Unknown. Final special conditions; request for comments

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A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

--- schema: federal-register doc_type: fedreg source_file: FR-2007-07-19.xml --- 72 138 Thursday, July 19, 2007 Contents Agriculture Agriculture Department See Forest Service Antitrust Antitrust Division NOTICES National cooperative research notifications: Digital Body Development System, 39641-39642 07-3514 Arts Arts and Humanities, National Foundation See National Foundation on the Arts and the Humanities Centers Centers for Disease Control and Prevention NOTICES Agency information collection activities; proposals, submissions, and approvals, 39622-39623 E7-13985 Coast Guard Coast Guard RULES Vocational rehabilitation and education:

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Model SA160 airplane, 39555-39557 E7-14050 PROPOSED RULES Airworthiness directives: Cessna, 39584-39586 E7-13984 NOTICES Agency information collection activities; proposals, submissions, and approvals, 39658 07-3504 Environmental statements; notice of intent: Golden Triangle Regional Airport, MS; property release, 39658-39659 07-3505 Exemption petitions; summary and disposition, E7-13936 39659-39660 E7-13937 FCC Federal Communications Commission PROPOSED RULES Radio frequency devices: 57-64 GHz band; unlicensed devices, 39588-39593 E7-13832 Federal Election Federal Election Commission PROPOSED RULES Bipartisan Campaign Reform Act; implementation:

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Medical devices that include antimicrobial agents; premarket notification submissions, 39630-39631 E7-13952 Pulse oximeters; premarket notification submissions, 39631-39632 E7-14012 Human drugs: Drug products not withdrawn from sale for reasons other than safety or effectiveness— BRETHINE (Terbutaline sulfate) Injection, 39629-39630 E7-13950 Forest Forest Service NOTICES Meetings: California Coast Provincial Advisory Committee, 39605 07-3515 Health Health and Human Services Department See Centers for Disease Control and Prevention See Food and Drug Administration See National Institutes of Health Homeland Homeland Security Department See Coast Guard Housing Housing and Urban Development Department NOTICES Agency information collection activities; proposals, submissions, and approvals, 39635-39636 E7-13892 Interior Interior Department See Fish and Wildlife Service See Land Management Bureau Justice Justice Department See Antitrust Division NOTICES Pollution control; consent judgments:

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Alaska; fisheries of Exclusive Economic Zone— Greenland turbot, 39581 07-3501 Shortraker rockfish, 39580-39581 07-3500 Northeastern United States fisheries— Atlantic sea scallop, 39580 07-3499 NOTICES Meetings: Mid-Atlantic Fishery Management Council, 39605-39606 E7-13978 Small coastal shark 2007 peer review workshop, 39606 E7-13953 Scientific research permit applications, determinations, etc.:, 39607 E7-13949 Personnel Personnel Management Office PROPOSED RULES Political activity;

Federal employees residing in designated localities: Fauquier County, VA, 39582-39583 E7-14003 Postal Postal Service NOTICES Meetings; Sunshine Act, 39644-39645 07-3549 Presidential Presidential Documents EXECUTIVE ORDERS Iraq; blocking property of persons who threaten stabilization efforts (EO 13438), 39717-39721 07-3552 ADMINISTRATIVE ORDERS Iraq; waiver of limitation on use of economic support funds (Presidential Determination) No. 2007-27 of July 12, 2007, 39725 07-3551 Overseas Private Investment Corporation; transfer of economic support funds to establish a loan guarantee program (Presidential Determination) No. 2007-26 of July 10, 2007, 39723 07-3550 Railroad Railroad Retirement Board NOTICES Agency information collection activities; proposals, submissions, and approvals, 39645 E7-13982 SEC Securities and Exchange Commission PROPOSED RULES Securities:

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To subscribe to the Federal Register Table of Contents LISTSERV electronic mailing list, go to http://listserv.access.gpo.gov and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions. 72 138 Thursday, July 19, 2007 Rules and Regulations DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 23 [Docket No. CE271, Special Condition 23-211-SC] Special Conditions; Symphony Aircraft Industries, Inc.

Model SA160; Protection of Systems for High Intensity Radiated Fields

(HIRF)AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Final special conditions; request for comments. SUMMARY: These special conditions are issued to Symphony Aircraft Industries, Inc. for a type design change to the SA160 airplane. This airplane will have novel and unusual design features when compared to the state of technology envisaged in the applicable airworthiness standards. These novel and unusual design features include the installation of electronic flight instrument system

(EFIS)displays (Entegra Avionics Suite) manufactured by Avidyne Corporation for which the applicable regulations do not contain adequate or appropriate airworthiness standards for the protection of these systems from the effects of high intensity radiated fields (HIRF). These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to the airworthiness standards applicable to these airplanes. DATES: The effective date of these special conditions is July 6, 2007. Comments must be received on or before August 20, 2007. ADDRESSES: Mail two copies of your comments to: Federal Aviation Administration, Regional Counsel, ACE-7, Attention: Rules Docket Clerk, Docket No. CE271, Room 506, 901 Locust, Kansas City, Missouri 64106. All comments must be marked: Docket No. CE271. You may inspect comments in the Rules Docket weekdays, except Federal holidays, between 7:30 a.m. and 4 p.m. FOR FURTHER INFORMATION CONTACT: Jim Brady, Aerospace Engineer, Standards Office (ACE-111), Small Airplane Directorate, Aircraft Certification Service, Federal Aviation Administration, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone

(816)329-4132. SUPPLEMENTARY INFORMATION: The FAA has determined that notice and opportunity for prior public comment hereon are impracticable because these procedures would significantly delay issuance of the approval design and thus delivery of the affected aircraft. In addition, the substance of these special conditions has been subject to the public comment process in several prior instances with no substantive comments received. The FAA, therefore, finds that good cause exists for making these special conditions effective upon issuance. Comments Invited We invite interested persons to take part in this rulemaking by sending written data, views, or comments. Identify the regulatory docket or notice number and submit two copies to the address specified above. The most helpful comments reference a specific portion of the special conditions, explain the reason for any recommended change, and include supporting data. We will file in the docket all comments we receive on or before the closing date as well as a report summarizing each substantive public contact with FAA personnel about these special conditions. All comments received will be available in the Rules Docket for examination by interested persons, both before and after the closing date for comments. We will consider all comments we receive by the closing date for comments. We will consider comments filed late if it is possible to do so without incurring expense or delay. Based on the comments we receive, we may change these special conditions. If you want the FAA to acknowledge receipt of your comments, include a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. CE271.” The postcard will be date stamped and we will mail it back to you. Background On November 11, 2006, Symphony Aircraft Industries, Inc. applied to the FAA for a type design change to the SA160 airplane. The Symphony Aircraft SA160 is currently approved under TC No. A46CE. The proposed modification incorporates a novel or unusual design feature, such as digital avionics consisting of an EFIS that is vulnerable to HIRF external to the airplane. Type Certification Basis Under the provisions of 14 CFR part 21, § 21.101, Symphony Aircraft Industries, Inc. must show that the SA160 aircraft design change meets the following provisions, or the applicable regulations in effect on the date of application for the change to the project: Cert basis, 14 CFR part 23 effective February 1, 1965, including Amendments 23-1 through 23-53; 14 CFR part 36 effective November 18, 1969, including Amendments 36-1 through 36-22; as applicable, and § 23.1301 of Amendment 23-20; §§ 23.1309, 23.1311, and 23.1321 of Amendment 23-49; and § 23.1322 of Amendment 23-43; exemptions, if any; and the special conditions adopted by this rulemaking action. Discussion If the Administrator finds that the applicable airworthiness standards do not contain adequate or appropriate safety standards because of novel or unusual design features of an airplane, special conditions are prescribed under the provisions of § 21.16. Special conditions, as appropriate, as defined in § 11.19, are issued in accordance with § 11.38 after public notice and become part of the type certification basis in accordance with § 21.101 (b)(2). Special conditions are initially applicable to the model for which they are issued. Should the applicant apply for a supplemental type certificate to modify any other model already included on the same type certificate to incorporate the same novel or unusual design feature, the special conditions would also apply to the other model under the provisions of § 21.101. Novel or Unusual Design Features Symphony Aircraft Industries, Inc. plans to incorporate certain novel and unusual design features into an airplane for which the airworthiness standards do not contain adequate or appropriate safety standards for protection from the effects of HIRF. These features include EFIS, which are susceptible to the HIRF environment, that were not envisaged by the existing regulations for this type of airplane. *Protection of Systems From High Intensity Radiated Fields (HIRF):* Recent advances in technology have given rise to the application in aircraft designs of advanced electrical and electronic systems that perform functions required for continued safe flight and landing. Due to the use of sensitive solid state advanced components in analog and digital electronics circuits, these advanced systems are readily responsive to the transient effects of induced electrical current and voltage caused by the HIRF. The HIRF can degrade electronic systems performance by damaging components or upsetting system functions. Furthermore, the HIRF environment has undergone a transformation that was not foreseen when the current requirements were developed. Higher energy levels are radiated from transmitters that are used for radar, radio, and television. Also, the number of transmitters has increased significantly. There is also uncertainty concerning the effectiveness of airframe shielding for HIRF. Furthermore, coupling to cockpit-installed equipment through the cockpit window apertures is undefined. The combined effect of the technological advances in airplane design and the changing environment has resulted in an increased level of vulnerability of electrical and electronic systems required for the continued safe flight and landing of the airplane. Effective measures against the effects of exposure to HIRF must be provided by the design and installation of these systems. The accepted maximum energy levels in which civilian airplane system installations must be capable of operating safely are based on surveys and analysis of existing radio frequency emitters. These special conditions require that the airplane be evaluated under these energy levels for the protection of the electronic system and its associated wiring harness. These external threat levels, which are lower than previous required values, are believed to represent the worst case to which an airplane would be exposed in the operating environment. These special conditions require qualification of systems that perform critical functions, as installed in aircraft, to the defined HIRF environment in paragraph 1 or, as an option to a fixed value using laboratory tests, in paragraph 2, as follows:

(1)The applicant may demonstrate that the operation and operational capability of the installed electrical and electronic systems that perform critical functions are not adversely affected when the aircraft is exposed to the HIRF environment defined below: Frequency Field strength (volts per meter) Peak Average 10 kHz-100 kHz 50 50 100 kHz-500 kHz 50 50 500 kHz-2 MHz 50 50 2 MHz-30 MHz 100 100 30 MHz-70 MHz 50 50 70 MHz-100 MHz 50 50 100 MHz-200 MHz 100 100 200 MHz-400 MHz 100 100 400 MHz-700 MHz 700 50 700 MHz-1 GHz 700 100 1 GHz-2 GHz 2000 200 2 GHz-4 GHz 3000 200 4 GHz-6 GHz 3000 200 6 GHz-8 GHz 1000 200 8 GHz-12 GHz 3000 300 12 GHz-18 GHz 2000 200 18 GHz-40 GHz 600 200 The field strengths are expressed in terms of peak root-mean-square

(rms)values. or,

(2)The applicant may demonstrate by a system test and analysis that the electrical and electronic systems that perform critical functions can withstand a minimum threat of 100 volts per meter peak rms, electrical field strength, from 10 kHz to 18 GHz. When using this test to show compliance with the HIRF requirements, no credit is given for signal attenuation due to installation. A preliminary hazard analysis must be performed by the applicant, for approval by the FAA, to identify either electrical or electronic systems that perform critical functions. The term “critical” means those functions whose failure would contribute to, or cause, a failure condition that would prevent the continued safe flight and landing of the airplane. The systems identified by the hazard analysis that perform critical functions are candidates for the application of HIRF requirements. A system may perform both critical and non-critical functions. Primary electronic flight display systems, and their associated components, perform critical functions such as attitude, altitude, and airspeed indication. The HIRF requirements apply only to critical functions. Compliance with HIRF requirements may be demonstrated by tests, analysis, models, similarity with existing systems, or any combination of these. Service experience alone is not acceptable since normal flight operations may not include an exposure to the HIRF environment. Reliance on a system with similar design features for redundancy as a means of protection against the effects of external HIRF is generally insufficient since all elements of a redundant system are likely to be exposed to the fields concurrently. Applicability As discussed above, these special conditions are applicable to the SA160 Avidyne Entegra Avionics Suite project. Should Symphony Aircraft Industries, Inc. apply at a later date for a supplemental type certificate to modify any other model on the same type certificate to incorporate the same novel or unusual design feature, the special conditions would apply to that model as well under the provisions of § 21.101. Conclusion This action affects only certain novel or unusual design features on one model of airplane. It is not a rule of general applicability and affects only the applicant who applied to the FAA for approval of these features on the airplane. The substance of these special conditions has been subjected to the notice and comment period in several prior instances and has been derived without substantive change from those previously issued. It is unlikely that prior public comment would result in a significant change from the substance contained herein. For this reason, and because a delay would significantly affect the certification of the airplane, which is imminent, the FAA has determined that prior public notice and comment are unnecessary and impracticable, and good cause exists for adopting these special conditions upon issuance. The FAA is requesting comments to allow interested persons to submit views that may not have been submitted in response to the prior opportunities for comment described above. List of Subjects in 14 CFR Part 23 Aircraft, Aviation safety, Signs and symbols. Citation The authority citation for these special conditions is as follows: Authority: 49 U.S.C. 106(g), 40113 and 44701; 14 CFR 21.16 and 21.101; and 14 CFR 11.38 and 11.19. The Special Conditions Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for SA160 Avidyne Entegra Avionics Suite Project airplane modified by Symphony Aircraft Industries, Inc. to add an EFIS. 1. Protection of Electrical and Electronic Systems from High Intensity Radiated Fields (HIRF). Each system that performs critical functions must be designed and installed to ensure that the operations, and operational capabilities of these systems to perform critical functions, are not adversely affected when the airplane is exposed to high intensity radiated electromagnetic fields external to the airplane. 2. For the purpose of these special conditions, the following definition applies: *Critical Functions:* Functions whose failure would contribute to, or cause, a failure condition that would prevent the continued safe flight and landing of the airplane. Issued in Kansas City, Missouri, on July 6, 2007. David R. Showers, Acting Manager, Small Airplane Directorate, Aircraft Certification Service. [FR Doc. E7-14050 Filed 7-18-07; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 179 [Docket No. 1994F-0008 (formerly Docket No. 94F-0008)] Irradiation in the Production, Processing and Handling of Food AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; response to objections and denial of requests for a hearing. SUMMARY: The Food and Drug Administration

(FDA)is responding to objections and is denying the requests that it has received for a hearing on the final rule that amended the food additive regulations to authorize the use of a machine source of high energy x-rays to inspect cargo containers that may contain food. After reviewing the objections to the final rule and the requests for a hearing, the agency has concluded that the objections do not raise issues of material fact that justify a hearing or otherwise provide a basis for revoking or modifying the amendment to the regulation. FOR FURTHER INFORMATION CONTACT: Andrew J. Zajac, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1267. SUPPLEMENTARY INFORMATION: I. Introduction In the **Federal Register** of February 24, 1994 (59 FR 8995), FDA published a notice announcing the filing of a petition (FAP 4M4407) submitted by Analytical Systems Engineering Corp.

(ASEC)(now ACS Defense, Inc.) to amend the food additive regulations in § 179.21 *Sources of radiation used for inspection of food, for inspection of packaged food, and for controlling food processing* (21 CFR 179.21) to provide for the safe use of machine sources of high energy x-rays to inspect cargo containers that may contain food. The rights to the petition were subsequently transferred to R. F. Reiter and Associates. In response to the petition, FDA issued a final rule in the **Federal Register** of April 10, 2001 (66 FR 18537), permitting the use of x-rays produced by machine sources of 10 million electron volts

(MeV)or lower to inspect food, providing that no food receives a dose in excess of 0.5 gray (Gy). This rule will be referred to in this document as the “cargo inspection final rule.” The preamble to the final rule advised that objections to the final rule and requests for a hearing were due within 30 days of the publication date (i.e., by May 10, 2001). II. Objections and Requests for a Hearing Section 409(f) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 348(f)), provides that, within 30 days after publication of an order relating to a food additive regulation, any person adversely affected by such order may file objections, “specifying with particularity the provisions of the order deemed objectionable, stating reasonable grounds therefor, and requesting a public hearing upon such objections.” FDA may deny a hearing request if the objections to the regulation do not raise genuine and substantial issues of fact that can be resolved at a hearing. ( *Community Nutrition Institute* v. *Young* , 773 F. 2d 1356, 1364 (D.C. Cir. 1985), *cert. denied* , 475 U.S. 1123 (1986)). Under the food additive regulations at 21 CFR 171.110, objections and requests for a hearing are governed by part 12 (21 CFR part 12) of FDA's regulations. Under § 12.22(a), each objection must meet the following conditions:

(1)Must be submitted on or before the 30th day after the date of publication of the final rule;

(2)must be separately numbered;

(3)must specify with particularity the provision of the regulation or proposed order objected to;

(4)must specifically state each objection on which a hearing is requested; failure to request a hearing on an objection constitutes a waiver of the right to a hearing on that objection; and

(5)must include a detailed description and analysis of the factual information to be presented in support of the objection if a hearing is requested; failure to include a description and analysis for an objection constitutes a waiver of the right to a hearing on that objection. Following publication of the cargo inspection final rule, FDA received a letter from Public Citizen within the 30-day objection period. Public Citizen sought revocation of the final rule based on three objections and requested a hearing on issues raised by each objection. III. Standards for Granting a Hearing Specific criteria for deciding whether to grant or deny a request for a hearing are set out in § 12.24(b). Under that regulation, a hearing will be granted if the material submitted by the requester shows, among other things, the following:

(1)There is a genuine and substantial factual issue for resolution at a hearing; a hearing will not be granted on issues of policy or law;

(2)the factual issue can be resolved by available and specifically identified reliable evidence; a hearing will not be granted on the basis of mere allegations or denials or general descriptions of positions and contentions;

(3)the data and information submitted, if established at a hearing, would be adequate to justify resolution of the factual issue in the way sought by the requestor; a hearing will be denied if the data and information submitted are insufficient to justify the factual determination urged, even if accurate;

(4)resolution of the factual issue in the way sought by the person is adequate to justify the action requested; a hearing will not be granted on factual issues that are not determinative with respect to the action requested (e.g., if the action would be the same even if the factual issue were resolved in the way sought);

(5)the action requested is not inconsistent with any provision in the act or any FDA regulation; and

(6)the requirements in other applicable regulations, e.g., 21 CFR 10.20, §§ 12.21 and 12.22, and in the notice issuing the final requlation or the notice of opportunity for hearing are met. A party seeking a hearing is required to meet a “threshold burden of tendering evidence suggesting the need for a hearing” ( *Costle* v. *Pacific Legal Foundation* , 445 U.S. 198, 214-215 (1980), *reh. denied* , 446 U.S. 947 (1980), citing *Weinberger* v. *Hynson, Westcott & Dunning, Inc.* , 412 U.S. 609, 620-621 (1973)). An allegation that a hearing is necessary to “sharpen the issues” or to “fully develop the facts” does not meet this test ( *Georgia Pacific Corp.* v. * EPA* , 671 F.2d 1235, 1241 (9th Cir. 1982)). If a hearing request fails to identify any factual evidence that would be the subject of a hearing, there is no point in holding one. In judicial proceedings, a court is authorized to issue summary judgment without an evidentiary hearing whenever it finds that there are no genuine issues of material fact in dispute and a party is entitled to judgment as a matter of law (see Rule 56, Federal Rules of Civil Procedure). The same principle applies in administrative proceedings (see § 12.28). A hearing request must not only contain evidence, but that evidence should raise a material issue of fact concerning which a meaningful hearing might be held ( *Pineapple Growers Ass'n* v. *FDA* , 673 F.2d 1083, 1085 (9th Cir. 1982)). Where the issues raised in the objection are, even if true, legally insufficient to alter the decision, the agency need not grant a hearing (see *Dyestuffs and Chemicals, Inc.* v. *Flemming* , 271 F.2d 281 (8th Cir. 1959), *cert. denied* , 362 U.S. 911 (1960)). FDA need not grant a hearing in each case where an objector submits additional information or posits a novel interpretation of existing information (see *United States* v. *Consolidated Mines & Smelting Co.* , 455 F.2d 432 (9th Cir. 1971)). In other words, a hearing is justified only if the objections are made in good faith and if they “draw in question in a material way the underpinnings of the regulation at issue” ( *Pactra Industries* v. *CPSC* , 555 F.2d 677 (9th Cir. 1977)). Finally, courts have uniformly recognized that a hearing need not be held to resolve questions of law or policy (see *Citizens for Allegan County, Inc.* v. *FPC* , 414 F.2d 1125 (D.C. Cir. 1969); *Sun Oil Co.* v. *FPC* , 256 F.2d 233, 240 (5th Cir.), *cert. denied* , 358 U.S. 872 (1958)). Even if the objections raise material issues of fact, FDA need not grant a hearing if those same issues were adequately raised and considered in an earlier proceeding. Once an issue has been so raised and considered, a party is estopped from raising that same issue in a later proceeding without new evidence. The various judicial doctrines dealing with finality can be validly applied to the administrative process. In explaining why these principles “self-evidently” ought to apply to an agency proceeding, the U.S. Court of Appeals for the District of Columbia Circuit wrote: “The underlying concept is as simple as this: Justice requires that a party have a fair chance to present his position. But overall interests of administration do not require or generally contemplate that he will be given more than a fair opportunity.” *Retail Clerks Union, Local 1401* v. *NLRB* , 463 F.2d 316, 322 (D.C. Cir. 1972). (See *Costle* v. *Pacific Legal Foundation* , supra at 215-220. See also *Pacific Seafarers, Inc.* v. *Pacific Far East Line, Inc.* , 404 F.2d 804 (D.C. Cir. 1968), *cert denied* , 393 U.S. 1093 (1969).) In summary, a hearing request must present sufficient credible evidence to raise a material issue of fact and the evidence must be adequate to resolve the issue as requested and to justify the action requested. IV. Analysis of Objections and Response to Hearing Requests The objections to the cargo inspection final rule pertain to FDA's safety determination. FDA addresses each of the objections below, as well as the data and information filed in support of each, comparing each objection and the information submitted in support of it to the standards for granting a hearing in § 12.24. A. Safety of Irradiation for Inspection of Cargo Containers Under 21 CFR 170.3(i), safety of a food additive means that there is a reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use. FDA's regulations reflect the congressional judgment that the additive must be properly tested and such tests carefully evaluated, but that the additive need not, indeed cannot, be shown to be safe to an absolute certainty. The House Report on the Food Additives Amendment of 1958 stated: “Safety requires proof of a reasonable certainty that no harm will result from the proposed use of the additive. It does not—and cannot—require proof beyond any possible doubt that no harm will result under any conceivable circumstance” (H. Rept. 2284, 85th Cong., 2d sess., 1958). The cargo inspection final rule discussed in detail FDA's evaluation of the safety of radiation for inspection of cargo containers that may contain food (66 FR 18537). Under that regulation, machine sources producing x-rays at energies no greater than 10 MeV may be used to inspect containers of food, provided that the absorbed dose not exceed 0.5 Gy. Among the reports submitted in the petition or that FDA identified in scientific publications, the agency explicitly cited three in its final rule. These reports, which were among the most recent studies or reviews, assessed the potential for induced radioactivity in food by experimental measurement and theoretical calculation, and provided the primary basis for FDA's conclusion regarding safety of the petitioned use of 10 MeV x-rays at a dose not to exceed 0.5 Gy. One of the reports is from the World Health Organization (WHO). This WHO report concluded that no detectable radioactivity will be induced in foodstuffs by x-rays with a maximum energy level of 10 MeV when a radiation dose of 0.5 Gy is not exceeded. The second report (Wakeford and Blackburn, 1991) discussed a study investigating the radioactivity induced in codfish, rice, and a macerated meat product irradiated with high energy bremsstrahlung 1 x-rays produced by an electron linear accelerator that generated electrons at energies up to 12 MeV and predominantly at 8 MeV. The authors reported that the bremsstrahlung x-rays used to irradiate the food had a maximum energy in the region of 10 MeV. These foods received radiation doses ranging from 8.8 to 14 kilogray (kGy), which is 17,600 to 28,000 times higher than the 0.5 Gy maximum dose permitted by the final rule. Induced activities in the foods from the bremsstrahlung x-rays were reported to be extremely small and of the same order as natural background levels, and any induced activities dropped quickly. 1 Bremsstrahlung refers to the type of x-rays that are emitted when high-speed electrons are suddenly decelerated due to interactions with atomic nuclei. X-rays also can be produced when accelerated electrons have sufficient energy to eject electrons from the inner shells of atoms. As outer-shell electrons move in to fill the vacancies in the lower energy level, x-rays are emitted, called characteristic x-rays. The third report (Findlay et al., 1992) summarized a study that investigated the induced radioactivity in chicken, prawns, cheeses, and spices irradiated with electron beams at two energies, 10 MeV and 20 MeV and at different doses up to 10 kGy. The authors noted that any induced radioactivity was due to photonuclear reactions resulting from bremsstrahlung x-rays and electronuclear reactions induced by the electron beams. The authors found that even when the food was irradiated with electrons at 20 MeV and doses at 10 kGy, the highest energy and dose tested, any induced activity was negligible after 1 day. 2 The authors reported that the measured values agreed well with calculated values. Based on the totality of the data and other relevant material evaluated by FDA, the agency concluded that no detectable radioactivity will be induced in food when an x-ray energy of 10 MeV and a dose of 0.5 Gy are not exceeded, and that the use of x-rays, produced by a machine source at energies of 10 MeV or lower, to inspect food, is safe. 2 The authors reported a specific activity after 1 day of 0.01 becquerel/gram. B. Objections Public Citizen contends that FDA has failed to demonstrate that the use of the subject additive is safe and gives three reasons for objecting to the final rule. Public Citizen requests a public hearing on their objections. First, Public Citizen contends that FDA's use of the conclusion in the WHO report that “no detectable radioactivity will be induced in foodstuffs when an x-ray energy level of 10 MeV and a dose of 0.5 Gy are not exceeded” is flawed because the conclusion is based on an extrapolation of theoretical and experimental studies that the report does not reference. The WHO report states that “* * * relevant experimental data are available from studies designed to evaluate the use of activation analysis and the application of x-rays and electrons in food irradiation and medical uses at energy levels up to 24 MeV and at doses up to 50 kGy. Such studies, both theoretical and experimental, can be used to extrapolate downwards to a lower dose such as the 0.5 Gy considered for surveillance systems and that these studies show no evidence that detectable levels of radioactivity would be induced at these lower doses.” Although not specifically cited, it is clear that the experimental data referred to in the report are the data from studies that were discussed in several working papers that were presented to the WHO consultation group and several relevant published papers referenced in the WHO report. These working papers were included in the petition along with the WHO report. For example, one paper that discussed experimental and theoretical work concerning the possible induction of radionuclides in food by high energy x-ray systems used for cargo surveillance referenced several relevant studies, including one by Glass and Smith. 3 This particular study, which was submitted with the petition, examined isomer radioactivities in elements and food using a variety of radiation sources, including 4-24 MeV x-ray sources at doses up to 50 kGy. FDA is denying the request for a hearing on this point because a hearing will not be granted if there is no genuine and substantial factual issue to be resolved (§ 12.24(b)(1)). 3 R.A. Glass and H.D. Smith, “Radioactive Isomer Production in Foods by Gamma Rays and X-rays,” Stanford Research Institute Report S-594, No. 3 (DA 19-129-1QM-1511), 1960. Public Citizen has failed to submit any evidence that would call into question the scientific validity of extrapolation of results obtained at higher energy levels and radiation doses to draw conclusions regarding effects that might be produced at lower energy levels and doses. Public Citizen is merely alleging that this approach is scientifically unsound. FDA is denying the request for a hearing on this point because a hearing will not be granted on the basis of mere allegations or denials or general descriptions of positions or contentions (§ 12.24(b)(2)). In its second objection, Public Citizen contends that the Wakeford report is cited in the final rule to support the statement that electrons with energies of 8-10 MeV induced an extremely small level of radioactivity in various types of food, but that this statement is irrelevant to this petition because the petition concerns the use of x-rays. The objection further asserts that the statement in the final rule “FDA would not expect any detectable radioactivity above background in food resulting from the petitioned use,” is based on no data or evidence. Contrary to Public Citizen's contention, the Wakeford report did concern the use of x-rays. As referenced in the final rule, the report by Wakeford, Blackburn, and Swallow (FDA inadvertently omitted the name of the third co-author, A.J. Swallow), titled “Induction and Detection of Radioactivity in Foodstuffs Irradiated with 10 MeV Electrons and X-rays,” studied food irradiated with electron beams as well as with high energy bremsstrahlung x-rays. The authors state that the food was irradiated directly by 0-10 MeV x-rays to a maximum dose of 15-20 kGy (the results table shows an average dose ranging from 8.8 to 14 kGy, which is 17,600 to 28,000 times higher than the maximum permitted dose level under the final rule of 0.5 Gy). The authors concluded that the induced activity from the 0-10 MeV bremsstrahlung x-rays was extremely small. Public Citizen provided no information to support its contention that the radiation reported as x-rays in the Wakeford report is irrelevant to the safety review of the subject additive. FDA is denying the request for a hearing on this point because a hearing will not be held on the basis of mere allegations or denials or general descriptions of positions or contentions (§ 12.24(b)(2)). Similarly, the objection does not identify any evidence to support its assertion that FDA's conclusion is based on no data or evidence. The data and evidence relied upon by FDA is set out in the final rule. The Wakeford report, the WHO report and Findlay report are all part of the data relied upon by FDA in making its determination. FDA is denying the request for a hearing on this point because a hearing will not be held on the basis of mere allegations or denials or general descriptions of positions or contentions (§ 12.24(b)(2)). Public Citizen also states in its second objection that, according to the Wakeford report, x-rays of energy greater than 3 MeV could induce radioactivity, and four isotopes can be activated at x-ray energies below 5 MeV and cause neutron induced activity in food. Among the four isotopes, Public Citizen specifically mentions carbon-13, oxygen-17, and deuterium. The objection does not show that FDA failed to consider important information that would have altered the agency's conclusion that the x-rays at energies up to 10 MeV at the maximum proposed dose of 0.5 Gy will result in negligible amounts of induced radioactivity in food. Indeed, the WHO report cited in the final rule concluded that thresholds for inducing radioactivity in some isotopes is less than 10 MeV, but that the probability of radioactivity being induced under these conditions is so low that it would not be detected by methods that can determine activity that is only 1 percent of what occurs naturally in food. The language from the Wakeford report cited in the objection is consistent with the conclusions in the WHO report. Public Citizen identifies no information to support a conclusion contrary to that reached by FDA. Therefore, FDA is denying the request for a hearing on this point because a hearing will not be held if there is no factual issue that can be resolved by available and specifically identified reliable evidence (§ 12.24(b)(2)). In its third objection, Public Citizen states that the Findlay report is not relevant to the petition because induction of radioactivity in food was studied using electron beams whereas the petition concerns the use of x-rays. In support of its assertion, Public Citizen references a report from the International Consultative Group on Food Irradiation titled “The Development of X-Ray Machines for Food Irradiation (Proceedings of a Consultants' Meeting),” dated October 1995 (ICGFI report), for its statement that “neutron activity produced by 5 MeV x-rays is in the order of 60 times greater than that produced by 10 MeV electrons.” However, contrary to Public Citizen's objection, the ICGFI report shows that the difference in expected neutron activation in irradiated food from electron beams and x-rays has been calculated, thereby permitting use of electron beam studies to estimate neutron activation expected from irradiation with x-rays. Public Citizen has offered no evidence to support its assertion that electron beam studies are inappropriate to support conclusions about x-ray irradiation. FDA is denying the request for a hearing on this point because the evidence submitted by Public Citizen in support of their argument, even if established at a hearing, would not be adequate to justify resolution of the factual issue in the way sought by the objector (§ 12.24(b)(3)). Moreover, it bears noting that the ICGFI report directly supports FDA's conclusion of safety in the final rule, when it cites 10 MeV x-rays at doses less than 0.5 Gy (the maximum energy and dosage in the final rule) as an example of “extremely low” dosage that “would not produce any significant radioactivity.” Public Citizen's reference to the conclusion in the ICGFI report that “increasing the energy of x-rays above 7.5 MeV would result in * * * possible induction of radioactivity in the irradiated food” is unavailing because that conclusion refers to the uses permitted by the Codex Alimentarius Commission for treating food at dosages up to 10 kGy, which is 20,000 times higher than the 0.5 Gy maximum dosage permitted by the final rule for inspecting food. Although Public Citizen alleged that the studies that FDA evaluated do not support the safety of x-rays of 10 MeV or lower used for inspection of cargo containers that may contain food, Public Citizen did not present any evidence that would have led to a different conclusion concerning the safety of the subject additive. Because Public Citizen's first and second objections provided no information to support their assertions regarding FDA's safety review, they provide no basis for FDA to reconsider its decision to issue the cargo inspection final rule. As noted previously, a hearing will not be granted on the basis of general descriptions of positions and contentions (see § 12.24(b)(1) and (b)(2)). Public Citizen's third objection relied on information that, even if established at a hearing, would not be adequate to justify resolution of the factual issue in the way sought by the objector. A hearing will be denied if the information submitted are insufficient to justify the factual determination urged, even if accurate (§ 12.24(b)(3)). The issues posed by Public Citizen in support of the objections do not justify the granting of a hearing. V. Summary and Conclusions The safety of x-rays produced by a machine source at energies of 10 MeV or lower, to inspect food irradiated at doses up to 0.5 Gy has been thoroughly tested, and the data have been reviewed by the agency. As discussed previously, FDA concluded that the available studies establish the safety of food for human consumption irradiated at doses up to 0.5 Gy as a result of being subjected to x-rays produced by a machine source at energies of 10 MeV or lower. The petitioner has the burden to demonstrate safety before FDA can approve the use of a food additive. Nevertheless, once the agency makes a finding of safety in an approval document, the burden shifts to an objector, who must come forward with evidence that calls into question FDA's conclusion ( *American Cyanamid Co.* v. *FDA* , 606 F. 2d 1307, 1314-1315 (D.C. Cir. 1979)). For the reasons set out previously, the objections do not raise genuine and substantial issues of fact supported by specifically identified reliable evidence that, if established at a hearing would be adequate to justify resolution in the way sought by Public Citizen. Therefore, Public Citizen's objections are not sufficient to justify a hearing under the requirements of § 12.24(b). Accordingly, FDA is overruling the objections and is denying the requests for a hearing. Dated: July 11, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-13947 Filed 7-18-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 573 [Docket No. 1998F-0196] (Formerly 98F-0196) Food Additives Permitted in Feed and Drinking Water of Animals; Selenium Yeast AGENCY: Food and Drug Administration, HHS ACTION: Final rule. SUMMARY: The Food and Drug Administration

(FDA)is amending the regulations for food additives permitted

(FAP)in feed to provide for the safe use of selenium yeast as a source of supplemental selenium in feed supplements for limit feeding for beef cattle and in salt mineral mixes for free-choice feeding for beef cattle. This action is in response to an amendment of a food additive petition filed by Alltech, Inc. DATES: This rule is effective July 19, 2007. Submit written or electronic objections and requests for a hearing by August 20, 2007. See section V of this document for information on the filing of objections. ADDRESSES: You may submit written or electronic objections and requests for a hearing identified by Docket No. 1998F-0196, by any of the following methods: *Electronic Submissions* Submit electronic objections in the following ways: • Federal eRulemaking Portal: *http://www.regulations.gov* . Follow the instructions for submitting comments. • Agency Web site: *http://www.fda.gov/dockets/ecomments* . Follow the instructions for submitting comments on the agency Web site. *Written Submissions* Submit written objections in the following ways: • Fax: 301-827-6870. • Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions]: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. To ensure more timely processing of objections, FDA is no longer accepting objections submitted to the agency by e-mail. FDA encourages you to continue to submit electronic objections by using the Federal eRulemaking Portal or the agency Web site, as described in the *Electronic Submissions* portion of this paragraph. *Instructions* : All submissions received must include the agency name and docket number for this rulemaking. All objections received will be posted without change to *http://www.fda.gov/ohrms/dockets/default.htm* , including any personal information provided. For detailed instructions on submitting objections, see the “Objections” heading of the SUPPLEMENTARY INFORMATION section of this document. *Docket* : For access to the docket to read background documents or objections received, go to *http://www.fda.gov/ohrms/dockets/default.htm* and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Isabel W. Pocurull, Center for Veterinary Medicine (HFV-226), 7519 Standish Pl., Rockville, MD 20855, 240-453-6853. SUPPLEMENTARY INFORMATION: I. Background In a notice published in the **Federal Register** of May 12, 1998 (63 FR 26193), FDA announced that a food additive petition (animal use) (FAP 2238) had been filed by Alltech Biotechnology Center, 3031 Catnip Hill Pike, Nicholasville, KY 40356. The petition proposed to amend the food additive regulations in § 573.920 *Selenium* (21 CFR 573.920) to provide for the safe use of selenium yeast as a source of selenium in feeds for poultry, swine, and cattle. Based on the information in the petition, the selenium food additive regulation was amended to include the use of selenium yeast in feed for chickens on June 6, 2000 (65 FR 35823). FDA sought additional data from the sponsor before approving use in other species. After these data were submitted for turkeys and swine, the selenium food additive regulation was amended to extend the use of selenium yeast in the complete feeds of turkeys and swine on July 17, 2002 (67 FR 46850). Additional data submitted by the sponsor and further amendments to the petition provided information to extend the use to beef and dairy cattle. Based on the information in the petition, the selenium food additive regulation was again amended to include the use of selenium yeast in the complete feed of beef and dairy cattle on September 3, 2003 (68 FR 52339). Additional data submitted by the sponsor and further amendments to the petition provided information for safe use of selenium yeast as a source of supplemental selenium in feed supplements for limit feeding for beef cattle and in salt mineral mixes for free-choice feeding for beef cattle. The notice of filing provided for a 60-day comment period on the petitioner's environmental assessment. No substantive comments have been received. II. Conclusion FDA concludes that the data establish the safety and utility of selenium yeast, for use as proposed and that the food additive regulations should be amended as set forth in this document. III. Public Disclosure In accordance with § 571.1(h) (21 CFR 571.1(h)), the petition and the documents that FDA considered and relied upon in reaching its decision to approve the petition will be made available for inspection at the Center for Veterinary Medicine by appointment with the information contact person (see FOR FURTHER INFORMATION CONTACT ). As provided in § 571.1(h), the agency will delete from the documents any materials that are not available for public disclosure before making the documents available for inspection. IV. Environmental Impact The agency has determined under 21 CFR 25.32(r), that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment, nor an environmental impact statement is required. V. Objections and Hearing Requests Any person who will be adversely affected by this regulation may file with the Division of Dockets Management (see ADDRESSES ) written or electronic objections. Each objection shall be separately numbered, and each numbered objection shall specify with particularity the provisions of the regulation to which objection is made and the grounds for the objection. Each numbered objection on which a hearing is requested shall specifically so state. Failure to request a hearing for any particular objection shall constitute a waiver of the right to a hearing on that objection. Each numbered objection for which a hearing is requested shall include a detailed description and analysis of the specific factual information intended to be presented in support of the objection in the event that a hearing is held. Failure to include such a description and analysis for any particular objection shall constitute a waiver of the right to a hearing on the objection. Three copies of all documents are to be submitted and are to be identified with the docket number found in brackets in the heading of this document. Any objections received in response to the regulation may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. List of Subjects in 21 CFR Part 573 Animal feeds, Food additives. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 573 is amended as follows: PART 573—FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS 1. The authority citation for 21 CFR part 573 continues to read as follows: Authority: 21 U.S.C. 321, 342, 348. 2. Section 573.920 is amended by revising paragraph

(h)to read as follows: § 573.920 Selenium.

(h)Selenium yeast is a dried, non-viable yeast ( *Saccharomyces cerevisiae* ) cultivated in a fed-batch fermentation which provides incremental amounts of cane molasses and selenium salts in a manner which minimizes the detrimental effects of selenium salts on the growth rate of the yeast and allows for optimal incorporation of inorganic selenium into cellular organic material. Residual inorganic selenium is eliminated in a rigorous washing process and must not exceed 2 percent of the total selenium content in the final selenium yeast product.

(1)Selenium, as selenium yeast, is added to feed as follows:

(i)In complete feed for chickens, turkeys, swine, beef cattle, and dairy cattle at a level not to exceed 0.3 part per million.

(ii)In feed supplements for limit feeding for beef cattle at a level not to exceed an intake of 3 milligrams per head per day.

(iii)In salt-mineral mixtures for free-choice feeding for beef cattle up to 120 parts per million in a mixture for free-choice feeding at a rate not to exceed an intake of 3 milligrams per head per day.

(2)Guaranteed organic selenium content from selenium yeast must be declared on the selenium yeast product label.

(3)The additive, as selenium yeast, shall be incorporated into feed as follows:

(i)It shall be incorporated into each ton of complete feed by adding no less than 1 pound of a premix containing no more than 272.4 milligrams of added selenium per pound.

(ii)It shall be incorporated into each ton of salt-mineral mixture for beef cattle from a premix containing no more than 4.5 grams of added selenium per pound.

(4)Usage of this additive must conform to the requirements of paragraphs

(e)and

(f)of this section. Dated: July 6, 2007. Stephen F. Sundlof, Director, Center for Veterinary Medicine. [FR Doc. E7-13954 Filed 7-18-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF DEFENSE DEPARTMENT OF HOMELAND SECURITY Coast Guard DEPARTMENT OF VETERANS AFFAIRS 38 CFR Part 21 RIN 2900-AM50 Increase in Rates Payable Under the Montgomery GI Bill—Selected Reserve and Other Miscellaneous Issues AGENCIES: Department of Defense, Department of Homeland Security (United States Coast Guard), and Department of Veterans Affairs. ACTION: Final rule. SUMMARY: This document amends Department of Veterans Affairs

(VA)regulations to increase the monthly rates of basic educational assistance payable under the Montgomery GI Bill—Selected Reserve (MGIB-SR) program for fiscal years 2005 and 2006 in accordance with statutory requirements, increase the percentage of basic educational assistance payable to reservists pursuing apprenticeship or other on-the-job training in accordance with the Veterans Benefits Act of 2004, and remove obsolete education break-pay provisions. DATES: *Effective Date:* This final rule is effective July 19, 2007. *Applicability Dates:* The changes in the MGIB-SR rates for fiscal years 2005 and 2006 are applied retroactively to October 1, 2004, and October 1, 2005, respectively to conform to statutory requirements. The change in the percentage of basic educational assistance payable to reservists pursuing apprenticeship or other on-the-job training is applied retroactively to October 1, 2005, to conform to statutory requirements. The changes in the break-pay regulations contained in 38 CFR 21.7640 are effective July 19, 2007. FOR FURTHER INFORMATION CONTACT: Brandye R. Kidd, Management and Program Analyst, Education Service (225C), Veterans Benefits Administration, Department of Veterans Affairs, 810 Vermont Avenue, NW., Washington, DC 20420, telephone

(202)273-7420. (This is not a toll-free number.) SUPPLEMENTARY INFORMATION: I. Increase in MGIB-SR Monthly Rates Under the formula mandated by 10 U.S.C. 16131(b), the rates of basic educational assistance under the MGIB-SR payable to students pursuing a program of education full-time, three-quarter-time, and half-time must be increased by the percentage by which the total monthly Consumer Price Index-W for the 12-month period ending on June 30 preceding the fiscal year during which the increase is applicable exceeds the Consumer Price Index-W for the 12-month period ending on June 30 the previous fiscal year. Using this formula, VA calculated a 2 percent increase for fiscal year 2005 and a 3 percent increase for fiscal year 2006. Section 16131(b) also requires that VA pay reservists, who are pursuing a program of education at less than half-time, an appropriately reduced rate. Since payment for less than half-time educational programs became available under the MGIB-SR in fiscal year 1990, VA has paid less than half-time students at 25 percent of the full-time rate. In this rule, VA continues that practice and will pay eligible reservists 25 percent of the increased full-time rate described above. Section 16131(d) requires that reservists pursuing a full-time program of apprenticeship or other on-the-job training be paid a percentage of the basic educational monthly rate. Benefits for the first 6 months of training, the second 6 months of training, and the remainder of the program, are payable at 75 percent, 55 percent, and 35 percent respectively. Based on the section 16131(b) formula described above, there is a 2 percent increase for the apprenticeship and other on-the-job training pursued during fiscal year 2005 and a 3 percent increase for training during fiscal year 2006. The increase in the MGIB-SR rates are applied in accordance with the applicable statutory provisions discussed above. Thus, VA began paying the 2005 and 2006 fiscal year increases effective October 1, 2004 and October 1, 2005 respectively. II. Increase in the Percentage of Basic Educational Assistance Payable to Reservists Pursuing Apprenticeship or Other On-the-Job Training The Veterans Benefits Improvement Act of 2004, Public Law 108-454, temporarily increased the percentages payable for apprenticeship and other on-the-job training from 75 percent, 55 percent, and 35 percent, to 85 percent, 65 percent, and 45 percent of the full-time rate of basic educational assistance, respectively, after September 30, 2005, and before January 1, 2008. VA began paying the increased rates for reservists pursuing apprenticeship or other on-the-job training effective October 1, 2005, in accordance with Public Law 108-454. III. Changes to Education Break-Pay Regulations Including the Removal of Obsolete Provisions We are amending 38 CFR 21.7640(b) to remove obsolete provisions and provide greater clarity of regulations regarding benefit payments for school break periods between terms. In 2003, 38 CFR 21.4138(f), governing payment for breaks between terms, quarters or semesters, was amended to conform to statutory requirements. The final rule was published June 9, 2003, in the **Federal Register** (68 FR 34327-34332). The preamble to that final rule states that changes made to § 21.4138(f) are applicable to the Montgomery GI Bill—Active Duty, Survivors' and Dependents' Educational Assistance Program, Veterans Educational Assistance Program, and MGIB-SR. Although we amended the language in § 21.4138(f) in that final rule, we neglected to make a conforming amendment to § 21.7640(b) regarding payment for breaks, including intervals between terms. This document amends the language in the aforementioned section in accordance with statutory requirements and the previously published rule. The changes to the break-pay regulations, including the removal of obsolete provisions, are effective from July 19, 2007. Administrative Procedure Act Changes to 38 CFR part 21 are being published without regard to the notice-and-comment and delayed-effective-date provisions of 5 U.S.C. 553 since they merely conform VA's existing rules to the statutory requirements. Accordingly, these changes involve interpretive rules that are exempt from the notice-and-comment and delayed-effective-date requirement of 5 U.S.C. 553(b) and (d). Executive Order 12866 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 Executive Order classifies a “significant regulatory action,” requiring review by the Office of Management and Budget

(OMB)unless OMB waives such review, as any regulatory action that is likely to result in a rule that may:

(1)Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities;

(2)create a serious inconsistency or otherwise interfere with an action taken or planned by another agency;

(3)materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or

(4)raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order. The economic, interagency, budgetary, legal, and policy implications of this final rule have been examined and it has been determined not to be a significant regulatory action under Executive Order 12866. Paperwork Reduction Act This document contains no provisions constituting a collection of information under the Paperwork Reduction Act (44 U.S.C. 3501-3521). Regulatory Flexibility Act The initial and final regulatory flexibility analyses requirements of sections 603 and 604 of the Regulatory Flexibility Act, 5 U.S.C. 601-612, are not applicable to this rule, because a notice of proposed rulemaking is not required for this rule. Even so, the Secretary of Veterans Affairs hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act. This final rule directly affects only individuals and does not directly affect small entities. Therefore, this final rule is also exempt pursuant to 5 U.S.C. 605(b) from the initial and final regulatory flexibility analyses requirements of sections 603 and 604. Unfunded Mandates The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any given year. This final rule would have no such effect on State, local, and tribal governments, or on the private sector. Catalog of Federal Domestic Assistance There is no Catalog of Federal Domestic Assistance number for the program affected by this final rule. List of Subjects in 38 CFR Part 21 Administrative practice and procedure, Armed forces, Civil rights, Claims, Colleges and universities, Conflict of interests, Education, Employment, Grant programs—education, Grant programs—veterans, Health care, Loan programs—education, Loan programs—veterans, Manpower training programs, Reporting and recordkeeping requirements, Schools, Travel and transportation expenses, Veterans, Vocational education, Vocational rehabilitation. Approved: February 9, 2007. Gordon H. Mansfield, Deputy Secretary of Veterans Affairs. Approved: March 12, 2007. Clifford L. Pearson, Rear Admiral, U.S. Coast Guard, Assistant Commandant for Human Resources. Approved: May 7, 2007. T.F. Hall, Assistant Secretary of Defense for Reserve Affairs. For the reasons stated above, VA amends 38 CFR part 21, subpart L, as set forth below. PART 21—VOCATIONAL REHABILITATION AND EDUCATION Subpart L—Educational Assistance for Members of the Selected Reserve 1. Revise the authority citation for part 21, subpart L, to read as follows: Authority: 10 U.S.C. ch. 1606; 38 U.S.C. 501(a), 512, ch. 36, and as stated in specific sections. 2. Amend § 21.7635(c)(3) by removing “§ 21.7640” and adding, in its place, “§ 21.4138(f)”. 3. Amend § 21.7636 by revising paragraphs (a)(1), (a)(2)(i), and (a)(3) to read as follows: § 21.7636 Rates of payment.

(a)*Monthly rate of educational assistance.*

(1)Except as otherwise provided in this section or in § 21.7639, basic educational assistance is payable at the following monthly rates.

(i)For training that occurs after September 30, 2004, and before October 1, 2005: Training Monthly rate Full time $288.00 3/4 time 216.00 1/2 time 143.00 1/4 time 72.00

(ii)For training that occurs after September 30, 2005: Training Monthly rate Full time $297.00 3/4 time 222.00 1/2 time 147.00 1/4 time 74.25 (2)(i) The monthly rate of basic educational assistance payable to a reservist for apprenticeship or other on-the-job training full time is payable at the following rates.

(A)For training which occurs after September 30, 2004, and before October 1, 2005: Training Monthly rate First 6 months of pursuit of training $216.00 Second 6 months of pursuit of training 158.40 Remaining pursuit of training 100.80

(B)For training which occurs after September 30, 2005: Training Monthly rate First 6 months of pursuit of training $252.45 Second 6 months of pursuit of training 193.05 Remaining pursuit of training 133.65

(ii)* * *

(3)The monthly rate of basic educational assistance payable to a reservist for pursuit of a cooperative course is as follows:

(i)For full-time training that occurs after September 30, 2004, and before October 1, 2005, the rate payable is the rate stated in paragraph (a)(1)(i) of this section.

(ii)For full-time training that occurs after September 30, 2005, the rate payable is the rate stated in paragraph (a)(1)(ii) of this section. 4. Amend § 21.7640 by revising paragraph

(b)to read as follows: § 21.7640 Release of payments.

(b)*Payment for breaks, including intervals between terms.* In administering 10 U.S.C. chapter 1606, VA will apply the provisions of § 21.4138(f) when determining whether a reservist is entitled to payment for a break, including an interval between terms. (Authority: 10 U.S.C. 16136(b), 38 U.S.C. 3680) [FR Doc. 07-3466 Filed 7-18-07; 8:45 am]

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