013), which would make it impossible for motor carriers to comply with the original effective date. If FMCSA does not delay the effective date, motor carriers would find themselves unable to obtain a USDOT number, request registration, or file evidence of meeting the financial responsibility requirements, among other things. The motor carrier registration process would grind to a halt, posing potential harm to motor carriers, other FMCSA-regulated entities, drivers, and those who use their services. For these reasons, FMCSA finds good cause to dispense with notice and public comment on the effective date delaying portions of this final rule, as providing for public notice and comment would be contrary to the public interest.

For those portions of this final rule which are correcting errors in the original August 23, 2013 final rule, we likewise find good cause to dispense with notice and public comment, as doing so is unnecessary. These correcting changes are not substantive in nature; they are being made to correct inadvertent errors and in one instance, to indicate a change in the internal delegations within the Agency. Delaying the effective date of these changes to procure notice and comment would further postpone these corrections, possibly lead to greater confusion, and thus would be contrary to the public interest.

The Federal Highway Administration (FMCSA's predecessor agency) issued an advance notice of proposed rulemaking (ANPRM) announcing plans to develop a single, online, Federal information system in August 1996.4 The ANPRM solicited specific detailed information from the public about each of the systems to be replaced by the URS, the conceptual design of the URS, uses and users of the information to be collected, and potential costs.

On May 19, 2005, FMCSA published an NPRM describing a proposal to merge all of the prescribed information systems except the SSRS into a unified, online Federal system.5 The Agency subsequently revised the May 2005 proposal in an October 26, 2011, SNPRM to incorporate new congressionally mandated provisions in SAFETEA-LU, and modified certain proposals in response to comments to the NPRM.6 The SNPRM also included changes necessitated by final rules published subsequent to publication of the NPRM that directly impacted the URS. In the SNPRM, the Agency substantially altered the regulatory drafting approach proposed in the NPRM by creating a straightforward requirement for all entities to register and biennially update registration information under the new URS and by compiling a centralized cross-reference to existing safety and commercial regulations necessary for compliance with the registration requirements. The Agency abandoned previous efforts to reorganize all registration and new entrant requirements under a single part under title 49, Code of Federal Regulations (CFR) chapter III. FMCSA issued the final rule for URS on August 23, 2013.7

Upon enactment, MAP-21 affected a number of rules already being developed by FMCSA, including this one. Because MAP-21 was enacted several months after the close of the comment period for the SNPRM, the public did not have an opportunity to comment on provisions of the Act that may have an impact on the URS. Rather than delay issuance of the August 23, 2013, final rule, and to ensure an appropriate opportunity for public participation in the changes necessitated by MAP-21, FMCSA decided to initiate a separate rulemaking proceeding(s) to address most of the needed changes.

The section-by-section analysis from the August 23, 2013, URS final rule continues to apply to today's final rule, as today's actions delay the effective and compliance dates provided in that rule and make technical corrections and conforming amendments to that rule. The following analysis is limited to discussing these delayed dates, technical corrections and conforming amendments, and explaining how they are being reflected in the regulatory text. Because of the multiple CFRs affected by today's final rule, the Agency has determined that it is in the best interest of the regulated entities, our State partners and the general public to present the full regulatory text for the amended URS requirements, as opposed to simply correcting the effective date and errant provisions. This action will make it easier for the reader to follow.

Throughout the regulatory text, we updated the web address for accessing the URS; the new address provides a more precise location (www.fmcsa.dot.gov/urs), as opposed to the old address (www.fmcsa.dot.gov), which directed entities to the FMCSA homepage with directions to search using keywords. We also updated the way we refer to the Form MCSA-1, the URS online application, to reflect the terminology used on the FMCSA Web site.

This final rule delays the effective dates for the amendments to sections 360.1, 360.3, and 360.5. FMCSA has determined that it would not be appropriate to collect new filing fees for each registration authority sought by an applicant until the new URS is able to support the new functionality those fees were designed to fund. Therefore, these provisions will now become effective on September 30, 2016, at the same time that the full functionality of the URS will also be available. Those new applicants using the URS online application before September 30, 2016, will pay the same fees as they would today using the current application forms and procedures. Beginning on September 30, 2016, all applicants will be charged a separate $300 fee for each distinct registration for which they apply with each entity that operates commercial motor vehicles in interstate commerce paying $300 for the safety registration and $300 for each additional registration. For example, a freight forwarder operating commercial motor vehicles in interstate commerce would pay $300 for the safety registration and $300 for registration as a freight forwarder. And a new private motor carrier of property that also seeks registration as a for-hire to enable the entity to transport freight for others on return trips would pay $300 for the safety registration and $300 for registration as a for-hire motor carrier of property. The full list of registration types that carry this $300 fee are:

This final rule will delay the effective dates for the amendments to sections 365.101, 365.103, 365.105, 365.107, 365.109, 365.110, 365.111, 365.119, 365.201, 365.203, 365.301, 365.401, 365.403, 365.405, 365.507, and 365.509.

This final rule also adds temporary § 365.T106, which will be in effect from December 12, 2015, through September 29, 2016. Under this temporary section, new applicants, defined as U.S.- or Canada-domiciled entities that do not have (and have never had) an active USDOT, MC, MX, or FF Number, must apply for a USDOT number and, if applicable, operating authority using the URS online application, available at http://www.fmcsa.dot.gov/urs. These applications will be processed using the same legacy systems available to FMCSA today, and will be transitioned over to the complete URS database with those records that already exist in the legacy systems. Applicants will have the ability to print out a summary of their online application after their application is complete and their fee is paid.

This final rule will delay the effective dates for the revisions to sections 366.1, 366.2, 366.3, 366.4, 366.5, and 366.6. The requirement for electronic filing of Form BOC-3, designation of process agent, comes into effect on September 30, 2016; however, entities already registered with FMCSA as of that date will not be required to comply until December 31, 2016. The URS will have the ability to collect the Form BOC-3 filings on September 30, 2016, and we encourage motor carriers and freight forwarders to comply with this requirement as early as they can. In addition, this final rule will no longer make a distinction between private motor carriers or exempt freight forwarders when it comes to compliance dates. The system will be able to receive all notices at the same time, and all are being provided with additional time than originally included in the August 23, 2013 final rule. Note that after September 30, 2016, new applicants (i.e. entities that have not registered with FMCSA prior to September 30, 2016) will need to ensure a Form BOC-3 is submitted before registration will be granted.

This final rule delays the effective date for the revisions in sections 368.3, 368.4, and 368.8 until September 30, 2016, when FMCSA estimates the URS online application will be available for all users, and the majority of the functionality of the URS will be fully available.

This final rule also adds temporary § 368.T3, which will be in effect from December 12, 2015, through September 29, 2016. Under this temporary section, new applicants, defined as citizens of Mexico or motor carriers owned or controlled by a citizen of Mexico, who do not have (and have never had) an active USDOT, MC, MX, or FF number, must apply for a USDOT number and, if applicable, operating authority using the URS online application, available at http://www.fmcsa.dot.gov/urs. These applications will be processed using the same legacy systems available to FMCSA today, and will be transitioned over to the complete URS database with those records that already exist in the legacy systems. Applicants will have the ability to print out a summary of their online application after their application is complete and their fee is paid.

Section 368.8 also has a minor change. We have removed the last sentence, which indicated that the Director's decision would serve as the final Agency order in appeals after denials of applications. However, the Director no longer has the authority to make these decisions, as that authority has been redelegated to the Assistant Administrator. The change is being made to the regulation to reflect this change in delegation.

This final rule delays the effective date for the revisions in sections 385.301, 385.303, 385.305, 385.329, 385.405, 385.409, 385.419, 385.421, 385.603, 385.607, 385.609, and 385.713 until September 30, 2016, when FMCSA estimates the URS online application will be available for all users, and the majority of the functionality of the URS will be fully available. No additional changes have been made to the provisions found in the listed sections; they appear here as they did in the August 23, 2013 URS final rule.

This final rule delays the effective date for the revisions in sections 387.19, 387.33, 387.43, 387.301, 387.303, 387.313, 387.323, 387.403, 387.413, and 387.419 until September 30, 2016, when FMCSA estimates the URS online application will be available for all users, and the majority of the functionality of the URS will be fully available.

It also provides for a three-month compliance period for private hazardous materials and exempt for-hire motor carriers, registered with FMCSA as of September 30, 2016, to complete their electronic filing requirements. This compliance period ends on December 31, 2016. These provisions can be found in sections 387.19 and 387.43. The URS will have the ability to collect the financial responsibility filings for private hazardous materials and exempt for-hire motor carriers on September 30, 2016. We encourage insurers of these motor carriers to comply as early as they can. Note that after September 30, 2016, new applicants (i.e., entities that have not registered with FMCSA prior to September 30, 2016) will be required to submit their evidence of meeting the financial responsibility requirements before registration will be granted.

This final rule adds a change to § 387.403. On October 1, 2013, FMCSA issued a final rule to implement section 32918 of MAP-21, which amended 49 U.S.C. 13906 to require a minimum surety bond or trust fund of $75,000 and extended the bond requirement from brokers to freight forwarders. The October 1 final rule added paragraph (c) to § 387.403 to implement this change. It was not reflected in the August 23, 2013, URS final rule, and without this change, new paragraph (c) would be removed when today's final rule goes into effect. We have therefore revised § 387.403 to include paragraph (c) to ensure it remains intact after today's rule goes into effect.

This final rule will delay the effective dates for the amendments to sections 390.3, 390.5, 390.19,11 390.21, 390.40, 390.201, 390.203, 390.205, 390.207, and 390.209.

This final rule also adds temporary Subpart E, consisting of § 390.T200, which will be in effect from December 12, 2015, through September 29, 2016. Under this temporary section, new applicants, defined as entities who do not have (and have never had) an active USDOT Number, must apply for a USDOT Number using the URS online application, available at http://www.fmcsa.dot.gov/urs. These applications will be processed using the same legacy systems available to FMCSA today, and will be transitioned over to the complete URS database with those records that already exist in the legacy systems. Applicants will have the ability to print out a summary of their online application after their application is complete.

This final rule incorporates a number of corrections to § 390.3 that were made in a correcting document published on October 23, 2013.12 Because these corrections appear in the regulatory text laid out below, we are withdrawing the associated amendatory instructions from the October 23, 2013, correcting document. This change has no impact, but is necessary to ensure proper codification of the provisions in the Code of Federal Regulations. This final rule is also correcting an erroneous cross reference that was included in the August 23, 2013, final rule. In § 390.207(c), there is a cross reference to Subpart D as applying to intermodal equipment providers. This is incorrect; Subpart D covers the National Registry of Certified Medical Examiners. Subpart C of Part 390 is the appropriate cross reference, as it covers “Requirements and Information for Intermodal Equipment Providers and for Motor Carriers Operating Intermodal Equipment.” FMCSA is also correcting the authority citation for part 390. The August 23, 2013, final rule inadvertently omitted some of the statutory authorities granted to FMCSA, and today's final rule is adding them back. As these authorities have remained in effect, there is no substantive impact from this change.

Today's final rule corrects the authority citation for part 392. The August 23, 2013, final rule inadvertently omitted some of the statutory authorities granted to FMCSA, and today's final rule is adding them back. As these authorities have remained in effect, there is no substantive impact from this change.

FMCSA has determined that today's final rule delaying the effective date of the URS rules is not a significant regulatory action within the meaning of E.O. 12866, as supplemented by E.O. 13563, or within the meaning of DOT regulatory policies and procedures. We do not expect today's final rule to have any new costs; today's action delaying the effective date will also delay the associated costs of the August 23, 2013, final rule. As discussed previously, this delay action is necessary because the URS technological solution, required to implement the URS final rule, is not ready. Not delaying the URS final rule may result in additional costs, as allowing the URS final rule to come into effect without having the required technological pieces (such as the URS online application and the integrated database required by statute) would require motor carriers, freight forwarders, brokers, and others to use a system that does not exist, with no alternative for seeking registration authorities. This could lead to a delay in processing registrations, which could then impact the applicants. Delaying the effective date of the URS final rule avoids these potential costs, without adding new costs over what was originally estimated in the August 2013 RIA. The August 2013 RIA can be found in the docket for today's final rule.

Under the Regulatory Flexibility Act of 1980 (RFA) (5 U.S.C. 601-612), FMCSA is not required to complete a regulatory flexibility analysis. This is because this rule does not require publication of a general notice of proposed rulemaking. However, in compliance with the RFA, FMCSA has evaluated the effects of today's final rule on small entities, and determined that delaying the effective date for the URS final rule will not result in a significant economic impact on a substantial number of small entities. Accordingly, the Administrator of FMCSA hereby certifies that this rule will not have a significant economic impact on a substantial number of small entities.

Today's final rule will not impose an unfunded Federal mandate, as defined by the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1532, et seq.), that will result in the expenditure by State, local and tribal governments, in the aggregate, or by the private sector, of $155 million (which is the value of $100 million in 1995 after adjusting for inflation) or more in any 1 year.

The Agency analyzed today's final rule for the purpose of the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321 et seq.) and determined under our environmental procedures Order 5610.1, issued March 1, 2004 (69 FR 9680), that this action is categorically excluded (CE) under Appendix 2, paragraphs 6(e), 6(h) and 6(y)(2) of the Order from further environmental documentation. The CE under Appendix 2, paragraph 6(e) relates to establishing regulations and actions taken pursuant to the requirements concerning applications for operating authority and certificates of registration. The CE under Appendix 2, paragraph 6(h), relates to establishing regulations and actions taken pursuant to the requirements implementing procedures to collect fees that will be charged for motor carrier registrations and insurance for the following activities: (1) Application filings; (2) records searches; and (3) reviewing, copying, certifying, and related services. The CE under Appendix 2, paragraph 6(y)(2), addresses regulations implementing motor carrier identification and registration reports. In addition, the Agency believes that this rule includes no extraordinary circumstances that will have any effect on the quality of the human environment. Thus, today's rule does not require an environmental assessment or an environmental impact statement.

FMCSA also has analyzed today's rule under the Clean Air Act, as amended (CAA), section 176(c) (42 U.S.C. 7401 et seq.), and implementing regulations promulgated by the Environmental Protection Agency. Approval of this action is exempt from the CAA's general conformity requirement because it involves policy development and rulemaking activities regarding registration of regulated entities with FMCSA for commercial, safety and financial responsibility purposes. See 40 CFR 93.153(c)(2)(vi). The changes would not result in any emissions increases, nor will they have any potential to result in emissions that are above the general conformity rule's de minimis emission threshold levels. Moreover, it is reasonably foreseeable that the actions will not increase total CMV mileage or change the routing of CMVs, how CMVs operate, or the CMV fleet-mix of motor carriers.

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), a Federal Agency must obtain approval from OMB for each collection of information it conducts, sponsors, or requires through regulations. The FMCSA analyzed the August 23, 2013, final rule and determined that its implementation would streamline the information collection burden on motor carriers and other regulated entities, relative to the baseline, or current paperwork collection processes. This included streamlining the FMCSA registration, insurance, and designation of process agent filing processes and implementing mandatory electronic online filing of these applications, as well as eliminating some outdated filing requirements. A full analysis of the impacted collections of information, both existing and new, can be found in that final rule,13 a copy of which is in the docket for today's final rule. Today's final rule makes no changes to the collections described in that final rule.

Today's final rule will not effect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

Today's final rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

Executive Order 13045, “Protection of Children from Environmental Health Risks and Safety Risks” (April 23, 1997, 62 FR 19885), requires that agencies issuing economically significant rules, which also concern an environmental health or safety risk that an Agency has reason to believe may disproportionately affect children, must include an evaluation of the environmental health and safety effects of the regulation on children. Section 5 of Executive Order 13045 directs an Agency to submit for a covered regulatory action an evaluation of its environmental health or safety effects on children. Today's final rule is not an economically significant rule and will not create an environmental risk to health or risk to safety that might disproportionately affect children.

This rule has been analyzed in accordance with the principles and criteria in Executive Order 13132, dated August 4, 1999 (64 FR 43255, August 10, 1999). The FMCSA consulted with State licensing agencies participating in its PRISM Program to discuss anticipated impacts of the May 2005 NPRM upon their operations. The Agency has taken into consideration their comments in its decision-making process for this rule. Thus, FMCSA has determined that this rule will not have significant Federalism implications or limit the policymaking discretion of the States.

The regulations implementing Executive Order 12372 regarding intergovernmental consultation on Federal programs and activities do not apply to today's final rule.

FMCSA has analyzed this rule under Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use,” and has determined that this is not a significant energy action within the meaning of section 4(b) of the Executive Order. Today's final rule is not economically significant, and will not have a significant adverse effect on the supply, distribution, or use of energy.

The FMCSA conducted a privacy impact assessment of the August 23, 2013, final rule as required by section 522(a)(5) of division H of the FY 2005 Omnibus Appropriations Act, Public Law 108-447, 118 Stat. 3268 (Dec. 8, 2004) [set out as a note to 5 U.S.C. 552a]. The assessment considered any impacts of the final rule on the privacy of information in an identifiable form and related matters. FMCSA determined that the August 23, 2013, final rule will impact the handling of personally identifiable information (PII). FMCSA also determined the risks and effects the rulemaking might have on collecting, storing, and sharing PII and examined and evaluated protections and alternative information handling processes in order to mitigate potential privacy risks. Today's final rule makes no changes to the information being collected, or to the manner that it is stored and shared. FMCSA believes that the PIA for the August 23, 2013, final rule adequately covers today's action; that PIA remains available for review in the docket for today's final rule.

In consideration of the foregoing, FMCSA is amending 49 CFR chapter III, subchapter B, parts 360, 365, 366, 368, 385, 387, 390, and 392, as set forth below: