Section 762 of the Consolidated Appropriations Act of 2021 (CAA) (Pub. L. 116-260) authorizes the Secretary of Agriculture (Secretary) to establish a program to reimburse dairy organizations for donated dairy products to non-profit organizations for distribution to recipient individuals and families. The Secretary delegated authority to establish and administer this program to the Agricultural Marketing Service (AMS). The program was implemented on September 1, 2021, through an interim final rule (86 FR 48887). This rule finalizes and makes minor changes to the provisions of the Dairy Donation Program (DDP) codified at 7 CFR part 1147. Program provisions are intended to encourage the donation of dairy products and to prevent and minimize food waste.

The DDP is an additional donation program that overlays existing United States Department of Agriculture (“USDA” or “Department”) dairy milk donation activities, such as the Milk Donation Reimbursement Program (MDRP). The MDRP was established as part of the 2018 Farm Bill to facilitate the donation of fluid milk products and avoid food waste. The program was funded with $9 million in fiscal year 2019, and $5 million per fiscal year thereafter. DDP and MDRP are separate from USDA purchase programs. These donation programs provide for reimbursement of certain costs for donations made between two private entities. Food purchases under USDA's The Emergency Food Assistance Program (TEFAP) and Section 32 programs are made through a bid process where USDA purchases the product and arranges for delivery to the distribution point.

DDP and MDRP are separate and distinct from USDA's Dairy Margin Coverage (which acts as a safety net program), indemnity and disaster assistance programs, risk management tools through the public-private partnership of the Federal Crop Insurance Program, or USDA purchases of commodities, which may include dairy products depending on the market conditions and demand from school lunch or nutrition programs.

This rule also makes corresponding minor changes to the MDRP provisions (codified at 7 CFR part 1146) previously amended by the interim final rule. In this rule, AMS is making minor changes to the DDP information collection forms, which also apply to MDRP, to gain administrative efficiencies and lessen the burden for entities participating in the two programs. The form changes include adding distribution center as an additional entity type and allowing for the Dairy Donation and Distribution Plan to include multiple partnerships per eligible dairy organization. These changes will be discussed in more detail later in the rule.

In 2020, the COVID-19 pandemic disrupted dairy supply chains and displaced significant volumes of milk normally used in food service channels. This led to milk being dumped or fed to animals across the United States. AMS estimates that the volume of milk dumped due to pandemic-related supply chain issues was almost triple what is typically observed during normal market conditions. 1 At the same time, amidst surging unemployment and economic hardship nationwide, an increasing number of individuals needed nutrient-dense foods such as dairy products. Throughout 2020 and 2021, milk and dairy products were included in food donations authorized under the Coronavirus Aid, Relief, and Economic Security Act (CARES) and through the Commodity Credit Corporation (CCC). In December 2020, Congress authorized an additional $400 million until expended to establish the DDP, designed to encourage the timely and efficient distribution of dairy products to families and individuals while reducing food waste.

While the DDP was intended to assist in balancing the supply chain during the pandemic recovery, it also provides the benefit of creating an incentive to donate dairy products during the normal spring flush of milk production. During normal marketing years (pre-pandemic), daily milk production in the spring averaged 6 to 7 percent more than in the lower production months of the fall. 2 USDA's Economic Research Service (ERS), using 2020 and 2021 food security data, estimates that 10.5 and 10.2 percent, respectively, of U.S. households were food insecure. 3 The United States remains in the midst of the recovery, and even while employment is returning to normal levels, there continues to be food insecurity. The persistent need for nutrient-dense foods such as dairy products can be met, in part, through donations encouraged by the DDP.

An interim final rule was published in the Federal Register on September 1, 2021 (86 FR 48887). Copies of the rule were made available through the internet by the Department and the Office of the Federal Register. The rule provided a 60-day comment period which ended November 1, 2021. Four comments were received, which are discussed in the applicable sections of this final rule. While all comments supported the program, some requested consideration of changes to specific program provisions.

The program was initially established through an interim final rule, with regulations set to expire on September 1, 2023, unless program provisions are finalized. Congress rescinded current program funding through the Financial Responsibility Act of 2023, 4 enacted on June 3, 2023. However, this final rule completes the DDP rulemaking by addressing relevant public comments, making minor administrative changes to reduce burden on the industry, and removing the program's sunset provision.

The following paragraphs give a general overview of how the DDP operates. Detailed explanations of program provisions can be found later in the Program Provisions section.

Program eligibility continues to be open to eligible dairy organizations (EDOs), defined as dairy farmers (either individually or as part of a cooperative) or dairy processors that meet the following conditions: (1) account to a Federal Milk Marketing Order (FMMO) marketwide pool; and (2) incur a qualified expense. Although the definition of EDO includes individual dairy farmers, most farmers might not meet the other specified provisions to qualify as EDOs. For example, most farmers would not incur qualified expenses since they do not have the infrastructure to process raw milk into donated eligible dairy products. Those individual dairy farmers who do meet the required provisions would qualify as EDOs under statutes and this rule for both the DDP and MDRP.

The DDP and MDRP refer to the same statutory EDO definition; interpretation of that definition contained in the interim final rule was adopted by both programs. This final rule amends that interpretation, as explained below, to lessen the burden on participants and gain administrative efficiencies.

The DDP authorizing statute  5 adopts the EDO definition contained in the statute establishing the MDRP. 6 When AMS implemented the MDRP, it interpreted the statutory language, “account to an FMMO marketwide pool,” to apply to entities regulated by, and therefore filing reports with, an FMMO. Participation in the MDRP was limited, partly due to the requirement to be regulated.

The COVID-19 pandemic and its impacts affected the entire United States. Supply chain disruptions described earlier were not limited to only those regulated by an FMMO. Consequently, Congress authorized the DDP through a broad relief package. In reviewing Congressional intent to encourage dairy product donation across the country, AMS determined the interpretation of “account to” as requiring regulation by an FMMO to be too narrow. Instead, a broader definition allowing for an EDO to “account to” an FMMO marketwide pool by filing a report with an FMMO office was deemed more appropriate. Consequently, the interim final rule revised the definition of “eligible dairy organization” for MDRP by removing the requirement that the EDO be regulated under an FMMO. It also adopted the same definition for the DDP.

In the interim final rule, USDA determined that the specific report that an EDO must submit to “account to” an FMMO marketwide pool was a monthly report that lists its fresh fluid products and/or bulk dairy commodity products purchased and how they were utilized to produce donated eligible dairy products. A comment from a Puerto Rican dairy processor explained that the industry, as well as consumers, suffered severe economic losses due to the pandemic, which were exacerbated in Puerto Rico due to its isolation from major US markets. The commenter suggested that the program provide more reporting flexibility in non-FMMO regions to make program impacts more equitable.

AMS agrees with this commenter. To receive a reimbursement for donations under the DDP, an EDO is required to submit a Reimbursement Claim Form. Requiring entities not regulated by an FMMO to submit a monthly report in addition to the Reimbursement Claim Form is overly burdensome for participants because both forms contain duplicative information.

The filing of the initial report serves to establish a relationship between the EDO and the FMMO office that will be auditing its DDP reimbursements. All other information needed to administer the program is submitted through the application and reimbursement process. There is no additional need to collect duplicative information through a monthly report filing with the FMMO office. Therefore, this final rule finds that accounting to an FMMO marketwide pool can be satisfied by an entity submitting a report once to any FMMO office. EDOs can contact their local FMMO office or access the DDP website to determine the applicable FMMO office where the report should be filed. The filing of this report for the purpose of participating in the DDP does not cause the EDO to become regulated by the FMMO. For the reasons so stated, USDA is amending the definition in this final rule as requested by the commenter.

The statute further specifies that an EDO must incur a qualified expense. Since only Class I fluid products are donated through the MDRP and most Class I processors are regulated by an FMMO, incurring a qualified expense in the MDRP was originally interpreted as paying minimum classified values into an FMMO pool because that is the requirement for processors regulated by an FMMO. The interim final rule found that an EDO no longer needed to be regulated under an FMMO and added a definition of “qualified expense” to MDRP regulations to specify that a qualified expense is not tied to the FMMO regulatory requirement of paying minimum classified values. The DDP adopted the same definition in the interim final rule. This final rule continues to find those provisions appropriate.

EDOs incur a qualified expense by either purchasing a fluid milk product (raw milk, skim milk, cream, or concentrated fluid milk products) for processing into an eligible dairy product or purchasing bulk dairy commodity product for further processing into an eligible dairy product.

Dairy processors often buy fluid milk products for processing into dairy products. Dairy processors also purchase bulk dairy commodity products for further processing into retail packages. For example, a processor buys 40-pound cheese blocks to further process and package into 8-ounce blocks or bags of shredded cheese typically preferred by consumers and eligible distributors alike. The DDP is intended to facilitate these types of product donations. Therefore, in addition to processors who buy fluid milk products for processing, the DDP allows secondary processors who purchase and further process bulk commodities for donation to qualify as an EDO. To be considered an EDO, a secondary processor also needs to account to an FMMO marketwide pool as described earlier.

Once these two above conditions—accounting to an FMMO and incurring a qualified expense—are met, EDOs participate in the program by forming partnerships with eligible distributors and then submitting a Dairy Donation and Distribution Plan (Plan) to AMS for approval. If an EDO or eligible distributor is looking for a partner, they may contact the DDP Office ( ddp@usda.gov ) for assistance.

Upon Plan approval, EDOs can submit a Reimbursement Claim Form (Claim Form) to receive reimbursement for donations. The DDP reimburses EDOs for some of the following: a. input costs: milk equivalent of either a fluid milk product or a bulk dairy commodity product used in the eligible dairy product; b. manufacturing costs; and c. transportation costs.

In the FMMO system, milk is priced based on its end use. FMMO classifications are generally: Class I—traditionally the highest-class price—for beverage fluid milk products such as whole, skim, nonfat, and flavored milks; Class II for soft products such as yogurt, ice cream, and packaged fluid cream; Class III for spreadable and hard cheeses; and Class IV for butter and dried milk products. Announced monthly, FMMO-minimum classified prices reflect surveyed end-product wholesale market prices. Under an FMMO, regulated processors are required to pay at least minimum classified values based on how they use their milk.

This final rule continues to find that for processors purchasing and processing fresh fluid milk products (raw milk, skim milk, cream, or concentrated fluid products), the DDP will reimburse for the FMMO-minimum classified value applicable on the date of production for fresh fluid milk products used to make donated eligible dairy products. FMMO prices are a good approximation of what the processor paid for the fresh fluid milk products because they represent observed market values paid for product at the time of purchase.

The DDP does not reimburse for powders and other dry dairy products used as an ingredient in eligible dairy products (for example, powder used to fortify cheeses or ice cream.) Reimbursement is not extended to these ingredients because the DDP is designed to encourage the use of excess fresh fluid milk for donation, rather than being dumped. Dry milk powders in retail packaging—such as 10-ounce containers of nonfat dry milk, which are made directly from fresh fluid milk—continue to be considered eligible dairy products under this program, as surplus milk is likely manufactured into dry milk powder as opposed to being dumped.

Since FMMO minimum classified prices are stated on a hundredweight basis, EDOs should continue to report donations in the quantity and size of the donated product, which is converted to hundredweights with a yield factor (how much product can be made from 100 pounds of milk). Applicable announced minimum class skim and butterfat prices are used in determining the input cost of the donated dairy product. EDOs have the ability to provide an actual product yield factor, or the EDO can use a standard yield factor. Standard yield factors are posted on the DDP website.

Secondary processors buying bulk dairy commodity products for further processing and donation, as described earlier, will continue to be reimbursed at the classified use value applicable for the month the eligible dairy product was processed into the consumer-type package. The reimbursed value represents the milk-equivalent market price of the bulk dairy product at the time of conversion into an eligible dairy product.

Processors incur expenses beyond input costs to make dairy products. To encourage dairy product donations, this final rule continues to reimburse for some of the manufacturing costs incurred to convert fluid milk products into eligible dairy products. These manufacturing costs are reimbursed at the manufacturing (make) allowance levels contained in the FMMO uniform pricing formulas, which are generally accepted by the industry as representative costs of manufacturing dairy products from raw milk.

The interim final rule found it appropriate for the Class IV make allowance contained in the Class IV price formula to apply to Class I and II products. USDA lacked data on Class I and II manufacturing costs and asked for public comment on this issue in the interim final rule. A comment submitted from a dairy trade association included average ranges for Class I and II manufacturing costs for its members that produced such products. Submitted information concluded Class I costs ranged from $4.50-$10 per hundredweight (cwt) and Class II costs ranged from $5-$6 per cwt. While the cost ranges provided a general approximation of those experienced by its members, the comment lacked details on the underlying data needed to determine what the average cost ranges represented. For example, the submission did not include the specific products represented, the data collection timeframe, types of costs incurred, geographic disbursement of plants, size of plants, or how much of the Class I or II markets were represented. No other comments on Class I and II manufacturing costs were received.

While the data provided lacked detail, it is reasonable to conclude the Class IV manufacturing allowance, which equates to $2.16 per cwt, is significantly lower than the actual cost experienced by Class I plants. This final rule continues to find that while the DDP should not reimburse for all manufacturing costs, it should strive to reimburse at a level adequate for processors to choose to process and donate dairy products instead of dumping milk.

During the first year of administering the DDP, USDA experienced fluid milk processors choosing not to participate because the reimbursement rate was too low. As the statutory objective of the program is to encourage the donation of milk and dairy products to individuals and families, this final rule finds that the manufacturing cost reimbursement for Class I products should be increased.

As the input cost reimbursed through the DDP aligns with the product's classification, this final rule finds manufacturing costs should be similarly aligned. Under FMMOs, the base raw skim milk value of Class I products is the average of the Class III and Class IV skim milk price formulas, plus $0.74. Implicitly, this means Class I handlers regulated by the FMMO system receive a Class I manufacturing allowance that is the average of the Class III and Class IV manufacturing allowances. Therefore, this final rule finds the manufacturing cost reimbursement for Class I products donated through the DDP should likewise be the average of the Class III and Class IV manufacturing allowances. Currently those manufacturing allowances equate to $3.17 per cwt and $2.16 per cwt, respectively, resulting in an average of $2.67 per cwt.

Recognizing Class II products are priced off the Class IV advanced skim milk pricing factor, Class II manufacturing costs reimbursed through the DPP will remain at the Class IV level, currently $2.16 per cwt.

This final rule makes no changes to the manufacturing cost reimbursement for Class III and IV products, which equates to $3.17 and $2.16 per hundredweight, respectively, for milk containing 3.5 percent butterfat. If the FMMO make allowances are updated in the future, DDP regulations referencing the FMMO regulations will be automatically adjusted.

The public comment submitted by the dairy trade association also suggested DDP manufacturing cost reimbursement be adjusted to more accurately reflect actual component tests of raw milk. The current FMMO make allowances, and therefore the DDP manufacturing reimbursement levels, reflect standard component levels—3.5% butterfat, 2.99% protein, and 5.69% other solids. According to the commenter, actual component tests of raw milk are higher (4% butterfat, for example). The comment states that incorporating these higher component levels would increase the manufacturing reimbursement under the DDP. This final rule finds the factors contained in the manufacturing allowances used in both the FMMO program and the DDP should be consistent. If FMMO make allowances are amended, this final rule allows for DDP manufacturing cost reimbursements to change automatically.

Transportation costs from the processor to a distribution outlet are often cost prohibitive. Absent reimbursement, processors may not be willing to incur additional transportation costs, and feeding organizations may lack the funding to cover these costs to facilitate the donation. The DDP aims to facilitate timely donations and reduce food waste. Therefore, this final rule continues to find the DDP should cover part of the transportation costs from the EDO to the eligible distributor. This may be especially beneficial to rural communities whose donation sites are often far from plants serving them and who may not receive assistance from other government feeding programs with distribution points closer to urban centers.

As the reimbursement value is paid to the EDO, the DDP only reimburses for transportation if the EDO incurred the expense. If donated eligible dairy products are picked up from the plant by the eligible distributor, no transportation reimbursement will be paid. Details of the transportation cost reimbursement rate are explained later in this rule.

Section 762(d)(2)(A) of the CAA specifies that total reimbursement—the sum of input, manufacturing, and transportation costs—must be set neither too high to “interfere with the commercial marketing of milk or dairy products” nor too low to “be sufficient to avoid food waste.” The statute further requires total reimbursement to be between the highest and lowest of the classified milk values. To ensure costs can be sufficiently covered for most donations, the interim final rule capped the total reimbursement payment, on a per cwt basis, at the Class I value for the highest FMMO differential zone (Dade County, Florida). Capping at the highest FMMO zone allowed for Class I handlers to obtain some reimbursement for manufacturing and transportation costs.

Section 762(d)(2)(B)(iv) of the CAA further allows the Secretary to maintain traditional price relationships—Class I being the highest, followed in sequence by II, III and IV—in setting the reimbursement rate. In 2020, dairy markets experienced pronounced class price inversions, where the Class III price was significantly higher than the Class I price in many areas of the country. However, the Class III price has been above the Class I price in Dade County, Florida, only three times since the current pricing system was adopted on January 1, 2000. 7 No extreme price inversions have occurred since the interim final rule was published, and such extreme inversions are not anticipated in the foreseeable future. While the DDP does not directly determine classified prices and price relationships, the interim final rule found that program rules should not exacerbate price inversions if they occur. In times of price inversion, where the Class I price is not the highest-class price, the interim final rule continued to cap total reimbursements at the Class I price for Dade County, Florida. This final rule continues to find the reimbursement cap appropriate.

Entities must submit Plan and Eligible Distributor Certification Forms (Certification Forms) to AMS for approval before they can submit Claim Forms for reimbursement. Reimbursement Claim Forms, along with supporting documentation, can be filed any time after the Plan is approved and the donation is made. AMS uses the supporting documentation to verify program requirements were met. Plans only need to be submitted once for approval. The DDP does not require annual Plan renewal.

Although program funds for the DDP and MDRP are statutorily prohibited from being consolidated, the two programs operate as one from a stakeholder standpoint. EDOs making Class I fluid milk product donations which are covered by both programs are reimbursed through MDRP funds at the difference between the Class I and lowest classified price and receive a supplemental reimbursement of the lowest classified price plus the manufacturing and transportation cost reimbursement through DDP funds. Total combined reimbursement is capped at the Class I price in Dade County, Florida.

EDOs already enrolled in MDRP were automatically enrolled in the DDP when the interim final rule became effective. Subsequently, they received supplementary payments for fluid milk products donated under their currently approved MDRP Plans.

Section 762(h) of the CAA requires supplementary payments be made to EDOs participating in the MDRP for donations made on or after January 1, 2020. Since the statute allows for retroactive reimbursement to those participating in the DDP, a retroactive date of January 1, 2020, was adopted in the interim final rule to apply to the DDP to streamline administration of the two programs. To ensure adequate availability of funds for donations made before enactment of the CAA, total program expenditures for eligible dairy product donations made from January 1, 2020, to December 27, 2020, were limited to no more than $50 million under the interim final rule. 8 A deadline for requesting retroactive reimbursement was posted on the AMS web page for the DDP, and roughly $712,000 in retroactive claims were submitted.

The following details the DDP provisions and amendments to the MDRP, where applicable.

The statute includes definitions for terms used. Section 1147.1 provides definitions for terms as they are used in the new program. Key terms are “eligible dairy organization,” “eligible dairy product,” “eligible distributor,” “eligible partnership,” and “qualified expense.” This final rule makes no changes to these definitions.

Eligible dairy organization (EDO). As explained in the Background section, section 762(a)(1) of the CAA adopts the same EDO definition contained in the statute establishing the MDRP. See Sec. 1431(a) and (b) of the Agricultural Act of 2014 (7 U.S.C. 9071(a)). The regulatory definition matches the statutory definition, which specifies that a dairy organization eligible to participate in the program is a dairy farmer, either individually or as part of a cooperative, or a dairy processor that: (1) accounts to an FMMO marketwide pool; and (2) incurs qualified expenses. See id.

Eligible dairy product. Section 762(a)(2) of the CAA specifies that only dairy products primarily made from milk, including fluid milk, produced and processed in the United States are eligible for donation and reimbursement under the DDP. Additional standards defining further requirements for eligible dairy products are described in the commodity specification provisions. Accordingly, § 1147.1 defines “eligible dairy product” as a dairy product meeting the commodity specifications referenced in § 1147.3.

Eligible distributor. Section 762(a)(3) of the CAA defines “eligible distributor” as “a public or private nonprofit organization that distributes donated eligible dairy products to recipient individuals and families.” Section 1147.1 likewise defines “eligible distributor” as a public or private non-profit feeding organization distributing, or coordinating the distribution of, donated eligible dairy products to recipient individuals and families. Eligible distributors such as food banks, shelters, kitchens, and other food distribution organizations are eligible so long as they are nonprofit entities. Under this program, participating eligible distributors fill out an Eligible Distributor Certification Form to verify their non-profit status and affirm they have appropriate facilities and processes for distributing donated dairy products to recipient individuals and families.

Eligible partnership. Section 762(c) of the CAA requires an EDO and eligible distributor form a partnership to participate in the DDP. Requiring parties to apply as a partnership ensures all program provisions are met and an agreed-upon structure is in place when eligible dairy products are available for donation and distribution. Section 762(a)(4) of the CAA defines “eligible partnership” as “a partnership between an eligible dairy organization and an eligible distributor,” and this rule continues to find the same definition appropriate.

AMS recognizes some EDOs may have processing plants in multiple locations reporting to different FMMOs. Similarly, eligible distributors may have multiple distribution sites; for example, several food pantries are operated by one umbrella organization. Thus, under § 1147.102(a), the eligible partnership can submit one Plan to cover multiple plants and/or distribution locations as long as only one EDO is represented.

Qualified expense. The statute does not define “qualified expense,” but does specify one needs to be incurred to be eligible for program participation. Section 1147.1 defines “qualified expense” as the cost incurred to purchase fresh fluid milk for processing into eligible dairy products or the cost incurred to purchase bulk dairy commodity products for further processing into eligible dairy products. A qualified expense is different than the reimbursement rate, which is described later in this final rule. Because defining “qualified expense” is fundamental to determining program eligibility and the MDRP and DDP reference the same “eligible dairy organization” statutory definition, the “qualified expense” definition was added to the MDRP regulation in the interim final rule and remains unchanged by this final rule.

Additional terms necessary for administration of the program are defined in § 1147.1. “Program” is defined as the Dairy Donation Program, and “Secretary” is defined as the Secretary of the United States Department of Agriculture or a representative authorized to act in the Secretary's stead.

The final rule amends the DDP's commodity specification provisions to expand applicability to eligible distributors, as explained below.

The DDP is intended to reimburse eligible dairy organizations for timely donations of eligible dairy products and minimize food waste. It is therefore reasonable to ensure eligible dairy products donated under the DDP meet minimum food safety and quality standards and are in package sizes desired by eligible distributors, consistent with the intent of the program to minimize food waste that might otherwise result. The final rule makes no changes to § 1147.3, which defines the program's commodity specifications.

The final rule continues to require that EDOs comply with all applicable Federal, State, and local laws, executive orders, and rules and regulations related to its performance under this program.

To qualify under the program, eligible dairy products must:

1. Be made primarily from cow's (bovine) milk produced in the United States;

2. Be packaged in consumer-sized packaging; and

3. Meet the applicable provisions for dairy products in the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et. seq. ), as amended. Grade `A' dairy products must meet the applicable provisions of the current edition of the Pasteurized Milk Ordinance  9 ; and

4. Have a sell-by, best-by, or use-by date no sooner than 12 days from the date the eligible dairy product is delivered to the eligible distributor.

Currently, bovine cow's milk is the only type of milk in surplus being dumped at the farm. Since the program is designed to prevent surplus milk from being dumped at the farm, it is the Secretary's discretion to limit the DDP to cow's (bovine) milk.

Program provisions also specify donated dairy products must be in consumer-sized packaging. This provision should be interpreted by the eligible partnership as to whatever consumer-sized package is agreeable to both entities. Examples of consumer-sized packaging include, but are not limited to, gallons of milk, 8-ounce blocks of cheese, single serve containers of yogurt, 1-pound packages of butter, or large bags of milk if the eligible distributor has the ability to dispense ( i.e., a soup kitchen). When submitting Plans for approval, the EDO is required to list what types of products it will be donating. The submitted information is checked against the distribution process explained by the eligible distributor to ensure it has the ability to distribute the types of products to be donated.

As explained below, this final rule makes no changes to the program eligibility and participation provisions, except for a modification of the Plan submission requirements designed to lessen the burden on participants.

Section 1147.100 requires an eligible dairy organization must be a member of a partnership whose Plan has been approved by AMS to be eligible for reimbursements under the DDP.

Section 1147.102 outlines requirements for Plan submission in order to be considered for the program. The interim final rule required the EDO to submit a Plan for each partnership. Upon administering the program, AMS found requiring an EDO to submit a separate Plan for each partnership overly burdensome to participants, as the EDO was submitting the same information about its operations on multiple Plans. Allowing Plans to cover multiple partnerships with the same EDO eliminates reporting redundancies, increases efficiencies, and reduces participant burden. Plans must continue to include a signed affirmation regarding the type of product to be donated and the EDO's ability to process and transport eligible dairy products consistent with the requirements in the commodity specifications under § 1147.3.

Along with the Plan submission, eligible distributors are required to submit a signed Certification Form, which includes a description of the eligible distributor's distribution process, contact information, and a tax identification number to ensure compliance with program provisions. AMS has found that details of a particular partnership-the EDO and the eligible distributor—are sufficiently covered in the information provided in the Eligible Distributor Certification Form. Accordingly, this final rule amends the regulations to allow the EDO to submit one Plan to cover all its partnerships and a separate Certification Form for each eligible distributor to AMS.

As specified in § 1147.208, AMS only collects information deemed necessary to determine whether an eligible partnership's Plan should be approved. All proprietary business information submitted is used only for the purposes of the program and kept confidential by AMS.

Section 1147.104 specifies the process AMS will continue to use to review and approve program applications. Within 15 business days of application submission, AMS reviews the Plan and Certification Form, determines whether to approve or disapprove, and notifies the eligible partnership of the determination. Under § 1147.104(a)(1), AMS reviews the information submitted by the partnership, including the signed affirmation that the partnership can meet the requirements related to proper processing, transport, storage, and distribution of eligible dairy products. Under § 1147.104(a)(2), AMS considers the extent to which the Plan would advance the statutory purposes of the DDP, namely, whether the Plan would facilitate the timely donation of eligible dairy products and prevent and minimize food waste. See Sec. 762(b) of the CAA.

Finally, section 762(c)(2)(B)(i) of the CAA specifies that priority review is given to submitted Plans where an emergency or disaster was a substantial factor, including a declared or renewed public health emergency under section 319 of the Public Health Service Act (42 U.S.C. 247(d)) or a disaster designated by the Secretary. In reviewing a Plan, AMS determines if an emergency or disaster was a substantial factor in the Plan's submission. In this case, “substantial factor” means that a supply and/or demand disruption caused by the emergency or disaster event is a main reason for the partnership submitting the Plan. For example, the COVID-19 public health emergency—which caused a significant decrease in school and restaurant dairy demand, leading to large volumes of displaced milk and many people in need of food assistance—could be considered a justification for priority review. If an emergency or disaster is deemed a substantial factor, AMS prioritizes review of that Plan to facilitate donations and meet an immediate need. Section 1147.104(a)(3) incorporates those factors for Plan prioritization.

Once approved, Plans do not need to be resubmitted in subsequent fiscal years, unless changes are made. Eligible partnerships that received reimbursement from the MDRP were automatically enrolled in the DDP when the program was implemented and became eligible to receive the supplemental reimbursement as defined in § 1147.109.

This final rule makes minor administrative changes to the Reimbursement Claim Form and subsequently the MDRP and DDP regulations, to ensure proper reimbursement rates. This rule continues to find the reimbursement price—the sum of input, transportation, and manufacturing costs—an appropriate reimbursement rate to meet program objectives.

Section 762(d) of the statute requires the Secretary to reimburse EDOs with approved Plans. Section 1147.106(a) provides the process and describes the necessary information and documentation AMS requires to verify the EDO's donation and calculate its reimbursement. To receive reimbursement, the EDO must complete and submit a Reimbursement Claim Form (Claim Form) that includes: the type, volume, and manufactured date of the eligible dairy products donated; the entity type (processor, co-pack facility, distribution center, or eligible distributor); the physical address(es) of the eligible dairy organization's processing plant(s), co-pack facility(ies), and distribution center(s), and the eligible distributor's distribution site(s); the universal product code(s) (UPCs) for donated product(s); the sell-by, best-by, or use-by date(s) for donated product(s); and the dates the donated dairy products were processed and shipped to the eligible distributor.

In administering the DDP since September 1, 2021, AMS learned some EDOs transport donated product to EDO-owned distribution centers before delivering to an eligible distributor as part of their normal business operations. As the DDP was designed to only reimburse for transportation from the last point of ownership by the EDO, obtaining information on a distribution center location, where applicable, is necessary to determine the accurate transportation reimbursement. Accordingly, this final rule adds “distribution center” as an additional entity type to the Claim Form in order to improve data accuracy and ensure proper reimbursement calculations.

There is no requirement dictating the frequency of Claim Form submissions; therefore, any time after its Plan is approved, the EDO can submit Claim Forms for donations made. The EDO also must provide adequate documentation, which should be available through its normal business records, to verify the eligible distributor received the donated eligible dairy products. Such documentation could include, but is not limited to, processing and shipping records, bills of lading, storage records, or receiving records from the eligible distributor. As specified in § 1147.208, AMS only collects the information and documentation needed to verify the EDO's reimbursement claim.

Section 762(d)(4) of the CAA allows the Secretary to make retroactive reimbursements to EDOs that donate eligible dairy products before their Plans are approved. As provided for in statute, eligible dairy products donated through the MDRP are eligible for supplemental reimbursement through DDP for donations made on or after January 1, 2020. To gain administrative efficiencies and streamline the two programs, donations of eligible dairy products through DDP beginning on the same date were also eligible for reimbursement by the interim final rule. Accordingly, § 1147.106(a)(3) provides for donations of eligible dairy products beginning on January 1, 2020, to be eligible for reimbursement. As described earlier, total reimbursement for donations made from January 1, 2020, through December 27, 2020, was capped at $50 million by the interim final rule. This cap was implemented to ensure equitable distribution of funds for that time period in case a large number of claims were submitted. Participating entities had 6 months to submit claims for this time period; only 20 claims were received and approximately $712,000 was reimbursed.

As authorized by section 762(d)(3)(B) of the CAA, AMS may verify the accuracy of supporting documentation with spot checks and audits under § 1147.206.

Under section 762(d)(2)(A) of the CAA, the Secretary shall set a reimbursement price that reflects the cost of the milk required to make the donated eligible dairy product, is between the FMMO Class I and Class IV minimum prices for the month of production, is sufficient to avoid food waste, and does not interfere with the commercial marketing of milk or dairy products. Section 1147.108 provides for reimbursement of three separate cost factors: (1) input cost—fluid milk product or bulk dairy commodity product milk-equivalent cost; (2) manufacturing cost of converting fluid milk into a product; and (3) transportation cost from the EDO to the eligible distributor. Section 1147.108(a) provides that reimbursements are the sum of the three cost factors.

For the first of these factors, input cost, processors purchasing and processing fresh fluid milk products (raw milk, skim milk, cream, or concentrated fluid products), are reimbursed at the applicable FMMO minimum classified skim and butterfat values. Processors purchasing bulk dairy commodity products for further processing into eligible dairy products are reimbursed at the applicable FMMO minimum classified skim and butterfat values for the fluid milk equivalent contained in the bulk product. This value is determined by the milk's end use (Class I for fluid milk products, Class II for soft products such as yogurt, Class III for cheese products, and Class IV for butter and powder products) pursuant to 7 CFR 1000.40 and the applicable classified price in effect for the month of production pursuant to 7 CFR 1000.50.

The manufacturing cost for processing fluid milk is represented by the applicable FMMO make allowances contained in 7 CFR 1000.50. The DDP uses the FMMO make allowances in the Class III and IV price formulas to reflect manufacturing costs for Class III and IV products, as they are based on surveyed cost data of wholesale Class III and IV products. The Department lacked data on manufacturing costs for Class I and II products. As such, the interim final rule adopted the lowest make allowance, Class IV, as the representative manufacturing costs and requested public comment on manufacturing costs for these classes of products. One comment was received. As explained in the Background section, the comment did not include full context on what the cost ranges represented. However, AMS finds it reasonable to conclude from the data submitted that Class I manufacturing costs are higher than the Class IV make allowance currently used. Upon further review, this final rule amends the Class I make allowance to be the average of the Class III and IV make allowances, as the Class I pricing formula is a function of the average of Class III and IV prices. Also discussed earlier, the Class IV make allowance will still apply for Class II products, as the Class II price is a function of the Class IV price. This final rule does not retroactively apply the amended make allowance for Class I products to reimbursements made prior to the implementation of this final rule. The new Class I make allowance will only apply to reimbursement of Class I products submitted after the implementation of this final rule.

As explained in the Background section, the program does not reimburse additional processing costs for bulk products purchased and further processed. Processors purchasing bulk dairy commodity products for further processing receive the same manufacturing cost reimbursement as described above. Processors buy bulk product on a per-pound basis, and it is reasonable to conclude the price paid represented both the fluid milk value (which they are being reimbursed for as described earlier) and the cost to convert the fluid milk into the bulk commodity. Therefore, eligible dairy products made from bulk dairy commodity products are only eligible to receive the manufacturing cost reimbursement applicable to fluid milk.

The transportation cost reimbursement is based on the U.S. monthly average diesel fuel price  10 for the month the donation was made, a fuel economy factor of 6.1 miles per gallon, 11 and the shortest hard-surface distance from the last point of EDO-ownership of the product to the eligible distributor's physical distribution location. The final rule clarifies that transportation cost reimbursement is from the last point of EDO-ownership, which does not necessarily mean from the plant where the product was produced. As a normal course of business, some processors transport product to an EDO-owned distribution center before delivering to the eligible distributor. To ensure efficient movements of product and proper application of transportation reimbursement, it is appropriate the EDO only receive reimbursement from the last point of ownership. Transportation reimbursement is only be paid if the EDO incurred the transportation cost, which is verified on audit.

Section 762(h) of the CAA requires the Secretary to make supplemental reimbursements to EDOs receiving reimbursements under the MDRP from January 1, 2020, to the date when DDP program funds are no longer available. AMS recognizes an EDO under MDRP is also eligible under DDP. Further, eligible dairy products under MDRP also qualify as eligible dairy products under DDP (notably, fluid milk products). Since DDP reimburses at a higher rate than MDRP, a supplemental reimbursement is needed to properly use funds for and fulfill the purposes of both programs. Section 1147.109 provides the process AMS follows to make a supplemental reimbursement to EDOs receiving reimbursement under MDRP. EDOs with already approved Plans under MDRP were automatically enrolled in DDP when the program was implemented and received supplemental reimbursements equal to the difference they received under MDRP and the reimbursement they would be eligible to receive for the same products under DDP, calculated in § 1147.108. New applicants to the DDP that donate fluid milk products will be automatically enrolled in MDRP. Upon approval, AMS makes reimbursements under the MDRP provisions and then supplemental reimbursements under the DDP provisions.

This final rule continues the administrative provisions without change.

Section 762(g) of the CAA requires AMS to publish donation activity for the program. Accordingly, § 1147.200 provides that AMS periodically reports on its publicly accessible website the aggregated donation activity under this program. Such information includes types and volume of product donated, as well as remaining available funds. Since April 2022, AMS has posted reports quarterly on its website, along with the Plan and Claim Form templates to be submitted for program participation.

Section 762(e) of the CAA prohibits the sale of eligible dairy products donated under the DDP back into commercial markets and specifies that eligible distributors who violate that prohibition will not be eligible for future participation in the DDP. Section 1147.204 implements the statutory prohibition and penalty for violation. In addition, the program prohibits reimbursement for donated eligible dairy products made in conjunction with marketing or promotional events.

Section 762(f) of the CAA directs the Secretary to conduct appropriate reviews or audits to ensure the integrity of the DDP. Under section 762(d)(3)(B) of the CAA, the Secretary is further authorized to verify the accuracy of submitted documentation through spot checks and audits. Section 1147.206 provides that AMS verifies the proper delivery of and payment for donated eligible dairy products. Specifically, AMS ensures the donated eligible dairy products were delivered to the eligible distributor and the accuracy of the reimbursed value paid to the EDO. The section further provides for the review, audit, and spot checks of information submitted.

As mentioned in the above discussions, § 1147.208 requires AMS to maintain confidentiality regarding information collected to administer the program and to use the information only for program purposes.

A books and records provision is included in § 1147.209 to ensure the EDO maintains necessary records to be made available to AMS upon request in conjunction with an audit.

Section 1147.210 specifies that dairy products sold or donated under any other USDA commodity purchase or donation program, other than the MDRP, are not eligible for reimbursement under the DDP. From time to time, USDA may purchase dairy products for use in nutrition assistance programs or other uses, but vendors are compensated for those purchases through funding under those program provisions. One of the main purposes of the DDP is to reduce food waste by encouraging the donation of additional dairy products through eligible distributors. Thus, EDOs who received compensation for dairy product purchases under other USDA programs may not receive reimbursements for the same dairy products under the DDP.

In accordance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. Chapter 35), AMS has requested approval of updated information collection and recordkeeping requirements for the DDP. AMS received no public comments on the Office of Management and Budget (OMB)-approved information collection portion of the interim final rule. AMS is now making three minor changes (described below) to lessen the burden on participants and increase administrative efficiencies.

Title: Dairy Donation Program Final Rule.

OMB Number: 0581-0327.

Expiration Date of Approval: Pending.

Type of Request: Approval of Updated Information Collection.

Abstract: The Consolidated Appropriations Act of 2021 (CAA) mandated establishment of a Dairy Donation Program (DDP) to reimburse eligible dairy organizations (EDO) for milk used to make eligible dairy products donated to non-profit groups for distribution to recipient individuals and families. Under the program, EDOs account to a Federal milk marketing order (FMMO) by filing a report with an FMMO. Entities not already filing an FMMO report will be required to submit a Report of Receipts and Utilization. The information collection burden is being changed to allow the report to be submitted once rather than every month donated products are manufactured as was originally implemented.

All EDOs must submit a Dairy Donation and Distribution Plan (Plan outlining their partnership(s) and products to be donated and, for each eligible distributor partner, an Eligible Distributor Certification Form (Certification Form) describing the process of transporting, storing, and distributing eligible product to an eligible distributor. Once approved, the EDO can file a Reimbursement Claim Form (Claim Form) to receive reimbursement for the donated eligible dairy products. Since the final rule allows for EDOs to include multiple partnerships on one Plan, whereas the interim final rule required EDOs to submit one Plan per partnership, the number of responses and reporting burden for the Plan will decrease. Further, due to this same change, the number of responses and reporting burden for the Claim Form will decrease because the EDO will no longer need to submit separate Claim Forms for each partnership.

Estimate of Burden: Public reporting burden for this collection of information is estimated to average 1 hour per response.

Respondents: Eligible dairy organizations.

Estimated Number of Respondents: 150.

Estimated Number of Responses: 150.

Estimated Number of Responses per Respondent: 1.

Estimated Total Annual Burden on Respondents: 150 hours.

Estimate of Burden: Public reporting burden for this collection of information is estimated to average 15 minutes per response.

Respondents: Eligible distributors.

Estimated Number of Respondents: 300.

Estimated Number of Responses: 300.

Estimated Number of Responses per Respondent: 1.

Estimated Total Annual Burden on Respondents: 75 hours.

Estimate of Burden: Public reporting burden for this collection of information is estimated to average 2 hours per response.

Respondents: Eligible dairy organizations.

Estimated Number of Respondents: 150.

Estimated Number of Responses: 600.

Estimated Number of Responses per Respondent: 4.

Estimated Total Annual Burden on Respondents: 1,200 hours.

Estimate of Burden: Public reporting burden for this collection of information is estimated to average 1 hour per response.

Respondents: Eligible dairy organizations.

Estimated Number of Respondents: 15.

Estimated Number of Responses: 15.

Estimated Number of Responses per Respondent: 1.

Estimated Total Annual Burden on Respondents: 15 hours.

Comments: No comments were received on the information collection in the interim final rule.

In the interim final rule, AMS estimated 150 respondents would form 2 partnerships on average for a total of 300 partnerships. In the first fiscal year of program operation, there were approximately 120 respondents that formed 280 partnerships.

Each EDO is required to submit a Plan, which can cover multiple partnerships with that EDO, and a Certification Form for each eligible distributor partner. These forms only need to be submitted once; there will not be an annual renewal requirement. AMS estimates 1 hour to complete a Plan. Accompanying the Plan, the EDO will be required to complete a Certification Form, which AMS anticipates will take 15 minutes.

AMS estimates 10 percent of the 150 EDO participants do not already account to an FMMO by filing a report. Therefore, approximately 15 respondents will need to account to an FMMO by filing a Report of Receipts and Utilization Form. All other EDOs have accounted to an FMMO through their normal report filing based on their existing association with an FMMO. AMS estimates 1 hour to complete the form. Filing of this form will not cause an EDO to become regulated by an FMMO.

Claim Forms can be submitted any time after Plan approval and will be processed on at least a quarterly basis. AMS estimated that to capture efficiencies respondents will submit Claim Forms no more than once per quarter and it will take 2 hours to complete the form per quarter.

Assuming the reporting burden will be completed by an administrative assistant employee, at an hourly salary rate of $21.70  12 , AMS estimates the following annual reporting costs per participant, assuming two eligible distributor partners per EDO: for the first year of participation, the annualized cost is $206.15 (one Plan, two Certification Forms, and four Claim Forms); for the subsequent years of participation, the annualized cost is $173.60 (four Claim Forms). Entities needing to account to an FMMO by filing a Report of Receipts and Utilization Form will experience an additional annual burden of $21.70 in the first year only (one response). EDOs also are required to maintain books and records for 3 years to be made available to AMS upon request in conjunction with an audit to verify the donations the EDO received reimbursement for were made. These records are part of normal business records and do not require additional records to be created. Such records include production records to verify yield computations and product code dates for donated manufactured products, or delivery documentation to verify the EDO incurred a transportation expense.

USDA is committed to complying with the E-Government Act (44 U.S.C. 3601, et seq. ) by promoting the use of the internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes. Forms can be found at http://www.ams.usda.gov/ddp and filed through email at ddp@usda.gov.

Section 762 of the Consolidated Appropriations Act of 2021 mandates that AMS establish and administer a Dairy Donation Program (7 CFR part 1147). The program is intended to facilitate the timely donation of eligible dairy products and prevent and minimize food waste.

USDA is issuing this rule in conformance with Executive Orders 12866 and 13563, which direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health, and safety effects; distributive impacts; and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. AMS has determined this action, mandated by Congress, meets the requirements set forth in the Consolidated Appropriations Act of 2021 to facilitate donation of eligible dairy products and prevent and minimize food waste.

The interim final rule sought public comment on the economic impacts of this action on the industry, including availability of information or data that may demonstrate if and how DDP reimbursements affect the market. As discussed earlier, AMS received four comments, of which three were germane to this rulemaking. One comment was received on manufacturing costs for Class I and II products. Another comment requested additional flexibility concerning reporting requirements. One additional comment expressed support of the positive economic impact the program has on the dairy industry and consumers alike.

Regarding regional economic differences, AMS considered alternative methods for allocating available funds under the program, including whether to allocate reimbursements equally across all the geographic areas of the United States or to target specific regions in need of milk donations. Ultimately, AMS determined that because the program's primary purpose is to reduce waste associated with the disposition of surplus milk, the industry would be best served by allowing those with the capacity to process surplus milk and who are in a position to make donations to apply for the program without consideration of geographic location.

AMS continues to find that this rule does not have any quantified cost or benefits, rather the rule results in transfers consistent with the following table, adjusted from the interim final rule with actual expenditures during the first fiscal year of program operation and accordingly, an expanded range for the time period covered. As participants become more accustomed to the program and due to the decreased burden for participants in subsequent years after their Plans are approved, AMS reasonably expects the transfer value to increase 25 percent, year-over-year, for the first 7 years, and held constant in the out years.

As the program is voluntary, eligible partnerships are expected to participate if they deem it beneficial depending on their individual circumstances. The transfers will be reimbursements in the form of Federal payments to program participants to help offset costs associated with eligible dairy product donations.

In the normal course of transporting, delivering, and processing milk, a small volume of milk is “lost” each month. In the FMMO system, “normal losses” are estimated to be 0.25 percent of the total participating milk annually. Under certain conditions, an additional volume of milk cannot make it to market due to extraordinary circumstances, such as extreme weather, plant capacity issues, and market disruptions. This volume above “normal losses” is identified as “excess losses” in this analysis.

According to FMMO statistics, “excess losses” averaged 0.08 percent of the annual volume of milk participating in the FMMO program from 2015 through 2019, excluding the outlying pandemic-influenced years of 2020 and 2021. During these years, the COVID-19 pandemic resulted in higher levels of milk not making it to market, amounting to 0.32 and 0.27 percent, respectively, of the milk that participated in the FMMO program. In the interim final rule, AMS included 2020 in the “excess loss” average, but 2020 distorted the value, leading to an overestimate of the amount of milk available to be made into donated products for normal years. In conducting an economic analysis, AMS presumed milk classified as “excess losses” could be made into eligible dairy products and donated under the DDP.

To estimate the volume of excess milk potentially donated under the program in this final rule, a 5-year average rate of 0.08 percent for 2015-2019 period is applied to the projected 2023 U.S. milk production volume. Under this assumption, approximately 183 million pounds of milk would be available for dairy processors to make into eligible dairy products for donation to eligible distributors. As in the interim final rule, AMS lacks data to estimate the amount of bulk commodity product available for secondary processors to purchase and further process into eligible dairy products for donation to eligible distributors, so that scenario is not considered in the economic analysis.

AMS estimated the amounts of butterfat and skim solids in the forecasted product volumes available for donation. The product mix includes fluid milk, soft products, cheese, butter, and nonfat dry milk powder volumes, based on the volume of available dairy farmer milk. The set of products utilizes nearly all the butterfat and skim solids present in the milk available for donation. In the case of butter and nonfat dry milk powder, both products can be made from a given amount of milk. Butter requires a large amount of butterfat, while powder utilizes very little butterfat but a large amount of the nonfat solids.

The DDP reimburses EDOs for eligible dairy product donations for the input cost paid for the fluid milk or bulk dairy commodity product, manufacturing cost, and transportation cost. In the interim final rule, AMS estimated the maximum annual reimbursement value given the program's parameters that total reimbursement must be between the highest FMMO Class I value (Dade County, Florida) and the Class IV value (assumed the lowest classified value). Using the same methodology, AMS estimates a maximum reimbursement value of $63 million, using forecasted 2023 FMMO class prices and volume available for donation based on the .08 percent excess loss assumption and USDA's November 2022 World Agricultural Supply and Demand Estimates (WASDE).

In practice, AMS expects actual reimbursement expenditures to be lower. During the first year of operation, DDP expended $5,834,353, 13 representing 22,562,669 pounds of donated dairy products (equivalent to 27,576,312 milk pounds). Therefore, for this final rule, AMS determines it more appropriate to estimate annual DDP expenditures based on actual spending. Accordingly, expenditures are estimated to be 125 percent of the previous year and held constant after 7 years. This is a reasonable assumption given reduced participant burden and increased awareness and familiarity with the program is expected to increase participation.

In addition, normal fluctuation in market prices may contribute to increased donations in times of low milk prices, and subsequently higher program expenditures. For example, it is normal for excess milk to be made into storable products such as butter. Relatively high butter prices in 2022 indicated a tight butter market resulting in excess milk made into butter to be sold in the marketplace instead of donated through the DDP. USDA expects butter prices to be lower in 2023, as compared to 2022, due to weaker demand and lower international prices, thus increasing DDP expenditures as the possibility rises that surplus milk used for butter is made available for donation.

As described above, AMS estimates that 183 million pounds (0.08 percent of projected 2023 production) of excess milk could be available to be processed and donated through the DDP. Consequently, AMS does not anticipate this small additional processing volume will impact milk prices. AMS anticipates dairy processors already donating dairy products to non-profit feeding organizations will become eligible for reimbursement through DDP. These donations are not new production volume to be priced as they represent dairy products already processed and priced somewhere in the dairy supply chain. The DDP does not intend to reimburse for the full cost of processing and delivering donated dairy products but rather encourages excess milk to be used.

This program is expected to have a negligible impact on retail dairy product sales. Typically, populations that receive dairy products from non-profit feeding organizations do so when they cannot buy dairy products at retail outlets. Since the DDP reimbursement rate does not cover all processing and transportation costs it is not a financially prudent decision to divert milk from retail outlets to donations. The following table provides examples of costs included and excluded from reimbursement under the DDP. This is not an all-inclusive listing but is intended to demonstrate how dairy product donations through this program are not expected to be a substitute for retail dairy product sales.

In addition, DDP is a voluntary program and reimbursements occur after donations are made. Donations made through this program are made privately without donation volumes being announced in advance, reducing the impact on dairy markets compared to making advanced announcements on expected donation volume.

Pursuant to the requirements set forth in the Regulatory Flexibility Act (5 U.S.C. 601-612), AMS has considered the economic impact of the action on small entities. Accordingly, AMS prepared this Regulatory Flexibility Analysis (RFA).

The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions so small businesses will not be unduly or disproportionately burdened. Small dairy farms are defined by the Small Business Administration (SBA) (13 CFR 121.201) as those businesses having annual gross receipts of $3.75 million or less. The SBA's definition of small agricultural service firms, which includes dairy processors, varies based on the type of dairy product manufactured. Small dairy processors are defined as having between 750 and 1,250 or fewer employees depending on the products made.

According to the 2017 USDA National Agricultural Statistics Service (NASS) Census Report, the most recent report, there were 39,303 farms with milk sales. AMS estimates 36,158 farms, or 92 percent, are considered small businesses. Dairy farmers of all sizes may benefit from the program as it encourages donations of dairy products which contain milk purchased from them. DDP is designed to reduce food waste by providing alternative outlets for milk to be utilized in donated products instead of being dumped due to oversupply. Often milk is dumped from smaller dairy farms that are more costly to service because their pickups may be less than a full tanker load and/or they may be located farther from major trucking routes. By providing cost reimbursement for donated products, the DDP incentivizes processors to pick up and process the milk into products for donation rather than having it dumped.

AMS estimates approximately 3,000 plants, owned by approximately 1,500 entities, manufacture dairy products in the United States. According to AMS calculations, about 10 percent are operated by dairy farmer cooperatives, while the remaining are independently owned. AMS believes 1,500 to be the universe of EDOs that could participate in the DDP. Of the potential EDOs, 90 percent would be considered small businesses based on total employee numbers.

Participating in the DDP will not unduly or disproportionately burden small dairy processing entities. All entities, regardless of size, can apply for the program if they file a report with an FMMO and incur a qualified expense as defined by program provisions. Program provisions are administered without regard to business size. The paperwork required to participate asks for information that is part of normal business records.

The definition of an eligible distributor is a public or private non-profit feeding organization that distributes or coordinates distribution of donated eligible dairy products to recipient individuals and families. Eligible distributors, regardless of size, can voluntarily participate in the DDP if they form a partnership with an EDO. The information collection burden for eligible distributors is minimal as they must only complete the Certification Form with the partnering EDO. The voluntary nature of the program allows any eligible distributor to stop participating if they find the program causes an undue or disproportionate burden.

AMS has determined this program does not have a significant economic impact on small entities. Program provisions are applied uniformly to both large and small businesses and are not expected to burden small entities unduly or disproportionately.

In the interim final rule, AMS assessed the impact of this program on Indian Tribes and determined it would not have Tribal implications requiring consultation under Executive Order 13175. Since the final rule does not include any changes affecting Tribal implications of the DDP, additional review is not necessary. Executive Order 13175 requires Federal agencies to consult and coordinate with Tribes on a government-to-government basis on: (1) policies that have Tribal implication, including regulation, legislative comments, or proposed legislation; and (2) other policy statements or actions that have substantial direct effects on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes.

Tribal governments operating non-profit organizations feeding recipient individuals and families can qualify as eligible distributors and thus benefit from participation in the DDP. The regulatory burden from participating is minimal, estimated at 15 minutes for completing an Eligible Distributor Certification Form.

AMS hosts a quarterly teleconference with Tribal leaders where matters of mutual interest regarding the marketing of agricultural products are discussed. Information about the final rule will be shared in an upcoming quarterly call. AMS will continue to work with the USDA Office of Tribal Relations to ensure meaningful consultation is provided as needed with regards to the DDP.

The interim final rule was reviewed under Executive Order 12988—Civil Justice Reform. Since the final rule does not include any changes affecting the civil justice implications of the DDP, additional review is not necessary. This final rule may have a retroactive effect. Claims submitted after the effective date of this final rule for donations made starting January 1, 2020, are eligible for reimbursement under this rule's amended provisions if the eligible partnership's Dairy Donation and Distribution Plan is approved and if the partnership met all other program requirements. Dairy donations made prior to 2020 are not eligible for reimbursement under the program. The provisions amended by this final rule are not retroactive to Claims already submitted and processed prior to this rule's effective date. There are no administrative procedures that must be exhausted prior to judicial challenges to the provisions of this rule. The DDP does not preempt any state or local laws, regulations, or policies, unless they present an irreconcilable conflict with this rule.

AMS considered the potential civil rights implications of this rule on minorities, women, and persons with disabilities to ensure no person or group shall be discriminated against on the basis of race, color, national origin, gender, religion, age, disability, sexual orientation, marital or family status, political beliefs, parental status, or protected genetic information. This review included persons that are employees of the entities who are subject to these regulations. This final rule does not require affected entities to relocate or alter their operations in ways adversely affecting such persons or groups. Further, this rule does not deny any persons or groups the benefits of the program or subject any persons or groups to discrimination.

AMS found no evidence this voluntary program and the associated final rule causes adverse or disproportionate impacts on minorities, women, and persons with disabilities. The AMS analysis found no evidence of potential impacts affecting dairy farmers or processors in any protected groups, or that these impacts will be different than any participating general population of dairy farmers and processors.

AMS examined the effects of provisions in this final rule on the relationship between the Federal Government and the States, as required by Executive Order 13132 on “Federalism.” The DDP reimburses EDOs for eligible dairy products donated to eligible distributors. The DDP does not preempt any State or local laws, regulations, or policies pertaining to the sale, manufacturing or distribution of milk or dairy products within States.

For the reasons set forth in the preamble, 7 CFR chapter X is amended as follows:

The NRC is amending its regulations in parts 1, 2, 26, 32, 40, 50, 51, 52, 72, and 73 of title 10 of the Code of Federal Regulations (10 CFR). The NRC is making these amendments to update organizational information, revise an address, and correct reference, spelling, and grammatical errors. This rule also makes updates to replace gendered terms with inclusive, gender-neutral language.

Update Organization and Functions. In § 1.42 concerning the Office of Nuclear Material Safety and Safeguards, this final rule revises the introductory text for paragraph (b)(26). The rule also revises paragraph (b)(30) to list financial assurance activities and adds a new paragraph (b)(33) to list duties for environmental activities. This final rule updates the regulations to align more closely with Commission direction in SRM-SECY-15-0143, “Project Aim and Centers of Expertise,” dated February 22, 2016 (Agencywide Documents Access and Management System ML16053A500) regarding Centers of Expertise.

Update Organizational Functions. In § 1.43, this final rule moves responsibility for review and evaluation related to reactor facilities insurance, indemnity, and antitrust matters from the Office of Nuclear Reactor Regulation to the Office of Nuclear Material Safety and Safeguards.

Revise Nomenclature. This final rule revises 10 CFR part 2 to replace gendered terms with inclusive, gender-neutral language.

Correct Reference. In § 2.1202(a)(1), this final rule removes the incorrect reference to 10 CFR 50.12 and replaces it with the correct reference 10 CFR 50.10.

Revise Street Address. This final rule amends §§  26.11, 50.4(a), 52.3(a), and 73.4(b) to add the mailing zip code for the hand delivery method for communications.

Correct Reference. In 10 CFR 32.72(a)(2)(i), this final rule removes the incorrect reference to 21 CFR 207.20 and replaces it with the correct reference 21 CFR 207.17(a).

Correct Spelling. This final rule amends Appendix A to part 40 to remove the text “meterology” and add in its place the text “meteorology.”

Correct Typographical Error. This final rule removes a duplicative phrase in the introductory text of § 50.55a(b)(2)(xliii).

Correct Reference. This final rule reverts an inadvertent change to a reference in Appendix H paragraph III.B.1 that occurred during a direct final rulemaking (85 FR 62199) by removing the incorrect reference to ASTM E 185 and replacing it with ASTM E 185-82.

Correct Reference. In § 51.77(a), this final rule removes the incorrect reference to appendix M and replaces it with the correct reference subpart F.

Correct Spelling. This final rule amends § 72.3 to remove the text “radioacive” and add in its place the text “radioactive.”

Correct Grammatical Error. In § 73.50, this final rule adds the indefinite article “a” before the words “nuclear reactor” in the introductory text.

Under section 553(b) of the Administrative Procedure Act (5 U.S.C. 553(b)), an agency may waive publication in the Federal Register of a notice of proposed rulemaking and opportunity for comment requirements if it finds, for good cause, that it is impracticable, unnecessary, or contrary to the public interest. As authorized by 5 U.S.C. 553(b)(3)(B), the NRC finds good cause to waive notice and opportunity for comment on these amendments, because notice and opportunity for comment is unnecessary. The amendments will have no substantive impact and are of a minor and administrative nature dealing with corrections to certain CFR sections or are related only to management, organization, procedure, and practice. Specifically, the revisions update organizational information and correct references, grammatical and spelling errors, and make updates to replace gendered terms with inclusive, gender-neutral language. The NRC is exercising its authority under 5 U.S.C. 553(b) to publish these amendments as a final rule. The amendments are effective September 25, 2023. These amendments do not require action by any person or entity regulated by the NRC and do not change the substantive responsibilities of any person or entity regulated by the NRC.

The NRC has determined that the corrections in this final rule would not constitute backfitting as defined in §  50.109, “Backfitting,” and as described in NRC Management Directive (MD) 8.4, “Management of Backfitting, Forward Fitting, Issue Finality, and Information Requests.” These corrections also would not constitute forward fitting as that term is defined and described in MD 8.4 or affect the issue finality of any approval issued under 10 CFR part 52. The amendments are non-substantive in nature, and include updates to organizational information, corrections to references, grammatical errors and spelling, and make updates to replace gendered terms with inclusive, gender-neutral language. They impose no new requirements and make no substantive changes to the regulations. The corrections do not involve any provisions that would impose backfits as defined in 10 CFR chapter I, or that would be inconsistent with the issue finality provisions in 10 CFR part 52. For these reasons, the issuance of this final rule would not constitute backfitting or be inconsistent with any of the issue finality provisions in 10 CFR part 52. Therefore, the NRC has not prepared any additional documentation for this correction rulemaking addressing backfitting or issue finality.

The Plain Writing Act of 2010 (Pub. L. 111-274) requires Federal agencies to write documents in a clear, concise, and well-organized manner. The NRC has written this document to be consistent with the Plain Writing Act as well as the Presidential Memorandum, “Plain Language in Government Writing,” published June 10, 1998 (63 FR 31885).

The NRC has determined that this final rule is the type of action described in §  51.22(c)(2), which categorically excludes from environmental review rules that are corrective or of a minor or nonpolicy nature and do not substantially modify existing regulations. Therefore, neither an environmental impact statement nor an environmental assessment has been prepared for this rule.

This final rule does not contain a collection of information as defined in the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ) and, therefore, is not subject to the requirements of the Paperwork Reduction Act of 1995.

This final rule is not a rule as defined in the Congressional Review Act (5 U.S.C. 801-808).

Under the “Agreement State Program Policy Statement” approved by the Commission on October 2, 2017, and published in the Federal Register (82 FR 48535), NRC program elements (including regulations) required for adequacy and having a particular health and safety component are those that are designated as Categories A, B, C, D, NRC, and H&S: and those required for compatibility include those regulations and other legally binding requirements designated as Compatibility Categories A, B, C, and D. Compatibility Category A are those program elements that include basic radiation protection standards and scientific terms and definitions that are necessary to understand radiation protection concepts. An Agreement State should adopt Category A program elements in an essentially identical manner in order to provide uniformity in the regulation of agreement material on a nationwide basis. Compatibility Category B are those program elements that apply to activities that have direct and significant effects in multiple jurisdictions. Compatibility Category B pertains to a limited number of program elements that cross jurisdictional boundaries and should be addressed to ensure uniformity of regulation on a nationwide basis. The Agreement State program element should be essentially identical to that of NRC. Compatibility Category C are those program elements that do not meet the criteria of Category A or B, but the essential objectives of which an Agreement State should adopt to avoid conflict, duplication, gaps, or other conditions that would jeopardize an orderly pattern in the regulation of agreement material on a national basis. An Agreement State should adopt the essential objectives of the Category C program elements. Compatibility Category D are those program elements that do not meet any of the criteria of Category A, B, or C, above, and, thus, do not need to be adopted by Agreement States for purposes of compatibility. Compatibility Category NRC are those program elements that address areas of regulation that cannot be relinquished to the Agreement States under the Atomic Energy Act of 1954, as amended, or provisions of title 10 of the Code of Federal Regulations. These program elements should not be adopted by the Agreement States. Category H&S program elements are not required for purposes of compatibility; however, they do have particular health and safety significance. The Agreement State should adopt the essential objectives of such program elements to maintain an adequate program.

The final rule is a matter of compatibility between the NRC and the Agreement States, thereby providing consistency among Agreement State and NRC requirements. The compatibility categories are designated in the following table:

For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; and 5 U.S.C. 552 and 553, the NRC is adopting the following amendments to 10 CFR parts 1, 2, 26, 32, 40, 50, 51, 52, 72, and 73.

On September 27, 2022, the EEOC published in the Federal Register a Notice of Proposed Rulemaking (“NPRM”) announcing its intention to amend 29 CFR part 1614 by authorizing the EEOC, the Office of Federal Operations (“OFO”), and the EEOC's Administrative Judges (“AJs”) to issue and receive documents electronically instead of, or in addition to, using first class U.S. mail (“first class mail”). Currently, 29 CFR 1614.109(i) provides that an AJ “shall send copies of the hearing . . . decision to the parties.” Section 1614.405(a) requires that a Commission appellate decision be “transmitted to the complainant and the agency by first class mail.” The NPRM proposed authorizing the Commission to transmit its hearing and appellate decisions, orders, and related documents to registered complainants through the EEOC Electronic Public Portal (“Public Portal” or “Portal”). It also was proposed that complainants could file hearing requests, appeals, and related documents through the Portal. The NPRM further proposed requiring agencies to notify complainants that they can use the Public Portal to file hearing requests and appeals. Finally, the NPRM asked commenters to address when an EEOC decision transmitted through the Portal should be considered to be received.

The final rule formalizes the current use of electronic communications between the EEOC and its stakeholders by explicitly providing for the digital transmission of complaint files, hearing requests and associated documents, appeals and associated documents, and Commission decisions. The final rule confirms that the digital receipt of hearing requests, appeals, Commission hearing and appellate decisions, and related documents, is equivalent to receipt by first class mail. Nevertheless, the final rule makes clear that a complainant's use of the Portal is voluntary.

Thus, for complainants who choose not to establish a Portal account, or who establish an account but do not agree to receive EEOC communications only through the Portal, OFO will use first class mail to communicate with, and send documents to, complainants, even while transmitting the same documents to agencies via FedSEP (the EEOC's separate electronic Portal for agency-only use); AJs also will use email to transmit documents. These same complainants will be able to file hearing requests, appeals, and related documents through the current methods available (first class and registered mail, facsimile, personal delivery, and email).

The EEOC received five comments about the NPRM, four from individuals and one from an attorney organization (“organization”). The commentors generally favor authorizing the EEOC and its AJs to transmit decisions and orders through the Portal. They also approve of allowing complainants to use the Portal to transmit hearing and appellate requests and documents. The organization opposes certain proposals while it and some of the individuals recommend specific modifications. Most provided suggestions regarding determining a receipt date for Portal-transmitted decisions.

The NPRM provided that, where a complainant registers with the Portal, the EEOC will communicate with the complainant only through the Portal unless and until the complainant informs the EEOC that they want to receive EEOC documents by first class mail. The organization argues for a final rule specifying that a complainant will receive documents electronically only after the complainant affirmatively consents, or opts-in, to receive documents through the Portal. It further proposes that, even when providing consent, the complainant should retain the option to send and receive documents by other methods, such as first class mail, in addition to receiving these same documents through the Portal. To this end, the organization proposes that a final rule should require agencies and the EEOC to provide complainants with relevant contact information for all filing methods during all stages of the complaint process.

The EEOC agrees that complainants who establish Portal accounts should be given an opportunity to affirmatively declare whether they agree to receive documents only through the Portal. A functionality will be added to the Portal for complainants to indicate this preference. Complainants who do not give their consent will receive OFO communications through first class mail and AJ communications through first class mail or email (if they provide an email address). However, the EEOC does not think it efficient to continue to use first class mail or other methods of communicating after a complainant affirmatively agrees to communicate via the Portal. Receipt by OFO of documents in the same matter through multiple means will complicate OFO recordkeeping, increase expenses, and cause delays.

Regarding addressing the various ways a complainant may communicate with an agency, the EEOC declines to implement the organization's recommendations as they exceed the scope of this rule. The EEOC did not intend to address in this rulemaking either an agency's communication methods with a complainant or a complainant's communication methods with an agency. Absent an opportunity for public comment on these matters, it is not appropriate to address them in this final rule.

As noted earlier, the NPRM specifically asked commenters to suggest when a decision or other document sent through the Portal should be deemed to be received by the complainant. Three individuals suggest that the receipt date should be the date the decision is first accessed by the complainant, regardless of when it is uploaded to the Portal. Two of these individuals stated that if the EEOC uses a standard such as, “a decision is deemed to be received within X days of when it is uploaded to the Portal,” the rule also should state that this presumption does not apply if the EEOC learns that the decision “did not reach the person to be served.”

The organization suggests creating two separate rules regarding receipt dates, depending on whether only the Portal is used, or email is used as well. If only email is used, the organization favors a rebuttable receipt date of seven days from the date of the email. If only the Portal is used, receipt should be deemed to occur when the complainant downloads the document. If both means of transmittal are used, the receipt date should be the date the decision is accessed via the Portal or email, or seven days after the email is sent, whichever occurs first.

The EEOC appreciates receiving these suggestions about a receipt date and concludes that it will address this topic based on these submissions. The final rule borrows from some of the comments and 29 CFR 1614.604(b), which deems receipt of regular mail to occur within five days of when a document is mailed. Thus, for Portal, email, and all other digital communications, the final rule provides that receipt is deemed to occur when a document is accessed on the Portal or received via electronic means, or within 5 days of when a document is uploaded to the Portal or transmitted electronically, whichever occurs first. Further, 29 CFR 1614.604(c), which allows equitable tolling of time frames, will apply to all transmissions, digital or otherwise. Finally, 29 CFR 1614.605(d) provides that receipt of a document is calculated from the complainant's receipt, unless the complainant is represented by an attorney, in which case the attorney's receipt controls. This provision requires no edits to apply to digital receipts.

The organization discusses difficulties it and its clients have had with certain features of the Portal. The organization offers a number of proposed technical enhancements to the Portal designed to make the Portal more user-friendly. These suggestions, while helpful, are not the proper subject matter for this final rule. Nevertheless, the EEOC will continue to work with its stakeholders to improve the functionality of the Public Portal (and FedSEP).

The Commission has complied with the principles in section 1(b) of Executive Order 12866, Regulatory Planning and Review. This NPRM is not a “significant regulatory action” under section 3(f) of the order and does not require an assessment of potential costs and benefits under section 6(a)(3) of the order.

The Paperwork Reduction Act (44 U.S.C. chapter 35) applies to rulemakings in which an agency creates a new paperwork burden on regulated entities or modifies an existing burden. This final rule contains no new information collection requirements on the public, and therefore, it creates no new paperwork burdens or modifications to existing burdens subject to review by the Office of Management and Budget.

The Commission certifies under 5 U.S.C. 605(b) that this NPRM will not have a significant economic impact on a substantial number of small entities because it applies exclusively to employees, applicants for employment, and agencies of the Federal Government and does not impose a burden on any business entities. For this reason, a regulatory flexibility analysis is not required.

This NPRM 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, and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

This NPRM does not substantially affect the rights or obligations of non-agency parties and, accordingly, it is not a “rule” pursuant to the Congressional Review Act. Therefore, the reporting requirement of 5 U.S.C. 801 does not apply.

Accordingly, for the reasons set forth in the preamble, the Equal Employment Opportunity Commission amends chapter XIV of title 29 of the Code of Federal Regulations as follows:

ONRR published a direct final rule in the Federal Register on December 8, 2011 (76 FR 76612). ONRR amended the thermal energy displaced equation in § 1206.356(a)(2) from “0.113681” to “0.133681.” Section 1206.356(a)(2) contained an image of the equation for illustration purposes. However, ONRR did not provide an updated equation image. This document provides the correct equation image.

Accordingly, ONRR amends 30 CFR part 1206 by making the following correcting amendment.

The Coast Guard will enforce a Safety Zone; for the Annual Event in the Captain of the Port Buffalo Zone, listed in 33 CFR 165.939, Table 165.939(d)(3) for the Head of the Cuyahoga in Cleveland, Ohio. All U.S. waters of the Cuyahoga River, between a line drawn perpendicular to the river banks from position 41°29′55″ N, 081°42′23″ W (NAD 83) just past the Detroit-Superior Viaduct bridge at MM 1.42 of the Cuyahoga River south to a line drawn perpendicular to the river banks at position 41°28′32″ N, 081°40′16″ W (NAD 83) just south of the Interstate 490 bridge at MM 4.79 of the Cuyahoga River.

Pursuant to 33 CFR 165.23, entry into, transiting, or anchoring within the safety zone during an enforcement period is prohibited unless authorized by the Captain of the Port Buffalo or a designated representative. Those seeking permission to enter the safety zone may request permission from the Captain of Port Buffalo via channel 16, VHF-FM. Vessels and persons granted permission to enter the safety zone shall obey the directions of the Captain of the Port Buffalo or a designated representative. While within a safety zone, all vessels shall operate at the minimum speed necessary to maintain a safe course.

This notice of enforcement is issued under authority of 33 CFR 165.939 and 5 U.S.C. 552(a). In addition to this notice of enforcement in the Federal Register , the Coast Guard will provide the maritime community with advance notification of this enforcement period via Broadcast Notice to Mariners or Local Notice to Mariners. If the Captain of the Port Buffalo determines that the safety zone need not be enforced for the full duration stated in this notice, he may use a Broadcast Notice to Mariners to grant general permission to enter the respective safety zone.

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

The background for this action is discussed in detail in our April 21, 2023, proposal (88 FR 24518). In that document we proposed to approve portions of three revisions to the Texas SIP submitted by the TCEQ on July 9, 2021, and January 21, 2022. The first revision, adopted on April 22, 2020, submitted on January 21, 2022, updates internal cross-references and removes or replaces obsolete provisions identified during a routine review of the Texas permitting regulations. The second revision, adopted on June 9, 2021, submitted July 9, 2021, repeals obsolete permitting provisions, and makes necessary corresponding edits to other permitting provisions. The third revision, adopted on August 25, 2021, submitted January 21, 2022, enhances the public notice requirements of the air permitting program. As detailed in our proposed approval, we found that the submitted revisions are consistent with the CAA and the EPA's regulations, policy, and guidance for permitting SIP requirements. We did not receive any comments regarding our proposal. Therefore, we are finalizing as proposed.

Pursuant to section 110, of the Act, we are finalizing the submitted revisions to the Texas SIP that update the air permitting program by removing obsolete provisions and enhancing public notice by extending requirements for alternative language notices to notices for public meetings in certain circumstances.

We are approving the following revisions adopted on June 9, 2021, effective on July 1, 2021, submitted to the EPA on July 9, 2021:

• Revisions to 30 TAC Section 116.910—Applicability,

• Revisions to 30 TAC Section 116.911—Electric Generating Facility Permit Application,

• Revisions to 30 TAC Sections 116.920—Public Participation for Initial Issuance,

• Revisions to 30 TAC Sections 116.1530—Best Available Retrofit Technology (BART) Control Implementation, and

• Repeal of 30 TAC Sections 116.770—116.772, 116.774, 116.775, 116.777—116.781, 116.783, 116.785—116.788, and 116.790.

The EPA is approving the following revisions adopted on April 22, 2020, effective on May 14, 2020, submitted to the EPA on January 21, 2022:

• Revisions to 30 TAC Section 39.405—General Notice Provisions,

• Revisions to 30 TAC Section 39.411—Text of Public Notice,

• Revisions to 30 TAC Section 39.419—Notice of Application and Preliminary Decision,

• Revisions to 30 TAC Section 39.420—Transmittal of the Executive Director's Response to Comments and Decision,

• Revisions to 30 TAC Section 39.601—Applicability,

• Revisions to 30 TAC Section 39.603—Newspaper Notice,

• Revisions to 30 TAC Section 55.154—Public Meetings,

• Revisions to 30 TAC Section 55.156—Public Comment Processing,

• Revisions to 30 TAC Section 101.306—Emission Credit Use,

• Revisions to 30 TAC Section 116.111—General Application, and

• Revisions to 30 TAC Section 116.112—Distance Limitations.

The EPA is approving the following revisions adopted on August 25, 2021, effective September 16, 2021, submitted to the EPA on January 21, 2022:

• Revisions to 30 TAC Section 39.405—General Notice Provisions,

• Revisions to 30 TAC Section 39.412—Combined Notice for Certain Greenhouse Gases Permit Applications,

• Revisions to 30 TAC Section 39.418—Notice of Receipt of Application and Intent to Obtain Permit,

• Revisions to 30 TAC Section 39.419—Notice of Application and Preliminary Decision,

• New 30 TAC Section 39.426—Alternative Language Requirements,

• Revisions to 30 TAC Section 39.602—Mailed Notice,

• Revisions to 30 TAC Section 39.604—Sign-Posting,

• Revisions to 30 TAC Sections 55.154—Public Meetings, and

• Revisions to 30 TAC Sections 55.156—Public Comment Processing.

The EPA is also correcting several errors identified in the amendatory language for the Texas SIP at 40 CFR 52.2270(c). The EPA is making these necessary, ministerial edits to the Texas SIP without notice and comment under the “good cause” exemption in section 553(b)(3)(B) of the Administrative Procedures Act (APA) which, upon finding “good cause,” authorizes agencies to dispense with public participation. Under section 553 of the APA, an agency may find good cause where procedures are “impractical, unnecessary, or contrary to the public interest.” Public comment is “unnecessary” and “contrary to the public interest” since the ministerial corrections update the amendatory language at 40 CFR 52.2270(c) to correctly reference prior EPA actions that were previously subject to notice and comment consistent with section 553 of the APA. The public benefits by having these updated citations.

• The EPA's January 11, 2011, final rule at 76 FR 1525, 1531-1532, inadvertently used the wrong section names in the Title/Subject field for several of the section numbers that were approved into the Texas SIP. We are correcting the Title/Subject field for 30 TAC Sections 116.911, 116.912, 116.916, 116.917, 116.918, 116.920, 116.930.

• The EPA's February 13, 2020, final rule at 85 FR 8185, 8188, inadvertently omitted the information identifying the EPA's approval date from the SIP-approved sections for 30 TAC Sections 116.164, 116.196, 116.198, 116.310, 116.611, and 116.615. We are correcting these sections to include the EPA approval date and FR citation.

The EPA reviewed demographic data and provided the results in our April 21, 2023, proposed rule. See 88 FR 24518, 24520-24521.

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 revisions to the Texas regulations as described in Section II of this preamble, Final Action. The EPA has made, and will continue to make, these materials generally available through www.regulations.gov (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information). Therefore, these materials have been approved by EPA for inclusion in the SIP, have been incorporated by reference by EPA into that plan, are fully federally enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking of EPA's approval, and will be incorporated in the next update to the SIP compilation.

Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Clean Air Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, 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 14094 (88 FR 21879, April 11, 2023);

• 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 subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because it approves a state program;

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

• 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.

Executive Order 12898 (Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations, 59 FR 7629, February 16, 1994) directs Federal agencies to identify and address “disproportionately high and adverse human health or environmental effects” of their actions on minority populations and low-income populations to the greatest extent practicable and permitted by law. The EPA defines environmental justice (EJ) as “the fair treatment and meaningful involvement of all people regardless of race, color, national origin, or income with respect to the development, implementation, and enforcement of environmental laws, regulations, and policies.” The EPA further defines the term fair treatment to mean that “no group of people should bear a disproportionate burden of environmental harms and risks, including those resulting from the negative environmental consequences of industrial, governmental, and commercial operations or programs and policies.”

The state air agency did not evaluate environmental justice considerations as part of its SIP submittal; the CAA and applicable implementing regulations neither prohibit nor require such an evaluation. The EPA performed an environmental justice analysis, as is described above in the section titled, “Environmental Justice Considerations.” The analysis was done for the purpose of providing additional context and information about this rulemaking to the public, not as a basis of the action. Due to the nature of the action being taken here, this action is expected to have a neutral to positive impact on the air quality of the affected area. In addition, there is no information in the record upon which this decision is based inconsistent with the stated goal of E.O. 12898 of achieving environmental justice for people of color, low-income populations, and Indigenous peoples.

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).

This action is subject to the Congressional Review Act, and the EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. 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 October 23, 2023. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

For the reasons stated in the preamble, the Environmental Protection Agency amends 40 CFR part 52 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 Office of the Federal Register's e-CFR site at https://www.ecfr.gov/current/title-40.

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-2020-0004 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 October 23, 2023. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b), although the Office of Administrative Law Judges encourages parties to file electronically. See https://www.epa.gov/sites/default/files/2020-05/documents/2020-04-10_-_order_urging_electronic_service_and_filing.pdf.

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-2020-0004, 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 March 3, 2020 (85 FR 12454) (FRL-10005-58), 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 9F8809) by Nichino America, Inc., 4550 Linden Hill Road, Suite 501, Wilmington, DE 19808. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the herbicide pyraclonil, 1-(3-chloro-4,5,6,7-tetrahydropyrazolo[1,5- a ]pyridin-2-yl)-5-[methyl(prop-2-ynyl)amino]pyrazole-4-carbonitrile, in or on rice, grain at 0.01 parts per million (ppm). That document referenced a summary of the petition prepared by Nichino America, Inc., the registrant, which is available in the docket https://www.regulations.gov. Three comments supporting the registration were improperly filed in the docket for the notice of filing (NOF); there were no comments on the tolerance action.

Based upon review of the data supporting the petition, EPA has recommended changes to the tolerance expression. The reason for these changes 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 therein, 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 pyraclonil including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with pyraclonil follows.

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

The target organs of pyraclonil are the liver and the thyroid. Liver effects were found to be primarily adaptive (increased weight, hepatocellular hypertrophy, induction of cytochrome P450); however, female mice showed adverse liver effects (clinical chemistry changes, increased liver weight, and fat deposits after 90 days of oral exposure; these initial changes progressed to cellular alteration, liver masses, and hepatocellular adenomas after 78 weeks of oral exposure). Thyroid effects occurred in rats at similar doses across the database via oral exposures (lowest observed adverse effect levels (LOAELs) range from 74 to 207 mg/kg/day). Thyroid follicular cell hypertrophy was observed in both sexes of rats in several studies, after 14 or more days of oral exposure. Colloid degeneration was observed in both sexes, and thyroid follicular cell adenomas were observed in males in a chronic study. Increased blood levels of thyroid stimulating hormone (TSH) and decreased levels of thyroxine (T4) were detected after 1, 2, 52, and 104 weeks of oral exposure (hormones only measured in one 14-day oral study and one chronic study), in either or both sexes. No thyroid effects were detected in mice or dogs.

No reproductive effects were detected. No increased pre- or postnatal susceptibility was detected. Pup weights were decreased in the rat reproductive study at the same dietary concentration at which thyroid effects were observed in adults. Decreased fetal weights were seen in a rat developmental study at the same dose as maternal clinical signs and decreased body weight. In an acute neurotoxicity study, decreased motor activity and several functional observation battery (FOB) findings (tremors, hunchback posture and slight lacrimation; decreased alertness, exploration, approach response and landing foot splay; and decreased body temperature) were noted only at 2 hours post-dosing with a single dose of 400 mg/kg in females, and at higher doses in males. There was no effect of treatment on neurological parameters measured in a 90-day repeat dose studies in the rat.

Pyraclonil is classified as “Likely to be Carcinogenic to Humans”, based on treatment-related hepatocellular tumors in female mice (adenomas and combined adenomas/carcinomas), and thyroid follicular cell tumors in male rat (adenomas and combined adenomas/carcinomas). The unit risk, Q1* (mg/kg/day) −1 of pyraclonil based upon female mouse liver tumor rates is 1.08 × 10 −2 in human equivalents.

Specific information on the studies received and the nature of the adverse effects caused by pyraclonil 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 https://www.regulations.gov in document Pyraclonil. Human Health Risk Assessment for the New Active Ingredient for use on Rice at 11-14 in docket ID number EPA-HQ-OPP-2020-0004.

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

A summary of the toxicological endpoints for pyraclonil used for human risk assessment can be found on pages 18-20 in the Pyraclonil Human Health Risk Assessment.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to pyraclonil, EPA considered exposure under the petitioned-for tolerances. EPA assessed dietary exposures from pyraclonil 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 pyraclonil. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 2005-2010 National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in food, EPA conducted an unrefined acute dietary exposure assessment for the proposed new use on rice and assumed 100 percent crop treated (PCT), tolerance-level residues and default processing factors.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 2005-2010 NHANES/WWEIA. As to residue levels in food, EPA conducted an unrefined chronic dietary exposure assessment for the proposed new use on rice and assumed 100 PCT, tolerance-level residues and default processing factors.

iii. Cancer. EPA determines whether quantitative cancer exposure and risk assessments are appropriate for a food-use pesticide based on the weight of the evidence from cancer studies and other relevant data. If quantitative cancer risk assessment is appropriate, cancer risk may be quantified using a linear or nonlinear approach. If sufficient information on the carcinogenic mode of action is available, a threshold or nonlinear approach is used and a cancer RfD is calculated based on an earlier noncancer key event. If carcinogenic mode of action data are not available, or if the mode of action data determines a mutagenic mode of action, a default linear cancer slope factor approach is utilized. Based on the data summarized in Unit III.A., EPA has concluded that pyraclonil should be classified as “Likely to be Carcinogenic to Humans” and a linear approach has been used to quantify cancer risk. The inputs for the cancer dietary exposure assessment and the chronic dietary exposure assessment were equivalent with the exception of the estimated drinking water concentrations (EDWC) used. Applying the Q1* of 1.08 × 10 −2 (mg/kg/day) −1 to the exposure value (0.000136 mg/kg/day) results in a cancer risk estimate of 1 × 10 −6 for adults 20 to 49 years old.

iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use anticipated residue and/or PCT information in the dietary assessment for pyraclonil. Tolerance level residues and/or 100PCT 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 pyraclonil in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of pyraclonil. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/models-pesticide-risk-assessment.

Based on the Pesticides in Flooded Application Model (PFAM version 2.0), the maximum EDWCs of 50.8 µg/L for the 1-in-10-year daily mean, 6.68 µg/L for the 1-in-10-year annual mean, and 6.40 µg/L for the 30-year annual mean concentration in surface water were used in the acute, chronic, and cancer analyses, respectively.

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). Pyraclonil is not registered for any specific use patterns that would result in residential exposure.

4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

EPA has not found pyraclonil to share a common mechanism of toxicity with any other substances, and pyraclonil does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that pyraclonil 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 https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act (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. No increased pre- or postnatal susceptibility was detected in developmental studies in rats or rabbits, or in a reproductive study in rats.

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

i. The toxicity database for pyraclonil is complete.

ii. Potential evidence of neurotoxicity was observed in the pyraclonil acute neurotoxicity study; however, concern is low since a clear NOAEL was established and the selected endpoints are protective of the observed effects.

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

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

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 pyraclonil will occupy <1% of the aPAD for all infants <1 year old, the population group receiving the greatest exposure.

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

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

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

4. Aggregate cancer risk for U.S. population. The estimated exposure of adults 20 to 49 years old (the most highly exposed adult subpopulation) to pyraclonil is 0.000136 mg/kg/day. Applying the Q1* of 1.08 × 10 −2 (mg/kg/day) −1 to the exposure value results in a cancer risk estimate of 1 × 10 −6 for adults 20 to 49 years old. EPA generally considers cancer risks (expressed as the probability of an increased cancer case) in the range of 1 in 1 million (or × 10 −6 ) or less to be negligible. The precision which can be assumed for cancer risk estimates is best described by rounding to the nearest integral order of magnitude on the logarithmic scale; for example, risks falling between 3 × 10 −7 and 3 × 10 −6 are expressed as risks in the range of 10 −6 . This is particularly the case where some conservatism is maintained in the exposure assessment. The pyraclonil exposure assessment is unrefined and retains significant conservatism in that tolerance-level residues and 100 percent crop treated is assumed for the rice use. In addition, EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to pyraclonil in drinking water. These assessments will not underestimate the exposure posed by pyraclonil. Accordingly, EPA has concluded the aggregate cancer risk for all existing pyraclonil uses and the new uses in this action fall within the range of 1 × 10 −6 and are thus negligible.

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

Adequate enforcement methodology such as high-performance liquid chromatography method with tandem mass spectrometry detection (LC/MS/MS), Method GLP-MTH-108, 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 a MRL for pyraclonil.

The Agency is establishing a tolerance for residues of pyraclonil expressed as: (1-(3-chloro-4,5,6,7-tetrahydropyrazolo[1,5- a ]pyridin-2-yl)-5-(methyl-2-propyn-1-ylamino)-1 H -pyrazole-4-carbonitrile), which is the CAS name, rather than the petitioned for expression of pyraclonil: 1-(3-chloro-4,5,6,7-tetrahydropyrazolo[1,5- a ]pyridin-2-yl)-5-[methyl(prop-2-ynyl)amino]pyrazole-4-carbonitrile, which is the IUPAC name.

Therefore, tolerances are established for residues of pyraclonil, 1-(3-chloro-4,5,6,7-tetrahydropyrazolo[1,5- a ]pyridin-2-yl)-5-(methyl-2-propyn-1-ylamino)-1 H -pyrazole-4-carbonitrile, in or on rice, grain at 0.01 ppm.

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

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

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

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

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

Therefore, for the reasons stated in the preamble, EPA is amending 40 CFR chapter I 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 Federal Register Office's e-CFR site at https://www.ecfr.gov/current/title-40.

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-2022-0577 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 October 23, 2023. 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-2022-0577, 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 September 23, 2022 (87 FR 58047) (FRL-9410-05-OCSPP), 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 2E9009) by BASF Corporation, 26 Davis Drive, Research Triangle Park, NC 27709-3528. The petition requested that 40 CFR 180.500 be amended by establishing tolerances for residues of the herbicide imazapyr, (2-[4,5-dihydro- 4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2- yl]-3-pyridinecarboxylic acid), in or on rice, bran at 0.2 parts per million (ppm) and rice, grain at 0.06 ppm. That document referenced a summary of the petition prepared by BASF Corporation, the registrant, which is available in the docket, https://www.regulations.gov. There were no comments received in response to the notice of filing.

Based upon review of the data supporting the petition, EPA is establishing one tolerance at a different level than requested by the registrant. The reason for these changes are 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 imazapyr including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with imazapyr 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.

No hazard was identified for imazapyr in the toxicity database, i.e., no toxicity was demonstrated in acceptable guideline studies generally up to the highest doses tested of 250-1,000 mg/kg/day. The data also show that there is no evidence of neurotoxicity, immunotoxicity, genotoxicity, or carcinogenicity. Further, no adverse developmental effects or adverse reproductive effects were detected in well-conducted guideline studies. Therefore, EPA concluded that dietary, occupational, and residential exposures to imazapyr do not pose a significant human health risk. Although there is potential for exposure to imazapyr, no hazard was identified from the well-conducted toxicity studies. No adverse effects were observed in the submitted toxicological studies regardless of the route of exposure or the species tested. Therefore, risk assessments are not required. Furthermore, the toxicology database is considered to be adequate, and no additional studies are required.

Specific information on the studies received and the nature of the adverse effects caused by imazapyr 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 https://www.regulations.gov in document titled “Imazapyr Human Health Risks Assessment for the Establishment of Permanent Tolerances for Residues in/on Rice” (hereinafter “Imazapyr Human Health Risk Assessment”) on pages 12-15 in docket ID number EPA-HQ-OPP-2022-0577.

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 the NOAEL and the 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 https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.

Since no effects were seen in any guideline toxicity studies at doses relevant for human health risk assessment, no toxicological points of departure (PODs) were selected for imazapyr.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to imazapyr, EPA considered exposure under the petitioned-for tolerances as well as all existing imazapyr tolerances in 40 CFR 180.500. There is likely to be dietary exposure to imazapyr from its registered uses as a pesticide on domestic crops. Should exposure occur, however, minimal to no risk is expected for the general U.S population, including infants and children, due to the low toxicity of imazapyr.

2. Dietary exposure from drinking water. While there is no additional exposure expected from imazapyr tolerances for rice because it is for import only, there is likely to be dietary exposure to imazapyr in drinking water from its registered uses as a pesticide on domestic crops. Should exposure occur, however, minimal to no risk is expected for the general U.S population, including infants and children, due to the low toxicity of imazapyr.

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).

Imazapyr is currently registered in the United States for application in/around the home (homeowner application permitted) and to noncropland areas, aquatic sites, grasslands, and imidazolinone-tolerant field corn. Due to the low toxicity of imazapyr, quantitative exposure assessments are not required. Residential exposure to imazapyr is not expected to increase with this tolerance because these tolerances are for import only. EPA concludes with reasonable certainty that non-occupational exposures to imazapyr do not pose a significant human health risk.

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 imazapyr and any other substances. For the purposes of this action, therefore, EPA has not assumed that imazapyr has a common mechanism of toxicity with other substances. Further information regarding EPA Pesticide Commulative Risk Assessment can be found at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/pesticide-cumulative-risk-assessment-framework.

1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Agency 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. Conclusion. No hazard was identified from the toxicity studies. No adverse effects were observed in the submitted toxicological studies regardless of the route of exposure or the species tested. The toxicology database for imazapyr is considered to be adequate. No additional toxicological studies are required, and no additional safety factors to protect children are needed and EPA is not retaining the 10X safety factor.

Taking into account the available data for imazapyr, EPA has concluded that given the lack of toxicity of this substance, no risks of concern are expected. Therefore, 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 imazapyr.

Adequate enforcement methodology (high-performance liquid chromatography with tandem mass spectroscopy (LC/MS/MS), method SOP-PA.0288) is available for tolerance enforcement.

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 has not established a MRL for imazapyr in or on rice.

EPA is establishing the tolerance for rice, bran at 0.15 ppm rather than at 0.2 ppm as requested by the petitioner. The rice, bran tolerance is based on the highest average field trial residue (0.031 ppm) and the median rice bran processing factor of 3.2x. (0.031 ppm × 3.2 = 0.099 ppm). The tolerance is being established at 0.15 ppm because that is the rounding class after 0.1 ppm. For the rice grain tolerance of 0.06 ppm, EPA used the Organization for Economic Co-operation and Development (OECD) maximum residue limit (MRL) calculation procedures.

Therefore, tolerances are established for residues of imazapyr (2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1 H -imidazol-2-yl]-3-pyridinecarboxylic acid), in or on rice, bran at 0.15 ppm and rice, grain at 0.06 ppm.

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

Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the 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 Office of the Federal Register's e-CFR site at https://www.ecfr.gov/current/title-40.

Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2022-0797 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 October 23, 2023. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b), although EPA strongly encourages those interested in submitting objections or a hearing request to submit objections and hearing requests electronically. See Order Urging Electronic Service and Filing (April 10, 2020), https://www.epa.gov/sites/default/files/2020-05/documents/2020-04-10_-_order_urging_electronic_service_and_filing.pdf. At this time, because of the COVID-19 pandemic, the judges and staff of the Office of Administrative Law Judges are working remotely and not able to accept filings or correspondence by courier, personal delivery, or commercial delivery, and the ability to receive filings or correspondence by U.S. Mail is similarly limited. When submitting documents to the U.S. EPA Office of Administrative Law Judges (OALJ), a person should utilize the OALJ e-filing system at https://yosemite.epa.gov/oa/eab/eab-alj_upload.nsf.

Although EPA's regulations require submission via U.S. Mail or hand delivery, EPA intends to treat submissions filed via electronic means as properly filed submissions during this time that the Agency continues to maximize telework due to the pandemic; therefore, EPA believes the preference for submission via electronic means will not be prejudicial. If it is impossible for a person to submit documents electronically or receive service electronically, e.g., the person does not have any access to a computer, the person shall so advise OALJ by contacting the Hearing Clerk at (202) 564-6281. If a person is without access to a computer and must file documents by U.S. Mail, the person shall notify the Hearing Clerk every time it files a document in such a manner. The address for mailing documents is U.S. Environmental Protection Agency, Office of Administrative Law Judges, Mail Code 1900R, 1200 Pennsylvania Ave. NW, Washington, DC 20460.

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-2022-0797, 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 February 23, 2023 (88 FR 11401) (FRL-10579-01), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance exemption petition (PP 1E8975) by IR-4, North Carolina State University, 1730 Varsity Drive, Suite 210, Venture IV, Raleigh, NC 27606, on behalf of the Texas Corn Producers Board, 4205 N Interstate 27, Lubbock, Texas 79403. The petition requested that 40 CFR 180.1338 be amended to establish an amendment of the existing temporary tolerance exemptions for the microbial pesticides Aspergillus flavus strains TC16F, TC35C, TC38B, and TC46G in or on all food and feed commodities of field corn, popcorn, and sweet corn. That notice referenced a summary of the petition prepared by the petitioner IR-4 and available in the docket via https://www.regulations.gov. EPA received no comments in response to the notice of filing.

EPA modified language from the requested tolerance exemption and changed “exemption” to “exemptions” in the amended tolerance exemption expression. The reason for this change is explained in Unit III.C.

Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement of a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.” Section 408(c)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings but does not include occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in FFDCA section 408(b)(2)(C), which require EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance or tolerance exemption and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .” Additionally, FFDCA section 408(b)(2)(D) requires that EPA consider “available information concerning the cumulative effects of [a particular pesticide's] . . . residues and other substances that have a common mechanism of toxicity.”

EPA evaluated the available toxicological and exposure data on Aspergillus flavus strains TC16F, TC35C, TC38B, and TC46G and considered their validity, completeness, and reliability, as well as the relationship of this information to human risk. A full explanation of the data upon which EPA relied and its risk assessment based on those data can be found within the document entitled “Human Health Risk Assessment of Aspergillus flavus strain TC16F, Aspergillus flavus strain TC35C, Aspergillus flavus strain TC38B, and Aspergillus flavus strain TC46G, New Active Ingredients, in FourSure Proposed for Registration and an Associated Petition Requesting a Tolerance Exemption” (Human Health Risk Assessment of Aspergillus flavus strains TC16F, TC35C, TC38B, and TC46G). This document, as well as other relevant information, is available in the docket for this action as described under ADDRESSES .

The toxicological profiles of Aspergillus flavus strains TC16F, TC35C, TC38B, and TC46G were previously described in the “Review of Product Identity, Human Health Data, and Petition for a Temporary Tolerance Exemption for the IR-4 and Texas Corn Producers Board FourSure Experimental Use Permit 5E8397,” available in docket EPA-HQ-OPP-2015-0742 and remain unchanged at this time. Based upon its evaluation, EPA concludes that, with regard to humans, Aspergillus flavus strains TC16F, TC35C, TC38B, and TC46G are not anticipated to be toxic, pathogenic, or infective via any reasonably foreseeable route of exposure. Although there is potential for dietary and non-occupational exposure to residues of Aspergillus flavus strains TC16F, TC35C, TC38B, and TC46G, there is not a concern due to the lack of potential for adverse effects. Because there are no threshold levels of concern with the toxicity, pathogenicity, or infectivity of Aspergillus flavus strains TC16F, TC35C, TC38B, and TC46G, EPA determined that no additional margin of safety is necessary to protect infants and children as part of the qualitative assessment conducted.

Based upon its evaluation in the Human Health Risk Assessment of Aspergillus flavus strains TC16F, TC35C, TC38B, and TC46G, which concludes that there are no risks of concern from aggregate exposure to Aspergillus flavus strains TC16F, TC35C, TC38B, and TC46G, EPA concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of Aspergillus flavus strains TC16F, TC35C, TC38B, and TC46G.

An analytical method is not required for Aspergillus flavus strains TC16F, TC35C, TC38B, and TC46G because EPA is amending temporary exemptions from the requirement of a tolerance without any numerical limitations.

One modification was made to the requested tolerance exemption. EPA changed “exemption” to “exemptions” as four different active ingredients are covered with this action.

Therefore, the existing Aspergillus flavus strains TC16F, TC35C, TC38B, and TC46G temporary tolerance exemptions are amended by establishing permanent tolerance exemptions for residues of Aspergillus flavus strains TC16F, TC35C, TC38B, and TC46G in or on all food and feed commodities of corn, field; corn, pop; and corn, sweet when used in accordance with label directions and good agricultural practices.

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

This action directly regulates growers, food processors, food handlers, and food retailers, not States or Tribes. As a result, this action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, EPA has determined that this action will not have a substantial direct effect on States or Tribal governments, on the relationship between the National Government and the States or Tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, EPA has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal governments” (65 FR 67249, November 9, 2000), do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (2 U.S.C. 1501 et seq. ).

This action does not involve any technical standards that would require EPA's consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (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, for the reasons stated in the preamble, EPA is amending 40 CFR chapter I as follows: