In 1990, Congress passed the OFPA, which required the USDA to develop national standards for organically produced agricultural products to assure consumers that agricultural products marketed as organic meet consistent, uniform standards. Based on the requirements of the OFPA, USDA established the NOP to develop national organic standards, including a National List of substances approved for and prohibited from use in organic production and handling, that would require agricultural products labeled as organic to originate from farms or handling operations certified by a State or private entity that has been accredited by USDA. On December 21, 2000, USDA published the final rule for the NOP in the Federal Register (7 CFR part 205). On October 21, 2002, the NOP regulations became fully implemented by USDA as the uniform standard of production and handling for organic agricultural products in the United States.

In October 2003, Arthur Harvey filed a complaint under the Administrative Procedure Act in the U.S. District Court, District of Maine. Mr. Harvey alleged that several subsections of the NOP regulations violated OFPA, were arbitrary, and not in accordance with law.

On January 26, 2005, the U.S. Court of Appeals for the First Circuit issued a decision in the case. The court upheld the NOP regulations in general, but remanded the case to the U.S. District Court, District of Maine, for, among other things, the entry of a declaratory judgment that stated 7 CFR 205.606 does not establish a blanket exemption to the National List requirements specified in 7 U.S.C. 6517, permitting the use of nonorganic agricultural products in or on processed organic products when their organic form is not commercially available. The district court ordered the Secretary to make publicly known within 30 days—through notice in the Federal Register to all certifying agents and interested parties—that 7 CFR 205.606 shall be interpreted to permit only the use of a nonorganically produced agricultural product that has been listed in 7 CFR 205.606 pursuant to National List procedures, and when a certifying agent has determined that the organic form of the agricultural product is not commercially available. USDA complied with this order on July 1, 2005 (70 FR 38090).

The court also ruled in favor of Mr. Harvey with respect to 7 CFR 205.605(b) of the NOP regulations, concerning the use of synthetic substances in or on processed products which contain a minimum of 95 percent organic content and are eligible to bear the USDA seal (7 CFR 205.605(b)). The court found § 205.605(b) contrary to the OFPA and in excess of the Secretary's rulemaking authority.

In addition, the court found in favor of Harvey with respect to 7 CFR 205.236(a)(2)(i) of the NOP regulations. This section creates an exception to the general requirements for the conversion of whole dairy herds to organic production. The court found the provisions at 7 CFR 205.236(a)(2)(i) contrary to the OFPA and in excess of the Secretary's rulemaking authority.

On June 9, 2005, the district court issued its final judgment and order in the case. A copy of the final judgment and order may be found at https://www.ams.usda.gov/nop .

After the court issued its final judgment and order, Congress amended the OFPA. On November 10, 2005, Congress amended the OFPA by permitting the addition of synthetic substances appearing on the National List for use in products labeled “organic.” The amendment restores the NOP regulation for organic processed products containing at least 95 percent organic ingredients on the National List and their ability to carry the USDA seal. Therefore, USDA is not revising the NOP regulations to prohibit the use of synthetic ingredients in processed products labeled as organic nor restrict these products' eligibility to carry the USDA seal.

Congress also amended the OFPA to allow a special provision for transitioning dairy livestock to organic production. The NOP regulations currently provided that when an entire, distinct herd is converted to organic production, the producer may, for the first 9 months of the year, provide a minimum of 80-percent feed that is either organic or raised from land included in the organic system plan and managed in compliance with organic crop requirements. The circuit court found these provisions to be contrary to the OFPA and in excess of the Secretary's rulemaking authority.

In the amendments to OFPA, Congress provided a new provision to allow crops and forage from land included in the organic system plan of a farm that is in the third year of organic management to be consumed by the dairy animals of the farm during the 12-month period immediately prior to the sale of organic milk and milk products. USDA is revising § 205.236(a)(2) to reflect this amendment to the OFPA in this rulemaking.

We received 13,115 comments, most as form letters (13,020). Comments were received from consumers, producers, processors, trade associations, food industry organizations, certifying agents, the National Organic Standards Board (NOSB), and state governments. The majority of the comments received dealt with the proposed changes to the dairy animal language in the regulation.

Several comments requested a more lengthy comment period than the 15-day comment period provided. However, the Department determined that the changes that were mandated by the U.S. District Court to be completed by June 4, 2006, had been well publicized for over a year, as the circuit court's decision was published on January 26, 2005. To meet the mandated court deadline therefore, a shortened comment period was considered appropriate.

Comments were received dealing with paragraph § 205.606 and how commercial availability and the National List procedures applies to products labeled as “made with organic (ingredients).” This was an error in the proposed rule; paragraph § 205.606 should only pertain to products labeled as “organic.” Because products labeled as “made with organic (ingredients)” may, by definition, contain up to 30 percent nonorganic agricultural ingredients, regardless of commercial availability, we have corrected the language in this final rule.

Commenters requested that changes be made to § 205.600(b), dealing with the criteria by which materials are evaluated by the National Organic Standards Board (NOSB) for inclusion on the National List. Specifically, commenters asked to eliminate the words “processing aids and adjuvants” in the criteria of synthetics to be reviewed of handling materials under § 205.600(b). The Department has no position on this comment at this time, as the comments go beyond the scope of the proposed rule. These comments will be provided to the NOSB and the NOSB may consider whether to make a recommendation to the Department for amending the NOP regulations.

Other commenters discussed the definitions of the terms “ingredient,” “processing aid,” and “substance.” These commenters suggested that changes in the NOP regulations section of definitions, or elimination of some words altogether elsewhere in the NOP regulations, could improve the clarity of the NOP regulations with respect to how materials are evaluated for inclusion on the National List.

In response to the commenters' suggestions to improve the clarity of the NOP regulations by revising aforementioned terms, the Department welcomes these suggestions. However, these comments will be provided to the NOSB for consideration of a recommendation to the Department for amending the NOP regulations through future notice and comment rulemaking. As noted above, this rulemaking seeks merely to satisfy the court final order and judgment and implement the Congressional amendments at this time.

We also received several comments related to the amendment to the OFPA by Congress that authorized the Secretary to establish procedures for adding nonorganic agricultural materials to the National List in the event of an emergency if they are commercially unavailable in organic form. These commenters asked for a 60-day notice and comment rulemaking period; commenters also asked when and how the Department planned to proceed with such rulemaking. Since this amendment to the OFPA is not part of this rulemaking, the Department will proceed through normal notice and comment rulemaking procedures and consult with the NOSB prior to publishing a proposed rule on emergency petition procedures.

The vast majority of the comments received dealt with subparagraph § 205.236(a)(i). Most comments were positive for keeping the last third of gestation for conversion of an entire dairy herd in the regulation. However, these commenters wanted the last third of gestation clause to apply to all dairy operations once the operation is certified as organic, regardless of the number of animals converted, or whether an entire, distinct herd is converted.

When Congress amended the OFPA, only the feed provision was addressed, to provide a different method of transition for dairy animals entering organic production. This final rule implements the Congressional amendments and the court's final judgment. USDA recognizes that this change still leaves two methods of replacement of dairy animals for organic dairy operations and that this is a matter of concern in the organic community. To address the issue of dairy replacement animals for all certified organic dairy operations, USDA will draft an advanced notice of proposed rulemaking (ANPR) to invite public comment on further changes necessary to the NOP regulations dealing with the origin of dairy livestock under subparagraph § 205.236(a)(2), Dairy Animals.

We received comments that expressed concern that producers would be able to feed dairy animals feed and forage that had been harvested earlier than the third year, from land in transition to organic and that a certifying agent must be able to inspect the records to verify that this does not occur. This is a valid concern, and commas have been inserted in the final regulation to make clear that crops and forage must come from land that is in the third year of transition to organic.

Documents related to this final rule include the OFPA, as amended, (7 U.S.C. 6501 et seq. ), its implementing regulations (7 CFR part 205), and a Federal Register notice publishing the final judgment and order in the case of Harvey v. Johanns (70 FR 38090).

This action has been determined not significant for purposes of Executive Order 12866, and therefore, does not have to be 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 final rule is not intended to have a retroactive effect.

States and local jurisdictions are preempted under section 2115 of the OFPA (7 U.S.C. 6514) 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 Sec. 2115(b) of the OFPA (7 U.S.C. 6514(b)). States are also preempted under Sec. 2104 through 2108 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 section 2108(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 section 2120(f) of the OFPA (7 U.S.C. 6519(f)), this 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 2121 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). AMS has also considered the economic impact of this action on small entities and has determined that this final rule would have an impact on a substantial number of small entities.

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.

The U.S. organic industry at the end of 2001 included nearly 6,949 certified organic crop and livestock operations. These operations reported certified acreage totaling just over 2 million acres of organic farm production. Data on the numbers of certified organic handling operations (any operation that transforms raw product into processed products using organic ingredients) were not available at the time of survey in 2001; but they were estimated to be in the thousands. Based on 2003 data, certified organic acreage had increased to 2.2 million acres. By the end of 2004, the number of certified organic crop, livestock, and handling operations totaled nearly 11,400 operations, based on reports by certifying agents to NOP as part of their annual reporting requirements. AMS believes that most of these entities would be considered small entities under the criteria established by the SBA.

U.S. sales of organic food and beverages have grown from $1 billion in 1990 to an estimated $12.2 billion in 2004. Organic food sales are projected to reach nearly $15 billion for 2005. The organic industry is viewed as the fastest growing sector of agriculture, representing 2 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. This growth rate is projected to decline and fall to a rate of 5 to 10 percent in the future.

In addition, USDA has accredited 96 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 AMS 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.

The loss of the 80-20 feed exception can be measured depending on various feed costs, for average farm sizes, and for the sector as a whole using 2003 estimates of the number of certified dairy livestock in the United States—the latest year for which numbers are available. 1 Generally, for organic dairy operations, feed and labor are the most significant cost components, comprising upwards of 50 percent of the total variable costs of the operation. 2 Organic feed is significantly more expensive than conventional feed, and various quotes for organic feed run as high as double the cost of conventional or nonorganic feed rations. According to one study, higher feed cost was the largest and most important difference between organic and nonorganic dairy production, with the additional expense of feeding organic dairy costs being 54 percent of the price differential received for organic milk. 3 In this study, for a 48-cow organic herd, purchased feed cost $1,003 per cow, or $298 per cow more than for a conventional dairy operation. For the entire year, the average farm spent approximately $49,000 for purchased organic feed for the 48-cow herd in this study.

A rough estimate of the loss of the 80-20 feed exception can be determined using this study's farm cost numbers. Using the estimated per-cow feed numbers, if a dairy farmer had to switch from using 80 percent organic feed to 100 percent organic feed, and purchased all of the organic feed, the additional cost to the dairy farmer is $27 per month, or about 2.7 percent higher than using the 80-20 feed exception.

For the sector, based on ERS's latest estimate of approximately 74,435 certified dairy cows in 2003, the loss of the 80-20 feed provision using the above cost estimates would amount to around $2 million. But this assumes: (1) All of the dairy cows in the sector are converted to organic in the same year; (2) all farm operators use the 80-20 feed provision in that same year; and (3) all organic feed was purchased. Because these assumptions are unlikely, the $2 million estimated for the sector likely overstates the total cost of the loss of the 80-20 feed provision. This cost estimate more likely represents an upper bound estimate based on this farm study's feed cost estimate, as if all dairy cows were converted to organic at a single point in time under the above assumptions.

Instead, an alternative estimate could be derived for a growing industry that is adding new dairy cows to the industry. According to ERS, in 2000, there were just over 38,000 certified dairy livestock, increasing to nearly 49,000 by 2001, and 67,000 in 2002. With reports of rising milk prices and shortages in the U.S. organic dairy market in 2005, continued growth in organic dairy livestock numbers could be expected.

Therefore, an alternative estimate of the loss is to calculate the number of dairy cows added to the sector each year and assume they were all added to the sector by being converted using the 80-20 feed transition provision. Using the ERS numbers above, between 2000 and 2001, 11,000 certified dairy cows were added. Another 18,000 cows were added by 2002, and 7,435 in 2003. On average, 12,145 dairy cows were added each year since 2000. Based on these numbers from ERS and the additional cost of $27 per cow from the study above, using the 80-20 feed provision, the loss of the 80-20 provision would have cost dairy farmers approximately $327,915 per year, or nearly $1 million over the 3-year period.

Different estimates were obtained from discussions with Western state industry experts in dairy feed and nutrition, and budgets developed by certifying agents who work with certified dairy operations. 4 These estimates resulted in higher costs due to the loss of the 80-20 feed provision, of as much as $416 per cow annually, or assuming an addition of approximately 12,000 cows per year to the sector, a loss of nearly $5 million per year to the sector.

Depending on location, climate, size, and purchased feed, costs may vary considerably. The west, for example, tends to be a feed-deficit region where farmers purchase more feed and rely less on feed from on-farm or nearby sources. The farther the distance a farmer has to go to obtain feed, the more costly the feed will be, all other things being equal, making it likely that costs would vary by region or climate.

With higher milk prices, more farmers might be attracted to enter organic dairy farming. In the short run, this would add to pressure (due to more competition) on feed supplies. With the loss of the 80-20 feed provision, this could drive up the cost of feed; in the short run, therefore, there could be additional upward pressure on these cost estimates.

Regardless, these additional costs would have to be absorbed somewhere. They must either be passed forward to consumers in the form of higher fluid milk and dairy product prices—already at high premiums relative to conventional dairy product prices—or they would have to be absorbed by farmers.

However, Congress did amend OFPA for transitioning dairy farmers, by permitting such dairy farmers to graze dairy livestock on land being converted to organic production during its 3rd year of transition. Thus, the loss of the 80-20 feed exception is mitigated in part by the action that Congress took. In effect, a farm transitioning its dairy cows to organic could put its cows on that farm's pasture being converted to organic and the milk from those cows would be organic at the same time as crops being harvested from that land—at the end of the third year that the land completed organic management.

Congress leveled the playing field for dairy farmers when they amended OFPA in this area by removing any penalties that dairy farmers faced with the so-called “4th year”— i.e. , the additional transition year that dairy cows underwent due to lactation cycles. And Congress did not change the basic requirement of OFPA. Dairy cows must be organically managed for at least 12 months; after these 12 months of organic management, only her milk and milk products may be represented as organic.

The status of the dairy cow is a different story. The dairy cow is only organic if she was raised organically from the last third of the mother's gestation. When a dairy cow is slaughtered, she cannot be sold as organic slaughter stock unless she was raised organically from the last third of the mother's gestation, the same as other slaughter livestock (except poultry, which must be raised organically beginning with the second day of life). That remains the same in the NOP regulation.

In providing the transition language, entry in organic dairying may become easier, which could ease current milk shortages in the organic milk market at retail. Certainly it should help smaller dairy farmers entering the organic industry who may be faced with having to purchase higher priced organic feed, by allowing them to graze dairy livestock on their land that is being transitioned to organic certification.

Other changes in this rule merely implement Congressional amendments and the court's final judgment and order. With respect to alternatives to this rule, as stated above, this rule merely implements language which Congress has enacted and complies with the court's final judgment and order.

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.

USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this rule.

No additional collection or recordkeeping requirements are imposed on the public by this rule. Accordingly, OMB clearance is not required by § 305(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.

Further, given the Congressional amendments, and the court's final judgment and order, good cause exists under 5 U.S.C. 533 for not postponing the effective date of this rule, except § 205.606, until 30 days after publication in the Federal Register .

On February 9, 2006, we issued AD 2006-04-11, amendment 39-14492 (71 FR 8792, February 21, 2006), for certain Airbus Model A321-111, -112, and -131 airplanes. That AD requires repetitive inspections to detect fatigue cracking in the area surrounding certain attachment holes of the forward pintle fittings of the main landing gear (MLG) and the actuating cylinder anchorage fittings on the inner rear spar; and repair, if necessary. That AD also provides for optional terminating action for the repetitive inspections, adds inspections of three additional mounting holes, and revises the thresholds for the currently required inspections. That AD resulted from manufacturer analysis of the fatigue and damage tolerance of the area surrounding certain mounting holes of the MLG. We issued that AD to detect and correct fatigue cracking on the inner rear spar of the wings, which could result in reduced structural integrity of the airplane.

Since we issued AD 2006-04-11, amendment 39-14492, a typographical error was discovered in the applicability of that AD, which could cause the unsafe condition on an affected airplane to remained uncorrected. The applicability of that AD states, “all manufacturer serial numbers (MSN), except MSN 364 and 365.” The correct reference should have been, “all manufacturer serial numbers (MSN), except MSN 364 and 385.”

Airbus Service Bulletin A320-57-1101, Revision 03, dated July 30, 2003, which also describes procedures for reporting inspection findings to Airbus, was inadvertently omitted from paragraph (m) of AD 2006-04-11, which specifies that we do not require reports of inspection findings. We have revised paragraph (m) of this AD to include Service Bulletin A320-57-1101, Revision 3.

This airplane model is manufactured in France and is type certificated for operation in the United States under the provisions of section 21.29 of the Federal Aviation Regulations (14 CFR 21.29) and the applicable bilateral airworthiness agreement. Pursuant to this bilateral airworthiness agreement, the DGAC has kept the FAA informed of the situation described above. We have examined the DGAC's findings, evaluated all pertinent information, and determined that we need to issue an AD for products of this type design that are certificated for operation in the United States.

This new AD revises the applicability of AD 2006-04-11 by correcting the reference, “all manufacturer serial numbers (MSN), except MSN 364 and 365,” to read “all manufacturer serial numbers (MSN), except MSN 364 and 385.” This new AD also retains the requirements of AD 2006-04-11.

The revisions made to this AD add no additional economic burden. The current costs for this AD are repeated for the convenience of affected operators, as follows:

None of the airplanes affected by this action are on the U.S. Register. All airplanes included in the applicability of this AD currently are operated by non-U.S. operators under foreign registry; therefore, they are not directly affected by this AD action. However, we consider that this AD is necessary to ensure that the unsafe condition is addressed in the event that any of these subject airplanes are imported and placed on the U.S. Register in the future.

If an affected airplane is imported and placed on the U.S. Register in the future, it would require approximately 22 work hours to accomplish the required actions at an average labor rate of $65 per work hour. Based on these figures, the cost impact of this AD would be $1,430 per airplane.

If an operator elects to accomplish the optional terminating action provided by this AD, it would take approximately 520 work hours to accomplish, at an average labor rate of $65 per work hour. The cost of required parts would be approximately $17,540 per airplane. Based on these figures, the cost impact of the optional terminating action would be $51,340 per airplane.

No airplane affected by this AD is currently on the U.S. Register. Therefore, providing notice and opportunity for public comment is unnecessary before this AD is issued, and this AD may be made effective in less than 30 days after it is published in the Federal Register .

This AD is a final rule that involves requirements that affect flight safety and was not preceded by notice and an opportunity for public comment; however, we invite you to submit any relevant written data, views, or arguments regarding this AD. Send your comments to the address listed under the ADDRESSES section. Include “Docket No. FAA-2006-24953; Directorate Identifier 2006-NM-084-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of the AD that might suggest a need to modify it.

We will post all comments we receive, without change, to http://dms.dot.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact with FAA personnel concerning this AD. Using the search function of that Web site, anyone can find and read the comments in any of our dockets, including the name of the individual who sent the comment (or signed the comment on behalf of an association, business, labor union, etc.). You may review the DOT's complete Privacy Act Statement in the Federal Register published on April 11, 2000 (65 FR 19477-78), or you may visit http://dms.dot.gov.

You may examine the AD docket on the Internet at http://dms.dot.gov, or in person at the Docket Management Facility office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket Management Facility office (telephone (800) 647-5227) is located on the plaza level of the Nassif Building at the DOT street address stated in the ADDRESSES section. Comments will be available in the AD docket shortly after the Docket Management System receives them.

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

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

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

For the reasons discussed above, I certify that the regulation:

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

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

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

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket. See the ADDRESSES section for a location to examine the regulatory evaluation.

You may examine the airworthiness directive (AD) docket on the Internet at http://dms.dot.gov or in person at the Docket Management Facility office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket Management Facility office (telephone (800) 647-5227) is located on the plaza level of the Nassif Building at the street address stated in the ADDRESSES section.

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to certain Boeing transport category airplanes. That NPRM was published in the Federal Register on October 7, 2005 (70 FR 58628). That NPRM proposed to require inspecting to determine if certain galleys and closets are installed, and replacing the spiral wire wrapping of the electrical cables of the galleys and closets with new spiral wire wrapping if necessary.

We provided the public the opportunity to participate in the development of this AD. We have considered the comments received.

Four commenters, Northwest Airlines, Boeing, AirTran, and the Air Transport Association agree with the intent and contents of the NPRM.

Several commenters state that there are various problems interpreting the applicability of the NPRM. One commenter, Air Nippon, states that the effectivity in Boeing Special Attention Service Bulletin 737-25-1438, Revision 1, dated November 11, 2004, includes certain airplanes that are equipped with Showa galleys. However, the commenter further states that the galleys installed for these airplanes are not those referenced in Showa Aircraft Industry Service Bulletin 25-30-111, dated December 11, 2000, specifically part numbers 60216-1, 60217-1, and 60218-1. The commenter further points out that it has airplanes that have Showa galleys installed, but that those airplanes are not referenced in the Boeing service bulletin. The commenter states that it cannot proceed with the proposed actions because there is no Showa service bulletin issued for the Air Nippon airplanes. Air Nippon requests that we coordinate between both service bulletins to verify that there is consistency between the affected airplanes and the galleys installed on those airplanes. Air Nippon further states that a well-coordinated position is needed in order for it to comply with the AD.

Another commenter, Delta Airlines, states that it understands it must take action on all of its Boeing Model 767-300 airplanes (not just those listed in the Model 767's service bulletin). However, Delta states that with respect to the other service bulletins referenced in the NPRM (e.g., regarding Models 737-300, 737-800, and 757 airplanes), there are no Delta airplanes listed. The commenter states that it could be interpreted to mean that we do not need to review those other fleet types.

Yet another commenter, Alaska Airlines, points out that, although Driessen Aircraft Interior Systems Service Bulletin 25-442, Revision E, dated April 29, 2004, specifies the effectivity as “All galleys manufactured before May 2000,” the NPRM does not mention any difference between galleys manufactured before or after May 2000. The commenter states that it is not clear whether the AD applies to “any” galley having the part number specified in the Driessen service bulletin, or only to galleys manufactured before May 2000 that have the part number specified.

We do not agree that revision of the applicability of this AD is necessary. This AD does not specify the applicability of airplanes as identified in the effectivity section of any service bulletin specified in the NPRM. Since the AD identifies the airplane models it applies to in paragraph (c)(1) through (c)(5) inclusive of this AD, it means all of those airplanes that are equipped with certain Driessen Aircraft Interior Systems or Showa Aircraft Industry galleys. Identifying the applicability in this way precludes the necessity of revising the Boeing or vendor service bulletins (Showa or Driessen) to ensure that all airplanes are inspected. The actions required by this AD are not limited to the airplanes specified in certain Boeing service bulletins or to certain galleys manufactured before May 2000. After a specific line number within the Boeing production system, unacceptable spiral wire wrapping was removed and replaced with acceptable spiral wire wrapping. However, galleys can be removed and replaced with galleys other than the galleys installed at delivery of the airplane. Consequently, it is not possible to correlate the corrective action to specific airplane line numbers. Additionally, paragraph (g) of the AD clearly states that, if no galley is installed having any P/N identified in the service information specified in paragraph (f) of the AD, no further action is required.

Two commenters, AirTran Airways and Northwest Airlines, note that certain costs specified in the Boeing service bulletins are not included in the NPRM. AirTran Airways specifies that labor costs for removal and replacement of the galley should be considered in the estimated cost of compliance. Northwest Airlines notes that one service bulletin's estimated work hours is 116 labor hours more than the NPRM's estimated work hours. Additionally, Northwest Airlines states that the estimate of two hours per galley seems to be low, and suggests that a better estimate to accomplish the work would be four hours per galley.

We do not agree that the “Costs of Compliance” section should be revised. The cost impact figures discussed in AD rulemaking actions represent only the time necessary to perform the specific actions actually required by the AD. We recognize that, in doing the actions required by an AD, operators may incur incidental costs in addition to the direct costs. The cost analysis in AD rulemaking actions, however, typically does not include incidental costs such as the time required to gain access and close up, time necessary for planning, or time necessitated by other administrative actions. Those incidental costs, which may vary significantly among operators, are almost impossible to calculate. Also, Northwest Airlines did not provide any justification as to why we should revise the number of hours estimated to remove and replace the spiral wrap from two to four. Therefore, we have determined that the estimate of two work hours based on the service bulletin is adequate. No change is necessary to the AD in this regard.

One commenter, American Airlines, states that its fleet has less than 30 square inches of spiral wrap per airplane. Because of the small amount of material on these airplanes, American Airlines suggests that a maximum amount of material installed, such as 144 square inches, be set as the threshold for any required action. The commenter requests that no action be required for any airplanes with less spiral wrap installed than the threshold.

We do not agree with the commenter. The commenter provides no technical justification to support its suggestion that less than 144 square inches of material mitigates the unsafe condition. The amount of material the commenter suggests as an acceptable limit could potentially measure 16 linear feet, and that amount of material still has the ability to propagate a fire within the hidden area of the airplane. Therefore, we have determined that it is unnecessary to revise the AD in this regard. Under the provisions of paragraph (j)(1) of the final rule, we may approve requests for an alternative method of compliance if data are submitted to substantiate that such an adjustment would provide an acceptable level of safety.

One commenter, Northwest Airlines, states that the effectivity for certain airplanes specified in the Driessen Aircraft Interior Systems service bulletin is in error. The commenter also explains that the company is aware of the error in the service bulletin and is in the process of correcting the associated descriptions for each galley part number. The commenter requests that we reference the new corrected service bulletin in the AD.

We do not agree with the commenter. During discussions with Driessen Aircraft Interior Systems, we were advised that there are no plans for updating the descriptions for these galleys. However, we do not consider that revision of the Driessen service bulletin is necessary in this case in order for operators to comply with the AD. Since the part numbers defined with the service bulletin are correct, it is only the description of the galley that could be expanded. In consideration of the flammability of the existing spiral wrap, we have determined that it would be inappropriate to delay issuance of this AD until a new service bulletin has been developed and approved. However, once the service bulletin is approved and available, the commenter may request approval of an AMOC in accordance with paragraph (j)(1) of this AD. No change to the AD is necessary in this regard.

One commenter, AirTran Airways, requests that we specify the affected part numbers in the NPRM. Although AirTran states that the NPRM does not affect any of its airplanes, it suggests that specifying part numbers could benefit operators.

In this case, we do not agree to specify the part numbers in the AD, since the affected part numbers are clearly specified in the referenced service information. Not only would it appear to be redundant to repeat the part numbers in the AD, but when there are large numbers of parts involved, it could increase the risk of error in repeating those part numbers in the AD.

One commenter, Delta Airlines, requests that the FAA clarify or expand the statement “maintenance record check of the airplane.” Delta suggests that, rather than a search through maintenance records, a review of installation drawings, internal Engineering Authorizations, the Illustrated Parts Catalog, and other such documents would also provide a clear picture of which galleys/closets are installed.

We do not agree with the commenter that it is necessary to expand the definition of “airplane maintenance records.” The NPRM uses the phrase “airplane maintenance records,” because that is consistent with the wording of section 121.380 (“Maintenance Recording Requirements”) of the Federal Aviation Regulations (14 CFR 121.380). That regulation defines the maintenance recording requirements for certificate holders. The term, as specified in the NPRM, is not meant to imply that determination of the installed component used must be determined from the airplane-level document, but rather the explanation as specified in section 121.380 of the Federal Aviation Regulations (14 CFR 121.380). Examples of other such supporting documents include maintenance program documentation and maintenance task cards. Therefore, we find that it is unnecessary to revise the AD in this regard.

We have revised this AD to clarify the appropriate procedure for notifying the principal inspector before using any approved AMOC on any airplane to which the AMOC applies.

We have carefully reviewed the available data, including the comments received, and determined that air safety and the public interest require adopting the AD with the single clarification described previously. We have determined that this clarification will neither increase the economic burden on any operator nor increase the scope of the AD.

There are about 5,177 airplanes of the affected design in the worldwide fleet. This AD will affect about 2,621 airplanes of U.S. registry. The inspection to determine part numbers of the galleys will take about 1 work hour per galley, at an average labor rate of $65 per work hour. Some airplanes have only one galley and some have up to 11 galleys. With the exception of Boeing Model 777-300 airplanes, we estimate the cost of the inspection in this AD for U.S. operators to be between $65 and $715 per airplane.

If an operator is required to replace the spiral protective wrapping of the electrical cables of the galley, we estimate that cost will be as follows:

1. For Driessen galleys: About two work hours per galley, at an average labor rate of $65 per work hour, and the cost for the new spiral protective wrapping to be about $1,450, per galley. The estimated total cost will be about $1,580, per galley.

2. For Showa galleys: About 20 work hours per galley, at an average labor rate of $65 per work hour, and the cost of the new spiral protective wrapping to be about $1,550, per galley. The estimated total cost will be about $2,850, per galley.

Currently, there are no Boeing Model 777-300 airplanes with the subject galleys on the U.S. Register. However, if a Model 777-300 is imported and placed on the U.S. Register in the future, the required actions will take about 1 work hour per galley, at an average labor rate of $65 per work hour.

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

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

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

For the reasons discussed above, I certify that this AD:

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

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

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

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket. See the ADDRESSES section for a location to examine the regulatory evaluation.

You may examine the airworthiness directive (AD) docket on the Internet at http://dms.dot.gov or in person at the Docket Management Facility office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket Management Facility office (telephone (800) 647-5227) is located on the plaza level of the Nassif Building at the street address stated in the ADDRESSES section.

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that supersedes AD 2004-08-03, amendment 39-13572 (69 FR 19756, April 14, 2004). The existing AD applies to certain Airbus Model A300 B4-600 and A300 C4-600 series airplanes. That NPRM was published in the Federal Register on March 27, 2006 (71 FR 15079). That NPRM proposed to require a one-time inspection to detect damage of the pump diffuser guide slots (bayonet) of the center tank fuel pumps, the pump diffuser housings, and the pump canisters; repetitive inspections to detect damage of the fuel pumps and the fuel pump canisters; and corrective action, if necessary. That NPRM proposed to add, for new airplanes, repetitive inspections of the pump bodies for cracking, damage, and missing and broken fasteners; repetitive inspections of the fuel pump canisters for a cracked flange web; and corrective actions if necessary. For all airplanes, that NPRM also proposed to add replacement of the fuel pump canisters with new reinforced fuel pump canisters, which ends the repetitive inspections.

We provided the public the opportunity to participate in the development of this AD. No comments have been received on the NPRM or on the determination of the cost to the public.

We have carefully reviewed the available data and determined that air safety and the public interest require adopting the AD as proposed.

This AD will affect about 74 airplanes of U.S. registry. The following table provides the estimated costs, at an average labor rate of $80 per hour, for U.S. operators to comply with this AD.

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

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

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

For the reasons discussed above, I certify that this AD:

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

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

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

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket. See the ADDRESSES section for a location to examine the regulatory evaluation.

We have received reports indicating that the midpivot bolt and midpivot bolt access door of the spring beam of the inboard side of the outboard struts were installed in the incorrect position on two airplanes. On one of the airplanes, the midpivot bolts and midpivot bolt access doors had been installed during accomplishment of the modification of the nacelle strut and wing structure in accordance with Boeing Service Bulletin 747-54A2157 (required by AD 95-13-05, amendment 39-9285 (60 FR 33333, June 28, 1995)). Investigation revealed that the service bulletin specified incorrect part numbers for the midpivot bolt access doors. In addition, the production installation drawings did not provide clear instructions for installing the midpivot bolts and midpivot bolt access doors, which resulted in the discrepancies on the other airplane.

The midpivot bolt access door is attached to the skin of the inboard side of the outboard struts. A midpivot bolt access door has anti-rotation tabs that fit the slots of the midpivot bolt's head. If any midpivot bolt access door is not installed correctly or if its anti-rotation tabs are not properly aligned with the slots of the midpivot bolt's head, the midpivot bolt and its internal lubrication channel will not be in correct position. When the lubrication channel is not in the correct position, a midpivot bolt could be overloaded and crack or fracture. These conditions, if not corrected, could result in the loss of a spring beam load path and consequent separation of the associated outboard strut and engine from the airplane.

We have reviewed Boeing Alert Service Bulletin 747-54A2225, dated February 16, 2006. The service bulletin describes the inspection procedures specified in the table below. The service bulletin also describes procedures for installing a placard on the midpivot bolt access doors, and doing applicable corrective actions if necessary. The applicable corrective actions include changing or replacing any midpivot bolt access door that is damaged or installed in the incorrect position with a new or serviceable midpivot bolt access door, and under certain conditions, replacing the midpivot bolt with a new bolt. The service bulletin specifies the following compliance time depending on the airplane configuration and accumulated flight cycles:

• “Within 24 months from the release date on this service bulletin or within 90 days from accumulating 8,000 flight cycles from the accomplishment of SB 747-54A2157, whichever occurs first;”

• “Within 24 months from the release on this service bulletin or within 90 days from accumulating 8,000 total flight cycles, whichever occurs first;” or

• “Within 90 days from the release date on this service bulletin.”

The unsafe condition described previously is likely to exist or develop on other airplanes of the same type design that may be registered in the U.S. at some time in the future. Therefore, we are issuing this AD to ensure that the subject midpivot bolts and midpivot bolt access doors are installed in the correct position. If not installed in the correct position, a midpivot bolt could be overloaded and crack or fracture, which could result in the loss of the spring load path and consequent separation of the associated outboard strut and engine from the airplane. This AD requires accomplishing the actions specified in the service information described previously, except as described under “Difference Between the Proposed AD and Service Bulletin.”

Operators should note that, although the Accomplishment Instructions of the referenced service bulletin describe procedures for submitting a report of inspection findings to Boeing, this AD will not require that action.

None of the airplanes affected by this action are on the U.S. Register. All airplanes affected by this AD are currently operated by non-U.S. operators under foreign registry; therefore, they are not directly affected by this AD action. However, we consider this AD necessary to ensure that the unsafe condition is addressed if any affected airplane is imported and placed on the U.S. Register in the future.

If an affected airplane is imported and placed on the U.S. Register in the future, the required inspection and installation of a placard would take about 6 work hours per airplane, at an average labor rate of $80 per work hour. Based on these figures, the estimated cost of the AD would be $480 per airplane.

No airplane affected by this AD is currently on the U.S. Register. Therefore, providing notice and opportunity for public comment is unnecessary before this AD is issued, and this AD may be made effective in less than 30 days after it is published in the Federal Register .

This AD is a final rule that involves requirements that affect flight safety and was not preceded by notice and an opportunity for public comment; however, we invite you to submit any relevant written data, views, or arguments regarding this AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2006-24950; Directorate Identifier 2006-NM-036-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of the AD that might suggest a need to modify it.

We will post all comments we receive, without change, to http://dms.dot.gov , including any personal information you provide. We will also post a report summarizing each substantive verbal contact with FAA personnel concerning this AD. Using the search function of that Web site, anyone can find and read the comments in any of our dockets, including the name of the individual who sent the comment (or signed the comment on behalf of an association, business, labor union, etc.). You may review the DOT's complete Privacy Act Statement in the Federal Register published on April 11, 2000 (65 FR 19477-78), or you may visit http://dms.dot.gov.

You may examine the AD docket on the Internet at http://dms.dot.gov , or in person at the Docket Management Facility office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket Management Facility office (telephone (800) 647-5227) is located on the plaza level of the Nassif Building at the DOT street address stated in the ADDRESSES section. Comments will be available in the AD docket shortly after the Docket Management System receives them.

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

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

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

For the reasons discussed above, I certify that the regulation:

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

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

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

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket. See the ADDRESSES section for a location to examine the regulatory evaluation.

History

An internal evaluation determined that the legal description for the Class D airspace at Pompano Beach, FL and Fort Lauderdale Executive Airport, FL contains reference to a line made up of radials off the Pompano Beach VOR, which has been decommissioned. This action will amend the legal description by replacing the reference to a line made up of a VOR radial, with a line now made up of geographic coordinates. Designations for Class D airspace areas extending upward from the surface of the earth are published in Paragraphs 5000 of FAA Order 7400.9N, dated September 1, 2005, and effective September 16, 2005, which is incorporated by reference in 14 CFR part 71.1. The Class D designations listed in this document will be published subsequently in the Order.

Since this action has no impact on the users of the airspace in the vicinity of the Pompano Beach Airpark or Fort Lauderdale Executive Airport, notice and public procedure under 5 U.S.C. 553(b) are not necessary.

This amendment to part 71 of the Federal Aviation Regulations (14 CFR part 71) amends Class D airspace at Pompano Beach, FL and Fort Lauderdale Executive Airport, FL.

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

History

On January 17, 2003, the Roosevelt Roads Naval Station, Ofstie Field, PR, was permanently closed and airport operations terminated. The closure, therefore, requires the removal of Class D and E5 airspace. Since the Isla de Vieques, PR, Class E5 airspace is included as part of the Roosevelt Roads, PR Class E5 airspace, the Isla de Vieques, PR, Class E5 airspace requires an amendment. This rule becomes effective on the date specified in the “Effective Date” section. Since this action eliminates the impact of controlled airspace on users of airspace in the vicinity of Roosevelt Roads, PR, notice and public procedure under 5 U.S.C. 553(b) are not necessary. Designations for Class D airspace and Class E airspace areas extending upward from 700 feet or more above the surface of the earth are published in paragraphs 5000 and 6005 respectively of FAA Order 7400.9N, dated September 1, 2005, and effective September 16, 2005, which is incorporated by reference in 14 CFR 71.1. The Class D and Class E airspace designations listed in this document will be published subsequently in the Order.

This amendment to part 71 of the Federal Aviation Regulations (14 CFR part 71) removes Class D and Class E5 airspace at Roosevelt Roads, PR, and amends Class E5 airspace at Isla de Vieques, PR.

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. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

During a review of the Class E5 700 foot airspace at Vandenberg AFB, CA, it was determined that additional controlled airspace was needed for Category E aircraft conducting circling maneuvers in conjunction with published Standard Instrument Procedures. Class E5 airspace areas are primarily designated to provide additional controlled airspace ancillary to a surface area to protect instrument operations for the primary airport, without imposing additional communications burdens on airspace users. This action is necessary at Vandenberg AFB to provide controlled airspace for Category E aircraft conducting circling maneuvers in conjunction with published Standard Instrument Procedures. Generally, Category E aircraft are very large and/or high performance. These aircraft require additional airspace when conducting circling maneuvers.

On March 24, 2006, the FAA published in the Federal Register a notice of proposed rulemaking to revise Class E airspace at Vandenberg AFB, CA (71 FR 14830). Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal. No comments were received, therefore, this revision is the same as that proposed in the notice.

Class E5 airspace areas are published in Paragraph 6005 of FAA Order 7400.9N, dated September 1, 2005, and effective September 15, 2005, which is incorporated by reference in 14 CFR 71.1. The Class E5 airspace designation listed in this document will be published subsequently in the Order.

The FAA is amending Title 14 Code of Federal Regulations (14 CFR) part 71 by revising Class E airspace at Vandenberg AFB, CA. The FAA is taking this action to provide additional controlled airspace for Category E aircraft conducting circling maneuvers in conjunction with published Standard Instrument Procedures. This airspace change places aircraft in controlled airspace from final descent to runway and protects Category E aircraft while conducting a circling approach to land.

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. Therefore, this regulation: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under Department of Transportation Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this proposed rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Federal Register Document 71-39, Airspace Docket No. FAA-2005-23075; Airspace Docket No. 05-ASO-12, published on February 28, 2006, (71 FR 9908), established Class E5 airspace at Nicholasville, KY. An error was discovered in the geographic coordinates describing the Class E5 airspace area. What should have been latitude 37°52′17″ N, longitude, 84°36′38″ W, was publish as latitude 37°52′16″ N, longitude. 84°36′39″W. This action corrects that error.

Designations for Class E airspace areas extending upward from 700 feet or more above the surface of the earth are published in FAA Order 7400.9N, dated September 1, 2005, and effective September 16, 2005, which is incorporated by reference in 14 CFR 71.1. The Class E designations listed in this document will be published subsequently in the Order.

As published, the final rule contains an error which identifies an incorrect geographical position for the location of the Class E5 airspace area. Accordingly, pursuant to the authority delegated to me, the geographic coordinates for the Class E5 airspace area at Nicholasville, KY, incorporated by reference at § 71.1, 14 CFR 71.1, and published in the Federal Register on March 31, 2000, (65 FR 17133), is corrected by making the following correcting amendment.

On April 6, 2006, the FAA published in the Federal Register a notice of proposed rulemaking to modify the Control 1487L offshore airspace area in Alaska (71 FR 17389). Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal. No comments were received.

Offshore Airspace Areas are published in paragraph 6007 of FAA Order 7400.9N dated September 1, 2005 and effective September 15, 2005, which is incorporated by reference in 14 CFR 71.1. The Offshore Airspace Areas listed in this document will be published subsequently in the Order.

This action amends Title 14 Code of Federal Regulations (14 CFR) part 71 by modifying Control 1487L offshore airspace area, AK, by lowering the floor from 5,500 feet mean sea level (MSL) to as low as 700 feet MSL in the vicinity of the Sitka Rocky Gutierrez Airport, Merle K. Mudhole Smith Airport and Middleton Island Airport. This action will provide offshore airspace in the vicinity of Merle K. Mudhole Smith Airport, AK, by lowering the offshore airspace floor from 5,500 feet MSL to 1,200 feet MSL. Additionally, this action will re-designate the existing Class E airspace at Anchorage, AK, by extending Control 1487L airspace area westward to the 12-mile shoreline limit within the 149.5-mile radius associated with Anchorage, AK, Class E airspace, and clarify offshore airspace descriptions within already established domestic Class E airspace at Anchorage and Cordova. This action will provide additional controlled airspace for the safety of aircraft executing IFR operations at the Sitka Rocky Gutierrez, Merle K. Mudhole Smith, and Middleton Island Airports, and will correctly designate the existing Class E airspace for Anchorage and Cordova, AK.

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. Therefore, this regulation: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under Department of Transportation (DOT) Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this proposed rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

As part of this rule relates to navigable airspace outside the United States, the notice of this action is submitted in accordance with the International Civil Aviation Organization (ICAO) International Standards and Recommended Practices.

The application of International Standards and Recommended Practices by the FAA, Office of System Operations Airspace and AIM, Airspace & Rules, in areas outside the United States domestic airspace, is governed by the Convention on International Civil Aviation. Specifically, the FAA is governed by Article 12 and Annex 11, which pertain to the establishment of necessary air navigational facilities and services to promote the safe, orderly, and expeditious flow of civil air traffic. The purpose of Article 12 and Annex 11 is to ensure that civil aircraft operations on international air routes are performed under uniform conditions.

The International Standards and Recommended Practices in Annex 11 apply to airspace under the jurisdiction of a contracting state, derived from ICAO. Annex 11 provisions apply when air traffic services are provided and a contracting state accepts the responsibility of providing air traffic services over high seas or in airspace of undetermined sovereignty. A contracting state accepting this responsibility may apply the International Standards and Recommended Practices that are consistent with standards and practices utilized in its domestic jurisdiction.

In accordance with Article 3 of the Convention, state-owned aircraft are exempt from the Standards and Recommended Practices of Annex 11. The United States is a contracting state to the Convention. Article 3(d) of the Convention provides that participating state aircraft will be operated in international airspace with due regard for the safety of civil aircraft. Since this action involves, in part, the designation of navigable airspace outside the United States, the Administrator is consulting with the Secretary of State and the Secretary of Defense in accordance with the provisions of Executive Order 10854.

History

On April 13, 2006, the FAA published in the Federal Register a notice of proposed rulemaking to modify the Control 1234L offshore airspace area in Alaska (71 FR 19148). Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal. No comments were received.

Offshore Airspace Areas are published in paragraph 6007 of FAA Order 7400.9N dated September 1, 2005 and effective September 15, 2005, which is incorporated by reference in 14 CFR 71.1. The Offshore Airspace Areas listed in this document will be published subsequently in the Order.

This action amends Title 14 Code of Federal Regulations (14 CFR) part 71 by modifying Control 1234L Offshore Airspace Area, AK by lowering the floor to 700 feet AGL in the vicinity of the St. Paul Island Airport, AK, and 1,200 feet AGL within a 73-mile radius of the airport. The action is to establish controlled airspace to support IFR operations at the St. Paul Island Airport, Alaska. The FAA Instrument Flight Procedures Production and Maintenance Branch developed new instrument approach procedures for the St. Paul Island Airport. New controlled airspace extending upward from 700 feet AGL and 1,200 feet AGL in international airspace is created by this action.

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. Therefore, this regulation: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under Department of Transportation (DOT) Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this proposed rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

As part of this rule relates to navigable airspace outside the United States, the notice of this action is submitted in accordance with the International Civil Aviation Organization (ICAO) International Standards and Recommended Practices.

The application of International Standards and Recommended Practices by the FAA, Office of System Operations Airspace and AIM, Airspace & Rules, in areas outside the United States domestic airspace, is governed by the Convention on International Civil Aviation. Specifically, the FAA is governed by Article 12 and Annex 11, which pertain to the establishment of necessary air navigational facilities and services to promote the safe, orderly, and expeditious flow of civil air traffic. The purpose of Article 12 and Annex 11 is to ensure that civil aircraft operations on international air routes are performed under uniform conditions.

The International Standards and Recommended Practices in Annex 11 apply to airspace under the jurisdiction of a contracting state, derived from ICAO. Annex 11 provisions apply when air traffic services are provided and a contracting state accepts the responsibility of providing air traffic services over high seas or in airspace of undetermined sovereignty. A contracting state accepting this responsibility may apply the International Standards and Recommended Practices that are consistent with standards and practices utilized in its domestic jurisdiction.

In accordance with Article 3 of the Convention, state-owned aircraft are exempt from the Standards and Recommended Practices of Annex 11. The United States is a contracting state to the Convention. Article 3(d) of the Convention provides that participating state aircraft will be operated in international airspace with due regard for the safety of civil aircraft. Since this action involves, in part, the designation of navigable airspace outside the United States, the Administrator is consulting with the Secretary of State and the Secretary of Defense in accordance with the provisions of Executive Order 10854.

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

U.S. Federal, State, and local authorities have developed and are refining a comprehensive public health plan to prepare for, and respond to, the threat of terrorism and other potential public health emergencies. A critical element in responding to such emergencies is the ability to correctly and quickly identify the chemical, biological, radiological, or nuclear agents that may have caused, or may cause, human disease or injury. The devices included within the scope of this rule are those for the detection of agents that have the potential to be used in acts of chemical, biological, radiological, or nuclear terrorism, or that can lead to other potential public health emergencies. Examples of these agents include Bacillus anthracis (anthrax); Yersinia pestis (plague); ricin (a lethal chemical agent); and cobalt-60, a radiological material that could be used to build a dirty bomb. Although it is not possible to provide an all inclusive list of etiological agents that would be identified under conditions that meet the criteria described in this rule, critical biologic agents such as Category A Diseases/Agents (available at http://www.bt.cdc.gov/agent/agentlist-category.asp ) or specific chemical agents ( http://www.bt.cdc.gov/chemical/ ) that are used by the federal government for regulatory and emergency planning purposes, may serve as examples of the types of agents within the scope of this rule. Select agents as defined in 42 CFR 73.1, that would suggest a terrorism event or other public health emergency, may be considered as other examples. Most in vitro diagnostic devices used to identify such agents have been developed (and more are under development) by the Centers for Disease Control and Prevention (CDC), and the Department of Defense (DOD). Some nongovernment entities are also developing such in vitro diagnostic devices. In most instances, these are the only devices available to provide timely diagnostic information on the identity of these agents, although they may not yet have been approved or cleared by FDA.

Many of these devices have not yet been approved or cleared by FDA because clinical studies involving devices used for the identification of such agents frequently cannot be conducted. Studies may not be possible because natural exposure to these agents is rare or never occurs, and there may not be enough exposed subjects to enroll in a study. Studies also may not be possible because it is not ethical to expose healthy human volunteers to a life-threatening toxic substance or organism to determine the ability of the unapproved diagnostic device to correctly identify the agent. While these unapproved devices may not have been evaluated on specimens collected from human subjects, testing (procedural) validation and other analytical studies generally have been conducted (or are being conducted) by the sponsors.

Some of these devices may be under clinical investigation, while others may not have reached that stage of development. For purposes of this rule we are considering the term “investigational device” to include those devices being evaluated in a clinical investigation as well as those that are undergoing preclinical and/or analytical evaluation.

Given all of these facts, the agency believes that the use of these investigational diagnostic devices in limited circumstances is justified when the devices are needed to identify the causative agent in a potential public health emergency and thereby enable authorities to promptly provide appropriate care to those exposed, and to provide preventive therapies (if available) to others in the affected geographic region(s).

Under FDA's regulations informed consent must be obtained before an investigational in vitro diagnostic device may be used unless an exception under part 50 (21 CFR part 50) applies. Institutional review board (IRB) review and approval is also required, unless an exception under part 56 (21 CFR part 56) applies. Under the IRB regulations investigations may be reviewed by an IRB through a joint review process, reliance upon the review of another qualified IRB (e.g., at the research site, a central IRB, an independent or commercial IRB), or similar arrangements. (See 21 CFR 56.114.) Therefore, absent an applicable exception, investigational in vitro diagnostic devices used to identify chemical, biological, radiological, or nuclear agents in human specimens may only be used after obtaining informed consent from each subject whose specimen is tested, and with IRB review and approval.

If a terrorism event (such as dissemination of B. anthracis spores in the mail system in 2001) or other potential public health emergency occurs (such as the multistate outbreak of monkeypox in persons exposed to pet prairie dogs in 2003), the timely identification of the etiological agent may be critical to the lives of the affected subjects as well as to the general population who may also have been exposed. The risk to subjects and others exposed could be life-threatening, and difficult to assess and address without the use of these investigational devices. Identification of the agent could be delayed significantly or precluded while the investigator seeks to obtain informed consent. Also, in some cases, storing the specimen while awaiting consent could have an adverse effect on the specimen and compromise the test results. The consequences of delay could be catastrophic for subjects and for public health in general.

Consider the following possible scenario in which a terrorist event is not suspected until a public health laboratory cultures an unusual or rare organism. When a patient presents to a health care facility with symptoms suggesting a systemic microbial infection, blood and other specimens are typically collected to determine the identity of the causative organism. The clinical laboratory would determine that the specimens contain an unusual organism that cannot be identified by the tests available in that laboratory. Because many clinical laboratories do not have the capability or resources to identify unusual organisms or those to which humans are rarely exposed naturally, the organism (culture isolate) or collected specimen would be referred to a public health laboratory. The public health laboratory would use in vitro diagnostic devices, including those that are investigational, to try to identify the cultured organism or detect its presence directly in the specimen.

In this scenario, the referring laboratory would not have obtained informed consent when the specimen was collected because the person directing that the specimen be collected would not have known at the time that the infecting organism could be reliably identified only by using an investigational device. To obtain informed consent would require a number of steps and introduce unacceptable delays. The public health laboratory would have to contact the referring laboratory that collected the specimen or the physician who ordered the cultures in order to locate the subject (or the subject's legally authorized representative). Once located, the subject or the subject's legally authorized representative would need to be contacted, provided the informed consent information, and given the opportunity to ask questions and sign the informed consent document. The referring laboratory or health care facility would then have to notify the public health laboratory that informed consent had been obtained. Only at that point could testing be performed.

The scenario described in the previous paragraph is one example and is not the only set of circumstances in which this exception to informed consent might apply. The new exception would also apply if the event were not terrorism-related but was another type of potential public health emergency, such as sporadic outbreaks resulting from the spread of an emerging infectious agent that has the potential to cause a life-threatening situation, as in the case of Severe Acute Respiratory Syndrome (SARS) or the potential for a pandemic influenza virus strain. This rule would not apply in a situation which is not life-threatening or where there is a cleared or approved available alternative method of diagnosis that provides an equal or greater likelihood of saving the life of the subject, such as the in vitro diagnostic devices for identifying agents causing certain known sexually transmitted diseases such as Chlamydia trachomatis , Neisseria gonorrhoeae , human papillomavirus, human immunodeficiency virus, etc. The emergency nature of the event may or may not be suspected at the time the specimen is collected, and the laboratory involved may or may not be a public health laboratory. Finally, even if the nature of the event is suspected, the person collecting the specimen may not know the investigational status of the in vitro diagnostic device and thus would not know that informed consent should be obtained from the patient. These variables are examples and are not meant to be the exclusive circumstances in which this rule might apply. The exception has been constructed in somewhat general terms because we can not anticipate the circumstances of every emergency involving a chemical, biological, radiological, or nuclear agent that may occur.

The process for obtaining informed consent in the scenarios described previously would introduce dangerous delays or could compromise the effectiveness of the testing. This process would delay not only the diagnosis and possibly lifesaving treatment of the subject, but would also delay recognition of a terrorism event or other public health emergency, with serious public health consequences.

To avoid potentially dangerous delays in using investigational in vitro diagnostic devices to identify these agents, FDA is creating a new limited exception, within the restrictions of section 520(g)(3)(D) of the act (21 U.S.C. 360j(g)(3)(D)), from the requirement of informed consent. The exception applies to investigational in vitro diagnostic tests used to identify agents, when a specimen is collected without the recognition that an investigational test will have to be used.

Two exceptions from the general requirements for informed consent are described in § 50.23. Section 50.23(a) provides that informed consent shall be deemed feasible unless, before use of the test article, both the investigator and a physician who is not otherwise participating in the clinical investigation certify in writing all of the following: The human subject is confronted by a life-threatening situation necessitating the use of the test article; informed consent cannot be obtained from the subject because of an inability to communicate with, or obtain legally effective consent from, the subject; time is not sufficient to obtain consent from the subject's legally authorized representative; and there is available no alternative method of approved or generally recognized therapy that provides an equal or greater likelihood of saving the life of the subject. An inability to communicate in the context of § 50.23(a) means that the subject is in a coma or unconscious. (See 46 FR 8942 at 8946, January 27, 1981). Section 50.23(d) states that, under 10 U.S.C. 1107(f), the President may waive the prior informed consent requirement for the administration of an investigational new drug to armed forces personnel in connection with the personnel's participation in a particular military operation. The waiver is based on a finding by the President that obtaining consent is not feasible, is contrary to the best interests of the military personnel, or is not in the interests of national security (64 FR 54180, October 5, 1999). Currently FDA is re-examining this regulation in light of the recent amendment of 10 U.S.C. 1107 by the Ronald W. Reagan National Defense Authorization Act for Fiscal Year 2005 which changed the criteria that may be used by the President for waiving informed consent.

In addition, § 50.24 provides an exception from the informed consent requirements for emergency research. Section 50.24 is intended to permit the study of potential improvements in the treatment of life-threatening conditions where current treatment is unproven or unsatisfactory, in order to improve interventions and patient outcomes. The exception applies to limited research activities involving human subjects who are in need of emergency medical intervention, but cannot give informed consent because of their medical condition. (See 61 FR 51498 at 51499, October 2, 1996.) Section 50.24 is intended to be used in circumstances that are different than those described in this rule, i.e., planned clinical research of a specific investigational article that will be studied in a specific class of patients.

The situation described in this document does not meet the requirements of the current exceptions from the general requirements for informed consent in § 50.23. It does not satisfy the requirements of § 50.23(a) because the subject may be physically able to provide informed consent. It does not satisfy the requirements of § 50.23(d) because that exception applies only to administration of investigational drugs to military personnel by DOD. In addition, Section 50.24 is generally not applicable because, in the situations addressed in that section, subjects are not able to consent because of their medical condition. In contrast, in the situations addressed in this document, it is not the condition of the subject that prevents the subject from giving informed consent, but rather the fact that, by the time it is known that the laboratory needs to use an investigational device to identify the etiological agent, the subject is physically separated from the specimen, and there is not enough time to locate the subject or the subject's legally authorized representative and obtain informed consent.

FDA is creating a new exception from the general requirements for informed consent to address situations associated with preparing for, and responding to, chemical, biological, radiological, or nuclear terrorism or other potential public health emergencies. The exception applies when investigational in vitro diagnostic devices are used and the investigator is unable to obtain timely informed consent from subjects (or their legally authorized representatives) whose specimens are being tested. The new limited exception is applicable only when it is not feasible to obtain informed consent because, at the time the specimen is collected, it may not be known that an investigational device would need to be used on that specimen, and delay in diagnosis could be life-threatening to the subject.

This exception is contingent on several determinations that must be made before using the investigational device, and later certified in writing, by both the investigator and, if time permits, by a physician who is not otherwise participating in the clinical investigation. These determinations are:

• The human subject is confronted with a life-threatening situation necessitating the use of the investigational in vitro diagnostic device;

• Informed consent cannot be obtained from the subject because:

1. There was no reasonable way for the person directing that the specimen be collected to know at the time the specimen was collected, that there would be a need to use the investigational device on that specimen and;

2. Time is not sufficient to obtain consent from the subject without risking the life of the subject;

• Time is not sufficient to obtain consent from the subject's legally authorized representative; and

• There is no available alternative approved or cleared method of diagnosis to identify the chemical, biological, radiological, or nuclear agent that provides an equal or greater likelihood of saving the life of the subject.

Under this interim final rule, the investigator has 5 working days after using the investigational device to submit to the IRB these determinations as well as the review and evaluation of an independent licensed physician. However, if, in the opinion of the investigator, there is not sufficient time to obtain the determination of an independent licensed physician in advance of using the investigational device, the independent physician is required to review and evaluate the determinations of the investigator and the investigator is required to submit this documentation to the IRB within 5 working days after using the device.

Until the investigational in vitro diagnostic device is used, it will not be known whether there has been actual exposure to a chemical, biological, radiological, or nuclear agent and whether that agent is life-threatening. Nonetheless, FDA believes the possibility of such exposure itself represents a life-threatening situation for the subject because, until the investigational in vitro diagnostic device is used, it is unknown to what agent, if any, the subject has been exposed or how the subject should be treated.

FDA expects that in accordance with routine clinical practice, the investigator will provide the test results obtained using the investigational in vitro diagnostic device to the subject's health care provider and that the results will be used in the clinical management of the human subject. It is possible that, in certain circumstances, the test results will also be reported to the appropriate public health authorities. This reporting will occur when appropriate and/or required by State or Federal law. Under the regulation, at the time the result of the test is reported (whether to the subject's health care provider and/or to the appropriate public health officials), the investigator is required to disclose the investigational status of the device used to perform the diagnostic test.

The investigator is also responsible for providing the IRB with the information required in § 50.25, the elements of informed consent, and the procedures that will be used to provide this information to each subject or to the subject's legally authorized representative. Section 50.25(a) requires that the following information be provided to each subject:

• A statement that the study involves research and an explanation of its purposes and the expected duration of the subject's participation;

• A description of the procedures to be followed, and identification of any procedures which are experimental;

• A description of any reasonably foreseeable risks or discomforts to the subject;

• A description of any benefits to the subject or others which may be reasonably expected from the research;

• A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;

• A statement of the extent, if any, to which confidentiality of records identifying the subject will be maintained and that notes the possibility that FDA may inspect the records;

• For more than minimal risk research, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained; and

• An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject.

Section 50.25(b) requires this additional information when it is appropriate:

• A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable;

• Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent;

• Any additional costs to the subject that may result from participation in the research;

• The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;

• A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation; and

• The approximate number of subjects involved in the study. This information will be provided at the time the test results are sent to the subject's health care provider and to public health authorities, if public health reporting is required by Federal, State, or local law.

In this rule, we are requiring investigators to provide all information described in § 50.25 except the information in § 50.25(a)(8) concerning voluntary participation. Normally under the regulations subjects voluntarily agree to participate in research before the research begins. In the circumstances covered by this rule, an individual provides a specimen for diagnostic testing without the knowledge of either the patient or the physician that an investigational in vitro diagnostic (IVD) will be necessary. When the investigational IVD is used at a setting remote from the patient and treating physician in this case, it is not practicable (because of the time and distance involved to contact the patient or the patient's legally authorized representative) to obtain consent for the use of the device. Under this rule, by the time the patient is informed that an investigational device has been used to test his/her specimen, the investigation is already underway, and the time at which a subject would normally consent to voluntary participation has past. Therefore, the investigator is not responsible for providing the information described in § 50.25(a)(8) concerning voluntary participation. In addition, subjects or their legally authorized representatives will not be entitled to withdraw previously collected data from the research database, because it is critical that FDA obtain and have available for review all data on the investigational in vitro diagnostic device's use in order to determine whether it is safe and effective. As a result, it is the responsibility of the IRB to ensure the adequacy of the information required in § 50.25 (except for the requirements under § 50.25(a)(8)) concerning voluntary participation) and to ensure that procedures for providing this information to the subject or the subject's legally authorized representative are in place. The IRB is responsible for this even if an exception under § 56.104(c) exists under which the emergency use of the test article would be reported to the IRB within 5 working days. We recognize that, in this situation, the IRB may be delayed in assuring that these procedures are in place.

According to the Office for Human Research Protection (OHRP) in the Department of Health and Human Services (HHS), some of the activities described in this rule may also constitute non-exempt human subjects research within the meaning of 45 CFR part 46. In particular, the use of the investigational in vitro diagnostic device on individually identifiable human specimens as described in this rule would not be human subjects research under 45 CFR part 46, while the analysis of the individually identifiable data obtained from the use of the investigational device to determine the safety and effectiveness of the device would be considered human subject research under 45 CFR part 46. If the analysis of individually identifiable data involves non-exempt human subjects research that is conducted or supported by HHS, the institution conducting the analysis must obtain an OHRP-approved assurance. In addition, this means that this research activity, if not exempt, i.e., the analysis of the individually identifiable data, must be reviewed prospectively by an IRB and must be conducted with the informed consent of the subjects unless waived. OHRP expects that IRBs will often find that informed consent may be waived under 45 CFR 46.116(d) for the analysis of the individually identifiable data obtained through the use of the investigational device. OHRP is issuing guidance regarding this issue simultaneously with the publication of this interim final rule which can be found at http://www.hhs.gov/ohrp/policy/index.html . Those interested in seeking additional information concerning the application of the regulations at 45 CFR part 46 should contact OHRP. We note that research conducted or supported by another department or agency may be subject to other laws and regulations. Sponsors should check to see if they are complying with all applicable requirements.

FDA believes the statutory authority provided in section 520(g)(3)(D) of the act permits this limited exception to obtaining informed consent for the use of investigational in vitro diagnostic devices to identify chemical, biological, radiological, or nuclear agents in potential terrorism events or other potential public health emergencies. Section 520(g)(3)(D) of the act specifically states when an exception from informed consent is permissible. Under section 520(g)(3)(D) of the act, informed consent is required unless the investigator determines the following in writing: (1) There exists a life threatening situation involving the human subject of such testing which necessitates the use of such device; (2) it is not feasible to obtain informed consent from the subject; and (3) there is not sufficient time to obtain such consent from the subject's legally authorized representative. Further, a licensed physician uninvolved in the testing must agree with this three-part determination in advance of using the device unless use of the device is required to save the life of the human subject of such testing, and there is not sufficient time to obtain such concurrence.

As noted earlier, FDA believes that, if the presence of an agent is suspected, there exists a life-threatening situation for the subjects whose specimens have been sent to laboratories. Until the laboratory identifies the agent to which the subject has been exposed or by which the subject has been infected, specific treatment cannot be provided. However, this limited exception applies only if it is also not feasible to obtain informed consent because there is an inability to communicate, in a timely manner, with the subject or the subject's legally authorized representative, and there was no reasonable way to know, at the time the specimen was collected, that there would be a need to use the investigational device on that specimen. In such a situation, the act would permit a limited exception to obtaining informed consent.

In accordance with section 521 of the act (21 U.S.C. 360k), state or local requirements that are different from, or in addition to, the requirements in this rule are expressly preempted. This rule establishes a new exception from the general requirements for informed consent, to permit the use of investigational in vitro diagnostic devices to identify chemical, biological, radiological, or nuclear agents without informed consent in certain circumstances. Consequently, State and local laws that require that informed consent be obtained in those situations are preempted.

FDA is proceeding without notice and comment rulemaking because the Nation needs to have this regulation in place immediately to be prepared to deal effectively with a terrorism event or other potential public health emergency. Under the provisions of the Administrative Procedure Act at 5 U.S.C. 553(b)(B), FDA finds for good cause that prior notice and comment on this rule are impracticable and contrary to the public interest. The absence of this exception was an impediment to the most efficient and effective public health response to the SARS outbreak. We do not want the absence of such an exception to be an impediment to our response to an outbreak of Avian flu or some other public health emergency. It is critical that FDA act quickly now to ensure that, in the future, individuals who may have been exposed to a chemical, biological, radiological, or nuclear agent have the benefit of the timely use of the most appropriate diagnostic devices, including those that are investigational. For the same reasons, the agency is making this interim final rule effective as of the date of publication.

The agency has determined under 21 CFR 25.30(h) that this interim final rule is of a type that does not, individually or cumulatively, have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

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

The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because this interim final rule provides an exception from an otherwise applicable requirement for investigators, FDA believes that it does not impose a significant burden. The agency therefore certifies that this rule will not have a significant economic impact on a substantial number of small entities.

Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before issuing “any rule that includes any Federal mandate that may result in an expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $115 million, using the most current (2003) Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this interim final rule to result in any 1-year expenditure that would meet or exceed this amount.

This interim final rule contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). The information collection requirements for this interim final rule have been approved under the emergency processing provisions of the PRA. The assigned OMB approval number for this collection of information is 0910-0586. This approval expires on November 30, 2006.

A description of these provisions is given in the following paragraphs with an estimate of the annual reporting burden. Included in the estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing each collection of information.

FDA invites comments on the following topics: (1) Whether the collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility: (2) the accuracy of FDA's estimate of the burden of the collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

Description : This interim final rule amends FDA's informed consent regulation to provide an exception from the general requirement to obtain informed consent from the subject of an investigation involving an unapproved or not cleared in vitro diagnostic device intended to identify a chemical, biological, radiological, or nuclear agent. For the exception to apply, it is necessary for the investigator and an independent licensed physician to make the determination and certify in writing certain facts concerning the need for use of the investigational in vitro diagnostic device without informed consent. The investigator submits this written certification to the IRB. When reporting the test results to the subject's health care provider and, possibly, to the appropriate public health authorities, the investigator must disclose the investigational status of the in vitro diagnostic device. The investigator must also provide the IRB with the information required in § 50.25 and the procedures that will be used to provide this information to each subject or the subject's legally authorized representative at the time the test results are provided to the subject's health care provider and possibly to the public health authorities.

Description of Respondents : Clinical laboratories, physicians.

FDA estimates the burden of the collection of information as follows:

FDA is adding § 50.23(e)(1) to provide an exception to the general rule that informed consent is required for the use of an investigational in vitro diagnostic device for the purpose of preparing for and responding to a chemical, biological, radiological, or nuclear terrorism event or other public health emergency, if the investigator and an independent licensed physician make the determination and later certify in writing that: (1) There is a life-threatening situation necessitating the use of the investigational device; (2) obtaining informed consent from the subject is not feasible because there was no way to predict the need to use the investigational device when the specimen was collected, and there is not sufficient time to obtain consent from the subject or the subject's legally authorized representative; and (3) no satisfactory alternative device is available. Under this interim final rule these determinations are made before the device is used, and the written certifications are made within 5 working days after the use of the device. If use of the device is necessary to preserve the life of the subject and there is not sufficient time to obtain the determination of the independent licensed physician in advance of using the investigational device, § 50.23(e)(2) provides that the certifications must be made within 5 working days of use of the device. In either case, the certifications are submitted to the IRB within 5 working days of the use of the device. From its knowledge of the industry, FDA estimates that there are approximately 150 laboratories that could perform this type of testing. FDA estimates that in the United States each year there are approximately 450 naturally occurring cases of diseases or conditions that are identified in CDC's list of category ‘A’ biological threat agents. The number of cases that would result from a terrorist event or other public health emergency is uncertain. Based on its knowledge of similar types of submissions, FDA estimates that it will take about 2 hours to prepare each certification.

Section 50.23(e)(4) provides that an investigator must disclose the investigational status of the device and what is known about the performance characteristics of the device at the time test results are reported to the subject's health care provider and public health authorities. Under this interim final rule, the investigator provides the IRB with the information required by § 50.25 and the procedures that will be used to provide this information to each subject or the subject's legally authorized representative. Based on its knowledge of similar types of submissions, FDA estimates that it will take about 1 hour to prepare this information and submit it to the health care provider and, where appropriate, to public health authorities.

FDA has analyzed this interim final rule in accordance with the principles set forth in Executive Order 13132 on Federalism (64 FR 43255, August 10, 1999). FDA has concluded that the rule raises federalism implications because, in accordance with section 521 of the act, this rule preempts State and local laws that require that informed consent be obtained before an investigational in vitro diagnostic device may be used to identify a chemical, biological, radiological, or nuclear agent in suspected terrorism events and other potential public health emergencies that are different from, or in addition to, the requirements of this regulation.

In accordance with the Executive order, preemption of State law is restricted to the minimum level necessary to achieve the objective of the statute to protect the public health by ensuring that individuals who may have been exposed to such an agent are able to benefit from the timely use of the most appropriate diagnostic devices, including those that are investigational. Also in accordance with the Executive order, officials at FDA consulted with the States on the effect of this rule on State law.

The new exception from informed consent is available in a very narrowly defined set of circumstances. Under these circumstances, a specimen already would have been taken from the individual. The individual would not be subjected to any further specimen collection or other procedure in order for the investigational device to be used on the specimen. In addition, in the circumstances in which the exception would apply, it is not only the health of the individual from whom the specimen was taken that would be at risk. It is possible that other people, perhaps many other people, would have been exposed to the chemical, biological, radiological, or nuclear agent as well.

In conclusion, the agency believes that it has complied with all of the applicable requirements under Executive Order 13132 and has determined that this final rule is consistent with the Executive order.

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. This regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988.

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

In accordance with section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360c(f)(1)), devices that were not in commercial distribution before May 28, 1976, the date of enactment of the Medical Device Amendments of 1976 (the amendments), generally referred to as postamendments devices, are classified automatically by statute into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval, unless the device is classified or reclassified into class I or class II, or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the act, to a predicate device that does not require premarket approval. The agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of FDA's regulations.

Section 513(f)(2) of the act provides that any person who submits a premarket notification under section 510(k) of the act for a device that has not previously been classified may, within 30 days after receiving an order classifying the device in class III under section 513(f)(1) of the act, request FDA to classify the device under the criteria set forth in section 513(a)(1) of the act. FDA shall, within 60 days of receiving such a request, classify the device by written order. This classification shall be the initial classification of the device. Within 30 days after the issuance of an order classifying the device, FDA must publish a notice in the Federal Register announcing such classification (section 513(f)(2) of the act).

In accordance with section 513(f)(1) of the act, FDA issued an order on May 27, 2004, classifying the HealthCheck TM Home Test for Loss of the Sense of Smell into class III, because it was not substantially equivalent to a class I or class II device that was introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, or a device which was subsequently reclassified into class I or class II. On July 28, 2004, FMG Innovations, Inc., submitted a request for classification of the HealthCheck TM Home Test for Loss of the Sense of Smell under section 513(f)(2) of the act (Ref. 1). The manufacturer recommended that the device be classified into class I.

In accordance with section 513(f)(2) of the act, FDA reviewed the petition in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the act. In general, devices are to be classified into class I if general controls, by themselves are sufficient to provide reasonable assurance of safety and effectiveness. Devices are to be classified into class II if general controls, by themselves, are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use. After review of the information submitted in the petition, FDA determined that the HealthCheck TM Home Test for Loss of the Sense of Smell should be classified into class II with the establishment of special controls. FDA believes that special controls, in addition to general controls, are necessary to provide reasonable assurance of safety and effectiveness of the device, and there is sufficient information to establish special controls to provide such assurance.

The device is assigned the generic name “olfactory test device,” and it is identified as a device used to determine whether a loss of olfactory function is present. The device includes one or more odorants that are presented to the patient's nose to subjectively assess olfactory function (i.e., the patient's ability to perceive odors). This device is not intended for the screening or diagnosis of diseases or conditions other than the loss of olfactory function.

FDA has identified the risks to health associated with this type of device as failure to detect olfactory sensory loss and user error. FDA believes that the class II special controls guidance document will aid in mitigating the potential risks to health by providing recommendations for the validation of performance characteristics and labeling. FDA believes that the special controls guidance document, in addition to general controls, addresses the risks to health identified previously and provides reasonable assurance of the safety and effectiveness of the device. Therefore, on March 27, 2006, FDA issued an order to the petitioner classifying the device into class II. FDA is codifying this classification at § 874.1600.

Following the effective date of the final classification rule, manufacturers will need to address the issues covered in this special control guidance. However, the manufacturer need only show that its device meets the recommendations of the guidance or in some other way provides equivalent assurances of safety and effectiveness.

Section 510(m) of the act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) of the act, if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. FDA has determined that premarket notification is not necessary to assure the safety and effectiveness of olfactory test devices when intended to determine whether an olfactory loss is present.

The agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

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

The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because classification of this device into class II will relieve manufacturers of the cost of complying with the premarket approval requirements of section 515 of the act (21 U.S.C. 360e), and may permit small potential competitors to enter the marketplace by lowering their costs, the agency certifies that the final rule will not have a significant economic impact on a substantial number of small entities.

Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing ``any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.'' The current threshold after adjustment for inflation is $115 million, using the most current (2003) Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this final rule to result in any 1-year expenditure that would meet or exceed this amount.

FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the agency has concluded that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.

This final rule contains no collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) is not required. FDA concludes that the special controls guidance document contains information collection provisions that are subject to review and clearance by OMB under the PRA. Elsewhere in this issue of the Federal Register , FDA is publishing a notice announcing the availability of the guidance document entitled “Class II Special Controls Guidance Document Olfactory Test Device.” The notice contains an analysis of the paperwork burden for the guidance.

The following references have been placed on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday.

On March 22, 2006, we published a notice of proposed rulemaking (NPRM) entitled Special Local Regulations for Marine Events; Onslow Bay, Beaufort Inlet, Morehead City State Port, Beaufort Harbor and Taylor Creek, NC in the Federal Register (71 FR 14428). We received no letters commenting on the proposed rule. No public meeting was requested, and none was held.

During the period 30 June to July 5, 2006, Pepsi Americas' Sail 2006 LLC will host the North Carolina port call of the “Pepsi Americas” Sail 2006”. A parade of sails and tall ships racing event are planned during this period to be conducted on the waters adjacent to Onslow Bay, Beaufort Inlet and the inland waters of Morehead City State Port and Beaufort Harbor, North Carolina. The first event will be the “Tall Ships Parade of Sails” on July 1, 2006 that will commence in Anchorage Area “ALFA” as depicted on NOAA Chart 11545 “Beaufort Inlet and Part of Core Sound”, and will enter Beaufort Inlet Channel at Beaufort Inlet Channel Lighted Buoy 7 and Beaufort Inlet Channel Lighted Buoy 8, and will proceed inbound to the Morehead City State Port turning basin thence to Beaufort Harbor Channel to Beaufort Harbor waterfront. The second event will be the “Tall Ships Race”, on July 3, 2006 that will take place on Onslow Bay from Beaufort Inlet Channel and continuing west approximately 11 nautical miles to a line drawn along longitude 076-54′ W. Because of the danger posed by numerous sailing vessels maneuvering in close proximity of each other during the proposed parade and race, special local regulations are necessary. For the safety concerns noted and to address the need for vessel control and vessel security, traffic will be temporarily restricted to provide for the safety of participants, spectators and transiting vessels.

The Coast Guard did not receive comments in response to the notice of proposed rulemaking (NPRM) published in the Federal Register . Accordingly, the Coast Guard is establishing temporary special local regulations on specified waters of Onslow Bay, Beaufort Inlet, Morehead City State Port, Beaufort Harbor and Taylor Creek, North Carolina.

This temporary 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. It is not “significant” under the regulatory policies and procedures of the Department of Homeland Security (DHS).

We expect the economic impact of this rule to be so minimal that a full Regulatory Evaluation under the regulatory policies and procedures of DHS is unnecessary.

Although this temporary regulation will prevent traffic from transiting a segment of the Onslow Bay, Beaufort Inlet, Morehead City State Port and Beaufort Harbor during these events, the effect of this regulation will not be significant due to the limited duration that the regulated area will be enforced. Extensive advance notifications will be made to the maritime community via Local Notice to Mariners, marine information broadcasts, area newspapers and local radio stations, so mariners can adjust their plans accordingly.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this temporary 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 would not have a significant economic impact on a substantial number of small entities. This temporary rule would affect the following entities, some of which might be small entities: The owners or operators of vessels intending to transit these sections of the Onslow Bay, Beaufort Inlet, Morehead City State Port, Beaufort Harbor Channel and Taylor Creek during these events.

This temporary rule would not have a significant economic impact on a substantial number of small entities for the following reasons. This rule would be in effect for only a limited period. Although the regulated area will apply to two separate segments within and around the waters of Onslow Bay, Beaufort Inlet, Morehead City State Port and Beaufort Harbor, traffic may be allowed to pass through the regulated areas with the permission of the Coast Guard Patrol Commander. In the case where the Patrol Commander authorizes passage through a regulated area during an event, vessels shall proceed at the minimum speed necessary to maintain a safe course that minimizes wake near the event. Although this regulation prevents traffic from transiting the Onslow Bay, Beaufort Inlet, Morehead City State port and Beaufort Harbor Bay during these event, the effect of this regulation will not be significant because of its limited duration. Before the enforcement period, the Coast Guard will issue maritime advisories so mariners can adjust their plans accordingly.

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 section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this temporary rule so that they can better evaluate its effects on them and participate in the rulemaking. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the address listed under ADDRESSES . 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 temporary 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 temporary 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 temporary 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 temporary 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 create an environmental risk to health or risk to safety that might disproportionately affect children.

This temporary 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 temporary 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 temporary 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)(h), of the Instruction, from further environmental documentation. Special local regulations issued in conjunction with a regatta or marine parade permit are specifically excluded from further analysis and documentation under that section.

Under figure 2-1, paragraph (34)(h), of the Instruction, an “Environmental Analysis Check List” and a “Categorical Exclusion Determination” are not required for this rule.

The Coast Guard is implementing certain permanent safety zones in 33 CFR 165.907 (published May 21, 2001, in the Federal Register , 66 FR 27868), for fireworks displays in the Captain of the Port Detroit Zone during June 2006. The following safety zones will be enforced during the times indicated below:

(1) Bay-Rama Fishfly Festival, New Baltimore, MI. Location: All waters off New Baltimore City Park, Lake St. Clair-Anchor Bay bounded by the arc of a circle with a 300-yard radius with its center located at approximate position 42°41′ N, 082°44′ W, on June 22, 2006, from 9 p.m. to 11 p.m.

(2) St. Clair Shores Fireworks, St. Clair Shores, MI. Location: All waters of Lake St. Clair within a 300-yard radius of the fireworks barge in approximate position 42°32′ N, 082°51′ W, about 1000 yards east of Veterans Memorial Park (off Masonic Rd.), St. Clair Shores, MI on June 30, 2006, from 10:00 p.m. to 10:30 p.m.

(3) Sigma Gamma Assoc., Grosse Pointe Farms, MI. Location: The waters off Ford's Cove, Lake St. Clair bounded by the arc of a circle with a 300-yard radius with its center in approximate position 42°27′ N, 082°52′ W on June 26, 2003 from 9 p.m. to 11 p.m.

In order to ensure the safety of spectators and transiting vessels, these safety zones will be in effect for the duration of the events. In the event that these safety zones affect shipping, commercial vessels may request permission from the Captain of the Port Detroit to transit through the safety zone.

Requests must be made in advance and approved by the Captain of Port before transits will be authorized. The Captain of the Port may be contacted via U.S. Coast Guard Group Detroit on channel 16, VHF-FM. The Coast Guard will give notice to the public via a Broadcast to Mariners that the regulation is in effect.

On January 19, 2006, we published a temporary final rule that created a temporary safety zone around the Grace Memorial and Silas Pearman Bridges on Hog Island Reach. (71 FR 3005) This safety zone includes all waters within the area bounded by the following coordinates: 32°48.566′ N, 079°55.211′ W to 32°48.389′ N, 079°54.256′ W to 32°47.824′ N, 079°54.401′ W thence to 32°47.994′ N, 079°55.359′ W.

Due to an administrative error, we published a second temporary safety zone for this location on May 25, 2006, at 71 FR 30062. This second temporary final rule has the same section number and establishes a safety zone at the same coordinates as the temporary final rule that published in January; however it has a different effective date and a slightly different title.

In order to avoid confusion and maintain the January effective date of the safe zone, we are removing the second temporary rule that published on May 25, 2006, at 71 FR 30062 and is entitled “Safety Zone; Cooper River, Hog Island Channel, Charleston, SC.”

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 rule is not a significant regulatory action because it removes a second temporary final rule has the same section number and establishes a safety zone at the same coordinates as the temporary final rule that published in January.

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, because it removes one of two duplicate temporary rules that establish safety zones on the navigable waters of Hog Island Reach on the Cooper River, for demolition of the Grace Memorial and Silas Pearman Bridges and associated recovery operations.

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 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. Under figure 2-1, paragraph (34)(g), of the Instruction, an “Environmental Analysis Check List” and a “Categorical Exclusion Determination” are not required for this rule, because this rule removes a duplicate temporary rule from the Code of Federal Regulations.

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 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers.

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

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

• Pesticide manufacturing (NAICS 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 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 .

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-2006-0297 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 7, 2006.

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-2006-0297, 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 Building), 2777 S. Crystal Drive, 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 telephone number is (703) 305-5805.

In the Federal Register of August 31, 2005 (70 FR 51802) (FRL-7733-1), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 5E4573) by IR-4, 681 U.S. Highway 1 South, North Brunswick, NJ 08902-3390. The petition requested that 40 CFR 180.421 be amended by establishing a tolerance for residues of the fungicide fenarimol [alpha-(2-chlorophenyl)-alpha-(4-chlorophenyl)-5-pyrimidinemethanol] in or on filbert at 0.02 parts per million (ppm). That notice included a summary of the petition prepared by Gowan Company, the registrant. There were no comments received in response to the notice of filing.

Section 408(b)(2)(A)(i) of 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 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 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 * * *.”

Consistent with section 408(b)(2)(D) of FFDCA, 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, consistent with section 408(b)(2) of FFDCA, for a tolerance for residues of fenarimol on filbert at 0.02 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance 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 toxic effects caused by fenarimol as well as the no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL) from the toxicity studies can be found at http://www.epa.gov/EPA-PEST/2002/December/Day-04/p30471.htm .

For hazards that have a threshold below which there is no appreciable risk, the dose at which no adverse effects are observed (the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor (UF) is applied to reflect 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.

The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify non-threshold hazards such as cancer. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk, estimates risk in terms of the probability of occurrence of additional cancer cases. More information can be found on the general principles EPA uses in risk characterization at http://www.epa.gov/pesticides/health/human.htm .

A summary of the toxicological endpoints for fenarimol used for human risk assessment is shown in Table 1 of this unit:

1. Dietary exposure from food and feed uses . Tolerances have been established (40 CFR 180.421)(a)(1) for the residues of fenarimol, [alpha-(2-chlorophenyl)-alpha-(4-chlorophenyl)-5-pyrimidinemethanol] for the following raw agricultural commodities (RACs): Apple at 0.1; apple, dry pomace at 2.0; apple, wet pomace at 2.0; cattle, fat at 0.1; cattle, kidney at 0.1; cattle, meat at 0.01; cattle, meat byproducts, except kidney at 0.05; goat, fat at 0.1; goat, kidney at 0.1; goat, meat at 0.01; goat, meat byproducts, except kidney at 0.05; horse, fat at 0.1; horse, kidney at 0.1; horse, meat at 0.01; horse, meat byproducts, except kidney at 0.05; pear at 0.1; pecan at 0.1; sheep, fat at 0.1; sheep, kidney at 0.1; sheep, meat at 0.01; and sheep, meat byproducts, except kidney at 0.05.

Tolerances have also been established (40 CFR 180.421)(a)(2) for the combined residues of fenarimol [alpha-(2-chlorophenyl)-alpha-(4-chlorophenyl)-5-pyrimidinemethanol] and its metabolites [alpha-(2-chlorophenyl)-alpha-(4-chlorophenyl)-1,4-dihydro-5-pyrimidinemethanol and 5-[(2-chlorophenyl) (4-chlorophenyl)methyl]-3,4-dihydro-4-pyrimidinol measured as the total of fenarimol and 5-[(2-chlorophenyl)-(4-chlorophenyl)methyl]pyrimidine (calculated as fenarimol) for the following RACs: Banana (import) at 0.5; cherry at 1.0; grape, juice at 0.6; grape pomace (wet and dry) at 2.0; grape at 0.2; grape, raisin, waste at 3.0; grape, raisin at 0.6. Risk assessments were conducted by EPA to assess dietary exposures from fenarimol 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. No such effects were identified in the toxicological studies for fenarimol, therefore a quantitative acute dietary exposure assessment is unnecessary.

ii. Chronic exposure . The chronic dietary exposure assessment for fenarimol is highly refined using anticipated residues based on 1996-1999 Food and Drug Administration (FDA) monitoring data for apples, bananas, cherries, grapes and pears. Field trial residue data were used for pecans and filberts. Percent crop treated (%CT) information and processing factors, where available, were used in the assessment. There were no PDP monitoring data available for fenarimol.

iii. Anticipated residue and percent crop treated (PCT) information . Section 408(b)(2)(E) of 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 chemicals 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. Following the initial data submission, EPA is authorized to require similar data on a time frame it deems appropriate. For the present action, EPA will issue such Data Call-Ins for information relating to anticipated residues as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Such Data Call-Ins 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 FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if the Agency can make the following findings: Condition 1, that 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; Condition 2, that the exposure estimate does not underestimate exposure for any significant subpopulation group; and Condition 3, if 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 FFDCA, EPA may require registrants to submit data on PCT.

The Agency used PCT information as follows:

Almonds 0.1%; apples 25%; bananas < 1%; cherries, sweet 13%; cherries, tart 9%; grapes, raisin 21%; grapes, table 8%; grapes wine 9%; hazelnuts 9%; pecans 1%; and pears 10%. These PCT figures were derived from a quantitative usage analysis (QUA) for fenarimol by the Agency based on data years 1990-1999. The weighted average of percent crop treated (%CT) was used for estimating chronic dietary exposure. Additional information on imported bananas was obtained indicating that less than 1% of bananas consumed in the United States are treated with fenarimol. For pecans, a default 1% crop treated was assumed (0% CT reported in QUA).

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 fenarimol may be applied in a particular area.

iv. Cancer . Fenarimol has been classified as a “not likely” human carcinogen (Group E) and thus a quantitative exposure assessment as to cancer risk is unnecessary.

2. Dietary exposure from drinking water . The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for fenarimol 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 physical characteristics of fenarimol.

Based on the First Index Reservoir Screening Tool (FIRST) and Screening Concentration in Groundwater models, the estimated environmental concentrations (EECs) of fenarimol chronic exposures are estimated to be 26 ppb for surface water and 16 ppb for ground 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).

Fenarimol is not registered for use on any sites that would result in exposure in or around the home. Fenarimol is registered for use on turf however,. Applications to turf are limited to golf courses, and stadium fields or professional athletic fields only. Therefore, the Agency has determined that the only potential non-occupational postapplication exposure is short-term dermal exposure to adult golfers.

EPA's “Standard Operating Procedures (SOPs) for Residential Exposure Assessments” at (http://www.epa.gov/fedrgstr/EPA-PEST/1999/January/Day-04/o-p34736.htm) were used to estimate the exposures of adult golfers contacting treated turf. The SOPs for turf use transfer coefficients based on mowing studies. Chemical specific data from a turf transferable residue (TTR) study were available; however, these TTR data were unacceptable for use in postapplication exposure assessment. Therefore, default assumptions from the SOPs were used. Exposures were estimated for short-term dermal contact with treated turf during the low contact activity of golfing. The exposure estimates generated for the golfing turf use is based on some upper-percentile assumptions (i.e., duration of exposure and maximum application rate for this short-term assessment) and is considered to be representative of high end exposures. The uncertainties associated with this assessment stem from the use of an assumed amount of pesticide retained on turf, and assumptions regarding the transfer of fenarimol residues. The turf risk estimate is believed to be a reasonable and protective estimate. Therefore, the level of confidence is fairly high, and does not under estimate risk.

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 fenarimol and any other substances and fenarimol does not appear to produce a toxic metabolite produced by other substances. EPA has also evaluated comments submitted that suggested there might be a common mechanism among fenarimol and other named pesticides that cause brain effects. EPA concluded that the evidence did not support a finding of common mechanism for fenarimol and the named pesticides. For the purposes of this tolerance action, therefore, EPA has not assumed that fenarimol 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 the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative .

1. In general . Section 408 of FFDCA provides that EPA shall apply an additional 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 data base on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans. 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 safety factor value based on the use of traditional uncertainty factors and/or special FQPA safety factors, as appropriate.

2. Prenatal and postnatal sensitivity . The developmental and reproductive toxicity studies showed no evidence of increased sensitivity or susceptibility of young rats or rabbits following prenatal or postnatal exposure to fenarimol. However, the studies demonstrated that fenarimol is associated with hydronephrosis that is reversible.

3. Conclusion . The data base for prenatal developmental and reproductive toxicity is considered complete. Based upon the RED completed June 2002, the Agency reduced the FQPA Safety factor from 10X to 3X. It was determined that the 3X would be retained until a special developmental toxicity study was received and reviewed to confirm if the potential hormonal effects elicited by inhibition of aromatase would result in effects in the rat pups. However more recently, fenarimol has been evaluated in studies considered in EPA's Endocrine Disruptor Screening Program including the Pubertal Female and Uterotrophic Assays. The Pubertal Female Assay involves the use of rats to screen for estrogenic and thyroid activity in females during sexual maturation, and examines abnormalities associated with sex organs and puberty markers, as well as thyroid tissue. The Uterotrophic assay involves the use of female rats to screen for estrogenic effects. In this in vivo assay, uterine weight changes are measured in ovariectomised or immature female rats.

No adverse effects were found in the female pubertal assay when SD rats were treated at 50 and 250 milligram/kilogram (mg/kg) day for 21 days, except for a decrease in T4 and an increase in circulating TSH levels. In the Uterotrophic assay, a dose of 200 mg/kg day results in a significant increase of uterine weights which were accompanied by an increase in serum FSH levels and a decrease in serum T3 levels. The uterotrophic response and the effects found on thyroid hormone levels are found at much higher doses than the regulatory endpoints based on the rat multi-generation study where fenarimol reduced fertility of males at 1.2 mg/kg per day with a NOAEL of 0.6 mg/kg per day. The 0.6 mg/kg NOAEL is over 300-fold lower than the uterotrophic response found in rats at 200 mg/kg.

In conclusion, there is greater confidence in the current NOAEL of 0.6 mg/kg per day given these recent studies on the reproductive, developmental and endocrine effects of fenarimol. It is therefore recommended that the 3X FQPA safety factor be removed because there are adequate data evaluating the potential endocrine effects of fenarimol during development and in the young animal. As a result, the Agency no longer requires a special developmental study.

1. Acute risk . No acute risk is expected from exposure to fenarimol since no acute endpoints were identified for the general U.S. population (including infants and children) or the females 13-50 years old population subgroup.

2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to fenarimol from food will utilize < 1% of the cPAD for the U.S. population, < 1% of the cPAD for all infants < 1 year old, and < 1% of the cPAD for children 1-6 years old. There are no residential uses for fenarimol that result in chronic residential exposure to fenarimol. In addition, there is potential for chronic dietary exposure to fenarimol in drinking water. After calculating Drinking Water Level of Comparison (DWLOCs) and comparing them to the EECs for surface water and ground water, infants and children, the most sensitive population subgroups slightly exceed the chronic DWLOC of 20. However, the chronic EECs were estimated using Tier I modeling and only slightly exceed the DWLOC. Additional data are being required that will provide important information on the mobility of fenarimol and its degradates. These studies will help to refine the chronic surface and ground water drinking water risk assessments.

The EECs are based on a Tier 1 model FIRST for a turf use scenario with maximum application rates. The estimated EEC for surface water is a very conservative estimate. It represents the 1-in-10 year mean yearly surface water concentration. The Agency's surface water modeling for drinking water uses a default percent cropped area factor (PCA) for turf, which represents the fraction of the watershed that is cropped and treated with the pesticide being modeled. In the absence of a crop-specific PCA factor, a default PCA of 0.87 is used. The 0.87 factor represents the maximum fraction of a watershed in the US that is agriculturally cropped. This default PCA was used for fenarimol modeling on turf. The Agency is currently attempting to develop PCA factors specific for turf scenarios, and recognizes that it is unlikely that 87% of a watershed used for drinking water would be grown to turf and treated with fenarimol at the maximum rate allowed only for turf applications especially since applications to turf are limited to golf courses, and stadium fields or professional athletic fields only.

The default PCA factor assumed and used in fenarimol modeling is most likely overestimated and adds to the conservatism of the assessment. Given the relatively low usage of fenarimol across the country it is highly unlikely that the amount applied to the watershed in the model will be concentrated in any real watershed used to derive drinking water. Therefore, the EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in Table 2 of this unit. The results indicated in the table below are based upon the RED, and are considered over estimates. Therefore, the risk estimates shown below are actually lower than what the table reports.

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). Fenarimol is currently registered for use that could result in short-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic food and water and short-term exposures for fenarimol. Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded that food and residential exposures aggregated result in aggregate MOE of 1,400 for adult golfers. This aggregate MOE does not exceed the Agency's level of concern for aggregate exposure to food and residential uses.

4. Aggregate cancer risk for U.S. population . Fenarimol has been classified as a “not likely” human carcinogen (Group E).

5. 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, and to infants and children from aggregate exposure to fenarimol residues.

Adequate methods are available for data collection and enforcement of tolerances for residues of fenarimol per se in/on plants and livestock. Adequate methods are also available for determination of residues of fenarimol and Metabolites B and C in plants Pesticide Analytical Manual (PAM) Volume II, Methods I (AM-AA-CA-R039-AB-755), II (AM-AA-CA-R072-AA-755), and III (AM-AA-CA-R124-AA-755.

There is no CODEX maximum residue limit for filbert.

Therefore, the tolerance is established for residues of fenarimol, [alpha-(2-chlorophenyl)-alpha-(4-chlorophenyl)-5-pyrimidinemethanol], in or on filbert at 0.02 ppm.

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 due to its lack of significance, 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). 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. , or 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). 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); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). 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). 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. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

The Congressional Review Act, 5 U.S.C. 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of 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:

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

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

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

• Pesticide manufacturing (NAICS 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 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 .

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-2005-0056 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 7, 2006.

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-2005-0056, 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 Building), 2777 S. Crystal Drive, 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 telephone number is (703) 305-5805.

In the Federal Register of March 19, 2001 (66 FR 15459) (FRL-6766-8), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 0E6083) by IR-4, 681 U.S. Highway 1 South, North Brunswick, NJ 08902-3390. The petition requested that 40 CFR 180.361 be amended by establishing a tolerance for combined residues of the herbicide pendimethalin, N-(1-ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine, and its metabolite 4-[(1-ethylpropyl)amino-2-methyl-3,5-dinitrobenyzl alcohol, in or on pistachio at 0.1 parts per million (ppm). That notice included a summary of the petition prepared by FMC Corporation, the registrant. There were no comments received in response to the notice of filing.

Section 408(b)(2)(A)(i) of 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 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 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.”

EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of the FFDCA and a complete description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm .

Consistent with section 408(b)(2)(D) of FFDCA, 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, consistent with section 408(b)(2) of FFDCA, for a tolerance for combined residues of pendimethalin, [N-(1-ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine], and its metabolite 4-[(1-ethylpropyl)amino]-2-methyl-3,5-dinitrobenyzl alcohol in or on pistachio at 0.1 ppm.

On April 12, 2006 the Agency published a Final Rule (71 FR 18628, FRL-7770-4) establishing tolerances for combined residues of pendimethalin, [N-(1-ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine], and its metabolite 4-[(1-ethylpropyl)amino]-2-methyl-3,5-dinitrobenyzl alcohol in or on almond, hulls; carrots; citrus, oil; Fruit, citrus, group 10; Nut, tree, group 14; peppermint, oil; peppermint, tops; spearmint, oil; and spearmint, tops. When the Agency conducted the risk assessments in support of this tolerance action it assumed that pendimethalin residues would be present on pistachio as well as on all foods covered by the proposed and established tolerances. Residues on pistachio were included because there was a pending application under the Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. 136 et seq ., to register pendimethalin on pistachio. Therefore, establishing the pistachio tolerance will not change the most recent estimated aggregate risks resulting from use of pendimethalin, as discussed in the April 12, 2006 Federal Register . Refer to the April 12, 2006 Federal Register document for a detailed discussion of the aggregate risk assessments and determination of safety. EPA relies upon those risk assessments and the findings made in the Federal Register document in support of this action.

Based on the risk assessments discussed in the final rule published in the Federal Register of April 12, 2006, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to pendimethalin residues.

Adequate methods are available for data collection and tolerance enforcement for existing and proposed uses of pendimethalin. Methods I through IV in the Pesticide Analytical Manuel (PAM) Vol. II are gas chromatography/electron capture (GC/ECD) methods. Methods used for data collection are essentially the same as the PAM Vol. II methods, and have been adequately validated.

The Food and Drug Administrations's PESTDATA data base (PAM Volume I, Appendix I) indicates that pendimethalin is completely recovered (<80%) by Multiresidue Methods Section 302 (Luke method; Protocol D) and 303 (Mills, Onley, Gaither method; Protocol E, nonfatty), and partially recovered (50-80%) by Multiresidue Method Section 304 (Mills fatty food method; Protocol E, fatty).

The method maybe 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 established or proposed Codex Maximum Residue Levels (MRLs) for pendimethalin residues. Therefore, there are no issues of compatibility with respect to Codex MRLs and U.S. tolerances.

Therefore, the tolerance is established for combined residues of pendimethalin, [N-(1-ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine], and its metabolite 4-[(1-ethylpropyl)amino]-2-methyl-3,5-dinitrobenyzl alcohol in or on pistachio at 0.1 ppm.

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 due to its lack of significance, 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). 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. , or 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). 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); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). 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). 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. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

The Congressional Review Act, 5 U.S.C. 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of 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:

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

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

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

• Pesticide manufacturing (NAICS 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 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 .

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-2006-0404 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 7, 2006.

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-2006-0404, 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 Building), 2777 S. Crystal Drive, 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 telephone number is (703) 305-5805.

In the Federal Register of August 13, 2004 (69 FR 50192) (FRL-7364-9), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 3F6794) by DowAgroSciences, 9330 Zionsville Road 308-2E225, Indianapolis, IN 46268-1054. The petition requested that 40 CFR 180.544 be amended by establishing a tolerance for residues of the insecticide methoxyfenozide per se; benzoic acid, 3-methoxy-2-methyl-, 2-(3,5-dimethylbenzoyl)-2-(1,1-dimethylethyl) hydrazide, in or on soybean aspirated grain at 200 parts per million (ppm), soybean forage at 45 ppm, soybean hay at 65 ppm, soybean hulls at 3.0 ppm, soybean meal at 0.1 ppm, soybean oil at 1.0 ppm, and soybean seed at 2.0 ppm. That notice included a summary of the petition prepared by Dow AgroSciences, the registrant. There were no comments received in response to the notice of filing.

The registrant subsequently revised Section F of the petition to concur with the tolerances found to be supported by the Agency based on the available data used for the risk assessment. In the revised Section F, Dow AgroSciences requested that 40 CFR 180.544 be amended by establishing a tolerance for residues of the insecticide methoxyfenozide per se; benzoic acid, 3-methoxy-2-methyl-, 2-(3,5-dimethylbenzoyl)-2-(1,1-dimethylethyl) hydrazide, in or on soybean aspirated grain at 160 ppm, soybean forage at 30 ppm, soybean hay at 80 ppm, soybean hulls at 2.0 ppm, and soybean seed at 1.0 ppm.

Section 408(b)(2)(A)(i) of 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 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 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. . . .”

EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of FFDCA and a complete description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm .

Consistent with section 408(b)(2)(D) of FFDCA, 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, consistent with section 408(b)(2) of FFDCA, for a tolerance for residues of methoxyfenozide on soybean aspirated grain at 160 ppm, soybean forage at 30 ppm, soybean hay at 80 ppm, soybean hulls at 2.0 ppm, and soybean seed at 1.0 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance 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 toxic effects caused by methoxyfenozide as well as the no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL) from the toxicity studies can be found at http://www.epa.gov/EPA-PEST/2002/September/Day-20/p23996.htm .

For hazards that have a threshold below which there is no appreciable risk, the dose at which no adverse effects are observed (the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor (UF) is applied to reflect 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.

The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify non-threshold hazards such as cancer. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk, estimates risk in terms of the probability of occurrence of additional cancer cases. More information can be found on the general principles EPA uses in risk characterization at http://www.epa.gov/pesticides/health/human.htm .

A summary of the toxicological endpoints for methoxyfenozide used for human risk assessment is shown in Table 1 of this unit:

1. Dietary exposure from food and feed uses . Tolerances have been established (40 CFR 180.544) for the residues of methoxyfenozide, in or on a variety of raw agricultural commodities, animal (cattle, goat, hog, horse, poultry, and sheep) meats and fats, and milk. Risk assessments were conducted by EPA to assess dietary exposures from methoxyfenozide 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. No appropriate endpoint was identified in the oral toxicity studies including the acute neurotoxicity study in rats and the developmental toxicity studies in rats and rabbits. Therefore, acute dietary exposure assessments were not conducted.

ii. Chronic exposure . In conducting the chronic dietary exposure assessment EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID TM ), which incorporates food consumption data as reported by respondents in the USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII), and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: Drinking water will contain the highest estimate drinking water concentration (EDWC), 100% of all existing and proposed crops are treated, and all resulting residues are at tolerance levels.

iii. Cancer . Because methoxyfenozide has been classified as “not likely to be a human carcenogen,” an exposure assessment for the purpose of assessing cancer risk is not needed.

2. Dietary exposure from drinking water . The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for methoxyfenozide 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 physical characteristics of methoxyfenozide. Further information regarding EPA drinking water models used in pesticide exposure assessment is discussed in Unit III.C.2 of the final rule previously published in the Federal Register of July 5, 2000 (65 FR 41355) (FRL-6496-5).

Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System and Screening Concentrations in Groundwater models, the estimated environmental concentrations (EECs) of methoxyfenozide for acute exposures are estimated to be 43 parts per billion (ppb) for surface water and 3.5 ppb for ground water. The EECs for chronic exposures are estimated to be 30 ppb, based on surface 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).

Methoxyfenozide 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 methoxyfenozide and any other substances and methoxyfenozide 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 methoxyfenozide 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 the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative .

1. In general . Section 408 of FFDCA provides that EPA shall apply an additional 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 data base on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a margin of exposure analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans. 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 safety factor value based on the use of traditional uncertainty factors and/or special FQPA safety factors, as appropriate.

2. Prenatal and postnatal sensitivity . There is no evidence of prenatal or postnatal sensitivity, as discussed in Unit IV.C. of the final rule previously published in the Federal Register of August 31, 2005 (70 FR 51597) (FRL-7732-3).

3. Conclusion . There is a complete toxicity data base for methoxyfenozide and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. The Agency has determined that the FQPA Safety Factor can be reduced to 1X in assessing the risk posed by this chemical. The basis for this determination is discussed in Unit IV.C.5 of the final rule previously published in the Federal Register of August 31, 2005.

1. Acute risk . No appropriate endpoint was identified in the oral toxicity studies including the acute neurotoxicity study in rats and the developmental toxicity studies in rats and rabbits. Therefore, no acute dietary risk is expected.

2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to methoxyfenozide from food and drinking water will utilize 23% of the cPAD for the U.S. population, 32% of the cPAD for all infants < 1-year old, and 56% of the cPAD for children 1-2 years old, the highest exposed subgroup. There are no residential uses for methoxyfenozide that result in chronic residential exposure to methoxyfenozide.

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

4. Aggregate cancer risk for U.S. population . Methoxyfenozide has been classified as “not likely” to be a human carcinogen. The classification is based on the lack of evidence of carcinogenicity in male and female rats as well as in male and female mice and on the lack of genotoxicity in an acceptable battery of mutagenicity studies. Therefore, methoxyfenozide is not expected to pose a cancer risk.

5. 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, and to infants and children from aggregate exposure to methoxyfenozide residues.

Adequate enforcement methodology (TR 34-00-28) was previously developed by Rohm and Haas; high performance liquid chromatography (HPLC) with positive ion electrospray (E.I.) tandem mass spectrometry (LC/MS/MS)) is available to enforce the tolerance expression. 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 established or proposed Codex, Canadian, or Mexican limits for residues of methoxyfenozide in or on plant or animal commodities. Therefore, no compatibility issues exist regarding the proposed U.S. tolerances.

Therefore, the tolerance is established for residues of methoxyfenozide per se; benzoic acid, 3-methoxy-2-methyl-2-(3,5- dimethylbenzoyl)-2-(1,1-dimethylethyl)hydrazide, in or on soybean aspirated grain at 160 ppm, soybean forage at 30 ppm, soybean hay at 80 ppm, soybean hulls at 2.0 ppm, and soybean seeds at 1.0 ppm. The original petition (PP 3F6794) and notice of filing (Docket identification number OPP-2004-0184) contained additional proposed tolerances for soybean, oil and soybean, meal. Dow AgroSciences the registrant submitted a revised Section F of the petition for the removal of soybean, oil and soybean, meal from the tolerance expression.

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 due to its lack of significance, 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). 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. , or 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). 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); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). 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). 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. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

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

This is a synopsis of the Commission's Report and Order, MB Docket No. 05-108, adopted May 17, 2006, and released May 19, 2006. The full text of this Commission decision is available for inspection and copying during normal business hours in the FCC Reference Information Center, Portals II, 445 12th Street, SW, Room CY-A257, Washington, DC 20554. The complete text of this decision also may be purchased from the Commission's duplicating contractor, Best Copy and Printing, Inc., 445 12th Street, SW, Room CY-B402, Washington, DC, 20554, (800) 378-3160, or via the company's Web site, http://www.bcpiweb.com. The Commission will send a copy of this Report and Order in a report to be sent to Congress and the Government Accountability Office pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A).

This is a synopsis of the Commission's Report and Order, MB Docket No. 06-19, adopted May 17, 2006, and released May 19, 2006. The full text of this Commission decision is available for inspection and copying during normal business hours in the FCC's Reference Information Center at Portals II, 445 12th Street, SW, Room CY-A257, Washington, DC, 20554. The document may also be purchased from the Commission's duplicating contractor, Best Copy and Printing, Inc., Portals II, 445 12th Street, SW, Room CY-B402, Washington, DC, 20554, telephone 1-800-378-3160 or http://www.BCPIWEB.com. The Commission will send a copy of this Report and Order in a report to be sent to Congress and the Government Accountability Office pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A).

This is a synopsis of the Report and Order in MB Docket No. 05-104, adopted May 17, 2006, and released May 19, 2006. 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. 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. The Commission will send a copy of this Report and Order in a report to be sent to Congress and the Government Accountability Office pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A).

Federal Motor Vehicle Safety Standard (FMVSS) No. 213, Child restraint systems , regulates child restraint systems used in motor vehicles and aircraft (49 CFR 571.213). Among other things, this standard specifies requirements for the webbing material used in child restraint systems, including requirements for the strength of the webbing after the webbing is subjected to abrasion (S5.4.1(a)), light exposure (S5.4.1(b)), and micro-organisms (S5.4.1(b)). 1 These specified conditions simulate the conditions that webbing will likely encounter through normal use. Evaluating the performance of the webbing after subjecting the webbing to those conditions better ensures the long-term integrity of the webbing.

Each of the requirements for exposed webbing is expressed in the form of a percent-of-strength of the webbing measured before exposure. S5.4.1(a) specifies that, after being subjected to abrasion as specified in certain sections of FMVSS No. 209, the webbing must have a breaking strength of not less than 75 percent of the strength of the unabraded webbing. S5.4.1(b) of FMVSS No. 213, referring to S4.2(e) in FMVSS No. 209, specifies that after being exposed to light, the webbing shall have a breaking strength of not less than 60 percent of the strength before exposure. The same section of FMVSS No. 213 also refers to S4.2(f) of FMVSS No. 209, which specifies that after being exposed to micro-organisms, the webbing shall have a breaking strength of not less than 85 percent of the strength before exposure to micro-organisms.

However, FMVSS No. 213 does not currently specify a minimum breaking strength for new webbing against which the percentages would be measured. Addressing this aspect of the standard, on June 30, 2005, we published the notice of proposed rulemaking (NPRM)(70 FR 37731; Docket No. NHTSA-2005-21243) preceding this final rule. In the NPRM, we expressed concern that because there is no specified minimum breaking strength for new webbing, manufacturers could use webbing of inferior strength to meet the standard's requirements. The exposed webbing might have a breaking strength that is within the specified percentage of the strength of the new webbing, but the webbing might not have an absolute strength high enough to provide a margin of safety for use throughout the life of a child restraint.

The NPRM sought to achieve three goals (70 FR at 37732). First was to specify a minimum breaking strength for unabraded webbing or webbing that has not been exposed to light or micro-organisms (hereinafter referred to as “new webbing”), to address the concern about a lack of a minimum breaking strength requirement for new webbing. Second was to affirm that a purpose of S5.4.1(a) and (b) of FMVSS No. 213 was to limit the degradation rate of the webbing. We stated that limiting degradation was done by having a minimum breaking strength requirement that applies to webbing that has been exposed to mechanical or environmental conditions in the test laboratory that accelerate the aging of the webbing. (Webbing that has been abraded or exposed to the accelerated conditions is referred to as “exposed webbing.”) We tentatively concluded that specifying minimum breaking strength requirements for new and exposed webbing would eliminate the need for the current percent-of-strength degradation requirements. Third was to clarify the weight used in the abrasion test to abrade the webbing used to attach child restraint systems to the child restraint anchorages located in a vehicle.

Table 1, below, summarizes the NPRM's proposed minimum breaking strength requirements for new and exposed webbing: (a) Used to attach the child restraint system to the vehicle (hereinafter “tether webbing”)  2 , and (b) used to restrain the child in the child restraint (hereinafter “harness webbing”). We proposed a more stringent requirement for tether webbing because tether webbing secures the mass of a child restraint and child, whereas harness webbing is limited to securing the mass of a child occupant.

The agency explained in the NPRM (70 FR at 37734) that the 15,000 N value for new tether webbing was based on a calculation of the loads imposed by the mass of a child and child restraint together, and on a consideration of the breaking strength previously required for seat belt assembly restraints for persons not weighing more than 50 pounds (Type 3 seat belt assemblies)  3 (70 FR at 37734). Type 3 webbing was required to meet a breaking strength in the range of approximately 13,000-18,000 N, depending on the number of webbing connections to attachment hardware. The agency believed that a 15,000 N requirement has a margin of safety above the minimum 13,000 N lower limit previously established for Type 3 webbing. We also noted that of 20 child restraint systems tested, 17 had tether webbing with a breaking strength of 15,000 N or greater, indicating that a 15,000 N requirement would be feasible. We further stated that we are unaware of real-world data that would indicate the presence of a safety problem associated with the strength levels of current webbing.

The NPRM proposed a minimum breaking strength of 11,000 N for new harness webbing. The 11,000 N proposal was based in part on the breaking strength requirements for Type 3 belt assemblies prior to 1979, which ranged from 1,500 pounds (6,670 N) for webbing in pelvic and upper torso restrains to 4,000 pounds ( 17,793 N) for webbing in seat back retainers. The proposal was also based on a consideration of compliance data for 109 child restraint systems collected from 2000-2002. Ninety-two percent (100 out of 109) of the harness webbing had a breaking strength above 11,000 N. Given also that there have been no real-world reports of harness webbing failures, the agency tentatively determined that the proposed requirement was reasonable.

The NPRM proposed to require tether and harness webbing to meet minimum strength requirements after abrasion, exposure to light, and exposure to micro-organisms, the same test conditions to which child restraint webbing is currently exposed. Currently in FMVSS No. 213, each of the post-exposure strength requirements is calculated from percentages of the strength of the original (new) webbing. The NPRM proposed not changing the percentages now used to calculate the post-exposure strength requirements (75 percent—abrasion, 60 percent—exposure to light, and 85 percent—exposure to micro-organisms). The proposed minimum strength requirements for the exposed webbing were calculated using those percentages, which were determined by the Society of Automotive Engineers (SAE) and incorporated into SAE Standard SAE J4c, Motor Vehicle Seat Belt Assemblies. The agency incorporated the SAE percentages and procedures into FMVSS No. 209 and FMVSS No. 213.

The king and Tanner crab fisheries in the exclusive economic zone of the Bering Sea and Aleutian Islands (BSAI) are managed under the FMP. The FMP was prepared by the North Pacific Fishery Management Council (Council) under the Magnuson-Stevens Act as amended by the Consolidated Appropriations Act of 2004 (Public Law 108-199, section 801). Amendments 18 and 19 to the FMP to implement the Program. A final rule implementing these amendments was published on March 2, 2005 (70 FR 10174). NMFS also published three corrections to the final rule (70 FR 13097; March 18, 2005), (70 FR 33390; June 8, 2005) and (70 FR 75419; December 20, 2005).

In October 2005, the Council adopted Amendment 20 to the FMP. The Notice of Availability for Amendment 20 was published in the Federal Register on February 27, 2006 (71 FR 9770). NMFS approved Amendment 20 on May 25, 2006.

NMFS published a proposed rule to implement Amendment 20 in the Federal Register on March 21, 2006 (71 FR 14153). Public comments on the proposed rule were solicited through May 5, 2006. No public comments were received and therefore, no changes were made from the proposed to final rule.

A description of this action is provided in the preamble to the proposed rule (March 21, 2006, 71 FR 14153) and is briefly summarized here. Under the Program, harvester quota share (QS), processor quota share (PQS), individual fishing quota (IFQ), and individual processing quota (IPQ) currently are issued for one Tanner crab fishery. The State of Alaska (State), however, has determined that eastern Bering Sea Tanner crab should be separated into two stocks and managed as two separate fisheries to avoid localized depletion by the commercial fishery, particularly of legal-sized males in the Pribilof Islands area. The Program and the final rule implementing it allocated shares of the Tanner crab fishery in the Bering Sea, but did not separately distinguish the management of these two stocks.

Amendment 20 to the FMP modifies the allocation of harvesting shares and processing shares for Bering Sea Tanner crab to accommodate management of geographically separate Tanner crab fisheries. This action allocates QS and PQS and the resulting IFQ and IPQ for two Tanner crab fisheries, one east of 166° W. longitude and the other west of 166° W. longitude. Revision of the QS and PQS allocations resolves the current inconsistency between current allocations and management of the Tanner crab species as two stocks. This change will reduce administrative costs for managers and the operational costs of harvesters and processors while increasing their flexibility.

This action does not alter the basic structure or management of the Program. Reporting, monitoring, fee collection, and other requirements to participate in the Tanner crab fishery are unchanged. This action does not increase the number of harvesters or processors in the Tanner crab fisheries or the amount of crab that may be harvested currently. This action does not affect regional delivery requirements or other restrictions on harvesting and processing Tanner crab that currently apply.

NMFS will reissue Tanner crab QS and PQS. Currently, Tanner crab is issued as Bering Sea Tanner (BST) QS and BST PQS. For each share of BST QS held, a person will be issued one share of eastern Bering Sea Tanner crab (EBT) QS, and one share of western Bering Sea Tanner crab (WBT) QS. Similarly, for each BST PQS held, a person will be issued one share of EBT PQS, and one share of WBT PQS. EBT QS and PQS would result in IFQ and IPQ that could be used for the Tanner crab fishery occurring east of 166° W. longitude; WBT QS and PQS would result in IFQ and IPQ that could be used for the Tanner crab fishery occurring west of 166° W. longitude. This reissuance of Tanner crab QS and PQS will not increase the number of initially issued Tanner crab quota holders. Tanner crab QS and PQS holders will receive IFQ and IPQ in a specific fishery only if that specific Tanner crab fishery has a harvestable surplus and a total allowable catch (TAC) assigned by the State.

NMFS will reissue Tanner crab QS and PQS after the end of the current Tanner crab fishing season (March 31, 2006), and prior to the date when the State announces the TACs for the 2006/2007 crab fishing seasons (October 1, 2006). This will reduce any potential conflict with the current Tanner crab fishery.

The Regional Administrator determined that Amendment 20 is necessary for the conservation and management of the Bering Sea crab fisheries and that it is consistent with the Magnuson-Stevens Act and other applicable laws.

NMFS prepared an FRFA which incorporates the IRFA, a summary of the analyses completed to support the action, and public comments received on the IRFA. A copy of this analysis is available from NMFS (see ADDRESSES ). The following summarizes the FRFA.

The FRFA evaluates the impacts of this rule. The FRFA addresses the statutory requirements of the Regulatory Flexibility Act (RFA) of 1980, as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996 (5 U.S.C. 601-612). It specifically addresses the requirements at section 604(a).

The proposed rule was published in the Federal Register on March 21, 2006 (71 FR 14153). An IRFA was prepared for the proposed rule, and described in the classifications section of the preamble to the rule. The public comment period ended on May 5, 2006. No public comment were received on the IRFA. No changes were made to the final rule from the proposed rule.

The reasons for this action and the objectives and legal basis for the rule are discussed in the preamble to this rule and are not repeated here.

The FRFA contains a description and estimate of the number of directly affected small entities. Estimates of the number of small harvesting entities under the Program are complicated by several factors. Each eligible captain will receive an allocation of QS under the Program. A total of 186 captains received allocations of Tanner crab QS for the 2005-2006 fishery. In addition, 269 allocations of QS to Limited License Program (LLP) license holders were made under the Program, for a total of 455 QS allocations in the Tanner crab fisheries. Because some persons participated as LLP holders and captains and others received allocations from the activities of multiple vessels, only 294 unique persons received QS. Of those entities receiving QS, 287 are small entities because they either generated $4.0 million or less in gross revenue, or they are independent entities not affiliated with a processor. Estimates of gross revenues for purposes of determining the number of small entities relied on the low estimates of prices from the arbitration reports based on the 2005/2006 fishing season.

Allocations of Tanner crab PQS under the Program were made to 20 processors. Of these PQS recipients, nine are estimated to be large entities, and 11 are small entities. Estimates of large entities were made based on available records of employment and the analysts' knowledge of foreign ownership of processing companies. These totals exclude catcher/processors, which are included in the LLP holder discussion.

The reporting, recordkeeping, and other compliance requirements of the final rule will not change from those of the Program with respect to QS, IFQ, PQS, and IPQ. As such, this action requires no additional reporting, recordkeeping, or other compliance requirements.

The EA/RIR/FRFA prepared for this action analyzed a suite of three alternatives for harvesters, and a separate suite of three alternatives for processors. Alternative 1 for harvesters and processors, the no action alternative, would maintain the existing inconsistency between Federal allocations supporting a single Tanner crab fishery and State management of two stocks of Tanner crab. For harvesters, the difference in effects of the revised allocation alternatives on the social and economic environment is primarily distributional. Under the preferred harvester alternative (Alternative 2), an eligible participant receives an allocation in both fisheries based on all qualifying catches regardless of where that catch occurred. Under harvester Alternative 3, a harvester would receive an allocation in each fishery based on historic catch from the area of the fishery. Under this alternative, a person's allocation would be skewed toward the area in which the person had greater catch relative to other participants.

For processors, the choice of revised allocation alternatives would have operational and efficiency effects. Under the preferred processor alternative (Alternative 2), PQS and IPQ pools are created for the two fisheries. Share holders can trade shares in the fisheries independently to establish long-term relationships in each fishery. Under processor Alternative 3, PQS would generate an annual allocation of IPQ that could be used in either fishery. Since TACs in the fisheries may fluctuate independently, harvesters that do not hold equal percentages of the pools in both fisheries will be unable to establish fixed long-term relationships with a processor for all their shares. Instead, these participants would need to modify their relationships if TACs change independently in the different Tanner crab fisheries. This restructuring of relationships could reduce efficiency in the Tanner crab fisheries by adding to transaction costs of participants.

Although the different allocations under consideration in this action would have distributional and efficiency impacts for individual participants, in no case are these aggregated impacts expected to be substantial. In all instances, similar numbers of participants would receive allocations.

Alternative 1 for harvesters would create inefficiencies for harvesters by failing to provide a mechanism to ensure that quota is managed for each stock separately in accordance with biomass distribution. Preferred Alternative 2 provides additional flexibility to industry participants to hold quota to fish specific Tanner crab fisheries and reduce potential conflicts among participants that may occur if one quota is used to provide harvesting privileges to two distinct stocks. Alternative 3 would skew the allocation of a harvesters QS to a specific region based on historic catch that may not be reflective of current fishing practices, and could result in increased transaction costs for harvesters to transfer QS or IFQ to fit their current fishing practices.

Alternative 1 for processors would fail to provide an opportunity for processors to establish long term relationships with specific harvesters for specific Tanner crab deliveries. This could increase operational costs. Although none of the alternatives has substantial negative impacts on small entities, preferred Alternative 2 for processors minimizes the potential negative impacts that could arise under Alternatives 1 and 3 for processors by increasing their ability to establish fixed long-term relationships with a harvester for delivery of their IFQ.

Differences in efficiency that could arise among the harvester and processor alternatives are likely to affect most participants in a minor way having an overall insubstantial impact. As a consequence, none of the alternatives is expected to have any significant economic or socioeconomic impacts.

This final rule has been determined to be not significant for purposes of Executive Order 12866.

NMFS has posted a small entity compliance guide on the Internet at http://www.fakr.noaa.gov/sustainablefisheries/crab/crfaq.htm to satisfy the Small Business Regulatory Enforcement Fairness Act of 1996, which requires a plain language guide to assist small entities in complying with this rule. Contact NMFS to request a hard copy of the guide (see ADDRESSES ).