In order to be eligible to participate in SNAP, a store must meet either Criterion A (staple food stock) or Criterion B (staple food sales). These requirements were formalized by the final rule titled “Food Stamp Program: Revisions to the Retail Food Store Definition and Program Authorization Guidance” which was published on January 12, 2001 (66 FR 2795). This 2001 final rule implemented changes required by the Food Stamp Program Improvements Act of 1994.

Under this 2001 final rule, Criterion A eligibility was established to require that certain stores carry at least three (3) varieties of staple foods in each of the four (4) staple food categories as well as at least one (1) perishable variety in at least two (2) staple food categories. The staple food categories are: Meat, poultry, or fish; dairy products; bread or cereals; and vegetables or fruits. This 2001 final rule defined the term “variety”, as used with respect to SNAP Criterion A, at 7 CFR 278.1(b)(1)(ii)(C).

This definition of “variety” was further clarified by Agency guidance in the Benefits Redemption Division Policy Memorandum 01-04, titled, “Implementation of Final Retail Store Eligibility Rule” which was issued on August 14, 2001. This 2001 memorandum states that: “Examples of unacceptable varieties includes tomato juice, fresh tomatoes and canned stewed tomatoes in the vegetables or fruits category.”

Since the establishment of SNAP Criterion A, Agency policy has not considered multiple formats of a product ( e.g., raw chicken, canned chicken, and frozen chicken) to constitute discrete staple food varieties. Variety has been traditionally defined by the Agency based on the essential composition of the food product ( i.e., main ingredient), especially in the meat, poultry, or fish and vegetables or fruits staple food categories. Main ingredient has generally been determined by a product's first listed ingredient in the ingredients list on the product's Nutrition Facts label, as ingredients on the label are required to be listed from highest to lowest quantity by weight. For example, a can of tomato soup with a first listed ingredient of “tomatoes” in its ingredients list has a main ingredient of tomatoes, as that is the ingredient which occurs in the highest quantity in the soup, by weight; such a product has historically been considered a “tomato” variety in the vegetables or fruits staple food category. In the dairy products and bread or cereals staple food category, most staple foods share the same main ingredients ( e.g., cow milk for dairy and wheat for bread or cereals); therefore, product kind ( e.g., yogurt for dairy and bagels for bread or cereals) is used to define variety in conjunction with main ingredient. When determining variety in these two categories, FNS first considers main ingredient and then product kind. For example, a package of butter has a main ingredient of “cow milk” and is therefore a dairy product. However, FNS classifies this product as a “cow milk-based butter” staple food variety according to its identifiable product kind (butter). Products that share the same primary component ( e.g., sliced turkey and ground turkey—turkey) and very similar kinds of products ( e.g., McIntosh apples and Empire apples—apples; mozzarella cheese and cheddar cheese—cheeses) were not generally considered to represent discrete varieties in their respective staple food categories under the 2001 final rule. Main ingredient and product kind have, therefore, been recognized in Agency policy as the primary determinants of variety since the implementation of the 2001 final rule.

FNS proposed to modify Criterion A eligibility requirements in a Notice of Proposed Rulemaking (NPRM) titled “Enhancing Retailer Standards in the SNAP” which was published on February 17, 2016 (81 FR 8015). This 2016 NPRM sought to implement changes required by the 2014 Farm Bill and codify discretionary provisions under existing authority in the Food and Nutrition Act.

The “Definition of `Retail Food Store'—Breadth of Stock” provision of the 2016 NPRM proposed to increase the number of varieties required in each staple food category from three (3) to seven (7) and to increase the number of categories required to contain at least one (1) variety of perishable staple foods from two (2) to three (3). These increases were statutorily mandated by the 2014 Farm Bill, and were supported by a majority of commenters.

The “Definition of `Staple Food'—Acceptable Varieties in the Four Staple Food Categories” provision of the 2016 NPRM proposed to further clarify existing language at 7 CFR 278.1(b)(1)(ii)(C) that defines “variety” for the purposes of SNAP Criterion A eligibility by adding additional examples of food items considered to be acceptable staple food varieties. After the publication of the 2016 NPRM, FNS received a high volume of questions and interest from a wide range of stakeholders. Some of these questions centered on the definition of “variety” and inquired about other food items considered to be staple food varieties. On April 5, 2016, FNS published a clarification of the proposed rule and 30-day extension of the comment period at 81 FR 19500. In this 2016 clarification and extension, FNS indicated a specific interest in public feedback on the subject of the definition of “variety”, stating that: “FNS is particularly interested in comments from the public as to whether and how variety should take into account the differences between products within staple food categories (generally and individually), and what factors should be considered when making such distinctions.”

Of the total 1,260 germane and non-duplicative public comments received on both the 2016 NPRM and the subsequent clarification, 168 comments, or approximately 13% of all public comments, specifically addressed this provision. About 16% of total retailer commenters specifically opposed this provision. Food industry groups largely opposed this provision and other commenter types, such as advocacy, medical, and governmental entities, were generally divided and/or expressed mixed opinions. Of those that opposed the provision, some indicated that small format stores would struggle to reach seven (7) varieties in the meat, poultry, or fish and dairy products staple food categories and such commenters suggested increasing flexibility for stores in these categories. Such commenters suggested including plant-based proteins in the meat, poultry, or fish staple food category and plant-based dairy alternatives in the dairy products staple food category.

After carefully considering the public comments that were received, FNS published the final rule titled “Enhancing Retailer Standards in the SNAP” on December 15, 2016 (81 FR 90675). The “Definition of `Retail Food Store'—Breadth of Stock” provision was published in this 2016 final rule as proposed as this was a change mandated by the 2014 Farm Bill.

The “Definition of `Staple Food'—Acceptable Varieties in the Four Staple Food Categories” provision, however, was published with substantial modifications in the 2016 final rule. These modifications were made in response to public feedback received and were intended to provide retail food stores with a greater degree of flexibility in reaching the new breadth of stock required of certain retailers under SNAP Criterion A, especially in the meat, poultry, or fish and dairy products staple food categories.

Commenters who responded adversely to the definition of “variety” as it appeared in the 2016 NPRM generally focused on the difficulties small format retailers would have in reaching seven (7) varieties in the meat, poultry or fish and the dairy products staple food category. This concern was born out by the Agency's final Regulatory Flexibility Analysis which analyzed data from a nationally-representative sample of 1,392 SNAP authorized small format retail food stores and indicated that about 93% of currently SNAP authorized small stores already stocked enough varieties of vegetables or fruits and about 78% of these stores already stocked enough bread or cereals, while only about 46% of these stores already stocked enough meat, poultry, or fish and only about 27% of these stores already stocked enough dairy products. For this reason, FNS focused on providing more flexibility in the latter two staple food categories through the inclusion of plant-based protein sources in the meat, poultry, or fish staple food category, and the inclusion of plant-based dairy alternatives as well as additional dairy flexibilities in the dairy products staple food category.

The 2016 final rule allowed for the counting of plant-based protein sources as varieties in the meat, poultry, or fish staple food category. Specifically, this meant that beans, peas, and nuts/seeds could each individually be counted once in either the vegetables or fruits staple food category, or once in the meat, poultry, or fish staple food category. In addition, plant-based meat analogues, such as tofu and seitan, were added to the meat, poultry, or fish staple food category. These changes were made, consistent with USDA's MyPlate nutrition guidelines, to allow retailers more flexibility in stocking a sufficient number of varieties in the meat, poultry, or fish staple food category, and to help to ensure that SNAP households would have access to an array of healthy food options that meet diverse dietary needs and preferences. FNS is not proposing to modify or affect this change in this proposed rule and it will remain in place as it appeared in the 2016 final rule.

The 2016 final rule allowed for the counting of plant-based dairy alternatives as varieties in the dairy products staple food category. Specifically this meant that plant-based dairy products would be considered a variety in the dairy products staple food category based on their main ingredient and the traditional dairy product for which they are a substitute. So, for example, soy-based milk substitute, almond-based milk substitute, rice-based milk substitute, soy-based cheese substitute, almond-based cheese substitute, rice-based cheese substitute, soy-based yogurt substitute, almond-based yogurt substitute, and rice-based yogurt substitute would each be considered a discrete variety in the dairy products staple food category under the 2016 final rule. Though these items are plant-based, they are recognized as dairy equivalents and, therefore, would not count as varieties in the remaining staple food categories under the 2016 final rule. These changes were made in keeping with USDA's MyPlate nutrition guidelines, to allow retailers more flexibility in stocking a sufficient number of varieties in the dairy products category, and to help to ensure that SNAP households will have access to an array of healthy food options that meet diverse dietary needs and preferences. FNS is not proposing to modify or affect this change in this proposed rule and it will remain in place as it appeared in the 2016 final rule.

The 2016 final rule modified existing Agency policy to subdivide certain traditional, cow milk-based dairy varieties into more than one variety. For example, under the 2001 final rule, cheese was considered one variety while under the 2016 final rule, cow milk-based soft cheese and cow milk-based firm/hard cheese each were considered discrete varieties. Additionally, under the 2016 final rule, shelf-stable liquid cow milk ( e.g., evaporated or condensed milk), perishable liquid cow milk, and shelf-stable powdered cow milk would each be considered discrete varieties in the dairy products staple food category. Finally, under the 2016 final rule, cow milk-based yogurt and cow milk-based kefir (a yogurt drink) would each be considered discrete varieties in the dairy products staple food category. These changes were made in order to allow retailers more flexibility in stocking a sufficient number of traditional varieties in the dairy products category. This proposed rule would modify these changes, as discussed later in this document, in order to provide further flexibility in the dairy products staple food category.

Included below are two (2) tables that demonstrate completely different ways a retail food store could reach the required seven (7) varieties in each of the four staple food categories using the definition of “variety” as it appeared in the 2016 final rule. These are just examples of two (2) combinations that would satisfy the requirements in the 2016 final rule. These charts do not include all of the acceptable varieties or possible combinations of varieties. Additional examples of acceptable varieties in the four staple food categories are available in the “List of Examples” section of the 2016 final rule.

On May 5, 2017, the Consolidated Appropriations Act of 2017 was signed into law. Sec. 765 of the Consolidated Appropriations Acts of 2017 and thereafter the Consolidated Appropriations Act of 2018, prohibit the USDA from implementing the “Definition of `Staple Food'—Acceptable Varieties in the Four Staple Food Categories” provision (7 CFR 271.2 and 7 CFR 278.1(b)(1)(ii)(C)) and the “Definition of `Retail Food Store'—Breadth of Stock” provision (7 CFR 271.2 and 7 CFR 278.1(b)(1)(ii)(A)) of the 2016 final rule until the USDA promulgates regulatory amendments that modify the “Definition of `Staple Food'—Acceptable Varieties in the Four Staple Food Categories” provision of the 2016 final rule. Such regulatory amendments, moreover, must increase the number of items that qualify as acceptable varieties in each staple food category.

Using existing authority in the Food and Nutrition Act of 2008, as amended, FNS proposes to make changes to regulations at 7 CFR 271.2 and 7 CFR 278.1(b)(1)(ii)(C) to modify the definition of the term “variety” as it pertains to the stocking requirements for certain SNAP authorized retail food stores in order to increase the number of items that qualify as acceptable varieties in the four staple food categories, especially in the meat, poultry or fish, dairy, and breads or cereals staple food categories. These changes would provide retailers with more flexibility in meeting the enhanced SNAP eligibility requirements and meet the requirements expressed in the Consolidated Appropriations Acts of 2017 and 2018.

Together the changes proposed below add five (5) or more additional, discrete varieties in the meat, poultry, or fish, dairy, and bread or cereals staple food category, and provide five (5) more illustrative examples in the vegetables or fruits staple food category. Additionally, the current proposed rule will retain the changes in the 2016 final rule that provided flexibility regarding plant-based protein sources and plant-based dairy alternatives. Those flexibilities would remain in place as they appeared in the 2016 final rule. In conjunction with the twenty (20) discrete varieties identified in the “List of Examples” in the 2016 final rule, the proposed changes to the definition of “variety” would provide stores with a wide range of options in meeting stocking requirements in all four staple food categories.

FNS is also proposing to add an official definition of “variety” to the General Information and Definitions section of SNAP regulations found at 7 CFR 271.2 in order to convey that variety is intended to signify main ingredient or product kind. The inclusion of this definition codifies existing Agency practice which dictates which food items are considered to be staple food varieties. FNS considers the inclusion of this definition to be paramount to a clear understanding of the term “variety” in the context of SNAP retailer eligibility and the proposed changes in this rulemaking. This proposed rule would not modify any other provisions or components of the 2016 final rule.

Proposed changes made to the definition of “variety” are expected to have significant effects upon the SNAP retailer authorization process. Below are the strategies FNS is proposing to modify the definition of “variety” and provide retail food stores with more flexibility. FNS welcomes comments that specifically address these proposed changes as well as comments that offer other possible strategies for providing retailers with more flexibility while ensuring SNAP recipients have access to a range of healthful options at SNAP authorized retail food stores. FNS encourages commenters to include comments discussing the practicality and rationality of any suggested changes, as well as the nutritional and industry impact of these changes.

Under the 2016 final rule, “variety” was generally defined by product kind or main ingredient in the meat, poultry, or fish staple food category. This meant that chicken, pork, and beef were each considered discrete varieties. This also meant that, under the 2016 final rule, canned chicken and frozen chicken were not each considered discrete varieties. The Department is proposing a change with this rule that would allow any species of meat, poultry, or fish to be counted once as a discrete variety, if perishable, and once as a discrete variety, if shelf-stable.

Per SNAP regulations at 7 CFR 278.1(b)(1)(ii)(B), “perishable foods” are items which are frozen, refrigerated, or fresh staple food items that would spoil or suffer significant deterioration in quality within three weeks if stored at room temperature. An example of a perishable food in the meat, poultry, or fish staple food category is a raw salmon filet. “Shelf-stable foods” are items which are dried, pickled, smoked, or otherwise preserved, and stored in cans, jars, or other packaging that do not require refrigeration and would not spoil or suffer significant deterioration in quality within three weeks if the packaging remains unopened. An example of a shelf-stable food in the meat, poultry, or fish staple food category is a tin of sardines that requires no refrigeration.

To reach the required seven (7) varieties in the meat, poultry, or fish staple food category under this change, for example, a store could stock the following:

This is just an illustrative list and not meant to be exhaustive. This proposed change to the definition of “variety” would provide considerable additional flexibility in the meat, poultry, or fish staple food category, as this change would effectively double the number of available varieties in this category, where a staple food is available in both perishable and non-perishable forms.

Under the 2016 final rule, one specific traditional dairy product (cow milk-based cheese) was subdivided into two varieties ( i.e., soft cheese and hard/firm cheese) in order to provide more flexibility for stores in meeting the required seven (7) varieties in the dairy staple food category. The Department is proposing a change with this rule that would further subdivide cow milk-based cheese into four discrete varieties in the dairy products staple food category. The proposed subdivision of cow milk-based cheese would include the following four varieties and would be mirrored for other animal milk-based cheeses ( e.g., goat milk-based cheese):

1. Fresh cow milk-based cheeses ( e.g., cream cheese, cottage cheese, and ricotta cheese) are creamy, spreadable, and perishable dairy products.

2. Soft and semi-soft cow milk-based cheeses ( e.g., mozzarella cheese, Munster cheese, and brie cheese) are moist, slightly cured, and perishable dairy products.

3. Hard, firm, semi-hard, or medium-hard cow milk-based cheeses ( e.g., cheddar cheese, Swiss cheese, and Parmesan cheese) are less moist and more cured dairy products.

4. Cow milk-based cheese products and cow milk-based cheese- or dairy-based sauces, spreads, or dips ( e.g., canned spray cheese sauce, canned cheese dipping sauce, jarred Alfredo pasta sauce, and American cheese slices) are processed, often shelf-stable dairy products that have a dairy main ingredient ( e.g., milk or whey).

With this change, a store could stock four discrete varieties of cow milk-based cheese (fresh cheese, soft cheese, hard cheese, and cheese product). This change to the definition of “variety” would, therefore, provide an additional two cheese varieties for each type of animal milk-based cheese in the dairy products staple food category.

Under the 2016 final rule, one specific traditional dairy product (cow milk) was subdivided into three varieties (perishable cow milk, liquid shelf-stable cow milk, and powdered cow milk) in order to provide more flexibility for stores in meeting the required seven (7) varieties in the dairy staple food category. The Department is proposing a change with this rule that would further subdivide traditional dairy milk (cow milk) into four discrete varieties in the dairy products staple food category. The proposed subdivision of cow milk would include the following four varieties and would be mirrored for other animal milks ( e.g., goat milk):

1. Full-fat cow milks ( e.g., whole milk, cream, and half-and-half) are liquid, perishable cow milk products with 3% or greater fat content.

2. Fat-reduced cow milks ( e.g., 2% milk, 1% milk, skim milk, and other low-fat and non-fat milks) are liquid, perishable cow milk products with less than 3% fat content.

3. Liquid shelf-stable cow milks ( e.g., long-life milk, evaporated milk, and condensed milk) are cow milk products that have been processed and sealed in cans or cartons to render them shelf-stable.

4. Powdered cow milks ( e.g., dried milk, whey powder, and casein powder) are cow milk products that have been processed and dehydrated to render them shelf-stable.

With this change, a store could stock four discrete varieties of cow milk products (full-fat cow milk, fat-reduced cow milk, liquid shelf-stable cow milk, and powdered cow milk). This change to the definition of “variety” would, therefore, provide an additional variety in the dairy products staple food category for each type of animal milk in the dairy products staple food category. As noted earlier, the plant-based dairy alternatives proposed in the 2016 final rule—such as almond-based and soy-based milk substitutes—would remain unchanged in this proposed rule, and thus would also provide retailers with additional stocking options in this category.

Under the 2016 final rule one specific traditional dairy product (cow milk-based yogurt) was subdivided into two varieties (cow milk-based yogurt and perishable cow milk-based kefir) in order to provide more flexibility for stores in meeting the required seven (7) varieties in the dairy staple food category. The Department is proposing a change with this rule that would replace “perishable cow milk-based kefir” with cow milk-based yogurt drinks, to include other general yogurt-based drinks such as lassi and probiotic cultured milk smoothies. In addition, the Department is proposing to further subdivide “cow milk-based yogurt” into two distinct varieties and to mirror this subdivision in other animal milk-based yogurts ( e.g., goat milk-based yogurt). Thus, these proposed changes to the definition of variety would provide an additional variety in the dairy products staple food category for each type of animal milk-based yogurt. The proposed subdivision of cow milk-based yogurt would include the following three varieties:

1. Cow milk-based yogurt drinks ( e.g., lassi, kefir, and probiotic cultured milk smoothie) are liquid cow milk-based yogurt beverages that have cultured milk or yogurt as a main ingredient.

2. Full-fat cow milk-based yogurts ( e.g., strawberry full-fat yogurt, vanilla full-fat yogurt, and plain full-fat yogurt) are fermented semi-solid food products made from cow milk with 3% or greater fat content.

3. Fat-reduced cow milk-based yogurts ( e.g., strawberry low-fat yogurt, vanilla non-fat yogurt, and plain non-fat yogurt) are fermented semi-solid food products made from cow milk with less than 3% fat content.

To reach the required seven (7) varieties in the dairy products food category under this change, for example, a store could stock the following:

Under the 2016 final rule, FNS generally considered each distinct vegetable or fruit plant ( e.g., lettuce, collard greens, kale, etc.) to be a discrete staple food variety. As such, twenty (20) examples of fruits or vegetables, all considered to be acceptable varieties in the vegetables or fruits staple food category, were provided in the “List of Examples” section. This list was not intended to be comprehensive, as the number of distinct vegetable and fruit plants is considerable. Accordingly, the 2016 final rule provided numerous stocking options in meeting requirements in the vegetables or fruits staple food category, as evidenced by the 93% of currently authorized small format retailers who already meet requirements under the definition of variety provided in the 2016 final rule.

This proposed rule would maintain the definition of variety as outlined in the 2016 final rule as it pertains to acceptable varieties in the fruits or vegetables staple food category, with no proposed changes at this time. In attempting to identify additional, new staple food varieties in the category, FNS was unable to identify any additional edible vegetable or fruit which was not already considered to be a discrete staple food variety under the 2016 final rule. Further, all attempts to subdivide existing vegetable or fruit staple food varieties were problematic in that they clearly favored those vegetables or fruits which are more distinctly divisible.

That said, FNS recognizes that additional guidance on the numerous stocking options available in this category may be necessary. Thus, in addition to the further explanation provided above, included below are an additional five (5) varieties that are also considered acceptable varieties in the vegetables or fruits staple food category. These five (5) examples of acceptable varieties did not appear in the 2016 final rule “List of Examples” section:

Under the 2016 final rule, the staple food variety “wheat-based bread” was subdivided into five discrete staple food varieties in the bread or cereals staple food category (wheat-based bread, wheat-based bagels, wheat-based buns/rolls, wheat-based English muffins, and wheat-based pitas) in order to provide more flexibility for stores in meeting the required seven (7) varieties in the bread or cereals staple food category. The Department is proposing a change with this rule that would further subdivide the “wheat-based bread” staple food variety by adding the following three discrete staple food varieties in addition to the five varieties listed above: Wheat-based Indian flatbread, wheat-based crescent bread, and wheat-based matzah. This subdivision would be mirrored for other grain-based breads such as oats-based breads and rice-based breads. Thus, the proposed change to the definition of “variety” would provide three additional staple food varieties in the bread or cereals products staple food category for each type of grain-based bread. Under the proposed changes, the following eight would be considered discrete staple food varieties in the bread or cereals staple food category:

In order to provide cotton warehouse operators the flexibility to address real-time scheduling changes and market demands faced by cotton merchants and shippers, CCC would use a two-week rolling average of BMAS to determine a warehouse operator's compliance with the minimum cotton flow rate of 4.5% of applicable storage capacity.

For example, a cotton warehouse operator has scheduled 4.5% of the warehouse's applicable storage capacity to be available for shipment for several consecutive weeks. The week before a load is scheduled to be picked-up, a shipper requests to change its load out date to an earlier load out date in the preceding week, for an amount representing 0.25% of the warehouse's applicable storage capacity. If the warehouse operator has that specific load (0.25% of licensed capacity) already staged for a scheduled delivery the following week, that load could be picked up earlier, in the week preceding the original load out date. Without using a two-week rolling average and without making any additional bale adjustments, the warehouse operator would be considered to have delivered cotton without unnecessary delay for the first week because its BMAS is 4.75%, which is greater than the required 4.5%. However, the warehouse operator would not be considered to have delivered cotton without unnecessary delay during the second week because its BMAS is 4.25%, which is less than he required 4.5%. In this example, the option to calculate BMAS compliance using the rolling average of the reporting week and the week preceding the reporting week would result in a determination by CCC that the cotton warehouse operator is in compliance with a BMAS of 4.5% for the reporting week.

In another example, one that illustrates the third option of meeting the cotton flow requirement, a cotton warehouse operator schedules 4.5% of the applicable storage capacity for delivery in each of three consecutive weeks. During the first week, the cotton warehouse operator actually makes available for shipment 6.0% of the applicable storage capacity. During the second week, the cotton warehouse operator only makes 2.0% of applicable storage capacity available for shipment. During the third week, the cotton warehouse operator makes 7.0% of applicable storage capacity available for shipment. In this example, the cotton warehouse operator is considered to have delivered cotton without unnecessary delay during the first and the third weeks. During the second week however, the CCC will use the two-week rolling average of either the applicable week and the immediately preceding week, which results in an average BMAS of 4.0%, or the two-week rolling average of the applicable week and the immediately succeeding week, which results in an average BMAS of 4.5% to make its compliance determination for the second week. Using the two-week rolling average of the second and third week to calculate the BMAS for the second week allows the CCC to consider the cotton warehouse operator to have delivered cotton without unnecessary delay for that second week because the 4.5% average met the cotton flow requirement.

This proposed rule change would continue to require warehouse operators to report their BMAS each week based upon the revised definition of BMAS. CCC would determine compliance on an individual reporting week, or if needed, use an option of one of the rolling average calculations of BMAS for two consecutive reporting weeks. In the event that CCC uses the average of the applicable week and the immediately succeeding week, CCC would determine compliance for the applicable week after it receives the data from the immediately succeeding week. These options would allow cotton warehouse operators to meet the cotton flow requirements of the regulation while being flexible to the needs of the shipping and merchant industries.

This rule does not meet the definition of a significant regulatory action contained in section 3(f) of Executive Order 12866 and is not subject to review by the Office of Management and Budget (OMB). Additionally, because this rule does not meet the definition of a significant regulatory action it does not trigger the requirements contained in Executive Order 13771. See OMB's Memorandum titled “Interim Guidance Implementing Section 2 of the Executive Order of January 30, 2017, titled `Reducing Regulation and Controlling Regulatory Costs' ” (February 2, 2017).

Pursuant to the requirements set forth in the Regulatory Flexibility Act (RFA) [5 U.S.C. 601 et seq. ], CCC has considered the economic effect of this action on small entities and has determined that this proposed rule would not have a significant economic impact on a substantial number of small business entities. 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 burdened.

Currently, there are 326 CCC-approved warehouses that store cotton. The U.S. Small Business Administration's Table of Small Business Size Standards matched to the North American Industry Classification System (NAICS) Codes identifies small business size by average annual receipts or by the average number of employees at a firm. This information can be found at 13 CFR parts 121.104, 121.106, and 121.201. CCC estimates that 50 CCC-approved warehouses that store cotton would be considered small businesses according to SBA standards.

Sizes of cotton warehouses vary in size as well as business type, including small, independent country warehouses, small to large sized warehouses owned by cooperatives of producers, and small to large sized warehouses owned by corporate shippers/merchants. The effects of this proposed rule are not expected to be disproportionately greater or lesser for small businesses than for large businesses.

USDA is committed to complying with the E-Government Act of 2002 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. Accordingly, CCC developed options for companies requesting service to do so electronically.

This action has been reviewed in accordance with the requirements of Executive Order 13175, Consultation and Coordination with Indian Tribal Governments. The review reveals that this regulation would not have substantial and direct effects on Tribal governments and would not have significant Tribal implications.

This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. This proposed rule is not intended to have retroactive effect. The USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this proposed rule.

The warehouse operator may resolve any claim for noncompliance from any entity, such as a merchant or shipper, other than CCC with the cotton shipping standard in a court of competent jurisdiction or through mutually agreed upon arbitration procedures. CCC does not have authority to limit an entity from filing suit in a court of law against another entity.

The warehouse operator may request that CCC reconsider adverse actions when the warehouse operator establishes that the reasons for the action have been remedied or requests reconsideration of the action.

The cotton information covered in this proposed rule is the weekly reporting of BMAS by cotton warehouses. BMAS is reported through the Electronic Warehouse Receipt Inc. (EWR Inc.) system, to which AMS has access. EWR Inc. is a USDA licensed provider company and generally contains information that is exempt from the Paperwork Reduction Act (44 U.S.C. Chapter 35) because it is usual and customary business information. The proposed change in the regulation would not change the burden associated with reporting BMAS, which is required to be reported weekly.

AMS administers the CCC-approved warehouse program for CCC. This responsibility includes entering into contracts for the storage and handling of CCC-interest commodities with warehouses. The operators of those approved warehouses are required to comply with CCC regulations, which include reporting information about the stored commodities to CCC. The specific requirements that operators of approved warehouses must meet are specified in the regulations at § 7 CFR 1423 “Commodity Credit Corporation Approved Warehouses” and in the signed storage agreement between CCC and the warehouse operator for each type of commodity.

Operators of CCC-approved cotton warehouses are currently required to report BMAS, among other data, to the CCC on a weekly basis. Under the current rule at § 7 CFR 1423.11(b)(1)(ii), bales that were scheduled and ready for delivery in a previous week, but not picked up by the shipper, remained available for loading and for which another shipping date had not been established could be counted toward BMAS for up to two weeks. This proposed rule would clarify that bales scheduled and ready for delivery during a week but not picked up by the end of that reporting week can only be reported as BMAS for that one week that such bales were made available for shipment. The National Cotton Council, on behalf of the U.S. cotton industry, requested this change in order to increase the cotton flow rate to domestic and foreign manufacturers, to more quickly respond to domestic and international market needs, and to optimize performance by approved cotton warehouse operators. This change is being made to simplify the calculation of BMAS so that certain bales do not need to be accounted for beyond the applicable reporting week. The proposed rule would change how BNPU are counted in the weekly report to CCC. It would not change any warehouse tariffs or fees.

A conforming change would also be made to CCC's Cotton Storage Agreement (Form CCC-823). The storage agreement is the agreement between CCC and the cotton warehouse operator on the requirements that the warehouse operator must meet for storing and handling CCC-interest cotton. The standard cotton storage agreement form and the subsequent amendments are available on the USDA website at: https://forms.sc.egov.usda.gov//efcommon/eFileServices/eForms/CCC823.PDF .

There is no expected cost to warehouses or CCC of reporting BMAS as specified in this proposed rule. The proposed rule would only change how bales made available but not picked up by the shipper or merchant are reported by the warehouse operator to CCC in the weekly report. It does not change warehouse tariffs or restocking fees.

This change is intended to improve the efficiency of cotton flow from U.S. producers and cotton warehouses to shippers, and ultimately to cotton manufacturers, by more accurately reporting cotton that is available for shipment. Under the current rule, it has become apparent that certain bales may have been scheduled and ready for shipment but were never picked up for two weeks or more, potentially inflating BMAS calculations. This proposed rule change is meant to more accurately reflect how the cotton industry actually makes bales available for shipment during that one week. Availability and consistent supply of cotton are crucial for the U.S. cotton industry in order to compete with other cotton producing nations and having accurate information about bales made available for shipment contributes to more efficient and effective marketing of U.S. cotton.

For the reasons stated in the preamble, the Commodity Credit Corporation proposes to amend 7 CFR part 1423 as follows:

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

This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General Requirements.” Under that section, the FAA is charged with promoting safe flight of civil aircraft in air commerce by prescribing regulations and minimum standards for the design and performance of aircraft that the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority. It prescribes new, relieving, safety standards for the design and operation of transport category airplanes.

The FAA proposes to amend title 14, Code of Federal Regulations (14 CFR) part 25. Specifically, the FAA proposes to amend §§ 25.841, “Pressurized cabins,” and 25.1447, “Equipment standards for oxygen dispensing units,” for airplanes equipped with cabin pressurization systems and oxygen dispensing equipment intended for operations into or out of airports with elevations at or above 8,000 feet, also referred to as “high elevation airports.”

The proposed amendments to § 25.841 would eliminate the burden on industry and the FAA that results from project-specific ELOS findings currently necessary for the FAA to approve such designs for cabin pressurization systems intended to be used for operations into or out of high elevation airports.

Section 25.841(a) limits the cabin pressure altitude to not more than 8,000 feet at the maximum operating altitude of the airplane under normal operating conditions. Operating at the maximum operating altitude of the airplane is considered a normal operating condition. Section 25.841(a) was never intended to imply that the cabin pressure altitude could exceed 8,000 feet under normal operating conditions provided the airplane was below the maximum operating altitude. Accordingly, the FAA proposes to revise § 25.841(a) to clarify the limit on cabin pressure altitude to not more than 8,000 feet under normal operating conditions. This revision is not necessary for the other changes being proposed for operations into and out of high elevation airport operations, but since it is related, FAA is making this clarification here.

The cabin pressure altitude requirement in § 25.841(a) does not allow certification of airplane designs that can safely accommodate operations into or out of high elevation airports. The FAA proposes adding § 25.841(c) as an exception to § 25.841(a) to accommodate operations into or out of high elevation airports. Proposed § 25.841(c) would allow the cabin pressure in pressurized cabins and occupied compartments to be equal to or less than the airport elevation while the airplane operates at or below 25,000 feet, provided the cabin pressurization system is designed to minimize the time that passenger cabin occupants would be exposed to cabin pressures exceeding 8,000 feet in flight.

Section 25.841(b)(6) requires a warning indication at the pilot or flight engineer station to indicate when the safe or preset cabin pressure altitude limit is exceeded to alert the flightcrew to potential hypoxic conditions. Section 25.841(b)(6) also states that this warning requirement for cabin pressure altitude limits is met if it warns the flightcrew when the cabin pressure altitude exceeds 10,000 feet. The FAA proposes adding new § 25.841(d) as an exception to § 25.841(b)(6) to allow an applicant to change the cabin altitude warning to 15,000 feet or 2,000 feet above the airport elevation, whichever is greater, when operating into or out of a high elevation airport.

Further, § 25.1447(c)(1) requires that airplanes being certified for operation above 30,000 feet must be equipped with oxygen dispensing units providing the required oxygen flow, and that such units must be automatically presented to the occupant before the cabin pressure exceeds 15,000 feet above sea level. Section 25.1447(c)(1) also states the crew must be provided with a manual means to make the dispensing units immediately available in the event of failure of the automatic system. This proposal would add § 25.1447(c)(5) as an exception to § 25.1447(c)(1) to allow approval of passenger cabin oxygen dispensing units that automatically deploy at 15,000 feet, or 2,000 feet above the airport elevation, whichever is greater, during operations into or out of high elevation airports. This proposed action would relieve industry from having to petition, and the FAA from the burden of evaluating and granting applicant-specific exemptions from § 25.1447(c)(1), currently necessary to increase the cabin pressure at which passenger cabin oxygen dispensing unties automatically deploy.

Cabin pressurization systems of airplanes are typically designed to maintain the interior cabin pressure so that the maximum cabin pressure altitude does not exceed 8,000 feet and to ensure that the change in cabin pressure altitude is minimized during flight. While an airplane is on the ground, the interior cabin pressure must be equal to the outside ambient air pressure to allow for easy opening of the exit doors should there be a need for an emergency evacuation. When an airplane ascends, its cabin pressure altitude starts at the equivalent altitude of the airport and slowly changes as the airplane climbs until the cabin pressure altitude is stabilized at an altitude not exceeding 8,000 feet, which is the current regulatory maximum cabin pressure altitude allowable. However, when an airplane takes off from an airport with an elevation greater than 8,000 feet, the cabin pressure altitude must begin at that higher equivalent altitude and slowly decrease until it is less than 8,000 feet. Similarly, when an airplane is configured to land at a high elevation airport, the interior cabin pressure altitude will start near 8,000 feet and slowly rise as the airplane descends into the airport, until the interior cabin pressure altitude is the same as the equivalent pressure altitude at the airport when the airplane lands. Since the maximum cabin pressure altitude of 8,000 feet is exceeded when operating into or out of high elevation airports, the airplane is out of compliance with 14 CFR 25.841.

Globally, there are several airports at elevations that exceed 14,000 feet. An example of a high elevation airport is Daocheng Yading Airport, in Tibet, at 14,472 feet.

To accommodate high elevation airport operations, applicants for type certificates incorporate design features for the cabin pressurization system that are intended to minimize the time that the cabin pressure altitude is above 8,000 feet. If a cabin altitude warning is set at 10,000 feet, for example, the flightcrew may receive nuisance warnings during high elevation airport takeoff and landing operations, unless special design features are incorporated. Accordingly, airplane manufacturers typically design the cabin pressurization control system to raise the cabin pressure altitude at which the warning occurs during these high elevation airport operations.

Currently, when an airplane manufacturer applies for certification of an airplane with a cabin pressurization system intended to be used for operations into or out of high elevation airports, the cabin pressurization system does not meet the design standard in § 25.841(a) and (b)(6) and the FAA must make an ELOS finding, if appropriate. An ELOS finding is made when the design does not comply with the applicable airworthiness provisions, but compensating factors provide an equivalent level of safety. 1 For the design standard provided by § 25.841(a) and (b)(6), compensating factors such as the flight crew's use of supplemental oxygen and minimizing the time that the cabin pressure altitude may be above 8,000 feet, provide an equivalent level of safety during high elevation airport operations. The FAA documents an ELOS finding in an ELOS memorandum that communicates to the public the rationale for the FAA's determination of equivalency to the level of safety intended by the regulations. The ELOS memorandum also documents those aspects of the ELOS finding that must be maintained for continued airworthiness. Processing an ELOS request ( i.e., evaluating the request, making the finding, and creating the ELOS memorandum) creates an extra administrative burden on the applicant as well as the FAA during the aircraft certification process. 2 The FAA typically makes about four ELOS findings per year related to high elevation airport operations. For each ELOS finding related to high elevation airport operations, the FAA may spend 20 to 100 engineering hours, depending on how unique the proposed design features are, and whether or not the applicant has previously proposed airplane designs intended for such operations in the past. We estimate that applicants expend similar resources.

Section 25.1447(c)(1) requires that, for airplanes certified for operations above 30,000 feet, oxygen dispensing equipment be automatically deployed before the cabin pressure altitude reaches 15,000 feet. To prevent unnecessary deployments and avoid unnecessary maintenance costs associated with servicing the oxygen system on airplanes intended to operate at high elevation airports, applicants typically incorporate design features to raise the automatic presentation altitude for the oxygen masks during high elevation airport operations. Currently, applicants that incorporate these design features do so pursuant to an agency-issued exemption from § 25.1447(c)(1). 3 A petition for exemption for airplanes certified for operation above 30,000 feet into high elevation airports creates a burden for applicants who develop the petition as well as the FAA in the agency's evaluation and analysis of the petition. The FAA typically grants one or two exemptions per year related to high elevation airport operations. 4 For each exemption related to high elevation airport operations, the FAA may spend 20 to 100 engineering hours depending on how similar the specific exemption petition is in relation to those previously granted. In addition to expended resources, exemptions typically increase the time for certification because the FAA follows the procedures for public comment described in 14 CFR part 11 as appropriate. We expect that applicants expend similar resources.

The intent of § 25.841(a) is to maintain a safe pressure environment within the cabin during normal operations. Currently, § 25.841(a) limits the cabin pressure altitude to not more than 8,000 feet at the maximum operating altitude of the airplane under normal operating conditions. Operating at the maximum operating altitude of the airplane is considered a normal operating condition. Section 25.841(a) was never intended to imply that the cabin pressure altitude could exceed 8,000 feet under normal operating conditions provided the airplane was below the maximum operating altitude. The physiological effects associated with exposure to high cabin pressure altitudes, namely hypoxia, vary from one individual to the next as a function of altitude and time. Common effects associated with hypoxia include increased heart rate, decreased cognitive ability, nausea, and increased chance of cardiac arrest or stroke. These physiological effects are rare when the cabin pressure altitude does not exceed 8,000 feet. For clarity, the FAA proposes to revise § 25.841(a) to limit the cabin pressure altitude to not more than 8,000 feet under normal operating conditions even though this clarification is not necessary for the proposed changes for operations into and out of high elevation airport operations.

During normal operations into or out of high elevation airports, however, it is possible that the cabin pressure altitude will exceed 8,000 feet while the airplane is on the ground. When the airplane is on the ground with a higher pressure inside the passenger cabin compared to the outside air pressure, it could be difficult if not impossible to open the emergency exits depending on the design and magnitude of pressure differential. For example, landing at an airport that is at 10,000 feet while the passenger cabin is at 8,000 feet. This would impede emergency evacuation and decrease safety. Although some emergency exit designs may allow a cabin attendant to unlatch and start opening a door with a slight pressure differential, the door could quickly swing open and pull the attendant outside as the emergency escape slide is inflating, which would also impede evacuation efforts and endanger the flight attendant.

The FAA proposes adding § 25.841(c) as an exception to § 25.841(a), to accommodate operations into or out of high elevation airports. Proposed § 25.841(c) would allow the cabin pressure in pressurized cabins and occupied compartments to be equal to or less than the airport elevation while the airplane operates at or below 25,000 feet, provided the cabin pressurization system is designed to minimize the time that passenger cabin occupants would be exposed to cabin pressures exceeding 8,000 feet in flight. The exception to § 25.841(a) would only apply when the airplane is at or below 25,000 feet because the risk of hypoxia following a decompression increases with altitude. In addition, this will maintain consistency with other oxygen availability requirements that are not affected by this proposal. This proposed change would allow certification of airplane designs that can safely accommodate operations into or out of high elevation airports by minimizing the time that the cabin pressure may be above 8,000 feet without unnecessarily exposing occupants to high cabin pressures in the unlikely event of a pressurization failure.

The intent of the design requirement in current § 25.841(b)(6) is to provide the flightcrew with a warning when the safe or preset cabin pressure altitude limit is exceeded. Consistent with the proposed addition of § 25.841(c) to accommodate operations into high elevation airports and to reduce the possibility of exposure to high cabin pressures above 25,000 feet, if a failure condition (decompression) occurs, the FAA proposes adding § 25.841(d) as an exception to § 25.841(b)(6).

Proposed § 25.841(d) would allow an applicant to change the cabin altitude warning to 15,000 feet, or 2,000 feet above the airport elevation, whichever is greater, when operating into or out of airports exceeding 8,000 feet provided that—

1. The airplane is at or below 25,000 feet;

2. An alert is provided to clearly indicate to the flightcrew that the cabin high altitude warning has shifted above 10,000 feet;

3. If the cabin altitude warning alert shifts above 10,000 feet automatically, an alert is provided to notify the flightcrew to take action should the automatic shift function fail; and

4. Either an alerting system is installed to notify the flightcrew on flight deck duty when to don oxygen mask(s), in accordance with the applicable operating regulations; or a flight procedure acceptable to the FAA administrator is provided in the airplane flight manual requiring the pilot in command to don oxygen when the cabin warning has shifted above 10,000 feet and other flightcrew on flight deck duty to monitor cabin pressure and utilize supplemental oxygen, in accordance with the applicable operating regulations.

In addition, the potential risk of hypoxia by the flightcrew members following a decompression during high elevation airport operations is also minimized because the cabin pressure warning altitude can only be raised above 10,000 feet while the airplane is at or below 25,000 feet above sea level. Further, there are operational requirements, such as those at 14 CFR 91.211, 121.333, and 135.157, that describe when supplemental oxygen must be used for passengers, cabin crew, and flightcrew members on flight deck duty. The use of supplemental oxygen for airplane occupants is a function of altitude, time exposure, and flightcrew members duties anticipated on the airplane. (Such requirements are intended to minimize the symptoms of hypoxia for airplane occupants, but are not being proposed for revision by this notice.) Therefore, airplane designs that meet the requirements proposed in this NPRM would maintain an appropriate level of safety that is consistent with previously issued ELOS determinations.

Also, for commonality with other regulatory text, the FAA is proposing to clarify existing § 25.841(b)(6), which currently requires an aural or visual signal to warn the flightcrew when the cabin pressure altitude exceeds 10,000 feet, to simply require an alert rather than a specific additional aural or visual signal. At Amendment 25-131 (75 FR 67201, November 2, 2010), effective January 3, 2011, the FAA created § 25.1322 to add flightcrew alerting requirements. An alert designed in accordance with § 25.1322 would ensure an appropriate alerting is provided to the flightcrew without the need for a separate aural or visual alert standard in § 25.841(b)(6), which allows for more options in developing an appropriate alert.

The FAA proposes an exception to the passenger oxygen mask presentation requirement in current § 25.1447(c) to allow for presentation at higher altitudes when operating into high elevation airports. Section 25.1447(c) describes presentation requirements for passenger oxygen masks. In accordance with § 25.1447(c)(1), for airplanes certified for operation above 30,000 feet, oxygen masks providing the required oxygen flow must be automatically presented before the cabin pressure altitude exceeds 15,000 feet. Typical designs include oxygen mask storage doors located above the seats with electrically actuated latches. As electricity is supplied to the latches, the doors open and oxygen masks are made available. Electricity to the latches is typically provided through a pressure switch, which is either open or closed, depending on ambient pressure within the passenger cabin. Common pressure switches have a tolerance of ±500 feet, so it is possible for oxygen masks to be presented as low as 14,000 feet to ensure they are made available before the cabin pressure reaches 15,000 feet.

There are several airports throughout the world with elevations above 14,000 feet such that oxygen masks could be deployed when an airplane lands at or takes off from them. The FAA has granted numerous exemptions from the automatic presentation requirements in § 25.1447(c)(1) to accommodate such operations. 5 For each exemption petition, the FAA works with the applicant to ensure that an adequate level of safety is maintained for each system design. To eliminate the need for exemptions as more airports open in high elevation terrains or more airplanes are designed with the intent to operate into existing high elevation airports, the FAA proposes adding § 25.1447(c)(5) as an exception to § 25.1447(c)(1). Proposed § 25.1447(c)(5) would allow oxygen mask presentation at altitudes of up to 2,000 feet above the airport elevation to prevent the unnecessary deployment of oxygen masks.

The FAA recognizes that a sudden loss of cabin pressure could expose passengers and cabin crew to higher cabin pressure altitudes before oxygen masks are presented if the automatic presentation altitude is raised. To mitigate this risk, the proposed changes include limitations on the exception in that the automatic presentation altitude for the masks can only be raised when operating into or out of high elevation airports, and only when the airplane is at or below 25,000 feet.

As previously discussed, the proposed changes will not negatively affect safety during high elevation airport operations because of the limited portion of the operation during which the proposed change will apply and the measures already in place to ensure safety during emergency conditions. Additionally, these proposed changes are consistent with previously granted exemptions and ELOS determinations.

Changes to Federal regulations must undergo several economic analyses. First, Executive Order 12866 and Executive Order 13563 direct that each Federal agency shall propose or adopt a regulation only upon a reasoned determination that the benefits of the intended regulation justify its costs. Second, the Regulatory Flexibility Act of 1980 (Pub. L. 96-354) requires agencies to analyze the economic impact of regulatory changes on small entities. Third, the Trade Agreements Act (Pub. L. 96-39) prohibits agencies from setting standards that create unnecessary obstacles to the foreign commerce of the United States. In developing U.S. standards, the Trade Act requires agencies to consider international standards and, where appropriate, that they be the basis of U.S. standards. Fourth, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) requires agencies to prepare a written assessment of the costs, benefits, and other effects of proposed or final rules, which include a Federal mandate likely to result in the expenditure by State, local, or tribal governments, in the aggregate, or by the private sector, of $100 million or more annually (adjusted for inflation with base year of 1995). This portion of the preamble summarizes the FAA's analysis of the economic impacts of this proposed rule.

In conducting these analyses, FAA has determined that this proposed rule (1) has benefits that justify its costs; (2) is not an economically “significant regulatory action” as defined in section 3(f) of Executive Order 12866; (3) would not have a significant economic impact on a substantial number of small entities; (4) would not create unnecessary obstacles to the foreign commerce of the United States; and (5) would not impose an unfunded mandate on state, local, or tribal governments, or on the private sector by exceeding the threshold identified previously. These analyses are summarized below.

Currently, the FAA processes ELOS memorandums to document ELOS findings when an airplane manufacturer or modifier requests certification of airplane cabin pressurization systems used for operations into or out of airports with elevations at or above 8,000 feet. The FAA also processes exemptions to the automatic oxygen mask presentation requirements for operations into or out of airports with elevations at or above 14,000 feet. The proposed rule would eliminate the need to continue performing the administrative tasks and analyses associated with the processing of an ELOS or exemption to accommodate operations at high elevation airports for transport category airplanes without compromising safety.

This proposed rule would result in small quantifiable cost savings. As previously discussed, the FAA issues about four ELOS findings and up to two exemptions per year related to high elevation airports, involving 20 to 100 engineering hours for each ELOS or exemption project. The FAA estimates industry and the FAA may expend the same range of engineering hours for each ELOS and exemption project. Using an average aerospace engineer hourly wage of $65, the FAA estimates the total annual cost savings of this proposed rule would range from $15,600 to $78,000 for both industry and FAA. 6

As previously discussed, in addition to expended resources, exemptions typically increase the time for certification because the FAA follows procedures for public comment described in 14 CFR part 11 as appropriate. This proposed rule may reduce this time resulting in cost savings.

As a result, this rulemaking will reduce the cost of airplane certification without reducing the current level of safety. The expected outcome would be a minimal economic impact resulting in a small regulatory burden relief. The FAA requests comments with supporting justification about the FAA determination of minimal economic impact.

Therefore, the FAA has determined that this proposed rule is not a “significant regulatory action” as defined in section 3(f) of Executive Order 12866, and is not “significant” as defined in DOT's Regulatory Policies and Procedures.

The Regulatory Flexibility Act of 1980 (Pub. L. 96-354) (RFA) establishes “as a principle of regulatory issuance that agencies shall endeavor, consistent with the objectives of the rule and of applicable statutes, to fit regulatory and informational requirements to the scale of the businesses, organizations, and governmental jurisdictions subject to regulation.” To achieve this principle, agencies are required to solicit and consider flexible regulatory proposals and to explain the rationale for their actions to assure that such proposals are given serious consideration. The RFA potentially covers a wide-range of small entities, including small businesses, and not-for-profit organizations.

Agencies must perform a review to determine whether a rule will have a significant economic impact on a substantial number of small entities. If the agency determines that it will, the agency must prepare a regulatory flexibility analysis as described in the RFA.

However, if an agency determines that a rule is not expected to have a significant economic impact on a substantial number of small entities, section 605(b) of the RFA provides that the head of the agency may so certify and a regulatory flexibility analysis is not required. The certification must include a statement providing the factual basis for this determination, and the reasoning should be clear.

The proposed rule would relieve the industry from requesting that the FAA make a determination that an ELOS exists for certification of airplane cabin pressurization systems used for operations into or out of airports with elevations at or above 8,000 feet above sea level. This proposed rule would also relieve industry from petitioning for exemptions to the automatic oxygen mask presentation requirements for operations into and out of airports with elevations at or above 14,000 feet above sea level. The expected outcome would be a minimal economic impact with small burden relief and savings for any small entity affected by this rulemaking action.

If an agency determines that a rulemaking will not result in a significant economic impact on a substantial number of small entities, the head of the agency may so certify under section 605(b) of the RFA. Therefore, as provided in section 605(b), the head of the FAA certifies that this proposed rulemaking would not result in a significant economic impact on a substantial number of small entities.

The Trade Agreements Act of 1979 (Pub. L. 96-39), as amended by the Uruguay Round Agreements Act (Pub. L. 103-465), prohibits Federal agencies from establishing standards or engaging in related activities that create unnecessary obstacles to the foreign commerce of the United States. Pursuant to these Acts, the establishment of standards is not considered an unnecessary obstacle to the foreign commerce of the United States, so long as the standard has a legitimate domestic objective, such as the protection of safety, and does not operate in a manner that excludes imports that meet this objective. The statute also requires consideration of international standards and, where appropriate, that they be the basis for U.S. standards. The FAA has assessed the potential effect of this proposed rule and determined that it would have only a domestic impact and therefore no effect on international trade.

Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) requires each Federal agency to prepare a written statement assessing the effects of any Federal mandate in a proposed or final agency rule that may result in an expenditure of $100 million or more (in 1995 dollars) in any one year by State, local, and tribal governments, in the aggregate, or by the private sector. Such a mandate is deemed a “significant regulatory action.” The FAA currently uses an inflation-adjusted value of $155 million in lieu of $100 million. This proposed rule does not contain such a mandate; therefore, the requirements of Title II of the Act do not apply.

The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) requires that the FAA consider the impact of paperwork and other information collection burdens imposed on the public. The FAA has determined that there would be no new requirement for information collection associated with this proposed rule.

In keeping with U.S. obligations under the Convention on International Civil Aviation, it is FAA's policy to conform to International Civil Aviation Organization (ICAO) Standards and Recommended Practices to the maximum extent practicable. The FAA has reviewed the corresponding ICAO Standards and Recommended Practices and has found no differences with these proposed regulations.

EASA certification requirements related to oxygen dispensing units in CS25.1447(c)(1) are similar to those in § 25.1447(c)(1). In Amendment 18 of Certification Specifications and Acceptable Means of Compliance for Large Aeroplanes, CS-25, 7 the European Aviation Safety Agency (EASA) describes an acceptable means of compliance (AMC) in AMC 25.1447(c)(1). Specifically, AMC 25.1447(c)(1) states: “The design of the automatic presentation system should take into account that when the landing field altitude is less than 610 m (2000 feet) below the normal preset automatic presentation altitude, the automatic presentation altitude may be reset to landing field altitude plus 610 m (2000 feet).” Thus, the FAA's proposed change to § 25.1447 is consistent with guidance provided by EASA.

EASA has not published advisory material to accommodate operations into or out of high elevation airports in consideration of the cabin pressure altitude and warning requirements in CS 25.841.

FAA Order 1050.1F identifies FAA actions that are categorically excluded from preparation of an environmental assessment or environmental impact statement under the National Environmental Policy Act in the absence of extraordinary circumstances. The FAA has determined this rulemaking action qualifies for the categorical exclusion identified in paragraph 5-6.6 of FAA Order 1050.1F and involves no extraordinary circumstances.

The FAA has analyzed this proposed rule under the principles and criteria of Executive Order 13132, “Federalism.” The agency has determined that this action would not have a substantial direct effect on the States, or on the relationship between the Federal Government and the States, or on the distribution of power and responsibilities among the various levels of government, and, therefore, would not have Federalism implications.

The FAA analyzed this proposed rule under Executive Order 13211, “Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use” (May 18, 2001). The agency has determined that it would not be a “significant energy action” under the executive order and would not be likely to have a significant adverse effect on the supply, distribution, or use of energy.

Executive Order 13609, “Promoting International Regulatory Cooperation,” promotes international regulatory cooperation to meet shared challenges involving health, safety, labor, security, environmental, and other issues and to reduce, eliminate, or prevent unnecessary differences in regulatory requirements. The FAA has analyzed this action under the policies and agency responsibilities of Executive Order 13609, and has determined that this action would have no effect on international regulatory cooperation.

This proposed rule is expected to be an Executive Order 13771 deregulatory action. Details on the regulatory relief provided by this proposed rule can be found in the Regulatory Evaluation section.

The FAA invites interested persons to participate in this rulemaking by submitting written comments, data, or views. The agency also invites comments relating to the economic, environmental, energy, or federalism impacts that might result from adopting the proposals in this document. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. To ensure the docket does not contain duplicate comments, commenters should send only one copy of written comments, or if comments are filed electronically, commenters should submit only one time.

The FAA will file in the docket all comments it receives, as well as a report summarizing each substantive public contact with FAA personnel concerning this proposed rulemaking. Before acting on this proposal, the FAA will consider all comments it receives on or before the closing date for comments. The FAA will consider comments filed after the comment period has closed if it is possible to do so without incurring expense or delay. The agency may change this proposal in light of the comments it receives.

Proprietary or Confidential Business Information: Commenters should not file proprietary or confidential business information in the docket. Such information must be sent or delivered directly to the person identified in the FOR FURTHER INFORMATION CONTACT section of this document, and marked as proprietary or confidential. If submitting information on a disk or CD ROM, mark the outside of the disk or CD ROM, and identify electronically within the disk or CD ROM the specific information that is proprietary or confidential.

Under 14 CFR 11.35(b), if the FAA is aware of proprietary information filed with a comment, the agency does not place it in the docket. It is held in a separate file to which the public does not have access, and the FAA places a note in the docket that it has received it. If the FAA receives a request to examine or copy this information, it treats it as any other request under the Freedom of Information Act (5 U.S.C. 552). The FAA processes such a request under Department of Transportation procedures found in 49 CFR part 7.

An electronic copy of rulemaking documents may be obtained from the internet by—

1. Searching the Federal eRulemaking Portal ( http://www.regulations.gov );

2. Visiting the FAA's Regulations and Policies web page at http://www.faa.gov/regulations_policies or

3. Accessing the Government Printing Office's web page at http://www.gpo.gov/fdsys/.

Copies may also be obtained by sending a request to the Federal Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence Avenue SW, Washington, DC 20591, or by calling 202-267-9677. Commenters must identify the docket or notice number of this rulemaking.

All documents the FAA considered in developing this proposed rule, including economic analyses and technical reports, may be accessed from the internet through the Federal eRulemaking Portal referenced in item (1) above.

In consideration of the foregoing, the Federal Aviation Administration proposes to amend chapter I of title 14, Code of Federal Regulations as follows:

Comments Invited

We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2018-0240; Product Identifier 2018-CE-057-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD because of those comments.

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

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Community, has issued EASA AD No. 2018-0235, dated November 5, 2018 (referred to after this as “the MCAI”), to correct an unsafe condition for Pilatus Aircraft Limited Models PC-6, PC-6/350, PC-6/350-H1, PC-6/350-H2, PC-6/A, PC-6/A-H1, PC-6/A-H2, PC-6/B-H2, PC-6/B1-H2, PC-6/B2-H2, PC-6/B2-H4, PC-6/C-H2, PC-6/C1-H2, PC-6-H1, and PC-6-H2 airplanes. The MCAI states:

Pilatus Aircraft Ltd. has issued Pilatus PC-6 Service Bulletin No. 27-005, dated July 2, 2018. The service information contains procedures for removing and inspecting the flap actuator assemblies and pushrod assemblies, modifying or replacing the taper pins if necessary, and reinstalling the assemblies. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with this State of Design Authority, they have notified us of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all information and determined the unsafe condition exists and is likely to exist or develop on other products of the same type design.

We estimate that this proposed AD will affect 30 products of U.S. registry. We also estimate that it would take about 12 work-hours per product to comply with the basic inspection requirements of this proposed AD. The average labor rate is $85 per work-hour.

Based on these figures, we estimate the cost of the proposed AD on U.S. operators to be $30,600, or $1,020 per product.

In addition, we estimate that any necessary follow-on modification or replacement actions would require parts costing $30,000, for a cost of $1,000 per product. We have no way of determining the number of products that may need these actions.

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

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

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

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

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

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

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

Authority for This Rulemaking

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would establish Class E airspace extending upward from 700 feet above the surface at Chase Field Industrial Airport, Beeville-Chase Field, TX, in support of IFR operations at the airport.

Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2019-0222/Airspace Docket No. 19-ASW-5.” The postcard will be date/time stamped and returned to the commenter.

All communications received before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this notice may be changed in light of the comments received. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.

An electronic copy of this document may be downloaded through the internet at http://www.regulations.gov. Recently published rulemaking documents can also be accessed through the FAA's web page at http://www.faa.gov/air_traffic/publications/airspace_amendments/.

You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the ADDRESSES section for the address and phone number) between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal holidays. An informal docket may also be examined during normal business hours at the Federal Aviation Administration, Air Traffic Organization, Central Service Center, Operations Support Group, 10101 Hillwood Parkway, Fort Worth, TX 76177.

This document proposes to amend FAA Order 7400.11C, Airspace Designations and Reporting Points, dated August 13, 2018, and effective September 15, 2018. FAA Order 7400.11C is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11C lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

The FAA is proposing an amendment to Title 14 Code of Federal Regulations (14 CFR) part 71 by establishing Class E airspace extending upward from 700 feet above the surface to within a 6.7-mile radius of Chase Field Industrial Airport, Beeville-Chase Field, TX, to accommodate new standard instrument approach procedures. This action would enhance safety and the management of IFR operations at the airport.

Class E airspace designations are published in paragraph 6005 of FAA Order 7400.11C, dated August 13, 2018, and effective September 15, 2018, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.

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

This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.

Accordingly, pursuant to the authority delegated to me, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:

Authority for This Rulemaking

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would amend Class E airspace at Monroe-Walton County Airport, Monroe, GA to support IFR operations in the area.

Interested persons are invited to comment on this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal.

Communications should identify both docket numbers (Docket No. FAA-2019-0206 and Airspace Docket No. 19-ASO-6) and be submitted in triplicate to DOT Docket Operations (see ADDRESSES section for the address and phone number). You may also submit comments through the internet at http://www.regulations.gov.

Persons wishing the FAA to acknowledge receipt of their comments on this action must submit with those comments a self-addressed stamped postcard on which the following statement is made: “Comments to FAA Docket No. FAA-2018-0206; Airspace Docket No. 19-ASO-6.” The postcard will be date/time stamped and returned to the commenter.

All communications received before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this document may be changed in light of the comments received. All comments submitted will be available for examination in the public docket both before and after the comment closing date. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.

An electronic copy of this document may be downloaded through the internet at http://www.regulations.gov. Recently published rulemaking documents can also be accessed through the FAA's web page at http://www.faa.gov/air_traffic/publications/airspace_amendments/.

You may review the public docket containing the proposal, any comments received and any final disposition in person in the Dockets Office (see the ADDRESSES section for address and phone number) between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal holidays. An informal docket may also be examined between 8:00 a.m. and 4:30 p.m., Monday through Friday, except federal holidays at the office of the Eastern Service Center, Federal Aviation Administration, Room 350, 1701 Columbia Avenue, College Park, GA 30337.

This document proposes to amend FAA Order 7400.11C, Airspace Designations and Reporting Points, dated August 13, 2018, and effective September 15, 2018. FAA Order 7400.11C is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11C lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

The FAA proposes an amendment to Title 14 Code of Federal Regulations (14 CFR) part 71 to amend Class E airspace extending upward from 700 feet or more above the surface at Monroe-Walton County Airport, Monroe, GA, by increasing the airport radius to 6.9 miles (from 6.3 miles), and eliminating the southwest extension of the airport to accommodate airspace reconfiguration due to the decommissioning of the Monroe NDB and cancellation of the NDB approach. Also, the geographic coordinates of the airport would be adjusted to coincide with the FAA's aeronautical database.

Class E airspace designations are published in Paragraph 6005, of FAA Order 7400.11C, dated August 13, 2018, and effective September 15, 2018, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.

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

This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.

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

On February 22, 2019, VA published a proposed rulemaking to amend its regulations on the provision of necessary hospital care, medical services, and extended care services from non-VA entities or providers in the community. Federal Register (84 FR 5629). That rulemaking proposed to define and implement the new Veterans Community Care Program authorized by section 1703 of title 38, United States Code (U.S.C.), as that statute will be amended by section 101 of the John S. McCain III, Daniel K. Akaka, and Samuel R. Johnson VA Maintaining Internal Systems and Strengthening Integrated Outside Networks (MISSION) Act of 2018, effective upon VA's issuance of implementing regulations. For the sake of convenience and understanding, we will refer to provisions of section 1703, as section 101 of the MISSION Act will amend it, although we recognize that section 1703 as so amended is not legally effective until VA has published a final rule implementing the Veterans Community Care Program. The Veterans Community Care Program will permit eligible veterans to elect to receive hospital care, medical services, and extended care services from eligible entities and providers. VA asked for comments on the proposed rule on or before March 25, 2019. In that proposed rule, we noted that we did not include language to address the provisions in section 1703(l) regarding organ and bone marrow transplants. We advised that we would address this through a subsequent rulemaking. This rulemaking proposes to implement section 1703(l). We propose to modify § 17.4020, as proposed in VA's earlier proposed rulemaking, by amending paragraph (a) and adding a paragraph (d) to that section to govern decisions regarding organ and bone marrow transplant care.

To help the public better understand the effect of this supplemental notice of proposed rulemaking and this provision of law, we offer some additional background on both VA's transplant program and transplants in general. We believe this information would be helpful to the public by providing context for how transplant care is furnished by VA today and how the Organ and Procurement Transplantation Network operates. Some of the following discussion is excerpted and edited from an article by Dr. William Gunnar, “The VA Transplant Program: A Rebuttal to Criticism and a Look to the Future”, published online by the American Journal of Transplantation on February 12, 2019, cited as doi: 10.1111/ajt.15295.

The VA Transplant Program (VATP) was established decades ago during initial development of solid organ transplantation in the United States. It is well resourced, provides timely and high quality solid organ transplant care and services to the nation's veterans, and supports research and education missions of VA and affiliated academic medical centers. Access and outcomes data for fiscal years (FY) 2014-2018 show that the VATP received 12,801 solid organ and bone marrow transplant referrals (10,494 solid organ and 2,307 bone marrow), added 3,972 veterans to the Organ Procurement and Transplantaton Network (OPTN) waitlist, and performed 1,699 solid organ transplants (180 heart, 748 kidney, 694 liver, and 77 lung). Timeliness to transplant evaluation within 30 days from referral was over 98 percent in FY 2018. Thirty-day and one-year survival rates for veterans receiving a transplant during the 10-year period from October 1, 2008, to September 30, 2018, were 98.0 percent and 93.5 percent respectively for heart, 99.9 percent and 97.5 percent respectively for kidney; 97.7 percent and 90.5 percent respectively for liver; and 98.8 percent and 88.4 percent respectively for lung. Outcomes were on par or better than national data made publicly available by the Scientific Registry of Transplant Recipients. VATCs have leveraged VA specialty programs for veteran-prevalent diseases, such as posttraumatic stress disorder, to better ensure transplant candidacy for high-risk patients and to provide support to optimize post-transplantation outcomes.

The VATP is comprised of the following VA Transplant Centers (VATC): Five heart (Madison, Wisconsin; Nashville, Tennessee; Palo Alto, California; Richmond, Virginia; and Salt Lake City, Utah); seven kidney (Birmingham, Alabama; Bronx, New York; Houston, Texas; Iowa City, Iowa; Nashville, Tennessee; Pittsburgh, Pennsylvania; and Portland, Oregon); six liver (Houston, Texas; Madison, Wisconsin; Nashville, Tennessee; Pittsburgh, Pennsylvania; Portland, Oregon; and Richmond, Virginia); and two lung (Madison, Wisconsin; and Seattle, Washington). Three additional VATCs are planned for activation in FY 2019: One kidney transplantation program; one heart transplantation program; and one program for heart and lung transplants.

All VATCs are members of the OPTN and abide by OPTN policy. Some VATCs perform all transplantation care within VA as “in-house” programs and are independent OPTN members. Others are integrated with an academic medical center which is an OPTN member. These integrated VATCs have established infrastructure to provide pre- and post-transplant care at the VA medical facility, but transplant procedures are performed at the affiliate. Each VATC also supports veterans who transition transplantation care to VA after having received transplant procedures in the community.

VA policy establishes a standardized process for veteran referral to the VATP in order to facilitate timely and high-quality care. The referring VA medical facility submits veteran health information into a secure intranet-based application called Transplant Referral and Cost Evaluation/Reimbursement (TRACER, developed and implemented in 2013), the referring medical facility selects a VATC with patient concurrence, and TRACER then notifies the VATC. The VATC reviews the information and submits an initial review decision as to whether the clinical information supports further evaluation. Emergency referrals are decided within 48 hours and stable referrals within 5 business days. When referrals are accepted, the VATC completes an evaluation within 30 calendar days of the referral submission date for stable patients; emergency referrals may require transfer to the VATC for inpatient management and listing. Following evaluation and determination that the veteran is a transplant candidate, the VATC directs transplant-related care, orders additional testing as needed, and waitlists the veteran with OPTN when the candidate's clinical status is deemed appropriate. Each VATC is responsible for veteran transplant care and compliance with OPTN policy including maintenance of program-specific eligibility criteria. VA program offices do not dictate VATC clinical decisions. TRACER facilitates the referral process and tracks dates for VATC initial review decision, evaluation, OPTN waitlisting, and transplantation. Referring medical facilities may request a second opinion in TRACER if the primary VATC deems the veteran not-eligible for transplantation at its program. The referring medical facility may also submit an appeal to VA in TRACER if both primary and second VATC determinations are that the patient is not-eligible for transplantation. Appeals are reviewed by a national Transplant Surgical Advisory Board, and veterans deemed not eligible through the appeal process may be resubmitted to TRACER when clinical conditions change. TRACER also supports dual-OPTN listing at two transplant centers in response to requests by patients via referring facilities or VATCs.

Each veteran and her or his caregiver, as well as a living donor and living donor caregiver, if applicable, are supported with travel and lodging to and from home and the VATC for pre-operative evaluation, pre-operative testing or in-hospital care, the transplant procedure, the immediate post-transplant recovery, and necessary post-operative care and treatment. Evaluations for candidacy, wait-list management, and post-transplantation care may be completed using telehealth, thereby keeping the veteran close to home (or providing certain care in home). In fiscal year 2018, 12.7 percent of cardiac evaluations, 22.1 percent of kidney evaluations, 25.8 percent of liver evaluations, and 78.7 percent of lung evaluations were completed through telehealth. Veteran candidates can communicate with the VATC team through video connected care and secure messaging. Additional information regarding the VATP referral process can be found on the following website: https://www.va.gov/health/services/transplant/.

VATCs typically require veterans to travel for transplant procedures or for care when telehealth is not appropriate or desired by the veteran. Inequalities in geographic access to solid organ transplantation exist in the United States, are not limited to veterans enrolled in VA, and require many non-veterans to travel. Transplant care is complicated, and every transplant center requires significant resources that are simply unavailable in certain parts of the country. Four States are without an established transplant center (VA or non-VA); 14 States do not have a liver transplant center; 15 States do not have a cardiac transplant center; and 22 States do not have a lung transplant center. Prior studies suggest that distance to a transplant center may adversely impact access to transplant service, mortality on the OPTN waitlist, and transplant outcomes. Non-veteran patients living in small towns and isolated rural regions are 8-15 percent less likely to be placed on a waitlist and 10-20 percent less likely to undergo heart, kidney, and liver transplantation than patients in urban environments. For perspective, approximately 2.8 million VA enrolled veterans (approximately 31 percent) reside in a rural or highly rural location.

TRACER data identifies that referrals from VA medical facilities located less than 100 miles from the selected VATC experienced shorter average times for initial decision review, evaluation, and placement on the OPTN waitlist. A majority of these patients receive other care at the VATC and are “self-referred” by the facility through TRACER to the VATC. No statistically significant differences were identified in heart, kidney, liver, or lung referral timeliness to initial decision review, evaluation, or placement on the OPTN waitlist for distances of 100-300 miles, 301-500 miles, and greater than 500 miles. Distance between the referring VA medical facility and the VATC, including distances less than 100 miles and greater than 500 miles, was not found to impact the rate of mortality on the OPTN waitlist, time to transplantation, or post-transplant survival. While travel distance may impact veteran or caregiver satisfaction, there is no demonstrated impact on key clinical outcomes.

In addition to the clinical transplantion care provided to veterans, VATCs have significant impacts on the academic missions of VA and affiliated medical centers. Nearly all VATC physicians hold faculty appointments at affiliated academic centers; most are involved in graduate medical education; and several participate in basic science or clinical research related to transplantation. Trainees at VATCs, both students and residents, benefit from participation in transplantation care of veterans and include surgery, general medicine, medical subspecialties, behavioral health, nursing, and pharmacy. Numerous research studies and publications from VATCs have addressed transplantation-related care, disease mechanisms, and clinical outcomes for veterans.

First, we would amend § 17.4020(a), as proposed in VA's earlier proposed rulemaking. As initially proposed § 17.4020(a) would incorporate a provision from the Veterans Choice Program at § 17.1515(a) related to a covered veteran's election to receive care in the community. This provision would be carried over to the Veterans Community Care Program to confirm a veteran's ability to elect to receive community care under appropriate circumstances, consistent with section 1703(d)(3). The change proposed in this supplemental notice of proposed rulemaking (SNPRM) would amend § 17.4020(a), as it was proposed in VA's earlier proposed rulemaking, to create an exception to the ability to elect to receive non-VA care for organ and bone marrow transplants in paragraph (d), as further described below.

Proposed § 17.4020(d) would implement section 1703(l), related to organ and bone marrow transplants. Section 1703(l) states that VA must determine whether to authorize an organ or bone marrow transplant for a covered veteran at a non-VA facility in the case of a covered veteran in need of an organ or bone marrow transplant who has, in the opinion of the primary care provider of the veteran, a medically compelling reason to travel outside of the region of the Organ Procurement and Transplantation Network (OPTN) in which the veteran resides. (OPTN matches organs with transplant candidates on waiting lists in need of transplantation, but does not regulate bone marrow transplantation. Regions have been used to facilitate transplantation and communication among OPTN member organizations.) While section 1703(d)(3) generally provides that a covered veteran who is determined by VA to meet eligibility criteria in 1703(d)(1) has the ability to decide whether to receive care in the community, section 1703(l) expressly provides to the Secretary the authority to decide whether to authorize organ or bone marrow transplant care in the community for certain veterans, specifically those who require an organ or bone marrow transplant and who have, in the opinion of the primary care provider of the veteran, a medically compelling reason to travel outside of the OPTN region in which the veteran resides.

Section 1703(l) qualifies determinations under section 1703(d) and (e) for these veterans. It is a well- accepted principle of statutory construction that a more specific provision is read to qualify a more general provision in a law. Congress often states general principles that are further qualified or revised in other provisions of law. Sections 1703(d) and 1703(l) fit this model. Section 1703(d) establishes a general rule that covered veterans who satisfy one of the conditions for eligibility are able to elect to have VA authorize their care in the community or to schedule an appointment with a VA provider. Section 1703(l) inverts this decision making and states unequivocally that the Secretary makes the determination of whether to authorize community care for covered veterans requiring an organ or bone marrow transplant and who have a medically compelling reason to travel outside of the OPTN region in which they reside to receive the transplant. For any other type of health care, section 1703(d) controls, and the covered veteran's election is binding on VA. For those veterans described in section 1703(l), however, this provision of law controls. If section 1703(d) applied to covered veterans described in section 1703(l), then section 1703(l) would have no meaning or effect. There is a strong presumption against reading a provision of law that would render other provisions of the statute superfluous or unnecessary. Reading section 1703(d) to authorize covered veterans described in section 1703(l)(2) to determine where to receive their care would render section 1703(l)(1) meaningless, and therefore such a reading should be rejected.

We wish to be clear on the effect of section 1703(l). The Secretary's discretion is limited to covered veterans who: (1) Meet one or more of the eligibility criteria under proposed § 17.4010; (2) require an organ or bone marrow transplant; and (3) have a medically compelling reason to travel outside the OPTN region in which the veteran resides to receive such a transplant. The first condition has already been described in VA's earlier proposed rule. The second condition, requiring an organ or bone marrow transplant (as required by section 1703(l)(2)(A)), would be satisfied when VA has determined that a transplant is clinically necessary and appropriate. For the third condition, we propose to regulate the factors that would be considered when a medically compelling reason to travel outside the OPTN region in which the veteran resides exists. However, before describing these factors, we wish to provide some examples to illustrate the scope of this authority.

We note initially that this section only applies for a covered veteran (as defined in § 17.4005) who meets one or more of the eligibility criteria under § 17.4010. If, for example, a covered veteran resided near a VATC that could furnish the care within the designated access standards proposed under § 17.4040 and no other eligibility criterion applied, the veteran would not be eligible to elect to have VA authorize their care in the community. If the veteran was eligible for care in the community under one or more of the eligibility criteria, and if the veteran did not have a medically compelling reason to travel outside the OPTN region in which the veteran resided, the veteran's election would control because the Secretary would not have the discretion conferred by section 1703(l). Take, as an example, a veteran who lived more than a 60 minute average driving time from a VATC within the OPTN region in which the veteran resides. If a VATC were within the veteran's OPTN region, and assuming this was a typical case, it is very likely that the VATC could furnish the transplant care safely, timely, and effectively, with relatively little travel burden. Given these facts, there would likely be no medically compelling reason to travel outside the OPTN region for the transplant care due to the availability of the VATC. Therefore, it would be up the veteran to decide whether to receive care from a community transplant center or through a VATC.

Proposed section 17.4020(d)(1) would state that, in the case of a covered veteran described in paragraph (d)(3), VA would determine whether to authorize an organ or bone marrow transplant for the covered veteran through an eligible entity or provider. This language is entirely consistent with section 1703(l)(1). Proposed section 17.4020(d)(3) would restate the language in 1703(l)(2) to provide that this paragraph would only apply to a covered veteran who met one or more conditions of eligibility under section 17.4010(a) and (1) required an organ or bone marrow transplant, and (2) has, in the opinion of the primary care provider of the veteran, a medically compelling reason to travel outside the region of the Organ Procurement and Transplantation Network in which the veteran resides, to receive such transplant.

VA would, in section 17.4020(d)(3)(i), clarify that VA would determine, based upon generally-accepted medical criteria, whether an organ or bone marrow transplant is likely to be indicated. These generally-accepted medical criteria include the exercise of some clinical discretion, which we do not purport or intend to regulate, but which are generally known by recognized medical experts and accredited transplant centers. Such criteria are those commonly accepted across the country as related to general suitability and qualification for a transplant from any provider. These criteria would support decision making for comprehensive transplantation evaluation. VA understands that each OPTN member organ transplant center and each bone marrow transplant center determines transplant suitabilty of each patient for its program in consideration of patient and program factors. Each transplant center must define and apply its own eligibility criteria in consideration of individual patients. Current VA process supports veterans having a formal evaluation by at least two transplant centers, and published policy also defines an appeal process with review by a multidisciplinary Transplantation Surgery Advisory Board to ensure that patients receive due consideration for transplantation.

Proposed section 17.4020(d)(2) would provide a non-exhaustive list of factors for consideration in making determinations as to whether: (1) There is a medically compelling reason to travel outside the OPTN region, and (2) organ or bone marrow transplant care would be provided in the community. We emphasize that decisions should be personalized in consideration of the veteran's preference and health care needs but balanced with efforts to ensure high-quality care. There would be four factors to consider in both determinations. First, specific patient factors would be considered. We would not expressly describe specific factors in the interest of avoiding the regulation of medical practice, but we offer a few examples here for understanding and reference. For example, it may be relevant to consider the characteristics of disease processes which might warrant care in specific transplantation programs. Certain disease indications for transplant warrant referral to sub-specialty centers with particular expertise for that disease process. Another factor could be patient preferences regarding waitlist time and organ availability. Characteristics of waitlists including mortality rate and time to transplant will be considered for shared decision making with veterans. Yet another factor may be access to specialty support programs for the unique needs of the individual veteran; and comprehensive care coordination. Many veterans requiring transplants also face other health issues, including substance use disorder, posttraumatic stress disorder, and other mental health disorders. The ability to address the totality of these conditions in an integrated, supportive, and patient-centered manner is often critical for the patient's health, candidacy for transplantation, and successful post-transplantation outcomes.

Second, VA and the primary care provider would consider which facilities meet VA's standards for quality, including quality metrics and outcomes, for the required transplant. This reflects VA's responsibility to ensure veterans receive high quality care. We note that VA is required by section 1703C to establish standards for quality, and these standards and their respective quality metrics (which are consistent with industry standard metrics) would be used to help inform VA's determination. Additionally, VA would assess the effectiveness of transplantation care using publicly-reported risk-adjusted outcomes of patient and graft survival, such as Scientific Registry of Transplantation Recipients data for solid organ transplantation programs.

Third, VA and the primary care provider would consider the travel burden on covered veterans based upon their medical conditions and the geographical location of eligible transplant centers. This would allow consideration of the realities of long travel distances for veterans who have advanced disease processes, who reside in locations without any qualified transplant centers, or whose caregivers are unduly burdened by travel. As noted in the section of this SNPRM providing background information on the VATP, many Americans face considerable travel distances or driving times when seeking transplant care.

Finally, VA and the primary care provider would consider the timeliness of transplant center evaluations and management. In some transplant cases, time for evaluation and waitlisting is a critical factor affecting patient outcomes and health and well-being.

Cumulatively, these factors would allow VA to make determinations on whether to provide transplantation care in the community and primary care providers to determine whether there is a medically compelling reason to travel outside the OPTN region of the veteran's residence. This list of factors is not intended to be exhaustive, as each transplant case is unique and VA needs to maintain flexibility to ensure that covered veterans receive the best and most appropriate care. We note that any covered veteran who disagreed with VA's determination could appeal this determination through VA's clinical appeals process.

As a general matter, a veteran's primary care provider may not, and often will not, be the health care provider who is actively managing the patient's transplant care needs, nor will the primary care provider necessarily have an understanding of the unique needs faced by veterans requiring a transplant. While section 1703(l) establishes that the determination of a medically compelling reason to travel outside the OPTN region in which the veteran resides is made by the primary care provider, we believe in practice, this will be made in consultation with the appropriate specialists that are evaluating the covered veteran and managing the patient's transplant needs.

We note that section 153 of the MISSION Act added a new section 1788 to title 38, United States Code, specifically authorizing VA to provide for an operation on a live donor to carry out a transplant procedure for an eligible veteran, notwithstanding that the live donor may not be eligible for VA health care. VA will issue separate regulations concerning this new authority, and the preceding discussion is not dependent upon the promulgation of such regulations. Any comments on care for living donors will be considered outside the scope of this rulemaking.

The Code of Federal Regulations, as proposed to be revised by the proposed rulemaking at 84 FR 5629 and this SNPRM, would represent the exclusive legal authority on this subject. No contrary guidance or procedures would be authorized. All VA guidance would be read to conform with the proposed rulemaking at 84 FR 5629 and this SNPRM if possible or, if not possible, such guidance would be superseded by this SNPRM and the proposed rulemaking at 84 FR 5629.

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

The Secretary hereby certifies that this SNPRM 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. Although some eligible entities or providers that would furnish care and services to veterans under this rule might be considered small entities, there would be no significant adverse economic impact. To the extent there is any impact on small entities, it would be a potential increase in business due to proposed expanded eligibility for non-VA care. Therefore, pursuant to 5 U.S.C. 605(b), these amendments would be exempt from the initial and final regulatory flexibility analysis requirements of 5 U.S.C. 603 and 604.

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, and other advantages; distributive impacts; and equity). Executive Order 13563 (Improving Regulation and Regulatory Review) emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. Executive Order 12866 (Regulatory Planning and Review) defines a “significant regulatory action,” requiring review by the Office of Management and Budget (OMB) as “any regulatory action that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in this Executive Order.”

VA has examined the economic, interagency, budgetary, legal, and policy implications of this regulatory action and determined that the action would be an economically significant regulatory action under Executive Order 12866, because it will have an annual effect on the economy of $100 million or more. VA's impact analysis can be found as a supporting document at http://www.regulations.gov, usually within 48 hours after the rulemaking document is published. Additionally, a copy of the rulemaking and its regulatory impact analysis are available on VA's website at http://www.va.gov/ orpm/, by following the link for “VA Regulations Published.” This SNPRM is expected to be an E.O. 13771 regulatory action. Details on the estimated costs of this rule can be found in the rule's regulatory impact analysis.

Executive Order 12866 also directs agencies to “in most cases . . . include a comment period of not less than 60 days.” This SNPRM would address one provision for the new Veterans Community Care Program. Providing a comment period of 15 days would allow the Secretary to ensure the provisions of this SNPRM can be finalized with the regulations for the rest of the new Veterans Community Care Program at the same time. This would ensure a smooth transition from the current Veterans Choice Program that will expire on June 6, 2019, and prevent lapses in regulatory authority for VA's national community care program. Delays in implementation of the Veterans Community Care Program and provisions related to organ and bone marrow transplants arising because the regulatory standards and guidelines were not in place by June 6, 2019, would result in inconsistent decision making that could harm veterans' health outcomes. Having clear, consistent criteria is essential to ensuring that veterans receive the right care in the right place at the right time. Moreover, we believe that VA community care is now a familiar benefit to the public and that providing 15 days would still be a sufficient period of time for the public to comment on this single aspect of the new Veterans Community Care Program. In sum, providing a 60-day public comment period would be against public interest and contrary to the health and safety of eligible veterans. For the above reasons, the Secretary issues this rule with a public comment period of 15 days.

The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may 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 SNPRM would have no such effect on State, local, and tribal governments, or on the private sector.

The Catalog of Federal Domestic Assistance numbers and titles for the programs affected by this document are as follows: 64.009, Veterans Medical Care Benefits; and 64.018, Sharing Specialized Medical Resources.

The Secretary of Veterans Affairs, or designee, approved this document 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. Robert L. Wilkie, Secretary, Department of Veterans Affairs, approved this document on February 28, 2019, for publication.

For the reasons set forth in the preamble, we propose to amend 38 CFR part 17 as follows:

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

Idaho submitted its initial Regional Haze SIP to the EPA on October 25, 2010, for the first regional haze planning period ending in 2018, which the EPA approved on June 22, 2011, and November 8, 2012. 1 Five years after submittal of the initial regional haze plan, states were required to submit progress reports that evaluate progress towards the RPGs for each mandatory Class I Federal area  2 (Class I area) within the state and in each Class I area outside the state which may be affected by emissions from within the state. 40 CFR 51.308(g). States were also required to submit, at the same time as the progress report, a determination of the adequacy of the state's existing regional haze plan. 40 CFR 51.308(h). On June 28, 2016, the Idaho Department of Environmental Quality (IDEQ) submitted, as a SIP revision, a report on the progress made in the first implementation period towards the RPGs for Class I areas. EPA is proposing to approve Idaho's progress report on the basis that it satisfies the requirements of 40 CFR 51.308. We also propose to find that Idaho's progress report demonstrates that the state's long-term strategy and emission control measures in the existing Regional Haze SIP are sufficient to enable Idaho to meet all established RPGs for 2018.

To facilitate a better understanding of Idaho's progress report as well as the EPA's evaluation of it, this section provides background on the regional haze program in Idaho.

The EPA has established a metric for determining visibility conditions at Class I areas referred to as the “deciview index,” which is measured in deciviews, as defined in 40 CFR 51.301. The deciview index is calculated using monitoring data collected from the Interagency Monitoring of Protected Visual Environments (“IMPROVE”) network monitors. Idaho has five Class I areas: Hells Canyon Wilderness, Sawtooth Wilderness, Craters of the Moon National Monument, Yellowstone National Park, and Selway-Bitterroot Wilderness. Both Hells Canyon Wilderness and Yellowstone National Park have portions within Idaho, but the majority of the land masses for both of these Class I areas are in other states. For this reason, Idaho set the RPGs for Hells Canyon Wilderness, Sawtooth Wilderness, and Craters of the Moon National Monument and the 5-year Progress Report analyzes progress towards the RPGs at these three Class I areas.

In developing its initial Regional Haze SIP as part of the Western Regional Air Partnership (“WRAP”), Idaho determined, and the EPA in its approval agreed, that implementation of best available retrofit technology (“BART”) and other existing measures in the State's regional haze plan was sufficient to address the visibility impact of sources in Idaho on Class I areas in other states. See 77 FR 66929, 66933. Therefore, Idaho's progress report does not address the visibility impact of Idaho sources on Class I areas in other states.

Under the Regional Haze Rule, a state's initial Regional Haze SIP must establish two RPGs for each of its Class I areas: One for the 20-percent least impaired days and one for the 20-percent most impaired days. The RPGs must provide for an improvement in visibility on the 20-percent most impaired days and ensure no degradation in visibility on the 20-percent least impaired days, as compared to visibility conditions during the baseline period. In establishing the RPGs, a state must consider the uniform rate of visibility improvement from the baseline to natural conditions in 2064 and the emission reductions measures needed to achieve it. Idaho set the RPGs for the Hells Canyon Wilderness, Sawtooth Wilderness, and the Craters of the Moon National Monument Class I areas. In setting the RPGs for these three Class I areas, Idaho used atmospheric air quality modeling based on projected emission reductions from control strategies in Idaho's Regional Haze SIP, as well as emission reductions expected to result from other federal, state, and local air quality programs.

Idaho relied on the WRAP technical data and analyses in a report titled “Western Regional Air Partnership Regional Haze Rule Reasonable Progress Summary Report” (“WRAP Report”), dated June 28, 2013, included as an appendix to the progress report. The WRAP Report analyzes monitoring data collected in Idaho during the 2005-2009 period, and it relies on emission data reported to the EPA's National Emissions Inventory (NEI) up until 2011. Idaho then supplemented the information in the WRAP report with more current 2007-2011 visibility data for its Class I areas as part of the progress report adopted by the state in 2015.

This section describes the contents of Idaho's progress report and the EPA's evaluation of the report, as well as the EPA's evaluation of the determination of adequacy required by 40 CFR 51.308(h) and the requirement for state and Federal Land Manager (FLM) coordination in 40 CFR 51.308(i).

In its progress report, Idaho provided a description of the control measures in the state's Regional Haze SIP that the state relied on to implement the regional haze program. Idaho relied in its Regional Haze SIP upon, among other things, BART controls, its Prevention of Significant Deterioration/New Source Review permitting program, and its smoke management programs for agricultural and forestry burning to achieve the RPGs it established for its Class I areas. Idaho included a description of these programs in the progress report, which is summarized below.

Idaho's original Regional Haze SIP imposed BART-level controls on two sources, the #5 Rotary Kiln at the P4 Production (formerly Monsanto) Soda Springs facility and the Riley Boiler at The Amalgamated Sugar Company (TASCO), Nampa facility. In 2005, P4 Production underwent a Best Available Control Technology (BACT) review and installed a lime-concentrated dual-alkali (LCDA) scrubber on the #5 Rotary Kiln to control sulfur dioxide (SO 2 ) emissions. Idaho determined, and EPA in its approval agreed, that BART for the #5 Rotary Kiln was an emission limit of 143 pounds per hour of SO 2 achieved through application of the LCDA scrubber. See 76 FR 36329, 36339 (Jun. 22, 2011). 3 Idaho also concluded that existing controls were BART for the nitrogen oxide (NO X ) and particulate matter (PM) emissions from the #5 Rotary Kiln. EPA also approved this determination. See 76 FR 36329, 36339 (Jun. 22, 2011). The emission limits are embodied in federally enforceable permits that Idaho continues to administer.

For TASCO, Idaho determined that flue gas desulfurization and low NO X burners with over-fire air were the appropriate control technologies for the BART-eligible Riley Boiler. EPA approved BART for the Riley Boiler on May 22, 2012 (77 FR 66929). Subsequently, Idaho submitted revisions to its Regional Haze SIP that included a revised BART determination for the TASCO Nampa facility. Specifically, Idaho's revised BART determination included a more stringent NO X emission limit, a more stringent PM emission limit, and a BART alternative to replace the SO 2 BART determination. In addition to the more stringent NO X and PM emission limits for the Riley Boiler, the BART alternative relied on control of NO X emissions from two non-BART eligible boilers at the TASCO Nampa facility, as well as taking into account the emission reductions resulting from the permanent shutdown of three coal-fired pulp dryers. EPA approved Idaho's revised BART determination for the TASCO Nampa facility on April 28, 2014. See 79 FR 23273, 23277. The BART emissions limits are embodied in a federally enforceable permit that went into effect on December 23, 2011. Idaho continues to administer this permit.

Idaho's progress report states that a key regulatory program for addressing visibility impairment from new or modified industrial stationary sources is the state's PSD/NSR program. This program protects visibility in Class I areas from impacts from new major or modified major stationary sources. According to the progress report, Idaho's PSD program requires new or major modifications to model the emissions impacts on Class I areas within 300 kilometers to determine if the change in visibility above natural levels is significant. According to the progress report, Idaho continues to implement the PSD/NSR program.

In addition, Idaho continues to implement its crop residue and burning program. EPA published its approval of Idaho's SIP revisions relating to open burning and crop residue disposal requirements on August 1, 2008 (73 FR 44915, 44919), March 19, 2013 (78 FR 16760, 16791), and most recently on June 19, 2018 (83 FR 28382, 28385). The compliance rate has improved through education and outreach, and Idaho DEQ has hired a meteorologist to guide burn decisions. There have also been improvements in the prescribed burning (forestry) program. Specifically, Idaho DEQ is working closely with the Idaho and Montana Airshed group, and Idaho DEQ's smoke manager and meteorologist are involved in the day to day burn decisions. Both the crop residue and burning and the prescribed burning programs have improved through cooperative agreements with the Idaho Department of Lands and the burn permits now have specific language requiring burners to comply with Idaho open burning rules.

In addition to the evaluation of control measures, Idaho documented the differences between the visibility conditions during the baseline period (2000-2004), the first progress period (2005-2009), and the most current five-year averaging period (2010-2014). Idaho used data available at the time Idaho developed the progress report in 2015. As part of our review, the EPA supplemented this information with current 2012-2016 data, as shown in Table 1. 4

As shown in Table 1, all Class I areas experienced improvements in visibility for the 20-percent least impaired days between the baseline (2000-2004) and the most recent (2012-2016) visibility periods. According to Idaho's progress report, all Class I areas are meeting the RPGs for the 20-percent least impaired days. Idaho's progress report included an analysis of progress and impediments to progress. Regarding the 20-percent most impaired days, according to the most recent monitoring data (2012-2016), the Selway-Bitterroot Wilderness (SULA1 monitor) is meeting the RPG for the 20-percent most impaired days. However, according to the 2012-2016 data, visibility in the Sawtooth Wilderness (SWAT1 monitor) and the Craters of the Moon NM (CRMO1 monitor) is not meeting the 2018 RPGs for the 20-percent most impaired days.

According to the progress report, visibility has not improved in the Sawtooth Wilderness and Craters of the Moon NM due to smoke from episodic wildfires in the area. Figures 6, 7, and 8 in the progress report show that SO 2 and NO X emissions have decreased since 2000. In contrast, coarse PM emissions have increased during the same period. Figure 14, Figure 15, and Appendix D of the progress report show that, even though there has been a steady reduction in ammonium sulfate formation since 2000, indicative of a reduction in anthropogenic contributions to visibility impairment, particulate organic mass has consistently remained the dominant contributor to light extinction. The Sawtooth Wilderness and Craters of the Moon NM experienced a notable spike in light extinction caused by particulate organic mass emissions in 2012, which likely contributed to the areas not meeting their RPGs. The 2012 fires potentially impacting the Sawtooth Wilderness and Craters of the Moon NM include the Halstead Fire (181,000 acres), Mustang Complex (340,600 acres), and the Trinity Ridge Fire (146,800 acres). 6

The progress report also contained a review of Idaho's visibility monitoring strategy. Idaho concluded that the IMPROVE network continues to comply with the monitoring requirements in the Regional Haze Rule and that no modifications to Idaho's visibility monitoring strategy are necessary at this time.

The Idaho progress report also included a summary of the emissions reductions achieved throughout the state from the control measures discussed above. Specifically, Idaho identified emissions reductions achieved through emissions controls on Idaho BART-eligible sources, including the P4 Production and the TASCO Nampa facilities. According to Idaho, implementation of BART caused significant reductions in emissions at both facilities. Installation of the LCDA scrubber on the P4 Production facility reduced SO X emissions by 11,000 tons per year. NO X emissions at the TASCO Nampa facility have also declined due to compliance with the BART requirements, namely implementation of low NO X burners, switching to natural gas, and the permanent shutdown of pulp dryers. Specifically, the BART alternative for the TASCO Nampa Facility achieved NO X emissions reductions of 221 tons per year, SO 2 emissions reductions of 20.6 tons per year, and PM emissions reductions of 113 tons per year (78 FR 38872).

The progress report also discussed improvements in Idaho's smoke management programs made during the first planning period, as noted above. The progress report summarized changes in emission inventories for all major visibility impairing pollutants from point, area, on-road mobile, off-road mobile, oil and gas, fugitive and road dust, and anthropogenic fire source categories in the state. For these summaries, emissions during the baseline years are represented using a 2002 inventory, which was developed with support from the WRAP for use in the original Regional Haze SIP development. Differences between inventories are represented as the differences between the 2002 inventory, the 2008 inventory, and the 2011 inventory which leverages recent inventory development work performed by the WRAP for the West-wide Jump Start Air Quality Modeling Study (WestJumpAQMS) and Deterministic & Empirical Assessment of Smoke's Contribution to Ozone Project (DEASCO 3 ) modeling projects.

The progress report also included an analysis tracking the change in emissions since the first progress period and the most recent progress period. Specifically, Idaho states that there has been a substantial reduction in anthropogenic sources of both SO 2 and NO X . Estimated emissions reductions for SO 2 and NO X are summarized in Table 2 and Table 3, below. These reductions are primarily attributed to the BART controls and the Tier II reductions in sulfur content of fuels and NO X vehicle emission standards. We note that the other visibility impairing pollutants (primary organic aerosols, elemental carbon) also generally declined as detailed in Chapter 2.3 of the progress report. As shown in Table 4 below, emissions increased for fine and coarse particulate matter because of a major change to the fugitive road dust calculations between 2008 and 2011. 7

In its progress report, Idaho concluded that the state is making adequate progress in improving visibility as a result of actions identified in the Regional Haze SIP, as well as actions taken by adjoining states, the federal government, the WRAP, and the Western States Air Resources Council.

In accordance with 40 CFR 51.308(h)(1), if the state determines that the existing implementation plan requires no further substantive revision in order to achieve established goals for visibility improvement and emissions reductions, the state must provide to the Administrator a negative declaration that further revision of the existing implementation plan is not needed at this time. Within the progress report, Idaho provided a negative declaration stating that further revision of the existing implementation plan is not needed. The basis for the state's negative declaration is the finding that visibility on the 20-percent least impaired days has improved from the baseline period, and the Selway-Bitterroot Wilderness Class I area attained its 2018 RPGs at the IMPROVE monitor. The Sawtooth Wilderness and the Craters of the Moon NM did not meet the 2018 RPGs for the 20-percent most impaired days at their respective monitors, which Idaho demonstrated was due to smoke from wildfires in 2012. 8

Accordingly, the EPA proposes to find that Idaho adequately addressed the requirements in 40 CFR 51.308(h) in its determination that the existing Idaho Regional Haze SIP requires no substantive revisions at this time.

In accordance with 40 CFR 51.308(i), the state must provide the FLMs with an opportunity for consultation, in person and at least 60 days prior to holding any public hearings on an implementation plan (or plan revision). The state must also include a description of how it addressed any comments provided by the FLMs. The State of Idaho invited the FLMs to comment on its draft progress report on January 28, 2016, for a 60-day comment period ending March 28, 2016, prior to releasing the report for public comment. Idaho included the FLM comment and a description of how it addressed the comment in Appendix E of the progress report.

The EPA proposes to find that Idaho has addressed the requirements in 40 CFR 51.308(i). Idaho provided a 60-day period for the FLMs to comment on the progress report, which was at least 60 days before seeking public comments, and provided a summary of these comments and responses to these comments in the progress report.

The EPA is proposing to approve the Idaho Regional Haze Progress Report submitted to the EPA on June 28, 2016, as meeting the applicable requirements of the CAA and Regional Haze Rule, as set forth in 40 CFR 51.308(g). The EPA proposes to find that the existing Regional Haze SIP is adequate to meet the state's visibility goals and requires no substantive revision at this time, as set forth in 40 CFR 51.308(h). We propose to find that Idaho fulfilled the requirements in 40 CFR 51.308(i) regarding state coordination with FLMs.

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

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

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

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

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

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

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

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

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

• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because it does not involve technical standards; and

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

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

Public Comments

We want any final rule resulting from this proposal to be as effective as possible. Therefore, we invite Tribal and governmental agencies, the scientific community, industry, and other interested parties to submit comments or recommendations concerning any aspect of this proposed rule. Comments should be as specific as possible.

To issue a final rule to implement this proposed action, we will take into consideration all comments and any additional information we receive. Such information may lead to a final rule that differs from this proposal. All comments, including commenters' names and addresses, if provided to us, will become part of the supporting record.

You may submit your comments and materials concerning the proposed rule by one of the methods listed in ADDRESSES . Comments must be submitted to http://www.regulations.gov before 11:59 p.m. (Eastern Time) on the date specified in DATES . We will not consider hand-delivered comments that we do not receive, or mailed comments that are not postmarked, by the date specified in DATES .

We will post your entire comment—including your personal identifying information—on http://www.regulations.gov. If you provide personal identifying information in your comment, you may request at the top of your document that we withhold this information from public review. However, we cannot guarantee that we will be able to do so.

Comments and materials we receive, as well as supporting documentation we used in preparing this proposed rule, will be available for public inspection on http://www.regulations.gov. All comments and materials we receive, as well as all supporting documentation, will be available by appointment, during normal business hours, at the U.S. Fish and Wildlife Service, Pacific Regional Office (see FOR FURTHER INFORMATION CONTACT ).

We particularly seek comments regarding:

• The proposed geographic boundary of the NEP;

• Information pertaining to the California condor as it relates to the proposed reintroduction effort;

• Effects of the proposed reintroduction on other native species and the ecosystem; and

• The adequacy of the proposed regulations for the NEP.

In accordance with our Interagency Cooperative Policy for Peer Review in Endangered Species Act Activities, which was published on July 1, 1994 (59 FR 34270), and the internal memorandum clarifying the Service's interpretation and implementation of that policy (USFWS in litt. 2016), we will seek the expert opinion of at least three appropriate independent specialists regarding scientific data and interpretations contained in this proposed rule. We will send copies of this proposed rule to the peer reviewers immediately following publication in the Federal Register . The purpose of such review is to ensure that our decisions are based on scientifically sound data, assumptions, and analysis. Accordingly, the final decision may differ from this proposal.

The 1982 amendments to the Act (16 U.S.C. 1531 et seq. ) included the addition of section 10(j), which allows for the designation of reintroduced populations of listed species as “experimental populations.” Under section 10(j) of the Act and our regulations in title 50 of the Code of Federal Regulations (at 50 CFR 17.81), the Service may designate as an experimental population a population of endangered or threatened species that has been or will be released into suitable natural habitat outside the species' current natural range (but within its probable historic range, absent a finding by the Director of the Service in the extreme case that the primary habitat of the species has been unsuitably and irreversibly altered or destroyed).

Before authorizing the release as an experimental population of any population (including eggs, propagules, or individuals) of an endangered or threatened species, and before authorizing any necessary transportation to conduct the release, the Service must find by regulation that such release will further the conservation of the species. In making such a finding the Service uses the best scientific and commercial data available to consider:

(1) Any possible adverse effects on extant populations of a species as a result of removal of individuals, eggs, or propagules for introduction elsewhere (see Donor Stock Assessment and Effects on Donor Population, below);

(2) the likelihood that any such experimental population will become established and survive in the foreseeable future (see Likelihood of Population Establishment and Survival and Addressing Causes of Extirpation, below);

(3) the relative effects that establishment of an experimental population will have on the recovery of the species (see Relationship of NEP to Recovery Efforts, below); and

(4) the extent to which the introduced population may be affected by existing or anticipated Federal or State actions or private activities within or adjacent to the experimental population area (see Likelihood of Population Establishment and Survival, below; National Park Service (NPS) 2018, entire).

Furthermore, as set forth in 50 CFR 17.81(c), all regulations designating experimental populations under section 10(j) must provide:

(1) Appropriate means to identify the experimental population, including, but not limited to, its actual or proposed location, actual or anticipated migration, number of specimens released or to be released, and other criteria appropriate to identify the experimental population(s) (see Location and Boundaries of the NEP, below);

(2) a finding, based solely on the best scientific and commercial data available, and the supporting factual basis, on whether the experimental population is, or is not, essential to the continued existence of the species in the wild (see Is the Proposed Experimental Population Essential or Nonessential?, below);

(3) management restrictions, protective measures, or other special management concerns of that population, which may include but are not limited to, measures to isolate and/or contain the experimental population designated in the regulation from natural populations (see Management, below); and

(4) a process for periodic review and evaluation of the success or failure of the release and the effect of the release on the conservation and recovery of the species (see Monitoring and Evaluation, below).

Under 50 CFR 17.81(d), the Service must consult with appropriate State fish and wildlife agencies, local governmental entities, affected Federal agencies, and affected private landowners in developing and implementing experimental population rules. To the maximum extent practicable, 10(j) rules represent an agreement between the FWS, the affected State and Federal agencies, and persons holding any interest in land that may be affected by the establishment of an experimental population.

Under 50 CFR 17.81(f), the Secretary may designate critical habitat as defined in section 3(5)(A) of the Act for an essential experimental population. No designation of critical habitat will be made for nonessential populations. In those situations where a portion or all of an essential experimental population overlaps with a natural population of the species during certain periods of the year, no critical habitat will be designated for the area of overlap unless implemented as a revision to critical habitat of the natural population for reasons unrelated to the overlap itself.

Any population determined by the Secretary to be an experimental population will be treated as if it were listed as a threatened species for purposes of establishing protective regulations with respect to that population. The protective regulations adopted for an experimental population will contain applicable prohibitions, as appropriate, and exceptions for that population.

Any experimental population designated for a listed species (1) determined not to be essential to the survival of that species and (2) not occurring within the National Park System or the National Wildlife Refuge System, will be treated for purposes of section 7 (other than paragraph (a)(1) thereof) as a species proposed to be listed under the Act as a threatened species.

Any experimental population designated for a listed species that either (1) has been determined to be essential to the survival of that species, or (2) occurs within the National Park System or the National Wildlife Refuge System as now or hereafter constituted, will be treated for purposes of section 7 of the Act as a threatened species. Notwithstanding the foregoing, any biological opinion prepared pursuant to section 7(b) of the Act and any agency determination made pursuant to section 7(a) of the Act will consider any experimental and nonexperimental populations to constitute a single listed species for the purposes of conducting the analyses under such sections.

We listed the California condor as an endangered species under the Endangered Species Preservation Act of 1966 (ESPA) on March 11, 1967 (32 FR 4001, March 11, 1967). This list was later codified in part 17 of title 50 in the U.S. Code of Federal Regulations (35 FR 16048, October 13, 1970). With the passage of the Endangered Species Act of 1973 (ESA), those species previously listed in the Code of Federal Regulations were directly incorporated into the Lists of Endangered and Threatened Wildlife and Plants under the ESA, found at 50 CFR 17.11 and 17.12. In October 1996, we designated a nonessential experimental population of the California condor in portions of northern Arizona, southern Utah, and southern Nevada (61 FR 54044, October 16, 1996). Therefore, the California condor is currently listed as an endangered species wherever it is found, except in portions of northern Arizona, southern Utah, and southern Nevada, where it is considered a nonessential experimental population.

The California condor is protected by the State of California under both the State Endangered Species Act and the California Fish and Game Code as a Fully Protected species. It is also listed as a Sensitive Species under California Forest Practice Rules. In September of 2018, the State of California passed legislation that allows the California Department of Fish and Wildlife (CDFW) to consider the content of any final rules under section 10(j) of the Federal Endangered Species Act for the California condor. This recently enacted legislation (AB2640) allows the Director of the CDFW to evaluate the final rule, and exempt take associated with the rule if the Director finds the Service's final rule would further the conservation of the species.

If this proposal is finalized, and we are subsequently compelled to change the California condor's NEP status to essential, threatened, all condors will be removed from the area and the experimental population rule will be revoked, unless the parties to the memorandum of understanding agree that the condors should remain in the wild. Changes in the legal status and/or removal of this population of California condors will be made in compliance with any applicable Federal rulemaking and other procedures.

The California condor is one of seven New World vultures in the Cathartidae family and the only extant species in the genus Gymnogyps (Amadon 1977, pp. 413-414; Johnson et al. 2016, pp. 193, 197). It is the largest of the North American vultures and the largest soaring land bird on the continent with a wingspan of approximately 9.5 feet (ft) (2.9 meters (m)) (Koford 1953, p. 3; Finkelstein et al. 2015, Introduction, Appearance). Males weigh slightly more than females (average weight of 19.4 pounds (lb) (8.8 kilograms (kg)) for males and 17.9 lb (8.1 kg) for females), but otherwise there are no obvious differences in coloration or morphology between the sexes (Finkelstein et al. 2015, Appearance). California condors exhibit age-related coloration changes (Koford 1953, p. 5; Snyder and Snyder 2000, pp. 14-19). Adults have black feathers except for prominent white underwing linings and edges of the upper secondary coverts. The head and neck of adults are mostly naked and range in color from yellowish to reddish orange on the head to gray, yellow, orange, and red on the neck (Koford 1953, pp. 4-5). The heads of juveniles up to 3 years old are grayish-black, and their wing linings are variously mottled or completely dark (Koford 1953, p. 5; Snyder and Snyder 2000, pp. 14-19). During the third year, the head develops yellow coloration, and the wing linings become gradually whiter (Snyder and Snyder 2000, pp. 15, 17). By the time individuals are 5 or 6 years of age, they are essentially indistinguishable from adults, but full development of the adult wing patterns may not be completed until 7 or 8 years of age (Snyder and Snyder 2000, pp. 15, 17; Finkelstein et al. 2015, Appearance).

As obligate scavengers ( i.e., relying entirely on dead animals for food), California condors have a number of physical and physiological adaptations that accommodate their highly specialized diet, including: (1) Large size, which is necessary to successfully compete at carcasses; (2) the ability to retain large amounts of food, which sustains individuals for extended periods between meals; (3) soaring and gliding flight and excellent eyesight, which help condors efficiently find food; (4) hooked bills, long necks, and largely naked heads, which allow condors to access muscle tissue deep within a carcass and to rip pieces of meat from a carcass, while minimizing the potential for feather fouling (a condition where feathers become soiled such that their performance is degraded); and (5) resistance to bacterial toxins, which is necessary for species that rely on carcasses (Snyder and Snyder 2005, pp. 7-31).

During the Pleistocene Epoch, the California condor was broadly distributed in North America from southern British Columbia to Baja California, and eastward throughout the southern United States and northern Mexico to Florida (Koford 1953, p. 7; Brodkorb 1964, pp. 253-254; Messing 1986, pp. 284-285; Steadman and Miller 1987, p. 423; Snyder and Snyder 2005, p. 6; D'Elia and Haig 2013, p. 17). The extent of its distribution along the east coast of North America during the late Pleistocene also extended to the boreal forests of upstate New York (Steadman and Miller 1987, pp. 416-423). The disappearance of the California condor from its prehistoric range in North America east of the Rocky Mountains occurred about 10,000-11,000 years ago coinciding with the late-Pleistocene extinction of the North American megafauna (Emslie 1987, pp. 768-770; Steadman and Miller 1987, pp. 422-425). Analysis of stable isotopes in bone collagen suggests that the California condor's persistence along the Pacific coast at the end of the Pleistocene was at least partially due to the availability of marine-derived carrion (Chamberlain et al. 2005, p. 16710; Fox-Dobbs et al. 2006, p. 688).

Historical observations of California condors indicate that they were widespread and locally abundant from southern British Columbia, Canada, to Baja California, Mexico, during Euro-American colonization (Koford 1953, pp. 8-19; Wilbur 1978, pp. 13, 72-85; Snyder and Snyder 2005, pp. 4-5; D'Elia and Haig 2013, pp. 38-59). At that time they were apparently restricted to the area west of the Rocky Mountains and were infrequently encountered east of the Cascade or Sierra Nevada mountain ranges (Snyder and Snyder 2000, p. 12; D'Elia and Haig 2013, pp. 38-59). California condor population declines and range contractions were concurrent with Euro-American settlement of the West, with condors disappearing from the Pacific Northwest in the early 1900s (D'Elia and Haig 2013, pp. 58-59), and from Baja California by the end of the 1930s (Wilbur and Kiff 1980, entire). By the middle of the 20th century, the species was reduced to about 150 individuals limited to the mountains of southern California (Snyder and Snyder 2000, pp. 81-82), and at the time we formally classified them as an endangered species in 1967, the population had further declined to an estimated 60 condors (Snyder and Snyder 2000, pp. 82-83). Most probable causes of their historical decline include: (1) Secondary poisoning from predator removal campaigns, (2) direct persecution, and (3) lead poisoning from spent ammunition that fragmented in animals condors later fed upon (D'Elia and Haig 2013, pp. 77-122).

Due to concerns over the few remaining California condors and the population's continued downward trend, beginning in 1983, we took all condor eggs from the wild to the San Diego Wild Animal Park and Los Angeles Zoo for artificial incubation to form a captive flock (Snyder and Hamber 1985, p. 378; Snyder and Snyder 2000, pp. 278-293). By taking all wild eggs and inducing multiple clutches and annual nesting, the productivity of the population was increased several fold, allowing the captive population to grow rapidly (Snyder and Hamber 1985, p. 378). However, with the sudden loss of several wild California condors in 1984 and 1985, it became necessary for us to capture the remaining wild individuals to ensure the genetic viability of the species and enhance the chances of the captive-breeding program's success (Snyder and Snyder 2000, pp. 298-304). By 1987, the California condor existed only in captivity, having suffered a severe population bottleneck and loss of genetic diversity (Ralls and Ballou 2004, p. 225; D'Elia et al. 2016, pp. 707-708). Thus, the conservation of the species was dependent upon captive breeding and releases back into the wild.

We first released captive-reared California condors in 1992 in southern California, but because of behavioral problems exhibited by these individuals we returned them all to captivity in early 1995 (Snyder and Snyder 2000, pp. 344-345). We reinitiated releases of captive-reared and formerly wild California condors in southern California in 1995, and additional release sites were established in northern Arizona in 1996, central California near Big Sur in 1997, Sierra de San Pedro Mártir in Baja California, Mexico, in 2002, Pinnacles National Park (formerly Pinnacles National Monument) in 2003, and in the mountains near San Simeon, California, in 2015. Currently, these release sites comprise four general release areas (central California, southern California, Baja California, and Arizona/Utah) in three condor populations (a population in central and southern California—where individuals from each release area occasionally intermingle—and independent populations in northern Arizona/southern Utah and Baja California). The California condor is currently absent from the northern portion of its historical range and remains reliant on the release of captive-bred individuals for population growth (USFWS 2013, p. 14).

As of December 2017, there were 290 California condors in the wild, divided among the four release areas: Central California (90 condors); southern California (80 condors); northern Arizona and southern Utah (82 condors); and the Sierra de San Pedro Mártir release site in Baja California (38 condors) (USFWS 2018, p. 1). There were also 173 California condors in captivity (USFWS 2018, p. 1) distributed among release sites, zoos, and four captive-breeding facilities. Breeding facilities include the Peregrine Fund's World Center for Birds of Prey, the Oregon Zoo's Jonsson Center for Wildlife Conservation, the Los Angeles Zoo, and the San Diego Zoo's Safari Park.

Despite population growth, the total number of wild California condors is still relatively small and the species requires intensive management for survival, including: (1) Monitoring all condors in the wild to track resource use, identify behavioral problems, and detect mortalities; (2) biannual trapping for health screening, to test blood samples for lead, inoculate for West Nile virus, and to attach or replace wing tags and transmitters; (3) taking injured or poisoned condors back into captivity temporarily to administer treatment; and (4) nest observations and interventions to maximize productivity in the wild (Walters et al. 2010, pp. 972, 976, 982-984; USFWS 2017, pp. 5-19).

Along with our conservation partners, we have reintroduced California condors to a variety of habitats, including coastal mountains, old-growth forests, desert cliffs, and temperate montane shrublands and grasslands. Within these habitats they can have enormous home ranges (Meretsky and Snyder 1992, p. 321; Hunt et al. 2007, pp. 84-87; Romo et al. 2012, pp. 43-47; Rivers et al. 2014a, pp. 496-498) and often use different portions of their range for nesting and foraging (Meretsky and Snyder 1992, p. 329; Snyder and Snyder 2000, pp. 140-147; D'Elia et al. 2015, p. 96). Home range size varied among release sites (95 percent confidence intervals for southern California: 173,295-282,760 acres (ac) (70,130-114,429 hectares (ha)); Pinnacles National Park: 86,825- 174,266 ac (35,137-70,523 ha); and Big Sur: 42,613-90,495 ac (17,245-36,622 ha)), probably as a result of geography, food availability (Rivers et al. 2014a, pp. 496-497, 500), years since the release program started, and flock size (Bakker et al. 2017, p. 100).

Nesting habitat is generally characterized by steep, rugged terrain (Wilbur 1978, p. 7; Snyder and Snyder 2000, p. 18; D'Elia et al. 2015, pp. 94-95). Within these areas, nests have been documented in various types of rock formations including crevices, overhung ledges, potholes, and in cavities or broken tops of giant sequoia ( Sequoia giganteus ) (Snyder et al. 1986, pp. 235-236) or coast redwood ( Sequoia sempervirens ) trees (Burnett et al. 2013, pp. 478-479). Breeding adults segregate themselves into nesting territories, rarely crossing into the active nesting territories of other California condors (Finkelstein et al. 2015, Behavior). California condors will generally use the same nesting territory in successive years as long as pairs remain intact, but will often switch nesting sites within that territory, regardless of whether they fail or succeed in their nesting efforts (Snyder et al. 1986, p. 236).

California condors roost communally along rocky outcrops, steep canyons, and in tall trees or snags near foraging grounds, water sources, and nests (Koford 1953, pp. 35-36; Snyder and Snyder 2000, p. 167). California condors select roosts that offer good peripheral visibility, where there is a long unobstructed space for taking off downhill and for approaching the roost in flight, and areas where there is some protection from high winds (Koford 1953, pp. 35-36). While at a roost, condors devote considerable time to preening, sunning, and other maintenance activities (Snyder and Snyder 2000, p. 24).

California condors are obligate scavengers and obligate soaring birds, making them reliant on the availability of sufficient food resources and upward air movement (Ruxton and Houston 2004, p. 434). Foraging habitats generally have high landscape productivity, moderate to steep slopes, sparse vegetation, and upward air movements necessary to keep California condors aloft (Rivers et al. 2014b, pp. 7-9; D'Elia et al. 2015, p. 96). In coastal areas condors show strong selection for beaches, likely because of the relative abundance of marine mammal carcasses (Rivers et al. 2014b, p. 8). A feature of carrion as an exclusive food resource is that dead animals are highly dispersed and ephemeral (Ruxton and Houston 2004, p. 433). This has resulted in evolutionary pressure for condors to be large, obligate soaring birds that forage socially (Ruxton and Houston 2004, p. 433). Social foraging means the population is particularly susceptible to contaminated food resources, as a contaminated carcass can poison a large number of individuals in a single feeding (Finkelstein et al. 2012, p. 11453; D'Elia and Haig 2013, p. 87).

As birds with a large wingspan that use soaring and gliding flight, California condors can move long distances while expending minimal energy (see Pennycuick 1969, pp. 542-545; Ruxton and Houston 2004, p. 435). Examples of exceptional flight distances include: California condor movements between the central and southern California flocks—a distance of approximately 150 miles (mi) (241 kilometers (km)) ( e.g., USFWS 2017, pp. 20-21); a condor released at Pinnacles National Park flying to the southern Sierra Nevada and back—a one-way distance of approximately 249 mi (400 km) (USFWS, unpublished data); a condor released in the Sierra de San Pedro Mártir in Baja California, Mexico, traveling north to San Diego County, a distance of approximately 140 mi (225 km) (Romo et al. 2012, p. 44); and observations of condors released in northern Arizona in southern Wyoming, Colorado, and New Mexico, at distances of approximately 340 mi (547 km), 400 mi (643 km), and 325 mi (523 km), respectively. In addition, GPS telemetry data is now revealing that California condors in southern California are beginning to regularly travel 93-124 mi (150-200 km) away from core use areas (USFWS unpublished data). As the populations continue to grow, the number of long-distance flights is likely to increase.

To date, nests have been concentrated in a relatively limited area around release sites when compared to exceptional flight distances. The farthest nest documented from release sites in each release area is approximately 47 mi (76 km) in central California, 57 mi (92 km) in southern California, 62 mi (100 km) in Arizona/Utah, and 15 mi (24 km) in Baja California. We expect that as flock size grows the population will continue to expand and nest sites will eventually be located farther from release sites.

Based on the California condor's fidelity to nesting territories, their social foraging behaviors, and our monitoring of current populations, we do not expect major geographic shifts in the breeding populations. The California condor's long nesting period coupled with extended dependency of chicks on adults also precludes latitudinal migration in the breeding population (D'Elia and Haig 2013, pp. 61-75). However, seasonal shifts in movements to foraging grounds occur with changes in food availability, and perhaps as a result of social factors ( e.g., traditional movements) (Meretsky and Snyder 1992, p. 328; Snyder and Snyder 2000, pp. 145-147; Hunt et al. 2007, pp. 85-87). Seasonal changes in daylight hours and the availability of thermals for soaring mean that home ranges can be up to 5-6 times larger in the late summer and early fall compared to late fall and early winter (Rivers et al. 2014a, pp. 497, 499).

Breeding California condors form pairs in late fall or early winter and visit various potential nest sites within their nesting territory in January and February (Finkelstein et al. 2015, Breeding). Once pairs are formed they tend to stay together year-round for multiple years until one member of the pair dies (Snyder and Snyder 2000, p. 19). However, the death of one member of a pair can trigger a chain reaction with multiple pairs switching mates. This situation can occur because each California condor that loses its mate represents a potentially more desirable mate to individuals of lower rank in the social hierarchy of the flock. Breeding California condors lay a single egg between late January and early April (Finkelstein et al. 2015, Breeding). The egg is incubated by both parents and hatches after approximately 53-60 days (Snyder and Snyder 2000, p. 19). California condor pairs that lose their egg early in the breeding season (February through mid-April) will generally lay a replacement egg (Snyder and Hamber 1985, p. 377). When a replacement egg is lost, it has occasionally been followed by a third egg (Finkelstein et al. 2015, Breeding).

Both parents share responsibilities for feeding the nestling (Snyder and Snyder 2000, p. 19). Feeding, via regurgitation, usually occurs daily for the first 2 months, then gradually diminishes in frequency (Snyder and Snyder 2000, p. 197). As early as 6 weeks after hatching, California condor chicks leave the nest cavity but remain in the vicinity of the nest where they are fed by their parents (Snyder and Snyder 2000, p. 201). The chick takes its first flight at about 5.5 to 6 months of age, but does not become fully independent of its parents until the following year (Snyder and Snyder 2000, pp. 201-202). Parents occasionally continue to feed a fledgling even after it has begun to make longer flights to foraging grounds (Koford 1953, p. 103; Snyder and Snyder 2000, pp. 202-203).

Because of the long period of parental care, it was formerly assumed that successful California condor pairs normally nested successfully every other year (Koford 1953, pp. 22-23). However, this pattern varies, depending mostly on the time of year that the nestling fledges. If a nestling fledges relatively early (in late summer or early fall), its parents may nest again in the following year, but late fledging inhibits nesting in the following year (Snyder and Hamber 1985, pp. 377-378; Snyder and Snyder 2000, p. 19).

Once independent, juvenile California condors often associate with one another on the foraging grounds and join adults and other juveniles at communal roosts (Finkelstein et al. 2015, Breeding). In a study of the remnant wild population in southern California (1982-1987), Meretsky and Snyder (1992, pp. 324-325; 329-330) found that California condors in their first 2 years after fledging were generally limited to natal nest areas and foraging areas relatively close to natal nest areas, while older juveniles would forage more widely and visit additional non-natal nesting territories and it was not until age 4 or 5 that condors were capable of visiting virtually all foraging and nesting areas within a given population. However, more recent data from the reintroduced populations shows that fledglings under 1 year of age can be fully integrated into the flock, foraging hundreds of miles from natal or release areas and by 2 years of age are capable of covering the flock's entire range (USFWS, unpublished data). This difference between the remnant wild population in the 1980s and the current populations is likely a product of the larger size of the current population, and the larger number of older California condors that are available to serve as mentors to recently fledged condors.

California condors are long-lived birds. In captivity, they can live more than 50 years. Average age of first breeding is 8 years and 6 months for females and 9 years and 10 months for males (Mace 2017, pp. 240, 243). The oldest known breeding female was 38 years old (Mace 2017, p. 239).

Slow maturation and low reproductive rates in California condors demand low mortality rates for the population to be stable or to grow (Mertz 1971, p. 448; Verner 1978, pp. 19-21; Meretsky et al. 2000, pp. 960-961). Population demographic models indicate that annual adult mortality rates certainly must average <10 percent annually to achieve stable or increasing populations (Verner 1978, pp. 19-21; Meretsky et al. 2000, p. 961), and likely need to be <5 percent (Meretsky et al. 2000, p. 961; Cade 2007, p. 2129; Woods et al. 2007, p. 65; Walters et al. 2010, p. 974). Estimates of mortality rates in the first decade of the release program in California and Arizona—when individuals treated for lead poisoning were considered mortalities—were between 17-35 percent, greatly exceeding the mortality rates needed for a self-sustaining stable population (Meretsky et al. 2000, p. 963). Currently, populations in the wild are only viable as a result of augmentation through ongoing captive-breeding and release efforts, in concert with intensive monitoring and management to reduce mortality (Green et al. 2008; Finkelstein et al. 2012, p. 11452; USFWS 2013, pp. 27-30).

The primary threat to the viability of the California condor is lead poisoning from spent ammunition left in gut-piles or carcasses of animals that condors feed upon (Meretsky et al. 2000, p. 963; Church et al. 2006, p. 6148; Cade 2007, entire; Woods et al. 2007, pp. 73-75; Green et al. 2008, p. 9; Walters et al. 2010, pp. 993-994; Finkelstein et al. 2012, pp. 11452-11453; Rideout et al. 2012, pp. 108-109; Kelly et al. 2015, pp. 395-398; Bakker et al. 2017, pp. 101-103). Without intensive management of the impacts from this threat, which includes periodic trapping for health exams, monitoring blood lead levels, and treatment if necessary, the wild populations would trend toward extinction (Woods et al. 2007, p. 65; Green et al. 2008, pp. 8-9; Walters et al. 2010, pp. 993-994; Finkelstein et al. 2012, pp. 11452-11453). In the absence of this threat, California condor populations would likely grow and become self-sustaining, without the need for intensive management (Woods et al. 2007, p. 65; Green et al. 2008, p. 9; Finkelstein et al. 2012, pp. 11452-11453).

Several laws and voluntary programs to reduce the threat from lead ammunition have been enacted. The State of California instituted a restriction on the use of lead ammunition for hunting within the range of the California condor in southern and central California in July 2008 (Ridley-Tree Condor Preservation Act 2008, entire). The geographic and regulatory scope of this restriction was expanded with Assembly Bill 711 (AB711) that was signed into law in October 2013. AB711 amended section 3004.5 of the California Fish and Game Code, relating to hunting. The law, which restricts the use of lead ammunition for taking wildlife, is currently being phased in, with a full State-wide ban for all take of wildlife by 2019. In addition to these laws, voluntary lead reduction programs are in place in California, Oregon, Arizona, and Utah; while these voluntary programs vary by State, actions under these programs have included: (1) Surveys to understand attitudes toward lead reduction, (2) outreach to hunters at sportsman shows and in the field, (3) coordination with hunter constituency groups, and (4) targeted vouchers for free non-lead ammunition (Sieg et al. 2009, pp. 344-345; Chase and Rabe 2015, pp. 2-3; AGFD 2017, web page, UDWR 2017, web page, ODFW 2017, web page; Huntingwithnon-lead.org 2017, web page).

Other threats to California condors include: Rangeland conversion, wind energy development, collision with and electrocution from powerlines, predation, disease, inadequacy of existing regulatory mechanisms, shooting, microtrash ingestion, organochlorine pesticides, and habituation to humans. A full description of these threats, and efforts to abate them, are provided in our most recent status review for the California condor (USFWS 2013, entire).

We published a California condor recovery plan in 1974 (USFWS 1975, entire), and revised the plan in 1980 (USFWS 1980, entire), 1984 (USFWS 1984, entire), and 1996 (USFWS 1996, entire). To date, recovery efforts have focused on reintroduction and recovery in the southern portion of the species' historical range (see Captive Breeding and Reintroduction Efforts, above). Recovery criteria for removing the California condor from the endangered species list were not provided in the 1996 revision to the recovery plan, as its primary focus was keeping the species from going extinct. At the time the revised recovery plan was written, there were only 17 California condors in the wild (USFWS 1996, p. 9) and we could not anticipate at that time all actions that would be necessary for full recovery. The overall strategy for recovery outlined in the 1996 recovery plan was to focus on: (1) Increasing reproduction in captivity to provide condors for release, (2) the release of condors to the wild, (3) minimizing condor mortality factors, (4) maintaining habitat for condor recovery, and (5) implementing condor information and education programs (USFWS 1996, p. 21). While the recovery plan did not have delisting criteria, it included as criteria for reclassifying (or downlistng) to a threatened species an objective of establishing at least two, preferably more, self-sustaining disjunct wild populations in order to reduce the risks to the overall population and to facilitate genetic and demographic management (USFWS 1996, p. 24).

The 1996 revised recovery plan does not provide specific recovery targets or actions for the Pacific Northwest, but our 1980 recovery plan recommended surveys of Oregon, Washington, and California to identify potential habitat for future releases into unoccupied portions of the historical range (USFWS 1980, p. 50). Recent habitat modeling has revealed large areas of potentially suitable nesting, roosting, and feeding habitats in the Pacific Northwest (D'Elia et al. 2015, pp. 95-96). Although criteria for full recovery were not provided in our latest recovery plan revision (USFWS 1996, entire), increasing the global population of the California condor and expanding its geographic distribution among the ecosystems it once occupied are, on first principles, consistent with efforts to recover the species.

An existing population model based on published demographic rates (Bakker et al. 2017, entire) was used to simulate State-wide California condor population growth in California over the next 30 years (2018-2048), assessing scenarios with and without the allocation of some of the available captive-bred individuals, to a new geographically disjunct flock (Bakker and Finkelstein 2018, entire). These model simulations demonstrate that allocating captive-bred individuals to a new, geographically disjunct flock, which is expected to have lower survival and reproduction compared to the existing flocks, would reduce the population growth of condors in California. Under the scenarios where the total number of chicks distributed currently remains approximately equal to current levels, this effect would increase as the ratio of releases allocated to the new flock versus the existing flock increases. Model simulations reinforce the importance of increasing captive chick production and releases to the wild. The number of chicks produced in the captive program and released to the wild has been variable over time, but continues to drive population growth in the wild due to the high chick and juvenile survivorship attainable in a captive setting and to ongoing mortality in the free-flying population combined with the long generational gap between chick stage and breeding age (approximately 6-8 years) in California condors (Finkelstein et al. 2012, entire; Bakker et al. 2017, entire; Bakker and Finkelstein 2018, entire).

The California Condor Recovery Program is currently proposing to increase the number of captive-produced condors for release into the wild, and would continue to allocate the number of chicks to each release site necessary to maintain positive population growth at each site, to the extent practicable. Continuing to grow the wild population of California condors while reestablishing them in an unoccupied portion of their historical range is consistent with our overall strategy to recover the species.

In summary, a NEP in the Pacific Northwest would establish an additional population in the United States, beyond the minimum of two populations envisioned for downlisting to a threatened species. This would contribute to the conservation of the species by: Further reducing the risk that any one catastrophic event would affect a large proportion of the species (increasing the population redundancy); increasing the global population of the species (increasing resiliency); and expanding the geographic distribution of the species among ecosystems (increasing representation by expanding the ecological settings in which the species occurs).

When we establish experimental populations under section 10(j) of the Act, we must determine whether such a population is essential to the continued existence of the species in the wild. Although the experimental population will contribute to the recovery of the California condor, it is not essential to the continued existence of the species in the wild. California condors are currently distributed among three disjunct and intensively managed populations in California, Arizona and Utah, and Baja California, Mexico. Management at these sites includes: Monitoring individuals with VHF or GPS/GSM transmitters; biannual trapping for health screenings; vaccination for West Nile virus; aversive conditioning to power poles prior to release; chelation therapy to treat California condors with elevated blood-lead levels; and nest observations, entries, and interventions to maximize productivity in the wild (Walters et al. 2010, pp. 972, 976, 982-984; Romo et al. 2012, pp. 28-56; Southwest Condor Review Team 2017, pp. 4-21; USFWS 2017, pp. 5-19). In addition, there are ongoing releases of captive California condors into each of the wild populations. Releases are carefully coordinated among sites to ensure a healthy age structure, sex ratio, and distribution of founder genomes (Ralls and Ballou 2004, pp. 221-225). As a result of these efforts, the populations of wild California condors continue to grow (USFWS 2018, p. 6).

In addition to the three wild populations, there is also a sizable captive population at four breeding facilities, which are widely distributed in California, Oregon, and Idaho (see Biological Information, above). The breeding facilities are secure facilities, not open to the public, where California condors are kept under 24-hour surveillance by condor keepers or video cameras. The captive population is given extensive care, and deaths and injuries are rare, with a captive annual survival rate after the first month of life of 0.989 percent (95 percent confidence interval: 0.984-0.992) (Bakker et al. 2017, p. 97). In addition, the geographic separation of the four breeding facilities protects the captive population from the threat of extinction due to a single catastrophic event.

The captive population was formed with only 13 apparent genetic founders that comprised three genetic clans (Geyer et al. 1993, p. 573; Ralls and Ballou 2004, p. 219; Pryor and Ralls 2016, p. 3). Genetic management, which includes control of all captive matings, has been implemented to minimize the loss of remaining genetic diversity and ensure this remaining genetic diversity is well distributed among the captive-breeding facilities and reintroduction sites (Ralls et al. 2000, p. 152; Ralls and Ballou 2004, p. 226; Pryor and Ralls 2016, p. 2). California condors released within the proposed experimental population would come from a mixture of the founder clans represented in the captive population and would not represent a unique genetic lineage of California condors. Therefore, loss of this population would not represent a substantive change in the genetic diversity or genetic viability of the worldwide population of California condors.

The proposed reintroduction project will further the recovery of the California condor by attempting to establish another wild population in an unoccupied portion of the species' historical range. However, for the reasons stated above, California condors released into the Pacific Northwest are not essential to the survival of the species in the wild. Therefore, as required by 50 CFR 17.81(c)(2), we find that the proposed experimental population is not essential to the continued existence of the species in the wild, and we propose to designate the experimental population in the Pacific Northwest as a nonessential experimental population (NEP).

Section 10(j) of the Act requires that an experimental population be geographically separate from wild populations of the same species. Considering a number of factors (as described in detail, below), we drew the NEP area to include a portion of northern California, northwestern Nevada, and all of Oregon. The western boundary of the NEP is the Submerged Lands Act boundary line along the Pacific coast. The southern boundary of the NEP is formed by an east-west line from California's Submerged Lands Act boundary to Hare Creek; Hare Creek from the Pacific Ocean to its junction with California State Route 1; north to the junction of State Route 1 and State Route 20; east along California State Route 20 to where it meets Interstate 80; and Interstate 80 from its intersection with California State Route 20 to U.S. Route 95 in Nevada. The eastern boundary of the NEP is U.S. Route 95 in Nevada to the State boundary of Oregon and then east and north along Oregon's southern and eastern boundaries, respectively. The northern boundary of the NEP is the northern State boundary of Oregon. All highway boundaries are inclusive of the entire highway right of way. See map below and in the Environmental Assessment (NPS et al. 2018, Figure 2, p. 5)

The last California condor specimen collected within the proposed NEP area was in 1892 along Yager Creek in Humboldt County, California (Smith 1916, p. 205; D'Elia and Haig 2013, pp. 39-46). Although there were a few reported California condor sightings up to 1925 in the area we are proposing to designate an NEP, since then there have been no credible sightings of condors in the wild in this area—or anywhere north of San Francisco (D'Elia and Haig 2013, pp. 58-59). Given that all released California condors are actively tracked with radio or GPS/GSM transmitters, we are confident that there are no wild condors in the proposed NEP.

The location of the proposed reintroduction site is the Bald Hills of Redwood National Park, an area proximal to suitable nesting and feeding habitat. Ten potential release sites were identified by the Yurok Tribe, and the proposed release site was selected following careful consideration of site suitability, logistics, threats and hazards, cultural resources, and suitability of adjacent lands (Yurok Tribe Wildlife Program, pers. comm. 2016). The proposed release site would be situated in grassland habitat above a redwood forest with sufficient topography to allow young California condors to more easily achieve flight. Redwood forests in the vicinity of the release site, as well as proximal mountain ranges (Oregon Coast Range, Klamath-Siskiyou Mountains, and the Northern Coast Range in California) are expected to provide ample roosting and nesting habitat. Inland valleys and mountaintop prairies, in conjunction with a proximal coastline, are expected to provide a mixture of sufficient terrestrial and marine feeding areas and food resources. Landscape-scale models indicate that the amount and characteristics of habitat in the region compare favorably to other portions of the historical range (D'Elia et al. 2015, pp. 95-96).

In defining the experimental population boundary, we attempted to encompass the area where the population is likely to become established in the foreseeable future. For the purposes of this proposed rule, we define the foreseeable future as approximately 20 years. This time horizon was based on our ability to reasonably forecast population expansion given the number of years of data we have on California condor movements from release sites in southern and central California (22 years in southern California and 20 years central California). We expect that the relative contribution of the experimental population toward recovery of the California condor will be evident during this time span, although we recognize that establishing a self-sustaining population of condors in the region may take longer given the species' extremely low reproductive rates. We may draw our experimental population boundary large enough to account for expansion over time as the introduced population begins to breed in the wild, and to assist in identifying any individuals belonging to the NEP. When possible, we use recognizable features on the landscape, legal land descriptions, or administrative boundaries to demark experimental population boundaries. We are proposing to include the entire State of Oregon to ensure that any California condors originating from the releases at Redwood National Park and flying north into Oregon are recognized as members of the NEP and are covered by the NEP regulations.

Information we considered in drawing our NEP boundary included California condor movement data from existing release sites, and the location of the closest existing condor population, as well as input from State wildlife agencies. Movement data indicate that, after 20 years of releasing California condors, most individuals remain within approximately 124 mi (200 km) of the release site—although exceptional flight distances occasionally occur and the existing populations continue to expand as flock size increases. The closest California condor release site to the proposed release site is at Pinnacles National Park, approximately 350 mi (563 km) to the south. The proposed release site is approximately 124 mi (200 km) from the nearest edge of the experimental population boundary; and the southern edge of the experimental population boundary is approximately 112 mi (180 km) from the northern extent of the closest endangered population of California condors. Thus, the proposed southern boundary of the NEP approximates a mid-point between the nearest population in central California and the proposed release site at Redwood National Park. The farthest documented nesting pair of California condors from any release site since the inception of the captive-breeding program was approximately 62 mi (100 km), while most nests are within 47 mi (75 km) of their release site of origin. Given our definition of foreseeable future and the information from existing release sites, we anticipate that the small number of California condors initially released at Redwood National Park—with the exception of occasional exceptional flights—would remain within the experimental population boundary over the first 20 years of reintroductions.

If a reintroduction of California condors in northern California is successful, it is possible that some individuals from the NEP may eventually move outside of the NEP area. It is also possible that California condors from the other California release sites may enter the proposed NEP. We expect that these movements, if they occur, would be infrequent in the foreseeable future given the size of the NEP, the NEP's distance from existing populations, and observed California condor movements at other release areas over the last two decades. Furthermore, we find that the interaction of individuals among the NEP and existing endangered populations, and the merging of these populations are even more unlikely to occur in the foreseeable future given the distance between the populations and the small number of California condors likely to occupy the NEP. Even if California condors occasionally moved into or out of the proposed NEP, the presence of one or a few individual dispersing condors would not constitute a “population” and any individuals dispersing into or out of the experimental population area would be treated as if they were part of the population at the location where they are found ( See Wyoming Farm Bureau Federation v. Babbitt, 199 F.3d 1224, 1234-6, FN 5 (10th Cir. 2000) (finding the Secretary reasonably exercised his management authority under section 10(j) in defining the experimental wolf population by location). Based on definitions of “population” used in other experimental population rules ( e.g., 59 FR 60252, November 22, 1994 (gray wolves), 71 FR 42298, July 26, 2006 (Northern aplomado falcons)), we consider a population to require a minimum of two successfully reproducing California condor pairs over multiple breeding cycles. Using this definition of a population, the best available information suggests that the population of California condors formed from releases in Redwood National Park is likely to be wholly separate from other populations of California condors for the foreseeable future.

The best available scientific data indicate that the reintroduction of California condors into suitable habitat in Redwood National Park is biologically feasible and would promote the conservation of the species. Along with our numerous recovery partners, we have over 25 years of experience breeding and releasing California condors into the wild at several release areas across various ecosystems. Release techniques are well established, as are protocols for managing released California condors. Based on our collective knowledge gained from these efforts, we anticipate California condors will become successfully established for the following reasons:

(1) Landscape-scale modeling indicates the NEP may have some of the most extensive nesting, roosting, and feeding habitats remaining within the historical range in California, Oregon, and Washington (D'Elia et al. 2015, pp. 95-97). California condors are habitat generalists and have been successfully reintroduced to variety of ecosystems including the mountain foothill of southern California, coastal forests of central California, high desert and canyon lands in northeastern Arizona and mountainous areas in Baja California, Mexico. This species is flexible in its diet, eating carrion of many different species of wildlife and livestock. Therefore, we do not anticipate climate change effects on habitat will negatively impact our ability to re-establish a population of this species in the Pacific Northwest.

(2) A site-specific habitat evaluation, which considered site suitability, logistics, threats and hazards, cultural resources, and suitability of adjacent lands, found the release site to have suitability ratings similar to existing release sites (Yurok Tribe Wildlife Program, pers. comm. 2016).

(3) The causes for California condor extirpation from the region are either no longer active or are being addressed through a mixture of regulatory and proactive voluntary conservation measures (see Addressing Causes of Extirpation, below).

(4) The extent of effects of existing and proposed actions and activities within the NEP on the reintroduced population have been evaluated in an environmental assessment and are compatible with conservation of the California condor (NPS et al. 2018, entire).

(5) The reintroduced population will receive ongoing demographic support from a managed captive population and an active field monitoring and management program (Similar population support has allowed population growth and establishment at all of the other California condor release sites).

(6) The reintroduced population will be integrated with the California Condor Recovery Program to ensure that California condors released in Redwood National Park have an appropriate sex ratio, age-structure, and include representatives of the founder genomes.

(7) There is broad institutional and partner support for a California condor reintroduction in Redwood National Park and Yurok ancestral territory.

On June 14, 2016, a Memorandum of Understanding (MOU) between 16 parties was finalized. The purpose of the MOU was to formalize an agreement to assess the potential to recover California condors in the Pacific Northwest and to work to seek funding to support that effort if it proved feasible. Signatories to the MOU included the U.S. Fish and Wildlife Service, National Park Service (NPS), Bureau of Land Management, Yurok Tribe, California Department of Fish and Wildlife (CDFW), California Department of Parks and Recreation (CDPR), Oregon Department of Fish and Wildlife (ODFW), Oregon Zoo, Sequoia Park Zoo, Ventana Wildlife Society, Oakland Zoo, Pacific Gas and Electric Company, Pacific Power Company, Green Diamond Resource Company, and Hells Canyon Preservation Council. In 2018, the U.S. Forest Service, also signed this MOU. Based on all of these considerations, we anticipate that reintroduced California condors are likely to become established and persist within the NEP.

Investigating the causes for decline and extirpation of California condors is necessary to understand whether the threats have been sufficiently curtailed such that reintroduction efforts are likely to be successful. Evaluation of various hypotheses for the extirpation of California condors in the Pacific Northwest revealed that secondary poisoning related to predator control and extermination campaigns, direct persecution, and possibly lead poisoning from spent ammunition were the primary causes (D'Elia and Haig 2013, pp. 119-122). Two of these primary drivers of regional extirpation—predator poisoning and direct persecution—are no longer the primary threats to the California condor. According to the most comprehensive assessment of California condor deaths from 1992 through 2009, of the 76 deaths where a definitive cause was determined, there were no confirmed cases of secondary poisoning related to predator control (although there was one possible case involving glycol toxicosis) and only five cases of condors directly persecuted by gunshot or arrow (Rideout et al. 2012, pp. 108, 110).

Based on multiple lines of evidence, the primary threat to the recovery of the California condor is lead poisoning from spent ammunition (see Biological Information, above). Regulations banning lead ammunition for taking wildlife in California will be in effect by the time of the reintroduction effort (see Biological Information, above). In addition, voluntary efforts to reduce lead exposure in wildlife are ongoing in Oregon (see Biological Information, above). Finally, the reintroduction program will carefully monitor the population and conduct regular health checks to evaluate whether reintroduced California condors are being exposed to lead, the rate of exposure, and how this situation compares to other portions of the species' range. When necessary, California condors with elevated lead levels will be treated for lead poisoning. While the threat from lead ammunition is still present in the proposed experimental population area, it is being addressed through a mixture of regulatory and proactive voluntary measures (see Biological Information, above); therefore, we will not request further regulation of lead ammunition for this proposed experimental population. Sources of mortality will be carefully monitored, and if high mortality rates are preventing the establishment of a self-sustaining population, we will work with our conservation partners to implement additional voluntary measures to address threats, as we have at other California condor release sites.

Release procedures at Redwood National Park are described in the environmental assessment (NPS et al. 2018, pp. 23-28) and would be similar to those at existing release sites. Procedures include: (1) The use of an onsite release pen where California condors are kept for a short period of time prior to release, (2) tracking of all released condors via telemetry (VHF and GPS/GSM), and (3) supplying condors with proffered food at the release site to allow for repeated trappings to monitor health and replace transmitters.

In general, a new cohort of captive-reared California condors will be released annually. The size of each release group will depend on the number of California condors in captivity available for release, but annual releases will likely involve up to six condors. California condors hatched in captivity will be raised by their parents or a condor look-alike hand puppet until they are approximately 6 months to 1 year old. They will then be placed with other California condors in a single large pen so they will form social bonds and undergo aversion training to power poles. The young California condors will be transported to the release site at Redwood National Park when they are approximately 1.5 to 2 years old. At the release site they will be placed in a flight pen and will remain there for an acclimation period of approximately 3 months.

Biologists will remain near the release pen, observing the young California condors' behavior and guarding against predators or other disturbance. After the initial adjustment period, California condors will be released from the flight pen. Any release candidate showing signs of physical or behavioral problems will not be released. A small area of NPS land will be closed to recreational activity to protect the California condors in or around the release facility. Carcasses will be provided at the release site, as supplemental food for newly released California condors, and as necessary, to attract condors for periodic trapping to check their health and swap-out transmitters.

All California condors released to the wild will be marked to allow identification of individuals. Current methods for doing this include placing electronic transmitters ( e.g., GPS/GSM and radio transmitters) and wing markers on the wings of each California condor. The movements and behavior of each California condor will be monitored remotely using electronic transmitters and ground observations. Aerial tracking will be used to find lost individuals, and telemetry flights will be coordinated with the appropriate land management agencies. Our methods for identifying and monitoring individuals will be adaptive and may change as technology improves.

An effort will be made to maintain an even sex-ratio across a range of age-classes in the released population. Adult California condors unfit for release may be transported to the release site and kept in the pen as mentors for the acclimating cohort. Adjustments will be made in release cohort structure annually based on availability from captive-breeding facilities, genetics, sex-ratio, and age.

The donor population for the proposed reintroduction of California condors to Redwood National Park is the captive population of California condors. Although the captive population is located at four breeding facilities, these facilities cooperate to manage the entire wild population and captive population as a single entity, exchanging California condors and condor eggs among the facilities as necessary for population and genetic management (Ralls and Ballou 2004, p. 216).

As of December 2017, there were 173 California condors in captivity, and the size of the captive population has been relatively stable over the last 5 years, with end-of-year counts ranging from 167 to 193 during this time period (USFWS 2018, pp. 1, 6). With the assistance of the captive-breeding program, the total population of California condors increased from 370 condors in 2010 to 463 condors in 2017 (USFWS 2018, p. 6).

The donor population is carefully managed to ensure its long-term viability. Annual reviews of breeding, captive pairings, genetic health, and demographic factors are undertaken to ensure that captive-releases will not be detrimental to the stability of the captive flock. In addition, the captive-breeding program has capacity to pair additional captive California condors to increase reproductive output as they become available for breeding and to replace senescent condors. This could be done through multiple clutching, the use of non-breeding adults to serve as foster parents, and/or puppet rearing. Given the careful management of the donor population, the ability to increase its productivity, and the relatively small number of California condors that will be released at Redwood National Park annually, impacts to the donor population are expected to be negligible.

The Service, NPS, and the Yurok Tribe will plan and manage the reintroduction of California condors at Redwood National Park. In addition, these agencies will carefully collaborate on releases, monitoring, coordination with landowners and land managers, public awareness, and other tasks necessary to ensure successful reintroduction of the species. A few specific management considerations related to the experimental population are addressed below.

(a) Incidental Take: Experimental population special rules contain specific prohibitions and exceptions regarding the taking of individual animals. These special rules are compatible with most routine human activities in the expected reestablishment area. Section 3(19) of the Act defines “take” as “to harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect, or to attempt to engage in any such conduct.” “Incidental take” is further defined as take that is incidental to, and not the purpose of, the carrying out of an otherwise lawful activity. If we adopt the 10(j) rule as proposed, most incidental take of California condors within the experimental population area would be allowed, provided that the take is unintentional and not due to negligent conduct. With the exception of fuels treatment activities by Federal and State agencies to reduce the risk of catastrophic wildfire, habitat alteration ( e.g., removing trees, erecting structures, altering the nest structure or perches near the nest) or significant visual or noise disturbance ( e.g., tree felling, chainsaws, helicopter overflights, concrete cutters, fireworks, explosives) within 656 ft (200 m) of an active nest that result in incidental take of California condors would be prohibited. Activities such as livestock grazing and use of existing roads and trails would not be considered a significant visual or noise disturbance. For the purposes of this rule, an active California condor nest is defined as a nest that is: (1) Attended by a breeding pair of condors, (2) occupied by a condor egg, or (3) occupied or attended by a <1-year-old condor.

The 656-ft (200-m) buffer is meant to serve to minimize visual and auditory impacts associated with human activities near nest sites. We chose a 656-ft (200-m) buffer after considering buffer distances used for other raptors, which varied widely from 162-5,249 ft (50-1,600 m) (Richardson and Miller 1997, pp. 635-636; Romin and Muck 2002; USFWS 2007, p. 13), as well as past recommendations on buffer distances for California condor nests, which ranged from 0.5-1.5 mi (0.8-2.4 km) (Carrier 1973, pp. 71-73). This variation is likely the result of differences in environmental setting, species-specific responses, status of the species at the time of the recommended buffer, the nature of the disturbance, and the purpose of the buffer. It is important to note that historical California condor buffer distances of 0.5 to 1.5 mi (0.8-2.4 km) were based on anecdotal observations of a small number of condor nests in a declining population, and were necessarily conservative given the context of a nearly extinct species. The nest buffer we are proposing is smaller than those earlier recommendations because of new information suggesting that nesting California condors may be more tolerant of disturbance than previously believed (see below). We also accounted for the fact that we are proposing this population as nonessential experimental. Therefore, our buffer distance around nests may be less conservative than our recommended buffer distances from nests where California condors are listed as endangered.

While species-specific responses to disturbance have not been formally studied for the California condor, observations in the 1950s and 1960s found that once a condor nest is started, it will not be abandoned unless the egg or chick is lost or the parents killed (Sibley 1969, p. 8). In addition, recent observations have documented successful nests within 0.5 mi (0.8 km) from active oil and gas operations and within 656 ft (200 m) of busy highways, hiking trails, and forestry practices such as operating chainsaws and chippers (A. Welch, NPS, pers. comm. 2015). One nest in a giant sequoia tree was successful despite being “right on the edge” of a clearcut operation (which ceased only 3 weeks prior to egg laying) and only about 656 ft (200 m) from, and in direct view of, an intermittently active dirt road (Snyder et al. 1986, p. 238).

Although the best available information suggests that California condors may not be as susceptible to disturbance as we thought in the 1960s-1980s, flushing of condors from nests has been documented due to disturbance and this activity has the potential to result in the egg breaking if the adult that is flushed is incubating the egg (Sibley 1969, p. 8). It is also possible that prolonged or repeated disturbances may cause nest failure (Sibley 1969, p. 15). To minimize the chances of nest or egg destruction and to preserve the structural integrity of habitat around nests while minimizing impacts to stakeholders, we are proposing to prohibit habitat alteration or significant visual or noise disturbance within 656 ft (200 m) of active nests. However, fuels treatments by Federal and State agencies designed to reduce the risk of catastrophic wildfire would not be prohibited within 656 ft (200 m) of active nests given the anticipated long-term conservation benefits to California condor nesting habitat. Other actions within 656 ft (200 m) of an active California condor nest may be permissible if they will not result in incidental take of California condors because of mitigating factors ( e.g., topography or limited duration or extent of the action); however, we recommend that persons who intend to take an action within this distance of an active California condor nest first contact us for technical assistance.

Existing and proposed activities and land uses surrounding the park that could potentially result in incidental take include wind power, utility transmission lines, mining, commercial timber production, and ranching operations (NPS et al. 2018). As noted above in our evaluation of the likelihood of population establishment and survival, we determined that the extent of effects of these activities within the NEP is compatible with conservation of the California condor. We expect few restrictions on these activities because most incidental take, including take associated with lead ingestion, would be not be prohibited. Some activities, such as those associated with timber harvest or erecting structures, within 200 meters of an active nest would be prohibited, as described above. However, because (1) the number of individuals initially released would be small, (2) California condors nest only on cliffs and in large tree cavities, (3) California condors tend to nest in less accessible and remote areas, and (4) the nests would be dispersed rather than concentrated in a particular area, we expect impacts to existing and proposed activities to be minimal (NPS et al. 2018). For the reasons stated above, it is unlikely that a condor would nest within areas with active timber harvest operations, as only about 0.5 percent of harvestable timber on private lands within the study area are likely to contain suitable nesting trees. (NPS 2018). Once the condor chick has fledged, activities could resume, so any prohibitions on activities would be temporary in nature.

(b) Interagency Consultation: For purposes of section 7 of the Act, section 10(j) of the Act and our regulations (50 CFR 17.83) provide that nonessential experimental populations are treated as species proposed for listing under the Act except on National Park System and National Wildlife Refuge System lands, where they are treated as threatened species for the purposes of section 7 of the Act.

(c) Special Handling: USFWS, NPS, California Department of Parks and Recreation, CDFW, ODFW, Nevada Department of Wildlife (NDOW), and Yurok Wildlife Department employees, and authorized agents acting on their behalf, may handle California condors for scientific purposes; to relocate or haze California condors to avoid conflict with human activities; for recovery purposes; to aid sick or injured California condors; and to salvage dead California condors. However, non-Service or other non-authorized personnel will need to acquire permits from the Service and the appropriate State or Tribal agency for these activities.

(d) Public Awareness and Cooperation: During January 2017, in cooperation with the Yurok Tribe and Redwood National Park, we conducted five NEPA scoping meetings on this proposed action in northern California and Oregon. We notified a comprehensive list of stakeholders of the meetings including affected Federal and State agencies, Native American Tribes, local governments, landowners, nonprofit organizations, and other interested parties. The comments we received were included in the formulation of alternatives considered in the NEPA process, and were considered in formulating this proposed regulation to designate the reintroduced California condors as an NEP.

In cooperation with conservation partners, we will monitor movements, habitat use, and survival of all released California condors (NPS et al. 2018, pp. 23-28). Monitoring individual movements will allow field staff to identify potential problem-behaviors and to capture, relocate, or haze individual California condors for their safety. It will also allow us to detect any California condors that move outside of the experimental population area. Trapping will occur at the release site to allow for hands-on physical exams of individuals, replacement of faulty or aging transmitters, marking growing feathers, sampling feathers marked previously for lead history construction, and drawing blood for immediate testing of circulating blood lead levels and laboratory analysis for other contaminants of interest including, but not limited to, organophosphates and anticoagulant rodenticides.

Annual reports that summarize monitoring and management activities will be collaboratively developed by the Yurok Tribe, NPS, and USFWS. We will evaluate the reintroduction program to determine whether to continue or terminate reintroductions every 5 years as part of our 5-year status review for the species.

Based on the best scientific and commercial data available (in accordance with 50 CFR 17.81), we find that releasing the California condors into Redwood National Park with the regulatory provisions in this proposed rulemaking will further the conservation of the species. The nonessential experimental population status is appropriate for the reintroduced population because we have determined that it is not essential to the continued existence of the species in the wild.

Executive Order 12866 provides that the Office of Information and Regulatory Affairs (OIRA) in the Office of Management and Budget will review all significant rules. OIRA has determined that this rule is not significant.

Executive Order 13563 reaffirms the principles of E.O. 12866 while calling for improvements in the nation's regulatory system to promote predictability, to reduce uncertainty, and to use the best, most innovative, and least burdensome tools for achieving regulatory ends. The executive order directs agencies to consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public where these approaches are relevant, feasible, and consistent with regulatory objectives. E.O. 13563 emphasizes further that regulations must be based on the best available science and that the rulemaking process must allow for public participation and an open exchange of ideas. We have developed this rule in a manner consistent with these requirements.

Under E.O. 13771 (“Reducing Regulation and Controlling Regulatory Costs”) (82 FR 9339, February 3, 2017), this rule is not a regulatory action because this rule is not significant under E.O. 12866.

Under the Regulatory Flexibility Act (as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996; 5 U.S.C. 60 et seq. ), whenever a Federal agency is required to publish a notice of rulemaking for any proposed or final rule, it must prepare, and make available for public comment, a regulatory flexibility analysis that describes the effect of the rule on small entities ( i.e., small businesses, small organizations, and small government jurisdictions). However, no regulatory flexibility analysis is required if the head of an agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. SBREFA amended the Regulatory Flexibility Act to require Federal agencies to provide a statement of the factual basis for certifying that a rule will not have a significant economic impact on a substantial number of small entities. We certify that this rule would not have a significant economic effect on a substantial number of small entities. The following discussion explains our rationale.

The areas that would be affected under this rule include the release site at Redwood National Park and areas where individual California condors are likely to disperse. Because of the regulatory flexibility for Federal agency actions provided by the NEP designation and the exemption for incidental take in the rule (with a minor exception around active nests), we do not expect this rule to have significant effects on any activities within Federal, State, or private lands within the NEP. In regard to section 7(a)(2) of the Act, the population would be treated as proposed for listing, and Federal action agencies are not required to consult on their activities, except on National Wildlife Refuges and National Park System lands, where the NEP is treated as a threatened species for the purposes of section 7 of the Act.

Section 7(a)(4) of the Act requires Federal agencies to confer (rather than consult) with the Service on actions that are likely to jeopardize the continued existence of a species proposed for listing. However, because the NEP is, by definition, not essential to the survival of the species, conferring will likely never be required for the California condor population within the NEP area. Furthermore, the results of a conference are advisory in nature and do not restrict agencies from carrying out, funding, or authorizing activities. Section 7(a)(1) of the Act requires Federal agencies to use their authorities to carry out programs to further the conservation of listed species, which would apply on any lands within the NEP areas. On National Wildlife Refuges and National Park System lands within the NEP the California condor would be treated as a threatened species for the purposes of section 7 of the Act. As a result, and in accordance with our regulations, some modifications to proposed Federal actions within National Wildlife Refuges and National Park System lands may occur to benefit the California condor, but we do not expect projects to be substantially modified because these lands are already administered in a manner that is compatible with California condor conservation.

This rule broadly authorizes incidental take of the California condor within the NEP area. The regulations implementing the Act define “incidental take” as take that is incidental to, and not the purpose of, the carrying out of an otherwise lawful activity, such as agricultural activities and other rural development, camping, hiking, hunting, vehicle use of roads and highways, and other activities in the NEP areas that are in accordance with Federal, Tribal, State, and local laws and regulations. Intentional take for purposes other than authorized data collection or recovery purposes would not be authorized. Intentional take for research or recovery purposes would require a section 10(a)(1)(A) recovery permit under the Act.

The principal activities on private property near the proposed release site are recreation, timber production, agriculture, and activities associated with private residences. We believe the presence of the California condor will not significantly affect the use of lands for these purposes because—with a minor exception around active condor nests—there will be no new or additional economic or regulatory restrictions imposed upon States, non-Federal entities, or private landowners due to the presence of the California condor (NPS, 2018). Therefore, this rulemaking is not expected to have any significant adverse impacts to activities on private lands within the NEP area.

In accordance with the Unfunded Mandates Reform Act (2 U.S.C. 1501 et seq. ):

(1) This rule would not “significantly or uniquely” affect small governments. We have determined and certify pursuant to the Unfunded Mandates Reform Act, 2 U.S.C. 1502 et seq., that, if adopted, this rulemaking would not impose a cost of $100 million or more in any given year on local or State governments or private entities. A Small Government Agency Plan is not required. Small governments would not be affected because the proposed NEP designation would not place additional requirements on any city, county, or other local municipalities.

(2) This rule would not produce a Federal mandate of $100 million or greater in any year ( i.e., it is not a “significant regulatory action” under the Unfunded Mandates Reform Act). This proposed NEP designation for the California condor would not impose any additional management or protection requirements on the States or other entities.

In accordance with Executive Order 12630, the proposed rule does not have significant takings implications. When reintroduced populations of federally listed species are designated as nonessential experimental populations, the Act's regulatory requirements regarding the reintroduced population are significantly reduced. This rule would allow for the taking of reintroduced California condors when such take is incidental to an otherwise legal activity, with a minor exception for habitat alteration and significant visual or noise disturbance within 656 ft (200 m) of active condor nests.

A takings implication assessment is not required because this rule: (1) Would not effectively compel a property owner to suffer a physical invasion of property, and (2) would not deny all economically beneficial or productive use of the land or aquatic resources. This rule would substantially advance a legitimate government interest (conservation and recovery of a listed species) and would not present a barrier to all reasonable and expected beneficial use of private property.

In accordance with Executive Order 13132, we have considered whether this proposed rule has significant Federalism effects and have determined that a Federalism assessment is not required. This rule would not have substantial direct effects on the States, on the relationship between the Federal Government and the States, or on the distribution of power and responsibilities among the various levels of government. In keeping with Department of the Interior policy, we requested information from and coordinated development of this proposed rule with the affected resource agencies in California, Nevada, and Oregon. Achieving the recovery goals for this species will contribute to its eventual delisting and return to State management. No intrusion on State policy or administration is expected, roles or responsibilities of Federal or State governments would not change, and fiscal capacity would not be substantially directly affected. The proposed rule operates to maintain the existing relationship between the State and the Federal Government and is being undertaken in coordination with the States of California, Nevada, and Oregon. We have cooperated with CDFW, the NDOW, and ODFW in the preparation of this proposed rule. Therefore, this proposed rule does not have significant Federalism effects or implications to warrant the preparation of a Federalism assessment pursuant to the provisions of Executive Order 13132.

In accordance with Executive Order 12988 (February 7, 1996, 61 FR 4729), the Office of the Solicitor has determined that this rule would not unduly burden the judicial system and would meet the requirements of sections (3)(a) and (3)(b)(2) of the Order.

This rule does not contain any new collection of information that require approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ). OMB has previously approved the information collection requirements associated with permitting and reporting requirements associated with native endangered and threatened species, and experimental populations, and assigned the following OMB Control Numbers:

• 1018-0094, “Federal Fish and Wildlife Permit Applications and Reports—Native Endangered and Threatened Species; 50 CFR 10, 13, and 17” (expires 03/31/2021), and

• 1018-0095, “Endangered and Threatened Wildlife, Experimental Populations, 50 CFR 17.84” (expires 12/31/2020).

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.

In compliance with all provisions of the National Environmental Policy Act of 1969 (NEPA), we have analyzed the impact of this proposed rule. Based on this analysis and any new information resulting from public comment on the proposed action, we will determine if there are any significant impacts or effects caused by this rule. In cooperation with the NPS and the Yurok Tribe, we have prepared an environmental assessment on this proposed action and have made it available for public inspection: (1) In person at Redwood National and State Parks, Newton B. Drury Center, 1111 2nd Street, Crescent City, CA 95531; and (2) online at http://www.regulations.gov or https://parkplanning.nps.gov/condor. All appropriate NEPA documents will be finalized before this rule is finalized.

In accordance with the President's memorandum of April 29, 1994, “Government-to-Government Relations with Native American Tribal Governments” (59 FR 229511), Executive Orer 13175, and the Department of the Interior Manual Chapter 512 DM 2, we have coordinated closely with the Tribal governments near the proposed release site throughout the development of this rule. In collaboration with the NPS, we have extended an invitation for government-to-government consultation to all federally recognized Tribes in the proposed NEP area, have formally met with tribes that have requested government-to-government consultation, stand ready to meet with other tribes that request government-to-government consultation, and will fully consider information and comments received through the consultation process. We will also consider all comments received from Tribes and tribal members during the public comment period.

Executive Order 13211 requires agencies to prepare Statements of Energy Effects when undertaking certain actions. This rule is not expected to significantly affect energy supplies, distribution, and use. Therefore, this action is not a significant energy action and no Statement of Energy Effects is required.

We are required by Executive Orders 12866 and 12988 and by the Presidential Memorandum of June 1, 1998, to write all rules in plain language. This means that each rule we publish must:

(a) Be logically organized;

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

(c) Use clear language rather than jargon;

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

(e) Use lists and tables wherever possible.

If you feel that we have not met these requirements, send us comments by one of the methods listed in ADDRESSESS . To better help us revise the rule, your comments should be as specific as possible. For example, you should tell us the numbers of the sections or paragraphs that are unclearly written, which sections or sentences are too long, the sections where you feel lists or tables would be useful, etc.

A complete list of all references cited in this proposed rule is available upon request from the Pacific Region Office (see FOR FURTHER INFORMATION CONTACT ) or online at http://www.regulations.gov in Docket No. FWS-R1-ES-2018-0033.

The primary author of this proposed rule is Jesse D'Elia of the Pacific Regional Office (see FOR FURTHER INFORMATION CONTACT ).

Accordingly, we propose to amend part 17, subchapter B of chapter I, title 50 of the Code of Federal Regulations, as set forth below:

On March 19, 2019, we, the U.S. Fish and Wildlife Service (Service), published a proposed rule under section 101(a)(5)(A) of the Marine Mammal Protection Act of 1972 (16 U.S.C. 1361(a)(5)(A)) (MMPA), which gives the Secretary of the Interior (Secretary) the authority to allow the incidental, but not intentional, taking of small numbers of marine mammals in response to requests by U.S. citizens engaged in a specified activity in a specified region. The Secretary has delegated authority for implementation of the MMPA to the Service.

On May 3, 2018, Hilcorp Alaska, LLC (Hilcorp), Harvest Alaska, LLC, and the Alaska Gasline Development Corporation, hereinafter referred to as the “applicant,” petitioned the Service to promulgate regulations pursuant to section 101(a)(5)(A) of the MMPA for the nonlethal, unintentional taking of small numbers of northern sea otters ( Enhydra lutris kenyoni ) incidental to oil and gas exploration, development, production, and transportation activities in Cook Inlet, Alaska, for a period of 5 years. On June 28, 2018, the applicant submitted an amended request providing additional project details.

As described in the proposed rule of March 19, 2019 (84 FR 10224), the proposed incidental take regulations (ITR), if finalized, will not authorize the proposed activities. Rather, they will authorize the nonlethal incidental, unintentional take of small numbers of sea otters associated with those activities based on standards set forth in the MMPA. The proposed ITR includes: Permissible amounts and methods of nonlethal taking; measures to ensure the least practicable adverse impact on sea otters and their habitat; measures to avoid and reduce impacts to subsistence uses; and requirements for monitoring and reporting. For further information, please see the proposed rule.

In comments received thus far on the proposed rule, the Service received requests from the Marine Mammal Commission, the Center for Biological Diversity, and the Cook Inlet Keepers to extend the comment period deadline. Accordingly, we will now accept comments until the date specified above in DATES .

If you wish to comment on the proposed regulations, the associated draft environmental assessment, or the information collection, you may submit your comments by any of the methods described in ADDRESSES . Please identify if you are commenting on the proposed regulations, draft environmental assessment, or the information collection, make your comments as specific as possible, confine them to issues pertinent to the proposed regulations, and explain the reason for any changes you recommend. Where possible, your comments should reference the specific section or paragraph that you are addressing. The Service will consider all comments that are received by the close of the comment period (see DATES ).

Comments, including names and street addresses of respondents, will become part of the administrative record. Before including your address, telephone number, email address, or other personal identifying information in your comment, be advised that your entire comment, including your personal identifying information, may be made publicly available at any time. While you can ask us in your comments to withhold from public review your personal identifying information, we cannot guarantee that we will be able to do so.

The following table of contents is intended as an aid to readers:

On February 14, 2005, the Makah Indian Tribe, consistent with its treaty right to hunt whales as defined in the 1855 Treaty of Neah Bay and with the International Convention for the Regulation of Whaling (ICRW), submitted a request seeking authorization under the MMPA for a whale hunt. The Tribe requested a waiver of the MMPA take moratorium to authorize a tribal hunt for ENP gray whales in the coastal portion of the Tribe's U&A in northwest Washington State for ceremonial and subsistence purposes and to allow the making and sale of handicrafts.

The Tribe submitted its 2005 request to the Assistant Administrator of NMFS, who delegated to the Northwest Region (now the West Coast Region) of NMFS authority to complete an analysis under the National Environmental Policy Act (NEPA) and make the initial waiver determination under the MMPA (NMFS, 2005; Makah Tribe, 2006). On May 9, 2008, we, the West Coast Region of NMFS, released a DEIS. We later terminated that DEIS because of new scientific information, published a notice of intent to prepare a new DEIS, and opened a scoping process (77 FR 29967, May 21, 2012). On March 13, 2015, we released a new DEIS (80 FR 13373). The Tribe's request is included as an attachment to the DEIS. After full consideration of the detailed information found in the 2015 DEIS (NMFS, 2015), public comments on our NEPA analysis, consultation with the Marine Mammal Commission (MMC), and information obtained during our review of the Tribe's request, we are proposing to issue a waiver and regulations that would authorize a limited Tribal hunt for ENP gray whales over a 10-year period. The proposed waiver and regulations also reflect our consultation with the Makah Tribe pursuant to Executive Order 13175 (see Section VI).

The primary objective of marine resource management under the MMPA is to maintain the health and stability of the marine ecosystem (16 U.S.C. 1361). The MMPA states that species and population stocks of marine mammals should not be permitted to diminish beyond the point at which they cease to be a significant functioning element of the ecosystem, and they should not be permitted to diminish below their optimum sustainable population (OSP). The MMPA defines the term “population stock” or “stock” as a group of marine mammals of the same species or smaller taxa in a common spatial arrangement, that interbreed when mature (16 U.S.C. 1362(11)). OSP is defined in the MMPA and NMFS regulations as a population size that is within a range from the carrying capacity of the ecosystem (abbreviated as K) down to the number of animals that results in the maximum productivity of the population or the species.

The MMPA requires NMFS (or the U.S. Fish and Wildlife Service) to prepare a stock assessment report (SAR) for each marine mammal stock occurring in waters under U.S. jurisdiction (16 U.S.C. 1386(a)). The SAR must, among other things, describe the stock's geographic range, estimate its minimum abundance (Nmin) and productivity, estimate human-caused mortality, and estimate the potential biological removal (PBR) for the stock. In most cases, Nmin is the lower 20th percentile of the distribution of the most recent abundance estimate and is the value selected by Wade (1998) in developing the PBR methodology. The MMPA defines PBR as the maximum number of animals, not including natural mortalities, that may be removed from a marine mammal stock while allowing that stock to reach or maintain its OSP and includes a formula for calculating PBR (16 U.S.C. 1362(20)).

The MMPA establishes a moratorium on the taking and importing of marine mammals (16 U.S.C. 1371(a)). “Take” means to harass, hunt, capture, or kill, or attempt to harass, hunt, capture, or kill any marine mammal (16 U.S.C. 1362(13)). The moratorium is not absolute. One exception allows NMFS to waive the take moratorium from time to time (16 U.S.C. 1371(a)(3)(A)), adopt suitable regulations governing that take (16 U.S.C. 1373), and issue permits authorizing the take (16 U.S.C. 1374), if certain criteria are met. The Makah Tribe has requested that NMFS waive the take moratorium and issue regulations allowing a tribal hunt for ENP gray whales and the making and sale of handicrafts. If a waiver is granted and regulations are promulgated, then the Tribe must separately seek an MMPA permit to implement a hunt (16 U.S.C. 1374).

A decision to waive the MMPA take moratorium must: Be based on the best scientific evidence available; be made in consultation with the MMC; and have due regard to the distribution, abundance, breeding habits, and times and lines of migratory movements of the marine mammal stock subject to take. Also, in order to waive the moratorium, NMFS must be assured that the taking is in accord with sound principles of resource protection and conservation as provided in the purposes and policies of the MMPA (which include maintaining marine mammals as a significant functioning element in the ecosystem of which they are a part, maintaining the health and stability of the marine ecosystem, and obtaining an optimum sustainable population keeping in mind the carrying capacity of the habitat) (16 U.S.C. 1371(a)(3)(A)).

A decision to waive the take moratorium must be accompanied by regulations governing the take. Regulations to implement a waiver must ensure that the taking will not be to the disadvantage of the stock and will be consistent with the purposes and policies of the MMPA (16 U.S.C. 1373(a)). NMFS has interpreted “disadvantage” in relation to the impact of take on the stock's OSP ( e.g., 45 FR 72178, 72185, October 31, 1980).

In prescribing regulations, NMFS must give full consideration to all factors that may affect the extent to which the stock may be taken, including but not limited to: Existing and future levels of marine mammal species and population stocks; existing international treaty and agreement obligations of the United States; the marine ecosystem and related environmental considerations; the conservation, development, and utilization of fishery resources (in this case, fishery resources will not be affected); and the economic and technological feasibility of implementation (16 U.S.C. 1373(b)). The regulations may restrict, among other things, the number, age, size, and sex of animals taken and the season, manner, and location of the taking (16 U.S.C. 1373(c)). Regulations are subject to periodic review and modification to carry out the purposes of the MMPA (16 U.S.C. 1373(e)).

The MMPA (16 U.S.C. 1373(d)) provides that an agency decision to waive the take moratorium and issue regulations governing the take of marine mammals must be made on the record after an opportunity for an agency hearing. Agency regulations govern the conduct of the agency hearing, call for the appointment of a presiding officer, and prescribe other procedures (50 CFR part 228). Either before or concurrent with the public notice of our intention to issue regulations, we must make available to the public:

1. A statement of the estimated existing levels of the species and population stocks of the marine mammal concerned;

2. A statement of the expected impact of the proposed regulations on the OSP of such species or population stock;

3. A statement describing the evidence before the agency that forms the basis for the regulations; and

4. Any studies made by or for the agency or any recommendations made by or for the agency or the MMC that relate to the establishment of the regulations.

If NMFS waives the MMPA take moratorium for ENP gray whales and issues regulations governing a tribal hunt, the Makah Tribe would have to obtain a permit from NMFS prior to taking any whales. The permit process includes the opportunity for public notice and comment (16 U.S.C. 1374). Under the MMPA, the permit applicant must demonstrate that the taking of marine mammals under the permit would be consistent with the purposes and policies of the MMPA and the applicable regulations. A permit must specify the following:

1. The number and kinds of animals authorized to be taken;

2. The location and manner (which the Secretary must determine to be humane) in which they may be taken;

3. The period during which the permit is valid; and

4. Other terms or conditions that the Secretary deems appropriate.

The MMPA defines “humane” as that method of taking which involves the least possible degree of pain and suffering practicable to the mammal involved (16 U.S.C. 1362(4)). NMFS has worked within the IWC to improve the humaneness of whale-killing methods in aboriginal subsistence whaling, focusing on reducing the length of time to death of a whale ( i.e., reducing the amount of time between the strike and the death) to improve humaneness (IWC, 2004; IWC, 2007; IWC, 2012) as well as to address hunting efficiency. The Makah Tribe proposed to use a toggle point harpoon as the weapon for striking whales and a .50 caliber rifle as the weapon for killing whales. The DEIS describes the detailed analyses commissioned by NMFS and others to examine the suitability of using a .50 caliber rifle to dispatch a gray whale and the conclusions of the reviewers that a .50 caliber rifle is capable of quickly killing a gray whale (DEIS Subsection 3.4.3.5.4, Method of Killing and Time to Death). A determination regarding whether the Tribe's proposed method of hunting is humane and meets the other requirements listed above for issuance of a permit would be decided through the permit process (16 U.S.C. 1374). The permit process is subsequent to and separate from the waiver process and therefore not part of this proceeding. The permit process is described here and discussed elsewhere in this proposed rule to provide context for the proposed regulations. In addition to a NMFS-issued permit, the Tribe would establish a separate process for the issuance of tribal whaling permits by the Makah Tribal Council (Makah Tribe, 2005; Makah Tribe, 2013).

Because the Tribe's request involves a large whale species, the Tribe would need to obtain authorization from NMFS in accordance with the Whaling Convention Act (WCA), which implements the United States' obligations under the ICRW. The ICRW establishes the International Whaling Commission (IWC), an inter-governmental organization whose purpose is the conservation of whales and the management of whaling. The ICRW includes a legally binding document called the “Schedule,” which, among other things, sets out catch limits for aboriginal subsistence whaling.

Since 1997, the Russian Federation and the United States have regularly submitted a joint proposal to the IWC for an aboriginal subsistence whaling catch limit for ENP gray whales on behalf of Chukotkan natives and the Makah Tribe, respectively. In response, the IWC has repeatedly established catch limits for ENP gray whales. At its September 2018 meeting, the IWC approved a new catch limit of 980 ENP gray whales for the period 2019-2025 with an annual cap of 140 whales. This catch limit became effective December 29, 2018 (IWC, 2018a). A bilateral agreement between the United States and Russian Federation sets overall and annual limits for the two countries (Fominykh and Wulff, 2018), with the Makah Tribe entitled to a maximum of 5 whales per year. This agreement also specifies that any quota unused by one country may be transferred to the other. In past years, the United States has transferred its entire quota to Russia for use by the Chukotkan hunters ( e.g., Ilyashenko and Hogarth, 2007; Ilyashenko and DeMaster, 2012; Fominykh and Smith, 2016; Fominykh and Wulff, 2017).

If NMFS waives the MMPA take moratorium for ENP gray whales and issues regulations governing a tribal hunt, the Makah Tribe and NMFS would need to complete procedures established in the WCA and implementing regulations at 50 CFR part 230 to allocate a domestic catch limit for ENP gray whales to the Makah Tribe consistent with the IWC Schedule and the bilateral agreement. This would include publishing those catch limits and entering into a cooperative agreement with the Tribe. Those processes are subsequent to and separate from the MMPA process of waiving the take moratorium and issuing regulations.

The life history, status, and distribution of North Pacific gray whales are described in detail in the DEIS (Subsection 3.4, Gray Whales). We summarize that information here and discuss the ENP gray whale stock in more detail in a companion biological report (NMFS, 2019a), which we incorporate by reference.

NMFS recognizes two stocks of gray whales, one from the western North Pacific (WNP stock) and one from the eastern North Pacific (ENP stock). Through the SAR process, NMFS concluded that the best scientific information available consists of genetic information showing significant mitochondrial and nuclear genetic differences between the WNP and ENP stocks (Carretta et al., 2017). The IWC also manages the two stocks separately (IWC, 2018a), and the International Union for Conservation of Nature recognizes them as two subpopulations (Reilly et al., 2008).

Commercial whaling from the mid-nineteenth through early twentieth centuries dramatically reduced the abundance of the gray whale, leading to its protection by a suite of international agreements and federal laws including the WCA and MMPA. The gray whale was listed as an endangered species under the Endangered Species Act (ESA) and its predecessor statute beginning in 1970 (35 FR 8495, June 2, 1970). As a result of protection from commercial exploitation, the ENP gray whale stock recovered and in 1994 was removed from the ESA's list of endangered and threatened wildlife (59 FR 21094, June 16, 1994). It currently numbers approximately 27,000 animals (Durban et al., 2017). NMFS has continued monitoring the population since its delisting (Carretta et al., 2017). The WNP stock remains listed as endangered (50 CFR 223.102) and numbers approximately 200 non-calf animals (Cooke, 2018).

The ENP gray whale stock spends the winter as far south as the Baja California Peninsula and Gulf of California in northwestern Mexico and migrates north to summer feeding areas as far as the Chukchi and Beaufort Seas. A small group of ENP whales, referred to as the Pacific Coast Feeding Group (PCFG) exhibits seasonal fidelity to feeding grounds off the West Coast of the United States and Canada. Whales that are photo-identified within the region between northern California and northern Vancouver Island (from 41°N lat. to 52°N lat.) during the summer feeding period of June 1 to November 30, in two or more years, are defined by the IWC as belonging to the PCFG (IWC, 2011a; IWC, 2011b; IWC, 2011c). NMFS has adopted this definition (Carretta et al., 2017).

Scientists have studied the PCFG for several decades, and NMFS has monitored the PCFG for more than 15 years. The size of the group has remained relatively stable at about 200 animals since 2002 and is recently increasing (Calambokidis et al., 2017).

NMFS scientists and others have examined genetic and other information to determine whether the PCFG should be considered a separate stock under the MMPA (Frasier et al., 2011; Lang et al., 2011b). They found that sampled whales that meet the definition of the PCFG have small but significant differences in the diversity of mitochondrial DNA (mtDNA), which is inherited only from the mother, compared to whales on the northern feeding grounds of the Bering, Chukchi, and Beaufort Seas. However, no significant differences were found between these two groups when nuclear microsatellite data, which represent the DNA inherited from both parents, were analyzed. Similar results were found by other researchers (D'Intino et al., 2013) despite different sample collections used to represent the PCFG and the larger ENP stock. These results indicate that calves likely follow their mothers to feeding areas and to some extent return to those feeding areas in subsequent years. Whales that frequent one feeding area, however, are not necessarily reproductively isolated from whales that frequent other feeding areas.

NMFS considered whether the PCFG warrants designation as a stock under the MMPA through the SAR process. NMFS has issued several SARs addressing this issue (78 FR 19446, April 1, 2013; 79 FR 49053, August 19, 2014; 80 FR 50599, August 20, 2015). NMFS continues to find that the existing information does not support a conclusion that the PCFG is a stock. This finding is based in part on the deliberations of a NMFS task force that found the evidence equivocal as to whether the population dynamics of the PCFG are more a product of internal recruitment (calves coming to the area with mothers) versus external recruitment (whales recruiting to the area who are not calves of PCFG mothers) (Weller et al. 2013). The current SAR (Carretta et al., 2017) represents NMFS' determination on this issue, although NMFS will continue to evaluate through the SAR process any new science on this issue as it does for the identification of marine mammal stocks in general. Accordingly, this waiver process applies at the level of the ENP gray whale stock as a whole (which includes whales in the PCFG).

In the 2012 SAR, NMFS determined that the ENP gray whale stock was within its OSP range (Carretta et al., 2013). It has remained within OSP since that time. The most recent ENP gray whale SAR notes that abundance will continue to fluctuate in response to human and natural factors affecting carrying capacity, consistent with a population approaching carrying capacity (K) (Carretta et al., 2017). The SAR calculates the PBR for the ENP gray whale stock to be 624 whales per year (Carretta et al., 2017). The primary source of human-caused mortality is the Chukotkan hunt, which took 127 whales per year on average from 2008 to 2012 (Carretta et al., 2017). Other sources of human-caused mortality in U.S. waters, such as ship strikes and entanglement in fishing gear, result in about 6 ENP gray whale deaths per year. The SAR does not calculate a separate PBR for ENP gray whales in U.S. waters, or report on human-caused mortality outside of U.S. waters except for ENP gray whales killed in the Chukotkan hunt. NMFS guidance on preparing stock assessments (NMFS, 2016) advises calculating a PBR for U.S. waters for transboundary stocks when there is no international conservation regime in place and it is reasonable to do so.

Although NMFS does not recognize the PCFG as a separate stock, the 2012 SAR (Carretta et al., 2013) and subsequent SARs have reported on population parameters and calculated an informational PBR for the PCFG, because the PCFG appears to be a feeding aggregation and may warrant consideration as a stock in the future. The term “feeding aggregation” is used by biologists in the scientific literature to describe concentrations of whales that forage in a specific area but the term is not intended to signify that such whales constitute a stock as that term is defined under the MMPA. The SAR notes that calculating this separate PBR allows NMFS to assess whether levels of human-caused mortality are a management concern for this group. (The SAR uses the term “local depletion,” which is not defined in agency regulations or guidelines, so we have not adopted that concept here.) It is unknown whether the PCFG, if it were eventually designated a stock, would be within OSP due to uncertainties in population parameters such as emigration and immigration rates, bycatch mortality, and recruitment (Punt and Moore, 2013).

The most recent (2015) abundance estimate of PCFG whales (Calambokidis et al., 2017) is 243 whales with an Nmin of 228. Calambokidis et al. (2017) note that PCFG abundance estimates show a high rate of increase in the late 1990s and early 2000s and now appear to be relatively stable since 2002. The most recent SAR (Carretta et al., 2017) reports human-caused mortality of PCFG whales in U.S. waters as 0.25 whales per year, based on data from 2008 through 2012. As with most SARs, this is a minimum estimate because not all whales killed as a result of human actions are documented. Similar to the analysis for the entire ENP stock, the SAR does not calculate a separate informational PBR for PCFG whales in U.S. waters, or report on human-caused mortality outside of U.S. waters.

Concerns for ENP gray whales identified in the SAR include injuries due to fisheries interactions, ship strikes, and marine debris, as well as a number of habitat concerns such as industrialization, pollution, and shipping congestion throughout the nearshore migratory corridors. Climate change is likely to affect the availability of habitat and prey species, but species such as the gray whale (which feed on both benthic and pelagic prey) have been predicted in some studies ( e.g., Bluhm and Gradinger, 2008) to adapt better than trophic specialists. Human exploration and development activities ( e.g., for oil and gas deposits) are also expected to increase in the Arctic and elsewhere, which in turn could increase risks to whales from spills, ship strikes, and anthropogenic noise. The SAR does not indicate that these factors are a threat to the OSP status of the ENP stock at this time.

The Tribe has requested a waiver allowing the harvest of 20 ENP gray whales every 5 years and a limit of 7 strikes per hunting season, with the presumption that a struck whale would die. The Tribe proposes hunting only in the coastal portion of their U&A. Its request included provisions to satisfy IWC requirements, avoid local depletion of PCFG whales, safeguard public and hunter safety, and preserve cultural aspects of the hunt while promoting humaneness. The Tribe is also requesting authorization to use non-edible whale products for the making and sale of handicrafts.

Our proposed waiver and regulations respond to the Tribe's request by authorizing a more limited hunt for ENP gray whales for a 10-year period and allowing for the making and sale of handicrafts. Our proposed regulations adopt the Tribe's proposals to limit hunting to the coastal portion of the Tribe's U&A (the hunt area) and to presume that any struck whale will die.

Two key management goals shaped many of the provisions in the proposed regulations: (1) Limiting the likelihood that tribal hunters would strike or otherwise harm a WNP gray whale and (2) ensuring that hunting does not reduce PCFG abundance below recent stable levels. Regarding the first management goal, in adopting regulations to implement a waiver, NMFS must consider all factors that may affect the allowable level of take (16 U.S.C. 1373(b)). Although the Tribe has not requested a waiver of the take moratorium for WNP gray whales, we determined that potential effects of a hunt on WNP whales are a relevant consideration. While uncommon, there are documented occurrences of WNP whales transiting the Makah U&A, and hunters would not be able to visually distinguish WNP whales from ENP whales during a hunt. The regulations are designed to minimize the risk of a WNP whale being struck or harmed over the duration of the waiver.

Regarding the second management goal, the MMPA requires that in waiving the take moratorium we give due regard to, among other things, the distribution and times and lines of migratory movements of the stock subject to waiver, and that the waiver be in accord with the purposes and policies of the MMPA, which include maintaining marine mammals as a functioning element of their ecosystem. PCFG whales exhibit site fidelity during the feeding season to the northern California current ecosystem, a unique area within the range of the ENP gray whale stock. The proposed regulations would limit lethal and sub-lethal effects to PCFG whales to ensure that hunting does not reduce their abundance and distribution within the PCFG range.

Measures in the proposed regulations to achieve these two management goals include:

• Alternating Hunt Seasons. Even-year hunts would occur during the migration season (December 1 of an odd-numbered year through May 31 of the subsequent even-numbered year) to reduce risk to PCFG whales. Odd-year hunts would occur during the feeding season (July 1 through October 30 of odd-numbered years) to reduce risk to WNP whales.

• Strike Limits. 3 strikes during even-year hunts and 2 strikes during odd-year hunts.

• PCFG Strike Limits. 16 strikes over 10 years.

• Landing Limits. 3 whales in even-year hunts and 1 whale in odd-year hunts.

• PCFG Abundance Trigger. Hunting ceases if PCFG abundance falls below 192 whales (or the PCFG minimum abundance estimate falls below 171 whales).

Other management measures in the proposed regulations are described in Subsection III(C) below.

The Tribe originally proposed a hunting season of December 1 through May 31, when most ENP gray whales are migrating to and from northern feeding grounds (the migration season), to minimize the potential that a PCFG whale would be killed. Scientists subsequently observed WNP whales in the ENP, including in the Tribe's U&A, during the migration season (Mate et al., 2015). Although the risk is very small (there are about 200 WNP whales and about 27,000 ENP whales), this creates the possibility that a tribal hunt at that time could strike a WNP whale that is mixed in with ENP whales. To limit the risk of a WNP whale being struck, the proposed regulations would authorize a hunt during the migration season with two important restrictions: (1) Hunting would only be allowed every other year, proposed for even years, and (2) only three whales could be struck in an even-year hunt. The proposed regulations would also authorize a hunt in odd years during the feeding season (July 1 through October 31), when WNP whales would be feeding in the western North Pacific. Because WNP whales are not expected to be in the Tribe's U&A during the feeding season, authorizing a hunt at this time would avoid impacts to WNP whales.

During an even-year hunt, the regulations would allow only one strike in a 24-hour period as a precaution against striking multiple WNP gray whales that might be travelling together in a group (Weller et al., 2012). Also, once a whale were landed, the Tribe could not hunt again until NMFS notified the Tribe whether the landed whale was a WNP whale. In the unlikely event the Tribe did strike a WNP whale (in either an even- or odd-year hunt), all hunting would cease unless and until the Regional Administrator determined that measures were taken to ensure that no additional WNP gray whales were struck during the waiver period. In addition to limits on strikes, the regulations would impose limits on approaches, hunt training activities, and unsuccessful strike attempts, as explained in Subsection III(C) below. Finally, the regulations would not allow hunting in the month preceding and the month following the migration season ( i.e., November and June) to provide extra protection against striking or otherwise harming a WNP whale.

The proposed regulations contain a number of restrictions to limit PCFG mortality, with the goal of maintaining ENP gray whale distribution and functioning within the PCFG feeding area. Consistent with the Tribe's proposal, the regulations would prohibit hunting in the portion of the Tribe's U&A within the Strait of Juan de Fuca, in part as a human safety measure, but also because during the migration season there is a higher proportion of PCFG whales in the Strait. Also, the regulations would allow only 2-strikes during odd-year (summer/fall) hunts, when PCFG whales are most likely to be present in the hunt area. As an additional protection, the regulations would impose a limit of one landed whale in odd-year hunts, creating the potential for a single strike.

The proposed regulations would include a cumulative limit of 16 strikes on PCFG whales over the 10 years of the regulations (for an average of 1.6 whales per year), of which no more than 8 could be females. The strike limit for PCFG females is a precautionary measure given recent evidence that PCFG whales may be recruited through maternally directed site fidelity (Frasier et al., 2011; Lang et al., 2011b). The regulations would also limit approaches, training activities, and unsuccessful strike attempts on PCFG whales, as discussed in Subsection III(C) below, to minimize the risk that the hunt would cause PCFG whales to avoid the PCFG feeding area.

Under the proposed regulations, strikes and unsuccessful strike attempts would be counted against the PCFG strike limits in various ways depending on the season and whether the whale's identity (PCFG or non-PCFG) could be determined through photographic or genetic matching. The regulations propose that any whale struck (landed or struck and lost) during odd-year (summer/fall) hunts would count as a PCFG whale, unless identified as a WNP gray whale. This method of accounting is conservative, as PCFG whales are currently estimated to comprise about 48 percent of gray whales in the hunt area during this time (Calambokidis et al., 2017). During even-year (winter/spring) hunts, a struck whale identified as a PCFG whale would be counted against the PCFG strike limit, while a whale not identified as PCFG would not count against that limit. Struck whales for which identification could not be performed due to lack of a useable photograph or tissue sample would be counted in proportion to the estimated percentage of PCFG whales in the hunt area during the month of the strike, based on the best available information (the current estimate is that about 28 percent of whales in the hunt area during the migration season are PCFG whales (IWC, 2018b)). Females are currently estimated to comprise 50 percent of the PCFG (A. Lang, NMFS, personal communication, 2017), which would be factored into the accounting for struck and lost whales if the animal's sex was unknown.

Finally, in addition to these limits, the proposed regulations would not allow hunting in a given year if the estimated PCFG abundance for that year were below 192 whales or the Nmin were below 171 whales (low abundance triggers). The purpose of this additional measure is to ensure that, in the event PCFG abundance declines, for whatever reason, the hunt would not exacerbate the decline. Given that recent PCFG abundance estimates are around 240 whales with an overall increasing trend and the proposed strike limits would result in PCFG mortality of 1.6 whales per year on average, a reduction on this scale would likely be due to some cause unrelated to the hunt. Because published population estimates typically lag one or more years behind the most currently available survey data, estimates for an upcoming hunting season would be projected using a population forecast model fit to the time series of data. The threshold values of 192 and 171 represent the best and minimum (20th percentile) estimates of abundance for the PCFG in 2007. We selected these levels as the low-abundance triggers because they are the lowest values estimated for the population during the recent period of stability starting in 2002 (Calambokidis et al., 2017).

The Tribe's request, as well as some of the DEIS alternatives, used PBR-based approaches to manage impacts on PCFG whales instead of the combination of PCFG strike limits and low-abundance triggers that we are now proposing. After considering the best available scientific information, including the Tribe's proposal, public and MMC comments on the DEIS, and recommendations from the MMC, we chose the current approach for a number of reasons. First, some public comments and the MMC suggested that a PBR approach should account for total human-caused mortality, including deaths and serious injuries that occur outside U.S. waters. As noted above, the SAR for ENP gray whales (Carretta et al., 2017) calculates an informational PBR overall for the PCFG, not an allocation of PBR for U.S. waters, and reports only human-caused mortality in U.S. waters. Though future SARs might attempt such estimates, we currently lack sufficient information to do so.

Second, the PBR approach establishes a precautionary way (use of PBR achieves the abundance goals in 95 percent of model runs) to manage marine mammal stocks for which relatively little population data exist, such as imprecise and infrequent abundance estimates or little information on trends and productivity, as is often the case for cetaceans and other marine mammals (Taylor et al., 2000; Wade, 1998). For the PCFG, population dynamics are well understood (for example population size and growth are measured accurately and frequently), allowing us to make informed management decisions using other tools. Over 20 years of annual photo-identification surveys have been conducted for the PCFG, yielding relatively precise abundance estimates compared to other cetacean populations. These estimates allow us to employ the population forecast model mentioned above to assist in making more timely decisions for managing PCFG mortality (NMFS, 2019a). This approach is appropriate for the PCFG, where population information is readily available and abundance has been stable over a period of nearly 15 years.

Third, the PBR approach was developed for “closed” populations, where the maximum rate of recruitment is determined in part by the number of births that are biologically possible. In the case of the PCFG, new recruits come from immigration as well as births, and whales leave the population by emigration as well as death. While the informational PBR in the SAR represents a useful tool for the agency to monitor the stability of the PCFG, it may not reflect actual population dynamics because recruitment for an open population is not limited by reproductive biology. Given these considerations, we concluded that reliance on the informational PCFG PBR was not the best available tool for managing the proposed hunt and that the PCFG strike limits and low-abundance triggers would provide a more robust and timely mechanism for achieving our management goal of maintaining PCFG abundance.

In addition to the management goals stated above, the management considerations described below informed our proposed waiver and regulations.

The proposed regulations would allow the Makah Tribe to use edible and nonedible ENP gray whale products with certain restrictions. Tribal members would be able to use, share or gift ( i.e., voluntarily transfer to another person without compensation), and barter ( i.e., noncommercial exchange for items other than money) edible whale products with other members, both within and outside the reservation. Tribal members could also share edible products with non-members within the reservation, but could only share them with non-members outside the reservation as part of a gathering sanctioned by the tribal council where limited quantities were served. This would allow Makah tribal members wide use of edible products within the reservation, including sharing with non-tribal members. Limitations on use outside the reservation are intended to prevent opportunities for commercial exchange. No person would be allowed to sell or purchase edible ENP gray whale products.

For non-edible products, permissible uses would depend on the type and location (on or off the reservation) of the product. The regulations identify three types of non-edible products: Unaltered products (those that have not been fashioned into handicrafts), handicrafts that have been marked and certificated by the Tribe, and handicrafts that have not been marked and certificated. Only handicrafts made by tribal members and marked and certificated by the Tribe could be sold or be possessed off-reservation by non-tribal members. The regulations would allow tribal members to freely exchange unaltered products with one another for personal use or for later fabrication into handicrafts and would allow tribal members to share their handicrafts with non-members without going through the marking and certification process, however possession of non-certificated handicrafts by non-tribal members would be allowed only within the reservation boundaries. To ensure compliance with these provisions, the Tribe would be required to maintain an official record of all articles of Makah Indian handicraft certificated by the Tribe.

Some of the proposed definitions and concepts regarding the use of marine mammal products are similar to those governing the take of marine mammals by Alaska Natives. For example, the definition for barter is consistent with agency regulations at 50 CFR 216.3 pertaining to subsistence use of marine mammals by Alaskan Natives, and the definition for Makah Indian handicrafts is largely based on the agency's definition of authentic native articles of handicrafts in 50 CFR 216.3. Additionally, similar to regulations in 50 CFR 216.23 on Alaska Native exceptions to the marine mammal take moratorium, the proposed regulations provide for different uses of edible and non-edible products, and restrict the location and types of transactions that may occur.

As explained in Section II, if NMFS issues a waiver and regulations allowing a tribal hunt, the Tribe would be required to follow a separate MMPA process to obtain a permit before carrying out a hunt (16 U.S.C. 1374). Prior to issuing any MMPA permit, NMFS must determine, among other things, that the proposed method of taking is “humane,” as defined in the MMPA (16 U.S.C. 1362(4), 1374(b)). To ensure that advances in science and methodology addressing efficiency and humaneness are incorporated in a timely fashion, NMFS would regularly review this issue through the permit process. The proposed regulations provide that NMFS will convene a team of experts to evaluate hunt humaneness and effectiveness after 8 gray whales have been struck, to inform any subsequent hunt permits.

Recognizing that actions by tribal hunters short of killing a gray whale may affect whales and may constitute a take under the MMPA, the proposed regulations would limit the number of approaches and unsuccessful strike attempts, including those associated with hunt training. The regulations define a “hunting approach” as causing a vessel to be within 100 yards of a gray whale during a hunt. The 100-yard limit is consistent with permit conditions NMFS imposes for research vessels on large cetaceans ( e.g., 60 FR 3775, January 19, 1995; 66 FR 29502, May 31, 2001), as well as guidelines for all motorized and non-motorized vessels as defined in NMFS' “Be Whale Wise” guidelines that recommend staying 100 yards (91 m) from all marine mammals, noting that there is a regulation prohibiting approaches closer than 200 yards (183 m) for killer whales in inland waters of Washington (50 CFR 224.103(e)).

The regulations would authorize no more than 353 approaches of ENP gray whales (including both hunting and training approaches) each calendar year, of which no more than 142 could be of PCFG whales. As with strikes, approaches would be accounted for proportionally in even-year (winter/spring) hunts and presumed to all be PCFG whales in odd-year (summer/fall) hunts. These values were analyzed in the DEIS and are maximum estimates based on observations during the Tribe's hunt in 2000 (Gearin and Gosho, 2000). The purpose of this provision is to limit the extent to which WNP and PCFG whales may be encountered and possibly disturbed in the hunt area.

The proposed regulations would authorize no more than 18 unsuccessful strike attempts during even-year hunts and 12 unsuccessful strike attempts during odd-year hunts. These limits are based on experience gained from Makah gray whale hunts conducted in 1999 and 2000 and, as described in the DEIS, rely on a 6:1 ratio of unsuccessful strike attempts to successful strikes. Each training harpoon throw would count as an unsuccessful strike attempt because the level of impact on whales is expected to be similar. Training harpoon throws could occur in any month in even-numbered years but would be restricted to the hunting season (July through October, when WNP whales are not expected in the hunt area) in odd-numbered years to reduce the risk of encountering WNP whales over the waiver period. All training harpoon throws would count against the unsuccessful strike attempt limit in effect during the calendar year of the throw. Similar to the limit on approaches, the purpose of these provisions is to limit the risk of non-lethal impacts, particularly to WNP and PCFG whales.

The proposed regulations recognize training as an important component of the management of a tribal hunt. The proposed regulations define training vessels as those not carrying hunting weapons; training approaches as those made by training vessels; and a training harpoon throw as the use of a blunted spear incapable of penetrating a whale's skin. The proposed regulations would authorize training approaches at any time but would limit the times when training harpoon throws could occur as described above.

Although we expect the Makah tribal government to manage any hunting by tribal members, the proposed regulations anticipate an ongoing oversight role by NMFS through the Regional Administrator for the West Coast Region. The regulations include a number of provisions that facilitate NMFS' oversight. For example, the Tribe must provide NMFS advance notice of hunts; hunt parties must accommodate a NMFS observer on hunt expeditions if requested; and the Tribe must allow NMFS to sample and photograph landed whales. The first hunt permit must be limited to a 3-year term (as opposed to the 5-year maximum under the MMPA) to allow for adjustments in future years if areas for improvement are identified.

The regulations include provisions for photographic (or genetic) identification of WNP and PCFG gray whales. For PCFG whales, we expect most identifications would be performed by the Cascadia Research Collective (Cascadia), which has maintained photo-identification catalogs for many years. Cascadia receives some but not all of its catalog funding for gray whales from NMFS. Several researchers participate in Cascadia's photo-identification program and provide photographs to Cascadia. Photographs taken by researchers under NMFS funding are also provided to the NMFS Marine Mammal Lab in Seattle, Washington. For WNP gray whales, there are currently two catalogs maintained by Russian researchers. The IWC is currently facilitating the development of a unified WNP catalog and related database to be held under the auspices of the IWC (IWC, 2017). Once developed, we expect that Cascadia will have access to this unified catalog and be able to provide identifications of WNP gray whales to NMFS via a contractual agreement.

To ensure that the photo-ID requirements can be effectively implemented, the regulations would require that, before issuing a hunt permit to the Tribe, the Regional Administrator determine that there are adequate photo-identification catalogs and processes available to allow for the identification of PCFG and WNP whales. In addition to the quality of the catalogs, there must be reliable processes in place for making identifications. Currently Cascadia provides this service for the PCFG catalog and has demonstrated an ability to make matches within 24 hours (J. Calambokidis, Cascadia Research Collective, personal communication, 2017). As with the PCFG catalog, Cascadia and curators of the WNP catalogs are able to rapidly compare newly obtained photographs of whales with existing photographs in the WNP catalogs to look for individual matches (J. Calambokidis, Cascadia Research Collective, and Dave Weller, NMFS, personal communication 2019). NMFS will either develop a contractual mechanism or in-house expertise prior to issuing permits to ensure adequate catalogs for PCFG and WNP whales are maintained and matches can be quickly made. Also, we have developed a protocol that describes the requirements for adequate catalogs and for photo and genetic identification processes (NMFS, 2019b).

Under the proposed regulations, any hunt permit issued by the Regional Administrator could require that hunters avoid specified areas to prevent and/or reduce the risk of disturbance to Olympic Coast National Marine Sanctuary resources such as seabirds and pinnipeds. This provision is intended to protect other living resources in the hunt area. Also, if a hunt for ENP gray whales is expected to result in the incidental take of other marine mammals, the regulations require that the Tribe obtain separate MMPA authorizations for such take, as determined necessary by the Regional Administrator, before a hunt permit may be issued.

Relying on the best available scientific evidence and the statutory factors related to gray whale biology and ecosystem considerations, this section presents our determination that the proposed waiver and the proposed regulations are consistent with MMPA requirements.

As discussed above, the MMPA requires that any decision to waive the MMPA take moratorium be based on the best scientific evidence available; be made in consultation with the MMC; and have due regard to the distribution, abundance, breeding habits, and migratory movements of the marine mammal stock subject to take. Also, we must be assured that the taking is in accord with sound principles of resource protection and conservation as provided in the purposes and policies of the MMPA (16 U.S.C. 1361, 1371(a)(3)(A)).

In developing the proposed waiver, we relied on the best available scientific evidence related to the statutory requirements, including the following: the most recent SARs for ENP and WNP gray whales (Carretta et al., 2017); the 2015 DEIS (NMFS, 2015); the NMFS gray whale stock identification workshop (Weller et al., 2013); the NMFS analysis estimating the probability of encountering WNP gray whales during a Makah hunt (Moore and Weller, 2018); IWC modeling of our proposed regulations relative to IWC conservation objectives for North Pacific gray whales (IWC, 2018b); and the NMFS biological report (NMFS, 2019a). We incorporate by reference those documents and the documents cited in those reports.

Subsection V(D) describes the consultation we completed with the MMC.

The biological report (NMFS, 2019a) provides a detailed description of our consideration of the distribution, abundance, breeding habits, and migration of ENP gray whales. Below we summarize our assessment of those criteria.

The proposed waiver is unlikely to have an appreciable effect on the distribution of ENP gray whales through mortality of PCFG whales or disturbance of migrating whales or feeding whales. The proposed waiver and regulations demonstrate due regard for the possibility that hunting could result in changes in distribution by including provisions limiting mortality of PCFG whales and limiting interactions with ENP whales in general and PCFG whales in particular. No more than 25 whales could be struck, and only 16 of the strikes could be PCFG whales (average 1.6/year), with a limit of 8 strikes (average 0.8/year) of PCFG females. Unsuccessful strike attempts would be limited to 18 during even-year hunts and 12 in odd-year hunts, and approaches within 100 yards would be limited to 353 (142 PCFG) per year. In addition, the PCFG low abundance triggers would require that hunting cease if PCFG abundance declined below recent stable levels.

Through hunt-related mortality, the proposed waiver may reduce the abundance of PCFG whales by up to 16 whales over a 10-year period. The proposed waiver demonstrates due regard for this possibility by including provisions to maintain PCFG abundance. We conclude that these measures will ensure that the waiver does not reduce range-wide distribution of the ENP stock, including distribution within the PCFG range, based on the following considerations: (1) Agency modeling indicates that the PCFG is likely to grow in the future with or without a tribal hunt (NMFS 2018a). The proposed regulations include protections in the event the PCFG declines rather than increases; (2) If PCFG abundance continues to be stable, removal by hunting of 16 PCFG whales over 10 years is projected to result in an abundance of around 227 whales, which is well above the lowest abundance level observed during the recent period of stability. That level was 192 whales in 2007, and by 2015 the population had grown 25 percent to 243 animals; (3) From 2002 through 2015, the PCFG grew from 197 to 243 animals, which is a total of 46 whales, or an average annual increase of 3.5 whales over 13 years. At that rate of increase, the PCFG would grow by an additional 35 animals over the 10 years of the proposed waiver. That number is twice the maximum number of PCFG whales that could be killed (16) under the proposed regulations; and (4) If PCFG abundance declines, the low abundance trigger would ensure that no hunting will occur if abundance falls below the levels observed during a recent 14-year stable period, specifically 192 animals or an Nmin of 171 animals. Also, the inclusion of an Nmin trigger provides a safeguard against incomplete or lagging abundance estimates.

Though hunt-related activities might cause ENP gray whales to alter their distribution in the hunt area temporarily, it is unlikely that ENP gray whales will exhibit noticeable redistribution during either the migration or feeding seasons. Even-year hunts and training exercises conducted from December through May would encounter mostly migrating whales that must pass through the ocean portion of the Makah U&A during their lengthy north- and southbound transits. These whales are slow but steady swimmers that often exhibit directed swimming and predictable breathing and dive patterns (Jones and Swartz, 2002). Whales travelling at 3-6 miles per hour (5-10 km per hour; Jones and Swartz, 2002) would be able to transit the widest portion of the Makah U&A (approximately 32 miles or 51 km north-south) in several hours. During migration, gray whales generally remain close to shore (especially where the continental shelf is narrow) and the best available information indicates that most northbound and southbound whales migrate within 27 miles (43 km) of shore (Pike, 1962; Green et al., 1992; Green et al., 1995). Some researchers have suggested that gray whales alter their migration distance from shore in response to vessels and other human activity (Rice, 1965; Hubbs and Hubbs, 1967; Wolfson, 1977; Schulberg et al., 1989; Mate and Urbán-Ramirez, 2003), however the ENP population has also demonstrated a tolerance and resiliency to decades of active hunting by Chukotkan natives (Borodin et al., 2012; IWC, 2016).

During even-year hunts, adverse weather conditions in the Makah U&A in winter and early spring coupled with shorter periods of daylight would keep most hunts and training exercises close to shore and of shorter duration than during the summer. There would be only a few vessels associated with the hunt (generally 5 or less). Chukotkan hunters typically use a similar number of motorized vessels to pursue individual whales (IWC, 2018c). Since the 1950s, Chukotkan hunters have landed, on average, over 100 ENP gray whales per year (Borodin et al., 2012), and an average of 126 whales per year during the past decade (IWC, 2016). During that decade the majority of whales have consistently been killed in the Chukotsky region with no apparent change in the distance offshore that whales are killed (IWC, 2016). Given these considerations, it is reasonable to expect that most of the roughly 27,000 ENP whales would be subject to little or no hunting pressure in the Makah U&A. Those animals subject to hunting and hunt training activities would experience them as temporary and localized nearshore events within the vast area of the Pacific Ocean. We therefore expect that whales traveling through the Makah U&A during the migration season will not change their migration patterns and avoid the area.

Odd-year hunts during July through October would likely encounter whales exhibiting feeding behavior, including milling in small, localized areas close to shore and typically within 3 miles (5 km) of shore (Brueggeman et al., 1992; Darling, 1984; Sumich, 1984; Mallonée, 1991; Dunham and Duffus, 2001; Scordino et al., 2011). Some animals have been seen clustering relatively far offshore (12-16 miles or 19-26 km) but these sightings are considered unusual (Calambokidis et al., 2009). During summer hunts and training exercises most whales would be found in the PCFG range from northern California to northern Vancouver Island, within which the Makah U&A is a relatively small portion (less than 5 percent of the coastline in the PCFG range). Whales are known to focus on specific areas within this range but also move extensively in search of food (Calambokidis et al., 1999; Calambokidis et al., 2004; Calambokidis et al., 2014). Odd-year hunts would result in fewer whales being struck (1 or 2 per year) than in even-year hunts (up to 3 per year). As noted above, despite hundreds of whales being hunted and killed in Chukotkan hunts (many of which are killed during the summer months) there has not been a discernible change in the availability and location of hunted whales (IWC, 2016).

The proposed waiver allows for over 350 approaches of gray whales each year, most of these approaches would likely involve paddle-driven canoes that, compared to the motorized vessels used in Chukotkan hunts, have much less speed and maneuverability to pursue and maintain close contact with approached whales. This is a very small number of approaches compared with what NMFS authorizes for research permits. Activities that employ vessel approaches on large whales are regularly reviewed by NMFS under the MMPA. When issuing permits under the MMPA, NMFS generally limits the number of approaches within defined distances (typically 100 yards or less for large cetaceans) because of the potential for such approaches within those limits to affect or disrupt whale behavior. For example, NMFS Permit #15569 for ENP gray whales (77 FR 35657, June 14, 2012) authorized 5,000 approaches of gray whales over the course of 5 years. While this is a large number of authorized approaches, the NEPA analysis prepared for that permit found that approaches during research have not been shown to result in long-term or permanent adverse effects on individual animals or their behavior regardless of the number of times the activity occurs because the frequency and duration of the activities allows adequate time for animals to recover from any potential adverse effects such that additive or cumulative effects of the action on its own are not expected. That analysis further notes that no measurable effects on population demographics are anticipated because any sub-lethal effects are expected to be short-term, and the proposed action is not expected to result in mortality of any animals. Given these considerations, we expect that animals exposed to approaches and hunt training activities within the Makah U&A would experience the encounter as a temporary and localized nearshore event that would be insufficient to discourage them from a known source of food. As a result, we do not expect the proposed waiver to cause PCFG whales to abandon the Makah U&A or to otherwise affect ENP gray whale distribution.

The proposed waiver and regulations are unlikely to have an appreciable effect on the ENP gray whale stock's abundance. The proposed waiver would result in a maximum of 3 strikes/deaths per even year hunt and 2 strikes/deaths per odd year hunt, or an average of 2.5 deaths per year. Two and a half animals represent 0.009 percent of the population of 27,000 animals. This level of mortality is a small fraction of the annual variability in the stock's abundance (~16,000-27,000 animals since the mid-1990s) and well below the PBR level (624 whales per year) for the ENP gray whale stock (Carretta et al., 2017). This small number of removals would not have an appreciable effect on the stock's abundance, especially given that any portion of the IWC quota for ENP gray whales that is not harvested by the Makah Tribe is likely to be allocated to Chukotkan hunters, based on recent practice and as articulated in a joint U.S.-Russia monitoring agreement ( e.g., Fominykh and Wulff, 2017). If that practice continues, the total harvest of ENP gray whales would be the same with or without the waiver.

Male and female gray whales are thought to be promiscuous breeders and copulate repeatedly with more than one mate (Jones and Swartz, 1984). Mating occurs throughout the southward migration in the migratory corridor with a mean conception date of December 5 (Rice and Wolman, 1971). Females that have not successfully bred may enter a second estrous cycle within 40 days (Rice and Wolman, 1971). Hunting or hunt training is most likely to overlap with gray whale breeding in December-January. As described in the DEIS Subsection 3.15.3.2.2, Description of Weather and Sea Conditions in the Project Area, NMFS expects that few if any hunt activities would occur in December-January due to inclement weather (NMFS, 2015). While it is possible that hunt activities could occur in December-January and could encounter mating whales, we do not expect adverse biological effects due to the small portion of the migration corridor where hunt activities could occur. The limited level of hunt activity likely to occur, and the fact that whales can mate repeatedly throughout the migration, suggests that any whales disturbed by hunt activities would have additional opportunities to breed.

Based on the analysis above regarding effects on distribution of ENP gray whales, the proposed waiver is not expected to affect the times and lines of migratory movements of ENP gray whales.

The purposes and policies of the MMPA include maintaining marine mammal stocks as a significant functioning element in the ecosystem of which they are a part, maintaining the health and stability of the marine ecosystem, and obtaining an optimum sustainable population keeping in mind the carrying capacity of the habitat (16 U.S.C. 1361). Thus we considered the effects of the proposed waiver on both the ecosystem and on the ENP stock and documented those findings in the Biological Report (NMFS, 2019a). We summarize those findings below.

The MMPA does not specify a geographic scale for identifying marine mammal ecosystems. Because of their long migration route, ENP gray whales occupy multiple large marine ecosystems at different times. The hunt area is located within what oceanographers call the California Current System (Sherman and Alexander, 1989) or Province (Longhurst, 1998), a part of the North Pacific Gyre that moves cool ocean waters south along the western coast of North America, beginning off British Columbia, flowing southward past Washington, Oregon and California, and ending off Baja California. Within that province, scientists regularly study and predict physical and biological features and processes in the northern California Current ecosystem, which is generally described as extending from northern California to Vancouver Island ( e.g., Field et al., 2001; Field et al., 2006; Hickey and Banas, 2008; Sydeman and Elliott, 2008; Harvey et al., 2017; Wells et al., 2017), though some studies extend only to the U.S.-Canada border in the north because of differing management regimes between the two countries (Field et al., 2001; Field et al., 2006). For purposes of the MMPA analysis, we took a precautionary approach of examining the impact of the proposed waiver and regulations on the smaller northern California Current ecosystem. This area also corresponds to the seasonal range of the PCFG.

The entire range of the ENP gray whale stock is vast and crosses many large marine ecosystems, including the Pacific Central American Coast, California Current, Gulf of Alaska, and Bering and Chukchi Seas (Longhurst, 1998; Sherman and Alexander, 1989). The proposed waiver could result in the removal of up to 2.5 whales annually, on average, from the hunt area. This level of removal is an order of magnitude less than the natural variability of the population, which numbered nearly 27,000 individuals in 2016, and would not have an appreciable effect on the functioning of ENP gray whales as an element of these large ecosystems, or on the health of the ecosystems themselves. To the extent approaches and attempted strikes affect whales, those actions would do so in a very small portion of one of these large ecosystems and would therefore be unlikely to result in a change in gray whale use of any of these large ecosystems.

Also, the proposed waiver will not result in gray whales ceasing to be a significant functioning element of the smaller northern California Current ecosystem or the environment of the northern Washington coast for at least two reasons. First, these habitats are shaped by dynamic, highly energetic, large-scale processes, and the role of ENP gray whales in structuring these habitats is limited. Second, the proposed waiver and regulations are unlikely to result in an appreciable decrease in the numbers of whales present in the northern California Current ecosystem or the northern Washington coastal environment because of the limits on ENP and PCFG strikes.

Based on the best available evidence as summarized in the Biological Report, we conclude that the proposed waiver and regulations would not cause ENP gray whales to cease to be a significant functioning element in the ecosystem of which they are a part.

• ENP gray whales annually traverse five large marine ecosystems;

• Average annual removal by Makah hunters of up to 2.5 ENP gray whales from a population of approximately 27,000 individuals would not have an appreciable effect on the functioning of ENP gray whales in any of these large marine ecosystems or on the ecosystems themselves;

• The northern California Current ecosystem is the smallest recognized marine ecosystem that encompasses the area of the proposed hunt;

• ENP gray whales play a limited role in structuring the northern California Current ecosystem, which is shaped by dynamic, highly energetic, large-scale ecosystem processes;

• There will continue to be approximately 27,000 ENP gray whales migrating along the coast through the northern California Current ecosystem, thus the functioning of ENP gray whales in that ecosystem will not change;

• Although it is not considered a separate ecosystem, even at the scale of the northern Washington coast (the coastal portion of the Makah U&A) we would not expect the proposed waiver to have any meaningful effects on the marine environment, because ENP gray whales play a limited role in structuring the habitat, which is shaped by dynamic, highly energetic, large-scale ecosystem processes;

• The best available evidence indicates the proposed waiver would not cause gray whales to abandon the hunt area as a summer feeding area or interfere with the PCFG being a significant functioning element of their ecosystem during the summer feeding period in the PCFG range.

The proposed waiver would result in a maximum of 3 strikes/deaths per even year hunt and 2 strikes/deaths per odd year hunt, or an average of 2.5 deaths per year. Two and a half animals represent 0.009 percent of the population of 27,000 animals. This number of removals would not have a discernable effect on the status of the ENP stock relative to OSP. Moreover, any portion of the IWC quota for ENP gray whales that is not harvested by the Makah Tribe is likely to be allocated to Chukotkan hunters, based on recent practice and as articulated in joint U.S-Russia monitoring agreements dating back to the IWC catch limit set in 2003 ( e.g., Ilyashenko and Hogarth, 2007; Ilyashenko and DeMaster, 2012; Fominykh and Smith, 2016; Fominykh and Wulff, 2017). Assuming this practice continues, the proposed waiver would have no net effect on ENP gray whale abundance or OSP.

The MMPA directs NMFS to adopt regulations implementing an MMPA waiver that NMFS deems necessary and appropriate to insure that the taking will not be to the disadvantage of the affected stock and will be consistent with the purposes and policies of the MMPA (16 U.S.C. 1373(a)). Regulations must be based on the best scientific evidence available and consultation with the MMC. NMFS must give full consideration to all relevant factors affecting the extent to which the marine mammals may be taken, including but not limited to: Existing and future levels of marine mammal stocks; international treaty and agreement obligations of the United States; the marine ecosystem and related environmental considerations; the conservation, development, and utilization of fishery resources; and, the economic and technological feasibility of implementation (16 U.S.C. 1373(b)). In addition to these factors, we have considered the potential effects of the proposed regulations on the WNP stock.

See Subsections IV(A)(1) and IV(A)(2) above.

Because the proposed regulations will not affect the status of the ENP gray whale stock relative to its OSP, we conclude that the proposed regulations will not disadvantage the ENP gray whale stock.

These findings are described above in Subsection IV(A)(4) above.

The proposed regulations are unlikely to have any effect on the future levels of ENP gray whales, as described above under Subsection IV(A)(4)(b), Effect of the proposed waiver on the status of the ENP gray whale stock relative to OSP.

The proposed regulations limit the harvest of ENP gray whales consistent with the ICRW Schedule, Article 13, and the U.S.-Russia bilateral agreement. In March 2018 the U.S. requested that the IWC Scientific Committee (specifically the Standing Work Group on Aboriginal Subsistence Whaling Management Procedures or AWMP) evaluate a potential Makah gray whale hunt under the proposed regulations. The goal of the AWMP's review was to determine if the aboriginal harvest of gray whales under hunt proposals by the U.S. and the Russian Federation would meet the IWC's conservation objectives. Those objectives focus on ensuring that aboriginal hunt requests (1) do not seriously increase risks of extinction (highest priority), (2) enable hunts “in perpetuity,” and (3) maintain stocks at the highest net recruitment level (and if below that, ensure they move towards it). After modeling the available data ( i.e., biology, ecology, abundance and trends, removals including direct hunting, ship strikes and bycatches), the AWMP agreed (and the Scientific Committee supported) that the proposed hunt management plan for a Makah tribal hunt meets the IWC conservation objectives for ENP gray whales as well as for PCFG and WNP gray whales (IWC, 2018b).

The biological report (NMFS, 2019a) describes our consideration of effects on the marine ecosystem and Subsection IV(A)(4)(a) describes our conclusion regarding ecosystem function and health. The DEIS (NMFS, 2015) describes our consideration of other elements of the marine environment.

The proposed regulations would have no effect on the conservation, development, or utilization of fishery resources.

Subsection 4.6.2.5 of the DEIS analyzes the economic costs of hunt management and law enforcement. NMFS' costs would primarily involve the continuation of longstanding whale surveys and photo-identification work, with additional funding of approximately $2,000 per day of hunting needed to support NMFS monitoring and enforcement personnel. As noted in the DEIS, the annual NMFS budget for marine mammal management in the West Coast Region is over $700,000, so such costs are feasible to obtain and are not expected to affect NMFS' ability to regulate a hunt. The Tribe's 1999 gray whale hunt successfully demonstrated the economic and technological feasibility of prosecuting a hunt according to the proposed regulations. Also, the Tribe has a detailed Tribal Whaling Ordinance in effect, which demonstrates the Tribe's ability to regulate a tribal ceremonial and subsistence whale hunt (Makah Tribe, 2013). The proposed regulations include provisions for matching photographs of killed whales to those of known whales, a procedure which is technologically feasible (Calambokidis et al., 2017; NMFS, 2019b). The proposed regulations include provisions for marking and tracking handicrafts made from harvest whale parts, which is technologically feasible.

In evaluating the Tribe's waiver request, we determined that the potential effect of the proposed hunt on the WNP stock was an additional relevant factor that should be considered in the proposed regulations. To evaluate the risk to WNP gray whales we considered both: (1) The probability of encountering a WNP gray whale (exposure) during an ENP gray whale hunt or training; and (2) the likelihood that an encounter would kill or otherwise harm a WNP whale. To address the first question and to reduce the risk of encountering WNP gray whales during an ENP hunt, the regulations include several important restrictions: (1) Hunting would only be allowed every other year (proposed for even-numbered years) during the migration season when WNP gray whales may be present; (2) only three whales could be struck in an even-year hunt; (3) training harpoon throws would be restricted to the non-migration season in odd-numbered years; and (4) if a WNP is confirmed to be struck in any year, the hunt will cease until steps are taken to ensure such an event will not recur.

To address the second question, we considered the biological impact of strikes, strike attempts, and approaches on WNP whales. Striking a WNP gray whale has the potential to kill or injure it. An unsuccessful strike attempt, training harpoon throw, or approach of a WNP gray whale might or might not harm a whale by disrupting its behavior, depending on the reaction of the whale to the encounter.

With hunting at the time of year when WNP gray whales may be present limited to every other year and strikes limited to 3 (and thus limited to 15 over the 10-year regulation period), there is about a 6 percent probability of hunters striking one WNP gray whale over the 10 years of the regulations (Moore and Weller, 2018). This probability is the most likely point estimate; the 95 percent confidence interval ranges from 3.0 percent to 9.3 percent. Stated another way, the most likely point estimates indicate that one in 17 10-year hunt periods ( i.e., one year out of 170) would result in an individual WNP gray whale being struck by Makah hunters, if the Tribe made the maximum number of strike attempts allowed in even-year hunts and if ENP and WNP population sizes and migration patterns remained constant (Moore and Weller, 2018). If the 95 percent confidence interval is considered, the expectation is that one WNP whale would be struck out of every 108 years of hunting. By comparison, the PBR for WNP gray whales reported in the current SAR is 0.06 WNP gray whales per year, or approximately 1 whale every 17 years. Based on this analysis, we conclude that the risk of a lethal take or injury to WNP gray whales posed by the proposed regulations is slight.

With unsuccessful strike attempts during even-year hunts limited to 18, there is about a 30 percent probability (95 percent confidence interval, range from 17 percent to 44 percent) that one WNP whale would be subjected to an unsuccessful strike attempt over the 10 years of the regulations (Moore and Weller, 2018), or one such encounter every 33 years if the Tribe made the maximum number of strike attempts allowed in even-year hunts and if ENP and WNP population sizes and migration patterns remained constant (Moore and Weller, 2018). If the 95 percent confidence interval is considered, the expectation is that one WNP whale would be subjected to an unsuccessful strike attempt every 23 years. Making an unsuccessful strike attempt or training harpoon throw on a WNP gray whale is a concern but would not result in death or injury and would likely elicit a response similar to that observed in whales that are tagged or biopsied for research purposes (DEIS Subsection 4.4.3.3.2, Change in Abundance and Viability of the WNP Gray Whale Stock). As summarized above in Subsection III(C)(3), the best available scientific evidence suggests that such encounters would be unlikely to have a lasting effect on the health or behavior of the affected animal because there is no mortality associated with unsuccessful strike attempts and impacts associated with such an event are temporary.

Based on the best available information and as observed during the Chukotkan hunt, gray whales would likely display a range of reactions to hunting- or training-related approaches, and it is uncertain whether any of the approaches would disrupt normal whale behavior. However, to be precautionary we believe it is reasonable to conclude that some of those approaches have the potential to disrupt whale behavior, so the regulations limit the number of approaches. The geographical area where the approaches might occur is not known to be biologically important for WNP gray whales and the very limited number of likely approaches on WNP whales does not create the magnitude, frequency (repetitive, chronic), and duration of encounter that might cumulatively disrupt their behavior (NMFS, 2015). Actual approach distances are not possible to predict. However, as was the case in the Tribe's 1999 and 2000 hunts, even-year hunts would occur during a time when gray whales are migrating, which may further limit close and sustained approaches on gray whales and chronic, repeated, or cumulative exposure to individual whales. Also, some of the approaches could be made during training exercises involving only paddle-driven canoes that have limited ability to pursue and maintain close contact with whales that are actively migrating.

Our risk analysis predicts that approximately 14 WNP gray whales would be approached within 100 yards over the duration of the waiver period (Moore and Weller, 2018). This analysis assumed that all 353 approaches would be made each year, and all of them, including all training approaches, would be made between December 1 and May 31, when WNP gray whales could be present in the hunt area. These conservative assumptions are a useful management tool for understanding the maximum potential impacts to WNP gray whales, but present an unlikely scenario given that hunting in odd-numbered years may also be authorized during the summer and fall when weather and ocean conditions are more suitable for hunting and training. In our 2015 DEIS, we estimated that there would be almost twice as many suitable days for hunting and training during odd-year hunts as during even-year hunts. So, for example, if half of the allowed number of approaches were made during even-year hunts, we would expect that less than one WNP gray whale (0.7) would be approached per year.

Even if all approaches were made between December 1 and May 31, potentially exposing 1.4 WNP gray whales per year to an approach, we consider any risks to such whales to be slight because there is no mortality associated with approaches, some approaches may be so far away as to be undetectable by the whales, and any reactions by approached whales would likely be temporary and not interfere with the whales' active migration.

To summarize, under the proposed regulations, there is a 6 percent probability of killing a gray whale over the 10-year waiver period (put another way, it is likely that one WNP whale would be killed every 170 years), which we consider to be a remote risk. There is a 30 percent probability of an unsuccessful strike attempt on at least one WNP gray whale (or one every 33 years) and a near 100 percent probability of a WNP gray whale being approached (average of 1.4 whales per year), based on conservative assumptions, over the 10-year period of the regulations (Moore and Weller, 2018). We find that this constitutes an acceptable level of risk for management purposes and under the MMPA. In addition, prior to issuing final regulations, NMFS would be required to ensure, pursuant to the consultation requirements of ESA section 7(a)(2), that the hunt would not be likely to jeopardize the WNP stock (16 U.S.C. 1376(a)(2)).

The MMPA requires that, either before or concurrent with publication of our notice of intent to prescribe regulations, we publish certain statements (16 U.S.C. 1373(d)). This section includes those statements.

ENP gray whales are the subject of the proposed waiver and regulations and are recognized as a population stock under the MMPA (Carretta et al., 2017). The most recent population assessment by Durban et al. (2017) estimates the abundance of the ENP gray whale stock at 24,420 to 29,830 whales, with a point estimate of 26,960 and resultant minimum abundance estimate, used for calculating PBR, of 25,849.

The proposed regulations will not have a discernible effect on the ENP gray whale stock relative to its OSP (see Subsection IV(B), The Proposed Regulations are Consistent with the MMPA ).

In proposing the waiver and regulations, we relied on the references cited in the March 2015 Draft Environmental Impact Statement on the Makah Tribe Request to Hunt Gray Whales (NMFS, 2015). We also list relevant references to the scientific literature in a separate biological report (NMFS, 2019a), which identifies other and more recent studies not included in the DEIS. We incorporate by reference the 2015 DEIS and the Biological Report and their associated references. The proposed regulations were also informed by the public comments on the DEIS and our consultation with the MMC.

Relevant studies made by or for NMFS include those on gray whale abundance and stock structure (Punt and Wade, 2012; Weller et al., 2013; Calambokidis et al., 2017), estimation of potential biological removal levels and human caused mortalities (Carretta et al., 2017), forecasting PCFG abundance estimates (NMFS, 2019a), estimating the probability of encountering WNP gray whales (Moore and Weller, 2018) and modeling the proposed regulations relative to IWC conservation objectives for North Pacific gray whales (IWC, 2018b). Also, the DEIS (NMFS, 2015) analyzes the principle components of a Makah gray whale hunt.

Regarding recommendations by the Marine Mammal Commission, the MMC submitted comments on the 2015 DEIS and provided written advice in response to two NMFS requests for consultation in 2017. We first requested consultation with the MMC on May 12, 2017, and shared a preliminary draft of our proposed waiver determination and regulations along with supporting rationale. The MMC replied to our request with a letter dated July 11, 2017, endorsing our plan to issue a waiver determination and recommending several issues for further consideration. After further evaluation and review, and based on comments from the MMC and others on the DEIS related to managing impacts to PCFG whales, we modified our proposal to adopt a non-PBR framework for the PCFG and presented it to the MMC for continued consultation on December 19, 2017. On March 13, 2018, the MMC replied with a second letter expressing support for our modified regulations and encouraging flexibility in hunt management so as to give due regard to the Tribe's identified subsistence and cultural needs. The following summarizes the MMC's advice contained in those consultation letters.

1. The MMC believed that the draft documents lay out a prima facie case that the requirements for granting a waiver under the MMPA have been met and recommended that NMFS proceed with issuing a proposed rule and scheduling an administrative hearing in accordance with the requirements of section 103 of the MMPA and sections 554, 556, and 557 of the Administrative Procedure Act.

2. The MMC noted that its primary concern has been the need to avoid, to the maximum extent practicable, the accidental taking of gray whales from the endangered WNP stock, and secondarily, to avoid taking that could disadvantage the PCFG regardless of whether it is considered a stock. The MMC acknowledged that the design of an odd year/even year hunting pattern is key to both controlling the harvest of PCFG whales and minimizing any take of WNP gray whales.

3. The MMC recommended that NMFS clarify what the implications would be if the PCFG were recognized as a separate stock, especially whether hunting would be allowed to continue under this rule or if new rulemaking would be necessary to consider the status of PCFG whales relative to OSP before the taking of PCFG whales could be authorized.

4. The MMC recommended that the ability to distinguish between WNP and ENP gray whales be addressed in the rulemaking, either by including mechanisms to ensure that current survey and cataloging efforts are maintained or by making hunting during the specified season contingent on having available and reliable means of distinguishing WNP or PCFG whales (as relevant) from other whales.

5. The MMC recommended that NMFS review the proposed numbers of takes that would be authorized for approaches and attempted strikes, and suggested that NMFS consider separate authorizations for attempted strikes and approaches depending on whether they occur during hunting or training exercises. The MMC further noted that it would be unfortunate, and perhaps counterproductive to achieving an effective and efficient hunt, to limit the level of training because of the specified caps.

6. The MMC recommended that NMFS revise the provisions of the draft rule to allow training activities to be conducted throughout the year, subject to appropriate limitations, despite one of the take limits for hunting activities ( e.g., strikes or landings) having been reached.

7. The MMC recommended that NMFS discuss with the Makah Tribe provisions related to how whale meat and non-edible products can be used and distributed by Tribal members to determine whether there are any proposed restrictions on the use and distribution of whale products to which the Tribe objects and, if there are, request that the Tribe suggest alternatives for consideration as part of the rulemaking.

8. The MMC recommended that NMFS consider building some flexibility into the regulations to allow a small increase in the numbers of whales that can be struck and landed in odd-year hunts should it become necessary to close the even-year hunt.

9. The MMC recommended that NMFS address whether there are circumstances ( e.g., a die-off of gray whales) that would prompt it to revisit or revise the regulations before the end of their anticipated lifetime.

1. The MMC reiterated its earlier primary concerns regarding the need to avoid, to the maximum extent practicable, the accidental taking of gray whales from the endangered WNP stock, and secondarily, to avoid taking that could disadvantage PCFG whales regardless of whether they are considered a separate stock. The MMC noted that our modified proposal (compared to our initial request for consultation) is not expected to have any negative effect on the possibility that WNP gray whales will be taken and, as such, the MMC stands by its earlier comment that the risk of killing or seriously injuring a WNP gray whale appears to be sufficiently low that it should not present an insurmountable obstacle to NMFS moving forward with a proposed rule to authorize the Makah Tribe to take whales from the ENP stock.

2. The MMC agreed that, given the availability of reliable information on the abundance, trends, and rates of recruitment for the PCFG, there is no reason to manage removals under a PBR framework. Further, the MMC believed that setting the allowable strike limit at 16 PCFG whales over a 10-year period should provide reasonable certainty that the proposed level of hunting PCFG whales will not have adverse impacts on this group of animals.

3. The MMC noted that proposed harvest levels (no more than one whale landed per year during odd-year hunts and up to three whales landed per year during even-year hunts) falls well short of the Makah Tribe's identified subsistence need and the Tribe's initial waiver request, and encouraged NMFS to assess the relationship between the adopted harvests levels and the Tribe's subsistence and cultural needs as part of the final environmental impact statement on this action.

4. The MMC concurred—from a biological standpoint—with NMFS' proposal to limit strikes on female PCFG whales, but noted that the strike limit may cause additional shortfalls in meeting the Tribe's subsistence needs. Therefore, the MMC recommended that NMFS and other appropriate experts work with the Tribe to develop hunting methods that minimize the chances that the female strike limit will be reached early in any 10-year period.

5. The MMC agreed that setting such minimum abundance thresholds for the PCFG is appropriate and that the values proposed are good starting points for examination in the course of the rulemaking. However, the MMC also noted that this approach was akin to an on-off switch and suggested that NMFS explore whether strikes might be reduced more gradually using intermediate abundance thresholds.

NMFS has prepared a DEIS under the requirements of NEPA and published a notice of availability on March 20, 2015 (80 FR 14912). NMFS believes that a waiver of the MMPA take moratorium along with federally approved hunt regulations for gray whales constitutes a major federal action subject to the requirements of NEPA. Therefore, these proposed regulations will not be finalized until a final Environmental Impact Statement has been issued and a Record of Decision is made.

The ESA provides for the conservation of endangered and threatened species of fish, wildlife, and plants. The program is administered jointly by NMFS (for most marine species) and the U.S. Fish and Wildlife Service (for terrestrial and freshwater species). The ESA requires federal agencies to consult with NMFS or the U.S. Fish and Wildlife Service to ensure that activities authorized, funded, or carried out by federal agencies are not likely to jeopardize the continued existence of a listed species or result in the destruction or adverse modification of designated critical habitat. Prior to issuance of final regulations, NMFS will fulfill its obligations under section 7(a)(2) of the Endangered Species Act for the ESA-listed species and designated critical habitat in the project area.

The Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) (RFA) requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice of proposed rulemaking requirements under the Administrative Procedure Act unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. The RFA defines small entities, in pertinent part, as small businesses, small organizations and small governmental jurisdictions. This rule only affects a single tribe. Tribes are not considered small entities under the RFA. Accordingly, an attorney acting on behalf of the Chief Counsel for Regulation of the Department of Commerce, in accordance with the RFA, has reviewed this proposed rule and certifies that it will not have a significant economic impact on a substantial number of small entities. Therefore, neither the RFA nor any other law require a regulatory flexibility analysis, and none has been prepared.

This proposed rule does not contain a collection-of-information requirement for purposes of the Paperwork Reduction Act of 1980, because the Paperwork Reduction Act does not apply to record-keeping requirements of a single tribe.

Executive Order (E.O.) 12866 provides that significant regulatory actions be submitted for review to the Office of Information and Regulatory Affairs, and OMB. E.O. 13771 provides that it is essential to manage the costs associated with the governmental imposition of private expenditures required to comply with federal regulations. Toward that end, E.O. 13771 directs that for every one new regulation issued, at least two prior regulations be identified for elimination, and that the cost of planned regulations be prudently managed and controlled through a budgeting process. In accordance with 16 U.S.C. 1373(d), the regulations proposed here are subject to 50 CFR 228.3, which provides that this proceeding will be governed by 5 U.S.C. 556 and 557 of the Administrative Procedure Act. Executive Order 12866 per Section 3(d) does not apply to regulations issued in accordance with the formal rulemaking procedures of 5 U.S.C. 556, 557, thus the regulatory action is not considered significant under E.O. 12866. Executive Order 13771 only applies to regulatory actions that are defined as significant under E.O. 12866. Therefore, this proceeding is exempt from review under E.O. 12866 and E.O. 13771.

Executive Order 13563 reaffirms the principles of E.O. 12866 while calling for improvements in the nation's regulatory system to promote predictability, to reduce uncertainty, and to use the best, most innovative, and least burdensome tools for achieving regulatory ends. The E.O. directs agencies to consider regulatory approaches that reduce burdens and maintain flexibility for the public where these approaches are relevant, feasible, and consistent with regulatory objectives. Executive Order 13563 emphasizes that regulations must be based on the best available science and that the rulemaking process must allow for public participation. We have developed this rule in a manner consistent with these requirements.

Under E.O. 12898 each federal agency must conduct its programs, policies, and activities that substantially affect human health or the environment, in a manner that ensures that those programs, policies, and activities do not have the effect of excluding persons from participation in, denying persons the benefits of, or subjecting persons to discrimination because of their race, color, or national origin. Section 4-4, Subsistence Consumption of Fish and Wildlife, of E.O. 12898, requires federal agencies to ensure protection of populations with differential patterns of subsistence consumption of fish and wildlife and to communicate to the public the human health risks of those consumption patterns. NMFS has evaluated the data available on contaminant loads in ENP gray whales, and has summarized this information in the DEIS and in more recent analyses (Ylitalo et al., 2018) and communicated those findings to the Makah Indian tribe.

Executive Order 13132 sets forth principles and criteria that agencies must adhere to in formulating and implementing policies that have federalism implications, that is, regulations that have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Federal agencies must examine the statutory authority supporting any action that would limit the policymaking discretion of the States, and to the extent practicable, must consult with State and local officials before implementing any such action. This rule does not have substantial direct effects on the States and therefore does not have the type of federalism implications contemplated by the Executive Order. We do not foresee that the rule would affect significantly the distribution of power and responsibilities among the various levels of government or limit the policymaking discretion of the States.

Executive Order 13175, the American Indian and Alaska Native Policy of the U.S. Department of Commerce (March 30, 1995), and the Tribal Consultation and Coordination Policy of the U.S. Department of Commerce (May 21, 2013) outline the responsibilities of NMFS in matters affecting tribal interests. These directives require that NMFS have an accountable process to ensure meaningful and timely input by tribal officials in developing policies that have tribal implications. Executive Order 13175 requires that NMFS: (1) Have regular and meaningful consultation and collaboration with Indian tribal governments in the development of federal regulations that significantly or uniquely affect their communities; (2) reduce the imposition of unfunded mandates on Indian tribal governments; and (3) streamline the applications process for and increase the availability of waivers to Indian tribal governments.

We developed these proposed regulations in response to the Makah Indian Tribe's request on February 14, 2005 for a waiver of the MMPA's take moratorium. Consistent with the Executive Order directives we consulted with the Makah Indian Tribe in developing the proposed regulations. The Makah Indian Tribe and members of other tribes submitted comments in response to the DEIS; we will provide responses to those comments at the hearing for this matter.

In keeping with the intent of the Administration and Congress to provide continuing and meaningful dialogue on issues of mutual state and federal interest, NMFS shared the release of the DEIS with 26 state and local government agencies and various elected officials and governmental committees.

A complete list of all references cited in this rulemaking is available on our website and upon request from the NMFS office in Portland, Oregon (see ADDRESSES ).

For the reasons set out in the preamble, 50 CFR part 216 is proposed to be amended as follows: