Federal Register Vol. 81, No.29,

FDA is removing two regulations that prescribe procedures for FDA's review and classification of biological products licensed before July 1, 1972, because the two regulations are obsolete and no longer necessary in light of other statutory and regulatory authorities established since 1972. These other statutory and regulatory authorities allow FDA to evaluate and monitor the safety and effectiveness of all biological products and authorize FDA to revoke a license for products because they are not safe and effective, or are misbranded.

The final rule removes §§ 601.25 and 601.26 (21 CFR 601.25 and 601.26), which prescribe procedures for FDA's review and classification of biological products licensed before July 1, 1972.

FDA is taking this action under the biological products provisions of the Public Health Service Act (the PHS Act), and the drugs and general administrative provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act).

Because this final rule would not impose any additional regulatory burdens, this regulation is not anticipated to result in any compliance costs and the economic impact is expected to be minimal.

In the Federal Register of July 2, 2015 (80 FR 38145), FDA proposed to remove regulations that prescribe procedures for FDA's review and classification of biological products licensed before July 1, 1972. As discussed in the preamble to the proposed rule, these regulations were originally issued after the Director of the National Institutes of Health (NIH) announced in the Federal Register on March 15, 1972, that the Division of Biologics Standards, NIH, would review the effectiveness of all licensed biologicals (37 FR 5404). In the Federal Register of June 29, 1972 (37 FR 12865), FDA announced the transfer of regulatory authority over biological products from the Division of Biologics Standards, NIH, to FDA. After obtaining regulatory authority over biological products, the Commissioner of FDA proposed procedures for reviewing the safety, effectiveness, and labeling of all biological products licensed at the time of the transfer on July 1, 1972 (37 FR 16679, August 18, 1972). The procedures for review of biological products licensed before July 1, 1972, were codified in 21 CFR 273.245 (38 FR 4319 at 4321, February 13, 1973) and later redesignated to § 601.25 (38 FR 32048, November 20, 1973). The procedures for review of biological products licensed before July 1, 1972, were supplemented by procedures codified in § 601.26 (47 FR 44062, October 5, 1982).

Since establishing the procedures under §§ 601.25 and 601.26, FDA developed new regulations to assess and ensure the safety and efficacy of biological products. FDA issued the Current Good Manufacturing Practice (cGMP) regulations, which contain the minimum cGMP for preparation of drug products, including biological products. The cGMP regulations help FDA ensure that such products meet the requirements for product safety, effectiveness, and labeling. FDA also helps ensure the safety and effectiveness of biological products through application of other regulations, such as the reporting of biological product deviations by licensed manufacturers (see 21 CFR 600.14), postmarketing reporting of adverse experiences (21 CFR 600.80), and labeling regulations (for example, 21 CFR part 201). Biological products that do not meet the requirements under these regulations are subject to license revocation under 21 CFR 601.5, which allows FDA to revoke any biologics license for a product that fails to meet applicable standards and fails to comply with regulations designed to help ensure the safety, purity, and potency of the licensed product, and that the product is not misbranded.

In addition, FDA continues to help ensure the safety and effectiveness of licensed biological products through the development and application of additional standards and mechanisms. These mechanisms assist FDA in evaluating and monitoring the safety and effectiveness of biological products.

FDA did not receive any comments on the proposed rule.

The final rule removes §§ 601.25 and 601.26 of the regulations, which prescribe procedures for FDA's review and classification of biological products licensed before July 1, 1972. FDA is taking this action because these regulations are obsolete and no longer necessary in light of other statutory and regulatory authorities established since 1972, which allow FDA to evaluate and monitor the safety and effectiveness of all biological products.

FDA is issuing this regulation under the biological products provisions of the PHS Act (42 U.S.C. 262 and 264) and the drugs and general administrative provisions of the FD&C Act (sections 201, 301, 501, 502, 503, 505, 510, 701, and 704 (21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 371, and 374)). Under these provisions of the PHS Act and the FD&C Act, we have the authority to issue and enforce regulations designed to ensure that biological products are safe, pure, and potent; and to prevent the introduction, transmission, and spread of communicable disease.

We have examined the impacts of the final rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct Agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). We believe that this final rule is not a significant regulatory action as defined by Executive Order 12866.

The Regulatory Flexibility Act requires Agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because this final rule removes regulations that are obsolete and no longer necessary in light of other current statutory and regulatory authorities, FDA certifies that the final rule will not have a significant economic impact on a substantial number of small entities.

The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before issuing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $144 million, using the most current (2014) Implicit Price Deflator for the Gross Domestic Product. This final rule would not result in any 1-year expenditure that would meet or exceed this amount.

We have determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant adverse effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

This final rule contains no collection of information. Therefore, clearance by OMB under the Paperwork Reduction Act of 1995 is not required.

We have analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies that would 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. Accordingly, the Agency has concluded that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.

Therefore, under the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 601 is amended as follows:

The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments) (Pub. L. 94-295), the Safe Medical Devices Act of 1990 (Pub. L. 101-629), the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L. 105-115), the Medical Device User Fee and Modernization Act of 2002 (Pub. L. 107-250), the Medical Devices Technical Corrections Act (Pub. L. 108-214), the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85), and the Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-144), among other amendments, established a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the FD&C Act (21 U.S.C. 360c) established three categories (classes) of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval).

Under section 513(d) of the FD&C Act, devices that were in commercial distribution before the enactment of the 1976 amendments, May 28, 1976 (generally referred to as preamendments devices), are classified after FDA has: (1) Received a recommendation from a device classification panel (an FDA advisory committee); (2) published the panel's recommendation for comment, along with a proposed regulation classifying the device; and (3) published a final regulation classifying the device. FDA has classified most preamendments devices under these procedures.

Devices that were not in commercial distribution prior to May 28, 1976 (generally referred to as postamendments devices) are automatically classified by section 513(f) of the FD&C Act into class III without any FDA rulemaking process. Those devices remain in class III and require premarket approval unless, and until, the device is 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).

A preamendments device that has been classified into class III and devices found substantially equivalent by means of premarket notification procedures (510(k)) to such a preamendments device or to a device within that type (both the preamendments and substantially equivalent devices are referred to as preamendments class III devices) may be marketed without submission of a premarket approval application (PMA) until FDA issues a final order under section 515(b) of the FD&C Act (21 U.S.C. 360e(b)) requiring premarket approval or until the device is subsequently reclassified into class I or class II.

On July 9, 2012, FDASIA was enacted. Section 608(a) of FDASIA (126 Stat. 1056) amended section 513(e) of the FD&C Act, changing the mechanism for reclassifying a device from rulemaking to an administrative order.

Section 513(e) of the FD&C Act provides that FDA may, by administrative order, reclassify a device based upon “new information.” FDA can initiate a reclassification under section 513(e) of the FD&C Act or an interested person may petition FDA to reclassify a preamendments device. The term “new information,” as used in section 513(e) of the FD&C Act, includes information developed as a result of a reevaluation of the data before the Agency when the device was originally classified, as well as information not presented, not available, or not developed at that time. (See, e.g., Holland-Rantos Co. v. United States Department of Health, Education, and Welfare, 587 F.2d 1173, 1174 n.1 (D.C. Cir. 1978); Upjohn v. Finch, 422 F.2d 944 (6th Cir. 1970); Bell v. Goddard, 366 F.2d 177 (7th Cir. 1966).)

Reevaluation of the data previously before the Agency is an appropriate basis for subsequent action where the reevaluation is made in light of newly available authority (see Bell, 366 F.2d at 181; Ethicon, Inc. v. FDA, 762 F.Supp. 382, 388-391 (D.D.C. 1991)), or in light of changes in “medical science” (Upjohn, 422 F.2d at 951). Whether data before the Agency are old or new data, the “new information” to support reclassification under section 513(e) of the FD&C Act must be “valid scientific evidence,” as defined in section 513(a)(3) of the FD&C Act and 21 CFR 860.7(c)(2). (See, e.g., General Medical Co. v. FDA, 770 F.2d 214 (D.C. Cir. 1985); Contact Lens Manufacturers Assoc. v. FDA, 766 F.2d 592 (D.C. Cir. 1985), cert. denied, 474 U.S. 1062 (1986).)

FDA relies upon “valid scientific evidence” in the classification process to determine the level of regulation for devices. To be considered in the reclassification process, the “valid scientific evidence” upon which the Agency relies must be publicly available. Publicly available information excludes trade secret and/or confidential commercial information, e.g., the contents of a pending PMA (see section 520(c) of the FD&C Act (21 U.S.C. 360j(c)).)

Section 513(e)(1) of the FD&C Act sets forth the process for issuing a final reclassification order. Specifically, prior to the issuance of a final order reclassifying a device, the following must occur: (1) Publication of a proposed order in the Federal Register; (2) a meeting of a device classification panel described in section 513(b) of the FD&C Act; and (3) consideration of comments to a public docket.

FDA published a proposed order to reclassify this device in the Federal Register of January 8, 2013 (78 FR 1158) (the “proposed order”). As noted in the proposed order, on July 16, 1982, the Agency issued a final rule classifying all membrane lungs for long-term pulmonary support into class III (47 FR 31130). On May 11, 1987, FDA published a final rule amending the codified language for this device to clarify that no effective date had been established for the requirement for premarket approval for membrane lungs for long-term pulmonary support devices (52 FR 17732 at 17735). This device is currently under product code BYS.

As discussed in the proposed order, FDA considered the available information on these devices and concluded that these devices could be reclassified to class II, subject to the identified special controls. As required by section 513(e)(1) of the FD&C Act, FDA convened a meeting of a device classification panel described in section 513(b) of the FD&C Act with respect to the membrane lung devices for long-term pulmonary support on September 12, 2013, followed by a meeting on May 7, 2014. The deliberations of the device classification panels are discussed in section IV of this order. FDA received and has considered two comments on the January 8, 2013, proposed order, as discussed in section III. Therefore, FDA has met the requirements for issuing a final order under section 513(e)(1) of the FD&C Act.

FDA received two comments in response to the January 8, 2013, proposed order to reclassify membrane lung devices for long-term pulmonary support for conditions where imminent death is threatened by cardiopulmonary failure in neonates and infants or where cardiopulmonary failure results in the inability to separate from cardiopulmonary bypass following cardiac surgery.

One comment supported FDA's reclassification proposal but requested that the Agency clarify the population covered and the conditions included in the reclassification. According to the commenter, it seemed that the membrane lung device could be used for long-term support in neonates and infants only when imminent death is threatened by cardiopulmonary failure, but for the remaining population (e.g., pediatric and adult patients), the membrane lung could be used for long-term support only when cardiopulmonary failure results in the inability to separate from cardiopulmonary bypass following cardiac surgery. With respect to the conditions covered, the commenter sought clarification as to whether the reclassification was limited only to cardiopulmonary conditions or to cardiac failure as well. FDA is clarifying the intended uses covered by the reclassification in this final order. Specifically, after considering the input from the September 12, 2013, and May 7, 2014, classification panel meetings, comments on the proposed order and all other available information, FDA has determined that the reclassification applies to ECMO as a system of devices and accessories that provide extracorporeal circulation and physiologic gas exchange of blood in patients with acute respiratory failure or acute cardiopulmonary failure where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. This revised scope better reflects use of ECMO as a tool that provides extracorporeal circulation and physiologic gas exchange of blood and more accurately reflects the function of the device. FDA has not cleared any ECMO devices that are indicated for specific patient populations or conditions. As such, FDA believes that the intended uses included in this final order should remain broad, rather than specify patient populations or conditions to be treated, to reflect use of ECMO as a tool.

Another comment disagreed with FDA's intent to reclassify membrane lung devices for long-term pulmonary support, stating that “ECMO devices must remain categorized as class III devices for all indications because they are life-sustaining devices for which clinical trials are necessary to provide reasonable assurance of safety and effectiveness.” FDA disagrees with this comment. According to section 513(a)(1)(C) of the FD&C Act, a class III device is defined as a device which: (1) Cannot be classified as a class I device because insufficient information exists to determine that the application of general controls are sufficient to provide reasonable assurance of the safety and effectiveness of the device; and (2) cannot be classified as a class II device because insufficient information exists to determine that the special controls would provide reasonable assurance of its safety and effectiveness; and (3) is purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health; or (4) presents a potential unreasonable risk of illness or injury.

Although FDA considers membrane lung devices for long-term pulmonary support to be life-supporting, a viewpoint that was supported by the panel members at the September 12, 2013 (2013 Panel), and May 7, 2014 (2014 Panel), device classification panel meetings, FDA believes that the available information supports FDA's determination that special controls, in addition to general controls, would be sufficient to provide a reasonable assurance of safety and effectiveness. Further, the 2013 and 2014 Panels largely supported reclassification of ECMO for use in patients with acute respiratory failure or acute cardiopulmonary failure as noted in section IV of this order. As mentioned previously and discussed further in section IV, ECMO is a tool which provides extracorporeal circulation and physiologic gas exchange of blood. The special controls identified in this final order, including clinical performance data, ensure that the device can function as intended to provide extracorporeal circulation and physiologic gas exchange of blood for the intended duration of device use. The Agency believes that the risks of ECMO devices are sufficiently understood based on valid scientific evidence and that the risks of ECMO devices can be mitigated with the special controls identified in this final order. The special controls mitigate the risks to health identified for the device as outlined in section IV, table 1. Therefore, FDA does not agree that membrane lung devices for long-term pulmonary support for use in patients with acute respiratory failure or acute cardiopulmonary failure should remain a class III device.

The commenter also expressed concern that the reclassification of these devices would mean that companies manufacturing new versions of the device would not be required to show that their products are safe and effective. The commenter suggests that classification to class II (special controls) precludes FDA from requesting clinical data for these devices. FDA disagrees with this comment. FDA believes that the identified special controls provide a reasonable assurance of safety and effectiveness for membrane lung devices for long-term pulmonary support for use in patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. FDA has determined that by complying with the identified special controls, the currently legally marketed devices within this classification regulation will be reasonably safe and effective when used for acute respiratory failure or acute cardiopulmonary failure. Future devices claiming substantial equivalence to an available predicate(s) must demonstrate that they are substantially equivalent, as defined under section 513(i) of the FD&C Act, to the predicate device and comply with all applicable FDA regulations and with the special controls in order to be classified into class II. Classification to class II (special controls) does not preclude FDA from requesting clinical data for these devices. In some cases, clinical data may be needed to comply with the special controls and demonstrate substantial equivalence to an available predicate. For example, special control § 870.4100(b)(v) regarding in vivo evaluation of the device could include clinical trial data, clinical information from the literature, and/or animal study data.

The commenter further expressed concern that reclassification for some indications will reduce the incentive to undertake future studies for untested indications due to the availability of the devices for “off-label” use. FDA notes in response to this comment that, generally, FDA regulates the use of a device as indicated by the party offering the device for interstate commerce.

The commenter also sought assurance from FDA that membrane lung devices for long-term pulmonary support for indications not identified in the proposed order would remain in class III and therefore require the submission of a PMA. FDA notes that by identifying the intended uses covered by the revised classification regulation, uses that fall outside the definition would not be subject to the order but rather would be classified under section 513 of the FD&C Act.

As required by section 513(e)(1) of the FD&C Act, FDA convened a meeting of the Circulatory System Devices Panel to consider the existing valid scientific evidence to support reclassification to class II of membrane lung devices for long-term pulmonary support. One meeting was held on September 12, 2013 (2013 Panel), regarding pediatric uses for ECMO and another meeting was held on May 7, 2014 (2014 Panel), regarding adult uses for ECMO (Refs. 1 and 2).

On September 12, 2013, FDA presented the risks associated with use of the membrane lung device for long-term pulmonary support. The 2013 Panel mostly agreed that the risks to health were adequately captured as presented by FDA. Several 2013 Panel members discussed whether the list of risks to health should also include information on renal dysfunction, neurologic injury, disseminated intravascular coagulation, transfusion issues, and inflammatory responses. FDA explained that such effects are more appropriately characterized not as risks to health but rather as adverse events that may result from the risks to health. The 2013 Panel understood this distinction but requested that FDA consider expanding the definition of adverse tissue reaction to include inflammatory response. FDA considered the 2013 Panel's input when updating the risks to health for the 2014 Panel and this final order.

The 2013 Panel agreed that the available scientific evidence supported the safety and effectiveness for ECMO and its accessories for conditions where the subject is at threat of imminent death caused by acute reversible respiratory failure (e.g., meconium aspiration, congenital diaphragmatic hernia, pulmonary hypertension) in neonates and infants, or where acute cardiopulmonary failure results in the inability to separate from cardiopulmonary bypass following cardiac surgery in all pediatric patients.

The 2013 Panel also agreed that the probable benefits to health from use of the extracorporeal circuit and its accessories for long-term pulmonary and cardiopulmonary support for these uses outweigh the probable risks. As noted previously, FDA has further considered all available information and has determined that the risks to health identified for ECMO are the same across neonatal, infant, pediatric, and adult populations. This is consistent with input from the 2013 and 2014 Panels, which found that the risks to health for the pediatric and adult populations do not differ. Further, FDA believes that the available safety and effectiveness information supports use of ECMO as a tool to provide extracorporeal circulation and physiologic gas exchange of blood in patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. FDA is providing greater clarity in this final order by simplifying the identification of ECMO devices in the classification regulation to better reflect what an ECMO circuit performs, not specify patient populations or conditions to be treated. Specific indications for use for ECMO, including specific patient populations and/or conditions, are further discussed in this document.

In general, the 2013 Panel believed the special controls in the proposed order would mitigate the identified risks to health and provide reasonable assurance of safety and effectiveness of the extracorporeal circuit and its accessories. However, some 2013 Panel members recommended that compatibility of the various circuit accessories be evaluated to ensure that the circuit accessories can function together as intended. FDA believes that the special controls will be able to address the issue of circuit accessories' compatibility. Specifically, the following special controls from the classification regulation address this concern: (1) The design characteristics of the device must ensure that the geometry and design parameters are consistent with the intended use; (2) non-clinical performance evaluation of the device must demonstrate substantial equivalence for performance characteristics on the bench, mechanical integrity, electromagnetic compatibility(where applicable), software, durability, and reliability; and (3) labeling must include a detailed summary of the non-clinical and clinical evaluations pertinent to use of the device and adequate instructions with respect to anticoagulation, circuit setup, performance characteristics with respect to compatibility with other circuit accessories, and maintenance during a procedure.

The 2013 Panel unanimously agreed that the membrane lung device for long-term pulmonary support is life-supporting. The 2013 Panel further stated that the available scientific evidence and the proposed special controls, in conjunction with general controls, supported the reclassification to class II of membrane lung devices for long-term pulmonary/cardiopulmonary support in pediatric patients. The 2013 Panel expressed concern about not having had the opportunity to review data regarding use of the device in adults, given that use of ECMO in adults had increased significantly over the years. The 2013 Panel recommended that FDA convene another meeting to review the available literature regarding use of the membrane lung device for long-term pulmonary support in adults before finalizing the proposed reclassification.

On May 7, 2014, FDA convened the 2014 Panel to discuss the classification of the membrane lung for long-term support, specifically for adult pulmonary and cardiopulmonary indications. For both pulmonary and cardiopulmonary intended uses, the 2014 Panel believed that the list of risks to health presented by FDA were comprehensive and adequately captured. Of note, in response to the 2013 Panel's recommendation regarding risks to health, FDA expanded the definition of adverse tissue reaction to include inflammatory response.

The majority of the 2014 Panel believed that the available scientific evidence is adequate to support a reasonable assurance of safety and effectiveness of the extracorporeal circuit and its accessories for long-term pulmonary support in adults, but recommended that FDA modify the intended use from “pulmonary support” to “acute, hypoxic, reversible respiratory failure.” FDA agrees with the 2014 Panel that “respiratory failure” is a more accurate reflection of the use of ECMO as a tool to provide extracorporeal circulation and physiologic gas exchange of blood in patients rather than “pulmonary support.” FDA has considered this input from the panel and has determined that acute respiratory failure is the appropriate intended use from a clinical and regulatory perspective to reflect such use. This change is reflected in the classification regulation. The Panel also agreed that the available scientific evidence is adequate to support a reasonable assurance of safety and effectiveness of the device for long-term cardiopulmonary support in adults suffering from “cardiopulmonary failure due to acute catastrophic cardiogenic shock.” FDA agrees with the 2014 Panel that “acute cardiopulmonary failure” is a more accurate reflection of the use of ECMO as a tool to provide extracorporeal circulation and physiologic gas exchange of blood in patients rather than “cardiopulmonary support.” FDA has considered this input from the panel and has determined that acute cardiopulmonary failure is the appropriate intended use from a clinical and regulatory perspective to reflect such use. This change is reflected in the classification regulation. For both pulmonary and cardiopulmonary support in adults, the 2014 Panel agreed that the probable benefits to health from use of the device outweigh the probable risks to health where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent.

The 2014 Panel agreed that FDA's list of special controls were appropriate and comprehensive. The 2014 Panel further agreed that the special controls would mitigate the identified risks to health and provide reasonable assurance of safety and effectiveness for the device when used to provide long-term support in adults with acute respiratory failure or cardiopulmonary failure.

For both acute respiratory and acute cardiopulmonary indications in adults, the 2014 Panel unanimously agreed that the membrane lung device for long-term support is life-supporting. The 2014 Panel further believes that the available scientific evidence and the proposed special controls support the reclassification to class II of membrane lung devices for long-term support in adults with acute respiratory failure or acute cardiopulmonary failure.

After considering input from both the 2013 and 2014 Panels, FDA believes that the risks to health identified can be mitigated by the special controls as outlined in Table 1.

At both the 2013 Panel and 2014 Panel meetings, FDA provided a summary of information from the clinical literature regarding specific patient populations and conditions to be treated using ECMO (Refs.1 and 2). Of note, FDA has not cleared any ECMO devices that are indicated for specific patient populations or conditions. As such, FDA believes that the intended uses included in this final order should remain broad to reflect use of ECMO as a tool to provide extracorporeal circulation and physiologic gas exchange of blood in patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. However, FDA believes that there are specific indications (patient populations and/or conditions) that would fall within this broader intended use and therefore be within the scope of this regulation as outlined in this document.

Specifically, FDA has reviewed the clinical literature and has determined that there are sufficient data available to support labeling ECMO devices for the following specific indications (patient populations and/or conditions) at this time: Meconium aspiration in neonates and infants; congenital diaphragmatic hernia in neonates and infants; pulmonary hypertension in neonates and infants; failure to wean from cardiopulmonary bypass following cardiac surgery in pediatric and adult patients; and ECMO-assisted cardiopulmonary resuscitation in adults.

FDA has further evaluated data from the clinical literature and determined that the data available do not support labeling ECMO devices for certain specific indications (patient populations and/or conditions) at this time without additional clinical data from sponsors to support such uses, consistent with the identified special controls, including but not limited to: High risk percutaneous coronary intervention; trauma resuscitation; failed heart or lung transplant; acute respiratory distress syndrome; and/or acute decompensation of chronic obstructive pulmonary disease.

For ECMO devices that have not been legally marketed prior to the effective date of the final order, or models (if any) that have been legally marketed but are required to submit a new 510(k) under § 807.81(a)(3) because the device is about to be significantly changed or modified, manufacturers must obtain 510(k) clearance, among other relevant requirements, and demonstrate compliance with the special controls included in the final order, before marketing the new or changed device.

Under section 513(e) of the FD&C Act, FDA is adopting its findings as published in the preamble to the proposed order (78 FR 1158) with modifications as discussed in section IV of this final order. FDA is issuing this final order to reclassify the membrane lung devices for long-term pulmonary support from class III to class II for use in patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent, and to establish special controls. FDA is removing the regulation from 21 CFR part 868 (Anesthesiology Devices) and adding it to 21 CFR part 870 (Cardiovascular Devices) to better align this device type (and the review thereof) with other similar types of cardiovascular devices. The title and identification of § 870.4100 (21 CFR 870.4100) reflects the Agency's intent to regulate ECMO and the accessories used in ECMO under the same set of regulatory controls. However, an individual device or accessory in an ECMO circuit may already have its own classification regulation when intended for short-term use (≤6 hours) and, in those instances, such device or accessory is subject to the preexisting regulation(s).

Following the effective date of this final order, firms marketing membrane lung devices for long-term pulmonary support for use in patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent, must comply with the particular mitigation measures set forth in the special controls.

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 devices. FDA has determined that premarket notification is necessary to provide reasonable assurance of safety and effectiveness of membrane lung devices for long-term pulmonary support for use in patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent, and, therefore, this device type is not exempt from premarket notification requirements.

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 refers to previously approved collections of information found in 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 21 CFR part 812 have been approved under OMB control number 0910-0078; the collections of information in 21 CFR part 807, subpart E, have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 814, subpart B, have been approved under OMB control number 0910-0231; and the collections of information under 21 CFR part 801 have been approved under OMB control number 0910-0485.

Prior to the amendments by FDASIA, section 513(e) of the FD&C Act provided for FDA to issue regulations to reclassify devices. Although section 513(e) of the FD&C Act as amended requires FDA to issue final orders rather than regulations, FDASIA also provides for FDA to revoke previously issued regulations by order. FDA will continue to codify classifications and reclassifications in the Code of Federal Regulations (CFR). Changes resulting from final orders will appear in the CFR as changes to codified classification determinations or as newly codified orders. Therefore, under section 513(e)(1)(A)(i) of the FD&C Act, as amended by FDASIA, in this final order, we are revoking the requirements in 21 CFR 868.5610 related to the classification of membrane lung for long-term pulmonary support as class III devices and codifying under § 870.4100 the reclassification of membrane lung for long-term pulmonary support for use in patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent into class II (special controls).

The following references are on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at http://www.regulations.gov. FDA has verified the Web site addresses, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 868 and 870 are amended as follows:

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) of the FD&C Act. 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 March 6, 2015, Target Health, Inc. (on behalf of Dignitana AB) submitted a request for classification of the DigniCapTM Scalp Cooling System 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) of the FD&C Act. 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 and the medical literature, if applicable, FDA determined that the device can be classified into class II with the establishment of special controls. FDA believes these special controls will provide reasonable assurance of the safety and effectiveness of the device.

Therefore, on December 8, 2015, FDA issued an order to the requestor classifying the device into class II. FDA is codifying the classification of the device by adding § 878.4360 (21 CFR 878.4360).

Following the effective date of this final classification order, any firm submitting a premarket notification (510(k)) for a scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia will need to comply with the special controls named in this final order.

The device is assigned the generic name scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia, and it is identified as a scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia intended to reduce the frequency and severity of alopecia during chemotherapy in which alopecia-inducing chemotherapeutic agents are used. The device is a prescription device.

FDA has identified the following risks to health associated with this type of device and the measures required to mitigate these risks:

FDA believes that the special controls in § 878.4360(b)(1) through (6), in addition to the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness.

Scalp cooling systems to reduce the likelihood of chemotherapy-induced alopecia are prescription devices restricted to patient use only upon the authorization of a practitioner licensed by law to administer or use the device; 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 scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia 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 is on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and is available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; it is also 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 878 is amended as follows:

The Department of State published an interim final rule on February 4, 2016 (81 FR 5906); this document corrects text in the ADDRESSES section and in the discussion of Executive Order 12866.

In the FR Doc 2016-02191, appearing on page 5906 in the Federal Register of February 4, 2016 (81 FR 5906):

1. In the second column of page 5906, third item under ADDRESSES, the term “XXXX” is corrected to read “9428.”

2. In the third column of page 5907, the first sentence of the discussion regarding “Executive Order 12866: Regulatory Review” is corrected to read: “The costs of this rulemaking are discussed in the companion DHS rule, RIN 1651-AB09, published in the Federal Register on February 8, 2016, 81 FR 6430.”

PBGC's regulation on Benefits Payable in Terminated Single-Employer Plans (29 CFR part 4022) prescribes actuarial assumptions—including interest assumptions—for paying plan benefits under terminating single-employer plans covered by title IV of the Employee Retirement Income Security Act of 1974. The interest assumptions in the regulation are also published on PBGC's Web site (http://www.pbgc.gov).

PBGC uses the interest assumptions in Appendix B to Part 4022 to determine whether a benefit is payable as a lump sum and to determine the amount to pay. Appendix C to Part 4022 contains interest assumptions for private-sector pension practitioners to refer to if they wish to use lump-sum interest rates determined using PBGC's historical methodology. Currently, the rates in Appendices B and C of the benefit payment regulation are the same.

The interest assumptions are intended to reflect current conditions in the financial and annuity markets. Assumptions under the benefit payments regulation are updated monthly. This final rule updates the benefit payments interest assumptions for March 2016.1

The March 2016 interest assumptions under the benefit payments regulation will be 1.25 percent for the period during which a benefit is in pay status and 4.00 percent during any years preceding the benefit's placement in pay status. In comparison with the interest assumptions in effect for February 2016, these interest assumptions are unchanged.

PBGC has determined that notice and public comment on this amendment are impracticable and contrary to the public interest. This finding is based on the need to determine and issue new interest assumptions promptly so that the assumptions can reflect current market conditions as accurately as possible.

Because of the need to provide immediate guidance for the payment of benefits under plans with valuation dates during March 2016, PBGC finds that good cause exists for making the assumptions set forth in this amendment effective less than 30 days after publication.

PBGC has determined that this action is not a “significant regulatory action” under the criteria set forth in Executive Order 12866.

Because no general notice of proposed rulemaking is required for this amendment, the Regulatory Flexibility Act of 1980 does not apply. See 5 U.S.C. 601(2).

In consideration of the foregoing, 29 CFR part 4022 is amended as follows:

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

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

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

EPA is finalizing SNURs, under TSCA section 5(a)(2), for three very long chain chlorinated paraffin (vLCCPs—alkyl chain length of C21 and above) chemical substances that were the subject of PMNs P-12-539, P-13-107, and P-13-109. This final rule requires persons who intend to manufacture or process any of these chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity.

In the Federal Register of August 7, 2013 (78 FR 48051) (FRL-9393-4), EPA issued direct final SNURs on these three chemical substances in accordance with the procedures at § 721.160(c)(3)(i). EPA received notices of intent to submit adverse comments on these SNURs. Therefore, as required by § 721.160(c)(3)(ii), EPA removed the direct final SNURs in a separate final rule published in the Federal Register of November 5, 2013 (78 FR 66279) (FRL-9902-16), and issued a proposed rule in the Federal Register of February 10, 2014 (79 FR 7621) (FRL-9903-43). The record for the direct final SNURs on these chemical substances was established as docket EPA-HQ-OPPT-2013-0399. That docket includes information considered by the Agency in developing the proposed and final rules, including comments on the proposed rule.

EPA received several comments on the proposed rules for these three chemical substances, from a single commenter representing chlorinated paraffin (CP) manufacturers (including the submitter of the PMNs that are the subject of these SNURs). A full discussion of EPA's response to these comments is included in Unit V. of this document. After consideration of these comments, because the potential remains for increased exposure that formed the basis for the proposed SNURs, EPA is issuing the final rules as they were proposed for the chemical substances.

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

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

During review of the PMNs submitted for the three chemical substances that are subject to these final SNURs, EPA concluded that regulation was warranted under TSCA section 5(e), pending the development of information sufficient to make reasoned evaluations of the health and environmental effects of the chemical substances. The basis for these findings is outlined in Unit IV of the proposed rule. Based on these findings, a TSCA section 5(e) consent order was negotiated with the PMN submitter that required manufacture of the substances at certain cumulative, aggregate volumes unless the company has submitted the results of certain environmental effects studies; no manufacture of the substances with the amount of chlorinated paraffins, with an alkyl chain less than or equal to 20, to exceed more than 1 percent of that PMN substance by weight; and risk notification. The SNUR provisions for these chemical substances are consistent with the provisions of the TSCA section 5(e) consent order. These final SNURs are issued pursuant to § 721.160. See the docket under docket ID number EPA-HQ-OPPT-2013-0399 for the corresponding consent order. For additional discussion of the rationale for the SNURs on these chemicals, see Units II., IV, and V. of the proposed rule.

EPA is issuing final SNURs for three chemical substances described above to achieve the following objectives with regard to the significant new uses designated in this final rule:

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

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

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

Issuance of a SNUR for a chemical substance does not signify that the chemical substance is listed on the TSCA Chemical Substance Inventory (TSCA Inventory). Guidance on how to determine if a chemical substance is on the TSCA Inventory is available on the Internet at http://www.epa.gov/tsca-inventory/about-tsca-chemical-substance-inventory.

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

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

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

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

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

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

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

EPA received comments from the Chlorinated Paraffins Industry Association (CPIA), which represents the CP industry, including the submitter of the PMN substances that are the subject of these SNURs and other chlorinated paraffin manufacturers. CPIA's comments, and associated attachments, can be found in the public docket under ID EPA-HQ-OPPT-2013-0399-0198.

Comment 1: Based on existing data and recent reviews, CPIA believes long chain chlorinated paraffin (LCCP—alkyl chain length of C18 to C20) production and use in the U.S. present an extremely low risk to human health and the environment. Given this, CPIA questions the need for EPA to take specific action under TSCA Section 5(a)(2) for any substances that could be considered LCCP. CPIA then provides information on why they believe LCCPs and vLCCPs do not present a risk.

Response: The comments primarily addressed the underlying risk assessments associated with the PMNs. EPA defers a discussion of the commenter's specific concerns as they are not relevant to the basis for determining that the uses specified in these SNURs constitute significant new uses. EPA is neither required to determine that a particular new use of any chemical substance presents, nor even that it may present, an unreasonable risk to human health or the environment. Rather, EPA issues a SNUR for a use of a substance if it is a significant new use (e.g., EPA has reason to anticipate that the use would raise significant questions related to potential exposure, so that the Agency should have an opportunity to review the use before such use should occur). EPA bases this judgment on a consideration of all relevant factors, including the specific factors identified at section 5(a)(2). Pursuant to TSCA section 5(a)(2), the PMN risk assessment does not serve as the basis for regulation of these SNURs, but as a valuable source of a breadth of information related to each substance's potential to threaten human health or the environment.

Nonetheless, EPA does have concern for these chemical substances because when released to the environment, vLCCPs are expected to rapidly partition to particulates and sediments where they are anticipated to persist in the environment with half-lives of months or greater. If they do degrade over time, these substances are expected to form shorter chain chlorinated chemicals. Based on the complex starting mixtures, lack of data on biological and abiotic reactions, and potential degradation products, there is high uncertainty regarding the fate and transport of these substances. Nevertheless, by analogy to medium chain chlorinated paraffins (MCCPs—alkyl chain length of C14 to C17) and LCCPs, EPA expects vLCCPs and possible degradation products to be potentially highly persistent, potentially highly bioaccumulative, and potentially toxic to aquatic and sediment-dwelling organisms. Further, within the category of vLCCPs, EPA expects the shorter carbon chain range of these substances (C21 to C24) and lower chlorinated substances (degree of chlorination less than 50%) to present the greatest potential for risk, as they are expected to be the most bioaccumulative, mobile in the environment, and toxic. Transport and magnification across trophic levels may also result in toxicity to higher organisms, including fish, higher predators, and potentially humans. EPA has concerns about the potential for the vLCCPs to degrade to shorter chain chlorinated compounds, as well as concerns about potential impurities or small fractions of MCCPs and/or LCCPs.

MCCPs and LCCPs are expected to be PBT chemicals based on the following lines of evidence: (a) The available data on MCCPs, sediment core studies, environmental fate studies, and associated calculations, indicate transformation half-lives of months to years, depending on the environmental media. Even though there are limited data on the LCCPs, biodegradation data indicated increasing stability with increasing chain length. LCCPs are also expected to have transformation half-lives comparable to, or greater than MCCPs. Therefore, MCCPs and LCCPs are expected to be very persistent; (b) The available data on MCCPs and LCCPs indicate that these substances have bioconcentration factors (BCFs) and bioaccumulation factors (BAFs) that exceed 1,000 or 5,000 liters per kilogram wet weight of tissue (L/kg ww). Therefore, MCCPs and LCCPs are expected to be very bioaccumulative; (c) The available data on MCCPs and LCCPs indicated acute and chronic toxicity to aquatic organism with effects levels below 10 milligrams per liter (mg/L) or 0.1 mg/L, depending on the species and MCCP and LCCP congener evaluated. Therefore, MCCPs and LCCPs are expected to be toxic to aquatic organisms; (d) EPA is concerned about PBT chemicals because even small releases may persist in environmental media, build up in the environment and concentrate/accumulate in organisms over time. These properties increase the potential for continual exposure, and thus risk; and (e) EPA expects there to be releases of the PMN substances to the environment resulting from distribution in commerce and during processing and all the substances' intended uses.

EPA notes that its risk assessments for certain MCCP and LCCP PMNs have recently been made available for public comment in the Federal Register of December 23, 2015 (80 FR 79886) (FRL-9940-13).

Comment 2: CPIA questioned the appropriateness of treating certain of the substances in the proposed SNUR as chemical analogs to LCCPs or vLCCPs, because two of the three substances covered by this SNUR are described as being “branched and linear” chloroalkanes: Alkanes, C21 to C34-branched and linear, chloro, CAS Registry Number (CASRN) 1417900-96-9 (P-12-0539), and Alkanes, C22 to C30-branched and linear, chloro, CASRN 1401974-24-0 (P-13-0107). CPIA could not find detailed compositional information about these substances in the rulemaking docket. Regardless, CPIA does not expect that anyone intending to make chlorinated paraffins would intentionally seek to make branched chloroalkanes. CP manufacturers have always used either n-paraffin or alpha-olefin feedstocks, both of which should be almost exclusively linear if they are to be used in CP manufacturing operations. To the extent that these hydrocarbon feedstocks contain branched or isoparaffin content, they are considered an impurity and something to be minimized and closely controlled. The Organisation for Economic Cooperation and Development (OECD) Screening Information Dataset (SIDS) dossier and SIDS Initial Assessment Report (SIAR) for LCCP discuss LCCP isoparaffin content in its section on impurities and states that the amount should not be more than 1-2%. This is consistent with CPIA's understanding of the feedstocks used in LCCP manufacture. Only linear chloroalkanes are desired in commercial CP products and any branched chloroalkane (i.e. chlorinated isoparaffin) content is considered an impurity and should be kept to a minimum.

Response: EPA understands that some CPs may contain only linear chloroalkanes, but for these two “branched and linear” PMN submissions that EPA has received, the percent branching is greater than the 1-2% figure mentioned in the CPIA comments and the branching is thus part of the specific chemical name for TSCA Chemical Inventory purposes.

Comment 3: EPA has designated the PMN/SNUR substances as very long chain chlorinated paraffin (vLCCP), with a nominal carbon chain length of C21 to C30. EPA has designated LCCP as C18 to C20 chloroalkanes, although in all other venues, including EPA's previous CP testing program, the OECD SIDS assessment, the European Union (EU) Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) dossier, and other recent assessments, LCCP has been considered as C18 to C30. Most of the recent LCCP assessments have evaluated LCCP as a category comprised of three main subcategories: C18 to C20 Liquid LCCP, C20 to C30 Liquid LCCP, and C20 to C30 Solid LCCP.

Response: EPA recognizes that CPIA does not agree with the EPA designations for LCCP vs. vLCCP. The designation/cut-off for LCCPs and vLCCPs represents the chain lengths potentially contained in the liquid chlorinated paraffins and waxy/solid chlorinated paraffins. These designations (i.e., the differentiation between C18-20 and C20 CPs) are consistent with those in other jurisdictions, e.g., Environment Canada (see Ref. 1). There are a series of interactions that the CP industry has had with EPA over the years, including TSCA section 4 test rules on specific TSCA chemicals and the Toxics Release Inventory (TRI). In previous actions under TSCA and TRI, the Agency has used a different naming convention, often based on public comment from industry. However, in each action the chemical substance that was the subject of the action has been clear because information such as chemical formula has been part of the identification. Previous attempts to divide chlorinated paraffins into various categories were based primarily on industrial usage patterns and industry comment, not on toxicological information.

Regardless of the naming conventions raised by the commenter, in reviewing the studies submitted with the PMNs in this SNUR and other PMNs, and the scientific literature more broadly, EPA has concluded that that there is a continuum of effects linked to chain length and degree of chlorination. On the one end of the spectrum are SCCPs and MCCPs; more data are available on these chain lengths, and EPA has concluded that sufficient data exists to conclude that they may be PBTs. There are also some, albeit significantly less, data on the vLCCPs, most of which appear to point to a lack of effects, but the chemical composition of the test substances was poorly characterized. Ultimately, EPA is interested in specific fate and toxicity tests on vLCCPs that elucidate the relationship between degree of chlorination and alkyl chain length. The testing schema is designed to minimize the burden of testing of complex mixtures with numerous congeners.

Comment 4: According to the commenter, in the United States, commercial LCCP products have generally been in either the C20 to C30 liquid or C20 to C30 solid subcategories, with C18 to C20 liquid LCCP products found mostly in the European market. Given the lack of C18 to C20 liquid LCCP products in the U.S. market, CPIA does not necessarily object to EPA's division of the existing category into LCCP and vLCCP. However, CPIA, believes that drawing a “bright line” at a carbon length of C20 is questionable based on the toxicology and environmental fate data available. CPIA cites as support the conclusion of the OECD SIDS Initial Assessment Profile (SIAP) of LCCP, that “C20-30 liquid and solid LCCPs are of low concern for the environment based on their low hazard profiles. . . . Adequate screening-level data are available to characterize the environmental hazard for the purposes of the OECD HPV (High Production Volume) Chemicals Programme.”

Response: EPA recognizes that CPIA does not agree with the EPA designations for LCCP vs. vLCCP. EPA disagrees with CPIA that linear C18 to C20 CPs are not available within the United States, as EPA has received one or more PMN submissions for these types of CPs and therefore they may be commercially available. Further, these designations are consistent with those in other jurisdictions, e.g., Environment Canada (Ref. 1). Please refer to the response to Comment 1 for the issue of hazard and PBT discussions pertaining to chain length.

Comment 5: Limited information on EPA's assessment of vLCCP is provided in the proposed SNUR, associated Consent Order, and the rulemaking docket. Perhaps this limited information is due to the nature of this SNUR and the PMN review process.

Response: EPA reviewed the PMNs based on the contents of the PMN and information available on analogs and in the literature. As with all PMN submissions, EPA has followed the processes, procedures and statutory provisions of TSCA section 5 for the chlorinated paraffin PMNs, including EPA's Policy Statement on PBT New Chemical Substances (64 FR 60194; November 4, 1999; FRL-6097-7). EPA's assessment of exposures and risks for these three PMN substances is provided in Unit IV of the Preamble to the section 5(e) Consent Order (available in the public docket to the proposed rule) and is also presented in the response to Comment 1. Note that EPA has recently made available assessments for certain MCCP and LCCP PMNs, in the Federal Register of December 23, 2015 (80 FR 79886) (FRL-9940-13).

Comment 6: EPA indicates that it was unable to locate any chronic aquatic toxicity data on LCCP and as a consequence has relied solely on MCCP data. Further, EPA claims that based on these MCCP data there may be concerns regarding vLCCP's aquatic toxicity. EPA should be aware that there are both chronic fish and invertebrate toxicity data on various carbon chain length and chlorination level LCCP test materials. These were included in all of the recent reviews of LCCP, including the OECD SIDS assessment, the REACH registration dossier, and the U.K. LCCP Environmental Risk Assessment report.

Response: As noted in the TSCA section 5(e) Consent Order signed with the PMN submitter and available in the public docket, there were no valid chronic aquatic toxicity data available for LCCPs or vLCCPs. EPA did consider the LCCP REACH Consortium aquatic toxicity database (see Attachment B in the CPIA comments), but the data were inadequate to allow EPA to identify a Concentration of Concern (COC). The studies tested concentrations in excess of the water solubility and did not analytically measure the concentrations that were in solution, which led to results orders of magnitude above the water solubility. Given the lack of reliable test data for the PMN substances listed in the SNUR, EPA used a read-across approach using MCCPs. The chronic aquatic toxicity test results and resulting COCs for MCCP data are within the estimated water solubilities and therefore these data are deemed reliable. The most reliable and acceptable studies indicate that, for vLCCPs, the predicted toxicity to aquatic organisms for acute endpoints are no effects at saturation. For the chronic toxicity endpoint, EPA used the aquatic invertebrate chronic value of 0.013 mg/L from the Thompson et al. 1997 study (Ref. 2) based on a MCCP material. This value was divided by an assessment factor of 10 to yield 0.0013 mg/L or 1.3 micrograms (μg)/L or 1.3 parts per billion (ppb).

Comment 7: CPIA readily acknowledges that, as EPA notes, toxicity to aquatic plant life and toxicity to sediment organisms are data gaps for LCCP. There have been several different approaches used to fill these data gaps. In the case of aquatic plant life, some testing has been done on LCCP toxicity to aquatic plant life though the reliability of these data has been called into question by reviewers and the data were not deemed sufficiently valid to address the endpoint. Most assessments of LCCP have thus considered read-across data from MCCP as being adequate to fill this data gap. The data from MCCP indicate that neither MCCP, nor LCCP by analogy, are toxic to aquatic plant life. Given this, CPIA supports the use of MCCP data in the assessment of LCCP/vLCCP.

Response: EPA agrees that toxicity to aquatic plant life is a data gap for LCCP/vLCCP and that MCCP serves as an appropriate analog in a read-across approach.

Comment 8: For LCCP sediment toxicity and risk, previous assessments by the U.K. Environment Agency and the REACH registration dossier have extrapolated from LCCP aquatic toxicity data to sediment toxicity using the equilibrium partitioning method. This approach is detailed in Attachment C of CPIA's comments, which is a direct excerpt from the U.K. Environment Agency's (EA) LCCP assessment. Given the very low water solubility of LCCP and the very high predicted Kow, this method estimates rather high predicted no effect concentrations (PNECs) for LCCP. A PNEC is functionally similar to EPA's concentration of concern (CoC) in that both are points of departure for environmental risk assessment. The comparison between the sediment PNECs derived by the EA using the equilibrium partitioning method and the sediment CoC derived by EPA using an MCCP sediment toxicity study are orders of magnitude apart. Given this large difference and the fact that both methods have limitations, CPIA thinks that this may be a data gap to consider for additional testing of vLCCP assuming chemical analysis concerns can be addressed and only if exposure/release information actually dictate a need for this testing.

Response: EPA agrees that sediment toxicity is a data gap for vLCCPs. The most reliable and acceptable value for the toxicity to sediment invertebrate organisms is based on the MCCP material from the Thompson et al. 2002 study (Ref. 3). For vLCCPs, EPA used the 28-day sediment invertebrate Geometric Mean Acceptable Toxicant Concentration (GMATC) value of 187 mg/kg dry weight sediment as an analog approach to assess hazard. To calculate an acute concern concentration, this value is first multiplied by an acute to chronic ratio for invertebrates of 10 to yield 1,870 mg/kg dry weight sediment, and then this value is divided by an assessment factor of 5 to yield 374 mg/kg dry weight sediment. For the chronic toxicity endpoint, EPA used the 28-day sediment invertebrate GMATC of 187 mg/kg dry weight sediment also from the Thompson et al. 2002 study. This value is divided by an assessment factor of 10 to yield 18.7 mg/kg dry weight sediment.

Comment 9: EPA states that vLCCP by analogy to MCCP may be “potentially highly persistent, potentially bioaccumulative and potentially toxic.” EPA further indicates that, “[t]ransport and magnification across trophic levels may also result in toxicity to higher organisms, including fish, higher predators, and potentially humans,” though it is not clear whether this statement is directed at vLCCP or MCCP as an analog. Regardless, EPA should be aware there has been considerable research done in recent years on the environmental fate of MCCP, including new research on biodegradation and the potential for bioaccumulation, including trophic magnification potential.

Response: EPA has reviewed all the information cited by CPIA, including the specific biodegradation studies described in the comments and biodegradation studies on LCCPs. No persistence or bioaccumulation data were available or submitted to EPA for the commercial Unknown or Variable composition, Complex reaction products and Biological materials (UVCB) multicomponent substances described in the PMNs. In the absence of data on the commercial UVCB substances, EPA used data on their components, analogs and used a read-across approach. EPA notes that close analogs of MCCPs are the short chain chlorinated paraffins (SCCPs) which have been proposed for addition to the Stockholm Convention on Persistent Organic Pollutants.

Comment 10: Given the available data, CPIA believes that any analogy to MCCP for vLCCP must consider that while lower chlorinated CP substances may have somewhat greater capacity to bioaccumulate—though bioaccumulation will also decrease significantly with increasing carbon chain length—these same lower chlorinated CPs show a greater potential to biodegrade. In fact, MCCP constituents up to 50% chlorination have been found to be readily biodegradable and therefore are not persistent, bioaccumulative, and toxic chemicals (PBTs). Higher chlorinated MCCP constituents also showed significant potential to biodegrade though the results did not reach the “ready” criteria. Perhaps even more telling is the fact that field studies have not shown MCCP to biomagnify across trophic levels (Ref. 4). CPIA believes that vLCCP, which is less soluble in water and less bioavailable than MCCP, will have even less potential to move up through the troposphere and biomagnify. This conclusion was similarly reached by the U.K. Environment Agency (Ref. 5), the OECD (Ref. 6), and the European Chemical Bureau (ECB) PBT Working Group (Ref. 7).

Response: EPA has reviewed all the information cited by CPIA including the specific bioaccumulation/biomagnification studies described in the comments. No persistence or bioaccumulation data were submitted for the commercial UVCB multicomponent substances described in the PMNs. In the absence of data on the commercial UVCB multicomponent substance, EPA used data on components of that substance, structural analogs and a read-across approach. Although bioaccumulation data are lacking with vLCCPs, there is still concern for the presence of lower chain length and moderately chlorinated components in the vLCCP commercial UVCB multicomponent substance that have the potential to be both persistent and bioaccumulative. EPA considered more recent reviews of the bioaccumulation potential of MCCPs by Thompson and Vaughn (Ref. 4) and Arnot (Ref. 8) in making the determination that MCCPs may be very bioaccumulative. The framework for assessing bioaccumulation outlined by Gobas et al. (Ref. 9) describes a preferred data hierarchy that places field Trophic Magnification Factor (TMF) studies at the top. EPA recognizes that there are significant uncertainties associated with the available TMF data for MCCPs. In the absence of such data, the framework outlines the use of bioconcentration factors (BCFs), bioaccumulation factors (BAFs), and biomagnification factors (BMFs) to be considered with caution. EPA believes that its review of available data on the bioaccumulation potential of MCCPs is consistent with the approach described by Gobas et al. (Ref. 9) and that the data support its finding that MCCPs may be very bioaccumulative and by analogy so may vLCCPs.

Comment 11: CPIA is concerned that EPA's proposed testing approach for vLCCP in the proposed SNUR (Attachment A of CPIA's comments) fails to consider the highly complex nature of the LCCP/vLCCP UVCB substances and the analytical limitations inherent to this complex composition. For example, even a single carbon-chain length straight-chain chloroalkane, will have tens of thousands or more possible isomers. Tomy et al. (Ref. 10) calculated that for a C13 chloroalkane at 60% chlorination by weight, the total number of possible isomers is 3,549, even assuming no more than one chlorine atom bound to an individual carbon atom. This number of theoretical isomers more than doubles with each added carbon number, suggesting that by C21, the lowest carbon chain length that EPA has proposed testing, this test material could have hundreds of thousands of possible isomers.

Response: EPA understands the complexity of vLCCPs and therefore stipulates under the consent order for the PMN substances the testing of three specific chain lengths and chlorination levels. EPA expects that a single chain length at a specific chlorination level can be produced. The purpose of the sequence of testing, i.e., biodegradation testing and identification of degradation products followed by bioaccumulation testing and benthic toxicity testing, is to use the results of the biodegradation tests to identify biodegradation products. The selection of three less complex congener PMN surrogates for testing reduces the analytical complexities associated with characterization of the test substance and identification of products formed during biodegradation testing.

Comment 12. Current guidance from manufacturers indicates that vLCCP substances should not be released to surface water and/or poured down the drain. When this guidance is applied to exposure models, the predicted releases levels to surface water and corresponding concentrations in sediment are below the levels of concern.

Response: While the SNUR is not based on EPA's risk assessment, EPA notes that information regarding releases of vLCCPs was submitted to EPA by the PMN submitter of these three SNUR substances and is used in the risk assessment. EPA's risk assessment for the PMN substances indicated that releases of the substances may occur and that without the less than 1 weight percent of chlorinated paraffins with an alkyl chain ≤ 20 manufacturing restriction, those releases may pose an unreasonable risk to the environment. Further, apart from any risk resulting from releases assessed for the PMN chemical substance, chlorinated paraffins with alkyl chain lengths ≤ 20 are very persistent and very bioaccumulative toxic chemical substances. Thus a SNUR is important because it gives EPA an opportunity to review and evaluate data on the significant new use before it commences. These significant new use may have release and exposure profiles that are different from that considered in the PMN.

To the extent that the commenter is suggesting that the predicted releases to surface water do not present a risk and thus do not support a significant new determination, EPA notes that a significant new use determination is not based on risk.

If uses begun after the proposed rule was published were considered ongoing rather than new, any person could defeat the SNUR by initiating the significant new use before the final rule was issued. Therefore EPA has designated the date of publication of the proposed rule as the cutoff date for determining whether the new use is ongoing. Consult the Federal Register notice of April 24, 1990 (55 FR 17376, FRL 3658-5) for a more detailed discussion of the cutoff date for ongoing uses.

Any person who began commercial manufacture or processing of the chemical substances identified in this rule for any of the significant new uses designated in the proposed SNUR after the date of publication of the proposed SNUR, must stop that activity before the effective date of the final rule. Persons who ceased those activities will have to first comply with all applicable SNUR notification requirements and wait until the notice review period, including any extensions, expires, before engaging in any activities designated as significant new uses. If a person were to meet the conditions of advance compliance under 40 CFR 721.45(h), the person would be considered to have met the requirements of the final SNUR for those activities.

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

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

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

In the absence of a TSCA section 4 test rule or a TSCA section 5(b)(4) listing covering the chemical substance, persons are required only to submit test data in their possession or control and to describe any other data known to or reasonably ascertainable by them (see § 720.50). However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing.

Recommended testing that would address the criteria of concern of § 721.170 can be found in Unit IV. of the proposed rule. Descriptions of tests are provided only for informational purposes. EPA strongly encourages persons, before performing any testing, to consult with the Agency pertaining to protocol selection.

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

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

• Potential benefits of the chemical substances.

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

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

EPA evaluated the potential costs of SNUN requirements for potential manufacturers and processors of the chemical substances in the rule. The Agency's complete Economic Analysis is available in the docket under docket ID number EPA-HQ-OPPT-2014-0390

The following is a listing of those documents used to prepare the preamble to this final rule. Additional information for this final rule can be located under docket ID number EPA-HQ-OPPT-2013-0399, which is available for inspection as specified under ADDRESSES.

This final rule establishes SNURs for chemical substances that were the subject of PMNs. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993).

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

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

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

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

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

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

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

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

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

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

Therefore, the promulgation of the SNUR would not have a significant economic impact on a substantial number of small entities.

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

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

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

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

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

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

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

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

On October 5, 2015 (80 FR 60110), EPA published a notice of proposed rulemaking (NPR) for the State of West Virginia. In the NPR, EPA proposed approval of a revision to the West Virginia Title V Operating Permit Program. The formal program revision was submitted by the State of West Virginia on June 17, 2015.

In the June 17, 2015 program revision submittal, West Virginia included revisions to 45CSR30.8 to increase West Virginia's annual emission fees for its Title V Operating Permit Program. West Virginia increased the annual fees to $28 per ton of emissions of a regulated pollutant from an individual source subject to the West Virginia Title V Operating Permit Program. The previous rate in 45CSR30.8 was $18 per ton of regulated pollutant. This revised fee per ton became effective on May 1, 2015 and replaced the prior fee, $18 per ton, which was effective July 1, 1995 through April 30, 2015.1 As discussed in the NPR, without this fee increase, West Virginia anticipated that funds would not be sufficient to sustain its Title V Operating Permit Program in a manner consistent with state and federal requirements. In the NPR, the EPA proposed to approve the revision increasing annual Title V fees that the owners or operators of Title V facilities in West Virginia must pay pursuant to 45CSR30.8. The EPA explained that the revision met requirements in section 502 of the CAA and 40 CFR 70.9 for the collection of sufficient Title V fees to cover permit program implementation and oversight costs. The emission fees apply to emissions up to 4,000 tons of any regulated pollutant. However, the EPA's NPR inadvertently misstated that the revision to 45CSR30.8 would increase fees to $25 per ton of regulated pollutant, rather than the correct figure of $28 per ton of regulated pollutant. This error in the NPR by the EPA was inadvertent and does not affect the rationale for the EPA's proposed approval of the Title V permit fee increase as the EPA's evaluation for the NPR was based on 45CSR30.8 which provided for the increase to $28 per ton of regulated pollutant emitted.2

Other specific requirements of the program revision and the rationale for the EPA's proposed action are explained in the NPR and will not be restated here.

Comment: The EPA received one comment during the public comment period on the proposed approval of the revision to West Virginia's Title V Operating Permit Program. The comment was submitted on behalf of the West Virginia Department of Environmental Protection (WVDEP). In the comment letter, the WVDEP noted that the new fee provisions contained in the revision to 45CSR30 as part of WVDEP's June 17, 2015 submission to EPA was $28 per ton of regulated pollutants as emitted by individual sources subject to the West Virginia Title V Operating Permit Program. The WVDEP noted that the EPA's NPR incorrectly stated the new fee per ton of regulated pollutant emitted was $25 instead of $28 per ton emitted.3

Response: The EPA appreciates WVDEP's comment and acknowledges it inadvertently stated in the NPR that the annual fee per ton of regulated pollutant emitted for an individual source subject to the West Virginia Title V Operating Permit Program was increased to $25 per ton of regulated pollutant emitted. WVDEP correctly noted in its comments that 45CSR30.8 increased the fee for emissions to $28 per ton of regulated pollutant emitted from a Title V source. This increase from $18 per ton to $28 per ton of regulated pollutant emitted was effective on May 1, 2015. WVDEP's June 17, 2015 submittal of the revised 45CSR30.8 to the EPA correctly indicated the new fee per ton of regulated pollutant emitted was $28. EPA evaluated the Title V program revision after reviewing 45CSR30.8 and evaluating the permit fee increase at $28 per ton emitted. The EPA's error in the NPR in incorrectly referring to new fees of $25 per ton emitted was inadvertent and did not affect our analysis or proposed conclusion that the permit fee revision met requirements in the CAA for Title V permit programs.

The WVDEP comment letter corrects the EPA's error and clarifies that the correct fee per ton of regulated pollutant emitted by a Title V permitted source is $28 per ton. As noted previously, the revision to 45CSR30.8 increasing the permit fee from $18 per ton to $28 per ton of regulated pollutant emitted meets requirements in section 502 of the CAA and 40 CFR 70.9 for the collection of sufficient Title V fees to cover permit program implementation and oversight costs. The EPA's determination that West Virginia's Title V Operating Permit Program continues to meet obligations to collect sufficient fees to implement its Title V program is not altered by our inadvertent reference to $25 per ton of regulated pollutant emitted instead of $28 per ton emitted as our analysis was based on the revised 45CSR30.8 which listed the correct fee as $28 per ton.

The EPA also finds no further comment period is needed to address the inadvertent reference to the per ton fee increase. The EPA's finding that the revised fees in 45CSR30.8 meet requirements in section 502 of the CAA and 40 CFR 70.9 was explained in the NPR, and the specific finding that the $28 per ton meets requirements for Title V permit fees to fund a Title V program is a logical outgrowth of the proposed rule. No additional notice or opportunity to comment is necessary where, as here, the final rule is “in character with the original scheme,” and does not “substantially depart [] from the terms or substance” of the proposal. Chocolate Mfrs. Ass'n v. Block, 755 F.2d 1098 (4th Cir. 1985). “[A] final rule will be deemed to be the logical outgrowth of a proposed rule if a new round of notice and comment would not provide commentators with their first occasion to offer new and different criticisms which the agency might find convincing.” Fertilizer Inst. v. EPA, 935 F.2d 1303, 1311 (D.C. Cir. 1991) (citation and internal quotation marks omitted).

Notwithstanding the NPR's erroneous description of the revised fee being $25 per ton of regulated pollutant, the EPA's determination about the sufficiency of this fee was in fact based on our evaluation of the slightly larger $28-per-ton fee. The NPR also cited the correct provision of West Virginia law, which also would have confirmed to potential commenters that the state's proposed fee increase was to $28 per ton. The docket similarly included information clarifying that the proposed revision would increase certain fees to $28 per ton of regulated pollutants.4

Accordingly, a supplemental notice clarifying the per-ton fee would not provide any commentators with a first occasion to offer any new or different criticisms of WVDEP's Title V permit fees. Nor would any such criticism convince EPA to alter our conclusion. As stated in the NPR, WVDEP found its permit fee of $18 per ton was insufficient to allow adequate implementation of its Title V Operating Permit Program. After internal analysis, WVDEP concluded it needed the additional revenue from permit fees at $28 per ton emitted to fund sufficiently its Title V Operating Permit Program, and EPA concurs with that conclusion. Further opportunity for comment would not provide any opportunity for criticism of West Virginia's new permit fee which the EPA would find convincing. Thus, our approval of West Virginia's Title V Operating Permits Program including the revision to 45CSR30.8 is final as a “logical outgrowth” of the proposed approval announced in the NPR.

EPA is approving the June 17, 2015 Title V Operating Permit Program revision submitted by the State of West Virginia to increase Title V permit fees paid by owners or operators of Title V sources in West Virginia from $18 per ton of regulated pollutant emitted to $28 per ton of regulated pollutant emitted. The revision meets requirements in section 503 of the CAA and of 40 CFR 70.9.

This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. For that reason, this action:

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

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

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

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

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

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

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

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

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

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by April 12, 2016. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action which approves the June 17, 2015 program revision submittal by the State of West Virginia as a revision to the West Virginia Title V Operating Permits Program may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

Under the CSAPR FIPs, a portion of each state budget for each of the four CSAPR trading programs is reserved as a NUSA from which allowances are allocated to eligible units through an annual one- or two-round process. EPA has described the CSAPR NUSA allocation process in five NODAs previously published in the Federal Register (80 FR 30988, June 1, 2015; 80 FR 44882, July 28, 2015; 80 FR 55061, September 14, 2015; 80 FR 69883, November 12, 2015; 80 FR 77591, December 15, 2015). In the most recent of these previous NODAs, EPA provided notice of preliminary lists of new units eligible for second-round 2015 NUSA allocations of CSAPR NOX Annual, SO2 Group 1, and SO2 Group 2 allowances and provided an opportunity for the public to submit objections.

EPA received no objections to the preliminary lists of new units eligible for second-round 2015 NUSA allocations of CSAPR NOX Annual, SO2 Group 1, or SO2 Group 2 allowances whose availability was announced in the December 15 NODA. EPA is therefore making second-round 2015 NUSA allocations of CSAPR NOX Annual, SO2 Group 1, and SO2 Group 2 allowances to the new units identified on these lists in accordance with the procedures set forth in 40 CFR 97.412(a)(9) and (12), 97.612(a)(9) and (12), and 97.712(a)(9) and (12).

As described in the December 15 NODA, any allowances remaining in the CSAPR NOX Annual, SO2 Group 1, and SO2 Group 2 NUSAs for a given state and control period after the second round of NUSA allocations to new units is completed are to be allocated to the existing units in the state according to the procedures set forth in 40 CFR 97.412(a)(10) and (12), 97.612(a)(10) and (12), and 97.712(a)(10) and (12). EPA has determined that CSAPR NOX Annual, SO2 Group 1, and SO2 Group 2 allowances do remain in the NUSAs for a number of states following completion of second-round 2015 NUSA allocations; accordingly, EPA is allocating these allowances to existing units. The NUSA allowances are generally allocated to the existing units in proportion to the allocations previously made to the existing units under 40 CFR 97.411(a)(1), 97.611(a)(1), and 97.711(a)(1), adjusted for rounding.

Under 40 CFR 97.412(b)(10), 97.612(b)(10), and 97.712(b)(10), any allowances remaining in the CSAPR NOX Annual, SO2 Group 1, and SO2 Group 2 Indian country NUSAs for a given state and control period after the second round of Indian country NUSA allocations to new units are added to the NUSA for that state or are made available for allocation by the state pursuant to an approved SIP revision. No new units eligible for allocations of CSAPR NOX Annual, SO2 Group 1, and SO2 Group 2 allowances from any 2015 Indian country NUSA have been identified, and no state has an approved SIP revision governing allocation of 2015 CSAPR allowances. The Indian country NUSA allowances are therefore being added to the NUSAs for the respective states and are included in the pools of allowances that are being allocated to existing units under 40 CFR 97.412(b)(10) and (12), 97.612(b)(10) and (12), and 97.712(b)(10) and (12).

The final unit-by-unit data and allowance allocation calculations are set forth in Excel spreadsheets titled “CSAPR_NUSA_2015_NOx_Annual_2nd_Round_Final_Data_New_Units”, “CSAPR_NUSA_2015_SO2_2nd_Round_Final_Data_New_Units”, “CSAPR_NUSA_2015_NOx_Annual_2nd_Round_Final_Data_Existing_Units”, and “CSAPR_NUSA_2015_SO2_2nd_Round_Final_Data_Existing_Units”, available on EPA's Web site at http://www.epa.gov/crossstaterule/actions.html.

Pursuant to CSAPR's allowance recordation timing requirements, the allocated NUSA allowances will be recorded in sources' AMS accounts by February 15, 2016. EPA notes that an allocation or lack of allocation of allowances to a given unit does not constitute a determination that CSAPR does or does not apply to the unit. EPA also notes that NUSA allocations of CSAPR NOX Annual, SO2 Group 1, and SO2 Group 2 allowances are subject to potential correction if a unit to which NUSA allowances have been allocated for a given compliance year is not actually an affected unit as of January 1 of the compliance year.1

(Authority: 40 CFR 97.411(b), 97.611(b), and 97.711(b).)

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-2014-0672 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 April 12, 2016. 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-2014-0672, by one of the following methods:

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

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

• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

In the Federal Register of February 11, 2015 (80 FR 7559) (FRL-9921-94), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 4E8306) by IR-4, IR-4 Project Headquarters, Rutgers, The State University of New Jersey, 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40 CFR 180.377 be amended by: (1) Establishing tolerances in for the combined residues of the insecticide diflubenzuron N-[[(4-chlorophenyl)amino]carbonyl]-2,6-difluorobenzamide) and its metabolites 4-chlorophenlyurea and 4-chloroaniline, in or on the raw agricultural commodities carrot, roots at 0.2 ppm; peach subgroup 12-12B at 0.5 ppm; plum subgroup 12-12C at 0.5 ppm; plum, prune, dried at 0.5 ppm; nut, tree group 14-12 at 0.2 ppm; pepper/eggplant subgroup 8-10 B at 1.0 ppm, and cottonseed subgroup 20C at 0.2 ppm; (2) upon the approval of these tolerances, removing established tolerances in or on fruit, stone, group 12, except cherry at 0.07 ppm; nut, tree, group 14 at 0.06 ppm; pistachio at 0.06 ppm; pepper at 1.0 ppm; and cotton, undelinted seed at 0.2 ppm; (3) establishing regional tolerances for the combined residues of diflubenzuron and its metabolites 4-chlorophenlyurea and 4-chloroaniline in or on the raw agricultural commodities alfalfa, forage at 6 ppm; alfalfa, hay at 20 ppm; and alfalfa, seed at 0.9 ppm; and (4) modifying the existing tolerances in or on the following raw agricultural commodities: Egg from 0.05 to 0.15 ppm; poultry, fat from 0.05 to 0.15 ppm; and poultry, meat byproducts from 0.05 to 0.06 ppm. That document referenced a summary of the petition prepared by Chemtura Corporation, the registrant, which is available in the docket, http://www.regulations.gov. A second notice of filing for the same petition (PP 4E8306) and same uses was inadvertently published in the Federal Register on December 2, 2015 (80 FR 75449) (FRL-9939-55). This notice of filing contained the same information as the previously published notice of filing. Comments were received in response to both notices of filing. EPA's response to these comments is discussed in Unit IV.C.

Based upon review of the data supporting the petition, EPA has modified the levels at which some of the tolerances are being established. The reason 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 diflubenzuron including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with diflubenzuron 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.

For diflubenzuron, the hemopoietic system is the target site with effects including increased sulfhemoglobin and/or methemoglobin levels in rat and dog studies. In subchronic and chronic feeding studies, the primary endpoint of concern was methemoglobinemia and/or sulfhemoglobinemia. These effects were evident in both sexes of mice, rats, and dogs and were produced by more than one route of administration in rats (i.e., oral, dermal and inhalation). The general consequence of methemoglobinemia and/or sulfhemoglobinemia is the impairment of the oxygen transportation capacity of the blood, which is generally known to be caused by aromatic amines in both humans and animals. Degradates of diflubenzuron with aromatic amines, CPU (4-chlorophenylurea) and PCA (4-chloroaniline), are also included in the diflubenzuron non-cancer risk assessment. Monuron, an analog of CPU, does not affect methemoglobin formation but does produce tumors in the liver and kidneys of male rats. The non-cancer toxicities of CPU and PCA are understood. PCA is similar in potency to diflubenzuron on methemoglobin formation, while CPU is less toxic than PCA. Therefore, the non-cancer assessment will include diflubenzuron, CPU and PCA, and additional toxicity studies are not required on CPU and PCA.

The toxicity data provide no indication of an increased susceptibility to rats or to rabbits from in utero or postnatal exposure to diflubenzuron. Developmental and reproduction studies in rats and rabbits indicate a very low hazard potential for adverse effects. Developmental studies were tested at the limit dose of 1,000 milligrams/kilogram/day (mg/kg/day) without apparent effects in both dams and the fetuses. The reproduction study indicated that effects in offspring occurred at doses that were higher than the doses producing effects in parents. The requirements for acute and subchronic neurotoxicity studies were waived because there are no clear signs of neurotoxicity following subchronic or chronic dosing in multiple species in the diflubenzuron database. The toxicity profile of diflubenzuron shows that the principal toxic effects are the formation of methemoglobinemia and/or sulfhemoglobinemia in the blood. An immunotoxicity study has been reviewed and immunotoxicity was not observed above the limit dose.

The Agency concluded that diflubenzuron is not carcinogenic in humans based on lack of evidence of carcinogenicity in rats and mice. PCA, a plant metabolite of diflubenzuron, tested positive for splenic tumors in male rats and hepatocellular adenomas/carcinomas in male mice in a National Toxicology Program (NTP) study.

Therefore, EPA has classified PCA as a probable human carcinogen. CPU is the major degradate found in water and is a significant metabolite in milk. CPU is structurally related to monuron (N,Ndimethyl-CPU), a compound producing tumors of the kidney and liver in male rats. EPA has assumed CPU is a probable human carcinogen as well. However, based on methemoglobinemia observed only at high doses of monuron, a compound similar to CPU and PCA, the non-carcinogenic risk assessment will include diflubenzuron, CPU, and PCA.

Specific information on the studies received and the nature of the adverse effects caused by diflubenzuron as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document titled “Diflubenzuron: Human Health Risk Assessment for an Amended Section 3 Registration for Carrot, Peach Subgroup 12-12B, Plum Subgroup 12-12C, Pepper/Eggplant Subgroup 8-10B, Cottonseed Subgroup 20C, Alfalfa (Regional Restrictions) and R175 Crop Group Conversion for Tree Nut Group 14-12” on page 45 in docket ID number EPA-HQ-OPP-2014-0672.

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

A summary of the toxicological endpoints for diflubenzuron used for human risk assessment is discussed in Table 1 in Unit III.B. of the final rule published in the Federal Register of January 31, 2014 (79 FR 5294) (FRL-9904-27).

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to diflubenzuron, EPA considered exposure under the petitioned-for tolerances as well as all existing diflubenzuron tolerances in 40 CFR 180.377. EPA assessed dietary exposures from diflubenzuron 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. No such effects were identified in the toxicological studies for diflubenzuron; therefore, a quantitative acute dietary exposure assessment is unnecessary.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the United States Department of Agriculture (USDA) National Health and Nutrition Examination Survey, “What We Eat in America” (NHANES/WWEIA) from 2003 through 2008. As to residue levels in food, EPA used the assumption that diflubenzuron residues are present in most commodities at tolerance levels (including tolerances previously established as well as those established in this action) and that 100% of all crops are treated. Average field trial residues were assumed for grapefruit, lemon, and orange. Tolerances include residues of diflubenzuron, PCA, and CPU.

iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that diflubenzuron does not pose a cancer risk to humans. However, the metabolites CPU and PCA are considered probable carcinogens and have Q*s assigned to them. Individual cancer dietary exposure analyses were conducted for each metabolite. For PCA, average percent crop treated (PCT) was used for some commodities. One-half the Limit of Quantitation (LOQ) was used for estimating PCA residues on the majority of crops because most crops did not contain detectable residues of PCA. Average field trial residue was used for mushrooms. The CPU cancer dietary analysis focused on CPU residues in milk because metabolism studies indicate that diflubenzuron metabolizes to CPU in milk. EPA assumed that 100% of milk commodities contained CPU at 1/2 the LOQ. One-half the LOQ was used since detectable residues of CPU were not found in the feeding study.

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

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

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

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

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

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

For the cancer dietary exposure analysis, the Agency estimated the PCT for existing uses as follows:

Soybeans (1%), peppers (2.5%), oranges (10%), tangerines (10%), grapefruit (25%), pear (5%), apricot (10%), peach (5%), almond, (10%), pecan (2.5%), rice (2.5%), wheat (1%), cotton (1%), artichoke (45%), peanut (10%), lemon (1%), plum (5%), and walnut (2.5%).

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

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

2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for diflubenzuron and CPU in drinking water. PCA is only a minor metabolite in the environment and residues are not expected to be present in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of diflubenzuron. 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.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model.

Based on the Surface Water Concentration Calculator model (SWCC) for surface water the Estimated Drinking Water Concentration (EDWC) of 1.3 microgram/Liter (μg/L) (including diflubenzuron and CPU) was used to assess chronic non-cancer dietary risk. Based on the Pesticide Root Zone Model-Groundwater (PRZM-GW) model for ground water the cancer risk for CPU was assessed using the EDWC of 8.02 μg/L.

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).

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

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

2. Prenatal and postnatal sensitivity. Based on the available developmental toxicity studies in rats and rabbits and the reproduction study, there is no increased susceptibility to fetuses exposed in utero. There was no indication of abnormalities in fetal development in the developmental toxicity studies in either rats or rabbits at the maternal limit doses of 1,000 mg/kg/day. In addition, there was no evidence of sensitivity following pre- and/or post-natal exposure in a two-generation reproduction study in rats.

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

i. The toxicological database for diflubenzuron is adequate for risk assessment. The non-cancer toxicity of CPU and PCA is well understood. CPU is less toxic and does not affect methemoglobin. PCA does cause methemoglobin formation but is similar in potency to diflubenzuron. Therefore, assuming equal toxicity of CPU and PCA to diflubenzuron is health protective, additional toxicity studies are not required on the metabolites.

ii. There are no clear signs of neurotoxicity following subchronic or chronic dosing in multiple species in the diflubenzuron database; therefore, there is no need for any neurotoxicity studies.

iii. There is no evidence that diflubenzuron 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. The dietary exposure assessment uses conservative assumptions which will not underestimate dietary exposure and EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to diflubenzuron in drinking water. These assessments will not underestimate the exposure and risks posed by diflubenzuron.

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

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to diflubenzuron from food and water will utilize 39% of the cPAD for children 1 to 2 years old, the population group receiving the greatest exposure. There are no residential uses for diflubenzuron.

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

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

4. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, diflubenzuron is not expected to pose a cancer risk to humans. However, the metabolites CPU and PCA are considered probable carcinogens and have Q*s assigned to them. Individual cancer dietary exposure analyses were conducted for each metabolite. The cancer assessment for PCA includes food only (it is not expected to be present in drinking water). The cancer assessment for CPU includes milk and water only. For PCA, the cancer dietary exposure estimate for the U.S. population is 1.3 × 10−6. For CPU, the cancer dietary exposure estimate for the U.S. population is 2.8 × 10−6.

EPA generally considers cancer risks in the range of 10−6 or less to be negligible. The precision which can be assumed for cancer risk estimates is best described by rounding to the nearest integral order of magnitude on the log scale; for example, risks falling between 3 × 10−7 and 3 × 10−6 are expressed as risks in the range of 10−6.

Considering the precision with which cancer hazard can be estimated, the conservativeness of low-dose linear extrapolation, and the rounding procedure described above, cancer risk should generally not be assumed to exceed the benchmark level of concern of the range of 10−6 until the calculated risk exceeds approximately 3 × 10−6. This is particularly the case where some conservatism is maintained in the exposure assessment. Although the PCA and CPU exposure risk assessment are refined, they retain significant conservatism in that residues in food were estimated at 1/2 LOQ even though no residues were detected in field trials and feeding studies, and for some commodities EPA assumed 100 PCT. Accordingly, EPA has concluded the cancer risk for all existing diflubenzuron uses, and the uses associated with the tolerances established in this action fall within the range of 1 × 10−6 and are thus negligible.

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 diflubenzuron residues.

Adequate enforcement analytical methods are available for the enforcement of tolerances for residues of diflubenzuron and its metabolites in crop and livestock commodities. Three enforcement methods for diflubenzuron are published in PAM, Vol. II as Methods I, II, and III. Method I is a GC/ECD method that determines diflubenzuron in plants as derivatized 4-chloroaniline (PCA). Method II is a GC/ECD method that can separately determine residues of diflubenzuron, 4-chlorophenylurea (CPU) and PCA in eggs, milk, and livestock tissues, each as derivatized PCA. Method III is an HPLC/UV method that determines diflubenzuron per se in eggs, milk, and livestock tissues. All three methods have undergone successful Agency validations.

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 established MRLs for diflubenzuron in or on peach and nectarine at 0.5 ppm which is the same as the tolerance in the United States for the peach subgroup 12-12B at 0.50 ppm; a tolerance on plums at 0.5 ppm which is the same as the U.S. tolerance for the plum subgroup 12-12C at 0.5 ppm; and a tolerance on tree nuts at 0.2 ppm which is the same as the U.S. tolerance for the tree nut group 14-12 at 0.20 ppm, and which was raised to harmonize with Codex.

The Codex has established MRLs for diflubenzuron on chili peppers at 3 ppm, dried chili peppers at 20 ppm, and sweet peppers at 0.7 ppm which are different from the tolerances established in the U.S. for diflubenzuron on the pepper/eggplant subgroup 8-10B at 1.0 ppm. The pepper/eggplant subgroup 8-10B covers both bell and non-bell peppers and the Codex MRLs split them out into two separate tolerances which the U.S. does not do because the petition was for the entire subgroup. Based on the residue data submitted and reviewed for this action, it would not be appropriate for the U.S. tolerance to harmonize with either the chili pepper MRL of 3 ppm or the sweet pepper MRL of 0.7 ppm. Also, in regards to the dried chili pepper MRL, this is not expected to be an issue since the U.S. does not set tolerances on dried fruits and vegetables, but instead the processed food is considered to be the whole processed commodity after compensating for or reconstituting the commodity's normal moisture content.

One comment was received in response to the February 11, 2015 Notice of Filing, however, it related to a different chemical than diflubenzuron and therefore is not relevant to this action. Two comments were received in response to the December 2, 2015 Notice of Filing. One commenter opposed residues of this pesticide on food and argued that EPA should deny the petition. The Agency understands the commenter's concerns and recognizes that some individuals believe that pesticides should be banned on agricultural crops. However, the existing legal framework provided by section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA) states that tolerances may be set when persons seeking such tolerances or exemptions have demonstrated that the pesticide meets the safety standard imposed by that statute. This citizen's comment appears to be directed at the underlying statute and not EPA's implementation of it; the citizen has made no contention that EPA has acted in violation of the statutory framework. The second comment stated that “without long term studies of its effects on the environment and the toxic effects on aquatic invertebrates, then there should be a slight reduction in ppm of diflubenzuron used on crops.” This comment is not relevant to the Agency's evaluation of safety of the diflubenzuron tolerances; section 408 of the FFDCA focuses on potential harms to human health and does not permit consideration of effects on the environment.

Based on an evaluation of the residue data, the Agency modified the levels at which tolerances were proposed for the existing tolerances for egg, poultry fat, and poultry meat byproducts. In addition, the Agency determined that a separate tolerance is not required for the commodity “plum, prune, dried” since residues are not found to concentrate on prunes. Lastly, some of the tolerances levels were modified to reflect the correct significant figures.

Therefore, tolerances are established, modified and removed for residues of diflubenzuron N-[[(4-chlorophenyl)amino]carbonyl]-2,6-difluorobenzamide) and its metabolites 4-chlorophenlyurea and 4-chloroaniline, as follows:

Under 180.377(a)(1) a tolerance is established for the cottonseed subgroup 20C at 0.20 ppm; existing tolerances are changed for egg to 0.07 ppm; poultry, fat to 0.10 ppm; and poultry, meat byproducts to 0.08 ppm; and the existing tolerance for cotton, undelinted seed at 0.2 ppm is removed as unnecessary.

Under 180.377(a)(2), tolerances are established in or on the raw agricultural commodities carrot, roots at 0.20 ppm; peach subgroup 12-12B at 0.50 ppm; plum subgroup 12-12C at 0.50 ppm; nut, tree group 14-12 at 0.20 ppm; the pepper/eggplant subgroup 8-10 B at 1.0 ppm; and the following existing tolerances are removed as unnecessary: Fruit, stone, group 12, except cherry at 0.07 ppm; nut, tree, group 14 at 0.06 ppm; pistachio at 0.06 ppm; and pepper at 1.0 ppm.

Under 180.377(c) regional tolerances are established for the combined residues of diflubenzuron and its metabolites 4-chlorophenlyurea and 4-chloroaniline in or on the raw agricultural commodities alfalfa, forage at 6 ppm; alfalfa, hay at 20 ppm; and alfalfa, seed at 0.9 ppm.

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

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

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

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

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

Therefore, 40 CFR chapter I is amended as follows:

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

Under FFDCA section 408(g), 21 U.S.C. 346a, 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-2014-0783 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 April 12, 2016. 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-2014-0783, 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 Wednesday, March 4, 2015 (80 FR 11611) (FRL-9922-68), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition ((PP) IN-10748) by Technology Sciences Group (TSG) 1150 18th Street NW., Suite 1000, Washington, DC 20036, on behalf of the Huntsman Corporation, 8600 Gosling Road, The Woodlands, TX 77381. The petition requested that 40 CFR 180.920 be amended by establishing an exemption from the requirement of a tolerance for residues of benzyl acetate (CAS Reg. No. 140-11-4) when used as an inert ingredient (solvent) in pesticide formulations applied to growing crops only. That document referenced a summary of the petition prepared by the Huntsman Corporation, the petitioner, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

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

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

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

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

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

Benzyl acetate exhibits low levels of toxicity via the dermal route of exposure in rabbits and inhalation and oral routes of exposure in rats. It is mildly irritating to the skin and minimally irritating to the eyes in rabbits. It is not a skin sensitizer in guinea pigs.

In a 13-week feeding study in the rat, atrophic seminiferous tubules were observed in male rats at dose levels of 12,500 parts per millions (ppm) (equivalent to 900 milligrams/kilogram/day (mg/kg/day)). The NOAEL was identified as 6,250 ppm (460 mg/kg/day). In mice, following 13 weeks of exposure via the diet, decreased body weight and food consumption were observed at all doses. The LOAEL was 3,130 ppm (425 mg/kg/day). A NOAEL was not established.

In a developmental toxicity study in the rat, maternal and fetal toxicity were observed at 1,000 mg/kg/day. Maternal toxicity was manifested as decreased body weight and fetal toxicity was manifested as reduced body weights, increased incidence of dilation of the renal pelvis and skeletal variations. Although qualitative fetal susceptibility is observed, fetal effects occur in the presence of maternal toxicity and a clear NOAEL of 500 mg/kg/day was established for maternal and developmental toxicity.

The potential for benzyl acetate to be genotoxic was evaluated in a battery of in vivo mammalian genotoxicity studies. It was negative in the Ames assay (with and without metabolic activation), sister chromatid exchange assay, Chinese hamster ovary cell assay, mouse micronucleus assay and in the dominant lethal assay in Drosophila. However, it gave a positive response in the mouse lymphoma assay. Since other chromosomal aberrations assays as well as gene mutation assays and a dominant lethal assay gave a negative response, it is concluded that benzyl acetate is unlikely to be mutagenic.

Evidence of neurotoxicity and neuronal degeneration was identified in the 13-week studies in rats and mice. Signs of neurotoxicity included tremors and ataxia that were associated with the degeneration of the glial cells in the cerebellum and hippocampus at the doses ≥12,500 ppm (≥2,000 mg/kg/day). Since these effects were induced at doses above the limit dose (1,000 mg/kg/day) and the established cRfD of 1.10 mg/kg/day, will be protective of these effects, the concern is low for these effects.

There is evidence that benzyl acetate suppresses immune function in mammalian systems in the rat however this effect occurs only at a dose that is lethal and well above the limit dose. In the 13-week feeding study in the rat, a decrease in the cellular components of the bone marrow, thymus and lymphoid follicles was observed at 50,000 ppm (3,900 mg/kg/day for males and 4,500 mg/kg/day for females), the highest dose tested and well above the limit dose. The NOAEL for this study was 12,500 ppm (900 mg/kg/day). The potential for immunotoxicity is not of concern because the effects occur well above the limit dose and the exposure to benzyl acetate through the proposed use is unlikely to occur at such a high dose.

The carcinogenicity of benzyl acetate in F344/N rats, and B6C3F1 mice using was evaluated using the gavage method of administration and corn oil as a vehicle. There were indications that benzyl acetate increased the incidences of pancreatic acinar cell adenomas in male rats and the incidences of hepatocellular adenomas and forestomach neoplasms in male and female mice. Because of the confounding effects of corn oil on the incidences of pancreatic neoplasm and because of the controversy over the use of the gavage route of administration, the National Toxicology Program (NTP) decided to re-study benzyl acetate using the dosed feed route of administration. In 1993, the NTP conducted a second set of carcinogenicity studies in rats and mice using the dose feed route of administration. Benzyl acetate was administered via the diet to rats and mice at doses up to 12,000 ppm (510/575 mg/kg/day, male/female). Toxicity was not observed in rats at any dose. In mice, males and females exhibited reduced body weight throughout the entire study at 345/375 mg/kg/day. There was no evidence of carcinogenicity in mice and rats. Since the exposure to benzyl acetate is likely to occur via the dietary route in humans and there is some uncertainty about the use of corn oil in the gavage study, it is concluded that benzyl acetate is unlikely to be carcinogenic to humans via the dietary route of exposure.

In metabolism studies approximately 90% of benzyl acetate is excreted as metabolites primarily in the urine after oral or percutaneous administration. None was detected in the adipose tissue, blood, kidney, liver, lung, muscle, skin or stomach. The major metabolite in the urine was hippuric acid and 95 to 99% of the excreted dose was in this form. Less than 4% remained in the carcass.

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

The point of departure for benzyl acetate is 110 mg/kg/day from the NTP 2-year carcinogenicity study in mice (dietary study) based on decreased in body weights in both sexes at the LOAEL of 345/375 mg/kg/day. There was no NOAEL observed in a 90-day toxicity study in mice based on the effects on body weights seen at all doses (lowest dose tested was 3,130 ppm; equal to 425 mg/kg/day); however, in a carcinogenicity study in mice no effects on body weight were seen at 110 mg/kg/day, therefore, the NOAEL for the carcinogenicity study would be protective of decreased body weights seen in a 90-day study in mice. Therefore, 90-day toxicity study in mice was not selected. This endpoint was used for all exposure scenarios. The dermal absorption and inhalation factors were 100%. The Agency applied an interspecies uncertainty factor (10X) and an intraspecies uncertainty factor (10X); the FQPA safety factor was reduced to 1X.

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

An acute dietary risk assessment was not conducted because no endpoint of concern following a single exposure was identified in the available studies. A chronic dietary exposure assessment was completed and performed using the Dietary Exposure Evaluation Model DEEM-FCIDTM, Version 3.16, which includes food consumption information from the U.S. Department of Agriculture's National Health and Nutrition Examination Survey, “What We Eat In America”, (NHANES/WWEIA). This dietary survey was conducted from 2003 to 2008. In the absence of actual residue data, the inert ingredient evaluation is based on a highly conservative model that assumes that the residue level of the inert ingredient would be no higher than the highest established tolerance for an active ingredient on a given commodity. Implicit in this assumption is that there would be similar rates of degradation between the active and inert ingredient (if any) and that the concentration of inert ingredient in the scenarios leading to these highest of tolerances would be no higher than the concentration of the active ingredient. The model assumes 100 percent crop treated (PCT) for all crops and that every food eaten by a person each day has tolerance-level residues. A complete description of the general approach taken to assess inert ingredient risks in the absence of residue data is contained in the memorandum entitled “Alkyl Amines Polyalkoxylates (Cluster 4): Acute and Chronic Aggregate (Food and Drinking Water) Dietary Exposure and Risk Assessments for the Inerts” (D361707, S. Piper, 2/25/09) and can be found at http://www.regulations.gov in docket ID number EPA-HQ-OPP-2008-0738. Nonpesticidal dietary exposure to benzyl acetate (e.g., use as a food additive (flavoring agent) were also considered as part of aggregate chronic dietary risk assessment.

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

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

Based upon the requested use of benzyl acetate, the Agency does not expect non-occupational, non-dietary exposures. However, there is a potential for residential exposure via non-pesticidal uses such as use in cosmetics and other, pesticide uses, once it is approved. The residential exposure could occur via ingestion products containing benzyl acetate, and via dermal and inhalation routes of exposure through use of products containing benzyl acetate in residential settings. These residential pesticide exposures are considered short-term and intermediate-term in nature. Residential exposures to benzyl acetate as the result of its use as a cosmetic ingredient may be short-, intermediate- or long-term in nature. The aggregate-short term exposure assessment for benzyl acetate considers exposures from the pesticidal and nonpesticidal uses (i.e., flavoring agent and cosmetic ingredient) and would be protective of any potential long-term exposure to benzyl acetate resulting from its use in cosmetics as the same toxicological point of departure is used for all exposure durations and the average daily exposure estimates for cosmetic use is conservatively applied to all exposure durations.

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

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

2. Prenatal and postnatal sensitivity Qualitative fetal susceptibility was observed in the developmental study in rats. Maternal (decrease in body weight) and fetal (reduced body weights, increased incidence of dilation of the renal pelvis and skeletal variations) toxicity were observed at 1,000 mg/kg/day, the limit dose. Since fetal toxicity occurs in the presence of maternal toxicity and a clear NOAEL of 500 mg/kg/day was established, the established cRfD (1.10 mg/kg/day) will be protective of these effects. The potential for reproduction toxicity was observed in the 13-week dietary study in rats. Atrophy of seminiferous tubules was observed in males at 12,500 ppm (900 mg/kg/day). However, the concern for reproduction toxicity is low since effects occurred at a high dose and a clear NOAEL of 6,250 ppm (460 mg/kg/day) was established. Therefore, the established cRfD will be protective of this effect. In addition, no female reproductive parameters were affected in the developmental toxicity study in rats.

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

i. The toxicity database for benzyl acetate contains the following studies that are adequate to evaluate the potential toxicity of benzyl acetate for infants and children: A thirteen week feeding study in the rat, a 13-week feeding study in the mouse, a developmental toxicity study in the rat, several in vivo and in vitro mutagenicity studies, and carcinogenicity studies in mice and rats via gavage and dietary studies.

ii. Evidence of neurotoxicity and neuronal degeneration seen in a thirteen-week study was determined not to exceed levels of concern since the effects occurred at doses that were well above the limit dose (1,000 mg/kg/day). The established cRfD is 1.10 mg/kg/day therefore is protective of these effects.

iii. Qualitative fetal susceptibility was observed in the developmental study in rats. Maternal (decrease in body weight) and fetal (reduced body weights, increased incidence of dilation of the renal pelvis and skeletal variations) toxicity were observed at 1,000 mg/kg/day, the limit dose. Since fetal toxicity occurs in the presence of maternal toxicity and a clear NOAEL of 500 mg/kg/day was established, the established cRfD (1.10 mg/kg/day) will be protective of these effects. The potential for reproduction toxicity was observed in the 13-week dietary study in rats. Atrophy of seminiferous tubules was observed in males at 12,500 ppm (900 mg/kg/day). However, the concern for reproductive toxicity is low since effects occurred at a high dose and a clear NOAEL of 6,250 ppm (460 mg/kg/day) was established.

iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100% CT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to benzyl acetate in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by benzyl acetate.

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

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to benzyl acetate from food and water will utilize 62.9% of the cPAD for children ages 1 to 2, the population group receiving the greatest exposure.

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

Benzyl acetate is likely to be used as an inert ingredient in pesticide products that are registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to benzyl acetate. Using the exposure assumptions described in this unit for screening-level short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 150 for children ages 1 to 2 and 260 for adults. Because EPA's level of concern for benzyl acetate is a MOE of 100 or below, these MOEs are not of concern.

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

5. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in the dietary carcinogenicity studies in mice and rats, benzyl acetate is not expected to pose a cancer risk to humans.

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

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

Therefore, an exemption from the requirement of a tolerance is established under 40 CFR 180.920 for benzyl aceetate (CAS Reg. No. 140-11-4) when used as an inert ingredient (solvent) in pesticide formulations applied to growing crops only.

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

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

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

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

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

Therefore, 40 CFR chapter I is amended as follows:

This document announces that, on February 3, 2016, OMB approved information collection requirements contained in the Commission's Report and Order, FCC 15-118, published at 80 FR 64354. The OMB Control Number is 3060-1209. The Commission publishes this document as an announcement of the effective date of those information collection requirements.

As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), the FCC is notifying the public that it received OMB approval on February 3, 2016, for the information collection requirements contained in 47 CFR 73.1216, as amended in the Commission's Report and Order, FCC 15-118. Under 5 CFR part 1320, an agency may not conduct or sponsor a collection of information unless it displays a current, valid OMB Control Number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act that does not display a current, valid OMB Control Number. The OMB Control Number is 3060-1209.

The foregoing notification is required by the Paperwork Reduction Act of 1995, Public Law 104-13, October 1, 1995, and 44 U.S.C. 3507.

The total annual reporting burdens and costs for the respondents are as follows:

OMB Control Number: 3060-1209.

OMB Approval Date: February 3, 2016.

OMB Expiration Date: February 28, 2019.

Title: Section 73.1216, Licensee-Conducted Contests.

Form Number: None.

Respondents: Business or other for-profit entities; Not-for-profit institutions.

Number of Respondents and Responses: 20,732 respondents; 20,732 responses.

Estimated Time per Response: 0.1-9 hours.

Frequency of Response: On occasion reporting requirement, Third party disclosure requirement; Recordkeeping requirement.

Obligation to Respond: Required in order to monitor regulatory compliance. The statutory authority for this collection of information is contained in Sections 1, 4 and 303 of the Communications Act of 1934, as amended.

Total Annual Burden: 122,854 hours.

Total Annual Cost: $6,219,300.

Nature and Extent of Confidentiality: There is no need for confidentiality with this collection of information.

Privacy Act Impact Assessment: No impact(s).

Needs and Uses: The Commission's amendments to its “Contest Rule” permit broadcast licensees to comply with their obligation to disclose material contest terms either by broadcasting those terms or by making them available in writing on a publicly accessible Internet Web site. The Commission's rule amendments also define the disclosure obligation in cases where a licensee has chosen to meet that obligation through an Internet Web site. The information collection requirements afford broadcasters more flexibility in the manner of their compliance with the Contest Rule while giving consumers improved access to important contest information.

The enactment of Section 8205 of the Agricultural Act of 2014 (Pub. L. 113-79) establishes permanent authority to conduct Stewardship End Result Contracting projects by adding a new Section 604 to the Healthy Forests Restoration Act of 2003 (HFRA) (16 U.S.C. 6591c). Section 8205 of the 2014 Agricultural Act contains a requirement that the agency use a fire liability provision in all stewardship contracts and agreements that is in substantially the same form as the fire liability provisions contained in the integrated resource timber contract in Forest Service Contract Numbered 2400-13, Part H, Section H.4 and timber sale contracts conducted pursuant to Section 14 of the National Forest Management Act of 1976 (16 U.S.C. 472a).

Beginning in 1998 with the enactment of Section 347 of the Department of the Interior and Related Agencies Appropriation Act, 1999, the Forest Service has been authorized to carry out Stewardship End Result Contracting Projects; first on a pilot basis and then, through a succession of subsequent amendments, this authority was expanded. The enactment of Section 8205 of the Agricultural Act of 2014 sets forth the permanent authority for conducting Stewardship End Resulting Contracting Projects by adding a new Section 604 to the Healthy Forests Restoration Act of 2003. Section 8205 contains a provision that “not later than 90 days after the date of enactment of this section, the Chief of the Forest Service and the Director of the Bureau of Land Management shall issue for use in all contracts and agreements under this section fire liability provisions that are in substantially the same form as the fire liability provisions contained in— (A) integrated resource timber contracts, as described in the Forest Service Contract Numbered 2400-13, Part H, Section H.4; and (B) timber sale contracts conducted pursuant to Section 14 of the National Forest Management Act of 1976 (16 U.S.C. 472a).”

This final rule establishes a new AGAR clause for use in stewardship contracts subject to the FAR. This clause addresses fire liability on Stewardship End Result Contracting, as required in the 2014 Agricultural Act. The text of the clause is closely specified in the law.

USDA solicited comments on the interim rule on May 22, 2014. USDA received two comments at the end of the posted comment period on June 23, 2014.

Both comments were received from the Federal Forest Resource Coalition (FFRC), a national trade association comprised of large and small companies, regional and state associations, county governments, and others concerned about the management of our National Forests and the landscape covered by Bureau of Land Management.

Both comments recommend changes to add clarity and consistency to the language in the regulations. The comments suggest that USDA follow the requirement of implementing a liability clause for IRSC contracts that mirrored Integrated Resource Timber Contracts (IRTC). The comments from FFRC are presented below, along with USDA's responses and are grouped by the Code of Federal Regulations (CFR) section numbers to which they apply.

Comment (1) In Section 436.578, we recommend that you delete “as applicable”. Section 8205 of the Agricultural Act of 2014 states that “. . . the Chief and Director shall issue for use in all [emphasis added] contracts and agreements under this section fire liability provisions . . .”

Comment (2) In Section 452.236-78, we recommend that you change “may be inserted” to “shall be inserted”. Again, Section 8205 of the Agricultural Act of 2014 states that “. . . the Chief and Director shall issue for use in all [emphasis added] contracts and agreements under this section fire liability provisions . . .”

Response: FFRC stated that the plain language in Section 8205 of the Agricultural Act of 2014 (Pub. L. 113-79) makes clear that Congress intended the fire liability provisions to be non-discretionary, both for the issuance of the provision and its use in all contracts. However, they believe that the language in the Interim Rule conveys discretion that is not found in the statute. The Forest Service agrees with both comments and will amend the CFR to read as follows: “the Chief shall issue for use in all contracts and agreements under this section fire liability provisions that are in substantially the same form (16 U.S.C. 472a) for all IRSC solicitations issued after May 22, 2014. Contracts and agreements in effect on May 22, 2014, are not eligible to insert this provision.” The Forest Service believes the aforementioned statement in response to the two comments reflects the intention of the Farm Bill with regards to implementing a fire liability clause for Integrated Resources Services Contracts that mirrors current Timber Sales Contracts. This creates the same fire liability for all Forest Service stewardship contract types.

As a result of public comments received on the interim rule, USDA will amend the CFR to add clarity and consistency that reflects the intention of the Farm Bill with regard to implementing a fire liability clause for IRSCs that mirrors current Timber Sales Contracts.

USDA certifies that this final rule will not have a significant impact on a substantial number of small entities, as defined in the Regulatory Flexibility Act, 5 U.S.C. 601, et seq. There is no additional submission required as a result of this action. The rule will not have a significant impact on the small business community or on a substantial number of small businesses.

The Paperwork Reduction Act does not apply because the final rule does not impose any record keeping or information collection requirements that require approval by the Office of Management and Budget.

The USDA has determined that this final rule falls within this category of actions and that no extraordinary circumstances exist that would require preparation of an environmental assessment or environmental impact statement.

This final rule has been reviewed under USDA procedures and Executive Order 12866 on Regulatory Planning and Review. It has been determined that this is not a significant rule. This rule would not have an annual effect of $100 million or more on the economy, nor would it adversely affect productivity, competition, jobs, the environment, public health and safety, or State or local governments. This final rule would not interfere with an action taken or planned by another agency, nor raise new legal or policy issues. Finally, this final rule would not alter the budgetary impact of entitlement, grant, user fee, or loan programs or the rights and obligations of beneficiaries of such programs. Accordingly, this final rule is not subject to Office of Management and Budget (OMB) review under Executive Order (E.O.) 12866.

The USDA has analyzed this final rule in accordance with the principles and criteria contained in E.O. 12630 and determined that the rule would not pose the risk of a taking of private property.

The USDA has reviewed this final rule under E.O. 12778, Civil Justice Reform. Under this rule, (1) all State and local laws and regulations that conflict with this rule or that impede its full implementation would be preempted; (2) no retroactive effect would be given to this final rule; and (3) it would require administrative proceedings before parties may file suit in court challenging its provisions.

The USDA has considered this final rule under the requirements of E.O. 13132 on Federalism and has determined that this rule conforms to the Federalism principles in the E.O. The rule would not impose any compliance costs on the States; and would not have any substantial direct effects on the States, the relationship between the Federal Government and the States, or the distribution of power and responsibilities among the various levels of government. Moreover, this final rule does not have tribal implications as defined by E.O. 13175, Consultation and Coordination with Indian Tribal Governments, and therefore advance consultation with tribes is not required.

The USDA has reviewed this final rule under E.O. 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or use and has determined that this rule would not constitute a significant energy action as defined in the E.O.

Pursuant to Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538), the USDA assessed the effects of this final rule on State, local, and tribal governments and the private sector. This rule would not compel the expenditure of $100 million or more by State, local, and tribal governments, or by the private sector. Therefore, a statement under Section 202 of the Act is not required.

For the reasons set forth in the preamble, the U.S. Department of Agriculture amends 48 CFR Chapter 4, in the following manner: