On May 26, 2006, the Office of Personnel Management (OPM) published proposed regulations (71 FR 30301) to amend 5 CFR, part 551, subparts A, B, F and G. The changes were proposed to update and harmonize OPM's regulations with the Department of Labor's (DoL) regulations issued under the Fair Labor Standards Act of 1938 (referred to as “FLSA” or “the Act”). In addition, we provided in the proposed regulations a clearer understanding of coverage for executive, administrative, and professional employees by adding definitions and examples.

The 60-day comment period for the proposed regulations ended on July 25, 2006. During the period, OPM received comments from 11 Federal agencies, five labor organizations, and two individuals.

A number of the comments support OPM's adherence to and adoption of DoL's language in our regulations and the increased ease of applying the FLSA to Federal employees. Commenters noted that the added explanatory materials improved clarity and reduced the potential for erroneous FLSA exemption determinations.

Respondents also identified areas of concern and provided specific recommendations to improve the proposed revisions. We addressed those comments and recommendations beginning with general and/or global comments, followed by a section-by-section discussion. We also made minor editorial corrections which do not affect the content of the regulations.

One agency suggested we include a discussion in the preamble regarding OPM's expectations with regard to how the new regulations will impact coverage determinations properly made under the previous regulations.

As indicated in the proposed regulations, with the exception of the adoption of the revised criteria in the salary basis test, these changes update and clarify but do not fundamentally change the regulations in place as applied consistently with controlling case law. Therefore, we do not anticipate changes in the exemption status of the vast majority of Federal employees to whom the current regulations were properly applied.

The proposed regulations eliminated the 80 percent test as a basis for FLSA coverage. One labor organization commented that the 80 percent test should remain in the regulations as it permits all employees who perform significant amounts of non-exempt work to benefit from FLSA protection. An agency noted that a court or arbitrator often focuses on the amount of time an employee spends on exempt and closely related duties in determining if an employee is covered by FLSA regulations. That agency suggested we include a discussion highlighting the elimination of the 80 percent test requirement and emphasizing the potential importance of the amount of time an employee spends performing exempt functions to support an agency's exemption determination.

Controlling case law has made retention of the 80 percent requirement unsupportable. Federal courts have found many employees to be exempt who spent less than 50 percent of their time performing exempt work. See, e.g., Jones v. Virginia Oil Co., 69 Fed. Appx. 633 (4th Cir. 2003) (management was found to be the “primary duty” of an employee who spent 75 to 80 percent of her time on basic line-worker tasks); Murray v. Stuckey's, Inc., 939 F.2d 614 (8th Cir. 1991) (manager met the “primary duty” test despite spending 65 to 90 percent of his time in non-management duties); Glefke v. K.F.C. Take Home Food Co., 1993 WL 521993 (E.D. Mich. 1993) (employee found exempt despite assertion that she spent less than 20 percent of time on managerial duties because “the percentage of time is not determinative of the primary duty question, rather, it is the collective weight of the four factors”); and Stein v. J.C. Penney Co., 557 F. Supp. 398 (W.D. Tenn. 1983) (employee spending 70 to 80 percent of his time on non-managerial work held exempt because the “overall nature of the job” is determinative, not “the precise percentage of time involved in a particular type of work”). See also, Horne v. Crown Central Petroleum, Inc., 775 F.Supp. 189 (D.S.C. 1991); Donovan v. Burger King, 672 F.2d 221 (1st Cir. 1982); Donovan v. Burger King, 675 F.2d 516 (2nd Cir. 1982).

One agency asked that we include a discussion regarding the appropriateness of reviewing the classification of a position in terms of title, series, and grade, if an FLSA review by a third party reveals new information that contradicts the current classification. While a third party review of an FLSA coverage determination may reveal questions regarding the classification of the employee's work, it is inappropriate to apply 5 U.S.C. chapters 51 and 53 requirements to the regulatory process for implementing 5 CFR part 551 for employees under OPM's FLSA jurisdiction, as these statutory requirements have no bearing on FLSA exemption determinations.

One agency recommended we revise the work aid, “How to make exemption status determinations under the Fair Labor Standards Act (FLSA)” to reflect changes made to the regulations. The work aid, now titled “Making an FLSA Exemption Status Determination—A Work Aid” is found on our Web site at http://www.opm.gov/flsa and will be updated once the final rule is issued.

One agency expressed concern that we italicized a term not defined in the regulations. In this final rule, all terms listed in the Definitions section at § 551.104 are italicized in the regulations.

One labor organization suggested that DoL's regulations appear to violate the letter or spirit of the FLSA, and while OPM's interpretation of the FLSA must be generally consistent with DoL's interpretation, OPM need not mirror DoL where doing so would violate the FLSA. We note that the commenter's concern is addressed in § 551.101(c). We also note that DoL's changes have gone through the Administrative Procedure Act (APA) review and comment process and now have the force of law. To the extent that OPM's regulations are consistent with DoL's regulations, OPM does not violate the FLSA; hence, the labor organization's comment is misplaced. We have provided examples to the extent we believe necessary to properly apply the regulations.

One agency recommended we add an explanation that the law does not require OPM's regulations to comply verbatim with DoL's administration of the Act. The agency maintains that doing so will alert Code of Federal Regulations users that while administration of the Act by OPM and DOL is similar in some aspects, marked differences remain. We believe the first sentence in § 551.101(c) addresses the agency's concern regarding marked differences: “OPM's administration of the Act must comply with the terms of the Act but the law does not require OPM's regulations to be identical to the Department of Labor's FLSA regulations.”

One labor organization commented that this section fails to state why and when OPM regulations may diverge from DoL regulations, and that it also fails to clarify that OPM regulations cannot apply FLSA exemptions more broadly than DoL regulations. Citing a Court of Appeals ruling that OPM regulations could not make it more difficult for Federal employees to qualify for overtime than DoL regulations ( AFGE v. OPM, 821 F.2d 761, 771 (D.C. Cir. 1987)), the commenter expressed the concern that OPM regulations can and should be more specific than DoL regulations in narrowly defining exemptions. We refer the commenter to Billings v. U.S., 322 F.3d 1328 (Fed. Cir. 2003), which places the labor organization's concern in the appropriate context. As stated in Billings, “ AFGE stands for the unremarkable proposition that, under the same facts, an employee in federal employment should receive the same overtime compensation as an employee in the private sector. In this case, however, the appellants are not employed under the same facts applicable to the private sector. Appellants as federal employees, are subject to Title 5 suspensions not present in the private sector.” We also note that the Court of Federal Claims in Adams v. U.S., 40 Fed. Cl. 303 (1998) found OPM's regulation to be valid despite the fact it did not contain a salary-basis test and, therefore, was inconsistent with DoL regulations. Rather, the court held that OPM's regulation was a reasonable interpretation of the FLSA within the Federal sector.

We received a number of comments regarding the proposed changes we made to this section. Some respondents had concerns with particular definitions, while others commented on our decision to move terms from this section and place them where the concept is addressed in the regulation.

One agency recommended that in the definitions section, we earmark those definitions that have been removed and addressed as concepts in other sections of the provisions. Like DoL, we have moved these terms and concepts in order to streamline, update, and clarify these complex regulations, as well as reduce unnecessary duplication and redundancies. We provided such information in the proposed rules to alert current users to the change. Therefore, we decline to adopt the recommendation to cross-reference the location of terms in these final regulations.

In addition to the general concerns listed above, we received specific questions relating to the following definitions:

One agency suggested we clarify the definition to make clear that tasks occurring on a regular and recurring basis, even if they do not occur every workweek, meet the definition of the term customarily and regularly. We did not adopt this suggestion because we do not believe it adds to the understanding of the term.

One labor organization expressed the concern that changes in the definition weaken the protections of the FLSA by expanding the executive exemption criteria at § 551.205. They maintain that removing the phrase “day-to-day” from the definition permits employees who only occasionally exercise executive discretion to meet the exemption criteria. These regulations expressly prohibit the interpretation put forward by the labor organization since the definition states that the “frequency must be greater than occasional” and “ * * * includes work normally and recurrently performed every workweek.” We do not believe exemption criteria for executives will be expanded and decline to change the definition as requested.

One agency was concerned that we removed the definition of this term when, in fact, we did not. Due to the extensive discussion regarding the administrative exemption, we placed the term with the administrative exemption criteria at § 551.206. We have included the term in alphabetical order in the definition section at § 551.104 with a cross reference to § 551.206.

One agency suggested we provide additional information regarding when a training facility will qualify as an Educational establishment. Training facilities vary widely within the Federal sector and are found in a number of different settings. These settings range from Department of Defense-operated primary and secondary schools and military technical training schools, to law enforcement training centers and adult training facilities operated by a variety of Federal agencies. Because of this wide variability in facilities, we do not believe further detailed discussion will add materially to a better understanding of the term.

In accordance with information obtained from the Department of the Interior's Office of Insular Affairs, we have added the Commonwealth of the Northern Mariana Islands, a territory under the jurisdiction of the United States, to the list of exclusions from the definition of exempt areas.

One agency commented that the terminology related to who is and who is not covered by the FLSA is confusing. The agency explained that if the term “FLSA exempt” means not covered by the provisions of the Act, then the term “FLSA nonexempt” means FLSA “not-not covered.” The agency recommended we replace the term “FLSA nonexempt” and insert a new term “FLSA covered.” The commenter noted that exempt employees are exempt from the overtime and minimum wage provisions of the Act. We note that exempt employees are covered by other provisions of the Act. We decline to adopt this recommendation since the proposed terminology is inconsistent with that used by the Department of Labor.

One labor organization commented that our definition with respect to performing work involving management policies or operating procedures in relation to broad national goals expressed in statutes or Executive orders is “overboard,” as virtually all Government employees endeavor to comply with broad national goals set by statute or Executive order. Consequently, the labor organization recommended we revise the definition to clarify that administrative work involves compliance only with management's operational policies. We agree with the labor organization's concern that administrative work involves compliance only with management's operational policies rather than compliance with substantive statutes; however, this issue is already addressed in § 551.206(b)(1) which directs the user to consider if an employee “has authority to formulate, affect, interpret, or implement management policies or operating practices.” Therefore, we decline to revise this definition.

Two labor organizations stated that adding the words “interpret,” “implement,” and “operating practices,” to the definition broadens the coverage of the term to be inconsistent with the Act. This definition is consistent with the current DoL definition and does not change the underlying meaning of the regulation; therefore, we decline to revise this definition.

One labor organization suggested changes in the definition are problematic because the proposed definition eliminates the distinction between production and support services. We address this distinction in § 551.206, and we consider its placement there more appropriate than in the definition of management.

One labor organization suggested we amend the definition to clarify a team leader does not become exempt merely by apportioning work among the team members. They recommended we expressly state what the administrative provision indirectly says in describing which leaders qualify for exemption. The labor organization asserts that, just as in the private sector ( see 29 CFR 541.203(c)), team leaders are exempt administrators only if they perform such administration functions as “acquisitions, negotiating real estate transactions or collective bargaining agreements, designing and implementing productivity improvements” or similar work as specified in § 551.206(i). While we understand the labor organization's concern regarding the misreading of apportioning work, we must rely on the reader to understand that selected phrases of a definition must be read within the context of the entirety of the regulations, and the full intent of the definition must be applied. Therefore, we do not find the proposed expanded discussion to be necessary. Further, we do not agree with the commenter's characterization of § 551.206(i). Team leaders who lead major projects and who function as an extension of management for matters of significance to the employer are likely to meet the administrative exemption. Section 551.206(i) must be read in conjunction with § 551.206(b)(2) (i.e., an employee may carry out major assignments in conducting the operations of the organization), which does not limit exemption to leading staff functions.

In accordance with information obtained from the Department of the Interior's Office of Insular Affairs, we have added the Commonwealth of the Northern Mariana Islands, a territory under the jurisdiction of the United States, to the list of nonexempt areas.

One agency recommended we add to this definition the requirement that a duty must occupy at least 25 percent of the employee's time. This definition, for the most part, is carried over from our previous regulation with specific requirements to ensure that users do not focus on a very small percentage of time when it would be highly unlikely that the duty would support the basis for primary duty. The definition is consistent with the discussion of the 80 percent test in the General Comments section of this preamble. Therefore, we decline to adopt this recommendation.

One labor organization viewed the definition of recognized organizational unit as problematic because it suggests even a team leader with little actual supervisory function can be considered the lead of a recognized organizational unit. The labor organization maintained the definition should clearly state that a recognized organizational unit does not consist of temporary units whose composition or purpose is constantly in flux. We believe the definition fully addresses these concerns. Again, we must rely on the user to understand that recognized organizational unit must be read in conjunction with the other criteria under the executive exemption at § 551.205 (i.e., a leader will not meet the executive exemption if that employee does not exercise the full range of management and work control responsibilities required to meet the requirements of this section).

One agency recommended we further clarify the definition by supplementing it with additional work examples and illustrations. The agency believes the revised definition of “trainee” at paragraphs (1) through (5) implies application to certain employment categories/classifications operative in Federal service. We believe the definition makes clear that a student officially appointed to a Government position is not a trainee for purposes of the FLSA. The definition of trainee for purposes of the FLSA is materially different from the meaning of “trainee” for many purposes of title 5, U.S.C., and similar human resources statutes.

One labor organization suggested that, assuming removal of the 80/20 test is warranted, OPM should delete as superfluous the § 551.104 definitions relating to “worktime.” They also suggested we remove the word “worktime” from § 551.101(a), as that paragraph contains no substantive content, but merely refers to the FLSA's delineation of “administrative procedures by which covered worktime must be compensated.” The labor organization maintains that OPM should replace the word “worktime” with the statutory phrase to refer to FLSA delineation of procedures for compensating “hours of work.” The labor organization is of the opinion that such a change would harmonize with DoL's regulations. We made no substantive change in the definition of worktime itself because these regulations are intended to address FLSA coverage issues and not hours of work. Definitions relating to worktime are not used in defining hours of work but are used solely in determining FLSA exemption status; therefore, we decline to make this change.

We received several requests to move the sections on specific professional exemptions from the end of subpart B and place them directly following the professional exemption criteria in this section. Based on these comments, we have reordered the sections, and in this final rule, those sections formerly numbered §§ 551.214 through 551.216 in the proposed rule, containing information relating to specific professional exemptions, have been placed directly behind § 551.207 Professional exemption criteria and renumbered as §§ 551.208 through 551.210. The remaining sections have been renumbered accordingly.

One labor organization suggested this section (as well as § 551.202) would be strengthened if it emphasized reasonable doubt regarding exemption status should be resolved in favor of nonexemption. This concern is addressed by § 551.202(d) which states, “If there is a reasonable doubt as to whether an employee meets the criteria for exemption, the employee will be designated FLSA nonexempt.”

We received several comments regarding revised paragraph (e), which clarifies that the designation of an employee as FLSA exempt or nonexempt ultimately rests on the duties actually performed by the employee. The occupational or organizational title alone is not sufficient for an FLSA exemption status determination.

Three agencies commented on the requirement that the designation of an employee as FLSA exempt or nonexempt ultimately rests on the duties actually performed by the employee. We fully agree that the coverage determination must be based on the actual work performed by the employee. The protective nature and purpose of the FLSA requires agencies to assure such accuracy on a continuing basis. The same responsibility holds true for existing and newly established positions. While we appreciate the recommendations received to clarify this section, we have concluded that our statement at § 551.202(e) will make the requirements clear to those who apply these regulations; we do not believe any additional guidance is required.

One agency disagreed with our statement at § 551.202(e) that “established position descriptions and titles may assist in making initial FLSA exemption determinations” and saw no need for further review if a position description accurately describes the duties performed by the employee. Additionally, the agency questioned how exemption status is determined for newly established unencumbered positions and questioned whether proposed duties should be used to make an FLSA coverage determination. Finally, the agency recommended adding to the end of this section, “on a regular and recurring basis over a period of more than 30 consecutive calendar days.” We understand the commenter's concern about making an FLSA coverage determination on newly established positions. In such cases, the determination must be based on the description of work because no employee is actually performing the work. However, once an employee is placed in the position, the agency is responsible for ensuring that the FLSA designation is accurate and remains accurate, based upon the actual work performed by that employee. Thus, we decline to insert the proposed phrase.

One agency found the second sentence of § 551.202(f) difficult to understand. We did not propose changes to this section. The purpose of this section is to recognize that employees may perform a combination of exempt duties and may qualify for exemption. While one of the exemption criteria may not be met in its entirety, the work may meet another which serves as the basis for the exemption determination. To respond to the request for clarification and to further harmonize with DoL's regulations at 29 CFR 541.708, we have amended § 551.202(f) to explain that an employee whose primary duty involves a combination of exempt administrative and exempt executive work may qualify for exemption; i.e., work that is exempt under one section of this part will not defeat the exemption under any other section.

One labor organization had concerns with the first sentence of § 551.202(h) in the proposed rule which read: “Although it is normally feasible and more convenient to identify the exemption category, this is not essential.” They stated that while an employee's primary duty may involve two categories which are intermingled and difficult to segregate, an employer always bears the burden of establishing the basis for an exempt classification. The labor organization maintained that OPM should adhere to the principle that employers must identify any and all exemption categories used to exempt a particular job. We did not propose a change to this section. The first sentence of § 551.202(h) accurately covers, for example, the professional employee who may also meet the executive exemption. In this case it would not be necessary to identify which one of the two served as the specific basis for the exemption determination because both exemptions would apply. However, to clarify this concept, we have revised the first sentence to read, “Although it is normally feasible and more convenient to identify a single exemption category, this is not always appropriate.” We have also added a sentence at the end of § 551.202(h) to require that, “The agency is responsible for showing and documenting that the work as a whole clearly meets one or more of the exemption criteria.”

A number of commenters opposed our adoption of DoL's $23,660 minimum salary level test as a nonexemption threshold. One labor organization requested we provide a reasoned explanation for the change in our position after previously rejecting a salary test as ill-suited for use with the Government's classification system. This labor organization, along with another labor organization, stated that OPM is not bound by law to adopt DoL's approach to this issue, since Federal salaries are not impacted by the large retail sector that DoL must consider in making rules, and therefore, few Federal employees would benefit from this salary level test. OPM regulations governing the Federal sector must be as consistent as practicable with DoL's regulations governing the private sector.

Many positions previously covered by the unitary general schedule (GS) system are now covered by alternative pay systems. The GS system to which our previous regulations were linked no longer covers large numbers of Federal employees under OPM's FLSA jurisdiction. Further, it is contemplated that additional groups of Federal employees may be removed from coverage under the GS system in the future. Therefore, direct linkage to GS grade levels is of diminishing utility to the FLSA exemption determination process. Furthermore, concerns that lower graded nonsupervisory employees who meet the minimum salary level threshold will become exempt are misplaced. As noted in § 551.204(a), nonsupervisory clerical and lower-graded technical employees will remain nonexempt because they will not meet any of the exemption criteria.

When the FLSA was extended to the Federal sector in 1974, GS-5 and GS-6 supervisory positions exceeded the minimum salary level test. In December 1997, OPM issued subsequent regulations ( see 62 FR 67238, December 23, 1997). At that time, all supervisory GS-5 and GS-6 positions still received annual salaries substantially higher than the minimum salary level test. These positions, and prevailing rate first-level supervisory positions, were also affected by the 80 percent test. These conditions made use of the minimum salary level test in 1974 and 1997 moot.

As discussed in the General Comments section of this preamble, we are no longer using the 80 percent test based on controlling case law. Also, DoL raised the minimum salary test to the point where some nonappropriated fund instrumentality positions might meet the executive exemption test, but would fail to meet the minimum salary threshold of $23,660. In adopting the minimum salary test, these lower-salaried employees will continue to have their nonexempt status protected, thereby assuring a result consistent with DoL's regulations. The fact that a small number of positions are affected does not diminish our responsibility to ensure these employees receive any and all protections afforded by the Act and its implementing regulations. Nevertheless, we view this minimum salary threshold as transitory and believe it will likely become obsolete given the small number of employees potentially affected at the present time, and the likely continued rise in Federal salary rates.

One labor organization expressed concern regarding OPM's use of the annual figure that DoL adopted for the private sector without reference to salary data from the Federal sector. One agency suggested that rather than show a specific rate of basic pay due to changes in cost of living and impacts of inflation, we should refer users to a Web site for current thresholds. OPM regulations governing the Federal sector must be as consistent as practicable with DoL's regulations governing the private sector. Therefore, we decline to make any changes.

One agency suggested OPM use the term “total adjusted salary” or “adjusted basic pay” in place of “rate of basic pay” to clarify the rate of pay being used for comparison purposes. We have not adopted the suggested terms and will continue to use “rate of basic pay” which is defined in § 551.203(b) to include locality pay and certain similar supplements.

The same agency also recommended we provide an explanation at § 551.203(a)(3) as to why only a “ * * * professional in the practice of law or medicine as prescribed in paragraphs (c) and (d) of § 551.208,” is not covered by the salary-based nonexemption. We changed the language to be consistent with DoL's longstanding exclusion from the salary test of employees who hold a valid license or certificate permitting the practice of law or medicine, or any of their branches, and who are actually engaged in the practice thereof. This exclusion also applies to employees who hold the requisite degree for the general practice of medicine and who are engaged in an internship or residency program pursuant to the practice of a profession. See 29 CFR 541.600. We also note that such positions in the Federal Government receive compensation well in excess of the minimum salary level test.

One labor organization suggested we remove the first word “certain” in § 551.204(a), as it is unnecessary and confuses the meaning of the section. We disagree. Removal of the word “certain” from this section would overly broaden the category of nonexempt nonsupervisory white-collar employees. For this reason, we have not adopted the suggestion.

One labor organization commented that the removal from the regulations of the statement that, “A supervisory employee in the Federal Wage System or in other comparable wage systems is exempt only if the employee is an executive employee....,” expands the exemption, may even implicitly suggest that all supervisory employees should be exempt, and is contrary to the FLSA. The labor organization contends these regulations should include a passage regarding the nonexemption of FWS supervisory employees. We find that the inclusion of the suggested language would be superfluous. As stated in § 551.202(a), an employee is presumed to be FLSA nonexempt unless the employing agency correctly determines that the employee clearly meets one or more of the exemption criteria. Therefore, agencies are obligated to fully apply the executive exemption criteria to all supervisory positions to determine if they are exempt.

One agency suggested we amend § 551.204(a)(2) to include language to address pay banding systems. The agency recommended we add a particular pay band level that, in their agency, is equivalent to the GS-9 level. This assumes most agencies will band grades in the same manner as the commenting agency. As agencies generally establish their own pay banding schemes, our regulations permit each agency to determine which of its bands is equivalent to a particular level. For this reason, we have not adopted the suggestion.

One agency noted that there is no mention of work-planning and assignment responsibilities, and only a small number of personnel authorities are mentioned. The agency suggested that in the final regulations, we provide language to: (1) Clarify the importance of work-planning and assignment responsibilities in meeting the exemption criteria; and (2) clarify whether the few personnel activities mentioned in § 551.205 are more critical to meeting the exemption criteria than are the others mentioned in the definition of the term “management” in § 551.104. The commenter noted that a floor is established by the specifics in § 551.205(a)(2). We note this floor is expansive and links back directly to the term “management” as noted in § 551.205(a) and defined in § 551.104, and is not limited to hiring, firing, advancement, and promotion, but also pertains to any other change of employee status. Therefore, while some employees covered by the executive exemption may not perform each and every activity listed under “management,” there is an expectation that they will perform the functions listed under § 551.205(a)(2). We decline to make the suggested change.

One labor organization voiced concern that we removed the requirement for executives to regularly exercise discretion and independent judgment, or spend 80 percent of their time on “supervisory and closely related work.” The labor organization requested we clarify that executives necessarily exercise the type of “discretion and independent judgment” that the role explicitly requires. As recognized by the labor organization in their comments, we have included in the definition of primary duty the requirement to exercise discretion and independent judgment, and the definition of management illustrates how this judgment is applied. This issue is adequately addressed in § 551.104 of this regulation; therefore, we have not made the requested change.

One agency commented that in § 551.205(a)(1), there may be situations where a supervisor, as a regular and recurring part of his or her job, may supervise only one employee. They further commented that the General Schedule Supervisory Guide (GSSG) does not require a minimum number of subordinates for a position to be classified as supervisory. As noted previously in this preamble, the definition of “supervisor” for purposes of chapters 51 and 53 of title 5, U.S. Code, is separate and distinct from the definition for purposes of applying the FLSA.

One labor organization stated that the “scope of direction” element in § 551.205(a)(1) is too wide, and further commented that permitting exemption for employees who direct a mere two other persons far exceeds the purpose of the executive exemption. The labor organization contended that the proposed regulations more closely describe a group leader or working supervisor rather than an executive, and that a true executive position is one with a broader scope of control covering at least five full-time employees. We must reject the labor organization's request to increase the number of employees directed, given that this language is substantively the same as the existing regulations and consistent with DoL's regulatory language.

Regarding the term “particular weight” in § 551.205(b), one agency indicated it has a number of locations where supervisors direct the work of different groups of employees each day, because operations not only occur 24 hours per day, but also in several different stations within one location. Additionally, performance ratings may be created by a group of supervisors who together may have supervised each of the rated employees, but who may have not supervised the same group of employees on each workday and shift worked. The agency requested additional information regarding the impact on whether or not an employee can be an exempt executive if she or he supervises a variety of individuals over the course of the workweek and recommends personnel actions on the basis of consulting with other supervisors, all of whom also supervise the same group of employees on different days or shifts. We believe this issue is adequately addressed in § 551.104 under the term “recognized organizational unit” in paragraph (3). In addition, the general human resources practice of designating an official supervisor of record, with specific delegations of responsibility, facilitates the application of these FLSA requirements.

We received a number of questions and concerns from agencies and labor organizations regarding the interpretation and application of the administrative exemption criteria. Changes were made to this section largely to harmonize with DoL changes in the description of administrative work and to add examples of specific types of work performed in the Federal Government.

One labor organization requested we insert the express comparison between staff service or support work as distinguished from production or line work. The labor organization maintains that we could avoid any confusion by reinserting language from the definition of Management or general business functions or supporting service in the prior regulations. We do not agree with the labor organization's recommendation to reinsert language from the definition in the prior regulations. However, to further clarify the distinction between staff and line work, we revised § 551.206 by inserting “, as distinguished from production functions,” after the word “operations” in the first sentence.

One agency suggested we add language to define the minimum level of immediate guidelines and supervision needed to constitute discretion and independent judgment. We believe the examples in § 551.206(b) provide adequate context for applying the concept of discretion and independent judgment.

Two labor organizations had concerns with the concept of employees having the authority to formulate, affect, interpret, or implement management policies or operating practices. One of the labor organizations expressed concern that the application of § 551.206(b)(1) will exempt employees who should not be exempt, contending that many nonsupervisory white-collar employees perform work that requires them to implement or interpret management policies and operating practices with respect to mission-critical activities, yet their work is indisputably of a routine nature. One labor organization viewed the definition as being overly expansive. We believe the factors provided in § 551.206(b) provide adequate context for applying the concept of discretion and independent judgment. In addition, § 551.206(e) makes clear that work of a routine nature will not meet the administrative exemption. The terminology we adopted is consistent with DoL's regulations ( see 29 CFR 541.202(b)). We believe that when read and applied in the context of the regulations as a whole, the language is not overly broad. Therefore, we decline to modify our language.

One agency suggested we provide an example of an exempt Federal administrative employee who would be involved in performing exempt administrative work for the employing agency's customers. We believe that § 551.206(h) already provides an adequate description of this type of exempt work. Therefore, we decline to accept this suggestion.

Two agencies suggested we clarify what constitutes “matters of significance” by adding language to clarify the scope and effect of the work and adding a definition of the term. We believe we have explained the intent of the Act by the examples provided throughout § 551.206. In this regard, we have aligned with DoL's approach by describing relevant factors to consider in making the appropriate exemption determination.

One labor organization asserted that in trying to address duties performed by employees who support workers on the production side in § 551.206(h), we omitted the requisite language distinguishing administrative staff who provide operational support from nonexempt employees working on the production end. They contend that, as proposed, the paragraph creates confusion by referring to employees who support line managers without offering examples of nonexempt line or production duties. We agree with the comment and have added clarification at the end of § 551.206(h) by inserting examples of investigative work that may either be exempt or nonexempt depending on whether it is performed as a line or staff function.

One labor organization expressed concern that the proposed regulations at § 551.206(h) may weaken the line versus staff dichotomy and by doing so, may upset decades of court precedent regarding this feature of the administrative exemption. We do not agree with the labor organization's concern, as our illustrations are consistent with case law. We reference Piscione v. Ernst & Young , 171 F.3d 527 (7th Cir. 1999) for discussion of when advisory and program development work that affects management policy and internal operations of client organizations is administratively exempt.

One agency commented that § 551.206 should provide information regarding OPM's expectations about the coverage or exemption of those performing a supporting service under the revised regulations. The concept of administratively exempt work can be found at § 551.206(h).

Several commenters remarked that the guidance provided on team leaders in § 551.206(i) is unclear. One agency commented that where project examples are provided, the decision as to whether or not the team leader was exempt seemed to be based on the types of projects led, thereby necessitating a decision on the relative worth of the projects, rather than on the team leader's responsibilities. One labor organization expressed concern that the examples provided are not found in DoL's regulations on team leaders, thereby making it difficult to ascertain precisely how or when these activities could be considered major projects. The labor organization suggested that, to avoid imposing an overly broad definition of “team leader,” these examples should be removed or the provision should make clear that reviews or investigations do not constitute examples of major projects unless they involve the exercise of discretion and independent judgment. Another labor organization shared the concern that § 551.206(i) could drastically broaden the executive exemption, in that paragraph (i) appears to describe a working supervisor more closely than an administrator. The labor organization suggested removal of this paragraph from the regulations. To clarify the intent of § 551.206(i), we have added an example of a lead auditor who would meet the administrative exemption.

One labor organization commented that the definition of management/program analysts in § 551.206(l) seems to suggest that any employee who engages in the study of the operations of an organization or a program has a primary duty that is directly related to the management or general business operations of the employer. They suggest that OPM clarify that an employee must have as his or her primary duty the study of such operations, as well as the recommending of changes to operations. They further suggest OPM clarify that employees in this position do not necessarily meet the requirement that they exercise discretion and independent judgment on matters of significance. We do not believe these revisions are necessary, as § 551.206 makes clear what should be considered in determining an employee's primary duty. In addition, § 551.206(l) is to be applied within the entirety of the administrative exemption criteria, which are applicable only when the employee's work entails the exercise of discretion and independent judgment on matters of significance.

One agency recommended that OPM clarify what constitutes ordinary inspection work at § 551.206(n) and explain what the statement, “They have some leeway in the performance of their work but only within closely prescribed limits” means. We decline to add language, as we believe § 551.206(n) is sufficiently clear as written.

As stated earlier in this preamble, we reordered subpart B of the final regulations. Consequently, § 551.208 in the final regulations corresponds to § 551.214 in the proposed regulations.

One labor organization expressed numerous concerns regarding our treatment of learned professionals. They suggest that the proposed regulations neglect to emphasize that, with rare exceptions, learned professionals must have advanced degrees to succeed in their field. This labor organization maintained that in explaining the impact of the word “customarily,” the proposed regulations permit exemption of individuals who perform substantially the same work as degreed employees, without making clear how rarely employees attain such positions without advanced degrees. These proposed regulations are consistent with existing 5 CFR 551.207(a)(1). The work requires the application of knowledge customarily and characteristically acquired through education or training that meets the requirements for a bachelor's or higher degree. However, in an effort to address the labor organization's concerns, we have modified the language at § 551.208(a)(3) to emphasize the infrequency of employees attaining professional positions without advanced degrees.

The same labor organization expressed concern regarding § 551.208(b), maintaining it provides management with the ability to seek new learned professions whenever a school creates a new advanced degree. They requested this section be removed. Discussion of the expansion of professions in § 551.208(b) is consistent with 29 CFR 541.301(f); therefore, we decline to eliminate the section.

This labor organization also commented that the description of the accounting profession provided at § 551.208(e) is ambiguous and uses equivocating language. Our description is consistent with 29 CFR 541.301(e)(5); therefore, we decline to change the regulations.

One agency and two labor organizations raised concerns regarding misapplication of the engineering profession at § 551.208(f). One labor organization stated that the portion of § 551.208(f) concerning engineering technicians should be entirely removed. We have revised the language to clarify that engineering technicians infrequently perform exempt work.

One individual commented that, in the private sector, registered nurses paid on an hourly basis are nonexempt and therefore entitled to overtime pay under FLSA. The commenter suggests if OPM considers registered nurses exempt based on meeting the duties requirement without considering the salary test, then Federal Registered nurses are at a disadvantage. In this regard, the individual objected to § 551.208(j) which reads, “Registered nurses who are registered by the appropriate State examining board generally meet the duties requirements for the learned professional exemption.” We believe these concerns are misplaced. Section 551.208(j) must be read in conjunction with the salary-based nonexemption at § 551.203. Registered nurses paid on an hourly basis will not meet the annual pay basis requirements of § 551.203(a) because the exemption only applies to employees paid on an annual pay basis. Therefore, such employees will be nonexempt.

As stated earlier in this preamble, we reordered subpart B of the final regulations. Accordingly, § 551.210 in the final regulations corresponds to § 551.216 in the proposed regulations.

One agency recommended renaming this section “Information Technology employees” to remain consistent with how Federal classification standards refer to these positions. Section 13(a)(17) of the Act specifically addresses computer occupations, as do DoL's implementing regulations in 29 CFR part 541, subpart E. As noted previously in this preamble, Federal position classification and job grading laws and regulations do not control FLSA definitions. Therefore, we decline to accept this recommendation.

One agency and one labor organization found the intermingling of the computer exemption under sections 13(a)(1) and 13(a)(17) of the Act confusing. We believe that § 551.210 is sufficiently clear as written. Further, our description is consistent with 29 CFR 541.400; therefore, we decline to change the regulations.

One labor organization raised concerns regarding proposed § 551.210(d), where we state that certain employees meeting exemption under section 13(a)(17) of the Act may also have executive and administrative duties which qualify the employees for exemption under executive and administrative exemption rules as well. The labor organization maintained that it is unclear how these same employees could also have executive or administrative work as their primary duty, unless their computer functions completely overlap with executive or administrative work. They further maintained that if such overlapping of duties occurred, the executive and administrative rules would add nothing to the designation of these employees as FLSA exempt or nonexempt. As discussed in connection with § 551.202(h), agencies are responsible for showing and documenting that an employee's work as a whole clearly meets one or more of the exemption criteria. We decline to change this language.

As stated earlier, we reordered subpart B of the final regulations. As a result, § 551.211 in the final regulations corresponds to § 551.208 in the proposed regulations. We also renamed the section to more appropriately reflect the intent of § 551.211.

Several labor organizations raised the same concerns regarding the 30-day test that OPM addressed in the General Comments section of the 1997 regulations ( see 62 FR 67238). We responded to this issue at that time, and our response remains the same. The 30-day test is well-established and has been unchanged in OPM regulation since January 1988. At that time, OPM made clear the extent of an agency's responsibilities regarding an employee who must temporarily perform work or duties that are not consistent with the primary or grade-controlling duty of his or her official position description.

Two agencies expressed concern with, and questioned the intent of, this section. One agency suggested that if a temporary assignment is expected to last beyond 30 days, the agency should, as good management practice, determine the exemption status of the employee at the beginning of the temporary assignment. This agency maintained that it is not practical or fair for an agency to pay an employee overtime under FLSA rules during the first 30 days of an assignment, while knowing that an exempt assignment will last beyond the 30 days, and then have to require the employee to repay the overtime. The other agency raised similar concerns. The intent of § 551.211(d) is to deal with situations where management is unclear regarding the duration of an assignment. We decline to amend this portion of the regulations.

As stated earlier in this preamble, we reordered subpart B of the final regulations. Consequently, § 551.213 in the final regulations corresponds to § 551.210 in the proposed regulations.

At the request of an agency, we have amended § 551.213(a) to include the statutory provision under which employees are exempted from FLSA coverage by receiving availability pay.

The same agency commented that we should include a note in § 551.213(b) that positions formerly classified as pilots at the U.S. Customs Service are now identified at the U.S. Customs and Border Protection (CBP) as CBP Air Interdiction Agents, GS 1881. As the statutory requirements of 5 U.S.C. chapter 51 are not controlling in applying the FLSA, we decline to amend the regulations to cite specific position titles. We have changed the agency name in the regulations from U.S. Customs Service to U.S. Customs and Border Protection.

As stated earlier, we reordered subpart B of the final regulations. Accordingly, § 551.214 in the final regulations corresponds to § 551.211 in the proposed regulations.

One agency suggested that the regulations should cite the statutory and regulatory provisions regarding customs officers covered by 19 U.S.C. 267 rather than attempt to list all the covered titles. We agree and have amended the regulations to delete reference to specific titles.

As stated earlier, we reordered subpart B of the final regulations. Consequently, § 551.215 in the final regulations corresponds to § 551.212 in the proposed regulations.

We received numerous comments from a labor organization questioning and speculating on why we added this section. This labor organization expressed concern that the firefighter definition in 5 CFR 550.1302 will be altered by issuance of this regulation. They maintain the existing firefighter definition is adequate, and this rule may make interpretation of section 7(k) of the Act in the Federal sector more complex. In addition to this labor organization's comments, two agencies raised concerns regarding the effect of these regulations on wildland firefighters. These comments indicate that further clarification is required.

This section pertains to two distinct topics: fire protection activities and coverage under the section 7(k) provisions of the Act. The revised regulations continue OPM's longstanding policy that the section 7(k) provisions are not automatically applied to all employees who perform fire protection activities. OPM rules provide that the section 7(k) provisions are applied only to employees receiving certain types of premium pay associated with extended tours of duty. For example, section 7(k) is applicable to a fire protection employee only if he or she receives annual premium pay under 5 U.S.C. 5545(c) (usually standby duty pay under (c)(1)) or firefighter's compensation under 5 U.S.C. 5545b. These premium payments apply to firefighters who have extended tours, usually including 24-hour shifts.

Wildland firefighters are not covered by the regulatory provisions for section 7(k) employees at § 551.541. This matter was clarified in the regulations in 1976, and wildland firefighters who do not receive the specific types of premium payments under §§ 551.501(a)(1) and (5) will continue to be covered by section 7(a) of the Act under these regulations. We have modified §§ 551.215(a) and 551.541(a) in the final regulations to better align it with this section of the regulation.

One labor organization provided a number of comments in response to the establishment of this section. The labor organization commented that OPM's inclusion of fire inspections among the list of fire protection activities at § 551.215(b) is confusing, suggesting it may lead to the erroneous conclusion that employees who solely perform fire inspections are engaged in fire protection activities under section 7(k). We note that the proper interpretation of § 551.215(b) is predicated upon reading it within the entirety of § 551.215. The labor organization's concern is best addressed by reading § 551.215(b) in conjunction with § 551.215(d)(2). Nevertheless, to clarify this section, we have changed § 551.215(b) by adding “by trained firefighters eligible for reassignment to fire control and suppression or prevention duties” in the clause dealing with inspections.

The labor organization commented that OPM is obligated at § 551.215(b) to comply with DoL's interpretation of the application of section 7(k) to emergency medical service (EMS) personnel as set forth in 29 CFR 553.215(b). The section cited in the labor organization's comment addresses ambulance and rescue service employees of public agencies subject to the Act prior to the 1974 amendments. We therefore assume this comment is misplaced and intended to reference 29 CFR 553.215(a). Our proposed and final regulations are consistent with the pertinent DoL regulations at 29 CFR 553.215(a); therefore, we decline to change this section.

This labor organization requested modification of § 551.215(c)(2) and (3) to include all the necessary requirements, for example, that the temporary employee be hired by a fire department, that he or she be trained in fire suppression, and that he or she actually perform fire suppression activities. This labor organization also suggested that OPM remove § 551.215(c)(4) entirely, maintaining the section neither complies with the FLSA nor conforms with DoL's interpretation of the FLSA. The labor organization referred to 29 U.S.C. 203(y), stating DoL's regulations define employees in fire protection activities. They further relied on AFGE v. OPM , 821 F.2d 761, 770 (D.C. Cir. 1987) in asserting we must change our regulations “in a manner consistent with the Secretary of Labor's implementation of the Fair Labor Standards Act.”

We agree that OPM's regulations should be consistent with the statutory definition of “employee in fire protection activities” in section 3(y) of the FLSA (29 U.S.C. 203(y)). We have modified proposed paragraphs (b), (c), and (d) of § 551.215 accordingly.

As stated earlier, we reordered subpart B of the final regulations. As a result, § 551.216 in the final regulations corresponds to § 551.213 in the proposed regulations.

One labor organization and one agency objected to what they construed as applying section 7(k) to correctional officers and requested that the regulations explicitly state that such employees will not be subject to section 7(k) of the Act. This section of the regulations pertains to two distinct topics: law enforcement activities and coverage under section 7(k) provisions of the Act. The revised regulations continue OPM's longstanding policy that the section 7(k) provisions are not automatically applied to all employees who perform law enforcement activities. OPM rules provide that the section 7(k) provisions are applied to employees receiving certain types of premium pay. For example, section 7(k) is applicable to a law enforcement employee if he or she receives annual premium pay under 5 U.S.C. 5545(c)(1) for regularly scheduled standby duty, or under 5 U.S.C. 5545(c)(2) for substantial amounts of irregular, unscheduled overtime work which cannot be controlled administratively.

One agency objected to the differences between the definition of law enforcement activities for FLSA purposes, and the statutory definition of “law enforcement officer” (LEO) for retirement purposes in 5 U.S.C. chapters 83 and 84. The agency's objections emphasized that such a distinction undermines the long-standing determination that LEO retirement coverage extends to all employees who work within its correctional facilities. As discussed earlier, just as it is inappropriate to apply 5 U.S.C. chapters 51 and 53 definitions to terms used in the FLSA, the same holds true for the statutory definition of LEO in 5 U.S.C. chapters 83 and 84; that definition is not controlling in defining “law enforcement officers” for purposes of the FLSA.

One individual stated the partial listing of positions contained in §§ 551.216(c)(2) through (6) is misleading and will result in officers being inappropriately characterized as not qualifying. We note the examples provided are not exhaustive. They are meant to supplement, not take the place of, § 551.216(b). The use of these examples is consistent with DoL's regulations at 29 CFR 553.211(c). Therefore, we decline to adopt the suggestion to remove paragraphs (c)(2) through (6).

While not included in the proposed regulations, § 551.541 has been modified to align the language with new §§ 551.215(a) and 551.216(a), which now make clear that not all fire protection and law enforcement employees, respectively, are covered by section 7(k) of the Act. To avoid confusion, we have deleted from § 551.541(a) the language referring to employees not covered by section 7(k) so that § 551.541 deals solely with section 7(k) employees. Additionally, § 551.541(b) has been revised for continuity with § 551.541(a).

In the proposed regulations we added paragraph (c) to § 551.601 in order to define hazardous Federal fire protective activities for individuals under 18 years of age. No comments were received in response to this addition. We are adopting the proposed language as final.

In this subpart of the proposed regulations, we clarified in § 551.702(c) that the claimant is responsible for retaining documentation to establish when a claim is received; in § 551.705(b) we corrected the reference from paragraph (b) to paragraph (c); and in § 551.707(a) we clarified that OPM may grant a request from a claimant to withdraw his or her claim. No comments were received in response to these revisions; therefore, we are adopting the proposed language as final.

The Office of Management and Budget has reviewed this rule in accordance with E.O. 12866.

OPM has determined that these regulations will not have a significant economic impact on a substantial number of small entities because they apply only to Federal agencies and employees.

This regulatory action will not impose any additional reporting or recordkeeping requirements under the Paperwork Reduction Act.

These regulations are consistent with the requirements of E.O. 12988. The regulations clearly specify the effects on existing Federal law or regulation; provides clear legal standards; has no retroactive effects; specifies procedures for administrative and court actions; defines key terms; and is drafted clearly.

OPM has determined these regulations will not have Federalism implications because they apply only to Federal agencies and employees. The regulations will not have financial or other effects on States, the relationship between the Federal Government and the States, or the distribution of power and responsibilities among the various levels of government.

These regulations will not result in the expenditure by State, local, or tribal governments of more than $100 million annually. Thus, no written assessment of unfunded mandates is required.

The regulations in “Subpart—Fruits and Vegetables” (7 CFR 319.56 through 319.56-47, referred to below as the regulations) prohibit or restrict the importation of fruits and vegetables into the United States from certain parts of the world to prevent the introduction and dissemination of plant pests that are new to or not widely distributed within the United States.

On June 5, 2007, we published in the Federal Register (72 FR 30979-30984, Docket No. APHIS 2007-0061) a proposal  1 to amend the regulations to allow the importation into the continental United States of fresh blueberries from South Africa and Uruguay under certain conditions. As a condition of entry, we proposed that the blueberries would have to undergo cold treatment and would have to be accompanied by a phytosanitary certificate issued by the national plant protection organization (NPPO) of the exporting country. In addition, we proposed to allow the use of cold treatment for blueberries imported into the United States from Argentina.

We solicited comments concerning our proposal for 45 days ending July 20, 2007. We received six comments by that date. They were from blueberry distributors, a commercial fumigation company, and a blueberry industry group. Four of the commenters supported the proposed rule. One commenter did not address the proposed rule.

One commenter objected to the proposed rule. The commenter expressed concern that we did not consult with domestic blueberry producers prior to issuing the proposal and that the studies conducted in support of the rule were conducted hastily. Because the proposed rule and its supporting risk analysis were focused on identifying and managing the risks associated with importing blueberries from Uruguay and South Africa, we did not find it necessary to consult with the domestic blueberry industry during the preparation of those documents. The risk assessment and risk management documents were drafted using the same approach and in the same timeframe as the other risk analyses the Animal and Plant Health Inspection Service (APHIS) prepares or reviews. In addition, we offered the public, including domestic blueberry producers, the opportunity to comment on the proposed rule following its publication in the Federal Register .

The commenter further stated that information in the proposed rule regarding domestic production is out of date and incorrect, and suggested that we refer to information released by the North American Blueberry Council (NABC). The data we used in the proposed rule's economic analysis was taken from the National Agricultural Statistics Service (NASS) and the Economic Research Service (ERS), with the ERS report cited being the most current data available (May 2007). The data we received incorporates information from a variety of sources, including the NABC.

Finally, the commenter expressed concern regarding the lack of market access for U.S.-grown blueberries into Uruguay and South Korea. This is not germane to the proposal.

Therefore, for the reasons given in the proposed rule and in this document, we are adopting the proposed rule as a final rule, with the changes discussed in this document.

This is a substantive rule that relieves restrictions and, pursuant to the provisions of 5 U.S.C. 553, may be made effective less than 30 days after publication in the Federal Register .

Immediate implementation of this rule is necessary to provide relief to those persons who are adversely affected by restrictions we no longer find warranted. Therefore, the Administrator of the Animal and Plant Health Inspection Service has determined that this rule should be effective upon publication in the Federal Register .

This rule has been reviewed under Executive Order 12866. The rule has been determined to be not significant for the purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget.

We are allowing the importation into the continental United States of fresh blueberries from South Africa and Uruguay under certain conditions. As a condition of entry, the blueberries will have to undergo cold treatment and will have to be accompanied by a phytosanitary certificate issued by the NPPO of the exporting country. This action allows for the importation of blueberries from South Africa and Uruguay into the continental United States while continuing to provide protection against the introduction of quarantine pests. In addition, we are allowing the use of cold treatment for blueberries imported into the United States from Argentina. This action will provide an alternative to the currently approved methyl bromide treatment.

The Regulatory Flexibility Act (RFA) requires that agencies consider the economic impact of their rules on small businesses, organizations, and governmental jurisdictions. In accordance with section 604 of the RFA, we have prepared a final regulatory flexibility analysis describing the expected impact of the changes in this rule on small entities. During the comment period for our proposed rule, we received one comment pertaining to the initial regulatory flexibility analysis presented in that document. The commenter stated that information in the proposed rule regarding domestic blueberry production is out of date and incorrect and suggested that we refer to information released by NABC. The data we used in the proposed rule's economic analysis was from NASS and ERS, with the ERS report cited being the most current data available (May 2007). The data we received from NASS incorporates information from a variety of sources, including NABC.

The United States is the largest producer of blueberries, supplying more than half the world's production (55 percent). Canada follows with 28 percent of world supplies and Poland comes third with 10 percent of the world's blueberry fruit production.

Michigan, Maine, and New Jersey are the leading States in U.S. blueberry production. Combined, these three States produce more than half of all U.S. blueberries (table 1). Nine States account for 98 percent of U.S. production. Fresh blueberries require harvesting by hand, whereas blueberries destined for processing can be machine-harvested. The cost of farm labor is considerably higher in the United States than in many other countries.

In 2005, the United States produced 135,021 metric tons of highbush blueberries destined for the fresh market, valued at $381 million. In the United States, highbush blueberries are harvested from April to early October with the majority of the blueberries picked from mid-June to mid-August.

Between 1995 and 2005, total U.S. blueberry consumption increased by 47 percent, from 13 ounces to 20 ounces per person. Most of the increase has been in the fresh market with a doubling in fresh consumption, from 4.3 ounces per person in 1995 to 8.7 ounces in 2005.

Table 2 shows U.S. imports and exports of fresh blueberries for the past 3 years. The United States is a net importer, and our major foreign supplier of fresh blueberries (by value) is Canada. Annual U.S. imports of fresh blueberries averaged 29,469 metric tons between 2004 and 2006.

Argentina has supplied about 3 percent of the U.S. imports of fresh blueberries, or 880 metric tons, over the last 3 years. In 2006, Argentina reported 4,000 acres of land devoted to blueberry production, a 35 percent increase since 2003.

The Uruguayan Government Statistics office indicates that Uruguay started producing blueberries in 2003, with 65 metric tons harvested that year. In the following 3 years, Uruguay produced 80, 120, and 200 metric tons, respectively. For 2007 through 2009, crop volumes of around 500, 1,200, and 2,000 metric tons are forecast.

The Government of Uruguay has indicated its intention to export between 200 and 1,200 metric tons of fresh blueberries annually for the next 3 years starting in 2007, with 200 metric tons shipped annually to the continental United States (an amount that exceeds Uruguay's total exports of fresh blueberries in recent years). 3 Even if this export target were met, imports from Uruguay will represent less than 1 percent of U.S. imports of fresh blueberries in 2006.

Uruguay's main export season for fresh blueberries is between November and April. During this season, the supply of fresh blueberries by U.S. producers is limited. Fresh blueberries are generally harvested in the United States by early May through the beginning of September. U.S. domestic shipments of fresh blueberries reach their highest volume between late June and mid-August.

APHIS does not have data on South African production of blueberry fruits ( Vaccinium spp.). Foreign Agricultural Service statistics indicate that South Africa exported an annual average of 75 metric tons of Vaccinium spp. between 2000 and 2004. Specifically, in 2000 the Republic of South Africa exported 3 metric tons, then in the following 4 years, 90, 83, 86, and 109 metric tons, respectively. In sum, the quantities of fresh blueberry expected to be imported into the United States from Uruguay and the Republic of South Africa are small, representing less than 1 percent of U.S. imports and less than one-tenth of 1 percent of the United States' domestic supply (production plus imports minus exports). Moreover, blueberry production in these two countries takes place during our winter months; their blueberry shipments to the United States would largely compete with blueberry imports from other countries. We do not expect the changes we are making to have a significant economic impact on U.S. entities. U.S. entities that could be affected by the changes are domestic producers of fresh blueberries and wholesalers that import fresh blueberries. Businesses producing fresh blueberries are classified in the North American Industry Classification System (NAICS) within the category of Other Vegetable (except Potato) and Melon Farming (NAICS code 111219). The Small Business Administration's small-entity definition for these producers is annual receipts of not more than $750,000. Firms that will import fresh blueberry fruits from Uruguay and the Republic of South Africa are defined as small entities if they have 100 or fewer employees (NAICS code 424480, Fresh Fruit and Vegetable Merchant Wholesalers). 4

In general, firms engaged in production or importation of agricultural commodities are predominantly small. We believe that most if not all of the businesses affected by this rule would be small.

We do not know the exact number of U.S. producers of fresh blueberries. According to the 2002 Census of Agriculture for the States where blueberries are produced, there were at least 6,428 farms growing blueberries in 52,000 acres of land (table 1). The majority of these farms (84 percent) are located in nine States. We do not know the percentage of blueberry farms that produce blueberries for the fresh market. Also, we do not know their size, but in general, such entities are predominantly small. The United States Census does not report sales receipts by farm or any other unit. The average farm size in these nine States is 15 acres, whereas the average farm size in the remainder of States that grow blueberries is 2.5 acres. However, as stated above, we do not expect this rulemaking to have a significant economic impact on U.S. entities.

Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action will not have a significant economic impact on a substantial number of small entities.

We are allowing fresh blueberries to be imported into the United States from South Africa and Uruguay. State and local laws and regulations regarding imported fresh blueberries will be preempted while the fruit is in foreign commerce. Fresh fruits are generally imported for immediate distribution and sale to the consuming public, and remain in foreign commerce until sold to the ultimate consumer. The question of when foreign commerce ceases in other cases must be addressed on a case-by-case basis. No retroactive effect will be given to this rule, and this rule will not require administrative proceedings before parties may file suit in court challenging this rule.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ), the information collection or recordkeeping requirements included in this rule have been approved by the Office of Management and Budget (OMB) under OMB control number 0579-0321.

The Animal and Plant Health Inspection Service is committed to compliance with the E-Government Act to promote the use of the Internet and other information technologies, to provide increased opportunities for citizen access to Government information and services, and for other purposes. For information pertinent to E-Government Act compliance related to this rule, please contact Mrs. Celeste Sickles, APHIS' Information Collection Coordinator, at (301) 734-7477.

The USDA Rural Development Utilities Programs (the Agency) improves the quality of life in rural America by providing investment capital, in the form of loans and grants, for the deployment of rural telecommunications infrastructure. Financial assistance is provided to rural utilities; municipalities; commercial corporations; limited liability companies; public utility districts; Indian tribes; and cooperative, nonprofit, limited-dividend, or mutual associations. In order to achieve the goal of increasing economic opportunity in rural America, the Agency finances infrastructure that enables access to a seamless, nation-wide telecommunications network. With access to the same advanced telecommunications networks of its urban counterparts, especially broadband networks designed to accommodate distance learning, telework and telemedicine, rural America will see improving educational opportunities, health care, economies, safety and security, and ultimately higher employment. Of particular concern to the Agency are communities where broadband service is not available and where population densities are such that the cost of deployment to them is high and build-out of infrastructure is unlikely. The Agency is committed to ensuring rural communities will have access to affordable, reliable, advanced communications services, comparable to those available throughout the rest of the United States, to provide a healthy, safe and prosperous place to live and work. The Community Connect Grant Program was started as a Pilot Program with the Fiscal Year 2002 budget and has been funded ever since through the appropriations process. After administering the program as a pilot program for two years, the Agency proposed rules for the program, and on July 28, 2004, the current rules were published, and the program was formally implemented. Since then more than 670 requests for grant funds totaling over $410 million were requested through Fiscal Year 2006. Of those requests, 129 were granted for $57 million to bring broadband service to 129 communities in 26 states and Puerto Rico. While the Agency is proud of the results achieved in the Community Connect Grant Program thus far, it believes that the overall effectiveness of the program can be improved by modifying the existing rules. Through these changes, the Agency is increasing eligibility criteria to include communities that clearly meet the intent of the program. Specifically, this rule will: (1) Add the Rand McNally Atlas as a community locator; (2) change the income measure for eligibility from a national comparison to a state comparison; and (3) clarify the items that are eligible to be considered as operating expenses.

This is to confirm the effective date of September 17, 2007, for the direct final rule 7 CFR 1739, Community Connect Grant Program, published in the Federal Register on August 3, 2007.

Background

On December 17, 1992, the United States, Canada, and Mexico entered into the North American Free-Trade Agreement (NAFTA). The stated objectives of the NAFTA include the elimination of barriers to trade in, and the facilitation of the cross-border movement of, goods and services between the territories of the countries. The provisions of the NAFTA were adopted by the United States with the enactment of the North American Free Trade Agreement Implementation Act (the “Act”, 19 U.S.C. 3301-3473). On September 6, 1995, U.S. Customs and Border Protection (CBP) published Treasury Decision (T.D.) 95-68 (North American Free Trade Agreement) in the Federal Register (60 FR 46333), adopting amendments to the regulations in title 19 of the Code of Federal Regulations (CFR) in order to implement customs-related aspects of the NAFTA. The final rule went into effect on October 1, 1995.

Pursuant to sections 403(1) and 411 of the Homeland Security Act of 2002, Pub. L. 107-296 (the “HSA”), the United States Customs Service and certain of its functions were transferred from the Department of the Treasury to the Department of Homeland Security effective March 1, 2003. In addition, pursuant to section 1502 of the HSA, the “Customs Service” was renamed as the “Bureau of Customs and Border Protection.” Subsequently, on April 23, 2007, a Notice was published in the Federal Register (72 FR 20131) to inform the public that the name of the Bureau of Customs and Border Protection had been changed by the Department of Homeland Security to “U.S. Customs and Border Protection (CBP)”, effective March 31, 2007.

On August 23, 2006, a Notice of Proposed Rulemaking was published in the Federal Register (71 FR 49391; the NPRM) by CBP that proposed to amend the regulations to clarify the requirements for claiming the merchandise processing fee (MPF) under the NAFTA and to effect several technical changes, as set forth below.

As a means of recouping administrative expenses for the processing of imported shipments, CBP charges a MPF, as provided for in 19 U.S.C. 58c. However, under 19 U.S.C. 58c(b)(10)(B), for goods qualifying under the rules of origin set out in 19 U.S.C. 3332, the fee may not be charged with respect to goods that qualify to be marked as goods of Canada or of Mexico (pursuant to Annex 311 of the NAFTA). In order to make a claim for NAFTA duty preference, an importer must make a declaration. The same declaration is also used for purposes of claiming the MPF exemption. That is, the importer must place the appropriate special program indicator (e.g., “CA” for goods of Canada and “MX” for goods of Mexico) opposite the good on the entry form, or in the appropriate location in an electronic filing.

The NPRM addressed situations in which an importer of an originating good does not have a duty preference incentive to make the required NAFTA declaration upon entry because the Normal Trade Relations rate of duty on the good is free (i.e., the good is unconditionally duty free). Consistent with existing law and practice, the NPRM proposed to amend 19 CFR 181.21(a) to clarify that in order to claim the MPF exemption for unconditionally free goods from a NAFTA country, an importer of an originating good must place the appropriate special program indicator opposite the good on the entry form even if the importer is not actually claiming NAFTA preference for duty purposes.

Section 181.22(b) of title 19, CFR (19 CFR 181.22(b)), requires an importer who claims preferential tariff treatment on a good under 19 CFR 181.21 to provide, at the request of the port director, a copy of each Certificate of Origin pertaining to the good which is in the possession of the importer. However, certain importations are exempted from this requirement under 19 CFR 181.22(d). One of these exemptions, set forth in § 181.22(d)(1)(iii), is for a commercial importation of a good whose value does not exceed $2,500, as long as a signed statement is attached to the invoice or other documents accompanying the shipment.

In the NPRM, CBP proposed to amend the regulations to clarify that the $2,500 value refers to the total value of a shipment and not to the value of the individual goods in a shipment. In this regard, CBP specifically proposed to amend 19 CFR 181.22(d)(1)(iii) in order to clarify that a Certificate of Origin is not required for a commercial importation consisting of originating goods, the total value of which does not exceed $2,500, if the required statement is attached.

In the NPRM, CBP also proposed to make several other technical corrections to the regulations. In CBP Dec. 05-32, an Interim Rule published in the Federal Register (70 FR 58009) on October 5, 2005, CBP redesignated 19 CFR 12.132 as § 102.25. However, there is a reference to § 12.132 in § 181.21(a). Accordingly, CBP proposed to make a minor conforming amendment to update this reference. In addition, because CBP Dec. 05-32 removed the declaration requirement referenced in §§ 12.130(c) and 12.132, CBP proposed to remove the entries for these sections in the list of OMB control numbers in § 178.2. CBP also proposed to amend an incorrect citation to 19 CFR 181.72(a)(2)(iii) in 19 CFR 181.74(a). The correct citation is to § 181.72(a)(3)(iii). In addition, CBP proposed to amend the address in 19 CFR 181.74(e) for providing notification when the Canadian or Mexican customs administrations intend to conduct a NAFTA verification visit in the United States in order to determine whether a good imported into the United States qualifies as an originating good. Since the publication of the NPRM on August 23, 2006, some divisions, functions, and personnel from the Office of Field Operations were transferred by the Commissioner of CBP into the Office of International Trade pursuant to the authority under section 402 of the Safe Port Act (Pub. L. 109-347) (October 13, 2006). The correct address is: “U.S. Customs and Border Protection, Office of International Trade, Commercial Targeting and Enforcement, 1300 Pennsylvania Ave. NW., Washington, DC 20229.” CBP also proposed to amend the National Commodity Specialist Division (NCSD) address in 19 CFR 181.93(a) for purposes of submitting advance ruling requests under the NAFTA. The correct address is: “National Commodity Specialist Division, U.S. Customs and Border Protection, One Penn Plaza, 10th Floor, New York, NY 10119.” This address is also corrected in the list of public reading rooms in 19 CFR 103.1. In addition, CBP is expanding the declaration and other documentation on a claim for preferential treatment in § 181.21 to include electronic versions of such documents in CBP's continuing effort to modernize its procedures under the authority granted by Customs Modernization provisions in the North American Free Trade Agreement Implementation Act (commonly referred to as the “Customs Mod Act”), Pub. L. 103-182, 107 Stat. 2057, 2170 (December 8, 1993).

Comments were solicited on the Notice of Proposed Rulemaking. The comment period closed on October 23, 2006.

One comment was received in response to the solicitation and a description of the comment received and CBP's analysis are set forth below.

The commenter, a Canadian manufacturer, stated that changing the MPF requirements would only increase the costs associated with importing goods into the United States and result in delays during importation. The commenter further noted that additional documentary requirements would increase administrative costs for CBP as well as for importers and brokers, and would ultimately result in less money being recouped. In addition, the commenter suggested that fees should be based strictly on the country of origin as declared and that routine audits and requests for information should be relied upon to monitor importers that do not follow the guidelines.

CBP is not changing the requirements for claiming the MPF exemption. Rather, consistent with existing law and practice, CBP is merely clarifying that an importer is subject to the same declaration requirement that is established for claiming NAFTA duty preference in order to claim the exemption of the MPF for goods that are eligible for preferential duty treatment under the NAFTA. As a clarification of existing law and practice, CBP believes that the amended regulation will serve to facilitate entry by providing certainty under the stated circumstances and will not result in either increased costs or delays during importation. With respect to the commenter's suggestion that the MPF should be based strictly on the country of origin of imported merchandise, it is CBP's position that this approach is not consistent with existing statutory law and is outside the scope of this rulemaking.

No comments were received regarding the other amendments proposed in the NPRM.

After review of the comment and further consideration, CBP has decided to adopt the proposed rule published on August 23, 2006, without substantive changes, but with the additional modifications set forth below.

The final regulations incorporate non-substantive amendments to §§ 181.21, 181.22, 181.74, and 181.93 of the CFR to reflect the nomenclature changes effected by the transfer of CBP to the Department of Homeland Security and the subsequent change of name in the Federal Register notice of April 23, 2007. As discussed above, the final regulation also reflects the reorganization of CBP by the Safe Port Act with the creation of the new Office of International Trade by updating the address and new office in 19 CFR 181.74(e). In addition, the language of § 181.21(a) has been edited to replace “shall” with “must.” In an effort to reflect the modernization of procedures under the Customs Mod Act, § 181.21(a) has also been edited by replacing the reference to “written declaration” with reference to “formal declaration” and a reference to “electronic submissions” has been added to the second sentence.

This rule is not considered to be a significant regulatory action under Executive Order 12866. Accordingly, a regulatory assessment is not required.

It is certified, pursuant to the provisions of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ), that the regulatory amendments set forth in this final rule will not have a significant economic impact on a substantial number of small entities. The rule merely clarifies that, consistent with existing law and CBP practice, an importer is subject to the same declaration requirement that is established for claiming NAFTA duty preference in order to claim the exemption of the MPF for goods that are eligible for preferential duty treatment under the NAFTA. CBP is also clarifying, consistent with current CBP practice, that a Certificate of Origin is not required for a commercial importation consisting of originating goods, the total value of which does not exceed $2,500, if the required statement is attached. Lastly, this document remedies two incorrect addresses and an incorrect Code of Federal Regulations citation, and incorporates non-substantive amendments to certain sections in the regulations to reflect the nomenclature changes effected by the transfer of CBP to the Department of Homeland Security and the reorganization of certain offices in CBP by the Safe Port Act as well as certain other minor editorial changes.

Because the changes with possible paperwork implications set forth in this document are merely clarifications of existing requirements, there is no need to amend the paperwork burden for the number previously approved by OMB for part 181 of 19 CFR. The clearance number for part 181 is 1651-0098.

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

The Nutrition Labeling and Education Act of 1990 (the 1990 amendments) (Pub. L. 101-535) amended the Federal Food, Drug, and Cosmetic Act (the act) in a number of important respects. One aspect of the 1990 amendments was that they clarified FDA's authority to regulate health claims on food labels and in food labeling.

In 1993, FDA issued a regulation to implement the health claim provisions of the 1990 amendments entitled “Food Labeling: General Requirements for Health Claims for Food” (58 FR 2478, January 6, 1993), which established a process for petitioning the agency to authorize health claims about substance-disease relationships and set out the types of information that a health claim petition must include (21 CFR 101.70). This regulation became effective on May 8, 1993.

The final rule that established § 101.80 (21 CFR 101.80) (61 FR 43433, August 23, 1996) (the 1996 final rule), relating sugar alcohols to the nonpromotion of dental caries, completed the first rulemaking that FDA conducted in response to a health claim petition (Docket No. 1995P-0003). Section 101.80 (the dental caries health claim) was subsequently amended, to expand the substances which are the subject of the claim, to include noncariogenic carbohydrate sweeteners other than sugar alcohols (67 FR 71461, December 2, 2002) (the 2002 amendment). Section 101.80(a) describes the role of fermentable carbohydrates, (i.e., most dietary sugars and starches), in the development of dental caries. The fermentation of these carbohydrates by microorganisms produces organic acids on the surface of teeth, which contribute to the development of dental caries through erosion of tooth enamel. Section 101.80(b) explains that some carbohydrate sweeteners, such as sugar alcohols, are relatively noncariogenic because they are fermented by oral microorganisms more slowly than are fermentable carbohydrates and consequently, the rate of acid production is lower than that from fermentable carbohydrates. Noncariogenic carbohydrate sweeteners, when used in place of fermentable sugars, are useful in that they do not promote dental caries as do the sugars they replace. Section 101.80(c) describes the specific requirements of the dental caries health claim, including the requirement that the food bearing the claim be “sugar free” (§ 101.80(c)(2)(iii)(A)). Section 101.80(c)(2)(ii) also lists 11 noncariogenic carbohydrate sweeteners (xylitol, sorbitol, mannitol, maltitol, isomalt, lactitol, hydrogenated starch hydrolysates, hydrogenated glucose syrups, erythritol, D-tagatose, and sucralose) that are eligible for the claim. Section 101.80(c)(2)(iii)(C) further states that, “When carbohydrates other than those listed in paragraph (c)(2)(ii) of this section are present in the food, the food shall not lower plaque pH below 5.7 by bacterial fermentation either during consumption or up to 30 minutes after consumption, as measured by the indwelling plaque pH test found in ‘Identification of Low Caries Risk Dietary Components,’ * * *.”

FDA noted in the 1996 final rule that it would consider adding other noncariogenic carbohydrate sweeteners in the list of sweeteners eligible for the health claim based on a petition to amend the regulation that would show how the substance conforms to the requirements of §§ 101.14(b) (21 CFR 101.14(b)) and 101.80 and that provides evidence that the additional noncariogenic carbohydrate sweetener will not lower dental plaque pH below 5.7 (61 FR 43433 at 43442). Section 101.80 was first amended in 1997 to list the sugar alcohol erythritol as an additional noncariogenic carbohydrate sweetener eligible for the claim (62 FR 63653, December 2, 1997). The petition to list erythritol in § 101.80 (Docket No. 1997P-0206) presented scientific data from a rodent cariogenicity study and from a human in vivo indwelling plaque pH test of erythritol. The agency was satisfied that this evidence was consistent with the results of the studies that investigated the cariogenic potential of the substances previously listed in § 101.80(c)(2)(ii)(A) and that erythritol met the requirements of § 101.14(b). Therefore, erythritol was added to the list of sugar alcohols eligible as a noncariogenic carbohydrate sweetener. Section 101.80 was again amended in the 2002 amendment to add D-tagatose, a non-fermentable sugar, to the list of substances eligible for the health claim. This action was based upon clinical evidence that ingestion of D-tagatose would not lower plaque pH below 5.7 as measured by the indwelling plaque pH method. Because D-tagatose is a sugar, not a sugar alcohol, the 2002 amendment also changed the title of the regulation from “sugar alcohols” to “noncariogenic carbohydrate sweeteners.” The most recent amendment of § 101.80 was to list sucralose, a non-nutritive sweetener, as an eligible noncariogenic sweetener (71 FR 15559, March 29, 2006).

On August 31, 2006, FDA received a health claim petition (Ref. 1) from Hyman, Phelps & McNamara, P.C., submitted on behalf of Cargill, Inc. (petitioner), under section 403(r)(4) of the act (21 U.S.C. 343(r)(4)). The petition requested that FDA amend § 101.80 to authorize a noncariogenic dental health claim for isomaltulose. FDA notified the petitioner on December 8, 2006, that the initial review of the petition had been completed and that the petition had been filed for further action in accordance with section 403(r)(4) of the act. If the agency does not act, by either denying the petition or issuing a proposed regulation to authorize the health claim, within 90 days of the date of filing for further action, the petition is deemed to be denied unless an extension is mutually agreed upon by the agency and the petitioner (section 403(r)(4)(A)(i) of the act and 21 CFR 101.70(j)(3)(iii)). On March 5, 2007, FDA and the petitioner mutually agreed to extend the deadline for the agency's decision on the petition until September 5, 2007. The petitioner requested that FDA consider exercise of its authority under section 403(r)(7) of the act to make the amendment to § 101.80 effective upon publication.

The petitioner identified the substance, which is the subject of the petitioned health claim, to be isomaltulose. Isomaltulose (CAS Reg. No. 13718-94-0) (6-O-α-D-glucopyranosyl-D-fructose) is a disaccharide sugar. The petitioner identified the intended food use of isomaltulose as a nutritive sweetener. A 2005 generally recognized as safe (GRAS) notification to FDA (Ref. 2) identified use of isomaltulose as a nutritive sweetener in a variety of foods to have been determined to be GRAS for food use. For the purpose of a health claim, the term “substance” has been defined as “* * * a specific food or component of food * * *” (§ 101.14(a)(2)). An ingredient added to a food as a sweetener is a component of food. As such, FDA concludes that isomaltulose is a “substance” as defined in § 101.14(a)(2) for the purpose of food labeling, which characterizes the relationship of any substance to a disease or health-related condition.

Dental caries continues to affect a large segment of the U.S. population, notwithstanding its decline in recent years (Ref. 3). The U.S. Department of Health and Human Services' Healthy People 2010 Objectives recognizes dental caries as the single most common chronic disease during childhood, and states that 30 percent of adults have untreated dental decay (Ref. 4). Based on these facts, FDA concludes that, as required in § 101.14(b)(1), dental caries is a disease for which the general U.S. population is at risk.

When a health claim involves consumption of a substance at other than decreased dietary levels, the substance that is the subject of the health claim must contribute taste, aroma, or nutritive value, or any other technical effect listed in § 170.3(o) (21 CFR 170.3(o)) to the food, and must retain that attribute when consumed at the levels that are necessary to justify a claim (§ 101.14(b)(3)(i)). The petitioner stated that the intended use of isomaltulose in food is as a nutritive sweetener. Isomaltulose contributes taste (sweetness), nutritive value (source of calories), and a technical effect (nutritive sweetener) listed in § 170.3(o)(21) to the food and retains these attributes when consumed at levels that are necessary to justify a claim. Thus, the agency concludes that the preliminary requirement of § 101.14(b)(3)(i) is satisfied.

Section 101.14(b)(3)(ii) requires that for a substance to be eligible for a health claim, it must be a food or a food ingredient or a component of a food ingredient whose use at the levels necessary to justify a claim has been demonstrated by the proponent of a claim, to FDA's satisfaction, to be safe and lawful under the applicable food safety provisions of the act. FDA evaluates whether the substance is “safe and lawful” under the applicable food safety provisions of the act. For conventional foods, this evaluation involves considering whether the ingredient that is the source of the substance is GRAS, approved as a food additive, or authorized by a prior sanction issued by FDA (see § 101.70(f)).

The petitioner asserts that there is general recognition of safety, based upon scientific procedures, for the use of isomaltulose as a nutritive sweetener in food. FDA previously received a notice on November 1, 2005, informing FDA that SÜDZUCKER AG, Mannheim/Ochsenfurt, had determined through scientific procedures that use of isomaltulose as a nutritive sweetener in a variety of foods is GRAS (the 2005 GRAS notification). FDA issued a letter on March 20, 2006 (Ref. 2), in response to this notice stating that the agency had no questions at the time regarding SÜDZUCKER's conclusion that isomaltulose is GRAS under the intended conditions of use. The intended conditions of use for isomaltulose stated in the 2005 GRAS notification include use as a nutritive sweetener in the following food categories: Baked goods and baking mixes (§ 170.3(n)(1)); beverages (§ 170.3(n)(2) and (n)(3)); cereal-based products (§ 170.3(n)(4)); chewing gum (§ 170.3(n)(6)); confectionery and frostings (§ 170.3(n)(9)); frozen dairy desserts and mixes (§ 170.3(n)(20)); fruit and water ices (§ 170.3(n)(21)); gelatins, desserts, and puddings, etc. (§ 170.3(n)(22)); jams, jellies, and spreads (§ 170.3(n)(28)); milk products (§ 170.3(n)(31)); nuts and peanut spreads (§ 170.3(n)(32)); processed fruit and fruit juices or vegetable juices (§ 170.3(n)(35)) and (n)(36)); snack foods (§ 170.3(n)(37)); sugar substitutes (§ 170.3(n)(42)); and sweet sauces, toppings, and syrups (§ 170.3(n)(43)). Other categories include nutritive formulas at 5 to 20 percent, energy-reduced foods at 5 to 40 percent, and meal replacements/slimming foods at 5 to 20 percent. Furthermore, FDA is not aware of any scientific evidence that isomaltulose, under the intended conditions of use, would be harmful. The agency has not made its own determination regarding the GRAS status of isomaltulose, however, and notes that authorization of a health claim for a substance should not be interpreted as affirmation that the use of the substance is GRAS. FDA concludes that the use of isomaltulose in food as a nutritive sweetener at levels necessary to justify the claim and in accordance with the 2005 GRAS notification demonstrates to FDA's satisfaction that such use is safe and lawful under applicable food safety provisions of the act. Therefore, FDA concludes that the preliminary requirements in § 101.14(b)(3)(ii) are satisfied.

As recognized in § 101.80, certain carbohydrate sweeteners are relatively noncariogenic compared to fermentable carbohydrates such as starch and most sugars. The relationship between noncariogenic sweeteners and dental caries involves slower fermentation by oral bacteria than that of the dietary sugars they replace. Noncariogenic sweeteners do not promote the development of dental caries because the amount and rate of organic acids resulting from their metabolism by oral bacteria is sufficiently less than that of the fermentable carbohydrates, and they do not cause the loss of minerals from tooth enamel. (§ 101.80(b)) The agency noted in the preamble to the 1996 final rule that it would take action to add additional sugar alcohols to § 101.80 when presented, in part, with evidence that the additional sugar alcohols would not lower plaque pH (i.e., raise plaque acidity) below 5.7 (61 FR 43433 at 43442). FDA has subsequently amended § 101.80 on three occasions to list additional noncariogenic sweeteners in the regulation. The three added noncariogenic sweeteners include a sugar alcohol (erythritol), a sugar (D-tagatose), and a non-nutritive sweetener (sucralose). Although the noncariogenic sweeteners that were initially the subject of the health claim were all sugar alcohols, FDA has amended § 101.80 to list additional noncariogenic sweeteners that are not sugar alcohols. When doing so, FDA also changed the title of the health claim from “Dietary Sugar Alcohols and Dental Caries” to “Dietary Noncariogenic Carbohydrate Sweeteners and Dental Caries.”

Isomaltulose, the subject of the current petition, is a sugar. As is the case with the noncariogenic sweeteners now listed in the dental caries health claim, the potential dental health benefit from isomaltulose derives from its lower fermentability relative to most sugars used as food ingredients. Consequently, the criteria that FDA used to evaluate the other noncariogenic sweeteners in the existing dental caries health claim can be applied to assess whether isomaltulose also qualifies for the health claim.

The recognized role of sucrose in the etiology of dental caries is related to the ability of sucrose to be metabolized by oral bacteria into extracellular polymers that adhere firmly to the tooth surfaces (i.e., dental plaque), and at the same time to form acids that can demineralize tooth enamel (Ref. 5). FDA initially proposed to authorize a health claim relating noncariogenic carbohydrate sweeteners and nonpromotion of dental caries (60 FR 37507, July 20, 1995), based on scientific evidence from studies evaluating changes in human dental plaque pH, plaque acid production, decalcification or remineralization of tooth enamel, and the incidence of dental caries. FDA limited its review to these types of studies because previous reviews by the Federal Government and other authorities had focused on these areas, and the majority of research efforts have also focused on these areas (60 FR 37507 at 37523). FDA concluded that human studies showing sugar alcohols to be associated with reduced rate of acid production in dental plaque relative to sucrose and, in some studies, a reduced incidence of dental caries, were evidence for the association of sugar alcohols and a reduced risk of developing dental caries (60 FR 37507 at 37523). In the 1996 final rule, FDA noted that it would take action to add other sweeteners to the list of substances eligible for this health claim when presented with a petition that included, in part, evidence that the substance would not lower plaque pH below 5.7 (61 FR 43433 at 43442). FDA did not specify a specific method to be used in measuring plaque pH for considering the addition of other sweeteners to the list of eligible substances for this health claim. However, in order for a food that contains both noncariogenic sweeteners and fermentable carbohydrates to qualify for this health claim, § 101.80(c)(2)(iii)(C) specifies that an indwelling pH electrode method of measuring dental plaque pH is the procedure that the agency will use to verify that a food bearing the health claim does not result in a lowering of dental plaque pH below 5.7. The current petition included a report (Ref. 1, Appendix B) from an assay of the cariogenic potential of isomaltulose which used the indwelling pH electrode method of measuring dental plaque pH specified in § 101.80(c)(2)(iii)(C). This is the same type of evidence FDA considered previously in its decisions to amend § 101.80 to list D-tagatose (67 FR 71461) and sucralose (71 FR 15559).

The petition included a report (Ref. 1, Appendix B) of an in vivo assay of the cariogenic potential of isomaltulose. This assay was conducted following the protocol described in “Identification of Low Caries Risk Dietary Components,” by T. Imfield, vol. 11, Monographs in Oral Science , 1983, which is incorporated by reference in the dental caries health claim (§ 101.80(c)(2)(iii)(C)). This protocol provides for the continuous telemetric recording of plaque pH in vivo . The test was conducted for Cerestar R & D Center, Vilvoorde, Belgium, by the University of Zurich, Dental Institute, Clinic of Preventive Dentistry, Periodontology and Cariology, Bioelectric Unit.

The plaque pH telemetry assays were performed with six test subjects in good general health. All test subjects had previously participated in similar studies and their response to positive control procedures was known. Each subject had a miniaturized glass pH-electrode implanted in a dental prosthesis. Once the plaque pH telemetric prosthesis was inserted, it remained in place throughout the test period. Test subjects refrained from all oral hygiene practices, except for water rinses, to allow a 3 to 7 day undisturbed growth of interdental plaque to accumulate over the tips of the pH electrodes.

Baseline plaque pH was measured over a 15 minute period following a 3 minute period of chewing paraffin. Test subjects then rinsed for 2 minutes with 15 milliliters (mL) of a 10 percent aqueous solution of isomaltulose; or alternatively sucking a 1.5 gram (g) tablet of pressed isomaltulose. Plaque pH response to isomaltulose was recorded for 30 minutes following isomaltulose exposure. The paraffin chew/rinse sequence was then repeated using a 10 percent sucrose rinse instead of isomaltulose. The sucrose rinse serves as a positive control to demonstrate the accurate functioning of the pH telemetric equipment and of plaque metabolism.

The study report commented that baseline plaque pH values measured following paraffin chewing coincide with those found in earlier tests with the same test subjects. The study report also commented that the observed decrease of plaque pH subsequent to the sucrose rinse (lowest pH value range was 4.40 to 4.90) demonstrates the accurate functioning of the pH telemetric equipment and of plaque metabolism on the telemetric prosthesis. The lowest interdental plaque pH recorded among the six test subjects during the 30 minutes following the isomaltulose rinse ranged from 6.00 to 6.35 (6.19 ± 0.12, mean ± standard deviation, n=6). The lowest interdental plaque pH recorded among the six test subjects during the 30 minutes following the isomaltulose tablet ranged from 5.80 to 6.65 (6.38 ± 0.39, mean ± standard deviation, n=4). The study report concluded that no critical decrease (i.e., below pH 5.7) in the interdental plaque pH due to bacterial fermentation of isomaltulose occurred following either the rinsing with 15 mL of a 10 percent solution of isomaltulose nor the sucking of a 1.5 g tablet of pressed isomaltulose. Although this report of an in vivo dental plaque pH test of isomaltulose constitutes a limited body of scientific evidence on the cariogenic potential of isomaltulose, FDA is satisfied that this report, in conjunction with the information previously considered by the agency on the etiology of dental caries and the effects of slowly fermentable carbohydrates, are sufficient to enable the agency to evaluate whether isomaltulose should be added to the list of substances eligible for the dental caries health claim.

FDA previously concluded that there was significant scientific agreement among qualified experts to support the relationship between certain noncariogenic carbohydrate sweeteners (e.g., some sugar alcohols, D-tagatose, and sucralose) and the nonpromotion of dental caries. The principal evidence that substantiates this relationship is in vivo data on the effects of noncariogenic carbohydrate sweeteners on human dental plaque pH (§ 101.80(b)). The current petition based its assertion that isomaltulose is noncariogenic on evidence from an indwelling telemetric plaque pH assay of the cariogenic potential of isomaltulose. As discussed in section III of this document, the plaque pH assay demonstrated that isomaltulose did not result in decreases in plaque pH below the critical level of pH 5.7, when introduced as either an aqueous solution or as a tablet, and therefore, would be considered to not promote demineralization of dental enamel. The results of the isomaltulose plaque pH assay are consistent with the evidence relied upon by the agency when adding other noncariogenic sweeteners to the list of sweeteners eligible for this health claim. Therefore, based on the totality of publicly available evidence pertaining to the cariogenic potential of isomaltulose and to the relationship between dental plaque pH and dental caries, FDA concludes that there is significant scientific agreement that isomaltulose does not promote dental caries. Accordingly, FDA is amending § 101.80 to authorize extending the dental caries health claim to include isomaltulose.

Specific requirements for use of the dental caries health claim are provided in § 101.80(c)(2). Section 101.80(c)(2)(ii) lists noncariogenic carbohydrate sweeteners eligible for the health claim. Eligible sugar alcohols, sugars, and non-nutritive sweeteners are listed in § 101.80(c)(2)(ii)(A), (B), and (C), respectively. FDA is amending § 101.80(c)(2)(ii)(B) to include isomaltulose as an additional eligible noncariogenic sugar. Section 101.80(c)(2)(iii) specifies eligibility criteria for a food to bear the health claim on its label. The first criterion in this paragraph is that the food be “sugar free,” as defined in § 101.60(c)(1)(i), except that the food may contain D-tagatose (§ 101.80(c)(2)(iii)(A)). FDA is amending § 101.80(c)(2)(iii)(A) to include isomaltulose, in addition to D-tagatose, in the exception to the “sugar free” criterion of eligible foods.

Section 101.80(e) provides examples of statements that meet the requirements to make a health claim about nonpromotion of dental caries. FDA emphasizes that these “model health claims” are illustrative only. These model claims illustrate both the elements of the health claim statement required under § 101.80(c)(2)(i) and some of the optional elements permitted under § 101.80(d). FDA is amending § 101.80 to add isomaltulose as an additional noncariogenic carbohydrate sweetener eligible for the health claim, and is not approving specific wording of claim statements. Manufacturers continue to be free to design their own claim so long as it is consistent with agency regulations.

Under § 101.80(c)(2)(i)(H), there is a requirement that when the substance that is the subject of the claim is a noncariogenic sugar, the claim shall identify the substance as a sugar that, unlike other sugars, does not promote the development of dental caries. This requirement was added to § 101.80, along with the addition of the sugar D-tagatose as a sweetener eligible for the claim, to address the potential incongruity arising from a sugar-containing food bearing a dental caries health claim stating that foods high in sugars promote tooth decay. The model health claim examples in § 101.80(e)(1)(iii) and (iv) and § 101.80(e)(2)(iii) and (iv) are examples of health claim statements for use with D-tagatose-containing foods. FDA is revising these model health claims to change from the specific sugar “tagatose” to “name of a sugar from paragraph (c)(2)(ii)(B) of this section” to be inclusive of either tagatose or isomaltulose, or other noncariogenic sugars that may be added to the rule in the future.

Current § 101.80(e)(1) consists of examples of the full claim, and § 101.80(e)(2) consists of examples of the shortened claim for use on packages with less than 15 square inches of surface area available for labeling. The “shortened claim” version provided for in § 101.80(c)(2)(i)(G) may omit: (1) Stating the relationship of frequent between-meal consumption of foods high in sugars and starches and the promotion of dental caries (§ 101.80(c)(2)(i)(A)), and (2) identification of the substance by name or as a sugar alcohol (§ 101.80(c)(2)(i)(C)). The “shortened claim” version, however, does not omit the requirement that when a noncariogenic sugar is the subject of the claim, the substance be identified in the claim statement as a sugar. As such, the model “shortened claims” provided by FDA in § 101.80(e)(2) identify by name either tagatose or isomaltulose.

FDA has examined the impacts of the interim final rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The agency believes that this interim final rule is not a significant regulatory action as defined by the Executive order.

The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because this interim final rule concerns voluntary claims, the agency certifies that the interim final rule will not have a significant economic impact on a substantial number of small entities.

Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $122 million, using the most current (2005) Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this interim final rule to result in any 1-year expenditure that would meet or exceed this amount.

FDA identified the following three options regarding this petition: (1) Deny the petition, (2) authorize the petition (add only isomaltulose to § 101.80), or (3) add isomaltulose to § 101.80 and also expand the scope of the claim to include all noncariogenic carbohydrate sweeteners. FDA concludes that authorizing the petition by adding only isomaltulose to the dental caries health claim is the best option of those identified.

The agency can only define costs and benefits relative to a baseline, and FDA usually selects the option of taking no action as the baseline because it helps readers identify the costs and benefits of actions that change the status quo. In this case, denying the petition would correspond to taking no action because it would imply no change in the dental caries health claim and thus the continuation of the status quo. By definition, the baseline itself has no costs or benefits. This does not mean that FDA ignores the costs and benefits of the baseline. Instead, it means that the agency expresses the costs and benefits of the baseline in how it calculates the costs and benefits of the other regulatory options.

This option would allow producers who use isomaltulose to use the dental caries health claim on their product labels under certain conditions. Producers would only choose to change product labels or reformulate products if they believe that doing so will increase profits more than the costs of making those changes. Providing this information may increase profits for some producers because some consumers may find this information valuable when choosing products. Some consumers may find this information valuable because it may allow them to reduce their risk of dental carries. FDA has determined that this information has sufficient scientific support and, when provided in labeling under certain conditions, is truthful and not misleading to consumers. Therefore, using the claims will not generate offsetting costs for consumers. The agency does not know how many producers will find it worthwhile to use this claim. However, if this interim final rule is finalized without change, it is sure that to whatever extent producers use the claim, both producers and consumers will be made better off under option two than under option one. The agency can conclude that adding isomaltulose to the dental caries health claim will generate either a net increase in social benefits or, if no producers find it worthwhile to use the claims, no impact on social welfare.

In the Federal Register of June 25, 2007 (72 FR 34959), FDA published an IFR with a 90-day comment period to request comments on a procedure for a petition to request an exemption from 100 percent identity testing of dietary ingredients. Comments on the exemption procedure will provide an opportunity for interested persons to comment on whether this exemption procedure should be modified, and if so, whether there is any additional information that may be helpful to articulate with respect to what a petition needs to show that may inform future guidance.

The agency has received a request for a 60-day extension of the comment period for the IFR. The request conveyed concern that the current 90-day comment period does not allow sufficient time to develop a meaningful or thoughtful response to the IFR.

FDA has considered the request and is extending the comment period for the IFR for 30 days, until October 24, 2007. The agency believes that a 30-day extension allows adequate time for interested persons to submit comments without significantly delaying rulemaking on these important issues.

Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments on this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

Regulations promulgated by the IHS to govern the administration of contracts under the Indian Self-Determination and Education Assistance Act reference a mailing address for the Claims Branch. The Claims Branch has moved its office to a new location. This action provides the new mailing address for filing medical-related claims with the Claims Branch.

IHS has determined that the public notice and comment provisions of the Administrative Procedure Act, 5 U.S.C. 553(b) do not apply to this rulemaking. The changes being made relate solely to procedure and practice. The changes therefore, meet the requirements for exemption from notice and comment in 5 U.S.C. 553(b)(A).

IHS has reviewed this rule under the following statutes and Executive Orders governing rulemaking procedures: The Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1501 et seq.; the Regulatory Flexibility Enforcement Act, 5 U.S.C. 601 et seq.; the Small Business Regulatory Enforcement Fairness Act of 1996, 5 U.S.C. 801 et seq.; the Paperwork Reduction Act, 4 U.S.C. 3501 et seq.; Executive Order 12630 (Takings); Executive Order 12866 (Regulatory Planning and Review); Executive Order 12988 (Civil Justice Reform); Executive Order 13132 (Federalism); Executive Order 13175 (Tribal Consultation); and Executive Order 13211 (Energy Impacts). IHS has determined that this rule does not trigger any of the procedural requirements of those statutes and Executive Orders, since this rule is technical in nature and merely changes the mailing address for the Claims Branch.

Throughout this document, “we,” “us” and “our” refer to EPA.

Table 1 lists the rule we are approving with the date that the amended rule was adopted by the local air agency and submitted by the California Air Resources Board (CARB).

On October 24, 2006, we determined the submittal of October 5, 2006 met the completeness criteria in 40 CFR part 51 appendix V, which must be met before formal EPA review.

We approved a version of San Bernardino County Air Pollution Control District Rule 442 into the SIP on June 9, 1982 (47 FR 25013). This rule remains effective in the portion of San Bernardino County that is under the MDAQMD's jurisdiction. We also approved a version of South Coast Air Quality Management District Rule 442 into the SIP on November 16, 1983 (48 FR 52054). This rule remains effective in the portion of Riverside County that is under the MDAQMD's jurisdiction.

VOCs help produce ground-level ozone and smog, which harm human health and the environment. Section 110(a) of the CAA requires states to submit regulations that control VOC emissions. This rule was developed as part of the local air district's programs to control these pollutants.

The purposes of the MDAQMD Rule 442 revisions relative to the SIP rule are as follows:

• The rule is revised to conform to present MDAQMD rule format and to be consistent with other District rules.

• Section (A)—This section has been renamed “General” to conform with standard MDAQMD rule format. Subsections (A)(1) `Purpose' and (A)(2) `Applicability' have been revised to update terminology to reflect current regulatory trends and to remove unnecessary and obsolete references.

• Section (B)—This section has been modified to update the terminology to reflect current regulatory trends. A variety of other terms have been added and revised to conform to definitions contained in Regulation XIII. The organic materials definition was revised to more accurately reflect language that could be used to demonstrate compliance with other District rules requiring recording and labeling of VOC materials.

• Section (C)—This section has been renamed “Requirements” and all procedural requirements have been moved to this section. The rule amendments remove restrictions to the use of non-photochemically reactive solvents and change the VOC usage restriction from 39.6 lbs/day to a monthly limit of 1190 lbs/month.

• Section (D)—This section has been renamed “Exemptions” because all exemptions have been moved to this section. An exemption for aerosol products has been added.

• Section (E)—This section has been renamed “Monitoring, Recordkeeping and Reporting.” The language in this section has been modified for consistency with other MDAQMD rules and regulations.

• Section (F)—This section has been named “Test Methods” and contains the methods for determining VOC content. Test methods have been defined and language has been updated for consistency with other MDAQMD rules and regulations.

• The current VOC emissions limit that allows disposal of up to 1.3 gallons per day of VOC by any means is made more stringent by prohibiting disposal of VOC in a manner that would allow evaporation of VOC into the atmosphere.

• The current emissions limit of 18 kg (39.6 pounds) per day of photochemically reactive solvents is converted to the monthly emission limit of 540 kg (1,190 pounds) of VOC per month.

• The current emissions limit for organic materials that come in contact with a flame, are baked, are heater cured, or are heat polymerized of 195 kg (429 pounds) per month is removed; however, the VOC emissions limit for these processes are covered by other rules in Regulations IV and XI.

• The current emissions limit deletes the 8,036 kg (18,000 pounds) per day limit for “non-photochemically reactive” solvents. A part of these solvents are covered by the “VOC” limit and a part do not have a limit because they are not precursors to ozone.

• A limit on VOC emissions from coating aerospace assemblies and a limit for tire manufactures expired by their own terms.

• Exemptions for high solid or ultra-high solid materials are removed due to a change in VOC terminology.

The revised Rule 442 will apply throughout the MDAQMD and will supersede the two SIP versions of the rule identified above.

EPA's technical support document (TSD) has more information about this rule.

Generally, SIP rules must be enforceable (see section 110(a) of the Act), must require Reasonably Available Control Technology (RACT) for major sources in nonattainment areas (see section 182(a)(2)(A)), and must not interfere with existing requirements concerning attainment of air quality standards (see section 110(1)) or relax existing control requirements (see section 193). The MDAQMD regulates an 8-hour ozone nonattainment area (see 40 CFR part 81). However, RACT is not required for Rule 442, because no major sources of VOC are expected to be covered by Rule 442. Major sources are covered by other rules in Regulations IV and XI.

Guidance and policy documents that we used to evaluate the enforceability and legal sufficiency of this rule include the following:

1. “Requirements for Preparation, Adoption, and Submittal of Implementation Plans,” U.S. EPA, 40 CFR part 51.

2. “Issues Relating to VOC Regulation Cutpoints, Deficiencies, and Deviations,” EPA, May 25, 1988 (the Bluebook).

3. “Guidance Document for Correcting Common VOC & Other Rule Deficiencies,” EPA Region 9, August 21, 2001 (the Little Bluebook).

4. “Review of State Implementation Plans and Revisions for Enforceability and Legal Sufficiency,” September 23, 1987.

5. “General Preamble for the Implementation of Title I of the Clean Air Act Amendments of 1990,” at 57 FR 13498, April 16, 1992.

We believe the rule is consistent with the relevant requirements and policy regarding enforceability, legal sufficiency, and SIP relaxations. The TSD has more information on our evaluation.

The TSD describes additional rule revisions that do not affect EPA's current action but are recommended for the next time the local agency modifies the rule.

As authorized in section 110(k)(3) of the Act, EPA is fully approving the submitted MDAQMD Rule 442 because we believe it fulfills all relevant requirements. We do not think anyone will object to this approval, so we are finalizing it without proposing it in advance. However, in the Proposed Rules section of this Federal Register , we are simultaneously proposing approval of the same submitted rule. If we receive adverse comments by October 17, 2007, we will publish a timely withdrawal in the Federal Register to notify the public that the direct final approval will not take effect and we will address the comments in a subsequent final action based on the proposal. If we do not receive timely adverse comments, the direct final approval will be effective without further notice on November 16, 2007. This will incorporate the rule into the federally enforceable SIP.

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).

This rule also does not have tribal implications because it will 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, 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 November 16, 2007. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

The NFIP enables property owners to purchase flood insurance which is generally not otherwise available. In return, communities agree to adopt and administer local floodplain management aimed at protecting lives and new construction from future flooding. Section 1315 of the National Flood Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits flood insurance coverage as authorized under the NFIP, 42 U.S.C. 4001 et seq. , unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed in this document no longer meet that statutory requirement for compliance with program regulations, 44 CFR part 59. Accordingly, the communities will be suspended on the effective date in the third column. As of that date, flood insurance will no longer be available in the community. However, some of these communities may adopt and submit the required documentation of legally enforceable floodplain management measures after this rule is published but prior to the actual suspension date. These communities will not be suspended and will continue their eligibility for the sale of insurance. A notice withdrawing the suspension of the communities will be published in the Federal Register .

In addition, FEMA has identified the Special Flood Hazard Areas (SFHAs) in these communities by publishing a Flood Insurance Rate Map (FIRM). The date of the FIRM, if one has been published, is indicated in the fourth column of the table. No direct Federal financial assistance (except assistance pursuant to the Robert T. Stafford Disaster Relief and Emergency Assistance Act not in connection with a flood) may legally be provided for construction or acquisition of buildings in identified SFHAs for communities not participating in the NFIP and identified for more than a year, on FEMA's initial flood insurance map of the community as having flood-prone areas (section 202(a) of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4106(a), as amended). This prohibition against certain types of Federal assistance becomes effective for the communities listed on the date shown in the last column. The Administrator finds that notice and public comment under 5 U.S.C. 553(b) are impracticable and unnecessary because communities listed in this final rule have been adequately notified.

Each community receives 6-month, 90-day, and 30-day notification letters addressed to the Chief Executive Officer stating that the community will be suspended unless the required floodplain management measures are met prior to the effective suspension date. Since these notifications were made, this final rule may take effect within less than 30 days.

National Environmental Policy Act. This rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Considerations. No environmental impact assessment has been prepared.

Regulatory Flexibility Act. The Administrator has determined that this rule is exempt from the requirements of the Regulatory Flexibility Act because the National Flood Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits flood insurance coverage unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed no longer comply with the statutory requirements, and after the effective date, flood insurance will no longer be available in the communities unless remedial action takes place.

Regulatory Classification. This final rule is not a significant regulatory action under the criteria of section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735.

Executive Order 13132, Federalism. This rule involves no policies that have federalism implications under Executive Order 13132.

Executive Order 12988, Civil Justice Reform. This rule meets the applicable standards of Executive Order 12988.

Paperwork Reduction Act. This rule does not involve any collection of information for purposes of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.

The Federal Emergency Management Agency (FEMA) makes the final determinations listed below for the modified BFEs for each community listed. These modified elevations have been published in newspapers of local circulation and ninety (90) days have elapsed since that publication. The Mitigation Division Director of FEMA has resolved any appeals resulting from this notification.

This final rule is issued in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part 67. FEMA has developed criteria for floodplain management in floodprone areas in accordance with 44 CFR part 60.

Interested lessees and owners of real property are encouraged to review the proof Flood Insurance Study and FIRM available at the address cited below for each community. The BFEs and modified BFEs are made final in the communities listed below. Elevations at selected locations in each community are shown.

National Environmental Policy Act. This final rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Consideration. An environmental impact assessment has not been prepared.

Regulatory Flexibility Act. As flood elevation determinations are not within the scope of the Regulatory Flexibility Act, 5 U.S.C. 601-612, a regulatory flexibility analysis is not required.

Regulatory Classification. This final rule is not a significant regulatory action under the criteria of section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735.

Executive Order 13132, Federalism. This final rule involves no policies that have federalism implications under Executive Order 13132.

Executive Order 12988, Civil Justice Reform. This final rule meets the applicable standards of Executive Order 12988.

The Federal Emergency Management Agency (FEMA) makes the final determinations listed below for the modified BFEs for each community listed. These modified elevations have been published in newspapers of local circulation and ninety (90) days have elapsed since that publication. The Mitigation Division Director of FEMA has resolved any appeals resulting from this notification.

This final rule is issued in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part 67. FEMA has developed criteria for floodplain management in floodprone areas in accordance with 44 CFR part 60.

Interested lessees and owners of real property are encouraged to review the proof Flood Insurance Study and FIRM available at the address cited below for each community. The BFEs and modified BFEs are made final in the communities listed below. Elevations at selected locations in each community are shown.

National Environmental Policy Act. This final rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Consideration. An environmental impact assessment has not been prepared.

Regulatory Flexibility Act. As flood elevation determinations are not within the scope of the Regulatory Flexibility Act, 5 U.S.C. 601-612, a regulatory flexibility analysis is not required.

Regulatory Classification. This final rule is not a significant regulatory action under the criteria of section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735.

Executive Order 13132, Federalism. This final rule involves no policies that have federalism implications under Executive Order 13132.

Executive Order 12988, Civil Justice Reform. This final rule meets the applicable standards of Executive Order 12988.

This is a synopsis of the Commission's Report and Order , MB Docket No. 05-282, adopted June 13, 2007, and released June 15, 2007. The full text of this Commission decision is available for inspection and copying during normal business hours in the FCC Reference Information Center (Room CY-A257), 445 12th Street, SW., Washington, DC 20554. The complete text of this decision may also be purchased from the Commission's copy contractor, Best Copy and Printing, Inc., Portals II, 445 12th Street, SW., Room CY-B402, Washington, DC 20554, telephone 1-800-378-3160 or http://www.BCPIWEB.com . The Commission will send a copy of this Report and Order in a report to be sent to Congress and the Government Accountability Office pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A).

Every FM channel change set forth in the Report and Order formerly required rule changes to Section 73.202(b), the FM Table of Allotments. See 70 FR 66329 (November 2, 2005). As a result of changes to the Commission's processing rules, modifications of FM channels for existing stations are no longer listed in Section 73.202(b) and are instead reflected in the Media Bureau's Consolidated Data Base System (CDBS). See Revision of Procedures Governing Amendments to FM Table of Allotments and Changes of Community of License in the Radio Broadcast Services, Report and Order , 21 FCC Rcd 14212 (December 20, 2006). Only the substitution of Channel 230A for vacant Channel 296A at Lynchburg, Tennessee, which involves an amendment to Section 73.202(b), is summarized and published in the Federal Register . Although the Report and Order , as revised, sets forth an effective date of October 8, 2007, the amendment to the FM Table of Allotments and the specified FM license modifications will be effective 30 days after publication of this summary in the Federal Register in compliance with Sections 1.427 and 1.429 of the Commission's rules.