The Organic Foods Production Act of 1990 (OFPA), as amended, (7 U.S.C. 6501 et seq. ), authorizes the establishment of the NOP regulations. On December 21, 2000, the Secretary established, within the NOP (7 CFR part 205), the National List regulations §§ 205.600 through 205.607. This National List identifies the synthetic substances that may be used and the non-synthetic substances that may not be used in organic production. The National List also identifies synthetic, non-synthetic non-agricultural and non-organic agricultural substances that may be used in organic handling. The OFPA and NOP regulations, in § 205.105, specifically prohibit the use of any synthetic substance for organic production and handling unless the synthetic substance is on the National List. Section 205.105 also requires that any non-organic agricultural, non-synthetic non-agricultural substance used in organic handling must also be on the National List.

Until recently, some producers, handlers and certifying agents have misinterpreted National List regulations § 205.606 to mean that any non-organic agricultural product which was determined by an accredited certifying agent to be not commercially available in organic form could be used in organic products, without being individually listed pursuant to the National List procedures. In January 2005, the First Circuit Court of Appeal's decision in Harvey v. Johanns found that such an interpretation is contrary to the plain meaning of the OFPA and held that 7 CFR 205.606 shall not be interpreted to create a blanket exemption to the National List requirements specified in §§ 6517 and 6518 of the OFPA (7 U.S.C. 6517-6518). Therefore, consistent with the district court's final judgment and order, dated June 9, 2005, on July 1, 2005, the NOP published a notice regarding § 205.606 (70 FR 38090), and on June 7, 2006, published a final rule (71 FR 32803) revising § 205.606 to clarify that the section shall be interpreted to permit the use of a non-organically produced agricultural product only when the product has been listed in § 205.606, and when an accredited certifying agent has determined that the organic form of the agricultural product is not commercially available. In order to enable an orderly transition, the district court's final judgment and order allowed for products produced in conformance with the misinterpretation of § 205.606 to be produced and sold until June 9, 2007, after which point no non-conforming products may enter the stream of commerce. As a result, since June 9, 2007, any certified products that have been produced and entered into the stream of commerce using non-organic agricultural ingredients that are not listed in § 205.606 are in non-compliance with the district court's final order and judgment on Harvey v. Johanns .

Concerning organic products that contain no more than 5% non-organic agricultural ingredients that do not appear on the National List, such products that have been produced and labeled as organic prior to June 9, 2007, are considered to be in the stream of commerce. “Organic” products that meet this description may remain in the marketplace as organically produced until the existing supply is exhausted.

On May 15, 2007, USDA published a proposed rule (72 FR 27252) to amend the National List regulations to enact recommendations submitted to the Secretary by the NOSB as a result of public meetings held on May 6-8, 2002, in Austin, TX, and March 27-29, 2007, in Washington, DC. This proposed rule suggested the addition of 38 non-organic agricultural ingredients, along with any restrictive annotations, to the National List regulations. The 38 ingredients proposed for addition to the National List were based on petitions from the industry, in response to the potential impact of the district court's final order and judgment concerning changes to § 205.606 of the NOP regulations.

NOP and NOSB received approximately 99 petitions to add more than 600 non-organic agricultural ingredients and substances to § 205.606 of the National List regulations. After Program review for adequate petition information, 79 petitions to add 52 substances to the National List were forwarded through the petition review process to the NOSB Materials and Handling Committees for review and evaluation against the OFPA criteria and NOP regulations. Prior to the respective public NOSB meetings, 52 draft recommendations from the NOSB committees were posted on the NOP Web site for review and public comment. Of the 52 petitioned ingredients, the NOSB, for their March 2007 meeting, requested, received, and reviewed public comments on the petitioned ingredients and voted to add 38 ingredients to § 205.606 of the National List.

Under the authority of OFPA and the NOP regulations, the National List can be amended by the Secretary based upon recommendations by the NOSB.

The following provides an overview of the amendments to designated sections of the National List regulations.

This interim final rule amends § 205.606 of the National List regulations by adding the following substances:

Annatto extract color (pigment CAS # 1393-63-1)—water and oil soluble.

Beet juice extract color (pigment CAS # 7659-95-2).

Beta-Carotene extract color from carrots (CAS # 1393-63-1).

Black currant juice color (pigment CAS #'s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-04-3).

Black/Purple carrot juice color (pigment CAS #'s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-04-3).

Blueberry juice color (pigment CAS #'s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-04-3).

Carrot juice color (pigment CAS # 1393-63-1).

Cherry juice color (pigment CAS #'s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-04-3).

Chokeberry—Aronia juice color (pigment CAS #'s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-04-3).

Elderberry juice color (pigment CAS #'s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-04-3).

Grape juice color (pigment CAS #'s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-04-3).

Grape skin extract color (pigment CAS #'s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-04-3).

Paprika color—dried powder and vegetable oil extract (CAS # 68917-78-2).

Pumpkin juice color (pigment CAS # 127-40-2).

Purple potato juice color (pigment CAS #'s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-04-3).

Red cabbage extract color (pigment CAS #'s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-04-3).

Red radish extract color (pigment CAS #'s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-04-3).

Saffron extract color (pigment CAS # 1393-63-1).

Turmeric extract color (CAS # 458-37-7).

Casings, from processed intestines (no CAS #).

Celery powder (No CAS #).

Chia ( Salvia hispanica L. ) (no CAS #).

Dillweed oil (CAS # 8006-75-5).

Fish oil (Fatty acid CAS #'s: 10417-94-4, and 25167-62-8).

Fructooligosaccharides (CAS # 308066-66-2).

Galangal, frozen (no CAS #).

Gelatin (CAS # 9000-70-8).

Hops ( Humulus lupulus ) (no CAS #).

Inulin, oligofructose enriched (CAS # 9005-80-5).

Konjac flour (CAS # 37220-17-0).

Lemongrass, frozen (no CAS #).

Orange shellac, unbleached (CAS # 9000-59-3).

Pepper, chipotle chile (no CAS #).

Rice starch, unmodified (CAS # 977000-08-0)—for use in organic handling until [two years from date of publication].

Sweet potato starch, for bean thread production only (no CAS #).

Turkish bay leaves (no CAS #).

Wakame seaweed ( Undaria pinnatifida ) (no CAS #).

Whey protein concentrate (no CAS #).

Two notices and one proposed rule (72 FR 27252) were published regarding the meetings of the NOSB and its deliberations on recommendations and substances petitioned for amending the National List. Substances and recommendations included in this interim final rule were announced for NOSB deliberation in the following Federal Register Notices: (1) 67 FR 19375, April 19, 2002, (Gelatin, Konjac flour, Orange shellac); (2) 72 FR 10971, March 12, 2007, (Casings, Celery powder, Chia ( Salvia hispanica L. ), Colors—from agricultural products: Annatto extract; Beet juice; Beta-carotene extract; Purple carrot juice; Black currant juice; Blueberry juice; Carrot juice; Cherry juice; Chokeberry/Aronia juice; Elderberry juice; Grape juice; Grape skin extract; Paprika; Pumpkin juice; Purple potato juice; Red cabbage extract; Red radish extract; Saffron; Turmeric; Dillweed oil, Fish oil, Fructooligosaccharides, Galangal—frozen, Hops, Inulin—oligofructose enriched, Lemongrass—frozen, Pepper—chipotle chile, Rice starch, Sweet potato starch, Turkish bay leaves, Wakame seaweed ( Undaria pinnatifida ), and Whey protein concentrate).

The OFPA, as amended (7 U.S.C. 6501 et seq. ), authorizes the Secretary to make amendments to the National List based on recommendations by the NOSB. Sections 6518(k)(2) and 6518(n) of OFPA authorize the NOSB to recommend changes to the National List for submission to the Secretary and establish a petition process by which persons may petition the NOSB for the purpose of having substances evaluated for inclusion on or deletion from the National List. The National List petition process is implemented under § 205.607 of the NOP regulations. The current petition process (72 FR 2167 January 18, 2007) can be accessed through the NOP Web site at http://www.ams.usda.gov/nop .

This action has been determined not significant for purposes of Executive Order 12866, and therefore, has not been reviewed by the Office of Management and Budget.

Executive Order 12988 instructs each executive agency to adhere to certain requirements in the development of new and revised regulations in order to avoid unduly burdening the court system. This interim final rule is not intended to have a retroactive effect.

States and local jurisdictions are preempted under the OFPA from creating programs of accreditation for private persons or State officials who want to become certifying agents of organic farms or handling operations. A governing State official would have to apply to USDA to be accredited as a certifying agent, as described in § 6514(b) of the OFPA (7 U.S.C. 6514(b)). States are also preempted under §§ 6503 through 6507 of the OFPA (7 U.S.C. 6503 through 6507) from creating certification programs to certify organic farms or handling operations unless the State programs have been submitted to, and approved by, the Secretary as meeting the requirements of the OFPA.

Pursuant to § 6507(b)(2) of the OFPA (7 U.S.C. 6507(b)(2)), a State organic certification program may contain additional requirements for the production and handling of organically produced agricultural products that are produced in the State and for the certification of organic farm and handling operations located within the State under certain circumstances. Such additional requirements must: (a) Further the purposes of the OFPA, (b) not be inconsistent with the OFPA, (c) not be discriminatory toward agricultural commodities organically produced in other States, and (d) not be effective until approved by the Secretary.

Pursuant to § 6519(f) of the OFPA (7 U.S.C. 6519(f)), this interim final rule would not alter the authority of the Secretary under the Federal Meat Inspection Act (21 U.S.C. 601 et seq. ), the Poultry Products Inspections Act (21 U.S.C. 451 et seq. ), or the Egg Products Inspection Act (21 U.S.C. 1031 et seq. ), concerning meat, poultry, and egg products, nor any of the authorities of the Secretary of Health and Human Services under the Federal Food, Drug and Cosmetic Act (21 U.S.C. 301 et seq. ), nor the authority of the Administrator of the Environmental Protection Agency (EPA) under the Federal Insecticide, Fungicide and Rodenticide Act (7 U.S.C. 136 et seq. ).

Section 6520 of the OFPA (7 U.S.C. 6520) provides for the Secretary to establish an expedited administrative appeals procedure under which persons may appeal an action of the Secretary, the applicable governing State official, or a certifying agent under this title that adversely affects such person or is inconsistent with the organic certification program established under this title. The OFPA also provides that the U.S. District Court for the district in which a person is located has jurisdiction to review the Secretary's decision.

The Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ) requires agencies to consider the economic impact of each rule on small entities and evaluate alternatives that would accomplish the objectives of the rule without unduly burdening small entities or erecting barriers that would restrict their ability to compete in the market. The purpose is to fit regulatory actions to the scale of businesses subject to the action. Section 605 of the RFA allows an agency to certify a rule, in lieu of preparing an analysis, if the rulemaking is not expected to have a significant economic impact on a substantial number of small entities.

Pursuant to the requirements set forth in the RFA, the Agricultural Marketing Service (AMS) performed an economic impact analysis on small entities in the final rule published in the Federal Register on December 21, 2000 (65 FR 80548). The AMS has also considered the economic impact of this action on small entities. The impact on entities affected by this interim final rule would not be significant. The effect of this interim final rule would be to allow the use of additional substances in agricultural production and handling. This action would modify the regulations to provide both large and small entities with more tools to use in day-to-day operations. The AMS concludes that the economic impact of this addition of allowed substances, if any, would be minimal and entirely beneficial to both large and small agricultural service firms. Accordingly, AMS certifies that this interim final rule will not have a significant economic impact on a substantial number of small entities. AMS invites comments on the economic impact on small entities of this interim final rule.

Small agricultural service firms, which include producers, handlers, and accredited certifying agents, have been defined by the Small Business Administration (SBA) (13 CFR 121.201) as those having annual receipts of less than $6,500,000 and small agricultural producers are defined as those having annual receipts of less than $750,000. This interim final rule would have an impact on a substantial number of small entities.

Based upon USDA's Economic Research Service and AMS data compiled from 2001 to 2005, the U.S. organic industry at the end of 2005 included nearly 8,500 certified organic crop and livestock operations, plus more than 2,900 handling operations. Organic crop and livestock operations reported certified acreage totaling more than 4.05 million acres of organic farm production. Total number of organic crop and livestock operations increased by more than 18 percent from 2001 to 2005, while total certified acreage more than doubled during this time period. AMS estimates that these trends continued through 2006 and will be higher in 2007.

U.S. sales of organic food and beverages have grown from $1 billion in 1990 to nearly $17 billion in 2006. Organic food sales are projected to reach $23.8 billion for 2010. The organic industry is viewed as the fastest growing sector of agriculture, currently representing nearly 3 percent of overall food and beverage sales. Since 1990, organic retail sales have historically demonstrated a growth rate between 20 to 24 percent each year including a 22 percent increase in 2006.

In addition, USDA has accredited 99 certifying agents who have applied to USDA to be accredited in order to provide certification services to producers and handlers. A complete list of names and addresses of accredited certifying agents may be found on the NOP Web site, at http://www.ams.usda.gov/nop . AMS believes that most of these entities would be considered small entities under the criteria established by the SBA.

Under the OFPA, no additional collection or recordkeeping requirements are imposed on the public by this interim final rule. Accordingly, OMB clearance is not required by section 350(h) of the Paperwork Reduction Act of 1995, 44 U.S.C. 3501, et seq. , or OMB's implementing regulation at 5 CFR part 1320.

AMS is committed to compliance with the Government Paperwork Elimination Act (GPEA), which requires Government agencies in general to provide the public the option of submitting information or transacting business electronically to the maximum extent possible.

AMS received approximately 1,250 comments on proposed rule AMS-TM-07-0062. Comments were received from organic producers and handlers, accredited certifying agents, consumers, retailers, food service establishments and public interest groups. In general, comments were opposed to the abbreviated comment period for proposed rule AMS-TM-07-0062 and requested an extended comment period. There were comments that supported the addition of all 38 non-organic agricultural ingredients to the National List; while other comments opposed the addition of all non-organic agricultural ingredients to § 205.606 of the National List.

Many comments either supported or opposed the specific National List amendments of the following non-organic agricultural ingredients: Casings from processed intestines; gelatin; colors from agricultural products; konjac flour; hops; lemongrass; Turkish bay leaves; turmeric; and whey protein concentrate. Some comments addressed the inclusion of CAS numbers or the use of scientific names to identify the non-organic ingredients.

Though a significant number of comments were received, very few comments submitted were from processors or handlers. Comments from this segment of the industry would be helpful in developing a final rule. A number of comments expressed concern regarding the information and criteria used for determining the fragility of the organic ingredient supply or organic availability of the proposed 38 non-organic agricultural ingredients.

As a result of the district court's final order and judgment in Harvey v. Johanns and requests for an extension of the public comment period on AMS-TM-07-0062, AMS is issuing this interim final rule to (1) Permit the use of the 38 ingredients during the extended comment and final rulemaking periods to minimize the impact to the organic industry and (2) extend the comment period (60 days) to receive additional comments regarding the addition of the 38 non-organic agricultural ingredients to § 205.606.

Effective June 9, 2007, these 38 substances were prohibited for use in processed products labeled as “organic.” Continued loss of the use of these products would disrupt the trade of food products currently being labeled as “organic”. Therefore, the continued use of these products as ingredients in foods labeled as “organic” is necessary to prevent possible significant business disruption for organic producers and handlers. Accordingly, pursuant to 5 U.S.C. 553, it is found, and determined, upon good cause, that it is impracticable, unnecessary, and contrary to the public interest to give further notice prior to putting this rule into effect, and that good cause exists for not postponing the effective date of this interim final rule until 30 days after publication in the Federal Register .

Marketing Order No. 948, as amended (7 CFR part 948), regulates the handling of Irish potatoes grown in Colorado, hereinafter referred to as the “order.” The order is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.”

The State of Colorado is divided into three areas for marketing order purposes. Currently, only Area No. 2 and Area No. 3 are active.

Area No. 1, commonly known as the Western Slope, includes and consists of the counties of Routt, Eagle, Pitkin, Gunnison, Hinsdale, La Plata, in the State of Colorado, and all counties in said State west of the aforesaid counties.

Area No. 2, commonly known as the San Luis Valley, includes and consists of the counties of Chaffee, Saguache, Huerfano, Las Animas, Mineral, Archuleta, Rio Grande, Conejos, Costilla, and Alamosa in the State of Colorado.

Area No. 3, commonly known as Northern Colorado, includes and consists of all the remaining counties in the State of Colorado which are not included in Area No. 1 or Area No. 2.

The order establishes administrative committees for each of these areas (area committees).

The Area No. 2 administrative committee is comprised of 14 members and their respective alternates. Nine members represent producers and five members represent handlers. Two producers are from Rio Grande County, two producers are from either Saguache County or Chaffee County, one producer is from Conejos County, two producers are from Alamosa County, one producer represents all other counties in Area No. 2, and one producer represents certified seed producers in Area No. 2. Two handlers represent bulk handlers in Area No. 2 and three handlers represent handlers in Area No. 2 other than bulk handlers.

The Area No. 3 administrative committee is comprised of five members and their respective alternates. Three producers and two handlers represent producers and handlers from any county in Area No. 3.

With regulations in Area No. 1 suspended, there is currently no need for an Area No. 1 administrative committee.

The order also establishes the Colorado Potato Committee (CPC) which is comprised of six members and alternates selected by the Department of Agriculture (USDA). Three members and three alternates are selected from nominations of Area No. 2 committee members or alternates, and three members and three alternates are selected from nominations of Area No. 3 committee members or alternates.

Currently, there are approximately 175 producers and 95 handlers of Colorado potatoes in both of the active areas. The majority of producers and handlers may be classified as small entities. The regulations implemented under the order are applied uniformly and designed to benefit all entities, regardless of size.

AMS published in the Federal Register on February 18, 1999 (64 FR 8014), a plan to review certain regulations, including Marketing Order No. 948, under criteria contained in section 610 of the RFA (5 U.S.C. 601-612). Updated plans were published in the Federal Register on January 4, 2002 (67 FR 525), August 14, 2003 (68 FR 48574), and again on March 24, 2006 (71 FR 14827). Accordingly, AMS published a notice of review and request for written comments on the Colorado potato marketing order in the February 21, 2006, issue of the Federal Register (71 FR 8810). The deadline for comments ended April 24, 2006. Two comments were received in support of the order, and are discussed later in this document.

The review was undertaken to determine whether the Colorado potato marketing order should be continued without being changed, amended, or rescinded to minimize the impacts on small entities. In conducting this review, AMS considered the following factors: (1) The continued need for the order; (2) the nature of complaints or comments received from the public concerning the order; (3) the complexity of the order; (4) the extent to which the order overlaps, duplicates, or conflicts with other Federal rules, and, to the extent feasible, with State and local governmental rules; and (5) the length of time since the order has been evaluated or the degree to which technology, economic conditions, or other factors have changed in the area affected by the order.

The order authorizes grade, size, quality, maturity, pack, and container regulations as well as inspection requirements. The grade, size, quality, maturity, and inspection regulations are also applied to imported potatoes under section 608e of the Act. The order also authorizes the area committees to establish projects including marketing research and development projects, designed to assist, improve, or promote the marketing, distribution, and consumption of potatoes.

These order requirements have helped ensure that only quality product reaches the consumer. Quality requirements have helped increase and maintain demand for Colorado potatoes over the years. The compilation and dissemination of statistical information has helped producers and handlers make production and marketing decisions. Funds to administer the order are obtained from handler assessments.

Regarding complaints or comments received from the public concerning the order, USDA received two comments, one each from the Area No. 2 and Area No. 3 Committees. Both comments were in favor of the continuation of the order and addressed each of the five factors under consideration by AMS.

Marketing order issues and programs are discussed at public meetings, and all interested persons are allowed to express their views. All comments are considered in the decision making process by the area committees and the USDA before any program changes are implemented.

In considering the order's complexity, AMS has determined that the order is not unduly complex.

During the review, the order was also checked for duplication and overlap with other regulations. AMS did not identify any relevant Federal rules, or State and local regulations that duplicate, overlap, or conflict with the marketing order for Colorado potatoes. There is a Colorado State marketing order for potatoes authorized to conduct programs similar to those under the Federal order. However, the State program cooperates with the Federal order to ensure that their efforts are not duplicative. For instance, the State order currently conducts production and marketing research and market promotion, which are authorized—but not being conducted—under the Federal order.

The order was established in August 1941. During the 65 years the order has been effective, AMS and the Colorado potato industry have continuously monitored marketing operations. Changes in regulations have been implemented to reflect current industry operating practices, and to solve marketing problems as they occur. The goal of periodic evaluations is to assure that the order and the regulations implemented under it fit the needs of the industry and are consistent with the Act.

The CPC and both area committees meet several times a year to discuss the order and the various regulations issued thereunder, and to determine if, or what, changes may be necessary to reflect current industry practices. As a result, regulatory changes have been made numerous times over the years to address industry operation changes and to improve program administration. In addition, in 1960, the area committees made several recommendations to improve quality regulations and program operations through formal amendment of the order. An amendment hearing was subsequently held in Denver, Colorado, on February 1-2, 1960, to receive evidence regarding the recommendations. As a result, a referendum was held June 20-28, 1960, to determine producer support for the proposed amendments. The proposed amendments were favored by a majority of the producers voting in the referendum.

Based on the potential benefits of the order to producers, handlers, and consumers, AMS has determined that the Colorado potato marketing order should be continued. The order was established to help the Colorado potato industry work with USDA to solve marketing problems. The order regulations on grade, size, quality, maturity, pack, container, and marketing research and development activities continue to be beneficial to producers, handlers, and consumers. AMS will continue to work with the Colorado potato industry in maintaining an effective marketing order program.

This rule is issued under the Mushroom Promotion, Research, and Consumer Information Order [7 CFR part 1209]. The Order is authorized under the Mushroom Promotion, Research, and Consumer Information Act of 1990 (Act) [7 U.S.C. 6101-6112].

The Office of Management and Budget has waived the review process required by Executive Order 12866 for this action.

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. The rule is not intended to have a retroactive effect and will not affect or preempt any other State or Federal law authorizing promotion or research relating to an agricultural commodity.

The Act provides that any person subject to the Order may file a written petition with the Department of Agriculture (Department) if they believe that the Order, any provision of the Order, or any obligation imposed in connection with the Order, is not established in accordance with law. In any petition, the person may request a modification of the Order or an exemption from the Order. The petitioner is afforded the opportunity for a hearing on the petition. After a hearing, the Department would rule on the petition. The Act provides that the district court of the United States in any district in which the petitioner resides or conducts business shall have the jurisdiction to review the Department's ruling on the petition, provided a complaint is filed not later than 20 days after the date of the entry of the ruling.

In accordance with the Regulatory Flexibility Act (RFA) [5 U.S.C. 601 et seq. ], the Agricultural Marketing Service (AMS) has examined the economic impact of this rule on small entities. The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such action so that small businesses will not be unduly or disproportionately burdened.

The Small Business Administration defines, in 13 CFR part 121, small agricultural producers as those having annual receipts of no more than $750,000 and small agricultural service firms (importers) as having receipts of no more than $6,500,000. There are 97 producers and 18 importers subject to the Order, and thus, eligible to serve on the Council. The majority of these producers and importers are considered small entities as defined by the Small Business Administration. Producers and importers of 500,000 pounds or less of mushrooms for the fresh market are exempt from the Order.

The Order provides for the establishment of a Council consisting of at least four members and not more than nine members. For the purpose of nominating and appointing producers to the Council, the United States is divided into four geographic regions (Regions 1, 2, 3, and 4) with Council member representation allocated for each region based on the geographic distribution of mushroom production. For importers (referred to as Region 5), one Council member seat is allocated when imports, on average, exceed 35,000,000 pounds of mushrooms annually. The Order also specifies that the Council will review—at least every five years and not more than every three years—the geographic distribution of United States mushroom production volume and import volume, and recommend changes accordingly.

At its June 2006 meeting, the Council reviewed mushroom production volume in the United States and import volume for the July 1, 2002, through June 30, 2005, yearly periods. Based on the data, the Council reviewed and discussed reapportionment proposals. After considerable discussion, the Council approved a reapportionment proposal for recommendation to the Department. The Council recommended reapportionment of the Order's four United States geographic regions, and the reallocation of Council member representation in two of the four United States regions (Regions 1 and 4) to reflect shifts in United States mushroom production.

This rule adopts the interim final rule that realigns the four United States geographic regions, and reallocates Council member representation in two of the four United States geographic regions as follows: Region 1—the States of Colorado, Oklahoma, Wyoming, Washington, Oregon, Florida, Illinois, Tennessee, Texas and Utah; Region 2—the State of Pennsylvania; Region 3—the State of California; and Region 4—all other States including the District of Columbia and the Commonwealth of Puerto Rico. Also, the number of Council member representation is reallocated as follows: from one member to three members for Region 1 and from two members to zero members for Region 4. Representation for Region 2, Region 3, and importers remains unchanged at three members, two members, and one member respectively.

The overall impact is favorable for producers and importers because the producers and importers will have more equitable representation on the Council based on United States mushroom production volume and import volume.

In accordance with the Office of Management and Budget (OMB) regulation [5 CFR Part 1320] which implements the Paperwork Reduction Act of 1995 (PRA) [44 U.S.C. Chapter 35], the information collection requirements under the PRA, there are no new requirements contained in this rule. The information collection requirements have been previously approved by the Office of Management and Budget (OMB) under OMB control number 0581-0093. This rule does not result in a change to the information collection and recordkeeping requirements previously approved. In terms of alternatives to this rule, this action reflects the volume thresholds and procedures that have been established previously under the provisions of the Order for reallocation of Council membership.

There are no Federal rules that duplicate, overlap, or conflict with this rule.

The Order is authorized under the Mushroom Promotion, Research, and Consumer Information Act of 1990 [7 U.S.C. 6101-6112], and is administered by the Council. Under the Order, the Council administers a nationally coordinated program of research, development, and information designed to strengthen the fresh mushroom's position in the market place and to establish, maintain, and expand markets for fresh mushrooms. The program is financed by an assessment of $0.0043 cents per pound on any person who produces or imports over 500,000 pounds of mushrooms for the fresh market annually. Under the Order, handlers collect and remit producer assessments to the Council, and assessments paid by importers are collected and remitted by the United States Customs Service.

The Order provides for the establishment of a Council consisting of at least four members and not more than nine members. For the purpose of nominating and appointing producers to the Council, the United States is divided into four geographic regions (Regions 1, 2, 3, and 4) with Council member representation allocated for each region based on the geographic distribution of mushroom production. For importers (referred to as Region 5), one Council member seat is allocated when imports, on average, exceed 35,000,000 pounds of mushrooms annually.

Section 1209.30(d) of the Order provides that at least every five years and not more than every three years, the Council shall review changes in the geographic distribution of mushroom production volume throughout the United States and import volume, using the average annual mushroom production and imports over the preceding four years. Based on the review, the Council is required to recommend reapportionment of the regions or modification of the number of members from such regions, or both, to reflect shifts in the geographic distribution of mushroom production volume and importer representation.

The Order provides that each producer region that produces, on average, at least 35 million pounds of mushrooms annually is entitled to one member. Further, each producer region is entitled to an additional member for each 50 million pounds of annual production, on average, in excess of the initial 35 million pounds required to qualify for representation, until the nine seats on the Council are filled. For purposes of this rule and as provided under the Order, “on average” reflects a rolling average of production or imports during the last three fiscal years.

Under the current Order, regions and Council member representation for each region are the following: Region 1: Colorado, Connecticut, Illinois, Indiana, Iowa, Kansas, Kentucky, Maine, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, New York, New Hampshire, North Dakota, Ohio, Rhode Island, South Dakota, Vermont, Wisconsin, and Wyoming—1 producer member; Region 2: Delaware, Maryland, New Jersey, Pennsylvania, the District of Columbia, West Virginia, and Virginia—3 producer members; Region 3: Alaska, Arizona, California, Hawaii, Idaho, Nevada, Oregon, Utah, and Washington—2 producer members; Region 4: Alabama, Arkansas, Florida, Georgia, Louisiana, Mississippi, New Mexico, North Carolina, Oklahoma, the Commonwealth of Puerto Rico, South Carolina, Tennessee, and Texas—2 producer members; and Region 5: importers; 1 member. Based on data for July 1, 2002, through June 30, 2005, there are about 725 million pounds of mushrooms assessed on average annually under the Order. Currently, the Order's Regions 1, 2, 3, 4, and 5 represent 32 million pounds, 382 million pounds, 133 million pounds, 113 million pounds, and 65 million pounds, respectively. Since Region 1 represents 32 million pounds of mushroom production, the region no longer qualifies for member representation because production within the region falls below the 35 million pounds Order requirement.

Based on data for the July 1, 2002, through June 30, 2005, the Order is revised to reapportion membership of the Council to reflect shifts in the geographic distribution of mushroom production. The annual average production of mushrooms for the Order's Regions 1, 2, 3, 4, and 5 as adopted in this rule will be 168 million pounds, 382 million pounds, 109 million pounds, 0 million pounds, and 65 million pounds. As adopted in this rule, Regions 1, 2, and 3 will be comprised of states with mushroom production, and Region 4 will be comprised of all other states with no mushroom production.

Based on a review of United States mushroom production volume and import volume, this rule adopts amendments to change the four United States geographic regions as follows: Region 1—the States of Colorado, Oklahoma, Wyoming, Washington, Oregon, Florida, Illinois, Tennessee, Texas and Utah; Region 2—the State of Pennsylvania; Region 3—the State of California; and Region 4—all other States including the District of Columbia and the Commonwealth of Puerto Rico. Also, the amendments changes the number of Council member representatives from one member to three members for Region 1 and from two members to zero members for Region 4. Representation for Region 2, Region 3, and importers remain unchanged at three members, two members, and one member, respectively. The amendments, which represent shifts in mushroom production volume, provides more equitable producer and importer representation on the Council based on U. S. mushroom production volumes and import volumes.

Nominations and appointments to the Council are conducted pursuant to §§ 1209.30 and 1209.230. Nominations for Council positions for terms of office that begin January 1, 2008 will be based on the amendments contained in this rule.

An interim final rule that reapportions the four United States geographic regions, and reallocates Council member representation under the Order was published in the Federal Register on March 19, 2007 [72 FR 12701]. The interim final rule provided for a 30-day comment period, which ended on April 18, 2007. One comment was received from the Council supporting the change.

After consideration of all relevant material presented, including the Board's recommendation and other information, the interim final rule as published in the Federal Register (72 FR 12701, March 19, 2007) is adopted, as a final rule, without change.

In September 2000, when part 70 was amended, a new Subpart H to part 70 was added which resulted in former § 70.61 being redesignated as § 70.81 and former § 70.62 being redesignated as § 70.82. Additionally, former § 70.71 was redesignated as § 70.91. NRC is amending its regulations to make conforming changes to citations in the regulatory text by replacing § 70.61 with § 70.81, replacing § 70.62 with § 70.82, and replacing § 70.71 with § 70.91, to update and correct cross-references within 10 CFR part 70. In addition, in September 2000, § 70.14 was redesignated as § 70.17 as referenced in § 70.51.

Because these amendments deal solely with correcting cross references in the regulations, the notice and comment provisions of the Administrative Procedure Act do not apply, under 5 U.S.C. 553(b)(B), because good cause exists to make these ministerial changes without unnecessary notices and public procedure. This amendment will become effective upon publication in the Federal Register . Good cause exists to dispense with the usual 30-day delay in the effective date, under 5 U.S.C. 553(d)(3), because this amendment is of a minor and administrative nature.

The NRC has determined that this final rule is the type of action described in categorical exclusion 10 CFR 51.22(c)(2). Therefore, neither an environmental impact statement nor an environmental assessment has been prepared for this final rule.

This final rule does not contain new or amended information collection requirements subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ). Existing requirements were approved by the Office of Management and Budget (OMB), approval numbers 3150-0009, 3150-0028, and 3150-0056.

The NRC may not conduct or sponsor, and a person is not required to respond to, a request for information or an information collection requirement unless the requesting document displays a currently valid OMB control number.

A regulatory analysis has not been prepared for this final rule, because this rule is administrative, in that it amends the regulations to reflect administrative conforming changes made to 10 CFR part 70. This is considered a minor non-substantive amendment and will not have a significant impact on NRC licensees or the public.

The NRC has determined that the backfit rule (§§ 50.109, 70.76, 72.62, or 76.76) does not apply to this final rule because this amendment does not involve any provisions that would impose backfits as defined in the backfit rule. This amendment is considered a minor non-substantive amendment; therefore, a backfit analysis is not required.

On July 20, 2006, OTS published a notice of proposed rulemaking (NPR) that proposed changes to the OTS mutual-to-stock conversion regulations, 12 CFR Part 563b (Conversion Regulations), and the OTS mutual holding company regulations, 12 CFR Part 575 (MHC Regulations) regarding stock benefit plans established after mutual-to-stock conversions or in mutual holding company (MHC) structures. 1

For several years, the MHC Regulations have required that a majority of the outstanding minority shares approve stock benefit plans. In the NPR, OTS proposed to reduce the voting requirements for the establishment of stock benefit plans in MHC structures, by: (1) Eliminating the requirement for a separate minority shareholder vote when more than a year has passed after a Minority Stock Issuance that was conducted in accordance with the stock purchase priorities set forth in Part 563b; and (2) during the first year after a Minority Stock Issuance conducted in accordance with the Part 563b conversion priorities, requiring that a majority of the minority shares that actually vote on the matter, as opposed to a majority of outstanding minority shares, approve the stock benefit plans.

In addition, OTS proposed a number of other changes to its regulations. OTS proposed, among other things, to: (i) Clarify the Conversion Regulations and the MHC Regulations by referring to the specific type of plan addressed, rather than referring to plans in terms of their tax-qualified or non-tax qualified nature; (ii) eliminate 12 CFR 575.7(b)(3), which requires stock offering materials to disclose the amount of any discount on minority stock; (iii) add certain provisions to the plan size limits in sections 575.8(a)(3) and 575.8(a)(4) that parallel the restrictions in the Conversion Regulations; (iv) amend 12 CFR 575.8 to state that the quantitative limits on the size of plans in section 575.8 supersede related quantitative limits in the Conversion Regulations; (v) amend section 575.8 to state that plan restrictions in proposed sections 563b.500(a)(4) through 563b.500(a)(14) apply in the context of a Minority Stock Issuance for only one year after the Subsidiary Company engages in a Minority Stock Issuance that is conducted in accordance with the purchase priorities set forth in the Conversion Regulations; and (vi) amend the Conversion Regulations to permit converting savings associations to set smaller maximum purchase limitations in conversion stock offerings. Also, OTS proposed to move or delete several provisions in order to organize the regulations more effectively and to clarify the regulations.

OTS received 84 comments, from 78 commenters, regarding the NPR. Of these comment letters, 19 were submitted by individual investors, 47 were submitted by savings associations, savings banks, or holding companies, or insiders thereof, two were submitted by legal counsel for savings associations or holding companies, eight were submitted by investment advisors and related entities, two were submitted by counsel for investment advisors, and six were submitted by trade associations.

All of the comment letters except one (that is, 83 comments) addressed, either solely, or among other issues, the issue of the elimination of the minority vote more than one year after completion of a Minority Stock Issuance.

Of these 83 comments, 53 were in favor of the proposed elimination of the vote requirement, and 30 objected to the elimination of the requirement. The comments were, without exception, divided based on the type of commenter. All of the comments in favor of the proposal were submitted by savings associations or savings banks, holding companies, insiders of such entities, counsel that routinely represents such entities, or trade associations that include such entities. All of the comments from individual investors, investment advisors, counsel for investment advisors, and one trade association that does not have savings associations as members, opposed the elimination of the voting requirement.

Of the 53 comments in favor of the proposed change, 45 indicated that the minority voting requirement enables minority shareholders to obtain leverage in the affairs of the Subsidiary Company beyond the confines of the establishment of a plan, and to engage in hostile activities. Certain of the comments claimed that activist shareholders' concerns are not with the plans themselves, but that activist shareholders use the leverage that the vote on such plans provides, in order to pursue other goals. Forty comments claimed that the minority vote “disenfranchises” the MHC. Eight comments claimed that a minority vote is contrary to the concept of MHC control over the Subsidiary Company, and three comments claimed that the proposal “preserves the full benefits of the MHC charter.” Four comments claimed that the minority vote ignores the interests of depositors.

Also, 41 comments asserted that minority voting requirements are unnecessary because OTS imposes restrictions on the size of plans, and 39 comments claimed that market forces will limit plans to reasonable levels. One comment noted that the staff of the Federal Deposit Insurance Corporation (FDIC) has provided advice that the lack of a minority vote after one year is acceptable. 2 One comment noted that there is no “majority of the minority” voting requirement under state law. Another comment observed that nothing in stock exchange rules or the NASDAQ rules requires a majority of the minority vote when there is a majority shareholder.

Three comments claimed that the minority vote requirement was unduly burdensome. One comment claimed that the minority vote might hamper the ability of an institution to attract management. One comment claimed that a minority vote was unnecessary because directors have fiduciary duties, and must comply with them. Finally, two comments stated that investors who object to the lack of a minority vote simply should not purchase the stock.

Of the 30 comments that objected to the proposal, 26 stated that the elimination of the voting requirement presented conflict of interest concerns. Eight comments stated that the proposal was contrary to good corporate governance. Two comments claimed that the lack of a voting requirement amounts to an exemption from OTS' Conflicts of Interest Regulation (Conflict Regulation). 3 In addition, two comments claimed that the proposal would harm shareholders.

Three comments asserted that plans are “excessive” or “significant” already. Four comments stated that, in light of recent concerns regarding options, or recent corporate problems, this was not an optimal time to make the proposed changes. Three comments stated that the requirement for a minority vote is not unduly restrictive, either because the minority vote adds little actual expense, or because the benefits are worth the expense. Three commenters claimed that the proposal, if adopted, will have an unfavorable effect on the cost of capital, or will not help the market for the securities. One comment stated that, to the extent the regulation would cause Subsidiary Companies to wait until a year has passed to enact stock benefit plans, the plans would be more expensive, because it is likely the stock price would rise over time.

Four of the comments that objected to the proposal claimed that depositors of the MHC have no real voice in the selection of the MHC's directors. Two comments suggested that benefit plans should be put to a depositor vote.

Two comments objected to the applicability of the rule to existing MHC structures, and indicated that the regulation, if adopted, should apply only to MHC structures established after promulgation of the proposed regulation. Finally, seven comments claimed that OTS did not provide a sufficient explanation for the proposed rule change. Forty-six comments addressed other aspects of the NPR. Of these comments, 37 were form letters from savings associations and savings banks that generally praised the proposed regulations for clarifying the regulations. Two comments objected to the change to the majority of the minority vote requirement from a majority of outstanding shares to a majority of shares actually voting. Four comments stated that the regulations would reduce regulatory burden. Two comments supported the reduction in the maximum purchase limitations for stock offerings. One comment expressed support for the proposed changes to several specific provisions of § 575.8.

One comment questioned the need to eliminate the requirement to disclose the reasons for the discount on minority stock in a Minority Stock Issuance. Finally, six other comments suggested certain specific changes to the regulation, which are discussed separately below.

OTS, in issuing the NPR, stated that it believed the minority vote requirement after one year was unduly restrictive. In full conversions, the Conversion Regulations require a vote for only one year after the mutual-to-stock conversion. While Minority Stock Issuances are distinguishable from full conversions because Subsidiary Companies that issue stock have a continuing mutual interest, and entities that complete a full conversion do not have such an interest, stock benefit plans established more than one year after a Minority Stock Issuance do not affect the mutual interest if the plans are funded with stock repurchases. Under such circumstances, plans do not reduce the percentage of stock held by minority shareholders below the percentage that they held upon completion of the Minority Stock Issuance.

Also, although the “majority of the minority” voting requirement has existed for over ten years, it is our understanding that a stock benefit plan put to a shareholder vote has never failed to receive the requisite vote. Under these circumstances, and given the regulatory burdens to which depository institutions are subjected, it is appropriate to inquire whether the cost of obtaining a vote exceeds the benefits.

Further, the FDIC has not required a “majority of the minority” vote more than one year after a minority stock issuance. 4 Therefore, under existing regulations, OTS has been subjecting MHC structures that are under its jurisdiction to requirements that are more onerous than MHC structures that are regulated by the FDIC.

OTS has carefully considered the comments received in response to the NPR. Most of the comments that opposed the proposed elimination of the majority of the minority vote requirement after one year following a Minority Stock Issuance asserted that the proposal created an unacceptable conflict of interest. Without the requirement of a separate minority vote, conflicts of interest exist in the context of stock benefit plans in an MHC structure, because individuals who direct the voting of the MHC's stock also participate in the plan.

The commenters who noted that stock exchange rules and state authorities do not require a separate minority vote where there is a majority shareholder are correct. However, it is not the mere existence of a majority shareholder that may raise conflict of interest concerns. Instead, it is the fact that in MHC structures, the individuals who direct the vote of the MHC's shares have participants in the stock benefit plans that the MHC votes to authorize.

Several commenters claimed that, notwithstanding any potential conflict of interest, a minority vote was unnecessary because directors already have fiduciary duties, OTS regulates the size of plans, or market forces will control the size of plans. OTS does not believe, however, that the existence of fiduciary duties guarantees that parties with such duties will always act appropriately. For example, the Conflict Regulation states that directors and other parties have fiduciary duties, but imposes certain requirements to ensure that the relevant parties comply with their fiduciary duties. Also, although OTS regulations provide some limitations on the size of stock benefit plans, OTS believes that, within such limitations (absent supervisory concerns), the size of plans is a shareholder decision. Further, while accounting and disclosure requirements exist with respect to stock benefit plans, such requirements do not necessarily eliminate conflict of interest issues.

The essence of several comments that supported the proposal was that the MHC should always have the sole ability to control the operations of the Subsidiary Company. Historically, however, OTS has required a majority of the minority vote when a Subsidiary Company proposes to engage in certain actions that would have a significant direct effect on minority shareholders. 5 Although the relevant statutes and regulations generally preserve the continuing control of the mutual, majority interest, OTS has long recognized that it is appropriate to consider minority interests separately in certain situations. 6

Several commenters who supported the proposal asserted that activist shareholders often have used the minority vote requirement for stock benefit plans as leverage to influence management to take actions the activist shareholders sought on other matters. Even if certain minority shareholders have used the minority vote requirement as a means of pursuing other interests, however, it does not mean that the purpose of the minority voting requirements is invalid.

Having considered the public comments, and considering the conflict of interest issues involved, OTS concludes that it is appropriate to continue to impose the separate minority shareholder vote requirement for stock benefit plans in MHC structures, regardless of the amount of time that has passed since the most recent Minority Stock Issuance.

In the NPR, OTS proposed to change the minority vote required for approval of a stock benefit plan, from a majority of all outstanding minority shares to a majority of minority shares actually voting. OTS believes this change is appropriate because a simple majority shareholder vote is the standard for approval of most corporate measures. While the OTS stock charter requires that a majority of all shareholders vote on plans, the charter itself does not require a majority of the minority vote on any issue. OTS believes that in instances where a stock benefit plan is presented for a shareholder vote, it is reasonable to consider only the votes of the minority shareholders voting on the plan issue, particularly given that all minority shareholders are given notice of the vote, and such notice will be required to set forth the applicable vote requirement.

In the NPR, OTS proposed to clarify 12 CFR 563b.500(a) by referring to the specific type of plan addressed (that is, an Employee Stock Ownership Plan (ESOP), Stock Option Plan (Option Plan), or Management Recognition Plan (MRP)), rather than referring to plans in terms of their tax-qualified or non-tax-qualified nature. One commenter objected to this proposed change as it related to tax-qualified plans, noting that converting savings associations do implement tax-qualified plans other than ESOPs.

OTS believes that the proposed regulation adequately addressed the possibility that tax-qualified plans would not necessarily be ESOPs. Proposed section 563b.500(a) defined the term “ESOP” as an employee stock ownership plan or other tax-qualified employee stock benefit plan. Accordingly, OTS is not revising this provision in the final regulations. OTS is, however, revising the definition of the term “ESOP” in section 575.8(a)(3) to conform to the section 563b.500(a) definition.

One commenter claimed that sections 563b.500(a)(4) and 563b.500(a)(5), as proposed, were ambiguous. The commenter claimed that section 563b.500(a)(4) could be read either as limiting an individual to receiving 25 percent or less of the shares of each type of plan, or as applying to 25 percent of all of the shares issued under the various plans. Proposed section 563b.500(a)(4) required that “[n]o individual receives more than 25 percent of the shares under your ESOP, MRP, or Option Plan.” In order to make it clear that the 25 percent limitation will be applied to each plan separately, OTS is revising the regulation to require that no individual receive more than 25 percent of the shares under “any plan.”

Proposed section 563b.500(a)(5) required that “[y]our directors who are not your officers do not receive more than five percent of the shares of your MRP or Option Plan individually, or 30 percent of any such plan in the aggregate.” Although the proposal did not revise the language of the previous regulatory requirement, and parties engaging in conversions or Minority Stock Issuances have not claimed the language is unclear, OTS is revising the section to provide greater clarity. The final regulation provides that “Each of your directors who is not an officer does not receive more than five percent of the shares of your MRP or Option Plan, and all of your directors who are not officers do not receive, in the aggregate, more than 30 percent of the shares of your MRP or Option Plan.”

In the NPR, OTS proposed to rescind 12 CFR 575.7(b)(3), which requires stock offering materials to disclose the amount of any discount on minority stock due to the minority status of the stock to be offered, and how the amount of the discount was determined. OTS explained that the general securities offering disclosure requirements, which require disclosure of material information, are sufficient to address the issue of disclosure of the amount and reasons for any such discount.

One commenter believed that more explanation regarding this proposed change was appropriate, including an explanation of why OTS did not consider generally applicable securities disclosure requirements to provide a basis for sufficient disclosure when the regulation was initially promulgated.

Information regarding the amount and derivation of the discount on Minority Stock Issuances due to the minority nature of the stock is included in the appraisal for the securities offering, which is an exhibit to the offering materials. Accordingly, information regarding the discount is available to any potential purchaser in the Minority Stock Issuance.

Where OTS determines that one of its regulatory requirements is redundant, OTS believes it is appropriate to remove the redundant requirement. Accordingly, OTS is rescinding section 575.7(b)(3) as proposed.

The restrictions on the size of stock benefit plans set forth at 12 CFR 575.8(a)(3) through 575.8(a)(7) are set forth both in terms of the percentage of the savings association's outstanding common stock and in terms of the percentage of the savings association's stockholders' equity. One commenter suggested that all limits based on the equity of a savings association should be eliminated, and stated that such limits penalize holding companies that leverage their capital to generate better returns for stockholders.

The NPR did not propose any substantive change in the limitations in section 575.8(a) pertaining to stockholders' equity. These limitations have been in place since the MHC Regulations were initially promulgated in 1993. OTS is not aware of any situations in which the stockholders' equity provisions placed an additional burden on MHCs. Moreover, OTS believes it is appropriate to include a limitation based on the equity of a Subsidiary Company, given that stock benefit plans award management a share of the equity of the Subsidiary Company.

In the NPR, OTS proposed to retain the existing aggregate limitation on the size of the Option Plans and MRPs set forth at section 575.8(a)(9) of the MHC Regulations, and to clarify that the limitation therein is a separate limitation on Option Plans and MRPs that applies to each Minority Stock Issuance. One commenter suggested that the section be revised to provide that existing benefit plans would not have to be reduced if those plans exceeded the 25 percent limitation as a result of stock repurchases. OTS does not intend to require a reduction in the size of preexisting plans in the situation where the common stock encompassed by those plans exceeds 25 percent of the outstanding stock as a result of stock becoming treasury stock through repurchases prior to a new stock issuance. However, because OTS believes that it would be highly unlikely for preexisting plans to continue to exceed the 25 percent limitation after the close of a subsequent stock issuance, even where such plans would exceed the 25 percent limitation prior to the issuance, OTS is not adding language to the regulation that would explicitly except that situation from the regulatory limitation.

OTS has determined that this rule does not involve a change to collections of information previously approved under the Paperwork Reduction Act (44 U.S.C. 3501 et seq. ).

The Director of OTS has determined that this rule does not constitute a “significant regulatory action” for purposes of Executive Order 12866.

Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601), the Director certifies that this rule will not have a significant economic impact on a substantial number of small entities. The rule makes certain changes that should reduce burdens on all savings associations, including small institutions. First, the rule clarifies the regulations regarding stock benefit plans in connection with mutual-to-stock conversions and Minority Stock Issuances. These clarifications will reduce the burden of complying with the OTS regulations on stock benefit plans. Second, OTS has reduced the voting requirement to adopt stock benefit plans in MHC structures, which reduces burden on institutions establishing stock benefit plans. Finally, the rule will reduce burden by broadening the purchase limitations, thereby promoting a wider distribution of stock in a Conversion Offering or Minority Stock Issuance. All of the changes are minor and should not have a significant impact on small institutions. Accordingly, OTS has determined that a Regulatory Flexibility Analysis is not required.

OTS has determined that the rule will not result in expenditures by state, local, or tribal governments or by the private sector of $100 million or more and that a budgetary impact statement is not required under Section 202 of the Unfunded Mandates Reform Act of 1995, Pub. L. 104-4 (Unfunded Mandates Act). The rule would make certain changes that should reduce burdens on savings associations. First, the rule clarifies OTS regulations regarding stock benefit plans in connection with mutual-to-stock conversions and Minority Stock Issuances, which should reduce the burden of complying with the OTS regulations on stock benefit plans. Second, OTS has reduced the voting requirement to adopt stock benefit plans in MHC structures, which reduces burden on institutions establishing stock benefit plans. Finally, the rule will reduce burden by broadening the purchase limitations, to promote a wider distribution of stock in a Conversion Offering or Minority Stock Issuance. All of the changes are minor and should not have a significant impact on small institutions. Accordingly, a budgetary impact statement is not required under section 202 of the Unfunded Mandates Act.

On January 30, 2007, the FAA published a direct final rule (72 FR 4933) amending the renewal period for inspection authorizations. The rule became effective on March 1, 2007.

The direct final rule is the product of discussions between industry representatives (including the Professional Aviation Maintenance Association) and the FAA. The discussions led to a consensus to change the 1-year inspection authorization renewal period to once every two years. Under the direct final rule, the expiration date of an inspection authorization changed from March 31 of each year to March 31 of each odd-numbered year. The intent of the rule is to relieve administrative costs associated with renewing inspection authorizations for both FAA and the IA holders without affecting safety.

The rule retains the annual activity requirement for each year of the 2-year IA period. Consistent with the annual aspects of the former rule, an IA holder must perform one of the five activities listed in § 65.93 (a)(1)-(5) during the first year of the 2-year IA period. A new paragraph (c) states if the IA holder does not complete one of those activities by March 31 of the first year, the holder may not exercise the inspection authorization privileges after that date. However, the holder may resume exercising IA privileges during the second year if the IA holder passes an oral test given by an FAA inspector to determine if the holder's knowledge of applicable regulations and standards is current. If the holder passes the oral test, the FAA will consider the first year requirement completed. Each IA holder must also perform one of the five activities listed in § 65.93 (a)(1)-(5) during the second year of the inspection authorization period to be eligible for renewal.

The FAA received approximately 60 comments in response to the IA renewal period direct final rule. The comments generally were supportive of the two-year renewal period. Commenters stated they were happy to see the FAA become actively involved in reviewing inspection authorization procedures and agreed that the change would result in time and money savings.

Many who commented favorably on the direct final rule also took the opportunity to recommend other and more significant changes to the regulations applicable to IA holders. Several commenters suggested completely restructuring the cycle for renewing IA holders to provide for individual expiration dates for each IA holder based on date of birth or the date of the initial grant of IA authority. A number of commenters said the annual activity requirement should be eliminated and a two-year period for the activity requirement should be established. The Aircraft Electronics Association (AEA) suggested the FAA establish a rating system for IA holders similar to the rating system for repair stations. Several comments addressed matters of the FAA's oversight of IA holders.

These comments will be evaluated by the FAA as it considers possible future actions to amend the rules relating to IAs, but they address matters beyond the limited scope of the direct final rule. The FAA could not adopt those proposals without further rulemaking, and the significance of those actions would require FAA to issue a notice of proposed rulemaking prior to amending the rule.

Three commenters misunderstood one provision in the rule. The rule permits an IA who fails to meet the annual activity requirement during the first year the option to take an oral test from an FAA inspector and thereafter exercise IA privileges during the remainder of the second year of the two-year IA period. For purposes of later renewal, the oral test would be counted as meeting the activity for the first year. (The individual also could choose to reapply for IA authority, the only means available under the prior rule when the activity requirement was not met.) The rule does not require, as these commenters thought, that all IA holders must take an oral test during the two-year IA renewal cycle to be able to renew their authority.

Several commenters mistakenly thought the rule requires each IA holder to submit a list of activities each year to the FAA that demonstrates the IA holder's compliance with the annual activity requirement. This is not the case. Rather, the rule requires an applicant for renewal every two years to present evidence of compliance with the annual activity requirement for each of the preceding two years.

A number of commenters expressed concern that some IA holders inadvertently may continue to exercise IA privileges into the second year of the two-year renewal period even though they failed to meet the annual activity requirement before March 31 of the first year. The FAA is aware of this possibility because similar events occurred under the prior rule. Each year under the old rule, a few IA holders failed to renew during March and then mistakenly continued to perform IA responsibilities. The instances were rare, and the FAA addressed them without significant difficulties as part of its routine oversight of IA holders.

There is a multi-decade history of the annual activity requirement for IA holders and nothing in the rule change disturbed that requirement. Indeed, not only was it retained, but the request for comments on this rule served as a way of reminding IA holders of the longstanding annual activity requirement. The FAA does not expect IA holders to perform differently or to lose sight of this core element of the rule simply because of the two-year renewal cycle. As in the past, the FAA will monitor compliance with the regulations and take enforcement action where appropriate. The FAA also will use the refresher course training curriculum as a way of ensuring that IA holders attending training are reminded of the rule requirement, and FAA inspectors will regularly address the matter in the context of their routine checks of IAs.

Finally, because 2008 will be the first year under the new two-year renewal cycle, FAA will remind each IA of the annual activity requirements for March 2008 through the FAA Information for Operations procedure.

After consideration of the comments submitted in response to the final rule, the FAA has determined that no further rulemaking action is necessary. Amendment 65-50 remains in effect as adopted.

This amendment to Title 14, Code of Federal Regulations, Part 97 (14 CFR part 97) amends Standard Instrument Approach Procedures (SIAPs). The complete regulatory description of each SIAP is contained in the appropriate FAA Form 8260, as modified by the National Flight Data Center (FDC)/Permanent Notice to Airmen (P-NOTAM), which is incorporated by reference in the amendment under 5 U.S.C. 552(a), 1 CFR part 51, and § 97.20 of the Code of Federal Regulations. Materials incorporated by reference are available for examination or purchase as stated above.

The large number of SIAPs, their complex nature, and the need for a special format make their verbatim publication in the Federal Register expensive and impractical. Further, airmen do not use the regulatory text of the SIAPs, but refer to their graphic depiction on charts printed by publishers of aeronautical materials. Thus, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP contained in FAA form documents is unnecessary. The provisions of this amendment state the affected CFR sections, with the types and effective dates of the SIAPs. This amendment also identifies the airport, its location, the procedure identification and the amendment number.

This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP as amended in the transmittal. For safety and timeliness of change considerations, this amendment incorporates only specific changes contained for each SIAP as modified by FDC/P-NOTAMs.

The SIAPs, as modified by FDC P-NOTAM, and contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these chart changes to SIAPs, the TERPS criteria were applied to only these specific conditions existing at the affected airports. All SIAP amendments in this rule have been previously issued by the FAA in a FDC NOTAM as an emergency action of immediate flight safety relating directly to published aeronautical charts. The circumstances which created the need for all these SIAP amendments requires making them effective in less than 30 days.

Further, the SIAPs contained in this amendment are based on the criteria contained in TERPS. Because of the close and immediate relationship between these SIAPs and safety in air commerce, I find that notice and public procedure before adopting these SIAPs are impracticable and contrary to the public interest and, where applicable, that good cause exists for making these SIAPs effective in less than 30 days.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Interested persons are invited to participate in this rulemaking by submitting written data, views, or arguments on all aspects of the interim rule. CBP also invites comments that relate to the economic, environmental, or federalism effects that might result from this interim rule. Comments that will provide the most assistance to CBP will reference a specific portion of the interim rule, explain the reason for any recommended change, and include data, information, or authority that support such recommended change. See ADDRESSES above for information on how to submit comments.

On October 24, 2000, the United States and the Hashemite Kingdom of Jordan (the “Parties”) signed the U.S.-Jordan Free Trade Agreement (“US-JFTA”), which is designed to eliminate tariffs and other trade barriers between the two countries. The provisions of the US-JFTA were adopted by the United States with the enactment on September 28, 2001 of the United States-Jordan Free Trade Area Implementation Act (the “Act”), Public Law 107-43, 115 Stat. 243 (19 U.S.C. 2112 note). On December 7, 2001, the President signed Proclamation 7512 to implement the provisions of the US-JFTA. The Proclamation, which was published in the Federal Register on December 13, 2001 (66 FR 64497), modified the Harmonized Tariff Schedule of the United States (“HTSUS”) as set forth in Annexes I and II of the Proclamation. The modifications to the HTSUS included the addition of new General Note 18, incorporating the relevant US-JFTA rules of origin as set forth in the Act, and the insertion throughout the HTSUS of the preferential duty rates applicable to individual products under the US-JFTA where the special program indicator “JO” appears in parenthesis in the “Special” rate of duty subcolumn.

U.S. Customs and Border Protection (“CBP”) is responsible for administering the provisions of the US-JFTA and the Act that relate to the importation of goods into the United States from Jordan. Therefore, the regulations set forth in this document pertain specifically to US-JFTA customs-related provisions, such as rules of origin, that govern the duty-free or reduced-duty treatment of products imported into the United States from Jordan. These rules do not confer origin or establish a criterion for determining the origin of imported goods for any other purpose. For example, origin determinations for country of origin marking purposes under 19 U.S.C. 1304 are not affected.

Article 2 and Annex 2.2 of the US-JFTA set forth the rules of origin and documentary requirements that apply for purposes of obtaining preferential treatment under the US-JFTA. Annex 2.1 of the US-JFTA sets forth the terms for the immediate elimination or staged reduction of duties on products of Jordan, with all products to become duty free within a ten-year period (by the year 2010).

Under Annex 2.2 of the US-JFTA and § 102 of the Act, to be eligible for reduced or duty-free treatment under the US-JFTA, a good imported into the United States from Jordan must meet three basic requirements: (1) It must be imported directly from Jordan into the customs territory of the United States; (2) it must be a product of Jordan, i.e. , it must be either wholly the growth, product, or manufacture of Jordan or a new or different article of commerce that has been grown, produced, or manufactured in Jordan; and (3) if it is a new or different article of commerce, it must have a minimum domestic content, i.e. , at least 35 percent of its appraised value must be attributed to the cost or value of materials produced in Jordan plus the direct costs of processing operations performed in Jordan. Annex 2.2 of the US-JFTA further provides that: (1) The cost or value of U.S.-produced materials may be counted toward the Jordanian domestic content requirement to a maximum of 15 percent of the appraised value of the imported good; and (2) simple combining or packaging operations or mere dilution with water or another substance will confer neither Jordanian origin on an imported good nor Jordanian or U.S. origin on a constituent material of an imported good.

In addition, for purposes of demonstrating compliance with the origin criteria, Annex 2.2 of the US- JFTA establishes the requirements for submitting a declaration, when requested by CBP, that provides all pertinent information concerning the production or manufacture of an imported good.

In this document, CBP is setting forth in a new Subpart K in Part 10 of title 19 of the Code of Federal Regulations (CBP regulations) on an interim basis, regulations to implement the preferential tariff treatment and other customs-related provisions of the US-JFTA.

The interim regulations are discussed in detail below.

Section 10.701 outlines the scope of new Subpart K, Part 10, of the CBP regulations. This section also clarifies that, except where the context otherwise requires, the requirements contained in Subpart K, Part 10, are in addition to general administrative and enforcement provisions set forth elsewhere in the CBP regulations. Thus, for example, the specific merchandise entry requirements contained in Subpart K, Part 10, are in addition to the basic entry requirements contained in Parts 141-143 of the CBP regulations.

Section 10.702 sets forth definitions of terms or expressions used in multiple contexts or places within Subpart K, Part 10. The definition of “wholly the growth, product, or manufacture of Jordan” in paragraph (r) reflects the definition set forth in Annex 2.2 of the US-JFTA except that reference is made to “Jordan” rather than to a “Party” in order to reflect a U.S. import context. Additional definitions that apply in a more limited Subpart K, Part 10, context are set forth elsewhere with the substantive provisions to which they relate.

Section 10.703 sets forth the procedure for claiming US-JFTA preferential tariff treatment at the time of importation. Unlike certain other free trade agreements to which the United States is a Party, such as the North American Free Trade Agreement (NAFTA) and the United States-Chile Free Trade Agreement (US-CFTA), the US-JFTA does not specify a procedure for making a post-importation claim. Therefore, Subpart K, Part 10, contains no regulatory provisions governing such claims. However, a protest against an alleged error in the liquidation of an entry may be brought under the normal procedures to contest a denial of US-JFTA benefits ( see Part 174, CBP regulations (19 CFR Part 174)).

Section 10.704, as provided in Annex 2.2, paragraph 10(b), of the US-JFTA, requires a U.S. importer, upon request, to submit a declaration setting forth all pertinent information concerning the production or manufacture of the good. Section 10.705 sets forth certain importer obligations regarding the truthfulness of information and documents submitted in support of a claim for preferential tariff treatment.

Section 10.706 provides that the importer's declaration is not required for certain non-commercial or low-value importations.

Section 10.707 implements the portion of Annex 2.2, paragraph 10(b) of the US-JFTA concerning the maintenance of records necessary for the preparation of the declaration.

Section 10.708 provides for the denial of US-JFTA tariff benefits if the importer fails to comply with any of the requirements under Subpart K, Part 10, CBP regulations.

Section 10.709 sets forth the basic country of origin rules for obtaining preferential tariff treatment under the US-JFTA, as set forth in Annex 2.2 of the US-JFTA, § 102 of the Act, and General Note 18, HTSUS. Paragraph (a)(1) requires an eligible US-JFTA good to be either “wholly the growth, product, or manufacture of Jordan” or “new or different article of commerce which has been grown, produced, or manufactured in Jordan,” reflecting standards set forth in Annex 2.2, paragraph 1(a), of the US-JFTA and § 102(a)(1)(A)(ii) of the Act. Paragraph (a)(2) of § 10.709 references the value-content requirement set forth in Annex 2.2, paragraph 1(c), of the US-JFTA and § 102(a)(1)(B) of the Act.

Paragraph (b)(1) of § 10.709 implements Annex 2.2, paragraph 2, of the US-JFTA and § 102(a)(2) of the Act, relating to the simple combining or packaging or mere dilution exceptions to the “new or different article of commerce” requirement. Since the language in the US-JFTA and the Act in this regard is identical to that used in the Caribbean Basin Economic Recovery Act (“CBERA”) ( see 19 U.S.C. 2703(a)(2)), paragraph (b)(1) incorporates by reference the examples and principles set forth in § 10.195(a)(2) of CBP's implementing CBERA regulations (19 CFR 10.195(a)(2)). Paragraph (b)(2) reflects the exception to the “new or different article of commerce” requirement set forth in the footnote to Annex 2.2, paragraph 4, of the US-JFTA and in § 102(d) of the Act, relating to the processing of certain fruits into juices.

Paragraph (c) of § 10.709 provides that the rules of origin for textile and apparel products found in § 102.21 of the CBP regulations (19 CFR 102.21) will be used to determine whether textile and apparel goods from Jordan satisfy the “wholly the growth, product, or manufacture” or “new or different article of commerce” requirements of § 10.709(a), consistent with Annex 2.2, paragraph 9, of the US-JFTA and § 102(c) of the Act.

Section 10.710 sets forth provisions relating to the 35 percent value-content requirement of the US-JFTA. Paragraph (a) specifies the basic requirement contained in Annex 2.2, paragraph 1(c), of the US-JFTA and § 102(a)(1)(B)(i) of the Act.

Paragraph (b) allows the inclusion of U.S.-produced materials up to 15 percent of the appraised value, as provided for in Annex 2.2, paragraph 5, of the US-JFTA and § 102(a)(1)(B)(ii) of the Act. Paragraph (c) concerns the cost or value of materials that may be applied toward satisfaction of the 35 percent value-content requirement and is based on provisions contained in the US-JFTA, the Act, and § 10.196 of CBP's CBERA regulations (19 CFR 10.196). Paragraph (c)(1) defines “materials produced in Jordan” in a manner similar to the approach taken in section 10.196(a) of CBP's CBERA regulations. Paragraph (c)(1)(ii) was specifically drafted to reflect: (1) The application of the simple combining or packaging or mere dilution language to materials, as provided in Annex 2.2, paragraph 2, of the US-JFTA; and (2) the country of origin language which also applies to materials under Annex 2.2, paragraph 4, of the US-JFTA. The last sentence of paragraph (c)(1)(ii) refers to the useful examples contained in § 10.196(a) of CBP's CBERA regulations, and the words “except where the context otherwise requires” are intended to alert the reader to the fact that some aspects of those examples apply only in a CBERA context. Paragraph (c)(2) sets forth the elements includable under the cost or value of materials, as provided in Annex 2.2, paragraph 6, of the US-JFTA.

Paragraph (d) sets forth provisions regarding direct costs of processing operations for purposes of the 35 percent value-content requirement, as contained in Annex 2.2, paragraph 7, of the US-JFTA and § 102(b) of the Act.

Section 10.711 reflects the definition of “imported directly,” as set forth in Annex 2.2, paragraph 8, of the US-JFTA.

Section 10.712 provides that claims for preferential tariff treatment under the US-JFTA will be subject to such verification as the CBP port director deems necessary.

Under the Administrative Procedure Act (“APA”) (5 U.S.C. 553), agencies generally are required to publish a notice of proposed rulemaking in the Federal Register that solicits public comment on the proposed regulatory amendments, consider public comments in deciding on the content of the final amendments, and publish the final amendments at least 30 days prior to their effective date. However, section 553(a)(1) of the APA provides that the standard prior notice and comment procedures and delayed effective date provisions of 5 U.S.C. 553(d) do not apply to an agency rulemaking to the extent that it involves a foreign affairs function of the United States. CBP has determined that these interim regulations involve a foreign affairs function of the United States because they implement preferential tariff treatment and related provisions of the US-JFTA. Therefore, the rulemaking requirements under the APA do not apply and this interim rule will be effective upon publication. However, CBP is soliciting comments in this interim rule and will consider all comments it receives before issuing a final rule.

CBP has determined that this document is not a regulation or rule subject to the provisions of Executive Order 12866 of September 30, 1993 (58 FR 51735, October 1993), because it pertains to a foreign affairs function of the United States and implements an international agreement, as described above, and therefore is specifically exempted by section 3(d)(2) of Executive Order 12866. Because a notice of proposed rulemaking is not required under section 553(b) of the APA for the reasons described above, CBP notes that the provisions of the Regulatory Flexibility Act, as amended (5 U.S.C. 601 et seq. ), do not apply to this rulemaking. Accordingly, CBP also notes that this interim rule is not subject to the regulatory analysis requirements or other requirements of 5 U.S.C. 603 and 604.

These regulations are being issued without prior notice and public procedure pursuant to the Administrative Procedure Act (5 U.S.C. 553). For this reason, the collections of information contained in these regulations have been reviewed and, pending receipt and evaluation of public comments, approved by the Office of Management and Budget in accordance with the requirements of the Paperwork Reduction Act (44 U.S.C. 3507) under control number 1651-0128.

The collections of information in these regulations are in §§ 10.703 and 10.704. This information is required in connection with claims for preferential tariff treatment and for the purpose of the exercise of other rights under the US-JFTA and the Act and will be used by CBP to determine eligibility for a tariff preference or other rights or benefits under the US-JFTA and the Act. The likely respondents are business organizations including importers, exporters and manufacturers.

Estimated total annual reporting burden: 500.

Estimated average annual burden per respondent: 12 minutes.

Estimated number of respondents: 2,500.

Estimated annual frequency of responses: 1.

Comments concerning the collections of information and the accuracy of the estimated annual burden, and suggestions for reducing that burden, should be directed to the Office of Management and Budget, Attention: Desk Officer for the Department of the Treasury, Office of Information and Regulatory Affairs, Washington, DC 20503. A copy should also be sent to the Trade and Commercial Regulations Branch, Regulations and Rulings, U.S. Customs and Border Protection, 1300 Pennsylvania Avenue, NW. (Mint Annex), Washington, DC 20229.

This document is being issued in accordance with section 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 Atlantic Beach Bridge, across Reynolds Channel, mile 0.4, at Atlantic Beach, New York, has a vertical clearance in the closed position of 25 feet at mean high water and 30 feet at mean low water. The existing drawbridge operation regulations are listed at 33 CFR 117.799(e).

The owner of the bridge, Nassau County Bridge Authority, requested a temporary deviation to facilitate the replacement of steel deck grating at the bridge.

Under this temporary deviation, from July 23, 2007 through August 3, 2007, a one-hour advance notice for bridge openings shall be required between 7 a.m. and 3:30 p.m., Monday through Friday, at the Atlantic Beach Bridge, mile 0.4, across Reynolds Channel, at Atlantic Beach, New York. Notice may be given by calling the bridge tender on VHF channel 13, or by telephone at (516) 239-1821.

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

Regulatory Information

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(3)(B), the Coast Guard finds that good cause exists for not publishing an NPRM. The permit application was not received in time to publish an NPRM followed by a final rule before the effective date. Under 5 U.S.C. 553(d)(3), good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Delaying this rule would be contrary to the public interest of ensuring the safety of spectators and vessels during this event and immediate action is necessary to prevent possible loss of life or property.

This temporary safety zone is necessary to ensure the safety of vessels and spectators from hazards associated with a fireworks display. Based on accidents that have occurred in other Captain of the Port Zones, and the explosive hazards of fireworks, the Captain of the Port Buffalo has determined that fireworks launches proximate to watercraft pose significant risk to public safety and property. The likely combination of large numbers of recreation vessels, congested waterways, darkness punctuated by bright flashes of light, alcohol use, and debris falling into the water could easily result in serious injuries or fatalities. Establishing a safety zone to control vessel movement around the location of the launch platform will help ensure the safety of persons and property at these events and help minimize the associated risks.

A temporary safety zone is necessary to ensure the safety of spectators and vessels during the setup, loading and launching of a fireworks display in conjunction with the Ferrier Picnic fireworks display. The fireworks display will occur between 9:30 p.m. and 9:45 p.m. on July 1, 2007.

The safety zone for the fireworks will encompass all waters of Lake Erie, Fairview, PA within a three hundred foot radius of position 42°04′19″ N, 080°14′40″ W. [DATUM: NAD 83].

All persons and vessels shall comply with the instructions of the Coast Guard Captain of the Port or the designated on-scene representative. Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Buffalo or his designated on-scene representative. The Captain of the Port Buffalo or his designated on-scene representative may be contacted via VHF Channel 16.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that order.

This determination is based on the minimal time that vessels will be restricted from the safety zone and the safety zone is an area where the Coast Guard expects insignificant adverse impact to mariners from the safety zone's activation.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

This rule will affect the following entities, some of which may be small entities: The owners and operators of vessels intending to transit or anchor in a portion of Lake Erie, Fairview, PA between 9:30 p.m. and 9:45 p.m. on July 1, 2007.

This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons: This rule will be in effect for fifteen minutes for one event. Vessel traffic can safely pass outside the safety zone during the event. In the event that this temporary safety zone affects shipping, commercial vessels may request permission from the Captain of the Port Buffalo to transit through the safety zone. The Coast Guard will give notice to the public via a Broadcast to Mariners that the regulation is in effect.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offered to assist small entities in understanding the rule so that they could better evaluate its effects on them and participate in the rulemaking process. Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.

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

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

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

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

The Coast Guard recognizes the treaty rights of Native American Tribes. Moreover, the Coast Guard is committed to working with Tribal Governments to implement local policies and to mitigate tribal concerns. We have determined that this safety zone and fishing rights protection need not be incompatible. We have also determined that this Rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. Nevertheless, Indian Tribes that have questions concerning the provisions of this Rule or options for compliance are encouraged to contact the point of contact listed under FOR FURTHER INFORMATION CONTACT .

We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a statement of Energy Effects under Executive Order 13211.

The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., specifications of materials, performance, design, or operation; test methods; sampling procedure; and related management system practices) that are developed or adopted by voluntary consensus standards bodies.

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

We have analyzed this rule under Commandant Instruction M16475.lD, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (34)(g), of the Instruction, from further environmental documentation. This event establishes a safety zone therefore paragraph (34)(g) of the Instruction applies.

A final “Environmental Analysis Check List” and a final “Categorical Exclusion Determination” are available in the docket where indicated under ADDRESSES .

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM. The Coast Guard did not receive an Application for Approval of Marine Event for this event with sufficient time to implement an NPRM. A delay or cancellation of the fireworks display in order to accommodate a full notice and comment period would be contrary to the public interest.

Under 5 U.S.C. 553(d)(3), the Coast Guard also finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Any delay encountered in this regulation's effective date would be impracticable and contrary to public interest since immediate action is needed to prevent traffic from transiting a portion of Long Island Sound off East Beach, Port Jefferson, NY and to protect the maritime public from the hazards associated with this fireworks event.

The temporary zone should have minimal negative impact on the public and navigation because it will be enforced for a three hour period on only one of two specified days. In addition, the area closed by the safety zone is minimal, allowing vessels to transit around the zone in Long Island Sound off Port Jefferson, NY.

The Port Jefferson Fireworks display will take place on East Beach, Port Jefferson, NY from 8 p.m. to 11 p.m. on July 4, 2007. If the fireworks display is cancelled due to inclement weather on July 4, 2007, it will take place during the same hours on July 5, 2007. This safety zone is necessary to protect the life and property of the maritime public from the hazards posed by the fireworks display. It will protect the maritime public by prohibiting entry into or movement within this portion of Long Island Sound one hour prior to, during and one hour after the stated event.

This regulation establishes a temporary safety zone on the navigable waters of Long Island Sound off East Beach, Port Jefferson, NY within a five hundred foot radius of the fireworks launch site located at approximate position 40°57′53.189″ N, 073°03′9.72″ W. The temporary safety zone will be outlined by temporary marker buoys installed by the event organizers.

This action is intended to prohibit vessel traffic in a portion of Long Island Sound off East Beach, Port Jefferson, NY to provide for the protection of life and property of the maritime public. The safety zone will be enforced from 8 p.m. until 11 p.m. on July 4, 2007. Alternatively, if the fireworks display is cancelled due to inclement weather on July 4, 2007, the zone will be enforced during the same hours on July 5, 2007. Marine traffic may transit safely outside of the safety zone during the event thereby allowing navigation of the rest of Long Island Sound except for the portion delineated by this rule.

The Captain of the Port anticipates minimal negative impact on vessel traffic due to this event because of the safety zone's small size and duration. Public notifications will be made prior to the effective period via local notice to mariners and marine information broadcasts.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order.

This regulation may have some impact on the public, but the potential impact will be minimized for the following reasons: Vessels will only be excluded from the area of the safety zone for 3 hours; and vessels will be able to operate in other areas of Long Island Sound off Port Jefferson, NY during the enforcement period.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this rule will have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule may affect the following entities, some of which may be small entities: The owners or operators of vessels intending to transit or anchor in those portions of Long Island Sound off Port Jefferson, NY covered by the safety zone. For the reasons outlined in the Regulatory Evaluation section above, this rule will not have a significant impact on a substantial number of small entities.

Under subsection 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 [Pub. L. 104-121], the Coast Guard wants to assist small entities in understanding this rule so that they can better evaluate its effects on them and participate in the rulemaking process.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about the rule or any policy of the Coast Guard.

This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.

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

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

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

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

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it 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.

We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies.

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

We have analyzed this rule under Commandant Instruction M16475.1D and Department of Homeland Security Management Directive 5100.1, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of the categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (34)(g), of the Instruction, from further environmental documentation. This rule falls under the provisions of paragraph (34)(g) because the rule establishes a safety zone.

A final “Environmental Analysis Check List” and a final “Categorical Exclusion Determination” will be available in the docket where indicated under ADDRESSES .

Regulatory Information

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(3)(B), the Coast Guard finds that good cause exists for not publishing an NPRM. The permit application was not received in time to publish an NPRM followed by a final rule before the effective date. Under 5 U.S.C. 553(d)(3), good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Delaying this rule would be contrary to the public interest of ensuring the safety of spectators and vessels during this event and immediate action is necessary to prevent possible loss of life or property.

This temporary safety zone is necessary to ensure the safety of vessels and spectators from hazards associated with a fireworks display. Based on accidents that have occurred in other Captain of the Port zones, and the explosive hazards of fireworks, the Captain of the Port Buffalo has determined that fireworks launches in close proximity to watercraft pose significant risk to public safety and property. The likely combination of large numbers of recreation vessels, congested waterways, darkness punctuated by bright flashes of light, alcohol use, and debris falling into the water could easily result in serious injuries or fatalities. Establishing a safety zone to control vessel movement around the location of the launch platform will help ensure the safety of persons and property at these events and help minimize the associated risks.

A temporary safety zone is necessary to ensure the safety of spectators and vessels during the setup, loading and launching of a fireworks display in conjunction with the City of Syracuse fireworks display. The fireworks display will occur between 9:30 p.m. and 10:30 p.m. on June 29, 2007.

The safety zone for the fireworks will encompass all waters of the Syracuse Inner Harbor and Onondaga Lake within a three hundred fifty foot radius of position 43°03′37″ N, 076°09′59″ W. [DATUM: NAD 83].

All persons and vessels shall comply with the instructions of the Coast Guard Captain of the Port or the designated on-scene representative. Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Buffalo or his designated on-scene representative. The Captain of the Port or his designated on-scene representative may be contacted via VHF Channel 16.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order.

This determination is based on the minimal time that vessels will be restricted from the safety zone and the safety zone is an area where the Coast Guard expects insignificant adverse impact to mariners from the safety zone's activation.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

This rule will affect the following entities, some of which may be small entities: the owners and operators of vessels intending to transit or anchor in a portion of the Syracuse Harbor, Syracuse, NY between 9:30 p.m. and 10:30 p.m. on June 29, 2007.

This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons: this rule will be in effect for only one hour. Vessel traffic can safely pass outside the safety zone during the event. In the event that this temporary safety zone affects shipping, commercial vessels may request permission from the Captain of the Port Buffalo to transit through the safety zone. The Coast Guard will give notice to the public via a Broadcast to Mariners that the regulation is in effect.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offered to assist small entities in understanding the rule so that they could better evaluate its effects on them and participate in the rulemaking process. Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about the rule or any policy of the Coast Guard.

This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.

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

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

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

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

The Coast Guard recognizes the treaty rights of Native American Tribes. Moreover, the Coast Guard is committed to working with Tribal Governments to implement local policies and to mitigate tribal concerns. We have determined that this safety zone and fishing rights protection need not be incompatible. We have also determined that this Rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. Nevertheless, Indian Tribes that have questions concerning the provisions of this Rule or options for compliance are encouraged to contact the point of contact listed under FOR FURTHER INFORMATION CONTACT .

We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a statement of Energy Effects under Executive Order 13211.

The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., specifications of materials, performance, design, or operation; test methods; sampling procedure; and related management system practices) that are developed or adopted by voluntary consensus standards bodies.

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

We have analyzed this rule under Commandant Instruction M16475.lD, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (34)(g), of the Instruction, from further environmental documentation. This event establishes a safety zone therefore paragraph (34)(g) of the Instruction applies.

A final “Environmental Analysis Check List” and a final “Categorical Exclusion Determination” are available in the docket where indicated under ADDRESSES .

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM. The Coast Guard did not receive an Application for Approval of Marine Event for this event with sufficient time to implement an NPRM, thereby making an NPRM impracticable and contrary to the public interest. A delay or cancellation of the fireworks display in order to accommodate a full notice and comment period would be contrary to the public interest.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Any delay encountered in this regulation's effective date would be impracticable and contrary to public interest since immediate action is needed to prevent traffic from transiting a portion of Bayville, NY and to protect the maritime public from the hazards associated with this fireworks event.

The Cancer Center for Kids Fireworks display will be taking place in Bayville, NY from 8 p.m. to 11 p.m. on June 30, 2007. This safety zone is necessary to protect the life and property of the maritime public from the hazards posed by the fireworks display. It will protect the maritime public by prohibiting entry into or movement within the navigable waters of this portion of Long Island Sound one hour prior to, during and one hour after the stated event.

This regulation establishes a temporary safety zone on the navigable waters of Bayville, NY within a 600-foot radius of the fireworks barge located at approximate position 40°55′19.8587″ N, 073°34′41.9700″ W. The temporary safety zone will be outlined by temporary marker buoys installed by the event organizers.

This action is intended to prohibit vessel traffic in a portion of Bayville, NY to provide for the protection of life and property of the maritime public. The safety zone will be enforced from 8 p.m. until 11 p.m. on June 30, 2007. Marine traffic may transit safely outside of the safety zone during the event thereby allowing navigation of the rest of Long Island Sound except for the portion delineated by this rule.

The Captain of the Port anticipates minimal negative impact on vessel traffic from this event due to the limited area and duration covered by this safety zone. Public notifications will be made prior to the effective period via local notice to mariners and marine information broadcasts.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order.

This regulation should have minimal negative impact on the public and navigation because it is only effective for a three hour period on a single day. In addition, the area closed by the safety zone is minimal, allowing vessels to transit around the zone in Bayville, NY.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this rule will have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule may affect the following entities, some of which may be small entities: the owners or operators of vessels intending to transit or anchor in those portions of Long Island Sound covered by the safety zone. For the reasons outlined in the Regulatory Evaluation section above, this rule will not have a significant impact on a substantial number of small entities.

If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see ADDRESSES ) explaining why you think it qualifies and how and to what degree this rule would economically affect it.

Under subsection 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 [Pub. L. 104-121], the Coast Guard wants to assist small entities in understanding this rule so that they can better evaluate its effects on them and participate in the rulemaking. If this rule will affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please call Lieutenant D. Miller, Chief, Waterways Management Division, Sector Long Island Sound, at (203) 468-4596.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.

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

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

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

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

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it 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.

We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies.

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

We have analyzed this rule under Commandant Instruction M16475.1D and Department of Homeland Security Management Directive 5100.1, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of the categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (34)(g), of the Instruction, from further environmental documentation. This rule falls under the provisions of paragraph (34)(g) because the rule establishes a safety zone.

A final “Environmental Analysis Check List” and a final “Categorical Exclusion Determination” will be available in the docket where indicated under ADDRESSES .

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. As the fireworks display is scheduled to occur on July 1, 2007, any delay encountered in the regulation's effective date would be contrary to the public interest since the safety zone is needed to prevent traffic from transiting a portion of Hingham Inner Harbor during the fireworks display thus ensuring that the maritime public is protected from any potential harm associated with such an event. Additionally, the zone should have negligible impact on vessel transits due to the fact that vessels will be limited from the area for only two hours and fifteen minutes and vessels can still transit in the majority of Hingham Inner Harbor during the event. Accordingly, under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM.

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

This rule establishes a safety zone on the navigable waters of Hingham Inner Harbor within a 500-yard radius of the fireworks barge located at approximate position 42°015.30′ N, 070 °53.02′ W. The safety zone is in effect from 8:45 p.m. until 11 p.m. on July 1, 2007. The rain date for the fireworks event is from 8:45 p.m. until 11 p.m. on July 2, 2007.

The safety zone temporarily restricts movement within this portion of Hingham Inner Harbor and is needed to protect the maritime public from the dangers posed by a fireworks display. Marine traffic may transit safely outside of the zone during the enforcement period. The Captain of the Port does not anticipate any negative impact on vessel traffic due to the event. Public notification will be made prior to the enforcement period via marine information broadcasts and Local Notice to Mariners.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order.

Although this rule prevents vessel traffic from transiting a portion of Hingham Inner Harbor during the enforcement period, the effects of this regulation will not be significant for several reasons: vessels will be excluded from the proscribed area for only two hours and fifteen minutes, vessels will be able to operate in the majority of Hingham Inner Harbor during the effective period, and advance notifications will be made to the local maritime community by marine information broadcasts and Local Notice to Mariners.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

This rule will affect the following entities, some of which may be small entities: the owners or operators of vessels intending to transit or anchor in a portion of Hingham Inner Harbor from 8:45 p.m. until 11 p.m. on July 1, 2007. The rain date for the fireworks event is from 8:45 p.m. until 11 p.m. on July 2, 2007.

This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons: this rule will be in effect for only two hours and fifteen minutes, vessel traffic can safely pass around the zone, and advance notification will be made to the local maritime community by marine information broadcasts and Local Notice to Mariners.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offered to assist small entities in understanding the rule so that they could better evaluate its effects on them and participate in the rulemaking process.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.

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

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

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

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

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

We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies.

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

We have analyzed this rule under Commandant Instruction M16475.1D and Department of Homeland Security Management Directive 5100.1, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (34)(g) of the Instruction, from further environmental documentation. This rule fits the category selected from paragraph (34)(g), as it would establish a safety zone. A final “Environmental Analysis Check List” and a final “Categorical Exclusion Determination” will be available in the docket where indicated under ADDRESSES .

Regulatory Information

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM. An NPRM was not published for this regulation because the logistics with respect to the fireworks presentation were not determined with sufficient time to draft and publish an NPRM. Any delay encountered in this regulation's effective date would be contrary to the public interest since the safety zone is needed to prevent traffic from transiting a portion of the Pickering Wharf Channel during the fireworks display and to provide for the safety of life on navigable waters.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Any delay encountered in this regulation's effective date would be contrary to the public interest since the safety zone is needed to prevent traffic from transiting a portion of the Pickering Wharf Channel during the fireworks event thus ensuring that the maritime public is protected from any potential harm associated with such an event. The safety zone should have a minimal negative impact on vessel transits in the Pickering Wharf Channel because vessels will be excluded from the area for only one and a half hours, and vessels can still operate in other areas of the channel during the event.

“City of Salem”, the organization responsible for Salem Celebrates the 4th of July, is holding a fireworks display in honor of Independence Day. This rule establishes a temporary safety zone on the navigable waters of the Pickering Wharf Channel within a four hundred (400) yard radius of the fireworks launch site located at approximate position 42°31.05′ N, 070°52.05′ W. This safety zone is necessary to protect the maritime public from the dangers posed by this event. It will protect the public by prohibiting entry into or movement within the proscribed portion of the Pickering Wharf Channel during the fireworks display.

Marine traffic may transit safely outside of the safety zone during the enforcement period. The Captain of the Port does not anticipate any negative impact on vessel traffic due to this event. Public notification will be made prior to and during the effective period via marine information broadcasts and Local Notice to Mariners.

This rule is effective from 8:45 p.m. until 10:15 p.m. on July 4, 2007. Marine traffic may transit safely outside of the safety zone in the majority of the Pickering Wharf Channel during the event. Given the limited time-frame of the enforcement period of the safety zone, the size of the channel and the size of the safety zone itself, the Captain of the Port anticipates minimal negative impact on vessel traffic due to this event. Public notifications will be made prior to and during the enforcement period via Local Notice to Mariners and marine information broadcasts.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order.

Although this rule will prevent traffic from transiting a portion of the Pickering Wharf Channel during this event, the effect of this rule will not be significant for several reasons: vessels will be excluded from the area of the safety zone for only one and one-half hours, although vessels will not be able to transit the channel in the vicinity of the safety zone, they will be able to operate in other areas of the channel during the enforcement period; and advance notification will be made to the local maritime community by marine information broadcasts and Local Notice to Mariners.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule will affect the following entities, some of which may be small entities: the owners or operators of vessels intending to transit or anchor in a portion of the Pickering Wharf Channel from 8:45 p.m. until 10:15 p.m. on July 4, 2007. This safety zone will not have a significant economic impact on a substantial number of small entities for the reasons described under the Regulatory Evaluation section.

Under subsection 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 [Pub. L. 104-121], the Coast Guard wants to assist small entities in understanding this rule so that they can better evaluate its effects on them and participate in the rulemaking process. If this rule will affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please call Petty Officer Joseph Yonker, Sector Boston, Waterways Management Division, at (617) 223-5007.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about the rule or any policy of the Coast Guard.

This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.

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

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

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

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

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

We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies. This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

We have analyzed this rule under Commandant Instruction M16475.lD and Department of Homeland Security Management Directive 5100.1, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (34)(g) of the Instruction, from further environmental documentation. This rule fits the category selected from paragraph (34)(g), as it would establish a safety zone. A final “Environmental Analysis Check List” and a final “Categorical Exclusion Determination” will be available in the docket where indicated under ADDRESSES .

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(3)(B), the Coast Guard finds that good cause exists for not publishing an NPRM. The permit application was not received in time to publish an NPRM followed by a final rule before the effective date. Under 5 U.S.C. 553(d)(3), good cause exists for making this rule effective fewer than 30 days after publication in the Federal Register . Delaying this rule would be contrary to the public interest of ensuring the safety of spectators and vessels during this event and immediate action is necessary to prevent possible loss of life or property.

This temporary safety zone is necessary to ensure the safety of vessels and spectators from hazards associated with a fireworks display. Based on accidents that have occurred in other Captain of the Port zones, and the explosive hazards of fireworks, the Captain of the Port Buffalo has determined fireworks launches proximate to watercraft pose significant risk to public safety and property. The likely combination of large numbers of recreation vessels, congested waterways, darkness punctuated by bright flashes of light, alcohol use, and debris falling into the water could easily result in serious injuries or fatalities. Establishing a safety zone to control vessel movement around the location of the launch platform will help ensure the safety of persons and property at these events and help minimize the associated risks.

A temporary safety zone is necessary to ensure the safety of spectators and vessels during the setup, loading and launching of a fireworks display in conjunction with the Seneca River Days fireworks display. The fireworks display will occur between 9:30 p.m. and 10:30 p.m. on July 6, 2007.

The safety zone for the fireworks will encompass all waters of the Seneca River, Baldwinsville, NY within a six hundred foot radius of position 43°09′25″ N, 076°20′20″ W. [DATUM: NAD 83].

All persons and vessels shall comply with the instructions of the Coast Guard Captain of the Port Buffalo or the designated on-scene representative. Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Buffalo or his designated on-scene representative. The Captain of the Port Buffalo or his designated on-scene representative may be contacted via VHF Channel 16.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order.

This determination is based on the minimal time that vessels will be restricted from the safety zone and the safety zone is an area where the Coast Guard expects insignificant adverse impact to mariners from the safety zone's activation.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

This rule will affect the following entities, some of which may be small entities: The owners and operators of vessels intending to transit or anchor in a portion of the Seneca River Baldwinsville, NY between 9:30 p.m. and 10:30 p.m. on July 6, 2007.

This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons: This rule will be in effect for only one hour for one event. Vessel traffic can safely pass outside the safety zone during the event. In the event that this temporary safety zone affects shipping, commercial vessels may request permission from the Captain of the Port Buffalo to transit through the safety zone. The Coast Guard will give notice to the public via a Broadcast to Mariners that the regulation is in effect.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offered to assist small entities in understanding the rule so that they could better evaluate its effects on them and participate in the rulemaking process. Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about the rule or any policy of the Coast Guard.

This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.

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

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

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

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

The Coast Guard recognizes the treaty rights of Native American Tribes. Moreover, the Coast Guard is committed to working with Tribal Governments to implement local policies and to mitigate tribal concerns. We have determined that this safety zone and fishing rights protection need not be incompatible. We have also determined that this Rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. Nevertheless, Indian Tribes that have questions concerning the provisions of this Proposed Rule or options for compliance are encouraged to contact the point of contact listed under FOR FURTHER INFORMATION CONTACT .

We have analyzed this rule under Executive order 13211, Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a statement of Energy Effects under Executive Order 13211.

The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., specifications of materials, performance, design, or operation; test methods; sampling procedure; and related management system practices) that are developed or adopted by voluntary consensus standards bodies.

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

We have analyzed this rule under Commandant Instruction M16475.lD, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (34)(g), of the Instruction, from further environmental documentation. This event establishes a safety zone therefore paragraph (34)(g) of the Instruction applies.

A final “Environmental Analysis Check List” and a final “Categorical Exclusion Determination” are available in the docket where indicated under ADDRESSES .

Regulatory History

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. As the fireworks display is scheduled to occur on July 4, 2007, any delay encountered in the regulation's effective date would be contrary to the public interest since the safety zone is needed to prevent traffic from transiting a portion of Ipswich Bay during the fireworks display thus ensuring that the maritime public is protected from any potential harm associated with such an event. Additionally, the zone should have negligible impact on vessel transits due to the fact that vessels will be limited from the area for only two hours and vessels can still transit in the majority of Ipswich Bay during the event. Accordingly, under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM.

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

This rule establishes a safety zone on the navigable waters of Ipswich Bay within a 500-yard radius of the fireworks display located at approximate position 42°960.63′ N, 070°77.59′ W. The safety zone is in effect from 8:30 p.m. until 10:30 p.m. on July 4, 2007. The rain date for the fireworks event is from 8:30 p.m. until 10:30 p.m. on July 5, 2007.

The safety zone temporarily restricts movement within this portion of Ipswich Bay and is needed to protect the maritime public from the dangers posed by a fireworks display. Marine traffic may transit safely outside of the safety zone during the enforcement period. The Captain of the Port does not anticipate any negative impact on vessel traffic due to the event. Public notification will be made prior to the enforcement period via marine information broadcasts and Local Notice to Mariners.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order.

Although this rule prevents vessel traffic from transiting a portion of Ipswich Bay during the enforcement period, the effects of this regulation will not be significant for several reasons: Vessels will be excluded from the proscribed area for only two hours, vessels will be able to operate in the majority of Ipswich Bay during the effective period, and advance notification will be made to the local maritime community by marine information broadcasts and Local Notice to Mariners.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

This rule will affect the following entities, some of which may be small entities: the owners or operators of vessels intending to transit or anchor in a portion of Ipswich Bay from 8:30 p.m. until 10:30 p.m. on July 4, 2007. The rain date for the fireworks event is from 8:30 p.m. until 10:30 p.m. on July 5, 2007.

This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons: This rule will be in effect for only two hours, vessel traffic can safely pass around the zone, and advance notification will be made to the local maritime community by marine information broadcasts and Local Notice to Mariners.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offered to assist small entities in understanding the rule so that they could better evaluate its effects on them and participate in the rulemaking process.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.

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

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

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

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

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

We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies.

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

We have analyzed this rule under Commandant Instruction M16475.1D and Department of Homeland Security Management Directive 5100.1, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (34)(g) of the Instruction, from further environmental documentation. This rule fits the category selected from paragraph (34)(g), as it would establish a safety zone.

A final “Environmental Analysis Check List” and a final “Categorical Exclusion Determination” will be available in the docket where indicated under ADDRESSES .

On November 7, 2005, the Postal Service published a proposed rule in the Federal Register (70 FR 67399-67405), soliciting comments from mailers and parcel shippers on requiring the use of the Electronic Verification System (eVS) for all permit imprint Parcel Select mailings, including those containing authorized commingled Standard Mail machinable parcels and parcels from the other subclasses of Package Services (Bound Printed Matter, Media Mail, and Library Mail).

On July 10, 2006, the Postal Service published a final rule in the Federal Register (71 FR 38966-38978) responding to comments from the mailing industry and providing implementing language and mailing standards to take effect on August 1, 2007, that would require all permit imprint Parcel Select mail and all permit imprint mail authorized to be commingled with Parcel Select to be prepared using eVS.

The Postal Service is delaying the required use of eVS because of the large number of format and coding changes required by the R2006-1 omnibus rate case, implemented on May 14, 2007, and because of the addition of several new subclasses of mail that will become available under eVS after May 14, 2007.

As a result, the Postal Service is re-evaluating a suitable date for new mailer implementation of eVS. Once the Postal Service, working closely with the parcel shipping industry, determines an appropriate date, it will publish the new date in the Federal Register and the Postal Bulletin.

We adopt the following amendments to Mailing Standards of the United States Postal Service, Domestic Mail Manual (DMM), incorporated by reference in the Code of Federal Regulations. See 39 CFR 111.1.

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT .

In addition to accessing an electronic copy of this Federal Register document through the electronic docket at http://www.regulations.gov , you may access this “ Federal Register ” document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr . You may also access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr . To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm .

Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2006-0313 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before August 27, 2007.

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2006-0313, by one of the following methods.

• Federal eRulemaking Portal : http://www.regulations.gov . Follow the on-line instructions for submitting comments.

• Mail : Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

• Delivery : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305-5805.

In the Federal Register of July 7, 2006 (71 FR 38643) (FRL-8069-7), EPA issued a notice pursuant to section 408(d)(3) of the FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 6E7029) by BioProdex, Inc., Gainesville Technology Enterprise Center (GTEC), Box 5, Suite 205, 2153 SE Hawthorne Road, Gainesville, FL 32641. The petition requested that 40 CFR part 180 be amended by establishing a temporary exemption from the requirement of a tolerance for residues of TMGMV. The docket for this action includes a summary of the petition prepared by the petitioner IR-4 on behalf of BioProdex, Inc. There were no comments received in response to the notice of filing.

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

EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, EPA determines the toxicity of pesticides. Second, EPA examines exposure to the pesticide through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings.

Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

TMGMV is a tobamovirus, a type of plant virus, and tobamoviruses have no known toxicity or pathogenicity to any organisms other than plants. They are unable to infect animals because they lack cell surface binding site receptors common to animal viruses. Tobamoviruses enter plant cells only through open wounds (e.g., those produced by feeding insects or by mechanical methods) or by cell-to-cell transfer (Fraenkel-Conrat, et. al ., 1988). Almost all living things are routinely exposed to plant viruses, including tobamoviruses, through plants and plant products (e.g., foods). TMGMV is known to infect about 20 plants, including peppers (Plant Viruses Online, 2005; Wetter, C., 2005); therefore, humans are likely already exposed to TMGMV through food. Throughout the available literature, there are no reports of adverse effects in animals resulting from ingestion or exposure to TMGMV. TMGMV has not been reported to multiply in insects nor in any other known animal. One reference provided by the registrant may show replication of TMV (another tobamovirus) in cultured, immune-suppressed, monkey kidney cell lines (Atherton, J.G., 1968). However, this was an artificial system and does not indicate that plant viruses can normally replicate in animal cells. The specific mode of action of TMGMV is such that only some species within the plant family Solanaceae are susceptible to this virus. Laboratory animals such as rabbits, mice, chickens, and guinea pigs are routinely used for producing antibodies against tobamoviruses without causing adverse effects to the animals. In addition, there are no reports of humans that handle and administer the viruses or of these laboratory animals developing any nasal, eye, skin, or pulmonary allergies, or any other adverse reactions to the viruses.

In support of this tolerance exemption, mammalian toxicology requirements were satisfied by publicly available information submitted by BioProdex, summarized in the paragraph above. Specifically, the information provided supports the lack of toxicity to mammals and humans of tobamoviruses, the fact that only certain plants (and no animals) are susceptible to TMGMV, and that TMGMV poses little to no risk to humans.

1. Acute oral toxicity/pathogenicity (OPPTS 885.3050) . To satisfy this requirement, the registrant submitted supporting public literature rather than a study, which shows that plant viruses, including TMGMV, are found in food ingested daily by humans and animals, and according to the published literature, no known adverse effects or deaths have occurred in any species as a result of such dietary exposures.

2. Acute dermal toxicity/pathology (OPPTS 885.3100) . The registrant submitted supporting public literature rather than a study to fulfill this requirement, showing that plant viruses, including TMGMV, are ubiquitous in plants, and they are not known to cause acute dermal toxicity or pathogenicity to mammals.

3. Acute eye irritation (OPPTS 870.2400) . The registrant submitted supporting public literature rather than a study to fulfill this requirement, showing that plant viruses, including TMGMV, are ubiquitous in plants, and they are not known to cause acute eye irritation or pathogenicity to mammals.

4. Acute pulmonary toxicity/pathogenicity (OPPTS 885.3150) . To fulfill this requirement, the registrant submitted supporting public literature rather than a study, which shows that plant viruses, including TMGMV, are ubiquitous in plants, and they are not known to cause acute pulmonary toxicity or pathogenicity to mammals.

5. Acute injection toxicity/pathogenicity (OPPTS 885.3200) . To fulfill this requirement, the registrant submitted supporting public literature rather than a study, showing the following:

i. TMGMV, like all tobamoviruses, can evoke immune responses and produce antibodies if properly injected into laboratory animals such as rabbits, mice, chickens, and guinea pigs without causing adverse effects to the animals; and

ii. There are no reports of humans that handle and administer tobamoviruses or laboratory animals developing adverse reactions to the virus.

6. Hypersensitivity incidents (OPPTS 885.3400) . Workers handling TMGMV on a daily basis since 1999 have not had a single incidence of hypersensitivity. In addition, some workers have been handling tobamoviruses for nearly 40 years without encountering hypersensitivity to any of these viruses. There are no reports of hypersensitivity in humans or other animals to tobamoviruses in the literature.

7. Cell culture (OPPTS 885.3500) . To satisfy this requirement, the registrant submitted the following information, supported by public literature. Tobamoviruses are unable to infect animal cells since the cell surface plays an important role in infection of animal cells; during infection, animal viruses interact specifically with receptors on the animal cell surface. Tobamoviruses, on the other hand, lack recognition for these receptors and only enter plant cells through open wounds or via cell-to-cell transfer through intercellular connections (Fraenkel-Conrat, et. al ., 1988). There is one report in the literature of growing Tobacco mosaic tobamovirus (TMV; a different tobamovirus from the one that is the subject of this tolerance exemption) in cultured, immune-suppressed, monkey kidney cell lines (Atherton, J.G., 1968). However, this was an artificial system and does not indicate that tobamoviruses can normally replicate in or infect animal cells.

Based on the published literature, in accordance with Tier I toxicology data requirements set forth in 40 CFR 158.740(c), the Tier II and Tier III toxicology data requirements were not triggered in connection with this action.

In examining aggregate exposure, section 408 of the FFDCA directs EPA to consider available information concerning exposures from the pesticide residue in food and all other non-occupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses).

1. Food . Virus-infected food plants have always been a part of the human and domestic animal food supply (Dewan and Pearson, 1995; McKinney, 1929; Provvidenti and Gonsalves, 1984; Palukaitis, 1991; Jones et al., 1934; Beemster and de Bokx, 1987). Most plants may be infected by at least one virus, and components of plant viruses are often found in the produce of crop plants. Even plants that show no disease symptoms are often found to be infected with viruses (Jones et al ., 1934; Fulton, 1986). In addition, a common agricultural practice used since the 1920s for protection against viral disease involves intentionally inoculating healthy plants with a mild form of a virus in order to prevent infection by a more virulent form (Fulton, 1986). A great deal of information supports the ubiquitous appearance of plant viruses in foods, and to date there have been no reports of adverse human or animal health effects associated with consumption of plant viruses in food. Furthermore, the proposed experimental use permit (EUP) is not expected to result in increased exposures of TMGMV to the general population: The intended use of TMGMV is in rangelands, grass pastures, sod-production fields, Conservation Reserve areas, and other natural areas in Florida, and the only residues anticipated on food with this EUP are on grass and grass hay. In addition, these residues on grass or grass hay would only be incidental to application to the target organism since grass is not a host for TMGMV; therefore, TMGMV cannot infect grass or replicate in grass. Accordingly, the Agency concludes that when TMGMV is used as intended, there is reasonable certainty that no harm will result to humans from all anticipated exposures through food to any residues resulting from such use.

2. Drinking water exposure . TMGMV is not intended for use in drinking water. However, in the event that TMGMV would reach water consumed by humans, for the reasons enumerated above, the Agency concludes that when TMGMV is used as intended, there is reasonable certainty that no harm will result to humans from all anticipated exposures through water to any residues resulting from such use.

EPA concludes that dermal or inhalation exposure to the general population as a result of this EUP is not likely to occur, based on the proposed uses and limited acreage. Moreover, the general population, including infants and children, are exposed to plant viruses daily in food with no known adverse effects ever being reported. Therefore, the Agency concludes that in the unlikely event that there is non-occupational, non-dietary exposure to TMGMV, such exposure would pose no risks to the general population, including infants and children.

Section 408(b)(2)(D)(v) of the FFDCA requires that EPA consider available information on the cumulative effects of a particular pesticide's residues and other substances that have a common mechanism of toxicity when establishing, modifying, or revoking a tolerance. These considerations include the possible cumulative effects on infants and children of such residues and other substances with a common mode of toxicity. Because there is no indication of mammalian toxicity or pathogenicity from TMGMV, we conclude that there are no cumulative effects for this virus and any other substance.

1. U.S. population . For all of the reasons discussed above, there is reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of TMGMV. This includes all anticipated dietary exposures and all other exposures for which there is reliable information.

2. Infants and children . Section 408(b)(2)(C) of the FFDCA provides that EPA shall apply an additional tenfold margin of exposure (MOE) for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base on toxicity and exposure, unless EPA determines that a different MOE will be safe for infants and children. MOEs, which are often referred to as uncertainty (safety) factors, are incorporated into EPA risk assessments either directly, or through the use of a MOE analysis or by using uncertainty factors in calculating a dose level that poses no appreciable risk. As previously mentioned in the toxicological profile, humans, including infants and children, have been exposed to plant viruses through food, where they are commonly found, with no known or reported adverse effects. As discussed above, the Agency has concluded that TMGMV is non-toxic to mammals, including infants and children. Because there are no threshold levels of concern to infants, children, and adults when TMGMV is used as labeled, the Agency concludes that the additional MOE is not necessary to protect infants and children.

At this time, the Agency is not requiring information on the endocrine effects of this active ingredient, TMGMV. The Agency has considered, among other relevant factors, available information concerning whether the virus may have an effect in humans similar to an effect produced by a naturally occurring estrogen or other endocrine effects. Plant viruses cannot infect mammals, and there is no known metabolite that acts as an “endocrine disruptor” produced by this virus. Therefore, there is no impact via endocrine-related effects on the Agency's safety findings in this final rule.

Through this action, the Agency is proposing to establish a temporary exemption from the requirement of a tolerance for residues of TMGMV on grass and grass hay for the purposes of an EUP. The Agency reached this decision based on the reasons discussed above, including lack of toxicity to mammals, and therefore concludes that an analytical method for detecting TMGMV is not required for enforcement purposes.

No Codex maximum residue levels exist for the virus TMGMV.

1. Atherton, J.G. 1968. Formation of tobacco mosaic virus in an animal cell culture. Archiv fur die gesamte Virusforschung 24:406-418.

2. Beemster ABR, de Bokx JA. Survey of properties and symptoms. In: de Bokx JA, van der Want JPH. Viruses of Potatoes and Seed Potato Production. Wageningen: Pudoc, 1987:84-93.

3. Dewan C, Pearson MN. Natural field infection of garlic by garlic yellow streak virus in the Pukekohe area of New Zealand and associated problems with the introduction of new garlic cultivars. New Zealand Journal of Crop and Horticultural Science 1995; 23:97-102.

4. Fraenkel-Conrat, H., Kimball, P.C., and Levy, J.A. 1988. Virology, 2nd edition. Prentice Hall, Englewood Cliffs, NJ (Virus cellular receptors and cell membrane changes, p. 299-300).

5. Fulton R. Practices and precautions in the use of cross protection for plant virus disease control. Annual Review of Phytopathology 1986; 24:67-81.

6. Jones L, Anderson E, Burnett G. The latent virus of potatoes. Journal of Phytopathology 1934; 7:93-115.

7. McKinney HH. Mosaic diseases in the Canary Islands, West Africa, and Gibraltar. Journal of Agricultural Research 1929; 39:557-78.

8. Palukaitis P. Virus-mediated genetic transfer in plants. In: Levin M, Strauss H. Risk Assessment in Genetic Engineering. New York: McGraw-Hill, 1991:140-62.

9. Provvidenti R, Gonsalves D. Occurrence of zucchini yellow mosaic virus in cucurbits from Connecticut, New York, Florida, and California. Plant Disease 1984; 68:443-6.

10. Palukaitis P. Virus-mediated genetic transfer in plants. In: Levin M, Strauss H. Risk Assessment in Genetic Engineering. New York: McGraw-Hill, 1991:140-62.

11. Plant Viruses Online, 2005. http://image.fs.uidaho.edu/vide/descr801.htm .

12. Wetter, C., 2005. Tobacco mild green mosaic virus. In: AAB Description of Plant Viruses No. 35. http://www.dpvweb.net/dpv/showdpv.php?dpvno=351 .

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

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

This final rule directly regulates growers, food processors, food handlers and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000) do not apply to this rule. In addition, This rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).

The Congressional Review Act, 5 U.S.C. 801 et seq ., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report 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 this final rule in the Federal Register . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to those engaged in the following activities:

• Crop production (NAICS code 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers.

• Animal production (NAICS code 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers.

• Food manufacturing (NAICS code 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators.

• Pesticide manufacturing (NAICS code 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users.

This listing is not intended to be exhaustive, but rather to provide a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT .

In addition to accessing an electronic copy of this Federal Register document through the electronic docket at http://www.regulations.gov , you may access this Federal Register document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr . You may also access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr .

Under section 408(g) of the FFDCA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2006-0821 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 on or before August 27, 2007.

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit this copy, identified by docket ID number EPA-HQ-OPP-2006-0821, by one of the following methods:

• Federal eRulemaking Portal : http://www.regulations.gov . Follow the on-line instructions for submitting comments.

• Mail : Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

• Delivery : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305-5805.

In the Federal Register of October 11, 2006 (71 FR 59781) (FRL-8098-1), EPA issued a notice pursuant to section 408(d)(3) of the FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 5E6979, 5E6980 and 5E6981) by Interregional Research Project Number 4 (IR-4), 681 U.S. Highway #1 South, North Brunswick, NJ 08902-3390. The petitions requested that 40 CFR 180.511 be amended by establishing a tolerance for residues of the insecticide buprofezin, 2-[(1,1-dimethylethyl)imino]tetrahydro-3(1- methylethyl)-5-phenyl-4H-1,3,5-thiadiazin-4-one, in or on fruit, stone, group 12 (except peaches and nectarines) at 2 parts per million (ppm) (5E6979); black sapote, canistel, mamey sapote, mango, papaya, sapadilla and star apple at 0.8 ppm (5E6980); and amending the tolerances in or on grape at 0.8 ppm and grape, raisin at 1.2 ppm (5E6981). That notice referenced a summary of the petition prepared by Ninchino America, Inc., the registrant, which is available to the public in the docket, http://www.regulations.gov . There were no comments received in response to the notice of filing.

Based upon review of the residue field trial data supporting the petitions, EPA has modified the proposed tolerances as follows: Fruit, stone, group 12, except apricot and peach at 1.9 ppm; apricot at 9.0 ppm (PP5E6979); black sapote, canistel, mamey sapote, mango, papaya, sapadilla and star apple at 0.90 ppm (PP5E6980); and grape at 2.5 ppm with deletion of the existing tolerance on grape, raisin, since a separate raisin tolerance is no longer needed (PP5E6981). The reason for these changes is explained in Unit V.

Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of the FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of the FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue....” These provisions were added to the FFDCA by the Food Quality Protection Act (FQPA) of 1996.

Consistent with section 408(b)(2)(D) of the FFDCA, and the factors specified in section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for the petitioned-for tolerances for residues of buprofezin on fruit, stone, group 12, except apricot and peach at 1.9 ppm; apricot at 9.0 ppm; black sapote, canistel, mamey sapote, mango, papaya, sapodilla and star apple at 0.90 ppm; and grape at 2.5 ppm. EPA's assessment of exposures and risks associated with establishing the tolerances follows.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the adverse effects caused by buprofezin as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are discussed in the final rule published in the Federal Register of September 5, 2001 (66 FR 46381), (FRL-6796-6).

For hazards that have a threshold below which there is no appreciable risk, the toxicological level of concern (LOC) is derived from the highest dose at which no adverse effects are observed (the NOAEL) in the toxicology study identified as appropriate for use in risk assessment. However, if a NOAEL cannot be determined, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment. Uncertainty/safety factors (UF) are used in conjunction with the LOC to take into account uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the acute population adjusted dose (“aPAD”) and chronic population adjusted dose (“cPAD”). The aPAD and cPAD are calculated by dividing the LOC by all applicable uncertainty/safety factors. Short-term, intermediate-term, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the margin of exposure (“MOE”) called for by the product of all applicable uncertainty/safety factors is not exceeded.

For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk and estimates risk in terms of the probability of occurrence of additional adverse cases. Generally, cancer risks are considered non-threshold. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm .

A summary of the toxicological endpoints for buprofezin used for human risk assessment can be found at www.regulations.gov in document “Buprofezin - Human-Health Risk Assessment for the Requested Stone Fruit Registration and the Proposed Amendment for the Grape and Papaya and Related Tropical Fruit Registrations” at pages 9-10 in Docket ID EPA-HQ-OPP-2006-0821.

1. Dietary exposure from food and feed uses . In evaluating dietary exposure to buprofezin, EPA considered exposure under the petitioned-for tolerances as well as all existing buprofezin tolerances in 40 CFR 180.511. EPA assessed dietary exposures from buprofezin in food as follows:

i. Acute exposure . Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. Such effects were identified in the toxicological studies for buprofezin for the population subgroup, females 13-50 years old; no such effects were identified for the general population or other population subgroups. In estimating acute dietary exposure of females 13-50 years old, EPA used food consumption information from the United States Department of Agriculture (USDA) 1994-1996 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA assumed that residues are present at tolerance levels for all commodities except meat and milk. Anticipated residues were calculated for meat and milk commodities as follows: Tolerances for meat and milk are established at the analytical method limit of quantitation (LOQ). Since residues were only detected in the livestock feeding study when feed contained 6.8-9.3x the maximum theoretical dietary burden (MTDB), residues in these commodities were normalized to 1x the MTDB in the acute dietary exposure assessment. For fruits and crops with an extended interval from initial application to harvest (>50 day), additional metabolites of toxicological concern (BF4 and its conjugates, and BF12) that are not included in the tolerance expression were included in the dietary exposure assessment, as appropriate, based on the ratio of metabolite to parent found in plant metabolism studies. No adjustment was made to account for the percent of crops treated with buprofezin in the acute dietary exposure assessment. One hundred (100) percent crop treated (PCT) was assumed for all commodities.

ii. Chronic exposure . In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA relied upon anticipated residues and percent crop treated information for some commodities. The chronic analysis employed the same anticipated residue estimates for meat and milk as those employed for the acute analysis. For apple, orange, and orange juice, average residues from the 2004 and/or 2005 USDA Pesticide Data Program (PDP) monitoring data were used for estimation of total buprofezin and metabolite residues. For all other plant commodities, tolerance-level or average field trial residues were used. For fruits and crops with an extended interval from initial application to harvest (>50 day), additional metabolites of toxicological concern (BF4 and its conjugates, and BF12) that are not included in the tolerance expression were included in the dietary exposure assessment, as appropriate, based on the ratio of metabolite to parent found in plant metabolism studies. The chronic analysis incorporated screening-level percent crop treated estimates for several registered crops and projected percent crop treated estimates for peach, grape, apricot, nectarine, cherry, and plum. 100 PCT was assumed for commodities for which PDP monitoring data were used to estimate exposures (apple, orange, and orange juice).

iii. Cancer . Taking into account its Guidelines for Carcinogen Risk Assessment, EPA classified buprofezin as having suggestive evidence of carcinogenicity, based on the occurrence of liver tumors in female mice only. EPA determined, however, that no quantification of cancer risk was appropriate, because the evidence was limited to one sex of one species. Therefore, a quantitative cancer exposure and risk assessment was not conducted.

iv. Anticipated residue and PCT information . Section 408(b)(2)(E) of the FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must pursuant to section 408(f)(1) require that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. For the present action, EPA will issue such data call-ins as are required by section 408(b)(2)(E) of the FFDCA and authorized under section 408(f)(1) of the FFDCA. Data will be required to be submitted no later than 5 years from the date of issuance of this tolerance.

Section 408(b)(2)(F) of the FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if:

a. The data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain such pesticide residue;

b. The exposure estimate does not underestimate exposure for any significant subpopulation group; and

c. Data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area. In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by section 408(b)(2)(F) of the FFDCA, EPA may require registrants to submit data on PCT.

The Agency used PCT information as follows:

PCT for existing uses: Almond 1%; cantaloupe 5%; citrus (citron, hybrids and oil) 1%; cottonseed 1%; grapefruit 1%; honeydew 1%; lemon 1%; lime 1%; orange peel 1%; pear 1%; pumpkin 1%; tomato 1%; and watermelon 1%. Projected PCT for New Uses: Apricot 40%; cherry 76%; grape 21%; nectarine 60%; peach 13%; and plum 35%.

EPA uses an average PCT for chronic dietary risk analysis. The average PCT figure for each existing use is derived by combining available federal, state, and private market survey data for that use, averaging by year, averaging across all years, and rounding up to the nearest multiple of five percent except for those situations in which the average PCT is less than one. In those cases <1% is used as the average and <2.5% is used as the maximum. EPA uses a maximum PCT for acute dietary risk analysis. The maximum PCT figure is the single maximum value reported overall from available federal, state, and private market survey data on the existing use, across all years, and rounded up to the nearest multiple of five percent. In most cases, EPA uses available data from USDA/National Agricultural Statistics Service (USDA/NASS), Proprietary Market Surveys, and the National Center for Food and Agriculture Policy (NCFAP) for the most recent six years.

EPA estimates projected percent crop treated (PPCT) for a new pesticide use by assuming that the PCT during the pesticide's initial five years of use on a specific use site will not exceed the average PCT of the market leader (i.e., the one pesticide with the greatest PCT) on that site.

Typically, EPA uses USDA/NASS as the primary source for PCT data. When a specific use site is not surveyed by USDA/NASS, EPA uses other sources including proprietary data and calculates the PCT. Comparisons are only made among pesticides of the same pesticide types (i.e., the leading insecticide on the use site is selected for comparison with the new insecticide). The chronic PPCT values for buprofezin are averages derived from the most recent NASS surveys, either for the same pesticide, or for different pesticides, since the same, or different, pesticides may dominate for each year selected. This PPCT, based on the average PCT of the market leader, is appropriate for use in chronic dietary risk assessment. The method of estimating a PPCT for a new use of a registered pesticide or a new pesticide produces a high-end estimate that is unlikely, in most cases, to be exceeded during the initial five years of actual use.

The predominant factors that bear on whether the estimated PPCT could be exceeded are whether a new pesticide use or new pesticide is more efficacious or controls a broader spectrum of pests than the dominant pesticide; and/or whether increasing pest pressure may intensify the use of pesticides as indicated in emergency exemption requests or other readily available information.

All information currently available for the predominant factors mentioned above or relevant to the case in question have been considered for this chemical, and it is the opinion of EPA that it is unlikely that actual PCT for buprofezin will exceed the PCT projections during the next five years. A discussion of the factors considered in making this determination can be found at www.regulations.gov in the document “Projected Percent Crop Treated for the Insecticide Buprofezin on Six Crops: Grapes, Apricots, Nectarines, Sweet Cherries, Tart Cherries, and Plums”, which is attached to the document “Buprofezin - Acute and Chronic Dietary Exposure and Risk Assessments” at pages 13-17 in Docket ID EPA-HQ-OPP-2006-0821.

The Agency believes that the three conditions listed above have been met. With respect to Condition 1, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions 2 and 3, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available information on the regional consumption of food to which buprofezin may be applied in a particular area.

2. Dietary exposure from drinking water . The Agency lacks sufficient monitoring data to complete a comprehensive dietary exposure analysis and risk assessment for buprofezin in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the environmental fate characteristics of buprofezin. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm .

Based on the EPA's Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-GROW) models, the estimated environmental concentrations (EECs) of buprofezin for acute exposures are estimated to be 23.2 parts per billion (ppb) for surface water and 0.1 ppb for ground water. The EECs for chronic exposures are estimated to be 7.8 ppb for surface water and 0.1 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 23.2 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 7.8 ppb was used to assess the contribution to drinking water.

3. From non-dietary exposure . The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets).

Buprofezin is not registered for use on any sites that would result in residential exposure.

4. Cumulative effects from substances with a common mechanism of toxicity . Section 408(b)(2)(D)(v) of the FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to buprofezin and any other substances and buprofezin does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that buprofezin has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative .

1. In general . Section 408 of the FFDCA provides that EPA shall apply an additional (“10X”) tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA safety factor. In applying this provision, EPA either retains the default value of 10X when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional FQPA safety factor value based on the use of traditional uncertainty/safety factors and/or special FQPA safety factors, as appropriate.

2. Prenatal and postnatal sensitivity . There is no quantitative or qualitative evidence of increased susceptibility of rat or rabbit fetuses to in utero exposure to buprofezin in developmental studies. There is no quantitative or qualitative evidence of increased susceptibility of rat offspring in the 2-generation reproduction study. There is evidence of thyroid toxicity following subchronic and chronic exposures of rats and dogs to buprofezin; however, data to determine whether young animals are more susceptible to these effects are not available.

3. Conclusion . EPA has determined that, due to uncertainties in the toxicity database for buprofezin, the FQPA safety factor of 10X must be retained and applied to all subchronic and chronic exposures whose endpoint is based on thyroid effects. EPA has also determined that the traditional 10X uncertainty factor to account for interspecies variation may be reduced to 3X for these exposures. For acute exposures, EPA has determined that the FQPA safety factor may be reduced to 1X and that the tradiditonal 10X safety factor to account for interspecies variation must be retained. These decisions are based on the following findings:

i. The toxicity database for buprofezin is not complete as to chronic risk. Based on the evidence of thyroid toxicity following subchronic and chronic exposures of rats (histopathological lesions) and dogs (decreases in serum thyroxine levels and increased thyroid weights), EPA requested a buprofezin comparative thyroid assay study in rats (28-day; young versus adults) to determine if the thyroid effects occur at a lower dose in young versus adult animals. Since this study has not been submitted, EPA concludes that the 10X FQPA safety factor to account for database uncertainty should be retained and applied to all subchronic and chronic exposures whose endpoint is based on thyroid effects. EPA has also determined that the traditional 10X uncertainty factor to account for interspecies variation may be reduced to 3X for these exposures, since it has been established that rats are more susceptible to thyroid effects than humans. The FQPA safety factor of 10X is not applicable to the acute endpoint, since a single dose of buprofezin would not be expected to perturb thyroid homeostasis in the adult or the young due to the buffering of thyroid hormone concentrations by homeostatic mechanisms for compounds with short half lives, like buprofezin.

ii. There is no indication that buprofezin is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional uncertainty factors to account for neurotoxicity.

iii. There is no evidence that buprofezin results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study.

iv. There are no residual uncertainties in the exposure databases. The dietary food exposure assessments were refined for some commodities using reliable PCT/PPCT information and anticipated residue values calculated from the available monitoring data and field trial results. Dietary drinking water exposure is based on conservative modeling estimates. These assessments will not underestimate the exposure and risks posed by buprofezin.

Therefore, the total uncertainty factor for chronic dietary assessments is 300X (10X FQPA safety factor, 3X uncertainty factor for interspecies variation, and 10X uncertainty factor for intraspecies variation); and the total uncertainty factor for acute dietary assessments is 100X (10X uncertainty factor for interspecies variation and 10X uncertainty factor for intraspecies variation).

Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the acute population adjusted dose (“aPAD”) and chronic population adjusted dose (“cPAD”). The aPAD and cPAD are calculated by dividing the LOC by all applicable uncertainty/safety factors. For linear cancer risks, EPA calculates the probability of additional cancer cases given aggregate exposure. Short-term, intermediate-term, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the MOE called for by the product of all applicable uncertainty/safety factors is not exceeded.

1. Acute risk . Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to buprofezin will occupy 6% of the aPAD for the population group females 13-49 years old. No acute endpoint of concern was identified for the remaining population groups.

2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to buprofezin from food and water will utilize 92% of the cPAD for the population group (children 1 to 2 years old) with the greatest exposure. There are no residential uses for buprofezin that result in chronic residential exposure to buprofezin.

3. Short-term risk . Short-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

Buprofezin is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water.

4. Intermediate-term risk . Intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

Buprofezin is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which does not exceed the Agency's LOC.

5. Aggregate cancer risk for U.S. population . Buprofezin is classified as having suggestive evidence of carcinogenicity; however, EPA determined it poses a negligible cancer risk to humans because the evidence of carcinogenicity was limited to one sex of one animal test species only.

6. Determination of safety . Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to buprofezin residues.

The gas chromatography/nitrogen phosphorus detector methods used in the field trial studies were adequately validated and similar to the method validated by EPA's Analytical Chemistry Branch (ACB) and forwarded to the Food and Drug Administration for publication in the Pesticide Analytical Manual I. Since adequate method validation and concurrent recoveries were attained in the field trial studies, EPA concludes that the method validated by ACB is appropriate for enforcement of the tolerances associated with these petitions. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address: residuemethods@epa.gov .

There are no Canadian, Mexican, or Codex maximum residue limits (MRLs) established for buprofezin in/on any of the commodities associated with the current petitions.

Based upon review of the data supporting the petitions, EPA has modified the proposed tolerances as follows: Fruit, stone, group 12, except apricot and peach at 1.9 ppm; apricot at 9.0 ppm (PP5E6979); black sapote, canistel, mamey sapote, mango, papaya, sapadilla and star apple at 0.90 ppm (PP5E6980); and grape at 2.5 ppm with deletion of the existing tolerance on grape, raisin (PP5E6981). EPA determined that the proposed tolerances for these commodities were inappropriate and should be revised based on analyses of the residue field trial data using the Agency's Tolerance Spreadsheet in accordance with the Agency's Guidance for Setting Pesticide Tolerances Based on Field Trial Data Standard Operating Procedure (SOP). Tolerances currently exist for residues of buprofezin in or on grape at 0.4 ppm and grape, raisin at 0.6 ppm. Based upon review of field trial data supporting the current petition and previously submitted processing data for buprofezin on grapes, EPA has determined that residues in raisins will not exceed the tolerance being established for residues of buprofezin in or on grape at 2.5 ppm. Since a separate tolerance for raisins is not needed and the existing raisin tolerance is too low to cover residues of buprofezin from the new use on grapes, EPA is deleting the existing tolerance for grape, raisin. Residues in or on raisins will be covered by the tolerance of 2.5 ppm for grape.

Therefore, tolerances are established for residues of buprofezin, 2-[(1,1-dimethylethyl)imino] tetrahydro-3(1-methylethyl)-5-phenyl-4H-1,3,5-thiadiazin-4-one, in or on fruit, stone, group 12, except apricot and peach at 1.9 ppm; apricot at 9.0 ppm; black sapote, canistel, mamey sapote, mango, papaya, sapadilla and star apple at 0.90 ppm; and grape at 2.5 ppm. The existing tolerance for residues of buprofezin in or on grape, raisin is deleted.

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

Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of the FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq .) do not apply. This final rule directly regulates growers, food processors, food handlers and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of the FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000) do not apply to this rule. In addition, This rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).

The Congressional Review Act, 5 U.S.C. 801 et seq. , generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report 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 this final rule in the Federal Register . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).

Relocation is an area that continuously evolves because of changes in the housing market, transportation industry, technology, etc. The General Services Administration (GSA), Office of Governmentwide Policy (OGP), routinely reviews the relocation regulations to address current Government relocation needs, to incorporate appropriate private industry policies, and to implement any best practices that fit well into the Federal setting.

To help accomplish these goals, GSA created the Relocation Best Practices Committee (RBPC) in 2002. Many of this Committee's recommendations were reflected in a proposed rule published in the Federal Register at 69 FR 68111, November 23, 2004.

The proposed rule included 30 changes; however, this final rule focuses on only one of those proposed changes, namely adopting the mileage rate established by the IRS for computing relocation, or moving, costs for income tax purposes for reimbursing Federal employees for using their POVs for relocation travel to a new duty station for PCS. GSA will address the remaining Federal Travel Regulation (FTR) changes from the proposed rule in one or more future final rule(s).

Section 302-4.300 of the FTR (41 CFR 302-4.300) currently provides tiered reimbursements for POV use in en route travel to the new duty station based on the number of occupants. This final rule will eliminate the tiered rates. Instead, the agency will reimburse the employee who relocates by POV at the established IRS rate for use of a car for moving purposes. GSA will publish this rate in an FTR Bulletin to coincide with updates issued by the IRS. The IRS generally issues such updates annually, but for special cases, such as Hurricane Katrina, the IRS may issue updates during the year and GSA will follow suit.

The IRS allows two methods for computing the standard mileage rates for use of a car in moving: a single mileage rate or actual expense. GSA has decided to allow only reimbursement at the single mileage rate, since this approach is easier to administer and does not involve collecting and auditing small value receipts.

Many transferees compare the reimbursement rate for using a POV for temporary duty travel (TDY) to the rate for using a POV for relocation travel and do not understand why those rates differ. The more generous rate for using a POV for TDY travel is intended to cover the fixed costs of operating an automobile, such as depreciation (or lease payments), insurance, and license and registration fees, as well as the operating cost. None of these fixed costs are tax deductible as a moving expense, so none of these fixed costs are included in the moving rate mileage calculation. The IRS intends the rate for using a POV in moving to cover only actual operating expenses ( e.g. , fuel, oil, tolls, etc.). The IRS then uses the operating costs for a combination of standard vehicles to calculate the moving rate.

GSA consulted the members of the Executive Relocation Steering Committee about this change. All members agreed that this adoption of the single IRS rate is appropriate.

GSA received comments from 12 entities on the proposed mileage rate change that was included in the proposed rule published in the Federal Register at 69 FR 68111, November 23, 2004. The main thrust of the comments was that payments to employees driving their automobiles should not be lowered. This argument was valid in 2004, at the time the proposed rule was issued. The IRS rate for using an automobile for relocation at that time was 14 cents per mile, which was lower than any rate on the FTR chart. The IRS rate for 2007 will be 20 cents per mile, which means that all drivers regardless of the number of passengers, will be receiving the equivalent of the highest possible rate in the current regulation.

Another objection to the proposed rule was that small agencies or isolated posts might not receive the GSA updates on the mileage rate. This has not been the case for the TDY mileage rate. Agencies adopt the TDY mileage rate quickly and accurately when it changes. GSA expects this to be the same for the relocation mileage rate.

This final rule:

• Revises section 302-4.300 to reflect the Internal Revenue Service single mileage rate for relocation by POV.

• Adds section 302-4.303 to disallow the use of the IRS actual expense rate for relocation in CONUS.

This regulation is excepted from the definition of “regulation” or “rule” under Section 3(d)(3) of Executive Order 12866, Regulatory Planning and Review, dated September 30, 1993 and, therefore, was not subject to review under Section 6(b) of that executive order.

This final rule is not required to be published in the Federal Register for notice and comment; therefore, the Regulatory Flexibility Act, 5 U.S.C. 601, et seq. , does not apply.

The Paperwork Reduction Act does not apply because the changes to the FTR do not impose recordkeeping or information collection requirements, or the collection of information from offerors, contractors, or members of the public that require the approval of the Office of Management and Budget under 44 U.S.C. 3501, et seq.

This final rule is also exempt from congressional review prescribed under 5 U.S.C. 801 since it relates solely to agency management and personnel.

This is a summary of the Commission's Order ; FCC 07-115, adopted June 18, 2007, and released June 20, 2007. The full text of this document is available for inspection and copying during normal business hours in the FCC Reference Center, 445 12th Street, SW., Washington, DC 20554. The complete text may be purchased from the Commission's copy contractor, Best Copy and Printing, Inc., 445 12th Street, SW., Room CY-B402, Washington, DC 20554. The full text may also be downloaded at: http://www.fcc.gov. Alternative formats are available to persons with disabilities by sending an e-mail to fcc504@fcc.gov or by calling the Consumer & Governmental Affairs Bureau at 202-418-0530 (voice), 202-418-0432 (tty).

By an Order published at 66 FR 62991, December 4, 2001, the Commission amended its procedural rules “on an emergency, interim basis” to permit certain pleadings (specifically, (i) Petitions to deny filed pursuant to section 309 of the Communications Act of 1934, as amended (Act), 47 U.S.C. 309; (ii) petitions for reconsideration filed pursuant to section 405 of the Act, 47 U.S.C. 405; (iii) applications for review filed pursuant to section 5(c)(4) of the Act, 47 U.S.C. 155(c)(4); (iv) informal requests for Commission action involving pending applications filed pursuant to § 1.41 of the Commission's rules, 47 CFR 1.41; (v) petitions to amend the TV and FM Broadcast Table of Allotments and responsive pleadings; and (vi) comments or oppositions to open video system certification made pursuant to § 76.1502(e)(1) of the Commission's rules, 47 CFR 76.1502(e)(1)) to be filed electronically ( i.e. , by facsimile or e-mail) “[u]ntil further notice.” It adopted these procedures in response to “recent emergency events in Washington, DC, resulting in the unforeseeable and understandable disruption of regular mail delivery and of the processing of other deliveries due to the threat of contamination,” i.e. , the discovery of anthrax contamination on Capitol Hill and at certain U.S. Postal Service mail processing facilities, and the consequent delay in mail processing due to quarantine and cleansing procedures associated with the anthrax contamination. The Commission stated, “[T]hese emergency procedures are adopted on a temporary basis only, and will be discontinued when normal U.S. Mail delivery resumes.”

We note that mail delivery in the Washington, DC area has improved, and that the United States Postal Service has greatly reduced the delay in processing mail. We also note that the Commission has expanded it electronic filing capabilities, and implemented its own processes to combat the threat of contamination of incoming mail. Given these circumstances, we conclude that the interim electronic filing procedures adopted by the Commission in 2001 are no longer necessary. Accordingly, we rescind those procedures, effective ninety days after publication of this Order in the Federal Register . (This includes elimination of interim facsimile number 202-418-0187 and the following Office of the Secretary Bureau and Office e-mail addresses: MMBSecretary@fcc.gov; WTBSecretary@fcc.gov; CCBSecretary@fcc.gov; CSBSecretary@fcc.gov; IBSecretary@fcc.gov; EBSecretary@fcc.gov; OtherSecretary@fcc.gov. ) Thereafter, filings will no longer be accepted by facsimile or e-mail, unless specifically authorized by the Commission's rules.

Pursuant to the authority of section 4(i) of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), the interim electronic filing procedures adopted in Order FCC 01-345, at 66 FR 62991, December 4, 2001, are rescinded.

This is a synopsis of the Commission's Memorandum Opinion and Order, adopted June 6, 2007, and released June 8, 2007. The full text of this decision is available for inspection and copying during normal business hours in the FCC Reference Information Center at Portals II, 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., 445 12th Street, SW., Room CY-B402, Washington, DC 20554, telephone 1-800-378-3160 or http://www.BCPIWEB.com. This document is not subject to the Congressional Review Act. (The Commission will not send a copy of this Memorandum Opinion and Order pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A), because there were no rule changes made herein.)

This is a summary of the Commission's Order in WP Docket No. 07-100, FCC 07-85, adopted on May 9, 2007, and released May 14, 2007. The full text of this document is available for inspection and copying during normal business hours in the FCC Reference Center, 445 12th Street, SW., Washington, DC 20554. The complete text may be purchased from the Commission's copy contractor, Best Copy and Printing, Inc., 445 12th Street, SW., Room CY-B402, Washington, DC 20554. The full text may also be downloaded at: http://www.fcc.gov. Alternative formats are available to persons with disabilities by sending an e-mail to fcc504@fcc.gov or by calling the Consumer & Governmental Affairs Bureau at 202-418-0530 (voice), 202-418-0432 (tty).

1. Part 90 contains the rules for both the Private Land Mobile Radio (PLMR) Services and certain Commercial Mobile Radio Services (CMRS). PLMR licensees generally do not provide for-profit communications services. Some examples of PLMR licensees are public safety agencies, businesses that use radio only for their internal operations, utilities, transportation entities, and medical service providers. CMRS licensees, by comparison, do provide for-profit communications services, such as paging and Specialized Mobile Radio services that offer customers communications that are interconnected to the public switched network.

2. We take this opportunity to make certain minor editorial amendments to part 90 to correct errors or omissions of publication, eliminate duplicative language, and conform language among rule sections.

3. This document does not contain proposed information collection(s) subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13. In addition, therefore, it does not contain any new or modified “information collection burden for small business concerns with fewer than 25 employees,” pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4).

This emergency closure is being implemented at the request of the FDA after samples of shellfish from the inshore and offshore waters off of the coasts of New Hampshire and Massachusetts tested positive for the toxins (saxotoxins) that cause PSP. These toxins are produced by the alga Alexandrium fundyense which can form blooms commonly referred to as red tides. Red tide blooms, also known as harmful algal blooms (HABs), can produce toxins that accumulate in filter-feeding shellfish. Shellfish contaminated with the toxin, if eaten in large enough quantity, can cause illness or death from PSP.

On June 10, 2005, the FDA requested that NMFS close an area of Federal waters off the coasts of New Hampshire and Massachusetts to fishing for bivalve shellfish intended for human consumption. On June 16, 2005, NMFS published an emergency rule (70 FR 35047) closing the area recommended by the FDA, i.e., the Temporary PSP Closure Area, through September 30, 2005. On July 7, 2005 (70 FR 39192), the emergency rule was modified to facilitate the testing of shellfish for the toxin that causes PSP by the FDA and/or FDA-approved laboratories through the issuance of a Letter of Authorization (LOA) from the NMFS Regional Administrator. On September 9, 2005 (70 FR 53580), the emergency regulation was once again modified by the division of the Temporary PSP Closure Area into northern and southern components. The northern area remained closed to the harvest of all bivalve molluscan shellfish while the southern component was reopened to the harvest of Atlantic surfclams and ocean quahogs but remained closed to the harvest of whole or roe-on scallops. The rule was extended as published on September 9, 2005, on October 3, 2005 (70 FR 57517), reinstated on October 18, 2005 (70 FR 60450) to correct a technical error, extended on December 28, 2005 (70 FR 76713), and subsequently on June 30, 2006 (71 FR 37505), and again on January 4, 2007 (72 FR 291) through June 30, 2007. On May 18, 2007, the FDA indicated that it could not support the re-opening of the Temporary PSP Closure Area due to insufficient analytical data from the area.

The boundaries of the northern component of the Temporary PSP Closure Area comprise Federal waters bound by the following coordinates in the order stated: (1) 43°00′ N. lat., 71°00′ W. long.; (2) 43° 00′ N. lat., 69° 00′ W. long.; (3) 41°39′ N. lat., 69° 00′ W. long.; (4) 41° 39′ N. lat., 71° 00′ W. long., and then ending at the first point. Under this emergency rule, this area would remain closed to the harvest of Atlantic surfclams, ocean quahogs, and whole or roe-on scallops. The boundaries of the southern component of the Temporary PSP Closure Area comprise Federal waters bound by the following coordinates in the order stated: (1) 41° 39′ N. lat., 71° 00′ W. long.; (2) 41° 39′ N. lat., 69° 00′ W. long.; (3) 40° 00′ N. lat., 69° 00′ W. long.; (4) 40° 00′ N. lat., 71° 00′ W. long., and then ending at the first point. Under this emergency rule, this southern component of the area would remain closed only to the harvest of whole or roe-on scallops.

This action is issued pursuant to section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), 16 U.S.C. 1855(c). Pursuant to section 5 U.S.C. 553(b)(B) of the Administrative Procedure Act, the Assistant Administrator for Fisheries finds there is good cause to waive prior notice and an opportunity for public comment on this action as notice and comment would be impracticable and contrary to the public interest due to a public health emergency, and public comment has been solicited concurrently with each of the extensions of this actions as detailed and responded to below. In addition, under section 553(d)(3) there is good cause to waive the 30-day delay in effectiveness due to a public health emergency. The original emergency closure was in response to a public health emergency. Toxic algal blooms are responsible for the marine toxin that causes PSP in persons consuming affected shellfish. People have become seriously ill and some have died from consuming affected shellfish under similar circumstances. Pursuant to section 305(c)(3)(C) of the Magnuson-Stevens Act, the closure to the harvest of shellfish, as modified on September 9, 2005, and re-instated on October 18, 2005, may remain in effect until the circumstances that created the emergency no longer exist, provided the public has had an opportunity to comment after the regulation was published, and, in the case of a public health emergency, the Secretary of Health and Human Services concurs with the Commerce Secretary's action. During the initial comment period, June 16, 2005, through August 1, 2005, no comments were received. One comment was received after the re-opening of the southern component of the Temporary PSP Closure Area on September 9, 2005. The commenter expressed reluctance to re-opening a portion of the closure area without seeing the results of the FDA tests. Data used to make determinations regarding closing and opening of areas to certain types of fishing activity are collected from Federal, state, and private laboratories. NOAA maintains a Red Tide Information Center ( http://www.cop.noaa.gov/news/fs/ne_hab_200605.html ), which can be accessed directly or through the website listed in the ADDRESSES section. Information on test results, modeling of algal bloom movement, and general background on red tide can be accessed through this information center. While NMFS is the agency with the authority to promulgate the emergency regulations, it modified the regulations on September 9, 2005, at the request of the FDA, after the FDA has determined that the results of its tests warranted such action. If necessary, the regulations may be terminated at an earlier date, pursuant to section 305(c)(3)(D) of the Magnuson-Stevens Act, by publication in the Federal Register of a notice of termination, or extended further to ensure the safety of human health.

This emergency/interim rule is exempt from the procedures of the Regulatory Flexibility Act because the rule is issued without opportunity for prior notice and opportunity for public comment.

The rule, as last published on October 18, 2005, was determined to be not significant for the purposes of Executive Order 12866.