This action, pursuant to 5 U.S.C. 553, proposes to amend regulations issued to carry out a marketing order as defined in 7 CFR 900.2(j). This proposed rule is issued under Marketing Order No. 905, as amended (7 CFR part 905), regulating the handling of oranges, grapefruit, tangerines, and pummelos grown in Florida. Part 905 (referred to as “the Order”) is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.” The Committee locally administers the Order and is comprised of growers of fresh citrus operating within the area of production, and one public member.

The Agricultural Marketing Service (AMS) is issuing this proposed rule in conformance with Executive Order 12866, as amended by Executive Order 13563. Executive Orders 12866 and 13563 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. This action falls within a category of regulatory actions that the Office of Management and Budget (OMB) exempted from Executive Order 12866 review.

This proposed rule has been reviewed under Executive Order 13175, “Consultation and Coordination with Indian Tribal Governments,” which requires Federal agencies to consider whether their rulemaking actions would have Tribal implications. AMS has determined that this proposed rule is unlikely to 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.

This proposed rule has been reviewed under Executive Order 12988, “Civil Justice Reform.” Under the Order now in effect, Florida citrus handlers are subject to assessments. Funds to administer the Order are derived from such assessments. It is intended that the proposed assessment rate would be applicable to all assessable Florida citrus for the 2024-2025 fiscal period, and continue until amended, suspended, or terminated.

The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with the U.S. Department of Agriculture (USDA) a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. Such handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.

This proposed rule would increase the assessment rate for Florida citrus handled under the Order from $0.02 to $0.025 per 4/5 -bushel carton or equivalent, for the 2024-2025 and subsequent fiscal periods.

Sections 905.40 and 905.41 of the Order authorize the Committee, with the approval of AMS, to formulate an annual budget of expenses and collect assessments from handlers to administer the program. The members of the Committee are familiar with the Committee's needs and with the costs of goods and services in their local area and, thus, can formulate an appropriate budget and assessment rate. The assessment rate is formulated and discussed in a public meeting, and all directly affected persons have an opportunity to participate and provide input.

For the 2023-2024 and subsequent fiscal periods, the Committee recommended, and AMS approved, an assessment rate of $0.02 per 4/5 -bushel carton of citrus or equivalent. That rate continues in effect from fiscal period to fiscal period until modified, suspended, or terminated by AMS upon recommendation and information submitted by the Committee or other information available to AMS.

The Committee met on September 23, 2024, and unanimously recommended 2024-2025 fiscal period expenditures of $119,624 and an increased assessment rate of $0.025 per 4/5 -bushel carton of citrus or equivalent handled for the 2024-2025 fiscal period and subsequent fiscal periods. In comparison, budgeted expenditures for the 2023-2024 fiscal year were $124,624. The proposed assessment rate of $0.025 is $0.005 higher than the rate currently in effect. The Committee recommended increasing the assessment rate to reduce the burden on its financial reserve, which had been strained during the previous two seasons after unexpected, decreased shipment volumes. Following Hurricanes Helene and Milton, the Committee met again on November 14, 2024, and reaffirmed its recommendation for an assessment rate increase to help respond to damage incurred by both weather events. The Committee estimates shipments of approximately 4,500,000 4/5 -bushel cartons of citrus or equivalent for the 2024-2025 fiscal period, which is 1,145,904 fewer cartons than was handled for the 2023-2024 fiscal period.

The major expenditures recommended by the Committee for the 2024-2025 fiscal period include management, auditing, and compliance travel expenses—the same as budgeted for the 2023-2024 fiscal period.

The Committee derived the recommended assessment rate by considering anticipated expenses, an estimated 4,500,000 4/5 -bushel cartons or equivalent of assessable Florida citrus, and the amount of funds available in the authorized reserve. At the current assessment rate of $0.02, the expected 4,500,000 4/5 -bushel cartons or equivalent of the assessable Florida citrus would generate $90,000 in assessment revenue (4,500,000 cartons multiplied by the $0.02 assessment rate), which would require the use of $29,624 of reserves to cover the anticipated expenditures of $119,624 for the 2024-2025 fiscal period. By increasing the assessment rate by $0.005 to $0.025, assessment revenue would generate $112,500 (4,500,000 cartons multiplied by the $0.025 assessment rate) for the 2024-2025 fiscal period and would only require $7,124 in reserves to cover expenditures. Income derived from handler assessments, along with reserve funds and interest income, would be sufficient to meet the Committee's recommended budgeted expenditures of $119,624 for the 2024-2025 fiscal period. Funds available in the reserve (approximately $146,000) are expected to be kept within the maximum permitted by the Order (approximately two fiscal periods' expenses as authorized in § 905.42).

The proposed assessment rate would continue in effect indefinitely unless modified, suspended, or terminated by AMS upon recommendation and information submitted by the Committee or other available information. Although this assessment rate would be in effect for an indefinite period, the Committee will continue to meet prior to or during each fiscal period to recommend a budget of expenses and consider recommendations for modification of the assessment rate. The dates and times of Committee meetings are available from the Committee or AMS. Committee meetings are open to the public and interested persons may express their views at these meetings. AMS will evaluate Committee recommendations and other available information to determine whether modification of the assessment rate is needed. Further rulemaking would be undertaken as necessary. The Committee's 2024-2025 fiscal period budget, and those for subsequent fiscal periods, will be reviewed and, as appropriate, approved by AMS.

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

The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and the rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf.

There are 12 handlers of Florida citrus who are subject to regulation under the Order and approximately 500 citrus producers in the regulated area. At the time this analysis was prepared, the Small Business Administration (SBA) defined small agricultural producers as those having annual receipts equal to or less than $4.0 million for orange producers (North American Industry Classification System (NAICS) code 111310), and $4.25 million for other citrus producers (including grapefruit) (NAICS code 111320). Small agricultural service firms, including handlers, are defined as those whose annual receipts are equal to or less than $34.0 million (NAICS 115114) (13 CFR 121.201).

According to the data from the National Agricultural Statistic Service (NASS), the average free on board (FOB) price for fresh Florida oranges for the 2023-2024 season was approximately $18.15 per carton with total shipments of 3,504,000 cartons for a total value of $63,597,600. The average FOB price for fresh Florida grapefruit for the 2023-2024 season was $22.75 per carton with total fresh shipments of 1,201,000 cartons for a total value of $54,645,000. Based on this information, the majority of fresh citrus handlers have average annual receipts less than $34,000,000 ($63,597,600 plus $54,645,500 equals $118,243,100 divided by 12 handlers equals $9,853,591.67).

In addition, based on the NASS data, the on-tree price for growers for the 2023-2024 season was estimated at a weighted average price of $4.51 per carton. Fresh oranges make up a small segment of the citrus industry. The on-tree price for fresh oranges was $7.93 per carton with shipments of 3,504,000 cartons for a value of $27,786,720, while oranges for processing were $4.14 per carton with shipments of 32,416,000 cartons for a total value of $134,040,160.

Conversely, the grapefruit market is predominantly fresh. The on-tree price for fresh grapefruit was $13.44 per carton during the same period with shipments of 2,402,000 for a total value of $32,282,880. NASS could not estimate an on-tree price for processing. Based on grower prices, shipment data, and the total number of Florida growers, the average annual grower revenue, even including oranges for processing, is well below $4,000,000 ($27,786,720 in fresh orange shipments plus $134,040,160 in processed orange shipments, plus $32,282,880 in fresh grapefruit shipments equals $194,109,760 divided by 500 growers equals $388,219). Thus, the majority of Florida citrus handlers and growers may be classified as small entities.

This proposed rule would increase the assessment rate for the 2024-2025 fiscal year and subsequent fiscal years from $0.02 to $0.025 per 4/5 -bushel carton of citrus or equivalent. The Committee recommended 2024-2025 expenditures of $119,624 and an assessment rate of $0.025 per 4/5 -bushel carton. The proposed assessment rate of $0.025 is $0.005 more than the current assessment rate. The quantity of assessable Florida citrus for the 2024-2025 season is estimated at 4,500,000 4/5 -bushel cartons or equivalent. The $0.025 rate should provide $112,500 in assessment income (4,500,000 cartons multiplied by $0.025 assessment rate). Income derived from handler assessments along with reserve funds and interest income, should provide sufficient funds to cover budget expenses.

The major expenditures recommended by the Committee for the 2023-2024 fiscal year include management, auditing, and compliance travel expenses—the same as budgeted for the 2023-2024 fiscal period.

The Committee recommended increasing the assessment rate to minimize the use of reserves after drawing down these funds over the past two seasons due to shipment volumes and assessment being lower than expected. The Committee estimates shipments of approximately 4,500,000 4/5 -bushel cartons of citrus or equivalent for the 2024-2025 fiscal year which is 1,145,904 fewer cartons than was handled for the 2023-2024 fiscal year. At the current assessment rate of $0.02, the expected 4,500,000 4/5 -bushel cartons or equivalent of the assessable Florida citrus would generate $90,000 (4,500,000 cartons multiplied by $0.02 assessment rate), which would require the use of close to $30,000 of reserves to cover the anticipated expenditures of $119,624 for the 2024-2025 fiscal period. By increasing the assessment rate by $0.005 to $0.025, assessment income would generate $112,500 (4,500,000 cartons multiplied by $0.025 assessment rate) for the 2024-2025 fiscal year and require the use of less reserve funds to cover expenditures. The increased assessment amount, along with reserve funds and interest income, should provide sufficient funds to meet anticipated expenses for the 2024-2025 fiscal period.

Prior to arriving at this budget and assessment rate, the Committee considered alternatives, including raising the assessment rate to $0.03 per carton to replenish reserves. However, Committee members determined that because annual expenditures were relatively stable, it was not crucial to add to reserves at this time and the alternative was rejected. The Committee also considered maintaining the current assessment rate of $0.02 per carton. However, the Committee members did not want to make another large draw on reserves to meet 2024-2025 expenses after doing so in previous seasons. Consequently, this alternative was rejected.

A review of historical and preliminary information pertaining to the 2024-2025 fiscal period indicates the average grower price should be approximately $7.43 4/5 -bushel carton of citrus or equivalent. Therefore, the estimated assessment revenue for the 2024-2025 fiscal period as a percentage of total grower revenue would be about 0.34 percent ($0.025 divided by $7.43 multiplied by 100).

This proposed rule would increase the assessment obligation imposed on handlers. Assessments are applied uniformly on all handlers, and some of the costs may be passed on to producers. However, these costs are expected to be offset by the benefits derived by the operations of the Order.

The Committee's meetings are widely publicized throughout the Florida citrus industry and all interested persons are invited to attend the meeting and participate in Committee deliberations on all issues. Like all Committee meetings, the September 23, 2024, and November 14, 2024, meetings were public meetings and all entities, both large and small, were able to express views on this issue. Finally, interested persons are invited to submit comments on this proposed rule, including the regulatory impacts of this action on small businesses.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), the Order's information collection requirements have been previously approved by OMB and assigned OMB No. 0581-0189 Fruit Crops. No changes to those requirements would be necessary based on this proposed rule. Should any changes become necessary, they would be submitted to OMB for approval.

This proposed rule would not impose any additional reporting or recordkeeping requirements on either small or large Florida citrus handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies.

AMS is committed to complying with the E-Government Act to promote 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.

AMS has not identified any relevant Federal rules that duplicate, overlap, or conflict with this proposed rule.

A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at: https://www.ams.usda.gov/rules-regulations/moa/small-businesses. Any questions about the compliance guide should be sent to Antoinette Carter at the previously mentioned address in the FOR FURTHER INFORMATION CONTACT section.

After consideration of all relevant material presented, including the information and recommendations submitted by the Committee and other available information, AMS has determined that this proposed rule is consistent with and would effectuate the purposes of the Act.

A 30-day comment period is provided to allow interested persons to comment on this proposed rule. All written comments timely received will be considered before a final determination is made on this rule.

For the reasons set forth in the preamble, the Agricultural Marketing Service proposes to amend 7 CFR part 905 as follows:

This action, pursuant to 5 U.S.C. 553, proposes to amend regulations issued to carry out a marketing order as defined in 7 CFR 900.2(j). This proposed rule is issued under Marketing Order No. 925, as amended (7 CFR part 925), regulating the handling of grapes grown in a designated area of southeastern California. Part 925 (referred to as the “Order”) is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.” The Committee locally administers the Order and is comprised of producers and handlers of grapes operating within the area of production, and a public member.

The Agricultural Marketing Service (AMS) is issuing this proposed rule in conformance with Executive Orders 12866, as amended by Executive Order 13563. Executive Orders 12866 and 13563 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. This proposed action falls within a category of regulatory actions that the Office of Management and Budget (OMB) exempted from Executive Order 12866 review.

This proposed rule has been reviewed under Executive Order 13175, “Consultation and Coordination with Indian Tribal Governments,” which requires Federal agencies to consider whether their rulemaking actions would have Tribal implications. AMS has determined that this proposed rule is unlikely to 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.

This proposed rule has been reviewed under Executive Order 12988, “Civil Justice Reform.” Under the Order now in effect, California grape handlers are subject to assessments. Funds to administer the Order are derived from such assessments. It is intended that the assessment rate would be applicable to all assessable grapes for the 2025 fiscal period, and continue until amended, suspended, or terminated.

The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order, is not in accordance with law and request a modification of the order or to be exempted therefrom. Such handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.

This proposed rule would decrease the assessment rate for California grapes handled under the Order from $0.040 to $0.030 per 18-pound lug for the 2025 and subsequent fiscal periods.

Sections 925.40, and 925.41 of the Order authorize the Committee, with the approval of AMS, to formulate an annual budget of expenses and collect assessments from handlers to administer the program. The members of the Committee are familiar with the Committee's needs and with the costs of goods and services in their local area and can formulate an appropriate budget and assessment rate. The assessment rate is formulated and discussed in a public meeting, and all directly affected persons have an opportunity to participate and provide input.

For the 2021 and subsequent fiscal periods, the Committee recommended, and AMS approved, an assessment rate of $0.040 per 18-pound lug of California grapes within the production area. That rate continues in effect from fiscal period to fiscal period until modified, suspended, or terminated by AMS upon recommendation and information submitted by the Committee or other information available to AMS.

The Committee met on November 12, 2024, and unanimously recommended 2025 fiscal period expenditures of $88,600 and an assessment rate of $0.030 per 18-pound lug of California grapes handled for the 2025 and subsequent fiscal periods. In comparison, last fiscal period's budgeted expenditures were $77,000. The proposed assessment rate of $0.030 per 18-pound lug is $0.010 lower than the rate currently in effect. The Committee recommended decreasing the assessment rate to draw down its reserve funds to within a level authorized under the Order. The Committee projects 2,000,000 18-pound lugs of assessable California grapes for the 2025 fiscal period, the same amount that the Committee initially projected for the 2024 fiscal period.

The major category of budgeted expenditures recommended by the Committee for the 2025 fiscal period include management and administrative services, office expenses, and a financial audit, consistent with budgeted expenditures for the 2024 fiscal period.

The Committee derived the recommended assessment rate by reviewing anticipated expenses, the estimated volume of assessable grapes, and the amount of funds available in the authorized reserve. The estimated 2,000,000 18-pound lugs of assessable California grapes would generate $60,000 in assessment revenue at the proposed rate (2,000,000 18-pound lugs multiplied by the $0.030 assessment rate). The income generated from handler assessments, along with approximately $28,600 in reserve funds, would be sufficient to meet the Committee's estimated program expenditures of $88,600. Funds available in the financial reserve (currently about $110,000) would be kept within the maximum permitted by the Order (not to exceed approximately one fiscal period's expenses, as authorized in § 925.42).

The proposed assessment rate would continue in effect indefinitely unless modified, suspended, or terminated by AMS upon recommendation and information submitted by the Committee or other available information. Although this assessment rate would be in effect for an indefinite period, the Committee will continue to meet prior to or during each fiscal period to recommend a budget of expenses and consider recommendations for modification of the assessment rate. The dates and times of Committee meetings are available from the Committee or AMS. Committee meetings are open to the public and interested persons may express their views at these meetings. AMS will evaluate Committee recommendations and other available information to determine whether modification of the assessment rate is needed. Further rulemaking would be undertaken as necessary. The Committee's 2025 fiscal period budget, and those for subsequent fiscal periods, will be reviewed and as appropriate, approved by AMS.

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

The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and the rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf.

There are approximately six handlers of California grapes subject to regulation under the Order and approximately six producers (separate from handlers) of California grapes in the production area. At the time this analysis was prepared, the Small Business Administration (SBA) defined small agricultural service firms as those having annual receipts equal to or less than $34,000,000 (North American Industry Classification System (NAICS) code 115114, Postharvest Crop Activities), and small agricultural producers of grapes are defined as those having annual receipts equal to or less than $4,000,000 (NAICS code 111332, Grape Vineyards) (13 CFR 121.201).

USDA's National Agricultural Statistics Service (NASS) reported a 2023 season average California grape producer price of $1,850 per ton, equivalent to $16.65 per 18-pound container ([$1,850 per ton divided by 2,000 pounds] multiplied by 18 equals $16.65). The Committee reported a 2023 grape shipment quantity of 2,549,484 18-pound lugs. Multiplying 2,549,484 by the $16.65 average producer price yields an estimated annual crop value per producer of $7.075 million. Assuming a normal distribution, the majority of California grape producers subject to the order have estimated annual receipts of well over $4,000,000 and may be classified as large entities according to the SBA definition (NAICS code 111332, Grape Vineyards).

In addition, USDA Market News reported an average terminal market price of $38.53 per 18-pound container for the 2024 calendar year (annual average of the weekly low-high price range midpoint, 18-pound container bagged, California origin, various varieties, non-organic, all U.S. terminal markets, all grades and sizes). With approximately 2,549,484 18-pound lugs handled, the total value would be $98,221,221 (2,549,484 multiplied by $38.53). With six grape handlers within the production area, the 2024 average revenue per handler is estimated to be $16,370,203 ($98,221,221 divided by 6), which is below the $34 million SBA size threshold (NAICS code 115114, Postharvest Crop Activities) for handlers. Thus, most of the six California grape handlers subject to the order may be classified as small entities.

This proposed rule would decrease the assessment rate collected from handlers for the 2025 and subsequent fiscal periods from $0.040 to $0.030 per 18-pound lug of assessable California grapes ($0.010 lower, or 25% decrease). The Committee unanimously recommended 2025 fiscal period expenditures of $88,600 and an assessment rate of $0.030 per 18-pound lug of California grapes. The Committee expects the industry to handle 2,000,000 18-pound lugs of assessable California grapes during the 2025 fiscal period. Thus, the $0.030 per 18-pound lug rate should provide roughly $60,000 in assessment income (2,000,000 18-pound lugs multiplied by $0.030 per 18-pound lug). Income derived from handler assessments along with reserve funds should be sufficient to meet budgeted expenditures for the 2025 fiscal period.

The major category of budgeted expenditures recommended by the Committee for the 2025 fiscal period include management and administrative services, office expenses, and a financial audit, consistent with budgeted expenditures for the 2024 fiscal period.

The Committee recommended decreasing the assessment rate to utilize funds from its reserve to meet necessary expenses for the 2025 fiscal period, and ensure the reserve is maintained at a level in compliance with order requirements.

Prior to arriving at this budget and assessment rate recommendation, the Committee discussed various alternatives, including reducing the assessment rate more and/or less than the rate proposed herein. However, the Committee determined that the recommended assessment rate would achieve its goals of both adequately funding Committee operations and reducing the reserve to an appropriate level. Consequently, those alternatives were rejected.

A review of historical and preliminary information pertaining to the 2025 fiscal period indicates the average producer price for the 2025 fiscal period should be approximately $13.11 per 18-pound lug of California grapes. Therefore, the estimated assessment revenue for the 2025 fiscal period as a percentage of total producer revenue would be about 0.23 percent ($0.030 per 18-pound lug assessment rate divided by $13.11 and multiplied by 100).

This proposed action would decrease the assessment obligation imposed on handlers. Assessments are applied uniformly on all handlers, and some of the costs may be passed on to producers. However, these costs are expected to be offset by the benefits derived by the operation of the Order.

The Committee's meetings are widely publicized throughout the California grape industry and all interested persons are invited to attend the meetings and participate in Committee deliberations on all issues. Like all Committee meetings, the November 12, 2024, meeting was a public meeting and all entities, both large and small, were able to express views on this issue. Finally, interested persons are invited to submit comments on this proposed rule, including the regulatory and information collection impacts of this action on small businesses.

In accordance with the Paperwork Reduction Act of 1995, (44 U.S.C. chapter 35), the Order's information collection requirements have been previously approved by OMB and assigned OMB No. 0581-0189, Fruit and Specialty Crops. No changes in those requirements would be necessary as a result of this proposed rule. Should any changes become necessary, they would be submitted to OMB for approval.

This proposed rule would not impose any additional reporting or recordkeeping requirements on either small or large California grape handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies.

AMS is committed to complying with the E-Government Act, to promote 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.

AMS has not identified any relevant Federal rules that duplicate, overlap, or conflict with this proposed rule.

A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at: https://www.ams.usda.gov/rules-regulations/moa/small-businesses. Any questions about the compliance guide should be sent to Antoinette Carter at the previously mentioned address in the FOR FURTHER INFORMATION CONTACT section.

After consideration of all relevant material presented, including the information and recommendations submitted by the Committee and other available information, AMS has determined that this proposed rule is consistent with and would effectuate the purposes of the Act.

A 30-day comment period is provided to allow interested persons to respond to this proposed rule. All written comments timely received will be considered before a final determination is made on this proposed rule.

For the reasons set forth in the preamble, the Agricultural Marketing Service proposes to amend 7 CFR part 925 as follows:

This action, pursuant to 5 U.S.C. 553, proposes to amend regulations issued to carry out a marketing order as defined in 7 CFR 900.2(j). This proposed rule is issued under Marketing Agreement and Order No. 956, both as amended (7 CFR part 956), regulating the handling of sweet onions grown in the Walla Walla Valley of Southeast Washington and Northeast Oregon. Part 956 (referred to as the “Order”) is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.” The Committee locally administers the Order and is comprised of producers and handlers of Walla Walla sweet onions operating within the area of production, as well as a public member.

The Agricultural Marketing Service (AMS) is issuing this proposed rule in conformance with Executive Order 12866, as amended by Executive Order 13563. Executive Orders 12866 and 13563 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. This action falls within a category of regulatory actions that the Office of Management and Budget (OMB) exempted from Executive Order 12866 review.

This proposed rule has been reviewed under Executive Order 13175, “Consultation and Coordination with Indian Tribal Governments,” which requires Federal agencies to consider whether their rulemaking actions would have Tribal implications. AMS has determined that this rulemaking is unlikely to 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.

This proposed rule has been reviewed under Executive Order 12988, “Civil Justice Reform.” Under the Order now in effect, Walla Walla sweet onion handlers are subject to assessments. Funds to administer the Order are derived from such assessments. It is intended that the assessment rate would be applicable to all assessable Walla Walla sweet onions for the 2025 fiscal period, and continue until amended, suspended, or terminated.

The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608(c)(15)(A) of the Act, any handler subject to an order may file with U.S. Department of Agriculture (USDA) a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. Such handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.

This proposed rule would decrease the assessment rate for Walla Walla sweet onions handled under the Order from $0.20 per 50-pound bag or equivalent, the rate that was established for the 2023 and subsequent fiscal periods, to $0.17 per 50-pound bag or equivalent for the 2025 and subsequent fiscal periods.

Sections 956.41 and 956.42 of the Order authorize the Committee, with the approval of AMS, to formulate an annual budget of expenses and collect assessments from handlers to administer the program. The members of the Committee are familiar with the Committee's needs and with the costs of goods and services in their local area and are able to formulate an appropriate budget and assessment rate. The assessment rate is formulated and discussed in a public meeting, and all directly affected persons have an opportunity to participate and provide input.

For the 2023 and subsequent fiscal periods, the Committee recommended, and AMS approved, an assessment rate of $0.20 per 50-pound bag or equivalent of Walla Walla sweet onions. That rate continues in effect from fiscal period to fiscal period until modified, suspended, or terminated by AMS upon recommendation and information submitted by the Committee or other information available to AMS.

The Committee met on December 4, 2024, and unanimously recommended with a vote of six in favor and none opposed, 2025 fiscal period expenditures of $58,374 and an assessment rate of $0.17 per 50-pound bag or equivalent of Walla Walla sweet onions handled for the 2025 and subsequent fiscal periods. In comparison, last year's budgeted expenditures were $56,330. The proposed assessment rate of $0.17 per 50-pound bag or equivalent is $0.03 lower than the rate currently in effect. The Committee recommended decreasing the assessment rate to reduce its reserve funds to within a level authorized under the Order. The Committee projects 222,950 50-pound bags or equivalent of assessable Walla Walla sweet onions for the 2025 fiscal period, which is 20,800 50-pound bags or equivalent less than was projected for the 2024 fiscal period.

The major expenditures recommended by the Committee for the 2025 fiscal period include administrative, promotion, research, and travel expenses as well as a contingency emergency fund. This is consistent with budgeted expenditures for the 2024 fiscal period except there was no budgeted contingency fund.

The Committee derived the recommended assessment rate by considering anticipated crop year expenses, expected volume of assessable Walla Walla sweet onions, and the amount of funds available in the authorized reserve. The expected 222,950 50-pound bags or equivalent of Walla Walla sweet onions from the 2025 crop is expected to generate $37,902 in assessment revenue at the proposed assessment rate (222,950 50-pound bags or equivalent multiplied by the $0.17 assessment rate). The income generated from handler assessments, along with $20,472 in reserve funds, would be sufficient to meet the Committee's estimated program expenditures of $58,374 for the 2025 fiscal period. Funds available in the financial reserve (projected to be about $91,694 at the start of the 2025 fiscal period) would be kept within the maximum permitted by the Order (not to exceed two fiscal period's budgeted expenses, as authorized in § 956.44).

The proposed assessment rate would continue in effect indefinitely unless modified, suspended, or terminated by AMS upon recommendation and information submitted by the Committee or other available information. Although this assessment rate would be in effect for an indefinite period, the Committee would continue to meet prior to or during each fiscal period to recommend a budget of expenses and consider recommendations for modification of the assessment rate. The dates and times of Committee meetings are available from the Committee or AMS. Committee meetings are open to the public and interested persons may express their views at these meetings. AMS would evaluate Committee recommendations and other available information to determine whether modification of the assessment rate is needed. Further rulemaking would be undertaken as necessary. The Committee's 2025 fiscal period budget, and those for subsequent fiscal periods, will be reviewed and, as appropriate, approved by AMS.

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

The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and the rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf.

There are approximately 12 producers of Walla Walla sweet onions in the production area and 8 handlers subject to regulation under the Order. Small agricultural producers of Walla Walla sweet onions are defined by the Small Business Administration (SBA) as those having annual receipts of less than $3,750,000 (North American Industry Classification System (NAICS) code 111219, Other Vegetable (except Potato) and Melon Farming) and small agricultural service firms are defined as those whose annual receipts are less than $34,000,000 (NAICS code 115114, Postharvest Crop Activities) (13 CFR 121.201).

According to the USDA National Agricultural Statistics Service (NASS), the average annual producer price received for dry onions sold in Washington between 2020 and 2023 ranged from $9.13 to $26.20 per hundredweight. The average over those years was approximately $17.98 per hundredweight, or $8.99 per 50-pound bag or equivalent. Total production of Walla Walla sweet onions for the 2024 season was reported by the Committee to be 283,136 50-pound bags or equivalent. Using the average price from 2020-2023, the most recent years for which there is NASS data, the total 2024 crop value of Walla Walla sweet onions could therefore be estimated to be $2,545,393 (283,136 50-pound bags or equivalent multiplied by $8.99 per 50-pound equivalent). Dividing the estimated crop value by the estimated number of producers (12) yields an estimated average receipt per producer of $212,116 ($2,545,393 divided by 12), which is well below the SBA small agricultural producer threshold of $3,750,000 in annual receipts.

According to USDA Market News data, the terminal market price for Walla Walla sweet onions in the most recent season for which data is available (2021) was $34.96 per 40-pound carton. Multiplying this figure by 1.25 to adjust for a 50-pound bag or equivalent yields an average 2021 terminal market price of $43.70 per 50-pound bag or equivalent. Multiplying the 2024 Walla Walla sweet onion production of 283,136 50-pound bags or equivalent by the estimated average price per 50-pound bag or equivalent of $43.70 equals $12,373,043 ($34.96 times 1.25 times 283,136). Dividing this figure by the 8 regulated handlers yields estimated average annual handler receipts of $1,546,630 ($12,373,043 divided by 8 handlers), which is below the SBA threshold for small agricultural service firms of $34,000,000 in annual receipts. Therefore, using the above data, all of the producers and handlers of Walla Walla sweet onions would likely be classified as small entities according to the SBA definition.

This proposal would decrease the assessment rate collected from handlers for the 2025 and subsequent fiscal periods from $0.20 to $0.17 per 50-pound bag or equivalent of Walla Walla sweet onions. The Committee unanimously recommended 2025 fiscal period expenditures of $58,374 and an assessment rate of $0.17 per 50-pound bag or equivalent of Walla Walla sweet onions. The proposed assessment rate of $0.17 is $.03 lower than the current rate. The Committee expects the industry to handle 222,950 50-pound bags or equivalent of Walla Walla sweet onions during the 2025 fiscal period. Thus, the $0.17 per 50-pound bag or equivalent rate should provide $37,902 in assessment income (222,950 50-pound bags or equivalent multiplied by $0.17). The Committee also expects to use $20,472 from its financial reserve to cover remaining expenses. Income derived from handler assessments, along with reserve funds, should be adequate to meet budgeted expenditures for the 2025 fiscal period.

The major expenditures recommended by the Committee for the 2025 fiscal period include administrative, promotion, research, and travel expenses, as well as a contingency emergency fund. This is consistent with expenditures for the 2024 fiscal period except there was no budgeted contingency fund.

In recent years, the Committee has added to its reserve funds by collecting assessment revenue in excess of budgeted expenditures. The Committee recommended decreasing the assessment rate to refrain from holding excessive funds in its reserve. The Committee will still adequately fund 2025 budgeted expenses from assessment revenue and utilizing funds from its reserve. This action is expected to lower and maintain the Committee's reserve balance at a level that the Committee believes is appropriate and is compliant with the provisions of the Order.

Prior to arriving at this budget and the assessment rate recommendation, the Committee discussed various alternatives, including maintaining the current assessment rate of $0.20 per 50-pound bag or equivalent as well as decreasing the assessment rate by different amounts. However, the Committee determined that the recommended assessment rate would be able to fund most of its budgeted expenses, with the balance coming from its financial reserve, and avoid increasing reserves to an inappropriate level. The assessment rate of $0.17 per 50-pound bag or equivalent of Walla Walla sweet onions was derived by considering anticipated expenses, the projected volume of assessable Walla Walla sweet onions, the projected monetary balance held in reserve, and additional pertinent factors.

A review of NASS information indicates that the average producer price for the 2020-2023 crop years was $8.99 per 50-pound bag or equivalent. Further, the Committee reported the quantity of assessable Walla Walla sweet onions harvested in the 2024 fiscal period was 283,136 50-pound bags or equivalent, which yields estimated total producer revenue for 2024 of approximately $2,545,392 ($8.99 per 50-pound bag or equivalent multiplied by 283,136). Therefore, utilizing the assessment rate of $0.17 per 50-pound bag or equivalent, assessment revenue for the 2024 fiscal period, as a percentage of total producer revenue, would be approximately 1.89 percent ($0.17 multiplied by 283,136 per 50-pound bags or equivalent divided by $2,545,392 and multiplied by 100).

This proposed action would decrease the assessment obligation imposed on handlers. Assessments are applied uniformly on all handlers, and some of the costs may be passed on to producers. However, these costs would be offset by the benefits derived by the operation of the Order.

The Committee's meetings are widely publicized throughout the production area. The Walla Walla sweet onion industry and all interested persons are invited to attend the meetings and participate in Committee deliberations on all issues. Like all Committee meetings, the December 4, 2024, meeting was a public meeting and all entities, both large and small, were able to express views on this issue. Finally, interested persons are invited to submit comments on this proposed rule, including the regulatory and information collection impacts of this action on small businesses.

In accordance with the Paperwork Reduction Act of 1995, (44 U.S.C. chapter 35), the Order's information collection requirements have been previously approved by OMB and assigned OMB No. 0581-0178, Vegetable and Specialty Crops. No changes in those requirements would be necessary as a result of this proposed rule. Should any changes become necessary, they would be submitted to OMB for approval.

This proposed rule would not impose any additional reporting or recordkeeping requirements on either small or large Walla Walla sweet onion handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies.

AMS is committed to complying with the E-Government Act, to promote 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.

AMS has not identified any relevant Federal rules that duplicate, overlap, or conflict with this proposed rule.

A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at: https://www.ams.usda.gov/rules-regulations/moa/small-businesses. Any questions about the compliance guide should be sent to Antoinette Carter at the previously mentioned address in the FOR FURTHER INFORMATION CONTACT section.

After consideration of all relevant material presented, including the information and recommendations submitted by the Committee and other available information, AMS has determined that this proposed rule is consistent with and would effectuate the purposes of the Act.

A 30-day comment period is provided to allow interested persons to respond to this proposed rule. All written comments timely received will be considered before a final determination is made on this rulemaking.

For the reasons set forth in the preamble, AMS proposed to amend 7 CFR part 956 as follows:

This action, pursuant to 5 U.S.C. 553, proposes to amend regulations issued to carry out a marketing order as defined in 7 CFR 900.2(j). This proposed rule is issued under Marketing Order No. 984, as amended (7 CFR part 984), regulating the handling of walnuts grown in California. Part 984 (referred to as the Order) is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.” The Board locally administers the Order and is comprised of growers and handlers of California walnuts operating within the area of production, and a public member.

The Agricultural Marketing Service (AMS) is issuing this proposed rule in conformance with Executive Orders 12866, as amended by Executive Order 13563. Executive Orders 12866 and 13563 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. This action falls within a category of regulatory actions that the Office of Management and Budget (OMB) exempted from Executive Order 12866 review.

This proposed rule has been reviewed under Executive Order 13175, “Consultation and Coordination with Indian Tribal Governments,” which requires Federal agencies to consider whether their rulemaking actions would have Tribal implications. AMS has determined that this proposed rule is unlikely to 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.

This action has been reviewed under Executive Order 12988, “Civil Justice Reform.” This proposed rule is not intended to have retroactive effect.

The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 8c(15)(A) of the Act (7 U.S.C. 608c(15)(A)), any handler subject to an order may file with the USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. Such handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.

This proposed rule would provide a defined payment schedule for required handler assessment payments. Additionally, the proposal would establish interest and late payment charges on overdue handler assessments owed under the Order. Lastly, the proposed action would modify the reporting requirements for walnut acquisitions. These proposed changes were unanimously approved, in two separate votes, with eight in favor and none opposed, during Board meetings held on August 8, and November 6, 2024.

Section 984.69(a) of the Order provides that each handler shall pay the Board, on demand, his or her pro rata share of the Boards authorized expenses. Currently, each handler's assessment obligation is invoiced throughout the marketing year based upon the quantity of walnuts the handler has acquired and reported to the Board by January 15 of each year on the Order's CWB Form #1. However, the schedule of when assessments are invoiced, and payments are due, is not yet specified in the Order's regulations.

Further, § 984.69(c) of the Order provides the authority to establish late payment charges and interest charges on assessments that are not paid within the time period specified by the Board. While such late payment penalties are authorized under the Order, specific late payment charges and interest rate charges on past due assessments have not yet been established in the Order's regulations.

Additionally, § 984.73 of the Order provides the authority to require handlers to submit reports of their walnut receipts. Under that authority, § 984.473, “Report of walnut receipts,” was established to require handlers to report walnut acquisitions, on or before January 15 of each marketing year, on forms supplied by the Board. Currently, under that section of the Order, handlers are only required to submit one report each marketing year, with no provision providing instruction for reporting walnuts that may be acquired after January 15.

This proposed rule would modify the Order's current administrative requirements to enhance the efficient collection of assessments from handlers, strengthening the Board's oversight of the program operations and administration of the Order. The Board believes that the changes and additions proposed herein would serve to augment the Order's administrative requirements and incentivize compliance.

Specifically, this proposed rule would add a new § 984.348, “Payment of assessments,” to the Order's requirements to establish the payment schedule for handler assessments. Each handler would pay assessments, based on the quantity of walnut receipts reported by the handler pursuant to § 984.473, in three equal installments invoiced by the Board, on January 31, April 30, and July 31 of each marketing year. This specific payment schedule, as proposed, is based on industry practice. Based on Board discussions, establishing this proposed schedule in the Order itself would help to stabilize and smooth revenue streams. Such stability would help the Board's operability by reducing uncertainty about when assessments are due and provide handlers with clear expectations and timeframe. This proposed schedule is not clear in the Order or provided for in its administrative regulations.

In addition, through the authority provided by § 984.69(c) of the Order, this proposed rule would also establish late payment penalties and interest charges for handler assessment payments under a new § 984.349, “Late payment and interest charges.” This, in conjunction with the establishment of the payment schedule, would help the Board address the issue of handler confusion with late payment submissions. A late payment charge of ten percent (10%) would be imposed on any assessment payment that has not been received within sixty (60) days of the invoice date on the handler's assessment statement. Further, assessment payments not received within sixty (60) days after the invoice date would also be subject to an ongoing one and one-half percent (1.5%) per month interest charge, accruing monthly until the total balance due, including any late payment charge, is paid. The inclusion of a late payment penalty and interest charges provision as proposed would establish a clear calculation for the Board to apply to a handler's account when in arrears. This proposal would also provide an incentive for handlers to comply with the proposed payment installment schedule.

Finally, this proposed action would modify the reporting requirements in § 984.473, “Report of walnut receipts” which requires handlers to report walnut acquisitions on or before January 15 of each marketing year on forms supplied by the Board. This proposed rule would add provisions for reporting walnuts that are acquired after the January 15 reporting deadline. Although the occurrence of walnuts arriving to handlers after January 15 is not common, when it does occur, it creates confusion concerning how the reporting requirements and assessment collections are applied to those late arriving walnuts. As such, the Board proposed a simple solution: each handler acquiring walnuts from growers after submission of his or her initial report of walnut receipts would also be required to file a revised report of walnut receipts by the 15th of the month following such receipt. Handlers must pay assessments on such receipts upon demand, as requested by the Board, following receipt of the revised report.

The proposed changes collectively aim to reinforce the integrity of the walnut marketing order, promote compliance, and reduce reliance on legal remedies for collection. By fostering transparency, timely reporting, and punctual payments, these measures are expected to facilitate the orderly marketing of California walnuts and enhance the continued effectiveness of the program for the benefit of industry stakeholders.

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

The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and the rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf.

There are approximately 68 handlers subject to regulation under the Order and approximately 4,500 growers of California walnuts in the production area. At the time this analysis was prepared, the Small Business Administration (SBA) defined small agricultural service firms as those having annual receipts of less than $34,000,000 (North American Industry Classification System (NAICS) code 115114, Postharvest Crop Activities), and small agricultural producers of walnuts as those having annual receipts of less than $3,750,000 (NAICS code 111335, Tree Nut Farming) (13 CFR 121.201).

Data from USDA's National Agricultural Statistics Service (NASS), indicate a three-year average value of utilized inshell walnut production of $737.1 million for the most recent seasons for which data is available (2022 through 2024 crop years). Dividing that figure by the number of walnut growers (4,500) yields an average annual crop value per grower of approximately $163,787. This figure is well below the SBA small agricultural producer threshold of $3,750,000 in annual sales. Assuming a normal distribution, this provides evidence that a large majority of walnut growers would likely be considered small agricultural producers according to the SBA definition. Additionally, data from NASS's 2022 Agricultural Census show that 96 percent of California farms growing walnuts at the time had walnut sales of less than $1 million.

Further, based on information from the Board, approximately 78 percent of California's walnut handlers shipped assessable walnuts valued under $34 million during the 2023-2024 marketing year and would, therefore, be considered small handlers according to the SBA definition. Considering the above-mentioned information, it is reasonable to conclude that a substantial majority of both walnut growers and handlers would be considered small business entities according to current SBA definitions.

This proposed rule would provide a defined payment schedule for required handler assessment payments, establish interest and late payment charges on overdue handler assessments, and modify the reporting requirements for walnut acquisitions. These changes were recommended by the Board to enhance the efficiency of the Board's administrative function. Authority for this proposed action is provided in §§ 984.69 and 984.73 of the Order.

The Board discussed alternatives to the recommendations contained in this rule, including different options for the reporting of walnut acquisitions, the timing of assessment payment installments, various late payment penalty rates, and the appropriate interest rate charged on unpaid assessments. The Board also considered making no changes and maintaining the Order's status quo. However, the Board recognized the financial and administrative inefficiencies inherent in the existing administrative provisions and believed that taking no action would have been imprudent. Further, the Board determined that the late penalty charge and the interest rate as proposed herein would serve to incentivize compliance with the Order's provisions without being excessive and difficult.

In accordance with the Paperwork Reduction Act of 1995, (44 U.S.C. chapter 35), the Order's information collection requirements have been previously approved by OMB and assigned OMB No. 0581-0178, Vegetable and Specialty Crops. This proposed rule would require changes to the Board's existing CWB Form #1. Further, this proposed action may result in additional report submissions from some handlers. However, the changes proposed are minor and the currently approved burden for the form would only be minimally increased by the proposed changes. The revised form has been submitted to OMB for approval.

This proposed rule may impose some additional reporting or recordkeeping requirements on either small or large California walnut handlers. However, the Board anticipates that the requirement to submit supplemental acquisition reports for walnuts that are acquired after the submission of the handler's initial CWB Form #1 report would only impact a small percentage of the total number of handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies.

AMS is committed to complying with the E-Government Act, to promote 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.

AMS has not identified any relevant Federal rules that duplicate, overlap, or conflict with this proposed rule.

A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at: https://www.ams.usda.gov/rules-regulations/moa/small-businesses. Any questions about the compliance guide should be sent to Antoinette Carter at the previously mentioned address in the FOR FURTHER INFORMATION CONTACT section.

After consideration of all relevant material presented, including the information and recommendations submitted by the Board and other available information, AMS has determined that this proposed rule is consistent with and would effectuate the purposes of the Act.

A 30-day comment period is provided to allow interested persons to respond to this proposed rule. All written comments timely received will be considered before a final determination is made on this rule.

For the reasons set forth in the preamble, the Agricultural Marketing Service proposes to amend 7 CFR part 984 as follows:

On September 19, 2025, Treasury published in the Federal Register the ANPRM to solicit public comment on questions relating to the implementation of the GENIUS Act. 90 FR 45159. Comments on the ANPRM were originally due on October 20, 2025.

Treasury has received a number of requests to extend the comment period to allow interested parties additional time to review and comment on the ANPRM. Treasury is therefore extending the comment period on the ANPRM by 15 days, to November 4, 2025.

The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments using a method listed under the ADDRESSES section. Include “Docket No. FAA-2025-3425; Project Identifier MCAI-2025-00190-T” at the beginning of your comments. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. The FAA will consider all comments received by the closing date and may amend this proposal because of those comments.

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

CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this NPRM contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this NPRM, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this NPRM. Submissions containing CBI should be sent to Fatin Saumik, Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; phone: 516-228-7350; email: 9-AVS-AIR-BACO-COS@faa.gov. Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.

EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2025-0046, dated February 19, 2025 (EASA AD 2025-0046) (also referred to as the MCAI), to correct an unsafe condition for all ATR—GIE Avions de Transport Régional Model ATR72 airplanes. Airplanes with an original airworthiness certificate or original export certificate of airworthiness issued after November 22, 2024, must comply with the airworthiness limitations specified as part of the approved type design and referenced on the type certificate data sheet; this proposed AD therefore does not include those airplanes in the applicability. The MCAI states that new or more restrictive airworthiness limitations have been developed.

EASA AD 2025-0046 specifies that it requires a task (limitation) already in ATR 72 Time Limitations Document, Revision 22, dated October 16, 2023, that is required by EASA AD 2024-0053 (which corresponds to FAA AD 2024-24-06, Amendment 39-22896 (89 FR 97502, December 9, 2024) (AD 2024-24-06)), and that incorporation of EASA AD 2025-0046 invalidates (terminates) prior instructions for that task. Therefore, this proposed AD would terminate the limitations required by paragraph (j) of AD 2024-24-06 for the tasks identified in the material referenced in EASA AD 2025-0046 only.

The FAA is proposing this AD to address the potential of ignition sources inside fuel tanks. The unsafe condition, if not addressed, could result in a fuel tank explosion and consequent loss of the airplane. You may examine the MCAI in the AD docket at regulations.gov under Docket No. FAA-2025-3425.

The FAA reviewed EASA AD 2025-0046, which specifies new or more restrictive airworthiness limitations for airplane structures and safe life limits. This material is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

These products have been approved by the civil aviation authority of another country and are approved for operation in the United States. Pursuant to the FAA's bilateral agreement with this State of Design Authority, that authority has notified the FAA of the unsafe condition described in the MCAI referenced above. The FAA is issuing this NPRM after determining that the unsafe condition described previously is likely to exist or develop in other products of the same type design.

This proposed AD would require revising the existing maintenance or inspection program, as applicable, to incorporate new or more restrictive airworthiness limitations, which are specified in EASA AD 2025-0046 described previously, as incorporated by reference. Any differences with EASA AD 2025-0046 are identified as exceptions in the regulatory text of this proposed AD.

This proposed AD would require revisions to certain operator maintenance documents to include new actions ( e.g., inspections) and Critical Design Configuration Control Limitations (CDCCLs). Compliance with these actions and CDCCLs is required by 14 CFR 91.403(c). For airplanes that have been previously modified, altered, or repaired in the areas addressed by this proposed AD, the operator may not be able to accomplish the actions described in the revisions. In this situation, to comply with 14 CFR 91.403(c), the operator must request approval for an alternative method of compliance (AMOC) according to paragraph (k)(1) of this proposed AD.

In the FAA's ongoing efforts to improve the efficiency of the AD process, the FAA developed a process to use some civil aviation authority (CAA) ADs as the primary source of information for compliance with requirements for corresponding FAA ADs. The FAA has been coordinating this process with manufacturers and CAAs. As a result, the FAA proposes to incorporate EASA AD 2025-0046 by reference in the FAA final rule. This proposed AD would, therefore, require compliance with EASA AD 2025-0046 through that incorporation, except for any differences identified as exceptions in the regulatory text of this proposed AD. Using common terms that are the same as the heading of a particular section in EASA AD 2025-0046 does not mean that operators need comply only with that section. For example, where the AD requirement refers to “all required actions and compliance times,” compliance with this AD requirement is not limited to the section titled “Required Action(s) and Compliance Time(s)” in EASA AD 2025-0046. Material required by EASA AD 2025-0046 for compliance will be available at regulations.gov by searching for and locating Docket No. FAA-2025-3425 after the FAA final rule is published.

The FAA's process of incorporating by reference MCAI ADs as the primary source of information for compliance with corresponding FAA ADs has been limited to certain MCAI ADs (primarily those with service bulletins as the primary source of information for accomplishing the actions required by the FAA AD). However, the FAA is now expanding the process to include MCAI ADs that require a change to airworthiness limitation documents, such as airworthiness limitation sections.

For these ADs that incorporate by reference an MCAI AD that changes airworthiness limitations, the FAA requirements are unchanged. Operators must revise the existing maintenance or inspection program, as applicable, to incorporate the information specified in the new airworthiness limitation document. The airworthiness limitations must be followed according to 14 CFR 91.403(c) and 91.409(e).

The previous format of the airworthiness limitation ADs included a paragraph that specified that no alternative actions ( e.g., inspections), intervals, or CDCCLs may be used unless the actions, intervals, and CDCCLs are approved as an AMOC in accordance with the procedures specified in the AMOC paragraph under “Additional AD Provisions.” This new format includes a “Provisions for Alternative Actions, Intervals, and CDCCLs” paragraph that does not specifically refer to AMOCs, but operators may still request an AMOC to use an alternative action, interval, or CDCCL.

The FAA estimates that this AD, if adopted as proposed, would affect 34 airplanes of U.S. registry. The FAA estimates the following costs to comply with this proposed AD:

The FAA has determined that revising the existing maintenance or inspection program takes an average of 90 work-hours per operator, although the agency recognizes that this number may vary from operator to operator. Since operators incorporate maintenance or inspection program changes for their affected fleet(s), the FAA has determined that a per-operator estimate is more accurate than a per-airplane estimate. Therefore, the agency estimates the average total cost per operator to be $7,650 (90 work-hours × $85 per work-hour).

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

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

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

For the reasons discussed above, I certify this proposed regulation:

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

(2) Would not affect intrastate aviation in Alaska, and

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

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

As part of the ongoing revision of the VASRD, VA proposes to remove the note under title 38 Code of Federal Regulations (CFR) 4.116, DC 7629, Endometriosis. This change would help VA align DC 7629 with current medical science and clinical practice and expedite the process for establishing service connection. VA last updated the Gynecological Conditions and Disorders of the Breast body system in 2018. See 83 FR 15068 (April 9, 2018). However, VA did not address DC 7629 at that time. VA added DC 7629 to the VASRD to evaluate endometriosis in 1995 with a note that stated, “Diagnosis of endometriosis must be substantiated by laparoscopy.” 60 FR 19851, 19856 (April 21, 1995). VA established this note because medical professionals consider laparoscopy, which is an invasive surgical procedure that allows a surgeon to visually inspect the pelvis, as “the gold standard” for the confirmatory diagnosis of endometriosis. See Bafort, C. et al., “Laparoscopic surgery for endometriosis,” Cochrane Database of Systematic Reviews (2020), https://doi.org/10.1002/14651858.CD011031. To date, laparoscopically confirmed endometriosis is still the medical “gold standard.” Because of the note to DC 7629, VA cannot grant service connection for endometriosis in the absence of confirmation by laparoscopy.

In recent years, there has been an increased interest in establishing non-invasive means to clinically diagnose endometriosis, such as patient interviews, physical examinations, and imaging techniques. See Agarwal, S. et al., “Clinical diagnosis of endometriosis: a call to action,” American Journal of Obstetrics and Gynecology (2019), https://doi.org/10.1016/j.ajog.2018.12.039. Nevertheless, researchers suggest that “none of [these tools] have been proven to be [a] definitive clinical tool for diagnosis of endometriosis.” Parasar, P. et al., “Endometriosis: Epidemiology, Diagnosis, and Clinical Management,” Current Obstetrics and Gynecology Reports (2017), https://doi.org/10.1007/s13669-017-0187-1. Since medical providers are unlikely to use laparoscopy as a first line diagnostic tool based on the variability of symptoms among patients, a diagnosis of endometriosis can be delayed by 8 to 12 years. Kiesel, L. & Sourouni, M., “Diagnosis of endometriosis in the 21st century,” Climacteric (2019), https://doi.org/10.1080/13697137.2019.1578743.

Due to the issues mentioned, VA contends that service connection for endometriosis should no longer be dependent upon obtaining a diagnosis via laparoscopy. Even though laparoscopy is the current standard to definitively diagnose endometriosis, medical providers can make a preliminary diagnosis using non-invasive methods. After obtaining the patient's clinical history, clinicians can physically examine the patient and perform pelvic and transvaginal ultrasounds, magnetic resonance imaging, and computed tomography scans to characterize pelvic masses. Parasar, P. et al., “Endometriosis: Epidemiology, Diagnosis, and Clinical Management,” Current Obstetrics and Gynecology Reports (2017), https://doi.org/10.1007/s13669-017-0187-1. Therefore, VA considers a preliminary diagnosis of endometriosis using these other methods as sufficiently reliable to warrant service connection for the condition and evaluation at the 10% and 30% levels in the current rating criteria.

This change would allow VA to align DC 7629 with other rated conditions where medical providers experience challenges with providing an immediate confirmed diagnosis. For example, there is currently no standard definitive test available to diagnose multiple sclerosis (DC 8018), Parkinson's disease (DC 8004 for Paralysis agitans), or chronic fatigue syndrome (DC 6354), which means a medical professional must generally rely on the patient's symptoms and medical history, and then eliminate other diseases that present similar symptoms. Because of these known challenges, VA did not include criteria within the VASRD requiring a specific test for confirming a diagnosis for these conditions. Moreover, even for purposes of confirming diagnoses in disability compensation claims, Veterans Health Administration and contract examiners cannot order surgical or other invasive procedures, such as laparoscopy. See VA's Adjudication Procedures Manual, Part X, Subpart i, Chapter 6, Section F, Topic 2, Paragraph i. As previously stated, medical providers are not likely to use laparoscopy as a first line diagnostic tool; therefore, VA does not want to impose barriers to obtaining disability compensation that do not align with established medical practices.

VA further considers this change appropriate for endometriosis since it has established procedures under 38 CFR 3.105 for addressing instances of misdiagnosis and changes in diagnosis if a preliminary diagnosis of endometriosis later changes to a different condition upon laparoscopy results or further medical evaluation.

VA bases the evaluations for endometriosis under DC 7629 on successive rating criteria derived from continuous treatment and whether symptoms are controlled by treatment. Currently, VA awards a 10% evaluation for pelvic pain or heavy or irregular bleeding requiring continuous treatment for control and a 30% evaluation for pelvic pain or heavy or irregular bleeding not controlled by treatment. VA assigns a 50% evaluation if there are (1) lesions involving the bowel or bladder confirmed by laparoscopy, (2) pelvic pain or heavy or irregular bleeding not controlled by treatment, and (3) bowel or bladder symptoms. To effectuate the change described in this rulemaking, VA proposes to remove the note for DC 7629, which states that the diagnosis of endometriosis must be substantiated by laparoscopy. This removal will have a two-fold effect: it will (1) allow VA to establish service connection for endometriosis by diagnosis without a laparoscopy (assuming the other elements of service connection are present) and (2) allow VA to assign evaluations up to 30% disabling without a laparoscopy. Please note that the criteria for the 50% evaluation will remain the same and will continue to require laparoscopy to confirm that there are lesions involving the bowel or bladder.

This amendment will ensure VA uses similar evidentiary standards across body systems when evaluating conditions having similar diagnostic challenges. By removing the note requiring laparoscopic confirmation for service connection, VA can provide benefits to veterans suffering from endometriosis faster without requiring an invasive procedure for entitlement.

VA examined the impact of this rulemaking as required by Executive Orders 12866 (September 30, 1993) and 13563 (January 18, 2011), 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. The Office of Information and Regulatory Affairs has determined that this rulemaking is not a significant regulatory action under Executive Order 12866, as supplemented by Executive Order 13563. This proposed rule is not expected to be an Executive Order 14192 regulatory action because this rule is not significant under Executive Order 12866. The regulatory impact analysis associated with this rulemaking can be found as a supporting document at www.regulations.gov.

The Secretary hereby certifies that this proposed rule would not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act (5 U.S.C. 601-612). This certification is based on the fact that small entities or businesses are not impacted by VASRD revisions. Therefore, pursuant to 5 U.S.C. 605(b), the initial and final regulatory flexibility analysis requirements of 5 U.S.C. 603 and 604 do not apply.

This proposed rule would not result in the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year.

This proposed rule contains no provisions constituting a collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).

Douglas A. Collins, Secretary of Veterans Affairs, approved this document on September 25, 2025, and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs.

For the reasons set out in the preamble, VA proposes to amend 38 CFR part 4 as set forth below:

Participation in virtual public hearing. To request a virtual public hearing, contact the public hearing team at (888) 372-8699 or by email at SPPDpublichearing@epa.gov. If requested, the hearing will be held via virtual platform on October 16, 2025. The hearing will convene at 11:00 a.m. Eastern Time (ET) and will conclude at 3:00 p.m. ET. The EPA may close a session 15 minutes after the last pre-registered speaker has testified if there are no additional speakers. The EPA will announce further details at https://www.epa.gov/stationary-sources-air-pollution/secondary-lead-smelting-national-emissions-standards-hazardous-air.

If a public hearing is requested, the EPA will begin pre-registering speakers for the hearing no later than 1 business day after a request has been received. To register to speak at the virtual hearing, please use the online registration form available at https://www.epa.gov/stationary-sources-air-pollution/secondary-lead-smelting-national-emissions-standards-hazardous-air or contact the public hearing team at (888) 372-8699 or by email at SPPDpublichearing@epa.gov. The last day to pre-register to speak at the hearing will be October 14, 2025. Prior to the hearing, the EPA will post a general agenda that will list pre-registered speakers at: https://www.epa.gov/stationary-sources-air-pollution/secondary-lead-smelting-national-emissions-standards-hazardous-air.

The EPA will make every effort to follow the schedule as closely as possible on the day of the hearing. However, please plan for the hearings to run either ahead of schedule or behind schedule.

Each commenter will have 4 minutes to provide oral testimony. The EPA also recommends submitting the text of your oral testimony as written comments to the rulemaking docket.

The EPA may ask clarifying questions during the oral presentations but will not respond to the presentations at that time. Written statements and supporting information submitted during the comment period will be considered with the same weight as oral testimony and supporting information presented at the public hearing.

Please note that any updates made to any aspect of the hearing will be posted online at https://www.epa.gov/stationary-sources-air-pollution/secondary-lead-smelting-national-emissions-standards-hazardous-air. While the EPA expects the hearing to go forward as set forth above, please monitor our website or contact the public hearing team at (888) 372-8699 or by email at SPPDpublichearing@epa.gov to determine if there are any updates. The EPA does not intend to publish a document in the Federal Register (FR) announcing updates.

If you require the services of a translator or special accommodation such as audio description, please pre-register for the hearing with the public hearing team and describe your needs by October 8, 2025. The EPA may not be able to arrange accommodations without advanced notice.

Docket. The EPA has established a docket for this action under Docket ID No. EPA-HQ-OAR-2025-0078. All documents in the docket are listed in https://www.regulations.gov/. Although listed, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the internet and will be publicly available only as PDF versions that can only be accessed on the EPA computers in the docket office reading room. Certain databases and physical items cannot be downloaded from the docket but may be requested by contacting the docket office at 202-566-1744. The docket office has up to 10 business days to respond to these requests. With the exception of such material, publicly available docket materials are available electronically at https://www.regulations.gov.

Instructions. Direct your comments to Docket ID No. EPA-HQ-OAR-2025-0078. The EPA's policy is that all comments received will be included in the public docket without change and may be made available online at https://www.regulations.gov/, including any personal information provided, unless the comment includes information claimed to be CBI or other information whose disclosure is restricted by statute. Do not submit electronically to https://www.regulations.gov/ any information that you consider to be CBI or other information whose disclosure is restricted by statute. This type of information should be submitted as discussed below.

The EPA may publish any comment received to its public docket. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission ( i.e., on the Web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.

The https://www.regulations.gov/ website allows you to submit your comment anonymously, which means the EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an email comment directly to the EPA without going through https://www.regulations.gov/, your email address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the internet. If you submit an electronic comment, the EPA recommends that you include your name and other contact information in the body of your comment and with any digital storage media you submit. If the EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, the EPA may not be able to consider your comment. Electronic files should not include special characters or any form of encryption and should be free of any defects or viruses. For additional information about the EPA's public docket, visit the EPA Docket Center homepage at https://www.epa.gov/dockets.

The EPA is soliciting comment on numerous aspects of this proposed rule. The EPA has indexed each comment solicitation with an identifier ( e.g., “Question 1, Question 2, . . .) to provide a consistent framework for effective and efficient provision of comments. Accordingly, we ask that commenters include the corresponding identifier when providing comments relevant to that comment solicitation. We ask that commenters include the identifier in either a heading, or within the text of each comment ( e.g., “In response to Question 1, . . .”) to make clear which comment solicitation is being addressed. We emphasize that we are not limiting comment to these identified areas and encourage provision of any other comments relevant to this proposal.

Submitting CBI. Do not submit information containing CBI to the EPA through https://www.regulations.gov/. Clearly mark the part or all of the information that you claim to be CBI. For CBI information on any digital storage media that you mail to the EPA, note the docket ID, mark the outside of the digital storage media as CBI, and identify electronically within the digital storage media the specific information that is claimed as CBI. In addition to one complete version of the comments that includes information claimed as CBI, you must submit a copy of the comments that does not contain the information claimed as CBI directly to the public docket through the procedures outlined in Instructions above. If you submit any digital storage media that does not contain CBI, mark the outside of the digital storage media clearly that it does not contain CBI and note the docket ID. Information not marked as CBI will be included in the public docket and the EPA's electronic public docket without prior notice. Information marked as CBI will not be disclosed except in accordance with procedures set forth in 40 Code of Federal Regulations (CFR) part 2.

Our preferred method to receive CBI is for it to be transmitted electronically using email attachments, File Transfer Protocol (FTP), or other online file sharing services ( e.g., Dropbox, OneDrive, Google Drive). Electronic submissions must be transmitted directly to the Office of Air Quality Planning and Standards (OAQPS) CBI Office at the email address oaqps_cbi@epa.gov and, as described above, should include clear CBI markings and note the docket ID. If assistance is needed with submitting large electronic files that exceed the file size limit for email attachments, and if you do not have your own file sharing service, please email oaqps_cbi@epa.gov to request a file transfer link. If sending CBI information through the postal service, please send it to the following address: U.S. EPA, Attn: OAQPS Document Control Officer, Mail Drop: C404-02, 109 T.W. Alexander Drive, P.O. Box 12055, Research Triangle Park, North Carolina 27711, Attention Docket ID No. EPA-HQ-OAR-2025-0078. The mailed CBI material should be double wrapped and clearly marked. Any CBI markings should not show through the outer envelope.

Preamble acronyms and abbreviations. Throughout this preamble the use of “we,” “us,” or “our” is intended to refer to the EPA. We use multiple acronyms and terms in this preamble. While this list may not be exhaustive, to ease the reading of this preamble and for reference purposes, the EPA defines the following terms and acronyms here:

The source category that is the subject of this proposal is Secondary Lead Smelting regulated under 40 CFR part 63, subpart X. The North American Industry Classification System (NAICS) code for the secondary lead smelting industry is 331492. This category and NAICS code are not intended to be exhaustive but rather provide a guide for readers regarding the entities that this proposed action is likely to affect. The proposed standards, if finalized, would be directly applicable to the affected sources. Federal, state, local, and Tribal government entities do not own or operate sources that would be affected by this proposed action. As defined in the Initial List of Categories of Sources Under Section 112(c)(1) of the Clean Air Act Amendments of 1990 (57 FR 31576; July 16, 1992) and Documentation for Developing the Initial Source Category List, Final Report (EPA-450/3-91-030, July 1992), the secondary lead smelting source category consists of any facility engaged in the production of purified lead from lead scrap by melting and separating lead from metal and non-metallic contaminants and by reducing lead compounds to elemental lead. The category includes processes associated with secondary lead smelting such as battery breaking, smelting in reverberatory blast, rotary and electric furnaces, refining, alloying, and casting.

In addition to being available in the docket, an electronic copy of this action is available on the internet. In accordance with 5 U.S. Code (U.S.C.) 553(b)(4), a brief summary of this rule may be found at https://www.regulations.gov, Docket ID No. EPA-HQ-OAR-2025-0078. Following signature by the EPA Administrator, the EPA will post a copy of this proposed action at https://www.epa.gov/stationary-sources-air-pollution/secondary-lead-smelting-national-emissions-standards-hazardous-air. Following publication in the Federal Register , the EPA will post the Federal Register version of the proposal and key technical documents at this same website.

A memorandum showing the rule edits that would be necessary to incorporate the changes to 40 CFR part 63, subpart X proposed in this action is available in the docket (Docket ID No. EPA-HQ-OAR-2025-0078). Following signature by the EPA Administrator, the EPA also will post a copy of this document to https://www.epa.gov/stationary-sources-air-pollution/secondary-lead-smelting-national-emissions-standards-hazardous-air.

The statutory authority for this action is provided by CAA section 112, as amended (42 U.S.C. 7412). CAA section 112 establishes a two-stage regulatory process to develop standards for emissions of HAP from stationary sources. Generally, the first stage involves establishing technology-based standards that reflect the maximum achievable control technology (MACT) or an appropriate alternative. 1 The second stage involves evaluating those standards within eight years to determine whether additional standards are needed to address any remaining risk associated with HAP emissions. 2 This second stage is commonly referred to as the “residual risk review.” In addition to the residual risk review, CAA section 112 also requires the EPA to review the standards every eight years and “revise as necessary” taking into account “developments in practices, processes, or control technologies.”  3 This review is commonly referred to as the “technology review,” and is the subject of this proposal unless otherwise indicated. The discussion that follows identifies the most relevant statutory sections and briefly explains the contours of the methodology used to implement these statutory requirements.

In the first stage of CAA section 112 standard-setting process, the EPA promulgates technology-based standards under CAA section 112(d) for categories of sources identified as emitting one or more of the HAP listed in CAA section 112(b). Sources of HAP emissions are either major sources or area sources, and CAA section 112 establishes different requirements for major source standards and area source standards. “Major sources” are those that emit or have the potential to emit 10 tons per year (tpy) or more of a single HAP or 25 tpy or more of any combination of HAP. 4 All other sources are “area sources.”  5 For major sources, CAA section 112(d)(2) provides that the technology-based NESHAP must reflect the maximum degree of emission reductions of HAP achievable (after considering cost, energy requirements, and non-air quality health and environmental impacts). These standards are commonly referred to as MACT standards. CAA section 112(d)(3) also establishes a minimum control level for MACT standards, known as the MACT “floor,” based on emission controls achieved in practice by the best performing sources. In certain instances, as provided in CAA section 112(h), the EPA may set work practice standards in lieu of numerical emission standards. The EPA also considers control options that are more stringent than the floor. 6 Standards more stringent than the floor are commonly referred to as “beyond-the-floor” standards. For area sources, CAA section 112(d)(5) allows the EPA to set standards based on generally available control technologies or management practices (GACT standards) in lieu of MACT standards. For categories of major sources and any area source categories subject to MACT standards, the second stage focuses on identifying and addressing any remaining ( i.e., “residual”) risk within eight years pursuant to CAA section 112(f) and concurrently conducting a technology review pursuant to CAA section 112(d)(6). For categories of area sources subject to GACT standards, there is no requirement to address residual risk, but, similar to the major source categories, the technology review is required every eight years. 7

CAA section 112(d)(6) requires the EPA to review standards promulgated under CAA section 112 and revise them “as necessary (taking into account developments in practices, processes, and control technologies)” no less often than every eight years. In conducting this review, which we call the “technology review,” the EPA is not required to recalculate the MACT floors that were established in earlier rulemakings. 8 The EPA may consider cost in deciding whether to revise the standards pursuant to CAA section 112(d)(6). 9

The secondary lead smelting source category is defined as any facility at which lead-bearing scrap materials (typically but not limited to lead acid batteries) are recycled by smelting into elemental lead or lead alloys. 10 The Secondary Lead Smelting NESHAP applies to major and area sources. The affected source for this subpart is any of the following sources at a secondary lead smelter: blast, reverberatory, rotary, and electric furnaces; refining kettles; agglomerating furnaces; dryers; process fugitive emissions sources; buildings containing lead bearing materials; and fugitive dust sources. 11 The secondary lead smelting process consists of (1) breaking lead-acid batteries and separating the lead-bearing materials from the other materials including plastic and acid electrolyte; (2) melting lead metal and reducing lead compounds to lead metal in the smelting furnace; and (3) refining and alloying the lead to customer specifications. secondary lead smelting releases HAP as process, process fugitive, and fugitive dust emissions. Process emissions are the exhaust gases from feed dryers and from blast, reverberatory, rotary, and electric furnaces. The HAP in process emissions are primarily composed of metals, including lead compounds with arsenic, cadmium, and other metals. The emissions may also include organic compounds that result from incomplete combustion of coke that is charged to the smelting furnaces as a fuel or fluxing agent, natural gas, and/or small amounts of plastics or other materials that get fed into the furnaces along with the lead bearing materials. Process fugitive emissions occur at various points during the smelting process (such as during charging and tapping of furnaces) and are composed primarily of metal HAP. Fugitive dust emissions result from the entrainment of HAP in ambient air due to material handling, vehicle traffic, wind erosion from storage piles, and other various activities. Fugitive dust emissions are composed of metal HAP only. 12

Secondary lead smelting accounts for more than half of all lead produced around the world and there are currently no operating primary lead smelting facilities in the United States. The United States total lead consumption has remained relatively constant from 2020 to 2024, averaging 1,500 thousand metric tons. In 2024, an estimated 1,000 thousand metric tons of secondary lead was produced, an amount equivalent to 71 percent of apparent domestic consumption. 13 Nearly all secondary lead is recovered from old scrap, mostly lead-acid batteries. Since the 2012 rulemaking, five secondary lead facilities have closed. We do not anticipate any new secondary lead smelters, as currently defined, to be built in the next few years.

The EPA originally promulgated the Secondary Lead Smelting NESHAP in 1995. 14 In 2012, the EPA promulgated amendments to the Secondary Lead Smelting NESHAP to address the results of the RTR. As amended in 2012, the NESHAP specifies that facilities must limit emissions of lead compounds (as a surrogate for all non-mercury metal HAP) to an outlet concentration of 1.0 milligrams per dry standard cubic meter (mg/dscm) (0.00043 grains per dry standard cubic foot (gr/dscf)) and limit the flow-weighted average lead concentration to 0.20 mg/dscm (0.000087 gr/dscf) or less. 15   16 For process vents at new sources, the NESHAP limits lead compound emissions to 0.20 mg/dscm (0.000087 gr/dscf) or less. 17 The Secondary Lead Smelting NESHAP also regulates total hydrocarbon (THC) as a surrogate for non-dioxin and furan organic HAP and imposes dioxins and furans (D/F) limits for reverberatory, electric, blast, and collocated blast and reverberatory furnaces. 18 The NESHAP also requires that secondary lead facilities operate any sources of fugitive lead emissions within total enclosures that are maintained under negative pressure and vented to a control device and to conduct work practices to minimize fugitive dust emissions. 19

To support this action, the EPA created a current list of secondary lead smelting facilities by updating the facility list developed to support the 2012 RTR. We referenced the National Emissions Inventory (NEI)  20 and confirmed the list with the secondary lead smelting industry association, the Association of Battery Recyclers (ABR). In November 2023, the EPA issued a CAA section 114 information request to six companies that collectively own ten of the 11 facilities in the source category. 21 These companies were selected because they were operating, a majority of the source category and represented all furnace types and configurations. The CAA section 114 information request collected comprehensive information regarding process equipment, control technologies, point and fugitive emissions, and other aspects of facility operations. Additionally, as part of the CAA section 114 information request, we requested stack testing for certain emission sources ( e.g., rotary furnaces) and six months of fenceline monitoring for arsenic and lead. Responses not claimed as CBI by respondents and the list of facilities that are part of the secondary lead smelting source category are available in the docket for this action. 22

To supplement the data and information obtained through the CAA section 114 information request, we reviewed the EPA's Reasonably Available Control Technology (RACT)/Best Available Control Technology (BACT)/Lowest Achievable Emission Rate (LAER) Clearinghouse (RBLC). The EPA established the RBLC to provide a central database of air pollution technology information (including technologies required in source-specific permits) to promote the sharing of information among permitting agencies and to aid in identifying future control technology options that might apply to numerous sources within a category or apply only on a source-by-source basis. 23 The EPA also reviewed facility operating permits issued by state regulatory agencies. We also examined regional data for the lead national ambient air quality standards (NAAQS) when evaluating fenceline monitoring for this source category. More information can be found in the Clean Air Act Section 112(d)(6) Technology Review Memorandum for Secondary Lead Smelting available in the docket for this rulemaking. 24 Finally, the EPA reviewed previous test reports obtained from a CAA section 114 information request in 2010 that were used to inform the 2012 RTR.

Our technology review primarily focuses on the identification and evaluation of developments in practices, processes, and control technologies that have occurred since the MACT standards were promulgated. Where we identify such developments, we analyze their technical feasibility, estimated costs, energy implications, and non-air environmental impacts. 25 We also consider the emission reductions associated with the potential application of each development. This analysis informs our decision whether it is “necessary” to revise the emissions standards. 26 In addition, we consider the appropriateness of applying controls to new sources versus retrofitting existing sources. For this exercise, we consider any of the following to be a “development”:  27

• Any add-on control technology or other equipment that was not identified and considered during development of the original MACT standards;

• Any improvements in add-on control technology or other equipment (that were identified and considered during development of the original MACT standards) that could result in additional emissions reduction;

• Any work practice or operational procedure that was not identified or considered during development of the original MACT standards;

• Any process change or pollution prevention alternative that could be broadly applied to the industry and that was not identified or considered during development of the original MACT standards; and

• Any significant changes in the cost (including cost effectiveness) of applying controls (including controls the EPA considered during the development of the original MACT standards).

In addition to reviewing the practices, processes, and control technologies that were considered at the time we last updated the NESHAP, we review a variety of data sources in our investigation of potential practices, processes, or controls to consider. Pursuant to the D.C. Circuit's decision in Louisiana Environmental Action Network (LEAN) v. EPA, 955 F.3d 1088 (D.C. Cir. 2020), we also review available data to determine if there are any unregulated emissions of HAP within the source category and evaluate these data for use in developing new emission standards. The LEAN decision requires the EPA to address regulatory gaps when reviewing MACT standards, such as missing standards for listed air toxics known to be emitted from a major source category.

As described in section II.E of this preamble, the EPA's technology review focused on the identification and evaluation of potential developments in practices, processes, and control technologies that have occurred since the NESHAP was last updated in 2012. In conducting the technology review, the EPA reviewed and considered several sources of information to determine whether there have been developments in practices, processes, and control technologies as discussed in sections II.C and II.D of this preamble. Pursuant to CAA section 112(d)(6), we identified wet electrostatic precipitators (WESPs) and fenceline monitoring as the most relevant potential developments in practices, processes, or control technologies for consideration in this action. We did not identify any cost-effective developments in practices, processes, or control technologies that achieve greater HAP emission reductions beyond the emission reductions the NESHAP already requires; therefore, we are not proposing any changes to the Secondary Lead Smelting NESHAP based on our technology review. Information on additional technologies reviewed can be found in the memorandum titled: Clean Air Act Section 112(d)(6) Technology Review Memorandum for Secondary Lead Smelting available in the docket for this rulemaking. 28 The EPA is soliciting comment whether we should consider any additional developments not addressed here or in the technical memorandum (Question #1).

The main emission sources at secondary lead smelting facilities are process vents. Process vents route process and process fugitive emissions to particulate matter (PM) control devices from blast, reverberatory, rotary, and electric furnaces; refining kettles; agglomerating furnaces; dryers; process fugitive emissions sources; buildings containing lead bearing materials; and fugitive dust sources. For existing sources, facilities must maintain the concentration of lead compounds in any process vent gas at or below 1.0 mg/dscm and the flow-weighted average concentration of lead compounds in vent gases from the entire secondary lead smelting facility at or below 0.20 mg/dscm. 29 Typical controls at secondary lead smelting facilities include baghouses (often combined with high-efficiency particulate air (HEPA) filters), WESPs, wet scrubbers, afterburners, and dry lime scrubbers.

In the 2012 RTR, the EPA evaluated the addition of WESPs on the outlet of baghouses as a potential control technology for metal HAP emissions. At that time, one out of the then 15 existing facilities had installed a WESP. This approach involves placing a WESP on the outlet of a baghouse for further control of metal HAP emissions and under optimal conditions, can provide an estimated control efficiency of greater than 99 percent. Current emissions limits for existing facilities reflect reductions achievable using baghouses, which typically achieve 99 percent control. Currently, three out of the now 11 existing sources have added WESPs. Collectively, these three facilities represent a quarter of the source category. In the 2012 RTR, the EPA estimated that installing WESPs would result in total capital costs to the industry of $400 million and a total annualized cost of $55 million with a cost effectiveness of about $4.0 million per ton of metal HAP emissions reduced (mainly lead compounds) in 2009 dollars.

As part of this review, now that nearly a quarter of the source category utilizes WESPs to control metal HAP emissions, we have updated our cost estimates for installing WESPs at the 8 remaining facilities that do not currently operate them. Updated estimates for installation of WESPs would result in total capital costs of $621 million and a total annualized cost of $73 million for existing sources and achieve about 3.8 tpy in lead reductions (the surrogate for metal HAP). We estimate the cost effectiveness would be approximately $19 million per ton of lead reduced (in 2024 dollars). 30 Based on the cost estimated for the existing sources and applying this estimated cost to a potential new source, the estimated costs to install WESPs are $78 million in capital costs and annualized costs of $9 million, and their installation would achieve approximately 0.5 tpy of lead reduction, with cost effectiveness of $19 million per ton of lead reduced. In the 2012 RTR, we considered $1.3 million per ton (in 2009 dollars) of lead reduced as cost-effective for existing facilities. Based on this analysis, we are not proposing an emission limit reflecting a baghouse routed to WESPs for new or existing sources due to the high cost and poor cost effectiveness. The full analysis for a baghouse routed to a WESP can be found in the memorandum titled Clean Air Act Section 112(d)(6) Technology Review Memorandum for Secondary Lead Smelting in the docket of this rulemaking. 31 The EPA is soliciting comment on the determination that a baghouse routed to a WESP is not cost-effective (Question #2).

In this technology review, we evaluated fenceline monitoring as a development in practices or procedures. Fenceline monitoring is the practice by which monitors are placed around the perimeter of a facility to measure the concentration of certain pollutants. Generally, the EPA has found fenceline monitoring can sometimes be an effective tool when fugitive or ground level releases are significant, or where we have identified considerable uncertainties in HAP emissions estimates from fugitive emission sources. When required in conjunction with root cause analysis and corrective action, fenceline monitoring can potentially reduce uncertainties associated with fugitive emissions estimation and characterization. Other considerations include the types of pollutants that are emitted, the availability of fenceline monitoring measurement methods for the key pollutants, other sources of the key pollutant near the fenceline, proximity of residences or other areas where people could be exposed to emissions at or near facility fencelines, and the other types of monitoring that are already required or are being considered. For the secondary lead smelting source category, we are not proposing fenceline monitoring requirements. For the reasons discussed below, we are not proposing that fenceline monitoring requirements are “necessary” pursuant to CAA section 112(d)(6).

In the 2012 RTR, the Agency finalized a requirement for facilities to operate sources of fugitive lead emissions within total enclosures that are maintained under negative pressure and vented to a PM control device to address fugitive metal HAP emissions that drove the unacceptable levels of risk identified by the Agency. 32 Our evaluation during this current technology review determined that the total enclosure requirements and the stack and flow weighted average lead limits promulgated in the 2012 RTR have significantly reduced ground level fugitives and allow us to accurately estimate lead emissions from the source category based on stack test data. The CAA section 114 information request for fenceline monitoring data confirmed our 2012 estimates that lead levels at the fenceline would be below the lead NAAQS 3-month rolling average limit of 0.15 micrograms per cubic meter (µg/m 3 ) for most facilities. The CAA section 114 data showed lead levels at the fenceline were well below the NAAQS for all but one facility, which is currently under a state consent agreement. This represents significant improvement from data collected for the 2012 RTR, where nine of fifteen facilities were modeled to be above the NAAQS at the fenceline pre-control. While there is no NAAQS for arsenic, the EPA compared measured arsenic concentrations to the chronic inhalation reference exposure level (REL), which is used to estimate population risk due to inhalation of arsenic. All average daily arsenic concentrations were below the chronic inhalation REL of 0.015 µg/m 3 . Additionally, we compared the fenceline monitoring results to the operating lead NAAQS monitors and found the results aligned. The community NAAQS monitors near most facilities detect fugitive and stack emissions and are as effective if not more effective than fenceline monitors. Additionally, secondary lead smelting facilities are required to have bag leak detection systems  33 and comply with differential pressure monitoring  34 requirements, which identify potential situations of excess lead emissions and assist with root cause analysis and corrective action more quickly than a fenceline monitoring program.

Finally, the EPA does not have a fenceline monitoring method that has been proposed or promulgated for metals. If the EPA were to require fenceline monitoring in a rule for metals, facilities would be unable to conduct such monitoring until a method has been promulgated. To conduct the CAA section 114 information request sampling, we relied on a common ambient monitoring method for multi-metals for the analysis. 35 36 While these methods are robust and appropriate for ambient trend applications, the EPA needs to further investigate and revise these approaches for a stationary source regulatory program to ensure improved precision and accuracy in the method. This is similar to how EPA Method 327  37 was developed from TO-15A.

The EPA is not proposing to include fenceline monitoring in this rulemaking because the process fugitives are well controlled due to the total enclosure requirements of the NESHAP, several monitoring programs are already in place, such as bag leak detection systems at secondary lead facilities and NAAQS monitors in many communities surrounding secondary lead smelters, and currently there is not a promulgated fenceline monitoring method for metals. 38 The EPA is soliciting comment on our determination not to propose fenceline monitoring for the secondary lead smelting source category (Question #3).

In this proposal, we are proposing actions to address unregulated HAP pursuant to the D.C. Circuit's decision in LEAN, various technical matters, and outstanding petition issues.

Based on a review of available information pursuant to the LEAN decision, we are proposing the following: an emission limit based on MACT for THC (as a surrogate for non-D/F organic HAP) and D/F for collocated rotary and reverberatory furnaces; to add a definition for collocated rotary and reverberatory furnaces; THC as a surrogate for carbonyl sulfide (COS) emissions; and that hydrochloric acid (HCl) and chlorine (Cl 2 ) emissions are so minimal as to be considered de minimis, and therefore the EPA is not requiring standards for those pollutants.

Additionally, we are proposing a 24-month performance test extension request will be deemed approved under certain circumstances as outlined in section III.B.3. We are also proposing to increase the averaging time for differential pressure monitors and the inclusion of an alternative monitoring option for confirming total enclosure compliance.

We are also addressing outstanding petition issues from the 2012 RTR. In response to the petitions, we are taking comment on our conclusion in the 2012 RTR that the Secondary Lead Smelting NESHAP provides an ample margin of safety to protect public health and on two additional provisions.

Finally, we are proposing to remove affirmative defense provisions and revise startup, shutdown, and malfunction (SSM), and electronic recordkeeping and reporting requirements. The results and proposed decisions, as well as the rationale for those decisions, are presented below.

As previously stated in section II.C of this preamble, while reviewing the NEI and previous rulemakings, the EPA identified HCl, Cl 2 , and COS from all furnaces and THC and D/F from rotary furnaces as currently unregulated for this source category. The EPA included stack testing for these unregulated HAP as part of the CAA section 114 information request. As required by the D.C. Circuit's decision in LEAN, we are proposing to address unregulated HAP as discussed below.

As part of the 2012 RTR, the EPA promulgated THC and D/F limits for all furnace types except rotary furnaces. The EPA stated it was not adopting numerical limits for THC and D/F emissions from rotary furnaces, pending further data gathering and analysis for this furnace type. As part of the CAA section 114 information request, the EPA required testing of the only rotary furnace in the source category. Based on this information request, the EPA received five THC and D/F test runs from the one operating rotary furnace. Upon review of the test and operational data, we determined that the rotary furnace normally operates as a batch process as opposed to a continuous process, and that the five individual test runs represent periods within a batch, and not from the same batch. Therefore, the data provided from the CAA section 114 information request do not truly represent the normal operation of the rotary furnace, which ideally would measure at least three separate batch test runs of 4 hours each (or the entire length of the complete batch cycle).

Based on the data submitted in response to the CAA section 114 information request, any proposed standards for THC and D/F from the rotary furnace alone would be determined from an incomplete batch that would not be considered representative of normal operation. When calculating variability using a limited dataset (in this case, one batch) the effect of variability can be substantial. The EPA also has previous test data from this rotary furnace from the 2012 RTR. However, since 2012 the facility has made substantial changes to their processes and added additional controls. Therefore, we determined that the previous test data are also not representative of current emissions. In addition, this rotary furnace is not a “stand-alone” furnace. That is, the emissions are controlled through multiple control devices, and the rotary furnace emissions are combined downstream with emissions from other sources at the facility, prior to entering these control devices. In order to propose proper and representative THC and D/F standards from the rotary furnace, additional THC and D/F testing would need to be conducted from the rotary furnace with at least three complete batches, from start to finish, so that any process variability is included and accounted for in the test data. 39 When we determined that the data did not include at least three separate batches, we were unable to request additional testing prior to this proposal.

However, the EPA does have sufficient data to establish standards for the combined emissions of this rotary furnace and continuously operating reverberatory furnaces, using stack measurements taken at the outlet of the control device ( i.e., the WESP stack) that control HAP emissions from these units. Therefore, instead of a stand-alone rotary furnace limit, we are proposing to set a collocated rotary and reverberatory furnace limit of 34 parts per million by volume (ppmv) of THC and 0.28 ng/dscm D/F, expressed as toxic equivalency quotient (TEQ) corrected to 7 percent oxygen ( i.e., at 7 percent O 2 ). We are also proposing for D/F testing that a minimum sample volume of 3.0 dscm be collected for each run. We calculated the proposed MACT floor-based emissions limits using the standard MACT floor development procedures, which use the 99 percent upper prediction limit (UPL) to incorporate variability demonstrated by the available test data from the stack outlet of the WESP.

While these data include portions of the batch process from the rotary furnace, we believe these limits better represent emissions from actual operations, since the testing was performed at the location where the combined emissions emit to the atmosphere after all control devices, and while the facility was also continuously (and normally) operating its reverberatory furnace and periodically (and normally) operating its rotary furnace.

We expect the one facility where the collocated rotary and reverberatory limits apply can meet the proposed THC and D/F limits without installing any new pollution control devices. We anticipate only testing, recordkeeping, and reporting costs will be incurred to comply with the proposed THC and D/F limits. The EPA is also proposing to add a new definition at 40 CFR 63.542 for “collocated rotary and reverberatory furnaces” to mean operation of a rotary furnace and a reverberatory furnace at the same location, where the vent streams of the furnaces are mixed.

In the 2012 RTR, we considered beyond-the-floor options to further reduce emissions of D/F and THC from blast furnaces but did not finalize them as they were not cost-effective and would likely lead to an increase in other pollutants ( i.e., NO X and CO 2 ). 40 When considering beyond-the-floor D/F and THC limits for collocated rotary and reverberatory furnaces, the EPA found that the facility currently uses its rotary furnace to process slag after it has been processed in the reverberatory furnace. Due to the plastics separation work practices already in place and the pre-processing of slag in the reverberatory furnace, most D/F emissions from the rotary furnace are below the detection limit, which is the lowest quantifiable value. However, we found the rotary only data set to be insufficient for setting standards and, instead, are proposing to regulate the collocated rotary and reverberatory furnace limit. However, we found this data set to be insufficient for setting standards and, instead, are proposing to regulate the collocated rotary and reverberatory furnaces. D/F limits are already in place for the reverberatory furnaces, and we are proposing to add an additional limit to include D/F from rotary furnaces. We did not identify any beyond-the-floor options that would lower the D/F limits from collocated rotary and reverberatory furnaces. For THC, the facility already has several control devices in place, including a scrubber. We did not identify any new technically feasible, cost-effective control options to obtain any additional reductions for THC. More information can be found in the memorandum: Summary of MACT Floor and Beyond-the-Floor Analysis for the Secondary Lead Smelting Source Category available in the docket of this rulemaking.

The EPA is soliciting comment on the proposed THC and D/F limits and beyond-the-floor rationale (Question #4) and definition for collocated rotary and reverberatory furnaces (Question #5). THC is a surrogate for non-D/F organic HAP, as stated in previous secondary lead rulemakings and as proposed below for COS. 41 The destruction of THC through incineration is strongly correlated with the destruction of non-D/F organic HAP compounds, and COS can also be controlled using thermal controls.

Additionally, we are soliciting comment on setting the THC and D/F standards pursuant to CAA section 112(d)(6) rather than setting the THC and D/F standards exclusively pursuant to CAA section 112(d)(2) and (3) (Question #6). Although the D.C. Circuit held in LEAN that the EPA is required to address previously unregulated HAP from major sources during a CAA section 112(d)(6) technology review, it is not entirely clear how that process functions under the statutory text. In this instance, setting the standards under CAA section 112(d)(6) would result in essentially the same standards because the performance of the only collocated rotary and reverberatory furnace would be used to establish the standards, resulting in the same values as the standards we are proposing under CAA sections 112(d)(2) and (3). The difference in the approach would be that we would not be constrained to any minimum stringency level and would, therefore, not conduct a beyond-the-floor analysis. We would not anticipate any cost or impact differences associated with setting the THC and D/F limits pursuant to CAA section 112(d)(6) as compared to CAA section 112(d)(2) and (3). The estimated costs would be for testing, recordkeeping, and reporting.

During the NEI review, the EPA identified COS as a HAP that might be emitted and is not currently regulated. The CAA section 114 information request required COS testing from four facilities to determine whether COS was emitted by the source category. Three of the four facilities emitted a measurable amount of COS with one facility below the detection limit. To address this unregulated HAP, we are proposing to use THC as a surrogate for COS. Thermal control technology used to control THC simultaneously controls COS as well. In addition, THC is easily measured, and THC testing is already required for the source category. The EPA is soliciting comment on proposing THC as a surrogate for COS (Question #7).

In the 1994 Secondary Lead NESHAP proposed rule, the EPA estimated secondary lead facilities emitted 806 tpy of HCl from 16 facilities. In response, the EPA proposed HCl and Cl 2 emission limits. 42 The EPA received several comments on that proposal indicating that the feasibility of emission controls was overstated, additional controls would be needed to achieve the proposed emission standards, and polyvinyl chloride (PVC), the primary source of HCl and Cl 2 emissions, was being phased out as a separator material in batteries. Due to that new information in these comments, the EPA did not finalize emission limits for HCl and Cl 2 at that time. 43

During the 2012 RTR, the EPA estimated HCl and Cl 2 emissions from the source category had been reduced to about 2 tpy and, therefore, did not propose any emission limits at that time. 44 While reviewing emissions inventories for this rulemaking, the EPA found that secondary lead smelting facilities were still emitting small amounts of HCl and Cl 2 . Through a CAA section 114 information request, the EPA requested testing from three facilities to confirm whether and how much HCl and Cl 2 are still emitted from the source category. The testing results, supplemented with data collected during the 2012 RTR from an additional 5 facilities, showed that the source category now emits only 1.5 tpy of HCl and 0.2 tpy of Cl 2 , in total, from 11 facilities. The EPA proposes that these very small amounts of HCl and Cl 2 emitted are too trivial to justify requiring additional controls and thus amount to de minimis levels that Congress did not intend to subject to the imposition of controls under CAA section 112.

The EPA recognizes that the D.C. Circuit has emphasized that the Agency has a “clear statutory obligation to set emission standards for each listed HAP” and must address previously unregulated pollutants known to be emitted by a source category during a technology review. 45 While the D.C. Circuit's LEAN decision focused on the broad question whether the EPA is required to address unregulated pollutants generally during a CAA section 112(d)(6) technology review. The decision did not address the narrower question whether CAA section 112 displaces the ordinary background rule that a general statutory requirement does not encompass de minimis concerns unless otherwise indicated under the circumstances.

As the Supreme Court explained in Wisconsin Department of Revenue v. William Wrigley, Jr., Co., “the venerable mexim de minimis non curat lex (`the law cares not for trifles') is part of the established background of legal principles against which all enactments are adopted, and which all enactments (absent contrary indication) are deemed to accept.”  46 The Court further explained that “whether a particular activity is a de minimis deviation from a prescribed standard must, of course, be determined with reference to the purpose of the standard.”  47 In Alabama Power Company v. Costle, a CAA case, the D.C. Circuit held that categorical exemptions from the requirements of a statute may be permissible “as an exercise of agency power, inherent in most statutory schemes, to overlook circumstances that in context may fairly be considered de minimis .”  48 This principle derives from the commonplace notion that “the law does not concern itself with trifling matters.”  49 The ability to recognize de minimis regulatory issues “is not an ability to depart from the statute, but rather a tool to be used in implementing the legislative design.”  50

The EPA does not dispute that CAA section 112(d)(1) requires the Administrator to “promulgate regulations establishing emission standards for each category or subcategory of major sources and area sources of [HAP] listed for regulation pursuant to section (c) of this section.”  51 However, statutory context makes clear that Congress did not intend the EPA to relentlessly regulate trivial amounts of HAP. For example, CAA section 112(a)(1) defines a major source as one “that emits or has the potential to emit considering controls, in the aggregate, 10 tons per year or more of any [HAP] or 25 tons per year or more of any combination of [HAP].”  52 . Sources with fewer emissions are defined as area sources, which the EPA need only regulate if the Administrator finds that they present “a threat of adverse effects to human health or the environment (by such sources individually or in the aggregate) warranting regulation under this section.”  53 And once regulated, the EPA may elect to promulgate standards for area sources “which provide for the use of generally available control technologies or management practices,” as opposed to more stringent MACT standards. 54

Moreover, additional considerations support the conclusion that Congress did not intend CAA section 112 to require regulation of de minimis emissions under the circumstances CAA section 112(e)(2) expressly authorizes the EPA to determine “priorities” for developing standards under section 112(d), including based on the quantity of emissions. 55 The EPA proposes that CAA section 112 does not include the contrary language expected for an intentional departure from the ordinary de minimis background principle and that application of that principle here is consistent with the design and objective of CAA section 112 to reduce emission of HAP that endanger public health and welfare. In doing so, the EPA is also mindful of the Supreme Court's admonition that because “[l]egislation is, after all, the art of compromise ... no statute yet known 'pursues its [stated] purpose[] at all costs.”  56

Here, the secondary lead smelting source category, currently consisting of 11 major and area source facilities, emit only 1.5 tpy of HCl and 0.2 tpy of Cl 2 . Considered in isolation, these emissions are nowhere near the 10 tpy pollutant-specific and 25 tpy aggregate thresholds that trigger major source regulation. And as further discussed, the trivial amounts of HCl and Cl 2 estimated to be emitted from this source category do not amount to a level that presents or risks an adverse effect to human health or the environment. Thus, even in light of the LEAN decision, the EPA proposes that Congress did not intend CAA section 112 to abrogate the ordinary background principle that de minimis concerns do not fall within the scope of general legislative requirements under the circumstances.

As noted above, in CAA section 112(e)(2) Congress established criteria for the EPA to consider “[i]n determining priorities for promulgating standards under subsection (d).”  57 These criteria include “the known or anticipated adverse effects of such pollutants on public health and the environment; the quantity and location of emissions or reasonably anticipated emissions of [HAP] that each category or subcategory will emit”. 58 Thus, in prioritizing the EPA's work to reduce HAP emissions, Congress intended the EPA to focus on the pollutants emitted in the highest quantities with the greatest impact. Therefore, for certain pollutants emitted in trivial quantities with low impact, such as HCl and Cl 2 for this source category, EPA finds that those emissions would be the most likely to qualify for de minimis treatment under the legislative design. However, EPA would evaluate whether de minimis treatment for those emissions would continue to be appropriate during subsequent technology reviews.

Applying those criteria here, the EPA proposes to find that both support a finding that emissions from HCl and Cl 2 from secondary lead smelting facilities qualify as de minimis. 59

First, secondary lead smelting facilities emit HCl and Cl 2 in very low quantities. With regards to HCl, the EPA estimates that the average amount emitted per facility is 0.13 tpy, and no single facility emits more than 1 tpy. For Cl 2 we estimate the average amount emitted per facility is 0.017 tpy, and no single facility emits more than 0.025 tpy. In addition to the work practices, several facilities currently have control devices in place that may capture and control HCl and Cl 2 in addition to reducing other target pollutants. Finally, the EPA does not expect HCl and Cl 2 emissions to increase over time because older batteries with PVC will continue to leave circulation and thus no longer be recycled. 60

Second, the impacts of HCl and Cl 2 from this source category are very low. Neither HCl nor Cl 2 persist in the environment for long periods of time, and they do not transform into other HAP. 61 Neither HCl nor Cl 2 can bioaccumulate; that is, they do not have the ability to build up in the food chain to levels that are harmful to human health and the environment. Neither HCl  62 nor Cl 2   63 are non-threshold carcinogens. These factors decrease the likelihood of adverse impacts from these pollutants, especially at low emission rates. Indeed, the health impacts of exposure to HCl and Cl 2 emissions here are exceedingly low. Noncancer hazard is expressed as a hazard quotient (HQ), the ratio of estimated exposure to the reference value. An HQ less than or equal to one indicates that adverse effects are not likely to occur. When the EPA last assessed the risk for this source category in 2012, the estimated maximum acute HQ for HCl was more than two orders of magnitude below one. 64 The chronic risk assessment yielded an even lower HQ. While Cl 2 is understood to be a more potent noncancer toxicant than HCl, the inappreciable emissions led to similarly low potential health impacts for Cl 2 . Taken together, these results suggest there is no discernable risk of adverse health impacts from HCl and Cl 2 in this circumstance. This is particularly true given the conservative nature of the risk assessment, which used health-protective benchmarks and worst-case-scenario meteorological data for the acute scenario, and the fact that emission levels have continued to decrease over time.

Finally, the EPA distinguishes this proposed de minimis analysis from the EPA's prior decision to reject de minimis treatment for HCl for the cement kilns source category, which the D.C. Circuit previously found to be reasonable. 65 In that source category, HCl was emitted at amounts to qualify each kiln as a major source. 66 Here, as a factual matter, that is nowhere near the case for HCl or Cl 2 for the secondary lead source category as these 11 facilities emit only 1.5 tpy of HCl and 0.2 tpy of Cl 2. Further, even if this proposal arguably represents a change in the EPA's position on de minimis treatment for HCl, allowing for de minimis treatment of certain pollutants emitted in trivial amounts is the best reading of the statute when considering Congress's intent for promulgating standards as expressed in CAA section 112(e)(2). 67 The EPA seeks comment on whether the Agency's proposed de minimis treatment here for HCl and Cl 2 for the secondary lead smelting source category could be considered a change in Agency position (Question #8).

In light of these specific facts and circumstances, the EPA proposes to find that emissions of HCl and Cl 2 from secondary lead smelting facilities are de minimis and do not require emission limits. The continuing decline in these emissions due to the phaseout of PVC in batteries, and their lack of discernable risk of adverse health impacts all counsel against regulation. However, the EPA emphasizes the highly fact-specific nature of this proposed de minimis treatment. Other pollutants, even if emitted at low levels from other source categories, may not qualify for de minimis treatment where risks of adverse health impacts are significant. The EPA seeks comment on all aspects of the Agency's proposed determination, including the Agency's statutory interpretation and factual findings (Question #9).

In addition to proposing that HCl emissions are de minimis, we are also taking comment on whether to adopt a MACT HCl limit of 0.03 lb/hr in lieu of the de minimis determination (Question #10). This HCl limit was calculated using the standard MACT floor development procedures, which use the 99 percent UPL to incorporate variability demonstrated by the available test data obtained during the 2010 and 2023 CAA section 114 information requests. We did not identify any technically feasible, cost-effective control options to obtain any additional reductions for HCl. More information on the MACT floor and beyond-the-floor analysis is available in the memorandum titled: Summary of MACT Floor and Beyond the Floor Analysis for the Secondary Lead Smelting Source Category available in the docket of this rulemaking. 68 This HCl limit would serve as a surrogate for Cl 2. As affirmed by the D.C. Circuit, the EPA may use a surrogate to regulate emissions of HAP if there is a reasonable basis to do so. 69 For example, we have used PM controls as a surrogate for HAP metals “because no cement plant intentionally controls HAP metals; metal emissions are controlled only incidentally by controls placed upon PM.”  70 Thus, the court found that “EPA's response is the correct one: `cement plants actually are controlling HAP metals[,] intentionally or not.' ”  71 Here, control technologies that reduce HCl also control Cl 2. Therefore, HCl is an appropriate surrogate for Cl 2. Additionally, in the 2011 RTR proposed rule testing indicated 98 percent of chlorine was emitted as HCl.

As part of the amendments finalized in the 2012 RTR, the EPA required all secondary lead facilities to operate sources of fugitive lead emissions within total enclosures that are always maintained under negative pressure and vented to a control device. 72 As previously explained, these sources of fugitive emissions include but are not limited to the following: smelting furnaces, smelting furnace charging areas, lead taps, slag taps, molds during tapping, battery breakers, refining kettles, casting areas, dryers, material handling areas, and areas where dust from fabric filters, sweepings or used fabric filters are processed. The facilities are also required to adopt a list of specified work practice standards to minimize fugitive emissions. To demonstrate compliance with the total enclosure requirement, facilities measure compliance using three differential pressure monitors placed on the leeward wall, windward wall, and an exterior wall that connects the leeward and windward wall. Monitors must maintain negative pressure values of at least 0.013 millimeters (mm) of mercury, which is equivalent to 0.007 inches of water. 73 The rule incorporated 40 CFR 63.10(b)(2)(vii), which requires records of 15-minute averages of data collected from continuous monitoring systems (CMS). The EPA subsequently issued a Secondary Lead Smelting NESHAP direct final rule clarifying that the data collected from the continuous pressure monitors must be used to calculate 15-minute averages that are used to demonstrate compliance, and the 15-minute averages must include at least one reading per minute. 74

Since implementing the negative pressure requirements, the EPA received requests from industry to allow for alternative monitoring procedures for demonstrating continuous negative pressure for total enclosures. ABR submitted comments  75 in response to Executive Order 13777, “Enforcing the Regulatory Reform Agenda,” available in the docket of this rulemaking. In the letter, ABR requested that the EPA revise the Secondary Lead Smelting NESHAP monitoring requirements and provide an option of demonstrating compliance through fan amperage monitors via EPA Method 204, sections 6.1 and 8.3, rather than mandating that smelters employ digital differential pressure devices. Industry states that at certain smelters, digital differential pressure devices do not provide robust and valid data for measuring compliance. The size and/or configurations of buildings, including the placement of inner walls and bulkheads, produce internally induced air currents at speeds and angles that create aspiration flows in the monitors, leading to errors in pressure measurements that do not reflect the actual pressure differential of the total enclosure. In addition to configuration issues, industry noted factors outside the control of smelters, including external temperature, sudden external barometric pressure changes, and other weather conditions, can disturb the validity of differential pressure readings and inward air flow at enclosure openings. Further, in response to the CAA section 114 information request, the EPA received several responses from facilities reporting issues with external factors such as sudden weather, water intrusion, and blockages due to pest activity that affected the accuracy of the differential pressure monitoring readings.

Some EPA regional offices have approved alternative monitoring requests submitted by industry. For example, the East Penn secondary lead smelter in Lyons, Pennsylvania, and the Johnson Controls Battery Group secondary lead smelter in Florence, South Carolina, have been approved to use fan amperage as an alternative monitoring parameter to demonstrate continuous negative pressure. 76 77

In addition to the alternative monitoring request, ABR requested that the EPA revise the monitoring requirement to include a data recovery requirement consistent with 40 CFR 60.7 for all continuous monitoring devices. This is addressed in the general provisions requirements of 40 CFR 63.10(e)(3)(vii), which is applicable to 40 CFR part 63, subpart X and is similar to 40 CFR 60.7, requiring only a summary report if the total duration of excess emissions or process or control system parameter exceedances for the reporting period is less than 1 percent of the total operating time for the reporting period and CMS downtime for the reporting period is less than 5 percent of the total operating time for the reporting period.

In response to the comments received regarding differential pressure monitoring, the EPA recognizes that, as the regulations are currently written, there may be difficulty demonstrating compliance using differential pressure monitors. The rule currently requires facilities to demonstrate compliance with the standard for differential pressure by maintaining the pressure in total enclosures such that the average pressure in any 15-minute period does not fall below the level specified in 40 CFR 63.544(c)(1). To better align with the general provisions of 40 CFR part 63 and address the ongoing issues with the use of negative pressure monitors, we are proposing to increase the differential pressure averaging period from 15 minutes to 3 hours. The data from the CMS will be reduced according to 40 CFR 63.8(g)(2) to 1-hour averages, computed from four or more data points equally spaced over each 1-hour period, except during periods when calibration, quality assurance, or maintenance activities are being performed. During these periods, a valid hourly average will consist of at least two data points with each representing a 15-minute period. The increased averaging time will help differential pressure monitors overcome environmental issues such as wind and weather impacts while not disrupting the negative pressure requirements that are essential in controlling process fugitive emissions. We are also proposing to amend the rule requirements to clarify the averaging period applies to each individual monitor and not the average of the three monitors in 40 CFR 63.548(k)(4). The EPA is soliciting comment on increasing the differential pressure monitor averaging time (Question #11).

We are also proposing that affected sources of the Secondary Lead Smelting NESHAP may demonstrate compliance with the total enclosure monitoring requirements under 40 CFR 63.544(a) by using fan amperage as an alternative to differential pressure. 78 We are proposing procedures to use fan amperage that are based on EPA Method 204, sections 6.1 and 8.3 to demonstrate compliance with total enclosure monitoring. EPA Method 204 sets forth the criteria for a permanent total enclosure. Specifically, EPA Method 204 states that the pressure differential of 0.007 inches of water (or 0.013 mm of mercury) corresponds to 200 feet per minute (fpm) of inward face velocity at natural draft openings, per EPA Method 204, section 8.3. Inward face velocity (FV) can be calculated by dividing the difference between the sum of all exhaust air streams (Q O ) and the sum of all forced makeup air (Q I ) by the total area of all natural draft openings (A N ) using the following equation: 79

Smelters must use the Manufacturers' Fan Performance Curves to determine the brake horsepower requirements necessary to achieve at least 3,600 m/hr (200 fpm) FV and calculate the minimum amperage necessary to achieve that corresponding horsepower. This minimum fan amperage will be the operating limit to ensure the negative pressure of the total enclosure is always maintained. The amperage at each exhaust and intake fan must then be monitored by a current transformer, recorded at least once per minute by a programmable logic controller or equivalent device, and averaged into a 3-hour period.

The EPA is proposing to add 40 CFR 63.548(n) which includes the procedures for using fan amperage to demonstrate compliance with total enclosure requirements and add associated records in 40 CFR 63.550(c) and the reporting requirements in 40 CFR 63.550(e). The EPA is soliciting comment on allowing monitoring of total enclosure at negative pressure through the use of fan amperage (Question #12).

In their response to the CAA section 114 information request, industry requested the EPA remove the need to submit a written request to the Administrator when applying for an extension of up to 24 calendar months to conduct the next compliance test, if lead and THC testing results are 50 percent or less of the applicable emission limit. The Secondary Lead Smelting NESHAP requires sources to conduct annual compliance tests for total lead compounds and THC. The Secondary Lead Smelting NESHAP allows facilities to submit a written request to the Administrator for an extension of up to 24 calendar months from the previous compliance test to conduct the next compliance test if an annual compliance test is below a certain level. Industry notes that it has been difficult to obtain timely approval from the EPA for a performance test extension which, in practical effect, results in a denial of the extension request and smelters having to continue to conduct annual compliance testing. Therefore, industry requested that the EPA revise the Secondary Lead Smelting NESHAP to make performance test extensions of up to 24 calendar months automatic upon written notice of the request to the Administrator.

The EPA agrees that it is reasonable to expect to get a response within a reasonable timeframe before the next compliance test. Therefore, similar to the Standards of Performance for Secondary Lead Smelters for Which Construction, Reconstruction, or Modification Commenced After December 1, 2022, 80 the EPA is proposing a provision at 40 CFR 63.543(g)(3) and (h) that the extension request will be deemed approved under the following circumstances: (1) a facility completes a performance test that is measured as 50 percent or lower than the applicable emissions limit, (2) a facility submits a request for the extension within 4 months after the compliance test, and (3) the Administrator does not provide a response within 6 months of receipt of the request. The EPA is soliciting comment on the automatic approval of the 24-month testing extensions under certain circumstances (Question #13).

In January 2012, the EPA finalized the Secondary Lead Smelting RTR. In March 2012, the EPA received petitions for reconsideration from California Communities Against Toxics, Frisco Unleaded, Missouri Coalition for the Environment Foundation, NRDC, and Sierra Club (collectively); ABR; and Johnson Controls Battery Group Inc. (JCI). The EPA granted reconsideration to California Communities Against Toxics, Frisco Unleaded, Missouri Coalition for the Environment Foundation, NRDC, and Sierra Club (collectively) on the ample margin of safety analysis. The EPA also granted ABR and JCI's petitions for reconsideration.

The EPA addressed some industry issues in the subsequent Secondary Lead Smelting NESHAP direct final rule. 81 The remaining industry issues were litigated and on May 28, 2013, the court rejected the industry petitioners' arguments and denied their petitions for review. 82 Based on this court decision, we consider all the industry petitioners' reconsideration requests to be resolved, as those issues were addressed by the 2014 direct final rule or the court. The EPA will not respond to comments addressing any other issues or any other provisions of the 2012 rule not specifically addressed in this proposed rulemaking.

In their 2012 petition, Sierra Club, California Communities Against Toxics, Frisco Unleaded, Missouri Coalition for the Environment Foundation, and Natural Resources Defense Council  83 alleged that the EPA failed to adequately support its finding that the rule provided an ample margin of safety to protect public health. The ample margin of safety analysis included arsenic, cadmium, lead, dioxins and furans, organic HAP, and mercury. In 2012, the EPA granted reconsideration of the 2012 RTR on the following issue: petitioners' allegation that the EPA's ample margin analysis considered only cost, emission reductions, and cost effectiveness and did not include consideration of health and other metrics.

In evaluating and developing standards under section 112(f)(2), as discussed in Section I.A of the 2011 proposal preamble, we apply a two-step process to address residual risk. In the first step, the EPA determines whether risks are acceptable. This determination “considers all health information, including risk estimation uncertainty, and includes a presumptive limit on maximum individual lifetime [cancer] risk (MIR) of approximately 1 in 10 thousand [ i.e., 100-in-1 million]” (54 FR 38045). In the second step of the process, the EPA sets the standard at a level that provides an ample margin of safety “in consideration of all health information, including the number of persons at risk levels higher than approximately 1-in-1 million, as well as other relevant factors, including costs and economic impacts, technological feasibility, and other factors relevant to each particular decision” ( Id. )

In the 2012 RTR, we finalized the following requirements under CAA section 112(d)(6) and the acceptability determination under CAA section 112(f)(2):

• fugitive emission work practices,

• enclosure for fugitive emission sources, and

• a requirement limiting stack lead emissions to 0.2 mg/dscm as a facility-wide emissions average and limiting stack lead emissions from any single stack to 1.0 mg/dscm.

In the residual risk assessment for the 2012 RTR, we estimated that these requirements would reduce the cancer risk associated with arsenic and cadmium from 200-in-1 million to 10-in-1 million for MACT-allowable emissions and from 50-in-1 million to 10-in-1 million for actual emissions. In the 2012 rule, the maximum acute HQ value for arsenic was expected to be reduced from 20 to 5. We note that we changed our acute risk methodology in 2019 from using the worst-case air dispersion conditions ( i.e., the worst hour) to using the reasonable worst-case air dispersion conditions ( i.e., 99th percentile). If we were to estimate the acute risk using the updated acute risk approach, we anticipate it would be significantly less than estimated in the 2012 RTR. In the 2012 RTR, we estimated that the multipathway cancer risk from ingestion of dioxin was less than 1.

The risks described above were considered acceptable. As required, we performed an ample margin of safety analysis to determine whether risks could be further reduced. In the Secondary Lead Smelting NESHAP proposal  84 and in the final rule, 85 the EPA presented the ample margin of safety analysis and the resulting decision. The ample margin of safety analysis did not focus only on costs as alleged by the petitioner. In addition to costs, we considered the human health impacts, availability of controls, and technical feasibility of applying available controls. We performed an ample margin of safety analysis for the source category that included consideration of multiple emissions sources, including sources that emit the following HAP: (1) arsenic and cadmium, (2) lead compounds, (3) dioxins and furans, (4) organic HAP, and (5) mercury compounds. The results of the ample margin of safety analysis are provided in the following paragraphs.

i. Arsenic and Cadmium: For fugitive emissions sources of arsenic and cadmium, we did not identify any additional feasible control options beyond what we required under acceptability. Therefore, we did not promulgate additional fugitive controls based on our ample margin of safety analysis. For stack emissions of arsenic and cadmium, we identified the addition of a WESP as a potential control. However, we found that stack emissions of arsenic and cadmium did not appreciably contribute to the 10-in-1 million cancer risks remaining after implementation of the controls under acceptability (cancer risks were largely driven by fugitive emissions of arsenic and cadmium). Moreover, we concluded that the likelihood of significant noncancer effects due to post-control arsenic emissions would be very low because the maximum acute noncancer HQ was estimated to be 5, and the assessment was based on a very conservative analysis using some worst-case assumptions (as indicated above, using the updated acute methodology, the HQ would likely be significantly lower). Furthermore, the costs for these additional controls were high: total capital costs were $400 million, and the total annualized costs were $55 million ($4 million/ton of metal HAP emissions reduced). Therefore, we did not promulgate standards based on the installation of a WESP under the ample margin of safety analysis.

ii. Lead: In the 2012 RTR, we finalized requirements under CAA sections 112(d)(6) and (f)(2) lowering the facility-wide emissions limit to a flow-weighted average of 0.20 mg/dscm, limiting the emissions from any one stack to no more than 1.0 mg/dscm, and requiring facilities to fully enclose process fugitive emissions sources and fugitive dust sources. These actions reduced the actual and MACT-allowable lead emissions from this source category to a level that would not result in off-site concentrations above the NAAQS. Moreover, we did not identify any further feasible and cost-effective controls. Thus, we determined that additional lead controls beyond those required under CAA sections 112(d)(6) and (f)(2) were not needed to provide an ample margin of safety to protect public health.

iii. Dioxins and Furans: We promulgated various emissions limits for D/F emissions in the final rule, 86 under CAA section 112(d)(2) and (3). At proposal, results of the multipathway risk assessment indicated that the ingestion cancer risk associated with dioxin and furan emissions was 30-in-1 million. Following proposal, new dioxins and furans emissions data were obtained for the industry. We revised the multipathway risk assessment based on these new data and found that the ingestion cancer risk associated with dioxin and furan emissions was less than 1-in-1 million. Because the maximum individual risk is less than 1-in-1 million, we determined that reductions in emissions of dioxins and furans beyond those achieved by the MACT standards were not needed to provide an ample margin of safety to the public.

iv. Organic HAP: For organic HAP (other than dioxins and furans), we estimated that actual emissions did not result in a cancer risk above 1-in-1 million at any facility in this source category. Given that actual emissions from blast furnaces did not result in a cancer risk above 1-in-1 million and the actual THC emissions modeled from blast furnaces were at levels close to the allowable emissions, we concluded that the cancer risk associated with actual and allowable emissions of organic HAP from all other furnace types are not likely to be greater than 1-in-1 million since the THC limit for blast furnaces is considerably higher than for other furnace types. Additionally, emissions of organic HAP from this source category do not appreciably contribute to any chronic noncancer risk. For these reasons, we determined that additional organic HAP reductions were not needed to provide an ample margin of safety.

v. Mercury: With regard to mercury emissions from this source category, our risk assessment indicated that, even based on our highly conservative estimates of mercury emissions, emissions of mercury did not appreciably contribute to risk based on both the inhalation and multipathway risk analyses. Given that the work practice standard for mercury is based on actual performance of the industry, we determined that more stringent mercury standards were not required to provide an ample margin of safety to protect public health.

Therefore, in conclusion, we have illustrated above that in the 2011 RTR proposal and 2012 RTR final rule, the EPA presented the ample margin of safety analysis and the resulting decision. The ample margin of safety analysis did not focus only on costs as alleged by the petitioner. In addition to costs, we considered the human health impacts, availability of controls, and technical feasibility of applying available controls. The EPA is soliciting comment on the determination the Secondary Lead Smelting NESHAP provides an ample margin of safety (Question #14).

Petitioners maintain that it was not feasible to comment on the accidental release threshold and the paved road exemption for limited use roads which were promulgated as part of work practice standards in the 2012 RTR. We are not making any changes to the work practice standards in the 2012 RTR. However, we are requesting public comment on the accidental release threshold (Question #15) and the paved road exemption for limited use roads (Question #16). The EPA will not respond to comments addressing any other issues or any other provisions of the 2012 rule not specifically addressed in this proposed rulemaking.

In addition to the proposed actions described above, we are proposing additional revisions to the NESHAP. We are proposing revisions to the SSM provisions of the NESHAP in order to ensure that they are consistent with the decision in Sierra Club v. EPA, 551 F.3d 1019 (D.C. Cir. 2008), in which the court vacated two provisions that exempted sources from the requirement to comply with otherwise applicable CAA section 112(d) emission standards during periods of SSM. We also are proposing other revisions to the General Provisions table (Table 1), electronic reporting, and affirmative defense provisions. Our analyses and proposed changes related to these issues are discussed below.

Consistent with Sierra Club v. EPA, 551 F.3d 1019 (D.C. Cir. 2008), which held that under CAA section 302(k), emissions standards or limitations must be continuous in nature and that the SSM exemption violates the CAA's requirement that some section 112 standards apply continuously, the EPA established standards in the Secondary Lead Smelting NESHAP for all periods of operation and removed references to SSM provisions. 87 As part of this proposal, we are addressing outstanding SSM provisions by proposing to revise the General Provisions Applicability Table (table 1) entries (Question #17) as follows:

• 40 CFR 63.8(d)(3): change the “Yes, except for last sentence.” in column “Applies to Subpart X” to “No” and add a comment “See § 63.550(c)(15)” which includes written CMS procedures.

• 40 CFR 63.10(b)(2)(i): add a comment “See § 63.550(e)(13) for recordkeeping for startup and shutdown.”

• 40 CFR 63.10(b)(2)(ii): revise the comment to include references to 40 CFR 63.550(c)(11) and (12) for recordkeeping related to malfunctions.

• 40 CFR 63.10(b)(2)(iv)-(b)(2)(v): add a comment “See § 63.550(c)(13)” for identifying excess emissions.

• 40 CFR 63.10(c)(10)-(11): revise the comment to include references to 40 CFR 63.550(c)(11) and (12) for recordkeeping related to malfunctions.

• 40 CFR 63.10(d)(5): revise the comment to include a reference to 40 CFR 63.550(e)(13).

Additionally, we are proposing to revise the references to no standards for D/F for periods of startup and shutdown from 40 CFR 63.543(c) and from Table 2. The EPA recognizes dioxins and furans will not be emitted during those periods. We are proposing work practices standards during startup and shutdown where facilities ensure scrap feed materials (including chlorinated plastics and flame retardants) that contain the precursors needed for dioxin formation are not introduced into the smelter so there are no conditions that could give rise to D/F emissions. The EPA is soliciting comment on the proposed work practice standards for D/F during startup and shutdown (Question #18).

We are also proposing to amend the General Provisions Applicability Table entries (Question #19) as listed below to address changes in the general provisions since the last rulemaking:

• 40 CFR 63.6(c)(1), (2): change the “Yes” in column “Applies to Subpart X” to a “No” and add the comment, “see § 63.546.”

• 40 CFR 63.6(c)(3), (4): change the “Yes” in column “Applies to Subpart X” to a “No” and add the comment, “Section Reserved.”

• 40 CFR 63.6(f)(2)-(3): add “Yes” in the column “Applies to Subpart X.”

• 40 CFR 63.9(k): Removing the comment “Only as specified in 63.9(j).”

• 40 CFR 63.10(d)(1)-(4): add 40 CFR 63.10(d)(1), 63.10(d)(2), 63.10(d)(3), and 63.10(d)(4), add “No” to column “Applies to Subpart X” and comment, “see § 63.9(k)” for 40 CFR 63.10(d)(2), add “No” to column “Applies to Subpart X” for 40 CFR 63.10(d)(3), add “Yes” to column “Applies to Subpart X” for 40 CFR 63.10(d)(4).

• 40 CFR 63.12 to 63.15: Change to 40 CFR 63.12 to 63.16.

The EPA is proposing to update and expand the electronic reporting requirements to which owners and operators of secondary lead smelting facilities are subject. The following report types (initial notification of compliance, performance test reports, results of CEM performance evaluations, Notification of Compliance Status (NOCS), and semiannual excess emissions and CMS performance reports and summary reports) will be submitted through the EPA's Central Data Exchange (CDX) using the Compliance and Emissions Data Reporting Interface (CEDRI). A description of the electronic data submission process is provided in the memorandum Electronic Reporting Requirements for New Source Performance Standards (NSPS) and National Emission Standards for Hazardous Air Pollutants (NESHAP) Rules, available in the docket for this action. Performance test results and performance evaluation results of continuous emissions monitoring systems (CEMS) relative accuracy test audits (RATAs) have been required to be submitted electronically since January 1, 2012. We are proposing to revise the regulatory text to reference the general provisions and that the initial notification of compliance and the NOCS reports be submitted as a PDF upload in CEDRI (Question #20).

For the semiannual excess emissions and CMS performance reports and summary reports, we are proposing at 40 CFR 63.550(e)(15)(iii) that owners and operators use the appropriate spreadsheet template to submit information to CEDRI. The EPA is proposing to revise the recordkeeping and reporting requirements at 40 CFR 63.550(c) and (e) which is reflected in the template. A draft version of the proposed template for these reports is included in the docket for this action. 88 The EPA specifically requests comment on the content, layout, and overall design of the template (Question #21).

The electronic submittal of the reports addressed in this proposed rulemaking will increase the usefulness of the data contained in those reports, is in keeping with current trends in data availability and transparency, will further assist in the protection of public health and the environment, will improve compliance by facilitating the ability of regulated facilities to demonstrate compliance with requirements and by facilitating the ability of delegated state, local, tribal, and territorial air agencies and the EPA to assess and determine compliance, and will ultimately reduce burden on regulated facilities, delegated air agencies, and the EPA. Electronic reporting also eliminates paper-based, manual processes, thereby saving time and resources, simplifying data entry, eliminating redundancies, minimizing data reporting errors, and providing data quickly and accurately to the affected facilities, air agencies, the EPA, and the public.

As part of the 2012 RTR  89 the EPA included the ability to assert an affirmative defense to civil penalties for violations caused by malfunctions. 90 Although the EPA recognized that its case-by-case enforcement discretion provided sufficient flexibility under such circumstances, we included the affirmative defense provision to provide a more formalized approach and greater regulatory clarity. Under the EPA's regulatory affirmative defense provisions, if a source could demonstrate in a judicial or administrative proceeding that it had met the requirements of the affirmative defense in the regulation, civil penalties would not be assessed. However, in NRDC, the D.C. Circuit vacated an affirmative defense provision in another CAA section 112 regulation, finding that the EPA lacked authority to establish such an affirmative defense because the authority to determine civil penalty amounts in such cases lies exclusively with the courts, not the EPA. 91 In response to this decision, the EPA is proposing to remove the affirmative defense provisions previously established in the Secondary Lead Smelting NESHAP at 40 CFR 63.552 in their entirety and the definition of “affirmative defense” at 40 CFR 63.542. The EPA initially added the affirmative defense provisions in the Secondary Lead Smelting NESHAP in 2012, specifically describing the affirmative defense in the preamble as an “affirmative defense to civil penalties for exceedances of emission limits that are caused by malfunctions.”  92 The regulatory language narrowly defines this affirmative defense as an “affirmative defense to civil penalties for exceedances of emissions limit during malfunction.”  93 As explained above, if a source is unable to comply with emissions standards as a result of a malfunction, the EPA may use its case-by-case enforcement discretion to provide flexibility, as appropriate. Further, as the court recognized in the NRDC decision, in an EPA or citizen enforcement action, the court has the discretion to consider any defense raised and determine whether penalties are appropriate. 94 The same is true for the presiding officer in EPA administrative enforcement actions.

The EPA previously proposed to remove the affirmative defense provisions from the Secondary Lead Smelting NESHAP as part of a proposed rule entitled Removal of Affirmative Defense Provisions from Specified New Source Performance Standards and National Emissions Standards for Hazardous Air Pollutants. 95 We now propose the removal of these provisions as part of this action. We are soliciting comment on our proposal to remove the affirmative defense provisions from the Secondary Lead Smelting NESHAP as part of this rulemaking (Question #22). Comments previously submitted on the prior proposed rule will not be considered as part of this action and must be submitted to the docket for this action in order to be considered. 96

Additionally, on September 5, 2025, the D.C. Circuit held in SSM Litigation Group v. EPA, Case No. 23-1267, that although EPA has no authority under the CAA to “create a regulatory `defense' that limits the remedial authority granted by Congress to the federal courts,” a “complete affirmative defense, like the one at issue [in that case], is permissible because it relates to the antecedent question of liability and therefore does not impinge on the judiciary's authority to award `appropriate civil penalties.' ”  97 As previously noted, this affirmative defense provision for which EPA is now proposing removal is only for civil penalties and is not a complete affirmative defense as contemplated by the D.C. Circuit in the SSM Litigation Group decision. Due to the timing of the D.C. Circuit's decision in SSM Litigation Group and the Agency's consent decree deadline to issue this proposed action, the Agency is proposing to remove the existing affirmative defense in response to the NRDC decision while reserving the issue of affirmative defenses more generally for the future.

The EPA therefore requests comment on whether and how we should establish regulations within this and other New Source Performance Standards or NESHAPs in response to the D.C. Circuit's SSM Litigation Group decision. Due to the timing of the D.C. Circuit decision and the Agency's consent decree deadline, the EPA will address the impacts of the SSM Litigation Group decision in an appropriate future action. The EPA is soliciting comment on the proposed removal of this affirmative defense provision for civil penalties (Question #23).

On February 5, 2016, the EPA received a petition for a new rulemaking from Sierra Club and California Communities Against Toxics. 98 The petition requested that the EPA revise the provisions on applicability and definitions in the Secondary Lead Smelting NESHAP. The petition was submitted in response to a published notice of proposed action on an application for an operating permit submitted by Aqua Metals, Inc. to the Nevada Department of Environmental Protection. The permit concerned plans to construct and operate a used lead acid battery recycler, also known as a secondary lead processing facility. The proposed facility intended to recycle lead acid car batteries using hydrometallurgical and electrometallurgical lead processing techniques rather than using typical pyrometallurgic lead technology. The permit application did not include terms or conditions to comply with the Secondary Lead Smelting NESHAP, as the facility did not believe the NESHAP was applicable due to the applicability requirements and current definitions of affected sources. This facility later shut down, and hence the EPA did not act on the petition. The EPA has recently been notified of a new facility intending to operate a secondary lead recycling facility that will operate non-pyrometallurgic lead recycling processes. The EPA is requesting information about these non-pyrometallurgic processes to aid in determining the most appropriate way to address this type of secondary lead recycling (Question #24).

The proposed amendments to the Secondary Lead Smelting NESHAP in this action are subject to the compliance timeframes in CAA section 112(i). 99 We expect most existing sources can comply with the amendments without modification.

We are proposing the following amendment to be effective upon publication of the final rule: the provision that a performance test extension request will be deemed approved under certain circumstances; and the use of fan amperage to demonstrate compliance with the total enclosure requirement as an alternative to differential pressure monitoring.

We are proposing to allow six months to comply with the amendments to recordkeeping and reporting of malfunctions and deviations and the D/F work practice standards during startup and shutdown and the increased averaging period for differential pressure monitoring. This additional compliance time allows facilities to read and the requirements and modify their procedures accordingly.

We are proposing to allow one year for the use of the CEDRI reporting template and compliance with the D/F and THC limits for collocated rotary and reverberatory furnaces. For the CEDRI reporting template we are proposing, facilities submit semiannual excess emissions and CMS performance reports to the Administrator using the template beginning 1 year after publication of the final rule in the Federal Register or once the report template for 40 CFR part 63, subpart X has been available on the CEDRI website for one year, whichever date is later.

The EPA estimates that only one existing source would need time to comply with the proposed collocated rotary and reverberatory furnace limits. This facility needs time to establish contracts with testing companies and arrange for and conduct the performance testing. Therefore, we are proposing to allow one year for existing sources to comply with the collocated rotary and reverberatory furnace THC and D/F emission limits.

As provided in CAA section 112(i), for all affected sources that commenced construction or reconstruction after October 1, 2025, we are proposing that owners and operators comply with the provisions by the effective date of the final rule (or upon startup, whichever is later). The effective date is the date of publication of the final amendments in the Federal Register .

We solicit comment on these proposed compliance periods, and we specifically request submission of information from sources in this source category regarding specific actions that would need to be undertaken to comply with the proposed amended provisions and the time needed to make the adjustments for compliance with any of the revised provisions (Question #25).

There are currently 11 secondary lead smelting facilities in the United States. The list of facilities is available in the document titled List of Facilities Subject to the Secondary Lead Smelting NESHAP, which is available in the docket for this rulemaking. 100 We anticipate that no new secondary lead smelting facilities, as currently defined, will become subject to the NESHAP in the next eight years.

We do not anticipate any air quality impacts due to this rulemaking. We are setting a MACT Floor for THC and D/F rotary furnaces but do not anticipate any reductions of THC and D/F. There is only one collocated rotary and reverberatory furnace in the source category and the limit reflects current controls on this furnace.

We anticipate limited costs associated with this rulemaking. The THC and D/F testing requirement for collocated rotary and reverberatory furnaces only applies to one facility. We anticipate the costs of testing and recordkeeping and reporting to be approximately $70,700 for the first year of testing. The estimated D/F testing costs every 6 years are $30,000 per test and the estimated annual THC testing costs are $10,000 per test. The estimated recordkeeping and reporting costs are $30,700 for the first year.

As described above, costs were estimated for the first 8 years (2027—2034) following this action. This allows for a reasonable and consistent timeframe over which to examine impacts of this action from a present value (PV) perspective. The PV in 2023 dollars is a cost of approximately $180,000 using a 3 percent discount rate and $160,000 using a using a 7 percent discount rate. The equivalent annualized value in 2023 dollars is a cost of approximately $26,000 using a discount rate of 3 percent and $26,000 using a discount rate of 7 percent. Given the results of the analysis, these economic impacts are relatively low for affected industries and entities impacted by this proposed rule, and there will not be substantial impacts on the markets for affected products. The costs of the proposed rule are not expected to result in a significant market impact, regardless of whether they are passed on to the purchaser or absorbed by the companies.

The EPA performed a screening analysis to assess potential impacts of this action on small entities. Based on the small entity size standards defined by the U.S. Small Business Administration (SBA), the EPA determined that 4 of the 11 facilities affected by this action are ultimately owned by parent companies that are small entities. None of these small entities are expected to incur significant impacts. The only entity that is expected to be impacted by the additional testing costs from this rule is not considered a small business. Therefore, the EPA has determined that this rule will not have a significant impact on a substantial number of small entities ( i.e., no SISNOSE).

We do not anticipate emissions reductions from the proposed THC and D/F standards for collocated rotary and reverberatory furnaces. Some benefits may result from the revised provision allowing a 24-month extension for compliance testing, if finalized as proposed, as the requirements to receive the extension will encourage facilities to operate below 50 percent of the lead and THC limits, encouraging individual facilities to be top performers for emissions reductions. We are unsure of the number of facilities that may meet the requirements. Therefore, we cannot estimate potential benefits of this proposed provision.

We solicit comments on this proposed action. In addition to general comments on this proposed action, we are also interested in additional data that may improve the analyses. We are specifically interested in receiving any information regarding developments in practices, processes, and control technologies that reduce HAP emissions.

The EPA is soliciting comment on the following:

• Question #1: Whether we should consider any additional developments not addressed here or in the technical memorandum.

• Question #2: On the determination that a baghouse routed to a WESP is not cost-effective.

• Question #3: Our determination not to propose fenceline monitoring for the secondary lead smelting source category.

• Question #4: The proposed THC and D/F limits and beyond-the-floor rationale.

• Question #5: The proposed collocated rotary and reverberatory furnace definition.

• Question #6: On setting the THC and D/F standards pursuant to CAA section 112(d)(6) rather than setting the THC and D/F standards exclusively pursuant to CAA section 112(d)(2) and (3).

• Question #7: On proposing THC as a surrogate for COS.

• Question #8: On whether the Agency's proposed de minimis treatment here for HCl and Cl 2 for the secondary lead smelting source category could be considered a change in Agency position.

• Question #9: On all aspects of the Agency's proposed determination, including the Agency's statutory interpretation and factual findings.

• Question #10: On whether to adopt a MACT HCl limit of 0.03 lb/hr in lieu of the de minimis determination.

• Question #11: On increasing the differential pressure monitor averaging time.

• Question #12: On allowing monitoring of total enclosure at negative pressure through the use of fan amperage.

• Question # 13: On the approval of the 24-month testing extensions under certain circumstances.

• Question #14: On the determination the Secondary Lead Smelting NESHAP provides an ample margin of safety.

• Question #15: On the accidental release threshold.

• Question #16: On the paved road exemption for limited use roads.

• Question #17: On changes removing the General Provisions Applicability Table (Table 1) entries to address SSM.

• Question #18: On the proposed work practice standards for D/F during startup and shutdown.

• Question #19: On the proposed changes to the General Provisions Applicability Table entries.

• Question #20: On the proposed changes regulatory text to reference the general provisions and that the initial notification of compliance and the NOCS reports be submitted as a PDF upload in CEDRI.

• Question #21: On the content, layout, and overall design of the template.

• Question #22: On our proposal to remove the affirmative defense provisions from the Secondary Lead Smelting NESHAP as part of this rulemaking.

• Question #23: On the proposed removal of the affirmative defense provision for civil penalties.

• Question #24: On the non-pyrometallurgic processes to aid in determining the most appropriate way to address non-pyrometallurgic secondary lead recycling.

• Question #25: On the proposed compliance periods, and we specifically request submission of information from sources in this source category regarding specific actions that would need to be undertaken to comply with the proposed amended provisions and the time needed to make the adjustments for compliance with any of the revised provisions.

• Question #26: On the EPA's need for this information, the accuracy of the provided burden estimates and any suggested methods for minimizing respondent burden to the EPA using the docket identified at the beginning of this rule.

• Question #27: Any potentially applicable VCS and to explain why such standards should be used in this regulation.

Additional information about these statutes and Executive Orders can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.

This action is not a significant regulatory action and was therefore not submitted to the OMB for review.

This action is not expected to be an Executive Order 14192 regulatory action because this action is not significant under Executive Order 12866.

The information collection activities in this proposed rule have been submitted for approval to the OMB under the PRA. The ICR document that the EPA prepared has been assigned EPA ICR number 2060-0296. You can find a copy of the ICR in the docket for this rule, and it is briefly summarized here.

Respondents/affected entities: Owners or operators of secondary lead smelting facilities.

Respondent's obligation to respond: Mandatory (40 CFR part 63, subpart X).

Estimated number of respondents: 11.

Frequency of response: Initially, semiannually, and annually.

Total estimated burden: 100 hours (per year). Burden is defined at 5 CFR 1320.3(b).

Total estimated cost: Average annual cost is $34,000 (per year) which includes $0 annualized capital or operation and maintenance costs.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for the EPA's regulations in 40 CFR are listed in 40 CFR part 9.

Submit your comments on the EPA's need for this information, the accuracy of the provided burden estimates and any suggested methods for minimizing respondent burden to the EPA using the docket identified at the beginning of this rule (Question #26). You may also send your ICR-related comments to OMB's Office of Information and Regulatory Affairs via email to OIRA_submission@omb.eop.gov, Attention: Desk Officer for the EPA. Since OMB is required to make a decision concerning the ICR between 30 and 60 days after receipt, OMB must receive comments no later than October 31, 2025. The EPA will respond to any ICR-related comments in the final rule.

I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. In making this determination, the EPA concludes that the impact of concern for this rule is any significant adverse economic impact on small entities and that the EPA is certifying that this rule will not have a significant economic impact on a substantial number of small entities because the rule has no net burden on the small entities subject to the rule. We identified that four of the 11 facilities in the secondary lead smelting source category affected by this proposed action are small businesses. The EIA conducted for this proposal (see Economic Impact Analysis, which is available in the docket for this action) showed that the small businesses will not incur total annualized costs greater than 1 percent of their revenue. We have therefore concluded that this action will have no net regulatory burden for all directly regulated small entities.

This action does not contain an unfunded mandate of $100 million (adjusted annually for inflation) or more (in 1995 dollars) as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The costs involved in this action are estimated not to exceed $187 million in 2024$ ($100 million in 1995$ adjusted for inflation using the gross domestic product implicit price deflator) or more in any 1 year.

This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.

This action does not have tribal implications as specified in Executive Order 13175. None of the facilities that have been identified as being affected by this action are owned or operated by tribal governments or are located within tribal lands. Thus, Executive Order 13175 does not apply to this action.

Executive Order 13045 directs Federal agencies to include an evaluation of the health and safety effects of the planned regulation on children in Federal health and safety standards and explain why the regulation is preferable to potentially effective and reasonably feasible alternatives. This action is not subject to Executive Order 13045 because the EPA does not believe the environmental health risks or safety risks addressed by this action present a disproportionate risk to children. Emissions from this source category include HAP like lead and arsenic which are known developmental toxicants. However, the controls required in 2012 already reduced the modeled exposure to HAP from these facilities to below levels of public health concern (77 FR 556; January 5, 2012). Therefore, this action does not present or address disproportionate risk to children. However, the EPA's Policy on Children's Health applies to this action.

The EPA does not believe there are disproportionate risks to children because the Secondary Lead Smelting NESHAP currently has lead emissions limits for process vents and process fugitives. In 2012, we estimated the required controls would result in modeled lead concentrations such that there would be no one living at a census block centroid exposed to ambient concentrations above the NAAQS, thereby mitigating the risk of future adverse health effects to children. The modeled concentration data are supported by fenceline monitoring conducted during the CAA section 114 information request which showed ambient lead levels well below the lead NAAQS limit of 0.15 micrograms per cubic meter 3-month rolling average limit at the fenceline for all but one facility (this one facility is currently subject to a state consent agreement). The fenceline monitoring conducted also included testing for arsenic which we found to be below levels of concern. Additionally, we are updating monitoring, recordkeeping, and reporting requirements to help improve compliance reporting, which also benefits children's health.

This action is not subject to Executive Order 13211, because it is not a significant regulatory action under Executive Order 12866.

This action involves technical standards. The EPA proposes to use the voluntary consensus standard (VCS) discussed below. The EPA searched the Enhanced National Standards Service Network (NSSN) database maintained by the American National Standards Institute (ANSI) for VCS that could be used in the Secondary Lead Smelting NESHAP. While we have made a reasonable effort to identify and evaluate potentially practical VCS, our findings do not necessarily represent all potential alternative standards which may exist.

Searches were conducted for EPA Methods 1, 2, 3A, 3B, 4, 5D, 12, 23, 25A, and 29 of 40 CFR part 60, appendix A. We found no VCS are acceptable alternatives for EPA Methods 1, 2, 3A, 4, 5D, 12, 23, 25A and 29.

One VCS is an acceptable alternative to EPA Method 3B for this rule. The manual methods in ANSI/ASME PTC 19-10-1981 Part 10, “Flue and Exhaust Gas Analyses” (2010 version) are acceptable alternatives to EPA Method 3B to analyze O 2 and carbon dioxide (CO 2 ) concentrations in the stack gas. The instrumental methods in the VCS ANSI/ASME PTC 19-10-1981 Part 10, “Flue and Exhaust Gas Analyses” (2010 version) are not acceptable alternatives to EPA Method 3B. The manual methods are available at the ANSI, 1899 L Street NW, 11th Floor, Washington, DC 20036 and the American Society of Mechanical Engineers (ASME), Three Park Avenue, New York, NY 10016-5990; telephone number: 1-800-843-5990; and email address: customercare@asme.org. See www.ansi.org and www.asme.org. The standard is available to everyone at a cost determined by ANSI/ASME ($88). ANSI/ASME also offer memberships or subscriptions for reduced costs. The cost of obtaining these methods is not a significant financial burden, making the methods reasonably available.

Under 40 CFR 63.7(f) and 40 CFR 63.8(f), subpart A—General Provisions, a source may apply to the EPA for permission to use alternative test methods or alternative monitoring requirements in place of any required testing methods, performance specifications, or procedures in the final rule or any amendments.

The EPA welcomes comments on this aspect of the proposed rulemaking and, specifically, invites the public to identify potentially applicable VCS and to explain why such standards should be used in this regulation (Question #27).

The EPA proposes to amend 40 CFR 63.14 to incorporate by reference for one VCS: ANSI/ASME PTC 19.10-1981, Flue and Exhaust Gas Analysis [Part 10, Instruments and Apparatus], issued August 31, 1981, IBR requested for 40 CFR 63.1450(a)(iii), (b)(iii), (d)(iii), and (e)(iii). This method is an approved alternative to EPA Method 3B manual portion only, not the instrumental portion. The applicable portion of this Performance Test Code is the wet chemical manual procedures, apparatus and calculations for quantitatively determining O 2 , CO 2 , carbon monoxide and nitrogen from stationary combustion sources.

DOT is issuing this supplemental notice of proposed rulemaking (SNPRM) following issuance of a 2024 notice of proposed rulemaking (NPRM) to amend its drug testing procedures rule. ( See 89 FR 97579.) The NPRM proposed an interim provision to require the conduct of directly observed urine tests in the limited situations where the rule requires oral fluid tests, but oral fluid testing is not yet available. DOT continues to propose a directly observed urine collection in situations where oral fluid tests are currently required, but oral fluid testing is not yet available and supplements that proposal by updating language in its drug and alcohol testing regulations consistent with E.O. 14168 on Defending Women from Gender Ideology Extremism and Restoring Biological Truth to the Federal Government.

This rulemaking is promulgated pursuant to the Omnibus Transportation Employee Testing Act of 1991 (OTETA) (Pub. L. 102-143, Tit. V, 105 Stat. 952). DOT requires urine drug testing and authorizes oral fluid drug testing as an alternative methodology for the testing of safety-sensitive transportation industry employees subject to drug testing under part 40 of Title 49 of the Code of Federal Regulations (part 40). DOT's part 40 regulations are, in turn, incorporated by reference in the drug and alcohol testing requirements of each of its operating administrations. 1

DOT published a final rule amending the procedures for its drug testing program (49 CFR part 40) on May 2, 2023 (88 FR 27596) (May 2023 Final Rule). The May 2023 Final Rule went into effect on June 1, 2023. The May 2023 Final Rule authorized oral fluid drug testing as an additional methodology for employers to use as a means of achieving the safety goals of the program. Because the Department of Health and Human Services (HHS) had determined that oral fluid drug testing, like urine drug testing, is both scientifically accurate and forensically defensible, DOT saw no reason to eliminate or mandate either methodology. As such, in the vast majority of collection scenarios, oral fluid testing is available to employers as an alternate methodology to choose, and not as a replacement for urine drug testing.

Importantly, for an employer to implement oral fluid testing, there must be at least two HHS-certified laboratories for oral fluid testing. There must be one HHS-certified laboratory to conduct the screening and confirmation drug testing on the primary specimen. There must be a different HHS-certified laboratory to conduct the split specimen drug testing on the secondary specimen if the employee requests split specimen testing for the Medical Review Officer (MRO) verified positive, adulterated, or substituted result. However, as of the date of the publication of this rule, there are no HHS-certified laboratories to conduct oral fluid testing. 2

DOT regulations at § 40.67 require that a collection be directly observed in certain circumstances, e.g., if the original sample was invalid without an adequate medical explanation or the test is for a return to duty. In the May 2023 Final Rule, and in response to comments received on the notice of proposed rulemaking (NPRM) that preceded that rule, we added a provision at § 40.67(g)(3) to require a directly observed collection to be an oral fluid test  3 (as opposed to a urine test) in situations where an observer as required by the regulations cannot be easily provided and in certain other situations. These limited situations are the only ones in which Part 40 expressly requires an oral fluid test to be conducted as opposed to a urine test; in all other situations, an employer has the choice of whether a urine test or an oral fluid test will be conducted, including those conducted as directly observed collections.

Because there are no HHS-certified oral fluid laboratories, it is not yet possible to comply with the requirement in § 40.67(g)(3) that requires the directly observed collection to be an oral fluid test in the situations specified in that section. In the interim, and to preserve transportation safety by deterring illicit drug use, it is necessary to ensure that directly observed collections can still be conducted when required.

To correct the inadvertent factual impossibility created by the fact there are no HHS certified oral fluid laboratories, DOT published an NPRM on December 9, 2024, proposing to amend Part 40, for an interim period, to require directly observed urine collections in the situations specified in § 40.67(g)(3) if an oral fluid collection is not yet available (89 FR 97579). The proposed amendment would simply maintain the “status quo” wherein all directly observed collections are currently conducted as urine tests, because oral fluid testing is not yet available.

The Department stated that the amendment to require directly observed urine tests in situations where an oral fluid collection is required, but is not yet available, is intended to be a temporary, short-term solution, as there are currently no certified oral fluid laboratories. DOT proposed that the provision would sunset one year after HHS publishes a Federal Register notice that it certified the second oral fluid drug testing laboratory. To ensure all are aware of the date when this provision will sunset, DOT stated it will publish a Federal Register document specifying the date the second oral fluid laboratory is certified by HHS and the corresponding sunset date. Importantly, DOT was clear that if, during the interim period, a collection site is able to conduct an oral fluid collection (HHS has certified at least two oral fluid drug testing laboratories, and both a qualified oral fluid collector and a conforming oral fluid collection device are available at the collection site), an oral fluid collection would be required to be conducted as specified in § 40.67(g)(3).

DOT received 22 comments on the NPRM. Several commenters expressed concern and frustration that oral fluid testing is not yet available, given that the May 2023 Final Rule that authorized the use of oral fluid testing in the DOT drug testing program became effective on June 1, 2023. DOT made it clear in the May 2023 Final Rule, and we have again noted above, there must be at least two HHS-certified laboratories for oral fluid testing for an employer to implement oral fluid testing under Part 40. HHS is the agency that establishes scientific and technical guidelines for Federal workplace drug testing programs and standards for certification of laboratories engaged in such drug testing. While DOT has discretion concerning many aspects of its regulations governing testing in the transportation industries' regulated programs, DOT is required, by statute (OTETA of 1991), to follow the HHS Mandatory Guidelines for the laboratory and specimen testing procedures. While DOT acknowledges the comments urging DOT to accelerate/expedite the certification of laboratories to conduct oral fluid testing, DOT has no authority or jurisdiction to do so because HHS is the agency that certifies laboratories that can be used in the DOT drug testing program. Similarly, DOT is not permitted to allow single-laboratory testing on a temporary basis as recommended by one commenter, as statutory law (again, OTETA of 1991) gives employees the right to request a test of the split specimen sample, which must be tested independently at a second HHS-certified laboratory. Because HHS certifies laboratories, comments related to laboratory certification are outside of the scope of this rulemaking.

Several commenters expressed concerns regarding various issues related to oral fluid testing, including the qualification of oral fluid collectors, the availability and cost of oral fluid collection devices, and other associated issues. In addition, some commenters seem to believe that the NPRM proposed to delay implementation of oral fluid testing in general, which is not the case. The scope of the NPRM was very narrow, and proposed to revert to directly observed urine collections in situations where a required oral fluid collection could not be done until two laboratories are certified for oral fluid testing by HHS. As such, these commenters' concerns about oral fluid testing are similarly outside of the scope of this rulemaking.

Several commenters supported the proposal to conduct directly observed urine collections in the limited situations where an observer as required by the regulations cannot be easily provided or in the circumstances identified in § 40.67(g)(3) but objected to the manner and timeline in which the provision was proposed to be implemented. Specifically, a commenter read the NPRM to “delay and/or make optional 49 CFR section § 40.67(g)(3) for one year from when HHS certifies the first two laboratories to conduct Federal testing.” Other commenters stated similar concerns, citing the comments submitted by this commenter.

In response, DOT notes that in situations where an observer as required by the regulations cannot be easily provided or in the circumstances identified in § 40.67(g)(3), and a directly observed collection is required, DOT was clear that an oral fluid collection must be conducted, if possible ( i.e., HHS has certified at least two oral fluid drug testing laboratories, and both a qualified oral fluid collector and a conforming oral fluid collection device are available at the collection site) during the period until one year after HHS publishes a Federal Register notification that a second oral fluid laboratory has been certified. Otherwise, if oral fluid testing is not available, a directly observed urine test must be conducted in these situations during the specified time period. After one year following the certification of the second oral fluid laboratory, an oral fluid test must be conducted as required in the May 2023 Final Rule. The above aligns directly with the commenter's statement that collection sites with trained personnel prepared to offer oral fluid testing immediately should be allowed to proceed with oral fluid testing.

Several commenters stated that the proposed changes would have a significant economic impact on a number of small entities. These commenters stated that many companies have expended time and costs to revise their company policies to incorporate changes to facilitate oral fluid testing in their drug testing programs, and that these policies will need to be revised again to reflect the changes associated with the provisions to require the conduct of directly observed urine tests in the limited situations where the rule requires oral fluid tests, but oral fluid testing is not yet available. As discussed above, this regulatory flexibility is very narrow in scope, and affects a very small percentage of collections (directly observed collections where an observer as required by the regulations cannot easily be provided or in the specific circumstances specified in § 40.67(g)(3)). As noted below, DOT stated in the May 2023 Final Rule that oral fluid testing is optional except in very rare cases. As such, DOT does not believe that widespread changes will need to be made to the company policies that have been developed to facilitate the implementation of oral fluid testing. Further, employers will not be faced with a “new choice” ( i.e., whether to conduct an oral fluid test or a urine test) in these limited scenarios because the rule requires that an oral fluid test be conducted, if possible, and that a urine test be conducted otherwise.

Finally, in the May 2023 Final Rule in § 40.67(g)(3), DOT included procedures on what to do when the required “observer” cannot be found but mistakenly used the term “collector” instead of “observer” in the regulatory text of that section. We proposed to correct the error in the NPRM and received no comments on this issue.

In § 40.65 there are two scenarios, (b)(5) and (c)(1), that direct the collector to perform either a directly observed urine collection or an oral fluid collection. However, nothing in those sections tells the collector how or who makes that decision. We think it is important to remind the collector to check if the employer has standing orders or contact the Designated Employer Representative (DER) to receive instructions on how to proceed in each of those scenarios. We would do so in the proposed new paragraph (d).

On January 20, 2025, the President issued E.O. 14168 on Defending Women from Gender Ideology Extremism and Restoring Biological Truth to the Federal Government. E.O. 14168 stated, among other things, that it was the policy of the United States to recognize two sexes, male and female, that each Federal agency shall use the term “sex” and not “gender” in its policies and documents, that “sex” shall refer to an individual's immutable biological classification as either male or female and give meaning to the term “sex” as set forth in the E.O. when applying regulations, statutes or guidance. The Department has identified several instances in its regulation 49 CFR part 40 (i.e., §§ 40.67, 40.69, and 40.147) where the word “gender” is used. In these sections, we propose to replace the word “gender” with the word “sex”. E.O. 14168 also states “sex” is not a synonym for and does not include the concept of “gender identity”.

The Department is proposing to amend § 40.67(g)(3) by retaining only the original instructions that require an oral fluid collection when a same sex observer cannot be found with a slight modification to the text in (g)(3)(ii) to say that the DER is to instruct the collector to perform an oral fluid test. The Department is retaining the originally proposed language that requires a directly observed urine collection when an oral fluid collection cannot be done for up to one year after two laboratories are HHS certified for oral fluid testing. This language was proposed to ensure that a urine collection would be done in the event the collection site was not ready to conduct oral fluid collections even after two laboratories were HHS-certified for oral fluid testing. To summarize the supplemental proposal to (g)(3), if a directly observed urine collection is required and a same sex observer cannot be provided, then an oral fluid test is to be performed. However, because oral fluid testing cannot be performed (because there are no two HHS-certified oral fluid laboratories), we have retained the originally proposed language that a directly observed urine collection be performed. This provision applies for one year after HHS certifies at least two oral fluid laboratories. In the interest of safety, if the employee initially provided a suspect urine specimen, we would want to ensure that a second urine collection is performed rather than not performing a second collection because oral fluid testing is not yet available.

This rule is a non-significant rule for purposes of E.O. 12886, as supplemented by E.O. 13563 and amended by E.O. 14094 and will not impose any significant costs or have any significant impacts. Given the uncertainty of testing costs and lack of data on other aspects of testing, DOT did not estimate cost savings or other benefits for the May 2023 Final Rule which permitted oral fluid testing as an alternative to urine testing in most scenarios. In the regulatory analyses for the May 2023 Final Rule, DOT stated that oral fluid testing is optional except in very rare cases. This proposal amends the transportation industry drug testing program procedures regulation to comply with E.O. 14168 and proposes to require a directly observed urine collection be conducted when an oral fluid test is required but cannot because there are no two HHS-certified oral fluid drug testing laboratories. This proposal will not impose any significant costs or have any significant impacts on the DOT testing program, because the requirement of a directly observed urine collection existed before issuance of the May 2023 Final Rule, and oral fluid testing has not yet been able to be conducted since the May 2023 Final Rule in the absence of at least two HHS-certified oral fluid laboratories.

The Regulatory Flexibility Act of 1980 (5 U.S.C. 601 et seq. ) requires Federal agencies to consider the effects of their regulatory actions on small businesses and other small entities and minimize any significant economic impact. The term “small entities” comprises small businesses and not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with a population of less than 50,000. For this rulemaking, potentially affected small entities include drug testing companies (U.S. Small Business Administration (SBA) North American Industry Classification System (NAICS) Sector 54 (Professional, Scientific and Technical Services), Code 541380 (Testing Laboratories and Services)) as well as DOT-regulated entities (SBA NAICS Sectors 48-49 (Transportation and Warehousing)).

The Department does not expect that the rule will have a significant economic impact on a substantial number of small entities. This proposal amends the transportation industry drug testing program procedures regulation to revise language consistent with E.O. 14168 and proposes a requirement to conduct directly observed urine collections in situations when an oral fluid collection is required but not yet available. The requirement for directly observed urine collections was in existence before issuance of the May 2023 Final Rule, and regulated entities are therefore familiar with the procedure for directly observed urine tests. In addition, because oral fluid testing is not yet available, regulated entities are also likely to still have the collection devices and personnel to conduct urine testing. As a result, the proposed amendments will not impose significant costs. For these reasons, I certify that the rule does not have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act.

DOT has examined the impact of this rule under the Unfunded Mandates Reform Act (UMRA) of 1995 (Pub. L. 104-4). This rule does not trigger the requirement for a written statement under sec. 202(a) of the UMRA because this rulemaking does not impose a mandate that results in an expenditure of $206 million or more by either State, local, and Tribal governments in the aggregate or by the private sector in any one year.

DOT has analyzed the environmental impacts of this action pursuant to the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321 et seq. ) and has determined that it is categorically excluded pursuant to DOT Order 5610.1D, “DOT's Procedures for Considering Environmental Impacts” (July 1, 2025) (available at https://www.transportation.gov/mission/dots-procedures-considering-environmental-impacts ). Categorical exclusions are actions identified in an agency's NEPA implementing procedures that do not normally have a significant impact on the environment and therefore do not require either an environmental assessment (EA) or environmental impact statement (EIS). This proposal amends the transportation industry drug testing program procedures regulation to comply with E.O. 14168 and requires a directly observed urine collection when required by part 40 because oral fluid testing is not yet available. This action is covered by the categorical exclusion listed at 23 CFR 771.118(c)(4), “[p]lanning and administrative activities that do not involve or lead directly to construction, such as: . . . promulgation of rules, regulations, directives. . .” The Department does not anticipate any environmental impacts, and there are no extraordinary circumstances present in connection with this rulemaking.

DOT has analyzed the rule in accordance with Executive Order 13132: Federalism. Executive Order 13132 requires Federal agencies carefully to examine actions to determine if they contain policies that have federalism implications or that preempt State law. As defined in the order, “policies that have federalism implications” refer to regulations, legislative comments or proposed legislation, and other policy statements or actions that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government.

Most of the regulated parties under the Department's drug testing program are private entities. Some regulated entities are public entities ( e.g., transit authorities and public works departments); however, DOT has determined that this proposed rule, which would amend the transportation industry drug testing program procedures regulation to comply with E.O. 14168 and require the conduct of directly observed urine testing where employers are required to conduct an oral fluid test but such testing is not available, does not contain policies that have federalism implications.

Executive Order 13175 (65 FR 67249, November 6, 2000) requires Federal agencies to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” as defined in the Executive Order, include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.” This rule does not have Tribal implications. The proposal does not have substantial direct effects on Tribal governments, 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, as specified in Executive Order 13175.

The Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) (PRA) requires that DOT consider the impact of paperwork and other information collection burdens imposed on the public. The information collection for DOT's drug and alcohol testing program is approved under OMB control number 2105-0529. This rule does not require any new collection of information under the PRA. Notwithstanding any other provision of law, no person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a currently valid Office of Management and Budget (OMB) control number.

Anyone is able to search the electronic form of all comments received in any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). For information on DOT's compliance with the Privacy Act, please visit https://www.transportation.gov/privacy.

As required by 5 U.S.C. 553(b)(4), a summary of this rule can be found at regulations.gov, Docket DOT-OST-2021-0093, in the SUMMARY section of this document.

In accordance with Compliance with Pay-As-You-Go Act of 2023 (Fiscal Responsibility Act of 2023, Pub. L. 118-5, div. B, title III) and OMB Memorandum (M-23-21) dated September 1, 2023, the Department has determined that this rule is not subject to the Pay-As-You-Go Act of 2023 because it will not increase direct spending beyond specified thresholds.

For the reasons stated in the preamble, DOT amends 49 CFR part 40 as follows: