Federal Register Vol. 80, No.95,

Mechanically tenderizing beef with a needle or blade has the potential to transfer pathogens that may occur on the exterior of the product into its interior. In such circumstances, it is important that the interior of the beef product be fully cooked. Not all mechanically tenderized products are readily distinguishable from non-tenderized products. Recent outbreak data indicate that consumers and food service facilities sometimes do not cook mechanically tenderized raw beef products to a temperature and for a time sufficient to destroy harmful bacteria that may have been transferred to the tenderized interior of the product. FSIS has, therefore, determined that labeling to state that the beef product is tenderized, along with validated cooking instructions, are necessary to provide consumers and food service workers the essential information to safely prepare the product.

On June 10, 2013, FSIS proposed new labeling requirements for raw or partially cooked needle- or blade-tenderized beef products, including beef products injected with a marinade or solution (78 FR 34589). Having reviewed and considered all comments received on the proposal, FSIS is finalizing all the proposed regulatory requirements with minor changes.

FSIS is requiring the labels of raw or partially cooked needle- or blade-tenderized beef products, including beef products injected with marinade or solution, to bear a descriptive designation that clearly indicates that the product has been mechanically tenderized, unless such product is destined to be fully cooked or to receive another full lethality treatment 1 that renders the product ready-to-eat, as defined in 9 CFR 430.1, in an official establishment.2 To provide flexibility and respond to comments, FSIS is requiring in the final rule that the terms “needle tenderized” or “mechanically tenderized” be used as the descriptive designation for needle tenderized beef products and the terms “mechanically tenderized” or “blade tenderized” be used as the descriptive designation for blade tenderized beef products.

In addition, to ensure that the descriptive designation is readily apparent on the label, FSIS is requiring the print for all words in the descriptive designation must appear in a single easy-to-read type style and color and on a single-color contrasting background. The print may appear in upper and lower case letters, with the lower case letters not smaller than 1/3 the size of the largest letter.

FSIS also is requiring that labels of raw and partially cooked needle- and blade-tenderized beef products destined for household consumers, hotels, restaurants, and similar institutions include cooking instructions that have been validated to ensure that any pathogens that may be on or in the product are destroyed. To clarify requirements and respond to comments, FSIS is providing in the final rule that these validated cooking instructions may appear anywhere on the product label.

FSIS proposed to use the January 1, 2016, uniform compliance date as the effective date of this final rule (79 FR 34597). However, according to the uniform compliance date final rule,3 if any food labeling regulation involves special circumstances that justify a compliance date other than the uniform compliance date, FSIS will determine an appropriate compliance date and will publish that compliance date in the rulemaking (79 FR 71008). Because of the potential public health benefits of this rule, the effective date of this rule will be May 17, 2016. Had the final rule published on December 31, 2014, the effective date would have been January 1, 2016, according to the uniform compliance date for food labeling regulations final rule. By establishing a compliance date of May 17, 2016 FSIS is providing establishments with the same 365-day compliance period that they would have had if the final rule had published on December 31, 2014. Therefore, this rule will not be subject to the 2018 uniform compliance date for new meat and poultry product labeling regulations. In addition, FSIS will delay enforcing the labeling requirements for beef products with added solutions 4 until the effective date of this final rule.

Finally, after consideration of the difference between branded (sold in multiple stores) and private labels (sold in only stores with the label name), FSIS reevaluated the label design costs to industry. Based on this analysis, FSIS increased estimated costs associated with the final rule. Even so, FSIS predicts the final rule to have a positive net benefit. In Table 1 (below), FSIS estimates the quantifiable benefits, costs, and net benefits of the final rule.

As explained in the proposed rule, consumers consider product tenderness to be a key factor when purchasing meat products. Thus, the tenderness of a roast or steak is a key selling point for the meat industry (78 FR at 34591). Mechanically tenderized product is product that has been pierced with a set of needles or blades, which breaks up muscle fiber and tough connective tissue, resulting in increased tenderness. As was also explained in the proposed rule, such product may also be injected with a solution or marinade.

In 2009, the Safe Food Coalition sent a petition to the Secretary of Agriculture to request, among other issues, regulatory action to require that the labels of mechanically tenderized beef products disclose the fact that the products have been mechanically tenderized. The petition stated that, (1) consumers and restaurants do not have sufficient information to ensure that these products are cooked safely because FSIS does not provide recommended cooking temperatures for mechanically tenderized products, (2) the recommended cooking temperatures for intact products are not appropriate for non-intact, mechanically tenderized products, and (3) a labeling requirement for mechanically tenderized products is critical for consumers and retail outlets, so that they have the information necessary to safely prepare these products.

In June 2010, the Conference for Food Protection (CFP) petitioned 5 FSIS to issue a mandatory labeling provision for mechanically tenderized beef that would require labels to specify that a cut has been mechanically tenderized. The petition stated that mechanically tenderized beef, especially when frozen, could be mistakenly perceived by consumers to be a whole, intact muscle cut. The petition asserted that without clear labeling, food retailers and consumers do not have the information necessary to prepare these products safely. According to the petition, if labeling does not indicate that the product is mechanically tenderized, consumers are not aware of the potential risk created when these products are less than fully cooked. The petition stated that mandatory labeling of these products would reduce the number of foodborne illnesses in the United States. In April 2014, CFP expressed their support of FSIS moving forward with final rulemaking at a meeting for the Conference of Food Protection.

Published research suggests that pathogens can be translocated from the surface of mechanically tenderized beef products to the interior of the products during processing because of the piercing of the beef by the needle or blade.6 The potential for this translocation of pathogens suggests that the interior of mechanically tenderized beef would have to be more fully cooked than a piece of intact beef with a similar amount of pathogens on the surface.7 Mechanically tenderized meat products are widely available to consumers in the marketplace (78 FR at 34591).

Since 2000, the Centers for Disease Control and Prevention (CDC) has received reports of six outbreaks determined to be attributable to needle- or blade-tenderized beef products prepared in restaurants and consumers' homes. These outbreaks included a total of 176 Escherichia coli (E. coli) O157:H7 cases that resulted in 32 hospitalizations and 4 cases of hemolytic uremic syndrome (HUS).8

In addition, in 2012, 18 cases of food-borne illness caused by E. coli O157:H7 were reported as part of a Canadian outbreak. During the food safety investigation associated with the outbreak, it was determined that a few cases were likely associated with the consumption of mechanically tenderized beef which had been tenderized at the retail level.9 On May 21, 2014, the Canadian Food Inspection Agency announced that it was amending its regulations to mandate Canadian establishments that produce mechanically tenderized beef to label those products as “mechanically tenderized” and provide cooking instructions. The Canadian regulations were effective on August 21, 2014, and are consistent with this final rule.

The Federal Meat Inspection Act (FMIA) gives FSIS broad authority to promulgate rules and regulations necessary to carry out its provisions (21 U.S.C. 621). To prevent meat or meat food products from being misbranded, the meat inspection regulations require that the labels of meat products contain specific information and that such information be displayed as prescribed in the regulations (9 CFR part 317). Under the regulations, the principal display panel on the label of a meat product must include, among other information, the name of the product.

In proposed 9 CFR 317.2(e)(i), FSIS proposed new requirements for raw or partially cooked needle- or blade-tenderized beef products, including beef products injected with a marinade or solution. FSIS proposed that the product name for these beef products include the descriptive designation “mechanically tenderized” and an accurate description of the beef component.

In proposed 9 CFR 317.2(e)(3)(ii), FSIS proposed that the print for all words in the product name be in the same style, color, and size and on a single-color contrasting background.

In proposed 9 CFR 317.2(e)(3)(iii)), FSIS proposed that the labels of raw and partially cooked needle- or blade-tenderized beef products destined for household consumers, hotels, restaurants, or similar institutions include validated cooking instructions. FSIS also proposed that the validated cooking instructions include the cooking method, inform consumers that these products need to be cooked to a specified minimum internal temperature, state whether the product needs to be held for a specified time at that temperature or higher before consumption to ensure destruction of potential pathogens throughout the product, and contain a statement that the internal temperature should be measured by a thermometer.

FSIS explained in the proposed rule that should the rule be implemented, raw or partially cooked beef products subject to this rule whose labels do not include the descriptive designation “mechanically tenderized,” and such products destined for household consumers, hotels, restaurants, or similar institutions whose labels do not include validated cooking instructions, would be misbranded because the product labels would be false or misleading, because the products would be offered for sale under the name of another food, and because the product labels would fail to bear the required handling information necessary to maintain the products' wholesome condition (21 U.S.C. 601(n)(1), 601(n)(2), and 601(n)(12)) (78 FR 34595).

FSIS also announced in the proposal that it had posted on its Web site draft guidance on developing validated cooking instructions for mechanically tenderized product.

FSIS is finalizing the proposed regulations with minor changes to provide additional clarification and flexibility. In response to comments, this final rule requires the descriptive designation “mechanically tenderized” or “needle tenderized” be used on raw or partially cooked needle tenderized beef products and the descriptive designation “mechanically tenderized” or “blade tenderized” be used on raw or partially cooked blade tenderized beef products. By permitting the terms “needle tenderized” and “blade tenderized” to be used as the descriptive designation, FSIS is providing additional flexibility to establishments to use more specific terms regarding the method of mechanical tenderization as part of the product name.

This final rule requires a descriptive designation as part of the product name, not as part of the common or usual name of the product. Thus, for a steak that has been tenderized, the common or usual name would be “steak.” It would not be “mechanically tenderized steak.” However, the descriptive designation needs to be in close proximity to the common or usual name. The descriptive designation may be above, below, or next to the rest of the product name (without intervening text or graphics) on the principal display panel. In response to comments on the proposed rule on mechanically tenderized beef products and on the proposed rule for raw meat and poultry products containing added solutions (76 FR 44855), this final rule provides that the print for all words in the product name and descriptive designation on raw or partially cooked mechanically tenderized products must appear in a single easy-to-read type style and color and on a single-color contrasting background. In addition, the final rule allows additional flexibility by providing that the print may appear in upper and lower case letters, with the lower case letters not smaller than 1/3 the size of the largest. These requirements are consistent with those in the final rule for raw meat and poultry products containing added solutions.10

In response to comments, the final rule also clarifies that validated cooking instructions may appear anywhere on the product label and that a descriptive designation will not be required for mechanically tenderized beef products destined for a full lethality treatment at an official establishment.

FSIS has carefully considered the available information on mechanically tenderized beef and has concluded that, without specific labeling, consumers and industry may be purchasing and preparing raw or partially cooked mechanically tenderized beef products without knowing that these products have been needle- or blade-tenderized. Because illnesses could be reduced if the Agency required more specific labeling, the final rule requires the product name of raw or partially cooked, mechanically tenderized beef products include the name of the beef component and a descriptive designation that the product has been “mechanically tenderized,” “needle tenderized,” or “blade tenderized,” unless the product is destined to be fully cooked or to receive another full lethality treatment in an official establishment. The descriptive designation will provide household consumers, official establishments, restaurants, and retail stores with the information they need to distinguish a cut of beef that is an intact, non-tenderized product, from a non-intact, mechanically tenderized product.

Based on the requirements in 9 CFR 317.2(c)(1), all of this information will need to appear on the principal display panel of the immediate container. FSIS is requiring that the descriptive designation be a part of the product name so that the statement is prominently placed on the label and with such conspicuousness as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use (see 21 U.S.C. 601(n)(6)).

The descriptive designation will only apply to raw or partially cooked beef products that have been needle- tenderized or blade-tenderized, including beef products injected with marinade or solution. Other tenderization methods, such as pounding and cubing, change the appearance of the product, putting consumers on notice that the product is not intact. Moreover, most establishments already label cubed products as such.

FSIS is requiring the terms “mechanically tenderized,” “needle tenderized,” or “blade tenderized” because they accurately and truthfully describe the nature of the product. These terms also clearly differentiate needle- or blade-tenderized beef products from non-tenderized, intact beef products.

As explained in the proposed rule, under current regulations, to prevent raw and partially cooked meat products from being misbranded, the labels of all meat products, including those that have been mechanically tenderized, must bear safe handling instructions as prescribed in 9 CFR 317.2(l). Although the safe handling instructions in the regulations include “cook thoroughly,” the regulations do not require that these instructions specify a dwell time or internal temperature parameters necessary to ensure that the product is fully cooked.

The safe preparation of this product requires that consumers know to handle the mechanically tenderized product differently than product in which there is potential for transfer of any exterior contamination into the interior of the beef product.

Some consumers of beef products consider a product to be thoroughly cooked product even if it has been prepared to a degree of doneness that is not sufficient for safety.11 12 13 Moreover, because mechanically tenderized beef products have the same appearance as intact beef products, household consumers, hotels, restaurants, and similar institutions may incorrectly assume that products that in fact have been mechanically tenderized products can be prepared similarly to intact products (i.e., that it is okay to cook them to be “rare” or “medium-rare”). Thus, in addition to a descriptive designation that identifies that needle- or blade-tenderized beef products have been mechanically tenderized, under this final rule, FSIS is requiring that labels of raw and partially cooked needle- or blade-tenderized beef products destined for household consumers, hotels, restaurants, and similar institutions include cooking instructions that have been validated to support claims that potential pathogens throughout the product would be destroyed.

FSIS is requiring that the validated cooking instructions include, at a minimum: (1) The method of cooking; (2) a validated minimum internal temperature that would destroy pathogens throughout the product; (3) a statement as to whether the product cooked in the manner described also needs to be held for a specified time at the specified temperature or higher before consumption; and (4) instruction that the internal temperature should be measured by use of a thermometer. The cooking instructions included on the label should be practical and easily followed by consumers. In response to comments discussed below, the final rule provides that validated cooking instructions may appear anywhere on the product label.

Consistent with the regulation on Hazard Analysis and Critical Control Point (HACCP) validation (9 CFR 417.4), to validate the cooking instructions, the establishment will be required to obtain scientific or technical support for the judgments made in designing the cooking instructions, and in-plant data to demonstrate that it is, in fact, achieving the critical operational parameters documented in the scientific or technical support. Just as establishments have to validate their HACCP plans' adequacy in controlling food safety hazards identified during the hazard analysis, so too, under this final rule, establishments that produce raw or partially cooked mechanically tenderized beef products will have to validate their recommended cooking instructions. The scientific support would need to demonstrate that the cooking instructions provided can repeatedly achieve the desired minimum internal temperature and time at that temperature and would need to support that the product is fully cooked to destroy pathogens present in the product. The in-plant data would need to demonstrate that the establishment is, in fact, achieving the critical operational parameters documented in the scientific or technical support. For additional information on validation see the Federal Register notice on HACCP Systems Validation (77 FR 27135; May 9, 2012).14

In response to comments, FSIS has revised its guidance for developing validated cooking instructions for mechanically tenderized products. The Agency has posted the revised guidance on its Significant Guidance Documents Web page. This guidance represents current FSIS thinking. Establishments could collect their own scientific data to support the cooking instruction, use a study from an outside source, or use the revised guidance provided by FSIS. An establishment could use the recommended cooking instructions from the revised guidance on its product labels, without having to conduct additional experiments or provide any further scientific support, if the products it is producing are similar to those in the guidance.

If establishments are unable to use the specific examples in the revised guidance (e.g., because the product is a different thickness or is to be cooked using a method different from one previously studied), the revised guidance also contains instructions on how to develop such support.

In the proposal, FSIS requested comment on specific issues: How it defined “mechanically tenderized,” whether the definition should be incorporated into the regulations, whether the term should include products that have been vacuum tumbled or formed, whether the term would be understood by consumers, on how the proposed labeling changes would impact restaurants and other food service operations, and on the cost estimates outlined in the proposal. FSIS received 122 comments in response to these and other issues in the proposed rule. A majority of the comments (approximately 75) were form letters submitted by individuals. The remaining comments were from individuals, consumer advocacy groups, organizations representing the meat industry, meat processors, retail trade associations, and an organization representing food and drug officials.

FSIS did not receive any comments on whether it should require fully cooked needle- or blade-tenderized beef products to have the descriptive designation on their labels, on how food service workers will likely respond to the proposed labeling changes, on the number of cuts per establishment that would require validated cooking instructions, or on estimated costs for developing validated cooking instructions.

FSIS has summarized and responded to the relevant issues raised by commenters below.

Comment: An individual stated that all of the proposed changes are unnecessary because the safe handling instructions required in 9 CFR 317.2(l) clearly state that raw beef products, including those that are tenderized, must be cooked thoroughly before being consumed. As an alternative to the proposed labeling changes, several organizations representing the meat industry suggested that FSIS focus its resources on improving the safe-handling instructions.

Response: FSIS disagrees that the changes are unnecessary. As FSIS stated in the preamble to the proposed rule, the literature suggests that many consumers are aware of the safe handling instruction labels (see 78 FR at 34592). However, the same literature also suggests that only a portion of consumers reported reading these instructions on raw meat product labels and changing their meat preparation methods because of the labels.15 Furthermore, although the required safe-handling instructions include “cook thoroughly” in raw and partially cooked beef products, the regulations do not require that these instructions specify the dwell time or internal temperature parameters required to support that the product is fully cooked. In addition, despite the safe handling instructions to “cook thoroughly,” consumers, restaurants, and retail stores do not always cook these products fully by using a temperature-and-time combination sufficient to destroy harmful bacteria that may be in the product. They may incorrectly assume that it is safe to cook these products “rare” or “medium-rare.” CDC and other governmental investigators reported that failure to fully cook a mechanically tenderized raw or partially cooked beef product was likely a significant contributing factor in several of the outbreaks.16 17 18 In addition, consumer preference for steaks that are not thoroughly cooked 19 along with the time span of the illness reports suggests undercooking was likely a significant contributing factor in the other investigations as opposed to post-cooking cross-contamination in which illnesses would be more likely to occur at the same time. FSIS has, therefore, determined that labeling to indicate that the beef product is mechanically tenderized, along with validated cooking instructions, is necessary to help inform consumers and industry of a key feature of the product and to instruct them that such products need to be thoroughly cooked.

In addition, in January, 2014, FSIS sought input from the National Advisory Committee on Meat and Poultry Inspection 20 to fully explore whether there is a need for enhancing the safe food handling label on meat and poultry packages (78 FR 77643; Dec. 24, 2013). The Committee recommended that FSIS pursue changes to the existing safe handling instructions. FSIS has initiated a project to research how we might modify the current safe-handling instruction requirements to improve consumer food safety behaviors.

Comment: Several comments stated that the proposed labeling changes will be ineffective in influencing consumer behavior to reduce relative risk. Moreover, an organization representing meat and poultry processors and a trade association stated that the Agency failed to provide any data to support that the proposed labeling changes can or will positively impact public health; thus, creating an unnecessary burden on industry.

Response: FSIS recognizes that not all consumers will change their behavior in response to the presence of the descriptive designation “mechanically tenderized,” “needle tenderized,” or “blade tenderized,” and validated cooking instructions on the product label. However, FSIS disagrees that the labeling changes will not positively impact public health. Public health is characterized on a population level. As discussed below, on the basis of available studies on the impacts of food product labels on consumer behavior, FSIS used 24 percent as the primary estimate for the impact of labels on consumer behavior. Therefore, FSIS estimates that 24 percent of consumers that previously cooked mechanically tenderized beef to a lower temperature will change their behavior and cook that product to the endpoint temperature that appears in the cooking instructions, which is equivalent to 210 illnesses averted or prevented per year, with a range of 131 to 489 (See Table 5).

Comment: An organization representing the meat industry and a retail trade association characterized the Agency's proposed use of the term “mechanically tenderized” as overly broad and inaccurate. Both commenters stated that adding solutions by needle injection does not “mechanically tenderize” the product. A trade association requested that vacuum-tumbled products not be considered “mechanically tenderized.”

Consumer organizations requested that “mechanically tenderized” product include vacuum-tumbled, vacuum-marinated, marinade-injected, and enzyme-formed beef products. An individual and a meat processor requested that mechanically tenderized product include products that are vacuum-tumbled because they stated the potential health risk to consumers is similar to that for needle- or blade-tenderized beef products. One consumer advocacy group remarked that, although enzyme-formed beef is now required to be labeled “formed,” the designation does not inform the consumer on how the meat should be prepared or on the higher risk of exposure to pathogens that these products present.

Several meat processors and trade associations stated that use of the descriptive designation “mechanically tenderized” on the label will be misunderstood by consumers as a negative term and, therefore, may discourage customers from purchasing such beef products, resulting in a negative economic impact to small businesses. In addition, several organizations representing the meat industry requested that FSIS conduct targeted consumer research to determine whether the public perceives the descriptive designation “mechanically tenderized” as negative before finalizing the proposed changes.

As alternatives to “mechanically tenderized,” commenters suggested “tenderized and packaged,” “tenderized,” “marinated,” “injection marinated,” “solution enhanced,” “cubed,” and “blade tenderized.”

Response: After review and consideration of the alternative descriptive designations provided by commenters, FSIS is finalizing the proposed regulations with minor changes. FSIS has concluded the descriptive designations “mechanically tenderized,” “needle tenderized,” and “blade tenderized” accurately and truthfully describe the nature of the product. Additionally, these term clearly and completely identify the preparation process that the product underwent, as required by 9 CFR 317.2(e). FSIS has previously described mechanically tenderized beef products in a similar manner, notably in its Federal Register notice, HACCP Plan Reassessment for Mechanically Tenderized Beef Products (May 26, 2005; 70 FR 30331). Moreover, comments and other data do not support that the descriptive designations “mechanically tenderized,” “needle tenderized,” or “blade tenderized” would be misunderstood by consumers, restaurants, retail stores, and official establishments or that the other alternatives would be better understood by these parties. Furthermore, FSIS's definition of “mechanically tenderized” for raw and partially cooked beef products is consistent with that contained in the Canadian Food and Drug Regulations. 21 To provide flexibility, FSIS is requiring the terms “needle tenderized” or “mechanically tenderized” be used as the descriptive designation for needle-tenderized beef products and the terms “mechanically tenderized” or “blade tenderized” be used as the descriptive designation for blade-tenderized beef products. The terms “needle tenderized” and “blade tenderized” merely provide more specific information on the mechanical methods used to tenderize the product. The terms “needle tenderized” and “blade tenderized” are not interchangeable. Only blade-tenderized product will be allowed to bear that descriptive designation, and only needle-tenderized product will be allowed to bear that descriptive designation. “Mechanically tenderized” could be used on either needle- or blade-tenderized product.

Even though vacuum-tumbled or enzyme-formed beef products are processed in a manner that may introduce pathogens (if present) below the product's surface, this final rule will not apply to them. FSIS regulations (9 CFR 317.8(b)(39)) already require labeling for meat products that are formed or re-formed with an enzyme binder as part of the product name, e.g., “Formed Beef Tenderloin.” As such, formed beef products are already labeled in a manner that distinguishes them from other products. In addition, FSIS has concluded that there is not sufficient data to understand whether the risk that pathogens may be introduced into product as a result of vacuum tumbling or enzyme formed beef product is similar to that associated with needle- and blade-tenderized beef.

As stated in the preamble of the proposal, FSIS will conduct a public education campaign to explain the significance of the terms “mechanically tenderized,” “needle tenderized,” and “blade tenderized” to consumers (78 FR at 34593). Thus, FSIS disagrees that additional consumer research is needed before moving forward with a final rule.

Comment: Several consumer advocacy groups requested that the descriptive designation appear on the label in distinguishing typeface. Other consumer advocacy groups suggested that the descriptive designation be added to the package as a brightly-colored sticker, separate from the existing label, placed on the front of the packaging. Several meat processors and organizations representing the meat industry requested that the descriptive designation be permitted to appear on the label in a smaller font size than that of the product name. A trade association opposed the addition of the descriptive designation to the product name because it has found that consumers pay the least attention to tenderization information when it is included in the product's name. Noting that other FSIS labeling requirements to enhance food safety (for example, the safe handling instructions) effectively convey useful information that is not part of the product name, a meat processor and several trade associations requested that, rather than in the product name, the descriptive designation be permitted to appear elsewhere on the label.

Response: To make the descriptive designation readily apparent on the label but provide flexibility and address the comments discussed above, FSIS is requiring that the print for all words in the product name and descriptive designation appear in a single easy-to-read type style and color and on a single-color contrasting background. In addition, the print may appear in upper and lower case letters, with the lower case letters not smaller than 1/3 the size of the largest letter.

Establishments or retail stores will be permitted to add the required information to existing label designs, or they can apply a separate sticker with the required information to existing labels. Regardless, the product name must contain the term “mechanically tenderized,” “needle tenderized,” or “blade tenderized” as an accurate description of the beef component of the product.

The labels of raw and partially cooked mechanically tenderized beef products as required in this final rule will be considered to be generically approved. The labels will not have to be submitted to FSIS for approval prior to their use, provided that they meet the requirements in this rule, display all mandatory features in a prominent manner in compliance with part 317, and are not otherwise false or misleading in any particular manner (9 CFR 412.2).

Comment: A retail trade association requested that FSIS provide options for the descriptive designation for those labels that are under a certain size (e.g., if a label has less than or equal to six (6) square inches of available printing).

Response: FSIS is not aware of any raw or partially cooked mechanically tenderized beef product marketed in a package too small (i.e., with less than six square inches of available labeling space) to accommodate the requirements of this final rule.

Comment: So that restaurant patrons can make informed decisions as to how their beef product should be prepared, several individuals requested that restaurants be required to disclose on their menus when products are made from mechanically tenderized beef. A trade association recommended that FSIS align any proposed labeling requirements for restaurants with the Food and Drug Administration (FDA). A consumer advocacy group urged FSIS, in partnership with retail or restaurant associations, to develop an “information system” targeted at those preparing mechanically tenderized beef products served at restaurants.

Response: FSIS expects that, by requiring the use of the descriptive designation “mechanically tenderized,” “needle tenderized,” or “blade tenderized,” and validated cooking instructions, food service personnel will be able to identify mechanically tenderized beef as such and to safely prepare the product using the cooking instructions provided on the label.

Food service personnel should contact their local or State health department for information on the rules and regulations governing the preparation of food in restaurant, retail, or institutional settings.

FSIS plans to share issues raised in comments received on restaurant menu labeling in response to the proposed rule with FDA.

Comment: An industry trade association stated that FSIS failed to assign a dollar value to many of the purported benefits and costs discussed in the proposed rule.

Response: FSIS made every effort to quantify all known costs and benefits of the proposed rule. However, because of the uncertainty in determining producer and consumer response to the proposed rule, FSIS acknowledges that it was unable to monetize some potential costs and benefits. FSIS did not forecast, nor did it receive data to quantify, in the final rule the loss to producers that sell mechanically tenderized beef products, the loss to consumers when cooking the products to a higher temperature, the loss to consumers who may substitute products that they may like less than mechanically tenderized products because of cooking the mechanically tenderized beef product to a higher temperature, or the loss to food service providers that change their processes.

Comment: Several meat processors and organizations representing the meat industry stated that FSIS underestimated the costs to industry to comply with the proposed labeling requirements.

Response: FSIS based the proposal's mid-point label design modification costs estimate ($310 per label) on the most detailed study available on the costs associated with the labeling of consumer products, the March 2011 FDA report.22 However, after consideration of the differences between branded and private labels, FSIS updated the cost estimates after determining that 60 percent of the private label modifications would be uncoordinated changes. The cost for a minor uncoordinated label is $4,380 per label (with a range of $2,417 and $7,330), an increase from $310 per label in the proposal estimate. Even with the increased estimate, FSIS predicts the final rule to have a positive net benefit (see Table 5).

In addition, the effective date allows establishments time to use existing labels and will, therefore, result in minimal loss of inventory of labels.

Comment: An individual requested that mechanically tenderized beef subjected to High Pressure Processing (HPP) be exempted from the mandatory labeling requirements outlined in the proposal.

Response: Any mechanically tenderized beef product treated at an official establishment with an intervention or process, including HPP, that has been validated to achieve at least a 5-log reduction for Salmonella and Shiga Toxin-producing E. coli (STEC) organisms (including E. coli 0157:H7) would not be subject to the requirements in this final rule because it has received a full lethality treatment.

In response to this comment, FSIS has modified the proposed codified language (9 CFR 317.2(e)(3)(i)) to clarify that a descriptive designation will not be required on mechanically tenderized beef products destined to receive a full lethality treatment at an official establishment.

Comments: According to commenters, consumers may serve the cooked, mechanically tenderized products without the benefit of a stand time, thereby becoming vulnerable to foodborne illness. Therefore, several comments urged FSIS to require cooking instructions with an endpoint temperature of 160 degrees Fahrenheit. Many comments requested that the method of cooking not appear within the cooking instructions, to prevent confusion among consumers. Likewise, rather than requiring the four elements proposed, several organizations representing the meat industry and a retail trade association stated that the validated cooking instructions should be required to include only two elements—an internal temperature at which pathogens can effectively be destroyed and the recommended use of a meat thermometer to verify this temperature.

Response: FSIS disagrees that the inclusion of the method of cooking within the cooking instructions will confuse consumers. Based on the Agency's experience addressing questions from consumers and based on consumer information from outbreak investigations, FSIS has concluded that the most explicit way to inform consumers as to how to prepare a product that is safe for consumption is to include the cooking method by which the endpoint temperature is achieved within the cooking instructions. Consistent with HACCP requirements, FSIS is providing establishments the flexibility to design cooking instructions. However, in response to comments from consumer groups, FSIS revised its compliance guidance to include a recommendation that if establishments use one of the temperature and time combinations from the FSIS Guidance on Safe Cooking of Non-Intact Meat Chops, Roasts, and Steaks 23 with a temperature less than 145 degrees Fahrenheit and a rest time longer than three minutes (for example, 144 degrees Fahrenheit for four minutes, 143 degrees Fahrenheit for five minutes), then they should consider whether it is practical for consumers to achieve the longer rest time.

The first draft of the compliance guideline for validating cooking instructions recommended establishments consider, among other factors, the state of the product at the start of cooking (e.g., frozen vs. refrigerated vs. room temperature), product thickness, type of cut, rotation of product, method of cooking to include a cold spot determination, and number and location of temperature measurement sites during cooking to ensure the cooking instructions consistently achieve the desired endpoint temperature. However, new research demonstrates the importance of turning steaks multiple times during cooking to ensure consumers consistently achieve the desired endpoint temperature throughout the steak.24 Accordingly, FSIS has revised its guidance to recommend that establishments design cooking instructions for steaks to include turning the product at least twice.

Comment: Several commenters indicated that steaks are more commonly merchandised by weight in ounces, rather than by thickness.

Response: FSIS has revised its compliance guidance for validated cooking instructions to recommend that if an establishment packages products by portion size (e.g., 10, 12, or 14 ounces), it should determine the variability in thickness of products packaged at that portion size and conduct the validation study using a product that represents the thickest product. The guidance now states that products from at least three lots should be measured to determine the worst case scenario.

Comment: Several consumer groups requested that FSIS recommend (within the guidance document) that the statement “fully thaw before cooking” appear on product labels. The commenters cited research that showed that frozen or partially thawed patties took longer to cook to the desired internal temperature of 160 degrees Fahrenheit than fully thawed patties.

Response: FSIS agrees that research has found that patties cooked from the frozen state take longer to achieve the target endpoint temperature than those that have been thawed.25 Moreover, research with patties has shown that temperatures tend to be more consistent across patties that are cooked from the thawed rather than the frozen state.26 Thus, FSIS has revised its guidance to include a recommendation that the instructional statement “fully thaw before cooking” appear on the labels of mechanically tenderized beef products.

Comment: An organization representing the meat industry argued that there is not enough space on most mechanically tenderized beef product labels for the level of detail proposed for cooking instructions.

Response: As stated above, FSIS is not aware of any raw or partially cooked mechanically tenderized beef product marketed in a package too small to accommodate the requirements of this final rule, including those for validated cooking instructions. Based on this concern, FSIS has clarified in the final rule that validated cooking instructions may appear anywhere on the product label.

Comment: Several meat processors and organizations representing the meat industry stated that the proposed changes are unnecessary and will not function to promote public health because the risk of illness associated with mechanical tenderization is “very low,” and “generally equivalent” to that associated with intact cuts of beef. To support these claims, several comments referenced the Agency's 2002 risk assessment, preliminary information provided by FSIS concerning its 2010 work, and the 2013 Canadian risk assessment. Many comments requested that FSIS conduct (and make available to the public) a comparative risk assessment for intact and non-intact beef using current data before finalizing the rule.

Response: The proposed and final benefit analysis used the recently published study by the Centers for Disease Control and Prevention that attributed foodborne illnesses by pathogens to general types of foods.27 This study, along with reports of outbreaks attributable to mechanically tenderized products, allowed FSIS to base its estimate predicting 1,965 illnesses from mechanically tenderized products on analysis of recently observed illness data.

The FSIS attribution analysis is based on the latest published estimates of illness from the Centers for Disease Control and Prevention and for this pathogen product pair allows an estimate of the current risk of illness. No updates to this dataset became available between the proposed and final rule, and therefore, no corresponding changes to the attribution analysis were necessary. The details of this analysis are included in this final rule.

Comment: Several meat processors and organizations representing the meat industry stated that additional labeling is unnecessary because present day intervention strategies, like applying interventions directly before tenderization and following best manufacturing practices, have effectively lowered the risk associated with mechanically tenderized beef products since the outbreaks cited in the proposal.

Response: In the 11-year study cited in the proposed rule, outbreaks of E. coli O157:H7 accounted for 4,844 illnesses.28 The Centers for Disease Control and Prevention estimate 63,153 illnesses from E. coli O157:H7 occur annually. Over an 11-year period this amounts to nearly 700,000 illnesses. Reported outbreaks account for less than 1 percent of these. Thus, the absence of outbreaks in the time after the period studied by Painter, et al., which captured outbreaks through 2008, would not be sufficient to conclude that mechanically tenderized beef has ceased to pose a risk. Since 2008, an additional 2009 outbreak has been attributed to blade-tenderized steaks, which resulted in 10 hospitalizations and one death. Additionally, the 2013 Canadian risk assessment, cited by some commenters, reports a Canadian outbreak attributed to mechanically tenderized beef occurring in 2012. Therefore, data continue to support the need for the rule.

Comment: An organization representing the meat industry and a meat processor opposed the Agency's approach of combining mechanically tenderized product not containing added solutions with mechanically tenderized product injected with a marinade or solution, because, in their assessment, mechanically tenderized products injected with a solution pose a clearly different risk profile.

Response: Production of both mechanically tenderized product not containing added solutions and mechanically tenderized product injected with a marinade or solution involve piercing the surface of the product, which allows translocation of bacteria that may reside on the surface into the interior of the product. The 2013 Canadian risk assessment noted above includes both types of products in its analysis but does not distinguish between the two types in its reported results in which it concludes that the risk of illness from mechanically tenderized products is higher than for non-tenderized products. Therefore, FSIS concludes that its approach is consistent with available data.

Comment: Several comments requested that FSIS require similar mandatory labeling for mechanically tenderized pork and poultry products.

Response: FSIS considered the option to amend the labeling regulations to include a new requirement for labeling all mechanically tenderized meat and poultry products. However, FSIS has concluded that there is not sufficient data on the production practices and risks of consuming mechanically tenderized poultry products or mechanically tenderized meat products, other than beef, to proceed with this option. For example, there have been no known outbreaks for mechanically tenderized poultry or non-beef products.

The final new descriptive designation requirement will apply to all raw or partially cooked needle- or blade-tenderized beef products going to retail stores, restaurants, hotels, or similar institutions or to other official establishments for further processing other than cooking. The final requirements for validated cooking instructions will apply to raw or partially cooked mechanically tenderized beef products destined for household consumers, hotels, restaurants, or similar institutions. If a second establishment repackages the product for household consumers, hotels, restaurants or similar institutions, the second establishment will be responsible for applying the validated cooking instructions to the product label. If retail stores repackage the product, they will be required to include the descriptive designation and validated cooking instructions from the official establishment on the retail label.

Under the final rule, establishments or retail stores may add the required information to existing label designs, or they can apply a separate sticker with the required information to existing labels. Under the provisions for generic approval in 9 CFR 412.2(a)(1), the modifications made to the labels for needle- or blade-tenderized beef products from official establishments are generically approved.

To inform consumers that the nature of needle- or blade-tenderized beef is not the same as that of an intact cut of beef, to make them aware that the consequences of the tenderization process may include the intake of bacteria, and to assure consumers that these products can be prepared safely, FSIS plans to conduct consumer education and awareness efforts as part of its implementation strategy. The Agency will develop webinars and PowerPoint presentations for industry to assist establishments and retail facilities in complying with the new labeling requirements. FSIS staff will also be available to answer questions pertaining to the labeling of mechanically tenderized beef products.

When the rule becomes effective, FSIS inspection program personnel will verify that establishments meet the labeling requirements in this rule. FSIS inspection program personnel review labels and compare them to actual product formulations to verify that, when applicable, the processes used in the production of the product are listed accurately on the label; that the label is not misleading; and that the label is otherwise in compliance with all labeling requirements. If the label does not meet the labeling requirements in this rule, the product will be misbranded (under 21 U.S.C. 601(n)(1), 601(n)(2), 601(n)(6) or 601(n)(12)). FSIS will inform the establishment that it needs to make corrections to its label. In limited circumstances, if the label is particularly problematic (e.g., the label presents potential health, safety, or dietary problems for the consumer), FSIS would rescind the label's approval under 9 CFR 500.8.

Note that intact beef products may bear a descriptive designation of “intact,” consistent with 9 CFR 317.2(e). However, such a descriptive designation is not required. If producers want to use such a descriptive designation on labels of intact product to distinguish it from non-intact product, FSIS would allow the designation and would not consider it a special statement requiring label submission to FSIS and FSIS review prior to using the label. Rather, FSIS would generically approve the labels with the statement based on the provisions for generic approval in 9 CFR 412.2(a)(1).

Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This final rule has been designated a “significant regulatory action,” though not economically significant, under section 3(f) of Executive Order 12866. Accordingly, the rule has been reviewed by the Office of Management and Budget.

FSIS updated the Preliminary Regulatory Impact Analysis to take into account recently updated source data and modified timelines for implementation of the final rule. The changes to the costs and benefits sections incorporate the following factors:

The Final Report of the Expert Elicitation on the Market Shares for Raw Meat and Poultry Products Containing Added Solutions and Mechanically Tenderized Raw Meat and Poultry Product, February 2012 (February 2012 Report),29 estimates that there are 555 official establishments that produce blade-, needle-, and both blade- and needle- tenderized beef products.30 In terms of assigned HACCP processing size, the 555 establishments are comprised of 251 very small, 291 small, and 13 large establishments. Total U.S. beef production was 24.3 billion pounds in 2010.31 The February 2012 Report estimates that the proportion of beef products that is mechanically tenderized is about 10.5 percent of total beef products sold, or 2.6 billion pounds. Of these products, an estimated 318 million pounds were brand-name-packaged by the establishment for retail sales; 640 million pounds were private-label-packaged by the establishment for retail sales; 1,594 million pounds were packaged by the establishment for food service, and 479 million pounds were packaged in retail operations.32

Retail establishments would be involved in repackaging products to be sold at retail. FSIS did not estimate the number of retail establishments that would be involved with repackaging raw or partially cooked mechanically tenderized beef products or the number of labels they would require to be in compliance with this rule.33 However, in the Agency's estimation, very few retail facilities are producing mechanically tenderized beef. FSIS requested comments on the number of retailers who would be involved with repackaging raw or partially cooked mechanically tenderized beef products, but received none.

The new descriptive designation requirement will apply to all raw or partially cooked needle- or blade-tenderized beef products going to retail stores, restaurants, hotels, or similar institutions, or other official establishments for further processing, unless such product is destined to be fully cooked or receive another full lethality treatment at an official establishment. The requirements for validated cooking instructions will apply to raw or partially cooked mechanically tenderized products destined for household consumers, hotels, restaurants, or similar institutions. If a second establishment repackages the product for household consumers, hotels, restaurants, or similar institutions, the second establishment will also be responsible for applying the validated cooking instructions to the product label. If retail stores repackage the product, they will have to include the descriptive designation and validated cooking instructions from the official establishment on the retail label.

This final rule requires all official establishments that produce raw or partially cooked mechanically tenderized beef products to modify their product labels to include the term “mechanically tenderized,” “needle tenderized,” or “blade tenderized” as part of the products' descriptive name and to add validated cooking instructions to the labels of all raw or partially cooked needle- or blade-tenderized beef products destined for household consumers, hotels, restaurants, or similar institutions. To incorporate this information, establishments may add the required information to existing label designs with minor changes.

IRI scanner data indicate that there are 4,148 34 raw beef labels in retail, approximately 11.55 percent (or 479) of which are private label, with the remainder (3,669) branded. Although IRI's geographic coverage—which includes the largest urban areas in the U.S. and a few whole states—may yield a reasonable estimate of the universe of branded retail labels, a substantial number of chains that are large enough to have their own private labels but that only serve small or medium-sized cities may be missed. For this reason, the IRI results will be used as a lower bound on the number of retail labels affected by this rule. To estimate an upper bound, we make use of the estimates in FSIS's 2012 expert elicitation (see Table 2, below) to calculate that 46 percent (22%/[16% + 22% + 10%]) of retail labels may be private label. In this case, there are an estimated 3,152 private retail labels and 6,821 (3,669 + 3,152) total retail labels. Next, these estimates must be adjusted upward to account for food service labels (because the IRI scanner data do not capture food service labels); based on the contents of Table 2, about 52 percent of all mechanically tenderized beef products are for food service. From this, FSIS estimates about 52 percent of beef labels are for food service and the remaining 48 percent of labels are for retail, yielding estimates of 8,616 (4,148/48.14%) to 14,169 (6,821/48.14%) raw beef product labels in the marketplace.

Using the 10.5-percent estimate for the share of beef products that are mechanically tenderized but do not contain added solutions,35 and the 8,616 to 14,169 estimated range for number of beef labels (with brand and private allocations as shown in the previous paragraph), the estimated number of labels for mechanically tenderized beef products without added solutions is 905 (800 brand and 104 private) to 1,488 (1,316 branded and 172 private), as shown in Table 3.

There are an additional 15.8 percent (or 1,338 to 2,199) of all beef products that are mechanically tenderized and also contain added solutions. The cost of label changes for these products is included in another FSIS final rule, finalized in December of 2014, which requires label changes for products with added solutions. These costs were overestimated by using a 12 month compliance period, although changes are required in some cases by January 1, 2016, and in other cases by January 1, 2018. For the products required by the added solutions rule to have label changes by January 1, 2016, if such label changes have not already been completed, this rule will delay by a few months the imposition of labeling change costs. For products required by the added solutions rule to have label changes by January 1, 2018, this rule's requirements related to mechanical tenderization would generate non-negligible costs because the shortening of the compliance period (from 36 months as required by the added solutions rule alone to 12 months as required by this rule). However, the added solutions rule's estimates captured the difference in cost from the 12 and 36 month compliance periods by overestimating the cost of labeling changes for these products under a 12 month compliance period.36

Comments Invited

This AD is a final rule that involves requirements affecting flight safety, and we did not provide you with notice and an opportunity to provide your comments prior to it becoming effective. However, we invite you to participate in this rulemaking by submitting written comments, data, or views. We also invite comments relating to the economic, environmental, energy, or federalism impacts that resulted from adopting this AD. The most helpful comments reference a specific portion of the AD, 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 them only one time. We will file in the docket all comments that we receive, as well as a report summarizing each substantive public contact with FAA personnel concerning this rulemaking during the comment period. We will consider all the comments we receive and may conduct additional rulemaking based on those comments.

On February 12, 2015, we issued EAD 2015-04-51, which was prompted by a fatal accident. Preliminary results of the investigation indicated that the accident was caused by a crack in the spindle, which resulted in the main rotor blade separating from the helicopter. The crack was discovered at the last thread of the spindle retention nut threads. While the investigation could not determine when the crack initiated, it was able to determine that the crack existed, undetected, for a significant amount of time before the separation. EAD 2015-04-51 required, before further flight, conducting a magnetic particle inspection (MPI) in any spindle that had 5,000 or more hours time-in-service (TIS) or where the hours TIS of the spindle is not known. If there was a crack in the spindle, EAD 2015-04-51 required replacing it before further flight. EAD 2015-04-51 also required reporting the inspection results to the FAA within 72 hours.

Since we issued EAD 2015-04-51, inspection reports received by the FAA indicate approximately 20% of the spindles reported with TIS data had evidence of cracks. The FAA also received inspection reports of spindles without TIS data which did not have evidence of cracks. The inspection reports include spindles with cracks at less than 5,000 hours TIS. With analysis of available data, we determined the need to expand the applicability to include spindles with 1,500 or more hours TIS.

On April 10, 2015, we issued EAD 2015-08-51, which supersedes EAD 2015-04-51. EAD 2015-08-51 retains all of the requirements of EAD 2014-04-51 except it reduces the TIS of the spindles to be inspected from 5,000 hours to 1,500 hours. EAD 2015-08-51 was sent previously to all known U.S. owners and operators of these helicopters.

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

Enstrom has issued Service Directive Bulletin No. 0119, Revision 1, dated April 1, 2015, for all serial numbered Model F-28A, F-28C, F-28F, 280, 280C, 280F, and 280FX helicopters with a main rotor spindle, part number (P/N) 28-14282-11 and 28-14282-13. Enstrom has also issued Service Directive Bulletin No. T-050, Revision 1, dated April 1, 2015, for Model 480 helicopters, serial numbers 5001 through 5004 and 5006, and with a main rotor spindle, P/N 28-14282-13, except those aircraft modified with tension-torsion straps. Both service directives specify, for any spindle that has been in service more than 3,500 hours, within 5 hours TIS, sending the spindle to Enstrom for an MPI. For any spindle with less than 3,500 hours TIS, the service directives specify sending the spindle to Enstrom for an MPI at or before it reaches 3,500 hours TIS. The service directives also specify repeating the MPI every 300 hours for spindles with over 3,500 hours TIS.

This AD requires conducting an MPI before further flight to determine if a crack exists in any spindle that has 1,500 or more hours TIS or where the hours TIS of the spindle is not known. If there is a crack in the spindle, this AD requires replacing it before further flight. The MPI of the spindle must be conducted by a Level II or Level III inspector qualified in the MPI method in the Aeronautics Sector according to the EN4179 or NAS410 standard or equivalent. This AD also requires reporting certain information to the FAA within 72 hours.

This AD requires that the MPI be conducted by a Level II or Level III inspector or equivalent and that the results of the MPI be reported to the FAA, whereas the service information specifies that the MPI be accomplished by or reported to Enstrom. This AD requires an MPI on spindles with 1,500 or more hours TIS, whereas the service information specifies performing an initial MPI on spindles with 3,500 or more hours TIS. This AD does not require a recurring inspection, whereas the service information specifies to repeat the MPI every 300 hours TIS for spindles with over 3,500 hours TIS. This AD requires the MPI before further flight, whereas the service information specifies that it be accomplished within 5 hours TIS.

We consider this AD to be an interim action. The inspection reports that are required by this AD will enable us to obtain better insight into the root cause and extent of the cracking, and eventually to develop final action to address the unsafe condition. Once final action has been identified, we might consider further rulemaking.

We estimate that this AD affects 323 helicopters of U.S. Registry and that operators may incur the following costs to comply with this AD. Inspecting the spindles will take about 15 work-hours per helicopter and reporting the required inspection information will take about 0.5 work-hour. We estimate an average labor rate of $85 per work-hour, for a total cost of $1,318 per helicopter and $425,714 for the U.S. fleet. Replacing a spindle will cost $8,164 for parts and no additional work-hours.

A federal agency may not conduct or sponsor, and a person is not required to respond to, nor shall a person be subject to penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a current valid OMB control number. The control number for the collection of information required by this AD is 2120-0056. The paperwork cost associated with this AD has been detailed in the Costs of Compliance section of this document and includes time for reviewing instructions, as well as completing and reviewing the collection of information. Therefore, all reporting required by this AD is mandatory. Comments concerning the accuracy of this burden and suggestions for reducing the burden should be directed to the FAA at 800 Independence Ave. SW., Washington, DC 20591. ATTN: Information Collection Clearance Officer, AES-200.

Providing an opportunity for public comments prior to adopting these AD requirements would delay implementing the safety actions needed to correct this known unsafe condition. Therefore, we found and continue to find that the risk to the flying public justifies waiving notice and comment prior to the adoption of this rule because the previously described unsafe condition can adversely affect the controllability of the helicopter and the initial required action must be accomplished before further flight.

Since it was found that immediate corrective action was required, notice and opportunity for prior public comment before issuing this AD were impracticable and contrary to the public interest and good cause existed to make the AD effective immediately by EAD 2015-08-51, issued on April 10, 2015, to all known U.S. owners and operators of these helicopters. These conditions still exist and the AD is hereby published in the Federal Register as an amendment to section 39.13 of the Federal Aviation Regulations (14 CFR 39.13) to make it effective to all persons.

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.

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

For the reasons discussed, I certify that this AD:

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

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

3. Will not affect intrastate aviation in Alaska to the extent that it justifies making a regulatory distinction; 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.

We prepared an economic evaluation of the estimated costs to comply with this AD and placed it in the AD docket.

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

The Coast Guard will enforce the “Mayor's Hike, Bike and Paddle” marine event in 33 CFR 100.801, Table 1, Line 35 from 9:00 a.m. to 12:30 p.m. on May 25, 2015. These regulations can be found in the Code of Federal Regulations, at 33 CFR 100.801.

Under the provisions of 33 CFR 100.801, a vessel may not enter the regulated area, unless it receives permission from the COTP Ohio Valley or a designated representative. Spectator vessels may safely transit outside the regulated area but may not anchor, block, loiter in, or impede the transit of official patrol vessels. The Coast Guard may be assisted by other Federal, State, or local law enforcement agencies in enforcing this regulation.

This document is issued under authority of 5 U.S.C. 552(a), and 33 U.S.C. 1233. In addition to this document in the Federal Register, the Coast Guard will provide the maritime community with extensive advance notification of this enforcement period via the Local Notice to Mariners (LNM) and Broadcast Notice to Mariners (BNM). If the COTP Ohio Valley determines that the regulated area need not be enforced for the full duration stated in the notice, he or she may use a BNM to grant general permission to enter the regulated area.

The Coast Guard will enforce the Special Local Regulation for the annual “REV3 Triathlon” listed in 33 CFR 100.801 Table 1, Sector Ohio Valley, No. 4 on May 17, 2015 from 7:00 a.m. until 9:30 a.m.

Under the provisions of 33 CFR 100.801, entry into the regulated area listed in Table 1, Sector Ohio Valley, No. 4 is prohibited unless authorized by the Captain of the Port or his designated representative. Persons or vessels desiring to enter into or pass through the Special Local Regulation area must request permission from the Captain of the Port or his designated representative. If permission is granted, all persons and vessels shall comply with the instructions of the Captain of the Port or his designated representative.

This notice is issued under authority of 5 U.S.C. 552(a), and 33 U.S.C. 1233. In addition to this notice in the Federal Register, the Coast Guard will provide the maritime community with advance notification of this enforcement period via Local Notice to Mariners and Marine Information Broadcasts.

If the Captain of the Port Ohio Valley or his Patrol Commander determines that the Special Local Regulation need not be enforced for the full duration stated in this notice of enforcement, he or she may use a Broadcast Notice to Mariners to grant permission to enter the regulated area.

This rulemaking establishes eight special local regulations for four regattas, two swim events, one fireworks display and one air show and six safety zones for six fireworks displays. Each event and its corresponding regulatory history is discussed below.

Special Local Regulations:

Aquapalooza (regatta): A special local regulation was established in 2014 for the Aquapalooza event when the Coast Guard issued a temporary rule entitled, “Special Local Regulations and Safety Zones; Marine Events in Captain of the Port Long Island Sound Zone”. This rule was published on August 12, 2014 in the Federal Register (79 FR 46997).

Great Peconic Race (regatta): A special local regulation was established in 2014 for the Great Peconic Race event when the Coast Guard issued a temporary rule entitled, “Special Local Regulation and Safety Zone; Marine Events in Captain of the Port Long Island Sound Zone”. This rule was published on August 29, 2014 in the Federal Register (79 FR 51479).

Kayak for Camp (regatta): Is a recurring marine event with no regulatory history.

Connecticut River Raft Race (regatta): A special local regulation was established in 2014 for the Connecticut River Raft Race event when the Coast Guard issued temporary rule entitles, “Special Local Regulations and Safety Zones; Marine Events in Captain of the Port Long Island Zone”. This rule was published on August 12, 2014 in the Federal Register (79 FR 46997).

Fran Schnarr Open Water Championship (Swim): Is a recurring marine event with regulatory history. This event was previously named Huntington Bay Open Water Championships Swim (78 FR 31402, May 24, 2013) and the event is being held in a different location this year.

Riverhead Rocks Triathlon (swim): A special local regulation was established in 2014 for the Riverhead Rocks Triathlon event when the Coast Guard issued a temporary rule entitled, “Safety Zones; Marine Events in Captain of the Port Long Island Sound Zone”. This rule was published on August 18, 2014 in the Federal Register (79 FR 48685).

Jones Beach State Park (fireworks): Is a reoccurring marine event with regulatory history. This event is in Table 1 to 33 CFR 165.151 (7.19). We will be using a Special Local Regulation this year for this event due to a determination that a safety zone will be insufficient to mitigate the event's extra and unusual hazards.

Jones Beach (Air Show): A special local regulation was established in 2014 for the Jones Beach Air Show event when the Coast Guard issued a final rule entitled, “Special Local Regulation; Jones Beach Air Show; Atlantic Ocean, Sloop Channel Through East Bay, and Zach's Bay; Wantagh, NY”. This rule was published on May 21, 2014 in the Federal Register (79 FR 29088).

Safety Zones:

Village of Saltaire (fireworks): A special local regulation was established in 2014 for the Village of Saltaire event when the Coast Guard issued a temporary rule entitled, “Safety Zones; Marine Events in Captain of the Port Long Island Sound Zone”. This rulemaking was published on August 18, 2014 in the Federal Register (79 FR 48685).

USCG Academy Fireworks Entertainment (fireworks): Is a first time marine event with no regulatory history.

Boys and Girls Club—Beach Ball 2015 (fireworks): Is a first time marine event with no regulatory history.

Marine at American Wharf (fireworks): Is a first time event with no regulatory history.

Cherry Grove Pride Week (fireworks): Is a first time marine event with no regulatory history.

Riverfest (Fireworks): Is a reoccurring marine event with regulatory history. This event is in Table 1 to § 165.151(7.23). This event is in this temporary rule due to deviation from the date and position listed in the § 165.151 regulation.

The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because doing so would be impracticable and unnecessary. The Coast Guard did not receive the information about the events early enough to publish a Notice of Proposed Rulemaking before the scheduled event dates. In addition, publishing an NPRM is unnecessary for this rule because most of these events are familiar to the community as recurring annual community events. Thus, waiting for a comment period to run would inhibit the Coast Guard's ability to fulfill its mission to keep the ports and waterways safe.

Under 5 U.S.C. 553(d)(3), and for the same reasons stated in the preceding paragraph, the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register.

The legal basis for this temporary rule is 33 U.S.C. 1231, 1233; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6 and 160.5; Department of Homeland Security Delegation No. 0170.1, which collectively authorize the Coast Guard to establish regulatory special local regulations and safety zones.

As discussed in the Regulatory History and Information section, four regattas, seven fireworks displays, two swim events, and one air show will take place in the Coast Guard Sector LIS COTP Zone between April 25, 2015 and September 20, 2015. The COTP Long Island Sound has determined that the eight special local regulations and the six safety zones established by this temporary final rule are necessary to provide for the safety of life on navigable waterways during those events.

Aquapalooza is a boating event open to the Public that attracts many people and boats into Zach's Bay near Jones Beach State Park in Wantagh, NY. The event sponsor expects to have 500 participants. As such, a large number of boats will be operating in close proximity to each other and to swimmers in a nearby designated swim area. Many of these vessels will be operating at dangerous speeds given the congested conditions during the event and at the conclusion of the vent when a large number of vessels will be departing Zach's Bay within a relatively short period of time. These conditions are especially hazardous for any vessels attempting to navigate in the southbound direction, against the flow of the main vessel traffic at the conclusion of the event. The Coast Guard determined that a special local regulation that restricts vessel speed and the flow of vessel traffic will improve the safety of waterway users.

Kayak for Camp is a kayak and paddleboard event that starts at Harbor View Beach, Norwalk, CT to Green's Ledge Light, Norwalk, CT and back to Harbor View Beach, Norwalk, CT. There are two courses in this event; the first course is broken into two different races with distances of 2 miles and 8 miles and the second course is 4 miles long. One safety boat will be present behind the race participants for assistance.

Great Peconic Race is a kayak, surf ski and paddleboard event that starts and ends at Wades Beach on Shelter Island. The race course circumnavigates Shelter Island with a total distance of 19 miles. On the south shore, two event safety vessels will be present with a member of the South Ferry Company Inc. staff with a red flag to stop and then wave paddlers on for safe crossing. One safety boat will be present on the north shore to assist paddlers as well.

Riverhead Rocks Triathlon will be held in Riverhead, NY, with the swimming portion in the Peconic River. The swim course will be along the shoreline of the river, with life guards and safety boats present to assist the race participants.

Fran Schnarr Open Water Championship Swim is an open water swim event that will be held in Huntington Harbor, Huntington Bay, NY. The race course will be along the north shore of Huntington Bay, NY.

Jones Beach State Park fireworks display attracts thousands of spectators to Jones Beach State Park as well as a significant number of spectator vessels to the waters around Jones Beach State Park. The operation of numerous spectator vessels in such close proximity to each other presents additional hazards to the maritime public. The COTP Sector Long Island Sound has determined that these hazards pose a danger to the maritime public. This special local regulation will temporarily regulate three areas around the Jones Beach State Park fireworks display, including portions of the Atlantic Ocean, the navigable waters between Meadowbrook State Parkway and the Wantagh State Parkway, and Zach's Bay. The three areas will be defined as “No Entry Area,” “Slow/No Wake Area,” and “No Southbound Traffic Area.”

Jones Beach Air Show attracts thousands of spectators to Jones Beach State Park as well as a significant number of spectator vessels to the waters around Jones Beach State Park. The operation of numerous spectator vessels in such close proximity to each other presents additional hazards to the maritime public beyond those associated with the aerial activities. The COTP Sector Long Island Sound has determined that these hazards pose a danger to the maritime public. This special local regulation will temporary regulate three areas around the Jones Beach Air Show, including portions of the Atlantic Ocean, the navigable waters between Meadowbrook State Parkway and the Wantagh State Parkway, and Zach's Bay. The three areas will be defined as “No Entry Area,” “Slow/No Wake Area,” and “No Southbound Traffic Area.”

The geographic locations of these regulated areas and the specific requirements of this rule are contained in the regulatory text. This regulation prevents vessels from entering, transiting, remaining, or anchoring within the area designated as a “No Entry Area” during the periods of enforcement, unless authorized by the COTP or designated representative. This regulation also partially restricts movement within the “Slow/No Wake Area” and the “No Southbound Traffic Area” unless authorized by the COTP or designated representative.

Connecticut River Raft Race involves many participants operating human-powered and/or sail-powered vessels of their own design and construction along a stretch of the Connecticut River near Middletown, CT. Due to the hazards facing these participants, including the unknown and/or untested seaworthiness of their vessels and potential limitations to vessel navigation and/or maneuverability, the Coast Guard determined that a special local regulation that restricts vessel speed and operation is needed to protect participants, spectators and other waterway users during the event.

USCG Academy Fireworks Entertainment display will be held on the Thames River in New London, CT.

Boys and Girls Club—Beach Ball 2015 fireworks display will be held on Bellport Bay, Bellport, NY.

Marina at American Wharf fireworks display will be held on the Thames River, Norwich, CT.

Cherry Grove Pride Week fireworks display will be held on Great South Bay, Cherry Grove, NY.

Village of Saltaire fireworks display will be held on Great South Bay, Bay Shore, NY.

Riverfest Fireworks display will be held on the Connecticut River, Hartford, CT.

This rule establishes eight special local regulations for four regattas, two swim events, one fireworks display, and one air show and six safety zones for six fireworks displays. The locations of these special regulated areas and safety zones are described in the regulatory text.

The fireworks displays will launch pyrotechnics from either a barge or a landsite near a waterway. A regulated area, specifically a safety zone, is required for each of these fireworks displays to protect both spectators and participants from the safety hazards created by the burning debris.

The special local regulation established for Aquapalooza includes two measures to reduce the risks to waterways users of Zach's Bay before, during, and after the event. The first measure restricts vessel movement within the regulated area to no wake speed or 6 knots, whichever is slower on July 26, 2015 from 11:30 a.m. to 8 p.m. The second measure restricts all vessel movement within the regulated area to the outbound or northbound direction on July 26, 2015 from 3 p.m. to 5:30 p.m.

Kayak for Camp is a rowing regatta that will take place in Norwalk Harbor near Norwalk, CT. This special local regulation proposes two temporary regulated areas to restrict vessel movement within the regulated areas of Norwalk Harbor to no wake speeds or 6 knots, whichever is slower.

Great Peconic Race regulated area would encompass all navigable waters of the United States of the Peconic River, Shelter Island, NY, inside two areas. This special local regulation proposes two temporary regulated areas in which event non-participants must travel at a no-wake speed and remain vigilant at all times for event participants. Additionally, recreational vessels must yield right-of-way for event participants and event safety craft, and follow directions given by event representatives during the event. Commercial vessels will have right-of-way over event participants and event safety craft.

Riverhead Rocks Triathlon incorporates swim legs that will place many swimmers in the navigable waters of the Peconic River. A regulated area is required to minimize the hazards posed by spectators and other waterway users operating their vessels in close proximity to the event participants. The special local regulation established for this swim event will minimize the risks to the event participants from this type of boat traffic and improve visibility and maneuverability for the safety vessels supporting the swim event.

Fran Schnarr Open Water Championship Swim will place many swimmers in the navigable waters of Huntington Harbor. A regulated area is required to minimize the hazards posed by spectators and other waterway users operating their vessels in close proximity to the event participants. The special local regulation established for this swim event will minimize the risks to the event participants from this type of boat traffic and improve visibility and maneuverability for the safety vessels supporting the swim event.

Jones Beach State Park fireworks display attracts thousands of spectator craft every year to Jones Beach State Park. Three regulated areas will be set to address the safety concerns with high vessel traffic. A “No Entry Area” will be set around the fireworks barge to ensure spectators maintain a safe distance from the barge. A “Slow/No Wake Area” will be set in the navigable waters between Meadow Brook State Parkway and Wantagh State Parkway. All vessels in the area will operate at “No Wake” speed or up to 6 knots, whichever is slower. A “No Southbound Traffic Area” will be set in all waters of Zach's Bay. No southbound vessel traffic will be allowed into or within this area.

Jones Beach Air Show involves numerous aircraft performing various aerial maneuvers which present multiple hazards, including those associated with in-flight accidents. This event attracts thousands of spectators and spectator craft which pose their own hazards. Three regulated areas will be set to address the safety concerns. A “Slow/No Wake Area” will be set in the navigable waters between Meadow Brook State Parkway and Wantagh State Parkway. All vessels in the area will operate at “No Wake” speed or up to 6 knots, whichever is slower. A “No Southbound Traffic Area” will be set in all waters of Zach's Bay. No southbound vessel traffic will be allowed into or within this area.

The special local regulation established for the Connecticut River Raft Race restricts vessel movement within the regulated area of the Connecticut River to no wake speed or 6 knots, whichever is slower, and also stipulates that vessels must not anchor, block, loiter, or impede the transit of event participants or official patrol vessels in the regulated areas unless authorized by COTP or designated representatives.

This rule prevents vessels from entering, transiting, mooring, or anchoring within areas specifically designated as safety zones and establishes additional vessel movement rules within areas specifically under the jurisdiction of the special local regulations during the periods of enforcement unless authorized by the COTP or designated representative.

Public notifications will be made to the local maritime community prior to each event through the Local Notice to Mariners and Broadcast Notice to Mariners.

We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on these statutes and executive orders.

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of Executive Order 12866 or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under those Orders.

The Coast Guard determined that this rulemaking is not a significant regulatory action for the following reasons: The enforcement of these regulated areas and safety zones will be relatively short in duration. Also, persons or vessels desiring entry into a regulated area or a deviance from the stipulations within a regulated area may be authorized to do so by the COTP Sector Long Island Sound or designated representative. Additionally, persons or vessels desiring to enter a safety zone may do so with permission from the COTP Sector Long Island Sound or designated representative. Furthermore, these special local regulations and safety zones are designed in a way to limit impacts on vessel traffic, permitting vessels to navigate in other portions of the waterways not designated as a regulated area or as a safety zone. Finally, to increase public awareness of these special local regulations and safety zones, the Coast Guard will notify the public of the enforcement of this rule via appropriate means, such as via Local Notice to Mariners and Broadcast Notice to Mariners.

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

This temporary final rule will affect the following entities, some of which may be small entities: The owners or operators of vessels intending to enter, transit, anchor, or moor within a regulated area or a safety zone during the periods of enforcement, from April 25, 2015 to September 20, 2015. However, this temporary final rule will not have a significant economic impact on a substantial number of small entities for the same reasons discussed in the Regulatory Planning and Review section.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT, above. The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

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

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and determined that this rule does not have implications for federalism.

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

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

This rule will not cause a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children.

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

This action is not a “significant energy action” under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use.

This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves the establishment of special local regulations and safety zones. This rule is categorically excluded from further review under paragraph 34(g) and (h) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated under ADDRESSES. We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR parts 100 and 165 as follows:

A. Public Participation and Request for Comments

We encourage you to participate in this rulemaking by submitting comments and related materials. All comments received will be posted, without change, to http://www.regulations.gov and will include any personal information you have provided.

If you submit a comment, please include the docket number for this rulemaking (USCG-2015-0271), indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online (http://www.regulations.gov), or by fax, mail or hand delivery, but please use only one of these means. If you submit a comment online via http://www.regulations.gov, it will be considered received by the Coast Guard when you successfully transmit the comment. If you fax, hand deliver, or mail your comment, it will be considered as having been received by the Coast Guard when it is received at the Docket Management Facility. We recommend that you include your name and a mailing address, an email address, or a phone number in the body of your document so that we can contact you if we have questions regarding your submission.

To submit your comment online, type the docket number [USCG-2015-0271] in the “SEARCH” box and click “SEARCH.” Click on “Submit a Comment” on the line associated with this rulemaking. If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 81/2 by 11 inches, suitable for copying and electronic filing. If you submit them by mail and would like to know that they reached the Facility, please enclose a stamped, self-addressed postcard or envelope. We will consider all comments and material received during the comment period and may change the rule based on your comments.

To view comments, as well as documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, type the docket number (USCG-2015-0271) in the “SEARCH” box and click “SEARCH.” Click on Open Docket Folder on the line associated with this rulemaking. You may also visit the Docket Management Facility in Room W12-140 on the ground floor of the Department of Transportation West Building, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Anyone can search the electronic form of comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review a Privacy Act notice regarding our public dockets in the January 17, 2008, issue of the Federal Register (73 FR 3316).

We do not now plan to hold a public meeting. But you may submit a request for one on or before June 16, 2015, using one of the four methods specified under ADDRESSES. Please explain why one would be beneficial. If we determine that one would aid this rulemaking, we will hold one at a time and place announced by a later notice in the Federal Register.

The bridge owner, FEC Railway, requested permission to operate the FEC Railroad Bridge across the New River with an automated system. The FEC Railroad Bridge in Fort Lauderdale, FL has a vertical clearance of 4 feet at mean high water in the closed position and horizontal clearance of 60 feet. Traffic on the waterway includes both commercial and recreational vessels.

Presently, in accordance with 33 CFR 117.5, the bridge is required to open on signal for the passage of vessels. The bridge is usually maintained in the open to navigation position and only closes for train traffic.

The bridge owner, FEC, determined that by installing an automated system, vessel transit will be more efficient. This automated system allows the railroad dispatcher to receive a signal that the bridge must close for approaching trains. The dispatcher will then be advised when trains clear the bridge so it can reopen.

Any vessel requesting a bridge opening must contact the bridge tender via telephone or radiotelephone (marine radio) on VHF-FM channel 9 or 16 to coordinate safe passage through the bridge. The tender must provide information to include, but not limited to authorization for the vessel to continue its transit when the bridge is open to navigation, or the tender must advise that the vessel will have to wait because a train is approaching. If a vessel is required to wait, the bridge tender must indicate the amount of time the vessel will have to wait until the train is clear of the bridge. The FEC Dispatch number and bridge tender phone number will be posted at the bridge so they can be seen by vessels approaching from either direction. The bridge tender's number is 305-889-5572 and the FEC Dispatch number is 800-342-1131.

This deviation seeks comments on FEC's operating schedule and tests an automatic operating system as the method for operating the bridge to determine whether a permanent change to operations can be approved. The deviation period will run from 6 a.m. on May 18, 2015 through 6 a.m. on October 16, 2015.

During the test deviation period, the draw of the FEC Railroad Bridge across the New River, mile 2.5, at Fort Lauderdale, FL, will operate as follows:

(a) The bridge is constantly tended.

(b) The bridge tender will utilize a VHF-FM radio to communicate on channels 9 and 16 and may be contacted by telephone at 305-889-5572.

(c) Signage will be posted displaying VHF radio contact information and the bridge tender and dispatch telephone number. A countdown clock for bridge closure shall be posted at the bridge site and visible for maritime traffic.

(d) A bridge log will be maintained including, at a minimum, bridge opening and closing times.

(e) When the draw is in the fully open position, green lights will be displayed to indicate that vessels may pass.

(f) When a train approaches, the lights go to flashing red and a horn starts four blasts, pauses, and then continues four blasts then the draw lowers and locks.

(g) After the train has cleared the bridge, the draw opens and the lights return to green.

(h) The bridge shall not be closed more than 60 minutes combined for any 120 minute time period beginning at 12:01 a.m.

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

TriMet Public Transit and Multnomah County have requested that the upper deck of the Steel Bridge and the Burnside Bridge remain in the closed-to-navigation position to accommodate the annual Rose Festival Parade event. The Steel Bridge, mile 12.1, and the Burnside Bridge, mile 12.4, both cross the Willamette River.

The Steel Bridge is a double-deck lift bridge with a lower lift deck and an upper lift deck which operate independent of each other. When both decks are in the down position the bridge provides 26 feet of vertical clearance. When the lower deck is in the up position, the bridge provides 71 feet of vertical clearance. This deviation does not affect the operating schedule of the lower deck which opens on signal.

The normal operating schedule for the upper deck of the Steel Bridge operates in accordance with 33 CFR 117.897(c)(3)(ii) which states from 8 a.m. to 5 p.m. Monday through Friday one hour advance notice shall be given for draw openings, and at all other times two hours advance notice shall be given to obtain an opening.

The Burnside Bridge provides a vertical clearance of 64 feet in the closed-to-navigation position. The normal operating schedule for the Burnside Bridge operates in accordance with 33 CFR 117.897(c)(3)(iii) which states from 8 a.m. to 5 p.m. Monday through Friday, one hour's notice shall be given for draw openings. At all other times, two hours notice is required. The Steel Bridge and Burnside Bridge clearances are above Columbia River Datum 0.0.

The deviation period is from 7 a.m. to 2 p.m. on June 6, 2015 to accommodate the route of the annual Rose Festival Parade event. The deviation allows the upper deck of the Steel Bridge, mile 12.1, and the Burnside Bridge, mile 12.4, both crossing the Willamette River, to remain in the closed-to-navigation position and need not open for maritime traffic from 7 a.m. to 2 p.m. on June 6, 2015. Waterway usage on this part of the Willamette River includes vessels ranging from commercial tug and barge to small pleasure craft.

Vessels able to pass through the Steel Bridge and Burnside Bridge in the closed positions may do so at anytime. The bridges will be able to open for emergencies and there is no immediate alternate route for vessels to pass. The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridges so that vessels can arrange their transits to minimize any impact caused by the temporary deviation.

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

The Coast Guard will enforce the safety zones established for Annual Fireworks Displays within the Captain of the Port, Puget Sound Area of Responsibility in 33 CFR 165.1332 during the dates and times noted below.

The following safety zones will be enforced from 5:00 p.m. on July 4, 2015 through 1:00 a.m. on July 5, 2015.

Background

Under Title VIII of the Alaska National Interest Lands Conservation Act (ANILCA) (16 U.S.C. 3111-3126), the Secretary of the Interior and the Secretary of Agriculture (Secretaries) jointly implement the Federal Subsistence Management Program. This program provides a preference for take of fish and wildlife resources for subsistence uses on Federal public lands and waters in Alaska. The Secretaries published temporary regulations to carry out this program in the Federal Register on June 29, 1990 (55 FR 27114), and published final regulations in the Federal Register on May 29, 1992 (57 FR 22940). The Program has subsequently amended these regulations a number of times. Because this program is a joint effort between Interior and Agriculture, these regulations are located in two titles of the Code of Federal Regulations (CFR): Title 36, “Parks, Forests, and Public Property,” and Title 50, “Wildlife and Fisheries,” at 36 CFR 242.1-242.28 and 50 CFR 100.1-100.28, respectively. The regulations contain subparts as follows: Subpart A, General Provisions; Subpart B, Program Structure; Subpart C, Board Determinations; and Subpart D, Subsistence Taking of Fish and Wildlife.

Consistent with subpart B of these regulations, the Secretaries established a Federal Subsistence Board to administer the Federal Subsistence Management Program. The Board comprises:

• A Chair appointed by the Secretary of the Interior with concurrence of the Secretary of Agriculture;

• The Alaska Regional Director, U.S. Fish and Wildlife Service;

• The Alaska Regional Director, U.S. National Park Service;

• The Alaska State Director, U.S. Bureau of Land Management;

• The Alaska Regional Director, U.S. Bureau of Indian Affairs;

• The Alaska Regional Forester, U.S. Forest Service; and

• Two public members appointed by the Secretary of the Interior with concurrence of the Secretary of Agriculture.

Through the Board, these agencies participate in the development of regulations for subparts C and D, which, among other things, set forth program eligibility and specific harvest seasons and limits.

In administering the program, the Secretaries divided Alaska into 10 subsistence resource regions, each of which is represented by a Regional Advisory Council. The Regional Advisory Councils provide a forum for rural residents with personal knowledge of local conditions and resource requirements to have a meaningful role in the subsistence management of fish and wildlife on Federal public lands in Alaska. The Council members represent varied geographical, cultural, and user interests within each region.

The Board addresses customary and traditional use determinations during the applicable biennial cycle. Section __.24 (customary and traditional use determinations) was originally published in the Federal Register on May 29, 1992 (57 FR 22940). The regulations at 36 CFR 242.4 and 50 CFR 100.4 define “customary and traditional use” as “a long-established, consistent pattern of use, incorporating beliefs and customs which have been transmitted from generation to generation. . . .” Since 1992, the Board has made a number of customary and traditional use determinations at the request of affected subsistence users. Those modifications, along with some administrative corrections, were published in the Federal Register as follows:

The Departments published a proposed rule on January 10, 2014 (79 FR 1791), to amend the fish section of subparts C and D of 36 CFR part 242 and 50 CFR part 100. The proposed rule opened a comment period, which closed on March 28, 2014. The Departments advertised the proposed rule by mail, radio, and newspaper, and comments were submitted via www.regulations.gov to Docket No. FWS-R7-SM-2013-0065. During that period, the Regional Councils met and, in addition to other Regional Council business, received suggestions for proposals from the public. The Board received a total of 18 proposals for changes to subparts C and D; this included one proposal that the Board had deferred from the previous regulatory cycle. After the comment period closed, the Board prepared a booklet describing the proposals and distributed it to the public. The proposals were also available online. The public then had an additional 30 days in which to comment on the proposals for changes to the regulations.

The 10 Regional Advisory Councils met again, received public comments, and formulated their recommendations to the Board on proposals for their respective regions. The Regional Advisory Councils had a substantial role in reviewing the proposed rule and making recommendations for the final rule. Moreover, a Council Chair, or a designated representative, presented each Council's recommendations at the Board's public meeting of January 21-23, 2015. These final regulations reflect Board review and consideration of Regional Advisory Council recommendations and public comments. The public received extensive opportunity to review and comment on all changes.

Of the 18 proposals, 10 were on the Board's regular agenda and 8 were on the consensus agenda. The consensus agenda is made up of proposals for which there is agreement among the affected Subsistence Regional Advisory Councils, a majority of the Interagency Staff Committee members, and the Alaska Department of Fish and Game concerning a proposed regulatory action. Any Board member may request that the Board remove a proposal from the consensus agenda and place it on the non-consensus (regular) agenda. The Board votes en masse on the consensus agenda after deliberation and action on all other proposals.

Of the proposals on the consensus agenda, the Board adopted one, adopted one with modification, took no action on one, and rejected five. The adopted consensus proposals are reflected in the rule portion of this document and consist of the addition of a definition to § ___.25 and the addition of the last two subparagraphs in § __.27 ((e)(13)(xx) and (xxi)). Analysis and justification for each action are available for review at the Office of Subsistence Management, 1011 East Tudor Road, Mail Stop 121, Anchorage, AK 99503, or on the Office of Subsistence Management Web site (http://www.doi.gov/subsistence/index.cfm). Of the proposals on the regular agenda, the Board adopted three; adopted two with modification; rejected two; and took no action on three.

The Board rejected or took no action on five non-consensus proposals. The rejected proposals were recommended for rejection by one or more of the Regional Advisory Councils unless noted below.

The Board rejected a proposal to restrict the use of driftnets in selected districts of the Yukon River. This action would have been unnecessarily restrictive to subsistence users and was not supported by substantial evidence. This action was supported by three Councils and contrary to the recommendation of one Council.

The Board took no action on one proposal to allow the use of dipnets with provisions to require the release of Chinook salmon. This decision was based on the Board's earlier action on a similar proposal allowing the use of dipnets.

The Board rejected a proposal to require the immediate recording of harvested Steelhead on Prince of Wales Island, because the in-season manager could include the provision as a permit condition.

The Board took no action on two proposals for the Stikine River. One proposal requested to change the subsistence Sockeye salmon annual guideline harvest level, and the second requested a requirement to check the nets every 2 hours. These decisions were based on its earlier action on a similar proposal requiring nets to be checked twice daily and eliminating the harvest level.

The Board adopted or adopted with modification five non-consensus proposals. Modifications were suggested by the affected Regional Council(s), developed during the analysis process, or developed during the Board's public deliberations. All of the adopted proposals were recommended for adoption by at least one of the Regional Councils unless noted below.

The Board adopted a proposal to allow the use of dipnets for the harvest of salmon on the Kuskokwim River. This action provides subsistence users an additional gear type that could be used when gillnet restrictions are in place for conservation concerns.

The Board adopted a proposal with modification to establish an experimental community gillnet fishery on the Kasilof River for the residents of Ninilchik. This action provides additional opportunity for subsistence users.

The Board adopted a proposal to establish a community gillnet fishery on the Kenai River for the residents of Ninilchik. This action provides additional opportunity for subsistence users.

The Board adopted with modification a proposal requiring nets to be checked twice daily and eliminating the guideline harvest limits on the Stikine River. The change of the guideline harvest levels will require amending the Pacific Salmon treaty, and final implementation is contingent upon review and approval by the Transboundary Panel of the U.S./Canada Pacific Salmon Commission and approval by the Pacific Salmon Commission.

The Board adopted a proposal to close Federal public waters to non-Federally qualified users in the Makhnati Island area to the harvest of herring and herring spawn. This closure was enacted for potential conservation concerns and to protect subsistence uses. This action varied from the Council recommendation, yet met its intent.

These final regulations reflect Board review and consideration of Regional Council recommendations and public and Tribal comments. Because this rule concerns public lands managed by an agency or agencies in both the Departments of Agriculture and the Interior, identical text will be incorporated into 36 CFR part 242 and 50 CFR part 100.

The Board has provided extensive opportunity for public input and involvement in compliance with Administrative Procedure Act requirements, including publishing a proposed rule in the Federal Register, participation in multiple Regional Council meetings, additional public review and comment on all proposals for regulatory change, and opportunity for additional public comment during the Board meeting prior to deliberation. Additionally, an administrative mechanism exists (and has been used by the public) to request reconsideration of the Board's decision on any particular proposal for regulatory change (36 CFR 242.20 and 50 CFR 100.20). Therefore, the Board believes that sufficient public notice and opportunity for involvement have been given to affected persons regarding Board decisions.

In the more than 25 years that the Program has been operating, no benefit to the public has been demonstrated by delaying the effective date of the subsistence regulations. A lapse in regulatory control could affect the continued viability of fish or wildlife populations and future subsistence opportunities for rural Alaskans, and would generally fail to serve the overall public interest. Therefore, the Board finds good cause pursuant to 5 U.S.C. 553(d)(3) to make this rule effective upon the date set forth in DATES to ensure continued operation of the subsistence program.

A Draft Environmental Impact Statement that described four alternatives for developing a Federal Subsistence Management Program was distributed for public comment on October 7, 1991. The Final Environmental Impact Statement (FEIS) was published on February 28, 1992. The Record of Decision (ROD) on Subsistence Management for Federal Public Lands in Alaska was signed April 6, 1992. The selected alternative in the FEIS (Alternative IV) defined the administrative framework of an annual regulatory cycle for subsistence regulations.

The following Federal Register documents pertain to this rulemaking:

A 1997 environmental assessment dealt with the expansion of Federal jurisdiction over fisheries and is available at the office listed under FOR FURTHER INFORMATION CONTACT. The Secretary of the Interior, with concurrence of the Secretary of Agriculture, determined that expansion of Federal jurisdiction does not constitute a major Federal action significantly affecting the human environment and, therefore, signed a Finding of No Significant Impact.

An ANILCA section 810 analysis was completed as part of the FEIS process on the Federal Subsistence Management Program. The intent of all Federal subsistence regulations is to accord subsistence uses of fish and wildlife on public lands a priority over the taking of fish and wildlife on such lands for other purposes, unless restriction is necessary to conserve healthy fish and wildlife populations. The final section 810 analysis determination appeared in the April 6, 1992, ROD and concluded that the Program, under Alternative IV with an annual process for setting subsistence regulations, may have some local impacts on subsistence uses, but will not likely restrict subsistence uses significantly.

During the subsequent environmental assessment process for extending fisheries jurisdiction, an evaluation of the effects of this rule was conducted in accordance with section 810. That evaluation also supported the Secretaries' determination that the rule will not reach the “may significantly restrict” threshold that would require notice and hearings under ANILCA section 810(a).

An agency may not conduct or sponsor and you are not required to respond to a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. This rule does not contain any new collections of information that require OMB approval. OMB has reviewed and approved the collections of information associated with the subsistence regulations at 36 CFR part 242 and 50 CFR part 100, and assigned OMB Control Number 1018-0075, which expires February 29, 2016.

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.

The Regulatory Flexibility Act of 1980 (5 U.S.C. 601 et seq.) requires preparation of flexibility analyses for rules that will have a significant effect on a substantial number of small entities, which include small businesses, organizations, or governmental jurisdictions. In general, the resources to be harvested under this rule are already being harvested and consumed by the local harvester and do not result in an additional dollar benefit to the economy. However, we estimate that two million pounds of meat are harvested by subsistence users annually and, if given an estimated dollar value of $3.00 per pound, this amount would equate to about $6 million in food value Statewide. Based upon the amounts and values cited above, the Departments certify that this rulemaking will not have a significant economic effect on a substantial number of small entities within the meaning of the Regulatory Flexibility Act.

Under the Small Business Regulatory Enforcement Fairness Act (5 U.S.C. 801 et seq.), this rule is not a major rule. It does not have an effect on the economy of $100 million or more, will not cause a major increase in costs or prices for consumers, and does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises.

Title VIII of ANILCA requires the Secretaries to administer a subsistence priority on public lands. The scope of this Program is limited by definition to certain public lands. Likewise, these regulations have no potential takings of private property implications as defined by Executive Order 12630.

The Secretaries have determined and certify pursuant to the Unfunded Mandates Reform Act, 2 U.S.C. 1502 et seq., that this rulemaking will not impose a cost of $100 million or more in any given year on local or State governments or private entities. The implementation of this rule is by Federal agencies and there is no cost imposed on any State or local entities or tribal governments.

The Secretaries have determined that these regulations meet the applicable standards provided in sections 3(a) and 3(b)(2) of Executive Order 12988, regarding civil justice reform.

In accordance with Executive Order 13132, the rule does not have sufficient Federalism implications to warrant the preparation of a Federalism summary impact statement. Title VIII of ANILCA precludes the State from exercising subsistence management authority over fish and wildlife resources on Federal lands unless it meets certain requirements.

The Alaska National Interest Lands Conservation Act, Title VIII, does not provide specific rights to tribes for the subsistence taking of wildlife, fish, and shellfish. However, the Board provided Federally recognized Tribes and Alaska Native corporations opportunities to consult on this rule. Consultation with Alaska Native corporations are based on Public Law 108-199, div. H, Sec. 161, Jan. 23, 2004, 118 Stat. 452, as amended by Public Law 108-447, div. H, title V, Sec. 518, Dec. 8, 2004, 118 Stat. 3267, which provides that: “The Director of the Office of Management and Budget and all Federal agencies shall hereafter consult with Alaska Native corporations on the same basis as Indian tribes under Executive Order No. 13175.”

The Secretaries, through the Board, provided a variety of opportunities for consultation: Commenting on proposed changes to the existing rule; engaging in dialogue at the Regional council meetings; engaging in dialogue at the Board's meetings; and providing input in person, by mail, email, or phone at any time during the rulemaking process.

On January 21, 2015, the Board provided Federally recognized Tribes and Alaska Native Corporations a specific opportunity to consult on this rule prior to the start of its public regulatory meeting. Federally recognized Tribes and Alaska Native Corporations were notified by mail and telephone and were given the opportunity to attend in person or via teleconference.

This Executive Order requires agencies to prepare Statements of Energy Effects when undertaking certain actions. However, this rule is not a significant regulatory action under E.O. 13211, affecting energy supply, distribution, or use, and no Statement of Energy Effects is required.

Theo Matuskowitz drafted these regulations under the guidance of Eugene R. Peltola, Jr. of the Office of Subsistence Management, Alaska Regional Office, U.S. Fish and Wildlife Service, Anchorage, Alaska. Additional assistance was provided by

• Daniel Sharp, Alaska State Office, Bureau of Land Management;

• Mary McBurney, Alaska Regional Office, National Park Service;

• Dr. Glenn Chen, Alaska Regional Office, Bureau of Indian Affairs;

• Trevor T. Fox, Alaska Regional Office, U.S. Fish and Wildlife Service; and

• Thomas Whitford, Alaska Regional Office, U.S. Forest Service.

For the reasons set out in the preamble, the Federal Subsistence Board amends title 36, part 242, and title 50, part 100, of the Code of Federal Regulations, as set forth below.

Table of Contents I. General Information II. Background III. What was the State's process? IV. EPA's Evaluation of Utah Rule R307-311 V. EPA's Evaluation of the Technical Support Document for R307-311 VI. Consideration of Section 110(l) of the Clean Air Act VII. Final Action VIII. Incorporation by Reference IX. Statutory and Executive Order Reviews I. General Information

1. Submitting CBI. Do not submit CBI to EPA through http://www.regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

2. Tips for Preparing Your Comments. When submitting comments, remember to:

a. Identify the rulemaking by docket number and other identifying information (subject heading, Federal Register date and page number).

b. Follow directions—The agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.

c. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.

d. Describe any assumptions and provide any technical information and/or data that you used.

e. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.

f. Provide specific examples to illustrate your concerns, and suggest alternatives.

g. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.

h. Make sure to submit your comments by the comment period deadline identified.

In this action, we are approving and soliciting public comment regarding the Governor's March 9, 2015, submittal of Utah's new Rule R307-311 for adoption into the Utah SIP. The rule will allow certain trading of MVEBs for the purposes of transportation conformity for PM10 for Utah County. Once approved by EPA, the Mountainland Association of Governments (MAG) will then be able to use the provisions of Rule R307-311 when MAG performs a transportation conformity determination for its Regional Transportation Plan (RTP) and/or Transportation Improvement Program (TIP).

The above SIP action that was adopted by the Utah Air Quality Board (UAQB), and subsequently submitted to EPA by the Governor of Utah for approval, is discussed in greater detail in sections III, IV, and V below. We also discuss the state's associated technical support document (TSD), which gives technical information to support new Rule R307-311.

Sections 110(a)(2) and 110(l) of the CAA requires that a state provide reasonable notice and public hearing before adopting a SIP revision and submitting it to us. More detailed requirements for notice and public hearing are set out in 40 CFR 51.102.

On December 4, 2014 the UAQB proposed for public comment amendments to the Utah SIP for Utah Air Quality Rule R307-311; “Utah County: Trading of Emission Budgets for Transportation Conformity.” In addition on January 12, 2015, the Utah Division of Air Quality (UDAQ) made the proposed TSD available for public comment and extended the Rule R307-311 public comment period to February 12, 2015. EPA notes that included with the state's administrative documentation for this SIP and Rule revision was a letter memorandum, DAQ-010-15 dated February 19, 2015, from Bryce Bird, Director, UDAQ to the UAQB. This letter memorandum indicated that a public comment period was held from January 1, 2015 through February 12, 2015 regarding the proposed Rule R307-311 SIP revisions. The UDAQ February 19, 2015 letter memorandum noted that no public comments were received on the proposed rule R307-311, but that EPA did comment on the TSD. UDAQ summarized and responded to EPA's comments in its February 19, 2015 letter memorandum to the UAQB. In addition, UDAQ noted that no public hearings were requested. In consideration of the February 19, 2015 UDAQ letter memorandum, the UAQB subsequently adopted the proposed Rule R307-311, and a revised TSD, on March 4, 2015. The SIP Rule revision became state effective on March 5, 2015 and was submitted by the Governor to EPA by a letter dated March 9, 2015. By a subsequent letter dated March 11, 2015, Bryce Bird, Director, UDAQ submitted the necessary administrative documentation that supported the Governor's submittal.

We have evaluated Utah's March 9, 2015 SIP submittal and the March 11, 2015 submitted administrative documentation and have determined that the state met the requirements for reasonable notice and public hearing under section 110(a)(2) of the CAA. By a letter dated March 24, 2015, we advised the state that the SIP submittal was complete under section 110(k)(1)(B) of the Act, because the submittal met the minimum “completeness” criteria found in 40 CFR part 51, Appendix V.

Transportation conformity is required by section 176 of the CAA to ensure that federally supported highway and transit project activities are consistent with (“conform to”) the purpose of a SIP. Conformity to the purpose of the SIP means that transportation activities will not cause new air quality violations, worsen existing violations, or delay timely attainment of the national ambient air quality standards (NAAQS). EPA's transportation conformity rule establishes the criteria and procedures for determining whether transportation activities conform to the state air quality plan.

One key provision of EPA's transportation conformity rule (see 40 CFR part 93, subpart A) requires a demonstration that emissions from the RTP and TIP are consistent with the MVEB in the applicable SIP (40 CFR 93.118 and 93.124). The transportation conformity MVEB is defined as the level of on-road mobile source emissions relied upon in the SIP to attain or maintain compliance with the NAAQS in the nonattainment or maintenance area.

In this particular instance, the NAAQS involved is PM10, the nonattainment area is Utah County, the MVEBs involve direct emissions of PM10 and NOX, the latter as a precursor to the formation of PM10, and the applicable SIP is the EPA-approved Utah PM10 attainment plan, as updated on December 23, 2002 (67 FR 78181). The approved PM10 attainment plan contains (among other things) an attainment demonstration for Utah County that sets PM10 and NOX MVEBs.

Transportation conformity is demonstrated when future year's projected on-road mobile source's emissions, for a particular pollutant or precursor, are estimated to be at or below the on-road motor vehicle's emissions budget for that pollutant or precursor in the applicable SIP. For the PM10 NAAQS for Utah County, conformity must be demonstrated separately for the PM10 and NOX MVEBs established in the Utah County PM10 attainment demonstration. However, emissions can be traded between the PM10 and NOX budgets if there is an approved rule in the SIP that establishes appropriate mechanisms for such trades. See 40 CFR 93.124(b).

Currently, the Utah SIP does not contain an approved rule that establishes an appropriate mechanism for trading of emissions between the PM10 and NOX MVEBs for Utah County. The EPA notes, however, that we previously approved a Utah Rule (R307-310) that allows trading of emissions between the PM10 and NOX MVEBs for another PM10 nonattainment area in Utah, Salt Lake County. 67 FR 44065 (July 1, 2002). For Utah County, the state has developed a new Rule R307-311, very similar to that for Salt Lake County, which establishes an on-road mobile source emissions trading mechanism that; (1) involves only PM10 and NOX MVEBs from the PM10 attainment demonstration SIP, (2) allows trading in only one direction from the PM10 budget to the NOX budget on a one-to-one basis, (3) applies only to transportation conformity determinations in Utah County in conjunction with the PM10 attainment demonstration SIP, and (4) is pursuant to 40 CFR part 93, subpart A.

An overview of all portions of the state's new Rule R307-311 is provided below:

1. R307-311 is entitled “Utah County: Trading of Emission Budgets for Transportation Conformity.”

2. R307-311-1 “Purpose.” The stated purpose of this new rule is:

This rule establishes the procedures that may be used to trade a portion of the primary PM10 budget when demonstrating that a transportation plan, transportation improvement program, or project conforms with the motor vehicle emissions budgets in the Utah County portion of Section IX, Part A of the State Implementation Plan, “Fine Particulate Matter (PM10).

3. R307-311-2. “Definitions.” This section provides applicable definitions:

The definitions contained in 40 CFR 93.101, effective as of the date referenced in R307-101-3,1 are incorporated into this rule by reference. The following additional definitions apply to this rule.

“Budget” means the motor vehicle emission projections used in the attainment demonstration in the Utah County portion of Section IX, Part A of the State Implementation Plan, “Fine Particulate Matter (PM10).

“NOX” means oxides of nitrogen.

“Primary PM10” means PM10 that is emitted directly by a source. Primary PM10 does not include particulate matter that is formed when gaseous emissions undergo chemical reactions in the ambient air.

“Transportation Conformity” means a demonstration that a transportation plan, transportation improvement program, or project conforms with the emissions budgets in a state implementation plan, as outlined in 40 CFR, Chapter 1, Part 93; 2 Determining Conformity of Federal Actions to State or Federal Implementation Plans.

4. R307-311-3. “Applicability”. This portion of the rule defines its applicability. EPA notes that this rule may only be applied to Utah County and only for PM10:

(A) This rule applies to agencies responsible for demonstrating transportation conformity with the Utah County portion of Section IX, Part A of the State Implementation Plan, “Fine Particulate Matter (PM10).

(B) This rule does not apply to emission budgets from Section IX, Part C.6 of the State Implementation Plan, “Carbon Monoxide Maintenance Provisions.

5. R307-311-4. “Trading Between Emission Budgets.” This portion of the rule specifies the trading mechanism and provides the trading ratio of NOX and PM10. In our section V below, EPA evaluates the technical justification provided in the TSD for the trading ratio. In this section, we find that the rule language establishes an appropriate trading mechanism for the Utah County NOX and PM10 motor vehicle emission budgets:

The agencies responsible for demonstrating transportation conformity are authorized to supplement the budget for NOX with a portion of the budget for primary PM10 for the purpose of demonstrating transportation conformity for NOX. The NOX budget shall be supplemented using the following procedures.

(a) The metropolitan planning organization shall include the following information in the transportation conformity demonstration:

(i) The budget for primary PM10 and NOX for each required year of the conformity demonstration, before trading allowed by this rule has been applied;

(ii) The portion of the primary PM10 budget that will be used to supplement the NOX budget, specified in tons per day using a 1:1 ratio of primary PM10 to NOX, for each required year of the conformity demonstration;

(iii) The remainder of the primary PM10 budget that will be used in the conformity demonstration for primary PM10, specified in tons per day for each required year of the conformity demonstration; and

(iv) The budget for primary PM10 and NOX for each required year of the conformity demonstration after the trading allowed by this rule has been applied.

(b) Transportation conformity for NOX shall be demonstrated using the NOX budget supplemented by a portion of the primary PM10 budget as described in (a)(ii). Transportation conformity for primary PM10 shall be demonstrated using the remainder of the primary PM10 budget described in (a)(iii).

(c) The primary PM10 budget shall not be supplemented by using a portion of the NOX budget.

The Governor's SIP revision submittal provided a TSD to support the new Rule R307-311 and address MVEB trading, as contemplated by 40 CFR 93.124(b), for PM10 and NOX in Utah County.

PM10 is particulate matter with diameters smaller than 10 micrometers. PM10 consists of solid and/or liquid particles of; (1) primary particles that are directly emitted particulate matter (PM) or PM that quickly condenses upon release, and (2) secondary particles which are PM that is formed in the atmosphere from gaseous precursors. Important gaseous precursors to PM include sulfur dioxide (SO2) which converts to sulfate (SO4) particles, NOX which converts to nitrate (NO3) particles, volatile organic compounds (VOCs) some of which convert to secondary organic aerosols, and ammonia (NH3) which adds to the mass of sulfate PM and allows nitric acid to convert to PM10 in the form of ammonium nitrate.

Currently in Utah County, the RTP and TIP must demonstrate conformity to the MVEBs for PM10 and NOX that were derived from the 2002 EPA-approved PM10 attainment demonstration SIP (see 67 FR 78181, December 23, 2002). Since the regulatory goal is to achieve and maintain attainment of the NAAQS and conformity related to total PM10, not individual components, it should not matter in the conformity analysis whether PM10 consists of directly emitted (primary) PM10 or secondary nitrate PM10 formed in the atmosphere from precursor NOX gas emissions, provided the MVEBs for PM10 and NOX are consistent with the SIP's demonstration of attainment. The state's TSD outlines the scientific rationale for why excess NOX motor vehicle emissions (above the NOX MVEB level) can be offset, on a 1 to 1 basis, with available motor vehicle PM10 emissions (below the PM10 MVEB level). The State's TSD explains why the provisions of Rule R307-311 are considered conservative (i.e., protective of the environment) in that the Rule only allows a one-way direction trading of the MVEBs and a trading ratio of only 1 to 1.

The state's TSD describes how each ton of gaseous NOX that gets converted to PM10 creates more than a ton of PM10 because the molecular weight of ammonium nitrate PM10 is greater than the molecular weight of NOX gaseous emissions. Considering the ratio of the molecular weights of the NOX precursor gas and the resulting ammonium nitrate aerosol (PM10), the state notes that a ton of NOX that is converted from a gas to a particle can form as much as 1.74 tons of PM10.

However, not all NOX emissions are converted because it takes time to convert NOX to nitric acid (HNO3), which is the necessary gaseous precursor to ammonium nitrate PM10. These reactions generally occur at rates of 1 to 10 percent per hour. It would take approximately at least 10 hours to fully convert to nitric acid. After this initial conversion, only a fraction of the gaseous nitric acid will condense as ammonium nitrate PM10, depending on equilibrium considerations. Finally, during the gas-to-particle conversion process, deposition will remove a significant amount of material. Throughout this process of NOX conversion to nitric acid, and then to PM10 and deposition, an equivalent amount of directly emitted PM10 is having a much larger effect on the PM10 concentration. Directly emitted PM10 has an effect on the ambient concentration immediately upon its release, while NOX emissions require hours to have an effect.

From a historical perspective, the conversion of NOX to PM10 has been discussed at EPA since at least 1996. In our 1996 proposed rule to revise the regulations for the Prevention of Significant Deterioration (PSD) and nonattainment New Source Review (NSR) programs, we discussed a proposed approach for interpollutant trading for PM10 offsets in the nonattainment NSR program:

These statements were cited in our 2002 proposed approval of the MVEB trading rule (R307-310) for Salt Lake County. 67 FR 21609 (May 1, 2002).

However, EPA has more recently issued guidance on interpollutant trading provisions for fine particulate matter (PM2.5) for offsets under the nonattainment NSR program. The guidance memorandum is entitled “Revised Policy to Address Reconsideration of Interpollutant Trading Provisions for Fine Particles (PM2.5)” and is dated July 21, 2011 (hereafter referred to as “Revised 2011 Trading Policy”). The Revised 2011 Trading Policy states in part (page 3, fourth paragraph) that “. . . states will be expected to develop separate PM2.5 precursor offset ratios that are demonstrated to be suitable for addressing the particular precursor's relationship with ambient PM2.5 concentrations for 24-hour averaging periods that are causing violations in that nonattainment area.” And on page 4, first paragraph; “. . . each ratio will need to be supported by modeling or other technical demonstration to show that such ratio is suitable for the particular PM2.5 nonattainment area of concern . . .”

Our Revised 2011 Trading Policy provides a general framework for such efforts, involving the following steps:

1. Definition of the appropriate geographical area.

2. Sensitivity runs with appropriate air quality models.

3. Calculation of interpollutant ratios.

4. Quality assurance of the results.

To support Utah's rule R307-311, the UDAQ applied the above methodology to the Utah County 24-hour PM10 NAAQS nonattainment area. Although the Revised 2011 Trading Policy is specific to PM2.5 and nonattainment NSR offsets, and is nonbinding guidance, in this action we consider that the recommendations in the Revised 2011 Trading Policy provide a suitable approach for a technical demonstration that the trading ratio for Utah County for the PM10 and NOX MVEBs is appropriate under 40 CFR 93.124(b).

The UDAQ states in the TSD that exceedances of the PM10 24-hour NAAQS in Utah County are characterized by spikes in secondary aerosol formation under conditions of wintertime temperature inversions which prevent good atmospheric mixing and facilitate conversion of secondary PM10. The UDAQ also states that a high percentage of the PM10 monitored in Utah County, during winter episodes of elevated concentration, lies also within the PM2.5 fraction. EPA also notes that the 2002 Utah County PM10 SIP revision identified both NOX and SO2 as precursors to the formation of PM10.

The TSD for Rule R307-311 identifies that parts of Utah County (the valley regions, western area of the County) are also designated as nonattainment for the 2006 24-hour PM2.5 NAAQS (74 FR 58688, November 13, 2009). To meet the requirements set out in subparts 1 and 4 of Part D, title I of the CAA, the UDAQ developed a moderate area attainment plan for Utah County that (among other things) contained a demonstration that attainment of the 24-hour PM2.5 standards by the applicable attainment date for moderate areas, December 31, 2015, is impracticable (hereafter “PM2.5 Impracticability Demonstration”). This attainment plan was submitted by the Governor to EPA on December 16, 2014. The air quality modeling for the PM2.5 Impracticability Demonstration was conducted by UDAQ using the Community Multi-Scale Air Quality model (CMAQ). CMAQ is also capable of determining the relative importance of NOX and PM10 in contributing to PM10 nonattainment.

The emission inventories that were developed by UDAQ for the Utah County PM2.5 Impracticability Demonstration included PM2.5, SO2, NOX, VOC, Ammonia and PM10.3 As PM10 was inventoried for the PM2.5 Impracticability Demonstration, this allowed CMAQ model sensitivity runs to be made for the purpose of evaluating and supporting the MVEB trading provisions in Rule R307-311. The UDAQ's methodology employed the CMAQ model, as developed for Utah County, with a substitution of PM10 emissions for PM2.5. The UDAQ also notes in the Rule R307-311 TSD that the CMAQ model was re-validated with respect to PM10 emissions data from the appropriate episode period prior to making the sensitivity runs (refer to Appendix A of the TSD).

Having made these adjustments to the CMAQ model, UDAQ ran the model to generate a time-series plot (refer to Appendix A of the TSD). The UDAQ determined that the ratio of NOX to PM10 equivalence was 5.702 to one. Since this ratio is considerably greater than 1:1, the UDAQ concluded that reducing primary PM10 is more beneficial than reducing NOX for improving Utah County's air quality with respect to PM10. The EPA has evaluated this additional sensitivity modeling information and has concluded that it provides an adequate technical demonstration to support the MVEB trading provisions in Rule R307-311. Based on the demonstration, we also conclude that Rule R307-311 establishes an appropriate trading ratio, and that under Rule R307-311, there will not be adverse impacts to the overall ambient 24-hour PM10 concentrations within Utah County.

With regard to ambient 24-hour PM10 concentrations within Utah County, we have also evaluated the current (state-certified) 2011 through 2013 PM10 ambient air quality monitoring data for Utah County in EPA's Air Quality System (AQS), EPA's repository for the Nation's ambient air quality data. EPA's guidance for the calculation of 24-hour PM10 design value concentrations provide four techniques.4 Our guidance's “Table Lookup” method shows a 2011 through 2013 PM10 design value concentration as 149μm3 at the North Provo monitor and 124μm3 at the Lindon monitor. These values, however, contain certain data quality issues such as missing days of monitoring data and zero reading days. We believe that if the statistical method from our guidance, “Using the empirical frequency distribution of several years of the data (graphical estimation),” is used, in this particular case it provides a more accurate representation of the monitoring data.5 When using this statistical/graphic approach, the North Provo monitor then has a 2011 through 2013 PM10 design value concentration of 133.5 µm3 and the Lindon monitor has a 2011 through 2013 design value concentration of 118.7 µm3. However, EPA notes that regardless of the methodology used, Utah County continues to demonstrate attainment of the 24-hour PM10 NAAQS.

Section 110(1) of the CAA states that a SIP revision cannot be approved if the revision would interfere with any applicable requirement concerning attainment and reasonable further progress towards attainment of a NAAQS or any other applicable requirement of the CAA. EPA's evaluation above shows that this SIP revision will not interfere with attainment of the PM10 NAAQS.

In addition to being a designated nonattainment area for PM10, Utah County is also designated as nonattainment for the 2006 24-hour PM2.5 NAAQS. The city of Provo, in Utah County, is designated as an attainment/maintenance area for carbon monoxide (CO). These criteria pollutants, along with the 2008 8-hour ozone NAAQS and the 1-hour nitrogen dioxide (NO2) NAAQS, were evaluated by the state in the TSD for potential collateral impacts from the implementation of the provisions of Rule R307-311.

As discussed above, part of Utah County (the western portion) was designated by EPA as nonattainment for the 2006 24-hour PM2.5 NAAQS (74 FR 58688, November 13, 2009), and on December 16, 2014, the state submitted an attainment plan containing, among other things, the PM2.5 Impracticability Demonstration. As with PM10 (described above), UDAQ performed sensitivity runs using the CMAQ modeling information that was developed for the PM2.5 Impracticability Demonstration. This modeling exercise was performed in order to determine an equivalence ratio between NOX and PM2.5. The resulting ratio of NOX to PM2.5 was determined by the UDAQ to be 13.09 to 1.0. Similar to the result for PM10, the ratio is greater than one to one, and illustrates that reducing primary PM2.5 is more beneficial than reducing the same quantity of NOX.

However, Rule R307-311 provides for reductions in PM10, and generally speaking, a reduction in PM10 is not necessarily a reduction in PM2.5. So that the above PM2.5 to NOX ratio could support a determination that Rule R307-311 would not have an adverse impact on overall PM2.5 concentrations in Utah County, the UDAQ considered the physical make-up of PM10 emissions from on-road mobile sources in Utah County. The following table, presenting information from the TSD, considers PM emissions as they were inventoried for calendar year 2015 in the PM2.5 Impracticability Demonstration for the Utah County PM2.5 nonattainment area:

As derived from the state's information and as presented in Table 1 above, for every ton of PM10 emissions due to on-road mobile sources, 0.409 tons would be composed of PM2.5. The provisions of Rule R307-311 would allow a one-ton increase in NOX emissions that would be offset by a one-ton decrease in the PM10 emissions. Based on the information in the above table, the state concluded that a one-ton increase in NOX emissions would be offset by a 0.409-ton decrease in PM2.5 emissions. To illustrate, using the 1:0.409 ratio and the equivalence ratio of 13.09:1 for NOX to PM2.5, a 13 ton increase in NOX emissions would equal a 1 ton increase of PM2.5 emissions. However, applying the 1 to 1 trading ratio with PM10 would then require a 13 ton PM10 emissions decrease which is a 5.3 ton (13 x 0.409) PM2.5 emissions decrease. This example results in a net 4.3 ton decrease in PM2.5 emissions.

Based on this 1:0.409 ratio and the equivalence ratio of 13.09:1 for NOX to PM2.5, the EPA can, therefore, agree with the state and conclude that Rule R307-311, with its requirements to allow the trading of the PM10 budget to the NOX budget in one direction only at a ratio of 1:1, would not have an adverse impact on overall ambient 24-hour PM2.5 concentrations within Utah County.

The EPA notes that additional supporting information was provided in the PM2.5 Impracticability Demonstration as it included an emission inventory of NOX emissions for calendar year 2015. The PM2.5 Impracticability Demonstration notes that on-road mobile sources in Utah County are expected to account for 21.48 tons per winter weekday in 2015. The on-road mobile sources emissions were calculated using EPA's Motor Vehicle Emission Simulator (MOVES) model and the MOVES2010a version. This estimate is greater than the combined sum of the 2020 MVEBs for both PM10 and NOX contained in the EPA-approved 2002 SIP revision. To demonstrate, even if the entire PM10 MVEB was traded to increase the NOX MVEB as a result of the application of Rule R307-311, the resulting total NOX emissions would still be less than the 2015 estimated NOX emissions contained in the PM2.5 Impracticability Demonstration.

As noted previously, the Provo-Orem area is a CO attainment/maintenance area (70 FR 66264, November 2, 2005). EPA notes that NOX emissions do not act as a precursor to carbon monoxide; therefore, EPA has concluded that the application of the provisions of R307-311 will not impact the Provo-Orem CO maintenance plan or attainment of the CO NAAQS. The state notes in the Rule R307-311 TSD that CO maintenance plan has its own CO MVEB which has been set at a level demonstrated to keep the Provo-Orem area in attainment with the CO standard. The provisions of Rule R307-311 do not change the maintenance plan's CO MVEB.

For purposes of completeness, the state provided recent CO ambient air quality monitoring data in the Rule R307-311 TSD. These data have been excerpted by EPA and are provided in the table below:

As can be seen in Table 2 above, the Provo area continues to demonstrate compliance with both the CO Annual and CO 8-hour NAAQS.

The EPA notes that NOX emissions are a precursor to the formation of ground level ozone, PM2.5, and PM10. With regard to ozone, we also note that Utah County has never been designated as nonattainment for any applicable ozone NAAQS. The current, applicable ozone NAAQS is the 2008 8-hour ozone NAAQS and Utah County was designated by EPA as unclassifiable/attainment for that NAAQS (77 FR 30088, May 21, 2012). Thus, the state has not had to develop an ozone attainment plan or maintenance plan for Utah County.

To assess the potential impacts to Utah County's continued attainment of the 2008 8-hour ozone NAAQS, EPA considered ozone ambient air quality monitoring data for Utah County and predicted future-year NOX emission reductions from motor vehicles.

The state provided recent ozone air quality monitoring data in the Rule R307-311 TSD. EPA has excerpted that information from the TSD and presents those data in Table 3 below:

As can be seen in Table 3 above, Utah County continues to demonstrate compliance with 2008 8-hour ozone NAAQS.

The provisions of Rule R307-311 would allow for an increase in the Utah County PM10 SIP's NOX MVEB. However, EPA believes that regardless of this potential increase in the NOX MVEB, overall future NOX emissions from mobile sources will significantly decrease not only in Utah County, but in the nation as a whole. On April 28, 2014, we published a final rule adopting new Tier 3 emission standards and fuel requirements for motor vehicles and for motor vehicle fuels (79 FR 23414).

Our April 28, 2014 final rule included new Tier 3 emission standards to reduce exhaust and evaporative emissions from light-duty vehicles, light-duty trucks, and heavy-duty vehicles up to 14,000 pounds Gross Vehicle Weight Rating. In addition, the final rule specified corresponding changes to in-use fuel requirements. The motor vehicle tailpipe standards include different phase-in schedules that vary by vehicle class, but generally phase-in between model years 2017 to 2021 for light duty vehicles and up to 2025 for heavy duty vehicles. The vehicle emission standards combined with the reduction of gasoline sulfur content, which allows both current and new vehicle emission control systems to function at a higher pollutant removal efficiently, will significantly reduce motor vehicle emissions of NOX, VOCs, direct PM2.5, CO and air toxics. Compared to current vehicle and fuel standards, the non-methane organic gases (NMOG) and NOX, presented as NMOG+NOX, Tier 3 tailpipe standards for light-duty vehicles are estimated to show an approximately 80% reduction from today's fleet average. As both NOX and VOCs contribute to the formation of ground level ozone and secondary PM2.5, the EPA notes that these vehicle emission reductions will have a positive impact on all areas of the nation including Utah County. Additionally, we expect to see associated downward trends of CO, ozone, PM2.5 and PM10 concentrations that will reflect the implementation of these fuel/vehicle emission improvements. Based on these expected reductions in motor vehicle emissions of NOX, along with the monitoring data showing that Utah County is currently attaining the 2008 ozone NAAQS, we conclude that Rule R307-311 will not interfere with attainment of the ozone NAAQS.

The EPA notes that NOX emissions, which contain NO2, are a precursor to the formation of ground level ozone, PM2.5, and PM10. We also note that Utah County was designated as unclassifiable/attainment for the new, more stringent, 2010 1-hour NO2 NAAQS (77 FR 9532, February 17, 2012).

To assess the potential impacts to Utah County's continued attainment of the 2010 1-hour NO2 NAAQS, as that version of the NO2 NAAQS is more constraining, EPA considered NO2 ambient air quality monitoring data for Utah County. The state provided recent NO2 air quality monitoring data in the Rule R307-311 TSD. EPA has excerpted that information from the TSD and presents those data in Table 4 below:

As can be seen in Table 4 above, Utah County continues to demonstrate compliance with 2010 1-hour NO2 NAAQS with values well below the level of the NAAQS. We, therefore, conclude that Rule R307-311 will not interfere with attainment of the 1-hour NO2 NAAQS.

On the basis of the above EPA analyses, we have concluded that using a portion of the Utah County PM10 SIP's PM10 MVEB to offset or compensate for excess on-road mobile sources NOX emissions, on a one-to-one basis and in one direction only, continues to demonstrate attainment of the PM10 NAAQS and is conservative and justifiable. In addition, based on the information in the Rule R307-311 TSD, and as supplemented by information prepared by EPA, we have concluded that with the implementation of the provisions in Rule R307-311 there will not be adverse effects to the CO, PM2.5, 8-hour ozone, and NO2 1-hour NAAQS. These statements are with respect to the implementation of the provisions of Rule R307-311 by MAG when MAG performs a transportation conformity determination for its RTP and/or TIP.

Section 110(l) of the CAA states that a SIP revision cannot be approved if the revision would interfere with any applicable requirement concerning attainment and reasonable further progress towards attainment of a NAAQS or any other applicable requirement of the CAA. In view of the state's rule language for its new Rule R307-311, our analyses presented above in section “V. EPA's Evaluation of the Technical Support Document for R307-311” with respect to PM10, PM2.5, ozone and NO2, and the fact that NOX has less impact on a per ton basis than primary PM10 emissions in Utah County, we have concluded there will be a net benefit on ambient air concentrations of PM10 when excess NOX emissions are offset on a one to one basis. Therefore, implementation of the provisions of Rule R307-311 will allow the continued demonstration of attainment of the PM10 NAAQS in Utah County and is conservative and justifiable. We have also concluded there will be no adverse impact on any other NAAQS or applicable requirement of the CAA. Therefore, our approval of the State's Rule R307-311 is consistent with section 110(l) of the CAA.

The EPA is publishing this rule without prior proposal because the Agency views the Governor of Utah's March 9, 2015 submitted SIP revisions for Utah's Rule R307-311 and the Rule's associated TSD as a noncontroversial amendment and anticipates no adverse comments. However, in the Proposed Rules section of today's Federal Register publication, EPA is publishing a separate document that will serve as the proposal to approve the SIP revision if adverse comments are filed. This rule will be effective July 17, 2015 without further notice unless the Agency receives adverse comments by June 17, 2015. If the EPA receives adverse comments, the EPA will publish a timely withdrawal in the Federal Register informing the public that the rule will not take effect. The EPA will address all public comments in a subsequent final rule based on the proposed rule. The EPA will not institute a second comment period on this action. Any parties interested in commenting must do so at this time. Please note that if the EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, the EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment.

In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of the Utah SIP materials and rules described in the amendments to 40 CFR part 52 set forth below. The EPA has made, and will continue to make, these documents generally available electronically through www.regulations.gov and/or in hard copy at the appropriate EPA office (see the ADDRESSES section of this rule's preamble for more information).

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it 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).

The SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it approves a state rule implementing a Federal standard.

In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the state to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission; to use VCS in place of a SIP submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq).

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by July 17, 2015. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the proposed rules section of today's Federal Register, rather than file an immediate petition for judicial review of this direct final rule, so that EPA can withdraw this direct final rule and address the comment in the proposed rulemaking. This action may not be challenged later in proceedings to enforce its requirements. (See CAA section 307(b)(2).)

40 CFR part 52 is amended to read as follows:

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2012-0963 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before July 17, 2015. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2012-0963, by one of the following methods:

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

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

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

In the Federal Register of February 21, 2014 (79 FR 9870) (FRL-9904-98), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 2F8102) by BASF Corporation, 26 Davis Dr., Research Triangle Park, NC 27709. The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of Trichoderma fertile strain JM41R in or on all food commodities. That document referenced a summary of the petition prepared by the petitioner BASF Corporation, which is available in the docket via http://www.regulations.gov. There were no comments received in response to the notice of filing.

Subsequently, the petitioner provided additional data (i.e., DNA sequence work based on newly published taxonomies) on the identity of the pesticide to EPA. After reviewing these data, EPA concluded that the correct identity of the pesticide was Trichoderma asperelloides strain JM41R and not Trichoderma fertile strain JM41R. In order to give the public an opportunity to comment on this new information, EPA republished its receipt of this tolerance exemption petition filing with an updated and accurate description in the Federal Register of January 28, 2015 (80 FR 4525) (FRL-9921-55) and placed a revised petition from BASF Corporation into the docket. There were no comments received in response to the republished notice of filing.

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

EPA evaluated the available toxicity and exposure data on Trichoderma asperelloides strain JM41R and considered its validity, completeness, and reliability, as well as the relationship of this information to human risk. A full explanation of the data upon which EPA relied and its risk assessment based on that data can be found within the April 20, 2015, document entitled “Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for Trichoderma asperelloides strain JM41R.” This document, as well as other relevant information, is available in the docket for this action as described under ADDRESSES. Based upon its evaluation, EPA concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of Trichoderma asperelloides strain JM41R. Therefore, an exemption from the requirement of a tolerance is established for residues of Trichoderma asperelloides strain JM41R in or on all food commodities when used in accordance with label directions and good agricultural practices.

An analytical method is not required for enforcement purposes for the reasons contained in the April 20, 2015, document entitled “Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for Trichoderma asperelloides strain JM41R” and because EPA is establishing an exemption from the requirement of a tolerance without any numerical limitation.

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

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

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

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

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

Therefore, 40 CFR chapter I is amended as follows:

This document announces that, on May 5, 2015, OMB approved certain information collection requirements contained in the Commission's Report and Order, FCC 14-153, published at 80 FR 1238, January 8, 2015. The OMB Control Number is 3060-1208. The Commission publishes this document as an announcement of the effective date of these information collection requirements.

As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), the FCC is notifying the public that it received OMB approval on May 5, 2015, for the new information collection requirements contained in the Commission's rules at 47 CFR 1.40001(c)(3)(i), 1.140001(c)(3)(iii), and 1.140001(c)(4). Under 5 CFR part 1320, an agency may not conduct or sponsor a collection of information unless it displays a current, valid OMB Control Number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act that does not display a current, valid OMB Control Number. The OMB Control Number is 3060-1208.

The foregoing notice is required by the Paperwork Reduction Act of 1995, Public Law 104-13, October 1, 1995, and 44 U.S.C. 3507.

The total annual reporting burdens and costs for the respondents are as follows:

OMB Control Number: 3060-1208.

OMB Approval Date: May 5, 2015.

OMB Expiration Date: May 31, 2018.

Title: Acceleration of Broadband Deployment by Improving Wireless Facilities Siting Policies.

Form Number: N/A.

Respondents: Individuals or households, business or other for-profit entities, not-for-profit institutions and State, local or Tribal governments.

Number of Respondents and Responses: 1,350 respondents; 3,597 responses.

Estimated Time per Response: .5 hours to 1 hour.

Frequency of Response: Third-party disclosure reporting requirement.

Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this information collection is contained in Sections 1, 2, 4(i), 7, 201, 301, 303, and 309 of the Communications Act of 1934, as amended, and Sections 6003, 6213, and 6409(a) of the Middle Class Tax Relief and Job Creation Act of 2012, Pub. L. 112-96, 126 Stat. 156, 47 U.S.C. 151, 152, 154(i), 157, 201, 301, 303, 309, 1403, 1433, and 1455(a).

Total Annual Burden: 3,535 hours.

Total Annual Cost: None.

Nature and Extent of Confidentiality: There is no need for confidentiality with this collection of information.

Privacy Act Impact Assessment: This information collection may affect individuals or households. However, the information collection consists of third-party disclosures in which the Commission has no direct involvement. Personally identifiable information (PII) is not being collected by, made available to, or made accessible by the Commission. There are no additional impacts under the Privacy Act.

Needs and Uses: The Commission requested OMB approval for new disclosure requirements pertaining to subpart CC of part 1 of the Commission's rules. This subpart was adopted to implement and enforce Section 6409(a) of the Middle Class Tax Relief and Job Creation Act of 2012. Section 6409(a) provides, in part, that “a State or local government may not deny, and shall approve, any eligible facilities request for a modification of an existing wireless tower or base station that does not substantially change the physical dimensions of such tower or base station.” 47 U.S.C. 1455(a)(1). In subpart CC, the Commission adopted definitions of ambiguous terms, procedural requirements, and remedies to provide guidance to all stakeholders on the proper interpretation of the provision and to enforce its requirements, reducing delays in the review process for wireless infrastructure modifications and facilitating the rapid deployment of wireless infrastructure.

The following are the information collection requirements in connection with subpart CC of part 1 of the Commission's rules:

• 47 CFR 1.40001(c)(3)(i)—To toll the 60-day review timeframe on grounds that an application is incomplete, the reviewing State or local government must provide written notice to the applicant within 30 days of receipt of the application, clearly and specifically delineating all missing documents or information. Such delineated information is limited to documents or information meeting the standard under paragraph (c)(1) of Section 1.40001.

• 47 CFR 1.40001(c)(3)(iii)—Following a supplemental submission from the applicant, the State or local government will have 10 days to notify the applicant in writing if the supplemental submission did not provide the information identified in the State or local government's original notice delineating missing information. The timeframe for review is tolled in the case of second or subsequent notices of incompleteness pursuant to the procedures identified in paragraph (c)(3). Second or subsequent notices of incompleteness may not specify missing documents or information that were not delineated in the original notice of incompleteness.

• 47 CFR 1.40001(c)(4)—If a request is deemed granted because of a failure to timely approve or deny the request, the deemed grant does not become effective until the applicant notifies the applicable reviewing authority in writing after the review period has expired (accounting for any tolling) that the application has been deemed granted.

These collections are necessary to effectuate the rule changes that implement and enforce the requirements of Section 6409(a).