Background

Through strategic grant investments that foster job creation and attract private investment, EDA supports development in economically distressed areas of the United States to prepare these areas for growth and success in the worldwide economy.

EDA is issuing this final rule to update the agency's regulations implementing the TAAF program (Part I) and PWEDA (Part II). The changes will ease the burden on firms and grantees by eliminating unnecessary and duplicative regulations and clarifying and reorganizing the regulations to make them easier to understand.

The updates will also incorporate best practices. For example, EDA is adding a requirement that firms must begin implementation of their Adjustment Proposal (“AP”) within six months after the AP is approved by EDA. Firms that do not begin implementation within six months after approval must update and re-submit their AP, and then request re-approval before any Adjustment Assistance may be provided. EDA is also incorporating changes that will enable firms to amend their APs within two years of EDA approval and that will require firms to complete implementation of the APs within five years of approval. These are existing best practices and help to ensure that APs reflect current conditions and are maximally effective.

The updates will align the regulations more closely with statutory requirements. Specifically, EDA refers to imported articles or services that compete with and are substantially equivalent to the petitioning firm's as “directly competitive or like,” as written in the Trade Act, rather than simply “directly competitive.” In addition, EDA is clarifying all references to “days” as “calendar days,” to reflect this usage in the Trade Act, a change that will also speed up the time within which EDA is required to make determinations regarding firm eligibility and assistance.

On August 19, 2019, EDA published an NPRM in the Federal Register requesting public comments on the general updates and elimination of certain TAAF and PWEDA regulations contained in this final rule (84 FR 42831). The public comment period closed on September 18, 2019. EDA received no comments in response to the NPRM. For this reason, this final rule contains no changes to the rulemaking that was proposed in the NPRM, apart from two technical corrections. The first technical correction changes several instances of “Adjustment Plan” to “Adjustment Proposal.” “Adjustment Plan” is not a defined term; “Adjustment Proposal” is the correct term that should be used throughout. The second technical correction, to revised 13 CFR 315.15, eliminates an improper citation to the Tariff Act and is discussed below in Part I.

Lastly, because this rule will remove certain regulations and will make it easier for firms and EDA grantees to comply with the requirements for the TAAF and EDA grant programs, it is considered a “deregulatory action” pursuant to the April 5, 2017, OMB guidance memorandum implementing Executive Order 13771 (M-17-21).

Authorized under chapter 3 of title II of the Trade Act of 1974 (19 U.S.C. 2341-2355), the TAAF program assists import-impacted U.S. manufacturing firms, oil and natural gas production firms, and service firms with developing and implementing projects to regain global competitiveness, expand markets, strengthen operations, and increase profitability, thereby increasing U.S. jobs.

The TAAF program provides cost-sharing technical assistance to eligible import-impacted U.S. manufacturing firms, oil and natural gas production firms, and service firms in all 50 States, the District of Columbia, and the Commonwealth of Puerto Rico. Technical assistance is provided through a nationwide network of 11 TAACs, which are non-profit or university-affiliated entities.

TAACs provide eligible firms with customized assistance from industry experts knowledgeable about the unique needs, challenges, and opportunities facing industries in their respective regions. Firms work with TAACs to apply for certification of eligibility for TAAF assistance. Firms demonstrate their eligibility by documenting that they have experienced a decline in sales or a decline or impending decline in employment or worker hours, and that an increase of imports of directly competitive goods or services contributed importantly to such declines. EDA then renders a decision regarding the firms' eligibility.

TAACs work closely with eligible firms' management to identify the firms' strengths and weaknesses and then develop customized business recovery plans, APs, which are designed to stimulate recovery and growth. The TAAF program pays up to 75 percent of the costs of developing APs. EDA reviews firms' APs and determines whether or not to approve them. When an AP has been approved, firm management and TAAC staff jointly identify consultants with the specific expertise to help the firm implement the AP. If the cost exceeds the simplified acquisition threshold, consultants are selected through a competitive procurement process.

The discussion that follows presents an overview of substantive changes by subpart letter and section number.

EDA is transferring §§ 315.4 and 315.5 from subpart A to subpart B. This change will retain all general provisions within subpart A, while consolidating the regulations regarding TAAC selection, operation, role, and coverage within subpart B.

EDA is replacing this section with a new programmatic description of TAAF's purpose. The revised section more clearly lays out the process by which EDA executes its responsibilities concerning the TAAF program, as delegated by the Secretary of Commerce, and the process by which firms work with TAACs to request and obtain Adjustment Assistance.

EDA is making changes to the definitions identified below.

EDA is making three revisions to the definition of Adjustment Assistance. First, EDA is removing the reference to “or industries.” As explained further in the discussion of the changes to § 315.17, EDA is eliminating its regulations related to the provision of trade adjustment assistance to industries. EDA has historically not provided separate industry-wide assistance programs because firms within impacted industries have solicited help through TAAF on an individual basis and because there has been no demand for industry-wide assistance. In addition, EDA provides expedited review of petitions and APs from firms within impacted industries. When the U.S. International Trade Commission (“ITC”) makes an injury determination, in accordance with chapter 3 of the Trade Act, EDA provides expedited consideration to petitions by firms in the affected industry, as well as expedited assistance in preparing and processing AP applications to such firms. EDA believes this individualized approach has been effective in facilitating adjustments within both firms and industries. The removal of regulations that reference trade adjustment assistance to industries will help prevent potential confusion regarding the availability of a parallel industry program. In the event that EDA does determine it is appropriate to provide trade adjustment assistance for industries, EDA will promulgate new regulations to implement the program.

Second, EDA is revising the definition to clarify that Adjustment Assistance refers to technical assistance provided by TAACs. The current regulation is ambiguous and could be interpreted such that EDA provides the technical assistance directly, which is not the case. Third, EDA is adding to the definition a statement that EDA determines what type of assistance is provided and adding a list of the types of assistance that this may include: Preparing a firm's petition for certification of eligibility, developing an AP, and implementing an AP.

EDA is revising the definition for Adjustment Proposal, clarifying that the AP is a firm's plan for improving its competitiveness in the marketplace, consistent with the intent of the TAAF program as established in the Trade Act.

EDA is making a minor change to the definition of Decreased Absolutely to add language clarifying that a firm's sales or production must have declined by a minimum of five percent relative to its sales or production during the applicable time period and that the decline is independent of industry or market fluctuations and relative only to the previous performance of the firm unless EDA determines that such limitations would not be consistent with the purposes of the Trade Act.

EDA is revising the defined term Directly Competitive to add the words “or Like” to the end, such that the term will be Directly Competitive or Like. This change will more closely align this term with the terminology of the Trade Act. EDA is further revising this definition by adding language that clarifies the linkage between this definition and the reference to firms that engage in exploring, drilling, or producing oil or natural gas. By adding the phrase “For the purposes of this term,” before the final sentence in this definition, EDA reinforces the requirement in Section 251 of the Trade Act that firms that engage in these types of activities be considered as producing articles that are directly competitive with imported oil and natural gas for the purposes of TAAF eligibility.

EDA is capitalizing the term, “Unjustifiable Benefits,” as referenced in this definition. This change is the result of EDA adding a definition for Unjustifiable Benefits, as described below. EDA is further revising this definition by adding to the sub-definition of Subsidiary, which is included as a category of firm that may be considered jointly with another firm that is requesting Adjustment Assistance pursuant to TAAF in an effort to prevent Unjustifiable Benefits. EDA is qualifying the definition of Subsidiary by adding an explanation that a firm acquired by another firm but which operates independently of the acquiring firm is considered an Independent Subsidiary and may be considered separately from the acquiring firm as eligible for Adjustment Assistance. This change reflects existing practice and addresses a growing trend in petitions requesting Adjustment Assistance for firms that have been acquired by another firm but continue to operate independently after the acquisition, generally retaining the same management, maintaining control over management decisions, and otherwise continuing operations without significant change.

EDA is modifying this definition by moving the second sentence of this definition to the revised subpart C (Certification of firms) as a new paragraph (c) in § 315.6 (Certification Requirements). EDA believes this sentence is more appropriately located in subpart C as a description of one method for a firm to demonstrate that it meets the eligibility requirements for Certification to apply for Adjustment Assistance. The sentence provides that a firm may submit certifications from a firm's customers that account for a significant percentage of the firm's decrease in sales or production, that the customers increased their purchase of imports of Directly Competitive or Like Articles or Services from a foreign country.

EDA is changing the definition of Partial Separation by replacing language denoting that this definition is with respect to any employment in a firm with language which clarifies that a Partial Separation occurs when there has been no increase in overall employment at the firm and either of the conditions currently described in this definition exist: (1) A reduction in an employee's work hours to 80 percent or less of the employee's average weekly hours during the year of such reductions as compared to the preceding year; or (2) a reduction in the employee's weekly wage to 80 percent or less of his/her average weekly wage during the year of such reduction as compared to the preceding year. EDA occasionally receives petitions submitted by firms whose overall employment figures have increased within the periods of time in question and which, nonetheless, assert that there has been a Partial Separation with regards to a certain portion of their workforce's work hours or weekly wages. EDA believes that this revision should resolve the apparent confusion caused by the current wording and clarify that a firm does not meet the eligibility criteria if its overall employment has increased during the relevant time period.

EDA is revising the definition of Service Sector Firm to remove the last two sentences of the definition because they are already included in the definition of firm.

EDA is streamlining and clarifying the definition of Total Separation by removing the phrase “with respect to any employment in a firm” and adding the words “in a firm” after “the laying off or termination of employment of an employee.”

As noted above, EDA is also adding a definition for Unjustifiable Benefits. Under this new definition, Unjustifiable Benefits describe Adjustment Assistance inappropriately accruing to the benefit of (1) other firms that would not otherwise be eligible when provided to a firm or (2) any predecessor or successor firm, or any affiliated firm controlled or substantially beneficially owned by substantially the same person, rather than treating these entities as a single firm. EDA believes that this is an important concept that should be fully explained to help firms understand TAAF eligibility requirements.

EDA is not changing this section.

EDA is revising this subpart to consolidate and clarify all regulations regarding TAAC selection, operations, and coverage. The revised subpart B, entitled “TAAC Provisions,” would be inserted after § 315.3 and would include revised §§ 315.4 and 315.5, which would be transferred to subpart B from subpart A.

EDA is revising paragraph (a) of this section to better describe the TAAC selection process.

EDA is revising paragraph (b) of this section to replace the existing language with an explanation that TAACs are awarded cooperative agreements that are subject to all Federal laws and to Federal, Department, and EDA policies, regulations, and procedures applicable to Federal financial assistance awards, including 2 CFR part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards, and that TAACs work closely with EDA and import-impacted firms.

EDA is re-designating paragraph (a)(1) as paragraph (a) and, in that same paragraph, revising the third sentence in order to clarify that information regarding all of the TAACs' service areas, rather than just particular geographic areas, are available at the websites listed in that section.

EDA is re-designating paragraphs (a)(2) and (3) as paragraphs (b) and (c), respectively. EDA is also streamlining newly re-designated paragraph (c) by renumbering paragraphs (i) and (ii) as (1) and (2), respectively, and by rewording newly re-designated paragraphs (c)(1) and (2) to provide enhanced clarity on the types of Adjustment Assistance a TAAC may provide to a firm.

EDA is removing existing paragraphs (b), (c), and (d) in their entirety. EDA believes these paragraphs are unnecessary, as these provisions and requirements will generally be covered in the Notice of Funding Opportunity used to announce the availability of funding for TAAC awards.

EDA is revising subpart C to consolidate all regulations regarding the certification of firms. The revised subpart C will include §§ 315.6 through 315.10.

EDA is moving the matching share requirements for APs as set forth in current paragraph (c)(2) to the new § 315.11 (“Adjustment Proposal Process”) in subpart D (“Adjustment Proposals”). EDA is eliminating the remaining requirements in § 315.6, which are duplicative of other regulations in this part and provide no additional guidance or clarity to TAACs or firms. Finally, EDA is re-designating the current § 315.7 as § 315.6.

In addition to these revisions, as noted above in the discussion regarding revisions to the definition of Increase in Imports at § 315.2, EDA is adding a new paragraph (c) to revised § 315.6 and moving into this paragraph the language formerly located in the definition of Increase in Imports that enabled firms to help demonstrate that they meet the eligibility requirements for Adjustment Assistance by submitting certification from the firm's customers that account for a significant percentage of the firms' decrease in sales or production, that the customers increased their purchase of imports of Directly Competitive or Like Articles or Services from a foreign country. EDA is further adding to this new paragraph (c) a sentence specifying that such certification from a firm's customer must be submitted directly to a TAAC or to EDA. EDA believes this addition will ease some confusion by firms, some of which have requested their customers to provide such certification directly to the firms which subsequently pass on the certifications to EDA through the TAACs.

EDA is re-designating the current § 315.8 as § 315.7.

EDA is revising paragraph (b)(5) to clarify the additional requirements for publicly-owned corporations when submitting financial information as part of their petitions for certification. EDA is revising the paragraph to clarify that publicly-owned corporations should submit copies of the most recent Form 10-K annual reports (or Form 10-Q quarterly reports, as appropriate) filed with the U.S. Securities and Exchange Commission for the entire period covered by the petition.

EDA is also revising paragraph (b)(6) to make clear the information required regarding a firm's customers. Specifically, EDA is replacing the qualifier that the description relates to the “major” customers of the firm with one that identifies the customers as “accounting for a significant percent of the firm's decline.” EDA is further revising this paragraph to clarify that firms should submit information regarding those customers' purchases or the firm's unsuccessful bids if there are no customers fitting the description outlined in this paragraph.

EDA is revising paragraph (f) to clarify that, in order to withdraw a petition for certification, the petitioner must submit a request for withdrawal before EDA makes a determination regarding approval or denial of the certification.

EDA is revising paragraphs (g)(1) and (2) of this section. EDA is revising paragraph (g)(1) in order to make clear that EDA may request additional material from a firm beyond what was submitted with the firm's original petition if necessary to make a determination regarding the firm's eligibility for Adjustment Assistance. In addition, EDA is revising paragraph (g)(1) to insert the word “calendar” before the word “days.” EDA is also making similar revisions to all references to “days” found throughout part 315. EDA is making these changes to clarify that all references to “days” within part 315 refer to calendar days as the current regulations are not clear on whether these references to “days” are calendar or business days. EDA is revising paragraph (g)(2) to clarify that firms may not resubmit a petition within one year from the date of a denial without a waiver from EDA issued for good cause.

EDA is re-designating the current § 315.9 as § 315.8.

For the reasons discussed above, EDA is inserting the word “calendar” in front of the word “days” in the introductory paragraph to this section.

EDA is revising paragraph (b)(2) to clarify that, when someone other than the petitioner requests a public hearing on an accepted petition, the requester must include a statement describing the nature of the requester's interest in the proceedings.

EDA is also revising paragraph (d) of this section to clarify that EDA will publish a notice of a public hearing in the Federal Register only if EDA has made the determination that the requesting party has a substantial interest in the hearing.

EDA is re-designating the current § 315.10 as § 315.9.

EDA is also revising paragraphs (a), (b), and (d) to replace the word “Failure” at the beginning of each of those paragraphs with the words “The firm failed” to provide clarity regarding which entity's omission triggers the loss of benefits. EDA is further revising paragraph (d) to read: “The firm failed to diligently pursue an approved Adjustment Proposal, and five years have elapsed since the date of certification.”

EDA is re-designating the current § 315.11 as § 315.10.

EDA is revising paragraphs (a) and (b) of this section by inserting the word “calendar” before the word “days” for the reasons mentioned above.

EDA is removing the designation of paragraph (d) and adding the sentence that formerly stood alone as paragraph (d) to the end of paragraph (c) in this same section. EDA believes this reorganization will reduce potential confusion by placing all requirements regarding the steps EDA takes when it terminates a certification in a single paragraph.

EDA is not changing the designation or heading of this subpart. However, EDA is revising this subpart to include §§ 315.11 and 315.12.

Section 315.11 will be revised to combine requirements currently contained in other sections of part 315 and add new language to reflect best practices. The section heading will be revised to “Adjustment Proposal Process.”

EDA is moving paragraphs (a)(2) and (3) from the current § 315.6 to the revised § 315.11 as paragraphs (a) and (b) within this section in order to consolidate AP procedures within a single section. In order to more clearly reflect the requirements of the Trade Act, EDA is moving the requirement established in the current § 315.16(a), which says APs must be submitted to EDA for approval within two years after the date of Certification, to the new § 315.11(a).

In addition to moving the requirements that currently exist in § 315.6(a)(3) to the revised § 315.11(b), EDA is adding language to these requirements that will require firms to begin implementation of their approved AP within six months after approval. EDA is also adding a requirement that firms that do not begin implementation within six months after approval must update and re-submit their AP for re-approval before any Adjustment Assistance may be provided. These additions reflect long-standing practice and will help firms to ensure that their APs reflect the most up-to-date economic conditions and financial situation and, consequently, that the firms will receive the most effective Adjustment Assistance.

EDA is adding a paragraph (c) to this section that discusses how EDA will make a determination regarding an AP no later than 60 calendar days after receipt of the AP, which incorporates the requirement from Section 252(b)(2) of the Trade Act.

EDA is also adding a paragraph (d) to this section. EDA is moving the matching share requirements for Adjustment Assistance from the existing § 315.6(b)(2) to this paragraph. In addition, EDA is adding a sentence stating that certified firms may request no more than the amount established by EDA for total Adjustment Assistance over the entire lifetime of the firm. This addition incorporates current practice, established to ensure that the maximum number of eligible firms are able to receive Adjustment Assistance and to encourage certified firms to appropriately plan and implement their Adjustment Proposals within established funding limits.

EDA is adding a paragraph (e) to this section and specifying within this paragraph that firms may request EDA approval to amend their APs within two years from the date of EDA approval of their initial APs. This new language incorporates current practice and allows firms to update their APs as needed within the two-year time frame to address any unexpected changes in their situation, new information, or a need to re-direct resources to areas of greatest need.

EDA is also adding a paragraph (f) to this section. Paragraph (f) requires firms to complete implementation of their APs within five years of EDA approval of their initial APs. This added language reflects current practice and EDA's expectation that firms who request Adjustment Assistance are financially and operationally prepared to engage in the TAAF program and will implement their AP in a timely way.

EDA is adding a paragraph (g) to this section to address what occurs if a certified firm is transferred, sold, or otherwise acquired by another firm during the five-year period established in paragraph (f). Paragraph (g) requires a certified firm that is transferred, sold, or otherwise acquired by another firm during the five-year period of Adjustment Assistance to notify EDA no later than 30 calendar days following the transfer, sale, or acquisition. EDA will then make a determination as to whether the firm remains eligible for Adjustment Assistance. This new language incorporates current practice and is designed to resolve any confusion about how firms and TAACs should handle this scenario.

Finally, EDA is adding a paragraph (h) to this section. Paragraph (h) will require firms that receive Adjustment Assistance to provide data regarding the firms' sales, employment, and productivity upon completion of the program and each year for the two-year period following completion. This language incorporates into the regulations reporting requirements established in Section 255A of the Trade Act, which requires EDA to report annually to Congress on data regarding the TAAF program for the preceding fiscal year.

EDA is re-designating the current § 315.16 as § 315.12. As discussed above, EDA is eliminating paragraph (a) of this section after moving the requirement that firms must submit their APs to EDA within two years of the date of certification to § 315.11(a).

EDA is eliminating the current § 315.12 (Recordkeeping). With the proposed revisions to § 315.4(b), which states that TAAC cooperative agreements are subject to all Federal laws and to Federal, Department, and EDA policies, regulations, and procedures applicable to Federal financial assistance awards, including 2 CFR part 200, the current § 315.12 is no longer needed as recordkeeping requirements are adequately addressed in those materials.

EDA is revising the heading for this subpart to “Protective Provisions.” As revised, subpart E will include §§ 315.13 and 315.14. EDA is moving the requirements regarding persons engaged by firms to expedite petitions and APs as found in the current § 315.14 (Certifications) and the requirements regarding conflicts of interest that are contained the current § 315.15 (Conflicts of interest), both of which are found in the current subpart C, to subpart E. EDA believes this reorganization and new location will make it easier for firms to read and understand the regulations and will help clarify that these provisions apply to firms at all stages of the TAAF program.

EDA is moving the requirements for firms to certify in writing to EDA the names of any attorneys, agents, and other Persons engaged by or on behalf of the firm for the purpose of expediting Petitions for Adjustment Assistance and the fees paid or to be paid to any such Person, as found in the current § 315.14, to § 315.13. EDA is further revising these requirements by clarifying, in paragraph (a), that they apply to both Adjustment Assistance and APs.

EDA is eliminating the current § 315.13 (Audit and examination). With the proposed revisions to § 315.4(b), which states that TAAC cooperative agreements are subject to all Federal laws and to Federal, Department, and EDA policies, regulations, and procedures applicable to Federal financial assistance awards, including 2 CFR part 200, the current § 315.13 is no longer needed as audit and examination requirements are adequately addressed in those materials.

EDA is moving the requirements found in the current § 315.15 to § 315.14. EDA is also revising these requirements by modifying the list of firm representatives subject to the conflicts of interest requirements to parallel the list of firm representatives identified in the revised § 315.13.

EDA is adding subpart F, entitled “International Trade Commission Investigations.” Subpart F sets forth, through § 315.15, what actions EDA takes when the ITC makes an affirmative finding under section 202(b) of the Trade Act regarding injury or threat of injury to an industry.

EDA is re-designating the current § 315.17 as § 315.15 and is revising the heading of this section to “Affirmative Findings.” EDA is also removing the designation “(a)” from the first paragraph of this section and eliminating paragraphs (b) and (c) to reflect the fact that EDA, historically, has not provided Adjustment Assistance for the establishment of industry-wide programs for new product development, export development, or other uses consistent with the purposes of the Trade Act because there has been no demand for such programs. As noted above in the discussion regarding changes to the definition of Adjustment Assistance in § 315.2, firms within impacted industries have sought Adjustment Assistance through TAAF on an individual basis rather than through industry-wide solutions. EDA also provides expedited review of petitions and APs from firms within industries for which the ITC has determined that increased imports are a substantial cause of serious injury or threat thereof under section 202(b) of the Trade Act. This individualized approach enables EDA to support adjustments at the firm level, while having a cumulative impact at the industry level.

EDA is replacing within this paragraph the language stating that EDA will provide to firms in the identified industry assistance in the preparation and processing of petitions and applications for benefits; EDA instead will include language establishing notification to TAACs and expedited review of petitions and APs from firms within the specified industry. EDA believes these revisions more clearly describe the assistance EDA provides to industries in response to determinations made by the ITC under the Trade Act.

This revised section contains one technical correction to the proposed revision in the NPRM published in the Federal Register on August 19, 2019 (84 FR 42831). The correction is to eliminate an improper citation to the Tariff Act. The proposed revision to this section provided that EDA would notify TAACs and provide expedited review of petitions and APs from Firms within an industry for which the ITC has made an affirmative finding under section 202(b) of the Trade Act or under sections 705 or 735 of the Tariff Act. Determinations made under section 202(b) of the Trade Act concern serious injury or threat thereof to a domestic injury, while determinations made under sections 705 or 735 of the Tariff Act concern lesser material injury or threat thereof to a domestic industry. Pursuant to section 202(g) of the Trade Act, EDA is only required to provide expedited review of petitions submitted by firms in industries for which the ITC has made an affirmative determination under section 202(b) of the Trade Act.

PWEDA is EDA's organic authority and the primary legal authority under which EDA awards grants. Other legal authorities include the Trade Act and the Stevenson-Wydler Technology Innovation Act of 1980. Under PWEDA, EDA provides financial assistance to both rural and urban distressed communities by fostering entrepreneurship, innovation, and productivity through investments in infrastructure development, capacity building, and business development in order to attract private capital investments and new and better jobs to regions experiencing substantial and persistent economic distress.

EDA is eliminating certain provisions within part 302 of the PWEDA regulations that are unnecessary or already established in other regulations or award documentation. Specifically, EDA is eliminating the regulations located at 13 CFR 302.4, 302.5, and 302.14. These regulations describe: The responsibilities of EDA grant recipients to maintain records, how information supplied to EDA may be subject to public release under the Freedom of Information Act or Privacy Act, how government auditors may need access to various records, and that grant recipients are subject to the government-wide relocation assistance and land acquisition policies. These regulations can be removed because notice of these terms and conditions is already provided to grant recipients through other Department of Commerce-wide or government-wide regulations as well as in specific documentation EDA provides to each grant recipient. Specifically, recipients of EDA financial assistance are already subject to the requirements related to the Freedom of Information Act or Privacy Act currently described in § 302.4 through 15 CFR part 4 and the Standard Terms and Conditions of an EDA award. Similarly, the relocation and land acquisition policies currently found in § 302.5 are already applicable to all EDA financial assistance recipients under government-wide regulations found at 49 CFR part 24. Finally, the record-keeping requirements currently located in § 302.14 duplicate the requirements of Section 608 of PWEDA (42 U.S.C. 3218), 2 CFR 200.333 and 200.336, and the Standard Terms and Conditions of an EDA award.

In addition, EDA is eliminating 13 CFR 302.11. Beginning with the enactment of the original section 502 of PWEDA (42 U.S.C. 3192) in 1998, Congress has required EDA to maintain an economic development information clearinghouse on matters related to economic development, economic adjustment, disaster recovery, defense conversion, and trade adjustment programs and activities. See Public Law 105-393. With the EDA Reauthorization Act of 2004 (Pub. L. 108-373 (Oct. 27, 2004)), Congress amended section 502 to require EDA to, among other things, maintain this information clearinghouse online. The current regulation adds nothing of value to the requirements already in place under section 502 and consequently should be eliminated.

Prior notice and opportunity for public comment are not required for rules concerning public property, loans, grants, benefits, and contracts (5 U.S.C. 553(a)(2)). EDA's programs, including the TAAF program, are financial assistance programs provided through grants and cooperative agreements. As such, prior notice and an opportunity for public comment are not required pursuant to 5 U.S.C. 553, or any other law, and the analytical requirements of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) are inapplicable. Although EDA did choose to publish an NPRM in the Federal Register requesting public comments on the content of this final rule (84 FR 42831), EDA received no comments in response to the NPRM, and thus has received no input from the public bearing on the analytical requirements of the Regulatory Flexibility Act. For these reasons, a regulatory flexibility analysis has not been prepared.

This final rule was drafted in accordance with Executive Orders 12866, 13563, and 13771. The Office of Management and Budget (“OMB”) has determined that this final rule is not significant for purposes of Executive Order 12866 and Executive Order 13563.

This rule is a deregulatory action that has a neutral effect on the costs to firms, organizations, and all other stakeholders to comply with the regulations discussed in this notice of final rule. It is therefore considered to have a total incremental cost of zero pursuant to the April 5, 2017, OMB guidance memorandum implementing Executive Order 13771 (M-17-21).

This final rule is not major under the Congressional Review Act (5 U.S.C. 801 et seq. ).

Executive Order 13132 requires agencies to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in Executive Order 13132 to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule does not contain policies that have federalism implications.

The Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ) (“PRA”) requires that a Federal agency consider the impact of paperwork and other information collection burdens imposed on the public and, under the provisions of PRA section 3507(d), obtain approval from OMB for each collection of information it conducts, sponsors, or requires through regulations. Notwithstanding any other provision of law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with a collection of information subject to the PRA unless that collection displays a currently valid OMB Control Number.

The following table provides the only collections of information (and corresponding OMB Control Numbers) set forth in this final rule. These collections of information are necessary for the proper performance and functions of EDA. This final rule does not include a new information collection requirement and will, thus, use previously approved information collections to collect information relevant to a petition for certification of eligibility for trade adjustment assistance or an AP.

For the reasons discussed above, EDA is amending 13 CFR chapter III as follows:

The EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2019-0122, dated June 4, 2019 (“EASA AD 2019-0122”) (also referred to as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Airbus SAS Model A318 airplanes; Model A319-111, -112, -113, -114, -115, -131, -132, and -133 airplanes; A320-211, -212, -214, -216, -231, -232, and -233 airplanes; and Model A321-111, -112, -131, -211, -212, -213, -231, and -232 airplanes. Model A320-215 airplanes are not certified by the FAA and are not included on the U.S. type certificate data sheet; this AD therefore does not include those airplanes in the applicability.

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2014-24-07, Amendment 39-18040 (79 FR 72124, December 5, 2014) (“AD 2014-24-07”). AD 2014-24-07 applied to certain Airbus SAS Model A318 series airplanes; Model A319-111, -112, -113, -114, -115, -131, -132, and -133 airplanes; A320-211, -212, -214, -231, -232, and -233 airplanes; and Model A321-111, -112, -131, -211, -212, -213, -231, -232 airplanes. The NPRM published in the Federal Register on September 6, 2019 (84 FR 46900). The NPRM was prompted by a report of a crack found in the side box beam flange of the fuselage at the FR 43 level during a fatigue test campaign. The NPRM proposed to continue to require repetitive rototest inspections for cracking; corrective actions if necessary; and modification of the torsion box, which would terminate the repetitive inspections. The NPRM also proposed to require certain revised compliance times. The FAA is issuing this AD to address cracking in the side box beam flange of the fuselage, which could affect the structural integrity of the airplane.

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

United Airlines stated its support for the NPRM.

JetBlue requested that Airbus Service Bulletin A320-53-1251, Revision 03, dated September 19, 2016, and not Airbus Service Bulletin A320-53-1251, Revision 04, dated May 17, 2019, be used for accomplishing the actions specified in the proposed AD and paragraphs (2) and (3) of EASA AD 2019-0122. JetBlue stated that Airbus Service Bulletin A320-53-1251, Revision 04, dated May 17, 2019, does not require any additional work compared to Airbus Service Bulletin A320-53-1251, Revision 03, dated September 19, 2016.

The FAA disagrees with the commenter's request. Paragraph (2) of EASA AD 2019-0122 specifically requires compliance in accordance with Airbus Service Bulletin A320-53-1251, Revision 04, dated May 17, 2019, due to changes highlighted in the Accomplishment Instructions for certain configurations. However, paragraph (5) of EASA AD 2019-0122 provides credit for Airbus Service Bulletin A320-53-1251, dated November 16, 2012; Airbus Service Bulletin A320-53-1251, Revision 01, dated October 18, 2013; Airbus Service Bulletin A320-53-1251, Revision 02, dated February 11, 2016; and Airbus Service Bulletin A320-53-1251, Revision 03, dated September 19, 2016; if the actions are accomplished before the effective date of the AD. This AD provides the same allowance for credit since EASA AD 2019-0122 is incorporated by reference. This AD has not been changed in this regard.

Delta Airlines (DAL) requested that certain language be added to the applicability paragraph of the proposed AD. DAL stated that paragraph (c) of the proposed AD applies to certain Model A310, A320, and A321 family airplanes as identified in EASA AD 2019-0122. DAL stated that EASA AD 2019-0122 provides additional applicability details, namely exclusions of manufacturer serial numbers based upon a certain Airbus modification embodied in production. DAL suggested that similar language be added to paragraph (c) of the proposed AD.

The FAA agrees to clarify the applicability of this AD. By incorporation by reference of EASA AD 2019-0122 into this AD, the same production modification applicability exceptions identified in EASA AD 2019-0122 apply to this AD. These exceptions are addressed by the statement “. . . as identified in European Aviation Safety Agency (EASA) AD 2019-0122” in paragraph (c) of this AD. We have not changed this AD in this regard.

In addition, this AD and EASA AD 2019-0122 are not applicable to Model A310 airplanes as the commenter stated. This AD has not been changed in this regard.

The FAA reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this final rule as proposed, except for minor editorial changes. The FAA has determined that these minor changes:

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

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

EASA AD 2019-0122 describes procedures for repetitive rototest inspections for cracking; corrective actions if necessary; and modification of the torsion box, which terminates the repetitive inspections. This material 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.

The FAA estimates that this AD affects 851 airplanes of U.S. registry. The FAA estimates the following costs to comply with this AD:

The new requirements of this AD add no new economic burden.

The FAA has received no definitive data that would enable the agency to provide cost estimates for the on-condition actions specified in this AD.

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.

The FAA is 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 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) Will not affect intrastate aviation in Alaska, and

(3) 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:

On January 17, 2020, the FAA issued Emergency AD 2020-01-55, which requires the removal from service of the interstage seal, part number 2505M72P01 or 2448M33P01, from certain serial-numbered GE90-110B1 and GE90-115B model turbofan engines. That emergency AD was sent previously to all known U.S. owners and operators of these affected engines. That action was prompted by investigative findings of an event that occurred on October 20, 2019, in which a Boeing Model 777-300ER airplane, powered by GE GE90-115B model turbofan engines, experienced an uncontained HPT failure resulting in an aborted takeoff. This condition, if not addressed, could result in uncontained HPT failure, release of high-energy debris, damage to the engine, damage to the airplane, and possible loss of the airplane.

The FAA is 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 the removal from service of the interstage seal, part number 2505M72P01 or 2448M33P01, from the affected engines.

The FAA considers this AD interim action. The root cause of the HPT failure is still being investigated and the FAA will consider further rulemaking depending on the results of the investigation.

An unsafe condition exists that required the immediate adoption of Emergency AD 2020-01-55, issued on January 17, 2020, to all known U.S. owners and operators of these engines. The FAA found that the risk to the flying public justified waiving notice and comment prior to adoption of this rule because the interstage seal must be removed within 5 flight cycles from the effective date of AD 2020-01-55. Therefore, the FAA finds good cause that notice and opportunity for prior public comment are impracticable. Additionally, the FAA has found the risk to the flying public justifies waiving notice and comment prior to adoption of this rule because no domestic operators use this product. It is unlikely that the FAA will receive any adverse comments or useful information about this AD from U.S. operators. Therefore, the FAA finds good cause that notice and opportunity for prior public comment are unnecessary. These conditions still exist and the AD is hereby published in the Federal Register as an amendment to section 39.13 of the Federal Aviation Regulations (14 CFR 39.13) to make it effective to all persons. For the reasons stated above, the FAA finds 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 was not preceded by notice and an opportunity for public comment. However, the FAA invites 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-2020-0063 and Product Identifier 2020-NE-01-AD at the beginning of your comments. The FAA specifically invites comments on the overall regulatory, economic, environmental, and energy aspects of this final rule. The FAA will consider all comments received by the closing date and may amend this final rule because of those comments.

Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to https://www.regulations.gov, including any personal information you provide. The FAA will also post a report summarizing each substantive verbal contact received about this AD.

Confidential Business Information (CBI) is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this AD contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this AD, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this AD. Submissions containing CBI should be sent to Matthew Smith, Aerospace Engineer, ECO Branch, FAA, 1200 District Avenue, Burlington, MA, 01803. Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.

The FAA estimates that this AD affects 0 engines installed on airplanes of U.S. registry.

The FAA estimates the following costs to comply with this AD:

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.

The FAA is 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 engines, propellers, and associated appliances to the Manager, Engine and Propeller Standards Branch, 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, and

(2) Will not affect intrastate aviation in Alaska.

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

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would amend Class D and establish Class E airspace at Buchanan Field, Concord, CA, to ensure the safety and management of Instrument Flight Rules (IFR) operations at the airport.

The FAA published a notice of proposed rulemaking in the Federal Register (84 FR 56390; October 22, 2019) for Docket No. FAA-2019-0678 to amend Class D and Class E airspace at Buchanan Field, Concord, CA. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. Seven comments were received.

Three comments contained only the Docket number, the airspace docket number and the FAA's RIN number with no additional text or comment.

Two comments questioned why the airspace is being established, since the San Francisco Sectional already appears to contain the proposed airspace within an existing Class E airspace area extending upward from 700 feet above the surface. This new airspace area is being established for Buchanan Field to ensure the airport has independent Class E airspace to contain arriving IFR aircraft when descending below 1,500 feet above the surface. Additionally, one commenter stated that they could not find the proposed Class E area in FAA Order 7400.11D. This action establishes the Class E airspace for the airport and the airspace will be published in the next iteration of FAA Order 7400.11 which will be effective September 15, 2020.

One comment asked how this change would affect local pilot's knowledge of the local area. This change will be charted on subsequent editions of the San Francisco Sectional. This respondent also asked about ADSB equipage and access to airports in the area, below the SFO Class B veil. This airspace action does not impact the equipment requirements for aircraft operations within a Class B veil.

One comment discussed IFR operations and airspace but did not provide a specific concern or support for the proposal.

Class D and Class E5 airspace designations are published in paragraphs 5000 and 6005, respectively, of FAA Order 7400.11D, dated August 8, 2019, and effective September 15, 2019, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.

This document amends FAA Order 7400.11D, Airspace Designations and Reporting Points, dated August 8, 2019, and effective September 15, 2019. FAA Order 7400.11D is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11D lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

This amendment to Title 14 Code of Federal Regulations (14 CFR) part 71 modifies Class D airspace at Buchanan Field extending upward from the surface to and including 2,500 feet MSL within a 2.6-mile radius of the airport from the 205° bearing from the airport clockwise to the 314° bearing, thence extending to a 4.1-mile radius of airport from the 314° bearing from the airport clockwise to the 205° bearing of Buchanan Field. This Class D airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Chart Supplement.

Additionally, this action establishes Class E5 airspace extending upward from 700 feet above the surface within a 4.1-mile radius of Buchanan Field and within 2.5 miles each side of the 009° bearing from the airport extending from the 4.1-mile radius to 11 miles north of the airport, and within 2.5 miles each side of the 023° bearing from the airport extending from the 4.1-mile radius to 11 miles northeast of Buchanan Field.

Further, this action removes the Concord VOR/DME and the associated extensions from the legal description to simplify how the airspace is described.

Lastly, this action removes the city listed before the airport name in the legal description header information to comply with airspace policy guidance.

Class D and Class E5 airspace designations are published in paragraphs 5000, and 6005, respectively, of FAA Order 7400.11D, dated August 8, 2019, and effective September 15, 2019, which is incorporated by reference in 14 CFR 71.1. The Class D and Class E airspace designations listed in this document will be published subsequently in the Order. FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, would not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

The Convention on Cultural Property Implementation Act, Public Law 97-446, 19 U.S.C. 2601 et seq. (“the Cultural Property Implementation Act”) implements the 1970 United Nations Educational, Scientific and Cultural Organization (UNESCO) Convention on the Means of Prohibiting and Preventing the Illicit Import, Export and Transfer of Ownership of Cultural Property (hereinafter, “the Convention” (823 U.N.T.S. 231 (1972))). Pursuant to the Cultural Property Implementation Act, the United States entered into a bilateral agreement with Ecuador to impose import restrictions on certain Ecuadorean archaeological and ethnological material. This rule announces that the United States is now imposing import restrictions on certain archaeological and ethnological material from Ecuador.

Under 19 U.S.C. 2602(a)(1), the United States must make certain determinations before entering into an agreement to impose import restrictions under 19 U.S.C. 2602(a)(2). On October 19, 2018, the Assistant Secretary for Educational and Cultural Affairs, United States Department of State, after consultation with and recommendation by the Cultural Property Advisory Committee, made the determinations required under the statute with respect to certain archaeological and ethnological material originating in Ecuador that are described in the designated list set forth below in this document.

These determinations include the following: (1) That the cultural patrimony of Ecuador is in jeopardy from the pillage of archaeological or ethnological material representing Ecuador's cultural heritage dating from approximately 12,000 B.C. up to 250 years old, including material starting in the Pre-ceramic period and going into the Colonial period (19 U.S.C. 2602(a)(1)(A)); (2) that the Ecuadorean government has taken measures consistent with the Convention to protect its cultural patrimony (19 U.S.C. 2602(a)(1)(B)); (3) that import restrictions imposed by the United States would be of substantial benefit in deterring a serious situation of pillage and remedies less drastic are not available (19 U.S.C. 2602(a)(1)(C)); and (4) that the application of import restrictions as set forth in this final rule is consistent with the general interests of the international community in the interchange of cultural property among nations for scientific, cultural, and educational purposes (19 U.S.C. 2602(a)(1)(D)). The Assistant Secretary also found that the material described in the determinations meets the statutory definition of “archaeological or ethnological material of the State Party” (19 U.S.C. 2601(2)).

On May 22, 2019, the United States and Ecuador entered into a bilateral agreement, “Memorandum of Understanding between the Government of the United States of America and the Government of the Republic of Ecuador Concerning the Imposition of Import Restrictions on Categories of Archaeological and Ethnological Material of Ecuador” (“the Agreement”), pursuant to the provisions of 19 U.S.C. 2602(a)(2). The Agreement enables the promulgation of import restrictions on categories of archaeological and ethnological material representing Ecuador's cultural heritage that are at least 250 years old, dating as far back as the Pre-ceramic period (approximately 12,000 B.C.) through the Formative, Regional development, Integration, and Inka periods and into the Colonial period. A list of the categories of archaeological and ethnological material subject to the import restrictions is set forth later in this document.

In accordance with the Agreement, importation of material designated below is subject to the restrictions of 19 U.S.C. 2606 and § 12.104g(a) of title 19 of the Code of Federal Regulations (19 CFR 12.104g(a)) and will be restricted from entry into the United States unless the conditions set forth in 19 U.S.C. 2606 and § 12.104c of the CBP regulations (19 CFR 12.104c) are met. CBP is amending § 12.104g(a) of the CBP Regulations (19 CFR 12.104g(a)) to indicate that these import restrictions have been imposed.

Import restrictions listed at 19 CFR 12.104g(a) are effective for no more than five years beginning on the date on which the Agreement enters into force with respect to the United States. This period may be extended for additional periods of not more than five years if it is determined that the factors which justified the Agreement still pertain and no cause for suspension of the Agreement exists. Pursuant to the MOU, the import restrictions entered into force upon delivery of the U.S. diplomatic note to Ecuador on May 22, 2019. Therefore, the import restrictions will expire on May 22, 2024, unless extended.

The Agreement includes, but is not limited to, the categories of objects described in the designated list set forth below. Importation of material on this list is restricted unless the material is accompanied by documentation certifying that the material left Ecuador legally and not in violation of the export laws of Ecuador.

The designated list includes archaeological and ethnological material. Archaeological material of ceramic, stone, metal, and organic tissue ranges in date from approximately 12,000 B.C. to A.D. 1769, which is 250 years from the signing of the Agreement. Ethnological material includes Colonial period ecclesiastical paintings, sculpture, furniture, metalwork, textiles, documents, and manuscripts. In addition, ethnological material includes secular Colonial period paintings, documents, and manuscripts.

National Institute of Cultural Patrimony, Ecuador, Guía de identificación de bienes culturales patrimoniales (Guide for identification of cultural patrimony goods) (2d ed. 2011), http://patrimoniocultural.gob.ec/guia-de-identificacion-de-bienes-culturales-patrimoniales/.

Archaeological material covered by the Agreement is associated with the diverse cultural groups that resided in this region from the earliest human settlement of the Pre-ceramic period and into the Colonial period (approximately 12,000 B.C. to A.D. 1769).

(a) Pre-ceramic period: El Cubilán (12,606 B.C.), Montequinto (11,858 B.C.), Las Mercedes (11,500 B.C.), El Inga (11,000 B.C.), Guagua Canoayacu (9905 B.C.), Gran Cacao (9386 B.C.), Chobshi (9000-6500 B.C.), and Las Vegas (8800-4500 B.C.).

(b) Formative period: Valdivia (3800-1500 B.C.), Mayo Chinchipe (3000-2000 B.C.), Cerro Narrio (2000-400 B.C.), Cotocollao (1800-350 B.C.), Machalilla (1600-800 B.C.), and Chorrera (1000-100 B.C.).

(c) Regional development period: La Tolita (600 B.C.-A.D. 400), Tiaone (600 B.C.-A.D. 400), Bahía (500 B.C.-A.D. 650), Cosanga (500 B.C.-A.D. 1532), Jama Coaque I (350 B.C.-A.D. 100), Upano (300 B.C.-A.D. 500), and Guangala (100 B.C.-A.D. 800).

(d) Integration period: Puruhá (A.D. 300-1500), Cañari (A.D. 400-1500), Atacames (A.D. 400-1532), Jama-Coaque II (A.D. 400-1532), Milagro Quevedo (A.D. 400-1532), Manteño-Huancavilca (A.D. 500-1532), Pasto (A.D. 700-1500), Napo (A.D. 1200-1532), and Caranqui (A.D. 1250-1500).

(e) Inka period: A.D. 1470-1532.

(f) Colonial period: A.D. 1532-1822.

Early chipped stone tools mark the appearance of the first people to inhabit the region and continued to be used throughout history. Polished stone axes became common in the Formative period. Highly skilled stoneworkers created elaborately carved mortars, figurines, seats, and other items for use in daily and ceremonial life. Examples of archaeological stone objects covered in the Agreement include the following objects:

1. Chipped stone tools—Projectile points and tools for scraping, cutting, or perforating are made primarily from basalt, quartzite, chert, chalcedony, or obsidian and are 5-8 cm long.

2. Polished stone tools—Axes or hoes are typically made in basalt or andesite and are about 12 cm long and 8-9 cm wide with a cutting edge on one end and a flat or slightly grooved edge with “ears” on the other side to attach a handle. Some axes have a hole used to attach the handle with cord. Ceremonial axes are highly polished and lack use marks. Hooks, in the shape of small anvils or birds, and weights for spear-throwers ( i.e., atlatls) are made from quartzite, chalcedony, and serpentine. Mace heads and stone shields are made from polished stone.

3. Receptacles—Polished stone bowls may be undecorated or decorated with incisions or notches about 10-20 cm in diameter. Mortars made from volcanic rock may be undecorated or carved in the shape of animals, including felines ( e.g., Valdivia style mortars).

4. Ornaments—Beads are made of quartz, turquoise, and other stone. Round or oval obsidian mirrors are relatively thin with one unworked side and one polished side. Earrings and ear plugs are made from quartz or obsidian.

5. Figurines—Valdivia style human figurines are small (3-5 cm tall) and range from simple plaques to detailed three-dimensional statuettes. These figurines are made from calcium carbonate and often combine feminine and masculine attributes. Quitu-Chaupicruz monoliths are stone posts up to 90 cm tall with tapered bases topped with anthropomorphic figures.

6. Sculpture—Terminal Valdivia style rectangular or square plaques and blocks are made of white or gray volcanic tuff or other stone with smooth faces or faces decorated with lines or circles depicting human or avian imagery. Manteño style seats are monolithic sculptures with U-shaped seats resting on zoomorphic, anthropomorphic, or undecorated pedestals on a rectangular base.

The earliest-known pottery in Ecuador dates to the Formative period (about 4400 B.C.). Highly skilled potters in the region created diverse and elaborate vessels, figurines, sculptural pottery, musical instruments, and other utilitarian and ceremonial items. Ceramics vary widely between archaeological styles. Decorations include paint (red, black, white, green, and beige) or surface decorations such as incisions, excisions, punctations, combing, fingernail marks, corrugations, modelling, etc. Pre-Columbian vessels are never glazed; shiny surfaces are created only by burnishing. Pre-Columbian potters did not use a pottery wheel, so vessels do not have the regular striations or perfectly spherical shapes characteristic of wheel-made pottery. Examples of archaeological ceramic objects covered in the Agreement include the following objects:

1. Vessels—There are three basic types of vessels: Plates, bowls, and jars. Forms and decoration vary among archaeological styles and over time. Some of the most well-known types are highlighted below.

a. Plates have flat or slightly convex bases, occasionally with annular support. Rims are everted, inverted, or vertical, sometimes with zoomorphic modelled appliqué or masks on the exterior. The interior surface is often painted with geometric, anthropomorphic, or zoomorphic designs ( e.g., Carchi style plates). Most Inka style plates from Tomebamba have handles and vertical walls without interior paint and some are flat with handles in the form of a bird or llama. Napo culture platters ( fuentes ) often have polychrome designs.

b. Bowls and cups may have everted or inverted rims, and they may have annular or polypod bases. Interior and/or exterior decorations may be made with incisions, negative painting, iridescent paint, etc. Bowls with pedestal bases are known as compoteras. Carchi style compoteras have anthropomorphic and zoomorphic negative paint designs. A llipta box or poporo is a very small bowl decorated with incisions or paint in round, zoomorphic, or anthropomorphic shapes. [ Note: Llipta is a mixture of lime and/or ash used when chewing coca leaves.] Related to bowls, cups may have everted rims ( e.g., Azuay style and Cañar style cups and Inka keros ) or inverted rims ( e.g., Puruhá style timbales ). Milagro-Quevedo style tripod or pedestal bowls known as cocinas de brujos sometimes have handles and are often decorated with modelled reliefs of snake heads, toads, serpents, and nude human figures.

c. Jars are globular vessels with short necks, sometimes with exterior decoration on the entire vessel or only on the upper half. Jars sometimes have feet, usually three. Bottles are a type of jar with a long spout attached to the body by a handle. Some bottles have stirrup handles. Some bottles have an interior mechanism that regulates movement of air and liquid to create a whistling sound. Very large jars are called cántaros. Cántaros have wide mouths and typically have convex or conical bases; in a few cases, bases are flat and small. Carchi style cántaros or botijuelas are ovoid in shape, have long necks, are decorated with red or negative paint, and sometimes have a modelled human face attached to the neck. Puruhá style cántaros are rounder, with bodies covered in negative paint designs and an everted rectilinear neck that is usually decorated with handles and a modelled human face. Chicha jars or tinajas are very large, usually undecorated jars. Funerary urns may be various sizes depending on whether they contained skeletal remains or ashes. There are two types of Napo style funerary urns with polychrome decorations: Large, elongated vessels with a bulge at the base and anthropomorphic, ceramic statues. Inka style aríbalos have long necks with everted rims and bulging bodies with two handles near the base, a modelled zoomorphic knob near the neck, and a pointed base. Imperial style aríbalos have primarily geometric, polychrome painting. Local style aríbalos have the same shape but are roughly made and undecorated.

2. Figurines—Figurine manufacturing was common in pre-Columbian Ecuador. Anthropomorphic figurines are solid or hollow clay with diverse representations of the body. The size of the figurines varies from less than 10 cm tall to statues over 50 cm tall. Some of the best-known types are described below:

a. Valdivia style ceramic “Venus figures” are small, female figurines in fired clay with detailed treatment of the torso and head. Machalilla and Chorrera figures are larger (up to 40 cm) and usually mold-made and decorated with white slip and red painted designs with humans (more often women than men) depicted in the nude with arms by the side or slightly raised.

b. Low-relief, mold-made figurines were common, including Chorrera style figurines in zoomorphic and phytomorphic shapes ( e.g., squashes, babacos, monkeys, canines, opossums, felines, and birds).

c. Guangala style and Jama-Coaque style figurines use modeled clay to depict body adornments or clothing of men and women. Bodies and ornaments may be painted black, green, red, or yellow. Jama-Coaque figurines, some up to 30 cm tall, with abundant molded decorations and rich painting depict individuals' occupations and social statuses ( e.g., seated shamans with llipta boxes, farmers with bags of seeds and digging sticks, warriors with helmets, spear-throwers and shields, seated jewelry makers with jewels in their laps, hunters carrying or slaughtering their prey, masked figures, dancers with wings or fancy dress, and characters in costumes that indicate privileged status).

d. Figurines from Bahía are generally medium-sized (about 25 cm tall). The “giants of Bahía” are up to 50 cm tall and typically depict shaman figures or elite personages seated cross-legged or standing with elaborate attire, adornment, and headdresses. They often exhibit a necklace adorned with a one to three white tusk-like ornaments.

e. Tolita figurines include individuals of high status and representations of daily life as well as anthropomorphic figures with mammal or bird heads. Tolita style heads and small figures without slip and detailed facial expressions are common. Some hollow heads have perforations and may have been suspended from cords, similar to the tzantzas (shrunken heads) of the Shuar.

f. Manteño style figurines are standardized with polished, black surfaces, almost always standing and with body adornments. There are some seated figures, including Manteño style incense burners depicting men, apparently entranced, with wide plates on their heads and elaborate incisions depicting body tattoos.

g. Carchi coquero figurines depict a seated individual in a hallucinogenic trance with a bulging cheek indicating that the individual is chewing coca. The bulging cheek is also common in Cosanga figurines from Amazonia. Other figurines from Amazonia are rough and their typology is not well known.

3. Musical instruments—During the Integration period, flutes—typically with four finger holes—were common in the northern Sierra. Throughout the coast and highlands, whistles in human or animal form, frequently birds, were common. Ceramic whistles in the form of sea shells (sometimes called ocarinas ) are often decorated with geometric, anthropomorphic, and zoomorphic designs.

4. Masks—Human and zoomorphic masks made of clay, shell, and metal with varied facial expressions were common in pre-Columbian Ecuador. Many masks have small holes along the upper edge so that they can be suspended as pectorals. Rectangular, clay plaques depicting humans, sometimes in erotic motifs, have similar holes for suspension.

5. Stamps—Stamps are made from solid clay, including cylindrical roller stamps and flat stamps with a small handle on one side. Low relief geometric designs include stylized anthropomorphic, phytomorphic, and zoomorphic motifs. Small conical clay spindle whorls called torteros or fusaiolas have similar designs and a hole in the middle to be attached to a spindle.

6. Beads—Beads are small round pieces of ceramic with polished edges and a hole in the center.

7. Graters—Graters are long thin plates, often in the shape of a fish, with a concentration of embedded sharp stones on one side for scraping or grating. Some scrapers lack embedded stones but are decorated with deep incisions in the scraping surface. Bowls occasionally contain embedded scraping stones.

8. Neck rests—Bahía style and Jama-Coaque style neck rests, called descansanucas, are made from a slightly concave, rectangular, ceramic slab resting on a pedestal made from a flat slab of the same size supporting columns or a wide pillar in the shape of a house or human face.

9. House models—House models, or maquetas, from the coastal region have slightly concave roofs and walls that rest on a base that contains stairs and, sometimes, human figures guarding the entrance. In some cases, the interior columns supporting the roof are visible. These are typically found in the Jama-Coaque and La Tolita cultures, and many of them are functioning bottle forms used in drinking rituals. In the northern highlands, models of round houses represent typical domestic structures of the region.

Objects of gold, platinum, silver, copper, and tumbaga (an alloy of copper and gold) were common in pre-Columbian Ecuador. Several pre-Columbian cultures practiced metalwork on the coast ( e.g., Guangala, Bahía, Jama-Coaque, La Tolita, Manteño and Milagro-Quevedo), in the highlands ( e.g., Capulí, Piartal, Puruhá and Cañari), and in Amazonia ( e.g., Cosanga). The Inka introduced bronze, an alloy of copper and tin. Metallurgists were skilled at creating alloys and gold- and copper-plating. Objects were made by using melted metal or hammering metal sheets. Parts of compound objects were made separately and assembled mechanically. Examples of archaeological metal objects covered in the Agreement include the following objects:

1. Tools—Chisels are flat copper strips about 7 cm long and are beveled on one end. Copper needles vary in size from 3 to 8 cm long. There are also copper fish hooks, cylindrical punches, and long-handled spoons. Functional copper axes are similar in shape to stone axes. Ceremonial copper axes lack a cutting edge, are sometimes silver plated, and are decorated on both faces in high and low relief, often in geometric designs.

A tumi is a type of axe with a long handle and a semicircular or rectilinear blade. Axe-monies ( hachas monedas ) are thin, axe-shaped sheets of arsenical copper that are 7-8 cm long and often found in bundles or carefully grouped.

2. Body ornaments—Copper ear piercers may have a hollow handle to facilitate insertion of the post. Gold, silver, and copper crowns and diadems are decorated with engraved or embossed designs. Pre-Columbian people in the region used a wide variety of nose ornaments including oval or circular plates open at the top for insertion into the nasal septum, ornaments with tubular bodies, and scroll or zoomorphic ornaments. Solid or hollow ear ornaments, sometimes with hanging decorations, and labrets are also common. Concave copper disc pectorals with embossed human faces often have holes at the mouth suggesting the existence of a tongue that would have functioned as a rattle. Ornamental clothing pins ( tupos or tupus ) made of copper, silver, and gold are topped with a circular or semicircular plate. Gold masks are made of embossed thin gold sheets. Some masks are a single piece of gold, others have additional elements such as diadems, pendants, and platinum eyes. Necklaces vary and often combine metal, Spondylus shell, and semi-precious stones.

3. Weapons—Bronze star-shaped mace heads typically have six points. Spear or lance points are made from silver sheets rolled into cones leaving a hole for the shaft. Manteño style spear or lance points have a hollow, cylindrical stem to attach the shaft. Gold and silver helmets were made for high-ranking individuals or ceremonial use.

4. Figurines—Small Inka style figurines depict male, female, and animal figures in solid gold or silver.

Ceremonial use and trade of Spondylus princeps, a bivalve mollusk native to the coastal Pacific Ocean from modern Panama to the Gulf of Guayaquil, began during the Formative period. Although preservation of organic material is poor in most of Ecuador, utilitarian tools, instruments, and body ornaments made in bone, shell, and other materials may be found. Examples of archaeological organic objects covered in the Agreement include the following objects:

1. Tools—Sharp bone awls are made from long bones and are often fired to strengthen them. Various bone tools used for weaving include spatulas, needles, combs, shuttles, pick-up sticks, etc. Ritual long-handled spoons are made from bone. Spoons also are made from shell. Shell fish hooks are 3-5 cm in diameter.

2. Musical instruments—Flutes and whistles with a single finger-hole are made from bone. Large gastropod sea shells ( e.g., Strombus sp.) were used as trumpets beginning in Early Valdivia times (around 3000 B.C.).

3. Body ornaments—Ornamental clothing pins ( tupos or tupus ) made from bone usually are topped with a zoomorphic ornament. Shell bracelets, nose rings, and small earrings are common. Ucuyayas are human figures made from Spondylus shell.

4. Human remains—Skeletal remains, soft tissue, and ash from the human body may be preserved in burials and other contexts.

Ethnological material covered by the Agreement includes Colonial period ecclesiastical paintings, sculpture, furniture, metalwork, textiles, documents, and manuscripts. In addition, ethnological material includes secular Colonial period paintings, documents, and manuscripts. Quito School artists incorporated into mostly religious art of the Catholic Church particularities of the Andes such as local costumes, indigenous customs, local flora and fauna, and placement within the Andean countryside or cities.

Colonial period paintings are made on canvas, copper, marble, or wood panels. Pigments are typically made from pulverized minerals mixed with linseed or almond oil. Early 16th-century paintings use muted color palates of reddish browns and grays. By the 18th century, paintings display greater movement, illumination, and color, including intense blues, reds, and greens. Some paintings are decorated with gold leaf rays, stars, or floral designs. Most paintings are anonymous works, but a few are signed. Examples of ethnological paintings covered in the Agreement include, but are not limited to, the following objects:

1. Colonial period ecclesiastical paintings—Ecclesiastical paintings depict religious subjects including Christ, saints, virgins, angels, bishops, popes, and others.

2. Colonial period secular paintings—Secular paintings include landscapes, portraits, allegorical paintings, and casta paintings depicting racial classifications used in the Spanish colonial empire.

Ecclesiastical sculpture from the Colonial period includes images of religious content carved in wood during the 16th, 17th, and 18th centuries. Sculpture may also incorporate silver, gold, bronze, gesso, vegetal ivory ( tagua ), ivory, porcelain, glass eyes, or human hair. Quito School artists produced the finest and most sought-after sculpture in Colonial period Latin America. Quito School 18th-century sculptures are the most famous, including works by Manuel Chili, also known as Caspicara. Examples of ethnological sculpture covered in the Agreement include, but are not limited to, the following objects:

1. Ecclesiastical statues—Ecclesiastical statues carved in wood represent virgins, saints, crucified Christ, baby Jesus, angels and archangels, and figures for nativity scenes. The images are usually life-size. Most statues include the body, face, hands, and clothing sculpted in wood. To give the flesh a luminescent, life-like appearance, artists used the technique of encarnación, a process of painting, varnishing, and sanding the sculpture several times. Clothing is decorated in high relief using techniques such as graffito and estofado that includes layering of paint, lacquer, and gold or silver leaf. Other statues include only carved face and hands attached to a simple wood frame that is covered in robes made from fabric, brocade, or cloth stiffened with gum or paste. Most statues have silver accessories; in the case of the Virgin Mary, these accessories may be halos or coronas, small hearts crossed by a dagger, or earrings or other jewelry.

2. Ecclesiastical relief carvings—Low reliefs or nearly flat sculptures depict saints.

3. Portable altars or triptychs—Small altars of gilded wood or different-colored wood close like boxes, and smaller religious sculptures are stored inside.

Colonial period ecclesiastical furniture was created by teams of designers, carpenters, cabinetmakers, and craftspeople specializing in leather, veneers, or inlaid wood. Additionally, these teams of artisans included carvers, weavers, bronze smiths, locksmiths, and artistic blacksmiths. Examples of ecclesiastical ethnological furniture covered in the Agreement include, but are not limited to, the following objects:

1. Altarpieces or retablos —Elaborate ornamental structures placed behind the altar include attached paintings, sculptures, or other religious objects.

2. Reliquaries and coffins—Containers made from wood, glass, or metal hold and exhibit sacred objects or human remains.

3. Church furnishings—Furnishings used for liturgical rites include pulpits, tabernacles, lecterns, confessionals, pews, choir stalls, chancels, baldachins, and palanquins.

Colonial period ecclesiastical objects made of silver, gold, and other metals were crafted in silversmiths' workshops for use in religious ceremonies. Designs relate to the Eucharist, such as the Lamb of God, a fish, a dove, a cross, fruit, and vine leaves. These ecclesiastical metal objects incorporate precious stones and jewels. Examples of ecclesiastical ethnological metalwork covered in the Agreement include, but are not limited to, the following objects:

1. Sacred vessels—Pyxes, goblets, chalices, and patens were commonly used for religious ceremonies. Urns and custodia (monstrances) were used to display the communion wafer.

2. Altar furnishings—Candlesticks, candelabra, and processional or stationary crosses were used in religious ceremonies. Decorative plaques were affixed to altars.

3. Statue accoutrements—Crowns, radiations, wings, garment pins, and jewelry adorned many ecclesiastical statues.

Textiles used to perform religious services are often made from fine cotton or silk and may be embroidered with metallic or silk thread, brocades, prints, lace, fabrics, braids, and bobbin lace. Examples of textiles covered in the Agreement include, but are not limited to, the following objects:

1. Religious vestments—Garments worn by the priest and/or other ecclesiastics include cloaks, tunics, surplices, chasubles, dalmatics, albs, amices, stoles, maniples, cinctures, rochets, miters, bonnets, and humeral veils complemented by the so-called blancos or “whites.”

2. Coverings and hangings—Textiles used for liturgical celebrations include altar cloths, towels, and tabernacle veils.

Original handwritten texts or printed texts of limited circulation made during the Colonial period are primarily on paper, parchment, and vellum. They include books, single folios, or collections of related documents bound with string. Documents may contain a wax, clay, or ink seals or stamps denoting a public or ecclesiastical institution. Seals may be affixed to the document or attached with cords or ribbons. Because many of these documents are of institutional or official nature, they may have multiple signatures, denoting scribes, witnesses, and other authorities. Documents are generally written in Spanish, but may be composed in an indigenous language such as Quichua. Examples of ethnological documents and manuscripts covered in the Agreement include, but are not limited to, the following objects:

1. Colonial period ecclesiastical documents and manuscripts—These include religious texts, hymnals, and church records.

2. Colonial period secular documents and manuscripts—These include, but are not limited to, notary documents ( e.g., wills, bills of sale, contracts) and documents of the city councils, Governorate of New Castile, Royal Audience of Quito, Viceroyalty of Peru, Viceroyalty of New Granada, or the Council of the Indies.

This amendment involves a foreign affairs function of the United States and is, therefore, being made without notice or public procedure (5 U.S.C. 553(a)(1)). For the same reason, a delayed effective date is not required under 5 U.S.C. 553(d)(3).

Because no notice of proposed rulemaking is required, the provisions of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) do not apply.

CBP has determined that this document is not a regulation or rule subject to the provisions of Executive Order 12866 or Executive Order 13771 because it pertains to a foreign affairs function of the United States, as described above, and therefore is specifically exempted by section 3(d)(2) of Executive Order 12866 and section 4(a) of Executive Order 13771.

This regulation is being issued in accordance with 19 CFR 0.1(a)(1) pertaining to the Secretary of the Treasury's authority (or that of his/her delegate) to approve regulations related to customs revenue functions.

For the reasons set forth above, part 12 of title 19 of the Code of Federal Regulations (19 CFR part 12) is amended as set forth below:

On November 2, 2015, the President signed into law the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (Sec. 701 of Public Law 114-74). Beginning in 2017, the Act requires agencies to make annual inflationary adjustments to their civil monetary penalties by January 15th of each year, in accordance with annual OMB guidance.

In December of every year, OMB issues guidance to agencies to calculate the annual adjustment. According to OMB, the cost-of-living adjustment multiplier for 2020 is 1.01764, based on the Consumer Price Index for the month of October 2019, not seasonally adjusted.

Pursuant to this guidance, the Commission has calculated the annual adjustment level of the civil monetary penalty contained in 25 CFR 575.4 (“The Chairman may assess a civil fine, not to exceed $52,596 per violation, against a tribe, management contractor, or individual operating Indian gaming for each notice of violation . . .”). The 2020 adjusted level of the civil monetary penalty is $53,524 ($52,596 x 1.01764).

This final rule is not a significant rule under Executive Order 12866.

(1) This rule will not have an effect of $100 million or more on the economy or will not adversely affect, in a material way, the economy, productivity, competition, jobs, the environment, public health or safety, or state, local, or tribal governments or communities.

(2) This rule will not create a serious inconsistency or otherwise interfere with an action taken or planned by another agency.

(3) This rule does not involve entitlements, grants, user fees, or loan programs or the rights or obligations of recipients.

(4) This regulatory change does not raise novel legal or policy issues.

The Commission certifies that this rule will not have a significant economic effect on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) because the rule makes annual adjustments for inflation.

This final rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. It will not result in the expenditure by state, local, or tribal governments, in the aggregate, or by the private sector of $100 million or more in any one year. The rule will not result in a major increase in costs or prices for consumers, individual industries, federal, state, or local government agencies, or geographic regions. Nor will this rule have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of the U.S.-based enterprises to compete with foreign-based enterprises.

This final rule does not impose an unfunded mandate of more than $100 million per year on state, local, or tribal governments or the private sector. The rule also does not have a significant or unique effect on state, local, or tribal governments or the private sector. Therefore, a statement containing the information required by the Unfunded Mandates Reform Act (2 U.S.C. 1531 et seq. ) is not required.

Under the criteria in Executive Order 12630, this final rule does not affect individual property rights protected by the Fifth Amendment nor does it involve a compensable “taking.” Thus, a takings implication assessment is not required.

Under the criteria in Executive Order 13132, this final rule has no 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.

This final rule complies with the requirements of Executive Order 12988. Specifically, this rule has been reviewed to eliminate errors and ambiguity and written to minimize litigation. It is written in clear language and contains clear legal standards.

In accordance with the President's memorandum of April 29, 1994, Government-to-Government Relations with Native American Tribal Governments, Executive Order 13175 (59 FR 22951, November 6, 2000), the Commission has determined that consultations with Indian gaming tribes is not practicable, as Congress has mandated that annual civil penalty adjustments in the Act be implemented no later than January 15th of each year.

This final rule does not affect any information collections under the Paperwork Reduction Act.

This final rule does not constitute a major federal action significantly affecting the quality of the human environment.

In developing this final rule, the Commission did not conduct or use a study, experiment, or survey requiring peer review under the Information Quality Act (Pub. L. 106-554).

This final rule is not a significant energy action under the definition in Executive Order 13211. A Statement of Energy Effects is not required.

The Commission is required by Executive Orders 12866 and 12988 and by the Presidential Memorandum of June 1, 1998, to write all rules in plain language. This means that each rule that the Commission publishes must:

(a) Be logically organized;

(b) use the active voice to address readers directly;

(c) use clear language rather than jargon;

(d) be divided into short sections and sentences; and

(e) use lists and tables wherever possible.

In accordance with the Act, agencies are to annually adjust civil monetary penalties without providing an opportunity for notice and comment, and without a delay in its effective date. Therefore, the Commission is not required to complete a notice and comment process prior to promulgation.

For the reasons set forth in the preamble, the Commission amends 25 CFR part 575 as follows:

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

PBGC uses the interest assumptions in appendix B to part 4022 (“Lump Sum Interest Rates for PBGC Payments”) to determine whether a benefit is payable as a lump sum and to determine the amount to pay. Because some private-sector pension plans use these interest rates to determine lump sum amounts payable to plan participants (if the resulting lump sum is larger than the amount required under section 417(e)(3) of the Internal Revenue Code and section 205(g)(3) of ERISA), these rates are also provided in appendix C to part 4022 (“Lump Sum Interest Rates for Private-Sector Payments”).

This final rule updates appendices B and C of the benefit payments regulation to provide the rates for March 2020 measurement dates.

The March 2020 lump sum interest assumptions will be 0.00 percent for the period during which a benefit is (or is assumed to be) in pay status and 4.00 percent during any years preceding the benefit's placement in pay status. In comparison with the interest assumptions in effect for February 2020, these assumptions represent a decrease of 0.25 percent in the immediate rate and are otherwise unchanged.

PBGC updates appendices B and C each month. PBGC has determined that notice and public comment on this amendment are impracticable and contrary to the public interest. This finding is based on the need to issue new interest assumptions promptly so that they are available for plans that rely on our publication of them each month to calculate lump sum benefit amounts.

Because of the need to provide immediate guidance for the payment of benefits under plans with valuation dates during March 2020, PBGC finds that good cause exists for making the assumptions set forth in this amendment effective less than 30 days after publication.

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

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

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

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 II. Background Information and Regulatory History

Recurring boat races, swims, and other marine events within the Seventh Coast Guard District are currently listed in 33 CFR 100.701, Table to § 100.701. The process for amending the table ( e.g. adding or removing marine events) is lengthy and inefficient since it includes recurring marine events for seven different COTP zones within the Seventh District. To expedite and simplify the rulemaking process for new marine events/special local regulations, COTP's resorted to creating individual rules rather than amending Table to § 100.701.

This rule serves two purposes: (1) Create a table of recurring marine events/special local regulations occurring solely within the COTP Miami Zone, and (2) consolidate into that table marine events/special local regulations previously established outside of Table to § 100.701. These revisions facilitate management of and public access to information about marine events and special local regulations within the COTP Miami Zone.

The Coast Guard published a notice of proposed rulemaking (NPRM) on October 2, 2019 titled, “Special Local Regulations; Recurring Marine Events, Sector Miami” (84 FR 52411). There we stated why we published the NPRM, and invited comments on our proposed regulatory. During the comment period that ended November 1, 2019, the Coast Guard did not receive any comments.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70041. The COTP Miami has determined that creating a table of recurring marine events/special local regulations occurring within the COTP Miami Zone, and consolidating into that table marine events/special local regulations in new Table 1 to § 100.702, which were listed in Table to § 100.701 will facilitate management of and public access to information about marine events within the COTP Miami Zone.

As noted above, the Coast Guard did not receive any comments on the NPRM published October 2, 2019. Other than inserting a “1” in the table headings in § 100.701 and § 100.702, and renumbering event-date designators in Table 1 to § 100.702, there are no changes in the regulatory text of this rule from the proposed rule in the NPRM.

This rule creates a table of recurring marine events/special local regulations occurring solely within the COTP Miami Zone, and consolidates into new Table 1 to § 100.702 marine events/special local regulations, which were previously listed in Table to § 100.701. These revisions will facilitate management of and public access to information about marine events within the COTP Miami Zone.

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 minimal effects of the rule. The rule is an administrative action only intended to facilitate management of and public access to information about marine events and special local regulations within the COTP Miami 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 did not receive any 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.

As stated in section V.A above, this rule is an administrative action only intended to better manage information and 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 call or email 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 call or email 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 Environmental Planning COMDTINST 5090.1 (series), 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 an administrative reorganization of established special local regulations for recurring marine events within the COTP Miami Zone. Normally such actions are categorically excluded from further review under paragraphs L61 in Table 3-1 of U.S. Coast Guard Environmental Planning Implementing Procedures 5090.1. A Memorandum for the Record for Categorically Excluded Actions supporting this determination is available in the docket where indicated in ADDRESSES .

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to call or email 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 parts 100 as follows:

Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA.

On December 26, 2019 (84 FR 70913), EPA published a notice of proposed rulemaking (NPRM) for the State of Connecticut. The NPRM proposed approval of SIP revisions that address the interstate transport of air pollution requirements of section 110(a)(2)(D)(i)(I) of the Clean Air Act for the 2008 ozone national ambient air quality standard (NAAQS) ( i.e., ozone transport SIP). The formal SIP revision was submitted by Connecticut on June 15, 2015. In this action, we are approving Connecticut's transport SIP for the 2008 ozone NAAQS.

The rationale for EPA's proposed action is given in the NPRM and will not be restated here. No public comments were received on the NPRM.

EPA is approving a transport SIP that was submitted by Connecticut to address interstate transport requirements for CAA section 110(a)(2)(D)(i)(I) for the 2008 ozone NAAQS as a revision to the Connecticut SIP.

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, 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 regulatory action because this action is not significant 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 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 EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

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

Under section 307(b)(1) of the 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 April 14, 2020. 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 of chapter I, title 40 of the Code of Federal Regulations is amended as follows:

Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA.

On November 18, 2019, EPA proposed to approve a revision to Ohio's PSD rules contained in Ohio Administrative Code (OAC) 3745-31 to include Ohio's 3745-31-34 GHG rule. See 84 FR 63601, November 18, 2019. An explanation of the CAA requirements, a detailed analysis of the proposed revision, and EPA's reasons for proposing approval were provided in the notice of proposed rulemaking (NPRM), and will not be restated here. The public comment period for this proposed rule ended on December 18, 2019. EPA received four comments on the proposal.

During the comment period, EPA received four comments on the November 18, 2019 NPRM. None of the four comments were adverse to the proposed action.

The first comment was anonymous and was in support of the proposed approval of Ohio's GHG rule, and also asked why the rule was only being implemented in Ohio. The second comment was Ohio's December 10, 2019 request that EPA not act on the OAC 3745-31-34(B) paragraph in the submittal. The third comment was from the Ohio Chemistry Technology Council, the Ohio Chamber of Commerce, and the Ohio Manufacturers' Association and was in support of Ohio's December 10, 2019 request that EPA not act on paragraph (B) of Ohio's OAC 3745-31-34 GHG rule. The last comment was anonymous and not germane or relevant to this action because it lacks the required specificity to the proposed SIP revision and relevant requirements of CAA section 110(l). Moreover, the comment does not recommend a different action on the SIP submission from what EPA proposed. All of the comments received are included in the docket for this action. A summary of the comments and EPA's responses are provided below.

Comment 1: The anonymous commenter was in support of the proposed approval of Ohio's GHG rule, but also asked why this GHG rule was only being implemented in Ohio seeing that there are plenty of other states with stationary source projects.

Response 1: OEPA is the air permitting authority for the State of Ohio and can only regulate emissions from permitted sources in Ohio. Other states have developed GHG rules to regulate GHG emissions from their own respective state.

Comment 2: On December 10, 2019, Ohio submitted a comment on the proposed approval of their GHG rule. This comment requested that EPA not act on OAC 3745-31-34(B), thus, this request amends the March 30, 2011 SIP revision submittal. Ohio is considering changes to OAC 3745-31-34(B), (C), and (D), as well as the OAC 3745-77-11 GHG title V rule, thus, requested that EPA not act on those sections.

Response 2: EPA will grant Ohio's request to not act on paragraph (B) of their OAC 3745-31-34 GHG rule. Paragraph (B) is the portion of Ohio's submittal that would have allowed GHG sources with actual emissions of GHGs less than 100,000 tons per year (tpy) to have their potential to emit of GHGs be considered to be less than the 100,000 tpy GHG threshold if they submitted a permit application prior to July 1, 2011. EPA agrees that paragraph (B) is not needed in the Ohio SIP because it is moot due to the fact that Ohio doesn't have any pending permit applications for which might be affected by this rule section which dealt with permit applications submitted prior to July 1, 2011.

Comment 3: The Ohio Chemistry Technology Council, the Ohio Chamber of Commerce and the Ohio Manufacturers' Association expressed support of Ohio's request (see comment 2 above) for EPA to not act on OAC 3744-31-34(B). They explained their concern that paragraph (B) is mooted by time because Ohio doesn't have any pending permit applications prior to July 1, 2011, and that paragraph (B) deals with GHG Tailoring Rule Step 2 sources which are no longer regulated by EPA. The comment further states that approval of paragraph (B) would serve no purpose and would only create confusion over the proper mechanisms for avoiding GHG PSD requirements for sources covered by GHG Tailoring Rule Step 1 sources.

Response 3: EPA agrees with the commenter and will not act on OAC 3745-31-34(B).

EPA is approving Ohio's March 30, 2011 SIP submittal, as amended on August 22, 2019 and December 10, 2019, relating to PSD requirements for GHG-emitting sources in OAC 3745-31-34. Specifically, Ohio's SIP revision establishes appropriate emissions thresholds for determining PSD applicability for new and modified GHG-emitting sources in accordance with EPA's GHG Tailoring Rule and the 2014 Utility Air Regulatory Group (UARG) v. EPA, 134 S. Ct. 2427 decision. Per Ohio's August 22, 2019 and December 10, 2019 amended SIP requests, EPA is not acting on OAC 3745—31-34(B), (C), and (D), or OAC 3745-77-11, which is Ohio's GHG title V rule. In the November 18, 2019 NPRM, EPA proposed to approve OAC 3745-31-34(B), but EPA is not acting on that paragraph due to Ohio's December 10, 2019 request.

As a result of EPA's approval of Ohio's changes to its air quality regulations to incorporate the appropriate thresholds for GHG permitting applicability into Ohio's SIP, paragraph (b) in 40 CFR 52.1873, as included in EPA's PSD Narrowing Rule, is no longer necessary. In this final action, EPA is also amending 40 CFR 52.1873 to remove this unnecessary regulatory language.

In this rule, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of the Ohio Regulations described in the amendments to 40 CFR part 52 set forth below. EPA has made, and will continue to make, these documents generally available through www.regulations.gov, and at the EPA Region 5 Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information). Therefore, these materials have been approved by EPA for inclusion in the State implementation plan, have been incorporated by reference by EPA into that plan, are fully federally enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking of EPA's approval, and will be incorporated by reference in the next update to the SIP compilation. 1

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

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

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

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

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

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

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

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

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

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

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

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

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by April 14, 2020. 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).)

40 CFR part 52 is amended as follows:

Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA.

CAA section 182(b)(2)(A) requires ozone nonattainment areas classified as Moderate or above to revise their SIPs to include provisions to implement reasonably available control technology (RACT). CAA section 184(b)(1)(B) extends the RACT obligation to all areas of states within the Ozone Transport Region (OTR). Pursuant to CAA section 184(a), New Hampshire is a member state of the OTR. States subject to RACT are required to adopt air pollution emission controls for major sources and for sources covered by a Control Technique Guideline (CTG) document issued by the agency either via the adoption or regulations, of by issuance of single source Orders or Permits that outline what the source is required to do to meet RACT.

On December 10, 2019, New Hampshire submitted RACT Order RO-0005, dated November 20, 2019, which it issued to PSI Plastic Moldings located in Wolfeboro. The facility produces custom molded products and uses metal and plastic parts coatings in its operation. The facility is subject to New Hampshire regulation Env-A 1212, which contains VOC content limits for miscellaneous metal and plastic parts coatings. Some of the coatings used by the facility exceed the VOC content limit of Env-A 1212, but others are below those limits. RACT Order RO-0005 allows the facility to demonstrate compliance with Env-A 1212 using a weighted averaging technique that demonstrates that total emissions from all coatings are equal to or less than what emissions would be if all of the coatings met the emission limits within Env-A 1212. The facility is required to demonstrate compliance using this weighted averaging technique, referred to as a “bubble calculation” described within the Order, on a monthly basis. We agree that this compliance method described within Order RO-0005 is an acceptable, enforceable approach, and are approving the Order into the New Hampshire SIP.

We are approving a single source order establishing VOC RACT for PSI Molded Plastics in Wolfeboro, into the New Hampshire SIP.

The EPA is publishing this action without prior proposal because the Agency views this as a noncontroversial amendment and anticipates no adverse comments. However, in the proposed rules section of this Federal Register publication, EPA is publishing a separate document that will serve as the proposal to approve the SIP revision should relevant adverse comments be filed. This rule will be effective April 14, 2020 without further notice unless the Agency receives relevant adverse comments by March 16, 2020.

If the EPA receives such comments, then EPA will publish a document withdrawing the final rule and informing the public that the rule will not take effect. All public comments received will then be addressed in a subsequent final rule based on the proposed rule. The EPA will not institute a second comment period on the proposed rule. All parties interested in commenting on the proposed rule should do so at this time. If no such comments are received, the public is advised that this rule will be effective on April 14, 2020 and no further action will be taken on the proposed rule. Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment.

In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of New Hampshire RACT Order RO-0005, dated November 20, 2019, described in 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 1 Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information). Therefore, these materials have been approved by EPA for inclusion in the State implementation plan, have been incorporated by reference by EPA into that plan, are fully federally enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking of EPA's approval, and will be incorporated by reference 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 Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the 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 regulatory action because this action is not significant 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 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 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. Section 804, however, exempts from section 801 the following types of rules: Rules of particular applicability; rules relating to agency management or personnel; and rules of agency organization, procedure, or practice that do not substantially affect the rights or obligations of non-agency parties. 5 U.S.C. 804(3). Because this is a rule of particular applicability, EPA is not required to submit a rule report regarding this action under section 801.

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 April 14, 2020. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the proposed rules section of this Federal Register , rather than file an immediate petition for judicial review of this direct final rule, so that EPA can withdraw this direct final rule and address the comment in the proposed rulemaking. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

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

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

The background for this action is discussed in detail in our May 16, 2019 Proposal (84 FR 22093, “Proposal”). In that document we proposed to: (1) Approve the plan for maintaining both the revoked 1979 1-hour and 1997 8-hour ozone NAAQS  1 through 2032 in the HGB area; (2) Approve 30 Texas Administrative Code (TAC) sections 101.100-101.102, 101.104, 101.106-101.110, 101.113, 101.116, 101.117, 101.118(a)(1), 101.118(a)(3), and 101.120-101.122 as an equivalent alternative 185 fee program to address CAA section 185; (3) Determine that the HGB area is continuing to attain both the revoked 1-hour and 1997 ozone NAAQS; (4) Determine that Texas (“the State”) has met the CAA criteria for redesignation of the HGB area; and, (5) Terminate all anti-backsliding obligations for the HGB area for both the 1-hour and 1997 ozone NAAQS.

In this final action, we are approving the plan for maintaining both the 1-hour and 1997 ozone NAAQS through the year 2032 in the HGB area. We are also approving the HGB Severe Ozone Nonattainment Area Failure to Attain Fee regulations program as an equivalent alternative program to address section 185 of the CAA for the 1-hour ozone NAAQS. We are also determining that the HGB area continues to attain both the 1-hour and 1997 ozone NAAQS and has met the five criteria in CAA section 107(d)(3)(E) for redesignation.

The EPA revoked both the 1-hour and 1997 ozone NAAQS along with associated designations and classifications (69 FR 23951, April 30, 2004; and, 80 FR 12264, March 6, 2015), and thus, the HGB area has no designation under both the 1-hour or 1997 ozone NAAQS that can be changed through redesignation as governed by CAA section 107(d)(3)(E). Therefore, we are not promulgating a redesignation of the HGB area under CAA section 107(d)(3)(E). However, because the HGB area has met the five criteria in section 107(d)(3)(E) for redesignation, we are terminating all anti-backsliding obligations for the HGB area for both the revoked 1-hour and 1997 ozone NAAQS.

To determine the criteria under CAA section 107(d)(3)(E) are met, we must do the following: (1) Determine that the area has attained the NAAQS; (2) Fully approve the applicable implementation plan for the area under CAA section 110(k); (3) Determine that the improvement in air quality is due to permanent and enforceable reductions in emissions resulting from implementation of the applicable implementation plan and Federal air pollutant control regulations and other permanent and enforceable reductions; (4) Fully approve a maintenance plan for the area as meeting the requirements of CAA section 175A; and, (5) Determine the state containing such area has met all requirements applicable to the area under CAA section 110 (Implementation plans) and Part D (Plan Requirements for Nonattainment Areas).

As discussed in our Proposal, in the Technical Support Document (TSD) for this action, 2 and in the remainder of this preamble, the five criteria above have been met. In past actions, we have determined that the area has attained the 1-hour and 1997 ozone NAAQS due to permanent and enforceable measures (Criteria 1 and 3). As discussed in the Proposal and in this final action, air quality in the HGB area has been meeting the 1-hour standard since 2013 and the 1997 ozone standard since 2014. As documented in the Proposal and the TSD, numerous State, Federal and local measures have been adopted and implemented including NOx and Highly Reactive Volatile Organic Compounds (HRVOC)  3 mass emissions cap and trade programs and federal on- and off-road emissions control programs which have resulted in significant reductions and resulted in attainment of the 1-hour and 1997 ozone standards.

We are also finding that the area has met all requirements under CAA section 110 and part D that are applicable for purposes of redesignation, and all such requirements have been fully approved (Criteria 2 and 5). As discussed in the Proposal, for the revoked ozone standards at issue here, over the past three decades the State has submitted numerous SIPs for the HGB area to implement those standards, improve air quality with respect to those standards, and address anti-backsliding requirements for those standards. The TSD documents many of these actions and EPA approvals. However, EPA has consistently held the position that not every requirement to which an area is subject is applicable for purposes of redesignation. See, e.g., September 4, 1992, Memorandum from John Calcagni (“Calcagni Memorandum”). 4 As described in the Calcagni Memorandum, some of the Part D requirements, such as demonstrations of reasonable further progress, are designed to ensure that nonattainment areas continue to make progress toward attainment. EPA has interpreted these requirements as not “applicable” for purposes of redesignation under CAA section 107(d)(3)(E)(ii) and (v) because areas that are applying for redesignation to attainment are already attaining the standard. Similarly, as explained further below, EPA believes that the CAA section 185 fee requirement is not applicable for the purposes of redesignation. We note that we are approving the HGB equivalent alternative section 185 fee program for the revoked 1-hour ozone standard separately in this action but do not believe it is an applicable requirement for redesignation. This means that we are terminating this requirement.

Finally, we are fully approving the maintenance plan for the HGB area. As discussed in the Proposal, we agree that Texas has provided a plan that demonstrates that the HGB area will maintain attainment of the revoked 1-hour and 1997 standards until 2032. The plan also includes contingency measures that would be implemented in the HGB area should the area monitor a violation of these standards in the future.

We received comments from six entities on the proposed rulemaking. These comments are available for review in the docket for this rulemaking. The comments were submitted by the following: Earthjustice (on behalf of five national, regional, and grassroots groups); Baker Botts, L.L.P on behalf of the Section 185 Working Group and BCCA Appeal Group (“Baker Botts”); the Texas Commission on Environmental Quality (TCEQ or State); the Texas Oil and Gas Association (TXOGA); and two anonymous commenters. Our responses to all relevant comments follow. Any other comments received were either deemed irrelevant or beyond the scope of this action and are also included in the docket to this action.

Comment: An anonymous commenter (“Commenter”) states that EPA mistakenly evaluates annual emissions inventories for nitrogen oxides (NO X ) and volatile organic compounds (VOC) to show maintenance of the NAAQS. Commenter states that EPA must re-evaluate based on typical ozone season day values and show that permanent and enforceable measures have been enacted to maintain ozone season day averages that limit 1-hour and 8-hour ozone levels.

Response: As described in our TSD, attainment of these ozone NAAQS is determined by reviewing specific data averaged over a three-year period. For example, the 1997 ozone standard is attained when the 3-year average of the annual fourth highest daily maximum 8-hour average ambient air quality ozone concentration is less than or equal to 0.08 ppm  5 (69 FR 23857, April 30, 2004). 6 Also, as mentioned in our TSD, ground-level ozone is formed when NO X and VOC react in the presence of sunlight. Therefore, having an inventory of emissions for NO X and VOC at the time the area first met both of these NAAQS ( i.e., in 2014) helps determine what levels of emissions would be needed to maintain these NAAQS in the HGB area. As indicated in our Proposal, the 2014 base year emission inventories (EIs) for NO X and VOC represent the first year in which the HGB area is attaining both the 1-hour and 1997 ozone NAAQS and thus provide a starting point against which to evaluate the EI levels estimated for future years. In addition, consistent with the Calcagni Memorandum regarding a Maintenance Demonstration, “[a] State may generally demonstrate maintenance of the NAAQS by either showing that future emissions of a pollutant or its precursors will not exceed the level of the attainment inventory or by modeling to show that the future mix of sources and emission rates will not cause a violation of the NAAQS.” Calcagni Memorandum at 4. Because the State's estimated future EIs for the HGB area do not exceed the 2014 base year EI ( i.e., the attainment inventory), we would not expect the area to have emissions leading to a violation of the 1-hour or 1997 ozone NAAQS.

We disagree that we must re-evaluate based on “typical ozone season day values” because the EIs submitted by the State and evaluated in our Proposal were comprised of ozone season daily emissions of NO X and VOC. No re-evaluation is necessary. We agree that we must determine that improvements in air quality are due to permanent and enforceable reductions in emissions in the HGB area, and we listed such measures in Appendix A of our TSD. For example, one of the emission reduction measures adopted in the HGB Area under the 1-hour ozone NAAQS is the HRVOC emissions cap, whose estimated VOC emission reductions were 135.79 tons per day (tpd) (see 71 FR 52656, September 6, 2006). See Appendix A in the TSD for a list of the permanent and enforceable measures approved in the HGB area under the 1-hour and 1997 ozone NAAQS. 7 Finally, in prior final actions, we established that the HGB area has attained the 1-hour and 1997 ozone NAAQS due to permanent and enforceable emission reductions. 8

We proposed to find that the HGB area met all five redesignation criteria in CAA section 107(d)(3)(E), consistent with the decision of the U.S. Court of Appeals for the District of Columbia Circuit in South Coast Air Quality Management District v. EPA, 882 F.3d 1138 (D.C. Cir. 2018) (“ South Coast II” ) for the revoked ozone standards and to terminate the anti-backsliding obligations for the HGB area associated with these standards. In the alternative, we proposed to redesignate the HGB area to attainment for the revoked ozone standards, taking comment on whether we had authority to do so. In this action, based upon comments received, we are finalizing the first option.

Comment: Earthjustice states that ozone is a serious health problem in Houston.

Response: We agree that ozone is a significant health issue in the HGB area, but we also recognize that significant progress has been made in reducing ozone levels in the area. This action recognizes that the HGB area has met air emissions reductions milestones with respect to both the revoked 1-hour and 1997 ozone NAAQS. We also recognize that further air quality improvement is necessary in the area to meet the two current 2008 and 2015 ozone NAAQS and to protect public health. The HGB area was designated as nonattainment for both the revoked 1-hour and 1997 ozone NAAQS and is designated as nonattainment for the two current (2008 and 2015) 8-hour ozone NAAQS. 9 As a result, the State and HGB area—including local governments, business and industry—have implemented measures to reduce emissions of NO X and VOC that form ozone ( see, e.g., Appendix A: Permanent and Enforceable Measures Implemented in the HGB Area, in the TSD for this action). Accordingly, the HGB area has seen its 1-hour ozone design values decrease from over 200 parts per billion (ppb) in 1997 to 112 ppb in 2018. Likewise, the HGB area design values for the 8-hour ozone NAAQS have decreased from 102 ppb in 2003 to 78 ppb in 2018. 10 Because the area has attained the revoked 1-hour and 1997 ozone NAAQS, and has also met the other CAA statutory requirements for redesignation for these standards, we believe it is appropriate to terminate the anti-backsliding requirements associated with these revoked NAAQS.

The area will remain designated nonattainment for the 2008 and 2015 ozone NAAQS. The HGB area was recently reclassified as a Serious nonattainment area for the 2008 ozone NAAQS, and therefore the State must submit SIP revisions and implement controls to satisfy the statutory and regulatory requirements for a Serious nonattainment area for the 2008 ozone standard. 11

Comment: Earthjustice states that EPA cannot lawfully or rationally apply the criteria at CAA section 107(d)(3)(E) to terminate anti-backsliding protections for the Houston area, because that statutory provision provides only minimum criteria that must be satisfied before a designated nonattainment area may be redesignated to attainment. Earthjustice states that the provision provides no authority to terminate anti-backsliding on the basis of an area meeting its criteria for a revoked standard. The commenter also states that EPA does not and cannot identify a source of authority for its application of the statutory provision for the purposes of terminating anti-backsliding provisions and has not purported to create regulations here under its general rulemaking authority of Clean Air Act section 301(a) to do so. Finally, the commenter alleges that the EPA's reliance on South Coast II to support its authority to terminate HGB's anti-backsliding requirements for the two revoked ozone NAAQS is unlawful and arbitrary. Earthjustice argues that the D.C. Circuit in South Coast II held only that the redesignation substitute was unlawful because it fell short of certain statutory requirements and did not address any other reasons why the regulation was unlawful and arbitrary. The commenter alleges that South Coast II “says nothing” about whether EPA could lawfully authorize termination of anti-backsliding requirements in the circumstance addressed here, where the area continues to violate the 2008 and 2015 ozone NAAQS, and where termination “weakens protections in the area.” Earthjustice states that the South Coast II court's holding with respect to the EPA's authority to reclassify areas after revocation is irrelevant to the question of the EPA's authority to change an area's designation after revocation.

Response: We disagree that the EPA lacks authority to terminate an area's anti-backsliding requirements for a revoked NAAQS and that we may not do so here for the HGB area with respect to the two revoked ozone NAAQS in question. The commenter's suggestion that the EPA may not look to the statutory redesignation criteria in CAA section 107(d)(3)(E) for authority to terminate the HGB area's anti-backsliding requirements is contradicted by the D.C. Circuit's decision in South Coast II. In that decision, the court faulted the redesignation substitute, one of the EPA's mechanisms for terminating anti-backsliding, but only because it had addressed only some, and not all, of the statutory redesignation criteria:

We disagree that the D.C. Circuit “said nothing” with respect to how anti-backsliding controls could be lawfully terminated for areas under a revoked NAAQS. The court stated that the Act “unambiguously” requires that all five statutory redesignation criteria be met before anti-backsliding controls ( i.e., controls associated with the nonattainment designation for a revoked NAAQS) could be shed. Id. The court's express basis for vacating the redesignation substitute was that the mechanism failed to incorporate all of the statutory criteria as preconditions. Id. (“Because the `redesignation substitute' does not include all five statutory requirements, it violates the Clean Air Act.”). We do not agree with the commenter's suggestion that the EPA may not rely on the court's plain interpretation of the Act and act in accordance with it. The EPA had previously approved redesignation substitutes for the HGB area for the 1-hour ozone NAAQS and the 1997 ozone NAAQS. As discussed in our Proposal, this final action replaces our previous approvals of the Houston area redesignation substitutes for the 1-hour and 1997 ozone NAAQS.

Furthermore, we reject the commenter's suggestion that nonattainment of the newer, current NAAQS is a unique set of circumstances that would reasonably alter the EPA's ability to either redesignate an area or terminate anti-backsliding requirements for a prior NAAQS. Nothing in CAA section 107(d)(3) suggests that the EPA's approval of a redesignation or termination of anti-backsliding for one NAAQS should include evaluation of attainment of another newer NAAQS. It is common practice that areas designated nonattainment for an earlier, less stringent NAAQS come into compliance with that NAAQS, meet the requirements for redesignation for that NAAQS, and are redesignated to attainment for that NAAQS, while remaining nonattainment for a newer more stringent standard for the same pollutant. Indeed, with Congress' directive that the EPA review and revise the NAAQS as appropriate no less frequently than every five years, it would be nearly impossible for areas to be redesignated to attainment for an older NAAQS if nonattainment of a newer (often more stringent) standard barred EPA from approving redesignation requests for the older standard.

We also disagree that this action's effects terminating anti-backsliding requirements are in any way “unique.” Areas that are redesignated to attainment are permitted to stop applying nonattainment area New Source Review offsets and thresholds and transition to the Prevention of Significant Deterioration program, which the EPA does not agree is an unwarranted “weakening” of protections. In this case, because the HGB area remains nonattainment for the newer ozone NAAQS, it will continue to be subject to nonattainment new source review (NNSR) emissions offsets and threshold requirements, tailored to the current classifications that apply to the area. We do not agree that it is arbitrary or unlawful to hold areas that were nonattainment for a revoked NAAQS to the same standards that apply to areas that are nonattainment for the current NAAQS. EPA does not agree with commenter's suggestion that areas that have reached attainment should be subject to a more stringent process to shed obligations under a revoked NAAQS than the process required to shed obligations for a current NAAQS.

Finally, with respect to Earthjustice's comment that the South Coast II court's holding regarding reclassification does not support an interpretation that the EPA has the authority to alter designations, the EPA is not finalizing a change in designation for the area for the two revoked NAAQS. Because we are not redesignating the HGB area to attainment no further response to this specific comment is required.

Comment: Earthjustice states that EPA cannot lawfully or rationally change Houston's designation under revoked standards.

Response: The EPA is not changing the designation for the HGB area under the 1-hour or 1997 ozone NAAQS in this action. As noted above, the designations for these areas were revoked when the NAAQS were revoked. In this action, EPA is terminating the anti-backsliding requirements associated with the two revoked NAAQS in this area.

Comment: Earthjustice states that EPA arbitrarily fails to consider the consequences of terminating anti-backsliding protections. The commenter asserts that the EPA is not legally obligated to redesignate an area that meets criteria of CAA section 107(d)(3)(E), and that additionally, the EPA must also determine whether it should redesignate the area. Earthjustice states that finalization of this Proposal would ratify termination of key anti-backsliding protections, particularly the Severe area NNSR protections that would otherwise apply to proposed new and modified stationary sources and work to impose more stringent limits on harmful ozone-forming pollution attributable to those new and modified stationary sources. By authorizing Houston to have weaker protections than it otherwise would, while still having severely harmful levels of ozone air pollution, Earthjustice claims that the EPA's action irrationally deprives Houston communities of CAA public health protections intended to bring the area expeditiously into compliance with health-based ozone standards.

Response: As stated previously, we are not in this action redesignating the HGB area for the revoked NAAQS. Rather, we find that all five CAA statutory criteria for redesignation are met, and therefore anti-backsliding obligations for the revoked NAAQS are appropriately terminated. We do not agree that the facts and circumstances before us support the commenter's reading that, despite Texas having met all five statutory criteria, the EPA should withhold approval of the state's request.

We note that we have considered the consequence of terminating anti-backsliding protections raised by the commenter, i.e., the Severe classification requirements for NNSR. We believe that the improvement in air quality due to the permanent, enforceable controls included in the Texas SIP for the HGB area makes termination of these Severe area requirements appropriate and, as discussed previously, consistent with the Act's provisions.

We note NNSR is still in place because the area remains nonattainment under the 2008 and 2015 standards. The HGB area is classified as a Marginal nonattainment area under the 2015 ozone NAAQS, and a Serious nonattainment area under the 2008 ozone NAAQS and as such, is required to implement NNSR consistent with the Serious area classification, as required by CAA sections 182(c)(6), 182(c)(7), 182(c)(8), and 182(c)(10). 12 13 In addition, approval of this final action does not relieve sources in the area of their obligations under previously established permit conditions. The Texas SIP includes a suite of approved permitting regulations for the Minor and Major NNSR for ozone that will continue to apply in the HGB area even after final approval of this action. 14 Each of these permitting regulations has been evaluated and approved by EPA into the SIP as consistent with the requirements of the CAA and protective of air quality, including the requirements at 40 CFR 51.160 whereby the TCEQ cannot issue a permit or authorize an activity that will result in a violation of applicable portions of the control strategy or that will interfere with attainment or maintenance of a NAAQS. Thus, new sources and modifications will continue to be permitted and authorized under the existing SIP permitting requirements if they are determined to be protective of air quality.

This action recognizes that the HGB area met the requirements for redesignation for both the revoked 1-hour and 1997 ozone NAAQS and as a result it is appropriate to relieve the area of the Severe NNSR requirements associated with these revoked standards.

Comment: Earthjustice states that Houston was the only area in Texas to report violations of the revoked 1-hour standard in 2018, exceeding the standard at eleven air monitor locations on five days. Earthjustice states that EPA cannot rationally terminate anti-backsliding protections in Houston as the area continues to experience some of the worst air pollution in the nation.

Response: We do not agree that the HGB area experienced violations of the 1-hour ozone NAAQS in 2018. The area has consistently continued to attain that NAAQS since 2013. As noted above, the statutory requirements for redesignation (and in this case, for termination of anti- backsliding) are not dependent on whether the area is failing to attain newer, more stringent NAAQS. Nor do we think it would be appropriate to disapprove a state's request to terminate anti-backsliding because an area experienced worse air quality than other areas in the nation, if that area met the statutory criteria associated with redesignation for that prior revoked NAAQS. The HGB area continues to be subject to the CAA statutory and regulatory requirements to meet the more stringent ozone NAAQS, and this action does not alter that obligation.

We acknowledge that in 2018 the HGB area experienced several exceedances of the 1-hour ozone NAAQS. An exceedance of the 1-hour ozone NAAQS occurs when the maximum hourly average concentration at an ozone monitor is above 0.12 parts per million (or 120 ppb)  15 and as Earthjustice notes, there were exceedances at monitors in the HGB area. Six of the regulatory monitors in the HGB area each recorded one exceedance, and a seventh regulatory monitor recorded two exceedances. 16 However, these exceedances did not result in a violation of the 1-hour ozone NAAQS. As described earlier in this document and in our TSD, the 1-hour ozone NAAQS is determined by reviewing specific data averaged over a three-year period. The number of exceedances at a monitoring site would be recorded for each calendar year and then averaged over the past 3 calendar years to determine if this average is less than or equal to 1. A violation occurs when this average is greater than 1. Table 1 in this final action shows the 1-hour ozone exceedances by monitor in the HGB area for calendar years 2014 through 2018 to demonstrate the area's continued attainment of the 1-hour ozone NAAQS. 17 In addition, Table 1 in our Proposal provided the preliminary 2016-2018 1-hour and 1997 ozone design values for the HGB area. Quality-assured data collected through 2018 and preliminary data for 2019 indicate that the area has continued to maintain these NAAQS (see Table 2).

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

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

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-2019-0279 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before April 14, 2020. 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-2019-0279, by one of the following methods:

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

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

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

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

In the Federal Register of August 2, 2019 (84 FR 37818) (FRL-9996-78), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-11271) by Spring Trading Company (203 Dogwood Trail, Magnolia, TX 77354-5201) on behalf of BASF Corporation (100 Campus Drive, Florham Park, NJ 07932). The petition requested that existing exemptions from the requirement of a tolerance for residues of propanamide, 2-hydroxy-N, N-dimethyl- (CAS Reg. No. 35123-06-9) when used as an inert ingredient (solvent/co-solvent) applied to growing crops and raw agricultural commodities after harvest (40 CFR 180.910) or in pesticides applied to animals (§ 180.930) be amended by increasing the limitation in pesticide formulations from 20% to 50%. That document referenced a summary of the petition prepared by Spring Trading Company on behalf of BASF Corporation, the petitioner, which is available in the docket, http://www.regulations.gov. One relevant comment was received on the notice of filing. EPA's response to this comment is discussed in Unit V.B.

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

Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(c)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. EPA is required to consider the factors of section 408(b)(2)(C) and (D) in making determinations of safety for exemptions. 21 U.S.C. 346a(c)(2)(B). Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”

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

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

EPA has evaluated the available toxicity data and considered their validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the adverse effects caused by propanamide, 2-hydroxy-N, N-dimethyl- as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are discussed in this unit.

Propanamide, 2-hydroxy-N, N-dimethyl- is of low acute oral, dermal and inhalation toxicity in rats; all LD 50 s are greater than 1,000 mg/kg. Dermal irritation is not observed in rabbits. It is mildly irritating to the eyes of rabbits. It is not a dermal sensitizer in mice in the lymph node assay.

The toxicity studies summarized below were all conducted with propanamide, 2-hydroxy-N, N-dimethyl- except the chronic toxicity study. That study was conducted with N, N-dimethylacetamide, a structurally similar chemical. The only difference between the two chemicals is that N, N-dimethylacetamide is missing a hydroxyl group on a carbon atom. Both compounds are expected to undergo similar metabolism (in this case, N-oxidation) by cytochrome P450 enzymes and have similar toxicological profiles; therefore, the Agency has determined the data to be suitable for evaluating propanamide.

In rats, 90 days of oral exposure to propanamide, 2-hydroxy-N, N-dimethyl- results in increased cholesterol and triglyceride levels, increased liver weights and centrilobular hypertrophy at 1,000 mg/kg/day, the limit dose. The NOAEL is 500 mg/kg/day. Reproduction parameters, estrus cyclicity and sperm parameters were also evaluated in this study and were found to be unaffected at 1,000 mg/kg/day.

A developmental toxicity study in rats showed no maternal toxicity at 500 mg/kg/day, the highest dose tested. Quantitative fetal susceptibility was observed as reduced body weight in pups at 500 mg/kg/day. The developmental NOAEL was 200 mg/kg/day.

Propanamide, 2-hydroxy-N, N-dimethyl- was not mutagenic in the Chinese hamster ovary (CHO) cells HGPRT locus gene mutation assay or the micronucleus test.

Propanamide, 2-hydroxy-N, N-dimethyl- is not expected to be carcinogenic based on the absence of structural alerts using Derek Nexus program and the lack of mutagenicity. It is not expected to be neurotoxic based on the functional observation battery or on motor activity in the 90-day oral toxicity study in rats.

Immunotoxicity studies for propanamide, 2-hydroxy-N, N-dimethyl- were not available for review. However, evidence of immunotoxicity was not observed in the submitted studies.

Chronic studies with propanamide, 2-hydroxy-N, N-dimethyl- are not available for review. However, a chronic study conducted for 12 months in rats treated with N, N-dimethylacetamide, a structurally similar chemical, was used as surrogate data. In this study toxicity manifested as reduced bodyweight was observed at 300 mg/kg/day. The NOAEL is 100 mg/kg/day.

A dermal penetration study in rats showed that 50% of 2-hydroxy-N, N-dimethyl- is absorbed following 8 hours of exposure on skin. Therefore, the dermal absorption factor of 50% was used for risk assessment purposes.

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

An acute effect was not found in the database therefore an acute dietary assessment is not necessary. The chronic reference dose (cRfD) as well as the toxicity endpoint applicable to all exposure scenarios was based on the 12-month chronic toxicity study in rats. In this study, the NOAEL was 100 mg/kg/day based on reduced bodyweights at 300 mg/kg/day, the LOAEL. This represents the lowest NOAEL in the most sensitive species in the toxicity database. The standard uncertainty factors were applied to account for interspecies (10X) and intraspecies (10X) variations. The FQPA safety factor was reduced to 1x. The dermal absorption factor of 50% was applied based on a dermal penetration study in rats. A default value of 100% was used for the inhalation absorption factor.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to propanamide, 2-hydroxy-N, N-dimethyl-, EPA considered exposure under the proposed exemption from the requirement of a tolerance. EPA assessed dietary exposures from propanamide, 2-hydroxy-N, N-dimethyl- in food as follows:

Dietary exposure (food and drinking water) to propanamide, 2-hydroxy-N, N-dimethyl- can occur following ingestion of foods with residues from treated crops and animals. Because no adverse effects attributable to a single exposure of propanamide, 2-hydroxy-N, N-dimethyl- are seen in the toxicity databases, an acute dietary risk assessment is not necessary. For the chronic dietary risk assessment, EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID TM , Version 3.16, and food consumption information from the U.S. Department of Agriculture's (USDA's) 2003-2008 National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in food, no residue data were submitted for propanamide, 2-hydroxy-N, N-dimethyl-. In the absence of specific residue data, EPA has developed an approach which uses surrogate information to derive upper bound exposure estimates for the subject inert ingredient. Upper bound exposure estimates are based on the highest tolerance for a given commodity from a list of high use insecticides, herbicides, and fungicides. One hundred percent crop treated was assumed, default processing factors, and tolerance-level residues for all foods and use limitations of not more than 50% by weight in pesticide formulations. A complete description of the general approach taken to assess inert ingredient risks in the absence of residue data is contained in the memorandum entitled “Alkyl Amines Polyalkoxylates (Cluster 4): Acute and Chronic Aggregate (Food and Drinking Water) Dietary Exposure and Risk Assessments for the Inerts,” (D361707, S. Piper, 2/25/09) and can be found at http://www.regulations.gov in docket ID number EPA-HQ-OPP-2008-0738.

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

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

Propanamide, 2-hydroxy-N, N-dimethyl- may be used in inert ingredients in products that are registered for specific uses that may result in residential exposure, such as pesticides used in and round the home. The Agency conducted an assessment to represent worst-case residential exposure by assessing propanamide, 2-hydroxy-N, N-dimethyl- in pesticide formulations (outdoor scenarios) and in disinfectant-type uses (indoor scenarios), limited to 5% by weight in pesticide formulations.

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 propanamide, 2-hydroxy-N, N-dimethyl- to share a common mechanism of toxicity with any other substances, and propanamide, 2-hydroxy-N, N-dimethyl- does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that propanamide, 2-hydroxy-N, N-dimethyl- 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://www.epa.gov/pesticides/cumulative.

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.

The toxicity database for propanamide, 2-hydroxy-N, N-dimethyl- contains a subchronic, developmental, chronic, and mutagenicity studies. There is no indication of neurotoxicity or immunotoxicity in the available studies; therefore, there is no need to require neurotoxicity or immunotoxicity studies. Quantitative fetal susceptibility was observed in the developmental study in rats. Fetal toxicity (reduced bodyweight) was observed at 500 mg/kg/day, the highest dose tested, while toxicity was not observed in maternal animals. The developmental NOAEL was 200 mg/kg/day. However, fetal effects are not of concern since the cRfD (1 mg/kg/day) will be protective of effects seen at 500 mg/kg/day. In addition, the Agency used conservative exposure estimates, with 100 percent crop treated, tolerance-level residues, conservative drinking water modeling numbers, and a worst-case assessment of potential residential exposure for infants and children. Based on the adequacy of the toxicity and exposure databases and the lack of concern for prenatal and postnatal sensitivity, the Agency has concluded that there is reliable data to determine that infants and children will be safe if the FQPA SF of 10X is reduced to 1X.

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

1. Acute risk. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to propanamide, 2-hydroxy-N, N-dimethyl- from food and water will utilize 70.6% of the cPAD for children 1 to 2 years old, the population group receiving the greatest exposure.

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

Propanamide, 2-hydroxy-N, N-dimethyl- may be used as an inert ingredient in pesticide products 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 propanamide, 2-hydroxy-N, N-dimethyl-. Using the exposure assumptions described above, EPA has concluded that the combined short-term aggregated food, water, and residential exposures result in MOEs of 374 for both adult males and females. Adult residential exposure combines high-end dermal and inhalation handler exposure from liquids/trigger sprayer/home garden with a high-end post- application dermal exposure from contact with treated lawns. EPA has concluded the combined short-term aggregated food, water, and residential exposures result in an aggregate MOE of 132 for children. Children's residential exposure includes total exposures associated with contact with treated lawns (dermal and hand-to-mouth exposures). As the level of concern is for MOEs that are lower than 100, this MOEs is not of concern.

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

Propanamide, 2-hydroxy-N, N-dimethyl- may be used as an inert ingredient in pesticide products that could result in intermediate-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with intermediate-term residential exposures to propanamide, 2-hydroxy-N, N-dimethyl-. Using the exposure assumptions described above, EPA has concluded that the combined intermediate-term aggregated food, water, and residential exposures result in aggregate MOEs of 498 for adult males and females. Adult residential exposure combines liquids/trigger sprayer/home garden with a high-end post-application dermal exposure from contact with treated lawns. EPA has concluded the combined intermediate-term aggregated food, water, and residential exposures result in an aggregate MOE of 137 for children. Children's residential exposure includes total exposures associated with contact with treated lawns (dermal and hand-to-mouth exposures). As the level of concern is for MOEs that are lower than 100, this MOE is not of concern.

5. Aggregate cancer risk for U.S. population. Based on a DEREK structural alert analysis, the lack of mutagenicity and the lack of specific organ toxicity in the chronic toxicity study, propanamide, 2-hydroxy-N, N-dimethyl- is not expected to pose a cancer risk to humans.

6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to propanamide, 2-hydroxy-N, N-dimethyl-.

An analytical method is not required for enforcement purposes since the Agency is not establishing a numerical tolerance for residues of propanamide, 2-hydroxy-N, N-dimethyl- in or on any food commodities. EPA is establishing a limitation on the amount of propanamide, 2-hydroxy-N, N-dimethyl- that may be used in pesticide formulations applied to growing crops. That limitation will be enforced through the pesticide registration process under the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”), 7 U.S.C. 136 et seq. EPA will not register any pesticide formulation for use on growing crops for sale or distribution that exceeds 50% by weight of propanamide, 2-hydroxy-N, N-dimethyl-.

The Agency received one relevant comment opposing a tolerance exemption for an increased concentration of 2-hydroxy-N, N-dimethyl- in pesticide formulations. Under the existing legal framework provided by FFDCA section 408, EPA is authorized to establish pesticide chemical tolerances or exemptions where persons seeking such tolerances or exemptions have demonstrated that the pesticide chemical meets the safety standard imposed by the statute. EPA has sufficient data to evaluate the potential adverse effects from exposure to this pesticide chemical, including data on the potential for long-term effects. After evaluating that data and other information, EPA has determined that the tolerance exemptions for this chemical are safe. The commenter has not provided any information supporting a conclusion that the tolerance exemption is not safe.

Therefore, the exemptions from the requirement of a tolerance under 40 CFR 180.910 and under 40 CFR 180.930 for residues of propanamide, 2-hydroxy-N, N-dimethyl- (CAS Reg. No. 35123-06-9) when used as an inert ingredient (solvent/co-solvent) are modified to allow use at a maximum concentration of 50% by weight in pesticide formulations applied to growing crops or raw agricultural commodities after harvest when used in pesticide formulations applied to animals, respectively.

This action amends exemptions to the requirement for a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), 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 exemptions in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ), do not apply.

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

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

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

Therefore, 40 CFR chapter I is amended as follows:

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

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

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-2018-0784 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing and must be received by the Hearing Clerk on or before April 14, 2020. 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-2018-0784, 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 April 19, 2019 (84 FR 16430) (FRL-9991-14), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 8E8715) by IR-4, IR-4 Project Headquarters, Rutgers, The State University of New Jersey, 500 College Road East, Suite 201W, Princeton, NJ 08540. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of acetamiprid, (1 E )- N -[(6-chloro-3-pyridinyl)methyl]- N ′-cyano- N -methylethanimidamide, including its metabolites and degradates in or on the following raw agricultural commodities: Tropical and subtropical, medium to large fruit, smooth, inedible peel, subgroup 24B at 0.50 parts per million (ppm); leafy greens subgroup 4-16A at 3.0 ppm; leaf petiole vegetable subgroup 22B at 3.0 ppm; celtuce at 3.0 ppm; Florence fennel at 3.0 ppm; Brassica, leafy greens, subgroup 4-16B at 15 ppm; Vegetable, Brassica, head and stem, group 5-16 at 1.2 ppm; kohlrabi at 1.2 ppm; fruit, stone, group 12-12 at 1.5 ppm; nut, tree, group 14-12 at 0.10 ppm; rapeseed subgroup 20A at 0.01 ppm; and cottonseed subgroup 20C at 0.70 ppm.

Additionally, the petition requested to amend 40 CFR 180.578 by removing the established tolerances for residues of acetamiprid in or on the following raw agricultural commodities: Vegetable, leafy, except Brassica, group 4 at 3.00 ppm; Brassica, leafy greens, subgroup 5B at 15 ppm; turnip, greens at 15 ppm; Brassica, head and stem, subgroup 5A at 1.20 ppm; fruit, stone, group 12, except plum, prune at 1.20 ppm; plum, prune, fresh at 0.20 ppm; nut, tree, group 14 at 0.10 ppm; pistachio at 0.10 ppm; canola, seed at 0.010 ppm; mustard, seed at 0.010 ppm; and cotton, undelinted seed at 0.60 ppm.

That document referenced a summary of the petition prepared by Nippon Soda Co., Ltd. c/o Nisso America Inc, the registrant, which is available in the docket, http://www.regulations.gov. Comments were received on the notice of filing. EPA's response to these comments is discussed in Unit IV.C.

Pursuant to its authority in FFDCA section 408(d)(4)(A)(i), EPA is establishing tolerances that vary slightly from what the petitioner requested. The reasons for these changes are 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 acetamiprid including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with acetamiprid 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.

In all species tested, generalized nonspecific toxicity was observed as decreases in body weight/body weight gain, food consumption, and food efficiency. Hepatocellular hypertrophy was observed in both mice and rats, and hepatocellular vacuolation in the rat, but these liver effects alone are considered adaptive and not indicative of an adverse effect. Other effects observed in the oral studies include amyloidosis of multiple organs in the mouse carcinogenicity study, tremors in high dose females in the mouse subchronic study, and micro-concretions in the kidney papilla and mammary hyperplasia in the rat chronic/carcinogenicity study.

Acetamiprid is rapidly absorbed, metabolized, and eliminated. The metabolism study in rats indicates 96-99% absorption following an oral administration. Peak blood concentrations in the rat occur within 1-2 hours at the low dose (1 mg/kg), 3-6 hours post-dosing at the high dose (50 mg/kg), and the main route of excretion is through the urine, which is nearly complete by 48 hours for all doses. Metabolites of acetamiprid account for 79-86% of the administered radioactivity, with 6-Chloronicotinic (IC-O) acid being the most abundant metabolite. There were no significant sex differences noted in the ADME profile in rats.

No effects were observed in the 21-day dermal study in the rabbit and no inhalation studies were conducted. EPA has used a refined value of 10% as a dermal absorption factor based on the rat dermal absorption study and weight of evidence.

Evidence of qualitative susceptibility was observed in the 2-generation reproductive study, with the offspring effects (significant reductions in pup weights, reduction in litter size and viability, significant delays in weaning indices and the age to attain vaginal opening and preputial separation) considered more severe than the decrease in parental body weights. Qualitative susceptibility was also seen in the developmental neurotoxicity study (DNT) with offspring effects (decreased body weight, pre-weaning survival, and startle response) occurring in the presence of marginal parental body weight decreases.

Evidence of neurotoxicity was observed in the rat acute neurotoxicity study (decrease in locomotor activity, and at higher doses: Tremors, difficulty in handling, walking on toes, dilated pupils, chewing, coldness to the touch, abnormal gaits and/or posture, decreased forelimb grip strength, and hind limb foot splay), subchronic toxicity study in mice (tremors), the DNT (decreased startle response), and comparative metabolism study (decreased alertness, reactivity, spontaneous activity, locomotor activity, rearing, muscle tone, and grip strength; as well as tremors, staggering, and depressed reflexes in the rat, mouse, and/or rabbit). Subchronic immunotoxicity studies were performed in both sexes in rats and mice, with no effects on the immune system observed up to the highest dose tested. Acetamiprid and its metabolites IC-0, IM-1-2, IM-1-4, IM-2-1, and IM-0 tested negative for mutagenicity. With no treatment-related tumors seen in rats or mice, the Agency has classified acetamiprid as not likely to be carcinogenic to humans.

Specific information on the studies received and the nature of the adverse effects caused by acetamiprid 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 “Acetamiprid. Human Health Risk Assessment for Proposed Use on Tropical and Subtropical, Medium to Large Fruit, Smooth, Inedible Peel Subgroup 24B; Greenhouse-grown Peppers; and Crop Group Conversions and Expansions” on pages 38-43 in docket ID number EPA-HQ-OPP-2018-0784.

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 acetamiprid used for human risk assessment is shown in Table 1 of this unit.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to acetamiprid, EPA considered exposure under the petitioned-for tolerances as well as all existing acetamiprid tolerances in 40 CFR 180.578. EPA assessed dietary exposures from acetamiprid 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 acetamiprid. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 2003-2008 National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in food, the acute dietary exposure assessment was unrefined and used tolerance-level residues and 100 percent crop treated (PCT).

ii. Chronic exposure. In conducting the chronic dietary exposure assessment, EPA used the food consumption data from the USDA 2003-2008 NHANES/WWEIA. As to residue levels in food, the chronic dietary exposure assessment was slightly refined using PCT information for some commodities. Aside from these commodities, the analyses were based on tolerance-level residues and the assumption of 100 PCT. In addition, conservative default processing factors were used for many processed commodities, while empirical processing factors were used for a limited number of processed commodities.

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

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

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

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

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

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

The Agency estimated the PCT for existing uses as follows:

In the acute assessment, 100 PCT was assumed for all commodities.

In the chronic assessment, the PCT estimates used were as follows: 1% of almonds, 30% of apples, 10% of apricots, 5% of asparagus, 10% of blueberries, 5% of broccoli, 10% of cabbage, 5% of caneberries, 15% of cantaloupes, 10% of cauliflower, 40% of celery, 5% of cherries, 5% of cotton, 2.5% of cucumbers, 2.5% of grapefruit, 2.5% of grapes, 2.5% of lemons, 15% of lettuce, 1% of nectarines, 2.5% of onions, 2.5% of oranges, 5% of peaches, 35% of pears, 1% of pecans, 5% of peppers, 5% of pistachios, 2.5% plums/prunes, 2.5% of potatoes, 5% of pumpkins, 10% of spinach, 5% of squash, 30% of strawberries, 1% of sweet corn, 5% of tomatoes, 15% of walnuts, and 5% of watermelons.

In most cases, EPA uses available data from United States Department of Agriculture/National Agricultural Statistics Service (USDA/NASS), proprietary market surveys, and California Department of Pesticide Regulation (CalDPR) Pesticide Use Reporting (PUR) for the chemical/crop combination for the most recent 10 years. EPA uses an average PCT for chronic dietary risk analysis and a maximum PCT for acute dietary risk analysis. The average PCT figure for each existing use is derived by combining available public and private market survey data for that use, averaging across all observations, and rounding to the nearest 5%, except for those situations in which the average PCT is less than 1% or less than 2.5%. In those cases, the Agency would use less than 1% or less than 2.5% as the average PCT value, respectively. The maximum PCT figure is the highest observed maximum value reported within the most recent 10 years of available public and private market survey data for the existing use and rounded up to the nearest multiple of 5%, except where the maximum PCT is less than 2.5%, in which case, the Agency uses less than 2.5% as the maximum PCT.

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

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

Based on the Pesticide in Water Calculator (PWC) and Provisional Cranberry Model, the estimated drinking water concentrations (EDWCs) of acetamiprid for acute exposures are estimated to be 88.1 parts per billion (ppb) in surface water and 211 ppb in ground water, and for chronic exposures are estimated to be 12.7 ppb in surface water and 175 ppb in 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 211 ppb was used to assess the contribution from drinking water. For the chronic dietary risk assessment, the water concentration of value 175 ppb was used to assess the contribution from 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).

Acetamiprid is currently registered for the following uses that could result in residential exposures: Gardens and trees, spot-on pet treatment, fly control, indoor crack/crevice, mattresses for bed bug control, and animal barns. EPA assessed residential exposure using the following assumptions: Residential handler dermal and inhalation exposure are expected to occur from the use of the registered acetamiprid formulations on ornamentals, vegetables, and fruit trees. All residential handler exposures are expected to be short-term in duration. Residential handler dermal exposure is expected to occur from the registered acetamiprid spot-on product when applied to dogs. Inhalation exposure from spot-on products is considered to be negligible. Residential handler dermal and inhalation exposures from applications to indoor environments was not assessed based on current Agency policy because the labels for the products that are used in indoor environments require personal protective equipment (PPE). Residential handler exposure from the fly bait use was not assessed, as exposures are expected to be insignificant due to incorporation of acetamiprid in the glue.

There is the potential for post-application exposure for individuals exposed as a result of being in an environment that has been treated with acetamiprid. The quantitative risk assessment for residential post-application exposures is based on the following scenarios: Short-term dermal exposure to gardens (gardens, trees, indoor plants); short-, intermediate-, and long-term dermal and incidental oral exposure to the dog spot-on treatment; short-term dermal, inhalation, and incidental oral exposure from the indoor crack and crevice and bed bug mattress uses; and short-term dermal and incidental oral exposure from the fly bait granule use. Post-application dermal exposures from foundation, perimeter, and spot treatments outdoors, along with post-application inhalation exposure, are considered negligible and were not assessed. Acetamiprid is also registered for use as a termiticide. A quantitative assessment for potential post-application inhalation and dermal exposure resulting from a commercial termiticide application in a residential setting is not needed, as all applications are made to the soil/foundation around/underneath a structure. In this case, exposure to acetamiprid vapors is not expected. Additionally, EPA believes that inhalation and dermal exposure to acetamiprid from bed bug treatments (applied directly to the space where people are living vs. application to the foundation/structure) would be protective of the termiticide uses of acetamiprid.

The lifestages selected for each post-application scenario are based on the Agency's 2012 Residential SOPs. While not the only lifestage potentially exposed for these post-application scenarios, the lifestage that is included in the quantitative assessment, ( i.e., Children (1 < 2 years), children (3 < 6 years), children (6 < 12 years), adult), is health protective for the exposures and risk estimates for any other potentially exposed lifestage.

Based on the proposed uses, short- and intermediate-term exposures are expected for the proposed use profile. Since the same endpoint and POD were selected for short- and intermediate-term durations, short-term exposure and risk estimates are considered protective of potential intermediate-term exposure and risk.

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 acetamiprid to share a common mechanism of toxicity with any other substances, and acetamiprid does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that acetamiprid 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. Evidence of qualitative susceptibility was observed in the 2-generation reproductive study, with the offspring effects (significant reductions in pup weights, reduction in litter size and viability, significant delays in weaning indices and the age to attain vaginal opening and preputial separation) considered more severe than the decrease in parental body weights. Qualitative susceptibility was also seen in the DNT with offspring effects (decreased body weight, pre-weaning survival, and startle response) occurring in the presence of marginal parental body weight decreases.

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 acetamiprid is complete.

ii. Acetamiprid produced signs of neurotoxicity in the high dose groups in the acute and developmental neurotoxicity studies in rats and the subchronic toxicity study in mice. However, no neurotoxic findings were reported in the subchronic neurotoxicity study in rats. Additionally, there are clear NOAELs identified for the effects observed in the toxicity studies. The doses and endpoints selected for risk assessment are protective and account for all toxicological effects observed in the database.

iii. No quantitative or qualitative evidence of increased susceptibility of fetuses to in utero exposure to acetamiprid was observed in the developmental toxicity study in either rats or rabbits. Although increased qualitative susceptibility was seen in the reproduction toxicity and the DNT study, the degree of concern for the effects is low. There are clear NOAELs for the offspring effects and regulatory doses were selected to be protective of these effects. No other residual uncertainties were identified with respect to susceptibility. The endpoints and doses selected for acetamiprid are protective of adverse effects in both offspring and adults.

iv. There are no residual uncertainties identified in the exposure databases. The acute dietary food exposure assessment was performed based on 100 PCT and tolerance-level residues, and the chronic dietary exposure assessment was slightly refined using PCT information for some commodities. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to acetamiprid in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by acetamiprid.

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 acetamiprid will occupy 89% of the aPAD for children 1 to 2 years old, the population group receiving the greatest exposure.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to acetamiprid from food and water will utilize 48% of the cPAD for children 1 to 2 years old, the population group receiving the greatest exposure.

Long-term aggregate risk assessments were conducted to assess risks for adults and children and include exposure through oral (children only) and dermal routes. The oral and dermal endpoints for long-term exposure durations are the same (decreased body weight and body weight gains), and therefore exposures from these pathways are aggregated. In accordance with the FQPA, the combined exposure from these pathways is added to the background dietary exposure from the chronic dietary exposure assessment.

The Agency selected only the most conservative, or worst case, scenarios for each lifestage. For both adults and children, worst-case long-term scenarios reflect post-application exposure to pets treated with spot-on products. As the LOCs are identical for all routes of exposure, and since the POD for all routes of exposure is derived from an oral study, the long-term aggregate MOEs were calculated by adding the exposures and dividing the POD (7.1 mg/kg) by the sum of the exposures.

EPA has concluded the combined long-term food, water, and residential exposures result in aggregate MOEs of 110 for children 1 to less than 2 years old and 360 for adults. Because EPA's level of concern for acetamiprid is a MOE of 100 or below, these MOEs are not of concern.

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).

Acetamiprid 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 acetamiprid.

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 180 for adults, 460 for children 6 to less than 12 years old, 340 for children 3 to less than 6 years old, and 130 for children 1 to less than 2 years old. Because EPA's level of concern for acetamiprid 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).

An intermediate-term adverse effect was identified, and intermediate-term exposure is expected; however, since the same endpoint and POD were selected for short- and intermediate-term durations, short-term exposure and risk estimates are considered protective of potential intermediate-term exposure and risk.

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

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

Approved tolerance enforcement methods for acetamiprid residues in crops are available, including methods using gas chromatography with electron capture detection (GC/ECD) analysis for vegetables and non-citrus fruits, high-performance liquid chromatography with ultraviolet detection (HPLC/UV) analysis for citrus fruits only, and HPLC with tandem mass spectrometric detection (LC/MS/MS) analysis for vegetables and non-citrus fruits. An approved HPLC/UV tolerance enforcement method for livestock matrices is available.

The methods 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: residuemethods@epa.gov.

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 following table summarizes the tolerances being established by this document and the corresponding Codex tolerances. The U.S. tolerance in Cottonseed subgroup 20C is harmonized with the Codex MRL in cotton seed. The U.S. tolerance in Fruit, stone, group 12-12 is harmonized with the Codex MRL in cherry, which has the highest MRL of the individual group 12-12 commodities with Codex MRLs. EPA is not able to harmonize the other tolerances with Codex MRLs because the U.S. tolerances are higher. Establishing a U.S. tolerance at a lower level to harmonize with Codex would put U.S. growers at risk of having violative residues despite legal use of the pesticide according to the label.

One commenter stated that “EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the pesticide petitions.” The commenter does not indicate what additional data might be necessary, why the commenter questions the sufficiency of the available data, or what about the Agency's findings is unsupported. Contrary to the commenter's position, the Agency has in fact fully evaluated all the data submitted on acetamiprid and determined that the toxicological and exposure databases on acetamiprid are complete, i.e., they do not contain any data gaps at this time, and dietary and residential exposure and risk have not been underestimated. Taking all that information into consideration, EPA has concluded that the tolerances for acetamiprid are safe.

The other comments submitted raised more general concerns about the use of pesticides and questioned a separate tolerance exemption. Neither raise issues relevant to this tolerance rulemaking.

EPA is establishing some of the tolerances at different levels than petitioned for in order to be consistent with the Agency's rounding class practice, which is based on the rounding procedures of the Organisation for Economic Co-operation and Development. EPA corrected the commodity definition for Fennel, Florence, fresh leaves and stalk. Finally, EPA is removing the existing tolerance in Plum, prune, dried, because it is no longer needed with the establishment of the tolerance in Fruit, stone, group 12-12; although not requested in the original petition, the need to remove this tolerance was confirmed in subsequent correspondence with the petitioner.

Therefore, tolerances are established for residues of acetamiprid in or on Brassica, leafy greens, subgroup 4-16B at 15 ppm; Celtuce at 3 ppm; Cottonseed subgroup 20C at 0.7 ppm; Fennel, Florence, fresh leaves and stalk at 3 ppm; Fruit, stone, group 12-12 at 1.5 ppm; Kohlrabi at 1.2 ppm; Leaf petiole vegetable subgroup 22B at 3 ppm; Leafy greens subgroup 4-16A at 3 ppm; Nut, tree, group 14-12 at 0.1 ppm; Rapeseed subgroup 20A at 0.01 ppm; Tropical and subtropical, medium to large fruit, smooth, inedible peel, subgroup 24B at 0.5 ppm; and Vegetable, brassica, head and stem, group 5-16 at 1.2 ppm.

Additionally, the following existing tolerances are removed as unnecessary due to the establishment of the above tolerances: Brassica, head and stem, subgroup 5A; Brassica, leafy greens, subgroup 5B; Canola, seed; Cotton, undelinted seed; Fruit, stone, group 12, except plum, prune; Mustard, seed; Nut, tree, group 14; Pistachio; Plum, prune, dried; Plum, prune, fresh; Turnip greens; and Vegetable, leafy, except brassica, group 4.

This action establishes and modifies 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 tolerances in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ), do not apply.

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

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

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

Therefore, 40 CFR chapter I is amended as follows:

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

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-2019-0129 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before April 14, 2020. 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-2019-0129, by one of the following methods:

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

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

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

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

In the Federal Register of June 7, 2019 (84 FR 26630) (FRL-9993-93), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-11245) by Syngenta Crop Protection, LLC, 410 Swing Road, P.O. Box 18300, Greensboro, NC 27419-8300. The petition requested the establishment of an exemption from the requirement of a tolerance for residues of ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl) propionate] (CAS Reg. No. 36443-68-2) when used as an inert ingredient (stabilizer) at no more than 1% by weight in pesticide formulations applied to or on raw agricultural commodities and growing crops under 40 CFR 180.910. That document referenced a summary of the petition prepared by Syngenta Crop Protection, LLC, the petitioner, which is available in the docket at http://www.regulations.gov. There were no comments received in response to the notice of filing.

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

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

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

Consistent with FFDCA section 408(c)(2)(A), and the factors specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl) propionate] including exposure resulting from the exemption established by this action. EPA's assessment of exposures and risks associated with ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl) propionate] follows.

EPA has evaluated the available toxicity data and considered their validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the adverse effects caused by ethylenebis(oxyethylene) bi[3-(5-tert-butyl-4-hydroxy-m-tolyl)propionate] as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are discussed in this unit.

Acute toxicity is low for ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl) propionate]. In rats, the lethal dose (LD 50 ) for acute oral and dermal toxicity is greater than 7,000 and 2,000 milligrams/kilogram/day (mg/kg/day), respectively. It is not a dermal or eye irritant, or a sensitizer.

Subchronic exposure to ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl) propionate] in rats resulted in increased liver weights and alanine aminotransferase (ALAT) activity at 112 mg/kg/day and minimal thyroid follicular hypertrophy at doses greater than 250 mg/kg/day. The NOAELs were 37.4 and 50 mg/kg/day, respectively. In dogs, no toxicity is seen at doses up to 300 mg/kg/day, the highest dose tested.

No fetal susceptibility was observed in the developmental studies. Maternal toxicity (reduced bodyweight gain and food consumption) occurs at 100 mg/kg/day while developmental toxicity (reduced bodyweight and delayed skeletal maturation) occurs at 300 mg/kg/day. The maternal NOAEL was not established, and the developmental NOAEL is 100 mg/kg/day.

Qualitative fetal susceptibility was observed in the 2-generation reproduction toxicity study. Pup mortality and reduced body weight were observed in offsprings at 900 parts per million (ppm) (~54 to 62 mg/kg/day). In parents, decreased bodyweight gain and food consumption occurred at the same dose. However, the established chronic reference dose (cRfD) of 0.15 mg/kg/day will be protective of offspring effects. The parental and offspring NOAELs are 300 ppm (~21 to 26 mg/kg/day). Reproduction toxicity was not observed up to 1,800 ppm (~108 to 124 mg/kg/day), the highest dose tested.

The combined chronic/carcinogenicity study showed focal cystic dilatation of the liver sinusoids and thyroid follicle hyperplasia at doses greater than 50 mg/kg/day. The NOAEL is 15 mg/kg/day. There was a treatment-related increase in thyroid tumor incidence at 100 mg/kg/day in both sexes. However, it is well established that alterations in rat thyroid hormones can alter the thyroid gland resulting in tumor formation. Based on the mechanistic studies, the postulated mode of action is that ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl) propionate] disrupts the rat thyroid-pituitary axis primarily through interference of peripheral T4 metabolism. The relevancy of thyroid tumors to man is limited, as rats are very sensitive to small changes in plasma T4 levels while humans are insensitive due to a number of physiological differences including the amount of thyroxin-binding globulin present, half-life of T4 between different species, and difference in responsiveness to thyrotropin releasing hormone. Therefore, the thyroid gland tumors observed in this study are not considered relevant to humans.

The Ames test, mammalian cell gene mutation and micronucleus assays were conducted with ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl) propionate]. These studies were negative; therefore, it is not expected to be mutagenic.

Neurotoxicity and immunotoxicity studies are not available for review. However, evidence of neurotoxicity and immunotoxicity is not observed in the submitted studies.

In a metabolism study in rats, ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl) propionate] administered orally is rapidly absorbed and metabolized. It is primarily excreted in the urine and feces. Metabolites were not identified in this study; however, it is a phenolic antioxidant and based on the classical metabolic pathway for this class of chemicals, it would be subject to glucuronide or sulphate conjugation, hydroxylation of the phenyl ring, and side chain oxidation. The resulting metabolites are expected to be 3-(3-tert-butyl-4-hydroxy-5-methyl-phenyl)propanoic acid and 2-[2-(2-hydroxyethoxy)ethoxy]ethanol (triethylene glycol).

Dermal absorption rate was calculated to be 0.53% in a dermal absorption study in miniature pigs.

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

The chronic/carcinogenicity toxicity study in rats was selected for all exposure scenarios. The NOAEL is 15 mg/kg/day, and the LOAEL is 50 mg/kg/day based on focal cystic dilatation of the liver sinusoids and thyroid follicle hyperplasia. This represents the lowest NOAEL in the database in the most sensitive species. However, in the developmental study, the maternal NOAEL is not established and the maternal LOAEL is 100 mg/kg/day based on decreased bodyweight gain and food consumption. Also, decreased bodyweight gain and food consumption are observed in parental animals at 900 ppm (~ 54 to 62 mg/kg/day) in the two-generation reproduction toxicity study, the NOAEL is 300 ppm (~ 21 to 26 mg/kg/day). Since, maternal and parental effects are the same in both studies, a parental NOAEL is established and treatment duration is longer in the two-generation reproduction toxicity study, it is considered adequate to address the lack of a maternal NOAEL in the developmental study. The standard inter- and intra-species uncertainty factors of 10x are applied; as discussed below in Unit IV.D., the Agency applied a 1X Food Quality Protection Act Safety Factor (FQPA) SF. The dermal absorption factor of 0.53% is applied based on a dermal absorption study in miniature pigs. The default factor of 100% is applied for the inhalation absorption rate.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl) propionate], EPA considered exposure under the proposed exemption from the requirement of a tolerance. EPA assessed dietary exposures from ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl) propionate] in food as follows:

No adverse effects attributable to a single exposure of endpoint was identified for ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl) propionate]; therefore, an acute dietary exposure assessment was not conducted.

In conducting the chronic dietary exposure assessment using the Dietary Exposure Evaluation Model DEEM-FCIDTM, Version 3.16, EPA used food consumption information from the U.S. Department of Agriculture's (USDA's) 2003-2008 National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in food, no residue data were submitted for ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl) propionate]. In the absence of specific residue data, EPA has developed an approach which uses surrogate information to derive upper bound exposure estimates for the subject inert ingredient. Upper bound exposure estimates are based on the highest tolerance for a given commodity from a list of high use insecticides, herbicides, and fungicides. A complete description of the general approach taken to assess inert ingredient risks in the absence of residue data is contained in the memorandum entitled “Alkyl Amines Polyalkoxylates (Cluster 4): Acute and Chronic Aggregate (Food and Drinking Water) Dietary Exposure and Risk Assessments for the Inerts,” (D361707, S. Piper, 2/25/09) and can be found at http://www.regulations.gov in docket ID number EPA-HQ-OPP-2008-0738.

In the dietary exposure assessment, the Agency assumed that the residue level of the inert ingredient would be no higher than the highest tolerance for a given commodity. Implicit in this assumption is that there would be similar rates of degradation (if any) between the active and inert ingredient and that the concentration of inert ingredient in the scenarios leading to these highest levels of tolerances would be no higher than the concentration of the active ingredient.

Although EPA is assessing ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl) propionate at 1.75% (to account for the requested 1% (by weight) limitation in pesticide formulations and up to 0.75% limitation for the FDA approved uses as an antioxidant and/or stabilizer for polymers used for food contact applications, the Agency believes the assumptions used to estimate dietary exposures lead to an very conservative assessment of dietary risk due to other conservative assumptions.

First, EPA assumes that, for each commodity, the active ingredient which will serve as a guide to the potential level of inert ingredient residues is the active ingredient with the highest tolerance level. This assumption overstates residue values because it would be highly unlikely, given the high number of inert ingredients, that a single inert ingredient or class of ingredients would be present at the level of the active ingredient in the highest tolerance for every commodity. Also, EPA's assumes that all foods contain the inert ingredient at the highest tolerance level. In other words, EPA assumed 100 percent of all foods are treated with the inert ingredient at the rate and manner necessary to produce the highest residue legally possible for an active ingredient. In summary, EPA chose a very conservative method for estimating what level of inert residue could be on food, then used this methodology to choose the highest possible residue that could be found on food and assumed that all food contained this residue. No consideration was given to potential degradation between harvest and consumption even though monitoring data shows that tolerance level residues are typically one to two orders of magnitude higher than actual residues in food when distributed in commerce.

Accordingly, although sufficient information to quantify actual residue levels in food is not available, the compounding of these conservative assumptions will lead to a significant exaggeration of actual exposures. EPA does not believe that this approach underestimates exposure in the absence of residue data.

2. Dietary exposure from drinking water. For the purpose of the screening level dietary risk assessment to support this request for an exemption from the requirement of a tolerance for ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl) propionate], a conservative drinking water concentration value of 100 ppb based on screening level modeling was used to assess the contribution to drinking water for the chronic dietary risk assessments for parent compound. These values were directly entered into the dietary exposure model.

3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure ( e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl)propionate] is registered for use as an inert ingredient in pesticide products that are registered for specific uses that may result in residential exposure, specifically lawn, turf, and garden use, and in indoor cleaning products. A conservative residential exposure and risk assessment was completed for pesticide products containing ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl) propionate] as inert ingredients. The Agency assessed ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl) propionate] in pesticide formulations (outdoor scenarios) and in disinfectant-type uses (indoor scenarios) at no more than 1% in the final formulation. The Agency's assessment of adult residential exposure combines high end dermal and inhalation handler exposure from indoor hard surface, aerosol spray with a high-end post application dermal exposure from contact with treated lawns. The Agency's assessment of children's residential exposure includes total post-application exposures associated with contact with treated surfaces (dermal and hand-to-mouth exposures).

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 ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl) propionate] to share a common mechanism of toxicity with any other substances, and ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl) propionate] does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl) propionate] 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://www.epa.gov/pesticides/cumulative.

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 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.

The Agency has concluded that there is reliable data to determine that infants and children will be safe if the FQPA SF of 10X is reduced to 1X for all exposure scenarios for the following reasons. The toxicity database for ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl) propionate] contains subchronic, developmental, reproduction, chronic/carcinogenicity, and mutagenicity studies. There is no indication of immunotoxicity or neurotoxicity in the available studies; therefore, there is no need to require an immunotoxicity or neurotoxicity study. Fetal susceptibility is not observed in developmental toxicity studies in the rat. Developmental toxicity (reduced fetal body weight and delayed skeletal maturation) occurred at a higher dose, 300 mg/kg/day, than maternal toxicity (reduced body weight gain), which occurred at 100 mg/kg/day. Qualitative fetal susceptibility toxicity is observed 2-generation reproduction toxicity study. Pup mortality and reduced pup body weight is observed at 900 ppm (~54-62 mg/kg/day), while parental toxicity is manifested as decreased bodyweight gain and food consumption at the same dose. However, the established cRfD of 0.15 mg/kg/day will be protective of any offspring effects seen at 900 ppm (~54-62 mg/kg/day). Therefore, there is no concern for fetal susceptibility. Reproduction toxicity is not observed up to 1,800 ppm (87-221 mg/kg/day), the highest dose tested. Based on the adequacy of the toxicity database, the conservative nature of the exposure assessment, and the lack of concern for prenatal and postnatal sensitivity, the Agency has concluded that there is reliable data to determine that infants and children will be safe if the FQPA SF of 10X is reduced to 1X.

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

1. Acute risk. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected. Therefore, ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl) propionate] is not expected to pose an acute risk.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl) propionate] from food and water will utilize 18.4% of the cPAD for children 1 to 2 years old, the population group receiving the greatest exposure.

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

Ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl) propionate] is currently used as an inert ingredient in pesticide products that are registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl) propionate].

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 1,235 for adult males and females. Adult residential exposure combines high-end dermal and inhalation handler exposure from indoor hard surface, aerosol spray with a high-end post-application dermal exposure from contact with treated lawns. The combined short-term aggregated food, water, and residential pesticide exposures result in an aggregate MOE of 511 for children. Children's residential exposure includes total exposures associated with contact with treated surfaces (dermal and hand-to-mouth exposures). Because EPA's level of concern for ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl) propionate] 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).

Ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl) propionate] is currently used as an inert ingredient in pesticide products that are registered for uses that could result in intermediate-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with intermediate-term residential exposures to ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl) propionate].

Using the exposure assumptions described in this unit for intermediate-term exposures, EPA has concluded that the combined intermediate-term food, water, and residential exposures result in aggregate MOEs of 1,729 for adult males and females. Adult residential exposure includes high-end post- application dermal exposure from contact with treated lawns. The combined intermediate-term aggregated food, water, and residential exposures result in an aggregate MOE of 413 for children. Children's residential exposure includes total exposures associated with contact with treated surfaces (dermal and hand-to-mouth exposures). Because EPA's level of concern for ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl) propionate] is a MOE of 100 or below, these MOEs are not of concern.]

5. Aggregate cancer risk for U.S. population. In a chronic/carcinogenicity study, thyroid gland tumors are observed at 100 mg/kg/day in rats. However, based on the postulated mode of action for these tumors, they are not considered relevant to humans. Also, ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl) propionate] is not mutagenic. Therefore, ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl) propionate] is not expected to pose a cancer risk to humans.

6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl) propionate] residues.

An analytical method is not required for enforcement purposes since the Agency is not establishing a numerical tolerance for residues of ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl) propionate] in or on any food commodities. EPA is establishing limitations on the amount of ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl) propionate] that may be used in pesticide formulations applied to growing crops and raw agricultural commodities after harvest. These limitations will be enforced through the pesticide registration process under the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”), 7 U.S.C. 136 et seq. EPA will not register any pesticide formulation for use on growing crops and raw agricultural commodities after harvest for sale or distribution that exceeds 1% by weight of ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl) propionate] unless additional data are submitted.

Therefore, an exemption from the requirement of a tolerance is established under 40 CFR 180.910 for ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl) propionate] (CAS Reg No. 36443-68-2) when used as an inert ingredient (stabilizer), limited to 1% (by weight) in pesticide formulations applied to growing crops and raw agricultural commodities after harvest.

This action establishes an exemption from the requirement of a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), 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 exemption in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ), do not apply.

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

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

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

Therefore, 40 CFR chapter I is amended as follows:

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 Publishing 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-2018-0718 and EPA-HQ-OPP-2019-0076 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before April 14, 2020. 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-2018-0718 and EPA-HQ-OPP-2019-0076, by one of the following methods:

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

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

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

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

In the Federal Register of June 7, 2019 (84 FR 26630) (FRL-9993-93) and in the Federal Register of May 9, 2019 (84 FR 20320) (FRL-9992-36), EPA issued documents pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 8F8695 and 8E8728, respectively) by Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, NC 27419. Pesticide petition 8F8695 requested that 40 CFR 180.475 be amended by establishing tolerances for residues of the fungicide difenoconazole in or on root vegetable crop subgroup 1A at 0.60 parts per million (ppm) and leaves of root and tuber vegetables crop group 2 at 8.0 ppm; PP 8E8728 requested the establishment of a tolerance for residues of difenoconazole in or on tea at 30 ppm. Those documents referenced summaries of the petitions prepared by Syngenta Crop Protection, LLC, the registrant, which are available in their respective dockets, http://www.regulations.gov. One comment was received on EPA's May 9, 2019 notice of filing in docket number EPA-HQ-OPP-2019-0076. EPA's response to this comment is discussed in Unit IV.C.

Based upon review of the data supporting the petition, EPA is establishing tolerances that vary from what the petitioner requested as permitted by FFDCA section 408(d)(4)(A)(i). These differences 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 difenoconazole including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with difenoconazole 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.

Subchronic and chronic toxicity studies with difenoconazole in mice and rats showed decreased body weights and effects on the liver ( e.g., hepatocellular hypertrophy, liver necrosis, fatty changes in the liver). No systemic toxicity was observed at the limit dose in a rat dermal toxicity study. Difenoconazole exhibits low acute toxicity by the oral, dermal and inhalation routes of exposure. It is not an eye or skin irritant and is not a sensitizer.

Acute and subchronic neurotoxicity studies showed evidence of mild neurotoxic effects. However, the selected endpoints of toxicity for risk assessment are protective of any potential neurotoxicity.

The available toxicity studies indicated no increased susceptibility of rats or rabbits from in utero or postnatal exposure to difenoconazole. In prenatal developmental toxicity studies in rats and rabbits and in the 2-generation reproduction study in rats, fetal and offspring toxicity, when observed, occurred at equivalent or higher doses than in the maternal and parental animals. In a rat developmental toxicity study, developmental effects were observed at doses higher than those which caused maternal toxicity. Developmental effects in the rat included increased incidence of ossification of the thoracic vertebrae and thyroid, decreased number of sternal centers of ossification, increased number of ribs and thoracic vertebrae, and decreased number of lumbar vertebrae. In the rabbit study, developmental effects (increases in post-implantation loss and resorptions and decreases in fetal body weight) were also seen at maternally toxic (decreased body weight gain and food consumption) doses. Since the developmental effects are more severe than the maternal effects, qualitative susceptibility is indicated in the rabbit developmental study; however, the selected POD is protective of this effect. In the 2-generation reproduction study in rats, toxicity to the fetuses and offspring, when observed, occurred at equivalent or higher doses than in the maternal and parental animals.

Although there is some evidence that difenoconazole affects antibody levels at doses that cause systemic toxicity, there are no indications in the available studies that organs associated with immune function, such as the thymus and spleen, are affected by difenoconazole. Difenoconazole is not mutagenic or genotoxic, and no evidence of carcinogenicity was seen in rats. Evidence for carcinogenicity was seen in mice as induction of liver tumors at doses which were considered to be excessively high for carcinogenicity testing. Difenoconazole has been classified as “Suggestive Evidence of Carcinogenic Potential” based on liver tumors observed in mice. EPA has concluded that the chronic point of departure (POD) for assessing chronic risk will be protective of any cancer effects for the following reasons: (1) Tumors were seen in only one species; (2) carcinoma tumors were observed only at the two highest doses in the mouse carcinogenicity study; (3) benign tumors and necrosis were observed at the mid-dose; (4) the absence of tumors at the study's lower doses; (5) the absence of genotoxic or mutagenic effects. The cRfD is well below the no-observed- adverse-effect-level (NOAEL) of the mouse carcinogenicity study, at which no effects on the biological endpoints relevant to tumor development ( i.e., hepatocellular hypertrophy, liver necrosis, fatty changes in the liver and bile stasis) were seen. As a result, EPA has concluded that a nonlinear RfD approach is appropriate for assessing cancer risk to difenoconazole and a separate quantitative cancer exposure assessment is unnecessary.

Specific information on the studies received and the nature of the adverse effects caused by difenoconazole as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document “Difenoconazole. Human Health Risk Assessment for Proposed New Foliar Uses on All Members of Vegetable, Root, Subgroup 1A and Vegetable, Leaves of Root and Tuber, Group 2 and Establishment of a Tolerance with No U.S. Registration in/on Imported Tea” in docket ID number EPA-HQ-OPP-2018-0718.

Once a pesticide's toxicological profile is determined, EPA identifies toxicological POD and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the NOAEL and 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 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 difenoconazole used for human risk assessment is shown in Table 1 of this unit.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to difenoconazole, EPA considered exposure under the petitioned-for tolerances as well as all existing difenoconazole tolerances in 40 CFR 180.475. EPA assessed dietary exposures from difenoconazole 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 difenoconazole. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA) 2003 to 2008. As to residue levels in food, EPA assumed tolerance-level residues, 100 percent crop treated (PCT), and available empirical or default processing factors.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA NHANES/WWEIA 2003 to 2008. As to residue levels in food, EPA used tolerance-level residues for some commodities, average field trial residues and USDA Pesticide Data Program monitoring samples for the remaining commodities, available empirical or default processing factors, and average PCT assumptions for some commodities.

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

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

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

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

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

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

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

The Agency estimated the PCT for existing uses as follows: Almond 15%, apples 25%, apricot 10%, artichoke 15%, blueberry 10%, broccoli 2.5%, cabbage 10%, cantaloupe 2.5%, carrot 2.5%, cauliflower 2.5%, cherry 2.5%, cucumbers 5%, garlic 10%, grapefruit 10%, grape (raisin) 10%, grape (table) 25%, grape (wine) 15%, hazelnut 2.5%, lemon 5%, onions 10%, orange 5%, peach 10%, pear 10%, pecan 5%, peppers 15%, pistachio 10%, plum/prune 10%, potato 20%, pumpkin 5%, soybean 2.5%, squash 10%, strawberry 2.5%, sugar beets 20%, sweet corn 5%, tangerine 5%, tomato 35%, walnut 5%, watermelon 15%, and wheat 15%.

In most cases, EPA uses available data from United States Department of Agriculture/National Agricultural Statistics Service (USDA/NASS), proprietary market surveys, and California Department of Pesticide Regulation (CalDPR) Pesticide Use Reporting (PUR) for the chemical/crop combination for the most recent 10 years. EPA uses an average PCT for chronic dietary risk analysis. The average PCT figures for each existing use is derived by combining available public and private market survey data for that use, averaging across all observations, and rounding up to the nearest 5%, except for those situations in which the average PCT is less than 1% or less than 2.5%. In those cases, the Agency would use less than 1% or less than 2.5% as the average PCT value, respectively. The maximum PCT figure is the highest observed maximum value reported within the most recent 10 years of available public and private market survey data for the existing use and rounded up to the nearest multiple of 5%, except where the maximum PCT is less than 2.5%, in which case, the Agency uses less than 2.5% as the maximum PCT.

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

2. Dietary exposure from drinking water. The drinking water assessment was performed using a total toxic residue method, which considers both parent difenoconazole and its major metabolite, CGA 205375, or total toxic residues (TTR) from difenoconazole uses, in surface and groundwater. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for difenoconazole in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of difenoconazole plus CGA 205375. 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 Tier II Pesticide in Water Calculator (PWC v1.52) model and Tier 1 Rice Model, the estimated drinking water concentrations (EDWCs) of TTR of difenoconazole for acute exposures are estimated to be 33.4 parts per billion (ppb) for surface water and 2.0 ppb for ground water. Chronic exposure EDWCs for non-cancer assessments are estimated to be 27.4 ppb for surface water and 0.60 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 33.4 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 27.4 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). Difenoconazole is currently registered for the following uses that could result in residential exposures: Treatment of ornamental plants in commercial and residential landscapes and interior plantscapes as well as turf applications to golf courses. EPA assessed residential exposure using the following assumptions: For residential handlers, adult short-term dermal and inhalation exposure is expected from mixing, loading, and applying difenoconazole on ornamentals (gardens and trees). For residential post-application exposures, short-term dermal exposure is expected for both adults and children (6 < 11 years old and 11 < 16 years old) from post-application activities in treated residential landscapes and on golf courses. There are no residential uses for difenoconazole that would result in incidental oral exposure to children.

The scenarios used in the aggregate assessment were those that resulted in the highest exposures. The highest exposures consist of the short-term dermal exposure to adults from post-application activities in treated gardens and short-term dermal exposure to children 6 to 11 years old from post-application activities in treated gardens. 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.”

Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to difenoconazole and any other substances, although EPA has previously concluded that there are no conclusive data that difenoconazole shares a common mechanism of toxicity with other conazole pesticides. Although the conazole fungicides (triazoles) produce 1,2,4 triazole and its acid-conjugated metabolites (triazolylalanine and triazolylacetic acid), 1,2,4 triazole and its acid-conjugated metabolites do not contribute to the toxicity of the parent conazole fungicides (triazoles). A separate aggregate risk assessment was conducted for triazole and the conjugated triazole metabolites ( Common Triazole Metabolites: Updated Aggregate Human Health Risk Assessment to Address New Section 3 Registrations For Use of Difenoconazole and Mefentrifluconazole; DP451447, dated May 15, 2019) and it can be found at https://www.regulations.gov at docket ID number EPA-HQ-OPP-2018-0002. These new uses of difenoconazole considered with existing uses of triazole compounds do not result in a risk of concern for 1,2,4-trizaole and its metabolites. Difenoconazole does not appear to produce any other toxic metabolite produced by other substances. For the purposes of this action, therefore, EPA has not assumed that difenoconazole has 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 https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the 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. The available toxicity studies indicated no increased quantitative susceptibility of rats or rabbits from in utero or postnatal exposure to difenoconazole. In prenatal developmental toxicity studies in rats and rabbits and in the 2-generation reproduction study in rats, fetal/offspring toxicity, when observed, occurred at equivalent or higher doses than in the maternal/parental animals. In rabbits there was qualitative susceptibility since the developmental effects were more severe than the maternal effects seen at the same dose; however, the selected POD is protective of this effect. In a rat developmental toxicity study, developmental effects were observed at doses higher than those which caused maternal toxicity. Developmental effects in the rat included increased incidence of ossification of the thoracic vertebrae and hyoid, decreased number of sternal centers of ossification, increased number of ribs and thoracic vertebrae, and decreased number of lumbar vertebrae. In the rabbit study, developmental effects (increases in post-implantation loss and resorptions and decreases in fetal body weight) were also seen at maternally toxic (decreased body weight gain and food consumption) doses. In the two-generation reproduction study in rats, toxicity to the fetuses/offspring (reduction in the body weight of F1 male pups), when observed, occurred at equivalent or higher doses than in the maternal/parental animals (reductions in body weight gain).

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 difenoconazole is sufficient for a full hazard evaluation and is considered adequate to evaluate risks to infants and children.

ii. There are no clear signs indication that difenoconazole is a neurotoxic chemical following acute, subchronic, or chronic dosing in multiple species in the difenoconazole database. The effects observed in acute and subchronic neurotoxicity studies are considered non-adverse as they were transient in nature and were only observed in one sex (males as reduced fore-limb grip strength with no histologic findings) and the selected endpoints of toxicity for risk assessment are protective of any potential neurotoxicity. There is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.

iii. There is no evidence that difenoconazole results in increased quantitative susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study. However, in the developmental toxicity study in rabbits, developmental effects (increases in post-implantation loss and resorptions and decreases in fetal body weight) were also seen at maternally toxic doses (decreased body weight gain and food consumption). Because these effects are more severe, qualitative susceptibility is evident in the rabbit. The PODs selected to assess dietary exposures are protective of these effects.

iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on tolerance-level residues and 100% CT for the acute assessment while the chronic assessment used USDA Pesticide Data Program (PDP) monitoring data, average field trial residues for some commodities, tolerance level residues for remaining commodities, and average percent crop treated for some commodities. These assumptions will not underestimate dietary exposure to difenoconazole. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to difenoconazole 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 difenoconazole.

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

1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to difenoconazole will occupy 52% of the aPAD for all infants <1 year old, the population group receiving the greatest exposure.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to difenoconazole from food and water will utilize 53% of the cPAD for all infants <1 year 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 difenoconazole is not expected.

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

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 180 for adults and 240 for children 6 to <11 years old. Because EPA's level of concern for difenoconazole is an 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). An intermediate-term adverse effect was identified; however, difenoconazole 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 difenoconazole.

5. Aggregate cancer risk for U.S. population. As discussed in Unit III.A., EPA has determined that use of the chronic reference dose will be protective of the potential for cancer risk. Because the chronic exposure does not exceed the Agency's level of concern, EPA concludes that exposure to difenoconazole would not pose an unacceptable cancer risk.

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

An adequate tolerance enforcement method, gas chromatography with nitrogen-phosphorus detection (GC/NPD) method AG-575B, is available for the determination of residues of difenoconazole in/on plant commodities. An adequate enforcement method, gas chromatography with mass spectrometry detection (GC/MSD) method AG-676A, is also available for the determination of residues of difenoconazole per se in/on canola and barley commodities. A confirmatory method, GC/MSD method AG-676, is also available.

An adequate tolerance enforcement method, Method REM 147.07b, is available for livestock commodities. The method determines residues of difenoconazole and CGA-205375 in livestock commodities by liquid chromatography with tandem mass spectrometry detection (LC-MS/MS). Adequate confirmatory methods, Method AG-544A and Method REM 147.06, are available for the determination of residues of difenoconazole and CGA-205375, respectively, in livestock commodities.

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: residuemethods@epa.gov.

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.

Codex has established MRLs for difenoconazole in or on carrot at 0.2 ppm; edible offal at 1.5 ppm; sugar beet at 0.2 ppm; ginseng at 0.08 ppm; ginseng, dried at 0.8 ppm; and ginseng, extracts at 0.6 ppm. Several of these MRLs are different than the tolerances established for difenoconazole in the United States. The U.S. tolerance in/on crop subgroup 1A, except ginseng (0.6 ppm), being established in this rulemaking, is based on radish root data and cannot be harmonized with the Codex MRL for carrot, which is lower than the subgroup tolerance; doing so could result in exceedances of the tolerances even when growers followed label directions. The U.S. tolerance for ginseng has been harmonized with the Codex MRL for ginseng, dried and is inclusive of the lower tolerances for ginseng and ginseng, extracts. The tolerances for cattle, liver; goat, liver; horse, liver; and sheep, liver cannot be harmonized with Codex MRLs due to different dietary burdens.

EPA received one comment opposing pesticide residues in food, although no substantive information was provided for EPA to take into consideration in its safety assessment. Although the commenter generally expressed concern about the potential for exposure to difenoconazole to be carcinogenic, EPA has evaluated the available data on carcinogenicity and exposure and determined that aggregate exposure to difenoconazole will not cause a cancer risk. The FFDCA authorizes EPA to establish tolerances that permit certain levels of pesticide residues in or on food when the Agency can determine that such residues are safe. EPA has made that determination for the tolerances subject to this action; the commenter provided no information relevant to that conclusion.

The terms “tea;” “root vegetable crop subgroup 1A;” “leaves of root and tuber vegetables crop group 2” requested in the petition are being replaced with “tea, dried;” “vegetable, root, subgroup 1A, except ginseng;” and “vegetable, leaves of root and tuber, group 2”, respectively, to reflect the correct commodity definitions. The EPA has modified the tolerance on tea, dried from the requested 30 ppm to 15 ppm to harmonize with Japan's draft MRL. The ginseng tolerance has been removed from the vegetable, root, subgroup 1A and set at 0.8 to harmonize with the highest Codex MRL. Tolerances for cattle, liver; goat, liver; horse, liver; and sheep, liver have been increased from 0.40 to 0.7 ppm based on the re-calculated dairy cattle dietary burden and the available feeding study data for residues of difenoconazole and its metabolite CGA-205375. Trailing zeroes have been removed from tolerances in accordance with current Agency practices.

In this final rule, EPA is reducing the existing tolerance for ginseng from 1.0 ppm to 0.8 ppm in order to harmonize with the Codex MRL. Available residue data demonstrates that the new tolerance is sufficient to cover residues on ginseng.

In accordance with the World Trade Organization's (WTO) Sanitary and Phytosanitary Measures (SPS) Agreement, EPA intends to notify the WTO of this revision in order to satisfy its obligation. In addition, the SPS Agreement requires that Members provide a “reasonable interval” between the publication of a regulation subject to the Agreement and its entry into force to allow time for producers in exporting Member countries to adapt to the new requirement. At this time, EPA is establishing an expiration date for the existing ginseng tolerance to allow that tolerance to remain in effect for a period of six months after the effective date of this final rule, in order to address this requirement. After the six month period expires, residues of difenoconazole on ginseng cannot exceed the new tolerance of 0.8 ppm.

This reduction in tolerance levels is not discriminatory; the same food safety standard contained in the FFDCA applies equally to domestically produced and imported foods. The new tolerance levels are supported by available residue data.

Therefore, tolerances are established for residues of difenoconazole, difenoconazole, in or on vegetable, root, subgroup 1A, except ginseng at 0.6ppm; vegetable, leaves of root and tuber, group 2 at 8 ppm; and tea, dried at 15 ppm. Tolerances are amended for ginseng from 1.0 to 0.8 ppm; and cattle, liver; goat, liver; horse, liver; and sheep, liver from 0.40 ppm to 0.7 ppm. In addition, the Agency is removing the existing tolerances for beet, sugar; and carrot as they are unnecessary upon the establishment of the tolerance for vegetable, root, subgroup 1A, except ginseng. Finally, the Agency is amending the existing tolerance for ginseng by adding an expiration date.

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:

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

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2017-0694 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing and must be received by the Hearing Clerk on or before April 14, 2020. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2017-0694, by one of the following methods:

• Federal eRulemaking Portal: https://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 https://www.epa.gov/dockets/where-send-comments-epa-dockets.

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

In the Federal Register of August 2, 2019 (84 FR 37818) (FRL-9996-78), 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 9E8739) by The Interregional Research Project No. 4 (IR-4), Rutgers, The State University of New Jersey, 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40 CFR 180.672 be amended by establishing a tolerance for residues of the insecticide, cyantraniliprole, 3-bromo-1-(3-chloro-2-pyridinyl)-N-[4-cyano-2-methyl-6-[((methylamino)carbonyl]phenyl]-1H-pyrazole-5-carboxamide, in or on strawberry at 1.5 parts per million (ppm). Upon the establishment of the above tolerance, IR-4 proposed to remove the existing tolerance in 40 CFR 180.672 in or on strawberry at 1.0 ppm. That document referenced a summary of the petition prepared by DuPont Crop Protection, the registrant, which is available in the docket, https://www.regulations.gov. No comments were received on the notice of filing.

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 cyantraniliprole including exposure resulting from the tolerance established by this action. EPA's assessment of exposures and risks associated with cyantraniliprole 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.

A summary of the toxicological profile for cyantraniliprole is discussed in Unit III.A. of the final rule published in the Federal Register of November 13, 2018 (84 FR 56262) (FRL-9985-32). A summary of the toxicological endpoints for cyantraniliprole used for human risk assessment is discussed in Unit III.B of the final rule published in the Federal Register of February 5, 2014 (79 FR 6826) (FRL-9388-7).

Specific information on the studies received and the nature of the adverse effects caused by cyantraniliprole as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document “Cyantraniliprole. Human Health Risk Assessment for Proposed Uses and Tolerance Requests on Coffee; Caneberry Subgroup 13-07A; Low Growing Berry Subgroup 13-07H, Except Strawberry, Lowbush Blueberry and Lingonberry; Brassica Leafy Greens Subgroup 4-16A; Leafy Greens Subgroup 4-16B; Brassica Head and Stem Vegetable Group 5-16; Leaf Petiole Vegetable Subgroup 22B; Celtuce; Florence Fennel; Kohlrabi; Rice; Soybean; and Aspirated Grain Fractions” on pages 36-45 in docket ID number EPA-HQ-OPP-2017-0694.

A summary of EPA's consideration of dietary exposure under the petitioned-for tolerance as well as existing cyantraniliprole tolerances, as well as non-dietary exposure and exposure to substances with a common mechanism of toxicity is discussed in Unit III.C. of the November 13, 2018 final rule published in the Federal Register .

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.

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 findings summarized in Unit III.D. of the November 13, 2018 final rule.

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

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

2. Chronic risk. Using the exposure assumptions cited in this unit for chronic exposure, EPA has concluded that chronic exposure to cyantraniliprole from food and water will utilize 99% of the cPAD for children 1 to 2 years old, the population group receiving the greatest exposure. Based on the explanation cited in Unit III.B., regarding residential use patterns, chronic residential exposure to residues of cyantraniliprole 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). Cyantraniliprole 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 cyantraniliprole.

Using the exposure assumptions cited in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in an aggregate MOE of 149 for children 1 to 2 years old. For adults, the oral and inhalation routes of exposure are not appropriate to be aggregated since the endpoints of concern are not common. Because EPA's level of concern for cyantraniliprole is an MOE of 100 or below, this MOE is not of concern.

4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Cyantraniliprole is currently registered for uses that could result in intermediate-term residential exposure, however, the short-term aggregate risk estimate described above is protective of potential intermediate-term exposures and risks in children.

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

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

Adequate enforcement methodology (liquid chromatography with tandem mass spectroscopy (LC/MS/MS)) is available to enforce the tolerance expression.

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

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.

Codex has not established an MRL for cyantraniliprole residues in or on strawberry.

Therefore, the existing tolerance for residues of cyantraniliprole, 3-bromo-1-(3-chloro-2-pyridinyl)-N-[4-cyano-2-methyl-6-[((methylamino)carbonyl]phenyl]-1H-pyrazole-5-carboxamide, in or on strawberry is modified from 1.0 ppm to 1.5 ppm.

This action modifies a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), 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:

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 Publishing 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-2018-0785 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before April 14, 2020. 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-2018-0785, 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 April 19, 2019 (84 FR 16430) (FRL-9991-14), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 8E8716) by IR-4, IR-4 Project Headquarters, Rutgers, The State University of New Jersey, 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40 CFR 180.547 be amended by establishing tolerances with regional registrations in Wisconsin and Pennsylvania for residues of prohexadione calcium (calcium 3-oxido-5-oxo-4-propionylcyclohex-3-enecarboxylate) in or on the raw agricultural commodities corn, field, forage at 0.10 parts per million (ppm); corn, field, grain at 0.10 ppm; corn, field, stover at 0.10 ppm; alfalfa, forage at 0.10 ppm; and alfalfa, hay at 0.10 ppm. That document referenced a summary of the petition prepared by Fine Agrochemicals, Ltd., the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

EPA is establishing the requested tolerances, although the tolerance values have been adjusted to be consistent with Organization for Economic Cooperation and Development (OECD) Rounding Class Practice.

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 prohexadione calcium including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with prohexadione calcium 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.

By the oral route, the most sensitive effect in the prohexadione calcium hazard database is kidney toxicity in dogs for both the subchronic and chronic durations. Minor hematological changes (decreased white blood cell counts in males), and fore-stomach hyperplasia were seen only at very high doses in rodents. No dermal toxicity was observed up to the limit dose of 1000 mg/kg/day.

In rats and rabbits, no increased quantitative or qualitative pre- or postnatal susceptibility was observed. In rats, no maternal or developmental toxicity was observed up to the limit dose (1000 mg/kg/day). Three developmental studies in rabbits are available in the toxicological database for prohexadione calcium. In one study, late abortions occurred during gestational days (GD) 24-29 at 200 mg/kg/day, with increased mortality in maternal animals (GD 15-24) also noted at this dose. In another rabbit developmental study, two premature deliveries (on GD 24 and 26) were noted at the highest-dose tested (350 mg/kg/day) with no developmental effects observed. No maternal or developmental effects were seen in a third rabbit developmental study up to 150 mg/kg/day. In the 2-generation reproductive toxicity study with rats, parental toxicity (minimal mortality) occurred at a dose well below the dose that caused decreases in offspring body weight.

There is no evidence of neurotoxicity in the toxicological database for prohexadione calcium, which includes acute and subchronic neurotoxicity studies.

Prohexadione calcium is classified as not likely to be carcinogenic to humans based on lack of evidence of carcinogenicity in rats and mice.

Specific information on the studies received and the nature of the adverse effects caused by prohexadione calcium 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 “Prohexadione Calcium. Section 3 Registration for Use on Strawberry and Watercress. Human Health Risk Assessment” on pages 26-28 in docket ID number EPA-HQ-OPP-2018-0785.

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-pesticide.

A summary of the toxicological endpoints for prohexadione calcium used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of July 8, 2015 (80 FR 38976) (FRL-9927-25).

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to prohexadione calcium, EPA considered exposure under the petitioned-for tolerances as well as all existing prohexadione calcium tolerances in 40 CFR 180.547. EPA assessed dietary exposures from prohexadione calcium in food as follows:

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

No such effects were identified in the toxicological studies for prohexadione calcium; therefore, a quantitative acute dietary exposure assessment is unnecessary.

ii. Chronic exposure. In estimating chronic dietary exposure, EPA used 2003-2008 food consumption information from the U.S. 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, the chronic assessment was based on tolerance-level residues and 100 percent crop treated (PCT).

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

iv. Anticipated residue and PCT information. EPA did not use anticipated residue or PCT information in the dietary assessment for prohexadione calcium. 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 prohexadione calcium in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of prohexadione calcium. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.

Based on the Pesticide in Water Calculator (PWC), the estimated drinking water concentrations (EDWCs) of prohexadione calcium for chronic exposures are estimated to be 29 ppb for surface water and 5.1 × 10 − 7 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For the chronic dietary risk assessment, the water concentration of value 29 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).

Prohexadione calcium is currently registered for the following uses that could result in residential exposures: Residential lawns, ornamentals, athletic fields, parks, and golf courses. EPA assessed residential exposure using the following assumptions: Residential handler exposure is not expected because all registered labels require the use of personal protective equipment (PPE) and are not intended for application by homeowners. Short-term exposure was assessed for post-application incidental oral exposures of children 1 to less than 2 years old. The Agency assessed hand-to-mouth exposures and incidental soil ingestion from applications to turf for children. Intermediate- and long-term exposures are not expected since there are no registered or proposed uses of prohexadione calcium that result in intermediate- or long-term residential exposures.

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 prohexadione calcium to share a common mechanism of toxicity with any other substances, and prohexadione calcium does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that prohexadione calcium 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. In rats and rabbits, no increased quantitative or qualitative pre- or postnatal susceptibility was observed. In the 2-generation reproductive toxicity study with rats, parental toxicity (minimal mortality) occurred at a dose well below the dose that caused decreases in offspring body weight.

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 prohexadione calcium is complete.

ii. There is no indication that prohexadione calcium is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.

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

iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessment was 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 prohexadione calcium in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by prohexadione calcium.

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

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

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to prohexadione calcium from food and water will utilize 17% of the cPAD for children 1 to 2 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 prohexadione calcium 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).

Prohexadione calcium 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 prohexadione calcium.

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 an aggregate MOE of 2,300 for children 1 to less than 2 years old. Because EPA's level of concern for prohexadione calcium is an MOE below 100, this MOE is not of concern.

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

An intermediate-term adverse effect was identified; however, prohexadione calcium 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 prohexadione calcium.

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

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

Adequate enforcement methodology (gas chromatography/mass-selective detector (GC/MSD) and liquid chromatography with tandem mass spectroscopy (LC-MS/MS)) is available to enforce the tolerance expression.

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

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

The Codex has not established MRLs on alfalfa or corn for prohexadione calcium.

Therefore, tolerances with regional registration are established for residues of prohexadione calcium in or on alfalfa, forage at 0.1 ppm; alfalfa, hay at 0.1 ppm; corn, field, forage at 0.1 ppm; corn, field, grain at 0.1 ppm; and corn, field, stover at 0.1 ppm.

This action establishes and modifies 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 tolerances in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ), do not apply.

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

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

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

Therefore, 40 CFR chapter I is amended as follows:

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

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Publishing 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-2018-0297 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before April 14, 2020. 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-2018-0297, 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 July 24, 2018 (83 FR 34968) (FRL-9980-31), 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 8F8661) by Cheminova A/S, on behalf of FMC Corporation, 2929 Walnut Street, Philadelphia, PA 19104. The petition requested that 40 CFR 180.629 be amended by establishing tolerances for residues of the fungicide flutriafol, ((±)-α-(2-fluorophenyl-α-(4-fluorophenyl)-1H-1,2,4-triazole-1-ethanol), in or on alfalfa, forage at 15.0 parts per million (ppm); alfalfa, hay at 50 ppm; barley, grain at 1.5 ppm; barley, hay at 7.0 ppm; barley, straw at 8.0 ppm; corn, sweet, forage at 9.0 ppm; corn, sweet kernels plus cobs with husks removed at 0.03 ppm; corn, sweet, stover at 8 ppm; rice, bran at 0.4 ppm; rice, grain at 0.5 ppm; rice, hulls at 1.5 ppm; rice, straw at 0.9 ppm. Although the Agency's document did not expressly include the following, the petition also requested the removal of the following tolerances upon establishment of the petitioned-for tolerances: Existing tolerances for inadvertent or indirect residues of flutriafol in corn, sweet, forage at 0.09 ppm; corn, sweet, kernels plus cobs with husks removed at 0.01 ppm; and corn, sweet, stover at 0.07 ppm. That document referenced a summary of the petition prepared by Cheminova A/S on behalf of FMC Corporation, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

Based upon review of the data supporting the petition, EPA is issuing some tolerances that vary from what the petitioner requested. The reason for these changes are explained in Unit IV.D.

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

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

Consistent with the mammalian toxicity profiles of the other triazole fungicides, the prevalent adverse effects following oral exposure to flutriafol were in the liver. Effects consisted of increases in liver enzyme release (alkaline phosphatase), liver weights, and histopathology findings (hepatocyte vacuolization to centrilobular hypertrophy and slight increases in hemosiderin-laden Kupffer cells, minimal to severe fatty changes, and bile duct proliferation/cholangiolar fibrosis). Progression of toxicity occurred with time as some effects were only observed at chronic durations.

Slight indications of effects in the hematopoietic system were sporadically seen in all species consisting of slight anemia, increased platelets, white blood cells, neutrophils, and lymphocytes. The effects in the neurotoxicity screening batteries were observed only at higher doses and were considered secondary effects (decreased motor activity and hindlimb grip strength, ptosis, lost righting reflex, hunched posture, and ataxia). Flutriafol showed no evidence of dermal toxicity, or immunotoxicity. Flutriafol showed no evidence of carcinogenicity in rodents or in vitro.

There is evidence of increased quantitative and qualitative prenatal and postnatal susceptibility for flutriafol in rats and rabbits. In the first of two rat developmental toxicity studies, developmental effects (delayed ossification or non-ossification of the skeleton in the fetuses) were observed at a lower dose than that where maternal effects were observed. In the second rat developmental study, developmental effects (external, visceral, and skeletal malformations; embryo lethality; skeletal variations; a generalized delay in fetal development; and fewer live fetuses) were more severe than the decreased food consumption and body-weight gains observed in the dams at the same dose. For rabbits, intrauterine deaths occurred at a dose level that also caused adverse effects in maternal animals. In the 2-generation reproduction studies, effects in the offspring [decreased litter size and percentage of live births (increased pup mortality) and liver toxicity] can be attributed to the systemic toxicity of the parental animals (decreased body weight and food consumption and liver toxicity) observed at the same dose.

Flutriafol is categorized as having high oral acute toxicity in the mouse. It is categorized as having low acute toxicity via the oral, dermal and inhalation routes in rats. Flutriafol is minimally irritating to the eyes and is not a dermal irritant. Flutriafol was not shown to be a skin sensitizer when tested in guinea pigs.

Specific information on the studies received and the nature of the adverse effects caused by flutriafol as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document “Human Health Risk Assessment in Support of a Section 3 Registration for Application to Alfalfa, Barley, Sweet Corn, Rice (as a Rotated Crop), Turf, and Ornamentals at 18” in docket ID number EPA-HQ-OPP-2018-0297.

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 flutriafol used for human risk assessment is shown in Table 1 of this unit.

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

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Publishing 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-2018-0783 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before April 14, 2020. 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-2018-0783, by one of the following methods:

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

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

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

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

In the Federal Register of March 18, 2019 (84 FR 9737) (FRL-9989-71), 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 8E8717) by IR-4 Headquarters, 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40 CFR 180.513 be amended by establishing tolerances for residues of the insecticide chlorfenapyr, 4-bromo-2-(4-chlorophenyl)-1-(ethoxymethyl)-5-(trifluoromethyl)-1 H -pyrrole-3-carbonitrile, in or on Basil, fresh leaves at 80 parts per million (ppm); Chive, fresh leaves at 20 ppm; Cucumber at 0.5 ppm; and Vegetable, fruiting, group 8-10 at 2.0 ppm. Upon establishment of the above tolerance, the petitioner requested removal of the existing tolerance on Vegetable, fruiting, group 8-10 at 1.0 ppm. That document referenced a summary of the petition prepared by BASF Corporation, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

Based upon review of the data supporting the petition and pursuant to its authority in section 408(d)(4)(A)(i), EPA is establishing the requested tolerances and one tolerance at a different level than requested. The reason for this change is explained in Unit IV.C.

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

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

Chlorfenapyr has moderate acute toxicity via the oral route of exposure and low acute toxicity via the dermal and inhalation routes of exposure. It is a mild eye irritant, but it is not a dermal irritant or sensitizer. Chlorfenapyr targets the central nervous system (CNS), inducing neurohistological changes (spongiform myelinopathy of the brain and spinal cord and vacuolization of the brain, spinal cord, and optic nerve) from subchronic and chronic dietary administration in mice and rats. In addition to neuropathology, rats also exhibited neurobehavioral changes on the day of dosing in the acute neurotoxicity study. Decreased motor activity was observed in the acute neurotoxicity study as well as in offspring in the developmental neurotoxicity (DNT) study. Several rat studies also noted effects in the liver (increased organ weights and tumors) at similar doses or above those where CNS effects were seen. The liver was identified in metabolism studies as the single organ to have the highest recovery of administered dose.

There was evidence of increased quantitative susceptibility to offspring in the database as a result of chlorfenapyr exposure. In the 2-generation reproduction study, decreased pup weights were seen at a lower dose than parental toxicity (decreased body-weight). In the DNT study, offspring toxicity (decreased motor activity and increased pup deaths on postnatal days 1-4) was seen in the absence of maternal toxicity. Additional effects on the CNS (vacuolation of white matter in the brain and decreased hippocampus size) were also observed in offspring at a higher dose in this study. There was no evidence of increased susceptibility to offspring in the developmental toxicity studies. In both the rat and rabbit developmental toxicity studies, although no maternal or developmental effects were noted up to the highest doses tested (HDT), maternal observations are limited in these developmental studies. Consequently, the data from the DNT are considered more robust for assessing the effects of chlorfenapyr on the nervous system.

Chlorfenapyr has a relatively high octanol-water partition coefficient and due to its lipophilic nature has been shown to accumulate in milk in a dietary cow study. Additionally, in the rat metabolism study, chlorfenapyr was found to accumulate in the fat tissue, such that females exhibited greater accumulation than males. This observation suggests chlorfenapyr is capable of accumulating in breast milk and leading to the early pup deaths seen in the reproduction toxicity and DNT studies through lactation.

Furthermore, the lack of toxicity in the rat and rabbit developmental studies suggests that the early pup deaths in the reproduction toxicity and DNT studies is the result of postnatal exposure through lactation.

EPA has concluded that a nonlinear approach using the chronic RfD for assessing cancer risk is appropriate for chlorfenapyr. For more information about this conclusion, see section 4.5.3 in the document entitled “SUBJECT: Chlorfenapyr. Human Health Risk Assessment for the Proposed New Uses on Greenhouse-Grown Basil, Chive, Cucumber, and Small Tomatoes,” in docket ID number EPA-HQ-OPP-2018-0783.

Specific information on the studies received and the nature of the adverse effects caused by chlorfenapyr 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 entitled “SUBJECT: Chlorfenapyr. Human Health Risk Assessment for the Proposed New Uses on Greenhouse-Grown Basil, Chive, Cucumber, and Small Tomatoes,” at pages 24-28 in docket ID number EPA-HQ-OPP-2018-0783.

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 chlorfenapyr used for human risk assessment is discussed in Unit III of the final rule published in the Federal Register of January 26, 2018 (83 FR 3605) (FRL-9970-88).

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to chlorfenapyr, EPA considered exposure under the petitioned-for tolerances as well as all existing chlorfenapyr tolerances in 40 CFR 180.513. EPA assessed dietary exposures from chlorfenapyr 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 chlorfenapyr. In estimating acute dietary exposure, EPA used the Dietary Exposure Evaluation Model—Food Consumption Intake Database (DEEM-FCID), Version 3.16, which uses food consumption data from the U.S. Department of Agriculture's National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA) from 2003-2008. As to residue levels in food, EPA's acute unrefined analysis used tolerance-level residues and 100% crop-treated (PCT). DEEM processing factors were set to 1 for all commodities except tomato and peppers. EPA 2018 default processing factors were used in the acute dietary analyses for tomato and pepper processed raw agricultural commodities (RACs) to account for potential imports of foreign agricultural use of chlorfenapyr.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment, EPA used the DEEM-FCID, Version 3.16, which uses food consumption data from the U.S. Department of Agriculture's National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA) from 2003-2008. As to residue levels in food, EPA's chronic analysis was unrefined and used tolerance-level residues and 100 PCT. DEEM processing factors were set to 1 for all commodities except tomato and peppers. EPA 2018 default processing factors were used in the chronic dietary analyses for tomato and pepper processed RACs to account for potential imports of foreign agricultural use of chlorfenapyr.

iii. Cancer. As indicated in Unit III.A., EPA has concluded that a nonlinear approach using the chronic RfD for assessing cancer risk is appropriate for chlorfenapyr; therefore, a separate quantitative cancer risk assessment is not required.

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

2. Dietary exposure from drinking water. Contamination of drinking water from chlorfenapyr is not expected to occur since none of the registered uses (which are all indoor uses) would result in residues in drinking water. Therefore, a dietary exposure assessment for chlorfenapyr in drinking water is unnecessary.

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).

Chlorfenapyr is currently registered for the following uses that could result in residential exposures: Crack/crevice/spot treatment on indoor and outdoor residential sites (including as a bed bug treatment). There are no residential uses associated with the petitioned-for new uses; therefore, an updated residential exposure assessment was not necessary for the proposed uses. The most conservative residential exposure scenarios were selected for use in the aggregate risk assessment. EPA combined post-application dermal and inhalation exposure from indoor applications (surfaces and mattresses) to control bed bugs to assess risks to adults and post-application dermal, inhalation, and hand-to-mouth exposures from indoor applications (surfaces and mattresses) to control bed bugs to assess risks to children 1 to <2 years old. The residential exposures are short- and intermediate-term for incidental oral, dermal and inhalation. No long-term exposures is 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 chlorfenapyr to share a common mechanism of toxicity with any other substances, and chlorfenapyr does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that chlorfenapyr 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. Although DNT studies show evidence of neurotoxicity/neuropathology and reproduction studies show susceptibility/sensitivity to offspring, the effects are well-characterized with clearly established NOAEL/LOAEL values and selected endpoints are protective for the observed effects.

3. Conclusion. EPA determined that the FQPA SF should be reduced to 1X for all exposure scenarios. That decision is based on the following findings:

i. The toxicity database for chlorfenapyr is complete.

ii. Although the central nervous system is the primary target for chlorfenapyr and neurotoxic effects were observed across studies, concern is low since the selected PODs are protective of observed neurotoxic effects.

iii. Although there is evidence of increased quantitative susceptibility in available DNT and reproduction studies, concern is low since the offspring effects are well-characterized with clearly established NOAEL/LOAEL values and the endpoints selected for risk assessment are protective of observed offspring effects.

iv. There are no residual uncertainties identified in the exposure databases. The dietary analysis assumed tolerance-level residues, EPA's 2018 default processing factors (except for tomatoes and peppers), and 100 PCT. The dietary analysis did not include exposure from drinking water as contamination of drinking water with chlorfenapyr as the result of all registered uses, including greenhouses or food/feed handling uses, is not expected to occur. EPA used similarly conservative assumptions to assess post-application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by chlorfenapyr.

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 chlorfenapyr will occupy 75% of the aPAD (at the 95th percentile of exposure) for children 3 to 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 chlorfenapyr from food and water will utilize 19% of the cPAD for children 3 to 5 years old, the population group receiving the greatest exposure. There are no chronic drinking water or residential exposure scenarios, therefore, the chronic aggregate risk is equivalent to the chronic dietary risk which is below the Agency's LOC.

3. Short- and intermediate-term risks. Short- and intermediate-term aggregate risk assessments were conducted since there is potential for short- and intermediate-term post-application exposures from previously registered uses of chlorfenapyr in residential settings. Short-term residential exposure estimates were aggregated with the average dietary exposure to provide a worst-case estimate of short-term aggregate risk for adults and children 1 to 2 years old (considered protective for children of all ages). Short-term aggregate MOEs are protective of intermediate-term exposure durations since the same endpoints and PODs were selected for both durations. Resulting short-term aggregate MOEs for adults at 660 and 120 for children (1 to 2 years old) are not of concern.

4. Aggregate cancer risk for U.S. population. As discussed in Unit III, the Agency has determined that quantification of risk using a non-linear approach ( i.e., using a cRfD) adequately accounts for all chronic toxicity, including carcinogenicity that could result from exposure to chlorfenapyr. Since there are no chronic risks of concern, the Agency concludes that aggregate exposure to chlorfenapyr will not pose a cancer risk.

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

The plant analytical enforcement method is designated as M2427, a gas chromatography/electron-capture detection (GC/ECD) method with a limit of quantitation (LOQ) of 0.05 ppm. The method has been subjected to a successful independent laboratory validation (ILV) as well as an acceptable radio validation using samples obtained from lettuce and tomato metabolism studies. EPA has concluded that method M2427 is adequate for data collection and tolerance enforcement purposes.

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: residuemethods@epa.gov.

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

There are no Codex maximum residue limits (MRLs) for residues of chlorfenapyr in/on the proposed commodities.

EPA revised the proposed tolerances for residues of chlorfenapyr on vegetable, fruiting, group 8-10 based on current OECD rounding classes. There is no need to remove the existing tolerance for vegetable, fruiting, group 8-10 at 1.0 ppm; rather EPA is simply amending the existing tolerance as requested.

Therefore, tolerances are established for residues of the insecticide chlorfenapyr, 4-bromo-2-(4-chlorophenyl)-1-(ethoxymethyl)-5-(trifluoromethyl)-1 H -pyrrole-3-carbonitrile, in or on Basil, fresh leaves at 80 ppm; Chive, fresh leaves at 20 ppm; and Cucumber at 0.5 ppm; and Vegetable, fruiting, group 8-10 at 2 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 tolerances in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ), do not apply.

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

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

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

Therefore, 40 CFR chapter I is amended as follows:

On August 8, 2018, in accordance with 40 CFR 281.51(a), Georgia submitted a complete program revision application (State Application) seeking approval of changes to its UST program. EPA now makes a final decision that Georgia's UST program revisions are no less stringent than the corresponding Federal program. Therefore, the EPA grants Georgia final approval to operate its UST program with the changes described in the State Application and as outlined in the proposed rule published in the September 16, 2019 Federal Register at 84 FR 48573. Although no comments were received on the EPA's proposed approval of Georgia's UST program revisions, the EPA noticed an error in the date of the Georgia statutory and regulatory materials listed in the proposed regulatory text at 40 CFR 282.60(d)(1)(i). The date of these materials was improperly listed as August 2018. The EPA has corrected the date in the final regulatory text to August 2019. The State's federally-approved and codified UST program as revised pursuant to this action will remain subject to the EPA's inspection and enforcement authorities under sections 9005 and 9006 of RCRA subtitle I and other applicable statutory and regulatory provisions.

Codification is the process of placing citations and references to a state's statutes and regulations that comprise a state's approved UST program into the Code of Federal Regulations (CFR). The EPA codifies its approval of state programs in 40 CFR part 282 and incorporates by reference state statutes and regulations that the EPA can enforce, after the approval is final, under sections 9005 and 9006 of RCRA, and any other applicable statutory provisions. The incorporation by reference of EPA-approved state programs in the CFR should substantially enhance the public's ability to discern the status of the approved state UST program and state requirements that can be federally enforced. This effort provides clear notice to the public of the scope of the approved program in each state.

In 1996, the EPA incorporated by reference and codified Georgia's approved UST program at 40 CFR 282.60 (61 FR 4224, February 5, 1996). Through this action, the EPA is amending 40 CFR 282.60 to incorporate by reference and codify Georgia's revised UST program.

In this rule, the EPA is finalizing regulatory text that incorporates by reference the federally approved Georgia UST program, including the revisions described in the State Application. In accordance with the requirements of 1 CFR 51.5, the EPA is incorporating by reference Georgia's statutes and regulations as described in the amendments to 40 CFR part 282 set forth below. These documents are available through https://www.regulations.gov and at the EPA Region 4 office (see the FOR FURTHER INFORMATION CONTACT section of this preamble for more information).

Specifically, in Section 282.60(d)(1)(i), the EPA is incorporating by reference the Georgia-approved UST program. Section 282.60(d)(1)(ii) identifies the State's statutes and regulations that are part of the approved State program, although not incorporated by reference for enforcement purposes. Section 282.60(d)(2) through (d)(5) reference the Attorney General's Statement, Demonstration of Adequate Enforcement Procedures, the Program Description, and the Memorandum of Agreement, which are part of the State Application and approved as part of the UST program under subtitle I of RCRA.

The EPA retains the authority under sections 9003(h), 9005, and 9006 of subtitle I of RCRA, 42 U.S.C. 6991b(h), 6991d, and 6991e, and other applicable statutory and regulatory provisions, to undertake corrective action, inspections, and enforcement actions, and to issue orders in approved states. If the EPA determines it will take such actions in Georgia, the EPA will rely on federal sanctions, federal inspection authorities, and other federal procedures rather than the State analogs. Therefore, the EPA is not incorporating by reference Georgia's procedural and enforcement authorities, although they are listed in 40 CFR 282.60(d)(1)(ii).

Some provisions of the State's UST program are not part of the federally approved State program because they are “broader in scope” than the federal UST program. 40 CFR 281.12(a)(3)(ii) states that, where an approved state program has provisions that are broader in scope than the federal program, those provisions are not a part of the federally approved program. As a result, State provisions which are “broader in scope” than the federal program are not incorporated by reference for purposes of enforcement in part 282. In addition, provisions that are external to the State UST program approval requirements, but included in the State Application, are also being excluded from incorporation by reference in part 282. For reference and clarity, 40 CFR 282.60(d)(1)(iii) lists the Georgia statutory and regulatory provisions which are “broader in scope” than the federal program and external to state UST program approval requirements. These provisions are, therefore, not part of the approved program that the EPA is codifying. Although these provisions cannot be enforced by the EPA, the State will continue to implement and enforce such provisions under State law.

This final action merely approves and codifies Georgia's revised UST program requirements pursuant to RCRA section 9004 and does not impose additional requirements other than those imposed by State law. For further information on how this action complies with applicable executive orders and statutory provisions, please see the proposed rule published in the September 16, 2019 Federal Register at 84 FR 48573. The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this document and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2). This final action will be effective February 14, 2020.

For the reasons set forth in the preamble, EPA is amending 40 CFR part 282 as follows:

I. Background

In FR Doc. 2019-24138 of November 12, 2019 (84 FR 61142), “Medicare Program: Changes to Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Revisions of Organ Procurement Organizations Conditions of Coverage; Prior Authorization Process and Requirements for Certain Covered Outpatient Department Services; Potential Changes to the Laboratory Date of Service Policy; Changes to Grandfathered Children's Hospitals-Within-Hospitals; Notice of Closure of Two Teaching Hospitals and Opportunity to Apply for Available Slots” (hereinafter referred to as the CY 2020 OPPS/ASC final rule with comment period), there was a technical error in the regulations text that is identified and corrected in this correcting amendment. The provisions of this correcting amendment are treated as if the technical error in the regulations text at § 410.27 that resulted from the error in the document published November 12, 2019 had not occurred. Accordingly, the corrections are applicable beginning January 1, 2020.

On page 61490 of the CY 2020 OPPS/ASC final rule with comment period, we made a technical error in an amendatory instruction which resulted in the unintended removal of paragraphs (a)(1)(iv)(C), (D), and (E) from § 410.27 of the CFR. Accordingly, we are amending § 410.27 to accurately reflect the intent as described in the preamble language included in the CY 2020 OPPS/ASC final rule with comment period (84 FR 61359 through 61363), but which was not properly reflected in the regulatory text portion of the rule. In the amendatory instruction, we stated that “§ 410.27 is amended by revising paragraph (a)(1)(iv).” The amendatory instruction should have read “§ 410.27 is amended by revising paragraphs (a)(1)(iv) introductory text, (a)(1)(iv)(A), and (B). This error in the amendatory instruction resulted in § 410.27(a)(1)(iv)(C) through (E) being erroneously removed. Therefore, this correcting amendment corrects this error by adding paragraphs (a)(1)(iv)(C), (D), and (E).

Under 5 U.S.C. 553(b) of the Administrative Procedure Act (APA), the agency is required to publish a notice of the proposed rule in the Federal Register before the provisions of a rule take effect. Similarly, section 1871(b)(1) of the Act requires the Secretary to provide for notice of the proposed rule in the Federal Register and provide a period of not less than 60 days for public comment. In addition, section 553(d) of the APA, and section 1871(e)(1)(B)(i) mandate a 30-day delay in effective date after issuance or publication of a rule. Sections 553(b)(B) and 553(d)(3) of the APA provide for exceptions from the notice and comment and delay in effective date APA requirements; in cases in which these exceptions apply, sections 1871(b)(2)(C) and 1871(e)(1)(B)(ii) of the Act provide exceptions from the notice and 60-day comment period and delay in effective date requirements of the Act as well. Section 553(b)(B) of the APA and section 1871(b)(2)(C) of the Act authorize an agency to dispense with normal rulemaking requirements for good cause if the agency makes a finding that the notice and comment process are impracticable, unnecessary, or contrary to the public interest. In addition, both section 553(d)(3) of the APA and section 1871(e)(1)(B)(ii) of the Act allow the agency to avoid the 30-day delay in effective date where such delay is contrary to the public interest and an agency includes a statement of support.

We believe that this correcting amendment does not constitute a rulemaking that would be subject to these requirements. This correcting amendment corrects a technical error in the regulations text included in the CY 2020 OPPS/ASC final rule with comment period but does not make substantive changes to the policies that were adopted in the final rule with comment period. As a result, the corrections made through this correcting amendment are intended to ensure that the information in the CY 2020 OPPS/ASC final rule with comment period accurately reflects the policies adopted.

In addition, even if this were a rulemaking to which the notice and comment procedures and delayed effective date requirements applied, we find that there is good cause to waive such requirements. Undertaking further notice and comment procedures to incorporate the corrections in this document into the final rule with comment period or delaying the effective date would be contrary to the public interest because it is in the public's interest to ensure that the CY 2020 OPPS/ASC final rule with comment period accurately reflects our policies as of the date they take effect and are applicable.

Furthermore, such procedures would be unnecessary, as we are not altering our policies, but rather, we are simply correctly implementing the policies that we previously proposed, received comment on, and subsequently finalized. This correcting amendment is intended solely to ensure that the CY 2020 OPPS/ASC final rule with comment period accurately reflects these policies. For these reasons, we believe we have good cause to waive the notice and comment and effective date requirements.

Accordingly, 42 CFR chapter IV is corrected by making the following correcting amendment:

NMFS published the proposed rule in the Federal Register on October 24, 2019 (84 FR 56998) with public comments invited through November 25, 2019.

The North Pacific Fishery Management Council (Council) recommended this final rule, which clarifies the administration of the IFQ Program medical transfer and beneficiary transfer provisions. These changes benefit IFQ Program participants, their beneficiaries, and NMFS by providing clear standards, reducing potential inconsistencies with other definitions used for other state or Federal programs, and reducing administrative costs and burdens associated with existing regulatory provisions.

The following background sections describe (1) the IFQ Program, (2) the IFQ medical transfer provision, (3) the IFQ beneficiary transfer provision, and (4) the appeals process. Additional detail is provided in the preamble to the proposed rule (84 FR 56998, October 24, 2019).

The commercial halibut and sablefish fisheries in the GOA and the BSAI management areas are managed under the IFQ Program that was implemented in 1995 (58 FR 59375, November 9, 1993). The Council and NMFS developed the IFQ Program to resolve the conservation and management problems commonly associated with open access fisheries. The preamble to the proposed rule published on December 3, 1992 (57 FR 57130), describes the background issues leading to the Council's initial action recommending the adoption of the IFQ Program. Section 2.2 of the Analysis and the preamble of the proposed rule (see ADDRESSES ) provide additional information on the sablefish and halibut IFQ Program.

The Council and NMFS created the provisions of the IFQ Program to support the conservation and management objectives of the Magnuson-Stevens Act and the Halibut Act while retaining the “owner-operator” character of the fishing fleets as much as possible.

The IFQ Program includes a medical transfer provision that allows quota share (QS) holders of catcher vessel QS (referred to as class B, C, and D QS shares) who are not otherwise eligible to use a hired master to temporarily transfer (lease) their annual IFQ to another individual if the QS holder or an immediate family member has a temporary medical condition that precludes the QS holder from fishing (72 FR 44795, August 9, 2007). This provision allows QS holders with a temporary medical condition, or caring for an immediate family member with a medical condition, that would preclude the QS holder from fishing during a season, to transfer their annual IFQ to another qualified individual. In recommending this medical transfer provision, the Council and NMFS balanced the objective to limit long-term leasing of QS to promote an owner-onboard fishery with its recognition that a medical transfer provision would provide a mechanism for QS holders to retain their QS during bona fide medical hardships.

Prior to implementation of this provision in 2007, a QS holder with a medical condition was required to divest his or her QS or allow the IFQ to go unfished during years he or she could not be on board the vessel. Medical transfers were not intended to be a mechanism for persons unable or unwilling to participate in the fishery as an owner onboard to continue to receive economic benefits from their QS holdings, but were intended to address legitimate medical conditions that precluded participation (72 FR 44795, August 9, 2007).

To limit potential for repeated, long-term, or illegitimate use of the medical transfer provision, the current provisions: (1) Apply only to individuals who are not otherwise eligible to use hired masters; (2) apply only to IFQ derived from catcher vessel QS held by the applicant; (3) require certification by specific types of medical providers who must describe the condition (and the care required if caring for an immediate family member); (4) require verification of the inability of the QS holder to participate in IFQ fisheries; and (5) contain a use cap of two years in a five-year period.

In 1996, NMFS amended the IFQ Program regulations to allow for a temporary transfer of QS to surviving spouses of deceased QS holders (61 FR 41523, August 9, 1996). In 2000, a final rule (65 FR 78126, December 14, 2000) expanded the existing survivorship transfer provisions in 50 CFR 679.41(k) to include an immediate family member designated as a beneficiary to whom the survivorship transfer privileges would extend in the absence of a surviving spouse. This transfer is intended to benefit the surviving spouse, or an immediate family member designated by the QS holder, for a limited period of time.

To transfer QS under this beneficiary provision, the surviving spouse, or the designated beneficiary named on the QS/IFQ Beneficiary Designation Form by the QS holder, submits an Application for Transfer of QS/IFQ. These forms are processed by NMFS Restricted Access Management (RAM) Program.

NMFS may approve an application to transfer QS to the surviving spouse or designated beneficiary, unless a contrary intent is expressed by the decedent in a will and if sufficient evidence has been provided to verify the death of the individual. Legally, for purposes of transferring QS, a beneficiary identified in a will overrides any beneficiary designated on the form submitted to NMFS. NMFS allows the transfer of IFQ resulting from the QS transferred to the beneficiary by right of survivorship for a period of three years following the death of the QS holder. After the three-year period expires, the spouse or designated beneficiary must qualify to either hold the QS through eligibility criteria found at 50 CFR 679.41(d) or transfer the QS. Currently, the program allows the QS holder to designate a beneficiary that can either be the surviving spouse, or in the absence of a surviving spouse, an immediate family member.

Section 2.5.1 of the Analysis states that NMFS has received beneficiary transfer applications from persons who do not meet a commonly used definition of an immediate family member, which currently includes a person's parents, spouse, siblings, and children. This traditional definition for making determinations regarding transfer eligibility under the designated beneficiary transfer provision is narrower than many State and Federal beneficiary definitions currently applied in a variety of government programs. Since the current surviving regulations were implemented, the definition of immediate family has changed in many State and Federal jurisdictions and now includes other persons connected to a QS holder by birth, adoption, marriage, civil partnership, or cohabitation. NMFS and IFQ Program participants would benefit from clarifying this provision's applicability to those family members.

If NMFS denies a transfer under the existing medical and beneficiary transfer provisions, a QS holder may appeal this denial through the National Appeals Office (NAO). If a claim is submitted that is inconsistent with the information required in regulations or if the transfer requested is beyond the number of years allowed, the QS holder would have the burden of proving that the submitted claim is correct. NMFS would not accept claims that are inconsistent with the official record, unless they are supported by clear, written documentation.

Prior to 2014, the procedure for appealing an initial administrative determination (IAD) was to submit the appeal directly to the NMFS's Alaska Office of Administrative Appeals. That process was described at § 679.43. However in 2014, NMFS centralized the appeals process to be located in the NAO, which operates out of NMFS's headquarters in Silver Spring, Maryland. That process is described at 15 CFR part 906 (79 FR 7056, February 6, 2014). The appeals process described at § 679.43 is no longer applicable given the regulatory changes made in 2014.

This section describes this rule, its effects on fishery participants and the environment, and the changes to current regulations at 50 CFR part 679. The Council recommended and NMFS approves the following changes to the medical and beneficiary transfer provisions of the IFQ Program.

This final rule makes several changes to the medical transfer provision that include changes to: (1) Remove the definitions at § 679.2 for “Advanced nurse practitioner,” “Licensed medical doctor,” and “Primary community health aide;” and add a definition at § 679.2 for “Health care provider,” and (2) modify § 679.42(d)(2) to allow medical transfers for any medical condition and to allow the transfers to be used for three of the seven most recent years.

The first change removes definitions of specific types of medical professionals and includes a definition of a “Health care provider” at § 679.2. This change broadens the definition of who may attest to a medical condition of the QS holder, or his or her immediate family member, that precludes a QS holder from participating in the IFQ fisheries. This increases flexibility for a QS holder when selecting a health care provider for treatment and verifying the condition on the medical transfer application. Defining a certified medical professional is important because it sets the boundaries for who is allowed to attest that a QS holder is not physically able to fish his or her IFQ. This final rule broadens the current definition while limiting the persons to those who are licensed or certified by the state or country in which they practice. This final rule also allows health care providers outside the United States to sign the medical transfer form. NMFS expects that any expansion of the definition over the status quo would be beneficial to QS holders, or their immediate family member, who need medical care and would lead to less rejections of applications based solely on the specialty of the health care provider.

The second change to § 679.42(d)(2) applies to the medical transfer limits. This final rule extends the number of years a medical transfer could be used from two of the five most recent years to three of the seven most recent years, which increases flexibility for those who need it. A year is defined as a calendar year, which is how IFQ permits are currently issued. NMFS will begin to measure a seven-year period during the first calendar year that a medical transfer of IFQ is approved. After the third year a medical transfer is approved under the medical transfer provision, QS holders will not be able to transfer their IFQ for any medical condition for the remainder of the seven-year period that began the first calendar year the medical transfer of IFQ was approved. Section 2.4.4 of the Analysis and the preamble of the proposed rule provide additional detail on the range of years during which a medical transfer could apply and additional rationale for the provisions selected in this final rule.

This final rule also makes several minor revisions to § 679.42(d)(2) to implement these changes to the medical transfer provisions. This final rule removes the current regulatory requirements at § 679.42(d)(2)(iii)(F) that require that the application describe the medical condition affecting the applicant or applicant's immediate family member. This change reduces the requirement that medical information would need to be reviewed by NMFS staff. This final rule removes requirements at § 679.42(d)(2)(iii) that an applicant provide his or her social security number because such information is no longer required to process transfer applications. This final rule replaces references to “advanced nurse practitioner,” “licensed medical doctor,” and “primary community health aide” with “health care provider” at § 679.42.

These revisions apply only to medical transfers that are approved after the effective date of these regulations.

This final rule makes two changes to the beneficiary transfer provision to: (1) Define “immediate family member” at § 679.2; and (2) modify § 679.41 to add estate representative to the list of people who can receive IFQ held by the decedent for up to three years. These changes improve and simplify the process of approving beneficiary transfers without causing undue negative impacts on a QS holder's estate planning.

This final rule defines “immediate family member” in § 679.2 using a current definition established by the U.S. Office of Personnel Management (OPM) that is broader, providing greater flexibility to QS holders and their beneficiaries. The OPM definition is commonly used in Federal programs that provide benefits to immediate family members and includes persons connected to the QS holder by birth, adoption, marriage, civil partnership, or cohabitation, such as grandparents, great-grandparents, grandchildren, great-grandchildren, aunts, uncles, siblings-in-law, half-siblings, cousins, adopted children, step-parents/step-children, and cohabiting partners. Section 2.5.4 of the Analysis describes the range of definitions considered by the Council and NMFS and additional information on the rationale for the specific definition described in this rule.

This final rule modifies all references in § 679.41 to surviving spouse and immediate family member in regulation by adding the term “estate.” Without this change, the QS holder's estate would not be eligible to hold QS under the beneficiary transfer provision.

This final rule clarifies that an estate could receive QS, and the court-appointed estate representative for the QS holder's estate are authorized to use (if they are eligible to hold QS) or transfer the IFQ derived from the estate's QS for the benefit of the estate for a period of three years following the QS holder's death. NMFS will allow the estate representative to manage the use of the decedent's QS holdings by allowing the representative to transfer IFQ annually on behalf of the estate. If after three years the estate is not settled, the estate representative could determine whether the QS held by the estate should be sold and the proceeds retained by the estate, or the estate should continue to hold the QS. However, the estate would no longer be eligible to use the beneficiary transfer provisions to lease the annual IFQ. An estate representative is required to submit court-issued documents to demonstrate his or her eligibility to NMFS that they are legally representing the estate before they could use, permanently transfer, or temporarily transfer (lease) the IFQ. This addition provides clear and consistent eligibility criteria for NMFS to determine if a person is eligible to transfer QS held by the estate of the deceased QS holder as well as use or lease the IFQ derived from those QS holdings. For more information on the beneficiary transfer provisions, please see the preamble of the proposed rule.

In addition to modifications to the medical and beneficiary transfer provisions and the revisions to the appeals process regulations, this final rule makes two minor regulatory clarifications. First, this final rule modifies regulations at § 679.42 to update the NOAA website URL and make minor technical corrections to remove unnecessary information collected such as Social Security numbers, number of IFQ units, and notary requirements. Second, this final rule modifies regulations at § 679.42(d)(2)(iii)(D) to add an additional way to describe “other method of compensation” to provide flexibility to industry who may use a percentage of the total revenue as compensation instead of price per pound when they conduct transfers under this provision.

NMFS received one comment letter and has summarized and responded to the comment below.

Comment 1: I do not support fishermen receiving any medical benefits. They are depleting fish stocks and destroying the marine ecosystem.

Response: This comment raises management issues that are beyond the scope of this regulatory action. This final rule does not modify the annual process for establishing annual catch limits, or other regulations that limit harvest to prevent overfishing. This final rule does not modify regulations that limit the amount or type of gear, or the location of fisheries in ways that would adversely affect marine ecosystems.

The IFQ Program does not provide medical benefits, such as health insurance, to participants. This provision was intended to provide a mechanism for QS holders with a temporary medical condition, or caring for an immediate family member with a medical condition, that would preclude the QS holder from fishing during a season to transfer their annual IFQ to another qualified individual. In recommending this medical transfer provision, the Council and NMFS balanced the objective to limit long-term leasing of QS to promote an owner-onboard fishery with its recognition that a medical transfer provision would provide a mechanism for QS holders to retain their QS during medical hardships.

There were no changes from the proposed to final rule.

The NMFS Alaska Region Administrator determined that this final rule is necessary for the conservation and management of the IFQ sablefish and halibut fishery off Alaska and that it is consistent with the Magnuson-Stevens Fishery Conservation and Management Act, the Halibut Act, and other applicable laws.

Regulations governing the U.S. fisheries for Pacific halibut are developed by the IPHC, the Pacific Fishery Management Council, the Council, and the Secretary. Section 5(c) of the Halibut Act allows the Regional Council having authority for a particular geographical area to develop regulations governing the allocation and catch of halibut in U.S. Convention waters as long as those regulations do not conflict with IPHC regulations (16 U.S.C. 773c(c)). This final rule is consistent with the Council's authority to allocate halibut catches among fishery participants in the waters in and off Alaska. The Halibut Act provides the Secretary with the general responsibility to carry out the Convention with the authority to, in consultation with the Secretary of the department in which the U.S. Coast Guard is operating, adopt such regulations as may be necessary to carry out the purposes and objectives of the Convention and the Halibut Act (16 U.S.C. 773c(a) and (b)). This final rule is consistent with the Halibut Act and other applicable laws.

This final rule has been determined to be not significant for the purposes of Executive Order 12866.

This final rule is considered an Executive Order 13771 deregulatory action. NMFS estimates that this rulemaking may result in cost savings to the industry and NMFS through an increase in flexibility and streamlined reporting requirements for participants who voluntarily chose to use these provisions. However, these cost savings cannot be quantified because NMFS does not know how many participants would benefit from the revised transfer provisions included in this rule and cannot associate a dollar amount with these benefits. This rule streamlines the NMFS administrative process to review and approve IFQ transfer applications. Any annual cost savings are expected to be small, however, because the time it will take to process each application is still expected to vary but will be overall less complicated.

Section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996 states that, for each rule or group of related rules for which an agency is required to prepare a final regulatory flexibility analysis, the agency shall publish one or more guides to assist small entities in complying with the rule, and shall designate such publications as “small entity compliance guides.” The agency shall explain the actions a small entity is required to take to comply with a rule or group of rules. As part of this rulemaking process, NMFS included on its website a summary of compliance requirements that serves as the small entity compliance guide. Additionally, NMFS will engage in outreach with regulated entities regarding the compliance requirements. Copies of this final rule are available from NMFS at the following website: https://www.fisheries.noaa.gov/region/alaska.

This final regulatory flexibility analysis (FRFA) incorporates the Initial Regulatory Flexibility Analysis (IRFA), a summary of any significant issues raised by the public comments in response to the IRFA, NMFS's responses to those comments, and a summary of the analyses completed to support the final rule.

Section 604 of the Regulatory Flexibility Act (RFA) requires that, when an agency promulgates a final rule under section 553 of Title 5 of the U.S. Code (5 U.S.C. 553), after being required by that section or any other law to publish a general notice of proposed rulemaking, the agency shall prepare a FRFA (5 U.S.C. 604). Section 604 describes the required contents of a FRFA: (1) A statement of the need for and objectives of the rule; (2) a statement of the significant issues raised by the public comments in response to the IRFA, a statement of the assessment of the agency of such issues, and a statement of any changes made to the proposed rule as a result of such comments; (3) the response of the agency to any comments filed by the Chief Counsel for Advocacy of the Small Business Administration (SBA) in response to the proposed rule, and a detailed statement of any change made to the proposed rule in the final rule as a result of the comments; (4) a description of and an estimate of the number of small entities to which the rule will apply or an explanation of why no such estimate is available; (5) a description of the projected reporting, recordkeeping, and other compliance requirements of the rule, including an estimate of the classes of small entities that will be subject to the requirement and the type of professional skills necessary for preparation of the report or record; and (6) a description of the steps the agency has taken to minimize the significant economic impact on small entities consistent with the stated objectives of applicable statutes including a statement of the factual, policy, and legal reasons for selecting the alternative adopted in this final rule and why each one of the other significant alternatives to the rule considered by the agency which affect the impact on small entities was rejected.

A description of this final rule and the need for and objectives of this rule are contained in the preamble to this final rule and the preamble to the proposed rule (84 FR 56998, October 24, 2019), and are not repeated here.

An IRFA was prepared in the Classification section of the preamble to the proposed rule. The Chief Counsel for Advocacy of the SBA did not file any comments on the proposed rule. NMFS received no comments relating to the IRFA.

QS holders that fish catcher vessel QS (B, C, and D class QS) are assumed to be directly regulated by this action. Section 2.9 of the Analysis assumes that all halibut and sablefish QS operations are small for RFA purposes. In 2018, there were 2,418 QS holders that held class B, C, or D QS in the halibut and sablefish IFQ fisheries who could be impacted by this action. All of those QS holders are considered to be small entities using the SBA small entity criteria for harvest on catcher vessels.

This final rule modifies the recordkeeping, reporting, and other compliance requirements for QS holders who use the medical transfer provision and beneficiary designation form. NMFS does not anticipate that these requirements would increase.

This final rule would not require NMFS to interpret the medical condition that prevents a QS holder from harvesting their IFQ. Instead, NMFS would apply a hard limit to the number of times the provision can be used.

Currently, NMFS provides QS holders an optional Beneficiary Designation form to designate a beneficiary to transfer IFQ under this provision. NMFS may approve an application to transfer QS to the surviving spouse or designated beneficiary, unless a contrary intent is expressed by the decedent in a will and if sufficient evidence has been provided to verify the death of the individual.

Both the medical transfer provision and the beneficiary transfer provision are voluntary and are expected to be used by QS holders only if they or their beneficiaries find them beneficial. The Council and NMFS considered requirements that would have imposed larger costs on directly regulated small entities through increased administrative costs. Ultimately, the Council and NMFS rejected options that would have led to an increase in costs that exceeded the marginal potential benefits that the option could have had. Several options that were rejected would have increased the cost to program and monitor for minimal benefit to participants. Therefore, this final rule meets the objectives of the final rule while minimizing adverse impacts on IFQ Program participants.

This final rule contains collection-of-information requirements subject to review and approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act (PRA). NMFS has submitted these requirements to OMB for approval under Control Number 0648-0272.

The public reporting burden per response is estimated to average 1.5 hours for the Application for Medical Transfer of IFQ and 30 minutes for the QS/IFQ Beneficiary Designation Form. The response time includes the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.

Notwithstanding any other provision of the law, no person is required to respond to, nor shall any person be subject to penalty for failure to comply with, a collection of information subject to the requirement of the PRA, unless that collection of information displays a currently valid OMB control number. All currently approved NOAA collections of information may be viewed at: https://www.reginfo.gov/public/do/PRASearch#.

For the reasons set out in the preamble, 50 CFR part 679 is amended as follows: