Federal Register Vol. 83, No.101,

Background

The National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et seq.), is the United States' basic charter for protection of the environment. The Council on Environmental Quality (CEQ) Regulations for Implementing the Procedural Provisions of the NEPA, published in 40 CFR parts 1500 through 1508 (referred to below as the CEQ regulations), provide a basic regulatory framework for the implementation of NEPA across Federal agencies.

The Office of the Secretary of the U.S. Department of Agriculture (USDA) has set forth departmental policy on the implementation of NEPA in 7 CFR part 1b. Within USDA, the Animal and Plant Health Inspection Service (APHIS) has regulations that set out its procedures for implementing NEPA in 7 CFR part 372 (referred to below as the regulations). APHIS' regulations are designed to ensure early and appropriate consideration of potential environmental effects when APHIS programs formulate policy and make decisions. The regulations also promote effective and efficient compliance with NEPA requirements and integration of other environmental review requirements under NEPA (e.g., 40 CFR 1500.2(c) and 40 CFR 1500.4(k)). Consistent with the requirements of CEQ's NEPA implementing regulations in 40 CFR 1507.3, the APHIS regulations supplement the CEQ regulations and the USDA NEPA implementing regulations to take into account APHIS missions, authorities, and decision making. The APHIS regulations include definitions, categories of actions, major planning and decision points, opportunities for public involvement, and methods of processing different types of environmental documents.

NEPA and the CEQ regulations require all agencies of the Federal Government to incorporate environmental considerations in their planning and decisionmaking. This may include the development of an Environmental Impact Statement (EIS), a detailed statement by the responsible official with every recommendation or report on proposals for legislation and other major Federal actions significantly affecting the quality of the human environment. This statement must cover:

• The environmental impact of the proposed action,

• Any adverse environmental effects which cannot be avoided should the proposal be implemented,

• Reasonable alternatives to the proposed action,

• The relationship between local short-term uses of the human environment and the maintenance and enhancement of long-term productivity, and

• Any irreversible and irretrievable commitments of resources which would be involved in the proposed action, should it be implemented.

The EIS is distinguished from the environmental assessment (EA), which is a concise public document that briefly provides sufficient evidence and analysis for determining whether to prepare an EIS or a finding of no significant impact (FONSI). Actions taken by an agency that do not individually or cumulatively have a significant effect on the human environment may be categorically excluded from the requirement to prepare either an EA or an EIS.

The APHIS regulations were last amended in a final rule published in the Federal Register on February 1, 1995 (60 FR 6000-6005, Docket No. 93-165-3; corrected on March 10, 1995, at 60 FR 13212). The CEQ regulations at 40 CFR 1507.3(a) state that agencies “shall continue to review their policies and procedures and in consultation with the Council to revise them as necessary to ensure full compliance with the purposes and provisions of the Act.” Accordingly, on July 20, 2016, we published in the Federal Register (81 FR 47051-47071, Docket No. APHIS-2013-0049) a proposal 1 to amend the regulations by adding several new types of actions that were not previously covered in the regulations. Accordingly, we also evaluated our regulations and identified changes that would reflect new authorities, activities, and data. The changes we proposed also clarified certain areas of the regulations.

We also proposed to establish or revise categorical exclusions and extraordinary circumstances under which those categorical exclusions would not apply and to revise the requirements generally relating to classification of various actions (e.g., actions normally requiring EISs, actions normally requiring EAs but not necessarily EISs). Upon further consideration and in light of the comments we received, we decided not to finalize the proposed extraordinary circumstances and most of the proposed new program categorical exclusions. Instead, we are making minor adjustments to the language currently found in § 372.5 concerning these subjects to improve clarity and provide further examples of activities that fall into a given class of action or may be subject to categorical exclusion. The proposed additions were accompanied by a reorganization of the regulations, which we are also not finalizing. The structure of the regulations will remain largely identical to that of the current regulations. We may revisit the issue of categorical exclusions, extraordinary circumstances, and classification of actions in a future rulemaking.

We solicited comments concerning our proposal for 60 days ending September 19, 2016. We received 12 comments by that date from advocacy groups, industry associations, and private citizens. They are discussed below by topic, with the exception of any comments received on those portions of the proposed rule we are not finalizing, as described above.

The bulk of the comments we received related to changes we proposed to our categorical exclusions and their associated extraordinary circumstances exceptions. As stated above, in considering those comments, which covered a broad variety of issues in detail, we came to recognize the need to reevaluate our proposed categories and reconsider the scope and effect of those categories.

One commenter stated that since the changes and additions may affect species protected under the Endangered Species Act of 1973 and their designated critical habitats, APHIS must conduct a programmatic consultation with the Fish and Wildlife Service (FWS) and the National Marine Fisheries Service (NMFS).

This rule is administrative in nature and does not affect any listed threatened or endangered species. We consult with FWS and/or NMFS when an analysis of listed species is necessary to arrive at an environmental effects determination. We will continue to consult on any future actions that may affect protected species.

The same commenter said that we should coordinate our efforts concerning NEPA with the existing initiative involving APHIS, the Environmental Protection Agency (EPA), and the Food and Drug Administration (FDA) to modernize agency activities under the Coordinated Framework for the Regulation of Biotechnology.2

APHIS is involved in updating the Coordinated Framework for the Regulation of Biotechnology, which clarifies the relevant existing authorities and roles of the USDA, the FDA, and the EPA. On January 4, 2017, EPA, FDA, and USDA released the 2017 Draft Update to the Coordinated Framework for the Regulation of Biotechnology and accompanying National Strategy for Modernizing the Regulatory System for Biotechnology Products. The original Coordinated Framework for the Regulation of Biotechnology and the 2017 Draft Update identify which types of topics trigger NEPA analyses within each agency. The finalized update of the Coordinated Framework for the Regulation of Biotechnology will continue to align with the regulations, and may facilitate further regulations.

Another commenter characterized the proposed action as APHIS scaling back its NEPA obligations, despite ongoing disputes over the scope of APHIS' duties in this area.

Contrary to the commenter's assertion, this rule will improve transparency and clarity regarding APHIS activities under NEPA. Further, we will continue to apply an appropriate level of environmental documentation to every action.

Another commenter stated that they had included suggestions for corresponding changes to the NEPA implementing regulations discussed here as part of a comment submitted in connection with a notice of intent to prepare an EIS published in the Federal Register on February 5, 2016 (81 FR 6225-6229, Docket No. APHIS-2014-0054) titled “Environmental Impact Statement; Introduction of the Products of Biotechnology.” 3 The commenter also said that this action may need to be revised in light of any changes to the NEPA regulations made in this final rule.

Due to the nature of APHIS rulemaking, we cannot consider the content of comments submitted on other rules. The notice referenced by the commenter has yet to be finalized; however, if changes to the NEPA implementing regulations are necessary as a result of that action, we will make those changes accordingly via subsequent rulemaking.

One commenter pointed out several typographical errors in the preamble language and the regulatory text of the proposed rule. We have corrected the errors in the regulatory text. The preamble language is not repeated in this final rule.

In § 372.4, which contains definitions of various terms used in the regulations, we proposed to revise two existing definitions and add definitions for two additional terms. We are not finalizing the two proposed additional definitions. We determined that a definition for “Agency official responsible for environmental review” is unnecessary because the information we wished to convey can already be found in the definition for “Environmental unit.” We are not finalizing the definition for “Extraordinary circumstances” because, as stated previously, we are not finalizing the proposed revisions concerning extraordinary circumstances. The revisions we are finalizing remain consistent with the CEQ regulations.

One commenter suggested we add a definition for the term “conventional,” given that we proposed a change from “routine measures” to “conventional measures” throughout the regulations due to prior confusion about the meaning of “routine.” The commenter argued that the word “conventional” has as much potential to cause confusion as the word “routine.”

Uses of the term “conventional measures” in place of “routine measures” were only found in those sections we are not finalizing in this document.

We proposed to set out a description of actions APHIS takes that normally require EAs but not necessarily EISs in § 372.6 (§ 372.5(b) in the final rule). An action in this class will typically be characterized by its limited scope (particular sites, species, or activities).

We are clarifying the way in which we assess potential environmental impacts in connection with an action normally requiring an EA but not necessarily an EIS. Any effects of the action on environmental resources (such as air, water, soil, plant communities, animal populations, or others) or indicators (such as dissolved oxygen content of water) can be reasonably identified.

Proposed paragraph (d) of § 372.6 (§ 372.5(b)(4) in the final rule) indicated that approvals and issuance of licenses and permits for proposals involving regulated genetically engineered or regulated nonindigenous species would normally require an EA but not necessarily an EIS, unless they are categorically excluded. One commenter proposed that we refer to “genetically engineered organisms” separately from regulated nonindigenous species. Two commenters pointed out that we neglected to specifically exclude actions that are categorically excluded in the language of this section.

We agree with the first commenter's suggestion to use the word “organisms” and have changed the term used in that section to “genetically engineered organisms or products.” Reference to genetically engineered products is necessary in some parts of the regulations to adequately cover veterinary biologics products, such as genetically engineered subunit proteins, plasmid vectors, and other constructs that are not organisms. We agree with the point raised by the last two commenters and have added the requested language to the introductory paragraph of § 372.5(b).

Another commenter made a recommendation regarding the comingling threshold level for genetically engineered and conventional products. The commenter also stated that third-party field testing on crops with a high risk of comingling should occur.

As the proposal did not relate to such a threshold or such inspections, these comments are outside the scope of this rulemaking.

Proposed paragraph (e) of § 372.6 (§ 372.5(b)(5) in the final rule) indicated that activities to reduce damage or harm by a specific wildlife species or group of species (such as deer or birds), or to reduce a specific type of damage or harm (such as protection of agriculture from wildlife depredation and disease, management of rabies in wildlife, or protection of threatened or endangered species) normally require an EA but not necessarily an EIS, unless they are categorically excluded.

One commenter stated that a Federal court has determined that State-wide analysis of Wildlife Services' (WS) wolf damage management activities in the State of Washington violated NEPA due to the absence of an EIS in the case of Cascadia Wildlands v. Woodruff (151 F. Supp. 3d 1153 (W.D. Wash. 2015)). The commenter argued that such State-wide plans have significant environmental impacts and thus must appropriately be analyzed in an EIS. The commenter went on to say that State-wide or district-wide program analyses will allow WS to evade any assessments of compliance with Federal land-use plans (e.g., forest plans and resource management plans) that govern management of lands on which it conducts its activities. The commenter argued that State-wide or district-wide analyses fail to consider that impacts may be concentrated in certain areas, as WS generally relies upon average numbers killed State-wide or district-wide.

We disagree with the commenter's characterization of Cascadia Wildlands v. Woodruff and with the commenter's assertion that the case sets a precedent whereby all State-wide plans require preparation of an EIS. The court did not order WS to complete an EIS for its wolf damage management activities in Washington. WS coordinates all activities with land management agencies on lands under their jurisdiction. For example, memoranda of understanding between WS and the U.S. Forest Service, and between WS and the Bureau of Land Management identify the authorities, coordination requirements, and responsibilities of each agency, ensuring that land-use plans are considered, and that potential conflicts with other land uses are identified and avoided or minimized. In addition, WS uses EAs to involve other agencies with applicable jurisdiction, including land and wildlife management agencies, inviting formal agency cooperation and or comments as appropriate. WS also includes a formal public comment period on all of its EAs to ensure that all issues and concerns are considered. As shown in the document entitled “Proposed Amendments to National Environmental Policy Act Implementing Procedures (7 CFR part 372) Substantiating Document for Proposed Amendments,” WS EAs have repeatedly demonstrated that its activities have not had significant impacts on the environment.4

Proposed paragraph (g) of § 372.6 (§ 372.5(b)(7) in the final rule) indicated that determinations of nonregulated status for genetically engineered organisms normally requires an EA but not necessarily an EIS, unless categorically excluded. One commenter suggested that we add language specifically stating that an EA would be required except in those cases where the action fits into one of the categorical exclusion categories associated with such actions.

While we are not adding language specifying that an EA would be required except in those cases where the action fits into one of the categorical exclusion categories associated with such actions in § 372.5(b)(7) as suggested by the commenter, we added language in the introductory paragraph of § 372.5(b) stipulating that all of the example actions described in § 372.5(b)(1) through (7) normally require an EA but not necessarily an EIS, unless categorically excluded.

Another commenter stated that extensions of determinations of nonregulated status for genetically engineered organisms were in violation of NEPA. The commenter argued that while such extensions are often granted to similar organisms, there may still be agronomic or geographic differences that would result in significant environmental impacts. At a minimum, the commenter said, these extensions warrant the preparation of EAs in order to better evaluate the potential environmental impacts of the genetically engineered organisms. This rule does not address whether extensions of genetically engineered organisms are in violation of NEPA. Moreover, we do not explicitly identify extensions of determinations of nonregulated status for genetically engineered organisms in the discussion of exceptions for categorically excluded actions found in § 372.5(d). If the decisionmaker determines that a categorically excluded action may have the potential to affect significantly the quality of the human environment, then an EA or an EIS will be prepared. Agronomic and geographic differences are among the factors that the decisionmaker will consider when determining whether a particular extension application will be categorically excluded or if preparation of an EA or EIS is required.

Another commenter suggested that we add licensing and permitting of commercial breeding operations regulated under the Animal Welfare Act to the list of actions normally requiring EAs but not necessarily EISs.

Commercial breeding operations are not specifically listed as one of the examples of such actions given in § 372.5(b) for EAs. APHIS intends to assess all animal welfare licensing and registration applications to determine if they are eligible for a categorical exclusion or if circumstances exist that will necessitate the preparation of an EA or EIS. We will document our conclusions.

We received a number of additional comments relating to the need for EAs or EISs in connection with the licensing of commercial breeding operations. Those comments are addressed below in a section entitled, “Comments Regarding Commercial Breeding Operations.”

Proposed § 372.8 (§ 372.5(c) in the final rule) lists various categorically excluded actions. We proposed to make changes to paragraph (a) of § 372.8 (§ 372.5(c)(1)(i) in the final rule) in order to expand the list of substances that may be used as part of a conventional measure (a term not finalized in this rule; instead we have retained the original term, “routine measure”), subject to certain conditions, to include the use of pesticides, chemicals, drugs, pheromones, contraceptives, or other potentially harmful substances, materials, and target-specific devices or remedies. Previously, the list of substances referred only to chemicals, pesticides, or other potentially hazardous or harmful substances, materials, and target-specific devices or remedies.

While we are not finalizing the proposed language, we will respond to the comment because the current regulations cite the use of pesticides, chemicals, and other potentially hazardous or harmful substances. Two commenters objected to the inclusion of such elements in any categorically excluded action, saying that their use often has significant impacts, which require NEPA analysis. One commenter specifically cited the growth-promotion drugs ractopamine and monensin, which the commenter argued can leach into groundwater, and the growth-promotion drug tylosin, which has been linked to antibiotic resistance.

APHIS does not use these or other growth-promotion drugs in any programs, and there are no actions in which we would consider their usage.

The other commenter used as an example those pesticides classified as “restricted use pesticides” by the EPA, stating these are pesticides that EPA has determined are likely to cause “unreasonable adverse effects on the environment” if they are used “without additional regulatory restrictions.” The commenter went on to classify the EPA's oversight of restricted use pesticides as predominantly focused on acute exposure and therefore inadequate to protect against risks posed by regular low-level exposure, even though the pesticides may aggregate in the environment, causing harm via long-term, low-level exposure to humans and animals.

APHIS develops and uses methods that are proven to be effective, efficient in their performance, and safe in their execution. APHIS uses pesticides in accordance with all EPA requirements. As shown in the document entitled “Proposed Amendments to National Environmental Policy Act Implementing Procedures (7 CFR Part 372) Substantiating Document for Proposed Amendments,” these methods were analyzed in prior environmental reviews, risk assessments, and/or are monitored to demonstrate or determine whether their use could significantly impact the human environment. This includes a number of use patterns and any program mitigation measures (including contained facilities, field sites, and pens) for pesticides, chemicals, or other potentially hazardous or harmful agents. Many of these use patterns have long been known and studied by APHIS, and APHIS has seen no record of significant environmental impacts. Our NEPA analyses consider chemical movement, degradation, environmental impacts, exposure, and risk for all actions, including those actions subject to categorical exclusion.5 This includes both potential acute and chronic risks. If any proposed activity meets any of the criteria listed in § 372.5(d), then an EA or EIS will be prepared.

We are finalizing a group of categorically excluded actions that concern research and development activities limited in magnitude, frequency, and scope that occur in laboratories, facilities, pens, or field sites. The location and organization of this section is taken from the current regulations; however, we are incorporating some of our proposed language in a new list of examples of such activities.

In § 372.8(j)(1) (§ 372.5(c)(2)(i)(A) in the final rule) we proposed to allow for the categorical exclusion of the inoculation or treatment of discrete herds of livestock or wildlife undertaken in contained areas (such as a barn or corral, a zoo, an exhibition, or an aviary). One commenter requested that we provide further guidance on the concept of “discrete herds of livestock or wildlife undertaken in contained areas” either via final rule or through issuance of a guidance document.

For clarity, we revised this language to cover only those vaccination trials that occur on groups of animals in areas designed to limit interaction with similar animals, or include other controls as needed to mitigate potential risk.

Section 372.8(j)(2) (§ 372.5(c)(2)(i)(D) in the final rule) states that an example of a categorically excluded research and development activity is the use of vaccinations or inoculations, including new vaccines (e.g., vaccines with components inserted through genetic engineering technologies) and applications of existing vaccines to new species provided that the project is conducted in a controlled and limited manner, and the impacts of the vaccine can be predicted. A commenter stated that the use of genetically engineered vaccines and other novel technologies may result in impacts that require analysis under NEPA.

In the case of genetically engineered vaccines and other novel technologies, if any the criteria in § 372.5(d) apply then an EA or EIS will be prepared. As shown in the document entitled “Proposed Amendments to National Environmental Policy Act Implementing Procedures (7 CFR Part 372) Substantiating Document for Proposed Amendments,” we note that, based on more than 20 years of experience, APHIS' Center for Veterinary Biologics has found that the impact of new vaccines and inoculations stays within the vaccinated animal.6

We also proposed that activities could not be categorically excluded if a previously licensed or approved biologic has been subsequently shown to be unsafe, or if it would be used at substantially higher dosage levels or for substantially different applications or circumstances than the use for which the product was previously approved. One commenter argued that an EA should not necessarily be required in every instance where a substantially higher dose or substantially different application or use circumstance is being developed and recommended we remove that language from the regulations. The commenter said that APHIS should evaluate each situation on a case-by-case basis.

While we agree that an EA is not always required where a substantially higher dose or substantially different application or use circumstance is proposed, we are making no changes to the proposed language. We will continue to consider each case individually, as the commenter suggested. An EA or EIS would not need to be prepared if we determine that a substantially higher dose or substantially different application or use circumstance for a previously licensed or approved biologic will not impact the environmental or safety factors associated with use of that biologic.

Proposed § 372.9 (§ 372.5(c)(3) in the final rule) contained examples of various categorically excluded actions under the heading of licensing and permitting. In the preamble to the proposed rule, we explained that licensing and permitting are administrative actions for the agency, and generally occur in support of actions that later undergo analysis in an EIS or EA. To require a separate NEPA analysis for each license or permit does not allow expedient action to serve the public, and would promote piecemeal analyses.

One commenter objected to this characterization, saying that it would be a contravention of APHIS' obligations under NEPA because any individual action within a program may have significant effects and must be subject to individualized NEPA review. The commenter also argued that it is in the public interest to undertake individualized reviews where warranted.

APHIS is not trying to evade or ignore its obligations under NEPA. The CEQ regulations at 40 CFR 1508.4 give agencies the authority to identify categorical exclusions in their NEPA implementing regulations, which is what APHIS seeks to do here. It is important to understand that, in addition to EAs and EISs, categorical exclusions are consistent with NEPA. Categorical exclusions are categories of actions, which do not individually or cumulatively have a significant effect on the human environment, and are recognized as such in the agency's implementing procedures. Use of a categorical exclusion has, and will continue to include, individualized reviews prior to issuance.

Another commenter said that we provided insufficient analysis for the determination that licensing and permitting are categorically exempt. The commenter went on to say that it is unclear whether this provision is meant to apply to licensing conducted under Animal Welfare Act (AWA; Laboratory Animal Welfare Act of 1966, as amended Public Law 89-544, 7 U.S.C. 2131-2159) licensing. The commenter argued that AWA licensing actions have enormous potential for environmental harm, and so will frequently warrant at least preparation of an EA. The commenter stated that, even if there were a categorical exclusion for commercial breeder licensing, at a minimum it should specify exceptions to that categorical exclusion. The commenter found that the proposed definition, evaluation criteria, and list of extraordinary circumstances set too high a bar for judging whether an action may have a significant environmental effect.

The regulations already provide a categorical exclusion for licensing and permitting, and identify a wide variety of routine measures that could result in authorizations and approvals. Since these categories already existed within the regulations and were effective for years, we did not include additional analysis in the proposed rule. We do not agree with the commenter's position regarding our ability to evaluate an action for significant environmental effect. On the contrary, we find that the general exceptions to categorical exclusions identified in § 372.5(d) will allow us to adequately address concerns about the potential for significant impacts to the environment pursuant to AWA licensing, because this section allows the decisionmaker to determine that a categorically excluded action may have the potential to affect “significantly” the quality of the “human environment.” For additional discussion on the rest of the commenter's points specific to licensing of commercial breeding operations, please see the section below entitled, “Comments Regarding Commercial Breeding Operations.”

Proposed paragraph (a)(2) of § 372.10 (§ 372.5(c)(2)(i)(B) in the final rule) contained a categorical exclusion for the evaluation of uses for chemicals not specifically listed on the product label, as long as they are used in a manner designed to limit potential effects to nontarget species such that there are no individual or cumulative impacts on the human environment. A commenter stated that categorical exclusions for evaluation of novel chemical uses cannot be employed under NEPA because their application and contact with nontarget species may result in unintended environmental, human health, or ecological impacts.

Our research and testing in this area is limited to serving Agency needs, and does not encompass broadly based or basic research. We have added the stipulation that such evaluation and use must be pursuant to applicable Federal authorizations to clarify the relatively narrow application of this categorical exclusion. Use must be limited in magnitude, frequency, and scope, and it can only occur in laboratories, facilities, pens, or field sites. We also note that this is not a new categorical exclusion, only an enhanced description of activities that did not demonstrate environmental impacts in the past.

Proposed paragraph (a)(6) (§ 372.5(c)(2)(ii) in the final rule) contained the prior categorical exclusion for the development and production of sterile insects. We are also including the release of sterile insects as well.

The same commenter argued that the development and production of sterile insects may include novel methods for inducing sterility, which would require NEPA analysis. The commenter said that the field release of genetically engineered insects may have significant human health and ecological impacts.

APHIS does not develop, approve, or release genetically engineered sterile insects. Were that to change in the future, we would consider any potential environmental impacts. Any novel methods to develop sterile insects would be subject to the criteria listed in § 372.5(d).

We are adding a new section describing the process APHIS follows to develop environmental documentation when conducting a rapid response to an emergency. APHIS frequently takes important emergency actions to prevent the spread of animal and plant pests and diseases. Without emergency action to control the spread of these pests and diseases, there is a potential for significant impacts on the human environment. One commenter encouraged APHIS to take the need to control a plant disease outbreak or other exigency into account under NEPA, including in situations where a categorical exclusion does not apply.

APHIS will take NEPA into account in the event there is a need to control a plant disease outbreak or other exigency. We recognize the need to deal quickly, effectively, and efficiently with any emergency situation that may arise. We mitigate foreseeable environmental effects to the extent practicable.

Another commenter observed that our proposed text was based on CEQ regulations, but added that there have been legal challenges to this portion of those regulations. The commenter stated that, while there has been no ruling on whether the portion of the CEQ regulations dealing with rapid response to an emergency is invalid, it was noted that allowing an emergency to encompass anything more than significant, unanticipated occurrences, such as natural disasters, as opposed to circumstances of the agency's own making, seemed at odds with NEPA as this may allow for the evasion of NEPA review. The commenter concluded that APHIS should therefore specify that an emergency exists in instances of significant, unanticipated occurrences, such as natural disasters only, and that an emergency cannot be a result of the agency's own making.

Merely adding the concept that an emergency cannot be a result of the agency's own making does not account for the types of emergency actions APHIS may need to cope with, such as unanticipated or unforeseen impacts associated with a pest or disease outbreak. In an emergency, our primary concerns include the consequences of a delayed response. The intent of this section is to create the flexibility necessary to begin a response to the emergency, regardless of cause. This section does not allow APHIS to evade NEPA analyses; instead, it adjusts the usual timeframe and sequence for analysis of any potential impact during emergencies. The timing for NEPA compliance for all non-emergency and post-emergency actions remains unchanged.

As stated previously, we received a number of comments from the Humane Society of the United States (HSUS) relating to the need for EAs or EISs in connection with the licensing of commercial breeding operations. HSUS expressed surprise that we did not mention the licensing of commercial breeding operations in the proposed rule and observed that we provided no guidance for applying NEPA standards to the licensing and regulation of these operations. They disagreed with our assessment that the approval and issuance of licenses is properly categorized as administrative, and stated that we failed to articulate what mitigation measures are in place related to the environmental damage at commercial breeding facilities, nor how any such measures would render those environmental effects insignificant. Finally, they argued that a programmatic assessment of commercial breeders, brokers, and transporters is compulsory, and the regulations should clearly convey that certain individual AWA license approvals may require an individual EA or EIS.

The AWA provides for the licensing of dealers, exhibitors, and registration of research facilities, and transporters (intermediate handlers and carriers). The associated standards provide specific requirements for regulated entities under this Act (7 CFR 371.7; 9 CFR chapter 1, parts 1 through 12 (particularly part 3, Standards)). When we propose modifications to the AWA regulations, we solicit and consider public comments to those specific provisions. The NEPA regulations are not the correct place to create or modify requirements for licensing under the authority of the AWA.

Under the AWA, the action of issuing a license consists of administrative handling of applications. In practice, this means we assess forms for completeness and schedule appropriate inspections. We inspect the facilities, and they must be in compliance prior to the issuance of a license or registration. The criteria for denial of an initial application are not discretionary (9 CFR 2.11)—all who meet the requirements are licensed or registered. Potential impacts to the environment do not occur through the act of processing an application to issue a license or registration; instead, they may occur when an individual facility is noncompliant with the standards of humane care, handling, and transportation. Regulated entities are required to comply with the standards associated with their license or registration. Based on the frequency of inspections for facilities, potential environmental impacts resulting from noncompliance are expected to be localized to a specific site, short-term in duration, and completely mitigated by the corrective actions of the facility to comply with the regulations. We carefully considered the suggestion that a programmatic assessment is necessary, and find changes to the NEPA regulations are not the correct place to address these concerns. Programmatic reviews precede proposed changes to topic-specific regulations as they occur.

HSUS said that common aerosols associated with feces and urine at puppy mills that impact air quality the most are ammonia, hydrogen sulfide, methane, and carbon dioxide. They further pointed out that dogs themselves also produce methane, a potent greenhouse gas, and these combined emissions pose a serious environmental threat. Additionally, they stated that vehicle emissions from animal transporters compound this threat and should be taken into consideration, arguing that while very little is known about the bacterial and particulate emissions of animal transport vehicles which travel across the United States, they undoubtedly emit tons of harmful gases and particulates into the air while traveling between breeder and broker or pet shop.

As stated previously, APHIS' authority under the AWA is limited to the issuance of licenses, which is an administrative act with no environmental implications. EPA, not APHIS, has authority to regulate waste materials, disposal, and emissions.

HSUS also said that decomposition of dead dogs at commercial breeding operations can contribute to soil, air, and water pollution. They stated that improper mortality management can lead to environmental contamination and claimed that dead dogs have been found scattered or improperly disposed of at a number of USDA licensed facilities.

The AWA regulations in 9 CFR 3.1(f) require facilities with dogs to properly dispose of waste and dead animals in a manner that minimizes contamination and disease risks. APHIS standards (9 CFR part 3) are established by species, and do not differ by licensee or registrant. Beyond that, State and local laws determine how dead animals are disposed of within any given jurisdiction, and APHIS works with local jurisdictions during emergencies. If a mass animal health event were to lead to high mortality levels, then APHIS would likely be involved in the disposal of those carcasses as part of a joint local, State, and Federal emergency response effort.

HSUS identified noise pollution as another environmental harm associated with large-scale commercial dog breeders. They claimed that barking dogs can reach decibel levels on par with abrasive blasting or demolition at a construction site or even an ambulance siren and recommended that noise studies, as commonly performed by many localities, should be incorporated into EAs of commercial breeding operations.

As the commenter correctly points out, localities vary in their approaches to the regulation of noise. We believe that local and State regulators are better situated to assess and regulate ambient noise standards, which are then applicable to all residents of that jurisdiction.

HSUS stated that, even if an EIS is not automatically warranted in most cases, large-scale commercial breeding operations raise enough environmental concerns that APHIS should routinely be preparing EAs prior to issuing a new license for a breeding facility.

Applicants, excepting those whose operations meet the de minimis standards set out by APHIS, must demonstrate compliance with the AWA and its regulations in order to receive a license. The regulations establish specifications for the humane handling, care, treatment, and transportation of the species. While it is possible the regulations may change based on public comments we receive as we consider modifying program-specific rules, this NEPA implementing regulation is not the correct place to consider this issue. We ensure appropriate NEPA documentation is prepared for all of our proposed actions. That may take the form of a categorical exclusion, an EA, or an EIS.

We are changing all references to the “administrative record” to references to the “record” because the term “administrative record” is not the accurate use of a legal term of art.

We are also making several minor edits to improve the clarity, focus, and brevity of the regulations overall.

Therefore, for the reasons given in the proposed rule and in this document, we are adopting the proposed rule as a final rule, with the changes discussed in this document.

This final rule has been determined to be significant for the purposes of Executive Order 12866 and, therefore, has been reviewed by the Office of Management and Budget.

This final rule is expected to be an Executive Order 13771 deregulatory action as it imposes no additional costs on affected entities and individuals, and will likely benefit those businesses and individuals regulated by APHIS that participate in the NEPA process.

We have prepared an economic analysis for this rule. The economic analysis provides a cost-benefit analysis, as required by Executive Orders 12866 and 13563, which direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. The economic analysis also examines the potential economic effects of this rule on small entities, as required by the Regulatory Flexibility Act. The economic analysis is summarized below. Copies of the full analysis are available on the Regulations.gov website (see footnote 1 in this document for a link to Regulations.gov) or by contacting the person listed under FOR FURTHER INFORMATION CONTACT.

The rule amends the APHIS regulations that set forth the procedures for implementing NEPA. The amendments to the regulations are designed to improve the clarity and effectiveness of the procedures for implementing NEPA, such as by providing new examples for when we will complete an environmental impact statement or an environmental analysis for an action and outlining an environmental documentation process to be used in emergencies.

APHIS has determined that the rule will not have a significant economic impact on a substantial number of small entities. Some entities will experience time and money savings, but the savings will benefit only a few entities each year. The rule will also serve to clarify the regulations and make the NEPA process more transparent. These actions, although beneficial, are not expected to have a significant economic impact on affected entities. The rule imposes no additional costs on affected entities and individuals or on APHIS.

Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action will not have a significant economic impact on a substantial number of small entities.

This program/activity is listed in the Catalog of Federal Domestic Assistance under No. 10.025 and is subject to Executive Order 12372, which requires intergovernmental consultation with State and local officials. (See 2 CFR chapter IV.)

This rule has been reviewed in accordance with the requirements of Executive Order 13175, Consultation and Coordination with Indian Tribal Governments. Executive Order 13175 requires Federal agencies to consult and coordinate with tribes on a government-to-government basis on policies that have Tribal implications, including regulations, legislative comments or proposed legislation, and other policy statements or actions that have substantial direct effects on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes.

APHIS has assessed the impact of this rule and determined that this rule does not, to our knowledge, have Tribal implications that require tribal consultation under Executive Order 13175.

This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule: (1) Preempts all State and local laws and regulations that are inconsistent with this rule; (2) has no retroactive effect; and (3) does not require administrative proceedings before parties may file suit in court challenging this rule.

This final rule revises the regulations that guide APHIS employees in NEPA analysis and documentation for animal and plant health management, wildlife damage management, and animal welfare management activities. CEQ regulations do not require agencies to prepare a NEPA analysis or document before establishing agency procedures that supplement the CEQ regulations for implementing NEPA, and thus no NEPA document was prepared for this final rule. Agencies are required to adopt NEPA procedures that establish specific criteria for, and identification of, three categories of actions: Those that require preparation of an EIS; those that require preparation of an EA; and those that are categorically excluded from further NEPA review (40 CFR 1507.3(b)). Agency NEPA procedures assist agencies in the fulfillment of agency responsibilities under NEPA, but are not the agency's final determination of what level of NEPA analysis is required for a particular proposed action. The requirements for establishing agency NEPA procedures are set forth at 40 CFR 1505.1 and 1507.3.

This final rule contains no information collection or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

Accordingly, we are amending 7 CFR part 372 as follows:

In FR Doc. 2018-09501, appearing on page 19906 in the Federal Register of Monday, May 7, 2018, the following correction is made:

On page 19906, in the third column, the Uniform Resource Locator (URL) “https://www.rd.usda.gov/publications/regulations-guidlines/rural-utilities-service-audit” is corrected to read “https://www.rd.usda.gov/publications/regulations-guidelines/bulletins/program-accounting”.

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2016-11-02, Amendment 39-18529 (81 FR 33371, May 26, 2016) (“AD 2016-11-02”). AD 2016-11-02 applied to all Bombardier, Inc., Model CL-600-2C10 (Regional Jet Series 700, 701, & 702) airplanes; Model CL-600-2D15 (Regional Jet Series 705) airplanes; Model CL-600-2D24 (Regional Jet Series 900) airplanes; and Model CL-600-2E25 (Regional Jet Series 1000) airplanes. The NPRM published in the Federal Register on June 12, 2017 (82 FR 26864). The NPRM was prompted by reports of loose or missing fasteners and collars on the upper and lower engine pylon structure common to the upper and lower pylon skin panels and engine thrust fitting. The NPRM proposed to continue to require the repetitive inspections of the upper and lower engine pylons for protruding, loose, or missing fasteners; and repair if necessary. The NPRM also proposed to require replacement of affected fasteners, which terminates the inspections. We are issuing this AD to prevent protruding, loose, or missing fasteners, which could result in structural failure of the engine pylons.

Transport Canada Civil Aviation (TCCA), which is the aviation authority for Canada, has issued Canadian Airworthiness Directive CF-2016-10R1, dated July 8, 2016 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all Bombardier, Inc., Model CL-600-2C10 (Regional Jet Series 700, 701, & 702) airplanes; Model CL-600-2D15 (Regional Jet Series 705) airplanes; Model CL-600-2D24 (Regional Jet Series 900) airplanes; and Model CL-600-2E25 (Regional Jet Series 1000) airplanes. The MCAI states:

Related investigative actions include measurements of the attach holes in the engine pylon upper structure and special detailed visual inspections for cracks in the engine pylon structure. Corrective actions include repair. You may examine the MCAI in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-0530.

You may examine the MCAI in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-0530.

We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the NPRM and the FAA's response to each comment.

Mesa Airlines suggested that Bombardier Service Bulletin 670BA-54-007, dated May 13, 2016, be included in paragraph (l), “Credit for Previous Actions,” of the proposed AD. The commenter did not provide justification for its request. We infer that the commenter made this request to provide credit for operators that completed the actions in Bombardier Service Bulletin 670BA-54-007, dated May 13, 2016, prior to the effective date of the proposed AD.

We do not agree that the commenter's requested change is needed. Paragraph (f) of this AD states that the actions specified in this AD must be accomplished “unless already done.” The phrase “unless already done” provides credit for accomplishment of the actions required by paragraph (j) of this AD, if done in accordance with the Accomplishment Instructions of Bombardier Service Bulletin 670BA-54-007, dated May 13, 2016, prior to the effective date of this AD. Therefore, we have not changed this AD in this regard.

Bombardier requested that Task 54-51-01-220-801, “Detailed Inspection of the Engine Pylon Rib and Skin Fasteners,” to Chapter 54, “Nacelle/Pylons,” to Part 2 of the Bombardier CRJ700/900/1000 Aircraft Maintenance Manual (AMM), be required by paragraph (g) of the proposed AD in lieu of Bombardier Temporary Revision (TR) 54-0007, dated March 8, 2016, to the CRJ700/900/1000 AMM. The commenter stated that Bombardier TR 54-0007 was incorporated into Revision 52 of the Bombardier CRJ700/900/1000 AMM, and that the AMM is currently at Revision 56.

We partially agree with the commenter's request. We agree to include Task 54-51-01-220-801, “Detailed Inspection of the Engine Pylon Rib and Skin Fasteners,” to Chapter 54, “Nacelle/Pylons,” to Part 2 of the Bombardier CRJ700/900/1000 AMM as a method of compliance in paragraph (g) of this AD, but we do not agree to remove Bombardier TR 54-0007, dated March 8, 2016, to the Bombardier CRJ700/900/1000 AMM. We have revised paragraph (g) of this AD to include both Task 54-51-01-220-801, “Detailed Inspection of the Engine Pylon Rib and Skin Fasteners,” to Chapter 54, “Nacelle/Pylons,” to Part 2 of the Bombardier CRJ700/900/1000 AMM, CSP B-001, Revision 56, dated September 25, 2017; and Bombardier TR 54-0007, dated March 8, 2016. This revision provides operators with an option to use either service document to accomplish the required action.

We reviewed the available data, including the comments received, and determined that air safety and the public interest require adopting this AD with the changes described previously and minor editorial changes. We have determined that these changes:

• Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM.

We also determined that these changes will not increase the economic burden on any operator or increase the scope of this AD.

Bombardier, Inc., issued Service Bulletin 670BA-54-007, dated May 13, 2016. This service information describes procedures for replacing fasteners and collars, including applicable related investigative and corrective actions.

Bombardier, Inc., also issued Repair Engineering Order 670-54-51-034, “Repair for Missing or Loose/Protruding Fasteners in Upper and Lower Pylon Skins FS 1088—FS 1098, PBL 69.3 L & RHS,” Revision A, dated April 20, 2016. This service information describes procedures for repair, including applicable related investigative and corrective actions.

In addition, Bombardier, Inc., issued TR 54-0007, dated March 8, 2016, to the CRJ700/900/1000 AMM; and Task 54-51-01-220-801, “Detailed Inspection of the Engine Pylon Rib and Skin Fasteners,” to Chapter 54, “Nacelle/Pylons,” to Part 2 of the Bombardier CRJ700/900/1000 AMM, CSP B-001, Revision 56, dated September 25, 2017. This service information describes procedures for a detailed visual inspection for protruding, loose, or missing fasteners of the left-hand and right-hand upper and lower engine pylons. The content of these documents is nearly identical, except for labels on the figures; we have chosen to incorporate both documents by reference so that either may be used to comply with certain requirements of this AD.

This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

We estimate that this AD affects 273 airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

We estimate the following costs to do any necessary repairs that will be required based on the results of the inspection. We have no way of determining the number of aircraft that might need these repairs:

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes to the Director of the System Oversight Division.

We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

1. Is not a “significant regulatory action” under Executive Order 12866;

2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);

3. Will not affect intrastate aviation in Alaska; and

4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

Discussion

We issued AD 2018-06-10, Amendment 39-19230 (83 FR 13401, March 29, 2018), (“AD 2018-06-10”), for certain Honda Aircraft Company LLC Model HA-420 airplanes. AD 2018-06-10 required incorporating a temporary revision into the airplane flight manual and replacing faulty power brake valves upon condition. AD 2018-06-10 resulted from reports of unannunciated asymmetric braking during ground operations and landing deceleration. We issued AD 2018-06-10 to detect failure of the power brake valve. The unsafe condition, if not addressed, could result in degraded braking performance and reduced directional control during ground operations and landing deceleration.

Since we issued AD 2018-06-10, we were notified by Honda Aircraft Company that Service Bulletin SB-420-32-001, dated January 8, 2018, contains a typographical error in the serial number effectivity, which was also used as the basis for the Applicability section of AD 2018-06-10. The service bulletin incorrectly listed the applicable Model HA-420 airplane serial number effectivity as 42000011 through 4200089 instead of 42000011 through 42000089. We are issuing this AD to address the unsafe condition on these products by correcting the inadvertent serial number error.

We reviewed Honda Aircraft Company Service Bulletin SB-420-32-001, Revision B, dated April 16, 2018. The service information describes procedures for replacing a defective PBV with an improved design PBV. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

We are issuing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the same type design.

This AD requires inserting a temporary revision into the AFM, which may be performed by the owner/operator (pilot) holding at least a private pilot certificate and must be entered into the airplane records showing compliance with this AD in accordance with 14 CFR 43.9 (a)(1)-(4) and 14 CFR 91.417(a)(2)(v). The record must be maintained as required by 14 CFR 91.417, 121.380, or 135.439. This AD also requires replacing the installed PBV, P/N HJ1-13243-101-005 or P/N HJ1-13243-101-007, with an improved PBV, P/N HJ1-13243-101-009, if a defective PBV is detected during the required pilot checks as specified in the temporary revision. In addition, this AD provides an optional terminating action for the temporary revision into the AFM by replacing the installed PBV with the improved PBV, P/N HJ1-13243-101-009.

We consider this AD interim action. We are currently considering requiring replacement of the installed PBV, P/N HJ1-13243-101-005 or P/N HJ1-13243-101-007, with an improved part, which will constitute terminating action for the temporary revision to the AFM. However, the planned compliance time for the replacement of the PBV would allow enough time to provide notice and opportunity for prior comment on the merit of the replacement.

An unsafe condition exists that requires the immediate adoption of this AD without providing an opportunity for public comments prior to adoption. The FAA has found that the risk to the flying public justifies waiving notice and comment prior to adoption of this rule because failure of the PBV could cause degraded braking performance and reduced directional control during ground operations and landing deceleration. Therefore, we find good cause that notice and opportunity for prior public comment are impracticable. In addition, for the reason stated above, we find that good cause exists for making this amendment effective in less than 30 days.

This AD is a final rule that involves requirements affecting flight safety, and we did not provide you with notice and an opportunity to provide your comments before it becomes effective. However, we invite you to send any written data, views, or arguments about this final rule. Send your comments to an address listed under the ADDRESSES section. Include the docket number FAA-2018-0463 and product identifier 2018-CE-021-AD at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this final rule. We will consider all comments received by the closing date and may amend this final rule because of those comments.

We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this final rule.

We estimate that this AD affects 72 airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

We estimate the following costs to do any necessary replacements that would be required based on the results of the pilot check of the braking system during ground operations before every flight and before every landing. We have no way of determining the number of airplanes that might need these replacements:

Since the addition of airplanes to the Applicability section is based on a typographical error in the manufacturer's service information, all affected airplanes were previously accounted for in the cost estimate of AD 2018-06-10. There is no change to this Cost of Compliance section.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to small airplanes, gliders, balloons, airships, domestic business jet transport airplanes, and associated appliances to the Director of the Policy and Innovation Division.

This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),

(3) Will not affect intrastate aviation in Alaska, and

(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends part 39 of the Federal Aviation Regulations (14 CFR part 39) as follows:

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

The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because it is impracticable. We must establish this special local regulation on May 26, 2018 and lack sufficient time to publish an NPRM, provide a reasonable comment period and then consider those comments before issuing this rule. The NPRM process would delay the establishment of the regulated area until after the date of the swim event and compromise public safety.

For the reason discussed above, under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register.

The Coast Guard is issuing this rule under authority to establish special local regulations in 33 U.S.C. 1231. The Captain of the Port Charleston (COTP) has determined that potential hazards associated with the Low Country Splash Open Swim event presents a safety concern for anyone in the vicinity of the regulated area during the event. This rule is needed to protect participants, spectators, and the general public in the navigable waters within the regulated area during the Low Country Splash Open Swim event.

This rule establishes a special local regulation that will encompass certain waters of the Wando River, Cooper River, and Charleston Harbor during the Low Country Splash Open Swim event. The special local regulation will be enforced from 7 a.m. until 11 a.m. on May 26, 2018. This special local regulation will establish a moving regulated area beginning at Daniel Island Pier, south along the coast of Daniel Island, across the Wando River to Hobcaw Yacht Club, south along the coast of Mt. Pleasant, SC, to Charleston Harbor Resort Marina. Within the regulated area, non-participant persons and vessels are prohibited from entering, transiting through, anchoring in, or remaining within the regulated area without obtaining permission from the COTP Charleston or a designated representative. Persons and vessels may request authorization to enter, transit through, anchor in, or remain within the regulated areas by contacting the COTP Charleston by telephone at (843) 740-7050, or a designated representative via VHF radio on channel 16. If authorization to enter, transit through, anchor in, or remain within the regulated areas is granted by the COTP Charleston or a designated representative, all persons and vessels receiving such authorization must comply with the instructions of the COTP Charleston or a designated representative. The Coast Guard will provide notice of the regulated areas by Local Notice to Mariners, Broadcast Notice to Mariners, or by on-scene designated representatives.

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

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

This regulatory action determination is based on the size, location, duration and time-of-day of the event. Vessel traffic will be able to safely transit around the regulated area during the event, which will impact a small, moving area of the waters of the Wando River, Cooper River, and Charleston Harbor for a period of only four hours. Moreover, the Coast Guard would issue a Broadcast Notice to Mariners via VHF-FM marine channel 16 about the zone, and the rule would allow vessels to seek permission from the COTP or a designated representative to enter, transit through, anchor in, or remain within the zone.

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

While some owners or operators of vessels intending to transit the special local regulation area may be small entities, for the reasons stated in V.A. above, this rule would not have a significant impact on any vessel owner or operator.

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

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

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

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.

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

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

We have analyzed this rule under Department of Homeland Security Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a special local regulation issued in conjunction with a regatta or marine parade that will prohibit persons and vessels from entering, transiting through, anchoring in, or remaining within a moving regulated area on the waters of the Wando River, Cooper River, and Charleston Harbor. It is categorically excluded from further review under paragraph L61 of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES.

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

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 100 as follows:

On July 6, 2017, the Coast Guard published a temporary deviation entitled “Drawbridge Operation Regulation; Jamaica Bay, Queens, NY” in the Federal Register (82 FR 31255). That deviation allowed the bridge to open with two-hours of advance notice from July 6, 2017 to December 22, 2017. On December 7, 2017, the Coast Guard published a temporary interim rule with request for comments entitled “Drawbridge Operation Regulation; Jamaica Bay, Queens, NY” in the Federal Register (82 FR 57674). That temporary interim rule extended the period the bridge may remain in the closed position through May 25, 2018.

The owner of the bridge, the Metropolitan Transportation Authority, requested a second temporary deviation to extend the bridge closure from 12:01 a.m. on May 26, 2018 to 11:59 p.m. on June 29, 2018. This extension is necessary to complete emergency repairs associated with the replacement of lift span machinery that has been delayed by inclement weather.

The Marine Parkway (Gil Hodges) Bridge across Rockaway Inlet, mile 3.0 at Queens, New York is a vertical lift bridge with a vertical clearance of 55 feet at mean high water and 59 feet at mean low water in the closed position. The existing drawbridge operating regulations are listed at 33 CFR 117.795(a).

The waterway is transited by seasonal recreational traffic and some commercial vessels. Coordination with waterway users has indicated no objections to the proposed closure of the draw. Vessels able to pass through the bridge in the closed position may do so at any time. The bridge will not be able to open for emergencies. There is no immediate alternate route for vessels unable to pass through the bridge when in the closed position.

The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessel operators can arrange their transits to minimize any impact caused by this temporary deviation.

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

These safety zones found in 33 CFR 165.1315 will be activated and thus subject to enforcement at least 1 hour before and 1 hour after the duration of the event each day as listed in the following Table:

All coordinates are listed in reference Datum NAD 1983.

In addition to this notice of enforcement in the Federal Register, the Coast Guard plans to provide notification of these enforcement periods via the Local Notice to Mariners.

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

On March 1, 2018, the Coast Guard was notified of fireworks events planned for May 24, 25, 26, and 27, 2018. In response, on May 2, 2018, the Coast Guard published a notice of proposed rulemaking (NPRM) titled Safety Zone; Fireworks, Delaware River, Philadelphia, PA (83 FR 19189). There we stated why we issued the NPRM, and invited comments on our proposed regulatory action related to this fireworks display. During the comment period that ended May 9, 2018, we received no comments.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register. Delaying the effective date of this rule would be impracticable because the safety zone needs to be established prior to May 24, 2018.

The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The COTP Delaware Bay has determined that potential hazards associated with the fireworks to be used in fireworks displays from May 24 through May 27, 2018 will be a safety concern for anyone within the area defined later in this document. The purpose of this rule is to ensure safety of vessels and the navigable waters in the safety zone before, during, and after the scheduled event.

As noted above, we received no comments on our NPRM published May 2, 2018. There are no changes in the regulatory text of this rule from the proposed rule in the NPRM.

This rule establishes a safety zone on the Delaware River adjacent to Penns Landing in Philadelphia, PA, May 24, 2018, through May 27, 2018. The safety zone will be enforced from approximately 8 p.m. to 11 p.m. on nights on which fireworks are being displayed from a barge in the Delaware River. These fireworks displays may be held on May 24th, 25th, 26th, and 27th, or on only some of these dates. Notification of enforcement dates and times will be published in the Coast Guard District 5 Local Notice to Mariners and broadcast via Broadcast Notice to Mariners. The safety zone will include all navigable waters of Delaware River, adjacent to Penns Landing, Philadelphia, PA, bounded from shoreline to shoreline, bounded on the south by a line running east to west from points along the shoreline connecting at latitude 39°56′31.2″ N, longitude 075°08′28.1″ W; thence westward to latitude 39°56′29″.1 N, longitude 075°07′56.5″ W, and bounded on the north by the southern edge of the Benjamin Franklin Bridge where it crosses the Delaware River.

Access to this safety zone will be restricted during the specified enforcement dates and time periods. Vessels may not take on bunkers or conduct lightering operations inside the zone during times of enforcement. Only vessels or persons specifically authorized by the COTP Delaware Bay or designated representative may enter or remain in the regulated area. Requests to enter or remain in the zone will be required to be submitted to the COTP Delaware Bay, or his designated representative via VHF-FM channel 16 or 217-271-4807. Vessels engaged in law enforcement, servicing of aids to navigation, and emergency response will be exempt from these requirements.

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

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

This regulatory action determination is based on the size, location, duration and time of day of the safety zone. The proposed safety zone will impact waters affected by this rule on May 24, 25, 26, and 27, 2018 from 8 p.m. to 11 p.m. During this time of day commercial and recreational traffic is normally low. Notifications of enforcement dates and times will be made to the maritime community via Broadcast Notice to Mariners and Local Notice to Mariners so that plans may be adjusted accordingly. Notifications will be updated as necessary, to keep the maritime community informed of the status of the safety zone.

The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard received no comments from the Small Business Administration on this rulemaking. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

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

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

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

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

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.

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

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

We have analyzed this rule under Department of Homeland Security Directive 023-01 and Commandant Instruction M16475.1D, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone that will only be enforced for a short duration and excludes vessels from entry into or remaining within a specified area on the Delaware River. It is categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES.

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

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

The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(3)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because it would be impracticable. This safety zone must be established by May 25, 2018 and we lack sufficient time to provide a reasonable comment period and then consider those comments before issuing this rule. The NPRM process would delay the establishment of the safety zone until after the scheduled date of the fireworks and compromise public safety.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register. Delaying the effective date of this rule would be impracticable and contrary to the public interest because immediate action is necessary to ensure the safety of vessels, persons, and marine environment during the fireworks display.

The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The Captain of the Port Sector Corpus Christi (COTP) has determined that potential hazards associated with the fireworks display occurring on May 25, 2018 through September 2, 2018 will be a safety concern for anyone within a 1000-foot radius of the fireworks display. This rule is necessary to protect personnel, vessels, and the marine environment before, during, and after the scheduled firework displays.

This rule establishes a safety zone from 8:45 p.m. on May 25, 2018 through 9:45 p.m. on September 2, 2018. It will be enforced from 8:45 p.m. through 9:45 p.m. each day on May 25, 27; June 1, 7, 8, 14, 15, 21, 22, 28, 29; July 4, 5, 6, 12, 13, 19, 20, 26, 27; August 2, 3, 9, 10, 17, 24, 31; and September 2, 2018. The safety zone will cover all navigable waters within 1000 feet of the fireworks barge located in the approximate position 026°06′19″ N, 097°10′55.4″ W, in South Padre Island, TX. The duration of the zone is intended to protect personnel, vessels, and the marine environment before, during, and after the scheduled firework displays.

Entry of vessels or persons into this zone is prohibited unless authorized by the Captain of the Port Sector Corpus Christi (COTP) or a designated representative. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative. A designated representative is a commissioned, warrant, or petty officer of the U.S. Coast Guard assigned to units under the operational control of USCG Sector Corpus Christi. All persons and vessels permitted to enter this safety zone must transit at the slowest safe speed and comply with all lawful directions issued by the COTP or the designated representative. The COTP or a designated representative will inform the public of the enforcement times and date for this safety zone through Broadcast Notices to Mariners (BNMs), Local Notices to Mariners (LNMs), and/or Marine Safety Information Bulletins (MSIBs), as appropriate.

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

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

This regulatory action determination is based on the size, location, duration, and time-of-day of the safety zone. Vessel traffic will be able to safely transit around this safety zone, which will impact a small designated area of Laguna Madre for about 1 hour during evenings when vessel traffic is normally low. Moreover, the Coast Guard will issue a BNMs via VHF-FM marine channel 16 about the zone, and the rule allows vessels to seek permission to enter the zone.

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

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

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

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

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

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.

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

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

We have analyzed this rule under Department of Homeland Security Directive 023-01 and Commandant Instruction M16475.1D, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone lasting one hour that would prohibit entry within 500 feet of the fireworks launch location. It is categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES.

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

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

The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule. Since the Coast Guard received notice of this event on March 26, 2018, notice and comment procedures would be impracticable in this instance.

For similar reasons as those stated above, under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register.

The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The Captain of the Port (COTP) San Francisco has determined that potential hazards associated with the planned fireworks display on May 24, 2018, will be a safety concern for anyone within a 100-foot radius of the fireworks barge and anyone within a 560-foot radius of the fireworks firing site. This rule is needed to protect spectators, vessels, and other property from hazards associated with pyrotechnics.

This rule establishes a temporary safety zone during the loading and transit of the fireworks barge, until after completion of the fireworks display. During the loading of the pyrotechnics onto the fireworks barge, scheduled to take place from 11:00 a.m. to 4:00 p.m. on May 24, 2018, at Pier 50 in San Francisco, CA, the safety zone will encompass the navigable waters around and under the fireworks barge within a radius of 100 feet.

The fireworks barge will remain at Pier 50 until the start of its transit to the display location. Towing of the barge from Pier 50 to the display location is scheduled to take place from 8:00 p.m. to 8:30 p.m. on May 24, 2018, where it will remain until the conclusion of the fireworks display.

At 9:00 p.m. on May 24, 2018, 30 minutes prior to the commencement of the 10-minute fireworks display, the safety zone will increase in size and encompass the navigable waters around and under the fireworks barge within a radius of 560 feet in approximate position 37°46′36″ N, 122°22′56″ W (NAD 83) for the San Francisco State University Graduation Fireworks Display. The safety zone shall terminate at 10:00 p.m. on May 24, 2018.

The effect of the temporary safety zone is to restrict navigation in the vicinity of the fireworks loading, transit, and firing site. Except for persons or vessels authorized by the COTP or the COTP's designated representative, no person or vessel may enter or remain in the restricted areas. These regulations are needed to keep spectators and vessels away from the immediate vicinity of the fireworks firing sites to ensure the safety of participants, spectators, and transiting vessels.

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

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

This regulatory action determination is based on the limited duration and narrowly tailored geographic area of the safety zone. Although this rule restricts access to the waters encompassed by the safety zone, the effect of this rule will not be significant because the local waterway users will be notified via public Broadcast Notice to Mariners to ensure the safety zone will result in minimum impact. The entities most likely to be affected are waterfront facilities, commercial vessels, and pleasure craft engaged in recreational activities.

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

This rule may affect the following entities, some of which may be small entities: Owners and operators of waterfront facilities, commercial vessels, and pleasure craft engaged in recreational activities and sightseeing, if these facilities or vessels are in the vicinity of the safety zone at times when this zone is being enforced. This rule will not have a significant economic impact on a substantial number of small entities for the following reasons: (i) This rule will encompass only a small portion of the waterway for a limited period of time, and (ii) the maritime public will be advised in advance of these safety zones via Broadcast Notice to Mariners.

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

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

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

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.

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

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

We have analyzed this rule under Department of Homeland Security Management Directive 023-01, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves safety zones of limited size and duration. It is categorically excluded from further review under Categorical Exclusion L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES.

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

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

Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA. This supplementary information section is arranged as follows:

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

On March 19, 2018 (83 FR 11944), the EPA proposed to approve the following rule into the California SIP.

We proposed to approve this rule because we determined that it complies with the relevant CAA requirements. Our proposed action contains more information on the rule and our evaluation.

The EPA's proposed action provided a 30-day public comment period. During this period, we received six comments. One comment noted that the rule focuses specifically on “motor vehicle assembly coating operations,” and stated that it should include all components of the car manufacturing process, in order to address issues related to climate change. Rule 1151.1 is intended to control VOC emissions from a specific type of operation, and as such, we believe that the rule is appropriate in scope and stringency. For the reasons addressed in the proposal, the EPA has determined that the rule is consistent with applicable CAA requirements and appropriate for inclusion in the SIP.

The other five comments raised issues outside the scope of this rulemaking, including bird and bat deaths associated with wind turbines and the risks of unmanaged forests and wildfires. None of those comments are germane to our evaluation of Rule 1151.1.

No comments were submitted that changed our assessment of the rule as described in our proposed action. Therefore, as authorized in section 110(k)(3) of the Act, the EPA is fully approving this rule into the California SIP.

In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of the AVAQMD rule described in the amendments to 40 CFR part 52 set forth below. The EPA has made, and will continue to make, these documents available through www.regulations.gov and at the EPA Region IX Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information).

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

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

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

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

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

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

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

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

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

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

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

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

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by July 23, 2018. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

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

Throughout this document wherever “we,” “us,” or “our” is used, it is intended to refer to the EPA.

On February 23, 2018, the EPA proposed to approve Oregon's December 27, 2013, and October 20, 2015, SIP submissions as meeting certain infrastructure requirements of the Clean Air Act for the 2010 nitrogen dioxide (NO2), 2010 sulfur dioxide (SO2), and 2012 fine particulate matter (PM2.5) NAAQS (83 FR 8021). We also proposed to approve, and incorporate by reference, associated rule updates to implement the PM2.5 NAAQS, and an unrelated rule update for the ozone NAAQS, submitted July 18, 2017. Please see our proposed rulemaking for further explanation and the basis for our finding (February 23, 2018, 83 FR 8021).

The public comment period for the EPA's proposed action ended on March 26, 2018. We received 26 electronic comments submitted anonymously through https://www.regulations.gov. We reviewed the comments and we have determined that none are germane to this action. Therefore, we are finalizing our action as proposed.

The EPA is approving Oregon's December 27, 2013, and October 20, 2015, SIP submissions as meeting specific infrastructure requirements of the Clean Air Act. We find that the Oregon SIP meets the following Clean Air Act section 110(a)(2) infrastructure elements for the 2010 NO2, 2010 SO2, and 2012 PM2.5 NAAQS: (A), (B), (C), (D)(i)(II), (D)(ii), (E), (F), (G), (H), (J), (K), (L), and (M).

We are also approving, and incorporating by reference at 40 CFR part 52, subpart MM, the following rule sections:

• OAR 340-202-0060 Suspended Particulate Matter (state effective October 16, 2015); and

• OAR 340-250-0030 Definitions (state effective October 16, 2015); and

• OAR 340-202-0090 Ozone (state effective July 13, 2017).

We note that the approval of OAR 340-202-0090 is unrelated and unnecessary for our infrastructure action. We are including it in this action for efficiency. This action is being taken under section 110 of the Clean Air Act.

In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of Oregon Administrative Rules related to ambient air quality standards described in section II. Final Action, and the amendments to 40 CFR part 52 set forth below. The EPA has made, and will continue to make, these materials generally available through https://www.regulations.gov and at the EPA Region 10 Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information). Therefore, these materials have been approved by the EPA for inclusion in the state implementation plan, have been incorporated by reference by the EPA into that plan, are fully federally enforceable under sections 110 and 113 of the Clean Air Act as of the effective date of the final rulemaking of the EPA's approval, and will be incorporated by reference in the next update to the SIP compilation.1

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

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

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

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

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

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (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 the EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

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

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by July 23, 2018. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2)).

For the reasons set forth in the preamble, 40 CFR part 52 is amended as follows:

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2015-0775 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 July 23, 2018. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2015-0775, by one of the following methods:

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

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

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

In the Federal Register of February 7, 2017 (82 FR 9555) (FRL-9956-86), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 6F8474) by Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, NC 27419. The petition requested to establish tolerances in 40 CFR part 180 for residues of the fungicide pydiflumetofen in or on barley, grain at 4.0 ppm; barley, hay at 30.0 ppm; barley, straw at 30.0 ppm; corn, field, grain at 0.015 ppm; corn, field, forage at 6.0 ppm; corn, field, stover at 15.0 ppm; corn, field, milled by products at 0.06 ppm; corn, pop, grain at 0.015 ppm; corn, pop, forage at 6.0 ppm; corn, pop, stover at 15.0 ppm; corn, sweet, ear at 0.01 ppm; corn, sweet, forage at 5.0 ppm; corn, sweet, stover at 9.0 ppm; corn, sweet, cannery waste at 2.0 ppm; crop subgroup 4-15A, leafy greens subgroup at 40.0 ppm; crop subgroup 22B, leaf petiole vegetable subgroup at 15.0 ppm; fruits, small vine climbing, except fuzzy kiwi subgroup 13-07F at 1.5 ppm; grape, raisin at 2.0 ppm; grape, wet pomace at 1.5 ppm; grain, aspirated fractions at 100.0 ppm; grain, cereal, forage, fodder and straw, group 16 at 50 ppm; oat, grain at 2.0 ppm; oat, forage at 10.0 ppm; oat, hay at 40.0 ppm; oat, straw at 20.0 ppm; peas and bean, dried shelled, except soybean, subgroup 6C at 0.4 ppm; peas, hay at 40.0 ppm; peas, vine at 6.0 ppm; peanut, nutmeat at 0.02 ppm; peanut, refined oil at 0.05 ppm; peanut, hay at 20.0 ppm; potato, wet peel at 0.03 ppm; potato, dried pulp at 0.05 ppm; potato, processed waste at 0.03 ppm; quinoa, grain at 4.0 ppm; rapeseed, subgroup 20A at 0.9 ppm; rye, grain at 4.0 ppm; rye, hay at 50.0 ppm; rye, straw at 30.0 ppm; soybean, seed at 0.4 ppm; soybean, forage at 30.0 ppm; soybean, hay at 150 ppm; tomato, dried pomace at 15.0 ppm; tomato, wet pomace at 1.5 ppm; tomato, sun-dried at 3.0 ppm; vegetables, fruiting, crop group 8-10 at 0.6 ppm; vegetables, tuberous and corm subgroup 1C at 0.015 ppm; vegetables, cucurbit, crop group 9 at 0.5 ppm; wheat, grain at 0.3 ppm; wheat, forage at 15.0 ppm; wheat, hay at 50.0 ppm; and wheat, straw at 30.0 ppm.

Additionally, the petition requested to establish tolerances for residues of pydiflumetofen and 2,4,6-trichlorophenol in or on cattle, fat at 0.03 ppm; cattle, kidney at 0.02 ppm; cattle, liver at 0.04 ppm; cattle, meat at 0.02 ppm; cattle, byproducts at 0.04 ppm; goat, fat at 0.03 ppm; goat, kidney at 0.02 ppm; goat, liver at 0.04 ppm; goat, meat at 0.02 ppm; goat, meat byproducts at 0.04 ppm; horse, fat at 0.03 ppm; horse, kidney at 0.02 ppm; horse, liver at 0.04 ppm; horse, meat at 0.02 ppm; horse, meat byproducts at 0.04 ppm; milk at 0.02 ppm; milk, cream at 0.04 ppm; sheep, fat at 0.03 ppm; sheep, kidney at 0.02 ppm; sheep, liver at 0.04 ppm; sheep, meat at 0.02 ppm; and sheep, meat byproducts at 0.04 ppm. That document referenced a summary of the petition prepared by Syngenta Crop Protection, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

Consistent with the authority in FFDCA section 408(d)(4)(A)(1), EPA is establishing tolerances as requested with some variations. The reasons for these changes are explained in Unit IV.D.

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

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

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

The liver was a common target across species tested, likely in part due to the extensive first pass metabolism of absorbed pydiflumetofen. Liver effects were either concurrent with body weight depression and other target organ toxicity as in rats, or the first symptoms of treatment-related toxicity as in mice and dogs. Liver toxicity commonly manifested as increased liver weight concordant with hepatocyte hypertrophy in all species and was accompanied by increased cholesterol and triglyceride serum levels and a higher incidence of liver masses and eosinophilic foci of cellular alteration in mice and increased serum levels of liver enzymes and triglycerides in dogs. Male mice further exhibited a dose-dependent increase in the incidence of hepatocellular adenomas and carcinomas (accounted for separately and combined) and in the frequency of individual mice exhibiting multiple liver adenomas following chronic exposure. Treatment-related liver tumors were not observed in female mice nor in rats of either sex.

Body weight effects were also observed in rodents in response to treatment. Adult rats experienced depressed body weight following both subchronic (concurrent with liver toxicity) and chronic oral exposure (in isolation) and mice exhibited body weight depression following chronic exposure concurrent with symptoms of liver toxicity. A dose-dependent increase in the incidence and severity of thyroid gland follicular cell hypertrophy was also noted in rats following subchronic dietary exposure at doses greater than or equal to 587 mg/kg/day. In general, short and intermediate duration repeat dose oral exposures were well tolerated by adult rodents and dogs. Rodents were, however, considerably less tolerant of long-term exposure. Liver and body weight effects manifested at doses 25 and 12 times lower in chronic studies as compared to subchronic studies in mice and rats, respectively. A similar progression of toxicity was not evident in dogs.

The database does not support a conclusion that the pesticide is a neurotoxicant. Although a dose-dependent decrease in two locomotor activity parameters, number of rears and total distance traveled, was observed in female adult rats only within 6 hours of exposure following acute gavage oral exposure to doses greater than or equal to 300 mg/kg in the acute neurotoxicity study, there were no neuropathology lesions or consistent evidence of other behavioral changes accompanying the depressed locomotor activity up to acute doses of 2000 mg/kg. Detailed functional observations of rats and dogs following repeat dose dietary exposure did not identify similar changes in locomotor activity or any other behavioral changes indicative of neurotoxicity.

Body weight toxicity was not a unique observation in adults; it was also observed in rat offspring. In the two-generation reproduction study, rat pups exhibited significantly reduced weight during lactation that persisted through weaning and into adulthood. The pup body weight decrements were observed in the absence of parental toxicity indicating post-natal susceptibility to pydiflumetofen exposure. There was no evidence of enhanced fetal susceptibility following gestational exposure to pregnant rats or rabbits in the developmental studies.

Although there is some evidence of carcinogenicity in the database (i.e., hepatocellular adenomas and carcinomas in male mice), the Agency has concluded that pydiflumetofen is not likely to be carcinogenic to humans at doses that do not induce a proliferative response in the liver. This conclusion is based on the limited nature of tumors seen in the available data (liver tumors found only in male mice), the fact that pydiflumetofen is not a mutagenic concern in vivo, and available mode of action data. The available mode of action data supports the Agency's conclusion that liver tumors are likely induced via activation of the constitutive androstane receptor (CAR) and subsequent stimulation of hepatocellular proliferation, and that hepatocellular proliferation is not likely to occur at the doses at which EPA is regulating exposure to pydiflumetofen. As a result, a non-linear approach using the chronic reference dose would adequately account for chronic toxicity, including carcinogenicity.

Pydiflumetofen exhibited low acute toxicity via the dermal and inhalation route. Acute dermal exposure to dermal doses of 5000 mg/kg elicited reduced activity in rats similar to observations following acute oral exposure, but it did not incur mortality. Acute exposure did not irritate the skin nor did it elicit dermal sensitization. No dermal or systemic toxicity was observed following repeat-dose dermal exposures up to 1000 mg/kg/day. Acute lethality from inhalation exposure was limited to high inhalation concentrations and it was a mild acute eye irritant. The requirement for the subchronic inhalation toxicity study was waived for the pydiflumetofen risk assessment based on a weight of evidence (WoE) approach that considered all of the available hazard and exposure information for pydiflumetofen, including: (1) The physical-chemical properties of pydiflumetofen indicated low volatility (vapor pressure is 3.98 x 10−9 mm Hg at 25 °C); (2) the use pattern and exposure scenarios; (3) the margins of exposure for the worst case scenarios are ≥13,000 using an oral point of departure and assuming inhalation and oral absorption are equivalent; (4) pydiflumetofen exhibits low acute inhalation toxicity (Category IV); and (5) the current endpoints selected for risk assessment, liver toxicity and pup body weight decrements, were the most sensitive effects identified in the database and an inhalation study is not likely to identify a lower POD or more sensitive endpoint for risk assessment.

The toxicity of 2,4,6-trichlorophenol—a pydiflumetofen metabolite and residue of concern in livestock commodities—was evaluated based on studies from the open literature that were provided by the registrant, identified in a previous EPA review of 2,4,6-trichlorophenol (https://www.epa.gov/sites/production/files/2016-09/documents/2-4-6-trichlorophenol.pdf) and the Agency for Toxic Substance and Disease Registry (ATSDR) review of chlorophenols (https://www.atsdr.cdc.gov/toxprofiles/tp107.pdf), or retrieved in a search of the literature conducted for this risk assessment. The absorption, distribution, metabolism and elimination (ADME) information available for 2,4,6-trichlorophenol is similar to the ADME profile for pydiflumetofen: Near complete absorption and extensive metabolism followed by rapid excretion without appreciable tissue accumulation. Oral exposure to 2,4,6-trichlorophenol elicited effects in the liver, kidneys, and hematopoietic system as well as body weight depression. Subchronic oral exposure in rats elicited an increase in liver, kidney (males only), and spleen weight, an increase in total protein and albumin serum levels, a moderate to marked increase in splenic hematopoiesis, and an increased incidence of hepatocyte vacuolation. Following chronic dietary exposure, male rats exhibited an increased incidence of leukemias, lymphomas, and nephropathy, and both sexes exhibited an increased incidence of bone marrow hyperplasia, leukocytosis, fatty metamorphosis in the liver, and chronic inflammation of the kidney. Tissue specific toxicity in mice was limited to the liver and manifest as an increased incidence of liver adenomas and carcinomas following chronic exposure. Adult body weight depression was observed in both rodent species. Mortality also occurred with greater frequency in both species at or above the limit dose. The few studies that examined developmental and offspring effects presented equivocal evidence of offspring toxicity following exposure to 2,4,6-trichlorophenol. Prenatal subchronic drinking water exposure in female rats led to a reduction in litter size and perinatal drinking water exposure in rats elicited changes in offspring spleen and liver weight; however, the health of the dams and its potential contribution to the manifestation of the offspring effects was not discussed in this study so it is unclear whether the offspring toxicity is a direct result of exposure or secondary to maternal toxicity. In a separate study, pup body weight decrements were observed in the presence and absence of parental toxicity following subchronic exposure, but the body weight effect was considered a consequence of the larger litter size rather than treatment. In any event, the effects seen in these studies occurred at doses above the endpoints selected for regulation of pydiflumetofen exposure.

These studies illustrate a spectrum of responses to increasing oral 2,4,6-trichlorophenol exposure: Isolated organ weight changes and a reduction in litter size were observed at doses as low as 30 mg/kg/day with adverse effects in the target tissues and significant body weight depression in adult animals manifesting when the oral dose exceeded 200 mg/kg/day. However, the 2,4,6-trichlorophenol doses that elicited the subchronic and chronic toxicity described above were not below the empirical NOAELs established in comparable pydiflumetofen guideline studies (after converting both to millimoles/kg/day) suggesting that direct exposure to 2,4,6-trichlorophenol is not more toxic than direct exposure to pydiflumetofen. Furthermore, direct exposure to 2,4,6-trichlorophenol is anticipated from dietary exposures only and the dietary PODs selected for pydiflumetofen are protective of all adverse effects reported in the 2,4,6-trichlorophenol literature.

The carcinogenic potential of 2,4,6-tricholorophenol was assessed in 1990 by EPA and classified as a B2-probable human carcinogen in accordance with the 1986 cancer classification guidance based on an increased incidence of combined lymphomas and leukemias in male F344 rats and hepatocellular adenomas or carcinomas in male and female mice. Since that evaluation of 2,4,6-trichlorophenol, new literature has been published on the human relevance of leukemias in the F344 rat. The EPA re-evaluated the 2,4,6-trichlorophenol carcinogenicity literature and the broader scientific literature on rodent leukemia to determine if the data supported conducting a separate cancer assessment for 2,4,6-trichlorophenol. The rodent leukemia literature indicated that the leukemia finding in male F344 rats is common for this strain of rat, is highly variable, and lacks a direct human correlate. Although treatment-related, the EPA concluded the leukemia incidence in rats did not support a linear approach to cancer quantification given its questionable relevance to human health risk assessment. Furthermore, the incidence of lymphomas was not remarkable when examined independently from the leukemias and thus not evidence of carcinogenicity in isolation. The liver tumors observed in male and female mice were considered treatment-related; however, the tumors could not be solely attributed to 2,4,6-trichlorophenol exposure because the investigators did not account for known carcinogenic contaminants of commercial 2,4,6-trichlorophenol solutions that may have contributed to the induction of the liver tumors. These carcinogenic contaminants would not be present when 2,4,6-trichlorophenol is formed through metabolism; therefore, these data were not considered strong evidence of carcinogenicity and did not support a linear approach to 2,4,6-trichlorophenol cancer quantification for exposure resulting from pydiflumetofen use. The literature also did not suggest 2,4,6-trichlorophenol was a mutagenic concern in vivo.

Based on the limited evidence of carcinogenicity and mutagenicity for the metabolite, the EPA concluded that using the RfD approach with the chronic dietary POD selected for the pydiflumetofen dietary assessment would be adequate for assessing direct dietary exposure to 2,4,6-trichlorophenol from the proposed pydiflumetofen uses. Because the chronic POD selected for pydiflumetofen is 66 and 165x lower than the 2,4,6-trichlorophenol dose (on a molar basis) that elicited tumors in rats and mice, respectively, this approach will be protective of potential carcinogenicity from exposure to the metabolite. Consequently, a separate cancer dietary assessment for 2,4,6-trichlorophenol is not warranted at this time.

Specific information on the studies received and referenced in this section and the nature of the adverse effects caused by pydiflumetofen and its metabolite 2,4,6-triclorophenol, 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 “Pydiflumetofen. Human Health Risk Assessment for Foliar Uses on Cereals (Wheat, Triticale, Barley, Rye, and Oat), Quinoa, Corn (Field, Pop, and Sweet), Cucurbits Crop Group 9 (Including Greenhouse Use on Cucumber), Fruiting Vegetables Crop Group 8-10, Small Fruit Vine Climbing Subgroup 13-07F (Except Fuzzy Kiwifruit), Peas and Beans Dried Shelled Subgroup 6C, Leafy Greens Subgroup 4-16A, Leaf Petiole Vegetables Subgroup 22B, Peanuts, Rapeseed Subgroup 20A, Soybean, Tuberous and Corm Vegetable Subgroup 1C, Golf Course Turf, and Ornamentals (Including Greenhouse Use” on pages 61-73 in docket ID number EPA-HQ-OPP-2015-0775.

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.

A summary of the toxicological endpoints for pydiflumetofen used for human risk assessment is shown in Table 1 of this unit. Because the Agency concludes that that the pydiflumetofen toxicity database accounts for 2,4,6-trichlorophenol toxicity that would result from exposure to pydiflumetofen, that exposure to the metabolite is not more toxic than direct exposure to pydiflumetofen, and that there is insufficient information to warrant a separate cancer assessment of the metabolite at this time, EPA concludes that the endpoints for pydiflumetofen will be protective of effects from exposure to the metabolite 2,4,6-trichlorophenol.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to pydiflumetofen, EPA considered exposure under the petitioned-for tolerances. EPA assessed dietary exposures from pydiflumetofen in food as follows:

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

Such effects were identified for pydiflumetofen. In estimating acute dietary exposure, EPA used 2003-2008 food consumption data from the US Department of Agriculture's (USDA's) National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in food, EPA assumed tolerance level residues and 100 percent crop treated (PCT).

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used 2003-2008 food consumption data from USDA's NHANES/WWEIA. As to residue levels in food, EPA assumed tolerance level residues and 100 PCT.

iii. Cancer. As discussed in Unit III.A., the Agency has determined that a separate cancer assessment is not necessary for assessing exposure to pydiflumetofen. Because the chronic reference dose (cRfD) is below 10 mg/kg/day, i.e., the lowest dose known to induce hepatocellular proliferation based on available MOA data, the chronic assessment will be protective for assessing direct dietary exposure to pydiflumetofen. Also discussed in Unit II.A. is the Agency's conclusion that a separate cancer assessment is not required for assessing exposure to 2,4,6-trichlorophenol (free and conjugated) and the cRfD will be protective of potential carcinogenic effects.

iv. Anticipated residue and PCT information. EPA did not use anticipated residue or PCT information in the dietary assessment for pydiflumetofen. Tolerance level residues and 100 PCT were assumed for all food commodities.

2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for pydiflumetofen and its degradate SYN545547 in drinking water using a total toxic residues approach. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of pydiflumetofen and degradate SYN545547. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.

Based on the Pesticides Water Calculator (PWC) modeling, the estimated drinking water concentrations (EDWCs) of pydiflumetofen for acute exposures are estimated to be 17 parts per billion (ppb) for surface water and 95 ppb for ground water and for chronic exposures are estimated to be 3.62 ppb for surface water and 93.4 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For the acute dietary risk assessment, the water concentration value of 95 ppb was used to assess the contribution to drinking water.

For the chronic dietary risk assessment, the water concentration of value 93.4 ppb was used to assess the contribution to drinking water.

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

Pydiflumetofen is proposed for the following uses that could result in residential exposures: Golf course turf and ornamentals in greenhouses, nurseries, fields, and outdoor residential landscapes. EPA assessed residential exposure using the following assumptions: Residential handler exposures are not expected since the proposed residential uses require that handlers wear specific clothing (e.g., long-sleeved shirt and long pants; shoes plus socks) and/or personal protective equipment, and the turf and ornamental use labels will indicate that the product is intended for use by professional applicators, while the crop use labels will include the statement “Not for residential use.” As a result, a residential handler assessment was not conducted. There is the potential for residential short-term post-application exposure for individuals exposed as a result of being in an environment that has been previously treated with pydiflumetofen.

The quantitative exposure/risk assessment for residential post-application exposures is based on the short-term dermal exposure from contact with residues on treated golf course turf while golfing for adults, children 6 to less than 11 years old, and children 11 to less than 16 years old, and short-term dermal exposure from post-application activities with treated ornamental plants for adults and for children ages 6 to less than 11. Intermediate-term exposures are not expected.

Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.

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 pydiflumetofen to share a common mechanism of toxicity with any other substances, and although pydiflumetofen metabolizes into 2,4,6-trichlorophenol, this metabolite does not appear to be produced by other registered pesticides. For the purposes of this tolerance action, therefore, EPA has assumed that pydiflumetofen 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 website at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

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

2. Prenatal and postnatal sensitivity. There was no evidence of fetal sensitivity or toxicity in rat and rabbit developmental studies; however, quantitative offspring sensitivity was noted in the 2-generation reproduction study. Pup body weight depression starting on day 4 of lactation and persisting into adulthood was observed at doses that did not elicit an adverse response in the parental rats. Although body weight was depressed in these animals after maturity and during the mating and post-mating period (specifically in males), it was considered evidence of offspring susceptibility because the lower body weight was a result of impaired growth in the pups. Reduced pup weight, reduced litter size, and increased liver and spleen weight in offspring was also noted following prenatal and perinatal exposure to the pydiflumetofen metabolite, 2,4,6-trichlorophenol. PODs were selected for each exposure scenario to be protective of the parent and metabolite offspring toxicity and offspring susceptibility in the risk evaluation.

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 pydiflumetofen is complete.

ii. Regarding neurotoxicity, evidence of behavioral changes in the pydiflumetofen toxicity database was limited to adult rats in the acute neurotoxicity study (ACN). Female rats exhibited depressed locomotor activity in the form of fewer number of rears and less distance traveled following acute exposure to doses of pydiflumetofen >300 mg/kg (3x to 30x higher than the PODs selected for risk assessment). Male rats did not exhibit any symptoms of neurotoxicity following acute exposure up to 2000 mg/kg/day. No evidence of neurotoxicity was observed in the subchronic rat and dog dietary studies that included additional detailed functional observations to identify neurological impairment nor in the routine clinical observations of the chronic studies and the guideline requirement for an subchronic neurotoxicity (SCN) study was waived. The concern for neurotoxicity in sensitive populations is low because the behavioral effects observed in the acute neurotoxicity studies have well-defined NOAEL/LOAELs, the PODs selected for risk assessment are protective of the acute behavioral change observed in females, there were no corresponding neuropathology changes in females exhibiting decreased locomotor activity, and there was no evidence of neurotoxicity following repeat-dose exposure.

iii. There was evidence of quantitative offspring sensitivity in the 2-generation reproduction study; however, as noted in Section D.2., PODs were selected for each exposure scenario to be protective of the offspring susceptibility in the risk evaluation.

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

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

1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to pydiflumetofen will occupy 8.5% of the aPAD at the 95th percentile of exposure for children 3-5 years old, the population group receiving the greatest exposure.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to pydiflumetofen from food and water will utilize 21% of the cPAD for children 3-5 years old, the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of pydiflumetofen is not expected.

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

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

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 400 for adults, 590 for children 6 to less than 11 years old, and 2,500 for children 11 to less than 16 years old. Because EPA's level of concern for pydiflumetofen 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).

Intermediate-term adverse effects were identified; however, pydiflumetofen is not registered for any use patterns that would result in intermediate-term residential exposure. Intermediate-term risk is assessed based on intermediate-term residential exposure plus chronic dietary exposure. Because there is no 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 intermediate-term risk), no further assessment of intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating intermediate-term risk for pydiflumetofen.

5. Aggregate cancer risk for U.S. population. As discussed in Unit III., the Agency has concluded that regulating on the chronic reference dose will be protective of potential carcinogenicity from exposure to pydiflumetofen. Because the chronic risk assessment did not exceed the Agency's level of concern, the Agency concludes there is not an aggregate cancer risk from exposure to pydiflumetofen.

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 pydiflumetofen residues.

Analytical multi-residue method QuEChERS (Quick, Easy, Cheap, Effective, Rugged, and Safe) as described in Eurofins validation study S14-05402 was independently validated in the following crop matrices: lettuce (high water content), wheat grain (high starch content), oil seed rape (high oil content) and coffee bean (difficult commodity). QuEChERS has been proposed as the enforcement analytical method for plant commodities.

The livestock analytical method was derived from the QuEChERS (EN 15662:2009-02) multi-residue method. It is based on extraction and clean-up procedures, and subsequent LC-MS/MS determination.

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

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

The Codex has not established any MRLs for pydiflumetofen at this time.

The applicant requested a few tolerances on commodities that EPA does not consider to be food or feed items (“corn, sweet, cannery waste,” “grape, wet pomace,” “potato, dried pulp,” “tomato, dried pomace,” and “tomato, wet pomace”); therefore, tolerances are unnecessary. With respect to rye grain, the applicant proposed a tolerance based on barley residue data, but the Agency determined that translating the rye grain tolerance from wheat residue data was more appropriate. For the petitioner-proposed tolerances for soybean forage and hay, there is a feeding restriction on the label, which makes these tolerances unnecessary; therefore, the Agency is not establishing tolerances for those two commodities. The pop corn stover tolerance was revised due to only pop corn stover residues used. For the oat grain and peanut hay tolerances, the petitioner included residues from both formulations, whereas EPA assessed the emulsifiable concentrate (EC) and soluble concentrate (SC) separately to determine if there was a formulation difference and set the tolerance at the higher level to cover residues from either formulation.

Although the petitioner requested tolerances for livestock commodities based on the aggregate residues of the parent and metabolite, EPA is establishing tolerances for livestock commodities based only on measuring residues of the parent compound, in order to harmonize tolerances with Canada. EPA is establishing a meat byproduct tolerance, which covers residues found in liver and kidney, instead of separate liver and kidney tolerances since separate tolerances are not needed. A tolerance for Grain, Cereal, Forage, Fodder and Straw, Group 16 was not set since residue data among the representative commodities varied by more than a factor of five; instead, EPA is establishing individual tolerances. The Agency used the Langmuir model to determine the tolerances for livestock tissue and milk. The milk tolerance was raised to harmonize with Canada's MRLs and in effect would cover the expected cream residues. With respect to wheat germ, milled byproducts, and field corn flour, the median concentration factor was used by the Agency which resulted in different tolerances than those proposed by the petitioner. In addition, EPA has modified some of the commodity definitions, and numerical expression of the tolerance values in order to conform to current Agency policy on significant figures.

Therefore, tolerances are established for residues of pydiflumetofen, including its metabolites and degradates, in or on the following commodities. Compliance with the tolerance levels specified below is to be determined by measuring only pydiflumetofen (3-(difluoromethyl)-N-methoxy-1-methyl-N-[1-methyl-2-(2,4,6-trichlorophenyl)ethyl]-1H-pyrazole-4-carboxamide) in or on the commodity: Barley, grain at 4.0 ppm; Barley, hay at 30 ppm; Barley, straw at 30 ppm; Cattle, fat at 0.03 ppm; Cattle, meat at 0.01 ppm; Cattle, meat byproducts at 0.03 ppm; Corn, field, flour at 0.02 ppm; Corn, field, forage at 6.0 ppm; Corn, field, grain at 0.015 ppm; Corn, field, milled byproducts at 0.06 ppm; Corn, field, stover at 15 ppm; Corn, pop, forage at 6.0 ppm; Corn, pop, grain at 0.015 ppm; Corn, pop, stover at 10 ppm; Corn, sweet, forage at 5.0 ppm; Corn, sweet, kernel plus cob with husks removed at 0.01 ppm; Corn, sweet, stover at 9.0 ppm; Fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13-07F at 1.5 ppm; Goat, fat at 0.03 ppm; Goat, meat at 0.01 ppm; Goat, meat byproducts at 0.03 ppm; Grain, aspirated fractions at 100 ppm; Grape, raisin at 2.0 ppm; Horse, fat at 0.03 ppm; Horse, meat at 0.01 ppm; Horse, meat byproducts at 0.03 ppm; Leaf petiole vegetable subgroup 22B at 15 ppm; Leafy greens subgroup 4-16A at 40 ppm; Milk at 0.03 ppm; Oat, forage at 10 ppm; Oat, grain at 3.0 ppm; Oat, hay at 40 ppm; Oat, straw at 20 ppm; Pea, field, forage at 6.0 ppm; Pea, field, hay at 40 ppm; Peanut at 0.02 ppm; Peanut, hay at 30 ppm; Peanut, refined oil at 0.05 ppm; Peas and bean, dried shelled, except soybean, subgroup 6C at 0.40 ppm; Potato, processed potato waste at 0.03 ppm; Potato, wet peel at 0.03 ppm; Quinoa, grain at 4.0 ppm; Rapeseed subgroup 20A at 0.90 ppm; Rye, grain at 0.30 ppm; Rye, hay at 50 ppm; Rye, straw at 30 ppm; Sheep, fat at 0.03 ppm; Sheep, meat at 0.01 ppm; Sheep, meat byproducts at 0.03 ppm; Soybean, seed at 0.40 ppm; Tomato, dried at 3.0 ppm; Vegetable, cucurbit, group 9 at 0.50 ppm; Vegetable, fruiting, group 8-10 at 0.60 ppm; Vegetable, tuberous and corm subgroup 1C at 0.015 ppm; Wheat, forage at 15 ppm; Wheat, germ at 0.40 ppm; Wheat, grain at 0.30 ppm; Wheat, hay at 50 ppm; Wheat, milled byproducts at 2.0 ppm; and Wheat, straw at 30 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), nor is it considered a regulatory action under Executive Order 13771, entitled “Reducing Regulations and Controlling Regulatory Costs” (82 FR 9339, February 3, 2017). 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: